RADIOMETER
ABL80 FLEX Operators Manual Sw Ver 3.18 Edition H July 2018
Operators Manual
350 Pages
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Page 1
ABL80 FLEX operator's manual
ABL80 FLEX operator's manual
What is new in this manual? This manual has been updated with information on the following: Update for ABL80 FLEX • EAC mark and other new symbols and ABL80 • Firewall reactivation FLEX CO-OX analyzers • Preliminary values for sample measurements no longer displayed
Operator’s manual Note to the operators of the ABL80 FLEX analyzers Introduction
This Note to operators includes new information on the following: • Safety compliance and EMC compliance • Class 1 laser specification • New approver • Obsolete products • EAC mark and other new symbols • Firewall reactivation • Preliminary values for sample measurements no longer displayed
Instructions to users about this document
Replace the original date-of-issue page, the original front page and the original Note to operators (996-950) in your binder with the corresponding pages in this document.
Radiometer Medical ApS Åkandevej 21 2700 Brønshøj Denmark www.radiometer.com
©2018 Radiometer Medical ApS. All Rights Reserved. 996-950. 201807C.
Safety compliance and EMC compliance
The ABL80 FLEX analyzer meets all requirements for IEC 61010-1:2010 ed. 3, CAN/CSA C22.2 No. 61010, and EN61326:2013.
Laser specification
To be included under the Physical and operating specifications section in Chapter 12, Specifications:
Safety and EMC compliance is located under Approvals and compliances in Chapter 12, Specifications.
Laser specifications
The analyzer contains 1 laser that is in compliance with international standard (IEC 60825-1 Safety of laser products) and US requirements (21 CFR 1040.10 – LASER PRODUCTS).
New approver
Nemko replaces ETL, Inc. as approver in the Approvals and compliance section of Chapter 12, Specifications.
Obsolete products
The following products, listed under Chapter 13, Order information, are now obsolete and cannot be ordered: Accessories – ABL80 FLEX analyzer Item Sensor cassette
200 tests / 30 days
REF Full panel
QC3
945-667
3
Sensor cassette
300 tests / 15 days
Full panel
QC
945-669
Sensor cassette
300 tests / 15 days
BG/Hct
QC3
945-679
Sensor cassette
300 tests / 15 days
Full panel
no QC3
945-684
3
945-692
Sensor cassette
200 tests / 30 days
BG/Hct
no QC
Accessories – ABL80 FLEX analyzer with BASIC software configuration Item
REF
Sensor cassette
300 tests / 30 days
BG/Hct
945-789
Sensor cassette
300 tests / 15 days
BG/Hct
945-790
Accessories – ABL80 FLEX CO-OX analyzer Item Sensor cassette
300 tests / 15 days
Full panel CO-OX
REF QC3
945-705
3
Sensor cassette
300 tests / 15 days
Full panel, CO-OX no Glu
QC
945-711
Sensor cassette
300 tests / 30 days
BG/CO-OX
QC3
945-716
Sensor cassette
300 tests / 15 days
BG/CO-OX
QC3
945-717
Sensor cassette
300 tests / 15 days
Full panel CO-OX
no QC3
945-723
Sensor cassette
300 tests / 30 days
BG/CO-OX
no QC3
945-734
BG/CO-OX
3
945-735
Sensor cassette
300 tests / 15 days
no QC
EAC mark and other new symbols
The following symbols are added to the Symbols list in Chapter 12, Specifications. SYMBOL
FUNCTION EurAsian Conformity mark (EAC) is a certification mark to indicate that the products meet all requirements of the corresponding technical regulations of the Eurasian Customs Union. Manufacturer
Date of manufacture
Electrical safety mark certified by Nemko
Biological risks
Firewall reactivation
By default the Windows Firewall is enabled. The firewall is an important cybersecurity protection that should always be enabled. The analyzer verifies that the firewall is enabled each time the analyzer is powered on. If the firewall becomes disabled, the analyzer will reactivate it during the power on. If the analyzer is unable to reactivate the firewall, a yellow status light will appear on the main menu along with the status message “Unable to reactivate Windows Firewall”. Messages related to the Firewall reactivation
Preliminary values for sample measurements no longer displayed
Firewall reactivated
Windows Firewall automatically reactivated.
No action required. For information only.
Unable to reactivate Windows Firewall.
Windows Firewall cannot be automatically reactivated.
Contact Radiometer service representative.
During the second half of sample measurement, preliminary values used to be displayed for trending purposes until the final results were displayed on the screen. With software 3.18, this feature is no longer available. Now only the final results will be displayed on the screen.
Table of Contents
ABL80 FLEX analyzer
Operator’s manual
1.
Introduction
2.
What is what
3.
General software features
4.
Sample measurements
5.
Calibration
6.
Quality Control
7.
Data
8.
Utilities
9.
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 Use of this Radiometer product is subject to the terms and conditions of the accompanying End User License Terms of Microsoft®. This software is provided only for use with, and for licensed End Users of, the ABL80 FLEX analyzer. Any other use of this software is strictly prohibited and may subject you to legal action. Microsoft® is the trademark 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. 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, AQURE, PICO, CLINITUBES and QUALICHECK are trademarks of or used under license by Radiometer Medical ApS. © 2018 Radiometer Medical ApS. All rights reserved.
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 ABL80 FLEX analyzer description ... 1-2 Known interfering substances... 1-10 Warnings and cautions ... 1-11 Limitations of use ... 1-12 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 Failure report ... 3-10 Icons... 3-13 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 5. Calibration ... 5-1 General information ... 5-2 Calibration reports ... 5-4
Table of contents
ABL80 FLEX operator’s manual
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 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
ABL80 FLEX operator’s manual
Table of contents
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 – report options... 9-59 Reports – patient download ... 9-61 System – active parameters ... 9-62 System – air detection... 9-65 System – analyzer lockout ... 9-67 Security ... 9-68 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 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 ... 10-53 Result messages ... 10-58
iii
Table of contents
ABL80 FLEX operator’s manual
Battery management ... 10-62
11. Sampling ... 11-1 Causes of errors in the preanalytical phase ... 11-2 Preparation prior to arterial/venous sampling ... 11-5 Preparation prior to capillary sampling ... 11-7 Sampling devices ... 11-8 CLINITUBES - ABL80 FLEX analyzer ... 11-9 Storage and preparation prior to analysis ... 11-10 Sampling procedures ... 11-12 References... 11-13 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 ... 13-4 Accessories ... 13-6 Documentation... 13-8 Samplers ... 13-9 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, lactate, 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 whole blood. The ABL80 FLEX analyzer (both software configurations) requires a minimum sample volume of 70 µL. The ABL80 FLEX CO-OX analyzer with COOX 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
pH
Acidity or alkalinity
X
X
pCO2
Carbon dioxide tension
X
X
pO2
Oxygen tension
X
X
cCa2+
Calcium ion concentration
X
X
cK+
Potassium ion concentration
X
X
cNa+
Sodium ion concentration
X
X
cCl–
Chloride ion concentration.
X
X
cGlu
Glucose concentration (Dglucose)
X
cLac
Lactate concentration (L-lactate)
Hct
Volume fraction of erythrocytes in blood (hematocrit)
X X
X
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
OSM
pH
Acidity or alkalinity
X
pCO2
Carbon dioxide tension
X
pO2
Oxygen tension
X
Calcium ion concentration
X
Potassium ion concentration
X
Sodium ion concentration
X
cCl–
Chloride ion concentration.
X
cGlu
Glucose concentration (Dglucose)
X
ctHb
Concentration of total hemoglobin
X
X
sO2
Oxygen saturation
X
X
FO2Hb
Fraction of oxygenated hemoglobin in total hemoglobin
X
X
FCOHb
Fraction of carboxyhemoglobin in total hemoglobin
X
X
FMetHb
Fraction of methemoglobin in total hemoglobin
X
X
FHHb
Fraction of deoxyhemoglobin in total hemoglobin
X
X
cCa cK
2+
+
cNa
+
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
X
X
cBase(B)
Concentration of actual titratable base in blood (actual base excess)
X
X
cBase(Ecf)
Concentration of standard titratable base in blood (standard base excess)
X
X
cBase(B,ox)
Concentration of actual titratable base in fully oxygenated blood
X
X
cBase(Ecf,ox) Concentration of standard titratable base in fully oxygenated blood
X
X
ctCO2(B)
Concentration of total carbon dioxide in blood (CO2 content)
X
X
ctCO2(P)
Concentration of total carbon dioxide in plasma (CO2 content)
X
X
cHCO3–(P,st)
Concentration of hydrogen carbonate ion (bicarbonate) in plasma of standardized blood (standard bicarbonate)
X
X
ctHb
Concentration of total hemoglobin in blood
X
X
cCa2+(7.4)
Concentration of ionized calcium in plasma at a pH of 7.40
X
X
Anion Gap (K+)
Concentration difference between (K+ + Na+) and (Cl– + HCO3–)
X
X
Anion Gap
Concentration difference between Na+ and (Cl– + HCO3–)
X
X
ABL80 FLEX Operator's Manual
Parameter Symbol
1. Introduction
Description
ABL80 FLEX Configuration FLEX
BASIC
ctO2
Concentration of total oxygen in blood (O2 content)
X
X
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”.
X
X
pO2(A)
Oxygen tension in alveolar air
X
X
pO2(A-a)
Alveolo-arterial oxygen tension difference
X
X
pO2(a/A)
Arterio-alveolar oxygen tension ratio
X
X
R/I
Respiratory index; the ratio between the oxygen tension difference of alveolar air and arterial blood and the oxygen tension of arterial blood
X
X
pH (T)
pH at patient temperature
X
X
pCO2 (T)
Carbon dioxide tension in blood at patient temperature
X
X
pO2 (T)
Oxygen tension in blood at patient temperature
X
X
pO2(A, T)
Oxygen tension in alveolar air at patient temperature
X
X
pO2(A-a, T)
Alveolo-arterial oxygen tension difference at patient temperature
X
X
pO2(a/A, T)
Arterio-alveolar oxygen tension ratio at patient temperature
X
X
R/I (T)
Respiratory index at patient temperature
X
X
mOsm
Osmolality
X
1-5