AIA360 - ServiceTrainingGuide - REV12 PDF

AIA360_ServiceTrainingGuide_REV12
TOSOH AUTOMATED
IMMUNOLOGY ANALYSER
AIA-360
Service Training Guide

 Mechanical and Electronic Adjustments
 Theoretical Explanations Clog Detection & Detector
 Software
 AIA Test Cup Explanation and Analytical Troubleshooting
 Error Troubleshooting
 General Verification AIA360 and Functional Tests
 Installation & Maintenance Procedures
Software version 1.36S/1.36U
TOSOH EUROPE N.V. Marc Leupe  1

Contents list:
1. TRAINING PROGRAM 6
2. LEARNING OBJECTIVES 7
3. AIA GENERAL MEASUREMENT SEQUENCE 8
4. AIA-360 CARACTERISTICS 9
5. AIA-360 SYSTEM CONFIGURATION 10
6. AIA-360 DISASSEMBLY 11
7. AIA-360 ASSEMBLY 12
8. AIA-360 ELECTRONICS 13
8.1. POWER SUPPLY CONFIGURATION 13
8.2. MAIN BOARD 14
8.3. SENS BOARD 15
8.4. DRIVER BOARD 15
8.5. DETECTOR BOARD 16
8.6. EKI BOARD 16
8.7. LCD TOUCH PANEL BOARD 16
8.8. THERMAL PRINTER 16
8.9. KEY BOARD 16
9. ADJUSTING INSTRUMENT 17
9.1. GENERAL MECHANICAL ADJUSTMENTS 17
9.1.1. Turntable adjustment 17
9.1.2. Wash probe adjustment 19
9.1.3. Seal breaker adjustment 20
9.1.4. Sample height adjustment 22
9.1.5. Cup reader position adjustment 22
9.1.6. BCR position adjustment 23
9.2. SAMPLE NOZZLE MECHANICAL ADJUSTMENT 24
9.2.1. Diluent suction position 24
9.2.2. Washing position 25
9.2.3. Drain port position 25
9.2.4. Cup dispensing position 25
9.2.5. Sample suction position for sample cup 26
9.2.6. Sample suction position for 75mm tube 27
9.3. ADJUSTMENTS CHECK 27
9.4. MANUAL ADJUSTMENTS 27
9.5. ELECTRONIC ADJUSTMENT 28
9.5.1. Fluid level sensing 28
9.5.1.1. Definition sampling and level sensing 28
9.5.1.2. Why level sensing is so important 28

9.5.1.3. What method is used 29

9.5.1.4. Theoretical background 29
9.5.1.5. Procedure to adjust Level sensing 30
9.5.1.6. Procedure to verify Level sensing 30
9.5.1.7. Macro to verify Death Volume and Level Sensing 30
9.5.1.8. Procedure to verify Level sensing and to calibrate sampling volume 31
9.5.1.9. Procedure to collect Level sensing data 32
9.5.2. Temperature adjustment 33
9.5.3. Clog Detection 34
9.5.4. Detector 35
9.5.4.1. Theory 38
9.5.4.2. Detector adjustment 42
9.5.4.3. Detector calibration 43
9.5.4.4. Daily Maintenance 45
9.5.4.5. During assaying 46
9.5.4.6. Detector Verification and Troubleshooting 46
10. SYSTEM SOFTWARE 47
10.1. SOFTWARE UPDATE PROCEDURE 47
10.2. PARAMETER BACKUP 47
10.3. PARAMETER INITIALISATION 48
10.4. PARAMETER ANALYSIS 48
10.5. SOFTWARE TRANSLATIONS 49
11. ANALYTICAL TROUBLESHOOTING 50
11.1. DEFINITION AND EXPLANATION 50
11.2. POSSIBLE CAUSES AND SOLUTIONS 50
11.3. IMMUNOLOGY REACTION IN AIA 53
11.3.1. Tosoh AIA cup 53
11.3.2. One step Sandwich Assay 54
11.3.3. Competitive Binding Assay 55
11.3.4. AIA Principle and Rate Calculation 56
11.4. METHOD OF ELIMINATION 57
11.5. METHOD OF INDIVIDUAL AND COMBINED TESTS 59
11.5.1. Method of Individual Tests 59
11.5.2. Method of Combined Tests 59
11.5.3. Procedure to follow to troubleshoot flyers or instability in low rates 60
12. ERROR TROUBLESHOOTING 61
12.1. MOST FREQUENT ERRORS 61
12.2. BF PROBE PURGE FAILURE ERROR 2015 61
12.3. BF PROBE SUCTION FAILURE ERROR 2016 63
12.4. SUBSTRATE PURGE FAILURE ERROR 2017 63
12.5. LEAK SENSOR S701 DETECTED ERROR 3021 64
12.6. LEAK SENSOR S702 DETECTED ERROR 3022 64

12.7. SAMPLE LEVEL FAILURE ERROR 2010 64
12.8. AIR DETECTED SAMPLE ERROR 2011 65
12.9. SAMPLE LEVEL DETECTION ERROR 2013 66
12.10. SAMPLE SHORTAGE DETECTED 2014 67
12.11. WASH SYRINGE HOME SENSOR ERROR 4043 68
12.12. WASH SYRINGE HOME OVERRUN ERROR 4045 68
12.13. WASH SYRINGE HOME NOT FOUND ERROR 4044 68
12.14. TURN TABLE HOME NOT FOUND ERROR 4002 69
12.15. TURN TABLE HOME SENSOR ERROR 4001 69
12.16. TURN TABLE HOME OVERRUN ERROR 4003 69
12.17. TURN TABLE SLIP 4004 69
12.18. DL FLAG 70
12.19. HB FLAG 71
13. GENERAL VERIFICATION 72
13.1. VISUAL INSPECTION WITHOUT COVERS REMOVED 72
13.1.1. Turntable Inspection 72
13.1.2. Movement Turntable with power off 72
13.1.3. Drain Tubing Inspection 72
13.1.4. Waste, Diluent and Wash tubing connections 73
13.1.5. Check Piercing Quality 73
13.1.6. Check amount of Substrate in Testcup after analyzing 74
13.2. BASIC TESTS WITHOUT COVERS REMOVED 75
13.2.1. Perform 3,4 and 5 75
13.2.2. Perform 2: Substrate BG measurement 75
13.2.3. Perform 8: Detector substrate light measurement 75
13.2.4. Daily Maintenance 76
13.3. EXAM MENU TESTS 77
13.3.1. Sampling A to test the Sampling Volume 77
13.3.2. Wash Dip Test 77
13.3.3. Suction Washer Test 77
13.3.4. Drip Substrate Test 77
13.4. VISUAL INSPECTION WITH COVERS REMOVED 77
13.4.1. Inspect wash probe 77
13.4.2. Inspect Incubator cover for dirt 79
13.4.3. Inspect syringes for dirt at piston fixing plate 79
13.4.4. Inspect Sampling Probe Condition 79
13.4.5. Check for other abnormal dirt caused by leakage 80
13.5. BASIC TESTS WITH COVERS REMOVED 80
13.5.1. Wash sampler Nozzle, Diluent replacement 80
13.5.2. BF Prime with Hitachi cup 81

13.5.3. Inspection other sample probe positions 82
13.5.4. Run a test and verify all positions, functions and movements 82
13.6. RUN SAMPLES WITH ALL COVERS REFITTED 82
14. MAINTENANCE 83
14.1. CLEANING 83
14.2. REPLACEMENTS 84
14.3. MECHANICAL MOVEMENTS AND LUBRIFICATION 85
14.4. ADJUSTMENTS 85
14.5. DECONTAMINATION AND LIQUID FEED TEST 85
14.6. PRECISION TEST 86
14.7. ADDITIONAL MAINTENANCE 86
15. UPGRADES AND TECHNICAL BULLETINS 87
16. INSTALLATION 88
17. ISAP AND TOSOHCATALOG DEMO 89
18. EVALUATION AND EXAM 89
APP1. ACTUATORS AND SENSORS PER MODULE 90
APP2. FLOW DIAGRAM 91
APP3. TUBING LIST 92
APP4. ELECTRONIC INTERCONNECTION DIAGRAM 93
APP5. PARAMETER LIST 94
APP6. MOTOR CURRENTS 97
APP7. TOSOH MAINTENANCE 98
APP8. TOSOH INSTALLATION PROTOCOL 99

1. TRAINING PROGRAM:
 AIA-360 MEASUREMENT PRINCIPLE EXPLANATION
 AIA-360 CARACTERISTICS
 AIA-360 SYSTEM CONFIGURATION
 AIA-360 DISASSEMBLY/ASSEMBLY
 AIA-360 ELECTRONICS
 AIA-360 ADJUSTMENTS
 GENERAL ADJUSTMENTS
 SAMPLE NOZZLE ADJUSTMENT
 FLUID LEVEL SENSING ADJUST
 TEMPERATURE ADJUSTMENT
 CLOG DETECTION ADJUSTMENT
 DETECTOR ADJUSTMENT
 SYSTEM SOFTWARE
 AIA-360 ANALYTICAL TROUBLESHOOTING
 AIA-360 ERROR TROUBLESHOOTING
 AIA-360 GENERAL VERRIFICATION
 AIA-360 MAINTENANCE
 AIA-360 UPGRADES AND TECHNICAL BULLETINS
 AIA-360 INSTALLATION
 DEMO TOSOHCATALOG AND ISAP DVD
 TRAINING EVALUATION AND EXAM

2. LEARNING OBJECTIVES:
Preface: This manual is made for training purposes and can be used for
troubleshooting, maintenance, installation and upgrades. It consists out of 17
modules of practical and theoretical explanations. At the conclusion of this
training, the participant will be able to ….
 Understand the fluorescent measurement principle in immunology
 Assemble and disassemble an AIA-360 instrument
 Install, adjust and maintain an AIA-360 instrument
 Solve mechanical and electronic problems
 Solve analytical problems

3. AIA MEASUREMENT SEQUENCE:

4. AIA360 CARACTERISTICS:
 No tips are used for sampling
 Sampling with a metal probe
 Level sensing by capacitive differentiation and air detection
 Linear sample volume Clog detection: K1,K2
 No automatic dilutions and pretreatments
 Integrated sample and reagent carousel, no cup transfer arm
 Dichromatic detector with LED light source (same as on all AIA

instruments)

5. AIA360 SYSTEM CONFIGURATION:

 Remove ALL panels from the AIA 360 instrument.
 Location of the different modules: incubator, wash probe, syringes,

sample nozzle, and functional explanation: Each module has
actuators, valves and sensors (see App 1).
 Explanation Signal diagram (see App 2:flow diagram):
Waste circuit with waste pump LP401 connected to the overflow basin through
valve SV204 with overflow sensor and to the wash probe through valve SV402 for
wash aspiration during B/F separation.
Diluent circuit with diluent pump LP201 through valve SV202 connected to the
diluent port.
Wash solution circuit with wash solution pump LP202 to clean sample probe.
Sample syringe drive PM201 is responsible for sample pickup and dispensing. BF
syringe drive responsible for wash solution dispensing to the wash probe during
B/F separation.
Substrate circuit with substrate syringe driver PM501 for substrate dispensing.
 Location different electronic boards:
Power supply Board ADO-PWR-V2

Main Board ADO-MAIN-V2
Sens Board ADO-SENS-V3
Driver Board ADO-DRV-V2
DET Board (like AIA1800)
EKI Board (like AIA600II)

6. AIA360 DISASSEMBLY:
The following procedure shows a way to disassemble the main parts to have
access to the incubator, in case cleaning needs to be performed during
maintenance or in case parts from the incubator needs to be replaced. A
second method will also be explained.
PROCEDURE:
 Mark the turntable when S101 is OFF (this will make the adjustments
easier after reassembly)
 Remove sampling needle
 Remove the detector
 Remove the detector support
 Remove COMPLETE Wash probe unit (3 screws) and explain
importance
 Remove COMPLETE substrate unit (2 screws)
 Remove the CCD camera.
 Remove Seal breaker together with support (4 screws)
 Remove incubator cover and wheel clamping plate
 Remove the instrument frame fixed to the chassis
 Remove home sensor incubator.
 Remove the turning table, and explain how to remove the sample
holders.

7. AIA360 ASSEMBLY:
This module is a practical session for trainees. Trainees will be asked to
assemble the instrument following the reverse sequence explained in
previous module, only leaving the panels removed! After assembly the
instrument needs to be started up in the test mode: Press ‘MENU’ button on
the key path while switching on the main power and wait until test mode
appears on the screen.
PROCEDURE:
 Leave the printer uninstalled as this will allow you to adjust the wash
probe positions and detector center position.
 The incubator cover can also be left off for adjustment purposes.
 Do not install the detector yet, only the bracket, as you will have to adjust
the detector position.
 Do not tighten the screws from the periphery components around the
turntable, as they have to be adjusted later

8. ELECTRONICS:
This module shows an overview of the different PCB’s in the instrument and
their functions. The most important test points, LED‘s and POT meters are
explained. The general electronic diagram (see App 4) is important to
understand the power supply distribution and the connectivity between the
different PCB’s. This diagram is indispensable during troubleshooting
procedures to help you locate and repair electronic and mechanical errors.
8.1. POWER SUPPLY CONFIGURATION:

 Inlet with noise filter.
 NFB circuit protector 3A (No Fuse breaker)
 Switching power supply, input range 85-265V AC (47-63 Hz), output 24V DC,
max 240W
 Power supply board ADO-PWR-V2 containing six DC-DC converters ,
converting 24V DC into 5V, 12V and +/-15V (used for detector ) (see general
diagram for the power supply distribution)
PWR-V2 CHECKPOINTS:
FUSES A TP V LED V FUNCTION
FB1 1.6 1 +5 1 +5 LCD
FB2 5.0 2 +5 2 +5 Main PCB/Printerinterfaceboard
FB3 5.0 3 +24 3 +24 Input 24V/main fuse
Valve/motor/printerhead/Fan1/Fan2
4 GND 4 +24
5 +15 5 +15 Main PCB for DET

6 -15 6 -15 Main PCB for DET
7 GND 7 +15 Sens PCB
8 +15 8 -15 Sens PCB
9 -15
10 +12 Camera (via Main board)
11 +5

8.2. MAIN BOARD:

 The main board performs control of the overall system and has two CPU’s on
board, main and slave CPU. Including flash memory, SRAM main memory,
serial transmission controller (COM port), parallel IO and lithium battery to
backup SRAM.
 The main CPU controls all other boards and regulates directly the detector unit,
display unit, printer and external transmission.
 The slave CPU controls the SENS board and the DRV board.
ADO-MAIN-V2 NORMAL STATUS: LED 3 AND LED 7 FLASHING

LED LED STATUS FUNCTION
1 FLASHING FIFO receiving
2 FLASHING FIFO sending
3 FLASHING NORMAL
4 ON + 5 POWER SUPPLY
5 ON/FLASH Turntable temp. control
6 ON/FLASH Substrate heater temp
7 FLASHING NORMAL
8 ON/FLASH Wash solution heater temp
Remark: LED 5, 6 and 8 start flashing when temperature is reached!
ADO-MAIN-V2 ABNORMAL STATUS: LED 3 AND LED 7 ON

MAIN SLAVE
FUNCTION LED1 LED2 FUNCTION LED6 LED8 LED5
Program error ○ ● Program error ○ ● ●
Illegal interrupt ● ○ Memory error ● ○ ●
Memory error ○ ○ Illegal interrupt ○ ○ ●
FIFO ini error ● ● ○
FIFO send error ○ ● ○
ADO-MAIN-V2 SWITCHES
SWITCHES FUNCTION
SW1 Main CPU reset
SW2 Slave CPU reset
SW3 Main CPU mode setting
SW4 Slave CPU mode setting

8.3. SENS BOARD:

 The SENS board is connected to different types of sensors: temperature
sensors, mech on/off sensors, capacitive sensors, optical sensors, pressure
sensor.
 The board includes the analog circuits to convert the different signals into
correct analogue signals for the main board:
 I/V conversion for the level sense frequency signal.
 Amplification and offset (VR1 and VR2) of voltage from the pressure sensor
for clog detection.
 Temperature to voltage conversion (VR3,VR4 and VR5)
 Manage B/F probe overflow sensors (no VR’s)
ADO-SENS CHECKPOINTS
F A FUNCTION TP TYPE FUNCTION LED TYPE FUNCTION
FB1 1.6 +15V PROT 1 AGND Analog ground 1 EKI Brightness ~ Voltage
FB2 2.0 +5V PROT 2 2 S102 Turntable home

position
3 EKIMEN Fluid level detection 3 S207 Water tank overflow
4 Clogging detection 4 S402 B/F probe overflow
5 +15V Analog circuits 5 +15V Analog circuit
6 Vcc 6 +5V Vcc
7 TMP1 Turntable temp 7 S701 Leakage sensor table
8 TMP2 Wash solution temp 8 S702 Leakage sensor wash
9 TMP3 Substrate heater temp 9 S208 Waste tank full
10 AGND Analog ground 10 S405 Wash solution tank ok
11 -15V Analog circuit 11 S404 Diluent tank ok
8.4. DRIVER BOARD:

 The DRV board is transforming signals and commands from the main board
into powerful signals to drive the step motors, temperature heaters, solenoids
and fluid pumps.
 VR1-VR10 are used to adjust the pulse motor current levels, increment is
clockwise.(see electronic adjustments 7.1.5.1 in service manual)

ADO-DRV-V2R0
JUM POS SETTING FUNCT TP FUNCT LED FUNCT
1-10 1-2 Open all Microstep 1 GND 1 +5V Vcc and digital
3-4 Closed Half step 2 +5V 2 +24V For drive applications

5-6 Closed Full step 3 +24V 3 +24V For control applications
4 1-Vref 4 SV201 Sol. Valve for nozzle
washing
5 2-Vref 5 SV202 Sol. Valve for diluent
6 3-Vref 6 SV402 Sol. Valve for B/F
7 4-Vref 7 SV204 Sol. Valve for drain
8 5-Vref 8 SV401 Sol. Valve for diluent
9 6-Vref 9 SPARE
10 7-Vref 10 SV501 Sol. Valve for substrate
11 8-Vref
12 9-Vref
13 10-Vref
14 GND
15 GND
16 GND
8.5. DETECTOR BOARD:

 Consists out of 2 V/F converters and amplifiers for the reference and the
sample signal using +/- 15V. The ref and sample signal are connected to the
main board F/V converters.
 The light source is an LED powered by a 5 V supply
8.6. EKI BOARD:
 The board is used to detect fluid levels using the change in capacitance.
 The board has an oscillator and produces a frequency related to the
capacitance of the sample probe and this analog signal is connected to the
sens board directly.
8.7. LCD TOUCH PANEL BOARD
8.8. THERMAL PRINTER
8.9. KEY BOARD

9. ADJUSTING INSTRUMENT:
In this module the participants will practically execute all the mechanical
adjustments, the mechanical adjustments for the AIA360 are easy and can
be performed without any tools or calculations. Electronic adjustments for
level sensing, clog detection and detector are explained in following modules
in order to better understand the adjustments and measurement principles
that are used in all AIA instruments.
9.1. GENERAL MECHANICAL ADJUSTMENTS
9.1.1. Turntable adjustment:
Remarks:
 Be aware if you remove the turntable or turntable motor all positions for sample
needle, seal breaker, will need to be readjusted as the pitch sensor S101
position has been altered. Therefore mark the Turntable before removing it!
 The Turntable reagent cup position has to be adjusted by the sensor S101 and
is the reference or detector reading position. The detector reading position
alignment with the turntable can also be done by moving the detector bracket
manually; this avoids changing the pitch sensor S101.
 Ones the detector position is adjusted by the pitch sensor all other positions for
sample needle, seal breaker, cup reader, substrate, etc. will have to be
adjusted or checked manually towards the cup hole positions on the turntable.
PROCEDURE TO ADJUST DETECTOR POSITION AFTER DISASSEMBLY:

Remarks: The turntable movement is controlled by 2 sensors:
 S101 Pitch sensor, activated each time the turntable moves one position further
and is used for fine adjusting the turntable positions
 S102 Home sensor, to locate pos 1 on the turntable
Both flag and flag slit must be at the sensor

S101, S102 positions. Sensor
S102
 Select MENU, SPECIAL MENU, MECH CHECK and select FREE PULSE
MOTOR.
 Remove the detector (do not disconnect the cable)
 Refit the Turntable corresponding to the marks you placed on the turntable and
the chassis while S101 was OFF. If no marks available then refit the Turntable
and turn it manually until a cup holder is positioned to the Nord position.
 Verify the sensor S101 and when the LED is ON loosen the encoder disk
screws and adjust the slit position by holding the turntable fixed until LED is
OFF. Now fix the screws.
 Place a target cup in a position on the turntable and move the turntable until the
target cup is positioned under the detector reading position and the S101 LED
is OFF!
 Fine adjust the detector position with the detector bracket screws until the
target cup is perfectly under the detector reading position. Fix the detector
bracket fixing screws.
Remark: Now the reference is set and the encoder disk position cannot be
changed in further adjustments!
PROCEDURE TO ADJUST TURNTABLE HOME POSITION:

Remark: When TURNTABLE SET HOME is performed the turntable will turn until
sensor S102 sensor is ON; at the same time S101 sensor is verified and need to
be OFF.
 Turn the turntable until the S102 flag triggers the sensor, this can be also done
by monitoring LED2 on the sens board.
 Determine the sector on the encoder disk during which the LED2 is on. The
sector’s angle is around 90°. A perfect adjustment is when the encoder slit is in
the middle of the sector. Adjust sensor S102 until you reach acceptable
condition: S101 off and S102 on.
 Perform TURNTABLE SET HOME to check the condition: S101= OFF,
S102=ON. FREE PULSE MOTOR and re-verify the sector LED2=ON and the
slit position.
Remark: Make sure the S102 flag on the Turntable does not touch the sensor
physically during the Turntable rotation.

9.1.2. Wash probe adjustment X, Y and Z:

PROCEDURE:
 Set home turntable and place a target cup in the Turntable pos 1. Press
‘SAMPLE FEED’ 12 times until the target cup is located under the wash probe.
 Select MECH CHECK and press FREE PULSE, now lower the wash probe by
hand so that the tip or white nozzle slightly contacts the target cup seal
 If off center, loosen the screws fixing the sample probe see the green circles in
the picture to make sure the probe is located exactly in the middle of the cup.
The adjustment can also be done in the turntable drain position (more
accurate!)

 If unable to adjust by moving the wash probe, you have to readjust the
turntable pitch sensor by repeating 8.1.1. And adjust the detector position
again!!
 Select MECH Check, WASHER, SET HOME and TURNTABLE, SET HOME.
Replace the target cup with a pierced STD cup and press ‘SAMPLE FEED’ 12
times until the target cup is located under the wash probe.
 Select MECH CHECK and press FREE PULSE, now lower the wash probe by
hand so that the tip or white nozzle slightly contacts the bottom of the cup (the
gap should be 0!). See also T116
The gap
 Select PARAMETER SET, WASHER TESTCUP BOTTOM, the wash probe

motor will be excited and the fine adjustment menu is displayed.
 Fine adjust Z-axis by pressing – or + and press OK. The wash probe returns
to home position and the new pulses are displayed. Press OK again to accept
the new adjustment.
9.1.3. Seal breaker adjustment X, Y and Z:
PROCEDURE:
Remark: Before adjustment makes sure the seal breaker is vertical and the driving
belt is tight.
 Turntable set home. Place a target STD cup in pos 1 of the Turntable. Press
‘SAMPLE FEED’ 3 times until the STD cup is located under the seal breaker.
 Remove the camera to get better view on the seal breaker for adjustment
 Verify visually if the seal breaker is positioned straight above the STD cup.
This can be done by using tool 940057. Or it can be done by lowering the seal
breaker by hand, first select FREE PULSE, until it reaches the seal of the cup,
verify the piercing mark. Adjust by loosening the 4 screws (see green circles)
securing the seal breaker support and adjust.
Remark: If too difficult for adjustment you can use the other screws for adjustment
but be aware to verify the belt tension and smooth movement afterwards.

Screws to set
the seal breaker Other screws
vertical that can be
used for
adjustment
Thicker ring
 Replace the target cup with a pierced STD cup.

 Verify fine adjustment Z-axis by selecting MECH CHECK and press PARAM
SET. The Seal breaker motor will be deactivated. Lower by hand the seal
breaker until it enters the center of the cup and the gap between the thicker ring
and edge of the cup is around 2 mm.
 Select SEALBREAK LIMIT, the seal breaker motor will be excited and the fine
adjustment menu is displayed.
 Fine adjust Z-axis by pressing – or + and press OK. The seal breaker returns
to home position and the new pulses are displayed. Press OK again to accept
the new adjustment.
 Turn the Turntable to remove the pierced cup and check the piercing quality!
Repeat adjustment X, Y if not ok.

9.1.4. Sample height adjustment:

PROCEDURE:
 Load the Turntable with 12 sample cups and 12 dedicated primary tubes.
Position 25 remains empty.
 Go to SPECIAL MENU, EXAM MENU and select 3 SAMPLE SENSOR 25,
press OK. The carousel rotates and the tubes are detected by two sensors,
S103= UP and S104= DN.
 After the rotation the display shows reading information:
 READ OK COUNT must be 24

 READ NG COUNT must be 1 for position 25
 COUNT Primary tubes must be >300
 COUNT sample cup must be >400
Example printout:
 If above conditions are not for filled (see above example), loosen the two
screws securing the bracket of the sample sensors and move the unit closer to
the turntable. Repeat this procedure to check again.
9.1.5. Cup reader position adjustment:

PROCEDURE:
 Select MECH CHECK menu and select ALL SET HOME.
 Load the Turntable with 1 STD cups in positions 1
 Press ‘SAMPLE FEED’ twice, this moves the STD cup below the camera.
 Select MECH CHECK, select TURN TABLE and press OK. Select TESTCUP
READ and press OK.
 Adjust the camera position so that the cup is at the center position (adjust in
opposite direction). The 3 fixing screws can be used to move the camera in the
X and Y direction.
 Also check the light area and adjust with light fixing screws if necessary.
Unit fixing screws
Light fix screws
Camera fix screws
 Please check the reading quality from the picture info:

 X is within 215-265
 Y is within 215-265
 Light value >150
 Dark value <100
 Check value code and lot
 If above condition are not for filled, readjust position of the camera, clean the
lens or check camera focus and led’s.
 If above conditions ok, load the complete Turntable with 24 STD cups. Select
SPECIAL MENU, select EXAM MENU and select TEST CUP READ25. Press
OK. At the end of the test you will get the reading result.
 READ OK COUNT should be 24
9.1.6. BCR Position adjustment:

PROCEDURE:
 Select MECH CHECK, select ALL SET HOME.
 Load some primary tubes with barcode label in the carousel, by press the
‘SAMPLE FEED’ button 2 times to get the first tube in front of the barcode
reader.

 Select MECH CHECK, select TURN TABLE and press OK. Now select
BARCODE READ and when OK is pushed the barcode reader will read the
label. If not change the angle of the barcode reader by unscrewing the
barcode reader while pushing the OK button until the reader reads correctly.
 Also here you can use a functional test in the examination menu: BCR READ
25. Fill up the turntable with 24 reagent test cups and execute the test.
9.2. SAMPLE NOZZLE MECHANICAL ADJUSTMENTS:
Remark: Check the needle condition before adjustment!
Overflow
Position
Drain
Position
Diluent
Position
Wash
needle
Position
9.2.1. Diluent suction position:

PROCEDURE:
 Select MECH CHECK and press PARAM SET. The step motor will be
deactivated automatically.
 Move the sampling arm by hand to adjust the THETA-axis, R-axis and Z-axis
(+/-3mm up from the bottom) to the diluent port
 Select SAMPLER DILUENT BOTTOM and press OK. The sampling arm motor
is excited and fine adjustment screen is displayed.
 Fine adjust THETA-axis, R-axis and Z-axis by pressing – or + and press each
time OK. In the end the sampling arm returns to home position and the new
pulses are displayed. Press OK again to accept the new adjustment.

9.2.2. Washing position:

PROCEDURE:
 Move the sampling arm by hand to adjust the THETA-axis, R-axis and Z-axis
(a little up from the bottom,+/- 0,5 cm) to the sampler wash position.
 Select SAMPLER WASH BOTTOM and press OK. The sampling arm motor is
excited and fine adjustment screen is displayed.
Remark:
 When the needle is moving up verify if the needle is in the middle of washing
hole at the moment it leaves the washing position. If not ok it might be the
needle is not correctly vertically aligned with the washing port. This can cause
needle crash the next time the needle is moving down in the washing port.
 To prevent this you can adjust the needle at the entrance point of the wash
port to make sure it will enter the wash port correctly in the middle and then set
the Z parameter manually (see 9.4 manual adjustments)
9.2.3. Drain port position:

PROCEDURE:
 Move the sampling arm by hand to adjust the THETA-axis, R-axis (Z-axis is
same as on diluent port and does not need to be set) to the drain port.
 Select SAMPLER DRAIN POSITION and press OK. The sampling arm motor
is excited and fine adjustment screen is displayed.
 Fine adjust THETA-axis, R-axis by pressing – or + and press each time OK. In
the end the sampling arm returns to home position and the new pulses are
displayed. Press OK again to accept the new adjustment.
9.2.4. Reagent cup dispense position:

PROCEDURE:
 Select MECH CHECK , select ALL SET HOME.
 Place a pierced STD cup at cup holder position 1
 Press ‘SAMPLE FEED’ 5 times to move the STD cup at the cup dispense
position.

This position is
not used
 Select PARAM SET and move the sampling arm by hand to adjust the THETA-
axis and R-axis visually to the center of the STD cup and position the Z-axis
(around 2mm above the cup bottom)
 Select SAMPLER TESTCUP BOTTOM and press OK. The sampler motors are
excited and the fine adjustment screen is displayed.
9.2.5. Sample suction position for sample cup:

PROCEDURE:
 Select MECH CHECK, select ALL SET HOME.
 Place a sample cup at sample cup holder position 1
 Press SAMPLE FEED 8 times (see position in picture) or put the cup directly in
the Nord position.
 Select PARAM SET and move the sampling arm by hand to adjust the
THETA-axis, R-axis visually to the center of the cup and position the Z-axis a
little up from the bottom.
 Select SAMPLER SAMPLECUP BOTTOM and press OK.The sampler motors

are excited and the fine adjustment screen is displayed.
pulses are displayed.
9.2.6. Sample suction position for 75mm tube:

PROCEDURE:
 Select MECH CHECK , select ALL SET HOME.
 Place a sample tube 75mm at sample cup holder position 1
 Press SAMPLE FEED 8 times.
 Select PARAM SET and move the sampling arm by hand to adjust the Z-axis a
little up from the bottom (Theta en R-axis are the same for Sample Cup and
don’t need to be adjusted)
 Select SAMPLER TUBE BOTTOM and press OK. The sampler motors are
excited and the fine adjustment screen is displayed.
 Press OK to accept the new adjustment.
9.3. ADJUSTMENTS CHECK:

 Select MECH CHECK, select SAMPLER and press OK.
 Select COMPOUND ACTION and press OK
 Select one of the positions you want to verify: MOVE command.
 If the position needs readjustment repeat the above procedures or follow the
manual fine parameter position adjustments in following chapter.
9.4. MANUAL ADJUSTMENTS:

Remark:
As everything is performed manually, be careful not to enter the wrong parameters
as this can damage some parts. It is advised to use the procedures in 8.1 and 8.2
to adjust the instrument.

Example:
 SAMPLER, THETA-AXIS, DILUENT POSITION and press ok. Here you can
use SET HOME and record the value.
 Position the cursor to ABS PULSE and press OK. In the input screen
displayed enter the pulse value and press OK.
 Press EXIT to return to MECH CHECK
 Write down the new pulses and input the new pulses: MECH CHECK ,
PARAM MODIFY, select MODIFY
9.5. ELECTRONIC ADJUSTMENT:

9.5.1. Fluid level sensing
9.5.1.1. Definition sampling and level sensing
 Sampling is the activity were a sample probe or tip is moving down into a
sample tube or sample cup to aspirate a precise amount of sample volume
between 10µL and 100µL to perform a immunoassay test.
 Level sensing is the activity were the sample probe or tip stops moving down
in the sample tube or sample cup when reaching the surface of the liquid
(serum, plasma).
Remark: After reaching the surface the sample probe will move a little bit down in
the liquid, just enough to take the specified volume that is required (10µL-100µL)
9.5.1.2. Why level sensing is so important

 Knowing Remaining Volume:
The tube bottom and sample cup bottom are defined as Zmaxtube and
Zmaxcup (mm). A correct level sensing will define Zliq and the remaining
volume can be measured as follows:
Vtube = Stube x (Zliq-Zmaxtube)
Vcup = Scup x (Zliq-Zmaxcup)
The remaining volume is important to know if there is still enough sample to
aspirate for the next test.
 Uptake correct volume:
When the sample probe enters too deep in the liquid there is a risk that sample
will be collected at the outside of the sample probe and will be added to the
aspirated volume. This will cause high result concentrations for small volume
uptake tests (FT4)
 Avoid Risk of sample probe obstructions:
Some primary tubes have thick material at bottom of the tube or fibrins, after
centrifugation all impurities are centrifuged to the bottom of the tube. Uptake of
fibrins can obstruct the sample probe and influence the uptake quantify.
Sampling at the surface is recommended!

9.5.1.3. What Method is used:

Two methods are used in AIA instruments:
 Change in Air Pressure: During the down movement the sample probe blows
air and the pressure is monitored. When reaching the liquid surface the
pressure is rising. A predefined pressure threshold will trigger the Zaxis motor
to stop. (used in AIA-21)
Advantage: Plastic disposable tips and probes can be used, less influence
from noise.
Disadvantage: Inaccurate due to obstructions in the probe, air leaks, slow
 Change in Capacity: During the down movement the change in capacity of the
sample probe is measured by an electronic circuit. When reaching the liquid the
capacity will change in such a way that it will reach the threshold value and
trigger the Zaxis motor to stop. This method is used in all other AIA
instruments
Advantage: fast detection, accurate
Disadvantage: Influence to noise, use of expensive disposable conductive tips
9.5.1.4. Theoretical background:

Level sensing is performed by the EKI board oscillator:
A change in capacity between the sample probe in open air and liquid produces a
change in frequency. This frequency is converted in an AD value on the CPU
board with a range from 0 to 1000.
INI : AD value of Nozzle in open air: around 600-900 (see T108)
When the sample probe is reaching the liquid surface the AD value will decrease.
Liquid is reached (motor stops) when the following equation is valid:
-9
∑ AD(i) / 9 - AD(i) > TH → surface is detected
i= 0
Calculation of the threshold value TH:
THliq = RATIO * (INI-OFS) / 100
As the threshold value TH is different for each instrument due to gain and
sensitivity the calibration is done by determination of the capacity of the human
body or the hand touch AD value or OFS value.
RATIO = Depends on level sensing in tube or sample cup (Rtube=5, Rcup=3)
INI = Value starting the level sensing (open air)
OFS = Hand touch value AD, around 300

Surface detection signal

690
r ef r ence
im pr ov e
680
670
660 Liquid surface

AD Value
650
640
Noise because of
vibration
630
620
0 2000 4000 6000 8000 10000 12000 14000
Z a xis pulses （P L S )
9.5.1.5. PROCEDURE TO ADJUST HAND TOUCH AD:

 Select SPECIAL MENU , MECH CHECK and select SAMPLER, press OK
 Select PRIME DILUENT and press OK to replace washer inside the nozzle.
 Select SPECIAL MENU , MECH CHECK and press PARAM SET
 Select HAND CONTACT AD, while holding the nozzle by hand press OK.
Press OK to set the new value in the parameter list. Value around 300-450.
9.5.1.6. PROCEDURE TO VERIFY LEVEL SENSING:

 Execute a level sensing test. Place a sample cup with 500 µL serum in
position one of the turntable. Select MECH CHECK, SAMPLER, COMPOUND
ACTION and select LIQUID DTETCT (Sample1). The sample nozzle will
detect the level and will give you the measured volume (depends on tube
bottom position!). This value should be around 300 till 400. If not OK adjust the
bottom sample cup again (see 9.2.5 and 9.2.6). Do the same for a tube. The
result depends also on the shape of the cup or tube
 To test the AD value in real time, select MECH CHECK, SAMPLER, AD,
Liquid AD. The value in free air is between 600 to 950
 To verify the ratios, select MECH CHECK, PARAMETER MODIFY, LIQ LEVEL
and press MODIFY. You will get a list with the Hand touch AD value and the
ratios for different level sensing’s.
9.5.1.7. MACRO TO VERIFY VOLUME AND LEVEL SENSING:

 The real volume is determined by the LevelCalibCup and LevelCalipTube
parameters (see App 5). SPECIAL MENU, SYSTEM SPEC, LEVEL CALIB
PLS CUP; TUBE. Default =0, do not change these values!
 Confirm the carrousel is in the home position and place a sample cup with
200µL and sample tube with 500µL in positions 1 and 3.
 Press MENU, press SPECIAL MENU, press EXAMINATION then select
LIQUID SENSE and press OK
 The instrument performs 5 level sensing’s on the sample cup and the sample
tube. The calculated volume and surface detection AD’s are printed out. An
excellent test to verify the level sensing stability and precision!
 The AD values or volumes should be within following ranges:
120 < Scup (µL) < 250
400 < Tube (µL) < 600
CV (volumes) < 4%
 If not verify the sample nozzle Z position for sample cup and tube and make
sure the nozzle reaches the bottom(see 9.2.5 and 9.2.6). Example:
9.5.1.8. PROCEDURE TO VERIFY LEVEL SENSING ,SAMPLE PICKUP AND

DISPENSING :
 Level sensing, sample pickup and dispensing can be monitored by performing
this test. This test is frequently used to locate ‘AIR DETECTED’ errors
2011and to calculate the volume calibration parameter.
 Place 4 pierced STD cups in position 1 to 4 and 4 pierced STD cups in
position 5 till 8. Then place 2 sample cups with 2mL diluent in positions 1 and
5.
 Perform EXAM MENU, SAMPLING A
 Level sensing and 100µL suction and dispensing will be performed 4 times for
STD cups 1 till 4 and 200µL for STD cups 5 till 8.
 Remove the main cover and verify visually all movements and level sensing
sequence.
Remark: The volume in the test cups can be measured by weight and CV’s can be
calculated to obtain sampling accuracy. The ‘suction A’ parameter is calculated
as follows (default=1).
Suction A = 100/ Measured weight (for the 4 first cups)

9.5.1.9. PROCEDURE TO COLLECT LEVEL SENSING DATA:

 AD level sensing information can be obtained by connecting the AIA360 with
cross wired RS232 connection to a PC. Use the HyperTerminal
communication program and check the settings.
 Make sure the instrument is in the test mode. Go to MECH CHECK, ALL SET
HOME and press ok. Press SYSTEM SPEC on the SPECIAL MENU screen
and select DEBUG MODE and press modify key. Change 0 to 2. In RS232
settings select ‘Transparent mode’!
 Go to MECH CHECK and move cursor to SAMPLER and press ok. Select
COMPOUND ACTION and press OK. Select LEVEL TEST(LIQ2-POS1) and
press OK. Level sensing AD values are now sent to the PC every step down
movement. This data can be saved can be exported to excel to generate a
graph:
310
At start the blue 305
and pink line are
unstable as the 300
未対応（異常時）
EKI board is still 295
vibrating. Finally 対応後（正常時）
when going 290
deeper the pink 285
line is ok. Blue line
showing 280
0 1000 2000 3000 4000
excessive noise
 Excessive noise can now be monitored by analyzing the data. It can be

caused by vibrating nozzle, tension of the belt, slide rail, bad connections and
the EKI board damper.
EKI board damper:

eliminating
mechanical vibrations
during radial
movement sample
nozzle

9.5.2. Temperature adjustment:

PROCEDURE:
 Check the target temperatures in HEATER PARAMETER list (see App 5) or
select MECH CHECK , PARAMETER MODIFY:
 Turntable(HT01) SET DEG: 38, ERR-RNG: 2
 Wash heater(HT401) SET DEG: 39, ERR-RNG:2
 Substrate heater(HT501) SET DEG:39, ERR-RNG:2
 Use a temperature meter and verify the temperatures for the different
modules. Adjust if needed on the SENS board (Increase is anticlockwise) the
LED’s are on the main board:
 VR3 (LED5) for the turntable, increments in CCW
 VR4 (LED8) for the wash solution temperature
 VR5 (LED6) for the substrate temperature
 Verify the temperature control by selecting MECH CHECK and select
HEATER.
Remark: The temperatures can also be adjusted by setting the SET DEG
parameter. Go to SPECIAL MENU, MECH CHECK, PRAM MODIFY. Enter the
correction value to 1.SET DEG at HT401,HT501,HT101 until temperature is within
the standard range. When changing the value at SET DEG restart the instrument
and check the temperature again.
REF +
PID REGULATOR HEATER
SENSOR

9.5.3. Clog detection:
PRINCIPLE AND THEORY:
Remark: To detect specimen clogging, the analyzer is monitoring the inner

pressure of the specimen syringe during sample pickup. If the air flow in the
specimen arm is disturbed by dirt or dust , specimen clog error may occur. In this
case wash inner side nozzle with by 70 % ethanol.
If the clog error occurs also for a normal sample then perform clog adjustment.
Following methods are used:
1. Pressure difference during start and end of suction (∆Psuction) is measured.

∆Psuction is verified with a reference pressure. The reference pressures are
determined for all different suction volumes. The linear reference pressure
curve is determined by a suction with a blocked tip attached and the slope of
the curve is calculated and multiplied by the blocked suction ratio (0.1 for
AIA360)
2. Pressure in the sampling tip is monitored and measured 9 times during the
suction of specimen. The measured pressures are compared with a calculated
reference curve. If difference between both curves is too high following below
formula, UC flag will be triggered:
9
∑ (Pi –Piref)² >= TH
i=1

The Piref values are determined by different human specimens taking into account
the instrument variations. TH is defined for each specific volume.
Reference pressures are determined for 4,10,20,25,75,100 µL and saved in the
instrument parameter list.
This method is not used in the AIA360.
Following chart shows the AD pressures for a serum compared with the ref curve
and this for a specific volume:
This algoritme is also used in AIA900, AIA1800 and AIA2000
Method 1:
Determination of the reference pressures is done by clogging a sample tip and

performing a suction of 10µL or 49pulses.
A= Pressure without blocked tool (atmospheric pressure)

B= Pressure when the probe is blocked with a rubber tool (a slight pressure in the
probe will be induced)
Now the syringe is moving 49 pulses corresponding to 10µL and the curve is
extrapolated in the picture until the volume of 100µL. This is the Blocked Sample
Probe Curve.
C= ∆PrefBlock10µL = pressure after uptake of 10µL with a blocked sample probe.

How to determine the slope of the Blocked Sample Probe curve:
S= C-B/10
Taking the reference as the Blocked Sample Probe Curve would not trigger any
clog. Therefore we multiply the slope with the Blocked Suction Ratio
blocked Suction Rate = 0,1 (for AIA360)
Or S’= (C-B/10) x 0.1
The slope is now calculated in function of suction pulses:
suction pulse = volume(µL)/capacity resolution

capacity resolution= 0,204 for AIA360
K1= ((C-B)/10 ) x 1024 x 0,204 x 0.1
Or the reference curve is:
∆P = (K1/1024) * suction pulse + K2

K2= (B-A) x 0.1~ 0
If ∆Psuction > (K1/1024) * suction pulse + K2 a clog will be produced.
CLOGGING ADJUSTMENT:
 On the SENS board turn VR1 (gain) and VR2 (offset) full clockwise.
 Turn VR1 10 turns in CCW direction and check the following: MECH CHECK,
SAMPLER, 10AD, 2CLOG AD.
 An AD value for pressure is displayed and needs to be adjusted to 450-550
using VR2, this is the offset adjustment (value A). Vacuum in the sample
needle will produce a lower AD value.
 Select EXAM MENU and select IMPASS SENS
 When READY is displayed attach a clogging tool (this can be a rubber or Para
film) to the sample nozzle and press OK. Values A,B en C are measured 3
times to verify the stability of the measurements and to verify if the needle was
clogged correctly (check stability of the C values)
 A = 450-550 (A= pressure in open air)

 A-B >=-350 (B= pressure when probe is blocked)
 C-B = -200 till -80 (C= pressure after suction of 10µL)

 The new parameter CLOG LEVEL1 is calculated and a report is printed out.
The new CLOG1 saved in the parameter list after COMPLETE is displayed.
CLOG1 or K1 = (B-C)/10 * 0.1 * 1024 * 0.204

CLOG2 = 0 (default value)
CLOG3 = 20 (µL, it is the upper limit volume when AIA-360 stops sampling
when detect clog)
Example:
Good: Not good:

9.5.4. Detector:
9.5.4.1. Theory:
The detector is capable of measuring two fluorescent signals: Sample signal
(450nm-480nm) and reference signal (575nm-625nm). Both signals are amplified
and offset adjusted by VR1 (offset R), VR2 (gain R), VR3 (offset S) and VR4 (gain
S), the signals are sent after V/F conversions to the main board were the signals
are processed:
Detector without reference measurement
Detector with measurement of reference signal

After incubation and washing the reagent cup contains a certain amount of alkaline
phosphates (ALP) in relation to the concentration of the parameter we have to
measure. Just after incubation period a substrate solution 4MUP is added to the
reagent cup. ALP is an enzyme that is able to transform 4MUP into 4MU. The
speed of the production of 4MU is called the RATE and this will be the parameter
used in relation to the concentration of the test we have to measure. Because 4MU
appears to be fluorescent, we are able to measure the signal and calculate the
RATE!
C ↑ ALP ↑ S ↑ 4MU ↑
The substrate contains a second component DA used as reference and is used to
check the substrate quality (aging), lamp intensity and quantity during assaying
and to compensate lamp intensity and substrate quantity while measuring results
as results are calculated relatively towards the substrate reference background:
S/R
Conclusion: The signal S measured by the detector is a measure for 4MU and the
reference R measured by the detector is a measure for DA.
So after the incubation and wash, 200µL substrate is dispensed in the reagent cup
and the S and R are measured. In the AIA360 S and R are measured 80 times,
each measurement takes 1,2 sec. The complete measurement cycles takes
around 100 sec. (see also aia360.dat file / results/ view Ref, Sam to view all the
measurement data). The following values are measured for 80 points, So and Ro
are the background values measured at daily maintenance in an empty STD cup.
As the So,Ro values vary in time due to detector aging we measure the S and R
relatively to So and Ro:
Si-So/Ri-Ro

Interpolation of these values is producing a parabolic function:

S-So/R-Ro = at² + bt + c = Ffl(t)
As we will use the speed of transformation of 4MU or RATE as the parameter
related to the concentration of a test we need to find the relationship between the
4MU and S. This is what we call detector calibration.
Below curve is an example how to determine the relation between S and 4MU by
using the detector standardization solution or 3 known 4MU concentrations.
During detector calibration the following function is determined:
4MU = Fcal(S-SO/R-RO) See graph detector calibration:
During the fluorescent measurement the following function is obtained:

Ffl(t) = (S-SO/R-RO)
And now we can obtain 4MU in function of the time:
4MU = Fcal(Ffl(t))
Now we can calculate the speed of the transformation of 4MU in function of the
time what we also define as RATE:
RATE = d4MU/dt = 4MU’
Finally we obtained following graph:

Overview of the SoffL,RoffL and S80000nM, R0nM values to adjust the detector:

9.5.4.2. Detector adjustment:

Adjustment is important to get the detector aligned in the linear amplification range
for the practical 4MU concentrations during assaying. It is done by using an empty
STD cup, a STD cup filled with 200µL 0nM 4MU and 200µL 80000nM 4MU. These
solutions can be ordered: 015969. The set values indicated here are based on
the third generation detector with orange label. The detector can be ordered:
021109. See previous page for the values for other type of detectors and AIA
instruments!
Refer to the document in AIA_generalservice:’detector adjustment values’ to find
values for yellow and red label.
When replacing the detector, only the ‘detector calibration’ should be
performed. The adjustment of the detector should be performed only when
the detector showed values out of range.
PROCEDURE OFFSET ADJUSTMENT:

 Remove the VR adjusting cover on top of the detector.
 Turn both VR2 (R) and VR4 (S) gain potentiometers completely in CW
direction.
 Place the empty and pierced STD cup at position 1 in the turntable. Press
SAMPLE FEED until the cup moves under the detector.
 Reinstall the top cover to prevent light influence when measuring the offset
values.
 Select SPECIAL MENU , MAINTE and select DETECTOR (dark) then press
OK, lamp source LED remains OFF, and displays the following values:
LampOffSam and LampOffRef
 Use VR1 (R) and VR3 (S) to adjust the offset:
SoffL = RoffL = 75 (0 – 150)
 Press EXIT
REF SIDE GAIN ADJUSTMENT:

 Place the cup with 200µL 0nM 4MU in position 1 in the Turntable. Press
SAMPLE FEED until the cup moves under the detector.
 Select SPECIAL MENU , MAINTE and select DETECTOR (light) then press
OK, this turns the lamp on and displays the following values: SonM and RonM
 Use VR2 (R) to adjust the reference value to :
RonM = 33000 (26000-40000)
 Press EXIT
 Turn the Turntable and remove the cup.

SAMPLE SIDE GAIN ADJUSTMENT:

 Place the cup with 200µL 80000nM 4MU in position 1 in the Turntable. Press
SAMPLE FEED until the cup moves under the detector
 Select SPECIAL MENU , MAINTE and select DETECTOR (light) then press
OK, this turns the lamp on and displays the following values: S80000nM and
R80000nM
 Use VR4 (S) to adjust the sample value to:
S80000nM = 390000 (312000-469000)
 Press EXIT
 Turn the Turntable and remove the cup.
 The detector is now adjusted in an acceptable linear range for the amplifiers R
and S.
9.5.4.3. Detector calibration:

During detector calibration the detector measures the offset values for an empty
cup and cup with substrate, these values are saved in the detector parameter list
(see App5). With 3 known concentrations of 4MU we will determine the relation
4MU and S-Soini/ R-Roini as explained in the detector theory session.
FITTING EQUATION:
3 known 4MU concentrations: STD1= 0 ,STD2= 10000 and STD3= 80000 are used
to determine the graph:
S-Soini/R-Roini = Fcal (4MU)

The following function can be used to fit the curve:
1/ (Y-c) = a/x + b were x= 4MU and y= S-Soini/ R-Roini
a,b and c are determined by using 3 known 4MU concentrations: STD1= 0 ,STD2=
10000 and STD3= 80000.
PROCESS AND VALUES OBTAINED:
 Dark measurement: the detector turns off the lamp and measurement is done
within an empty STD cup. The following values are obtained and saved as INI
values in the detector parameter list:
SoffL = LampOffSample
RoffL = LampOffRef
These values represent the background signal from the detector itself (noise).
 One empty STD cup is set and measured under the detector with lamp on and
the following values are obtained and saved as INI values in the detector
parameter list:
Soini = BackgroundIniSam
Roini = BackgroundIniRef

 One STD cup is filled with 200µL substrate and measured under the detector
with lamp on and the following values are obtained and saved as INI values in
the detector parameter list:
Ssubini = substrateIniSam (not used)
Rsubini = substrateIniRef
These values are not used for the detector calibration but are used to calculate
the IniRatio which is a value indicating the detector condition, this parameter is
also saved as INI value in the detector parameter list:
IniRatio= Rsubini-RoffL/ Roini-RoffL (for AIA360 this value is +/- 100)
 Each 4MU solution 1,2 and 3 is dispensed 3 times in a STD cup, 9 STD cups
are needed in total and for each solution the mean and CV is calculated:
S1,R1: S2,R2: S3,R3
These values are used to calculate the detector calibration equation or
coefficients a, b and c.
The CV‘s are calculated and checked with the consistency parameters in the
system parameters:
CalibChk0nM ,10000nM,80000nM
PROCEDURE: Order 015969 STD solutions

 Carry out daily check in order to fill up reagents, use fresh substrate
 Prepare the detector test solutions and 10 STD cups
 Fill up 3 sample cups with each 1000µL: 0nM,10000nM and 80000nM
calibrator solutions.
 Press SPECIAL MENU and press EXAM MENU, then select 20 DETECTOR
CALIBRATION and press OK
 Put 0nM sample cup in position 2, 10000nM sample cup in position 5 and
80000nM in position 8
 Place 10 STD cups in positions 1 to 10
 Press START and check the conditions:
LampOffRef = Dark R < 400
LampOffSam=Dark S < 400
STD1-1,2,3 Ref between 26000-40000
STD3-1,2,3 Sample between 312000-469000
If not within conditions a new detector adjustment might be necessary. Verify
also the precision between the measurements of each STD solution (CV’s) to
check on the sampling precision and suspect the standardization solutions
quality.

9.5.4.4. Daily Maintenance:

During the daily maintenance the detector, substrate dispensing and quality is
checked.
PROCESS AND VALUES OBTAINED:
 One STD cup is placed under the detector with lamp on and the following
parameters are obtained:
Sodaily = BackgroundSam
Rodaily = BackgroundRef
 Then substrate is dispensed and placed under the detector. The following
values are obtained:
S1 =Ssub = SubstrateSam
R1 =Rsub = SubstrateRef
EVALUATION AND CHECKING VALUES:

 Lamp intensity check: the following condition is checked during the daily
maintenance:
LampChk > Rodaily- RoffL/Roini- RoffL
Default value LampChk = 0.5, the BackgroundRef can be maximum 50%
lower than the BackgroundIniRef. If condition fails an LL error will be
produced.
Remark: The RoffL and Rodaily vary relatively large with temperature fluctuations
of the detector and can cause false LL errors as above equation becomes
unstable. This problem is solved in AIA2000, AIA900 were the detector is
temperature regulated. See also T020
 Detector condition and substrate replacement check: the following condition is
checked:
SubRepChk1 < Rsubdaily/ RsubIni < SubRepChk2
The value obtained during detector calibration is compared with the value
obtained during the daily maintenance. Default value for SubRepChk1 = 0.5
and SubRepChk2 = 1.5 allowing 50% difference with the initial value. If
condition fails an error ‘substrate replacement check NOK’ will be displayed.
 Substrate background signal: Using the calculated detector calibration curve ,
the 4MU value is determined of the dispensed substrate during daily
maintenance:
4MUSub = Fcal ‾¹ (Ssub-So / Rsub-Ro)
4MUSub < 4MUCheck
Default value for 4MUCheck = 1500. If the condition fails the daily maintenance
will fail and HB will be produced.

9.5.4.5. During assaying:

During assaying certain conditions in relation to the detector, sample and substrate
are checked:
 4MU is calculated at time t1 (near 100sec ):
4MUt1 = F4MU(t1) < 90000
If condition fails the detector is saturated and the rate and concentration
values cannot be calculated and flag DO is set
 Substrate background signal is calculated each time the substrate is
dispensed just after the incubation time at to
4MUt0 < 1500
If condition fails the rate and concentration will be calculated but a flag HB flag
is set.
 If during the rate calculation a denominator becomes 0 in one of the formulas,
a CE flag can be produced.
 The substrate reference value Rsubanal is determined during each assaying .
The following condition is checked:
SubIniRefChk > Rsubanal/ Rsubini. Default value SubIniRefChk = 0, 5. If
this condition fails successively 3 times the flag DL is set. The reference
during assaying is compared with the reference that was measured during
detector calibration!
9.5.4.6. Detector Verification and troubleshooting

 S0 and R0 stability can be verified in an empty STD cup: MECH CHECK,
SELECT 8, DETECTOR. Option is to setup instrument in Debug mode and
connect a PC. Then the data can be imported in excel and stability can be
verified.
 Verification of S and R values obtained during analyzing can be viewed in the
aia360.dat viewer and can be very usefull to determine reading stability.
 In exam menu select DETECTOR CALIBRATION, select INFO. Verify the
values.

10. SYSTEM SOFTWARE:

10.1. SOFTWARE UPDATE PROCEDURE:
New software versions are published on the ISAP. Copy the 4 files onto a new
smart media 32Mbyte or on an USB stick depending on the Main board type.
Software includes the following files:
 Cu_main.mot/Touchpanel 3309 bit maps
 Installation.mot/Installation 277
 M_appl.mot /Main 1920 (includes text)
 S_appl.mot/Slave 261
The new software version in smart media format can also be ordered by part nr:
021139 but no guarantee that it will contain the latest version!
PROCEDURE FOR UPDATING:

 Perform a backup on the Smart Media or USB stick first. Select MENU,
MAINTE, BACKUP
 Turn off the power and while pressing the PAPER FEED button, turn on the
power again.
 Read the TB for details and eventual system parameter updates. Verify the
ISAP/GeneralService/SoftUpdateProc for general remarks about software
updates.
 Copy the software from the ISAP onto the SM card or USB stick that was
delivered with the instrument. Or if the SM card is lost order a new one:
021139. Any kind of USB stick can be used.
 Insert the SM card or USB stick and select the program to update.
 After program update, check the software version.
 Turn on the power.
10.2. PARAMETER BACKUP:
WHAT?
It is possible to backup all data to the smart media card (results, testfiles,
parameters, system spec, detector, error list) and view it on a PC. A list of all
parameters can be seen in App 5.
WHEN?
 Exchange the main board, parameters can be restored and
 instrument does not need recalibration

 Exchange the instrument, to restore test files and results.

 Recommended when upgrading the software
 To analyze errors
HOW TO BACKUP?
 Turn on system power while pressing MENU to enable the test mode and go
to MENU , select SPECIAL MENU
 Select EXAM MENU , insert the SM card or USB stick and select 25 DATA
BACKUP , or DATA TESTFILE backup and press OK
 After backup the file aia-360.dat or aia-360.testfile is created.
HOW TO RESTORE?
 Insert the SM card or USB stick and select 26 DATA RESTORE in the EXAM
MENU , press OK
 After checking info, press OK again and select the items to restore. You can
separately restore the information you want , like detector, test files,…After
restoring , reboot the instrument
10.3. PARAMETER INITIALISATION:
In the EXAM MENU 19-24 different data can be erased:

19 PROGRAM ERASE
20 RESULT INIT
21 TESTFILE INIT
22 PARAMETER INIT
23 ERROR LIST INIT
24 DAILY CHECK LIST INIT
10.4. PARAMETER ANALYSIS:
PROCEDURE:
 Open the application ISAP/GeneralServiceDoc/AIA360 Support tools

Setup.exe.
 AIA360 backup data and AIA360 Resource editor (only used for translation
purposes, see later) will be installed on your desktop.
 Start up the AIA360 backup data program and open the aia-360.dat on the SM
card or USB stick by selecting ‘FILE’ and ‘OPEN’.
 All the contents of the different folders can be viewed but not changed!
10.5. SOFTWARE TRANSLATIONS:
PROCEDURE:
 Two files supplied on the ISAP DVD in the folder software need to be
translated:
Message.c (text file)
Touchpanel.bmp (bitmap file)
 Translation of the text file can be done with the AIA360ResourceEditornew
which is also available on the ISAP. Start up this program and open the
message.c file, in the left column you will see all text messages in English, the
translator has to fill in all lines in the right column, save the file and sent it to
Tosoh headquarters service department
 Translation of the bit map file can be done with paint pro. Be aware not to alter
the size of the file. Save the file and sent it back to Tosoh headquarters
service department.
 Within reasonable time you will receive an e-mail with the compiled beta
version.
 This beta version needs to be tested within the country with the evaluation
procedure.

11. ANALYTICALTROUBLESHOOTING:
11.1. DEFINITION AND EXPLANATION:
Analytical problems are defined as problems reported by the customer related to

the outcome of the results, no mechanical error was reported by the instrument
and no visual failure was noticed. Mostly it can be observed by the following
abnormalities:
 Poor reproducibility of results
 Controls out of range
 Abnormal values in concentration or rates
 Intermittent abnormal results: flyers, false positive/negative
11.2. POSSIBLE CAUSES AND SOLUTIONS:
These problems are for sure the most difficult to solve or to locate. They can be
instrument, reagent, operator and environment related. Logic thinking, analyzing
and using the method of elimination will enable you to find the problem or
combination of problems. It is therefore indispensable to understand the meaning
of immunology and the reactions that take place in the reagent cup to be able to
interpret the results. This understanding will allow the engineer to distinguish
between instrument or reagent problem. If the problem is instrument related,
further analysis of the results will help to locate your defective part or to locate
external influences like temperature or contamination.
Possible causes Instrument:

 Inaccurate mechanical adjustment
 Inaccurate electronically adjustment: Temperature, clog detection,etc
 Software bug
 Contaminated wash, diluent or substrate lines.
 Substrate, wash and diluent dispensing problem.
 External leaking seals of syringes, leaking connectors
 Internal leaking valves.
 Obstructions: pinched tubing, sample nozzle, wash nozzle, blocked valves
 Vacuum Pump pressure instabilities causing bad suction

Possible causes Reagents:

 Substrate quality: expired, too high S1 (causing HB), too low R1 (see daily
maintenance and 4MU value)
 Contaminated H2O in laboratory for making wash and diluent
 Reported manufacture problems for calibrators, controls or testcup.
 Damaged reagents during transport: Temperature
Possible causes Environment:

 Temperature
 Humidity too high
 Dust or sand
 Physical vibrations: centrifuges, traffic
 EMI (ElectroMagneticInterferance): Mobile phones, MRI, Radiology
 Grounding
 Unstable power supply
 Insects, Rats, Mouse’s
Possible causes Operator:

 Using wrong concentration wash and diluent solutions
 Wrong preservation Tosoh control material (need to be frozen at day 1 in
eppendorf cups)
 Using expired reagents: calibrators, test cups, pretreatments
 Not complying with stability of calibrators (see IFU’s)
 Working with wrong test file parameters (units, factors, sample volume,..)
 Not performing daily maintenance (every 24 hours ones)
 Not checking wash, diluent and substrate quantities before performing daily
maintenance and during analyzing.
 Not cleaning or replacing wash nozzle (every 4000 tests)
 Not using original Hitachi cups (other Zcupmax, does not fit completely in holders)
 Using primary tubes with caps (this will crash the tubes)
 Insufficient centrifugation (causing fibrins, clogs)
 Bad pipeting controls, patients, calibrators (causing air bubbles and level sensing
problems error 2013)
 Using non-conform primary tubes (wasn’t mentioned at installation instrument)
 Placing sample cups not correctly in holders (can be interpreted as primary tube or
not detected sample)

 Nonchalant removing used test cups after analyzing while beads will fall in
incubator.
 Leaving sample cups and patients in the instrument after analyzing
 Not closing the front cover during analyzing
 Closing the substrate cap to firmly: can cause error 2017: substrate purge failure.
 Using wrong substrate replacement solution, should be 70% ethanol
How to find the solution? General Ideas:

1. Interrogating customer and service engineers: check history of the
instrument, analyzing aia360.dat file results,S and R signals.
2. Check possible environmental causes.
3. Check eventually if operator might have made mistakes.
4. Check with Tosoh if there are specific Lot number problems
5. Check the quality of the reagents: H20 in lab, calibrators, controls: use your
own H20 and make up new calibrators and controls with other H20.
6. Perform a complete general inspection (See chapter 13).
7. Perform specific tests based on the problem to eliminate specific modules or
sequences during analyzing (see also chapter 13).
8. Verify the liquid quantity in the cup after analyzing; all cups need to be filled
up equally with 200µL substrate.
9. Perform a Decontamination (see chapter 14.5)
10. Analyze results by classification using the table in 11.4 or do further tests to
get more data.
11. Perform a 0 concentration test using TROP or similar test like PSA2 or TSH
test to verify the performance of the wash probe and detector at noise level!
(See also chapter 11.5.1.) and perform as well the precision tests on a
positive sample to verify the sampling if the test in 11.5.1 was ok. (See also
chapter 11.5.2.)

11.3. IMMUNOLOGY REACTION IN AIA INSTRUMENT
11.3.1. Tosoh AIA cup:
1 cup = 1 test
1 cup = 1 specific analyte
1 cup = 12 magnetic beads with immobilized antibody/antigen + lyophilized
conjugate: enzyme labeled (ALP) antibody/antigen

11.3.2. One step sandwich assay:
Cup Content Addition of sample Antigen-Antibody

Reaction
 Designed for high molecular weight analyses (i.e. TSH, PRL, FER).
 Generally using higher sample volumes (20µL-100µL)
 Antigen in serum is sandwiched between the antibody which is chemically
bound to the bead and alkaline phosphates labeled antibody in the conjugate.
 Fluorescence (enzyme activity) is directly proportional to the concentration of
the test to measure.
 Curves are usually linear and most of the analyses use only two calibrators,
with the exceptions of BMG, CKMB, HGH, IRI and LH which require 6
calibrators.
 Calibration curve is expressed as rate versus concentration.

11.3.3. Competitive Binding assay:
Cup Content Addition of sample Antigen-Antibody

Reaction
 Designed for low molecular weight analyses (i.e. TT3, T4, FT4, E2, PROG).
 Generally using lower sample volumes (10µL-50µL)
 Antigen in the serum and the labeled antigen in the conjugate compete for
antibody sites on the bead. The antibodies are chemically bound to the bead.
 Fluorescence (enzyme activity) is reversely proportional to the concentration of
the analyze to measure.
 Limited amount of antibody is on the bead.
 Analyses require 6 calibrators.
 Calibration curve is expressed as B/B0 versus log of concentration ( the
percentage of the rate of the calibrator to the rate of the zero calibrator)

11.3.4. AIA Principle and Rate Calculation:
AIA PRINCIPLE (e.g. sandwich method)
Addition sample (antigen) +

Lyophilised diluent
conjugate
Reconstitution lyophilised
conjugate
Beads with
antibody
TOSOH BIOSCIENCE Dedicated to earn your trust. Confidential 18
AIA PRINCIPLE
Rate Detector
CPU
Rate= d4MU/dt
Incubation: Antigen- Wash Step: bound and Addition of Substrate:

antibody reaction free separation 4MUP→4MU
Fluorescence kinetics
detection
TOSOH BIOSCIENCE Dedicated to earn your trust. Confidential 19

11.4. Method of Elimination by analyzing and Classifications of Results:
Comp Sand Main Causes Caused By Solution and procedures to verify

Rate Conc Rate Conc
    1.Poor sample pickup

2.Poor dispensing of
1.-Leaking syringe seal
-Internal leaking Valve SV201
1.-Check for dirt at sample pickup syringe piston if so
replace seal 021098
sample in test cup -Air leaks at sample nozzle connectors -Check valve, flush tubing and sample probe with
-Sample surface bubbles, 2011 air detected was not syringe tool 940081
triggered -Check samples for bubbles
-Obstructed sample probe (related CL error) 2. Verify adjustments
2.- Wrong adjusted X,Y and Z in test cup: part of the -Perform EXAM, SAMPLING A test and weight cups
sample dispensed on the seal, poor seal breaking after sampling (see also chapter 13)
    1.Substrate diluted by
remaining wash solution
1.-Wash probe height (not deep enough)
-Insufficient vacuum pressure waste pump
1.-Adjust wash probe depth
-Proc BF prime with Hitachi
after suction (related with -Obstructed suction valve SV402 -Check vacuum and valves with vacuumcheckups
error 2016) -Dirty wash nozzle procedure and tool 940062
-Check valve and clean with syringe tool 940081
2.Substrate quality 2. -Old substrate -Clean wash nozzle
(related DL error) - No substrate (alcohol, related DL error) -Verify the Rsubanal with Rsubdaily in aia360.dat
viewer
3. Insufficient detector 3. -Detector Lamp low (related DL error) -Perform EXAM, SUCTION WASHER to verify if all
reading - Detector lens dirty 10 cups are empty (see also chapter 13)
-Piercing quality 2.-Use new substrate and always perform daily
4. Beads aspiration maintenance.
,losing beads 4. -Dirty wash nozzle 3.-Check Rsub value with 200µL substrate and
5. Insufficient reaction - Wrong fitted wash nozzle (stylus too deep inside wash compare with Rsubini
during incubation nozzle) -Clean detector lens
- Wrong depth (too deep) -check and adjust seal breaker
5. - Insufficient diluent take-up: sample probe not deep 4.-Clean wash nozzle
enough in diluent port or diluent pump supply problem -verify stylus level versus wash nozzle and adjust
- Temperature incubator/Wash too low (should be at same level)
-adjust depth wash nozzle
5.-Adjust diluent position for diluent pickup.
-Check diluent supply pump and valve SV202
-Adjust temperature wash and incubator

    1. Wash Supply (related

with error 2015)
1.-Air bubbles in wash line as wash is almost empty
-Leaking wash at wash heater connectors
1.-Check wash quantity and tubing inside the bottle
-Perform proc BF prime with Hitachi
2. Substrate Supply -Leaking wash at valve SV401 -Check wash tubing for damage at connectors
(related with error 2017) -Internal leaking valve SV401 -Check valves with syringe tool 940081
3. Insufficient Wash -Leaking seal wash syringe -Check syringe for dirt at piston if so replace seal
Suction 2.-Almost empty substrate causing air bubbles in substrate 021098
4. Conjugate sticks at test line -Perform the EXAM, WASH DIP test and verify
cup side -Internal leaking valve SV501 quantity of wash in the 10 cups(see also chapter 13)
-Leaking at valve SV501 connectors 2.-Check substrate quantity
-Obstruction in substrate tubing: dried up substrate caused -Verify Rsubanal with Rsubini in the aia360.dat file.
5.Temperature problem by not performing shutdown with alcohol -Check valve with syringe tool 940081
(too high) -Leaking substrate seal -Flush substrate tubing with alcohol and tool 940081
-Substrate cap fitted to firmly by customer creating vacuum -Check for dirt at substrate syringe piston if so replace
inside the bottle seal 021098
3.-Dirty wash nozzle -Check substrate closure cap
-Insufficient vacuum waste pump -Perform the EXAM, DRIP SUBSTRATE to verify
-Obstructed SV402 valve substrate delivery in the STD cups. (see also chapter
-Wash probe not deep enough in testcup 13)
4.-Test cups preserved upside down 3.-Clean wash nozzle
-Customer shaking test cups -Check vacuum with tool 940062
5. Temperature Incubator/wash too high. And use vacuumcheckups procedure to check valve
SV402
-Flush all waste tubing and valve SV402 with tool
940081 and alcohol
-Perform EXAM SUCTION WASHER and the 10 cups
need to be empty. (see also 13)
4. Check operator, instruct operator
    1. Too much sample
pickup
1. Sample probe too deep in sample during level sensing
(related with error 2014,2010) sample sticks at outside of
1. Full checkup level sensing: Handtouch and macros
sample probe (mostly problem with low sample volume)

UNDEF UNDEF 1. Combination of above 1.-General verification instrument see chapter 13.
problems 2.-Decontamination and make up new wash, diluent
2. Instrument and substrate.
Contamination -Use new H20
3. Detector 3. -Verify detector stability by placing empty and
pierced STD cup under detector and monitor S0 and
R0 values, MECH CHECK, DETECTOR
-Verify S and R values in AIA360.Dat file.

11.5. Method of Individual and combined Process tests

 As seen in chapter 11.4 ‘analyzing of results’ the unstable results produced by the
AIA instruments are mostly caused by a malfunction in the following process:
 Sampling
 Washing
 Substrate dispensing
 Detector measurement
 Here below some tests that can be performed to verify the detector stability,
washing process, substrate dispensing and sampling. Details to perform these
tests are explained in chapter 13.3: General Verification.
11.5.1. Method of individual tests:
 Sampling: Perform EXAM/SAMPLING A to verify sampling volume in the cups.

(only for large uptake 100µL)
 Washing: Perform EXAM/DRIP WASHER and EXAM/SUCTION WASHER and
Vacuum Tool Verifications.
 Substrate Dispensing: Perform EXAM/DRIP SUBSTRATE
 Detector Measurement stability: Verify the AIA.dat results S and R for stability
and verify the stability in an empty STD cup with MECH TESTS, DETECTOR and
monitor the values on the display.Do the same for a cup filled with 200µL
substrate.
11.5.2. Method of Combined Tests:
 Washing, Substrate, Detector: Perform a precision test by running a TROP,

PSA2 or TSH test on a 0 level sample (use diluent solution) to check the detector
noise level and wash performance. Place the 0 sample in positions 1 and 5 and
place 8 TROP reagent cups in the positions 1 till 8. The rate values should be
within range:
RATEtrop < 0.15 and stable
• Make sure all covers closed when performing this test!
• Rates can vary upon type and initial adjustment of the detector.
• Rate stability should be focused on!
• Flyers (intermittent high rates) can be caused by bad washing cycles or wrong
mechanical wash station adjustment!
 Sampling: If above TROP test is OK. Perform a precision test on a positive
sample with a sandwich test like IGE2 (10µL sample volume) and like TSH (100µL
sample volume). If this test is ok then your instrument is performing correctly.

11.5.3. Procedure to follow to troubleshoot flyers or instability in

very low rates or very low results (e.g.troponine test)
 Perform 4 times a 0 concentration test and analyze the rate results to confirm that
there is a problem (can be done with TROP,TSH or PRL)
 If instability is detected perform the following tests to eliminate the following
modules:
 Washing: perform the B/F tests with Hitachi cup, perform the EXAM tests WASH
DIP and SUCTION WASH and verify the wash delivery and suction. (see also
chapter 13)
 Substrate: Verification of substrate delivery can be done with EXAM Drip
SUBSTRATE. (see chapter 13)
 Detector: Verify the AIA.dat results S and R for stability and verify the stability in an
empty STD cup with MECH TESTS, DETECTOR and monitor the values on the
display.

12. ERROR TROUBLESHOOTING:

12.1. MOST FREQUENT ERRORS AND WARNINGS
1. Error 2015 : BF PROBE PURGE FAILURE daily mainte

2. Error 2016 : BF PROBE SUCTION FAILURE
3. Error 2017: SUBSTRATE PURGE FAILURE daily mainte
4. Error 3021 : LEAK SENSOR S701 DETECTED
5. Error 3022 : LEAK SENSOR S702 DETECTED
6. Error 2010 : SAMPLE LEVEL FAILURE
7. Error 2011 : AIR DETECTED SAMPLE
8. Error 2013 : SAMPLE LEVEL DETECTION ERROR
9. Error 2014 : SAMPLE SHORTAGE DETECTED
10. Error 4043: WASH SYRINGE HOME SENSOR ERROR
11. Error 4045: WASH SYRINGE HOME OVERRUN
12. Error 4044: WASH SYRINGE HOME NOT FOUND
13. Error 4002: TURN TABLE HOME NOT FOUND
14. Error 4001: TURN TABLE HOME SENSOR
15. Error 4003: TURN TABLE HOME OVERRUN
16. Error 4004: TURN TABLE SLIP
17. DL flag
18. HB flag
Remarks: Full list is available on ISAP/AIA_SERVICE/AIA360/Troubleshooting

See T109 for error code interpretation in case of ‘Specimen Task Error’
Errors: 4012, 4013, 4014 similar for syringe specimen
Errors: 4048, 4049, 4050 similar for syringe substrate
12.2. BF PROBE PURGE FAILURE ERROR 2015
Main cause: The sensor S402 was not triggered at the end of the wash cycles
(turntable drain position should be filled up with wash) during daily maintenance or
wash replacement when the wash probe was moving down to see if there was liquid.
S402 measures conductivity between dispensing stylus and outer metal tube of the
wash probe. LED 4 on the sens board lights up when a certain level of conductivity is
reached (threshold: cannot be adjusted)

Caused By Solution
Air bubbles in wash solution Checks were bubbles occur and check
tubing damage at connectors. Check if
tubing is present in the wash solution
Internal leaking valve SV401 Check Valve with 940081 tool, clean
valve or replace
External leak at valve tubing Fasten connectors
Leaking syringe seal (dirt at piston) Replace seal 021098
Wrong concentration wash solution Replace wash solution
Leaking wash solution at wash heater Fasten with extra tire wrap or perform
connections T082 and check Z- adjustment wash
probe (see T116)
Sensor cable Check cable and sens board LED4

12.3. BF PROBE SUCTION FAILURE ERROR 2016

Main cause: The sensor S402 is triggered during wash cycles suction period when the
wash probe is moving down in a test cup filled up with liquid. LED 4 on the sens board
lights up.
Caused By Solution
Valve SV402 obstructed and no suction possible Replace or clean valve SV402
Waste pump LP401 malfunction Check vacuum with tool 940062
Air leaks at connectors or damaged tubing Replace tubing and fasten
(pinched tubing) connectors
Clean wash probe or replace
Wash probe obstructed by dirt or beads nozzle
Dismantle probe completely and
fasten firmly the Teflon flanged
Internal leakage probe causing false conductivity part.
Wrong adjusted wash probe X,Y or touching the
cup border (false conductivity) Readjust the wash probe X,Y
Valve SV204 unable to close and causing Verify valve SV204 with syringe
insufficient suction tool 940081
12.4. SUBSTRATE PURGE FAILURE ERROR 2017

Main cause: The sensor S402 was not triggered at the end of the substrate
replacement procedure (when the turntable drain position is filled with substrate) when
the wash probe was moving down to see if there was substrate present. LED 4 on the
sens board did not light up.
Caused by Solution
Insufficient substrate (air bubbles) Check were air bubbles occur
Valve SV501 leaking or malfunctioning replace or clean SV501
Leaking substrate syringe due to seal Replace plunger seal
Obstructed substrate tubing caused by not Use tool 940081 to flush tubing with
performing daily check alcohol
Valve SV402 unable to close and causing
continuous suction Replace or clean valve SV402
Tubing damaged and connector leaks Replace tubing and fasten connectors
Substrate bottle cap too fastened and causing
vacuum in the bottle Check cap

12.5. LEAK SENSOR S701 DETECTED ERROR 3021

Main cause: The conductivity sensor S702 in the basin under the wash probe was
triggered as it detected liquid. Error mostly related with 2016.
Caused By Solution
Fasten connectors, check valve
Leaking tubing connector at valve SV501 leaking
Leaking substrate syringe Replace seal plunger
Leaking or disconnected tubes at BF wash Check tubing, Perform TB82 to
probe prevent leakage at wash heater
Condensation, Humidity Check instrument location
Insufficient wash suction in reagent cup (see
error 2016) causing overflow Check vacuum at waste pump
Disconnect sensor and check sensor
Faulty sensor board status
12.6. LEAK SENSOR S702 DETECTED ERROR 3022

Main Cause: The conductivity sensor S702 in basin under the wash heater is triggered
as it detected liquid. Can be related with error 2015.
Caused by Solutions
Leaking or damaged wash heater tubing Fasten or replace tubing
Leaking valve SV401 Replace valve
Condensation, Humidity Check instrument location
Disconnect sensor and check sensor
Faulty Sensor board status
Loose connector at valve SV401 Tight connectors
12.7. SAMPLE LEVEL FAILURE ERROR 2010

Main cause: ∆ ADliq > TH in Non-Liquid Zone
Caused by Solution
Cable broken EKI and Sens Board Measure cable
Noise caused by EMI Check shielding, and environment
Noise caused by Vibrations Check bearings
Check Damper
Check Tension Belt
Check Feed Screw Z-movement

Defective EKI board Replace EKI board
12.8. AIR DETECTED SAMPLE ERROR 2011

Main cause: |ADliqsurface – ADaftersuction| >= THair
Explanation: After the level detection the CPU is monitoring the AD signal during the
Liquid Suction. If the difference between AD before suction and after suction is
exceeding a preset value THair, then 2011 is produced.
Monitoring: Sample probe stops before reaching Liquid, Bubbles.
Caused by Solution
Air Bubbles on Sample Surface Check Sample, Operator
Noise caused by EMI Check shielding, and environment
Noise caused by Vibrations Check bearings
Check Damper
Check Tension Belt
Check Feed Screw Z-movement
Noise by elec. fluctuations Check Grounding
Wrong Offset value Recalibrate Offset Value
Wrong LevelCalPulse Verify this parameter =0

12.9. SAMPLE LEVEL DETECTION ERROR 2013

Main cause: ∆ ADliq < TH or Threshold cannot be reached
Caused by Solution
No sample Check sample and operator
Wrong Zmaxtube Readjust Zmax parameter
Disconnected Sample probe Check wire from EKI board
Wrong setting OFS value Recalibrate Hand touch value
Crashed sample probe stylus Replace
Wrong adjusted sample probe Adjust X and Y
Defective EKI board Replace EKI board

12.10. Sample Shortage Detected Error 2014

Main cause: Stube X (Zmaxtube-ZLiqdet) < Death Volume
Explanation: The Level sensing is ok but the remaining volume calculated is too low to
perform the tests.

12.11. WASH SYRINGE HOME SENSOR ERROR 4043

Main Cause: Sensor S403 remains on during down movement
Caused By Solution
Coupling position and/or screws Check coupling position and fit screws
loose
Stiff movement feed screw -Clean feed screw with 940076 and grease
-Replace feed screw 021797
Motor current insufficient -Check and increase motor current
Worn out syringe seal -Replace syringe seal 021098
12.12. WASH SYRINGE HOME OVERRUN ERROR 4045

Main Cause: Sensor S403 is activated too soon during the up movement as the
stepper motor lost steps during down movement
Caused By Solution
Coupling position and/or screws loose Check coupling position and fit
screws
Stiff movement feed screw -Clean feed screw with 940076
and grease
Motor current insufficient -Check and increase slightly
motor current (turn CW)
Alignment motor axe and feed screw Check and adjust alignment
Motor defective Replace Motor
12.13. WASH SYRINGE HOME NOT FOUND ERROR 4044

Main Cause: Sensor S403 is not or too late activated during the up movement as the
stepper motor lost steps
Caused By Solution
Coupling position and/or screws loose Check coupling position and fit screws
Stiff movement feed screw -Clean feed screw with 940076 and
grease
Motor current insufficient -Check and increase motor current
Obstruction in the wash supply Check tubing for obstruction with
940081 Tool Syringe

12.14. TURN TABLE HOME NOT FOUND ERROR 4002

Main Cause: Sensor S101 (pitch sensor) and S102 (home sensor, led 2) cannot find
the condition S101 OFF and S102 ON; synchronization
Caused By Solution
Wrong adjustment pitch Adjust detector position with
sensor S101 and adjust S102
Encoder disk S101 loose Check and fix encoder disk
Sensor broken Check sensors
12.15. TURN TABLE HOME SENSOR ERROR 4001

Main Cause: Sensor S102 (home sensor, led 2) remains activated, turntable stops
Caused By Solution
Turn table PM101 motor Replace motor
defective
Driver board or motor current Check driver board and motor
current
Turntable obstruction Move manually the rotor and
check for obstructions
Sensor S102 remains on even Check sensor S102, check LED 2
when turntable moves on sens board
12.16. TURN TABLE HOME OVERRUN ERROR 4003

Main Cause: Sensor S102 (home sensor, led 2) exceeds the designated operating
range.
Caused By Solution
Motor belt or sprocket loose Check belt and sprocket
Turntable sprocket and motor Check slip, adjust
sprocket distance (slip)
12.17. TURN TABLE SLIP 4004

Main Cause: The passing number of sensor S101 (pitch) during turning the table is
checked, or the motor PM101 lost steps
Caused By Solution
Turntable obstruction (dirt, beads Move manually the rotor and
in sprocket) check for obstructions
Turn table PM101 motor Replace motor, check cable
defective or cabling
Driver board or motor current Check driver board and motor
current

Remark: Errors: 4012, 4013,4014 similar for syringe specimen

Errors: 4048, 4049, 4050 similar for syringe substrate
12.18. DL flag
Main Cause: When Rsub/Rsubini < 0,5 (SubIniRefChk)
Caused By Solution Verification
Insufficient substrate in substrate Replace substrate Check Rsub value by
bottle or substrate empty placing manually a
cup with 200µL
substrate under the
detector.Perform
Detector Light
reading, the check the
Rsubini in the Exam
Menu Detector
Calibration Info
Substrate suction tubing not in Check

substrate
Substrate bottle rubber cap firmly Check rubber cap
closed preventing pressure
stabilization
External leaks at substrate Replace seal or fix valve
syringe or valve. fittings.
Substrate quality (too old) Replace substrate Check Rsub value by
placing manually a
cup with 200µL
substrate under the
detector.Perform
Detector Light
reading, the check the
Rsubini in the Exam
Menu Detector
Calibration Info
Detector was replaced without Check Rsub value by
detector calibration placing manually a cup
with 200µL substrate
under the
detectorCalibrate
detector
Detector was adjusted without Check detector
detector calibration adjustments and
recalibrate detector
Detector wrongly adjusted or Check adjustments or
defective replace detector.

Calibrate detector
Insufficient wash probe suction Check if instrument is Check cups liquid
causes substrate dilution and low not causing 2016, quantity after
Rsubanal perform the suction test analyzing, should be
manually with Hitachi equal for all cups and
cup around 200µL
Some cups have bad piercing Check seal breaker Verify all cups after
analyzing for piercing
quality
Dirty detector lens clean Lens
Wrong adjusted detector reading Adjust reading position Remove detector and
position verify reading position
with pitch sensor
S101=OFF
12.19 HB Flag
Main Cause: 4MUt=0 < 1500 or during daily maintenance
Caused By Solution Verification
Old substrate Replace substrate During daily
maintenance the 4MU
is printed out. Also
you will see a higher
S1 value.
Contaminated Substrate Replace Substrate and

decontaminate the
substrate lines. This can
be done with 0.1 HCL or
use tablets 940051
Substrate is ok but substrate decontaminate the
lines are contaminated substrate lines. This can
be done with 0.1 HCL or
use tablets 940051
High Substrate temperature Readjust the
temperature
HB only during analyzing:Caused Dilute the samples
by High concentration samples
Detector replacement without Readjust detector and
calibration Recalibrate detector
Detector adjustment without Recalibrate detector
calibration

13. GENERAL VERIFICATION

Basic procedures that can be performed by trained operators to verify and/or repair
the instrument prior to contact the Tosoh Service Responsible.
13.1. VISUAL INSPECTION WITHOUT COVERS REMOVED

13.1.1. Turntable inspection: Drain position, beads, dirt
 Press ‘sample feed’ and inspect the turntable test cup holders for dirt and
beads
 Look in the turntable drain position and remove the beads if any. Beads
indicate: bad wash delivery, dirty wash probe
 Dirt around the drain position indicates bad washing (suction)
Turn Table Drain Position:

Check for beads!
13.1.2. Movement Turntable with power off

 Switch of the main power and turn the turntable manually.
 Feel if there are any obstructions, dirt or beads: remove the beads and the dirt
(sometimes beads can be caught in the turntable sprocket, the turntable will
then be obstructed at a specific position)
13.1.3. Drain tubing

 Check the drain tubing in the back of the instrument, check if there is or was
liquid inside, if so call Tosoh Service. Liquid in the drain tubing indicates
serious leakage inside the machine and is related with errors 2016

Drain Tubing:
Check if there is
or was liquid
inside
13.1.4. Waste, Diluents and Wash tubing, connections

 Check the condition or damage of the tubing connected from the bottles to the
instrument: leaks can cause bubbles in the diluent line and cause bad results,
bubbles in the wash line will cause error 2015: wash purge failure
 Check also the tubing inside the bottles for damage
13.1.5. Check piercing quality

 Check the quality of the piercing after analyzing: bad piercing will influence
detector reading:

Good Bad
13.1.6. Check amount of substrate in test cup after analyzing

 After the analyzing the test cups need to be filled equally with the same
amount of substrate (200µL)
 Too high: the wash suction was bad and can cause error 2016, this will
influence results
 Too low: the substrate supply is bad: air bubbles in substrate line, substrate rubber
cap to firmly closed. Can be related with error 2017 during daily maintenance.
13.2. BASIC TESTS WITHOUT COVERS REMOVED

Press ‘SPECIAL MENU’ and then ‘MAINTE’
Following tests are available:
1. ALL SET HOME
2. SUBSTRATE BG MEASUREMENT
3. PRIME SAMPLER DILUENT
4. WASH SAMPLER NOZZLE
5. PRIME BF WASHER
6. REPLACE SUBSTRATE
7. TESTCUP READ
8. DETECTOR LIGHT
9. DETECTOR DARK
Perform an all set home to see if no errors occur

13.2.1. Perform 3, 4 and 5

 This will prime the diluent (3), washing the sampler nozzle (4) and priming the
wash in the turntable drain position (5) with the wash probe.
 Check the wash and diluent lines for bubbles
 Performing 5: Prime BF Washer can cause error 2015: purge failure if the
wash lines and wash heater is not filled up completely with wash solution. If
the lines are empty Prime BF washer needs to be performed at least 6 times.
13.2.2. Perform 2: Substrate BG Measurement
 Perform first 6: Substrate Replace to make sure the substrate line is
completely filled with substrate.
 Now Place an STD cup in position 1 and perform 2
 Compare the values obtained with the detector information: EXAM MENU/ 20
DETECTOR CABLBRATION/ press ‘MENU’. The values Background and
Substrate should be from the same order:
13.2.3. Perform 8: Detector BG substrate measurement
 Place a manually pierced STD cup with exact 200µL substrate in position 1 of
the turntable.
 Press ‘SAMPLE FEED’ 14 times, this will bring the cup under the detector.
 Now perform 8 and check the values with the value obtained while performing
2 or daily maintenance.
Remark: This test is testing if the substrate dispensing quantity during daily
maintenance is correct!

13.2.4. Daily Maintenance

 Perform a daily maintenance; this will check all mechanical movements,
background and substrate measurement.
 Check the printout:
Problem Caused by solution
SubstrateReplacementCheck NOK Substrate quantity or Use new substrate,

quality. perform 8: Detector
Detector defective. light measurement
with STD filled with
Detector wrong ini 200µL substrate
values
Lamp Low LL Detector calibration Recalibrate,

INI values, decrease LampChk
temperature, Detector value, replace
Noise detector
High Blank HB Old substrate, Replace substrate,

contaminated decontaminate with
substrate lines 0.1 N HCL
Values background S0, R0 too high Front cover was Close front cover
(>600) open, detector
problem
Value S1 too high (this will cause Old substrate, Replace substrate,
HB)verify also 4MU value detector problem. replace detector.
Decontaminate
substrate lines with
0.1N HCL
Value R1 too low (< 25000) (check Substrate quantity, Perform 8: Detector
the Rsubini in detector calibration substrate quality. light measurement
data) with 200µL
substrate, use new
substrate

13.3. EXAM MENU TESTS
Remark: Enter the TEST mode to get access to the EXAM menu. Most important
tests that can influence the result are mentioned
13.3.1. Sampling A to test the sampling volume:

 Level sensing, sample pickup and dispensing can be monitored by performing
this test.
 Place 4 pierced STD cups in position 1 to 4 and 4 pierced STD cups in
position 5 till 8. Then place 2 sample cups with 2mL diluent in positions 1 and
5.
 Perform EXAM MENU, SAMPLING A
 Level sensing and 100µL suction and dispensing will be performed 4 times for
STD cups 1 till 4 and 200µL for STD cups 5 till 8.
 Verify the quantity of the volume in the cups or weight them.
13.3.2. Wash Dip test:

 Wash is dispensed 10 times in an empty STD cup and volume needs to be
verified.
 Place 10 pierced STD cups in pos 1-10 and perform EXAM , WASH DIP
13.3.3. Suction Washer test:

 Wash solution is aspirated from the STD cups and all cups need to be empty.
 Place 10 pierced STD cups filled up with at least 200µL of liquid or perform
this test after the ‘Wash Dip test’. Perform EXAM SUCTION WASHER
 Verify the remaining volume in the cups. Should be all empty.
13.3.4. Drip Substrate test:

 Substrate is dispensed in empty STD cups.
 Place 10 pierced and empty STD cups and perform EXAM DRIP SUBSTRATE
 Verify the quantity visually or by weighting the cups.
13.4. VISUAL INSPECTION WITH COVERS REMOVED

Remove the back cover and the main white cover.
13.4.1. Inspect wash probe
 Verify the wash nozzle, replace or clean.
 Check if any cables or tubing can obstruct the wash nozzle movement
 Check manually the up and down movement
 Verify if you see crystallization or dirt around the incubator wash probe hole
 Verify if there is dirt on the metal outer part (internal leakage probe)

 Verify if the wash nozzle is fitted correctly: The metal stylus inside the white nozzle and
the nozzle should be at the same level.
 Verify if wash dispensing and suction tubing is connected correctly
 Place the wash probe back and check if tubing and cables
Check manually
the up and down
movement
(spring) Loose this screw
to remove the
wash probe
Inner stylus and

nozzle have to be at
the same level

13.4.2. Inspect incubator cover for dirt

 Check the incubator cover for dirt and investigate from where the dirt is
coming: leaking tubing, valve, sample nozzle...
13.4.3. Inspect syringes for dirt at piston fixing plate

 Dirt located on the piston is an indication that the seals need to be replaced
urgently.
Piston fixing plate
13.4.4. Inspect Sample Probe condition

 Check if the sample probe is aligned and straight
 Check with 940081: Tool Syringe to check obstructions and to decontaminate.

13.4.5. Check for other abnormal dirt caused by leakage

 Check in the instrument if you notice dirt caused by leakage: turntable, wash
heater (see T082 for improvement)
Leaks might occur here!

(Pressure buildup during
wash purging)
 Remove the blue cover behind the bottles and check for leakage around the
pumps and valves.
Valves
Drain Pump,
output to
waste bottle
13.5. BASIC TESTS WITH COVERS REMOVED

Remove the main white cover.
13.5.1. Wash Sampler Nozzle, Diluent replacement
 Perform 3 and 4 in the mainte menu and watch the positions of the sample
probe in the diluent port and wash port
 Check the diluent delivery
 Check the wash delivery during the sampler nozzle cleaning

Wash position Diluent position
13.5.2. BF prime with Hitachi Cup

This test is very important to verify the BF separation in the testcup. If there is air in
the wash lines Perform 5: Prime BF washer a few times until all air is removed or
until error 2015 disappear.
 Unscrew the wash probe and place it manually in a Hitachi cup.
 In mainte menu perform 5: Prime BF washer
 Verify the smooth wash dispensing (no bubbles and equal volume) and the
fast suction, repeat a few times.
 Additional perform the Vacuum test as explained in
ISAP/GeneralService/VacuumCheckup to verify the drain pump performance
and valves. Reading is around 0.8 bar and needs to be stable!
Check wash purging and wash suction

manually in a Hitachi Cup: Perform BF
wash replacement.

13.5.3. Inspection other Sample probe Positions

 Enter the TEST mode: Start instrument while pressing MENU and hold menu
until you hear a beep.
 Press SPECIAL MENU, press MECH CHECK, select 5 SAMPLER, select 4:
COMPOUND ACTION
 Place an STD cup in position 1 and press 5 times, the cup is now at the
sample dispense position
 Select 3: Move testcup position and verify the position
 Remove the back cover.
 Now place manually a sample cup with 500µL H20 in position Nord of the
turntable.
 Perform 11: Level Dtetct (sample1)
 The sampling nozzle will take some diluent and will then move to the sample
cup to perform a level sensing.
 The sampling probe will move down in the sample cup. Check if the sample
probe is positioned in the middle of the cup.
 The sampling probe will touch the surface of the liquid in the cup and will move
up again (level sensing)
 The volume in the cup is measured and is indicated on the display (around
400)
Level sensing
test: Probe will
touch the liquid
and will move
up again. Then
the volume is
calculated.
13.6. Run Samples with all covers refitted

 Run a 0 concentration sample for TROP,TSH or PLR to verify the Rate stability (see
11.5)
 In TEST mode select MECH CHECK, DETECTOR and verify detector stability in an
empty and pierced STD cup
 Run a precision test: e.g.: 5 times sandwich, 5 competitive test on a positive sample
and verify CV’s.

14. MAINTENANCE:
Maintenance for the AIA-360 is normally foreseen ones a year. Additionally every 20000
tests or once every 3 years the diluent, wash and waste pumps need to be replaced. This
maintenance procedure is the result of practical experience and is build up in 6 steps.
An additional maintenance for customers is recommended every 4000 tests and consists
out of a visual inspection, clean or replace the wash nozzle.
For the official Tosoh maintenance procedure please see App 7. There are 2
maintenance kits available: 910287 Yearly Maintenance and 910228 3-yearly
maintenance kit (with pumps)
First interrogate the customer about existing problems or if he has special remarks about
the functionality of the instrument.
14.1. CLEANING:
Remark: Dirt is a very good indicator of existing problems. It can be caused by

leaks, broken valves or pumps and wrong adjustments! Always try to find what
causes the dirt!
 Remove the covers: Back, front and middle and general clean the instrument
with Wipes to clean. You can use 940074 Tool Wipes to clean, 940083 Tool
cleaning Decont. lingettes
 Remove the dust and clean ventilators.
 Check the instrument for leakage: at the S701 and S702 sensors, at the
bottom of the bead collector, at the wash probe area, at the wash heater input
and output, at the pump chassis plate.
 Clean the Turntable especially at the turn table drain position
 Clean the seal breaker
 Dismantle and clean wash probe completely if very dirty, illustration:
 Clean all the parts and refit the probe, make sure to tighten all parts firmly to
prevent air leaks.
 Sample probe and flush with 70% alcohol: use the new tool 940081: Tool
Syringe for M5 F&M
 Clean sample probe outside

 Remove beads in the carousel turn table drain position. Verify by means of a
flashlight the gear on the carousel to assure no beads are caught in the gear.
Remove beads that dropped in the turntable.
 Check status of the sample probe, bent? Try to fix or replace.
 Detector lens cleaning.
 Remove the substrate dispenser and clean point.
14.2. REPLACEMENTS AND MECHANICAL IMPROVEMENTS:

Remark: check for mandatory maintenance upgrades in the TosohCatalogue by
serial number or refer to next chapter 14: upgrades and improvements.
Update the software to latest version and check the technical bulletin for
eventual parameter updates!
 Replace the wash probe tip : 020107 (6 pieces in one package)
 Replace the tank filters : 018585 (10 pieces in one package)
 Replace seal: washing, substrate, dispensing syringes: seals 021098 X 3
 Replace the external tubing from waste, wash and diluent: tubing 020235 or
940039 (OD 5mm x ID 3mm x 15m)
 Check all other tubing’s and replace if necessary: Tygon tubing used in AIA-
360: 940036,940034,940037.
 Every 3 years or 20000 tests: replace diluent and wash pump: 021124 and
waste pump:021567

14.3. MANUAL CHECK MOVEMENTS AND LUBRIFICATION:

Remark: Grease can be removed with grease dissolvent or Soft Surface cleaner
940076, use tri-flow oil 940069 or super lube plus 940071 to lubricate feed screws
and bearings.
 Renew grease from feed screw dispensing syringe
 Free pulse motor, turn the couplings of the syringes and check the stiffness of
the movement. If movement is stiff, clean the feed screws with Soft Surface
cleaner, WD40 or acetone and grease. If still not ok replace the feed screw:
021797
 Renew grease from feed screw dispensing syringe
 Renew grease from feed screw washing syringe
 Renew grease feed screw substrate syringe
 Check movements Z-axis and R-axis guide from the dispensing arm and
grease always after removing the dirty grease or oil.
 Check all movements manually with FREE PULSE and look for mechanical
obstructions.
14.4. ADJUSTMENTS CHECK AND TESTS:

 Check the different positions of the sample nozzle (see 8.3. adjustment check)
with the compound actions.
 Verify the cup piercing quality by examining pierced cups and adjust if
necessary.
 Verify the position of the wash probe
 Verify the waste pump vacuum pressure (see vacuum pressure procedure on
ISAP/GENERALSERVICE/VacuumCheckups) if not within range, clean or
replace the pump. It’s recommended to use vacuum tool 940062
 Verify the suction of the wash probe (see 13.5.2)
 MECH CHECK, SAMPLER, CLOG AD: check the stability of the pressure.
 Perform the EXAM SAMPLING A test (see 13.3.1) and verify all movements.
14.5. DECONTAMINATION AND LIQUID FEED TEST:

 Prepare decontamination solution. Tablets order nr: 940051 and use 1 tablet
for 5 liter H2O. Or use a 3 % Hypochlorite solution.
 Place diluent and wash lines into the bottle with decontamination solution and
perform 4 times SPECIAL MENU, MAINTE, PRIME DILUENT than 4 times
PRIME WASH and 6 times PRIME B/F PROBE.
 Clean the diluent and wash bottles with the Hypochlorite solution.
 During the purging monitor the liquid diluent purge, wash probe suctions and
check for leaks.

 Wait at least 0,5 hour.

 Place wash and diluent lines into a bottle with distilled water perform PRIME
DILUENT, PRIME B/F PROBE ones more.
 Prepare new diluent and wash solutions and fill up the cleaned containers.
 Replace the tank filters, never use filters that were in contact with bleach.
 Place back the wash and diluent lines in resp. containers and perform 4 times
PRIME DILUENT than 4 times PRIME WASH and 6 times PRIME B/F PROBE
until all lines are replaced with diluent and wash.
 Replace substrate bottle with HCL 0.1N and flush at least 4 times.
 Make new substrate and replace, flush again 2 times with the new substrate.
 Perform daily maintenance and verify Rsub (R1) with Rsubini. EXAM MENU,
DETECTOR CALIBRATION, INFO to verify lamp condition.
14.6. PRECISION TEST:

Perform the tests as explained in chapter 11.5.1 Precision test on a 0
concentration sample and 11.5.2 precision tests on a positive concentration.
14.7. ADDITIONAL MAINTENANCE:
 Every 4000 tests the customer or the service engineer needs to clean or
replace the washing nozzle. The procedure to remove the panels and the
washing probe is explained in T029. Technical bulletin T057 explains the new
type of substrate holder that makes the removal of the panels easier.
Instruments from #1701 have that option.
 Customer should regular check the turn table drain position for beads and dirt.
Instruct the customer to report any leaks or abnormal dirt that has been
observed.

15. UPGRADES AND TB’S:

 Here is an overview of most important upgrades and modification since the launch of
the instrument.
 Verify the serial number of your instrument to find out which upgrades need to be
performed on your instrument. New delivered instruments and refurbished
instruments are already upgraded. Instruments bought from 3th parties need to be
verified.
 The complete list is available on the ISAP and also listed in the TosohCatalogue.
TB FROM SN SUBJECT REL PART # IND

6 0300 Wheel securing bar 021206 1 URGENT
11 0297 Affixing position labels Service HQ 1 label VOL
16 0896 Syringe pump improve 021566 3 VOL
22 0941 Affixing recycle label Service HQ 1 label INFO
25 1001 Connection joint 021211 1 VOL
25 0793 Syringe drive unit 021797 3 VOL
36 1151 Label caution for uncap 021751 1 INFO
41 1351 Fixing coaching clip NA 1 clip VOL
45 1181 Wires securing sampling arm NA 0 VOL
50 0792-1200 New feed screw 021797 3 MAINTE
54 1601 Modification wash probe fix NA INFO
55 1601 Modification damper spring 021787 1 VOL
57 1700 Modification substrate holder 021066 1 INFO
75 3201 Change of camera 021113 1 INFO
82 3461 Change in fixing tubes wash 023100 VOL
84 3471 Protected samp Z-axis motor 021122 1 VOL
81 3401 Change Harness level sens 021215 1 INFO
86 3651 Protection cover Supply board 023106 1 MAINTE
87 3601 Change of the light source LED of 021109 1 INFO
detector
88 NA PCB board for level sensor 021215 1 INFO
93 NA Change in the criteria for cup reader NA 1 INFO
100 4101 Upgrades of the main & Power board 021132/021135 1 INFO
104 1041-1860 Readjustment of motor current NA VOL
105 4205 Modification of the arm rotation mech NA INFO
108 NA Possible mix up PCB board EKI 021215 INFO
109 NA Specimen Task Error INFO
116 NA Adjustment for Z-axis height wash MAINTE
probe
120 NA Change of coupling of syringe unit 023281 1 INFO
123 4986 Change of Elec current for LED camera 021113 VOL
148 NA Printer no feeding after being turned on INFO
149 6161 Main CPU board from V4R1 to V5R0
155 6501 New Main board with USB availeble 023300 INFO
159 6951 Upgrade Power board V3R0 to V5R0 021135 VOL
163 6951 Change Sens Board 021134 INFO
Remark: The relation between serial number, sequence number:
Every instrument has an 8 digit number: 12345678

Position 2346 is the sequence number.
Example: An AIA-360 with serial number 11657110 gives us following information:
Sequence number: 1651

16. INSTALLATION:
For detailed installation procedures please see service manual or ISAP. The following is a
quick installation procedure. The installation program in the software can also be used to
install the instrument. Do not forget to verify needle and general adjustments during
installation!
 Unpack the instrument and remove the 3 screws securing the sample arm at the back
of the instrument. Attach the metal plate over the hole.
 Remove the screws on the back panel securing the turntable
 Connect waste, wash and diluent tubing and level sensing wiring, respecting the
colors.
 Install the waste, diluent and wash bottle holder
 Install printer paper.
 Make up fresh diluent, wash and substrate.
 Remove the white middle panel and start the instrument in the test mode. In
SYSTEM set YES for ‘rate printout’ parameter
 Perform all sample probe adjustments as explained in chapter 9.2.
 Verify all other adjustments in particular wash probe X,Y and Z
 Flush diluent 2 times, wash 6 times and substrate 2 times.
 Switch off and on instrument and perform a daily maintenance
 Check the background and substrate values.
 Perform a precision test on a blood sample prior to calibration! (e.g.: run 5 times a
patient for FT4, TSH or any other test and evaluate the CV on the rates)
 If rate values are ok, switch off the instrument and enter the test mode.
 Program or enter all assay specification for the tests to calibrate.
 Perform the calibrations
 Perform the ‘Installation Validation Sheet’ to check if instrument is ok
(ISAP/AIA_SERVICE/AIA360/INSTALLATION/…)

17. ISAP & TOSOHCATALOGUE:

ISAP (Integrated Service & Application Platform) contains all available service, software
and application documents.
The TosohCatalogue is an access 2012 application helping you to find all spare parts,
reagents and technical bulletins. See ISAP/TosohCatalog/TosohCatalogInstructions.
The TosohCatalogue and ISAP will be demonstrated during the training sessions and
special attention will be given regarding available working tools, adjustment tools and
minimum stock items!
18. EVALUATION AND EXAM:

Now that the training is finished we would like to know how you felt about it. Comments
and suggestions are crucial for assessing and improving the quality of this Training
Program. Please take a few moments to give us your honest evaluation of the training.
Following documents to be filled in and handover to instructor:
 Training checklist.
 Training Evaluation.
 Exam.
End of the training AIA360

（ Actuators and active parts）（ Sensor）

Unit Function No. Symbol Actuator Logics (*1) Function No. Symbol Sensor Logics (*2)
1 Turntable Turntable rotation 1 PM101 Two-phase stepping motor CW Table position （ TC) 1 S101 Transmission Position OK
Table position (Home) 2 S102 Transmission Position OK
Sample ID 3 B101 BCR
Sample vessel ID (Up) 4 S103 Transmission （ *３）
Sample vessel ID (Down) 5 S104 Transmission （ *３）
CCD camera lighting 2 LE101 Red LED ON CCD camera 6 C101 CCD camera
TC agitation 3 PM102 Two-phase stepping motor Left-Right B/F stop position detection 7 S105 Transmission Position OK
TC temperature regulation 4 HT101 Seat heater ON Incubator temperature detection 8 T101 Thermistor A/D processing
2 Sample dispensingDispensing
unit syringe drive 5 PM201 Two-phase stepping motor Syringe suction Dispensing syringe home 9 S201 Transmission Home (Up)
Dispensing nozzle Z-axis drive 6 PM202 Two-phase stepping motor Down Dispensing nozzle Z-axis home 10 S202 Transmission Home (Up)
Dispensing nozzle R-axis drive 7 PM203 Two-phase stepping motor Outward Dispensing nozzle R-axis home 11 S203 Transmission Home (Front)
Dispensing nozzle θ-axis drive 8 PM204 Two-phase stepping motor CW Dispensing nozzle θ-axis home 12 S204 Transmission Home (Front)
Surface detection (Sample) 13 S205 Conductive A/D processing
Block detection 14 S206 Pressure sensor
A/D processing
Nozzle washing control valve 9 SV201 Two-way solenoid valve Open
Diluent pump 10 LP201 Liquid pump ON Surface detection (Drain) 15 S207 Electrode Liquid present
W ash solution pump 11 LP202 Liquid pump ON
Diluent port valve 12 SV202 Two-way solenoid valve Open
W ash solution port valve 13 SV203 Two-way solenoid valve Open
Diluent drain valve 14 SV204 Two-way solenoid valve Open
3 Seal breaker Seal breaker Z-axis drive 15 PM301 Two-phase stepping motor Up-Down Seal breaker Z-axis home detection 16 S301 Transmission Home (Up)
Seal break check 17 S302 Transmission Seal break
4 W ashing unit B/F probe (up/down) 16 PM401 Two-phase stepping motor Down B/F probe 1 home position detection 18 S401 Transmission Home (Up)
Overflow detection 19 S402 Electrode Overflow
W ashing syringe drive 17 PM402 Two-phase stepping motor Syringe suction W ashing syringe home detection 20 S403 Transmission Home
W ash solution temperature regulation 18 HT401 Ｃａｒｔｒｉｄｇｅ heater ON Incubator temperature detection 21 T401 Thermistor A/D processing
Vacuum source 19 LP401 Liquid pump ON
B/F discharge control valve 20 SV401 Three-way solenoid valve Syringe→Discharge
B/F discard control valve 21 SV402 Two-way solenoid valve Open
5 Substrate unit Substrate syringe drive 22 PM501 Two-phase stepping motor Syringe suction Syringe pump substrate home detection 22 S501 Transmission Home (Up)
Substrate temperature regulation 23 HT501 Ｃａｒｔｒｉｄｇｅ heater ON Incubator temperature detection 23 T501 Thermistor A/D processing
Substrate discharge control valve 24 SV501 Three-way solenoid valve Syringe→Discharge
6 Detector unit Detector light source LED lighting 25 LE601 Ultraviolet LED ON/OFF Detector data (V/F input)　 Sample 24 V/F
Detector data (V/F input)　 Reference 25 V/F
Detector drive 26 DM601 DC motor Left-Right Detector position (L) 26 S601 Transmission Position OK
Detector position (R) 27 S602 Transmission Position OK
7 Panel
W arning 27 LE701 Red LED ON
App1: Actuators and sensors per module

AIA-360 Signal and Channel Diagram

W ash solution temperature regulation
Heater HT401
V3 Therm istor T401 SV401
Substrate temperature regulation 29 BF syringe drive

PM501 Heater HT501
Substrate Therm istor T501 PM402
PM401 24
S501 S401 S403
Substrate syringe drive
S205
Surface detection
PM101 BF nozzle drive
Pressure sensor
S101 21
S102 S402 V1
SV201
V7
SV402 23
Turntable S201 LP202
⑯ Dispensing nozzle θ-axis Dispensing syringe drive
PM204 S204 PM201 Liquid feed pum p (W ash solution)
Dispensing nozz;e R-axis Seal breaker
PM203 S301 PM301
S203 S302
PM102
Cup reader
S105
Agitator Dispensing nozzle Z-axis 33 W ash
S202 solution
W ashing port
26 ⑰ Diluent port B101

V5
23 ⑱ S207 BCR SV202
V6 S103
Surface
SV204 detection
28 ⑲ 27
overflow line S104
sample detection LP201
22 20 I/O specs
Liquid feed pum p (Diluent)
Incubator temperature regulation 33
DI Diluent
Heater HT101
Therm istor T101
1.5kΩ
W aste bottle
R
W aste pum p
LP401 4.7kΩ 1/2W
ADC
DO
RS-232C
COM
Capture
Board
App2: Flow diagram
(DSC_ 40_ BW

App3: Tubing list

App4: Interconnection diagram



App5: Parameters

Motor Type Current Adjusting Mode

VR median value for Test Pin
PM Axis name A：single shaft setting resistor: （F：Full,H：Half,
adjustment range A TP
B：dual shaft Ioh A VR M：1/8 micro）
PM402 Wash syringe PK244-01A 0.70 0.686 (0.332 to 1.040) 4 1 F
PM102 mixer PK244-01A 0.50 0.686 (0.332 to 1.040) 5 2 H
PM301 seal breaker PK244-01A 1.00 0.786 (0.381 to 1.191) 6 3 F
PM203 sampling R-axis PK233PA 0.80 0.586 (0.284 to 0.889) 7 4 H
PM501 substrate syringe PK244-01A 0.70 0.686 (0.332 to 1.040) 8 5 F
PM202 sampling Z-axis PK244-01B 0.80 0.686 (0.332 to 1.040) 9 6 M
PM201 diluent syringe PK244-01A 0.70 0.686 (0.332 to 1.040) 10 7 F
PM204 sampling theta-axis PK245-01B 0.80 0.686 (0.332 to 1.040) 11 8 M
PM101 turntable PK244-01A 0.50 0.686 (0.332 to 1.040) 12 9 H
PM401 B/F Probe PK244-01A 0.50 0.686 (0.332 to 1.040) 13 10 F
App 6: Motor currents

Annual Inspections
Location Inspection Item Description Corrective Action
1 Table (Carousel) □Cup holder cleaning Wipe the cup contact surface using alcohol.
□Sample holder cleaning Wipe the blood tube and the sample cup contact
surface using alcohol.
□Hot plate cleaning Clean the contact surface of the cup bottom using
alcohol.
□Position check Check the positional relations with units Position adjustment
according to the adjustment procedures.
2 Seal breaker □Punch cleaning Remove the punch and clean the blade
using alcohol.
□Positional deviation check Check the position according to the adjustment Adjust the position with a jig.
procedures. The breaker shall punch a seal Replace the breaker if the blade is dull.
evenly without making printing unclear.
3 Dispensing arm □Metal nozzle cleaning Clean the nozzle using alcohol.
(Nozzle)
□Nozzle tube cleaning Check the suction hole of the nozzle using
a mirror to ensure that the nozzle is clean
and there is no blockage.
□Sample suction position check Check that the nozzle comes to the center at Position adjustment
each position:
・Nozzle washing position
・Cup discharge position
・Sample suction position
□Greasing Grease the Z-axis feed screw. Clean with CRC and apply AFC grease
Grease the R-axis LM guide. Clean with CRC and apply AFC grease
4 Dispensing syringe □Leakage test Attach an end-blocked chip to the nozzle and Tube and joint check
reduce 100 ul for pressure fluctuation check. and syringe replacement
□Greasing Grease the feed screw. Clean with CRC and apply AFC grease
□Suction AD Verify the suction AD before and after syringe seal
replacement
□Seal replacement Replace the seal with a new one. Seal replacement
5 Washing syringe □Greasing Grease the feed screw. Clean with CRC and apply AFC grease
□Seal replacement Replace the teflon seal with a new one. Seal replacement
6 Substrate syringe □Greasing Grease the feed screw. Clean with CRC and apply AFC grease
□Seal replacement Replace the seal with a new one. Seal replacement
7 B/F washing □Washing probe cleaning Remove the probe and eliminate any blockage
or dirt from the probe tip.
□Wash probe tip replacement Replace the teflon tip on the wash nozzle
□Suction check Place the washing probe in a vessel and Check to see that the tubing is not blocked.
prime the wash solution to see that there is Replace the liquid pump
no liquid suction problem. and the washing probe.
□Position check Check that the washing probe lowers to Position adjustment
the center of the cup.
8 Substrate dispenser □Point cleaning Remove the substrate dispenser and clean
the dispenser tip.
9 Detector □Lens cleaning Remove the detector and wipe the lens using
cleaning alcohol (70%).
10 Liquid feed □Filter replacement for diluent and Replace the filter with a new one.
wash solution tanks
□Air purge from wash solution line Replace once with alcohol.
□Substrate line cleaning Clean the substrate line with diluted nitric acid.
□Diluent pump replacement Replace the diluent pump with a new one.
□Wash solution pump replacement Replace the wash solution pump with a new one.
□Waste pump replacement Replace the waste pump with a new one.
11 Temperature check □C heck temperature of main incubator Adjust temperature if not in range
□C heck substrate line incubator Adjust temperature if not in range
□Verify wash solution preheater Adjust temperature if not in range
12 Carousel base plate □C lean the plate around the carousel Look for lost beads
After the above procedures, initialize the system to see that no abnormalities occur.
If a corrective action affects data, perform calibration and control measurement as required.
App7: Tosoh AIA-360 yearly maintenance program

Installation validation protocol AIA(rev 09/2008)

Type: AIA-360 S/N :
1 - Calibrate in triplicate, #TSH and #FT4

( attach the calibration curves)
2 - Verify by means of a QC a sandwich- and a competitive assay.
Test on TSH and FT4, 5 fold, on the 3 levels of the QC.

(Attach the list of results)
The CV's should be inferior to 5%(7% for #FT4 level 1)
QC lor nr.:
TSH FT4
level1 level 2 level3 level1 level2 level 3
1
2
3
4
5
Mean #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!

SD #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
CV #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Test AIA360
App 8: Installation protocol

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AIA360_ServiceTrainingGuide_REV12

Service Training Guide

Software version 1.36S/1.36U

TOSOH EUROPE N.V. Marc Leupe  1

TOSOH EUROPE N.V. Marc Leupe  2

9.5.1.3. What method is used 29

12.6. LEAK SENSOR S702 DETECTED ERROR 3022 64

13.5.2. BF Prime with Hitachi cup 81

TOSOH EUROPE N.V. Marc Leupe  5

TOSOH EUROPE N.V. Marc Leupe  6

 Understand the fluorescent measurement principle in immunology

 Assemble and disassemble an AIA-360 instrument

 Install, adjust and maintain an AIA-360 instrument

 Solve mechanical and electronic problems

 Solve analytical problems

TOSOH EUROPE N.V. Marc Leupe  7

3. AIA MEASUREMENT SEQUENCE:

TOSOH EUROPE N.V. Marc Leupe  8

 No tips are used for sampling

 Sampling with a metal probe

 Level sensing by capacitive differentiation and air detection

 Linear sample volume Clog detection: K1,K2

 No automatic dilutions and pretreatments

 Integrated sample and reagent carousel, no cup transfer arm

 Dichromatic detector with LED light source (same as on all AIA

TOSOH EUROPE N.V. Marc Leupe  9

5. AIA360 SYSTEM CONFIGURATION:

 Location of the different modules: incubator, wash probe, syringes,

 Explanation Signal diagram (see App 2:flow diagram):

 Location different electronic boards:

Power supply Board ADO-PWR-V2

TOSOH EUROPE N.V. Marc Leupe  10

TOSOH EUROPE N.V. Marc Leupe  11

TOSOH EUROPE N.V. Marc Leupe  12

8.1. POWER SUPPLY CONFIGURATION:

5 +15 5 +15 Main PCB for DET

TOSOH EUROPE N.V. Marc Leupe  13

8.2. MAIN BOARD:

ADO-MAIN-V2 NORMAL STATUS: LED 3 AND LED 7 FLASHING

Remark: LED 5, 6 and 8 start flashing when temperature is reached!

ADO-MAIN-V2 ABNORMAL STATUS: LED 3 AND LED 7 ON

TOSOH EUROPE N.V. Marc Leupe  14

8.3. SENS BOARD:

FB2 2.0 +5V PROT 2 2 S102 Turntable home

4 Clogging detection 4 S402 B/F probe overflow

5 +15V Analog circuits 5 +15V Analog circuit

6 Vcc 6 +5V Vcc

7 TMP1 Turntable temp 7 S701 Leakage sensor table

8 TMP2 Wash solution temp 8 S702 Leakage sensor wash

9 TMP3 Substrate heater temp 9 S208 Waste tank full

10 AGND Analog ground 10 S405 Wash solution tank ok

11 -15V Analog circuit 11 S404 Diluent tank ok

8.4. DRIVER BOARD:

TOSOH EUROPE N.V. Marc Leupe  15

3-4 Closed Half step 2 +5V 2 +24V For drive applications

8.5. DETECTOR BOARD:

TOSOH EUROPE N.V. Marc Leupe  16

PROCEDURE TO ADJUST DETECTOR POSITION AFTER DISASSEMBLY:

Both flag and flag slit must be at the sensor

PROCEDURE TO ADJUST TURNTABLE HOME POSITION:

TOSOH EUROPE N.V. Marc Leupe  18

9.1.2. Wash probe adjustment X, Y and Z: