RADIOMETER
ABL80 FLEX Reference Manual Edition K
Reference Manual
217 Pages
Preview
Page 1
ABL80 FLEX reference manual
ABL80 FLEX reference manual
Table of contents
1. Introduction
ABL80 FLEX analyzer
2. Wet section
3. Electronics
4. Sensors
5. User-defined corrections
Reference manual 6. Performance characteristics
7. Parameters
8. Solutions
9. Interfacing facilities
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.
Radiometer, the Radiometer logo, ABL, AQT, TCM, RADIANCE, PICO and CLINITUBES are trademarks of Radiometer Medical, ApS. 2011 Radiometer Medical ApS, All rights reserved.
Table of contents Introduction
This manual refers to the function of all versions of the ABL80 FLEX analyzer. It describes how it measures and calibrates, which parameters are reported, and how the analyzer is tested.
Contents
This manual contains the following topics. 1. Introduction... 1-1 ABL80 FLEX documentation ...1-2 2. Wet section ... 2-1 Introduction ...2-2 Wet section diagram – ABL80 FLEX analyzer ...2-3 Wet section diagram – ABL80 FLEX CO-OX analyzer...2-5 Measuring processes ...2-8 General information ...2-9 Patient samples – ABL80 FLEX analyzer ...2-10 Patient samples – ABL80 FLEX CO-OX analyzer ...2-11 Manual QC samples – ABL80 FLEX analyzer...2-13 Manual QC samples – ABL80 FLEX CO-OX analyzer ...2-14 3. Electronics ... 3-1 General information ...3-2 Electronic boards and components...3-3 4. Sensors ... 4-1 Overview ...4-3 General construction ...4-3 General measuring principles...4-4 Potentiometric measuring principle ...4-5 Amperometric measuring principle...4-7 Conductometric measuring principle ...4-10 Calibration ...4-12 General information ...4-13 The calibration equation...4-14
Table of contents
ABL80 FLEX reference manual
Sensor parameter limits ...4-16 Sensitivity...4-17 Stability – electrical ...4-18 Stability – temperature ...4-19 Ranges – electrical ...4-20 Reference electrode...4-21 Background information about the reference electrode ...4-22 Construction of the reference electrode ...4-23 pH sensor ...4-24 Construction of the pH sensor ...4-25 Measuring principle of the pH sensor ...4-26 Calibration of the pH sensor ...4-29 Measurement – pH ...4-30 Corrections – pH ...4-31 pCO2 sensor ...4-32 Construction of the pCO2 sensor ...4-33 Measuring principle of the pCO2 sensor ...4-34 Calibration of the pCO2 sensor ...4-38 Measurement – pCO2 ...4-40 Correction – pCO2 ...4-41 pO2 Sensor ...4-42 Construction of the pO2 sensor ...4-43 Measuring principle of the pO2 sensor ...4-44 Calibration of the pO2 sensor ...4-47 Measurement – pO2 ...4-48 Correction – pO2 ...4-49 The electrolyte sensors ...4-50 Construction of the electrolyte sensors ...4-51 Measuring principle of the electrolyte sensors...4-52 Calibration of the electrolyte sensors ...4-54 Measurement – electrolytes...4-55
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ABL80 FLEX reference manual
Table of contents
Glucose sensor ...4-56 Construction of the Glu sensor...4-57 Measuring principle of the Glu sensor ...4-58 Calibration of the Glu sensor ...4-60 Measurement – Glu ...4-61 Conductivity electrodes ...4-62 Construction of the conductivity electrode ...4-63 Measuring principle of the conductivity electrode...4-64 Calibration of the conductivity electrode ...4-66 Measurement – Hct ...4-68 Optical system ...4-69 Measuring principle ...4-70 Calibration...4-76 Correcting for HbF interference ...4-77 Correcting for other interferences ...4-79 Measurement and corrections ...4-80 References ...4-82 5. User defined corrections ... 5-1 General information ...5-2 All parameters ...5-4 6. Performance characteristics ... 6-1 General information ...6-2 Reference methods...6-3 Testing against a reference method ...6-4 Reference methods for the ABL80 FLEX analyzers ...6-6 Performance tests ...6-7 Definition of terms ...6-8 Performance test conditions – ABL80 FLEX analyzer ...6-10
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Table of contents
ABL80 FLEX reference manual
ABL80 FLEX performance test results...6-11 Performance test conditions – ABL80 FLEX CO-OX analyzer ...6-18 ABL80 FLEX CO-OX performance test results ...6-19 Interference tests ...6-29 7. Parameters ... 7-1 Definitions and symbols ...7-2 General information ...7-3 Acid-base parameters ...7-5 Oxygen parameters ...7-7 Oximetry parameters ...7-10 Electrolyte/metabolite parameters...7-11 Units and ranges ...7-12 Introduction ...7-13 Measured parameters ...7-14 Input parameters...7-16 Derived parameters ...7-17 Equations ...7-20 General information ...7-21 List of equations ...7-22 Oxyhemoglobin dissociation curve (ODC) ...7-35 Conversion of units ...7-40 Default values ...7-42 References ...7-43 8. Solutions ... 8-1 General information ...8-2 Solutions...8-3 Certificate of traceability...8-5
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ABL80 FLEX reference manual
Table of contents
9. Interfacing facilities ... 9-1 General information ...9-2 Connecting an alphanumeric keyboard ...9-3 Connecting the external barcode scanner ...9-4 Connecting to a network ...9-5 Additional connections ...9-6 Index Date of issue
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Table of contents
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ABL80 FLEX reference manual
1. Introduction Overview
This section gives an introduction to the documentation that accompanies all versions of the ABL80 FLEX analyzer. It describes how this particular manual is organized and explains the different notices that appear in it.
Contents
This chapter contains the following topics. ABL80 FLEX documentation ...1-2
1. Introduction
ABL80 FLEX reference manual
ABL80 FLEX documentation ABL80 FLEX
The documentation that accompanies all ABL80 FLEX analyzers includes practical and theoretical information regarding the function and use of the analyzer.
Documentation
The table below describes documentation available for this analyzer. Documentation The operator’s manual
Description • Contains all the information required for everyday operation of the analyzer. • Describes the functions of the analyzer and how to set it up according to customer needs and requirements. • Explains error messages and gives troubleshooting procedures. • Contains ordering information
The reference manual
• Provides detailed information about the operating principles of the analyzer. • Describes the measuring and calibrating principles. • Lists all the parameters. • Provides the equations from which the derived parameters are calculated. • Provides information about how the performance of the analyzer is tested.
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2. Wet section Introduction
This chapter describes the wet section of the ABL80 FLEX and ABL80 FLEX CO-OX analyzers.
Contents
This chapter contains the following topics. Introduction ...2-2 Wet section diagram – ABL80 FLEX analyzer ...2-3 Wet section diagram – ABL80 FLEX CO-OX analyzer ...2-5 Measuring processes ... 2-8 General information ...2-9 Patient samples – ABL80 FLEX analyzer ...2-10 Patient samples – ABL80 FLEX CO-OX analyzer...2-11 Manual QC samples – ABL80 FLEX analyzer ...2-13 Manual QC samples – ABL80 FLEX CO-OX analyzer ...2-14
2. Wet section
ABL80 FLEX reference manual
Introduction Definition
The wet section of the analyzer is where all samples and solutions are transported for measurement, calibration and rinse.
Contents of wet section
The main components of the wet section are: • Sensor cassette • Internal tubing • Peristaltic pumps for sample aspiration, calibration and waste • Valve / manifold assembly • Solution pack • Hemolyzer (ABL80 FLEX CO-OX analyzer only)
Solutions
All solutions for the ABL80 FLEX analyzer (all versions) are contained in the solution pack.
Gases
Gas tanks are not necessary with the ABL80 FLEX analyzer (all versions). The multiple levels of solutions are tonometered and sealed in gastight disposable pouches, without a gas phase. This eliminates the need for gas tanks, and temperature or barometric pressure corrections.
Window
A window in the sensor cassette allows the user to view the sample path at the location of the measuring sensors for pH, blood gas, electrolyte and glucose measurements.
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ABL80 FLEX reference manual
2. Wet section
Wet section diagram – ABL80 FLEX analyzer Introduction
The wet section of the ABL80 FLEX analyzer is comprised of the following components: • Sensor cassette • Internal tubing, valves, and manifold interface • Sample pump and waste pump • Solution pack
Diagram
The following is a schematic diagram of the wet section of the ABL80 FLEX analyzer.
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2. Wet section
Parts table
ABL80 FLEX reference manual
The table below describes the functions of the main parts of the ABL80 FLEX wet section. Item
2-4
Part
Function
1
Inlet probe
The point of introduction for the sample into the sensor cassette. It also provides a pathway for calibration/QC solution to be flushed to the waste drain.
2
Waste drain
Receptacle which receives waste fluids from the inlet probe during flush cycles.
3
Main waste line
Internal tubing, which provides the pathway for waste fluid transport to the waste pouch contained in the solution pack.
4
Cassette measuring chamber
The area of the cassette which contains the sensor array and where the actual measurements occur.
5
Roller pump
Provides the pumping mechanism to transport fluids across the cassette sensor array.
6
Cassette luer
The fluid connection port between the analyzer and the sensor cassette.
7
Side waste line
Tubing connection that provides a pathway for excess fluid to be transported to the waste pouch contained in the solution pack.
8
Waste valve
Internal valve that controls the flow of waste fluids into the waste pouch contained in the solution pack.
9
Waste pump
Pump that transports waste fluids to the waste pouch contained in the solution pack.
10
Valves
Internal valves that control the selection and flow of solutions from the solution pack to the sensor cassette.
11
Manifold
Interface between the solution pack, valves and the analyzer wet section.
12
Fluid port luer
These luers penetrate the valves of the sealed pouches in the solution pack to provide fluid flow.
13
Solution pack
Contains five sealed pouches, four solution pouches and a waste pouch.
14
Solution pouches
Four pouches with precision-tonometered electrolyte solutions.
15
Waste pouch
Pouch to collect and contain all waste fluids in the system.
ABL80 FLEX reference manual
2. Wet section
Wet section diagram – ABL80 FLEX CO-OX analyzer Introduction
The wet section of the ABL80 FLEX CO-OX analyzer is comprised of the following components: • Sensor cassette • Internal tubing, valves, and manifold interface • Sample pump and waste pump • Solution pack • Hemolyzer and sample cuvette
Diagram
The following is a schematic diagram of the wet section of the ABL80 FLEX analyzer.
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2. Wet section
Parts table
ABL80 FLEX reference manual
The table below describes the functions of the main parts of the ABL80 FLEX wet section. Item
2-6
Part
Function
1
Inlet probe
The point of introduction for the sample into the sensor cassette. It also provides a pathway for calibration/QC solution to be flushed to the waste drain.
2
Waste drain luer
Luer which receives waste fluids from the inlet probe during flush cycles.
3
Main waste line
Internal tubing, which provides the pathway for waste fluid transport to the waste pouch contained in the solution pack.
4
Cassette measuring chamber
The area of the cassette which contains the sensor array and where the actual measurements occur for pH, blood gases, electrolytes and glucose.
5
Cassette luer
The fluid connection port between the analyzer and the sensor cassette.
6
Pinch valve
Valve used in the measurement of co-oximeter parameters
7
Hemolyzer
Ultrasonic hemolyzer which contains the hemolyzed sample in a cuvette during measurement
8
Liquid sensor
Senses the location of the sample in the pathway, ensuring the sample has successfully been transported through the hemolyzer
9
Spectrometer
Uses a photodiode array to measure the wavelengths of the sample and create an absorption spectrum
10
Sample pump
Provides the pumping mechanism to transport fluids through the hemolyzer and across the cassette sensor array
11
Vent valve
Internal valve that controls the flow of waste fluids into the waste pouch contained in the solution pack.
12
Waste pump
Pump that transports waste fluids to the waste pouch contained in the solution pack.
ABL80 FLEX reference manual
Item
2. Wet section
Part
Function
13
Valves
Internal valves that control the selection and flow of solutions from the solution pack to the sensor cassette
14
Manifold
Interface between the solution pack, valves and the analyzer wet section
15
Fluid port luer
These luers penetrate the valves of the sealed pouches in the solution pack to provide fluid flow.
16
Solution pack
Contains five sealed pouches, four solution pouches and a waste pouch.
17
Solution pouches
Four pouches with precision-tonometered electrolyte solutions and dyes.
18
Waste pouch
Pouch to collect and contain all waste fluids in the system.
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