Information-Update Addendum
DxH 500 Series Hematology Analyzers
Published Version: v2
PN C80670AA
June 2022
Manufactured by
Beckman Coulter Ireland Inc.
Lismeehan
O’Callaghan’s Mills
Co. Clare, Ireland 353-65-683-1100
DxH 500 Series Hematology Analyzers
Information-Update Addendum
PN C80670AA (June 2022)
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/techdocs. 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/techdocs and download the latest version of the
manual or system help for your instrument.
Initial Issue AA, June 2022
Software version 2.7
PN C80670AA
iii
Revision History
iv
PN C80670AA
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.
Notice to User
For a patient/user/third party in the European Union and in countries with identical regulatory
regime (Regulation 2017/746/EU on In Vitro Diagnostic Medical Devices); if, during the use of this
device or as a result of its use, a serious incident has occurred, please report it to the manufacturer
and/or its authorized representative and to your national authority.
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.
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.
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v
Safety Notice
Safety Precautions
Safety Precautions
WARNING
Risk of operator injury and/or biohazardous contamination 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.
• You do not scan removable media (USB flash drive) before connecting it to a
computer. Always scan removable media.
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
vi
PN C80670AA
Safety Notice
Safety Symbols
product. If you purchased this product from a third party and would like further
information concerning this topic, call your Beckman Coulter Representative.
Safety Symbols
Symbol
PN C80670AA
Warning Condition
Action
Biohazard
Use universal precautions when working with
pathogenic materials. Means must be available to
decontaminate the instrument and to dispose of
biohazardous waste.
Caution/Warning
See Alerts for Warning, Caution, Important, and Note
for more information.
Hot Surface
Hot surfaces in this area. Avoid contact with any
surface in this area until you are sure that it has
cooled down first.
Pinch Point
Potential pinch or pierce point in this area. Be aware
of the moving probe and carefully present the test
sample to avoid injury.
vii
Safety Notice
Safety Symbols
viii
PN C80670AA
Contents
Revision History, iii
Safety Notice, v
Notice to User, v
Alerts for Warning, Caution, Important, and Note, v
Safety Precautions, vi
Safety Symbols, vii
Introduction, xix
What Documents Are Affected, xix
About This Addendum, xix
Conventions, xix
Graphics, xx
CHAPTER 1:
Updates to the DxH 500 Instructions for Use, 1-1
Overview, 1-1
Safety Notice, 1-1
Description of Change, 1-1
Location of Change, 1-1
New/Updated Information, 1-1
Electromagnetic Compatibility (EMC), 1-1
Keyboard, 1-2
Description of Change, 1-2
Location of Change, 1-2
New/Updated Information, 1-3
Aspiration, 1-3
Description of Change, 1-3
Location of Change, 1-3
New/Updated Information, 1-3
Startup, 1-4
Description of Change, 1-4
Location of Change, 1-4
New/Updated Information, 1-4
Logging On/Logging Off, 1-4
Description of Change, 1-4
Location of Change, 1-4
New/Updated Information, 1-4
ix
Contents
Logging On/Logging Off, 1-4
Identifying Patient Samples, 1-7
Description of Change, 1-7
Location of Change, 1-7
New/Updated Information, 1-7
Running Whole-Blood Samples, 1-10
Description of Change, 1-10
Location of Change, 1-10
New/Updated Information, 1-10
Running Whole-Blood Samples, 1-10
Running Prediluted-Blood Samples, 1-13
Description of Change, 1-13
Location of Change, 1-13
New/Updated Information, 1-13
Running Prediluted-Blood Samples, 1-13
Messages Displayed, 1-17
Description of Change, 1-17
Location of Change, 1-17
New/Updated Information, 1-17
Messages, 1-17
Description of Change, 1-17
Location of Change, 1-17
New/Updated Information, 1-18
Definitive Messages, 1-18
Description of Change, 1-18
Location of Change, 1-18
New/Updated Information, 1-18
Performing a Shutdown, 1-18
Description of Change, 1-18
Location of Change, 1-18
New/Updated Information, 1-18
Performing a Shutdown, 1-18
Powering Down, 1-20
Description of Change, 1-20
Location of Change, 1-20
New/Updated Information, 1-20
Setting Up Security Access, 1-20
Description of Change, 1-20
Location of Change, 1-21
New/Updated Information, 1-21
Setting Up Security Access, 1-21
Setting Up Auto Logout, 1-22
Description of Change, 1-22
Location of Change, 1-22
New/Updated Information, 1-22
x
Contents
Setting Up Auto Logout, 1-22
Setting Up Next Specimen, 1-23
Description of Change, 1-23
Location of Change, 1-23
New/Updated Information, 1-24
Setting Up Next Specimen, 1-24
Setting Up LIS, 1-24
Description of Change, 1-24
Location of Change, 1-24
New/Updated Information, 1-24
Setting Up LIS, 1-24
Updating the Printer Driver, 1-25
Description of Change, 1-25
Location of Change, 1-26
New/Updated Information, 1-26
Updating the Printer Driver, 1-26
Setting Up and Editing Controls, 1-26
Description of Change, 1-26
Location of Change, 1-26
New/Updated Information, 1-26
Setting Up and Editing Controls, 1-26
Removing All Patient Health Information, 1-27
Event Messages, 1-28
Description of Change, 1-28
Location of Change, 1-28
New/Updated Information, 1-28
Valve Checks (Now Check Valves), 1-29
Description of Change, 1-29
Location of Change, 1-29
New/Updated Information, 1-29
Check Valves, 1-29
Running Repeatability, 1-30
Description of Change, 1-30
Location of Change, 1-30
New/Updated Information, 1-30
Running Repeatability, 1-30
When, Why, and How to Perform Each Cleaning Procedure, 1-31
Description of Change, 1-31
Location of Change, 1-31
New/Updated Information, 1-32
Access Levels, 1-32
Description of Change, 1-32
Location of Change, 1-32
New/Updated Information, 1-32
xi
Contents
Reports, 1-33
Description of Change, 1-33
Location of Change, 1-33
New/Updated Information, 1-33
Bar-Code Label Specifications, 1-35
Description of Change, 1-35
Location of Change, 1-35
New/Updated Information, 1-36
CHAPTER 2:
Updates to the DxH 520 Instructions for Use, 2-1
Overview, 2-1
Safety Notice, 2-1
Description of Change, 2-1
Location of Change, 2-1
New/Updated Information, 2-1
Electromagnetic Compatibility (EMC), 2-1
Keyboard, 2-2
Description of Change, 2-2
Location of Change, 2-2
New/Updated Information, 2-3
Aspiration, 2-3
Description of Change, 2-3
Location of Change, 2-3
New/Updated Information, 2-3
Startup, 2-4
Description of Change, 2-4
Location of Change, 2-4
New/Updated Information, 2-4
Logging On/Logging Off, 2-4
Description of Change, 2-4
Location of Change, 2-4
New/Updated Information, 2-4
Logging On/Logging Off, 2-4
Identifying Patient Samples, 2-7
Description of Change, 2-7
Location of Change, 2-7
New/Updated Information, 2-7
Running Whole-Blood Samples in Closed-Vial Mode, 2-10
Description of Change, 2-10
Location of Change, 2-10
New/Updated Information, 2-11
Running Whole-Blood Samples in Closed-Vial Mode, 2-11
Running Whole-Blood Samples in Open-Vial Mode, 2-14
Description of Change, 2-14
Location of Change, 2-14
xii
Contents
New/Updated Information, 2-14
Running Whole-Blood Samples in Open-Vial Mode, 2-14
Running Prediluted-Blood Samples, 2-17
Description of Change, 2-17
Location of Change, 2-17
New/Updated Information, 2-17
Running Prediluted-Blood Samples, 2-17
Messages Displayed, 2-21
Description of Change, 2-21
Location of Change, 2-21
New/Updated Information, 2-21
Messages, 2-21
Description of Change, 2-21
Location of Change, 2-21
New/Updated Information, 2-22
Definitive Messages, 2-22
Description of Change, 2-22
Location of Change, 2-22
New/Updated Information, 2-22
Performing a Shutdown, 2-22
Description of Change, 2-22
Location of Change, 2-22
New/Updated Information, 2-22
Performing a Shutdown, 2-22
Powering Down, 2-24
Description of Change, 2-24
Location of Change, 2-24
New/Updated Information, 2-24
Setting Up Security Access, 2-24
Description of Change, 2-24
Location of Change, 2-25
New/Updated Information, 2-25
Setting Up Security Access, 2-25
Setting Up Auto Logout, 2-26
Description of Change, 2-26
Location of Change, 2-26
New/Updated Information, 2-26
Setting Up Auto Logout, 2-26
Setting Up Next Specimen, 2-27
Description of Change, 2-27
Location of Change, 2-27
New/Updated Information, 2-28
Setting Up Next Specimen, 2-28
Setting Up LIS, 2-28
Description of Change, 2-28
xiii
Contents
Location of Change, 2-28
New/Updated Information, 2-28
Setting Up LIS, 2-28
Updating the Printer Driver, 2-29
Description of Change, 2-29
Location of Change, 2-30
New/Updated Information, 2-30
Updating the Printer Driver, 2-30
Setting Up and Editing Controls, 2-30
Description of Change, 2-30
Location of Change, 2-30
New/Updated Information, 2-30
Setting Up and Editing Controls, 2-30
Removing All Patient Health Information, 2-31
Event Messages, 2-32
Description of Change, 2-32
Location of Change, 2-32
New/Updated Information, 2-32
Valve Checks (Now Check Valves), 2-33
Description of Change, 2-33
Location of Change, 2-33
New/Updated Information, 2-33
Check Valves, 2-33
Running Repeatability, 2-33
Description of Change, 2-33
Location of Change, 2-33
New/Updated Information, 2-34
Running Repeatability, 2-34
When, Why, and How to Perform Each Cleaning Procedure, 2-36
Description of Change, 2-36
Location of Change, 2-36
New/Updated Information, 2-37
Cleaning the WBC Bath Filter, 2-37
Description of Change, 2-37
Location of Change, 2-37
New/Updated Information, 2-37
Access Levels, 2-38
Description of Change, 2-38
Location of Change, 2-38
New/Updated Information, 2-38
Reports, 2-38
Description of Change, 2-38
Location of Change, 2-38
New/Updated Information, 2-39
xiv
Contents
Bar-Code Label Specifications, 2-41
Description of Change, 2-41
Location of Change, 2-41
New/Updated Information, 2-42
CHAPTER 3:
Updates to the DxH 560 Instructions for Use, 3-1
Overview, 3-1
Safety Notice, 3-1
Description of Change, 3-1
Location of Change, 3-1
New/Updated Information, 3-1
Electromagnetic Compatibility (EMC), 3-1
Intended Use, 3-2
Description of Change, 3-2
Location of Change, 3-2
New/Updated Information, 3-2
Cassettes, 3-3
Description of Change, 3-3
Location of Change, 3-3
New/Updated Information, 3-3
Cassettes, 3-3
Cassette Labels, 3-4
Description of Change, 3-4
Location of Change, 3-5
New/Updated Information, 3-5
Cassette Labels, 3-5
Aspiration, 3-6
Description of Change, 3-6
Location of Change, 3-6
New/Updated Information, 3-6
Method Comparison Specifications - Prediluted versus Whole Blood, 3-6
Description of Change, 3-6
Location of Change, 3-6
New/Updated Information, 3-7
Method Comparison Specifications - Prediluted Versus Whole
Blood, 3-7
Repeatability, 3-8
Description of Change, 3-8
Location of Change, 3-8
New/Updated Information, 3-8
Measuring and Operating Ranges, and Linearity, 3-10
Description of Change, 3-10
Location of Change, 3-10
New/Updated Information, 3-10
Sample Stability and Storage - Prediluted Whole Blood, 3-11
xv
Contents
Description of Change, 3-11
Location of Change, 3-11
New/Updated Information, 3-11
Sample Stability and Storage - Prediluted Whole Blood, 3-11
Startup, 3-11
Description of Change, 3-11
Location of Change, 3-11
New/Updated Information, 3-11
Logging On/Logging Off, 3-12
Description of Change, 3-12
Location of Change, 3-12
New/Updated Information, 3-12
Logging On/Logging Off, 3-12
Specimen Collection, 3-14
Description of Change, 3-14
Location of Change, 3-14
New/Updated Information, 3-15
Loading Cassettes, 3-15
Description of Change, 3-15
Location of Change, 3-15
New/Updated Information, 3-15
Loading Cassettes, 3-15
Running Sample Analysis, 3-19
Description of Change, 3-19
Location of Change, 3-19
New/Updated Information, 3-19
Running Whole-Blood Samples in Cassette Presentation, 3-20
Description of Change, 3-20
Location of Change, 3-20
New/Updated Information, 3-21
Running Whole-Blood Samples in Cassette Presentation, 3-21
Running Whole-Blood Samples in Open-Vial Mode, 3-25
Description of Change, 3-25
Location of Change, 3-25
New/Updated Information, 3-25
Running Prediluted-Blood Samples, 3-25
Description of Change, 3-25
Location of Change, 3-25
New/Updated Information, 3-26
Running Prediluted-Blood Samples, 3-26
Performing a Shutdown, 3-29
Description of Change, 3-29
Location of Change, 3-30
New/Updated Information, 3-30
Performing a Shutdown, 3-30
xvi
Contents
Powering Down, 3-31
Description of Change, 3-31
Location of Change, 3-31
New/Updated Information, 3-31
Setting Up Auto Logout, 3-32
Description of Change, 3-32
Location of Change, 3-32
New/Updated Information, 3-32
Setting Up Auto Logout, 3-32
Setting Up LIS, 3-33
Description of Change, 3-33
Location of Change, 3-33
New/Updated Information, 3-34
Setting Up LIS, 3-34
Updating the Printer Driver, 3-35
Description of Change, 3-35
Location of Change, 3-35
New/Updated Information, 3-35
Updating the Printer Driver, 3-35
Diluent Dispense, 3-35
Description of Change, 3-35
Location of Change, 3-35
New/Updated Information, 3-35
Diluent Dispense, 3-35
Valve Checks (Now Check Valves), 3-37
Description of Change, 3-37
Location of Change, 3-37
New/Updated Information, 3-37
Check Valves, 3-37
When, Why, and How to Perform Each Cleaning Procedure, 3-37
Description of Change, 3-37
Location of Change, 3-37
New/Updated Information, 3-37
Cleaning the WBC Bath Filter, 3-38
Description of Change, 3-38
Location of Change, 3-38
New/Updated Information, 3-38
Access Levels, 3-39
Description of Change, 3-39
Location of Change, 3-39
New/Updated Information, 3-39
Reports, 3-39
Description of Change, 3-39
Location of Change, 3-39
New/Updated Information, 3-40
xvii
Contents
Training Checklist, 3-41
Description of Change, 3-41
Location of Change, 3-41
New/Updated Information, 3-41
Abbreviations and Acronyms, 3-42
Description of Change, 3-42
Location of Change, 3-42
New/Updated Information, 3-42
Glossary, 3-42
Description of Change, 3-42
Location of Change, 3-42
New/Updated Information, 3-42
Related Documents
xviii
Introduction
What Documents Are Affected
This information-update addendum describes the updates to your Instructions for Use (IFU) for the
DxH 500, DxH 520, and DxH 560 (see Related Documents for the IFU part numbers).
The location of the new or updated information is identified by chapter name, heading name,
and/or procedure name and step number, as appropriate.
Keep this addendum with your current documentation.
About This Addendum
NOTE Screens and hardware depicted in this addendum may differ slightly from the screens and hardware
in your system configuration.
The information in this DxH 500 Series Hematology Analyzers Information-Update Addendum is
organized as follows:
CHAPTER 1, Updates to the DxH 500 Instructions for Use
Provides information on updates for the DxH 500 IFU. See Related Documents for the IFU part
number.
CHAPTER 2, Updates to the DxH 520 Instructions for Use
Provides information on updates for the DxH 520 IFU. See Related Documents for the IFU part
number.
CHAPTER 3, Updates to the DxH 560 Instructions for Use
Provides information on updates for the DxH 560 IFU. See Related Documents for the IFU part
number.
Conventions
This manual uses the following conventions:
• Bold font indicates selections on the screens.
• Italics font indicates new or updated text.
• The term Select is used to indicate tapping or touching the screen with your finger.
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xix
Introduction
About This Addendum
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.
Graphics
All graphics, including screens and printouts, are for illustration purposes only and must not be
used for any other purpose.
xx
PN C80670AA
CHAPTER 1
Updates to the DxH 500 Instructions for Use
Overview
This chapter describes the updates to your Instructions for Use (IFU) for the DxH 500 (see Related
Documents for the IFU part number).
Keep this addendum with your current documentation.
Safety Notice
Description of Change
The Electromagnetic Compatibility (EMC) Information section has been updated.
Location of Change
Electromagnetic Compatibility (EMC) Information section in the Safety Notice
New/Updated Information
Electromagnetic Compatibility (EMC)
This device complies with the emissions and immunity requirements as specified in the EN/IEC
61326 series of Product Family Standards for a “basic electromagnetic environment.” Such
equipment is supplied directly at low voltage from public mains network. This equipment is not
intended for residential use.
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1-1
Updates to the DxH 500 Instructions for Use
Keyboard
IMPORTANT This device generates, uses, and can radiate unintentional radio-frequency (RF) energy. If this
device is not installed and operated correctly, this RF energy can cause interference with other
equipment. It is the responsibility of the end user to be sure that a compatible electromagnetic
environment for the device can be maintained so that the device operates as intended. This equipment
is designed for use in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT. It is likely to perform
incorrectly if used in a HOME HEALTHCARE ENVIRONMENT. If it is suspected that performace is affected
by electromagnetic interference, correct operation may be restored by increasing the distance between
the equipment and the source of the interference.
In addition, other equipment can radiate RF energy to which this device is sensitive. If one suspects
interference between this device and other equipment, Beckman Coulter recommends the
following actions to correct the interference:
• Evaluate the electromagnetic environment before installation and operation of this device.
• Do not operate this device close to sources of strong electromagnetic radiation (for example:
unshielded intentional RF sources), as these can interfere with proper operation. Examples of
unshielded intentional radiators are handheld radio transmitters, cordless phones, and cellular
phones.
• Do not place this device near medical electrical equipment that can be susceptible to
malfunctions caused by close-proximity to electromagnetic fields.
• This device has been designed and tested to CISPR 11, Class A emission limits. In a domestic
environment, this device can cause radio interference, in which case, you need to take
measures to mitigate the interference.
Keyboard
Description of Change
is no longer displayed in the Supplies entry screen.
Location of Change
Table 1.8 System Keyboard Keys in the Keyboard section in Chapter 1, System Overview
1-2
PN C80670AA
Updates to the DxH 500 Instructions for Use
Aspiration
New/Updated Information
Table 1.8 System Keyboard Keys
Icon
Name
Description
Tab
Moves the cursor from field to field.
Backspace
Moves the cursor back one space and deletes the entered character.
Dash
Enters - as a character.
Point
Enters . as a character.
Language
Keyboard
Selection
Lets you select an on-screen keyboard for the language you choose.
Aspiration
Description of Change
The aspiration volume of a prediluted sample mixture has been updated.
Location of Change
Aspiration section in Chapter 1, System Overview
New/Updated Information
Prediluted sample analysis requires a dilution of 20 μL whole blood in 300 μL of diluent solution. The
aspiration volume of a prediluted sample mixture is 192 μL.
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1-3
1
Updates to the DxH 500 Instructions for Use
Startup
Startup
Description of Change
Password reuse has been added.
Location of Change
Startup section in Chapter 3, Startup and Daily Checks
New/Updated Information
Use your Operator ID and password to log on to the system. If you forget your password, contact
your administrator. You cannot use the last 10 passwords.
Logging On/Logging Off
Description of Change
The initial DxH 500 screen has been updated and the section has been revised with new information
and steps.
Location of Change
Logging On/Logging Off section in Chapter 3, Startup and Daily Checks
New/Updated Information
Logging On/Logging Off
1
1-4
If the instrument is not powered on, press the power button located on the front of the
instrument. The button turns red and the logon screen is displayed after about 30 seconds. The
light turns green when the instrument is ready.
PN C80670AA
Updates to the DxH 500 Instructions for Use
Logging On/Logging Off
2
On the initial DxH 500 screen, select the Operator ID field. When the on-screen keyboard is
displayed, enter your operator ID (minimum of two characters; maximum of eight characters).
3
In the Password field, enter a ten-digit alphanumeric password and select a language, if
required, from the Language drop-down list.
NOTE The system defaults to the last selected language.
4
Select
.
NOTE If the Operator ID does not exist or does not match the password entered, you have five attempts
to log in before being locked out. Password resets are restricted to the Administrator security access
level. Operator passwords must be changed every 90 days.
If the power was lost or the printer was turned off during the printing process, the printer spooler will
be cleared at the first login of the day post power up. This will be logged as a warning event.
If the PRINTER IS STOPPED message occurs, to resume printing, select
Printer) to access the Printer Setup screen.
Select the connected printer > select
>
(Admin
to resume printing.
IMPORTANT Access level must be ADMIN.
PN C80670AA
1-5
1
Updates to the DxH 500 Instructions for Use
Logging On/Logging Off
5
If the system determines that the waste is full, a message is displayed. Select
to
acknowledge the message. To empty the waste and replace the container, see Setting Up or
Replacing Waste Disposal in CHAPTER 9, Setup.
NOTE When setting up the instrument for the first time, the waste is set to full (100%) by default. See
Setting Up or Replacing Waste Disposal in CHAPTER 9, Setup to set up the waste disposal.
6
If the system determines that the reagents need to be replaced, a message is displayed. Select
to acknowledge the message. To replace the reagents, see Setting Up or Replacing
Waste Disposal in CHAPTER 9, Setup.
7
Perform the following preventive maintenance as required by the system (the system sends a
reminder to Logs as a warning):
• Replace the Rinsing Head O-Ring - see Replacing the Rinsing Head O-Ring in Chapter 13,
Replacement/Adjustment Procedures.
NOTE See the complete details on the Logs screen. When the preventive maintenance is complete and
the counters are reset from the Diagnostics screen, no further reminders are logged.
• Lubricate the Pistons - see Lubrication Pos. (Syringe Assembly Piston Lubrication) in Chapter 10,
Troubleshooting.
NOTE The reminder for Lubricate the Pistons gets reset after the successful completion of the
Lubrication preventive maintenance.
8
Perform the following bleach cycle as required by the system (the system displays a message and logs
an event as a warning). Select
to perform the procedure or
to cancel. To perform the
bleach cycle, see Performing a Bleach Cycle in Chapter 12, Cleaning Procedures.
NOTE The Bleach Cycle prompt will display and log the first 10 reminders (the number of reminders is
displayed on the screen). Additional reminders will only be displayed, but not logged. The Bleach
Cycle reminder gets reset after the successful completion of a bleach cycle.
9
Run Daily Checks. See Running Daily Checks.
10 To log out, select
1-6
.
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Updates to the DxH 500 Instructions for Use
Identifying Patient Samples
Identifying Patient Samples
Description of Change
Additional Specimen ID information and a Specimen ID Workflow table have been added.
Location of Change
Identifying Patient Samples section in Chapter 5, Sample Analysis
New/Updated Information
All specimens require a valid specimen ID:
• A specimen ID can be manually entered using the on-screen keyboard, by scanning the barcode
label of a specimen, or by using the auto-incrementing feature. See Setting Up Next Specimen
in CHAPTER 9, Setup. If the specimen ID is not entered and the auto-incrementing feature is not
enabled, the system automatically assigns an instrument-generated auto-sequence number
(AutoSID). See Table 5.1, Specimen ID Workflow.
• A specimen ID must be 1 to 16 characters in length, consist of ASCII-printable characters, and
must not have two or more consecutive spaces between characters. A Specimen ID containing
more than 16 characters will be rejected.
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Updates to the DxH 500 Instructions for Use
Identifying Patient Samples
Table 5.1 Specimen ID Workflow
Auto-Feed SID and Worklist Options
Specimen ID
Auto-Feed SID from Worklist: Enabled
If Auto-Incrementing is enabled/disabled:
Entries on the worklist: Yes
The warning message displays:
Worklist contains entries. Confirm Next Specimen ID
is correct before processing specimen. OK
The Specimen ID is automatically populated with
the first order on the worklist.
Auto-Feed SID from Worklist: Enabled
If Auto-Incrementing is enabled:
Entries on the worklist: No
Specimen ID is automatically populated with the
next auto-incrementing ID.
If Auto-Incrementing is disabled:
The following dialog box is displayed:
• Selecting OK removes the message. The
Specimen ID is populated with the next AutoSID.
• Selecting Cancel removes the message. The
Specimen ID remains blank and sampling is not
permitted.
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Updates to the DxH 500 Instructions for Use
Identifying Patient Samples
Auto-Feed SID and Worklist Options
Specimen ID
Auto-Feed SID from Worklist: Disabled
If Auto-Incrementing is enabled:
Entries on the worklist: Yes
Specimen ID is automatically populated with the
next auto-incrementing ID.
If Auto-Incrementing is disabled:
The following dialog box is displayed:
• Selecting OK removes the message. The
Specimen ID is populated with the next AutoSID.
• Selecting Cancel removes the message. The
Specimen ID remains blank and sampling is not
permitted.
Auto-Feed SID from Worklist: Disabled
If Auto-Incrementing is enabled:
Entries on the worklist: No
Specimen ID is automatically populated with the
next auto-incrementing ID.
If Auto-Incrementing is disabled:
The following dialog box is displayed:
• Selecting OK removes the message. The
Specimen ID is populated with the next AutoSID.
• Selecting Cancel removes the message. The
Specimen ID remains blank and sampling is not
permitted.
NOTE Auto-Feed SID: Lets you enable or disable the Auto-Feed SID from the Worklist option. When enabled
and there are entries in the Worklist, this option allows the Specimen ID field on the Run screen to be
automatically populated with the Specimen ID from the Worklist entries.
Auto-Incrementing SID: See Setting Up Next Specimen in Chapter 9, Setup.
Specimen results identified with an Auto-SID or Auto-Incrementing SID will not be automatically printed
or transmitted.
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Updates to the DxH 500 Instructions for Use
Running Whole-Blood Samples
Running Whole-Blood Samples
Description of Change
The procedure for running whole-blood samples has been updated.
Location of Change
Steps 2 and 3 in the Running Whole-Blood Samples section in Chapter 5, Sample Analysis
New/Updated Information
Running Whole-Blood Samples
Beckman Coulter recommends that:
• You analyze samples within the operational temperature specifications.
• If flags appear, see Flags in CHAPTER 6, Data Review. As with any analysis method in which a
specimen of suspect quality is used, pay particular attention to the results. Review and verify
the accuracy of all flagged results that exceed your laboratory's action limit.
IMPORTANT Specimens that may contain fibrin, cell fragments, or other debris, or have been difficult to
collect such as pediatric or oncology specimens may require special handling.
CAUTION
Risk of erroneous results. The presence of fibrin strands can cause erroneous
results. You must thoroughly inspect the sample for fibrin strands or clots.
CAUTION
Risk of erroneous results. Mix the sample properly according to your laboratory
protocol and tube manufacturer before analysis. To allow for proper mixing, do
not overfill the sample tube.
1
1-10
Select
.
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Updates to the DxH 500 Instructions for Use
Running Whole-Blood Samples
CAUTION
Risk of misidentification. Verify the Specimen ID in the worklist if the worklist
contains entries. Confirm that the Next Specimen ID is correct before the
processing specimen message is displayed.
2
Note the following:
The Specimen ID field will be populated based on the features that are enabled/disabled on the
software (see Table 5.1, Specimen ID Workflow).
3
Identify a sample using one of the following methods:
• If the Next Specimen ID is correct, verify that
is selected and go to the next step.
• If the Next Specimen ID is not correct or entered, scan the specimen tube’s bar code and
verify that
• Select
is selected.
, use the on-screen keyboard to enter the Specimen ID and Test (CD or CBC),
and verify that the Specimen is WB. Select
selection (the probe is extended).
when prompted to confirm your
NOTE A valid specimen ID must be entered to analyze a specimen. If you have set up auto-
incrementing, the Specimen ID field will be automatically populated. If no Specimen ID exists, the
system assigns an AutoSID. The Specimen ID field will be populated based on the features that are
enabled/disabled on the software (see Table 5.1, Specimen ID Workflow).
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Updates to the DxH 500 Instructions for Use
Running Whole-Blood Samples
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
open covers and doors can cause injury. When you operate the instrument, ensure
that all covers and doors are closed.
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
a loose or bent probe can cause injury. If the probe is loose or bent, do not run the
instrument. See Replacing the Aspiration Probe in CHAPTER 13,
Replacement/Adjustment Procedures for information on how to replace the probe
prior to analysis.
WARNING
Risk of injury and/or exposure to biohazardous material if the contents spill out of
the tube. Use caution when handling the tube and hold it securely under the
probe.
4
Mix the whole-blood sample.
5
Carefully remove the cap from the tube.
6
Clean any residual blood from the rim of the tube prior to sample presentation.
WARNING
Risk of injury and/or biohazardous contamination. To avoid being pierced by the
aspiration probe, use caution when presenting samples for analysis during this
procedure.
CAUTION
Risk of erroneous results if the tube is removed while the system is aspirating. Do
not remove the tube until the probe retracts.
1-12
7
Fully immerse the probe into the tube.
8
Press the aspiration plate while holding the tube in place during aspiration. The status LED
flashes red during aspiration indicating that the sample aspiration is in progress.
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Updates to the DxH 500 Instructions for Use
Running Prediluted-Blood Samples
9
Remove the tube from the probe when the status LED turns solid red and the probe has
retracted. A message is displayed on the bottom left of the screen indicating that the Specimen
ID is being analyzed.
10 Recap the tube.
11 Wait for the instrument to process the sample and display the results. The status LED turns
green.
12 Transmit or print the patient results:
• To transmit, select
Data Review.
• To print, select
Review.
>
>
or see Transmitting Patient Results in CHAPTER 6,
or see Printing Patient Results in CHAPTER 6, Data
• To set up auto-transmit and/or auto-print, see Setting UP LIS and Setting Up Printer
Options in CHAPTER 9, Setup. If you have already set up auto-transmit and/or auto-print,
the data is automatically transmitted and/or printed.
Running Prediluted-Blood Samples
Description of Change
The procedure for running prediluted-blood samples has been updated.
Location of Change
Steps 3, 4, 6, and 7 in the Running Prediluted-Blood Samples section in Chapter 5, Sample Analysis
New/Updated Information
Running Prediluted-Blood Samples
The predilute panel on the DxH 500 offers an alternative sample preparation method for samples
that cannot be directly aspirated in a whole-blood mode or for times when very little blood volume
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Updates to the DxH 500 Instructions for Use
Running Prediluted-Blood Samples
is available through collection. The predilute panel is not intended for obtaining results that exceed
the upper limit of the analytical measuring range.
The predilute panel accepts a 1:16 dilution, prepared by mixing 20 μL of whole blood with 300 μL of
diluent. The diluted sample is analyzed using the predilute mode. The instrument reports the final
results and no correction is required.
IMPORTANT Prediluted samples require analysis in the predilute mode and must be analyzed within 15
minutes after preparation.
CAUTION
Risk of erroneous results. Mix the sample properly according to your laboratory
protocol and tube manufacturer before analysis. To allow for proper mixing, do
not overfill the sample tube.
1
Ensure that the sample tube volume exceeds 300 μL to allow enough room for mixing the
blood/diluent solution.
2
Dispense the diluent as described in Diluent Dispense in CHAPTER 10, Troubleshooting.
3
Pipette 20 μL of blood carefully, wiping the removable pipette tip after the sampling, and dispense the
blood into the same tube where the diluent was dispensed.
4
After dispensing the blood sample, perform continuous aspirations/dispenses with the pipette going
back and forth to homogenize the dilution and rinse the inside of the pipette tip.
5
Select
.
CAUTION
Risk of misidentification. Verify the Specimen ID in the worklist if the worklist
contains entries. Confirm that the Next Specimen ID is correct before the
processing specimen message is displayed.
6
Note the following:
• If the worklist does not have any entries or the Auto-Feed SID option (see the IFU, Setting Up
Next Specimen section in Chapter 9, Setup) is disabled, the system displays a warning message:
Specimen ID required. Use Auto-SID?
—
1-14
: Next Specimen ID is blank and the probe does not extend.
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Updates to the DxH 500 Instructions for Use
Running Prediluted-Blood Samples
—
: Next Specimen ID uses Auto-SID and the probe is extended.
Verify that the Next Specimen ID on the bottom right of the screen is correct.
• If the worklist contains entries, the system displays a warning message. Select
.
Verify that the Next Specimen ID on the bottom right side of the screen is correct. The
probe is extended.
7
Identify a sample using one of the following methods:
• If the Next Specimen ID is correct, verify that
is selected and go to the next step.
• If the Next Specimen ID is not correct, scan the specimen tube’s bar code, select
>
to accept the specimen to be processed in pre-dilute mode.
• Select
, use the on-screen keyboard to enter the Specimen ID and Test (CD or CBC),
verify that the Specimen is PD, and select
selection (the probe is extended).
when prompted to confirm your
NOTE A valid specimen ID must be entered to analyze a specimen. If you have set up auto-
incrementing, the Specimen ID field will be automatically populated. If no Specimen ID exists, the
system assigns an AutoSID. The Specimen ID field will be populated based on the features that are
enabled/disabled on the software (see Table 5.1, Specimen ID Workflow).
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Updates to the DxH 500 Instructions for Use
Running Prediluted-Blood Samples
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
open covers and doors can cause injury. When you operate the instrument, ensure
that all covers and doors are closed.
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
a loose or bent probe can cause injury. If the probe is loose or bent, do not run the
instrument. See Replacing the Aspiration Probe in CHAPTER 13,
Replacement/Adjustment Procedures for information on how to replace the probe
prior to analysis.
WARNING
Risk of injury and/or exposure to biohazardous material if the contents spill out of
the tube. Use caution when handling the tube and hold it securely under the
probe.
WARNING
Risk of injury and/or biohazardous contamination. To avoid being pierced by the
aspiration probe, use caution when presenting samples for analysis during this
procedure.
8
Fully immerse the probe into the tube.
CAUTION
Risk of erroneous results if the tube is removed while the system is aspirating. Do
not remove the tube until the probe retracts.
9
Press the aspiration plate while holding the tube in place during aspiration. The status LED
flashes red while the sample aspiration is in progress. A message is displayed on the bottom left
of the screen indicating that the Specimen ID is being analyzed.
10 Remove the tube from the probe when the status LED turns solid red and the probe is fully
retracted.
11 Wait for the instrument to process the sample and display the results. The LED status turns
green.
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Updates to the DxH 500 Instructions for Use
Messages Displayed
12 Transmit or print the patient results:
• To transmit, select
Data Review.
• To print, select
Review.
or see Transmitting Patient Results in CHAPTER 6,
>
>
or see Printing Patient Results in CHAPTER 6, Data
• To set up auto-transmit and/or auto-print, see Setting Up LIS and Setting Up Printer
Options in CHAPTER 9, Setup. If you have already set up auto-transmit and/or auto-print,
the data is automatically transmitted and/or printed.
Messages Displayed
Description of Change
The name of the Flags & Messages box has been changed.
Location of Change
Second sentence in the Messages Displayed section in Chapter 6, Data Review
New/Updated Information
Messages are displayed in the Messages box on the screen and in printouts, and may be accompanied
by flags or codes.
Messages
Description of Change
The box title and the subtitle have been changed on the Sample Analysis-Patient Results screen.
Location of Change
Messages section in Chapter 6, Data Review
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Updates to the DxH 500 Instructions for Use
Definitive Messages
New/Updated Information
Messages are displayed in the Messages box on the Sample Analysis-Patient Results screen.
Messages are generated when specimen results meet certain conditions or an event occurs that may
affect the operation of the system, the quality of results, or when operator intervention is required.
Messages may be accompanied by R (Review) flags, other flags, or codes.
Definitive Messages
Description of Change
The name of the Flags & Messages box has been changed.
Location of Change
Definitive Messages section in Chapter 6, Data Review
New/Updated Information
Definitive messages are displayed in the Messages box. Definitive messages appear based on limits
you have selected as reference intervals or action limits.
Performing a Shutdown
Description of Change
Clarification and additional information for performing a shutdown have been added.
Location of Change
Steps 3 and 6 and an addition of a step 7 in the Performing a Shutdown section in Chapter 8,
Shutdown.
New/Updated Information
Performing a Shutdown
Beckman Coulter recommends performing a shutdown once every 24 hours. Shutdown removes
diluent and replaces it with cleaner for 30 minutes. It also checks the expiration date and volume of
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Updates to the DxH 500 Instructions for Use
Performing a Shutdown
the reagents. If expired or if the volume is low, the system prompts you to replace the reagent, or
to continue and record the expired reagent in the logs.
1
From the main menu, select
2
Select
3
From the Shutdown dialog box, select one of the following:
.
.
• Power Instrument Down After Shutdown- this option has the instrument perform a
shutdown followed by a power down. Additional Time in Cleaner does not apply.
• Perform Daily Checks After Shutdown- this option places the instrument in cleaner for 30
minutes plus the duration indicated in the Additional Time in Cleaner followed by Daily
Checks.
4
Use the keypad to indicate Additional Time in Cleaner (0 to 5 hours and 0 to 59 minutes) for
greater than 30-minute shutdown cycles.
5
Select
6
Select
.
to continue.
NOTE If the Bleach Cycle has not been performed, a warning message appears recommending this
preventive maintenance to be done; along with a dialog box.
7
From the dialog box, select one of the following:
• Perform Shutdown- this option has the instrument perform a shutdown.
• Perform Bleach followed by Shutdown- this option allows the instrument to automatically
perform a bleach cycle then shutdown.
NOTE The bottom left corner of the screen displays Shutdown and a progress bar is shown displaying
time remaining in cleaner. The power button is red for the total duration. If Additional Time in Cleaner
is selected, the progress bar will end after this time.
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Updates to the DxH 500 Instructions for Use
Powering Down
Powering Down
Description of Change
The Powering Down procedure has been updated.
Location of Change
Powering Down section in Chapter 8, Shutdown
New/Updated Information
Powering Down
1
Press the power button for a few seconds to activate a Power Down.
2
Perform one of the following:
• If the system is not in cleaner and the bleach cycle is recommended, the system displays a dialog
box for you to select one of the following options:
— Perform Shutdown - no bleach cycle is performed. A warning reminder is displayed and the
event is logged as a warning. The Shutdown cycle is performed.
— Perform Bleach followed by Shutdown - a bleach cycle is performed followed by a shutdown
and a power down (see the IFU, Performing a Bleach Cycle section in Chapter 12, Cleaning
Procedures).
NOTE The Bleach Cycle prompt will display and log the first 10 reminders (the number of
reminders is displayed on the screen). Additional reminders will only be displayed, but not
logged. The Bleach Cycle reminder gets reset after successful completion of a bleach cycle.
• If the system is already in cleaner, the system displays a message for you to perform a power
down. Select OK to power down the system.
Setting Up Security Access
Description of Change
New security access and password reuse information have been added.
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Updates to the DxH 500 Instructions for Use
Setting Up Security Access
Location of Change
Setting Up Security Access section in Chapter 9, Setup
New/Updated Information
Setting Up Security Access
You must have administrator access to perform this function. Locked accounts can be unlocked by an
administrator resetting the password of the specific user account. If the administrator has set or changed
the password of another user, the password is temporary and the operator is prompted to change the
password when logging on. For information on security access, see Access Levels in APPENDIX A,
Access Levels and Reports.
1
Select
2
On the Security Access Setup screen, select
>
.
information, highlight the user, and select
to add a user OR to edit existing user
.
3
Use the on-screen keyboard to enter or edit the user information on the screen. The Operator
ID must contain a minimum of two characters and a maximum of eight characters, and the
password must contain ten characters (a combination of alphabetic and numeric). You cannot use
the last 10 passwords.
4
Select
when prompted to accept the information.
NOTE To delete the user information, highlight the user and select
select
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. From the warning window,
to delete the user.
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1
Updates to the DxH 500 Instructions for Use
Setting Up Auto Logout
Setting Up Auto Logout
Description of Change
The Setting Up Auto Logout procedure has been updated.
Location of Change
Step 2 and the screen in Step 3 in the Setting Up Auto Logout section in Chapter 9, Setup
New/Updated Information
Setting Up Auto Logout
This setup option requires administrator access for setting up the auto-logout time.
1-22
1
Select
2
From the Auto Logout dialog box, use the on-screen keypad to enter a time value between 1 and
60 minutes. The default is 15 minutes.
>
>
.
PN C80670AA
Updates to the DxH 500 Instructions for Use
Setting Up Next Specimen
3
Select
when prompted to accept the information.
NOTE If the system is inactive for more than the defined time, you are automatically logged out and the
logon screen is displayed as follows:
To log in with a different Operator ID, select
.
Setting Up Next Specimen
Description of Change
The Setting Up Next Specimen procedure has been updated.
Location of Change
Step 3 in the Setting Up Next Specimen section in Chapter 9, Setup
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1
Updates to the DxH 500 Instructions for Use
Setting Up LIS
New/Updated Information
Setting Up Next Specimen
This setup option lets you set the default test CBC or CD and enable or disable the Specimen ID from
automatically incrementing.
1
Select
2
On the Next Specimen Setup screen, select an option for the Default Test from the drop-down
list for both the Open Tube Presentation and the Closed Tube Presentation: CBC or CD.
3
Select one of the following:
>
.
• Activate Auto Incrementing Specimen ID (specify the number from which the autoincrementing Specimen ID will begin)
• Activate Auto Feed SID from Worklist
4
Select
when prompted to accept the information.
Setting Up LIS
Description of Change
The Setting Up LIS procedure has been updated.
Location of Change
NOTE in step 3 in the Setting Up LIS section in Chapter 9, Setup
New/Updated Information
Setting Up LIS
If your instrument is connected to a host computer, you can transmit sample results by using this
feature.
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Updates to the DxH 500 Instructions for Use
Updating the Printer Driver
The host receiver must comply with the ASTM Host Specification for this instrument. See the Host
Transmission Manual listed in Related Documents for more information.
1
Select
2
From the LIS Setup screen, select
3
Use the on-screen keyboard and drop-down lists to enter the Ethernet Communication or Serial
>
.
Communication settings and select
to enter the communication settings.
to accept the information.
NOTE The system will need to be rebooted at the end of this setup for the changes to apply. If you do
not enter any changes and want to return to the LIS Setup screen, select
.
4
Select Enable Host, select either Serial or Ethernet, and enter the Device ID using the on-screen
keyboard.
5
Select Auto Transmit - Patient and select the type of sample from the options to be automatically
transmitted.
6
Select Transmit DIFF Scatterplot and/or Transmit RBC and PLT Histogram.
7
Select
when prompted to confirm your selection.
Updating the Printer Driver
Description of Change
A new section on updating the printer driver has been added.
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1
Updates to the DxH 500 Instructions for Use
Setting Up and Editing Controls
Location of Change
Add after the Setting Up the Admin Printer section in Chapter 9, Setup
New/Updated Information
Updating the Printer Driver
IMPORTANT The printer driver icon
is available at the Administrator and Service security access
levels. However, the procedure to update the printer driver should only be performed by your Beckman
Coulter Service Representative. Contact your local Beckman Coulter Representative if your printer driver
requires an update.
If the Administrator-level user selects
>
, the system prompts the user to insert a USB
flash drive into the instrument’s USB port. DO NOT insert a USB flash drive into the port. Instead, select
Cancel to exit the screen.
Setting Up and Editing Controls
Description of Change
Information about options has been added to the procedure.
Location of Change
Step 2 in the Setting Up and Editing Controls section in Chapter 9, Setup
New/Updated Information
Setting Up and Editing Controls
1
1-26
Select
>
.
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Updates to the DxH 500 Instructions for Use
Removing All Patient Health Information
CAUTION
Risk of erroneous information. Do not use hyphens when entering lot numbers for
Beckman Coulter controls. A hyphen causes the control results to be stored as
patient results.
2
Perform one of the following:
• To add a control file, highlight a blank line, select
, and use the bar-code scanner to
scan the 2D bar code on the Table of Expected Results. To add the information manually,
select
and use the on-screen keyboard (do not use hyphens). Source options include:
— BEC
— Other
— Patient - Selecting Patient lets you set up a patient sample as a control
• To edit a control file, highlight the existing control file, select
screen keyboard to edit the information manually.
3
, and use the on-
Select Auto Transmit to automatically transmit control results to your LIS or Auto Print to
automatically print control results.
NOTE To delete a control file, see Deleting Control Files in Chapter 4, Quality Control.
4
Select
when prompted to confirm your selection.
Removing All Patient Health Information
This option lets you erase all patient health information from storage, including all patient results users,
passwords, and log information, and is restricted to the Administrator security access level.
If the patient health information is erased, the event with the Operator ID is logged. Upon logout, a
temporary password must be obtained from your Beckman Coulter Representative to log in.
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Updates to the DxH 500 Instructions for Use
Event Messages
1
Select Setup >
.
NOTE Continuing this operation will erase all patient data, log information, and user accounts.
2
From the warning window, enter the password and select
and log information OR select Cancel.
to erase all of the patient data, user,
Event Messages
Description of Change
Event message I/O System Error has been changed to Firmware Communication Error and Pre Probe
Rinsing Vacuum Error has been updated. New event message has also been added.
Location of Change
Table 10.3 Event Messages in Chapter 10, Troubleshooting
New/Updated Information
Event Message
Cause/Consequence
Action
Firmware Communication Error
Cause: Internal command error with
FPGA
1. Power OFF the instrument. Wait 5
minutes.
2. Power ON the instrument and log
in.
3. Perform Diluter Reset.
4. If the problem recurs, contact your
Beckman Coulter Representative.
Consequence: The cycle is stopped.
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Updates to the DxH 500 Instructions for Use
Valve Checks (Now Check Valves)
Event Message
Cause/Consequence
Hardware Does Not Match with System Cause: Mismatch between the
Configuration
hardware and system
Consequence: The cycle is refused.
Action
1. Power OFF the instrument.
2. Power ON the instrument and log
in.
3. Perform Diluter Reset.
4. If the problem recurs, contact your
Beckman Coulter Representative.
Cause: Vacuum failure occurred before 1. Perform Diluter Reset from the
the probe rinsing.
Diagnostics screen.
2.
If the problem recurs, contact your
Consequence: Emergency stop occurs.
Beckman Coulter Representative.
Pre Probe Rinse Vacuum Error
Valve Checks (Now Check Valves)
Description of Change
Valve Checks has been changed to Check Valves.
Location of Change
Valve Checks section title and content in Chapter 10, Troubleshooting
New/Updated Information
Check Valves
Check Valves allow access to the valve test display.
1
Select
2
From the Diagnostics - Check Valves screen, select a valve number to turn it ON or OFF.
> Check Valves.
You can select ALL VLs ON to turn all the valves ON or OFF or EV CHASER to turn the valves ON
or OFF in sequence.
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Updates to the DxH 500 Instructions for Use
Running Repeatability
Running Repeatability
Description of Change
A note has been added about running a repeatability cycle if the maximum number of results has
been reached.
Location of Change
Step 5 in the Running Repeatability section in Chapter 11, Quality Assurance.
New/Updated Information
Running Repeatability
1
Ensure you have enough normal whole blood (normal WBC, RBC, and PLT values) from a single
donor for a minimum of ten cycles.
2
Select
3
If existing data is present, from the warning window, select Print repeatability data before
deleting to print and delete the data OR select Delete data without printing to cancel printing
and delete the data.
4
Select
>
>
to confirm your selection and/or delete the data.
NOTE When you select
Select
5
.
, the data is not deleted and the Repeatability screen is displayed.
to delete the current file and run a new repeatability.
Mix the sample, fully immerse the probe into the tube, and press the aspiration plate. Repeat
the process until N = 10. Ensure that the sample is mixed between runs.
NOTE If the maximum number of runs has been reached, you will be prompted to delete the previous
results before continuing with the repeatability process.
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Updates to the DxH 500 Instructions for Use
When, Why, and How to Perform Each Cleaning Procedure
6
Review the results on the screen.
Information Displayed
Description
N
Number of non-excluded runs
Mean
Average of results
2SD
% CV
Coefficient of variation of included results
Minimum
Lowest result
Maximum
Highest result
Range
Difference between the minimum and maximum value of the parameter
result
7
Verify that the CV or SD does not exceed the established Repeatability limits. See Repeatability
in Chapter 1, System Overview.
8
If the results fail, see Quality Assurance Troubleshooting in Chapter 10, Troubleshooting.
9
Print the results in one of the following ways:
• To autoprint, see Setting Up Printer Options in Chapter 9, Setup.
• To manually print, select
>
, select Selected Result or All Results, and select
to confirm your selection.
When, Why, and How to Perform Each Cleaning Procedure
Description of Change
A new frequency for performing a bleach cycle has been added.
Location of Change
Table 12.1 Matrix of Frequency for Cleaning Procedures in Chapter 12, Cleaning Procedures
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1
Updates to the DxH 500 Instructions for Use
Access Levels
New/Updated Information
Table 12.1 Matrix of Frequency for Cleaning Procedures
Procedure
Purpose
Tools/Supplies
Frequency
Performing a Bleach
Cycle
To remove clogs
• High-quality,
fragrance-free, gelfree bleach (3.6%
solution of sodium
hypochlorite available chlorine)
• Deionized water
• Container for bleachdeionized water
solution
• Container for
deionized water
Every 1,000 cycles or
monthly, whichever
comes first; or as needed
for troubleshooting
purposes
Access Levels
Description of Change
Clarification about access levels for the Calibration RUN feature has been added to Table A.1
Security Access Levels. A new Reset Counters feature has also been added for Diagnostics.
Location of Change
Table A.1 Security Access Levels
New/Updated Information
1-32
Feature
Operator
Administrator
Calibration
Y
Y
Run
N
Y
Display
Y
Y
Cal Factors
N
Y
Finish
N
Y
Setup
N
Y
Edit
N
Y
Diagnostics
Y
Y
Reset Counters
Y
Y
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Updates to the DxH 500 Instructions for Use
Reports
Reports
Description of Change
The reports in Figures A.1 Patient Results - CBC, Whole Blood - Format 1; A.2 Patient Results - CD,
Whole Blood - Format 2; and A.3 Patient Results - CD, Prediluted Blood - Format 1 have been revised.
Location of Change
Reports section in Appendix A, Access Levels and Reports
New/Updated Information
Figure A.1 Patient Results - CBC, Whole Blood - Format 1
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1-33
1
Updates to the DxH 500 Instructions for Use
Reports
Figure A.2 Patient Results - CD, Whole Blood - Format 2
1-34
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Updates to the DxH 500 Instructions for Use
Bar-Code Label Specifications
Figure A.3 Patient Results - CD, Prediluted Blood - Format 1
Bar-Code Label Specifications
Description of Change
Information has been added about characters and Specimen ID.
Location of Change
The third paragraph in the Bar-Code Label Specifications section in Appendix B, Bar Codes.
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1
Updates to the DxH 500 Instructions for Use
Bar-Code Label Specifications
New/Updated Information
The handheld bar-code scanner scans the number of characters in the symbology used plus a check
digit.
By default, the bar-code scanner contains the configuration.
The supported specimen bar-code symbologies are Code 128, Codabar, NW7, Code 39, and
Interleaved 2 of 5. The bar-code scanner can read up to 16 characters or the total number of
characters that can be printed in the viewable height, whichever is less. If more than 16 characters
exist, the specimen ID will be rejected.
1-36
PN C80670AA
CHAPTER 2
Updates to the DxH 520 Instructions for Use
Overview
This chapter describes the updates to your Instructions for Use (IFU) for the DxH 520 (see Related
Documents for the IFU part number).
Keep this addendum with your current documentation.
Safety Notice
Description of Change
The Electromagnetic Compatibility (EMC) Information section has been updated.
Location of Change
Electromagnetic Compatibility (EMC) Information section in the Safety Notice
New/Updated Information
Electromagnetic Compatibility (EMC)
This device complies with the emissions and immunity requirements as specified in the EN/IEC
61326 series of Product Family Standards for a “basic electromagnetic environment.” Such
equipment is supplied directly at low voltage from public mains network. This equipment is not
intended for residential use.
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2-1
Updates to the DxH 520 Instructions for Use
Keyboard
IMPORTANT This device generates, uses, and can radiate unintentional radio-frequency (RF) energy. If this
device is not installed and operated correctly, this RF energy can cause interference with other
equipment. It is the responsibility of the end user to be sure that a compatible electromagnetic
environment for the device can be maintained so that the device operates as intended. This equipment
is designed for use in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT. It is likely to perform
incorrectly if used in a HOME HEALTHCARE ENVIRONMENT. If it is suspected that performace is affected
by electromagnetic interference, correct operation may be restored by increasing the distance between
the equipment and the source of the interference.
In addition, other equipment can radiate RF energy to which this device is sensitive. If one suspects
interference between this device and other equipment, Beckman Coulter recommends the
following actions to correct the interference:
• Evaluate the electromagnetic environment before installation and operation of this device.
• Do not operate this device close to sources of strong electromagnetic radiation (for example:
unshielded intentional RF sources), as these can interfere with proper operation. Examples of
unshielded intentional radiators are handheld radio transmitters, cordless phones, and cellular
phones.
• Do not place this device near medical electrical equipment that can be susceptible to
malfunctions caused by close-proximity to electromagnetic fields.
• This device has been designed and tested to CISPR 11, Class A emission limits. In a domestic
environment, this device can cause radio interference, in which case, you need to take
measures to mitigate the interference.
Keyboard
Description of Change
is no longer displayed in the Supplies entry screen.
Location of Change
Table 1.8 System Keyboard Keys in the Keyboard section in Chapter 1, System Overview
2-2
PN C80670AA
Updates to the DxH 520 Instructions for Use
Aspiration
New/Updated Information
Table 1.8 System Keyboard Keys
Icon
Name
Description
Tab
Moves the cursor from field to field.
Backspace
Moves the cursor back one space and deletes the entered character.
Dash
Enters - as a character.
Point
Enters . as a character.
Language
Keyboard
Selection
Lets you select an on-screen keyboard for the language you choose.
Aspiration
Description of Change
The aspiration volume of a prediluted sample mixture has been updated.
Location of Change
Aspiration section in Chapter 1, System Overview
New/Updated Information
Prediluted sample analysis requires a dilution of 20 μL whole blood in 300 μL of diluent solution. The
aspiration volume of a prediluted sample mixture is 224 μL.
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2
Updates to the DxH 520 Instructions for Use
Startup
Startup
Description of Change
Password reuse has been added.
Location of Change
Startup section in Chapter 3, Startup and Daily Checks
New/Updated Information
Use your Operator ID and password to log on to the system. If you forget your password, contact
your administrator. You cannot use the last 10 passwords.
Logging On/Logging Off
Description of Change
The initial DxH 520 screen has been updated and the section has been revised with new information
and steps.
Location of Change
Logging On/Logging Off section in Chapter 3, Startup and Daily Checks
New/Updated Information
Logging On/Logging Off
1
2-4
If the instrument is not powered on, press the power button located on the front of the
instrument. The button turns red and the logon screen is displayed after about 30 seconds. The
light turns green when the instrument is ready.
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Updates to the DxH 520 Instructions for Use
Logging On/Logging Off
2
On the initial DxH 520 screen, select the Operator ID field. When the on-screen keyboard is
displayed, enter your operator ID (minimum of two characters; maximum of eight characters).
3
In the Password field, enter a ten-digit alphanumeric password and select a language, if
required, from the Language drop-down list.
NOTE The system defaults to the last selected language.
4
Select
.
NOTE If the Operator ID does not exist or does not match the password entered, you have five attempts
to log in before being locked out. Password resets are restricted to the Administrator security access
level. Operator passwords must be changed every 90 days.
If the power was lost or the printer turned off during the printing process, the printer spooler will be
cleared at the first login of the day post power up. This will be logged as a warning event.
If the PRINTER IS STOPPED message occurs, to resume printing, select
Printer) to access the Printer Setup screen.
Select the connected printer > select
>
(Admin
to resume printing.
IMPORTANT Access level must be ADMIN.
PN C80670AA
2-5
2
Updates to the DxH 520 Instructions for Use
Logging On/Logging Off
5
If the system determines that the waste is full, a message is displayed. Select
to
acknowledge the message. To empty the waste and replace the container, see Setting Up or
Replacing Waste Disposal in CHAPTER 9, Setup.
NOTE When setting up the instrument for the first time, the waste is set to full (100%) by default. See
Setting Up or Replacing Waste Disposal in CHAPTER 9, Setup to set up the waste disposal.
6
If the system determines that the reagents need to be replaced, a message is displayed. Select
to acknowledge the message. To replace the reagents, see Setting Up or Replacing
Waste Disposal in CHAPTER 9, Setup.
7
Perform the following preventive maintenance as required by the system (the system sends a
reminder to Logs as a warning):
• Clean the WBC Bath Filer - see Cleaning the WBC Bath Filter in Chapter 12, Cleaning Procedures
as well as Cleaning the WBC Bath Filter in this chapter.
• Replace the Rinsing Head O-Ring - see Replacing the Rinsing Head O-Ring in Chapter 13,
Replacement/Adjustment Procedures.
NOTE See the complete details on the Logs screen. When the preventive maintenance is complete and
the counters are reset from the Diagnostics screen, no further reminders are logged.
• Lubricate the Pistons - see Lubrication Pos. (Syringe Assembly Piston Lubrication) in Chapter 10,
Troubleshooting.
NOTE The reminder for Lubricate the Pistons gets reset after the successful completion of the
Lubrication preventive maintenance.
8
Perform the following bleach cycle as required by the system (the system displays a message and logs
an event as a warning). Select
to perform the procedure or
to cancel. To perform the
bleach cycle, see Performing a Bleach Cycle in Chapter 12, Cleaning Procedures.
NOTE The Bleach Cycle prompt will display and log the first 10 reminders (the number of reminders is
displayed on the screen). Additional reminders will only be displayed, but not logged. The Bleach
Cycle reminder gets reset after the successful completion of a bleach cycle.
9
2-6
Run Daily Checks. See Running Daily Checks.
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Updates to the DxH 520 Instructions for Use
Identifying Patient Samples
10 To log out, select
.
Identifying Patient Samples
Description of Change
Additional Specimen ID information and a Specimen ID Workflow table have been added.
Location of Change
Identifying Patient Samples section in Chapter 5, Sample Analysis
New/Updated Information
All specimens require a valid specimen ID:
• A specimen ID can be manually entered using the on-screen keyboard, by scanning the barcode
label of a specimen, or by using the auto-incrementing feature. See Setting Up Next Specimen
in CHAPTER 9, Setup. If the specimen ID is not entered and the auto-incrementing feature is not
enabled, the system automatically assigns an instrument-generated auto-sequence number
(AutoSID). See Table 5.1, Specimen ID Workflow.
• A specimen ID must be 1 to 16 characters in length, consist of ASCII-printable characters, and
must not have two or more consecutive spaces between characters. A Specimen ID containing
more than 16 characters will be rejected.
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2
Updates to the DxH 520 Instructions for Use
Identifying Patient Samples
Table 5.1 Specimen ID Workflow
Auto-Feed SID and Worklist Options
Specimen ID
Auto-Feed SID from Worklist: Enabled
If Auto-Incrementing is enabled/disabled:
Entries on the worklist: Yes
The warning message displays:
Worklist contains entries. Confirm Next Specimen ID
is correct before processing specimen. OK
The Specimen ID is automatically populated with
the first order on the worklist.
Auto-Feed SID from Worklist: Enabled
If Auto-Incrementing is enabled:
Entries on the worklist: No
Specimen ID is automatically populated with the
next auto-incrementing ID.
If Auto-Incrementing is disabled:
The following dialog box is displayed:
• Selecting OK removes the message. The
Specimen ID is populated with the next AutoSID.
• Selecting Cancel removes the message. The
Specimen ID remains blank and sampling is not
permitted.
2-8
PN C80670AA
Updates to the DxH 520 Instructions for Use
Identifying Patient Samples
Auto-Feed SID and Worklist Options
Specimen ID
Auto-Feed SID from Worklist: Disabled
If Auto-Incrementing is enabled:
Entries on the worklist: Yes
Specimen ID is automatically populated with the
next auto-incrementing ID.
If Auto-Incrementing is disabled:
The following dialog box is displayed:
• Selecting OK removes the message. The
Specimen ID is populated with Auto-SID.
• Selecting Cancel removes the message. The
Specimen ID remains blank and sampling is not
permitted.
Auto-Feed SID from Worklist: Disabled
If Auto-Incrementing is enabled:
Entries on the worklist: No
Specimen ID is automatically populated with the
next auto-incrementing ID.
If Auto-Incrementing is disabled:
The following dialog box is displayed:
• Selecting OK removes the message. The
Specimen ID is populated with the next AutoSID.
• Selecting Cancel removes the message. The
Specimen ID remains blank and sampling is not
permitted.
NOTE Auto-Feed SID: Lets you enable or disable the Auto-Feed SID from the Worklist option. When enabled
and there are entries in the Worklist, this option allows the Specimen ID field on the Run screen to be
automatically populated with the Specimen ID from the Worklist entries.
Auto-Incrementing SID: See Setting Up Next Specimen in Chapter 9, Setup.
Specimen results identified with an Auto-SID or Auto-Incrementing SID will not be automatically printed
or transmitted.
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2
Updates to the DxH 520 Instructions for Use
Running Whole-Blood Samples in Closed-Vial Mode
Running Whole-Blood Samples in Closed-Vial Mode
Description of Change
The procedure for running whole-blood samples in closed-vial mode has been updated.
Location of Change
Steps 2 and 3 in the Running Whole-Blood Samples in Closed-Vial Mode section in Chapter 5, Sample
Analysis
2-10
PN C80670AA
Updates to the DxH 520 Instructions for Use
Running Whole-Blood Samples in Closed-Vial Mode
New/Updated Information
Running Whole-Blood Samples in Closed-Vial Mode
IMPORTANT Specimens that may contain fibrin, cell fragments, or other debris, or have been difficult to
collect such as pediatric or oncology specimens may require special handling.
CAUTION
Risk of erroneous results. The presence of fibrin strands can cause erroneous
results. You must thoroughly inspect the sample for fibrin strands or clots.
CAUTION
Risk of erroneous results. Mix the sample properly according to your laboratory
protocol and tube manufacturer before analysis. To allow for proper mixing, do
not overfill the sample tube.
CAUTION
Possible specimen leakage or clogging of the system can occur. Excessive piercing
of sample tubes may cause coring of the stopper. The number of pierces without
problems can vary among sample tube types and manufacturers. Do not pierce a
blood collection tube more than four times.
Verify the Instructions for Use in the Hematology Tube List (see Related
Documents for more information). Some tubes have more restrictive instructions
for use and limitations on the number of pierces.
CAUTION
Risk of erroneous results. All tubes should contain a minimum volume of 1 mL for
collection devices with greater than 1 mL fill volume or 3/4 the fill volume for
devices with less than 1 mL fill volume. Insufficient volume results in increased
risk of erroneous results.
1
Select
.
CAUTION
Risk of misidentification. Verify the Specimen ID in the worklist if the worklist
contains entries. Confirm that the Next Specimen ID is correct before the
processing specimen message is displayed.
2
PN C80670AA
Note the following:
2-11
2
Updates to the DxH 520 Instructions for Use
Running Whole-Blood Samples in Closed-Vial Mode
The Specimen ID field will be populated based on the features that are enabled/disabled on the
software (see Table 5.1, Specimen ID Workflow).
3
Identify a sample using one of the following methods:
• If the Next Specimen ID is not correct or entered, scan the specimen tube’s bar code and the
default test is assigned (see Setting Up Next Specimen in CHAPTER 9, Setup).
• Select
, use the on-screen keyboard to enter the Specimen ID and Test (CD or CBC),
and verify that the Specimen is WB and CP is selected. Select
confirm your selection. The door automatically opens.
when prompted to
NOTE A valid specimen ID must be entered to analyze a specimen. If you have set up auto-
incrementing, the Specimen ID field will be automatically populated. If no Specimen ID exists, the
system assigns an AutoSID. The Specimen ID field will be populated based on the features that are
enabled/disabled on the software (see Table 5.1, Specimen ID Workflow).
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
open covers and doors can cause injury. When you operate the instrument, ensure
that all covers and doors are closed.
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
a loose or bent probe can cause injury. If the probe is loose or bent, do not run the
instrument. See Replacing the Aspiration Probe in CHAPTER 13,
Replacement/Adjustment Procedures for information on how to replace the probe
prior to analysis.
WARNING
Risk of injury and/or exposure to biohazardous material if the contents spill out of
the tube. Use caution when handling the tube.
2-12
4
Mix the whole-blood sample.
5
Fully insert the sample into the tube holder.
PN C80670AA
Updates to the DxH 520 Instructions for Use
Running Whole-Blood Samples in Closed-Vial Mode
CAUTION
Risk of misleading results and instrument damage if the sample trap door is
opened before the sample analysis is completed. Do not open the sample trap
door. The sample trap door opens automatically.
CAUTION
Risk of instrument damage. If the diluter door is opened when the sample trap
door is open, the instrument may be damaged. Before opening the diluter door,
verify that the sample trap door is closed.
IMPORTANT If you manually close the door, a cycle will not be initiated. To re-open the door, select
.
6
Select
and the door automatically closes. The status LED flashes red during aspiration
and turns to solid red throughout processing. A message in the bottom left corner of the screen
indicates the Specimen ID being analyzed.
When the process is complete, the door automatically opens. The status LED turns green and
the results are displayed.
7
Remove the tube from the tube holder.
8
Transmit or print the patient results:
• To transmit, select
Data Review.
• To print, select
Review.
>
>
or see Transmitting Patient Results in CHAPTER 6,
or see Printing Patient Results in CHAPTER 6, Data
• To set up auto-transmit and/or auto-print, see Setting Up LIS and Setting Up Printer
Options in CHAPTER 9, Setup. If you have already set up auto-transmit and/or auto-print,
the data is automatically transmitted and/or printed.
PN C80670AA
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2
Updates to the DxH 520 Instructions for Use
Running Whole-Blood Samples in Open-Vial Mode
Running Whole-Blood Samples in Open-Vial Mode
Description of Change
The procedure for running whole-blood samples in open-vial mode has been updated.
Location of Change
Steps 2 and 3 in the Running Whole-Blood Samples in Open-Vial Mode section in Chapter 5, Sample
Analysis
New/Updated Information
Running Whole-Blood Samples in Open-Vial Mode
The open-vial mode on the DxH 520 offers an alternative method for processing samples with lower
volumes or samples with tube caps that cannot be pierced.
All test orders entered in the worklist are defaulted to closed-vial mode. To process open-vial
samples, the correct mode needs to be selected.
IMPORTANT Specimens that may contain fibrin, cell fragments, or other debris, or have been difficult to
collect such as pediatric or oncology specimens may require special handling.
CAUTION
Risk of erroneous results. Mix the sample properly according to your laboratory
protocol and tube manufacturer before analysis. To allow for proper mixing, do
not overfill the sample tube.
CAUTION
Risk of erroneous results. The presence of fibrin strands can cause erroneous
results. You must thoroughly inspect the sample for fibrin strands or clots.
1
2-14
Select
.
PN C80670AA
Updates to the DxH 520 Instructions for Use
Running Whole-Blood Samples in Open-Vial Mode
CAUTION
Risk of misidentification. Verify the Specimen ID in the worklist if the worklist
contains entries. Confirm that the Next Specimen ID is correct before the
processing specimen message is displayed.
2
Note the following:
The Specimen ID field will be populated based on the features that are enabled/disabled on the
software (see Table 5.1, Specimen ID Workflow).
3
Identify a sample using one of the following methods:
>
• If the Next Specimen ID is correct, select
processed in open-vial mode (the probe is extended).
to accept the specimen to be
• If the Next Specimen ID is not correct or entered, scan the specimen tube’s bar code, select
>
extended).
• Select
to accept the specimen to be processed in open-vial mode (the probe is
and use the on-screen keyboard to enter the Specimen ID, verify the Test (CD
or CBC), and verify that the Specimen is WB and OV is selected. Select
prompted to confirm your selection (the probe is extended).
, when
NOTE A valid Specimen ID must be entered to analyze a specimen. If you have set up auto-
incrementing, the Specimen ID field will be automatically populated. If no Specimen ID exists, the
system assigns an AutoSID. The Specimen ID field will be populated based on the features that are
enabled/disabled on the software (see Table 5.1, Specimen ID Workflow).
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2
Updates to the DxH 520 Instructions for Use
Running Whole-Blood Samples in Open-Vial Mode
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
open covers and doors can cause injury. When you operate the instrument, ensure
that all covers and doors are closed.
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
a loose or bent probe can cause injury. If the probe is loose or bent, do not run the
instrument. See Replacing the Aspiration Probe in CHAPTER 13,
Replacement/Adjustment Procedures for information on how to replace the probe
prior to analysis.
WARNING
Risk of injury and/or exposure to biohazardous material if the contents spill out of
the tube. Use caution when handling the tube.
4
Mix the whole-blood sample.
5
Carefully remove the cap from the tube.
6
Clean any residual blood from the rim of the tube before presenting the sample.
WARNING
Risk of injury and/or biohazardous contamination. The aspiration probe is sharp.
To avoid being pierced by the aspiration probe, use caution when presenting
samples for analysis during this procedure.
CAUTION
Risk of erroneous results if in open-vial mode if the tube is removed while the
system is aspirating. Do not remove the tube until the probe retracts.
2-16
7
Fully immerse the probe into the tube and select
to analyze the sample. The status LED
flashes red during aspiration indicating that the sample aspiration is in progress.
8
Remove the tube from the probe when the status LED turns solid red and the probe is fully
retracted. A message is displayed on the bottom left of the screen indicating that the Specimen
ID is being analyzed.
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Updates to the DxH 520 Instructions for Use
Running Prediluted-Blood Samples
9
Recap the tube.
10 Wait for the instrument to process the sample and display the results. The status LED turns
green.
11 Transmit or print the patient results:
• To transmit, select
Data Review.
• To print, select
Review.
>
>
or see Transmitting Patient Results in CHAPTER 6,
or see Printing Patient Results in CHAPTER 6, Data
• To set up auto-transmit and/or auto-print, see Setting Up LIS and Setting Up Printer
Options in CHAPTER 9, Setup. If you have already set up auto-transmit and/or auto-print,
the data is automatically transmitted and/or printed.
Running Prediluted-Blood Samples
Description of Change
The procedure for running prediluted-blood samples has been updated.
Location of Change
Steps 3, 4, 6, and 7 in the Running Prediluted-Blood Samples section in Chapter 5, Sample Analysis
New/Updated Information
Running Prediluted-Blood Samples
The predilute panel on the DxH 520 offers an alternative sample preparation method for samples
that cannot be directly aspirated in a whole-blood mode or for times when very little blood volume
is available through collection. The predilute panel is not intended for obtaining results that exceed
the upper limit of the analytical measuring range.
The predilute panel accepts a 1:16 dilution, prepared by mixing 20 μL of whole blood with 300 μL of
diluent. The diluted sample is analyzed using the predilute mode. The instrument reports the final
results and no correction is required.
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2
Updates to the DxH 520 Instructions for Use
Running Prediluted-Blood Samples
IMPORTANT Prediluted samples require analysis in the predilute mode and must be analyzed within 15
minutes after preparation.
CAUTION
Risk of erroneous results. Mix the sample properly according to your laboratory
protocol and tube manufacturer before analysis. To allow for proper mixing, do
not overfill the sample tube.
1
Ensure that the sample tube volume exceeds 300 μL to allow enough room for mixing the
blood/diluent solution.
2
Dispense the diluent as described in Diluent Dispense in CHAPTER 10, Troubleshooting.
3
Pipette 20 μL of blood carefully, wiping the removable pipette tip after the sampling, and dispense the
blood into the same tube where the diluent was dispensed.
4
After dispensing the blood sample, perform continuous aspirations/dispenses with the pipette going
back and forth to homogenize the dilution and rinse the inside of the pipette tip.
5
Select
.
CAUTION
Risk of misidentification. Verify the Specimen ID in the worklist if the worklist
contains entries. Confirm that the Next Specimen ID is correct before the
processing specimen message is displayed.
6
Note the following:
• If the worklist does not have any entries or the Auto-Feed SID option (see the IFU, Setting Up
Next Specimen section in Chapter 9, Setup) is disabled, a warning message is displayed:
Specimen ID required. Use Auto-SID?
—
—
2-18
: Next Specimen ID is blank and sampling is not permitted.
: Next Specimen ID uses Auto-SID and the door automatically opens. Verify that
the Next Specimen ID on the botton right side of the screen is correct.
PN C80670AA
Updates to the DxH 520 Instructions for Use
Running Prediluted-Blood Samples
• If the worklist contains entries, the system displays a warning message. Select
Verify that the Next Specimen ID on the bottom right side of the screen is correct.
7
.
Identify a sample using one of the following methods:
• If the Next Specimen ID is correct, select
pre-dilute mode (the probe is extended).
• If the Next Specimen ID is not correct, select
code, select
>
(the probe is extended).
• Select
to accept the specimen to be processed in
, if applicable, and scan the tube’s bar
to accept the specimen to be processed in pre-dilute mode,
, use the on-screen keyboard to enter the Specimen ID and Test (CD or CBC),
and verify that the Specimen is PD. Select
selection (the probe is extended).
when prompted to confirm your
NOTE A valid specimen ID must be entered to analyze a specimen. If you have set up auto-
incrementing, the Specimen ID field will be automatically populated. If no Specimen ID exists, the
system assigns an AutoSID. The Specimen ID field will be populated based on the features that are
enabled/disabled on the software (see Table 5.1, Specimen ID Workflow).
PN C80670AA
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2
Updates to the DxH 520 Instructions for Use
Running Prediluted-Blood Samples
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
open covers and doors can cause injury. When you operate the instrument, ensure
that all covers and doors are closed.
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
a loose or bent probe can cause injury. If the probe is loose or bent, do not run the
instrument. See Replacing the Aspiration Probe in CHAPTER 13,
Replacement/Adjustment Procedures for information on how to replace the probe
prior to analysis.
WARNING
Risk of injury and/or exposure to biohazardous material if the contents spill out of
the tube. Use caution when handling the tube.
WARNING
Risk of injury and/or biohazardous contamination. The aspiration probe is sharp.
To avoid being pierced by the aspiration probe, use caution when presenting
samples for analysis during this procedure.
CAUTION
Risk of erroneous results if in open-vial mode if the tube is removed while the
system is aspirating. Do not remove the tube until the probe retracts.
8
Fully immerse the probe into the tube and select
to analyze the sample. A message is
displayed on the bottom left of the screen indicating that the Specimen ID is being analyzed.
9
Remove the tube from the probe when the status LED turns solid red and the probe is fully
retracted.
10 Wait for the instrument to process the sample and display the results. The LED status turns
green.
2-20
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Updates to the DxH 520 Instructions for Use
Messages Displayed
11 Transmit or print the patient results:
• To transmit, select
Data Review.
• To print, select
Review.
>
>
or see Transmitting Patient Results in CHAPTER 6,
or see Printing Patient Results in CHAPTER 6, Data
• To set up auto-transmit and/or auto-print, see Setting Up LIS and Setting Up Printer
Options in CHAPTER 9, Setup. If you have already set up auto-transmit and/or auto-print,
the data is automatically transmitted and/or printed.
Messages Displayed
Description of Change
The name of the Flags & Messages box has been changed.
Location of Change
Second sentence in the Messages Displayed section in Chapter 6, Data Review.
New/Updated Information
Messages are displayed in the Messages box on the screen and in printouts, and may be accompanied
by flags or codes.
Messages
Description of Change
The box title and the subtitle have been changed on the Sample Analysis-Patient Results screen.
Location of Change
Messages section in Chapter 6, Data Review in the IFU.
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Updates to the DxH 520 Instructions for Use
Definitive Messages
New/Updated Information
Messages are displayed in the Messages box on the Sample Analysis-Patient Results screen.
Messages are generated when specimen results meet certain conditions or an event occurs that may
affect the operation of the system, the quality of results, or when operator intervention is required.
Messages may be accompanied by R (Review) flags, other flags, or codes.
Definitive Messages
Description of Change
The name of the Flags & Messages box has been changed.
Location of Change
Definitive Messages section in Chapter 6, Data Review
New/Updated Information
Definitive messages are displayed in the Messages box. Definitive messages appear based on limits
you have selected as reference intervals or action limits.
Performing a Shutdown
Description of Change
Clarification and additional information for performing a shutdown have been added.
Location of Change
Steps 3 and 6 and an addition of a step 7 in the Performing a Shutdown section in Chapter 8,
Shutdown
New/Updated Information
Performing a Shutdown
Beckman Coulter recommends performing a shutdown once every 24 hours. Shutdown removes
diluent and replaces it with cleaner for 30 minutes. It also checks the expiration date and volume of
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Updates to the DxH 520 Instructions for Use
Performing a Shutdown
the reagents. If expired or if the volume is low, the system prompts you to replace the reagent, or
to continue and record the expired reagent in the logs.
1
From the main menu, select
2
Select
3
From the Shutdown dialog box, select one of the following:
.
.
• Power Instrument Down After Shutdown- this option has the instrument perform a
shutdown followed by a power down. Additional Time in Cleaner does not apply.
• Perform Daily Checks After Shutdown- this option places the instrument in cleaner for 30
minutes plus the duration indicated in the Additional Time in Cleaner followed by Daily
Checks.
4
Use the keypad to indicate Additional Time in Cleaner (0 to 5 hours and 0 to 59 minutes) for
greater than 30-minute shutdown cycles.
5
Select
6
Select
.
to continue.
NOTE If the Bleach Cycle has not been performed, a warning message appears recommending this
preventive maintenance to be done; along with a dialog box.
7
From the dialog box, select one of the following:
• Perform Shutdown- this option has the instrument perform a shutdown.
• Perform Bleach followed by Shutdown- this option allows the instrument to automatically
perform a bleach cycle then shutdown.
NOTE The bottom left corner of the screen displays Shutdown and a progress bar is shown displaying
time remaining in cleaner. The power button is red for the total duration. If Additional Time in Cleaner
is selected, the progress bar will end after this time.
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Updates to the DxH 520 Instructions for Use
Powering Down
Powering Down
Description of Change
The Powering Down procedure has been updated.
Location of Change
Powering Down section in Chapter 8, Shutdown
New/Updated Information
Powering Down
1
Press the power button for a few seconds to activate a Power Down.
2
Perform one of the following:
• If the system is not in cleaner and the bleach cycle is recommended, the system displays a dialog
box for you to select one of the following options:
— Perform Shutdown - no bleach cycle is performed. A warning reminder is displayed and the
event is logged as a warning. The Shutdown cycle is performed.
— Perform Bleach followed by Shutdown - a bleach cycle is performed followed by a shutdown
and a power down (see the IFU, Performing a Bleach Cycle section in Chapter 12, Cleaning
Procedures).
NOTE The Bleach Cycle prompt will display and log the first 10 reminders (the number of
reminders is displayed on the screen). Additional reminders will only be displayed, but not
logged. The Bleach Cycle reminder gets reset after successful completion of a bleach cycle.
• If the system is already in cleaner, the system displays a message for you to perform a power
down. Select OK to power down the system.
Setting Up Security Access
Description of Change
New security access and password reuse information have been added.
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Updates to the DxH 520 Instructions for Use
Setting Up Security Access
Location of Change
Setting Up Security Access section in Chapter 9, Setup.
New/Updated Information
Setting Up Security Access
You must have administrator access to perform this function. Locked accounts can be unlocked by an
administrator resetting the password of the specific user account. If the administrator has set or changed
the password of another user, the password is temporary and the operator is prompted to change the
password when logging on. For information on security access, see Access Levels in APPENDIX A,
Access Levels and Reports.
1
Select
2
On the Security Access Setup screen, select
>
.
information, highlight the user, and select
to add a user OR to edit existing user
.
3
Use the on-screen keyboard to enter or edit the user information on the screen. The Operator
ID must contain a minimum of two characters and a maximum of eight characters, and the
password must contain ten characters (a combination of alphabetic and numeric). You cannot use
the last 10 passwords.
4
Select
when prompted to accept the information.
NOTE To delete the user information, highlight the user and select
select
PN C80670AA
. From the warning window,
to delete the user.
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2
Updates to the DxH 520 Instructions for Use
Setting Up Auto Logout
Setting Up Auto Logout
Description of Change
The Setting Up Auto Logout procedure has been updated.
Location of Change
Step 2 and the screen in Step 3 in the Setting Up Auto Logout section in Chapter 9, Setup
New/Updated Information
Setting Up Auto Logout
This setup option requires administrator access for setting up the auto-logout time.
2-26
1
Select
2
From the Auto Logout dialog box, use the on-screen keypad to enter a time value between 1 and
60 minutes. The default is 15 minutes.
>
>
.
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Updates to the DxH 520 Instructions for Use
Setting Up Next Specimen
3
Select
when prompted to accept the information.
NOTE If the system is inactive for more than the defined time, you are automatically logged out and the
logon screen is displayed as follows:
To log in with a different Operator ID, select
.
Setting Up Next Specimen
Description of Change
The Setting Up Next Specimen procedure has been updated.
Location of Change
Step 3 in the Setting Up Next Specimen section in Chapter 9, Setup
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Updates to the DxH 520 Instructions for Use
Setting Up LIS
New/Updated Information
Setting Up Next Specimen
This setup option lets you set the default test CBC or CD and enable or disable the Specimen ID from
automatically incrementing.
1
Select
2
On the Next Specimen Setup screen, select an option for the Default Test from the drop-down
list for both the Open Tube Presentation and the Closed Tube Presentation: CBC or CD.
3
Select one of the following:
>
.
• Activate Auto Incrementing Specimen ID (specify the number from which the autoincrementing Specimen ID will begin)
• Activate Auto Feed SID from Worklist
4
Select
when prompted to accept the information.
Setting Up LIS
Description of Change
The Setting Up LIS procedure has been updated.
Location of Change
NOTE in step 3 in the Setting Up LIS section in Chapter 9, Setup
New/Updated Information
Setting Up LIS
If your instrument is connected to a host computer, you can transmit sample results by using this
feature.
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Updates to the DxH 520 Instructions for Use
Updating the Printer Driver
The host receiver must comply with the ASTM Host Specification for this instrument. See the Host
Transmission Manual listed in Related Documents for more information.
1
Select
2
From the LIS Setup screen, select
3
Use the on-screen keyboard and drop-down lists to enter either Ethernet Communication or
>
.
Serial Communication settings and select
to enter the communication settings.
to accept the information.
NOTE The system will need to be rebooted at the end of this setup for the changes to apply. If you do
not enter any changes and want to return to the LIS Setup screen, select
.
4
Select Enable Host > Serial or Ethernet, and enter the Device ID using the on-screen keyboard.
5
Select Auto Transmit - Patient and select the type of sample from the options to be automatically
transmitted.
6
Select Transmit DIFF Scatterplot and/or Transmit RBC and PLT Histogram.
7
Select
when prompted to confirm your selection.
Updating the Printer Driver
Description of Change
A new section on updating the printer driver has been added.
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Updates to the DxH 520 Instructions for Use
Setting Up and Editing Controls
Location of Change
Add after the Setting Up the Admin Printer section in Chapter 9, Setup
New/Updated Information
Updating the Printer Driver
IMPORTANT The printer driver icon
is available at the Administrator and Service security access
levels. However, the procedure to update the printer driver should only be performed by your Beckman
Coulter Service Representative. Contact your local Beckman Coulter Representative if your printer driver
requires an update.
If the Administrator-level user selects
>
, the system prompts the user to insert a USB
flash drive into the instrument’s USB port. DO NOT insert a USB flash drive into the port. Instead, select
Cancel to exit the screen.
Setting Up and Editing Controls
Description of Change
Information about options has been added to the procedure.
Location of Change
Step 2 in the Setting Up and Editing Controls section in Chapter 9, Setup
New/Updated Information
Setting Up and Editing Controls
1
2-30
Select
>
.
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Updates to the DxH 520 Instructions for Use
Removing All Patient Health Information
CAUTION
Risk of erroneous information. Do not use hyphens when entering lot numbers for
Beckman Coulter controls. A hyphen causes the control results to be stored as
patient results.
2
Perform one of the following:
• To add a control file, highlight a blank line, select
, and use the bar-code scanner to
scan the 2D bar code on the Table of Expected Results. To add the information manually,
select
and use the on-screen keyboard (do not use hyphens). Source options include:
— BEC
— Other
— Patient - Selecting Patient lets you set up a patient sample as a control
• To edit a control file, highlight the existing control file, select
screen keyboard to edit the information manually.
3
, and use the on-
Select Auto Transmit to automatically transmit control results to your LIS or Auto Print to
automatically print control results.
NOTE To delete a control file, see Deleting Control Files in Chapter 4, Quality Control.
4
Select
when prompted to confirm your selection.
Removing All Patient Health Information
This option lets you erase all patient health information from storage, including all patient results users,
passwords, and log information, and is restricted to the Administrator security access level.
If the patient health information is erased, the event with the Operator ID is logged. Upon logout, a
temporary password must be obtained from your Beckman Coulter Representative to log in.
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Updates to the DxH 520 Instructions for Use
Event Messages
1
Select Setup >
.
NOTE Continuing this operation will erase all patient data, log information, and user accounts.
2
From the warning window, enter the password and select
and log information OR select Cancel.
to erase all of the patient data, user,
Event Messages
Description of Change
New event messages have been added.
Location of Change
Table 10.3 Event Messages in Chapter 10, Troubleshooting.
New/Updated Information
Event Message
Cause/Consequence
Action
Firmware Communication Error
Cause: Internal command error with
FPGA
1. Power OFF the instrument. Wait 5
minutes.
2. Power ON the instrument and log
in.
3. Perform Diluter Reset.
4. If the problem recurs, contact your
Beckman Coulter Representative.
Consequence: The cycle is stopped.
Hardware Does Not Match with System Cause: Mismatch between the
Configuration
hardware and system
Consequence: The cycle is refused.
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1. Power OFF the instrument.
2. Power ON the instrument and log
in.
3. Perform Diluter Reset.
4. If the problem recurs, contact your
Beckman Coulter Representative.
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Updates to the DxH 520 Instructions for Use
Valve Checks (Now Check Valves)
Valve Checks (Now Check Valves)
Description of Change
Valve Checks has been changed to Check Valves.
Location of Change
Valve Checks section title and content in Chapter 10, Troubleshooting
New/Updated Information
Check Valves
Check Valves allow access to the valve test display.
1
Select
2
From the Diagnostics - Check Valves screen, select a valve number to turn it ON or OFF.
> Check Valves.
You can select ALL VLs ON to turn ON or OFF all valves, EV CHASER to turn the valves ON or OFF
in sequence, or SHEAR VALVE to rotate the shear valve.
Running Repeatability
Description of Change
A note has been added about running a repeatability cycle if the maximum number of results has
been reached.
Location of Change
Step 9 in the Running Repeatability section in Chapter 11, Quality Assurance.
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Updates to the DxH 520 Instructions for Use
Running Repeatability
New/Updated Information
Running Repeatability
1
Ensure you have enough normal whole blood (normal WBC, RBC, and PLT values) from a single
donor for a minimum of ten cycles.
2
Separate the whole-blood sample into three tubes.
NOTE Capped samples cannot be pierced more than four times. When an uncapped whole-blood
sample is processed, separating the blood into three tubes is not necessary.
3
Select
4
If existing data is present, from the warning window, select Print repeatability data before
deleting to print and delete the data OR select Delete data without printing to cancel printing
and delete the data. The door opens after the data has been deleted.
5
Select
>
>
to confirm your selection and/or delete the data.
NOTE When you select
Select
2-34
.
, the data is not deleted and the Repeatability screen is displayed.
to delete the current file and run a new repeatability.
6
Mix the sample.
7
Fully insert the whole blood sample into the tube holder.
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Updates to the DxH 520 Instructions for Use
Running Repeatability
IMPORTANT If you manually close the sample trap door, a cycle is not initiated. To re-open the sample trap
door for the first cycle, restart the procedure. To re-open the sample trap door for any subsequent cycle,
select the run and select
8
>
.
Select
and the sample trap door automatically closes to initiate the analysis. After the
cycle is complete, the sample trap door opens and the result is displayed.
CAUTION
Risk of specimen leakage or clogging. Possible specimen leakage or clogging of
the system can occur. Excessive piercing of sample tubes may cause coring of the
stopper. The number of pierces without problems can vary among sample tube
types and manufacturers. Do not pierce a blood collection tube more than four
times.
Verify the Instructions for Use in the Hematology Tube List (see Related
Documents for more information). Some tubes have more restrictive instructions
for use and limitations on the number of pierces.
9
Complete the required number of replicates (N=10) by selecting
to initiate each run.
Replace each tube after four replicates. Ensure that the sample is mixed between runs.
NOTE If the maximum number of runs has been reached, you will be prompted to delete the previous
results before continuing with the repeatability process.
10 Review the results on the screen.
Information Displayed
Description
N
Number of non-excluded runs
Mean
Average of results
2SD
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% CV
Coefficient of variation of included results
Minimum
Lowest result
Maximum
Highest result
Range
Difference between the minimum and maximum value of the parameter
result
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Updates to the DxH 520 Instructions for Use
When, Why, and How to Perform Each Cleaning Procedure
11 Verify that the CV or SD does not exceed the established Repeatability limits. See Repeatability
in Chapter 1, System Overview.
12 If the results fail, see Quality Assurance Troubleshooting in Chapter 10, Troubleshooting.
13 Print the results in one of the following ways:
• To autoprint, see Setting Up Printer Options in Chapter 9, Setup.
• To manually print, select
>
, select Selected Result or All Results, and select
to confirm your selection.
When, Why, and How to Perform Each Cleaning Procedure
Description of Change
A new frequency for performing a bleach cycle has been added.
Location of Change
Table 12.1 Matrix of Frequency for Cleaning Procedures in Chapter 12, Cleaning Procedures
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Updates to the DxH 520 Instructions for Use
Cleaning the WBC Bath Filter
New/Updated Information
Table 12.1 Matrix of Frequency for Cleaning Procedures
Procedure
Purpose
Tools/Supplies
Frequency
Performing a Bleach
Cycle
To remove clogs
• High-quality,
fragrance-free, gelfree bleach (3.6%
solution of sodium
hypochlorite available chlorine)
• Deionized water
• Container for bleachdeionized water
solution
• Container for
deionized water
Every 1,000 cycles or
monthly, whichever
comes first; or as needed
for troubleshooting
purposes
Cleaning the WBC Bath Filter
Description of Change
A new step for performing the procedure has been added.
Location of Change
Step 1 in Cleaning the WBC Bath Filter in Chapter 12, Cleaning Procedures.
New/Updated Information
Step 1 now includes selecting the Fluidics icon in order to access the Drain Baths function.
PN C80670AA
1
Select
> Fluidics > Drain Baths to drain the baths, vacuum, and waste syringes. When
the power button turns green, go to the next step.
2
Continue steps 2 to 18 as per procedure in IFU.
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2
Updates to the DxH 520 Instructions for Use
Access Levels
Access Levels
Description of Change
Clarification about access levels for the Calibration RUN feature has been added to Table A.1
Security Access Levels. A new Reset Counters feature has also been added.
Location of Change
Table A.1 Security Access Levels
New/Updated Information
Feature
Operator
Administrator
Calibration
Y
Y
Run
N
Y
Display
Y
Y
Cal Factors
N
Y
Finish
N
Y
Setup
N
Y
Edit
N
Y
Diagnostics
Y
Y
Reset Counters
Y
Y
Reports
Description of Change
The reports in Figures A.1 Patient Results - CBC, Whole Blood - Format 1; A.2 Patient Results - CD,
Whole Blood - Format 2; and A.3 Patient Results - CD, Prediluted Blood - Format 1 have been revised.
Location of Change
Reports section in Appendix A, Access Levels and Reports
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Updates to the DxH 520 Instructions for Use
Reports
New/Updated Information
Figure A.1 Patient Results - CBC, Whole Blood - Format 1
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2
Updates to the DxH 520 Instructions for Use
Reports
Figure A.2 Patient Results - CD, Whole Blood - Format 2
2-40
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Updates to the DxH 520 Instructions for Use
Bar-Code Label Specifications
Figure A.3 Patient Results - CD, Prediluted Blood - Format 1
Bar-Code Label Specifications
Description of Change
More information has been added about characters and Specimen ID.
Location of Change
The third paragraph in the Bar-Code Label Specifications section in Appendix B, Bar Codes.
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Updates to the DxH 520 Instructions for Use
Bar-Code Label Specifications
New/Updated Information
The handheld bar-code scanner scans the number of characters in the symbology used plus a check
digit.
By default, the bar-code scanner contains the configuration.
The supported specimen bar-code symbologies are Code 128, Codabar, NW7, Code 39, and
Interleaved 2 of 5. The bar-code scanner can read up to 16 characters or the total number of
characters that can be printed in the viewable height, whichever is less. If more than 16 characters
exist, the specimen ID will be rejected.
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CHAPTER 3
Updates to the DxH 560 Instructions for Use
Overview
This chapter describes the updates to your Instructions for Use (IFU) for the DxH 560 (see Related
Documents for the IFU part number).
Keep this addendum with your current documentation.
Safety Notice
Description of Change
The Electromagnetic Compatibility (EMC) Information section has been updated.
Location of Change
Electromagnetic Compatibility (EMC) Information section in the Safety Notice
New/Updated Information
Electromagnetic Compatibility (EMC)
This device complies with the emissions and immunity requirements as specified in the EN/IEC
61326 series of Product Family Standards for a “basic electromagnetic environment.” Such
equipment is supplied directly at low voltage from public mains network. This equipment is not
intended for residential use.
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Updates to the DxH 560 Instructions for Use
Intended Use
IMPORTANT This device generates, uses, and can radiate unintentional radio-frequency (RF) energy. If this
device is not installed and operated correctly, this RF energy can cause interference with other
equipment. It is the responsibility of the end user to be sure that a compatible electromagnetic
environment for the device can be maintained so that the device operates as intended. This equipment
is designed for use in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT. It is likely to perform
incorrectly if used in a HOME HEALTHCARE ENVIRONMENT. If it is suspected that performace is affected
by electromagnetic interference, correct operation may be restored by increasing the distance between
the equipment and the source of the interference.
In addition, other equipment can radiate RF energy to which this device is sensitive. If one suspects
interference between this device and other equipment, Beckman Coulter recommends the
following actions to correct the interference:
• Evaluate the electromagnetic environment before installation and operation of this device.
• Do not operate this device close to sources of strong electromagnetic radiation (for example:
unshielded intentional RF sources), as these can interfere with proper operation. Examples of
unshielded intentional radiators are handheld radio transmitters, cordless phones, and cellular
phones.
• Do not place this device near medical electrical equipment that can be susceptible to
malfunctions caused by close-proximity to electromagnetic fields.
• This device has been designed and tested to CISPR 11, Class A emission limits. In a domestic
environment, this device can cause radio interference, in which case, you need to take
measures to mitigate the interference.
Intended Use
Description of Change
Prediluted whole blood has been added.
Location of Change
Second paragraph in the Intended Use section in Chapter 1, System Overview
New/Updated Information
The DxH 560 is a quantitative, multi-parameter, automated hematology analyzer with an
autoloader for in vitro diagnostic use in clinical laboratories; including hospital and reference
laboratories. It is used to identify the normal patient with normal system-generated parameters
from patients with abnormal parameters and/or flags that require additional studies.
The DxH 560 identifies and enumerates the following parameters: WBC, RBC, HGB, HCT, MCV, MCH,
MCHC, RDW, RDW-SD, PLT, MPV, LY%, LY#, MO%, MO#, NE%, NE#, EO%, EO#, BA%, BA# in whole-
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Updates to the DxH 560 Instructions for Use
Cassettes
blood samples (venous and capillary) collected in K2 EDTA and K3 EDTA anticoagulants, and
prediluted whole blood.
The instrument is for use in adult and pediatric populations, including neonates.
Cassettes
Description of Change
Information about Type 2 cassettes has been added.
Location of Change
Cassettes section in Chapter 1, System Overview
New/Updated Information
Cassettes
The DxH 560 uses a five-position cassette. Each position contains a clip that holds the tubes
stationary during processing. The bottom of the cassette includes grooves that interlock with the
autoloader to secure the cassette during specimen processing.
Each cassette is identified by five contiguous tube sites using a 2D bar-code label. The cassette also
has a cassette ID label on it and a readable label on top of it.
Figure 1.8 Cassette Types
Table 1.3 Cassette Type and Tubes
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3
Updates to the DxH 560 Instructions for Use
Cassette Labels
Cassette Type
Block
Label Color
Tube Size
Diameter
Aspiration
Depth
Tube Height
(Min to Max*)
1
Black
White
11-13 mm
Full Pierce
65-75 mm
2
Grey
Pink
11-13 mm
Short Pierce,
False Bottom**
65-75 mm
* Tube height minimum is measured from the bottom of the tube to under the cap. The maximum
measurement includes the cap.
** Refer to the DxH 520 & DxH 560 - Hematology Tube List for these specific tubes.
Short-pierce depth tubes include:
• Long false-bottom tubes that fit into the Type 2 cassette
• Smaller length tubes such as 2 mL and 3 mL pediatric sizes processed only in open-vial mode
Specific tube types for Type 1 and Type 2 cassettes are listed in the DxH 520 & DxH 560 - Hematology Tube
List.
Cassette Labels
Description of Change
Information about labels for Type 2 cassettes has been added.
Location of Change
Cassette Labels section in Chapter 1, System Overview
New/Updated Information
Cassette Labels
The cassette labels for Cassette Type 1 (white label) and Cassette Type 2 (pink label) display the following
information:
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Updates to the DxH 560 Instructions for Use
Cassette Labels
Figure 1.10 Cassette Type 1
5
4
B
c
TYPE
NUMBER
01
3
01
2
1
d
Number
Description
1
Type of cassette
See the Hematology Tube List (see Related Documents) for more information on specimen
tubes.
2
Number of the cassette
3
Orientation for placing the cassette in the input area (arrows should point down and to the right)
Figure 1.11 Cassette Type 2
5
4
B
c
TYPE
NUMBER
02
3
01
2
1
d
Number
Description
1
Type of cassette
See the Hematology Tube List (see Related Documents) for more information on specimen
tubes.
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2
Number of the cassette
3
Orientation for placing the cassette in the input area (arrows should point down and to the right)
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3
Updates to the DxH 560 Instructions for Use
Aspiration
Aspiration
Description of Change
Information about prediluted sample has been added.
Location of Change
Aspiration section in Chapter 1, System Overview
New/Updated Information
The volume of whole blood aspirated is approximately 16.7 μL of whole blood in the cassette
presentation or open-vial whole blood analyzing mode. Prediluted sample analysis requires a dilution
of 20 μL whole blood in 300 μL of diluent solution. The aspiration volume of a prediluted sample mixture is
224 μL.
Method Comparison Specifications - Prediluted versus Whole Blood
Description of Change
A new section titled Method Comparison Specifications - Prediluted Versus Whole Blood has been added.
Location of Change
New section to be located before the Repeatability section in Chapter 1, System Overview.
New/Updated Information
Method Comparison Specifications - Prediluted Versus Whole Blood
Diluted samples must be analyzed within 15 minutes of preparation. Results with system messages should
be excluded. Results compared between whole-blood specimens and their prediluted sample on the DxH
560 should agree within the limits defined in Table 1.12, Method Comparison Specifications - Prediluted
Versus Whole Blood.
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Updates to the DxH 560 Instructions for Use
Repeatability
Table 1.12 Method Comparison Specifications - Prediluted Versus Whole Blood
Whole Blood
Parameter
Units
Measuring Range
Difference or %
Difference
(whichever is greater)
WBC
x103 cells/μL
0.20 to 100.00
± 0.60 or ± 10.00%
RBC
x106 cells/μL
0.20 to 8.00
± 0.10 or ± 10.00%
HGB
g/dL
0.20 to 25.00
± 0.40 or ± 6.00%
HCT
%
0.0 to 85.0
± 1.0 or ± 5.0%
MCV
fL
50.0 to 150.0
± 4.0%
MCH
p/g
0.0 to 99.9
± 5.0%
MCHC
g/dL
0.0 to 99.9
± 5.0%
RDW
%
10.0 to 40.0
± 2.0 or ± 5.0%
RDW-SD
fL
15.0 to 150.0
± 7.5 or ± 10.0%
PLT
x103 cells/μL
7.0 to 2000.0
± 20.0 or ± 15.0%
MPV
fL
5.00 to 25.00
± 1.50 or ± 8.00%
LY
%
0.00 to 100.00
± 3.00 or ± 10.00%
MO
%
0.00 to 100.00
± 3.00 or ± 10.00%
NE
%
0.00 to 100.00
± 3.00 or ± 10.00%
EO
%
0.00 to 100.00
± 1.50 or ± 10.00%
BA
%
0.00 to 100.00
± 1.50 or ± 10.00%
LY#
x103 cells/μL
0.00 to 100.00
± 0.30 or ± 10.00%
MO#
x103 cells/μL
0.00 to 100.00
± 0.30 or ± 10.00%
NE#
x103 cells/μL
0.00 to 100.00
± 0.30 or ± 10.00%
EO#
x103 cells/μL
0.00 to 100.00
± 0.20 or ± 10.00%
BA#
x103 cells/μL
0.00 to 100.00
± 0.10 or ± 10.00%
Repeatability
Description of Change
Information about prediluted whole-blood information has been added to the Repeatability Limits
table.
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Updates to the DxH 560 Instructions for Use
Repeatability
Location of Change
Table 1.12 (now Table 1.13) Repeatability Limits in the Repeatability section in Chapter 1, System
Overview.
New/Updated Information
Table 1.13 Repeatability Limits
Parameter
Units
Range*
Repeatability Limits: Repeatability Limits:
Whole Blood
Prediluted Whole
Blood
WBC
x103 cells/μL
0.20 to < 1.00
≤ 0.15 SD
≤ 0.17 SD
1.00 to < 3.00
≤ 0.17 SD
≤ 0.17 SD
3.00 to 5.00
≤ 5.00% CV
≤ 7.00% CV
> 5.00 to 7.00
≤ 4.00% CV
≤ 6.00% CV
> 7.00 to 100.00
≤ 3.00% CV
≤ 5.00% CV
1.00 to < 3.50
≤ 3.00% CV
≤ 5.00% CV
3.50 to 8.00
≤ 2.00% CV
≤ 4.00% CV
3.00 to < 5.00
≤ 4.00% CV
≤ 5.00% CV
5.00 to < 11.00
≤ 2.00% CV
≤ 3.00% CV
 11.00
≤ 1.50% CV
≤ 3.00% CV
RBC
HGB
g/dL
HCT
%
10.0 to 85.0
≤ 3.00% CV
≤ 4.00% CV
MCV
fL
50.0 to 150.0
≤ 1.00% CV
≤ 2.00% CV
MCH
p/g
10.0 to 45.0
≤ 3.00% CV
≤ 4.00% CV
MCHC
g/dL
26.0 to 38.0
≤ 4.00% CV
≤ 5.00% CV
RDW
%
10.0 to 40.0
≤ 3.50% CV
≤ 5.00% CV
RDW-SD
fL
15.0 to 50.0
≤ 3.50% CV
≤ 5.00% CV
PLT
x103 cells/μL
7.0 to < 25.0
≤ 20.00% CV
≤ 25.00% CV
25.0 to 50.0
≤ 15.00% CV
≤ 20.00% CV
> 50.0 to < 100.0
≤ 10.00% CV
≤ 15.00% CV
100.0 to 200.0
≤ 7.50% CV
≤ 12.00% CV
> 200.00 to 2000.0
≤ 5.00% CV
≤ 12.00% CV
5.00 to < 8.00
≤ 2.00% CV
≤ 7.00% CV
 8.00
≤ 3.00% CV
≤ 5.00% CV
1.00 to < 5.00
≤ 0.50 SD
≤ 0.70 SD
5.00 to < 15.00
≤ 12.00% CV
≤ 15.00% CV
15.00 to < 25.00
≤ 10.00% CV
≤ 12.00% CV
25.00 to 50.00
≤ 7.00% CV
≤ 10.00% CV
> 50.00
≤ 5.00% CV
≤ 7.00% CV
MPV
LY
3-8
x106 cells/μL
fL
%
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Updates to the DxH 560 Instructions for Use
Measuring and Operating Ranges, and Linearity
Parameter
Units
Range*
Repeatability Limits: Repeatability Limits:
Whole Blood
Prediluted Whole
Blood
MO
%
1.00 to < 5.00
≤ 1.00 SD
≤ 1.20 SD
5.00 to 10.00
≤ 15.00% CV
≤ 17.00% CV
> 10.00
≤ 10.00% CV
≤ 12.00% CV
5.00 to < 10.00
≤ 20.00% CV
≤ 20.00% CV
10.00 to < 15.00
≤ 12.00% CV
≤ 15.00% CV
15.00 to 50.00
≤ 7.00% CV
≤ 10.00% CV
> 50.00
≤ 5.00% CV
≤ 7.00% CV
1.00 to ≤ 4.99
≤ 0.75 SD
≤ 1.00 SD
5.00 to 10.00
≤ 15.00% CV
≤ 17.00% CV
> 10.00
≤ 12.00% CV
≤ 15.00% CV
NE
EO
%
%
BA
%
 0.01
≤ 1.00 SD
≤ 1.50 SD
LY#
x103 cells/μL
0.20 to < 5.00
≤ 0.50 SD
≤ 0.70 SD
5.00 to < 10.00
≤ 10.00% CV
≤ 12.00% CV
10.00 to 100.00
≤ 7.00% CV
≤ 10.00% CV
0.30 to 3.00
≤ 0.20 SD
≤ 0.30 SD
> 3.00
≤ 7.00% CV
≤ 10.00% CV
0.20 to < 3.00
≤ 0.17 SD
≤ 0.20 SD
3.00 to 7.00
≤ 4.00% CV
≤ 6.00% CV
> 7.00 to 100.00
≤ 3.00% CV
≤ 5.00% CV
0.10 to 5.00
≤ 0.75 SD
≤ 1.00 SD
> 5.00
≤ 1.00 SD
≤ 1.50 SD
 0.01
≤ 1.00 SD
≤ 1.50 SD
MO#
NE#
EO#
BA#
x103 cells/μL
x103 cells/μL
x103 cells/μL
x103 cells/μL
*MPV parameters all apply at PLT > 100.0 x 103 cells/μL. Differential parameters all apply at WBC > 4.00
x 103 cells/μL.
Measuring and Operating Ranges, and Linearity
Description of Change
The terms predilute functionality and prediluted have been added.
Location of Change
Second and last paragraphs in the Measuring and Operating Ranges, and Linearity section in
Chapter 1, System Overview
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Updates to the DxH 560 Instructions for Use
Sample Stability and Storage - Prediluted Whole Blood
New/Updated Information
Measuring range is the set of values of quantities of the same kind that can be measured by a given
measuring instrument or system with specified instrument measurement uncertainty under
defined conditions. The measuring ranges are shown in Table 1.14, Whole Blood Measuring and
Operating Ranges, and Linearity Limits.
Operating range is the range over which the system, including the predilute functionality, reports,
displays, prints, exports, and/or transmits results.
Values that are between the measuring range and operating range are flagged and should not be
reported. These values require additional testing based on the laboratory’s Standard Operating
Procedure (SOP).
Linearity is the ability to provide results that are directly proportional to the concentration of the
analyte in the test sample. Linearity can be assessed by testing levels of an analyte known by
formulation, by using commercially available materials qualified for use on the DxH 560, or
according to CLSI EP06-A22.
The measuring and operating ranges apply to whole-blood and prediluted samples. Linearity limits
apply to whole blood only.
Sample Stability and Storage - Prediluted Whole Blood
Description of Change
A new section titled Sample Stability and Storage - Prediluted Whole Blood has been added.
Location of Change
New section to be located before the Clinical Sensitivity and Specificity section in Chapter 1, System
Overview.
New/Updated Information
Sample Stability and Storage - Prediluted Whole Blood
Prediluted whole-blood samples must be analyzed within 15 minutes of preparation. Whole blood and
diluent should be at room temperature before the dilution is prepared. Prediluted results should agree with
whole-blood results as shown in Table 1.12, Method Comparison Specifications - Prediluted Versus Whole
Blood.
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Updates to the DxH 560 Instructions for Use
Startup
Startup
Description of Change
Password reuse has been added.
Location of Change
Startup section in Chapter 3, Startup and Daily Checks
New/Updated Information
Use your Operator ID and password to log on to the system. If you forget your password, contact
your administrator. You cannot use the last 10 passwords.
Logging On/Logging Off
Description of Change
New information and steps have been added.
Location of Change
Logging On/Logging Off section in Chapter 3, Startup and Daily Checks
New/Updated Information
Logging On/Logging Off
1
PN C80670AA
If the instrument is not powered on, press the power button located on the front of the
instrument. The button turns red and the logon screen is displayed after about 30 seconds. The
light turns green when the instrument is ready.
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3
Updates to the DxH 560 Instructions for Use
Logging On/Logging Off
2
On the initial DxH 560 screen, select the Operator ID field. When the on-screen keyboard is
displayed, enter your operator ID (minimum of two characters; maximum of eight characters).
3
In the Password field, enter a ten-digit alphanumeric password and select a language, if
required, from the Language drop-down list.
NOTE The system defaults to the last selected language.
4
Select
.
NOTE If the Operator ID does not exist or does not match the password entered, you have five attempts
to log in before being locked out. Password resets are restricted to the Administrator security access
level. Operator passwords must be changed every 90 days.
If the power was lost or the printer turned off during the printing process, the printer spooler will be
cleared at the first login of the day post power up. This will be logged as a warning event.
If the PRINTER IS STOPPED message occurs, to resume printing, select
Printer) to access the Printer Setup screen.
Select the connected printer > select
3-12
>
(Admin
to resume printing.
PN C80670AA
Updates to the DxH 560 Instructions for Use
Logging On/Logging Off
IMPORTANT Access level must be ADMIN.
5
If the system determines that the waste is full, a message is displayed. Select
to
acknowledge the message. To empty the waste and replace the container, see Setting Up or
Replacing Waste Disposal in CHAPTER 9, Setup.
NOTE When setting up the instrument for the first time, the waste is set to full (100%) by default. See
Setting Up or Replacing Waste Disposal in CHAPTER 9, Setup to set up the waste disposal.
6
If the system determines that the reagents need to be replaced, a message is displayed. Select
to acknowledge the message. To replace the reagents, see Setting Up or Replacing
Waste Disposal in CHAPTER 9, Setup.
7
Perform the following preventive maintenance as required by the system (the system sends a
reminder to Logs as a warning):
• Clean the WBC Bath Filter - see Cleaning the WBC Bath Filter in Chapter 12, Cleaning Procedures
as well as Cleaning the WBC Bath Filter in this chapter.
• Replace the Rinsing Head O-Ring - see Replacing the Rinsing Head O-Ring in Chapter 13,
Replacement/Adjustment Procedures.
NOTE See the complete details on the Logs screen. When the preventive maintenance is complete and
the counters are reset from the Diagnostics screen, no further reminders are logged.
• Lubricate the Pistons - see Lubrication Pos. (Syringe Assembly Piston Lubrication) in Chapter 10,
Troubleshooting.
NOTE The reminder for Lubricate the Pistons gets reset after the successful completion of the
Lubrication preventive maintenance.
8
Perform the following bleach cycle as required by the system (the system displays a message and logs
an event as a warning). Select
to perform the procedure or
to cancel. To perform the
bleach cycle, see Performing a Bleach Cycle in Chapter 12, Cleaning Procedures.
NOTE The Bleach Cycle prompt will display and log the first 10 reminders (the number of reminders is
displayed on the screen). Additional reminders will only be displayed, but not logged. The Bleach
Cycle reminder gets reset after the successful completion of a bleach cycle.
9
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Run Daily Checks. See Running Daily Checks.
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Updates to the DxH 560 Instructions for Use
Specimen Collection
10 To log out, select
.
Specimen Collection
Description of Change
A statement about predilute samples was added.
Location of Change
First CAUTION in the Specimen Collection section in Chapter 5, Sample Analysis
New/Updated Information
CAUTION
Risk of erroneous results. Running a blood sample in an incorrect analysis mode
can cause erroneous results. Run a whole-blood sample only in the whole-blood
mode. Run a predilute sample only in the predilute mode.
Loading Cassettes
Description of Change
Information about tubes was added and the procedure for loading cassettes was updated.
Location of Change
Loading Cassettes in Chapter 5, Sample Analysis
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Updates to the DxH 560 Instructions for Use
Loading Cassettes
New/Updated Information
Loading Cassettes
The cassette is the carrier for the sample tubes (patient or control) used in cassette presentation
where automatic loading, mixing, and aspiration occurs.
When loading tubes into the cassette, ensure that the correct tubes are inserted correctly (see
Figure 5.2, Type 1 Cassette for Tubes (Except for Microtainer Tubes) and Figure 5.3, Type 2 Cassette for
Microtainer Tubes) and firmly placed into the cassette before processing.
CAUTION
Risk of erroneous results. Using an incorrect cassette type for the analysis of
microtainer specimen tubes can result in partial aspiration. For cassette
presentation, specimen tubes must be processed in the correct cassette type.
Follow the information in the Hematology Tube List (see Related Documents).
Note that all tubes except for Microtainer tubes go in the cassette with the white label on top as
shown in Figure 5.2, Type 1 Cassette for Tubes (Except for Microtainer Tubes). The Microtainer tubes
go in the cassette with the pink label on top as shown in Figure 5.3, Type 2 Cassette for Microtainer Tubes.
Figure 5.2 Type 1 Cassette for Tubes (Except for Microtainer Tubes)
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Updates to the DxH 560 Instructions for Use
Loading Cassettes
Figure 5.3 Type 2 Cassette for Microtainer Tubes
3-16
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Updates to the DxH 560 Instructions for Use
Loading Cassettes
WARNING
Risk of biohazardous contamination. Using an incorrect cassette type for the
analysis of microtainer specimen tubes can result in specimen tube damage. For
cassette presentation, specimen tubes must be processed in the correct cassette
type. Follow the information in the Hematology Tube List (see Related
Documents).
WARNING
Risk of personal injury. Improperly forcing a tube into the cassette could cause it
to break. If a tube should break, use your laboratory’s safety procedure for
cleaning the broken glass.
WARNING
Risk of personal contamination. Do not mix false-bottom (short-pierce) tubes with
full-pierce tubes in a cassette where the tube bottom adjustment is set for a full
pierce. The false-bottom tube could be punctured by the force of the aspiration
probe, resulting in a spill.
1
PN C80670AA
When using a Type 1 cassette, slide each sample firmly into the cassette and click it into place.
Ensure that for the Type 2 cassette, the Microtainer tube fits properly over the peg at the bottom of the
cassette and is then pushed into position.
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3
Updates to the DxH 560 Instructions for Use
Loading Cassettes
WARNING
Risk of biohazardous contamination. Inserting specimen tubes into cassettes
upside down can result in specimen tube damage. Specimen tubes must be
inserted bottom-first into the cassettes.
2
Ensure that the bar codes are facing up within the cassette window.
NOTE In the following figure, the first three tubes are examples of incorrect bar-code label placement;
the last two tubes are examples of good bar-code label placement.
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Updates to the DxH 560 Instructions for Use
Running Sample Analysis
WARNING
Risk of operator injury. Loading additional cassettes into the input area while a
cassette is being transferred by the instrument can result in a pinched hand or
finger. Do not load additional cassettes into the input area while the instrument
is transferring a cassette from the input area to the mixer.
3
To unload from Type 1 or Type 2 cassettes, see below:
• To unload from Type 1 cassette, push firmly on the bottom of each tube. This causes the tube
to angle outward allowing the tube to be easily unloaded.
• To unload from Type 2 cassette, grip the tube at the sides to pull it forward. This causes the tube
to angle outward. Push the tube up to release from the peg, then the tube can be easily unloaded.
Running Sample Analysis
Description of Change
Information about predilute was added.
Location of Change
First two paragraphs in the Running Sample Analysis section in Chapter 5, Sample Analysis
New/Updated Information
The DxH 560 is intended for use with venous or capillary whole-blood and prediluted samples only.
The instrument has three operating modes:
• Cassette - see Running Whole-Blood Samples in Cassette Presentation
• Open-Vial (OV) - see Running Whole-Blood Samples in Open-Vial Mode
• Predilute (PD) - see Running Prediluted-Blood Samples
Whole-blood samples should be analyzed in either cassette presentation or open-vial mode.
Prediluted samples require analysis in the predilute mode (open-vial station). Uncapped samples can
only be processed in open-vial mode.
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Updates to the DxH 560 Instructions for Use
Running Whole-Blood Samples in Cassette Presentation
Running Whole-Blood Samples in Cassette Presentation
Description of Change
The term Prediluted Whole Blood was added to the section title and a graphic of a Type 2 cassette was
included.
Location of Change
Steps 2 and 4 in the Running Whole-Blood Samples in Cassette Presentation section in Chapter 5,
Sample Analysis
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Updates to the DxH 560 Instructions for Use
Running Whole-Blood Samples in Cassette Presentation
New/Updated Information
Running Whole-Blood Samples in Cassette Presentation
WARNING
Risk of biohazardous exposure. Incomplete closure of specimen tubes can result
in spills. Ensure that specimen tube caps are tightly secured before running
samples in cassette presentation.
WARNING
Risk of biohazardous exposure. Improperly maintained cassettes can result in
specimen tubes becoming dislodged and/or broken in the instrument. Inspect
cassettes periodically for loose or missing tube grips.
IMPORTANT Specimens that may contain fibrin, cell fragments, or other debris, or have been difficult to
collect such as pediatric or oncology specimens may require special handling.
CAUTION
Risk of erroneous results. The presence of fibrin strands can cause erroneous
results. You must thoroughly inspect the sample for fibrin strands or clots.
CAUTION
Risk of erroneous results. Mix the sample properly according to your laboratory
protocol and tube manufacturer before analysis. To allow for proper mixing, do
not overfill the sample tube.
CAUTION
Possible specimen leakage or clogging of the system can occur. Excessive piercing
of sample tubes may cause coring of the stopper. The number of pierces without
problems can vary among sample tube types and manufacturers. Do not pierce a
blood collection tube more than four times.
Verify the Instructions for Use in the Hematology Tube List (see Related
Documents for more information). Some tubes have more restrictive instructions
for use and limitations on the number of pierces.
CAUTION
Risk of erroneous results. All tubes should contain a minimum volume of 1 mL for
collection devices with greater than 1 mL fill volume or 3/4 the fill volume for
devices with less than 1 mL fill volume. Insufficient volume results in increased
risk of erroneous results.
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Updates to the DxH 560 Instructions for Use
Running Whole-Blood Samples in Cassette Presentation
1
Select
.
CAUTION
Risk of misidentification. Verify the Specimen ID in the worklist if the worklist
contains entries. Confirm that the Next Specimen ID is correct before the
processing specimen message is displayed.
2
Ensure your samples have been:
• Collected properly (see Anticoagulants in CHAPTER 1, System Overview.
• Stored and handled properly (see Sample Stability and Storage - Whole Blood and Sample
Stability and Storage - Prediluted Whole Blood in CHAPTER 1, System Overview.
3
Load the specimens into the cassettes. See Loading Cassettes for additional instructions.
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
open covers and doors can cause injury. When you operate the instrument, ensure
that all covers and doors are closed.
WARNING
Risk of biohazardous contamination. Inserting specimen tubes into cassettes
upside down can result in specimen tube damage. Specimen tubes must be
inserted bottom-first into the cassettes.
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
a loose or bent probe can cause injury. If the probe is loose or bent, do not run the
instrument. See Replacing the Aspiration Probe in CHAPTER 13,
Replacement/Adjustment Procedures for information on how to replace the probe
prior to analysis.
WARNING
Risk of injury and/or exposure to biohazardous material if the contents spill out of
the tube. Use caution when handling the tube.
4
3-22
Place the cassette into the input area by following the arrows on the cassette for correct placement.
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Updates to the DxH 560 Instructions for Use
Running Whole-Blood Samples in Cassette Presentation
Type 1 cassette:
Type 2 cassette:
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3
Updates to the DxH 560 Instructions for Use
Running Whole-Blood Samples in Cassette Presentation
WARNING
Risk of operator injury. Loading additional cassettes into the input area while a
cassette is being transferred by the instrument can result in a pinched hand or
finger. Do not load additional cassettes into the input area while the instrument
is transferring a cassette from the input area to the mixer.
5
Select
and the autoloader begins processing the cassette.
NOTE To stop the autoloader and cassette processing, select
. To eject the cassette, select
> Eject Cassette.
6
After the autoloader processes the samples and the cassettes, the instrument moves the
cassettes to the output area.
NOTE If a bar code is not read, an Auto SID is assigned and the specimen is added to the Unmatched
List. See Matching Specimen ID (SID) in CHAPTER 7, Worklist.
7
Review the processed samples in the Sample Analysis - Patient Results screen or the Patient
Results screen. See CHAPTER 6, Data Review for information on reviewing samples.
NOTE The Sample Analysis - Patient Results screen automatically updates and displays the completed
specimen if
is displayed. To lock the Sample Analysis - Patient Results screen and not auto-
update the completed specimens, select
8
to display
.
Transmit or print the patient results:
• To transmit, select
Data Review.
• To print, select
Review.
>
>
or see Transmitting Patient Results in CHAPTER 6,
or see Printing Patient Results in CHAPTER 6, Data
• To set up auto-transmit and/or auto-print, see Setting Up LIS and Setting Up Printer
Options in CHAPTER 9, Setup. If you have already set up auto-transmit and/or auto-print,
the data is automatically transmitted and/or printed.
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Updates to the DxH 560 Instructions for Use
Running Whole-Blood Samples in Open-Vial Mode
Running Whole-Blood Samples in Open-Vial Mode
Description of Change
Information about Specimen ID was added.
Location of Change
Second bulleted item in the Running Whole-Blood Samples in Open-Vial Mode section in Chapter 5,
Sample Analysis.
New/Updated Information
The open-vial mode on the DxH 560 offers an alternative method for processing samples with lower
volumes or samples with tube caps that cannot be pierced. The open-vial mode is also used to
analyze STAT samples.
All test orders entered in the worklist are defaulted to cassette presentation. To process open-vial
samples, the correct mode needs to be selected.
All specimens require a valid specimen ID:
• A specimen ID is obtained from a specimen bar code. See Setting Up Next Specimen in CHAPTER
9, Setup. If a bar code cannot be read or no bar code exists, the system automatically assigns an
instrument-generated auto-sequence number (AutoSID).
• A specimen ID must be one to 16 characters in length, consist of ASCII-printable characters, and
must not have two or more consecutive spaces between characters. Specimen ID containing more
than 16 characters will be rejected.
IMPORTANT Specimens that may contain fibrin, cell fragments, or other debris, or have been difficult to
collect such as pediatric or oncology specimens may require special handling.
Running Prediluted-Blood Samples
Description of Change
A new procedure about running prediluted-blood samples was added.
Location of Change
End of Chapter 5, Sample Analysis
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Updates to the DxH 560 Instructions for Use
Running Prediluted-Blood Samples
New/Updated Information
Running Prediluted-Blood Samples
The predilute panel on the DxH 560 offers an alternative sample preparation method for samples
that cannot be directly aspirated in a whole-blood mode or for times when very little blood volume
is available through collection. The predilute panel is not intended for obtaining results that exceed
the upper limit of the analytical measuring range.
The predilute panel accepts a 1:16 dilution, prepared by mixing 20 μL of whole blood with 300 μL of
diluent. The diluted sample is analyzed using the predilute mode. The instrument reports the final
results and no correction is required.
IMPORTANT Prediluted samples require analysis in the predilute mode and must be analyzed within 15
minutes after preparation.
CAUTION
Risk of erroneous results. Mix the sample properly according to your laboratory
protocol and tube manufacturer before analysis. To allow for proper mixing, do
not overfill the sample tube.
3-26
1
Ensure that the sample tube volume exceeds 300 μL to allow enough room for mixing the
blood/diluent solution.
2
Dispense the diluent as described in Diluent Dispense in this chapter.
3
Pipette 20 μL of blood, carefully wiping the removable pipette tip after the sampling, and
dispense the blood into the same tube where the diluent was dispensed.
4
After dispensing the blood sample, perform continuous aspirations/dispenses with the pipette
going back and forth to homogenize the dilution and rinse the inside of the pipette tip.
5
Select
.
PN C80670AA
Updates to the DxH 560 Instructions for Use
Running Prediluted-Blood Samples
CAUTION
Risk of misidentification. Verify the Specimen ID in the worklist if the worklist
contains entries. Confirm that the Next Specimen ID is correct before the
processing specimen message is displayed.
6
Select
7
Identify the sample using one of the following methods:
. The autoloader will complete the sample in process and stop.
• Scan the specimen tube’s bar code and select
.
or select Next.
• Select
• Use the on-screen keyboard to enter the Specimen ID and Test (CD or CBC).
• Verify that the specimen is prediluted by selecting PD.
• Select OK to confirm your selection.
NOTE A valid specimen ID must be entered to analyze a specimen. If you have set up auto-incrementing
for open-vial mode, the Specimen ID field will be automatically populated.
8
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Select
.
3-27
3
Updates to the DxH 560 Instructions for Use
Running Prediluted-Blood Samples
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
open covers and doors can cause injury. When you operate the instrument, ensure
that all covers and doors are closed.
WARNING
Risk of injury and/or biohazardous contamination. Operating the instrument with
a loose or bent probe can cause injury. If the probe is loose or bent, do not run the
instrument. See Replacing the Aspiration Probe in Chapter 13,
Replacement/Adjustment Procedures for information on how to replace the probe
prior to analysis.
WARNING
Risk of injury and/or exposure to biohazardous material if the contents spill out of
the tube. Use caution when handling the tube and removing it from the cassette.
WARNING
Risk of injury and/or biohazardous contamination. The aspiration probe is sharp.
To avoid being pierced by the aspiration probe, use caution when presenting
samples for analysis during this procedure.
CAUTION
Risk of erroneous results if in open-vial mode if the tube is removed while the
system is aspirating. Do not remove the tube until the probe retracts.
9
Open the autoloader door to expose the probe and select
. The probe is extended.
10 Fully immerse the probe into the tube and select
to analyze the sample. A message
is displayed on the bottom left of the screen indicating that the Specimen ID is being analyzed.
11 Remove the tube from the probe when the status LED turns solid red and the probe is fully
retracted.
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Updates to the DxH 560 Instructions for Use
Performing a Shutdown
WARNING
Risk of operator injury. Closing the autoloader door can result in a pinched hand
or pinched fingers. Ensure that hands and fingers are not inside the instrument
while closing the autoloader door.
12 Close the autoloader door. A message is displayed on the bottom left side of the screen
indicating that the Specimen ID is being analyzed.
13 Wait for the instrument to process the sample and display the results. The LED status turns
green.
14 Transmit or print the patient results:
• To transmit, select
Data Review.
• To print, select
Review.
>
>
or see Transmitting Patient Results in Chapter 6,
or see Printing Patient Results in Chapter 6, Data
• To set up auto-transmit and/or auto-print, see Setting Up LIS and Setting Up Printer
Options in Chapter 9, Setup. If you have already set up auto-transmit and/or auto-print, the
data is automatically transmitted and/or printed.
15 To process additional prediluted samples, follow steps 1 through 14
OR
To resume cassette processing, select
.
Performing a Shutdown
Description of Change
Clarification and additional information for performing a shutdown have been added.
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Updates to the DxH 560 Instructions for Use
Performing a Shutdown
Location of Change
Steps 3 and 6 and an addition of a step 7 in the Performing a Shutdown procedure in Chapter 8,
Shutdown
New/Updated Information
Performing a Shutdown
Beckman Coulter recommends performing a shutdown once every 24 hours. Shutdown removes
diluent and replaces it with cleaner for 30 minutes. It also checks the expiration date and volume of
the reagents. If expired or if the volume is low, the system prompts you to replace the reagent, or
to continue and record the expired reagent in the logs.
1
From the main menu, select
2
Select
3
From the Shutdown dialog box, select one of the following:
.
.
• Power Instrument Down After Shutdown- this option has the instrument perform a
shutdown followed by a power down. Additional Time in Cleaner does not apply.
• Perform Daily Checks After Shutdown- this option places the instrument in cleaner for 30
minutes plus the duration indicated in the Additional Time in Cleaner followed by Daily
Checks.
4
Use the keypad to indicate Additional Time in Cleaner (0 to 5 hours and 0 to 59 minutes) for
greater than 30-minute shutdown cycles.
5
Select
6
Select
.
to continue.
NOTE If the Bleach Cycle has not been performed, a warning message appears recommending this
preventive maintenance to be done; along with a dialog box.
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Updates to the DxH 560 Instructions for Use
Powering Down
7
From the dialog box, select one of the following:
• Perform Shutdown- this option has the instrument perform a shutdown.
• Perform Bleach followed by Shutdown- this option allows the instrument to automatically
perform a bleach cycle then shutdown.
NOTE The bottom left corner of the screen displays Shutdown and a progress bar is shown displaying
time remaining in cleaner. The power button is red for the total duration. If Additional Time in Cleaner
is selected, the progress bar will end after this time.
Powering Down
Description of Change
The Powering Down procedure has been updated.
Location of Change
Powering Down section in Chapter 8, Shutdown
New/Updated Information
Replace the current procedure with this procedure:
Powering Down
1
Press the power button for a few seconds to activate a Power Down.
2
Perform one of the following:
• If the system is not in cleaner and the bleach cycle is recommended, the system displays a dialog
box for you to select one of the following options:
— Perform Shutdown - no bleach cycle is performed. A warning reminder is displayed and the
event is logged as a warning. The Shutdown cycle is performed.
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Updates to the DxH 560 Instructions for Use
Setting Up Auto Logout
— Perform Bleach followed by Shutdown - a bleach cycle is performed followed by a shutdown
and a power down (see the IFU, Performing a Bleach Cycle section in Chapter 12, Cleaning
Procedures).
NOTE The Bleach Cycle prompt will display and log the first 10 reminders (the number of
reminders is displayed on the screen). Additional reminders will only be displayed, but not
logged. The Bleach Cycle reminder gets reset after successful completion of a bleach cycle.
• If the system is already in cleaner, the system displays a message for you to perform a power
down. Select OK to power down the system.
Setting Up Auto Logout
Description of Change
The Setting Up Auto Logout procedure has been updated.
Location of Change
Last sentence in step 2 in the Setting Up Auto Logout section in Chapter 9, Setup
New/Updated Information
Setting Up Auto Logout
This setup option requires administrator access for setting up the auto-logout time.
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1
Select
2
From the Auto Logout dialog box, use the on-screen keypad to enter a time value between 1 and
60 minutes. The default is 15 minutes.
>
>
.
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Updates to the DxH 560 Instructions for Use
Setting Up LIS
3
Select
, when prompted, to accept the information.
NOTE If the system is inactive for more than the defined time, you are automatically logged out and the
logon screen is displayed as follows:
To log in with a different Operator ID, select
.
Setting Up LIS
Description of Change
The Setting Up LIS procedure has been updated.
Location of Change
First sentence in NOTE in step 3 in the Setting Up LIS section in Chapter 9, Setup
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Updates to the DxH 560 Instructions for Use
Setting Up LIS
New/Updated Information
Setting Up LIS
If your instrument is connected to a host computer, you can transmit sample results by using this
feature.
The host receiver must comply with the ASTM Host Specification for this instrument. See the Host
Transmission Manual listed in Related Documents for more information.
1
Select
2
From the LIS Setup screen, select
3
Use the on-screen keyboard and drop-down lists to enter either Ethernet Communication or
>
.
Serial Communication settings and select
to enter the communication settings.
to accept the information.
NOTE The system will need to be rebooted at the end of this setup for the changes to apply. If you do
not enter any changes and want to return to the LIS Setup screen, select
3-34
.
4
Select Enable Host > Serial or Ethernet, and enter the Device ID using the on-screen keyboard.
5
Select Auto Transmit - Patient and select the type of sample from the options to be automatically
transmitted.
6
Select Transmit DIFF Scatterplot and/or Transmit RBC & PLT Histogram.
7
Select
, when prompted, to confirm your selection.
PN C80670AA
Updates to the DxH 560 Instructions for Use
Updating the Printer Driver
Updating the Printer Driver
Description of Change
A new section on updating the printer driver has been added.
Location of Change
Add after the Setting Up the Admin Printer section in Chapter 9, Setup
New/Updated Information
Updating the Printer Driver
IMPORTANT The printer driver icon
is available at the Administrator and Service security access
levels. However, the procedure to update the printer driver should only be performed by your Beckman
Coulter Service Representative. Contact your local Beckman Coulter Representative if your printer driver
requires an update.
>
, the system prompts the user to insert a USB
If the Administrator-level user selects
flash drive into the instrument’s USB port. DO NOT insert a USB flash drive into the port. Instead, select
Cancel to exit the screen.
Diluent Dispense
Description of Change
Information about the dilution for use on prediluted samples has been added and procedure was
updated.
Location of Change
Diluent Dispense section in Chapter 10, Troubleshooting.
New/Updated Information
Diluent Dispense
Diluent Dispense dispenses 300 μL of diluent to prepare a dilution for use on prediluted samples
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Updates to the DxH 560 Instructions for Use
Diluent Dispense
WARNING
Risk of injury and/or biohazardous contamination. To avoid being pierced by the
aspiration probe, use caution when presenting samples for analysis during this
procedure.
WARNING
Risk of operator injury. Closing the autoloader door can result in a pinched hand
or pinched fingers. Ensure that hands and fingers are not inside the instrument
while closing the autoloader door.
1
Open the autoloader door.
2
Select
3
Select Diluent Dispense.
.
WARNING
Risk of injury and/or biohazardous contamination. The aspiration probe is sharp.
To avoid being pierced by the aspiration probe, use caution when presenting a
sample for analysis during this procedure.
4
Select
5
Place a clean empty tube without anticoagulant under the aspiration probe and select
to dispense the diluent.
to confirm diluent dispense.
CAUTION
Risk of damage to the aspiration probe. Be careful not to bend the aspiration
probe when removing the tube.
3-36
6
When the dispensing is complete, remove the tube.
7
Close the autoloader door.
PN C80670AA
Updates to the DxH 560 Instructions for Use
Valve Checks (Now Check Valves)
Valve Checks (Now Check Valves)
Description of Change
Valve Checks has been changed to Check Valves.
Location of Change
Valve Checks section title and content in Chapter 10, Troubleshooting
New/Updated Information
Check Valves
Check Valves allow access to the valve test display.
1
Select
2
From the Diagnostics - Check Valves screen, select a valve number to turn it ON or OFF.
> Check Valves.
You can select ALL VLs ON to turn ON or OFF all valves, EV CHASER to turn the valves ON or OFF
in sequence, or SHEAR VALVE to rotate the shear valve.
When, Why, and How to Perform Each Cleaning Procedure
Description of Change
A new frequency for performing a bleach cycle has been added.
Location of Change
Table 12.1 Matrix of Frequency for Cleaning Procedures in Chapter 12, Cleaning Procedures
New/Updated Information
Table 12.1 Matrix of Frequency for Cleaning Procedures
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Updates to the DxH 560 Instructions for Use
Cleaning the WBC Bath Filter
Procedure
Purpose
Tools/Supplies
Frequency
Performing a Bleach
Cycle
To remove clogs
• High-quality,
fragrance-free, gelfree bleach (3.6%
solution of sodium
hypochlorite available chlorine)
• Deionized water
• Container for bleachdeionized water
solution
• Container for
deionized water
Every 1,000 cycles or
every 2 weeks,
whichever comes first; or
as needed for
troubleshooting
purposes
Cleaning the WBC Bath Filter
Description of Change
A new step for performing the procedure has been added.
Location of Change
Step 1 in Cleaning the WBC Bath Filter in Chapter 12, Cleaning Procedures.
New/Updated Information
Step 1 now includes selecting the Fluidics icon in order to access the Drain Baths function.
3-38
1
Select
> Fluidics > Drain Baths to drain the baths, vacuum, and waste syringes. When
the power button turns green, go to the next step.
2
Continue steps 2 to 18 as per procedure in IFU.
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Updates to the DxH 560 Instructions for Use
Access Levels
Access Levels
Description of Change
Clarification about access levels for the Calibration START feature has been added to Table A.1
Security Access Levels. A new Reset Counters feature has also been added.
Location of Change
Table A.1 Security Access Levels
New/Updated Information
Feature
Operator
Administrator
Calibration
Y
Y
Start
N
Y
Display
Y
Y
Cal Factors
N
Y
Finish
N
Y
Setup
N
Y
Edit
N
Y
Diagnostics
Y
Y
Reset Counters
Y
Y
Reports
Description of Change
The title for Figure A.3 has been changed.
Location of Change
Figure A.3 in the Reports section in Appendix A, Access Levels and Reports.
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Updates to the DxH 560 Instructions for Use
Reports
New/Updated Information
Figure A.3 Patient Results - CD, Prediluted Blood - Format 1.
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Updates to the DxH 560 Instructions for Use
Training Checklist
3
Training Checklist
Description of Change
Information about prediluted blood samples has been added.
Location of Change
In the Patient Samples topic under the last bulleted item in the Description column for Chapter 5,
Sample Analysis in Table C.1, Training Checklist.
New/Updated Information
Table C.1, Training Checklist
Initials/
Date
Completed
Topic
Description
Patient
Samples
CHAPTER 2, Operation Principles
• Understand abnormal diff scatter plot and histograms from normal results. See CHAPTER 2,
Operation Principles.
• Read Parameter Measurement, Derivation, and Calculation.
CHAPTER 1, System Overview
• Review interfering substances. See Limitations.
CHAPTER 5, Sample Analysis
• See Identifying Patient Samples.
• Prepare and process whole-blood patient samples in cassettes. See Running Whole-Blood
Samples in Cassette Presentation.
• Prepare and process whole-blood patient samples in open-vial mode. See Running Whole-Blood
Samples in Open-Vial Mode.
• Prepare and process prediluted blood samples. See Running Prediluted-Blood Samples.
CHAPTER 6, Data Review
• Review patient samples and successfully search, delete, and print patient results. See
Reviewing Patient Results, Searching for Patient Results, Deleting Patient Results, and Printing
Patient Results.
• Recognize possible flags, codes, and messages. See Flags, Codes, and Messages Displayed.
CHAPTER 7, Worklist
• Create a worklist. See Setting Up a Test Order.
• Successfully match an auto-sequenced SID (Auto-SIDxxxxx) with a current worklist entry, if
applicable. See Matching Specimen ID (SID).
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Updates to the DxH 560 Instructions for Use
Abbreviations and Acronyms
Abbreviations and Acronyms
Description of Change
Prediluted has been added.
Location of Change
Under OV in Abbreviations and Acronyms
New/Updated Information
PD - prediluted
Glossary
Description of Change
A definition for predilute has been added.
Location of Change
Glossary
New/Updated Information
Predilute - Dilution of a sample prior to analysis on the analyzer
3-42
PN C80670AA
Related Documents
Your documentation can be found on our
website at www.beckmancoulter.com/techdocs.
Instructions for Use
Outside the U.S.A.: DxH 500 (PN B95837);
DxH 520 (PN B85528); DxH 560 (PN C31608)
U.S.A.: DxH 500 (PN C42118);
DxH 520 (PN C41838); DxH 560 (PN C48648)
•
System Overview
•
Operation Principles
•
Daily Checks
•
Quality Control
•
Sample Analysis
•
Data Review
•
Worklist
•
Shutdown
•
Setup
•
Troubleshooting
•
Quality Assurance
•
Cleaning Procedures
•
Replacement/Adjustment Procedures
•
Appendices
•
Abbreviations and Acronyms
•
Glossary
•
References
•
Index
•
Warranty
Host Transmission
PN B38989
Hematology Tube List (DxH 520 and DxH 560)
PN C12794
Symbols Glossary
PN C29230
China RoHS Table of Hazardous Substance’s Name
and Concentration
www.beckmancoulter.com
PN C71581
Installation, Operation, and Performance
Qualification
PN B75977
© 2015-2022 Beckman Coulter, Inc.
All Rights Reserved