RADIOMETER ABL800 FLEX Operator's Manual
ABL800 FLEX operator’s manual
ABL800 FLEX
operator’s
manual
Introduction
Instructions to
user
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.
Brief overview
of the change
Interference –
new interference
results for ClO
4
USB connector
Changes/Description
Limitations of use and known interfering substances:
–
CAUTION - Known interfering substances
Substance Interference
ClO
–
(drugs)
4
For ClO
level), cCl
mmol/L level)
cCa
cCl
cK
– ,
interference on cCa2+ (1.25 mmol/L
4
(110 mmol/L level), and cK+ (4
has been detected:
2+
(1.25 mmol/L level): 0.27*
(110 mmol/L level): 4-30
+
(4 mmol/L level): 0.3.
* Depending on the pH level
Instead of the CD-ROM drive, a USB connector may be available.
USB connector or
CD-ROM drive
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.
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.
Measured
New table for pleural liquid:
parameters
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
Environmental
ratings
Clot detection A new feature is included in software version 6.06 of the following
Location Indoor use only
Pollution degree 2 statement added according to CSA regulations:
Installation category II.
Pollution degree 2.
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)
1025
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
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
maximum al l owable
drift.
This indicates the
presence of a clot in
the measuring
chamber beneath the
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
* 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
Acknowledging
execution of a
"Clot-removal
procedure"
The difference
between the pH of
the rinse solution,
measured during the
sample measurement,
and that stored after
the last calibration
exceeds the
maximum al l owable
drift.
This indicates the
presence of a clot in
the measuring
chamber beneath the
pH electrode.
Step Action
Press Analyzer status > Electrodes and others.
1.
Press Replace.
2.
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
Technical
documentation
Press Clots removed.
3.
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
Table of contents
ABL800 FLEX
Operator’s manual
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
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 WindowsXP 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 WindowsXP 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, incl uding 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 -
_
) ........................................................... 4-25
V
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
Overview
Introduction
Contents
1. 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.
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
Intended use
Proprietary name: ABL800 FLEX blood gas, oximetry, electrolyte and
metabolite analyzer.
Common name: Blood gas, oximetry, electrolyte and metabolite measuring
system.
The ABL800 FLEX analyzers are intended for:
• In Vitro testing of samples of whole blood for the parameters pH, pO
+
cK
, cNa+, cCa2+, cCl–, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters
(ctHb, sO
2
, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and
FHbF)
• in vitro testing of samples of expired air for the parameters pO
and pCO2
2
• in vitro testing of pleura samples for the pH parameter.
The following parameters can be measured on blood:
Parameter group Parameters
pH/blood gas:
Oximetry:
pH (acidity)
pCO2 (carbon dioxide tension)
(oxygen tension)
pO
2
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)
FHbF (fraction of fetal hemoglobin)
, pCO2,
2
1-2
Electrolytes:
Metabolites:
cK+ (potassium ion concentration)
cNa+ (sodium ion concentration)
2+
cCa
(calcium ion concentration)
–
(chloride ion concentration)
cCl
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)
cCrea (concentration of creatinine, measurement on plasma
and serum possible, see Limitations of use later in this chapter)
Continued on next page
ABL800 FLEX Operator's Manual 1. Introduction
Names and intended use, Continued
Intended use
(continued)
The following parameters can be measured on pleura samples:
Parameter group Parameters
Measured value pH (acidity)
The following parameters can be measured on expired air samples:
Parameter group Parameters
Measured values pCO2 (carbon dioxide tension)
pO
(oxygen tension)
2
Derived parameters are listed in chapter 13: Specifications and described in detail
in the Reference Manual, chapter 6.
Requirement to
the operator
Measurements
on animal blood
FLEXMODE
Measurements
on pleural fluids
Other fluids
mode
FLEXQ module
NOTICE:
The analyzer should be used by personnel who have received special education and
training with regard to procedures utilizing in vitro diagnostic medical devices.
Animal blood has not been tested on the ABL800 FLEX analyzer. Some
components in animal blood differ from those in human blood, and variations in
the composition of blood from different animal species may also exist.
This mode allows you to analyze a blood sample of 35 μL and higher – up to the
maximum volume accepted by your analyzer. Depending on the available sample
volume, the FLEXMODE provides the highest number of parameters: from all
available to as many as reliably possible.
This mode is not available in the ABL8x7 FLEX analyzers.
Pleura pH can be measured on pleural fluids. Corrections are present in the device.
All parameters available on your ABL800 FLEX analyzers can be measured on
fluids other than heparinized human whole blood
NOTICE: Before using this mode you must establish "user-defined corrections"
for each parameter used, on the fluid in question. The corrections assume a linear
correlation between the measured value and the reference instrument. The data
used for establishing "user-defined corrections" have to cover the desired
measuring range. If no user-defined corrections are entered, you will measure in
this mode as if on heparinized human whole blood.
The FLEXQ module can accommodate up to three samplers simultaneously. It
reads a sampler's barcode, mixes the sample and transports the sampler to the inlet
for aspiration and analysis without any further assistance from the operator.
Results can be delivered via FLEXLINK (for information refer to the RADIANCE
Installation and Setup Manual).
The model ABL810 can also be ordered without oximetry parameters: as ABL810
BG only.
1-3
1. Introduction ABL800 FLEX Operator's Manual
r
Limitations of use and known interfering substances
Limitations of
use
The following limitations should be taken into consideration:
The ABL800 FLEX analyzers are designed for measurements of adult and fetal
hemoglobin with normal spectrum characteristics. Some spectra deviate from the
normal characteristics, e.g. for certain hemoglobinopathies and the ABL800 FLEX
analyzers do not compensate for this.
CAUTION - Fulfillment of user-specific analytical needs
The user should review the analyzer performance data to assure that the
performance fulfills the user-specific analytical needs.
WARNING – Clinical decisions
The validity of the test results from this instrument must be carefully
examined by a clinician and related to the patient’s clinical condition,
before any clinical decisions are taken on the basis of the test results.
CAUTION Known
interfering
substances
CAUTION - Risk of erroneous results
Always meticulously follow the sampling procedures described in chapter
12: Sampling. Failure to follow these procedures may introduce clots or air
bubbles in the sample and yield erroneous results.
NOTICE: Bilirubin measurements on plasma and creatinine measurements on
plasma and serum need to be measured in Other fluids mode, as the other modes
are intended for measurement on human whole blood only. Corrections for
Creatinine can be found in the Reference Manual.
FHbF measurement:
The uncertainty in FHbF measurements exceeds the level required to measure
normal HbF levels in the adult range (FHbF reference range is 0-1 %).
The following substances are known to affect or interfere with measurements on
the ABL800 FLEX analyzers.
Substance Interference
Halothane (anesthetic) May give unreliable pO2 results.
Lipid therapy (treatment) In OXI measurements.
After measurement on blood from a patient who
has received lipid therapy it may be necessary
to clean the analyzer using the Cleaning
program.
Methylene Blue, HiCN
In OXI measurements.
(medication)
Anions: B
−
−S2−
,I , and Cl
−
Erroneously high
O
4
cCl
-
results.
(drugs)
Continued on next page
1-4
ABL800 FLEX Operator's Manual 1. Introduction
Limitations of use and known interfering substances,
Continued
CAUTION Known
interfering
substances
(continued)
Anticoagulants (sampling) Anticoagulants that contain sodium salts will
Thiocyanic acid (degradation
product from treatment with
nitroprussid. Also produced in
thiosulphate treatment of cyanide
poisoning)
Substance Interference
+
cNa
give erroneously high
results. Sodium
fluoride with or without EDTA and oxalate
(di Na) influence
gives erroneously high
cGlu and cLac results. Tri sodium citrate
influences
cGlu results. Sodium fluoride
+
cNa
, cK+ and cGlu results.
+
cNa
and low cCa2+,
Thus Radiometer recommends the exclusive use
of heparin as anticoagulant. Solutions containing
organic preservatives may damage the ionselective membranes of the
+
cK
and cGlu
electrodes when introduced into the analyzer.
Do not use EDTA, as it leads to erroneous pH,
pCO
, cNa+, cK+ and cCa2+ results. Use of
2
EDTA will also affect subsequent measurements
on the Ca electrode and it will reduce the
lifetime of this electrode.
Erroneously high
cGlu and cLac measurements.
Glycolic acid (ethyleneglycol
degradation product)
Insufficiently stabilized blood.
Caustic fluids (e.g. strong acids
or bases, detergents, etc.).
Fluids that precipitate.
Fluids that affect the sensor
enzymes.
Fluids that form complexes with
the analyzer solutions (calcium).
High viscosity fluids.
Hydrophobic fluids.
Reactive fluids.
Erroneously high cLac measurements.
Other fluids mode allows you to measure on
fluids other than heparinized human blood.
Be aware that some substances, such as listed in
the left column, measured in the Other fluids
mode may damage the instrument or the
electrodes. This can affect the subsequent
measurement on human blood or quality control
solutions.
Continued on next page
1-5
1. Introduction ABL800 FLEX Operator's Manual
Limitations of use and known interfering substances,
Continued
CAUTION Known
interfering
substances
(continued)
Carboxymethyl cellulose (CMC)
Substance Interference
Some auto-venting arterial blood samplers
contain carboxymethyl cellulose (CMC) in
the porous vent. CMC can dissolve into the
sample and give erroneously low
cCa
2+
results. Therefore we recommend
Radiometer accessories together with our
analyzers, e.g. the
safePICO arterial blood
sampler which is specifically designed to
minimize sample contamination with CMC.
Galactose, glucosamine, maltose,
mannose, xylose
For detailed information – see
Reference Manual
.
Interference Tests in chapter 5 of the ABL800 FLEX
Erroneously high cGlu measurements.
1-6
ABL800 FLEX Operator's Manual 1. Introduction
Warning/Caution and Notices
Definitions
Throughout the manual, the various procedures may contain operational cautions
and warnings, which are important and should be read carefully before performing
the related procedures. The manual also contains a number of
NOTICES.
The following table indicates the type of information given in Warnings, cautions
and notes.
Symbol Explanation
WARNING
A warning alerts the reader about a situation, which, if not
avoided, could result in death or serious injury. It may also
describe potential serious adverse reactions and safety
hazards. The designation of a hazard alert as a "warning" is
reserved for the most significant problems. The term
WARNING is generally used as signal word for this type of
hazard alert.
CAUTION
The term precaution is used for the statement of a hazard
alert that warns the reader of a potentially hazardous
situation which, if not avoided, may result in minor or
moderate injury to the user or the patient or damage to the
equipment or other property. It may also be used to alert
against unsafe practices. This includes the special care
necessary for the safe and effective use of the device and the
care necessary to avoid damage to a device that may occur
as a result of use or misuse. The word
CAUTION is
generally used as signal word for a precaution statement.
NOTICE
Notices give practical information.
1-7
1. Introduction ABL800 FLEX Operator's Manual
Symbols overview
List of symbols
The symbols below are used by Radiometer.
Symbol Explanation
Biohazard
Expiry date
See instructions for use
For In Vitro Diagnostic Use
Lot number
Sensitive to light. Store in a dark place.
Code number
For single use only
Sterilized by ethylene oxide
Sterilized by irradiation
Storage temperature from 2
°C to 32 °C (36 °F to 90 °F)
Waste of Electrical and Electronic Equipment (WEEE)
The symbol indicates that:
• Radiometer Medical ApS and its distributors
within the European Union (EU) and associated
states have taken the necessary steps to comply
with the directive, 2002/96/EC on waste electrical
and electronic equipment (WEEE).
• The instrument, when reaching its end of life,
must be collected and recycled separately from
other waste according to national requirements.
Please contact your local Radiometer distributor
for instructions.
1-8
Environmental implications:
WEEE contains materials that are potentially hazardous to
the environment and to human health.
Overview
Introduction
Contents
2. What is what
The ABL800 FLEX analyzer is a complete unit comprised of several different
modules each performing a specific function and controlled by comprehensive
software. The modules are collected into well-defined sections according to their
related function.
This chapter describes the basic parts of the ABL800 FLEX analyzer and its
software.
This chapter contains the following topics.
Analyzer - front................................................................................................ 2-2
Analyzer - rear ................................................................................................. 2-4
Measuring section ............................................................................................ 2-5
Inlet module ..................................................................................................... 2-7
FLEXQ module ................................................................................................ 2-8
Thermal printer ................................................................................................ -10 2
Communication ports....................................................................................... -11
Barcode reader ................................................................................................. -13
AutoCheck module........................................................................................... -14
Screen elements................................................................................................ -15
Menu structure ................................................................................................. -24
Analyzer status................................................................................................. -28
Online aid facilities.......................................................................................... -36
Sample counter................................................................................................. -39
2
2
2
2
2
2
2
2
2. What Is what ABL800 FLEX Operator's Manual
A
Analyzer - front
Parts and
functions
The components of the analyzer front (with covers) is shown below.
Touch screen
Cover with
window
Thermal printer
Left cover
Waste container
Capillary inlet
Syringe inlet
Right cover
Cleaning Solution
Rinse Solution
FLEXQ module
Barcode reader
utoCheck
module
Cal 1
solution
Cal 2
solution
Part Function
Color touch screen 10.4" LCD for operation and management of the
analyzer.
Thermal printer For automatic printout of data.
Left cover To access the waste container/Rinse Solution.
Waste container For waste collection. A sensor detects when container is
full, and a message is displayed on the screen.
Rinse Solution For rinsing the liquid transport system after various
analyzer activities.
2-2
FLEXQ module See FLEXQ module in this chapter.
Barcode reader See Barcode reader in this chapter.
AutoCheck module See AutoCheck module in this chapter.
Cal 1 Solution For performing 1- and 2-point calibrations.
Cal 2 Solution For performing 2-point calibrations.
Cleaning Solution For cleaning the liquid transport system of lipid deposits.
Right cover To access solutions and pumps – see overleaf.
Syringe inlet flap Lift to introduce syringe samples and quality control
solutions.
Capillary inlet flap Lift to introduce capillary samples.
Cover with window See Measuring Section in this chapter.
Continued on next page
ABL800 FLEX Operator's Manual 2. What Is what
Analyzer - front, Continued
Parts and
functions
(continued)
The components of the analyzer front (without covers) is shown below.
pH/BG module
El/Met module
CD-ROM drive
Inlet module
Met II module
Oximetry module
Solution pump
Waste pump
Magnets
Part Function
Inlet module Accepts samples from a syringe/test tube or a capillary – see
Inlet Module in this chapter.
CD-ROM drive For storing data on a CD-RW disk or retrieving data from a
CD (e.g. installation software).
CAUTION – Installation of correct software
Install only software which is strictly intended for
use with the analyzer. Installation of other types may
affect analyzer performance.
pH/Blood Gas
(BG) module
Electrolyte/Metabolite (El/Met)
Measures pH, pO
component detail.
2+
Measures cCa
, cK+, cNa+, cGlu and cLac. See measuring
section detail.
, pCO2 and cCl–. See measuring
2
module
Met II module Measures creatinine.
(Only available for the ABL8x7 FLEX analyzers)
Oximetry (Oxi)
module
Measures ctHb, sO
FHbF and ctBil. See measuring component detail.
, FHHb, FO2Hb, FCOHb, FMetHb,
2
Solution pump Transports solutions through the liquid transport system.
Waste pump Transports liquid to the waste container.
Magnets Hold the covers in place.
2-3
2. What Is what ABL800 FLEX Operator's Manual
r
r
Analyzer - rear
Parts and
functions
The parts and components of the analyzer's rear panel are shown below.
Gas 1 cylinde
Gas 2 cylinde
Communication ports
Fan
Gas cylinder sockets
Power switch
Power socket
Part Function
Gas 1 cylinder Contains a gas mixture of 5.61 % CO
74.64 % N
.
2
, 19.76 % O2; balance
2
Gas 2 cylinder Contains a gas mixture of 11.22 % CO2, < 0.04 % O2;
balance > 88.74 % N
.
2
Fan For cooling internal components.
Gas cylinder
For mounting the gas cylinders.
socket
Communication
See section Communication Ports in this chapter.
ports
Power switch
For turning the analyzer on (position I) and off (position O).
Power socket For connecting the power cord.
In USA: If source is 120 V, use Radiometer cord 615-403
with parallel blade attachment plug.
If source is 240 V, use Radiometer cord 615-405
with tandem blade attachment plug.
2-4
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