RADIOMETER ABL800 FLEX Operator's Manual

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ABL800 FLEX operator’s manual

ABL800 FLEX

operator’s

manual

Introduction

Instructions to user

Note to users of the ABL800 FLEX analyzers

This note to users gathers changes from previous note to users in one document and outlines some new changes to the operator’s manual of your ABL800 FLEX analyzer (from software version 6.10).

Please remove the existing note to users from the binder of your manual and place this note to users in the binder instead.

Brief overview of the change

Interference – new interference results for ClO

USB connector

Changes/Description

Limitations of use and known interfering substances:

–

CAUTION - Known interfering substances

Substance Interference

ClO

–

(drugs)

For ClO level), cCl mmol/L level)

cCa cCl cK

– ,

interference on cCa2+ (1.25 mmol/L



(110 mmol/L level), and cK+ (4

has been detected:

(1.25 mmol/L level): 0.27*



(110 mmol/L level): 4-30

(4 mmol/L level): 0.3.

* Depending on the pH level

Instead of the CD-ROM drive, a USB connector may be available.

USB connector or CD-ROM drive

The USB connector can be used for storing data on an USB flash drive (memory stick) or for connecting USB devices. Can also be used for installation of software.

Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, PICO and CLINITUBES are trademarks of Radiometer Medical ApS.

Measured

New table for pleural liquid:

parameters

Parameter Unit Measuring

Range

Test

range

pH pH scale 6.300-8.000 7.0-7.5*

* If the measured values obtained lie outside the test range, Radiometer advises you to repeat the measurement by means of another method.

Indoor use statement added according to CSA regulations: Environmental

requirements

Environmental ratings

Clot detection A new feature is included in software version 6.06 of the following

Location Indoor use only Pollution degree 2 statement added according to CSA regulations:

Installation category II. Pollution degree 2.

products:

 ABL7xx Series (XPE) analyzers  ABL800 FLEX analyzers  ABL800 BASIC analyzer.

The new feature enables the analyzer to detect clots caught in the measurement chamber under the pH electrode. This document describes it.

When to activate the clot-detection feature

It is especially beneficial to activate the clot detection feature in analyzers frequently used to analyze samples known to be prone to clotting, for example, samples drawn from umbilical cords. Once activated clot detection is active during all sample measurements.

NOTICE: It is important to note that activating the feature will delay measurement results by approximately one minute, even though it only increases the measurement cycle time by five seconds. It also increases consumption of Rinse solution, but this is minimal.

To activate the clot-detection feature

Contact a Radiometer representative and request that clot detection be enabled via the service program.

Clot-detection process

During calibration the measuring chamber is rinsed and the pH of the Rinse solution is measured. The value is stored in the analyzer.

During a sample measurement the measuring chamber is also rinsed and the pH of the rinse solution is measured and compared with the pH value stored during the last calibration. If the difference between these values (the pH drift) exceeds a pre-determined maximum value, it could indicate the presence of a clot beneath the pH electrode.

When enabled, the clot-detection feature can generate three new messages that are listed below.

Analyzer messages NOTICE: Operator actions are listed in order of priority. Perform

the first action in the list and the actions indicated in the "Removal condition(s) list. If the message persists, perform the next listed action and the actions indicated in the "Removal condition(s) list, and so on.

No. Message Interpretation Operator action(s)

1025

Clot suspected beneath pH electrode*

The difference between the pH of the rinse solution, measured during the sample measurement, and that stored after the last calibration exceeds the

Remove the pH electrode and

check the measuring chamber for clots: clean the measuring chamber with a cotton stick moistened with distilled water. Make sure no cotton fibers are left in the measuring chamber

Clean pH electrode

maximum al l owable drift.

This indicates the presence of a clot in the measuring chamber beneath the pH electrode.

Remembrane Ref electrode Replace pH electrode

Perform a 1- or 2-point calibration

Removal condition(s):

 Acknowledge execution of the

"Clot removal procedure"

 Successful 1- or 2-point

calibration

* NOTICE: This is a system message.

1026 Clot (pH)

detection not possible

The pH of the rinse solution - stored during the latest calibration - was invalidated when either the Rinse solution was replaced, or when maintenance was performed on an electrode.

A new pH value needs to be established by performing a calibration.

 Perform a 1- or 2-point

calibration.

Removal condition(s):

 Successful 1- or 2-point

calibration.

1027 Clot suspected

beneath pH electrode

Acknowledging execution of a "Clot-removal procedure"

The difference between the pH of the rinse solution, measured during the sample measurement, and that stored after the last calibration exceeds the maximum al l owable drift.

This indicates the presence of a clot in the measuring chamber beneath the pH electrode.

Step Action

Press Analyzer status > Electrodes and others.

Press Replace.

 Remove the pH electrode and

check the measuring chamber for clots: clean the measuring chamber with a cotton stick moistened with distilled water. Make sure no cotton fibers are left in the measuring chamber

 Clean pH electrode  Remembrane Ref electrode  Replace pH electrode

Perform a 1- or 2-point calibration

Removal condition(s):

 Acknowledge execution of the

"Clot removal procedure"

 Successful 1- or 2-point

calibration

Technical documentation

Press Clots removed.

Data in this document will be added to the manual next time it is updated.

Radiometer Medical ApS Åkandevej 21 2700 Brønshøj Denmark www.radiometer.com

Table of contents

ABL800 FLEX

Operator’s manual

1. Introduction

2. What is what

3. Installation and setup

4. Sample measurements

5. Quality control

6. Calibration

7. Replacements

8. Disk functions

9. Data management

10. Analyzer shutdown

11. Troubleshooting

12. Sampling

13. Specifications

14. Ordering information

15. Radiometer settings

Index - Date of issue

System performance

The procedures described in this manual must be observed in order to ensure proper system performance, and to avoid hazards.

Radiometer cannot provide or verify system performance characteristics if the system is not installed, used and maintained in accordance with Radiometer procedures or if accessories not meeting the specifications provided by Radiometer are used.

Radiometer warrants that the data media on which the software included in the system is furnished is free from defects in material and workmanship under normal use for three (3) months from the date of delivery as evidenced by a copy of invoice or receipt.

Third-party software and trademarks

The ABL800 FLEX analyzers comprise the Microsoft WindowsXP Embedded, VxWorks and Sybase SQL Anywhere software.

By using the system, you accept the terms of the Software License Agreement(s) of the provider(s) of the above software as shown in the End User License Agreement(s) in the analyzer start up picture and to the terms of the Microsoft WindowsXP Embedded End-User Agreement included in this manual. If you cannot accept the terms of the Software License Agreement(s), you should not use the system, but immediately contact your provider for a return of the system and a refund of the purchase price.

Microsoft® and Windows® are trademarks of Microsoft Corporation. VxWorks is a registered trademark of WindRiver Systems Incorporated. Sybase SQL Anywhere is a registered trademark of Sybase Incorporated.

Warranties and disclaimer

Radiometer makes no warranties, express or implied, other than expressly stated. Any warranties expressly stated in this document are conditional upon the system being installed, used

and maintained in accordance with Radiometer procedures, incl uding that only accessories meeting the specifications provided by Radiometer are used.

Radiometer disclaims any liability for system performance if the system is not installed, used and maintained in accordance with Radiometer procedures or if accessories not meeting the specifications provided by Radiometer are used.

Further, Radiometer disclaims any liability for loss of data and direct, consequential or other damages, including loss of profit or loss of business, whether such claim for damages is based upon contract, negligence or tort (including strict liability), and even if Radiometer has knowledge of the possibility of the potential damage or loss.

Confidentiality

The contents of this document shall not be reproduced or communicated to any third party without the prior written consent of Radiometer.

Changes

This document is subject to change without notice and you are urged to contact Radiometer to verify whether the document has been changed.

While every effort is made to ensure the correctness of the information provided in this document as changed from time to time, Radiometer disclaims any liability for errors and omissions.

Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, PICO and CLINITUBES are trademarks of Radiometer Medical ApS.

TEnd-User License Agreement for the ABL800 FLEX Analyzers

You have acquired a device ("DEVICE") THAT INCLUDES SOFTWARE LICENSED BY Radiometer Medical ApS from Microsoft Licensing Inc. or its affiliates ("MS"). Those installed software products of MS origin, as well as associated media, printed materials and "online" or electronic documentation ("SOFTWARE") are protected by international intellectual property laws and treaties. The SOFTWARE is licensed, not sold. All rights reserved.

IF YOU DO NOT AGREE TO THIS END-USER LICENSE AGREEMENT ("EULA"), DO NOT USE THE DEVICE OR COPY THE SOFTWARE . INSTEAD, PROMPTLY CONTACT THE SUPPLIER OF THE INSTRUMENT FOR INSTRUCTIONS ON RETURN OF THE UNUSED DEVICE(S) FOR A REFUND. ANY USE OF THE SOFTWARE, INCLUDING BUT NOT LIMITED TO USE ON THE

DEVICE WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA (OR RATIFICATION OF ANY PREVIOUS CONSENT).

GRANT ON SOFTWARE LICENSE. This EULA grants you the following license:

• You may use the SOFTWARE only on the DEVICE.

• NOT FAULT TOLERANT. THE SOFTWARE IS NOT FAULT TOLERANT. RADIOMETER

MEDICAL ApS HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE, AND MS HAS RELIED UPON RADIOMETER MEDICAL ApS TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR SUCH USE.

• NO WARRANTIES FOR THE SOFTWARE. THE SOFTWARE is provided "AS IS" and with all

faults. THE ENTIRE RISK AS TO SATISFACTORY QUALITY, PERFORMANCE, ACCURACY, AND EFFORT (INCLUDING LACK OF NEGLIGENCE) IS WITH YOU. ALSO, THERE IS NO WARRANTY AGAINST INTERFERENCE WITH YOUR ENJOYMENT OF THE SOFTWARE OR AGAINST INFRINGEMENT. IF YOU HAVE RECEIVED ANY WARRANTIES REGARDING THE

DEVICE OR THE SOFTWARE, THOSE WARRANTIES DO NOT ORGINATE FROM, AND ARE NOT BINDING ON, MS.

• Note on Java Support. The SOFTWARE may contain support for programs written in Java. Java technology is not fault tolerant and is not designed, manufactured or intended for use or resale as online control equipment in hazardous environments requiring fail-safe performance, such as in the operation of nuclear facilities, aircraft, navigation or communication systems, air traffic control, direct life support machines or weapons systems, in which the failure of Java could lead directly to death, personal injury, or severe physical or enviromental damage. Sun Microsystems, Inc. has contractually obligated MS to make this disclaimer.

• No Liability for Certain Damages. EXCEPT AS PROHIBITED BY LAW, MS SHALL HAVE NO LIABILITY FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE SOFTWARE. THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE. IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN EXCESS OF US. TWO HUNDRED FIFTY DOLLARS (US$250.00).

• Limitations on Reverse Engineering, Decompilation and Disassembly. You may not reverse engineering, decompile, or disassemble the SOFTWARE, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation.

• SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS. You may permanently transfer rights under this EULA only as a part of a permanent sale or transfer of the DEVICE, and only if the recipient agrees to this EULA. If the SOFTWARE is an upgrade, any transfer must also include all prior versions of the SOFTWARE.

• EXPORT RESTRICTIONS. You acknowledge that SOFTWARE is of US-origin. You agree to comply with all applicable international and national laws that apply to the SOFTWARE, including the US Export Administration Regulations, as well as end-user, end-use and country destination restrictions issued by US and other governments. For additional information on exporting the SOFTWARE, see

http://www.microsoft.com/exporting/.

Contents

This manual contains the following topics.

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

Overview........................................................................................................... 1-1

Names and intended use.................................................................................... 1-2

Limitations of use and known interfering substances....................................... 1-4

Warning/Caution and Notices........................................................................... 1-7

Symbols overview............................................................................................. 1-8

2. What is what ..................................................................................................... 2-1

Overview........................................................................................................... 2-1

Analyzer - front................................................................................................. 2-2

Analyzer - rear .................................................................................................. 2-4

Measuring section.............................................................................................2-5

Inlet module......................................................................................................2-7

FLEXQ module................................................................................................. 2-8

Thermal printer ............................................................................................... 2-10

Communication ports...................................................................................... 2-11

Barcode reader................................................................................................ 2-13

AutoCheck module ......................................................................................... 2-14

Screen elements .............................................................................................. 2-15

Menu structure................................................................................................ 2-24

Analyzer status................................................................................................ 2-28

Online aid facilities......................................................................................... 2-36

Sample counter................................................................................................ 2-39

3. Installation and setup....................................................................................... 3-1

Overview........................................................................................................... 3-1

Installation ........................................................................................................ 3-2

Setup menu structure......................................................................................... 3-3

Analyzer security.............................................................................................. 3-6

Analysis setup................................................................................................. 3-13

Patient reports ................................................................................................. 3-26

Calibration setup............................................................................................. 3-32

Quality control setup....................................................................................... 3-35

Replacement setup.......................................................................................... 3-48

Contents ABL800 FLEX Operator's Manual

Parameters and input setup ............................................................................. 3-55

Analyzer settings............................................................................................. 3-62

Communications............................................................................................. 3-68

Printers............................................................................................................ 3-77

Disk Functions setup....................................................................................... 3-80

Corrective actions ........................................................................................... 3-83

Miscellaneous setup........................................................................................ 3-86

4. Sample measurements...................................................................................... 4-1

Overview........................................................................................................... 4-1

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

Immediately before analysis ............................................................................. 4-9

Measurements with FLEXQ ........................................................................... 4-10

Introducing a blood sample............................................................................. 4-12

Introducing a pleura sample............................................................................ 4-15

Introducing an expired air sample................................................................... 4-16

Patient identification....................................................................................... 4-17

Patient result ................................................................................................... 4-21

Calculation of FShunt and ctO2(a -

) ........................................................... 4-25

Patient result messages.................................................................................... 4-26

5. Quality control.................................................................................................. 5-1

Overview........................................................................................................... 5-1

General information.......................................................................................... 5-2

Preparing a control solution.............................................................................. 5-4

Manual quality control measurement................................................................ 5-6

AutoCheck measurement.................................................................................. 5-7

Quality control identification............................................................................ 5-8

Quality control result ...................................................................................... 5-10

Quality control result messages ...................................................................... 5-15

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

Overview........................................................................................................... 6-1

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

Unscheduled calibrations.................................................................................. 6-4

Interrupted, pending or expired calibrations..................................................... 6-5

tHb calibration .................................................................................................. 6-6

Calibration result............................................................................................... 6-8

Calibration result messages............................................................................. 6-10

ABL800 FLEX Operator's Manual Contents

7. Replacements .................................................................................................... 7-1

Overview........................................................................................................... 7-1

General information.......................................................................................... 7-2

Replacing membranes or electrodes.................................................................. 7-6

Replacing pump tubes....................................................................................... 7-9

Replacing inlet gasket unit and inlet probe..................................................... 7-12

Replacing waste container, fan filter, printer paper........................................ 7-14

Replacing solutions and gases ........................................................................ 7-16

Refilling the AutoCheck carousel................................................................... 7-19

Automatic auxiliary programs ........................................................................ 7-20

Decontamination and Protein Removal programs.......................................... 7-21

Cleaning the analyzer...................................................................................... 7-23

List of references............................................................................................. 7-25

8. Disk Functions .................................................................................................. 8-1

Overview........................................................................................................... 8-1

General information.......................................................................................... 8-2

Creating a WDC report..................................................................................... 8-4

Backing up all data............................................................................................ 8-6

Restoring all data .............................................................................................. 8-8

Exporting data logs........................................................................................... 8-9

Importing/exporting archives.......................................................................... 8-11

Saving setup.................................................................................................... 8-13

Loading/restoring setup .................................................................................. 8-14

9. Data management............................................................................................. 9-1

Overview........................................................................................................... 9-1

General information.......................................................................................... 9-2

Patient Results Log........................................................................................... 9-4

Patient Profiles Log........................................................................................... 9-7

Quality Control Log........................................................................................ 9-11

Calibration Log............................................................................................... 9-17

Activity Log.................................................................................................... 9-20

Replacement Log............................................................................................ 9-23

Archived data logs .......................................................................................... 9-24

RADIANCE browser (optional) ..................................................................... 9-26

10. Analyzer shutdown......................................................................................... 10-1

Overview......................................................................................................... 10-1

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

Contents ABL800 FLEX Operator's Manual

Standby mode ................................................................................................. 10-3

Full waste container........................................................................................ 10-5

Temporary Shutdown...................................................................................... 10-6

Long Term Shutdown..................................................................................... 10-8

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

Overview......................................................................................................... 11-1

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

Forced Hold causes......................................................................................... 11-5

Analyzer messages.......................................................................................... 11-7

Fluid transport troubleshooting procedure.................................................... 11-74

Inlet probe troubleshooting procedure.......................................................... 11-75

Inlet troubleshooting procedure.................................................................... 11-76

Leak troubleshooting procedure ................................................................... 11-77

Electrode troubleshooting procedures........................................................... 11-78

Pump troubleshooting procedure.................................................................. 11-80

Fluid transport system description................................................................ 11-81

12. Sampling.......................................................................................................... 12-1

Overview......................................................................................................... 12-1

Causes of errors in preanalytical phase........................................................... 12-2

Preparation prior to arterial/venous sampling................................................. 12-5

Preparation prior to capillary sampling........................................................... 12-7

Sampling devices............................................................................................ 12-8

Storage and preparation prior to analysis........................................................ 12-9

Sampling procedures..................................................................................... 12-12

References..................................................................................................... 12-15

13. Specifications .................................................................................................. 13-1

Overview......................................................................................................... 13-1

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

Input parameters.............................................................................................. 13-5

Derived parameters......................................................................................... 13-6

Sample handling.............................................................................................. 13-8

Calibration and maintenance programs......................................................... 13-11

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

Analyzer specifications................................................................................. 13-14

Approvals and patents................................................................................... 13-16

ABL800 FLEX Operator's Manual Contents

14. Ordering information..................................................................................... 14-1

Overview......................................................................................................... 14-1

Analyzer accessories....................................................................................... 14-2

Quality control................................................................................................ 14-5

Sampling devices............................................................................................ 14-7

15. Radiometer settings........................................................................................ 15-1

Overview......................................................................................................... 15-1

Radiometer default settings............................................................................. 15-2

Contents of setup settings ............................................................................. 15-15

Calibration verification................................................................................. 15-18

Interfacing facilities...................................................................................... 15-20

Index Date of issue

Contents ABL800 FLEX Operator's Manual

Overview

Introduction

Contents

1. Introduction

The chapter briefly describes the intended use of the analyzer, lists all measured parameters and the substances known to interfere with the measurements, and explains the different notices that appear in the manual.

Throughout this manual, "ABL800 FLEX analyzer" is used for all ABL8xx FLEX analyzers, i.e.: ABL837/835/830/827/825/820/817/815/810/805 and ABL810 BG only.

The abbreviation "ABL8x7 FLEX analyzer" is used for the ABL837/27/17 FLEX analyzers throughout this manual.

This chapter contains the following topics.

Names and intended use................................................................................... 1-2

Limitations of use and known interfering substances...................................... 1-4

Warning/Caution and Notices.......................................................................... 1-7

Symbols overview........................................................................................... 1-8

1. Introduction ABL800 FLEX Operator's Manual

Names and intended use

Names

Intended use

Proprietary name: ABL800 FLEX blood gas, oximetry, electrolyte and

metabolite analyzer.

Common name: Blood gas, oximetry, electrolyte and metabolite measuring

system.

The ABL800 FLEX analyzers are intended for:

• In Vitro testing of samples of whole blood for the parameters pH, pO

, cNa+, cCa2+, cCl–, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters

(ctHb, sO

, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and

FHbF)

• in vitro testing of samples of expired air for the parameters pO

and pCO2

• in vitro testing of pleura samples for the pH parameter. The following parameters can be measured on blood:

Parameter group Parameters

pH/blood gas:

Oximetry:

pH (acidity) pCO2 (carbon dioxide tension)

(oxygen tension)

ctHb (total hemoglobin concentration) sO2 (oxygen saturation) FO2Hb (fraction of oxyhemoglobin in total hemoglobin) FCOHb (fraction of carboxyhemoglobin in total hemoglobin) FHHb (fraction of deoxyhemoglobin in total hemoglobin) FMetHb (fraction of methemoglobin in total hemoglobin) FHbF (fraction of fetal hemoglobin)

, pCO2,

1-2

Electrolytes:

Metabolites:

cK+ (potassium ion concentration) cNa+ (sodium ion concentration)

cCa

(calcium ion concentration)

–

(chloride ion concentration)

cCl cGlu (D-glucose concentration) cLac (L(+)-lactate concentration) ctBil (concentration of total bilirubin, measurement in plasma

is possible, see Limitations of use later in this chapter) cCrea (concentration of creatinine, measurement on plasma

and serum possible, see Limitations of use later in this chapter)

Continued on next page

ABL800 FLEX Operator's Manual 1. Introduction

Names and intended use, Continued

Intended use (continued)

The following parameters can be measured on pleura samples:

Parameter group Parameters

Measured value pH (acidity)

The following parameters can be measured on expired air samples:

Parameter group Parameters

Measured values pCO2 (carbon dioxide tension)

(oxygen tension)

Derived parameters are listed in chapter 13: Specifications and described in detail in the Reference Manual, chapter 6.

Requirement to the operator

Measurements on animal blood

FLEXMODE

Measurements on pleural fluids

Other fluids mode

FLEXQ module

NOTICE:

The analyzer should be used by personnel who have received special education and training with regard to procedures utilizing in vitro diagnostic medical devices.

Animal blood has not been tested on the ABL800 FLEX analyzer. Some components in animal blood differ from those in human blood, and variations in the composition of blood from different animal species may also exist.

This mode allows you to analyze a blood sample of 35 μL and higher – up to the maximum volume accepted by your analyzer. Depending on the available sample volume, the FLEXMODE provides the highest number of parameters: from all available to as many as reliably possible.

This mode is not available in the ABL8x7 FLEX analyzers.

Pleura pH can be measured on pleural fluids. Corrections are present in the device.

All parameters available on your ABL800 FLEX analyzers can be measured on fluids other than heparinized human whole blood

NOTICE: Before using this mode you must establish "user-defined corrections" for each parameter used, on the fluid in question. The corrections assume a linear correlation between the measured value and the reference instrument. The data used for establishing "user-defined corrections" have to cover the desired measuring range. If no user-defined corrections are entered, you will measure in this mode as if on heparinized human whole blood.

The FLEXQ module can accommodate up to three samplers simultaneously. It reads a sampler's barcode, mixes the sample and transports the sampler to the inlet for aspiration and analysis without any further assistance from the operator. Results can be delivered via FLEXLINK (for information refer to the RADIANCE Installation and Setup Manual).

The model ABL810 can also be ordered without oximetry parameters: as ABL810 BG only.

1-3

1. Introduction ABL800 FLEX Operator's Manual

Limitations of use and known interfering substances

Limitations of use

The following limitations should be taken into consideration: The ABL800 FLEX analyzers are designed for measurements of adult and fetal

hemoglobin with normal spectrum characteristics. Some spectra deviate from the normal characteristics, e.g. for certain hemoglobinopathies and the ABL800 FLEX analyzers do not compensate for this.

CAUTION - Fulfillment of user-specific analytical needs

The user should review the analyzer performance data to assure that the performance fulfills the user-specific analytical needs.

WARNING – Clinical decisions

The validity of the test results from this instrument must be carefully examined by a clinician and related to the patient’s clinical condition, before any clinical decisions are taken on the basis of the test results.

CAUTION Known interfering substances

CAUTION - Risk of erroneous results

Always meticulously follow the sampling procedures described in chapter 12: Sampling. Failure to follow these procedures may introduce clots or air

bubbles in the sample and yield erroneous results.

NOTICE: Bilirubin measurements on plasma and creatinine measurements on plasma and serum need to be measured in Other fluids mode, as the other modes are intended for measurement on human whole blood only. Corrections for Creatinine can be found in the Reference Manual.

FHbF measurement: The uncertainty in FHbF measurements exceeds the level required to measure normal HbF levels in the adult range (FHbF reference range is 0-1 %).

The following substances are known to affect or interfere with measurements on the ABL800 FLEX analyzers.

Substance Interference

Halothane (anesthetic) May give unreliable pO2 results. Lipid therapy (treatment) In OXI measurements.

After measurement on blood from a patient who has received lipid therapy it may be necessary to clean the analyzer using the Cleaning program.

Methylene Blue, HiCN

In OXI measurements.

(medication) Anions: B

−

−S2−

,I , and Cl

−

Erroneously high

cCl

results.

(drugs)

Continued on next page

1-4

ABL800 FLEX Operator's Manual 1. Introduction

Limitations of use and known interfering substances,

Continued

CAUTION Known interfering substances

(continued)

Anticoagulants (sampling) Anticoagulants that contain sodium salts will

Thiocyanic acid (degradation product from treatment with nitroprussid. Also produced in thiosulphate treatment of cyanide poisoning)

Substance Interference

cNa

give erroneously high

results. Sodium fluoride with or without EDTA and oxalate (di Na) influence gives erroneously high

cGlu and cLac results. Tri sodium citrate

influences

cGlu results. Sodium fluoride

cNa

, cK+ and cGlu results.

cNa

and low cCa2+,

Thus Radiometer recommends the exclusive use of heparin as anticoagulant. Solutions containing organic preservatives may damage the ionselective membranes of the

and cGlu

electrodes when introduced into the analyzer. Do not use EDTA, as it leads to erroneous pH,

pCO

, cNa+, cK+ and cCa2+ results. Use of

EDTA will also affect subsequent measurements on the Ca electrode and it will reduce the lifetime of this electrode.

Erroneously high

cGlu and cLac measurements.

Glycolic acid (ethyleneglycol degradation product)

Insufficiently stabilized blood. Caustic fluids (e.g. strong acids or bases, detergents, etc.). Fluids that precipitate. Fluids that affect the sensor enzymes. Fluids that form complexes with the analyzer solutions (calcium). High viscosity fluids. Hydrophobic fluids. Reactive fluids.

Erroneously high cLac measurements.

Other fluids mode allows you to measure on fluids other than heparinized human blood.

Be aware that some substances, such as listed in the left column, measured in the Other fluids mode may damage the instrument or the electrodes. This can affect the subsequent measurement on human blood or quality control solutions.

Continued on next page

1-5

1. Introduction ABL800 FLEX Operator's Manual

Limitations of use and known interfering substances,

Continued

CAUTION Known interfering substances

(continued)

Carboxymethyl cellulose (CMC)

Substance Interference

Some auto-venting arterial blood samplers contain carboxymethyl cellulose (CMC) in the porous vent. CMC can dissolve into the sample and give erroneously low

cCa

results. Therefore we recommend Radiometer accessories together with our analyzers, e.g. the

safePICO arterial blood

sampler which is specifically designed to minimize sample contamination with CMC.

Galactose, glucosamine, maltose, mannose, xylose

For detailed information – see

Reference Manual

Interference Tests in chapter 5 of the ABL800 FLEX

Erroneously high cGlu measurements.

1-6

ABL800 FLEX Operator's Manual 1. Introduction

Warning/Caution and Notices

Definitions

Throughout the manual, the various procedures may contain operational cautions and warnings, which are important and should be read carefully before performing the related procedures. The manual also contains a number of

NOTICES.

The following table indicates the type of information given in Warnings, cautions and notes.

Symbol Explanation

WARNING

A warning alerts the reader about a situation, which, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards. The designation of a hazard alert as a "warning" is reserved for the most significant problems. The term

WARNING is generally used as signal word for this type of

hazard alert.

CAUTION

The term precaution is used for the statement of a hazard alert that warns the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or the patient or damage to the equipment or other property. It may also be used to alert against unsafe practices. This includes the special care necessary for the safe and effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or misuse. The word

CAUTION is

generally used as signal word for a precaution statement.

NOTICE

Notices give practical information.

1-7

1. Introduction ABL800 FLEX Operator's Manual

Symbols overview

List of symbols

The symbols below are used by Radiometer.

Symbol Explanation

Biohazard

Expiry date

See instructions for use

For In Vitro Diagnostic Use

Lot number

Sensitive to light. Store in a dark place.

Code number For single use only

Sterilized by ethylene oxide

Sterilized by irradiation

Storage temperature from 2

°C to 32 °C (36 °F to 90 °F)

Waste of Electrical and Electronic Equipment (WEEE)

The symbol indicates that:

• Radiometer Medical ApS and its distributors

within the European Union (EU) and associated states have taken the necessary steps to comply with the directive, 2002/96/EC on waste electrical and electronic equipment (WEEE).

• The instrument, when reaching its end of life,

must be collected and recycled separately from other waste according to national requirements. Please contact your local Radiometer distributor for instructions.

1-8

Environmental implications: WEEE contains materials that are potentially hazardous to

the environment and to human health.

Overview

Introduction

Contents

2. What is what

The ABL800 FLEX analyzer is a complete unit comprised of several different modules each performing a specific function and controlled by comprehensive software. The modules are collected into well-defined sections according to their related function.

This chapter describes the basic parts of the ABL800 FLEX analyzer and its software.

This chapter contains the following topics.

Analyzer - front................................................................................................ 2-2

Analyzer - rear ................................................................................................. 2-4

Measuring section ............................................................................................ 2-5

Inlet module ..................................................................................................... 2-7

FLEXQ module ................................................................................................ 2-8

Thermal printer ................................................................................................ -10 2

Communication ports....................................................................................... -11

Barcode reader ................................................................................................. -13

AutoCheck module........................................................................................... -14

Screen elements................................................................................................ -15

Menu structure ................................................................................................. -24

Analyzer status................................................................................................. -28

Online aid facilities.......................................................................................... -36

Sample counter................................................................................................. -39

2 2 2 2 2 2 2 2

2. What Is what ABL800 FLEX Operator's Manual

Analyzer - front

Parts and functions

The components of the analyzer front (with covers) is shown below.

Touch screen

Cover with window

Thermal printer

Left cover

Waste container

Capillary inlet

Syringe inlet

Right cover

Cleaning Solution

Rinse Solution

FLEXQ module

Barcode reader

utoCheck

module

Cal 1 solution

Cal 2 solution

Part Function

Color touch screen 10.4" LCD for operation and management of the

analyzer. Thermal printer For automatic printout of data. Left cover To access the waste container/Rinse Solution. Waste container For waste collection. A sensor detects when container is

full, and a message is displayed on the screen. Rinse Solution For rinsing the liquid transport system after various

analyzer activities.

2-2

FLEXQ module See FLEXQ module in this chapter. Barcode reader See Barcode reader in this chapter. AutoCheck module See AutoCheck module in this chapter. Cal 1 Solution For performing 1- and 2-point calibrations. Cal 2 Solution For performing 2-point calibrations. Cleaning Solution For cleaning the liquid transport system of lipid deposits. Right cover To access solutions and pumps – see overleaf. Syringe inlet flap Lift to introduce syringe samples and quality control

solutions. Capillary inlet flap Lift to introduce capillary samples. Cover with window See Measuring Section in this chapter.

Continued on next page

ABL800 FLEX Operator's Manual 2. What Is what

Analyzer - front, Continued

Parts and functions (continued)

The components of the analyzer front (without covers) is shown below.

pH/BG module

El/Met module

CD-ROM drive

Inlet module

Met II module

Oximetry module Solution pump

Waste pump

Magnets

Part Function

Inlet module Accepts samples from a syringe/test tube or a capillary – see

Inlet Module in this chapter.

CD-ROM drive For storing data on a CD-RW disk or retrieving data from a

CD (e.g. installation software).

CAUTION – Installation of correct software

Install only software which is strictly intended for use with the analyzer. Installation of other types may affect analyzer performance.

pH/Blood Gas (BG) module

Electrolyte/Metabolite (El/Met)

Measures pH, pO component detail.

Measures cCa

, cK+, cNa+, cGlu and cLac. See measuring

section detail.

, pCO2 and cCl–. See measuring

module Met II module Measures creatinine.

(Only available for the ABL8x7 FLEX analyzers)

Oximetry (Oxi) module

Measures ctHb, sO FHbF and ctBil. See measuring component detail.

, FHHb, FO2Hb, FCOHb, FMetHb,

Solution pump Transports solutions through the liquid transport system. Waste pump Transports liquid to the waste container. Magnets Hold the covers in place.

2-3

2. What Is what ABL800 FLEX Operator's Manual

Analyzer - rear

Parts and functions

The parts and components of the analyzer's rear panel are shown below.

Gas 1 cylinde Gas 2 cylinde

Communication ports

Fan

Gas cylinder sockets

Power switch

Power socket

Part Function

Gas 1 cylinder Contains a gas mixture of 5.61 % CO

74.64 % N

, 19.76 % O2; balance

Gas 2 cylinder Contains a gas mixture of 11.22 % CO2, < 0.04 % O2;

balance > 88.74 % N

Fan For cooling internal components. Gas cylinder

For mounting the gas cylinders.

socket Communication

See section Communication Ports in this chapter.

ports Power switch

For turning the analyzer on (position I) and off (position O).

Power socket For connecting the power cord.

In USA: If source is 120 V, use Radiometer cord 615-403

with parallel blade attachment plug. If source is 240 V, use Radiometer cord 615-405 with tandem blade attachment plug.

2-4

ABL800 FLEX Operator's Manual 2. What Is what

Measuring section

Parts and functions

The modules and components of the measuring section are shown below.

Membrane valves

Electrode module pumps

pH/BG module

Latch

Sample path

Membrane valves Control the flow of gas and solutions into the measuring

Electrode module pumps

El/Met module

Met II module

Oximetry module

Part Function

modules. Transport solutions and gas mixtures through the

measuring modules.

Latch Establishes electric contact between the electrode in the

measuring chamber and the electrode amplifier. To access an electrode, push inwards on the upper

portion of the latch, and lift upwards. Sample path Transports samples, solutions and gas mixtures. pH/BG module Contains the measuring chamber with the pH, reference,

, pO2 and cCl

pCO

El/Met module Contains the measuring chamber with the cCa

cNa

, cGlu, and cLac electrodes (a filter is installed for

–

electrodes.

, cK+,

the cGlu and cLac electrodes). Met II module Contains the measuring chamber with the cCrea A and

cCrea B electrodes

(Only available for the ABL8x7 FLEX analyzers) Oximetry module Contains the hemolyzer with glass cuvette, spectro-

photometer for measuring ctHb, sO

, FHHb, FO2Hb,

FCOHb, FMetHb, FHbF, ctBil on 128 wavelengths, and

the lamp unit.

Continued on next page

2-5

2. What Is what ABL800 FLEX Operator's Manual

Measuring section, Continued

Electrode locations

The electrodes are located in the electrode modules as follows:

cCl

electrode

cLac electrode

pCO2 electrode

electrode

Reference electrode

pH electrode

The table below describes each electrode.

Module Electrode Type

cGlu electrode

cNa

electrode

cK+ electrode

cCa2+ electrode

cCrea A electrode

cCrea B electrode

2-6

pH/BG cCl– E744 pCO2 E788 pO2 E799 Reference E1001

pH E777 El/Met cLac E7077 cGlu E7066 cNa+ E755 cK+ E722 cCa2+ E733 Met II cCrea A E8088 cCrea B E8089

NOTICE: An orange filter is placed in the measuring chambers for the cGlu, cLac, cCrea A and B electrodes.

ABL800 FLEX Operator's Manual 2. What Is what

Inlet module

Parts and functions

The inlet module accepts samples from a syringe/test tube or a capillary (the syringe and capillary inlet flaps are removed on the picture). Syringe and capillary inlet flaps are interlocked so that only one may be opened at a time.

Probe attachment

Preheater

Inlet probe

Capillary inlet flap post

Syringe inlet flap post

Capillary inlet Syringe inlet

Inlet gasket unit

Part Function

Probe attachment Secures inlet probe. Open the clip to remove probe. Preheater

Heats all samples and gases to 37 °C.

Inlet probe Automatically moves into the syringe to aspirate the

required sample. Capillary inlet flap post Holds the inlet flap for capillary samples. Syringe inlet flap post Holds the inlet flap for syringe samples. Capillary inlet Receives sample from a capillary. Syringe inlet Receives sample from a syringe and test tube. Inlet gasket unit Provides transfer of samples from a sampling device

to the inlet probe; can be removed.

2-7

2. What Is what ABL800 FLEX Operator's Manual

FLEXQ module

Parts and functions

FLEXQ module for automatic transport of samplers to the inlet is shown below.

FLEXQ position before or after analysis:

Barcode reader

Samplers

Sampler tray

FLEXQ position during analysis:

Indicator diodes

2-8

Continued on next page

ABL800 FLEX Operator's Manual 2. What Is what

FLEXQ module, Continued

Parts and functions (continued)

The components are as follows:

Part Function

FLEXQ sampler tray FLEXQ sampler tray moves to the position for

measurement by means of a step motor (not shown).

The samplers used in the sampler tray should be safePICO sampler with the safeTIPCAP.

Indicator diodes Change the color from green to yellow when the

optical switch detects the sampler placed in the slot.

Barcode reader Laser barcode reader reads the sampler barcode. A

short beep indicates that the barcode has been read. You can scan the Sampler ID on the analyzer’s scanner and then place it in the sample tray or you can place the sampler in the sampler tray and let the FLEXQ scanner read the sampler barcode.

Sampler tray cover

Mixer tray

The sampler tray cover has three slots for the samplers; the slots have optical switches for detecting the sampler. The cover can be removed (as shown) for cleaning.

The mixer rotates and moves the ball in the sampler in order to mix the blood sample. The sample is adequately mixed after 7 seconds.

The mixer tray moves into position under the sampler immediately before the measurement.

2-9

2. What Is what ABL800 FLEX Operator's Manual

Thermal printer

Parts and functions

The components of the thermal printer (with the cover open) are shown below.

Release lever

Drive rolle

Paper roll holder

Cove

Paper guide

Part Function

Release lever Push the lever fully back to lift the drive roller from the

printer head and paper guide in order to adjust paper alignment.

Remember to return the lever to its original position (as

shown) in order to print. Drive roller Feeds the thermal paper through the printer. Paper guide Located behind the drive roller, it is between this and the

drive roller that paper is fed. Paper roll holder Holds the paper roll in place. Cover Open to replace the paper roll. Contains instructions on

how to make a replacement.

Close the cover when a new paper roll has been mounted

in the printer.

2-10

ABL800 FLEX Operator's Manual 2. What Is what

Communication ports

Ports and functions

The following communication ports are available:

USB ports (two)

Mouse

Keyboard

Fuse for printer unit

Display unit

The functions of the communication ports are as follows:

Port Function

Display unit port For connection to the analyzer’s display Mouse port PS/2 connector used for the connection of a standard

mouse (user supplied).

Printer port

Network connector

Ext. VGA monitor

Serial port (COM2)

Main fuse

Keyboard port PS/2 connector used for connection of a keyboard (user

supplied). Serial port

(COM2)

9-pin serial port used for HIS/LIS communication or

connection of an external barcode reader. Network RJ45 ethernet interface connection to network. Printer port Parallel port for connection to a local printer

Continued on next page

2-11

2. What Is what ABL800 FLEX Operator's Manual

Communication ports, Continued

Ports and functions

(continued)

Port Function

External VGA monitor port

15-pin connector for external monitor (optional; is enabled

by Radiometer service representative). USB (2 ports) For connecting USB devices, e.g. a removable drive.

USB keyboard supported. Other USB devices need an

approved XP driver (user-supplied mouse or modem, etc.). Fuse for printer

unit

The compartment contains 1 protective fuse: 5 × 20 mm, 4

Amp, Slow blow (T4AL) (order code number 450-035). Main fuse The compartment contains 2 protective fuses: 5 × 20 mm,

4 Amp, High break (T4AH). Type Shurter No. 0001.2510

(order code number 450-144).

WARNING – Risk of fire

Fire hazard. Replace fuse as marked.

2-12

ABL800 FLEX Operator's Manual 2. What Is what

Barcode reader

Barcoded items

The following items have barcodes that can be read into the analyzer:

Item Location of barcode

All solution containers Label on the container QC ampoules Insert in the box containing the ampoules tHb calibration ampoules Insert in the box containing the ampoules Electrodes Label on the box containing the electrode Electrode membranes Label on the box containing the membrane unit Gas cylinders Label on the cylinder Pump tubing Label on the tubing packaging Fan filter Label on the box containing the filter Inlet gasket Label on the box containing the inlet gasket

Reading in a barcode

In addition to the items above, you can enable every text box on the Patient Profile, Patient ID, Patient Result, QC ID and Recording Fluid Replacement

screens where it is possible to enter a barcode – refer to Miscellaneous Setup in chapter 3: Installation and setup.

Hold the barcode of the item you wish to read in parallel to the sensor part of the barcode reader. A short beep from the barcode reader indicates that the information has been read in successfully.

Sensor part

2-13

2. What Is what ABL800 FLEX Operator's Manual

AutoCheck module

Parts and functions

The AutoCheck module is shown below.

utoCheck carousel

To close

To open

Retractable cover

Part Function

Retractable cover Gives access to the carousel.

You can either slide the carousel cover open or press

Menu - Analyzer Status - AutoCheck - More - Open Module.

Make sure that no objects prevent the cover from opening freely.

AutoCheck carousel Contains the AutoCheck ampoules packed according to

the optimal packing list – see Refilling the AutoCheck carousel in chapter 7: Replacements.

2-14

ABL800 FLEX Operator's Manual 2. What Is what

Screen elements

Ready screen

Operation and management of the ABL800 FLEX analyzers is performed via a touch screen. Almost all commands to the analyzer come from the touch of a button or area on the screen.

The touch screen is divided into three sections:

Top section

Center section

Top section

Bottom section

For the analyzers without the FLEXQ module, the Ready screen looks as follows:

The Ready screen appears automatically if the touch screen remains idle for more than 3 minutes. The screen intensity reduces by 50 % when the analyzer is not used.

The status bar varies slightly, according to which screen you are in and the status of the analyzer.

Example:

The status describes the current task of the analyzer (e.g. calibration, measurement, etc.) or its status (e.g. ready for use, on hold, etc.).

Continued on next page

2-15

2. What Is what ABL800 FLEX Operator's Manual

Screen elements, Continued

Top section (continued)

The time bar is present only when the analyzer is performing a task; it follows the progress of the current task. For example:

The Stop button

is visible only when it is allowed to interrupt an activity

in progress. The parameter bar lists all measured parameters available and activated on your

analyzer.

It allows you to judge the parameter status at a glance before you have to perform a measurement.

Green parameter:

Parameter status is okay; no problem is detected on the given measuring channel.

Yellow parameter:

Error associated with the given parameter during last calibration or quality control measurement. The parameter is unreliable and will have “?” (if requested in Corrective

Red parameter:

Actions) in front of the result. Serious error associated with the given measuring channel.

Parameter cannot be used at all and will be displayed as “…..”; or a parameter was repressed in the Parameter Setup program due to errors during last calibration or quality control measurement.

NOTICE: A parameter disabled in the Parameter Setup program will be removed from the parameter bar – see Analysis Setup Programs (Disabled versus Deselected Parameters) in chapter 3.

2-16

Continued on next page

ABL800 FLEX Operator's Manual 2. What Is what

Screen elements, Continued

Center section

The center section is the main information and interaction area of which there are many different types.

The center section of the Ready screen is described part by part, starting from the top (for the analyzers without FLEXQ module the center part contains the analyzer type and – if entered in Miscellaneous Setup (see chapter 3) – analyzer message).

This part of the Ready screen contains the following elements:

• Analyzer name

• The messages to the operator regarding the FLEXQ activities

• Urgent Manual Sample request button. The button allows you to book an inlet

for an urgent measurement while the analyzer performs a task. The button is grayed out when the analyzer is ready for any measurement.

This part of the Ready screen contains the following elements:

• "Slot #": condition of each sampler tray slot (1, 2 and 3) is indicated with the arrows that reflect the indicator diodes in the sampler tray:

Green Place the sampler into the slot

or remove it from the slot.

Blinking green

Wait for the sampler to be identified.

Yellow Do not remove the

sampler from the slot.

Blinking yellow

Remove the sampler from the slot.

• "Sampler ID": appears when the sampler is placed in the sampler tray slot and is registered. The name of this column can be changed in the Sample Logistics Setup (see Analysis Setup in chapter 3 of this manual).

• "Time to Result": shows time left till a result will be ready; the clock indicates that the sample age has exceeded settings selected in Sample Logistics setup.

• "Status": gives information about a sampler in the slot:

Slot empty A slot is ready to accept a sampler. Ready for processing Sampler has been registered in the slot. Processing Patient and sampler data are being processed. Completed Measurement is completed and the result can be

viewed.

Continued on next page

2-17

2. What Is what ABL800 FLEX Operator's Manual

Screen elements, Continued

Center section

(continued)

Patient data can be edited.

Result can be viewed.

This part of the Ready screen is reserved for the analyzer messages and is entered in the Miscellaneous Setup (see chapter 3 in this manual):

Other screen types and their elements are described on the following pages. Icon and screen name identify each screen. Example:

Icon

Screen name

2-18

The icon and title of a screen are the same as the button that gives access to that screen.

Continued on next page

ABL800 FLEX Operator's Manual 2. What Is what

Screen elements, Continued

Center section (continued)

Text boxes show a text in the form of

lists, items, tables, etc. Various types of text boxes and navigation in them are given on the next page.

The first line is highlighted. To highlight another line, touch it on the screen or use up and down arrow scroll keys displayed on the screen beside a relevant text box.

A scroll bar scrolls a text box horizontally when the text box extends beyond the area available on the screen.

A single-arrow scroll button highlights one item at a time upward or downward.

Scroll bar

Scroll keys

A double-arrow scroll button highlights an item at the top or the bottom of the screen.

The first line is highlighted. To highlight another line, use the up and down arrow buttons or touch this line in the box.

Enter the data using the screen keypad or keyboard.

In this text box you can select one of the predefined options.

Use the up and down arrow buttons to select an item.

NOTICE: If the text box already contains an entry, it will be overwritten and cannot be retrieved.

Text boxes are designated in quotation marks, e.g. "Operator". The same applies to the other elements on the center section of the screen: names of the columns (e.g. "Status"), input fields (e.g. "Draw time"), etc.

Continued on next page

2-19

2. What Is what ABL800 FLEX Operator's Manual

Screen elements, Continued

Center section (continued)

Check buttons allow you to enable/disable or select/deselect an item on the

screen. For example:

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

Parameter is selected.

RADIANCE system) A function is deselected or

deactivated.

Parameter is deselected.

Screen keypad allows the entry of numerical data on the screen.

umerical keys

from 0 to 9.

Decimal point.

The buttons listed below have the following functions:

Press to confirm a numerical entry and to highlight the next line in the text box.

Press to delete a character (from right to left) or to type in the new data (the box is cleared as soon as the first character is typed).

Press to display the full alphanumerical keyboard.

Continued on next page

2-20

ABL800 FLEX Operator's Manual 2. What Is what

Screen elements, Continued

Center section (continued)

Screen keyboard is used for entering both alphabetical and numerical data − see

the description on the next page.

ctivated text box

The keyboard functions as a normal keyboard with alphabetical and numerical characters. The typed text appears in the activated text box.

Enter

Press to confirm the entry and to return to the previous screen. Backspace

Press to delete characters from right to left. Press to cancel any changes made in the activated text box and

to return to the previous screen Press to delete an entry in the activated text box.

Shift Press to type a capital letter or symbol.

Press to lock the keyboard in order to type capital letters and symbols on the numerical keys. When activated, indicator is green.

Up/down/left/right arrows move the cursor in the activated text box in order to edit a text.

Continued on next page

2-21

2. What Is what ABL800 FLEX Operator's Manual

Screen elements, Continued

Buttons

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

Information bar and icons

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 button in a weaker color,

i.e. grayed-out, is temporarily inactive. The buttons at the top and the bottom of the screen can be selected in the Setup

program Access Profiles (in the Analyzer Security menu) together with the access profiles for each operator – for detailed information see the description in chapter 3: Installation and setup.

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 Ready screen.

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

2-22

Continued on next page

ABL800 FLEX Operator's Manual 2. What Is what

Screen elements, Continued

Information bar and icons (continued)

The following icons are available on the information bar:

Icon Function

Shows the current time in the selected format.

Shows that an analyzer is connected to the RADIANCE system.

Shows that an analyzer is connected to the QA Portal.

Shows the time of the next scheduled calibration. The time changes when a calibration has been completed.

Shows the time of the next scheduled QC measurement. The time changes when a QC measurement has been completed.

Shows that the remote operator is connected.

Click to make more icons visible.

Click to reduce the number of visible icons to a clock.

2-23

2. What Is what ABL800 FLEX Operator's Manual

Menu structure

Menu at analyzer startup

When the analyzer is taken into use, only the following limited menu is available:

Press Menu.

Calibration Progs:

1 Point Calibration 2 Point Calibration

Auxiliary Progs:

Rinse Cleaning Protein Removal Decontamination

AutoCheck Programs Run High Crea Check

(only the ABL8x7 analyzers)

Log on

Analyzer Status Help

Start Progs

Utilities

Standby

Temporary Shutdown

Last patient result

Tutorials

Data Logs

Patient Results Log

Patient Profile Log

QC Log

Calibration Log

Activity Log

Allowed actions at analyzer startup

2-24

The following actions are allowed at analyzer startup:

To perform a measurement

• To call a calibration

• To edit data in the data logs

•

To perform a replacement

•

To start an AutoCheck measurement

•

The menu above and the scope of actions are suitable for those users whose activities include performing measurements and occasional replacements.

Continued on next page

ABL800 FLEX Operator's Manual 2. What Is what

Menu structure, Continued

Entering standard password

To access the complete menu, do the following:

Step Action

Press Menu on the Ready screen.

Then click on Logon. Type in the standard password: 123456.

Standard password:

123456.

See chapter 3: Installation and setup, Analyzer Security, in this manual for further information about the logon possibilities.

Confirm with Enter. Press Menu to access the complete menu – see the next section.

The access possibilities for each user of the analyzer and their passwords are entered in Setup program Access Profiles – see chapter 3: Installation and setup in this manual.

Continued on next page

2-25

2. What Is what ABL800 FLEX Operator's Manual

Menu structure, Continued

Complete menu

Press Menu.

My results*

Last patient result

Calibration Progs:

1 Point Calibration 2 Point Calibration tHb Calibration

Auxiliary Progs:

Rinse Cleaning Protein Removal Decontamination Liquid Sensor Adjust Pump Calibration Tubing Refill

AutoCheck Programs

Run High Crea Check

(only the ABL8x7 analyzers)

Log on

Analyzer Status

Start Progs

Disk Functions:

WDC Report Back up All Data Restore All Data

Export Data Logs

Import/Export Archives

Save Setup Load Setup

Restore Default Setup

Eject CD

Utilities

Help

Tutorials

Data Logs

Standby

Sample Counter

Temporary

Shutdown Long-term Shutdown

RADIANCE Browser

(optional)

Patient Results Log

Patient Profile Log

QC Log

Calibration Log

Activity Log

Archived Data Logs

Patient Report

Analyzer status

Analyzer status at a glance

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 facilities:

• parameter bar

• color of the traffic light on the Analyzer Status button.

Analyzer Status elements

nalyzer Status button

Red = cannot be used; Yellow = unreliable; Green = OK

To enter the Analyzer Status screen, press Menu - Analyzer Status.

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

Status element The colors indicate…

Calibration Status

REEN – OK.

ELLOW – error(s) in the last calibration and/or cal

schedule reminders.

RED – error-prone parameters are repressed.

Continued on next page

2-28

ABL800 FLEX Operator's Manual 2. What Is what

Analyzer status, Continued

Analyzer Status elements

(continued)

Button The colors indicate…

Quality Control Status

REEN – OK.

ELLOW – error(s) in the last QC measurement and/or

QC schedule reminders.

Calibrations status

Reagents Status

RED – error-prone parameters are repressed. G

REEN – no replacements due at the present time.

ELLOW – a replacement is due, Calibration/Cleaning

solutions expire soon or Calibration/Cleaning solutions have expired.

Electrode and others System Messages

REEN – no replacements due at the present time.

ELLOW – a replacement is due.

REEN – no (critical) messages.

ELLOW – non-critical messages.

ED – critical messages. The analyzer cannot

calibrate or measure.

AutoCheck Status

REEN – no replacements due at the present time.

ELLOW – a replacement is due.

The Calibrations status gives an overview of the status of the most recently performed calibration of each type and relevant messages.

The following information is available on the screen:

Calibration Type Lists each calibration type along with its status:

Calibration was accepted. Error(s) detected during calibration. Pending or overdue calibration. The last

calibration was accepted.

Continued on next page

2-29

2. What Is what ABL800 FLEX Operator's Manual

Analyzer status, Continued

Calibration status

(continued)

Calibration Type Lists each calibration type along with its status:

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

Last Time The date and time the last calibration of the specified type

was performed.

Next Time The date and time the next calibration of the specified

type is due according to the Calibration Schedule - see Calibration Schedule, chapter 3.

Interval The time interval between calibrations as set up in the

Calibration Schedule.

The following buttons are available:

During a calibration:

Result Electrode Upd.

After a calibration:

Result

Press to display the result of the highlighted calibration. Press to display the electrode updatings for the ongoing

calibration.

Press to display the result of the highlighted calibration.

2-30

Start Calibration

Is activated for the overdue calibrations or the calibrations with "?".

Continued on next page

ABL800 FLEX Operator's Manual 2. What Is what

Analyzer status, Continued

Quality Control status

The Quality Control status provides the following information:

status of the last measurement on each control solution type

• messages referring to quality control measurements.

•

For the ABL8x7 FLEX analyzers, please note that Slot 11 will be automatically installed when you scan the barcode for the Cleaning Met II Solution during replacement.

Element Function

Solution Lists the quality control slot and its solution type along

with a status symbol. Cleaning Met II Solution (for ABL8x7 FLEX analyzers

only) is used for quality control of high creatinine levels. OK ?

The last measurement was accepted. One or more of the following occurred:

• error in the last calibration.

• analyzer error during last QC measurement.

• a parameter measurement is outside the defined

ranges or a Westgard Rule has been violated.

The next measurement is overdue, and the previous measurement, if any, was accepted.

The last quality control measurement had errors present, and the next measurement is overdue.

Lot The solution lot number for the slot. Last Time Lists the time the last measurement was performed. Next Time Lists the next scheduled time to perform the measurement

on the slot. See Quality Control Schedule, chapter 3.

Continued on next page

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2. What Is what ABL800 FLEX Operator's Manual

Analyzer status, Continued

Quality Control status (continued)

Buttons:

Run AC ampoule

Press to start a measurement on the highlighted AutoCheck solution.

For ABL8x7 FLEX analyzers only: When Slot 11 is highlighted, this button changes to Run High Crea Check to start a measurement on the Cleaning Met II Solution.

Reagents status

Result

Press to display the last measurement result on the control solution.

The Reagents status shows the following:

status of the solutions and gas cylinders

• When Calibration/Cleaning solutions are expired, the container in question

is marked with a clock above it and the contents are colored orange. messages referring to solutions and gas cylinders.

•

2-32

Buttons:

Replace

Press to enter the screen for replacements of fluids – see chapter 7: Replacements.

Adjust Level

Press to enter the Solution Level Adjustment program to make adjustments – see chapter 3 in this manual.

Troubleshoot

Press to view the error interpretation and operator actions – see the description in chapter 11: Troubleshooting.

Press to exit to the Ready screen.

NOTICE: The Calibration and Cleaning Met II Solution containers are filled so

that they provide up to 14-days of use in the ABL8x7 FLEX analyzer. This will be registered on the screen by percentages that are lower than 100 % (i.e. 87%, 75%, 50% for the Calibration Solution 1, Calibration Solution 2 and Cleaning Met II Solution, respectively). This has been made so that the solution warning function will not be impaired and you can select the warning values in the usual manner.

Continued on next page

ABL800 FLEX Operator's Manual 2. What Is what

Analyzer status, Continued

Electrodes and Other status

The Electrodes and Other status shows the following:

replacement schedule for items replaced in the Hold mode

•

messages referring to replacements or user activities.

•

System messages

AutoCheck status

Buttons:

Replace

Highlight the item and press this button to enter the screen for replacements of electrodes/membranes – see Replacing membrane or electrode in chapter 7.

Log Activity

Activate “User Activities” part of the screen to make this button visible. When the button is visible, press it to enter the User Activity program to edit the user activities list – see chapter 3 in this manual.

Press to exit to the Ready screen.

See chapter 11: Troubleshooting.

AutoCheck Status is available only if the AutoCheck module has been installed. It shows the following:

status of the carousel and the measurements scheduled in the QC Schedule

• program (see section Quality control setup in chapter 3).

Messages referring to AutoCheck.

•

Continued on next page

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2. What Is what ABL800 FLEX Operator's Manual

Analyzer status, Continued

AutoCheck status (continued)

Element Function

Next Scheduled To show the next AutoCheck solution/lot combination

according to the scheduled setup.

Next Replacement To show the date and time for refilling the carousel

according to the scheduled setup.

Available To show the presently available AutoCheck control

solutions: type, lot and quantity of ampoules in the carousel.

Use the up/down arrow buttons to highlight the desired solution.

Continued on next page

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ABL800 FLEX Operator's Manual 2. What Is what

Analyzer status, Continued

AutoCheck status

(continued)

The carousel shows the number of ampoules available in it. The black spots indicate used ampoules.

Button

Packing List Reset

Open Module AutoCheck

Programs

unrolls to access the following buttons:

Displays the Optimal Packing List screen.

Cancels any pending quality control measurements.

•

Interrupts ampoule conditioning in the carousel.

•

Resets wet section programs.

•

Opens the cover of the AutoCheck module. Displays the AutoCheck Programs screen to start an

AutoCheck measurement.

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2. What Is what ABL800 FLEX Operator's Manual

Online aid facilities

Online facilities

Help

The online aid facilities include the following:

• Online Help

• Tutorials

• Online troubleshooting (see chapter 11 in this manual).

This function assists you in using the analyzer.

Press the button in the Main menu (if not moved to the Ready screen – see Access Profiles (in the Analyzer Security menu) in chapter 3) or on the Ready screen.

The help text is available for practically every screen your analyzer shows during its operation.

The Contents screen displays all help topics. Each topic is hyperlinked to either the next topic level or to the appropriate help text screen.

Use the scroll bar or touch the text to search through the topics and access the relevant help information. Press the Previous Topic button to display the help text of a previous screen.

The Index screen is an alphabetic list of subjects in the help program.

Each letter at the top of the screen is a hyperlink to that section in the index.

Touch the letter to display the list of entries under that letter.

Each index entry is displayed in bold, purple text (a hyperlink). Simply touch the text to display the relevant help text.

Continued on next page

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ABL800 FLEX Operator's Manual 2. What Is what

Online aid facilities, Continued

Tutorials

Tutorials are short video sequences of commonly used procedures. Press the

button in the main menu or button next to the

Troubleshooting button (when performing troubleshooting) to enter the Tutorial Playlist screen.

The Preview shows the highlighted sequence animation. To start a tutorial on full screen, highlight the topic of interest from the menu, using the arrows, and press the Play button.

Topic Contents

Blood Samples Videos of a capillary, syringe or expired air sample

introduction by highlighting it. Quality Check Videos of manual or AutoCheck quality control. Replacement Video sequences on various replacements.

The buttons on the Tutorial screen during a sequence allow to do the following:

Continued on next page

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2. What Is what ABL800 FLEX Operator's Manual

Online aid facilities, Continued

Tutorials (continued)

Button Function

Play.

Pause.

Stop.

Show previous picture – show next picture.

Switch on the sound (voice presentation of a sequence) with volume regulation.

Switch off the sound.

Show the list of video sequences.

The "-" button puts Tutorials in the background in order to perform an action and then to return to Tutorials again.

The "x" button exits Tutorials.

When a button is grayed out, it is not functional.

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ABL800 FLEX Operator's Manual 2. What Is what

Sample counter

Purpose

Description

The sample counter allows you to keep track of the measurements, calibrations and quality control.

The screen elements are described below:

Element Function

Parameter Count

Lists the parameters and how many times each of them was measured by the analyzer. Normally the count is the same as the total number of measurements provided the parameters were not excluded from the measurement(s).

Counters Shows the number of sample measurements, calibrations and

QC measurements made since the sample counter was last reset (User column). The following is registered:

Activity Number of...

Total Completed sample/quality control measurements/

calibrations only. Interrupted or aborted measurements are excluded.

Aborted Aborted sample/quality control measurements/

calibrations due to sample errors, wet section errors, etc. interrupted measurements excluded.

User All completed sample/quality control

measurements/calibrations performed by all operators since the sample counter was last reset.

User counters last reset

Gives the date when the counters in the User column were last reset to zero.

Continued on next page

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2. What Is what ABL800 FLEX Operator's Manual

Sample counter, Continued

Description

(continued)

Element Function

Reset Counters

For the analyzers with no logon protection of the Setup programs, press this button to reset the counters in the User column.

Press to start the printout of information in Counters and in Parameters.

Press to return to the Ready screen.

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Overview

Introduction

Contents

3. Installation and setup

After the analyzer has been installed, you can define the settings on your ABL800 FLEX analyzer according to your own needs and requirements.

This chapter contains the following topics.

Installation........................................................................................................ 3-2

Setup menu structure........................................................................................ 3-3

Analyzer security ............................................................................................. 3-6

Analysis setup .................................................................................................. 3-13

Patient reports .................................................................................................. 3-26

Calibration setup .............................................................................................. 3-32

Quality control setup........................................................................................ 3-35

Replacement setup ........................................................................................... 3-48

Parameters and input setup............................................................................... 3-55

Analyzer settings.............................................................................................. 3-62

Communications .............................................................................................. 3-68

Printers............................................................................................................. 3-77

Disk Functions setup........................................................................................ 3-80

Corrective actions ............................................................................................ 3-83

Miscellaneous setup......................................................................................... 3-86

3. Installation and setup ABL800 FLEX Operator's Manual

Installation

Information

The ABL800 FLEX analyzers are installed and fully prepared for use by Radiometer representatives in your country. The reason for it is that − due to the analyzer's modular design − each user can select only those modules that cover his/her specific needs. These modules are installed and checked at the user's place.

Installation of consumables and accessories are exactly the same as the procedures described in chapter 7: Replacements.

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ABL800 FLEX Operator's Manual 3. Installation and setup

Setup menu structure

Accessing Setup programs

To access the Setup programs, press the buttons:

−

Setup menu structure

Setup

Analyzer Security:

General Security

Operators and Passwords

Access Profiles

Replacement Setup:

Replacement Schedule

User Activities

Solution Level Forecast

Solution Warning

Expiration Warning

AutoCheck Warning

Calibration Setup:

Cal Schedule

Drift Tolerances

Print Setup

QC Setup:

QC Solutions QC Schedule

QC Ranges

QC Input Setup

QC Statistics

Westgard Rules

Rilibäk Ranges

Analysis Setup:

Capillary Modes

Syringe Modes

Patient Reports

Reportable Ranges

Reference Ranges Sample Pre-registration Sample Logistics Setup

General Setup

See the next page

Continued on next page

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3. Installation and setup ABL800 FLEX Operator's Manual

Setup menu structure, Continued

Setup menu structure (continued)

Printers:

Printer Setup

Automatic Printing

Analyzer Settings:

Analyzer ID

Time/Date

Acoustic Signal

Environment

Language

General Setup

Communications:

RADIANCE Connection

LIS/HIS Connection

QA Portal

Automatic Data Transmission

Automatic Data Request

Patient Lookup Setup

Remote Support

Parameters and Input:

Parameters

Units

User-defined Data Items

User-defined Notes

Disk Functions Setup:

Automatic Backup

Automatic Archiving

Miscellaneous Setup

Corrective Actions

Note that the exit from a setup program returns you to the Ready screen. You will find it more convenient to place some buttons, e.g., Utilities, on the Ready screen to shortcut the entry to a desired setup program - refer to Access Profiles program (in the Analyzer Security menu) in chapter 3.

Continued on next page

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ABL800 FLEX Operator's Manual 3. Installation and setup

Setup menu structure, Continued

Entering password

To enter the Setup programs, do the following.

Step Action

Press Menu on the Ready screen.

Then click on Logon. Depending on the authentication setting chosen in the General

2. Security screen, enter or scan your user name and password, or your

logon-barcode.

Print Setup

Confirm with Enter.

This program allows you to print parts of the setup. To select the parts of the setup for printing, do the following:

Step Action

Press Menu – Utilities − Setup − Print Setup. All setups are selected as a default.

Press the relevant check buttons to deselect the setup that you do not wish to be printed out.

Press Print to start printout of the selected setups or press Close to

return to the Ready screen.

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3. Installation and setup ABL800 FLEX Operator's Manual

Analyzer security

Programs

General Security

Analyzer Security programs are described in this section.

This program allows you to hand over the control of the operators and passwords to the RADIANCE system and to allow an anonymous use of the analyzer.

To enter this program, press Menu – Utilities – Setup – Analyzer Security – General Security.

To hand over the control of the operators and passwords to the RADIANCE system activate the check button in the "Centralized User Management" box.

With this option enabled you can only view the operators, not add, edit or remove any of them. All users defined on the ABL are deleted and the list of users in the RADIANCE system is copied to the ABL.

NOTICE: This option can only be enabled if RADIANCE communication is enabled in the RADIANCE Connection Setup program.

3-6

Continued on next page

ABL800 FLEX Operator's Manual 3. Installation and setup

Analyzer security, Continued

General Security

(continued)

To define, how the user should log on, use the up/down arrow buttons in the "Authenticate" box to select the desired logon option. The following options are available:

• UserId/Password as primary

This option allows you to enter or scan a User name and password in the Logon screen. By pressing the Log On BC button a Logon-barcode can be scanned.

• UserId/Password only This option allows you to enter or scan the user name and password in the Logon screen.

• Logon-barcode as primary This option allows you to enter or scan a Logon-barcode in the Logon screen. By pressing the Extented Log On button a user name and password can be scanned.

• Logon-barcode only This option allows you to enter or scan a Logon-barcode in the Logon screen.

To allow an anonymous use of the analyzer, i.e. use without logon, use the up/down arrow buttons to select "Yes" in the "Anonymous use" box (default) and select the desired access profile of the anonymous operator, in the "Access profile for anonymous operator" box. The "Access profile for anonymous operator" box only appears, when "Yes" is chosen in the "Anonymous use" box. See Access Profiles further in this chapter for information on how to define the access profiles.

To set the time interval to elapse, before an operator is automatically logged off, press the Logoff Time button. Select the logoff time in minutes (from 0 to 60) and seconds (from 0 to 50 in 10-second intervals). The default logoff time is three minutes. Press Back to return to the General Security screen.

Continued on next page

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3. Installation and setup ABL800 FLEX Operator's Manual

Analyzer security, Continued

Operators and Passwords

This program allows you to add, edit or remove operators and to assign an access profile to each operator.

NOTICE: If the Centralized User Management option is enabled in the General Security screen, you cannot add, remove or edit the operators, but only view the

access profiles of the individual operators. To enter the Operators and Passwords program, press Menu – Utilities – Setup –

Analyzer Security – Operators and Passwords.

Shows the list of available operator profiles

Shows the list of actual operators

When the analyzer is taken into use, the following default operators are available:

Operator Has access to…

Manager All menu items and programs (not service programs). It is

recommended to remove this operator with the standard password: 123456, and enter the actual users with their profiles and passwords.

Radiometer All menu items and programs (user and service) on the

analyzer. Note that "Radiometer" cannot be removed from the operator list.

Remote operator Only if the Remote Support option key is installed.

Continued on next page

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ABL800 FLEX Operator's Manual 3. Installation and setup

Analyzer security, Continued

Operators and Passwords (continued)

To add an operator to the list, do the following:

Step Action

Press the Add Operator button to display the Add New Operator

screen.

Type the name of the operator or operator category in the "Operator

ID" box, using the screen keyboard. Enter or scan the password: in the "Password" box.

The password must be at least four characters long, and not more than

32. Re-enter or re-scan the password in the "Confirm" box.

Enter or scan the logon barcode in the "Logon – barcode:" box

The logon barcode must be at least four characters long. The logon barcode and the password can be identical.

Re-enter or re-scan the logon barcode in the "Confirm" box.

Press Back.

If the password is not accepted, the Add New Operator screen remains open and a message, telling you what was wrong, appears.

If the password is accepted, the Operators and Passwords screen is displayed.

In the Operators and Passwords screen, select the desired access

profile of the new operator.

Continued on next page

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3. Installation and setup ABL800 FLEX Operator's Manual

Analyzer security, Continued

Operators and Passwords (continued)

To remove an operator from the list, use the up/down arrow buttons in the "Operator" box to highlight the operator and press Remove Operator.

NOTICE: If the Centralized User Management option is enabled in the General Security screen you cannot add, remove or edit the operators, but only view the

access profiles of the individual operators.

Access Profiles

This program allows you to define the permitted actions, the available menu items and button shortcuts of an access profile.

To enter this program, press Menu – Utilities – Setup – Analyzer Security – Access Profiles.

To define the permitted actions of an access profile, select the desired profile in the "Profile names" box and activate the desired check buttons in the "Permitted actions" box.

To deactivate an action, press the check buttons once again.

3-10

Continued on next page

ABL800 FLEX Operator's Manual 3. Installation and setup

Analyzer security, Continued

Access Profiles

(continued)

To define the available menu items and button shortcuts of an access profile do the following:

Step Action

In the Access Profiles screen highlight the desired access profile in

the "Profile names" box and press Menus and Buttons. Note that this button is grayed-out for the service technician profile. Select the desired menu items in the "Menu Items in Quick Menu"

box.

Selected profile

is named on the screen.

A grayed-out item in the Menu & Button Configuration screen indicates that only some subitems were selected in this group. Clear checked items indicate that all subitems have been selected.

The buttons allows you to do the following:

Open/close submenus

Highlight menu items

Select/deselect a menu item

Continued on next page

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3. Installation and setup ABL800 FLEX Operator's Manual

Analyzer security, Continued

Access Profiles

(continued)

Step Action

To create a button shortcut for a specific item, highlight the desired

item in the "Menu Items in Quick Menu" box and then, in the "Button configuration" box, press the button position that you wish to give the selected item.

Select other five buttons in the same manner, if desired.

To deselect a button, press it once again.

5. Press Back to return to the Access Profiles screen.

Enabling the “My Results” option will give the operator an easy access to all Patient Results made by that operator, by displaying the Patient Result Log, filtered on the operator name.

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ABL800 FLEX Operator's Manual 3. Installation and setup

Analysis setup

Programs

Analysis Setup programs are described in this section.

Activate a button to enter the program.

Syringe Modes and Capillary Modes Setup

The Syringe Modes Setup and Capillary Modes Setup are shown below:

To select a measuring mode

To enable a mode

The activated button will be selected as default mode when opening the inlet

Continued on next page

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3. Installation and setup ABL800 FLEX Operator's Manual

Analysis setup, Continued

Selecting a measuring program

To select a measuring program, do the following:

Step Action

NOTICES:

Blood, pleura and expired air samples

: Press the desired mode button, enable it and select the desired measuring program with the arrow buttons.

Other fluids:

Activate the desired mode button and enable the Other

fluids check button. Press Parameters to select a parameter profile for a measuring

program − see Selecting parameter profile below. Edit, if desired, the left part of the button name for the mode by

pressing Edit Name. Enter corrections for the Other fluids mode by pressing Corrections −

see Entering corrections for Other Fluids Modes further in this section.

Select the report layout for a measuring program by pressing Layout − see Selecting a report layout further in this section.

You can use one of the syringe measuring modes for test

•

tubes.

•

Use Capillary − 35 μL OXI for bilirubin analysis (ctHb = 0) on plasma. Deselect all other parameters for this mode in the Parameter Profile. Alternatively, you can use the Other Fluids mode for the bilirubin measurement on plasma (this is not relevant for the ABL8x7 FLEX analyzers).

In the Syringe Modes Setup and Capillary Modes Setup

•

screens you can define up to 12 measuring programs. To get access to the last 6 mode buttons press Next Page.

Continued on next page

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ABL800 FLEX Operator's Manual 3. Installation and setup

Analysis setup, Continued

Selecting parameter profile

To select parameter profile for each measuring program, do the following:

Step Action

Select a measuring program and press Parameters on the Syringe

1. Modes Setup or Capillary Modes Setup screen.

Select parameters for a given measuring mode by pressing a parameter

check button (see Screen elements in chapter 2). The list of available parameters depends on your analyzer version.

Disabled versus deselected parameter

Select the dynamic parameters option in the "Use dynamic

parameters" box as follows:

Parameters can be selected before a measurement.

Press the Back button to return to the Syringe Modes Setup or

Parameters can be selected after a measurement.

Capillary Modes Setup screen.

A parameter is disabled, i.e. excluded from the Parameter Profile screen and the parameter bar, in General Setup − Parameters and Input – Parameters.

A parameter deselected

for the given syringe or capillary measuring program will

be measured, but excluded from the displayed and printed patient report. You can further select or deselect a parameter before or after a measurement − see

chapter 4: Sample measurements.

Continued on next page

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3. Installation and setup ABL800 FLEX Operator's Manual

Analysis setup, Continued

Selecting HbF correction

To give the user the possibility of selecting or deselecting HbF correction during a measurement, do the following:

Step Action

Select HbF correction for all levels or for HbF levels higher than 20 %

in Miscellaneous Setup (Setup − General Setup − Miscellaneous Setup) – see the description further in this chapter.

Return to the Analysis Setup, choose the desired syringe or capillary

2. program and press the Parameters button to enter the Parameter Profile screen.

Activate the check button in the "Use HbF correction" box (if

"Disabled for all levels" has been selected in Miscellaneous Setup, the text box and the check button in it will not be visible on this screen).

Press the dynamic parameters check button in the “Use dynamic

parameters” box in order to be able to exclude the HbF correction and other parameters during a sample measurement.

HbF correction was disabled in Miscellaneous Setup

Continued on next page

3-16

ABL800 FLEX Operator's Manual 3. Installation and setup

Analysis setup, Continued

Entering corrections for Other Fluids mode

The Other Fluids mode allows measurement on samples other than heparinized whole human blood and, therefore, requires entering corrections (offset and slope).

Step Action

Select the Other Fluids mode and press the Corrections button on one

of the Modes Setup screens (Capillary or Syringe). Highlight the parameter with the arrow buttons and press Edit.

Key in the slope and offset values. Confirm each entry with Enter.

Please note that only values within the range programmed into the software will be accepted.

Press Back to confirm the entries and return to the previous screen.

To delete a correction, highlight it and then press the

−

Remove

button.

Continued on next page

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3. Installation and setup ABL800 FLEX Operator's Manual

Analysis setup, Continued

Selecting a report layout

To select a report layout for a measuring program, do the following:

Step Action

Select a measuring program.

Press the Layout button on one of the Mode Setup screens.

Select the layout for the measuring program from the list made in the

Patient Report Setup – see Patient report further in this chapter. The selected layout will be the default layout for the given measuring program.

Press Back to confirm the settings.

Continued on next page

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ABL800 FLEX Operator's Manual 3. Installation and setup

Analysis setup, Continued

Reference ranges and critical limits

Viewing the reference ranges and critical limits

This program allows you to enter your own reference ranges and critical limits for all measured and calculated parameters. For each parameter, you can choose whether or not to differentiate between the categories of sample type, sex and age group.

Press the check button to activate a function; press the check button again to deactivate it.

To view the reference ranges and critical limits, highlight a parameter in the "Parameter list" box using the arrow buttons.

Selecting sample type

Selecting sex

View the settings for a highlighted parameter

To select a sample type, highlight a parameter in the "Parameter" box, using the arrow buttons.

Press the check button in the "Sample type" box and select a sample type, using the arrow buttons in the box.

To deactivate sample type differentiation, press the check button again.

To select sex, highlight a parameter.

Press the check button in the "Sex" box and select sex type, using the arrow buttons in the box

To deactivate sex differentiation, press the check button again.

Continued on next page

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3. Installation and setup ABL800 FLEX Operator's Manual

Analysis setup, Continued

Setting age group limits

To set the age group limits, do the following:

Step Action

Press the Age groups button to display the following screen:

Use the following:

0 days-1 month, 1-5 months, 5-8 months, >8 months"

Setting reference and critical limits

• left/right arrows to choose the age group limit you want to alter

(indicated by a blue circle containing a white cross).

• up/down arrows to scroll through the list of possible age limits. As

the list is scrolled the text on the age group bar changes accordingly.

Repeat step 2 for each limit to be changed.

3. Press Back when completed to return to the Reference Ranges and

4. Critical Limits screen.

Activate the Age group check button.

To deactivate age group differentiation, press the check button again.

To set the reference and critical limits for each parameter do the following:

Step Action

Highlight a parameter by using the up/down arrow buttons.

3-20

Choose the sample type, sex, age group and press the Edit button.

Continued on next page

ABL800 FLEX Operator's Manual 3. Installation and setup

Analysis setup, Continued

Setting reference and critical limits

(continued)

Step Action

To remove all current ranges, press the Clear limits button.

To change the value in a range limit, touch and highlight the range.

Then enter the limit, using the screen keyboard and confirm with Enter.

Reportable ranges

Repeat for other limits in a similar way.

Press Back when completed.

To change or enter a reportable range (must be selected smaller than or equal to the measuring range), do the following:

Step Action

Scroll to the desired parameter, using the up/down arrows or scroll

bar.

Measured parameters show their measuring ranges. Derived parameters show

“.....”

Key in the desired lower limit and confirm with Enter on the keypad.

Key in the upper limit and confirm with Enter on the keypad.

To change the reportable range to the default (primary) setting,

highlight the desired parameter and press Set Default.

Continued on next page

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3. Installation and setup ABL800 FLEX Operator's Manual

Analysis setup, Continued

Reportable ranges

(continued)

Step Action

To change all parameters to the default values, press the 1-n Set All

Default button.

Press Continue to change all parameters’ reportable ranges to the default ones.

Press Cancel to keep the user-defined reportable ranges and return to the previous screen.

Sample Preregistration setup

Press Close to exit the program and confirm the selected settings.

See also Calibration verification in chapter 15 in this manual.

This program allows you to select interpretation of the barcode and the patient data that can be confirmed before a sample measurement.

To select the settings, do the following:

Step Action

Use the up/down arrow buttons to select the interpretation of the

barcode setting in the "Interpret barcode input as" box.

3-22

Choose one of the following:

• Patient ID

• Accession Number

• Sampler ID.

Continued on next page

ABL800 FLEX Operator's Manual 3. Installation and setup

Analysis setup, Continued

Sample Preregistration setup

(continued)

Sample Logistics Setup

Step Action

Note that choosing the Accession Number or Sampler ID will gray out

(cont.)

its check button (Sampler ID on the screen above). Choosing the Accession Number or Sampler ID ensures that this data will be included in the "Data confirmation" box.

Select the barcode entry.

Activate the relevant check buttons in the "Included fields" box:

Accession Number, Sampler ID, Patient First Name, Patient Last Name, Birth Date, Patient Sex.

Activate the check button in the "Data confirmation" box so that the

patient data can be confirmed before the sample measurement. Press Close to confirm the settings and return to the Ready screen.

This program allows you to select the following: the batch mode (automatic sample handling), Patient Identification shown on the Ready screen and to define maximum allowed sample age for each measured parameter.

Batch mode (automatic sample handling)

The batch mode allows you to place your sampler in an empty slot in the FLEXQ sampler tray and leave the analyzer. The sampler will be registered, sample analyzed and the results sent to the required person.

To achieve this the following is required:

• Analyzer has live connection to the RADIANCE system

• Barcode interpretation is set to Sampler ID in the Sample Pre-registration

• "When entering Sampler ID" in "Request patient demographics" box is selected

and "From connection" must be set to RADIANCE in the Automatic Data Request setup

• All sample/patient information is present on the RADIANCE system

Continued on next page

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3. Installation and setup ABL800 FLEX Operator's Manual

Analysis setup, Continued

Batch mode (automatic sample handling) (continued)

Patient identification on the Ready screen

Sample age

If the above requirements are fulfilled, activate the check button in the "FLEXQ" box. This box is not available for the analyzers without the FLEXQ module.

If a live RADIANCE connection is detected, the analyzer will automatically set the connect option when activating the Enable batch mode button.

To select the information in the second column on the Ready screen, use the up/down arrow buttons in the "FLEXQ" box.

The choices are: Patient Last Name, Accession No. or Sampler ID.

Sample age is the time within which the sample should be analyzed. It can be defined for each measured parameter individually or for all parameters.

Patient Report Layout (described further in this chapter) offers the following time registration items in the Patient ID:

"Draw time", i.e. when the sample was obtained from the patient; is entered

•

by the operator on the Patient Identification screen on the analyzer or obtained from the RADIANCE system.

"Sample registration", i.e. when the sample was registered by the analyzer; is

• automatically registrered by the analyzer.

"Time before FLEXQ", i.e. sample transport time to the analyzer; is obtained

• if the "Draw time" has been entered; is automatically registrered by the analyzer.

"Time in the FLEXQ", i.e. waiting time; is automatically registrered by the

• analyzer.

Max. sample age (is entered on the RADIANCE system). This setting, if

• used, will overrule the settings selected on the analyzer.

The sample age is calculated, using the following:

Manual measurement "Sample age " = "Sample registration" – "Draw time".

Sample age = 0 if "Draw time" is not entered.

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FLEXQ measurement "Sample age" = "Time before FLEXQ" + "Time in

FLEXQ" where: "Time before FLEXQ" = "Sample registration" – "Draw time"; Time in FLEXQ" = "Time the sample aspiration begins" – "Sample registration"

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ABL800 FLEX Operator's Manual 3. Installation and setup

Analysis setup, Continued

Sample age (continued)

To define maximum allowed sample age, do the following:

Step Action

Activate the check button in the "Calculation of sample age" box.

To select the same age for all parameters, press Set all.

To select the sample age for each parameter individually, highlight a parameter in the "Sample aging time per parameter" box, using the up/down arrow buttons.

Select sample age for the highlighted parameter, using up/down arrow

buttons.

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3. Installation and setup ABL800 FLEX Operator's Manual

Patient reports

Purpose

This program allows you to create a number of new layouts for patient reports or to modify the existing ones.

Creating a layout

The screen accomodates two main functions: creating a layout and editing a layout.

To create a new layout, do the following:

Step Action

Press New to make a new blank layout with the name "New"

displayed on the right side of the screen in the "Name" box. If you wish to make a copy of an existing layout and use it as a basis

for a new layout, select the desired layout and press Copy. "Copy" will be added to the name in the "Name" box (i.e. "-R- default Copy").

Press the keyboard icon beside the "Name" box

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Type in a new name for your layout. Confirm with Enter to return to the Patient Report Setup screen. The newly named layout will be added to the list of layouts. Edit your layout as described in Editing a layout further in this

section.

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ABL800 FLEX Operator's Manual 3. Installation and setup

Patient reports, Continued

Creating a layout

(continued)

Editing a layout

To make the highlighted layout a default for your analyzer press Make Default. The default layout will be marked with (3) in the list of layouts.

To make a test printout of the highlighted layout (patient ID items and selected parameter groups with the parameters/units for each parameter group) press Preview. This test print will be labeled "Preview".

To reset any user defined layout to the –R- Default layout, select the desired layout and press –R– Default.

To delete a highlighted layout, press Delete. Note that the Radiometer default layout cannot be deleted. The button is disabled if only the Radiometer default layout is available.

To edit a layout, do the following:

Step Action

Highlight a layout in the list by touching it on the screen.

Press the Edit Patient ID Layout button to edit the patient ID items –

see description on the next page.

Press the Edit Patient Results Layout button to edit the parameter

groups – see description further in this section. If an automatic printout of the Acid-Base chart for this layout is

desired, activate the Print Acid-Base Chart button.

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3. Installation and setup ABL800 FLEX Operator's Manual

Patient reports, Continued

Editing patient ID layout

You can customize the patient identification (Patient ID) information as follows:

• select the items to be included in the Patient ID.

• set Patient ID entries as mandatory.

• define default values for Patient ID.

Selected patient report layout

To edit a patient ID for a selected patient report layout, do the following:

Step Action

To add a highlighted (by touching it on the screen) item in the

"Available items" box, to the list of selected items, press the “→ “ button.

To remove a highlighted (by touching it on the screen) item from the

"Selected items" box, press the “←” button. To make a highlighted item in the list of selected items mandatory,

press the Set as Mandatory button. The item will be indicated by a " on the Patient ID screen and must be entered during a measurement before a patient result can be viewed.

To remove the mandatory mark, highlight the item in the "Selected items" box and press the Set as Mandatory button again.

NOTICE: If you are using mandatory input fields, you are not allowed to change the report layout during measurement, unless the mandatory fields have been filled out.

Press Back to exit the screen.

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ABL800 FLEX Operator's Manual 3. Installation and setup

List

Patient reports, Continued

Entering default values

To enter default values for patient identification items, do the following:

Step Action

Use the arrow buttons on the right to highlight the desired item in the

"Selected items" box.

Changes to

Set the default:

If the item has a value, press Keyboard, enter the value and press

•

Enter on the keyboard to confirm.

If the item has a list of options, press List, highlight the option

•

using the arrow buttons and press Enter

to confirm.

Set or change other default val ues in the s imilar m anner. Press Back to exit and confirm changes.

NOTICES:

• It is not possible to set default values for all items.

• The values can be changed on a result-by-result basis on the Patient

Identification screen.

• An item placed in the Selected items list does not appear in the Available items list.

• To use the Patient Lookup function, Department (Pat.) should be selected for the Patient Identification screen.

• To use the Request function, Accession number, Sampler ID and/or Patient ID should be selected for the Patient Identification screen.

Continued on next page

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3. Installation and setup ABL800 FLEX Operator's Manual

Patient reports, Continued

Editing patient result layout

You can do the following:

• select parameter groups and the parameters in each group, and

• make report layout by using layout commands.

To edit a patient result layout, do the following:

Step Action

Select the patient report layout by highlighting it on the screen and

press Edit Patient Results Layout.

Use the arrow buttons to highlight a parameter group and press “→”

Include Exclude

to include the group in the patient result. It will be shown in the "Selected items" box.

Select parameters for this parameter group by highlighting them one

by one and pressing “→” (Include). Select another parameter group and parameters for this group in the

same manner.

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Use layout commands <New group> (items following this command

are placed on the top of the next half of the screen), <New Line> (a line is inserted between items) or <New Page> (items following this command appear on next screen page) as desired and press “→”.

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ABL800 FLEX Operator's Manual 3. Installation and setup

Patient reports, Continued

Editing patient result layout

(continued)

Step Action

To exclude an item from the selected parameter list, highlight it and

press “←” If you wish to display parameters with their reference ranges and have

them checked against reference ranges/critical limits, do the following:

• Highlight a parameter.

• Press Show Ranges to indicate it by “[xxx-xxx]”.

• Repeat for other parameters in the same manner.

If the “[xxx-xxx]” is not included for a parameter, checking against reference ranges/critical limits is disabled for this parameter. However, checking against the reportable ranges is always performed.

NOTICE: Refer to the Reference Manual, chapter 6: Parameters, for information on parameters and their groups.

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3. Installation and setup ABL800 FLEX Operator's Manual

Calibration setup

Programs

Calibration drift tolerances

Calibration Setup programs are described in this section.

Activate a button to enter the program.

This program allows you to change the default drift tolerances for the pH, pCO2,

, electrolyte and metabolite electrodes − see Radiometer default settings in

chapter 15 in this manual. NOTICE: Radiometer recommends the use of the default drift tolerances. Too

narrow drift tolerances will cause electrode drift errors even for normal electrode fluctuations. If the drift tolerances are made wider, no warning will be given if the electrode should become unstable. Significant measurement errors could result.

To define your own drift tolerances, do the following:

Step Action

Highlight the desired parameter by touching it on the screen.

The list of available parameters depends on your analyzer version.

Type in your own value and confirm with Enter.

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Change other drift tolerances in the same manner.

Press Close to confirm the changes.

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ABL800 FLEX Operator's Manual 3. Installation and setup

Calibration setup, Continued

Calibration schedule

This program allows you to schedule automatic calibrations, manual tHb calibration and automatic cleaning (the first automatic cleaning also includes quality control of the Crea A and B electrodes for high creatinine values on the ABL8x7 FLEX analyzers), and select a calibration to be performed after a sample measurement.

24-hour scale shows the time for each scheduled automatic calibration or cleaning.

To edit the schedule for automatic calibrations/cleaning and tHb calibration, do the following:

Step Action

Highlight the desired calibration or cleaning on the screen.

List of activities: calibrations and cleaning.

Press the Edit button.

Activity after each measurement

Use the arrow buttons to select start time for calibrations and cleaning and the intervals between each activity.

Continued on next page

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3. Installation and setup ABL800 FLEX Operator's Manual

Calibration setup, Continued

Calibration schedule

(continued)

Available calibration schedule options

Step Action

Select activity after each measurement by activating the check button

for the desired calibration.

The following options are available.

Option Interval

1 Point calibration 30 min, 1 hour, 2, or 4 hours. 2 Point calibration 1 hour, 2, 4 or 8 hours. 1 Point pH/BG calibration

30 min, 1 hour, 2 hours.

(for the USA only) tHb calibration Never, 7 days, 1 month, 2, 3, 4 or 6 months Start time 00:00, 00:15, 00:30, 00:45.……. 23:45. or

12 midnight, 12:15 am, 12:30 am, 12:45 am…….12 midday, 12:15 pm…..11:45 pm.

Activity after measurement none, 1 Point pH/BG calibration (for the USA

only), 1 Point calibration, 2 Point calibration.

Cleaning intervals 8, 24 hours.

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RADIOMETER ABL800 FLEX Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Overview

1. Introduction

Names and intended use

Limitations of use and known interfering substances

Warning/Caution and Notices

Symbols overview

Overview

2. What is what

Analyzer - front

Analyzer - rear

Measuring section

Inlet module

FLEXQ module

Thermal printer

Communication ports

Barcode reader

AutoCheck module

Screen elements

Menu structure

Analyzer status

Online aid facilities

Sample counter

Overview

3. Installation and setup

Installation

Setup menu structure

Analyzer security

Analysis setup

Patient reports

Calibration setup