True
AUTO
prep
v2
User Manual
603042001
REF
IVD
Universal Cartridge Based
Sample Prep Device
®
Trueprep
Page 1: ...True AUTO prep v2 User Manual 603042001 REF IVD Universal Cartridge Based Sample Prep Device Trueprep AUTO v2 ...
Page 2: ...provided with device 5 6 The Trueprep AUTO v2 5 6 1 A Top Panel View 5 6 1B Back Panel View 6 6 2 The Cartridge 6 7 Using the Trueprep AUTO v2 7 7 1 Charging Using the Trueprep AUTO v2 with the AC Adapter 7 7 2 Plugging in the reagent bottles 8 7 3 Switching ON OFF the Trueprep AUTO v2 11 7 4 Placing the Cartridge in the device and starting the run 11 8 Errors Alerts and Maintenance 14 8 1 Error M...
Page 3: ...eagent Reset Card for 50Tests Pack size 10 Figure 10 The cartridge holder opened after eject button is pressed 11 Figure 11 Cartridge being placed in cartridge holder 12 Figure 12 Cartridge placed in cartridge holder in correct orientation 12 Figure 13 Replaceable tray in cartridge holder 13 Figure 14 Removal of Replaceable Tray from cartridge holder 13 Figure 15 Replacement of discarded Replaceab...
Page 4: ...nd does not require highly skilled personnel to carry out the extraction process All the waste from processing of the sample is contained within the cartridge dump area thus posing no risk from potentially bio hazardousmaterial Thedevicehasauniversalprotocolandcanworkwithallkindsofsamplessuchassputum BAL whole blood serum plasma tissue stool urine CSF pleural fluid lymph node aspirate pus peritone...
Page 5: ...condensing Theunitshouldbestoredonaflat drysurface 3 Specifications AUTOv2complieswiththeemissionandimmunityrequirementsdescribedinIEC61326 Trueprep series 4 Precautions CheckforLowBatterybeforeusingtheTrueprep AUTOv2 seesection7 1 Insertandremovethecartridgegentlyfromtheholder useofexcessiveforcecoulddamage it Donotspillliquidsinsidethecartridgeholder Do not perform an extraction in the presence ...
Page 6: ...ith Trueprep AUTO AUTOv2UniversalCartridgeBasedSamplePrepKit REF60203AR25 REF60207AR50 consistingof UniversalReagentPack 25 50tests UniversalCartridgePack 25 50Nos Disposabletransferpipettegraduated 25x3ml 50x3ml Packageinsert 1No 6 TheTrueprep AUTOv2 6 1A Top PanelView Figure 1 The Trueprep AUTO v2 Top View with cartridge holder shown in the front panel ThePowerbuttonswitchesonandswitchesofftheTr...
Page 7: ...luewhentheTrueprep AUTOv2isbeingcharged 6 1B BackPanelView Figure 2 The Trueprep AUTO v2 device Back Panel with Reagent Pack of the Trueprep AUTO v2 Universal Cartridge Based Sample Prep Kit 6 2 TheCartridge Samples are processed on disposable single use cartridges that are inserted into the cartridge holder These cartridges come pre loaded with Internal Positive Control and only require the addit...
Page 8: ... and you will also hear a beeping sound TheTrueprep AUTOv2devicecannotbegina newrunifthebatteryislow Fig 4 Low battery LED glowing red 7 1 3 Ifthebatterychargeisfullorsufficienttocarryoutarun theCharging LowBatteryLEDIndicator willstayoff YoumayproceedtouseTrueprep AUTOv2onbatterycharge For charging or to use Trueprep AUTO v2 on mains connect the ACAdapter to the Charging Portontherightsideoftheba...
Page 9: ...ACAdapterunlessitisbeingusedtopowerthedevice Figure 6 The Blue Charging LED Indicator Glowing 7 2 PluggingintheReagentBottlePackof25TorReagentPackof50T 7 2 1 PluggingintheReagentBottlePackof25Tpacksize 1 Beforestartingarunforthefirsttime pluginthecolourcodedreagentbottlesfromtheTrueprep AUTO Sample Prep Kit Reagent Pack into the back panel of the device matching the colour of the cap on the panel ...
Page 10: ...ugging in the reagent pack of 50T pack size 1 Before starting a run for the first time plug in the reagent pack from the Trueprep AUTO v2 Sample Prep Kit to the backside of the device Figure 8 Discard the used reagent pack in a propermanner 2 The device will prompt when 50 tests have been completed and the reagent pack have to be replacedbyfollowingbufferresettingprocedureasperPointNo 7 2 5 1or7 2...
Page 11: ...l be displayed on screen alternatively once buffer count reaches 50 Press Eject insert Reagent Reset Card provided with the new Reagent pack close the tray and press start Once the buffer count has reset to zero following will be displayed on screen BY PRESSING START EJECT SW SHUTTING DOWN CHANGE REAGENT PACK RESET SHUTTING DOWN SETTINGS SAVED SHUTTING DOWN INSERT REAGENT RESET CARD START SHUTTING...
Page 12: ...ingscreenwillbedisplayed releasethepowerbutton Thedevicewillturnoffautomaticallywithin30seconds 7 4 PlacingtheCartridgeinthedeviceandstartingtherun Important Onlyusethecartridgeprovidedinthecorrespondingsampleprepkits 7 4 1 PresstheEjectbuttontoopenthecartridgeholder Youwillbepromptedwiththemessage 11 TRUEPREP AUTO BUFFER COUNT SHUTTING DOWN INSERT CARTRIDGE Figure10 Thecartridgeholderopenedaftere...
Page 13: ...idge holder to remain open andthecartridgewillnotbeinsertedinthedevice Figure 11 Cartridge being placed in cartridge holder 7 4 3 Push the cartridge holder gently inwards to close it shut Press the Start Button to proceed This is the start of the Trueprep AUTO v2 sample preparation process After reading the QR code of Cartridge Extraction process starts If the QR code is read then the same cartrid...
Page 14: ...dge holder as shown in the Figure 14 Replaceable Step 2 Placement of the tray 2a Place the tray in cartridge holder as shown in Figure 15 Replaceable i Inspect the tray in the cartridge holder Replaceable ii If there are liquids spilled in the tray take out the tray and discard as per the instructions in Section8 3 iii Cleanthecartridgeholderwith70 IsopropylAlcohol IPA asdescribedinSection8 3 iv R...
Page 15: ...on PressEjecttoexit alternatively Solution Contact Molbio s support team E1 CARTRIDGE VALVE ERROR Press Eject to exit E2 CARTRIDGE ERROR The Screen displays the error message E2 CARTRIDGE ERROR and instruction PressEjecttoexit alternatively Solution Contact Molbio s support team The Screen displays the error message E3 CARTRIDGECLOGGED and instruction PressEjecttoexit alternatively Solution Contac...
Page 16: ...ate of cartridge The Screen displays the error message E6 CARTRIDGE NOT LOADED and instruction PressEjecttoexit alternatively Solution Contact Molbio s support team Press Eject to exit E6 CARTRIDGE NOT LOADED Press Eject to exit Reagent Pack Errors and Warnings E7 E8 E7 EXPIRED RESET CARD The Screen displays the error message E7 EXPIRED RESET CARD and instruction Press Eject to exit alternatively ...
Page 17: ...W1 SBC NOT Responding Reagent Pack Errors and Warnings E11 E11 RTD L ERROR E12 The Screen displays the error message E12 RTD E ERROR Note This is for Elution Heater E11 RTD E ERROR Device Errors and warnings E11 The Screen displays the error message E11 RTD L ERROR Note This is for Lysis Heater Solution Contact Molbio s support team E11 RTD L ERROR E12 The Screen displays the error message E12 RTD...
Page 18: ...ld Start Button and Power Button on the Trueprep AUTO v2 Firmware Version and Total run status counts will be displayed on the screen as given below Ÿ Release both the buttons when following is displayed Ÿ In themenu thefirstlineofLCDdisplayshowsdifferentfunctionoptions Thesecondlinedisplays navigating options for next Eject Button and back Start Button The Power Button allows selectionofcurrently...
Page 19: ...e it is selected tray will be ejected Following screens will toggle with 2 seconds interval Ÿ Insert cartridge and press start the flushing process will begin Ÿ The cartridge will be ejected once flushing is completed following will be displayed on screen and device will go back to menu Ÿ Press Power button to exit without flushing EXIT OK EXIT OK EXIT OK CONNECT DISTILLED WATER Trueprep AUTO v2 E...
Page 20: ...eshly prepared 0 5 Sodium Hypochlorite solutionandacleanclothortissue Thisshouldbedoneonceeverydayand orwhenthedeviceis movedtoadifferentworkspace 8 3 3Spills If you notice a spill in the tray placed in the cartridge holder dispose the tray Clean Replaceable the insides of the cartridge holder with clean cloth or tissue or swab dipped in 70 Isopropyl Alcohol IPA Waitfor5minutesbeforeinsertinganew ...
Page 21: ...20 In Vitro Diagnostic Medical Device Trueprep AUTO v2 ...
Page 22: ... FRAGILE KEEP DRY Fully automatic operation Rapid sample prepping Mains rechargeable battery powered AUTO v2 Universal Cartridge Based Sample Prep Kit Portable This Side Up Medical Electronic Rush Do Not Stack Fragile Keep Dry True prep Trueprep AUTO v2 ...
Page 23: ... Registered Office Manufacturing Unit Plot No L 46 Phase II D Verna Industrial Estate Verna Goa 403 722 INDIA www molbiodiagnostics com Molbio Diagnostics Private Limited Qarad EC REP b v b a Pas 257 B 2440 Geel Belgium ...
