GENOMICA CAR User Manual
  1. Manuals
  2. Brands
  3. GENOMICA Manuals
  4. Laboratory Equipment
  5. CAR
  6. User manual

GENOMICA CAR User Manual

Clinical array reader
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
CLINICAL ARRAY READER
(CAR®)
USER MANUAL
User manual
Version 8 July 2015
1

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the CAR and is the answer not in the manual?

Questions and answers

Related Manuals for GENOMICA CAR

Summary of Contents for GENOMICA CAR

  • Page 1 CLINICAL ARRAY READER (CAR®) USER MANUAL User manual Version 8 July 2015...
  • Page 2 CAR® (CLINICAL ARRAY READER) CAR, CLART, CLART-Strip, SAICLART, ENTHERPEX, ENTEROBAC, PNEUMOVIR, PNEUMO CLART BACTERIA and SEPTIBAC are registered Trademarks of GENOMICA. For more information, please refer to the web site 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...

  • Page 3: Table Of Contents

    16. PREPARATION OF THE PLACE BEFORE INSTALLATION ........... 22 17. INSTALATION ......................23 UNLOCK/ LOCK OF THE READER ................23 ASSEMBLING THE SCREEN ................... 24 18. SWITCHING THE CAR® ON/OFF .................. 27 SWITCHING ON ....................27 SWITCHING OFF ....................27 19. READING PROCESS (CLART® Strips) ................28 SETTING NUMBER OF SAMPLES TO BE ANALYZED ..........
  • Page 4 READING PROCESS ..................... 38 RUN REPORT ..................... 40 RESULTS ......................41 REANALYZING SAMPLES ..................42 20. MAIN MENU ......................45 HISTORY......................45 CONFIGURATION ....................46 21. FREQUENTLY ASKED QUESTIONS (FAQ) ..............51 SOFTWARE UPDATING AND INSTALLATION ............51 EXPORT RESULTS-EXPORT ROUTE ................ 52 BARCODE READER: CHARACTERISTICS AND INSTALLATION.

  • Page 5: Principle Of Operation Of The Device

    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...
  • Page 6 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.
  • Page 7 Sample preparation, DNA extraction and DNA laboratory amplification/labelling of targeted molecules equipment Specific hybridisation: labelled sample incubation against AS-chip. Visualization: conjugation and precipitation of the staining. Colorimetric Detection and Analysis. CAR® (CLINICAL ARRAY READER) User manual Version 8 July 2015...

  • Page 8: Intended Used

    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. KIT COMPONENTS CLART® KIT NAME OBJETIVE TARGETS FOR DIAGNOSIS •...
  • Page 9 • causing sexually transmitted infections a generic detection of Chlamydia trachomatis for those cases in which the serotype is CAR ( Clinical Array Reader) not achieve. Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis. • Ureaplasma urealyticum/parvum,Mycoplasma hominis,Candida Amplification Reagents Detection and identification of pathogens CLART®...

  • Page 10: Use

    Using CAR® in a manner other that stated in this manual would imply loss of warranty. 5. CLASSIFICATION The CAR®...

  • Page 11: Trading Name Of The Product And References

    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.
  • Page 12 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.

  • Page 13: Specifications

    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.
  • Page 14 ELECTRICAL SPECIFICATIONS: Rated power 150 W 5x20 mm, 250V(AC)/ 1,6A slow-blow Fuse type and rating two fuses Fuses 2xT4H250V( 5x20 mm) Voltage 100 – 240 V (AC) a 50/60 Hz INTERNAL PC SPECIFICATIONS: Operating System Windows XP Home Edition Processor: Intel Pentium II 1.6 GHz ( o mayor) Ram Memory 1 GByte DDR-2...

  • Page 15: Unpacking, Storage And Packing

    TOUCH SCREEN Type 12.1” TFT LCD Resolution 800x600 Colours 264 K Connections 12V, VGA, USB-B, Mechanical mount VESA 75. Max current for 12VDC 3 Amp. tactile screen supply: ESPECIFICACIONES Scan time for complete 96-well plate: 2-3 minutes. Resolution of the sample 3 µm 10.
  • Page 16 2. Pick 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.

  • Page 17: Environmental Conditions

    Turn the reader off completely and turn it off from any power supply. Put your hand into the front aperture of the reader and move the internal tray totally to the right. Secure the lateral safety screw. Now move the tray backwards and secure the second safety screw in its place. Keep the original packaging materials! Any instruments returned for their recycling/repair must be sent in the original packaging material to...

  • Page 18: Usage Precautions

    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 User manual Version 8 July 2015...
  • Page 19 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 (UPS) is recommended.

  • Page 20: Maintenance

    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.

  • Page 21: Caring For The Device After Use

    Note: In the event of returns for recycling, please get in touch with GENOMICA or the device supplier to obtain instructions about how to return devices whose life cycle is complete for their proper disposal.

  • Page 22: Preparation Of The Place Before Installation

    Follow the detailed instructions below for the correct preparation of the place before installation. Clear an area of around 1 m for installation of the CAR®, making sure you can access the disconnection device (rear part of the equipment). Once installed, the appliance must not be moved.

  • Page 23: Instalation

    1. UNLOCK/LOCK OF THE READER In order to avoid system damages during transport, internal mobile components of the CAR® are locked. In order to unlock the reader, remove the big screw on the back and side. During transportation, the position of the tray holder is fixed by locking screws, in order to protect the mechanical components.

  • Page 24: Assembling The Screen

    • Turn off the instrument and remove the main power connection. • Slowly slide the tray holder manually fully towards the rear wall and place the screw at the rear of the CAR®. • Then slide the tray holder fully to the right and place the screw on the side.
  • Page 25 Fig. 3: Yellow: two lower screws to hold the screen.. Red: Holes dedicated for installing and securing the screen 2. Lean the screen over the reader fitting the screws with the positions marked in yellow. Insert the safety locking screws recently removed (green circles, below) in the positions marked in red (Fig.
  • Page 26 Fig. 5: Installed screen 1. Connecting cables: 1a) Connect the power supply (Type Jack 3.5) 1b) Connect the USB connection to one of those at the right side. 1c) Connect the VGA connection to the blue connector. 2. Switch on the screen by pressing the button on top. User manual Version 8 July 2015...

  • Page 27: Switching The Car® On/Off

    2. SWITCHING OFF First press the “on /off icon” on the main menu of the CAR®( see fig 8). When switching off the device is safe, a message will be shown in the screen .Then, turn off the main switcher at the rear side.

  • Page 28: Reading Process (Clart® Strips)

    Fig. 8: Switer at the main menú of GENOMICA´s application .press the switcher icon to switch off the reader It is important to shut down the CAR® completely when not required, as this may prolong the service life of the equipment.
  • Page 29 Fig.9: Selecting “New Analysis”option at the main menú Once this option is selected, a new menu will pop up on the screen, where 96 wells microplate sketch is depicted (Fig. 10). Fig. 10: 96 wells microplate sketch in the “New Analysis” menu. This menu represents the cornerstone of the application, since it allows the user to: •...

  • Page 30: Setting Number Of Samples To Be Analyzed

    Automatic setting: For the automatic setting of sample’s number, user will need a bar-code reader connected to the CAR® (normal USB connection)(See FAQ). GENOMICA will provide the user with specific bar codes for each assay. Press “Auto assays” option, placed on the lower side of the screen (Fig.11) Fig.11: Select “Auto enssay”.
  • Page 31 Fig. 12: Authomatic insertion of the number of the samples with the assay reference Then read the specific the bar code of the essay and automatically, the microplate sketch will show selected the specific number of Ass readed Every barcode read activates a strip automatically, on the microplate sketch and the colour turns from grey into a specific assay’s colour combination.depending on the type of the essay .
  • Page 32 Fig. 13: To stop the automatic import of the essays ´s references. Manual setting: Software’s default settings, unselect automatically all the strips of the microplate, composed by up to 12 strips, thus every strip not included in the process must be manually desactivated by the user.

  • Page 33: Setting Assays Ids

    Fig. 14: Unselecting the non- analized strips 2. SETTING ASSAYS IDS The automatic setting of sample’s number, in the previous section, allows the user to skip this step. Setting Assays IDs Manually: Software’s default settings is CLART® HPV2 (MM) on strips Should you need to change the default assay, press the , button on the “New Analysis”...
  • Page 34 Fig. 15: Manual insertion of the essay references . Press , when finish, to return to previous menu and follow up with the visualization process. Once assigned the assays’ IDs, strips will turn to the different colour combination specific for each type of analysis. (Fig. 16). User manual Version 8 July 2015...

  • Page 35: Setting Sample's Ids

    Fig. 16: Each essay has an specific combination of colors 3. SETTING SAMPLE’S IDS In the same way that in previous sections, setting samples IDs can be carried out, automatically or manually. In the same way that in previous sections, setting samples IDs can be carried out, automatically or manually.
  • Page 36 Fig. 18: Pantalla de inserción de referencias de muestras. Setting Samples IDs Manually To set the references of the samples manually, each code should be written in the specific position . Press on each position and type the code manually (Fig. 19) Fig.

  • Page 37: Working List

    Once finished press for getting back to the microtiter plate menu and from there, press to continue with the reading process. 4. WORKING LIST The working list allows the user to check, whether the already introduced information (samples refer-ences, assays...) is correct or not. To change any data, just press “Back”...

  • Page 38: Reading Process

    Reader’s tray opening and closing processes are performed automatically. Do not try to force or move it manually. If necessary, press the emergency button placed on the rear side of the In CAR®. User will be requested to initialize the process by pressing the “Open Tray” icon.
  • Page 39 Fig. 21: Application request to close the tray after positioning the micro plate on the tray. Once the microplate is placed, the analysis of the samples will start automatically. Reading procedure can be monitored in the screen since samples/wells change their color indicating the reading status.

  • Page 40: Run Report

    Once finished the reading process, user will be requested again to initialize the opening and closing procedures. (Figs. 20 and 21). 6. RUN REPORT The CAR® generates a final report including following information: • Date and time • Position of the sample •...

  • Page 41: Results

    "Printer" button (See FAQ) • Image: To visualize the image obtained by the CAR®. • Raw Data: To consult raw and normalized numerical values obtained in the analysis of the samples.

  • Page 42: Reanalyzing Samples

    Fig.24: Menu of results Fig. 25: Example of a taken image. 8. REANALYZING SAMPLES After the analysis process, red colored wells, where the grid alignment has failed, can be reanalyzed manually by user. In the microplate sketch menu, press on a red coloured sample/position to activate the reanalysis main menu window.
  • Page 43 Fig.26: Reanalize option in the initial menú . Change the reference of the essay. Please ensure that the selected assay is the desired one ) and press “Start Reanalyze”. By operating “Start Reanalyze” button, user accedes to the reanalysis application. Zoom tool, placed on the upper right corner of the screen, facilitates the reanalysis process: (Fig.
  • Page 44 Once the grid is squared properly, according to array’s dot micromatrix, press “Reanalyze” button (Fig. 28). Fig. 28: Placing metal markers according array’s matrix Once the metal markers are aligned, press “Reanalyse” option (Fig 23) and an image with the grid will show the final alignment. If both, dots and metal markers fits press “Accept” (lower- right side).

  • Page 45: Main Menu

    Manual grid alignment implies user’s intervention in the results. If a manual grid alignment is required, an informative message will be shown in the run report. “Sample has been reanalyze by user” (Fig30) “Sample has been reanalyze by user” Fig.30: 20.

  • Page 46: Configuration

    Touching on desired result will give access to a menu where the user can again export, print or visualized results obtained 2. CONFIGURATION By operating “Configuration” option, CAR® allows the user to personalized the different set ups according to specific necessities. (Fig. 55): User manual...
  • Page 47 D. Version management: for controlling the different software versions installed. A. INSTALL /UPDATE: This option allows the user to both, install and uninstall software provided by GENOMICA. For installing software , just plug in the USB key containing the zip file with the software , wait un-till the software is listed on the screen and press “Install”...
  • Page 48 Fig. 56a: Selección de “Instalar” en el Fig.56b: Menú de selección de kits a submenú “Servicio”. instalar. B. SYSTEM/SETTINGS: System/settings option allows the user to personalize the interfaces and performance characteristics. (Fig. 57) Fig.57b: Software sets English as default language. Select the most suitable language from Fig.
  • Page 49 GENOMICA strongly advises to perform a weekly backup of results. In case of reader damage or software failure it’s not always possible for the technical servicing to restore the data. GENOMICA declines any responsibility over those not saved data. Once selected the backup option, user will be requested to confirm the backup path .
  • Page 50 Fig. 59a: Select “Backup”. Fig.59b: Dates Sellection . Then the software shows two options: A) Copy: Keep the reader memory once the backup is done B) Move: erase the reader memory once the backup is done Press “following ” to finish the backup process . D.

  • Page 51: Frequently Asked Questions (Faq)

    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 which infect the system and which are the result of misuse by the user.

  • Page 52: Export Results-Export Route

    Fig. 62 Example of error message. 2. EXPORT RESULTS-EXPORT ROUTE The analyses carried out with the CAR® may be stored in external data storage system or in other directories (LIMS). The user may select the desired data export route. An example has been provided below of how to export data to a pen drive: Select the “Set-up”...

  • Page 53: Barcode Reader: Characteristics And Installation

    Using the option “...”, select the directory “D:\” which usually corresponds to the pen drive connected to the rear of the reader. The export of files after each test will be carried out to the selected route. 3. BARCODE READER: CHARACTERISTICS AND INSTALLATION. It is recommended to use a simple bar code reader as the installation process is carried out automatically after connecting it to the reader by means of a PS/2 or USB connection.

  • Page 54: Annex A. Table Of Frequent Errors And Their Solution

    ANNEX A. TABLE OF FREQUENT ERRORS AND THEIR SOLUTION ERROR SOLUTION Check whether the device is connected to the mains. The device does not come on Check fuses, subject to disconnection from the mains. The touch screen does not respond. Check rear USB connection The device is heating up Clean rear ventilation filter...

  • Page 55: Anexo B. Declaration Of Conformity

    ANEXO B. DECLARATION OF CONFORMITY User manual Version 8 July 2015...

  • Page 56: Anexo D. Used Symbols

    ANEXO D. USED SYMBOLS This symbol indicates the user must refer to the manual for further information. This symbol indictes the posibility of damage for the normal use of the device. This symbol indicates that, under normal use, hazardous voltages may be present This symbol indictes that the User Manual should be read carefully ATS ANALYSES...

Table of Contents