GENOMICA Autoclart Plus User manual

autoclart® plus User Manual Version 3, February 2017
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USER MANUAL
autoclart®plus –User Manual

autoclart® plus User Manual Version 3, February 2017
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autoclart® plus
CLART, CLART-Strip and SAICLART are brands registered by GENOMICA.
For greater detail in relation to the information set forth in this manual please access the
following website: www.genomica.com
GENOMICA, S.A.U.
Parque Empresarial Alvento, Edificio B
Calle Vía de los Poblados, 1 –1ª planta
28033 Madrid, Spain
www.genomica.com
Version 3
February 2017

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1. TABLE OF CONTENTS
1. TABLE OF CONTENTS...................................................................................................3
2. PRINCIPLE OF THE ASSAY.............................................................................................6
3. INTENDED PURPOSE ...................................................................................................8
4. USE ...........................................................................................................................8
5. CLASSIFICATION...........................................................................................................9
6. PRODUCT TRADE NAME AND REFERENCES .....................................................................9
7. DESCRIPTION.............................................................................................................10
8. COMPONENTS / CONSUMABLES..................................................................................11
8.1 COMPONENTS...................................................................................................11
8.2 CONSUMABLES..................................................................................................12
9. ACCESSORIES.............................................................................................................13
10. CHARACTERISTICS. ...................................................................................................15
11. UNPACKING, STORAGE AND PACKING. .......................................................................16
11.1. UNPACKING. ...................................................................................................16
11.2. STORING THE PACKAGING. ...............................................................................18
11.3. STORING THE EQUIPMENT................................................................................18
11.4. TRANSFER / TRANSPORTATION. ........................................................................18
11.5. PACKING.........................................................................................................19
12.ENVIRONMENTAL CONDITIONS..................................................................................19
12.1. VENTILATION. .................................................................................................19
12.2 - ENVIRONMENTAL CONDITIONS. ........................................................................19

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13.PRECAUTIONS OF USE ...............................................................................................21
14.PREPARATION OF THE FACILITY PRIOR TO INSTALLATION ..............................................23
15.INSTALLATION..........................................................................................................24
16.TURNING THE EQUIPMENT ON AND OFF .....................................................................26
16.1. ON .................................................................................................................26
16.2. OFF ................................................................................................................27
17.START OF THE ANALYSIS ............................................................................................28
17.1. ENTRY OF THE TYPE OF ASSAY...........................................................................30
17.2. ENTRY OF THE SAMPLE REFERENCES..................................................................31
17.3. WORK LIST......................................................................................................33
17.4. ANALYSIS SETTINGS. ........................................................................................34
18.ANALYSIS ADDING THE SAMPLE AUTOMATICALLY ........................................................34
19.ANALYSIS ADDING THE SAMPLE MANUALLY ................................................................43
20.READING ONLY ANALYSIS ..........................................................................................45
21.READING .................................................................................................................45
22.RESULTS ..................................................................................................................46
23. REANALYSIS OF THE SAMPLE.....................................................................................50
24. MAIN MENU RECORDS .............................................................................................53
22.1. SEARCH BY RUN...............................................................................................53
22.2. SEARCH BY SAMPLE. ........................................................................................55
25. MAIN MENU SETTINGS .............................................................................................55
22.3. INSTALLING / UPDATING A PROGRAM................................................................56
22.4. SYSTEM ..........................................................................................................57

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22.5. BACK-UP / EXPORT ..........................................................................................58
22.6. SERVICE..........................................................................................................59
DECONTAMINATION PROGRAM.........................................................................................60
CLEANING PROGRAM..........................................................................................................61
26. MAINTENANCE / CALIBRATION..................................................................................62
27. CLEANING ...............................................................................................................62
28. CARING FOR THE EQUIPMENT AFTER USE...................................................................64
29. FAQ........................................................................................................................65
29.1 UPDATING AND INSTALLATION OF SOFTWARE......................................................65
30. TECHNICAL ASSISTANCE SERVICE ...............................................................................66
APPENDIX A. TABLE OF FREQUENT ERRORS AND RESPECTIVE SOLUTIONS ...........................67
APPENDIX B. DECLARATION OF CE CONFORMITY ..............................................................70
Declaration of CE Conformity......................................................................................70
APPENDIX C. ABBREVIATIONS USED ................................................................................71
APPENDIX D. WARNING SYMBOLS AND SIGNS. .................................................................72
APPENDIX E. DECONTAMINATION CERTIFICATE. ...............................................................74

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2. PRINCIPLE OF THE ASSAY
autoclart® plus has been developed for the automation of both viewing and reading and
interpreting the results of the in vitro diagnostic kit manufactured by GENOMICA.
The technique is based on:
1. The viewing of a specific reaction through the precipitation of an insoluble
product in microarray areas in which the amplified products have undergone
hybridization.
2. The capacity to associate the tip pattern generated in the array with a specific
diagnostic. This is conducted using an image capturing and processing system and a
specific algorithm for each kit. The technique is based on a system designed to
capture and process the images obtained in the microarray, which will result in the
automatic generation of a single report for each sample analysed. The algorithms used
in each kit are comprehensively validated during the process involving the evaluation of
the performance of the product.
The results obtained by CAR® are automatically displayed on the touch screen and can
be printed out or exported to the LIMS system or a memory unit using the USB
connection.
The image capture device includes a LED light source, a diffusor (to homogenize the
light) and a CCD camera to capture the image.

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Furthermore, the device is equipped with an automatic positioning system to ensure the
plate is in the correct place.
The analysis of the microarray image is conducted using the SAICLART® software
developed by GENOMICA for the interpretation of microarrays. The analysis of the
image is fully automatic, preventing subjectivity and the interaction of the user, thereby
ensuring accurate results in a rapid and repeatable manner.
Compared to classic microarray systems, this system significantly simplifies the
hybridization and viewing processes, allowing for the simultaneous detection of multiple
molecular markers for diagnostic use, while providing the controls required to
guarantee the reliability of the results.

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3. INTENDED PURPOSE
The equipment will be used exclusively by personnel from accredited laboratories and
using GENOMICA S.A.U. in vitro diagnostic kits, illustrated on the website
www.genomica.com
Any use other than that specified may undermine the performance of the equipment.
4. USE
IN VITRO DIAGNOSTIC HEALTH PRODUCT
autoclart® plus is for exclusive use with the reagents supplied by
GENOMICA.
Follow the instructions carefully. We suggest you read these instructions
before putting them aside. They contain useful information on the correct
and efficient management of the equipment.
This apparatus should not be used by people without the appropriate
experience or knowledge, unless under the surveillance of someone
responsible for their safety or who has been given instructions on the use
of the apparatus.
GENOMICA provides a 1 year warranty on this equipment provided that
the use of the autoclart® plus is as indicated in this manual. Improper or
off-spec use will result in the loss of the warranty.

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5. CLASSIFICATION
autoclart® plus complies with the provisions of Council Directive 98/79 / CE on in vitro
diagnostic health products, in accordance with Spanish law pursuant to Royal Decree
1662/2000 of 29 September 2000, and is classified under “other products” in Appendix
III of the Directive.
Moreover, GENOMICA S.A.U. declares that the autoclart® plus equipment has been
manufactured in accordance with the following safety and quality standards and
requirements in force (EN ISO 13485, EN 61010-2-101 and EN 61326-2-6).
6. PRODUCT TRADE NAME AND REFERENCES
autoclart® plus
Reference: ACP

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7. DESCRIPTION
Figure 1. autoclart® plus.
autoclart® plus is a fully automated system for processing plate format assays.
The tool is designed for processing the sample, the addition of reagents, the removal of
liquids, heating, cooling, agitating the incubation plate and scanning the plate at the end
of the assay.
As such, it is equipped with a Peltier system capable of maintaining precise control over
the temperature during the assay, an incubation agitation system and a system to
transfer the plate to the core of the equipment where the camera for capturing images
and analysis is located.
autoclart® plus features an X/Y/Z axis mechanism for adding and removing samples and
reagents. It also features a system for disposable tips, as well as an independent 4-
needle reagent suction system connected to a peristaltic pump.
The control of volumes during the addition of samples is conducted by piston pumps
driven by “micro-step” type motors controlled by software.

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The autoclart® plus is equipped with a computer which operates by means of a touch
screen and an interface designed specifically for the equipment.
The user can use the touch screen to view the number of samples and the assay to be
executed, whereby it is possible to process a minimum of 4 and a maximum of 96
samples per assay.
The equipment will conduct the analysis, reading and the interpretation of the results
automatically.
8. COMPONENTS / CONSUMABLES
8.1 COMPONENTS
The different components of autoclart® plus are illustrated in the diagram below:
Figure 2. Components of autoclart® plus.

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The instructions for the assembly of the different components of the equipment are set
forth in the table below.
Remember that most of the components need to be placed in a specific position.
8.2 CONSUMABLES.
1.
Distilled water bottle
holder
Place the holder on the markers in the position
marked 1.
Remember it will only fit in one position.
2.
Distilled water bottle
Screw on the cap. Place the bottle in the holder in
the position marked 2. Connect the tube from the
piston pumps to the top of the bottle.
3.
Tip rack holder
Place the holder on the markers in the position
marked 3.
4.
TL trough
Place the TL trough on the markers in the position
marked 4.
5.
SH trough
Place the SH trough on the markers in the position
marked 5.
6.
CJ and RE troughs
Place both troughs on the markers in the position
marked 6. The troughs are labeled and only fit in
one position.
7.
Liquid waste trough
Place the trough on the markers in the position
marked 7. Connect the tube from the peristaltic
pump.
8.
Tip waste trough
Place the trough on the markers in the position
marked 8.

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Disposable tips will need to be used in addition to the GENOMICA diagnostic kit.
The equipment has been designed to be used with a specific disposable tip model.
Please contact our local distributor for more information.
Do not attempt to use any other type of tip. This may cause the equipment to
malfunction or result in a breakdown which is not covered by the guarantee.
9. ACCESSORIES.
The equipment comes with the following accessories.
ACCESSORY 1: SOFTWARE.
The analysis of the images and the interpretation of the results are conducted by
specific software for each kit, designed and implemented by GENOMICA.
GENOMICA distributes this software to its clients in accordance with the diagnostic kits
it provides.
Take particular care to ensure the USB device used both for updating software
and exporting data is not infected with a virus. GENOMICA will not be held liable
for removing a virus which has infected the system as a result of improper use
by the user.
In the event the user selects the wrong software, an error message appears
in the results report. Please review the analysis you wish to conduct and
select the correct software.

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ACCESSORY 2: A/C POWER CABLE.
Used to connect the equipment to the power mains with a plug.
autoclart® plus has been designed for use with GENOMICA diagnostic kits, and ,
as such, no other type of tube, vial or material should be used. The use of
autoclart® plus in a manner other than that specified in this manual will result
in the loss of the guarantee provided.
Do NOT use any accessory which has not been supplied by GENOMICA.
GENOMICA will not be held liable for the use of materials not supplied
by the manufacturer.
All the accessories required for the correct use of the equipment will be
supplied by the manufacturer.
In the event any of these components is missing or damaged, please
contact GENOMICA or a sales representative immediately.

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10. CHARACTERISTICS.
Type of instrument
Table equipment
Processing capacity
4 to 96 samples per assay
Processing time
Normally less than 3 hours for 96 samples
Temperature control.
PID control
Processing volume
3 L to 100 L
Dispensing and tolerance system
Piston pumps:
3-10 µL ±10%
100 µL +0% / -5%
Software
Integrated software
Network voltage and frequency
100 to 240 VAC with 5A grounding
50/60 Hz
Fuses
5A UL Approved –Ø5x20 mm - T5AL250VAC
Dimensions
620(H) x 650(D) x 800(W) mm / (W = 1150 mm with the screen)
Weight
80 kg
Power
500 W (max)
Noise level (dB)
~ 60 dB
Electromagnetic compatibility
Classes A 30 MHz to 1000 MHz

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Electromagnetic susceptibility
10 V/m 80 MHz to 1000 MHz
3V/m 1.4 GHz to 2 GHz
1V/m 2 GHz to 2.7 GHz
UV lamp
T8 15W UVC G13 (GEMICIDA)
11. UNPACKING, STORAGE AND PACKING.
We suggest you read the entire manual before unpacking and installing the equipment
or using it. Pay attention to all the hazard alerts and warnings. Failure to do so may
result in serious injury to the user or damage to the equipment. In order to ensure the
protection this equipment provides is not damaged, do not use or install it in a manner
other than that specified in this manual.
11.1. UNPACKING.
BEWARE, HEAVY EQUIPMENT!
At least 2 persons are required to move the equipment. The packed equipment
weighs around 110 kg.
The use of gloves is recommended when handling the equipment as some of
the components of the container may have sharp edges.
On receiving the equipment check the packaging is not damaged; if it is, please notify
GENOMICA immediately.

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Follow the steps below to open the packaging:
1. Place the box in a vertical position to open it.
2. Open the box and remove the user manual; continue in accordance with the
instructions set forth in the manual.
3. Remove the flaps and the lid.
4. Pull off the outer wooden cover and remove the protective bubble paper.
5. Lift the equipment to one side and remove the side foam at the same time. Repeat
this procedure on both sides.
6. Two persons are required to take the equipment out of the container, one in front
of it and one behind it.
7. Inspect the equipment to check for any clear signs of damage during
transportation. Report any damage to your local representative immediately.
8. Check the serial number and the number on the delivery note match.
9. Open the door to the equipment and remove the box of accessories from inside.
Para in order to prevent any kind of damage to autoclart® during delivery, the
internal mobile components are held in place using fastening systems
which need to be removed prior to use.
autoclart® plus features a safety screw to protect the optical system from
damage while being transported. This screw must be removed prior to
using autoclart® plus.

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11.2. STORING THE PACKAGING.
Fold the wooden box in order to store the packaging correctly.
Keep the original packaging materials!
Equipment returned for repair should be dispatched in the
original packaging material in order to protect it from damage
during transportation.
11.3. STORING THE EQUIPMENT.
If the equipment is temporarily stored on the ground or an uneven surface, the
appropriate measures should be taken to protect it.
The equipment features delicate components which operate in a vertical position, and
care should be taken not to twist the structure of the equipment while it is being stored.
This manual should be kept close at hand for everyday
reference!
In the event of transfer, ensure the manual is kept together with
the equipment to provide the new owner with the instructions
of use and the respective warnings.
11.4. TRANSFER / TRANSPORTATION.
In the event the equipment needs to be transported after use in the laboratory, it will
need to be cleaned and decontaminated. Moreover, a certificate of decontamination
should be issued.
In the event the equipment needs to be moved to another location, it should be lifted
and transported. It should never be pushed or dragged.

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11.5. PACKING.
The safety screw and the three new fastening straps must be in place when transporting
the equipment. Follow the respective instructions below:
1. Turn off the equipment completely.
2. Unplug the equipment from all power sources.
3. Place the safety screw in its housing located on the lower right-hand side in the
rear of the working area and screw it in.
4. Move the robot arm fully to the left and put the safety straps in place.
12. ENVIRONMENTAL CONDITIONS
12.1. VENTILATION.
Take the following recommendations into account:
Do not place the equipment in areas in which there are currents of air.
Moreover, the equipment does not require specific ventilation.
Place the equipment at least 100 mm away from walls and equipment.
12.2 - ENVIRONMENTAL CONDITIONS.
Take the following recommendations into account:
The equipment is for exclusive use indoors and should not be exposed to major
variations in temperature and humidity. It has been designed for use in normal
laboratory conditions.
Keep the equipment away from dust, solvents and acidic vapours.
Avoid vibrations and direct sunlight to ensure accurate results.

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Altitude
Up to 2000 m.
Temperature
Ambient temperature: 18 °C –24 °C.
Humidity
Maximum relative humidity of 80% for temperatures of up to 31 °C
decreasing linearly to around 50% for 40 °C.
Network voltage
100 to 240 VAC –5A 50/60 Hz with variations of up to ± 10 %.
Transport and
storage conditions
From 5 °C to 50 °C.
Once the equipment has been assembled wait for 1 hour before turning it
on to avoid potential problems caused by condensation. All waste liquid is
stored in the equipment until the end of the test, and, as such, it does not
need to be drained.
Do not use this equipment in the vicinity of powerful electromagnetic
radiation as this may affect its performance.
The user is responsible for guaranteeing an electromagnetic environment
which is compatible with the equipment to ensure the device operates
correctly.
When working in a magnetic environment the user should check the device
is performing correctly prior to routine use.