User manual CAR
Contents
1. ccccccecccesccceccccecccecsccecccessceueceasecessecerseeseesateetseecteeeesseesteeeees 18 13 20 IA a E LINT CREER 20 15 CARING FOR THE DEVICE AFTER USE c cceccccecceeececescecscccessceceecsseeeseeecseeeeseeeseenseeeees 21 16 PREPARATION OF THE PLACE BEFORE INSTALLATION 0 cccccceccececceceseeeseeceseeeseeeereeeees 22 WANA NN NOIN 23 1 UNLOCK LOCK OF THE READER cccccceccccescececcececcetecescecesseceseceesseecseecuseeeteeseees 23 2 ASSEMBLING THE SCREEN ccccceccceccececcceececeacececscsceceaseceacescecsasesetecsusessseseers 24 18 SWITCHING THE CAR 27 1 SWITCHING 0 27 WEE ire IN NNN imr HDH HH HHHH HHHH lt HNH 27 19 READING PROCESS CLART Strips juke k y K AKA nni 28 1 SETTING NUMBER OF SAMPLES TO BE ANALYZED eene 30 2 SETTING ASSAYS 6 22 4 arkana arannana nran 33 3 SETTING 5 5 05 04 0 erre trennen 35 4 WORKING 5 37 User manual Version 8 July 2015 3 GEN MICA 5 READING PROCESS m 38 6 RON M1520 1 areenaan A 40 2 J r E r rrr a 41 8 REANALYZING SAN xin dika2. CLART SEPTIBAC_T2 6sc 3 140918 CAR zip Videos 4 jj CLART STIs A 10sc 10 130920 CAR zip ib CLART STIs 8 105c 11 130923 CAR zip ore CLART STIs AB 10sc 12 130924 CAR zip amp Disco local C ew VERBATIM E d Autoclart di CALIDAD di CAR Fig 61 USB Memory with installation files Connect your pen drive to a free USB port of the CAR Enter the Set up menu Press the Install Update button In the explorer you should see unit C of the reader and your pen drive in the majority of cases identified by the letter D The reader can sometimes take a few minutes to recognise the pen drive Go back to the main menu wait a moment and then try again Access your USB memory by pressing the box with the sign Here you can see the zipped files required for installation Select kit you wish to install and press Install The installation will take several minutes and it will end with a window that will tell you whether the process has been completed successfully User manual Version 8 July 2015 51 GEN MICA CLART HPV2 install ok Please close the window by pressing the button in the upper right hand corner If you wish to install further kits repeat the operation as from step 4 When you ve finished return to the main menu and restart the device If error messages appear please get in touch with your technical service Don t forget to quote the text of said messages in your request for a
3. is correct or not To change any data just press Back and repeat the setting process again see Set Samples IDs Manu ally and Set Assays ID Automatically If all information is correct press Start run to carry on with the process Fig 20 Lista de trabajo m BunID 2015 01 28 11 46 31 137 a Fecha y hora Wed Jan 28 11 46 44 2015 GENS 50208 CLART 2 8 50208 CLART HPV2 50208 CLART HPV2 30208 CLART 2 30208 CLART HPV2 30208 CLART ole elt e e e e 5 5 e 30208 CLART HPV2 2 59208 CLART HPV2 2 30208 CLART 2 gt SIS 5 23 e e e e 2 5 Z s amp amp gt Jm H n mm l l ms lm 5 25 5 e 5 5 5 gt gt Oy gt lt gt gt 3 gt cn 2 50208 CLART HPV2 7 50208 ICT ART HPV 8 8 8 8 8 50208 CLART HPV2 amp 8 8 8 8 wa JE 5 amp 2 Q INICIAR RUN Fig 20 Working list appearance Position assay reference and IDs well number and sample ID are listed Results will be shown after the analysis at the summary report Printer icon can be shown at the upper right side of the screen User manual Version 8 July 2015 37 GEN MICA 5 READING PROCESS Una vez seleccionado Iniciar Run se comenzar con l
4. kal ka YI k za ka kan ka kul Li Lata ku kal kal ha ena kan kazan lai lal lal Fig 52 History option at the main menu of Fig 53 searching engine possibilities In order the application to speed up the searching process After that user will be requested to perform the search by run number by essay reference or by sample reference Fig 54 User manual Version 8 July 2015 45 Searching by Run Search by Essay ID Search by Sample ID All run essays samples corresponding with the search entered will be listed in the following screen 2014 12 23 09 23 15 2015 01 28 11 59 47 2015 01 28 12 53 32 2015 01 28 15 24 21 Fig 54 list of results matching the searching criteria 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 Version 8 July 2015 46 GENE MICA P d Gen micr VERSION MANAGEMENT NUEVO ANALISIS 3 HIST RICO INSTALL UPDATE CONFIGURACION SYSTEM SETTINGS Fig 55 Configuration option at the GENOMICA s application main menu The configuration submenu contains several options as A Install Update for installing a
5. CLART 00000000050208 2 2 Tipo 71 Tipo 81 Tipo 43 4 _ 50208 CLART HPV2 00000000050008 3 3 Aa s T r s M SIS qu MES EE 50208 CLART HPV2 00000000050208 m s Bs 50208 CLART HPV2 00000000050208 5 5 Negative El alinzamiento de la cuadricule Sito 50208 00000000050208 6 6 50208 CLART HPV EE ARE indoor a an 5 5 z El clinzemiento de s cuadsiculs Sito 5070 gt S070 30208 HPV2 00000 0208 Et no puede ser 50208 CLART HPV2 00000000050208 Tipo 84 yarane OSE Den ne Sek A a x x User manual Version 8 July 2015 40 GEN MICA Fig 23 Run report appearance Run report will be exported automatically attached to the results in case of exporting them Can be also printed out directly by connecting a simple printer 7 RESULTS To visualize a specific sample s result select the sample position on the microplate sketch by pressing on it A new menu showing working list and results will appear on the screen On this menu following options are shown e Export To export reports and results to an external server LIMS or USB e Print If an external printer is connected via USB port the selected result s page or all results data pages including test image can be printed by operating the Printer button See FAQ e Image To visualize the image obtained by the CAR e R
6. 28 e 01 2015 Hora 15 44 BACKUP OM E Exportaci n CACLEISIDatalExport cem Backup C CLEIS Data Backup VERSION INSTALL UPDATE MANAGEMENT es EAANVIKG Z _ Espa ol Portugues ESI English e SYSTEM SETTINGS M Por defecto CLART_HPV2_8sc 8 CLART_HPV4_13sc 9 CLART_METABONE_5 3 CLART STIs B 10sc 11 Fig 63a System Set up option Fig 63b Date export route language selection kit by default User manual Version 8 July 2015 52 6 GEN MICA Using the option select the directory D V 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 Technical recommendations for the barcode reader Linear symbols it encodes Codabar Code 3 of 9 Code 39 Code 3 of 9 Full ASCII Code 11 Code 32 Code 93 Code 128 EAN JAN 8 EAN JAN 13 Industrial 2 of 5 25 Interleaved 2 of 5 ISBN Matrix 25 MSI Plessey UPC A UPC E China Post Code RSS14 Telepen 4 DEFAULT TEST CHANGE The CLART HPV2 test on the plate is determined by default However another analysis may be determined by
7. Gd a Rh a hti e 42 LO NAIN MIE NG 45 Ls IES TOR eenn EE E S E E EES 45 2 LONRIGORANON vars E EE EEE E EE ee 46 21 FREQUENTLY ASKED QUESTIONS mmm nnne 51 1 SOFTWARE UPDATING AND 51 2 EXPORT RESULBTSSEXPORTI ROUTE iy kaya an yane y k dara w k k exar Uns 52 3 BARCODE READER CHARACTERISTICS AND 53 4 DEFAULT TESI CHANGE ney 53 ANNEX A TABLE OF FREQUENT ERRORS AND THEIR 54 ANEXO B DECLARATION OF CONFORMITY maka keka kak ski a a kr b 55 5 56 User manual Version 8 July 2015 4 GEN MICA 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 e ADN extraction DNA amplification and target labelling Specific hybridisation and visualization of the results Reading and interpretation of the results The CLINICAL ARRAY READER CAR has been designed for the reading and interpretation phase of the
8. default on the Set up menu under the System option Consult page 44 of this manual User manual Version 8 July 2015 53 GEN MICA 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 The device is making strange noises Clean rear ventilation filter If the solution is unable to remove the error go to the Authorised Technical Assistance Service User manual Version 8 July 2015 54 GEN MICA ANEXO B DECLARATION OF CONFORMITY EC Declaration of Conformity Company GENOMICA S A U 7 28823 Coslada Madrid Produce CAR Clinical Array Reader References Classification Other products Conformity assessment route Annex of Directive 98 70 EC EC Declaration of Conformity GMDN Code 57802 Genomica S A declares that the diagnostic device CAR Clinical Array Reader conforms to the relevant provisions of the EC Council Directive 98 79 EC on in vitro diagnostic medical devices transposed to the Spanish legislation 1n the Royal Decree 1662 2000 of 29 September 2000 Standards applied EN 150 9001 2008 ISO 13485 2012 2003 EN 149712012 EN 9802008 EN 13612 2002 EN 18113 12011 1501
9. hold the screen Red insertion zone of the Screws Once installed screen s arm should appears as follows Fig 5 User manual Version 8 July 2015 25 GEN MICA Fig 5 Installed screen CONEXIONES Fig 6 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 26 GEN MICA 18 SWITCHING THE CAR ON OFF 1 SWITCHING ON Plug the reader in and switch it on The main switcher is on the rear left side of the device connecting the device to the power involves grounding Press then the secondary switcher on the front side of the CAR and wait until function s gauge turns green Once your CAR is switched on the instrument will initialize during this time the instrument will verify its good performance by a series of self tests After finishing this set of self tests the Main Menu screen GENOMICA application CLAIS will appear on the touch screen Fig 7 MICA Fig 7 Secondary switcher at the front side 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 Do not switch off t
10. 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 tubes c Bdapter User manual Version 8 July 2015 12 GEN MICA 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 GENO
11. sample s number to be processed User manual Version 8 July 2015 29 GEnemicA e Set assay CLART HPV2 CLART PneumoVir CLART ENTHERPEX CLART CMA e Set sample ID Sample Reference 1 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 gt OOOOOOOO OOOOOOO m n o O O Q O x WELL PLATE SET AZSAYT AUTO SET SAMPLE IDS Fig 11 Select Auto enssay In the microplate sketch will show all the ASs columns in light grey what indicates they are not selected in the analysis Fig 12 User manual Version 8 July 2015 30 GEN MICA Zela 24 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 Red yellow CLART HPV2 Metalic markers Blue yellow CLART Pneumovir Green y
12. screws Fig 1 Fig 1 Unlocking the CAR Position of the locking screws User manual Version 8 July 2015 23 GEN MICA Place the white plastic cap attached in the hole left by the lock screw at the side of the CAR Fig 2 Fig 2 Covering the side hollow left by the screw Should you need to send your instrument the locking screws MUST be screwed securely in their positions To install the transport locking screws please follow these brief instructions Turn off the instrument and remove the main power connection e Slowly slide the tray holder manually fully towards the rear wall and place the screw at the rear of the CAR e Then slide the tray holder fully to the right and place the screw on the side e Tight them securely 2 ASSEMBLING THE SCREEN Touch screen is provided separately In order to connect it to the reader please follow these indications 1 Unscrew partially the two lower screws see fig 3 marked in yellow these two lower screws will hold the screen User manual Version 8 July 2015 24 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 4 Fig 4 Green safety screw Yellow Holes to
13. 2015 43 GEN MICA 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 If new adjustments are required press Retry Fig 29 m Reanalyze Wee ON oe 9 9 0 29 Grid alignment checking User manual Version 8 July 2015 44 GeEnemicr 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 MAIN MENU 1 HISTORY By operating the History option user accedes to a secondary menu were user will be requested about the dates between them the essay was performed OF OCHO a Of 0 NEEND AN LISIS OE l Dera HIST RICO an aii ka ka kal kal kul ku ka kal am Ll i OR al kan kan al Lt kal
14. 8113 2 2009 EN 2623042006 CORR 2008 61010 2 101 2002 EN 61326 2 6 2013 Notified Body NA EC Certificate NA Period of validity NA Madrid 119 September 2014 Authorised Signatory Name Dra Cospedal Position Managing Director GENOMICA Rejim Mamaril Madid Tama 404 Faia 174 Haan M7906 Inseripei n 14 05 11 30 CLF A 7944 718 User manual Version 8 July 2015 55 GEN MICA 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 SEE THE MANUAL OF USED MANUFACTURER MANUFACTURE DATE IN VITRO DIAGNOSTIC DEVICE EXPIRY DATE SERIE NUMBER LOT CODE REFERENCE CE MARK Fuses 2xT4H250V 5x20 mm This symbol indicates that the electronic equipment should not be dispose of in the normal waste Instead it should be dispose according with the waste electronic and electronical equipment WEEE Directive User manual Version 8 July 2015 56
15. MICA will not be held liable for using materials not provided by the manufacturer All those accessories required for the proper use of equipment will be provided by the manufacturer If any of these elements is missing or of it is damaged please get in touch with GENOMICA or a sales agent right away 9 SPECIFICATIONS Depth Depth Weight without tactile 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 User manual Version 8 July 2015 13 GEN MICA ELECTRICAL SPECIFICATIONS 5x20 mm 250V AC 1 6A slow blow Fuse type and rating two fuses Fuses 2xT4H250V 5x20 mm INTERNAL PC SPECIFICATIONS Windows XP Home Edition VGA RS232 mouse and Keyboard Serial Connections 100Base T Ethernet 3xUSB2 Bandwidth Ancho de banda 3 25 80mm Resoluci nof the camera User manual Version 8 July 2015 14 GEN MICA 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 um 10 UNPACKING STORAGE AND PACKING Please read the whole manual before unpacking and installing the device or working with it Pay attention to all the hazard and warning indications Should you fail to do so it
16. Syncitial Virus type A VSR A Respiratory Syncitial Virus type B VSR B Staphylococcus aureus Streptococcus pneumonia Haemophilus influenza Haemophilus spp Moraxella catarrhalis Chlamydophila pneumonia Mycoplasma pneumonia Bordetella pertussis Bordetella parapertusis Bordetella bronchiseptica Bordetella holmesii Bordetella spp Chlamydia trachomatis It will distinguish between the two serotypes groups Producers 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 KIT COMPONENTS Extracci n Reagents Amplification Reagents Visualization Reagents Specific assay software Extraction Reagents Amplification Reagents Visualization Reagents Specific assay software Amplification Reagents Visualization Reagents Specific assay software Extraction Reagents Amplification Reagents Visualization Reagents Specific assay software Amplification Reagents Visualization Reagents Specific assay software Extraction Reagents Amplification Reagents Visualization Reagents e ee causing sexually transmitted infections CLART STISB CLART SeptiBac CLART METABONE CLART CMA NRAS I KRAS CLART CMA KRAS BRA PI3K CLART CMA EGFR User manual Detection and identification of pathogens causing sexually transmitted infections Detection and identification of bacteria and fungi causing septi
17. Ultima calibraci n Hora amp 5 fo Exportaci n CACLEISIDatalExport 1 J N _C CLEIS Data Backup ss EAAnVIKG Lenasal 2 CLART 2 8sc 8 CLART 4 13sc 9 CLART METABONE 5 3 STIs B 10sc 11 u nt Fig 58 Select the field in the option Backup path in order to consult the destination files Once set the back up path user can backup results by pressing the Backup button lector Backup In the setting Menu press the Backup option to the process initiation and select the dates to preserve Fig 59 User manual Version 8 July 2015 49 GENE MICA 4 P d Zawa P d Gen micr 6 6 OPO ese ese omo BACKUP D ae Lan ku kal ku a kal aa kal a ka kal ka kal kal kal u kan kan kaz han kan ku kan kul lal kal kul lav Nen Ea ku ku Eu ka kul kul ka kal kul lan kul ku s k kuz i L_J Run ID Ensayo VERSION INSTALL UPDATE MANAGEMENT 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 SETTINGS Settings menu Fig 60 allows the user to A
18. User manual b 4 y 2 P a gt GEN MICA CLINICAL ARRAY READER CAR USER MANUAL Version 8 July 2015 1 GEN MICA 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 ul GENOMICA S A U Parque Empresarial Alvento Edificio B Calle Via de los Poblados 1 18 planta 28033 Madrid Spain WWW gehomica com Version 8 July 2015 User manual Version 8 July 2015 2 GEN MICA 1 TABLE OF CONTENTS 1 TABLE OF 65 3 2 PRINCIPLE OF OPERATION OF THE DEVICE 0 0 nenne 5 RIBE DII DON MM HHHH IMIMMMME 8 gt N N NN nHnBFHNHZEEERHHnH HEEHnHnEnEEEE NEnEnHENHEHnHE H HH H HH H E E EH nRN EH NEoTRMRDn 10 5 5 10 6 TRADING NAME OF THE PRODUCT AND REFERENCES eene 11 7 5 H MHHH MM 11 RN NINE HHH n HHHH MM 13 10 UNPACKING STORAGE AND PACKING c ceccccecceeecccesscceccceccececceesseecseectseeeuseeesseeeseeeers 15 11 ENVIRONMENTAL 6 0 serrer KAKA AKA 17 12 USAGE PRECAUTIONS
19. aning solution is not authorised User manual Version 8 July 2015 20 GEN MICA 15 CARING FOR THE DEVICE AFTER USE The instrument This device cannot be disposed of in public disposal systems In compliance with the European national and local regulations EU directive 2002 96 EC users of European electrical devices must return to the manufacturer any devices which are old or which have come to the end of their life cycle 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 Packaging Please keep the packaging material for the duration of the device s working life The packaging components cardboard polyethylene etc are products which are comparable with normal municipal solid waste so they can be disposed of without any difficulties In any case it is recommended to dispose of products separately selective collection in line with the standards in force for proper recycling DO NOT THROW THE PACKAGING PRODUCTS AWAY INTO THE ENVIRONMENT User manual Version 8 July 2015 21 GEN MICA 16 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
20. ation 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 User manual Version 8 July 2015 6 JO O gt LLI Visualization User manual GEN MICA Sample preparation DNA extraction and DNA Standard amplification labelling of targeted molecules laboratory equipment Specific hybridisation labelled sample incubation against AS chip Visualization conjugation and precipitation of the staining Colorimetric Detection and Analysis CAR CLINICAL ARRAY READER Version 8 July 2015 7 GEN MICA 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 CLART HPV2 CLART ENTHERPEX CLART EnteroBac CLART PneumoVir Pneumo CLART bacteria CLART STISA User manual OBJETIVE Detection and typing of human pap
21. aw Data To consult raw and normalized numerical values obtained in the analysis of the samples GEndmicr Array ID 00000000050208 1 Wed Jan 28 12 54 21 2015 IMAGEN EXPORTAR DATOS CRUDOZ User manual Version 8 July 2015 41 GeEnemicr Fig 24 Menu of results E a 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 Fig 26 This option only could selected in the non analysed Wells User manual Version 8 July 2015 42 GEN MICA Assay Mame CLART CMA 135c 14 Fig 26 Reanalize option in the initial men 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 27 Fig 27 Manual grid alignment in strips using metal markers and zoom tool The correct grid alignment consist in positioning the upper left marker over the upper left metal marker and then adjusting the whole grid size by using the lower right metal marker User manual Version 8 July
22. cemia Genotyping predisposing polymorphisms have genetically related to bone metabolism disorders Detection and identification of point mutations belonging to the path associated with colorectal cancer EGFR Detection and identification of point mutations belonging to the path associated with colorectal cancer EGFR Detection and genetic identification of Point mutations insertions and deletions in the gene EGFR pathway associated to non small cell lung cancer Version 8 July 2015 GEN MICA a generic detection of Chlamydia trachomatis for those cases in which the serotype is e CAR Clinical Array Reader not achieve Neisseria gonorrhoeae Mycoplasma genitalium and Trichomonas vaginalis Ureaplasma urealyticum parvum Mycoplasma hominis Candida e Amplification Reagents C albicans C glabrata C parapsilosis C krusei C tropicalis C guilliermondii C dubliniensis e Visualization Reagents Treponema pallidum Haemophilus ducreyi Herpes Virus types and Il Specific assay software Amplification Reagents Visualization Reagents Specific assay software Staphylococcus spp Streptococcus spp Enterococcus spp Cocos Gram positivos CGPs Listeria monocytogenes Clostridium perfringens Escherichia coli Klebsiella spp Salmonella ent rica Enterobacter spp Citrobacter spp Serratia spp Proteus spp Haemophilus spp Acinetobacter baumanii Bacteroides Pseudomonas Stenotrophomonas maltophilia Candida spp Amplification Reagen
23. der The software associates automatically a barcode to a sample position starting from position 1 on the upper left side of the plate Once finished with the setting of samples Ids Od to continue with the reading process Fig 18 User manual Version 8 July 2015 35 24 cGenemicm TI 09000000009 2000000000 3000000000 6 0 0 0000000000 0000000 C N Fig 18 Pantalla de inserci n 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 denon Muestras GEG WEG Fig 19 Setting Samples IDs Manually At the top left of the screen you can check the plate position of the sample This way you can keep track of samples already assigned New window with a keyboard will appear see images above Scroll the screen up and down and use the virtual keyboard to set the references manually User manual Version 8 July 2015 36 GEN MICA Once finished Od for getting back to the microtiter plate menu and from there MM 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
24. disconnection device rear part of the equipment Once installed the appliance must not be moved The assembly surface must be levelled in all directions in order to ensure the smooth operation of the device Make sure that the reader is installed on a totally horizontal stable surface If any operating anomalies are detected please get in touch with the technical assistance service and do not try to sort the problem out yourself Before connecting it to the mains make sure its voltage corresponds to 110 230 V AC a 50 60 Hz and earthing Do not install the reader near any intense source of light or heat Switches must never be touched with wet hands Turn off the appliance switches before unplugging from the mains User manual Version 8 July 2015 22 GEN MICA 17 INSTALATION Please follow the indications described in this manual to set up the CLINICAL ARRAY READER CAR 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 Remove these screws before switching on the instrument for the first time and keep them for the posterior assembling of the screen No special tools are required to remove both
25. ection 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 User manual Version 8 July 2015 19 GEN MICA 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 yu dr Tae Sil 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 cle
26. ective 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 User manual Version 8 July 2015 10 GEN MICA 6 TRADING NAME OF THE PRODUCT AND REFERENCES e CLINICAL ARRAY READER CAR e 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 1 x Screen Pantalla Tactil 1 x processing computer Ordenador de procesamiento 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 User manual Version 8 July 2015 11 GEN MICA If the user makes a mistake when choosing the software an error message appears in the results report Please recheck the analysis you wish to carry out and select the right one The software is updated on a regular basis to meet any new demands expand the applications or improve their
27. ellow CLART ENTHERPEX Once the number of AS or strips to process is selected press Q Fig 13 User manual Version 8 July 2015 31 Zela 24 x he O O O O O 900090002 0000000 00000000 00000000 F x GEnemicA 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 To desactivate them proceed to press on the symbole placed on the top of the Strip and it will turn into indicating the strip is unselected strip and the strip will appear on a light grey colour Fig 14 The Strip could be placed in a non correlative position but it is recommended User manual Version 8 July 2015 32 GEN MICA O assi 2 OQ 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 pres
28. ent 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 User manual Version 8 July 2015 16 GEN MICA 1 Turn the reader off completely and turn it off from any power supply 2 Put 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 its place Keep the original packaging materials Any instruments returned for their recycling repair must be sent in the original packaging material to protect them from any damage during transport 11 ENVIRONMENTAL CONDITIONS Optimum storage conditions Optimum temperature Relative Humidity between 5 and 402 C 10 75 Optimum operating conditions for use at the laboratory interiors Relative Pressure Ventilation and cooling conditions Temperature Humidity A space of 10 cm must be kept free 700 1200 hPa in front of the device to ensure 15 40 10 75 less than movement of the plate A free space of 5 cm is also required at the rear of the equipment for sea level ventilation 2000m above User manual Version 8 Jul
29. he reader directly by using the rear switcher it produces irreversible damages on the CAR system User manual Version 8 July 2015 27 d Gen micr NUEVO ANALISIS HIST RICO CONFIGURACI N Fig 8 Switer at the main men 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 19 READING PROCESS CLART Strips Reading and analyzing samples is a sequential easy procedure compose by multiple menus where user can choose among the several options of the application In order to start new analysis choose option New Analysis on the application s main menu Fig 9 User manual Version 8 July 2015 28 GEN MICA O NUEVO AN LISIS j CONFIGURACION s 9 Fig 9 Selecting New Analysis option at the main menu Once this option is selected a new menu will pop up on the screen where 96 wells microplate sketch is depicted Fig 10 ed zara pu ENSAYOS AUTO MUESTRAS 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 e Set rack type choose between 96 wells microtiter plate CS or tubes adaptor e Set the
30. illomavirus 2 Detection and typing of Herpes and Enterovirus Detection and identification of genetic Enterobacteriaceae causing diarrhea Characterization of virus causing human respiratory viral infections Characterization of virus causing human respiratory bacterial infections Detection and identification of pathogens Version 8 July 2015 TARGETS FOR DIAGNOSIS Human Papillomavirus 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 HSV 1 HSV 2 VZV CMV EBV HHV 6 HHV 7 HHV 8 Poliovirus Echovirus y Coxsackievirus spp 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 enterocol tica Campylobacter spp C lari C laridis C upsaliensis C jejuni C coli Campylobacter jejuni Campylobacter coli Escherichia coli enteropathogenic EPEC E coli enterohemoragic E coli enteroinvasive E coli enterotoxigenic and E coli enteropathogenic Clostridium difficile B and Aeromonas spp producers of aerolisin Adenovirus Bocavirus Coronavirus Enterovirus Echovirus Influenza virus A subtypes H3N2 human H1N1 human B C and H1N1 2009 Metapneumovirus subtypes A and Parainfluenza virus 1 2 3 and 4 subtypes A y Rhinovirus Respiratory
31. justar manualmente la fecha y hora del lector Insert both data export and backup path Language only English Spanish French and Greek are available e Default Assay other from HPV2 4 me n T EE Versi n 1 0 3 N m serie ARO01 01 0374 Ultima calibraci n 6006060 Hora 95 0 BACKUP Exportaci n CActEISDataExpot C CLEIS Data Backup Ww INSTALL UPDATE l Q MANAGEMENT Idioma EAAnvIKG SY YSTEM SETTINGS Por defecto HPV2 8sc 8 CLART 4 135 9 CLART_METABONE_5 3 CLART STIs 10sc 11 Fig 60a Setting option Fig 60b date backup path language Default Assay User manual Version 8 July 2015 50 GEN MICA 21 FREQUENTLY ASKED QUESTIONS FAQ 1 SOFTWARE UPDATING AND INSTALLATION 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 Check that within the root directory and not in any other of your USB memory you have the Zip files we sent you 217 qe gt Equipo VERBATIM E Organizar Compartir v Nueva carpeta Documentos Imagenes genes jj CLART SEPTIBAC T1 8sc 2 140923 CAR zip
32. 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 User manual Version 8 July 2015 15 GEN MICA 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 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 drag 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 ev
33. n green Sample already analyzed Grid alignment agreed e Wells in red Sample may be reanalyzed Grid alignment failed see Sample Reanalyze next section Wells in yellow Sample has not been analyzed yet ea Placa 2015 01 28 12 51 27 Run ID 138 20006006000 o0000000 e 6 0 e 8 amp 0 0 e 0 9 e User manual Version 8 July 2015 39 GEN MICA Fig 22 Reading process monitoring Wells appearing in Green Sample already analyzed red Sample may be reanalyzed and light yellow Sample has not been analyzed yet Unselected strips remain in light grey color 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 e Date and time Position of the sample Assay ID Sample ID Results obtained User can look up the final report by selecting Run Report option And it could be printed as a PDF format from the same men Fig 23 as long as a printer is connected to the device See FAQs GEndmicr RunID 2015 01 28 12 53 32 138 Fecha y hora Wed Jan 28 12 53 39 2015 50208 CLART HPV2 00000000050208 died Teen 4 2 canas P Tipo 18 Tipo 33 Tipo 59 Tipo 6 502 2 000000000502 1 3 50208
34. n 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 User manual Version 8 July 2015 5 GEN MICA LED 99 L 3 Diffusor r CCD Camera 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 interpret
35. nd or updating assays software B System settings allows the user to change language export and backup paths date C Back up for saving or copy results stored at the reader s data base 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 on the menu In order to uninstall any software select it from those listed on the screen and press Delete The uninstalled software will be erased from the list but it will be registered on the Version Management option upcoming section Fig 56 User manual Version 8 July 2015 47 GENE MICA 4 Esta tabla muestra los ensayos actualmente instalados en equipo Pulse Instalar para a adir o actualizar el software o Eliminar para desinstalarlo Instalar Eliminar Cerrar Va instalar CLART ENTHERPEX 8sc 1 130529 CAR zip Est seguro VERSION INSTALL UPDATE MANAGEMENT SYSTEM SETTINGS Fig 56a Selecci n de Instalar en el Fig 56b Men de selecci n de kits a submen Servicio instalar B SYSTEM SETTINGS System settings option allows the user to personalize the interfaces and perfo
36. os procesos de apertura y cierre de la bandeja del lector Fig 20 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 E a Placa 2015 01 28 11 47 18 e e amp 0 e 0 0 0 e amp amp 0 e 0 0 0 P M J T Di i AE J 3 P 2 3 ut ABRIR BANDEJA Fig 20 Open tray displayed by the application Once finished the opening process place the microplate manually in the tray and operate the Close Tray icon Fig 21 User manual Version 8 July 2015 38 GEnemicA 2015 01 28 11 48 15 00060600600 o0000000Q o0000000 e 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 Fig 22 e Wells i
37. rmance characteristics Fig 57 A Versi n 1 0 3 N m serie AR01 01 0374 ltima calibraci n 9566970099 6 a Exportaci n cnctEISIDataExpot SS 4 Na ee O d Backup _C CLEIS Data Backup VERSION C MANAGEMENT Idioma YT ce SYSTEM SETTINGS I ET ET Por defecto 2 8sc 8 CLART_HPV4_13sc 9 CLART_METABONE_5 3 CLART STIs B 10sc 11 Fig 57b Software sets English as default language Select the most suitable language from those listed on the screen by using the scroll buttons Fig 57a Select Sistem Setting C BACKUP Backup option allows the user to perform a security copy of the data stored in a external device or could be sent to the LIMS of the laboratory User manual Version 8 July 2015 48 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 How can change the the backup path User can change the backup path at any time on the Settings menu o Versi n 1 0 3 N m serie ARO01 01 0374
38. s thel button on the New Analysis submenu placed on top of each strip you want to analyze Opci n activates a new window that lets the user choose among those assays shown in the pull down menu Fig 15 Selec the essay for strip number X User manual Version 8 July 2015 33 GEN MICA 27 ey Select Assay ID for Strip 1 CLART HPV2 8 08 Fig 15 Manual insertion of the essay references Press 0 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 34 GEN MICA 1 lI ae 26 3E 168206006000 amp e amp 0 e 0 0 0 e PLACA ENSAYOS AUTO MUESTRAS 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 Setting Samples IDs Automaticall Press Set Samples Ids on the microtiter plate sketch menu and read the previously assigned barcodes normally with a barcode rea
39. ssistance C windows system32 cmd exe 10 x patch Genomica Scripts runre port error html patch Genomica Scripts runre port Npatch Genomica Scripts Nvorkinglist error html patch GenomicaN Scripts workinglist py patch GenomicaN Scripts workinglist tmp html patch Genomica Scripts workinglist voc 1 33 patch Genomica Scripts workinglist voc 1034 8 1 lt 5 gt copied patch Sensovat ion CLART_HPU2 12Ger with 5 CircleRefs svary patch Sensovat ion CLART_HPU2 Algorithm svalg patch Sensovat ion CLART_HPU2 CLART_HPU2 svexp patch Sensovation Metabone i2Qer with 5 CircleRefs svary patch Sensovation Metabone Algorithm svalg patch Sensovation Metabone Metabone svexp patch Sensovat ion Pneumovirsi2Ber with 5 SquareRefs svary patch Sensovat ion PneumovirsA lgorithm svalg patch Sensovat ion Pneumovir Pneumovir svexp File lt s gt copied CLART 2 install ok Please restart the reader for changes to take effect 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 option on the main menu of the application and go to System Set up ewe Versi n 1 0 3 Num serie 01 01 0374 Ultima calibraci n Q
40. ts Visualization Reagents Specific assay software Polymorphisms detected collagen type 1 vitamin D receptor and estrogen and calcitonin receptor Amplification Reagents Visualization Reagents Specific assay software NRAS I KRAS Amplification Reagents Visualization Reagents Specific assay software KRAS BRAF Y PI3K Amplification Reagents Visualization Reagents Specific assay software GEN MICA 4 USE 5 gt IN VITRO DIAGNOSTIC MEDICAL DEVICE The CLINICAL ARRAY READER CAR is to be used exclusively with the reactive agents supplied by GENOMICA Follow the usage instructions carefully Please 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 knowledge unless they are acting under the surveillance of someone responsible for their safety or they have received instructions about the use of the appliance Using 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 Dir
41. y 2015 17 GEN MICA 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 User manual Version 8 July 2015 18 GEN MICA 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 Do not try to open or force the external prot
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