GENOMICA CAR User manual

User manual Version 8 July 2015
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CLINICAL ARRAY READER
(CAR®)
USER MANUAL

User manual Version 8 July 2015
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CAR® (CLINICAL ARRAY READER)
CAR, CLART, CLART-Strip, SAICLART, ENTHERPEX, ENTEROBAC, PNEUMOVIR, PNEUMO
CLART BACTERIA and SEPTIBAC are registered Trademar s of GENOMICA.
For more information, please refer to the web site www.genomica.com
GENOMICA, S.A.U.
arque Empresarial Alvento, Edificio B
Calle Vía de los oblados, 1 – 1ª planta
28033 Madrid, Spain
www.genomica.com
Version 8
July 2015

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1.TABLE OF CONTENTS
1. TABLE OF CONTENTS...................................................................................................3
2. RINCI LE OF O ERATION OF THE DEVICE ......................................................................5
3. INTENDED USED ..........................................................................................................8
4. USE: .........................................................................................................................10
5. CLASSIFICATION ........................................................................................................10
6. TRADING NAME OF THE RODUCT AND REFERENCES ....................................................11
7. COM ONENTS...........................................................................................................11
9. S ECIFICATIONS.........................................................................................................13
10. UN ACKING, STORAGE AND ACKING. .......................................................................15
11. ENVIRONMENTAL CONDITIONS .................................................................................17
12. USAGE RECAUTIONS...............................................................................................18
13. MAINTENANCE ........................................................................................................20
14. CLEANING ...............................................................................................................20
15. CARING FOR THE DEVICE AFTER USE ..........................................................................21
16. RE ARATION OF THE LACE BEFORE INSTALLATION ...................................................22
17. INSTALATION...........................................................................................................23
1. UNLOCK/ LOCK OF THE READER...........................................................................23
2. ASSEMBLING THE SCREEN...................................................................................24
18. SWITCHING THE CAR® ON/OFF..................................................................................27
1. SWITCHING ON..................................................................................................27
2. SWITCHING OFF.................................................................................................27
19. READING ROCESS (CLART® Strips) ...........................................................................28
1. SETTING NUMBER OF SAM LES TO BE ANALYZED..................................................30
2. SETTING ASSAYS IDS...........................................................................................33
3. SETTING SAM LE’S IDS .......................................................................................35
4. WORKING LIST...................................................................................................37

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5. READING ROCESS .............................................................................................38
6. RUN RE ORT .....................................................................................................40
7. RESULTS............................................................................................................41
8. REANALYZING SAM LES......................................................................................42
20. MAIN MENU............................................................................................................45
1. HISTORY............................................................................................................45
2. CONFIGURATION ...............................................................................................46
21. FREQUENTLY ASKED QUESTIONS (FAQ) ......................................................................51
1. SOFTWARE U DATING AND INSTALLATION...........................................................51
2. EX ORT RESULTS-EX ORT ROUTE ........................................................................52
3. BARCODE READER: CHARACTERISTICS AND INSTALLATION. ....................................53
4. DEFAULT TEST CHANGE ......................................................................................53
ANNEX A. TABLE OF FREQUENT ERRORS AND THEIR SOLUTION ..........................................54
ANEXO B. DECLARATION OF CONFORMITY.......................................................................55
ANEXO D. USED SYMBOLS ..............................................................................................56

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2. PRINCIPLE OF OPERATION OF THE DEVICE
The CLINICAL ARRAY READER (CAR®) has been designed for a quick detection and
analysis of CLART-Strip®. The overall process of analyzing a sample involves several
steps:
•ADN extraction
•DNA amplification and target labelling
•Specific hybridisation and visualization of the results.
•Readin and interpretation of the results
The CLINICAL ARRAY READER (CAR®) has been desi ned for the readin and
interpretation phase of the In vitro medical devices manufactured by GENOMICA.
Amplification and visualization phase on CLART® is based on the precipitation of an
insoluble product at those sites of the microarray where the hybridization of the
amplified products by specific probes takes place.
This insoluble product shows a patron of spots on the array that will be interpreted by
the reader CAR® (CLINICAL ARRAY READER).
The technique is based on an image capturing system and a data processing unit from
the microarray, that generates a unique automatic report from each sample.
The algorism of every kit has been validated during the performance evaluation of the
kit. The result obtained by the CAR® are shown in a touch screen and they can be
printed or exported to a your LIMS or USB unit
The image capturing arrangement includes a LED that provides visible light towards the
array, a diffusor that homogenizes the stream of light before it reaches the array, and a
CCD camera, that captures the image.

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In order to the correct colocation of the tube or plate, the device is provided with an automatic
positioning system for the microarray.
The imagine processing is carried out in two formats (tubes and micro plates) by a specific
software developed by GENOMICA.
The image analysis is completely automated avoiding the subjectivity in the interpretation of the
results by the user. Therefore the result will be more accurate in a rapid and repeatable way.
Furthermore its design allows any kind of user an easy personalization.
In comparison to other systems of micro-arrays, this one simplifies the hybridation and
visualization process highly. This enables to survey biological samples for hundreds of disease-
associated biomarkers simultaneously, and obtain the needed controls to guarantee the
reliability of the results.

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Sample preparation, DNA extraction and DNA
amplification/labelling of targeted molecules
Specific hybridisation: labelled sample incubation
against AS-chip.
Visualization: conjugation and precipitation of the
staining.
Colorimetric Detection and Analysis.
CAR®
(CLINICAL ARRAY READER)
Standard
laboratory
equipment
Experimental Procedures
Visualization

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3. INTENDED USED
The CLINICAL ARRAY READER (CAR®) will exclusively be used by qualified laboratory staff in the following Tests
For any non-listed used, GENOMICA does not ensure the correct functioning of the equipment.
CLART® KIT NAME OBJETIVE TARGETS FOR DIAGNOSIS
KIT COMPONENTS
CLART® HPV2 Detection and typing of human
papillomavirus 2
Human apillomavirus 2 Kit detects up to 35 (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43,
44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71, 72, 73, 81, 82, 83, 84, 85 and 89)
•
Extracción Reagents
•Amplification Reagents
•Visualization Reagents
•Specific assay software
CLART® ENTHERPEX Detection and typing of Herpes and
Enterovirus.
HSV
-
1,HSV
-
2, VZV, CMV, EBV, HHV
-
6, HHV
-
7,HHV
-
8, oliovirus, Echovirus y
Coxsackievirus spp.
•
Extraction Reagents
•Amplification Reagents
•Visualization Reagents
•Specific assay software
CLART® EnteroBac® Detection and identification of genetic
Enterobacteriaceae causing diarrhea.
Salmonella spp. (all the described species in the manual), Shigella spp. (S. dysenteriae,
S. Sonnei, S. boydii and S. flexneri),Yersinia enterocolitica, Yersinia spp. (Y. pestis, Y.
pseudotuberculosis, Y. enterocolítica),Campylobacter spp. (C. lari, C. laridis, C.
upsaliensis, C. jejuni, C. coli) Campylobacter jejuni, Campylobacter coli, Escherichia coli
enteropathogenic E EC: (E. coli enterohemoragic, E. coli enteroinvasive, E. coli
enterotoxigenic and E. coli enteropathogenic), Clostridium difficile B, and Aeromonas
spp, producers of aerolisin .
•
Amplification Reagents
•Visualization Reagents
•Specific assay software
CLART® PneumoVir® Characterization of virus causing human
respiratory viral infections
Adenovirus; Bocavirus; Coronavirus; Enterovirus (Echovirus); Influenza virus A (subtypes
H3N2 human, H1N1 human, B, C and H1N1/2009); Metapneumovirus (subtypes A and
B); arainfluenza virus 1, 2, 3, and 4 (subtypes A y B); Rhinovirus; Respiratory Syncitial
Virus type A (VSR-A); Respiratory Syncitial Virus type B (VSR-B).
•
Extraction Reagents
•Amplification Reagents
•Visualization Reagents
•Specific assay software
Pneumo CLART bacteria® Characterization of virus causing human
respiratory bacterial infections.
Staphylococcus aureus, Streptococcus pneumonia, Haemophilus influenza,
Haemophilus spp, Moraxella catarrhalis, Chlamydophila pneumonia, Mycoplasma
pneumonia, Bordetella pertussis, Bordetella parapertusis, Bordetella bronchiseptica,
Bordetella holmesii, Bordetella spp.
•
Amplification Reagents
•Visualization Reagents
•Specific assay software
CLART® STIsA Detection and identification of pathogens
Chlamydia trachomatis: It will distinguish between t
he two serotypes groups: roducers
of lymphogranuloma venereum (LGV) include serotypes L1, L2 and L3 and Non -
producers of lym phogranuloma venereum (NLGV), include serotypes D-K. It will include
•
Extraction Reagents
•Amplification Reagents
•Visualization Reagents

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causing sexually transmitted infections
a
generic detection
of
Chlamydia trachomatis
for those cases
in which the serotype is
not achieve. Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis.
•
CAR ( Clinical Array Reader)
CLART® STIsB Detection and identification of pathogens
causing sexually transmitted infections
Ureaplasma urealyticum/parvum,Mycoplasma hominis,Candida
(C.albicans,C.glabrata,C.parapsilosis,C.krusei, C.tropicalis,C.guilliermondii,C.dubliniensis)
Treponema pallidum,Haemophilus ducreyi,Herpes Virus types I and II.
•
Amplification Reagents
•Visualization Reagents
•Specific assay software
CLART® SeptiBac Detection and identification of bacteria and
fungi causing septicemia.
Staphylococcus spp., Streptococcus spp., Enterococcus spp. Cocos Gram positivos
(CG s),Listeria monocytogenes, Clostridium perfringens, Escherichia coli, Klebsiella
spp.,Salmonella entérica, Enterobacter spp.,Citrobacter spp,Serratia spp., roteus spp,
Haemophilus spp ,Acinetobacter baumanii, Bacteroides , seudomonas
,Stenotrophomonas maltophilia, Candida spp.
•
Amplification Reagents
•Visualization Reagents
•Specific assay software
CLART® ETABONE Genotyping predisposing polymorphisms
have genetically related to bone metabolism
disorders.
olymorphisms detected: collagen type 1, vitamin D receptor, and estrogen and
calcitonin receptor.
•
Amplification Reagents
•Visualization Reagents
•Specific assay software
CLART® C A
NRAS-I KRAS
Detection and identification of point
mutations belonging to the path associated
with colorectal cancer EGFR
NRAS-I KRAS
•
Amplification Reagents
•Visualization Reagents
•Specific assay software
CLART® C A
KRAS.BRA. PI3K
Detection and identification of point
mutations belonging to the path associated
with colorectal cancer EGFR
KRAS , BRAF Y PI3K
•
Amplification Reagents
•Visualization Reagents
•Specific assay software)
CLART
®
C A
EGFR
Detection and genetic identification of oint
mutations, insertions and deletions in the
gene EGFR pathway associated to non-small
cell lung cancer
EGFR
•
Amplification Reagents
•Visualization Reagents
•Specific assay software)

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4. USE:
IN VITRO DIAGNOSTIC MEDICAL DEVICE
The CLINICAL ARRAY READER (CAR®) is to be used exclusively with the reactive
a ents supplied by GENOMICA.
Follow the usa e instructions carefully. lease do not set aside these instructions
without reading them: they contain useful information for correct, efficient
equipment management.
This appliance must not be used by anyone not endowed with the appropriate
experience or knowled e, unless they are acting under the surveillance of
someone responsible for their safety or they have received instructions about the
use of the appliance.
Usin CAR® in a manner other that stated in this manual would imply loss of
warranty.
.
.
5. CLASSIFICATION
The CAR® (CLINICAL ARRAY READER) complies with the provisions of Council Directive 98/79 / EC
regarding in vitro diagnostic medical devices, incorporated into Spanish legislation by way of
Royal Decree 1662 enacted on September 29th 2000, classified as “other devices” in Annex III to
the Directive.
What's more, GENOMICA SAU declares that the CAR® (CLINICAL ARRAY READERClinical Array
Reader) device was manufactured pursuant to the quality and safety requirements in force
(EN ISO 13485. EN 61010-2-101 and EN 61326-2-6)

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6. TRADING NAME OF THE PRODUCT AND REFERENCES
•CLINICAL ARRAY READER (CAR®).
•Reference: 1214
7. COMPONENTS
The CLINICAL ARRAY READER (CAR®) is a compact desktop instrument. Its configuration includes
a touch screen and a processing computer
When you receive the device, please make sure it includes the following components:
In addition, the device will be accompanied by the following accessories:
Accessory 1: software
The analysis of the images and interpretation of the results are carried out by software specific
to each kit, designed and implemented by GENOMICA.
GENOMICA distributes this software to its customers in accordance with the diagnosis kits it has
at its disposal.
1 x Screen
1 x processing computer

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The software is updated on a regular basis to meet any new demands, expand the applications
or improve their performance. These updates are installed by means of a GENOMICA software
assistant.
The software updating procedure for the different kits is defined in point: 23.1
Take particular care in ensuring that the USB device used, both for updating
software and for data export, does not contain any virus. GENOMICA will not be
held liable for removing any viruses that infect the system and which can be put
down to misuse by the user.
Accessory 2: A/C power cable:
This is used to connect the equipment to the supply system by means of a socket
Accessory 3: Replacement brakes:
To avoid any kind of damage to the reader during its shipment, any moving components must
be affixed by means of two securing or braking systems.
Accessory 4: Adapter (OPTIONAL)
The reader is capable of scanning 12 ATs (Array Tube). The tubes must be inserted into the
adapter to carry out the test in optimum fashion. The positions are labelled in line with the
following order: rows from A to C and columns from 1 to 4.
If the user makes a mi
stake when choosin the software, an error messa e
appears in the results' report. Please recheck the analysis you wish to carry out
and select the ri ht one.

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The CAR® reader has been designed solely for the detection and analysis of CS
(CLART-Strip®), ATs (Array Tube) and ASs (Array Strip). No other type of tube,
phial or equivalent material must thus be used. Using CAR® in a manner other
that stated in this manual would imply loss of warranty.
DO NOT use any accessory not provided by GENOMICA.
GENOMICA will not be held liable for using materials not provided by
the manufacturer.
All those accessories required for the proper use of equipment wi
ll be
provided by the manufacturer.
If any of these elements is missin , or of it is dama ed, please et in
touch with GENOMICA or a sales' a ent ri ht away.
9. SPECIFICATIONS.
DIMENSIONS:
Width
Width
Height
Height
Depth
Depth
Weight(without ta
ctile screen)
Weight(without tactile screen)
Fan replacement
Fan replacement
Additional 100mm space must be provided in front of the instrument for microplate
loading, as well as an additional 100mm space at the back and 50mm on the left for
cables and ventilation.

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ELECTRICAL SPECIFICATIONS:
Rated power
150 W
Fuse type and rating two fuses
5x20 mm, 250V(AC)/ 1,6A slow
-
blow
Fuses 2xT4H250V( 5x20 mm)
Voltage
100
–
240 V (AC) a 50/60 Hz
INTERNAL PC SPECIFICATIONS:
Operating System
Windows X Home E
dition
rocessor:
Intel entium II 1.6 GHz ( o mayor)
Ram Memory
1 GByte DDR
-
2
Hard disk
40 GByte
Connections
VGA,RS232 (mouse and Keyboard) Serial
100Base-T Ethernet, 3xUSB2
PERFORMANCE:
Light source: 660 nm red visible LED
Sensor: 2088 linear imager
Bandwidth: Ancho de banda: 3.25” (80mm)
Resoluciónof the camera: 8.3 Mpixel
Scan time for 45 scans / sec .
Scan time for 100 scans / sec .
Dynamic Range: 8 bits, 255 greysaclae.

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TOUCH SCREEN
Type
12.1” TFT LCD
Resolution
800x600
Colours
2
64 K
Connections
12V, VGA, USB
-
B,
Mechanical mount
VESA 75.
Max current for 12VDC
tactile screen supply:
3 Amp.
ESPECIFICACIONES
Scan time for complete 96-well plate: 2-3 minutes.
Resolution of the sample 3 µm
10. UNPACKING, STORAGE AND PACKING.
lease read the whole manual before unpacking and installing the device or working
with it. ay attention to all the hazard and warning indications. Should you fail to do so,
it may cause serious injuries to the user or damage the device. To ensure that the
protection provided by this device does not deteriorate, do not use or install it in any
way different from that stated in this manual.
UNPACKING
Check that, when you receive it, the packing is complete; otherwise, notify the haulier or
area Agent immediately.
To open the packaging, follow the points set out below:
1. Open the box and take out the copy of the user manual; follow the
operations in line with the indications set out in the manual.

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2. ick up and take out the device. Make sure you have the right means at your
disposal to pick the unit up and put it at its permanent place of fixture.
3. Check the content of the packaging and make sure it matches that stated on
the outer label.
STORAGE
If the unit is not in its permanent position and is stored on the floor or in some uneven
area, protect it and take suitable measures to this end.
The unit contains delicate components which work in vertical position and particular
care must be taken to avoid any twisting of the device structure during its storage.
MOVING / TRANSPORT
If any change in its location is required, lift it and move it.
Never push or dra it. To move it properly, the equipment must have its brakes
properly installed:
It is important to keep this manual in order to be able
to consult it at any time!
In the event of sale, transfer or moving, make sure that
it remains with the device so as to inform the new
owner about its operation and provide him with the
attendant warnings.
PACKAGING
If the reader has to be dispatched, it is vital that both safety screws have been put back
in. With this in mind, please follow these instructions carefully:

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1. Turn the reader off completely and turn it off from any power supply.
2. ut your hand into the front aperture of the reader and move the internal tray
totally to the right. Secure the lateral safety screw.
3. Now move the tray backwards and secure the second safety screw in its place.
Keep the ori inal packa in materials!
Any instruments returned for their recyclin /repair
must be sent in the ori inal packa in material to
protect them from any dama e durin transport.
11. ENVIRONMENTAL CONDITIONS
Optimum stora e conditions.
Optimum temperature Relative Humidity
between 5 and 40º C 10 – 75 %
Optimum operatin conditions for use at the laboratory (interiors).
Temperature
Relative
Humidity
Pressure Ventilation and cooling conditions:
15- 40º C 10– 75 %
700-1200 h a,
*less than
2000m above
sea level.
A space of 10 cm must be kept free
in front of the device to ensure
movement of the plate. A free
space of 5 cm is also required at the
rear of the equipment for
ventilation

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Do not use this instrument in the proximity of strong
electromagnetic radiation sources as they may interfere with
proper operation
The user is responsible for ensuring that an electromagnetic
environment is maintained which is compatible with the
equipment so that the device works according to plan
In a magnetic environment the operation of the device must be
evaluated before its routine use
12. USAGE PRECAUTIONS
TAKE CARE! Read the following stipulations carefully
All the precautions stated on this page must be followed carefully to avoid any injury to
people and/or damage to the device.
Take particular care with electrical components. Take safety
measures at all times. The electrical repair service of the
equipment may only be carried out by qualified staff
Do not tamper with any of the electronic components of the
appliance. In the event of any breakage or error, please get in
touch with the technical service of GENOMICA

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Always unplug the CAR® reader before carrying out any work
involving the use of liquids or when you are going to carry out any
electrical maintenance or maintenance of any of the internal
components of the equipment.
If the laboratory power supply suffers any failures or surges, the
use of an uninterruptible power supply source (U S) is
recommended.
Do not try to open or force the external protection casing of the
appliance. Avoid any vibration or sudden movement of the
appliance during the reading and analysis process.
Contact with the skin may occur when handling potentially
infectious substances (such as human or reactive samples), so
gloves must be worn.
The user must take special care not to contaminate the interior of
the equipment, making sure that he has correctly removed the
liquid from the wells before placing the plate. Furthermore, the
precaution must be taken of NOT contaminating with biological
samples the exterior of the device, whether the casing or the
various connection ports (USB, Ethernet etc.)

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13. MAINTENANCE
The CAR® reader DOES NOT require calibration nor maintenance.
In the event of an incident, please get in touch with GENOMICA or
your local distributor.
Only change the fuses when they blow. With this in mind, follow the steps set out
below:
1. Take out the fuse-holder by pressing the lower and upper tabs.
2. Replace the blow fuses and re-insert the fuse-holder by firmly pressing its central
part.
3. The fuse type is stated on the Reader label: 2xT4H250V( 5x20 mm)
14. CLEANING
Only clean the outside of the equipment. Only use the following products: domestic
dishwasher, 5% bleach, isopropyl alcohol, window cleaner or 3% oxygenated water.
Any other compound or cleaning solution is not authorised.