The software installed and provided with the instrument is comprised of Microsoft®
CE Operating System and SenDx Medical, Inc. developed Software. Each program
is licensed, not sold to you, to be used only under the terms of this Agreement and
the Microsoft End User License Agreement. SenDx Medical, Inc. and its licensors
reserve all rights not expressly granted to you. You may use the software only with
the instrument in which it is installed for your internal purposes. When the instrument
is transferred to others, it must be accompanied by the software and the End User
License Agreements included in the Operator’s Manual. The software may not be
copied. You may not modify, reverse engineer, decompile or disassemble the
programs. By your use of the instrument you agree to the terms of this Agreement
and the Microsoft End User License Agreement. If you do not accept or agree to the
terms you should promptly contact your Radiometer representative for a return of the
instrument and a refund of your money.
TRADEMARKS
ABL™, and RADIOMETER™ are trademarks of Radiometer Medical A/S, Denmark.
ABL is registered in the USA.
COPYRIGHT
The contents of this document may not be reproduced in any form or communicated
to any third party without the prior written consent of Radiometer Medical A/S.
While every effort is made to ensure the correctness of the information provided in
this document Radiometer Medical A/S assumes no responsibility for errors or
omissions which nevertheless may occur.
This document is subject to change without notice.
Recommended Parts And Hardware................................................. 9-21
Continued on next page
Rev. F 5
Table of Contents ABL77 Service Manual
Table of Contents, Continued
Service Notes
Date of Issue
6 Rev. F
ABL77 Service Manual Chapter 1: Introduction
1. Introduction
Overview
Introduction
Contents
This chapter gives an introduction to the servicing of the ABL™77 analyzer and
important information for understanding the procedures and requirements.
This section outlines the policies and procedures, which must be followed when
servicing Radiometer Medical A/S instruments.
The service policy for the ABL77 Series has been outlined to obtain a maximum
degree of reliability with minimal repair time.
Further, a combination of comprehensive troubleshooting procedures in the service
manual, a variety of self-check and service programs, and a high degree of
modularization facilitates quick localization of faults in the analyzers.
Using the test equipment, procedures and spare parts listed in this service manual
ensures continuous reliability.
Exceptions from the service policy are not allowed unless special permission or
instructions in writing have been given beforehand by SenDx Medical, Inc.
Radiometer Medical A/S cannot guarantee the instrument’s performance
specifications and safety or accept any warranty claims unless:
Non-original
parts
Electrostatic
discharge
protection
• The recommended maintenance procedures outlined in the Operator’s and
Service Manuals are performed.
• The accessories and spare parts specified by Radiometer Medical A/S are used.
Warranty claims for parts which suffer from physical damage, unauthorized
attempted repair, or exposure to conditions other than those specified by
Radiometer Medical A/S (e.g., temperature, line voltage outside specified limits)
will not be accepted.
Spare parts and accessories
In order to ensure the reliability, durability and operation in accordance with
technical specifications, use only original Radiometer Medical A/S parts, or parts
approved by Radiometer Medical A/S.
This concerns both spare parts and accessories.
Software
Software is considered to be a spare part. Only software distributed by Radiometer
may be installed in the analyzer.
In order to ensure the reliability and durability of the analyzer, ESD protection
precautions must always be taken when handling or exposing ESD sensitive parts.
Parts such as printed circuit boards may be damaged if handled incorrectly during
storage and service. The damage is not visible, and the damaged parts may not fail
immediately but several months later.
Installation test
In connection with the installation, repair and upgrade of an analyzer it is usually
required that an Installation Test be carried out to verify that the analyzer calibrates
correctly and measures correctly using the appropriate quality control solution.
Continued on next page
1-2 Rev. F
ABL77 Service Manual Chapter 1: Introduction
Service Policy, Continued
Repair level
The repair level outlines the extent to which it is allowed to dismantle an analyzer
in the process of troubleshooting and repair. This level is limited for several
reasons such as: the need for specialized test equipment, special environmental
requirements etc., and is optimized in relation to cost of parts, time for repair, etc.
The repair level is indicated in the chapters (5) Dismantling, (7) Re-Assembly and
(9) Spare Parts.
Electronics Module
The major components in the electronics module are printed circuit boards. Lowlevel repair of these boards is not allowed in the field. Most of the boards are based
on surface mounted technology, which involves a high component density and
thereby a high complexity. Repair of this type of printed circuit board (PCB)
requires advanced troubleshooting, repair and test facilities, which are only
available at the factory. Some PCBs may be returned to the factory for replacement
under the trade-in agreement for modules. These PCBs are marked with “*” next to
the description in the spare parts list. Since repair is not allowed in the field,
detailed circuit diagrams are not included in the service manual.
Lower Module
Most of the electromechanical and pure mechanical parts of the lower module may
be repaired to the component level. Tubing, the printer, and pump motors are
regarded as components (or component assemblies). The various programs
facilitate checkout and adjustment of these parts and also verification of their
function after repair.
Some mechanical adjustments are critical for their function. Such parts are not to
be dismantled further than indicated in the spare parts list.
Upper Module
The upper module may be repaired to the component level. The various programs
facilitate checkout and adjustment of these parts and also verification of their
function after repair.
Some mechanical adjustments are critical for their function. Such parts are not to
be dismantled further than indicated in the spare parts list.
Continued on next page
Rev. F 1-3
Chapter 1: Introduction ABL77 Service Manual
Service Policy, Continued
WARNING/
CAUTION:
Calibration and
measurement
CAUTION: Follow legal requirements and local rules for safe work practices with
chemicals.
CAUTION: Working with blood gas analyzers may result in contact with blood
remnants and with harsh disinfectants. During the various procedures wear suitable
protection gear (gloves, face protection, and protective body clothing) and follow
legal requirements and local rules for safe work practices.
CAUTION: The gloves must be free of pinholes and preferably be puncture
resistant. Please consult the glove manufacturer for further information.
CAUTION: If contaminated materials come into contact with any lesion on the
body, seek medical advice.
While performing calibrations and measurements, the analyzer must be fully
assembled.
ECOMMENDATION: To facilitate troubleshooting procedures, consider purchasing
R
one of each analyzer module to use as a test module.
1-4 Rev. F
ABL77 Service Manual Chapter 1: Introduction
Test Equipment and Tools
Required
equipment and
tools
REF Description Use
902-6XX SCi sensor cassette Testing analyzer after repair
944-069 Calibration solutions pack (cal pack) Testing analyzer after repair
913-741 Manager setup disk Custom setup of system features
920-721 5/64” ball point Allen wrench Various applications
920-722 1/16” ball point Allen wrench Lower module
920-723 7/64” ball point Allen wrench Lower module
To carry out the procedures for servicing the analyzer, the following test
equipment and tools are required: Parts marked with “N/A” in the REF column are
to be purchased locally.
920-726 5/16” open-end wrench Electronics module
920-727 5/16” nut driver Electronics and Lower modules
920-728 ¼” nut driver Electronics module
920-729 Valve board calibration cassette Calibrating the Hct and SC circuit
991-260 Loctite 401 Adhesive Securing the handle to the housing
991-264 Silicone adhesive, RTV medical grade Securing cables to prevent disconnect
991-265 Loctite 222 Threadlocker Securing assorted screws and nuts
905-674 Sample path obstruction tool kit Various applications
943-906 Cleaning solution Cleaning the waste drain
N/A Deionized water (or sterile water) Various applications
N/A Soft cloth, gauze or other absorbent material Various applications
N/A Protective attire (gloves, safety glasses, and lab
Various applications
coat)
N/A Flat head screwdriver
Lower module
N/A Small flat head screwdriver Adjusting the calibration settings
N/A Phillips head screwdriver Various applications
N/A Needle nose pliers Lower module
N/A Scissors or equivalent trimming tool Various applications
N/A AT style keyboard Entering system commands
N/A Digital multimeter Testing electronics
N/A Digital voltmeter (or multimeter) 5 volt power output setting
N/A 3½” formatted diskettes Downloading data files
N/A Index card or equivalent Block the opto sensor
Rev. F 1-5
Chapter 1: Introduction ABL77 Service Manual
ABL77 Identification
Introduction
ABL77
identification
Elements
This section explains the identification system for the ABL77 product.
Each individual analyzer consists of a number of separate elements, some using a
unique identification system. These numbers are used for a large variety of
purposes, e.g. tracking.
An analyzer consists of the following elements:
Element Element ID Syntax
Analyzer Serial number 200001
Sensor Cassette Lot number 52657
Serial number 041403150
Cal pack Lot number 52630
Use of
identification
Electronic serial
number
Serial number 52630124
Bar code scanner Part number / Revision 902-660
Battery Charger Part number / Revision 905-743
Manager Setup disk Part number / Revision 913-741
Operator’s Manual, English Part number / Revision 989-555
The analyzer serial number is the primary identification number, e.g.:
• For tracking purposes (both for the analyzer and it’s modules).
• For logging service actions.
• As a reference on service work orders.
• When ordering service components and modules.
The analyzer serial number is stored electronically in the ChipDisk. When the
ChipDisk or the electronics module is replaced, the serial number must be reprogrammed into the analyzer.
During service the system will recognize that there is no serial number and require
serial number entry upon startup before proceeding. Ensure the serial number
entered matches the serial number label located inside the printer door.
Serial number
label
replacement
1-6 Rev. F
The analyzer serial number label is located inside the analyzer printer door. In the
event that the printer door must be replaced, a new printer door with serial number
label must be ordered and produced at the factory.
ABL77 Service Manual Chapter 1: Introduction
Panel Options
Introduction
Available
options
Management
This section explains the panel options available with the ABL77 analyzer. When
servicing an analyzer it should always be returned to the same settings.
The ABL77 can be configured for the following options:
• Blood gas and Hematocrit Only (BG/Hct)
• Electrolytes Only (Lytes)
• Full Panel (BG/Hct/Lytes)
The different analyzer configurations are controlled through the analyzer software
configuration at the time of purchase. The analyzer can be upgraded or
downgraded after purchase.
The same configurations are also available in sensor cassette types. The different
types are controlled through the sensor cassette barcode.
A full panel sensor cassette may be used on any analyzer configuration. The
analyzer will report “ NI ” (Not Installed) for non-configured parameters.
A BG/Hct or Lytes sensor cassette will only report their respective configured
parameters when installed on a full panel analyzer. Other parameters not supported
by the sensor cassette configuration will be reported as “NI”.
When attempting to install a BG/Hct sensor on a Lytes only analyzer (or
vice-versa), the analyzer will reject the installation.
Rev. F 1-7
ABL77 Service Manual Chapter 2: Analyzer Description
2. Analyzer Description
Overview
Introduction
Contents
This chapter provides a general description of the analyzer modules, the electronic
boards, the electronics wiring diagrams, and the fluidics system. This chapter
includes various drawings for use during servicing. The drawings indicate the
location of connection points and general identification.
Chapter 2: Analyzer Description ABL77 Service Manual
Functional Description
Introduction
Overview
This section provides a general introduction to the analyzer.
The ABL77 Analyzer is an electromechanical instrument designed to measure
blood gas, pH, and electrolyte concentrations of whole blood.
Intended use
Measuring
principles
The heart of the ABL77 analyzer is a 486 SX single board computer. It operates on
custom software in a Microsoft
®
Windows CE operating system. Peripherals
include a floppy disk, VGA color monitor with touch screen, thermal printer and a
custom board that performs all analog input and output functions.
An external AC to DC power supply provides system power. On board batteries
enable portable operation of the analyzer. An intelligent power control board
monitors system power and battery charge cycles.
After use, the analyzer may contain blood residue. Follow the Long-Term Storage Procedure in Chapter 8 to decontaminate the analyzer. Following
decontamination, the ABL77 analyzer should be disposed of in a safe and proper
manner.
The ABL77 pH, blood gas and electrolyte analysis system is a portable, automated
analyzer that measures blood oxygen, carbon dioxide, pH, sodium, potassium,
chloride, ionized calcium and hematocrit in whole blood. The ABL77 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.
There are three different measuring principles employed.
• Potentiometry: A potential is recorded using a voltmeter, which relates to the
concentration of the sample. A reference electrode is used to provide a stable,
fixed potential against which other potential differences can be measured. Used
for pH, CO
and electrolytes.
2
• Amperometry: The magnitude of an electrical flow of current is proportional to
the concentration of the substance being oxidized or reduced at an electrode.
Used for O
.
2
• Conductivity: The specific impedance of a sample as measured by two
conducting electrodes held at a constant voltage is directly proportional to the
conductive properties of the sample. Used for hematocrit and air-in-sample
detection.
Operating
conditions
The ABL77 system can be operated at an ambient temperature of 12-28 °C
(54-82 °F).
All calibration solution packs should be stored at temperatures between 12-28 °C
(54-82 °F). Do not freeze or expose to excessive heat or direct sunlight.
All sensor cassettes should be stored at temperatures between 5-32 °C (41-90 °F).
Do not freeze or expose to excessive heat or direct sunlight.
Altitude
conditions
2-2 Rev. F
The ABL77 system can be operated at altitudes from sea level to 1600 meters.
ABL77 Service Manual Chapter 2: Analyzer Description
SCi Installation
Sensor cassette
installation
Initializationhydration
Initializationcalibration
attempts
When a new sensor cassette is installed on the analyzer, the software will perform
an initialization procedure to prepare the cassette for use. This initialization process
consists of a preparatory hydration phase followed by a number of calibration
attempts.
• Cal1 flush is a preliminary flush to help expel air bubbles. A message “Please
wait….” appears for 10 seconds.
• A second Cal1 flush allows the new sensors to be conditioned with calibration
solution. A message “Hydrating….” appears for 2 minutes.
• Following hydration, the analyzer attempts a series of two point calibrations.
• The number of calibrations performed is dependent on the results of each
attempt. The minimum number of attempts is 1 and the maximum number of
attempts is 4.
Initialization
completed
• There are three failure conditions recognized by the software logic that
determine whether the initialization process continues or terminates, and what
messages are displayed. The three conditions are:
1. A single, mild sensor failure: One sensor sensitivity value falls between
50 – 100% of the minimum acceptable value. This is considered a
condition that may resolve itself with additional calibration attempts.
2. A single, severe sensor failure: One sensor sensitivity value falls between 0
– 50% of the minimum acceptable value. This is considered a condition
that is unlikely to resolve itself.
3. All other failure modes: Multiple sensor sensitivity values fall outside the
acceptable values, no endpoint errors are present, and other conditions
which may indicate air in the measuring chamber.
Following a successful initialization, the first auto calibration is scheduled for 30
minutes after initialization. Second and third calibrations are scheduled for 60
minutes after initialization and 120 minutes after initialization, respectively. From
this point calibrations follow the schedule entered in the Calibration Schedule
screen under Manager Setup / System Setup.
Rev. F 2-3
Chapter 2: Analyzer Description ABL77 Service Manual
This page intentionally left blank
2-4 Rev. F
ABL77 Service Manual Chapter 2: Analyzer Description
Calibration
Introduction
Hydration
The user can define the frequency of automatic two-point calibrations. The
possible intervals are 1, 2, 3 or 4 hours. The Calibration option on the Main Menu is used to initiate a manual two- point calibration as desired.
If the calibration is more than 30 minutes past the scheduled time, a preliminary
flush of Cal1 solution is performed prior to the two-point calibration. A message
“hydrating….” will be displayed.
Continued on next page
Rev. F 2-5
Chapter 2: Analyzer Description ABL77 Service Manual
Calibration, Continued
Calibrationphase 1
• During the first phase of the calibration process, the roller wheel is activated
along with valves 1 and 3. This flushes Cal2 solution through the sensor cassette
measuring chamber (see Figure 2-1).
• A measurement is then made on this solution.
• The waste pump is also activated to transport residual flush solution to the waste
pouch.
Figure 2-1
Continued on next page
2-6 Rev. F
ABL77 Service Manual Chapter 2: Analyzer Description
Calibration, Continued
Calibrationphase 1
(continued)
Part Function
1. Cal1 solution (Calibration solution – Level 1)
2. Cal2 solution (Calibration solution – Level 2)
3. Waste bag
4. Cal Pack
5. Main waste line
6. Manifold
7. Manifold luers
8. Side waste line
9. Valves L1, L2 and L3
10. Cassette measuring chamber
11. Roller wheel
12. Inlet probe
13. Waste drain
14. Waste pump
15. Cassette luer
Continued on next page
Rev. F 2-7
Chapter 2: Analyzer Description ABL77 Service Manual
Calibration, Continued
Calibration –
phase 2
• During the second phase of the calibration, the roller wheel is activated along
with valves 2 and 3. This flushes Cal1 solution through the sensor cassette
measuring chamber (see Figure 2-2).
• A measurement is made on this solution.
• The waste pump is also activated to transport residual flush solution to the waste
pouch.
Figure 2-2
Continued on next page
2-8 Rev. F
ABL77 Service Manual Chapter 2: Analyzer Description
Calibration, Continued
Calibration –
phase 2
(continued)
Part Function
1. Cal1 solution (Calibration solution – Level 1)
2. Cal2 solution (Calibration solution – Level 2)
3. Waste bag
4. Cal Pack
5. Main waste line
6. Manifold
7. Manifold luers
8. Side waste line
9. Valves L1, L2 and L3
10. Cassette measuring chamber
11. Roller wheel
12. Inlet probe
13. Waste drain
14. Waste pump
15. Cassette luer
Continued on next page
Rev. F 2-9
Chapter 2: Analyzer Description ABL77 Service Manual
Calibration, Continued
Sensitivity
values
• Calibration sensitivity values are calculated based on these two measurements.
• These sensitivity values are compared to the acceptable range.
• If the values are acceptable, the calibration is complete.
• If one or more sensitivity values are outside the acceptable range, the
calibration is automatically repeated. If repeat calibration also results in one or
more parameter sensitivity values outside the acceptable range, the software
will suggest the appropriate next step. Suggestions include investigating the
fluidic pathways of the analyzer, inactivating the sensor, or replacing the
sensor cassette.
Parameter Acceptable Sensitivity Range
pH 40.0 – 61.5
CO2 30.0 – 61.5
Failed
calibration
status
O2 0.002 – 0.052
Na+ 40.0 – 61.5
K+ 40.0 – 61.5
Ca2+ 20.0 – 31.0
Cl– 30.0 – 61.5
Hct 10.0 – 25.0
If the calibration fails, the system will revert to a mandatory four-hour cycle of
two-point calibrations (without repeating) to maintain the fluidic system. A
successful calibration will return the analyzer to the calibration interval entered
into the Calibration Schedule.
2-10 Rev. F
ABL77 Service Manual Chapter 2: Analyzer Description
This page intentionally left blank
Rev. F 2-11
Chapter 2: Analyzer Description ABL77 Service Manual
Sample Analysis
Introduction
Analysis – initial
flush
Analysis – phase
1 aspiration
The Analysis option on the Main Menu allows the user to initiate a sample
analysis.
Pressing the Analysis icon initiates a brief flush of Cal1 solution to ensure the tip
of the inlet probe is filled with fluid.
• To begin the sample analysis, the inlet probe flap is lifted to the syringe or
capillary position.
• The Aspirate button is then pressed.
• The primary sample pump then draws in 70 microLiters of sample (see
Figure 2-3).
Figure 2-3
Continued on next page
2-12 Rev. F
ABL77 Service Manual Chapter 2: Analyzer Description
Sample Analysis, Continued
Analysis – phase
1 aspiration
(continued)
Part Function
1. Cal1 solution (Calibration solution – Level 1)
2. Cal2 solution (Calibration solution – Level 2)
3. Waste bag
4. Cal Pack
5. Main waste line
6. Manifold
7. Manifold luers
8. Side waste line
9. Valves L1, L2 and L3
10. Cassette measuring chamber
11. Roller wheel
12. Inlet probe
13. Waste drain
14. Waste pump
15. Cassette luer
Continued on next page
Rev. F 2-13
Chapter 2: Analyzer Description ABL77 Service Manual
Sample Analysis, Continued
Analysis – phase
2 aspiration
• The analyzer prompts the user to remove the sample and lower the inlet probe
• The analyzer then advances the sample a second time to complete the positioning
of the sample (see Figure 2-4).
Figure 2-4
Continued on next page
2-14 Rev. F
ABL77 Service Manual Chapter 2: Analyzer Description
Sample Analysis, Continued
Analysis – phase
2 aspiration
(continued)
Part Function
1. Cal1 solution (Calibration solution – Level 1)
2. Cal2 solution (Calibration solution – Level 2)
3. Waste bag
4. Cal Pack
5. Main waste line
6. Manifold
7. Manifold luers
8. Side waste line
9. Valves L1, L2 and L3
10. Cassette measuring chamber
11. Roller wheel
12. Inlet probe
13. Waste drain
14. Waste pump
15. Cassette luer
Continued on next page
Rev. F 2-15
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