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A15 MS Eng

This service manual provides information on the intended use, description, functioning, transport, and modifications of the A15 analyzer. It describes the mechanical, electronic, and software components and includes sections on initialization, adjustments, tests, and troubleshooting of the analyzer.

Uploaded by

Megdame Ibrahim
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© © All Rights Reserved
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0% found this document useful (0 votes)
609 views170 pages

A15 MS Eng

This service manual provides information on the intended use, description, functioning, transport, and modifications of the A15 analyzer. It describes the mechanical, electronic, and software components and includes sections on initialization, adjustments, tests, and troubleshooting of the analyzer.

Uploaded by

Megdame Ibrahim
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 170

Service

Manual
English
Manual version Revision data Modification
02 April 20120 Added chapters: Notices and Warns,
Licences
Modification of the chapter: 3, 5.2.7, 6,
7, AII, AIII, AV, AVI
01 November 2017 Modification of the chapter 1.4, 4.2.3.4,
4.2.7 and AV
00 May 2017 Modification to add the refrigerator
model

Manual code TESE000015-02-ENG

Manufacturer’s address BIOSYSTEMS


c/Costa Brava 30,

08030 Barcelona

SPAIN


http://www.biosystems.es

The A15 is compliant with EU directive 98/79/EC

The Y15 is compliant with the low voltage directive 2014/35 / EU and the electromag-
netic compatibility directive 2014/30 / EU of the European Union.
TABLE OF CONTENTS

Persons for whom this manual is intended........................................ 9


Notices and warnings........................................................................... 9
Software usage licence....................................................................... 13
1. Intended use.................................................................................. 14
2. Introduction................................................................................... 15
2.1. General description of the analyzer............................................................................15
2.1.1. Operating arm.................................................................................................................................... 16
2.1.2. Dispensing system............................................................................................................................ 16
2.1.3. Reactions rotor and reading............................................................................................................. 17
2.1.4. Electronic system.............................................................................................................................. 18
2.1.5. Application program.......................................................................................................................... 18
2.2. Functioning of the analyser.........................................................................................19
2.3. Transport and reshipment of the analyzer.................................................................19
2.4. Analyzer modifications to analyze stool analytes.....................................................20
3. Mechanical elements.................................................................... 22
3.1. Part of the instrument..................................................................................................22
3.2. Description of the mechanical elements....................................................................22
3.2.1. Operating arm.................................................................................................................................... 22
3.2.2. Needle unit......................................................................................................................................... 24
3.3. Dispensing system.......................................................................................................25
3.3.1. Dispensing pump.............................................................................................................................. 25
3.3.2. Tubes and containers........................................................................................................................ 27
3.3.3. Container level control sensors....................................................................................................... 28
3.3.4. Racks tray with integrated washing station.................................................................................... 28
3.3.5. Washing pumps................................................................................................................................. 29
3.4. Reaction rotor with integrated optical system..........................................................29
3.4.1. Thermostated rotor and photometric system................................................................................. 29
3.4.2. Lighting system................................................................................................................................. 30
3.4.3. Housing and covers.......................................................................................................................... 32
3.4.4. Reagents cooler................................................................................................................................. 35
4. Electronic system......................................................................... 36
4.1. Description of the electronics of the A15 analyzer....................................................36
4.2. CPU Board (CIIM00026)................................................................................................36
4.3. Power Supply Board (CIIM00015)...............................................................................41
4.4. Needle Board (CIIM00017)...........................................................................................41
4.5. Photometry Board (CIIM00027)...................................................................................42
4.6. XYZ Interconnection Board (CIIM00018)....................................................................43
4.7. Communications Board (CIIM00019)..........................................................................44
4.8. Rotor interconnection board (CIIM00029)..................................................................45
4.9. Pump interconnection board (CIIM00028)..................................................................47
4.10. Refrigerator cooler board (CIIM00075).....................................................................49
4.11. Auxiliar channel information.....................................................................................50
4.12. Interconnection between boards..............................................................................53
4.13. Schematic liquid circuit.............................................................................................60
5. Service program........................................................................... 61
5.1. Initialising the analyser................................................................................................61
5.2. Adjustments .................................................................................................................63
5
Service manual

5.2.1. Adjustment of the needle thermostatation system........................................................................ 64


5.2.2. Adjustment of the rotor thermostation system.............................................................................. 64
5.2.3. Adjustment of the positioning of the operating arm...................................................................... 65
5.2.3.1. Adjustment of X, Y and Z position for reagent and pediatric racks...................................... 65
5.2.3.2. Instruments with reagent cooler.............................................................................................. 68
5.2.3.3. Adjustment of Z-axis of tubes................................................................................................. 68
5.2.3.4. Stool tubes Z-axis adjustment................................................................................................. 69
5.2.4. Adjustment of the positioning of the rotor...................................................................................... 69
5.2.4.1. Centering of the rotor with regard to the dispensing point................................................... 70
5.2.4.2. Centering of the rotor with regard to the optical system...................................................... 71
5.2.5. Adjustment of the positioning of the filter wheel........................................................................... 71
5.2.6. Adjustment of the level control scales............................................................................................ 72
5.2.7. Adjustment of the level detection sensitivity.................................................................................. 73
5.2.8. Instruments with reagents cooler.................................................................................................... 73
5.2.9. Sensitivity adjustment in the analyzer to determine stool analytes ............................................ 74
5.2.10. Select the model of the instrumento............................................................................................. 75
5.3. Tests...............................................................................................................................75
5.3.1. Motor tests......................................................................................................................................... 75
5.3.1.1. Initialization test........................................................................................................................ 76
5.3.1.2. Movement test........................................................................................................................... 76
5.3.1.3. Loss step test............................................................................................................................ 77
5.3.1.4. tress mode test.......................................................................................................................... 77
5.3.1.5. Z axis secu­ri­ty systems test..................................................................................................... 78
5.3.1.6. Maximum Z verification test..................................................................................................... 78
5.3.2. Diaphragm pumps and electrovalves test...................................................................................... 79
5.3.2.1. Functioning test......................................................................................................................... 79
5.3.2.2. Stress mode test........................................................................................................................ 79
5.3.3. Needle self-centering system test................................................................................................... 79
5.3.4. Needle level detection system test.................................................................................................. 80
5.3.5. Needle thermostatation system test................................................................................................ 81
5.3.6. Needle rotor thermostatation system test...................................................................................... 82
5.3.7. Photometry tests............................................................................................................................... 82
5.3.7.1. Base line and integration times............................................................................................... 82
5.3.7.2. Darkness counts........................................................................................................................ 84
5.3.7.3. Repeatability without moving the filter wheel........................................................................ 84
5.3.7.4. Stability....................................................................................................................................... 85
5.3.7.5. Repeatability moving filter wheel............................................................................................. 85
5.3.7.6. Absorbance measurement........................................................................................................ 86
5.3.7.7. Reactions rotor check............................................................................................................... 86
5.3.8. Level control scales test................................................................................................................... 87
5.3.9. Covers detection test........................................................................................................................ 87
5.3.10. PC-Analyzer communications channel test.................................................................................. 88
5.3.11. Global stress mode of the analyzer............................................................................................... 88
5.3.12. Photometry tool............................................................................................................................... 89
5.4. Utilities ..........................................................................................................................90
5.4.1. Disassembly of the dispensing needle........................................................................................... 90
5.4.2. Fluid system supply.......................................................................................................................... 91
5.4.3. Cleaning of the dispensing system................................................................................................. 91
5.4.4. Changing the lamp............................................................................................................................ 92
5.4.5. Configuration of the filter wheel....................................................................................................... 93
5.4.6. Demonstration mode......................................................................................................................... 94
5.4.7. Read/load adjustments and cycles.................................................................................................. 94
5.4.8. Change the rotor type....................................................................................................................... 95
5.5. Register.........................................................................................................................96
5.5.1. Introducing the analyzer serial number.......................................................................................... 96
5.5.2. Service Reports................................................................................................................................. 97
5.5.3. Language change.............................................................................................................................. 97
5.5.4. Users................................................................................................................................................... 98
5.6. Monitor .........................................................................................................................98
6
5.7. User’s program ............................................................................................................98
5.7.1. Configuration of the level of access to the analyser .................................................................... 99
5.7.2. Reagent Consumption ................................................................................................................... 100
5.7.3. Location of the different software files.......................................................................................... 101
6. Spare parts explanation ............................................................ 103
6.1. Hosing and cover.......................................................................................................103
6.1.1. AC17350 - Lower arm housing / AC17349 - Upper arm housing................................................. 103
6.1.2. AC17352 - Front housing................................................................................................................ 103
6.1.3. AC173545 - General instrument cover........................................................................................... 104
6.1.4. AC17318 - Refrigerator housing..................................................................................................... 105
6.1.5. AC17349 - Upper housing............................................................................................................... 105
6.1.6. ME13377 - Hydro-pneumatic hinge cylinder................................................................................. 106
6.2. Manipulator arm..........................................................................................................107
6.2.1. MO13351 - Motor X.......................................................................................................................... 107
6.2.2. MO13353 - Y Motor / ME13352 - Y Belt........................................................................................... 108
6.2.3. MO13354 - Z motor / AC13765 Z axis encoder.............................................................................. 109
6.2.4. ME13355 - Spring set...................................................................................................................... 110
6.2.5. AC14307 - Arm cables / AC13360 - Tip clamp fitting.....................................................................111
6.2.6. AC13356 - Thermostat tip assembly.............................................................................................. 112
6.3. Dosing system............................................................................................................113
6.3.1. AC17316 - Manifold.......................................................................................................................... 113
6.3.2. AC11527 - Piston seal...................................................................................................................... 116
6.3.3. AC16594 - Ceramic piston + motor................................................................................................ 117
6.3.4. ME13367 - Waste pump................................................................................................................... 118
6.3.5. AC17317 - Manifold tube................................................................................................................. 119
6.4. Reaction and reading rotor........................................................................................120
6.4.1. AC13370 - Complete reaction set................................................................................................... 120
6.4.2. AC13371 - Rotor temperature sensor............................................................................................ 120
6.4.3. AC13373 - Rotor cover detector..................................................................................................... 121
6.4.4. AC14497 - Rotor Peltier Cells / MO13357 - Rotor fan................................................................... 121
6.4.5. MO13372 - Rotor motor................................................................................................................... 123
6.4.6. MO13376 - Filter drum motor / AC13375 - Filter drum.................................................................. 125
6.5. Electronic systems.....................................................................................................127
6.5.1. PC13385 - XYZ interface board...................................................................................................... 127
6.5.2. PC13386 - Microprocessor board / PC13383 - DC / DC board..................................................... 128
6.5.3. TR13389 - Main power supply / AC17324 - Refrigerator power supply...................................... 129
6.5.4. AC17323 - Electronic refrigerator plate......................................................................................... 130
6.5.5. PC13384 - Communications board................................................................................................ 131
6.5.6. PC13381 - Plate of the photometric system.................................................................................. 131
6.5.7. PC13387 - Pump interconnection plate......................................................................................... 133
6.6. Refrigerador de reactivos..........................................................................................134
6.6.1. Led status indicator and refrigerator lid sensor........................................................................... 134
6.6.2. AC17320 - Refrigerator Peltiers / AC17321 - Refrigerator fan...................................................... 134
6.6.3. AC17319 - Refrigerator temperature sensor................................................................................. 137
7. Preventive maintenance............................................................. 138
7.1. Maintenance and periodicity actions........................................................................138
7.2. Care and cleaning.......................................................................................................139
7.2.1. General care of the analyzer........................................................................................................... 139
7.2.2. Cleaning the optical system........................................................................................................... 139
7.2.3. Cleaning the dispensing system.................................................................................................... 140
7.2.4. General cleaning of the interior of the apparatus........................................................................ 140
7.2.5. Cleaning the reagent cooler........................................................................................................... 140
7.2.6. Process of analyser verification.................................................................................................... 140
7.2.6.1. Material needed....................................................................................................................... 140
7.2.6.2. Process of the verification...................................................................................................... 141
AI. Technical specifications........................................................... 146
7
Service manual

AII. Adjustment margins tables..................................................... 150


AIII. List of consumables, accessories and spares .................... 152
AIV. Software versions................................................................... 163
AV. Refurbish instructions............................................................. 168
AVI. Removal of instrument from use for repair or disposal of
waste............................................................................................... 169

8
Persons for whom this manual is intended
This manual is intended for professionals belonging to the technical service who perform preventive maintenance
tasks on and repair the A15, A15C, Y15 and Y15C analyser. These professionals will have received special training
enabling them to perform the above-described tasks.
This manual describes the mechanical and electronic characteristics and service software to assist technicians in
performing maintenance and repair work. It also describes the steps for disassembling and changing the different
elements that comprise the analyser.

Notices and warnings


Explanation of the safety symbols located on the analyser or in this manual.

Symbol Description
The symbol warns of operating risks that could cause personal
injury.

WARNING
The symbol warns of a potential biological hazard.

BIOHAZARD
The symbols warns of potential damage to the system or unreliable
results.

CAUTION
The symbol warns that the information requires your attention.

NOTE
Risk of electric shock.

Explanations of the symbols used on the analyser labels and in the manual
Symbol Description
This product is compliant with European union directive

Medical device for In Vitro Diagnostics.

Please consult the directions for use.

Serial number

9
Service manual

Symbol Description
Expiry date

Batch code

Catalogue number

Temperature limit

Manufacturer

Irritant

Caution, Possible biological and chemical spill

Fragile, symbol used on the packaging

Keep upright, symbol used on the packaging

Keep dry, symbol used on the packaging

Safety precautions
Symbol Description
Preventing electric shock
To prevent the risk of electrocution. Do not remove any of the analyser
housing elements. No user intervention makes it necessary to access the
parts inside the equipment. If necessary, contact the technical assistance
service.
Preventing biological risks in handling the samples
Inappropriate handling of samples, controls and calibrators could cause
biological infection. Do not touch the samples, mixtures or waste with your
hands. Wear gloves and protective clothing when necessary.
In the event that the samples come into contact with the skin, wash
BIOHAZARD
immediately with abundant water and seek medical advice. It is advisable
to follow good laboratory practices.

10
Symbol Description
Prevention in handling reagents
Handle reagents and washing solutions with care, they contain substances
that could be corrosive.
In the event that the reagents or washing solutions come into contact with
WARNING the skin, wash immediately with abundant water and in the event of a
reaction, seek medical advice.
Consult the reagent or washing solution adaptation sheet and follow the
safety instructions.
It is advisable to follow good laboratory practices.
Preventing biological risks in handling solid waste
Take care in handling parts of the analyser that are converted to waste
such as the reactor rotor, sample tubes and reagent bottles.
Wear gloves and protective clothing when handling such waste.
BIOHAZARD Dispose of the waste in accordance with national or local legislation
for disposing of dangerous biological waste, and consult the reagent
manufacturer or distributor for more details.
Prevention of electro magnetic interferences
The analyser complies with the emission and immunity requirements
set out in standard UNE-EN 61326-2-6:2006. This equipment has been
designed and tested for class B of standard UNE-EN 55022:2000. In a
NOTE domestic environment, it may cause radio interference, in which case it
may be necessary to take measures to mitigate the interference.
Do not use the analyser near strong electro magnetic radiation sources
(such as centrifuge appliances, radio transmitters, mobile telephones), as
they could interfere with its correct operation.
Prevention at the end of the useful life of the analyser
At the end of the useful life of the analyser, the product must be disposed
of in accordance with the environmental legislation in force in each country.
If that country is a EU member state, the terms of the WEEE directive on
electrical and electronic appliances will apply. In other words, when the
appliance's useful life has ended, it is converted into waste and must be
separated from household waste for correct recycling. For this purpose,
contact the distributor for the product to be properly recycled.
Prevention when deactivating the cover sensor
The option to deactivate the covers sensor only serves to facilitate the
technical service that can carry out maintenance or repair actions. Once
the maintenance or repair is finished, the technician has to reactivate the
NOTE covers’ sensor again. The covers’ sensor are elements of security of the
analyzer.
Safety prevention for technical assistance service personnel
Wear gloves and protective clothing to manipulate the analyzer.
Before performing any manipulation, empty the analyzer of biological
material: samples, deposits, etc.
NOTE Be cautious when you have to repair analyzer points that have dangerous
voltages such as parts related to the power supplies.
Use caution when handling points that have contact with biological
material, such as tips, pipes and fittings where highly contaminated waste
flows.
Be sure to follow the instructions in the manual when you have to replace
parts or perform maintenance to ensure the safety of the service personnel
as well as the operator once the repair is complete.

11
Service manual

Symbol Description
Spare network cables
If you are going to use a network cable that is not supplied by the manufacturer,
make sure that it supports the power of the analyzer, that it is approved and
that it complies with the CE regulations.
NOTE
Operations after a repair
After a repair make sure that you have replaced all the disassembled parts
following the relevant instructions and that you have carried out the verification
tests with the service program.
NOTE
Use of consumables
Before using the consumables (cleaning solutions and system fluids) check
the expiration date. If it has expired, remove the product and use a new one
with the current expiration date.
NOTE
Operations that may compromise the safety of the equipment
Any misuse (negligence, power conditions out of tolerance, inappropriate
location or atmospheric conditions, etc.) together with internal manipulation
of the instrument by personnel not authorised by BioSystems or the use of
NOTE unoriginal consumables and spares (tubes, fuses, etc.) shall compromise
the protection assured by the analyzer.

Representations of screens shown in this manual are for illustrative purposes only. The screens do not necessarily
reflect valid data.

Abbreviations and units shown in the manual


Abbreviation Definition
∅ Diameter
EC European Community
EMC Electromagnetic compatibility
CRTL Control key on the computer keyboard
EN European norm
F Fast (fuse type)
FUS Fuse
IVD In Vitro Diagnostics
LED Light-emitting diode
LIS Laboratory information system
WEEE Waste Electrical and Electronic
Equipment
REF Reference solution for the ISE unit
TAS Technical assistance service
SD Standard deviation
ES Electrical safety
UV Ultraviolet

12
Units Definition
" Inch
˚C Degrees centigrade
A Ampere / Absorbance
GB Gigabyte
h Hour
Hz Hertz
kg Kilogram
L Liter
MB Megabyte
m Meter
min Minute
mL Milliliter
mm Millimeter
mmol Millimole
mV Millivolt
nm Nanometer
Nm Newton Meter
prep Preparation
s Second
VA Volt-ampere
V Volt
W Watt
μL Microliter
μm Micrometer

Software usage licence


BIOSYSTEMS, the exclusive owner of all the rights over this computer application, grants one non-transferable, non-
exclusive licence governing the use of the computer application to the user, who accepts it solely and exclusively for
executing this computer application in a single central processing unit (CPU) of a computer.
This licence does not permit the execution, use, access, reproduction, transformation, translation, lease, sale, distri-
bution, commercial exploitation or provision to third parties in any way, and above all in a computer network or through
remote access technologies, of all or part of the content included in this DVD.
BIOSYSTEMS will in no case be liable or assume payment of any compensation whatsoever:
with respect to any infringement of the intellectual and/or industrial property rights of others caused by copying images,
audio and/or text as part of the content of this DVD;
due to the exhaustiveness or accuracy of the data incorporated through incorrect use of the computer application in
the DVD;
for damages, losses or indirect, special, incidental or consequential damages to people or property due to the incorrect
use or putting into practice of any of the methods, theories, products, instructions, ideas or recommendations included
in this DVD or which make reference to its content.
The computer application in this DVD is delivered with no guarantee of the results obtained following incorrect use
or adaptation for a specific purpose. The user fully assumes all risks with regard to the results obtained by incorrect
use of the computer application.
None of the contents of this usage licence grants the user any intellectual or industrial property rights or rights over
the confidential information of BIOSYSTEMS and/or of persons with rights over the content of this DVD.

13
Service manual

The licence granted and constituted pursuant to these terms and conditions will be interpreted in accordance with
and governed by Spanish law, with the jurisdiction being the courts of the city of Barcelona, Spain. The user waives
any other applicable legislation and/or jurisdiction that is competent, if any.
The user of this licence knows and agrees that the user licence grants no rights over the use of computer program-
mes and/or applications belonging to others that may be used or which may be necessary for using or operating this
computer application, for which the user will obtain the respective legitimisation of use.

1. Intended use
• The A15/A15C analyser is used to determine analyte concentrations by in vitro biochemical, turbidimetric and
electrolyte measurements of human samples of serum, urine, plasma, cerebrospinal fluid or total blood.
The A15/A15C analyser has been optimised to operate with the BioSystems biochemistry, turbidimetric and elec-
trolyte reagent lines. Reagents not included in the A15/A15C analyser validation performed in BioSystems SA
require a complete and detailed validation by the user or the laboratory.
Users are strongly advised to validate the overall functioning of the analyser and of the reagents in the laboratory,
taking into consideration the preanalytical phase and all other relevant aspects.
The analyser is exclusively for professional use, i.e., for users who have the appropriate training and expertise
to use it. In addition to how to install the instrument, users are instructed on how to use the analyser and the
software that goes with it.
The environmental conditions for the functioning of the analyser are normal clinical analysis laboratory conditions.
These conditions are set out in the specifications chapter.

• The Y15/Y15C analyzer is used to determine analyte concentrations in wines, beverages, food and samples of
biological cultures through biochemical analysis.
The Y15/Y15C analyzer is optimized to work with the BioSystems line of FoodQuality reagents. Reagents not
included in the Y15/Y15C validation performed in BioSystems S.A., will require thorough and detailed validation
by the user or laboratory.
It is strongly recommended to validate the overall performance of the analyzer and the reagents in the laboratory
setting, taking into account the preanalytical phase and any other relevant aspect.
The analyser is exclusively for professional use, i.e., for users who have the appropriate training and expertise
to use it. In addition to how to install the instrument, users are instructed on how to use the analyser and the
software that goes with it.
The environmental conditions for the functioning of the analyser are normal analysis laboratory conditions. These
conditions are described in the specifications chapter.

14
2. Introduction
The A15 analyzer is an automatic random access analyser specially designed for performing biochemical and turbi-
dimetric clinical analyses. The instrument is controlled on-line in real time from an external dedicated PC.
A15C model has also a cooler reagents.
Y15 analyzer is an automatic random access analyzer derived from A15 is specially suitable for safe food analyses.
The Y15C has also an coller reagents.
The A15 and A15C analyzer can also be used for the measurement of stool analytes. Chapter 1.4 shows how to
modify the analyzer to determine stool analytes.
In each of the elements of the A15 analyser, BioSystems has used leading edge tech­nology to obtain optimum ana-
lytical performance, as well as taking into account eco­no­my, robustness, easy use and maintenance. A three-axis
Cartesian operating arm prepares the reactions. Dispensing is performed by means of a pump with a ceramic piston
via a detachable thermostated needle. A washing station guarantees that the needle is kept perfectly clean through-
out the process. The reactions take place in a thermostated rotor in which absorbance readings are taken directly by
means of an integrated optical system.

This manual contains the information required for learning about, maintaining and repairing the A15 automatic analy-
zer. It should be used by the Technical Service ­as a learning and consultation docu­ment for the maintenance and
repair of the instru­ment. Chapter 2 describes the different mechanical elements that form the analyzer together with
their functionality, and chapter 3 describes the electronic system. Chapter 4 describes the Service Program. All the
adjustments and checks of the analy­zer are carried out through this program, which is independent from the appli­cation
program (User Program). The separation of both programs enable it to be maintai­ned separately and the extensions
and improvements of one do not affect the other. The user does not have the service program. The Technical Service
must install it on the user’s computer in order to carry out the service requirements. Once said tasks have been carried
out, the Technical Service must uninstall the program. Chapter 5 offers instructions for the different mainte­nance,
rep­air and cleaning operations that can be carried out by the Technical Service. The annexes contain a summary of
the technical specifications of the analyzer, the adjustment margin tables, the lists of accessories and spares, a list
of software versions and their compatibility and a software troubleshooting guide.

2.1. General description of the analyzer


The A15 analyser is made up of three basic elements: the operating arm, the dispensing system and the reading and
reactions rotor. The electronic system of the instrument controls said elements and communicates with the external
computer containing the application program. Through this program, the user can control all the operations of the
analyzer.
15
Service manual

2.1.1. Operating arm

This is a three-axis XYZ Cartesian mechanism. The X and Y axes move the dis­pens­ing needle over the analyser
horizontally and the Z axis moves it vertically. It is operated by three step-by-step motors. In each 24-second prepara-
tion cycle, the operating arm performs the following actions: first of all, it sucks in the reagent from the corresponding
bottle. Next, the needle is washed externally in the washing station and sucks in the sample from the corresponding
tube. It is washed externally again and dispenses the sample and the reagent into the reactions rotor. Finally, it is
exhaustively washed internally and externally before proceeding with the next preparation. The arm has a system
for controlling vertical movement to detect whether or not the needle has collided into anything on descending. If a
collision occurs, as may be the case if, for example, a lid has been left on a bottle of reagent, the arm automatically
restarts, verifies the straightness of the needle and continues working issuing the corresponding alert to the user.
A vertical axis retention system prevents the needle from falling in the case of a power cut, avoiding injury from the
needle to the user or the needle being bent by an attempt to move the arm manually. The operating arm only makes
the preparations if the general cover of the analyser is closed. If the cover is raised while it is functioning, the arm
automati­cally aborts the task in progress and returns to its parked position to avoid injury to the user.

2.1.2. Dispensing system

This system consists of a thermostated needle, supported and displaced by an operating arm and conne­ct­ed to a
dispensing pump. The needle is detachable to enable cleaning and replacement. The analyser has capacity level
detection to control the level of the bottles and tubes and prevent the needle from penetrating too far into the corre-
sponding liquids, thus minimising contamination. An automatic adjustment system informs the user if the needle is not
mounted or if it is too bent. The needle has a sophisticated Peltier thermos­tatation system, with PID control, capable
of thermostating the preparations at approximately 37º in less than 15 seconds. Dispensing is carried out by means
of a low maintenance ceramic piston pump driven by a step-by-step motor. It is capable of dispensing between 3 and
1250 ml. The exterior of the needle is kept cons­tantly clean by a wash station included in the base. A membrane pump
transports the waste to the corresponding container.
The A15 analyser has a tray with 4 free positions for racks of reag­e­nts or samples. Each reagents rack can carry up
to 10 reagents in 20 ml or 50 ml bottles. Each samples rack can contain up to 24 tubes of samples. The samples can
be patients, calibrators or controls. The analyser can be configured to work with 13 mm or 15 mm diameter tubes of
samples with a length of up to 100 mm or with paediatric wells. Any possible configuration of racks can be mounted
from 1 rack of reagents (10 reagents) and 3 racks of samples (72 samples) to 3 racks of reagents (30 reagents) and
1 rack of samples (24 samples).
On the left of the analyser are the waste and distilled water containers. The analyser constantly controls the level of
these containers and issues the appropriate alerts if the distilled water is nearly empty or if the waste container is full.

16
The A15C/Y15C versión has a cooler. This cooler has two fixed racks. The first rack can contain up to 10 reagent
containers of 20 mL. The second one can contain 10 reagent containers of 50 mL. Each of these possitions can use
conatiners of 20 ml but not both.

2.1.3. Reactions rotor and reading

The preparations are dispensed in an optical quality methacrylate reactions rotor thermos­tated at 37ºC. The optical
absorbance readings are taken directly on this rotor. Each reaction can be read for 10 minutes. The readings are
taken as they are programmed in each measurement procedure. The reaction wells have been designed to enable
the mixture of the sample and the reagent during the dispensing. Each rotor has 120 reaction wells. The length of the
light path is 6 mm. The minimum volume required to take the optical reading is 200 uL. The wells have a maximum
useful capacity of 800 uL. When the reactions rotor is completely full, the user must change it for one that is empty,
clean and dry. The rotor is driv­en by a step-by-step motor with a transmission. A Peltier system with PID control ther-
mostates the rotor at 37ºC.

17
Service manual

An optical system integrated in the rotor takes the readings directly on the reaction wells. The light source is a 10 W
halogen lamp. The detector is a silicon photodiode. The wavelength is selected by a drum with 9 positions available
for optic filters. The filters are easily ch­an­ged by the user from the exterior of the analyser, without the need for disas-
sembling the filter drum. A step-by-step motor positions the drum. The optical system is capable of taking 1.25 readings
per second, with or without a filter change in between. The light beam from the lamp passes through a compensated
interferential filter to select the desired wavelength. It then passes through the rotor well and finally reaches the pho-
todiode, where the light signal is turned into an electric signal. A sophisticated analogical digital integrator-converter
system converts the electric signal into a digital value with which the analyser obtains the absorbance values. The
optical system continues to work when the general cover of the ana­lyser is open, whereby the analyser can continue
to take readings while the user handles, for example, the sample tubes or the reagent bottles. The rotor cover must
be ­in place­for the optical system to work correctly.
A detector tells the analyser of the presence of the cover. The analyser aborts the readi­ngs if the user removes the
rotor cover while the optical system is taking photometric measurements. If the rotor is not covered, the analyser
informs the user so that he or she places the rotor cover when it sends samples to be analyzed.

2.1.4. Electronic system

The described elements are controlled by an electronic system based on a micropro­cessor. The microprocessor has
two exter­nal communication channels to connect the instrument to the computer containing the application pro­gram.
The electronic system is made up of the following independent boards:
• Microprocessor board
• Photometric system board
• Needle conditioning board
• Fluid system interconnection board
• Arm interconnection board
• Rotor interconnection board
• Power supply board
• Refrigerator control board (only A15C / Y15C models)

2.1.5. Application program

The application program makes it possible to control all the operations of the analy­zer. Fro­m this program, the user
can monitor the state of the analyzer and the work session, program parameters, e.g. technique parameters, prepare
the work session, prepare results reports, configure different analyzer options, activate various test utilities, prepare
and maintain the instrument and carry out internal quality control processes. The purpose of this manual is not to
explain the fun­ction­ing of the user program. For detailed information to this re­gard, please con­sult the User Manual
included with the analyzer.

18
2.2. Functioning of the analyser
The A15 analyser is an automatic random access analyser specially designed for performing biochemical and turbi-
dimetric clinical analyses. The analyser performs patient-by-patient analyses and enables the continual introduction
of samples. The analyser is controlled from a dedicated PC that is permanently com­muni­cated to the instrument.
The programme, installed on the computer, keeps the user constantly informed of the status of the analyser and the
progress of the analyses. As results are obtained, the com­pu­ter shows them to the user immediately.
When a Work Session is begun, the ana­ly­ser proposes performing the blanks, calibra­tors and controls programmed
for the measurement procedures it is to carry out. The user may choose between performing the blanks and the
calibra­tors or not. If they are not performed, the analyser uses the last available memorised data. The controls can
also be activated or not. During a session, while the analyser is working, the user can introduce new normal or urgent
samples to be analyzed. Each time a new sample is added, the analyser automa­tical­ly proposes the possible new
blanks, calibrators or controls to be performed. A work session can remain open for one or more days. When a session
is closed and another new session is opened (Reset Session), the analyser again proposes performing the blanks,
calibrators and controls. It is recommended that the session is reset each working day.
The analyser determines the concentrations of the analytes based on optical absorbance measurements. To measure
the concentration of a certain analyte in a sample, the analyser uses a pipette to take a specific volume of the sample
and the corresponding reagent, quickly thermostates them in the needle itself and dispenses them into the reactions
rotor. The very dispensing speed together with the geometry of the reaction well causes the mixture to be shaken and
the chemical reaction begins. In the bireagent modes, the reaction begins when the analyser later dispenses a second
reagent in the same reaction well. The reactions can be biochemical or turbidimetric. In both cases, the reaction or
the chain of reactions produced generate substances that attenuate certain wave­len­gths, either by absorption or by
dispersion. Comparing the light in­ten­sity of a certain wavelength that crosses a well when there is a reaction and when
there is not a reaction can determine the concentration of the corresponding analyte. This comparison is quantified
with the physical magnitude called absorbance. In some cases, the concentration is a direct function of the absorb-
ance, and in other cases, it is a function of the variation of the absorbance over time, depending on the analysis mode.

2.3. Transport and reshipment of the analyzer


If the analyser is to be reshipped or moved using a transport vehicle, it is important to block the operating arm and
use the original packaging to ensure that the apparatus is not damaged. To package the instrument, we recommend
you follow the following instructions: (on the unpackaging instruc­tions sheet)

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Service manual

Unlock the arm mechanism removing


the screw (1).

1 2 3

To unlock the arm mechanisms re-


move the foams (1) , (2) and (3).

2.4. Analyzer modifications to analyze stool analytes


The analyzer A15 and A15C can be converted to perform determinations of stool analytes.
The main difference for measuring stool analytes is the primary tube that contains the sample. It is a special tube that
serves for the collection of the sample and to perform the pretreatment.
To use this primary tube, it is necessary to make the following modifications to the equipment:
• Change of tip to be able to pierce the seal, operculum, of the stool tube
• Install Firmware version v6.16 or higher
• Install the A15 STL user software. A new tube type model has been incorporated.
• Install the service program version v4.2.2
20
• Perform the positioning adjustment for the new tube type (STOOL). In chapter 4.2.3.4 indicates how to perform
the new adjustment.
• Perform sensitivity adjustment for the new type of stool collection tube. In chapter 4.2.7 indicates how to make
the adjustment.

The replacement codes of the elements to be replaced are:


AC17342 A15 Tip to determine the stool analytes
AC17343 Stool A15 CD user program

If you are going to use the analyzer to measure stool analytes, do not mix the different sample types in the same
analyzer.
The tip for the determination of the stool analytes is special since it ends in a sharp point to pierce
the operculum of the primary tube.
Be very careful when performing maintenance and / or repair operations that are related to the tip.
BIOHAZARD Pay attention a lot when handling or readjust the tip in not puncturing. The tip can be potentially
infectious. Wear gloves and protective clothing when handling the tip.

21
Service manual

3. Mechanical elements

3.1. Part of the instrument

The physical structure of the analyzer can be broken down as follows:

• Operating arm
• X guide
• Y guide
• X carriage
• Y carriage
• Needle unit

• Dispensing system
• Thermostated probe
• Dispensing pump
• Tubes and containers
• Container level control sensors
• Racks tray with integrated washing station
• Waste pump
• Reactions rotor with integrated optical system
• Thermostated rotor and photometric system. This contains the electronic photo­metric system board
• Lighting system
• Electronics box.This houses the electronic boards of the microprocessor, the power sup­ply and the front indicator
• Main cover hinges
• Base
• Housings
• Upper casing
• Front housing
• Arm casing
• Main cover

The following is a brief description of each of the mechanical elements that make up the analyzer.

3.2. Description of the mechanical elements

3.2.1. Operating arm

This mechanism positions the dis­pen­sing needle appropriately during the prepara­tion of the analyses. An encoder
checks the vertical movement of the needle and a spring automatically stops it from falling in the case of a power cut.
The dispen­sing pipe and the electrical hoses of the arm pass through the front casing
22
Reference to the Ilustration 3.1
1 – Axis control board 6 – Axis support
2 – Photodetector X position 7 – Bottom X bearing
3 – X Carriage 8 – Lower X axis
4 – X Motor
5 – Upper toothed X axis

The needle unit (5) supports the thermostated needle and can move on the Y carriage (3), which can move on the
Y axes (4). The Y axes are supported by the X carriage, which moves on the X axes (1). In this way, the needle can
be moved in the three Cartesian directions of X, Y and Z. The hose (6) houses the Teflon dispensing tube and all the
electrical ho­se­s of the arm.

3
4

Ilustration 3.1. X axe set

This consists of two supports (7) that hold the steel axes (1 and 2) on which the X carriage moves. The photosensor
(3) indicates the start position of the X carriage movement. The motor X (5) is moved by a rack (2). The X carriage is
supported by the second axis (2) by means of a bearing (4).
The X carriage body (1) moves along the two axes (2, 3). The upper axis (2) acts as a rack. The X motor (4) is fitted
with a pinion that moves the carriage. The X carriage also supports the interconnection PCB (7) and the Z motor (5).
To enable the movement, it uses linear bearings (8).
The body of the Y carriage (1) moves along the two axes (2) on linear bearings (9). The said axes are supported by
the X carriage. The movement is made by the Y motor (3) by the belt (4) and the return pulley (5). The start of the
movement is controlled by the tab (7) and the start photosensor (6) located on the X carriage (10). The body of the Y
carriage (1) also supports the needle unit.

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Service manual

9 10
11

12

13

14

Ilustration 3.2. Y axis

Reference to the Ilustration 3.2


9 – Start Y detector 12 – Z motor
10 – Y belt 13 – Collision detector
11 – Y motor 14 – Y Axis

3.2.2. Needle unit

The Z guide (1) supports the thermostatation pipe (7) and the control PCB (8) where the heating elements are located,
together with the thermistor signal amplifier and level detection and the Z axis start photosensor. The rack (2) supports
the Z guide (1) which crosses the Y carriage (9) on two bearings. The Z motor (3) is fastened to the X carriage (10)
and is moved by a transmission axis (5) fitted with a pinion that acts on the rack. The return spring (6) acts on the
transmission axis and prevents the needle from falling in the event of a power cut: The encoder (4), which detects any
obstruction to the movement of the thermostated needle (9) is located on the same axis and on the part of the motor.

Reference to the Ilustración 3.3


15 – Thermostatic tube 19 – Return spring
16 – Z axis 20 – Z axis start photodetector
17 – Y bearing 21 – Probe
18 – Counter pulley Y

The thermostatation pipe (1) preheats the reagent during dispensing. It is fitted with two connectors at each end. The
removable needle (6) is connected to one and the Teflon dispensing pipe (3) is connected to the other, fixed by the
fastening connector (5). The PCB (2) contains the thermostatation elements, the thermistor and associated circuits.
The various thermistor and element action signals (3) pass through the hose (4).

24
15 16 17 18

19

20

21

Ilustration 3.3. Z axis

3.3. Dispensing system


The dispensing pump dispenses the preparations through the thermostated needle. The needle is washed internally
and exter­nally at the washing station. The racks tray makes it possible to position the samples to be analyzed and
the required re­a­gents. The level of the distilled water and waste containers is controlled by the analyzer by capacity.

3.3.1. Dispensing pump

The plastic body (1) joins the different elements that make up the pump. The transparent methacrylate fluidic cham-
ber (2) or the manifold (1&makes it possible to observe the flow of liquid through the pump. The support (4) fastens
the seal (3). The ceramic piston (5) dispenses by displacing a certain volume of liquid in the chamber. The piston is
adhered to the support (6), which moves alternatively by the rotation of the endless screw (9) fixed to the motor axle
(10). The barrier (7), joined to the piston support, obstructs the photosensor (11) when the piston reaches its start
position. The axial bearing (8) prevents any longitudinal displacement of the motor axle for greater precision in the
dispensing operation. The 3-channel electrovalve (14) makes it possible to connect the pump chamber to the distilled
water container or to the thermostated needle. The Teflon tube (13) connects the chamber to the electrovalve. It is
connected to each of these elements by the nuts (13) and (15).

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Service manual

22

23

Ilustration 3.4. Position of the ceramic pump

24

25

36

26

27

28

Ilustration 3.5. Ceramic pump connections

26
29

30
31
32
33

34
35

28

Ilustration 3.6. Ceramic pump detail

Reference to the Ilustración 3.4, Ilustración 3.5 and Ilustration 3.6

22 – Manifold 30 – Dispensing chamber


23 – Ceramic pump 31 – Catch
24 – Internal interconnect tube 32 – Ceramic piston
25 – Pump-Tip Interconnect Tube 33 – Spindle
26 – Interconnection tube for liquid bottle of system - pump 34 – Anti-twist aixial bearing
27 – Startup photodetector 35 – Motor shaft
28 – Pump motor 36 – Manifold solenoid valve
29 – Manifold methacrylate

3.3.2. Tubes and containers

The Teflon tube (4) connects the distilled water container (1) to the electrovalve of the dispensing pump. This tube is
installed at the end of the filter container (5). It is connected to the electrovalve of the dispensing pump through the nut
(6) The Teflon pipe passes through the rubber piece (3) in the lid (2) of the container, which fastens them in position.
The PVC tube (12) connects the waste extraction membrane pump to the waste container (9). The waste container
lid (19) has a fast coupling nut (11) with automatic drip-proof closing when disconnected. All the tubes pass into the
interior of the analyzer through the rubber grommet (13).

27
Service manual

47
46
37

38
39

40

41

42

43

44
45

Ilustration 3.7. Connections for waste bottles and system liquid

Reference to the Ilustration 3.7 y Ilustración 3.8


37 – Waste PCV tube 46 – Quick drip-free waste fitting
38 – Level detection rod for waste bottle 47 – Grommet
39 – System liquid bottle 48 – Instrument base and washing station
40 – Teflon tube for suction of system liquid 49 – Overflow tube
41 – Level detection rod for the system liquid bottle 50 – Sink tube
42 – Waste aspiration pump 51 – Tube connecting to the waste pump
43 – PVC tube connecting the waste from the washing
station to the suction pump
44 – System fluid inlet filter
45 – Reference board for level detection

3.3.3. Container level control sensors.

The analyzer has a capacitance system to control the level of the distilled water and waste containers. For this, there
is an emission plane (1) under the bottles where a signal is injected through the connector (2). The base supporting
the bottles is above this. They have 2 rods that collect the signal and indicate the presence or absence of liquid.

3.3.4. Racks tray with integrated washing station.

The plastic injection tray (1) is part of the base of the instrument. The washing station (2) is installed on the right.
The plate (3) detects the level of the dispensing needle. The PVC tube (4) connects the washing station drain to the
waste extraction pump.

28
48

49

50

51

Ilustration 3.8. Connecting the tubes of the washing station

3.3.5. Washing pumps

The needle washing system has a waste extraction pump (1). This is connected to the washing station by the PVC (2).
The pump expels the waste through the pipe (4) into the waste bottle. The pipes are fastened by two safety flanges.

3.4. Reaction rotor with integrated optical system.


The reactions rotor is thermostated at 37ºC. The optical system, made up of a lighting system and a photometric
system takes the readings directly on the rotor reaction wells. The lighting system has a halogen lamp, a filter drum
for the selection of the wavelength form the appropriate beam of light. The photometric system contains a silicon pho-
todiode and the corresponding electronics to obtain a digital value that is proportionate to the light intensity received.

3.4.1. Thermostated rotor and photometric system

The dispensing system dispenses the reagents and the samples in the methacrylate rotor (1). The optical system
measures the absorbance directly on the rotor wells. The aluminium heating canal (2) surrounds the rotor and keeps it
at 37ºC. The canal is thermally insulated from the exterior by means of the moulded expanded polystyrene insulation
(3). The Peltier cells (4), with their respective radiators (5) and fans, act on the canal to control the temperature. The
sensor used to control the temperature is the probe (7). The methacrylate rotor is fastened to its centring unit (8) by
means of the screw (9). The centring unit is fixed to the heating canal through the axis (22), which is fitted on bearings
(11). The barrier obstructing the photosensor (10) when the rotor reaches its start position forms part of the centring
unit (8). The centring unit also acts as gearing. The pinion (12), fixed to the motor (13), acts through the crown (14),
which also acts as a centring unit. The separator (15) does not allow the motor temperature to reach the heating canal.
The electronic board of the photometric system (16) is housed in a cavity in the heating canal. The upper cover of this
cavity (17) supports the electronic board. The seal (18) keeps the cavity hermetically closed in the case of possible
liquid spillage. The housing of the filter drum is closed at the bottom by the cover (18). The part (19) centres the pho-
todiode with regard to the lighting system and also acts as a grill to prevent the incidence of unwanted light. The grill
(20) limits the light hitting the reactions rotor. The detector (21) tells the analyzer if the rotor cover is in position or not.

29
Service manual

3.4.2. Lighting system

The aluminium body (1) is the structure that supports all the elements of the lighting system. The lamp holder (2),
fastened to the body by means of the fastening system (4), keeps the halogen lamp (3) in position without the need
for adjustments. The filter drum (5) has 10 positions for optical filters. Position 0 must always be taken up by a cove-
red filter. The other positions can be taken up by an interferential filter (8) or by other covered filters. No position in
the drum must be left unoccupied. Each filter is fitted on a filter holder (6) and fastened to it by the nut (7). The filter
holders can be dismounted from the drum by simply pulling on them. The cover (13) allows easy access to the filter
drum. The filter drum is fastened to the axle (9). This axle can be turned by the direct action of the motor (11). Its end
is guided by the bearing (14). The photosensor (10) indicates the start position of the drum. The light from the lamp,
limited by the diaphragm (12). The light passes through the filter drum, which selects the desired wavelength, and
through the aperture(15), which adapt the form of the light beam to the geometry of the rotor wells.

1
9
2
3
12
13

11
8

22

20 19 16 17

Ilustration 3.9. Reaction rotor set

30
3

18

13

15

10

14

21
7

Ilustration 3.10. Internal display of the reaction rotor

31
Service manual

Reference of the Ilustración 3.9 Ilustration 3.10 y Ilustration 3.11


1 – Methacrylate rotor 21 – Cover Detector
2 – Heating channel 22 – Rotor shaft
3 – Thermal insulation of the heating channel 23 – Lampholder
4 – Peltier cells 24 – Halogen lamp
5 – Radiators 25 – Fixing the lamp holder
6 – Fans 26 – Filter drum
7 – Temperature probe 27 – Filter holder
8 – Rotor centering 28 – Filter holder nut
9 – Rotor fixing screw 29 – Interference compensated filters
10 – Rotor start photodetector 30 – Filter drum shaft
11 – Bearings 31 – Startup photodetector
12 – Pinion gear 32 – Filter drum motor
13 – Rotor motor 33 – Diaphragm
14 – Rotor crown gear 34 – Filter Drum Shaft Bearing
15 – Motor spacer 35 – Fitlros drum start photodetector
16 – Photometric system board 36 – Diaphragm
17 – Electronic board support cover 37 – Slit
18 – Optics cap
19 – Photodiode slit centering device
20 – Rotor slit

32 2 24 25 30 23

37

36
35
31

34

26
29
27
28

Ilustration 3.11. Optics

3.4.3. Housing and covers

The base (2) on which all the elements of the analyser are fixed is fastened directly to the lower plastic casing. The
rack tray and washing station form part of the base. The instrument stands on 4 rubber legs . The front right leg (13)
is adjustable in height to adapt the instrument to the work surface.
The front casing (1) is fastened to the upper casing (2) and the upper casing is fastened to the lower casing (4). The
32
top cover (3) is transparent and lets users see the analyser in operation with the cover closed.
The metal cover (1) supports the mains switch (2) and the fuse holders (3), as well as the identification label (4). The
COM1 and COM2 connectors (6, 7) and the mains connector (5) are fastened to the electronics box. The cover(1)
opens on 2 hinges (7).
The two hinges enabling the raising of the main cover of the analyzer consist of an articulated steel structure (2)
operated by a hydro-pneumatic spring (1). The right-hand hinge includes a photosensor (3) to detect whether or not
the cover of the analyzer is open or closed.

5
6
7
8
9
10

Ilustration 3.12. Covers

33
Service manual

11

12

13
14

15 16 20 21

Ilustration 3.13. Back plate

22

17

18

19

Ilustration 3.14. Hinge detail

34
Referencias de la Ilustration 3.12, Ilustration 3.13 y Ilustration 3.14
1 – Top cover 12 – Fridge switch
2 – Upper housing 13 – Fuses
3 – Arm housing 14 – Plug
4 – Front arm protector 15 – Main connection
5 – Front housing 16 – Auxiliary connection
6 – Reaction rotor cover 17 – Cover detector plate
7 – Fridge cover 18 – Cover Detector
8 – Bottom housing 19 – Hydro-pneumatic piston
9 – Fridge housing 20 – Back plate
10 – Leg 21 – Identification label
11 – Analyzer switch 22 – Top cap support structure

3.4.4. Reagents cooler

The plate (12) is cooled by the peltier cells (6). These are refrigerated by the heatsinks (5) and fans (4). A temperatu-
re sensor(10) is connected to electronics module that controls the temperature. The isolators (9) in the housing (2)
avoid that the flux heat enters inside of cooler. A lid sensor (8) informs to analizer if lthe lid is seated. The lid sensor
is serial connected with the general lid of analizer.

12
9

10

Ilustration 3.15. Refrigerador details

35
Service manual

4. Electronic system

4.1. Description of the electronics of the A15 analyzer.

The electronics of the analyzer are made up of different boards located at different points in the analyzer and dedica-
ted to specific functions. Its different location corresponds to functionality and performance criteria for the functioning
of the analyzer.

There are 8 different boards, which correspond to:

• CPU Board (CIIM00026)


• Power supply board and source (SP150 & CIIM00015)
• Needle Board (CIIM00017)
• Photometry Board (CIIM00027)
• XYZ carriage interconnection board (CIIM00018)
• Rotor interconnection board (CIIM00029)
• Fluid interconnection board (CIIM00028)
• Communications Board (CIIM000)
• Reagents cooler board (CIIM00075)

4.2. CPU Board (CIIM00026)

This is the brain of the machine, containing the microprocessor (H8/3003), responsible for controlling all the elements
of the machine. The board has different data storage systems using either static RAM (U1 and U47), FLASH memory
(U10) or EPROM (U9). The slot associated with the EPROM is used to check the functionality of the board and the
recording of the MONITOR program in the production phases of the analyzer. The other two memories are associated
with the normal functioning of the analyzer. The FLASH memory holds the application itself as well as different data-
bases related to factory settings, adjustments, state of the rotor and possible extensions to the application.

The U21 device also exists on the board. This is a logical programmable device (FPGA) dedicated to the control of
motors, mapped in register memory associated with end-of-run control, electrovalves, level sensing and control of the
photometry-associated board (CIIM00027).

The motor control acts directly on the drivers corresponding to each of the analyzer’s axes (U28,U29,U30,U24,U25,U27)
to act on the motor. The driver comprises the L6228 integrated circuit. The regulation of the current of each axis can
be configured by means of a DAC that sets the current set point independently (U26).

The action on the thermostatation systems of the rotor is carried out through H-shaped bridges based on MOS te-
chnology (U45) and controlled directly from the microprocessor. The action on the needle thermostatation system is
through the Q4 transistor.

Connector Function Pins

J1 Not available

J2 Connection to communications board 1 - V DC


(CIIM00036) 2 - GND
3 - Tx0
4 - GND
5 - Rx0
6 - GND
7 - GND
8 - Tx1
9 - GND
10 - Rx1

36
Connector Function Pins

J4 Connection to XYZ interconnection 1 - V DC


board (home and encoder signals) 2 - GND
3 - Needle encoder
4 - Home motor Y
5 - Home motor X
6 - GND
J5 Connection to XYZ interconnection 1 - coil 2 motor X
board (motor signals) 2 - coil 2 motor X
3 - coil 1 motor Y
4 - coil 1 motor X
5 - coil 1 motor Y
6 - coil 1 motor X
7 - coil 2 motor Y
8 - coil 2 motor Z
9 - coil 2 motor Y
10 - coil 2 motor Z
11 - coil 1 motor Z
12 - coil 1 motor Z

J6 Connection to interconnection 1 - 12 V
board 2 - GND
Rotor (home motor signals and 3 - DVALID
photometry board control signals) 4 - DCLK
5 - DOUT
6 - DXMIT
7 - RANGE2
8 - RANGE1
9 - RANGE0
10 - TEST
11 - CONV
12 - GND
13 - CLKAD
14 - GND
15 - GND
16 - V DC
17 - V DC
18 - Rotor cover
19 - GND
20 - Rotor thermistor
21 - Home motor filter drum
22 - GND
23 - Home motor rotor
24 - Front red LED
25 - Front green LED

J7 Connection to rotor interconnection 1 - coil 2 motor filters


board (motor and Peltier signals) 2 - coil 2 motor filters
3 - coil 1 motor filters
4 - coil 1 rotor motor
5 - coil 1 motor filters
6 - coil 1 rotor motor
7 - Peltier
8 - coil 2 rotor motor
9 - Peltier
10 - coil 2 rotor motor
11 - V(24 V)
12 - Peltier fans

37
Service manual

Connector Function Pins

J8 Connection to interconnection 1 - V(24 V)


board fluids (electrically operated 2 - Waste pump
valve and pump signals) 3 - V(24 V)
4 - Electrically operated valve
5 - coil 1 ceramic pump
6 - coil 1 ceramic pump
7 - coil 2 ceramic pump
8 - coil 2 ceramic pump

J9 Connection to interconnection 1 - Waste bottle sensor input


board fluids (ceramic pump home 2 - System liquid sensor input
and level sensor signals) 3 - Bottle detection signal
4 - Rack level detection signal
5 - Ceramic pump home
6 - V DC
7 - GND
8 - Instrument cover detection

J10 Connection to needle board 1 - V (12 V)


2 - GND
3 - Home motor Z
4 - Needle thermistor
5 - Rack level detection signal
6 - V (24 V)
7 - Needle thermostat elements
8 - NC

J11 Connection to supply board 1 - V (12 V)


2 - GND
3 - V (24 V)
4 - V DC
5 - Fan control
6 - Lamp control

Analogical circuitry:
The waste and system liquid sensors function through U6, U5 and U4, which generate and detect the signal responsible
for detecting the waste and system liquid. These signals are sent and received through the fluid interconnection board
(connected to the CPU board by J9). The rack level detection is carried out in a similar way through U7, U8 and U2.
The signal injected to the base of the bottles goes to the fluid interconnection board through J9 and is collected after it
has been amplified by J10 (connection with the needle board). There is also a circuit for conditioning the signal of the
thermistor associated with the thermostatation of the rotor that is made up of the U1 and U2 circuits. The thermistor
is connected to the rotor interconnection board, which is connected to the CPU board.
TP1 - Waste pump control signal
TP2 - Electrovalve control signal
TP3 - Rotor thermistor signal
TP4 - RESET
TP5 - WATCHDOG
TP6 - LSO_BOT bottle detection signal
TP7 - Bottle signal
TP8 - Needle detection signal
TP9 - LSO needle detection signal
TP10 - Attenuated LSO needle detection signal
TP11 - IN1 Needle Peltier Driver
TP12 - Needle resistance driver
TP19 - ASL
TP20 - HWR_L
TP21 - LWR_L
TP22 - WE_L
TP24 - CS_FPGA_L

38
TP25 - DVALID (photometry)
TP26 - 12 Volts analogical
TP27 - IN2 Needle Peltier Driver
TP28 - EF Needle Peltier Driver
TP30 - DOUT (photometry)
TP33 - RANGE (photometry)
TP34 - CLKAD (photometry)
TP35 - Conditioned thermistor signal
TP38 - DXMIT (photometry)
TP39 - Analogical GND
TP40 - Power GND
TP41 - Power GND
TP42 - Power GND
TP43 - Digital GND
TP44 - Digital GND
TP45 - Digital GND

LIST OF LED DIODES

DL1 - Electrovalve driver


DL2 - Waste pump driver
DL3 - PELTIER heating
DL8 - PELTIER cooling
DL4 - Needle resistance driver

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Service manual

40
4.3. Power Supply Board (CIIM00015)

This is made up of 2 different switched regulators and 1 voltage line that enable distribution of the power supply in
accordance with the requirement of each subsystem.

Connector Function Pins

J1 24 V input 1 - 24V
3 - (GND)

J2 Output voltage of 6 V for lamp 1-6V


supply 3 - GND

J3 Output voltage of 24 V, 12V, 1 - 24V


5 V and fan and lamp control 2 - GND
input 3 - 12V
4 - 5V
5 - ENABLE LAMP
6 - ENABLE FAN

J4, J5 Fan output voltage of 24 V 1 - 24V


2 - GND

TP1 - Lamp voltage from 5.75 V <6V


TP2 - 12V analogicals
TP3 - 5V digital

List of LED diodes:

D4 - Indicates 5V activated
D2 - Indicates 12V lamp activated
D3 - Indicates 12V analogicals activated

4.4. Needle Board (CIIM00017)


This board conditions the thermistor signal associated with the thermostatation of the needle, the preamplification of
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Service manual

the level detection signal and the Z home. It receives, from the needle unit, the thermostatation elements, the ther-
mistor and the level signal detected by the needle itself.

The cables that join this board with the CIIM00026-01 board come from this needle

Connector Function Pins

J1 CPU board connection 1 - GND POWER


(CIIM0026) 2 - 12V analogical
3 - level sensor
4 - Home Z
5 - GND POWER
6 - Thermistor
7 - EARTH
8 - GND POWER
9,10 - Thermo elements.

TP1 - Needle signal


TP2 - Output preamplifier needle signal
TP3 - Output amplifier thermistor signal
TP4 - Thermistor
12V - 12V voltage
5V - Voltage 5V
AGND - GND

4.5. Photometry Board (CIIM00027)


This board also has the heart of the absorbance measuring system for the samples to be analyzed. It is made up of
a photosensor and an associated analogical-digital conversion circuitry (DDC112).
JP1 - soldering bridge - Solder only if the local oscillator and the U4 and U5 scales, respectively, are not present.
JP2 - soldering bridge - as per JP1
JP3 - soldering bridge - joins together the analogical and digital frames

42
Connector Function Pins

J3 Photometric board connection CIIM00029) 1 - 12 V


2 - GND
3 - DVALID
4 - DCLK
5 - DOUT
6 - DXMIT
7 - RANGE2
8 - RANGE1
9 - RANGE0
10 - TEST
11 - CONV
12 - GND
13 - CLKAD
14 - GND
15 - GND
16 - V DC

4.6. XYZ Interconnection Board (CIIM00018)


This board interconnects the CP1 board with the X carriage. It distributes the X and Y motor signals and transmits the
home signals of the X and Y movements. It also sends the encoder signal to the CPU board.

Connector Function Pins

J1 Connection motor X

J2 Connection motor Y

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Service manual

Connector Function Pins

J3 Connection motor Z

J4 CPU board connection 1 - coil 2 motor Y


(CIIM00026) 2 - V DC
3 - coil 2 motor Y
4 - GND
5 - coil 1 motor Y
6 - encoder
7 - coil 1 motor Y
8 - home motor X
9 - coil 2 motor Y
10 - home motor X
11 - coil 2 motor Z
12 - GND

J5 CPU board connection 1 - coil 2 motor X


(CIIM00026) 2 - coil 2 motor X
3 - coil 1 motor X
4 - coil 2 motor Z
5 - coil 2 motor Z
6 - coil 1 motor Z

4.7. Communications Board (CIIM00019)

This enables communication with the exterior of the analyzer through a USB channel or a RS232 channel. It also
includes an auxiliary RS232 channel for monitoring the functions of the analyzer during its execution.
44
CN1 - USB Connector
P1 - Main RS232 connector
P2 - Auxiliary RS232 connector

Connector Function Pins

J1 CPU board connection (CIIM00026) 1 - V DC


2 - GND
3 - Tx0
4 - GND
5 - Rx0
6 - GND
7 - GND
8 - Tx1
9 - GND
10 - Rx1

4.8. Rotor interconnection board (CIIM00029)


This interconnects the rotor with the CPU board.

Connector Function Pins


J1 Rotor motor connection

J2 Power connection with board CIIM00026 1 - Coil 2 rotor motor


2 - Coil 2 rotor motor
3 - Coil 1 rotor motor
4 - Coil 1 motor filters
5 - Coil 1 rotor motor
6 - Coil 1 motor filters
7 - Peltier
8 - Coil 2 motor filters
9 - Peltier
10 - Coil 2 motor filters
11 - V24 (fans)
12 - GND (fans)

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Service manual

Connector Function Pins


J3 Connection with photometry board CIlM00027 1 - 12 V
2 - GND
3 - DVALID
4 - DCLK
5 - DOUT
6 - DXMIT
7 - RANGE2
8 - RANGE1
9 - RANGE0
10 - TEST
11 - CONV
12 - GND
13 - CLKAD
14 - GND
15 -GND
16 - V DC
J4 Connection motor filters 1 - Coil 1
2 - Coil 1
1 - Coil 2
2 - Coil 2
J5 Peltier connection 1 - Peltier black
2 - Peltier, red
J6 Fan connection 1 - Fan, black
2 - Fan, red
J7 Connection signal with board CIM00026 1 - 12 V
2 - GND
3 - DVALID
4 - DCLK
5 - DOUT
6 - DXMIT
7 - RANGE2
8 - RANGE1
9 - RANGE0
10 - TEST
11 - CONV
12 - GND
13 - CLKAD
14 - GND
15 - GND
16 - V DC
17 - V DC
18 - Rotor cover sensor
19 - GND
20 - Thermistor signal
21 - Home filter drum
22 - GND thermistor
23 - Home rotor
24 - Front LED (red)
25 - Front LED (green)
26 - Ambient sensor
J8 Rotor cover sensor connection 1 - Cable 1
2 - Cable 2

J9 Thermistor connection 1 - Cable 1


2 - Cable 2

1 - Front LED, red


J10 Front LED connection
2 - Front LED, black
3 - Front LED, green

1 - Photo sensor, yellow


J11 Connection Home motor filters
2 - Photo sensor, black
3 - Photo sensor, red

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Connector Function Pins

1 - Photo sensor, yellow


J12 Connection Home rotor
2 - Photo sensor, black
3 - Photo sensor, red

J13 Connection fans 1 - Fan, black


2 - Fan, red

List of LED diodes

DL1 - Peltier
DL2 - Home rotor motor
DL3 - Home filter motor
DL4 - Rotor cover

4.9. Pump interconnection board (CIIM00028)


The pump interconnection board interconnects the CPU board with the dispensing pump, the waste pump, the elec-
trovalve, the bottle level sensor and the instrument cover.
List of LED diodes

DL1 - Electrovalve
DL2 - Waste pump
DL3 - Home pump
DL4 - Instrument cover

Connector Function Pins

J1 Waste sensor 1 - Waste sensor

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Service manual

Connector Function Pins

J2 Connection signal with board CIIM00026 1 - Waste sensor


2 - System liquid sensor
3 - LS/waste signal
4 - Needle liquid detection signal
5 - Home dispensation pump
6 - V DC
7 - GND
8 - Instrument cover

J3 System liquid sensor 1 - System liquid sensor

J4 LS/waste sensor signal 1 - System liquid signal

J5 Needle liquid detection signal 1 - Needle liquid detection signal

J6 Dispensation pump home 1 - Photo sensor, yellow


2 - Photo sensor, black
3 - Photo sensor, black

J7 Electrovalve 1 - White cable


2 - White cable

J8 Power connection with board CIIM00026 1 - 24 V electrovalve


2 - GND
3 - Waste pump
4 - Waste pump
5 - Dispensation pump coil 1
6 - Dispensation pump coil 1
7 - Dispensation pump coil 2
8 - Dispensation pump coil 2

J9 Waste pump 1 - Waste pump, red


2 - Waste pump, black

J10 Waste pump 1 - Coil 1


2 - Coil 1
4 - Coil 2
5 - Coil 2

J11 Instrument cover 1 - Photo sensor, yellow


2 - Photo sensor, black
3 - Photo sensor, red

48
4.10. Refrigerator cooler board (CIIM00075)

Conector Función Pins

1- 5V5
CN1 POWER SUPPLY
2- GND

1 - 5V
CN2 PUMPS- J11
2 - GND

1 - 5V
2 - GND
CN3 PUMPS- J13
3 - GND
4 - Earth

1 - Temp
CN4 FRIDGE THERMISTOR
2 - GND

1 - 5V5
2 - Peltier 1
CN5 PELTIERS CELLS
3 - 5V5
4 - Peltier 2

1 - 5V5
2 - Fan1
3 - 5V5
4 - Fan 2
CN6 PELTIER FANS
5 - 5V5
6 - Fan 3
7 - 5V5
8 - Fan 4

1 - Green
CN7 STATUS LED 2 - GND
3 - RED

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Service manual

4.11. Auxiliar channel information


FLASH functions transferred to RAM
Interrupt Vectors transferred to RAM
The rear left part of the instrument is where the communi-
Interrupts enabled
cations cables are connected. There are two connections,
the COM1 and the COM2. Checking firmware integrity
The COM1 is the main connection from the analyser to Checking program checksum:
Checksum correct! Program Checksum=0x5039 Size=427100
the computer. This connection should be always present
to analyser run propertly. Checking A15 configuration checksum:
there are two connection types: Checksum correct! Configuration Checksum=0x179C Size=856

Checking A15 configuration backup checksum:


Checksum correct! Configuration backup Checksum=0x179C
Size=856

Loading A15 Configuration from FLASH


Configuration in FLASH is correct

Adjustments loaded:

Temperature correction for Rotor=0.50


Temperature correction for Probe=0.00
System Liquid Detection=30
Waste Detection=29
Sensitivity of level detection=110
Origin X=60
Origin Y=280
Origin Z=430
Tray Reference X=675
Tray Reference Y=10
Washing station X=360
A - Cable type USB Washing station Y=5
B - Cable type RS-232 Washing station Z=450
Washing station Ext X=360
Only connect one cable type. Washing station Ext Y=95
Washing station Ext Z=540
Reactions Rotor X=110
The labeled connector COM2 is the auxiliar connector. Reactions Rotor Y=1044
This connector is used to communicate with a second Reactions Rotor Z=600
serial port in the computer. The function of this cable is Rotor Distance between the dispensation point and the optic sys-
tem=610
to monitor the internal states of the analyser. Rotor Position correction regard to the dispensation point=98
To show all this information, the user should execute the Rotor Position correction regard to the optic system=-4
program: windows HyperTerminal and configure with the Filters Wheel correction=0
following parameters: Filters and their Integration Times:
Programa: Inicio\Todos los programas\accesorios\comu- Filter 1=000 Integration Time= 20ms ( 40) Reference Time=
nicaciones\hyperterminal 0ms ( 0)
Filter 2=340 Integration Time=205ms (400) Reference Time=
Baud Rate: 38400 0ms ( 0)
Filter 3=405 Integration Time= 51ms (100) Reference Time=
Número de bits: 8 0ms ( 0)
Stop bits: 1 Filter 4=505 Integration Time= 51ms (100) Reference Time=
Paridad: none 0ms ( 0)
Onces is configured and connected the cable, switch on Filter 5=535 Integration Time= 51ms (100) Reference Time=
0ms ( 0)
the analyser. In this moment will appear in the HyperTer- Filter 6=560 Integration Time= 51ms (100) Reference Time=
minal screen information about the analysers mode and 0ms ( 0)
the different executes states. In the initializate mode, Filter 7=600 Integration Time= 51ms (100) Reference Time=
the analyser do an internal checking for each element, if 0ms ( 0)
Filter 8=635 Integration Time= 51ms (100) Reference Time=
someone has any error then in the screen will show the 0ms ( 0)
element that fails. The following lines shows an exemple Filter 9=670 Integration Time= 51ms (100) Reference Time=
of the instructions during an initialization, (this information 0ms ( 0)
could change with the improvements of the firmware) : Filter 10=000 Integration Time= 20ms ( 40) Reference Time=
0ms ( 0)

BIOSYSTEMS A15 TI/LB Hystoric:


F[01]: 00000000 00000000 00000000 00000000 00000000 00000000
00000000 00000000 00000000 00000000
Firmware initialization F[02]: 00000000 00000000 00000000 00000000 00000000 00000000
Firmware Version: A15 User V3.12 00000000 00000000 00000000 00000000
Serial Number: 831050311 F[03]: 00000000 00000000 00000000 00000000 00000000 00000000

50
00000000 00000000 00000000 00000000 Hello World“
F[04]: 00000000 00000000 00000000 00000000 00000000 00000000
00000000 00000000 00000000 00000000
F[05]: 00000000 00000000 00000000 00000000 00000000 00000000 A15 MAGIC KEYS“
00000000 00000000 00000000 00000000
F[06]: 00000000 00000000 00000000 00000000 00000000 00000000 H: Help“
00000000 00000000 00000000 00000000 R: Rotor Temperature“
F[07]: 00000000 00000000 00000000 00000000 00000000 00000000 P: Probe Temperature
00000000 00000000 00000000 00000000 S: Level Scales
F[08]: 00000000 00000000 00000000 00000000 00000000 00000000 A: Last A15 Stress Results
00000000 00000000 00000000 00000000 L: Actual Sensitivity of Level Detection
F[09]: 00000000 00000000 00000000 00000000 00000000 00000000 N: Enable Level Detection Debug
00000000 00000000 00000000 00000000 K: Power Supply On
F[10]: 00000000 00000000 00000000 00000000 00000000 00000000 Buzzer Control
00000000 00000000 00000000 00000000 B: Buzzer On
b: Buzzer Off
F[01]: 000 000 000 000 000 000 000 000 000 000 Encoder
F[02]: 000 000 000 000 000 000 000 000 000 000 E: Generate Encoder Error
F[03]: 000 000 000 000 000 000 000 000 000 000 I: Enable Encoder IRQ
F[04]: 000 000 000 000 000 000 000 000 000 000 Rotor Reading
F[05]: 000 000 000 000 000 000 000 000 000 000 1: Choose Filter +
F[06]: 000 000 000 000 000 000 000 000 000 000 2: Choose Filter -
F[07]: 000 000 000 000 000 000 000 000 000 000 9: Start Rotor Readings
F[08]: 000 000 000 000 000 000 000 000 000 000 Notes: Use only in Service Mode
F[09]: 000 000 000 000 000 000 000 000 000 000 after a Base Line Test.“
F[10]: 000 000 000 000 000 000 000 000 000 000 Rotor Read
1: Choose Filter +
Zmax Reference=1130 2: Choose Filter -
- Pediatric Offset=0 User Mode Test
- 13mm Offset=0 G: Test
- 15mm Offset=0 Notes: Use only after a Worklist in
- Reagent Offset=0 Stand By.“
- Central Reagent Offset=0 This tests dumps all the preparations“
parameters received and the photometric“
A15 Mechanical History readings. Finally performs a general test“
of the analizer.“
- X axis: 0 Steps After this test press New Rotor
- Y axis: 0 Steps for continue working.“
- Z axis: 0 Steps DDC112/Photometry
- Rotor: 0 Steps D: Choose Mode
- Filter Wheel: 0 Steps - DDC112 internal test mode
- Ceramic Pump: 0 Steps - DDC112 Photometry Mode
- Washing Station Pump: 0 Cycles - Stop
- Washing Station Valve: 0 Cycles +: Integration Time +0.5ms
- Ceramic Pump Valve: 0 Cycles -: Integration Time -0.5ms
- Lamp: 0 Minutes Notes: Only works in Service Mode
This tests performs continuous“
A15 Statistics readings with the DDC112.“
Remember stop the test for “
- Biochemistry Tests: 0 continue working.“
- Turbidimetry Tests: 0
- Biochemistry Bireagent Tests: 0 Caution: Dont’t abuse of this functions while the
- Turbidimetry Bireagent Tests: 0 analizer is running.“
- Predilutions: 0
- Initial/Final Washings: 0 <>
- Washing Solution Washings: 0 Rx
- System Liquid Washings: 0 Stand by mode!
- New Rotor: 0 LC
- Bireagent Contaminations Solved: 0 TxS
Rx
Inicio modo servicio!

Setting racks layout Hardware Initialization

Tray Ref. X=675 => Distance from tray reference to tray corner X=2190 Programming FPGA XC2S50PQ208
Tray Ref. Y=10 => Distance from tray reference to tray corner Y=30 - Clearing FPGA program memory: OK!
- Programing FPGA: OK
Absolute position of tray corner X=2865 FPGA XCS50PQ208 is programmed
Absolute position of tray corner Y=-20
Generating Zmax Map:Ok
“ Initialization of level detection system
CPU settings: MDCR=c4;ABWCR=0;ASTCR=ff“ - Generating Sensitivity Map:Ok
Level Detection Mode:Normal
BioSystems A15“

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Service manual

Pediatrico:
Rack 1 2 3 4 Probe AA
173 141 129 126 123 125 129 151 - X:X=Xcal+-1“
161 129 118 115 113 115 125 141 - Y:Y=Ycal+0“
158 128 114 111 108 111 121 138 AAEnd
156 127 113 108 107 110 118 139 Peltier Cells and Drivers Test
156 127 112 108 107 110 117 145 - Probe Peltier Driver Test: Ok! (Not implemented)
155 126 112 108 106 110 121 146 - Rotor Peltiers Driver Test: Ok!
161 128 113 110 106 112 121 151
160 132 112 111 106 113 121 151 Hardware Initializated
167 133 115 112 108 114 124 156
171 136 117 116 113 119 129 163 There are a few keys that work with the Hyperterminal,
177 145 123 122 116 124 136 172
202 160 139 135 133 138 155 190
to press some keys the analyser give information about
some element, the following keys has the function:
Tubo 13/15mm:
Rack 1 2 3 4 H: Help, help, shows the help text
162 141 126 123 119 123 132 147
149 132 115 115 111 115 121 137
R: Rotor Temperature, shows the rotor temperature
145 126 110 111 107 112 115 136 P: Probe Temperature, shows the needle temperatare
148 127 111 108 106 110 117 136 S: Level Scales, shows the scales mesures in %
148 127 112 111 105 110 118 144 A: Last A25 Stress Results
149 128 111 111 107 113 119 145
154 126 113 110 108 111 119 144
L: Actual Sensibility of Level Detection
155 128 115 111 110 113 124 145 N: Activate additional information of level detection (only
161 130 114 112 110 115 125 148 internal use)
161 133 117 112 112 116 125 154 K: Deactivate the power supply
169 140 123 121 118 122 133 161
190 155 134 133 128 134 146 176
B: Activate the buzzer
b: Deactivate the buzzer
Reactivos: E: Generate an encoder error (only internal use)
Rack 1 2 3 4 I: Activate the encoder interrupt (only internal use)
163 151 152 183
156 141 143 174
152 138 140 173 1: Increase the filter wheel position
150 134 137 172 2: Decrease the filter wheel position
154 135 138 176 9: Mesure the whole rotor, step by step
156 139 143 181
160 138 145 187
166 145 149 194 G: Once finish a work list, push the G and send to the
173 150 156 204 hyperteminal more detailed information of the work list
194 172 173 228 managemnet

Initializating Motors D: Show the mesure depending on the number of key


- Axis Z in HOME pressed
- Axis Y in HOME 1st press: activate the internal test DDC112,
- Axis X in HOME
- ROTOR in HOME
always show the same count number
- FILTERS WHEEL in HOME 2nd press: activate the normal mesure DDC112,
- CERAMIC PUMP in HOME show the count number mesured
Motors Initializated 3th press: stop the DDC112 mesure
Optics Initialization
+: Increase the integration time in 0.5ms
- Filter correction=0 -: Decrease the intergration tie in 0.5ms
- Rotor correction=98 Rotor Lect. correction=-4
- Used wells:0

- Check DDC112..OK (FPGA 8Mhz Clock: OFF)


- DDC112 test: OK! (Result => 0046387)
Optics Initializated

Generating Pattern: 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0
Generating Gate: 0 0 0 0 1 1 1 1 0 0 0 0 0 0 0 1 1 0 0 0
OK
Z Axis Initialization
- Axis Z in HOME
Z Axis initializated

Penc:111111111000000000| OK

Z Axis Initialization
- Axis Z in HOME
Z Axis initializated

52
4.12. Interconnection between boards
The following diagrams show the connections between the boards and the different elements that make up the analyzer.

53
Service manual

54
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Service manual

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Service manual

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Service manual

4.13. Schematic liquid circuit

60
5. Service program
The service program is used for the adjustment, checking and maintenance of the different components of the
analyzer. It is not supplied with the instrument, it is supplied to authorised technical services only. The personal
of the Technical Service must install it on the user’s computer in order to carry out the service requirements.
Once the tasks have finalised, the program must be uninstalled. To install the program, follow the instructions
on the installation CD ROM called Service. The original password for using this program is A15. The password
can be changed from the service program itself. If the service personnel forget the password, the original pas-
sword can be reinstalled by deleting the hidden file code.A15 from the application directory and relaunching
the program. Once the password has been introduced, the analyzer serial number is given and the name of
the operator is requested (by default Operator1). Press the Accept button and the main program appears. The
different functions of the service program are classified in the following categories:
• Adjustments: These make it possible to make different parameter adjustments required for the correct
functioning of the analyzer.
• Tests: Tests for checking the functionality of the a­na­ly­zer.
• Utilities: Different technical utilities, such as, for example, washing or priming the dispensing sys­tem
or changing an optical filter.
• Registers:This enables the management of past adjustments, tests, incidences, repairs and maintenance
of the instrument.
• Monitor:These enable the low level communication with the analyzer to load new versions of the program
in the flash memory of the analyzer (firmware) or to consult the internal parameters of the instrument.
An emergency stop button (STOP on a red background) will be accessible at all times, and when pressed, it
switches off the analyzer and closes the application quickly.

5.1. Initialising the analyser


To initialise the analyser in service mode, first launch the A15 Service application. The program first of all re-
quests a user or technician ID to be used in the program. Depending on the type of user identified, access to
the different parts of the program will be allowed or denied. The following screen appears:
For full access, enter the following codes:

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Service manual

Modelo A15 Y15


Name (login) SAT SAT
password A15 A15
Once the user has been identified correctly, the service program starts to initialise the analyser.
This screen appears when the analyser has finished the previous operations done to enter the SERVICE mode. If
the complete hardware of the analyzer is in correct conditions, the result “Hardware initiated correctly» displays.
If any hardware element presents an operational problem, it will appear “Hardware not initiated completely” in
the screen, and the element that is not working correctly will be shown.
In order to close the screen and continue working, you should press the Accept button.

62
In order to get a printed copy of this initialization report, you should press the Print button.
NOTE: If an error has been reported and the technician continues working with the service program, he must
consider that there is a hardware element that is not working properly.

5.2. Adjustments

These make it possible to make different parameter adjustments required for the correct functioning of the analy-
zer. All the values to be adjusted have certain limited ranges, indicated by the service program. These values are
also given in an appendix at the back of this manual. If, after varying any of the parameters within its permitted
range, the analyzer is not tuned up, it indicates that the corresponding system is broken and in need of repair.

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Service manual

5.2.1. Adjustment of the needle thermostatation system

This screen adjusts the needle thermostatation in such a way that the dispensing temperature of the reactions
is as close as possible to 37ºC. To make this adjustment, the analyzer must be initialised. The liquid to be dis-
pensed is taken from the system liquid container or from the bottle of reagent selected by the technician. The
technician must measure the temperature of the dispensed liquid with a thermometer calibrated at 37ºC. The
program shows the control set point temperature, which is the parameter that must be adjusted for the dispen-
sing temperature to be correct. This parameter must be different from 37ºC. When the technician so indicates,
the analyzer dispenses thermostated distilled water on a certain position in the racks tray shown on the screen.
The technician must measure the temperature of the water with the calibrated thermometer and introduce the
temperature on the screen. The analyzer automatically modifies the set point temperature in accord with the
temperature measured with the thermometer for the dispensing temperature to be 37ºC. The technician can
modify this set point temperature proposed by the program. On pressing Adjust, the analyzer thermostates
the needle with the new set point and, when the technician so requests, performs new dispensing operations.
Each time the set point temperature is modified, wait 1 minute before performing new dispensing operations
for the needle temperature to become stabilised. The technician must repeat this process until the dispensing
temperature is as near as possible to 37ºC. Pressing the Store button, the analyzer stores the current value
of the adjusted set point temperature. Pressing the Cancel button keeps the last stored value and the current
value is not stored. Pressing the Restore button restores the initial screen input value.

5.2.2. Adjustment of the rotor thermostation system

This screen makes it possible to adjust the thermostation system of the rotor in such a way that the reactions
temperature is 37ºC. To make this adjustment, place a well rotor in position and ensure that the analyzer has
been initialised. The rotor can be automatically filled with distilled water by pressing the corresponding button.
Once filled, the technician must wait a few minutes for the rotor to be thermostated. The temperature in the
rotor wells must be measured with a temperature calibrated at 37ºC through the dispensing hole of the rotor
cover. A button makes it possible to turn the rotor in increases of 15 wells to change the well on which the
measurement is being taken. The program shows the control set point temperature, which is the parameter that
must be adjusted for the temperature of the rotor to be correct. This parameter must be other than 37ºC. The
technician must measure the temperature of the water with the calibrated thermometer in the wells and enter
the temperature on the screen. The analyzer automatically modifies the set point temperature in accord with
the temperature measured with the thermometer for the rotor reactions temperature to be 37ºC. The technician
can modify this set point temperature proposed by the program. On pressing Adjust, the analyzer thermostates
the rotor with the new set point. Each time the set point temperature is modified, wait 5 minutes before perfor-
ming new dispensing operations for the rotor temperature to become stabilised. The technician must repeat
this process until the rotor temperature is as near as possible to 37ºC. Pressing the Store button, the analyzer

64
stores the current value of the adjusted set point temperature. Pressing the Cancel button keeps the last stored
value and the current value is not stored. Pressing the Restore button restores the initial screen input value.

5.2.3. Adjustment of the positioning of the operating arm

This screen makes it possible to adjust the horizontal positioning (X, Y) of the arm. The arm housing must be
removed to see the position of the needle. Before making the adjustments, visually check the verticality of the
needle. If necessary, carefully straighten it up ensuring you do not damage it. On the screen, select the point
at which you wish to adjust the horizontal positioning. On pressing the Adjust button the arm initialises and
positions itself over said point. The technician has buttons to move the arm step by step over the horizontal
plain (X, Y) and vertically (Z). The arm can also be moved introducing a certain number of absolute movement
steps. These absolute movements of the arm must be made with the needle at its highest position so as not to
damage it (coordinate 0). The technician must lower the needle to the adjustment point and adjust its horizontal
position. When the position is satisfactory, save the current coordinates (X, Y) by pressing the Store button.
Pressing the Cancel button keeps the last adjustment values stored. Pressing the Restore button restores the
initial screen input values. At all times, the screen shows the current coordinates of the arm for the selected
point, the last coordinates stored and the initial screen input coordinates, as additional information for the te-
chnician. The technician may repeat the procedure to adjust the positioning of the arm at the different possible
adjustment points. These points are as follows:

1. Origin. Vertex of the self-centering plate of the needle.


2. Rack tray Adjust point located in the right part at rear of the tray
3. Washing station. Centre of front part of washing station.
4. Reactions rotor. Dispensing point on the rotor reactions cover.
5. Adjustment of X, Y, Z positions tray for reagents and pediatric racks.
If you select the point of origin, automatic adjustment is possible in this position by pressing an AutoAdjustment
button (the process can take around 3 minutes).

5.2.3.1. Adjustment of X, Y and Z position for reagent and pediatric racks

Note: the pediatric rack is a 15 diameter rack with pediatric adapters and wells
This process is used to adjust each rack individually in the three coordinates, X, Y and Z as much for pediatric

65
Service manual

as for reagent racks. For that, each rack of the tray will be adjusted to positions 1 and 12 for pediatric racks
and 1 and 10 for the reagent ones.
There are two tools to carry out the adjustment process: one to adjust the reagent rack and the other for the
pediatric rack.
In order to carry out this XYZ rack adjustment, you may use the screen or keyboard buttons. Movements using
keyboard:
• X axis movements: right and left cursor button
• Y axis movements: up and down cursor button
• Z axis movements: page up and page down button

The instruments with reagent refrigerator has itself options

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Adjustment process
1. Select the type of adjustment which you wish to carry out: adjustment of the tray (XYZ) of the pediatric
diameter rack or of the reagent rack.
2. Press the button Adjust.
3. Deactivate the option Adjust with the tool
4. Select the number of rack to start the adjustment process. By default, it starts with number 1.
5. Place the rack in the selected position, place the well or bottle in well number 1 of the rack and press Start.
6. Probe will automatically descend to a distance over the well/bottle, in order to avoid colliding with it. Then,
probe has to be put into the well/bottle just a little. In order to do so:
- If probe is not centered in XY and out of the well or bottle opening: move the probe just by XY movements
(screen or keyboard) before carrying out Z movements to get the probe down.
- Then, get the probe slightly down with Z movements (screen or keyboard) just to make the adjustment
of the center easier.

From this position of approach, you may start the adjustment of values:
7. Adjust the well/bottle center: to do so, move the probe by X and Y movements (screen or keyboard)
8. Adjust the bottle or well bottom: to do so, move the probe by Z movements (screen or keyboard) until it
reaches the bottom. To check it: move the bottle/well up and down.
9. To finish the XYZ adjustment, press Accept.
10. The new adjusted XYZ values will appear in the upper table. (Nevertheless, they are not saved in the
instrument yet).
11. The arm will automatically move to position 10 or 12, depending on the type of rack selected. Repeat steps
6 to 9.
12. Once the adjustments in position 10 or 12 are carried out, the arm is parked so the rack can be moved.
13. Place the rack in the following position of the tray, press Start. Repeat steps 6 to 9 to carry out the ad-
justments in the every position of the rack tray.
14. Once the adjustments are finished, adjustments have to be kept in the instrument, so press Save.

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5.2.3.2. Instruments with reagent cooler

The adjust is performed in the same way of an instrument without reagent cooler. Keep in mind that the adjust
for sample racks (pediatics or tubes ) only will perform in the 3 and 4 positions:

The reagent cooler will only fit in positions 1 and 2 and adjusts similarly as a reagent rack. To do this select
XYZ Tray-fridge.

5.2.3.3. Adjustment of Z-axis of tubes

When the adjustment of the tray of pediatric racks is selected, it appears another adjustment: the Z relation
between pediatric and tube.

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In order to carry out this adjustment, follow the following steps:
1. Place a diameter 15 rack in position 2 of the tray, with a tube in rack position 1.
2. Insert a value in the box of Z pediatric-tube relation. This value shows the separation steps between a
pediatric well and a primary tube.
3. Press Start.
4. Check that the probe has not collided to the bottom of the tube.
5. Move the probe by Z movements (screen or keyboard) until it reaches the well bottom.
6. Once the adjustments are finished, adjustments have to be kept in the instrument, so press Save.

5.2.3.4. Stool tubes Z-axis adjustment

When you want to use the stool tubes, it is necessary to carry out the following adjustment, once the tip model
has been changed:
1. Place in the position 2 of tray a 15 diameter rack with a stool tube in position 1.
2. Enter a value in the Z pediatric-stool tube relation box. This value indicates the separation steps between
a pediatric well and the tube. Enter a value so that the tip touches the inner liquid of the stool tube.
This ratio of Z-Pediatric to Z-stool tube is negative. Unlike the Z-Pediatric ratio with 15mm/13mm tube
which is positive
3. Press Save.

NOTE: If the instrument comes from a previous Firmware and has been updated by the technical service to
the version that incorporates the stool tubes (v6.16 or higher), the ratio Z pediatric-stool tube will be 0. This
means that in the positioning to make the adjustment the tip will lower to the position of Z for pediatric well. It
is recommended not to use a stool tube in that first case since the tip can get too low and collide. Using a tube
or nothing in that position, perform a pre-adjustment leaving the offset at -500.
Proceed then to make the adjustment in the indicated way.

5.2.4. Adjustment of the positioning of the rotor

This screen enables the adjustment of the positioning of the rotor with regard to the dispensing point and the
optical system. One or the other is selected by means of two different tabs.

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5.2.4.1. Centering of the rotor with regard to the dispensing point

Put the tool AC15920 in the first well of the rotor. Ensure that the component is positioned until the bottom of
the well. The point of dispensation of the rotor is indicated with the hole of the tool.

The analyzer initialises the rotor and positions the first rotor well at the currently programd dispensing position.
The technician has buttons to move the rotor step by step to adjust, if necessary, this position and buttons for
finer adjustment of the X coordinate over the dispensing point. At all times, the screen shows the current dis-
pensing coordinate on the first well and of the X axis position, the last coordinate stored and the initial screen
input coordinate, as additional information for the technician. When this is satisfactory, the current coordinate
of the dispensing point of the first well can be stored by pressing the Store button. Pressing the Cancel button
keeps the last stored value and the current value is not stored. Pressing the Restore button restores the initial
screen input value.

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5.2.4.2. Centering of the rotor with regard to the optical system

This adjustment is necessary only if the Rotor Centering Adjustment has been carried out with regard to the
dispensing point (4.1.4.1.). This adjustment must be made with the rotor cover in position. The analyzer initia-
lises the rotor and fills the first 3 wells of the rotor with distilled water. Next, step-by-step optical readings are
made through these wells at the wavelength selected by the technician. Once the readings have ended, the
program shows a graph of the light intensity measured on the rotor steps. On this graph, the program indica-
tes at which points the optical readings are made on each of the 3 wells when the analysis is made, with the
coordinate of the reading point of the first well currently programd in the analyzer. If necessary, the technician
can move the reading points over the graph jointly using two buttons. The optimum reading point is that which
globally maximises the light intensity for the three wells. At all times, the screen shows the current coordinate
of the reading in the first well and the last coordinate stored, as additional information for the technician. When
the position is satisfactory, the current coordinate of the reading point of the first well can be stored by pressing
the Store button. Pressing the Cancel button keeps the last stored value and the current value is not stored.

5.2.5. Adjustment of the positioning of the filter wheel

This adjustment must be made with the rotor cover in position. The analyzer initialises the rotor and the filter
wheel and fills the first rotor well with distilled water. Next, it takes optical readings through this well, turning the
filter wheel step by step, with a certain integration time as indicated by the technician (the concept of integration
time is explained in the section on photometric adjustments). Once the readings have ended, the program shows
a graph of the light intensity measured on the steps of the filter wheel. On this graph, the program indicates at
which points each of the filters is positioned when optical readings are taken when the analysis is carried out,
with the coordinate of the positioning of the filter 0 currently programd in the analyzer. If necessary, the technician
can move the reading points over the graph jointly using two buttons. The optimum reading point is that which
globally maximises the light intensity for all the filters. At all times, the screen shows the current coordinate
of the filter 0 and the last coordinate stored, as additional information for the technician. When the position is
satisfactory, the current coordinate of the positioning of the filter 0 can be stored by pressing the Store button.
Pressing the Cancel button keeps the last stored value and the current value is not stored.

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5.2.6. Adjustment of the level control scales

This screen makes it possible to set the level control scales with the empty waste and distilled water containers
(0% capacity) and when they are full (100% capacity). The maximum capacity of the containers is approximately
3L. The technician must choose whether he wishes to set the distilled water or waste container scales, with the
corresponding container full or empty. According to the requested adjustment, the corresponding container, full
or empty, must be placed in position and the Adjust button pressed. Based on the settings made, the analyzer
automatically adjusts the scales. On pressing the Store button, the analyzer saves the new values of the adjus-
ted parameters. Pressing the Cancel button keeps the last stored values and the current values are not stored.

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5.2.7. Adjustment of the level detection sensitivity

This screen allows fitting the sensitivity of the capa­city level detection system of the probe. In order to make
the adjustment, first of all you have to select the typs of racks: metal filled racks (grey color) or plastic racks
(black color).
Then select the type: pediatric, diameter 13 / 15mm, reagent or stool collector
In the rack rack position 2 (starting from the left) the selected rack must be placed with the following configu-
ration depending on the type of rack:
• Paediatric Rack: place 4 paediatric glasses in positions 6, 7, 18 and 19 with 150 uL of liquid system.
• Rack of 13/15mm sample: place 4 tubes in positions 6, 7, 18 and 19 with 1000 uL of liquid system.
• Rack of reagents: place 2 bottles of 20mL in positions 5 and 6 with 2mL of liquid system.

It is possible to see a graphic with the position of the tubes and racks in the screen photo. When pressing the
Adjust button, the arm takes some sensitivity readings automatically until detecting the water in each one of
the tubes. Once this operation is finished, the arm is parked in its original position and it shows the sensitivity
results of each one of the tubes. Move rack to position 5 and repeat the adjustment. Once these second rea-
dings are finished, the program calculates the average of all sensitivities; the result is the average sensitivity.
The technician should notice that the sensitivity values of each tube have to be similar; otherwise, he should
repeat the whole measurement.
Repeat this adjustment per each rack type.
The sensitivity value can also be introduced manually for each rack in the corresponding box.
Pressing the button Save, the analyser saves the new adjusted sensitivity value. Pressing the button Close,
the old value stays. Pressing the button Restore, the initial value of entry to the screen is restored. A manual
sensitivity value can be inserted in the corresponding box.

5.2.8. Instruments with reagents cooler

In instruments with reagent cooler the adjust of pediatrics cups will made in the position 3, as shown in the
figure. To adjust the level sensibility of reagent racks outside the cooler proceed in the same way.

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To adjust the level sensitivity of the reagent racks of cooler place 2 containers of 20 mL with 2 mL of system
liquid in the positions 5 and 6.

5.2.9. Sensitivity adjustment in the analyzer to determine stool analytes

With the new tip to determine stool analytes readjust the sensitivity of the level detection.
• Stool collector rack: manually enter the sensitivity value to 255

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5.2.10. Select the model of the instrumento

To select the model of the instrument go to the main menu option Adjusts/Enable fridge. A drop down menu will
shown. Select the instrument model:
• Analizer with or without fridge.

5.3. Tests
Various tests make it possible to check that the different components of the analyzer function correctly.

5.3.1. Motor tests

Through these tests, the technician can check the correct functioning of all the analyzer motors step by step.
The screen makes it possible to choose the motor to be tested and the test that is to be carried out. The analyzer
uses the following motors step by step:
• X axis of the operating arm.

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• Y axis of the operating arm.


• Z axis of the operating arm.
• Dispensing pump
• Rotor
• Filter wheel
All the motor tests can be performed without the covers and housing of the analyzer. After the verifications,
the operating arm always returns to its resting position. To test the motor of the dispensing pump, the arm is
positioned over the washing station. It is convenient for the dispensing system to be primed so that the piston
does not function dry. The following is a description of the different tests that can be performed.

5.3.1.1. Initialization test

This test verifies the start detector of each of the motors.

5.3.1.2. Movement test

This test displaces any of the mobile components to the desired point along its range of functioning, introducing
the corresponding absolute coordinate or moving it step by step. The speed and acceleration of the movement
are those used in the normal functioning of the analyzer.

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5.3.1.3. Loss step test

This test makes it possible to check if a motor misses steps when performing a certain sequence of movements.
The test can be carried out with the speed and acceleration used in the normal functioning of the analyzer or
with these magnitudes increased by 10% to check the functioning safety margin.

5.3.1.4. tress mode test

This test makes it possible for a certain sequence of movements to be performed continually. The technician
can program the duration of the test, which can be cancelled at any moment. Depending on the motor selected,
there is a minimum stress mode time (but in no case is it higher than 50 seconds).

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5.3.1.5. Z axis secu­ri­ty systems test

The Z axis of the operating arm has an encoder to detect if there have been missed steps as a result of a co-
llision with the needle. In the case of a power failure, a mechanical system automatically raises the needle. On
selecting the corresponding options, the analyzer checks the functioning of each of these devices.

5.3.1.6. Maximum Z verification test

This test checks that the needle does not collide with the bottles on the rack tray. Select the rack type (reagent,
paediatric, 30 mm or 15 mm, stool tube), the position of the rack on the tray and the position of the bottle or
well on the rack.
Press the Start button to move to the selected position and check if the needle collides with the bottle or well
or if there is space between the needle and the bottle.
Repeat the process in the positions required by the user.

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5.3.2. Diaphragm pumps and electrovalves test

The analyzer uses a 3-way electrovalve to manage the dispensing operations. The washing system of the needle
uses a 2-way electrovalve and two diaphragm pumps. The screen makes it possible to choose the device to be
tested and the test that is to be carried out. The devices that can be tested independently are:
• 3-channel electrovalve of the dispensing pump.
• 2-channel electrovalve of the washing system.
• Washing system diaphragm pumps
To carry out these tests, the dispensing system should be primed. The following is a description of the different
tests that can be performed.

5.3.2.1. Functioning test

This test makes it possible to manually switch the selected device.

5.3.2.2. Stress mode test

This test makes it possible for a certain sequence of device switching to be performed continually. The technician
can program the duration of the test, which can be cancelled at any moment.

5.3.3. Needle self-centering system test

This test makes it possible to check the functioning of the needle self-centering system. During its initialisation,
the analyzer uses this system to check the presence of the needle and its verticality and automatically correct
small deviations. The test consists of simply running this process. The technician can remove the housing of
the arm to observe the test. On the finalisation of the test, the program shows the deviation (x, y) found in the
motor steps.

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5.3.4. Needle level detection system test

This test checks the functioning of the system for detecting the capacitive needle in bottles of reagent, pediatric
well, sample tubes and stool tubes.
This test checks the functioning of the system for detecting the capacity of the needle in reagent bottles and
sample wells. The test can be performed in any position on the tray.
First select the rack type, then the position of the rack on the tray and, finally, the position of the bottle/well on
the rack. Press the Test button and the program will move the arm to the indicated position and check whether
or not liquid is detected, depending on whether the bottle is full or empty.
Repeat the test as many times as the user considers necessary.

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5.3.5. Needle thermostatation system test

This screen makes it possible to check that the dispensing temperature of the reactions is around 37ºC. To make
this adjustment, the analyzer must be initialised. The technician must measure the temperature of the dispen-
sed liquid with a thermometer calibrated at 37ºC. The program shows the set point temperature of the current
control. This parameter must be different from 37ºC. When the technician so indicates, the analyzer dispenses
thermostated distilled water on a certain position in the racks tray shown on the screen. The technician must
measure the temperature of the water with the calibrated thermometer and introduce the temperature on the
screen. The program indicates if the temperature measured is within the tolerated error margins and stores this
value for the test result reports. The liquid to be dispensed is taken from the system liquid container or from the
bottle of reagent selected by the technician.

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5.3.6. Needle rotor thermostatation system test

This screen makes it possible to check that the temperature of the rotor reactions is 37ºC. To make this test, the
analyzer must be initialised. The methacrylate rotor can be automatically filled with distilled water by pressing
the corresponding button. Once filled, the technician must wait a few minutes for the rotor to be thermostated.
The temperature in the rotor wells must be measured with a temperature calibrated at 37ºC through the dis-
pensing hole of the rotor cover. A button makes it possible to turn the rotor in increases of 15 wells to change
the well on which the measurement is being taken. The program shows the set point temperature of the current
control. This parameter must be other than 37ºC. The technician must measure the temperature of the water
with the calibrated thermometer in the wells and enter the temperature on the screen. The program indicates if
the temperature measured is within the tolerated error margins and stores this value for the test result reports.

5.3.7. Photometry tests

This screen contains a set of tests to check the functioning of the optical system. The tests are classified under
different tabs. First of all, the base line and darkness count tests must be made in order to be able to carry out
the remaining tests. To perform these tests, the analyzer must be initialised.
The optical system has a photodiode that generates an electrical current proportionate to the light intensity on
it. time. An AD converter converts the accumulated load into a digital value called count number, between 0
and 1048576. During normal functioning, the analyzer automatically adjusts the integration time for each filter
when the analysis begins and after initialisation. When the first photometry test is performed, the integration
times are also automatically adjusted. These times are adjusted in such a way that the count number of the
base line for each wavelength is as near as possible to 950000. In this way, the dynamic range of the detection
system is adapted to the light intensity present at each wavelength. The filter wheel has 10 positions. Position
0 must always contain a covered filter so that the analyzer can perform the darkness adjustment. Positions 1
to 9 can be used for optical filters.

5.3.7.1. Base line and integration times

When this test is run for the first time, the analyzer fills the first 3 rotor wells with distilled water. The analyzer
automatically adjusts the integration times and makes a base line with each of the available filters in each of
the 3 wells. The program shows the current integration times for each of the filters and the average for the 3
wells of the count numbers obtained with each filter. The screen shows the corresponding alarms in the case
of anomaly. It is also possible to access a screen where it is possible to manually vary the integration times

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to check their effect on the count numbers. And another screen where it is possible to assign calculated in-
tegration times as reference integration times for each filter. This screen is recommended when a filter or the
lamp is physically changed. After performing the test, the analyzer continues to take optical readings using the
automatically adjusted integration times.

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5.3.7.2. Darkness counts

The program shows the current integration times for each filter. On running the test, the analyzer positions the
covered filter and measures the darkness counts with each of the integration times. Each time an optical reading
is taken, the analyzer subtracts these darkness counts from the count numbers measured to obtain the light
intensity. The program shows the values obtained and issues the corresponding alarms in case of anomaly.
The values should be around 4100 - 4300. All the count numbers shown by the tests given as follows have the
darkness counts subtracted.

5.3.7.3. Repeatability without moving the filter wheel

To perform this and the following tests, the base line and darkness count test must have first of all been perfor-
med. This test takes absorbance readings during 1 minute with the filter wheel in fixed position. The technician
can choose the rotor well on which he wishes to take the readings and fill it with the liquid he desires. He can
choose which wavelength he wishes to use. The test can also be performed with the filter covered. When the
readings end, the screen graphically displays the count numbers obtained and the absorbances with regard to
the corresponding base lines. The program also shows the averages and/or standard deviations of the count

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numbers and the absorbances.

5.3.7.4. Stability

This test takes absorbance readings during 30 minute with the filter wheel in fixed position. The technician
can choose the rotor well on which he wishes to take the readings and fill it with the liquid he desires. He can
choose which wavelength he wishes to use. The test can also be performed with the filter covered. The test can
be cancelled at any time. When the readings end, the screen graphically displays the count numbers obtained
and the absorbances with regard to the corresponding base lines. The program also shows the averages and/
or standard deviations of the count numbers and the absorbances.

5.3.7.5. Repeatability moving filter wheel

This test takes absorbance readings during 10 minute moving the filter wheel randomly. The technician can
choose the rotor well on which he wishes to take the readings and fill it with the liquid he desires. The test can
be cancelled at any time. When the readings end, the screen graphically displays the count numbers obtained
and the absorbances for each filter with regard to the corresponding base lines. The program also shows the

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averages and/or standard deviations of the count numbers and the absorbances for each filter.

5.3.7.6. Absorbance measurement

This test enables individual absorbance readings. The technician can choose the rotor well on which he wishes
to take the readings and fill it with the liquid he desires. He can choose which wavelength he wishes to use.
The screen shows the count number obtained, the absorbance with regard to the corresponding base line, the
value of the base line.

5.3.7.7. Reactions rotor check

The user can use this test to check the optical status of a reactions rotor. He or she can choose the optical filter
with which the test is to be performed. The technician must place the rotor in the analyzer and press the Test
button. If the Automatic Fill option has been chosen, the analyzer fills the 120 rotor wells with distilled water
and then makes a base line on each well with the chosen filter. The analyzer graphically displays the absorban-
ces related to the average of all the wells and tells the technician the state of the rotor (optimal, adequate or
unusable). After the test, the user must remove the rotor of the analyzer, empty it and dry it completely before
using it for analyses.

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5.3.8. Level control scales test

This screen makes it possible to check the functioning of the level control scales of the waste and distilled water
containers. The technician must select which scales he wishes to check and place a certain amount of liquid
in the corresponding container. On pressing the Test button, the screen shows the level of liquid measured by
the analyzer(only 0 % and 100%).

5.3.9. Covers detection test

This test makes it possible to check the functioning of the different detectors incorporated in the analyzer.
- Open detector of the general cover of the analyzer.
Rotor cover presence detector.
The technician can manipulate the corresponding components, for example, open and close the cover of the
analyzer and the screen shows the state of the detectors in each case.

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5.3.10. PC-Analyzer communications channel test

On pressing the Test button, the computer attempts to establish communication with the analyzer. The program
tells the technician if it has been possible or not.
The technician can select Automatic Configuration or Manual Configuration. In the case of the latter, he can
define the Port and the Speed.

5.3.11. Global stress mode of the analyzer

This test makes it possible to continually reproduce work cycles of the analyzer similar to those made during
the preparation and reading of reactions in a normal working routine, but dispensing at the washing station
instead of the rotor. It is necessary for the dispensing system to be primed so that the piston does not function
dry. All the racks must be removed from the racks tray. This test can be made without the covers and housing

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of the analyzer. The technician can program the number of cycles he wishes (1 cycle = 15 seconds). The test
can be cancelled at any time.
Once the test has been launched, the screen provides regular information about the current status of the pro-
cess. If an error occurs during the process, the test ends and the screen displays a message indicating the
element causing the error.
Partial stressing of the elements of the analyser is possible. The following elements can be stressed partially:

• X axis
• Y axis
• Z axis
• Reactions rotor
• Filter wheel
• Dispensation pump
• Membrane pumps
• 2-way electrvalve
• 3-way electriovalve

5.3.12. Photometry tool

This option is used with the Photometry tool (AC15222). It is used for automate the reading process of the tool.
To use the photometry tool folow the next stetp:
1. Switch on the analyzer.
2. Run the service programme. (The older version to use the tool is the 4.1)
3. Left the analyzer switch on initialized with the service programme for 20 minutes, to preheat the lamp.
4. Select the test menu and Photometry tool option.
5. Press the Load Parameters button.
6. Insert the CD-ROM and select the file ReferenciaUtilFotometria.bin. Push Accept button.
7. Insert the tool (1) in the place of the rotor.
8. Press the Read ABS button.
9. Press the Report button to print the results report.

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5.4. Utilities
The program contains various technical utilities. These utilities are also accessible from the user program.

5.4.1. Disassembly of the dispensing needle

On clicking on the Disassemble Needle button, the operating arm positions itself over the rack tray. The program
alerts the technician to remove any object positioned under the arm. On clicking OK, the needle descends
and the technician can remove it to work with it or change it. To remove the needle, unscrew it by holding the
top fitting. If, while handling the needle, the carriage rises due to the pressure made by the technician, press
the Lower Needle button for the needle to descend once again. Once the needle has been reassembled on
the analyzer, press the Park button for the needle to rise. It performs the self-centering test and the arm finally
returns to its parked position. These operations must be done with utmost care since they are carried out with
the analyzer cover open and the needle may be contaminated. Laboratory gloves must always be used.

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5.4.2. Fluid system supply

On pressing the Test button, the analyzer fills the conduits of the dispensing system and the washing station
with distilled water. To perform this operation, the operating arm is moved to the washing station. The technician
can choose whether he wishes to prime the dispensing system, the washing system or both.

5.4.3. Cleaning of the dispensing system

On pressing the Wash button, the analyzer washes the dispensing system internally and externally. To perform
this operation, the operating arm is moved to the washing station. The technician can choose between performing
the wash with distilled water or wash solution. In the case of the latter, the analyzer asks the technician to place
a bottle of wash solution in stead of the distilled water container or to fill the latter with wash solution. Once the
wash has been performed, the analyzer asks for the distilled water container to be put back in position. Finally,
the analyzer primes the system with distilled water.

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5.4.4. Changing the lamp

When entering the screen, it is possible to choose between: Changing or checking the lamp. When a new
lamp is installed, this utility must be used to notify the analyzer that the lamp has been changed and optimize
the luminosity of the photometric system. The lamp must be changed with the analyzer in sleeping mode. If
the analyzer is on standby mode, the program shuts it down automatically. The lamp must never be touched
with fingers. Once the new lamp has been installed and the covers of the optic and rotor put back, access the
change lamp utility and press the Test button. The program starts up the analyzer, checks the light intensity of
the optical system, shuts down the analyzer and then requests the technician to remove the lamp holder again
and replace it again turning it 180º on the axis of the lamp. If the temperature of the lamp holder is high, wait until
it cools down or use pincers to hold it. The program starts up the analyzer again, measures the light intensity
of the optical system again, compares the light intensity in both possible positions and chooses the greatest
luminosity. If it is the current position, it tells the technician that the test is complete. If the best position were
the previous one, the program shuts down the analyzer and asks the technician to remove the lamp holder and
replace it, turning it 180º on the axis of the lamp, returning the lamp to its initial position. If the option selected
at the beginning was to Check the Lamp, the process is the same but without shutting down the analyzer at
the beginning.

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5.4.5. Configuration of the filter wheel

This screen enables the modification of the analyzer filter wheel. The wheel has 10 positions. Position 0 must
always contain a covered filter so that the analyzer can perform the darkness adjustment. Positions 1 to 9 can
be used for optical filters. All the positions of the wheel must be occupied for it to work correctly. The positions
that do not contain an optical filter must be occupied by a covered filter. The analyzer includes as standard 8
optical filters in positions 1 to 8 and two covered filters in positions 0 to 9. If one of the filters is to be changed,
select the desired position of the wheel and press the Change Filter button. The analyzer automatically posi-
tions the filter wheel appropriately so that the technician can change the filter through the window of the optical
system. Next, if it is different, introduce the wavelength of the new filter that has been installed. If the filter is
covered, introduce value 0. On closing the screen, the analyzer asks if the filters have actually been physically
changed and a series of warnings are given to the technician telling him he must bear in mind whether or not
he has changed a filter.

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5.4.6. Demonstration mode

On pressing the Start button, the analyzer activates some of its mobile components, imitating functioning during
a work routine. The activated mechanical components are the operating arm, the reactions rotor and the filter
wheel. On pressing the Cancel button, the analyzer finishes the current cycle and returns to its rest position.

5.4.7. Read/load adjustments and cycles

From this screen, it is possible to read the current adjustments that the analyser is using by pressing the button
Read Adjustments.
It is allowed to save these adjustments in a file. The technician selects the name and location of this file.
Also from this same screen and with the button Load Adjustments, the technician is allowed to select an ad-
justment file and to load it in the analyzer. Once the adjustment loading is made, the analyser turns off and
the application is closed. When reinitiating the application, the new loaded adjustments will be already active.
From the firmware version 2.80, the programme counts the number of cycles of each element and the task of
the analyser. From this menu, it is possible to read the cycles completed by the analyser. The screen displays
the said cycles with the corresponding units.

The programme automatically saves a copy of the adjustments and cycles read in a file. This file is located in
the following folder:

c:\Program files\A15 Service\Adjustments\

When a physical element of the analyser has to be changed, e.g. the Z axis belt, the counter must be reset
to zero for it to correspond to the number of cycles actually stored in the analyser. To perform this operation,
select the box of the element that is to be initialised and enter the number of cycles in the enabled box. Then
press the Load cycles button.
Using the Load adjustments button, this screen also enables the technician to select an adjustments file and load
it in the analyser. When the adjustments are loaded, the cycles are also loaded. Perform this operation when
a CPU board has to be changed. This avoids having to completely readjust the analyser; only the following
sections will have to be readjusted:
• Scales

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• Level detection sensitivity
• Needle thermostatation
• Rotor thermostatation

5.4.8. Change the rotor type

In this screen the type of rotor is introduced. Each rotor comes labelled with a letter in its top part. Select in
this screen the type of rotor to use. For rotors marked with A letter, only select the letter. For the rotors marked
with other letters, select OTHERS and then introduce the light path that will come it within the box of rotors or
of the distributor.

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5.5. Register
This enables the management of past adjustments, tests, incidences, repairs and maintenance of the instrument.

5.5.1. Introducing the analyzer serial number

The technician can enter the analyzer serial number so that it appears on printed service reports. If an ente-
red serial number is changed, the service records are reinitiated. In this case, the technician can store all the
previous data in a file.
The technician can enter his name so that it appears on the printed service reports.

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5.5.2. Service Reports

The program can display and print various service reports. The printed reports contain the analyzer serial number
and the name of the current technician.
Reports are stored organised by: Adjustments, Tests, Utilities, Monitor and Summary of actions and tasks
carried out.
In all cases, it is possible to select the actions carried out within a range of dates chosen by the technician.
The technician can enter short descriptions of the incidences that may happen in the analyzer and the repairs
and maintenance operations that may be performed to the instrument in the Observations box.

5.5.3. Language change

This makes it possible to choose the language used in the service program.

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5.5.4. Users

Two types of user can be created with different access levels:


• SAT. This user has full access to the programme. This user has permission to create and/or delete other
users.
• User. This user has restricted access to the programme. This user can only perform the tests and run the
utilities. He/she can not make any adjustments or load any previously saved adjustments files or change
the firmware version of the analyser.

From the Users menu, it is possible to create, delete and change users. The Change password option is for
each user to change his own password.

5.6. Monitor
These enable the low level communication with the analyzer to load new versions of the program in the flash
memory of the analyzer (firmware) or to restore the default adjustment parameters.
The firmware of the analyzer resides in a permanent flash memory. The change of this program can be made
through the computer without the need for changing the memory chip. Once the program has changed, the
analyzer is restarted with the new version of the program. While the copy process is being performed, the screen
indicates the percentage completed. To load the new version, press the Start button, previously indicating where
the program is located using the Open button. First of all, the current content of the flash memory is deleted
and then the new program is loaded. This operation may take several minutes.
There is also the option to Restore Default Adjustments, selecting the option and pressing Start.
If the technician wants the analyzer to enter monitor mode (e.g. because the analyzer does not respond because
the firmware was incorrectly loaded, he may do so by shutting down the analyzer, pressing the Force Monitor
button and then rebooting.
Once the new programme has been loaded or the default adjustments have been restored, exit the monitor by
pressing the Close button.

5.7. User’s program


In this section, the service options in the user program will be described. These options are intended to confi-
gure the user’s access level.

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Each section explains how to manage and create different levels of access to the user program of the analyser.
When the program is installed for the first time, there is not a created user and access to the program is complete.

5.7.1. Configuration of the level of access to the analyser

To activate the option of level of access to the analyser, the first time you should enter as administrator, whose
values are:

Name of user: admin


access key: A15

with this screen, the application with the operation by passwords is configured.
The first time that the program is activated, it forces the user to change the initial password.
It is possible to create three types of user with different access levels:
• Operator, is the user with a lower level of access to the application. He can only do working sessions, reports
of current and historical results, and validate quality control results. In the screens of programming of techniques
and contaminations, he can look up programming values, but he can not modify any parameter. He can not
delete results or alarms. This user has total access to the rack and profile programming and to the analyser’s
configuration (except for changes of filters). He can change his own password.
• Supervisor, is the user with a medium access level. This user has got the same privileges as the operator
user’s and, in addition, he has got permissions to modify the programming of techniques in the calibration
parameters and the control values. He can create a restricted number of new techniques, that is defined at
the moment of creating such user and that it is a default setting of 5. He can also modify the programming of
contaminations and change the analyser’s filters. He can change his own password.
• Administrator, is the user with total access to the analyser’s functions. He can create new users -as much at
supervisor as at operator level-, eliminate or modify users. When creating supervisor users, he has to indicate
the maximum number of new techniques that can create. He can activate or deactivate Work Without Passwords
(option within the Configuration menu). He can also activate/deactivate the working without cover detection
(this option is useful for the technical service to make verifications without needing to let the cover down). This
option activates solely when the passwords are active.

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When users are created, the access is limited to different parts of the program. When starting the program, an
identification of the user is requested, by the user name and a password, and then the program will automatically
restrict the different parts of the program depending on the access level permitted.
Whenever you want, you can change the user by means of the option Change of user from the User menu.
It is also allowed to eliminate users already created. Each user is capable of changing his password. All these
options can be reached from the user menu.

5.7.2. Reagent Consumption

In order to access the consumption of reagents, it is first necessary to configure the program with the option
of working with passwords. The administrator user is the only one that can access this menu -this option is
deactivated for any other user.
In order to generate a list of the consumption of reagents, the administrator has to introduce the dates between
which he wants to know the consumption. For this, it appears a screen like this:
Such option creates two files of results, one in text format .txt and the another one in excel format .xls. These
files will be located at directory within the application directory, it will usually be:

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Location of the folder up to version v5.4
c:\Program Files\A15\Reagents

Location of the folder from version v5.5


c:\Users\Public\Documents\A15\Reagents\

and the contents of the file shows similar this:


REAGENT CONTROL CONSUME REPORT

Initial Date: 02/11/2004 Final Date: 02/12/2004

Test Blank Prep. Calibrator Pre Control Prep. Patient Prep. Total Prep. Vol. R1 (uL) Vol. R2
(uL)
glucose 1 0 0 5 6 1332 0
alt 1 0 0 3 4 888 0
bilirrubin 9 0 0 23 32 7104 3552
Reagents

5.7.3. Location of the different software files

Here is where to locate the different files used by the software.

Address of the folders Description


c:\Program Files (x86)\A15\ Software installation folder
c:\Program Files (x86)\Y15\
c:\ProgramData\A15\ Folder where the databases and files generated
c:\ProgramData\Y15\ by the software are saved
c:\Users\Public\Documents\A15\ReportSAT Folder where the ReportSAT are saved
c:\Users\Public\Documents\Y15\ReportSAT
c:\Users\Public\Documents\A15\RestorePoints\ Folder where the RestorePoints are saved, The
c:\Users\Public\Documents\Y15\RestorePoints\ RestorePoint is a backup of the database

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Address of the folders Description


c:\Users\Public\Documents\A15\Reagents\ Folder where reagent consumption files are stored
c:\Users\Public\Documents\Y15\Reagents\
c:\Users\Public\Documents\A15\Export\ Folder where the export files are saved
c:\Users\Public\Documents\Y15\Export\
c:\Users\Public\Documents\A15\Import\ Folder where the import files are saved
c:\Users\Public\Documents\Y15\Import\

To be able to access the folder of c:\ProgramData, you have to change the hiding folder option of the operating
system, for this follow the following steps, See Figure 5.1:
• Open windows explorer
• Select the View menu option
• Select the option of hidden files

Figure 5.1 Screen to configure hiding folder options

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6. Spare parts explanation

6.1. Hosing and cover

6.1.1. AC17350 - Lower arm housing / AC17349 - Upper arm housing

Disassembly:
1. Remove the side screws that hold the housing (1).
2. Pull the upper housing
3. Pull down the bottom housing, be careful with the tip not to bend it

Mounting:
1. Place the bottom housing
2. Place the 4 screws (1) that hold it
3. Place the top housing
4. Place the 4 screws (1) that hold it

Ilustración 6.1 Disassembly tip housing

6.1.2. AC17352 - Front housing

Disassembly:
1. Remove the 2 cable glands that guide the cables (2)
2. Remove the 4 screws that hold the housing (3).
3. Remove the front cover by pulling up and forward

Mounting:
1. Attach the front cover
2. Install the 4 screws (3) that hold the front cover

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3. Place the cable glands (2) that guide the cables in their housing

Ilustración 6.2 Disassembly front housing

6.1.3. AC173545 - General instrument cover

Disassembly:
1. Remove the 2 screws that hold the cover (4).
2. Extract the cover by pulling up

Mounting:
1. Place the cover
2. Place the 2 screws (4) that hold the cover

Ilustración 6.3 Disassembly main cover

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6.1.4. AC17318 - Refrigerator housing

Disassembly:
1. Remove the refrigerator lid and all reagent bottles
2. Remove the 4 screws that hold the housing
3. Take out the housing a little
4. Disconnect the 2 cables from the cover sensor and the status led
5. Removing completely the refrigerator housing

Mounting:
1. Install the refrigerator housing
2. Connect the two cables of the cover sensor and the status led
3. Put the 4 screws that hold the refrigerator housing

Ilustración 6.4 Disassembly the refrigerator housing

6.1.5. AC17349 - Upper housing

Disassembly:
1. Extract the main cover. See chapter 6.1.3
2. Remove the front cover. See chapter 6.1.2
3. Remove the refrigerator housing. See chapter 6.1.4
4. Remove the rotor cover and manually move the arm into a centered position.
5. Remove the 6 front screws (6) and the 5 rear screws (7) that hold the housing.
6. Remove the casing by lifting it

Mounting:
1. Put on the new top case

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2. Follow the steps in reverse order

Ilustración 6.5 Disassembly the upper housing

6.1.6. ME13377 - Hydro-pneumatic hinge cylinder

Disassembly:
1. Remove the upper case. See chapter 6.1.5
2. Remove the 2 screws (9) and (10) and the nut (8)
3. Extract the piston

Mounting:
1. Install the new piston
2. Follow the steps in reverse order
3. Place the main cover and check that it slides smoothly and does not fall when it is in the upper position

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8

10

Ilustración 6.6 Disassembly the piston

6.2. Manipulator arm

6.2.1. MO13351 - Motor X

Disassembly:
1. Remove the upper case. See chapter 6.1.5
2. Remove the interconnect board. See chapter 6.5.1
3. Remove the 4 screws (1) that hold the motor (2)
4. Remove X motor

Mounting:
1. Put the new X motor
2. Place the 4 screws (1) to hold the motor loosely
3. Tighten the motor pinion with the linear rack and then tighten the 4 screws (1)
4. Place the interconnect board and housing
5. Carry out some stress cycles with the service program to verify that the assembly has been carried out correctly

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Ilustración 6.7 Disassembly X motor

6.2.2. MO13353 - Y Motor / ME13352 - Y Belt

Engine disassembly:
1. Remove the upper case. See chapter 6.1.5
2. Disconnect Y motor cable
3. Remove the 4 screws (5) with their washers that hold the motor (3)
4. Remove the Y motor from hoding plate (4)

Belt removal:
1. Remove the belt from the counter pulley

Belt mount:
1. Put on the new belt, placing it first on the counter pulley
2. Follow the Y motor mounting instructions

Y motor mount:
1. Place the new Y motor (3) with the holding plate (4) and the belt on the pulley
2. Place the 4 screws (5) with the washers to hold the motor loosely
3. Tighten the belt by displacing the motor and then tighten the screws (5)
4. Place the cover
5. Carry out some stress cycles with the service program to verify that the assembly has been carried out correctly

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3

Ilustración 6.8 Disassembly Y motor

6.2.3. MO13354 - Z motor / AC13765 Z axis encoder

Encoder removal:
1. Remove the upper case. See chapter 6.1.5
2. Loosen the 4 grub screw (8) that hold the encoder (9)
3. Pull out the shaft (10) to release the encoder

Encoder removal:
1. Remove the encoder first
2. Remove the 4 screws (6) that hold the motor (7)
3. Disconnect Z motor cable
4. Remove the 4 screws (8) that hold the encoder (9)
5. Extract the motor to the side (7)

Motor mounting:
1. Fit the new Z motor
2. Place the 4 screws (8) to hold the motor (7)
3. Place the encoder (9)

Encoder mount:
1. Place the encoder on the motor (7) and the shaft (10)
2. Adjust the encoder to be centered with the photodetector
3. Tighten the 4 grub screw (8)
4. Carry out some stress cycles with the service program to verify that the assembly has been carried out correctly

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10

Ilustración 6.9 Disassembly Z motor

6.2.4. ME13355 - Spring set

Disassembly:
1. Remove the upper case. See chapter 6.1.5
2. Remove the Y-belt. See chapter 6.2.3
3. Remove the 2 screws (12) that hold the Y axis
4. Remove the 2 screws (11). Be careful and unscrew strongly when loosening the screws because they have
threadlocker.
5. Remove the spring assembly.

Mounting:
1. Place the spring assembly
2. Fit the 2 screws (11) without tightening them. Before tightening them, check that the 2 axes are perfectly aligned.
3. Tighten the motor pinion with the linear rack and then tighten the 4 screws (1)
4. Place the belt and tighten it. See chapter 6.2.3
5. Put the 2 screws (12) loosely.
6. Tighten the spring:
a. Keep the probe set in the upper position
b. Using a wrench, turn the pulley counterclockwise. Make 3-4 laps
c. Tighten the screws (12), matching with the flat part of the shaft.

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11

12

Ilustración 6.10 Disassembly spring

6.2.5. AC14307 - Arm cables / AC13360 - Tip clamp fitting

Cable disassembly:
1. Remove the upper case. See chapter 6.1.5
2. Unscrew the clamping fitting (14)
3. Cut all the ties that hold the tube and cables
4. Disconnect the Teflon tube at both ends (tip and electrovalve) (13)
5. Disconnect the connector that goes to the CPU board and the grounding
6. Remove the cables from the arm

Disassembly fitting tighten:


1. Remove the upper case. See chapter 6.1.5
2. Unscrew the clamping fitting (14)
3. Disconnect the Teflon tube from the thermostat tip
4. Remove the clamping fitting.

Fitting fitting or hose:


1. Replace the faulty element
2. Follow the steps in reverse order
3. Carry out some stress cycles with the service program to verify that the assembly has been carried out correctly

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13

14

Ilustración 6.11 Arm cable removal

6.2.6. AC13356 - Thermostat tip assembly

Disassembly:
1. Remove the arm housing. See chapter 6.1.1
2. Remove the tip
3. Extract the tube from the top of the board
4. Remove the 3 screws (15), also remove the nuts on the other side and the protection plate
5. Remove the tip plate

Fitting fitting or hose:


1. Replace the board with a new one
2. Follow the steps in reverse order
3. Verify Z-axis movement is smooth and without any blockage
4. Carry out some stress cycles with the service program to verify that the assembly has been carried out correctly

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15

16

Ilustración 6.12 Disaasmebly the tip board

6.3. Dosing system

6.3.1. AC17316 - Manifold

Disassembly:
1. Unscrew the 4 screws (1) and separate the manifold (2) from the rest of the pump.
2. Carefully stretch the manifold to remove the piston from the seals that comes with the manifold.
3. Turn over the manifold and unscrew the 4 screws (3) to separate the parts holding the chamber (4), the O-ring
(5), the bubble suppressor (6) and the adapter seal with the seal (7).

Mounting:
1. Replace the manifold.
2. Orient each part correctly (9) according to Illustration 6.14
3. Rotate the manifold holding the pieces (14).
4. Verify that the O-ring (14) is clean. Put it in your accommodation. Check that it has been inserted correctly and
does not come out of the guides (15). See Illustration 6.15
5. Check that the bubble suppressor (16) is free of burrs and dirt. Place it on top of the O-ring. Once assembled,
verify that the O-ring is not visible. See Illustration 6.15
6. Orient the seal and seal adapter (17) correctly. The flat face of the adapter must coincide with the window of the
manifold (18). See Illustration 6.16
7. Screw in the 4 screws (19) with a tightening torque of 30 Ncm and crosswise. See Illustration 6.16
8. Lubricate piston and seal with WS (Washing Solution)
9. Orient the manifold correctly with the pump. The window of the manifold (21) has to coincide with the guide screw
(22) of the pump. See Illustration 6.16
10. Insert the piston into the seal
11. Tighten the manifold against the pump, position the 4 screws (20) and cross tighten with a torque of 60 Ncm.
12. Mount the pump on the instrument. Connect the motor and home detector cable. Connect the tubes
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13. Check the operation of the pump with the service program.

4
1

5
6

7
3

Ilustración 6.13 Disassembly of the manifold

Ilustración 6.14 Disassembly / assembly of manifold clamping parts

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8

10

Ilustración 6.15

11
13

12

Ilustración 6.16

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14

15

16

Ilustración 6.17

6.3.2. AC11527 - Piston seal

Tools:
Disassembly:
1. Follow the disassembly steps according to chapter 6.3.1
2. Detach the seal (17) from the seal adapter (11).

Mounting:
1. Follow the mounting steps according to chapter 6.3.1
2. Before performing point 7, replace the seal (17) with a new one. Dampen the seal adapter and seal with WS
(Washing Solution) to facilitate insertion of the seal into its housing. Use a flat piece to press the seal.
3. Verify the seal is properly leveled with the seal adapter.
4. Continue the assembly steps according to chapter 6.3.1

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17

Ilustración 6.18

6.3.3. AC16594 - Ceramic piston + motor

Tools: 2 and 3 Allen wrench and 7 open end wrench, ceramic pump grease
Disassembly:
1. Follow the disassembly steps according to chapter 6.3.1
2. Remove the home detector.
3. Remove the 4 screws with nuts that secure the pump body (18) with the motor.
4. Pull out the pump body (18).

Mounting:
1. Replace the defective part.
2. Unscrew the piston support from the spindle to grease the thread.
3. Grease the guide of the piston support. Put enough grease in the hole in the bracket where the spindle enters.
4. Screw in the piston support with the spindle. Wipe off excess grease with a cloth.
5. Place the pump chamber. Align the groove in the bracket (20) with the body anti-rotation system (19).
6. Install the screws and nuts to secure the body with the motor.
7. Place the home detector.
8. Follow the manifold mounting steps according to chapter 6.3.1

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18

19

20

21

Ilustración 6.16. Lubricating the spindle and mounting the pump body

6.3.4. ME13367 - Waste pump

Disassembly:
1. Remove the upper case. See 6.1.5
2. Remove the connection tubes from the pump and the connector
3. Remove the 3 screws (20) that hold the pump
4. Remove the pump (18)

Mounting:
1. Replace the pump with a new one
2. If the analyzer does not have the support plate (19), put it in place with the screws
3. Install the 3 pump retaining screws (20)
4. Connect the tubes to the pump
5. Verify the operation of the washing station with the service program

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18

19

20

Ilustración 6.19 Disassembly waste pump

6.3.5. AC17317 - Manifold tube

Disassembly:
1. Remove the upper case. See 6.1.5
2. Remove the connection pipes from the manifold (21)

Mounting:
1. Replace the tube with a new one
2. Put it in its position
3. Verify operation with service program

21

22

23

Ilustración 6.20 Manifold tubes connection

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6.4. Reaction and reading rotor

6.4.1. AC13370 - Complete reaction set

Disassembly:
1. Remove the upper case. See 6.1.5
2. Disconnect the connection cables to the rotor and remove the lamp holder
3. Remove the 3 screws (1) and (2) that hold the assembly to the base

Mounting:
1. Follow the reverse order to disassembly

Ilustración 6.21 Disassmbly reaction rotor set

6.4.2. AC13371 - Rotor temperature sensor

Disassembly:
1. Remove the upper case. See 6.1.5
2. Disconnect the cables from the temperature probe
3. Remove the thermal insulation from the temperature sensor
4. Remove the temperature sensor (3)

Mounting:
1. Replace temperature sensor
2. Remove the thermal silicone from the housing and put new thermal silicone on the end of the new sensor
3. Fit the new temperature sensor
4. Perform rotor temperature adjustment

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3

Ilustración 6.22 Removing the temperature sensor

6.4.3. AC13373 - Rotor cover detector

Disassembly:
1. Remove the upper case. See chapter 6.1.5
2. Extract the rotor assembly. See chapter 6.4.1
3. Loosen the screw (5) that holds the rotor insulator
4. Remove the grub screw (7) that holds the cover detector
5. Remove the cover detector by stretching from the bottom or with the help of a screwdriver press in the direction
of the arrow (6)

Mounting:
1. Follow the reverse order to disassembly

Ilustración 6.23 Cover detector removal

6.4.4. AC14497 - Rotor Peltier Cells / MO13357 - Rotor fan

Fan disassembly:
1. Remove the upper case. See 6.1.5

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2. Extract the rotor assembly. See chapter 6.4.1


3. Loosen the screw (5) that holds the rotor insulator
4. Remove the 2 screws that hold each fan (8)

Peltier disassembly:
1. Extract the 4 fans
2. Remove the 4 radiators (9)
3. Extract the 4 peltiers. The peltiers are all connected with a single wiring

Peltier mount
1. Clean the silicone residues from the heating and the radiators. Use alcohol.
2. Place a thin layer of thermal silicone on both sides of the peltier (10)
3. Be careful not to put too much silicone so as not to make a thermal bridge with the excess
4. Orient the 4 peltiers as indicated in Illustration 6.26
5. Place each peltier with its radiator (9) with its screws
6. Fit the fans (8) with their screws
7. Make rotor position and temperature adjustments

10

Ilustración 6.24 Dismantling of the peltiers

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11

Ilustración 6.25 Placing the peltiers in the heating channel

6.4.5. MO13372 - Rotor motor

Disassembly:
1. Remove the upper case. See 6.1.5
2. Extract the rotor assembly. See chapter 6.4.1
3. Remove the 4 screws (12) that hold the upper rotor plate
4. Remove the 2 nuts (13) that hold the motor
5. Separate the motor assembly (14) from the heating channel
6. Remove the 4 screws (15) to separate the motor (16) from the spacer

Mounting
1. Assemble in reverse order of disassembly
2. Before tightening the nuts (13), adjust the separations between the gear and the pinion.
3. Tighten the nuts
4. Check the movement of the gear with the pinion. To verify movement, slowly rotate one full turn of the crown and
verify that the crown is never blocked with the pinion. Also check that the crown is not too loose with respect to
the pinion.

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12

Ilustración 6.26 Rotor top plate removal

13

Ilustración 6.27 Rotor motor disassembly

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14

Ilustración 6.28 Rotor motor disassembly

15

16

Ilustración 6.29 Spacer motor spacing

6.4.6. MO13376 - Filter drum motor / AC13375 - Filter drum

Disassembly:
1. Remove the upper case. See 6.1.5
2. Extract the rotor assembly. See chapter 6.4.1
3. Rotate the rotor assembly
4. Remove the 4 screws (17) that hold the protection plate
5. Remove the 2 studs (18) that hold the filter drum with the shaft
6. Remove the 4 screws (19) that hold the motor (21)
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7. Carefully remove the motor (21) by stretching it out


8. Pull out the filter drum

Mounting
1. Place the motor (21) in its location together with the filter drum (20)
2. Match the flat part of the motor shaft with the grub screw position (18). Put threadblocker on
the grub screw thread.
3. Install the screws (19) and tighten them
4. Check that the filter drum rotates freely
5. Put on the protection cap
6. Mount the rotor assembly on the analyzer
7. Make rotor adjustments

17

Ilustración 6.30

18

Ilustración 6.31
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19

Ilustración 6.32

20

21

Ilustración 6.33

6.5. Electronic systems

6.5.1. PC13385 - XYZ interface board

Disassembly:
1. Remove the upper case. See chapter 6.1.5
2. Disconnect the cables from the board
3. Remove the 4 screws (1)
4. Remove the protection plate and the connection board

Mounting:
1. Place the new board
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2. Follow the steps in reverse order


3. Carry out some stress cycles with the service program to verify that the assembly has been carried out correctly

Ilustración 6.34 Disassembly of interconnection board

6.5.2. PC13386 - Microprocessor board / PC13383 - DC / DC board

Disassembly:
1. Fold down the rear cover of the electronics.
2. Disconnect all the cables from the board.
3. Remove the screws (2) or (3) depending on the board to be removed

Mounting:
1. When reinstalling the board, carefully reconnect all connectors.

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2

Ilustración 6.35 CPU board removal or DC / DC power supply

6.5.3. TR13389 - Main power supply / AC17324 - Refrigerator power supply

Disassembly:
1. Fold down the rear cover of the electronics.
2. Remove the input and output connectors by loosening the screws on the sources (4).
3. Cut the ties (7)
4. Remove the 2 screws (5) that hold the refrigerator power supply.
5. Remove the 5 screws (6) that hold the main power supply
6. Extract the power supply

Mounting:
1. Follow the reverse order to disassembly

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Ilustración 6.36 Disassembling power supplies

5
4

Ilustración 6.37 Disassembling power supplies

6.5.4. AC17323 - Electronic refrigerator plate

1. Fold down the rear cover of the electronics.


2. Remove the connectors (1)
3. Remove the board from the spacers (2)

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2
1

Ilustración 6.38 Removing the refrigerator board

6.5.5. PC13384 - Communications board

Disassembly:
1. Fold down the rear cover of the electronics.
2. Disconnect the cables from the communication board
3. Remove the 6 nuts (1)
4. Remove the communication board

Mounting:
1. Install a new board
2. Perform the reverse disassembly process

Ilustración 6.39

6.5.6. PC13381 - Plate of the photometric system.


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Manual de servicio

Disassembly:
1. Remove the screws (1) from the support cover (2) of the photometric system.
2. Remove the screws (3) from the support cover (4) of the photometric plate.
3. Slightly move the support cover (4) towards the center of the rotor and remove it from its housing.
4. Disconnect the flat band from the photometric system plate.
5. Remove the screws (5) to separate the support cover from the photometric plate.

Mounting:
1. Reinstall the board, carefully reconnect all connectors.
2. Perform the reverse disassembly process

Ilustración 6.40

Ilustración 6.41

132
5

Ilustración 6.42

6.5.7. PC13387 - Pump interconnection plate

Disassembly:
1. Remove all cables from the board
2. Remove the 4 screws (7) that hold the interconnection board (6)

Mounting:
1. Install the new board, carefully reconnect all connectors.
2. Perform the reverse order process

Ilustración 6.43

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Manual de servicio

6.6. Refrigerador de reactivos

6.6.1. Led status indicator and refrigerator lid sensor

To replace the status indicator led or the lid sensor it is necessary to replace the fridge body.

Disassembly:
1. Remove the 4 screws (1)
2. Body Pull (2)
3. Disconnect the connectors (3)

Mounting:
1. Proceed in reverse order to replace the fridge body

1 2 3

Ilustración 6.44

6.6.2. AC17320 - Refrigerator Peltiers / AC17321 - Refrigerator fan

Peltier disassembly:
1. Remove the body from the fridge as explained in chapter 6.6.1
2. Open the electronic cover.
3. Remove the ties (1) and the cover (2) to free the cables that go to the reagent refrigerator. Disconnect all the
connectors that go to the refrigerator board.
4. Close the electronic cover again.
5. Remove the front cover.
6. Remove the ties (3).
7. Remove the general cover of the equipment. See chapter 6.1.5
8. Flip the instrument over so that it rests on its back.
9. Remove the protective plate (4) by removing the screws (5).
10. Remove the 4 outer screws (6) and remove the assembly.
11. Once removed from its housing, remove the ties (7)
12. Unplug the fan connectors (8)
13. Remove the temperature sensor (9) by removing the screw (10)
14. Remove the level detection signal cable (11) by removing the screw (12). Completely remove the fridge together
with the cable from the peltier cells.
15. Once the fridge is completely removed, remove the caps and screws (13), in order to remove the radiators.

134
16. Remove the peltiers (14). Attention remember the polarity of the same and then reassemble the new ones with
the same polarity. Look at the color of the cables.
Fan disassembly:
1. Follow the previous steps up to point 14
2. Remove the faulty fan

Mounting:
1. Clean the surfaces of the radiators (15) and the cold plate (16) of traces of thermal conductor. To do this, first use
a cutter taking care not to scratch the surfaces. Finish cleaning these surfaces with alcohol.
2. Place the thermal conductors (16) on both sides of the peltiers. Remove the paper that protects one of the faces.
Apply heat to this face. It is enough applying a little breath on it. Paste the conductor in the peltier.
3. Place the peltiers in their housing, respecting the polarity. Mount them in the same position that the replaced ones
were. Pay attention to pass the cable through the housing for this purpose (17).
4. Replace the radiators. Tighten the screws evenly in the order shown. Do not overtighten the screws to avoid
damaging the peltiers.
5. Reassemble the refrigerator in its housing. Follow the steps above in reverse order, placing new ties where they
were removed.

1
2

Ilustración 6.45

Ilustración 6.17.

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Manual de servicio

Ilustración 6.46

7
8

10 12

6 11

Ilustración 6.47

14

13

Ilustración 6.48

136
16
15

Ilustración 6.49

17
4 2

1 3

Ilustración 6.50

6.6.3. AC17319 - Refrigerator temperature sensor

Disassembly:
1. Proceed as in chapter 6.6.2 above up to point 13

Mounting:
1. Reassemble the temperature sensor having previously placed a certain amount of thermal silicone.
2. Reassemble the entire assembly following the steps performed in reverse order.

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Manual de servicio

7. Preventive maintenance
In this chapter, firstly it describes step by step the different operations necessary for both preventive maintenance
and repair of the analyzer. Then, it gives some basic recommendations for preventive maintenance of the instrument.
Finally, a series of indications for its care and cleaning are exposed.

7.1. Maintenance and periodicity actions


Actions to be done by the instrument operator.

Actions at the beginning of the day


1 Fill the bottle with liquid system
2 Initialize the analyzer. Warm up with the user program
3 Perform 2 conditioning cycles (only when analyzer is off for several days)
4 Check the reaction rotor temperature
5 Check the volume of the reagent
6 Install the previous day’s rotor or a new rotor.

Actions at the end of the day


1 Turn off the analyzer by performing the Shut-down with the program
2 Empty waste bottle
3 Remove calibrators, controls and samples from the sample rotor
4 Remove the reaction rotor from the instrument. Throw it out if all the rotor wells are used.

Actions to be carried out each semester


1 Clean the work surface
2 Externally clean the aspiration probe with alcohol
3 Clean the insides of the containers of distilled water and waste.

Actions to be done by the technical service people

Annual maintenance
1 Clean electronic boards and fans from dust
2 Check the fluidic connections from the pump to the probe and the connections of the washing
station, Check the tightness of the fittings and that none of them leaks liquid.
3 Check the seal of the dosing pump. Verify that there are no leaks and that no bubbles are produced.
4 Clean the filters in the distilled water container
5 Clean the washing station
6 Disassemble and clean the probe. Check your status.
7 Check the arm (Check the wear of the belts and their tension)
8 Check probe shock detection and protection system
9 Check the condition of the heating channel

138
Annual maintenance
10 Check belt and reaction rotor tension
11 Clean filters, slit and photodiode
12 Check placement and detector of general cover and reaction cover
13 Check that the general cover is properly supported and does not fall.
14 Carry out the tests with the service program

After carrying out any maintenance, make sure that all the elements that have been replaced or dis-
mounted have been correctly assembled.

WARNING

7.2. Care and cleaning

7.2.1. General care of the analyzer

1. Never use detergents or abrasive products for cleaning the surface of the analyzer. Use only a damp cloth with
water and pH-neutral soap.
2. If a reagent or corrosive product spills or splashes onto the apparatus, clean it with a damp cloth and soap imme-
diately. If necessary, protect your hands with appropriate laboratory gloves.
3. All the components of the analyzer have drainage conduits leading to the exterior to enable the elimination of any
liquid spilled and to prevent the apparatus from flooding. If the spillage is significant, the liquid spilled onto the
table through the drainage conduits and the analyzer must be adequately cleaned.
4. When not in use, close the main cover of the analyzer to protect it from dust.

7.2.2. Cleaning the optical system

The components of the optical system must be cleaned periodically in order to keep them free from dust and dirt.
These components are the lamp, the lenses, the filters and the photodiode. The recommended necessary material
is as follows:
• Special paper for cleaning optical components (non-abrasive paper which does not leave solid residue).
• Ether and alcohol solution at 50%
• Cotton wool buds.
• Small bellows.
All the optical components must be handled in an area of maximum cleanliness and with great care given that they are
fragile and delicate. To remove them and refit them, the corresponding instructions given in the Maintenance chapter
must be carefully followed. Avoid touching the useful area of these components with fingers. The lenses, filters and the
photodiode must be held by the sides. Do not touch the lamp bulb. To handle the lamp, use the wrapping, cutting it at
the terminal ends and squeezing them until they come out. To clean the optical components, bear in mind the following
1. Remove the dust on the surface of the component with the bellows. This will avoid scratching by particles when
cleaning with paper.
2. Carefully clean the surface of the component with the cleaning paper.
3. If the dirt is persistent or greasy, clean the component with the paper moistened with the alcohol and ether solu-
tion. Then dry with dry paper. To clean the filters or the window of the photodiode, use the cotton wool buds with
the paper in difficult and delicate areas.
4. Finally, it is recommended that you use the bellows once again, thus removing any remains of paper or cotton.

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Manual de servicio

7.2.3. Cleaning the dispensing system

The analyser automatically performs conditioning of the fluid system at warm-up and shut-down. This conditioning
consists of a 3 primings of the dosing system, the first with air, the second with washing solution and the third and
last with system liquid. To perform this conditioning, the bottles of system liquid (marked with a blue dot) and washing
solution (marked with a green dot) must be full, and the waste bottle (marked with a red dot) must be empty. The final
conditioning consists of performing a priming with washing solution.

With initial wash, the system is ready to work in optimum conditions for the whole workday, offering its best performan-
ce. With the final wash, the analyser cleans the tip at the end of the day’s work, thus keeping it in perfect condition
for the next workdays. The user can also perform conditionings of the dosing system when desired by pressing the
conditioning button in the vertical button bar on the monitor screen while the analyser is in standby mode. It is also
recommended to clean and check the status of the filters of the system liquid container at least once every 3 months.

If the needle is obstructed by solid residue, it must be removed and cleaned using the metal cleaning rod supplied
with the analyzer. For this, the Remove the dispensing needle utility should be used. It is also recommendable to
clean the outside surface of the needle with a piece of cotton or a soft cloth dampened with alcohol. The needle must
be replaced if it is noticeably deteriorated.

7.2.4. General cleaning of the interior of the apparatus

It is important for the interior of the instrument to be free from dust at all times in order to preserve the correct functio-
ning of the different components. For this, remove the front housing of the analyzer and carefully clean the dust inside
the instrument.

7.2.5. Cleaning the reagent cooler

To clean the refrigerator, disassemble the refrigerator body as explained in section 6.1.4 Clean the cold plate with a
damp cloth with water and neutral soap. Clean the body of the fridge in the same way.

7.2.6. Process of analyser verification

This is an standard process for verifying the correct operation of the instrument after doing an intervention.
This process can be applied to the following operations:
• Instrument reception (in the office, before installation)
• Maintenance
• After a repair
The goal is to standarize the verification process and the acceptance criteria.
The duration time of the process is: 1,5 hours

7.2.6.1. Material needed

Use Biosystems reagent and controls or equivalents codes, use always new fresh reconstituted calibrators and controls.

Model A15 / A25


Code Description
21503 / 23503 Glucose 50mL

21531 / 23531 AST-GOT 50+20mL

21518 / 23518 Phosphorus 50+20mL

18011 / 18044 Bovine / Human calibrator 5mL

18009 / 18043 Bovine / Human Control Serum I 5mL

140
Model A15 / A25
Code Description
18010 / 18042 Bovine / Human Control Serum II 5mL
100-1000 µm Pipette (Calibrated)
Disposable pipette tips
Distilled water Type II

Model Y15 / Y25


Code Description
12800 D-Glucose-D-Fructose 50 ml
12810 Acetic acid
12812 Glycerol
12807 PAN
Each kit incorporate each calibrator
12818 Nivel 2 Multical
100-1000 µm Pipette (Calibrated)
Disposable pipette tips
Distilled water Type II

For A15 / A25 models use the template: Results verification.xlsx


For Y15 / Y25 models use the template: Food Quality Verification Results-V1.xlsm
Ask to the service department to get the excel file

7.2.6.2. Process of the verification

1. Use a software version higher than v5.4


2. Load the appropiate sat-report based on analyzer A25/Y25. Tools -> Load Reportsat
3. Do NOT load this sat report in the user PC, do it in another one. You will loose all the history data (results, calibra-
tions, quality controls, etc). Otherwise previously have done a restorepoint and after the verification process load it.
4. Connect and start the warm-up
5. Click on connect button (arrows)
6. Click on warm up button (key)
7. You can prepare all the software and liquids during the warmup time
8. Download the calibration values from the BioSystems website or get them from the “Values sheet”
• www.biosystems-sa.com
• www.biosystems.es
9. If you don’t remember your access or you don’t have, contact customersupport@biosystems.es
10. Use code and lot number to search the “Values sheet”
11. Do a reset session
12. Load the memorized session: “Verification session”. Worksession -> Load worksession, Select “Verification ses-
sion” , Positioning selected samples”
13. Position automatically the samples
14. Position manually the reagent bottles

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Manual de servicio

15. You can use same Distilled water bottle from the customer
16. Look for empty spaces in the rotor. Try not to remove the customer’s reagents form the rotor
17. Fill the cups and bottles with the following liquids, you can fill the cups with more volume, but in that case, you
will not check the correct adjustment of the sample for the dead volume.
18. Position the reagents and samples

Model A15 / A25


Fill the cups with these minimum volume (µL)
for the samples:
Calibrador Calibrator 220
SCI Serum control level I 870
SCII Serum control level II 870
SCII-2 Serum control level II 270
SC-Dummy Distllied water 270

Model Y15 / Y25


Fill the cups with these minimum volume (µL)
for the samples:
Calibrador Glucose-fructose 160
Calibrador Acedit acid 160
Calibrador Glycerol 160
Calibrador PAN 160
Control Multical 500

Place the bottles and the samples in the positions where you positioned them in the software
19. Prepare the washing solution
20. Run the session
21. Export the results
22. When it finishes, go to the test result screen, press the option TEST. Press print current test button
23. Export the current test results in .CSV format
24. Copy the content of the file to the “Data” sheet of the excel file
25. Enter the rest of the data in the “instruction and batch” sheet of the excel file
26. In the “summary” and in the “verification results” you will get all the results and the final result.
27. Save and print the excel file with the serial number as a name. Discard all the rest of the samples and calibration.

142
The following table shows the acceptance criteria of the verification:
Values of the coeficient of variation

Model: A15/A25
GLUCOSE AST PHOSPHORUS
SCI SCII SCI SCII SCII
Tolerance (CV%) 3.00 3.00 5.00 3.00 3.00

Model: Y15/Y25
Glucose-Fructose Acetico Acid Glycerol PAN
N2 N4 N2 N4 N2 N4 N4
Tolerance (CV%) 3.00 3.00 5.00 3.00 3.00 3.00 3.00

Also all the concentration results must be between the range of the control.

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Manual de servicio

Installation sheet record


Laboratory name:

Analyzer Model:

Serial number:

Name of the technical manager:

Instalation date:

Steps Technical service actions Done


1 Location / Analyzer fixing / Leveling
2 Unlocking the manipulator arm
3 Installation of waste containers, system liquid and washing solution
4 Preparation of the washing solution
5 Preparation of the system liquid
6 Reactor rotor installation
7 Connection to the electric power
8 Connecting the communication cable to the computer
9 Installation of the user program on the computer
10 Set up background programs: energy saving, Windows update, ...
11 Install the service program on the computer and launch a stress of 10
min.
12 Verify that the stress result is satisfactory
13 Installing the sample / reagent racks and fridge rack
14 Verify the analyzer serial number for those units that have special
settings or specifications. Write down only if applicable
Actions of the product specialist
14 Install reagents
15 Enter the calibration values and control ranges
16 Perform the analyzer verification process. Follow the instructions in
chapter 7.2.6

Operator signature and date Customer signature and date

144
Preventive maintenance
record

Laboratory name:

Analyzer Model:

Serial number:

Name of the technical manager:

Instalation date:

Steps Technical service actions Date performed


1 Clean electronic boards and fans from dust
Check fluidic connections from the pump to the probe and the connections
2 of the washing station, Check the tightness of the fittings and that none of
them leaks liquid.
Check the seal of the dosing pump. Verify that there are no leaks and that
3
no bubbles are produced.
4 Clean the filters in the distilled water container
5 Clean the washing station
6 Disassemble and clean the probe. Check their status.

7 Check the arm (Check the wear of the belts and their tension)
8 Check probe shock detection and protection system
9 Check the condition of the heating channel
10 Check the separation between gear and pinion of the rotor
11 Clean filters, slit and photodiode
12 Check placement and detector of general cover and reaction cover
13 Check that the general cover is properly supported and does not
14 Carry out the tests with the service

Signature and date operator

Client's signature and date

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Service manual

AI. Technical specifications


PLEASE NOTE
The manufacturer accepts no liability for damage caused by incorrect use of the apparatus.

GENERAL SPECIFICATIONS
Automatic random access analyzer
Preparation cycle time 24 s (up to 150 prep/h)
Warm-up time 25 mins
Reading time for each preparation Every 24 s, up to 10 mins

REAGENTS AND SAMPLES TRAY


Positions for racks 4(2)*
Capacity of the sample racks 72(48)*
Maximum number of samples 72
Sample tubes ø13 mm, ø15 mm (max. height 100 mm)
Paediatric well ø13 mm paediatric well
Capacity of the reagent racks 10
Maximum number of reagents 30
Reagent bottles 20 ml and 50 ml

Possible configurations
Sample racks Reagent racks Number of samples Number of reagents
1 3(1)* 24 30
2 2(0)* 48 20
3** 1 72 10

*A15C(Reagent cooler version)


**A15 (Without reagent cooler version)

REAGENT COOLER*
Cooling capacity 10 ºC under ambient temperature (Ambient
temperature of de 25 ºC)
Power supply independent of analizer. Dedicated
power source and switch.
Open lid sensor and indicator power led.
*A15C(Reagent cooler version)

DISPENSING SYSTEM (NEEDLE)


Detachable tip
Vertical length 110 mm
Capacity level detection
Self-adjustment of position

NEEDLE THERMOSTATATION SYSTEM

146
Actuator Resistive elements
Control PID
Dispensation temperature 37 °C
Repeatability ± 0.5 °C

DISPENSING PUMP
Ceramic piston with PTFE-graphite seal
Piston diameter 8 mm
Dispensing volume 3 µL - 1250 µL
Programmable reagent volume 10 µL -440 µL
Programmable sample volume 3 µL - 40 µL

NEEDLE WASHING SYSTEM


System liquid consumption approx. 2.4 ml per preparation
System liquid container volume 3000 ml
Waste container volume 3000 ml
Capacitance waste and water level control

REACTIONS ROTOR AND READING


WELL ROTOR
Semi-disposable extractable methacrylate rotor
Number of wells 120
Accepted reaction volumes 180 µL - 800 µL
Light path length 6 mm

ROTOR THERMOSTATATION SYSTEM


Actuators 4 Peltier cells
Control PID
Working temperature 37 °C
Trueness ± 0.2 °C
Stability ± 0.1 °C

OPTICAL SYSTEM
Halogen lamp 6 V, 10 W
Wavelength selection with compensated
interferential filters
Detection system with silicon photodiode and 20-
bit AD integrator-converter
Measurement range from -0.05 A to 3.0 A
Reading speed 1.25 readings/s
Maximum number of filters 9
Base configuration of the filter wheel A15 340, 405, 505, 535, 560, 600, 635, 670 nm
Base configuration of the filter wheel Y15 340, 405, 420, 480, 520, 560, 600, 620, 635 nm
Wavelength precision ± 2 nm

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Service manual

Bandwidth 10 ± 2 nm
Digital resolution < 0.0001 A
Base line stability max. 0.004 A in 30 min, at 505 nm

MINIMUM COMPUTER REQUIREMENTS


Operating system Windows® 7 64 bits (x64)
Windows® 10 64 bits (x64)
CPU Equivalente a Intel Core i3 @3.10 GHz o superior
RAM memory 512 Mbytes
Hard disk 20 Gbytes
CD-ROM Yes
VGA Monitor Minimum resolution 640x480
Mouse Yes
USB Conector USB
The insulation level of the communications channel of the A15 analyzer is reinforced (the insulation of
the communications channel of the computer must also be reinforced)(1)
Reinforced insulation is that which ensures protection equal to or higher than double that provided by
(1)

the main insulation.


The main insulation is that whose failure could lead to a risk of electric shock (EN 61010-1).

POWER REQUIREMENTS
Input voltage 125 Vac - 230 Vac, ±10%, 50/60 Hz
Power 150 VA (200VA)*
Electrical installation category (overvoltage II
category)
The power point must be officially approved, earthed and the cable must have a minimum cross-
section of 1.5 mm2.
*A15C(Reagent cooler version)

ATMOSPHERIC CONDITIONS
Interior use
Height < 2500 m
Temperature 10°C - 35°C
Relative humidity < 75%
Contamination level 2

COMPLIANCE WITH DIRECTIVES


A15/A15C model:
Directive CE – IVD 98/79/CE

The manufacturer reserves the right to modify any technical specification without prior notice.

148
COMPLIANCE WITH DIRECTIVES
Y15/Y15C model:
Low voltage directive 2014/35/EU
Electromagnetic compatibility directive 2014/30/EU
A15/A15C/Y15/Y15C:
Directive on restriction to the use of certain 2011/65/EU
dangerous substances in electrical and electronic
equipment.

MAXIMUM SIZE OF ANALYZER


With the lid closed (Width, Depth and Height) 840 mm x 665 mm x 600 mm
With the lid open (Width, profu Depth and Height) 840 mm x 710 mm x 1050 mm
Weight 45 Kg

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Service manual

AII. Adjustment margins tables


Main voltage measurement points Positioning of the dispensing point
CIIM0015 Power supply board Dispensing rotor [90,120]
Fine rotor X [35,200]
TP1 – 6V [5.6 – 5.8] V
Positioning of rotor in optic
TP2 – 12V [11.7 – 11.9] V
Positioning [-15,0]
TP3 – 5V [4.9 – 5.2] V
Filter wheel positioning
Sp150 [23.5 – 24.5] V
Positioning [-5,5]
Rotor thermostatation
CIIM0026 Microprocessor board Set point temperature [36,37.5]
Test Des- Nominal V Range V Nominal Needle thermostatation
Point cription stress stress mode V Set point temperature [35,45]
mode standby Bottle level control sensitivity
Water empty [200,255]
Vref X
TP56 1.95 V [1.75 – 2.14] 640 mV Water full [46,230]
motor
Water calculated [115,240]
Vref Waste empty [200,255]
TP57 Pump 1.95 V [1.75 – 2.14] 640 mV Waste full [113,245]
motor Waste calculated [160,245]
Vref Level detection sensitivity
TP58 Filters 1.95 V [1.75 – 2.14] 1.48 V Paediatric rack [35,100]
motor 13/15mm tube sample rack [25,90]
Vref Reagent rack [5,45]
TP59 Rotor 1.60 V [1.44 – 1.76] 640 mV Integration times
motor F1 340 nm [180,420]
F2 405 nm [40,150]
Vref Z F3 505 nm [40,150]
TP60 2.35 V [2.11 – 2.58] 2.35 V
motor F4 535 nm [40,150]
Vref Y F5 560 nm [40,150]
TP61 2.35 V [2.11 – 2.58] 640 mV
motor F6 600 nm [40,150]
F7 635 nm [40,150]
F8 670 nm [50,150]
Main adjustment values of the analyzer
Number of counts
Tolerances
F1 340 nm [750000,960000]
Operating arm positioning
F2 405 nm [840000,940000]
X axis loss of steps
F3 505 nm [840000,940000]
Loss of steps [-3,3]
F8 670 nm [840000,940000]
Y axis loss of steps
Darkness counts
Loss of steps [-3,3]
F1 340 nm [3700,4800]
Z axis loss of steps
F2 405 nm [3700,4300]
Loss of steps [-3,3]
F3 505 nm [3700,4300]
Loss of steps rotor motor
F8 670 nm [3700,4300]
Loss of steps [-3,3]
SMF repeatability (Noise)
Loss of steps filter drum motor
Dev. Est. NC. F0 Covered ≤ 55
Loss of steps [-3,3]
Dev. Est. Abs. F1 340 nm ≤ 0.0004
Loss of steps pump motor
Dev. Est. Abs. F2 405 nm ≤ 0.0006
Loss of steps [-4,4]
Dev. Est. Abs. F3 505 nm ≤ 0.0004
XY position adjustment
Dev. Est. Abs. F8 670 nm ≤ 0.0007
X origin [10,125]
Stability at 505 nm
Y origin [240,290]
Dev. Est. Abs. F3 505 nm ≤ 0.0008
X washing station [330,450]
Max. NC [840000,940000]
Y washing station [70,120]
Min. NC [840000,940000]
X rotor [60,170]
Max NC / Min NC ≤ 1,006
Y rotor [1020,1060]
Repeatability MF (Repeatability)
Self-centering of needle
Dev. Est. Abs. F1 340 nm ≤ 0.0008
X Offset [-4,4]
Dev. Est. Abs. F2 405 nm ≤ 0.0006
Y Offset [-4,4]
Dev. Est. Abs. F3 505 nm ≤ 0.0005
Dev. Est. Abs. F4 535 nm ≤ 0.0005
150
Dev. Est. Abs. F5 560 nm ≤ 0.0005
Dev. Est. Abs. F6 600 nm ≤ 0.0005
Dev. Est. Abs. F7 635 nm ≤ 0.0005
Dev. Est. Abs. F8 670 nm ≤ 0.0005

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Service manual

AIII. List of consumables, accessories and spares


If any of the components of the analyzer deteriorate of if any of the perishable materials are required, always use
original BioSystems material. The following table shows lists of components that may be required. To purchase said
components, please contact your usual distributor and order each element using its corresponding code. This will
simplify work and minimise errors.

Accessories list
Code Representation Description
AC13188 User Program CD

AC17343 Stool A15 User Program CD

CA10455 European network cable

CA10456 American network cable

FI14226 USB Cable

AC10770 Pediatric Reaction Wells (1000)

AC11485 Reaction Rotor (10 units)

AC11486 Reaction rotor fixation screw

152
Accessories list
Code Representation Description
BO11493 50 mL bottle with stopper (10 units)

BO11494 20 mL bottle with stopper (10 units)

AC11500 Detachable tip

AC17342 A15 stool tip

BO11524 Concentrated System Liquid Bottle (1 L)

BO13416 Bottle of concentrated washing solution (100 ml)

FI11563 340nm filter assembly

FI11564 405nm filter assembly

FI13821 420nm filter assembly

FI15242 480nm filter assembly

FI11565 505nm filter assembly

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Service manual

Accessories list
Code Representation Description
FI13812 520nm filter assembly

FI11490 535nm filter assembly

FI11491 560nm filter assembly

FI10708 570nm filter assembly

FI16339 580nm filter assembly

FI11566 600nm filter assembly

FI13816 620nm filter assembly

FI11567 635nm filter assembly

FI11568 670nm filter assembly

AC16355 700nm filter assembly

FI16423 750nm filter assembly

FI15673 880nm filter assembly

FI11498 Filter assembly clogged

AC12446 Metal rod for tip cleaning (10)

AC12223 Allen key 2mm

154
Accessories list
Code Representation Description
FI11488 System Liquid Container Filters (2)

BO13189 System liquid container with cap

BO13191 Washing solution container with cap

BO13192 Waste container with cap and fitting

AC13369 Waste container plug and fitting

FU13194 Fuse set 2 A (F2L250V) (10)

LA10429 6V / 10W Halogen Lamp (5)

AC17355 Reaction rotor cover

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Service manual

Accessories list
Code Representation Description
AC13199 Height adjustable leg

AC13200 Filter drum cover

AC14549 20 / 50mL reagent rack (3)

AC14550 Tube sample rack (3)

AC14554 Tube adapter (80 units)

Spare parts
Code Represntations Description
CA13393 Base housing
AC17356

CA13395 Front housing


AC17352

156
Spare parts
Code Represntations Description
CA13379 Probe bottom housing
AC17350

CA13394 Upper housing


AC17349

CA13378 Probe top housing


AC17351

CA13397 Instrument cover


AC17354

CA13396 Spring protection cover


AC17353

ME13377 Hydropneumatic cylinder of the cover hinge

VA10355 Network connector

ZO10407 Fuse holder

AC17322 Refrigerator switch

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Service manual

Spare parts
Code Represntations Description
IN11557 Main switch

PC13384 Communications board

PC13386 Rotor interconnect board

PC13385 XYZ interface board

PC13383 Power supply board

AC17323 Refrigerator board

PC13381 Photometric system board

PC13387 Pump interconnection boarc

PC13380 Microprocessor board

158
Spare parts
Code Represntations Description
FO11562 photodetectors (5)

AC17324 Refrigerator power supply

TR13389 Main power supply

MO13358 Electronic box fan

AC16581 Waste pump

AC17315 Complete dosing pump

AC17316 Manifold

AC11527 Ceramic pump seal

159
Service manual

Spare parts
Code Represntations Description
AC17317 Manifold tube

TU13368 Waste PVC pipes

TU13366 Container tubes set

AC14307 Arm cables

AC13356 probe set with thermostatization

AC13360 Fitting Tighten probe

ME13355 Spring set

ME13352 Y axis belt


AC15521 Z axis guide pinion

AC13765 Z axis encoder

PC13382 Front indicator

160
Spare parts
Code Represntations Description
MO13363 Ceramic pump motor
AC16594

MO13372 Rotor motor

MO13376 Filter drum motor

MO13351 X axis motor

MO13353 Y axis motor

MO13354 Z axis motor

ZO13374 Lampholder

AC13370 Reaction rotor complete

AC15421 Rotor heating channel

161
Service manual

Spare parts
Code Represntations Description
AC17327 Rotor centering

AC13371 Rotor temperature probe

MO13357 Rotor fan

AC14497 Rotor Peltier Cell

AC13373 Rotor cover detector

AC13375 Filter drum body

AC17321 Refrigerator fan

AC17320 Refrigerator Peltiers

AC17319 Refrigerator temperature sensor

AC17318 Refrigerator Container + Lid

AC16065 Accessory boxes


AC16069 Packaging

162
List of necessary tools
Code Representation Description
Metric Allen wrench set.
Heat conductive silicone grease or the like
Welder
Screwdrivers or two 3mm diameter allen wrenches
AC13694 Torx wrench set
AC15212 Loctites set: 243, 641, 415
AC13935 Fluke thermometer
AC13079 ELESA NT1 mechanical grease (only for ceramic
pump)
AC11860 Temperature adjustment tool

AC15920 Adjusting tool for dispensing point on the rotor.

AIV. Software versions

Change in the versions of service program

Date version Change


04/04/06 3.0.1 First release version
20/07/06 3.0.2 Correction of errors
Improve the checking before load a new firmware
18/12/06 3.1.0 Modify the level sensitivity adjustment screen to incorporate the indepen-
dent adjustment by type of rack.
Added the help menu with the preventive maintenance guide.
13/12/07 3.2.0 Improve the fine zmax adjustment. Include a new menu to change the rotor
type.
22/01/09 4.0.0 Improve the adjustment position of the racks and reagents racks.
17/07/09 4.1 Modify the adjustment menu to include an option to select the type of
racks: metal rack or plastic racks.
Included a new menu to use the photometry tool.
06/04/17 4.2.1 Software needed for instruments with cooler.
26/9/17 4.2.2 Modification to adjust the new stool tube

163
Service manual

Change in the A15 versions of user program

Date version Changes


04 /04/06 3.2.1 First release version
20/07/063.2.2 New button in the tools menu, reset the historical base line
Fix the options of the initial and final wash. Delete the menu to choose the
parameter of initial and final wash. Add a maintenance guide in the help
menu.
14/11/06 3.3.0 Improve and optimitation of the execution times of the application. Correc-
ted the application errors that showed the message «not respond»
05/03/07 3.3.1 Korean language included
Change of some test adapters
Correction of low frequency errors
21/03/07 3.3.2 Added the Korean language. Correction of Run Time errors.
14/06/07 4.0.0 Added the Romanian and indonesian languages
Added the substrate depletion control function in kinetic test
Added the prozone control function in turbidimetric test
Added the correlation of result per test with other analysers
Added graphical representation of results
Change the reagent Blank use in calibration factor calculation
Added a new patient results report
Added a new document explaining the Remarks messages
17/07/09 4.1 New function of LIMS online communication.
New function of the calibration plot: when a concnetration value is out
of the plot it can repeat with a postdilution factor.
14/05/10 4.5 Improved the management of bireagent test with reading time of 600s
New option to share positions in the rack of reagents with different
test.
Displaying the kinetic curve of calibrators.
Add new test in samples with AutoNumber identifier.
1/10/10 4.5.2 Correction of Magnesium Xylidil test. Added new contamination pro-
gramation. Added new calculated test.
1/8/11 4.6.1 New test to HbA1C.
Change of the type name of the test from PLM to SEM and from CSF
to LIQ.
Shows the regression line and the regression coefficient in the test
with calibration curve and linear regression.
19/3/12 4.7 Possibility of positioning tubes and pediatric wells in the same rack.
New functionality of automatic calibration curve by dilluciones from a
single calibrator.
7/9/12 4.7.1 Bugs Fixed
29/1/15 4.8.2 New window for tests sorting.
Improvement in the searching method in historics window.
It can enter the number of replicates in the new sample window.
12/3/15 4.8.3 New tests added.
15/7/15 4.9.1 Improvement in prozone detection.
22/12/15 4.9.3 Fixed bugs
2/11/17 5.2 Software version for instruments with cooler.
It can perform continuous load of samples without pressing pause
button.
New alarm of subtrate consumption with the end point method
In predilution can select the diluent
New calculate test with external parameter
6/7/18 5.2.4 New methods
7/18/19 5.4 New option to auto-pause at the end of the work list.
164
Being able to create calculated techniques from calculated
Add a warning message at the end of the rotor advising you to remove
it from the equipment
Be able to select the order in which patients / samples are displayed
on the results screen
Be able to create calculated technique profiles
To save the results out in history
To be able to calculate the bichromatic differential and bichromatic
fixed time
Be able to perform absorbance techniques

Change in the versions of firmware


Date version Change
04/04/06 2.90 First release version
09/05/06 2.92 Improvements in the generation of the pattern of encoder
18/12/06 3.10 In order to avoid the splashes in the dispensation of the predilution, the
dispensation speed have been reduced.
The sensitivity adjustment have been split in 3 diferents adjustments, one
for each type of rack.
Correction of the bireagent with 10 minuts of reading time and with pro-
grammed contamination.
6/02/07 3.12 Increase the stabilization time of the commutation of 3 way electro-
valve.
07/03/07 3.14 Correction: when shut-down is made and next the warming-up without dis-
connecting the analyzer the termostatización of the probe does not activa-
te.
15/05/07 3.20 Added an autodiagnosis system for internal use.
29/10/07 3.24 Correction of the transition state from shutdown to sleeping. Improved the
swith-off of global-stress
Correction of initial washing when previously the cover was open and clo-
se.
16/04/08 3.28 Correction of the predilution manoeuvre when tube rack is used
22/01/09 3.50 Improve the adjustment position of the racks and reagents racks. New sen-
sibility maps of the improved racks
17/07/09 3.61 Include both types of sensibility maps: metal maps and plastic maps.
Correction about enter the serial number of the analyzer
Added a protection of the Shut-down process.
14/05/10 3.70 Improve in the predilution maneuver.
Improve in the bireagent maneuver with reading time of 600s
11/6/14 4.12 Improvement in the sample detection in particular cases.
9/11/15 5.10 A new sistem of rotor autocentering.
15/03/17 6.02 Firmware for instruments with cooler.
15/12/17 6.16 New Firmware to add the new tube type for stool
10/16/19 6.19 Expansion of the acceptance margins of the baseline for the 340nm

Compatibilities table
Usua. A15 4.7 4.8.3 4.9.1 4.9.3 5.2 5.4
firmware
3.70 x x x x
4.12 x x x x
5.10 x x x x
6.02 x x
6.16 x x
6.19 x x

It is advisable to always install the last existing version of firmware.


165
Service manual

Change in the versions of user program of Y15

Date version Change


4/07/09 4.0.7 Positioning the reagent in rack of samples.
Printing the calibration curve
16/03/09 4.0.9 Customizing the A15 program: change icons, change the name of
sample types: WINE, MOST, BEVE and WAT.
Including absorbance test and calculated test:
ICM=A420+A520+A620
Tint=A420/A620
Shade=A520/A620
03/09/09 4.2.0 Change of application name to Y15.
Change of repetition criterion of multicalibrador test with linear regres-
sion. In this version do not repeat until the limit of linearity.
14/05/10 4.4.0 Improved the management of bireagent test with reading time of 600s
New option to share positions in the rack of reagents with different
test.
Displaying the kinetic curve of calibrators.
Add new test in samples with AutoNumber identifier.
1/8/11 4.6.1 New tests.
Show the regression line and corretation coeficient in test with cali-
bration curve and lineal regression.
Possibility to delete point in test with calibration curve and linear re-
gression.
19/3/12 4.7 Possibility of positioning tubes and pediatric wells in the same rack.
New functionality of automatic calibration curve by dilluciones from a
single calibrator.
7/9/12 4.7.1 Bugs fixed
29/1/15 4.8.2 New window of sorting tests.
Improvement in the finding method in the historics window.
It can enter the number of replicates in the new sample window.
12/3/15 4.8.3 New tests added.
15/7/15 4.9.1 Improvement in prozone detection.
22/12/15 4.9.3 Bugs fixed
15/6/16 5.0 It can perform continuous load of samples without pressing pause
button.
2/11/17 5.2 Software version for instruments with cooler.
It can perform continuous load of samples without pressing pause
button.
New alarm of subtrate consumption with the end point method
In predilution can select the diluent
New calculate test with external parameter
6/7/18 5.2.4 New methods
7/18/19 5.4 New option to auto-pause at the end of the work list.
Being able to create calculated techniques from calculated
Add a warning message at the end of the rotor advising you to remove
it from the equipment
Be able to select the order in which patients / samples are displayed
on the results screen
Be able to create calculated technique profiles
To save the results out in history
To be able to calculate the bichromatic differential and bichromatic

166
fixed time
Be able to perform absorbance techniques

Compatibilities table Y15


Useer Y15 4.6.1 4.7 4.8.3 4.9.1 5.0 5.2 5.4
firmware
3.70 x x x x x x
4.12 x x x x x x
5.10 x x x x x x
6.02 x
6.16 x x
6.19 x x

It is advisable to always install the last existing version of firmware.

167
Service manual

AV. Refurbish instructions

This chapter explains the instructions for the refurbish and control of the instruments traded as rental or loan, or
second hand.

Terms

• Life: Analyzers have the functionality for life as long as they keep maintenance conditions specified by the ma-
nufacturer and the use of original spare parts. Note that the manufacturer is obliged to provide spare parts up to
5 years after discontinuing the analyzer.

• Number of times can be refurbished: You can refurbish as many times as necessary, provided the overhaul
following the instructions described in this section and the use of original spare parts.

• Accessories used in refurbished devices: Any accessories used in refurbished analyzer are provided by the
manufacturer. Any fungible remaining from the last use such as rotors, extra reagent bottles, cleaning solution,
fluid system, and so on, will discarded.

• Staff: The refurbishment will be done by personnel authorized by Biosystems. It will normally be the distributor
service staff, or someone has received the appropriate training.

Instructions

Cleaning and disinfecting

• Users carrying out disinfection processes must wear gloves and protective apparel. All consumable materials
(reaction rotor, reagent bottles, sample tubes) will be treated as potentially infectious waste.
• Check whether there are any reaction rotors in their compartments or reagent bottles in the refrigerator. If there
are, dispose of them.
• Empty the high contamination waste tank and washing solution tank.
• Wash the inside of the equipment using a damp cloth and neutral soap. If there are splashes, wash them with
alcohol.
• Follow the applicable national guidelines for disposing of waste that is considered potentially infectious.

Components to change

• Change the tip. (AC11500) Use the utility change the tip of the service program. Discard the tip. Treat as potentially
infectious. To manipulate the tip wear gloves to protect the user.
• Changing the inner tubes of Teflon (AC13365 and TU13366)
• Changing the lamp and he lamp socket. (LA13195 and ZO13374) Use the utility lamp replacement of the service
program.
• Changing the pump seal ceramic (AC13361)
• Update firmware and software

Verification and adjustment process

Carry out the following checks, consult the service manual (chapter 3) to carry out the verifications. If a verification
does not fit within the values, adjust again

• Verification of XYZ arm positions


• Verification of readings rotor positions and filter wheel
• Verification of the sensibility level detection with the different bottles and tubes
• Verification of the thermostatization of the tip and rotor
• Photometry test
• Integration times
• Number of accounts
• Dark accounts
• Repeatability without moving filter drum

168
• Stability at 505 nm
• Repeatability by moving filters

Final functional verification

To carry out the functional verification of the instrument, follow the detailed instructions in chapter 7.2.6 and fill in the
excel sheet with the verification data and then print it out for registration.
Ask the technical service department for the Excel file.

Ending

• Place an indelible label to the refurbished analyzer. The label contains the following information (check with the
national legislation of each country):
1. The name and address of the company responsible for implementing and refurbishing
2. The date of last revision
3. The number of refurbish performed
4. Indication that it is a renewed equipment
5. Lifetime after refurbishing.

• Add a new box of accessories (AC16065).


• Use original packaging. Previously check it the status and if it is deteriorated then replace by a new one.
• Send completed record to the Bioystems service technician (pdf) sat@biosystems.es

AVI. Removal of instrument from use for repair or


disposal of waste
In the event of the instrument needs to removal for repair or disposal, follow the next instructions.

• Wear gloves and protection for the user who will perform the disinfection process. Treat disposables (rotors,
reagent bottles, sample tubes) as potentially infectious.

• Check if there is any reaction rotor in the housing and reagent bottles. If so, discard them.

• Empty waste containers and liquid system.

• Clean the outside of the computer with a damp cloth and mild soap. In case of splash, locally wipe with alcohol.

• In case of changing or disposing of the tip, use the tip change utility of the service program. Treat it as potentially
infectious.

• Follow the current national regulations for disposal for potentially infectious waste.

169
RECORD OF REFURBISH PROCESS

Company name: Acceptance of refurbished


Serial number
Refurbished OK
Refurbish date: Ok / No Ok
Available for sale

SPARE CHANGE PROCESS


Signature:

1. Spare change
TIp change Ok / No Ok
Prepared by:
Teflon tubing change Ok / No Ok
Lamp change Ok / No Ok
Pump seal change Ok / No Ok
Update firmware and
Ok / No Ok
software

VERIFICATION / ADJUSTMENT PROCESS

Verification of XYZ arm


Ok / No Ok
positions
Verification of readings ro-
Ok / No Ok
tor positions and filter drum
Verification of the sensibi-
lity level detection with the Ok / No Ok
different bottles and tubes
Verification of the thermos- Ok / No Ok
tatization of the tip and rotor
Photometry test Ok / No Ok
Integration times Ok / No Ok
Number of accounts Ok / No Ok
Dark accounts Ok / No Ok
Repeatability without
Ok / No Ok
moving filter drum
Stability at 505 nm Ok / No Ok
Repeatability by mo-
Ok / No Ok
ving filters

FUNCTIONAL VERIFICATION

Verification according to
Ok / No Ok
section 7.2.6
Print and save the results
Ok / No Ok
of the Excel sheet

TERMINATION

Finish
Place label of refurbished Ok / No Ok
equipment
Add full box of accesories Ok / No Ok
Check packaging Ok / No Ok

Page 1/1 Rev 2 Operative date: 4/5/20

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