RUO Addendum

UniCel DxH 900 Series with System Manager Software

Coulter Cellular Analysis System

Published Version:
DxH 900 and DxH 690T - v1

PN C11340AB
February 2019
Manufactured by
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.
UniCel DxH 900 Series with System Manager Software
Coulter Cellular Analysis System
RUO Addendum
PN C11340AB (February 2019)

UniCel DxH 900 Series with System Manager Software

includes the following instrument as an individual or
workcell (connected) system:

• UniCel DxH 900 Coulter Cellular Analysis System

and the following instrument as an individual system:
• UniCel DxH 690T Coulter Cellular Analysis System

Beckman Coulter, the stylized logo, and the Beckman

Coulter product and service marks mentioned herein are
trademarks or registered trademarks of Beckman Coulter,
Inc. in the United States and other countries.

All other trademarks, service marks, products, or services

are trademarks or registered trademarks of their
respective holders.

May be covered by one or more pat. - see

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

Symbols Glossary is available at:

www.beckmancoulter.com. See Related Documents for
the part number.

Rx Only in the U.S.A.

Original Instructions
 Revision History
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.

Initial Issue AA, 9/2017

Software version 1.0

Initial Issue AB, 2/2019

Software version 1.2.0
The following sections were modified:

• Added DxH 690T throughout the manual, as appropriate

• Changed VCSn to VCS 360 throughout this manual, as appropriate
• UniCel DxH 900 Series with System Manager Software Coulter Cellular Analysis System RUO
Addendum copyright page
• How to Use Your Manuals in the Introduction
• Conventions in the Introduction
• Related Documents

Note: Changes that are part of the most recent revision are indicated by a change bar in the left
margin of the page.

PN C11340AB iii
 Revision History

iv PN C11340AB
 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, Caution, Important, and Note

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.

PN C11340AB 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 PN C11340AB
 Contents

Revision History, iii

Safety Notice, v
Alerts for Warning, Caution, Important, and Note, v
Safety Precautions, vi

Introduction, ix
How to Use Your Manuals, ix
About This Manual, ix
Conventions, ix
System HELP, x
Graphics, x

CHAPTER 1: Research Use Only Parameters, 1-1

Research Use Only Parameters, 1-1
Cell Population Data, 1-3

CHAPTER 2: Enabling RUO Parameters, 2-1

Enabling RUO and CPD Parameters, 2-1
Activate RUO and CPD Parameters, 2-1
Using RUO and CPD in Decision Rules, 2-2

CHAPTER 3: Reporting, LIS Transmission, and Exporting, 3-1

Printed Reports, 3-1
Transmit, 3-5
RUO Parameters, 3-5
Transmit CPD, 3-5
Export, 3-5
RUO Parameters, 3-5
CPD, 3-5

Related Documents

vii
 Tables

Tables

1.1 Research Use Only Parameters, 1-1

1.2 Diff Cell Population Data, 1-4
1.3 NRBC Cell Population Data, 1-4
1.4 Retic Cell Population, 1-4

viii
 Introduction

How to Use Your Manuals

Use this Research Use Only (RUO) Addendum for a complete description of the Research Use Only
parameters included with your DxH 900/DxH 690T System.

Use the Instructions For Use (IFU) manual to assist you in the day-to-day running of your Specimen
Processing Module (SPM) and System Manager. Go through the detailed step-by-step procedures of
Daily Checks, Quality Control (QC), running samples, analyzing data, printing reports, and
Shutdown. The IFU contains performance, 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 Manual to find the information needed to program the transmission
interface between the DxH System and your laboratory’s host computer.

See Related Documents in this manual for the contents of each manual and to quickly determine
which manual contains the information you need.

About This Manual

The information in your Research Use Only Addendum is organized as follows:

• CHAPTER 1, Research Use Only Parameters

Contains a description of the DxH Research Use Only parameters.
• CHAPTER 2, Enabling RUO Parameters
Describes how to certify and enable Research Use Only parameters.
• CHAPTER 3, Reporting, LIS Transmission, and Exporting
Provides information on how to print, transmit, and export Research Use Only parameters.

Conventions
This manual uses the following conventions:

• Bold font indicates buttons on the System Manager screen.

• Italic 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

PN C11340AB ix
 Introduction
How to Use Your Manuals

• The instructions in this manual are presented at the Lab Administrator level. For detailed
instructions regarding other levels of operator access, see the Instructions for Use manual.

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 installation, use,
or servicing of this equipment.

VCS 360 in this manual is referred to as VCSn in the software.

System HELP
The DxH instruments have comprehensive System HELP, which includes reference information,
and all operating, maintenance and troubleshooting procedures. Select the HELP icon at the top
right of any screen to access System Help.

Graphics
All graphics, including screens and printouts, are for illustration purposes only. The appearance of
your screens may differ slightly from the graphics in this document.

x PN C11340AB
 CHAPTER 1
Research Use Only Parameters

Research Use Only Parameters

Research Use Only (RUO) parameters are identified with the @ symbol.

@ THESE PARAMETERS ARE FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES.

There are two categories of RUO parameters. Throughout this manual, parameters in
Table 1.1, Research Use Only Parameters are referred to as RUO. The remaining Research Use Only
parameters consist of a subcategory called Cell Population Data (CPD), which are grouped together
for reporting purposes. See Cell Population Data in this chapter.

Enabled RUO and CPD parameters can be displayed, printed on laboratory, chartable, and
cumulative reports, transmitted to a host, and exported to a .csv file. RUO and CPD parameters can
also be used to write Decision Rules to enhance laboratory workflow.

Table 1.1 Research Use Only Parameters

Parameter Method Description (US1 Reporting Format)

@BFM Coulter Principle Body Fluid Mononuclear Cell Percent
• Mononuclear cell population (lymph and mononuclear) derived
from the TNC histogram
• Expressed as a percentage
@BFM# Calculated Body Fluid Mononuclear Cell Absolute Count
• @BFM# = [@BFM * corrected TNC]/100
• Expressed as N X 103 cells/mL
@BFP Coulter Principle Body Fluid Polymorphonuclear Cell Percent
• Polymorphonuclear cell population derived from the TNC
histogram
• Expressed as a percentage
@BFP# Calculated Body Fluid Polymorphonuclear Cell Absolute Count
• @BFP# = [@BFP * corrected TNC]/100
• Expressed as N X 103 cells/mL
@EGC Derived from DIFF Early Granulated Cell Percent
measurement in • Early granulocytes enumerated from the DIFF VCS 360
VCS 360 technology technology
• Expressed as a percentage of total WBC events
@EGC# Calculated Early Granulated Cell Absolute Count
• @EGC# = (@EGC * WBC)/100
• Expressed as N X 103 cells/µL

PN C11340AB 1-1
 Research Use Only Parameters
Research Use Only Parameters

Table 1.1 Research Use Only Parameters (Continued)

Parameter Method Description (US1 Reporting Format)

@HLR Derived from RET High Light Scatter Reticulocytes Percent
measurements in • Percentage of High Light Scatter Retics in Regions 3 -10 of the
VCS 360 technology total RBC events
• Expressed as a percentage
@HLR# Calculated High Light Scatter Reticulocytes Absolute Count
• @HLR# = (@HLR * RBC)/100
• Expressed as N X 106 cells/µL
@LHD Calculated Low Hemoglobin Density

•
• Where d and Q are constants
• Uses the corrected MCHC, when appropriate
• Expressed as a percentage
@MAF Calculated Microcytic Anemia Factor
• @MAF = (HGB * MCV)/100
• Uses the corrected HGB and/or MCV, when appropriate
• Expressed without a unit label
@MSCV Derived from RET Mean Sphered Cell Volume
measurements in • Sphered red cells that are cleared of hemoglobin in
VCS 360 technology preparation for Retic measurements
• Expressed in fL
@PCT Calculated Plateletcrit
• The relative volume of platelets to whole blood
• Expressed as a percentage
@PDW Derived from PLT Platelet Distribution Width
histogram • The size distribution of the platelet population derived from the
PLT histogram
• Geometric standard deviation multiplied by a scaling factor
• No reporting unit
@RDWR Derived from RET Reticulocyte Distribution Width CV
measurements in • The size distribution spread of the reticulocyte population
VCS 360 technology
• Expressed as a coefficient of variation
@RDWR-SD Derived from RET Reticulocyte Distribution Width - SD
measurements in • The size distribution spread of the reticulocyte population
VCS 360 technology
• Expressed as a standard deviation in fL
@RSF Calculated Red Blood Cell Size Factor
• Characterizes the red cell size

1-2 PN C11340AB
 Research Use Only Parameters
Research Use Only Parameters 1

Table 1.1 Research Use Only Parameters (Continued)

Parameter Method Description (US1 Reporting Format)

@UGC Derived from RET Unghosted Red Cell Percent
measurements in • Red cells that are incompletely cleared of hemoglobin
VCS 360 technology enumerated from the RET in VCS 360 technology
• Expressed as a percentage of total RBC events
@UGC# Derived from RET Unghosted Red Cell Absolute Number
measurements in • @UGC# = (@UGC * RBC)/100
VCS 360 technology
• Expressed as N X 106 cells/µL
@UWROP Derived from RET Leukocyte Estimate (Uncorrected) from the RET Optical
measurements in Channel
VCS 360 technology
• Expressed as N X 103 cells/µL
@WDOP Derived from DIFF Leukocyte Estimate (Corrected) from the DIFF Optical Channel
measurements in
• Expressed as N X 103 cells/µL
VCS 360 technology
@WNOP Derived from NRBC Leukocyte Estimate (Corrected) from the NRBC Optical
measurements in Channel
VCS 360 technology
• Expressed as N X 103 cells/µL
@WROP Derived from RET Leukocyte Estimate (Corrected) from the RET Optical Channel
measurements in
• Expressed as N X 103 cells/µL
VCS 360 technology

Cell Population Data

Cell Population Data (CPD) is based on 256 channels of histogram data for each VCS 360
measurement (V, C, MALS, UMALS, LMALS, LALS, AL2) and the standard deviation of each
population. CPD are often referred to as positional parameters and are provided as additional tools
for investigation.

PN C11340AB 1-3
 Research Use Only Parameters
Research Use Only Parameters

Number Description
1 Volume SD (19.09)
2 Volume Mean Channel (168)

When enabled, CPD is displayed on Additional Data screens and can be printed on laboratory
reports, exported to .csv, or transmitted to the LIS.

Table 1.2 Diff Cell Population Data

Mean Ne SD Ne Mean Ly SD Ly Mean Mo SD Mo Mean Eo SD Eo Mean EGC SD EGC

V @MN-V-NE @SD-V-NE @MN-V-LY @SD-V-LY @MN-V-MO @SD-V-MO @MN-V-EO @SD-V-EO @MN-V- @SD-V-
EGC EGC
C @MN-C-NE @SD-C-NE @MN-C-LY @SD-C-LY @MN-C-MO @SD-C-MO @MN-C-EO @SD-C-EO @MN-C- @SD-C-
EGC EGC
MALS @MN- @SD- @MN- @SD- @MN- @SD-MALS- @MN- @SD- @MN- @SD-
MALS-NE MALS-NE MALS-LY MALS-LY MALS-MO MO MALS-EO MALS-EO MALS-EGC MALS-EGC
UMALS @MN- @SD- @MN- @SD- @MN- @SD- @MN- @SD- @MN- @SD-
UMALS-NE UMALS-NE UMALS-LY UMALS-LY UMALS-MO UMALS-MO UMALS-EO UMALS-EO UMALS- UMALS-
EGC EGC
LMALS @MN- @SD- @MN- @SD- @MN- @SD- @MN- @SD- @MN- @SD-
LMALS-NE LMALS-NE LMALS-LY LMALS-LY LMALS-MO LMALS-MO LMALS-EO LMALS-EO LMALS-EGC LMALS-EGC
LALS @MN- @SD-LALS- @MN-LALS- @SD- @MN-LALS- @SD-LALS- @MN- @SD-LALS- @MN-LALS- @SD-LALS-
LALS-NE NE LY LALS-LY MO MO LALS-EO EO EGC EGC
AL2 @MN-AL2- @SD-AL2- @MN-AL2- @SD-AL2- @MN-AL2- @SD-AL2- @MN-AL2- @SD-AL2- @MN-AL2- @SD-AL2-
NE NE LY LY MO MO EO EO EGC EGC

Table 1.3 NRBC Cell Population Data

Mean NRBC SD NRBC Mean Non-NRBC SD Non-NRBC

V @MN-V-NRBC @SD-V-NRBC @MN-V-NNRBC @SD-V-NNRBC
C @MN-C-NRBC @SD-C-NRBC @MN-C-NNRBC @SD-C-NNRBC
MALS @MN-MALS-NRBC @SD-MALS-NRBC @MN-MALS-NNRBC @SD-MALS-NNRBC
UMALS @MN-UMALS-NRBC @SD-UMALS-NRBC @MN-UMALS-NNRBC @SD-UMALS-NNRBC
LMALS @MN-LMALS-NRBC @SD-LMALS-NRBC @MN-LMALS-NNRBC @SD-LMALS-NNRBC
LALS @MN-LALS-NRBC @SD-LALS-NRBC @MN-LALS-NNRBC @SD-LALS-NNRBC
AL2 @MN-AL2-NRBC @SD-AL2-NRBC @MN-AL2-NNRBC @SD-AL2-NNRBC

Table 1.4 Retic Cell Population

Mean Retic SD Retic Mean Non-Retic SD Non-Retic Mean UGC SD UGC

V @MN-V-RET @SD-V-RET @MN-V-NRET @SD-V-NRET @MN-V-UGC @SD-V-UGC
C @MN-C-RET @SD-C-RET @MN-C-NRET @SD-C-NRETC @MN-C-UGC @SD-C-UGC
MALS @MN-MALS-RET @SD-MALS-RET @MN-MALS- @SD-MALS- @MN-MALS-UGC @SD-MALS-UGC
NRET NRET
UMALS @MN-UMALS- @SD-UMALS- @MN-UMALS- @SD-UMALS- @MN-UMALS- @SD-UMALS-
RET RET NRET NRET UGC UGC

1-4 PN C11340AB
 Research Use Only Parameters
Research Use Only Parameters 1

Table 1.4 Retic Cell Population (Continued)

Mean Retic SD Retic Mean Non-Retic SD Non-Retic Mean UGC SD UGC

LMALS @MN-LMALS- @SD-LMALS-RET @MN-LMALS- @SD-LMALS- @MN-LMALS- @SD-LMALS-
RET NRET NRET UGC UGC
LALS @MN-LALS-RET @SD-LALS-RET @MN-LALS- @SD-LALS-NRET @MN-LALS-UGC @SD-LALS-UGC
NRET
AL2 @MN-AL2-RET @SD-AL2-RET @MN-AL2-NRET @SD-AL2-NRET @MN-AL2-UGC @SD-AL2-UGC

PN C11340AB 1-5
 Research Use Only Parameters
Research Use Only Parameters

1-6 PN C11340AB
 CHAPTER 2
Enabling RUO Parameters

Enabling RUO and CPD Parameters

You must log on with an Operator ID with Lab Administrator privileges (Level III) to enable RUO and
CPD parameter features.

NOTE Once the RUO and CPD parameters are activated (certified), they cannot be deactivated.

• CPD parameters will be displayed on all applicable screens.

• CPD parameters will be printed on the lab report when the Cell Population Data check box is
selected using Menu > Setup > Reporting > Patient Report.
• CPD will transmit to your LIS when the Cell Population Data check box is selected using Menu >
Setup > Communications > LIS.
• RUO parameters will be displayed, printed, and transmitted identically to IVD parameters after
being enabled.

Activate RUO and CPD Parameters

1 Select Menu > Setup > Reporting to display the Reporting screen.

2 Select Tests from the local navigation bar to display the Enable/Disable Tests dialog box.

3 Select Additional Tests.

4 On the Research Use Only Parameters - User Agreement Notice, select OK to display the
Validate Current User dialog box.

5 On the Validate Current User dialog box, enter your Operator ID and Password, and select OK.

NOTE RUO and CPD parameters are now activated. The CPD parameters will be automatically displayed
on the applicable screens including the Additional Data displays from the Patient Results screen.
The Enable/Disable Test screen is displayed. To enable RUO parameters, go to the next step.

PN C11340AB 2-1
 Enabling RUO Parameters
Using RUO and CPD in Decision Rules

6 Select the RUO parameters from the Enable/Disable Tests screen that you want to enable
(displayed, printed, and transmitted) and select OK.

NOTE Once RUO and CPD certification is enabled, it cannot be disabled. Parameter results can be
excluded from the screens (except CPD), printouts, and transmissions.

Select RUO Agreement to reprint the RUO User Agreement Notice, as needed.

Using RUO and CPD in Decision Rules

RUO and CPD parameters can be used in Decision Rules.

See the Instructions for Use manual for more information.

2-2 PN C11340AB
 CHAPTER 3
Reporting, LIS Transmission, and Exporting

Printed Reports

Enabled RUO parameters will be displayed on chartable, laboratory, and cumulative reports. An
example of a laboratory report with all parameters enabled for reporting is shown on the following
pages.

Enabled CPD parameters will be displayed on their own page of laboratory reports after the print
capability is turned on as follows:

1 Select Setup > Reporting > Patient Report. The Patient Report dialog box will be displayed.

2 Select the Cell Population Data check box in the Lab Report section of the dialog box.

PN C11340AB 3-1
 Reporting, LIS Transmission, and Exporting
Printed Reports

3 Select OK to display the Patient Lab Report. The report spans three pages when all parameters
are enabled (RUO and CPD). Page 1 displays IVD information. Page 2 displays RUO information.
Page 3 displays CPD information.

3-2 PN C11340AB
 Reporting, LIS Transmission, and Exporting
Printed Reports 3

PN C11340AB 3-3
 Reporting, LIS Transmission, and Exporting
Printed Reports

3-4 PN C11340AB
 Reporting, LIS Transmission, and Exporting
Transmit 3

Transmit

RUO Parameters
Enabled RUO parameters are automatically transmitted to the LIS.

Transmit CPD

1 Select Menu > Setup > Communications > LIS. The LIS window is displayed.

2 Select LIS Interface > Off.

3 Select the Cell Population Data check box.

4 Select LIS Interface > ON to transmit CPD to the LIS.

Export

NOTE You must have Level II access or higher to export patient data.

RUO Parameters
Enabled RUO parameters are included in a separate export file with the extension _RUO.csv
(filename_RUO.csv).

CPD
Enabled CPD are included in a separate export file with the extension _CPD.csv (filename_CPD.csv).

PN C11340AB 3-5
 Reporting, LIS Transmission, and Exporting
Export

3-6 PN C11340AB
 Index

Symbols E
@BFM, 1-1 export CPD, 3-5
@BFM#, 1-1
@BFP, 1-1
@BFP#, 1-1 G
@EGC, 1-1 graphics, -x
@EGC#, 1-1
@HLR, 1-2 M
@HLR#, 1-2
manuals
@LHD, 1-2
updates, iii
@MAF, 1-2
updating, iii
@MSCV, 1-2
@PCT, 1-2
@PDW, 1-2 R
@RDWR, 1-2 reports, 3-1
@RDWR-SD, 1-2 Research Use Only Parameters, 1-1
@RSF, 1-2 RUO and CPD in decision rules, 2-2
@UGC, 1-3 RUO and CPD parameters, activate, 2-1
@UGC#, 1-3 RUO parameters, set up, 2-1
@UWROP, 1-3
@WDOP, 1-3
@WNOP, 1-3 T
@WROP, 1-3 transmit CPD, 3-5

A U
About this Manual, ix Using your UniCel DxH Manuals, ix
alerts for warning and caution, -v
W
C warning, alert for caution and, -v
caution, alert for warning and, -v
Cell Population Data, 1-3
Cell Population Data (CPD), 1-3
conventions, -ix
CPD and RUO in decision rules, 2-2
CPD and RUO parameters, activate, 2-1
CPD, export, 3-5
CPD, transmit, 3-5

D
decision rules, RUO and CPD, 2-2

Index-1
 Index

Index-2
 Related Documents
Your DxH documentation can be found on our
website at www.beckmancoulter.com.

Instructions for Use

PN C06947
• System Overview
• Operation Principles
• Daily Checks
• Quality Control
• Sample Analysis
• Data Review
• Workload
• Shutdown
• Setup
• Troubleshooting
• Quality Assurance
• Cleaning Procedures
• Replacement/Adjustment Procedures
• Appendices
• Abbreviations and Acronyms
• Glossary
• References
• Index
• Warranty

Host Transmission

PN B26711

Symbols Glossary

PN C29230

www.beckmancoulter.com

© 2017-2019 Beckman Coulter, Inc.

All Rights Reserved