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Instructions for Use

UniCel® DxH 800


Coulter® Cellular Analysis
System

Hematology Specimen Processing


Module with System Manager

800
xHsis System
el D
UnultiC
Analy
llar
er Ce
Co

629743AE
March 2009
Beckman Coulter, Inc.
4300 N. Harbor Blvd.
Fullerton, CA 92835
UniCel® DxH 800 Coulter® Cellular Analysis System
Instructions for Use

PN 629743AE (March 2009)

Find us on the World Wide Web at: www.beckmancoulter.com

Beckman Coulter Ireland, Inc.


Mervue Business Park, Mervue Galway, Ireland 353 91 774068
Revision History

Initial Issue, 11/2008


Software Version 1.0
Issue AB, 12/2008
Software Version 1.0
Issue AC, 12/2008
Software Version 1.0.2.0
Issue AD, 03/2009
Software Version 1.1
Links to the changes are listed below:
• Updated Configure Reagents section, 9-4.
• Added Database Recovery Procedure, 10-32.
• Updated Daily Checks screen to include System Events, 3-5.
• Updated the heading for Clean the Pneumatic Supply Module Fan Filter, 12-13.
• Updated Figure 1.3, 1-5.
• Added references to Diluent 1 and 2 and Waste 1 and 2, 1-15.
• Updated the measurements for the Single-tube station with cradle, 1-9.
• Updated Single-Tube Presentation procedure, 5-17.
• Updated the Replace the Front Blood Detector procedure, 13-18.
• Updated the Exception Messages, 6-50.
• Updated the XB Batch Details instructions, 4-27.
• Updated Reporting Units, 9-67.
• Added EMC Information, 10-4.
• Updated Figure 9.38, 9-44.
• Updated Daily Shutdown, 8-2.
• Updated Input and Consumption on 1-28 and in Figure 1.3, Figure 1.4, and Figure 10.1.
• Added Using the Handheld Scanner to the Sample Analysis chapter.
• Updated Figure 6.15, Additional Data - CBC Screen.
• Added Range Error to the System Messages.
• Updated the path for Set Timeout Settings (Menu > Setup > Operators and Roles > Timeout Settings).
• Updated the description of Event Messages from the System Manager with Action Required.
• Added Clean the Handheld Bar-Code Scanner to Chapter 12.
• Added PPE Warnings to Cleaning procedures on 12-5, 12-10, 12-13, 12-16, 12-21, 12-23, 12-26, and 12-27.
• Added PPE Warnings to Replacement procedures on 13-3, 13-10, 13-19, 13-27, 13-33, and 13-36.
• Updated Table 1.22 and section heading to Closed and Open Vial Performance Characteristics.
• Added figure titles to Figures 1.7, 1.8, 5.3, 6.23, 6.24 and updated Figure 9.85 and Figure 11.8.
• Changed the Maximum Sound Pressure (Audible Noise) section to Acoustic Noise Level.
• Updated the call out list for Figure 2.5, Light Scatter on the DxH 800.
• Updated Figures 3.1, 3.2, 3.3, and 3.4 and pages 3-4 and 3-6 in the Daily Checks chapter.
• Added an explanation of the Edit System Recommendations button on 11-5 and 11-6.
• Added Biohazard warnings on 12-10,12-13, 12-16, 12-21, 12-23, 12-26, 12-27, 13-3, 13-10, and 13-27.
• Updated Clean the Handheld Bar-Code Scanner and corrected typos universally.

629743AE iii
Revision History

• Deleted the New Manual Entry (Other) section from the Setup chapter on 9-89.
• Updated Clean the Handheld Bar-Code Scanner.
• Deleted Replace the Hamilton Syringe from Replacement Procedures.
• Updated Table B.11.
• Updated Table 6.1, Figure 9.3 and Figure 10.3.
Issue AE, 03/2009
Software Version 1.1
Note: Changes that are part of the most recent revision are indicated by a bar in the left margin of the amended
page. Links to the changes are listed below:
• Updated the Revision History.
• Updated Figure 11.5.
• Updated step 5 of the Calibrate with COULTER S-CAL Calibrator procedure.

This document applies to the latest software listed and higher versions. When a subsequent software version affects the
information in this document, a new issue will be released to the Beckman Coulter Web site. For labeling updates, go to
www.beckmancoulter.com and download the latest version of the manual or system help for your instrument.

iv 629743AE
Safety Notice
Read all product manuals and consult with Beckman Coulter-trained personnel before attempting
to operate instrument. Do not attempt to perform any procedure before carefully reading all
instructions. Always follow product labeling and manufacturer’s recommendations. If in doubt as
to how to proceed in any situation, contact your Beckman Coulter representative.

Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards
such as the use of barrier protection. This may include, but is not limited to, protective eyewear,
gloves, and suitable laboratory attire when operating or maintaining this or any other automated
laboratory analyzer.

Alerts for Warning and Caution

Throughout this manual, you will see the appearance of these alerts for Warning and Caution
conditions:

WARNING
WARNING indicates a potentially hazardous situation, which, if not avoided, could
result in death or serious injury. May be used to indicate the possibility of
erroneous data that could result in an incorrect diagnosis.

CAUTION
CAUTION indicates a potentially hazardous situation, which, if not avoided, may
result in minor or moderate injury. It may also be used to alert against unsafe
practices. May be used to indicate the possibility of erroneous data that could
result in an incorrect diagnosis.

629743AE v
Safety Notice
Safety Precautions

Safety Precautions

WARNING
Risk of operator injury if:
• All doors covers and panels are not closed and secured in place prior to and
during instrument operation.
• The integrity of safety interlocks and sensors is compromised.
• Instrument alarms and error messages are not acknowledged and acted upon.
• You contact moving parts.
• You mishandle broken parts.
• Doors, covers and panels are not opened, closed, removed and/or replaced
with care.
• Improper tools are used for troubleshooting.

To avoid injury:
• Keep doors, covers and panels closed and secured in place while the
instrument is in use.
• Take full advantage of the safety features of the instrument.
• Acknowledge and act upon instrument alarms and error messages.
• Keep away from moving parts.
• Report any broken parts to your Beckman Coulter Representative.
• Open/remove and close/replace doors, covers and panels with care.
• Use the proper tools when troubleshooting.

CAUTION
System integrity could be compromised and operational failures could occur if:
• This equipment is used in a manner other than specified. Operate the
instrument as instructed in the product manuals.
• You introduce software that is not authorized by Beckman Coulter into your
computer. Only operate your system’s software with software authorized by
Beckman Coulter.
• You install software that is not an original copyrighted version. Only use
software that is an original copyrighted version to prevent virus
contamination.

CAUTION
If you purchased this product from anyone other than Beckman Coulter or an
authorized Beckman Coulter distributor, and, it is not presently under a Beckman
Coulter service maintenance agreement, Beckman Coulter cannot guarantee that
the product is fitted with the most current mandatory engineering revisions or
that you will receive the most current information bulletins concerning the
product. If you purchased this product from a third party and would like further
information concerning this topic, call your Beckman Coulter Representative.

vi 629743AE
Contents

Revision History, iii

Safety Notice, v

INTRODUCTION, xxxi

CHAPTER 1: System Overview, 1-1


Intended Use, 1-1
Parameters, 1-2
UniCel DxH 800 SYSTEM, 1-3
Hardware, 1-4
Overview, 1-4
Inter-Unit Connections, 1-4
Front View of the SPM, 1-7
Functional Modules, 1-7
Specimen Transport Module, 1-8
Input Buffer, 1-9
Single-tube Station with Cradle, 1-9
Pending Buffer, 1-9
Mix Station and Aspiration Probe, 1-9
Output Buffer, 1-10
Sample Aspiration Module, 1-10
Aspiration Syringe, 1-10
Blood Detectors, 1-10
BSV, 1-10
Aspiration Probe, 1-10
Bar-code Reader, 1-11
VCSn Module, 1-11
CBC Module, 1-11
Common Services, 1-11
Pneumatic Supply Module (PSM), 1-12
Optional Floor Stand, 1-12
System Manager Indicators, 1-17
Home Screen, 1-18
Global Menu Button, 1-19
Global Icons and Navigation/Status Buttons, 1-21

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Contents

Previous/Next Icons, 1-21


Single-Tube Presentation Icon, 1-21
Status Area, 1-21
Status Bar, 1-22
Alert Status Icons, 1-22
Utility Icons, 1-23
System Icons, 1-24
Local Navigation Bar, 1-24
Consumables and Supplies, 1-25
Recommended Reagents, 1-25
Material Safety Data Sheets (MSDS), 1-26
Recommended Controls and Calibrators, 1-26
Cassettes, 1-27
Physical Specifications, 1-28
SPM Temperature and Humidity Specifications, 1-28
Temperature, 1-28
Humidity, 1-28
Power, 1-28
Input, 1-28
Consumption, 1-28
Installation Category, 1-29
Pollution Degree, 1-29
Acoustic Noise Level, 1-29
Dimensions (Depth, Width, Height) and Weight, 1-29
Space and Accessibility Requirements, 1-30
Software Specifications, 1-31
Performance Specifications and Characteristics, 1-32
Anticoagulant, 1-32
Aspiration, 1-32
DxH 800 Sample Preparation, 1-32
Accuracy, 1-33
NRBC, 1-35
Body Fluids, 1-35
Repeatability, 1-36
Measuring and Operating Ranges, 1-37
Carryover, 1-39
Background Counts, 1-40
Throughput, 1-40
Reference Range Studies, 1-41
Body Fluids Reference Ranges, 1-44
Sample Stability and Storage, 1-45
Overview, 1-45
Clinical Sensitivity and Specificity Performance Characteristics, 1-47
Specimen Tubes, 1-47
Venous and Capillary Sample Performance Characteristics, 1-48
Closed and Open Vial Performance Characteristics, 1-49
Whole Blood and Pre-Dilute Performance Characteristics, 1-50
Limitations, 1-51

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Contents

CHAPTER 2: Operation Principles, 2-1


History, 2-1
Coulter Principle, 2-1
Coulter Method, 2-2
VCS Technology, 2-2
TTM, 2-3
Reticulocyte Analysis, 2-3
DxH 800 Operation Principles, 2-4
CBC Analysis, 2-4
Specimen Preparation, 2-4
Detection/Sensing, 2-5
Hemoglobinometry, 2-7
Generation of Histograms, 2-7
VCSn, 2-8
Sample Preparation, 2-8
Detection/Sensing, 2-8
MTM, 2-8
Volume and Conductivity, 2-9
Measuring Light Scatter and Axial Light Loss, 2-9
Dataplot Development, 2-11
Two-Dimensional (2-D) Dataplots, 2-12
Three-Dimensional (3-D) Dataplots, 2-12
Surface Plots, 2-13
Parameter Measurement, Derivation, and Calculation, 2-14
Quality Control Principles, 2-17
Overview, 2-17
Daily Checks, 2-17
Commercial Controls, 2-17
Extended QC, 2-17
XB Analysis, 2-17
XM, 2-18
IQAP, 2-18

CHAPTER 3: Daily Checks, 3-1


Daily Checks (Menu > QA > Daily Checks), 3-1
Setup, 3-1
Log on to the System Manager, 3-1
Run Daily Checks, 3-2
Daily Checks Screen , 3-3
DIFF, RETIC, and NRBC , 3-5
Export Daily Checks, 3-7
Review Daily Checks, 3-7
Print Daily Checks, 3-8

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Contents

CHAPTER 4: Quality Control, 4-1


Overview, 4-1
When a Commercial Control is Outside its Expected Range, 4-2
When a COULTER LATRON CP-X Control is Outside its Expected
Range, 4-2
Setup Controls, 4-2
Analyze Commercial Controls, 4-3
Viewing Control Files - Data View (Menu > QA > QC), 4-3
Options on the Local Navigation Bar on the Quality Control
Screen, 4-6
Select a Control, 4-7
View Control Files Graphically (Menu > QA > QC > View Graph), 4-8
Thumbnail Levey-Jennings Graph, 4-9
Expanded Levey-Jennings Graph, 4-9
View Logs, 4-10
View Details of a Control Run, 4-11
View Additional Data, 4-14
Add, Modify, or Delete Comments, 4-15
Filter the View, 4-16
Delete Control File Records, 4-18
Transmit Control Files , 4-19
View Control Files Under Error Conditions, 4-20
Export Quality Control Data (Menu > QA > QC > More Options >
Export), 4-21
Reports, 4-22
Types, 4-22
Printing, 4-22
XB Information , 4-24
Setup, 4-24
Review, 4-24
XB Batch Means, 4-24
XB Batch Details, 4-27
Exclude, 4-27
Graphics, 4-28
Thumbnail Levey-Jennings Graphs, 4-28
Add, Modify and Delete Comments , 4-29
Delete XB, 4-29
Reports, 4-29
Types, 4-29
Printing XB Batch Reports, 4-30
Export XB, 4-31
XM Information, 4-32
Setup, 4-32
Review (Menu > QA > XM), 4-32
View Subsets from the XM Batch Means Screen, 4-33
Summary Statistics, 4-34
Mark as Reviewed, 4-35

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Contents

XM Graph View, 4-36


Group Tabs, 4-36
Thumbnail Levey-Jennings Graphs, 4-36
View XM Batch Details, 4-38
Add, Modify and Delete XM Comments, 4-38
Delete XM, 4-39
XM Reports, 4-40
Types, 4-40
Printing Reports, 4-40
Export, 4-41

CHAPTER 5: Sample Analysis, 5-1


Specimen Collection, 5-1
Specimen Preparation (Pre-dilute), 5-2
Placing the Bar-code Label on the Tube, 5-3
Load Cassettes, 5-4
Cassette Handling, 5-4
Load the Cassette, 5-4
Add a Test Order, 5-6
Automatic Download from LIS, 5-6
Manual Entry (Menu > Worklist > Pending Tab), 5-6
Specimen Information Panel, 5-7
Available Panels, 5-8
Patient Information Panel, 5-9
Add Order Comments (Pending Tab > Add Order > Comments), 5-10
Edit a Test Order (Worklist > Pending Tab > Edit Order), 5-11
Run Samples, 5-12
Status, 5-12
Cassette Presentation, 5-12
Single-tube Presentation, 5-15
Using the Handheld Scanner, 5-18
Studies, 5-19
Batching, 5-19
Handling Alarms, 5-19

CHAPTER 6: Data Review, 6-1


Worklist Screen, 6-1
Worklist Screen Layout, 6-1
Pending Tab(Menu > Worklist > Pending Tab), 6-3
Remove Pending Orders, 6-5
Delete Pending Orders, 6-6
Save Orders, 6-6
Unsave Orders, 6-6
Not Processed Tab(Menu > Worklist > Not Processed Tab), 6-7
Clearing an Exception from the Not Processed Tab, 6-8
Review Tab(Menu > Worklist > Review Tab), 6-9

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Contents

Released Tab(Menu > Worklist > Released Tab), 6-11


Transmit Released Results to the LIS, 6-13
Export Released Results (Released Tab > Export), 6-14
Custom Tab(Menu > Worklist > Custom Tab), 6-15
Custom Tab Filter, 6-15
How to Review Patient Results, 6-17
Dynamic Mode, 6-19
Static Mode, 6-20
From the Worklist Tab, 6-20
Quick Search Mode, 6-20
Description of Histogram/Dataplot Content on the Patient Results
Screen, 6-21
Additional Data , 6-22
Additional Data CBC Tab, 6-23
Additional Data DIFF Tab, 6-24
Additional Data NRBC Tab, 6-25
Additional Data RETIC Tab, 6-26
View All VCSn Graphics , 6-27
View Rules Triggered (Patient Results > More > Rules
Triggered), 6-30
View Collation(Patient Results > More > View Collation), 6-31
View Source (Patient Results > More > View Source), 6-32
View Previous or Next Patient Results, 6-33
View Rerun Tab, 6-34
View History Tab, 6-35
Reflex, 6-36
Rerun, 6-37
View Log, 6-37
Edit Patient Results, 6-38
Processing Results, 6-39
Overview, 6-39
Customization, 6-40
Flags, 6-41
Codes, 6-42
Messages that Appear with Results, 6-43
Suspect, 6-43
System , 6-44
Definitive, 6-47
HGB/HCT Check, 6-48
System Status Messages, 6-49
Exception Messages, 6-50
Lab Actions, 6-51
Comments, 6-51
Release/Reject Results, 6-51
Release Results, 6-51
Reject Results, 6-52
View Rejected Results, 6-52

xii
Contents

Reports, 6-53
Types, 6-53
Printing, 6-53
Specimen Search, 6-54

CHAPTER 7: Workload, 7-1


Workload Management , 7-1
Workload Graph view (Menu > Workload > Graph View), 7-2
Workload Table View (Menu > Workload > Table View), 7-3
Filter Workload by Presentation and Workload Category, 7-3
Export Viewable Workload Data, 7-5
Export Maintenance and ALL Workload Data, 7-6

CHAPTER 8: Shutdown, 8-1


Shutdown Overview, 8-1
System Manager, 8-1
Logoff, 8-1
Shutdown, 8-1
Power Off, 8-1
SPM, 8-2
Daily Shutdown, 8-2
Prolonged Shutdown, 8-3
Extended Shutdown, 8-3
Long Term Shutdown, 8-3
Power Off/Power On, 8-3

CHAPTER 9: Setup, 9-1


Overview, 9-1
Set Up Supplies (Menu > Supplies > Setup), 9-2
Configure Containers (Menu > Supplies > Configure Containers), 9-2
Configure Low Level Condition (Menu > Supplies > Configure Low
Level), 9-3
Set Up DxH Supplies(Menu > Supplies > Setup), 9-5
System Setup (Menu > Setup > System), 9-6
Backup and Recover (Menu > Setup > System > Backup and
Recover), 9-7
Perform Manual Backup (Menu > Setup > System > Backup and
Recover > Manual Backup), 9-8
Database Cleanup (Menu > Setup > System > Database Cleanup), 9-8
Printer Setup (Menu > Setup > System > Printer Setup), 9-10
Date and Time (Menu > Setup > System > Date and Time), 9-11
Bar Code (Menu > Setup > System > Bar-code Setup), 9-13
Discover the Bar-code Label Type, 9-13
Audible Alarms (Menu > Setup > System > Audible Alarms), 9-14
Studies (Menu > Setup > System > Studies), 9-16
Print System Configuration (Menu > Setup > System > System

xiii
Contents

Configuration > Print), 9-17


Restore System Configuration (Menu > Setup > System > System
Configuration > Restore), 9-18
Save System Configuration (Menu > Setup > System > System
Configuration > Save), 9-19
Temporarily Disable Analysis (Menu > Setup > System > Analysis >
Disable Temporarily), 9-20
Permanently Disable Retic Analysis(Menu > Setup > System >
Analysis > Disable Permanently), 9-21
Set Specimen Primary Identification (Menu > Setup > System > More
> Primary Identification), 9-22
Set Instrument Name (Menu > Setup > System > More > Set Instrument
Name), 9-23
Remote Management (Menu > Setup > System > More > Remote
Management), 9-23
Configure Transport, 9-25
Enable Retry Aspiration (Menu > Setup > System > More > Aspiration
Retry), 9-26
Operators and Roles (Menu > Setup > Operators and Roles), 9-27
Add a New Operator (Menu > Setup > Operators and Roles > New
Operator), 9-28
Edit an Existing Operator (Menu > Setup > Operators and Roles > Edit
Operator), 9-29
Reset an Operator’s Password (Menu > Setup > Operators and Roles >
Reset Password) , 9-30
Change Your Password (Menu > Setup > Operators and Roles >
Change Password), 9-31
Set Timeout Settings (Menu > Setup > Operators and Roles > Timeout
Settings), 9-32
Flagging and Rules (Menu > Setup > Flagging Rules), 9-33
Flags (Menu > Setup > Flagging/Rules > Flags), 9-33
Delta Checks (Menu > Setup > Flagging/Rules > Flags > Delta Checks
Tab), 9-34
Flagging Limits (Menu > Setup > Flagging/Rules > Flags > Flagging
Limits Tab), 9-35
Add Action/Critical Limits, Definitive Male, and Definitive
Female Limits, 9-38
H&H Check (Menu > Setup > Flagging/Rules > Flags > Flagging
Limits > H&H Check) , 9-38
Flagging Sensitivity (Menu > Setup > Flagging/Rules > Flags >
Flagging Sensitivity Tab), 9-39
Decision Rules (Menu > Setup > Flagging/Rules > Flags > Decision
Rules Tab), 9-40
Add a Rule, 9-40
Special Information for If Conditions, 9-42
Insert Test Result (Decision Rule Setup > Insert > Test
Result), 9-43

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Contents

Insert Panels, 9-44


Insert Test Flags and Codes, 9-45
Insert Delta Check State, 9-46
Insert Suspect, System, Definitive, or Exception Messages, 9-47
Insert Patient Information, 9-48
Insert Patient ID, 9-48
Insert Patient Age, 9-48
Insert Patient Gender, 9-49
Insert Patient Ethnicity, 9-50
Insert Specimen Age, 9-51
Insert Physician, 9-52
Insert Location, 9-53
Insert Diagnosis, 9-54
Insert Priority, 9-54
Insert Specimen ID, 9-55
Complete the Then Statement, 9-56
Comments (Menu > Setup > Flagging/Rules > Comments), 9-57
Edit Decision Rules, 9-58
Copy Decision Rules, 9-58
Restore Decision Rules, 9-59
Release Rules (Menu > Setup > Flagging/Rules > Release Rules), 9-60
Physicians (Menu > Setup > Flagging/Rules > Physicians), 9-61
Locations (Menu > Setup > Flagging/Rules > Locations), 9-62
Auto Stop (Menu > Setup > Flagging/Rules > Auto Stop), 9-63
Collation (Menu > Setup > Flagging/Rules > Collation), 9-64
Reporting (Menu > Setup > Reporting), 9-65
Lab Information, 9-66
Units Format, 9-67
Label Names, 9-69
Auto Report, 9-70
WBC Options (Menu > Setup > Reporting > WBC Options), 9-72
Patient Report (Menu > Setup > Reporting > Patient Report), 9-73
Enable/Disable Tests, 9-74
Auto Report Daily Checks , 9-75
Demographics (Menu > Setup > Demographics), 9-76
Add Patient Demographics, 9-76
Add or Modify a Comment in Patient Demographics, 9-78
Delete Demographics, 9-80
Edit Patient Demographics, 9-81
Quality Control (Menu > Setup > Quality Control), 9-83
Commercial Controls, 9-83
Auto Configure Beckman Coulter, Inc. (BCI) Controls, 9-84
New Patient Control, 9-85
New BCI Control from Bar-Code, 9-87
New Manual Entry (BCI Control), 9-87
Extended QC Setup, 9-90
Additional Information in Extended QC Setup, 9-91
Edit Control, 9-91

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Contents

Auto Print Setup, 9-92


IQAP Export, 9-93
XB (Menu > Setup > Quality Control > XB), 9-93
XM, 9-96
Shifts, 9-98
Lab Limits, 9-99
LIS Communications (Menu > Setup > Communications > LIS) , 9-100
Install/Upgrade Software (Menu > Setup > Install/Upgrade Software)
, 9-101
Quality Assurance, 9-102
Repeatability, 9-102
Carryover, 9-102
CBC Calibration, 9-102
Setting Calibration Factors for Routine Calibration, 9-103
QA Auto Report, 9-103
Daily Checks Configuration (Daily Checks > Auto Configuration >
Configure Daily checks), 9-104
Automatic Cycling , 9-104
Enable Automatic Daily Checks, 9-104
Enable Automatic Shutdown, 9-105
Default Test Order (Menu > System Status), 9-107
Cassette Aspiration Default Test Order, 9-108
Whole Blood Specimen Type with Test Panel, 9-108
Single-tube Aspiration Default Test Order, 9-109
Whole Blood Specimen Type with default Test Panel with
Addition of Predilute, 9-109
Print Status (System Status > Print Status), 9-110
Batching Enabled, 9-110
Auto Print History Log Configuration , 9-111
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab >
Advanced Search), 9-112
Rules Triggered (Advanced Search Filter Configuration > Insert >
Result > Rules Triggered), 9-113
Lab Action (Advanced Search Filter Configuration > Insert > Result >
Lab Action), 9-114
Action Status (Advanced Search Filter Configuration > Insert > Status
> Action Status), 9-115
Release Status (Advanced Search Filter Configuration > Insert >
Status > Release Status), 9-115
Results Status (Advanced Search Filter Configuration > Insert >
Status > Results Status), 9-116
Saved Status (Advanced Search Filter Configuration > Insert > Status
> Saved Status), 9-117
Specimen Status(Advanced Search Filter Configuration > Insert >
Status > Release Status), 9-118
Analysis Date/Time (Advanced Search Filter Configuration > Insert >

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Specimen
> Analysis/Date Time), 9-119
Draw Date/Time (Advanced Search Filter Configuration > Insert >
Patient > Draw Date/Time), 9-120
Presentation (Advanced Search Filter Configuration > Insert >
Presentation), 9-120
Logged Operator ID (Advanced Search Filter Configuration > Insert >
Operator > Logged Operator ID), 9-121
Operator ID (Advanced Search Filter Configuration > Insert >
Operator > Operator ID), 9-122
Comments (Advanced Search Filter Configuration > Insert >
Comments), 9-122
Chartable Report (Advanced Search Filter Configuration > Insert >
Report > Chartable Report), 9-123
Lab Report (Advanced Search Filter Configuration > Insert > Report >
Lab Report), 9-124
Report Transmitted (Advanced Search Filter Configuration >
Insert > Patient > Draw Date/Time), 9-124

CHAPTER 10: Troubleshooting, 10-1


Precautions / Hazards, 10-1
Radiation Statement, 10-1
Laser Safety, 10-1
Laser Warning Labels, 10-2
EMC Information, 10-4
Disposal of Electrical Instrumentation, 10-4
Waste Disposal Warning, 10-5
Overview, 10-6
General Troubleshooting Techniques, 10-6
Daily Checks, 10-6
Diagnostic Procedures, 10-6
Monitoring the System (Menu > Diagnostics > System Monitor
or (F10)), 10-7
CBC Panel ((F10) > CBC and VCSn), 10-9
STM Panel ((F10) > STM and SAM), 10-10
Reviewing Hardware Information (Menu > Setup > Hardware
Information) , 10-11
Individual Troubleshooting Procedures, 10-12
Remove a Jammed Cassette, 10-12
Verify Aspiration Probe Alignment (Menu > Diagnostics > Dx Tools >
Maintenance), 10-13
ZAP Apertures Procedure (Menu > Diagnostics > Dx Tools >
Maintenance), 10-14
HGB Blank Verification Procedure (Menu > Diagnostics > Dx Tools >
Maintenance), 10-15
Check Pneumatic Supply Procedure (Menu > Diagnostics > Dx Tools >
Maintenance), 10-16
Check Count Vacuum Procedure (Menu > Diagnostics > Dx Tools >

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Contents

Maintenance) , 10-18
Set Count Vacuum Regulator Procedure (Menu > Diagnostics > Dx
Tools > Maintenance), 10-19
Remove Retic Reagents Procedure (Menu > Diagnostics > Dx Tools >
Maintenance), 10-21
Dispense Diluent Procedure (Menu > Diagnostics > Dx Tools >
Maintenance), 10-23
Prime Sweep Flow Procedure (Menu > Diagnostics > Dx Tools >
Maintenance), 10-24
Cycle DV Procedure (Menu > Diagnostics > Dx Tools >
Maintenance), 10-24
Unlock DV Procedure (Menu > Diagnostics > Dx Tools >
Maintenance), 10-25
Verify Blood Detectors Procedure (Menu > Diagnostics > Dx Tools >
Maintenance), 10-25
Flush Flow Cell Procedure (Menu > Diagnostics > Dx Tools >
Maintenance), 10-26
Bar-code Read Rate Procedure (Menu > Diagnostics > Dx Tools >
Maintenance > Barcode), 10-27
Bar-code Alignment Procedure (Menu > Diagnostics > Dx Tools >
Maintenance > Barcode), 10-28
Reset SPM Fluidics(Menu > Diagnostics > Dx Tools >
Maintenance), 10-28
Start Pneumatics Procedure(Menu > Diagnostics > Dx Tools >
Maintenance), 10-29
LIS Diagnostics (Menu > Diagnostics > LIS), 10-29
LIS Filter, 10-30
LIS Export, 10-31
Non-Routine Calibration, 10-32
Database Recovery, 10-32
Event Messages from the SPM, 10-34
Event Messages from the System Manager, 10-72
Event Messages from the System Manager with Action
Required, 10-72
Event Messages from the System Manager that Require No
Action, 10-108

CHAPTER 11: Quality Assurance, 11-1


Calibration, 11-1
When to Verify, 11-1
When to Calibrate, 11-2
Calibrate with COULTER S-CAL Calibrator (Menu > QA > CBC
Calibration), 11-2
Calibrating with Whole Blood, 11-5
Sample Requirements, 11-5
Repeatability (Menu > QA > Repeatability > Repeatability), 11-7

xviii
Contents

Repeatability in Cassette Presentation, 11-8


Repeatability in Single-tube Presentation, 11-9
Repeatability Run Details, 11-9
Carryover (Menu > QA > Carryover), 11-11
Carryover Messages(Menu > QA > Carryover > Messages), 11-14
Exporting Quality Assurance Data, 11-15

CHAPTER 12: Cleaning Procedures, 12-1


When, Why, and How to Perform Each Procedure, 12-1
Remove the Transport Shield, 12-2
Replace the Transport Shield, 12-3
Lift the Front Cover, 12-3
Lower the Front Cover, 12-4
Clean (Bleach) the Apertures, 12-5
Clean the Aspiration Probe, 12-9
Clean the BSV Externally, 12-10
Clean the Pneumatic Supply Module Fan Filter, 12-13
Clean the STM, 12-16
Clean the Air Mix Temperature Control (AMTC) Module, 12-21
Clean the Vacuum Trap, 12-23
Clean the Optical Sensors, 12-26
Clean the Cassettes, 12-27
Clean the Handheld Bar-Code Scanner, 12-28

CHAPTER 13: Replacement / Adjustment Procedures, 13-1


When, Why, and How to Perform Each Procedure, 13-1
Manage Supplies, 13-2
Replace the Aspiration Probe, 13-3
Replace the Front Blood Detector, 13-10
Replace the Count Vacuum Regulator, 13-19
Replace the Pneumatic Supply Module (PSM), 13-25
Unpack the New PSM, 13-25
Remove and Replace the PSM, 13-27
Replace Reagent Containers, 13-33
Replace the Waste Container, 13-36
Replace the Hand-held Bar-Code Scanner, 13-39

xix
Contents

APPENDIX A: Special Equipment, A-1


Bar-Code Label Specifications, A-1
Tube Specifications, A-2
Managing Supplies, A-2

APPENDIX B: Operator Access, B-1


Operator Roles, B-1
Operator Access, B-1

APPENDIX C: Logs, C-1


HIstory Logs (Menu > Logs), C-1
Event Logs (Menu > Logs > Event Logs), C-2
Options on the Event Logs Screen, C-2
Autoprint, C-7
Event Logs - General, C-7
Review Logs, C-7
Data Summary Logs, C-8
Audit Logs, C-9
Maintenance Logs, C-10
Print History Logs, C-12

APPENDIX D: Reports, D-1


Reports, D-1

Glossary, Glossary-1

References, References-1

Index, Index-1

Beckman Coulter, Inc.


Customer End User License Agreement, WARRANTY-1

Trademarks, TRADEMARKS-1

Related Documents

xx
Figures

Figures
1.1 DxH 800 SYSTEM (SPM, PSM, and System Manager), 1-3
1.2 Power Connection, 1-4
1.3 Interunit Power and Signal Cable Connections, 1-5
1.4 SPM Consumable Connections, 1-6
1.5 Front View of SPM, 1-7
1.6 STM Top Level View, 1-8
1.7 Mix Station and Aspiration Probe, 1-9
1.8 Pneumatic Supply Module, 1-12
1.9 DxH 800 System with Optional Floor Stand Front
View, 1-12
1.10 Location of Items in the Floor Stand, 1-13
1.11 System Manager Menu Tree, 1-17
1.12 Home Screen at Log On, 1-18
1.13 QA Menu Selections, 1-20
1.14 Diagnostics Menu Selections, 1-20
1.15 Setup Menu Selections, 1-20
1.16 Advance Menu Selections, 1-20
1.17 Space and Accessibility for the DxH 800, 1-30
1.18 Space and Accessibility Requirements for the DxH 800 with
the Optional Floor Stand, 1-31
2.1 Coulter Method, 2-2
2.2 Tangential Mixing, 2-4
2.3 Sweep Flow, 2-6
2.4 Multi-Transducer Module with Protective Housing Cut
Away, 2-9
2.5 Light Scatter on the DxH 800, 2-10
3.1 Daily Checks - Summary Screen, 3-2
3.2 Daily Checks - System Screen, 3-3
3.3 Daily Checks - NRBC Screen, 3-5
3.4 VCSn Ramp Tests Histograms Screen, 3-6
3.5 Export QA Data Dialog Box, 3-7
4.1 Quality Control (Data View) Screen, 4-3
4.2 Quality Control (Data View) Screen with Extended QC
Enabled, 4-4
4.3 QC Select Controls Dialog Box, 4-7
4.4 Quality Control (Graph View) Screen, 4-8

xxi
Figures

4.5 QC Run Details Dialog Box, 4-11


4.6 Additional Data Dialog Box, 4-14
4.7 QC Comment Dialog Box, 4-15
4.8 QC Filter Dialog Box, 4-16
4.9 Delete Dialog Box, 4-18
4.10 Transmit Dialog Box, 4-19
4.11 Select Control File to Review Dialog Box, 4-20
4.12 Export Quality Control Dialog Box, 4-21
4.13 QC Report Dialog Box, 4-22
4.14 XB Batch Means (Data View) Screen, 4-25
4.15 XB Batch Details Screen, 4-27
4.16 XB Comment Dialog Box, 4-29
4.17 Print XB Batch Reports Dialog Box, 4-30
4.18 XB Batch Export Dialog Box, 4-31
4.19 XM Batch Means (Data View) Screen, 4-33
4.20 Review Batches Dialog Box, 4-35
4.21 XM Batch Means (Graph View) Screen, 4-36
4.22 XM Batch Details Screen, 4-38
4.23 Print XM Batch Reports Dialog Box, 4-40
4.24 XM Batch Export Dialog Box, 4-42
4.25 Select Folder Dialog Box, 4-43
5.1 Placing a Label on a Tube, 5-3
5.2 Example of Cassette with Tubes Loaded Correctly and
Incorrectly, 5-5
5.3 Worklist Screen, 5-6
5.4 Add Order Screen, 5-7
5.5 Find Patient Dialog Box, 5-9
5.6 Comment Dialog Box, 5-10
5.7 Add Comment Dialog Box, 5-10
5.8 Edit Order Screen, 5-11
5.9 Single-tube Presentation Dialog Box, 5-16
6.1 Worklist -Pending Tab, 6-3
6.2 Remove Pending Orders Dialog Box, 6-5
6.3 Delete Orders Dialog Box, 6-6
6.4 Worklist - Not Processed Tab, 6-7
6.5 Clear Exceptions Dialog Box, 6-8
6.6 Worklist - Review Tab, 6-9
6.7 Worklist - Released Tab, 6-11

xxii
Figures

6.8 Transmit Dialog Box, 6-13


6.9 Export Dialog Box , 6-14
6.10 Worklist - Custom Tab, 6-15
6.11 Patient Results Screen, 6-17
6.12 NRBC1, 6-22
6.13 5PD1, 6-22
6.14 RETIC1, 6-22
6.15 Additional Data - CBC Screen, 6-23
6.16 Additional Data -DIFF Tab, 6-24
6.17 Additional Data - NRBC Screen, 6-25
6.18 Additional Data - Retic Screen, 6-26
6.19 View All VCSn Graphics Screen, 6-27
6.20 Surface Plots, 6-29
6.21 3-D Cube, 6-30
6.22 Rules Triggered Dialog Box, 6-30
6.23 Collated Patient Results Example, 6-31
6.24 Collation Source on the Patient Results Screen, 6-32
6.25 Navigation Buttons on the Patient Results Screen, 6-33
6.26 Patient Results - Rerun Tab, 6-34
6.27 Patient Results - History Tab, 6-35
6.28 Select Panel(s) to Reflex Dialog Box, 6-36
6.29 Rerun Dialog Box, 6-37
6.30 Edit Patient Results Dialog Box, 6-38
6.31 Print Specimens Report Dialog Box, 6-53
6.32 Specimen Search Dialog Box, 6-54
7.1 Workload -Graph View Screen, 7-2
7.2 Workload - Table View Screen, 7-3
7.3 Select Folder Dialog Box, 7-5
7.4 Export QA Data Dialog Box, 7-6
8.1 Manual Shutdown Dialog Box, 8-2
9.1 Configure Containers Dialog Box, 9-2
9.2 Configure Low Level Dialog Box, 9-3
9.3 Supplies Screen, 9-4
9.4 Setup Supplies Dialog Box, 9-5
9.5 Backup and Recover Screen, 9-7
9.6 Database Cleanup Dialog Box, 9-9
9.7 Printer Setup Dialog Box, 9-10
9.8 Date / Time Dialog Box, 9-11

xxiii
Figures

9.9 Bar-code Setup and Diagnostics Screen, 9-13


9.10 Configure Audible Alarms - Workstation Dialog Box, 9-14
9.11 Studies Dialog Box, 9-16
9.12 Print Configuration Dialog Box, 9-17
9.13 Restore Configuration Dialog Box, 9-18
9.14 Save Configuration Dialog Box, 9-19
9.15 Disable Analysis Temporarily, 9-20
9.16 Disable Analysis Permanently Dialog Box, 9-21
9.17 Primary Identifier Dialog Box, 9-22
9.18 Configure Instrument Name Dialog Box, 9-23
9.19 Remote Management Dialog Box, 9-24
9.20 Configure Transport Settings, 9-25
9.21 Enable/Disable Aspiration Retry Dialog Box, 9-26
9.22 Operators and Roles Screen, 9-27
9.23 New Operator Dialog Box, 9-28
9.24 Edit Operator Dialog Box, 9-29
9.25 Reset Password Dialog Box, 9-30
9.26 Change Password Dialog Box, 9-31
9.27 Timeout Settings Dialog Box, 9-32
9.28 Delta Checks Tab, 9-34
9.29 Flagging Limits Tab, 9-35
9.30 Flagging Limits Setup - Reference Tab, 9-36
9.31 Example Age Range Dialog Box, 9-37
9.32 H&H Check Dialog Box, 9-38
9.33 Flags Setup - Flagging Sensitivity Screen, 9-39
9.34 Decision Rules Tab, 9-40
9.35 Decision Rule Setup Dialog Box, 9-41
9.36 Insert If Condition Menu Selections for Whole Blood, 9-43
9.37 Test Result Dialog Box, 9-43
9.38 Panels Dialog Box, 9-44
9.39 Test Flags and Codes Dialog Box, 9-45
9.40 Delta Check State, 9-46
9.41 Suspect Messages Dialog Box, 9-47
9.42 Patient ID Dialog Box, 9-48
9.43 Patient Age Dialog Box, 9-48
9.44 Patient Gender, 9-49
9.45 Ethnicity Dialog Box, 9-50
9.46 Specimen Age Dialog Box, 9-51

xxiv
Figures

9.47 Ordering Physician Dialog Box, 9-52


9.48 Insert Location Dialog Box, 9-53
9.49 Diagnosis Dialog Box, 9-54
9.50 Priority Dialog Box, 9-54
9.51 Specimen ID Dialog Box, 9-55
9.52 Select Lab Actions Dialog Box, 9-56
9.53 Lab Actions Setup Dialog Box, 9-57
9.54 Add Lab Action, 9-57
9.55 Add Comment Dialog Box, 9-58
9.56 Restore Decision Rules Dialog Box, 9-59
9.57 Release Rules Dialog Box, 9-60
9.58 Physicians Setup Dialog Box, 9-61
9.59 Add Physician Dialog Box, 9-61
9.60 Locations Setup Dialog Box, 9-62
9.61 Add Location Dialog Box, 9-63
9.62 Configure Auto Stop Settings Dialog Box, 9-63
9.63 Collation Dialog Box, 9-64
9.64 Reporting Screen, 9-65
9.65 Laboratory Information Dialog Box, 9-66
9.66 Test Unit Selection - Whole Blood Screen, 9-67
9.67 Test Unit Selection - Body Fluids Screen, 9-68
9.68 Label Names Dialog Box, 9-69
9.69 Auto Report Criteria Screen, 9-70
9.70 WBC Options Dialog Box, 9-72
9.71 Patient Report Dialog Box, 9-73
9.72 Enable/Disable Tests Dialog Box, 9-74
9.73 Daily Checks Auto Report Dialog Box, 9-75
9.74 Patient Demographics Screen, 9-76
9.75 Add Patient Demographics Dialog Box, 9-77
9.76 Patient Comment Dialog Box, 9-78
9.77 Add Patient Comment Dialog Box, 9-79
9.78 Patient Demographics Delete Dialog Box, 9-80
9.79 Edit Patient Demographics Dialog Box, 9-81
9.80 DxH Dialog Box (Rectify Patient ID), 9-82
9.81 Quality Control Setup Screen, 9-83
9.82 Auto Configure Controls Dialog Box, 9-84
9.83 New Patient Control Dialog Box, 9-85
9.84 Create Control Dialog Box, 9-86

xxv
Figures

9.85 New Manual Entry Control Dialog Box, 9-87


9.86 Create Control (COULTER 6C Cell) Dialog Box, 9-88
9.87 Extended QC Setup - CBC Tab, 9-90
9.88 Additional Information Dialog Box, 9-91
9.89 Auto Print Setup Dialog Box, 9-92
9.90 IQAP Export Dialog Box, 9-93
9.91 Quality Control Setup- XB Tab, 9-94
9.92 Quality Control Setup - XM Tab, 9-96
9.93 Parameter Details - CBC Dialog Box, 9-97
9.94 Quality Control Setup - Shifts Tab, 9-98
9.95 Quality Control - Lab Limits Tab, 9-99
9.96 LIS Screen, 9-100
9.97 Software Component Versions Screen, 9-101
9.98 Software Components Tab, 9-102
9.99 QA Auto Report Configuration Dialog Box, 9-103
9.100 Auto Daily Checks Configuration Dialog Box, 9-105
9.101 Auto Shutdown Configuration Dialog Box, 9-106
9.102 System Status Screen, 9-107
9.103 Print Status Screen, 9-110
9.104 Auto Print Configuration Dialog Box, 9-111
9.105 Advanced Search Filter Configuration Dialog Box , 9-112
9.106 Rules Triggered Dialog Box, 9-113
9.107 Lab Action Dialog Box, 9-114
9.108 Action Status Dialog Box, 9-115
9.109 Release Status Dialog Box, 9-115
9.110 Results Status Dialog Box, 9-116
9.111 Saved Status Dialog Box, 9-117
9.112 Specimen Status Dialog Box, 9-118
9.113 Analysis Date/Time Dialog Box, 9-119
9.114 Draw Date/Time Dialog Box, 9-120
9.115 Presentation Dialog Box, 9-120
9.116 Logged Operator ID Dialog Box, 9-121
9.117 Operator ID Dialog Box, 9-122
9.118 Comments Dialog Box, 9-122
9.119 Chartable Report Dialog Box, 9-123
9.120 Lab Report Dialog Box, 9-124
9.121 Report Transmitted Dialog Box, 9-124
10.1 Laser Warning Label Locations, Protective Housing Cut

xxvi
Figures

Away, 10-3
10.2 Diagnostic Procedures - Maintenance Screen, 10-7
10.3 System Monitor Screen, 10-8
10.4 System Monitor - CBC and VCSn Panels, 10-9
10.5 System Monitor - STM and SAM Panels, 10-10
10.6 Hardware Components Information - Instrument
Screen, 10-11
10.7 Check Pneumatic Supply Dialog Box, 10-16
10.8 Select Baths Dialog Box, 10-18
10.9 Flush FlowCell Dialog Box, 10-26
10.10 LIS Diagnostics Screen, 10-29
10.11 Filter Dialog Box, 10-30
10.12 Export Dialog Box, 10-31
10.13 Exit Workstation Dialog Box, 10-32
11.1 CBC Calibration Screen, 11-2
11.2 CBC Calibration Setup Dialog Box, 11-3
11.3 CBC Calibration (Summary) Screen, 11-4
11.4 Repeatability Screen, 11-7
11.5 Repeatability Setup Dialog Box, 11-8
11.6 Repeatability Run Details Screen, 11-10
11.7 Carryover Screen, 11-11
11.8 Carryover Setup Dialog Box, 11-12
11.9 Carryover Screen (Results), 11-13
11.10 Carryover Messages, 11-14
11.11 Export QA Data Dialog Box, 11-15
C.1 Event Logs -System Status Tab, C-2
C.2 Find Event Dialog Box, C-2
C.3 Event Details Dialog Box, C-3
C.4 Comments Dialog Box, C-3
C.5 Filter Dialog Box, C-4
C.6 Delete Dialog Box, C-5
C.7 History Logs Export Screen, C-6
C.8 History Logs - Event Logs - General Screen, C-7
C.9 History Logs - Data Summary Logs - Daily Checks
Screen, C-8
C.10 History Logs - Audit Log Screen, C-9
C.11 History Logs - Maintenance Logs - Maintenance Tab
Screen, C-10
C.12 New Log Entry, C-11

xxvii
Figures

C.13 Print Dialog Box, C-12


D.1 Patient Lab Report, D-2
D.2 Patient Chartable Report, D-3
D.3 Patient Cumulative Report, D-4
D.4 QC Run Detail Report Page 1 of 2, D-5
D.5 QC Run Detail Report Page 2 of 2, D-6
D.6 QC Summary Report, D-7
D.7 QC Summary Graphical Report, D-8
D.8 Extended QC Summary Report - HCT, D-9
D.9 Extended QC Summary Report RBC, D-10
D.10 Extended QC Summary Report HGB, D-11
D.11 Extended QC Summary Report - WBC, D-12
D.12 XB Batch Details Report (Example) Page 1 of 2, D-13
D.13 XB Batch Details Report (Example) Page 2 of 2, D-14
D.14 XB Batch Means (Example), D-15
D.15 XM Batch Details Report (Example), D-16
D.16 XM Batch Means-RETIC CALC Report (Example), D-17
D.17 Example of Levey Jennings on a Report, D-18

xxviii
Tables

Tables
1.1 Accuracy Specifications, Whole Blood - CBC, 1-33
1.2 Accuracy Specifications (DxH vs. Manual Diff), Whole
Blood - Differential - CLSI H2O-A2, 1-34
1.3 Accuracy Specifications (DxH vs. Predicate), Whole Blood -
Differential, 1-34
1.4 Accuracy Specification, Whole Blood - Reticulocytes, 1-35
1.5 Accuracy Specifications, Whole Blood -NRBC, 1-35
1.6 Accuracy Specifications - Body Fluids, 1-35
1.7 Repeatability - Whole Blood CBC, DIFF, Retic (N=10), 1-36
1.8 Repeatability - Prediluted Blood (N=10), 1-37
1.9 Repeatability - CSF, Serous or Synovial Body Fluid Count
(N=10), 1-37
1.10 Whole Blood Measuring and Operating Ranges, 1-38
1.11 Body Fluids (CSF, Serous, Synovial) Measuring and Operat-
ing Ranges, 1-39
1.12 High to Low Carryover, 1-39
1.13 Background - Daily Checks, 1-40
1.14 Background - Body Fluids*, 1-40
1.15 Throughput per Test Panel Mode, 1-40
1.16 Whole Blood Reference Ranges Overall, 1-41
1.17 Whole Blood Reference Ranges Male, 1-42
1.18 Whole Blood Reference Ranges Female, 1-43
1.19 Sample Stability (Whole Blood), 1-46
1.20 Sample Stability (Pre-diluted Whole Blood), 1-47
1.21 Venous and Capillary Sample Performance
Characteristics, 1-48
1.22 Closed and Open Vial Performance Characteristics, 1-49
1.23 Whole Blood and Pre-Dilute Performance
Characteristics, 1-50
2.1 Parameters and their Derivation, 2-14
5.1 Available Panels, 5-8
6.1 Flags, 6-41
6.2 Codes, 6-42
10.1 Error Event Messages, 10-35
10.2 Warning Event Messages, 10-41
10.3 Info Event Messages, 10-43
10.4 Error Event Messages, 10-72

xxix
Tables

10.5 Warning Event Messages, 10-92


10.6 Info Event Messages, 10-99
10.7 Error Event Messages, 10-108
10.8 Warning Event Messages, 10-110
10.9 Info Event Messages, 10-111
12.1 Matrix of Frequency for Cleaning Procedures, 12-1
13.1 Matrix of Frequency for Replacement Procedures, 13-2
A.1 Printing Parameter’s Specifications, A-1
B.1 Access to Patient Related Functions, B-2
B.2 Access to Quality Control Related Functions, B-3
B.3 Access to Configuration, B-4
B.4 Access to Test Order Management, B-4
B.5 Access to Calibration, B-5
B.6 Access to Report Generation, B-5
B.7 Access to Maintenance/Diagnostics, B-5
B.8 Access to Consumable Management, B-5
B.9 Access to Workload, B-6
B.10 Access to Log Management, B-6
B.11 Access to Manage/Monitor System, B-7
B.12 Access to Installation/Upgrade Category, B-7
B.13 Operator Access to Operating System (OS), B-7

xxx
INTRODUCTION

Overview

This introductory section contains the following topics:


• How to use your UniCel® DxH 800 Coulter® Cellular Analysis System manuals.
• About this manual
• System Help
• Conventions
• Graphics

How to Use Your UniCel DxH 800 Manuals

Use this manual for the day-to-day operations of your Specimen Processing Module (SPM) and
System Manager. Go through the detailed step-by-step procedures of Daily Checks (startup), quality
control (QC), running samples, analyzing data, printing reports, reviewing QC data, and shutdown.
It contains performance specifications, performance characteristics, safety and troubleshooting
information, error messages, in-depth information on the principles of hematology, information
about what your SPM does and the methods it uses, as well as procedures for cleaning the SPM and
replacing reagents and components.
Use the Host Transmission Specification to find the information needed to program the
transmission interface between the DxH 800 System and your laboratory’s host computer.

See the Documentation page on the back of this manual for the contents of each manual. It can help
you to determine quickly in which manual the information you need is located.

629743AE xxxi
INTRODUCTION
About this Manual

About this Manual

NOTE Screens and hardware depicted in this manual may differ slightly from the screens and hardware in
your DxH 800 System configuration.

The information in your Instructions for Use manual is organized as follows:

Chapter 1, System Overview

Provides the intended use of the SPM, the controls and indicators, information on performance, and
information on using the system’s software.

Chapter 2, Operation Principles

Contains a description of the Coulter Method, the normal sample flow, counting and sizing, VCSn
technology, measurement of hemoglobin concentration, and derivation of parameters.

Chapter 3, Daily Checks

Provides information on powering up the SPM followed by Daily Checks.

Chapter 4, Quality Control


Provides information on how to run quality control material to verify SPM setup.

Chapter 5, Sample Analysis

Provides information on specimen collection, placing a bar-code label on a tube, loading cassettes,
adding a test order and running samples.

Chapter 6, Data Review

Provides information on reviewing and interpreting sample results, including flagged results.

Chapter 7, Workload

Provides information on the Workload screens.

Chapter 8, Shutdown

Provides information on correctly shutting down the SPM.

Chapter 9, Setup

Provides information on setting up your system, including, but not limited to, supplies, operators
and roles, flagging and rules, reporting, patient demographics, and quality control.

Chapter 10, Troubleshooting

Describes safety precautions, operational hazards, troubleshooting, what warning messages mean,
system errors, and troubleshooting guides.

xxxii 629743AE
INTRODUCTION
About this Manual

Chapter 11, Quality Assurance

Provides an overview of calibration, instructions for precalibration checks, repeatability, carryover


and calibration.

Chapter 12, Cleaning Procedures


Provides general cleaning procedures.

Chapter 13, Replacement / Adjustment Procedures

Contains the component locations and replacement procedures for reagents and components, and
preparing to ship the SPM.

This manual also includes APPENDIX A - Special Equipment, APPENDIX B - Operator Access,
APPENDIX C - Logs, APPENDIX D- Reports, References, a Glossary, and an Index.

Conventions
This manual uses the following conventions:
• Bold font indicates buttons on the System Manager screen.
• Italics font indicates screen text displayed by the System Manager.
• The term select is used to indicate either one or both of the following actions:
— to tap or touch with your finger
— to click with a mouse
• The instructions in this manual are presented at the Lab Administrator level. For levels of access
for other types of operators, refer to APPENDIX B.

IMPORTANT IMPORTANT is used for comments that add value to the step or procedure being performed.
Following the advice in the IMPORTANT adds benefit to the performance of a piece of equipment or to a
process.

NOTE NOTE is used to call attention to notable information that should be followed during use, or
maintenance of this equipment.

System HELP
The DxH 800 System has comprehensive System HELP, which includes reference information, all operating,
maintenance and troubleshooting procedures.

Select the HELP icon at the top right of any screen on the System Manager to access
System Help.

629743AE xxxiii
INTRODUCTION
About this Manual

Graphics

All graphics, including screens and printouts, are for illustration purposes only and must not be used for any
other purpose.

xxxiv 629743AE
CHAPTER 1

System Overview

Intended Use

The UniCel® DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro
diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800
Analyzer provides a:

• Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and
Nucleated Red Blood Cell (NRBC) on whole blood
• Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous
and synovial) (BF)

629743AE 1-1
System Overview
Intended Use

Parameters
The system determines these hematologic parameters:

WBC White Blood Cell count


UWBC Uncorrected White Blood Cell count
RBC Red Blood Cell count (for Whole Blood and Body Fluids)
HGB Hemoglobin
HCT Hematocrit
MCV Mean Corpuscular Volume
MCH Mean Corpuscular Hemoglobin
MCHC Mean Corpuscular Hemoglobin Concentration
RDW Red Cell Distribution Width
RDW-SD Red Cell Distribution Width Standard Deviation (SD)
PLT Platelet count
MPV Mean Platelet Volume
NE Neutrophil percent
LY Lymphocyte percent
MO Monocyte percent
EO Eosinophil percent
BA Basophil percent
NE# Neutrophil absolute number
LY# Lymphocyte absolute number
MO# Monocyte absolute number
EO# Eosinophil absolute number
BA# Basophil absolute number
NRBC Nucleated Red Blood Cell percent
NRBC# Nucleated Red Blood Cell absolute number
RET Reticulocyte percent
RET# Reticulocyte absolute number
MRV Mean Reticulocyte Volume
IRF Immature Reticulocyte Fraction
TNC Total Nucleated Cell (Body Fluids)

1-2 629743AE
System Overview
UniCel DxH 800 SYSTEM 1

UniCel DxH 800 SYSTEM

Figure 1.1 DxH 800 SYSTEM (SPM, PSM, and System Manager)

1 2

4 5

00
04
1
00041
00042
00043
00044 A
00045

d
POWE
R ON
PUMP
RUNN PNEU
PULL ING MATIC
TO FAULT
ADJUST

Component Function
1. Specimen Processing Module (SPM) Processes patient specimens and sends raw data to the System Manager.
2. System Manager • Controls processes, such as analysis and diagnostic procedures.
• Produces test results.
• Manages data, such as test ordering, results review, results release, quality
control, LIS interface, logging, and report generation.
• Includes an LCD flat panel monitor with touch screen capability, a computer with
CD/DVD RW drive running Microsoft® Windows® XP Professional operating
system, the DxH 800 software, a standard keyboard, and an optical mouse.
3. Hand-held bar-code scanner Reads bar-code labels on specimen tubes.
4. Pneumatic Supply Module (PSM) Supplies vacuum and pressure to the SPM.

629743AE 1-3
System Overview
Hardware

Hardware

Overview
The DxH 800 System includes a Specimen Processing Module (SPM), a Pneumatic Supply Module
(PSM), and a System Manager, precisely integrated to provide process control, data consolidation,
and cassette or single-tube delivery of specimens. See Figure 1.1.

Inter-Unit Connections
Power and Signal Cables
Figure 1.2 shows the warning label at the back of the SPM that alerts you to the possible presence
of AC Voltages.

WARNING
To avoid electric shock, use caution as AC Voltages may be present.

Figure 1.2 Power Connection

Figure 1.3 shows the inter-unit connections of the power and signal cables that are supplied with
the instrument. Your Beckman Coulter Representative makes these connections when installing the
instrument.

NOTE The colors used in Figure 1.3 are for illustration only, they are representative of the colors of the actual
connections.

1-4 629743AE
System Overview
Hardware 1

Figure 1.3 Interunit Power and Signal Cable Connections

IVD

Assembly No. Serial No.

xxxxxx
DxH 800 ANALYZER VOLTS 100-240 AMPS 8.0-2.8
Beckman Coulter, Inc.
4300 N. Harbor Blvd. HZ 48-62 WATTS 720
Fullerton, CA 92835 USA

LIS
VACUUM
RETIC DIFF NBBC
WASTE 1 WASTE 2 STAIN LYSE STAIN

PRESSURE CLEANER DILUENT 2 DILUENT 1

RETIC DIFF CBC


CLEAR PRE LYSE
WASTE SENSOR 1 WASTE SENSOR 2

VACUUM PRESSURE
RMS

9743307B

629743AE 1-5
System Overview
Hardware

The figure below shows the connections between the SPM and the consumable reagents and waste
containers.

NOTE The colors in Figure 1.4 show inter-related tubing and packing connections. Refer to
Figure 9.3, Supplies Screen for additional information on the correlation of these colors to supply status
graphics on the Supplies Screen. Refer to Replacing Reagents for information on replacing the reagents.

Figure 1.4 SPM Consumable Connections

IVD

Assembly No. Serial No.

xxxxxx
DxH 800 ANALYZER VOLTS 100-240 AMPS 8.0-2.8
Beckman Coulter, Inc.
4300 N. Harbor Blvd. HZ 48-62 WATTS 720
Fullerton, CA 92835 USA

VACUUM
RETIC DIFF NBBC
WASTE 1 WASTE 2 STAIN LYSE STAIN

PRESSURE CLEANER DILUENT 2 DILUENT 1

RETIC DIFF CBC


CLEAR PRE LYSE
WASTE SENSOR 1 WASTE SENSOR 2

VACUUM PRESSURE

Cell
LYSE DxH800 DILUENT
DxH800 DILUENT

1-6 629743AE
System Overview
Hardware 1

Front View of the SPM


Figure 1.5 Front View of SPM

The components called out in the figure above are as follows:

1. Beacon The light at the top of the SPM is a Beacon to visually alert
you to conditions that require attention.
2. Status Lights The Status Lights on the front of the SPM are green, yellow
and red LED lights.
3. Input Buffer Place specimen cassettes here.
4. Power Button with ON/OFF Indicator The power button allows you to turn the SPM on and off.
5. Output Buffer The area where you remove cassettes that have been
processed.

Functional Modules
The SPM is made up of the following functional modules.

• Specimen Transport Module (STM)


• Sample Aspiration Module (SAM)
• VCSn Module
• CBC Module
• Common Services

629743AE 1-7
System Overview
Hardware

Specimen Transport Module


The STM automatically transports specimens. It delivers closed-vial and open-vial specimens
accommodating a wide range of specimen tubes. The STM supports the following:

• Operator loading and unloading of specimens


• Transport and queuing of specimens
• Mixing and presentation of specimens

The STM uses a Magnetic Transport System to move cassettes containing specimens. .

Figure 1.6 STM Top Level View

i
c

h
d

g f e
The components called out in the figure above are as follows:

1. Input Buffer Pushers


2. Input Buffer
3. STAT Cassette Position
4. Single-tube Presentation Station
5. Pending Buffer
6. Mix Station
7. Output Buffer Pusher
8. Output Buffer

1-8 629743AE
System Overview
Hardware 1

Input Buffer
The input buffer is where you place specimen cassettes. The capacity is 20 cassettes. The STM
magnetically sweeps the cassettes forward for transport to the mixing station.

Single-tube Station with Cradle

The Single-tube Station cradle accepts many


sizes of tubes. The right position is optimized for
minimal dead volume sampling from the open
vial tubes from 7 to 13 mm in diameter. The left
position accepts open and closed vials from 12
to 16 mm in diameter. A fixed bar-code reader
reads the bar-code labels at or near the
depression on the cover in front of the Single-
tube Station.
At the right position, the minimum tube height
required is 30 mm. The left position minimum
tube height is 55 mm (measured from under
the cap). The maximum height for both sides is
107 mm (with the cap if present).

Pending Buffer
The pending buffer is a temporary holding place for a single cassette while it is in transit, or waiting
for repeat or reflex testing. A cassette in the pending buffer blocks the path of a cassette from the
input buffer to the mixer wall. Thus, a cassette in the pending buffer has higher priority than
cassettes in the input buffer and must be cleared out before a cassette can exit the input buffer.

Mix Station and Aspiration Probe


Figure 1.7 Mix Station and Aspiration Probe

The Mix Station is the area where the Specimen ID is read; the specimen is mixed by rocking 11
times; and, the sample is aspirated by the aspiration probe. Additionally, the specimens are mixed
four times between aspirations.

629743AE 1-9
System Overview
Hardware

Output Buffer
Upon completion of their operation, cassettes are transported to the output buffer to await their
removal. The output buffer is an output area capable of holding up to 20 cassettes.

Sample Aspiration Module


The SAM aspirates from capped specimen tubes (presented via Cassette or Single-tube
presentation) or open vials (Single-tube presentation). Body fluids are presented via Single-tube,
while whole bloods can be presented in either presentation mode. The identification and integrity
of samples are verified prior to delivery and transfer to the analytical modules within the system.
The SAM design provides for two methods of sample delivery: sample segmentation and sample
dispensing. In sample segmentation, aspirated sample is transferred through the BSV where it is
segmented for whole blood CBC and body fluid. In sample dispensing, whole blood sample segments
are then dispensed via the aspiration probe into the mixing chambers on the Air Mix Temperature
Control Module (AMTC) for the WBC differential, NRBC and reticulocyte analyses.

Aspiration Syringe
The aspiration syringe controls the volume and rate of sample aspiration. It is precisely controlled
by a stepper-motor driven aspiration syringe.

Blood Detectors
Two blood detectors are located one on each side of the BSV. The front detector is located between
the top of the aspiration probe and the front port of the BSV. The rear detector is located between
the rear BSV port and the aspiration syringe. The blood detectors monitor the passage of the sample
through the aspiration process and can differentiate between blood, air, and diluent.

BSV
When the sample reaches the BSV it is segmented for CBC analysis within the CBC module.

Aspiration Probe
The aspiration probe allows for sampling from both closed and open specimen tubes. The aspiration
probe pierces through the cap to allow sample aspiration.

The aspiration probe moves depending on the tube presentation position. Once sample has been
aspirated it can move to the mixing chambers to allow sample to be dispensed for other analyses.

1-10 629743AE
System Overview
Hardware 1

Bar-code Reader
The 2D compatible digital barcode reader (camera) does the following:

• Provides for positive identification for all specimen tube IDs in the form of an image.

• Reads the cassette and specimen IDs twice prior to aspiration. Each read includes a minimum
of 10 passes.

• Supports symbologies as small as 7 mil and larger and includes Code 128, Codabar, NW7, Code
39 and Interleave 2 of 5.
• Reads a maximum number of 22 characters plus checksum.

VCSn Module
The VCSn Module provides the physical processing elements necessary for the Differential, NRBC,
and Retic sample preparation and subsequent measurement. The VCSn Module includes the
Distribution Valve (DV), Air Mix Temperature Control (AMTC) module, Multi-transducer Module
(MTM) and their associated electronic and fluidics. Samples prepared at the AMTC are delivered to
the MTM where the sample detection occurs.

NOTE The VCSn module is described in more detail in the Operation Principles chapter of this manual.

CBC Module
The CBC Assembly provides the physical processing elements necessary for CBC sample
conditioning (combining of reagents and the sample segment, mixing and incubation) and
measurement via the aperture bath assemblies, the HGB assembly and the electrical signal
conditioning circuits.

NOTE The CBC module is described in more detail in the Operation Principles chapter of this manual.

Common Services
Common Services consist of the Electronic Supply Module, Pneumatic Services and Reagent
Services (supply and distribution). Common Services provides and monitors electronic power and
supplies and monitors the reagent and waste levels as well as the pressure and vacuum.

629743AE 1-11
System Overview
Optional Floor Stand

Pneumatic Supply Module (PSM)


The Pneumatic Supply Module (PSM) is the source of vacuum and pressure to Common Services.

Figure 1.8 Pneumatic Supply Module

POW
ER ON
PUMP
RUNNIN PNEUMA
PULL G TIC
TO FAULT
ADJU
ST

Optional Floor Stand

Figure 1.9 DxH 800 System with Optional Floor Stand Front View

1-12 629743AE
System Overview
Optional Floor Stand 1

The Floor Stand, Figure 1.9, provides self-contained support for the SPM as well as easy access
storage for reagents and waste containers. Additionally, the Floor Stand houses the Pneumatic
Supply on an integrated pull-out shelf. in the left lower section of the cabinet.

Reagents are placed on slide-out drawers. The upper right drawer holds two 10L diluent containers.
The lower right drawer contains two 10 L waste containers. Non-diluent reagents and cleaner are
placed in the left upper drawer.

Figure 1.10 Location of Items in the Floor Stand

NT
UE
DIL
00
H8
Dx
NT
UE
DIL
00
H8
Dx
d DxH
800
ENT
DILU

ENT
DILU
800
DxH

POWE
R ON
PUMP
RUNNI PNEUM
PULL NG ATIC
TO FAULT
ADJUST

b
e
c
1. Two 10L diluent containers
2. Two 10L waste containers
3. Cell Lyse, Diff Pack, Retic Pack, and Cleaner
4. Pneumatic Supply Module (PSM)

629743AE 1-13
System Overview
Optional Floor Stand

Accessing Items Contained in the Floor Stand

1 Open the floor stand doors.

2 Pull out the top left or right drawer to access reagents.

1-14 629743AE
System Overview
Optional Floor Stand 1

In the top right drawer, Diluent 1 is located in the back and Diluent 2 is at the front of the
drawer.

3 Pull out the bottom right drawer to access the waste containers. Waste 1 is located in the back
and Waste 2 is at the front of the drawer.

629743AE 1-15
System Overview
Optional Floor Stand

4 Unlock the latches on the bottom left drawer to pull out the pneumatics drawer and access the
Pneumatic Supply Module (PSM). .

5 Lock the latches at the bottom of the left drawer when the drawer is closed.

1-16 629743AE
System Manager Indicators
629743AE

The System Manager features touch screen capability that allows you to tap the Status icons and Menu buttons on the screen.

Figure 1.11 System Manager Menu Tree


Menu

Patient Daily System


Pending Summary Dx Tools Maintenance
Results Checks
System CBC
Add Order
Background VCSn
System Not Processed Supplies System SAM Operators
QC
Status Review CBC Monitor STM and Roles
Released DIFF Common Services
Custom RETIC
Worklist XB NRBC LIS Flagging/
Rules
CBC
CBC
QA XM DIFF Reporting
RETIC VCSn
RETIC CALC Controls
XB Setup
Supplies Repeatability STM Demographics XM Setup
Shifts
Event Logs
SAM Lab Limits
Data Summary Logs Quality
Logs Carryover
Audit Logs Control
Maintenance Logs
Volt/Temp
CBC
Workload Communications LIS
Calibration Common
Serv

Diagnostics DxH 800


Install/Upgrade
Software Software

System Manager Indicators


Components
Setup Accessories Paint
Instrument
Hardware System

System Overview
Windows Information CBC
Advanced Wordpad VCSn
Explorer
STM
Raw SAM
About DxH 800 Fast User Data Reagent
Switching Pneumatic
1-17

1
System Overview
System Manager Indicators

Home Screen
The Home screen is the default startup screen of the System Manager.

Figure 1.12 Home Screen at Log On

The sections of the Home screen that are called out in the figure above are as follows:

1. Status Area
2. Navigation Icons
3. Local Navigation Bar
4. Status Bar
5. Alert Status Icons
6. Utility Icons
7. System Icons

1-18 629743AE
System Overview
System Manager Indicators 1

Global Menu Button


The global Menu button allows you to navigate through the system. Select Menu to display available
application buttons. Select any application button to display the screen for the selected
functionality.

Displays the Patient Results screen in dynamic mode

Displays the System Status screen.

Displays the Worklist screen.

Displays a pop-up menu of QA selections.

Displays the Supplies screen.

Displays the History Logs screen.

Displays the Workload screen.

Displays a pop-up menu of Diagnostic menu selections.

Displays a pop-up menu of Setup menu selections.

Displays a pop-up menu of Advanced menu selections.

629743AE 1-19
System Overview
System Manager Indicators

Figure 1.13 QA Menu Selections Figure 1.14 Diagnostics Menu Selections

Figure 1.15 Setup Menu Selections Figure 1.16 Advance Menu Selections

1. Windows Explorer displays the My Computer window.


2. Fast User Switching allows the current user to log out of
the operating system software.

1-20 629743AE
System Overview
System Manager Indicators 1

Global Icons and Navigation/Status Buttons

Previous/Next Icons

The Previous Screen/Next Screen icons at the top-left corner of any screen allow you to go back or
forward a maximum of five times. The screen content from previously viewed screens will be
relative to recent information. The left arrow allows you to move back to previously viewed
screens. The right arrow allows you to move forward to previously viewed screens.

Single-Tube Presentation Icon

The Single-tube Presentation icon at the top-left corner of every screen displays the Single-tube
Presentation dialog box when selected.

Status Area

The top-left corner of every screen is the Status Area. The top Status field displays the current
status, for example, Online, Offline, Standby, Special Online, etc. The lower Status field displays
special states such as Studies.
Whenever the SPM is in Special Online procedure mode, the status field will display one of the
following: Calibration, Repeatability, Carryover, or Diagnostics.

629743AE 1-21
System Overview
System Manager Indicators

Status Bar

The Status Bar, at the bottom of every screen, displays the following:

• Last event message (left side of the bar)


• Operator ID of the logged on operator (middle of the bar)
• Date and Time (right side of the bar)

Alert Status Icons

The Alert Status icons always display at the top of the screen. The alert status icons provide
navigation to specific applications and function to alert you to conditions that require attention.
The icons display in red or yellow if attention is required. For example:

The Alert Status icons are as follows:

System Status Indicates the system’s status. Select this icon to display the
System Status screen.

Review Result Indicates the status of specimen results. Select this icon to
display the Worklist screen and the Worklist Filter tabs.

Daily Checks Indicates the status of Daily Checks. Select this icon to display the
Daily Checks screen.

QC Indicates the status of a QC run. Select this icon to display the


Quality Control screen.

XB/XM Indicates the status of an XB/XM run. Select this icon to display
the XB/XM Review screens. Double tapping on this icon switches
between the XB and XM applications.

1-22 629743AE
System Overview
System Manager Indicators 1

Supplies Indicates the status of the supply level. Select this icon to display
the Supplies screen.

Event Log Indicates the status of the General Tab in the Event Log. Select
this icon to display the History Logs screen.

Utility Icons

The Utility icons always display in the top right-hand corner of the screen and include the
following:

Print Prints a report for the active screen. The content of the dialog
will change depending on the selected contents of the active
screen.
Specimen Search Displays the Specimen Search dialog box.

Help Displays the Help Topics associated with the active screen.

Logoff Displays the application’s Logon/Logoff dialog box.

629743AE 1-23
System Overview
System Manager Indicators

System Icons

The System icons always display at the top of the screen just under the Utility icons and include the
following:

Start Places the SPM online for processing.

Stop Places the SPM offline and stops processing.

Turn Off Alarm Turns off the audible alarm when it is triggered.

Local Navigation Bar


The Local Navigation Bar displays at the bottom of every screen. The active buttons change
depending on the screen that is open.

1-24 629743AE
System Overview
Consumables and Supplies 1

Consumables and Supplies

Recommended Reagents
COULTER® DxH Diluent

COULTER DxH Diluent is a cyanide-free, isotonic buffered saline solution. COULTER DxH Diluent
dilutes the specimen, is used for rinsing SPM components between sample analyses, and provides a
sheath stream to transport the sample through the flow cell.

CAUTION
The DxH 800 can sample from multiple reagent containers. Do not mix the diluent
lot numbers.

COULTER® DxH Cell Lyse

COULTER DxH Cell Lyse is a cyanide-free CBC lytic reagent that lyses red blood cells for the white
blood cell count, and works in conjunction with COULTER DxH Diluent to generate a stable
hemoglobin measurement.

COULTER DxH Cell Lyse is also used to lyse the red blood cells and discriminates nucleated red blood
cells from white blood cells.

COULTER® DxH Diff Pack

The COULTER DxH Diff Pack consists of the Erythrolyse™ Lytic Reagent and StabiLyse™
Preservative Reagent. The Erythrolyse Lytic Reagent is a cyanide-free lytic reagent that dilutes the
blood sample, and lyses red blood cells in preparation for white blood cell measurement in the flow
cell. The StabiLyse Preservative Reagent neutralizes the Diff lytic reagent and preserves the white
blood cells for measurement in the flow cell. Together, Erythrolyse and StabiLyse provide the five-
part differential.

COULTER® DxH Retic Pack

The DxH Retic Pack consists of a reticulocyte stain reagent and a reticulocyte-clearing reagent.The
reticulocyte stain reagent is a cyanide-free reagent that uses a dye to stain reticulocytes. The
reticulocyte-clearing reagent is a cyanide-free reagent that stabilizes the dye-reticulum complex to
enhance discrimination of reticulocytes from mature red blood cells utilizing the VCSn technology.

COULTER® DxH Cleaner

DxH Cleaner is a cyanide-free, aldehyde-free cleaning agent that degrades residual materials so that
they may be flushed from the system with the diluent.

629743AE 1-25
System Overview
Consumables and Supplies

Material Safety Data Sheets (MSDS)


To obtain an MSDS for Beckman Coulter reagents used on the DxH 800, go to
www.beckmancoulter.com or in the USA, write to:

Beckman Coulter, Inc.


Attn: MSDS Requests
P.O. Box 169015
Miami, FL 33116-9015

Outside the USA, contact your Beckman Coulter Representative.

Recommended Controls and Calibrators


COULTER® 6C Cell Control

The COULTER 6C Cell Control is an integrated control that enables monitoring of system
performance and calibration status for all directly measured and calculated CBC, Diff and NRBC
parameters.

COULTER® Retic-X Cell Control

The COULTER Retic-X Cell Control is a control recommended for monitoring system performance
of the reticulocyte parameters.

COULTER® LIN-X Linearity Control

COULTER LIN-X Linearity Control is recommended for verification of the reportable range and
linearity, and calibration assessment of the WBC, RBC, HGB, and PLT parameters.

COULTER® Body Fluid Control

COULTER Body Fluid Control is recommended for monitoring system performance of the body fluid
cycle’s RBC and TNC count parameters. Additionally, COULTER Body Fluid Control can be used for
verification of the reportable range and linearity of the TNC and RBC in the body fluid panel.

COULTER® LATRON™ CP-X Control

COULTER LATRON CP-X Control is recommended for the verification of the system calibration
status of the VCSn parameters. COULTER LATRON CP-X control checks alignment of the laser and
flow cell on the DxH 800.

COULTER® S-CAL® Calibrator

The COULTER S-CAL Calibrator is traceable to reference methods and recommended for
determining adjustment factors to ensure accurate SPM measurements of directly measured CBC
parameters. Calibrator results should be monitored with COULTER 6C Cell Control.

1-26 629743AE
System Overview
Consumables and Supplies 1

Cassettes

7-13mm

12-16mm

00
04
1
00
04
1
000000441
1 D
000042
00043 00041 00042 00043 00044 00045
00044 C
00045
00041
00042
00043
00044 A
00045

C D

The DxH 800 uses a five-position cassette in accordance with the CLSI standard for automation. The
cassettes contain metal inserts for use with the Magnetic Transport System. The cassettes also
include grooves that interlock with the mix station hardware to secure the cassettes to the mix
station. The cassette types are outlined below.

NOTE For a complete tube list, please visit our Web site at www.beckmancoulter.com.

Cassette Type A
Cassette Type A uses gray liner with a purple insert and handles tubes with an outside diameter
between 12 and 16 mm.

Cassette Type C
Cassette Type C uses black liner with green insert and handles tubes with an outside diameter
between 7 and 13 mm.

Cassette Type D
Cassette Type D uses black liner with green insert and handles tube with an outside diameter
between 7 and 13 mm, and includes a green insert for shorter tubes, that is, any tube shorter than
a control tube (for example, 2 mL and 3 mL pediatric tubes).

Bar-code Labels
Each cassette has a label that identifies five contiguous tube sites, identifiable by a 2D bar-code
symbol that is readable by the bar-code reader as well as human readable text. All Cassette IDs
within any single lab must be unique.

629743AE 1-27
System Overview
Physical Specifications

Physical Specifications

SPM Temperature and Humidity Specifications

Temperature
The SPM configured with DxH consumables will meet performance requirements at a temperature
of +15.5°C to 32°C or 60°F to 90°F.

Humidity
The DxH 800 System operates at the following relative humidity (non-condensing) and temperature
limits:

• RH < 85% at 60 to 84°F (16 to 29°C)


• RH < 70% at > 84 to 90°F (29 to 32°C)

Power
The instrument requires:

• An independent protected circuit.


• A three-wire NEMA 5-20R (120 Vac, 20A) receptacle furnishing single-phase input power for
105-120 V, 20A DxH 800 Systems.
• A ground path cable capable of carrying the full current of the circuit (confirmed third-wire
earth ground).
• An independent and protected circuit.
• The 3m (10 ft) primary power cord on the rear of the SPM must be plugged directly into the
receptacle. Do not use an extension cord.

Input
100–240 VAC, 8.0 - 2.8 AMPS, and 48–62 Hz

Consumption
The power consumption is:

• DxH 800 SPM, 700 W


• DxH 800 System with System Manager and Printer, 1185 W
• DxH 800 System with System Manager, Printer, and UPS, 2390 W

1-28 629743AE
System Overview
Physical Specifications 1

Installation Category
The SPM is in Installation Category II.

Pollution Degree
The pollution degree of the SPM is 2.

Acoustic Noise Level


Measure Level 60dBa or less.

Dimensions (Depth, Width, Height) and Weight

Depth Width Height Weight


SPM 31.0 inches 30.0 inches 38 inches 260 lbs
(78.7 cm) (76.2 cm) (96.5 cm) (117.5 kg)
Pneumatic Supply 20.0 inches 8.5 inches 14.5 inches 40.5 lbs
(51.0 cm) (21.6 cm) (36.8 cm) (18.4 kg)
Optional Floor Stand 31.0 inches 30.0 inches 33.0 inches 277 lbs
(78.7 cm) (76.2 cm) (83.8 cm) (125.6 kg)

629743AE 1-29
System Overview
Physical Specifications

Space and Accessibility Requirements

IMPORTANT The DxH 800 meets the immunity requirements for RF and other interference from electronic
devices as required by the product level standards EN 61326-1 (Electrical Equipment for Measurement,
Control, and Laboratory Use -EMC Requirements), and EN61326-2-6 (Part 2, specific requirements for In-
vitro Diagnostic Devices).”

Figure 1.17 Space and Accessibility for the DxH 800


96.5 cm
(38.0 in)

104.1 cm
)
78. (41.0 in
0
H 80

7
em
l Dx

cm
Syst
ysis
UniCe r Anal

(31 cm
Cella
ter
Coul

.0 i 76.2 in) 3.8


n) 0 . 0 1
(3 (1.5 cm cm
in) 15.2 n.)
. 0 i
(6

cm
800
DxH is System

15.2 n.)
Cel Analys

2.54 cm
Unilter Cellar
Cou

i 1.2 cm
(6.0 (1.0 in)
(0.5 in)
1.2 cm
(0.5 in)
36.8 cm
(14.5 in)

51.0 cm
(20.0 in) 21.6 cm
(8.5 in)

1-30 629743AE
System Overview
Physical Specifications 1

Figure 1.18 Space and Accessibility Requirements for the DxH 800 with the Optional Floor Stand

21.6 cm
(8.5 in.)

104.1 cm
(41.0 in.)
96.5 cm
(38.0 in.)
cm
15.2 n.)
i
(6.0

cm
15.2 n.)
i
(6.0
800
xH System
el DAnalysis
UnultiC
er Ce
llar
Co

m
83.8 c )
0 in .
(33.

m
3.8 c .5 in.) 78.7 7 cm
(1 (31. cm 75.5 in.)
0 in 75
.) (29.

Software Specifications
Software Application Module

The software application module provides you with the following data storage capabilities:

• 40,000 patient results with graphics.


• 12,000 CBC/Diff/Retic/NRBC raw data files.
• 30 control files, each with a minimum of 150 runs.

629743AE 1-31
System Overview
Performance Specifications and Characteristics

Performance Specifications and Characteristics

Anticoagulant
NOTE All performance claims in this manual are based on data from specimens collected into the
anticoagulants indicated below.

CAUTION
These anticoagulants are recommended by Beckman Coulter. Use of other
anticoagulants may yield misleading results.

CAUTION
Follow the tube manufacturer’s recommended procedure for the correct specimen
collection.

For the recommended anticoagulant is


Whole blood K2 or K3 - EDTA
prediluted anti-coagulated blood
Serous fluids
Synovial fluids (pretreated with K2 or K3 - EDTA, or heparin
Hyaluronidase)

Aspiration
DxH 800 aspiration volume is 165μL.

Pre-diluted blood CBC analysis requires a dilution of 50μL of blood and 200μL of diluent.

DxH 800 Sample Preparation


The DxH 800 will process specimens as indicated below.

Automated Cassette: Whole Blood Closed Vial


Single-tube Station: Whole Blood Closed Vial and Open Vial
Body Fluid Closed Vial and Open Vial
Pre-dilute Open Vial

1-32 629743AE
System Overview
Performance Specifications and Characteristics 1

Accuracy
Whole Blood - CBC

Accuracy for the CBC parameters is assessed by comparison of the results from the DxH 800 and a
comparative method. The estimation of the difference is determined as described in CLSI EP09-A2
Method Comparison and Bias Estimation Using Patient Samples. When specimens covering the
measuring range with no system messages are analyzed by both the DxH 800 and another
automated hematology analyzer, the DxH 800 meets specification if the results are within the limits
defined in the table below.

Table 1.1 Accuracy Specifications, Whole Blood - CBC

Parameter Units Measuring Range Difference


(whichever is greater)
WBC x103/μL 0.000–2.000 ±0.1 ±10%
>2.000–100.000 ±0.2 ±3.0%
>100.000–400.000 N/A ±5 %
RBC x106/μL 0.000–8.500 ±0.05 ±2.0%
HGB g/dL 0.00–25.50 ±0.2 ±3.0%
MCV fL 50.00–150.00 N/A ±2%*
RDW % 10.00–40.00 ±0.5 ±5.0%
RDW-SD fL 15.00–220.00 ±3.0 ±10.0%
PLT x103 /μL 0.0–3000.0 ±10.0 ±7.0%
MPV fL 5.00-25.00 N/A ±7.0%

*Due to the effect of temperature on red cell size, the specification applies to the temperature range
of 70–80° F (21.1–26.7° C).

629743AE 1-33
System Overview
Performance Specifications and Characteristics

Differential
Accuracy for the Differential parameters is assessed by comparison of the results from the DxH 800
and a comparative method. Results may be compared to either an automated hematology analyzer
or to a 400 cell manual differential prepared according to CLSI H20-A2 Reference Leukocyte (WBC)
Differential Count (Proportional) and Evaluation of Instrumental Methods (H20).

The estimation of the bias/difference is described in CLSI EP09-A2 Method Comparison and Bias
Estimation Using Patient Samples. When specimens covering the measuring range with no System
messages are analyzed by the DxH 800, and by 400 cell manual differential, the DxH 800 meets
specification if the results are within the Bias defined in Table 1.2. below.

Table 1.2 Accuracy Specifications (DxH vs. Manual Diff), Whole Blood - Differential - CLSI H2O-A2

Parameter Units Measuring Range Bias


(whichever is greater)
NE % 0.00–100.00 ±2.0 ±10%
LY % 0.00–100.00 ±3.0 ±10%
MO % 0.00–100.00 ±3.0 ±10%
EO % 0.00–100.00 ±1.0 ±10%
BA % 0.00–100.00 ±1.0 ±10%

When specimens covering the measuring range with no System messages are analyzed by the DxH
800 and a predicate device, the DxH 800 meets specification if the results are within the difference
defined in Table 1.3.

Table 1.3 Accuracy Specifications (DxH vs. Predicate), Whole Blood - Differential

Parameter Units Measuring Range Difference


(whichever is greater)
NE % 0.00–100.00 ±2.0 ±10%
LY % 0.00–100.00 ±1.5 ±10%
MO % 0.00–100.00 ±1.0 ±10%
EO % 0.00–100.00 ±0.5 ±10%
BA % 0.00–100.00 ±0.5 ±10%

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Performance Specifications and Characteristics 1

Reticulocyte
Accuracy for the Reticulocyte parameters is assessed by comparison of results from the DxH 800 and
a predicate instrument. Estimation of difference is determined using CLSI EP09-A2. The DxH 800
meets specification if results meet the limits defined in the table below.

Table 1.4 Accuracy Specification, Whole Blood - Reticulocytes

Parameter Units Measuring Range Difference


RET % 0.000–30.000 ±0.5 or ±10% (whichever is greater)
IRF — 0.000–1.000 ±0.2
MRV fL 50.00–190.00 ±15.0

NRBC
Accuracy for the NRBC parameter is assessed by comparison of the results from the DxH 800 and a
manual count. When specimens covering the measuring range without System messages are
analyzed by both the DxH 800 and by manual methods as described by CLSI H20-A2 Reference
Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods, the DxH 800
meets specification if the results are within limits defined in the table below.

Table 1.5 Accuracy Specifications, Whole Blood -NRBC

Parameter Units Measuring Range Correlation


Coefficient
NRBC per 100 WBC 0.00 to 600.00 r ≥ 0.90

Body Fluids
Accuracy for body fluid parameters is assessed by comparison of the results from the DxH 800 and
manual counts. The estimation of the bias is determined as described in CLSI EP09-A2 Method
Comparison and Bias Estimation Using Patient Samples. When specimens covering the measuring
range without System messages are analyzed by both the DxH 800 and by the manual method, the
DxH 800 meets specification if the results are within the limits defined in the table below.

Table 1.6 Accuracy Specifications - Body Fluids

Parameter Units Measuring Range Bias (whichever is greater)


TNC cells/mm3 20–89,000 ±5 or ±10%
RBC cells/mm3 10,000–6,200,000 ±500 or ±5.0%

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System Overview
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Repeatability

Table 1.7 Repeatability - Whole Blood CBC, DIFF, Retic (N=10)

Parameter Units Range Limit


WBC x103/μL 0.500−2.000 ≤5.0% CV
5.000–10.000 ≤3.0% CV
RBC x106/μL 4.5 to 5.5 ≤1.5% CV
HGB g/dL 14 to 16 ≤1.5% CV
MCV fL 80 to 90 ≤1.0% CV
RDW % 12 to 14 ≤2.5% CV
RDW-SD fL 33.00 to 48.00 ≤2.5% CV
PLT x103 /μL 10.0 to 15.0 ≤12.0% CV
200 to 400 ≤3.5% CV
MPV fL 8 to 10 ≤2.5% CV
NE % 50 to 60 ≤3.5% CV
LY % 25 to 35 ≤5% CV
MO % 5 to 10 ≤10.0% CV
EO % 2 to 5 SD ≤ 0.5 or
≤13.5% CV
BA % 0.5 to 1.5 SD ≤ 0.5
NRBC /100 WBC 1.00−2.00 SD ≤ 0.3
>2.00−15.00 ≤20% CV
>15.00 ≤15% CV
RET % 0.000 to 1.500 SD ≤ 0.25
>1.500 to 4.000 SD ≤ 0.70
>4.000 to 15.000 ≤7% CV
IRF — RBC ≥3.0 x 106 μL and ≤20% CV
RETIC 1.0–4.0% and
IRF ≥0.2
MRV fL 100.0–120.0 ≤5% CV

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Performance Specifications and Characteristics 1

Table 1.8 Repeatability - Prediluted Blood (N=10)

Parameter Units Range Limit


WBC x103/μL 5.000–10.000 ≤6.0% CV
RBC x106/μL 4.5 to 5.5 ≤3.0% CV
HGB g/dL 14 to 16 ≤3.0% CV
PLT x103/μL 200 to 400 ≤7.0% CV

Table 1.9 Repeatability - CSF, Serous or Synovial Body Fluid Count (N=10)

Parameter Unit Repeatability Limit


RBC cells/mm3 10,000 – 15, 000 ≤10.0% CV
TNC cells/mm3 50 – 2000 ≤15.0% CV

Measuring and Operating Ranges


Measuring Range

Measuring range is the range of values over which the acceptability criteria for the method are
defined. Measuring range can be assessed using commercially available materials qualified for use
on the DxH 800 System.

Operating Ranges
Operating range is the range over which the system, inclusive of the pre-dilute functionality, will
report (display, print and/or transmit) results. Values that are between the Measuring range and
Operating range are flagged.

Linearity

Linearity can be assessed by testing levels of an analyte that are known by formulation or by using
commercially available materials qualified for use on the DxH 800 System.

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System Overview
Performance Specifications and Characteristics

Table 1.10 Whole Blood Measuring and Operating Ranges

Parameter Units Measuring Range Operating Range Linearity (r2)


UWBC * 103/μL 0.000–400.000 0.000–999.999 N/A
WBC * 103/μL 0.000–400.000 0.000–999.999 >0.95
RBC 106/μL 0.000–8.500 0.000–10.000 >0.95
HGB g/dL 0.00–25.50 0.00–30.00 >0.95
HCT % N/A 0.00–70.00 N/A
MCV fL 50.00–150.00 40.00–200.00 N/A
MCH pg N/A 0.00–99.99 N/A
MCHC g/dL N/A 0.00–99.99 N/A
RDW % 10.00–40.00 0.00–70.00 N/A
RDW-SD fL 15.00–220.00 0.00–340.00 N/A
PLT 103/μL 0.0–3000.0 0.0–7000.0 >0.95
MPV fL 5.00–25.00 0.00–25.00 N/A
NE % 0.00–100.00 0.00–100.00 N/A
NE# 103/μL 0.000–400.000 0.000–600.000 N/A
LY % 0.00–100.00 0.00–100.00 N/A
LY# 103/μL 0.000–400.000 0.000–600.000 N/A
MO % 0.00–100.00 0.00–100.00 N/A
MO# 103/μL 0.000–400.000 0.000–600.000 N/A
EO % 0.00–100.00 0.00–100.00 N/A
EO# 103/μL 0.000–400.000 0.000–600.000 N/A
BA % 0.00–100.00 0.00–100.00 N/A
BA # 103/μL 0.000–400.000 0.000–600.000 N/A
NRBC /100 WBC 0.00–600.00 0.00–600.00 N/A
NRBC# 103/μL N/A 0.000–600.000 N/A
RET % 0.000–30.000 0.000–50.000 N/A
RET# 106/μL 0.00000–1.00000 0.00000–2.50000 N/A
IRF — 0.000–1.000 0.000–1.000 N/A
MRV fL 50.00–190.00 0.00–500.00 N/A

* Operating range achieved when using predilute capability.

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System Overview
Performance Specifications and Characteristics 1

Table 1.11 Body Fluids (CSF, Serous, Synovial) Measuring and Operating Ranges

Units Measuring Range Operating Range


RBC cells/mm3 10,000–6,200,000 0–10,000,000
TNC cells/mm3 20–89,000 0–600,000

Beckman Coulter recommends that a diluent be run as a Body Fluid sample prior to analysis of Body
Fluid specimens. Backgrounds within specifications can influence the reported results on the
samples with low abnormal or normal values. Beckman Coulter recommends that each laboratory
establish criteria for evaluation of the impact on the background on the reported results.

Carryover
Carryover results should not exceed the following limits:

Table 1.12 High to Low Carryover

Parameter Limit
WBC ≤0.5%
RBC ≤0.5%
HGB ≤1.0%
PLT ≤1.0%
NRBC ≤75 events
DIFF ≤200 events
RET ≤600 events

CBC High to Low Carryover is measured per ICSH guidelines4, and calculated as follows:

Carryover = [(1st Diluent - 3rd Diluent) / (3rd Sample - 3rd Diluent)] x 100.

For DIFF, Retic, and NRBC the counts for each diluent will be within limits as stated in Table 1.12.

High to Low Carryover for Body Fluids is measured by analyzing a whole blood specimen followed
by a diluent analyzed as a body fluid. The diluent sample should not exceed the Background limits
as stated in Table 1.14.

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System Overview
Performance Specifications and Characteristics

Background Counts
The following tables list the acceptable background limits for Daily Checks and Body Fluids.

Table 1.13 Background - Daily Checks

Parameter Limit
WBC ≤0.05 x 103/μL
RBC ≤0.005 x 106/μL
HGB ≤0.1 g/dL
PLT ≤3 x 103/μL
NRBC Region ≤10 events
NRBC Total ≤60 events
DIFF ≤100 events
RET ≤600 events

Table 1.14 Background - Body Fluids*

Parameter Limit
TNC ≤20 cells/mm3
RBC ≤1000 cells/mm3

* Analyzed by running a diluent using the Body Fluid Count cycle.

Throughput
The DxH 800 achieves the average throughput defined in the table below, when used in a routine
laboratory environment with whole blood samples having hematology parameters with the values
defined below. Throughput is achieved when cellular concentrations are in the following ranges:
WBC = 7.00–10.0 x 103/μL, RBC = 4.00–5.00 x 106/μL, PLT = 250–400 x 103/μL.

Table 1.15 Throughput per Test Panel Mode

Test Panel Specimens per Hour


CBC ≥100
CBC and Differential ≥100
CBC and Differential with NRBC ≥90
Any Retic cycle ≥45
Mixed Samples
80% CBC/Diff with NRBC ≥72
20% CBC/Diff/Retic with NRBC

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System Overview
Performance Specifications and Characteristics 1

Reference Range Studies


A Normal Range study was conducted to assess the Reference Ranges for the DxH 800. Whole-blood
samples were collected from approximately 240 donors (males and females). The selection of donors
was consistent with guidelines stated in CLSI, C28-A2. These ranges are used as the System Manager
default normal range flags. your patient population ranges may be different.

Table 1.16 Whole Blood Reference Ranges Overall

Parameter Units Overall

Mean 95% Confidence 95% Confidence


Low Limit High Limit

WBC x103/μl 6.3 3.6 11.2


RBC x106/μl 4.52 3.73 5.50
HGB g/dl 13.4 11.4 15.9
HCT % 39.0 33.3 45.7
MCV fL 86.4 73.7 95.5
MCH pg 29.6 24.3 33.2
MCHC g/dl 34.2 32.5 35.8
RDW % 13.8 12.3 17.0
RDW-SD fL 41.4 37.1 47.8
PLT x103/μl 257 159 386
MPV fL 9.2 7.5 11.2
NE % 58.5 43.3 76.6
LY % 29.6 16.0 43.5
MO % 8.3 4.5 12.5
EO % 2.8 0.6 7.9
BA % 0.7 0.2 1.4
NE# x103/μl 3.7 1.8 7.8
LY# x103/μl 1.8 1.0 3.0
MO# x103/μl 0.5 0.3 1.0
EO# x103/μl 0.2 0.0 0.5
BA# x103/μl 0.0 0.0 0.1
NRBC /100 WBC 0.1 0.0 0.4
NRBC# x103/μl 0.01 0.00 0.02
RET % 1.10 0.50 2.17
RET# x106/μl 0.0498 0.0221 0.0963
MRV fL 108.8 97.4 120.2
IRF — 0.40 0.29 0.53

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System Overview
Performance Specifications and Characteristics

Table 1.17 Whole Blood Reference Ranges Male

Parameter Units Male

Mean 95% Confidence 95% Confidence


Low Limit High Limit
WBC x103/μl 5.9 3.6 10.2
RBC x106/μl 4.81 4.06 5.63
HGB g/dl 14.2 12.5 16.3
HCT % 41.3 36.7 47.1
MCV fL 86.1 73.0 96.2
MCH pg 29.6 23.8 33.4
MCHC g/dl 34.4 32.5 36.3
RDW % 13.6 12.1 16.2
RDW-SD fL 40.8 36.5 45.9
PLT x103/μl 234 152 348
MPV fL 9.2 7.4 11.4
NE % 57.3 43.5 73.5
LY % 29.8 15.2 43.3
MO % 9.0 5.5 13.7
EO % 3.2 0.8 8.1
BA % 0.7 0.2 1.5
NE# x103/μl 3.4 1.7 7.6
LY# x103/μl 1.7 1.0 3.2
MO# x103/μl 0.5 0.3 1.1
EO# x103/μl 0.2 0.0 0.5
BA# x103/μl 0.0 0.0 0.1
NRBC /100 WBC 0.2 0.0 0.6
NRBC# x103/μl 0.01 0.00 0.02
RET % 1.09 0.42 2.23
RET# x106/μl 0.0523 0.0188 0.1086
MRV fL 109.5 97.5 122.7
IRF — 0.41 0.30 0.54

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System Overview
Performance Specifications and Characteristics 1

Table 1.18 Whole Blood Reference Ranges Female

Parameter Units Female

Mean 95% Confidence 95% Confidence


Low Limit High Limit
WBC x103/μl 6.7 3.8 11.8
RBC x106/μl 4.26 3.63 4.92
HGB g/dl 12.6 10.9 14.3
HCT % 36.9 31.2 41.9
MCV fL 86.8 75.5 95.3
MCH pg 29.6 24.7 32.8
MCHC g/dl 34.1 32.3 35.6
RDW % 14.0 12.3 17.7
RDW-SD fL 42.0 37.6 50.3
PLT x103/μl 278 179 408
MPV fL 9.2 7.9 10.8
NE % 59.7 42.7 76.8
LY % 29.4 16.0 45.9
MO % 7.6 4.3 10.9
EO % 2.4 0.5 7.0
BA % 0.7 0.2 1.3
NE# x103/μl 4.1 1.9 8.2
LY# x103/μl 1.9 1.1 3.1
MO# x103/μl 0.5 0.2 0.9
EO# x103/μl 0.2 0.0 0.5
BA# x103/μl 0.0 0.0 0.1
NRBC /100 WBC 0.1 0.0 0.3
NRBC# x103/μl 0.01 0.00 0.02
RET % 1.11 0.51 2.17
RET# x106/μl 0.0474 0.0230 0.0935
MRV fL 108.1 96.4 118.0
IRF — 0.40 0.26 0.52

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System Overview
Performance Specifications and Characteristics

Body Fluids Reference Ranges


Reportable body fluid results obtained from the DxH 800 System may exceed commonly accepted
normal reference ranges for all body fluids. Results should always be interpreted in light of the total
clinical presentation of the patient, including clinical history, data from additional tests, and other
appropriate information.

Cerebrospinal Fluid
The inability to collect cerebrospinal fluid specimen in the normal, non-diseased population limits
the ability to determine reference ranges. Literature1 suggests the following normal reference
ranges.

• WBC 0–5 cells/mm3 in adults


• WBC 0–30 cells/mm3 in children 1 to 4 years of age
• WBC 0–20 cells/mm3 in children 5 years of age to puberty
• RBC none to few

Serous Fluids
The accumulation of fluid in a serous cavity is an indication of a disease state. The normal, non-
diseased population has no fluid accumulation. Therefore, there are no normal reference ranges for
serous fluids. However, the number of cells present in a serous fluid are used to aid in the
classification, diagnosis and treatment of disease.1

Synovial Fluid
The inability to collect synovial fluid specimens in the normal, non-diseased population limits the
ability to determine reference ranges. Literature suggests the following normal reference ranges.

• WBC 0–150 cells/mm3


• RBC none

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System Overview
Performance Specifications and Characteristics 1

Sample Stability and Storage


IMPORTANT Refer to CLSI H18-A3, Procedures for the Handling and Processing of Blood Specimens for
guidelines.

Overview
The following types of sample can be analyzed on the SPM.

• Anti-coagulated human whole blood in K2 or K3 EDTA


• Prediluted anti-coagulated human blood in K2 or K3 EDTA
• Human Cerebrospinal fluid (CSF)
• Human Synovial fluid in K2 or K3 EDTA or Heparin (pretreated with Hyaluronidase)
• Human Serous fluids in K2 or K3 EDTA

Sample stability is measured by the ability of results to be within the stated specifications for a
given period of time and storage condition. A minimum of ten (10) samples are analyzed in
duplicate at time zero and the room temperature defined in Table 1.19. The mean of those results is
compared to the mean of the same samples analyzed at the times and storage conditions noted in
those tables. The difference in mean results will be within the stability ranges defined in Table 1.19
and 1.20.

Beckman Coulter recommends analyzing all non-refrigerated whole blood samples within 24 hours.

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System Overview
Performance Specifications and Characteristics

Whole Blood

Long term stability is determined by comparing results from the initial analysis (within two hours
of collection) to results from samples stored at controlled room temperature for 24 hours and
refrigerated temperature for 48 hours. Upon removal from refrigerated storage, samples were hand
mixed by inversion 20 times, allowed to warm at room temperature for a minimum of 30 minutes
and then hand mixed by inversion 20 times prior to analysis.

Table 1.19 Sample Stability (Whole Blood)

Parameter Stability At Controlled At


Range Room Refrigerated
Temperature Temperature
(18 to 26°C or (2 to 8°C or
64 to 79°F) 35.6 to 46.4°F)
Time Time

WBC (x103/μL) ≤0.5 24 hours 48 hours

RBC (x106/μL) ≤0.10 24 hours 48 hours


HGB (g/dL) ≤0.2 24 hours 48 hours
MCV fL ≤3.0 24 hours 48 hours
RDW (%) ≤1.0 24 hours 48 hours
RDW-SD ≤5.0 24 hours 48 hours
PLT (x103/μL) ≤30 24 hours 48 hours
MPV fL ≤1.0 24 hours 48 hours
NE (%) ≤5.0 24 hours 48 hours
LY (%) ≤4.0 24 hours 48 hours
MO (%) ≤3.0 24 hours 48 hours
EO (%) ≤1.5 24 hours 48 hours
BA (%) ≤1.5 24 hours 48 hours
NRBC (%) ≤0.5 24 hours 24 hours
RET (%) ≤0.30 24 hours 72 hours
MRV fL ≤4.0 24 hours 72 hours
IRF ≤0.30 24 hours 72 hours

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System Overview
Performance Specifications and Characteristics 1

Predilute

Results from prediluted samples analyzed between 5 minutes and 1 hour after preparation and
compared to those same samples from whole blood analyses should agree within the limits in
Table 1.20.

Table 1.20 Sample Stability (Pre-diluted Whole Blood)

Parameter Difference
(whichever is greater)

WBC x 103μL ±0.4 or ±10%

RBC x 106μL ±0.1 or ±4%


HGB g/dL ±0.4 or ±6%
PLT x 103μL ±10.0 or ±15%

Body Fluids
Per established literature, Body Fluid samples should be stored at room temperature and analyzed
within 1 hour of collection.

Clinical Sensitivity and Specificity Performance Characteristics


Clinical sensitivity and specificity of WBC differential flagging performance can be influenced by a
number of factors relating to instrument technology, cellular frequency, uncertainty in the
reference determination of a “positive,” and the sample population evaluated. The DxH 800 provides
the ability to set the levels and sensitivities of a variety of Flags and Messages to meet individual
laboratory requirements.

Beckman Coulter, Inc. recommends completion of sensitivity and specificity studies using your
sample population to establish these settings.

Specimen Tubes
The DxH 800 is capable of processing a wide variety of specimen tubes. Please refer to the tube list
at www.beckmancoulter.com for additional information.

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System Overview
Performance Specifications and Characteristics

Venous and Capillary Sample Performance Characteristics


Twenty-nine specimens from normal Beckman Coulter in-house donors were collected as whole
blood venous and whole blood capillary specimens. When analyzed on the DxH 800, a number of
specimens did not provide parameter results and were excluded from the analysis. The results of the
study are shown below.

Table 1.21 Venous and Capillary Sample Performance Characteristics

Mean

Parameter n Correlation Intercept Slope Venous Capillary Units


WBC 29 0.963 0.573 0.978 6.28 6.71 x103/μL
RBC 29 0.940 0.324 0.972 4.75 4.94 x106/μL
HGB 29 0.917 1.849 0.908 14.26 14.80 g/dL
MCV 29 0.994 -0.852 0.995 87.43 86.15 fL
PLT 29 0.936 -34.627 1.047 247.37 224.48 x103/μL
MPV 29 0.944 1.478 0.891 8.59 9.13 fL
RDW 29 0.960 -0.169 1.010 13.27 13.23 CV%
RDW-SD 29 0.964 -5.252 1.113 40.72 40.05 fL

NE% 25 0.978 0.995 0.966 56.65 55.58 %


LY% 25 0.974 1.488 0.968 30.75 31.46 %
MO% 25 0.949 1.573 0.864 9.11 9.38 %
EO% 25 0.979 0.039 0.992 2.78 2.81 %
BA% 25 0.333 0.551 0.309 0.70 0.77 %
NRBC% 27 0.567 0.045 0.30 0.10 0.09 %

RET% 25 0.954 0.078 0.856 1.44 1.34 %


MRV 28 0.898 24.299 0.784 107.13 108.29 fL
IRF 28 0.790 0.078 0.831 0.34 0.36 —

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System Overview
Performance Specifications and Characteristics 1

Closed and Open Vial Performance Characteristics


Twenty-five specimens from normal Beckman Coulter in-house donors were collected and analyzed
as closed vial and open vial specimens. The results of the study are shown below.

Table 1.22 Closed and Open Vial Performance Characteristics

Mean

Parameter n Correlation Intercept Slope Closed Open Units


Vial Vial
WBC 25 0.9982 0.135 0.974 6.435 6.404 x103/μL
RBC 25 0.9936 0.136 0.973 4.83 4.84 x106/μL
HGB 25 0.9912 1.213 0.985 13.72 13.73 g/dL
MCV 25 0.9927 2.152 0.974 85.29 85.22 fL
PLT 25 0.9906 -0.288 1.011 265.03 267.81 x103/μL
MPV 25 0.9913 0.671 0.919 8.53 8.51 fL
RDW 25 0.9344 1.568 0.879 13.82 13.72 CV%
RDW-SD 25 0.8766 10.782 0.731 41.58 41.16 fL
NE% 25 0.9877 -0.837 1.019 59.27 59.53 %
LY% 25 0.9809 -1.013 1.031 29.54 29.44 %
MO% 25 0.8794 0.530 0.923 8.02 7.93 %
EO% 25 0.9756 -0.073 1.022 2.49 2.48 %
BA% 25 0.7909 0.080 0.796 0.68 0.62 %
NRBC% 25 0.8899 0.017 0.752 0.15 0.13 %
RET% 25 0.9112 0.187 0.849 1.35 1.33 %
MRV 25 0.9584 -0.467 1.009 104.32 104.75 fL
IRF 25 0.8569 0.069 0.801 0.36 0.36 —

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System Overview
Performance Specifications and Characteristics

Whole Blood and Pre-Dilute Performance Characteristics


Fifty-seven specimens were analyzed as whole blood and pre-dilute. The results of the study are
shown below.

Table 1.23 Whole Blood and Pre-Dilute Performance Characteristics

Mean

Parameter n Correlation Intercept Slope Whole Pre- Units


Blood Dilute
WBC 57 0.999 -0.341 1.079 14.856 15.690 x103/μL
RBC 57 0.999 -0.010 1.043 3.67 3.82 x106/μL
HGB 57 0.999 0.165 1.041 10.95 11.57 g/dL
MCV 57 0.996 -2.686 1.004 90.42 88.11 fL
PLT 57 0.998 3.127 1.003 281.69 285.70 x103/μL
MPV 57 0.940 0.349 0.924 8.47 8.18 fL
RDW 57 0.995 -0.625 1.005 16.86 16.31 CV%
RDW-SD 57 0.991 -1.054 0.964 52.38 49.44 fL

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System Overview
Performance Specifications and Characteristics 1

Limitations

All Specimens Misleading results can occur if the specimen is not properly collected, stored
or transported. Beckman Coulter, Inc. recommends that you follow CLSI or
equivalent procedures to ensure proper specimen collection, storage and
transport. Always follow manufacturer’s recommendations when using
microcollection devices for capillary specimen collection.

Misleading results can occur if specimens contain clots. Always use good
laboratory practices for inspecting specimens for clots and verifying results.
Misleading results can occur if the specimen is not properly mixed. Always use
good laboratory practices to ensure specimens are appropriately mixed. Do
not bypass or circumvent the automated mixing process used on the DxH 800.

NOTE When running a test panel, with NRBC analysis enabled, the
information from the NRBC analysis is used to supplement interference
detection, flagging and correction.
WBC and TNC NRBCs, giant platelets, platelet clumps, malarial parasites, precipitated
elevated proteins, cryoglobulin, microlymphoblasts, very small lymphocytes,
fragmented white cells, agglutinated white cells, lyse resistant red cells,
unlysed particles > 35 fL in size.
Elevated WBC counts may have a carryover effect on subsequent leukopenic
specimens, within the limits specified in the Carryover section.
RBC Very high WBC count, high concentration of very large platelets, auto-
agglutination.
If hemolysis is occurring in vivo, the instrument RBC may be flagged as low,
reflecting the true circulating cells. If, however, the hemolysis is in vitro, the
specimen may give falsely low RBC results. Cell counts due to in vitro
hemolysis do not represent the number of circulating red blood cells.
HGB Severe lipemia, heparin, certain unusual RBC abnormalities that resist lysing.
MCV Very high WBC count, high concentration of very large platelets, auto-
agglutination.
RDW, RDW-SD Very high WBC count, high concentration of very large platelets, auto-
agglutination
PLT Giant Platelets, platelet clumps, white cell fragments, electronic noise, very
small red cells, red cell fragments.
HCT Known interferences related to RBC and MCV.
MCH Known interferences related to HGB and RBC.
MCHC Known interferences related to HGB, RBC, and MCV.
NRBC Known interferences may be related to the following:
• lyse resistant red cells
• malarial parasites
• very small or multi-population lymphocytes
• precipitated elevated proteins

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System Overview
Performance Specifications and Characteristics

Differential Hypogranular granulocytes, agranular granulocytes, lyse resistant red cells,


very small or multi-population lymphocytes, elevated triglycerides,
precipitated elevated proteins.
A transient basophilia may be observed in samples that have been exposed to
high temperatures (~ 90°F or ~ 32°C). The temporary basophilia should resolve
after stabilization at room temperature (~ 72°F or ~ 22°C).
Reticulocytes Erythrocyte inclusions stained by New Methylene Blue, if sufficiently
numerous within a sample, and some hemoglobinopathies (SS, SC) might
affect the accuracy of the reticulocyte enumeration2.
Body Fluids • Clotted specimens may lead to misleading or erroneous results. Follow
standard operating procedure for inspecting specimens for clots.
• Improperly mixed specimens may lead to misleading or erroneous results.
• Cellular debris may lead to misleading or erroneous results.
• Results should be interpreted in light of the total clinical presentation of
the patient, including clinical history, data from additional tests, smear
review, and other appropriate information.
Cerebrospinal • The low levels of albumin and lipids in cerebrospinal fluid may accelerate
Fluid cell lysis, leading to decreased manual counts and an apparent lack of
correlation.3
• Delays in processing may lead to misleading or erroneous results.
Synovial Fluid • Fat globules may lead to misleading or erroneous results.
• Crystals may lead to misleading or erroneous results.
• Highly viscous synovial fluids may trap cells leading to misleading or
erroneous results.

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CHAPTER 2

Operation Principles

History

Coulter Principle
W.H. Coulter (1956) describes the Coulter Principle:5
A suspension of blood cells is passed thru [sic] a small orifice simultaneously with an electric current. The
individual blood cells passing through the orifice introduce an impedance change in the orifice determined
by the size of the cell. The system counts the individual cells and provides cell size distribution. The
number of cells counted per sample is approximately 100 times greater than the usual microscope count to
reduce the statistical error by a factor of approximately 10 times.

This substantial improvement in precision over previous methods helped to establish the
erythrocyte count as a sensitive index of erythropoietic dyscrasia, particularly when considered
together with Hct and Hgb measurements. 6
The COULTER COUNTER® Model S analyzer was the first instrument that automated simultaneous
multiparameter measurements on blood. Brittin et al., Gottmann, and Hamilton and Davidson,
reviewed the performance and clinical value of the Model S.7,8,9

Refinements of the COULTER COUNTER analyzer to provide accurate size (volume) distribution data
led to a reawakening of interest in pathological erythrocyte size distribution, first sparked by Price-
Jones.10,11

Among the advantages offered by the Coulter method of counting and sizing was the ability to
derive an accurate Hct measurement by summing the electronic volume of erythrocytes. England
et al. speculated that electronic Hct measurements did not contain the trapped plasma error of
centrifugal Hct measurements. 12

Bull et al. described the use of a COULTER COUNTER analyzer for counting thrombocytes.13 This
method, useful as it was, depended on preparing thrombocyte-rich plasma to avoid counting
erythrocytes as thrombocytes. Mundschenk et al. and Schulz and Thom discussed the possibility of
counting thrombocytes in the presence of erythrocytes and classifying them by size.14,15 Electronic
refinements in the Model S-PLUS enhanced the accuracy of the hydrodynamic method. Von
Behrens and Paulus have also cited the feasibility of counting thrombocytes by the Coulter method.
16,17

629743AE 2-1
Operation Principles
History

Coulter Method
The Coulter Method accurately counts and sizes cells by detecting and measuring changes in
electrical resistance when a particle (such as a cell) in a conductive liquid passes through a small
aperture. See Figure 2.1, Coulter Method.

Figure 2.1 Coulter Method


VACUUM

APERTURE INTERNAL
CURRENT ELECTRODE

EXTERNAL
ELECTRODE

DETAIL OF
SAMPLE BLOOD APERTURE
BEAKER CELL
SUSPENSION

APERTURE
APERTURE TUBE 7016004B

Each cell suspended in a conductive liquid (diluent) acts as an insulator. As each cell goes through
the aperture, it momentarily increases the resistance of the electrical path between the submerged
electrodes on either side of the aperture. This causes a measurable electronic pulse. For counting,
the vacuum used to pull the diluted suspension of cells through the aperture must be at a regulated
volume.18,19,20,21

While the number of pulses indicates particle count, the size of the electrical pulse is proportional
to the cell volume.

VCS Technology
The COULTER VCS established WBC differential technology using three measurements: individual
cell volume, high-frequency conductivity and laser-light scatter.

The combination of low-frequency current, high-frequency current and light-scattering


technology provided abundant cell-by-cell information that is translated by the SPM into dataplots.

Volume Analysis

Electronic Leukocyte Volume Analysis using low-frequency current, has been used since 1967.22 It
has been evaluated as a possible adjunct to the differential white cell count.23, 24, 25, 26

Conductivity Analysis

Cell walls act as conductors to high frequency current. The current, while passing through the cell
walls and through each cell interior, detects differences in the insulating properties of the cell

2-2 629743AE
Operation Principles
History 2

components. The current characterizes the nuclear and granular constituents and the chemical
composition of the cell interior.27, 28, 29

Light Scatter Analysis

Coulter’s experience in flow cytometry dates back decades to Fulwyler’s pioneering use of light
scatter for cell analysis. Loken et al. and Jovin et al. discuss the relationship of particle size and
refractivity to the angle of light scattered from a laser beam.30, 31, 32

TTM
Historically, Beckman Coulter analyzers housed a flow cell in a Triple Transducer Module (TTM),
first introduced commercially in the 1980’s. The TTM flow cell was the location for detection of the
processed samples. The TTM produced three measurement signals – volume, conductivity and light
scatter.
The DxH 800 replaces the TTM with the Multi-transducer Module (MTM), which measures
additional multiple angles of light scatter, a major improvement over the single light scatter
measured by the TTM.

Reticulocyte Analysis
Reticulocytes are immature, non-nucleated erythrocytes retaining a small network of basophilic
organelles, consisting of RNA and protoporphyrin. The enumeration of reticulocytes provides a
simple, effective means to determine red cell production and regeneration.33, 34, 35, 36

The most common means of measuring reticulocytes is to use supravital dyes, such as New
Methylene Blue or Brilliant Cresyl Blue. These dyes precipitate and aggregate the basophilic
substances within the reticulocyte, resulting in a granular, staining pattern easily seen with light
microscopy.37

Reticulocyte immaturity is related to cell volume and light scatter. Since more immature
reticulocytes are larger, contain more RNA and cause increased light scatter, the cell volume and
light scatter will increase with immaturity of the cell.

629743AE 2-3
Operation Principles
DxH 800 Operation Principles

DxH 800 Operation Principles

CBC Analysis
In hematology, the complete blood count, the CBC, is the fundamental analytical test that evaluates
the three main cellular components: white blood cells, red blood cells and platelets. The DxH 800
CBC analysis is based on the Coulter Principle.

The sample preparation and data collection occurs in the SAM and CBC modules and analysis is
handled by the System Manager.

Specimen Preparation
The aspiration pump activates and aspirates 165 μL of sample. After the probe is removed from the
specimen tube a second pull of the aspiration pump draws the blood through the BSV pathway,
verifying a proper aspiration at the blood detectors.

With each cycle, the BSV directs the delivery of sample and DxH Diluent to the WBC and RBC triple
aperture baths.

The RBC diluent and WBC diluent/Lyse dilutions enter through a port in the bath that is located at
the bottom and tangential to a sloping surface for bubble free delivery and mixing.

In the WBC bath, ~6.0 mL of DxH diluent and ~28 μL of sample are combined with ~1.08 mL of DxH
Cell Lyse for a final dilution of 1:251. In the RBC bath, ~10 mL of DxH diluent and ~1.6 μL of sample
are combined for a final dilution of 1:6250.

Figure 2.2 Tangential Mixing

2-4 629743AE
Operation Principles
DxH 800 Operation Principles 2

Detection/Sensing
After the mixing and incubation of sample and reagents, 6 inches of vacuum and aperture current
are applied to the apertures simultaneously for the measurements of cell count and cell volume.
The RBC and PLT count includes the application of sweep flow to prevent the recirculation of cells
behind the aperture. All pulses generated by the apertures are collected and sent to the Signal
Conditioner Analyzer Card for analog to digital conversion. The process provides the following raw
counts and digital measurements to the System Manager:
• Time
• Volume (pulse peak amplitude)
• Count rate
• Wait time
• Pulse width
The System Manager processes the measurements. The process includes:

• Coincidence correction
• Voting
• The generation of 256 channel histograms for WBC, RBC, and PLT and their voting pattern
analysis
• Interference correction

Pulse Editing

When cells pass through the aperture near the edge or at an angle rather than at the center, they
create atypical pulses. These atypical pulses are excluded from analysis because they distort the
true size of the cell. This prevents the atypical pulses from influencing size measurement.

Sweep Flow

The sweep flow is a steady stream of diluent that flows behind the RBC aperture during the sensing
period. This prevents cells from re-entering the sensing zone and being counted as platelets. See
Figure 2.3.

629743AE 2-5
Operation Principles
DxH 800 Operation Principles

Figure 2.3 Sweep Flow


A B

2 2
1
1

Example A: No Sweep Flow Example B: Sweep Flow Added

1. Sensing Zone 1. Sensing Zone


2. Cell Recirculates 2. Cell Carried to Waste
3. Sweep Flow

Counting/Sizing

The RBC and WBC baths each have three discrete apertures that function as independent systems,
utilizing the Coulter Method to accurately count and size cells.

Coincidence Correction

Occasionally, more than one cell passes through the aperture at one time. When cells coincide, the
SPM counts only one pulse. As the frequency of coincidence is proportional to the actual count, the
system automatically corrects results for coincidence.

Scaling

Scaling adjusts for calibration and reportable format.

Voting and Averaging

To prevent data errors due to statistical outliers or obstructions that may block an aperture, the
SPM votes on the data from all of the apertures, and rejects any questionable data. For the WBC,
RBC, MCV, RDW, Plt, and MPV, the SPM compares the data from the three apertures. It verifies that
at least two apertures have produced data within an established statistical range of each other.

When a parameter totally votes out, the system does not give any results for the affected parameter
or for any parameters that are derived from it. See Flags and Codes in the Data Review chapter of
this manual for codes and messages that appear in these circumstances.

2-6 629743AE
Operation Principles
DxH 800 Operation Principles 2

Hemoglobinometry
The lytic reagent used for the WBC prepares the blood so the system can count leukocytes and
measure the amount of hemoglobin. The lytic reagent rapidly and simultaneously destroys the
erythrocytes and converts a substantial proportion of the hemoglobin to a stable pigment while it
leaves leukocyte nuclei intact. The absorbance of the pigment is directly proportional to the
hemoglobin concentration of the sample.

The accuracy of this method equals that of the hemiglobincyanide method, the reference method
of choice for hemoglobinometry recommended by the International Committee for
Standardization in Hematology.38
After the WBC are counted, the lysed WBC dilution drains into the hemoglobin cuvette for Hgb
measurement. Hgb is measured photometrically at 525 nm using the sample from the WBC analysis.
A blank is introduced into the cuvette during each operating cycle. The Hgb blank provides a
reference to which the sample signal is compared.

Generation of Histograms
The digital information from each aperture is stored according to volume in 256-channel, size
distribution histograms.
To ensure that the size-distribution curves accurately reflect the true cell population, the sensing
may be extended whenever the data accumulations are below a predetermined value.

629743AE 2-7
Operation Principles
VCSn

VCSn

All Diff, NRBC, and Retic analysis occurs in the VCSn module. The VCSn module is responsible for
controlled sample preparation and delivery of the prepared sample to the flow cell for analysis of
the WBC differential, reticulocytes and NRBC. The VCSn module includes the Air Mix and
Temperature Control (AMTC) Module and the Multi-transducer Module (MTM).

Sample Preparation
The sample preparation for Diff, NRBC, and Retic analysis occurs in the mix chambers in the AMTC
module of the VCSn module. The blood samples used for analysis are delivered by the SAM and
dispensed directly to the appropriate mix chamber. Next, the temperature-controlled reagents are
delivered and the sample and reagents are mixed using a focused jet of air regulated to 4 psi. The
mix chambers, reagents and air are all temperature controlled.

Detection/Sensing
Once the sample is prepared, the sample is delivered via the Distribution Valve (DV) to the MTM for
sample detection.

MTM
The MTM measures particle light scatter by utilizing a flow cell to pass particles through a sensing
zone one cell at a time. Figure 2.4 shows the MTM without its protective housing to display the laser
and flow cell and label locations. As the particles pass through the sensing zone, a diode laser
illuminates the particles. The MTM flow cell measures volume, conductivity, multiple angles of
light scatter and axial light loss.

2-8 629743AE
Operation Principles
VCSn 2

Figure 2.4 Multi-Transducer Module with Protective Housing Cut Away


AVOID EXPOSURE AVOID EXPOSURE
LASER RADIATION IS LASER RADIATION IS
EMITTED FROM THIS APERTURE EMITTED FROM THIS APERTURE

AVOID EXPOSURE TO BEAM AVOID EXPOSURE TO BEAM


CLASS 3B LASER PRODUCT CLASS 3B LASER EMISSION
IEC 60825-1 IEC 60825-1 :2001-8

COHERENT® COHERENT®
27650 SW 95th AVENUE
12840 BILL CLARK WAY
WILSONVILLE, OR 97070
AUBURN, CA 95602-9595
USA (530) (800) 367-7890
USA (530) (800) 367-7890
MFG DATE: XXXXXXX
MFG DATE: XXXXXXX
PN: xxxxxxx REV: xx
xxxxxxx REV. xx
SN: xxxxxx
1 2

4 5
S/N xxxxxx
OEM - Class 3b product OEM - CLASS IIIb product
0004
1

00041

DOES NOT COMPLY WITH CDRH


00042

does not comply with CDRH


00043
00044 A
00045

21CFR 1040.10 and 1040.11


21CFR 1040.10 and 1040.11

CC

Volume and Conductivity


In the flow cell, low-frequency, direct current measures volume, while high-frequency (RF) current
senses cellular internal content through measuring changes in conductivity.

Measuring Light Scatter and Axial Light Loss


The MTM utilizes a flow cell to pass particles through a sensing zone one particle at a time and a
diode laser to illuminate the particles. The illuminated particles both scatter and absorb a portion
of the incident light.

Sensors strategically placed around the flow cell collect the scattered light of interest.

An additional sensor placed in the laser path measures the amount of light removed due to light
scatter and absorption. This measurement is called Axial Light Loss.

629743AE 2-9
Operation Principles
VCSn

Figure 2.5 Light Scatter on the DxH 800

1. Lower Electrode (DC and RF)


2. Upper Electrode (DC and RF)
3. Axial Light Loss (ALL) 0°
4. Low Angle Light Scatter (LALS) 5.1°
5. Lower Median Angle Light Scatter (LMALS) 10°–20°
6. Upper Median Angle Light Scatter (UMALS) 20°–42°
7. The fifth light scatter channel is the sum of the UMALS and the LMALS regions (called MALS).

2-10 629743AE
Operation Principles
VCSn 2

Dataplot Development
The System Manager performs a series of operations on the stored digital raw values received from
the flow cell to identify populations and calculate the frequency of cells within each population. The
system produces the Dataplot displays for visual representation of the Differential, NRBC and
Reticulocyte membership and density.

The DxH 800 System algorithm uses tools designed for finding optimal separation between
overlapping clusters of data. The algorithm can

• adapt to unusual population shifts and overlaps


• define highly irregular separation
• make subsequent analysis of the identified regions
• correct deficiencies in separation

In the Dataplots, different colors represent different memberships (types of cells). Shades of colors
represent density (concentration): dark colors for low density, bright colors for high density.

NRBC Analysis Diff Analysis Retic Analysis

NRBC Red Lymphocyte Blue WBC Blue


Other* Green Monocyte Green RBC Red
WBC Blue Neutrophil Purple PLT Green
Eosinophil Orange RETIC Purple
Basophil White
Non-White Cell Red

*Others include RBC debris, and PLT debris, etc.

629743AE 2-11
Operation Principles
VCSn

Two-Dimensional (2-D) Dataplots


DIFF

The 2-D, 5 Part Diff (5PD) Dataplot shows the five main populations: lymphocytes (LY), monocytes
(MO), neutrophils (NE), eosinophils (EO) and basophils (BA), plus the non-white cell populations. For
the 5PD1 Dataplot, Volume (V), is plotted on the Y-axis; Rotated Light Scatter (RLSn) is plotted on
the X-axis. The 5PD2 dataplot shows Volume (V) on the Y-axis and Opacity (OP) on the X-axis.

NRBC

The NRBC Dataplot shows two main populations: NRBC and WBC. On the NRBC1 Dataplot, Axial
Light Loss (AL2) is shown on the X-axis; Rotated Low Angle Light Scatter (RLALS) is shown on the
Y-axis. On the NRBC2 Dataplot, Rotated Upper Medium Angle Light Scatter (RUMALS) is shown on
the Y-axis. while Axial Light Loss (AL2) is shown on the X-axis

RETIC

The Reticulocyte Dataplot shows mature red cells and Reticulocytes. On the RETIC1 Dataplot, cell
volume (V) is plotted on the Y-axis, and Linear Light Scatter (LLSn) is plotted on the X-axis. On the
RETIC2 Dataplot, Opacity (OP) is plotted on the X-axis while Volume (V) is shown on the Y-axis.

Three-Dimensional (3-D) Dataplots


The 3-D Dataplot view classifies by density, light scatter and opacity. The axes are color coded.

DIFF

On the Differential Dataplot (3-D Cube or the DIFF) the axes are:

Volume = green
RLS (Rotated Light Scatter) = red
OP (Opacity) = blue

NRBC

On the NRBC 3-D Dataplot (3-D Cube for NRBC), the axes are:

Volume = green
RLS (Rotated Light Scatter) = red
OP (Opacity) = blue

RETIC

On the RETIC Dataplot(3-D Cube for RETIC) the axes are:


Volume = green
LLS (Log of Light Scatter) = red
OP (Opacity) = blue

2-12 629743AE
Operation Principles
VCSn 2

Surface Plots
Surface plots (See Figure 6.20) show the same populations as the 2-D Dataplots, with the addition of
density in the Z direction (for example, peak height):

5PD1 - RLSn (X) versus V (Y)


5PD2 - OP (X) versus V (Y)
NRBC1 - AL2 (X) versus RLALS (Y)
NRBC2 - AL2 (X) versus RUMALS (Y)
RETIC1 - LLSn (X) versus V (Y)
RETIC2 - OP (X) versus V (Y)

629743AE 2-13
Operation Principles
Parameter Measurement, Derivation, and Calculation

Parameter Measurement, Derivation, and Calculation

Table 2.1 Parameters and their Derivation

Parameter Method Description


(Reporting
Units in US-1
Format)
WBC Coulter Principle White Blood Cell Count or Leukocyte Count
• Measured directly, multiplied by the calibration factor.
• Corrected for interference if necessary. If no correction is
required, then WBC = UWBC.
• WBC = N x 103 cells/μL
UWBC Coulter Principle Uncorrected White Blood Cell
• Measured directly, multiplied by the calibration factor.
• UWBC = N x 103 cells/μL
RBC Coulter Principle Red Blood Cell Count or Erythrocyte Count
• Measured directly, multiplied by the calibration factor
• Corrected for very high white count if necessary.
• RBC = N x 106 cells/μL
Hgb Photometric Hemoglobin or Hemoglobin Concentration
Measurement • Transmittance of light at 525 nm through a lysed WBC solution
in the Hgb cuvette, compared to the transmittance of the same
light through a reagent blank. The system converts this ratio to
the Hgb value using a calibration factor.
• Weight (mass) of Hgb determined from the degree of
absorbance found through photo current transmittance
expressed in g/dL.
• Corrected for WBC interference.
• Hgb (g/dL) = [constant X log10 (Reference %T/Sample %T)]
Hct Calculated Hematocrit
• The relative volume of packed erythocytes to whole blood
• Hct (%) = (RBC X MCV)/10
MCV Derived from RBC Mean Corpuscular Volume
Histogram • The average volume of individual erythrocytes derived from the
RBC histogram
• The system multiplies the number of RBC in each channel by the
size of the RBC in that channel. The products of each channel
between 36 and 360 femtoliters (fL) are added. This sum is
divided by the total number of RBC between 36 and 360 fL. The
Analyzer then multiplies by a calibration factor.
• Corrected for WBC interference.
• Expressed in fL.

2-14 629743AE
Operation Principles
Parameter Measurement, Derivation, and Calculation 2

Table 2.1 Parameters and their Derivation

Parameter Method Description


(Reporting
Units in US-1
Format)
MCH Calculated Mean Corpuscular Hemoglobin
• The weight of Hgb in the average erythrocyte
• MCH (pg) = (Hgb/RBC) x 10
MCHC Calculated Mean Corpuscular Hemoglobin Concentration
• The average weight of Hgb in a measured dilution
• MCHC (g/dL) = (Hgb/Hct) x 100
RDW Derived from RBC Red Cell Distribution Width
Histogram • The size distribution spread of the erythrocyte population
derived from the RBC histogram.
• Expressed as coefficient of variation (%)
RDW-SD Derived from RBC Red Cell Distribution Width - SD
Histogram • The size distribution spread of the erythrocyte population
derived from the RBC histogram
• Expressed as a standard deviation in fL
PLT Coulter Principle Platelet Count or Thrombocyte Count
• The number of platelets derived from the Plt histogram,
multiplied by a calibration factor
• Plt = N x 103 μL
MPV Derived from Plt Mean Platelet Volume
Histogram • The average volume of individual platelets derived from the Plt
histogram, multiple by a calibration factor
• Expressed in fL
NE VCSn Technology Neutrophil Percent
• [NE events/(NE+LY+MO+EO+BA events)] x 100
• Expressed as a percentage (%)
LY VCSn Technology Lymphocyte Percent
• [LY events/(NE+LY+MO+EO+BA events)] x 100
• Expressed as a percentage (%)
MO VCSn Technology Monocyte Percent
• [MO events/(NE+LY+MO+EO+BA events)] x 100
• Expressed as a percentage (%)
EO VCSn Technology Eosinophil Percent
• [EO events/NE+LY+MO+EO+BA events)] x 100
• Expressed as a percentage (%)
BA VCSn Technology Basophil Percent
• [BA events/(NE+LY+MO+EO+BA events)] x 100
• Expressed as a percentage (%)

629743AE 2-15
Operation Principles
Parameter Measurement, Derivation, and Calculation

Table 2.1 Parameters and their Derivation

Parameter Method Description


(Reporting
Units in US-1
Format)
NRBC VCSn Technology Nucleated Red Blood Cell Count
• The number of nucleated red blood cells (NRBC) per 100 WBC
• Expressed as NRBC/100 WBC
NE# Calculated Neutrophil Absolute Count
• NE# (103/μL) = (NE/100) x WBC
LY# Calculated Lymphocyte Absolute Count
• LY# (103/μL) = (LY/100) x WBC
MO# Calculated Monocyte Absolute Count
• MO# (103/μL) =(MO/100) x 100
EO# Calculated Eosinophil Absolute Count
• EO# (103/μL) = (EO/100) x WBC
BA# Calculated Basophil Absolute Count
• BA# (103/μL) = (BA/100) x WBC
NRBC# Calculated Nucleated Red Blood Cell Absolute Count
• Represents the total number of nucleated red blood cells
• NRBC (103/μL) = (NRBC/100) x WBC
RET% VCSn Technology Reticulocyte Percent
• The number of reticulocytes per 100 RBC
• Ratio of retics to the total number of red cells
• RET% = (Retic Events / Red Cell Events) x 100
RET# Calculated Reticulocyte Absolute Number
• RET# x 106/μL = (RET x RBC) / 100
IRF Calculated Immature Reticulocyte Fraction
• A percentage of the count of the highest light scatter retics (the
most immature retics) relative to the total retic count
• Expressed as a decimal ratio
• IRF = (Retic Events Regions 3-10) / (Retic Events Regions 1-10)
MRV Calculated Mean Reticulocyte Volume
• The average volume of all retic events
• MRV (fL) = (Retic Volume Regions 1-10) / (Retics Events Regions
1-10)

2-16 629743AE
Operation Principles
Quality Control Principles 2

Quality Control Principles

Overview
The purpose of Quality Control is to monitor various aspects of the SPM’s performance. Quality
Assurance includes service and maintenance as required in conjunction with the use of controls and
calibrators. The combination of these methods provides the assurance of complete quality control
and should be applied separately or in combination, in accordance with your laboratory and
accreditation requirements.

Daily Checks
Daily Checks automatically starts a series of quality control checks that will determine if the SPM is
running properly, such as Background Counts. You can review the results of the Daily Checks on the
System Manager. For additional information on doing and reviewing Daily Checks, refer to the Daily
Checks chapter.

Commercial Controls
Run commercial controls as needed to verify the performance of the SPM. Refer to Analyze
Commercial Controls in the Quality Control chapter for more information running controls.

Extended QC
Extended QC Rules are derived from the German Quality Control Guidelines for the Medical
laboratory, known in Germany as Rili-BÄK. Rili-BÄK (Guidelines of the Federal Chamber of
Physicians), was first published in 1987 and amended in 1990 and 1993 covering clinical chemistry,
immunochemistry and other tests, but not hematology. In 2003, the guidelines were extended to
include hematology and were updated in 2008.

XB Analysis
Dennis B. Dorsey MD, proposed in 1963 that the relatively constant blood cell indices could be used
to follow the performance of hematology instrumentation.39 Brian Bull, MD, improved the
technique and it is termed XB Analysis.40

XB Analysis uses a “weighted moving average ” of patient sample results because Koepke and
Protextor said that QC materials “ideally should be similar in structure and in reactivity to the
patient constituent being measured. Therefore freshly drawn patient blood samples seem to be the
most appropriate [QC material].” 41 Bull explains, “The analyzer [sic] is considered to be ‘in control’
when mean MCV, MCH, and MCHC determined on a batch of 20 patients by use of the algorithm XB
are within 3% of the expected mean indices of the population.”42

629743AE 2-17
Operation Principles
Quality Control Principles

XM
XM Analysis is a quality-control method that uses an Exponentially Weighted Moving Average
(EWMA) of CBC, Diff, NRBC and Reticulocyte Parameters and compares them with known target
values, to monitor instrument performance. The first form of moving average statistical analysis in
hematology was XB Analysis.

IQAP
The Interlaboratory Quality Assurance is a Beckman Coulter program available to you through
enrollment that complements and enhances your laboratory’s in-house quality control. IQAP allows
you to submit your control recovery data to Beckman Coulter and in return, receive a personalized
report that summarizes your results and compares them to those of your peer group (pool).

2-18 629743AE
CHAPTER 3

Daily Checks

Daily Checks (Menu > QA > Daily Checks)

Daily Checks ensure that your DxH 800 System is running correctly.

NOTE For information on Quality Control that you can perform in addition to Daily Checks, refer to the Quality
Control chapter.

Setup
Refer to Daily Checks Configuration (Daily Checks > Auto Configuration > Configure Daily checks) in
the Setup chapter for information on configuring Daily Checks.

Log on to the System Manager


Daily Checks are initiated from the System Manager.

1 Type your user name.

2 Type your password. If you forget your password, contact your laboratory administrator to
reset your password.

629743AE 3-1
Daily Checks
Daily Checks (Menu > QA > Daily Checks)

Run Daily Checks

1 Select the Daily Checks button from the top of any screen to display the Daily Checks- Summary
screen with results of the most recent Daily Checks.

Figure 3.1 Daily Checks - Summary Screen

2 Select the Daily Checks button at the bottom of the screen. A DxH 800 dialog box displays the
following: Are you sure you want to start a Daily Checks procedure? Press OK to continue.

3 Select OK to run Daily Checks,


or
Select Cancel.

3-2 629743AE
Daily Checks
Daily Checks (Menu > QA > Daily Checks) 3

Daily Checks Screen


The results of Daily Checks display on eight tabbed views: Summary (default view), System,
Background, Supplies, CBC, Diff, Retic, NRBC. When Daily Checks pass, the Daily Checks icon is
neutral. Select the individual tabs to view those results.

If any of the Daily Checks do not pass:

• the Daily Checks icon is red.


• the problematic result is backlit in red on the Summary tab.
• the tab that contains the problematic result has a red indicator.

If there are any failures, you must Review Daily Checks in order to proceed with further analysis.

Figure 3.2 Daily Checks - System Screen

629743AE 3-3
Daily Checks
Daily Checks (Menu > QA > Daily Checks)

The button options on the Local Navigation bar at the bottom of the Daily Checks screen are
described below.

Button Function
Daily Checks Runs Daily Checks
Shutdown Shuts down the SPM.
Auto Report Allows you to configure auto reporting for Daily Checks.
Auto Allows you to configure Auto Running of Daily Checks.
Configuration
Export Exports Daily Checks results to a CD-ROM or your local drive.
Review Marks Daily Checks results as reviewed.
Cancel Cancels Daily Checks.
View Log Displays the History Log screen.

3-4 629743AE
Daily Checks
Daily Checks (Menu > QA > Daily Checks) 3

DIFF, RETIC, and NRBC


Select the Histograms button at the right of the screen on the DIFF, RETIC or NRBC tabs to display
the VCSn Ramp Tests Histogram screen.

Figure 3.3 Daily Checks - NRBC Screen

629743AE 3-5
Daily Checks
Daily Checks (Menu > QA > Daily Checks)

Figure 3.4 VCSn Ramp Tests Histograms Screen

NOTE The VCSn Ramp Tests Histogram screen is not for routine use; however, you may at some time be
asked to access this screen when on the phone with your Beckman Coulter Representative.

3-6 629743AE
Daily Checks
Export Daily Checks 3

Export Daily Checks

Select the Export button on the Local Navigation Bar to export Daily Checks results to a raw data file
(INF/DAT) or a .csv file.

Figure 3.5 Export QA Data Dialog Box

1 Select the Type of file.

2 Select a Destination.

3 Select Start.

Review Daily Checks

The Daily Checks must pass or be reviewed in order to run specimens.

From any tab on the Daily Checks screen, select the Review button on the Local Navigation bar to
indicate that the Daily Checks results have been reviewed.

NOTE IF Daily Checks pass, the Review button is disabled. You only have to review results that are
questionable.

629743AE 3-7
Daily Checks
Print Daily Checks

Print Daily Checks

Select the Print icon at the top of the Daily Checks screen to manually print Daily Checks Summary
or Detail reports.

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CHAPTER 4

Quality Control

Overview

Quality Control is the routine monitoring of performance and service using commercial or
patient controls. Controls have known characteristics when run on a given system and are analyzed
periodically in the same manner that patient specimens are analyzed. The results of analyzed
controls are then compared to the known characteristics using statistical methods. This
comparison allows changes in the SPM performance to be detected. You can then take some action
if the changes detected are significant.

The DxH 800 System allows you to use multiple quality control techniques that are outlined in this
chapter. Beckman Coulter recommends that Quality Control checks be performed using patient or
commercial controls by either cassette or single-tube presentation at intervals established by your
lab. When using a commercial control, refer to the package insert to determine which method of
presentation to use. Failure to recover control values within your lab’s expected limits or the
presence of unexplained shifts or trends in any method of presentation should be investigated. If
control problems cannot be resolved, call your Beckman Coulter Representative.

Timely Quality Control monitoring includes Intelligent Quality monitoring (IQM), which monitors
event notification and recovery within the system on an on-going basis. IQM monitors sensor and
hardware status in real-time, and also provides tracking and trending of event notifications via the
Alert Status icons, alarms and the History Event Log. Events can be addressed as they occur. The
availability of IQM optimizes system availability and minimizes possible repeat patient testing for
failed QC.

NOTE For information on Beckman Coulter recommended controls, refer to Recommended Controls and
Calibrators in the System Overview chapter. For information on setting up Quality Controls and enabling
the auto configuration of controls, refer to Quality Control (Menu > Setup > Quality Control) in the Setup
chapter.

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Quality Control
Overview

When a Commercial Control is Outside its Expected Range


1. Ensure the control:
• Material was mixed properly. If not, mix it according to the package insert.
• Identification information was entered correctly. If using a bar-code reader, ensure the bar-
code labels are clean and positioned correctly. If entering the ID manually, ensure that you
typed the correct information.
• Setup information (assigned values and expected ranges) matches either the control
package insert, or your labs established values. If they do not, change the control’s
information to match.

2. If any of the problems mentioned in item 1 above existed, rerun the control; otherwise, proceed
to the next step.
3. Rerun the control to ensure the problem was not a statistical outlier.
4. Ensure the control material was not contaminated by running another vial or level of control.
5. Ensure there are no errors during the cycle. If necessary, call your Beckman Coulter
Representative.

When a COULTER LATRON CP-X Control is Outside its Expected Range


1. Ensure the control setup information (assigned values and expected ranges) matches those on
the package insert. If they do not, change the control information to match the package insert,
then rerun the control.
2. Check the control:
• Ensure the control is not contaminated, properly mixed, not expired, and you have a
sufficient volume of sample.
• If necessary, use a new vial of control. Be sure to mix it according to the directions on your
package insert.

3. Ensure the flow cell is clear by performing the Flush Flow Cell procedure.
4. Rerun the control. If the control is still outside the expected ranges, call your Beckman Coulter
Representative. You can set the SPM to CBC mode and continue to process CBC samples.

Setup Controls
Refer to the Setup chapter for information on setting up controls.

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Overview 4

Analyze Commercial Controls

1 Prepare the control according to the instructions on the package insert.

2 Follow the instructions in your package insert for running the control.

Viewing Control Files - Data View (Menu > QA > QC)


To view control files on the Quality Control (Data View) screen:

1 Select the QC Status icon at the top of any screen to display the Quality Control screen.

Figure 4.1 Quality Control (Data View) Screen

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Quality Control
Overview

Figure 4.2 Quality Control (Data View) Screen with Extended QC Enabled

The Quality Control - Data View screen displays the most recently analyzed control lot with the
most recently analyzed run selected by default. If controls have not been reviewed, a dialog box
displays a list of those controls that have not been reviewed.

The Quality Control (Data View) screen includes summary data, configuration data, a filter section,
QC run data, run status and one thumbnail Levy-Jennings Graph for the selected parameter (row).
For instructions on selecting a control, refer to Select a Control in this chapter

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Overview 4

The components on the Quality Control (Data View) screen are described below.

Component Description
Delta Diff The difference between the calculated mean and the assigned target of the parameter
within the specified filter.

NOTE If the Extended QC is enabled and Extended QC limits have been configured and
the equation below is greater than (absolute Delta Diff/BCI Target Value) x 100 is
greater than the Systematic Error limit, the Delta Diff will be highlighted in yellow for
that parameter if N>=2 and N<15 or in red if N>=15.
If the parameter’s target is not applicable, N/A displays in this field.
Mean The calculated mean of the included points within the specified filter.
2SD The calculated SD of the included points within the specified filter.
%CV The calculated Coefficient of Variation of the included points within the specified filter.

NOTE If the Extended QC is enabled and Extended QC limits have been configured and
the CV value is greater than the Random Error limit, the %CV will be highlighted in
yellow for that parameter if N>=2 and N<15, or in red if N>=15.
RMSE Root Mean Square Error displays when Extended QC is enabled. See Figure 4.2. The
RMSE is a Single Measurement Error. If the value exceeds the Single Measurement Error
limit, the RMSE value will be highlighted in yellow for that parameter if N>=2 and N<15.
The value is highlighted in red if N>=15.
If the parameter’s target is not applicable, N/A displays in this field.
N The number of included points within the specified filter.
Target The assigned target of the parameter being used in your lab at the time of the control
analysis. The target used for Extended QC will be based on what has been configured for
Traditional QC (either assigned or Mean to Target values).
If Beckman Coulter or manually-entered targets are used, then the label below this
(Assigned or heading reads “Assigned”; if means are used, then the label below the heading reads
Mean) “Mean.” If the parameter’s target is not applicable, N/A displays in this field.
Limit The traditional expected limit of the parameter in use in your lab at the time of the
control analysis.

(Manual, If assigned limits are used, then the label below this heading reads “Manual.” If SDs or
2SD, or Lab) Lab Limits are used, then the label below this heading reads “2SD” or “Lab,”
respectively.
Date/Time The date and time of the control analysis.
Exclude Allows you to exclude the results of that run from the control statistics calculations.
Reviewed By Displays one of the following:
• If the run has not yet been reviewed: A Click to Review link that allows you to review
the run.
• If the run has been reviewed: The reviewer’s username and the review date and
time.
Presentation Displays the method of presentation for each run in the control file.
• C = Cassette Presentation
• S = Single-tube Presentation

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Quality Control
Overview

Comment A comment icon displays in this column if any comments have been added.
Ref. RBC If the control type is a RETIC only, a REF. RBC heading and numeric value display on the
left side of the screen under the Summary Data columns. If the control is RETIC only and
the Reference RBC Target and Limit are not set, No Value will display in the Ref. RBC
field.

Thumbnail Levey-Jennings Graph

The thumbnail graph on the Quality Control (Data View) screen displays the ten latest run points
for the selected parameter (row).

Options on the Local Navigation Bar on the Quality Control Screen

Button Description
Select Control Allows you to select a control file to view. Refer to Select a Control in this
chapter for additional information.
View Graph (or View View Graph (on the Data View screen) -Allows you to view the control file
Data) results graphically.
View Data (on the Graph View screen) - Allows you to view the control file
results in table view.
View Log Allows you to view the History Log and default to the QC filter with the History
Logs. Refer to View Logs for control files in this chapter.
Details Allows you to view the Details of a control run.
Comment Allows you to add, modify or delete a comment for a run or control file. Refer
to Adding, Modifying and Deleting Comments in this chapter.
Filter Allows you to filter the view of a control file by using the following criteria:
• Number of Past Days
• Specific Date and Time Range
• Shift
Refer to Filtering the View in this chapter for additional information.
Delete Allows you to delete a selected run, all runs in the current filter, or all runs in
the current control file.
Transmit Allows you to Transmit Data to an LIS.
Systematic Random Allows you to review systematic, random errors and single measurement
Review errors. This button only displays on the Quality Control screen if Extended QC
is enabled. Refer to the Extended QC Setup section in the Setup chapter for
additional information.
More Options Allows you to choose between the following options:
• IQAP Web
• Export - to Export control file data to a .csv format viewable using any
major spreadsheet program, such as Microsoft® Excel®, or to export raw
data in INF/DAT format.
• QC Setup - to display the Quality Control Setup screen.

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Overview 4

Select a Control

1 From the Quality Control (Data View) screen or the Quality Control (Graph View) screen, select
the Select Control button on the Local Navigation Bar to display the QC Select Controls dialog
box.

Figure 4.3 QC Select Controls Dialog Box

2 Select a control and select the OK button.

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Quality Control
Overview

View Control Files Graphically (Menu > QA > QC > View Graph)
From the Quality Control - Data View screen, select the View Graph button.
OR
Select a parameter (row) and double tap the Thumbnail Levey-Jennings graph.

Figure 4.4 Quality Control (Graph View) Screen

The Quality Control (Graph View) screen displays the following:

• Up to 31 thumbnail Levey-Jennings graphs, one graph per parameter.


— The vertical bar corresponds to the current run.
— A red bar around a thumbnail graph indicates a QC Out point.

• An expanded Levey-Jennings graph for the selected parameter data.


Use the right and left arrows on the scroll bar under the expanded graph to view all of the data
points.
• Summary data for the selected parameter.
• Selected control lot status information.
• Selected filter information.

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Overview 4

Thumbnail Levey-Jennings Graph


The top half of the Quality Control (Graph View) screen displays all parameters associated with
controls. Up to 31 Thumbnail Levey-Jennings graphs display the latest run points for all parameters.
Each graph displays up to 10 points and these points change to reflect the scrolling of the expanded
graph. The points shown in the blue-shaded window of the expanded graph reflect those shown in
the thumbnail graphs.

The point cursor on the thumbnail graphs is synchronized with the selected run within the data
grid and the point cursor in the expanded graph.

If you select a thumbnail graph, that graph will be displayed as the expanded graph in the screen.
Any thumbnail graph’s border displays red if it contains a QC Out point. Once all runs in a graph are
reviewed, its border will return to normal color, but the QC Out point will remain red in the graph.
If the result violates the extended QC Single Measurement Error, the point will be yellow.

Expanded Levey-Jennings Graph


The expanded Levey-Jennings graph at the bottom of the Quality Control (Graph View) screen
displays all of the results for a selected parameter in the control file. The blue-shaded window on
the expanded graph, which contains up to 10 points and the point cursor, determines the points and
cursor displayed in the thumbnail graphs.

Point Cursor

The point cursor is a blue vertical line on the graph that reflects the date selected in the Data View.
The cursor can be moved left or right by either using the scroll bar or by selecting either the data
points on the graph or the control run analysis Date/Times (column heading) in the Data View table.
If the cursor moves to another point within the window, the window remains in place, and the
cursor moves within the window. The cursors in the thumbnail graphs move as well.
If the cursor moves to a point outside the window, the window shifts so that the new point displays
in the window as the furthest right or left point (depending on where the new point is). The points
displayed in the thumbnail graphs reflect those displayed in the window.

y-axis (Assigned Values)

The y-axis scale displays 5 coordinates. These are the expected limits, in currently configured units,
at the mean and +1 and +2 traditional expected limit and -1 and -2 traditional expected limit. For
Body Fluid Level 1, only the upper section (values above 0) displays, since the control does not have
a target +/- limit, but instead has an assigned upper limit.

x-axis (Individual Control Runs)

The x-axis displays up to 50 control runs. Ticks, representing each new day, display above the x-
axis. The name of the month displays above the tick representing the first day of a new month.

Points

Multiple runs for a single date display in chronological order, starting on the tick representing that
day. For example, three points for the date 12/1 display as three points in order between 12/1 and
12/2.
1. Points within range will display as a black circle.

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Quality Control
Overview

2. Points above or below the y-axis scale display as a red up-triangle or red down-triangle,
respectively.
3. Out conditions display as red points.
4. Excluded points display with a strike through them.
5. Points with Extended QC Single Measurement Error display in yellow.
6. Runs that are deleted from the control file will not be shown in the graph or data view.
7. Results that have non-numeric values, whether in an Included or an Excluded run, are not
plotted; however, a space on the x-axis displays where the result would have been if it had been
a numeric value.

NOTE Refer to the Options on the Local Navigation Bar on the Quality Control Screen section of this chapter
for additional information on the options on the Local Navigation bar.

View Logs
You can view History logs for control files by selecting the View Log button on the Quality Control
(Data View) screen or the Quality Control (Graph View) screen. It will take you to the Quality
Control Tab on the History Logs screen. Refer to APPENDIX C for additional information on viewing
logs.

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Overview 4

View Details of a Control Run


You can view control run details on the QC Run Details screen.

1 From the Quality Control - Data View screen, select a run and then select the Details button.
OR
From the Quality Control (Graph View), select the Details button.

Figure 4.5 QC Run Details Dialog Box

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Quality Control
Overview

The components on the QC Run Details screen are described below.

Component Description
Control ID Read-only field that displays the Control ID.
Source Read-only field that displays the control source
Type Read-only field that displays the control type.
Level Read-only field that displays the control level.
Exp. Date Read-only field that displays the control expiration date.
Tube Pos. ID Read-only field that displays the position of the tube in the cassette.
Date/Time Read-only field that displays the analysis date and time.
Presentation Method Read-only field that displays the presentation method. (Whether it was analyzed in a
cassette or in a single tube.)
Presented By Read-only field that displays one of the following:
• System - If the control was cassette presented, regardless of the operator logged
into the system at the time of presentation.
• An Operator ID - If the control was single-tube presented, this is the Operator ID
of the operator that was logged into the system at that time.
Report Status Read-only field that displays the report status for manually and automatically printed
reports.
LIS Status Read-only field that displays the status of the control results transmission to the LIS.
System Status Read-only field that displays the information related to the status of the SPM when
the specimen was run.
System Message Read-only field that displays the additional information related to specific codes and
flags.
Data Grid Read-only grid that displays the result and flag data in up to 3 groups. If the
traditional QC is Out, the result displays in red. If the result is outside of the upper and
lower Extended QC Single Measurement Error limits, the background color of the
result is yellow.
Histograms For LATRON Controls, 3 tabs display: DIFF, RETIC, and NRBC. Each tab includes up to
7 histograms: V, C, LALS, AL2, LMALS, MALS, and UMALS.
For BCI non-LATRON controls and Other non-LaserCheck controls, up to three
histograms will be displayed, depending on the control type:
• CDR: WBC, RBC, and PLT
• Body Fluids: TNC, RBC
Double -clicking a histogram displays a larger view of the histogram. Each histogram
is drawn in a black line and the area under the line is shaded as follows:
• WBC - light purple/lavender
• RBC - reddish orange/pink
• PLT - light green

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Overview 4

Component Description
Dataplots One 2-D dataplot displays. The type and tabs displayed on the dataplot depend on
the control type. A maximum of three tabs can display on one dataplot at one time.
If a type of analysis is disabled, then the corresponding dataplot does not display, and
as a result, the tab does not display as well.
The default tab that displays depends on what is available. The hierarchical order is
as follows: 5PD1, NRBC1, RETIC1.
Control Type Dataplot Displayed/Tab
CBC/DIFF 5PD1 and NRBC1
CBC/RETIC RETIC1
CBC/DIFF/RETIC 5PD1, NRBC1 and RETIC1
RETIC RETIC1
CBC None
LATRON Control None
View All VCS Graphics Displays all the VCSn graphics for the selected control run.
Print Select this button to manually print the Quality Control Reports
Additional Data Select this button to display the Additional Data window. Refer to the Viewing
Additional Data section of this chapter for additional information.

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Quality Control
Overview

View Additional Data


The Additional Data dialog box allows you to view additional data for a control run:

1 From the QC Run Details screen, select the Additional Data button to display the Additional Data
dialog box.

Figure 4.6 Additional Data Dialog Box

The Additional Data dialog box displays four tabbed views: CBC, DIFF, NRBC, and RETIC. For
component descriptions of this screen, refer to the Additional Data section of the Data Review
chapter.

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Overview 4

Add, Modify, or Delete Comments


You can add, modify or delete comments to control file records.

1 From the Quality Control (Data View) or Quality Control (Graph View) screen, select the
Comment button to display the QC Comment dialog box.

Figure 4.7 QC Comment Dialog Box

The creation date/time, last modified date/time, and last modified Operator ID will not be
populated until the entry of comment has been completed.

To Do this
1. Add or Modify a comment on a control run. Select the Run tab, type in the text box and select OK
2. Add or Modify a comment on a control file. Select the File tab, type in the text box and select OK
2. Delete a comment Select the Delete button.

Refer to Add, Modify and Delete Comments in the XB section of this chapter for information on XB
Comments.

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Overview

Filter the View


You can filter the view on the Quality Control (Data View) screen and the Quality Control (Graph
View) screen using the following criteria:

• All QC results within a number of days prior to and including the present day (Past Days)
• Specific date and time range
• Shift

1 From the Quality Control screen, select the Filter button to display the QC Filter dialog box.

Figure 4.8 QC Filter Dialog Box

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Overview 4

2 In the Choose Range box, select one of the filter option buttons:.
a. All - to view all the results
b. Past - to view results from a specific number of past days.
1) Type a number in the Past Days text box.
c. Specify Date and Time Range
1) Type or select a From and To Date.
2) Type or select a From and To Time.

3 In the Shift box, select one of the following option buttons to filter by shift:
• All - to view all shifts.
• 1 - to view only results from shift one
• 2 - to view only results from shift two.
• 3 - to view only results from shift three.

4 Select the OK button to save your filter selections.

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Quality Control
Overview

Delete Control File Records


You can delete control file records from the Quality Control (Data View) screen.

1 Select a run to delete and select the Delete button. The Delete dialog box displays.

Figure 4.9 Delete Dialog Box

2 Select one of the following option buttons:


• Selected Run - to delete the selected run.
• All Runs in Current Filter - to delete all the runs in the current filtered view.
• All Runs in Current Control File - to delete all runs in the current control file, regardless of
the filter applied to the view, if any.

3 Select the OK button to delete the selected runs. A warning dialog box displays.
The selected control runs will be permanently deleted from the system. Select OK to continue.

4 Select OK to permanently delete the control runs.


or
Select Cancel to close the dialog box without deleting the control runs.

NOTE A control run cannot be deleted if any of the following conditions exist:
• Control runs are not reviewed.
• Control runs are being modified by another user.
• Control runs are waiting to be sent to the LIS.

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Overview 4

Transmit Control Files


You can transmit control files to a Laboratory Information System (LIS).

1 From the Quality Control (Data View) screen, select the run that you want to transmit and select
the Transmit button. The Transmit dialog box displays.

Figure 4.10 Transmit Dialog Box

2 Select one of the following option buttons:


• Selected Run - to transmit the selected run only.
• All Runs in Current Filter - to transmit only the runs currently displayed in a filtered view
• All Runs in Current Control File - to transmit all runs in the current control file, regardless
of the filtered view, if any.

3 Select OK to transmit the runs.

NOTE If a report transmission is already in progress, one of the following messages will display:
• Report transmission is in progress for the selected result. Try again to transmit the result.

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Overview

View Control Files Under Error Conditions


Under error conditions the Quality Control Status icon at the top of the screen is red. If more than
one lot triggered an error condition, the Select Control File to Review dialog box displays. All lots
that are OUT are displayed on the dialog box. To view a specific lot, select the lot and select the OK
button.

Figure 4.11 Select Control File to Review Dialog Box

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Overview 4

Export Quality Control Data (Menu > QA > QC > More Options > Export)
Figure 4.12 Export Quality Control Dialog Box

1 Select a Format from the Type drop-down list.

2 In the Data Selection option box, select the data to export.

3 Select a Destination.

4 Select Start.

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Quality Control
Reports

Reports

Types
You can manually print the following types of reports from the Quality Control screen:

• Run Details Report


• Summary Report

• Extended QC Summary Report (If Extended QC is enabled.)


See APPENDIX D for examples of reports.

Printing

1 Select the Print icon at the top of the Quality Control screen to display the QC Report dialog box.

Figure 4.13 QC Report Dialog Box

2 Select one of the following options from the Report Type drop-down list:
• Run Details Report
• Summary Report

• Extended QC Summary Report (If extended QC is enabled.)

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3 Select one of the following option buttons from the Print option box:
• Selected Run - to print the selected run only
• All (Filtered Runs) - to print only the runs displayed in the current filtered view
• All Runs - to print all runs in the file selected

4 Select one or both of the following Print Options:


• Histograms - to print histograms
• Dataplots - to print dataplots

5 Select the Print button to print the report.

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XB Information

XB Information

Select Menu > QA > XB or the XB icon at the top of any screen in order to display the XB Review screen.
If the alert status icon was red, the screen will default to the application that contains XB or XM Out results
(whichever is enabled).

Setup
For instructions on setting up XB Analysis, refer to the XB (Menu > Setup > Quality Control > XB)
section of the Setup chapter.

Review
Review the results of XB Analysis from the XB Batch Means screen or the XB Batch Details screen.

XB Batch Means

Reviewing the XB Batch Means Screen

1 Select the XB/XM button from the top of any screen.

NOTE To toggle between XB and XM results, select the XB/XM button again to display the
alternate screen.

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XB Information 4

Figure 4.14 XB Batch Means (Data View) Screen

The XB Batch Means screen combines statistics data and thumbnail Levey-Jennings graphs for MCV,
MCH, and MCHC for all completed XB batches. Out of range batch means and percent differences
for MCV, MCH and MCHC display in red.

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XB Information

The XB Batch Means (Data View) screen columns are defined below.

Batch Date/Time Displays the batch completion date and time. If the batch out condition triggers
an XB/XM icon alert (red), the Batch Date/Time displays in red.

NOTE P indicates P.M. and A indicates A.M. in the Batch Date/Time column.
Reviewed By Displays the reviewer’s ID and the review date and time for the batch. If a batch
has not been reviewed, Click to Review displays in this column for that batch.
Select Click to Review in the Reviewed By column to review a batch.
Comment
Displays a Comment icon if a comment has been written for a batch.

NOTE To view the comment, select the batch row and select the Comment
button.
Delete Deletes the selected batch.

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XB Information 4

XB Batch Details
Selecting the Batch Details button on the XB Batch Means screen displays the XB Batch Details
screen of the batch selected from the XB Batch Means screen.

Figure 4.15 XB Batch Details Screen

Exclude
From the XB Batch Details screen, select the Exclude check box to exclude a run from statistical
calculations. Exclusions can only be made after the batch has been completed.

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XB Information

Graphics

Thumbnail Levey-Jennings Graphs


The XB Batch Means and XB Batch Details screens both display a thumbnail separate graph for MCV,
MCH, and MCHC. Each thumbnail graph displays all result points (up to 20 points) in the batch.

Point Cursor

The point cursor is a blue vertical line on the graph that reflects the analysis date of the selected
run in the date grid. The cursor can be moved left or right by either selecting another row in the
grid or by selecting the data points on the screen.

y-axis Assigned Values

The y-axis scale displays 5 coordinates. These are the assigned values in currently configured units
at the Target and at (Target + Limit), (Target - Limit), (Target +2x Limit), and (Target -2x Limit).
NOTE Assigned values that are entered as percentages display on the screen as actual numbers

x-axis
The x-axis displays up to 20 runs. Ticks representing each new day display below the x-axis. The
name of the month displays below the tick representing the first day of a new month. Only dates
with points to plot are displayed.

Points

Multiple batch runs for a single date display in chronological order, starting on the tick
representing the current day and ending before the tick representing the next day; for example,
three for the date 12/1 display as three points in order between 12/1 and 12/2.
• Points within range display in black
• Points above or below the y-axis scale display as red up or down triangles respectively.
• Excluded points display with a strike through them.

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XB Information 4

Add, Modify and Delete Comments

1 Select the Comments button to display the XB Comment dialog box.

2 To modify or add a comment, type in the text box and select OK.
or
To delete a comment, select the Delete button.

Figure 4.16 XB Comment Dialog Box

Delete XB
IMPORTANT Runs that are deleted do not display in any way on the graphs.

1 From the XB Batch Means screen, select the Delete button on the Navigation bar at the bottom
of the screen. If the current (batch in progress) is selected, the current will be deleted,
otherwise, the last completed batch will be deleted.

Reports

Types
You can manually print two types of XB Batch Reports:

• XB Batch Details Report

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XB Information

• XB Batch Means Report

See APPENDIX D for examples of reports.

Printing XB Batch Reports

1 Select the Print icon at the top of the XB review screens to display the Print XB Batch Reports
dialog box.

Figure 4.17 Print XB Batch Reports Dialog Box

2 Select from the following options:


• XB Batch Detail Report
— Currently Viewed Batch or All Batches
— Levey-Jennings Graphs
• XB Batch Means Report
— Levey-Jennings Graphs

3 Select Print.

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XB Information 4

Export XB
You can export XB results to a CD-ROM or a local drive on the System Manager. The exported data
is in a .csv format which can be read on any other computer that has a spreadsheet program.

1 Select the Export button to display the XB Batch Export dialog box.

Figure 4.18 XB Batch Export Dialog Box

2 Select from the following options:


• XB Batch Details Data
— Currently Viewed Batch
or
— All Batches
• XB Batch Means Data

3 Select a Destination.

4 Select Start.

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XM Information

XM Information

Setup
For instructions on setting up XM Quality Control, refer to the Quality Control (Menu > Setup >
Quality Control) section of the Setup Chapter.

Review (Menu > QA > XM)


Review the results of XM analysis from the XM Batch Means screen’s two views: Data View and
Graph View or from the XM Batch Details screen.

Reviewing the XM Batch Means Screen

1 Select the XB/XM button from the top of any screen to display the XM Batch means
screen.

NOTE If XB is enabled, you must tap the icon twice.

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XM Information 4

View Subsets from the XM Batch Means Screen


Figure 4.19 XM Batch Means (Data View) Screen

NOTE When the XM Batch Means (Data View) screen initially displays, it defaults to the tab or group that has
an Out condition. If no Out conditions exist for any enabled groups, the default tab is the first enabled
group in the following order: CBC, DIFF, RETIC, and RETIC CALC. If no group is enabled, the default tab is
CBC.

Each tab includes batch size, total batches, and calculated statistics data for each batch. When a
subset or test group is disabled, the tab for that subset displays the group name and the word
Disabled, for example, CBC Disabled.

The statistics for each batch are displayed in rows on XM Batch Means screen. The batches display
in the order that they were run, with the newest results at the top. The batch data column headings
on the XM Batch Means (Data View) screen are defined below.

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Quality Control
XM Information

Batch/Date Time Displays the batch completion date and time for the batch. If the batch
is Out, the Batch/Date Time displays in red. If the current batch has not
completed, Current Batch will display in the Batch/Date Time column for
that batch.
Reviewed By The Reviewed By column displays the reviewer’s ID and the review date
and time if a batch has been reviewed. If a batch has not yet been
reviewed, Click to Review will display in the Reviewed By column.
No Data Available will display in the Reviewed By column if there is no
data for the current batch.
In Progress displays in the Reviewed By column if there are some runs
for the current batch, however there is no data displayed in the
parameter columns.
Comment
Displays a Comment icon if a comment has been written for a
batch.

To Select
View batch details the Batch Details button.
View, modify or delete a the batch row and select the Comment button.
comment associated with a
batch

Summary Statistics
The summary statistics for all batches in a group or subset display at the bottom of each tab on the
XM Batch Means (Data View) screen. The data headings for the Summary Statistics on the XM Batch
Means (Data View) screen are defined below.

N Displays the number of runs in the current


batch.
Batch Size Displays the batch size for this group or
subset.
Total Batches Displays the number of batches for which
statistics are calculated. The system will
store a maximum of the last 20 completed
batches.
Target Displays the target value for each
parameter in the subset or group.
NOTE For instructions on defining parameters
for a group or subset, refer to XM in the
Setup chapter.

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Quality Control
XM Information 4

High Limit Displays the high limit value for each


parameter in a test group.
Low Limit Displays the low limit value for each
parameter in a test group.

Mark as Reviewed

1 To mark a batch as reviewed, select the Click to Review link that displays in the Reviewed By
column for that batch to display the Review Batches dialog box.

Figure 4.20 Review Batches Dialog Box

2 Select one of the following option buttons:


• Selected Batch (Default) to mark only the selected batch as reviewed.
• All OUT Batches to mark all out of range batches as reviewed.
• All IN Batches to mark all IN batches as reviewed.
• All Batches to mark all batches as reviewed.

3 Select OK to mark the appropriate batches as reviewed.


or
Select Cancel to return to the XM Batch Means screen without marking any batches as
reviewed.

NOTE Reviewed batches can not be reviewed again. If you attempt to review a batch that has already
been reviewed, the following message displays: This batch has been reviewed and cannot be
reviewed again.

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Quality Control
XM Information

XM Graph View
The XM Batch Means (Graph View) displays Levey-Jennings graphs for each test group or subset of
the XM Analysis. To display the Graph View select the View Graph button from the XM Batch Means
(Data View) screen. The XM Batch Means (Graph View) defaults to the tab view displayed by the XM
Batch Means (Data View) when the View Graph button is selected.

Figure 4.21 XM Batch Means (Graph View) Screen

Group Tabs
Each tab on the XM Batch Means (Graph View) screen displays Levey-Jennings graphs for a specific
test group. The title of the tab is the test name, such as CBC, DIFF, RETIC, or RETIC CALC. If a
particular test is disabled, the tab displays the test name and the word Disabled, such as CBC Disabled.

Thumbnail Levey-Jennings Graphs


A separate thumbnail Levey-Jennings graph displays for each test in a group. The thumbnail graph
shows all batch mean points for a maximum of 20 completed batches.

The point cursor, a vertical line on each thumbnail graph, is synchronized with the selected row in
the data grid on the XM Batch Means (Data View) screen.

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Quality Control
XM Information 4

A Levey-Jennings graph does not display for a test if any of the following conditions are met:

• The limit is set as manual update and the target value exceeds the low and high limits.
• The target value is equal to the low and high limits.
• The target value is empty.
• No data was collected.

Point Cursor

The point cursor is a blue vertical line on the graph that reflects the batch position (row) of the
selected batch in the list of batches. The cursor can be moved to the left or right by selecting
another row in the grid.

Y-Axis Assigned Values

The y-axis displays the XM test values. The y-axis displays the following coordinates for each
configured test in a group:

• Target Value
• Low Limit Value
• High Limit Value
• High Limit + (High Limit - Low Limit)/2
• Low Limit - (High Limit - Low Limit)/2

X- Axis Assigned Values

The x-axis displays the number of batches included in the statistical analysis. The x-axis displays a
maximum of 20 batch means. Ticks, representing each new batch, display below the x-axis.

Points

Points represent a batch mean value for a specific batch and are displayed in chronological order.
When a new batch completes, it displays in the right most tick in the x-axis. Move your cursor or
finger over the point to display the batch completion date and time.
Points within range are displayed in black. Points that cause violations will be displayed as follows:

• Points above or below the y-axis scale are displayed as a red up or down triangle.
• Points in XM Out conditions are displayed in red.

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Quality Control
XM Information

View XM Batch Details


From the XM Batch Means screen, select a batch data row and then the Batch Details button to
display the XM Batch Details screen. Use the scroll bar at the bottom of the screen to view all the
data.

Figure 4.22 XM Batch Details Screen

Add, Modify and Delete XM Comments

Add XM Comments

1 To add comments for XM batches, select a batch data row and then select the Comments button
at the bottom of the XM Batch Means screen to display the XM Comment dialog box.

2 Select the Batch tab to add a comment about the batch,

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Quality Control
XM Information 4

3 Type a comment in the text box and click OK to save the comment,
or
Select Cancel to exit the dialog box without saving the comment.

Modify XM Comments

1 From the XM Batch Means (Data View) screen, select a batch with a Comment icon in the
Comment column and then select the Comment button at the bottom of the screen.

2 Type in the text box and select OK to save the change.

Delete XM Comments

1 From the XM Batch Means (Data View) screen, select a batch with a Comment icon in the
Comment column and then select the Comment button at the bottom of the screen.

2 Select the Delete button on the XM Comment dialog box to delete the change.

Delete XM
From the XM Batch Means (Data View) screen, select Delete to delete the Last XM Batch, All XM Data
in the Selected Group or All XM Data in All Groups.

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Quality Control
XM Information

XM Reports

Types
The following types of reports can be manually printed from the XM Review screens:

• XM Batch Details Report


• XM Batch Means Report
• Levey-Jennings Graphs

See APPENDIX D for examples of reports.

Printing Reports

1 Select the global Print icon at the top of the XM Review screens to display the Print XM Batch
Reports dialog box.

Figure 4.23 Print XM Batch Reports Dialog Box

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Quality Control
XM Information 4

2 Select from the following options:


• XM Batch Details Report
— Selected Batch
or
— All Batches in Selected Group

• XM Batch Means Report


— CBC

— DIFF

— RETIC

— RETIC CALC

— Levey-Jennings Graphs

3 Select the OK button to print the selected reports.

Export
You can export XM results to a CD-ROM or a local drive on the System Manager. The exported data
is in a .csv format which can be read on any other computer that has a spreadsheet program.

1 From any XM Batch Means screen, select the Export button to display the XM Batch Export
dialog box.

629743AE 4-41
Quality Control
XM Information

Figure 4.24 XM Batch Export Dialog Box

2 Select from the following options:


• XM Batch Details Data
— Selected
or

— All Batches in Selected Group

• CBC
• DIFF
• RETIC
• RETIC CALC

3 Select the CD Recorder option if you want to export the data to a CD-ROM.

NOTE This process may take several minutes.

or
To save to a local drive, select the Local Drive option and then select the Select Folder button.
The Select Folder dialog box displays. Select or create a folder and select OK.

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Quality Control
XM Information 4

Figure 4.25 Select Folder Dialog Box

629743AE 4-43
Quality Control
XM Information

4-44 629743AE
CHAPTER 5

Sample Analysis

Specimen Collection

Whole Blood

Collect whole blood in EDTA according to tube manufacturer’s instructions and procedures in:5,6,7

• CLSI publication H4-A5 (for capillary)8


• CLSI publication H3-A6 (for venipuncture)9

Beckman Coulter recommends using K2 or K3 EDTA.

Body Fluids

To reduce body fluid sample viscosity, use hyaluronidase to treat synovial fluids prior to analysis
according to your laboratory standards. Add in the ratio of 1 mL of synovial fluid to 5 mg of
hyaluronidase. Mix for 5 minutes.

629743AE 5-1
Sample Analysis
Specimen Preparation (Pre-dilute)

CAUTION
If capillary tubes are used, they must be analyzed uncapped as open-vial samples.

CAUTION
Misleading results could occur if you fail to leave space at the top of the tube
between the sample and the stopper. Ensure you leave space at the top of the
tube between the sample and the stopper to facilitate automatic mixing. Follow
manufacturer’s recommendations for use of microcollection and venipuncture
devices.

CAUTION
For cassette presentation, you need at least 1.0 mL of sample for a 13 x 75 mm
tube, with proper proportion of blood to anticoagulant. Volumes may vary
depending on tube height and width.

CAUTION
Refer to your laboratory’s safety procedure for cleaning broken glass.

Specimen Preparation (Pre-dilute)

You can use the Dispense Diluent function on the Single-tube Presentation dialog box to acquire
diluent for use in your pre-dilute preparation.

1 Select the Single-tube Presentation icon at the top of any screen to display the
Single-tube Presentation Dialog Box.

2 Select the Dispense Diluent button and follow the prompts on the screen to acquire the diluent.

3 Follow your laboratory procedures for preparing your pre-dilute specimen.

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Sample Analysis
Placing the Bar-code Label on the Tube 5

Placing the Bar-code Label on the Tube

CAUTION
Risk of misidentification. Use of poor quality, dirty, improperly placed or damaged
bar-code labels could keep the SPM from reading the bar-code labels. Ensure the
bar-code labels are not damaged. Ensure the bar-code labels conform to the
specifications provided in the Bar-Code Label Specifications section of
APPENDIX A.

IMPORTANT When placing a label on a tube:


• Ensure the label is flattened smooth against the tube.
• Press the label down securely, including all the edges and the corners.
• Ensure that no part of the label is loose.

NOTE Do not place more than three labels on a tube.

Place the labels so that they are in the viewable area of the tube through the cassette window, as
shown in Figure 5.1. Do not place the label on the bottom 10 mm of the tube or the top 10 mm of the
tube or skew the label more than 12 degrees. These areas are not viewable due to the curvature of
the tube and the cassette window.
NOTE The top 10 mm dimension is measured from the bottom edge of the cap.

Figure 5.1 Placing a Label on a Tube

>10mm

>12˚

>10mm

629743AE 5-3
Sample Analysis
Load Cassettes

Load Cassettes

Cassette Handling
The cassette is the carrier for the sample tubes (patient control, or special test) used in cassette
presentation where automatic loading, mixing, and aspiration occurs.

Tubes should be pushed into the cassette with the tube bar-code labels facing up.

Always hold the cassette firmly by its edges. Do not try to hold or lift a cassette by grabbing a tube.
The weight of the remaining tubes could cause the cassette to fall.

Cleaning the Cassette

Refer to Clean the Cassettes in the Cleaning Procedures chapter of this manual.

Load the Cassette

WARNING
Risk of personal injury. Forcing a tube into the cassette improperly could cause it
to break. If a tube should break, use your laboratory’s safety procedure for
cleaning the broken glass.

CAUTION
Sample misidentification could occur if the appropriate bar-code labels are not
placed on the sample tubes. If not using bar-code labels, ensure you place the
tubes in the proper cassette positions.

1 Slide each sample firmly into the cassette.

2 Ensure the bar-codes are facing up within the cassette window.

5-4 629743AE
Sample Analysis
Load Cassettes 5

Figure 5.2 Example of Cassette with Tubes Loaded Correctly and Incorrectly
1 2 3 4

A
00041 00042 00043 00044 00045

In the figure above, 1 and 2 are examples of good placement, while examples 3 - 5 are examples of
incorrect placement.

629743AE 5-5
Sample Analysis
Add a Test Order

Add a Test Order

You can add a test order by automatically downloading the order from the LIS or by manual entry.

Automatic Download from LIS


Refer to the Host Transmission Manual that came with your DxH 800 System as well as the Setup
chapter of this manual for information on configuring download from the LIS.

Manual Entry (Menu > Worklist > Pending Tab)


From the Worklist - Pending Tab screen, select the Add Order button to display the Add Order
screen.

Figure 5.3 Worklist Screen

NOTE Batching must be disabled (off) in order to manually add a test order. If the Add Order button is
disabled, batching is enabled. Uncheck the Batching Enabled check box on the System Status screen.
Refer to Batching Enabled in the Setup chapter for additional instructions.

5-6 629743AE
Sample Analysis
Add a Test Order 5

Figure 5.4 Add Order Screen

NOTE Use the tab button to move through the fields on the Add Order screen.

Specimen Information Panel

1 If the Primary Identifier is Specimen ID, type a Specimen ID and press (Tab) .
or
If the Primary Identifier is Tube Position ID, type a Tube Position ID and press (Tab) .

2 Select a Specimen Type from the drop-down list.

3 Complete the remaining optional fields as desired:


• Specimen Priority
• Requisition
• Diagnosis
• Flagging set
• Draw Date
• Draw location
• Order Request Date
• Order Request Time

629743AE 5-7
Sample Analysis
Add a Test Order

• Ordering Physician

Available Panels

1 Verify the selected panel, or select a new Available Panel and select ADD to include it in the
Selected Panels list. Available panels vary depending on the Specimen Type selected. Refer to
Table 5.1 for a list of available panels.

2 Select Submit.

NOTE Orders that are added to the system, but have not yet been analyzed can be viewed on the
Worklist - Pending screen.

Table 5.1 Available Panels

Whole Blood CSF, Synovial, Pleural,


Peritoneal, Pericardial
CBC BFC
CD
CDR
CR
H&H
PLT
PREDI x5 (Predilute Whole Blood)
RETIC
WBC
WBC-NE#
WHP

Default Panel
Once you’ve selected a Panel, it comes up as the Default Panel the next time you add an order.

5-8 629743AE
Sample Analysis
Add a Test Order 5

Patient Information Panel

1 To add Patient demographics to an order, type the Patient ID in the Patient Information panel
and press (Tab) to display the Find Patient dialog box.

Figure 5.5 Find Patient Dialog Box

2 Select OK to add the patient’s demographics to the order.

NOTE To edit the Patient’s demographics, select Edit Patient. To add a Patient select the Add
Patient button. Refer to Demographics (Menu > Setup > Demographics) in the Setup chapter
for additional instructions.

When a Patient is associated with the test order, a Patient button is enabled on the Local Navigation
bar of the Add Order and Edit Order screens which allows you to select from the following options:

• Clear Patient: Allows you to "disassociate" the currently selected Patient from the Test Order. In
other words, it clears the patient panel and allows another patient to be selected.
• Edit Patient: Pops up the Edit Patient Demographics Dialog. Allows you to edit all of the patient
demographics with the exception of the Patient ID.

629743AE 5-9
Sample Analysis
Add a Test Order

• Rectify Patient ID: Allows you to enter the correct Patient ID (in case the Patient ID is wrong).
Refer to Rectify Patient ID in the Setup chapter for additional information.

Add Order Comments (Pending Tab > Add Order > Comments)
Figure 5.6 Comment Dialog Box

1 Select the Add button.

Figure 5.7 Add Comment Dialog Box

2 Select the Type of comment.

5-10 629743AE
Sample Analysis
Add a Test Order 5

3 Type a Comment in the text box or select the System Comment button to add a System
Comment.

NOTE If you type a comment here, that comment will be available for future selection in the list of
System Comments.

4 Select the Lab Use Only check box if this comment is for lab use only.

5 Select OK.

Edit a Test Order (Worklist > Pending Tab > Edit Order)

1 From the Pending tab, highlight the Order you want to edit and select the Edit button on the
local navigation bar.

Figure 5.8 Edit Order Screen

629743AE 5-11
Sample Analysis
Run Samples

2 Edit the information on the screen and select Submit.

Run Samples

Status

The SPM must be online to run samples. You can


view the status of the SPM in the Status Mode
area at the upper left hand corner of any screen.

Cassette Presentation

WARNING
Risk of personal injury. Attempting to correct an SPM problem while the SPM
continues to process samples could injure you.

CAUTION
To avoid erroneous results, do not use Cassette Presentation for Body Fluid or
Predilute samples.

1 Ensure the SPM is set up for the appropriate test for your workflow. For additional information
on adding a test order to the worklist, refer to Add a Test Order in this chapter.

2 Ensure your specimens have been collected and stored properly.

CAUTION
Misleading results can occur if specimens contain clots. Inspect specimens for
clots and use good laboratory practices for verifying results to ensure you do not
receive misleading results.

5-12 629743AE
Sample Analysis
Run Samples 5

3 Load the specimens into the cassettes.

CAUTION
Narrow tubes with small internal diameters will require manual premixing prior to
analysis to ensure proper cell and plasma distribution and to avoid possible
erroneous results. Premix these tubes before placing them in the cassette and
then analyze the cassette by pacing it in the Stat position of the Input Buffer. Refer
to the tube list at www.beckmancoulter.com for additional information.

00
04
1
00
04
2
00
04
3
00
04 A
4
00
04
5

4 Place the cassettes into the input buffer to the right of the SPM. The SPM automatically begins
cycling the cassettes.

629743AE 5-13
Sample Analysis
Run Samples

WARNING
To avoid serious injury, do not place your hand through the cassette presentation
opening on the SPM.

5 After the SPM cycles the samples, review the sample results at the System Manager. Refer to
the Data Review chapter for information on reviewing sample results.

5-14 629743AE
Sample Analysis
Run Samples 5

Single-tube Presentation

WARNING
Risk of personal injury. Attempting to correct an SPM problem while the SPM
continues to process samples could injure you.

CAUTION
To avoid erroneous results, do not run a Body Fluid sample in the whole blood
analyzing mode and do not run a whole blood sample in any body fluid analyzing
mode.

IMPORTANT Beckman Coulter recommends that a diluent be run as a Body Fluid sample prior to analysis
of Body Fluid specimens to verify acceptable backgrounds.

1 Ensure your specimens have been collected and stored properly.

CAUTION
Misleading results can occur if specimens contain clots. Inspect specimens for
clots and use good laboratory practices for verifying results to ensure you do not
receive misleading results.

2 Select the Single-tube Presentation icon at the top of any screen to display the
Single-tube Presentation dialog box.

629743AE 5-15
Sample Analysis
Run Samples

Figure 5.9 Single-tube Presentation Dialog Box

3 Place the specimen on the bar-code reader platform of the Single-tube Presentation Station
with the bar code facing the SPM to allow the Single-Tube Presentation Bar-code Reader to scan
the specimen label. .

or
Type the Specimen Identifier and press (ENTER) .
or

5-16 629743AE
Sample Analysis
Run Samples 5

Scan the bar code with the handheld scanner. Move the cursor to the end of the ID field by
touching the end of the ID or using the mouse to click at the at the end of the ID. Then, press
(ENTER) . Refer to Using the Handheld Scanner for additional instructions.

4 Verify the Specimen Identifier and Test request. Acknowledging the ID that displays on the
System Manager screen indicates that you accept the bar-code label read or manual entry.

5 Mix the specimen according to your laboratory standards.

CAUTION
Sample must be properly mixed before analysis. To avoid improperly mixed
sample, do not overfill sample tube.

CAUTION
Narrow tubes with small internal diameters will require manual premixing prior to
analysis to ensure proper cell and plasma distribution and avoid possible
erroneous results. Premix these tubes immediately before placing them in the
Single-tube Station cradle. Refer to the tube list at www.beckmancoulter.com for
additional information.

6 Place the specimen into the correct Single-tube position.

WARNING
To avoid serious injury, do not place your hands through the manual station
opening when the SPM is powered on.

629743AE 5-17
Sample Analysis
Run Samples

CAUTION
Do not place a closed tube or a 16 mm diameter tube in the right position of the
Single-tube Presentation Station. Doing so could result in an incomplete
aspiration and an erroneous result.

Using the Handheld Scanner


Your DxH 800 handheld scanner is a camera that takes a picture of the bar code.

1 Aim the scanner at the bar code as if you were taking a picture.

2 Slowly move the scanner closer to the bar code (allowing the camera to focus) until you hear a
beep. If you do not hear a beep, ensure that the scanner is:
• correctly connected to your System Manager
• correctly configured for your labels.

5-18 629743AE
Sample Analysis
Run Samples 5

CAUTION
Risk of sample misidentification. When using the handheld scanner, occasional
misread errors can occur as a result of partial label scans and damaged or
misapplied labels. Beckman Coulter recommends that you verify each bar-code
reading to ensure correct patient identification.

Studies
Studies allows you to run samples without test orders multiple times without using Rerun or Reflex
analysis. In order to run Studies, Batching must be enabled. Studies results can be viewed on the
Worklist - Custom screen by using the Studies filter. The first three characters of the Specimen ID
or Tube Position ID for Studies results is always “XS-”.

Batching
Batching allows you to run samples without test orders; however, you cannot run a sample multiple
times unless you use the Rerun or Reflex options. A Default Test Order (Menu > System Status) must
be defined for Batched samples. Refer to Batching Enabled in the Setup chapter for additional
instructions.

Handling Alarms
An audible or visible alarm on the DxH 800 System should be addressed by reviewing the Event Logs
on the History Log screen. Refer to APPENDIX C for additional information on History Logs. To
configure audible alarms, refer to Audible Alarms (Menu > Setup > System > Audible Alarms) in the
Setup chapter.

629743AE 5-19
Sample Analysis
Run Samples

5-20 629743AE
CHAPTER 6

Data Review

Worklist Screen

The Worklist screen manages test orders and results within the database. The Worklist
screen allows you to:
• Use predefined filters for display and monitoring of patient test orders and results
• Specify sort/filter criteria for display and monitoring of patient test orders and results
• Add, delete and modify patient test orders
• Print, transmit, and export patient results
• Clear notification for specimens that were not processed.

To access the Worklist screen:

Select the Worklist Icon from the top of any screen.


or
Select Menu > Worklist.

Worklist Screen Layout


The five tabs on the Worklist screen are:

• Pending
• Not Processed
• Review
• Released
• Custom

Each tab displays a particular filter view of the database. The Review, Released, and Custom tabs
organize information according to the currently selected filter. Only one tab can be viewed at a
time.

629743AE 6-1
Data Review
Worklist Screen

IMPORTANT The green Refresh icon at the top of the screen, shown in the figure below, indicates that you
need to select the Refresh button on the Local Navigation bar at the bottom of the screen.

For each tab:

• Disabled parameters (via Setup > System > Analysis) are disabled (grayed out) on any tab.
• Disabled parameters (via Setup > Reporting > Tests) are not displayed on any tab.
• For unreleased results with multiple runs, the last run (most recent) displays.
• Rejected results display with ##### signs.
• Unreleased values display in brackets.
• Unordered but received parameters display in a grayed out color.

• A “lock” icon displays in the first column for any result that is saved, meaning it cannot be
removed, pruned, or deleted.
• Data that does not match the filter criteria is not displayed.
• If a row no longer matches the filter criteria (for example, Pending Tab is selected and all tests
are now completed), all fields display in a disabled color.

6-2 629743AE
Data Review
Worklist Screen 6

Pending Tab(Menu > Worklist > Pending Tab)


Figure 6.1 Worklist -Pending Tab

The Pending tab displays all patient test orders with a pending or partially complete result status
(any result status that is not complete).

The default sort order on the Pending tab for a new use session is listed below. The default sort order
within same user session is the last selected sort order.

Primary Order Received Date/Time, oldest to newest


Secondary Primary Identifier (Specimen ID or Tube Position
ID) in ascending order.

629743AE 6-3
Data Review
Worklist Screen

The Components on the Worklist- Pending screen are outlined below:

Component Description
Results Found Read-only field that displays the total number of results found for the tab. If no
entries are found, this field displays 0 (zero).
Specimen ID If Specimen ID is the selected primary identifier, then this is the specimen’s
unique identifier.
Tube Pos. ID If Tube Position ID is the selected primary identifier, then this is the specimen’s
unique identifier.
Order Received The date and time that the order was received.
Date/Time
Request Date Time The date and time that the order was requested.
Specimen Status The status of the specimen.
Action Status Displays the follow-up work to be performed on a specimen, such as Rerun or
Reflex, or both.
Priority The priority of the specimen.
Add Order Selecting this button allows you to add a test order. For instructions on adding and
order, refer to Add a Test Order in the Sample Analysis chapter.
Edit Order Selecting this button allows you to edit a test order. For instructions on editing an
order, refer to Edit a Test Order (Worklist > Pending Tab > Edit Order) in the
Sample Analysis chapter.
Details Displays the details of the pending order on the Patient Results screen.
Remove Allows you to remove all selected test orders or all test orders in current filter.
View Log Displays the History Log screen.
Delete Allows you to delete all selected test orders or all test orders in current filter.
Refresh Refreshes the screen so that it reflects the most recent changes.
More Allows you to Save (prevent deletion) or Unsave (allow deletion) of a Test Order.

6-4 629743AE
Data Review
Worklist Screen 6

Remove Pending Orders


Remove hides a pending order from view on the worklist tab, although it remains pending. You can
view Removed orders from the Custom tab by selecting the Removed filter.

Figure 6.2 Remove Pending Orders Dialog Box

Select the orders that you want to remove on the Remove pending orders dialog box and select OK.

629743AE 6-5
Data Review
Worklist Screen

Delete Pending Orders


You can delete pending orders automatically or manually. Refer to Database Cleanup (Menu >
Setup > System > Database Cleanup) in the Setup chapter for additional information on automatic
deletion.

To manually delete pending orders, select the Delete Order button on the Navigation bar at the
bottom of the Worklist-Pending screen to delete selected orders from the database. Deleted orders
are no longer viewable or accessible once deleted from any tab.

Figure 6.3 Delete Orders Dialog Box

Save Orders
Select More > Save on the Navigation bar at the bottom of the Worklist-Pending screen to prevent
an order from being manually or automatically deleted by any automated database maintenance
routines that you may have configured to periodically open up space on your system.

Unsave Orders
Select More > Unsave on the Navigation bar at the bottom of the Worklist- Pending screen.
Unsaving an order allows it to be deleted manually or by any automated database maintenance
routines that you have configured to periodically open up space on your system.

6-6 629743AE
Data Review
Worklist Screen 6

Not Processed Tab(Menu > Worklist > Not Processed Tab)

The Worklist - Not Processed tab displays exceptions for specimens that have been
skipped. You need to address the problem and reload the skipped specimens for processing. If
exceptions are posted to the Not Processed tab, the Worklist alert status icon is red. This tab (view)
automatically displays when you click the red Worklist icon.

Figure 6.4 Worklist - Not Processed Tab

Specimens skipped because of a No Read or a No Match are posted to the Not Processed Tab. A
corresponding Event is posted in the Event Log for each. Refer to APPENDIX C for information on
working with logs.

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The components on the Worklist - Not Processed screen are outlined below:

Component Description
Results Found Read-only field that displays the total number of results
found for the tab.
Date Time of Event The date and time of the event that placed the skipped
specimen into the Not Processed group.
Exception Status The Exception Status, such as No Read.
Specimen ID The specimen’s unique identifier.
Tube Pos. ID The tube position ID.
Message A message associated with the Exception that caused the
specimen to be skipped.
Clear Select this button to clear exceptions on skipped specimens.
View Log Select this button to display the History Logs screen.
Refresh Select this button to refresh the screen.

Clearing an Exception from the Not Processed Tab

1 From the Worklist - Not Processed tab, select or the Exceptions you want to clear.

2 Select the Clear button to display the Clear Exceptions dialog box.

Figure 6.5 Clear Exceptions Dialog Box

3 Select from the following options:


• Selected Exceptions
• All Exceptions in Current Filter

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4 Select OK to clear the selected exceptions.

Review Tab(Menu > Worklist > Review Tab)


The Worklist -Review tab displays specimens that have been held (not released) and require
attention.

Figure 6.6 Worklist - Review Tab

Use the scroll bar to view all the components and data on this screen. The Filter at top right allows
you to search by the following:

• All Held
• Held with Exception Status
• Held with Slide Review Action
To release a result, you must be at the Patient Results screen. Double click or double tap a result to
display the Patient Results screen and follow the instructions in the Release/Reject Results section
of this chapter.

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The options on the Worklist-Review tab are outlined below:

Component Function
Specimen ID If Specimen ID is the selected primary identifier, then this is the specimen’s
unique identifier.
Tube Pos. ID If Tube Position ID is the selected primary identifier, then this is the
specimen’s unique identifier.
Exception Status The Exception Status, such as Default Test Order or Inconsistent
Demographics.
Patient ID The patient’s unique identifier.
Last Name The patient’s last name.
First Name The patient’s first name.
Priority The test order priority.
Panels The test panels that were run.
Action Status Displays the follow-up work to be performed on a specimen, such as Rerun
or Reflex, or both.
Analysis Date/Time The analysis date and time.
Patient Location The patient location.
Physician The ordering physician.
CBC Results for CBC Parameters.
Diff Results for Diff Parameters.
Retic Results for Retic Parameters.
BFC Results for Body Fluid Count.
Edit Order Selecting this button allows you to edit a test order. For instructions on
editing an order, refer to Edit a Test Order (Worklist > Pending Tab > Edit
Order) in the Sample Analysis chapter.
Details Displays the details of the pending order on the Patient Results screen.
View Log Displays the History Log screen.
Delete Orders Allows you to delete all selected test orders or all test orders in current filter.
Export Allows you to export data.
Refresh Refreshes the screen so that it reflects the most recent changes.
More Allows you to Save (prevent deletion) or Unsave (allow deletion) of a Test
Order.

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Released Tab(Menu > Worklist > Released Tab)


The Worklist - Released tab displays the released results according to the filter that you select.

Figure 6.7 Worklist - Released Tab

The Filter Name drop-down list at the top right of the Released Tab allows you to filter by the
following:

• All
• All (Last 30 Days)

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The components on the Released tab are described below.

Component Function
Specimen ID If Specimen ID is the selected primary identifier, then this is the specimen’s
unique identifier.
Tube Pos. ID If Tube Position ID is the selected primary identifier, then this is the
specimen’s unique identifier.
Patient ID The patient’s unique identifier.
Last Name The patient’s last name.
First Name The patient’s first name.
Priority The test order priority.
Panels The test panels that were run.
Release
Analysis Date/Time The analysis date and time.
Patient Location The patient location.
Physician The ordering physician.
CBC Results for CBC Parameters.
Diff Results for Diff Parameters.
Retic Results for Retic Parameters.
BFC Results for Body Fluid Count.
Transmit Allows you to transmit Released Results to an LIS.
Edit Order Selecting this button allows you to edit a test order. For instructions on
editing an order, refer to Edit a Test Order (Worklist > Pending Tab > Edit
Order) in the Sample Analysis chapter.
Details Displays the details of the pending order on the Patient Results screen.
View Log Displays the History Log screen.
Delete Orders Allows you to delete all selected test orders or all test orders in current filter.
Export Allows you to export data.
Refresh Refreshes the screen so that it reflects the most recent changes.
More Allows you to Save (prevent deletion) or Unsave (allow deletion) of a Test
Order.

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Transmit Released Results to the LIS

1 From the Worklist - Release Results screen, select the Transmit button to display the Transmit
dialog box.

Figure 6.8 Transmit Dialog Box

2 Select from the following options in the Transmit option box:


• Selected Results
• All Results in Current Filter

3 Select OK to transmit the results.

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Export Released Results (Released Tab > Export)


Preparing .CSV creates two line items files available for import to a spreadsheet program (such as
Microsoft Excel). Preparing INF/DAT files saves raw data offline.

Figure 6.9 Export Dialog Box

1 Select a type of file to export to:


• .CSV
• INF/DAT (raw data)

2 Select the data to export from the Data Selection option box.

3 Select a Destination and select Start.

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Custom Tab(Menu > Worklist > Custom Tab)


The Worklist - Custom tab allows you to select from predefined or user-defined filters.

Figure 6.10 Worklist - Custom Tab

Custom Tab Filter


Select from the following options in the Filter Name drop-down list:

• Chartable Report Not Printed


• Lab Report Not Printed
• Not Transmitted
• Rejected
• Removed
• Studies
• Your Custom Filters (Refer to the Custom Worklist Filter Configuration (Menu > Worklist >
Custom Tab > Advanced Search) section in the Setup chapter for instructions on configuring
your custom filter.)

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The components on the Custom tab are described below,

Component Function
Specimen ID If Specimen ID is the selected primary identifier, then this is the specimen’s
unique identifier.
Tube Pos. ID If Tube Position ID is the selected primary identifier, then this is the
specimen’s unique identifier.
Patient ID The patient’s unique identifier.
Last Name The patient’s last name.
First Name The patient’s first name.
Priority The test order priority.
Panels The test panels that were run.
Release
Analysis Date/Time The analysis date and time.
Patient Location The patient location.
Physician The ordering physician.
CBC Results for CBC Parameters.
Diff Results for Diff Parameters.
Retic Results for Retic Parameters.
BFC Results for Body Fluid Count.
Transmit Allows you to transmit Released Results to an LIS.
Edit Order Selecting this button allows you to edit a test order. For instructions on
editing an order, refer to Edit a Test Order (Worklist > Pending Tab > Edit
Order) in the Sample Analysis chapter.
Details Displays the details of the pending order on the Patient Results screen.
Advanced Search Allows you to configure a custom filter.
View Log Displays the History Log screen.
Delete Orders Allows you to delete all selected test orders or all test orders in current filter.
Export Allows you to export data.
Refresh Refreshes the screen so that it reflects the most recent changes.
More Allows you to Save (prevent deletion) or Unsave (allow deletion) of a Test
Order.

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How to Review Patient Results

To access the Patient Results screen, do one of the following:

• Select Menu > Patient Results.


• Select a result, then select the Details button on the Worklist screen.
• Tap a result twice on the Worklist screen.

Figure 6.11 Patient Results Screen

On the Patient Results screen:

• Results are highlighted with a yellow background if action limits are exceeded and results are
highlighted with a red background if critical limits are exceeded.
• Flags are contained in a column next to results.
• Non-numeric codes replace results.
Refer to Processing Results in this chapter for additional information on codes and flagging.
• The Panels Tab is the default tab when there is only one Run Order for a patient's results.
• A History tab will be available on the Patient Results screen if there is one or more released
specimens associated with the patient.
• A Rerun tab will display if a Rerun has been done.

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• The area immediately to the right of the Tabs displays System Statuses, such as the Comment
icon and “Specimen Deleted.” Also in this area, all the way to the right is the Patient Results
Display Mode, which is either Dynamic or Filter.

The components on the Patient Results screen are described below.

Component Description
Specimen ID A demographic field displays the Specimen ID for a patient specimen.
This field also acts as a button that, when selected, takes you to the
Edit Order -Specimen window.
Tube Pos. ID A demographic field displays the Tube Position ID.
Patient Name A demographic field displays the patient’s name, last name first. This
field also acts as a button that, when selected, takes you to the Patient
ID search dialog box.
Patient ID A demographic field displays the unique identifier for the patient
whose specimen is associated with a given test order.
The Patient ID takes you to the Edit Test Order dialog box. With the
Patient Tab selected, if the "..." button is selected, then the Find Patient
Dialog is displayed.
Age A demographic field displays the patient’s age with the corresponding
units.
Gender A demographic field displays the patient’s gender.
Diagnosis A demographic field displays the patient’s diagnosis.
Location A demographic field displays the location where the specimen was
collected.
Tabs Tabs display when different views are available, such as Panel Name
(for example, CDR), History and Rerun. The History and Rerun tabs do
not display if a history or rerun does not exist.
Susp/Sys/Def Msgs Displays the messages in three categories: Suspect (in red), System
(in green), Definitive (in blue). Messages within each subset of
messages display in alphabetical order. Use the scroll bar to view all
messages in the list box.
Lab Actions Box Displays the rule message for Lab Actions. Use the scroll bar to view
all messages in the list box.
Rerun\Reflex Selecting this button displays the option buttons for Reflex and Rerun.
Edit Displays the Edit Patient Results window.
View Log Displays the History Logs window.
Additional Data Displays the Additional Data window.
Comment Allows you to add a comment.
Show Delta Shows the difference between the results when Delta Checks are
enabled. Results are displayed in Show Delta and Show Previous when
a previously released sample with the same Patient ID is available.
Show Delta shows the delta values according to the settings you
programmed in Rules > Delta. Show Previous shows the actual former
values. You can toggle between Show Delta and Show Previous.

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Component Description
Release Selecting this button releases the patient result.
Reject Selecting this button rejects the patient result.
More Selecting this button displays the Rules Triggered button. If the
specimen is collated, the View Source button displays. If the
specimen is the source for a collated specimen, the View Collation
button displays.

Dynamic Mode
When the Patient Results screen is accessed via the Patient Results button on the Main Menu or the
Single-tube Presentation icon, the screen will display in Dynamic Mode. In Dynamic Mode, all
results processed since the Data Manager was started will be available, with the most recent
currently visible. When a new specimen is analyzed, its results appear on the screen, replacing the
currently displayed specimen’s results. When the screen is in Dynamic Mode, you can lock it so that
it does not update dynamically when reviewing results. As soon as it is unlocked, the result of the
last specimen analyzed displays.

Lock Status
The Patient Results screen displays Dynamic (Unlocked) or Dynamic (Locked) in the upper right
hand corner to indicate the lock status.

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Lock/Unlock the Screen


To lock the screen, select the “unlocked” icon, as shown below, in the navigation panel on the
Patient Results screen. To unlock the screen, select the “locked” icon.

Static Mode
The Patient Results screen is in Static Mode when the screen is accessed via the Details button on
the Worklist screen.

From the Worklist Tab


The name of the Worklist tab from which you accessed the Patient Results screen displays in the
Filter field on the Patient Results screen. Using the arrow keys on the keyboard, you can navigate
through a fixed set of results filtered by the current Worklist tab.

Auto-Refresh

If you access the Patient Results screen from the Reviewed Tab of the Worklist screen, when the last
item in the list is addressed, Final Released or Rejected, the system will automatically refresh to
display any new results. If any results have not been addressed, these will display as well.

Quick Search Mode


The Patient Results screen will be in static mode when accessed via the Specimen Search function.
The Status Indicator field displays Specimen Search. In this mode, you can only review the one
result selected from the Specimen Search.

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Description of Histogram/Dataplot Content on the Patient Results Screen

Histograms The main Patient Results screen displays WBC, RBC, and PLT histograms. For BFC
panels, a TNC and RBC histogram are available.Double clicking or tapping a
histogram pops up a larger view of the histograms.

Histograms show relative cell frequency versus size. They provide information about ertythrocyte, leukocyte,
and thrombocyte frequency. Histograms provide a means of comparing the sizes of a patient’s cells with normal
populations.

IMPORTANT Histograms show only the relative, not actual, number of cells in each size range. Do not estimate
the number of cells from the distribution curves.

When reviewing histograms, inspect:


• Position of individual populations as compared to normal/typical positions.
• Amount of separation between populations as compared to normal/typical separation.
• Relative concentration of each population as compared to normal/typical concentrations.
• Presence of unexpected or non-typical populations.

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Dataplots A maximum of three tabs display dataplots, depending on the test order,
according to the following rules:
• If Diff was ordered, 5PD1 and NRBC1 tabs and dataplots display.
• If Retic was ordered, a RETIC1 tab and dataplot displays.
• If a module is disabled, the corresponding dataplot does not display.
Figure 6.12 NRBC1 For each type of graph and tabbed dataplot, the colors correlate to populations
with the light, bright colors representing a dense or greater number of cells and
dark colors representing the least dense or least number of cells.
Population colors for the NRBC Dataplot are:
• NRBC - Light to dark, true red
• Other - Light, fluorescent green to dark green.
• WBC - Light, bright blue to dark blue.
Figure 6.13 5PD1
Populations colors for the WBC Differential Dataplot are:
• Lymphocytes - Light, bright blue to dark blue.
• Neutrophils - Light, bright pink/purple to dark purplish red.
• Eosinophils - Light, bright orange to dark reddish orange.
• Monocytes - Light, fluorescent green to dark green.
• Basophils - White to bright yellow.
Figure 6.14 RETIC1 • Non-whites - Light to dark, true red.
Population colors for the Reticulocyte Dataplot are:
• RBCs - Light to dark, true red.
• Reticulocytes - Light to dark purple.
• Other - Light fluorescent green to dark green.
• White Blood Cells - Light, bright blue to dark blue.

Additional Data
From the Patient Results screen, select the Additional Data button to display the Additional Data
screen.

The Additional Data Screen provides you with a view of additional data for four run modes: CBC,
Diff, NRBC, and Retic. For BFC panels, a BFC Tab displays TNC and RBC test results, and
corresponding histograms.

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Additional Data CBC Tab


Select the CBC tab on the Additional Data screen to display additional CBC data.

Figure 6.15 Additional Data - CBC Screen

You can toggle the check box next to each Aperture to alternately display or remove the histogram
data displayed for that Aperture. The Histograms, to the left of the aperture data, display the
histogram data for WBC, RBC, and PLT. The lines are color coded to correspond to the apertures.
Aperture 1 is purple; Aperture 2 is blue; and Aperture 3 is yellow; the average histogram is black. If
partial vote out has occurred, the field in Aperture group box will be highlighted in yellow.

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Additional Data DIFF Tab


Select the DIFF tab on the Additional Data screen to display additional DIFF data.

Figure 6.16 Additional Data -DIFF Tab

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Additional Data NRBC Tab


Select the NRBC tab on the Additional Data screen to display additional NRBC data.

Figure 6.17 Additional Data - NRBC Screen

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Additional Data RETIC Tab


Select the Retic tab on the Additional Data screen to display additional Retic data.

Figure 6.18 Additional Data - Retic Screen

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View All VCSn Graphics


Histograms and 2-D Dataplots of the patient results display on the Patient Results screen. To view
specific population and test panels as well as 3-D dataplots, select the View All VCSn Graphics button
on the Patient Results screen. The View All VCSn Graphics screen displays.

Figure 6.19 View All VCSn Graphics Screen

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The components on the View All VCSn Graphics dialog box are described below.

Component Function
Data Group Box Three radio buttons allow you to select data to view: DIFF, NRBC, or RETIC.
Type Group Box Three radio buttons allow you to select which graphics to view: 2D dataplots,
Surface Plots, or a 3-D Cube.
Analysis Group This group box applies to Surface Plots and 3-D Cube. It is disabled for 2D
Box dataplots.Three buttons allow you to Rewind, Play, and Fast Forward.
Rewind: Resets the graphic to the beginning of data collection (time = 0). No data
displays.
Play: Graph updates with incoming data in an animated fashion. Starting at
time=0 and proceeding until time=end, the data displays in the order that it was
collected.
Fast Forward: Resets the graphic to the end of data collection. All data displays.
View Angle Group Six buttons allow you to select the angle of Surface plots and 3D Cubes. You can
Box (disabled for also use the mouse to click and drag over the graphic to change the view angle.
2-D Surface Plots)
Reset: Resets the view back to the default angle.
Auto Rotate: Selecting this button sets the graphic into rotational motion and
selecting it again stops the motion.
Display Enabled for all display types. Allows you to select populations to include in or
Populations remove from the graphic.

View VCSn Graphics

1 Select a test panel from the Data panel option buttons:


• Diff
• NRBC
• Retic

2 Select a type of graphic from the Type panel option buttons:


• 2-D Dataplots
• Surface Plots
• 3-D Cube

3 In the Display Populations panel, uncheck populations that you do not want to display. (These
check boxes are automatically checked by default.)

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4 If you selected Surface Plot or 3-D Cube, use the View Angle and Analysis navigation buttons to
change your view of the graphic.

NOTE Select the Circular Arrow button to rotate the graphic in a continuous circle. To stop the rotating
graphic, select the Circular Arrow button again. The Analysis buttons allow you to view the
accumulation of populations.

Figure 6.20 Surface Plots

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Figure 6.21 3-D Cube

View Rules Triggered (Patient Results > More > Rules Triggered)
Figure 6.22 Rules Triggered Dialog Box

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View Collation(Patient Results > More > View Collation)


Collation enables the addition of a Retic panel to a previously analyzed and released C or CD panel
for a specific patient. The Retic panel order that is added must have the same Specimen ID and
Patient ID of the specimen (C or CD) released.

After analysis of the added Retic panel the Patient Results screen will display the C or CD results
with the added Retic results. The display will state that the results were collated.

Refer to Collation (Menu > Setup > Flagging/Rules > Collation) in the Setup chapter for instructions
on enabling Auto Collation. From the Collated view, select More > View Source to display the source
on the Patient Results screen.

Figure 6.23 Collated Patient Results Example

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View Source (Patient Results > More > View Source)


If the current specimen is collated, select View Source to shift the current specimen being viewed
to the specimen used as the source of the collation. From the collation source view of the Patient
Results screen, select More > View Collation to return to the original collated specimen.

NOTE If the screen is in dynamic mode, the screen will be locked. The screen will remain locked when the
screen returns to the original collated specimen, until unlocked by the operator.

Figure 6.24 Collation Source on the Patient Results Screen

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View Previous or Next Patient Results


You can view previous or next patient results from the Patient Results screen using the navigation
buttons at the bottom right hand corner of the screen.

Figure 6.25 Navigation Buttons on the Patient Results Screen

1. First result in the database.


2. Last result in the database.
3. Previous
4. Next

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View Rerun Tab


A Rerun tab displays on the Patient Results screen if a Rerun has occurred.

Figure 6.26 Patient Results - Rerun Tab

On the Rerun tab:


• Comments are indicated by the Comment icon at the top right of the Patient Results screen.
• Rerun results are associated with the primary specimen identifier.
• The most recent run is on the left.
• You can view up to three reruns.
• The graphics, comment, lab actions and messages are displayed for the checked run. Use the
check box to toggle between runs.
• Local navigation buttons function for the checked results.

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View History Tab


A History tab displays on the Patient Results screen if one or more released specimens are
associated with a patient.

Figure 6.27 Patient Results - History Tab

On the History tab:

• History is based on Patient ID.


• You can view up to three analyses from the same Patient ID. The three analysis are the three
most recently released results.
• You can see the current run (the selected run for the most current results if more than one run
is available).
• Graphics, comments, lab actions and messages are shown for the result set highlighted in blue

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Reflex
After reviewing patient results, you can run a test that you did not already order for a specimen, but
would like to run based on the results, doctor’s orders, or decision rules. Running a test that has not
already been ordered is called running a Reflex analysis.

The instructions that follow are for ordering a Reflex manually. Reflex tests can also be ordered
through Decision Rules and in downloads from a host.

1 Select Reflex/Rerun > Reflex on the Patient Results screen to display the Select Panels to Reflex
pop-up window.

NOTE You can only reflex a panel that has not already been run on a test order.

Figure 6.28 Select Panel(s) to Reflex Dialog Box

2 Select from the list of available panels and then select the Add button.

3 Select OK to run the reflex. If the specimen is still “active” in the system, the Reflex will run
automatically. If the specimen is in the output buffer, you need to retrieve it and place the
specimen in the input buffer.

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Rerun
After reviewing patient results, you can rerun a patient sample with the same ordered tests that
were originally ordered. This type of analysis is called a Rerun. The Patient Results screen will
display a Rerun tab when a Rerun is presented on the SPM.

The instructions that follow give details for ordering a Rerun manually. Reruns can also be initiated
through Decision Rules and downloads from a host.The Rerun/Reflex button also allows you the
option to Cancel any Rerun or Reflex panels that pending. Reruns cannot be ordered from an LIS.

1 Select Reflex/Rerun > Rerun to rerun the sample.

Figure 6.29 Rerun Dialog Box

2 Select OK to rerun the panels or Cancel to exit the dialog box without running the panels. If you
select OK and the specimen is still “active” in the system, the Rerun will run automatically. If
the specimen is in the output buffer, you need to retrieve it and place the specimen in the input
buffer.

View Log
Refer to APPENDIX C for information on viewing History Logs.

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Edit Patient Results


NOTE The option to Edit is not available for Released Results.

Results that cannot be edited on the Edit Patient Results dialog box are grayed out. Edited results
are flagged with ‘E’. Results calculated from edited results are flagged ‘e’.

1 From the Patient Results screen, select the Edit button to display the Edit Patient Results dialog
box.

Figure 6.30 Edit Patient Results Dialog Box

2 Type in the available text boxes to edit data and select OK.

If the Patient ID or Specimen ID is edited, an E displays in the first position after the result. If the
Patient ID was edited after the result was released, a C displays in the first position.

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Processing Results

Overview
The DxH 800 System Manager includes Flags, Codes and Messages to alert you to issues with patient
or control results. You can also customize the flagging of results and define rules for flagging
sample results.

For instructions on setting up Flagging Limits, refer to Flagging Limits (Menu > Setup > Flagging/
Rules > Flags > Flagging Limits Tab) in the Setup chapter.

CAUTION
Flags, Codes and Messages are evaluated when the sample is analyzed. Flags are
reevaluated when results are manually edited, or when new results are received
for a pending sample. Flags (including Delta Checks) and Decision Rules are not
reevaluated upon a change of flagging limits for results already in the database.
Beckman Coulter Inc. does not claim to identify every abnormality in all samples.
Beckman Coulter suggests using all available options to optimize the sensitivity
of instrument results. All options include:
• Codes
• Flags
• Reference range limits
• Action limits
• Critical limits
• Delta checks
• Definitive messages
• System messages
• Suspect messages
• Status and exception messages
• Decision rules

Beckman Coulter recommends avoiding the use of one type of message or output
to summarize results or patient conditions. There may be situations where the
presence of a rare event may fail to trigger a suspect message.

Look for data patterns when examining Flags, Codes and Messages. For example, determine if some,
all or related sets of results (for example, WBC and differential results) exhibit Flags, Codes and

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Messages. For some parameters, flagging occurs as a result of the flagging or editing of other
parameters. In all cases, follow your laboratory’s policy for reviewing the sample.

CAUTION
Refer to the Limitations section of the System Overview chapter for the interfering
substances that might effect each parameter. Beckman Coulter recommends a
slide review per your laboratory protocol. It is possible that the presence of a rare
event cell can fail to trigger a suspect message.

Customization
You can customize Flags, Codes and Messages to suit the needs of your laboratory. You can define:

• Default reference ranges (high/low limits based on gender, age, location and specimen type)
• Action limits that exceed default reference ranges, or define an action limit alone
• Critical limits that exceed the action limits, or define a critical limit alone
• Definitive messages based on reference ranges, or values manually entered by the lab
• Delta checks
You do not need to define these all at once. You can use the default sets and gradually edit or add
additional limits based on your laboratory’s assessment.

You can also define Decision Rules to identify sample results that meet a set of criteria. For example,
you can automatically generate a Lab Action and/or Comment message such as “Perform Retic
Count” when the System Manager receives a sample result with a HGB < 10.5 and an MCV < 65.

Results can be configured to be held at the Review tab of the Worklist or transmitted to a host, as
well as be selectively printed.

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Flags
Flags appear to the right of the result. For some parameters, flagging occurs as a result of the
flagging or editing of other parameters.

Flags in the following table are shown in order of placement on screens and printouts, with the
highest priority flags at the top within each space.

A yellow background on the screen indicates results were above or below a reference range.
A red background on the screen indicates results exceeded an action or critical limit, or another flag
was present.

Flags appear in one of four positions to the right of the result (as shown in Table 6.1). The flags are
listed in order of priority within each space. It is possible to have flags in each of the four positions.
For some parameters, flagging occurs as a result of the flagging or editing of other parameters.

Table 6.1 Flags

Flag & Position Description

1 2 3 4
E Manual edit of a primary parameter.
e Automatic edit of a calculated parameter.
+ Result above the measuring range.
- Result below the measuring range.
R Review the result.
Special handling is required for editing a result flagged with R. Any parameter
derived from an R-flagged parameter cannot be recalculated until the R-flagged
parameter is edited. R flags may also indicate a System Message has occurred.
Check the message area on the patient result screen and the History Log > General
tab for details.
c L Low critical limit exceeded.
c H High critical limit exceeded.
a L Low action limit exceeded.
a H High action limit exceeded.
H High reference range limit exceeded.
L Low reference range limit exceeded.
P Partial aspiration detected during sample analysis. *
N Non-blood sample detected.*
D Delta check triggered.

* These flags are also associated with System Messages. See the section on System Messages in this
chapter.

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Data Review
Processing Results

Codes
Codes appear in place of results when the system cannot generate results. Codes are also called
non-numeric results.

Codes in the following table are shown in order of placement on screens and printouts, with the
highest priority flags at the top within each space.

Table 6.2 Codes

===== Analysis was disabled at the configuration level of the System Manager (Menu > Setup
> System> Analysis).
For example:
If NRBC is temporarily disabled, any results with an NRBC enumeration in the panel will
display ===== in place of the NRBC values. The ===== persists in the database after
the analysis has been re-enabled.*
xxxxx Although available on a panel, this parameter was not enabled as a Test (Menu > Setup>
Reporting> Tests) at the time of analysis; however, after this analysis, the parameter
was enabled as a Test.
For example:
Sample A was analyzed for a CR panel, but the IRF and MRV were not enabled as Tests.
Later, IRF and MRV were enabled as Tests; therefore, the system will not display the IRF
and MRV parameters for CR panel results, but, for Sample A, xxxxx displays in place of
a value for those parameters.
::::: Flow cell clog was detected.*
----- Total voteout occurred. No average histogram will appear for the affected parameter.
..... Incomplete computation.
May occur in place of calculated parameters because a voteout or overrange occurred
for a primary parameter used in the calculation. Occurs when the instrument cover is
opened.*
+++++ Result exceeds the operating range.
????? Result is outside of the range of values that can be formatted for display.
##### Results were rejected.

*These Codes are also associated with System or System Status Messages. See the sections on
System Message and/or System Status Messages.

6-42 629743AE
Data Review
Processing Results 6

Messages that Appear with Results


Several types of messages are generated on the UniCel DxH 800 along with specimen results:
Suspect, System, Status, Definitive and Exception.

The Suspect, System and Definitive messages display in the Susp/Sys/Def Msgs box just below the
patient demographics at the top of the screen. Suspect messages are red; System Messages are
green; and Definitive messages are blue. Messages are listed alphabetically within their type.

The System Status Messages display below the patient demographics, and to the right of the tabs.
Also displayed in this area are the Exceptions Message, (indicating that an exception has occurred
for this specimen) and the Comment Icon (indicating that there are comments for this specimen).
Exceptions are also displayed on the Additional Data screen.

Suspect
Suspect messages are generated by internal algorithms to convey that a clinical condition may exist
with a specimen based on an abnormal cell distribution or population. Beckman Coulter
recommends the review of results displaying a suspect message appropriate to your patient
population and laboratory practice.

Laboratories may differ in their desired sensitivity to abnormal cell types or patterns. The DxH 800
provides the laboratory with the ability to adjust the sensitivity of several of the Suspect messages,
to meet individual lab requirements. The sensitivity of the following suspect messages can be
adjusted: Variant Lymphs, Left Shift and Immature Granulocytes. Left Shift can also be disabled. In
order to optimize efficiency, Beckman Coulter, Inc. recommends completion of sensitivity and
specificity studies using your sample population prior to adjusting Suspect message flagging
sensitivity.

629743AE 6-43
Data Review
Processing Results

Suspect Message Description


Abnormal Pattern characteristic of specimen with abnormal hemoglobin clearing
Hemoglobin observed during retic analysis
Cellular Inter Pattern consistent with NRBC detection during a CBC only cycle. This Cellular
Interference Suspect message is not associated with a Review (R) flag.
Dimorphic Reds Evidence of the presence of at least two populations of red cells
Giant Platelets Patterns characteristic of specimen containing Giant Platelets
Imm Grans Pattern characteristic of specimen containing: a) metamyelocytes and
myelocytes and/or promyelocytes, or b) myelocytes and/or promyelocytes
without metamyelocytes.
Left Shift Pattern is characteristic of specimen containing metamyelocytes, but without
myelocytes, promyelocytes, or blasts.
LY Blast Blasts in the Lymphocyte region of the dataplot
MO Blast Blasts in the Monocyte region of the dataplot
NE Blast Blasts in the Neutrophil region of the dataplot
NRBC CBC and Diff pattern is characteristic of specimen with NRBCs. This Suspect
message applies when the NRBC analysis is disabled but a CD or CDR cycle is run.
RBC Frag/ The specimen may contain red cell fragments and/or some microcytic red cells
Microcytes
Red Cell Agglut Red cells may be clumped or display rouleaux on peripheral smear
Sickled Cells Pattern characteristic of specimen containing irreversibly sickled cells
Variant LY Pattern characteristic of specimen with variant lymphs, including mature
lymphocytes such as those observed viral infections, as well as immature and/
or abnormal lymphocytes.

System
All System messages are accompanied by R (Review) flags. Exceptions are the System messages
associated with an Aspiration Error (P flag) and the Non-Blood Specimen message (N Flag).

A system message indicates an event occurrence that may affect the operation of the system,
requires operator notification, or entry into a History Log.

System Message Description


Abn Diff Pattern Undefined abnormal Diff pattern observed during Diff analysis.
Abn NRBC Pattern Undefined abnormal NRBC pattern observed during Diff analysis.
Abn RBC Pattern Undefined abnormal RBC pattern observed during CBC analysis.
Abn Retic Pattern Undefined abnormal Retic pattern observed during Diff analysis.
Abn TNC Pattern Undefined abnormal TNC pattern observed during Body Fluid analysis.

6-44 629743AE
Data Review
Processing Results 6

System Message Description


Abn WBC Pattern Undefined abnormal WBC pattern observed during any CBC analysis.
Aged Sample Aged sample detected during Diff analysis.
AL2 Blank Voltage: N AL2 blank voltages out of range during NRBC analysis.
AL2 Blank Voltage: R AL2 blank voltages out of range during Retic analysis.
Bubbles A specific Aspiration Error; P Flag.
Carryover A specific Aspiration Error; P Flag.
Cellular Inter Poor separation between a WBC population and interference. WBC
correction was performed as a best estimation, and the WBC was flagged with
R.
Cover Opened The instrument cover was opened while the specimen was being analyzed.
When the “Cover Opened” event occurs, the SPM immediately stops
operation. The SPM is taken offline. If there was a sample in progress at the
time of the event, the results for that sample sill report as incomplete.
Data Disc: D Flow cell temporarily blocked during Diff data acquisition.
Data Disc: N Flow cell temporarily blocked during NRBC data acquisition.
Data Disc: R Flow cell temporarily blocked during Retic data acquisition.
Excessive Debris The number of debris events too high compared to white events during Diff
analysis.
Excessive Low DC Too many low DC events during NRBC analysis.
Events
Flow Cell Clog: D Hardware detected a flow cell was clogged during Diff analysis.
Flow Cell Clog: N Hardware detected a flow cell was clogged during NRBC analysis.
Flow Cell Clog: R Hardware detected a flow cell was clogged during Retic analysis.
HGB Blank Shift Hgb blank reading was inconsistent with previous values.
High Event Rate: D High data event acquisition rate during Diff analysis.
High Event Rate: N High data event acquisition rate during NRBC analysis.
High Event Rate: R High data event acquisition rate during Retic analysis.
High OP Events: D Too many high OP events during Diff analysis.
High RF Events Too many events with maximum RF during Retic analysis.
Low AL2 Events Too many low AL2 events during NRBC analysis.
Low Event Rate: D Low data acquisition rate during Diff analysis. †
Low Event Rate: N Low data acquisition rate during NRBC analysis. †
Low Event Rate: R Low data acquisition rate during Retic analysis .†
Low Events: D Not enough good Diff events.
Low Events: N Not enough good NRBC events.
Low Events: R Not enough good Retic events.

629743AE 6-45
Data Review
Processing Results

System Message Description


Low Events: PLT Low confidence in MPV, PDW, and PCT due to Low PLT count.
Low OP Events Opacity mode location too low during Retic analysis.
Low RMALS Events RMALS mode location too low during Diff analysis.
MCV Inter: PLT Interference with MCV, RBC, and RDW and RDW-SD due to PLT.
MCV Inter: WBC Low confidence in MCV due to interference from high WBC level.
MO-NE Overlap Population labeled as neutrophils appeared in the monocyte region during
Diff analysis.
NE-EO Overlap Neutrophil and eosinophil populations were shifted or overlapped during
Diff analysis.
No Aspiration A specific Aspiration Error; P Flag.
Non-blood Specimen The blood detector detected that a non-blood specimen was correctly
aspirated. N Flag.
NRBC Interference Interference in NRBC region can't be separated from NRBC during NRBC
analysis.
NRBC-LY Overlap Algorithm could not separate the NRBC and LY populations during NRBC
analysis.
Nucleated Cells Small WBC or NRBC interfered with the Retic analysis (observable on
dataplot).
Partial Aspiration A specific Aspiration Error; P Flag.
Platelet Clumps Pattern is characteristic of specimen containing platelet clumps.
PLT Carryover The estimated PLT carryover, based on the PLT from the preceding sample
and the expected PLT carryover percent, was high enough to significantly
affect the PLT results for the current specimen.
PLT Inter: Debris Interference with smaller platelets.
RBC-PLT Overlap Interference with larger platelets; may occur with the Giant Platelet Suspect
message.
Range Error Blood detector hardware error. Check the History Log.
Retic Inter: Debris The debris population interfered with the Retic measurement.
Retic Inter: PLT The platelet population interfered with the Retic measurement.
RET-RBC Overlap The reticulocytes could not be clearly separated from the mature red cells.
System Event: D Hardware parameters out of limit for some item that could affect Diff
analysis (e.g. voltage, temperature, pressure)
System Event: HGB Hardware parameters out of limit for some item that could affect HGB
analysis (e.g. voltage, temperature, pressure).
System Event: N Hardware parameters out of limit for some item that could affect NRBC
analysis (e.g. voltage, temperature, pressure).
System Event: PLT Hardware parameters out of limit for some item that could affect PLT
analysis (e.g. voltage, temperature, pressure).

6-46 629743AE
Data Review
Processing Results 6

System Message Description


System Event: R Hardware parameters out of limit for some item that could affect Retic
analysis (e.g. voltage, temperature, pressure).
System Event: RBC Hardware parameters out of limit for some item that could affect RBC
analysis (e.g. voltage, temperature, pressure).
System Event: TNC Hardware parameters out of limit for some item that could affect WBC
analysis (e.g. voltage, temperature, pressure).
System Event: WBC Hardware parameters are out of limit for some item that could affect WBC
analysis (e.g., a voltage, temperature, pressure), but results can still be
generated.
TNC Carryover The estimated TNC carryover, based on the uncorrected WBC or TNC from
the preceding sample and the expected TNC carryover percent, was high
enough to significantly affect the TNC results for the current specimen.
Undefined Population A single population was found in the granulocyte region(s) of the dataplot.
Unidentified Events Too many unclassified events were observed during Retic analysis.
Unknown Error A specific Aspiration Error.
WBC Carryover The estimated WBC carryover, based on the uncorrected WBC or TNC from
the preceding sample and the expected WBC carryover percent, was high
enough to significantly affect the WBC results for the current specimen.
WBC Inter: HGB WBC too high for good HGB correction.
WBC Inter: MCV WBC too high for good MCV correction.

† If the acquisition rate is severely affected, the test reports a FULL CLOG (:::::).

Definitive
Definitive messages appear for results based on exceeded limits configured as part of an individual
flagging set. Definitive messages can be created by copying reference ranges, or by manual entry of
your own message definition. Refer to Definitive Messages (Advanced Search Filter Configuration>
Insert> Result> Definitive Messages) in the Setup chapter for instructions.

Some definitive limits can be reported with gradient ranges (1+, 2+, 3+). Limits for definitive
messages with gradients that are defined only at Level 1 (1+) will print without the gradient message
(that is, Microcytosis as opposed to Microcytosis 1+).

629743AE 6-47
Data Review
Processing Results

HGB/HCT Check
The H&H Check Failed is a Definitive Message that can be enabled using the H&H Check button on
the Flagging Limits tab of the Flags Setup screen. Refer to the H&H Check (Menu > Setup > Flagging/
Rules > Flags > Flagging Limits > H&H Check) section of the Setup chapter for instructions.
The values for agreement are defaulted to 3.0. Any value between 2.0 and 4.0 can be entered.

Definitive Message Description


Anemia Low RBC or Low HGB
Basophilia High BA (percentage)
Basophilia# High BA #
Eosinophilia High EO (percentage)
Eosinophilia# High EO #
Erythrocytosis High RBC
Hypochromia (1+, 2+, 3+) Low MCHC
Leukocytosis High WBC
Leukopenia Low WBC
Lymphocytosis# High LY#
Lymphopenia Low LY (percentage)
Monocytosis High MO (percentage)
Monocytosis# High MO#
Neutropenia Low NE (percentage)
Neutrophilia# High NE#
Anisocytosis (1+, 2+, 3+) High RDW
Large Platelets High MPV
Small Platelets Low MPV
Thrombocytopenia Low PLT
Thrombocytosis High PLT
Lymphocytosis High LY (percentage)
Lymphopenia# Low LY#
Macrocytosis (1+, 2+, 3+) High MCV
Microcytosis (1+, 2+, 3+) Low MCV
Neutrophilia High NE (percentage)
Neutropenia# Low NE#
Reticulocytosis High RET
Reticulocytosis# High RET#
NRBCs Present Exceeds defined NRBC

6-48 629743AE
Data Review
Processing Results 6

System Status Messages


System status messages indicate that the instrument was operating in some non-standard state
when a specimen was analyzed. These states are usually the result of some user action (e.g.,
operating with the cover opened). They do not indicate that any problem was seen when the
specimen was analyzed; instead, they indicate that the system was being operated in a manner in
which some problems might not be detected.

System Status Message Description


Interlocks Bypassed The SPM cover interlock was disabled at any time during specimen
analysis. The message IB is displayed on printouts. The message
will display on every screen, print on every display, and be sent
with every transmission until the cover interlock is re-established.
Analysis Disabled: D Diff analysis on the analyzer has been disabled. The message AD: D
is displayed on printout.
Analysis Disabled: N NRBC analysis on the analyzer has been disabled. The message AD:
N is displayed on printout
Analysis Disabled: R Retic analysis on the analyzer has been disabled. The message AD:
R is displayed on printout.
Test Order Nullified The message Null is displayed on printout.
Edit Detected A decision rule was edited after results were posted to the
database. The operator should ensure that a previous decision rule
on unreleased results was not posted in error. The message ED is
displayed on printout.
Specimen Deleted A specimen was deleted from the database while viewing results on the
screen (for example, deleted by the Auto Prune function). Refer to
Database Cleanup (Menu > Setup > System > Database Cleanup) in the
Setup chapter for an explanation of the Auto Prune function.

629743AE 6-49
Data Review
Processing Results

Exception Messages
If there are any exceptions for a specimen, a comments indicator displays in the System Status
Message area below the patient demographics. Select the Additional Data button to view the
Exceptions. The only possible Exceptions for specimens' with results are those that indicate "No"
below Specimen Skipped in the Exception list.

Message Description Specimen Skipped


No Read The Specimen ID could not be read when the Specimen Yes
ID is the primary identifier.
ID Verification Failure The primary and/or secondary identifier, that is read Yes
initially at introduction of the specimen at the mix
station, does not match the primary and/or secondary
identifier read immediately prior to the aspiration of
the specimen.
Cassette Type The Tube Position ID was not read for the first position; Yes
Undetermined consequently the cassette type cannot be determined.
Duplicate Specimen ID An identical specimen ID was read for a second Yes
specimen that has not been released.
Incompatible A body fluid specimen was presented inappropriately in yes
Presentation Mode cassette presentation.
Default Test Order A test order could not be determined, so a No Match No
occurred. A default test order was used for the
specimen. Results available in the Review tab of the
Worklist.
No Match No matching test order could be found on an existing Yes
list of active test orders for a specimen, and there is no
default test order defined.
Specimen ID Reuse A specimen has been seen and the matching test order Yes
has been “Nullified”.
Specimen Skipped A specimen has been skipped after the system Yes
determined that the SPM must be placed offline
because of a previous Specimen Exception or a Fault
Condition.
Secondary ID Mismatch A pre-assigned secondary identifier in test order and a Yes
secondary identifier, read the first time specimen was
seen, don’t match (“mis-match”).
Secondary ID The secondary identifier read for the current run of the Yes
Verification Failure specimen did not match the secondary identifier read
for the previous run of the specimen.
Inconsistent The patient’s name, gender, or DOB changed from the No
Demographics patient’s previously available demographics. Results
available in the Review tab of the Worklist.

6-50 629743AE
Data Review
Release/Reject Results 6

Message Description Specimen Skipped


Non-Studies Specimen A specimen with a matching patient test order was seen Yes
during Studies specimen processing.
Inconsistent Flagging A flagging limit changed after analysis, even though the No
actual flags and messages generated for the results did
not change. This can only occur when specimens are
collated.

Lab Actions
Lab Actions triggered by Decision Rules are listed in the Lab Actions area of the Patient Results
screen. The Lab Actions available as default are as follows:

• Call Physician
• Reflex
• Rerun
• Slide Review
• Verify H&H
NOTE For instructions on setting up operator defined lab actions, refer to Lab Action in the Setup chapter.

Comments
Comments are added by operators as needed. If there are any comments, there will be a comments
indicator in the System Status Message area below the patient demographics. In order to view the
comments, the Comments button must be selected on the Local Navigation bar at the bottom of the
screen.

Release/Reject Results

You can release or reject patient results from the Patient Results screen.

Release Results

Patient Results can be released from the Panels Tab or the Rerun Tab (for the selected), when
"Release" button is selected. There is no Review Tab for the Patient Results screen.

1 Select the Release button on the Patient Results - Review tab to release the results. A DxH dialog
box displays the following: Are you sure you want to release these results? (CDR)

629743AE 6-51
Data Review
Reject Results

2 Select Yes to release the panels,


or
Select No to exit the dialog box without releasing the panels.

Reject Results

Patient Results can be rejected from the Panels tab or the Rerun tab (for the selected), when the
Reject button is selected.

1 Select the Reject button on the Patient Results screen to reject the results. A DxH dialog box
displays the following message: Are you sure you want to reject these selected results?

2 Select Yes to reject the panels,


or
Select No to exit the dialog box without releasing the panels.

View Rejected Results

You can view rejected results on the Custom tab of the Worklist screen by selecting Rejected from
the drop-down list. The Worklist screen shows results as #####. You can view the actual results by
selecting Details on individual samples.

6-52 629743AE
Data Review
Reports 6

Reports

Types
You can manually print three types of reports from the Patient Results screen:

• Chartable Reports
• Laboratory Reports
• Patient Cumulative Reports
Lab Actions display on Laboratory Reports, but not on Chartable Reports. See APPENDIX D for
example reports.

Printing

1 Select the Print icon at the top of the Patient Results screen to display the Print
Specimens Report dialog box.

Figure 6.31 Print Specimens Report Dialog Box

2 Select the report type from the drop-down list and select Print.

629743AE 6-53
Data Review
Reports

Specimen Search

Select the Specimen Search icon to search for patient results by Specimen ID, Tube Position
ID, Patient ID, Last Name, or First Name.

Figure 6.32 Specimen Search Dialog Box

Type in the text boxes and select OK.

6-54 629743AE
CHAPTER 7

Workload

Workload Management

The Workload screen allows you to manage your laboratory’s workload by displaying Workload
statistics such as number of cycles run for specific shifts and the busiest hour.

629743AE 7-1
Workload
Workload Management

Workload Graph view (Menu > Workload > Graph View)


Figure 7.1 Workload -Graph View Screen

NOTE The check boxes that display at the right of the screen vary with the selection in the Workload
Category drop-down list.

7-2 629743AE
Workload
Workload Management 7

Workload Table View (Menu > Workload > Table View)


Figure 7.2 Workload - Table View Screen

NOTE The column headings on the Workload (Table View) screen vary with the selection in the Workload
Category drop-down list. Use the scroll bars at the bottom and to the right of the table to view all of the
data displayed.

Filter Workload by Presentation and Workload Category

1 Select a Presentation method from the drop-down list:


• Cassette
• SIngle Tube
• Both

629743AE 7-3
Workload
Workload Management

2 Select a Workload Category from the drop-down list:


• Patient
• Control
• Calibration
• Repeatability
• Carryover
• Reference
• Studies
• Daily Checks_Shutdown
• Maintenance
• All
NOTE The All and Maintenance categories are for export to .csv file only and can not be viewed in
Table or Graph View.

3 Select a Start Date and an End Date from the drop-down calendars.

4 Select a Shift from the drop-down list.

5 Select from the available check boxes at the right of the screen.

6 Select the Show Labels check box at the bottom of the screen if you want to display labels on the
graph.

7 Select the Refresh button to refresh the screen and display the filtered data.

NOTE If no data matches your selected criteria, the following message displays: There is no data
matching the specified criteria. If you selected Maintenance or ALL in the Workload Category
drop-down list, the following message displays: The category selected is only for exporting data.
Select OK to continue. Refer to the Export Maintenance and ALL Data section of this chapter for
instructions.

7-4 629743AE
Workload
Export Viewable Workload Data 7

Export Viewable Workload Data

You can export all displayed Workload Refer to the Export Maintenance and ALL Workload Data for
instructions on exporting Maintenance and ALL Workload data as a .csv file.

1 Select the Export button at the bottom of the Workload screen. The following DxH message
displays: Are you sure you want to export the displayed workload data?

2 Select OK to export the data or Cancel to end. Selecting OK displays the Select Folder dialog box.

Figure 7.3 Select Folder Dialog Box

3 Select a folder and select OK.

629743AE 7-5
Workload
Export Viewable Workload Data

Export Maintenance and ALL Workload Data


Select Maintenance or ALL data from the Workload Category drop-down list on the Workload screen
to export data to a .csv file.

1 Select Maintenance or ALL from the drop-down list.

2 Make your other selections on the Workload screen and select Refresh. A dialog box displays the
message: The category selected is only for exporting data. Select OK to continue.

3 Select OK.

Figure 7.4 Export QA Data Dialog Box

4 Select a folder on your local drive, name the file, and select Start.

7-6 629743AE
CHAPTER 8

Shutdown

Shutdown Overview

The DxH 800 SPM, System Manager, and Monitor are connected to an Uninterruptible Power Supply
(UPS). In the event of a power outage at your facility, the components will continue to operate for
a short time so that you can shut down the system. If your system has a printer, it should be
connected directly to the facility power.

For troubleshooting purposes, you may be directed to turn off or power down selected pieces of the
system. The following sections provide information on the pieces of the system that you can power
on/off.

NOTE You can power on, or off, the entire system (SPM and System Manager) in any order.

System Manager

Logoff
Log out of the DxH 800 application by logging off the workstation.

Select the Logoff utility icon , then the Exit Workstation button.

Shutdown
The operating system is shutdown by using the routine Windows application.

Power Off
Power off the computer if desired. Powering off the computer also powers off the monitor. You do
not need to power off the monitor separately.

NOTE You do not need to power off the computer or monitor on a regular basis.

629743AE 8-1
Shutdown
Shutdown Overview

SPM

Daily Shutdown
Beckman Coulter recommends that the SPM remain in cleaner for at least 30 minutes every 24
hours. If the SPM has power, the Distribution Valve cycles every 24 hours (timed from the last blood
cycle).

Shutdown can be initiated manually or automatically. Refer to Enable Automatic Shutdown in the
Setup chapter for additional instructions.

Shutdown removes diluent from the UniCel DxH 800 and replaces it with cleaner. At the end of the
time in the cleaner, the cleaner is replaced by diluent. Then, the compressor automatically shuts off.

Manual Shutdown

1 From the Daily Checks screen, select the Shutdown button to display the Manual Shutdown
dialog box.

Figure 8.1 Manual Shutdown Dialog Box

8-2 629743AE
Shutdown
Shutdown Overview 8

2 Select the Perform Startup After Shutdown check box to automatically begin Daily Checks after
Shutdown.

NOTE For information on Daily Checks, refer to the Daily Checks chapter.

3 Type a number in the Time in Cleaner Hours and Minutes check boxes to determine the time in
cleaner.

4 Select OK to begin Shutdown or Cancel to exit the pop-up window without starting Shutdown.

Prolonged Shutdown
Prolonged Shutdown should be performed when the SPM will be idle for over 48 hours, but less than
seven days.
Perform a manual Shutdown by leaving the SPM in cleaner for 30 minutes, then perform Daily
Checks. After a successful Daily Checks, the SPM can be powered off if desired.

Extended Shutdown
Extended Shutdown should be performed when the SPM will be idle for over seven days, but less
than 45 days. Call your Beckman Coulter Representative for assistance with the appropriate actions
to be taken. This could include complete replacement of routine reagents with a specific blend of
reagents designed to maintain the system.

Long Term Shutdown


Long Term shutdown should be performed when the SPM will be in extended storage (greater than
45 days). Call your Beckman Coulter Representative for assistance with the appropriate actions to
be taken. This could include complete removal of all reagents and drying of the system.

Power Off/Power On
The Power Off and Power ON procedures allow you to turn the Electronic Supply module off and on,
on demand. Use this function only when directed by BCI Service Personnel.

Power Off (Menu > Diagnostics > Dx Tools > Common Services)

1 In the Electrical option box, select the Select button and select Power Off from the drop-down
list.

2 Select the Start button to initiate the procedure.

629743AE 8-3
Shutdown
Shutdown Overview

Power On (Menu > Diagnostics > Dx Tools > Common Services)

1 In the Electrical option box, select the Select button and select Power Off from the drop-down
list.

2 Select the Start button to initiate the procedure.

8-4 629743AE
CHAPTER 9

Setup

Overview

This chapter provides the instructions that you need for setting up your DxH 800 System. Many of
the procedures will be performed only occasionally.

Setup System

Operators
and Roles

Flagging/
Rules

Reporting

Controls
XB Setup
Demographics XM Setup
Shifts
Lab Limits
Quality
Control

Communications LIS

Install/Upgrade DxH 800


Software Software Components

Instrument
Hardware System
Information CBC
VCSn
Raw STM
Data SAM
Reagent
Pneumatic

629743AE 9-1
Setup
Set Up Supplies (Menu > Supplies > Setup)

Set Up Supplies (Menu > Supplies > Setup)

You can select the Supply Status icon > Setup to set up supplies.

Configure Containers (Menu > Supplies > Configure Containers)


You can configure the system to run with one diluent container, or two (dual) diluent containers.
The system will automatically switch between two containers if so configured.

Figure 9.1 Configure Containers Dialog Box

1 Select either the Single Container or Dual Container option from the Diluent drop-down list.

2 Select the OK button to save your selection.

9-2 629743AE
Setup
Set Up Supplies (Menu > Supplies > Setup) 9

Configure Low Level Condition (Menu > Supplies > Configure Low Level)
The Configure Low Level option allows you to set a warning level to alert you when a supply is
running low based on the remaining percentage of that supply. Select a percentage from the drop-
down list and select OK.

Figure 9.2 Configure Low Level Dialog Box

The Supplies screen displays the status of the supplies. The Beckman Coulter supplies display
graphically as colored bottles. See Figure 9.3. The colors on the supply screen correlate with the
colors of the consumable connection tubes. See Figure 1.4, SPM Consumable Connections in the
System Overview chapter.

629743AE 9-3
Setup
Set Up Supplies (Menu > Supplies > Setup)

Figure 9.3 Supplies Screen

9-4 629743AE
Setup
Set Up Supplies (Menu > Supplies > Setup) 9

Set Up DxH Supplies(Menu > Supplies > Setup)


The hand-held Bar-code scanner allows you to automatically upload DxH Supply information from
the Setup Supplies dialog box.

Figure 9.4 Setup Supplies Dialog Box

1 With the Setup Supplies dialog box open, scan the bar-codes on the Beckman Coulter reagent
container. The supply information is automatically updated.

2 Select OK to complete the setup, or Next to configure another supply.

629743AE 9-5
Setup
System Setup (Menu > Setup > System)

System Setup (Menu > Setup > System)

You can setup any of the options shown in the local navigation bar of the System screen:

• Backup and Recover


• Database Cleanup
• Printer Setup
• Date and Time
• Barcode Setup
• Audible Alarms
• Studies
• System Configuration
• Analysis
• More: Configure Transport, Aspiration Retry, Remote Management, Set Instrument Name,
Primary Identification

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Setup
System Setup (Menu > Setup > System) 9

Backup and Recover (Menu > Setup > System > Backup and Recover)
The DxH 800 gives you the option of performing a backup for use in case you should ever need to
recover your database. Backups are saved to the removable hard drive that comes with your System
Manager. You can configure an automatic backup or do a manual backup from the Backup and
Recover screen.

CAUTION
Restoration of previous information may negate changes made since the
configuration was last recovered (or the database was last backed up). Please
verify the appropriateness of setup / configuration information before
proceeding.

Figure 9.5 Backup and Recover Screen

629743AE 9-7
Setup
System Setup (Menu > Setup > System)

Configure Automatic Backup (Menu > Setup > System > Backup and Recover > Config Backup)

1 To enable Automatic Backup, select the Enable Automatic Backup check box.

2 Select the frequency for automatic backup from the Frequency drop-down list.

3 Select a time to start automatic backup from the Start Time drop-down list.

4 Select OK.

Perform Manual Backup (Menu > Setup > System > Backup and Recover > Manual Backup)

1 The following warning displays: WARNING: You are about to backup the system to your backup hard
drive. Manual Backups will always overwrite the contents of the backup hard drive. Be sure the correct
hard drive is in place for the backup. Select OK to continue.

2 Select OK to continue with the manual backup.

Database Cleanup (Menu > Setup > System > Database Cleanup)
The Auto prune function allows you to automatically delete patient results that have been in the
database beyond a defined number of days. You can also automatically remove unused pending test
orders from the Worklist. This enhances database performance.

9-8 629743AE
Setup
System Setup (Menu > Setup > System) 9

Figure 9.6 Database Cleanup Dialog Box

1 To automatically prune patient results older than a specified number of days, select the Auto
prune patient results older than check box in the Patient results area of the Database Cleanup
dialog box.

2 Indicate the Time of day to perform the Auto prune.

3 To automatically remove pending test orders older than a specified number of days or hours,
type that number in the Auto remove pending test orders older than text box.

4 Select Days or Hours from the drop-down list.

5 If you selected Days, indicate the Time of day to perform the removal.

629743AE 9-9
Setup
System Setup (Menu > Setup > System)

6 Select OK.

Printer Setup (Menu > Setup > System > Printer Setup)
Figure 9.7 Printer Setup Dialog Box

Set Up the Printer

1 To disable auto print, select the Disable All Auto Printed Reports check box.

NOTE This check box allows you to quickly disable auto printing from any source, in case a printing
problem is encountered.

2 Select a Printer Name from the drop-down list.

3 Select a Paper Size specific to the selected printer from the drop-down list.

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Setup
System Setup (Menu > Setup > System) 9

4 Select a Paper Source from the drop-down list.

5 To print in color, select Color from the Color drop-down list. The system default is to set to print
in black and white.

6 Select the Number of Copies to print for each Patient Results Report Name.

NOTE The value of Number of Copies must be 1 or 2.

7 Select OK.

Date and Time (Menu > Setup > System > Date and Time)
This configuration overrides the operating system date and time.

Figure 9.8 Date / Time Dialog Box

629743AE 9-11
Setup
System Setup (Menu > Setup > System)

1 Select a date format from the Date Format drop-down list, or type a date in the format that
you’ve selected.

2 Select a time format from the Time Format drop-down list.

3 Select a date from the Date drop-down list.

4 Type the time in the Time text box.

NOTE Include AM or PM if your selected Time Format requires that field.

5 Select OK.

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Setup
System Setup (Menu > Setup > System) 9

Bar Code (Menu > Setup > System > Bar-code Setup)
Bar-code setup includes:

• Discover the Bar-code Label Type


• Update the Bar-code Reader Configuration

Discover the Bar-code Label Type


Select Discover Barcode Label Type from the Barcode Procedures drop-down list. A Description
appears on the right hand side of the screen to assist you with the procedure. Messages will display
during and after completion of the procedure; these will indicate the barcode label type.

Figure 9.9 Bar-code Setup and Diagnostics Screen

Update the Bar-code Reader Configuration

1 From the Bar-code Setup and Diagnostics screen Configuration Update section, select the
Enable Fields for Update check box.

NOTE Beckman Coulter recommends that you enable checksum for bar-code labels.

2 Configure the system to read your bar code.

629743AE 9-13
Setup
System Setup (Menu > Setup > System)

3 If you are using interleaved 2 of 5 bar-code labels, type the Number of Characters in the Length
1 text box and the Length 2 text box.

NOTE If the Enable Checksum check box is selected, the numbers should be odd numbers ranging from
three to 21.
If the Enable Checksum check box is not selected, the numbers should be even numbers ranging
from four to 22.

4 Select the Update button to save the configuration.

Audible Alarms (Menu > Setup > System > Audible Alarms)
Audible alarms exist both at the System Manager (Workstation) and at the SPM (Instrument). The
alarms can function independently.

Figure 9.10 Configure Audible Alarms - Workstation Dialog Box

9-14 629743AE
Setup
System Setup (Menu > Setup > System) 9

1 To enable the System Manager’s audible alarm select the Audible Alarm check box on the
Workstation tab.

2 Adjust the volume of the System Manager’s audible alarm using the arrow in the Adjust Volume
panel.

3 To enable the SPM’s audible alarm select the Audible Alarm check box on the Instrument
tab.

4 Use the arrows in the Adjust Volume panel to adjust the volume of the SPM’s audible alarm.

5 Select OK.

629743AE 9-15
Setup
System Setup (Menu > Setup > System)

Studies (Menu > Setup > System > Studies)


Studies allows you to run samples without test orders. The samples are run in a batch process,
without the use of decision rules. Examples of the use of Studies include linearity studies.

In order to use studies, a Default Test Order must be configured and batching must be enabled prior
to enabling studies. Refer to Batching Enabled in this chapter for instructions on enabling batching.

Samples analyzed in Studies contain the leading figures SS- in the Specimen ID or Tube Position ID
field.

NOTE You must be offline to enable Studies.

Figure 9.11 Studies Dialog Box

1 Select the Enable studies check box.

2 To automatically print reports for Studies, select the Auto print lab report for studies check box.

3 To transmit Studies results to a host, select the Transmit to LIS check box.

9-16 629743AE
Setup
System Setup (Menu > Setup > System) 9

4 Select OK.

5 Completed results for Studies samples can be found in the Custom Worklist using the Studies
filter.

NOTE When finished with your Studies, return your system to its normal operating configuration.

Print System Configuration (Menu > Setup > System > System Configuration > Print)
You can obtain a printout of current General System Settings (for example, your barcode
configuration, reporting formats), as well as Control and Decision Rule settings.

Figure 9.12 Print Configuration Dialog Box

Select the appropriate check boxes and then select the Print button.

629743AE 9-17
Setup
System Setup (Menu > Setup > System)

Restore System Configuration (Menu > Setup > System > System Configuration > Restore)
Figure 9.13 Restore Configuration Dialog Box

CAUTION
Restoration of previous information may negate changes made since the
configuration was last restored (or the database was last saved). Please verify the
appropriateness of setup / configuration information before proceeding.

1 Select the Select File button and follow the directions on the screen.

2 To view the restoration file, select the View File button.

3 Select the appropriate Configuration Selection options:


• General System Settings
• Controls
• Decision Rules (Includes Locations and Physicians)

9-18 629743AE
Setup
System Setup (Menu > Setup > System) 9

4 Select the Restore button to restore the selected configuration.

Save System Configuration (Menu > Setup > System > System Configuration > Save)
Saving your system configuration allows you to save the current configuration to a selected
destination, so that it will be available should you need to restore your system configuration to
these settings at some point in the future.

Figure 9.14 Save Configuration Dialog Box

1 Type a file name in the CD Recorder (G:\) File Name text box.

2 Select the appropriate Configuration Selection options, then select the Save button:

629743AE 9-19
Setup
System Setup (Menu > Setup > System)

Temporarily Disable Analysis (Menu > Setup > System > Analysis > Disable Temporarily)
If there is a problem with either the Diff, NRBC or Retic modules, Temporarily Disable Analysis
allows the you to run the SPM without using this module and without generating tests results for
the temporarily disabled analysis.

Figure 9.15 Disable Analysis Temporarily

1 Select the modes of Analysis that you want to disable on the Analysis panel by selecting the
appropriate check box, then select OK:

2 To enable a mode, remove the check from the check box, then select OK. The system will prompt
you to do a system verification when re-enabling modes of Analysis that have been disabled.

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Setup
System Setup (Menu > Setup > System) 9

Permanently Disable Retic Analysis(Menu > Setup > System > Analysis > Disable Permanently)
If you choose not to run Retics in your laboratory, you can disable Retic Analysis in order to save
reagents by running without reticulocyte reagents on your system.

Figure 9.16 Disable Analysis Permanently Dialog Box

1 Select the Retic check box on the Analysis pane and select OK.

NOTE The following warning message will display on a DxH pop-up dialog box:
You have requested to permanently disable an analysis. Please note that disabling Retic
analysis makes it impossible to re-enable it at a future time without a service call.

Any decision rules that use panels containing Retic tests will be disabled.
Any active test orders that include pending Retic tests should be cancelled from the test
orders.
Any individual Retic tests to be disabled should be done manually.
Any reagents related to this analysis should be removed
All panels containing Retic tests will be disabled.

Do you want to continue with this request?

2 Select OK to permanently disable Retic analysis.

629743AE 9-21
Setup
System Setup (Menu > Setup > System)

3 Do the Remove Retic Reagents Procedure (Menu > Diagnostics > Dx Tools > Maintenance)
procedure to remove the reticulocyte reagents from your system.

Set Specimen Primary Identification (Menu > Setup > System > More > Primary Identification)
Set the Specimen ID as your Primary Identifier if you have a bidirectional LIS or use bar coded
specimens. Set Tube Position ID as your Primary Identifier if you do not use bar codes on specimens.

NOTE If Tube Position ID is used, the Tube Position ID labeling must be unique to each cassette used
throughout the lab. Whatever identifier not selected as the Primary Identifier automatically is considered
the Secondary Identifier.

Figure 9.17 Primary Identifier Dialog Box

Select a Primary Identifier from the option buttons, then select OK.

9-22 629743AE
Setup
Set Instrument Name (Menu > Setup > System > More > Set Instrument Name) 9

Set Instrument Name (Menu > Setup > System > More > Set Instrument Name)

Type an Instrument Name and select OK.

Figure 9.18 Configure Instrument Name Dialog Box

Remote Management (Menu > Setup > System > More > Remote Management)

The Remote Management screen is where your system’s hardware is registered with Beckman
Coulter’s ProService. Registration creates an account that allows remote monitoring of your system.
Remote Management, through ProService, can also be used for direct communication with your
system software by Beckman Coulter Service personnel, for troubleshooting services. The Allow
Control Settings give you the ability to never allow the direct communication, always allow it, or
allow it for 24 hours only.

629743AE 9-23
Setup
Remote Management (Menu > Setup > System > More > Remote Management)

Figure 9.19 Remote Management Dialog Box

1 Select an option in the Allow Control Settings option box.

NOTE The Allow Control Settings can be changed as needed after enrollment.

2 Type a number in the Instance Number text box. Service will supply you with the instance
number.

3 Select the Enroll button to enroll.

4 Select the OK button to save the settings.

9-24 629743AE
Setup
Configure Transport 9

Configure Transport

The Configure Transport Settings default to the setting that enables both Cassette and Single-tube
transport. To disable either method of presentation, select the appropriate option on the Configure
Transport Settings dialog box and select OK. If there is a problem with one method of presentation,
you can use this option to disable that presentation method and continue running samples using
the other method of presentation.

Figure 9.20 Configure Transport Settings

629743AE 9-25
Setup
Enable Retry Aspiration (Menu > Setup > System > More > Aspiration Retry)

Enable Retry Aspiration (Menu > Setup > System > More > Aspiration Retry)

Enable this feature if you want the system to automatically retry an aspiration, after an aspiration
error occurs.

Figure 9.21 Enable/Disable Aspiration Retry Dialog Box

Select Enable Retry Aspiration and select OK.

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Setup
Operators and Roles (Menu > Setup > Operators and Roles) 9

Operators and Roles (Menu > Setup > Operators and Roles)

Figure 9.22 Operators and Roles Screen

629743AE 9-27
Setup
Operators and Roles (Menu > Setup > Operators and Roles)

Add a New Operator (Menu > Setup > Operators and Roles > New Operator)
The Lab Administrator can assign operator roles and access level from the Operators and Roles
screen. The password for a new operator is temporary, and the new operator will be prompted to
change the password the first time logon occurs.

Figure 9.23 New Operator Dialog Box

1 Type the appropriate information in the text boxes.

2 Select an Access Level from the drop-down list. Refer to APPENDIX B for a list of Operator Roles
and Access.

3 The Account Status defaults to Active. Change if desired.

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Setup
Operators and Roles (Menu > Setup > Operators and Roles) 9

4 Select OK to create the new operator.

Edit an Existing Operator (Menu > Setup > Operators and Roles > Edit Operator)
The Lab Administrator can edit access levels and account status.

Figure 9.24 Edit Operator Dialog Box

1 Type changes if needed in the text boxes.

2 Select the appropriate Access Level from the drop-down list.

3 Select an Account Status option button.

4 Select OK to save the changes.

629743AE 9-29
Setup
Operators and Roles (Menu > Setup > Operators and Roles)

Reset an Operator’s Password (Menu > Setup > Operators and Roles > Reset Password)
If you forgot your password, an operator at the lab administration level can reset it for you. The new
password is a temporary password and you will be prompted to change you password after logging
on.

Figure 9.25 Reset Password Dialog Box

1 Select the Operator ID.

2 Type the operator’s New Password and type it again in the Confirm Password text box.

NOTE Passwords must be alphanumeric and 3-9 characters in length.

3 Select OK to save the new password.

9-30 629743AE
Setup
Operators and Roles (Menu > Setup > Operators and Roles) 9

Change Your Password (Menu > Setup > Operators and Roles > Change Password)
All operators can change their own password at any time.

Figure 9.26 Change Password Dialog Box

1 Type your Old Password (or the password that was assigned during a reset password procedure).

2 Type your New Password.

3 Type your new password again in the Confirm Password text box.

629743AE 9-31
Setup
Operators and Roles (Menu > Setup > Operators and Roles)

Set Timeout Settings (Menu > Setup > Operators and Roles > Timeout Settings)
A Lab Administrator can determine if your lab will use password expiration or if an inactive screen
will time out after a set time duration (lockout). These settings are optional and are designed to
enhance your security.

Figure 9.27 Timeout Settings Dialog Box

1 To enable Password Expiration (Days), select the Password Expiration (Days) Enabled check box.

2 Select 30, 60, or 90 Days to expiration from the Password Expiration (Days) drop-down list:

3 To enable Auto Lockout, select the Auto Lockout Duration (5-60 minutes) Enabled check box.

4 Type the number of minutes (5-60) in the Auto Lockout duration text box to determine the
amount of time of non-use that will initiate lockout so that the user must log in again.
NOTE If lockout occurs, any user, with the same access level or higher than the previous user, can log
on.

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

5 Select OK to save the new settings.

Flagging and Rules (Menu > Setup > Flagging Rules)

CAUTION
• Flagging Limits, and Delta Checks are evaluated when the sample is analyzed.
• Flagging Limits for Limit Sets and Delta Checks are reevaluated for a sample
when the results are manually edited, or when new results are received for a
pending sample.
• Flagging Limits for Limit Sets, Delta Checks, Sensitivity and Decision Rules are
not reevaluated upon a change of flagging limits for results already in the
database.
Beckman Coulter suggests using all available flagging options to optimize the
sensitivity of instrument results. All flagging options include reference intervals
(H/L), action and critical limits, Definitive, Suspect and System messages,
parameter codes, delta checks, decision rules, and Status and Exception
messages. Beckman Coulter recommends avoiding the use of single messages or
outputs to summarize specimen results or patient conditions.

Flags (Menu > Setup > Flagging/Rules > Flags)


You can set Delta Checks, Flagging Limits, Flagging Sensitivity, and Decision Rules from the Flags
Setup window.

629743AE 9-33
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

Delta Checks (Menu > Setup > Flagging/Rules > Flags > Delta Checks Tab)
Figure 9.28 Delta Checks Tab

Type either the Difference or Percent Difference and Delta Time in the columns in the CBC, DIFF and
Retic panels and select Save.

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

Flagging Limits (Menu > Setup > Flagging/Rules > Flags > Flagging Limits Tab)
Flagging Limits include reference ranges, and definitive, action and critical limits. Flagging Limits
are defined by unique age ranges, specimen type, and can be associated with Location. The system
has seven default sets of limits to use for adults. Only the whole blood range has limits. The Body
Fluids have names only. You can create your own limit sets with unique age ranges.

Figure 9.29 Flagging Limits Tab

Add Flagging Limits

1 From the Flagging Limits Tab, select the Add Limit button on the local navigation bar.

629743AE 9-35
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

Figure 9.30 Flagging Limits Setup - Reference Tab

The Flagging Limits Setup dialog box defaults to the Reference tab view. To view the
Action/Critical, Definitive Male, or Definitive Female tab views, select the corresponding tab.

2 Select a Specimen Type from the drop-down list.

NOTE Selecting a Specimen Type will populate the reference panel with the corresponding tests
for which you can set Flagging Limits, as outlined in the following sections.

3 Type a Limit Name. It must be a different name than the one already on the list.

4 OPTION: Select a Location from the drop-down list or select (+) to add a Location.
For additional instructions on adding a location, refer to the Add a Location section.

5 Select an Age Range (From and To).

NOTE You enter the age range, you can select the View Age Range button to display a graphical view
of the selected range. You can also select View Age Range to view the graphical display when you
get an age range overlap violation.

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

Figure 9.31 Example Age Range Dialog Box

6 To enable this Limit as the system default for this specimen type, select the System Default
check box.

Reference Interval Limits

1 Fill in the empty ranges by typing in the limits or copying the limits from an existing set by
selecting the Copy Limit button.

NOTE For instructions on copying limits, refer to


the Copy Limits section of this chapter.

629743AE 9-37
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

2 Select OK.

Add Action/Critical Limits, Definitive Male, and Definitive Female Limits


To set Action/Critical limits, Definitive Male, and Definitive Female limits select the appropriate tab
on Flagging Limits Setup dialog box and then follow the instructions in the Reference Interval
Limits section of this chapter.

NOTE You can select the Create Definitive Limits button on the Reference Limits tab to copy your Reference
Limits to your Definitive Male and Definitive Female Limits tabs within the same limit set.

H&H Check (Menu > Setup > Flagging/Rules > Flags > Flagging Limits > H&H Check)
The H&H Check is a special definitive flag.

Figure 9.32 H&H Check Dialog Box

1 Select Enable H&H Check to enable H&H check, or deselect the check box to disable H&H check.

2 Type in the text boxes to complete the formula (with any values between 2.0 and 4.0). Default
values are shown in the fields.

3 Select OK.

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

Flagging Sensitivity (Menu > Setup > Flagging/Rules > Flags > Flagging Sensitivity Tab)
Flagging Sensitivity for specific Differential Suspect messages should not be changed unless you
have clinical data supporting the reason for the change.

Figure 9.33 Flags Setup - Flagging Sensitivity Screen

1 Select the High, Medium or Low option buttons to set the sensitivity for Variant Lymphs, Left
Shift and Immature Granulocytes. All Suspect messages are defaulted to high sensitivity.

2 The Left Shift messages can be disabled by deselecting the Left Shift check box.

629743AE 9-39
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

Decision Rules (Menu > Setup > Flagging/Rules > Flags > Decision Rules Tab)
NOTE The instrument must be Offline in order to save Decision Rule changes. If you attempt to save a
Decision Rule that you created while online, your setup information will be lost and must be entered
again.

Decision Rules allow you to define conditions that will initiate system or laboratory follow-up
actions.

CAUTION
You must validate any new decision rules that you add in order to avoid erroneous
results.

The Consensus Rules were created by the ISLH using an international committee of Hematology
experts. If you use the Restore Consensus Rules button, after acknowledging a dialog box, it will post
41 rules, names CR1 to CR41. These rules are Disabled by default. To use a rule as is or to modify it
to conform to your own laboratory policies, you must select and edit it and enable it.

Figure 9.34 Decision Rules Tab

Add a Rule
The Specimen Type drop-down list filters the existing rules by Specimen Type. To add a rule, follow
the steps below.

9-40 629743AE
Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

1 Select the Add Rule button to display the Decision Rule Setup dialog box.

Figure 9.35 Decision Rule Setup Dialog Box

2 Type a Rule Name.

3 Type a Description. (optional)

4 Select a Specimen Type from the drop-down box.

5 Select the Enabled check box to enable the Decision Rule. If you do not enable it now, you can
do so later by editing the rule.

6 Select the Insert button to add If Conditions to the Decision Rule. You can create an If Condition
based on the following:
• Test Result

629743AE 9-41
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

• Test Panels
• Test Flags and Codes
• A Delta Check State
• Suspect Messages
• Definitive Messages
• Exceptions
• A Patient ID
• A Patient’s Age
• A Patient’s Gender
• A Patient’s Ethnicity
• The Specimen Age
• A Physician
• A Location
• A Diagnosis
• A Priority
• A Specimen ID
Select the And, Or, or Nesting button to string together the selected If Conditions.

7 Add an action to your decision rule.


The possible actions that can be added include Lab Actions, Comments, Hold Tests, Rerun,
Reflex, and Stop Processing. One of each type of action in the Then Action panel on the right of
the screen can be included, as follows:
- To add a Lab Action, select a Lab Action.
- To add a Comment, type or select a Comment.
- To Hold Tests, select the Hold Tests check box. These tests are held in the Review tab of the
Worklist.
- To add Additional Tests, select the Rerun check box to request a Rerun. Select a Reflex Panel
from the list to request a Reflex.
- To Stop further rule processing when the specific If Conditions are met, select the Stop
Processing check box.
Refer to Complete the Then Statement for information on how to Add Lab Actions and
Comments.

8 Select OK to save the Decision Rule.

Special Information for If Conditions


The selections available in If Conditions are dependent on the Specimen Type selected. Multiple
conditions can be strung together in one rule.

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

Figure 9.36 Insert If Condition Menu Selections for Whole Blood

Insert Test Result (Decision Rule Setup > Insert > Test Result)
Figure 9.37 Test Result Dialog Box

1 Select a Test Panel from the first drop-down list.

629743AE 9-43
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

2 From the next drop-down list, select an operand from the following options:
• <
• ≤
• >
• ≥

3 To complete the statement, type in the desired value at the bottom of the dialog box, and select
OK.

Insert Panels
Figure 9.38 Panels Dialog Box

1 Select available panels and select the Add button to move the panels to the selected field.

2 Select OK to save your selections. When multiple panels are selected, they will be joined by an
"or".

9-44 629743AE
Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

Insert Test Flags and Codes


Figure 9.39 Test Flags and Codes Dialog Box

1 Select a Test Name from the drop-down list.

2 Select one of the following operands in the Test Flags and Codes drop-down list:
• Equal To
• Not Equal To

3 Select Available Test Flags or Codes and select the Add button.

4 Select OK to save your selections. When multiple panels are selected, they will be joined by an
"or".

629743AE 9-45
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

Insert Delta Check State


Figure 9.40 Delta Check State

1 Select a Test Name.

2 Select a Delta Check State:


• Pass
• Fail
• Not done

3 Select OK.

9-46 629743AE
Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

Insert Suspect, System, Definitive, or Exception Messages


Figure 9.41 Suspect Messages Dialog Box

1 Select one of the operands in the Suspect Messages drop-down list:


• Equal To
• Not Equal To

2 Select Available Suspect Messages and select the Add button to move them to the selected field.

3 Select OK to save your selections. When multiple panels are selected, they will be joined by an
"or".

4 Repeat for any System, Definitive or Exception messages.

629743AE 9-47
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

Insert Patient Information

Insert Patient ID
Figure 9.42 Patient ID Dialog Box

1 Select one of the options in the Patient ID drop-down list:


• Equal To
• Not Equal To
• Not Available

2 If you selected Equal To or Not Equal To, type a value in the text box to complete the conditional
statement.

3 Select OK.

Insert Patient Age


Figure 9.43 Patient Age Dialog Box

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

1 Select an option from the Patient Age drop-down list. The options are:
• <
• ≤
• >
• ≥

2 Type a number and make a unit selection (for example, hours) from the second drop-down list.

3 Select OK.

Insert Patient Gender


Figure 9.44 Patient Gender

1 Select one of the options from the Gender drop-down list:


• Equal To
• Not Equal To

2 In the second drop-down list, select from the following options:


• Unknown
• Male
• Female

3 Select OK.

629743AE 9-49
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

Insert Patient Ethnicity


Figure 9.45 Ethnicity Dialog Box

1 Select one of the options from the Ethnicity drop-down list:


• Equal To
• Not Equal To

2 Select one of the following options from the second drop-down list:
• Unknown
• White
• Black
• Asian/Pacific Islander
• Native American/Alaskan
• Hispanic
• Other

3 Select OK.

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

Insert Specimen Age


Figure 9.46 Specimen Age Dialog Box

1 Select an option from the Specimen Age drop-down list. The options are:
• <
• ≤
• >
• ≥

2 Type a number and make a unit selection from the second drop-down list.

3 Select OK.

629743AE 9-51
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

Insert Physician
Figure 9.47 Ordering Physician Dialog Box

1 Select one of the options from the Ordering Physician drop-down list:
• Equal To
• Not Equal To

2 Select Available physicians and select the Add button to move the Physician to the selected field.

3 Select OK to save your selections.

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

Insert Location
Figure 9.48 Insert Location Dialog Box

1 Select one of options from the Location drop-down list:


• Equal To
• Not Equal To

2 Select Available locations and select the Add button to move the Location to the selected field.

3 Select OK.

629743AE 9-53
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

Insert Diagnosis
Figure 9.49 Diagnosis Dialog Box

1 Select one of the options from the Diagnosis drop-down list:


• Contains
• Does Not Contain

2 Type in the text box to complete the statement and select OK.

Insert Priority
Figure 9.50 Priority Dialog Box

1 Select one of the options from the Priority drop-down list:


• Equal To
• Not Equal To

9-54 629743AE
Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

2 Select one of the following options from the second drop-down list:
• Routine
• Pre-op
• Callback
• ASAP
• STAT

3 Select OK to save your selections.

Insert Specimen ID
Figure 9.51 Specimen ID Dialog Box

1 Select one of the following options from the Specimen ID drop-down list:
• Starts With
• Ends With
• Contains
• Does Not Contain
• Not Available

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

2 Type in the text box to complete the conditional statement and select OK.

Complete the Then Statement

Lab Action

1 Select the Select Lab Action button to suggest an action for the defined If Condition. The Select
Lab Actions dialog box displays.

Figure 9.52 Select Lab Actions Dialog Box

2 Five preset Lab Actions are available. Select a Lab Action and select OK. Otherwise, use Lab
Actions Setup to define your own Lab Actions.

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

Figure 9.53 Lab Actions Setup Dialog Box

3 Select the Add button.

Figure 9.54 Add Lab Action

4 Type a Lab Action in the text box and select OK.

Comments (Menu > Setup > Flagging/Rules > Comments)

1 Select the Add button to display the Add Comment dialog box.

629743AE 9-57
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

Figure 9.55 Add Comment Dialog Box

2 Type a comment in the text box and select OK.

Edit Decision Rules


From the Flags Setup - Decision Rules screen, select a Decision Rule and select the Edit button to
display the Decision Rule Setup dialog box. Follow the instructions for using the Decision Rule Setup
dialog box in the Decision Rules (Menu > Setup > Flagging/Rules > Flags > Decision Rules Tab)
section of this chapter. Use the Delete button to delete conditions if needed.

Copy Decision Rules


From the Flags Setup - Decision Rules screen, select a Decision Rule to copy and select the
Copy Rule button to display the Decision Rule Setup dialog box. Type a new name in the Rule Name
text box and select OK.

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

Restore Decision Rules


From the Flags Setup - Decision Rules screen, select the Restore Rules button to display the Restore
Decision Rules dialog box. The action of restoring Decision Rules will overwrite the existing rules.

Figure 9.56 Restore Decision Rules Dialog Box

629743AE 9-59
Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

Release Rules (Menu > Setup > Flagging/Rules > Release Rules)
You can set Release Rules from the Release Rules dialog box. The selection of Release Rules affects
your ability to write Decision Rules using specific configurations. For example, if your Release Rule
is set to Release all results, then you cannot write a Decision Rule with 'Hold' in the action.

Figure 9.57 Release Rules Dialog Box

1 From the Flagging/Rules screen, select the Release Rules button to display the Release Rules
dialog box.

2 Select one of the following options:


• Hold All Results (All results will be held at the Worklist Review tab.)
• Release All Results (All results can be transmitted to the host. None but Exceptions will be
held at the Worklist Review tab.)
• Release Results Based on Decision Rules (Rules that trigger Decision Rules will be held at the
Worklist Review tab.)

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules) 9

3 Select OK to save your settings.

Physicians (Menu > Setup > Flagging/Rules > Physicians)


This can also be done in Demographics. Refer to Demographics (Menu > Setup > Demographics).

Figure 9.58 Physicians Setup Dialog Box

1 Select the Add button to display the Add Physician dialog box.

Figure 9.59 Add Physician Dialog Box

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

2 Type the appropriate information in the text boxes:


• Physician ID
• Last Name
• First Name
• Middle Name
• Suffix

3 Select the OK button to save.

Locations (Menu > Setup > Flagging/Rules > Locations)


This can also be done in Demographics. Refer to Demographics (Menu > Setup > Demographics).

Figure 9.60 Locations Setup Dialog Box

1 Select the Add button to display the Add Location dialog box.

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Flagging and Rules (Menu > Setup > Flagging Rules) 9

Figure 9.61 Add Location Dialog Box

2 Type a Location in the text box and select the OK button to save.

Auto Stop (Menu > Setup > Flagging/Rules > Auto Stop)
Figure 9.62 Configure Auto Stop Settings Dialog Box

1 From the Flagging/Rules screen, select the Auto Stop button to display the Configure Auto Stop
Settings dialog box.

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Setup
Flagging and Rules (Menu > Setup > Flagging Rules)

2 Select from the following Auto Stop Criteria and type a number in the associated text box:
• No Match
• No Read
• Tube Position No Read
• Partial Aspiration
• Voteouts

3 Select OK to save your settings.

Collation (Menu > Setup > Flagging/Rules > Collation)


Collation enables the addition of a Retic panel to a previously analyzed and released CBC or CD panel
for a specific patient. The Retic panel order that is added must have the same Specimen ID and
Patient ID of the specimen (CBC or CD) released. The SPM must be offline to set this up

Figure 9.63 Collation Dialog Box

1 From the Flagging/Rules screen, select the Collation button to display the Collation dialog box.

2 Select the Auto Collation Enabled check box to enable auto collation.

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Setup
Reporting (Menu > Setup > Reporting) 9

3 Type an Auto Collation Time in the text box and select OK to save.

Reporting (Menu > Setup > Reporting)

Figure 9.64 Reporting Screen

629743AE 9-65
Setup
Reporting (Menu > Setup > Reporting)

Lab Information
You can define the lab information that displays on your reports.

1 From the Reporting screen, select the Lab Information button to display the Laboratory
Information dialog box.

Figure 9.65 Laboratory Information Dialog Box

2 Type in the Field text boxes as needed.

3 Type your IQAP number in the text box if desired.

4 Select OK to save. The Report shown below displays the Report Header that would display based
on the text entered in Figure 9.68.

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Setup
Reporting (Menu > Setup > Reporting) 9

Units Format
The unit formats that are available are JAPAN, SI-1, SI-2, SI-3, SI-4, SI-5,
SI-6, US-1 and US-2. If you choose to Enable Digit for a parameter, your result will display with the
extra decimal place that is shown in brackets, for example [#].

1 From the Reporting screen, select the Units Format button to display the Test Unit Selection
screen in the default Whole Blood view. Select your unit formats from the drop-down list.

Figure 9.66 Test Unit Selection - Whole Blood Screen

2 Select the Body Fluids tab to display the Test Unit Selection - Body Fluids screen and select your
unit format from the drop-down list.

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Setup
Reporting (Menu > Setup > Reporting)

Figure 9.67 Test Unit Selection - Body Fluids Screen

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Setup
Reporting (Menu > Setup > Reporting) 9

Label Names

1 From the Reporting screen, select the Label Names button to display the Label Names dialog
box.

Figure 9.68 Label Names Dialog Box

2 Select the System Name label that you want to define and type a Label Name in the text box.

3 Select OK to save.

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Setup
Reporting (Menu > Setup > Reporting)

Auto Report

1 From the Reporting screen, select the Auto Report button to display the Auto Report Criteria
screen for Patient Results.

Figure 9.69 Auto Report Criteria Screen

2 In the Automatically Report When Results Final Released option box, select from the following
options:
• Lab Report

• Chartable Report

• Cumulative Report

• Transmit Report

3 In the Automatically Report When Results Held option box, select from the following options:
• Lab Report

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Setup
Reporting (Menu > Setup > Reporting) 9

• Chartable Report

4 Select the Print Lab Report As Each Analysis is Completed check box if you want to print reports
after all analyses or the selected analysis completes.

5 If you selected Print Lab Report As Each Analysis is Completed, select from the following
options:
• Print lab report for all results
or

• Only print lab report for abnormal results containing one or more of the following:

— Delta Checks
— Reference Range Flags
— Action Limit Flags
— Critical Limit Flags
— Suspect Messages
— System Messages
— Definitive Messages
— Specimen Exceptions
— Codes
— Instrument Flags
— Decision Rule Triggered

6 Select OK to save your selections.

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Setup
Reporting (Menu > Setup > Reporting)

WBC Options (Menu > Setup > Reporting > WBC Options)
Figure 9.70 WBC Options Dialog Box

Select a reporting option and select OK.

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Setup
Reporting (Menu > Setup > Reporting) 9

Patient Report (Menu > Setup > Reporting > Patient Report)
Figure 9.71 Patient Report Dialog Box

Select reporting options and select OK.

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Setup
Reporting (Menu > Setup > Reporting)

Enable/Disable Tests
From the Reporting screen, select the Tests button to display the Enable/Disable Tests dialog box.

Figure 9.72 Enable/Disable Tests Dialog Box

Select tests to enable or disable and select OK.

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Setup
Reporting (Menu > Setup > Reporting) 9

Auto Report Daily Checks

1 Select the Daily Checks icon at the top of any screen to display the Daily Checks
screen.

2 Select the Auto Report button to display the Daily Checks Auto Report dialog box.

Figure 9.73 Daily Checks Auto Report Dialog Box

3 Select from the following options:


• Enable auto Detail report generation.
• Enable auto Summary report generation.

4 Select OK.

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Setup
Demographics (Menu > Setup > Demographics)

Demographics (Menu > Setup > Demographics)

You can Add or Edit patient demographics information associated with test orders and results.

Figure 9.74 Patient Demographics Screen

Add Patient Demographics

1 Select the Add button to display the Add Patient Demographics dialog box.

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Demographics (Menu > Setup > Demographics) 9

Figure 9.75 Add Patient Demographics Dialog Box

2 Type the Patient’s ID and Name in the text boxes.

NOTE If you use Patient ID, the other information is optional.

3 Select the patient’s Age, Gender, and Ethnicity from the drop-down lists.

4 Type the desired information in the User Fields text boxes.

5 Select the Primary Physician and Patient Location.

6 Type a location in the Location Field text box.

7 Select OK.

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Setup
Demographics (Menu > Setup > Demographics)

Add or Modify a Comment in Patient Demographics

1 Select the Comment button to display the Patient Comment dialog box.

Figure 9.76 Patient Comment Dialog Box

2 Select Add or Edit to display the Add Patient Comment dialog box.

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Demographics (Menu > Setup > Demographics) 9

Figure 9.77 Add Patient Comment Dialog Box

3 Type to add or modify a comment or select a System Comment.

4 Select the Lab Use Only check box if desired.

5 Select OK.

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Setup
Demographics (Menu > Setup > Demographics)

Delete Demographics

1 Select the Delete button to display the Patient Demographics Delete dialog box.

Figure 9.78 Patient Demographics Delete Dialog Box

2 Select an option on the Patient Demographic Delete dialog box and select OK.

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Setup
Demographics (Menu > Setup > Demographics) 9

Edit Patient Demographics


Edit Patient Demographics

1 Select Edit on the Patient Demographics screen to display the Edit Patient Demographics dialog
box.

Figure 9.79 Edit Patient Demographics Dialog Box

2 Type or select the new or modified information and select OK.


To edit the Patient ID, use the Rectify Patient ID button. Refer to the Rectify Patient ID section
for instructions.

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Setup
Demographics (Menu > Setup > Demographics)

Rectify Patient ID

1 Select the Rectify Patient ID button to correct the patient ID associated with a demographic.

Figure 9.80 DxH Dialog Box (Rectify Patient ID)

2 Type the correct patient ID in the text box and select OK. Patient IDs that are rectified for active
orders are flagged with E; those rectified for inactive orders are flagged with C.

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Setup
Quality Control (Menu > Setup > Quality Control) 9

Quality Control (Menu > Setup > Quality Control)

Commercial Controls

1 From any screen, select Menu > Setup > Quality Control to display the Quality Control Setup
screen.

2 Select the Controls tab.

Figure 9.81 Quality Control Setup Screen

629743AE 9-83
Setup
Quality Control (Menu > Setup > Quality Control)

Auto Configure Beckman Coulter, Inc. (BCI) Controls


You can set up the SPM to automatically configure the following BCI Controls:

• COULTER 6C Cell Control

• COULTER LATRON CP-X Control

• COULTER Retic-X Cell Control

• COULTER Body Fluid Control

When the green Refresh icon displays at the top of the screen, select the Refresh button on the Local
Navigation Bar.

1 From the Quality Control Setup - Controls screen, select the Auto Config button to display the
Auto Configure Controls dialog box.

Figure 9.82 Auto Configure Controls Dialog Box

2 Select from the following control option boxes:


• COULTER 6C Cell Control

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Setup
Quality Control (Menu > Setup > Quality Control) 9

• COULTER LATRON CP-X Control


• COULTER Retic-X Cell Control
• COULTER Body Fluid Control

3 Select the OK button to save your selections.

New Patient Control


You can use a patient sample as a control by following the setup procedure below.

1 From the Quality Control Setup - Controls screen, select the New Patient Control button to
display the New Patient Control dialog box.

Figure 9.83 New Patient Control Dialog Box

2 Type a Specimen ID in the text box.

3 Select one of the following test types from the Type drop-down list:
• CBC
• CD
• CDR
• CR
• Retic

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Setup
Quality Control (Menu > Setup > Quality Control)

4 Select a level from the Level drop-down list.

5 Select the Create Control button to display the Create Control dialog box.

Figure 9.84 Create Control Dialog Box

NOTE The parameters that display on the Create Control screen will vary depending on the type of test
that is selected.

6 Select an expiration date from the Expiration Date drop-down list.

7 Select the Auto Transmit check box to automatically transmit control results to your LIS.

8 Select the Auto Stop check box to automatically stop the control run if the limits are out of
range.

9 Select the Auto Print check box to automatically print control run results.

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Setup
Quality Control (Menu > Setup > Quality Control) 9

10 Type a value in the Assigned Target and an Expected Limit text boxes for the parameters that
you want to use for QC flagging.

11 Select the Save button to save the patient control configuration.

New BCI Control from Bar-Code


To set up a new BCI control using the hand-held Bar Code Reader follow the instructions below.

1 From the Quality Control Setup - Controls screen, select the New Control from Bar Code button.
The following message displays: Waiting for 2D bar code to be scanned from assay sheet. Scan the
bar code.

New Manual Entry (BCI Control)

1 From the Quality Control Setup - Controls Tab screen, select the New Manual Entry button to
display the New Manual Entry Control dialog box.

Figure 9.85 New Manual Entry Control Dialog Box

629743AE 9-87
Setup
Quality Control (Menu > Setup > Quality Control)

2 From the New Manual Control Entry dialog box, select a type from the Type drop-down list and
a control level from the Level drop-down list. Then, select the New button to display the Create
Control dialog box.

NOTE If you enter a BCI Control manually and you enter an incorrect Level, Source, or Type, the control
file must be deleted and you must enter the Control again.

Figure 9.86 Create Control (COULTER 6C Cell) Dialog Box

3 Type a Lot Number (without hyphens) and select an Expiration Date from the drop-down list.

CAUTION
Do not use hyphens when typing lot numbers for BCI controls. A hyphen will cause
the control results to be stored as patient results.

4 Select from the options available:


• Auto Transmit
• Auto Stop
• Auto Print

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Setup
Quality Control (Menu > Setup > Quality Control) 9

5 Type the Target and Limit values for the parameters.

6 Select the Save button to save the control settings.

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Setup
Quality Control (Menu > Setup > Quality Control)

Extended QC Setup

1 From the Quality Control Setup screen, select the Extended QC button to display the Extended
QC Setup dialog box.

Figure 9.87 Extended QC Setup - CBC Tab

2 Select the Enable Extended QC check box.

3 Select the tabs to view CBC, DIFF, RETIC, and BFC setup information.

4 Edit the text boxes as needed.

5 Select Save.

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Setup
Quality Control (Menu > Setup > Quality Control) 9

Additional Information in Extended QC Setup


Additional Information allows you to write a comment specific to the Extended QC.

1 From the Extended QC Setup screen, select the Additional Information* button to display the
Additional Information dialog box.

Figure 9.88 Additional Information Dialog Box

2 Type Additional Information if desired and select OK.

Edit Control
To edit Controls, select the Edit Control button on the Quality Control Setup Screen.

629743AE 9-91
Setup
Quality Control (Menu > Setup > Quality Control)

Auto Print Setup

1 From the Quality Control Setup - Controls screen, select the Auto Print Setup button to display
the Auto Print Setup dialog box. (Automatic printing of control file results themselves must be
configured inside the individual control file setup, using the Auto Print check box in the Lot
Information section.)

Figure 9.89 Auto Print Setup Dialog Box

2 Select the Histograms check box to automatically print QC histogram results.

3 Select the Dataplots check box to automatically print QC dataplot results.

4 Select OK to save selected auto print settings.

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Setup
Quality Control (Menu > Setup > Quality Control) 9

IQAP Export
Select the Export IQAP button on the Local Navigation Bar at the bottom of the Quality Control
Setup screen.

Figure 9.90 IQAP Export Dialog Box

XB (Menu > Setup > Quality Control > XB)

1 Select Menu > Setup > Quality Control to display the Quality Control Setup screen.

NOTE To view XB setup, select the XB tab as shown in Figure 9.91, Quality Control Setup- XB Tab.

2 Select the Enable XB on This Instrument check box to enable XB and continue with Step 3.
or
Deselect the Enable XB on This Instrument check box to disable XB and select the Save button.

629743AE 9-93
Setup
Quality Control (Menu > Setup > Quality Control)

Figure 9.91 Quality Control Setup- XB Tab

3 In the Target and Tolerance Settings panel, type a Target value and Limit(%) for MCV, MCH, and
MCHC.

4 In the XB Exclusions group box, select the Exclude check box next to any location that you want
to exclude from XB analysis.

5 In the Reporting Options panel, select the Generate XB Batch Details Report check box if you
want to generate detailed reports.
a. Select one of the following option buttons to determine when the detailed reports print:
• At the completion of each XB batch
• Whenever an XB batch is out (out of range)

b. Select the Levey-Jennings Graphs check box to generate Levey-Jennings graphs with your
details reports.

6 At the bottom of the Reporting Options panel, select the Generate XB Batch Means Report after
every 20 batches check box if you want to generate XB Batch Means reports after every 20
batches.

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Setup
Quality Control (Menu > Setup > Quality Control) 9

a. Select the Levey-Jennings Graphs check box to generate Levey-Jennings graphs with the XB
Batch Means reports.

7 In the XB Alert Settings panel, select one of the following option buttons to determine when the
system generates an XB alert:
• When one batch is out
• When two consecutive batches are out
• When three consecutive batches are out

8 Select the Auto Stop Instrument for XB Alert check box if you want to stop the instrument when
an XB is generated.

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Setup
Quality Control (Menu > Setup > Quality Control)

XM

1 From the Quality Control - XB tab, select the XM tab to display the Quality Control Setup - XM
screen.

Figure 9.92 Quality Control Setup - XM Tab

2 Select the Enable XM on This Instrument check box to enable XM and continue with Step 3.
or
Deselect the Enable XM on This Instrument check box to disable XM and select the Save button.

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Setup
Quality Control (Menu > Setup > Quality Control) 9

3 Select the Parameter Details button to set up Parameter details.

Figure 9.93 Parameter Details - CBC Dialog Box

4 Select the tabs to view CBC, Diff, Retic, and Retic Calc parameter details.

5 Edit the selections as needed.

6 You must configure all the other selections. For example, Reporting Options and Alert Settings.
Refer to XB (Menu > Setup > Quality Control > XB) in this chapter for additional instructions.

7 Select Save before exiting.

629743AE 9-97
Setup
Quality Control (Menu > Setup > Quality Control)

Shifts

1 From the Quality Control Setup screen, select the Shifts tab.

Figure 9.94 Quality Control Setup - Shifts Tab

2 Edit the text boxes as needed and select Save.

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Setup
Quality Control (Menu > Setup > Quality Control) 9

Lab Limits
From the Quality Control Setup screen, select the Limits tab to display the Quality Control - Setup
Lab Limits tab.

Figure 9.95 Quality Control - Lab Limits Tab

1 Select a Source, Type and Level from the drop-down lists.

2 Type the limits in the text boxes and select Save.

629743AE 9-99
Setup
LIS Communications (Menu > Setup > Communications > LIS)

LIS Communications (Menu > Setup > Communications > LIS)

Refer to the Host Transmission Manual that came with your DxH 800 System for the Host
communication data link protocol.

Figure 9.96 LIS Screen

Use the LIS Interface drop-down list to quickly turn the interface off if necessary.

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Setup
Install/Upgrade Software (Menu > Setup > Install/Upgrade Software) 9

Install/Upgrade Software (Menu > Setup > Install/Upgrade Software)

On occasion, your Beckman Coulter Representative may request information regarding software
component status from you over the telephone. The tabbed screens are supplied to help you easily
locate that information.

Figure 9.97 Software Component Versions Screen

629743AE 9-101
Setup
Quality Assurance

Figure 9.98 Software Components Tab

Quality Assurance

Repeatability
Repeatability setup is part of the Repeatability procedure. For instructions on setting up
Repeatability, refer to Repeatability (Menu > QA > Repeatability > Repeatability) in the Quality
Assurance chapter.

Carryover
Carryover setup is part of the Carryover procedure. For instructions on setting up Carryover, refer
to Carryover (Menu > QA > Carryover) in the Quality Assurance chapter.

CBC Calibration
CBC Calibration setup is part of the Calibration procedure. For instructions on setting up CBC
Calibration, refer to Calibration in the Quality Assurance chapter.

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Setup
Quality Assurance 9

Setting Calibration Factors for Routine Calibration

QA Auto Report
Select Menu > Setup > Reporting to display the Reporting screen for Quality Assurance reports
(Repeatability, Carryover and CBC Calibration).

1 Select the QA Auto Report button on the Reporting screen to display the QA Auto Report
Configuration dialog box.

Figure 9.99 QA Auto Report Configuration Dialog Box

2 In the Repeatability option box, if you enable auto report generation, you must also select which
options to print. The options are:
• Enable Auto Report Generation
— Repeatability Summary Report After Procedure is Accepted
— Print Detailed Summary Report After Each Procedure is Completed

3 In the Carryover option box, select both options:


• Enable auto report generation
• Carryover Summary Report after procedure is accepted

629743AE 9-103
Setup
Daily Checks Configuration (Daily Checks > Auto Configuration > Configure Daily checks)

4 In the CBC Calibration option box, If you enable auto report generation, select which option to
report. The options are:
• Calibration Summary Report After the Procedure is Accepted.
• Print Detailed Summary Report After Each Run is Completed.

5 Select OK to save your settings.

Daily Checks Configuration (Daily Checks > Auto Configuration > Configure Daily checks)

Automatic Cycling

Enable Automatic Daily Checks

1 From the Daily Checks screen, select Auto Configuration > Configure Daily checks to display the
Auto Daily Checks Configuration dialog box.

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Daily Checks Configuration (Daily Checks > Auto Configuration > Configure Daily checks) 9

Figure 9.100 Auto Daily Checks Configuration Dialog Box

2 Select Enable Automatic Daily Checks to enable running daily checks automatically on your
system.

3 Select one of the following options:


• Perform Daily Checks After Shutdown
• Perform Daily Checks at a Specified Time

4 If you selected to Perform Daily Checks After Shutdown, select OK to save.


or
If you selected Perform Daily Checks at a Specified Time you must select a time and select a day.
Select OK to save your selections.

Enable Automatic Shutdown

1 From the Daily Checks screen, select Auto Configuration > Configure Shutdown to display the
Auto Shutdown Configuration dialog box.

629743AE 9-105
Setup
Daily Checks Configuration (Daily Checks > Auto Configuration > Configure Daily checks)

Figure 9.101 Auto Shutdown Configuration Dialog Box

2 Select Enable Automatic Shutdown to enable running Shutdown automatically on your system.

3 Complete the following:


• Type the time for automatic shutdown in Hour and Minutes in the text boxes.
• Select AM or PM.
• Select Daily or select specific days of the week to run Shutdown automatically.
• Type the time the cleaner should remain in the SPM during the shutdown procedure in
Hours and Minutes.
• Select OK to save your selections.

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Setup
Default Test Order (Menu > System Status) 9

Default Test Order (Menu > System Status)

The default test order for both Cassette and Single-tube presentations are set on the
System Status screen.

Figure 9.102 System Status Screen

629743AE 9-107
Setup
Default Test Order (Menu > System Status)

Cassette Aspiration Default Test Order

Whole Blood Specimen Type with Test Panel


On the System Status screen, the Automatic(Cassette)-Specimen drop-down list defaults to Whole
Blood.

1 Select the test panel for the default Automatic Test Order from the Test drop-down list:
• None
• CBC
• CD
• CDR
• CR
• H&H
• PLT
• RETIC
• WBC
• WBC-NE#
• WHP

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Setup
Default Test Order (Menu > System Status) 9

Single-tube Aspiration Default Test Order


CSF, Synovial, Pleural, Peritoneal and Pericardial Specimen Types with Test Panel Defaulted
to BFC

1 From the System Status screen, select one of the following specimen types from the Manual-
(Single-tube) Specimen drop-down list:
• CSF
• Synovial
• Pleural
• Peritoneal
• Pericardial

NOTE The Test drop-down list defaults to the BFC test panel for all of the specimen types listed above.

Whole Blood Specimen Type with default Test Panel with Addition of Predilute

NOTE When presenting samples manually, you can run predilute samples with the Whole Blood Specimen
Type as your Default Test Order.

1 Select Whole Blood from the Manual (Single-tube): Specimen drop-down list.

2 Select a Test Panel from the Test drop-down list:


• None
• CBC
• CD
• CDR
• CR
• H&H
• PLT
• PREDILUTE
• RETIC
• WBC
• WBC-NE#
• WHP

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Setup
Batching Enabled

Print Status (System Status > Print Status)


Figure 9.103 Print Status Screen

Batching Enabled

You can use batching when you want to analyze all your specimens with the same default test panel
(for example, your LIS is down). You can enable batching on the SPM from the System Status screen.

1 Select the System Status icon at the top of any screen to display the System Status Screen.

2 Select the Batching Enabled check box to enable batching.

All results will be labeled with the message 'Default Test Order'.

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Setup
Auto Print History Log Configuration 9

Auto Print History Log Configuration

You can schedule when to automatically print portions of the History Logs.

1 Select Auto Print from the History Logs screen.

Figure 9.104 Auto Print Configuration Dialog Box

2 Select a tab:
• Event Logs
• Data Summary Logs
• Audit Logs
• Maintenance Logs

3 Make selections and select OK.

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Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search)

Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search)

You can use the Advanced Search function to write powerful search criteria that will be
implemented through the Custom Worklist. Writing an Advanced Search is similar to writing a
decision rule. Refer to Decision Rules (Menu > Setup > Flagging/Rules > Flags > Decision Rules Tab)
for additional information and instructions.

Figure 9.105 Advanced Search Filter Configuration Dialog Box

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Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search) 9

Rules Triggered (Advanced Search Filter Configuration > Insert > Result > Rules Triggered)
Figure 9.106 Rules Triggered Dialog Box

1 Select an option from the Rules Triggered drop-down list.

2 Select from the Available Rules and select Add.

3 Select OK.

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Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search)

Lab Action (Advanced Search Filter Configuration > Insert > Result > Lab Action)
Figure 9.107 Lab Action Dialog Box

1 Select an option from the Lab Action drop-down list:


• Contains
• Does not contain

2 Type or Select Lab Action.

3 Select OK.

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Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search) 9

Action Status (Advanced Search Filter Configuration > Insert > Status > Action Status)
Figure 9.108 Action Status Dialog Box

1 Select an option from the Action Status drop-down list.

2 Select from the Available list and select Add.

3 Select OK.

Release Status (Advanced Search Filter Configuration > Insert > Status > Release Status)
Figure 9.109 Release Status Dialog Box

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Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search)

1 Select an option from the Release Status drop-down list:


• Equal To
• Not Equal To

2 Select an option from the second drop-down list:


• Not Released
• Partial Released
• Preliminary Release
• Released
• Rejected
• Removed

3 Select OK.

Results Status (Advanced Search Filter Configuration > Insert > Status > Results Status)
Figure 9.110 Results Status Dialog Box

1 Select one of the options from the Results Status drop-down list:
• Equal To
• Not Equal To

2 Select one of the following options from the second drop-down list:
• Pending
• Partially Complete
• Complete

9-116 629743AE
Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search) 9

3 Select OK to save your selections.

Saved Status (Advanced Search Filter Configuration > Insert > Status > Saved Status)
Figure 9.111 Saved Status Dialog Box

1 Select one of the options from the Saved Status drop-down list:
• Equal To
• Not Equal To

2 Select one of the following options from the second drop-down list:
• Not Saved
• Saved

3 Select OK to save your selections.

629743AE 9-117
Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search)

Specimen Status(Advanced Search Filter Configuration > Insert > Status > Release Status)
Figure 9.112 Specimen Status Dialog Box

1 Select one of the options from the Specimen Status drop-down list:
• Equal To
• Not Equal To

2 Select one of the following options from the second drop-down list:
• Pending
• Scheduled
• In Progress
• Partially Complete
• Removed
• Nullified

3 Select OK to save your selections.

9-118 629743AE
Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search) 9

Analysis Date/Time (Advanced Search Filter Configuration > Insert > Specimen
> Analysis/Date Time)
Figure 9.113 Analysis Date/Time Dialog Box

1 Select an Analysis Date/Time and select OK.

629743AE 9-119
Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search)

Draw Date/Time (Advanced Search Filter Configuration > Insert > Patient > Draw Date/Time)
Figure 9.114 Draw Date/Time Dialog Box

Select a Draw/Date Time and select OK.

Presentation (Advanced Search Filter Configuration > Insert > Presentation)


Figure 9.115 Presentation Dialog Box

1 Select an option from the Presentation drop-down list:


• Equal To
• Not Equal To

9-120 629743AE
Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search) 9

2 Select a presentation method from the drop-down list:


• Cassette
• Single Tube

3 Select OK.

Logged Operator ID (Advanced Search Filter Configuration > Insert > Operator > Logged Operator ID)
Figure 9.116 Logged Operator ID Dialog Box

1 Select an option from the Logged Operator ID drop-down list:


• Equal To
• Not Equal To

2 Type an Operator ID in the text box.

3 Select OK.

629743AE 9-121
Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search)

Operator ID (Advanced Search Filter Configuration > Insert > Operator > Operator ID)
Figure 9.117 Operator ID Dialog Box

1 Select an option from the Operator ID drop-down list:


• Equal To
• Not Equal To

2 Type an Operator ID in the text box.

3 Select OK.

Comments (Advanced Search Filter Configuration > Insert > Comments)


Figure 9.118 Comments Dialog Box

9-122 629743AE
Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search) 9

1 Select an option from the Comments drop-down list:


• Contains
• Does not contain

2 Type a comment or Select a Comment.

3 Select OK.

Chartable Report (Advanced Search Filter Configuration > Insert > Report > Chartable Report)
Figure 9.119 Chartable Report Dialog Box

1 Select an option from the Chartable Report drop-down list:


• Equal To
• Not Equal To

2 Select one of the following options from the second drop-down list:
• Not Sent
• Preliminary
• Amended
• Final

3 Select OK.

629743AE 9-123
Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search)

Lab Report (Advanced Search Filter Configuration > Insert > Report > Lab Report)
Figure 9.120 Lab Report Dialog Box

1 Select an option from the Lab Report drop-down list:


• Equal To
• Not Equal To

2 Select one of the following options from the second drop-down list:
• Not Sent
• Preliminary
• Amended
• Final

3 Select OK.

Report Transmitted (Advanced Search Filter Configuration > Insert > Patient > Draw Date/Time)
Figure 9.121 Report Transmitted Dialog Box

9-124 629743AE
Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search) 9

1 Select an option from the Report Transmitted drop-down list:


• Equal To
• Not Equal To

2 Select one of the following options from the second drop-down list:
• Preliminary Not Sent
• Amended Not Sent
• Final Not Sent
• Preliminary Sending
• Amended Sending
• Final Sending
• Preliminary Queued
• Amended Queued
• Final Queued
• Preliminary Sent
• Amended Sent
• Final Sent

3 Select OK.

629743AE 9-125
Setup
Custom Worklist Filter Configuration (Menu > Worklist > Custom Tab > Advanced Search)

9-126 629743AE
CHAPTER 10

Troubleshooting

Precautions / Hazards

Radiation Statement
In the design and manufacture of the DxH 800 System, Beckman Coulter Inc. has complied
with the requirements governing the use and application of a laser as stipulated in regulatory
documents issued by the

• U.S. Department of Health and Human Services, and


• Center for Devices and Radiological Health (CDRH).

In compliance with these regulatory documents, every measure has been taken to ensure the
health and safety of users and laboratory personnel from the possible dangers of laser use.

Laser Safety

WARNING
Possible harm to operator. Do not use any controls, make any adjustments, or perform any
procedures other than those specified herein. To do so may result in hazardous radiation
exposure.

The Multi-transducer Module contains a laser. A laser is a unique light source that exhibits
characteristics different from conventional light sources. The safe use of the laser depends
upon familiarity with the instrument and the properties of coherent, intense beams of light.
The beam can cause eye damage and instrument damage. There is enough power from the laser
to ignite substances placed in the beam path, even at some distance. The beam might also cause
damage if contacted indirectly from reflective surfaces (specular reflection). The laser on the
DxH 800 is covered by a protective housing.

629743AE 10-1
Troubleshooting
Precautions / Hazards

WARNING
Possible harm to operator. Do not attempt to remove the laser or to remove the MTM covers.
Failure to comply can result in hazardous exposure to low radiation. If removal is required, it
must be done only by a Beckman Coulter Representative.

If removal is required, it must be done by a Beckman Coulter Representative.

Laser Warning Labels

WARNING
Possible harm to operator. This instrument contains components dangerous to the operator. If
any attempt has been made to defeat a safety feature, or if this instrument fails to perform as
listed in this manual, disconnect power and call your Beckman Coulter Representative.

CDRH-approved labels are placed near or on those covers that, when removed, might expose
laser radiation.

• Figure 10.1 shows the laser cover and the protective housing cut away. This illustration is
intended only to show you what the system looks like, in compliance with CDRH, with the labels
and their locations on the laser head.

10-2 629743AE
Troubleshooting
Precautions / Hazards 10

Figure 10.1 Laser Warning Label Locations, Protective Housing Cut Away

IVD

Assembly No. Serial No.

xxxxxx
DxH 800 ANALYZER VOLTS 100-240 AMPS 8.0-2.8
Beckman Coulter, Inc.
4300 N. Harbor Blvd. HZ 48-62 WATTS 720
Fullerton, CA 92835 USA

VACUUM
RETIC DIFF NBBC
WASTE 1 WASTE 2 STAIN LYSE STAIN

PRESSURE CLEANER DILUENT 2 DILUENT 1

WASTE SENSOR 1 WASTE SENSOR 2 AVOID EXPOSURE


RETIC
CLEAR
DIFF
PRE
CBC
LYSE
AVOID EXPOSURE
LASER RADIATION IS LASER RADIATION IS
EMITTED FROM THIS APERTURE EMITTED FROM THIS APERTURE

UniC
Cou el Dx AVOID EXPOSURE TO BEAM AVOID EXPOSURE TO BEAM
H 80
CLASS 3B LASER EMISSION
lter
Cell

CLASS 3B LASER PRODUCT


ar Ana
lysis 0
Sys
tem

IEC 60825-1 IEC 60825-1 :2001-8

COHERENT® COHERENT®
27650 SW 95th AVENUE
12840 BILL CLARK WAY
WILSONVILLE, OR 97070
AUBURN, CA 95602-9595
USA (530) (800) 367-7890
USA (530) (800) 367-7890
MFG DATE: XXXXXXX
MFG DATE: XXXXXXX
PN: xxxxxxx REV: xx
xxxxxxx REV. xx
SN: xxxxxx
S/N xxxxxx
OEM - Class 3b product OEM - CLASS IIIb product
DOES NOT COMPLY WITH CDRH
does not comply with CDRH
21CFR 1040.10 and 1040.11
21CFR 1040.10 and 1040.11
CC

629743AE 10-3
Troubleshooting
Precautions / Hazards

EMC Information
This IVD equipment complies with the emission and immunity requirements described in IEC
61326-2-6.

CAUTION
This equipment has been designed and tested to CISPR 11 Class A. In a domestic
environment it could cause interference, in which case, you may need to take
measures to mitigate the interference.
It is advised that prior to the operation of the device, the electromagnetic
environment should be evaluated. Do not use this device in close proximity to
sources of strong electromagnetic radiation. (for example, unshielded intentional
RF sources), as these could interfere with the proper operation.

Disposal of Electrical Instrumentation


It is very important that customers understand and follow all laws regarding the safe and proper
disposal of electrical instrumentation.

The symbol of a crossed-out wheeled bin on the product is required in accordance with the Waste
Electrical and Electronic Equipment (WEEE) Directive of the European Union. The presence of this
marking on the product indicates:

1. The device was put on the European Market after August 13, 2005 and
2. The device is not to be disposed of via the municipal waste collection system of any member
state of the European Union.

A28219-AA

For products under the requirement of the WEEE directive, please contact your dealer or local
Beckman Coulter office for the proper decontamination information and take back program which
will facilitate the proper collection, treatment, recovery, recycling and safe disposal of device.

10-4 629743AE
Troubleshooting
Precautions / Hazards 10

Waste Disposal Warning


Be sure to dispose of waste in accordance with environmental protection regulations.

WARNING
Biohazardous contamination could occur from contact with the waste container
and its associated tubing if not handled with care. Avoid skin contact. Clean up
spills immediately. Dispose of the contents of the waste container in accordance
with your local regulations and acceptable laboratory procedures. Operating the
instrument while the waste level sensor is disconnected can cause biological
contamination. To prevent biological contamination, do not operate the
instrument while the waste level sensor is disconnected.

The maximum waste line length is 3.7 m (12 ft). The waste drain tubing supplied with the system
can be connected to either:
• An open drain, suitable for biohazardous waste, less than 76 cm (30 in.) above the floor
• A waste container with a minimum capacity of 10 L (2.5 gal.)

IMPORTANT When using an open drain instead of a waste container, mechanically secure the waste tube
into the drain, so that the tube cannot accidentally come out of the drain. This prevents spillage.

629743AE 10-5
Troubleshooting
Overview

Overview

General Troubleshooting Techniques

Daily Checks
If Daily Checks are unacceptable, investigate the cause of the failure. Look for red highlighting and
the X icon on tabs. After resolving the cause, repeat Daily Checks.

Diagnostic Procedures
NOTE The SPM must be offline to run diagnostic procedures. If the system is online, the following DxH dialog
box displays: Putting the instrument offline will stop processing specimens and any cassette in progress
will be routed to the output buffer. Do you still want to continue with the request? Select OK to continue
or Cancel to cancel the procedure and remain online

IMPORTANT When you are finished running diagnostics and want to return to online processes, you need
to select the Finish button on the Local Navigation bar at the bottom of the Diagnostics screen.

To access the diagnostic procedures, select Menu > Diagnostics > Dx Tools. The Diagnostic
Procedures screen displays five tabs available for selection: Maintenance, CBC, Diff, SAM, and STM.
Select the Maintenance tab to display the Diagnostic Procedures - Maintenance screen.

10-6 629743AE
Troubleshooting
Overview 10

Figure 10.2 Diagnostic Procedures - Maintenance Screen

Select the tabs to display the Diagnostics Procedures screens for CBC, VCSn, SAM, STM, and
Common Services procedures.

Monitoring the System (Menu > Diagnostics > System Monitor or (F10) )
Press (F10) Access System Monitor from any screen to view the System Monitor screen.

NOTE (F10) Access System Monitor does not function from within dialog boxes.

The module buttons, circled in the figure below, allow you to choose and see functionality from two
modules at one time.

As seen in Figure 10.3, fields on the Voltage, Temperature and Pressure panel display voltage,
temperatures, or pressure readings.

The fields change color to indicate threshold range warnings and errors:

• Red = High Error or Low Error -The reading has surpassed the upper or lower operating error
threshold level.
• Yellow = High Warning and Low Warning - The reading has surpassed an upper or lower
operating warning threshold level.

629743AE 10-7
Troubleshooting
Overview

Gray, green and red dots indicate statuses in various panels. Gray is OFF, green is ON, and an Red
indicates an ERROR. Be aware that the System Monitor screen should be accessed during a
diagnostic procedure, otherwise you might see red (but meaningless) information until the
diagnostic is accessed.
Also, live readings in various fields automatically update during processing. The Local
Navigation bar applies to Diagnostics in general.
As seen in Figure 10.3, VL indicates a valve.

Figure 10.3 System Monitor Screen

10-8 629743AE
Troubleshooting
Overview 10

CBC Panel ( (F10) > CBC and VCSn)


Figure 10.4 System Monitor - CBC and VCSn Panels

629743AE 10-9
Troubleshooting
Overview

STM Panel ( (F10) > STM and SAM)


Figure 10.5 System Monitor - STM and SAM Panels

10-10 629743AE
Troubleshooting
Overview 10

Reviewing Hardware Information (Menu > Setup > Hardware Information)


The Hardware Components Information screens that display on your System Manager are shown in
this section. These screens may be referred to on occasion when communicating with your
Beckman Coulter Representative.

Select Menu > Setup > Hardware Information to display the Hardware Components Information -
Instrument screen. To display the screens for System, CBC, STM, SAM, Reagent and Pneumatic
hardware information, select the corresponding tab.

Figure 10.6 Hardware Components Information - Instrument Screen

629743AE 10-11
Troubleshooting
Individual Troubleshooting Procedures

Individual Troubleshooting Procedures

The troubleshooting procedures in this section are not standard cleaning and replacement
procedures. Some of these procedures require you to access Diagnostic Procedures, while others do
not. For information on cleaning and replacement procedures, refer to the Cleaning and
Replacement chapters of this manual.

Remove a Jammed Cassette


To remove a cassette that is still engaged on the mixer wall, do the following:

1 Remove the Transport Shield. Silence any alarms.

2 Slide the jammed cassette to the right to disengage it from the mixer wall and remove.

3 Replace the Transport Shield.

10-12 629743AE
Troubleshooting
Individual Troubleshooting Procedures 10

Verify Aspiration Probe Alignment (Menu > Diagnostics > Dx Tools > Maintenance)
The Verify Aspiration Probe Alignment procedure moves the aspiration probe and verifies vertical
and horizontal alignment at the target position.

1 Remove the transport shield and lift the front cover.

2 Select Verify Probe Alignment from the drop-down list.

3 Select the Start button to initiate the procedure.

4 The system moves the aspiration probe to a target point on the AMTC. Visually verify that
target is touched by the aspiration probe and select OK.

5 Select Finish.

629743AE 10-13
Troubleshooting
Individual Troubleshooting Procedures

ZAP Apertures Procedure (Menu > Diagnostics > Dx Tools > Maintenance)
The ZAP Apertures procedure applies voltage across RBC and WBC apertures to remove protein
buildup.

The system:

• Drains and rinses the baths.


• Applies the ZAP voltage across the apertures multiple times.
• Monitors and displays the ZAP voltages on the System Monitor screen.

1 Select Zap Apertures from the drop-down list.

2 Select the Start button to initiate the procedure.

3 Press (F10) Access System Monitor and select the Volt/Temp button to view the Zap Aperture
voltages sensor status on the System Monitor.

4 Select Finish.

10-14 629743AE
Troubleshooting
Individual Troubleshooting Procedures 10

HGB Blank Verification Procedure (Menu > Diagnostics > Dx Tools > Maintenance)
The HGB Blank Verification procedure verifies the optical integrity of the HGB channel. The system:

• Drains and rinses the HGB chamber.


• Monitors and displays the HGB output on the System Monitor screen.

NOTE You can end this procedure at any time. When you end this procedure, the lowest and highest HGB
Blank readings are displayed in the Messages box on the Diagnostics Procedures screen.

1 Select HGB Blank Verification from the drop-down list.

2 Select the Start button to initiate the procedure.

3 Press (F10) Access System Monitor and select the Volt/Temp button to view HGB Blank
Verification live data for HGB Blank reading (HGB Output) on the System Monitor.

4 Select Finish.

5 If the procedure passes, repeat Daily Checks if you need to. If the procedure does not pass, call
your Beckman Coulter Representative.

629743AE 10-15
Troubleshooting
Individual Troubleshooting Procedures

Check Pneumatic Supply Procedure (Menu > Diagnostics > Dx Tools > Maintenance)
The Check Pneumatic Supply procedure verifies the stability of the pneumatic supply and checks
the integrity of the pneumatic subsystem and its associated components.

Three procedures are available:

• The Static procedure places the minimum load on the system.


• The Dynamic CNDR procedure simulates a normal CNDR load.
• The Dynamic CBC procedure simulates a normal CBC load.

During both procedures, the system:

• Monitors all pneumatic levels.


• Displays pneumatic levels on the System Monitor screen.

NOTE When you end this procedure, the time (in seconds) for raw pressure and raw vacuum to reach
operating limits is displayed in the Messages box on the Diagnostic Procedures screen.

1 Select Check Pneumatic Supply from the drop-down list.

2 Type a number in the Cycles text box and select the LF (loop on failure) check box if you want
the procedure to continue if a failure occurs.

3 Select the Start button to display the Check Pneumatic Supply dialog box.

Figure 10.7 Check Pneumatic Supply Dialog Box

4 Select from the following options:


• Static - to place the minimum load on the system.

10-16 629743AE
Troubleshooting
Individual Troubleshooting Procedures 10

• Dynamic CNDR - to simulate a normal CNDR load.


• Dynamic CBC - to simulate a normal CBC load.

5 Select the Ok button to start the procedure.

6 Press (F10) Access System Monitor and select the Volt/Temp button to view live readings for Mix,
Sheath, Sample, Raw Pressure, Raw Vacuum, and Count Vacuum on the System Monitor.

629743AE 10-17
Troubleshooting
Individual Troubleshooting Procedures

Check Count Vacuum Procedure (Menu > Diagnostics > Dx Tools > Maintenance)
The Check Count Vacuum procedure verifies the integrity of the low vacuum subsystem. Three
count vacuum procedures are available:

• Procedure 1 does an RBC/WBC count cycle and takes multiple vacuum readings.
• Procedure 2 does an RBC only count cycle and takes multiple vacuum readings.
• Procedure 3 does a WBC only count cycle and takes multiple vacuum readings.

NOTE At the completion of this procedure, the high and low vacuum readings display in the Messages box
on the Diagnostic Procedures screen.

1 Select Check Count Vacuum from the drop-down list.

2 Select the Start button to display the Select Baths dialog box.

Figure 10.8 Select Baths Dialog Box

3 Select one of the following options on the Select Baths dialog box:
• WBC - to do a WBC only count cycle during which multiple readings are taken.
• RBC - to do an RBC only count cycle during which multiple readings are taken.
• Both - to do both a WBC and RBC count cycle during which multiple readings are taken.

4 Press (F10) Access System Monitor and then select the Volt/Temp button to view the Count
Vacuum status on the System Monitor.

5 Do the Set Count Vacuum Regulator Procedure (Menu > Diagnostics > Dx Tools > Maintenance).

10-18 629743AE
Troubleshooting
Individual Troubleshooting Procedures 10

6 Select Finish.

Set Count Vacuum Regulator Procedure (Menu > Diagnostics > Dx Tools > Maintenance)
The Set Count Vacuum Procedure allows you to adjust the Count Vacuum.The System: Places the
SPM in safe mode. Prompts you to adjust the Count Vacuum. Displays the Count Vacuum reading.

• Places the SPM in safe mode.


• Prompts you to adjust the Count Vacuum.
• Displays the Count Vacuum reading.

1 Select Set Count Vacuum from the drop-down list.

2 Select Start.

3 When prompted, remove the transport shield and lift the front cover. Silence any alarms.

4 Locate the Count Vacuum Regulator.

1 2 3 4 5

629743AE 10-19
Troubleshooting
Individual Troubleshooting Procedures

5 Turn the knob at the top of the Count Vacuum Regulator clockwise to raise the pressure or
counter-clockwise to lower the pressure.

6 Press (F10) Access System Monitor and select the Volt/Temp button to view the Count Vacuum
reading on the System Monitor screen.

7 When the adjustment is complete, select Stop to end the procedure.

8 Select Finish.

9 Replace the front cover and the transport shield.

10-20 629743AE
Troubleshooting
Individual Troubleshooting Procedures 10

Remove Retic Reagents Procedure (Menu > Diagnostics > Dx Tools > Maintenance)
The Remove Retic Reagents procedure flushes both Retic reagents out of the system and then dries
the Retic channels.

1 Select Remove Retic Reagents from the drop-down list.

2 Select the Start button.

3 Obtain two 1 liter containers of DI water. Be prepared to refill the containers if needed.

DI H2O

4 Remove pickup tubes from Retic reagent package.


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629743AE 10-21
Troubleshooting
Individual Troubleshooting Procedures

5 Place a single pickup tube in each container of DI water. Do not switch the tubes.

6 Select OK to continue or Cancel to end.

7 If you select OK, the following message displays: System performing Remove Retic Reagent
procedure. Please wait.

8 When the flush portion of the procedure has completed, the following dialog box displays:
Select OK to repeat the flush portion of this procedure or Cancel to proceed to the next step.

9 If you selected Cancel, remove the pickup tubes from the DI water containers and place in a
clean area. Select OK to continue,

10 Select OK to repeat the drying portion of the procedure or Cancel to end.

11 Select Finish.

10-22 629743AE
Troubleshooting
Individual Troubleshooting Procedures 10

Dispense Diluent Procedure (Menu > Diagnostics > Dx Tools > Maintenance)

NOTE Do this procedure after changing the aspiration probe to verify the integrity of the aspiration path.

The Dispense Diluent procedure verifies the integrity of the aspiration path and that the probe
cleaning pump is functional. The system:

1. Extends the manual station.


2. Prompts you to insert an empty tube.
3. Retracts the manual station.
4. Dispenses 1 mL of diluent from the probe cleaning pump, through the aspiration probe, and
into the tube.
5. Extends the manual station again.
6. Prompts you to remove the tube.

1 Select Dispense Diluent from the drop-down list.

2 Select Start to extend the manual station.

3 Place an empty tube in the left position of the manual station to start the procedure.
or
Select Cancel to end the procedure.

4 Upon completion of the procedure, remove the tube from the left position of the manual
station.

5 Select Finish.

629743AE 10-23
Troubleshooting
Individual Troubleshooting Procedures

Prime Sweep Flow Procedure (Menu > Diagnostics > Dx Tools > Maintenance)

The Prime Sweep Flow procedure primes the sweep-flow lines and the chambers behind the RBC
apertures. The system:

1. Drains and rinses the RBC bath.


2. Applies vacuum to the sweep-flow lines.

The system monitors the raw vacuum and raw pressure sensors and displays the sensors’ states on
the System Monitor screen.

1 Select Prime Sweep Flow from the drop-down list.

2 Select the Start button to initiate the procedure.

3 Press (F10) Access System Monitor and select the Volt/Temp button to view the raw vacuum and
raw pressure sensors’ status on the System Monitor - CBC panel.

4 Select Finish.

Cycle DV Procedure (Menu > Diagnostics > Dx Tools > Maintenance)

The Cycle DV procedure verifies the DV motor, clutch, and optical sensors. The system:

• Rotates the DV (distribution valve) to the right and then to the left 10 times, without moving
any liquids.
• Monitors the DV home and DV segment sensors.
• Displays the sensors’ state on the System Monitor screen.

1 Select Cycle DV from the drop-down list.

2 Select the Start button to initiate the procedure.

3 Press (F10) Access System Monitor and select the SAM button to view the sensors’s status on the
System Monitor SAM/Blood Transport panel.

4 Select Finish.

10-24 629743AE
Troubleshooting
Individual Troubleshooting Procedures 10

Unlock DV Procedure (Menu > Diagnostics > Dx Tools > Maintenance)

The Unlock DV procedure helps free the distribution valve when it is frozen and cannot rotate. The
system:

1. Enables the self-clean function for 30 seconds.


2. Waits for 30 seconds.
3. Applies high power to cycle the valve while monitoring the DV home and DV segment sensors.
4. If the sensors do not detect a motion, the system repeats the procedure for a maximum of three
times.

The system displays the sensors’ state on the System Monitor screen.

1 Select Sample to HGB Chamber from the drop-down list.

2 Select the Start button to initiate the procedure.

3 Press (F10) Access System Monitor and select the SAM button to view the sensors’s status on the
System Monitor SAM/Blood Transport panel.

4 Select Finish.

Verify Blood Detectors Procedure (Menu > Diagnostics > Dx Tools > Maintenance)

The Verify Blood Detectors procedure verifies that the air to diluent ratio is appropriate. The
system:
1. Aspirates diluent and takes a blood detector reading.
2. Aspirates air and takes a blood detector reading. (This step is repeated two times.)
3. Displays the diluent and air ratio readings in the message box.

NOTE The ratios of both blood detectors are then stored by the system if they are within the system
specifications.

1 Select Verify Blood Detectors from the drop-down list.

2 Select the Start button to initiate the procedure.

3 When the procedure is complete, select Finish.

629743AE 10-25
Troubleshooting
Individual Troubleshooting Procedures

Flush Flow Cell Procedure (Menu > Diagnostics > Dx Tools > Maintenance)

The Flush Flow Cell procedure is used to clear blockage or flush debris from the flow cell. The flow
cell comprises an upper and lower chamber connected by an aperture.

Four procedures are available:

• The Flush Flow Cell procedure flushes both chambers and flushes the aperture to clear
blockage.
• The Flush Lower Flow Cell procedure flushes the lower chamber only.
• The Flush Upper Flow Cell procedure flushes the upper chamber only.
• The Flush Flow Cell with Cleaner procedure flushes both chambers with cleaner. Then, a timer
allows you to leave the cleaner in the flow cell from 0 - 30 minutes. After the allowed time has
elapsed, the system removes the cleaner from the flow cell and cleans all the areas contacted
by the cleaner.
NOTE If the remove cleaner operation is not successful, the system will not allow any other operation
except remove cleaner.

1 Select Flush Flow Cell from the drop-down list.

2 Select the Start button to initiate the procedure.

Figure 10.9 Flush FlowCell Dialog Box

3 Select a procedure and select OK.

NOTE If you select With Cleaner, a Time in Cleaner text box will display on the Flush Flowcell
dialog box. The default time is 5 minutes. Type your desired time in the cleaner in the text
box and select OK.

10-26 629743AE
Troubleshooting
Individual Troubleshooting Procedures 10

4 Select Finish.

5 Do Daily Checks.

Bar-code Read Rate Procedure (Menu > Diagnostics > Dx Tools > Maintenance > Barcode)

The Bar-code Read Rate Procedure verifies the label symbology, number of digits and characters
and that the bar-code reader is aligned and functional.

The system:

1. Prompts you to place cassettes into the input buffer.


2. Runs the cassettes and reads each bar code, mimicking the SPM cycle.

NOTE Specimen tubes are not pierced.

The system also:

• Displays a running summary identifying read rate for each tube position.
• References Failed Specimen ID reads by cassette sequence number (cassette/position) to allow
for visual examination.

1 Select Barcode Read Rate from the drop-down list.

2 Select the Start button.

3 Place a cassette with bar code labeled specimen tubes in the input buffer to initiate the
procedure.

4 When the procedure is completed, select Finish.

629743AE 10-27
Troubleshooting
Individual Troubleshooting Procedures

Bar-code Alignment Procedure (Menu > Diagnostics > Dx Tools > Maintenance > Barcode)

The Bar-code Alignment procedure automatically aligns the bar-code internal read window to
optimize the read rate.

The system:

1. Prompts you to load a cassette into the input buffer.


2. Runs the cassette and performs 10 reads on each bar code using different angles.

NOTE Specimen tubes are not pierced.

3. Automatically adjusts to the window that provides the best read rate.

1 Select Barcode Alignment from the drop-down list.

2 Select the Start button to initiate the procedure.

3 Place a cassette with bar code labeled specimen tubes in the input buffer to initiate the Bar-code
Alignment procedure.

4 Select OK to continue or Cancel to end the procedure.

5 Select Finish.

Reset SPM Fluidics(Menu > Diagnostics > Dx Tools > Maintenance)

The Reset SPM Fluidics procedure resets the SPM fluidics. The system does the following:

• A power down and power up routine.


• A CNDR diluter cleaning cycle.

1 Select Reset SPM Fluidics from the drop-down list.

2 Select the Start button to initiate the procedure.

3 When the procedure is complete, select Finish.

10-28 629743AE
Troubleshooting
Individual Troubleshooting Procedures 10

Start Pneumatics Procedure(Menu > Diagnostics > Dx Tools > Maintenance)

The Start Pneumatics procedure starts the Pneumatic Supply.

1 Select Start Pneumatics from the drop-down list.

2 Select the Start button to initiate the procedure.

3 When the procedure is complete, select Finish.

LIS Diagnostics (Menu > Diagnostics > LIS)


Figure 10.10 LIS Diagnostics Screen

629743AE 10-29
Troubleshooting
Individual Troubleshooting Procedures

LIS Filter
From the LIS Diagnostics screen, select the Filter button to display the Filter dialog box.

Figure 10.11 Filter Dialog Box

1 Select a Date Range.

2 Select OK.

10-30 629743AE
Troubleshooting
Individual Troubleshooting Procedures 10

LIS Export
From the LIS Diagnostics screen, select the Export button to display the Export dialog box.

Figure 10.12 Export Dialog Box

1 Select the data to export from the Data Selection options.

2 Select a Destination.

3 Select Start.

629743AE 10-31
Troubleshooting
Non-Routine Calibration

Non-Routine Calibration

Some of the screens that display on your System Manager are intended for non-routine testing and
adjusting, or calibration performed by service only. When troubleshooting with a Beckman Coulter
Service Representative by phone, you could be directed to such screen displays for informational
purposes only.

Database Recovery

To successfully restore a database using the DxH 800 Recovery procedure, a backup of the database
must have been performed previously, either by you or the system. To set up automatic or manual
Backup, refer to the Backup and Recover section of the Setup chapter.

To recover a database that has been previously backed up to the C drive of the DxH 800 System,
follow the instructions that follow.

1 Select the Logoff icon from the right-top corner of any screen.

2 Select the Exit Workstation button on the Logoff dialog box.

Figure 10.13 Exit Workstation Dialog Box

3 Select the Exit Workstation option button on the Exit Workstation dialog box.

4 Select OK to close the DxH 800 application and view the Windows desktop.

10-32 629743AE
Troubleshooting
Database Recovery 10

5 Double click the Recover icon on the desktop to start the Recover application.

6 Follow the steps on the DxH 800 Recover dialog box and select the Next button.

NOTE If a database has not been backed up previously using the DxH 800 software, the following
message displays: A Recovery operation cannot be performed because software version XX-
###4 was used to back up the workstation and the current system has software version XX-
###5. Please install software version XX-1234 before performing a Recovery operation.

7 The DxH 800 Recover dialog box displays the following warning: The existing data on the
workstation will be overwritten by the data on the backup hard drive. Be sure the correct hard drive
is inserted in the workstation.

8 Select Recover to begin the recovery operation or Cancel to return to the previous dialog box.
Upon successful recovery a Recovery Successful message displays.

629743AE 10-33
Event Messages from the SPM
10-34

Event Messages from the SPM


Troubleshooting
Error Messages, Warning Messages and Informational Messages from the SPM are listed in the following tables. The Error Messages trigger an
audible and visual alarm. The Warning Messages trigger a yellow visual alarm. The Informational Messages do not trigger an audible or visual
alarm. The tables in this section are: Table 10.1, Error Event Messages, Table 10.2, Warning Event Messages, and Table 10.3, Info Event Messages.

Event Number
The Event Number column in the following tables displays the possible Event Numbers that can display, along with a detailed description of the
event, in the Details box (Menu > Logs > Details). Reviewing the detailed description of an Event Message will help you to understand the event
that occurred. For example, the RBC pump did not sense home event message has two possible Event Numbers associated with it. If the Event
Number is D312007, the detailed message in the Details box will be The RBC pump (PM104) did not sense home when delivering rinse to the Hgb
chamber (VC107) while performing the Analyze Hgb Blank procedure. If the Event Number is D312501, the detailed description will be The RBC
pump (PM104) did not sense home when delivering rinse to the RBC bath (VC150) during the Drain and Rinse CBC procedure.

Action
If the Action column suggests that you review your event messages, refer to APPENDIX C for additional information on how to do this.

Results Affected
The abbreviations in the Results Affected column are defined below:

W WBC
R Retic
D Diff
N NRBC
P PLT
H HGB
629743AE
629743AE

Table 10.1 Error Event Messages

Description Event Probable Cause Action Results Affected


Numbers

CBC Module unable to E_31950 1. CBC Module was unable to proceed due to: Review the detailed message and all events related None.
proceed. D315201 a. Recovery was not successful to this sample or cycle. Follow the troubleshooting
D315221 b. Module did not initialize properly. for the related event.
D315241
c. Problem was detected in Daily Checks,
D337281
Shutdown, or other maintenance cycle.
Cannot move the E_35103 1. Cassette movement was not sensed due to: 1. Remove the transport shield. None.
cassette into or out of D353821 a. Cassette mix DETECT sensor (SN512) or 2. Remove jammed cassette from mixer wall. Refer
the mix station. D353841 electrical connection. to System Help for instructions.
OPERATOR MUST D353861 b. Misalignment of STM XY truck at mix station. 3. Check the platform in front of the mixer for
VERIFY TRANSPORT debris and clean if necessary.
c. Cassette jammed on mixer wall.
AREA IS CLEAR OF
4. Replace the transport shield, and address any
CASSETTES.
warnings or error messages.
Cassette did not E_35106 1. Cassette not loaded on Mixer due to: 1. Check output buffer to see if a cassette was None.
engage the mixer wall. D353862 a. Cassette was loaded backwards. loaded backwards. If so, reload the cassette
OPERATOR MUST b. Misalignment of STM XY truck at mixer correctly in the input buffer.
VERIFY TRANSPORT location. 2. Check area in front of mix station for a lost
AREA IS CLEAR OF cassette.
c. Cassette mix DETECT sensor (SN512) or
CASSETTES. 3. Remove the transport shield.
electrical connection.
4. Remove the lost cassette.
5. Replace the transport shield, and address any
warnings or error messages.
Cassette mixer did not E_35101 1. Cassette mixer movement did not sense home 1. Manually rotate mixer wall up and back (away None.
sense home. D353101 due to: from home) and inspect sensor and indicator. A
a. Misalignment of cassette mixer home red LED indicates the sensor can see the not
position. blocked state. Move the mixer wall home. The
b. Obstruction of mixer movement by a loose flag should block the sensor and the red LED

Event Messages from the SPM


object. should extinguish.
c. Cassette mix HOME sensor (SN510) or 2. Run the Mix Home Alignment procedure. This
electrical connection. procedure automatically measures and stores
the home (vertical) offset position of the mixer

Troubleshooting
d. Cassette mix motor (MT510) or electrical
wall.
connection.
10-35

10
Table 10.1 Error Event Messages (Continued)
10-36

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Cassette mixer missed E_35102 1. Cassette mixer movement missed steps due to: 1. Look for an obstruction on the STM platform that None.
steps while mixing. D353102 a. Obstruction of mixer movement by loose would interfere with mixer wall.
objects. 2. Run the Mix Home Alignment procedure. This
b. Cassette mix motor (MT510) or electrical procedure automatically measures and stores
connection. the home (vertical) offset position of the mixer
wall.
Cassette not sensed on E_35105 1. Cassette was lost due to: 1. Remove the cassette at or near the mix station None.
mixer wall during mix D353501 a. Cassette loaded backwards. and check it for damage.
routine. b. Damaged cassette or mixer wall tongue. 2. If the cassette is damaged discard the cassette.
c. Cassette mix DETECT sensor (SN512) or
electrical connection.
Common Services E_33950 1. Common Services was unable to proceed due Review the detailed message and all events related None.
unable to proceed. D331001 to: to this sample or cycle. Follow the troubleshooting
D333202 a. Recovery was not successful for the related event.
b. Module did not initialize properly.
c. Problem was detected in Daily Checks,
Shutdown, or maintenance cycle.
Could not move E_35411 1. STM pending sensor (SN541) or electrical 1. Remove the transport shield. None.
cassette into or out of D355201 connection. 2. Check for a spill at the pending buffer area.
pending buffer. D355301 3. Remove cassette if present.
OPERATOR MUST D355401
4. Replace the transport shield, and address any
VERIFY TRANSPORT D355501
warnings or errors at the System Manager.
AREA IS CLEAR OF
CASSETTES.
Could not move E_35202 1. Input buffer cassette movement was not sensed 1. Clean the platform at the exit of the input buffer. None.
cassette out of the D352301 due to: Refer to System Help for instructions.
input buffer. OPERATOR a. Dirty platform or cassette. 2. Observe operation. If cassettes move clear of
MUST VERIFY b. STM input CASSETTE 1 sensor (SN521) or input buffer, inspect LED indicators on input
TRANSPORT AREA IS electrical connection. queue sensor PWA. If the sensor is dirty, it could
CLEAR OF CASSETTES. falsely indicate the presence of a cassette.
c. Misalignment of STM XY truck input buffer
location. 3. Clean the sensors. Refer to System Help for
instructions.
629743AE
Table 10.1 Error Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
Could not move the E_35251 1. Output buffer cassette movement was not 1. Remove cassettes and any other loose items. None.
cassette into or out of D354101 sensed due to: Refer to System Help for instructions.
the output buffer. D354301 1. Cassette failed to load on the mixer, and 2. Clean the bottom and sides of the cassette and
D354401 subsequently failed to enter output queue. the platform at the portal of the output buffer.
a. Cassette moved by user. Refer to System Help for instructions.
b. STM output CASSETTE 1 sensor (SN525) or
electrical connection.
Operating position of E_35451 1. STM not sensed in operating position due to: 1. Slide the STM all the way back into operating None.
STM could not be D350082 a. STM in maintenance position. position. Refer to System Help for instructions.
verified. b. STM Operating position sensor (SN545) or 2. Place instrument online.
electrical connection.
SAM unable to E_34950 1. SAM module was unable to proceed due to: Review the detailed message and all events related None.
proceed. D337283 a. Recovery was not successful to this sample or cycle. Follow the troubleshooting
D347001 b. Module did not initialize properly. for the related event.
D347101
c. Problem was detected in Daily Checks.
D347151
D347251 d. Problem was detected in Shutdown.
D347252 e. Problem was detected in a maintenance
D347253 cycle.
STM XY truck did not E_35011 1. STM XY truck did not sense home on the X-axis 1. If the error recurs repeatedly, call your Beckman None.
sense home on the X- D350241 due to: Coulter Representative.
axis. a. Obstruction of STM XY truck movement by
cable routing or a loose object under the
platform.
b. STM X-HOME sensor (SN501) or electrical
connection.
c. STM X-axis motor (MT501) or electrical

Event Messages from the SPM


connection.

Troubleshooting
10-37

10
Table 10.1 Error Event Messages (Continued)
10-38

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
STM XY truck did not E_35021 1. STM XY truck did not sense home on the Y-axis 1. If the error recurs repeatedly, call your Beckman None.
sense home on the Y- D350242 due to: Coulter Representative.
axis. a. Obstruction of STM XY truck movement by a
loose object under the platform or a screw
extending out of the platform.
b. STM Y-HOME sensor (SN502) or electrical
connection.
c. STM Y-axis motor (MT502) or electrical
connection.
d. STM flex cable connection.
STM XY truck E_35012 1. STM XY truck did not sense home on the X-axis None None.
recovered from missed D350243 but recovered due to:
steps on the X-axis. a. Obstruction of STM XY truck movement by
cable routing or a loose object under the
platform.
b. STM X-HOME sensor (SN501) or electrical
connection.
c. STM X-axis motor (MT501) or electrical
connection.
STM XY truck E_35022 1. STM XY truck did not sense home on the Y-axis None None.
recovered from missed D350244 but recovered due to:
steps on the Y-axis. a. Obstruction of STM XY truck movement by a
loose object under the platform or a screw
extending out of the platform.
b. STM Y-HOME sensor (SN502) or electrical
connection.
c. STM Y-axis motor (MT502) or electrical
connection.
d. STM flex cable connection.
STM unable to proceed. E_35950 See Error code. Review the detailed message and all the events in None.
the Error Log with the same activity ID as the
detailed message.
629743AE
Table 10.1 Error Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
Single tube station E_35501 1. Single tube station movement was not sensed 1. Repeatedly enter and exit Manual Presentation None.
home position or tube D351101 due to: to move the single tube station in and out. Note
cradle status could not D351301 a. Obstruction of single tube station if errors recur.
be verified. D351303 movement by cover or cable routing. 2. If errors recur and single tube station is left in the
b. MS Distribution board compromised by load position, manually move the single tube
reagent spill. station to the back position so that Automatic
c. MS HOME sensor (SN550) or electrical presentation can be used.
connection.
d. MS presentation motor (MT550) or electrical
connection.
Transport shield was E_34701 1. Transport shield status was not correct while 1. Close transport shield or front cover. System Event: W, RBC,
opened. D349000 running due to: H, P, N, D, R
a. Transport shield was opened while the
instrument was running.
b. Transport shield SAFE sensor (SN470) or
connection.
Unexpected cassette E_35104 1. Unexpected cassette was sensed but was None. None.
at mix station moved to D353802 removed due to:
output buffer. a. Cassette left on mixer wall.
b. Cassette mix DETECT sensor (SN512) or
electrical connection.
VCSn Module unable to E_32950 1. VCSn Module was unable to proceed due to: Review the detailed message and all events related None.
proceed. D327521 a. Recovery was not successful to this sample or cycle. Follow the troubleshooting
D327541 b. Module did not initialize properly. for the related event.
D327561
c. Problem was detected in Daily Checks.
D327581
D327601 d. Problem was detected in Shutdown.

Event Messages from the SPM


D337282 e. Problem was detected in a maintenance
cycle.

Troubleshooting
10-39

10
Table 10.1 Error Event Messages (Continued)
10-40

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Vacuum chamber drain E_33501 1. Vacuum chamber (VC350) waste drain could not Power off and power on to restart the SPM. None.
did not sense empty. D336041 be verified due to:
a. PRES to vacuum chamber valve (VL360) did
not operate.
b. Leaks or restrictions in the fluidic pathway.
c. Vacuum chamber fluid DETECT sensor
(SN350L) or connection.
Vacuum chamber E_33502 1. Vacuum chamber (VC350) overflows due to. 1. Power off and power on to restart the SPM. System Event: W, RBC,
overflow detected. D336001 a. Overflow from other modules such as 2. Inspect the vacuum trap at the Pneumatic H, P, N, D, R
D336002 Reagent Services, VCS waste chamber Supply module.
(VCS222), RBC count chamber (VC105), 3. If problem continues, call your Beckman Coulter
WBC count chamber (VC106), CBC waste Representative.
chamber (VC115), probe waste chamber
(VC340), sample tank (VC270), or sheath
tank (VC280) into the vacuum chamber
(VC350).
b. Vacuum chamber FULL sensor (SN350H) or
connection.
Vent/overflow chamber E_31991 1. Vent/overflow chamber (VC199) detected 1. Power off and power on to restart the SPM. System Event: W, RBC,
detected overflow. D336201 overflow due to. 2. If problem continues, call your Beckman Coulter H, P, N, D, R
a. Overflow from the Hgb chamber (VC107), Representative.
RBC bath (VC150), WBC bath (VC160), FC
waste chamber (VC218), or diluent feeder
(VC327), into the vent/overflow chamber
(VC199).
b. Vent chamber fluid DETECT sensor (SN199)
or connection.
Vent/overflow chamber E_31992 1. Vent/overflow chamber (VC199) drain could not 1. Power off and power on to restart the SPM. None.
drain did not sense D336221 be verified due to: 2. If problem continues, call your Beckman Coulter
empty. a. Valve VL199 did not operate. Representative.
b. Leak or restrictions in the fluidic pathway.
c. Vacuum at CBC waste chamber (VC115)
unavailable.
629743AE

d. Vent chamber fluid DETECT sensor (SN199)


or connection.
629743AE

Table 10.2 Warning Event Messages

Description Event Probable Cause Action Results Affected


Numbers

Ambient temperature E_33011 1. Ambient temperature exceeded operating limits 1. Check the lab temperature. System Event: W, RBC,
exceeded the D330201 due to 2. Check system fans. H, P, N, D, R
operating limits. a. Lab temperature problem
b. System fans are blocked or inoperative.
c. Ambient temperature sensor (AD301) or
connection.
Blood detector reading E_34804 1. Aspiration path could not be verified before 1. Verify sample path integrity by performing the None.
is approaching the D341291 aspiration and is approaching operating limits Dispense Diluent procedure. - If this fails call
operating limits. D341292 due to: your Beckman Coulter Representative.
D341293 a. Aspiration path restricted or misalignment 2. Perform the Clean Aspiration Probe procedure.
of BSV pads. 3. Perform the Replace Aspiration Probe procedure.
b. Faulty probe cleaning pump operation.
c. Blood detector sensor (BD480) or
connection.
CBC count vacuum is E_31052 1. CBC count vacuum is approaching operating 1. Perform the Static cycle procedure to start None.
approaching the D311642 limits due to pneumatics.
operating limits. a. Count vacuum regulator RG105. 2. Monitor CBC Count Vacuum on the System
b. Leak at aperture housing, sweep flow or Monitor screen using the Volt/Temp tab.
count chamber. 3. Set count vacuum to nominal. If adjustment was
c. Leak or restriction in the count vacuum required, rerun the procedure to verify and
subsystem observe reading for stability.
d. Valves vac/PRES to count chambers VL106,
DISABLE count vacuum VL353.
e. Count vacuum sensor (AD105) or
connection.
Input buffer pushers E_35201 1. Input buffer did not sense home due to: 1. Attempt to recover the system by placing it None.

Event Messages from the SPM


did not sense home. D352001 a. Left and right input buffer pushers not offline, then online again.
synchronized by more than 6.35 mm (0.25 2. If step one failed to recover operational status,
in.) because of slippage or jam. remove all cassettes from the input buffer and
run the Input Buffer Motor Test. Select 10 cycles.

Troubleshooting
b. STM input HOME sensor (SN520) or
electrical connection. If completed without error, return to normal
c. STM input buffer motor (MT520) or electrical operation.
connection.
10-41

10
Table 10.2 Warning Event Messages (Continued)
10-42

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Output buffer is full. E_35254 1. Output buffer full was sensed due to: Remove cassettes from the rear of the output buffer. None.
D354501 a. Cassette left in rear of output buffer.
D354502 b. STM output FULL sensor (SN526) or
D354601 electrical connection.
VCSn phase alignment E_32200 1. VCSn phase alignment did not complete 1. Ensure there is sufficient volume of control to None.
did not complete D321921 successfully due to: repeat the test.
successfully. D321922 a. SCA card did not initialize properly. 2. Ensure that the LATRON CP-X control was
D321923 b. Improper sample transfer to sample line. correctly prepared.
c. Improper aspiration.
d. LATRON CP-X control sample had a problem.
VCSn temperature was E_32404 1. Block temperature exceeded operating limits 1. Check lab's environmental control system. For Block Reaction
not in operating range due to: 2. Check system fans for operation. temperature System
limits. Try again in 10 a. VCSn block peltier (PL240), peltier fans, Event: N, D, R Depends
minutes. system fans, or connection. on the test mode. For
b. Block temperature sensor (AD240) or Stain Temperature
connection. System Event: R For
Mtm Plate Temperature
2. Stain chamber temperature exceeded operating System Event: N, D, R
limits due to: Depends on the test
a. Stain heater, system fans, or connection. mode. For Sample Line
b. Stain temperature sensor (AD260) or Temperature System
connection. Event: N, D, R Depends
on the test mode.
3. Mtm Plate temperature exceeded operating
limits due to:
a. MTM peltier (PL271), peltier fans, system
fans, or connection.
b. Mtm Plate temperature sensor (AD271) or
connection.
4. Sample line temperature exceeded operating
limits due to:
a. Sample line peltier (PL275), peltier fans,
system fans, or connection.
b. Sample line temperature sensor (AD275) or
629743AE

connection.
629743AE

Table 10.3 Info Event Messages

Description Event Probable Cause Action Results Affected


Numbers

A/D or MRC reference E_32901 1. MRC and A/D reference voltages exceeded Go to the System Monitor screen and check live System Event: N, D, R
voltage exceeded the D321421 operating limits due to: status of the monitored parameters. Depends on the test
operating limits. D321441 a. VCSn MRC board parameters out of mode.
D325021 specification
b. MRC reference sensor (AD296) or A/D
reference sensor (AD295) or connections.
A/D or MRC reference E_32902 1. MRC and A/D reference voltages is approaching Go to the System Monitor screen and check live None.
voltage is approaching D321422 operating limits due to: status of the monitored parameters.
the operating limits. D321442 a. VCSn MRC board parameters out of
specification
b. MRC reference sensor (AD296) or A/D
reference sensor (AD295) or connections.
Ambient temperature E_33012 1. Ambient temperature is approaching operating 1. Check the lab temperature. None.
is approaching the D330202 limits due to 2. Check system fans.
operating limits. a. Lab temperature problem
b. system fans are blocked or inoperative.
c. Ambient temperature sensor (AD301) or
connection.
Aspiration error. E_34801 1. Correct sample aspiration could not be verified 1. Check the specimen and ensure: System Event: W, RBC,
D341122 due to: a. The volume was sufficient H, P, N, D, R Aspiration
D341123 a. Insufficient sample. b. It does not contain clots or fibrin. flag.
D341124 b. Aspiration path restricted or compromised. c. It was collected and stored properly.
D341125
c. Probe cleaning pump (PM102). 2. Verify sample path integrity, inspect aspiration
D341126
d. Misalignment of BSV pads. tubing.
e. Blood detector sensor (BD480) or
connection.

Event Messages from the SPM


Troubleshooting
10-43

10
Table 10.3 Info Event Messages (Continued)
10-44

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Aspiration syringe E_34601 1. Aspiration syringe pump (PM460) did not sense Perform the Exercise Aspiration Syringe Pump None.
pump did not sense D340501 home due to: procedure.
home. D343001 a. Faulty aspiration syringe pump (PM460)
drive mechanism.
b. Excessive drag from syringe tip.
c. Aspiration HOME sensor (SN460) or
connection.
d. Aspiration pump motor encoder (EN460) or
connection.
Aspiration syringe E_34603 1. Aspiration syringe pump (PM460) move could Perform the Exercise Aspiration Syringe Pump System Event: W, RBC,
pump move could not D340519 not be verified due to: procedure. H, P, N, D, R Depends
be verified. D340702 a. Aspiration syringe pump (PM460) drive on when the event
D340749 mechanism. occurs.
D341002 b. Excessive drag from syringe tip.
D341009
c. Aspiration encoder (EN460) or connection.
D341016
D341042
D341121
D341508
D341513
D341581
D342507
D342515
D342517
D342525
D343005
629743AE
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
Aspiration syringe E_34602 1. Aspiration syringe pump (PM460) did not sense Perform the Exercise Aspiration Syringe Pump None.
pump sensed home D340502 home but recovered due to: procedure.
after successful D343002 a. Aspiration syringe pump (PM460) drive
recovery. mechanism.
b. Excessive drag from syringe tip.
c. Aspiration HOME sensor (SN460) or
connection.
d. Build up of step tolerance over many cycles
may have caused the 0 position of the
aspiration syringe pump to drift from HOME
sensor.
BSV position could not E_34101 1. BSV did not rotate properly due to: 1. Perform the Cycle BSV procedure. System Event: W, RBC,
be verified. D340510 a. The BSV motor (MT410), 2. Clean the BSV with deionized water and perform H, P, N, D, R Depends
D340681 b. An obstruction, a buildup or poor lubrication the Cycle BSV procedure until functioning on when the event
D341017 due to a self cleaning failure. properly. occurs. Clean Probe:
D341526 None.
c. BSV aspiration position sensor (SN410),
D343010
delivery position sensor (SN411) or
D343011
connections.
Bar-code reader did not E_34081 1. Unable to communicate to bar-code reader due 1. Power off and power on to restart the SPM. None.
read specified label. D341305 to:
a. Poor connection on the SAM MRC board
b. Bar-code reader.
Blood detector reading E_34802 1. Aspiration path could not be verified before 1. Verify sample path integrity by performing the System Event: W, RBC,
exceeded the D341231 aspiration and exceeded operating limits due to: Dispense Diluent procedure. - If this fails call H, P, N, D, R
operating limits. D341232 a. Aspiration path restricted or misalignment your Beckman Coulter Representative.
of BSV pads. 2. Perform the Clean Aspiration Probe procedure.

Event Messages from the SPM


b. Faulty probe cleaning pump operation. 3. Perform the Replace Aspiration Probe procedure.
c. Blood detector sensor (BD480) or
connection.

Troubleshooting
10-45

10
Table 10.3 Info Event Messages (Continued)
10-46

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Blood detector E_34803 1. Aspiration path could not be verified before 1. Verify sample path integrity by performing the System Event: W, RBC,
variance readings D346081 aspiration and exceeded operating limits due to: Dispense Diluent procedure. - If this fails call H, P, N, D, R
exceeded the D346082 a. Aspiration path restricted or misalignment your Beckman Coulter Representative.
operating limits. D346083 of BSV pads. 2. Perform the Clean Aspiration Probe procedure.
D346084 b. Faulty probe cleaning pump operation. 3. Perform the Replace Aspiration Probe procedure.
c. Blood detector sensor (BD480) or
connection.
CBC count vacuum E_31051 1. CBC count vacuum exceeded operating limits 1. Perform Check Count Vacuum procedure. System Event: W, RBC,
exceeded the D311641 due to P
operating limits. a. Count vacuum regulator RG105.
b. Leak at aperture housing, sweep flow or
count chamber.
c. Leak or restriction in the count vacuum
subsystem
d. vac/PRES to count chambers valve VL106,
or DISABLE count vacuum valve VL353.
e. Count vacuum sensor (AD105) or
connection.
CBC diluent E_31111 1. CBC bath temperature exceeded operating 1. Check the lab temperature. None.
temperature exceeded D311621 limits due to: 2. Check system fans.
the operating limits. a. Temperature problem in the lab
b. System fans are blocked or inoperative.
c. CBC bath temperature sensor (AD111) or
connection.
CBC diluent E_31112 1. CBC bath temperature is approaching operating 1. Check the lab temperature. None.
temperature is D311622 limits due to: 2. Check system fans.
approaching the a. Temperature problem in the lab.
operating limits. b. System fans are blocked or inoperative.
c. CBC bath temperature sensor (AD111) or
connection.
CBC lyse pump E_31012 1. CBC lyse pump (PM101) did not rotate properly. Perform the Sample to Hgb chamber procedure. System Event: W, H
delivery could not be D312507
629743AE

verified.
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
CBC lyse pump did not E_31011 1. CBC Lyse pump did not verify that it was home Perform the Sample to Hgb chamber procedure. System Event: W, H
sense home. D312506 due to:
a. CBC lyse pump (PM101) did not rotate
properly.
b. CBC lyse HOME sensor (SN101) or
connection.
CBC waste chamber E_31151 1. CBC waste did not drain due to 1. Access the System Monitor screen, select CBC For Deliver Cbc:
drain did not sense D311001 a. Fluidic restriction at output ENABLE CBC and Common Serv tabs. System Event: W,
empty. D312505 waste valve VL114. 2. Under sensors, in the CBC section, check the RBC,H, P For Drain and
b. Problem associated with the CBC waste vac/ Waste Chamber indicator. It should be blank. If it Rinse CBC : None.
PRES valve VL115. is green, see online help.
c. Leak/restriction in the pneumatic or fluidic
pathway.
d. CBC waste fluid DETECT sensor (SN115) or
connection.
DC or RF flow cell E_32903 1. DC or RF voltage exceeded operating limits due Go to the System Monitor screen and check live System Event: N, D, R
voltage exceeded the D321461 to: status of the monitored parameters. Depends on the test
operating limits. D321481 a. Flow cell clog. mode.
b. Air in aperture.
c. DC or RF flow cell voltage fault.
d. DC (AD290) or RF (AD294) flow cell voltage
sensor or connection.
DC or RF flow cell E_32904 1. DC or RF voltage is approaching operating limits Go to the System Monitor screen and check live None.
voltage is approaching D321462 due to: status of the monitored parameters.
the operating limits. D321482 a. Flow cell clog.
b. Air in aperture.

Event Messages from the SPM


c. DC or RF flow cell voltage fault.
d. DC (AD290) or RF (AD294) flow cell voltage
sensor or connection.

Troubleshooting
Diff lyse pump delivery E_32052 1. Diff lyse pump (PM205) did not rotate properly. From the Diagnostic Procedures menu, select System Event: D
could not be verified. D322004 Common Services > Fluidic > Prime Diff Lyse.
10-47

10
Table 10.3 Info Event Messages (Continued)
10-48

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Diff lyse pump did not E_32051 1. Diff lyse pump did not sense home due to: From the Diagnostic Procedures menu, select System Event: D
sense home. D322003 a. Diff lyse pump (PM205) did not rotate Common Services > Fluidic > Prime Diff Lyse.
properly.
b. Diff lyse HOME sensor (SN205) or
connection.
Diff preservative pump E_32042 1. Diff preservative pump (PM204) did not rotate From the Diagnostic Procedures menu, select System Event: D
delivery could not be D322006 properly. Common Services > Fluidic > Prime Diff
verified. Preservative.
Diff preservative pump E_32041 1. Diff preservative pump did not sense home due From the Diagnostic Procedures menu, select System Event: D
did not sense home. D322005 to: Common Services > Fluidic > Prime Diff
a. Diff preservative pump (PM204) did not Preservative.
rotate properly.
b. Diff preservative HOME sensor (SN204) or
connection.
Distribution valve did E_32003 1. Distribution valve (DV200) did not sense proper From the Diagnostic Procedures menu, select VCSn System Event: N, D, R
not report expected D320704 rotation due to > Mechanical > Cycle DV. Depends on the test
position. D320708 a. Problem with DV motor (MT400), or mode.
D322302 connection.
D322309 b. DV binding,
D323205
c. DV position sensors (SN400, SN401) or
D324504
connections.
D324704
Distribution valve did E_32001 1. Distribution valve (DV200) did not sense home From the Diagnostic Procedures menu, select VCSn System Event: N, D, R
not sense home. D320701 due to >Mechanical > Unlock DV. Depends on the test
D323201 a. Problem with DV motor (MT400) or mode.
D324701 connection.
b. DV binding,
c. DV position sensor (SN400) or connection.
Distribution valve E_32002 1. Distribution valve (DV200) did not sense home None. None.
home recovered. D320702 but recovered due to
D323202 a. Problem with DV motor (MT400) or
D324702 connection.
b. DV binding.
629743AE

c. DV position sensor (SN400) or connection.


Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
Distribution valve E_32004 1. Distribution valve (DV200) did not sense proper None. None.
recovered expected D320705 rotation but recovered due to
position. D320709 a. Problem with DV motor (MT400) or
D322303 connection.
D322310 b. DV binding.
D323206
c. DV position sensors (SN400, SN401) or
D324505
connections.
D324705
Electronic Supply E_33055 1. One or more Electronic Supply module current 1. Check to ensure that the three fans are on. None.
module current D332182 measurement +5VIA, +12VIA, -12VIA, 24VIA 2. Verify voltages on System Monitor screen from
exceeded the D332202 exceeded operating limits due to: the Volt / Temp tab.
operating limits. D332222 a. Electronic Supply module voltage fault
D332262 b. Defective component/assembly connected
to the Electronic Supply module. (i.e. SPI
bus, PS fan)
c. 5VIA MON sensor (AD390), (+)12VIA MON
sensor (AD391),
(-)12VIA MON sensor (AD392), 24VIA MON sensor
(AD394), or connection.
1. Laser power supply current exceeded operating
limits due to:
a. Problem with Laser. (I.e. end of life.)
b. Laser IA sensor (AD395) or connection.

Event Messages from the SPM


Troubleshooting
10-49

10
Table 10.3 Info Event Messages (Continued)
10-50

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Electronic Supply E_33054 1. One or more Electronic Supply module current 1. Check to ensure that the three fans are on. None.
module current is D332181 measurement +5VIA, +12VIA, -12VIA, 24VIA is 2. Verify voltages on System Monitor screen from
approaching the D332201 approaching operating limits due to: the Volt / Temp tab.
operating limits. D332221 a. Electronic Supply module voltage fault
D332261 b. Defective component/assembly connected
D332281 to the Electronic Supply module. (i.e. SPI
bus, PS fan)
c. 5VIA MON sensor (AD390), (+)12VIA MON
sensor (AD391),
(-)12VIA MON sensor (AD392), 24VIA MON sensor
(AD394), or connection.
1. Laser power supply current is approaching
operating limits due to:
a. Problem with Laser. (I.e. end of life.)
b. Laser IA sensor (AD395) or connection.
Electronic Supply E_33053 Electronic Supply module Service/Normal SERVICE Call your Beckman Coulter Representative. None.
module in service D332003 DETECT sensor (SN374) switch in Service mode.
mode.
629743AE
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
Electronic Supply E_33052 1. One or more Electronic Supply module voltage 1. Check to ensure that the three fans are on. None.
module voltage D332022 +5V, +12V, -12V, 24V, or Raw HV exceeded 2. Verify voltages on System Monitor screen from
exceeded the D332042 operating limits due to: the Volt / Temp tab.
operating limits. D332082 a. Voltage drifted.
D332102 b. Defective component/assembly connected
D332122 to the Electronic Supply module. (i.e. SPI
D332142 bus, PS fan)
D332162
c. Regulated HV sensor (AD381), 5V MON
sensor (AD382), (+)12V MON sensor
(AD383), (-)12V MON sensor (AD384), 24V
MON sensor (AD386) or connection.
2. HV voltage exceeded operating limits due to
a. Problem with CBC Transducer I/F board.
b. Defective component/assembly connected
to the HV. (i.e. aperture)
c. Raw HV sensor (AD380) or connection.
3. Power supply AdRefV voltage exceeded
operating limits due
a. Problem with CBC Transducer I/F.
b. Electrical Power Supply A/D ref sensor
(AD387) or connection.

Event Messages from the SPM


Troubleshooting
10-51

10
Table 10.3 Info Event Messages (Continued)
10-52

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Electronic Supply E_33051 1. One or more Electronic Supply module voltage 1. Check to ensure that the three fans are on. None.
module voltage is D332021 +5V, +12V, -12V, 24V, or Reg HV is approaching 2. Verify voltages on System Monitor screen from
approaching the D332041 operating limits due to: the Volt / Temp tab.
operating limits. D332081 a. Voltage drifted
D332101 b. Defective component/assembly connected
D332121 to the Electronic Supply module. (i.e. SPI
D332141 bus, PS fan)
D332161
c. Regulated HV sensor (AD381), 5V MON
sensor (AD382), (+)12V MON sensor
(AD383), (-)12V MON sensor (AD384), 24V
MON sensor (AD386) or connection.
2. Raw HV voltage is approaching operating limits
due to
a. Problem with CBC Transducer I/F board.
b. Defective component/assembly connected
to the raw HV. (i.e. aperture)
c. Raw HV sensor (AD380) or connection.
3. Power supply AdRefV voltage is approaching
operating limits due
a. Problem with CBC Transducer I/F.
b. Electronic Power Supply A/D ref sensor
(AD387) or connection.
Flow cell DC voltage E_32101 1. Flow Cell Clog detected due to: From the Diagnostic procedures menu select VCSn > System Event: N, D, R
exceeded the expected D321005 a. Cellular debris or trapped particle. Fluidic > Flush Flow Cell. Select the With Cleaner Depends on the test
range. Possible full b. Air in line. option. Set time to 5 minutes. mode.
clog.
629743AE
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
Hgb blank exceeded E_31801 1. Hgb Blank Voltage exceeded operating limits 1. Perform Hgb Blank Verification procedure. System Event: H
the operating limits. D312021 due to 2. Perform Daily Checks.
D312061 a. Hgb chamber (VC107) did not drain with
D312081 valve (VL107)
b. Hgb chamber (VC107) did not fill with valve
(VL104)
c. RBC/Hgb pump (PM104).
d. Improper cleaning of Hgb transfer line due
to valves VL167, and VL136.
e. Leak/restriction in the pneumatic or fluidic
pathway.
f. Hgb lamp or Hgb chamber (VC107) optical
problem.
g. Hgb blank voltage (AD180) sensor or
connection.
2. Hgb lamp drive voltage exceeded operating
limits due to
a. Lamp or drive voltage.
b. Hgb drive voltage (AD183) sensor or
connection.
3. Hgb lamp drive current exceeded operating
limits due to
a. Lamp or drive voltage.
b. Hgb drive current (AD182) sensor or
connection.

Event Messages from the SPM


Troubleshooting
10-53

10
Table 10.3 Info Event Messages (Continued)
10-54

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Hgb blank is E_31802 1. Hgb Blank Voltage is approaching operating 1. Perform the Hgb Blank Verification procedure. None.
approaching the D312022 limits due to 2. Perform Daily Checks.
operating limits. D312062 a. Hgb chamber (VC107) did not drain with
D312082 valve (VL107)
b. Hgb chamber (VC107) did not fill with valve
(VL104)
c. RBC/Hgb pump (PM104).
d. Improper cleaning of Hgb transfer line due
to valves VL167, and VL136.
e. Leak/restriction in the pneumatic or fluidic
pathway.
f. Hgb lamp or Hgb chamber (VC107) optical
problem.
g. Hgb blank voltage (AD180) sensor or
connection.
2. Hgb lamp drive voltage s approaching operating
limits due to
a. Lamp or drive voltage.
b. Hgb drive voltage (AD183) sensor or
connection.
3. Hgb lamp drive current s approaching operating
limits due to
a. Lamp or drive voltage.
b. Hgb drive current (AD182) sensor or
connection.
Initial Aspiration error. E_34805 1. Correct sample aspiration could not be verified 1. Check the specimen and ensure: None.
due to: a. The volume was sufficient
a. Insufficient sample. b. It does not contain clots or fibrin.
b. Aspiration path restricted or compromised. c. It was collected and stored properly.
c. Probe cleaning pump (PM102). 2. Verify sample path integrity, inspect aspiration
d. Misalignment of BSV pads. tubing.
e. Blood detector sensor (BD480) or
connection.
629743AE
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
Input buffer pushers E_35203 1. Input buffer pushers missed steps due to: 1. Remove all cassettes from the input buffer. None.
missed steps during a D352002 a. Left and right input buffer pushers not 2. Access Menu > Diagnostics > Dx Tools > STM >
sweep. synchronized by more than 6.35 mm (0.25 Motor Tests. Select In buffer Motor Test. Type 4 in
in.) because of slippage or jam. the Cycles text box and select the LF (Loop on
b. Loose belt. Failure) option. Monitor the message box for
c. STM input buffer motor (MT520) or electrical reported skipped steps.
connection. 3. Call your Beckman Coulter Representative.
d. STM input HOME sensor (SN520) or
electrical connection.
Light scatter offset E_32905 1. LS offset voltage exceeded operating limits due Go to the System Monitor screen and check live System Event: N, D, R
exceeded the D321501 to: status of the monitored parameters. Depends on the test
operating limits. D321521 a. Flow cell clog. mode.
D321541 b. Air in aperture.
c. Misaligned or dirty flow cell.
d. LMALS offset sensor (AD291), UMALS offset
sensor (AD292),
ALL offset sensor (AD293) or connections.
Light scatter offset is E_32906 1. LS voltage is approaching operating limits due Go to the System Monitor screen and check live None.
approaching the D321502 to: status of the monitored parameters.
operating limits. D321522 a. Flow cell clog.
D321542 b. Air in aperture.
c. Misaligned or dirty flow cell.
d. LMALS offset sensor (AD291), UMALS offset
sensor (AD292),
ALL offset sensor (AD293) or connections.

Event Messages from the SPM


Mix pressure exceeded E_32621 1. Mix pressure exceeded operating limits due to: 1. Perform Check Pneumatic procedure, select System Event: N, D, R
the operating limits. D320714 a. Faulty mix pressure regulator (RG362) Static cycle and adjust as needed. Depends on the test
D323209 b. Leak. mode.
D324205
c. Mix pressure sensor (AD362) or connection.

Troubleshooting
10-55

10
Table 10.3 Info Event Messages (Continued)
10-56

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Mix pressure is E_32622 1. Mix pressure is approaching operating limits due 1. Perform Check Pneumatic procedure, select None.
approaching the D320715 to: Static cycle and adjust as needed.
operating limits. D323210 a. Faulty mix pressure regulator (RG362)
D324206 b. Leak.
c. Mix pressure sensor (AD362) or connection.
NRBC lyse pump E_32012 1. NRBC lyse pump (PM201) did not rotate From the Diagnostic Procedures menu, select System Event: N
delivery could not be D322008 properly. Common Services > Fluidic > Prime NRBC Lyse.
verified.
NRBC lyse pump did E_32011 1. NRBC Lyse pump did not sense home due to: From the Diagnostic Procedures menu, select System Event: N
not sense home. D322007 a. NRBC lyse pump (PM201) did not rotate Common Services > Fluidic > Prime NRBC Lyse.
properly.
b. NRBC lyse HOME sensor (SN201) or
connection.
One or more Flow cell E_32102 1. One or more Flow cell parameter exceeded From the Diagnostic procedures menu select VCSn > System Event: N, D, R
parameters exceeded D321003 operating limits due to: Fluidic > Flush Flow Cell. Select the Both option. Depends on the test
operating limits. a. Partial aperture clog due to cellular debris or mode.
trapped particle.
b. Misalignment of the MTM.
c. Air in line.
629743AE
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
Pneumatic Supply E_33062 1. Pneumatic Supply module raw pressure 1. Verify proper operation of Pneumatic Supply None.
module exceeded the D333022 exceeded operating limits due to: module by inspecting the front panel LEDs.
operating limits. D333042 a. Compressor not operating to specification. Confirm both LEDs are green.
(cooling fan, 24V , or control circuit failure.) 2. Perform Check Pneumatic procedure Static
b. 60-psi bleed regulator RG301 option. Observe raw pressure and vacuum and
c. 25-psi regulator RG302 adjust as necessary.
d. PRES to vacuum chamber valve VL360
e. Leak or restriction in the Pneumatic Supply
module or the SPM.
f. Raw pressure sensor (AD361) or connection.
2. Pneumatic Supply module raw vacuum
exceeded operating limits due to:
a. Compressor not operating to specification.
(cooling fan, 24V , or control circuit failure.)
b. DISABLE raw vacuum valve VL356
c. Leak or restriction in the Pneumatic Supply
module or the SPM. (i.e. vacuum trap VC311
)
d. Raw vacuum sensor (AD351) or connection.

Event Messages from the SPM


Troubleshooting
10-57

10
Table 10.3 Info Event Messages (Continued)
10-58

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Pneumatic Supply E_33061 1. Pneumatic Supply module raw pressure is 1. Verify proper operation of Pneumatic Supply None.
module is approaching D333021 approaching operating limits due to module by inspecting the front panel LEDs.
the operating limits. D333041 a. Compressor not operating to specification. Confirm both LEDs are green.
(cooling fan, 24V , or control circuit failure.) 2. Perform Check Pneumatic procedure Static
b. 60-psi bleed regulator RG301 option. Observe raw pressure and vacuum and
c. 25-psi regulator RG302 adjust as necessary.
d. PRES to vacuum chamber valve VL360
e. Leak or restriction in the Pneumatic Supply
module or the SPM.
f. Raw pressure sensor (AD361) or connection.
2. Pneumatic Supply module raw vacuum is
approaching operating limits due to
a. Compressor not operating to specification.
(cooling fan, 24V , or control circuit failure.)
b. DISABLE raw vacuum valve VL356
c. Leak or restriction in the Pneumatic Supply
module or the SPM. (i.e. vacuum trap VC310
)
d. Raw vacuum sensor (AD351) or connection.
Possible tube bottom E_34204 1. False bottom tube or improper tube bottom 1. Check tube types and ensure they are in the None.
detected before D341034 calibration. correct cassettes.
expected. D341084 2. Probe does not move properly due to: 2. Perform Extend/Retract Probe procedure.
D341085 a. Probe motor (MT420) or connection. 3. Remove cover and check for obstruction.
b. Obstruction or binding. 4. Check Tube Bottom Calibration.
c. Probe encoder (EN420) or connection.
629743AE
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
Probe clean valve is not E_34507 1. The probe clean VACUUM valve (VL341) status 1. Call BCI customer service. None.
operating properly. D340511 could not be confirmed.
D340701
D340741
D341010
D341141
D341507
D341514
D342501
D342518
D343004
D343012
Probe cleaning pump E_34022 1. Probe cleaning pump (PM102) did not rotate Perform the Dispense Diluent procedure. System Event: W, RBC,
delivery could not be D340513 properly. H, P, N, D, R Unless
verified. D341015 detail message says no
D341146 data affected. During
D341519 delivery of sample:
D342503 System Event: W, RBC,
D342523 H, P, N, D, R For probe
D343014 wash: System Event: R
Probe cleaning pump E_34021 1. Probe cleaning pump did not sense home due Perform the Clean Probe procedure. System Event: W, RBC,
did not sense home. D340512 to: H, P, N, D, R Depends
D340742 a. Probe cleaning pump (PM102) did not rotate on when the event
D341014 properly. occurs.
D341145 b. Probe cleaning HOME sensor (SN102) or
D341518 connection.
D342502
D342522

Event Messages from the SPM


D343013

Troubleshooting
10-59

10
Table 10.3 Info Event Messages (Continued)
10-60

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Probe vertical drive did E_34201 1. Probe did not sense home due to: Perform the Initialize SAM procedure. System Event: W, RBC,
not sense home. D340505 a. Obstruction or binding. H, P, N, D, R Depends
D340514 b. Probe HOME sensor (SN420) or connection. on when the event
D340522 occurs.
D340562
D340582
D340621
D340703
D340744
D341011
D341018
D341029
D341142
D341201
D341502
D341509
D341515
D342504
D342509
D342519
D343006
D343015
D343044
Probe vertical drive E_34203 1. Probe did not move properly due to: 1. Perform Extend/Retract Probe procedure. System Event: W, RBC,
move could not be D340516 a. Probe motor (MT420) or connection. 2. Remove cover and check for obstruction. H, P, N, D, R Depends
verified. D340584 b. Obstruction or binding. on when the event
D340705 occurs.
c. Probe encoder (EN420) or connection.
D341001
D341006
D341041
D341081
D341144
D341203
D341512
D341561
D342514
629743AE

D342516
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
Probe vertical drive E_34202 1. Probe did not sense home but recovered due to: Perform the Initialize SAM procedure. None.
sensed home after D340506 a. Obstruction or binding.
successful recovery. D340515 b. Probe HOME sensor (SN420) or connection.
D340523
D340704
D341012
D341019
D341030
D341143
D341202
D341503
D341510
D341516
D342505
D342510
D342520
D343007
D343016
Probe waste chamber E_34503 1. Vacuum momentarily is approaching the 1. Perform the Check Vacuum procedure. None.
vacuum error D340517 operating range due to:
recovered. D340706 a. Leaks or restrictions in the vacuum
D341026 pneumatic pathway.
D341147 b. Probe clean VACUUM valve (VL341) or probe
D341522 waste vac/PRES valve (VL343) malfunction
D341524
c. Pneumatic Supply module raw vacuum out
D341527
of specification.
D342526
D342528 d. Probe waste vacuum sensor (AD341) or
D343018 connection

Event Messages from the SPM


D343020

Troubleshooting
10-61

10
Table 10.3 Info Event Messages (Continued)
10-62

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Probe waste chamber E_34502 1. Vacuum exceeded the operating range due to: 1. Perform the Check Vacuum procedure. None.
vacuum exceeded the D340518 a. Leaks or restrictions in the vacuum 2. Check Pneumatic Supply module.
operating limits. D340707 pneumatic pathway. 3. Adjust the pressure and vacuum to proper value.
D340748 b. Probe clean VACUUM valve VL341 or probe
D341027 waste vac/PRES valve VL343 malfunction.
D341148
c. Pneumatic Supply module raw vacuum out
D341523
of specification.
D341525
D341528 d. Probe waste vacuum sensor (AD341) or
D342527 connection.
D342529
D343019
D343021
Probe waste drain did E_34505 1. The probe waste chamber (VC340) drain was 1. Perform the Drain Probe Waste procedure. None.
not sense empty. D341033 incomplete due to: 2. Check probe waste fluid DETECT sensor (SN340)
D343009 a. Pinched tubing and cable.
D343101 b. ENABLE probe waste drain valve (VL342)
fails to open,
c. Probe waste vac/PRES valve (VL343) fails to
switch from raw vacuum to raw pressure.
d. Probe waste fluid DETECT sensor (SN340) or
connection.
RBC or WBC ZAP E_31903 1. RBC ZAP voltage exceeded operating limits due 1. Perform the ZAP Apertures procedure. Repeat as None.
voltage exceeded the D312741 to required.
operating limits. D312761 a. Faulty CBC Transducer I/F board 2. Monitor RBC or WBC ZAP aperture voltages on
b. Faulty connection at CBC Transducer I/F the System Monitor screen using the Volt/Temp
board or bath. tab.
c. Suspect RBC ZAP voltage sensor (AD196) or 3. Perform Clean Aperture procedure if required.
connection.
2. WBC ZAP voltage exceeded operating limits due
to
a. Faulty CBC Transducer I/F board
b. Faulty connection at CBC Transducer I/F
board or bath.
629743AE

c. WBC ZAP voltage sensor (AD197) or


connection.
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
RBC or WBC ZAP E_31904 1. RBC ZAP voltage is approaching operating limits 1. Perform the ZAP Apertures procedure. Repeat as None.
voltage is approaching D312742 due to required.
the operating limits. D312762 a. Faulty CBC Transducer I/F board 2. Monitor RBC or WBC ZAP aperture voltages on
b. Faulty connection at CBC Transducer I/F the System Monitor screen using the Volt/Temp
board or bath. tab.
c. RBC ZAP voltage sensor (AD196) or 3. Perform Clean Aperture procedure if required.
connection.
2. WBC ZAP voltage is approaching operating
limits due to
a. Faulty CBC Transducer I/F board
b. Faulty connection at CBC Transducer I/F
board or bath.
c. WBC ZAP voltage sensor (AD197) or
connection.
RBC or WBC aperture E_31901 1. RBC or WBC aperture voltage exceeded 1. Call your Beckman Coulter Representative. None
voltage exceeded the D311661 operating limits due to
air limits. D311681 a. Air drawn through the aperture.
b. Incorrect high voltage
c. Faulty connection at CBC Transducer I/F
board or bath.
d. RBC (AD190, AD191, AD192) or WBC (
AD193, AD194, AD195) aperture voltage
sensor or connection.
RBC or WBC aperture E_31902 1. RBC or WBC aperture voltage is approaching 1. Perform the Zap Apertures procedure. Repeat as None.
voltage exceeded the D311662 operating limits due to required.
clog limits. D311682 a. Aperture clog or buildup. 2. Perform Clean Aperture procedure if required.

Event Messages from the SPM


b. Incorrect high voltage
c. Faulty connection at CBC Transducer I/F
board or bath.
d. RBC (AD190, AD191, AD192) or WBC (

Troubleshooting
AD193, AD194, AD195) aperture voltage
sensors or connections.
10-63

10
Table 10.3 Info Event Messages (Continued)
10-64

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
RBC or WBC reference E_31803 1. RBC or WBC Reference voltage exceeded 1. Call your Beckman Coulter Representative. System Event: W, RBC,
voltage exceeded the D311741 operating limits due to P
operating limits. a. CBC Transducer I/F board or connections.
b. RBC (AD185) or WBC (AD186) reference
voltage sensor or connection.
RBC or WBC reference E_31804 1. RBC or WBC Reference voltage is approaching 1. Call your Beckman Coulter Representative. None.
voltage is approaching D311742 operating limits due to
the operating limits. a. CBC Transducer I/F board or connections.
b. RBC (AD185) or WBC (AD186) reference
voltage sensor or connection.
RBC pump delivery E_31042 1. RBC pump (PM104) did not rotate properly. 1. Perform the Rinse Bath procedure. For RBC diluent
could not be verified. D312008 2. Perform the Deliver blank to Hgb procedure. delivery: None For Hgb
D312502 blank diluent delivery:
System Event: RBC, P,
H
RBC pump did not E_31041 1. RBC pump did not verify that it was home due 1. Perform the Rinse Bath procedure. For RBC diluent
sense home. D312007 to: 2. Perform the Deliver blank to Hgb procedure. delivery: None. For Hgb
D312501 a. RBC pump (PM104) did not rotate properly. blank diluent delivery:
b. RBC HOME sensor (SN104) or connection. System Event: RBC, P,
H
Reagent Services E_33201 1. Unable to determine reagent system status due 1. Power off and on to restart the SPM. None.
hardware failure. D330503 to a level sensor malfunction caused by a faulty
D330504 connection. (SN327,SN330, SN321, SN322,
D330505 SN323, SN324, SN325, SN326, SN350.)
D331102
D331202
D331302
D331402
D331502
D331602
Retic clear pump E_32022 1. Retic clear pump (PM202) did not rotate From the Diagnostic Procedures menu, select System Event: R
delivery could not be D322015 properly. Common Services > Fluidic > Prime Retic Clear.
verified.
629743AE
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
Retic clear pump did E_32021 1. Retic Lyse pump did not sense home due to: From the Diagnostic Procedures menu, select System Event: R
not sense home. D322014 a. Retic clear pump (PM202) did not rotate Common Services > Fluidic > Prime Retic Clear.
properly.
b. Retic clear HOME sensor (SN202) or
connection.
Retic stain pump E_32032 1. Retic stain pump (PM203) did not rotate From the Diagnostic Procedures menu, select System Event: R
delivery could not be D322010 properly. Common Services > Fluidic > Prime Retic Stain.
verified.
Retic stain pump did E_32031 1. Retic Stain pump did not sense home due to: From the Diagnostic Procedures menu, select System Event: R
not sense home. D322009 a. Retic stain pump (PM203) did not rotate Common Services > Fluidic > Prime Retic Stain.
properly.
b. Retic stain HOME sensor (SN203) or
connection.
SAM horizontal drive E_34401 1. SAM horizontal drive assembly did not sense 1. Remove the transport shield and look for an None.
assembly did not sense D340520 home due to: obstruction such as tube out of cassette.
home. D343041 a. Binding or obstruction of SAM horizontal 2. Replace the transport shield and perform the
drive assembly. Initialize SAM procedure.
b. SAM X-HOME sensor (SN440) or connection.
SAM horizontal drive E_34403 1. SAM horizontal drive assembly did not move 1. Remove the transport shield and look for an System Event: W, RBC,
assembly move could D340504 properly due to: obstruction such as tube out of cassette. H, P, N, D, R
not be verified. D340561 a. Binding or obstruction of SAM horizontal 2. Replace the transport shield and perform the
D340581 drive assembly. Initialize SAM procedure.
D341028 b. SAM X-encoder (EN440) or connection.
D341501
D342508
SAM horizontal drive E_34402 1. SAM horizontal drive assembly did not sense 1. Remove the transport shield and look for an None.

Event Messages from the SPM


assembly sensed home D340521 home but recovered due to: obstruction such as tube out of cassette.
after successful a. Binding or obstruction of SAM horizontal 2. Replace the transport shield and perform the
recovery. drive assembly. Initialize SAM procedure.
b. SAM X-HOME sensor (SN440) or connection.

Troubleshooting
10-65

10
Table 10.3 Info Event Messages (Continued)
10-66

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Sample or sheath E_32801 1. Sample and or sheath pressure exceeded 1. Go to the Diagnostic Procedures screen. System Event: N, D, R
pressure exceeded the D321561 operating limits due to: 2. Check Pneumatic Supply module. Depends on the test
operating limits. D321581 a. Sample pressure regulator (RG270), Sheath 3. Adjust pressure and vacuum to proper value. mode.
pressure regulator (RG280), leak, or raw
pressure problem.
b. Sample tank pres/VAC valve (VL270), or
sheath tank pres/VAC valve (VL280) not
sealing properly.
c. Sample pressure sensor (AD270), sheath
pressure sensor (AD280) or connection.
Sample or sheath E_32802 1. Sample and or sheath pressure is approaching Go to Diagnostic procedures > Maintenance tab. None.
pressure is D321562 operating limits due to:
approaching the D321582 a. Sample pressure regulator (RG270), Sheath
operating limits. pressure regulator (RG280), leak, or raw
pressure problem.
b. Sample tank pres/VAC valve (VL270), or
sheath tank pres/VAC valve (VL280) not
sealing properly.
c. Sample pressure sensor (AD270), sheath
pressure sensor (AD280) or connection.
Sheath or sample tank E_32701 1. Sample and or Sheath Tank did not fill due to: 1. Check diluent supply. System Event: N, D, R
did not indicate full D320501 a. Diluent depleted. 2. Perform Diagnostic procedure. Depends on the test
condition. D320502 b. Vacuum out of specification due to leak. mode.
Verify sheath/sample tank.
D320503
c. Sample tank FULL sensor (SN270), sheath 1. Verify sheath/sample tank.
tank FULL sensor (SN280) or connection.
Single tube station E_35502 1. Single tube station did not sense home but None. None.
recovered while D351102 recovered due to:
extending or D351103 a. Misalignment of single tube station lead
retracting. screw.
b. Obstruction of single tube station
movement by cover or cable routing.
c. MS HOME sensor (SN550) or electrical
connection.
629743AE

d. MS presentation motor (MT550) or electrical


connection.
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
Stripper vertical drive E_34301 1. Stripper did not verify it was home due to: Perform the Initialize SAM procedure. None.
did not sense home. D340508 a. Obstruction or binding.
D340524 b. Stripper HOME sensor (SN430) or
D340565 connection.
D340585
D341021
D341024
D341031
D341204
D341206
D341505
D342512
Stripper vertical drive E_34302 1. Stripper did not sense home but recovered due Perform the Initialize SAM procedure. None.
sensed home after D340509 to:
successful recovery. D340525 a. Obstruction or binding.
D340566 b. Stripper HOME sensor (SN430) or
D341025 connection.
D341032
D341205
D341506
D342513
Tube was detected E_34312 1. No tube sensed but recovered due to: Perform the Simulate Complete SAM Cycle None.
after a successful D341004 a. Tube DETECT sensor (SN431) or connection. procedure.
recovery. D341008 b. Wash collar malfunction.
D341062
D341083
Tube was detected E_34311 1. Tube was not properly sensed due to: Perform the Simulate Complete SAM Cycle None.
earlier than expected. D341003 a. Tube DETECT sensor (SN431) or connection. procedure.

Event Messages from the SPM


D341007 b. Wash collar malfunction.
D341061
D341082
Tube was not detected. E_34313 1. No tube present. Perform the Simulate Complete SAM Cycle None.

Troubleshooting
D341005 2. No tube sensed due to: procedure.
D341063 a. Tube DETECT sensor (SN431) or connection.
b. Wash collar malfunction.
10-67

10
Table 10.3 Info Event Messages (Continued)
10-68

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
Two or more CBC E_31905 1. RBC or WBC aperture voltage exceeded 1. Perform the Zap Apertures procedure. Repeat as For RBC aperture:
apertures had one or D313541 operating limits due to required. System Event: RBC, P
more parameters that a. Aperture clog or buildup. 2. Perform Clean Aperture procedure if required. For WBC aperture:
exceeded the b. Air drawn through the aperture. System Event: W
operating limits.
c. Incorrect high voltage
d. Faulty connection at CBC Transducer I/F
board or bath.
e. RBC (AD190, AD191, AD192) or WBC (
AD193, AD194, AD195) aperture voltage
sensors or connections.
Unable to read waste E_33421 1. Unable to determine waste level status due to 1. Check identified container for suspect level None.
status. D331702 Waste 1 FULL sensor (SN344), Waste 2 FULL sense connection.
D331704 sensor (SN345) or connection. 2. Replace float sensor.
D331706
D331707
D331708
D331709
Unexpected cassette E_35412 1. Cassette incorrectly sensed in pending Buffer. None. None.
at pending buffer D355202 a. Cassette left at pending buffer.
moved to the output b. STM pending sensor (SN541) or electrical
buffer. connection.
VCS diluent pump E_32062 1. VCS diluent pump (PM206) did not rotate From the Diagnostic Procedures menu, select VCSn System Event: N, D, R
delivery could not be D320717 properly. > Fluidic > Prime VCSn module. Depends on the test
verified. D322002 mode.
D322012
D322305
D322307
D323212
D324208
629743AE
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
VCS diluent pump did E_32061 1. VCS diluent pump did not sense home due to: From the Diagnostic Procedures menu, select VCSn System Event: N, D, R
not sense home. D320716 a. VCS diluent pump (PM206) did not rotate > Fluidic > Prime VCSn module. Depends on the test
D322001 properly. mode.
D322011 b. VCS diluent HOME sensor (SN206) or
D322304 connection.
D322306
D323211
D324207
VCS temperature E_32401 1. Block temperature exceeded operating limits 1. Check lab's environmental control system. For Block Reaction
exceeded the D321341 due to: 2. Check system fans for operation. temperature System
operating limits. D321351 a. VCSn block peltier (PL240), peltier fans, Event: N, D, R Depends
D321361 system fans, or connection. on the test mode. For
D321371 b. Block temperature sensor (AD240) or Stain Temperature
connection. System Event: R For
Mtm Plate Temperature
2. Stain chamber temperature exceeded operating System Event: N, D, R
limits due to: Depends on the test
a. Stain heater, system fans, or connection. mode. For Sample Line
b. Stain temperature sensor (AD260) or Temperature System
connection. Event: N, D, R Depends
on the test mode.
3. Mtm Plate temperature exceeded operating
limits due to:
a. MTM peltier (PL271), peltier fans, system
fans, or connection.
b. Mtm Plate temperature sensor (AD271) or
connection.
4. Sample line temperature exceeded operating
limits due to:

Event Messages from the SPM


a. Sample line peltier (PL275), peltier fans,
system fans, or connection.
b. Sample line temperature sensor (AD275) or

Troubleshooting
connection.
10-69

10
Table 10.3 Info Event Messages (Continued)
10-70

Event Messages from the SPM


Troubleshooting
Description Event Probable Cause Action Results Affected
Numbers
VCS temperature is E_32402 1. Block temperature is approaching operating Check lab's environmental control system. None.
approaching the D321342 limits due to:
operating limits. D321352 a. VCSn block peltier (PL240), peltier fans,
D321362 system fans, or connection.
D321372 b. Block temperature sensor (AD240) or
connection.
2. Stain chamber temperature is approaching
operating limits due to:
a. Stain heater, system fans, or connection.
b. Stain temperature sensor (AD260) or
connection.
3. Mtm Plate temperature is approaching
operating limits due to:
a. MTM peltier (PL271), peltier fans, system
fans, or connection.
b. Mtm Plate temperature sensor (AD271) or
connection.
4. Sample line temperature is approaching
operating limits due to:
a. Sample line peltier (PL275), peltier fans,
system fans, or connection.
b. Sample line temperature sensor (AD275) or
connection.
VCS waste chamber E_32221 1. VCSn waste chamber (VC222) did not drain due From the Diagnostic Procedures menu select System Event: N, D, R
drain did not sense D322013 to Maintenance > Check Pneumatic Supply.
empty. a. VCS vac/PRES valve (VL222) not sealing due
to a buildup on the diaphragm.
b. Restriction (buildup, clot) in the output
tubing or internal to the ENABLE VCS waste
valve (VL223).
c. A system pressure issue related to the VCS
waste chamber (VC222).
d. VCS waste fluid DETECT sensor (SN222) or
629743AE

connection.
Table 10.3 Info Event Messages (Continued)
629743AE

Description Event Probable Cause Action Results Affected


Numbers
VCSn Acquisition Time E_32103 1. Undetectable flow cell clog N/A None.
was longer than D321010 2. SCA unable to stop the acquisition properly.
expected.
Vacuum chamber E_33503 1. Liquid is detected in the vacuum chamber 1. Inspect the vacuum trap at the Pneumatic System Event: W, RBC,
detected liquid. D336003 (VC350) due to. Supply module. H, P, N, D, R
a. Overflow from other modules such as 2. Power off and power on to restart the SPM.
Reagent Services, VCS waste chamber 3. If problem continues, call your Beckman Coulter
(VCS222), RBC count chamber (VC105), Representative.
WBC count chamber (VC106), CBC waste
chamber (VC115), probe waste chamber
(VC340), sample tank (VC270), or sheath
tank (VC280) into the vacuum chamber
(VC350).
b. Vacuum chamber fluid DETECT sensor
(SN350L) or connection.
WBC pump delivery E_31032 1. WBC pump (PM103) did not rotate properly. Perform the Rinse Bath procedure. System Event: W, H
could not be verified. D312504
WBC pump did not E_31031 1. WBC pump did not verify that it was home due Perform the Rinse Bath procedure. System Event: W, H
sense home. D312503 to:
a. WBC pump (PM103) did not rotate properly.
b. WBC HOME sensor (SN103) or connection.

Event Messages from the SPM


Troubleshooting
10-71

10
Event Messages from the System Manager
10-72

Event Messages from the System Manager


Troubleshooting
The Error Messages from the System Manager are divided into two sections:

• Event Messages from the System Manager with Action Required


• Event Messages from the System Manager that Require No Action

Event Messages from the System Manager with Action Required


Error Messages, Warning Messages and Informational Messages are listed in the following tables. The Error Messages trigger an audible and visual
alarm. The Warning Messages trigger a yellow visual alarm. The Informational Messages do not trigger an audible or visual alarm. The tables in
this section are: Table 10.4, Error Event Messages, Table 10.5, Warning Event Messages, and Table 10.6, Info Event Messages.

In the tables that follow, the string “%#” (for example, %1:SPM) indicates an actual value generated by the error handling process within the
system. The value depends on the specific event that occurred.

Table 10.4 Error Event Messages

Description Detailed Description Probable Cause Customer Troubleshooting

A NULL or empty XML string was None. 1. Internal software error. 1. Call your Beckman Coulter
received for parsing. Representative.
A control has failed. Auto Stop triggered. The following control failed with %1: SPM: %2 1. Defective or expired control. 1. If a control is expired, replace the
Lot number: %3 Type: %4 Level: %5. 2. SPM is not operating correctly. control.
2. If a control is out, follow instructions
in HELP ('What to do when a control
is outside its expected ranges').
A matching patient specimen was found. An active patient specimen exists in the 1. Specimen had an existing order in a 1. Check Worklist for duplicate IDs.
Studies mode is enabled. Worklist for specimen %1 and the system is Worklist while in Studies mode.
configured for studies.
Specimen processing was skipped.
A/D resource busy. ActivityID %1, CommandID %2, 1. Software timing error. 1. Power off and power on SPM
ResourceID %3: A/D resource was already in
use when sample conversion was required.
A/D resource insufficient pairs. ActivityID %1, CommandID %2, 1. Software timing error. 1. Power off and power on SPM
629743AE

ResourceID %3: A/D resource was unable to


acquire the required number of pairs.
Table 10.4 Error Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Customer Troubleshooting

A/D resource not monitoring. ActivityID %1, CommandID %2, 1. Software timing error. 1. Power off and power on SPM
ResourceID %3: A/D resource was not in
monitoring mode.
A/D resource not ready. ActivityID %1, CommandID %2, 1. Software timing error. 1. Power off and power on SPM
ResourceID %3: A/D resource was not ready
when required.
A/D resource timeout. ActivityID %1, CommandID %2, 1. Software timing error. 1. Power off and power on SPM
ResourceID %3: timeout occurred waiting for
A/D resource value.
An XML parsing error occurred. An XML parsing error occurred: %1. 1. Internal software error. 1. Call your Beckman Coulter
Representative.
An XML parsing error occurred: empty The parser expected attributes for this object 1. Internal software error. 1. Call your Beckman Coulter
attribute set for object. (%1) and none were provided. Representative.
An XML parsing error occurred: invalid The attribute value received for this object 1. Internal software error. 1. Call your Beckman Coulter
attribute value. was not valid: Object name: %1 Attribute Representative.
name: %2 Attribute value: %3.
An invalid collation ID was received from An invalid collation ID was received from the 1. Internal software error. 1. Call your Beckman Coulter
the System Manager. System Manager. Representative.
Collation ID: %1.
An invalid object type was parsed. Type expected: %1 Type parsed: %2. 1. Internal software error. 1. Call your Beckman Coulter
Representative.
An invalid primary ID was received. A invalid specimen primary ID was received. 1. Internal software error. 1. Call your Beckman Coulter

Event Messages from the System Manager


The specimen could not be processed. Representative.

Primary ID value: %1 Primary ID type: %2.


An invalid secondary ID was received. An invalid secondary ID value was received 1. Internal software error. 1. Call your Beckman Coulter
for a uniquely-identified specimen. Representative.
The specimen could not be processed.
Secondary ID value: %1 Secondary ID

Troubleshooting
type: %2.
Attempt to acknowledge results receipt Attempt to send results receipt 1. Internal software error. 1. Call your Beckman Coulter
failed. acknowledgement to the System Manager Representative.
failed for result ID %1.
10-73

Error code: %2.

10
Table 10.4 Error Event Messages (Continued)
10-74

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Customer Troubleshooting

Attempt to perform auto stop failed. Attempt to auto stop SPM %1 failed. 1. Installation problem. 1. Call your Beckman Coulter
Error code: %2. Representative.

Attempt to retrieve SPM configuration Attempt to retrieve list of SPM configurations 1. Internal software error. 1. Call your Beckman Coulter
failed. from the System Manager failed. 2. Installation problem. Representative.
Error code: %1.
Attempt to retrieve audible alarm setting Attempt to retrieve audible alarm setting 1. Internal software error. 1. Call your Beckman Coulter
failed. from the System Manager failed. Representative.
Error code: %1.
Auto Stop triggered, an SPM has been SPM: %1. 1. Specimen related problem. 1. Follow HELP instructions for the
taken offline. 2. SPM calibration problem. specific occurrence.
3. SPM performance problem.
Auto Stop triggered, an SPM has been SPM: %1. 1. Specimen related problem. 1. Follow HELP instructions for the
taken offline. 2. SPM calibration problem. specific occurrence.
3. SPM performance problem.
Barcode Reader setting up failed Failed to configure barcode reader. 1. Internal software error. 1. Call your Beckman Coulter
Representative.
CAN bus impedance not terminated For this MRC the CAN-OUT port is not OPEN. 1. The CAN communication ribbon 1. Power off and power on SPM
properly for %1 MRC (Host ID: %2) cable is improperly connected
CAN bus impedance not terminated The MRC cannot verify the integrity of CAN 1. The CAN communication ribbon 1. Power off and power on SPM
properly for %1 MRC (Host ID: %2). connection. cable is improperly connected to this
MRC.
CBC MRC (Host ID: 10) not responding Command sent to CBC MRC board was not One of the following components is 1. Power off and power on SPM
acknowledged. disconnected or has experienced a fault:
This can occur during power up or hardware 1. CAN cable
configuration retrieval. 2. Module ID board
3. COMM I/F card
4. CBC MRC board
5. MRC software application corrupted.
CLR framework error. Call your Beckman CLR framework error. 1. Internal software error. 1. Call your Beckman Coulter
Coulter Representative. Call your Beckman Coulter Representative. Representative.
629743AE

Type: %1 Message: %2 Source: %3.


Table 10.4 Error Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Customer Troubleshooting

Cannot find system path in the system System registry does not contain a valid 1. Installation problem. 1. Call your Beckman Coulter
registry. entry for the system path. Representative.
Cannot load language library for module. Language:%1 Module:%2. 1. Installation problem. 1. Call your Beckman Coulter
Representative.
Communication timeout with SPM Communication between SPM Module ID/ 1. SPI cable loose or disconnected 1. Power off and power on SPM
Module ID/Audio board. Audio board and PI CPU card has timed out.
This can occur during power up or hardware
configuration retrieval.
Correct XML parser not installed. The correct version of the XML parser is not 1. Internal software error. 1. Call your Beckman Coulter
installed. Representative.
Could not determine unique specimen Could not determine a unique specimen 1. Internal software error. 1. Call your Beckman Coulter
order. order for result ID %1. Representative.
Multiple orders are related to the same result
ID.
Could not read specimen ID or cassette Could not read specimen bar code or 1. Invalid bar-code label. 1. Verify the bar-code label.
bar codes. cassette bar code. 2. Perform the Bar-code Reader
SPM: %1. Alignment procedure.
3. Perform Bar-code Read Rate test.
Could not read specimen bar code. SPM: %1. 1. Invalid bar-code label. 1. Verify the bar-code label.
2. Verification read failed. 2. Perform Bar-code Reader Alignment
procedure.
3. Perform Bar-code Read Rate test.

Event Messages from the System Manager


Could not start maintenance procedure. Could not place SPM OFFLINE. 1. SPM is busy. 1. Wait until current SPM operation is
complete and then repeat request.
2. Power off and power on SPM.
Daily Checks procedure incomplete. The procedure started and detected an error. 1. Waste container full. 1. Check event log for cause of failure.
2. Diluent depleted. 2. Correct the problem.
3. Run Daily Checks procedure
manually.

Troubleshooting
Daily Checks procedure incomplete. The procedure is in an invalid state. None 1. Run Daily Checks manually.
10-75

10
Table 10.4 Error Event Messages (Continued)
10-76

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Customer Troubleshooting

Data stored on SPM Module ID/Audio Data stored on SPM Module ID/Audio board 1. Data on SPM Module ID/Audio board 1. Power off and power on SPM
board EEPROM is corrupt. EEPROM is corrupt (CRC is invalid). is corrupted
This can occur during power up or hardware
configuration retrieval.
Database error. A database error (code=%1) 1. Internal software error. 1. Call your Beckman Coulter
occurred: %2 %3. Representative.
Database item validation error. A validation error occurred while validating 1. Internal software error. 1. Call your Beckman Coulter
a %1 database item. Representative.
Error text = %2.
Database query error. A database query error (code=%1) occurred: 1. Internal software error. 1. Call your Beckman Coulter
QUERY STRING=%2 %3. Representative.
Default order contained an invalid test. The default order for specimen %1 contained 1. Internal software error. 1. Call your Beckman Coulter
an invalid test. Representative.
The specimen could not be processed.
Invalid test: %2.
Disconnected expansion board for %1 This MRC has detected expansion port: %3 1. SPI cable loose or disconnected. 1. Power off and power on SPM
MRC (Host ID: %2). disconnected from the %4 board.
Duplicate specimen ID. Specimen processing was skipped for %1 at 1. Specimen already loaded. Do not run duplicate patient samples
SPM %2. specimen on transport simultaneously.
The specimen was already loaded.
Empty parameter definitions received. Empty parameter definitions list received 1. Installation problem. 1. Call your Beckman Coulter
from the System Manager. Representative.
Empty test panel definitions received. Retrieved empty test panel definition list 1. Installation problem. 1. Call your Beckman Coulter
from the System Manager. Representative.
Error creating window. An error occurred creating the %1 window. 1. Internal software error. 1. Call your Beckman Coulter
Make sure all ActiveX controls are properly Representative.
registered.
Error formatting test values. Error formatting test values: %1. 1. Internal software error. 1. Call your Beckman Coulter
Representative.
629743AE
Table 10.4 Error Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Customer Troubleshooting

Error initializing database. An error occurred initializing the %4 1. Internal software error. 1. Call your Beckman Coulter
database. Representative.
Reported error: %1 Server name = %2
Physical server = %3 Logical Db name = %4
Physical Db name = %5 Logical Dict name
= %6 Physical Dict name = %7.
Error loading language text. Error loading %1 language text library. 1. Installation problem. 1. Call your Beckman Coulter
Representative.
Event descriptor not found. Event descriptor: %1 Parameters: %2. 1. Installation problem. 1. Call your Beckman Coulter
Representative.
Exception during results processing. Processing for results received from System 1. Internal software error. 1. Call your Beckman Coulter
Manager failed because an exception Representative.
occurred.
Expansion ports communication error for A diagnostic fault was detected on this board 1. MRC experienced a fault. 1. Power off and power on SPM
%1 MRC (Host ID: %2) during the SPI decoding portion of the power
up communication test.
Expected database object not found. Expected object (type=%1) not found. 1. Internal software error. 1. Call your Beckman Coulter
ObjectId = (%2:%3) BlockId=%4. Representative.

Failed reading Events Expiration Rules Failed reading Events Expiration Rules XML 1. Installation problem. 1. Call your Beckman Coulter
XML file. file: %1. Representative.
Failed to add test. Panel requested could not be added to test 1. Test was already in progress. 1. Call your Beckman Coulter
order. 2. Wrong panel for the specimen type. Representative.

Event Messages from the System Manager


Panel name: %1 Reason: %2. 3. Unsupported panel.
4. Panel disabled.
5. Exceeded maximum number of runs
for specimen.
6. Internal system error.
Failed to add/remove a panel. Exception An attempt to add or remove a test panel 1. Internal system error. 1. Call your Beckman Coulter
occurred. failed because of an unknown error or Representative.

Troubleshooting
exception.
Specimen ID: %1 Tube position ID: %2 Panel
name: %3.
10-77

10
Table 10.4 Error Event Messages (Continued)
10-78

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Customer Troubleshooting

Failed to add/remove panel. Mismatched An attempt to add or remove a test panel 1. Wrong panel for the specimen type. 1. Call your Beckman Coulter
fluid types. failed because the panel fluid type does not Representative.
match the fluid type of the specimen.
Specimen ID: %1 Tube position ID: %2 Panel
name: %3.
Failed to add/remove panel. Panel not An attempt to add or remove a test panel 1. Test panel not enabled. 1. Call your Beckman Coulter
available. failed because the panel type was not Representative.
enabled.
Specimen ID: %1 Tube position ID: %2 Panel
name: %3.
Failed to add/remove panel. The panel An attempt to add or remove a test panel 1. Test panel in progress. 1. Call your Beckman Coulter
was already in progress. failed because the panel was in progress. Representative.
Specimen ID: %1 Tube position ID: %2 Panel
name: %3.
Failed to add/remove panel. An attempt to add or remove a test panel 1. Unsupported panel. 1. Call your Beckman Coulter
Unsupported or unknown panel type. failed because the panel type is unknown or Representative.
unsupported.
Specimen ID: %1 Tube position ID: %2 Panel
name: %3.
Failed to complete result calculations. The results algorithm failed attempting to 1. Installation problem. 1. Call your Beckman Coulter
compute additional results for specimen %1. Representative.
Mode: %2 Operation: %3 HRESULT: %4
Error: %5.
Failed to connect to System Manager. System Manager class %1 not registered. 1. Installation problem. 1. Call your Beckman Coulter
Error code: %2. Representative.

Failed to connect to System Manager. Failed to create System Manager instance for 1. Installation problem. 1. Call your Beckman Coulter
class %1, with interface %2. Representative.
Error code: %3.
Failed to connect to System Manager. Failed to create global interface table entry 1. Installation problem. 1. Call your Beckman Coulter
for interface %1. Representative.
Error code: %2.
629743AE
Table 10.4 Error Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Customer Troubleshooting

Failed to connect to System Manager. Failed to retrieve interface %1 for the System 1. Installation problem. 1. Call your Beckman Coulter
Manager. Representative.
Error code: %2.
Failed to parse Worklist filter XML file. Failed to validate XML file while parsing 1. Installation problem. 1. Call your Beckman Coulter
WorklistCannedFilter.xml in the read-only Representative.
directory for updating Worklist filters.
Failed to read IQAP definition file. The attempt to read the IQAP unit set 1. Installation problem. 1. Call your Beckman Coulter
definition file failed. Representative.
Error: %1.
Failed to read from the recovery None. 1. Internal software error. 1. Call your Beckman Coulter
configuration. Representative.
Failed to read whole blood limit. Error: %1. 1. Internal software error. 1. Call your Beckman Coulter
Representative.
Failed to remove a panel. Panel was not An attempt to remove a test panel failed 1. Test panel not requested as a part of 1. Call your Beckman Coulter
requested in the order. because the panel type was not requested as the order. Representative.
part of the order.
Specimen ID: %1 Tube position ID: %2 Panel
name: %3.
Failed to restore configuration Failed to restore configuration information to 1. Internal software error. 1. Call your Beckman Coulter
information. the System Manager. Representative.
Error code: %1.
Failed to retrieve bar-code configuration. Failed to retrieve bar-code configuration from 1. Internal software error. 1. Call your Beckman Coulter

Event Messages from the System Manager


the System Manager. Representative.
Error code: %1.
Failed to retrieve batch mode. Failed to retrieve batch mode from the 1. Internal software error. 1. Call your Beckman Coulter
System Manager. Representative.
Error code: %1.
Failed to retrieve configuration Failed to retrieve configuration information 1. Internal software error. 1. Call your Beckman Coulter

Troubleshooting
information. from the System Manager. Representative.
Error code: %1.
10-79

10
Table 10.4 Error Event Messages (Continued)
10-80

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Customer Troubleshooting

Failed to retrieve enabled parameters. Failed to retrieve enabled and acknowledged 1. Internal software error. 1. Call your Beckman Coulter
parameters from the System Manager. Representative.
Error code: %1.
Failed to retrieve parameter definitions. Failed to retrieve parameter definitions from 1. Internal software error. 1. Call your Beckman Coulter
the System Manager. 2. Installation problem. Representative.
Error code: %1.
Failed to retrieve report information. Failed to retrieve report information from the 1. Installation problem. 1. Call your Beckman Coulter
System Manager. Representative.
Error code: %1.
Failed to retrieve test panel definitions. Failed to retrieve test panel definitions from 1. Internal software error. 1. Call your Beckman Coulter
the System Manager. 2. Installation problem. Representative.
Error code: %1.
Failed to save database information. Failed to save database information for the 1. Backup was interrupted 1. Retry backup
System Manager.
Error code: %1.
File exception error. Filename:%1, error message:%2. 1. Internal software error. 1. Call your Beckman Coulter
Representative.
Group contains undefined parameter. The DM has defined a group %1 that uses an 1. Wrong panel for the specimen type. 1. Call your Beckman Coulter
undefined parameter %2. Representative.
Host error: serial port properties not Error in applying serial port properties. 1. Internal software error. 1. Call your Beckman Coulter
applied. Representative.
Host error: transmission to LIS failed. Result transmission to LIS failed; the result is 1. Host interface down. 1. Verify the connections on the System
queued. 2. Loose cable connection. Manager.
2. Contact the LIS vendor.
Incompatible specimen type for label The default order for specimen %1 contained 1. Internal software error. 1. Call your Beckman Coulter
order. a specimen type that could not be used with Representative.
one of the tests in the label order.
The specimen could not be processed.
Specimen type: %2 Test: %3.
629743AE
Table 10.4 Error Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Customer Troubleshooting

Incompatible specimen type in default The default order for specimen %1 contained 1. Internal software error. 1. Call your Beckman Coulter
order. a specimen type that could not be used with Representative.
one of the tests in the default order.
The specimen could not be processed.
Specimen type: %2 Test: %3.
Inconsistent database object. An object was found in the database that has 1. Internal software error. 1. Call your Beckman Coulter
inconsistent one to one relationship with Representative.
another database object.
Error code: %1 Object: %2 %3 Refers to an
object %4 OID: %5.
Inconsistent database object. An object was found in the database that has 1. Internal software error. 1. Call your Beckman Coulter
an inconsistent one to many relationship with Representative.
another database object.
Error code: %1 Object: %2 %3 Is not
contained within the set of %2 objects for
Object: %4 %5.
Incorrect number of specimens detected 1. Cassette loaded improperly. 1. Verify that the specimens presented
during Carryover procedure. for Carryover are placed in the
appropriate order in the cassette:
one blood specimen followed by
three diluent specimens.
Incorrect specimen type detected during Incorrect specimen type was detected when 1. Cassette loaded improperly. 1. Verify that the specimens presented
Carryover procedure. sample was aspirated. for Carryover are placed in the

Event Messages from the System Manager


appropriate order in the cassette:
one blood specimen followed by
three diluent specimens.
Invalid IQAP definitions read. The IQAP unit set definitions XML read from 1. Installation problem. 1. Call your Beckman Coulter
the IQAP definitions file was invalid. Representative.
Invalid bar-code format for specimen ID The number of characters read for the 1. Bar-code reader is not configured for 1. Check bar-code configuration.
label [I2of5] digits. specimen ID using I2of5 does not match the the right number of digits for the I2 of

Troubleshooting
configured number of digits. 5 symbology.
Tube position ID: %1 SPM name: %2.
10-81

10
Table 10.4 Error Event Messages (Continued)
10-82

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Customer Troubleshooting

Invalid collation ID. An invalid collation ID was used to retrieve 1. Internal software error. 1. Call your Beckman Coulter
analysis information. Representative.
Collation ID: %1.
Invalid event log message from System Invalid event log message: %1 Parsing 1. Installation problem. 1. Call your Beckman Coulter
Manager. error: %2. Representative.
Invalid flag received. Flag %1 cannot be added to specimen order. 1. Internal software error. 1. Call your Beckman Coulter
The flag name is invalid. Representative.

Invalid label found on a control A control specimen was loaded with an 1. Unknown control label.(Label 1. Inspect specimen label for invalid
specimen. invalid label: %1, The specimen could not be contains invalid characters or invalid characters or invalid format.
processed. format.) 2. Try another control.
Invalid parameter group definitions. The parameter group definitions read from 1. Installation problem. 1. Call your Beckman Coulter
the parameter group definition file was Representative.
invalid.
Invalid parameter received from System Invalid parameter %1 received from System 1. Installation problem. 1. Call your Beckman Coulter
Manager. Manager. Representative.
Invalid parameter result generated by The System Manager results algorithm 1. Installation problem. 1. Call your Beckman Coulter
the System Manager algorithm. generated a result for an invalid Representative.
parameter %1.
Call your Beckman Coulter Representative.
Invalid reuse of specimen ID. Multiple active test orders were received for 1. Specimen Id reuse 1. Check Worklist for duplicate IDs.
specimen %1 containing different patient
IDs.
The specimen could not be processed.
Invalid specimen type in default order. The default order for specimen %1 contained 1. Internal software error. 1. Call your Beckman Coulter
an invalid specimen type. Representative.
The specimen could not be processed.
Invalid specimen type: %2.
Invalid state reported for liquid detector ActivityID %1, CommandID %2, 1. Software timing error. 1. Power off and power on SPM
sensor. ResourceID %3: liquid detector has reported
a state unexpected by the embedded
software.
629743AE
Table 10.4 Error Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Customer Troubleshooting

Invalid vector result sent for parameter. Invalid vector result sent for parameter %1. 1. Installation problem. 1. Call your Beckman Coulter
Elements = %2, data size = %3, buffer size Representative.
= %4.
Label order contained an invalid test. The label order for specimen %1 contained 1. Internal software error. 1. Call your Beckman Coulter
an invalid test. Representative.
The specimen could not be processed.
Invalid test: %2.
Laboratory initialization: no operating None. 1. Installation problem. 1. Call your Beckman Coulter
limits defined. Representative.
Language prefix error. Language prefix (%1) must be three 1. Internal software error. 1. Call your Beckman Coulter
characters in length. Representative.
Load library failed. Library %1 of module %2 failed to load. 1. Installation problem. 1. Call your Beckman Coulter
Representative.
MFC exception occurred. Error message:%1. 1. Internal software error. 1. Call your Beckman Coulter
Representative.
Maximum number of No Match events Maximum number of consecutive No Match 1. Representation of specimens 1. Check the No Match Auto Stop
reached. events has been reached. previously processed. setting to ensure it has been
A No Match event occurs when no test order 2. LIS download was not successful configured correctly.
is identified for a specimen that has been 3. Bar code reader configuration 2. Check that the host orders are
presented. accepted by the instrument and
logged in the Worklist Pending list.
3. Check the bar code label on the

Event Messages from the System Manager


specimen tube to ensure it is not
damaged.
4. Check that the bar code label
information in the Worklist Pending
list matches the bar code on the
specimen as read by the instrument.
5. Check that the bar code reader is
reading the bar code labels on the

Troubleshooting
specimen tubes.
10-83

10
Table 10.4 Error Event Messages (Continued)
10-84

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Customer Troubleshooting

Maximum number of No Read events The maximum number of consecutive No 1. Bar code label configuration 1. Check the No Read Auto Stop setting
reached. Read events has been reached for a bar code 2. Bar code reader failure to ensure it has been configured
reader %1. 3. Orientation of specimens in cassette correctly.
A No Read event occurs when a bar code 2. Check the bar code label on the
reader fails to read the specimen ID. specimen tube to ensure it is not
damaged.
3. Check that the bar code reader is
reading the bar code labels on the
specimen tubes.
Maximum number of Partial Aspiration Maximum number of consecutive Partial 1. Plugged aspiration probe 1. Check the Partial Aspiration Auto
events reached. Aspiration events has been reached. Stop setting to ensure it has been
A Partial Aspiration event occurs when the configured correctly.
SPM is unable to aspirate sufficient sample to 2. Verify there is sufficient sample in
analyze the specimen. the tube.
3. Perform Dispense Diluent procedure
to verify the aspiration path is clear
and does not contain any blockages.
4. Run the Verify Blood Detector
diagnostic procedure.
Maximum number of Total Voteout Maximum number of consecutive Total 1. Insufficient CBC lyse reagent 1. Verify that the CBC Lyse reagent is
events reached. Voteout events for patient processing has 2. Plugged aperture being dispensed to the WBC bath.
been reached for test parameter %1. 2. Check the Voteout Auto Stop setting
to ensure it has been configured
correctly.
3. Perform the Zap Aperture diagnostic
procedure.
Maximum number of consecutive CBC Errors occurred on SPM %1. None 1. Check event log for cause of failure.
module errors reached. 2. Correct the problem.
Maximum number of consecutive CSM Errors occurred on SPM %1. None 1. Check event log for cause of failure.
errors reached. 2. Correct the problem.
Maximum number of consecutive Diff Errors occurred on SPM %1. None 1. Check event log for cause of failure.
errors reached. 2. Correct the problem.
Maximum number of consecutive NRBC Errors occurred on SPM %1. None 1. Check event log for cause of failure.
629743AE

errors reached. 2. Correct the problem.


Table 10.4 Error Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Customer Troubleshooting

Maximum number of consecutive Retic Errors occurred on SPM %1. None 1. Check event log for cause of failure.
errors reached. 2. Correct the problem.
Maximum number of consecutive SAM Errors occurred on SPM %1. None 1. Check event log for cause of failure.
errors reached. 2. Correct the problem.
Maximum number of consecutive Bar-code reader %1 read duplicate specimen 1. Mislabeled specimen. 1. Check specimen tubes for duplicate
duplicate specimen IDs reached. IDs. 2. Cassette was rerun before exiting. labels.

Maximum number of specimen A mismatch occurs when the secondary 1. Data entry error. 1. Correct secondary identifier in the
mismatches reached. identifier does not match the worklist. worklist.
Missing parameter group definition for No parameter group definition found for 1. Installation problem. 1. Call your Beckman Coulter
parameter. parameter %1. Representative.
Motor encoder reported missed steps. ActivityID %1, CommandID %2, 1. Obstruction. 1. Remove obstruction.
ResourceID %3. 2. Motor or encoder cable loose or
disconnected.
Motor move to sensor timeout. ActivityID %1, CommandID %2, 1. Obstruction. 1. Power off and power on SPM.
ResourceID %3: Timeout occurred while 2. Faulty sensor or motor interconnect.
looking for sensor.
Multiple conflicting result values Multiple results were produced for 1. Internal software error. 1. Call your Beckman Coulter
produced for a specimen. specimen %1 for the same parameter %2. Representative.
The results were rejected.
No pending tests found for specimen. The test order for specimen %1 contained no 1. No pending tests for specimen. Review Worklist for completed but not
pending tests to run. released specimens with matching
specimen ID.

Event Messages from the System Manager


No test order and no default order No test order was found for specimen %1, 1. No test order exists for the specimen 1. Download the test order from LIS
defined. and no default test order was defined for 2. Default order not configured 2. Manually order a test
SPM %2. 3. Configure a default order for the
The specimen could not be processed. entry point
No test order could be generated. The system could not generate a test order 1. Internal software error. 1. Call your Beckman Coulter
for specimen %1. Representative.

Troubleshooting
The specimen could not be processed.
10-85

10
Table 10.4 Error Event Messages (Continued)
10-86

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Customer Troubleshooting

No test order defined for batch Batch processing was requested for 1. Internal software error. 1. Call your Beckman Coulter
processing. specimen %1, but no default order was Representative.
defined for SPM %2.
The specimen could not be processed.
No test order found to process results. No valid test order found to process results 1. Internal software error. 1. Call your Beckman Coulter
for specimen %1, collation ID %2. Representative.
No values supplied for report job. The System Manager report job request 1. Internal software error. 1. Call your Beckman Coulter
contained no report values. Representative.
Title: %1 Name: %2.
OLE dispatch error. Error code:%1, error message:%2. 1. Internal software error. 1. Call your Beckman Coulter
Representative.
OLE error. Error code:%1, error message:%2. 1. Internal software error. 1. Call your Beckman Coulter
Representative.
Object meta type incorrect. XML file reports class type as %1, but 1. Internal software error. 1. Call your Beckman Coulter
database class type is %2. Representative.
Operating limit changed for test The database currently being updated 1. Internal software error. 1. Call your Beckman Coulter
parameter. contains an existing operating limit for test Representative.
parameter %1 which is less constraining than
the new operating limit.
Operating limits for test parameters may not
be changed during a database update
without creating a database inconsistency.
The current database must be discarded and
a new, empty database must be populated
with this new set of test parameters.
Panel contains undefined parameter. The System Manager has sent a panel %1 1. Internal software error. 1. Call your Beckman Coulter
that uses an undefined parameter %2. Representative.
629743AE
Table 10.4 Error Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Customer Troubleshooting

Parameter deleted. The database currently being updated 1. Internal software error. 1. Call your Beckman Coulter
contains one or more test parameters which Representative.
have been deleted or renamed: %1.
Test parameters may not be deleted or
renamed without creating a database
inconsistency.
The current database must be discarded and
a new, empty database must be populated
with this new set of test parameters.
Persistent object not found. The persistent object with object ID %1 could 1. Internal software error. 1. Call your Beckman Coulter
not be found in the database. Representative.
It may have been deleted or was never
stored.
RS MRC (Host ID: 30) not responding Command sent to RS MRC board was not One of the following components is 1. Power off and power on SPM
acknowledged. disconnected or has experienced a fault:
This can occur during power up or hardware 1. CAN cable
configuration retrieval. 2. Module ID board
3. COMM I/F card
4. PS MRC board
5. MRC software application corrupted.
Reagent is depleted. The SPM has detected that the %1 reagent 1. Reagent out 1. Check the reagent on the system
has been depleted. 2. Reagent supply pathway failure and replace the reagent if it is low or
empty.

Event Messages from the System Manager


2. Check the pick up line and ensure it
is properly connected.
Reagent should be depleted. The SPM has consumed more than the None 1. Replace reagent. Make sure new
maximum volume for %1 supply. reagent is set up on the Supplies
screen.
Reagents not available. Reagents for processing tests for 1. Reagents not available. 1. Check reagents.
specimen %1 were not available at SPM %2.

Troubleshooting
Tests rejected: %3.
Required parameter for generating Required parameter %2 for generating 1. Internal software error. 1. Call your Beckman Coulter
dataplots missing. dataplots %1 not found. Representative.
10-87

10
Table 10.4 Error Event Messages (Continued)
10-88

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Customer Troubleshooting

Rerun secondary ID did not match value A specimen was reloaded with a secondary 1. A rerun was requested for a 1. Place the tube back on the original
in test order. ID %2 that did not match the secondary ID specimen that had a pre-assigned carrier in the pre-assigned position
defined in the test order for %1. secondary Identifier and the 2. Do not pre-assign secondary
The specimen could not be processed. specimen was moved to another Identifiers if you want to move
cassette. specimens to other cassettes.
Resource concurrent use conflict. ActivityID %1, CommandID %2, 1. Defective diluter controller software. 1. Power off and power on instrument
ResourceID %3: The mutual exclusion lock
timed out.
Restart after unrecoverable exception. Restart of the embedded application 1. VME hardware issue. 1. Power off and power on SPM
occurred after unrecoverable exception
cause (%1), address (%2).
Restore attempt failed. Failed while attempting to restore 1. Internal software error. 1. Call your Beckman Coulter
configuration from failure recovery backup. Representative.
SAM MRC (Host ID: 40) not responding. Command sent to SAM MRC board was not One of the following components is 1. Power off and power on SPM
acknowledged. disconnected or has experienced a fault:
This can occur during power up or hardware 1. CAN cable
configuration retrieval. 2. Module ID board
3. COMM I/F card
4. SAM MRC board
5. MRC software application corrupted.
SAX COM error. COM error during SAX parsing of object %1 1. Internal software error. 1. Call your Beckman Coulter
Source: %2 Description: %3. Representative.
SEH (kernel) exception. The trans_func called with code:%1 from 1. Internal software error. 1. Call your Beckman Coulter
address:%2. Representative.
SPM alarm command failed. Transmission of an alarm command to the 1. Internal software error. 1. Call your Beckman Coulter
System Manager failed. Representative.
Command: %1 Error code: %2 SPM ID: %3
Alarm Type: %4.
SPM prime did not succeed. A prime occurs when transitioning from the 1. Out of reagents. 1. Check the reagents on the system
idle state to an operational state. and replace any reagents that might
be low or empty.
2. Check all pick up lines and ensure
629743AE

they are properly connected.


Table 10.4 Error Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Customer Troubleshooting

SPM serial number undefined The SPM serial number could not be retrieved 1. SPI cable disconnected 1. Power off and power on SPM
from the SPM Module ID/Audio board. 2. Data on SPM Module ID/Audio board
This can occur during power up or hardware is corrupted
configuration retrieval.
STM MRC (Host ID: 50) not responding. Command sent to STM MRC board was not One of the following components is 1. Power off and power on SPM
acknowledged. disconnected or has experienced a fault:
This can occur during power up or hardware 1. CAN cable
configuration retrieval. 2. Module ID board
3. COMM I/F card
4. STM MRC board
5. MRC software application corrupted.
Secondary ID did not match the value in A specimen was loaded with a secondary 1. A run was requested for a specimen 1. Place the specimen back in the
test order. identifier: %2, that did not match the that had a pre-assigned secondary specified cassette, in the pre-
secondary identifier defined in the test order identifier and the specimen was assigned position.
for primary identifier: %1. moved to another cassette. 2. Do not pre-assign secondary
The specimen could not be processed. identifiers if you want to move
specimens to other cassettes.
Shutdown procedure incomplete. The procedure is in an invalid state. None 1. Run prime.
2. Run Shutdown manually.
Specimen ID verification failed. The specimen ID read for specimen %1 failed 1. Invalid bar-code label. 1. Verify the bar-code label.
verification. 2. Verification read failed. 2. Perform Bar-code Reader Alignment
procedure.

Event Messages from the System Manager


3. Perform Bar-code Read Rate test.
Tests ordered could not be run. Tests ordered for specimen %1 could not be 1. Internal software error. 1. Call your Beckman Coulter
run. Representative.
SPM: %2 Tests rejected: %3.
The database object was not found. The object referenced (%1:%2) was not 1. Internal software error. 1. Call your Beckman Coulter
found in the database. Representative.
It was probably deleted prematurely.

Troubleshooting
The replacement of the consumable on A system error prevented the completion of None 1. Restart the procedure.
SPM %1 was interrupted. consumable replacement.
Timeout during processing of System Message identification: %1. 1. Internal software error. 1. Call your Beckman Coulter
10-89

Manager message. Representative.

10
Table 10.4 Error Event Messages (Continued)
10-90

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Customer Troubleshooting

Timeout waiting for shift information Timed out waiting to retrieve shift 1. Internal software error. 1. Call your Beckman Coulter
retrieval. information for the System Manager. Representative.
Timeout waiting for unit conversion. Unit conversion: %1. 1. Internal software error. 1. Call your Beckman Coulter
Representative.
Tube position ID no read Tube position ID was not read for 1. Bad or missing cassette bar-code 1. Verify the cassette bar-code label.
specimen %1 at SPM %2. label. 2. Perform Bar-code Reader Alignment
Specimen processing skipped. 2. Mis-aligned barcode reader. procedure.
3. Perform Bar-code Read Rate test.
Unable to communicate with bar-code MRC %1 could not communicate with bar- 1. Disconnected cable. 1. Power off and power on SPM
reader. code reader. 2. Bar-code reader fault.
Unable to install SAX handler during XML A SAX event handler failed to install during 1. Internal software error. 1. Call your Beckman Coulter
parsing. XML parsing for object %1. Representative.
Unexpected CDATA during XML parsing. During XML parsing for object %1, CDATA 1. Internal software error. 1. Call your Beckman Coulter
was received with no XML object Representative.
defined: %2.
Unexpected character data during XML During XML parsing for object %1, character 1. Internal software error. 1. Call your Beckman Coulter
parsing. data was received with no XML object Representative.
defined: %2.
Unexpected document end during XML An end document was received with XML 1. Internal software error. 1. Call your Beckman Coulter
parsing. objects still active during parsing for Representative.
object %1.
Unexpected end tag during XML parsing. An end tag %2 was received with no active 1. Internal software error. 1. Call your Beckman Coulter
XML object defined during parsing for Representative.
object %1.
Unexpected framework error. Call your Error: %1 Stack: %2. 1. Internal software error. 1. Call your Beckman Coulter
Beckman Coulter Representative. Representative.
Unexpected start tag during XML A start tag %2 was received with no active 1. Internal software error. 1. Call your Beckman Coulter
parsing. XML object defined during parsing for Representative.
object %1.
Unsupported result type received from None. 1. Internal software error. 1. Call your Beckman Coulter
System Manager. Representative.
629743AE
Table 10.4 Error Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Customer Troubleshooting

VCSn MRC (Host ID: 20) not responding. Command sent to VCSn MRC board was not One of the following components is 1. Power off and power on SPM
acknowledged. disconnected or has experienced a fault:
This can occur during power up or hardware 1. CAN cable
configuration retrieval. 2. Module ID board
3. COMM I/F card
4. VCSn MRC board
5. MRC software application corrupted.
VME POST failed for CBC SCA card. Power-on VME diagnostics reported fault for 1. Faulty interconnect. 1. Power off and power on SPM
CBC SCA card. 2. Defective card.
VME POST failed for Comm I/F card. Power-on VME diagnostics reported fault for 1. Faulty interconnect. 1. Power off and power on SPM
Comm I/F card. 2. Defective card.
VME POST failed for VCSn SCA card. Power-on VME diagnostics reported fault for 1. Faulty interconnect. 1. Power off and power on SPM
VCSn SCA card. 2. Defective card.
Verification bar code read was not SPM %1. 1. Bar-code label quality. 1. Inspect label placement.
successful. 2. Label placement on the tube.
Waste container is full. The SPM has detected that the waste 1. Waste container is full 1. Check the waste containers and
container is full. 2. Waste sensor not properly replace or empty any waste
connected container that is full.
2. Check that waste sensor is properly
installed in container
Writing to barcode reader failed. Unable to write to barcode reader. 1. Internal software error. 1. Call your Beckman Coulter
Representative.

Event Messages from the System Manager


XML is missing the format specification. XML is missing the format specification 1. Internal software error. 1. Call your Beckman Coulter
Object name: %1. Representative.
XML parsing error. XML error parsing object %1 at line %2, 1. Internal software error. 1. Call your Beckman Coulter
column %3. Representative.
Message: %4.
XML parsing error: duplicate start tag in The same XML start tag %2 was received 1. Internal software error. 1. Call your Beckman Coulter

Troubleshooting
object. more than once in object %1. Representative.
XML parsing error: no attributes found. Error parsing XML string for element %1: no 1. Internal software error. 1. Call your Beckman Coulter
attributes defined. Representative.
10-91

10
10-92

Table 10.5 Warning Event Messages

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Action

A control has failed. Auto Stop is not The following control failed with %1: SPM: %2 1. Defective or expired control. 1. Try another control.
enabled. Lot number: %3 Type: %4 Level: %5. 2. SPM is not operating correctly. 2. Call your Beckman Coulter
Representative.
An XML parser warning has occurred. An XML parser warning has occurred: Object 1. Internal software error. 1. Call your Beckman Coulter
name: %1 Warning message: %2. Representative.
An XML parsing error: unknown start tag An unknown start tag was parsed: %2 in 1. Internal software error. 1. Call your Beckman Coulter
in object. object %1. Representative.

An XML parsing warning: unknown end An XML end tag was received </%1> while 1. Internal software error. 1. Call your Beckman Coulter
tag in object. parsing object %2, but there was no Representative.
corresponding start tag for this element.
An unknown attribute was encountered An unknown attribute %2 was encountered 1. Internal software error. 1. Call your Beckman Coulter
while parsing object. while parsing object %1. Representative.

Application exited while backup was in Current backup may not be useable. 1. Backup was interrupted. 1. Retry backup.
progress.
Backup operation failed. Error saving the registry. 1. Internal software error. 1. Call your Beckman Coulter
Representative.
CBC calibrator lot has expired. Calibrator expiration date is %1. 1. Calibrator has expired. 1. Check the Calibration Setup screen
2. Expiration date was entered and ensure the correct expiration
incorrectly. date has been entered.
2. Replace calibration material with one
that has not expired.
Cannot process QC specimen. The DxH control file for specimen %1 could 1. Reused reserved Beckman Coulter 1. Delete the existing control
not be created because there is an existing control label information. configuration file and set up a new
other or patient control file with the lot control file or relabel a new control to
number. match the correct control file.
Cannot process QC specimen. The DxH control file for specimen %1 could 1. Auto configuration was disabled 1. Enable automatic control file
not be created because the auto when an unconfigured control was configuration or manually configure
configuration for the DxH control type is presented. control file.
disabled.
Conflicting decision rules found. Some parameters were disabled for Check Decision Rules for consistency.
existing decision rules.
Conflicting decision rules were disabled. Conflicting decision rules: %1. Some parameters were disabled for Check Decision Rules for consistency.
629743AE

existing decision rules.


Table 10.5 Warning Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Action

Control specimen not processed. The following control was skipped: SPM: %1 1. Invalid control label. 1. Verify that you are using the correct
Lot number: %2 Type: %3 Level: %4. 2. Verification read failed. control.
2. Run the Bar-code Reader Alignment
procedure.
Diluent source switched. The SPM has switched from %1 supply to %2 None 1. Check the waste containers and
supply. replace or empty any waste
container that might be almost full.
Download received while batching is 1. Batching enabled while downloading 1. Disable either LIS or batching.
enabled. from LIS. These modes are
incompatible.
Flow-cell clog. Outputs from flow-cell transducers exceeded 1. Obstructed sample line or flow cell. 1. Verify results for NRBC and/or Retic if
operational limits during Diff analysis on 2. Air in pending sample line entering available, if Flow cell clog is indicated
SPM %1. flow cell. on multiple test modes perform flush
3. Specimen interference. flow cell procedure.
2. Verify LATRON recovery.
Flow-cell clog. Outputs from flow-cell transducers exceeded 1. Obstructed sample line or flow cell. 1. If Diff and/or Retic are available,
operational limits during NRBC analysis on 2. Air in pending sample line entering check if flow-cell clog is indicated on
SPM %1. flow cell. multiple test modes. Perform flush
3. Specimen interference. flow cell procedure.
2. Verify LATRON control recovery.
Flow-cell clog. Outputs from flow-cell transducers exceeded 1. Obstructed sample line or flow cell. 1. verify results for NRBC and/or Diff if
operational limits during Retic analysis on 2. Air in pending sample line entering available, if Flow cell clog is indicated
SPM %1. flow cell. on multiple test modes perform flush

Event Messages from the System Manager


3. Specimen interference. flow cell procedure 2. Verify LATRON
recovery
IQAP export cancelled: system restart. An attempt to export IQAP files was cancelled 1. System shutdown interrupted 1. Power on the System Manager.
because the system shut down before the transfer. 2. Request the IQAP export again when
transfer was completed. the system is running.
Request the IQAP export again.
Control type / Lot number %2 SPM: %1.

Troubleshooting
10-93

10
Table 10.5 Warning Event Messages (Continued)
10-94

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Action

IQAP export failed: RMS service not An attempt to export IQAP files failed 1. Could not contact Remote 1. Request the IQAP export again. If the
available. because the RMS service could not be Management System service. failure recurs, call your Beckman
contacted. Coulter Representative.
Request the IQAP export again.
If the failure recurs, call your Beckman
Coulter Representative.
Control type / Lot number %2 SPM: %1.
IQAP export failed: RMS transfer not An attempt to export IQAP files failed 1. Could not complete Remote 1. Request the IQAP export again. If the
completed. because the RMS file transfer could not be Management System file transfer. failure recurs, call your Beckman
completed. Coulter Representative.
Request the IQAP export again.
If the failure recurs, call your Beckman
Coulter Representative.
Control type / Lot number %2 SPM: %1.
IQAP export failed: duplicate transaction. An attempt to export IQAP files failed 1. Attempt to export IQAP while 1. Wait for completion of the export in
because a duplicate transaction was in another export in progress. progress and request the IQAP
progress. export again. If the failure recurs, call
Request the IQAP export again. your Beckman Coulter
Representative.
If the failure recurs, call your Beckman
Coulter Representative.
Control type / Lot number %2 SPM: %1.
IQAP export failed: not enrolled in RMS. An attempt to export IQAP files failed 1. System not enrolled in Remote 1. Enroll this system installation in the
because the system was not enrolled in the Management System. Beckman Coulter Remote
RMS. Management System.
Enroll this system installation in the Beckman
Coulter RMS.
Control type / Lot number %2 SPM: %1.
IQAP export failed: system error. An attempt to export IQAP files failed 1. Internal software error. 1. Call your Beckman Coulter
because of an internal system error. Representative.
Call your Beckman Coulter Representative.
Control type / Lot number %2 SPM: %1.
629743AE
Table 10.5 Warning Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Action

Incompatible presentation mode for A control specimen presented automatically 1. Control was presented incorrectly. 1. Retry operation using correct
control specimen. was using a specimen type that can only be presentation.
processed manually.
The control was not processed: SPM: %1 Lot
number: %2 Type: %3 Level: %4.
Incompatible presentation mode for A specimen presented automatically was 1. Specimen was presented incorrectly. 1. Retry operation using correct
specimen. using a specimen type or a test that can only presentation.
be processed manually.
The specimen could not be processed.
Specimen ID: %1.
Maximum number of No Match events Maximum number of consecutive No Match 1. Representation of specimens 1. Check the No Match Auto Stop
reached. events has been reached. previously processed. setting to ensure it has been
A No Match event occurs when no test order 2. LIS download was not successful configured correctly.
is identified for a specimen that has been 3. Bar code reader configuration 2. Check that the host orders are
presented. accepted by the instrument and
logged in the Worklist Pending list.
3. Check the bar code label on the
specimen tube to ensure it is not
damaged.
4. Check that the bar code label
information in the Worklist Pending
list matches the bar code on the
specimen as read by the instrument.
5. Check that the bar code reader is

Event Messages from the System Manager


reading the bar code labels on the
specimen tubes.
Maximum number of No Read events The maximum number of consecutive No 1. Bar code label configuration 1. Check the No Read Auto Stop setting
reached. Read events has been reached for a bar code 2. Bar code reader failure to ensure it has been configured
reader %1. 3. Orientation of specimens in cassette correctly.
A No Read event occurs when a bar code 2. Check the bar code label on the
reader fails to read the specimen ID. specimen tube to ensure it is not

Troubleshooting
damaged.
3. Check that the bar code reader is
reading the bar code labels on the
specimen tubes.
10-95

10
Table 10.5 Warning Event Messages (Continued)
10-96

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Action

Maximum number of Partial Aspiration Maximum number of consecutive Partial 1. Plugged aspiration probe 1. Check the Partial Aspiration Auto
events reached. Aspiration events has been reached. Stop setting to ensure it has been
A Partial Aspiration event occurs when the configured correctly.
SPM is unable to aspirate sufficient sample to 2. Verify there is sufficient sample in
analyze the specimen. the tube.
3. Perform Dispense Diluent procedure
to verify the aspiration path is clear
and does not contain any blockages.
4. Run the Verify Blood Detector
diagnostic procedure.
Maximum number of Total Voteout Maximum number of consecutive Total 1. Insufficient CBC lyse reagent 1. Verify that the CBC Lyse reagent is
events reached. Voteout events for patient processing has 2. Plugged aperture being dispensed to the WBC bath.
been reached for test parameter %1. 2. Check the Voteout Auto Stop setting
to ensure it has been configured
correctly.
3. Perform the Zap Aperture diagnostic
procedure.
Maximum number of consecutive partial Maximum number reached for aperture %1 1. Plugged apertures. 1. Run Zap Apertures procedure.
voteouts reached. and test parameter %2. 2. Run Clean Apertures procedure.
Operator ID was skipped when restoring Operator ID: %1 was not restored due to a 1. Operator's role has been modified 1. Upon completion of the restore,
configuration. conflict This operator already exists in the since the backup was created. verify the operator's role and access
system. level is correct.
For this operator following attributes in saved 2. If necessary, modify the operator's
configuration are different from the role and access level.
attributes that already exists in system,
given below in parenthesis: %2.
Prime procedure was not successful. Procedure was interrupted due to SPM status. 1. Reagent depleted. 1. Inspect reagent levels and replace
2. Waste full. containers as necessary.
2. Inspect waste levels and replace
containers as necessary.
Processed specimen was not removed on Manually processed specimen was not None 1. Remove the specimen from the
time. removed from the manual station within manual station.
required 3 minutes.
629743AE
Table 10.5 Warning Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Action

Reagent is low. The SPM has detected that the %1 reagent is None 1. Check the reagents on the system
almost depleted. and replace any reagents that might
be almost empty.
Reagent is low. The SPM has detected that %1 supply is None 1. Replace reagent if planning
almost depleted. extended walk-away time
Scheduled backup not performed. Another backup was in progress. 1. Attempted backup while backup was 1. Allow the current backup to run
in progress. without interruption.
Scheduled procedure skipped. %R(%1) procedure did not start because SPM 1. SPM performing QA procedure. 1. Run the procedure manually.
was busy. 2. SPM processing patient specimens.
3. SPM in maintenance/diagnostics
mode.
4. System Manager could not
communicate with SPM.
Scheduled procedure skipped. %R(%1) procedure did not start because SPM 1. SPM performing QA procedure. 1. Run the procedure manually.
was busy. 2. SPM processing patient specimens.
3. SPM in maintenance/diagnostics
mode.
4. System Manager could not
communicate with SPM.
Scheduled procedure skipped. %R(%1) procedure did not start. 1. SPM performing maintenance 1. Run the procedure manually.
Reason %R(%2). procedure.

Scheduled procedure skipped. %R(%1) procedure did not start because SPM 1. SPM performing QA procedure. 1. Run the procedure manually.

Event Messages from the System Manager


was busy. 2. SPM processing patient specimens.
3. SPM in maintenance/diagnostics
mode.
4. System Manager could not
communicate with SPM.
Scheduled procedure skipped. %R(%1) procedure did not start because SPM 1. SPM performing QA procedure. 1. Run prime.
was in %R(%2) state. 2. SPM processing patient specimens.

Troubleshooting
3. SPM in maintenance/diagnostics
mode.
4. System Manager could not
communicate with SPM.
10-97

10
Table 10.5 Warning Event Messages (Continued)
10-98

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Action

Scheduled procedure skipped. %R(%1) procedure did not start because 1. Cleaner was not removed from SPM. 1. Run prime.
cleaner is in SPM. 2. Run procedure manually.
Shutdown procedure incomplete. SPM cannot go online. 1. Waste container full. 1. Check event log for cause of failure.
2. Cleaner depleted. 2. Correct the problem.
3. Run Prime or rerun Shutdown
procedure.
System backup not performed. SPM was A scheduled automatic backup was not 1. Attempted backup while instrument 1. Reschedule a backup when the
busy. performed. was running. instrument is not busy
The SPM was busy each time the backup was
rescheduled.
System unexpectedly exited while A backup operation started at %1 on %2 was 1. Backup was interrupted. 1. Retry backup.
backup was in progress. unexpectedly interrupted.
Current backup may not be useable.
Test panel definition contains an A test panel definition received from the 1. Internal software error. 1. Call your Beckman Coulter
unrecognized specimen type. System Manager contained an unrecognized Representative.
specimen type.
Test: %2 Specimen type: %1.
The control lot you are running has SPM: %1 Lot number: %2 Type: %3 1. Control expired. 1. Replace the control.
expired. Level: %4.

Unable to access PI CPU NVRAM Cannot read or write to the NVRAM. 1. NVRAM experienced a fault 1. Power off and power on SPM
Unexpected CDATA received during XML Unexpected CDATA element received during 1. Internal software error. 1. Call your Beckman Coulter
parsing. XML parsing for object %1. Representative.

Unexpected characters during XML Unexpected character data received during 1. Internal software error. 1. Call your Beckman Coulter
parsing. XML parsing for object %1. Representative.
Character date: %2.
Unprocessed specimen was not removed Unprocessed specimen was not removed None 1. Remove the specimen from the
on time. from the manual station within required 3 manual station.
minutes.
XML parsing warning. XML warning parsing object %1 at line %2, 1. Internal software error. 1. Call your Beckman Coulter
column %3. Representative.
629743AE

Message: %4.
629743AE

Table 10.6 Info Event Messages

Description Detailed Description Probable Cause Action

A report could not be generated: No data No data source was found for the table %2 in 1. Installation problem. 1. Call your Beckman Coulter
source found. report %1. Representative.
The report could not be generated.
A report could not be generated: The sub-report %2 could not be found in the 1. Installation problem. 1. Call your Beckman Coulter
Required sub-report not found. report %1. Representative.
The report could not be generated.
Auto report generation error. Automatic report failed to print. 1. Internal software error. 1. Call Beckman Coulter
Error occurred during creation of report. Representative.

CBC calibrator lot mismatch. The calibrator lot %1 entered on the 1. Incorrect calibrator setup. 1. Check the Calibration Setup screen
Calibration Setup screen does not match the and ensure the proper calibrator lot
calibrator lot presented. number was entered.
2. Verify that the lot number of the
calibrator being processed matches
the lot number of the Calibration
Setup screen.
Data summary Daily Checks: unknown Parameter name: %1. 1. Internal software error. 1. Call your Beckman Coulter
parameter. Representative.

Failed reading data while trying to save Failed reading from stream while creating file 1. Internal software error. 1. Call your Beckman Coulter
to file. for export. Representative.
Return value from read function:%1 Detail
description:%2.

Event Messages from the System Manager


Failed to add data to report job. Report Failed to add data %1 to report job for data 1. Installation problem. 1. Call Beckman Coulter
job cancelled. set %2. Representative.
Datasets probably not defined for this report
job.
Failed to process report. Failed to process report job. 1. Internal software error. 1. Call your Beckman Coulter
Report title %1 Report name %2. Representative.

Troubleshooting
Host data error (Patient record). Invalid Demographics shall not be processed. 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
data for patient with ID: %1 Field: %2 Invalid Data: %3 Reason: %4. host.

Host data error (Patient record). Invalid Demographics will not be processed. 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
10-99

patient ID. Field: %1 Invalid data: %2 Reason: %3. host.

10
Table 10.6 Info Event Messages (Continued)
10-100

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Action

Host data error (Test Order record). Invalid field description: Order: %1 Field: %2 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
Invalid data: %3 Reason: %4. host.
Host data error (Test Order record). Test order is rejected. 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
Invalid data for test order: %1. Primary ID: %2 Specimen type: %3 host.
Requisition number: %4 Patient ID: %5.
Host data error (Test Order record): Test order is rejected. 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
invalid data in required field. Field: %1 Invalid data: %2 Reason: %3. host.

Host data error: Invalid data received in Field: %1, Invalid Data: %2, Reason: %3. 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
Comment record. host.

Host data error: cannot create new test Test order is rejected as active test order 1. Test order already exists. 1. Contact the LIS vendor.
order. exists.
Existing test order: Primary ID %1 Specimen
type: %2 Requisition number: %3 Patient
ID: %4 Tests: %5 Rejected test order: Primary
ID: %6 Specimen type: %7 Requisition
number: %8 Patient ID: %9 Tests: %10.
Host data error: comment not associated Comment Text: %1 Patient ID: %2. 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
with patient demographics. host.

Host data error: comment not associated Comment Text: %1 Primary Identifier: %2. 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
with specimen. host.

Host data error: duplicate tests cannot be Duplicate tests (%6) cannot be added for: 1. Duplicate test panels in the same 1. Contact the LIS vendor.
added. Primary ID: %1 Specimen type: %2 order record.
Requisition number: %3 Patient ID: %4
Tests: %5.
Host data error: invalid data received in Field: %1, Invalid Data: %2, Reason: %3. 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
Header record. host.

Host data error: missing primary Primary identifier must be assigned to 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
identifier. process the specimen. host.
Missing primary identifier for: Secondary
ID: %1 Specimen type: %2 Requisition
number: %3 Patient ID: %4 Tests: %5.
629743AE
Table 10.6 Info Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Action

Host data error: specimen ID is reserved Specimen ID cannot be the same as reserved 1. Specimen ID is reserved for control. 1. Contact the LIS vendor.
for control ID. control ID.
Test order is rejected for: Primary ID: %1
Specimen type: %2 Requisition number: %3
Patient ID: %4.
Host data error: specimen type cannot Specimen type cannot be changed as in 1. Attempt to change specimen type 1. Contact the LIS vendor.
be changed. progress or completed tests exist. while test in progress.
Existing test order: Primary ID %1 Specimen
type: %2 Requisition number: %3 Patient
ID: %4 Tests: %5 Rejected test order, Primary
ID: %6 Specimen type: %7 Requisition
number: %8 Patient ID: %9 Tests: %10.
Host data error: specimen type cannot Test order is rejected as specimen type 1. Specimen type does not match 1. Contact the LIS vendor.
be modified. cannot be changed. existing order.
Existing test order: Primary ID %1 Specimen
type: %2 Requisition number: %3 Patient
ID: %4 Tests: %5 Rejected test order: Primary
ID: %6 Specimen type: %7 Requisition
number: %8 Patient ID: %9 Tests: %10.
Host data error: specimen type not Specimen type %2 is not supported. 1. Specimen type is unknown. 1. Contact the LIS vendor.
supported. Test order is rejected for: Primary ID: %1
Requisition number: %3 Patient ID: %4.
Host data error: test panel(s) not Test panel(s) %5 not supported or enabled. 1. Unsupported or disabled panel. 1. Contact the LIS vendor.

Event Messages from the System Manager


supported or enabled. Test order is rejected for, Primary ID: %1
Specimen type: %2 Requisition number: %3
Patient ID: %4.
Host data error: tests not added. Primary ID %1, test: %2, reason: %3. 1. Test was already in progress. 1. Call your Beckman Coulter
2. Wrong panel for the specimen type. Representative.
3. Unsupported panel.
4. Panel disabled.

Troubleshooting
5. Exceeded maximum number of runs
for specimen.
6. Internal system error.
10-101

10
Table 10.6 Info Event Messages (Continued)
10-102

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Action

Host data error: tests not canceled. Primary ID: %1, test: %2, reason: %3. 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
host.
Host data error: tests not consistent with Test order is rejected as the specimen type is 1. Specimen type does not match test 1. Contact the LIS vendor.
specimen type. not consistent with the tests ordered. order.
Existing test order: Primary ID: %1 Specimen
type: %2 Requisition number: %3 Patient
ID: %4 Tests: %5 Rejected test order: Primary
ID: %6 Specimen type: %7 Requisition
number: %8 Patient ID: %9 Tests: %10.
Host data error: transmitted patient ID is Test order is rejected as transmitted patient 1. Specimen ID was being reused for 1. Delete the existing order from the
different. ID is different from the existing patient ID. different patient. Worklist.
Existing test order: Primary ID: %1 Specimen 2. Retransmit the order from the LIS.
type: %2 Requisition number: %3 Patient
ID: %4 Tests: %5 Rejected test order: Primary
ID: %6 Specimen type: %7 Requisition
number: %8 Patient ID: %9 Tests: %10.
Host parsing error (Header record): Header record must contain at the most five 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
record length invalid. characters. host.

Host parsing error: <CR><LF> character Parsing Comment record: trailing carriage 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. return <CR> and line feed <LF> characters host.
missing.
Host parsing error: <CR><LF> character Parsing Patient record: trailing carriage return 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. <CR> and line feed <LF> characters host.
missing.
Host parsing error: <CR><LF> character Parsing record: trailing carriage return <CR> 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. and line feed <LF> characters missing. host.

Host parsing error: <CR><LF> character Parsing Test Order record: trailing carriage 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. return <CR> and line feed <LF> characters host.
missing.
Host parsing error: <CR><LF> pair Parsing Header record: trailing carriage 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. return <CR> and line feed <LF> characters host.
missing.
629743AE
Table 10.6 Info Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Action

Host parsing error: <ETB>/<ETX> Parsing Comment record: end of 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
character missing. transmission block <ETB> or end of test host.
<ETX> character missing.
Host parsing error: <ETB>/<ETX> Parsing Header record: end of transmission 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
character missing. block <ETB> or end of test <ETX> character host.
missing.
Host parsing error: <ETB>/<ETX> Parsing Patient record: end of transmission 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
character missing. block <ETB> or end of test <ETX> character host.
missing.
Host parsing error: <ETB>/<ETX> Parsing record: end of transmission block 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
character missing. <ETB> or end of test <ETX> character host.
missing.
Host parsing error: <ETB>/<ETX> Parsing Test Order record: end of 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
character missing. transmission block <ETB> or end of test host.
<ETX> character missing.
Host parsing error: <STX> character Parsing Header record: start of text <STX> 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. character missing. host.

Host parsing error: <STX> character Parsing Patient record: start of text <STX> 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. character missing. host.

Host parsing error: <STX> character Parsing record: start of text <STX> character 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. missing. host.

Host parsing error: <STX> character Parsing Test Order record: start of text 1. Data incorrectly formatted by the 1. Contact the LIS vendor.

Event Messages from the System Manager


missing. <STX> character missing. host.

Host parsing error: Header record Header record is missing in LIS message. 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing in LIS message. host.

Host parsing error: Header record out of Header record is not the first record in an LIS 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
sequence in LIS message. message. host.

Host parsing error: Patient record missing Patient record missing in LIS message. 1. Data incorrectly formatted by the 1. Contact the LIS vendor.

Troubleshooting
in LIS message. host.

Host parsing error: Terminator record 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing in LIS message. host.
10-103

10
Table 10.6 Info Event Messages (Continued)
10-104

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Action

Host parsing error: field delimiter Parsing Comment record: field delimiter 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. missing. host.

Host parsing error: field delimiter Parsing Header record: field delimiter 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. missing. host.

Host parsing error: field delimiter Parsing Patient record: field delimiter 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. missing. host.

Host parsing error: field delimiter Parsing Terminator record: field delimiter 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. missing. host.

Host parsing error: field delimiter Parsing Test Order record: field delimiter 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. missing. host.

Host parsing error: incorrect CRC. Parsing Comment record: record contains 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
incorrect CRC. host.
2. Faulty cable connection.
Host parsing error: incorrect CRC. Parsing Header record: record contains 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
incorrect CRC. host.
2. Faulty cable connection.
Host parsing error: incorrect CRC. Parsing Patient record: record contains 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
incorrect CRC. host.
2. Faulty cable connection.
Host parsing error: incorrect CRC. Parsing record: record contains incorrect 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
CRC. host.
Host parsing error: incorrect CRC. Parsing Test Order record: record contains 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
incorrect CRC. host.
2. Faulty cable connection.
Host parsing error: invalid escape Invalid escape sequence in record field. 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
sequence. host.

Host parsing error: invalid sequence Invalid sequence number received in 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
number. Comment record. host.

Host parsing error: invalid sequence Invalid sequence number received in Patient 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
number. record. host.
629743AE
Table 10.6 Info Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Action

Host parsing error: invalid sequence Parsing Terminator record: invalid sequence 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
number. number. host.

Host parsing error: invalid sequence Invalid sequence number received in Test 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
number. Order record. host.

Host parsing error: missing component Parsing Test Order record: missing 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
delimiter. component delimiter in Tests field. host.

Host parsing error: record terminator Parsing Comment record: record terminator 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
character missing. character missing. host.

Host parsing error: record terminator Parsing Patient record: record terminator 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
character missing. character missing. host.

Host parsing error: record terminator Parsing record: record terminator character 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
character missing. missing. host.

Host parsing error: record terminator Parsing Test Order record: record terminator 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
character missing. character missing. host.

Host parsing error: record type not Parsing LIS record: record type not 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
supported. supported. host.

Host parsing error: start of text <STX> Parsing Comment record: start of text <STX> 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
character missing. character missing. host.

Host parsing error: terminator character Parsing Header record: record terminator 1. Data incorrectly formatted by the 1. Contact the LIS vendor.
missing. character missing. host.

Event Messages from the System Manager


Invalid CDATA element in report job Missing end tag for the CDATA element 1. Internal software error. 1. Call your Beckman Coulter
result value. enclosing the report value string in a report Representative.
job submitted by the System Manager.
Invalid CDATA elements were found in a The result value string in a report job from the 1. Installation problem. 1. Call your Beckman Coulter
report job. System Manager contained invalid top-level Representative.
CDATA elements.
Invalid data for report job. An invalid XML data string was used in a 1. Installation problem. 1. Call your Beckman Coulter

Troubleshooting
report job. Representative.
Report title: %1 Report name: %2.
10-105

10
Table 10.6 Info Event Messages (Continued)
10-106

Event Messages from the System Manager


Troubleshooting
Description Detailed Description Probable Cause Action

Invalid data set used in report job. An undefined or invalid data set was used in 1. Installation problem. 1. Call your Beckman Coulter
a report job. Representative.
Report name: %1 Report title: %2 Data
set: %3.
Invalid log on to System Manager. Invalid log on to System Manager: Operator 1. System Manager logon failed. 1. Contact your lab administrator.
ID: %1.
Invalid or missing report file for report An invalid or missing report file was used in a 1. Installation problem. 1. Call your Beckman Coulter
job. report job. Representative.
Report title: %1 Report job name: %2 Report
file: %3.
Invalid report request received from XML parsing failure for a report job received 1. Installation problem. 1. Call your Beckman Coulter
System Manager. from System Manager. Representative.

Manual backup operation failed. Error: %1. 1. Attempted backup while instrument 1. Perform backup when the
was running. instrument is not busy
Printing error: out of paper. Printing error: the printer is out of paper. 1. Printer out of paper 1. Fill paper supply.
Report name: %1, requested time: %2 failed
to print.
Please insert more paper in the printer or
select a different printer.
Report data set not defined. Report job The report data set definition %1 could not 1. Installation problem. 1. Call Beckman Coulter
creation failed. be found in the database. Representative.
The report job could not be submitted.
Call your Beckman Coulter Representative.
Report failed. The report failed to print. 1. Internal software error. 1. Call Beckman Coulter
Report name: %1, requested time: %2 Please Representative.
check the printer for a paper jam or a printer
malfunction.
629743AE
Table 10.6 Info Event Messages (Continued)
629743AE

Description Detailed Description Probable Cause Action

Report failed. The report failed to print because of a system 1. Internal software error. 1. Call your Beckman Coulter
error. Representative.
Report name: %1, requested time: %2 Please
check the error entry in the general history
log.
Specimen ID verification failure for a The system has determined that an ID 1. Invalid bar-code label. 1. Verify the bar-code label.
specimen. verification failure has occurred. 2. Verification read failed. 2. Perform Bar-code Reader Alignment
Therefore, the specimen (%1 %2) could not procedure.
be positively identified and specimen 3. Perform Bar-code Read Rate test.
processing will be skipped.

Event Messages from the System Manager


Troubleshooting
10-107

10
Troubleshooting
Event Messages from the System Manager

Event Messages from the System Manager that Require No Action


Error Messages, Warning Messages and Informational Messages are listed in the following tables.
The Error Messages trigger an audible and visual alarm. The Warning Messages trigger a yellow
visual alarm. The Informational Messages do not trigger an audible or visual alarm. The tables in
this section are: Table 10.7, Error Event Messages, Table 10.8, Warning Event Messages. and
Table 10.9, Info Event Messages.

In the tables that follow, the % variable will be replaced by actual values when the messages occur
on the System Manager.

Table 10.7 Error Event Messages

Description Detailed Description Probable Cause

ALARM TEST. ALARM TEST %1. None


Added missing operating limit for test. Test name: %1 low limit: %2 high limit: %3. None
Attempt to submit specimen order failed. Attempt to submit a specimen order to the None
System Manager failed for specimen %1.
Error code: %2.
Communication error with MRC board or Communication error while accessing MRC or 1. CAN bus integrity is questionable
SCA DSP. SCA-DSP resource (Host ID: %1). (Applicable to MRC only)
2. MRC application is corrupted.
(Applicable to MRC only).
3. MRC board or COMM I/F card fault.
(Applicable to MRC only)
4. SCA-DSP application is corrupted.
(Applicable to SCA-DSP only)
Communication error with MRC board or Communication error while accessing MRC or 1. CAN bus integrity is questionable
SCA DSP. SCA-DSP resource (Host ID: %1). (Applicable to MRC only)
2. MRC application is corrupted.
(Applicable to MRC only).
3. MRC board or COMM I/F card fault.
(Applicable to MRC only)
4. SCA-DSP application is corrupted.
(Applicable to SCA-DSP only)
Communications failure transmitting test Transmission of test order for specimen %1 None
order for specimen. to the System Manager failed, with error
code %2.
Controls configuration restore. Checksum mismatch ignored by registry None
setting.
Created missing System Manager Parameter name: %1. None
parameter.
Decision rules restore. Checksum mismatch ignored by registry None
setting.
Delete specimen request failed for Delete specimen request command to the None
specimen. System Manager failed for specimen %1.
Error code: %2.
Event test System Error: Error %1. None
Exceeded maximum A/D devices for %1 This MRC has exceeded the maximum None
MRC (Host ID: %2). number of A/D devices allowed per MRC.

10-108 629743AE
Troubleshooting
Event Messages from the System Manager 10

Table 10.7 Error Event Messages (Continued)

Description Detailed Description Probable Cause

Failed Processing INF File. System has detected a problem processing 1. Corrupted INF/DAT file
INF file: %1 during replay.
Failed to publish specimen order for Attempt to publish a specimen order to the None
specimen. System Manager for specimen %1 failed.
Error code: %2.
Failed to read group definitions file. Attempt to read the parameter groups None
definition file failed.
Error: %1.
General Error test event. General Error test event. None
Host error: serial port not initialized. Error in initializing serial port. 1. Hardware failure.
Incorrect board detected for %1 MRC An incorrect board was connected to 1. SPI cable swapped at MRC.
(Host ID: %2). \r\nExpansion Port: %3.
\r\nExpected board: %4.
\r\nDetected board: %5.
Invalid label reuse of specimen ID. The label for specimen %1 contained NOTE: This is a later stage requirement
demographic information for a patient ID %2. to accept and handle 2D barcodes with
This patient ID did not match the patient ID demographics on the tube. This will not
defined in the active test order for appear in first release
specimen %1.
The specimen could not be processed.
Launch Application Error. An error occurred launching a Access 2 None
application: %1.
Maximum number of Tube Position ID No Maximum number of consecutive Tube
Read events reached. Position Id No Read has been reached.
Maximum number of consecutive rerun Secondary ID in the first run did not match 1. Specimen tube was rerun in a
secondary ID verification errors reached. secondary ID in a rerun. different cassette position.
2. Tube position bar code read error.
PS MRC (Host ID: 31) not responding. Command sent to PS MRC board was not One of the following components is
acknowledged. disconnected or has experienced a fault:
This can occur during power up or hardware 1. CAN cable
configuration retrieval. 2. Module ID board
3. COMM I/F card
4. PS MRC board
5. MRC software application corrupted.
Replaced display name for parameter The display name for parameter %1 is None
%1. incorrect and was replaced.
Old name: %2 New name: %3.
Solenoid is disconnected. ActivityID %1, CommandID %2, 1. Solenoid or circuit is open (connector
ResourceID %3. unplugged).
Solenoid is shorted. ActivityID %1, CommandID %2, 1. Defective solenoid.
ResourceID %3. 2. Salt bridge on solenoid expansion
board connection.
System - Daily Checks test event. System - Daily Checks test event. None
System - QA test event. System - QA test event. None

629743AE 10-109
Troubleshooting
Event Messages from the System Manager

Table 10.7 Error Event Messages (Continued)

Description Detailed Description Probable Cause

System - QC test event. System - QC test event. None


System - Supplies test event. System - Supplies test event. None
System - Xb test event. System - Xb test event. None
System Error test event. System Error test event. None
Regression Test Event.
System Patient test event. System Patient test event. None
Tests not available. Tests ordered for specimen %1 are not None
installed or not enabled at SPM %2.
Tests rejected: %3.

Table 10.8 Warning Event Messages

Description Detailed Description Probable Cause

Automated recovery was not successful. Command %1, SPM %2, Reason: %3. 1. Consumables are depleted.
Automated recovery was not successful. Command %1 on SPM %2 could not start 1. Power interruption.
because the SPM was disconnected or not
powered up.
Automated recovery was not successful. Command %1 on SPM %2 could not start None
because the SPM was in maintenance mode.
Automated recovery was not successful. Command %1 on SPM %2 could not start None
because the command is not available on the
SPM.
Default test order was used. No test order was defined for specimen %1. None
The default order for SPM %2 was used to
process the specimen.
Event test System Error: Warning %1. None
General Configuration restore. Checksum mismatch ignored by registry None
setting.
High event rate. Algorithm detected high event rate during 1. Specimen interference.
Diff analysis on SPM%1. 2. Sample conditioning issue (mixing,
temperature, reagent)
3. Improper probe alignment in mix
chamber.
High event rate. Algorithm detected high event rate during 1. Specimen interference.
NRBC analysis on SPM%1. 2. Sample conditioning issue (mixing,
temperature, reagent)
3. Improper probe alignment in mix
chamber.
High event rate. Algorithm detected high event rate during 1. Specimen interference.
Retic analysis on SPM%1. 2. Sample conditioning issue (mixing,
temperature, reagent).
3. Improper probe alignment in mix
chamber.

10-110 629743AE
Troubleshooting
Event Messages from the System Manager 10

Table 10.8 Warning Event Messages (Continued)

Description Detailed Description Probable Cause

Label test order used for specimen %1. No test order was defined for specimen %1. None
The test order read from the specimen label
was used to process the specimen.
Low event rate. Algorithm detected low event rate during Diff 1. Specimen interference.
analysis on SPM%1. 2. Sample conditioning issue (mixing,
temperature, reagent).
3. Partially obstructed sample line or
flow cell.
Low event rate. Algorithm detected low event rate during 1. Specimen interference.
NRBC analysis on SPM%1. 2. Sample conditioning issue (mixing,
temperature, reagent).
3. Partially obstructed sample line or
flow cell.
Low event rate. Algorithm detected low event rate during 1. Specimen interference.
Retic analysis on SPM%1. 2. Sample conditioning issue (mixing,
temperature, reagent).
3. Partially obstructed sample line or
flow cell.
Maximum number of Tube Position Id No Maximum number of Tube Position Id no read None
Read reached. has reached.
Partial INF/DAT export. The INF/DAT files for %1 of the %2 runs were 1. Unavailable INF/DAT files.
unavailable.
One or more runs for the following specimens
were not exported: %3.
Repair Command Initiation Failed Initiation of repair command %1 on SPM %2 None
failed.
Reason: %3.
System variables (CRC) from SPM cannot SPM system variables backup file stored on PI 1. NVRAM experienced a fault
be validated. CPU card is corrupt.
Variables have been recovered from
workstation.
System variables (time stamp) from SPM SPM system variables backup file stored on PI 1. PI CPU card replaced
cannot be validated. CPU card is corrupt.
Time stamp mismatch between PI CPU card
and workstation.
Variables have been recovered from
workstation.
Waste container is almost full. The SPM has detected that the waste 1. Waste container is almost full
container is almost full.

Table 10.9 Info Event Messages

Description Detailed Description Probable Cause

%1 %1. None
%1 %1. None

629743AE 10-111
Troubleshooting
Event Messages from the System Manager

Table 10.9 Info Event Messages (Continued)

Description Detailed Description Probable Cause

A control file has been deleted. None. None


A new control file has automatically been None. None
created.
A report could not be generated: Could not log on to the database for None
database log on failed. report %1.
The report could not be generated.
A report did not contain an expected The report %1 did not contain the expected None
image table. image table.
One or more images could not be included in
the report.
Added QC data. Item %1. None
Added configuration item. Item %1. None
Added patient data item. Item %1. None
All XM batches deleted in a group. All XM batches are deleted on %1, for None
group %2.
An existing order was used for a Batch mode is enabled and a specimen None
specimen. Batching is enabled. (%1 %2) had an existing order in the worklist.
The existing order was used instead of the
default order.
Auto Configure Control settings changed. None. None
Auto Stop configuration None
Automated recovery was successful. Command %1, SPM %2. None
BCI default limits restored. None. None
Bar code configuration changed on %1 None
CBC calibration accepted. CBC calibration procedure has been None
accepted with calibration lot %1 (expiration
date %2).
The specimens were presented in %3 mode.
The number of runs = %4.
CBC calibration factors were changed. CBC calibration factors were significantly None
changed by SPM %1 operator %2.
The reference values are WBC=%3 RBC=%4
HGB=%5 MCV=%6 PLT=%7 MPV=%8.
CBC calibration run details CBC calibration procedure has completed None
with calibration lot %1 (expiration date %2).
The specimens were presented in %3 mode.
CBC gain calibration status is: For %1, aperture %2. None
CALIBRATED. Factor was saved.
CBC gain calibration status is: EDITED. For %1, aperture %2. None
Factor was edited and saved.

10-112 629743AE
Troubleshooting
Event Messages from the System Manager 10

Table 10.9 Info Event Messages (Continued)

Description Detailed Description Probable Cause

CBC gain calibration status is: FAIL. For %1, aperture %2. None
Quality criteria was not satisfied.
Factor was not saved.
CBC gain calibration status is: FORCED For %1, aperture %2. None
CALIBRATION. Factor was saved contrary to
recommendation.
CBC gain calibration status is: PASS. For %1, aperture %2. None
Quality criteria was satisfied.
Factor update was not necessary.
Carryover procedure status. Carryover procedure on SPM %1 completed None
on %T(%2).
The final status is %R(%3).
Changed QC data. Item %1. None
Changed configuration item Decision New Decision Rule evaluation order: %1. None
Rule: evaluation order.
Changed configuration item Patient None. None
report.
Changed configuration item System None. None
Settings: system time.
Changed configuration item Test Unit None. None
Selection.
Changed configuration item. Item %1. None
Changed patient data item. Item %1. None
Configuration changed for SPM %1. None
Configuration changed for automatic %1 Daily Checks or Shutdown maintenance None
cycle on instrument %2 . procedure is scheduled to run at a particular
time and day(s) of the week.
This event logs the changes to current
configuration compared to the previously
existed configuration.
Consensus rules restored. None. None
Consumable on SPM. None
Control file modified. Control file: %1 was modified. None
Control runs deleted. Control runs: %1. None
Copy of event. Copy of event %1. None
Could not find required report data. The report could not be generated because 1. Data was probably deleted.
some of the required data could not be found
in the database.
The data has probably been deleted.
Report job: %1.
Daily Checks procedure successful. None

629743AE 10-113
Troubleshooting
Event Messages from the System Manager

Table 10.9 Info Event Messages (Continued)

Description Detailed Description Probable Cause

Data summary Daily Checks - test event. TypeOfCycle: %1 CycleDateTime: %2 None


Reason: %3 BackgroundCountData: %4
ReagentStatuses: %5
SubsystemStatuses: %6
UseTimeOfLastShutdown: %7.
Data summary Reproducibility test Data summary Reproducibility test None
event. event:%1.
Data summary XB test event. Data summary XB test event:%1. None
DataSummary - SystemChecks test TypeOfCycle: %1 CycleDateTime: %2 None
event. CycleTime: %3 Reason: %4
BackgroundCountData: %5
ReagentStatuses: %6
SubsystemStatuses: %7
UseTimeOfLastShutdown: %8.
Default test order changed on SPM %1. None
Deleted QC data. Item %1. None
Deleted configuration item. Item %1. None
Deleted patient data item. Item %1. None
Event test Audit Trail: Configuration %1. None
Event test Audit Trail: Patient Data %1. None
Event test Audit Trail: QC %1. None
Event test System Error: Info %1. None
Event test System: Maintenance %1. None
Event test System: QA %1. None
Event test System: QC %1. None
Event test System: Service %1. None
Event test System: Supplies %1. None
Event test System: System Status %1. None
Event test System: XB %1. None
Event test daily summary: system %1. None
checks
Event test data summary: consumables %1. None
Event(s) were deleted as part of auto- Event(s) %1. None
trimming process.
Event(s) were manually deleted. Event(s) %1. None
Eventd test System: Patient %1. None
Host data error: duplicate test order. Duplicate test order received, test order is None
rejected.
Existing test order: Primary ID: %1 Specimen
type: %2 Requisition number: %3 Patient
ID: %4 Tests: %5 Rejected test order: Primary
ID: %6 Specimen type: %7 Requisition
number: %8 Patient ID: %9 Tests: %10.

10-114 629743AE
Troubleshooting
Event Messages from the System Manager 10

Table 10.9 Info Event Messages (Continued)

Description Detailed Description Probable Cause

Host data error: tests not cancelled. Specimen not found. 1. Already deleted order was cancelled
Primary ID: %1 Specimen type: %2 by LIS.
Requisition number: %3 Patient ID: %4
Tests:%5.
Host: test order accepted in place of LIS-submitted test order is accepted in place None
default test order. of a default test order.
Default test order: Primary ID: %1 Specimen
type: %2 Requisition number: %3 Patient
ID: %4 Tests: %5 LIS submitted test order:
Primary ID: %6 Specimen type: %7
Requisition number: %8 Patient ID: %9
Tests: %10.
IQAP export succeeded IQAP export succeeded. None
Control type / Lot number %2 SPM: %1.
Manual backup failed. A backup operation was already in progress. 1. Attempted backup while backup was
in progress.
Manual backup operation started. None. None
Manual selection of flagging limit for test Primary ID: %1. None
order.
New control file created. None. None
New patient demographics created. Created new patient demographics for None
(%1, %2, %3) with patient ID (%4).
Operator access configuration created. Operator access configuration created None
for %1 by %2 First name: %3 Last name: %4
Access level: %5 Active status: %6.
Operator access configuration modified. Operator access configuration modified None
for %1 by %2 New first name: %3 Previous
first name: %4 New last name: %5 Previous
last name: %6 New access level: %7
Previous access level: %8 New active
status: %9 Previous active status: %10.
Password changed. Password changed for %1. None
Password reset. Password reset for %1 by %2. None
Patient ID was rectified. None. None
Patient demographics deleted. None. None
Patient demographics modified. Patient information was modified for None
(%1,%2,%3) patient ID (%4) Old: %5
New: %6.
Patient demographics were modified. Type: %1 Patient: %2. None
Prime procedure was successful. None
QC Lab limits changed. None. None
Reagent changed on SPM %1 None
Remote desktop sharing ended. RMSID %1. None
Remote desktop sharing started. RMSID %1. None

629743AE 10-115
Troubleshooting
Event Messages from the System Manager

Table 10.9 Info Event Messages (Continued)

Description Detailed Description Probable Cause

Remote management configuration None


update
Remote management enrollment failed. Remote management enrollment failed for None
instance %1: error code (%3) RMSID (%2).
Remote management enrollment Request submitted to enroll SPM %1 with None
submitted. instance number %2.
Remote management enrollment was None
successful.
Repeatability run details. Repeatability procedure has been accepted. None
The specimens were presented in %1 mode.
Repeatability summary. Repeatability procedure has been accepted. None
The specimens were presented in %1 mode.
The number of runs is %2.
Results summary of Daily Checks. None
SPM audible alarm setting changed. None
SPM prime succeeded. A prime occurs when transitioning from the None
idle state to an operational state.
Scheduled backup operation started. None. None
Settings changed on SPM %1. None
Shutdown procedure cancelled. None
Shutdown procedure successful. The cleaner was left in SPM for %1 minutes. None
Specimen identifier was not submitted Identifier for manually presented specimen None
on time. was not submitted within required 2 minutes.
Specimen was not found. Associated test Specimen: %1 was not found. None
order cannot be modified. Its associated test order cannot be modified.
Specimen ID: %1 Specimen type: %2
Requisition number: %3 Patient ID: %4 Tests
ordered: %5.
Specimen was not presented on time. Specimen was not placed in the manual None
station within required 3 minutes.
System Manager audible alarm setting None
changed.
System Manager shutdown request. None
System backup operation successful. None. None
System maintenance test event. System maintenance test event:%1. None
System recovery operation successful. System recovery operation successful at %1 None
on %2.
System service test event. System service test event:%1. None
Systematic/random review for control. The following control is reviewed with %1: None
SPM:%2 Lot number:%3 Type:%4 Level:%5.
Test order was collated. Primary ID: %1. None
Test order was deleted. Primary ID: %1. None

10-116 629743AE
Troubleshooting
Event Messages from the System Manager 10

Table 10.9 Info Event Messages (Continued)

Description Detailed Description Probable Cause

Test order was hidden. Primary ID: %1. None


Test order was modified. The data for the test order was modified. None
Primary ID: %1.
Test order was rejected. Primary ID: %1. None
Test order was released. Primary ID: %1. None
Test order was restored to release status. Primary ID: %1. None
The configuration has been successfully Configuration name: %1, items restored: %2. None
restored.
The configuration has been successfully Configuration name: %1, items saved: %2. None
saved.
The destination printer did not support The printer %1 does not support the paper 1. Printer does not support paper
the requested paper source. source %2 requested for report %3. source.
The default paper source was used.
Troubleshooting development test event. Troubleshooting development test event:%1. None
Troubleshooting host test event. Troubleshooting host test event:%1. None
User updated test configuration. None
Workload history has been cleared None
XB batches deleted. None. None
XB configuration has changed. None. None
XM batches deleted. None. None
XM configuration has changed. None. None

629743AE 10-117
Troubleshooting
Event Messages from the System Manager

10-118 629743AE
CHAPTER 11

Quality Assurance

Calibration

The calibration procedure consists of comparing instrument measurements to known values for
WBC, RBC, HGB, MCV, PLT and MPV. Calibration assures that an instrument's data output
accurately reflects sample input. Calibration is performed using materials based on or traceable to
known reference preparations or materials. In general, the procedure may indicate that the
instrument requires standardization, by first determining the deviation from 'calibrator reference',
and then applying recommended correction factors (CAL factors).

Your laboratory is responsible for the final calibration of the CBC parameters. Beckman Coulter
recommends COULTER S-CAL calibrator, or an exact equivalent, as an acceptable alternative to
whole blood calibration.

In the normal process of tracking data for an extended period of time, your laboratory can make a
specific decision to recalibrate a given parameter. Never adjust to a specific value for an individual
sample.

For best performance, verify and calibrate all the CBC parameters. The WBC differential, NRBC and
Retic parameters are calibrated by an authorized Beckman Coulter Representative in your
laboratory. The VCSn parameters do not require calibration in the laboratory.

NOTE Ensure your SPM is properly maintained and the apertures are clean prior to calibration.

When to Verify
You should verify the calibration of your instrument:

• As dictated by your laboratory procedures, local or national regulations


• When controls begin to show evidence of unusual trends
• When controls exceed the manufacturer’s defined acceptable limits
• If the average ambient room temperature changes more than 10°F or 12° C from the calibrating
temperature.

If the procedure indicates you need to calibrate, continue with the calibration procedure.

629743AE 11-1
Quality Assurance
Calibration

When to Calibrate
You should calibrate your instrument:

• At installation
• After the replacement of any component that involves dilution characteristics (such as the
BSV) or the primary measurements (such as the apertures)
• When advised to do so by your Beckman Coulter Representative.

• If you fail verify calibration procedure.

Calibrate with COULTER S-CAL Calibrator (Menu > QA > CBC Calibration)
NOTE Before you can start or restart the calibration process, the SPM must be offline.

Figure 11.1 CBC Calibration Screen

1 Select Calibration Setup on the CBC Calibration Screen to display the CBC Calibration Setup
dialog box.

11-2 629743AE
Quality Assurance
Calibration 11

Figure 11.2 CBC Calibration Setup Dialog Box

2 Type “10” in the Number of Aspirations text box.

3 Select Cassette Presentation Mode from the drop-down list.

4 Select BCI from the Calibrator Type drop-down list.

5 Select Upload and use the handheld bar-code scanner to scan the 2D bar code on the product
insert or type/select the following information:
• Lot #
• Expiration Date
• Reference Values

6 Select OK and follow the screen prompts.

629743AE 11-3
Quality Assurance
Calibration

7 Place the calibrator in a cassette.

8 Place the cassette in the input buffer and select OK.

9 Review the calibration results.

10 Select the Finish button at the bottom of the screen.

11 Verify your calibration with controls.

When the calibration procedure is complete, the CBC Calibration (Summary) screen displays.

Figure 11.3 CBC Calibration (Summary) Screen

The background color of the Factor %Diff, %CV, and Difference cells change color when the
presented value is out of the normal range as follows:
• Yellow for Difference indicates that the value is out of range, which means that calibration is
recommended.

11-4 629743AE
Quality Assurance
Calibration 11

• Red only applies to the %CV and indicates that the statistical value is NOT within range and the
system does NOT allow calibration.

When all results are acceptable, the Edit System Recommendations button at the bottom right hand
corner of the screen is enabled. This button allows to modify the calibration recommended by the
system by selecting or deselecting check boxes.

Calibrating with Whole Blood


NOTE Before you can start or restart the calibration process, the SPM must be offline.

Sample Requirements
For whole blood calibration, use a donor who:

• is not receiving medication


• has normal hematologic parameters
• has normal erythrocyte, leukocyte, and platelet morphology

You must draw into and store specimens in the proper amount of EDTA. If you use vacuum collection
tubes, ensure they are filled to correct capacity.

Obtain 20 normal, fresh whole blood specimens. You need enough of each to cycle three samples on
the comparator instrument and three samples on the DxH 800. If not using a comparator
instrument, the following reference methods are suggested:

• WBC and RBC - A single-aperture impedance cell counter such as a COULTER Z™Series cell
counter and the manufacturer’s recommended reagents. Macro dilutions are made using Class
A glassware. Both WBC and RBC are corrected for coincidence.
• Hgb - Hemoglobincyanide spectrophotometric procedure that follows CLSI Standard H15-A7.
This method employs modified Drabkins (Ziljstra) Reagent and is references to NIST-certified
filters and ICSH standards.
• MCV - Packed cell volume measured by a hematocrit procedure that follows CLSI Standard H7-
H8. The PCV is not corrected for trapped plasma. MCV is calculated: PCV/RBC x 10.
• PLT - Phase-contrast microscopy.
• MPV - Reference against latex particles.

CAUTION
Use a Potassium Salt of EDTA for whole blood calibration. Follow the tube
manufacturer’s recommended procedure for the correct volume of anticoagulant.

629743AE 11-5
Quality Assurance
Calibration

CAUTION
If you use vacuum collection tubes, fill them to proper capacity according to the
tube manufacturer’s recommendations.

Calibrating with Whole Blood

1 Select Calibration Setup on the CBC Calibration Screen to display the CBC Calibration Setup
dialog box.

2 Type “3” in the Number of Aspirations text box.

3 Select the Cassette Presentation from the drop-down list.

4 Select Whole Blood from the Calibrator Type drop-down list.

5 Select OK to close the Calibration Setup dialog box.

6 Place the 20 samples in cassettes. Place the cassettes in the input buffer and select OK.

7 When the calibration procedure is complete, the CBC Calibration (Summary) Screen displays.

8 Review the calibration results. The System Manager assesses the calibration status, and
indicates when calibration is recommended in the check boxes below the data.
The background color of the Factor %Diff, %CV, and Difference cells change color when the
presented value is out of the normal range as follows:
• Yellow for Difference indicates that the value is out of range, which means that calibration
is recommended.
• Red only applies to the %CV and indicates that the statistical value is NOT within range and
the system does NOT allow calibration.
When all results are acceptable, the Edit System Recommendations button at the bottom right
hand corner of the screen is enabled. This button allows to modify the calibration
recommended by the system by selecting or deselecting check boxes.

9 Select the Finish button at the bottom of the screen.

10 Verify your calibration with controls.

11-6 629743AE
Quality Assurance
Repeatability (Menu > QA > Repeatability > Repeatability) 11

Repeatability (Menu > QA > Repeatability > Repeatability)

Figure 11.4 Repeatability Screen

Sample Requirements
For Repeatability studies, ensure the patient has normal erythrocyte, leukocyte, and platelet
morphology. You can view a suggested reference range in the Performance Specifications and
Characteristics section of the System Overview chapter.

NOTE Before you can start or restart the Repeatability process, the SPM must be offline.

Repeatability

1 Ensure you have enough normal whole blood from a single donor for a minimum of 10 cycles.

2 Select Repeatability Setup to display the Repeatability Setup dialog box.

629743AE 11-7
Quality Assurance
Repeatability (Menu > QA > Repeatability > Repeatability)

Figure 11.5 Repeatability Setup Dialog Box

Repeatability in Cassette Presentation

1 From the Repeatability Setup dialog box, select a test panel from the Test Panel drop-down list.

NOTE The Repeatability Setup dialog box defaults to Cassette Presentation.

2 Type ‘5’ in the Number of Aspirations text box.

3 Select OK and follow the screen prompts.

CAUTION
Aspiration probe damage can occur if you pierce a specimen tube more than five
times. Do not pierce a specimen tube more than five times.

4 Select OK to start Repeatability test.

11-8 629743AE
Quality Assurance
Repeatability (Menu > QA > Repeatability > Repeatability) 11

5 Separate the well mixed normal specimen into two tubes.

6 Place the tubes into consecutive positions in a cassette and place the cassette in the input
buffer.

7 Select OK on the DxH dialog box to start the cycle.

8 When the cycle has completed review the results on the Repeatability screen. Use the scroll bar
to review results that do not appear in the results panel.

9 Verify that the CV (Coefficient of Variation) does not exceed the established Repeatability
Limits.

NOTE Refer to the Repeatability section of the System Overview chapter for Repeatability performance.

10 Verify the results and if satisfied, select Finish.


NOTE The Finish button is active only when each parameter has two or more valid results.

Repeatability in Single-tube Presentation


Follow the instructions for Cassette Presentation Repeatability, using the Single-tube Presentation
station to present each specimen tube.

Repeatability Run Details


When the Repeatability procedure is complete, the results display on the Repeatability Run Details
screen.

629743AE 11-9
Quality Assurance
Repeatability (Menu > QA > Repeatability > Repeatability)

Figure 11.6 Repeatability Run Details Screen

11-10 629743AE
Quality Assurance
Carryover (Menu > QA > Carryover) 11

Carryover (Menu > QA > Carryover)

NOTE Before you can start or restart the Carryover process, the instrument must be offline.

Figure 11.7 Carryover Screen

NOTE The Blood 1, Blood 2, and Blood 3 row headings on the carryover screen represent 3 aspirations of a
single blood specimen.

1 Select Carryover Setup to display the Carryover Setup dialog box.

629743AE 11-11
Quality Assurance
Carryover (Menu > QA > Carryover)

Figure 11.8 Carryover Setup Dialog Box

2 Select a test panel from the Test Panel drop-down list. Select OK and follow the screen prompts.

3 Select OK to start a Carryover procedure.

4 Place a cassette in the input buffer with one blood tube followed by three diluent tubes and
select OK to start Carryover.

5 When Carryover is complete, review the results on the Carryover screen.

11-12 629743AE
Quality Assurance
Carryover (Menu > QA > Carryover) 11

Figure 11.9 Carryover Screen (Results)

When performing a Carryover procedure, the calculated % Carryover and/or Background for
each parameter is compared to the Carryover and Background limits for acceptability.
The status of each parameter is based on the following criteria:
a. The status of the parameter is Pass for carryover, if
• Diluents 1,2, and 3 are within the Background limits as defined in the Performance
section of the System Overview chapter of this manual for WBC, RBC, HGB, PLT, Diff,
Retic, or NRBC, as applicable to the panel.
• The calculated % Carryover for the WBC, RBC, HGB, and PLT parameters and the total
events for Diluents 1 and 2 for Diff, Retic, and NRBC are within carryover limits.
and
Diluent 3 sample results for WBC, RBC, HGB, PLT, Diff, Retic, and NRBC are within
background limits.

b. The status of the parameter is FAIL for carryover if the criteria described above are not met.

629743AE 11-13
Quality Assurance
Carryover (Menu > QA > Carryover)

Carryover Messages(Menu > QA > Carryover > Messages)


Figure 11.10 Carryover Messages

The Carryover Messages dialog box displays System Status and System Messages. Select Close to
close the dialog box.

11-14 629743AE
Quality Assurance
Exporting Quality Assurance Data 11

Exporting Quality Assurance Data

Select the Export button on the Navigation bar at the bottom of the CBC Calibration, Repeatability
and CBC Calibration screens to export Quality Assurance data.

Figure 11.11 Export QA Data Dialog Box

1 Select the Type of file from the drop-down list.

2 Select a Destination and select Start.

629743AE 11-15
Quality Assurance
Exporting Quality Assurance Data

11-16 629743AE
CHAPTER 12

Cleaning Procedures

When, Why, and How to Perform Each Procedure

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and safety
standards such as the use of barrier protection. This may include, but is not limited to,
protective eyewear, gloves, and suitable laboratory attire.

Table 12.1 Matrix of Frequency for Cleaning Procedures

Procedure Purpose Tools/Supplies Frequency


Clean (Bleach) the To address: • high quality, fragrance- As needed.
Apertures • Failure to recover control values. free, gel-free bleach (5 to
6% solution of sodium
• Decreased cell counts, increased MCV
hypochlorite - available
values or increased voteouts.
chlorine)
• DI (deionized) water
• container for bleach
solution
• container for DI water
Clean the Aspiration Probe To remove buildup. none As needed.
Clean the BSV Externally To remove blood or reagent buildup. • lint-free tissue As needed.
• diluent
Clean the Pneumatic Supply To prevent damage to the Power Supply. • soap As needed.
Module Fan Filter • water
Clean the STM To prevent debris from interrupting the • lint-free tissue As needed when
transportation of specimens. • diluent you discover a
problem, or every
6 months.
Clean the Air Mix To remove buildup. • lint-free tissue As needed.
Temperature Control • diluent
(AMTC) Module
Clean the Vacuum Trap To remove debris that accumulates. water As needed.

629743AE 12-1
Cleaning Procedures
Remove the Transport Shield

Table 12.1 Matrix of Frequency for Cleaning Procedures

Procedure Purpose Tools/Supplies Frequency


Clean the Optical Sensors To remove buildup. • DI water As needed.
• very fine lint-free swab
Clean the Handheld Bar- To remove dirt or dust that has • water As needed,
Code Scanner accumulated. • detergent
• soft cloth or tissue

Remove the Transport Shield

For some of the cleaning procedures you need to remove the transport shield.

1 To remove the transport shield:


a. Grasp the transport shield behind the tabs on both sides.
b. Pull up and out.
c. Silence any alarms.

12-2 629743AE
Cleaning Procedures
Replace the Transport Shield 12

Replace the Transport Shield

1 To replace the transport shield.


a. Locate pins on the shield and the corresponding holes on the front of the SPM.
b. Insert the pins into the holes and push the transport shield into place.

Lift the Front Cover

1 Grasp the sides of the front cover and lift upward. .

1 2

4 5

9743219A

629743AE 12-3
Cleaning Procedures
Lower the Front Cover

Lower the Front Cover

1 Grasp the top of the front cover and push downward.

12-4 629743AE
Cleaning Procedures
Clean (Bleach) the Apertures 12

Clean (Bleach) the Apertures

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

NOTE At the completion of this procedure and prior to sample analysis, you must do a Shutdown and run
Daily Checks.

1 Prepare a 20 mL solution of bleach and DI water. . In a cuvette, mix together:


• 10 mL of high quality, fragrance-free, gel-free bleach (5 to 6% solution of sodium
hypochlorite - available chlorine) and
• 10 mL of DI water.
Label this cuvette “A”.

10 mL 10 mL

A
NaClO DI H2O
(5%)

2 Put 20 mL of DI water in a second cuvette labeled “B”.

20 mL

B
DI H2O

3 At the System Manager, select Menu > Diagnostics > Dx Tools.

629743AE 12-5
Cleaning Procedures
Clean (Bleach) the Apertures

4 Select the Maintenance tab to display the Diagnostic Procedures - Maintenance screen.

5 Select Clean Apertures from the drop-down list.

6 Select the Start button. The system places the SAM in safe mode and drains the baths.

7 Remove the Transport Shield and Lift the Front Cover.

8 Locate the bleach probe.

1 2 3 4 5

12-6 629743AE
Cleaning Procedures
Clean (Bleach) the Apertures 12

9 When prompted, place the bleach probe in a bleach solution (approximately 20 mL of a 1:1
solution of high quality, fragrance-free, gel-free bleach (5 to 6% solution of sodium hypochlorite
- available chlorine) and DI water). The system aspirates the bleach solution and draws it
through the apertures and then drains the baths. .

10 A dialog box displays the Time Elapsed as the aperture bleaching takes place. Select Cancel to
end the bleaching and continue with the procedure.

NOTE A maximum of 15 minutes of aperture bleaching is suggested.

11 When prompted, place the bleach probe in DI water (a cuvette of approximately 20 mL of DI


water). The system aspirates the DI water.

629743AE 12-7
Cleaning Procedures
Clean (Bleach) the Apertures

12 Follow the directions on the screen.

13 Lower the Front Cover and Replace the Transport Shield.

14 Run Shutdown. Refer to the Daily Shutdown section in the Shutdown chapter for instructions.
NOTE Do not select the Perform Startup (Daily Checks) after Shutdown check box on the Manual
Shutdown dialog box.

15 Select the Cancel button on the Navigation bar at the bottom of the screen when you see the
timing bar at the lower right-hand side of the screen start to count down.

16 Run Daily Checks. Refer to Run Daily Checks in the Daily Checks chapter.

12-8 629743AE
Cleaning Procedures
Clean the Aspiration Probe 12

Clean the Aspiration Probe

NOTE Beckman Coulter recommends that you do the Dispense Diluent procedure after cleaning the
aspiration probe to verify the integrity of the aspiration path.

1 Select Menu > Diagnostics > Dx Tools > Maintenance.

2 In the Fluidic option box, select the Select option button and then select Clean Aspiration Probe
from the drop-down list.

3 Select the Start button. The system:


• Moves the SAM to a position between the cassette mixer and the AMTC module.
• Lowers the probe assembly and extends the aspiration probe, exposing it behind the
transport shield.
• Flushes the outside of the aspiration probe with diluent as the probe retracts.

4 Press (F10) Access System Monitor, if necessary, to view the Probe Waste Vacuum sensor’s state
on the System Monitor screen.

5 Do the Dispense Diluent procedure. Refer to the Dispense Diluent Procedure (Menu >
Diagnostics > Dx Tools > Maintenance) section in the Troubleshooting chapter for instructions.

6 When the procedure is complete, select Finish.

629743AE 12-9
Cleaning Procedures
Clean the BSV Externally

Clean the BSV Externally

WARNING
Risk of personal contamination. The BSV can contain residual biohazardous
material. Avoid skin contact. Clean up spills immediately in accordance with your
local regulations and acceptable laboratory procedures.

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

NOTE Clean the outside of the BSV if there is an excessive buildup of dried diluent on the outside. Note that
crystallized Beckman Coulter cleaning agent on the outside of the BSV is normal.

1 Turn off the SPM.

2 Remove the Transport Shield.

3 Lift the Front Cover.

12-10 629743AE
Cleaning Procedures
Clean the BSV Externally 12

4 Locate the BSV.

DxH 800 Hematolgy Analyzer

5 Dampen a piece of lint-free tissue with DI water and wipe down the outside of the BSV.

629743AE 12-11
Cleaning Procedures
Clean the BSV Externally

6 Wipe out the drip tray under the BSV with a lint-free tissue dampened with DI water.

7 Lower the Front Cover.

8 Replace the Transport Shield.

9 Turn on the SPM.

12-12 629743AE
Cleaning Procedures
Clean the Pneumatic Supply Module Fan Filter 12

Clean the Pneumatic Supply Module Fan Filter

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

1 Turn off the SPM.

2 Unscrew the power/communications cable from the PSM.

629743AE 12-13
Cleaning Procedures
Clean the Pneumatic Supply Module Fan Filter

3 Locate the filter on the top of the PSM.

POW
ER ON
PUMP
RUNNING PNEUMA
PULL TIC
TO FAUL
T
ADJU
ST

4 Using a flathead screwdriver or your hand, loosen the thumbscrews that secure the filter
retaining plate and remove the filter from the PSM.

5 Wash the filter in soap and water and rinse and dry completely. If you find a filter that is torn
or shredded, discard it and replace it with a new one. Order replacement filters from your
Beckman Coulter Representative.

12-14 629743AE
Cleaning Procedures
Clean the Pneumatic Supply Module Fan Filter 12

6 Return the clean air filter and retaining plate to their original location and fasten the
thumbscrews to secure the filter.

7 Connect the power/communications cable connector with the power/communications port on


the PSM.
a. Line up the holes of the connector with the pins in the port.

b. Push the connector into the port so that the pins in the port are inserted into the connector.

629743AE 12-15
Cleaning Procedures
Clean the STM

c. Fasten the connector by turning the connector clockwise.

8 Turn on the SPM.

Clean the STM

WARNING
Risk of personal contamination. The STM can contain residual biohazardous
material. Avoid skin contact. Clean up spills immediately in accordance with your
local regulations and acceptable laboratory procedures.

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

12-16 629743AE
Cleaning Procedures
Clean the STM 12

1 Turn off the SPM.

2 Remove any cassettes in the input or output buffer.

1 2

4 5
000
41

00041
00042
00043
00044 A
00045

3 Remove the Transport Shield.

629743AE 12-17
Cleaning Procedures
Clean the STM

4 Grasp the front of the STM on both sides, lift and pull toward you as if opening a drawer.

5 Examine the drip trays behind the mixer and behind the pending buffer.

6 Use a lint-free tissue dampened with DI water to clean the inside of the STM and drip trays,
wiping up any spills or buildup.

12-18 629743AE
Cleaning Procedures
Clean the STM 12

CAUTION
Using bleach to clean the STM drip trays can damage the surface of the drip trays.

CAUTION
Discard waste in a biohazard waste container.

7 Dry the inside of the STM by wiping with a dry lint-free tissue.

8 Grasp the front of the STM on both sides, lift and push to replace the STM.

9 Replace the Transport Shield.

629743AE 12-19
Cleaning Procedures
Clean the STM

10 Turn on the SPM.

12-20 629743AE
Cleaning Procedures
Clean the Air Mix Temperature Control (AMTC) Module 12

Clean the Air Mix Temperature Control (AMTC) Module

WARNING
Risk of personal contamination. The AMTC can contain residual biohazardous
material. Avoid skin contact. Clean up spills immediately in accordance with your
local regulations and acceptable laboratory procedures.

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

1 Turn off the SPM.

2 Remove the transport shield.

3 Dampen a lint-free applicator stick with DI water.

NOTE You can use a fabric tipped applicator to clean the top of the AMTC.

629743AE 12-21
Cleaning Procedures
Clean the Air Mix Temperature Control (AMTC) Module

4 Clean the ports of the AMTC.


a. Gently pull back the black protective flap in front of the AMTC with one hand.
b. With the other hand, carefully use the tip of the applicator stick to wipe debris away from
the ports on the AMTC.
NOTE It is important to avoid getting debris in the holes at the top of the AMTC during this procedure.

5 Replace the transport shield.

6 Turn on the SPM.

12-22 629743AE
Cleaning Procedures
Clean the Vacuum Trap 12

Clean the Vacuum Trap

WARNING
Risk of personal contamination. The vacuum trap can contain residual
biohazardous material. Avoid skin contact. Clean up spills immediately in
accordance with your local regulations and acceptable laboratory procedures.

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

1 Turn off the SPM.

2 Locate the vacuum trap.

POW
ER ON
PUMP
RUNNING PNEUMA
PULL TIC
TO FAUL
T
ADJU
ST

629743AE 12-23
Cleaning Procedures
Clean the Vacuum Trap

3 Holding the top of the vacuum trap with one hand, use the other hand to unscrew the vacuum
trap jar.

4 Empty the vacuum trap jar according to your local environmental regulations and your
laboratory’s procedures.

5 Rinse the vacuum trap jar with water, and then shake out the excess water.

6 Use a lint-free tissue to dry the vacuum trap jar.

12-24 629743AE
Cleaning Procedures
Clean the Vacuum Trap 12

7 Dampen a lint-free tissue with DI water and wipe down the black center post inside the vacuum
trap assembly. Spin the center post to wipe down the entire surface.

8 Replace the vacuum trap jar.


a. Ensure that the black center post is not stuck in the up position.

b. Carefully align the threads on the vacuum trap jar with the threads on the vacuum trap
assembly and screw the vacuum trap jar into place.

9 Wipe up any spills.

629743AE 12-25
Cleaning Procedures
Clean the Optical Sensors

10 Turn on the SPM.

Clean the Optical Sensors

WARNING
Risk of personal contamination. The optical sensors can contain residual
biohazardous material. Avoid skin contact. Clean up spills immediately in
accordance with your local regulations and acceptable laboratory procedures.

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

1 Turn off the SPM.

2 Remove the transport shield and lift the front cover.

12-26 629743AE
Cleaning Procedures
Clean the Cassettes 12

3 Locate the optical sensor. Three are located at the input buffer and two at the output buffer.
Refer to Figure 1.6, STM Top Level View.

4 Dampen a very fine lint-free swab with DI water.

5 Swab the Optical sensor to remove buildup.

6 Lower the front cover and replace the transport shield.

7 Turn on the SPM.

Clean the Cassettes

WARNING
Risk of personal contamination. The cassettes can contain residual biohazardous
material. Avoid skin contact. Clean up spills immediately in accordance with your
local regulations and acceptable laboratory procedures.

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

Wash the cassettes as needed in warm soapy water and rinse thoroughly. Do not use an abrasive.
Keep the cassettes free of dried blood, bleach, or diluent. Be careful not to scratch or deface the bar-
code labels. Dirt, smears, pencil lead, and grease can affect bar-code label reading.

629743AE 12-27
Cleaning Procedures
Clean the Handheld Bar-Code Scanner

Clean the Handheld Bar-Code Scanner

CAUTION
To avoid damaging the handheld scanner, do not submerge the scanner in water
and do not use abrasive cloth or tissue on the window. Never use solvents (for
example, acetone, benzene, ether, or phenol-based agents) on the housing or
window. Solvents can damage the finish or the window.

If the scan window is visibly dirty, or if the scanner is not scanning well, clean the scan window with
a soft cloth or lens tissue dampened with water (or a mild detergent-water solution). If a detergent
solution is used, rinse with a clean lens tissue dampened with water only.

The scanner housing can be cleaned the same way.

12-28 629743AE
CHAPTER 13

Replacement / Adjustment Procedures

When, Why, and How to Perform Each Procedure

WARNING
Use caution as AC Voltages may be present. Diagnostics procedures (run from
Menu> Diagnostics> Dx Tools) automatically place the SPM in safe mode;
however, for all other replacement procedures, you must turn off the power switch
in front of the SPM.

CAUTION
Do not attempt to perform any procedure before carefully reading all instructions.
Always follow product labeling and manufacturer’s recommendations. If in doubt
as to how to proceed in any situation, contact your Beckman Coulter
Representative.

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

629743AE 13-1
Replacement / Adjustment Procedures
Manage Supplies

Table 13.1 Matrix of Frequency for Replacement Procedures

Procedure Purpose Tools/Supplies Frequency


Replace the Aspiration Probe To replace a defective • new aspiration probe As needed.
aspiration probe. • pliers
Replace the Front Blood Detector To replace a defective • new Front Blood As needed.
Front Blood Detector. Detector
• screw driver
• needle-nose pliers
Replace the Count Vacuum To replace a defective • New Count Vacuum As needed.
Regulator count vacuum regulator. Regulator
• Flat-head screw
driver
Replace the Pneumatic Supply To replace a defective • New Pneumatic As needed.
Module (PSM) Pneumatic Supply Supply Module
Module. • Phillips-head
screwdriver
• 1/2 nut driver (in tool
box in Accessory kit)
Replace Reagent Containers Reagent container is New reagent containers. As needed to replace
empty. empty reagent
containers. The Supplies
alert status icon (see
Alert Status Icons)
displays the status of the
supplies.
Replace the Waste Container Waste container is full. New, empty waste As needed to replace full
containers. waste containers.
Replace the Hand-held Bar-Code To replace a defective none As needed.
Scanner Hand-held Bar Code
Scanner.

Manage Supplies

The system monitors the supplies status and provides you with a visual indication of their states
through the Supplies alert indicator icon. While there is valid reagent usage remaining for all the
supplies, the Supplies icon background is beige or neutral. A yellow background indicates a warning
condition and a red background indicates an error condition. You can return the color to neutral by
replacing the supplies that are low, depleted, or expired.

13-2 629743AE
Replacement / Adjustment Procedures
Replace the Aspiration Probe 13

Replace the Aspiration Probe

WARNING
Risk of injury and false hardware errors. To avoid injury and false hardware errors,
do not remove the transport shield or lift the front cover until otherwise
instructed.

WARNING
Risk of personal contamination. The aspiration probe and the associated tubing
contain residual biohazardous material. Avoid skin contact. Clean up spills
immediately in accordance with your local regulations and acceptable laboratory
procedures.

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

Removing and Replacing the Aspiration Probe

1 Select Menu > Diagnostics > Dx Tools.

2 Select the Maintenance tab.

3 Select Change Aspiration Probe from the Maintenance drop-down list.

4 Select the Start button.

5 A pop-up window displays the following message:


System placing aspiration probe in safe mode. Please wait.

6 When the aspiration probe is in safe mode, Remove the Transport Shield and Lift the Front
Cover.

629743AE 13-3
Replacement / Adjustment Procedures
Replace the Aspiration Probe

7 Locate the aspiration probe.

1 2 3 4 5

8 Remove the shield.

13-4 629743AE
Replacement / Adjustment Procedures
Replace the Aspiration Probe 13

9 Disconnect the tubing at the top of the probe.

NOTE Use the tips of the pliers to push the tubing up. Do not crimp the tubing.

10 Completely unscrew the knurled nut securing the probe.

629743AE 13-5
Replacement / Adjustment Procedures
Replace the Aspiration Probe

11 Lift the aspiration probe up and out.


NOTE The tube must be clear of the probe wipe before lifting out. Use caution so that you don’t bend
the probe during replacement.

Installing the New Aspiration Probe

1 Pick up the new aspiration probe.

13-6 629743AE
Replacement / Adjustment Procedures
Replace the Aspiration Probe 13

2 Orient the probe so that the tab on the top corresponds to the notch in the probe holder.

3 Insert the probe tip into the probe wipe then fit the top section into the holder.

629743AE 13-7
Replacement / Adjustment Procedures
Replace the Aspiration Probe

4 Tighten the knurled nut.

5 Reattach tubing to the top of the probe.

NOTE Use care so that you don’t crimp the tubing with the pliers.

13-8 629743AE
Replacement / Adjustment Procedures
Replace the Aspiration Probe 13

6 Replace the SAM shield.

7 Lower the Front Cover and Replace the Transport Shield.

8 Perform the Dispense Diluent Procedure (Menu > Diagnostics > Dx Tools > Maintenance).

9 Perform the Verify Aspiration Probe Alignment (Menu > Diagnostics > Dx Tools > Maintenance).

10 Select Finish.

629743AE 13-9
Replacement / Adjustment Procedures
Replace the Front Blood Detector

Replace the Front Blood Detector

WARNING
Risk of personal contamination. The front blood detector and the associated
tubing can contain residual biohazardous material. Avoid skin contact. Clean up
spills immediately in accordance with your local regulations and acceptable
laboratory procedures.

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

NOTE The front blood detector is shipped with the sample line threaded through it; therefore, it is not
necessary for you to remove or insert the sample line from the blood detector for this procedure.

1 Turn off the SPM.

2 Remove the Transport Shield.

3 Lift the Front Cover.

13-10 629743AE
Replacement / Adjustment Procedures
Replace the Front Blood Detector 13

4 Locate the blood detector (physically attached by two screws to the Probe Vertical Drive
assembly).

5 Remove the SAM shield.


a. Use a Phillips screw driver to remove the two screws at the front of the shield.
b. Remove the shield.

629743AE 13-11
Replacement / Adjustment Procedures
Replace the Front Blood Detector

6 Remove and retain the two screws securing the blood detector at the front of the Probe Vertical
Drive assembly.

7 Disconnect the sample line tubing at the top of the aspiration probe.

NOTE Use the tip of the pliers to push the tubing up. Use caution so that you don’t crimp the tubing.

13-12 629743AE
Replacement / Adjustment Procedures
Replace the Front Blood Detector 13

8 Disconnect the sample line from the BSV and pull the tube through and out of the coiled tubing
and down and out of the holders. Place the black cone aside for use with the new blood detector.

9 Release the electrical connection wires from the clip.

629743AE 13-13
Replacement / Adjustment Procedures
Replace the Front Blood Detector

10 Disconnect the electrical connection at the front of the vertical probe drive

11 Remove and discard the old blood detector assembly.


CAUTION
Do not discard the black cone. You need it for the new blood detector.

13-14 629743AE
Replacement / Adjustment Procedures
Replace the Front Blood Detector 13

12 Install the new blood detector assembly using the black cone and 2 screws retained from the
old blood detector.

9743414A

a. Attach the new blood detector assembly to the Probe Vertical Drive assembly.

629743AE 13-15
Replacement / Adjustment Procedures
Replace the Front Blood Detector

b. Thread the tube through the holders on the side of the Probe Vertical Drive assembly.

c. Thread the tube through the coiled tubing, then thread the tubing through the cone with
the narrow end toward the BSV. Attach tubing to the port on the BSV and slide the cone up
against the BSV.

13-16 629743AE
Replacement / Adjustment Procedures
Replace the Front Blood Detector 13

d. Connect the tube to the aspiration probe.

e. Connect electrical connector to the board and secure wires in clips.

629743AE 13-17
Replacement / Adjustment Procedures
Replace the Front Blood Detector

13 Replace the SAM shield over the Probe Vertical Drive assembly.

14 Lower the Front Cover.

15 Replace the Transport Shield.

16 Turn on the SPM.

17 Run the Verify Blood Detectors Procedure (Menu > Diagnostics > Dx Tools > Maintenance).

13-18 629743AE
Replacement / Adjustment Procedures
Replace the Count Vacuum Regulator 13

Replace the Count Vacuum Regulator

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

Remove the Old Count Vacuum Regulator

1 Turn off the SPM.

2 Remove the Transport Shield.

3 Lift the Front Cover.

629743AE 13-19
Replacement / Adjustment Procedures
Replace the Count Vacuum Regulator

4 Move the SAM to the right to reveal the Count Vacuum Regulator.

5 Disconnect the yellow quick disconnect and the black quick disconnect.

13-20 629743AE
Replacement / Adjustment Procedures
Replace the Count Vacuum Regulator 13

6 Using a flat-head screw driver, loosen the screw.

7 Remove the old Count Vacuum Regulator and discard.

629743AE 13-21
Replacement / Adjustment Procedures
Replace the Count Vacuum Regulator

Installing the New Count Vacuum Regulator

1 Place regulator on the instrument by lining up the thumbscrew and tab on the bracket with the
corresponding holes on the instrument.

2 Using the flat-head screw driver, tighten the thumbscrew.

13-22 629743AE
Replacement / Adjustment Procedures
Replace the Count Vacuum Regulator 13

3 Connect the yellow and black quick disconnects.

NOTE Be careful not to leave tubing twisted or crimped.

4 Lower the Front Cover.

5 Replace the Transport Shield.

6 Turn on the SPM.

7 Run the Check Count Vacuum Procedure.

NOTE Refer to Check Count Vacuum Procedure (Menu > Diagnostics > Dx Tools > Maintenance) in the
Troubleshooting chapter for instructions.

629743AE 13-23
Replacement / Adjustment Procedures
Replace the Count Vacuum Regulator

8 Press (F10) Access System Monitor and select the Volt/Temp button. In the CBC panel of the
System Monitor screen, verify that Count Vac reads 6.0 +/- 0.1.
a. If the vacuum needs to be adjusted, turn the Count Regulator knob clockwise to increase
the vacuum or counter-clockwise to decrease the vacuum.
b. After you have verified that the vacuum is 6, select the Stop button on the Diagnostic
Procedures - Maintenance button to stop the Check Pneumatic Supply procedure.

13-24 629743AE
Replacement / Adjustment Procedures
Replace the Pneumatic Supply Module (PSM) 13

Replace the Pneumatic Supply Module (PSM)

Unpack the New PSM

1 Unpack the PSM, remove the plastic sheeting,

2 Using the handles on the PSM, lift it out of the box.

POWE
R ON
PUMP
RUNN PNEU
PULL ING MATIC
TO FAUL
T
ADJUS
T

3 Lay the PSM on it’s side.

629743AE 13-25
Replacement / Adjustment Procedures
Replace the Pneumatic Supply Module (PSM)

4 On the bottom of the PSM, use a Phillips screw driver to remove the four Phillips-head screws
inside the four socket-head screws, then use the nut driver from your accessory kit to remove
the four socket head screws.

5 Set the PSM upright and locate it in the desired location.

NOTE If you are using a Floor Stand, you must connect the new PSM before you place it in the floor
stand. Refer to Remove and Replace the PSM in this chapter for additional instructions.

13-26 629743AE
Replacement / Adjustment Procedures
Replace the Pneumatic Supply Module (PSM) 13

Remove and Replace the PSM

WARNING
Risk of personal contamination. The PSM and the associated tubing can contain
residual biohazardous material. Avoid skin contact. Clean up spills immediately in
accordance with your local regulations and acceptable laboratory procedures.

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

1 Turn off the SPM.

2 Locate the Pneumatic Supply Module.

NOTE If your Pneumatic Supply Module is in a floor stand, refer to the Optional Floor Stand section of
the System Overview for instructions on locating the Pneumatic Supply Module.

629743AE 13-27
Replacement / Adjustment Procedures
Replace the Pneumatic Supply Module (PSM)

3 Unscrew the power/communications cable from the compressor.

NOTE If you are using a Floor Stand, remove the PSM from the drawer before disconnecting.

4 Disconnect vacuum and pressure lines.


a. Push the vacuum connector rubber sleeve and pull vacuum tube from the connector.
b. Press down on the Pressure connector to remove the connector and pressure line.

5 Replace the old compressor with the new compressor.


a. Lift the compressor by using the handles on the front and rear of the PSM.

13-28 629743AE
Replacement / Adjustment Procedures
Replace the Pneumatic Supply Module (PSM) 13

CAUTION
Follow your laboratory’s guidelines for lifting to avoid injury.

POW
ER ON
PUMP
RUNNIN PNEUMA
PULL G TIC
TO FAULT
ADJU
ST

6 Connect the vacuum and pressure lines.

NOTE If you are using a Floor Stand, connect everything before placing the new PSM in the floor stand
drawer.

a. Insert the vacuum tube into the Vacuum connector.

629743AE 13-29
Replacement / Adjustment Procedures
Replace the Pneumatic Supply Module (PSM)

b. Push the Pressure connector into the connecting port until it snaps into place.

7 Connect the power/communications cable connector with the power/communications port on


the PSM.
a. Line up the holes of the connector with the pins in the port.

b. Push the connector into the port so that the pins in the port are inserted into the
connector.

13-30 629743AE
Replacement / Adjustment Procedures
Replace the Pneumatic Supply Module (PSM) 13

c. Fasten the connector by turning the connector clockwise.

NOTE If you are using a Floor Stand, after connection is complete, the PSM must be centered in the
drawer ensuring that the rubber mounts in the drawer align with the holes under the pneumatic
module. Avoid touching the inner sides of the drawer (to avoid vibration transfer through the floor
stand to the SPM).

629743AE 13-31
Replacement / Adjustment Procedures
Replace the Pneumatic Supply Module (PSM)

8 Turn on the SPM.

9 Adjust the Pneumatic Supply Regulator to 25psi.

NOTE Wait until the system has completely powered on before doing the adjustment.

Adjust the Pneumatic Supply Regulator

1 Turn the knob on the Pneumatic Supply Module to adjust the Pneumatic Supply Regulator to
25 psi.

2 Press (F10) Access System Monitor and select the Volt/Temp button to display the Raw Pressure
reading.

13-32 629743AE
Replacement / Adjustment Procedures
Replace Reagent Containers 13

Replace Reagent Containers

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

1 Locate the old Reagent container.

NOTE If you are using a floor stand, refer to the Optional Floor Stand section of the System Overview
chapter for instructions on locating reagents in the Floor Stand.

2 Place the new reagent box near the old container.

NOTE If you are using a floor stand, lift out the old container and place the new container on the drawer.
Make sure that you position the containers correctly in the floor stand so that you do not crimp the
tubes when they are inserted.

3 Remove any cardboard cutouts from the new container.

629743AE 13-33
Replacement / Adjustment Procedures
Replace Reagent Containers

4 Remove the cap and seal from the new reagent container. Be sure to completely remove the foil
seal and lift the neck of the container.

5 Remove the plastic collar that secures the pickup tube assembly.

6 Unscrew the pickup tube assembly of the old container and lift it straight up and out.

7 Inspect the pickup tube for damage, and replace it if necessary.

13-34 629743AE
Replacement / Adjustment Procedures
Replace Reagent Containers 13

8 Carefully insert the pickup tube assembly straight into the new container and tighten the cap.

NOTE The pick up tube has several tubes that bend when the assembly is being placed into the
new container that can make it difficult to insert. Use a slight twisting motion if you
experience difficulty.

IMPORTANT Check the tube for visual leaks or places where the tube is crimped or pinched. If there are
leaks you will need to replace the tube. If there are crimped or pinched areas, the container may need to
be repositioned.

9 Insert the plastic collar that secures the pickup tubes.

10 Scan the new DxH container’s information on the Setup DxH Supplies dialog box or manually
enter information on the Setup Other Supply dialog box. Refer to Set Up Supplies (Menu >
Supplies > Setup) in the Setup chapter of this manual.

629743AE 13-35
Replacement / Adjustment Procedures
Replace the Waste Container

11 If you are using a Floor Stand, ensure that you do not tangle the tubing for the various reagents
in the upper left drawer of the floor stand. This may make it difficult for reagent replacement
in the future.

Replace the Waste Container

WARNING
Beckman Coulter, Inc. urges its customers to comply with all national health and
safety standards such as the use of barrier protection. This may include, but is not
limited to, protective eyewear, gloves, and suitable laboratory attire.

WARNING
Possible biohazardous condition. The contents of the old waste container and its
associated tubing can include residual biological material and must be handled
with care. Check the tubing connection and container location periodically. Avoid
skin contact and clean up spills immediately. Dispose of the contents of the waste
container in accordance with your local regulations and acceptable laboratory
procedures.

CAUTION
Waste containers (if used) must be located in a safe place and tubing connection
integrity must be verified periodically. Operator must not replace the waste
container while the SPM is cycling.

CAUTION
If the waste line is connected to a drain instead of a waste container, the waste
line must be secured into the drain so that the tube cannot accidentally come out
of the drain. If using this method of waste removal, Beckman Coulter recommends
that you schedule routine maintenance of the laboratory drain pipes.

1 Locate the waste containers.

NOTE If your waste containers are located in a Floor Stand, refer to theOptional Floor Stand chapter in
the System Overview chapter for instructions on locating the waste containers.

13-36 629743AE
Replacement / Adjustment Procedures
Replace the Waste Container 13

2 Label and uncap an empty waste container and place it near the full one. Save the cap to put
onto the full waste container.

NOTE If you are using a Floor Stand, place the empty waste container into the drawer first, and the full
container on the floor; then, remove the tubing from the full waste container.

3 Ensure that the SPM is not cycling.

4 Slide the collar off the full waste container.

629743AE 13-37
Replacement / Adjustment Procedures
Replace the Waste Container

5 Unscrew the waste tube/level sense assembly cap and lift the assembly straight up and out.

6 Insert the assembly into the empty waste container and screw the cap tightly in place. Cap the
full waste container before moving it.

7 Slide the collar into place.

13-38 629743AE
Replacement / Adjustment Procedures
Replace the Hand-held Bar-Code Scanner 13

8 Verify that the old container is clearly labeled, add 250 mL of 5% bleach to the 10L old container,
then discard according to your laboratory’s standards for biohazardous material.

Replace the Hand-held Bar-Code Scanner

1 Disconnect the hand-held bar-code scanner from the USB port at the front of the System
Manager CPU.

2 Install the new scanner by connecting the cable to the USB port at the front of the System
Manager CPU.

629743AE 13-39
Replacement / Adjustment Procedures
Replace the Hand-held Bar-Code Scanner

13-40 629743AE
APPENDIX A

Special Equipment

Bar-Code Label Specifications

The supported specimen bar-code symbologies are Code 128, Codabar, NW7, Code 39, and Interleave
2 of 5. The number of characters that can be read by the bar-code reader is limited to 22 characters
or to that which can be printed in the viewable height, whichever is less.

Approximately the bottom 10 mm and the top 10 mm of all tubes is not viewable by the bar-code
reader. This is due to the curvature at the bottom of a rounded tube as well as to the cassette
barcode window. The top 10mm dimension is measured from the bottom edge of the cap.

Table A.1 Printing Parameter’s Specifications

10 uM 3:1 Ratio Recommended

Number of Characters by Code Type


Minimum Tube
Length Required Code 128 Code 3 of 9 I 2 of 5 Codabar

55 mm 9 4 12 8
60 mm 11 5 14 9
65 mm 12 6 16 11
70 mm 14 8 18 12
75 mm 16 9 20 14
80 mm 19 10 22 16
85 mm 21 11 — 18
90 mm 22 12 — 19
95 mm — 13 — 20
100 mm — 14 — 22

629743AE A-1
Special Equipment
Tube Specifications

Tube Specifications

Tube specifications can be found at www.beckmancoulter.com.

NOTE Beckman Coulter does not recommend the use of one tube in preference to another nor guarantee
the acceptability of the sample tube to produce quality results. If you need information on a tube not listed
here, contact your Beckman Coulter Representative.

Managing Supplies

For information on replacement parts or consumable products, contact your Beckman Coulter
Representative.

A-2 629743AE
APPENDIX B

Operator Access

Operator Roles

Operators can be assigned Level I, II, or III on the DxH 800 System, with Level III being Lab
Administrator access.

Operator Access

The following tables list the operator’s access by Operator Role. These lists are not all inclusive.

629743AE B-1
Operator Access
Operator Access

Table B.1 Access to Patient Related Functions

Privileges to Level I Level lI Level III

Create Patient Demographics √ √ √

Modify Patient Demographics √ √ √

Delete Patient Demographics X √ √

Rectify Patient Demographics X √ √

Review Patient Demographics √ √ √

Replace Patient Demographics X √ √

Edit Patient Results X √ √

Review Patient Results √ √ √

Release Patient Results X √ √

Delete Patient Results X √ √

Clear Exceptions √ √ √

Request Rerun/Reflex Tests X √ √

Add Comment √ √ √

Modify Comment √ √ √

Delete Comment X √ √

Modify Specimen Information √ √ √

Generate Patient Reports √ √ √

Export Patient Results X √ √

Enable/Configure Studiesa √ √ √

Configure Auto Report Criteria X √ √

Configure Batching X √ √

Configure Advanced Sort/Filter Criteria in Worklist X √ √

Define, Modify and Delete User Defined Comments √ √ √


Patient Functions not identified above X X √
a. If studies mode is enabled, the user also has privileges to configure the following settings for the way that studies
mode will operate: Auto print for studies specimens, Auto transmit for studies specimens, Number of aspiration per
tube for default test order.

B-2 629743AE
Operator Access
Operator Access B

Table B.2 Access to Quality Control Related Functions

Privileges to Level I Level II Level III


Configure Controls X √ √
Run Control Samples X √ √
View QC Results √ √ √
Delete Results X X √
Delete Controls X X √
Export Control Results X √ √
Add Control Comment X √ √
Modify Control Comment X √ √
Delete Control Comment X √ √
Generate Control Reports √ √ √
Configure XB on/off √ √
Configure Extended QC X √ √
Configure XM X √ √
View XB/XM Results √ √ √
Delete XB/XM Results X X √
Add XB/XM Comment X √ √
Modify XB/XM Comment X √ √
Delete XB/XM Comment X √ √
Export XB/XM Results X √ √
Generate XB/XM Reports √ √ √

629743AE B-3
Operator Access
Operator Access

Table B.3 Access to Configuration

Privileges to Level I Level II Level III


Configure Primary Identification X √ √
Adjust Volume of Audible Alarm X √ √
Enable/Disable Audible Alarm X X √
All other system setup items X X √
Configure Operators and Roles X X √
Edit Operators and Roles X X √
Reset Password X X √
Change Password √ √ √
Save/Restore/Print System Configuration X √ √
View Bar code Settings X √ √
Perform Bar code Discovery Procedure √ √ √
Configure All Other Bar Code Functions X X √
Logon/Logoff √ √ √
Configure Tests X X √
Configure Specimen Processing (i.e. Auto Stop) X X √
Configure Printing at Workstation X X √
Enable/Disable All LIS Automatic Transmissions √ √ √
All Other LIS Configurations X X √
Temporarily Disable Analysis X √ √

Table B.4 Access to Test Order Management

Privileges to Level I Level II Level III


Create Test Orders √ √ √
Submit Test Orders √ √ √
Delete Test Orders √a √b √c
Modify Test Orders √ √ √
Set Number of Aspirations if Studies is Enabled √ √ √
All Other Default Test Order Configuration √ √ √
All Other Test Configuration X X √
a. Deletion only of active test orders where all tests are pending for the entire test order.
b. Deletion of any pending or completed test orders, except when a test order is in progress.
c. Deletion of any pending or completed test orders, except when a test order is in progress.

B-4 629743AE
Operator Access
Operator Access B

Table B.5 Access to Calibration

Privileges to Level I Level II Level III


View CBC Calibration √ √ √
All Other CBC Calibration Functions X √ √
Manually Edit CBC Calibration Factors X √ √
Perform Non-Routine Calibration (Perform Function) X √ √
View Repeatability √ √ √
All Other Repeatability Functions X √ √
Perform Carryover X √ √
Export Calibration-Related Results X √ √
Generate Calibration-Related Reports X √ √

Table B.6 Access to Report Generation

Privileges to Level I Level II Level III


Dispatch Report (print, transmit) √ √ √
Configure Reports X X √
Export Data X √ √

Table B.7 Access to Maintenance/Diagnostics

Privileges to Level I Level II Level III


Customer Available Test/Adjust Procedure X √ √
Service Available Test/Adjust Procedure X √ √
Perform Customer Maintenance Cycles √ √ √
Perform Service Maintenance Cycles X √ √
Register Device - Configure Desktop Sharing X √ √
Register Device - Allow Desktop Sharing √ √ √
Upload Information to RMS X √ √
Configure Automatic Maintenance Cycles X √ √

Table B.8 Access to Consumable Management

Privileges To Level I Level II Level III


Viewing Consumable Status √ √ √
Set Diluent Configuration (1 or 2 diluents) X X √
All Other Consumable Functions √ √ √

629743AE B-5
Operator Access
Operator Access

Table B.9 Access to Workload

Privileges to Level I Level II Level III


View Workload Data √ √ √
Export Workload Data X X √
Upload Workload Data X X √
Generate Workload Report √ √ √

Table B.10 Access to Log Management

Privileges to Level I Level II Level III


Consumables Data Summary: X X X
- View, Print, Sort, Filter, Export Logs √ √ √
- Access Detailed Data √ √ √
- Add Log Comments √ √ √
- View, Print, Sort, Filter, Export Logs √ √ √
- Delete Logs X X √
- Access Detailed Data √ √ √
- Add Log Comments √ √ √
Service: X X X
- View, Print, Sort, Filter, Export Logs √ √ √
Maintenance: X X X
- View, Print, Sort, Filter, Export Logs √ √ √
- Add Log Entries √ √ √
- Add Log Comments √ √ √
All Event Logs: X X X
- View, Print, Sort, Filter, Export Logs √ √ √
- Delete Logs X √ √
- Access Detailed Data X √ √
- Add Log Comments √ √ √
Audit Log X X X
- View, Print, Sort, Filter, Export Logs √ √ √
- Access Detailed Data √ √ √
- Add Log Comments √ √ √
Manage Host Log (within Diagnostics) X X X
- Enable, Disable, and Delete X X √
- All other functions √ √ √

B-6 629743AE
Operator Access
Operator Access B

Table B.11 Access to Manage/Monitor System

Privileges to Level I Level II Level III


Backup/Restore System: X X X
- Manual Backup X √ √
- Manual Restore X X √
Change Module State (offline, online) √ √ √
View Status √ √ √
View Component Configuration Information √ √ √
Get Help √ √ √
Error Management √ √ √

Table B.12 Access to Installation/Upgrade Category

Privileges to Level I Level II Level III


Install Software X √ √
Upgrade Software X √ √

Table B.13 Operator Access to Operating System (OS)

Privileges to Level I Level II Level III


Basic OS functions (Wordpad) to create, view √ √ √
and update text files
Basic OS functions (Paint) to capture images √ √ √
Exit System Manager Application to OS X √ √
Access Printer Add/Maintenance* X √ √
Access System Recover functions* X √ √

* To access these functions, it is necessary to exit from the System Manager application to the OS
desktop. When the System Manager application is exited, the OS desktop will be configured to allow
access to the Printer Add/Maintenance and system Recover functions, but not other functions.

629743AE B-7
Operator Access
Operator Access

B-8 629743AE
APPENDIX C

Logs

HIstory Logs (Menu > Logs)

Select the Event Log icon at the top of any screen to display the History Logs screen.
The Log Type drop-down list on the History Logs screen allows you to view logs by type.

629743AE C-1
Logs
HIstory Logs (Menu > Logs)

Event Logs (Menu > Logs > Event Logs)


Figure C.1 Event Logs -System Status Tab

The History Logs - Event Logs screen displays seven unique tabbed views; however, the options
available on the Local Navigation bar at the bottom of the Event Logs screen are the same for each
tabbed view.

Options on the Event Logs Screen

Find Logs

Select the Find button on the Event Logs screen to display the Find dialog box.

Figure C.2 Find Event Dialog Box

C-2 629743AE
Logs
HIstory Logs (Menu > Logs) C

Log Details

Select the Details button on the History Logs - Event Logs screen to display the Event Details dialog
box.

Figure C.3 Event Details Dialog Box

Add Comments to Logs


Select the Comments button on the Event Logs screen to add comments to an event.

Figure C.4 Comments Dialog Box

1 Type in the Enter Comment text box.

629743AE C-3
Logs
HIstory Logs (Menu > Logs)

2 To Log Comment/Event in Maintenance Log select the check box.

3 Select OK.

Filter Logs
Select the Filter button on the History Logs - Event Logs screen to filter events.

Figure C.5 Filter Dialog Box

1 Select an Operator ID.

2 Select a Date Range.

3 Select Security Settings.

4 Select OK.

Delete Logs
Select the Delete button on the History Logs - Event Logs screen to display the Delete dialog box.

NOTE The Delete option is not available unless the current filter is set to All Operators, All Entries.

C-4 629743AE
Logs
HIstory Logs (Menu > Logs) C

Figure C.6 Delete Dialog Box

1 Select entries to delete.

2 Select the OK button.

629743AE C-5
Logs
HIstory Logs (Menu > Logs)

Export Logs
Select the Export button on the History Logs- Event Logs screen to display the History Logs Export
screen.

Figure C.7 History Logs Export Screen

1 Select Event Logs to export or Select All.

2 Select Data Summary Logs to export or Select All.

3 Select Maintenance Logs to export or Select All.

4 Select Audit Logs to export or Select All.

5 Select All Dates or Specify Date Range.

6 Select a Destination.

C-6 629743AE
Logs
HIstory Logs (Menu > Logs) C

7 Select OK.

Autoprint
Refer to the , Auto Print History Log Configuration section of the Setup chapter for instructions on
setting up Autoprint for History Logs.

Event Logs - General


Figure C.8 History Logs - Event Logs - General Screen

Review Logs
From the General Tab, select the Log that you want to mark as reviewed and select the Review
button.

629743AE C-7
Logs
Data Summary Logs

Data Summary Logs

Data Summary Logs

Select Data Summary Logs from the Log Type drop-down list. The Data Summary Log screen displays
two tabs of History Logs: Supplies and Daily Checks.

Figure C.9 History Logs - Data Summary Logs - Daily Checks Screen

C-8 629743AE
Logs
Audit Logs C

Audit Logs

Select Audit Logs from the Log Type drop-down list to display the Audit Logs.

Figure C.10 History Logs - Audit Log Screen

629743AE C-9
Logs
Maintenance Logs

Maintenance Logs
Select Maintenance Logs from the Log Type drop down list to display Maintenance logs.

Figure C.11 History Logs - Maintenance Logs - Maintenance Tab Screen

Add a New Maintenance Log

1 Select the New Entry button to display the New Log Entry dialog box.

C-10 629743AE
Logs
Maintenance Logs C

Figure C.12 New Log Entry

2 Type a Message in the text box.

3 Type a Comment in the text box. (Optional)

4 Select the OK button to save the new Maintenance Log.

629743AE C-11
Logs
Print History Logs

Print History Logs

Select the Print icon at the top of the History Logs screen to print History Logs.

Figure C.13 Print Dialog Box

1 Select a Print Range.

2 Select the Print Details check box to print details.

3 Select OK.

C-12 629743AE
APPENDIX D

Reports

Reports

This appendix provides examples of the following reports:


• Patient Lab Report
• Patient Chartable Report
• Patient Cumulative Report
• QC Run Details
• QC Summary Report
• QC Summary Graphical Report
• Extended QC Summary Report - HCT
• Extended QC Summary Report RBC
• Extended QC Summary Report HGB
• Extended QC Summary Report - WBC
• XB Batch Details
• XB Batch Means
• XM Batch Details - CBC
• XM Batch Means-RETIC CALC
• Levey Jennings

The first example, Figure D.1, Patient Lab Report, displays footer details that reflect variable
flagging sensitivity. The second line of the footer, left hand side, represents the algorithm revision
and, in brackets, the variable flagging sensitivity. Here, [333] indicates that all the sensitivities are
set to High [3]. Other possible values are shown below.

DisabledLowMediumHigh
(X _ _)Variant LY123

(_ X _)Left Shift0123

(_ _ X)Immature Granulocytes123

629743AE D-1
Reports
Reports

Figure D.1 Patient Lab Report

D-2 629743AE
Reports
Reports D

Figure D.2 Patient Chartable Report

Patient Chartable Report

Specimen ID: 89299430487 Panels: CBC


Specimen Type: Whole blood Flag Set: Adult Priority: Routine
Physician: Diagnosis:

Name: Patient ID:


Gender: Unknown Age:
Location:
Comment:

Panels Date Time Tube Pos Instrument Operator ID


C (C) 08/11/2008 09:52:10 AM 00220 DxH8001 SYSTEM

Test Result Flags Units Low High


WBC 5.3 10^3/uL 4.3 10.3
UWBC 5.3 10^3/uL 4.3 10.3
RBC 4.99 10^6/uL 4.38 5.77
HGB 14.9 g/dL 13.6 17.2
HCT 42.9 % 39.5 50.3
MCV 86.1 fL 80.7 95.5
MCH 30.0 pg 27.2 33.5
MCHC 34.8 g/dL 32.7 35.6
RDW 13.1 % 11.8 14.3
RDW-SD 38.1 fL
PLT 211 10^3/uL 156 373
MPV 8.8 fL 6.9 10.8

Comment:

Final Report
DevOp Printed 08/11/2008 09:55 AM Page 1 of 1

629743AE D-3
Reports
Reports

Figure D.3 Patient Cumulative Report

Patient Cumulative Report

Name: Patient ID:


Gender: Unknown Age:
Location:
Comment:

Most Recent Whole blood Specimen


Specimen ID: 89299430487 Panels: CBC
Specimen Type: Whole blood Flag Set: Adult Priority: Routine
Physician: Diagnosis:
Most Recent
08/11/2008 Units Reference Range
09:52 AM Low High

WBC 5.3 10^3/uL 4.3 10.3


UWBC 5.3 10^3/uL 4.3 10.3
RBC 4.99 10^6/uL 4.38 5.77
HGB 14.9 g/dL 13.6 17.2
HCT 42.9 % 39.5 50.3
MCV 86.1 fL 80.7 95.5
MCH 30.0 pg 27.2 33.5
MCHC 34.8 g/dL 32.7 35.6
RDW 13.1 % 11.8 14.3
RDW-SD 38.1 fL
PLT 211 10^3/uL 156 373
MPV 8.8 fL 6.9 10.8

NE % 41.4 73.0
LY % 19.4 44.9
MO % 5.1 10.9
EO % 0.9 6.0
BA % 0.3 1.5
NE# 10^3/uL 2.1 6.1
LY# 10^3/uL 1.3 3.5
MO# 10^3/uL 0.3 0.9
EO# 10^3/uL 0.0 0.5
BA# 10^3/uL 0. 2
NRBC /100WBC 1.0
NRBC# 10^3/uL 0. 1

RET % 0.52 3.53


RET# 10^6/uL 0.0200 0.1600
MRV fL
IRF

Printed 08/11/2008 09:56 AM Page 1 of 1

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Figure D.4 QC Run Detail Report Page 1 of 2

QC Run Detail Report

Lot Number: 149021948 Exp. Date: 09/25/2008 LIS Status: Not Sent
Source: BCI Instrument: DxH8001 Shift: 1
Control Type: COULTER 6C Cell Tube Pos ID: 00018 System Messages:
Level: Level 3 Run Date/Time: 08/11/2008 07:23:13 AM
Excluded: No Presented By: SYSTEM
Presentation: Automatic Reviewed By: DevOp
Review Date/Time: 08/11/2008 07:29 AM

Test Result Flags Units Upper Limit Lower Limit SM Error SM Error
Limit (%) Diff%
WBC 8.9 10^3/uL 9.6 8.2 6.50 0.00
RBC 5.12 10^6/uL 5.39 4.93 4.00 -0.78
HGB 16.2 g/dL 16.6 15.2 4.00 1.89
HCT 46.0 % 49.9 42.9 5.00 -0.86
MCV 89.8 fL 94.5 85.5
MCH 31.7 pg 32.6 29.0
MCHC 35.3 g/dL 37.0 31.2
RDW 14.2 % 16.6 11.6
RDW-SD 45.9 fL 58.6 36.6
PLT 227 10^3/uL 266 216 8.50 -5.81
MPV 9.6 fL 11.3 7.3
NE 67.6 H % 64.0 54.0
LY 15.0 L % 29.5 19.5
MO 7.6 % 11.7 5.7
EO 9.8 % 11.7 3.7
BA 0.0 % 0.5 0.0
NE# 6.0 10^3/uL 7.2 3.2
LY# 1.3 10^3/uL 3.8 0.6
MO# 0.7 10^3/uL 1.6 0.0
EO# 0.9 10^3/uL 2.1 0.0
BA# 0.0 10^3/uL 0.1 0.0
NRBC 19.9 /100WBC 21.6 15.6
NRBC# 1.8 10^3/uL 1.9 1.3
Comments: INF/DAT Filename: 2008-08-11T07-23-13_149021948_00018_121

Printed 08/11/2008 09:01 AM Page 1 of 2

629743AE D-5
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Figure D.5 QC Run Detail Report Page 2 of 2

QC Run Detail Report

5PD1 5PD2

NRBC1 NRBC2

Printed 08/11/2008 09:01 AM Page 2 of 2

D-6 629743AE
Figure D.6 QC Summary Report
D-7

Reports
Reports
QC Summary Report

Control Type: COULTER 6C Cell Lot Number: 149021948 Source: BCI


Level: Level 3 Expiration Date: 09/25/2008 Instrument: DxH8001
Report Filter: None First Run: 08/07/2008 02:31 PM Last Run: 08/11/2008 07:23 AM
Control File Comments:
Review Date Operator Analysis Date Md. Ex. WBC RBC HGB HCT MCV MCH MCHC RDW RDW-SD PLT
MPV
08/07/2008 02:43:16 PM DevOp 08/07/2008 02:31:31 PM C N 8.8 5.21 16.3 46.6 89.4 31.3 35.0 14.4 46.4 233
9.6
08/08/2008 10:17:28 AM DevOp 08/08/2008 10:07:10 AM C N 9.0 5.22 16.2 46.7 89.4 31.1 34.7 14.5 46.4 235
9.7
08/11/2008 07:19:39 AM DevOp 08/11/2008 07:17:27 AM C N 8.9 5.18 16.2 46.7 90.2 31.3 34.7 14.3 46.4 232
9.7
08/11/2008 07:29:47 AM DevOp 08/11/2008 07:23:13 AM C N 8.9 5.12 16.2 46.0 89.8 31.7 35.3 14.2 45.9 227
9.6

Summary Statistics: WBC RBC HGB HCT MCV MCH MCHC RDW RDW-SD PLT
N 4 4 4 4 4 4 4 4 4 4
Diff 0.0 0.02 0.3 0.1 -0.3 0.6 0.8 0.3 -1.3 -9
Mean 8.9 5.18 16.2 46.5 89.7 31.4 34.9 14.4 46.3 232
2SD 0.2 0.09 0.1 0.7 0.8 0.5 0.6 0.3 0.5 7
%CV 0.92 0.87 0.31 0.72 0.43 0.80 0.82 0.90 0.54 1.47
Target 8.9 5.16 15.9 46.4 90.0 30.8 34.1 14.1 47.6 241
Limit 0.7 0.23 0.7 3.5 4.5 1.8 2.9 2.5 11.0 25

MPV
N 4
Diff 0.4
Mean 9.7
2SD 0.1
%CV 0.60
Target 9.3
Limit 2.0

Printed 08/11/2008 09:02 AM Page 2 of 2


629743AE
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Figure D.7 QC Summary Graphical Report

D-8 629743AE
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Figure D.8 Extended QC Summary Report - HCT

Extended QC Summary Report - HCT

Parameter Control
Parameter ID: Lot Number: 149021948
Parameter Name: Hematocrit Control Name: COULTERfi 6C Cell
Manufacturer: BCI
Units: % Measurement Principle: Calculated
Specimen Type: Whole Blood Level: Level 3
Instrument ID: IMP032_DxH800 Expiration Date: 09/25/2008

Basic Data Limits(%)


Lab Information: Random Error: 3.00
Target: 46.4 Systematic Error: 3.00
SM Low Limit: 44.1 SM Error: 5.00
SM High Limit: 48.7

Statistics
First Run Date: 08/07/2008 Mean: 46.5
Last Run Date: 08/11/2008 SD: 0.34
Number of Runs: 4 CV: 0.72
Minimum: 46.0 Delta Diff%: 0.2
Maximum: 46.7 RMSE: 0.31

Additional Information:

Date Comment Ex Operator Result Diff% 44.1 46.4 48.7

08/07/2008 02:31:31 PM SYSTEM 46.6 0.43


08/08/2008 10:07:10 AM SYSTEM 46.7 0.65
08/11/2008 07:17:27 AM SYSTEM 46.7 0.65
08/11/2008 07:23:13 AM SYSTEM 46.0 -0.86

Printed 08/11/2008 09:03 AM Page 1 of 1

629743AE D-9
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Figure D.9 Extended QC Summary Report RBC

Extended QC Summary Report - RBC

Parameter Control
Parameter ID: Lot Number: 149021948
Parameter Name: Red Blood Count Control Name: COULTER 6C Cell
Manufacturer: BCI
Units: 10^6/uL Measurement Principle: Impedance
Specimen Type: Whole Blood Level: Level 3
Instrument ID: IMP032_DxH800 Expiration Date: 09/25/2008

Basic Data Limits(%)


Lab Information: Random Error: 2.50
Target: 5.16 Systematic Error: 3.00
SM Low Limit: 4.95 SM Error: 4.00
SM High Limit: 5.37

Statistics
First Run Date: 08/07/2008 Mean: 5.18
Last Run Date: 08/11/2008 SD: 0.045
Number of Runs: 4 CV: 0.87
Minimum: 5.12 Delta Diff%: 0.44
Maximum: 5.22 RMSE: 0.05

Additional Information:

Date Comment Ex Operator Result Diff% 4.95 5.16 5.37

08/07/2008 02:31:31 PM SYSTEM 5.21 0.97


08/08/2008 10:07:10 AM SYSTEM 5.22 1.16
08/11/2008 07:17:27 AM SYSTEM 5.18 0.39
08/11/2008 07:23:13 AM SYSTEM 5.12 -0.78

Printed 08/11/2008 09:03 AM Page 1 of 1

D-10 629743AE
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Figure D.10 Extended QC Summary Report HGB

Extended QC Summary Report - HGB

Parameter Control
Parameter ID: Lot Number: 149021948
Parameter Name: Hemoglobin Concentration Control Name: COULTER 6C Cell
Manufacturer: BCI
Units: g/dL Measurement Principle: Photometric
Specimen Type: Whole Blood Level: Level 3
Instrument ID: IMP032_DxH800 Expiration Date: 09/25/2008

Basic Data Limits(%)


Lab Information: Random Error: 2.00
Target: 15.9 Systematic Error: 2.00
SM Low Limit: 15.3 SM Error: 4.00
SM High Limit: 16.5

Statistics
First Run Date: 08/07/2008 Mean: 16.2
Last Run Date: 08/11/2008 SD: 0.05
Number of Runs: 4 CV: 0.31
Minimum: 16.2 Delta Diff%: 2.0
Maximum: 16.3 RMSE: 0.33

Additional Information:

Date Comment Ex Operator Result Diff% 15.3 15.9 16.5

08/07/2008 02:31:31 PM SYSTEM 16.3 2.52


08/08/2008 10:07:10 AM SYSTEM 16.2 1.89
08/11/2008 07:17:27 AM SYSTEM 16.2 1.89
08/11/2008 07:23:13 AM SYSTEM 16.2 1.89

Printed 08/11/2008 09:03 AM Page 1 of 1

629743AE D-11
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Figure D.11 Extended QC Summary Report - WBC

Extended QC Summary Report - WBC

Parameter Control
Parameter ID: Lot Number: 149021948
Parameter Name: White Blood Count Control Name: COULTER 6C Cell
Manufacturer: BCI
Units: 10^3/uL Measurement Principle: Impedance
Specimen Type: Whole Blood Level: Level 3
Instrument ID: IMP032_DxH800 Expiration Date: 09/25/2008

Basic Data Limits(%)


Lab Information: Random Error: 4.00
Target: 8.9 Systematic Error: 5.00
SM Low Limit: 8.3 SM Error: 6.50
SM High Limit: 9.5

Statistics
First Run Date: 08/07/2008 Mean: 8.9
Last Run Date: 08/11/2008 SD: 0.08
Number of Runs: 4 CV: 0.92
Minimum: 8.8 Delta Diff%: 0.0
Maximum: 9.0 RMSE: 0.07

Additional Information:

Date Comment Ex Operator Result Diff% 8.3 8.9 9.5

08/07/2008 02:31:31 PM SYSTEM 8.8 -1.12


08/08/2008 10:07:10 AM SYSTEM 9.0 1.12
08/11/2008 07:17:27 AM SYSTEM 8.9 0.00
08/11/2008 07:23:13 AM SYSTEM 8.9 0.00

Printed 08/11/2008 09:03 AM Page 1 of 1

D-12 629743AE
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Figure D.12 XB Batch Details Report (Example) Page 1 of 2

629743AE D-13
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Reports

Figure D.13 XB Batch Details Report (Example) Page 2 of 2

D-14 629743AE
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Reports D

Figure D.14 XB Batch Means (Example)

629743AE D-15
D-16

Reports
Reports
Figure D.15 XM Batch Details Report (Example)
629743AE
629743AE

Figure D.16 XM Batch Means-RETIC CALC Report (Example)

Reports
Reports
D-17

D
D-18

Reports
Reports
Figure D.17 Example of Levey Jennings on a Report
629743AE
Glossary

This glossary is a collection of specialized terms and their meanings that are either used in this
manual or related to the information in it. If a term has more than one meaning, all meanings
relevant to this manual are included.

°
degrees (temperature only)

μ
micron

ALL
axial light loss

AMTC
Air Mix and Temperature Control Module

absolute count

Concentration of a cell type expressed as a number per volume of whole blood.

accuracy

The ability of the instrument to agree with a predetermined reference (true) value.
accurate

The reported measurement is in agreement, within acceptable limits, of the preferred reference
standard. Sometimes specified as the difference of the means of a sample to the assay or
expected value (mean difference) or the percent difference of the means of a sample to the assay
or expected value (percent mean difference).

action limits

The limits for a test value, such that if the value is outside of the limits, some future action or
review is suggested (for example, repeat test, review blood smear, etc.)

active result
A result associated with an active test order.

active test order

Test order for which one or more results for one or more specimens have not been released or
released and not yet reported.

administrator

Somebody whose job is to administer the affairs of a business or organization.

629743AE Glossary-1
Glossary

advanced operator

An operator who has been given authority beyond that of a basic operator.

alert

A fault condition classification for events occurring on the DxH 800 System. An alert occurs
when a condition exists on the system for which corrective actions must be taken in order for
specimen results to be reported. This condition has no immediate effect on the system
operation as the system does not stop. The system alerts the operator by triggering visual
alarms, and if applicable, audible alarms. Alerts are not logged to the Event Log. All alerts
require operator review; however, the method of review is specific to the individual event.

algorithm

A particular procedure for performing an analysis.

amended report

A patient report that is dispatched subsequent to any change made to the patient’s results if the
specific patient report was dispatched previously, prior to the changes.

analyze
To process a sample to determine the results for a test or tests.

analyzer

An analytical or preparation unit composed of one or more modules.


anticoagulant

A substance added to blood to prevent clotting.

aperture
An opening of a specific size and length through which cells pass for counting and sizing.

application Software

SPM or System Manager software that controls and implements the DxH 800 System.
aspiration probe

Device which pierces the cap and through which the sample is aspirated.

assay values

Values established for a control by extensive analysis of that material.

assembly

A replaceable part that comprises more than one component.

Glossary-2 629743AE
Glossary

audit log

A general record showing any changes that the operators have made on the system, including
configuration, patient, and QC. Data in the Audit log is kept up to a period of 2 years after which
the system will “roll over” the log data.

audit trail
A record of a sequence of events, as actions performed by the operator, from which a history can
be reconstructed for a specific area of the system. For example, a patient audit trail will have
changes related to patient data. Audit trails are maintained for as long as the data is maintained
on the system.

auto collation

A System Manager feature that automatically combines results of different test modes (CBC/Diff
and Retic) analyzed from a sample with an identical patient or sample ID. The different test
modes must be performed within a predetermined time.

autostop

Automatic (for example, without a specific user request) stopping of specimen analysis on the
SPM because of some condition that was detected by the system. Several conditions can result
in an autostop. For the DxH 800 System, the autostop conditions are configurable.

available tests

All the tests which an instrument is capable of performing.

assay values

Values for a control established by extensive repeat testing of that control.

assembly

A specific set of components physically attached together or to a common structure. The


components do not have to be related functionally and may not qualify as a sub-system
(completeness of functionality). An assembly is modular only when it has the attributes of
modularity.

BFC
Body Fluid Count

BSV
Body Sampling Valve

backup

To store data separately from the active data, while leaving the active data in place. Backups can
be done completely, meaning that all of the selected data is backed up, or incrementally,
meaning that only the changes are backed up.

background count

Measure of the amount of electrical or particle interference.

629743AE Glossary-3
Glossary

base test

A test that is determined for a method, directly measured by an instrument (for example, WBC,
for a CBC analysis), or a test that is derived from the RBC or PLT histogram.

basic operator

An operator with only limited authority to operate the system.

basophil

A mature granulocyte WBC with granules that contain heparin and vasoactive compounds. The
granules stain purple-blue with Wright’s stain.
batch

A group or set of results.

batch mean

The mean or average of a set of examples.

bi-directional

The capability to send test results to (upload) and receive test results from (download) the LIS
system.
board

Circuit board not directly connected to a host board or backplane using a card edge connector;
typically has a moderate to high density of components.

body fluid count

The DxH 800 CBC module generates a simple panel for body fluid specimens composed of RBC
and TNC.

body fluids

Fluids that are excreted, secreted, or derived form the human body. Some examples are:
cerebrospinal fluid (brain and spinal cord), pericardial fluid (heart), peritoneal dialysis fluid
(abdomen), peritoneal lavage fluid (abdomen), peritoneal tap fluid (abdomen), pleural fluid
(lungs), and synovial fluid (joints).

CBC
Complete Blood Count

CD
CBC/Diff

CLSI
Clinical and Laboratory Standard Institute formerly known as the National Committee for
Clinical Laboratory Standards (NCCLS).

Glossary-4 629743AE
Glossary

CDR
CBC/Diff/Retic

CR
CBC/Retic

CSF
Cerebrospinal Fluid

CS
Common Services
calibration

The procedure used to set an instrument at a specific value or values using a reference method.

calibration factor
A numerical factor applied to a result determined by an instrument, in order to establish an
agreement between the instrument’s measurement and a reference value.

calibrator

A substance with values obtained by reference instruments and used to calibrate instruments.

card

Circuit board with a card edge connector that plugs into a host board or a backplane; typically
has a moderate to high density of components.
carryover

The amount, in percent, of sample remaining in the system and picked up by the next sample
cycled. Low-to-high carryover is the amount of sample with low cell concentrations carried over
to samples with high cell concentration, such as diluent to blood. High-to-low carryover is the
amount of samples with high cell concentrations carried over to samples with low cell
concentrations, such as blood to diluent.
cassette

A type of specimen carrier.

cassette presentation

The SPM accepts specimens presented at the automatic entry point, delivered by cassette.

CBC analytical module

A partition of the Specimen Processing module (SPM) that produces CBC raw data.

characters

All letters A-Z and numbers 0-9.

629743AE Glossary-5
Glossary

cleaning agent

A detergent used to flush sample from tubing and eliminate protein buildup.

cleared

When a specimen has been seen by the system, but it could not be processed, a notification for
the specimen is placed on the “Not Processed Filter” of the Worklist. “Cleared” means that one
of these notifications has been removed.

closed vial

The sampling of a specimen by piercing the cap of the container.


coefficient of variation (CV or CV%)

An expression, in percent (%), of the data spread (variation) as related to the mean value. CV,
CV%, and coefficient of variation may be used interchangeably. The standard formula for
calculation:
SD
CV% = --------------- × 100
Mean
coincidence correction

Mathematical adjustment of cell count and size for coincidence error.

coincidence error

Errors produced in counting and sizing by the presence of more than one cell within the
aperture sensing area at the same time. The system senses these as one large cell rather than as
two distinct cells.
common services

A functional module that consolidates a set of services and becomes a common source of those
services for several other modules. It comprises the Reagent Services, Pneumatic Services,
Pneumatic Supply and Electronic Supply.

component

A subassembly or other constituent part of a module.

complete blood count (CBC)

In the DxH 800 System, whole blood parameters RBC, WBC -u, WBC -c, HGB, HCT, MCV, MCH,
MCHC, PLT, RDW, MPV, PCT, and PDW.
computed test

A test that is calculated based on the results of one or more discrete tests.

Glossary-6 629743AE
Glossary

configured tests

The tests for the SPM that have not been disabled by the operator via the configuration options
described in this manual.

conforming vial

A cap-pierceable vial that can be placed directly into a tube holder or cassette.

consensus rules

Generally accepted guidelines (rules), developed by the International Consensus Group for
Hematology’s (ISLH) Review. The rules can be applied to criteria for review of CBC and
differential results from automated hematology analyzers.

consumable

A component that is required by the physical system during operation and is typically disposed
of after a single use or a finite number of usages. This includes such items as calibrators,
controls, liquid reagents, etc.

control

A substance with predetermined values used as a standard to verify accuracy of instrument


results.

control file

A set of retrieved control results and the expected results associated with them. Each control
file contains results from a single instrument and a single control lot or specimen.

critical limits

The limits for a test value, such that if the value is outside of the limits, the patient’s life may be
threatened and immediate action and notification is required.

critical result

A result considered sufficiently abnormal as to warrant immediate notification of the physician.

cyclic redundancy check (CRC)

A common technique for detecting data transmission errors.

dB
Decibel

DIFF
White Blood Cell Differential

DV
Distribution Valve

629743AE Glossary-7
Glossary

dataplot

A graphic representation of results. Dataplots present a combined view of population density


and membership. Colors represent different types of cells. Shades of colors represent the
number of cells--bright colors are the most dense.

dead volume
The volume of fluid in its container (for example, reagent bottle or specimen tube) that the SPM
cannot access.

deciliter (dL)

A unit of volumetric measurement equal to 0.1 liter.

decision rules

Typically, user-defined “if, then” statements specifying an action to be taken dependent on the
outcome (for example, test values, flags) of a test. These are programmed at the System Manager
to allow automatic responses.

default

Original setting in the SPM or System Manager.

default test order

A test order that is generated when a specimen is presented to the system and a previously
submitted test order cannot be found for it. The tests on the order will depend on the method
of presentation (Cassette or Single-Tube).

default tests

The tests that may be assigned to a test order for a specimen that cannot be positively identified,
or for which a test order cannot be located.

deionized water

Water freed of salt and some organisms by an ion-exchange process. This water can be used
interchangeably with distilled water in procedures. Also referred to as DI H2O or DI water.

deleted

A test order, with or without associated results, that has been completely removed from the
system. That is, the Test Order is no longer available on either the active or inactive Test Order
lists. Furthermore, if there were any results associated with the test order, they are no longer
available.

delta check

A check on sample results that is made by clinical laboratories to determine if the current result
on a particular patient is within certain limits of the last result obtained on that same patient.

Glossary-8 629743AE
Glossary

density

The number of cells in a particular region, regardless of the type of cell.


On dataplots, as more cells appear in a particular region, the color of the region gets brighter.

Diff%

Used to represent the individual differential % tests, which includes: NE%, LY%, MO%, EO% and
BA%. Diff % does not include NRBC.

Diff#
Used to represent the individual count tests, which includes: NE#, LY#, MO#, EO# and BA#. Diff#
does not include NRBC#.

differential (Diff)

Leukocyte or white blood cell differential. In this manual, a five-part differential.

discrete test

Refers to either a base test or computed test (for example, WBC which is a base test or HCT which
is a computed test).
distilled water

Water freed of solids and organisms by distillation. This water can be used interchangeably with
deionized water in procedures.
distribution valve (DV)

An electrically driven ceramic face sealing valve in the VCSn functional module that routes
sample/reagents between the mixing chambers, the flow cell, and the VCS diluent pump.
download

Data transmitted from an LIS system to a clinical System Manager.

down-time

Any time the system is not available for testing.

DxH 800 System

An interacting group of components (SPM, System Manager, and Pneumatic Supply Module).
See also, system.

EDMA
European Diagnostic Manufacturers Association

EDTA
Ethylene Diamine Tetra Acetic Acid. A common anticoagulant used for hematological testing.

629743AE Glossary-9
Glossary

entry point

The physical place where the specimen first becomes known to the system, for example, at the
Manual Station for Single-Tube presentation and at the Input Buffer for Cassette presentation.

eosinophil

A mature granulocyte WBC that responds to parasitic infections and allergic conditions.
Granules stain a bright reddish orange with Wright’s stain.

error

A fault condition classification for events occurring on the DxH 800 System. An error occurs
when a condition exists on the system for which the operator must take corrective action.
Operation of the system or a component was affected or may have been halted, and action is
required in order to recover the situation. Action may be unrecoverable and may consist of
contacting your Beckman Coulter Representative. The system alerts you of an error by
displaying messages and triggering visual and audible alarms. If an error has an impact on an
the SPM’s operation, the an Operational Status Indicator for the SPM will be triggered. Messages
related to the event will be posted to the Event Log by filter category. All errors require
acknowledgement or review; however, how each error is acknowledged or reviewed is specific
to the event.

error message
A classification of messages that are put into the Event Log. Indicates that messages posted to
the Event Log are intended to alert the operator of an error. The Event Log visual indicator is
triggered consistent with an error. Audible alarms are also triggered. Error messages post to the
Event Log for the General category filter only. The operator is required to review or
acknowledge the message in order to clear the Event Log visual indicator.

erythrocyte (red blood cell)


A biconcave disc, 6 to 8 m, that carries oxygen to the tissues in the body and carries carbon
dioxide away from the tissues.

ethylenediaminetetraacetic acid (EDTA)


A common anticoagulant used for hematological testing.

event

A noteworthy occurrence; something that needs to be logged.


exception
A message that indicates why a specimen was not processed or skipped, or a default test order
or no match occurred.
expiration date

A manufacturer’s recommended last day of use for a reagent, control, or calibrator.

Glossary-10 629743AE
Glossary

export

To format and store data so that it can be used by external programs (for example, Microsoft
Excel or Word).

extended differential

Includes identification of rare or abnormal white blood cell types not identified in the standard
5-part differential, in addition to the 5-part differential parameters.

extended QC

Additional QC rules for verification of the following:


• Random error or Imprecision
• Systematic error or Bias
• Total error or Inaccuracy
FC
Flow Cell

feature

Any prominent or distinctive aspect, quality or characteristic.


femtoliter (fL)

Femtoliter, a unit of volumetric measurement equal to 10-15 liter.

field replaceable assembly

A functional, testable assembly that replaces a portion of a module. This can include such parts
as a circuit board, flow cell, laser, etc.

flags

A flag is a single letter or symbol and will always appear to the right of a result. A flag can be
instrument generated (R, P), or laboratory-defined (H, L, c, a). On screens and printouts, the
letters, such as H, L, and R appear next to parameter results to indicate specific conditions.

field replaceable unit

A completely functional tested assembly. This can include such assemblies as a complete Diff
Module, MTM, power supply, CBC Module, Sample Aspiration Module, etc.

flow cell (FC)

A device used to guide particles as they pass through a laser beam one at a time in a stream of
fluid called sheath. This sheath fluid aligns the sample with the center of the flow cell.

flow cytometry

A process for measuring the characteristics of cells or other biological particles as they pass
through a measuring apparatus in a fluid stream.

629743AE Glossary-11
Glossary

field replaceable unit (FRU)

A completely functional tested assembly.

final report

Any patient report dispatched subsequent to the entire set of patient’s results being final
released.

five-part differential

Classifying leukocyte cells into five sub-populations (neutrophils, lymphocytes, monocytes,


eosinophils and basophils).
flagging

The ability of a system to identify and alert the operator to the presence of possible anomalies
that may affect the accuracy of a test result or require additional work to be performed.

functional modules
System processes that require inputs and interactions between multiple modules and/or
assemblies to produce the required outputs.

Gaussian distribution

A normal or symmetrical distribution; for example, a bell-shaped curve.

giant platelets

Platelets above 20 fL in size.

gram (g)

A unit of weight.

ground state

The energy level having the least energy of all its possible states and greatest stability. For
example, the resting state of an atom is referred to as its ground state.

H&H
HgB/Hct

hardware modules

Replaceable, testable units that comprise multiple components and/or assemblies.

hematocrit (HCT)

Red cell packed volume. The percentage of packed red cells compared to the entire blood
sample.
hemoglobin (HGB)

A protein component of red cells that carries oxygen and carbon dioxide.

Glossary-12 629743AE
Glossary

Hemoglobinometry

Measurement of hemoglobin in the blood.

hertz (Hz)

A unit of frequency.

histogram

A graphical display of the cell size distribution of a blood sample, where size is on the X-axis and
frequency is on the Y-axis.

hold
When an individual test value, panel or set of test results is identified as requiring further
review and verification prior to release.

host

A device with customized drivers that receives the SPM patient or control information
electronically and formats the data so the LIS can interpret it.

host query

When a clinical instrument requests test information for a particular specimen from the LIS
system.

IQAP
Inter-Laboratory Quality Assurance Program
IQM
Intelligent Quality monitoring (IQM) monitors event notification and recovery within the
system on an on-going basis. IQM monitors sensor and hardware status in real-time, and also
provides tracking and trending of event notifications via the Alert Status icons, alarms and the
History Event Log. Events can be addressed as they occur. The availability of IQM optimizes
system availability and minimizes possible repeat patient testing for failed QC.

IVD
In Vitro Diagnostics

immature reticulocyte fraction (IRF)


The ratio of immature reticulocytes to the total number of reticulocytes.

impedance calibrator

Beckman Coulter products also known as Latex particles that contain polystyrene beads of
uniform and appropriate size to allow standardization of the DC characteristics of Beckman
Coulter apertures, and/or the DC and RF characteristics of flow cells for products use VCSn
technology. These products are used by service to calibrate SPMs.

629743AE Glossary-13
Glossary

imprecision

The degree to which a result will vary due to random error when measured several times on the
same instrument.

in vitro

Outside of a living organism, such as in a laboratory or in an artificial container.

in vivo

Inside a living organism, associated with the physiological system.

inactive result
A result associated with an inactive test order.

inactive test order

Test order for which all results for all specimens have been final released and reported, or test
order was removed.

indices

In hematology, refers to the following calculated values for red cell properties: MCV, MCH, and
MCHC.
information

An information event occurs when a message is logged to the Event Log for tracking and/or
troubleshooting purposed. This event has no effect on the system operation and the operator is
not alerted. An information event is logged to the Event Log by filter category and does not
require operator acknowledgement or review. An action may eventually be needed in order to
prevent problems in the future.
input buffer

Place for loading cassettes.

instrument

An analytical or preparation unit composed of one or more modules.

interfering substances

Components within a blood sample that complicate or obstruct the measurement of the desired
parameters.

Inter-laboratory Quality Assurance Program (IQAP)

A program administered by Beckman Coulter, Inc. for users of its hematology instruments and
controls. It allows a laboratory to compare its performance to all other laboratories in the
program that use the same or similar instrument category and control products.

Glossary-14 629743AE
Glossary

LALS
Low Angle Light Scatter

LIS
Laboratory Information System

LMALS
Lower Median Angle Light Scatter

lab administrator

An individual who has responsibility for running a laboratory.

laminar flow

The flow of two liquids side by side in which one does not mix with the other.

laser

Light amplification by stimulated emission of radiation.


leukocyte (white blood cell)

Cells that defend the body against disease.

linearity
The ability of an instrument to accurately produce a test result over the range of possible values
for a specific parameter.

liter (L)

A unit of volumetric measurement.

LIS query

When a clinical instrument requests test information for a particular specimen from the LIS
system.

log

A record of certain system occurrence or events.

lot number

An identifier assigned by a manufacturer to identify a control, reagent or calibrator.

lymphocyte

WBC originating in the lymph system. The key to the body’s immune system, the lymphocyte
recognizes and eliminates foreign pathogens in the body.

lyse

To break apart or dissolve.

629743AE Glossary-15
Glossary

MALS
Median Angle Light Scatter

MCH
Mean Corpuscular Hemoglobin

MCHC
Mean Corpuscular Hemoglobin Concentration

MCV
Mean Cell Volume
MRC
Module Resource Controller

MTM
Multi-Transducer Module

manual station

The entry point for Single-Tube presentation.

mean
Arithmetic average of a group of data.

mean cell volume (MCV)

Average volume of red blood cells expressed in fL.


mean corpuscular hemoglobin (MCH)

The weight of hemoglobin in the average red blood cell expressed in picograms.

mean corpuscular hemoglobin concentration (MCHC)


The weight of hemoglobin in the packed red cell volume expressed in g/dL or g/L.

mean platelet volume (MPV)

Average volume of platelets expressed in fL.


mean reticulocyte volume (MRV)

Average volume of reticulocytes expressed in fL.

mean sphered volume (MSCV)

Average volume of red cell population of reticulocyte

measuring range
Measuring range is the range of values over which the acceptability criteria for the method are
defined.

Glossary-16 629743AE
Glossary

membership

The different types of cells in a particular region, regardless of the number of cells.
On dataplots, membership is represented showing different types of cells in different colors.

message

A classification of messages that are posted to the Event Log that are for informational purposes
only. The Event Log visual indicator is not triggered. Audible alarms can be triggered depending
on the specific event. Messages can be posted to any of the Event log filter categories.
meter (m)

A unit of linear measurement.

micron (μ)

One millionth of a meter.

microprocessor

The integrated circuitry for electronically controlled devices.

milliliter (mL)

A unit of volumetric measurement equal to 10-3 liter.


millimeter (mm)

A unit of linear measurement, equal to one-thousandth of a meter.

module
A standardized assembly with well-defined interfaces and functionality, that provides a major
service to a larger system and can be used together with other modules to form a complete
system.

monocyte (MO)

A large, mononuclear, phagocytic WBC found in the peripheral blood and in the lymphoid
system.

mononuclear
Having only one nucleus.

morphology

Various conditions that can be seen by examining a blood smear, along with a semi-quantitative
estimate of the condition’s severity. The morphology can be related to red cells, white cells or
platelets.

629743AE Glossary-17
Glossary

multi-transducer module (MTM)

A set of components that produce the DC, Rf, MALS, UMALS, ALL, LALS. and LMALS-Offset
signals. It consists of the optical bench, an LALS pre-amp board and the diff pre-amp board.
Electrical signals and laser light are passed through the flow cell such that particles flowing
through the flow cell will perturb the signals listed above and cause a variety of transducers
(antennas, light sensors) to produce other electrical signals which are then measured to
produce raw data.

nanometer (nm)

A unit of linear measurement equal to 10-9 meter.

neutrophil
A mature granulocytic WBC characterized by a segmented nucleus. The cytoplasm of this
phagocyte stains pinkish to beige with faint granules in Wright’s stain.

non-conforming vial
May not be cap-pierceable vial, or may not fit into cassette or single-tube station cradle.

nucleated red blood cell (NRBC)

Immature form of the red blood cell characterized by the presence of a nucleus.
offline

SPM is not participating in specimen scheduling, specimen delivery or specimen processing.

online

SPM is participating in specimen scheduling, specimen delivery and specimen processing.

opacity

A transformation of the data derived from the ratio of the RF and DC components obtained
during data acquisition. It is calculated for every individual cell measurement or event. Opacity
has the effect of removing the size component, yielding a measurement that is more closely
related to the internal contents of the cell.
RF
OP ≈ --------
DC

open vial

The sampling of a specimen (blood, body fluid, etc.) by removing the cap from the container.

operating range

The range over which the instrument displays, prints and transmits results.

operating system (OS)

Operating system files, libraries, drivers, and so forth, required for running the application.

Glossary-18 629743AE
Glossary

operating System Core

Operating system files, libraries, drivers, etc., required for running the application.

operator

An individual with authority to operate the system.

operator ID

Uniquely identifies the processor of the samples.

Operator (Level I)

Normal operator - has low level privileges to the system software.

Operator (Level II)

Advanced operator - has medium level privileges to the system software.

Operator (Level III)

Lab administrator operator - has full level privileges to the system software.
Operator (System)

Default operator - the system uses this operator when no one is logged in to the system software,
but the system is processing specimens. Limited to processing specimens only.
Operator (Temp Admin)

Temporary administrator operator - has full level privileges to the system software, to all
system service tools and the full operating system for one day only.
optical control

Beckman Coulter product also known as LATRON CP-X control that contains stable polystyrene
beads of uniform size and appropriate light scattering characteristics to allow monitoring of the
light scattering and fluid flow characteristics of products that use VCSn technology. You can use
this product to verify the proper functioning of the VCSn optical bench, much like using 6C
controls to verify the proper recovery of parameter values. Service also uses this product to
standardize the characteristics of flow cells.

outlier

Control results that fall outside the expected or established range.

output buffer
Where cassettes are unloaded.

panel

A grouping of two or more simple panels and/or discrete tests that can be ordered on a
specimen (for example, CD, CDR, CR, H&H, WHP, etc.).

629743AE Glossary-19
Glossary

parameter

Component of blood that the instrument measures and reports.

partial voteout

An individual aperture count that is not used in the average parameter value.

patient ID

The System Manager considers this field an optional sample identifier.


Your laboratory may use it as a specific identifier for the patient, such as the medical record or
Social Security Number. It is intended for laboratories that want to track results of several
different samples or tests for the same patient.

pericardial fluid
The serous fluid that fills the pericardial cavity (the cavity around the heart) and protects the
heart from friction.

peritoneal dialysis fluid

Used in peritoneal dialysis, it is a special solution that is run through a tube into the peritoneum,
a thin tissue that lines the cavity of the abdomen, to remove the body’s waste products.

peritoneal lavage fluid

Fluid instilled into the peritoneal cavity and subsequently withdrawn, for the removal of
elements not being excreted by the kidneys.

peritoneal tap fluid

Fluid obtained from an abdominal tap, which is a procedure in which a needle is inserted
through the abdominal wall into the peritoneal cavity to obtain a sample of any fluid that is
present.

photometric measurement

A process where a beam of white light from an incandescent lamp goes through an optical filter
and is read by a photocell. This generates a current that can be measured.

platelet (thrombocyte)
The cytoplasmic fragments of megakaryocytes, circulating as small discs in the peripheral
blood, and an essential component for blood clotting.

platelet distribution width (PDW)

An index of the variation in platelet size.

pleural fluid

The fluid that encompasses the lungs. The name comes from pleura, the serous membrane that
enfolds the lungs and is folded back upon the walls of the thorax and upon the diaphragm.

Glossary-20 629743AE
Glossary

Plt Histogram

The portion of the Plt distribution curve between 0 fL and 36 fL.

polynuclear

Having many nuclei.

positively identified

The barcode for the selected primary identifier, either the Specimen ID or Tube Position ID, was
successfully read.

power down
A predefined sequence of events performed at the System Manager to power down the System
Manager and the SPM.

power off

To remove power from an instrument.

power on

To provide power to an instrument.

power up
A predefined sequence of events performed at the System Manager to power up the System
Manager and the SPM.

precision

A measure of the ability of the instrument to reproduce similar results when a sample is run
repeatedly. May also be referred to as repeatability.

precision test

The precision test is performed as part of Daily Checks. If any test value exceeds the reference
value by 1% or more, the test value appears in red on the Daily Checks screen and is flagged with
an H (high) or L (low).

predilute

Dilution of a sample prior to analysis on the analyzer.

preliminary report

Any patient report dispatched prior to the entire set of patient’s results being final released.

presentation method

The method by which the specimen is presented to the SPM. The available methods are Cassette
Presentation and Single-Tube Presentation.

629743AE Glossary-21
Glossary

primary identifier

The unique identifier that will be used by the system to positively identify a patient specimen.

privilege

Permission to perform some particular function, for example, enter a test order or review
patient results.

probe

See aspiration probe.

processing presentation method


The method by which a specimen is presented to the SPM (Cassette Presentation or Single-Tube
Presentation).

prune

To reduce something by deleting whatever is unnecessary or unwanted.

pounds per square inch (psi)

A unit of pressure measurement.

QA
Quality Assurance

QC
Quality Control

QA/QC Operator

An operator who has authority to perform all QA (calibration) and/or QC (control) related
activities.

quality control (QC)

A set of procedures a laboratory sets up to ensure that an instrument is working accurately and
precisely.
Ramp Test

The ramp test is performed as part of Daily Checks. If any test value exceeds the reference value,
the test value appears in red on the System Manager screen and is flagged with an H (high) and
L (low).

random access

The ability to perform different tests on different specimens in random order. The opposite of
batch processing, where specimens must be grouped according to tests ordered.

random error

Imprecision or variance.

Glossary-22 629743AE
Glossary

range

The difference between the highest and lowest measurement in a series.

raw data

Unanalyzed data; data not yet subjected to analysis.

RBC histogram

An RBC distribution curve. The normal curve ranges from 36 to 360 fL. The display starts at 24 fL.

RDW (Red Distribution Width)

The size distribution spread of the erythrocyte population derived from the RBC histogram.
Expressed as coefficient of variation (%).

RDW-SD

The size distribution spread of the erythrocyte population derived from the RBC histogram.
Expressed as a standard deviation in fL.

reagent

A substance used (as in detecting or measuring a component, or in preparing a product) because


of its chemical or biological activity. (Webster)
rectify

The operator can correct the patient ID if the patient ID was entered incorrectly.

red blood cell (RBC)

See erythrocyte.

red cell indices

In hematology, refers to the following calculated values for red cell properties: MCV, MCH, and
MCHC.

reference range

A range of test values determined by statistical analysis of specimens collected from a normal
(non-diseased) population.

reflex test

A different test, panel or specimen preparation performed as a result of the outcome of an


earlier test. Usually performed for confirmation of initial results or to gain a better
understanding of a patient’s condition.

rejected

A test value, panel or set of results has been reviewed and identified as non-reportable, either
automatically because another panel in another run has been selected for release, or manually
because the operator has determined that these tests cannot be reported.

629743AE Glossary-23
Glossary

released

The test results have been automatically or manually validated and identified as reportable
outside the system’s domain, as defined by your laboratory.

remote management
An application that allows a Beckman Coulter remote user to control a System Manager with
prior authorization of lab management, allowing pro-active diagnostic support.

removed

A pending test order (no associated test results) that has been manually taken away from the
active Test Orders list and has become inactive.

repeatability

The closeness of agreement between the results of successive measurements of the same
substance carried out under the same conditions of measurement. Also known as
reproducibility, precision, within-run precision, within-assay, within-run, intra-assay, and
intra-run precision.

report
A formatted printed and/or electronic record of compiled specimen or system data.

reportable range

The range over which the instrument is accurate.


reported

The test results have been automatically or manually dispatched to a user specified destination.
The test results may or may not have been released.
rerun
The ability to repeat an analysis on a specimen using the same test.

reserved control ID

A specimen ID that cannot be used for patient specimens because a control has been configured
with a lot number that matches the Specimen ID.

restore backup
To bring backed up data back into the system so that it replaces the active data in the system
and becomes the active data itself.

result

A numerical value or values obtained by performing the analysis for a particular test.

Glossary-24 629743AE
Glossary

reticulocyte (Retic)

An immature form of red cell that, in the maturation process, falls between a nucleated RBC and
a mature RBC. As the nucleated RBC matures, the nucleus shrinks and eventually is shed, and
the RNA in the cytoplasm breaks down. The red cell without a nucleus, but still containing
remnants of the RNA, is a reticulocyte. Mature RBCs contain no RNA. Stains, such as new
methylene blue, precipitate the RNA, differentiating the reticulocytes from mature RBCs and
other cells.

role

A general category associated with the ability to perform some particular function or set of
functions, for example, a named set of privileges.

root sum squared error (RSSE)


n-----------
– 1- ⋅ s 2 + δ 2
Δ =
n
Measured within a control file Extended QC is enabled, and N is greater than or equal to 15 runs.
RSSE is a statistical result that is compared to the limits for Single Measurement Error.
run

One analysis of a specimen which generates test results.

run order

The tests ordered for a specific run of specimen, which may require more than one run of the
specimen to complete.

SAM
Sample Aspiration Module

STM
Specimen Transport Module

SPM
Specimen Processing Module

STAT
Superior turn around time, which indicates immediately.

sample

A fraction of a specimen taken for analysis on an instrument.

sample ID

One of two possible primary identifiers for sample analysis. The other possible identifier is Tube
Position ID.

629743AE Glossary-25
Glossary

sample preparation

Requires two services, acquire sample and condition sample. It consists of extracting a sample
from a specimen container, segmenting the required sample volume, then combining it with
conditioning reagents to enhance specific discrimination characteristics for measuring and
analysis. These responsibilities are delegated to an SPM.

sample volume

The volume of a specimen removed from a specimen container.


Also, the volume of a specimen that is conditioned for a specific measuring function. When the
volume removed from a specimen container exceeds the conditioning requirement and a
portion is discarded, or when portions of the sample are allocated to several conditioning
processes, the sample may be called an intermediate sample volume.

schistocytes

A type of Red blood cell fragments.

single measurement error


The possible deviation for a single measurement of a result. Single measurement error is flagged
when Extended QC is enabled, and the result exceeded the upper or lower limit for Single
Measurement Error limits entered by the operator. The Single Measurement Error is measured
within the control file as the Root Sum Squared Error (RSSE).

screen saver

The System Manager has a screen saver that appears when you are not interacting with the
System Manager. You can set up the screen saver to appear at specific intervals of non-use.
The screen returns to its normal view when the System Manager receives sample data or when
you interact with the System Manager by pressing a key on the keyboard.

secondary identifier

An identifier not configured to be the primary identifier, that can be used by the system to
identify a patient specimen in cases where the primary identifier cannot be read.

special online

Instrument is not participating in specimen delivery and specimen processing for special
procedures such as calibration, carryover, etc. This is used for procedures where specific
specimens are designated for delivery and no other specimens can be scheduled for delivery
during the procedure.
specifications

An exact statement of particulars, especially a statement prescribing materials, and dimensions


for something to be installed.
specimen processing module

Processes specimens and transmits raw data to the System Manager.

Glossary-26 629743AE
Glossary

specimen transport module

The specimen delivery module.

standard deviation (SD)

A measure of deviation from the mean. For example, a measure of the range of channel
deviation within a measurement.

SD =
∑ 〈 x – x〉 2
------------------------
N–1

sheath

A liquid which surrounds and aligns another liquid.

shift

Consecutive values that abruptly move from one level (mean) to another and then maintain a
constant level.
specimen

The discrete portion of a body fluid or whole blood taken for examination, study, or analysis.

status bar

A horizontal bar that appears toward the bottom of the screen. It displays the last event
message, operator ID, and date and time.

study

Use of the system to perform an investigation of a subject for which investigation specimens
must be analyzed, but the specimen’s results should not be transmitted to the LIS. A study might
be used to do things such as validating a new instrument, performing accuracy studies, or
evaluating performance, etc.

suspect messages

Suspect messages appear in a separate area of the screen display, printout, and host
transmission. Suspect messages, such as Imm NE 1, Platelet Clumps, etc., are system-generated.
Suspect messages appear for sample results based on an abnormal cell distribution or
population. The system generates these messages according to an internal algorithm.
Abnormalities should be confirmed by microscopic review.
synovial fluid

The viscid, transparent, albuminous fluid secreted by the synovial membranes at points where
lubrication is necessary, as in joints.

629743AE Glossary-27
Glossary

system administrator

An individual who has responsibility for administering a DxH 800 System and may perform
activities such as configuring the modules and system and performing the more non-routine
maintenance activities.

system identifier
An identifier entered at installation time and used to identify the system when calling your
Beckman Coulter Representative.

System Manager

A personal computer (PC) that:


• Provides a graphical user interface and input devices (touch screen, keyboard, and mouse)
to the operator to interact with the system. This interaction can include, but is not limited
to: ordering tests, reviewing test results, reviewing quality control results, making log
entries, and responding to system errors.
• Communicates with the LIS.
• Controls processes such as sample analysis and diagnostic procedures.
• Receives and analyzes the raw data from the SPM.
• Generates data reports.

system message
A message that may be given when a system event occurs, to provide a reason for a Review (R)
flag generated by the system.

systematic error

The bias or deviation of the mean from the target value.

sweep flow

A steady stream of diluent that flows behind the RBC aperture during sensing periods to keep
RBCs from swirling back into the sensing zone.

TNC
Total Nucleated Cells

TTM
Triple Transducer Module

test

Individual parameter for which an instrument can determine a value, either directly measured
or computed.

test order

A description of the specimens and what tests per run order are to be performed on each given
specimen contained on the test order.

Glossary-28 629743AE
Glossary

test panel

An aggregation of selected tests that, when combined, provide results of clinical diagnostic
value, but do not necessarily share common analytical technologies.

thrombocyte (platelet)

the cytoplasmic fragments of megakaryocytes, circulating as small discs in the peripheral blood,
and an essential component for blood clotting.

throughput

A measurement of rate at which an instrument can produce test results, conventionally


measured as tests per hour.

total nucleated cells

The total number of nucleated cells for a body fluid specimen.

total voteout
A code (-----) that replaces the average parameter result when there is disagreement between
the three aperture counts. The aperture counts for the three apertures were too far apart to give
a reliable average parameter value.

trend

Consecutive values that increase or decrease gradually.

UMALS
Upper Median Angle Light Scatter

Uncorrected WBC (UWBC)

Uncorrected WBC, labeled “UWBC” is measured directly using the Coulter Principle. UWBC
cannot be edited.

un-interruptible power supply (UPS)

A device with a battery that allows limited continued operation of an instrument or other device
during a power outage.

upload

Data transmitted from a clinical instrument to an LIS system or other host.

user interface

The display and mechanical devices (keyboard, mouse) used by an operator to interact with the
instrument or instruments.

VCSn

Measurements collected for a cell as it passes through the MTM. It consists of values for volume,
conductivity, and light scatter for multiple angles.

629743AE Glossary-29
Glossary

validated

The test results have been automatically or manually reviewed and confirmed according to
laboratory protocols.

WHP
WBC/Hgb/Plt
warning

A fault condition classification for events occurring on the DxH 800 System. A warning occurs
when a condition exists on the system for which the operator needs to be alerted. This condition
has no immediate effect on the system operation, however an action may be needed in order to
avoid problems in the future. The system alerts the operator by displaying messages, triggering
visible alarms and, if applicable, triggering audible alarms. If the warning could eventually
impact the instrument’s operation, then an operational status indicator for the instrument is
triggered. Messages related to the event will be posted to the Event Log by filter category. All
warning require acknowledgement/review; however, how each one is acknowledged or
reviewed is specific to the individual event.
warning message

A classification of messages that are put into the Event Log. Indicates that messages posted to
the Event Log are intended to alert the operator of a warning. Warning messages will be posted
to the Event Log for the General category filter only. The operator must acknowledge/review
the messages in order to clear the Event Log visual indicator.

WBC (White Blood Cell)


White Blood Cell count results from the CBC analysis. The WBC count is adjusted for interfering
substances when appropriate. No further correction of WBC is required.

WBC differential
A determination of the types and numbers of leukocytes found in a blood specimen. This may
be accomplished by the instrument or by examination of a stained blood smear.

white blood cell (leukocyte)


Blood cells that defend the body against disease.

worklist

A listing of specimen analysis status.

XB

Bull’s Moving Average. A quality control mechanism used by hematology instruments that
monitors the stability of the instrument by using the red cell indices MCV, MCH and MCHC.
XB batch

A set of XB results for up to 20 runs, and the associated XB statistics if there are any.

Glossary-30 629743AE
Glossary

XB current batch

The batch of 20 XB results into which results are currently being placed. The batch will remain
the current batch until the first specimen after this batch is run, at which time it will become
the last XB batch.

XB last batch
The last XB batch for which results are available, immediately preceding the current XB batch.

XB previous batch

The XB batch immediately preceding the last XB batch.


XB results

The parameter results (for example, MCH, MCHC) that have been incorporated into an XB batch.

XB run

A single analysis of a specimen, the results for which are used as XB results. The run also has ID
information associated with it in addition to the results.

XB statistics

Statistics resulting from the analysis of results in an XB batch, or in a set of XB batches.


XM

Moving Average. A quality control method that uses the Exponentially Weighted Moving
Average (EWMA) to monitor the stability of the instrument using the CBC, Diff, and Retic
parameters.

XM batch

A set of XM results, configured between two to 1,000 runs, and the associated XM statistics, if
any.

XM batch mean

The average value calculated for the batch of XM results.


XM current batch

The batch of XM results, configured between two to 1000 runs, into which results are currently
being placed. The batch remains the current batch until the first specimen after this batch is
run, at which time it will become an XM completed batch.

XM completed batch

The XM batch for which the maximum number of runs for the batch are available.

XM group

The group (CBC, Diff, Retic and Retic Calc) into which results are placed for XM analysis.

629743AE Glossary-31
Glossary

XM results

The parameter results that have been incorporated into an XM batch.

XM run

A single analysis of a specimen, the results for which are used as XM results. The run also has ID
information associated with it in addition to the results.

XM statistics

Statistics resulting from the analysis of results in an XM batch, or in a set of XM batches.

Glossary-32 629743AE
References

1. Kjeldsberg C, Knight J. Body Fluids: Laboratory Examination of Cerebrospinal, Seminal, Serous &
Synovial Fluids. 3rd Ed., ASCP Press, Chicago, IL 1993.
2. Miale JB, Laboratory Medicine - Hematology. 3rd Edition 1967, CV Mosby, pages 592-595
3. Steele R, Marmer D, O’Brien M, Tyson S, Steele C. Leukocyte survival in cerebrospinal fluid. J Clin
Micro, 198; 23:965-966.
4. Guidelines for the evaluation of blood cell analyzers including those used for differential
leucocyte and reticulocyte counting and cell marker applications. International Council for
Standardization in Haematology: prepared by the ICSH expert panel on cytometry. Clin Lab
Haematol, 16(2):157-174, 1994.
5. Coulter WH. High speed automatic blood cell counter and cell size analyzer. Paper presented
at National Electronics Conference, Chicago, IL, 1956; October 3.
6. Brecher G, Schneiderman M and Williams GZ. Evaluation of electronic red blood cell counter.
AM J Clin path, 1956; 26:1439-1449.
7. Brittin GM, Brecher G and Johnson CA. Evaluation of the COULTER COUNTER Model S. Am J Clin
Path, 1969,; 679-689.
8. Gottman AW. Multiple hematologic analyses by means of a COULTER COUNTER Model S. Paper
presented at International Symposium of Standardization of Hematological Methods,
Fondazione, Carlo Erba, Milan, Italy, November 9 and 10. 1970. Symposium proceedings
published in Haematologica Latina, 1969.
9. Hamilton PJ and Davidson RL. The interrelationships and stability of Coulter S-determined
blood indices. J Clin Path, 1973; 26:700-705.
10. Bessman JD and Johnson RK. Erythrocyte volume distribution in normal and abnormal subjects.
Blood, 1975; 46(3): 369-379.
11. Price-Jones C. The diameters of red cells in pernicious anaemia and in anaemia following
haemorrhage. J Path Bact, 1922; 25:487-504.
12. England JM, Walford DM and Waters DAW. Re-assessment of the reliability of the haematocrit.
Brit J Haemat, 1972; 23:247-256.
13. Bull BS, Scheiderman MA and Brecher G. Platelet counts with the COULTER COUNTER. Am J Clin
Path, 1965; 44(6):678-688.
14. Mundschenk DD, Connelly DP, White JG and Brunning RD. An improved technique for the
electronic measurement of platelet size and shape. J lab clin Med, 1976; 88(2):301-315.
15. Schultz J and Thom R. Electrical sizing and counting of platelets in whole blood. Med Biol Engr,
1973; 73:447-454.
16. Von Behrens WE. Mediterranean macrothrombocytopenia. Blood, 1975; 46(2):199-208.
17. Paulus JM. Platelet size in man. Blood, 1975; 469(3):321-336.
18. Eckhoff RF. An experimental indication of the volume proportional response of the Coulter
Counter for irregularly shaped particles. J Sci Inst, 1967; 44:648-649.
19. Grover NB, Naaman J, Ben-asson S and Dojanski F. Electrical sizing of particles in suspension III.
Rigid spheroids and red blood cells. Biophys J, 1972; 12:1099-1116.

629743AE References-1
References

20. Waterman CS, Atkinson EE, Wilkins B, Fischer CL and Kimsey SL. Improved measurement of
erythrocyte volume distribution by aperture-counter signal analysis. Clin Chem, 1975; 21:1201-
1211.
21. Kachel V and Ruhenstroth-Bauer G. Methodik and Ergebissne Optiseher Formfatorunter-
suchungen bei der Zellvolumenmessung nach Coulter. Micros Acta, 1976; 75:419-423.
22. Gauthier J, Harel P, Belanger C and Fraysse J. Human leukocytes: their size distribution and
mean corpuscular volume. Can med Assoc J, 1967; 97:793-796.
23. Hughes-Jones NC, England JM, Norley I and Young JMS. Differential leucocyte counts by volume
distribution analysis. Brit J Haemat, 1974; 28(1):148.
24. England JM, Bashford CC, Hewer MG, Hughes-Jines NC and Down MC. A semi-automatic
instrument for estimating the differential leucocyte count. Biomed Engr, 1975; 10(8):303-304.
25. Wycherly PA and O’Shea MJ. Abridged differential leucocyte counts provided by a Coulter
Channelyzer in a routine haematology laboratory. J Clin Path, 1978.
26. Oberjat TE, Zucker TM and Cassen B. Rapid and reliable differential counts on dilute leukocyte
suspensions. J Lab Clin Med, 1970; 76(3):518-522.
27. Hoffman RA and Britt WB. Flow-system measurement of cell impedance properties. J
Histochem Cytochem, 1979; 27(1):234-240.
28. Leif RC, Scwartz S, Rodriguez CM, Peel-Fernandez L, Groves M, Leif SB, Cayer M and Crews H.
Two-dimensional impedance studies of BSA buoyant density separated human erythrocytes.
Cytometry, 1985; 6(1):13-21.
29. Coulter WH et al. Signal modulated apparatus for generating and detecting resistive and
reactive changes in a modulated current path for particle classification and analysis. US Patent
3,502,974, March24, 1970.
30. Fulwyler MJ. Electronic separation of biological cells by volume. Science, 1965; 150:910-911.
31. Loken MR, Sweet RG and Herzenberg LA. Cell discrimination by multiangle light scattering. J
Histochem Cytochem, 1976; 24(1):284-291.
32. Jovin TM, Morris SJ, Striker G, Schultens HA, Digweed M and Arndt-Jovin DJ. Automatic sizing
and separation of particles by ratios of light scattering intensities. J Histochem Cytochem, 1976;
24(1):269-283.
33. Miale JB. Laboratory Medicine: Hematology. CV Mosby Company, St. Louis, MO, 4th ed., 1972; 22.
34. Corash L. Rheinschmidt M, Lieu S, Meers P and Brew E. Fluorescence-activated flow cytometry
in the hematology clinical laboratory. Cytometry, 1988; Supplement 3:60-64.
35. Friedman EW. Reticulocyte counts: How to use them, what they mean. Diagnostic Medicine,
1984; 7(6):29-33.
36. Williams WJ, Beutler E, Ersley AJ, and Lichtman MA. Hematology. McGraw-Hill, Inc, New York,
NY, 4th ed., 1990; 416.
37. Brecher G. New methylene blue as a reticulocyte stain. Am J Clin Path, 1949; 19:895-896.
38. International Committe for Standardization in Haematology. Recommendations for reference
method for haemoglobinometry in human blood (ICSH Standard EP 6/2: 1977) and
specifications for international haemiglobincyanide reference preparation (ICSH Standard EP
6/3: 1977). J Clin Path, 1978; 31(2):1390143.
39. Dorsey DB. What can quality control do for hematology? Am J Med Tech, 1965; Mar-Apr:150-153.

References-2 629743AE
References

40. Bull BS. A statistical approach to quality control. Quality Control in Hematology. Symposium of
the International Committee for Standardization in Haematology. Lewis SM and Coster JF, eds,
Academic Press, London, England, 1975.
41. Koepke JA and Protextor TJ. Quality assurance for multichannel hematology instruments. Am J
Clin Path, 1981; 75(1):28-33.
42. Bull BS. A statistical approach to quality control. Quality Control in Hematology, Symposium of
the International Committee for Standardization in Haematology. Lewis SM and Coster JF, eds,
Academic Press, London, England, 1975.
43. Bowles K.M., Cook L.J., Richards E.M., Baglin T.P, Platelet size has diagnostic predictive value in
patients with thrombocytopenia, Clin. Lab Haem. 27:370–373, 2005.
44. Bancroft A. J., Abel E. W., Mclaern M. . Belch J. J. F. , Mean platelet volume is a useful parameter:
a reproducible routine method using a modified Coulter Thrombocytomer, Platelets 11:379–387,
2005.

629743AE References-3
References

References-4 629743AE
Index

A An invalid object type was parsed., 10-73


A control has failed. Auto Stop is not An invalid primary ID was received., 10-73
enabled., 10-92 An invalid secondary ID was received., 10-73
A control has failed. Auto Stop triggered., 10-72 An unknown attribute was encountered while
A matching patient specimen was found. Studies parsing object., 10-92
mode is enabled., 10-72 An XML parser warning has occurred., 10-92
A NULL or empty XML string was received for An XML parsing error occurred., 10-73
parsing., 10-72 An XML parsing error occurred: empty attribute
A report could not be generated: No data source set for object., 10-73
found., 10-99 An XML parsing error occurred: invalid attribute
A report could not be generated: Required sub- value., 10-73
report not found., 10-99 An XML parsing error: unknown start tag in
A/D or MRC reference voltage exceeded the object., 10-92
operating limits., 10-43 An XML parsing warning: unknown end tag in
A/D or MRC reference voltage is approaching object., 10-92
the operating limits., 10-43 Anticoagulant, 1-32
A/D resource busy., 10-72 Application exited while backup was in
A/D resource insufficient pairs., 10-72 progress., 10-92
A/D resource not monitoring., 10-73 Aspiration, 1-32
A/D resource not ready., 10-73 Aspiration error., 10-43
A/D resource timeout., 10-73 Aspiration syringe pump did not sense
Accuracy, 1-33 home., 10-44
Acoustic Noise Level, 1-29 Aspiration syringe pump move could not be
Adding verified., 10-44
Flagging Limits, 9-35 Aspiration syringe pump sensed home after
Locations, 9-62 successful recovery., 10-45
Physicians, 9-61 Attempt to acknowledge results receipt
Adding a Test Order, 5-6 failed., 10-73
Automatic Upload from LIS, 5-6 Attempt to perform auto stop failed., 10-74
Manual Entry, 5-6 Attempt to retrieve audible alarm setting
Alarms failed., 10-74
Setup, 9-14 Attempt to retrieve SPM configuration
Alert Status Icons, 1-22 failed., 10-74
Ambient temperature exceeded the operating Auto Print, 9-92
limits., 10-41 Auto report generation error., 10-99
Ambient temperature is approaching the Auto Stop
operating limits., 10-43 Setup, 9-63
An invalid collation ID was received from the Auto Stop triggered, an SPM has been taken
System Manager., 10-73 offline., 10-74

Index-1
Index

B Group contains undefined parameter., 10-80


Background Counts, 1-40 Inconsistent database object., 10-81
Backup and Recovery Invalid flag received., 10-82
Setup, 9-7 Laboratory initialization: no operating limits
Backup operation failed., 10-92 defined., 10-83
Bar-code Labels, 1-27 Missing parameter group definition for
Bar-code Read Rate Procedure, 10-27 parameter., 10-85
Bar-code Reader Alignment Procedure, 10-28 Operating limit changed for test
Bar-code reader did not read specified parameter., 10-86
label., 10-45 Panel contains undefined parameter., 10-86
Barcode Reader setting up failed, 10-74 Parameter deleted., 10-87
Batching, 5-19 The control lot you are running has
BCI Control Setup expired., 10-98
From Bar Code, 9-87
Blood detector reading exceeded the operating C
limits., 10-45 Calibration, 11-1
Blood detector reading is approaching the With S-Cal, 11-2
operating limits., 10-41 With Whole Blood, 11-5
Blood detector variance readings exceeded the Calibrators
operating limits., 10-46 Recommended, 1-26
BSV position could not be verified., 10-45 CAN bus impedance not terminated properly for %1
BUSMODEL module MRC (Host ID: %2), 10-74
A control has failed. Auto Stop is not CAN bus impedance not terminated properly for %1
enabled., 10-92 MRC (Host ID: %2)., 10-74
A control has failed. Auto Stop triggered., 10-72 Cannot find system path in the system
Auto Stop triggered, an SPM has been taken registry., 10-75
offline., 10-74 Cannot load language library for module., 10-75
Cannot process QC specimen., 10-92 Cannot move the cassette into or out of the mix
Conflicting decision rules found., 10-92 station. OPERATOR MUST VERIFY
Conflicting decision rules were TRANSPORT AREA IS CLEAR OF
disabled., 10-92 CASSETTES., 10-35
Could not determine unique specimen Cannot process QC specimen., 10-92
order., 10-75 Carryover, 1-39, 11-11
Database item validation error., 10-76 Cassette
Error formatting test values., 10-76 Cleaning, 5-4, 12-27
Failed to add test., 10-77 Handling, 5-4
Failed to add/remove a panel. Exception Loading, 5-4
occurred., 10-77 Type D, 1-27
Failed to add/remove panel. Mismatched fluid Cassette did not engage the mixer wall.
types., 10-78 OPERATOR MUST VERIFY TRANSPORT
Failed to add/remove panel. Panel not AREA IS CLEAR OF CASSETTES., 10-35
available., 10-78 Cassette mixer did not sense home., 10-35
Failed to add/remove panel. The panel was Cassette mixer missed steps while
already in progress., 10-78 mixing., 10-36
Failed to add/remove panel. Unsupported or Cassette not sensed on mixer wall during mix
unknown panel type., 10-78 routine., 10-36
Failed to read whole blood limit., 10-79 Cassettes, 1-27
Failed to remove a panel. Panel was not Type A, 1-27
requested in the order., 10-79 Type C, 1-27

Index-2
Index

CBC calibrator lot has expired., 10-92 limits., 10-68


CBC calibrator lot mismatch., 10-99 WBC pump delivery could not be
CBC count vacuum exceeded the operating verified., 10-71
limits., 10-46 WBC pump did not sense home., 10-71
CBC count vacuum is approaching the operating CBC Module unable to proceed., 10-35
limits., 10-41 CBC MRC (Host ID: 10) not responding, 10-74
CBC diluent temperature exceeded the CBC waste chamber drain did not sense
operating limits., 10-46 empty., 10-47
CBC diluent temperature is approaching the Check Pneumatic Supply Procedure, 10-16
operating limits., 10-46 Cleaning
CBC lyse pump delivery could not be Cassettes, 5-4, 12-27
verified., 10-46 When, Why, and How, 12-1
CBC lyse pump did not sense home., 10-47 CLR framework error. Call your Beckman Coulter
CBC Module, 1-11 Representative., 10-74
CBC module Codes, 6-42
CBC count vacuum exceeded the operating Comments
limits., 10-46 Setup, 9-57
CBC count vacuum is approaching the Common Services, 1-11
operating limits., 10-41 Common Services unable to proceed., 10-36
CBC diluent temperature exceeded the Communication timeout with SPM Module ID/
operating limits., 10-46 Audio board., 10-75
CBC diluent temperature is approaching the Conflicting decision rules found., 10-92
operating limits., 10-46 Conflicting decision rules were disabled., 10-92
CBC lyse pump delivery could not be Control Run
verified., 10-46 Details, 4-11
CBC lyse pump did not sense home., 10-47 Control specimen not processed., 10-93
CBC Module unable to proceed., 10-35 Controls
CBC waste chamber drain did not sense Recommended, 1-26
empty., 10-47 Correct XML parser not installed., 10-75
Hgb blank exceeded the operating Could not determine unique specimen order., 10-75
limits., 10-53 Could not move cassette into or out of pending
Hgb blank is approaching the operating buffer. OPERATOR MUST VERIFY
limits., 10-54 TRANSPORT AREA IS CLEAR OF
RBC or WBC aperture voltage exceeded the CASSETTES., 10-36
air limits., 10-63 Could not move cassette out of the input buffer.
RBC or WBC aperture voltage exceeded the OPERATOR MUST VERIFY TRANSPORT
clog limits., 10-63 AREA IS CLEAR OF CASSETTES., 10-36
RBC or WBC reference voltage exceeded the Could not move the cassette into or out of the
operating limits., 10-64 output buffer., 10-37
RBC or WBC reference voltage is Could not read specimen bar code., 10-75
approaching the operating limits., 10-64 Could not read specimen ID or cassette bar
RBC or WBC ZAP voltage exceeded the codes., 10-75
operating limits., 10-62 Could not start maintenance procedure., 10-75
RBC or WBC ZAP voltage is approaching the COULTER Body Fluid Control, 1-26
operating limits., 10-63 COULTER LATRON CP-X Control, 1-26
RBC pump delivery could not be Coulter Method, 2-2
verified., 10-64 Coulter Principle, 2-1
RBC pump did not sense home., 10-64 COULTER S-Cal Calibrator, 1-26
Two or more CBC apertures had one or more CSM module
parameters that exceeded the operating Ambient temperature exceeded the

Index-3
Index

operating limits., 10-41 Expected database object not found., 10-77


Ambient temperature is approaching the Database query error., 10-76
operating limits., 10-43 Date and Time
Common Services unable to proceed., 10-36 Setup, 9-11
Electronic Supply module current exceeded DC or RF flow cell voltage exceeded the
the operating limits., 10-49 operating limits., 10-47
Electronic Supply module current is DC or RF flow cell voltage is approaching the
approaching the operating limits., 10-50 operating limits., 10-47
Electronic Supply module in service Decision Rules
mode., 10-50 Setup, 9-40
Electronic Supply module voltage exceeded Default order contained an invalid test., 10-76
the operating limits., 10-51 Default Test Order, 5-8, 9-107
Electronic Supply module voltage is Delta Checks
approaching the operating limits., 10-52 Setup, 9-34
Pneumatic Supply module exceeded the Diagnostic Procedures
operating limits., 10-57 Bar-code Read Rate, 10-27
Pneumatic Supply module is approaching Bar-code Reader Alignment, 10-28
the operating limits., 10-58 Check Pneumatic Supply, 10-16
Reagent Services hardware failure., 10-64 Cycle DV, 10-24
Unable to read waste status., 10-68 Dispense Diluent, 10-23
Vacuum chamber detected liquid., 10-71 Flush Flow Cell, 10-26
Vacuum chamber drain did not sense HgB Blank Verification, 10-15
empty., 10-40 Prime Sweep Flow, 10-24
Vacuum chamber overflow detected., 10-40 Unlock DV, 10-25
Vent/overflow chamber detected Verify Blood Detectors, 10-25
overflow., 10-40 ZAP Aperture, 10-14
Vent/overflow chamber drain did not sense Diagnostics Procedures, 10-6
empty., 10-40 Diff lyse pump delivery could not be
Cycle DV Procedure, 10-24 verified., 10-47
Diff lyse pump did not sense home., 10-48
Diff preservative pump delivery could not be
D verified., 10-48
Daily Checks, 3-1 Diff preservative pump did not sense
NRBC, 3-5 home., 10-48
Reviewing, 3-7 Diluent source switched., 10-93
Running, 3-2 Disconnected expansion board for %1 MRC (Host
Daily Checks procedure incomplete., 10-75 ID: %2)., 10-76
Daily Shutdown, 8-2 Dispense Diluent Procedure, 10-23
Data stored on SPM Module ID/Audio board Disposal of Electrical Instrumentation, 10-4
EEPROM is corrupt., 10-76 Distribution valve did not report expected
Data summary Daily Checks: unknown position., 10-48
parameter., 10-99 Distribution valve did not sense home., 10-48
Database Cleanup Distribution valve home recovered., 10-48
Setup, 9-8 Distribution valve recovered expected
Database error., 10-76 position., 10-49
Database item validation error., 10-76 DMREDUCE module
DATABASE module Barcode Reader setting up failed, 10-74
Database error., 10-76 No test order found to process results., 10-86
Database query error., 10-76 Writing to barcode reader failed., 10-91
Error initializing database., 10-77

Index-4
Index

DMSERVICE module Electronic Supply module voltage exceeded the


Control specimen not processed., 10-93 operating limits., 10-51
Multiple conflicting result values produced for Electronic Supply module voltage is
a specimen., 10-85 approaching the operating limits., 10-52
No values supplied for report job., 10-86 Empty parameter definitions received., 10-76
Timeout during processing of System Manager Empty test panel definitions received., 10-76
message., 10-89 Error creating window., 10-76
Timeout waiting for shift information Error formatting test values., 10-76
retrieval., 10-90 Error initializing database., 10-77
Timeout waiting for unit conversion., 10-90 Error loading language text., 10-77
DMUI module Event descriptor not found., 10-77
Application exited while backup was in Event Messages, 10-34
progress., 10-92 EVENTS module
Backup operation failed., 10-92 Event descriptor not found., 10-77
Data summary Daily Checks: unknown Failed reading Events Expiration Rules XML
parameter., 10-99 file., 10-77
Error creating window., 10-76 Exception during results processing., 10-77
Error loading language text., 10-77 Expansion ports communication error for %1 MRC
Failed reading data while trying to save to (Host ID: %2), 10-77
file., 10-99 Expected database object not found., 10-77
Failed to parse Worklist filter XML file., 10-79 Extended QC Setup, 9-90
Failed to read from the recovery Additional Comment, 9-91
configuration., 10-79
Manual backup operation failed., 10-106
Operator ID was skipped when restoring F
configuration., 10-96 Failed reading data while trying to save to
Restore attempt failed., 10-88 file., 10-99
Scheduled backup not performed., 10-97 Failed reading Events Expiration Rules XML
System backup not performed. SPM was file., 10-77
busy., 10-98 Failed to add data to report job. Report job
System unexpectedly exited while backup cancelled., 10-99
was in progress., 10-98 Failed to add test., 10-77
Unexpected framework error. Call your Failed to add/remove a panel. Exception
Beckman Coulter Representative., 10-90 occurred., 10-77
Download received while batching is Failed to add/remove panel. Mismatched fluid
enabled., 10-93 types., 10-78
Duplicate specimen ID., 10-76 Failed to add/remove panel. Panel not
DxH Cell Lyse, 1-25 available., 10-78
DxH Cleaner, 1-25 Failed to add/remove panel. The panel was already
DxH Diff Pack, 1-25 in progress., 10-78
DxH Retic Pack, 1-25 Failed to add/remove panel. Unsupported or
unknown panel type., 10-78
Failed to complete result calculations., 10-78
E Failed to connect to System Manager., 10-78, 10-79
Electronic Supply module current exceeded the Failed to parse Worklist filter XML file., 10-79
operating limits., 10-49 Failed to process report., 10-99
Electronic Supply module current is Failed to read from the recovery
approaching the operating limits., 10-50 configuration., 10-79
Electronic Supply module in service Failed to read IQAP definition file., 10-79
mode., 10-50 Failed to read whole blood limit., 10-79

Index-5
Index

Failed to remove a panel. Panel was not requested Handling Alarms, 5-19
in the order., 10-79 Hardware
Failed to restore configuration information., 10-79 Overview, 1-4
Failed to retrieve bar-code configuration., 10-79 Specimen Transport Module, 1-8
Failed to retrieve batch mode., 10-79 Hgb blank exceeded the operating limits., 10-53
Failed to retrieve configuration information., 10-79 Hgb blank is approaching the operating
Failed to retrieve enabled parameters., 10-80 limits., 10-54
Failed to retrieve parameter definitions., 10-80 HGB Blank Verification Procedure, 10-15
Failed to retrieve report information., 10-80 Home Screen, 1-18
Failed to retrieve test panel definitions., 10-80 Host data error (Patient record). Invalid data for
Failed to save database information., 10-80 patient with ID: %1, 10-99
File exception error., 10-80 Host data error (Patient record). Invalid patient
Flagging and Rules ID., 10-99
Setup, 9-33 Host data error (Test Order record)., 10-100
Flagging Limits, 9-35 Host data error (Test Order record). Invalid data
Adding, 9-35 for test order: %1., 10-100
Flagging Sensitivity, 9-39 Host data error (Test Order record): invalid data
Flags, 6-41 in required field., 10-100
Setup, 9-33 Host data error: cannot create new test
Floor Stand, 1-12 order., 10-100
Flow Cell Host data error: comment not associated with
Volume and Conductivity, 2-9 patient demographics., 10-100
Flow cell DC voltage exceeded the expected Host data error: comment not associated with
range. Possible full clog., 10-52 specimen., 10-100
Flow-cell clog., 10-93 Host data error: duplicate tests cannot be
Flush Flow Cell Procedure, 10-26 added., 10-100
Host data error: Invalid data received in
Comment record., 10-100
G Host data error: invalid data received in Header
GENERIC module record., 10-100
Cannot find system path in the system Host data error: missing primary
registry., 10-75 identifier., 10-100
Cannot load language library for Host data error: specimen ID is reserved for
module., 10-75 control ID., 10-101
CLR framework error. Call your Beckman Host data error: specimen type cannot be
Coulter Representative., 10-74 changed., 10-101
File exception error., 10-80 Host data error: specimen type cannot be
Language prefix error., 10-83 modified., 10-101
Load library failed., 10-83 Host data error: specimen type not
MFC exception occurred., 10-83 supported., 10-101
OLE disptatch error., 10-86 Host data error: test panel(s) not supported or
OLE error., 10-86 enabled., 10-101
SEH (kernel) exception., 10-88 Host data error: tests not added., 10-101
Group contains undefined parameter., 10-80 Host data error: tests not canceled., 10-102
Host data error: tests not consistent with
H specimen type., 10-102
Host data error: transmitted patient ID is
Handheld Scanner
different., 10-102
Cleaning, 12-28
Host error: serial port properties not
Using, 5-18

Index-6
Index

applied., 10-80 Input buffer pushers did not sense home., 10-41
Host error: transmission to LIS failed., 10-80 Input buffer pushers missed steps during a
Host parsing error (Header record): record sweep., 10-55
length invalid., 10-102 Installation Category, 1-29
Host parsing error: character missing., 10-102 Intended Use
Host parsing error: character missing., 10-103 System, 1-1
Host parsing error: pair missing., 10-102 Inter-Unit Section, 1-4
Host parsing error: / character missing., 10-103 Introduction, xxxi
Host parsing error: field delimiter Invalid bar-code format for specimen ID label
missing., 10-104 [I2of5] digits., 10-81
Host parsing error: Header record missing in LIS Invalid CDATA element in report job result
message., 10-103 value., 10-105
Host parsing error: Header record out of Invalid CDATA elements were found in a report
sequence in LIS message., 10-103 job., 10-105
Host parsing error: incorrect CRC., 10-104 Invalid collation ID., 10-82
Host parsing error: invalid escape Invalid data for report job., 10-105
sequence., 10-104 Invalid data set used in report job., 10-106
Host parsing error: invalid sequence Invalid event log message from System
number., 10-104, 10-105 Manager., 10-82
Host parsing error: missing component Invalid flag received., 10-82
delimiter., 10-105 Invalid IQAP definitions read., 10-81
Host parsing error: Patient record missing in LIS Invalid label found on a control specimen., 10-82
message., 10-103 Invalid log on to System Manager., 10-106
Host parsing error: record terminator character Invalid or missing report file for report
missing., 10-105 job., 10-106
Host parsing error: record type not Invalid parameter group definitions., 10-82
supported., 10-105 Invalid parameter received from System
Host parsing error: start of text character Manager., 10-82
missing., 10-105 Invalid parameter result generated by the System
Host parsing error: terminator character Manager algorithm., 10-82
missing., 10-105 Invalid report request received from System
Host parsing error: Terminator record missing Manager., 10-106
in LIS message., 10-103 Invalid reuse of specimen ID., 10-82
Invalid specimen type in default order., 10-82
Invalid state reported for liquid detector
I sensor., 10-82
Icons and Navigation/Status Buttons, 1-21 Invalid vector result sent for parameter., 10-83
Incompatible presentation mode for control IQAP Export, 9-93
specimen., 10-95 IQAP export cancelled: system restart., 10-93
Incompatible presentation mode for IQAP export failed: duplicate transaction., 10-94
specimen., 10-95 IQAP export failed: not enrolled in RMS., 10-94
Incompatible specimen type for label order., 10-80 IQAP export failed: RMS service not
Incompatible specimen type in default available., 10-94
order., 10-81 IQAP export failed: RMS transfer not
Inconsistent database object., 10-81 completed., 10-94
Incorrect number of specimens detected during IQAP export failed: system error., 10-94
Carryover procedure., 10-81
Incorrect specimen type detected during Carryover
procedure., 10-81 L
Initial Aspiration error., 10-54 Label order contained an invalid test., 10-83

Index-7
Index

Laboratory initialization: no operating limits Host data error: tests not added., 10-101
defined., 10-83 Host data error: tests not canceled., 10-102
Language prefix error., 10-83 Host data error: tests not consistent with
Laser specimen type., 10-102
Safety, 10-1 Host data error: transmitted patient ID is
Warning Labels, 10-2 different., 10-102
Light Scatter Host error: serial port properties not
Measurement, 2-9 applied., 10-80
Light scatter offset exceeded the operating Host error: transmission to LIS failed., 10-80
limits., 10-55 Host parsing error (Header record): record
Light scatter offset is approaching the length invalid., 10-102
operating limits., 10-55 Host parsing error: character
Lin-X Linearity Control, 1-26 missing., 10-102
LIS module Host parsing error: character
Download received while batching is missing., 10-103
enabled., 10-93 Host parsing error: pair missing., 10-102
Host data error (Patient record). Invalid data Host parsing error: / character
for patient with ID: %1, 10-99 missing., 10-103
Host data error (Patient record). Invalid Host parsing error: field delimiter
patient ID., 10-99 missing., 10-104
Host data error (Test Order record)., 10-100 Host parsing error: Header record missing in
Host data error (Test Order record). Invalid LIS message., 10-103
data for test order: %1., 10-100 Host parsing error: Header record out of
Host data error (Test Order record): invalid sequence in LIS message., 10-103
data in required field., 10-100 Host parsing error: incorrect CRC., 10-104
Host data error: cannot create new test Host parsing error: invalid escape
order., 10-100 sequence., 10-104
Host data error: comment not associated Host parsing error: invalid sequence
with patient demographics., 10-100 number., 10-104, 10-105
Host data error: comment not associated Host parsing error: missing component
with specimen., 10-100 delimiter., 10-105
Host data error: duplicate tests cannot be Host parsing error: Patient record missing in
added., 10-100 LIS message., 10-103
Host data error: Invalid data received in Host parsing error: record terminator
Comment record., 10-100 character missing., 10-105
Host data error: invalid data received in Host parsing error: record type not
Header record., 10-100 supported., 10-105
Host data error: missing primary Host parsing error: start of text character
identifier., 10-100 missing., 10-105
Host data error: specimen ID is reserved for Host parsing error: terminator character
control ID., 10-101 missing., 10-105
Host data error: specimen type cannot be Host parsing error: Terminator record
changed., 10-101 missing in LIS message., 10-103
Host data error: specimen type cannot be Required parameter for generating dataplots
modified., 10-101 missing., 10-87
Host data error: specimen type not Load library failed., 10-83
supported., 10-101 Loading Cassettes, 5-4
Host data error: test panel(s) not supported Logging On
or enabled., 10-101 System Manager, 3-1

Index-8
Index

M Missing parameter group definition for


Manual backup operation failed., 10-106 parameter., 10-85
Manuals Mix pressure exceeded the operating
Updating, iii, iv, BACK-1 limits., 10-55
Material Safety Data Sheets, 1-26 Mix pressure is approaching the operating
Maximum number of consecutive CBC module limits., 10-56
errors reached., 10-84 Motor encoder reported missed steps., 10-85
Maximum number of consecutive CSM errors Motor move to sensor timeout., 10-85
reached., 10-84 MSDS, 1-26
Maximum number of consecutive Diff errors MTM, 2-8
reached., 10-84 Multi Transducer Module, 2-8
Maximum number of consecutive duplicate Multiple conflicting result values produced for a
specimen IDs reached., 10-85 specimen., 10-85
Maximum number of consecutive NRBC errors
reached., 10-84 N
Maximum number of consecutive partial No pending tests found for specimen., 10-85
voteouts reached., 10-96 No test order and no default order defined., 10-85
Maximum number of consecutive Retic errors No test order could be generated., 10-85
reached., 10-85 No test order defined for batch processing., 10-86
Maximum number of consecutive SAM errors No test order found to process results., 10-86
reached., 10-85 No values supplied for report job., 10-86
Maximum number of No Match events None module
reached., 10-95 An invalid object type was parsed., 10-73
Maximum number of No Match events Attempt to retrieve SPM configuration
reached., 10-83 failed., 10-74
Maximum number of No Read events NRBC lyse pump delivery could not be
reached., 10-95 verified., 10-56
Maximum number of No Read events NRBC lyse pump did not sense home., 10-56
reached., 10-84
Maximum number of Partial Aspiration events
reached., 10-96 O
Maximum number of Partial Aspiration events Object meta type incorrect., 10-86
reached., 10-84 OLE disptatch error., 10-86
Maximum number of specimen mismatches OLE error., 10-86
reached., 10-85 One or more Flow cell parameters exceeded
Maximum number of Total Voteout events operating limits., 10-56
reached., 10-96 Operating limit changed for test parameter., 10-86
Maximum number of Total Voteout events Operating position of STM could not be
reached., 10-84 verified., 10-37
Measuring and Operating Ranges, 1-37 Operation Principles, 2-1
Menu Bar, 1-19 CBC Analysis, 2-4
Messages Coincidence Correction, 2-6
Appearing with Results, 6-43 Counting and Sizing, 2-6
Definitive, 6-47 Detection and Sensing, 2-5
Status, 6-49 Hemoglobinometry, 2-7
Suspect, 6-43 Histogram Development, 2-7
System, 6-44 Pulse Editing, 2-5
Method History, 2-1 Specimen Preparation, 2-4
MFC exception occurred., 10-83 Sweep Flow, 2-5

Index-9
Index

Voting, 2-6 Prime procedure was not successful., 10-96


Dataplot Development, 2-11 Prime Sweep Flow Procedure, 10-24
Differential Analysis Printer
Conductivity Analysis, 2-2 Setup, 9-10
Light Scatter Analysis, 2-3 Printing error: out of paper., 10-106
Volume Analysis, 2-2 Probe clean valve is not operating
VCSn properly., 10-59
Detection and Sensing, 2-8 Probe cleaning pump delivery could not be
Sample Preparation, 2-8 verified., 10-59
Operator ID was skipped when restoring Probe cleaning pump did not sense home., 10-59
configuration., 10-96 Probe vertical drive did not sense home., 10-60
Output buffer is full., 10-42 Probe vertical drive move could not be
verified., 10-60
Probe vertical drive sensed home after
P successful recovery., 10-61
Panel contains undefined parameter., 10-86 Probe waste chamber vacuum error
Parameter deleted., 10-87 recovered., 10-61
Parameter Measurement, Derivation, and Probe waste chamber vacuum exceeded the
Calculation, 2-14 operating limits., 10-62
Parameters Probe waste drain did not sense empty., 10-62
System, 1-2 Processed specimen was not removed on
Patient Control time., 10-96
New, 9-85
Patient Results, 6-17
Additional Data, 6-22 Q
Dynamic Mode, 6-19 Quality Control
Histogram/Dataplot Overview, 4-1
Description, 6-21 Setup
History, 6-37 Extended QC, 9-90
Navigation, 6-33 View Control Files, 4-3
Quick Search Mode, 6-20
Reflex, 6-36
Reject, 6-51 R
Release, 6-51 Radiation Statement, 10-1
Rerun, 6-37 RBC or WBC aperture voltage exceeded the air
Static Mode, 6-20 limits., 10-63
Performance, 1-32 RBC or WBC aperture voltage exceeded the clog
Persistent object not found., 10-87 limits., 10-63
Pneumatic Supply, 1-12 RBC or WBC reference voltage exceeded the
Pneumatic Supply module exceeded the operating limits., 10-64
operating limits., 10-57 RBC or WBC reference voltage is approaching
Pneumatic Supply module is approaching the the operating limits., 10-64
operating limits., 10-58 RBC or WBC ZAP voltage exceeded the
Polution Degree, 1-29 operating limits., 10-62
Possible tube bottom detected before RBC or WBC ZAP voltage is approaching the
expected., 10-58 operating limits., 10-63
Power RBC pump delivery could not be verified., 10-64
Consumption, 1-28 RBC pump did not sense home., 10-64
Input, 1-28 Reagent is depleted., 10-87
Precautions and Hazards, 10-1 Reagent is low., 10-97

Index-10
Index

Reagent Services hardware failure., 10-64 S


Reagent should be depleted., 10-87 Safety, v
Reagents SAM horizontal drive assembly did not sense
Recommended, 1-25 home., 10-65
Reagents not available., 10-87 SAM horizontal drive assembly move could not
Reference Range Studies, 1-41 be verified., 10-65
Release Rules SAM horizontal drive assembly sensed home
Setup, 9-60 after successful recovery., 10-65
Repeatability, 1-36, 11-7 SAM module
Automatic Presentation, 11-8 Aspiration error., 10-43
Manual Presentation, 11-9 Aspiration syringe pump did not sense
Replacing home., 10-44
When, Why, and How, 13-1 Aspiration syringe pump move could not be
Report data set not defined. Report job creation verified., 10-44
failed., 10-106 Aspiration syringe pump sensed home after
Report failed., 10-106, 10-107 successful recovery., 10-45
REPORTS module Bar-code reader did not read specified
A report could not be generated: No data label., 10-45
source found., 10-99 Blood detector reading exceeded the
A report could not be generated: Required operating limits., 10-45
sub-report not found., 10-99 Blood detector reading is approaching the
Auto report generation error., 10-99 operating limits., 10-41
Failed to add data to report job. Report job Blood detector variance readings exceeded
cancelled., 10-99 the operating limits., 10-46
Printing error: out of paper., 10-106 BSV position could not be verified., 10-45
Report data set not defined. Report job Initial Aspiration error., 10-54
creation failed., 10-106 Possible tube bottom detected before
Report failed., 10-106, 10-107 expected., 10-58
Required parameter for generating dataplots Probe clean valve is not operating
missing., 10-87 properly., 10-59
Rerun secondary ID did not match value in test Probe cleaning pump delivery could not be
order., 10-88 verified., 10-59
Resource concurrent use conflict., 10-88 Probe cleaning pump did not sense
Restart after unrecoverable exception., 10-88 home., 10-59
Restore attempt failed., 10-88 Probe vertical drive did not sense
Retic clear pump delivery could not be home., 10-60
verified., 10-64 Probe vertical drive move could not be
Retic clear pump did not sense home., 10-65 verified., 10-60
Retic stain pump delivery could not be Probe vertical drive sensed home after
verified., 10-65 successful recovery., 10-61
Retic stain pump did not sense home., 10-65 Probe waste chamber vacuum error
Retic-X Cell Control, 1-26 recovered., 10-61
Revision History, iii Probe waste chamber vacuum exceeded the
RS MRC (Host ID: 30) not responding, 10-87 operating limits., 10-62
Rules Triggered, 9-113 Probe waste drain did not sense
Running Samples empty., 10-62
Cassette Presentation, 5-12 SAM horizontal drive assembly did not sense
Single-tube Presentation, 5-15 home., 10-65
SAM horizontal drive assembly move could

Index-11
Index

not be verified., 10-65 Comments, 9-57


SAM horizontal drive assembly sensed home Communications, 9-100
after successful recovery., 10-65 Container Configuration, 9-2
SAM unable to proceed., 10-37 Low Level Condition, 9-3
Stripper vertical drive did not sense Daily Checks, 9-104
home., 10-67 Automatic Cycling, 9-104
Stripper vertical drive sensed home after Decision Rules, 9-40
successful recovery., 10-67 Delta Checks, 9-34
Transport shield was opened., 10-39 Demographics, 9-76
Tube was detected after a successful Flagging and Rules, 9-33
recovery., 10-67 Flagging Sensitivity, 9-39
Tube was detected earlier than Flagging/Rules
expected., 10-67 Collation, 9-64
Tube was not detected., 10-67 Flags, 9-33
SAM MRC (Host ID: 40) not responding., 10-88 Install/Upgrade Software, 9-101
SAM unable to proceed., 10-37 Locations, 9-62
Sample Analysis, 5-1 Operators and Roles, 9-27
Placing Bar-code Label on the Tube, 5-3 Physicians, 9-61
Sample Aspiration Module, 1-10 Quality Assurance, 9-102
Aspiration Probe, 1-10, 1-11 Carryover, 9-102
Bar-code Reader, 1-11 CBC Calibration, 9-102
Blood Detectors, 1-10 QA Auto Report, 9-103
BSV, 1-10 Repeatability, 9-102
Sample Collection, 5-1 Quality Control, 9-83
Sample or sheath pressure exceeded the New Patient, 9-85
operating limits., 10-66 Shifts, 9-98
Sample or sheath pressure is approaching the XB, 9-93
operating limits., 10-66 XM, 9-96
Sample Stability and Storage, 1-45 Release Rules, 9-60
Body Fluids, 1-47 Reporting, 9-65
Predilute, 1-47 Auto Report, 9-70, 9-75
Whole Blood, 1-46 Lab Information, 9-66
Samples Label Names, 9-69
Running Analysis, 5-12 Units Format, 9-67
SAX COM error., 10-88 System, 9-6
Scheduled backup not performed., 10-97 Sheath or sample tank did not indicate full
Scheduled procedure skipped., 10-97, 10-98 condition., 10-66
Search Icon, 1-23 Shutdown
Secondary ID did not match the value in test Daily, 8-2
order., 10-89 Overview, 8-1
SECURITY module SPM, 8-2
Invalid log on to System Manager., 10-106 System Manager, 8-1
SEH (kernel) exception., 10-88 Shutdown procedure incomplete., 10-98
Setup, 9-1 Shutdown procedure incomplete., 10-89
Auto Stop, 9-63 Single tube station home position or tube cradle
Batching Enables, 9-110 status could not be verified., 10-39
BCI Control Single tube station recovered while extending
Manual Entry, 9-87 or retracting., 10-66
BCI Control from Bar Code, 9-87 Single-tube Presentation Icon, 1-21

Index-12
Index

Specimen ID verification failed., 10-89 Single tube station recovered while


Specimen ID verification failure for a extending or retracting., 10-66
specimen., 10-107 STM unable to proceed., 10-38
Specimen Transport Module, 1-8 STM XY truck did not sense home on the X-
Input Buffer, 1-9 axis., 10-37
Mixer Wall and Aspiration Probe, 1-9 STM XY truck did not sense home on the Y-
Output Buffer, 1-10 axis., 10-38
Pending Buffer, 1-9 STM XY truck recovered from missed steps
SPM on the X-axis., 10-38
Dimensions, 1-29 STM XY truck recovered from missed steps
Icons, 1-24 on the Y-axis., 10-38
SPM alarm command failed., 10-88 Unexpected cassette at mix station moved to
SPM prime did not succeed., 10-88 output buffer., 10-39
SPM serial number undefined, 10-89 Unexpected cassette at pending buffer
SPM Specifications, 1-28 moved to the output buffer., 10-68
Status Bar, 1-22 STM MRC (Host ID: 50) not responding., 10-89
Status Mode Area, 1-21 STM unable to proceed., 10-38
STM, 1-8 STM XY truck did not sense home on the X-
STM module axis., 10-37
Cannot move the cassette into or out of the STM XY truck did not sense home on the Y-
mix station. OPERATOR MUST VERIFY axis., 10-38
TRANSPORT AREA IS CLEAR OF STM XY truck recovered from missed steps on
CASSETTES., 10-35 the X-axis., 10-38
Cassette did not engage the mixer wall. STM XY truck recovered from missed steps on
OPERATOR MUST VERIFY TRANSPORT the Y-axis., 10-38
AREA IS CLEAR OF CASSETTES., 10-35 Stripper vertical drive did not sense
Cassette mixer did not sense home., 10-35 home., 10-67
Cassette mixer missed steps while Stripper vertical drive sensed home after
mixing., 10-36 successful recovery., 10-67
Cassette not sensed on mixer wall during Studies, 5-19
mix routine., 10-36 Surface Plots, 6-29
Could not move cassette into or out of System backup not performed. SPM was
pending buffer. OPERATOR MUST busy., 10-98
VERIFY TRANSPORT AREA IS CLEAR OF System Manager
CASSETTES., 10-36 Logging On, 3-1
Could not move cassette out of the input System Setup, 9-6
buffer. OPERATOR MUST VERIFY Audible Alarms, 9-14
TRANSPORT AREA IS CLEAR OF Backup and Recovery, 9-7
CASSETTES., 10-36 Bar Code, 9-13
Could not move the cassette into or out of Database Cleanup, 9-8
the output buffer., 10-37 Date and Time, 9-11
Input buffer pushers did not sense Printer Setup, 9-10
home., 10-41 Studies, 9-16
Input buffer pushers missed steps during a System Configuration, 9-17
sweep., 10-55 System unexpectedly exited while backup was
Operating position of STM could not be in progress., 10-98
verified., 10-37
Output buffer is full., 10-42
Single tube station home position or tube T
cradle status could not be verified., 10-39 Temporarily Disable Analysis, 9-20

Index-13
Index

Termperature parsing., 10-90


Humidity, 1-28 Unexpected end tag during XML parsing., 10-90
Test panel definition contains an unrecognized Unexpected framework error. Call your Beckman
specimen type., 10-98 Coulter Representative., 10-90
Tests ordered could not be run., 10-89 Unexpected start tag during XML parsing., 10-90
The control lot you are running has Unlock DV Procedure, 10-25
expired., 10-98 Unprocessed specimen was not removed on
The database object was not found., 10-89 time., 10-98
The replacement of the consumable on SPM %1 was Unsupported result type received from System
interrupted., 10-89 Manager., 10-90
Throughput, 1-40 USM module
Timeout during processing of System Manager A matching patient specimen was found.
message., 10-89 Studies mode is enabled., 10-72
Timeout waiting for shift information A/D resource busy., 10-72
retrieval., 10-90 A/D resource insufficient pairs., 10-72
Timeout waiting for unit conversion., 10-90 A/D resource not monitoring., 10-73
Transmit Released Results, 6-13 A/D resource not ready., 10-73
Transport shield was opened., 10-39 A/D resource timeout., 10-73
Triple Transducer Module, 2-3 An invalid collation ID was received from the
Troubleshooting, 10-1 System Manager., 10-73
TTM, 2-3 An invalid primary ID was received., 10-73
Tube position ID no read, 10-90 An invalid secondary ID was received., 10-73
Tube was detected after a successful Attempt to acknowledge results receipt
recovery., 10-67 failed., 10-73
Tube was detected earlier than expected., 10-67 Attempt to perform auto stop failed., 10-74
Tube was not detected., 10-67 Attempt to retrieve audible alarm setting
Two or more CBC apertures had one or more failed., 10-74
parameters that exceeded the operating CAN bus impedance not terminated properly
limits., 10-68 for %1 MRC (Host ID: %2), 10-74
CAN bus impedance not terminated properly
for %1 MRC (Host ID: %2)., 10-74
U CBC calibrator lot has expired., 10-92
Unable to access PI CPU NVRAM, 10-98 CBC calibrator lot mismatch., 10-99
Unable to communicate with bar-code CBC MRC (Host ID: 10) not responding, 10-74
reader., 10-90 Communication timeout with SPM Module ID/
Unable to install SAX handler during XML Audio board., 10-75
parsing., 10-90 Could not read specimen bar code., 10-75
Unable to read waste status., 10-68 Could not read specimen ID or cassette bar
Unexpected cassette at mix station moved to codes., 10-75
output buffer., 10-39 Could not start maintenance procedure., 10-75
Unexpected cassette at pending buffer moved Daily Checks procedure incomplete., 10-75
to the output buffer., 10-68 Data stored on SPM Module ID/Audio board
Unexpected CDATA during XML parsing., 10-90 EEPROM is corrupt., 10-76
Unexpected CDATA received during XML Default order contained an invalid test., 10-76
parsing., 10-98 Diluent source switched., 10-93
Unexpected character data during XML Disconnected expansion board for %1 MRC
parsing., 10-90 (Host ID: %2)., 10-76
Unexpected characters during XML Duplicate specimen ID., 10-76
parsing., 10-98 Empty parameter definitions received., 10-76
Unexpected document end during XML

Index-14
Index

Empty test panel definitions received., 10-76 Invalid parameter group definitions., 10-82
Exception during results processing., 10-77 Invalid parameter received from System
Expansion ports communication error for %1 Manager., 10-82
MRC (Host ID: %2), 10-77 Invalid parameter result generated by the
Failed to complete result calculations., 10-78 System Manager algorithm., 10-82
Failed to connect to System Manager., 10-78, Invalid report request received from System
10-79 Manager., 10-106
Failed to process report., 10-99 Invalid reuse of specimen ID., 10-82
Failed to read IQAP definition file., 10-79 Invalid specimen type in default order., 10-82
Failed to restore configuration Invalid state reported for liquid detector
information., 10-79 sensor., 10-82
Failed to retrieve bar-code Invalid vector result sent for parameter., 10-83
configuration., 10-79 IQAP export cancelled: system restart., 10-93
Failed to retrieve batch mode., 10-79 IQAP export failed: duplicate
Failed to retrieve configuration transaction., 10-94
information., 10-79 IQAP export failed: not enrolled in
Failed to retrieve enabled parameters., 10-80 RMS., 10-94
Failed to retrieve parameter definitions., 10-80 IQAP export failed: RMS service not
Failed to retrieve report information., 10-80 available., 10-94
Failed to retrieve test panel definitions., 10-80 IQAP export failed: RMS transfer not
Failed to save database information., 10-80 completed., 10-94
Flow-cell clog., 10-93 IQAP export failed: system error., 10-94
Incompatible presentation mode for control Label order contained an invalid test., 10-83
specimen., 10-95 Maximum number of consecutive CBC module
Incompatible presentation mode for errors reached., 10-84
specimen., 10-95 Maximum number of consecutive CSM errors
Incompatible specimen type for label reached., 10-84
order., 10-80 Maximum number of consecutive Diff errors
Incompatible specimen type in default reached., 10-84
order., 10-81 Maximum number of consecutive duplicate
Incorrect number of specimens detected during specimen IDs reached., 10-85
Carryover procedure., 10-81 Maximum number of consecutive NRBC errors
Incorrect specimen type detected during reached., 10-84
Carryover procedure., 10-81 Maximum number of consecutive partial
Invalid bar-code format for specimen ID label voteouts reached., 10-96
[I2of5] digits., 10-81 Maximum number of consecutive Retic errors
Invalid CDATA element in report job result reached., 10-85
value., 10-105 Maximum number of consecutive SAM errors
Invalid CDATA elements were found in a reached., 10-85
report job., 10-105 Maximum number of No Match events
Invalid collation ID., 10-82 reached., 10-95
Invalid data for report job., 10-105 Maximum number of No Match events
Invalid data set used in report job., 10-106 reached., 10-83
Invalid event log message from System Maximum number of No Read events
Manager., 10-82 reached., 10-95
Invalid IQAP definitions read., 10-81 Maximum number of No Read events
Invalid label found on a control reached., 10-84
specimen., 10-82 Maximum number of Partial Aspiration
Invalid or missing report file for report events reached., 10-96
job., 10-106 Maximum number of Partial Aspiration events

Index-15
Index

reached., 10-84 Unprocessed specimen was not removed on


Maximum number of specimen mismatches time., 10-98
reached., 10-85 Unsupported result type received from System
Maximum number of Total Voteout events Manager., 10-90
reached., 10-96 VCSn MRC (Host ID: 20) not responding., 10-91
Maximum number of Total Voteout events Verification bar code read was not
reached., 10-84 successful., 10-91
Motor encoder reported missed steps., 10-85 VME POST failed for CBC SCA card., 10-91
Motor move to sensor timeout., 10-85 VME POST failed for Comm I/F card., 10-91
No pending tests found for specimen., 10-85 VME POST failed for VCSn SCA card., 10-91
No test order and no default order Waste container is full., 10-91
defined., 10-85 Utility Icons, 1-23
No test order could be generated., 10-85
No test order defined for batch
processing., 10-86 V
Prime procedure was not successful., 10-96 Vacuum chamber detected liquid., 10-71
Processed specimen was not removed on Vacuum chamber drain did not sense
time., 10-96 empty., 10-40
Reagent is depleted., 10-87 Vacuum chamber overflow detected., 10-40
Reagent is low., 10-97 VCS diluent pump delivery could not be
Reagent should be depleted., 10-87 verified., 10-68
Reagents not available., 10-87 VCS diluent pump did not sense home., 10-69
Rerun secondary ID did not match value in test VCS temperature exceeded the operating
order., 10-88 limits., 10-69
Resource concurrent use conflict., 10-88 VCS temperature is approaching the operating
Restart after unrecoverable exception., 10-88 limits., 10-70
RS MRC (Host ID: 30) not responding, 10-87 VCS waste chamber drain did not sense
SAM MRC (Host ID: 40) not responding., 10-88 empty., 10-70
Scheduled procedure skipped., 10-97, 10-98 VCSn Acquisition Time was longer than
Secondary ID did not match the value in test expected., 10-71
order., 10-89 VCSn Module, 1-11
Shutdown procedure incomplete., 10-98 VCSn module
Shutdown procedure incomplete., 10-89 A/D or MRC reference voltage exceeded the
Specimen ID verification failed., 10-89 operating limits., 10-43
Specimen ID verification failure for a A/D or MRC reference voltage is
specimen., 10-107 approaching the operating limits., 10-43
SPM alarm command failed., 10-88 DC or RF flow cell voltage exceeded the
SPM prime did not succeed., 10-88 operating limits., 10-47
SPM serial number undefined, 10-89 DC or RF flow cell voltage is approaching the
STM MRC (Host ID: 50) not responding., 10-89 operating limits., 10-47
Test panel definition contains an Diff lyse pump delivery could not be
unrecognized specimen type., 10-98 verified., 10-47
Tests ordered could not be run., 10-89 Diff lyse pump did not sense home., 10-48
The replacement of the consumable on SPM %1 Diff preservative pump delivery could not be
was interrupted., 10-89 verified., 10-48
Tube position ID no read, 10-90 Diff preservative pump did not sense
Unable to access PI CPU NVRAM, 10-98 home., 10-48
Unable to communicate with bar-code Distribution valve did not report expected
reader., 10-90 position., 10-48
Distribution valve did not sense

Index-16
Index

home., 10-48 VCSn MRC (Host ID: 20) not responding., 10-91
Distribution valve home recovered., 10-48 VCSn phase alignment did not complete
Distribution valve recovered expected successfully., 10-42
position., 10-49 VCSn temperature was not in operating range
Flow cell DC voltage exceeded the expected limits. Try again in 10 minutes., 10-42
range. Possible full clog., 10-52 Vent/overflow chamber detected
Light scatter offset exceeded the operating overflow., 10-40
limits., 10-55 Vent/overflow chamber drain did not sense
Light scatter offset is approaching the empty., 10-40
operating limits., 10-55 Verification bar code read was not
Mix pressure exceeded the operating successful., 10-91
limits., 10-55 Verify Blood Detectors Procedure, 10-25
Mix pressure is approaching the operating VME POST failed for CBC SCA card., 10-91
limits., 10-56 VME POST failed for Comm I/F card., 10-91
NRBC lyse pump delivery could not be VME POST failed for VCSn SCA card., 10-91
verified., 10-56
NRBC lyse pump did not sense home., 10-56
One or more Flow cell parameters exceeded W
operating limits., 10-56 Waste container is full., 10-91
Retic clear pump delivery could not be Waste Disposal Warning, 10-5
verified., 10-64 WBC pump delivery could not be verified., 10-71
Retic clear pump did not sense home., 10-65 WBC pump did not sense home., 10-71
Retic stain pump delivery could not be Worklist
verified., 10-65 Custom, 6-15
Retic stain pump did not sense home., 10-65 Advanced Search, 6-15
Sample or sheath pressure exceeded the Screen, 6-1
operating limits., 10-66 Tabs, 6-1
Sample or sheath pressure is approaching Not Processed, 6-7
the operating limits., 10-66 Pending, 6-3
Sheath or sample tank did not indicate full Released, 6-11
condition., 10-66 Review, 6-9
VCS diluent pump delivery could not be Workload, 7-1
verified., 10-68 Writing to barcode reader failed., 10-91
VCS diluent pump did not sense
home., 10-69 X
VCS temperature exceeded the operating
XB, 4-24
limits., 10-69
Setup, 9-93
VCS temperature is approaching the
XM, 4-32
operating limits., 10-70
Setup, 9-96
VCS waste chamber drain did not sense
XML is missing the format specification., 10-91
empty., 10-70
XML module
VCSn Acquisition Time was longer than
A NULL or empty XML string was received for
expected., 10-71
parsing., 10-72
VCSn Module unable to proceed., 10-39
An unknown attribute was encountered
VCSn phase alignment did not complete
while parsing object., 10-92
successfully., 10-42
An XML parser warning has occurred., 10-92
VCSn temperature was not in operating
An XML parsing error occurred., 10-73
range limits. Try again in 10
An XML parsing error occurred: empty
minutes., 10-42
attribute set for object., 10-73
VCSn Module unable to proceed., 10-39

Index-17
Index

An XML parsing error occurred: invalid


attribute value., 10-73
An XML parsing error: unknown start tag in
object., 10-92
An XML parsing warning: unknown end tag
in object., 10-92
Correct XML parser not installed., 10-75
Object meta type incorrect., 10-86
Persistent object not found., 10-87
SAX COM error., 10-88
The database object was not found., 10-89
Unable to install SAX handler during XML
parsing., 10-90
Unexpected CDATA during XML
parsing., 10-90
Unexpected CDATA received during XML
parsing., 10-98
Unexpected character data during XML
parsing., 10-90
Unexpected characters during XML
parsing., 10-98
Unexpected document end during XML
parsing., 10-90
Unexpected end tag during XML
parsing., 10-90
Unexpected start tag during XML
parsing., 10-90
XML is missing the format specification., 10-91
XML parsing error., 10-91
XML parsing error: duplicate start tag in
object., 10-91
XML parsing error: no attributes found., 10-91
XML parsing warning., 10-98
XML parsing error., 10-91
XML parsing error: duplicate start tag in
object., 10-91
XML parsing error: no attributes found., 10-91
XML parsing warning., 10-98

Z
ZAP Aperture Procedure, 10-14

Index-18
Beckman Coulter, Inc.
Customer End User License Agreement
This Product contains software that is owned by Beckman Coulter, Inc. or its suppliers and is
protected by United States and international copyright laws and international trade provisions.
You must treat the software contained in this Product like any other copyrighted material. This
license and your right to use the Product terminate automatically if you violate any part of this
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This is a license agreement and not an agreement for sale. Beckman Coulter hereby licenses this
Software to you under the following terms and conditions:

You May:

1. Use this software in the computer supplied to you by Beckman Coulter;

2. Maintain one copy of this software for backup purposes (the backup copy shall be supplied by
Beckman Coulter);

3. After written notification to Beckman Coulter, transfer the entire Product to another person or
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You May Not:

1. Use, copy or transfer copies of this Software except as provided in this license agreement;
2. Alter, merge, modify or adapt this Software in any way including disassembling or decompiling;

3. Loan, rent, lease, or sublicense this Software or any copy.

Limited Warranty

Beckman Coulter warrants that the software will substantially conform to the published
specifications for the Product in which it is contained, provided that it is used on the computer
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Except as specifically noted above, Beckman Coulter makes no warranty or representation, either
expressed or implied, with respect to this software or its documentation including quality,
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No Liability for Consequential Damages


In no event shall Beckman Coulter or its suppliers be liable for any damages whatsoever (including,
without limitation, damages for loss of profits, business interruption, loss of information, or other
pecuniary loss) arising out of the use of or inability to use the Beckman Coulter Product software.
Because some states do not allow the exclusion or limitation of liability for consequential damages,
the above limitation might not apply to you.

629743AE WARRANTY-1
Beckman Coulter, Inc. Customer End User License Agreement

General

This agreement constitutes the entire agreement between you and Beckman Coulter and
supersedes any prior agreement concerning this Product software. It shall not be modified except
by written agreement dated subsequent to the date of this agreement signed by an authorized
Beckman Coulter representative. Beckman Coulter is not bound by any provision of any purchase
order, receipt, acceptance, confirmation, correspondence, or otherwise, unless Beckman Coulter
specifically agrees to the provision in writing. This agreement is governed by the laws of the State
of Florida.

WARRANTY-2 629743AE
Trademarks

The BECKMAN COULTER logo , COULTER, UniCel, Erythrolyse, StabiLyse, LATRON, and S-CAL are trademarks of
Beckman Coulter, Inc.

All other trademarks, service marks, products, or services are trademarks or registered trademarks of their
respective holders.

629743AE TRADEMARKS-1
Related Documents
Your DxH 800 documentation can be found on
our website at www.beckmancoulter.com.

Instructions for Use


PN 629743
• System Overview
• Operation Principles
• Daily Checks
• Quality Control
• Sample Analysis
• Data Review
• Workload
• Shutdown
• Setup
• Troubleshooting
• Quality Assurance
• Cleaning Procedures
• Replacement Procedures
• Appendices
• Abbreviations
• Glossary
• References

Host Transmission Manual


PN 773765

www.beckmancoulter.com

© 2009 Beckman Coulter, Inc.


All Rights Reserved

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