RADIOMETER

ABL80 FLEX Operators Manual Edition K

Operators Manual

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ABL80 FLEX operator's manual

Operator’s manual Note to users of the ABL80 FLEX analyzer Introduction

This note to users describes the linearity specifications for glucose as it relates to the pO2 level. The linearity of the glucose is dependent on the oxygen tension of the sample. This dependence is due to the co-reaction of glucose and oxygen by the enzyme glucose oxidase. Low pO2 levels can influence the linearity of the glucose sensor. The following table outlines the glucose linearity as a function of the pO2.

Instructions to user

Please place this document in the binder of your manual.

Brief Overview of the changes

Changes / Description To increase operator awareness, the specifications listed here regarding glucose linearity in the ABL80 FLEX analyzer will be added to the operator’s manual. This information is already provided in the ABL80 FLEX Reference Manual, chapter 6. Specification

CAUTION: Low pO2 levels can influence the linearity of glucose measurements, and can therefore result in falsely low glucose results. Please note that glucose performance is not specified when the pO2 is less than 20 mmHg (2.7 kPa). Impact of the pO2 level on Glucose linearity

If the pO2 level in a sample is:

Technical documentation

Then cGlu linearity

specifications only apply to cGlu values between:

<20 mmHg

Linearity not specified. Interpret all results with caution.

20-40 mmHg

0-10 mmol/L

40-90 mmHg

0-25 mmol/L

≥90 mmHg

0-40 mmol/L

Information in this document will be added to the operator’s manual in an upcoming version.

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

Table of Contents

ABL80 FLEX analyzer

Operator’s manual

Introduction

What is what

General software features

Sample measurements

Calibration

Quality Control

Data

Utilities

Settings

10.

Troubleshooting

11.

Sampling

12.

Specifications

13.

Order information

Index

Date of Issue

SYSTEM PERFORMANCE The procedures described in this manual must be observed in order to ensure proper system performance, and to avoid hazards. Radiometer cannot provide or verify system performance characteristics if the system is not installed, used and maintained in accordance with Radiometer procedures or if accessories not meeting the specifications provided by Radiometer are used. Radiometer warrants that the data media on which the software included in the system is furnished is free from defects in material and workmanship under normal use for three (3) months from the date of delivery as evidenced by a copy of invoice or receipt.

THIRD-PARTY SOFTWARE AND TRADEMARKS The ABL80 FLEX analyzer system comprises the Microsoft® Windows® XP Embedded Operating System. By using the system, you accept the terms of the Software License Agreement(s) of the provider(s) of the above software as shown in the End User License Agreement(s) included in this manual. If you cannot accept the terms of the Software License Agreement(s), you should not use the system, but immediately contact your provider for a return of the system and a refund of the purchase price. Microsoft® and Windows® are trademarks of Microsoft Corporation.

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 •

You have acquired a device (ABL80 FLEX analyzer) that includes software licensed by SenDx Medical, Inc., A Radiometer Company (RADIOMETER) from Microsoft Licensing Inc. or its affiliates (MS). Those installed software products of MS origin, as well as associated media, printer 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 RADIOMETER FOR INSTRUCTIONS ON RETURN OF THE UNUSED DEVICE(S) FOR A REFUND. ANY USE OF THE SOFTWARE, INCLUDING BUT NOT LIMITED TO USE ON THE DEVICE, WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA (OR RATIFICATION OF ANY PREVIOUS CONSENT).

•

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



You may use the SOFTWARE only on the ABL80 FLEX analyzer.



NOT FAULT TOLERANT. THE SOFTWARE IS NOT FAULT TOLERANT. RADIOMETER HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE, AND MS HAS RELIED UPON RADIOMETER 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, THESE WARRANTIES DO NOT ORIGINATE FROM, AND ARE NOT BINDING ON, MS.



Note on Java Support. The SOFTWARE may contain support 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 technology could lead directly to death, personal injury or severe physical or environmental damage. Sun Microsystems, Inc. has contractually obligated MS to make this disclaimer.



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



Limitations on Reverse Engineering, Decompilation and Disassembly. You may not reverse engineer, 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 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 U.S. Export Administration Regulations, as well as end-user, end-use and country destination restrictions issued by U.S. and other governments. For additional information on exporting the SOFTWARE, see http://www.microsoft.com/exporting/.

FONT SOFTWARE END-USER LICENSE AGREEMENT The Font Software, which has been developed and licensed by Agfa Monotype Corporation under License Number: 103020067, is for use with the ABL80 FLEX analyzer instrument only. The Font Software is embedded in the proprietary software developed by SenDx. You may not extract, decompile, reverse engineer, disassemble or modify the Font Software in any way. The Font Software may not be removed from the instrument. This EULA does not transfer any right, title or interest in the SenDx Product to you except as specifically set forth herein. You are on notice that SenDx claims protection of this software product under copyright laws. The SenDx Product may have been developed by an independent third party software supplier, which holds copyright or other proprietary rights to its software product. You may be held responsible by this supplier for any infringement of such rights by you. If this instrument is acquired under the terms of a (i) GSA contract - use, reproduction or disclosure is subject to the restrictions set forth in the applicable ADP Schedule contract, (ii) DOD contract - use, duplication or disclosure by the Government is subject to restrictions set forth in subparagraph (c)(1)(ii) of 252.277-7013; (iii) Civilian agency contract - use, reproduction, or disclosure is subject to 52.277-19(a) through (d) and restrictions set forth in the accompanying End User Agreement. All rights reserved under the copyright laws of the United States. Agfa Monotype Corporation, 985 Busse Road, Elk Grove Village, Illinois 60007-2400 U.S.A. If you do not agree with the above terms and conditions, you should promptly contact your Radiometer representative and return the ABL80 FLEX analyzer instrument. ANY USE OF THE SOFTWARE, INCLUDING BUT NOT LIMITED TO USE OF THE INSTRUMENT, WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA (OR RATIFICATION OF ANY PREVIOUS CONSENT).

Table of contents Introduction

This manual describes how to operate all versions of the ABL80 FLEX analyzer.

Contents

This manual contains the following topics.

1. Introduction ... 1-1 Intended use ... 1-2 Known interfering substances... 1-9 Warnings and cautions ... 1-10 Limitations of use ... 1-11 2. What is what ... 2-1 Analyzer front view – ABL80 FLEX analyzer ... 2-2 Analyzer front view – ABL80 FLEX CO-OX analyzer ... 2-3 Analyzer rear view... 2-4 Solution pack ... 2-5 Sensor cassette front and rear views ... 2-8 Analyzer power... 2-13 Installing consumables... 2-15 3. General software features ... 3-1 Touch screen ... 3-2 Main menu ... 3-3 Analyzer status... 3-5 Tutorials ... 3-8 Icons... 3-10 4. Sample measurements ... 4-1 General information ... 4-2 Introducing a blood sample ... 4-3 Sample information ... 4-15 Patient report... 4-20 Edit patient information ... 4-21 Patient edit log ... 4-24 Approval ... 4-25 FlexLink... 4-27

Table of contents

ABL80 FLEX operator’s manual

5. Calibration ... 5-1 General information ... 5-2 Calibration reports ... 5-4 tHb calibration ... 5-6 Standby mode ... 5-9 6. Quality management ... 6-1 Automatic quality control ... 6-2 System Checks ... 6-6 Analysis Check ... 6-7 Manual quality control ... 6-8 Preparing manual QC solutions ... 6-9 Performing a manual QC measurement ... 6-10 Manual QC results ... 6-15 Out of range manual QC results ... 6-16 Manual QC plot ... 6-17 Reviewing manual QC statistics ... 6-19 Range+ QUALICHECK QC solution... 6-20 RiliBÄK ranges ... 6-22 7. Data logs ... 7-1 General information ... 7-2 Logs ... 7-4 Upload ... 7-5 Download... 7-8 Data maintenance... 7-11 System information... 7-13 8. Utilities... 8-1 Installation – sensor cassette ... 8-2 Installation – solution pack ... 8-5 Counter ... 8-7 Settings transfer ... 8-9 tHb calibration ... 8-11 Rinse ... 8-12 Software upgrade ... 8-13 Eject CD ... 8-14

ABL80 FLEX operator’s manual

Table of contents

9. Settings ... 9-1 Patient ranges ... 9-2 Manual QC... 9-7 Manual QC ranges ... 9-8 Manual QC lockout... 9-11 Manual QC statistical factor ... 9-13 Manual QC schedule... 9-14 Manual QC temperature ... 9-17 RiliBÄK ranges ... 9-19 System Cycle schedule ... 9-21 System Cycle drift ... 9-22 Standby schedule ... 9-23 tHb calibration schedule ... 9-25 Date/time... 9-26 Units... 9-27 Data communications ... 9-29 FlexLink... 9-39 Analyzer message ... 9-41 System status ... 9-42 Correlation ... 9-44 Record deletion ... 9-48 Main menu setup... 9-49 Reports ... 9-52 Reports – input fields ... 9-53 Reports – printout ... 9-59 Reports – patient download ... 9-69 System – active parameters ... 9-70 System – air detection... 9-73 System – analyzer lockout ... 9-75 Security ... 9-76 10. Troubleshooting ... 10-1 General information ... 10-2

Warnings and cautions ... 10-3 Guidelines ... 10-4 Normal fluidics – ABL80 FLEX analyzer ... 10-5 Normal fluidics – ABL80 FLEX CO-OX analyzer ... 10-8 Analyzer cleaning and disinfection... 10-10 Disinfection procedure... 10-12

iii

Table of contents

ABL80 FLEX operator’s manual

System Cycle unsuccessful ... 10-13

General information – sensor cassette ... 10-14 Single versus multiple parameters ... 10-15 Single parameter out of range – sensor cassette ... 10-20 Multiple parameters out of range – sensor cassette ... 10-22 Possible sources of air contamination... 10-23 CO-oximeter troubleshooting ... 10-26 Manual QC results out of range ... 10-28 System messages ... 10-30

General error messages ... 10-33 CO-OX error codes ... 10-55 Result messages ... 10-61 Battery management ... 10-65

11. Sampling ... 11-1 Causes of errors in the preanalytical phase ... 11-2 Preparation prior to arterial/venous sampling ... 11-4 Preparation prior to capillary sampling ... 11-6 Sampling devices ... 11-7 CLINITUBES - ABL80 FLEX analyzer ... 11-8 Storage and preparation prior to analysis ... 11-9 Sampling procedures ... 11-11 References... 11-12 12. Specifications ... 12-1 Measured parameters ... 12-2 Calculated parameters ... 12-4 Input parameters ... 12-7 Physical and operating specifications ... 12-8 Approvals and compliances ... 12-11 Symbols list ... 12-13 Patents ... 12-15 13. Order information ... 13-1 ABL80 FLEX analyzer ... 13-2 ABL80 FLEX CO-OX analyzer ... 13-5 Accessories ... 13-7 Documentation... 13-9 Samplers ... 13-11 Index Date of Issue

1. Introduction Introduction

This chapter provides an introduction to all versions of the ABL80 FLEX analyzer. It describes the usage of the analyzer, lists all possible measured and calculated parameters, and lists substances known to interfere with the measurements. An explanation of the use of warnings and cautions is also included. This manual provides information for both the ABL80 FLEX and the ABL80 FLEX CO-OX analyzers. Features that apply to both analyzers are described only once. Features that differ between the two analyzers are clearly noted within the text of this manual. The ABL80 FLEX analyzer is available in two software configurations: FLEX and BASIC. Features that apply to both software configurations are described only once. Features that differ between the two software configurations are clearly noted within the text of this manual. The ABL80 FLEX CO-OX analyzer is available in two software configurations: CO-OX and OSM. Features that apply to both software configurations are described only once. Features that differ between the two software configurations are clearly noted within the text of this manual.

In this chapter

This chapter covers the following topics: Intended use ... 1-2 Known interfering substances ... 1-10 Warnings and cautions ... 1-11 Limitations of use... 1-12

1. Introduction

ABL80 FLEX Operator's Manual

Intended use Intended use

The ABL80 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, hematocrit (ABL80 FLEX analyzer only) and oximetry (ABL80 FLEX CO-OX analyzer only) in whole blood. The ABL80 FLEX analyzer system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

WARNING:

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

Human blood

All ABL80 FLEX analyzer versions are designed for use with undiluted human arterial, venous, and capillary whole blood. The ABL80 FLEX analyzer (both software configurations) requires a minimum sample volume of 70 µL. The ABL80 FLEX CO-OX analyzer with CO-OX software configuration requires a minimum sample volume of 105 µL. The ABL80 FLEX CO-OX analyzer with OSM software configuration requires a minimum sample volume of 65 µL.

Animal blood

Animal blood has not been tested using the ABL80 FLEX analyzers. Some components in animal blood differ from those in human blood. Variations in the composition of blood from different animal species may also exist.

Measured parameters,

The following parameters can be measured in blood:

ABL80 FLEX analyzer

1-2

Parameter Symbol

Description

ABL80 FLEX Configuration FLEX

BASIC

Acidity or alkalinity

pCO2

Carbon dioxide tension

pO2

Oxygen tension

cCa2+

Calcium ion concentration

cK+

Potassium ion concentration

cNa+

Sodium ion concentration

cCl–

Chloride ion concentration.

cGlu

Glucose concentration (Dglucose)

Hct

Volume fraction of erythrocytes in blood (hematocrit)

ABL80 FLEX Operator's Manual

Measured parameters, ABL80 FLEX CO-OX analyzer

1. Introduction

The following parameters can be measured in blood: Parameter Symbol

Description

ABL80 FLEX CO-OX Configuration CO-OX

Acidity or alkalinity

pCO2

Carbon dioxide tension

pO2

Oxygen tension

cCa2+

Calcium ion concentration

OSM

Potassium ion concentration

Sodium ion concentration

–

Chloride ion concentration.

cGlu

Glucose concentration (Dglucose)

ctHb

Concentration of total hemoglobin

sO2

Oxygen saturation

FO2Hb

Fraction of oxygenated hemoglobin in total hemoglobin

FCOHb

Fraction of carboxyhemoglobin in total hemoglobin

FMetHb

Fraction of methemoglobin in total hemoglobin

FHHb

Fraction of deoxyhemoglobin in total hemoglobin

cNa cCl

1-3

1. Introduction

Derived parameters, ABL80 FLEX analyzer

ABL80 FLEX Operator's Manual

The following parameters are derived: Parameter Symbol

–

1-4

Description

ABL80 FLEX Configuration FLEX

BASIC

cHCO3 (P)

Concentration of hydrogen carbonate ion (bicarbonate) in plasma

cBase(B)

Concentration of actual titratable base in blood (actual base excess)

cBase(Ecf)

Concentration of standard titratable base in blood (standard base excess)

cBase(B,ox)

Concentration of actual titratable base in fully oxygenated blood

cBase(Ecf,ox) Concentration of standard titratable base in fully oxygenated blood

ctCO2(B)

Concentration of total carbon dioxide in blood (CO2 content)

ctCO2(P)

Concentration of total carbon dioxide in plasma (CO2 content)

cHCO3–(P,st)

Concentration of hydrogen carbonate ion (bicarbonate) in plasma of standardized blood (standard bicarbonate)

ctHb

Concentration of total hemoglobin in blood

cCa2+(7.4)

Concentration of ionized calcium in plasma at a pH of 7.40

Anion Gap (K+)

Concentration difference between (K+ + Na+) and (Cl– + HCO3–)

Anion Gap

Concentration difference between Na+ and (Cl– + HCO3–)

ABL80 FLEX Operator's Manual

Parameter Symbol

1. Introduction

Description

ABL80 FLEX Configuration FLEX

BASIC

ctO2

Concentration of total oxygen in blood (O2 content)

sO2

Oxygen saturation of hemoglobin in blood. It is the ratio between the concentration of O2Hb and HHb + O2Hb. The sum does not include dyshemoglobins like COHb and MetHb. Sometimes named “functional saturation”.

pO2(A)

Oxygen tension in alveolar air

pO2(A-a)

Alveolo-arterial oxygen tension difference

pO2(a/A)

Arterio-alveolar oxygen tension ratio

R/I

Respiratory index; the ratio between the oxygen tension difference of alveolar air and arterial blood and the oxygen tension of arterial blood

pH (T)

pH at patient temperature

pCO2 (T)

Carbon dioxide tension in blood at patient temperature

pO2 (T)

Oxygen tension in blood at patient temperature

pO2(A, T)

Oxygen tension in alveolar air at patient temperature

pO2(A-a, T)

Alveolo-arterial oxygen tension difference at patient temperature

pO2(a/A, T)

Arterio-alveolar oxygen tension ratio at patient temperature

R/I (T)

Respiratory index at patient temperature

mOsm

Osmolality

1-5

1. Introduction

Derived parameters, ABL80 FLEX CO-OX analyzer

1-6

ABL80 FLEX Operator's Manual

The following parameters are derived: Parameter Symbol

Description

ABL80 FLEX CO-OX Configuration CO-OX

cHCO3–(P)

Concentration of hydrogen carbonate ion (bicarbonate) in plasma

cBase(B)

Concentration of actual titratable base in blood (actual base excess)

cBase(Ecf)

Concentration of standard titratable base in blood (standard base excess)

cBase(B,ox)

Concentration of actual titratable base in fully oxygenated blood

cBase(Ecf,ox)

Concentration of standard titratable base in fully oxygenated blood

ctCO2(B)

Concentration of total carbon dioxide in blood (CO2 content)

ctCO2(P)

Concentration of total carbon dioxide in plasma (CO2 content)

cHCO3–(P,st)

Concentration of hydrogen carbonate ion (bicarbonate) in plasma of standardized blood (standard bicarbonate)

cCa2+(7.4)

Concentration of ionized calcium in plasma at a pH of 7.40

Anion Gap (K+)

Concentration difference between (K+ + Na+) and (Cl– + HCO3–)

Anion Gap

Concentration difference between Na+ and (Cl– + HCO3–)

OSM

ABL80 FLEX Operator's Manual

Parameter Symbol

1. Introduction

Description

ABL80 FLEX CO-OX Configuration CO-OX

OSM X

ctO2

Concentration of total oxygen in blood (O2 content)

pO2(A)

Oxygen tension in alveolar air

pO2(A-a)

Alveolo-arterial oxygen tension difference

pO2(a/A)

Arterio-alveolar oxygen tension ratio

R/I

Respiratory index; the ratio between the oxygen tension difference of alveolar air and arterial blood and the oxygen tension of arterial blood

pH (T)

pH at patient temperature

pCO2 (T)

Carbon dioxide tension in blood at patient temperature

pO2 (T)

Oxygen tension in blood at patient temperature

pO2(A, T)

Oxygen tension in alveolar air at patient temperature

pO2(A-a, T)

Alveolo-arterial oxygen tension difference at patient temperature

pO2(a/A, T)

Arterio-alveolar oxygen tension ratio at patient temperature

R/I (T)

Respiratory index at patient temperature

mOsm

Osmolality

Hct

Volume fraction of erythrocytes in blood (hematocrit)

1-7

1. Introduction

ABL80 FLEX Operator's Manual

Parameter Symbol

Description

ABL80 FLEX CO-OX Configuration CO-OX

1-8

P50

Partial pressure of oxygen at which the blood is 50% saturated

P50(T)

Partial pressure of oxygen, at patient temperature, at which the blood is 50% saturated

p50(st)

Partial pressure of oxygen at which the blood is 50% saturated at standard conditions

pO2(a)/FO2(I)

Partial pressure of oxygen as a ratio of the fraction of inspired oxygen

pO2(a,T)/FO2(I)

Partial pressure of oxygen, at patient temperature, as a ratio of the fraction of inspired oxygen

pO2(x)

Partial pressure of the oxygen extraction of arterial blood

pO2(x,T)

Partial pressure of the oxygen extraction of arterial blood, at patient temperature

BO2

Hemoglobin oxygen capacity; the maximum concentration of oxygen bound to hemoglobin in saturated blood, such that all deoxyhemoglobin is converted to oxyhemoglobin

· DO2

Oxygen delivery; the total amount of oxygen delivered to the whole organism per unit of time

OSM

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