Professional Documents
Culture Documents
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
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 (©2008 and 2013). 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.
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
Operator’s 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 person’s 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.
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 Abbott
trademark, 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.
Instrument/Power related
Symbol Definition/Use Symbol Definition/Use
Alternating Current
AC INPUT PRESS 1 Pressure 1
Input
POWER Power
Use by
HGB Hemoglobin
8
Temperature Limitation (Example shows “Store at 2º–8ºC”)
CAL Calibrator
CALIBRATOR Calibrator
CONTROL Control
PARAMETER Parameter
SYSTEM System
Biological risks
CE-mark
Date of Manufacture
Manufacturer
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
Abbott
Diagnostics Division
EC REP ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580 PN 9231514A
Figure 4: CE Label
9221514A.indd 1 1/16/2008 12:16:45 PM
MODEL MODEL
REF REV
SN
SN
REF REV
PN 9231477A
Figure 9: Biohazard
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
Analyzer Front and Rear. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
System Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Organization of the online HTML Operator’s Manual. . . . . . . . . . . . . 2
Conventions for the online HTML Operator’s Manual . . . . . . . . . . . . 5
Access to the online HTML Operator’s Manual from
the system software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Printed documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Access to the PDF Operator’s Manual from
a stand-alone computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
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
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
Appendix A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Appendix B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Appendix B – Reference. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1
NOTES
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: CE Label for New Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Figure 5: ETL Certification Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Figure 6: Analyzer Serial Number Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Figure 7: CELL-DYN Ruby Service Technical Service Bulletin
Record Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
Figure 8: Laser Warning Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
Figure 9: 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Figure 1.7 Analyzer Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Figure 1.8 Hardware Component Cable and Connection Overview -
Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Figure 1.9 Data Module Computer Component Connections - Rear View . . . 1-23
Figure 1.10 Flat Panel Display (Right Side) . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Figure 1.11 Flat Panel Display (Back Side) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Figure 1.12 Example of Standard English Keyboard. . . . . . . . . . . . . . . . . . . . . 1-25
Figure 1.13 Using the Mouse Input Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Figure 1.14 Hand-Held Bar Code Reader Connection. . . . . . . . . . . . . . . . . . . . 1-28
Figure 1.15 Screen Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32
Figure 1.16 Title Bar Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Figure 1.17 Menu Bar Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33
Figure 1.18 Tool Bar Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35
Figure 1.19 Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38
Figure 1.20 System Messages Region Example . . . . . . . . . . . . . . . . . . . . . . . . 1-39
Figure 1.21 NOTE Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40
Figure 1.22 NOTE Detailed (More Spec Info Window) . . . . . . . . . . . . . . . . . . 1-41
Figure 1.23 QCID Lookup Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-41
Figure 1.24 Function Key Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42
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
Operating Instructions
Figure 5.1 Power Switch Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Figure 5.2 Datalog Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Figure 5.3 Rule Setup Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-51
Figure 5.4 Add new Rule dialog box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
Figure 5.5 Single Record View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-71
Figure 5.6 Printed Specimen Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-72
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
List of Tables
Use or Function
Table 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
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
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
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 . . . . . . . . . . . . . . . 5-21
Table 5.10 Procedure to Edit Pending Orders . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Table 5.11 Procedure to Delete Pending Order Entries . . . . . . . . . . . . . . . . . . 5-29
Table 5.12 Open Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Table 5.13 Closed Mode Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Table 5.14 Datalog Specimen Type Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Table 5.15 Datalog Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-38
Table 5.16 Fields – Rule Setup Dialog Box . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Table 5.17 Buttons – Rule Setup Dialog Box. . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Table 5.18 Procedure: Creating Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-54
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
Hazards
Table 8.1 Safety Icons and Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Table 8.2 Hazard Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
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 . . . . . . . . . . . . . . . . . . . . . . . 11-28
Table 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
Reticulocyte Package
Table 12.1 Known or Potential Interferences . . . . . . . . . . . . . . . . . . . . . . . . . 12-14
Table 12.2 Instrument Alert Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-26
Table 12.3 Data Invalidating Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-27
Introduction
Documentation for the CELL-DYN Ruby consists of the CELL-DYN Ruby
Operator’s Manual, available in both online HTML version and printed versions.
Also available on the install CD in Portable Document Format (PDF).
The Operator’s 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 Operator’s Manual is designed to be the fastest, easiest, and
most user-friendly resource for your informational needs. The online HTML
Operator’s Manual (CELL-DYN Ruby Operator’s Manual) contains the same
content as the printed operator’s manual, which includes complete instructions for
using and maintaining the CELL-DYN Ruby. You can access the online HTML
Operator’s 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 Operator’s Manual
• Conventions for the online HTML Operator’s Manual
• Access to the online HTML Operator’s Manual from the system software
• Access to the online PDF Operator’s Manual for a stand-alone computer
Revision Status and Refer to this section for the Revision Status and History of the
Log CELL-DYN Ruby Operator’s Manual.
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 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 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 operator’s manual about the system.
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
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 Operator’s Manual is organized as follows:
Table 5: Online Operator’s Manual Organization
Revision Status and Refer to this section for the Revision Status and History of the
Log CELL-DYN Ruby Operator’s Manual.
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 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 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 operator’s manual about the system.
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
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
1. Insert the CELL-DYN Ruby Operator’s 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
system’s 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 Operator’s Manual CD-ROM contents
and your laboratory’s 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 Operator’s 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 operator’s
manual.
6. Use any of the optional Acrobat Reader search features to navigate through
the PDF operator’s manual. See Table 5 below for navigation options.
7. Upon completion, remove the CD-ROM from the CD-ROM drive.
Overview
Intended Use
The CELL-DYN Ruby System is a multi-parameter, automated hematology
analyzer intended for in vitro diagnostic use in the clinical laboratories.
Platelet Parameters
• PLT—Platelet concentration
• MPV—Mean Platelet Volume
Hemoglobin Parameters
• HGB—Hemoglobin concentration
• MCH—Mean Cell Hemoglobin
• MCHC—Mean Cell Hemoglobin Concentration
NOTES
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
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.
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 F4—Edit 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:
RETIC Reticulocyte
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
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
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.
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
Intake Fan
The Intake Fan provides air flow through the Analyzer chassis.
1 Intake Fan
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 at least 10 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.
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.
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
l’esposizione 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.
ΠΡΟΣΟΧΗ – Λέιζερ κλάσης 3Β όταν είναι
ανοιχτό. Αποφύγετε την έκθεση στην
ακτίνα.
UPOZORNĚNÍ: Po otevření krytu nebezpečí ozáření
laserem třídy 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)
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.
Waste Chambers
The Waste Chambers collect the liquid waste from the Analyzer flow panel.
Diluent Reservoir
The Diluent Reservoir maintains a Diluent/Sheath Reagent supply for cleaning
and sample dilution.
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.
4
3 1
Figure 1.6 Optical Bench
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
Exhaust Fans
The Exhaust Fans provide air flow through the analyzer chassis.
Ground Connector
See Waste Sensor Jack.
1
4 5
7 2 3 6
5
8 1
3
2 4
Figure 1.8 Hardware Component Cable and Connection Overview - Rear View
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)
User Controls
POWER
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.
Table 1.3 Keyboard Keys and Their Functions on the CELL-DYN Ruby
Press: To:
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.
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.
Alt + Tab Display a dialog that allows the Operator to tab between the open applications,
making the tabbed-to application the active window.
Mouse
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.
1 Keyboard
2 Hand-Held Bar Code
Reader
1 2
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 manufacturer’s 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
NOTES
System Software
Screen Navigation
Screen Layout
These are the main sections as shown in Figure 1.15.
SYSTEM
MESSAGES
REGION
REGION
Title Bar
The purpose of the Title bar is to identify the main view being displayed. The Title
bar also displays the CELL-DYN Ruby’s last run datalog sequence number and the
current date and time.
Menu Bar
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
File
Setup
Calibration
Diagnostics
Help
Sign Off
Tool Bar
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
F4-Edit
F6-Create Order
F3-Find/Filter
F4-Edit
F7-Previous Specimen
F8-Next Specimen
F3-Find/Filter
F4-Edit
F8-Next Specimen
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
F5-Delete All
F6-Create Order
F8-Next Specimen
F4-Edit
F6-New Entry
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.
NOTE: If Status Bar Function Keys become unresponsive, use mouse or touch
screen to access the respective functions via the Status Bar (see
Figure 1.19).
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.
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
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.
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 (0°C) 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
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. 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.
NOTES
Overview
NOTES
Installation
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 Table 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.
• 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.
NOTES
System Customization
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
• 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
Bar Code Setup… • Check digit setup for all symbologies enable/disable
• Auto Transmission
• Manual Transmission
LIS Setup…
• LIS Configuration
• LIS Tests
Logs Auto Backup Set- • Set time for automatic backup of database
up...
Limits tab
Limit Set
Description Comment
Number
2. Select the Next>> button until a message box opens and displays the
message: No Auto Limit Sets; Create new one?
3. Select Yes to create a new Limit Sets. (Selecting No closes the message box.)
The Patient Sample Setup dialog box now displays:
— the next available Limit Set Male with settings of age 0 to 199 years.
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.
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.
Field Description
Limit Default
Set NOTE: Sex not
Name defined, no
field listed in
dialog box
2. Click the Next>> button to view the next Limit Sets and the respective data.
Field Description
Limit 2
Set
Universal Male
3. Click the Next>> button to view the next Limit Sets and the respective data.
Field Description
Limit 3
Set
Sex Female
Universal Female
5. Select Yes and then the M(0,0 -199,0) Limit Set Name opens.
Field Description
Limit 4
Set
Sex Male
M(0,0-199,0)
6. Setup a New Limit Set for a neonate male from age 0 week to 1 week by
entering the following data.
Sex Male
M(0,1-199,0)
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.
Sex Male
M(0,1-199,0)
8. Select the Next >> button and the Patient Sample Setup displays the
following information.
Field Description
Limit 6 — automatically
Set entered
Sex Female
F (0,0-199,0)
9. Enter the following information to create a Limit Set for a neonate female
from age 0 week to 1 week old.
Limit 6 — automatically
Set entered
Sex Female
F(0,1-199,0)
10. Select the Next >> button and next limit set is automatically calculated to
display:
Field Description
Limit 7 — automatically
Set entered
Sex Female
F (0,1-199,0)
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.
NOTE: The Custom Labels for User
Field 1 and User Field 2 must be
unique.
Using the button resets all the Run View Parameter Set settings to the factory defaults.
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
Lab Page
This page is for laboratory use only.
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.
Graphs Page
Graphs
Table 2.8 Procedure to Customize the Run View - Graphs Page
Table 2.9 Procedure to Customize Tab Titles and Column Headings in Data View
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.
Administrative Setup
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
Admin Administrator
Guest Guest
CSC Service
FSE Service
NOTE: CSC and FSE logins are for use only by Abbott personnel.
Operator Accounts
Table 2.15 Procedure to Add an Operator
Operator ID Limited to 6
alphanumeric
characters
Description Optional, 50
characters
maximum
Password 15 character
maximum
Description Optional, 50
characters
maximum
Password 15 character
maximum
Table 2.20 Procedure for Editing Permission Access Rights for Laboratory Levels I and II
Table 2.20 Procedure for Editing Permission Access Rights for Laboratory Levels I and II (Continued)
Date/Time
2. Select the alarm clock or Set Date/Time and the Date - Time Properties
dialog box opens.
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. The default for the daylight savings time (DST) feature is set as “disabled.”
To enable the DST feature, check “Automatically adjust clock for daylight
savings changes” box.
7. Click Apply and OK and the date and time are set.
8. 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 Preferences... 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.
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.
123456789
Table 2.23 Procedure to Set Up Bar Code Including Symbology Setups (Continued)
Orders Setup…
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.
LIS Setup…
Query All
The Query All function directs the CELL-DYN Ruby to periodically send a
message to the host computer requesting download of all outstanding orders. The
frequency of the Query All message can be configured from 1 to 120 minutes.
Selecting the Enable “Query All” checkbox in the LIS Configuration tab view
enables the function.
Host Query
The Host Query function allows the CELL-DYN Ruby to query the host computer
for order(s) for a specific Specimen ID. The function is enabled by selecting the
Enable “Host Query” checkbox in the LIS Configuration tab view. The period of
time (in seconds) that the analyzer will wait for a response from the host computer
can be specified in the Host Query Timeout field.
For more information on the use of the Host Query function, refer to Section 5:
Operating Instructions, Subsection: Specimen Analysis.
Flag Setting…
This customization is used to enable ATYPDEP flagging sensitivity or disable the
ATYPDEP flag. See Section 3: Principles of Operation, Subsection: Data
Flagging.
Set up Time for Auto backup of 1. Select Setup from the menu System automatically backs up the
database bar, Administrative Setup from database daily at the set time. In
the pulldown menu, and Logs addition, the System automatically
Auto Backup Setup… from the backs up the database every hour
extended menu. The Logs from the set time.
Auto Backup Setup dialog box NOTE: The Default daily backup
opens. time is midnight.
NOTE: The CELL-DYN Ruby Software prevents exit from the application and
manual backup of system data during the time that automatic backup is in
process.
Rule Setup...
Rule Setup… is used to create rules and annotations for the Rules Based
Annotations feature. See Section 5: Operating Instructions, Subsection:
Advanced Data Management – Rules Based Annotations.
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.
NOTES
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 µL for the WBC dilution
1.67 µL for the RBC/PLT dilution
12 µL 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 µL 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 µL 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.
Hemoglobin Analysis
1. The Diluent/Sheath Syringe injects 1.7 mL of diluent through the Shear
Valve where the 12 µL 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 µL 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 µL 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 90°D) angles.
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.
Flow Cytometry
3
5 4
Figure 3.1 Optical Bench
WBC Measurement
Overview
The Optical Channel is used for the determination of WBC data. During sample
aspiration, 20 µL 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 µL 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 90°D).
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.
3 5
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
90° Lobularity
Mononuclear-Polymorphonuclear Separation
The scatter information is plotted with the 90° scatter on the Y axis and the 10°
scatter on the X axis. (The 90°/10° scatterplot is shown in the 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.
Neutrophil-Eosinophil Separation
The scatter information is plotted with the 90°D scatter on the Y axis and the 90°
scatter on the X axis. (The 90°D/90° scatterplot is shown in the 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 90°D light. The eosinophils scatter more 90°D
light than any of the other cells because of the unique nature of granules they
contain. This property of the eosinophils is used to positively identify them and
thus clearly differentiate them from the neutrophil population.
Mononuclear Mononuclear
Separation Identification
0° Size
0° Size
Mononuclear Separation
The scatter information is plotted with the 0° scatter on the Y axis and the 10°
scatter on the X axis. (The 0°/10° scatterplot is shown in the 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.
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.
90°D/0°
The scatter information is plotted with the 90°D scatter on the Y axis and the 0°
scatter on the X axis.
90°D/10°
The scatter information is plotted with the 90°D scatter on the Y axis and the 10°
scatter on the X axis.
All scatterplots may be displayed and printed at operator request.
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 0º/10º 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.
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 operator’s
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.
WBC Parameters
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/µL
NEU # x 10e3/µL and %
LYM # x 10e3/µL and %
MONO # x 10e3/µL and %
EOS # x 10e3/µL and %
BASO # x 10e3/µL and %
The decimal point moves to display up to three decimal places for the absolute
number and percent.
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 µL 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 µL 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.
RBC Parameters
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/µL
Counts below 1.0 x 10e6/µL 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
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.
PLT Count
The PLT count is expressed as thousands per microliter (10e3/µL).
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.
Hemoglobin Measurement
Overview
The HGB channel is used for the colorimetric determination of hemoglobin.
During sample aspiration, 12 µL 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.
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.
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.
WBC 7.23
1 NEU 4.65
2 LYM 1.67
3 MONO .639
4 EOS .228
5 BASO .045
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
NOTES
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 laboratory’s 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.
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 0º / 10º 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.
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 (*)
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 (LB) BASO, LYM, %B, %L BASO, LYMe, VARL, %B, %Le, %VL
MCHC RBC, HGB, HCT, MCV, MCH, MCHC, RBC, HGB, HCT, MCV, MCH, MCHC†,
RDW, PLT, MPV RDW, PLT, MPV, PDW, PCT
Instrument and
Parameters marked with an asterisk (*) Parameters marked with an
Data Invalidating
on Chartable Page asterisk (*) on Lab Page
Alerts
WOC Heater Error WBC (If WOC is chosen), NEU, MONO, WBC (If WOC is chosen) SEG, BAND,
EOS, BASO, LYM, %N, %M, %E, %B, %L, IG, BLST, MONe, EOS, BASO, LYMe,
%R, RETC VARL, %Se, %BD, %IG, %BL, %Me,
NOTE: WBC and WOC are asterisked for %E, %B, %Le, %VL, %R, RETC
all cases except for runs with a NOTE: WBC and WOC are asterisked
Specimen Type of Patient and the for all cases except for runs with
CBC + NOC Test Selection, where a Specimen Type of Patient and
the WBC value always comes the CBC + NOC Test Selection,
from the NOC. where the WBC value always
comes from the NOC.
Reticulocyte
Instrument and Parameters marked with an asterisk (*) Parameters marked with an
Data Invalidating on Chartable Page asterisk (*) on Lab Page
Alerts
WOC Flow Error WBC (If WOC is chosen), NEU, MONO, WBC (If WOC is chosen), SEG, BAND,
EOS, BASO, LYM, %N, %M, %E, %B, %L IG, BLST, MONe, EOS BASO, LYMe,
VARL, %Se, %BD, %IG, %BL, %Me,
%E, %B, %Le, %VL
RBC Flow Error RBC, MCH, HCT, MCHC, PLT, MPV, MCV, RBC, MCH, HCT, MCHC, PLT, MPV,
RDW PCT, PDW, MCV, RDW
NOC Flow Error WBC (If NOC is chosen), NEU, MONO, WBC (If NOC is chosen), SEG, BAND,
EOS, BASO, LYM, %N, %M, %E, %B, %L IG, BLST, MONe, EOS, BASO, LYMe,
VARL, %Se, %BD, %IG, %BL, %Me,
%E, %B, %Le, %VL
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.
3-32 CELL-DYN Ruby System Operator’s Manual
9140547D—September 2013
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
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
laboratory’s 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/µL 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 cell differential values.
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 laboratory’s 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.
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 laboratory’s review
1. The CV of the neutrophil cluster on the criteria.
0 axis exceeds expected criteria. NOTE: When bands are present, they are
2. %BAND > 12.5% of the total WBC included in the total neutrophil count.
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 laboratory’s 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 laboratory’s 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 laboratory’s
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.
Descriptor/
Cause Suggested Action
Flag
LRI* 1. Interference in the lower threshold region A. Repeat the specimen. If the flag persists,
(2fL–3fL) > 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
(15–35fL) > 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
NOTE: URI may be caused 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 laboratory’s 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
Setting….
* These flags are also triggered in the CBC+NOC and CBC+RRBC test selection when there is no significant
difference between WOC and NOC.
(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 laboratory’s 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 laboratory’s 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 laboratory’s 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 laboratory’s 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 laboratory’s 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.
(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.
NOTE: When processing samples in the CBC+RRBC or CBC+NOC test selections, a correction to the
Lymphocyte count may be performed. If during this correction the differential does not meet software
criteria the differential will be suppressed.
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
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
References
NOTES
Overview
NOTES
Specifications
Physical Specifications
Physical specifications for the CELL-DYN Ruby are provided in the following
table.
Table 4.1 CELL-DYN Ruby Physical 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
Analyzer 100 - 240 VAC 50/60 Hz 5.0 - 2.2 amps 550 watts
Printer For power specifications for printers, refer to the operator’s manual for your printer or
other documentation received with your printer.
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.
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
Operational Specifications
Maximum Throughput (Closed Mode)
CBC: 84 specimens/hr†
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.
Table 4.7 Recommended Specimen Collection Tubes for use in Closed Mode
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.)
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
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 &.
59
2 3 4 5 6
Figure 4.3 Tube with Correctly Positioned Bar Code Label in a Sample Loader
Rack
• Use the bar code symbology Code 128 specified by the Clinical and
Laboratory Standards Institute CLSI.1
• 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.
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 System’s 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
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.
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:
Target Values†
Parameter % Carryover
(USA)
† 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.
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/µL. 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 Reticulocyte Carryover
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
WBC (WOC) 4.4 – 9.5 X 103/µL 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
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.
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
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 Abbott’s 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
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.
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.
References
NOTES
Overview
NOTES
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 manufacturer’s 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.
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
Initialized state, press F12 – Prime turned back ON. Do not process
to prime the system and run an Auto samples during this warm-up
Background. period.
NOTE: Verify background count results
are within acceptable limits prior
to running controls or patient
specimens.
Table 5.2 Procedure to Power-up the Instrument When the System Main Power Switch is in OFF Position
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,
Shutdown…from 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 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.
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
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
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
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
Setup Guidelines
Setup Guidelines
The following table summarizes the tasks involved to configure your System to
your laboratory’s requirements. See Section 2: Installation Procedures and
Special Requirements, Subsection: System Customization for more details.
NOTES
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).
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 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.
Prepare, run, and verify controls. Handle controls as directed on the manufacturer’s 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.
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.
The stability of capillary samples may vary depending on the collection device
manufacturer. Refer to the collection tube manufacturer’s package insert for
stability claims.
Specimen Collection
All specimens should be collected using proper technique and following the tube
manufacturer’s 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 manufacturer’s 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 laboratory’s 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
manufacturer’s 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.
NOTE: Ensure that CAPS Lock on the keyboard is OFF when using the
Hand-Held Barcode Reader.
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 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.
Identify specimens Label tubes with bar code labels. Refer to Section 4: Performance
Characteristics and Specifications,
Subsection: Bar Code Specifications.
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.
Host Query
If no match for a Specimen ID is found in the current Orders list, the Host Query
function allows an operator to query the host computer for an order for that
Specimen ID.
Closed Mode
After the tube barcode is read, the Orders list is searched for a match. If no match
is found, and Host Query is enabled, the Ruby will automatically query the host
computer for an order for that Specimen ID. If a new order is found, the processing
instructions in the order will be used for the specimen. If no new order is found with
Host Query, the specimen is processed using the default Patient Test Selection.
Open Mode
When a tube barcode is scanned or entered in the NOTE region, the Orders list is
searched for a match. If no match is found and Host Query is enabled, the Host
Query Button will be active in the NOTE region. Selecting the button will query
the host computer for an order for that Specimen ID. If a new order is found, the
processing instructions in the order will be used for the specimen. If no new order
is found with Host Query, the specimen is processed using the default Patient Test
Selection.
NOTE: If a match for the Specimen ID is found in the Order list, the “Matched”
indicator replaces the Host Query button.
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
Groups View
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.
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.
View and edit Repeat procedure, starting from Task: Selects additional Pending Order for
additional records Specify record to edit, above. editing.
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 from the
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 from the menu
items.
3. Select Yes button in Message dialog
box to confirm deletion.
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 or 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
demographic 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.
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.
NOTES
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 parameter’s 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 -------.
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.
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 at the end of the cycle in process.
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.
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 at the end of the cycle in process.
NOTE: WBC and WOC are asterisked for all cases except for runs with a
Specimen Type of Patient and the CBC + NOC Test Selection, where the
WBC value always comes from the NOC.
Run View
For customization of the Run view see Section 2: Installation Procedures and
Special Requirements, Subsection: Customize Run View….
Chartable Page
Lab Page
Graphs Page
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.
NOTE: After a QCID has been deleted (either QC Whole Blood or QC
Commercial) the data log will show:
– Specimen ID: “Deleted_QCID”
– Original Specimen ID: <blank>
– Draw Date: <blank>
– Draw Time: <blank>
– Lot Number: <blank>
– Expiration Date: <blank>
– Parameter set: “1”
Data in fields other than those noted are unaffected by the QCID deletion.
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.
Patient
QC-Commercial
QC-Wholeblood
QC-Background
Auto-Background
SRP-LATEX
AutoCalibration - Calibrator
AutoCalibration-WholeBlood
Prints the selected record or a range Print Summary View or print Single
F1—Print of records Specimen View report for each record in
selected range.
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
listing from black to red.
F4—Edit
A red sequence number indicates a
flagged item.
NOTE: If changes do not match
existing patient limits, a
checkbox displays asking the
operator to verify the request.
Opens the Reorder Entry dialog box Completing the Reorder Entry
information and selecting OK sends the
F6—Create Order Reorder Entry information to the
NOTE: Becomes Pending Orders queue in Orders.
available after F7—View
Specimen in the Datalog
view is selected.
F7—Previous 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 F7—View
Specimen in the Datalog
view is selected.
F8—Next 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 F7—View Datalog list. has been selected.
Specimen in the Datalog
view is selected.
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.
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:
“The application will now be restarted, allowing the restore process to
complete. This may take several minutes. Please ensure that the CD or floppy
diskette has been removed, and then select OK.”
8. Select OK. 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.
PROCEDURE: SELECTING THE MEDIA YOU WISH TO USE FOR SAVING (FLOPPY
DISK OR USB MEMORY STICK)
1. Insert an empty 3½ inch floppy disk into the floppy drive.
2. If you don’t have a floppy drive on the PC you are using to archive, you may
use a Windows compatible USB memory stick. Insert the USB memory stick
into the USB port (located at the back of the analyzer). Or you can use an
appropriate USB 2.0 Type A/B Extension Cable with a USB memory stick.
5. From the “Save in” pull down menu select the A: drive if you are using a
floppy disk, or the appropriate drive for a USB memory stick.
6. Select the range of records you want to save, entering the numbers in the
Start SEQ# and End SEQ# fields.
7. Name the file whatever you desire.
8. Press Save.
9. When the save is complete, remove the floppy disk from the disk drive or the
USB memory stick.
NOTE: “Save Records” procedure as shown in steps 2-9 above may be
used to save records from other logs (for example: Event,
Maintenance and Reagents).
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.
NOTE: 1. If LIS transmission is set up to automatically transmit ALTERED
specimens, flagged specimens will not be added to the NRBC/RRBC,
FWBC, or Exceptions groups.
2. If “Strict Specimen ID Validation” is enabled in LIS setup, any
specimen without a valid Specimen ID will not be transmitted and will
appear in the Not Transmitted group.
Records can be manually deleted from the Groups view using the following
procedures.
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.
NOTES
The Rules Based Annotation feature allows a user to specify text annotations that
will appear on the Single Record View and printout. Annotations display based on
evaluation of user-created rules, which use specimen result and/or demographic
criteria. The Rules Based Annotation feature is provided as an option to assist in
laboratory workflow.
IMPORTANT: Any invalid specimen result must be verified according to the
laboratory’s protocol before being reported. Use of rules based
annotations does not eliminate the requirement for confirmation of
invalid results.
• Up to 100 rules and 48 annotations may be created. Rules may be created by
a user with admin access level.
• Individual rules can be enabled or disabled, and there is also the ability to
enable/disable the entire set of rules.
• The software provides the ability for the user to verify that any single rule
performs as expected, and also that all enabled rules perform as expected.
NOTE: Each laboratory is responsible for validating rules before use.
The process for creating rules and annotations, and the other functions of the Rules
Based Annotation feature are discussed in the sections that follow.
Rule Setup Dialog Box
Rules related functions are managed from the Rule Setup dialog box (Figure 5.3).
Fields Description
Rule Lists the current Rules set and indicates enabled/disabled status
Rule Expression Displays the specific expression for the selected rule
Buttons Description
Edit Rule Opens the Edit Rule dialog box for the selected rule
Validate Selected Rule Opens the Rule Validation dialog box, displays value fields for selected rule
Opens the Rule Validation dialog box, displays value fields for all enabled
Validate Enabled Rules
rules
Import Allows transfer of rule setup from another analyzer on portable media
Creating Annotations
Selecting the Annotation Setup button from either the Rule Setup or Add New
Rule dialog box (Figure 5.4) will open the Annotation Setup dialog box. The
maximum number of annotations is 48. Each annotation may contain a maximum
of 54 characters. Up to 15 annotations may be associated with a rule.
Open the Add 3. Select the Create Rule The Add New Rule dialog box opens:
New Rule button.
dialog box
Add the New 11. Select the OK button to The Add New Rule dialog box closes. The new rule is
Rule add the new rule. displayed in the list in the Rule Setup dialog box.
Open the 1. From either the The Annotation Setup dialog box displays:
Annotation Rule Setup or
Setup dialog Add New Rule
box dialog box,
select the
Annotation
Setup button.
Open the Add 2. Select the Add The Add New Annotation dialog box displays:
New button.
Annotation
dialog box
Add new 3. Type in the The new annotation is added to the annotation list and the Add New
annotation annotation and Annotation dialog box closes.
click OK.
Rules and annotations may be moved up and down in their respective lists by
dragging and dropping the rule or annotation in the desired location.
Enabling/Disabling Rules
Individual rules are enabled/disabled by checking or unchecking the box next to the
rule in the rule list.
Checking the “Check this box to enable rules” box at the top of the Rule Setup
dialog box enables the entire set of rules. This checkbox is unchecked during rule
creation.
NOTE: If the unit set is changed from the current configuration, the rules status is
automatically set to “disabled”. Rules containing numeric values may be
affected by a change to the unit set.
A message indicating that the change in units may impact rules is
displayed.
Example Rules
The following example rules are provided for illustration purposes only. The user
should develop and validate rules appropriate for their laboratory.
For each example, the “Rule Expression” is entered in the IF field in the Add New
Rule dialog box. The annotation is entered in the THEN field in the dialog box.
Example Rule 1: Single data element
The laboratory wishes to have the annotation “Review Slide” appear on records for
specimens with a WBC count greater than 15.0.
Rule Expression: WBC >15.0
NOTE: Rules that have been edited should be re-validated to verify that the rule
evaluates as expected after the change.
To edit an annotation, select the Annotation Setup button from the Rule Setup,
Add New Rule, or Edit Rule dialog box. The Annotation Setup dialog box
opens:
Highlight the annotation to be edited, and select the Edit button. If the highlighted
annotation is currently assigned to a rule or rules, the following message appears:
Select Yes to continue editing the annotation, or No to cancel the edit and return to
the Annotation Setup dialog box.
To delete all rules, select the Delete All Rules button. A message will appear
asking you to confirm the deletion. Select Yes to delete all rules.
To delete an annotation, open the Rule Setup dialog box and select the Annotation
Setup button. The Annotation Setup dialog box opens:
Highlight the annotation to be deleted and select the Delete button. If the
annotation is used in one or more rules, a message will appear in the bulletin line:
The annotation must first be removed from any rule in which it is used before it can
be deleted. Use the Edit Rule function to remove the annotation, then return to
Annotation Setup. Highlight the annotation and select the Delete button. A
confirmation window appears:
To delete all annotations, select the Delete All button. If any of the annotations are
associated with current rules, the annotation(s) must be removed from the rules as
described above before they can be deleted.
2. The Rule Validation dialog box displays the rule expression elements for
each enabled rule. Enter appropriate values in the value field next to each
element, and select the Validate Rule button. Each rule is evaluated, and the
Rule Evaluation Results display.
3. Verify the evaluation results and repeat testing if needed.
NOTE: When validating all enabled rules, the Validation Comments and
Validation Status fields are active only when all rules have the same
status, i.e., all rules passed or all rules failed. If the status is not the same
for all rules, these fields are inactive.
4. Select the Print Report button to print the validation report. The validation
report for all enabled rules will contain the same information displayed in the
Rule Validation dialog box, plus all the information in the rules report.
(Refer to Printing the Rules Set later in this section).
Displaying Annotations
Annotations are displayed in the Run View and Single Specimen View on the
Laboratory Page, and appear as one line per annotation in the lower right region of
the display and printout. If an annotation appears for a specimen record, graphs 5
and 6 will not be shown.
Up to 15 annotations can appear on the display and printout. If rule evaluation
results in more than 15 annotations for a given record, only the first 15 annotations
will be displayed.
NOTE: You can also open the Print dialog box by pressing the F1 function
key, Print.
5. Select Print
6. When the Print dialog appears, select All, Print as Single Specimen View
and Lab.
3. Select the target location (floppy drive, USB drive) and click OK. The
bulletin line displays a message when export has completed successfully.
4. When Export is complete, remove the transfer media.
3. Select the target location (floppy drive, USB drive) and click OK. The
bulletin line displays a message when import has completed successfully.
4. When Import is complete, remove the transfer media.
NOTES
Overview
NOTES
When to Calibrate
NOTES
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.
Calibration Materials
The CELL-DYN Ruby System requires commercial calibrator material or assayed
whole blood for calibration.
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.
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.
WBC > 1.99 – < 25.0 x 109/L > 1.99 – < 25.0 x 103/µL
RBC > 2.00 – < 6.50 x 1012/L > 2.00 – < 6.50 x 103/µL
HGB > 70.0 – < 150.0 g/L > 7.00 g/L – <15.0 g/dL
PLT > 50.0 – < 600 x 109/L > 50.0 – < 600 x 103/µL
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.
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.
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.
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 parameter’s %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.
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 parameter’s %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.
Calibration Notes
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NOTES
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.
This area is
blank if there
is no previous
data
Field Description
Run results
Data analysis
of run results
Field Description
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
Buttons Description
New Precision Check Clears the data to begin a new precision check
NOTE: The Quick Precision Check will be cancelled by the software if any of the
following System Events occur:
• Fault requiring initialization of software.
• Reagent related operator correctable faults (except Waste Full).
• Processor Tower Cover Open operator correctable fault (Open Mode).
• Sample Loader related operator correctable faults.
NOTE: A run will not be accepted into the Quick Precision Check if it has a
Sampling Error fault.
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)
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
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:
Table 6.5 Fields — Calibration Log View
Field Description
Buttons Description
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 specimen runs for calibrator.
• For whole blood specimens the number of allowed specimens, runs per
specimen and total number of specimens allowed is as follows:
1) A minimum of 2 and a maximum of 5 different whole blood specimens
is required.
2) The number of runs per specimen must be a minimum of 2 and a
maximum of 5 so that the number of total runs is between 6 and 20.
• 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.
Field Description
Buttons Description
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
Beginning Auto-Calibration
1. Verify the System is in Open Mode. If the System is in Closed Mode select
the F11—Select 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.
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.
Buttons Description
Table 6.10 Buttons — Pre-Calibration Maintenance Check Status Dialog Box (Continued)
Buttons Description
Buttons Description
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
Buttons Description
Verify that the results of the last precision check are not greater than 24 hours
old and the Status column lists PASS, 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.
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.
Buttons Description
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.
Buttons Description
• 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.
Fields Description
Table 6.16 Buttons — Calibration Setup - Reference Values for Calibration Dialog
Box
Buttons Description
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.
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
Field Description
Apply New Factor Applies the new factor to the next screen
Buttons Description
% 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%
Table 6.20 When to Select Apply New Factor for Acceptance (Continued)
Select <YES> to continue. The Open/Closed Mode Bias Start dialog box opens.
Buttons Description
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.
8. Click Print to print out and review the calibration summary report.
Buttons Description
Buttons Description
Buttons Description
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
Buttons Description
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
6. Click Next> and the Pre-Calibration Background Check Status dialog box
opens and starts the Auto Background cycle.
The green light and the word Ready appear in the State field when the Pre-
Calibration Background Check is completed.
Buttons Description
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.
Buttons Description
Table 6.27 Buttons — Calibration Setup - Reference Values for Whole Blood
Dialog Box
Buttons Description
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 parameter’s 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.
Click Add . . .
Reference
Values entered
in the
Calibration
Setup dialog
box
Buttons Description
The reference values entered in the prior step appear in the Auto-Calibration
Data View.
The Run# field displays the number of:
• Run# X/x–Completed 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.
Field Description
Apply New Factor Applies the new factor to the next screen
Buttons Description
% 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%
Table 6.31 When to Select Apply New Factor for Acceptance (Continued)
Buttons Description
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.
8. Click Print to print out and review the calibration summary report.
You will need 6 to 10 fresh, normal whole blood specimens to perform the Open/
Closed Mode Bias Check, using the Calibration Bias Wizard.
1. Select Calibration Bias Wizard… from the pull-down Calibration menu.
The Calibration Bias Wizard dialog box opens, showing the Welcome
screen. Select the Primary Sample Mode.
Verify that the results of the last precision check are not greater than 24 hours old
and the Status column lists PASS 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
8. Select Next. The Open/Closed Mode Bias Runs dialog box opens.
9. If you do not use 6 (minimum) closed specimens and you select Next, an
error message displays in the bulletin line at the bottom of the dialog box.
10. Select Next to display the Open/Closed Mode Bias Results screen.
14. Click Print to print out and review the calibration summary report, or click
Finish to exit the Calibration Bias Wizard.
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.
Post-Calibration Procedures
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.
3. Place a labeled floppy disk (at least one megabyte) in the disk drive.
4. In the Backup to floppy field, select the Start Backup button. The dialog
box will indicate the status.
NOTE: If there is not enough space on the disk the message: “Not enough space
for backup on the floppy disk” displays.
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.
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.
WOC / x = 0.700–1.300
NOC / x = 0.700–1.300
RBC / x = 0.800–1.200
HGB / x = 0.700–1.300
MCV / x = 0.700–1.300
PLT / x = 0.700–1.300
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.
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 % 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.
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.
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.
References
NOTES
Overview
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, x-ray
equipment, and copiers.
NOTE: The CELL-DYN Ruby has been evaluated to EN 55011 and
EN 61000 for electromagnetic emissions and immunity,
respectively.
• 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.
• 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 (500µL)
in standard collection tubes, and 0.18 mL (180µL) in micro-collection tubes.
Refer to Section 4: Performance Characteristics and Specifications,
Subsection: Recommended Volume Requirements in Specimen Collection
Tube.
• 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
collection.1
• A higher incidence of false positive morphological flags may occur for
specimens analyzed at higher ambient temperatures within the operating
range of 15C to 30C (59F to 86F). The reported numerical results are not
affected.
• 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 (2–8C) 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 manufacturer’s
package insert.
For a detailed description of the flags that are generated, refer to Section 3:
Principles of Operation, Subsection: Operational Messages and Data Flagging.
Reference
NOTES
Section 8 Hazards
Overview
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.
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.
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.
This symbol indicates that some of the component(s) in the product has Harmful (Xn) or
Irritant (Xi) properties.
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.
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 Pathogens.1 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.
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 manufacturer’s 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.
For information related to Article 33 of the EU REACH regulation
(EC No.1907/2006), please refer to http://pmis.abbott.com/pmis/home.html.
WARNING: This product contains chemicals known to the State of
California to cause cancer and/or birth defects or other reproductive harm.
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.
Disposing of Batteries
The European Battery Directive requires separate collection of spent batteries,
aiming to facilitate recycling and to protect the environment.
This device contains batteries that are not intended to be serviced or removed by
the user. The batteries in this product should be removed at the end of the life of the
device by an Abbott Service technician or a qualified individual, and disposed in
accordance with local regulations for separate collection of spent batteries.
Your local Abbott product support office may be contacted for additional
information.
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 61010-1.5 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.
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.
During operation of the CELL-DYN Ruby, the operator is potentially exposed to the following:
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.
Physical Hazards
Safe practices should be observed to avoid physical injury in the following
situations:
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.
References
NOTES
Overview
NOTES
As-Needed Procedures
Nonscheduled Procedures
Decontamination Procedures
Printer Cleaning
Reagent Container
Replacement
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.
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
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 operator’s 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
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
operator’s 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: 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.
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.
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 system’s
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.
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:
Information
Warning
Fatal Fault
Edit/Change
F1 – Print
F1 – Print can be selected to display the Print dialog box while in the Event Log
view.
These print options can be selected:
• Record range: (1) All (2) Selection and (3) Start Rec# End#.
• Number of copies.
F3 – Find/Filter
F3 – Find/Filter can be selected to display the Find/Filter dialog box that allows
you to search and sort the information contained in the log.
Refer to Section 5: Operating Instructions, Table 5.15 for more details on its use.
F1 – Print
NOTE: The Set Point Log can only be printed using the Print Scrn button from
the keyboard to obtain a printout of what is displayed. While F1 – Print
can be selected in the Set Point Log view, the software will continue to
notify you to adjust the layout before the system can print this log because
the number of columns exceeds the printer page orientation of both
Portrait and Landscape printing.
F3 – Find/Filter
F3 – Find/Filter can be selected to display the Find/Filter dialog box that allows
you to search and sort the information contained in the log. Refer to Section 5:
Operating Instructions, Table 5.15 for more details on its use.
Reagents View
The CELL-DYN Ruby System software provides a user-friendly interface for
viewing System reagent volume status, creating a new reagent entry, and tracking
the history of reagent usage on the instrument.
The Reagents view provides access to tabs:
• Current Reagents
• Reagent Log
Current Reagents
The Current Reagents tab of the Reagents view displays a graphical
representation of the percentage of reagent remaining for each reagent installed on
the system. Whenever the System or operator performs any function that uses
reagent, such as maintenance, calibration, and specimen processing, the amount of
reagent used will be mathematically subtracted from percentage of reagent
remaining and will update the graphical display. The System software provides an
early warning message based on this calculation when each reagent used on the
system has less than ten percent left.
NOTE: This calculation is only an approximation.
NOTE: If replacing reagents on the System before a reagent empty message is
generated, it is important for the operator to create an associated New
Reagent Entry for the reagent replaced to maintain an up to date Current
Reagents view volume status.
After replacing the reagent, select Maintenance View, Special Protocols, Prime,
to move the new reagent into the system.
The Current Reagents view also displays for each reagent used on the System:
• Lot Number: lot number of the reagent container.
• List Number: reagent product number.
• Package Size: reagent container configuration volume.
• Expiration Date: reagent expiration date (YYYY/MM/DD).
• Open Date: date the container was placed on the System.
• Comment: operator entered comment remarks.
F1 – Print
NOTE: The Current Reagents view can only be printed using the Print Scrn
button from the keyboard to obtain a printout of what is displayed. While
F1 – Print can be selected to display the Print dialog box while in the
Current Reagents view, when the OK button is selected, no printout will
be generated.
F6 – New Entry
F6 – New Entry can be selected to display the New Reagent Entry dialog box that
allows you to document new reagent replacement.
Refer to Subsection: Nonscheduled Maintenance Procedures, Reagent
Container Replacement for more details on its use.
Reagent Log
The Reagent Log tab of the Reagents view is used by the operator to track the
history of reagent usage by the instrument.
The Reagent Log displays:
• Rec #: reagent log record number.
• Reagent: name of the reagent.
• % Left: calculated percentage of reagent available in the current container.
• Size: reagent container configuration volume.
• List Number: reagent product number.
• Lot Number: lot number of the reagent container.
• Exp Date: reagent expiration date. (YYYY/MM/DD)
• Open Date: date the container was placed on the System.
• OPID: operator ID when the new reagent entry was created.
• Comment: operator entered comment remarks when the new reagent entry
was created.
NOTE: The comment field can be edited by either double-clicking on the record
or selecting F4 – Edit to display the Edit Reagent Entry dialog box.
The Reagent Log can store up to 10,000 records. After 10,000 records have been
reached, the oldest record is deleted when a new record is added.
F1 – Print
F1 – Print can be selected to display the Print dialog box while in the Reagent
Log view.
These print options can be selected:
• Record range: (1) All (2) Selection and (3) Start Rec# End#.
• Number of copies.
F3 – Find/Filter
F3 – Find/Filter can be selected to display the Find/Filter dialog box that allows
you to search and sort the information contained in the log.
Refer to Section 5: Operating Instructions, Table 5.15 for more details on its use.
F4 – Edit
F4 – Edit can be selected to display the Edit Reagent Entry dialog box for the
record selected and allows you to make changes to:
• Lot Number: lot number of the reagent container.
• Expiration Date: reagent expiration date.
F6 – New Entry
F6 – New Entry can be selected to display the New Reagent Entry dialog box that
allows you to document reagent replacement.
Refer to Subsection: Nonscheduled Maintenance Procedures, Reagent
Container Replacement for more details on its use.
Users can delete reagent log(s) by selecting the log(s), and then using the right
mouse click to display a menu. The menu displays the following actions:
• Save Records…
• Copy Selection
• Copy All
• Print
• Print Preview…
• Delete Selection
Select Delete Selection. A confirmation dialog box displays, asking Delete
Selected Reagent Entry/s? Select Yes or No.
If you select Yes, a second confirmation dialog box displays, asking Confirm to
delete selected Active Reagent Entry/s? Select Yes or No. If you select Yes, the
selected reagent log(s) is deleted.
6001 – Auto-Clean
Perform this scheduled daily maintenance procedure to:
• Clean the Shear Valve and associated fluidic system.
CAUTION: This activity presents a chemical-related hazard. Refer to
Section 8: Hazards, Subsection: Chemical Hazards.
The Auto-Clean Cycle is a fully automated cycle designed to clean the Shear
Valve, RBC/PLT Mixing Chamber, the WBC Mixing Chamber, the Optical Flow
Cell, the HGB Flow Cell, Open Mode Probe, the Closed Mode Needle, and all the
associated fluidics. The forward and reverse action of the peristaltic pump is used
during this cycle to gently scrub and remove any fibrin or debris within the system.
NOTE: The Auto-Clean cycle should be run prior to performing any maintenance
procedure. This ensures that all waste is purged from the fluid pathways.
The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, Scheduled tab.
Replacement parts NA
Preparation in 6001 - Auto-Clean 1. Select Auto-Clean task button. NOTE: Selecting the Cancel
dialog box. button in this dialog box
2. Aliquot 2 mL Enzymatic
will not log the task.
Cleaner into empty tube.
Aspirate Enzymatic Cleaner and 1. Hold the tube up until the tip of When Auto-Clean cycle is
Begin Auto-Clean cycle the open probe touches the complete, three background
bottom of the tube and select counts are automatically run, logs
the Start Auto-Clean button. the activity to the Maintenance
NOTE: Do not remove the tube Log and closes the 6001 - Auto-
until you hear an audible Clean dialog box.
beep. Aspiration will take
90 seconds.
2. (Optional) Enter comments in
the <Enter Comment:> field.
NOTE: Comments are
automatically saved to the
Maintenance log view
when Auto-Clean cycle is
complete.
Verify Background Results 1. Ensure background results are See Section 4: Performance
within acceptable limits before Characteristics and Specifica-
running controls or patient tions, Subsection: Performance
specimens. Specifications.
Blood spills in the Sample Loader track or racks should be cleaned up immediately
to allow proper movement of the racks. Weekly cleaning is recommended when the
Sample Loader is used, but more frequent cleaning may be indicated by the
laboratory workload.
The Analyzer Status must be in the Ready State and in the Open or
Prerequisite
Closed Mode. Maintenance view, Scheduled tab.
Replacement parts NA
Preparation in 6002 - Clean 1. Select Clean Loader NOTE: Selecting the Cancel
Loader Components dialog box Components task button. button in this dialog box
will not log the task.
2. Select Disable Analyzer
button. Disables Analyzer for cleaning.
3. When Analyzer Status
indicates Maintenance State
remove the Processor Cover.
Clean Sample Loader Tray 1. Wipe off Sample Loader tray NOTE: See Decontamination
surfaces with cleaning solution. Procedures for the
formula used to prepare
this solution.
Clean Sample Loader Racks 1. Wipe or rinse racks using NOTE: Do not soak racks.
cleaning solution followed by Soaking may impact rack
DI water rinse. Dry racks. bar code label adhesion
and fade the bar code
imprint over time.
Clean Tube Grippers and Tube 1. With the Mixhead in the home NOTE: This procedure can be
Spinner - Procedure 1 position, wipe out the gripper used for routine cleaning.
surfaces using the DI water If more extensive
and cotton swabs. cleaning of the Tube
Grippers is needed, follow
2. Wipe the tube spinner surfaces
Procedure 2.
using the cleaning solution and
cotton swabs.
3. Replace the processor cover.
4. Proceed to Action:
Maintenance Activity
Completion
Maintenance Activity Completion 1. Select Enable Analyzer Enables the Analyzer to Ready
button. State, logs the activity to the
2. (Optional) Enter comments in Maintenance Log and closes the
the <Enter Comment:> field. 6002 - Clean Loader
3. Select Log Task Complete Components dialog box.
button to indicate the task has
been performed.
NOTE: Selecting the Cancel
button in this dialog box
will not log the task.
The Analyzer Status must be in the Ready State and in the Open or
Prerequisite
Closed Mode. Maintenance view, Scheduled tab.
Tools/materials required NA
Replacement parts NA
Preparation in 6003 – Inspect 1. Select Inspect Syringes task NOTE: Selecting the Cancel
Syringes dialog box. button. button in this dialog box will not log
2. Open the Right Front Cover. the task.
Maintenance Activity Completion 1. (Optional) Enter comments in Enables the Analyzer to Ready
the <Enter Comment:> field. State, logs the activity to the
2. Select Log Task Complete Maintenance Log and closes the
button to indicate the task has 6003 – Inspect Syringes dialog
been performed. box.
NOTE: Selecting the Cancel
button in this dialog box
will not log the task.
Constant pressure on the tubing under the Peristaltic Pump Wheel tends to flatten
the tubing, thereby inhibiting the flow of liquid past the pump. Use this procedure
to replace the Transfer Pump Tubing.
The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, Scheduled tab.
Preparation in 6005 1. Select Replace NOTE: Selecting the Cancel button in this dialog box
– Replace Transfer Pump Tubing will not log the task.
Transfer Pump task button.
Tubing dialog box 2. Select Disable Disables Analyzer for tubing replacement.
Analyzer button.
3. Open the Left Front
Cover.
Maintenance 1. Select Enable Enables the Analyzer to Ready State, logs the activity to
Activity Completion Analyzer button. the Maintenance Log and closes the 6005 – Replace
2. (Optional) Enter Transfer Pump Tubing dialog box.
comments in the <Enter
Comment:> field.
3. Select Log Task
Complete button to
indicate the task has
been performed.
NOTE: Selecting the
Cancel button in
this dialog box will
not log the task.
Cleaning of the Shear Valve ensures optimum performance. Any reagent or blood
residue may cause the valve to leak or function improperly.
NOTE: The center section is not connected by tubing and must be handled
carefully, as it will break if it is dropped. Care should be taken to avoid
chipping, scratching or otherwise damaging any of the sections. Do not
disconnect any of the tubing connected to the front and rear sections.
The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, Scheduled tab.
Replacement parts NA
Preparation in 1. Select the Clean Shear Valve NOTE: Selecting the Cancel button in this dialog box
6006 – Clean task button. will not log the task.
Shear Valve 2. Select Clean Shear Valve Disables Analyzer and unlocks the shear
window. button. valve for cleaning.
3. Remove the Processor Cover.
Maintenance 1. Select Restore Shear Valve Enables the Analyzer to Ready State, logs the activity
Activity button. to the Maintenance Log and closes the 6006 – Clean
Completion 2. (Optional) Enter comments in Shear Valve dialog box.
the <Enter Comment:> field.
3. Select Log Task Complete
button to indicate the task has
been performed.
NOTE: Selecting the Cancel
button in this dialog box
will not log the task.
The Diluent/Sheath Filter is located on the left front flow panel to the left of waste
chamber #3. Replace the filter once a month, or whenever contamination is
suspected. A sign of contamination is usually manifested by high platelet
background, poorly defined PLT-RBC (0°/10°) scatterplot, excessive WBC
flagging, or erroneous 5-part differential results. Refer to Section 10:
Troubleshooting and Diagnostics, Subsection: Troubleshooting Tips and
Techniques for more details.
The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, Scheduled tab.
Preparation in 6007 – 1. Select Replace Dil/ NOTE: Selecting the Cancel button in this dialog
Replace Dil/Sheath Sheath Filter task box will not log the task. Disables Analyzer
Filter dialog box. button. for Diluent/Sheath Filter replacement.
2. Select Close Filter
Valve button.
3. Open the Left Front
Cover.
Maintenance Activity 1. Select Open Filter Enables the Analyzer to Ready State, logs the
Completion Valve button. activity to the Maintenance Log and closes the
2. (Optional) Enter 6007 – Replace Dil/Sheath Filter dialog box.
comments in the <Enter
Comment:> field.
3. Select Log Task
Complete button to
indicate the task has
been performed.
NOTE: Selecting the
Cancel button in
this dialog box will
not log the task.
The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, Scheduled tab.
Replacement parts NA
Preparation in 6008 – Extended 1. Select Extended Auto-Clean NOTE: Selecting the Cancel
Auto-Clean dialog box. task button. button in this dialog box
will prompt for
2. Aliquot 2 mL Enzymatic
confirmation of request. If
Cleaner into empty tube.
the request is confirmed,
the system continues the
process to cancel the
operation. The system
logs the cancellation in
the event log.
Aspirate Enzymatic Cleaner and 1. Hold the tube up until the tip of When Auto-Clean cycle is
Begin Auto-Clean cycle. the open probe touches the complete, the system goes into
bottom of the tube and select Standby State.
the Start Extended Auto- NOTE: See Subsection: 7003 –
Clean button. Prime for the procedure
NOTE: Do not remove the tube to start the system from
until you hear an audible the Standby State.
beep. Aspiration will take
90 seconds.
2. (Optional) Enter comments in
the <Enter Comment:> field.
NOTE: Comments are
automatically saved to the
Maintenance log view
when Extended Auto-
Clean cycle is complete.
The Analyzer Status must be in the Ready State and in the Open or
Prerequisite
Closed Mode. Maintenance view, As-Needed tab.
Replacement parts NA
Preparation in 6051 – Clean Bar 1. Select Clean Bar Code NOTE: Selecting the Cancel
Code Reader Window dialog box Reader Window task button. button in this dialog box
will not log the task.
2. Select Disable Analyzer
Disables Analyzer for
button.
cleaning.
3. Remove the Processor Cover.
Maintenance Activity Completion 1. Select Enable Analyzer Enables the Analyzer to Ready
button. State, logs the activity to the
2. (Optional) Enter comments in Maintenance Log and closes the
the <Enter Comment:> field. 6051 – Clean Bar Code Reader
3. Select Log Task Complete Window dialog box.
button to indicate the task has
been performed.
NOTE: Selecting the Cancel
button in this dialog box
will not log the task.
The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, As-Needed tab.
Lint-free
pads or absorbent toweling
Tools/materials required 3/32”Allen wrench or Allen driver
Small needle-nose pliers or similar tool
Replacement parts See Appendix A: Parts and Accessories for list number.
Preparation in 6052 – 1. Select Clean or Replace NOTE: Selecting the Cancel button in this
Clean or Replace Open Open Mode Probe task dialog box will not log the task.
Mode Probe dialog box button. Disables Analyzer for Open Mode
Probe replacement.
2. Select Disable Analyzer
button.
Maintenance Activity 1. Select Enable Analyzer Enables the Analyzer to Ready State, logs the
Completion button. activity to the Maintenance Log and closes
2. (Optional) Enter the 6052 – Clean or Replace Open Mode
comments in the <Enter Probe dialog box.
Comment:> field.
3. Select Log Task
Complete button to
indicate the task has been
performed.
NOTE: Selecting the Cancel
button in this dialog
box will not log the
task.
If the Closed Mode Needle becomes bent or becomes clogged (and performing the
special protocol Flush Closed Needle does not remove the blockage), the needle
should be replaced.
NOTE: The needle consists of two separate needles joined together, one for
venting and one for aspiration.
The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, As-Needed tab.
Replacement parts See Appendix A: Parts and Accessories for list number.
Preparation in 6053 – 1. Select Clean or Replace NOTE: Selecting the Cancel button in this dialog
Clean or Replace Closed Mode Needle box will not log the task. Disables
Closed Mode Needle task button. Analyzer for Closed Mode Needle
dialog box replacement.
2. Select Disable Analyzer
button.
3. Remove the Processor
Cover.
Maintenance Activity 1. Select Enable Analyzer Enables the Analyzer to Ready State, logs the
Completion button. activity to the Maintenance Log and closes the
2. (Optional) Enter 6053 – Clean or Replace Closed Mode Needle
comments in the <Enter dialog box.
Comment:> field.
3. Select Log Task
Complete button to
indicate the task has
been performed.
NOTE: Selecting the
Cancel button in
this dialog box will
not log the task.
Syringes on the CELL-DYN Ruby System should be cleaned only as necessary one
at a time to ensure that each syringe is replaced in the correct position. Replace
each syringe after it is cleaned and then remove the next one to be cleaned.
The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite Maintenance view, As-Needed tab.
NOTE: Only remove and replace one syringe at a time.
Preparation in 6054 – 1. Select Clean or NOTE: Selecting the Cancel button in this dialog box
Clean or Replace Replace Syringe task will not log the task. Disables Analyzer for
Syringe dialog box button. Syringe replacement.
2. Select Disable
Analyzer button.
3. Open the Right Front
Cover, lift and remove
the Right Front Railing.
Remove and Clean 1. Verify Analyzer Status These three syringes snap into their mounting
Syringe: indicates Maintenance brackets.
Sample Injection State, locate the
Syringe, or HGB Lyse Sample Injection 1 Sample Injection
Syringe, or WBC Lyse Syringe, or HGB Lyse Syringe
Syringe, or WBC Lyse
5
Syringe 2 HGB Lyse Syringe
Syringe on the front 3 WBC Lyse Syringe
right flow panel.
4 Diluent/Sheath
NOTE: Only remove and Syringe
replace one
5 Mounting Brackets
syringe at a time.
2. Place one finger
behind the upper
portion of the barrel 1 2 3 4
and one finger behind
the lower portion of the
plunger. Gently pull
forward until the
syringe barrel snaps
free from the syringe
mounting bracket and
the double collar
attached to the bottom
of the plunger clears
the syringe drive fork
on the syringe drive
assembly.
NOTE: The flattened
edges of the glass 1 Flattened Edge
flange at the 2
2 Tube Fitting
bottom of the
syringe barrel 3 Sample Injection
align with the Syringe 3
bottom edge of 4 Double Collar
the syringe 5 Base 1
mounting bracket. 4
3. Using one hand to 5
grasp the fitting at the
top of the syringe and
an absorbent towel to
catch any excess
reagent, carefully turn
the syringe
counterclockwise to
release it from the
fitting.
(Continued from
previous page)
4. Note the liquid level of
reagent in the syringe
so that it can be refilled
after cleaning to the
same approximate
level.
5. Slowly dispense the WARNING: Point tip away from eyes.
reagent into
appropriate waste
container or sink.
NOTE: Do not pull the
plunger out of the
barrel. Do not
push or pull on
the plunger when
the syringe is dry,
as it may damage
the plunger.
6. If replacing the syringe
with a new syringe,
remove the collar from
the old syringe using a
7/64" allen wrench and
attach to the new
syringe plunger,
tightening with the
7/64" allen wrench.
7. Immerse the tip of the
syringe in the container
of DI Water and
aspirate the water into
the syringe until it is
full. Dispense the water
into appropriate waste
container or sink.
Repeat this step 5
times.
8. Refill the syringe with
appropriate reagent to
the level noted in
Step 4.
NOTE: Sample Injection
Syringe is filled
with Diluent/
Sheath reagent.
Maintenance Activity 1. Select Enable Enables the Analyzer to Ready State, logs the activity
Completion Analyzer button. to the Maintenance Log and closes the 6054 – Clean
2. (Optional) Enter or Replace Syringe dialog box.
comments (e.g.
indicate each syringe)
in the <Enter
Comment:> field.
3. Select Log Task
Complete button to
indicate the task has
been performed.
NOTE: Selecting the
Cancel button in
this dialog box will
not log the task.
The Analyzer Status can be in the Standby or Ready State and in either
Prerequisite
the Open or Closed Mode. Maintenance view, As-Needed tab.
Preparation in 6055 1. Select Clean Fan NOTE: Selecting the Cancel button in this dialog box will
– Clean Fan Filter Filter task button. not log the task. Disables Analyzer for cleaning.
dialog box. 2. Select Disable
Analyzer button.
Remove Fan Filter 1. When Analyzer (Optional) The Fan Filter may be cleaned using a vacuum
Frame and Clean Status indicates cleaner once it is removed from the fan filter frame.
Fan Filter Maintenance State,
snap off the plastic 1 Intake Fan - Right 1
Fan Filter Frame side
from the left or right
side panel.
2. Remove the Fan
Filter from the Fan
Filter Frame and
rinse under running 1 Intake Fan - Left
water. side
3. Blot the Fan Filter
dry.
4. Reinsert the Fan 1
Filter into the Fan
Filter Frame and
snap the frame back
in place on the side
panel.
Maintenance 1. Select Enable Enables the Analyzer to Ready State, logs the activity to
Activity Completion Analyzer button. the Maintenance Log and closes the 6055 – Clean Fan
2. (Optional) Enter Filter dialog box.
comments in the
<Enter Comment:>
field.
3. Select Log Task
Complete button to
indicate the task has
been performed.
NOTE: Selecting the
Cancel button
in this dialog
box will not log
the task.
Special Protocols
The following Special Protocol procedures are in this subsection:
• 7000 – To Standby
• 7001 – Initialize Analyzer
• 7002 – Disable/Enable Analyzer
• 7003 – Prime
• 7004 – Empty/Fill Optical Flow Cell
• 7005 – System Shutdown
• 7006 – Drain Accumulator
• 7007 – Empty/Fill Reagent Reservoir
• 7008 – Flush Closed Needle
• 7009 – Prepare for Shipping
WARNING: Potential Biohazard. Wear lab coats, protective eyewear,
and gloves and follow biosafety practices as specified in the OSHA
Bloodborne Pathogen Rule (29 CFR 1910.1030) or other equivalent
biosafety procedures.
7000 – To Standby
This automated special protocol is available for the operator to place the Analyzer
in the Standby State prior to executing System Shutdown that powers off the
system.
NOTE: When the instrument has been idle for four hours, it will automatically
enter the Standby State.
NOTE: The Analyzer goes from STANDBY to READY state in 7 to 13 minutes.
This protocol rinses and drains fluidics, reduces laser power, and opens pinch
valves. The solenoid valves are automatically opened periodically to prevent the
tubing from becoming pinched if the Analyzer is left in this state. When the
protocol is complete, the operator may proceed to System Shutdown special
protocol to power off the System.
Place Analyzer in 1. Select Maintenance view. NOTE: Selecting the Cancel button in
Standby State this dialog box will not log the
2. Select Special Protocols tab.
task.
3. Select To Standby task button to open
the To Standby dialog box.
Enables the Analyzer to Standby State,
4. (Optional) Enter comments in the
logs the activity to the Event Log and
<Enter Comment:> field.
closes the 7000 – To Standby dialog box.
5. Select To Standby button.
Bring the Analyzer 1. Select F12 – Prime. Enables the Analyzer to Ready State.
out of Standby 2. Select the Datalog view.
State 3. Verify that the background results are
within acceptable limits before running
controls or patient specimens.
NOTE: If the results are unacceptable,
troubleshoot accordingly (refer to
Section 10: Troubleshooting
and Diagnostics, Subsection:
Troubleshooting Tips and
Techniques.)
Initialize the 1. Select Maintenance view. NOTE: Selecting the Cancel button in
Analyzer to the this dialog box will not log the
2. Select Special Protocols tab.
Ready State task.
3. Select Initialize Analyzer task button to
open the Initialize Analyzer dialog box.
4. (Optional) Enter comments in the <Enter
Comment:> field.
5. Select Initialize Analyzer button.
6. Select F12 – Prime. Enables the Analyzer to Initialized State,
7. Select the Datalog view. logs the activity to the Event Log and
8. Verify that the background results are closes the 7001 – Initialize Analyzer
within acceptable limits before running dialog box.
controls or patient specimens. Enables the Analyzer to Ready State.
NOTE: If the results are unacceptable,
troubleshoot accordingly (refer to
Section 10: Troubleshooting and
Diagnostics, Subsection:
Troubleshooting Tips and
Techniques.)
Disable Analyzer 1. Select Maintenance view. NOTE: Selecting the Cancel button in
this dialog box will not log the
2. Select Special Protocols tab.
task.
3. Select Disable/Enable Analyzer task
button to open the Disable/Enable
Analyzer dialog box. Places Analyzer in Maintenance State
4. Select Disable Analyzer button. for maintenance task.
7003 – Prime
This automated special protocol is available for the operator to activate a System
prime, execute an auto background, and place the Analyzer in Ready State during
Analyzer power on, certain maintenance tasks, and corrective action for various
Analyzer fault conditions.
NOTE: During Analyzer power on, this same activity can be activated by
selecting the F12 – Prime button.
Prime the 1. Select Maintenance view. NOTE: Selecting the Cancel button in
Analyzer this dialog box will not log the
2. Select Special Protocols tab.
task.
3. Select Prime button to open the Prime
dialog box.
4. (Optional) Enter comments in the
<Enter Comment:> field.
5. Select Prime button.
6. Select the Datalog view. Enables the Analyzer to Ready State,
logs the activity to the Event Log and
7. Verify that the background results are
closes the 7003 – Prime dialog box.
within acceptable limits before running
controls or patient specimens.
NOTE: If the results are unacceptable,
troubleshoot accordingly (refer to
Section 10: Troubleshooting
and Diagnostics, Subsection:
Troubleshooting Tips and
Techniques.)
(Optional) Prime 1. Select F12 – Prime. NOTE: The F12 – Prime function key will
the Analyzer using only display when available.
2. Select the Datalog view.
the function key Enables the Analyzer to Ready State.
3. Verify that the background results are
within acceptable limits before running
controls or patient specimens.
NOTE: If the results are unacceptable,
troubleshoot accordingly (refer to
Section 10: Troubleshooting
and Diagnostics, Subsection:
Troubleshooting Tips and
Techniques.)
Empty Optical 1. Select Maintenance view. NOTE: Selecting the Cancel button in
Flow Cell this dialog box will not log the
2. Select Special Protocols tab.
task.
3. Select Empty/Fill Optical Flow Cell
task button to open the Empty/Fill
Optical Flow Cell dialog box. Analyzer Status indicates Maintenance
4. Select Empty Flow Cell button. State.
System Shutdown 1. Select Maintenance view. NOTE: Selecting the Cancel button in
this dialog box will not log the
2. Select Special Protocols tab.
task.
3. Select System Shutdown button to
open the System Shutdown dialog
box.
4. (Optional) Enter comments in the
<Enter Comment:> field. Opens dialog box to OK or Cancel
5. Select System Shutdown button. initiation of shutdown.
6. Select OK to initiate shutdown.
NOTE: The application and operating
system software will shutdown, the Logs the activity to the Event Log and
display will turn to black, and closes the 7005 – System Shutdown
instrument power will turn off. dialog box.
Drain Accumulator 1. Select Maintenance view. NOTE: Selecting the Cancel button in
this dialog box will not log the
2. Select Special Protocols tab.
task.
3. Select Drain Accumulator task button
to open the Drain Accumulator dialog
box.
4. (Optional) Enter comments in the
<Enter Comment:> field. Analyzer Status indicates Uninitialized
State, logs the activity to the Event Log
5. Select Drain Accumulator button.
and closes the 7006 – Drain
Accumulator dialog box.
NOTE: The system will automatically
initialize.
Empty Reagent 1. Remove reagent lines from reagent NOTE: Selecting the Cancel button in
Reservoir/Line containers. this dialog box will not log the
2. Select Maintenance view. task.
3. Select Special Protocols tab.
4. Select Empty/Fill Reagent Reservoir
task button to open the Empty/Fill
Reagent Reservoir dialog box.
5. Select either:
Empty WBC Lyse button Analyzer Status indicates Maintenance
Empty HGB Lyse button
State.
Empty Dil/Sheath button
Flush Closed 1. Select Maintenance view. NOTE: Selecting the Cancel button in
Needle 2. Select Special Protocols tab. this dialog box will not log the task.
3. Select Flush Closed Needle task
button to open the Flush Closed
Needle dialog box. Enables the Analyzer to Ready State,
4. (Optional) Enter comments in the logs the activity to the Event Log and
<Enter Comment:> field. closes the 7008 – Flush Closed Needle
5. Select Flush Closed Needle button. dialog box.
6. Run a whole blood before QC or Patient
testing.
Preparation • 3 Large beakers or NOTE: See Decontamination Procedures for the formula
containers. used to prepare this solution.
• Cleaning solution
(0.5% sodium
hypochlorite) 600 mL.
• DI water 300 mL.
• 200 mL of nonabrasive
detergent solution.
• Four Plastic Bags.
• Shear valve dummy
center section.
Prepare for 1. Remove the WBC NOTE: Selecting the Cancel button in this dialog box will not
Shipping with Lyse, HGB Lyse, and log the task.
0.5% sodium Diluent/Sheath reagent
hypochlorite lines from their reagent
containers and place
the lines in the
container with 300 mL
of cleaning solution.
2. Select Maintenance
view.
3. Select Special
Protocols tab.
4. Select Prepare for
Shipping task button
to open the Prepare
for Shipping dialog
box.
5. Select Prepare For Analyzer Status indicates Maintenance State.
Shipping button.
6. Continue with next
action.
Decontamination Procedures
The OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.1030) requires
decontamination of laboratory equipment prior to servicing or shipment:
• Flush the instrument by performing the 6001 – Auto-Clean cycle. This cycle
flushes all of the fluid pathways with reagents to purge any waste from the fluid
pathways. The Open Mode Probe and the Closed Needle are automatically
rinsed after every cycle. The surfaces of the instrument should be wiped with a
nonabrasive detergent solution to remove any soiling, then wiped with a
tuberculocidal disinfectant, such as a 0.5% sodium hypochlorite solution.
• If the instrument is to be shipped, it must be decontaminated prior to
shipment by performing the 7009 – Prepare for Shipping special protocol.
To calculate the percent (%) sodium hypochlorite concentration desired see the
following formula:
A = Percent (%) of sodium hypochlorite solution desired
B = Percent (%) of sodium hypochlorite stock solution (as purchased)
X = Parts of water to be mixed with one part of the sodium hypochlorite stock solution
B-A
X=
A
Example:
If you need a 0.5% solution of sodium hypochlorite for a cleaning procedure, and
the label on the bottle of bleach states that it is 5.25% sodium hypochlorite, then:
5.25 -.5
X= X = 9.5
.5
Add 9.5 parts deionized water to 1 part bleach to obtain a 0.5% sodium
hypochlorite solution, or 9.5 mL of deionized water to 1.0 mL of bleach (5.25%
sodium hypochlorite) to obtain 10.5 mL of a 0.5% solution of sodium hypochlorite.
Printer Cleaning
Printers must be turned off before cleaning. Do not dust inside the printer with
paper towels or tissues. Do not use solvents or strong detergents on the cabinets.
Printers should be cleaned as necessary to maintain good operating condition (at
least every six months or approximately every 300 hours of operation). For more
detailed maintenance instructions, refer to the printer manufacturer’s manual.
The CELL-DYN Ruby System utilizes liquid level sensing hardware to detect
when a reagent container is empty and requires replacement, as indicated by a
WBC Lyse Empty, HGB Lyse Empty, or Dil/Sheath Empty System Initiated
Message. See also Section 10: Troubleshooting and Diagnostics;
Subsection: List of System Messages.
The operator must first install a new container of reagent before selecting the Clear
Fault button in the SIM dialog box. A New Reagent Entry dialog box will open
that allows the operator to select which reagent is being replaced and record the
following:
• Lot Number
• Expiration Date
• Open Date
• % Remaining
• Comment
It is recommended to run at least five background counts to rinse the system and
verify that the background counts are within acceptable limits before running
controls or patient specimens.
NOTE: If the counts are unacceptable, troubleshoot accordingly (refer to
Section 10: Troubleshooting and Diagnostics, Subsection:
Troubleshooting Tips and Techniques.)
CAUTION: Do not pour the remaining contents of the old reagent
container into the new reagent container. This mixing could contaminate the
new reagent.
NOTE: The operator must enter the correct % Remaining or incorrect reagent
warning messages may occur.
The Analyzer must be Shutdown. Status must be in the Ready State and
Prerequisite
in the Open Mode. Maintenance view, Special Protocols tab.
Valve
Tubing (12”)
Tools/materials required
Hemostats (2)
Replacement parts NA
Preparation in 1. Select System NOTE: Selecting the Cancel button in this dialog box will not
7005 – Shutdown task button. log the task. Prepares the Data Module for shutdown
System and powers off the System.
2. Select System
Shutdown Shutdown button, the
dialog box. select OK.
The Open Sample Aspiration Probe is thoroughly cleaned whenever the Auto-
Clean cycle is performed. The probe may be cleaned manually using this procedure
if a blockage is suspected.
The Analyzer Status must be in the Ready State and in the Open Mode.
Prerequisite
Maintenance view, Special Protocols tab.
Replacement parts NA
Preparation in 7002 1. Select Disable/Enable NOTE: Selecting the Cancel button in this dialog box
– Disable/Enable Analyzer task button. will not log the task. Disables Analyzer for
Analyzer dialog cleaning.
2. Select Disable
box. Analyzer button.
3. Fill the syringe with NOTE: See Decontamination Procedures for the
Cleaning Solution. formula used to prepare this solution.
Run Auto-Clean
Daily
Inspect Syringes
9140553E—September 2013
Clean Shear Valve
Replace Dil/Sheath Filter
Decontamination Procedures
Printer Cleaning
Reagent Container Replacement
Non-
Replace Tubing in Normally
Scheduled
Closed (NC) Valves
Procedures
Unclogging Open Mode Probe
Calibration
Service and Maintenance Software
Service and Maintenance
9-75
† It is recommended that this scheduled maintenance activity be performed on a weekly basis if your laboratory is running the Reticulocyte assay.
Service and Maintenance
Service and Maintenance Software Section 9
NOTES
References
NOTES
Overview
This section provides the CELL-DYN Ruby operator with instructions for
identifying, troubleshooting and correcting instrument problems. The
Troubleshooting Guide is intended as a referral guide for customer troubleshooting
and optimal instrument operation and contains the following:
• Introduction to Troubleshooting
• Problem Categories
• Troubleshooting Procedures
• List of System Messages
• System Information Message Tables
The CELL-DYN Ruby continuously monitors the status of the system and displays
pertinent information in the Analyzer Status region. If a problem is detected, a
system message will display in the System Messages region.
NOTE: Generally, conditions that are instrument- or reagent-related will occur on
all samples, including controls. Therefore, if a problem is detected or
suspected, it is important to confirm instrument performance by re-
running controls.
WARNING: Potential Biohazard. Follow established biosafety practices
when performing maintenance, service or troubleshooting procedures.
Refer to Section 8: Hazards for additional information
If assistance is needed for any technical or operational problems, call your local
Country Service and Support Center.
When calling for assistance, be ready to provide the following information:
• Instrument model and serial number
• Software version
• Problem description
• Lot numbers and expiration dates of reagents, calibrator and controls
currently in use
• Maintenance procedures recently performed
• Troubleshooting steps taken
• Any data gathered in the course of troubleshooting
Introduction to Troubleshooting
Understanding normal instrument operation is essential for identifying and
resolving operational problems. Effective troubleshooting requires a logical, step-
by-step approach to problem solving. Logical troubleshooting can be divided into
three steps as follows:
1. Problem Identification—requires the Operator to investigate not only what
is wrong but also to note what is right. The investigation should identify the
problem area and eliminate areas that are working correctly. Once this step is
done, move to the next step.
2. Problem Isolation—further classifies an instrument problem. These
problems are generally divided into three categories:
– Measurement related to sample analysis
– Software related
– Hardware component related
Typically, hardware and software problems are Operator-correctable with
technical assistance. Measurement problems are generally Operator-
correctable and are further subdivided into problems related to sample
handling, maintenance, or calibration.
3. Corrective Action—involves taking appropriate steps to correct the
problem. If the Operator can correct the problem, with or without technical
assistance, normal operation can quickly resume.
Problem Categories
Problems encountered when running the CELL-DYN Ruby can be classified into
three categories:
• Observable problems
• Problems that generate System Messages:
– System Event Types
– System Information Messages (SIMs)
• Data-related problems
Observable Problems
Observable problems are easily noticed by the operator during routine operation or
maintenance. Examples of observable problems are salt deposits on the syringe
plunger or a flickering display.
System Messages
Problems or system events that generate System Messages are detected by the
System and lead to the display of message text in the System Messages region. The
System software determines which System Messages will be historically
documented to the System Event Log. Refer to Subsection: List of System
Messages for the complete list of System Messages and SIM numbers. See also
Section 9: Service and Maintenance, Subsection: Event Log.
The System Messages region will display up to seven messages at one time, with
the most recent appearing at the top of the region. When a system message appears
in the System Messages region, the operator can point and roll the mouse cursor
over the message line to display the full system message description information:
• Date and Time that the event occurred
• Sequence Number that the event occurred
• Type of system event:
– Information
– Warning
– Operator-Correctable Fault
– Sample Loader Fault
– Fatal Fault
• Description of the event
Information and Warning messages displayed in the System Messages region are
provided for informational purposes only and, based on their level of importance
for troubleshooting purposes, are documented to the System Event Log. They do
not have a System Information Message (SIM) dialog box associated with them.
Operator Correctable Fault (OCF), SL Fault, and Fatal Fault messages have an
associated SIM dialog box. Refer to Subsection: List of System Messages for the
complete list of System Messages and SIM numbers. See also Section 9: Service
and Maintenance, Subsection: Event Log.
If the Analyzer Status indicates Fatal Fault State, only the Save button is available
in SIM dialog box. It is important for the operator to review the recommended
corrective action described in the SIM dialog box before selecting the Save button
to remove the SIM dialog box from the view but save the message in the System
Messages region. The operator can point and roll the mouse cursor over the
message line to display the full system message description information or point
and click on the message line to re-open the SIM dialog box. Saving messages that
only contain a Save button causes the System to remain in a Fatal Fault State until
the situation is actually corrected.
Data-Related Problems
Data-related problems are noticed by the operator during review and analysis of
result data. This category includes problems that cause elevated backgrounds,
imprecision, or trends or shifts in control data.
NOTE: If the controls are out of range or if the instrument appears to be
inaccurate, follow your laboratory’s protocols to determine whether
calibration is required. If necessary, refer to Section 6: Calibration
Procedures for details.
Troubleshooting Procedures
The procedures in this section are for troubleshooting purposes only. A specific
procedure should be performed under one of the following conditions:
1. To correct a problem described in this section.
2. At the request of an Abbott Customer Service Specialist.
WARNING: Potential Biohazard. Follow established biosafety practices
when performing maintenance, service or troubleshooting procedures.
Refer to Section 8: Hazards for additional information.
To ensure that the new reagent is actually in the system, proceed as follows:
1. From Maintenance view, Special Protocols tab, select the Empty/Fill
Reagent Reservoir task button.
2. From the Empty/Fill Reagent Reservoir dialog box, select button for the
desired reagent and follow the instructions given on the screen.
3. Wipe the reagent line with a lint-free wipe before placing it in the new
container. Place the line in the container and secure the cap.
4. Select the button to refill the reservoir.
5. Run five Background counts before assessing the results.
NOTE: Verify background count results are within acceptable limits prior
to running controls or patient specimens.
1. Improper Sample Mixing 1. Verify all samples are well-mixed prior to analysis.
(Refer to Section 5: Operating Instructions,
Subsection: Routine System Startup.)
5. Worn Sample Transfer Pump Tubing 1. Inspect/Replace sample transfer pump tubing as
directed in Section 9: Service and
Maintenance, Subsection: Scheduled
Maintenance Procedures.
Three consecutive flow error messages (of the 1. Three consecutive flow errors of the same type
same type) occurred during Loader operation. will cause the Loader to halt. Refer to
Subsection: Troubleshooting a Flow Error
Message.
2. If unable to resolve this problem, contact
Abbott Customer Service.
The sensor system did not detect a sufficient 1. Check the specimen tube to be sure it contains a
amount of sample at the expected time sufficient quantity of sample. Verify that the
following aspiration. specimen contains no clots.
2. Clean the Open Mode Probe or the Closed
Mode Needle as directed in Section 9: Service
and Maintenance, Subsection: 6052 – Clean
or Replace Open Mode Probe or 6053 – Clean
or Replace Closed Mode Needle to remove any
obstructions.
3. Clean the Shear Valve as directed in Section 9:
Service and Maintenance, Subsection: 6006 –
Clean Shear Valve.
4. If unable to resolve this problem, contact
Abbott Customer Service.
The System in Closed Mode and the 1. Reinstall or reset the Processor cover. Make
Processor Tower Cover has been removed or sure the cover is held in position by the magnets
is not seated properly. on the instrument frame.
2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
A failure of the sensor or related electronics If unable to resolve this problem, contact Abbott
has occurred. Customer Service.
Specimen ID in the Pending Orders does not 1. Update the Test Selection in the Next Open
match the current test selection in the Next Tube Entry region to match the test selection in
Open Tube Entry region. the Pending Orders and process the specimen.
NOTE: When this action is complete, the
matched Pending Order will be removed.
2. (Optional) Process the specimen but do not
update the Test Selection in the Next Open
Entry region to match the test selection in the
Pending Orders.
NOTE: When this action is complete, the
demographic information for the Specimen ID
is transferred to the Next Open Tube Entry
(Detailed) window; however, the Specimen ID
record remains in Pending Orders.
Specimen ID in the Pending Orders does not 1. Update the Test Selection in the Next Open
match the current test selection in the Next Tube Entry region to match the test selection in
Open Tube Entry region. the Pending Orders and process the specimen.
NOTE: When this action is complete, the
matched Pending Order will be removed.
2. (Optional) Process the specimen but Do Not
update the Test Selection in the Next Open
Entry region to match the test selection in the
Pending Orders.
NOTE: When this action is complete, the
demographic information for the Specimen ID
is transferred to the Next Open Tube Entry
(Detailed) window; however, the Specimen ID
record remains in Pending Orders.
The data in the QCID file has violated one or Review the data in the QCID file and take
more of the enabled Westgard Rules selected appropriate action.
during set up of the QCID file.
The tube being processed is not tall enough. 1. Verify recommended collection tube
dimensions for use in closed mode. See
Section 7: Operational Precautions and
Limitations for recommended collection tube
dimensions for use in Loader Mode.
2. Reset the Racks.
3. Reset the Loader by pressing the following keys
in order; Clear Fault, Start Loader, Reset Loader.
A failure of the sensor or related electronics If unable to resolve this problem, contact Abbott
has occurred. Customer Service.
Three consecutive 0103 Sampling error – 1. Three consecutive 0103 Sampling error –
incomplete aspiration messages occurred incomplete aspiration messages will cause the
during Loader operation. Loader to halt. Refer to Subsection:
Troubleshooting the “Sampling error-
incomplete aspiration” Message.
2. If unable to resolve this problem, contact
Abbott Customer Service.
An increasing Retic Count rate was detected Rerun the Reticulocyte specimen.
in the optical flow cell during the Retic
measurement.
An air bubble. Run a background count to cycle air through the
system and rerun the Reticulocyte specimen.
If problem occurs repeatedly, refer to Subsection:
Troubleshooting a Flow Error Message
The Shear Valve did not rotate properly or in 1. Review the following recommended corrective
the allotted time. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance then Scheduled tab.
a. Perform Clean Shear Valve.
5. Select Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
6. If the message appears again, reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
Sensor or cable malfunction. If the problem occurs repeatedly, contact Abbott
Customer Service.
The Shear Valve did not rotate properly or in 1. Review the following recommended corrective
the allotted time and a blockage obstructs the action.
Diluent/Sheath reagent distribution through 2. Press the Save button to close the SIM dialog
the flow system. box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. Select Maintenance then Scheduled tab.
a. Perform Clean Shear Valve.
6. Select Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
Sensor or cable malfunction. If the problem occurs repeatedly, contact Abbott
Customer Service.
The tube in position 3 has liquid on it. 1. Remove the Processor Cover.
2. Dry the tube in position 3 and verify that it is not
leaking.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover, reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
The tube in position 3 either has a loose bar 1. If the bar code label is loose, secure it in place.
code label or too many bar code labels. If multiple bar code labels are on the tube,
remove them and carefully apply a single bar
code label.
NOTE: For information concerning proper
application of bar code labels, refer to
Section 4: Performance Characteristics and
Specifications, Subsection: Bar Code Label
Placement:.
2. Reset the racks, and reset the Loader by
pressing the following keys in order: Clear
Fault, Start Loader, Reset Loader.
The Mix Head Tube Grippers are dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with a 0.5%
sodium hypochlorite solution, clean the Mix
Head Tube Grippers. Refer to Section 9:
Service and Maintenance, Subsection: 6002 –
Clean Loader Components. (See the formula
for mixing this solution under Section 9:
Service and Maintenance, Subsection:
Decontamination Procedures.)
3. Repeat Step 2 with deionized water. Dry the
Mix Head thoroughly.
4. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the sensor or related electronics If the message appears repeatedly, contact Abbott
has occurred. Customer Service.
The tube in position 4 has liquid on it. 1. Remove the Processor Cover.
2. Dry the tube in position 4 and verify that it is not
leaking.
3. Reinstall the Processor Cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
The tube in position 4 either has a loose bar 1. If the bar code label is loose, secure it in place.
code label or too many bar code labels. If multiple bar code labels are on the tube,
remove them and carefully apply a single bar
code label.
NOTE: For information concerning proper
application of bar codes, refer to Section 4:
Performance Characteristics and
Specifications, Subsection: Bar Code Label
Placement:
2. Reset the racks, and reset the Loader by
pressing the following keys in order: Clear
Fault, Start Loader, Reset Loader.
The Mix Head Tube Grippers are dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with a 0.5%
sodium hypochlorite solution, clean the Mix
Head Tube Grippers. Refer to Section 9:
Service and Maintenance, Subsection: 6002 –
Clean Loader Components. (See the formula
for mixing this solution under Section 9:
Service and Maintenance, Subsection:
Decontamination Procedures.)
3. Repeat Step 2 with deionized water. Dry the
Mix Head thoroughly.
4. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
The tube in position 3 or 4 has liquid on it. 1. Remove the Processor Cover.
2. Dry the tubes in position 3 and 4, and verify that
they are not leaking.
3. Reinstall the Processor Cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
The Mix Head Tube Gripper is dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with a 0.5%
sodium hypochlorite solution, clean the Mix
Head Tube Grippers. Refer to Section 9:
Service and Maintenance, Subsection: 6002 –
Clean Loader Components. (See the formula
for mixing this solution under Section 9:
Service and Maintenance, Subsection:
Decontamination Procedures.)
3. Repeat Step 2 with deionized water. Dry the
Mix Head thoroughly.
4. Reinstall the Processor Cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
A failure of the sensor system or related 1. Remove the Processor Cover.
electronics has occurred. 2. Using a lint-free wipe moistened with lens
cleaner or deionized water, clean the tube
sensors. Dry the sensors thoroughly.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
The rack did not advance. 1. Check for an obstruction that is preventing the
rack from advancing and, if one is found,
remove it.
2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
The rack and/or Loader Tray are dirty. 1. Select Clear Fault.
2. Reset the racks before proceeding to the next
step.
3. Select Maintenance then Scheduled tab.
a. Perform Clean Loader Components.
4. Reset the Loader by pressing the following keys
in order: Start Loader, Reset Loader.
A failure of the Air Cylinder or a failure in the Contact Abbott Customer Service.
Air Cylinder pressure system has occurred.
The rack did not advance. 1. Check for an obstruction that is preventing the
rack from advancing and, if one is found,
remove it.
2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
The rack and/or Loader Tray are dirty. 1. Select Clear Fault.
2. Reset the racks before proceeding to the next
step.
3. Select Maintenance then Scheduled tab.
a. Perform Clean Loader Components.
4. Reset the Loader by pressing the following keys
in order: Start Loader, Reset Loader.
A failure of the Air Cylinder or the Air Contact Abbott Customer Service.
Cylinder pressure system has occurred.
Tube sensor in position 3 is dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with lens
cleaner or deionized water, clean the tube
sensors. Dry the sensors thoroughly.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the sensor system or related Contact Abbott Customer Service.
electronics has occurred.
The rack did not advance. 1. Check for an obstruction that is preventing the
rack from advancing and, if one is found,
remove it.
2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
The rack and/or Loader Tray are dirty. 1. Select Clear Fault.
2. Reset the racks before proceeding to the next
step.
3. Select Maintenance then Scheduled tab.
a. Perform Clean Loader Components.
4. Reset the Loader by pressing the following keys
in order: Start Loader, Reset Loader.
A failure of the Air Cylinder or the Air Contact Abbott Customer Service.
Cylinder pressure system has occurred.
Tube sensor in position 4 is dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with lens
cleaner or deionized water, clean the tube
sensors. Dry the sensors thoroughly.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the sensor system or related Contact Abbott Customer Service.
electronics has occurred.
A rack remains in the mix zone when the 1. Remove the rack from the mix zone.
Loader is reset. 2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
There is an obstruction at tube position 4 that 1. Remove the Processor Cover.
is activating the sensor. 2. Check for an obstruction at tube position 4 that
is activating the sensor and, if one is found,
remove it.
3. Reinstall the Processor Cover. Reset the racks.
Reset the Loader by pressing the following keys
in order: Clear Fault, Start Loader, Reset
Loader.
Tube sensor in position 4 is dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with lens
cleaner or deionized water, clean the tube
sensors. Dry the sensors thoroughly.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Reset Loader.
A failure of the sensor system or related Contact Abbott Customer Service.
electronics has occurred.
The System is functioning as intended. No corrective action is necessary. When you wish to
run additional samples in the Loader, load tubes in
racks and press the keys in the following order:
Clear Fault, Start Loader, Resume Loader.
The rack advance mechanism is not making 1. Check for an obstruction that is preventing the
contact with the racks. rack arms from extending and holding the racks
against the loader wall so the racks can engage
with the rack advance mechanism. If an
obstruction is found, remove it.
2. Reset the racks and reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Resume Loader.
Both tube sensors are dirty. 1. Remove the Processor Cover.
2. Using a lint-free wipe moistened with lens
cleaner or deionized water, clean the tube
sensors. Dry the sensors thoroughly.
NOTE: For the location of the tube sensors,
refer to the figure in Section 1: Use or
Function, Subsection: Sample Loader
Components.
3. Reinstall the Processor Cover, reset the racks,
and reset the Loader by pressing the following
keys in order: Clear Fault, Start Loader,
Resume Loader.
A failure of the sensor or related electronics, Contact Abbott Customer Service.
or loader mechanisms, has occurred.
One or more racks did not move properly in 1. Check for an obstruction that is preventing rack
the unload area. movement in the unload area and, if one is
found, remove it.
2. Reset the racks. Reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
A failure of the sensor system or related If the message appears repeatedly, contact Abbott
electronics has occurred. Customer Service.
The Shear Valve did not rotate properly or in 1. Review the following recommended corrective
the allotted time. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance then Scheduled tab.
a. Perform Clean Shear Valve.
5. Select Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
6. If the message appears again, reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
Sensor or cable malfunction. If the problem occurs repeatedly, contact Abbott
Customer Service.
WOC heater temperature is sensed as being 1. If using the Loader, reset the racks before
outside of the manufacturer’s specified range proceeding to the next step.
due to: 2. Reboot the system.
1. Ambient temperature below or above a. Select File, then Shutdown…
manufacturer’s specified range.
b. Select OK to initiate Shutdown.
2. Heater temperature sensor failure.
c. Wait 5-10 seconds after the display turns
3. Heater is stuck OFF (low temperature black, then press the Data Station power
failure) or ON (high temperature failure). button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
3. If the message appears repeatedly, contact
Abbott Customer Service.
HGB heater temperature is sensed as being 1. If using the Loader, reset the racks before
outside of the manufacturer’s specified range proceeding to the next step.
due to: 2. Run a background count and review results.
1. Heater temperature sensor failure. Background results must be within acceptable
2. Heater is stuck OFF (low temperature limits before running controls or Patient
failure) or ON (high temperature failure). Specimens.
3. If the message appears again, reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
4. If the message appears repeatedly, contact
Abbott Customer Service.
Hard drive Subsystem failure out of hard Contact Abbott Customer Service.
drive space.
Hard drive Subsystem failure out of hard Contact Abbott Customer Service.
drive space.
The instrument software was unable to 1. Review the following recommended corrective
initialize. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. If using the Loader, reset the racks before
proceeding to the next step.
b. Select File, then Shutdown…
c. Select OK to initiate Shutdown.
d. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.
The A32MAIN.S software file is missing 1. Review the following recommended corrective
after software installation or upgrade. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.
A failure in the Analyzer hardware, possibly Contact Abbott Customer Service.
related to the HSSL cable, card, or memory,
has occurred.
The allotted time for the flow sequence (Fsq) 1. Review the following recommended corrective
downloading was exceeded. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.
Computer hardware component failure or Contact Abbott Customer Service.
malfunction.
Unable to open High Speed Serial Link 1. Review the following recommended corrective
(HSSL) driver action.
2. Press the Save button, to close the SIM dialog
box.
3. Check the HSSL cable connections.
NOTE: For the location of the HSSL ports,
refer to Section 1: Use or Function,
Subsection: Data Module Components.
4. Reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.
Computer hardware component failure or Contact Abbott Customer Service.
malfunction.
Communication between Analyzer and Data 1. Review the following recommended corrective
Module failed. action.
2. Press the Save button to close the SIM dialog
box.
3. Check the HSSL cable connections.
NOTE: For the location of the HSSL ports,
refer to Section 1: Use or Function,
Subsection: Data Module Components.
4. Reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.
Computer hardware component failure or Contact Abbott Customer Service.
malfunction.
Flow script did not execute in expected time. 1. Review the following recommended corrective
action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
6. See Section 5: Operating Instructions,
Subsection: Power On and Power Off.
7. If the message appears repeatedly, contact
Abbott Customer Service.
Data Module and Analyzer did not 1. Review the following recommended corrective
communicate properly. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.
Communication between the Analyzer and 1. Review the following recommended corrective
the Data Module did not occur when action.
expected. 2. Press the Save button to close the SIM dialog
box.
3. Check the HSSL cable connections.
NOTE: For the location of the HSSL ports,
refer to Section 5: Operating Instructions,
Subsection: Power On and Power Off.
4. Reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.
During the initialization process, the Data 1. Review the following recommended corrective
Module and Analyzer did not communicate action.
properly. 2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.
An illegal software operation was requested 1. Review the following recommended corrective
by the Analyzer. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.
A failure in the Analyzer hardware has 1. Review the following recommended corrective
occurred. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.
A failure in the Analyzer hardware has 1. Review the following recommended corrective
occurred. action.
2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
5. If the message appears again, reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
6. If the message appears repeatedly, contact
Abbott Customer Service.
When the system was powered ON, the 1. Review the following recommended corrective
Analyzer did not transmit the correct message action.
to the Data Module. 2. Press the Save button to close the SIM dialog
box.
3. If using the Loader, reset the racks before
proceeding to the next step.
4. Reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.
A hardware failure or system error has 1. Review the following recommended corrective
occurred. action.
2. Press the Save button to close the SIM dialog
box.
3. Check the Hssl cable connections.
NOTE: For the location of the Hssl ports,
refer to Section 1: Use or Function,
Subsection: Data Module Components.
4. If using the Loader, reset the racks before
proceeding to the next step.
5. Select Maintenance, Special Protocols tab.
a. Perform Initialize Analyzer.
b. Perform Prime.
NOTE: Verify background count results
are within acceptable limits prior to running
controls or patient specimens.
6. If the message appears again, reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
7. If the message appears repeatedly, contact
Abbott Customer Service.
Communication timed out between Analyzer 1. Review the following recommended corrective
and Data Module. action.
2. Press the Save button to close the SIM dialog
box.
3. Check the HSSL cable connections.
NOTE: For the location of the HSSL ports,
refer to Section 1: Use or Function,
Subsection: Data Module Components.
4. Reboot the system.
a. Select File, then Shutdown…
b. Select OK to initiate Shutdown.
c. Wait 5-10 seconds after the display turns
black, then press the Data Station power
button to reboot the system.
NOTE: See Section 5: Operating
Instructions, Subsection: Power On and
Power Off.
5. If the message appears repeatedly, contact
Abbott Customer Service.
The window on the Bar Code Reader is dirty. 1. Review the following recommended corrective
action.
2. Reset the racks before proceeding to the next
step.
3. Press Clear Fault to close the SIM dialog box.
4. Select Maintenance then As-Needed tab.
a. Perform Clean Bar Code Reader.
b. Reset the Loader by pressing the following
keys in order: Start Loader, Reset Loader.
The tube position bar code label is scuffed or 1. Clean or replace the tube position bar code
dirty. label.
2. Reset the racks and reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
The rack from the mix zone was not removed Reset the racks, then reset the Loader by pressing
and reset before the Reset Loader key was the following keys in order: Clear Fault, Start
pressed. Loader, Reset Loader.
The Bar Code Reader cable has been If the message appears repeatedly, contact Abbott
disconnected, or the Bar Code Reader or Customer Service.
related electronics has failed.
The window on the Bar Code Reader is dirty. 1. Review the following recommended corrective
action.
2. Reset the racks before proceeding to the next
step.
3. Press Clear Fault.
4. Select Maintenance then As-Needed tab.
a. Perform Clean Bar Code Reader
Window.
b. Reset the Loader by pressing the following
keys in order: Start Loader, Reset Loader.
The tube position bar code label is scuffed or 1. Clean or replace the tube position bar code
dirty. label.
2. Reset the racks and reset the Loader by pressing
the following keys in order: Clear Fault, Start
Loader, Reset Loader.
The Bar Code Reader cable has been If the message appears repeatedly, contact Abbott
disconnected, or the Bar Code Reader or Customer Service.
related electronics has failed.
Invalid specimen ID in a record for which a 1. Ensure that specimen ID is valid. See section on
manual transmit was initiated. Valid Specimen ID.
A record for which a manual transmit was 1. Only one instance of a specimen ID is allowed
initiated is already queued for transmission. on the queue at a time. Check the cause for two
orders with the same specimen ID.
Overview
When to Run QC
The frequency of quality control runs should be determined by each laboratory.
This may be specified by the regulatory agencies governing the laboratory. Quality
Control specimens should be run and results confirmed to be within acceptable
limits prior to reporting patient results. Controls should also be run:
• After a reagent lot number change
• After maintenance, component replacement, or a field service action
• After a software change
• Following calibration
• According to your laboratory’s quality control program
• According to regulatory requirements
QC Methods
The following programs are for monitoring daily quality control using commercial
and whole blood patient controls:
• QCID File Data and Statistics
• Westgard Rules
• Levey-Jennings Graphs
The following program is available for System performance monitoring during
routine analysis of patient specimens:
Moving Average Programs (including X-B) and associated Levey-Jennings
Graphs
Control Material
Commercial controls contain fixed cells and are assayed by the manufacturer to
determine target ranges. Refer to Appendix A: Parts and Accessories for the list
of available commercial control material that can be used for monitoring the CBC
(including differential) and reticulocyte parameters. MCHC Flag will not trigger
on QC-Commercial Control type.
NOTE: Flags may occur with control materials and should be disregarded.
Whole Blood patient controls are fresh specimens selected from normal patients
and tested by the laboratory to establish target ranges. They are an accurate and
cost-effective means of evaluating the performance of the CELL-DYN Ruby.
NOTES
NOTES
Quality Control
QC View
This section discusses the QC View, which is selected from the tool bar. The QC
View stores all Quality Control ID (QCID) result data and the control
demographic information in a log format on the CELL-DYN Ruby. Their Datalog
view sequence number displays the QC run results chronologically when results
are available for each QCID specimen run. The QC run view that contains the
scatterplot and histogram details can be viewed either by using the mouse to
highlight and double click on the record or by selecting the F7 – View QC Spec.
See also Subsection: View QC Spec.
The options used to set up the QCID files are available from Setup, QCID Setup…
menu bar where the Operator can edit the lot number and expiration date for the
selected QCID files, enter means and range values for each parameter specified on
screen, and select which Westgard Rules will be applied to Quality Control results.
When reviewing QCID L-J Plots or QCID Data, using F6 – View QC Setup can
also access the QCID Setup information dialog box. Parameter results for any
control run that fall outside the entered limits are displayed in color (purple for out-
of- range high and yellow for out-of-range low) and underlined on the printout to
alert the Operator. See also Subsection: QCID File Setup.
Program Operation
QCID Files
QC result data and statistics are stored in QCID Files. Three QCID subtypes
available on the CELL-DYN Ruby are:
• Commercial
• Whole Blood
• Background and RETC_Background
NOTE: QC limits and control data information are not customizable for
QCID subtype Background and RETC_Background.
A QCID File is assigned to each level of
commercial control and each whole blood patient
control. There is a maximum of 500 QCID files
that can be set up and created on the System. The
QCID file data can also be downloaded to a floppy diskette for use with the
interlaboratory QC monitoring CELL-DYN eQC program that compares
instrument performance between different labs, allowing you to determine the
reliability of your laboratory testing. Refer to Subsection: Download QCID Data.
QCID file summary data currently stored in each file can be displayed and printed.
Each time a QC specimen is run, the number of specimens, mean, coefficient of
variation, and standard deviation for each parameter displayed are calculated and
updated automatically in each file. The Operator can, at any time, elect to reject any
run with flagged (outside entered limits) data from this calculation or move any
specimen run from one QCID file to another QCID file. Refer to Subsection:
Rejecting/Accepting Specimens and Subsection: Edit QC Specimens.
Westgard Rules status can be applied to the analysis of QCID specimen results with
Westgard Rule warnings viewable in the QCID file summary data on screen and
printed on reports. The Levey-Jennings graphs for QCID file results can be printed.
Refer to Subsection: Analyzing QCID File Results later in this section.
NOTES
Using QC View
Main QC View
Tab Views
The QC View consists of the following 7 tab views:
• CBC
• DIFF
• RBC
• PLT
• RETC
• DIFF ABS
• QC Info
The following column headings are
common to all 7 tab views:
• Seq# - Datalog sequence
number
• Spec ID – QCID Specimen ID number
• M - Mode: O = Open Mode or C = Closed Mode
• Date – Run date
Use the screen navigation keys to scroll (horizontally or vertically) through the
complete list of parameter tab views for all specimens displayed or use the mouse
and click on the tab to display a different parameter view.
Navigation
Function Keys
When QC View is selected from the tool bar the following function keys are
displayed for all tab views:
• F1—Print
• F2—Transmit
• F3—Find/Filter
• F4—Edit
• F5—Moving Average
• F7—View QC Spec
• F8—QC L-J Plots
Table 11.2 QC View — Function Keys
Displays the Run View for Tabs and Function keys will
F7—View QC the highlighted QCID record change in this view. See
Spec also Subsection: Moving
Average Programs.
QCID Deletion
QCID Deletion can be used to delete QC Whole Blood or QC Commercial QCIDs.
Deletion can be done from the QC View screen.
Or you can select Delete QC log records for QCID (the one high-lighted and all
other records for that QCID.
After a QCID has been deleted (either QC Whole Blood or QC Commercial), the
data log displays:
• Specimen ID: “Deleted_QCID”
• Original Specimen ID: <blank>
• Draw Date: <blank>
• Draw Time: <blank>
• Lot Number: <blank>
• Expiration Date: <blank>
• Parameter set: “1”
Data in fields other than those noted are unaffected by the QCID deletion.
View QC Spec
Chartable tab Lab tab Graphs tab
Selecting the F7–View QC Spec function key from the QC View displays three
tabs — Chartable, Lab, Graphs — which reveal the specimen information for the
selected record. The following function keys are displayed.
Table 11.3 Function Keys — View QC Spec
When F8–QC L-J Plots is selected from QC View to display the QCID file Levey-
Jennings view for the highlighted QCID record, the following function keys are
displayed in all tab views.
Table 11.4 Function Keys — QCID File Levey-Jennings View
QCID Data
When F8—QCID Data is selected from QCID L-J Plot view to display the QCID
View (QCID file data) for the highlighted QCID record, the following function
keys are displayed for all tab views.
QCID Deletion
QCID Deletion can be used to delete QC Whole Blood or QC Commercial QCIDs.
Or you can select Delete QC Log records for QCID (the one high-lighted and all
other records for that QCID).
After a QCID has been deleted (either QC Whole Blood or QC Commercial), the
data log displays:
• Specimen ID: “Deleted_QCID”
• Original Specimen ID: <blank>
• Draw Date: <blank>
• Draw Time: <blank>
• Lot Number: <blank>
• Expiration Date: <blank>
• Parameter set: “1”
Data in fields other than those noted are unaffected by the QCID deletion.
F5—Download QCID Data can be selected from either the QCID L-J Plot or the
QCID Data view to display the Download QCID Data dialog box.
Field Description
Buttons Description
View QC Setup
Control Data page
QC Limits page
Westgard page
F6—View QC Setup can be selected from either the QCID L-J Plot or the QCID
Data view to display the QCID Setup: View dialog box. The QCID Setup: View
has three tabs:
• Control Data
• QC Limits
• Westgard
Each dialog box and the qualities specific to the dialog box are explained in each
section. The buttons which are common to each dialog box are explained in QC
Setup Buttons.
Control Data
Control Data page, Control Type: Background
The Control Data information which is displayed is based on the control type for
the selected QCID file.
Table 11.8 Fields — QCID Setup: View, Control Data Dialog Box
Field Description
QCID Select the name using the pull-down menu
Control Data Indicates the type of control: Commercial, Whole Blood,
Information Background
Comments Optional operator entered comments in QCID file Setup
Field Description
Westgard
A multi-rule system applied to the data in each of the QC Files to detect drift and
imprecision and to detect systematic or random error.
Field Description
Rule Westgard
Description
# Term
QC Setup Buttons
Table 11.11 Buttons — QCID Setup: View, Control Data Dialog Box
Buttons Description
Edit
Table 11.11 Buttons — QCID Setup: View, Control Data Dialog Box (Continued)
Buttons Description
Edit
Table 11.11 Buttons — QCID Setup: View, Control Data Dialog Box (Continued)
Buttons Description
QC Limits page,
QCID:
Background
Moving Average
View, X-B page
displaying Levey-
Jennings graphs
When F8-Levey Jennings is selected from the Moving Average View, the
following function keys are available from all tabs.
Table 11.13 Function Keys-Levey Jennings View
When F6-Selected Batch Data is selected from the Levey Jennings View, the
following function keys are available from all tabs.
Table 11.14 Function Keys-Selected Batch Data View
From the Selected Batch Data View, users can select and view:
• Current Batch Data
• Closed Batches
Commercial
Field Description
Buttons Description
2. Select Create and the QCID Setup: Basics dialog box opens.
Field Description
Buttons Description
3. Enter the new Quality Control ID or scan the bar code (if one is present) in
the New QCID field.
NOTE: If entering the QCID using a keyboard, ensure that the first
character is a tilda, “~”.
NOTE: Ensure that CAPS Lock on the keyboard is OFF when using the
Hand-Held Bar Code Reader.
4. Select the control type from the pull-down menu in the control field.
5. To access the QC assay values, go to the www.abbottdiagnostics.com.
Contact your Country Service and Support Center for detail.
A. To upload control assay values from website:
a. From lab computer, format the USB flash memory by clicking on Start
(lower left of computer screen), and selecting Programs, Accessories,
Windows Explorer, Computer, then right click on the drive containing
the USB flash memory and select Format. The screen will appear as
below. Make sure the format settings for “File system” are selected as
identified below.
NOTE: FAT is equivalent to FAT16
Table 11.19 Field — QCID Setup: Create New, Control Data Dialog Box
Field Description
Control Type Indicates the type of control selected in the Basics dialog
box: Commercial
Test Section Type of test selected from pull-down menu: CBC + NOC
or RETIC
Control Brand Select from the pull-down menu, N/A or select a product
Level Select from the pull-down menu, one of the following: I, II,
III, Low, High, Normal
Table 11.20 Buttons — QCID Setup: Create New, Control Data Dialog Box
Buttons Description
a. If assay values were uploaded from a disk use the control assay sheet to
confirm the values displayed on the screen are correct for the appropriate
level.
Remove the disk and store it in a safe location. Discard the disk when the
lot has expired.
b. If an assay disk was not used, enter the control assay values using the
control assay sheet.
NOTE: If a mean/limit combination is entered that causes the lower limit to be
less than zero, the lower limit will be automatically set to zero in the QC
limits tab and the QC data view.
The QCID L-J Plots will display the actual range entered.
.
Table 11.21 Field — QCID Setup: Create New, QC Limits Dialog Box
Field Description
Table 11.22 Buttons — QCID Setup: Create New, QC Limits Dialog Box
Buttons Description
Table 11.23 Field — Means and Limits [+/-] Update Details Dialog Box
Field Description
Buttons Description
b. Insert the floppy disk into the drive. If not using a floppy disk select
Cancel.
c. The Browse for Folder window appears. Select the target location and
click Open.
d. Select the file to upload.
e. Select Open to close the Browser.
f. Proceed to the next step.
NOTE: At the bottom of the dialog box: ! Means and/or limits (+/-) have
been updated.
7. Confirm that the assay values displayed on screen are correct for the
appropriate level.
8. Remove media and store it in a safe place in case it is needed to reload data
for this control lot.
Table 11.25 Field — QCID Setup: Create New, Westgard Dialog Box
Field Description
Rule Westgard
Description
# Term
Table 11.26 Buttons — QCID Setup: Create New, Westgard Dialog Box
Buttons Description
9. Select the Rule or Rules, if any, and click OK. The QCID Setup: View
dialog box opens, reflecting the newly created QCID information.
Whole Blood
Field Description
Test Selection Type of test to be run, selected from the pull-down menu
Buttons Description
2. Select Create and the QCID Setup: Basics dialog box opens.
Field Description
Buttons Description
3. Enter a name, or scan the bar code, if one is present, in the New QCID field
and select Whole Blood from the pull-down menu in the Control Type field.
4. Select Continue and the QCID Setup: Create New dialog box appears.
NOTE: The new QCID and Control Type are listed.
Field Description
Draw Date/Time Enter the date and time of the blood draw. Select the
check box to activate the field and enter the
information. To set the dates and time do one of the
following:
Type the information in
Use the pull-down menu to set the information
Test Selection Select the type of test from the pull-down menu:
CBC,CBC+NOC, etc.
Table 11.32 Field — QCID Setup: Create New, QC Limits Dialog Box
Field Description
6. Select Update Mean/Limits (+/-) and the Update Details dialog box opens.
Table 11.33 Field — Means and Limits [+/-] Update Details Dialog Box
Field Description
Buttons Description
Table 11.35 Field — QCID Setup: Create New, Westgard Dialog Box
Field Description
Rule Westgard
Description
# Term
Table 11.36 Buttons — QCID Setup: Create New, Westgard Dialog Box
Buttons Description
9. Select the Rule or Rules, if any, and click OK. The QCID Setup: View
dialog box opens, reflecting the newly created QCID information.
3. Select Delete.
After a QCID has been deleted (either QC Whole Blood or QC Commercial), the
data log displays:
• Specimen ID: “Deleted_QCID”
• Original Specimen ID: <blank>
• Draw Date: <blank>
• Draw Time: <blank>
• Lot Number: <blank>
• Expiration Date: <blank>
• Parameter set: “1”
Data in fields other than those noted are unaffected by the QCID deletion.
QC Download ID Setup
The QC Download ID File Setup information is used to enter Laboratory
Identification information for the QCID file. This information is necessary for
participants in the CELL-DYN eQC Program. Laboratory Identification must be
entered before QC data can be transferred to the floppy disk.
Field Description
Country Country
Field Description
Buttons Description
Field Description
Buttons Description
2. Select or deselect the Monitor Moving Average On/Off checkbox for each
tab view.
3. Select OK to save the changes, and the dialog box closes.
Field Description
Table 11.41 Field — Customized Moving Average View Dialog Box (Continued)
Field Description
Add Heading
Remove Heading
Buttons Description
Performing a QC Run
Always mix and handle commercial control materials according to the directions
given on the package insert. Proper mixing is essential for accurate results.
Rejecting/Accepting Specimens
Specimens can be rejected or accepted as needed. For example, one or more runs
can contain results that you do not wish to use in determining the QCID file mean.
1. To reject a QC specimen, proceed as follows:
2. From the QC View, highlight the specimen record from the log.
3. Select F8 – QCID L-J Plots, then select F8 – QCID Data.
4. From the QCID data view, highlight the specimen record and select F5 –
Reject to reject the specimen record from the QCID file data statistics. The
checkmark next to the rejected record will be removed. Rejecting a specimen
record does not remove the record from QCID file.
NOTE: Selecting F5 – Accept will include the specimen record in the
QCID file data statistics.
Edit QC Specimens
QC specimen runs can be edited to move from one QCID file to another. (For
example, if the Operator ran the incorrect level of control for the QC Specimen ID
selected in the Open Mode.) The QC specimen run can be moved to the correct
QCID file.
When moving one QCID file to another, the QCID file records must have the same
test selection and be of the same QCID type (i.e., Whole Blood, Commercial).
2. Select F8 – QCID L-J Plots and the Levey-Jennings format is displayed for
the selected specimen.
4. From the QCID data view, highlight the specimen record and select F4 – Edit
to open the QCID Edit dialog box.
5. Select the new QCID from the drop down list, enter an (optional) comment
in the Comment field, and select the OK button to close the dialog box.
2. The QCID Edit dialog box displays. From the Change to QCID dropdown
list, select the new QCID, and then click OK.
3. The QC - QCID View dialog box displays. The highlighted row(s) display
with their QCID number (in the Spec Id column).
The QC Status region and the System Messages region show the general status of
quality control programs and can provide an early indication of potential problems.
If one or more of the Westgard Rules has been violated, a warning message is
displayed in the System Messages region and the Rule Alert field in the QC
Status region will indicate Yes. Moving Average Program monitoring can be
turned on or off as desired. If one or more of the closed batch data sets for each
Moving Average Program is out-of-limit, the Moving Average Program will
indicate OUT next to the program parameter title in the QC Status region. The
Operator should investigate to determine whether any intervention or corrective
action is needed.
If there is a problem, the operator should attempt to attribute the cause to the
control material, procedural error, reagents, or System operation. The operator can
do the following:
Review all information in the QCID File(s) involved
• Open the QCID Setup dialog box for the QCID File(s) and check that the
means and limits are within acceptable limits according to the package insert
or the laboratory’s historical ranges
• Review the Reagent, Maintenance, and System Logs to see if reagent
changes, maintenance procedures, or other events could be the cause or could
have contributed to the problem
• Review the Moving Average Programs and Datalog to see if the patient
samples exhibit a similar shift or trend
• Review the Calibration Log for records of recent calibration and any specific
comments and remarks
• Examine the System setup settings to ensure that the operating conditions and
setups are correct
For additional guidance in isolating problems with data, refer to Section 10:
Troubleshooting and Diagnostics.
Levey-Jennings Graphs
Levey-Jennings graphs are a visual method of viewing quality control result data
for all parameters over time. These graphs allow the Operator to examine the
relationship of control result values to the established means and acceptable limits,
and to look for shifts and trends in results. All specimens in the QCID file will be
graphed. There are six customizable parameter tabs on the Levey-Jennings view.
The graph label will include the parameter being graphed and Westgard Rule
warnings for that parameter. Scale values on the left side of the graph indicate:
• Solid black line is the mean
• Dotted orange line is the ±2SD
upper and lower limits
• Solid red line is the ±3SD upper
and lower limits
CAUTION: QC limits are assumed to be at ±2SD for Westgard Rule
analysis and for Levey-Jennings graphs. It is crucial to ascertain that the QC
file range entered in the QCID Setup, QC Limits tab represents 2SD for
the laboratory for each parameter before interpreting Levey-Jennings
graphs and Westgard Rules.
Values in the QCID file which are outside of the graph range will appear above the
solid red line.
NOTE: Results from rejected specimens will not appear on the graph.
When a rule is selected (turned ON), a plus sign is displayed to the right of the
parameter. A minus sign is displayed if a rule is not selected (turned OFF). Rule
violations for a parameter are recorded above the Levey-Jennings graph for that
parameter. Whenever a rule is violated, the number of the rule will be displayed to
the right of the parameter in place of the plus sign.
CAUTION: QC limits are assumed to be at ±2SD for Westgard Rule
analysis and for Levey-Jennings graphs. It is crucial to ascertain that the QC
file range entered in the QCID Setup, QC Limits tab view represents the
laboratory’s ± 2SD range for each parameter before interpreting Levey-
Jennings graphs and Westgard Rules.
The rule violations listed above the graphs represent the modified Westgard Rule
status of the most recent control sample processed.
CAUTION: Do not use the values for mean range provided on the control
assay sheet in conjunction with Westgard Rules. Before using Westgard
Rule with commercial controls, establish the SD for each parameter on your
instrument and update QC limits based on these SDs.
Rule Violations
Only the directly measured parameters need to be monitored with multiple rules.4
In Laboratory Quality Management, Cembrowski and Carey suggest a protocol for
using the Westgard Rules in hematology. The following is a synopsis of that
protocol.
Because all three levels of control are typically used to monitor a hematology
analyzer, it is reasonable to consider all three at the same time. In other words,
check for rule violations across the three levels, not just within a particular level. If
the same rule is violated for more than one level, determine whether the violation
indicates a loss of precision or a loss of accuracy and troubleshoot accordingly.
Cembrowski suggests that the results for all three levels first be checked to see if
they are within their 2SD limits. If all three levels meet this criterion, the
instrument is in control.
If any control result exceeds the 2SD limits, check to see if it exceeds the 3SD
limits. If a result exceeds 3SD, there are two possibilities. There is either an
instrument problem or a problem with one particular level of control. Therefore, if
a result exceeds 3SD, run another vial of that control. If the problem persists, then
additional investigation is required.
Check to see if the 2 of 3 sub 2S or R sub 4S rules have been violated for any level
or across levels. If the problem is confined to one level of control, check for a 2 sub
2S rule violation for that level. Again, if the violations are confined to one level of
control, use another vial and possibly another lot. Verify and follow all storage,
mixing, and handling instructions provided in the control package insert. Check
expiration dates and data entry. Check to be sure that the control is run into the
correct file, and the means and limits have been entered correctly for the particular
lot number in use.
If a combination of rules has been violated across three levels, determine whether
the violations indicate a loss of precision or a loss of accuracy, and troubleshoot
accordingly. Do not process patient specimens. If necessary, contact your Country
Service and Support Center.
When the problem has been resolved, Cembrowski suggests that all levels be run
again in duplicate to confirm that the problem has in fact been corrected.
Overview
The Moving Average programs on the CELL-DYN Ruby automatically and
continuously monitor instrument performance. This allows identification of
potential problems and more efficient troubleshooting. The programs track the
results of various parameters in the patient population analyzed on the System. On
the CELL-DYN Ruby, the Moving Average Programs and their associated
parameters and measurements include the following:
• X-B Program: MCV, MCH, MCHC
• WBC Program: WBC, %N, %L, %M, %E, %B and population statistics
(mean) for neutrophils and lymphocytes
• RBC/PLT Program: RBC, RDW, HGB, HCT, MCH, MCHC, MCV, PLT, and
population statistics (mean) for linear RBC, PLT, and RBC
• RETC Program: %R and population statistics (mean) for RETC
Any combination of Moving Average Programs can be active. The settings for each
Moving Average Program can be controlled independently of the other Moving
Average Programs.
Population statistics are also used by Abbott field personnel to evaluate fluidics or
other system problems, and are explained in Subsection: Principles of Moving
Average Analysis within this section.
A study5 by Dr. Bull collected data from 1767 patients and yielded the following
mean values for the red cell indices:
MCV = 89.9 fL
MCH = 30.5 pg
MCHC = 33.9 g/dL
These values confirmed other data that Dr. Bull published in an earlier study6 and
are used in the CELL-DYN Ruby as the default target values for beginning X-B
analysis.
The default action limit for the red cell indices is set at 3%.
Each laboratory should confirm the default values and, if necessary, establish its
own target values for the RBC indices. The action limits can be set to 5% during
the study period and tightened to 3% when the target values are confirmed. Refer
to Subsection: Establishing the Target Value immediately following.
A suggested protocol and guidelines for interpreting data based on X-B analysis
can be found in Chapter 1 of Laboratory Hematology, An Account of Laboratory
Techniques, edited by I. Chanarin.7
1. Collect data from at least 400 patients. (The 1.5% is one-half the allowable +
3% action limit.) If the CVs are greater than 1.5%, an additional 400 samples
should be evaluated.
2. If the CVs calculated in step 1 are less than 1.5%, enter the mean as the
Confirmed Target Value.
X-B is is is is is is Index
Pattern increased decreased increased decreased increased decreased Derivation
Collect data from 20 batches of 20 specimens each for a total of 400 specimens.
Data collection should be from specimens which represent the typical specimen
population that is processed through the instrument. When all 20 batches are
complete, print the Moving Average Program WBC tab view. Refer to
Subsection: Printing Moving Average Programs Information. Calculate the
mean, standard deviation (SD), and coefficient of variation (CV) for each
parameter. The CV for LYM 0, LYM 10, NEU 0, and NEU 10 should be
<2.5%. The CV for NEU 90, NEU 90 depolarized, and NEU-EOS should be
<5%. If the CV for each index meets these criteria, enter the calculated mean value
as the target value and set the action limits to 5% for LYM 0, LYM 10 NEU 0,
and NEU 10, and to 10% for NEU 90, NEU 90 depolarized, and NEU-EOS.
NOTE: Laboratories analyzing specialized patient populations (as described
above) may need to widen the action limits slightly to accommodate
results from these abnormal patients.
If the CV for each index is more than the limits described above, evaluate another
400 specimens and repeat the calculations.
When an acceptable target value has been entered, evaluate data from an additional
400 specimens to confirm the entered values.
Acceptance
Parameter Target Value Action Limit
Limits
NOTES
References
NOTES
Overview
The Reticulocyte Package software enables the operator of the CELL-DYN Ruby
System to analyze a whole blood specimen for reticulocytes. The Reticulocyte
specimen is prepared by the operator using reticulocyte reagent to produce a
diluted, stained sample. Reticulocyte specimens can be run as batches, or they can
be run on a STAT basis.
The Reticulocyte Package is enabled by selecting the Retic test selection in the
Next Open Tube Entry (NOTE) region and acknowledging the message to run the
reticulocyte method startup script. Reticulocyte processing and specimen
demographic orders can be added to the CELL-DYN Ruby manually or
automatically via the Laboratory Information System (LIS). See Section 5:
Operating Instructions, Subsection: Pending Orders in Open Mode. The
Reticulocyte Package is disabled by selecting either of the test selections: CBC,
CBC + NOC, CBC + RRBC in the Next Open Tube Entry (NOTE) region and
acknowledging the message to run the reticulocyte method cleanup script.
NOTE: The cleanup script takes approximately three minutes to return the
Analyzer Status to Ready state.
When the prepared reticulocyte specimen is run on the CELL-DYN Ruby, results
are measured as reticulocyte percent (%R). The reticulocyte absolute value
(RETC) is automatically calculated when the RBC concentration is entered using
the F12 – RBC Source function key.
Reticulocyte results are stored chronologically in the Datalog view. Reticulocyte
Quality Control ID (QCID) File Setup, control material processing in the Open
Mode, control results analysis and file data management, Westgard rules, Levey-
Jennings graphs, and Moving Average Programs can all be displayed in QC View.
For more information on the Datalog view and QC View see Section 5: Operating
Instructions, Post-Analysis Processing – Datalog View and Section 11: Quality
Control.
This section contains the following subsections:
– Principles of Operation
– Setup Guidelines
– Retic Test Selection
– Enabling Reticulocyte Processing
– Disabling Reticulocyte Processing
• Routine Operation
– Reticulocyte Specimens
• Quality Control
• Maintenance and Troubleshooting
NOTES
Principles of Operation
RUN VIEW
When the reticulocyte results fall outside patient limit sets, the result is displayed
in color on the screen to alert the operator. Results displayed in yellow are below
the limit, results displayed in purple are above the limit, and these flagged results
are underlined on the printed report. Patient results that exceed the linearity
specifications will be suppressed and (>>>>) will be displayed and printed.
Setup Guidelines
NOTES
Routine Operation
Overview
This section contains information and procedures that are recommended for the
routine operation of the Reticulocyte Package for the CELL-DYN Ruby System.
This section contains the following subsections:
• Reticulocyte Specimens
• Specimen Requirements
• Interfering Substances
• Running Specimens
– RETC_Background Counts
– Quality Control
– Specimen Preparation
– Patient Specimens
Reticulocyte Specimens
This subsection discusses routine operation of the Reticulocyte Package.
Guidelines and procedures are provided for running RETC_Background counts,
quality control, and patient specimens. Proper start-up procedures should be
performed prior to processing patient specimens. The Reticulocyte Package is only
available for use in the Open Mode.
For RETC_Background counts a tube of reticulocyte reagent is run without an
aliquot of whole blood to check for particulate material in the reagent and system.
RETC_Background counts should be performed, at a minimum, each day that
reticulocyte specimens are run or as required according to the laboratory’s protocol
and with each new lot of reagent.
Always mix and handle commercial control materials according to the directions
given on the package insert. Proper mixing is essential for accurate results. Patient
reticulocyte controls should be run and handled according to the laboratory’s
protocol. Quality control checks should be performed, at a minimum, each day that
reticulocyte specimens are run or as required according to the laboratory’s protocol.
The operator enters the reticulocyte specimen ID to be run (Patient, QCID, or
RETC_Background) into the Specimen ID QCID field of the Next Open Tube
Entry (NOTE) region. If the specimen ID is matched to a record in the Orders
view, the System will display there is a match and the specimen demographics from
the pending order will be used in the Next Open Tube Entry (Detailed) dialog
box. See the following graphic example. When the reticulocyte sample is
completed and the Analyzer Status indicates Ready, the operator can then enter a
new specimen ID for the next specimen to run. Specific instructions for each
specimen type are given later in this section.
Specimen Requirements
A fresh non-hemolyzed, whole blood specimen collection in K2EDTA is the
specimen of choice for Reticulocyte analysis on the CELL-DYN Ruby System.
Specimens may be run up to 8 hours after collection time when stored at room
temperature.
NOTE: Studies have shown that reticulocytes continue to mature at room
temperature. Increased flagging can occur when using specimens more
than 8 hours old.
If a delay in analysis is anticipated, specimens may be processed up to 72 hours if
stored at refrigerated temperature.
Refrigerated samples must be brought to room temperature before mixing; this
avoids damaging any fragile cells.
For the Absolute Reticulocyte calculation, it is recommended that the RBC
concentration used must be selected from the same specimen that will be used for
the Reticulocyte count and preferably run on the same analyzer.
When the F11 - RBC Source key is used to locate the RBC count, the system alerts
the operator when a valid result is not found. If a specimen is more than 8 hours old
and the CBC was processed more than 8 hours prior to performing the Reticulocyte
analysis, manual entry of the RBC value is an option. The System will alert the
Operator if the manual entry of the RBC value exceeds the software limit. See the
following two graphic examples. If the RBC value is not entered, only the %R
value will be obtained.
Interfering Substances
The CELL-DYN Ruby Reticulocyte method is a nucleic acid staining method.
Therefore, other substances that contain nucleic acids could potentially be
enumerated by the instrument as reticulocytes. If these interfering substances are
present in sufficient numbers, they may interfere with the dynamic thresholds used
to obtain the CELL-DYN Ruby reticulocyte count. Consequently, these specimens
should be flagged by the instrument. Refer to Subsection: Maintenance and
Troubleshooting, Operational Messages and Data Flagging within this chapter
for a complete description of the Reticulocyte flags.
The information in the following table, based on CLSI Document H44-A21,
indicates substances that are known or potential interference. The
CELL-DYN Ruby Reticulocyte procedure is designed to minimize some common
interference, including high WBC counts and NRBC.
Table 12.1 Known or Potential Interferences
Specimen Preparation
CAUTION: When using the reticulocyte reagent, avoid contact with skin
and clothing. This reagent contains New Methylene Blue, which will stain
skin, clothing, and many other surfaces.
Running Specimens
RETC_Background Counts
The reticulocyte background (RETC_Background) count should be included in the
daily start-up procedures to check for particulate matter in the reticulocyte reagent
and the CELL-DYN Ruby System. The RETC_Background count is determined
from the total counts that occur in the reticulocyte scatter area on the 10°/90°
scatterplot.
NOTE: Confirm that the RETC_Backgound count is within acceptable limits
before running controls or patient specimens.
7. Remove the tube when the beep sounds. The Wash Block will move down the
probe and clean it.
8. When the cycle is complete, the Wash Block moves back to the top of the
probe and the Ready state will display in the Analyzer Status region.
9. The Run View and Datalog, RETC tab view displays the
RETC_Background (RBGD) count results.
10. Verify that the RETC_Background count is within the acceptable limit of less
than or equal to 100 counts.
NOTE: Results that are outside the acceptable range are displayed in
purple.
11. If the RETC_Background count is unacceptable, repeat it. If the repeated
count is still unacceptable, follow the directions for troubleshooting
RETC_Background count problems given in Subsection: Maintenance and
Troubleshooting later in this section.
Quality Control
Quality control checks should be performed, at a minimum, each day that
reticulocyte specimens are run or as required according to the laboratory’s
protocol. Always mix and handle commercial control materials according to the
directions given in the package insert. Proper mixing is essential for accurate
results. Patient reticulocyte controls should be run and handled according to the
laboratory’s protocol. See Section 11: Quality Control, Subsection: QCID File
Setup, for details on customizing the Quality Control ID (QCID) files.
8. Open the well-mixed, prepared control specimen tube and immerse the Open
Probe in the sample.
9. Press the Touch Plate located behind the probe to start the cycle. The BUSY
indicator light on the Analyzer Status Indicator Panel will be illuminated in
yellow. The Analyzer Status region will display messages indicating the
various stages of the cycle.
10. Remove the tube when the beep sounds. The Wash Block moves down the
probe and cleans it.
11. When the cycle is completed, the Wash Block moves back to the top of the
probe. Wait for the Ready state to display in the Analyzer Status region.
12. Repeat steps 7 through 11 for all prepared control specimens.
13. Verify that the control results are acceptable.
NOTE: Out-of-range results are displayed in color. Data invalidating alerts,
such as Fragile RBC, are not valid when running commercial
controls.
14. If the results are unacceptable, repeat the run. If the results are still
unacceptable, run the other levels of the control material. If the results are
still unacceptable, prepare another stained dilution of that level of the control
material. If the results on all levels are unacceptable, troubleshoot
accordingly. See Subsection: Maintenance and Troubleshooting.
15. When the control results are acceptable, patient samples may be analyzed.
Patient Specimens
A fresh non-hemolyzed, whole blood specimen collection in K2EDTA is the
specimen of choice for Reticulocyte analysis on the CELL-DYN Ruby System.
Specimens may be run up to 8 hours after collection time when stored at room
temperature.
NOTES
The CELL-DYN Ruby System offers several quality control options to monitor
and validate instrument performance while running the Reticulocyte Package. The
options are:
• QCID Files Quality Control ID (QCID) file statistical and
graphical analysis of the data in each file to
calculate the mean, standard deviation, and
coefficient of variation
• Westgard Rules A multi-rule system applied to the data in
each of the QC files
• Moving Average Programs Monitors population statistics to detect
changes in the System’s optical measurement
process
Each of these options is discussed in detail in Section 11: Quality Control.
All QC data should be reviewed according to your laboratory’s protocol.
Control Material
See Appendix A: Parts and Accessories for the list of available controls for use
on the CELL-DYN Ruby. These controls should be run:
• After daily start-up procedures are completed
• After a reagent lot number change
• After maintenance, component replacement, or a field service action
• After a software change
• Following calibration
• According to your laboratory’s quality control program
• According to regulatory requirements
NOTE: Data invalidating alerts, such as Fragile RBC or ERL, are not valid
when running commercial controls.
Reagent
• Use Reticulocyte Reagent manufactured only by Abbott Laboratories. Verify
the expiration date.
• Store the Reticulocyte Reagent in the dark at room temperature.
• Use one Reticulocyte Reagent tube for each CELL-DYN control or patient
specimen.
NOTES
Overview
This section provides instructions for identifying, troubleshooting, and correcting
instrument system information messages and conditions in the Reticulocyte
Package. These instrument conditions may be found in Section 10:
Troubleshooting and Diagnostics.
This section is divided into the following subsections:
• Maintenance
• General Guidelines for Reticulocyte Troubleshooting
• Operational Messages and Data Flagging
• Dispersional Data Alerts
• Instrument Alert Messages
• Instrument Alert Messages with Suppressed Reticulocyte Results
• Data Invalidating Alerts
• High RETC_Background Counts
NOTE: For a list of interfering substances, refer to Subsection: Interfering
Substances.
Maintenance
A list of scheduled and nonscheduled maintenance procedures can be found in
Section 9: Service and Maintenance, Subsection: Recommended Service
and Maintenance Schedule.
It is recommended that the scheduled maintenance activity 6008 – Extended Auto-
Clean be performed on a weekly basis when a laboratory is running the
Reticulocyte Assay.
Excessive RBC Loss (ERL) • Specimen staining time 1 Prepare another dilution verifying proper
too long in the specimen preparation as discussed in
reticulocyte reagent Subsection: Specimen Preparation,
• Rapid degeneration of and run after adequate incubation as
RBC indicated in the Reagent package insert.
• High concentration of 2 Rerun the specimen.
platelets, platelet 3 If the flag persists, verify the reticulocyte
aggregates, or other results by an alternative method.
interfering substances
• Microcytic RBC
• Improper instrument
settings
Too Few Events • Inadequate whole blood Prepare another dilution verifying proper
Alert occurs when fewer than sample mixing specimen preparation as discussed in
3000 events are counted – Improper pipetting Subsection: Specimen Preparation within
during the Reticulocyte count – Blood not stained this chapter.
cycle. • Cold Agglutinin Verify Reticulocyte results by an alternate
method.
References
NOTES
List numbers are unique identifiers that are used when ordering products. The list
number and quantity provided in Appendix: A Parts and Accessories are intended
for guidance only and are subject to change. Contact your Abbott representative for
the most current information regarding list numbers.
Table A.1 CELL-DYN Ruby Hardware List Numbers
08H07-02 1 Printer, Graphics (color laser with 220 VAC (Sourced locally)
USB port connector)
08H60-05 1 OKI B4600 220V Printer Mono Laser Printer (220V, Sourced
locally)
Part/List
Quantity Name Description
Number
03H96-01 1 pkg Ring, Pull Solenoids Ring for Pulling Solenoid Valves
3106545* 1 Tubing (120" roll) Tygon Tubing (1/4" ID, 3/8" OD)
92376-01 1 pkg Tubing set, Transfer Pump Package of one Transfer Pump
Tubing Assembly
Part/List
Quantity Name Description
Number
07H67-02 5 Cap (large), Reagent line tubing For the 3.8 and 20L containers
99650-01 1 Labels, Tube ID Bar Code, 1 roll Tube ID Bar Code Labels (1000
labels per roll)
06H62-01 1 Labels, CELL-DYN Rack Bar Bar Code Labels for Sample Loader
Code, set of 100 Racks (#s 0-99)
91485-01 1pkg Tubing Set, Transfer Pump Package of four (4) Transfer Pump
Tubing Assemblies
Table A.5 CELL-DYN Calibrator and Controls for use on CELL-DYN Ruby
08H57-01 1 kit Calibrator, CELL-DYN HemCal 2, 3-mL tubes with pierceable cap,
Plus insert, and assay sheets
08H58-01 1 kit Control, CELL-DYN 29 Plus (with 12, 3-mL tubes (4 tubes each of low,
Retic), full-pack (tri-level) normal, and high control) with
pierceable caps, insert, and assay
sheets
08H58-02 1 kit Control, CELL-DYN 29 Plus 6, 3-mL tubes (2 tubes each of low,
(with Retic), half-pack (tri-level) normal, and high control) with
pierceable caps, insert, and assay
sheets
08H59-01 1 kit CELL-DYN 26 Plus Tri-Level 12, 2.5 mL tubes, insert, and assay
Control sheet
08H59-02 1 kit CELL-DYN 26 Plus HALF-PACK 6, 2.5 mL tubes, insert, and assay
Tri-Level Control sheet
08H62-01 1 kit Control, Retic Plus 3.0-mL tubes, levels I and II,
pierceable caps, insert, and assay
sheet
Case Weight
List Number Quantity Name Single Container Size
QTY/ Case
NOTES
Appendix B – Reference
Table B.1 Potential Causes of Spurious Results with Automated Cell Counters (Continued)
Mean Cell High white cell count (> 50,000/µL) Spuriously low hemoglobin
Hemoglobin Spuriously high hemoglobin Spuriously high red cell count
Spuriously low red cell count
SOURCE:
• Cornbleet, J. “Spurious Results from Automated Hematology Cell Counters.” Laboratory Medicine, 1983.
August 14: 509-514.
Index
A B
Access Rights 2-9, 2-45, 2-46, 2-47 Background
Analysis Counts, on demand 5-16
Closed Mode 5-31 High Retic 12-28
Enzymatic Cleaner 9-30 RETC_Background 12-15
Open Mode 5-30 Troubleshooting 10-5
Specimen Analysis Tasks 5-13 Backup
Task 5-11 Configure 5-40
Analyzer 1-7 Media 5-40
Analyzer failed to prime 10-16, 10-78 Bar Code
Anticoagulants 4-5, 7-6 characters 4-8
Recommended 4-5 codes: Code 39, Code 128, CODABAR,
As-Needed Service and Maintenance 9-4 Interleaved 2 of 5, and ISBT
Aspiration 1-15, 8-12 formats 1-12
Bar Code 5-17 ID 5-15, 5-22
cleaning 9-34, 9-37, 9-59, 9-71 match 5-22
Closed 3-1, 5-13 match by bar code label specimen ID 5-19
disposal 8-12 part numbers A-3
Enzymatic Cleaner 9-16, 9-30 Pending Orders 5-20
Incomplete 5-34, 10-7, 10-11, 10-17 placement 5-18, 5-31, 9-17
Normal Volume 4-5 reader 1-6, 1-12, 1-22, 1-23, 1-28
Open 3-1, 5-13 setup 2-9, 2-42, 2-57
Open Tube Mode Aspiration Probe Specimen Identification 1-5, 4-8, 5-18
(Open Mode Probe) 1-9 Bar Code Labels See also Bar Codes
Open Tube Mode Aspiration Probe Placement 4-9
(with Wash Block) 1-12, 8-12 Bar Code Reader Window 9-32
Sample 3-1, 6-1 cleaning 9-32
Sampling error 5-34, 10-7 dialog box 6051 9-33
Tower 10-40, 10-48, 10-49, 10-77 Bar Code Symbol Dimensions & Label
Vent needles 8-12 Requirements 4-7
Aspiration Volume Specification 4-5 Bar Codes See also Bar Code Labels
Assistance, Telephone i, 10-1 Symbologies
ATYPDEP 2-9, 2-66, 3-36 Codabar 4-7
Auto Background counts 5-8, 5-15, 7-3, 9-16, Code 128 4-7
10-5 Code 39 4-7
Auto-Calibration Wizard 5-22, 6-22 Interleaved 2 of 5 4-7
Autoloader Bar Codes See also Bar Code Labels
Specimen tube dimensions 7-6, 10-20 Symbologies
Automatic Backup 5-40 Codabar 4-8
Code 128 4-8
Code 39 4-8
P Q
Parameter Set 2-7, 2-25, 2-26 QC Limits 2-8, 11-30
Parts and Accessories A-1, B-1 edit 11-31
Patent Statement ii Setup 11-29
Patient Test Selection 5-21 tab 11-43
Pending Orders QC View 1-36, 2-8, 11-10, 11-13, 11-22,
Closed Mode 5-18 11-23, 11-64
Open Mode 5-24 Bar and Buttons 11-16
originating from 5-22 column headings 11-14
Performance Specifications 4-11 Customize 2-30
Peristaltic Pump vi, 1-14, 9-15 customize 12-7
Sample transfer 1-14, 8-11 Editing a QC specimen run 11-65
Tubing 9-20, 9-21 Function keys 11-16, 11-20, 11-22, 11-35
Wheel 9-20 Main 11-14
Permission 2-9, 2-45 Moving average 11-35, 12-1
Editing rights 2-46 Operator ID 5-15
Laboratory I and II 2-38, 2-39 QC Data 11-59
PLT 1-15, 1-16 QC Info tab 11-15
PLT calculation 3-22 QCID L-J Plots 11-22
PLT Messages 3-40 Tab views 11-14
Power View QC Spec 11-17
Off 5-6 QC Views 11-9
On 5-3, 9-69 QCID 11-18, 11-25
Specifications 4-3 QCID Files
Preparation for Shipment 8-8, 9-60 Deleting 11-18, 11-25
Preparing and Handling Controls 7-4 Moving QCID Specimen Runs 11-67
Preparing and Handling Specimens 7-6 Quality Control Guide 12-21
Preparing to run specimens 5-14 Quality Control Methods 11-3, 12-21
Prime 9-7 Quality Control Specimens 11-3, 12-23
Prime finished 10-11 Quick Precision Check 6-18
Priming 5-3, 5-8, 9-60
2099 Analyzer failed to prime 10-78 R
analyzer 9-54, 10-3, 10-16
fatal fault 10-3 Rack and Tube position 5-27
Prime finished - auto bkg to follow 10-11 Rack and Tube Setup 2-9, 2-59, 2-60, 5-18,
Printing 5-22, 5-23, 5-24, 5-26, 5-27, 10-25
Summary report of Pending Orders 5-20 RBC 1-15
Procedure RBC Count 3-20
Background Count 12-16 RBC Messages 3-39
Quality Control 12-17 RBC/PLT Analysis 3-6
RDW calculation 3-21
Reagent 7-4, 8-7
Reagent Heaters
HGB 1-15
WOC 1-15, 3-4
Specimen T
Handling 7-6
Specimen ID Validation 2-64 Technical Assistance i
Specimen Identification 7-4 Telephone Support i
Invalid 4-8, 5-18, 5-19 Temperature Specification 4-4
No ID 5-19 Throughput Specifications 4-5
Specimen Preparation 12-15, 12-18 Trademark Statements v
Specimen Requirements 12-11, 12-12 Transfer Pump 9-64
Specimen tube dimensions 7-6 Tubing 9-20
Specimen Tube, Minimum Volume in 4-6 Troubleshooting 10-1
Specimens, preparing and handling 7-6 tube dimensions 10-20
Analysis 5-1, 5-8, 5-13 Tube
collection 5-17 Tube Racks and Related Components 4-6
handling 5-14, 7-6 Tubes
mixing 5-18 Sample Loader 1-5
preparing 7-6 Tube Dimensions 4-5
preparing to run 5-14, 12-11 Tube Racks and Related Components 7-6
requirements 5-16 Tubes Dimensions 7-6
task 5-13 troubleshooting 10-40
Specimens, running Tubes Sensor Assembly 1-12
ID methods 5-19
rack and tube 2-59 U
Spill Clean-Up 8-7
Spinner Assembly 1-12 Ultrasonic Sensor 3-1
Standby procedure Unpacking and Inspection Guidelines 2-4
manually 9-7
Status conditions 3-27 V
Suspect Parameter Flags 3-32 Viewing Archived Data 5-46
Population 3-32 Views
Symbologies, Bar Code 4-7, 4-8 Datalog 1-35, 1-42, 2-8, 2-30
Syringes - HGB Lyse 1-16 Maintenance 9-6
Syringes - Sample Metering 1-16 Orders 5-20
Syringes - WBC Lyse 1-16 QC View 1-36, 1-42, 2-8, 11-9, 11-13
System Reagents 9-12
Backup features 5-40 Run 5-31
System Connection and Start Up Guidelines 2-5 System 9-9
System Information Messages, SIMS 10-4, Volumes
10-17 Minimum Volume in Specimen Tube 4-6
System Messages 10-3, 10-11 Nominal Aspiration Volume 4-5
System Priming 5-8
System Relocation and Shipping Guidelines 8-8
System View
Calibration Log 9-9
Event Log 9-10
Set Point Log 9-11