ABL800 FLEX operators manual

ABL800 FLEX operators manual

Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, PICO and CLINITUBES are trademarks of Radiometer Medical ApS. 2011 Radiometer Medical ApS. All rights reserved. 995-922. 201104A.

Note to users of the ABL800 FLEX analyzers

This note to users gathers changes from previous note to users in one document and outlines some new changes to the operators manual of your ABL800 FLEX analyzer (from software version 6.10). Please remove the existing note to users from the binder of your manual and place this note to users in the binder instead.

Changes/Description

Limitations of use and known interfering substances:

CAUTION - Known interfering substances

Substance Interference

ClO4 (drugs) For ClO4 , interference on cCa2+ (1.25 mmol/L level), cCl (110 mmol/L level), and cK+ (4 mmol/L level) has been detected: cCa2+ (1.25 mmol/L level): 0.27* cCl (110 mmol/L level): 4-30 cK+ (4 mmol/L level): 0.3.

Interference new interference results for ClO4

* Depending on the pH level

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

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

Introduction

Instructions to user

Brief overview of the change

USB connector or CD-ROM drive

Measured parameters

New table for pleural liquid:

Parameter Unit Measuring Range

Test range

pH pH scale 6.300-8.000 7.0-7.5*

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

Indoor use statement added according to CSA regulations: Environmental requirements

Location Indoor use only

Environmental ratings

Pollution degree 2 statement added according to CSA regulations:

Installation category II.

Pollution degree 2.

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

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

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

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

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

To activate the clot-detection feature

Contact a Radiometer representative and request that clot detection be enabled via the service program. Clot-detection process During calibration the measuring chamber is rinsed and the pH of the Rinse solution is measured. The value is stored in the analyzer. During a sample measurement the measuring chamber is also rinsed and the pH of the rinse solution is measured and compared with the pH value stored during the last calibration. If the difference between these values (the pH drift) exceeds a pre-determined maximum value, it could indicate the presence of a clot beneath the pH electrode.

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

Analyzer messages

NOTICE: Operator actions are listed in order of priority. Perform the first action in the list and the actions indicated in the "Removal condition(s) list. If the message persists, perform the next listed action and the actions indicated in the "Removal condition(s) list, and so on.

No. Message Interpretation Operator action(s)

Clot suspected beneath pH electrode*

The difference between the pH of the rinse solution, measured during the sample measurement, and that stored after the last calibration exceeds the maximum allowable drift. This indicates the presence of a clot in the measuring chamber beneath the pH electrode.

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

Clean pH electrode Remembrane Ref electrode Replace pH electrode Perform a 1- or 2-point calibration Removal condition(s): Acknowledge execution of the

"Clot removal procedure" Successful 1- or 2-point

calibration

1025

* NOTICE: This is a system message.

1026 Clot (pH) detection not possible

The pH of the rinse solution - stored during the latest calibration - was invalidated when either the Rinse solution was replaced, or when maintenance was performed on an electrode. A new pH value needs to be established by performing a calibration.

Perform a 1- or 2-point calibration.

Removal condition(s): Successful 1- or 2-point

calibration.

1027 Clot suspected beneath pH electrode

The difference between the pH of the rinse solution, measured during the sample measurement, and that stored after the last calibration exceeds the maximum allowable drift. This indicates the presence of a clot in the measuring chamber beneath the pH electrode.

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

Clean pH electrode Remembrane Ref electrode Replace pH electrode Perform a 1- or 2-point calibration Removal condition(s): Acknowledge execution of the

"Clot removal procedure" Successful 1- or 2-point

calibration

Step Action

1. Press Analyzer status > Electrodes and others.

2. Press Replace.

Acknowledging execution of a "Clot-removal procedure"

3. Press Clots removed.

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

Radiometer Medical ApS kandevej 21 2700 Brnshj Denmark www.radiometer.com

Technical documentation

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

ABL800 FLEX

Operators manual

System performance

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

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

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

Third-party software and trademarks

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

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

Microsoft and Windows are trademarks of Microsoft Corporation.

VxWorks is a registered trademark of WindRiver Systems Incorporated.

Sybase SQL Anywhere is a registered trademark of Sybase Incorporated.

Warranties and disclaimer

Radiometer makes no warranties, express or implied, other than expressly stated.

Any warranties expressly stated in this document are conditional upon the system being installed, used and maintained in accordance with Radiometer procedures, including that only accessories meeting the specifications provided by Radiometer are used.

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

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

Confidentiality

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

Changes

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

While every effort is