ABL90 FLEX operator’s manual

ABL90 FLEX
operator’s
manual

ABL90 FLEX 1. Introduction

Operator's 7. Replacements

manual
8. Disk functions
From software version 2.3

2. What is what

3. Analyzer status

4. Sample measurements

5. Quality management
 6. Calibration

9. Data management

10. Analyzer shutdown

11. Troubleshooting

12. Sampling

13. Specifications

14. Ordering information

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 ABL90 FLEX analyzer comprises the Microsoft® Windows®XP Embedded 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) 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. Sybase® SQL Anywhere® is a 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 dama- ges, 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.

© 2009 Radiometer Medical ApS. All rights reserved.

End-user license agreement for the ABL90 FLEX analyzer

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 OF 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 environmental 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 U.S. TWO HUNDRED AND FIFTY DOLLARS (USD 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
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For additional information on exporting the SOFTWARE, see http://www.microsoft.com/exporting/.
ABL90 FLEX operator's manual Contents
 Contents

1. Introduction.....................................................................................1-1

ABL90 FLEX analyzer documentation.................................................... 1-2

Names and intended use.................................................................... 1-3

Names......................................................................................... 1-3 Intended
use................................................................................ 1-3 Sensor cassette
variants ................................................................ 1-4 Solution
pack ............................................................................... 1-4 Requirements to the
operator ......................................................... 1-4 Measurements on animal
blood ....................................................... 1-4 Limitations of use and known interfering
substances .............................. 1-5 Limitations of
use.......................................................................... 1-5 FHbF
measurement ....................................................................... 1-5 Known interfering substances
......................................................... 1-5 Symbols used on the analyzer and
accessories ...................................... 1-6

Symbols used in this manual .............................................................. 1-8

Definitions ................................................................................... 1-8 2. What is
what ....................................................................................2-1

Hardware......................................................................................... 2-2

Front............................................................................................... 2-2

Top................................................................................................. 2-3

Rear................................................................................................ 2-4 Detachable power

supply cord......................................................... 2-5 Inlet
module .................................................................................... 2-6

Built-in sample mixer ........................................................................ 2-7

Barcode reader ................................................................................. 2-8

Consumables.................................................................................... 2-9

Conditioning unit with sensor cassette.................................................. 2-9

Solution pack ..................................................................................2-10

Software.........................................................................................2-11

Screen elements ..............................................................................2-11 Main

screen.................................................................................2-11 Top
section .................................................................................2-11 Center
section .............................................................................2-12 Bottom
section ............................................................................2-15 Initial
logon.....................................................................................2-17 Access
rights ...............................................................................2-17 Entering standard
password...........................................................2-17 Menu
structure ................................................................................2-18

3. Analyzer status ................................................................................3-1

Analyzer status at a glance................................................................. 3-2

 Analyzer status elements ................................................................... 3-3

Calibration status.............................................................................. 3-4

Quality control (QC) .......................................................................... 3-5

Replacement .................................................................................... 3-6

Contents ABL90 FLEX operator's manual

Other activities ................................................................................. 3-7

System messages ............................................................................. 3-7

4. Sample measurement ......................................................................4-1

General information........................................................................... 4-2

General information........................................................................... 4-2 Available modes and

parameters..................................................... 4-2 Immediately before
analysis ............................................................... 4-3

Introducing a blood sample with a standard syringe ............................... 4-4

Introducing a blood sample with a safePICO sampler with barcode ........... 4-5

Introducing a blood sample with a safePICO sampler with barcode and sample pre-
registration...................................................................... 4-6

Introducing a blood sample with a capillary tube ................................... 4-8

Introducing a blood sample with a test tube.......................................... 4-9

Entering patient identification ............................................................4-10 Entering information with

barcode reader ........................................4-10 Entering information
manually .......................................................4-10 Patient
lookup .............................................................................4-11 Selecting a report
layout ...............................................................4-12 De-selecting parameters after a

measurement .................................4-12 Determining FShunt and ctO2(a-v–

).................................................4-13 Calculation

of ..............................................................................4-13 FShunt and ctO2(a-

v–) ...................................................................4-13 Patient

result...................................................................................4-14
Program .....................................................................................4-14 Parameter
status .........................................................................4-14 Recalling patient
ID......................................................................4-15 Patient result
approval..................................................................4-16 Acid-Base
chart ...........................................................................4-17 Patient result audit
trail ................................................................4-18 Patient result
messages ....................................................................4-19 Screen
messages .........................................................................4-19 5. Quality
management........................................................................5-1

Automatic quality management system ................................................ 5-2

General information........................................................................... 5-3

 Purpose ....................................................................................... 5-3 Glossary
list ................................................................................. 5-3 Built-in quality
control ....................................................................... 5-4
Schedule ..................................................................................... 5-4 Acceptable
ranges......................................................................... 5-4 Built-in QC
measurement ............................................................... 5-4 View built-in QC
results.................................................................. 5-4 Parameter
status .......................................................................... 5-5 Unscheduled built-in QC
measurement............................................ 5-5
Reference .................................................................................... 5-5 System
checks ................................................................................. 5-6
Description................................................................................... 5-6 Analysis
check.................................................................................. 5-7
Description................................................................................... 5-7 Manual quality
control ....................................................................... 5-8

Manual quality control ....................................................................... 5-8 Required

materials ........................................................................ 5-8
ABL90 FLEX operator's manual Contents

Before measurement on a control solution ........................................ 5-8 Introducing a QC

solution............................................................... 5-9 Entering information with barcode
reader ......................................... 5-9 Entering information
manually .......................................................5-10 View manual QC
results ................................................................5-10 Parameter
status .........................................................................5-10 Unknown
solutions .......................................................................5-11 Temperature
corrections ...............................................................5-11
Reference ...................................................................................5-11 Recalling quality control
identification .............................................5-11 Additional quality
control...................................................................5-12

6. Calibration .......................................................................................6-1

General information........................................................................... 6-2

Purpose ....................................................................................... 6-2 Calibration
programs ..................................................................... 6-2 Calling an unscheduled
calibration ................................................... 6-2 Calibrations related to
startups ....................................................... 6-2 Pending
calibrations ...................................................................... 6-2 Expired
calibrations ....................................................................... 6-3 tHb
calibration.................................................................................. 6-4
Purpose ....................................................................................... 6-4
Preparation .................................................................................. 6-4 tHb calibration
procedure ............................................................... 6-4 Calibration
result .............................................................................. 6-5 Viewing a calibration
result............................................................. 6-5 Calibration
result .......................................................................... 6-5 tHb calibration
result ..................................................................... 6-6 Calibration result
messages ............................................................ 6-7 Calibration
verification ....................................................................... 6-8
Purpose ....................................................................................... 6-8 Preparatory
steps.......................................................................... 6-8 Verification
procedure...................................................................6-10 7.
 Replacements...................................................................................7-1

Screens during replacements .............................................................. 7-2

Replacements................................................................................... 7-3 Viewing replacement

status ............................................................ 7-3 Solution
pack ................................................................................... 7-4 Replacing solution
pack.................................................................. 7-4 Manual release of the solution
pack ................................................. 7-5 Sensor
cassette ................................................................................ 7-5 Conditioning sensor
cassette........................................................... 7-5 Replacing sensor
cassette............................................................... 7-7 Sensor startup after
replacement ........................................................ 7-9

Printer paper ...................................................................................7-10 Replacing printer

paper.................................................................7-10
Inlet...............................................................................................7-11 Replacing the
inlet .......................................................................7-11 Replacing inlet
probe/gasket..........................................................7-13 Replacing the inlet connector
gasket ...............................................7-14 Cleaning the
analyzer .......................................................................7-17 Cleaning the
inlet.........................................................................7-17 Cleaning the sensor cassette
seat...................................................7-17 Cleaning the analyzer
exterior .......................................................7-17 Cleaning the analyzer
screen .........................................................7-18 Disinfection of outer
surfaces.........................................................7-18
Contents ABL90 FLEX operator's manual

8. Disk functions ..................................................................................8-1

General information........................................................................... 8-2 Disk functions

programs................................................................. 8-2 9. Data
management............................................................................9-1

General information........................................................................... 9-2 Access to data

logs........................................................................ 9-2 Archived data
logs......................................................................... 9-2 Patient results
log ............................................................................. 9-3
Purpose ....................................................................................... 9-3
Functions..................................................................................... 9-4 Filter
function ............................................................................... 9-4 Trend
function .............................................................................. 9-5 Patient profiles
log ............................................................................ 9-6 About a patient
profile ................................................................... 9-6 Patient profiles
log ........................................................................ 9-6 Editing a patient
profile.................................................................. 9-7 Adding a new patient
profile ........................................................... 9-7 Deleting a patient
profile................................................................ 9-7 Finding a patient
profile ................................................................. 9-8 Quality control
log............................................................................. 9-9
Purpose ....................................................................................... 9-9 Quality control
plot.......................................................................9-10 Filter/trend
function .....................................................................9-11 Viewing quality control
statistics.....................................................9-12 Printing QC
statistics ....................................................................9-14 Calibration
 log .................................................................................9-15
Purpose ......................................................................................9-15 Filter
function ..............................................................................9-16 Trend
function .............................................................................9-17 Activity
log......................................................................................9-18
Purpose ......................................................................................9-18 Adding a message to the
log..........................................................9-18 Filter
function ..............................................................................9-19 Replacement
log ..............................................................................9-20 Replacement
log ..........................................................................9-20 Archived data
logs............................................................................9-21
Purpose ......................................................................................9-21 Selecting an archive saved on
the analyzer......................................9-21 Moving an archive to another media or from another
media to the analyzer .....................................................................................9-22 Converting an
archive into .csv format ............................................9-22 RADIANCE browser
(optional) ............................................................9-23
Purpose ......................................................................................9-23 Accessing
RADIANCE ....................................................................9-23 10. Analyzer
shutdown ........................................................................10-1

General information..........................................................................10-2 Shutdown

programs .....................................................................10-2 Temporary
shutdown........................................................................10-3
Purpose ......................................................................................10-3 Switching off the
analyzer for a short time.......................................10-3 Restarting the analyzer after temporary
shutdown ................................10-4

Long-term shutdown ........................................................................10-5

Purpose ......................................................................................10-5 Storing an
analyzer ......................................................................10-6 Transporting the
analyzer..............................................................10-6
ABL90 FLEX operator's manual Contents

Restarting the analyzer.................................................................10-6 11.

Troubleshooting ............................................................................. 11-1

General information..........................................................................11-2

General information..........................................................................11-2 Analyzer action in case of

error ......................................................11-2 Operator actions in case of
error ....................................................11-2 Logging system
messages .............................................................11-3 User-intervention-required
causes ......................................................11-4
Purpose ......................................................................................11-4 12.
Sampling ........................................................................................ 12-1

Sampling devices and procedures.......................................................12-2

Introduction ................................................................................12-2 Recommended arterial blood
samplers ............................................12-2 Recommended capillary blood
samplers...........................................12-2
Procedures..................................................................................12-3 Special considerations for
capillary specimens ..................................12-3 Storage time and temperature
recommendations..................................12-5 Radiometer storage recommenda-tions for whole-
blood samples.........12-5 Special considerations ..................................................................12-5
Causes of error in the preanalytical phase ...........................................12-6
 Introduction ................................................................................12-6 Possible causes of
error ................................................................12-6
References......................................................................................12-9 List of
references .........................................................................12-9 Recommended
literature ............................................................. 12-10 13.
Specifications.................................................................................13-1

Measured parameters .......................................................................13-2

Blood .........................................................................................13-2
Barometer ..................................................................................13-3 Input
parameters.............................................................................13-4 List of
parameters........................................................................13-4 Derived
parameters......................................................................13-4 Sample
handling ..............................................................................13-5

Analyzer requirements......................................................................13-6 Analyzer

requirements..................................................................13-6 Analyzer
specifications......................................................................13-7
Specifications ..............................................................................13-7 Approvals and
patents ......................................................................13-8
Approvals ...................................................................................13-8 CE-
mark .....................................................................................13-8 EMC
emission ..............................................................................13-8 EMC
immunity .............................................................................13-8
Patents.......................................................................................13-8 14. Ordering
information .....................................................................14-1

Analyzer accessories.........................................................................14-2
Analyzer .....................................................................................14-2 Sensor
cassette ...........................................................................14-2 Solution
pack ..............................................................................14-2 Power
cords ................................................................................14-2 Other
accessories.........................................................................14-3
Documentation ............................................................................14-3 Quality
control.................................................................................14-4
Accessories .................................................................................14-4
Contents ABL90 FLEX operator's manual

QUALICHECK5+ solution................................................................14-4 Range+

QUALICHECK solution .......................................................14-4 Metabolite+ QUALICHECK
solution..................................................14-4
Documentation ............................................................................14-4 Sampling
devices .............................................................................14-5 Arterial blood gas
samplers ...........................................................14-5 Capillary samplers,
glass...............................................................14-5 Capillary samplers,
plastic.............................................................14-5 safePICO
samplers .......................................................................14-6

Index

Date of issue
ABL90 FLEX operator's manual Contents

1. Introduction
ABL90 FLEX analyzer documentation.......................................................... 1-2

Names and intended use.......................................................................... 1-3

Limitations of use and known interfering substances .................................... 1-5

Symbols used on the analyzer and accessories ............................................ 1-6

Symbols used in this manual .................................................................... 1-8

NOTICE: The screen shots shown in this manual do not necessarily reflect the screens you
will see on your analyzer. The screen shots are based on a full parameter panel, and some of
the screen shots may be from an analyzer setup different from yours.
 1-1
1. Introduction ABL90 FLEX operator's manual

ABL90 FLEX analyzer documentation

1-2

The documentation that accompanies the ABL90 FLEX analyzer includes practical and theoretical information
regarding the function and use of the analyzer.
The table below describes documentation available for this analyzer.
Documentation Description
Operator’s manual • Contains the instructions of use for point-of-care
information, i.e. all the information required for everyday operation of the analyzer
• Describes the functions of the analyzer
• Explains error messages and gives troubleshooting procedures
Reference manual • Provides detailed information about the operating
principles of the analyzer and contains reference material not required for the everyday operation of the analyzer
• Describes setup and the disk functions setup programs
• Describes the measuring and calibrating principles
• Lists all the parameters
• Provides the equations from which the derived parameters are calculated
• Provides information about how the performance of the analyzer is tested
ABL90 FLEX operator's manual 1. Introduction

Names and intended use

Names
Proprietary name: ABL90 FLEX blood gas, oximetry, electrolyte and
metabolite analyzer.
Common name: Blood gas, oximetry, electrolyte and metabolite
measuring system.
Intended use
The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose,
lactate, bilirubin and oximetry in whole blood.
The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists.
It is intended for use in a laboratory environment, near patient or point-of-care setting.
The ABL90 FLEX analyzer can be connected to the RADIANCE system. The Radiance system enables
communication between the RADIANCE server and the ABL90 FLEX analyzer to allow remote data entry and
analyzer access.
These tests are only performed under a physician's order.
In the table below the measured parameters are shown:
Parameter
Parameter group
pH/blood gas:
pH (acidity)
pCO2 (carbon dioxide tension)

pO2 (oxygen tension)

Oximetry:
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)
ctBil (concentration of total bilirubin in plasma)
Electrolytes:
cK+ (potassium ion concentration)
cNa+ (sodium ion concentration)
cCa2+ (calcium ion concentration)
cCl– (chloride ion concentration)
Metabolites:
cGlu (D-glucose concentration) cLac (L(+)-lactate concentration)
For details on derived parameters, see section Derived parameters in chapter 8: Parameters in the ABL90 FLEX
reference manual.
1-3
1. Introduction ABL90 FLEX operator's manual
1-4 Sensor
The ABL90 FLEX analyzer comes with different parameter panels, depending on cassette
the sensor cassette installed. variants
The sensor cassettes are available in the following parameter configurations:
Configuration Parameters
BG/OXI + QC pH, pCO2, pO2, ctBil, ctHb, sO2, FO2Hb,
FMetHb, FCOHb, FHHb, FHbF
BG/LYT/OXI + QC pH, pCO2, pO2, cCa2+, cCl–, cK+, cNa+, ctBil,

ctHb, sO2, FO2Hb, FMetHb, FCOHb, FHHb, FHbF

BG/LYT/MET/OXI + QC pH, pCO2, pO2, cCa2+, cCl–, cK+, cNa+, cGlu,

cLac, ctBil, ctHb, sO2, FO2Hb, FMetHb, FCOHb, FHHb, FHbF

For details on the different sensor cassette variants, see section Analyzer accessories in chapter 14: Ordering
information.
Solution pack
All solutions necessary for the daily operation of the ABL90 FLEX analyzer are contained in the solution pack, e.g.
calibration, rinse and quality control solutions. Apart from solution consumption in connection with a test, solution is
consumed during a number of automatic activities (e.g. calibration and quality control) that runs at fixed intervals.
The solution pack contains solutions for 600 activities (tests and automatic activities) and has a max. lifetime of 30
days. The analyzer performs 12 auto activities per day. This means that the higher the daily sample volume is, the
more tests can be performed per solution pack – and the shorter the lifetime.
Requirements
The analyzer should be used by personnel trained in using in vitro diagnostic to the operator
medical devices.
NOTICE: Documentation must be consulted. Failure to follow the instructions in the manual may result in damage to
the analyzer. Radiometer will not accept warranty claims or product liability claims if the recommended procedures
are not followed.
Measurements
Animal blood has not been tested on the ABL90 FLEX analyzer. Animal blood on animal
differs from human blood, and variations in the composition of blood from blood
different animal species may also exist.
ABL90 FLEX operator's manual 1. Introduction

Limitations of use and known interfering substances

Limitations of
The following limitations should be taken into consideration: use
CAUTION – Fulfillment of user-specific analytical needs Review the analyzer's performance data to ensure that
the performance fulfills the user-specific analytical needs.
FHbF
The uncertainty in FHbF measurements exceeds the level required to measure measurement
normal HbF levels in the adult range (FHbF reference range is 0-1 %). FHbF is disabled as default.
The ABL90 FLEX analyzer measures only HbA and HbF hemoglobins.
Known
For information on the interfering substances, see section Interference tests in interfering
chapter 7: Performance characteristics in the ABL90 FLEX reference manual. substances
1-5
WARNING – Clinical decisions The validity of the test results from this analyzer must be carefully examined by a
clinician and related to the patient's clinical condition, before any clinical decisions are made on the basis of the test
results.
1. Introduction ABL90 FLEX operator's manual

Symbols used on the analyzer and accessories

1-6 Symbol Explanation
VGA (monitor)
COM port (scanner/barcode reader)
IOIOI
UL certification
Biological risk
Caution
Consult accompanying documents
USB
Product code no.
Lot no.
Waste electrical and electronic equipment
• Radiometer Medical ApS and its distributors within the European Union and associated states have taken the
necessary steps to comply with the directive, 2002/96/EC on waste electrical end 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.
Environmental implications: WEEE contains materials that are potentially hazardous to the environment and to
human health.
Network
Keyboard
Mouse
Mark of compliance with applicable EU Directives
In vitro diagnostic use
Manufactured by
ABL90 FLEX operator's manual 1. Introduction

Symbol Explanation
 1-7
Syringe position of inlet

Capillary position of inlet

Sample mixer
1. Introduction ABL90 FLEX operator's manual

Symbols used in this manual

Definitions 1-8
erational warnings and cautions, which are important and should be
rforming the related procedures. The manual also contains
nd a number of helpful hints, signaled by the word NOTICE.

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.

Manufactured by

2. What is what

Hardware............................................................................................... 2-2

Front............................................................................................... 2-2

Top................................................................................................. 2-3

Rear................................................................................................ 2-4

Inlet module..................................................................................... 2-6

 Built-in sample mixer......................................................................... 2-7

Barcode reader................................................................................. 2-8

Consumables.......................................................................................... 2-9

Conditioning unit with sensor cassette.................................................. 2-9

Solution pack ..................................................................................2-10

Software...............................................................................................2-11

Screen elements ..............................................................................2-11

Initial logon...........................................................................................2-17

Menu structure ......................................................................................2-18

2-1
2. What is what ABL90 FLEX operator's manual
 Hardware sensor cassette T

2-2

Front
e color touch screen T

(optional)
eader T

The battery pack enables, for a limited period of time, the

mple mixer
performance of measurements and the storage of data without the
T

analyzer being connected to mains or during power failure.

ABL90 FLEX operator's manual 2. What is what

Top
 2-3
1 Handle T

2 USB port T

3 Thermal printer T

2. What is what ABL90 FLEX operator's manual

Rear External VGA monitor port – for test purposes only.

2-4
lO

Latch for manual release of the solution pack T

– on some versions the mains power

switch may show "ON" and "OFF" instead of "l" and "O". T

utton

rt T

port T

ABL90 FLEX operator's manual 2. What is what

NOTICE: The analyzer should always be placed so that power can be easily switched off in emergency situations,
and so that the ventilation is not covered.
Detachable power supply cord
For US
UL listed and KAM cord, min. type SV, 18 AWG, 3 (125 VAC)
conductors. Rated min. 60 °C.
Provided with a molded grounding-type (NEMA 5-15P) attachment plug rated 125 VAC, min 2.5 A.
Opposite end terminates in molded IEC 320-style connector rated 125 VAC, min. 2.5 A.
For Europe (265 VAC) T

2
2-5 Cord type min. H05RR-F or min. H05VV-f or min. H05VVH2-F, rated min. 60 °C, 2 × 0.75 mm .
Provided with a molded grounding-type attachment plug rated min. 250 VAC, min 2.5 A.
Opposite end terminates in molded IEC 320-style connector rated min. 250 VAC, min. 2.5 A.
NOTICES: • External computing devices connected to the equipment must
T

comply with the standard, UL 60950 for US and IEC 60950 for Europe. Failure to do so may result in equipment
damage.
• The mains supply cord and plug of the equipment must comply with any national regulation. Failure to do so may
result in equipment damage.
CAUTION: Outside patient environment, place the ABL90 FLEX analyzer minimum 1.5 meters from patient bed. T

2. What is what ABL90 FLEX operator's manual

Inlet module before measurement.

2-6
Inlet gasket with holder for sample aspiration
on the inlet cover that illustrate inlet handle
(syringe, capillary, test tube or QUALICHECK adapter)
positions.
Inlet handle position LEDs
hat is lifted into syringe or capillary position
T

ABL90 FLEX operator's manual 2. What is what

Built-in sample mixer
 2-7
1 Built-in sample mixer

If a safePICO sampler is placed in the sample mixer, the ABL90

FLEX analyzer will automatically mix the blood sample.

Only safePICO samplers can be mixed in the sample mixer.

2. What is what ABL90 FLEX operator's manual
Barcode reader

1 Barcode reader
Hold the barcode parallel to the barcode reader. A short beep indicates that the information has been read
successfully.
Barcodes are found on the following ABL90 FLEX accessories:
Item Barcode position
Sensor cassette The label on the sensor cassette conditioning unit.
QC ampoules The insert in the box with ampoules.
tHb calibration ampoules 2-8 The insert in the box with ampoules. Sampler On the syringe cylinder.
The barcode information may also be entered manually in the input fields on the Patient profile, Patient ID, QC
solutions and Replacement screens – see section Miscellaneous setup in chapter 1: Setup in the ABL90 FLEX
reference manual.
ABL90 FLEX operator's manual 2. What is what

Consumables

Conditioning unit with sensor cassette

 2-9
1 Conditioning unit

The sensor cassette is delivered in a conditioning unit. The

sensor cassette can be conditioned in the conditioning unit. For
further information about the conditioning of the sensor cassette
and about how to remove the sensor cassette from the
conditioning unit see Sensor cassette in section Replacements in
chapter 7: Replacements in this manual.

Sensor cassette: T

1 Reference lid T

2 Electrical contact to sensors T

3 Oxygen sensor T

2. What is what ABL90 FLEX operator's manual

Solution pack
2-10
1 Biohazard label

Before installation of the solution pack, remove the top cover of

the label on top of the solution pack, so that the biohazard label
appears, to remind you that the solution pack must be disposed
of as infectious waste after use.

2 Safety pin

To activate a new solution pack, remove the safety pin and press
the lid down (see Solution pack in section Replacements in
chapter 7: Replacements in this manual for further information).
ABL90 FLEX operator's manual 2. What is what

Software

Screen elements

Main screen 3

1
2 3

Top section
4
1 Top section – see below T

2 Center section – see later in this chapter T

3 Bottom section – see later in this chapter T

The main screen appears automatically if the touch screen is idle for more than 3 minutes.

1 Status bar describing the current task of the analyzer

(e.g. calibration, measurement) or its status (e.g. ready for
use, locked).

2 Time bar seen only when the analyzer is performing

an activity. The time bar follows the progress of the task.

3 Parameter bar listing all measurement parameters

available and activated on your analyzer. You may judge the
parameter status at a glance before you perform a
measurement.

4 Shows the number of remaining tests and activities.

2. What is what ABL90 FLEX operator's manual
 2-12
Parameter status: TT

Green parameter cannot be used at all and will be displayed as "....."; or

Parameter status is okay; no problem detected on the given a parameter was repressed in the Parameter setup program (see
measuring channel. Parameters and input setup, chapter 1: Setup in the
ABL90 FLEX reference manual).
Yellow Error associated with the given parameter during the last
calibration or quality control measurement. The parameter is
unreliable and will have a "?" in front of the result (if requested in
the Corrective actions program (see section Corrective actions,
chapter 1: Setup in the ABL90 FLEX reference manual)).

Serious error associated with the given measuring channel. The Red

A parameter disabled in the Parameter setup program will be removed from the parameter bar
– see Disabled versus deselected parameter in section Analysis setup in chapter 1: Setup in
the ABL90 FLEX reference manual.

The buttons can be selected in the Access profiles setup programs together with the access
profiles for each operator – for detailed information, see the description in Access profiles in
section Analyzer security in chapter 1: Setup in the ABL90 FLEX reference manual.

Center section 1 23

1 Icon that describes the screen; it is the same as the button that gives access
to that screen.

2 Screen header (or name).

3 Navigation buttons – see below.

ABL90 FLEX operator's manual 2. What is what

Navigation tools
 2-13
...Left/right single-arrow scroll buttons that
move a text box horizontally when the box
extends beyond the area available on the
screen.

Interaction tools – text boxes TT

In this text box you can select one of the

predefined options. Use the up/down
arrows to select an item.

If the text box already contains an entry, it

will be overwritten and cannot be retrieved.

In this manual, text boxes are written in inverted commas, e.g. "Operator". The same applies to
the other elements in the center section of the screen: names of the columns (e.g. "Status"),
input fields (e.g. "Draw time"), etc.
The first line is highlighted on the screen.
To highlight another line, touch it on the
screen or use...

... Up/down single-arrow scroll buttons

that highlight one item at a time upward or
downward.

... Page up/down double-arrow scroll

buttons that highlight an item at the top
 or the bottom of each screen.

The first line is highlighted. To highlight

another line, use the up/down arrows or
touch the line in the box.

Enter the data using the screen keypad

or screen keyboard.
2. What is what ABL90 FLEX operator's manual
2-14
Interaction tools – check buttons

With the check buttons you can enable/disable or select/deselect an item on the screen. For
example:

A parameter is deselected.

Interaction tools – screen keypad

A parameter is selected.
A function is selected (e.g. acoustic signal if the inlet remains open) or
activated (e.g. communication with the RADIANCE system).

A function is deselected or deactivated.

Keypad with numerical buttons.

Depending on the screen, the decimal

point may be absent, e.g. Time/Date
setup.

Press the Backspace button to delete a

character from right to left. The box is
cleared as soon as the first character is
typed.

Press Enter (or Select in some cases) to confirm a numerical entry and to highlight the next line in the text box.
 To get access to an alphanumerical
keyboard press the keyboard icon.
ABL90 FLEX operator's manual 2. What is what

Interaction tools – screen keyboard TT

Bottom section
To enter alphanumerical text, key in the text and p
to return to the analyzer screen

To return to the previous screen, without making any entries/changes to already

entered text, press Esc.

• Each button has an icon and a name placed on it. When pressed, it opens or closes a
screen or a menu.

• The buttons are designated in bold italics in this manual, e.g. Menu, Utilities, etc.
 • The buttons displayed in full color can be activated. A grayed-out button is currently
inactive.

• The buttons can be selected in the Access Profiles setup program together with the access
profiles for each operator – for detailed information, see the description in Access profiles in
section Analyzer security in chapter 1: Setup in the ABL90 FLEX reference manual.

Note the functions of the following buttons:

Returns you to the previous screen in the same program; e.g. in the
Patient Results log, it will return you from the Patient identification
screen to the Patient result screen.

Returns you to the Main screen.

2. What is what ABL90 FLEX operator's manual
 2-16
Information bar

The information bar is placed in the lower right corner of the screen.

1 23

1 Clock – shows the current time in the selected format.

2 Date – shows the current date.

3 RADIANCE System icon - shown in the information

bar if connection has been established.
ABL90 FLEX operator's manual 2. What is what

Initial logon

Access rights • Performing a measurement

e allowed at analyzer startup:

• Calling a calibration

• Viewing/Editing data in the data logs

• Performing a replacement

Entering
standard
password
 2-17
Step Action

1. Press Menu > Logon on the Main screen.

2. Type in the standard password: 123456 and confirm with Enter.

3. Press Menu to access the complete menu – see the previous page.

See General security in section Analyzer security in chapter 1: Setup in the ABL90 FLEX
reference manual for further information about the logon possibilities.

The access possibilities for each user and their passwords are entered in the Analyzer
Security setup programs – see section Analyzer security in chapter 1: Setup in the ABL90
FLEX reference manual.
2. What is what ABL90 FLEX operator's manual

Menu structure
When the analyzer is taken into use, only the following limited menu is available.
Press Menu.
Menu
Log on See chapter 2
Analyzer status See chapter 3 2-18 Latest result Data logs See chapter 9 T

Setup See chapter 1 in the

Utilities
ABL90 FLEX reference manual
Calibration programs
Start programs
Disk functions
See chapter 6
See chapter 8
Calibration tHb calibration
Sample counter See chapter 1 in the ABL90 FLEX reference manual
Auxiliary programs
Temporary shutdown See chapter 10 Rinse Liquid sensor adjust
Long term shutdown Pump calibration
See chapter 10 Tubing refill
RADIANCE browser See chapter 9
Patient results log
Patient profiles log
Quality control log
Calibration log
Activity log
Archived data logs

3. Analyzer status

Analyzer status at a glance....................................................................... 3-2

Analyzer status elements ......................................................................... 3-3

Calibration status.................................................................................... 3-4

Quality control (QC) ................................................................................ 3-5

Replacement .......................................................................................... 3-6

Other activities ....................................................................................... 3-7

System messages ................................................................................... 3-7

 3-1
3. Analyzer status ABL90 FLEX operator's manual

Analyzer status at a glance

3-2

The working condition of the analyzer is continuously monitored during its operation.
To evaluate the analyzer status at a glance before a measurement, use the following:
• Parameter bar
• Color of the traffic light on the Analyzer status button.
Analyzer status button
To enter the Analyzer status screen, press Menu > Analyzer status or press the Analyzer status button to access
the analyzer status directly. T

ABL90 FLEX operator's manual 3. Analyzer status

Analyzer status elements

 3-3
The black triangle indicates that
this is active

The traffic light color of the Analyzer status button is determined by the traffic light colors of the
following status elements:

Status element Color Indicates

Calibrations GREEN OK

YELLOW Error(s) in the last calibration and/or

calibration schedule reminders.

RED Parameters with errors are repressed.

Quality control GREEN OK

YELLOW Error(s) in the last QC measurement and/or

QC schedule reminders.

RED Parameters with errors are repressed.

Replacement GREEN No replacements due at the present time.

YELLOW A replacement is due.

Other activities GREEN No activities due at the present time.

YELLOW Activity overdue.

System messages GREEN No (critical) messages.

 YELLOW Non-critical messages.

RED Critical messages. The analyzer cannot

calibrate or measure.
3. Analyzer status ABL90 FLEX operator's manual

Calibration status

Calibration Type Lists the most recently performed calibration of each

type and its status:

Calibration was accepted.

? Error(s) detected during calibration.

Pending or overdue calibration. The last

calibration was accepted.

?
Pending or overdue calibration. The last
calibration was not accepted.

Last time The date and time that the last calibration of the
specified type was performed.

Next time The date and time that the next calibration of the
specified type is due according to the calibration schedule – see
section Calibration schedule setup chapter 1: Setup in the ABL90
FLEX reference manual.

Interval The time interval between calibrations as set up in the

calibration schedule.

Message Messages (if present) referring to a highlighted

calibration.

Buttons • Result: Press to see results

• Calibration: Press to start a highlighted calibration.

3-4
ABL90 FLEX operator's manual 3. Analyzer status

Quality control (QC)

3-5
Solution (built-in or ampoule-based)
The last quality control measurement had
?
errors, and the next measurement is overdue.
Lot The solution lot number for the slot.
Last time The time that the last measurement was performed.
Next time The next scheduled time to perform the measurement
on the slot – see Quality control schedule setup in section Quality control setup in chapter 1: Setup in the ABL90
FLEX reference manual.
QC messages Messages (if present) referring to a highlighted QC
measurement.
Buttons • Result: Press to see results
• Start QC: Press to start a QC measurement
• QC Plot: Press to view the plot for the highlighted QC solution.
Lists the quality control slot and its solution type along with its status:
The last measurement was accepted.
? One or more of the following occurred:
T

Error in the last calibration

Analyzer error during last QC measurement
A parameter measurement is outside the defined ranges, or a Westgard Rule or RiLiBÄK range has been violated (if
Westgard Rules or RiLiBÄK ranges have been selected)
The next measurement is overdue, and the previous measurement, if any, was accepted.
3. Analyzer status ABL90 FLEX operator's manual

Replacement
3-6

The printer paper is to be replaced as needed.

Replacement components message
Messages (if present) referring to an activity.
T

Solution pack status, replacement due date and the number of remaining activities.
Sensor cassette status, replacement due date and the number of remaining tests.
ABL90 FLEX operator's manual 3. Analyzer status

Buttons • Replace: Press to select one of the replacements or sensor cassette conditioning

• Status: Press to see status and replacement reasons of the

consumable selected

• Troubleshoot: Press to get troubleshooting information

for the message in question.

Replacement procedures – see chapter 7: Replacements.

Other activities
 Here it is possible to view the scheduled replacements and user activities (see Replacement
schedule setup and User activities in section Replacement setup in chapter 1: Setup in the
ABL90 FLEX reference manual) and to see, if any of the activities are overdue. To see only
overdue replacements/user activities press Reminders only.

System messages

Here it is possible to view and remedy analyzer messages (see Operator actions in case of error in section General
information in chapter 11: Troubleshooting in this manual and chapter 10: Analyzer messages
in the ABL90 FLEX reference manual).

3-7
3. Analyzer status ABL90 FLEX operator's manual
3-8

4. Sample measurement

General information................................................................................. 4-2

Immediately before analysis ..................................................................... 4-3

Introducing a blood sample with a standard syringe ..................................... 4-4

Introducing a blood sample with a safePICO sampler with barcode ................. 4-5

Introducing a blood sample with a safePICO sampler with barcode and sample pre-
registration ...................................................................................... 4-6

Introducing a blood sample with a capillary tube.......................................... 4-8

Introducing a blood sample with a test tube................................................ 4-9

Entering patient identification ..................................................................4-10

Patient result.........................................................................................4-14

Patient result messages ..........................................................................4-19

 4-1
4. Sample measurement ABL90 FLEX operator's manual

General information
Available
The modes and the measured parameters available on the ABL90 FLEX analyzer modes and
are listed below. parameters
Modes Parameters
Syringe – S 65μL,
Capillary – C 65μL 4-2 pH, FMetHb, pCO2, FHbF, pO2, cKctHb, +, cNasO+2, , FOcCa2Hb, 2+, cClFCOHb, –, cGlu, FHHb,
cLac, ctBil
Ampoule - QC All available
NOTICES: • Not all of the above parameters may be available on your
T

analyzer – it depends on your sensor cassette version

• FHbF is by default disabled
WARNING – Presence of glucolic acid
Never use the analyzer for lactate measurements if there is any suspicion of presence of glycolic acid in the blood as
e.g. in the case of ethylene glycol poisoning or xylitol infusion. Glycolic acid interferes with the lactate sensor,
resulting in erroneously high lactate readings.
ABL90 FLEX operator's manual 4. Sample measurement

Immediately before analysis

The blood sample must be mixed immediately before it is introduced into the analyzer to ensure
its homogeneity. If a sample is transferred from a sampler to the analyzer without having been
properly mixed, either the plasma phase or the packed red blood cells may be analyzed, making
the oximetry results meaningless.

safePICO sampler: Place the syringe in the built-in sample

mixer on the front of the analyzer. The mixer starts automatically
and stops when the sample has been sufficiently mixed.

Alternatively, invert the syringe repeatedly, roll it between

the palms of your hands and follow your standard operating
procedure.
 4-3
CAUTION – Relevant capillary tube volume
Too small capillary volume will give the “Insufficient sample” error.

See chapter 12: Sampling for guidelines on how to handle blood samples.

Before introducing the sample into the analyzer, check the availability and status of the
desired parameters. For detailed information, see chapter 3: Analyzer status in this
manual.
Capillary tube: Mix a capillary sample by gently moving the
mixing wire repeatedly along the length of the capillary with a
magnet. Then move the mixing wire to the end of the capillary
opposite to that from which the blood is to be aspirated.

Remove both capillary caps.

Test tube: Invert the test tube repeatedly. Then remove the cap.
4. Sample measurement ABL90 FLEX operator's manual

Introducing a blood sample with a standard syringe

Step Action

1. Check that the analyzer is in the Ready mode.

2. Lift the inlet to the syringe position and follow the on-screen
instructions.

3. Place the syringe tip firmly against the inlet gasket and press it
upwards while still holding on to the sampler cylinder.

The inlet probe extends into the syringe and the blood is
automatically aspirated.

NOTICE: Be careful not to bend the probe. Hold on to the syringe barrel and do
not press the plunger.

NOTICE: Make sure that the plunger is not pushed back by the probe.

NOTICE: When aspirating small blood volumes less than:

PICO50 samplers: 1.1 mL

PICO70/safePICO70 samplers: 0.7 mL,

make sure that the heparin coated fiber disk does not block the probe during
aspiration.

WARNING - Risk of erroneous results

 Press the inlet gasket totally up to make sure that the sample is aspirated correctly, i.e.
from the whole sample and not just the tip of the syringe. Otherwise this may lead to
erroneous tHb results. 4. When prompted by the analyzer, remove the sampler and
close the
inlet. 5. Enter the information needed on the Patient identification screen.

4-4
WARNING – Risk of infection To avoid the risk of infection take care
not to scratch or stab yourself on the probe.
ABL90 FLEX operator's manual 4. Sample measurement

Introducing a blood sample with a safePICO sampler with barcode T

Step Action

1. Check that the analyzer is in the Ready mode and scan the sampler
barcode (see Barcode reader in section Hardware, chapter 2: What is what). Do not
remove the safeTIPCAP, the analyzer probe will pierce the safeTIPCAP. 2. Lift the inlet
to the syringe position and follow the on-screen
instructions.

3. Place the safeTIPCAP tip

firmly against the inlet gasket and
press it upwards while still holding
on to the sampler cylinder. The
inlet probe extends into the
syringe and the blood is
automatically aspirated.

NOTICE: Be careful not to bend

 the probe. Hold on to the syringe
barrel and do not press the
plunger.

NOTICE: Make sure that the

plunger is not pushed back by
the probe.

WARNING - Risk of erroneous results

Press the inlet gasket totally up to make sure that the sample is aspirated
correctly, i.e. from the whole sample and not just the tip of the syringe.
Otherwise this may lead to erroneous tHb results.

4. When prompted by the analyzer, remove the sampler and close the
inlet.
5. Enter the information needed on the Patient identification screen.

4-5
NOTICE: When aspirating small blood volumes less than:

PICO50 samplers: 1.1 mL

PICO70/safePICO70 samplers: 0.7 mL,

make sure that the heparin coated fiber disk does not block the probe during
aspiration.

WARNING – Risk of infection To avoid the risk of infection take care

not to scratch or stab yourself on the probe.
4. Sample measurement ABL90 FLEX operator's manual

Introducing a blood sample with a safePICO sampler with

barcode and
sample pre-registration
Step Action
1. Check that the analyzer is in the Ready mode and scan the sampler
barcode (see Barcode reader in section Hardware, chapter 2: What is what). Do not remove the safeTIPCAP. 2.
If Sample pre-registration has not been selected: Proceed to step 3 below.
• If Sample pre-registration has been selected in the Sample pre- registration setup (see section Sample pre-
registration setup in chapter 1: Setup in the ABL90 FLEX reference manual): Proceed to step 3 below to start the
measurement or press Cancel to cancel the displayed patient data.
3. Lift the inlet to the syringe position and follow the on-screen
instructions.
Do not remove the safeTIPCAP.
4-6
ABL90 FLEX operator's manual 4. Sample measurement

Step Action

4. Place the safeTIPCAP tip firmly

against the inlet gasket and press it
upwards while still holding on to the
sampler cylinder. The inlet probe
extends into the syringe and the
blood is automatically aspirated.

NOTICE: Be careful not to bend the

probe. Hold on to the syringe barrel
and do not press the plunger.

NOTICE: Make sure that the plunger

is not pushed back by the probe.

WARNING - Risk of erroneous results

Press the inlet gasket totally up to make sure that the sample is aspirated correctly, i.e.
from the whole sample and not just the tip of the syringe. Otherwise this may lead to
erroneous tHb results. 5. When prompted by the analyzer, remove the sampler and
close the
inlet.

6. Enter the information needed on the Patient identification screen.

 4-7
NOTICE: When aspirating small blood volumes less than:

PICO50 samplers: 1.1 mL

PICO70/safePICO70 samplers: 0.7 mL,

make sure that the heparin coated fiber disk does not block the probe during
aspiration.

WARNING – Risk of infection To avoid the risk of infection take care

not to scratch or stab yourself on the probe.
4. Sample measurement ABL90 FLEX operator's manual

Introducing a blood sample with a capillary tube

Step Action
1. Check that the analyzer is in the Ready mode.
2. Mix the capillary sample by gently moving the mixing wire
repeatedly along the length of the capillary with a magnet. Then move the mixing wire to the end of the capillary
opposite to that from which the blood is to be aspirated.
3. Lift the inlet to the capillary position and follow the on-screen
instructions.
4.
Remove the capillary caps, if any, and press the capillary against the inlet gasket as shown.
NOTICE: To ensure the right positioning of the capillary tube, place it in the center of the inlet gasket conus. A slight
turn of the capillary tube when positioning it might assist with the centering.
The blood is automatically aspirated when the inlet gasket is pushed inwards.
4-8 5. When prompted by the analyzer, remove the capillary and close the
inlet.
6. Enter the information needed on the Patient identification screen.
WARNING - Risk of erroneous results
Gently press the inlet gasket totally in to make sure that the sample is aspirated correctly, i.e. from the whole sample
and not just the tip of the capillary tube. Otherwise this may lead to erroneous tHb results.
ABL90 FLEX operator's manual 4. Sample measurement

Introducing a blood sample with a test tube

Step Action

1. Check that the analyzer is in the Ready mode.

2. Lift the inlet to the syringe position and follow the on-screen
instructions.

3. Place the test tube opening firmly against the inlet gasket holder
and press it upwards while still holding on to the test tube. The inlet probe
extends into the tube and the blood is automatically aspirated.

NOTICE: Be careful not to bend the probe.

NOTICE: If the inlet probe has difficulties in reaching the blood sample, we
recommend that you transfer the blood sample to a smaller test tube, or,
alternatively, try to tilt the test tube a little, so that the inlet probe can reach into the
 blood sample.

4. When prompted by the analyzer, remove the test tube and close the
inlet. 5. Enter the information needed on the Patient identification screen.

4-9
4. Sample measurement ABL90 FLEX operator's manual

Entering patient identification

Entering 4-10
information with
barcode reader
Activate the "Enable general barcode support" function in the
Miscellaneous setup, if not done already (see chapter 1: Setup in the ABL90
FLEX reference manual).

2. Scan all barcodes, if available (e.g., Access

Entering
information
manually

Highlight the desired input field in the Patient identification list (the
top box is already highlighted when the Patient identification screen

Patient department, Patient last name, etc.) (see Barcode reader in section
Hardware, chapter 2: What is what) in the proper field.

3. Scan "Operator" or "Physician" from your ID card, if available.

• If the name is included in the list of the analyzer's registered users, the
barcode will identify the person and fill in the name automatically –
depending on the selected input layout

• If the name is not included in the list of the analyzer's registered users, only the
barcode will be read from the ID card

2. Type in the patient information, using the screen keypad or

keyboard, and confirm each entry with the Enter button.

• If a patient ID has been used before or is included in the Patient profile log, the
relevant input fields will be filled in automatically – see section Patient profiles log,
chapter 9: Data management in this manual.

• Press Patient lookup (if available) to obtain the latest information about your
patient – see the Patient lookup function below.
ABL90 FLEX operator's manual 4. Sample measurement
Step Action
3. The analyzer is connected to LIS/HIS and/or the RADIANCE system:
• Type in the Patient ID or Accession number. If automatic data request has been selected in Communications setup
(see Automatic data request setup in section Communications setup in chapter 1: Setup in the ABL90 FLEX
reference manual), the relevant input fields will be automatically filled in with data received from LIS/HIS or the
RADIANCE system.
Or
• Press Request (if available) – after the patient ID or Accession number has been entered – to fill the relevant text
boxes
4. Fill in all the mandatory (with a next to it) text boxes to view
the measurement results.
5. If desired, select another report layout (see next page, section
Selecting a report layout).
NOTICES: • If the requested patient data (e.g. Patient last name) was
received after the Patient identification screen was exited, the patient report will be transmitted without the
requested data. To prevent this, select one of the patient ID items transferred from LIS/HIS as mandatory.
• If the requested patient data (e.g. Patient last name) was received after the Patient identification screen was
exited, the patient report will be stored without the requested data in the Patient report log. The data will be stored as
a patient profile in the analyzer's database without, however, being attached to any patient report. The data can be
reused the next time the same patient ID is used.
Patient lookup
The Patient lookup function allows you to transfer the patient information from a department's specific list to the
Patient identification screen if the following conditions are fulfilled:
Item Conditions
Data source Should be selected in Patient lookup setup (see Patient lookup setup in section Communications setup,
chapter 1: Setup in the ABL90 FLEX reference manual for details) for the specified data source:
• LIS/HIS
• RADIANCE system
• Analyzer's local database
Exclude from
Number of days that you want each patient to be kept in patient list after ...
the list should be selected (see Patient lookup setup in section Communications setup, chapter 1: Setup in the ABL90
FLEX reference manual for details)
Department (Pat.) Must be included and filled in on the Patient
identification screen.
4-11
4. Sample measurement ABL90 FLEX operator's manual
4-12
Step Action
1. Highlight and fill in the "Department (Pat.)" field on the Patient
identification screen.
2. Press Patient lookup.
3. Select your patient from the list by highlighting the corresponding
line on the screen.
4. Press Update to update the Patient list.
5. • Press Select to transfer the specific patient information to the
Patient identification screen and return to the previous screen
Or
• Press Back to return to the previous screen without updating the patient information
Selecting a
Step Action report layout
1. Highlight "Report layout" with the up/down arrows on the Patient
identification screen.
2. • "Report layout" is included in the Patient ID:
Select a layout from the list displayed on the right side of the screen, using the up/down arrows. (The list of report
layouts has been made in the Patient report setup – see Patient report setup in section Analysis setup in chapter 1:
Setup in the ABL90 FLEX reference manual).
• "Report layout" is not included in the Patient ID: Highlight the line on the Patient identification screen (the input
field is separated from the rest of the items on the screen) and select the desired layout. The patient report will be
saved in this layout. Data not shown in the layout selected will still be archived.
 De-selecting
Step Action parameters after a
1. Press Parameters on the Patient identification screen. measurement
2. Deactivate the relevant check button to exclude a parameter.
3. • Press Back to return to the Patient identification screen
• Press Result to display the changed result
• Press Print to print out the changed patient report
NOTICE: The Selected parameters screen displays all the parameters selected in the Parameter profile for a given
measuring mode.
ABL90 FLEX operator's manual 4. Sample measurement

Determining FShunt and ctO2(a- v–)

Calculation of
To obtain the calculated values of FShunt and ctO2(a-v– ), it is necessary FShunt and ctO2(a-v–)
4-13 toanalyze a mixed-venous and an arterial (or capillary) blood sample from the patient.
Step Action
1. Make, if required, a new patient report layout (see Patient report
setup in section Analysis setup, chapter 1: Setup in the ABL90 FLEX reference manual) with the following parameters
included:
• FShunt and/or ctO2(a-v– ) into the Patient result

• pO2(v– ), sO2(v– ), FO2(I), RQ and T (patient temperature) into the Patient ID 2. Analyze the mixed-venous sample and

record the pO2(v– ) and

sO2(v– ). 3. Analyze the arterial sample.

On the Patient identification screen, select the sample type as
4.
"Arterial" or "Capillary" and key in the following values:
• pO2(v– ) and sO2(v– ) from the mixed-venous sample (step 2 above)

• FO2(I) if it differs from the default value of 0.21 (for FShunt)

• RQ if it differs from the default value of 0.86 (for FShunt)
• T if it differs from the default value of 37 °C (for FShunt)
NOTICE: The FShunt will be estimated if not all of the inputs (sO2(v– ), pO2(v– ), FO2(I), RQ) are given. A default value

for ctO2(a-v–) will be used if pO2(v– ) as well as sO2(v– ) are not input.
4. Sample measurement ABL90 FLEX operator's manual

Patient result

Program • Press Menu > Data logs > Patient results log, h
en will be displayed automatically when the measurement has been
he patient identification information took longer to enter than the
do one of the following:

• Press Result on the Ready screen

• Press Menu > Latest result

• Press Menu > My results

Parameter 4-14
status No marking next to a parameter indicates that a parameter was measured without any

The following markings may appear next to a parameter:

Marking Explanation

"?" • Error in the last quality control measurement or

calibration, or because of sample problems

• Sample age selected for the given parameter(s) in Sample logistics

setup (see Sample age evaluation setup in section Analysis setup in
chapter 1: Setup in the ABL90 FLEX reference manual) was exceeded

• Parameter value is outside the reference range (the range within

which the parameter value is considered normal, for the specific type of
sample being measured), but inside the critical limits

• Parameter value is outside the upper or lower critical limit (the limits
outside of which a parameter value is dangerously high or low, for the
specific type of sample being measured), but inside the reportable
range.
ABL90 FLEX operator's manual 4. Sample measurement
Marking Explanation
• Parameter value is outside the reportable range. The reportable range can be selected for all measured and
derived parameters.
• The values of a parameter with these markings are blanked out and hence not shown in the result. The markings
will, however, be printed together with the result.
"....." instead
• A parameter cannot be calculated or exceeds the of the value
numerical limit of the analyzer (range of indication)
"*" next to the value
4-15
• Values with user-defined correction factors
Recalling patient ID
To recall the Patient identification screen, press ID.
For detailed information, refer to the section Entering patient identification in this chapter. T

4. Sample measurement ABL90 FLEX operator's manual

4-16 Patientresult
Result approval is possible if the "Enable patient result approval" check button approval
has been activated in the Miscellaneous setup, and only if the analyzer is set up to LIS/HIS and the RADIANCE
system (see section Miscellaneous setup in chapter 1: Setup in the ABL90 FLEX reference manual).
Step Action
Press Approval on the Patient result screen to display the
1.
following functions:
2. • Approve Press Accept to accept the result and to send it to
the connected RADIANCE system or LIS/HIS.
Press the Keyboard icon to write a note.
Press Cancel to return to the previous screen.
• Reject Press Accept to reject the result and to send it to
the connected RADIANCE system or LIS/HIS.
Press the Keyboard icon to write a note.
Press Cancel to return to the previous screen.
• Rerun Press Accept to mark that the measurement
should be repeated, and to send it to the connected RADIANCE system or LIS/HIS.
Press the Keyboard icon to write a note.
Press Cancel to return to the previous screen.
• Note Press the Keyboard icon to type in a note prior to
the approval or to edit a highlighted note.
To delete a highlighted note, press the Keyboard icon and delete the note.
NOTICES: • Once the result has been approved/rejected/rerun, the ID
data can only be viewed, not changed (grayed-out input boxes). The Parameters, Patient lookup and Request
buttons will not be available either.
• In the Patient report log you can filter patient reports according to the approval status
• The button changes to Send after the approval of the patient result has been made (if selected in Communications
setup – see chapter 1: Setup in the ABL90 FLEX reference manual).
ABL90 FLEX operator's manual 4. Sample measurement
Acid-Base chart
4-17
on Press Acid-Base chart
the Patient result screen to view the acid- base chart for the selected patient result (the button will not be available if

pH and pCO2 have been deselected in the Parameter setup).

The sample type should be either "Arterial" or "Capillary".
The chart illustrates the patient result according to the Siggaard-Andersen nomogram. The clinical conditions
correspond to each of the eight zones listed to the right of the screen.
The point position is determined by the pH and pCO2 values from the patient result. If the pH and pCO2 values are

outside the defined limits of the acid-base chart, the message "Measurement out of range" will appear on the chart in
red and the Print button will disappear.
Available buttons
Press to...
Print print out the displayed acid-base chart and the
corresponding patient result, if available – see above. To print the acid-base chart automatically, activate the check
button in the Patient reports setup, (see chapter 1: Setup in the ABL90 FLEX reference manual).
Back to return to the patient result screen.
NOTICE: The information provided by the acid-base chart should only be used as a guideline for interpreting the
patient's condition. Patient results must always be examined carefully by a clinician before a diagnosis is made.
4. Sample measurement ABL90 FLEX operator's manual
4-18 Patient result
Any changes made on the Patient identification screen will be registered in audit trail
the audit trail function. The audit trail contains information about the operator who made the change, time of change
and new/old values (changes made at the same time are indicated with "–" in the Time and User columns).
Messages on the screen is substituted with Log to indicate that changes were made.
Step Action
Press Log on the Patient result screen to display the following
1.
buttons: Audit trail and Messages.
2. Press Audit trail.
3. Use the up/down arrows to scroll the list of changes.
4. Press Back to return to the Patient result screen.
ABL90 FLEX operator's manual 4. Sample measurement

Patient result messages

Screen
Press Messages on the Patient result messages screen. messages
The Patient result messages screen gives the erroneous parameter(s) and the message(s) with number(s).
Messages can be seen on the following three levels:
User Messages for the user familiar with the basic daily operation
of the analyzer and primarily responsible for performing measurements. This level displays the fewest messages.
Manager Messages for the user with a deeper knowledge of the
analyzer functions and responsible for the analyzer's proper operation.
Service Messages for the service technician with a thorough
knowledge of the operation and construction of the analyzer. This level displays the greatest number of messages
and in most detail.
The following buttons are available:
Result Press to return to the Patient result screen.
Troubleshoot Press to display the error description, operator actions and in
some cases also a removal condition – see chapter 11: Troubleshooting in this manual and also chapter 10: Analyzer
messages in the ABL90 FLEX reference manual for detailed information.
Print Press to print out the screen message(s).
Back Press to return to the previous screen.
Note Press to display the keyboard, type the note and confirm
with Enter.
If notes for patient result were entered in the User-defined notes program (see chapter 1: Setup in the ABL90 FLEX
reference manual), select a note from the list with the up/down arrows.
To edit a note, press Edit note and type the note on the keyboard.
Remember to confirm it with Enter on the keyboard.
To delete a note, press Delete note.
4-19
4. Sample measurement ABL90 FLEX operator's manual
4-20

5. Quality management

Automatic quality management system ...................................................... 5-2

General information................................................................................. 5-3

Built-in quality control ............................................................................. 5-4

System checks ....................................................................................... 5-6

Analysis check........................................................................................ 5-7

Manual quality control.............................................................................. 5-8

Manual quality control.............................................................................. 5-8

Additional quality control.........................................................................5-12

 5-1
5. Quality management ABL90 FLEX operator's manual

Automatic quality management system

5-2

With the ABL90 FLEX quality management system, all necessary checks are done automatically and continuously by
the analyzer.
If the result of the check is not acceptable, the analyzer automatically performs a corrective action, unless a user
intervention is required.
Checks and corrective actions are logged in the activity log of the analyzer and can be obtained if documentation is
needed.
The quality management system is based on the following checks:
• Built-in QC
• System checks
• Analysis check (performed before, under and after each activity)
Quality management is performed on six different solutions that are all built into the solution pack. Three solutions
(CAL1, CAL2, CAL3) are used for calibration, analysis check and system check, and three solutions (QC1 (S9030),
QC2 (S9040), and QC3 (S9050)) are used for quality controls.
ABL90 FLEX operator's manual 5. Quality management

General information
Purpose
The purpose of quality control is to evaluate the performance of the analyzer to ensure the reliability, accuracy, and
precision of patient sample results.
Quality controls are run automatically on the built-in solutions in the solution pack.
Furthermore, the ABL90 FLEX analyzer automatically performs periodic system checks and continuous analysis
checks to provide further confidence in the fact that the analyzer is performing according to specifications (see
descriptions later in this chapter).
Built-in QC measurements are by default performed every 8 hours. Additional Quality controls should be run after all
troubleshooting or preventive maintenance procedures that may alter the performance of the analyzer or whenever a
service technician has doubts about the performance of the analyzer. It is also possible to run manual QC with glass
ampoules and to start an unscheduled built-in QC measurement (see later in this chapter).
QC should be performed according to:
• internal quality assessment procedures
• local, state or federal regulation
Glossary list
The following terms are used in the quality management:
Term Explanation
Accepted result A measurement value which falls within the statistics range.
Assigned value/
The assigned value is the center value of the control range. target value
Control range The range within which a measurement should fall. Typically
the control range is set to be the mean ± 2 SD (see section Quality control setup in chapter 1: Setup in the ABL90
FLEX reference manual). This range can be set by using the lot- to-date range (2 SD) calculated by the analyzer, or it
may be user-defined.
Insert range The upper and lower control ranges are established by
Radiometer. On built-in QC they are given automatically when the solution pack is installed. On manual QC with
glass ampoules they are found on the insert provided with each box of control solutions.
Lot-to-date range A range calculated by the analyzer from measurements
taken on a lot of a particular control solution. It is represented by mean ± 2 SD.
Range of indication
5-3 The range for each parameter that the analyzer physically is capable of measuring. Refer to Measured
parameters, chapter 13: Specifications for the analyzer range of indication for each parameter.
Statistics factor The factor by which the control range is expanded
(multiplied by) to determine the statistics range. The recommended statistics factor is 1.5.
Statistics range The range within which a measurement must fall in order to
be included in the quality control statistics. It is determined by multiplying the control range limits by the entered
statistics factor. It is typical that the statistics range is set to the mean ± 3 SD.
5. Quality management ABL90 FLEX operator's manual
5-4
For detailed information on terminology and principles for the quality control systems, see I Appendix - Quality control
in the ABL90 FLEX reference manual.
Built-in quality control
Schedule
Built-in QC measurements are by default performed every 8 hours (one on each level). The interval of these events
can be defined by the user in the Quality control schedule setup program – see section Quality control setup in
chapter 1: Setup in the ABL90 FLEX reference manual.
Built-in QC results are assigned to the slots A, B and C.
Acceptable
The assigned value and acceptance range for each parameter are entered ranges
automatically into the analyzer each time a new solution pack is installed.
Built-in QC
A scheduled QC measurement will start on time, provided that no calibrations measurement
are pending. A pending calibration will be performed before the scheduled QC measurement.
View built-in
Press Result: QC results
• on the Quality control identification screen
• from Menu > Analyzer status > Quality control
• from the Quality control log
The measured values are compared with the defined control range, statistics range and range of indication, and then
given a status mark accordingly.
NOTICE: The user-defined corrections (slope and offset) do not influence the quality control results, unless the
"Apply parameter corrections to QC" function has been activated in Miscellaneous setup – see chapter 1: Setup in
the ABL90 FLEX reference manual.
ABL90 FLEX operator's manual 5. Quality management
Parameter
The absence of any markings next to a parameter indicates that a parameter status
was measured without fault.
Marking Explanation
? Error in the previous calibration, or analyzer malfunction.
W A violated Westgard rule.
R A violated RiLiBÄK rule.
Parameter value is outside the control range, but inside the statistics range.
Only the values within the statistics range are considered accepted and are included in the QC statistics.
Parameter value is outside the statistics range and is not included in the statistics.
Parameter value is outside the range of indication. Measurement is not included in the statistics.
* Parameter values with user-defined corrections – see
Parameter setup in section Parameters and input setup in chapter 1: Setup in the ABL90 FLEX reference manual for
details.
..... Parameter value could not be calculated, most likely due to a
system error or malfunction. These values will for the most part be accompanied by a "?". To obtain a possible
explanation, press Message.
To evaluate the analyzer quality control status at a glance, enter the Analyzer status screen. Fur further information
about the analyzer quality control status see section Quality control (QC) in chapter 3: Analyzer status.
Unscheduled
To start an unscheduled built-in QC measurement, do the following: built-in QC measurement
Step Action
1. Press Menu > Analyzer Status > Quality Control.
2. Highlight the built-in QC solution to run an unscheduled
measurement on.
 3. Press Start QC to start the measurement.
The Quality control result is shown after the measurement is completed.
Reference
If the built-in QC results are outside the acceptable control ranges, follow the instructions on the Troubleshooting
screen (the instructions are also given in Chapter 10: Analyzer messages in the ABL90 FLEX reference manual).
5-5
5. Quality management ABL90 FLEX operator's manual

System checks

Description System checks are performed regularly and autom

zer performs system checks to verify that the individual components maximized and long-termed activities and frequent
ioning properly and according to specifications. for the user to make any additional checks if this is

If the system checks fail, they are in most cases retried, and, if possible, remedied automatically
by the analyzer. If these system checks fail again, the analyzer enters the user-intervention-
required mode. This means that if any interventions are required by the user, the User-
intervention-required screen appears with instructions on what to do to in the particular case.

The system checks consist of the following checks:

• Computer checks

• Software checks

• Mechanical checks

• Electronical checks

• Temperature checks

• Consumable integrity checks on time of installation

The system checks are performed at different times and with different intervals, depending on
the checks that are to be performed. Some checks are performed once a day, some with every
rinse, and others every 10 seconds.

For further information on the individual checks please refer to section Quality management in chapter 5: Sensors
and measuring technologies in the ABL90 FLEX reference manual.
 5-6
ABL90 FLEX operator's manual 5. Quality management

Analysis check

Description If the analysis checks fail, they are in most cases re

patient sample analysis, a calibration or a QC measurement – the automatically by the analyzer. If these analysis che
ent checks automatically to verify that the analyzer is functioning intervention-required screen. This means that if a
nd after measuring activities. by the user, the User-intervention- required scree
in the particular case.

The analysis checks consist of the following checks:

• Status calibrations/checks

• Sample integrity checks

• Temperature checks

• Mechanical checks

• Electronical checks

• Measurement preparation checks

• Consumable checks

The analysis checks are performed every second hour according to the default scheduled
analysis activities (calibrations and QC measurements) and in connection with patient sample
measurements.

For further information on the individual checks please refer to section Quality management in chapter 5: Sensors
and measuring technologies in the ABL90 FLEX reference manual.
 5-7
5. Quality management ABL90 FLEX operator's manual

Manual quality control

As an alternative to built-in quality controls, you may analyze manual QC samples, if

desired.

It is recommended to use QC material from Radiometer (the QUALICHECK5+ control system)

to ensure an optimal performance of the analyzer and to take advantage of features such as
temperature correction and automatic QC level detection. See I Appendix - Quality control in the
ABL90 FLEX reference manual.

It is possible to use non-Radiometer solutions although the accuracy and validity of the results
cannot be guaranteed.

To assign a quality control solution to a specific slot or to change the quality control solution of
a slot see Manual quality control (QC) solutions in section Quality control setup in chapter 1:
Setup in the ABL90 FLEX reference manual.

Required 5-8
materials CAUTION – Changing a control solution

Before
QC system Materials required
measurement on a
control solution QUALICHECK5+ • Four levels of QC solutions (S7730, S7740, S7750,
ust be conditioned before measurement. Store the ampoules for 5 hours at a constant temperature between 18-32 °C.
Changing a control solution assigned to a slot will delete all current quality control
statistics obtained on that slot. If you want a copy of the statistics for the last QC
month, create a WDC Report – see chapter 2: Disk Functions setup programs in the
ABL90 FLEX reference manual.

To schedule a QC measurement, see Quality control schedule setup in section Quality control
setup in chapter 1: Setup in the ABL90 FLEX reference manual.

S7760)

• QUALICHECK adapter

• Rubber gloves

• Ampoule opener

Control solutions are sensitive to light, so always keep the ampoule box closed.

2. Hold the ampoule between two fingers as shown

and shake it vigorously for at least 15 seconds.

3. Tap the top of the ampoule until all of the solution collects at the
bottom.

4. Place the ampoule in the ampoule opener and 2

1
break off the ampoule neck.
ABL90 FLEX operator's manual 5. Quality management
5. Place the ampoule fully into the QUALICHECK
adapter.
6. Open-ampoule stability: To ensure the reliability of the
measurement, each QC ampoule must be used immediately after opening, for one measurement on one analyzer.
Introducing a
Step Action QC solution
1. Check that the analyzer is in the Ready mode.
2. Lift the inlet to the syringe position.
3. Select Ampoule - QC.
4. Place the adapter tip against the
inlet gasket and press it upwards. The probe extends into the ampoule and the QC solution is automatically
aspirated.
NOTICE: Be careful not to bend the probe.
Hold on to the adapter when removing the QC solution.
5. When prompted by the analyzer, remove the adapter and close the
inlet.
6. Dispose of used ampoules as infectious waste*.
* Clinical laboratory waste management. CLSI document GP5-A2.
Entering
Step Action information with barcode reader
1. Activate the "Enable general barcode support" check button in
Miscellaneous setup, if not already done (Menu > Utilities > Setup > General setup > Miscellaneous setup).
2. Highlight the "Operator" field and scan "Operator" from your ID card (see Barcode reader in section Hardware in
chapter 2: What is what).
If the name is included in the list of the analyzer's registered users, the barcode automatically will identify the person
and fill in the name.
5-9
5. Quality management ABL90 FLEX operator's manual
5-10 Entering
Step Action information manually
1. Highlight the item to be edited, using the up/down arrows.
• The solution is entered automatically. Choose the specific slot from the screen.
• Lot is entered automatically if only one lot for each solution is used. Otherwise highlight the desired item on the
screen and confirm with the Enter button.
2. Enter the ambient temperature (default: 25 °C) on the keypad and
confirm with the Enter button.
Mandatory entry is indicated by a .
3. Enter "Department" on the keypad and confirm with the Enter
button.
4. Enter "Operator" on the keypad or keyboard and confirm with the Enter button (filled in automatically when
operator is logged on).
The measured values are compared with the defined control range, statistics range and range of indication, and then
given a status mark accordingly.
NOTICE: The user-defined corrections (slope and offset) do not influence the quality control results, unless the
"Apply parameter corrections to QC" function has been activated in Miscellaneous setup (see section Miscellaneous
setup in chapter 1: Setup in the ABL90 FLEX reference manual).
View manual
In most cases the Quality control result screen will be displayed automatically QC results
when the measurement has been completed. However, if the QC identification took longer time to enter than the
measurement, you can press Result:
• on the Quality control identification screen
• from Menu > Analyzer status > Quality control
• from the Quality control log.
Parameter
The absence of any markings next to a parameter indicates that a parameter status
was measured without fault.
For an explanation of possible parameter markings, please refer to Parameter status in section Built-in quality control
earlier in this chapter.
ABL90 FLEX operator's manual 5. Quality management
Unknown
Quality control on a solution, identified as unknown, are not compared with any solutions
previous measurements or statistics, and, therefore, do not receive any status marking. The parameter results for
unknown levels cannot be plotted and are not included in any statistical data unless later changed to a defined slot.
Temperature
For QC solutions from Radiometer, temperature corrections are made corrections
automatically with the typed-in temperature.
For non-Radiometer QC solutions, temperature corrections must be made manually. Refer to the manufacturer's
literature for procedure.
Reference
For a detailed explanation of the evaluation of results, refer to I Appendix - Quality control in the ABL90 FLEX
reference manual. If the results are outside the acceptable control ranges, please refer to Chapter 10: Analyzer
messages in the ABL90 FLEX reference manual or follow the instructions on the Troubleshooting screen.
Recalling
To change data that can be edited (non-gray lettered) on the screen, press QC quality control ID. identification

NOTICES: • If leaving the Quality control identification screen without

entering a temperature, the previous temperature will be recalled
• Changing the temperature will initiate recalculation of the last result. It will be substituted by the recalculated result,
and the statistics will also be recalculated. In case the temperature is mandatory, the result cannot be viewed until it
is entered.
5-11