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1. Assay peri MTE RiF Assay Assay pen MTB FrF Asay xpert MTE RIF Assay pert Assay pert MTB RiF Assay pen Assay aman 2 181813 19 09 12 181344 18 09 12 181737 19 035 2181008 19 091 2 08 17 06 141047 20813748 2072901 18 09 12 07 23 58 170512 01 15 28 1005 12 01 15 00 2 01 1427 1 OS 01 11 33 180872011626 14 05 12 04 4556 04 45 08 TURSA I 044423 104012 03 37 18 UDST2033801 11 08 12 013817 1 06 12 03 34 48 10 051 2 01 07 20 01 06 28 View results gt GeneXpert amp Dx System di User Data Management Reports Setup View Results About User None M M M Information Check Status Stop Test View Results Define Assays Define Graphs Maintenance about the test A2 Views Result View TestResul Analyte Res lt Detail Errors History Support 134723 1 Primary Curve 1 Assay Name Xpert MTB RIF Version 1 Test Result ERY LOW Assay pert MTB RIF f ics Use Only Interpretation of Version 1 the Result 7 Real Time PCR curves Test Type Specimen v Sample Type Other v Other Sample Type Notes Legend Probe D Primary Probe C Primary v Probe E Primary Start Time 14 05 09 12 03 36 E Z Probe B Primary e SPC Pri
2. d _ Result View 2 7 Probe D Primary Other Sample Type _ Primary Curve v Probe C Primary 300 vi Probe E Primary 2 Probe B Primary Notes 2 im NT vi SPC Primary 2 p dd Vi Z Probe A Primary E Z QC 1 Primary 100 yc QC 2 Primary 22 ra Start Time 03 17 13 22 54 15 A BEP a End Time 03 18 13 00 34 40 ES 10 20 30 40 Cycles Status Done User lt gt v Export Report View Test 27 Cepheid Proprietary amp Confidential C Cepheid GeneXpert software configuration version 4 4 Generate a result report in pdf N 5 4 28 Cepheid Proprietary amp Confidential Generate result report pdf format D gt User Data Management Reports Setup View Results About N f y a Check Status Stop Test View Results Define Assays Define Graphs Maintenance Click on VIEW RESULT Patient ID I Test Result blabal Result View Assay Name Xpert MTB RIF G3 Version 3 Primary Curve Test Result Sample ID Resistance NOT DETECTED Assay Xpert MTB RIF G3 For In Vitro Diagnostics Use Only Version 3 Reagent Lot ID 02806 J Test Type Specimen v Sample Type Other v CC Other Sample Typ
3. Rif Resistance DETECTED Sample ID Test Result Open E3 Select the file you want to m Ne retrieve 12011 GeneXpert 2011 08 11 09 15 52 9xx File Name Click on Open Files of Type p 7 Open Cancel 42 O Cepheid Proprietary amp Confidential ZA How to retrieve results Select Test s To Be Retrieved From GeneXpert PC 2011 08 11 09 15 52 gxx Select All _ ae ae Select the test you may want to retrieve or Select All DETECXpert MTB RIF G3 MTB DETECTED MTB RIF G3 MTB DETECTED MTB RIF G3 08 10 11 2 12 24 PM 08 08 11 4 49 10 PM 08 08 11 4 46 21 PM 5 Click OK Retrieve lest s total of 1test s been selected This will retrieve the selected test s into the main database Would you like to continue Click Proceed Retrieve lest s 1 test s successfully retrieved Retrieval details are logged C GeneXpert Database log Retrieve log 2011 08 11 11 26 01 txt 7 43 Cepheid Proprietary Confidential Z Cepheid GeneXper DX Software version 4 4 How to backup the data 44 Cepheid Proprietary amp Confidential C Cepheid Data management tasks At the end of the working day while closing the paamanogemom Reports About SSIES GeneXpert software
4. Probe E Primary 1 Vi Z Probe B Primary Notes 2 vi SPC Primary vi Probe A Primary Fluorescence vi 7 QC 1 Primary vi Z QC 2 Primary C 2 Start Time 03 17 13 22 54 15 End Time 03 18 13 00 34 40 Status Done E Changes IE Repo 1 20 30 40 Cycles After editing click Save Changes Select Graphs View Test 26 Cepheid Proprietary amp Confidential Edit test related info sample id Save Test Click Yes to confirm the changes Yes No Cancel gt GeneXpert amp Dx System gt fx User Data Management Reports Setup View Results About User Kristians The history of the changed e history o e change x V Create Test Check Status Stop Test View Results Define Assz Define Graphs Maintenance information is saved under 411 2 Module 4 4 4 the tab Histo z Views Test Result Analyte Result Detail History S pport Z Result View Field Name WAS 5 User Time 9 19 Notes EXAMPLE Kristians 06 03 13 13 14 19 Sample ID 7 Assay pert MTB RIF As say G4 Version 5 Reagent Lot ID 11012 Test Type Specimen 2 2 Views _ Legend Sample
5. Select Test s To Be Archived Select All Deselect All Select Highlighted Deselect Select New p Delete Archived Highlighted Archive Tests Put the mouse cursor on first OW ME 12 3773 ADM None DETECTED Xpert MTE RIF AssayG4 Done 03 25 13 02 38 27 test d h d th e left mouse 13 3774 None DETECTED Xpert MTE RIF AssayG4 03 25 13 02 37 50 13 3830 4 one DETECTED XpertMTB RIFAssayG4 Done 03 25 13 02 37 23 b utton 13 3775 A3 c None DETECTED XpertMTB RIFAssayG4 Done 03 25 13 00 51 33 13 3778 A2 one MTB DETECTED XpertMTB RIFAssayG4 Done 03 25 13 00 51 09 Drag the mouse down ntil the 113 3810 None DETECTED Xpert MTB RIF AssayG4 Done 03 25 13 00 50 47 13 3792 Ad None DETECTED XpertMTB RIFAssayG4 Done 03 25 13 00 50 15 last Ine 13 3748 A3 None DETECTED L Xpert MTB RIF AssayG4 Done OK 03 24 13 23 01 36 13 3765 A2 None DETECT Xpert MTB RIF AssayG4 Done 03 24 13 23 01 00 13 3763 None NOT DETECT Xpert MTB RIF AssayG4 Done 03 24 13 23 00 38 13 3764 Ad None DETECT Xpert MTB RIF AssayG4 Done 03 24 13 23 00 11 32 3781 A3 None DETECT Xpert MTB RIF AssayG4 Done OK 03 24 13 21 06 57 1
6. Motes Rear ot ID The module will be automatically selected DO NOT CHANGE IT Fully close the module door the test starts Click on Start Test immediately Wait 2 hours to see result s L aoe 9 17 Cepheid Proprietary amp Confidential GeneXper DX Software version 4 4 How to stop atest and why 18 Cepheid Proprietary amp Confidential C Cepheid How to stop test and why In case vour cartridge s was were not properly prepared vou might have to stop the test to avoid waist of time GeneXpert Dx System DER a S CI Sto st Maintenance Create Test Check Status Test View Results Define Assays Define Graphs Module Name 2 Assay Xpert M Version 1 gt Stop Test Select the module s that Modules Module Remaining Progress Status need to be stopped by Name Test Time xpert MTB RIF Assay G4 Xpert M TE 3160400 sample Prep 1 50 14 marking the tickbox 3 After selecting click Stop 19 Cepheid Proprietary amp Confidential ZA How to stop a test and why Remaining Test Time Module Name Confirm your choice by clicking Yes Stop Cancel 5 You will see the stopped test s details in Check Status section GeneXpert amp Dx System User Data Management Reports Define Graphs Maintenanc
7. ser IE temp Preview PDF will open the pdf file File Name Specimen Report 2013 05 03 14 04 02 pdf iles e GeneXpe ort Files u mE LI MN NN Generate Report File will save the report in GeneXpert Folder gt Report 33 Cepheid Proprietary amp Confidential GeneXpert DX Software version 4 4 How to print automatically test report 34 Cepheid Proprietary amp Confidential C Cepheid How to print automatically test report Connect and install your printer ae You can print every report once test is sem 310 finished NN A Create Test EI Module Sample ID Remaining Test Time Sample Progress Status ID 1 Click on Setup then System configuration System Configuration EJ General System Name Genexpert Date Format Time Format 24 Hour HH mm ss Use Patient ID Scan Patient ID Barcode v Scan Sample ID Barcode vi Scan Cartridge Barcode Require Start Test Login C Never Always 2 Start Test Login Timeout In Minutes 30 vj Audio At End Of Test Print Test Report At End of Test Assay Statistics Deletion Reminder Exclude Modules From Test Select Modules 2 Select the appropriate option Print Test Report At End of T
8. Basic 3 Click on OK Remarks The basic access will only be able to see the results without the graphics 11 Cepheid Proprietary amp Confidential Routine use Create a test 12 Cepheid Proprietary amp Confidential C Cepheid Create a test 1 Click on CREATE TEST A dialogue box will appear Please scan cartridge barcode 1 Dx System Scan Cartridge Barcode User gement Trending Setup Please scan cartridge barcode n lt i A Create Test Check Status Modules Manual Entry Cancel 13 Cepheid Proprietary amp Confidential Press the yellow button of the barcode scanner and scan the cartridge Create a test Once done the below screen will appear m A green light will blink from a zl d Create Test given module Open the door available and place the cartridge Patient ID Sample Name 5 Fill in the Sample ID Select xpert MTB RIF G3 Select Modul A1 ReanctLotID 12512 Expiration Date C specimen 07 The module will be Sample Type ome Other Sample automatically selected DO NOT CHANGE IT Motes s Fully close the module door the test starts lick on rt T immediately o hn Wait 2 hour to see yo result 14 Cepheid Proprietary 8 Confidential C Cepheid Routine use Manua
9. GeneXpert Infinity Systems 5 Xpert MTB RIF Assay G4 5 gxa File Name File Name Files of Type Assay Files Files of Type Assay Files qxa w p W Click on IMPORT 53 Cepheid Proprietary amp Confidential Import the Assay Definition File ADF Now vou can work with the new Assay Definition File It will be showed here a GeneXpert Dx System m X User Data Management Reports Setu Define As a 5 About User lt gt Create Test Che Status Stopa est View Results Define Assays Define Graphs Maintenance po Assay Name Xpert MIB RIF Assay G4 Name Version 5 Xpert MTB RIF G3 3 Xpert MTB RIF Assay 5 Assay Type in Vitro Diagnostic Far In Vitro Diagnostic Use Only Assay Disclaimer Meed Lot Specific Parameters Last Modified Date 11 10 11 11 11 50 Cartridge Chambers 54 Cepheid Proprietary 8 Confidential ZA GeneXper DX Software version 4 4 How to copy paste data to excel N 5 4 How to copy paste data to excel Click Data Managemen Archive Test Retrieve Test a u Create Test Check Status Stop Test View Results Define Assays Define Graphs Click Archive test Module Name X1 Views Ni Test Result Analyte Result Detail Errors History Support Patient ID Result View Primary Curve Assay Name MTB RIF G2 Version 2 sp Sample ID 21
10. amp Confidential Database Restore Please wait Restore in process Database Restore Restore process completed Your Dx System is ready to restart GeneXpert DX Software version 4 4 Import the Assay Definition File ADF N 5 4 Import the Assay Definition File ADF In case of test update you have to Import the ADF on the software Before using this lot load it from the CD provided with each kit Insert the CD on the Computer CD drive 1 Click DEFINE ASSAYS gt GeneXpert Dx System User DataManagement Reports Setup Define Assays About it y Lookin E My Documents C 1 Computer Infinity Shared Documents Need Lot Specific Parameters Last Modified Date 09 08 70 70 25 57 My Documents 3 71001647 V03 D My Network Places Ci GeneXpert Folder File Files of AssayFles gxa Import Cancel 2 Click IMPORT 52 Cepheid Proprietary amp Confidential E rei Import the Assay Definition File ADF 4 Open the folder GeneXpert Infinity 5 Choose the Xpert MTB RIF gxa file Systems 5 Import Assay E3 gt Import Assay Lookin amp 71001647 VO D E l Look In C GeneXpert Infinity Systems DJ CGXMTB RIF 10 Package Inserts DI CGXMTB RIF 50 Package Inserts
11. Probe 252 224 0 POS PASS 0 R2 20869 C3 jjacohj INVALID Xpert MTE RIF G2 Done OK 10440023801 Probe 24 1 326 0 POS PASS MTE ATCC 25177 jacobj MTB DETECT Xpert MTB RIF G2 Done OK 10 13 10 23 50 21 Probe 251 1720 POS PASS Li R2 13883 jacobj MTB DETECT Xpert MTB RIF G2 10 1310 02 34 30 Prahe B 256 1820 POS PASS Li R2 18782 jacobj MTB DETECT Xpert MTB RIF G2 10 12 10 02 59 46 SPC 7 4250 PASS Li R2 18715 Jacobi DETECT MTB RIF G2 Done OK 10 07 10 02 43 30 i 4 gt 45 0 g R1 72066 ALISHA MTB DETECT MTB RIF G2 09 09 10 09 34 52 v Proba 23 2140 POS PASS User B laboratory technician Status Start Time 20 12 11 11 59 46 Reagent Lot ID 02806 End Time 20 12 11 13 48 17 Expiration Date 12 08 12 Module Name 3 Cartridge sN 33666408 Module S N 509800 SAN Version 4 c Instrument S N 706393 Notes Error Status OK Errors 4 Click on Preview pdf for None immediate vizualisation For In Vitro Diagnostics Use Only N 30 Cepheid Proprietary amp Confidential Cepheid GeneXper DX Software version 4 4 How to generate specimen and patient reports in pdf 31 Cepheid Proprietary amp Confidential C Cepheid How to generate specimen and patient reports in pdf 2 Fillin the Sample ID Specimen Report GeneXpert amp Dx System Date Range User Data Managemer A
12. you will have the Nii Ta qu 1 2 following screen 7 Y 2 Qd Ve S Create Test Check Status Stop Test View Results Define Assays Define Graphs Maintenance Modules Tests Since Launch Module Remaining Start ie k m ES Name ID Test Time ID Name Status Date gt Database Management Select task click Proceed to continue Backup 2 Database Restore 2 Click Database Backup 45 Cepheid Proprietary amp Confidential Compact Database J Check Database Integrity Click on Proceed How to Create Backup The software will create a zip file with all the results gt Database Backup alela 3 GeneXpert PC 2013 04 02 15 28 07 GX 1 5 0 zip The file is saved on the desktop in the GeneXpert folder Backup section File Name Genexpert PC 2013 04 22 11 41 55 GX 1 5 0 zip Files of Type Database Backup Files zip p Click on SAVE 4 5 Click OK 46 Cepheid Proprietary amp Confidential GeneXper DX Software version 4 4 How to restore data from a backup N 5 4 How to restore data 5 User None In case of computer failure you might have to restore your data after reinstallation of all system Create Test Check Status Stop Test Define Assays Define Graphs Tests Since L
13. 3 3760 A2 None NOT DETECT Xpert MTB RIF AssayG4 Done 03 24 13 21 06 33 113 3759 None NOT DETECT Xpert MTB RIF AssayG4 Done OK 03 24 13 21 06 09 13 3758 4 7 None NOT DETECT Xpert MTB RIF Assay G4 Done OK 03 24 13 21 05 44 13 3721 ones MTB DETECTED V Xpert MTB RIF Assay G4 Done OK 03 23 13 01 51 58 While the lines marked Dress 13 3726 2 None DETECTED Xpert MTB RIF Assay G4 Done OK 03 23 13 01 51 32 123732 A1 e MTB DETECTED XperMTE RIFAssayG4 Done OK 03 23 13 01 51 07 tr C at th TI O n 13 3734 A4 None MTB DETECTED Xpert MTB RIF Assay G4 Done OK 03 23 13 01 50 44 12 3733 A3 None MTB DETECTED XperMTE RIFAssayG4 Done OK 03 23 13 00 09 23 your keyboard NETT 12 e MTE DETECTED L ne MTE RIF AssavG4 Done ok laaa 0008 Cancel 56 Cepheid Proprietary amp Confidential ZA How to copy paste data to excel Click the right mouse button and in the menu and choose Match destination Formatting gt click on it see below Open MS Excel by clicking Start gt All Programs gt Microsoft Office gt Microsoft The chosen results will be pasted in excel sheet Excel 2010 a My Compute T Set Program Access and Defaults k Windows Catalog x d 9 Booki Mic g Windows Update Dach Ho nsert
14. GeneXpert Software 4 4 version 2012 Cepheid a Cepheid Start the Windows Operating System Windows 1 generation 1 Switch on the GeneXpert a small blue light will appear at the front panel of the system 2 Switch on the Computer pu 3 Open the Windows XP session Username Cepheid Password cphc f Turn off computer P 4 P P A AA if d F Cepheid gt Cepheid 2 Cepheid Proprietary 8 Confidential Start the Windows Operating System Windows 7 274 generation 1 Switch on the GeneXpert a small blue light will appear at the front panel of the system 2 Switch on the Computer 3 Open the Windows 7 session Select the Username Cepheid and Type the password cphd 7 Cepheid d ta 3 Cepheid Proprietary amp Confidential C pheid techsupport ceppe Admin E rei When you will start the program the question Do you want to perform database management task will appear Click on NO when you begin your working day 5 In the Check Status screen verify that all modules are available If modules are not available please refer to chapter 11 of the Operator Manual and contact Cepheid technical support leg User lt None gt Create Test Check Status Stop Test View Results Define Assays Define Graphs Maintenance User Data Management R Abo
15. Page Layout Formula Data Review View My Documents Cu zu Calib 11 gg Wra Genera Games 53 BZU EE Merge amp Ce 5 Microsoft Office Microsoft Office 2010 Tools 4 Roxio Creator Starter Microsoft Excel 2010 EE Startup Microsoft OneNote 2010 dobe Reader 9 Microsoft Outlook 2010 1 G P 242 13 3773 DETE Xpert MTE Done Internet Expro Mio gt werPoint 2010 2 Done G P 240 13 3830 DETE Xpert Microsoft Virtual Microsoft Word 2010 3 G P 239 13 3775 MTB DETE Xpert MTE Done MSN G P 238 13 3778 MTB DETE Xpert MTEDone Outlook Express 4 G P 237 13 3810 MTB DETE Xpert MTE Done P G P 236 13 3792 DETE Xpert MTE Done E mail Pee 6 235 13 3748 DETE Xpert MTE Done M Windows Media Player 6 G EP 266 13 3765 MTB NOT Xpert MTE Done ind G EP 265 13 3763 MTB NOT Xpert MTE Done AWU microsoft word 2010 Windows Messenger 7 G EP 264 13 3764 MTB NOT Xpert MTE Done j Microsoft Word 2010 Windows Movie Maker G EP 263 13 3761 NOT Xpert Done B Norton AntiVirus Delete 3 G EP 262 13 3760 MTB NOT Xpert MTE Done Genexpert Dx g 4 G EP 261 13 3759 MTB NOT Xpert MTE Done Adobe Application Manager A 7 Clear Contents x Microsoft Excel 2010 Adobe Captivate 6 32 Bit 10 Adobe Captivate Quiz Results Analyzer 6 0 11 Filter d i 8 Microsoft PowerPoint Adobe Captivate Re
16. User type Admin 3 Click on OK 8 Cepheid Proprietary amp Confidential gt Add User User Full Password Confirm Password GeneXper DX Software version 4 4 Create a Basic Account 9 O Cepheid Proprietary amp Confidential C Cepheid Create a Basic Account Define the persons in the lab that will have limited access to the software Can be more than one Basic account per system 1 Select setup gt User administration Select Setup Select Setup gt User administration administration Genexpert Dx Sy m IE User Data Management Rer TA User administr User Administration System Configuration She Create Test Checl Assign Instrument Letter T View Results _ ine S Define Graphs Maintenance Modules Tests Since Launch Module Sample Remaining Sample Mod Error Start EHE Assay ID Progress Status Test Time ID Name User Result Assay Status Status Date i User Administration User Name Full Philippe Philippe Admin Click on Add ER 10 Cepheid Proprietary amp Confidential Cepheid Create an Basic Account Basic Enter your Username and Password gt Add User User Name Full Name Password Confirm Password User Type Basic 7 pen Research admin 000 l 2 Choose the User type
17. aunch User Result Assay Status By closing the GeneXpert software vou will have the following screen Click on 5 Database Management Select task click Proceed to continue 2 Click on Database Restore 2 Database Backup atabase Restore 2 Compact Database 3 Check Database Integrity mmn Cancel Click on Proceed 3 Proceed 48 Cepheid Proprietary amp Confidential A warning message tells you that Database Restore current database will be lost Database Restore will OVERWRITE your current database with a backup database ick Proceed to continue with database restore cmm Click Procee to continue gt Select File To Restore The Database E Lookin DB xdaelaEel 3 706456 LAB CITY COUNTRY 2013 08 21 10 55 14 GX 1 4 17 zip Select the database to be restored and Click Open to continue File Name POR4T ORL AB CITY COUNTRY 2013 08 21 10 55 14 GX 1 4 1 7 zip Files of Type Database Backup lt zip open Cancel 49 O Cepheid Proprietary amp Confidential dialog box asks you if you want to create backup of the current database Click Proceed to create the backup Click Cancel to continue Backup Restore Database Restore Do you want to create a backup of the current database prior to restore 50 O Cepheid Proprietary
18. e Stop Test View Results Define Assays 4 Tests Since L winch Module assay Sampie progress Status Remaining Sample Mod user Res Assay staus mun Available Xpert M 05031 1 Kristians NO RESULT MTB RIF Ass Stopped OK 06 03 13 Available Available Available 20 Cepheid Proprietary amp Confidential GeneXper DX Software version 4 4 VIEW RESULTS 21 Cepheid Proprietary Confidential C Cepheid Click on VIEW RESULTS To visualize one particular result click on VIEW TEST gt GeneXpert amp Dx System DER User Data Management Reports Setup View Results About User lt None T DS 11 6 2 mm EN gt Create Test Check Status Stop Test Define Assays Define Graphs Maintenance Module Name 2 Views lt TestResutt Analyte Result Detail Errors History Support Result View Sample ID Assay Name Xpert MTB RIF Version 1 134723 Primary Curve Test Result R Assay Xpert MTB RIF For In Vitro Diagnostics Use Only Version 1 Reagent Lot ID 00303 Test Type Specimen v Sample Type Other _ v Other Sample Type Notes 300 Legend 1 n Probe D Primary v Probe C Primary Probe E Primary o 2 E lt Start Time 14 05 09 12 03 38 Mass Ee Eee 2 SPC Primary End Time 14 05 09 13 32 14
19. e Legend Probe C Prima Click on REPORT Notes Probe E Primary vi Probe B Primary vi SPC Primary vi Probe A Primary Start Time 20 12 11 11 59 46 End Time 20 12 11 13 48 17 Status Done v aad Status Urer laboratory technicia Fluorescence Cycles Save Changes Export ene i Upload Test Select Graphs View Test 29 Cepheid Proprietary amp Confidential How to generate a pdf report Select the result vou may want to visualize in pdf Test Report Patient ID blabal Test Report Sample ID XYZ Test Type Specimen Sample Type sputum Probe Check Details Melt Peaks Assay Information Assay Assay Version Assay Type vi Error Details Xpert MTE RIF 53 3 Vitro iagnoste Troubleshoot _ Messages Test Result MTE DETEC TED LOW Rif Resistance NOT DETECTED History Sample I mm Status Error Start Test and Analyte Result 2 Same RUN Analyte EndPt Analyte R2 22248 B4 KASHMEEL DETECT Xpert MTE RIF 03 1015 10 23 44 36 2 Name Result 182 21 529 Jacob MTB DETECT Xpert MTB RIF G3 10 1510 07 05 05 I R2 15952 A1 jacobj MTB DETECT MTB RIF G2 Done OK 10 14 10 02 45 59 m
20. est 3 Click OK 35 Cepheid Proprietary amp Confidential ZA GeneXper DX Software version 4 4 Data management tasks 36 Cepheid Proprietary amp Confidential C Cepheid Difference between Archive Backup The Archive contains only the raw results the technical Support will reguest you that file in case of complaint can only be retrieved with GeneXpert DX software Save the archive every week on a CD or RW CD extension 15 gxx The Backup contains all information about the system Log files errors raw results definition of assays can be used to restore the data on the GeneXpert DX software in case of computer failure backup all your data every month on a CD or RW CD extension Is zip 37 Cepheid Proprietary amp Confidential C Cepheid GeneXper DX Software version 4 4 How to archive results 38 Cepheid Proprietary amp Confidential C Cepheid gt Gene per BuSystem User Data Reports Setup View Results About O i I m rieve Te N aj Zo Create Test Check Status Stop Test View Results Define Assays Define Graphs How to archive results B Click Data Management Patient ID Assay Name MTE RIF G2 Version 2 Click Archive test m 1 Primary Curve F Test Resutt Views Test Resul
21. l Entry of the cartridge barcode 15 Cepheid Proprietary amp Confidential C Cepheid Manual Entry of the cartridge barcode If the barcode scanner is not working at that moment you can enter the cartridge barcode manually 1 cick B 2 A dialogue box will appear 3 Type manually the 2 line numbers of on Create Test Please scan cartridge barcode the cartridges see the picture Click on MANUAL ENTRY GeneXpert Dx System Scan Cartridge Barcode User a agement Trending Setup Please scan cartridge barcode Check Status CTT aea LOT 02803 2 2012 06 03 Modules Module Sample Manual Entry Cancel ID I 030333028031223 32774990 111 In case of barcode reader failure while using a new lot 4 this action cannot be completed Please contact Cepheid y technical support to collect the Lot Specific Parameter Enter the number without space 16 Cepheid Proprietary amp Confidential Create a test Once done the below screen will appear ai green light will blink from Fill In the Patient ID if Create Test ilabl a given module Open the door and place the cartridge Patient ID 5 Fill in the Sample ID Sample Name Select Assay Xpert MTB RIF G3 Select Modul At 02803 Expiration Date Sample Type other Other Sample Type
22. ll 3 x Select From MADONY To NDD YTY Control Trend Report Create Test System Log Assay Statistics Report lification Test Result T gt View Results Define Assays Sample ID Sputum Assay Name Xpert MTB RIF Assay G4 Test Result 1 3 iar 315611 emeaeepHe Generate Report File T temp Preview PDF will open the pdf file File Name Specimen Report 2013 05 03 14 04 02 pdf Files of Type GeneXpert Report Files pa v Generate Report File will save the report in GeneXpert Folder gt Report 32 Cepheid Proprietary amp Confidential ZA How to generate specimen and patient reports pdf Patient Report 2 Fill in the Patient ID Click Reports gt Patient Report GeneXpert Dx System Patient Report Date Range User Data Managemer Report S s lt Specimen Report Report 4 n J SN Select From MM DD r To Y pz AO nener 4 Patient Create Test Test View Results Define Assays Name Assay Statistics Report Patient ID Installation Qualification Test Result Patient 25 Patient ID Patient gt Assay Name Xpert MTB RIF Assay G4 Test Result itd ar o sy gt Generate Report File Generate Report Fie Priem Or Cose
23. mary End Time 14 05 09 13 32 14 2 am Probe Primary Status Done E 100 g User lt None gt Export Report N Cepheid 24 Cepheid Proprietary amp Confidential GeneXpert DX Software version 4 4 How to edit test related information 25 Cepheid Proprietary amp Confidential C Cepheid Edit test related info sample id If necessary you can edit the test related information and notes after the is finished of while i s running gt GeneXpert Dx System m EJ User Management Reports Setup View Results About User Kristians Jf Create Test Check Status Stop Test View Results Define Assays Define Graphs Maintenance All the white fields in this Module A4 Views E Test Result Patient Result View ti S primary Curve Assay MTE RIF Assay G4 Version 5 section are G EP 187 2 Test Result 125 Rif Resistance DETECTED editable Sample ID 1 3 7563 2 Far In Vitra Diagnostic Use Only Assay pert MTE RIF As say G4 Version 5 2 Reagent Lot ID 11012 2 Test Specimen 2 Views WEF Sample Other Result View vi 7 Probe D Primary Other S leT m Primary Curve Probe C Primary MEC c vi
24. rt MTB RIF G2 Done OK 09 09 10 09 34 52 39 Cepheid Proprietary amp Confidential Cepheid How to archive results Archive Test s In the nest dialog box click Proceed Save The files will be saved in the folder Export In the file name you will see the date of archiving heic ala x BE GeneXpert PC 2011 08 05 09 29 46 XXx 5 GeneXpert 2011 08 05 10 42 28 9Xx It is highly advised to save write your archived data on a RW CD File Mame Genexpert PC 2011 08 05 11 22 40 8 Files of Type GeneXpert Archive Files gxx T Click on SAVE Save Cancel Archive Test s 12test s successfully archived 4 Check details in C GeneXpert Dat ogArchive log 2011 08 06 11 22 54 txt Click 40 Cepheid Proprietary amp Confidential GeneXper DX Software version 4 4 How to retrieve results 41 Cepheid Proprietary amp Confidential C Cepheid How to retrieve results gt GeneXpert amp Dx System User sata Managem Reports Setup View Results About Archive Test Retrieve Test Click Data Management gt A Wr 1 d by Create Test Check Status View Results Define Assays Define Graphs Click Retrieve Test Module Name 1 Patient ID Assay Name MTE RIF G2 Version 2
25. t 715 if Resistance NOT DETECTED Sample ID Select Test s To Be Archived a Deselect All Select Highlighted Deselect Select New Delete Archived Highlighted Archie Tests Patient ID ponen Choose the tests that test R2 21936 A1 KASHMEEL MTB DET Xpert Done 10 16 10 02 36 58 need to be archived O R2 20646 B _ KASHMEEL NOT DET 10 16 10 02 35 14 a R2 22237 C2 KASHMEEL Xpert MTB RIF G3 10 15 10 23 45 23 O R2 22248 B4 KASHMEE __ MTE RIF G3 Done 10 15 10 23 44 36 Or Select All O R2 21529 Xpert MTE RIF G3 Done 10 15 10 07 05 05 O R2 15952 jacobj MTB DETECTE Xpert MTE RIF G2 Done OK 10 14 10 02 45 59 O R2 2086 C3 INVALID Xpert MTE RIF G2 Done 10 14 10 02 38 01 O ATCC 25177 1 DETECTE Xpert MTB RIF G2 Done 103 10 23 50 21 O R2 13883 B1 jacobj DETECTE Xpert MTB RIF G2 Done 10 13 10 02 34 30 You can choose to Delete R2 18792 C4 DETECTE Xpert MTB RIF G2 Done 10 12 10 02 59 46 O R218715 jacobj DETECTE Xpert MTE RIF G2 Done 10 07 10 02 43 30 Arc ived Te sts J R1 72066 ALISHA MTB DETECTE Xpe
26. ut Tests Since Launch 2 TestTime ED 4 Cepheid Proprietary 8 Confidential Cepheid Prepare your system for the routine use In case the software was closed computer still opened to reopen it double click on the GeneXpert DX on the desktop and follow steps 4 and 5 page 3 E rei 5 Cepheid Proprietary 8 Confidential GeneXper DX Software version 4 4 Create an Administrator Account Admin N 5 4 1L ua Create an Administrator Account Admin 1 Select setup gt User administration Select Setup Select Setup gt User administration administration z JEJ GeneXpert Dx Sy m User Data Management Rer User administr User Administration D E p IEKE G System Configuration Create Test Assign Instrument Letter 8 View Results Define Assays Define Graphs Maintenance Modules Tests Since Launch Module Sample Remaining Sample Mod Error Start Assay ID Progress Status Test Time ID Name User Result Assay Status Status Date Hame User Administration User Full Name Philippe Philippe Admin mm NM M Remove Qese Close Cepheid 7 Cepheid Proprietary amp Confidential Create an Administrator Access Admin Enter vour Username and Password 2 Choose the
27. v Probe A Primary Status Done E 100 User lt gt Export Report N 22 Cepheid Proprietary amp Confidential Cepheid View results Select Test To Viewed Rim iei i um Double click on the test you want to see 23 Cepheid Proprietary amp Confidential vietnam 2 JOSE ALMEIDA South Sudan 1 Mam 724 751 v 741 Rif mutant Test 2 For mutant Tast 1 Fit WT Test 2 il WT Test 1 m al Al AJ A2 A1 AJ Al Spurum matre te M Rif mutant Test 3 WT 4 MRM WT Test 3 M Rif WT Test M Rif WT Test 5 A2 Al M Rir mutant Tast 1 M Rif mutant Tasi 2A1 M Rif WT Test 2 M Rif WT Test 1 1 NOT DET MTB NOT DET NOT DET MTE NOT DET DETECT MTB DETECT WTE NOT DET MTB DETECT MTB DETECT MTB DETECT DETECT DETECT NOT DET DETECT MTB DETECT MTB _ MTB DETECT MTB MTB DETECT DETECT MTB DETECT Xpan MTE RIF 03 MTE RIF 03 pen MTB RiF 53 port MTE RIF 03 MTE FriF 133 MTE RIF 03 pert MTE RIF 02 Xpan MTEL RIF 03 MTB FriF G3 per Assay Xpan NTE RIF Assay a par MTD FiF MTE RIF Xpan MTE RIF MTB FriF
28. viewer 6 12 art 19 12 SOIT 2 Adobe Help 13 20 Jotenat o rmmamt 21 a Notepad Adobe Media Encoder 56 ito cp sdobe Centivate 0677 14 Adobe Captivate 6 m e F Le 3 Mozilla Firefox 15 3T Cepheid 16 Pick From Drop down List All Programs Microsoft SQL Server 2005 17 Define Mame 7 ldem Log Off 9 Turn Off Computer 18 Hyperlink a 18 Genexpert Dx System ti Document Microsof 20 N 57 Cepheid Proprietary amp Confidential Cepheid For information on GeneXpert DX Software GeneXpert User Manual GeneXpert Dx System Operator Manual Software Version 4 C 301 0045 Rev B March 2012 FTP server ftp hbdc Crasa7UcQftp caplaser net Copy and paste the link in Windows Explorer not Internet Explorer 59 Cepheid Proprietary amp Confidential E rei
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