GENOMICA Autoclart Plus User manual

autoclart® plus User Manual Version 3, February 2017
1
USER MANUAL
autoclart®plus –User Manual

autoclart® plus User Manual Version 3, February 2017
2
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

autoclart® plus User Manual Version 3, February 2017
3
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

autoclart® plus User Manual Version 3, February 2017
4
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

autoclart® plus User Manual Version 3, February 2017
5
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

autoclart® plus User Manual Version 3, February 2017
6
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.

autoclart® plus User Manual Version 3, February 2017
7
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.

autoclart® plus User Manual Version 3, February 2017
8
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.

autoclart® plus User Manual Version 3, February 2017
9
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

autoclart® plus User Manual Version 3, February 2017
10
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.