A I. Technical Specifications: Please Note

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A I.

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

GENERAL SPECIFICATIONS

Automatic random and continual access analyzer aimed at giving results per patient, with direct photometric reading over
a reactions rotor.

Preparation cycle time 24 s (up to 150 prep/h)


Warm-up time 25 mins
Reading time for each preparation Every 24 s, up to 10 mins
Dimensions 840 x 670 x 615 mm (33.1"x26.8"x24.2")
(length x depth x height)
Weight 45 kg (100lb)

REAGENTS AND SAMPLES TRAY

Positions for racks 4


Capacity of the sample racks 24
Maximum number of samples 72
ø13 mm, ø15 mm sample tubes (max. height 100 mm), ø13 mm paediatric well
Capacity of the reagent racks 10
Maximum number of reagents 30
20 ml and 50 ml reagent bottles
Possible configurations

Sample racks Reagent racks Number of samples Number of reagents


1 3 24 30
2 2 48 20
3 1 72 10

DISPENSING SYSTEM

NEEDLE

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

NEEDLE THERMOSTATATION SYSTEM

Actuator Resistive elements


Control PID
Thermostatation time < 15 s
Dispensation temperature 37°C
Trueness ± 0.5°C
Repeatability ± 0.5°C

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DISPENSING PUMP

Ceramic piston with PTFE-graphite seal


Piston diameter 8 mm
Displacement 25 mm
Dispensing volume 3 µL - 1250 µL
Resolution 0.126 µL
Fuzziness <1% up to 3 µL
Dispensing speed max. 880 µL/s
Programmable reagent volume 10 µL -440 µL
Programmable sample volume 3 µL - 40 µL

NEEDLE WASHING SYSTEM

System liquid consumption approx. 2.4 ml per preparation


System liquid container volume 3000 ml
Waste container volume 3000 ml
Capacitance waste and water level control

REACTIONS ROTOR AND READING

WELL ROTOR

Semi-disposable extractable methacrylate rotor


Number of wells 120
Accepted reaction volumes 200 µL - 800 µL
Light path length 6 mm

ROTOR THERMOSTATATION SYSTEM

Actuators 4 Peltier cells


Control PID
Working temperature 37°C
Trueness ± 0.2°C
Stability ± 0.1°C

OPTICAL SYSTEM

Halogen lamp 6 V, 10 W
Wavelength selection with compensated interferential filters
Detection system with silicon photodiode and 20-bit AD integrator-converter
Measurement range from -0.05 A to 2.5 A
Reading speed 1.25 readings/s
Maximum number of filters 9
Base configuration of the filter drum 340, 405, 505, 535, 560, 600, 635, 670 nm
Wavelength precision ± 2 nm
Bandwidth 10 ± 2 nm
Digital resolution < 0.0001 A
Base line stability max. 0.004 A in 30 mins, at 505 nm
Repeatability of the reading system ± 0.0005 A to 0.1 A (CV = 0.5%)
(1 SD, 505 nm, with filter movement) ± 0.0003 A to 1.0 A (CV = 0.3 %)
± 0.0005 A to 2.5 A (CV = 0.2 %)
Optical repeatability between wells ± 0.003 A at 340 nm
± 0.002 A to 505 nm, 670 nm
Precision ± 0.005 A to 0.1 A (± 5%)
± 0.015 A to 0.5 A (± 3%)
± 0.02 A to 1.0 A (± 2%)
± 0.04 A to 2.0 A (± 2%)
± 0.05 A to 2.5 A (± 5%) at 340 nm, 405 nm, 505 nm

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MINIMUM COMPUTER REQUIREMENTS

Pentium IV processor or higher


Windows 98 or higher
256 Mb RAM
50 Mb free hard disk space
CD-ROM
VGA Monitor, minimum resolution of 640x480
Mouse
RS-232 serial channel or USB connector
The insulation level of the communications channel of the A15 analyzer is reinforced (the insulation of the communications
channel of the computer must also be reinforced)(1)

POWER REQUIREMENTS

Input voltage 125-230 Vac, 50/60 Hz


Power 150 VA
Electrical installation category (overvoltage category) II
The power point must be officially approved, earthed and the cable must have a minimum cross-section of 1.5 mm2.

ATMOSPHERIC CONDITIONS

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

(1)
Reinforced insulation is that which ensures protection equal to or higher than double that provided by the main
insulation.
The main insulation is that whose failure could lead to a risk of electric shock (EN 61010-1).

COMPLIANCE WITH DIRECTIVES AND APPLIED STANDARDS

Directive 98/79/CEE regarding sanitary products for in vitro diagnostic use


• EN 61010-2 -10:2002 “Safety requirements for electrical equipment for measurement, control and laboratory use. :
EN61010-2-101:2004»Particular requirements for vitro diagnostics(IVD) medical equipment”
• UNE EN 61326:1999+A1:2000+A2:2003+A3:2005+ERR:2002 “Electromagnetic equipment for measurement, control
and laboratory use –ECM requirements.
• UNE-EN 55022:2000+A1:2002+CORR:2002- Radiated emissions class B-continuous interference class B”.
• UNE -EN 61000-3-2:2002 «Harmonic current»
• UNE -EN 61000-3-3:1997+Corr:1999+A1:2002-»Flickers»
• UNE -EN 61000-4-2:1997+A1:1999+A2:2001
• UNE -EN 61000-4-3:2003+A1:2004-»Radiated immunity»
• UNE -EN 61000-4-4:1997+A1:2001+A2:2002-»Fast transient /Burst»
• UNE -EN 61000-4-5:1997+A1:2001-»Surge transients»
• UNE -EN 61000-4-6:1998+A1:2001-»Conducted immunity»
• UNE -EN 61000-4-11:1997+A1:2001-»Voltage disp short interruptions and voltage variations immunity»
• UNE EN 22233-02. Test packaging.
• UNE EN 24180-2.Complete and full shipment packaging.
• UNE EN 22247-03(ISO 2247-2000). Fixed low frequency vibration test.
• UNE EN 22248-94. Freefall vertical shock test.

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MAXIMUM SIZE OF ANALYZER

With the lid closed: Width: 840 mm. Depth: 670 mm. Height: 615 mm.
With the lid open: Width: 840 mm. Depth: 670 mm. Height: 1,025 mm.

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

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A II. ADJUSTMENT MARGINS TABLES
Main voltage measurement points Level detection sensitivity
CIIM0015 Power supply board Paediatric rack [15,60]
TP1 - 6V [5.6-5.8] V 13/15mm tube sample rack [15,60]
Reagent rack [9,35]
TP2 - 12V [11.7 -11.9] V
Positioning of the dispensing point
TP3 - 5V [4.9-5.2] V
Dispensing rotor [90,120]
Sp150 [23.5-24.5] V
Fine rotor X [35,200]
Needle thermostatation
CIIM0026 Microprocessor board Set point temperature [35,41]
TP60 - Vref motor Z [13 -15] mV Rotor thermostatation
TP61 - Vref motor Y [13 -15] mV Set point temperature [36,37.5]
TP56 - Vref motor X [13 -15] mV Filter drum positioning
TP57 - Vref pump motor [13 -15] mV Positioning [-5,5]
TP58 - Vref filter motor [13 -15] mV
Positioning of rotor in optic
TP59 - Vref rotor motor [13 -15] mV Positioning [-15,0]
Integration times
Main adjustment values of the analyzer F1 340 nm [190,350]
F2 405 nm [40,130]
Tolerances F3 505 nm [40,130]
Operating arm positioning F4 535 nm [40,130]
X axis loss of steps F5 560 nm [40,130]
Loss of steps [-3,3] F6 600 nm [40,130]
Y axis loss of steps F7 635 nm [40,130]
Loss of steps [-3,3] F8 670 nm [50,130]
Z axis loss of steps Number of counts
Loss of steps [-3,3] F1 340 nm [750000,970000]
Loss of steps rotor motor F2 405 nm [840000,970000]
Loss of steps [-3,3] F3 505 nm [840000,970000]
Loss of steps filter drum motor F8 670 nm [840000,970000]
Loss of steps [-3,3] Darkness counts
Loss of steps pump motor F1 340 nm [3700,4300]
Loss of steps [-4,4] F2 405 nm [3700,4300]
XY position adjustment F3 505 nm [3700,4300]
X origin [10,125] F8 670 nm [3700,4300]
Y origin [240,290] SMF repeatability (Noise)
X racks tray [620,750] Dev. Est. NC. F0 Covered ≤ 55
Y racks tray [-20,20] Dev. Est. Abs. F1 340 nm ≤ 0.0004
X washing station [330,450] Dev. Est. Abs. F2 405 nm ≤ 0.0006
Y washing station [70,120] Dev. Est. Abs. F3 505 nm ≤ 0.0004
X rotor [60,170] Dev. Est. Abs. F8 670 nm ≤ 0.0007
Y rotor [1030,1060] Stability at 505 nm
Maximum Z [1090,1155] Dev. Est. Abs. F3 505 nm ≤ 0.0008
Self-centering of needle Max. NC [840000,970000]
X Offset [-4,4] Min. NC [840000,970000]
Y Offset [-4,4] Max NC / Min NC ≤ 1,006
Bottle level control sensitivity Repeatability MF (Repeatability)
Water empty [200,255] Dev. Est. Abs. F1 340 nm ≤ 0.0008
Water full [30,120] Dev. Est. Abs. F2 405 nm ≤ 0.0006
Water calculated [85,160] Dev. Est. Abs. F3 505 nm ≤ 0.0005
Waste empty [200,255] Dev. Est. Abs. F4 535 nm ≤ 0.0005
Waste full [25,140] Dev. Est. Abs. F5 560 nm ≤ 0.0005
Waste calculated [90,175] Dev. Est. Abs. F6 600 nm ≤ 0.0005
Dev. Est. Abs. F7 635 nm ≤ 0.0005
Dev. Est. Abs. F8 670 nm ≤ 0.0005

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A III. LIST OF CONSUMABLES, ACCESSORIES AND


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

CODE DESCRIPTION (Ordered by code) CODE DESCRIPTION (Ordered by description)


CA10455 European network cable AC11502 13 mm tube sample rack
CA10456 American network cable AC11503 15 mm tube sample rack
FI10466 Serial channel cable for connection to PC AC12223 2 mm Allen key
AC10770 Sample wells (1000),Paediatric reaction wells BO11494 20 ml bottle with top (10 units)
AC11485 Reaction rotor (10 units) AC11501 20 ml/50 ml reagents rack
AC11486 Reactions rotor fastening screw FI11563 340 nm filter unit
FI11490 535 nm filter unit FI11564 405 nm filter unit
FI11491 560 nm filter unit BO11493 50 ml bottle with top (10 units)
BO1149 350 ml bottle with top (10 units) FI11565 505 nm filter unit
BO1149 420 ml bottle with top (10 units) FI11490 535 nm filter unit
FI11498 Covered filter unit FI11491 560 nm filter unit
AC11501 20 ml/50 ml reagents rack LA13195 6 V/10 W halogen lamp
AC11502 13 mm tube sample rack FI11566 600 nm filter unit
AC11503 15 mm tube sample rack FI11567 635 nm filter unit
AC11504 Paediatric well samples rack FI11568 670 nm filter unit
BO11524 Bottle of concentrated system liquid (1L) CA10456 American network cable
FI11563 340 nm filter unit BO11524 Bottle of concentrated system liquid (1L)
FI11564 405 nm filter unit BO13146 Concentrated washing solution (100mL)
FI11565 505 nm filter unit FI11498 Covered filter unit
FI11566 600 nm filter unit AC13193 Detachable needle
FI11567 635 nm filter unit CA10455 European network cable
FI11568 670 nm filter unit AC13200 Filter drum cover
AC12222 Metal rod for cleaning the needle AC13199 Height-adjustable leg
AC12223 2 mm Allen key ZO13196 Lamp holder fastening system
BO13146 Concentrated washing solution (100mL) AC12222 Metal rod for cleaning the needle
AC13188 User programme CD AC13198 Operating arm fastening for transport (screw
BO13189 System liquid container with top and foam)
FI13190 System liquid container filters AC11504 Paediatric well samples rack
BO13191 Washing solution container with top AC11485 Reaction rotor (10 units)
BO13192 Waste container with lid and fitting AC13197 Reactions rotor cover
AC13193 Detachable needle AC11486 Reactions rotor fastening screw
FU13194 Set of 2 A (F) fuses AC10770 Sample wells (1000), Paediatric reaction wells
LA13195 6 V/10 W halogen lamp FI10466 Serial channel cable for connection to PC
ZO13196 Lamp holder fastening system FU13194 Set of 2 A (F) fuses
AC13197 Reactions rotor cover FI13190 System liquid container filters
AC13198 Operating arm fastening for transport (screw BO13189 System liquid container with top
and foam) User Manual/Installation and maintenance
AC13199 Height-adjustable leg manual
AC13200 Filter drum cover AC13188 User programme CD
User Manual/Installation and maintenance BO13191 Washing solution container with top
manual BO13192 Waste container with lid and fitting

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List of spares exclusive to the technical support service.

CODE DESCRIPTION (Ordered by code) CODE DESCRIPTION (Ordered by description)


CA13308 CD-ROM with Service programme and Service MO13358 A15 fan
manual AC13365 Arm hose
VA10355 Mains connector CA13393 Base cover
ZO10407 Fuse holder CA13379 Bottom cover of needle set
IN11557 Mains switch PC13384 Communications board
FO11570 Set of five photosensors TU13366 Container tube unit
AC11860 Temperature adjustment tool AC13362 Dispensing pump fluid chamber
AC13350 Full operating arm MO13363 Dispensing pump motor
MO13351 X guide motor AC13361 Dispensing pump seal
ME13352 Y carriage belt ME13364 Electrovalve
MO13353 Y guidemotor AC13375 Filter wheel body
MO13354 Z guide motor MO13376 Filter wheel motor
ME13355 Spring set PC13382 Front indicator
AC13356 Full thermostated needle set CA13395 Front al cover
MO13357 Peltier fan AC13356 Full thermostated needle set
MO13358 A15 fan ME13359 Full dispensing pump
ME13359 Full dispensing pump AC13350 Full operating arm
AC13360 Thermostated needle fastening nut AC13370 Full reactions rotor
AC13361 Dispensing pump seal ZO10407 Fuse holder
AC13362 Dispensing pump fluid chamber ME13377 Hydro-pneumatic cylinder of the cover hinge
MO13363 Dispensing pump motor CA13397 Instrument cover
ME13364 Electrovalve ZO13374 Lamp holder
AC13365 Arm hose TR13389 Main power supply
TU13366 Container tube unit VA10355 Mains connector
ME13367 Waste pump IN11557 Mains switch
TU13368 PVC waste tube PC13380 Microprocessor board
AC13369 Waste container nut and cap MO13357 Peltier fan
AC13370 Full reactions rotor CE13388 Peltier cell
AC13371 Rotor temperature sensor PC13381 Photometric system board
MO13372 Rotor motor PC13383 Power supply board
AC13373 Rotor cover sensor PC13387 Pumps interconnection board
ZO13374 Lamp holder TU13368 PVC waste tube
AC13375 Filter wheel body AC13373 Rotor cover sensor
MO13376 Filter wheel motor PC13386 Rotor interconnection board
ME13377 Hydro-pneumatic cylinder of the cover hinge MO13372 Rotor motor
CA13378 Upper cover of needle set AC13371 Rotor temperature sensor
CA13379 Bottom cover of needle set CA13308 CD-ROM with Service programme and Service
PC13380 Microprocessor board manual
PC13381 Photometric system board FO11570 Set of five photosensors
PC13382 Front indicator CA13396 Spring protection cover
PC13383 Power supply board ME13355 Spring set
PC13384 Communications board AC11860 Temperature adjustment tool
PC13385 XYZ interconnection board AC13360 Thermostated needle fastening nut
PC13386 Rotor interconnection board CA13394 Upper cover
PC13387 Pumps interconnection board CA13378 Upper cover of needle set
CE13388 Peltier cell AC13369 Waste container nut and cap
TR13389 Main power supply ME13367 Waste pump
CA13393 Base cover MO13351 X guide motor
CA13394 Upper cover PC13385 XYZ interconnection board
CA13395 Front al cover ME13352 Y carriage belt
CA13396 Spring protection cover MO13353 Y guidemotor
CA13397 Instrument cover MO13354 Z guide motor

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A IV. LIST OF REQUIRED TOOLS


1. Set of metric Allen keys.
2. Loctite 243 screwfastener or similar
3. Mechanical grease ELESA NT1 (for ceramic pump only) (AC13079).
4. Heat silicone or similar
5. Soldering iron
6. Screwdrivers or two 3 mm Allen keys.
7. Loctite 245 or similar (for ceramic pump only).
8. Temperature adjustment tool (AC11860).

Temperature adjustment tool

A V. SOFTWARE VERSIONS
Change in the versions of service program
Date version Change
04/04/06 3.0.1 First release version
20/07/06 3.0.2 Correction of errors
Improve the checking before load a new firmware
18/12/06 3.1.0 Modify the level sensitivity adjustment screen to incorporate the
independent adjustment by type of rack.
Added the help menu with the preventive maintenance guide.

Change in the versions of user program


Date version Changes
04/04/06 3.2.1 First release version
20/07/06 3.2.2 New button in the tools menu, reset the historical base line
Fix the options of the initial and final wash. Delete the menu to
choose the parameter of initial and final wash. Add a maintenance
guide in the help menu.
14/11/06 3.3.0 Improve and optimitation of the execution times of the application.
Corrected the application errors that showed the message «not
respond»

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Change in the versions of firmware
Date version Change
04/04/06 2.90 First release version
09/05/06 2.92 Improvements in the generation of the pattern of encoder
18/12/06 3.0 In order to avoid the splashes in the dispensation of the predilution,
the dispensation speed have been reduced.
The sensitivity adjustment have been split in 3 diferents
adjustments, one for each type of rack.

Compatibilities table
User A25 3.2.1 3.2.2 3.3.0
firmware
2.90 x x x
2.92 x x x
3.0 x x x

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

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BIOSYSTEMS, S.A. Costa Brava, 30, 08030 Barcelona - Spain Tel: 34-93 311 08 11 Fax: 34-93 346 77 99
e-mail:biosystems @biosystems.es http://www.biosystems-sa.com
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