RADIOMETER

ABL800 FLEX Operators Manual Edition M

Operators Manual

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Page 1

ABL800 FLEX operator’s manual

Note to users of the ABL7xx Series, ABL800 FLEX, and ABL800 BASIC analyzers

Introduction

When to activate the clot-detection feature

To activate the clot-detection feature Clot-detection process

Analyzer messages

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

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. 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

1025

Clot suspected beneath pH electrode*

The difference Remove the pH electrode and between the pH of check the measuring chamber for the rinse solution, clots: clean the measuring measured during the chamber with a cotton stick sample measurement, moistened with distilled water. and that stored after Make sure no cotton fibers are left the last calibration in the measuring chamber exceeds the Clean pH electrode maximum allowable Remembrane Ref electrode drift. Replace pH electrode This indicates the Perform a 1- or 2-point calibration presence of a clot in the measuring chamber beneath the Removal condition(s): pH electrode.  Acknowledge execution of the "Clot removal procedure"  Successful 1- or 2-point calibration

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.

* NOTICE: This is a system message.

Operator action(s)

 Perform a 1- or 2-point calibration. Removal condition(s):  Successful 1- or 2-point calibration.

Acknowledging execution of a "Clot-removal procedure"

No.

Message

Interpretation

Operator action(s)

1027

Clot suspected beneath pH electrode

The difference  Remove the pH electrode and between the pH of check the measuring chamber for the rinse solution, clots: clean the measuring measured during the chamber with a cotton stick sample measurement, moistened with distilled water. and that stored after Make sure no cotton fibers are left the last calibration in the measuring chamber exceeds the  Clean pH electrode maximum allowable  Remembrane Ref electrode drift.  Replace pH electrode This indicates the Perform a 1- or 2-point calibration presence of a clot in the measuring chamber beneath the Removal condition(s): pH electrode.  Acknowledge execution of the "Clot removal procedure"  Successful 1- or 2-point calibration

Step

Action

Press Analyzer status > Electrodes and others.

Press Replace.

Press Clots removed.

Technical documentation

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

Instructions to user

Please place this document in the binder of your manual.

Note to the users of the EML105, ABL5xx, ABL SYSTEM 6xx, ABL7xx Series, ABL800 FLEX and ABL800 BASIC analyzers Introduction

This note to users outlines a change in the operator’s and reference manual for your EML105, ABL5xx, ABL SYSTEM 6xx, ABL7xx Series, and/or ABL800 FLEX and ABL800 BASIC analyzer.

Brief overview of the change

Operator’s manual: 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) has been detected: cCa2+ (1.25 mmol/L level): 0.20*.

* Depending on the pH level

Reference manual: Change/Description Interference on

–

For ClO4 , interference on cCa2+ (1.25 mmol/L level) has been detected. The interference results for ClO4– are as follows: Interference on…

Substance ClO4– 1.5

Test Conc.

mmol/L

cK+

cNa+

cCa2+

cCl

(4 mmol/L level)

(150 mmol/L level)

(1.25 mmol/L level)

(110 mmol/L level)

0.20*

8-30

* Depending on the pH level A "-" indicates that interference has not been measured on the respective parameter.

Technical documentation

The manual will be updated with the above information as part of the next manual update.

Instructions to user

Please place this note to the users in the binder of your manual.

Table of contents

ABL800 FLEX

Operator’s manual

Introduction

What is what

Installation and setup

Sample measurements

Quality control

Calibration

Replacements

Disk functions

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, including that only accessories meeting the specifications provided by Radiometer are used. Radiometer disclaims any liability for system performance if the system is not installed, used and maintained in accordance with Radiometer procedures or if accessories not meeting the specifications provided by Radiometer are used. Further, Radiometer disclaims any liability for loss of data and direct, consequential or other damages, including loss of profit or loss of business, whether such claim for damages is based upon contract, negligence or tort (including strict liability), and even if Radiometer has knowledge of the possibility of the potential damage or loss.

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

Changes This document is subject to change without notice and you are urged to contact Radiometer to verify whether the document has been changed. While every effort is made to ensure the correctness of the information provided in this document as changed from time to time, Radiometer disclaims any liability for errors and omissions.

End-User License Agreement for the ABL800 FLEX Analyzers T

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. Contents ... 1 TU

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 Notes ... 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 Parameters and input setup ...3-55 Analyzer settings ...3-62 Communications ...3-68 Printers ...3-77

Contents

ABL800 FLEX Operator's Manual

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 an expired air sample ...4-15 Patient identification...4-16 Patient result...4-20

Calculation of FShunt and ctO2(a - V ) ...4-24 B

Patient result messages ...4-25 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 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

ABL800 FLEX Operator's Manual

Contents

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 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

Contents

ABL800 FLEX Operator's Manual

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 ... 12-14 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 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 T

Date of Issue T

1. Introduction Overview Introduction

The chapter briefly describes the intended use of the analyzer, lists all measured parameters and the substances known to interfere with the measurements, and explains the different notices that appear in the manual. Throughout this manual, "ABL800 FLEX analyzer" is used for all ABL8xx FLEX analyzers, i.e.: ABL837/835/830/827/825/820/817/815/810/805 and ABL810 BG only. The abbreviation "ABL8x7 FLEX analyzer" is used for the ABL837/27/17 FLEX analyzers throughout this manual.

Contents

This chapter contains the following topics. Names and intended use...

1-2

Limitations of use and known interfering substances ...

1-4

Warning/Caution and Notes...

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, pO2, pCO2, cK+, cNa+, cCa2+, cCl–, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) in vitro testing of samples of expired air for the parameters pO2 and pCO2

The following parameters can be measured on blood: Parameter group pH/blood gas:

Parameters pH (acidity) pCO2 (carbon dioxide tension) pO2 (oxygen tension)

Oximetry:

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

Electrolytes:

cK+ (potassium ion concentration) cNa+ (sodium ion concentration) cCa2+ (calcium ion concentration) cCl– (chloride ion concentration)

Metabolites:

cGlu (D-glucose concentration) cLac (L(+)-lactate concentration) 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

1-2

ABL800 FLEX Operator's Manual

1. Introduction

Names and intended use, Continued Intended use (continued)

The following parameters can be measured on expired air samples: Parameter group Measured values

Parameters pCO2 (carbon dioxide tension) pO2 (oxygen tension)

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

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

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

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.

Other fluids mode

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

FLEXQ module 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). NOTE:

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

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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. WARNING/CAUTIONs: • The user should review the analyzer performance data to assure that the performance fulfills the user-specific analytical needs. • 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. • 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. • WARNING - 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. 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 %).

Known interfering substances

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 (medication)

In OXI measurements.

Anions: Br − , I − , S 2− and ClO 4− (drugs)

Erroneously high cCl- results.

Continued on next page

1-4

ABL800 FLEX Operator's Manual

1. Introduction

Limitations of use and known interfering substances, Continued

Known interfering substances (continued)

Substance

Anticoagulants (sampling)

Interference

Anticoagulants that contain sodium salts will give erroneously high cNa+ results. Sodium fluoride with or without EDTA and oxalate (di Na) influence cGlu results. Sodium fluoride gives erroneously high cNa+ and low cCa2+, cGlu and cLac results. Tri sodium citrate influences cNa+, cK+ and cGlu results. Thus Radiometer recommends the exclusive use of heparin as anticoagulant. Solutions containing organic preservatives may damage the ion-selective membranes of the cK+ and cGlu electrodes when introduced into the analyzer. Do not use EDTA, as it leads to erroneous pH, pCO2, cNa+, cK+ and cCa2+ results. Use of EDTA will also affect subsequent measurements on the cCa2+ electrode and it will reduce the lifetime of this electrode.

Erroneously high cGlu and cLac Thiocyanic acid (degradation product from treatment with measurements. nitroprussid. Also produced in thiosulphate treatment of cyanide poisoning) Glycolic acid (ethyleneglycol degradation product)

Erroneously high cLac measurements.

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.

Other fluids mode allows you to measure on fluids other than heparinized human blood. WARNING/CAUTION: 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

Known interfering substances (continued)

Substance

Interference

Carboxymethyl cellulose (CMC) Some auto-venting arterial blood samplers contain carboxymethyl cellulose (CMC) in the porous vent. CMC can dissolve into the sample and give erroneously low cCa2+ 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, Erroneously high cGlu measurements. mannose, xylose

For detailed information – see Interference Tests in chapter 5 of the ABL800 FLEX Reference Manual.

1-6

ABL800 FLEX Operator's Manual

1. Introduction

Warning/Caution and Notes 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 NOTES. The following table indicates the type of information given in Warnings, cautions and notes. Notice

WARNING/ CAUTION

Definition

WARNING

Warning alerts users to potential serious outcomes to themselves or the patient (such as death, injury or serious adverse events).

CAUTION

Caution alerts users to exercise special care necessary for the safe and effective use of the device. Caution may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury, but about which the user should be aware. Caution may also alert users to adverse effects on the device by use or misuse, and the care necessary to avoid such effects.

NOTE

Notes give practical information.

In this manual a distinction between a warning and a caution is not made. Any notice that alerts the user to possible dangers of any kind is given the title WARNING/CAUTION.

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