RADIOMETER ABL800 FLEX User manual

ABL800 FLEX operator’s manual

ABL800 FLEX
operator’s
manual

Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, PICO and CLINITUBES are
trademarks of Radiometer Medical ApS.
© 2011 Radiometer Medical ApS. All rights reserved. 995-950. 201104A.
Note to users of the ABL800 FLEX analyzers
This note to users gathers changes from previous note to users in one document and
outlines some new changes to the operator’s manual of your ABL800 FLEX analyzer
(from software version 6.10).
Please remove the existing note to users from the binder of your manual and place this note
to users in the binder instead.
Changes/Description
Limitations of use and known interfering substances:
CAUTION - Known interfering substances
Substance Interference
ClO4–(drugs) For ClO4– ,interference on cCa2+ (1.25 mmol/L
level), cCl(110 mmol/L level), and cK+ (4
mmol/L level) has been detected:
cCa2+ (1.25 mmol/L level): 0.27*
cCl(110 mmol/L level): 4-30
cK+ (4 mmol/L level): 0.3.
Interference –
new interference
results for ClO4–
* Depending on the pH level
USB connector Instead of the CD-ROM drive, a USB connector may be available.
The USB connector can be used for storing data on an USB flash
drive (memory stick) or for connecting USB devices. Can also be
used for installation of software.
Introduction
Instructions to
user
Brief overview
of the change
USB connector or
CD-ROM drive

Measured
parameters New table for pleural liquid:
Parameter Unit Measuring
Range Test range
pH pH scale 6.300-8.000 7.0-7.5*
* If the measured values obtained lie outside the test range,
Radiometer advises you to repeat the measurement by means of
another method.
Indoor use statement added according to CSA regulations:Environmental
requirements Location Indoor use only
Environmental
ratings Pollution degree 2 statement added according to CSA regulations:
Installation category II.
Pollution degree 2.
Clot detection A new feature is included in software version 6.06 of the following
products:
 ABL7xx Series (XPE) analyzers
 ABL800 FLEX analyzers
 ABL800 BASIC analyzer.
The new feature enables the analyzer to detect clots caught in the
measurement chamber under the pH electrode. This document
describes it.
When to activate the clot-detection feature
It is especially beneficial to activate the clot detection feature in
analyzers frequently used to analyze samples known to be prone to
clotting, for example, samples drawn from umbilical cords. Once
activated clot detection is active during all sample measurements.
NOTICE: It is important to note that activating the feature will
delay measurement results by approximately one minute, even
though it only increases the measurement cycle time by five
seconds. It also increases consumption of Rinse solution, but this is
minimal.

To activate the clot-detection feature
Contact a Radiometer representative and request that clot detection
be enabled via the service program.
Clot-detection process
During calibration the measuring chamber is rinsed and the pH of
the Rinse solution is measured. The value is stored in the analyzer.
During a sample measurement the measuring chamber is also rinsed
and the pH of the rinse solution is measured and compared with the
pH value stored during the last calibration. If the difference between
these values (the pH drift) exceeds a pre-determined maximum
value, it could indicate the presence of a clot beneath the pH
electrode.
When enabled, the clot-detection feature can generate three new
messages that are listed below.
Analyzer messages
NOTICE: Operator actions are listed in order of priority. Perform
the first action in the list and the actions indicated in the "Removal
condition(s) list. If the message persists, perform the next listed
action and the actions indicated in the "Removal condition(s) list,
and so on.
No. Message Interpretation Operator action(s)
Clot suspected
beneath pH
electrode*
The difference
between the pH of
the rinse solution,
measured during the
sample measurement,
and that stored after
the last calibration
exceeds the
maximum allowable
drift.
This indicates the
presence of a clot in
the measuring
chamber beneath the
pH electrode.
Remove the pH electrode and
check the measuring chamber for
clots: clean the measuring
chamber with a cotton stick
moistened with distilled water.
Make sure no cotton fibers are
left in the measuring chamber
Clean pH electrode
Remembrane Ref electrode
Replace pH electrode
Perform a 1- or 2-point calibration
Removal condition(s):
 Acknowledge execution of the
"Clot removal procedure"
 Successful 1- or 2-point
calibration
1025
* NOTICE: This is a system message.

1026 Clot (pH)
detection not
possible
The pH of the rinse
solution - stored
during the latest
calibration - was
invalidated when
either the Rinse
solution was
replaced, or when
maintenance was
performed on an
electrode.
A new pH value
needs to be
established by
performing a
calibration.
 Perform a 1- or 2-point
calibration.
Removal condition(s):
 Successful 1- or 2-point
calibration.
1027 Clot suspected
beneath pH
electrode
The difference
between the pH of
the rinse solution,
measured during the
sample measurement,
and that stored after
the last calibration
exceeds the
maximum allowable
drift.
This indicates the
presence of a clot in
the measuring
chamber beneath the
pH electrode.
 Remove the pH electrode and
check the measuring chamber for
clots: clean the measuring
chamber with a cotton stick
moistened with distilled water.
Make sure no cotton fibers are
left in the measuring chamber
 Clean pH electrode
 Remembrane Ref electrode
 Replace pH electrode
Perform a 1- or 2-point calibration
Removal condition(s):
 Acknowledge execution of the
"Clot removal procedure"
 Successful 1- or 2-point
calibration
Step Action
1. Press Analyzer status > Electrodes and others.
2. Press Replace.
Acknowledging
execution of a
"Clot-removal
procedure"
3. Press Clots removed.
Data in this document will be added to the manual next time it is updated.
Radiometer Medical ApS
Åkandevej 21
2700 Brønshøj
Denmark
www.radiometer.com
Technical
documentation

Table of contents
1. Introduction
2. What is what
3. Installation and setup
4. Sample measurements
5. Quality control
6. Calibration
7. Replacements
8. Disk functions
9. Data management
10. Analyzer shutdown
11. Troubleshooting
12. Sampling
13. Specifications
14. Ordering information
15. Radiometer settings
Index - Date of issue
ABL800 FLEX
Operator’s manual

System performance
The procedures described in this manual must be observed in order to ensure proper system
performance, and to avoid hazards.
Radiometer cannot provide or verify system performance characteristics if the system is not installed,
used and maintained in accordance with Radiometer procedures or if accessories not meeting the
specifications provided by Radiometer are used.
Radiometer warrants that the data media on which the software included in the system is furnished is
free from defects in material and workmanship under normal use for three (3) months from the date of
delivery as evidenced by a copy of invoice or receipt.
Third-party software and trademarks
The ABL800 FLEX analyzers comprise the MicrosoftWindowsXP Embedded, VxWorksand
SybaseSQL Anywheresoftware.
By using the system, you accept the terms of the Software License Agreement(s) of the provider(s) of
the above software as shown in the End User License Agreement(s) in the analyzer start up picture and
to the terms of the MicrosoftWindowsXP Embedded End-User Agreement included in this manual. If
you cannot accept the terms of the Software License Agreement(s), you should not use the system, but
immediately contact your provider for a return of the system and a refund of the purchase price.
Microsoft® and Windows® are trademarks of Microsoft Corporation.
VxWorksis a registered trademark of WindRiver Systems Incorporated.
SybaseSQL Anywhereis a registered trademark of Sybase Incorporated.
Warranties and disclaimer
Radiometer makes no warranties, express or implied, other than expressly stated.
Any warranties expressly stated in this document are conditional upon the system being installed, used
and maintained in accordance with Radiometer procedures, including that only accessories meeting the
specifications provided by Radiometer are used.
Radiometer disclaims any liability for system performance if the system is not installed, used and
maintained in accordance with Radiometer procedures or if accessories not meeting the specifications
provided by Radiometer are used.
Further, Radiometer disclaims any liability for loss of data and direct, consequential or other damages,
including loss of profit or loss of business, whether such claim for damages is based upon contract,
negligence or tort (including strict liability), and even if Radiometer has knowledge of the possibility of the
potential damage or loss.
Confidentiality
The contents of this document shall not be reproduced or communicated to any third party without the
prior written consent of Radiometer.
Changes
This document is subject to change without notice and you are urged to contact Radiometer to verify
whether the document has been changed.
While every effort is made to ensure the correctness of the information provided in this document as
changed from time to time, Radiometer disclaims any liability for errors and omissions.
Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, PICO and CLINITUBES are trademarks of
Radiometer Medical ApS.
© 2011 Radiometer Medical ApS. All rights reserved.

TEnd-User License Agreement for the ABL800 FLEX Analyzers
You have acquired a device ("DEVICE") THAT INCLUDES SOFTWARE LICENSED BY Radiometer
Medical ApS from Microsoft Licensing Inc. or its affiliates ("MS"). Those installed software products of
MS origin, as well as associated media, printed materials and "online" or electronic documentation
("SOFTWARE") are protected by international intellectual property laws and treaties. The SOFTWARE
is licensed, not sold. All rights reserved.
IF YOU DO NOT AGREE TO THIS END-USER LICENSE AGREEMENT ("EULA"), DO NOT USE
THE DEVICE OR COPY THE SOFTWARE . INSTEAD, PROMPTLY CONTACT THE SUPPLIER OF
THE INSTRUMENT FOR INSTRUCTIONS ON RETURN OF THE UNUSED DEVICE(S) FOR A
REFUND. ANY USE OF THE SOFTWARE, INCLUDING BUT NOT LIMITED TO USE ON THE
DEVICE WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA (OR RATIFICATION OF ANY
PREVIOUS CONSENT).
GRANT ON SOFTWARE LICENSE. This EULA grants you the following license:
• You may use the SOFTWARE only on the DEVICE.
• NOT FAULT TOLERANT. THE SOFTWARE IS NOT FAULT TOLERANT. RADIOMETER
MEDICAL ApS HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE
DEVICE, AND MS HAS RELIED UPON RADIOMETER MEDICAL ApS TO CONDUCT
SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR SUCH
USE.
• NO WARRANTIES FOR THE SOFTWARE. THE SOFTWARE is provided "AS IS" and with all
faults. THE ENTIRE RISK AS TO SATISFACTORY QUALITY, PERFORMANCE, ACCURACY,
AND EFFORT (INCLUDING LACK OF NEGLIGENCE) IS WITH YOU. ALSO, THERE IS NO
WARRANTY AGAINST INTERFERENCE WITH YOUR ENJOYMENT OF THE SOFTWARE OR
AGAINST INFRINGEMENT. IF YOU HAVE RECEIVED ANY WARRANTIES REGARDING THE
DEVICE OR THE SOFTWARE, THOSE WARRANTIES DO NOT ORGINATE FROM, AND ARE
NOT BINDING ON, MS.
• Note on Java Support. The SOFTWARE may contain support for programs written in Java. Java
technology is not fault tolerant and is not designed, manufactured or intended for use or resale as
online control equipment in hazardous environments requiring fail-safe performance, such as in
the operation of nuclear facilities, aircraft, navigation or communication systems, air traffic control,
direct life support machines or weapons systems, in which the failure of Java could lead directly to
death, personal injury, or severe physical or enviromental damage. Sun Microsystems, Inc. has
contractually obligated MS to make this disclaimer.
• No Liability for Certain Damages. EXCEPT AS PROHIBITED BY LAW, MS SHALL HAVE NO
LIABILITY FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES
ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE
SOFTWARE. THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF ITS
ESSENTIAL PURPOSE. IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN
EXCESS OF US. TWO HUNDRED FIFTY DOLLARS (US$250.00).
• Limitations on Reverse Engineering, Decompilation and Disassembly. You may not reverse
engineering, decompile, or disassemble the SOFTWARE, except and only to the extent that such
activity is expressly permitted by applicable law notwithstanding this limitation.
• SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS. You may permanently
transfer rights under this EULA only as a part of a permanent sale or transfer of the DEVICE, and
only if the recipient agrees to this EULA. If the SOFTWARE is an upgrade, any transfer must also
include all prior versions of the SOFTWARE.
• EXPORT RESTRICTIONS. You acknowledge that SOFTWARE is of US-origin. You agree to
comply with all applicable international and national laws that apply to the SOFTWARE, including
the US Export Administration Regulations, as well as end-user, end-use and country destination
restrictions issued by US and other governments. For additional information on exporting the
SOFTWARE, see
http://www.microsoft.com/exporting/.

Contents
This manual contains the following topics.
1. Introduction...................................................................................................... 1-1
Overview........................................................................................................... 1-1
Names and intended use.................................................................................... 1-2
Limitations of use and known interfering substances....................................... 1-4
Warning/Caution and Notices........................................................................... 1-7
Symbols overview............................................................................................. 1-8
2. What is what ..................................................................................................... 2-1
Overview........................................................................................................... 2-1
Analyzer - front................................................................................................. 2-2
Analyzer - rear .................................................................................................. 2-4
Measuring section............................................................................................. 2-5
Inlet module...................................................................................................... 2-7
FLEXQ module................................................................................................. 2-8
Thermal printer ............................................................................................... 2-10
Communication ports...................................................................................... 2-11
Barcode reader................................................................................................ 2-13
AutoCheck module ......................................................................................... 2-14
Screen elements .............................................................................................. 2-15
Menu structure................................................................................................ 2-24
Analyzer status................................................................................................ 2-28
Online aid facilities......................................................................................... 2-36
Sample counter................................................................................................ 2-39
3. Installation and setup....................................................................................... 3-1
Overview........................................................................................................... 3-1
Installation ........................................................................................................ 3-2
Setup menu structure......................................................................................... 3-3
Analyzer security.............................................................................................. 3-6
Analysis setup................................................................................................. 3-13
Patient reports ................................................................................................. 3-26
Calibration setup............................................................................................. 3-32
Quality control setup....................................................................................... 3-35
Replacement setup .......................................................................................... 3-48

Contents ABL800 FLEX Operator's Manual
Parameters and input setup ............................................................................. 3-55
Analyzer settings............................................................................................. 3-62
Communications............................................................................................. 3-68
Printers............................................................................................................ 3-77
Disk Functions setup....................................................................................... 3-80
Corrective actions ........................................................................................... 3-83
Miscellaneous setup........................................................................................ 3-86
4. Sample measurements...................................................................................... 4-1
Overview........................................................................................................... 4-1
General information.......................................................................................... 4-2
Immediately before analysis ............................................................................. 4-9
Measurements with FLEXQ ........................................................................... 4-10
Introducing a blood sample............................................................................. 4-12
Introducing a pleura sample............................................................................ 4-15
Introducing an expired air sample................................................................... 4-16
Patient identification....................................................................................... 4-17
Patient result ................................................................................................... 4-21
Calculation of FShunt and ctO2(a - _
V) ........................................................... 4-25
Patient result messages.................................................................................... 4-26
5. Quality control.................................................................................................. 5-1
Overview........................................................................................................... 5-1
General information.......................................................................................... 5-2
Preparing a control solution.............................................................................. 5-4
Manual quality control measurement................................................................ 5-6
AutoCheck measurement.................................................................................. 5-7
Quality control identification............................................................................ 5-8
Quality control result ...................................................................................... 5-10
Quality control result messages ...................................................................... 5-15
6. Calibration........................................................................................................ 6-1
Overview........................................................................................................... 6-1
General information.......................................................................................... 6-2
Unscheduled calibrations.................................................................................. 6-4
Interrupted, pending or expired calibrations..................................................... 6-5
tHb calibration .................................................................................................. 6-6
Calibration result............................................................................................... 6-8
Calibration result messages............................................................................. 6-10

ABL800 FLEX Operator's Manual Contents
7. Replacements .................................................................................................... 7-1
Overview........................................................................................................... 7-1
General information.......................................................................................... 7-2
Replacing membranes or electrodes.................................................................. 7-6
Replacing pump tubes....................................................................................... 7-9
Replacing inlet gasket unit and inlet probe..................................................... 7-12
Replacing waste container, fan filter, printer paper........................................ 7-14
Replacing solutions and gases ........................................................................ 7-16
Refilling the AutoCheck carousel................................................................... 7-19
Automatic auxiliary programs ........................................................................ 7-20
Decontamination and Protein Removal programs .......................................... 7-21
Cleaning the analyzer...................................................................................... 7-23
List of references............................................................................................. 7-25
8. Disk Functions .................................................................................................. 8-1
Overview........................................................................................................... 8-1
General information.......................................................................................... 8-2
Creating a WDC report..................................................................................... 8-4
Backing up all data............................................................................................ 8-6
Restoring all data .............................................................................................. 8-8
Exporting data logs........................................................................................... 8-9
Importing/exporting archives.......................................................................... 8-11
Saving setup.................................................................................................... 8-13
Loading/restoring setup .................................................................................. 8-14
9. Data management............................................................................................. 9-1
Overview........................................................................................................... 9-1
General information.......................................................................................... 9-2
Patient Results Log........................................................................................... 9-4
Patient Profiles Log........................................................................................... 9-7
Quality Control Log........................................................................................ 9-11
Calibration Log............................................................................................... 9-17
Activity Log.................................................................................................... 9-20
Replacement Log ............................................................................................ 9-23
Archived data logs .......................................................................................... 9-24
RADIANCE browser (optional) ..................................................................... 9-26
10.Analyzer shutdown......................................................................................... 10-1
Overview......................................................................................................... 10-1
General information........................................................................................ 10-2

Contents ABL800 FLEX Operator's Manual
Standby mode ................................................................................................. 10-3
Full waste container........................................................................................ 10-5
Temporary Shutdown...................................................................................... 10-6
Long Term Shutdown ..................................................................................... 10-8
11.Troubleshooting.............................................................................................. 11-1
Overview......................................................................................................... 11-1
General information........................................................................................ 11-2
Forced Hold causes......................................................................................... 11-5
Analyzer messages.......................................................................................... 11-7
Fluid transport troubleshooting procedure.................................................... 11-74
Inlet probe troubleshooting procedure.......................................................... 11-75
Inlet troubleshooting procedure.................................................................... 11-76
Leak troubleshooting procedure ................................................................... 11-77
Electrode troubleshooting procedures........................................................... 11-78
Pump troubleshooting procedure.................................................................. 11-80
Fluid transport system description................................................................ 11-81
12.Sampling.......................................................................................................... 12-1
Overview......................................................................................................... 12-1
Causes of errors in preanalytical phase........................................................... 12-2
Preparation prior to arterial/venous sampling................................................. 12-5
Preparation prior to capillary sampling........................................................... 12-7
Sampling devices ............................................................................................ 12-8
Storage and preparation prior to analysis........................................................ 12-9
Sampling procedures..................................................................................... 12-12
References..................................................................................................... 12-15
13.Specifications .................................................................................................. 13-1
Overview......................................................................................................... 13-1
Measured parameters ...................................................................................... 13-2
Input parameters.............................................................................................. 13-5
Derived parameters......................................................................................... 13-6
Sample handling.............................................................................................. 13-8
Calibration and maintenance programs......................................................... 13-11
Analyzer requirements.................................................................................. 13-13
Analyzer specifications................................................................................. 13-14
Approvals and patents................................................................................... 13-16

ABL800 FLEX Operator's Manual Contents
14.Ordering information..................................................................................... 14-1
Overview......................................................................................................... 14-1
Analyzer accessories....................................................................................... 14-2
Quality control................................................................................................ 14-5
Sampling devices ............................................................................................ 14-7
15.Radiometer settings........................................................................................ 15-1
Overview......................................................................................................... 15-1
Radiometer default settings............................................................................. 15-2
Contents of setup settings ............................................................................. 15-15
Calibration verification................................................................................. 15-18
Interfacing facilities...................................................................................... 15-20
Index
Date of issue

Contents ABL800 FLEX Operator's Manual

1. Introduction
Overview
Introduction The chapter briefly describes the intended use of the analyzer, lists all measured
parameters and the substances known to interfere with the measurements, and
explains the different notices that appear in the manual.
Throughout this manual, "ABL800 FLEX analyzer" is used for all ABL8xx FLEX
analyzers, i.e.: ABL837/835/830/827/825/820/817/815/810/805 and ABL810 BG
only.
The abbreviation "ABL8x7 FLEX analyzer" is used for the ABL837/27/17 FLEX
analyzers throughout this manual.
Contents This chapter contains the following topics.
Names and intended use................................................................................... 1-2
Limitations of use and known interfering substances...................................... 1-4
Warning/Caution and Notices.......................................................................... 1-7
Symbols overview........................................................................................... 1-8

1. Introduction ABL800 FLEX Operator's Manual
Names and intended use
Names Proprietary name: ABL800 FLEX blood gas, oximetry, electrolyte and
metabolite analyzer.
Common name: Blood gas, oximetry, electrolyte and metabolite measuring
system.
Intended use The ABL800 FLEX analyzers are intended for:
• In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2,
cK+, cNa+, cCa2+, cCl–, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters
(ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and
FHbF)
• in vitro testing of samples of expired air for the parameters pO2and pCO2
• in vitro testing of pleura samples for the pH parameter.
The following parameters can be measured on blood:
Parameter group Parameters
pH (acidity)
pCO2(carbon dioxide tension)
pH/blood gas:
pO2(oxygen tension)
ctHb (total hemoglobin concentration)
sO2(oxygen saturation)
FO2Hb (fraction of oxyhemoglobin in total hemoglobin)
FCOHb (fraction of carboxyhemoglobin in total hemoglobin)
FHHb (fraction of deoxyhemoglobin in total hemoglobin)
FMetHb (fraction of methemoglobin in total hemoglobin)
Oximetry:
FHbF (fraction of fetal hemoglobin)
cK+(potassium ion concentration)
cNa+(sodium ion concentration)
cCa2+ (calcium ion concentration)
Electrolytes:
cCl– (chloride ion concentration)
cGlu (D-glucose concentration)
cLac (L(+)-lactate concentration)
ctBil (concentration of total bilirubin, measurement in plasma
is possible, see Limitations of use later in this chapter)
Metabolites:
cCrea (concentration of creatinine, measurement on plasma
and serum possible, see Limitations of use later in this chapter)
Continued on next page
1-2