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Viper™ LT System

1. Figure 6 13 Save Data to USB Window To Save Data to USB 1 Access the Save Data function as described above 2 Insert a USB flash drive into a free USB port 3 Select what data you want to export and specify any optional parameters see Save Data to USB Fields and Buttons below Tap the save data to USB button Tap the Yes button to confirm that you want to export the data If you do not want to export the data tap the No button 6 A progress bar at the bottom of the window shows progress of the export function While the export is in progress the abort export button appears at the right of the window in place of the exit button To abort the export process tap the abort button Tap Yes in the confirmation window to abort the export or tap the No button to continue the data export 8 When the exit button returns to the display you can remove the USB flash drive and exit the window 6 22 500005363 02 6 Maintenance Save Data to USB Fields and Buttons Save Data Window System Log checkbox This item is selected by default Exports the system event log Database checkbox This item is selected by default Exports the Rack database Configuration checkbox This item is selected by default Exports the instrument configuration Log Files Window SPC Window SPC files are log files created during a system event log purge Temperature checkbox
2. 2 8 Figure 2 3 System 2 11 Figure 2 4 LIS Setup 2 14 Figure 3 1 BD Viper LT Instrument 3 2 Figure 3 2 Main Power Switch left side of 3 3 Figure 3 3 Specimen Rack Top View 3 5 Figure 3 4 Specimen Rack Side View open 3 6 Figure 3 5 Extraction Rack cover 3 7 Figure 3 6 Extraction Rack removing 3 8 Figure 3 7 Lighted Login Station assembled 3 9 Figure 3 8 Lighted Login Rack Base USB port shown at left 3 10 Figure 3 9 Lighted Login Rack Tube Alignment 3 10 Figure 3 10 USB Ports 1 3 12 Figure 3 11 Thermal Tool Overall 1 3 14 Figure 3 12 Thermal Tool Top 3 14 Figure 3 13 Onscreen 1 3 15 Figure 3 14 Numeric 3 15 Figure 4 1 Rack Logi
3. Assay Configuration instruments distributed in the U S Assay Version Available GCQx 230344 M CTQx 230341 x CTQx GCQx 2 30 34 1 Figure 2 2 Instrument Tab v buttons To move an assay up or down in the list tap its name row Then tap the or Y button to move the assay in that direction The order of the Available assay list shown in this window is the order that assays appear in the Test Type field of the Rack Login dis play The first item in the list is the default Test Type on the Rack Login display 500005363 02 2 Installation assay configuration button Tap to access assay specific configuration options Refer to the appropriate user s manual addendum for additional information 2 4 2 System Tab The System tab enables you to set several system wide parameters such as maintenance schedule and sound level and to view version information See Figure 2 3 To access the System Tab From the Main display tap the configuration maintenance button System Tap the System tab System Tab Fields Maintenance Schedule This field enables you to select a time for automatic Daily Maintenance If Daily Maintenance has not been performed manually by the specified time the instrument performs it automati cally at the start of the next run after the scheduled time Hour To adjust the hour value tap the Hour field and then tap the desired hour in the drop down b
4. Otherwise recap immediately Store recapped tubes or discard in disposal bag O Change gloves O Seal the priming plate with a black plate seal and remove the plate from the stage Remove the sealed priming microwells from the plate by holding the sides of the seal and lifting the wells straight up as a unit Remove sealed amplification microwells and amp plate adapter Place the microwells into a disposal bag and seal Place the bag in a solid waste container biohazard O Remove extraction tubes and place in a resealable bag Dispose of in a biohazard waste container CJ Change gloves O Remove and discard fully used pipette tip boxes in regular trash Partially used boxes can remain on the instrument Turn the trough lockdowns to the sides to remove the reagent trough Seal the trough in a resealable disposal bag and discard in regular trash Keep spent troughs upright while handling O Change gloves if wet O Remove the extraction tube tray and cover and microwell plates and adapter Using care place the items into a wash basin and submerge them in 196 v v sodium hypochlorite solution for 2 3 minutes Rinse these items thoroughly with tap water and allow them to air dry Shake excess water out of the amplification tray before allowing to air dry O Check the waste tip bin on the right side of the deck If the bin is ess than half full continue to the next bullet If the bin is half full or more use the
5. ed Ee 4 31 4 9 5 3 Reagents Trough and or Extraction Tubes Cleanup 4 31 4 9 5 4 Cleaning Priming 4 32 500005363 02 Preface Contents 4 9 5 5 Cleaning Amplification Stage 4 33 4 10 Power llc M 4 33 5 Reference 511 General vesicle ET 5 1 5 2 Rm 5 2 5 3 Main Status ertet teens red cra ih rid red a E TAN x ER gd 5 3 5 4 Rack Operations Menu 5 7 5 4 1 Rack Login Display niet tete t dtes etae theta ED epe ex 5 9 5 4 1 1 Plate Layout DisplaYy ii 5 17 5 4 1 2 Extraction Lot Logie erene cente khe die dena 5 22 5 442 Modify Hack Display acilia ie tee qa eng d 5 25 54 3 Copy Rack Display iicet et ii elle 5 27 5 44 Delete Rack Bisplay reet iU eee Hd auda 5 29 5 5 Start R n UE EVE 5 31 56 R n Stat s Display Im em rr o e PEE EE YR P cede ER ERA EAR RIP M ies 5 36 Reports srl eee fate Nee ek 5 38 5 7 1 Tube Layout eco er eaae aie UR eo ERR Pn RP ae ERRORES 5 40 5 7 2 Tube Result Report eden dct te etr tae 5 42 5 7 3 Temperature History Report 5 46 5 7 4 Search by Accession Number 4 5 49 5 7 5 Export Tube Demographics
6. 1 9 Summary of Cautions and Warnings 1 10 2 Installation 2 1 2 2 2 3 2 4 2 5 elc es 2 1 Instrument Specifications reete Dep Duet 2 2 Instrument InstallatlOri ent det Re nte fee uneven tu Eae ed 2 4 2 3 1 Site Preparat ria neea a ela a 2 4 DEINER 2 4 2 4 1 Instrument Fabi aaa ii 2 6 2 4 2 System Tabiano 2 9 24 93 lools TDI ET 2 11 244 SEIS Setup Tabiano 2 12 2 15 3 Controls and Indicators 3 1 3 2 3 3 3 4 e Jpldgm 3 1 Main Power senes 3 3 Be 3 4 Specimen ella 3 5 500005363 02 iii BD Viper LT System User s Manual 3 5 3 6 3 7 3 8 3 9 3 10 3 11 3 12 Contents Extraction E 3 7 BD Pre warm Heater eee dores eR ai 3 8 Lighted Login Station 3 0 Monitor and ceat eai eot ee te brun haee E 3 11 USB POMS c ae 3 12 Temperature QC Thermal 2 3 13 Onscreen Keyboard iaia e 3 15 Audible Tones and Alarms tort t eee one ii 3 16 4 Operation 4 1
7. 4 4 3 Setting up Plates 4 4 3 1 Assays Required Materials Priming plate e Priming microwells e Amplification plate and plate adapter e Amplification microwells gray Blank microwells Procedure 1 Tap the plate layout button to view the Plate Layout display s see Figure 4 4 If needed you can enter new microwell lot numbers in the Plate Layout display You can also view how to lay out microwells on the priming and amplification plates 2 assign or change an assay microwell lot number tap the location on the Plate Layout display where you wish that lot number to begin Type in or scan the lot number or barcode Tap the save button to save the lot number When you log in multiple assays per rack if you change the lot number it changes the lot number for the current microwell and all subsequent ones Note that microwell locations where a lot number change would result in an invalid plate con figuration e g if the change would result in insufficient QC coverage do not bring up a dialog box enabling you to change the lot number when they are tapped If there is no default microwell lot defined then all the microwells except the first one behave in this manner 3 Load priming microwells into priming plate s as shown on the display Priming microwells are color coded as follows CT Qx Solid Green and Purple GC Qx Solid Yellow and Purple 4 Load gray Viper LT Amplification microwells into amplification pla
8. Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument is unable to detect that the plate seal tools have been released CORRECTIVE ACTION S Effect Robot End of Run activities are not performed The reader portion of the run in progress continues if detected during the consumables check Future runs are prohibited NOTE You must repeat the run if any portion was aborted Error may be corrected by running Robot QC Configuration Maintenance Tools QC Functions Robot QC Run Consumables Management Disposal Protocols to dispose of hazardous extraction materials Configuration Maintenance Tools Manage Consumables Empty Reagent Troughs Empty Extraction Tubes If this does not correct the problem cycle instrument power If error persists contact your local BD representative EC 8010 Plate seal general failure ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S An unknown or unexpected robot error plate seal related has occurred CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted 500005363 02 7 19 BD Viper Instrument User s Manual Robot End of Run activities are not performed The reader portion of the run in pr
9. 13 3 BD Viper LT System User s Manual 13 4 500005363 02 Viper LT System User s Manual enue N sasn ulo3s S 1 1ediA PRINTING SPECIFICATION DO NOT PRINT THIS PAGE First page is printed with supplied artwork on Vellum bristol 67 Ib white 8 1 2 X 11 3 hole drilled Interior pages excluding first and last pages and Reader Comment Card are printed with supplied artwork on Paper 60 Ib white offset 8 1 2 X 11 3 hole drilled e Print 2 sided with odd pages on right even pages on left e Spot color headings table headers is BD Blue PMS2755U best match if digital copied Last page is blank Vellum bristol 67 Ib white 8 1 2 X 11 3 hole drilled Binder Inserts Binder cover insert is printed with supplied artwork on Cover stock 100 Ib glossy white 10 X 11 Spine label insert is printed with supplied artwork on Cover stock 100 Ib glossy white 1 3 4 X 11 Text color is BD Blue PMS2755 best match if digital copied All other ink is Black Tab Set Paper for tab set is e Paper 110 Ib index white 8 1 2 X 11 clear mylar reinforced 3 hole drilled Fontis Arial 12 pt e Ink color is BD Blue PMS2755U e Tabs to be cut in 2 banks of 4 tabs e Bank 1 imprints proper title case as shown Introduction Installation Controls and Indicators Operation e Bank 2 imprints proper title case as shown Reference Maintenance Troubleshooting Appendices Man
10. Effect The assay cannot be selected during login until the condition is corrected Reports contain ing that assay cannot be generated Contact your local BD representative EC 6001 LIS not responding ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S Communication to the LIS has been interrupted The message is displayed only once when LIS communication is lost If message recurs it indicates that communications were restored then lost again CORRECTIVE ACTION S Effect Runs in progress are not affected Verify physical communication link to the LIS cables at both ends of link Verify status of LIS powered on and ready for communication from instrument EC 7005 Liquid movement error ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window 500005363 02 1 15 BD Viper Instrument User s Manual POSSIBLE CAUSE S During an aspirate dispense or mix operation an unexpected liquid handling error occurred CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted A Disposal Protocol or Volume QC oper ation in progress is also aborted The reader portion of the run in progress continues Future runs are permitted NOTE You must repeat the run if any portion was aborted Message is informati
11. Manufacturer Id CONTROLZRUS Rehydrate External control Lot Number 12345678901234567890 aC gt Positive Negative Delete Cancel Figure 5 6 Tube Login Window for External Control Report Results pane checkboxes The Report Results pane is located at the bottom of the Tube Login window It appears when you select an assay that contains more than one test type e g CTQ GCQ By default both test type results are checked and are reported on the Tube Result Report and to the LIS if enabled To report only one type of result clear the checkbox next to the test type result you want to suppress That test type s result is then suppressed on the Tube Result Report LIS upload The assigned specimen location reflects whether results are suppressed by taking on the well color of the reported result see Rack Login Display Icons and Buttons Single test types cannot have results suppressed 5 16 500005363 02 5 Reference Save button Tap to save the specimen Delete button Tap to delete the specimen Cancel button Tap to cancel the current operation 5 4 1 1 Plate Layout Display The Plate Layout display enables you to view the layout of the plate s for the specimen rack that has been logged in and to enter the assay lot number for microwells The display is accessible from the Rack Login display after a specimen rack has been
12. Tools QC Functions Prime Heater QC If problem persists contact your local BD representative EC 3001 Communication failure to Priming heater temperature controller ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument cannot communicate with the temperature controller CORRECTIVE ACTION S Effect The robot portion of the run in progress is aborted 500005363 02 7 9 BD Viper Instrument User s Manual Future runs are prohibited NOTE You must repeat the run if any portion was aborted To correct the problem cycle instrument power If problem persists contact your local BD representative EC 3002 Priming heater temperature controller diagnostics failed ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The Temperature Controller failed its internal diagnostic checks during initialization CORRECTIVE ACTION S Effect Future runs are prohibited To correct the problem cycle instrument power If problem persists contact your local BD representative EC 4001 Reader communication failure ALERT TYPE Persistent Cleared when a the instrument considers the error
13. 14400 19200 28800 38400 57600 or 115200 Data Bits Tap the field to drop down a list of supported data bits used in serial communications with the LIS then tap the desired number to select it You can select 7 or 8 default Parity Tap the field to drop down a list of parity checks used in serial communications with the LIS then tap the type to select it You can select NONE default ODD or EVEN Stop Bits Tap the field to drop down a list of supported stop bits used in serial communications with the LIS then tap the desired number to select it You can select 1 default or 2 Number of Days between Specimens Enter the number of days to allow before either updating a given accession or adding a new accession in the database Time is based on rack definition time You can enter from 0 to 999 days default 2 days Upload Algorithm Results Checkbox Tap the checkbox so that a check appears in it to enable the Upload of Algorithm Results When enabled the numeric value of the result is sent to the LIS these values are shown on the Tube Result Report To disable upload of numeric results tap the checkbox so that the check disappears default 500005363 02 BD Viper LT System User s Manual Figure 2 4 LIS Setup Tab 2 14 500005363 02 2 Installation 2 5 Instrument Startup Whenever power is applied to the instrument the following operations are performed log and data da
14. 2 44 EA 5 52 5 8 Configuration Maintenance eene ener enne 5 54 5 8 1 ion 5 54 5 9 Instrument Alerts Display 5 57 6 Maintenance 6 1 6 2 eld m 6 1 Routine Maintenance 6 2 6 2 1 Daily Maintenarice eder ttr re tetris eeu 6 3 6 2 1 1 Check Printer Paper 6 0 0 0 nnne nennen 6 3 6 2 1 2 Daily Maintenant 6 3 6 2 1 3 Check Pre warm Heater 6 5 6 2 1 4 Check Lighted Login 6 7 6 2 2 Weekly Maintenance viaccess tenente utn entities 6 9 6 2 3 Monthly Maintenance nnne nennen ener nnne nne nnns 6 16 6 2 3 1 Monitoring for the Presence of DNA Contamination 6 16 6 2 3 2 Replacing the Plate Seal Tool Suction 6 17 500005363 02 V BD Viper LT System User s Manual Contents 6 2 8 8 Replace Air Filter iii 6 18 6 2 4 As Needed Maintenance 6 20 6 2 4 1 Save Data to USB Window nens 6 21 6 2 4 2 Install SoftWare 6 25 6 2 4 3 Manage Consumables i 6 27 6 2 4 4 Register Barcode Scanner Function 6 31 6 2 4 5 Move Robot Reader Function esee 6 3
15. 6 22 Figure 6 14 Manage Consumables 6 29 Figure 6 15 Register Barcode Scanner 6 31 Figure 6 16 Move Robot Gantry Reader 6 33 Figure 6 17 Calibrate Touchscreen 6 36 Figure 6 18 Calibrate Touchscreen Confirmation 6 37 Figure 6 19 Pre warm Heater QC Temperature lt 6 40 viii 500005363 02 1 Introduction 1 1 Intended Use The BD Viper LT System is intended for in vitro diagnostic IVD use in clinical laboratories to perform automated extraction of nucleic acids from multiple specimen types amplification of target nucleic acid sequences by Strand Displacement Amplification SDA and detection of amplified nucleic acid using a two color fluorescence detection system The BD Viper LT is for use only with in vitro diagnostic tests labeled for use on the system 1 2 Overview The BD Viper LT system uses homogeneous Strand Displacement Amplification SDA as the amplifi cation method and fluorescent energy transfer ET as the detection method to test for the presence of pathogens by their genetic content in clinical specimens Specimens are logged in and undergo a pre warm step in the BD Pre warm heater The pre warm step serves to dissolve mucus
16. BD Viper LT System User s Manual Becton Dickinson and Company 7 Loveton Circle Sparks MD 21152 USA 500005363 02 2015 01 Catalog Number 442839 English US Version BD Viper LT System User s Manual Change History Revision Reason U S only version no PCR capability Add Pre Warm Controller to section 2 4 2 replace Pre warm Heater figure 4 5 Add run sta tus button on page 4 21 update weekly mainte nance instructions replace Volume QC Log fix miscellaneous typos Updated branding Changed Appendix Letters to Numbers Added catalog number to cover Added updated procedure for reconnecting Viper LT Sensor Waste Cable Updated bottle drying direction Corrected Lighted Login Station cata 4 28 4 29 10 2 log number This product is sold under license and purchase of this product does not include rights to use for cer tain blood and tissue screening applications nor for certain industrial applications Alconox is a trademark of Alconox Inc DNA AWAY is a trademark of Molecular BioProducts Eliminase is a trademark of Decon Laboratories PreservCyt is a trademark of Hologic Inc BD BD logo and all other trademarks are property of Becton Dickinson and Company Copyright Becton Dickinson and Company 2015 All rights reserved No part of this publication may be reproduced transmitted transcribed stored in retrieval systems or translated into any
17. Highlight Search by Accession Number Type in the desired accession number or scan the Enter or Scan Accession Number accession barcode Search Tap the Search button The Search by Accession Number Report provides the following information Accession Rack Information Accession Rack e Rack Barcode e Date Time that the specimen was tested For QC Tubes e Tube QC or QC Kit Expiration e Results 500005363 02 5 49 BD Viper LT System User s Manual Sample e Tube e Results Positive Negative Error Extraction Control Failure Liquid Level Failure Extraction Transfer Failure Xa E 5 50 500005363 02 5 Reference lt Tube Result Report ui E Export Tube Demographics Ert Accession Search Enter or Scan Accession Number mm Accession Rack Rack Barcode Date Time 8 91013 9 10 2013 12 42 00 PM 8 91013 9 10 2013 12 42 00 PM 8 91013 9 10 2013 12 42 00 PM 8 91013 9 10 2013 12 42 00 PM o m QC Tube Kit Expiration CTQx GCQx QC 1111111 11 11 2011 OK 2015 OK 1804 QC 1111111 11 11 2011 OK 45 OK 67 Sample CTQx GCQx Col 59 Oe 2029 Figure 5 22 Search by Accession Number Report 500005363 02 5 51 BD Viper LT System User s Manual 5 7 5 Export Tube Demographics Export Tube Demograph
18. Highlight Temperature History In the Report Parameters window enter the Start Date mm dd yyyy by typing in the date or by tapping the calendar button to the right of the field and tapping the desired date the field a defaults to blank e or Enter the End Date mm dd yyyy by typing in the date or by tap ping the calendar button to the right of the field and tapping the desired date the field defaults to the current date Tap the print button The Temperature History Report provides the following information for all runs within the specified date range Report Header Instrument name BD logo Title Temperature History Report Date and time that report was printed Instrument number and ld Current system software version Page number Date Range parameters 5 46 500005363 02 5 Reference Main Body of Report Run Started the date and time that the run started Rack rack number and rack barcode Plate the plate number Priming column shows the Priming plate temperature at the end of the Heat Spike Warming column shows the Amplification plate temperature at the end of the Heat Spike Reader shows the average temperature while the plate is being read Report Legend A bold line indicates that the run on that line was aborted A next to a temperature indicates that it was below the minimum temperature for that stage A 1 next to a tempera
19. If error persists contact your local BD representative EC 14002 Fixed barcode scanners not configured ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument has detected an onboard barcode scanner that has not been configured The spe cific barcode scanner is identified in the message text CORRECTIVE ACTION S Contact your local BD representative 7 32 500005363 02 7 Troubleshooting EC 17001 Low disk space on drive C ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S Free space on the C drive is less than 596 of available disk space CORRECTIVE ACTION S No effect on any portion of a run in progress Cycle instrument power If error recurs contact your local BD representative EC 17002 Low disk space on drive D ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S Free space on the D drive is less than 596 of available disk space CORRECTIVE ACTION S No effect on any portion of a run in progress If error recurs contact your local BD representative EC 19001 Lighted Login station failed initialization A
20. allows you to monitor step by step status information on the run and to abort any run in progress e Reports Menu allows you to print instrument reports search for results by accession number and export run demographic data Configuration Maintenance Displays allow you to perform instrument setup configuration and maintenance functions e Instrument Alerts Display shows any alerts that prevent the instrument from starting run and that occur during a run 500005363 02 1 5 BD Viper LT System User s Manual BD Viper LT V2 30A US MS a 7 30 2013 Tuesday 4 26 PM Pre warm Heater w BD Figure 1 3 Main Status Screen 1 6 500005363 02 1 Introduction 1 4 Manual Structure This user s manual contains the following sections Section 1 Introduction provides an overview of the BD Viper LT instrument and its uses in the laboratory its major hardware and software components An overview of this manual s structure and conventions is also included Section 2 Installation gives specifications for the BD Viper LT instrument and instructions for instrument setup Section Controls and Indicators explains the use and meaning of all controls and indicators of the instrument Section 4 Operation provides instructions for routine instrument operation e Section 5 Reference provides reference material on the user interface Secti
21. configuration maintenance button Instrument Tab Icons and Buttons configuration maintenance indicator assay f door unlocked indicator configuration button exit button DES instrument number indicator door locked indicator da Instrument Tab Fields Instrument Window Instrument Number Select the instrument identification number by tapping the field and tapping the desired number in the drop down box The default setting is 1 To see numbers above or below the ones displayed drag the scrollbar in the drop down box up or down You can choose a number from 1 to 99 If there is only one instrument at your location you should leave this value set at 1 Walkaway Checkbox Select whether Walkaway mode is enabled checked or disabled unchecked by default on the Start Run display The default setting is disabled unchecked Walkaway mode enables the instrument to perform a complete run in its entirety The instrument does not pause to allow you to enter the next run s amplification plate In High Throughput mode the amplification plate for the run can be placed on the Warming heat ers just before the plate is pipetted into and tested in the reader at the Heat and Transfer message When Walkaway mode is enabled you can still uncheck disable the box in the Start Run display when you initiate the run for a given run to execute that run in High Throughput mode 500005363 02 2 Insta
22. 7 Troubleshooting EC 13003 Puncture tool not picked up ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument cannot pick up the puncture tool CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted The reader portion of the run in progress continues Robot End of Run activities are not performed NOTE You must repeat the run if any portion was aborted Make sure the puncture tool is in its station in the reagent trough If error recurs frequently contact your local BD representative EC 13004 Puncture tool not released ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument is unable to detect that the puncture tool has been released CORRECTIVE ACTION S Effect During instrument initialization a system alert is generated and the instrument initialization stops The robot portion of a run in progress is aborted The reader portion of the run in progress continues Disposal Protocol is aborted if in progress Future runs are prohibited Robot End of Run activities are not performed NOTE You must repeat the run if any portion was aborted Error may be corrected by running Robot QC Configuration Ma
23. Empty Reagent Troughs or Empty Extraction Tubes or both menu selection s The Consolidate Pipette Tips menu selection becomes automatically selected 3 A message appears instructing you to place full pipette tip boxes in empty pipette stations When you have completed this action tap the Yes button to continue with the disposal or tap the No button to return to the Manage Consumables menu 4 To abort the disposal function while it is in progress tap the abort button In the confirmation window tap the Yes button to abort the function or tap the No button to proceed with the disposal function Any reagents remaining in the troughs or extraction tubes remain potentially caustic and or infectious You should re run the appropriate disposal protocol s before attempting to remove reagents manually Should it be necessary to manually remove reagents extreme caution must be exercised in handling them Observe all handling safety recommendations described in WARNING boxes in Section 4 Operation 5 The instrument makes a defined number of attempts to empty the reagents from the specified locations If it is able to successfully empty the reagents results of pass are reported at the right of the menu selection If the disposal protocol is unable to successfully remove the reagents or if the disposal is aborted results of fail aborted are reported at the right of the menu selection for the selected p
24. Tools QC Functions Maintenance Daily If error persists contact your local BD representative EC 10015 Robot firmware update error ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument reported an error when the robot firmware was updated CORRECTIVE ACTION S Effect Runs are prohibited To correct the problem cycle instrument power If problem persists contact your local BD representative EC 12001 Extractor Magnets failed to reach the home position ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument was unable to detect that the extraction magnets returned to their home position CORRECTIVE ACTION S Effect During instrument initialization a system alert is generated and the instrument initialization continues The robot portion of a run in progress is aborted However run does not have aborted status since specimen processing did not begin due to the error The reader portion of the run in progress continues Future runs are prohibited Error may be corrected by running Magnet QC Configuration Maintenance Tools QC Func tions Magnet QC If this does
25. Yes button to proceed or tap the No button to cancel the function If you select No you are returned to the QC menu 4 To abort the QC function while it is in progress tap the abort button In the confirmation win dow tap the Yes button to abort the function or tap the No button to proceed with the QC function 5 When the function is complete the status is displayed at the right of the menu selection H pass indicator fail aborted indicator 6 Ifa pass result is reported the alert condition is cleared If fail is reported contact your local BD representative for assistance 6 38 500005363 02 6 Maintenance 6 2 4 8 Pre warm Heater QC instrument thermal verification Pre warm Heater QC verifies heater operation by performing a heating and cooling protocol The 6 onboard heaters and temperature sensors 2 per heater for each heater are all verified One tempera ture sensor controls the heater primary and one is a QC sensor The temperatures between each sensor primary and QC for each heater are checked at the end of the heating and cooling cycle If the temperature difference between the two are not within an acceptable range the QC fails If the QC passes alerts for the Pre warm heater are cleared Pre warm Heater QC takes up to 60 minutes to complete Make sure there is no specimen rack on the Pre warm heater before initiating Pre warm Heater QC To run Pre warm Heat
26. leeoooo pai 0660000 0660000 oooo oooo 00000 0600000 Figure 5 10 Extraction Lot Login Display Extraction Lot Login Fields Extraction Rack Layout The placement of extraction tubes is shown in a layout display Each circle represents an extraction tube location in the extraction rack Dark gray circles represent assigned locations and lighter gray circles represent unassigned locations An asterisk overlaying an assigned tube location indicates a new not yet saved lot number 500005363 02 5 23 BD Viper LT System User s Manual To enter modify an extraction tube trough lot number tap the position where the lot begins The Modify Extraction Tube Lot window appears See Figure 5 11 Lot Number field Scan or type in the lot number of the kit The lot number is a 7 digit numeric value Expiration Date field If you scan the lot number of the kit the expiration date is entered automatically If you typed in the lot number enter the Expiration Date in this field in the form yyyy mm dd where yyyy is the year mm is the numeric month and dd is the day Save button Tap to save the information The lot number is used by the system for all tubes subse quently logged in and for all tubes past the selected position until a new lot number is entered maximum of two Newly entered lot numbers are indicated by an asterisk overlaying the tube icon Cancel button Tap to can
27. or whose tests were aborted The report is sorted by rack location Symbols representing each type of result are printed for each tube and symbols for QC results that represent Pass Fail Liquid Level Failure or EC failure are printed for each control A sample Tube Result Report is shown in Figure 5 20 The Tube Result Report prints automatically at the end of a run or by request up to the latest 30 racks The Tube Result Report provides the following information Report Header Instrument name BD logo Title Tube Result Report Date and time that test completed Instrument number and ld Current system software version Page number Rack number assigned by instrument and barcode La continuation icon if report is multi page Assay and version number Extraction Tube Lot numbers and locations Reagent Trough Lot number Main Body of Report Kit number if more than one is used they are designated as 1 and 2 Tube location sort order of results 6 rehydration icon positive negative Accession and lot number 1 or 2 indication if applicable cont below 5 42 500005363 02 5 Reference Positive negative control results with kit number OK Pass Fail if either control fails no results for that assay in that kit are reported Liquid level failure Test result columns for each assay type results indicated by one of the following symbols Positive a numeric
28. 2013 GO Test Group Type SDA Figure 5 23 Tube Export Parameters Window 500005363 02 5 53 BD Viper LT System User s Manual 5 8 Configuration Maintenance The Configuration Maintenance display features 4 tabs Instrument System Tools and LIS Setup When you tap the configuration maintenance button the Instrument tab appears Configuration Maintenance functions can be accessed after instrument initialization is complete 5 8 1 Instrument allows you to set the instrument number Walkaway mode enable disable and available and default assays This tab is discussed in detail in Section 2 4 1 System allows you to set instrument time and date maintenance schedule and audible alarm volume also displays read only version information This tab is discussed in detail in Section 2 4 2 Tools allows you to save data to USB media to update the instrument software and to perform several maintenance and QC functions manage consumables register a barcode scanner and move the robot These functions are discussed in greater detail in Sections 5 8 1 LIS Setup allows you to set parameters for communication with a LIS system This tab is discussed in detail in Section 2 4 4 Tools Tab The Tools tab enables you to perform the following maintenance and QC functions Save Data to USB Section 6 2 4 1 Install software Section 6 2 4 2 Perform QC maintenance functions Section 6 2 Mana
29. Check to export the templog file This file contains informa tion on heater temperatures during QC Liquid Level Error checkbox Check to export the liquiderrorlog file This file contains information on liquid level errors that occur during QC System Alerts checkbox Check to export the alertlog file This file contains informa tion on system alerts that have occurred Run Count checkbox Check to export the runcountlog file This file contains informa tion on the status of the plate when rack testing has completed QC checkbox Check to export the QClog file This file contains information on the status of QC tubes on a rack when the run completes Magnets checkbox Check to export the magnetlog file This file contains information on the steps required to move to the top position when the move command was sent during consumable check or QC EC checkbox Check to export the eclog file This file contains information on Extrac tion Control results for each well on the plate when the run completes Diagnostics checkbox Check to export diagnosticslog file This file contains information related to instrument self diagnostic functions Viper Log checkbox Check to export the viperlog file This file contains filtered items in the system log file Remote Diagnostics checkbox Check to export the remotediagnosticslog file This file contains information on remote diagnostic functions Year Dropdown Tap
30. Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument was unable to pick up plate seal during a run plate seal step CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted Future runs are permitted NOTE You must repeat the run if any portion was aborted In most cases this message is caused by one of three conditions 1 the plate seal was not replaced by the instrument in the plate seal station during consumable check 2 the plate seal tool was not in its station when the instrument went to acquire it or 3 the plate seal tool suction cups malfunctioned Make sure the plate seal and plate seal tools are in place before starting a run Try cleaning the suction cups with an alcohol wipe If message recurs replace plate seal tool suc tion cups Make sure the 2 pieces of each metal stem are screwed together EC 8003 Dropped plate seal during run ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument has detected that a plate seal was dropped Effect The robot portion of a run in progress is aborted Robot End of Run activities are not performed Future runs are permitted CORRECTIVE ACTION S Locate and remove plate seal if it was dropped Do not reuse it Make sure the plate seal and plate seal
31. Configuration Maintenance Tools Move Robot function to move the robot gantry to access the waste bin Remove the waste tip bin from the deck remove and seal the disposable liner Dispose of the sealed waste bin liner with biohazard waste in a double bagged biohazard container Place a new waste bin liner containing an absorbent pad in the waste tip bin Align the stripe on the liner at the top of the bin and fold the excess over the top edge Press the liner down into the bottom corners of the bin Refer to Figure 4 6 Place the bin back in its location on the far right side of the deck with the handle toward the front Return the robot gantry to its home position with the Move Robot function O Check the waste liquid bottle If the liquid level is at or below the sensor change gloves and proceed with setup of next run If the liquid level is above the sensor follow the procedure for waste liquid disposal in the section for End of Day cleanup Section 4 9 3 4 26 500005363 02 4 Operation 4 9 3 End of Day Required materials Nitrile gloves Absorbent lab wipes Plate seals from accessory kit Disposal bags Waste tip bin liner Waste tip bin 196 v v sodium hypochlorite solution Commercial bleach undiluted 396 hydrogen peroxide do not use hydrogen peroxide from a container that has been open for longer than 8 days Eye protection e g face shield goggles etc Lab coat disposable or fresh
32. Extraction tube not emptied ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S At least one extraction tube was not emptied when expected or the run was aborted and fluid remained in the extraction tubes CORRECTIVE ACTION S Run the Disposal Protocol Configuration Maintenance Tools Manage Consumables Empty Extraction Tubes to empty the tubes If the Disposal Protocol does not complete successfully carefully remove the Extraction Tubes manually and dispose of as recommended in the Post run Cleanup instructions Section 4 9 2 EC 1013 Unexpected error ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S An unexpected error occurred during a run or Disposal Protocol CORRECTIVE ACTION S Effect The robot portion of a run is aborted The reader portion of the run continues if error occurs within the protocol Disposal protocols are permitted If error occurs during a Disposal Protocol it is aborted Future runs are permitted NOTE You must repeat the run if any portion was aborted 500005363 02 1 7 BD Viper Instrument User s Manual EC 2001 Priming heater temperature too low ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error
33. Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument failed to get or set positioning data from the robot CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted Robot End of Run activities are not performed The reader portion of the run in progress continues Disposal Protocol and Volume QC functions are aborted if in progress Future runs are permitted NOTE You must repeat the run if any portion was aborted No other corrective action is required If error recurs contact your local BD representative 500005363 02 1 25 BD Viper Instrument User s Manual EC 10011 Robot calibration required ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The robot has not been calibrated CORRECTIVE ACTION S Future runs are prohibited Contact your local BD representative EC 10012 cLLD check failure ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument reported a failure during the Daily Maintenance QC function This function runs automatically before a run s
34. THE RESTING TRACK POSITION THE DOOR WILL BE HEAVIER THAN YOU EXPECT IF THIS OCCURS BE SURE TO USE BOTH HANDS WHILE OPENING AND CLOSING THE DOOR IF THE DOOR MECHANISM CABLE FAILS WHILE THE DOOR IS OPEN AND IT IS NOT IN THE RESTING TRACK THE DOOR WILL FALL MAKE SURE YOU ALWAYS SET THE DOOR IN ITS RESTING TRACK WHEN OPENING THE DOOR AND ACCESSING THE INSTRUMENT DECK DO NOT ATTEMPT TO OPEN THE DOOR BEYOND THE STOP POSITION TO THE SERVICE POSITION DO NOT USE ANY MATERIALS WITH THE BD VIPER LT OR BD PRE WARM HEATER OTHER THAN THOSE SUPPLIED BY BD SPECIMEN RACKS SPECIMEN TUBES AND THE PRE WARM HEATER ARE HOT DURING PRE WARM PROTOCOLS AND UNTIL THE COOL DOWN OPERATION COMPLETES ALWAYS ALLOW THE COOL DOWN OPERATION TO COMPLETE BEFORE HANDLING SPECIMEN RACKS OR SPECIMEN TUBES OR THE PRE WARM HEATER ITSELF ACID AND BASE SPILL KITS SHOULD BE ON HAND IN THE EVENT OF A SPILL OF EXTRACTION REAGENTS THE EXTRACTION REAGENT TROUGH CONTAINS CORROSIVE SUBSTANCES BE SURE TO STORE TROUGHS UPRIGHT AT ALL TIMES USE OF PERSONAL PROTECTION EQUIPMENT SUCH AS NITRILE GLOVES EYE PROTECTION AND LAB COATS IS STRONGLY RECOMMENDED WHEN HANDLING THESE REAGENTS DO NOT PUNCTURE REAGENT TROUGHS OR REMOVE FOIL COVERS IF ANY LEAKAGE IS OBSERVED IN REAGENT TROUGH PACKAGING OR WITHIN THE BAGS DO NOT REMOVE THE TROUGH FROM THE BAG DISCARD THE BAG AND ALL CONTENTS IN ACCORDANCE WITH ALL FEDERAL STATE REGIONAL AND INSTITUTIONAL GUIDELINES SOLUTIONS CAN HAVE
35. Tempera ture Verification When the manual verification of the heat spike is complete tap the OK button to begin the cooldown operation Notification N800 i i The Pre warm Heater QC has Completed Successfully Heat temperatures Cool temperatures Primary QC Primary QC Heater 1 120 0 119 7 C Heater 1 21 7 21 7 C Heater 2 120 0 120 0 Heater 2 21 8 21 7 C Heater 3 120 0 120 0 Heater 3 22 3 22 0 C Heater 4 120 0 119 9 Heater 4 22 7 22 6 C Heater 5 120 0 120 1 C Heater 5 22 9 23 0 C Heater 6 120 0 120 0 C Heater 6 23 4 23 5 C Figure 6 19 Pre warm Heater QC Temperature Results 11 The Power and USB indicators remain lit during the QC and the Protocol in progress and Protocol complete indicators continue to flash during cooldown 12 When the cooldown is complete the results of temperature verification appear in a pop up window see Figure 6 19 for a sample of the result window Tap the print button if you want to print the temperature results to file in your QC log To close the window tap the OK button The Protocol in progress and Protocol complete indicators extinguish when cooldown is complete 13 The QC function status is displayed at the right of the menu selection H pass indicator fail aborted indicator 14 If a pass result is reported any Pre warm alert condition is cleared If fail is reported indi
36. alerts button pre warm heater button 500005363 02 BD Viper LT System User s Manual BD Viper LT V2 30A US MS fa 7 30 2013 Tuesday 4 26 PM Pre warm Heater w BD Figure 5 1 Main Status Display 5 4 500005363 02 5 Reference Main Status Display Fields Indicators Software Version Region Version is located to the right of the Instrument name top left of display This is a read only field showing the current software version in the form Vn nnX where n nn are numbers and X is a letter A region code appears to the right of the software version number and is shown in parentheses e g US EU etc The region is set at installation and cannot be changed by the user Assay availability may vary from region to region Instrument Number Instrument number is located below the Instrument name It is a read only field showing the num ber assigned to the instrument in Configuration gt Instrument LIS Status indicator LIS status is located at the top right of the display if enabled The icon appears normal white letter on green background if the LIS feature is enabled and the systems are communicating The icon appears cracked in half if the LIS feature is enabled but the systems are not commu nicating Door Locked Unlocked indicator The Door indicator is located at the top right of the display The lock appears closed if the door is locked The lock appears ope
37. algorithmic result in parentheses is provided to the right of the result symbol Refer to the assay package insert for additional information Negative H Liquid level failure specimen tube or extraction tube overflow at wash step Et Extraction transfer failure liquid error during extraction process other than wash PC Extraction control failure O Error system cannot obtain acceptable readings in any well in the test group C Assay result suppressed overlays assay icon Results for aborted runs and runs with Liquid Level Errors are not reported Report Footer Performed by date blank line for signature date Reviewed by date blank line for signature date P End of report indicator last page 500005363 02 5 43 BD Viper LT System User s Manual To Reprint the Tube Result Report From the Main Status display tap the reports menu button Highlight Tube Result Report Tap the print button The Rack Selection window appears showing the 30 most recently completed specimen racks see Figure 5 13 for a sample Rack Selection window for the Copy Rack function the window and icons are the same when Rack Selection appears for selecting a rack to print Scan the rack barcode or Highlight the desired specimen rack then tap the print button again 5 44 500005363 02 5 Reference BD Viper LTTM Tube Result Report 83 BD 10 25 2012 11657 Instriment 1 VLTPPO4 V
38. and re sealable cap etc Includes steps for lysis extraction purification that lead up to a solution sample processing that is ready to be tested steps are performed automatically on the instrument Conditions that are detected but typically are temporary alert provides self clearing alert information that condition occurred generally only requires acknowledgment compare to persistent alert notification single dispense test Assay with one analyte specimen is dispensed into only one microwell Biological material obtained from a patient for the purposes of a diagnostic specimen or 12 2 500005363 02 12 Glossary and Abbreviations Meaning Result that is marked by user to be suppressed from results reporting and suppressed result uploading to LIS Communication from the instrument about a condition that may require system alert user action correction or acknowledgment test type A specific analyte Time critical step when amplification plate from previous run has been replaced specimen has had heat spike while in the priming plate and transferred to the amplification plate followed by plate testing Transfer and Amplification step USB flash media used for importing assay definitions and exporting thumb drive results error logs etc USB Universal Serial Bus Mode in which a run is performed without user intervention all consumables and reagents ar
39. and soap and rinse thoroughly In case of contact with eyes rinse immediately with plenty of water and seek medical advice WARNING Never attempt to autoclave items cleaned with or possibly containing bleach WARNING Waste tips waste liquid reagent troughs extraction tubes and used microwells should be placed in sealable bags and disposed of in accordance with all federal state regional and institutional guidelines WARNING Waste liquid and solids waste tips should be emptied at the end of each day at a minimum WARNING Acid and Base Spill Kits should be on hand in the event of a spill of extraction Reagents 4 9 2 Post Run Required materials Specimen tube caps Black plate seals Disposal bags Waste tip bin liner Absorbent pads from reagent troughs 196 v v sodium hypochlorite solution Nitrile gloves Eye protection e g face shield goggles etc Lab coat disposable or fresh clean Procedure O Before starting the cleanup procedure read all cautions and warnings in Section 4 9 1 General Cleanup Cautions and Warnings O When the door unlocked icon appears on the display and the End of Robot Activities tone sounds open the BD Viper LT instrument door O Remove the specimen rack from the deck If you are running specimens in high throughput mode set the rack aside for recapping until after the next run has started 500005363 02 4 25 BD Viper LT System User s Manual
40. are returned to the QC menu 4 To abort the QC function while it is in progress tap the abort button In the confirmation win dow tap the Yes button to abort the function or tap the No button to proceed with the QC function 5 When the function is complete the status is displayed at the right of the menu selection H pass indicator fail aborted indicator 6 42 500005363 02 6 Maintenance 6 If results of fail are reported contact your local BD representative for assistance 6 2 4 10 Reader QC Reader QC can be performed to clear certain system alerts There is no setup involved to perform this function Reader QC takes about 9 minutes to complete To Access Reader QC From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab From the Tools menu tap the QC button E Qc Reader QC From the QC menu tap the Reader QC menu selection Reader QC Buttons start button abort button To perform Reader QC 1 Access the Reader QC function as described above 2 Tap the start button to initiate the QC function 3 1 the confirmation window tap the Yes button to proceed or tap the No button to cancel the function If you select No you are returned to the QC menu 4 To abort the QC function while it is in progress tap the abort button In the confirmation win dow tap the Yes button to abort
41. assigned location for single dual assays or the first test type entered if 2 compatible assays are run on the same rack Solid maroon indicates the second assay when 2 compatible assays are run on the same rack Solid light gray indicates the next available location Solid dark gray indicates an unused location The first available position for a patient specimen is C1 Tap the C1 icon The Specimen Login window Figure 4 2 appears Accession Rehydrate External control Save Cancel Report results V V GCQx J Figure 4 2 Specimen Login Window 11 Type in or scan the specimen s accession number barcode Accession number is an optional entry Accessions can be up to 20 characters but cannot contain these characters 2 12 Ifthe tube is an optional QC tube make one of the following selections e the Rehydrate checkbox to tell the instrument to rehydrate the tube In the Lot Number field scan or type in an optional lot number up to 20 characters Select either the Positive or Negative radio button Tap the Save button to save the information e the External control checkbox to tell the instrument to rehydrate the tube you are going to manually rehydrate it In the Manafacturer Id field enter optional information about the External control In the Lot Number field scan or type in an optional lot number u
42. can be aborted whenever the abort buttons are active Abort process has been initiated but has not yet Abort Pending completed Aborted Abort process has completed 4 6 2 Run Statuses Once a run has begun it exists in one of 2 primary statuses e Robot Portion after QC tubes have been punctured until last transfer of specimen to amplification wells has been made until the reader door closes robot continues clean up afterward e Reader Portion after the reader door closes 500005363 02 4 19 BD Viper LT System User s Manual 4 7 Starting a Run After specimens have been logged in and the BD Viper LT instrument has been prepared you can begin the run NOTE Never attempt to manually pipette specimens Specimen tubes and Priming amplification microwells do not corre spond one to one Make sure the desired specimen rack is inserted in the instrument and that the instrument s door is closed From the Main status display tap the start run button If you have inserted the specimen rack in the rack station the instrument scans the rack s barcode the Start Run display appears A prompt at the top of the display states Click Start to begin testing tube rack n barcode mmmmm If you have not inserted the specimen rack in the rack station the instrument issues an alert that the barcode cannot be read and presents the Rack Selection display Place the desired rack in the rack station
43. clean Graduated cylinder to measure bleach and water volumes Neutralization pouch Waste bottle Absorbent pads from reagent troughs Alcohol pad or 7096 Isopropanol Procedure O Before starting the cleanup procedure read all cautions and warnings in Section 4 9 1 General Cleanup Cautions and Warnings 9 Follow all Post Run cleanup steps described above CJ If you use an optional Lighted Login station remove the tube alignment block and clean by submerging it in 196 v v sodium hypochlorite solution for 2 3 minutes Rinse the block thoroughly with tap water and allow to air dry Wipe the rest of the station with a lab wipe dampened with 196 v v sodium hypochlorite or 396 hydrogen peroxide Follow with a lab wipe dampened with tap water Do not submerge the base of the Login station Rinse both items thoroughly with tap water and allow to air dry 9 Dampen a lab wipe with 1 v v sodium hypochlorite or 3 hydrogen peroxide and wipe the handheld barcode scanner Follow with a lab wipe dampened with tap water 9 Dampen a lab wipe with 1 v v sodium hypochlorite or 3 hydrogen peroxide and wipe the surface of the Pre warm heater Follow with a lab wipe dampened with tap water O Remove and discard any empty pipette tip boxes O Remove and clean the touchoff plate see Figure 4 9 by wiping it with a lab wipe soaked in 196 v V sodium hypochlorite solution Rinse thoroughly with water and allow to air dry 50000
44. consumable check if a predefined period of time has passed and you have not manually run the function CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted if Daily Maintenance was executed at the beginning of a run The reader portion of the run in progress continues Future runs are prohibited NOTE You must repeat the run if any portion was aborted Error may be corrected by re running Daily Maintenance Configuration Maintenance gt Tools gt QC Functions gt Maintenance Daily If error persists contact your local BD representative EC 10013 Pressure check failure ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument reported a failure during the Daily Maintenance QC function This function runs automatically before a run s consumable check if a predefined period of time has passed and you have not manually run the function 7 26 500005363 02 7 Troubleshooting CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted if Daily Maintenance was executed during a run The reader portion of the run in progress continues Future runs are prohibited NOTE You must repeat the run if any portion was aborted Error may be corrected by re running Daily Maintenance Configuration Maintenance
45. entered The assay is shown at the top of the dis play and the layout of microwells is shown in the center of the display Assays show both Priming and Amplification plates See Figure 5 7 for the main Plate Layout display When you tap a plate on the main Plate Layout display a zoomed in plate display appears See Figure 5 9 for the zoomed in display Asterisks indicate a new lot number has been assigned and not yet saved You can print the Plate Layout display by tapping the print button To Access Plate Layout From the Main Status display tap the rack operations button From the Rack Operations menu tap the rack login button and log in the specimen tubes From the Rack Login display tap the plate layout button or from the Start Run Confirmation display tap a plate layout graphic 500005363 02 5 17 BD Viper LT System User s Manual Barcode 12345 Created 09 20 13 1 32 14 PM Figure 5 7 Plate Layout Display The Priming plate appears on the left the Amplification plate appears on the right 5 18 500005363 02 5 Reference Plate Layout Icons and Buttons indi rehydrated specimen indicator plate layout indicator overlays well location positive control indicator negative control indicator overlays well location overlays well location priming microwells ORO amplification microwells empty microwell location new unsaved lo
46. first assay group occupied specimen location with all results reported second assay group available location unavailable location positive control overlays tube location negative control overlays tube location CTQx GCQx specimen with only CTQx result reported GCQx result suppressed CTQx GCQx specimen with only GCQx result reported CTQx result suppressed add QC pair button remove QC pair button PP PN eo plate layout button extraction lot button rehydrate specimen icon overlays tube location print Tube Layout report button Rack Login Display Fields Rack Number When a rack is logged in the instrument assigns a number to the rack This number appears at the top left of the display above the rack login indicator This is a read only value The rack number may be from 1 to 30 If 30 racks are Ongoing logged in but not yet tested or have completed testing but not been uploaded to the LIS if LIS communications is enabled no more racks can be defined until at least one rack or more is deleted completes testing or is uploaded to the LIS Rack Barcode Scan the barcode on the BD Viper LT instrument specimen rack The barcode is located on the top of the specimen rack cover and is a 5 digit number there is also a barcode on the inside of the cover This barcode is how the instrument identifies the specimen rack The rack barcode must be unique among Ongoi
47. has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The priming plate temperature was too low for a specific portion of a run SDA or during Prime Heater QC CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted The reader portion of the run continues Future runs are prohibited If error occurs during Prime Heater QC the QC fails NOTE You must repeat the run if any portion was aborted To correct the problem run Prime Heater QC Configuration Maintenance Tools QC Functions Prime Heater QC If problem persists contact your local BD representative EC 2003 Priming heater temperature too high ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The priming plate temperature was too high for a specific portion of a run or during Prime Heater Qc CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted The reader portion of the run continues Future runs are prohibited If error occurs during Prime Heater QC the QC fails NOTE You must repeat the run if any portion was aborted To correct the problem run Prime Heater QC Configuration Maintenance gt Tools gt QC Functions gt Prime Heater QC If problem persists contact your local BD representative EC 200
48. instrument 500005363 02 6 1 BD Viper LT System User s Manual 6 2 Routine Maintenance Below is a schedule of recommended maintenance activities These activities are described in the sec tions noted Post run Post run cleanup Section 4 9 2 Daily e Check printer paper Section 6 2 1 e Run Tools gt QC gt Daily Maintenance Section 6 2 1 e Check Pre warm heater LEDs Section 6 2 1 e Check optional Lighted Login rack LEDs Section 6 2 1 End of Day cleanup Section 4 9 3 Weekly e Run Tools gt QC gt Weekly Maintenance Perform weekly cleaning Section 6 2 2 Monthly Replace Plate Seal suction cup s Section 6 2 3 Replace air filter Section 6 2 3 e Monitor for DNA contamination Section 6 2 3 As Needed e Save Data to USB Section 6 2 4 1 Install Software Section 6 2 4 2 Manage Consumables Section 6 2 4 3 Register Barcode Scanner Section 6 2 4 4 e Move Robot Section 6 2 4 5 e Calibrate Touchscreen Section 6 2 4 6 e Magnet QC Section 6 2 4 7 e Pre warm Heater QC thermal verification Section 6 2 4 8 e Prime Heater QC Section 6 2 4 9 e Reader QC Section 6 2 4 10 e Robot QC Section 6 2 4 11 e Volume QC Section 6 2 4 12 e Clean Barcode Scanner Window Section 6 2 4 13 e Access Cable I O Panel Section 6 2 4 141 6 2 500005363 02 6 Maintenance 6 2 1 Daily Maintenance 6 2 1 1 Check Printer Paper Refer to the manufacturer s operating
49. location and complete the fields as described below and in Section 4 4 1 Specimen tubes must be added consecutively across the rows from left to right and from the bottom row to the top A1 B1 C1 For step by step information on logging in specimen tubes and QC tubes refer to Section 4 4 1 500005363 02 BD Viper LT System User s Manual m 12345 ta Last Tube D01 CONTROLZRUS A w 000000 0600000 000000 000000 000000 06200000 Lot Numbers QC CTQx GCQx 01 01 1234567 Ext Tube 01 CTQx Well GCQx Well Plate 1 A01 F03 1232434 Plate 1 A02 F04 4654646 Figure 5 3 Rack Login Display 5 12 500005363 02 5 Reference Rack Login Display Buttons delete all logged tubes button Tap to delete all logged tubes from the display A message box appears asking you to confirm that you want to delete all logged tubes Tap Yes to delete all logged tubes or tap No to exit the message box without deleting all tubes If there are multiple test types on the rack the first time you tap the delete all logged tubes button tubes for the last test type are deleted Tap the delete all logged tubes button a sec ond time to delete tubes for the first test type add remove QC pair button Tap to add a QC control pair to the rack When a second pair of controls is added a second assay cannot be added to
50. next set of nga thrgudhput mode specimens while current samples are being read LED Light Emitting Diode a solid state light emitting semiconductor device LIS Laboratory Information System Assay with more than 2 analytes each specimen is dispensed into more multi dispense test than Amicrowells notification Message that requires user action for the instrument to proceed pending result A result that has not yet been sent to the LIS Condition detected by the instrument may indicate hardware failure or persistent alent run related failure compare to notification and self clearing alert plate set A priming plate and corresponding amplification plate Set of two Quality Control tubes positive and negative used to verify the QC pair kit row Designated by letters A H Sulphorhodamine derivative a commonly used fluorescent dye with HOS absorbance and emission maxima at 349 and 460 nm respectively Instrument related activities sample preparation lysis extraction SDA testing reagent disposal Specimen that has been prepared for diagnostic testing Strand Displacement Amplification Includes the steps involved in preparing the specimen for processing also referred to as pre analytical preparation steps are assay dependent and sample preparation typically might include inserting and breaking the collection swab in the specimen tube capping the specimen tube with a penetrable
51. not correct the problem cycle instrument power 500005363 02 7 27 BD Viper Instrument User s Manual If error persists contact your local BD representative EC 12002 Extractor magnets failed to reach top ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument was unable to detect that the extraction magnets returned to their top position CORRECTIVE ACTION S Effect During instrument initialization a system alert is generated and the instrument initialization continues The robot portion of a run in progress is aborted However run does not have aborted status since specimen processing did not begin due to the error The reader portion of the run in progress continues Future runs are prohibited Error may be corrected by running Magnet QC Configuration Maintenance Tools QC Func tions Magnet QC If this does not correct the problem cycle instrument power If error persists contact your local BD representative EC 12003 Extractor magnets failed to move from home ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument was unable to detect that the extrac
52. of the front pipette tip boxes 9 Verify that all specimen tubes have the appropriate pierceable caps For cytology specimens verify that all LBC Specimen Dilution Tubes have the appropriate blue pierceable caps in place 10 Verify that there are the same number of Extraction tubes as specimen tubes and that they are in the same locations in both racks 500005363 02 4 17 BD Viper LT System User s Manual 11 12 13 14 15 16 17 18 Verify that the extraction rack cover is in place over the rack Load the extraction rack into the extraction station at the right front of the instrument deck The station has guide pins over which the rack fits Verify that the specimen rack cover is in place and fully seated over the rack Load the pre warmed specimen rack into the rack station at the front center of the interior deck To load the rack barcode end is inserted first press and hold down the white button at the front left of the station and slide the rack in Make sure the rack is fully inserted the button should click when the rack is in place Make sure that both the amplification stage reader and priming heater are free of any debris Change gloves Load the amplification plate on the reader amplification stage The reader is located on the left side of the instrument midway to the back The SDA plate adapter fits into the amplification stage in one orientation only Load the priming plate on t
53. or key to increase or decrease the setting then press SELECT again to save the setting If there is no display on the monitor verify that the monitor power is on press and hold the power but ton at the far right of the button panel for 3 seconds If power is on check brightness and contrast set tings to see if they require adjustment Finally navigate through the menu to the Input Select option and verify that DVI Digital is selected shown in black text Power should be turned off only when advised by a BD representative or if a safety hazard with the monitor exists To turn power off press the power button and hold until the countdown is complete then release the button 500005363 02 3 11 BD Viper LT System User s Manual 3 9 USB Ports Two USB ports are located behind the monitor These ports are intended primarily for use with USB flash drives When advised by BD a blank USB flash drive can be inserted to allow you to save data to the drive Also software updates may be distributed on flash media See Figure 3 10 Figure 3 10 USB Ports 3 12 500005363 02 3 Controls and Indicators 3 10 Temperature QC Thermal Tool An optional thermal QC tool kit can be purchased to assist in performing manual temperature verifica tion during Pre warm Heater QC The kit consists of two adapters that go into heater wells a tempera ture sensor that you place in the adapter and a handheld digital ther
54. or if the operation fails to complete successfully Refer to Section 7 Troubleshooting for additional instructions CAUTION Do not remove the USB flash media during the update process Failure to follow this instruction could render your instrument inoperable 6 26 500005363 02 6 Maintenance 6 24 3 Manage Consumables The Manage Consumables functions enable you to execute robot pipettor based functions related to emptying extraction tubes reagent troughs and consolidating pipette tip boxes The Manage Consum ables functions can be run whenever the robot portion of any run is complete and there are no system alerts that would prohibit them from executing Both the Empty Reagent Troughs and Empty Extraction Tubes functions can be selected and run together See Figure 6 14 To Access the Manage Consumables Functions From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab From the Tools menu tap the manage consumables button Manage Consumables Buttons start button abort button Ww reset tip counters button Manage Consumables Icons e Empty Reagent Troughs icon up Empty Extraction Tubes icon Consolidate Pipette Tips icon 500005363 02 6 27 BD Viper LT System User s Manual To Empty Reagent Troughs Extraction Tubes 1 Access the Manage Consumables function as described above 2 the
55. specimen rack can be submerged in a solution of sodium hypochlorite as recommended in Sec tion 4 9 Cleanup Figure 3 3 Specimen Rack Top View open 500005363 02 3 5 BD Viper LT System User s Manual Figure 3 4 Specimen Rack Side View open 500005363 02 3 Controls and Indicators 3 5 Extraction Rack The Extraction rack consists of a rack base and removable cover that holds extraction tubes in place for sample processing See Figures 3 5 and 3 6 To remove the cover slide it to the right then lift the left end and remove it from the base To replace the cover insert it in the slot on the right side Lower the cover down over the base and then slide the cover to the left The Extraction rack can be submerged in a solution of sodium hypochlorite as recommended in Sec tion 4 9 Cleanup Figure 3 5 Extraction Rack cover removed 500005363 02 3 7 BD Viper LT System User s Manual Figure 3 6 Extraction Rack removing cover 3 6 BD Pre warm Heater For information on use controls and indicators refer to the separate manual BD Pre warm Heater Manual 8086781 3 8 500005363 02 3 Controls and Indicators 3 7 Lighted Login Station The optional Lighted Login station is used during tube login to assist you in properly placing tubes in the specimen rack As each tube is logged in a blue LED lights on the station indicating whe
56. the rack A maximum of 4 Viper LT QC pairs can be added to a rack see Section 4 4 1 Logging in QC and Specimen Tubes for additional information on logging in QC pairs When a QC pair has been added the button changes to remove QC pair Tap to remove the last QC pair added to the rack plate layout button Tap to access the Plate Layout display Refer to Section 5 4 1 1 for additional information extraction login button Tap to access the Extraction Lot Login display Refer to Section 5 4 1 2 for additional informa tion print tube layout report button Tap to print the Tube Layout Report Refer to Section 5 7 1 for additional information exit button Tap to exit the display The rack is saved automatically All required fields must be completed for a rack to be saved Tube Login Window Fields Buttons Accession Scan or type in the specimen s accession Accessions can be up to 20 characters excluding the following characters Accession is optional do have to be unique to each specimen logged 500005363 02 BD Viper LT System User s Manual Specimen Tube Login EO1 ae Accession Rehydrate 1 External control Delete Cancel Report results Y CTQx GCQx Figure 5 4 Tube Login Window Rehydrate checkbox Check this box if the tube is an optional QC tube and you want the in
57. thoroughly with tap water and allow to dry For all other parts wipe with 1 v v sodium hypochlorite or 3 hydrogen peroxide then rinse with tap water Door Handle Extraction Station Specimen Rack Station and Lock Release Button Priming Heater Plate Seal Station Amplification Heater Remaining deck surfaces including tip waste area Wipe with 3 hydrogen peroxide followed by tap water Plate Seal Tool Suction Cups Plate Seal Station Pins Alcohol pad 13 2 500005363 02 Frequency Location Tip Sleeves Stop Discs Cleaning Agent Procedure DI water Channel check square Wipe with 3 hydrogen peroxide followed by tap water Tip Waste Bin Wipe with 1 v v sodium hypochlorite followed by tap water Pipette Tip Rack Metal tips Reagent Trough Rack Submerge in 1 v v sodium hypochlorite solution for 2 3 min Rinse thoroughly with tap water Allow to air dry Monthly Replace plate seal tool suction cups Replace the suction cups then clean each suction cup with a fresh alcohol wipe Inspect clean air filter Wipe filter cover with lab wipe moistened with 396 hydrogen peroxide Rinse with lab wipe moistened with tap water Dry cover before replacing Wash dirty filter in mild detergent Place on paper towels and dry thoroughly if you are going to reuse them immediately 500005363 02
58. to drop down a window containing years Tap the desired year to select that year s log files to be exported Select All button Tap to select all checkboxes in the Log Files window Unselect button Tap to clear all checkboxes in the Log Files window Reader Files Window Reader Configuration checkbox Check to export reader configuration information 500005363 02 6 23 BD Viper LT System User s Manual Reader Logs checkbox Check to export reader log files Reader Data and Images checkbox Check to export raw reader data and image files Robot Files Window Robot Export Files checkbox Check to export trace and log files created by the robot soft ware These files are used by BD to diagnose instrument issues 6 24 500005363 02 6 Maintenance 6 2 4 2 Install Software From time to time updated instrument software region rules and or assay definitions may be provided to you These software updates are provided on one or more USB flash drives with the name of the type of software printed on the label Instrument software can only be installed to the same or a higher version You cannot install an older version of software including assay files on the instrument Configuration settings databases alerts and results system log and installed assays are retained when the software is updated Updated assay definition files are in effect from the time of the update forw
59. tool pipettor and extractor magnets excess waste liquid tips required reagents trough lockdowns in correct position e touchoff plate Priming plate If any of these items is amiss a message informs you to correct the condition After you cor rect the condition and acknowledge it return to Step 2 to restart the run Next the instrument checks plate height and plate seal height using a tip WARNING NEVER ATTEMPT TO OPEN THE DOOR WHILE THE DOOR LOCKED INDICATOR IS DISPLAYED 6 You can continue with other system functions while the run is progressing such as logging in specimen tube racks To view the progress of the run tap the run status button on the Main Status display 7 If you selected Walkaway mode you do not have to interact with the instrument until the door is unlocked and the readers have completed testing the amplification plate 8 If you selected High Throughput mode the following steps occur e instrument transfers specimens from the specimen tubes to the extraction tubes Necessary reagents are added to the extraction tubes and the extraction process occurs e instrument transfers specimens from the extraction tubes to the priming microwells 500005363 02 4 21 BD Viper LT System User s Manual e Next a message appears stating The next step is timing critical This is known as the Transfer and Amplification Message You have approximately 30 minutes to
60. tubes can be logged in or 48 CTQ or GCQ mixed single assay tubes can be logged in per rack See Figure 5 3 You cannot exit the Rack Login display which automatically saves the rack if any of the information below is missing e Atleast one QC pair e Insufficient QC pairs e QC and assay kit lot numbers and expiration dates e Extraction tube lot number and expiration dates e Rack barcode To exit the display either enter the required information or tap the clear all tubes button and confirm that you want to clear all information entered for the tubes During tube login when you tap a tube location the Tube Login window pops up In this window you can enter an accession select whether the specimen gets rehydrated or is an External control sup press results for multiple test assays and delete individual logged in tubes Refer to Tube Login Win dow Fields Buttons and Figure 5 4 below To print a Tube Layout Report tap the print Tube Layout report button The report is described in Section 5 7 1 To Access Rack Login From the Main Status display tap the rack operations button From the Rack Operations menu tap the rack login button 500005363 02 5 9 BD Viper LT System User s Manual Rack Login Display Icons and Buttons rack login indicator button indicator shows instrument assigned rack number delete all logged tubes button occupied specimen location with all results reported
61. typing in the date or by tapping the calendar button to the right of the field and tapping the desired date If desired date is not in view tap lt to display the previ d ous month Tap to display the next month you can not select a later month than the current one Tap the month name to pop up a listing of months within the current year If the desired month is showing tap it to select it If the desired month is within a different year tap the year to pop up a window of the years available for selection Tap the desired year to select it then tap the desired month within that year When the desired month is showing tap the desired date to populate the field The Start Date must be ear lier than the End Date EE UM NN Defaults to current date Enter the End Date as described above for the Start Date End Date must be later than the Start Date and it cannot be later than the current date Tap the drop down arrow at the far right of the field to Test Group Type select the desired test group type This field defaults to the first alphabetical type in the list if there is more than one type of test group type Insert a flash drive in a USB port and tap the save data to USB button Tap Yes to proceed or No to cancel the export message informs you when the export is 4 T d p 9 y p complete Tube Export Parameters Start Date 07 01 2013 G End Date 08 01
62. your local BD representative EC 20001 DIO board failed to initialize ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The Power Distribution IO Board failed to initialize or did not respond to communication attempts CORRECTIVE ACTION S The Remote Alarm is disabled while the error is active Other devices that rely on the DIO board do not function while error is active Future runs are prohibited Remove Cable I O Panel Section 6 2 4 14 and check all USB cable connections If error persists contact your local BD representative EC 20002 Unable to communicate with DIO board ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S Instrument is unable to communication with Power Distribution IO Board CORRECTIVE ACTION S The Remote Alarm is disabled while the error is active 7 34 500005363 02 7 Troubleshooting Future runs are prohibited Cycle instrument power If error persists contact your local BD representative EC 21003 Pre warm heater failure to reach cooldown temperature ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b
63. 02 6 Maintenance 6 To abort the QC function while it is in progress tap the abort button In the confirmation win dow tap the Yes button to abort the function or tap the No button to proceed with the QC function 7 When the function is complete the status is displayed at the right of the menu selection H pass indicator fail aborted indicator 8 If results of fail are reported contact your local BD representative for assistance 500005363 02 6 45 BD Viper LT System User s Manual 6 2 4 12 Volume QC The Volume QC function can be used to assist you in verifying the accuracy of pipetting volumes by the robot Volume QC pipettes 3 different volumes of liquid into empty specimen tubes You weigh the tubes before and after the pipetting operation and perform calculations to verify pipetting accuracy Accuracy of the pipettor can only be verified by completing the procedure provided below The function is only available when the instrument is idle For detailed instructions see Volume QC Procedure below To Access Volume QC From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab QC From the Tools menu tap the QC button Volume QC From the QC menu tap the Volume QC menu selection Volume QC Procedure The pipettors are calibrated at the factory and are rechecked during instrument installation R
64. 2 6 2 4 6 Calibrate Touchscreen Function 6 35 6 2 4 7 Magnet 6 38 6 2 4 8 Pre warm Heater QC instrument thermal verification 6 39 6 2 4 9 Prime Heater QC 6 42 6 2 4 10 Reader OC uiid Libia 6 43 6 2 4 11 Robot QGis 6 44 624 12 Volume QC una 6 46 02 413 on IERI Clean Barcode Scanner Window6 49 62414 Lese einer ce ebd be abd Accessing the Cable I O Panel6 49 7 Troubleshooting Fol General 7 1 7 1 1 Instrument Serita terere ae 7 1 4 2 System MCSSAGES ta 7 2 7 3 Error Message Li dg Lact 7 3 8 Limited Warranty 9 Maintenance Log 10 Ordering Information 11 US Contact 12 Glossary and Abbreviations 13 Cleaning Reference vi 500005363 02 Preface Figures Figure Title Page Figure 1 1 BD Viper LT 1 1 3 Figure 1 2 BD Viper LT Instrument Interior SDA run 1 4 Figure 1 3 Main Status 1 1 6 Figure 1 4 Symbols Used on the BD Viper LT Instrument 1 8 Figure 2 1 Main Status 2 5 Figure 2 2 Instrument
65. 21 BD Viper LT System User s Manual 5 4 1 2 Extraction Lot Login The Extraction Lot Login display enables you to login extraction tubes This function is typically per formed during Rack Login The display is accessed via the Rack Login display The extraction lot login button is grayed out unless a specimen tube is logged in On the Extraction Lot Login display extraction tubes are color coded dark gray See Figure 5 10 To enter or modify an extraction tube lot number tap a tube location The Modify Extraction Tube Lot window appears Figure 5 11 Scan or type in the extraction tube lot number 7 digits and expiration date YYYY MM DD and tap the save button to save the information You can also update lot information from the Start Run display See Section 5 5 for additional informa tion Asterisks indicate new extraction tube lot number assigned but not yet saved To Access Extraction Lot Login From the Main Status display tap the rack operations button From the Rack Operations menu tap the rack login button and log in the specimen tubes alternately you can access the display via the modify rack button From the Rack Login display tap the extraction lot login button Extraction Lot Login Icons and Buttons extraction tube icon extraction tube button unsaved lot number icon jh extraction lot login icon 5 22 500005363 02 5 Reference a 5
66. 3 02 1 1 BD Viper LT System User s Manual The BD SDA assays are based on the amplification and detection of target DNA using amplification primers and a fluorescent labeled detector probe The SDA priming and amplification microwells are formatted as break off strips and contain dried reagents For SDA the processed sample is added to the priming microwell which contains the amplification primers fluorescent labeled detector probe and other reagents necessary for amplification After incubation the reaction mixture is transferred from the priming microwell to the amplification microwell which contains enzymes a DNA polymerase and a restriction endonuclease necessary for SDA The SDA amplification microwells are sealed and then the reader door closes Next amplification and detection occur Results are reported automatically based on the algorithm identified in the assay specific reagent package insert s The instrument has 2 modes of operation Walkaway mode where the user loads all consumables and specimens onto the instrument and returns when the run has completed and High Throughput mode where the instrument pauses after sample preparation is complete and before amplification detection begins to allow consumables for the next run to be loaded In this mode while the current run is being tested specimens for the next run can be prepared for testing When the run is complete a Result Report prints automatically showing the resul
67. 3210 Priming Well Plates 3 440494 Printer 441407 Rack Extraction 442964 Rack Specimen 442965 Rack Tip Holder 443225 Remote Alarm Unit 441000 Scanner Handheld Barcode 441364 Software Region Rules IVD Application Viper LT CTQx GCQx Assay 443156 443155 443157 Thermal Tool Digital Thermometer Probe 441333 Thermal Tool Adapter 441995 Thermometer Digital Probe 441630 Tip Waste Bin 443228 Touchoff Plate 443231 USB cable 443195 10 2 500005363 02 10 Ordering Information Catalog Number USB flash drive 8 GB blank 441989 User s Manual BD Pre warm Heater 441879 User s Manual BD Viper LT System 443506 Waste Liquid Bottle 443233 Disposables BD Viper LT Pipet Tips 8x5x96 441996 Dilution tubes LBC 400 tubes 441444 Microwells empty 8 trays 440752 Neutralization Pouch 12 441354 Plate Seals Black 480 440984 Swab Diluent 48 tubes 441361 Accessory Kit 80 optically clear plate seals 80 black plate seals 80 disposal bags 442958 Waste Liner Bags 100 442968 Extraction Materials Extraction Tubes 384 tubes 441129 Extraction Reagent Lysis Trough and piercing tool 12 441994 500005363 02 10 3 BD Viper LT System User s Manual 10 4 500005363 02 11 US Contact BD 7 Lo
68. 4 2 4 3 4 4 4 5 4 6 4 7 4 8 4 9 ele 4 1 Using the Instrument 4 4 2 Preparing Specimens 1 4 2 Logging in Specimen TUbES ii 4 3 4 4 1 Logging in and Specimen 4 3 4 4 2 Extiaction Lot 4 8 4 4 3 Setting up Plates ia 4 10 44 31 PASSAYS ioe epic E 4 10 4 4 4 Pre warming 4 12 l reparing the Instr imient i rte reb ten iii 4 14 4 5 1 DCUM leet 4 14 Rack and RUM StatuseS edere ibd elia ici 4 19 4 6 1 Rack JC MITT D 4 19 40 2 Statuses eicere e DARE Reese SEDE Na APO 4 19 Starting a BID iiis erii nunca rade ii 4 20 Responding to Alarms and Errors 4 23 ehm cp B 4 24 4 9 1 General Cleanup Cautions and Warnings sse 4 24 4 9 2 POSt RUM Ln 4 25 4 9 3 Of DAY S 4 27 4 9 4 Weekly Cleaning DE 4 31 49 5 Aborted Run Cleanup t teet eene pesi eee dae rrt ena deel 4 31 4 9 5 1 Consumables Cleanup essent 4 31 4 9 5 2 Spills Cleanup rrr aa
69. 5 Priming heater RTD failure ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared T 500005363 02 7 Troubleshooting and b the error has been acknowledged by tapping the OK button in the popup alert window NOTE Error may self clear if cause is resolved POSSIBLE CAUSE S A general temperature failure of the priming heater system has occurred CORRECTIVE ACTION S Effect The robot portion of the run in progress is aborted The reader portion of the run continues Future runs are prohibited If error occurs during Prime Heater QC the QC fails NOTE You must repeat the run if any portion was aborted To correct the problem run Prime Heater QC Configuration Maintenance Tools QC Functions Prime Heater QC If problem persists contact your local BD representative EC 2006 Priming heater RTD variance ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S There is a temperature variance between the primary and secondary RTD that is greater than the defined tolerance The Priming heater may be out of calibration CORRECTIVE ACTION S Effect Future runs are prohibited If error occurs during Prime Heater QC the QC fails To correct the problem run Prime Heater QC Configuration Maintenance
70. 5363 02 4 27 BD Viper LT System User s Manual Figure 4 9 Touchoff Plate O Waste bottle cleaning If waste volume in bottle is above the sensor see Figure 4 11 follow the steps immedi ately below If the waste volume is below the sensor skip to the next square bullet e Unscrew the cap and pour approximately 400 mL of undiluted commercial bleach directly into the waste bottle Pour the liquid slowly to prevent splashing e Disengage the quick release on the waste tubing and remove the waste bottle Agitate the waste container by twisting wrist back and forth 15 20 times while holding the bottle by the handle Prior to disconnecting the sensor cable ensure the alignment markings are present on both ends of the cable as shown in Figure 4 10 Figure 4 10 Sensor Cable Markings Disconnect the sensor cable by unscrewing the connector see Figure 4 11 Allow to sit for at least 30 minutes After at least 30 minutes unscrew the waste liquid bottle lid and remove 4 28 500005363 02 4 Operation Hold the waste container by the handle with one hand and hold the bottom of the container with the other hand to assist in pouring the liquid waste down a sink drain Follow with plenty of running tap water Note Keep the quick release valve connection away from the side to which the waste liquid is poured Rinse the bottle with tap water Dampen a lab wipe with 196 v v sodium hypoc
71. A STRONG CAUSTIC EFFECT INCLUDING SEVERE BURNS ON SKIN AND MUCOUS MEMBRANES AVOID CONTACT WITH THE EYES AND SKIN AVOID BREATHING FUMES VAPORS OR SPRAY HARMFUL IF SWALLOWED DO NOT EAT OR DRINK IN THE VICINITY OF THESE REAGENTS IN CASE OF CONTACT IMMEDIATELY REMOVE CONTAMINATED CLOTHING IMMEDIATELY WASH SKIN WITH WATER AND SOAP AND RINSE THOROUGHLY IN CASE OF CONTACT WITH EYES RINSE IMMEDIATELY WITH PLENTY OF WATER AND SEEK MEDICAL ADVICE THE ROBOT GANTRY MOVES WITH CONSIDERABLE VELOCITY AND FORCE NEVER ATTEMPT TO DEFEAT OR OVERRIDE THE DOOR INTERLOCK SWITCH SERIOUS USER INJURY CAN RESULT BE CAREFUL OF PINCHING FINGERS WHEN CLOSING THE DOOR BE SURE THE PRIMING HEATER IS FREE OF DEBRIS AND THE PRIMING MICROWELLS ARE SEATED PROPERLY PRIOR TO STARTING THE RUN NEVER ATTEMPT TO OPEN THE DOOR WHILE THE DOOR LOCKED INDICATOR IS DISPLAYED When the instrument notifies you of alerts and errors you should immediately respond to the condition 500005363 02 1 Introduction WARNING Pathogenic microorganisms including Hepatitis viruses and Human Immunodeficiency Virus may be present in clinical specimens Standard Precautions and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids Clinical and Laboratory Standards Institute 2005 Approved Guideline M29 A3 Protec tion of laboratory workers from occupationally acquired infections 3rd ed CL
72. From the Main Status display tap the configuration maintenance button the Tools tab From the Tools window tap the manage consumables button 500005363 02 4 31 BD Viper LT System User s Manual On the Manage Consumables display click the Empty Reagent Troughs and Empty Extraction Tubes menu selections The Consolidate Pipette Tips selection is highlighted automatically when either of the menu options is selected the start button Follow the on screen instructions and tap the yes button when you are ready to proceed To abort the disposal protocol tap the abort button Read and heed any on screen alerts regarding the terminated disposal process The Disposal Protocol display shows an aborted icon below the portions of the protocol that were aborted e Follow the on screen instructions at the completion of the Disposal Protocol One of the following statuses is reported at the completion A pass indicator H aborted indicator e Follow Viper End of Run Cleanup activities if you have not already done so 4 9 5 4 Cleaning Priming Stage If fluid is on the Priming heater stage follow this procedure e Remove the priming plate from priming heater Seal the plate remove and place microwells in a resealable bag Dispose in biohazard trash Prepare fresh cleaning solution 196 v v sodium hypochlorite solution in a container large enough to sub
73. HE DOOR IS OPEN AND IT IS NOT IN THE RESTING TRACK THE DOOR WILL FALL MAKE SURE YOU ALWAYS SET THE DOOR IN ITS RESTING TRACK WHEN OPENING THE DOOR AND ACCESSING THE INSTRUMENT DECK DO NOT ATTEMPT TO OPEN THE DOOR BEYOND THE STOP POSITION TO THE SERVICE POSITION 3 Controls and Indicators 3 4 Specimen Rack The BD Viper LT specimen rack is used to hold specimen tubes securely during specimen processing The rack holds 48 tubes in a 6 row numbers 1 6 by 8 column letters A H layout This layout matches the lettered row and numbered column layout of the Tube Login display Tubes are held in place by a cover that pivots down over the tubes after they have all been placed in the rack See Figures 3 3 through 3 4 The specimen rack contains an identifying barcode located on the underside of the cover You can scan the top barcode during Rack Login to identify the specimen rack being logged in The Pre warm heater s barcode scanner reads this barcode to select the pre warm protocol for the assay s logged in for the rack Also the instrument s fixed barcode scanner reads the barcode when it is placed in the specimen rack station to confirm that the rack has been pre warmed The cover pivots up to allow placement and removal of tubes When the cover is open it rests in an open position to allow you to scan the rack barcode see Figure 3 3 When it is closed it secures the tubes for specimen processing operations The
74. HOLD appears above the decimal digit of the temperature reading Minimum Maximum Temperature Button Press this button to show the minimum or maximum reading that the probe has measured since the last time power was applied Press once to show the minimum temperature The word MIN appears to the T right of the temperature reading Press again to show the maximum temperature The word MAX appears to the right of the temperature reading Press again to return the display to the current temperature reading Degrees Celsius Fahrenheit Button C F Press this button to switch between degrees Celsius and Fahrenheit By default the temperature is displayed in degrees Celsius 500005363 02 3 13 BD Viper LT System User s Manual Figure 3 11 Thermal Tool Overall View Handheld electronic unit at left plate based sensor at top center adapters 2 at right PROBE INPUT Figure 3 12 Thermal Tool Top View Connector from temperature probe plugs into input jack 3 14 500005363 02 3 Controls and Indicators 3 11 Onscreen Keyboard Fields that accept alphanumeric information e g Accession Lot Number activate an onscreen key board that enables you to tap the desired characters to enter them into the field To access the onscreen keyboard tap the field In alohanumeric fields the alphabetic keyboard caps pops up See Figure 3 13 In numeric only fields the numeric key
75. ICIES AND PROCEDURES FOR THE PROPER HANDLING OF FLAMMABLE MATERIALS To Pre warm Specimens You can pre warm a specimen rack whenever the instrument is idle performing extraction or cleanup performing a disposal protocol processing waste solids via the move robot function or you are logging in a specimen rack A pre warm protocol cannot be initiated when QC functions are being performed or when the Pre warm heater is not at or below 40 C its ready tempera ture Both the instrument and Pre warm heater must be turned on and interconnected and the desired rack must be logged in to perform a pre warm protocol 1 Put new gloves on 2 Turon the Pre warm heater if it is not already on 3 Place the controls and specimens in the specimen rack and log them in as described in Section 4 4 Do not rehydrate run Controls 4 Place the specimen rack onto the Pre warm heater The Attention indicator lights 5 heater scans the rack barcode to determine if the rack has been logged in and to determine which assay specific protocol to use for the rack The protocol begins automatically if the rack has not already been pre warmed If the rack has been pre warmed previously a message informs you and you can choose to re warm the specimen rack Specimens may not be pre warmed more than two times If the heater cannot read the rack barcode the pre warm button becomes active Tap the pre warm button to access the Rack Selection disp
76. ING SEVERE BURNS ON SKIN AND MUCOUS MEMBRANES AVOID CONTACT WITH THE EYES AND SKIN AVOID BREATHING FUMES VAPORS OR SPRAY HARMFUL IF SWALLOWED DO NOT EAT OR DRINK IN THE VICINITY OF THESE REAGENTS IN CASE OF CONTACT IMMEDIATELY REMOVE CONTAMINATED CLOTHING IMMEDIATELY WASH SKIN WITH WATER AND SOAP AND RINSE THOR OUGHLY IN CASE OF CONTACT WITH EYES RINSE IMMEDIATELY WITH PLENTY OF WATER AND SEEK MEDICAL ADVICE 6 Remove the extraction reagent trough from the bag Load the trough at the right rear of the instrument deck The puncture tool should be at the left as you load the trough Load the rear of the trough first then lower the front down into place Turn the two lockdowns toward the rear to hold the trough down Do not peel or puncture the foil cover 4 16 500005363 02 4 Operation Figure 4 7 Extraction Trough Lockdowns 7 Peel both sides of a clear Viper LT plate seal and place the sticky side down on the plate seal station Do not push down on the seal and do not flex it The plate seal station is located to the right of the priming stage Amplification Priming Plate Plate we Extraction m Reagente Plate eee p Seal Specimen Extraction Rick 4 i f Pipette 2 it 7 nd bed 8j Waste Liquid Disposal Station Figure 4 8 Instrument Layout 8 Verify that the 2 plate seal tools are located in their station to the right
77. LERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The optional Lighted Login station did not respond to a configuration command or to communica tion attempts during a QC operation CORRECTIVE ACTION S Do not use the optional Lighted Login station while this error is still active Check USB cable between instrument and Lighted Login station and reattach if needed If error persists contact your local BD representative 500005363 02 7 33 BD Viper Instrument User s Manual EC 19002 Lighted Login station IO error ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The optional Lighted Login station did not respond to a configuration command or to communica tion attempts during a QC operation CORRECTIVE ACTION S Do not use the optional Lighted Login station while this error is still active Error may be corrected by running Sample Login Station QC Configuration Maintenance gt Tools gt QC Functions gt Sample Login Station QC Check USB cable between instrument and Lighted Login station and reattach if needed If this does not correct the problem cycle instrument power If error persists contact
78. O OGF Page 1 Rack 6 10251 CTQx GC Qx Extacten Dube Lava 1111111 11412020 InmghLar7 58221 782013 wr 00400 Kit 1111111 11 11 2020 Tube Accession CTOx QC 111111 j T1 A1 2011 OK 420 1393 mi ge 1111111 11A12011 17 21 174 1403 1399 n 1343 1704 1342 1123 120 m 440 BEPRBHBI E ami 1530 1704 197 4518 rae 392 1679 2 248 m e bs 142 110 TS YT3 9V9 PETRI E 1408 1192 amy 1782 1134 8n 1190 1340 Um 1153 1020 1344 10m 234 1247 ped nm 1301 1020 100 Or Or Or e Or Ge Or Or Or Or Or Oe ot Or Or 9 99999999 Date Date Figure 5 20 Sample Tube Result Report p 1 of x 500005363 02 5 45 BD Viper LT System User s Manual 5 7 3 Temperature History Report The Temperature History Report provides up to one year of information on priming warming and reader temperatures during runs You can print a Temperature History Report at any time from the Reports menu A sample Temperature History Report is shown in Figure 5 21 To Print the Temperature History Report From the Main Status display tap the reports menu button Temperature History
79. Reader function to access the reader Access the Move Robot Reader function as described above The open close reader button changes state according to the current state of the reader To open the reader tap the open reader button Perform the desired cleaning or plate removal activities a amp WO N To close the reader tap the close reader button 6 34 500005363 02 6 Maintenance 6 2 4 6 Calibrate Touchscreen Function If the touchscreen does not seem to accurately register your taps on the screen you can use the Cali brate Touchscreen function to recalibrate it The Calibrate Touchscreen function presents a series of targets that you tap If there is a difference between the location you tap and the target s actual coordi nates the difference is saved and the offset is used to interpret subsequent screen taps The function can be performed at any time See Figures 6 17 and 6 18 To Access the Calibrate Touchscreen Function From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab From the Tools menu tap the calibrate touchscreen button Calibrate Touchscreen Buttons ue target button Jf calibration complete button redo button To Calibrate the Touchscreen 1 Access the Calibrate Touchscreen function as described above 2 Tap the target buttons as they appear Try to be as precise as you c
80. SI Wayne Pa Garner J S 1996 Hospital Infection Control Practices Advisory Committee U S Depart ment of Health and Human Services Centers for Disease Control and Prevention Guide line for isolation precautions in hospitals Infect Control Hospital Epidemiol 17 53 80 3 U S Department of Health and Human Services 1999 Biosafety in microbiological and biomedical laboratories HHS Publication CDC 4th ed U S Government Printing Office Washington D C Directive 2000 54 EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work seventh individual directive within the meaning of Article 16 1 of Directive 89 391 EEC Official Journal L262 17 10 2000 p 0021 0045 CAUTIONS Do not use Alconox or Eliminase for cleaning Do not spray or pour cleaning solution on any part of the deck or stages heaters Do not apply cleaning solution to the pipette adapters or robot Do not move the robot gantry or pipettor by hand WARNING Never attempt to autoclave items cleaned with or possibly containing bleach WARNING Waste tips waste liquid reagent troughs extraction tubes and used microwells should be placed in sealable bags and disposed of in accordance with all federal state regional and institutional guidelines WARNING Waste liquid and solids waste tips should be emptied at the end of each day at a mi
81. Surface No direct heat Light lt 5000 lux 500005363 02 2 Installation Environmental Requirements Evaluated for safety to 6562 ft 2000 m Altitude Assay performance evaluated to 5280 ft 1609 m Use of earthquake anchoring is strongly recommended in locations susceptible to earthquake activity Installation Category Il and Pollution Degree 2 as per IEC 664 Thermal Specifications 100 C gt 9 min not to Pre warm heater fluid temperature CTQ GCQ exceed 115 gt 8 min Priming heater fluid temperature CTQ GCQ 70 C 2 0 C Amplification heater fluid temperature 52 5 C 1 0 Temperature Accuracy 0 75 C Temperature Uniformity 0 75 C Extractor Specifications 48 extraction tubes in 6 rows 1 6 Extractor module layout by 8 columns A H Up Position Field Strength 2800 Gauss Home Down Position Field Strength lt 100 Gauss Optical Specifications Set 1 Set 2 Wavelength Green Orange Channel Channel Excitation 460 480 nm 575 597 nm Emission 505 515 610 630nm Maximum optical crosstalk lt 0 5 Set 1 Fluorescent dyes detected in this channel include FAM Set 2 Fluorescent dyes detected in this channel include ROX Cal Fluor Red 610 500005363 02 BD Viper LT System User s Manual 2 3 Instrument Installation 2 3 1 Site Preparation The BD Viper LT instrument should be in
82. You must observe the sequence to note if any of the LEDs is not operational Pre Warm Station LED QC takes less than a minute to complete To Access Check Pre warm Heater LEDs function From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab From the Tools menu tap the QC button Pre Warm Station LED QC From the QC menu tap the Pre Warm Heater LED QC menu selection Check Pre warm Heater LEDs Buttons start button abort button To Verify Pre warm Heater LEDs 1 Verify that the Pre warm heater is connected to the Viper LT instrument and that it is turned on solid green LED Access the Check Pre warm Heater LEDs function as described above Tap the start button to initiate the QC function In the confirmation window tap the Yes button to proceed or tap the No button to cancel the function If you select No you are returned to the QC menu 5 To abort the QC function while it is in progress tap the abort button In the confirmation win dow tap the Yes button to abort the function or tap the No button to proceed with the QC function 500005363 02 6 5 BD Viper LT System User s Manual 6 When idle the Pre warm heater LEDs Power USB are illuminated as follows 7 The LED QC function lights the 3 remaining LEDs protocol protocol complete and attention indicators in a serial then parallel fl
83. a rack for testing either a scan the rack barcode or b tap the desired rack in the selection window then tap the start run button On the Start Run Confirmation display Figure 5 15 tap the start run button again to confirm that you want to start testing the rack Walkaway checkbox The Start Run Confirmation display contains a Walkaway checkbox The box is checked enabled or unchecked disabled depending on the value set in Configuration Maintenance gt Instrument tab To process the run in Walkaway mode make sure the Walkaway checkbox is checked and there is no run currently being processed To process the run in High Throughput mode make sure the Walkaway checkbox is unchecked Walkaway mode enables the instrument to perform a complete run without pausing to allow you to enter new materials for another run as you would in High Throughput mode In High Throughput mode the instrument can be setup to begin a new run while the plate is being tested in the reader 5 32 500005363 02 5 Reference Card Status Window This function is not enabled for instruments distributed in the U S This window enables you to view the current status of the key card reader and any key card that is inserted in the reader The status is updated dynamically Plate and Extraction images The Priming and Amplification plate images at the bottom of the display and the Extraction rack image on the deck allow you to access the corr
84. above the Status Bar at the left of the Pre warm Heater window The rack number assigned by the instrument and rack barcode that is located on the rack are shown Status Bar The status bar at the left of the Pre warm Heater window displays status messages and timers related to the pre warm function The following statuses may appear No Comm the instrument cannot communicate with the Pre warm heater pre warm button is inactive Idle no rack has been placed on the heater no protocol is in progress pre warm button is inactive Attention a rack has been placed on the heater but the protocol has not been initiated pre warm button is active pre warm heater has an active alert pre warm button is not active hh mm ss a pre warm protocol is in progress hours minutes and seconds for the protocol are displayed in the progress bar progress bar fills in green as protocol progresses pre warm button is inactive Resetting hh mm ss a pre warm protocol has been aborted hours minutes and seconds remaining are displayed pre warm button is inactive Complete the pre warm protocol has completed Pre warm Heater Window Button pre warm button The pre warm button at the right of the Pre warm Heater window allows you to initiate a pre warm protocol manually if the rack barcode cannot be read 500005363 02 5 Reference 5 4 Rack Operations Menu The Rack Operations menu ena
85. accomplished with or without user intervention depending on the alert You can access the list of persistent alerts from the Main Status display by tapping the instrument alert button To review the text message associated with a persistent alert tap the alert in the alert window then tap the View Alert Text button below that window The alert text describes what has occurred to cause the alert and the consequences to any runs in progress and other instrument operations In addition the listing in Section 7 3 provides additional suggestions for resolving the error condition Messages are identified by a letter and number in the title bar of the message window Messages that begin with N are Notification messages and are informational Messages that begin with Q are Questions requesting a response from you in order to determine what to do Messages that begin with W are Workflow errors that require you to observe the error condition and correct it before the instru ment can proceed Remote Alarm Unit The BD Viper LT instrument supports use of the optional Remote Alarm unit The Remote Alarm is activated whenever a System Alert occurs when the Transfer and Amp Step message occurs and when the robot portion of the run is complete after clean up completes alarm sounds for 30 seconds When these messages are acknowledged by tapping the ok button in the message the Remote Alarm is silenced deg 500005363 02 7 Tr
86. ach excessive temperatures which can affect results and equipment longevity The air filter can be cleaned and reused See Figures 6 11 and 6 12 To remove and clean the air filter 1 2 3 The air filter is located on the left side of the instrument Change gloves To remove the air filter you must first remove the filter cover To remove the cover locate the recessed area at the bottom center of the cover Insert your fingertips into the recessed area and pop the bottom of the cover out Lower the top part of the cover away from the instrument Wipe the cover with paper towels or gauze moistened with 396 hydrogen peroxide Rinse with paper towels or gauze moistened with tap water Dry the cover before replacing You can now remove the filter Wash dirty filters in a mild detergent Place them on paper towels and dry them thoroughly if you are going to reuse them immedi ately To save time you can replace dirty filters with a spare clean set Wash dry and set aside the removed dirty filters for the next filter replacement 6 18 500005363 02 BD Viper LT System User s Manual 6 2 4 As Needed Maintenance The following as needed maintenance procedures are discussed in this section e Save Data to USB Section 6 2 4 1 Install Software Section 6 2 4 2 e Manage Consumables Section 6 2 4 3 e Register Barcode Scanner Section 6 2 4 4 e Move Robot Reader Section 6 2 4 5 Calibra
87. afety in microbiological and biomedical laboratories HHS Publication CDC 4th ed U S Government Printing Office Washington D C Directive 2000 54 EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work seventh individual directive within the meaning of Article 16 1 of Directive 89 391 EEC Official Journal L262 17 10 2000 p 0021 0045 2 CAUTIONS Do not use Alconox or Eliminase for cleaning Do Do Do NOT use bleach or sodium hypochlorite solution on any areas unless specified not spray or pour cleaning solution on any part of the deck or stages heaters not apply cleaning solution to the pipette adapters or robot 4 24 500005363 02 4 Operation Do not move the robot gantry or pipettor by hand WARNING The extraction reagent trough contains corrosive substances Use of personal protection equipment such as Nitrile gloves eye protection and lab coats is strongly recommended when handling these reagents Solutions can have a strong caustic effect including severe burns on skin and mucous mem branes Avoid contact with the eyes and skin Avoid breathing fumes vapors or spray from reagents and waste liquids Harmful if swallowed Do not eat or drink in the vicinity of these reagents In case of contact immediately remove contaminated clothing Immediately wash skin with water
88. ain Follow with plenty of running tap water Note Keep the quick release valve connection away from the side to which the waste liquid is poured Rinse the bottle with tap water Dampen a lab wipe with 196 v v sodium hypochlorite solution and wipe the outside surface of the waste bottle Rinse with a lab wipe dampened with tap water Allow the bottle to sit upside down on absorbent material overnight Replace the bottle with a clean dry waste liquid bottle Add a Viper Neutralization Pouch to the bottle and replace the lid e Reattach the quick release valve to the waste tubing and reposition the waste bottle under the Viper LT instrument Change gloves Dampen a lab wipe with 396 hydrogen peroxide solution for the following cleaning steps Note Do not use hydrogen peroxide from a bottle that has been open for longer than 8 days Note Do NOT use bleach or sodium hypochlorite solution on any of the following areas unless specified Change lab wipe and wipe the entire surface of the extraction station Change lab wipe and wipe the remaining entire surface of the right side of the deck Move to the left side of the deck change lab wipe and wipe the priming heater and surround ing areas Change lab wipe and wipe the plate seal station Change lab wipe and wipe the specimen rack station and the surrounding area Dampen lab wipe with 396 hydrogen peroxide and wipe the reader door the amplification heater and
89. al station Change lab wipe and wipe the specimen rack station and the surrounding area e Change lab wipe and wipe the remaining pipette tip tray surfaces Change lab wipe and wipe the amplification stage heater and surrounding area NOTE Make sure that the BD Viper LT plate heater is free of debris The presence of debris such as bits of paper gauze etc will interfere with temperature uniformity and pipetting accuracy Change lab wipe and wipe the outside of the quick release on the waste tubing with 196 v v sodium hypochlorite After 2 3 minutes change gloves and repeat the round bullet steps immediately above with lab wipe dampened with tap water Change lab wipe as previously indicated Make sure that traces of cleaning solution are rinsed away Repeat the rinse step if necessary O Clean the plate seal tool suction cups and the pins on the plate seal station with an alcohol pad O Clean the entire work area including counter tops with 1 v v sodium hypochlorite on a daily basis Thoroughly rinse with water Allow surfaces to dry completely before proceeding with additional testing C Replace any empty pipette tip stations with full tip boxes before starting next run Leave 4 30 500005363 02 4 Operation partial boxes in place CJ For additional information refer to the assay specific package insert 4 9 4 Weekly Cleaning For the weekly cleaning procedure refer to Secti
90. allows you to consolidate tip boxes that are currently on the instrument and are mapped by the instrument software when the instrument was unable to auto matically consolidate tip boxes due to circumstances such as a robot alert 1 2 3 5 Access the Manage Consumables function as described above Tap the Consolidate Pipette Tips menu selection The instrument consolidates tip boxes so that one partially filled and the rest empty or full boxes remain after the operation is complete When the function is complete the status is displayed at the right of the menu selection H completed indicator not completed aborted indicator Remove and dispose of any empty tip boxes 6 30 500005363 02 6 Maintenance 6 2 4 4 Register Barcode Scanner Function The Register Barcode Scanner function enables you to register a new or replacement barcode scan ner for use with the BD Viper LT instrument The function can be performed at any time See Figure 6 15 To Access the Register Barcode Scanner function From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab register barcode scanner i b de button sample barcode to scan Scan barcode u 123456789012 To Register a Barcode Scanner 1 Access the Register Barcode Scanner function as described above 2 Tap the scan barcode button 3 Scan the sample barcode on t
91. an when tapping the tar gets When the function is complete tap the screen in several places blank areas Tap the calibration complete button if the cursor tracks your finger accurately If the cursor does not track your finger accurately tap the redo button to start the calibration Over 500005363 02 6 35 BD Viper LT System User s Manual Touch targets from position of normal use Figure 6 17 Calibrate Touchscreen Display 6 36 500005363 02 6 Maintenance Touch the screen Does the cursor follow your finger Figure 6 18 Calibrate Touchscreen Confirmation Display 500005363 02 6 37 BD Viper LT System User s Manual 6 2 47 Magnet QC The Magnet QC function can be used to attempt to clear certain system error conditions by testing the movement of the extractor magnets The function is only available when the instrument is idle Magnet Diagnostics take less than 1 minute to complete To Access Magnet QC From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab From the Tools menu tap the QC button Magnet QC From the QC menu tap the Magnet QC menu selection Magnet QC Buttons start button abort button To perform Magnet QC 1 Access the Magnet QC function as described above 2 start button to initiate the QC function 3 In the confirmation window tap the
92. and homogenize the specimen After cooling the specimens are loaded onto the BD Viper LT instrument The pre warmed specimen is transferred to an extraction tube that con tains ferric oxide particles in a dissolvable film For SDA assays a high pH is used to lyse the bacterial cells and to liberate their DNA into solution Acid is then added to lower the pH and induce a positive charge on the ferric oxide which in turn binds to the negatively charged DNA The particles and bound DNA are then pulled to the sides of the extraction tube by magnets and the unbound material is aspi rated to waste The particles are washed and a high pH elution buffer is added to recover the purified DNA Finally a neutralization buffer is used to bring the pH of the extracted solution to optimum condi tions for amplification of the target The BD Viper LT instrument transfers extracted specimens and Positive and Negative assay controls to plates containing SDA priming microwells A warming step in each prime microwell insures specific hybridization of SDA primers to target if present after which the reaction mixture is transferred to a corresponding gray SDA amplification microwell The plates are then sealed with a plate seal Once the plate is sealed the onboard reader door closes over the plate Next amplification and detection occur Results are reported automatically based on the algorithm identified in the assay specific reagent package insert s 50000536
93. and restart the run If the barcode that is scanned matches the one selected the run begins If the specimen rack barcode cannot be read by the onboard scanner the instrument issues an alert that the barcode cannot be read and presents the Rack Selection display Tap the desired rack in the list then tap the start run button to restart the run Before responding check the instrument to insure that everything is set up properly as described in previous sections If there is no run in progress decide whether you want to execute the run in Walkaway mode the entire run is processed without user intervention or High Throughput mode the instru ment pauses and allows you to remove the old sealed amplification plate and insert a new one for the next run For Walkaway mode make sure the Walkaway checkbox is checked for High Throughput mode make sure the Walkaway checkbox is unchecked 4 20 500005363 02 4 Operation 5 To begin the run tap the start button The instrument verifies that the door is closed checks for expired consumables unreadable trough barcodes and the presence of the extraction rack If any of these items is amiss a message informs you to correct the condition For the first 2 items the run continues placing the extraction rack requires you to start the run again Next the instrument activates the door latch and checks the following items pipette tips plate seal plate seal
94. anner is mounted in a stand that is typically placed near the monitor or on the bench where specimen tubes are logged in If the scanner is giving read errors when attempting to scan you can try cleaning the scanner window To clean the window use a lint free non abrasive cloth dampened with water CAUTION DO NOT USE alcohol acetone or abrasive cleaners to clean the barcode scanner window Dry the window with a dry lint free non abrasive cloth 6 2 4 14 Accessing the Cable I O Panel From time to time you may need to access the cable input output I O panel which is located beneath the door To remove the panel grasp the edges of the panel and pop the panel off by pulling it toward you To replace the panel make sure no cables are routed out the top or sides of the panel all cables should be routed out the bottom of the panel Align the mounting pins on the panel with the holes on the instrument frame Push in at the locations to pop the mounting pins into the holes 500005363 02 6 49 BD Viper LT System User s Manual 6 50 500005363 02 7 Troubleshooting T 1 General 7 1 1 Instrument Service If your BD Viper LT instrument malfunctions or operates unusually in any way you may initially attempt to solve the problem by following the recommendations in this section All other servicing attempts will terminate the responsibility of the manufacturer under the terms of the warranty If you cannot c
95. ard CAUTION Scan all USB flash drives with anti virus software prior to inserting them into a BD Viper LT instrument USB port To Update the Instrument Software From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab If multiple USB flash drives are provided they must be installed in the following order VIPER LT REGION RULES VIPER LT IVD APPLICATION e VIPER LT xyz ASSAY FILE where xyz is an actual assay name NOTE If more than one assay file USB drive is provided these may be installed in any order Insert the first update drive From the Tools menu tap the update software button o Follow onscreen instructions that appear If more than one USB flash drive is provided when the first installation completes insert the next flash drive in the order listed above and repeat the installation process Repeat until all the USB flash drives are installed 500005363 02 6 25 BD Viper LT System User s Manual The instrument verifies that a valid software update is present on the flash media then it begins the update process Progress of the operation is shown in a progress bar at the bottom of the display When the update is complete the instrument may reboot some types of update do not require a reboot Error codes are generated if the flash media does not contain an installation file
96. ashing pattern 8 Verify that all LED indicators illuminate Make a notation and contact your local BD representa tive if any of the LEDs does not light 9 When the function is complete the status is displayed at the right of the menu selection This status indicates only that the instrument succeeded or did not succeed in completing the func tion not that the LEDs are all operational You must visually confirm the operation of the LEDs during the QC function H completed indicator not completed aborted indicator 6 6 500005363 02 6 Maintenance 6 2 1 4 Check Lighted Login Rack LEDs The Sample Login Station QC function consecutively lights all the LEDs of the optional Lighted Login station You must observe the full sequence to note if any of the LEDs is not operational Sample Login Station QC takes less than a minute to complete To Access Sample Login Station QC function From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab QC From the Tools menu tap the QC button Sample Login Station From the QC menu tap the Sample Login Station QC menu selection Check Lighted Login Station LEDs Buttons start button abort button To Verify Lighted Login Station LEDs 1 Verify that the Lighted Login station is connected to the Viper LT instrument 2 Access the Sample Login Station QC function as described above 3 Tapt
97. aste failure ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument was unable to eject one or more tips from the pipettor after a second attempt CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted Robot End of Run activities are not performed Disposal Protocol and Volume QC functions are aborted if in progress The reader portion of the run in progress continues Future runs are prohibited NOTE You must repeat the run if any portion was aborted 500005363 02 7 21 BD Viper Instrument User s Manual Run Robot QC to clear the error Configuration Maintenance Tools QC Functions Robot QC If tip eject is successful Robot QC passes run Consumables Management Disposal Protocols to dispose of hazardous extraction materials Configuration Maintenance Tools Manage Con sumables Empty Reagent Troughs Empty Extraction Tubes If error persists or tip eject fails Robot QC fails contact your local BD representative EC 9006 Tip pick up problem ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument failed to acquire tips on the firs
98. ayout of the instrument cabinet is shown in Figure 3 1 Individual components are illustrated in figures accompanying the related text The following controls and indicators are discussed e Main power switch Section 3 2 e Door Section 3 3 e Specimen rack Section 3 4 Extraction rack Section 3 5 BD Pre warm heater Section 3 6 Lighted Login station Section 3 7 Monitor Touchscreen Section 3 8 USB Ports Section 3 9 Thermal tool Section 3 10 Onscreen keyboard Section 3 11 Audible tones and alarms Section 3 12 WARNING ALL SYSTEM USERS MUST BECOME THOR OUGHLY FAMILIAR WITH ALL CONTROLS AND INDICATORS BEFORE ATTEMPTING TO OPERATE THE SYSTEM 500005363 02 3 1 BD Viper LT System User s Manual BD Viper LT Monitor Power Touchscreen Switch Barcode Scanner Figure 3 1 BD Viper LT Instrument Layout Door 500005363 02 3 Controls and Indicators 3 2 Main Power Switch The main instrument power switch is located on the left side of the instrument at the lower rear The main power switch is a two position rocker switch When the bottom part of the switch is pressed power is removed from the instrument When the upper part of the switch is pressed power is applied to the instrument For normal operation the power should remain on at all times except during some maintenance procedures Initialization and instrument startup take approximately 5 minut
99. bles you to select functions related to tube specimen racks such as defining new racks modifying copying and deleting existing racks Rack Operations can be per formed after instrument initialization is complete Individual functions such as logging in or modifying tube racks are covered in detail immediately following this section You must have at least assay enabled in Instrument Configuration in order to access the Rack Operations menu Buttons within the Rack Operations menu may be active or grayed out depending on whether Ongo ing Completed Aborted racks exist in the database to modify copy or delete See Figure 5 2 To Access the Rack Operations menu From the Main Status display tap the rack operations button Rack Operations Menu Icons and Buttons rack operations indicator rack login button modify rack button copy rack button delete rack button 500005363 02 5 7 BD Viper LT System User s Manual LEY Figure 5 2 Rack Operations Menu a 500005363 02 5 Reference 5 4 1 Rack Login Display Rack Login enables you to login new specimen tube racks Rack Login is always enabled The display is shown as a graphic representation of a specimen rack Specimens are logged in by selecting a loca tion Column A H Row 1 6 entering an optional Accession entering required lot number informa tion and saving the information Up to 32 CTQ GCQ dual assay
100. board pops up See Figure 3 14 To enter text or numbers tap the desired characters The text is shown in the field When finished tap the Enter key Functional keys e To erase one or more characters tap the Backspace key move the cursor left without erasing tap the key e move the cursor right without overtyping tap the gt key To move to the start of the field tap the Home key To move to the end of the field tap the End key Tolock CAPS tap the Caps Lock key An indicator lights on the key to show that Caps Lock is engaged To move to the next field tap the TAB key e To enter the text into the field tap the ENTER key Figure 3 13 Onscreen Keyboard 2 4 4 em Backspace Figure 3 14 Numeric Keyboard 500005363 02 3 15 BD Viper LT System User s Manual 3 12 Audible Tones and Alarms Six different types of sounds are generated by the BD Viper LT instrument as you perform operations Each of the sounds is unique These tones are designed to keep you informed about various opera tional states of the instrument Example Question Enter trough lot number Single high pitch bwip Notification Pre warm A pre warm protocol has Single chord complete completed Print screen Print screen button was pressed Camera shutter Run complete Reader s have completed the test Two rapid high pitch beeps
101. carrier Repeat cleaning and monitoring procedures until negative results are obtained 4 10 Power Failures If a power failure occurs the test run is aborted When power is restored the instrument restarts the graphical user interface GUI and waits for authorization to initialize the robot After you authorize ini tialization see CAUTION below the robot expels any liquid in the pipette tips into the waste liquid container and disposes of the pipette tips in the tip waste bin NOTE Do not attempt to manually remove tips after a power failure Do not attempt to manually pipette from the prim ing to the amplification plate CAUTION If the instrument loses power reboots observe the pipettor If there is a tip on the adapter closest to the front of the instrument in order to avoid damage to the pipettor make sure that the extraction reagent trough lockdowns in the open position see Figure 4 7 before authorizing robot initialization BD recommends the use of an Uninterruptible Power Supply UPS to address power conditioning and protect against power outages Any UPS used on the BD Viper LT instrument must provide full pure sine wave power not square wave and must be rated for at least 2200VA A minimum runtime of 10 minutes at a load of 1700VA is appropriate for protection from short duration power interruptions For 500005363 02 4 33 BD Viper LT System User s Manual protection against longer po
102. cator or notification message contact your local BD representative for assistance 6 40 500005363 02 6 Maintenance Manual Temperature Verification a When the cooldown message appears record the readout of the digital thermometer for tube location D1 b Within 30 sec move the thermocouple probe from tube location D1 to tube location D2 c Move the thermal tool adapter from tube location D1 to tube location D3 d After 5 min record the readout of the digital thermometer for tube location D2 e Within 30 sec move the thermocouple probe from tube location D2 to tube location D3 f Move the thermal tool adapter from tube location D2 to tube location D4 g After 5 min record the readout of the digital thermometer for tube location D3 h Within 30 sec move the thermocouple probe from tube location D3 to tube location D4 i Move the thermal tool adapter from tube location D3 to tube location D5 j After 5 min record the readout of the digital thermometer for tube location D4 k Within 30 sec move the thermocouple probe from tube location D4 to tube location D5 Move the thermal tool adapter from tube location D4 to tube location D6 m After 5 min record the readout of the digital thermometer for tube location D5 n Within 30 sec move the thermocouple probe from tube location D5 to tube location D6 o Move the thermal tool adapter from tube location D5 to tube location D1 p After 5 min record the readout of the dig
103. cel entering lot number expiration information The Modify Extraction Tube Lot window closes and you are returned to the Tube Login display Modify Extraction Tube Lot 01 Extraction Tube Lot Number Expiration Date 1234567 2012 02 29 Save Cancel Figure 5 11 Modify Extraction Tube Lot Window Extraction Lot Login Buttons extraction tube button Tap any assigned tube location to pop up the Modify Extraction Tube Lot window You can enter or modify the lot number or expiration date of the extraction tubes trough exit button Tap to exit the display Newly entered information is saved automatically 5 24 500005363 02 5 Reference 5 4 2 Modify Rack Display The Modify Rack display enables you to modify any Ongoing racks racks that have been defined and saved but not yet tested that have not yet been pre warmed You can add or delete specimens from the rack add or change accession numbers and modify kit numbers QC lot and Reagent You can only modify the Assay to a compatible determined by the assay definition file The Modify Rack display looks and operates exactly like the Rack Login display for additional information refer to Rack Login Display Section 5 4 1 Note that if a specimen rack has not yet been saved then you can make modifications within the Rack Login display itself The Modify Rack display is shown in Figure 5 12 To Access the M
104. ck Login display Section 5 4 1 The remaining 3 reports functions can be accessed from the Reports menu To print a report tap the reports button from the Main Status display tap the desired report s in the Reports menu enter any required parameters then tap the print button In addition to the 4 reports the Export Tube Demographics function allows you to export data for a range of tests into a CSV file on a USB flash drive See Section 5 7 5 for additional information The Reports menu is shown in Figure 5 18 The individual reports are discussed in detail in the sections noted above 5 38 500005363 02 5 Reference GI Tube Result Report Temperature History Search by Accession Number Export Tube Demographics Figure 5 18 Reports Menu 500005363 02 5 39 BD Viper LT System User s Manual 5 7 1 Tube Layout Report The Tube Layout Report shows the physical layout of specimen tubes and controls for the tube rack currently displayed on the Rack Login display The report is formatted to print on one page landscape orientation and shows the accession number for each specimen tube and its rack location Positive and negative QC controls along with their lot numbers and rack locations are shown also A sample Tube Layout Report is shown in Figure 5 19 The Tube Layout Report can only be printed from the Rack Login display To Print the Tube Layout Report F
105. ction 6 2 4 3 Start the Volume QC procedure as described above To Access Volume QC When the instrument is done pipetting fluid the status is displayed at the right of the menu selection H pass completed indicator fail aborted indicator 6 Carefully remove each capped specimen tube from the instrument and reweigh them Reweigh the individual tubes within 30 minutes of dispensing Record the final weights on the Log as described above Subtract the initial weight from the final weight for each tube 8 Evaluate Pass Fail based on the specifications on the Log column value falls outside specifications the entire test must be repeated e Repeat the test using new weighed tubes e Ifthe Volume QC procedure fails the re test contact BD for service 500005363 02 6 47 BD Viper LT System User s Manual BD Viper LT Volume QC Log Rows Columns Row 1 Initial Weight Row 1 Final Weight Row 1 Difference Row 1 Initial Weight Row 1 Final Weight Row 1 Difference Row 2 Initial Weight Row 2 Final Weight Row 2 Difference 1 mg 1 uL Transfer Set Volume acceptance criterion for each well 50 uL 1096 200 uL 10 1000 uL 10 Corrective Actions 6 48 500005363 02 6 Maintenance 6 2 4 13 Clean Barcode Scanner Window The handheld sc
106. d pushing the channel side to side or front to back 3 Using a damp lint free lab wipe wipe the outside of the channel sleeve black section see Fig ure 6 7 with nuclease free distilled or deionized water Note Make sure the wipe is dampened with water Do not soak the wipe and be sure to wring out excess water prior to wiping the tip channel sleeves stop discs and o rings 4 Lift up the sleeve and with a damp lint free lab wipe gently clean the end of the pipette head stop disc and the black o ring see Figure 6 8 6 12 500005363 02 6 Maintenance Figure 6 7 Tip Adapter Sleeves Figure 6 8 Tip Adapters Sleeves Manually Retracted 500005363 02 6 13 BD Viper LT System User s Manual 10 11 12 13 Gently push the pipet head back up to the home position Repeat sleeve and head cleaning for each position Remove the tip waste bin Remove the waste bag Wipe the bin with a lab wipe dampened with 196 v v sodium hypochlorite Rinse by wiping with tap water Lightly dampen a lint free lab wipe with 3 hydrogen peroxide and use it to gently wipe the inner collar of each metal tip Then wipe the outside of each metal tip Lightly dampen a new lint free lab wipe with DI water and use it to gently wipe the inner collar of each metal tip Then wipe the outside of the metal tip with the same new lab wipe Repeat step 9 Thoroughly dry the inner collar of each metal tip with a lint f
107. definitions and buttons are presented in Section 5 Reference Functions which cannot be performed buttons or icons are grayed out When you access a data entry field an onscreen keyboard pops up For information on the onscreen keyboards refer to Section 3 11 The indicators buttons shown below are common to most displays and menus door locked door unlocked LIS enabled GI LIS enabled offline communicating exit button 4 3 Preparing Specimens Specimens should be collected transported and prepared according to the instructions in the assay specific reagent package inserts Cytology specimens should be placed in blue Liquid Based Cytology LBC Specimen Dilution Tubes and capped with blue LBC Specimen Dilution Tube Caps 4 2 500005363 02 4 Operation 4 4 Logging in Specimen Tubes Logging in Specimen Tubes Summary 4 4 1 Log in required QC tubes Section 4 4 1 Log in specimen tubes Section 4 4 1 Log in extraction tubes Section 4 4 2 Set up microwell plates Section 4 4 3 Pre warm specimens Section 4 4 4 Logging in QC and Specimen Tubes Access Rack Login Display see Figure 4 1 1 2 Change gloves From the Main Status display tap the rack operations button The Rack Operations menu appears Tap the rack login button The Rack Login display appears Figure 4 1 shows the display with tubes logged in Addi tional information on the Rack L
108. der may have failed CORRECTIVE ACTION S Effects Purchasable results cannot be purchased if key card reader is not detected Check USB cable between key card reader and instrument reattach if necessary Install new key card reader 7 36 500005363 02 8 Limited Warranty This warranty gives you specific legal rights Additionally you may have other rights that vary from region to region The BD Viper LT instrument is warranted to the original purchaser to be free from defects in mate rials and workmanship for a period of one year following installation subject to the terms and con ditions of this warranty BD s sole responsibility under this warranty shall be to repair or replace at its discretion any instrument or its components except for expendable supplies such as printer cartridges paper or filters which under normal operating conditions prove to be defective within one year of delivery During such period BD will ship a replacement instrument or components at no additional cost to the user which in BD s sole judgment are found defective provided that the instrument has been operated in accordance with this BD Viper LT System User s Manual and has not been subjected to misuse and abuse With respect to any such replacement BD reserves the right to supply new or remanufactured components at its discretion All replacements will meet new part specifications and shall be war ranted as above for the remainder of the one
109. e Copy Rack and Print Results selection displays See Figure 2 4 To access the LIS Setup Tab From the Main display tap the configuration maintenance button ls Setup Tap the LIS Setup tab LIS Setup Fields LIS Parameters Window LIS Enabled Checkbox To enable LIS communications tap the checkbox so that a check appears in it To disable LIS communications default setting tap the checkbox so that the check disappears When enabled the parameters discussed below become active not grayed out Unsolicited Mode Checkbox Tap the checkbox so that a check appears in it to enable Unsolicited Mode In Unsolicited Mode the instrument uploads results to the LIS automatically when they are available default setting In Solicited Mode checkbox unchecked results are uploaded by the BD Viper LT instrument ONLY when requested by the LIS Packed Frames Checkbox Tap the checkbox so that a check appears in it to enable Packed Frames With Packed Frames the instrument uploads information in multiple records per frame default setting To disable Packed Frames tap the checkbox so that the check disappears When dis abled the instrument uploads one record per frame 2 12 500005363 02 2 Installation Baud Rate Tap the field to drop down a list of supported baud rates Then tap the desired baud rate to select it You can select from 300 600 1200 1800 2000 2400 3600 4800 7200 9600 default
110. e are no discrete fields on the Run Status Display There are 3 main areas of the display top of the display shows various timers progress bars and status messages relating to run operations 0 Consumable Check Reservoir Level Check in Progress Fe Dissolve Timer etc e Inthe Extraction Status window the rack number and rack barcode for the run are shown at the top center while this window is active At the top left messages related to sample preparation and extraction appear e g Rehydrating Controls Puncturing Extraction Tubes Lysis Sample Binding Wash Elution Mixing Samples Priming etc As extraction steps progress the specimen tubes on the display fill in to indicate progress of the extraction operation see Figure 5 17 Inthe Plate Status window at the bottom of the display timers progress bars and status messages relating to the priming amplification plates and readers appear e g Protocol Loaded Heat Spike Complete Transferring Samples to Reader Cleanup etc The rack number and rack barcode for the run is shown at the top of the plate that is being processed A timer for Time Remaining or the current status appears above each stage priming amplification reading Not all runs show all the possible steps depending on the mode Walkaway or High Throughput and assay type As plate operations progress the plate wells fill in as liquids are transferred and the plate outli
111. e loaded before the run starts walkaway mode Bottle connected to the instrument that stores waste liquid produced waste Boila during BD Viper LT runs Bin located on the right side of the instrument interior where waste tips are waste tip bin ejected 500005363 02 12 3 BD Viper LT System User s Manual 12 4 500005363 02 13 Cleaning Reference Frequency Location Cleaning Agent Procedure Specimen Rack Extraction Tube Rack Submerge in 1 v v sodium hypochlorite solution End of Run for 2 3 min Rinse thoroughly with tap water Allow Prime Plate Carrier to air dry Amp Plate Carrier 500005363 02 13 1 BD Viper LT System User s Manual Frequency Location Follow End of Run Activities Cleaning Agent Procedure Follow Post Run Cleaning procedure Touchoff Bar Wipe with 1 v v sodium hypochlorite rinse thoroughly with tap water and allow to dry Waste Liquid Bottle If the waste bottle is 1 2 full pour 400 mL undiluted bleach directly into the waste bottle Discard waste per procedure Wipe waste bottle exterior with 1 v v sodium hypochlorite followed by a wipe with tap water If the waste bottle is less than half full proceed with other cleaning procedures Optional Lighted Login Station Pre warm heater Handheld Barcode Scanner Remove and submerge Lighted Login station block in 1 v v sodium hypochlorite rinse
112. eared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument was unable to detect that the extraction tray moved to its destination within the time limit CORRECTIVE ACTION S Effect During instrument initialization a system alert is generated and the instrument initialization continues The robot portion of a run in progress is aborted However run does not have aborted status since specimen processing did not begin due to the error The reader portion of the run in progress continues Future runs are prohibited Error may be corrected by running Magnet QC Configuration Maintenance gt Tools gt QC Func tions gt Magnet QC If this does not correct the problem cycle instrument power If error persists contact your local BD representative EC 13002 Puncture tool dropped ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The puncture tool fell off while puncturing the reagent troughs CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted The reader portion of the run in progress continues Robot End of Run activities are not performed Future runs are permitted NOTE You must repeat the run if any portion was aborted If error recurs frequently contact your local BD representative 7 30 500005363 02
113. en a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The reader reported a configuration error and is unable to pass optical calibration CORRECTIVE ACTION S Effect Future runs are prohibited Service is required Contact your local BD representative 7 12 500005363 02 7 Troubleshooting EC 4008 Reader incorrect disposable type error ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The reader lid has been lowered to an unexpected height indicating an incorrect amplification plate type for the run CORRECTIVE ACTION S Effect The robot portion of a run in progress continues The reader portion of the run in progress is aborted Future runs are permitted NOTE You must repeat the run if any portion was aborted Make sure you use the amplification plate adapter If problem persists contact your local BD representative EC 4009 Reader thermal block performance error ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S Performance test reported thermal block degradation to unsatisfactory levels CORRECTIVE ACTION S Effect Future runs are not prohibited To correct the
114. eported in the Tube Result Report By default both assay results are reported 14 Tap the Save button to save the specimen The last saved tube location is shown below the test type in the Last Tube field 15 Place the tube in the assigned location in the specimen rack If you are using the optional Lighted Login Station the assigned location is lit with a blue LED 16 To remove one or more specimens Individual specimens can be deleted by tapping the assigned position on the screen If the second QC pair has been logged in it must be removed by tapping the remove QC pair button before you can delete logged in specimens 77 Only the last logged in individual specimen be removed Tap the delete button in the Specimen Login window The word Deleted then appears below the Last Tube field If multiple specimens must be deleted first delete the current last position then delete the new last position until all the desired specimens have been deleted To remove all logged in specimens tap the delete all logged tubes button below to the left of the assay field If there are multiple compatible assays on the same rack tapping the button removes only the last assay type logged in 500005363 02 4 7 BD Viper LT System User s Manual 17 18 The lot numbers for QC lots assay lots extraction tubes and reagent trough lots are shown in the Lot Numbers window at the bottom of the di
115. er QC 1 From the Main Status display tap the configuration maintenance button Tap the Tools tab From the Tools menu tap the QC button QC From the QC menu tap the Pre warm Heater QC menu selection If you want to verify heater temperatures manually insert the thermal tool adapters into Pre warm tube locations D1 and D2 Plug the thermocouple probe into the digital thermometer Insert the thermocouple probe into the thermal tool adapter in tube location D1 Turn the thermometer on Wait until Step 10 to check temperatures 6 Tapthe start button to initiate the QC function 7 In the confirmation window tap the Yes button to proceed or tap the No button to cancel the function If you select No you are returned to the QC menu 8 The Power and USB indicators are lit during the QC and the Protocol in progress and Protocol complete indicators flash 9 To abort the QC function while it is in progress tap the abort button In the confirmation win dow tap the Yes button to abort the function or tap the No button to proceed with the QC function 500005363 02 6 39 BD Viper LT System User s Manual 10 When the message that the heat spike has completed appears tap the OK button to begin the cooldown operation if you do not wish to perform manual temperature verification If you want to perform optional manual temperature verification see below Manual
116. ers see Figure 4 6 4 14 500005363 02 4 Operation Align stripe with top of bin Press liner down into bottom corners Figure 4 6 Inserting Waste Bin Liner 3 Check the waste bottle If the level is at or above the sensor follow the End of Day cleanup procedure for waste liquid Section 4 9 3 After emptying add the contents of a neutralization pouch to the container 4 Change gloves 5 When instrument is first powered on fill all tip stations with full pipette tip boxes Subsequently you only have to replace empty tip boxes partially filled boxes are tracked by the instrument Pipette tip stations are located at the left rear of the instrument deck 3 stations and at the front of the instrument deck just left of center 2 tip stations 500005363 02 4 15 BD Viper LT System User s Manual WARNING THE EXTRACTION REAGENT TROUGH CONTAINS CORROSIVE SUBSTANCES BE SURE TO STORE TROUGHS UPRIGHT AT ALL TIMES USE OF PERSONAL PROTECTION EQUIPMENT SUCH AS NITRILE GLOVES EYE PROTECTION AND LAB COATS IS STRONGLY RECOMMENDED WHEN HANDLING THESE REAGENTS DO NOT PUNCTURE REAGENT TROUGHS OR REMOVE FOIL COVERS IF ANY LEAKAGE IS OBSERVED IN REAGENT TROUGH PACKAGING OR WITHIN THE BAGS DO NOT REMOVE THE TROUGH FROM THE BAG DISCARD THE BAG AND ALL CON TENTS IN ACCORDANCE WITH ALL FEDERAL STATE REGIONAL AND INSTITUTIONAL GUIDE LINES SOLUTIONS CAN HAVE A STRONG CAUSTIC EFFECT INCLUD
117. ert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S All wells on a plate set have experienced liquid level errors CORRECTIVE ACTION S Effect The run is aborted Future runs are permitted NOTE You must repeat the run if any portion was aborted EC 1009 Unable to empty reagent reservoirs ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S At least one of the reagent reservoirs could not be emptied 500005363 02 T 5 BD Viper Instrument User s Manual CORRECTIVE ACTION S Effect All portions of the run continue Future runs are permitted Run the Disposal Protocol Configuration Maintenance Tools Manage Consumables Empty Reagent Troughs to empty reagent reservoirs then replace the trough If any reagent remains in the trough after the Empty Reagent Troughs protocol carefully remove the reagent trough and dispose of it as recommended in the Reagent Trough Cleanup instructions Section 4 9 5 3 EC 1010 Reservoir s not within specified limits ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S At least one of the reservoirs in the trough was not within the volume limits needed to start a run CORRECTIVE ACTION S Effect The robot po
118. es to com plete See Figure 3 2 When power is on one or more blue LEDs below the door handle are illuminated The LEDs track the movement of the robot gantry When the robot gantry is at rest a single LED slowly flashes at the right of the LED strip Just below the main power switch is main power input connector Figure 3 2 Main Power Switch left side of instrument 500005363 02 3 3 BD Viper LT System User s Manual 3 3 Door The door is locked and unlocked by the instrument software An electromagnetic latch keeps the door locked whenever the robot gantry may move See Figure 3 1 for door location To open the door check the display to see if the door is unlocked If it is grasp the door handle and pull the door toward you a little Then raise the door until it catches in its resting track To close the door grasp the door handle and pull the door toward you a little Then lower the door all the way until it is closed WARNING THE ROBOT GANTRY MOVES WITH CONSIDER ABLE VELOCITY AND FORCE NEVER ATTEMPT TO DEFEAT OR OVERRIDE THE DOOR INTERLOCK SWITCH SERIOUS USER INJURY CAN RESULT DO NOT ATTEMPT TO FORCE THE DOOR OPEN WHEN IT IS LATCHED IF THE DOOR MECHANISM CABLE FAILS WHILE THE DOOR IS OPEN AND IN THE RESTING TRACK POSITION THE DOOR WILL BE HEAVIER THAN YOU EXPECT IF THIS OCCURS BE SURE TO USE BOTH HANDS WHILE OPENING AND CLOSING THE DOOR IF THE DOOR MECHANISM CABLE FAILS WHILE T
119. esponding displays Plate Layout and Extraction Lot Login to update lot numbers if necessary To access the display tap the image of the disposable whose lot you want to update Note that changing lot numbers may create a condition where additional QC tubes have to be logged in which would require returning to the Tube Login display to compete before the run could be initiated 500005363 02 5 33 BD Viper LT System User s Manual Click Start to begin testing specimen rack 12 barcode m mE Walkaway LEAL LEO m ni o m a Figure 5 15 Start Run Display Confirmation Tapping a plate graphic at the bottom of the display takes you to the Plate Layout display 5 34 500005363 02 5 Reference Figure 5 16 Start Run Display Rack Selection 500005363 02 5 35 BD Viper LT System User s Manual 5 6 Run Status Display The run status button is enabled when a run is in progress The display shows the steps that are occurring any progress bars timers etc The Run Status display also provides a button to abort either the robot or the reader portion of the run See Figure 5 17 To Access Run Status From the Main Status display tap the run status button Run Status Display Icons and Buttons abort robot button appears only abort reader appears only when during robot operations reader is active Run Status Fields Ther
120. f any of the XYZ values is more than 0 20 mm from the internal alignment values the channel is considered out of alignment Weekly Maintenance includes the weekly cleaning procedure If Weekly Maintenance is not performed once in a 7 day period the instrument disables the start run function Before beginning the instrument Weekly Maintenance function first remove the pipette tip rack and reagent trough rack and clean them as described below To Remove Clean the Pipette Tip Rack and Reagent Trough Rack The Weekly Maintenance function takes about 6 minutes to complete The cleaning procedure takes about 1 2 hour to complete To Access Weekly Maintenance From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab QC From the Tools menu tap the QC button Maintenance Weekly From the QC menu tap the Maintenance Weekly menu selection Weekly Maintenance Buttons start button abort button Remove Clean the Pipette Tip Rack and Reagent Trough Rack 1 Perform the Post Run cleaning procedure Section 4 9 2 Remove and discard all empty pipette tip trays and reagent trough from the Viper LT deck 2 Remove the plate seal tools and set them aside 3 Remove the pipette tip rack by loosening the 2 disconnects see Figure 6 3 and 6 4 500005363 02 6 9 BD Viper LT System User s Manual Plate Seal Station for reference Plate Seal Station for refe
121. g Symbol for electrical hazard documentation specifically the user s manual for instructions Figure 1 4 Symbols Used on the BD Viper LT Instrument 1 8 500005363 02 1 Introduction 1 6 4 Notes Cautions and Warnings Throughout this manual important information is presented in boxes offset from the regular text and is labeled as a NOTE CAUTION or WARNING These messages are formatted as shown below and bear the following significance NOTE Important information about instrument use worthy of special attention is presented as a NOTE CAUTION Information on an activity which potentially could cause damage to the instrument is presented as a CAUTION WARNING INFORMATION ON AN ACTIVITY WHICH POTEN TIALLY COULD CAUSE INJURY TO THE USER IS PRESENTED AS A WARNING 500005363 02 1 9 BD Viper LT System User s Manual 1 7 Summary of Cautions and Warnings PROTECTION PROVIDED BY THIS EQUIPMENT MAY BE IMPAIRED IF THE EQUIPMENT IS USED IN A MANNER NOT CONSISTENT WITH THE INSTRUCTIONS IN THIS MANUAL ALL SYSTEM USERS MUST BECOME THOROUGHLY FAMILIAR WITH ALL CONTROLS AND INDICATORS BEFORE ATTEMPTING TO OPERATE THE SYSTEM THE ROBOT GANTRY MOVES WITH CONSIDERABLE VELOCITY AND FORCE NEVER ATTEMPT TO DEFEAT OR OVERRIDE THE DOOR INTERLOCK SWITCH SERIOUS USER INJURY CAN RESULT DO NOT ATTEMPT TO FORCE THE DOOR OPEN WHEN IT IS LATCHED IF THE DOOR MECHANISM CABLE FAILS WHILE THE DOOR IS OPEN AND IN
122. ge consumables Section 6 2 4 3 Register a barcode scanner Section 6 2 4 4 Move robot gantry Section 6 2 4 5 Calibrate touchscreen Section 6 2 4 6 Refer to the sections noted above for specific information on those functions Refer to the material below for general information on the Tools tab The Tools functions other than Register barcode scanner and Calibrate touchscreen are accessible only when the instrument is idle See Figure 5 24 To Access the Tools tab From the Main Status display tap the configuration maintenance button Tap the Tools tab 5 54 500005363 02 5 Reference Tools Buttons save data to USB button update software button QC functions button manage consumables button register barcode scanner button move robot reader button calibrate touchscreen button 3 58 Ww 500005363 02 5 55 BD Viper LT System User s Manual Figure 5 24 Tools Tab 5 56 500005363 02 5 Reference 5 9 Instrument Alerts Display The Instrument Alerts display provides a list of all persistent alerts that are currently active in the instru ment The list is not dynamic the alert list is compiled when you access the display and is current as of that moment For more information on types of alerts see Section 4 8 For a list of all instrument alerts possible causes and corrective actions see Section 7 3 See Figure 5 25 T
123. he start button to initiate the QC function 4 In the confirmation window tap the Yes button to proceed or tap the No button to cancel the function If you select No you are returned to the QC menu 5 To abort the QC function while it is in progress tap the abort button In the confirmation win dow tap the Yes button to abort the function or tap the No button to proceed with the QC function 6 The QC function consecutively lights all the station LEDs Verify that all LED indicators illuminate Make a notation and contact your local BD representa tive if any of the LEDs does not light 500005363 02 6 7 BD Viper LT System User s Manual Figure 6 2 Lighted Login Station all LED indicators illuminated 8 When the function is complete the status is displayed at the right of the menu selection This status indicates only that the instrument succeeded or did not succeed in completing the func tion not that the LEDs are all operational You must visually confirm the operation of the LEDs during the QC function H completed indicator not completed aborted indicator 6 8 500005363 02 6 Maintenance 6 2 2 Weekly Maintenance The Weekly Maintenance function checks the XYZ alignment of each of the 4 pipettor channels The waste block is used as a known position and the channel ends touch the waste block to compare that value against internally stored alignment values I
124. he priming stage to the right of the reader The priming plate is keyed to fit on the stage in one orientation only Make sure no foreign objects e g specimen caps are inside the instrument anywhere Close the instrument door WARNING THE ROBOT GANTRY MOVES WITH CONSIDERABLE VELOCITY AND FORCE NEVER ATTEMPT TO DEFEAT OR OVERRIDE THE DOOR INTERLOCK SWITCH SERIOUS USER INJURY CAN RESULT BE CAREFUL OF PINCHING FINGERS WHEN CLOSING THE DOOR BE SURE THE PRIMING HEATER IS FREE OF DEBRIS AND THE PRIMING MICROWELLS ARE SEATED PROPERLY PRIOR TO STARTING THE RUN 4 18 500005363 02 4 Operation 4 6 Rack and Run Statuses 4 6 1 Rack Statuses Racks can have the following statuses chronological order Can Copy Conditions Delete Print Rack was defined and the Rack Login display was exited Ongoing Has rack barcode P Tube Layout Has rack number Has defined QC pair Pre Warmed Run has not begun but pre warm step completed P Tube Layout Run has started but consumable checks have not completed Consumable checks have completed run is sample Prep starting extraction Plates have been sealed and are reading Reading depending on tube statuses Complete Run completed successfully P Tube Result LIS Pending Run completed successfully results have not yet C Complete been uploaded to LIS P Tube Result For the statuses below a run
125. he screen 4 A message appears when the barcode scanner is successfully registered gt Barcode Scanner Test LDP To register your barcode scanner click the Scan button then scan the barcode ma 123456789012 Figure 6 15 Register Barcode Scanner Window 500005363 02 6 31 BD Viper LT System User s Manual 6 2 4 5 Move Robot Reader Function The Move Robot Reader function enables you to move the robot gantry from its home position on the right side of the instrument interior to the left This enables you to access the waste solid disposal bin to replace the bag and clean the station Another button on the display enables you to move the reader enclosure so that you can access the amplification stage heater You can also verify the operation of the door lock mechanism See Figure 6 16 To Access the Move Robot Reader Function From the Main Status display tap the Configuration Maintenance button Tools Tap the Tools tab t From the Tools menu tap the move robot reader button Move Robot Reader Buttons lock door button unlock door button E close reader button open reader button move robot gantry button To Move the Robot Gantry 1 Access the Move Robot Reader function as described above Close the instrument door Tap the move robot gantry button on the left side of the deck graphic to move the rob
126. hen you check the External control checkbox the Tube Login window fields change see Figure 5 6 The following fields appear Manufacturer Id Enter up to 20 characters to identify the manufacturer of the control This information is optional Lot Number Enter up to 20 characters to identify the lot number of the control This information is optional You cannot use the following characters 2 154 Positive radio button Select to designate the control as the positive control You must designate an External control as either Positive or Negative Negative radio button Select to designate the control as the negative control You must designate an Exter nal control as either Positive or Negative 500005363 02 5 15 BD Viper LT System User s Manual NOTES Optional SDA QC tubes Rehydrate checkbox checked and External controls are not indicated as Quality Control tubes on any report or display and are tested and reported as ordinary specimens Rehydration tubes are indicated with a positive or negative rehydra tion icon on the Tubes Result report f you rehydrate a tube marked for rehydration it causes a liquid level error during processing f you erroneously mark a normal specimen tube for rehydration it fails rehydration fluid checks and causes the run to abort A maximum of 10 QC tubes required plus optional can be run on a specimen rack 2 2 Specimen Tube Login D01 CN
127. hlorite solution and wipe the outside surface of the waste bottle Rinse with a lab wipe dampened with tap water Before placing the bottle back on the instrument allow it to dry by placing it upside down on absorbent material Replace the bottle with a clean dry liquid waste bottle Add a Viper Neutralization Pouch to the bottle and replace the lid Reattach the quick release valve to the waste tubing and reposition the waste bottle under the Viper LT instrument Reconnect the sensor cable using the alignment markings UM i Sensor Cable unscrew here to disconnect Sensor Location Figure 4 11 Waste Bottle Sensor Location 4 29 BD Viper LT System User s Manual O Dampen a lab wipe with 3 hydrogen peroxide to clean the items below do not use hydrogen peroxide from a bottle that has been open longer than 8 days Each time that a change of lab wipe is indicated below dampen a new lab wipe with 396 hydrogen peroxide and clean the specified area CAUTION Do NOT use bleach or sodium hypochlorite solution on any of the areas listed below unless specified Wipe the door handle e Wipe the monitor Change lab wipe and wipe the reagent trough station and trough lockdowns Change lab wipe and wipe the entire surface of the extraction station e Move to the left side of the deck change lab wipe and wipe the priming heater and surrounding areas Change lab wipe and wipe the plate se
128. ics enables you to export specimen data for completed runs to a CSV Comma Separated Values file on a USB flash drive The data is grouped by runs racks with speci mens reported in rows and data for those specimens within columns see below for data reported QC tubes External Controls and Rehydration tubes are not exported Only racks with a status of com pleted are exported aborted racks and pending untested racks are not exported A file with the name yyyy mm dd hhMMss csv is exported onto the USB flash drive where yyyy is the year mm is the numeric month and dd is the day of the export operation HH is the hours 24 hour for mat MM is minutes and ss is the seconds when the export was performed The CSV file contains the following data e Rack Rack Barcode Time Run Ended Reagent Trough Lot Pos ition e Test Group e Extraction Tube Lot e Accession Test Code e Well Lot Result Positive Negative EC Fail Extraction Error Error Liquid Level Error Suppressed e RFU Patient ID e Sex Age e Hosp ital Service Hosp ital Client To Export Tube Demographics From the Main Status display tap the reports menu button Export Tube Demographics Highlight Export Tube Demographics Tube Export Parameters window appears Figure 5 23 5 52 500005363 02 5 Reference Defaults to blank Enter the Start Date mm dd yyyy by
129. imen Tube self clearing aborts the robot run doesn t perform Robot end of run activities reader portion of a run continues EC 9008 Tip stuck in specimen tube ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S A tip got stuck in a specimen tube CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted Robot End of Run activities are not performed The reader portion of the run in progress continues NOTE You must repeat the run if any portion was aborted Examine the specimen tubes and remove any tip s that may have become stuck Clean any areas of the instrument deck if required If error recurs contact your local BD representative EC 9009 Tip acquisition failure during tip management ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument failed to acquire tips where expected during consumable check or tip consolida tion CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted Tip consolidation operation is aborted Disposal Protocol and Volume QC functions are aborted if in progress The reader portion of the run in progress continues Future runs are prohibited NOTE You must repeat the run if a
130. instructions furnished separately for information on checking replacing paper for your printer 6 2 1 2 Daily Maintenance The Daily Maintenance function is designed to verify cLLD capacitive liquid level detection and pipet tor pressure This enables the instrument to keep track of the status of the robot pipettor and verify that essential functions are operating correctly The cLLD test is a method of liquid level detection During instrument operation the conductive pipette tip is given an electrical charge When it touches something liquid or metal the charge is dissipated and conductance is used to detect the height of an item In the maintenance function the metal chan nel end is charged and then it touches the waste block to ensure that the cLLD is working For the pipettor pressure check each channel is tested using positive and negative pipettor pressure to insure that there are no leaks The pressure check uses the 4 airtight metal tips in the waste block see Figure 6 1 The Daily Maintenance function takes about 6 minutes to complete Waste Tip Bin gt Jy a Metal Pipette Tips 65 Extraction Rack gt Figure 6 1 Metal Tips Used in Maintenance Functions 500005363 02 6 3 BD Viper LT System User s Manual To Access Daily Maintenance From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab From the Tools
131. intenance Tools QC Functions Robot QC If this does not correct the problem cycle instrument power If error persists contact your local BD representative 500005363 02 7 31 BD Viper Instrument User s Manual EC 13005 Puncture tool general failure ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The puncture tool pickup operation reported an error CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted The reader portion of the run in progress continues NOTE You must repeat the run if any portion was aborted Error may be corrected by running Robot QC Configuration Maintenance Tools QC Functions Robot QC If error persists contact your local BD representative EC 14001 Barcode scanner not connected ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S A communication error with an onboard barcode scanner was detected The specific barcode scanner is identified in the message text CORRECTIVE ACTION S No effect on any portion of a run in progress When run completes cycle instrument power or Pre warm heater power specified in message text
132. ion 5 7 4 Export Tube Demographics Section 5 7 5 Configuration Maintenance Section 5 8 Instrument Section 2 4 1 System Section 2 4 2 Tools Section 5 8 1 Save Data to USB Section 6 2 4 1 Install Software Section 6 2 4 2 QC Functions Section 6 2 Manage Consumables Section 6 2 4 3 Register Barcode Scanner Section 6 2 4 4 Move Robot Reader Function Section 6 2 4 5 Calibrate Touchscreen Section 6 2 4 6 LIS Setup Section 2 4 4 Instrument Alerts Section 5 9 5 2 500005363 02 5 Reference 5 3 Main Status Display The Main Status display Figure 5 1 is the default display that appears immediately after instrument bootup This display presents general instrument status information and button definitions that allow you to perform activities The following instrument status information is presented Instrument name Software version Instrument number LIS if enabled and Door status indicators Date and Time Pre warm heater status The button assignments at the right of the display show operations that can be performed Functions that cannot be performed are grayed out To access a display or perform a function tap the associated button on the screen Main Status Display Icons and Buttons instrument number rack operations button MM DD YYYY Day date and time start run button HH MM AM run status button reports button configuration maintenance button instrument
133. ists contact your local BD representative EC 10008 Robot finalize error ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The robot failed when attempting to finalize an operation CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted The reader portion of the run in progress continues Future runs are permitted 7 24 500005363 02 7 Troubleshooting NOTE You must repeat the run if any portion was aborted No other corrective action is required If error recurs contact your local BD representative EC 10009 Labware detect error ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The robot failed to detect required labware deck components such as the prime plate tip rack extraction rack etc CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted Robot End of Run activities are not performed The reader portion of the run in progress continues Disposal Protocol and Volume QC functions are aborted if in progress Future runs are permitted NOTE You must repeat the run if any portion was aborted No other corrective action is required If error recurs contact your local BD representative EC 10010 Robot position error ALERT TYPE
134. ital thermometer for tube location 06 q Within 30 sec move the thermocouple probe from tube location D6 to tube location D1 r Move the thermal tool adapter from tube location D6 to tube location D2 S tap the OK button on the screen to begin the cooldown operation t After cooldown has completed turn off digital thermometer remove thermocouple probe and remove the two thermal tool adapters Verify that all manual temperature readings at 119 0 2 0 C Continue with Step 11 above 500005363 02 6 41 BD Viper LT System User s Manual 6 2 4 9 Prime Heater QC The Prime Heater QC function tests the components including both the primary and QC temperature sensors of the priming heater It can be used to clear some priming heater errors Prime Heater QC takes just under 15 minutes to complete To Access Prime Heater QC From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab C From the Tools menu tap the QC button ac Prime Heater From the QC menu tap the Prime Heater QC menu selection Prime Heater QC Buttons start button abort button To perform Prime Heater QC 1 Access the Prime Heater QC function as described above 2 Tap the start button to initiate the QC function 3 1 the confirmation window tap the Yes button to proceed or tap the No button to cancel the function If you select No you
135. language or computer language in any form or by any means electronic mechanical magnetic optical chemical manual or otherwise without the prior written permission of BD 7 Loveton Circle Sparks Maryland 21152 United States of America ii 500005363 02 Preface Contents 1 Introduction 1 1 1 2 1 3 1 4 1 5 1 6 1 7 lise 1 1 eL riale 1 1 Instrument OVerviGW isset ci aces t rd 1 2 1 3 1 BD Viper Instrument 2 1 2 1232 System Peripherals ttt cta ed aa 1 5 1 3 2 1 BD Pre warm Heater 1 5 1 3 2 2 Lighted Login Rack 1 5 1 9 2 9 Specimen Rack nii ee tet bat deese anb d de 1 5 1 3 2 4 Barcode Scale uio 1 5 1 3 3 Instrument Software tent aai ni Gen 1 5 IER TEES StruCture cir riali iii cei ire 1 7 Use of this Martal itr a 1 7 NEFS PX Nba OVE 1 7 1 6 1 1 7 1 6 2 Displays Sample Data and Product 1 8 1 6 8 Symbols Used on the Equipment 1 8 1 6 4 Notes Cautions and
136. lay Figure 5 13 Racks that have already been pre warmed show a pre warm icon at the right of the list Tap the desired rack to select it then tap the pre warm button to initiate the pre warm protocol ul 4 12 500005363 02 4 Operation The progress bar at the bottom of the Pre warm heater window Figure 4 5 shows the prog ress of the pre warm protocol The timer in the progress bar counts down the time remaining WARNING SPECIMEN RACKS SPECIMEN TUBES AND THE PRE WARM HEATER ARE HOT DURING PRE WARM PROTOCOLS AND UNTIL THE COOL DOWN OPER ATION COMPLETES ALWAYS ALLOW THE COOL DOWN OPERATION TO COMPLETE BEFORE HAN DLING SPECIMEN RACKS OR SPECIMEN TUBES OR THE PRE WARM HEATER ITSELF 6 Ifyou remove the rack from the Pre warm heater before the protocol timer has completed the protocol is immediately aborted The message Resetting hh mm ss appears in the Status Bar In some cases an aborted pre warmed rack may be rewarmed consult the assay specific package insert for additional information 7 When the pre warm protocol is complete the message Complete appears in the status bar Remove the specimen rack from the heater and place it in the specimen rack station on the instrument 8 As you are pre warming specimens you can set up the instrument for the run Pre warming protocols typically last approximately 40 60 minutes depending on the assays selected You canno
137. llation Card Status Window This function is not enabled for instruments distributed in the United States This window enables you to view the current status of the key card reader and any key card that is inserted in the reader The status is updated dynamically Assay Configuration Window This window enables you to view the currently installed assays and assay definition version and to select the assays you want to appear in the Test Type field during Rack Login Assay The assay column shows all existing assays defined in the instrument The list is read only it cannot be changed by the user Assays can only be added by a software update Version The current version of each assay definition is shown This information is read only Available checkbox The Available checkbox enables you to select which assays appear in the Test Type field on the Rack Login display If you do not want to use one or more assays you can remove them from the Avail able list To remove a test from the Available list tap the Available checkbox for that assay to clear the checkbox To add a test to the Available list tap the Available checkbox for that assay to fill the checkbox At least one assay must be kept in the Available listing 500005363 02 2 4 BD Viper LT System User s Manual 7 E Instrument System Tools LIS Setup Instrument DE Walkaway This function is not enabled for
138. lts selections but current default lot numbers are used not original ones Default extraction lot numbers are used not original ones Same or compatible assay can be selected QC tube locations but not QC kit numbers are copied to new rack e Rack number is automatically generated e Rack barcode number is copied to new rack e Testresults for the original tube rack are not copied to new rack Pre warm status of rack is copied to new rack e External controls are copied to new rack with ID and Lot information e Rehydration tubes are copied to new rack with lot information The maximum number of racks that can be copied is 29 See Figure 5 13 To Access the Copy Rack display From the Main Status display tap the rack operations button From the Rack Operations menu tap the copy rack button The Copy Rack display appears Copy Rack Icons and Buttons copy rack indicator button results not uploaded to LIS indicator 355 rack has been pre warmed x d indicator 500005363 02 b 27 BD Viper LT System User s Manual O 13 20742 10 1 03 1 00001 8 30 2011 10 57 45 Figure 5 13 Copy Rack Display Rack Selection 5 28 500005363 02 5 Reference Copy Rack Fields Specimen Rack Selection Window When the copy rack button is tapped the Copy Rack display Figure 5 13 appears This dis play shows all aborted completed and currently testing
139. lutions see Section 4 9 Cleanup for additional information If error recurs contact your local BD representative 7 20 500005363 02 7 Troubleshooting EC 9004 Tip acquisition failure 3x ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument after two retries couldn t pick up tips in a location where tips were expected The instrument could really be out of tips or there may be a failure with the hardware CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted Disposal Protocol and Volume QC functions are aborted if in progress Extraction tubes and reagent trough are not emptied The reader portion of the run in progress continues Future runs are prohibited NOTE You must repeat the run if any portion was aborted Fill pipette tip stations with full boxes Run the Reset Tip Counters to Full function Configuration Maintenance Tools Manage Con sumables Run Consumables Management Disposal Protocols to dispose of hazardous extraction materials Configuration Maintenance Tools Manage Consumables Empty Reagent Troughs Empty Extraction Tubes Be sure to fill all pipette tip stations before beginning a run If error persists contact your local BD representative EC 9005 Tip ejection into solid w
140. ly those that involve timers and countdowns that await user input NOTE You must repeat the run if any portion was aborted 500005363 02 7 3 BD Viper Instrument User s Manual EC 1002 Reboot during run ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S A reboot occurred while the instrument was executing a run CORRECTIVE ACTION S Message is informational and appears after the instrument has rebooted Effect The robot and reader portions of the run in progress are aborted when the reboot occurs Future runs are permitted Identify the cause of the reboot in the Initialization Message title bar Contact your local BD repre sentative NOTE You must repeat the run if any portion was aborted EC 1003 Failed to rehydrate a Control tube ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S During the pre or post hydration liquid level check of any QC tube or specimen tube marked for rehydration insufficient liquid is detected in the tube for the defined operation or fluid is found when there should not be any Can also occur if instrument fails to get reagent needed to rehydrate a QC tube or specimen tube marked for rehydration or when there is insufficient fluid in a reagent trough CORRECTIVE ACTION S Me
141. m heater 1 6 Conventions 1 6 1 Keys Screen buttons and icons are always identified by lowercase letters in quotes unless there is actual text in the button which is shown verbatim and the words button or icon e g start run button and Yes button Field and display names are capitalized and use normal text e g Rack Number Extraction Lot Login display or the actual case of the field or the display Dynamic messages are shown in a monospaced typeface e g Reservoir Level Check in Progress 500005363 02 1 7 BD Viper LT System User s Manual 1 6 2 Displays Sample Data and Product Features Displays shown in this manual are configured with examples of assays features and data that may not be available in all regions The depiction of a specific assay or feature on a sample display is not an indication that the assay feature is available for sale or use in a given region In addition some product features are used only with certain assays NOTE Assay availability and features on the BD Viper LT vary from region to region contact your local BD representa tive for information on specific assay and feature avail ability Version numbers shown on sample displays are indicative of placement only and are not intended to represent the currently available version 1 6 3 Symbols Used on the Equipment The following symbols appear on the BD Viper LT instrument Symbol for refer to accompanyin
142. material THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES WHETHER EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE IN NO EVENT WILL BD BE LIABLE FOR INDIRECT INCIDENTAL SPECIAL OR CONSEQUENTIAL DAMAGES REGARDLESS OF WHETHER BD HAS BEEN ADVISED OF SUCH 8 2 500005363 02 9 Maintenance Log A full page Maintenance Log is provided in this Appendix for your convenience 500005363 02 9 1 BD Viper LT Maintenance Log Month Year WEEKLY MONTHLY IAS NEEDED Printer Daily Paper Maint Replace Plate Seal Suction Cups Clean Replace Air Filter Monitor for DNA As Needed Contani enter number Pre warm Station LEDS Optional Lighted Login Rack LEDS Weekly Maint Cleaning End of Day Cleanup N Instrument Check Printer Paper Daily Maintenance Pre Warm Station LEDs Opt Lighted Login Rack LEDs End of Day Cleanup WEEKLY Weekly Maintenance Cleaning MONTHLY Replace Plate Seal Suction Cups Clean Replace Air Filter Monitor for DNA Contam AS NEEDED 1 Manage Consumables 2 Register Barcode Scanner 3 Calibrate Touchscreen 4 Magnet QC 5 Pre warm Heater QC 6 Prime Heater QC 9 Volume QC 10 Clean Barcode Scanner Window 10 Ordering Information Below is a list of replacement parts accessories and disposables for use
143. menu tap the QC button Maintenance Daily From the QC menu tap the Maintenance Daily menu selection Daily Maintenance Buttons start button abort button To perform Daily Maintenance Access the Daily Maintenance function as described above Verify that the 4 metal tips are in their stations Tap the start button to initiate the QC function kb N In the confirmation window tap the Yes button to proceed or tap the No button to cancel the function If you select No you are returned to the QC menu 5 When the second confirmation window appears confirm that the instrument door is closed Then tap the Yes button to proceed Tap the No button to cancel the function If you select No the function is aborted 6 To abort the QC function while it is in progress tap the abort button In the confirmation win dow tap the Yes button to abort the function or tap the No button to proceed with the QC function 7 When the function is complete the status is displayed at the right of the menu selection H pass indicator fail aborted indicator 8 f a pass result is reported the maintenance function completed successfully If fail is reported contact your local BD representative for assistance 6 4 500005363 02 6 Maintenance 6 2 1 3 Check Pre warm Heater LEDs The Pre Warm Station LED QC function lights all the LEDs of the Pre warm heater
144. merge a priming microwell plate Submerge the priming plate in the cleaning solution for 2 3 minutes Rinse the plate with tap water and allow to air dry Dampena lab wipe with 3 v v hydrogen peroxide wipe the priming stage and allow to sit for 2 3 minutes Dampen a lab wipe with tap water and wipe the surface of the heater plate Allow to air dry e Perform Environmental Monitoring Section 6 2 3 1 of the priming stage Repeat cleaning and monitoring procedures until negative results are obtained 4 32 500005363 02 4 Operation 4 9 5 5 Cleaning Amplification Stage If fluid is on the amplification heater stage follow this procedure e Remove the amplification plate and adapter from the amplification heater Seal the plate remove and place microwells in a resealable bag Dispose in biohazard trash Prepare fresh cleaning solution 196 v v sodium hypochlorite solution in a container large enough to submerge an amplification microwell plate Submerge the amplification plate in the cleaning solution for 2 3 minutes e Rinse the plate with tap water Shake out excess water from the wells and allow to air dry Dampen lab wipe with 3 v v hydrogen peroxide wipe the amplification stage and drip tray and allow to sit for 2 3 minutes Dampen a lab wipe with tap water and wipe the surface of the heater plate Allow to air dry Perform Environmental Monitoring Section 6 2 3 1 of the SDA
145. mometer that displays readings See Figures 3 11 3 12 When using the thermal tool be sure the tool is at room temperature before use Place the metallic end of the adapter into the Pre warm heater well Plug the temperature probe into the thermometer Avoid touching the metallic probe tip it will degrade the measurement accuracy Place the probe in well D1 all the way then initiate the QC procedure as described in Section 6 2 4 8 Do not begin to record read ings until the pop up message on the instrument monitor advises you that the heating portion of the QC is complete The thermal tool is powered by a single 9 VDC alkaline battery that does not need to be replaced dur ing the tool s service life 1 year After completing Temperature QC place all kit components back in the case provided with the kit LCD Display Temperature readings and messages are displayed on the unit s LCD display On Off Button Press this button to turn the tool on and off Immediately after power is applied the unit performs a self test Then the temperature measured by the probe is O displayed If the words LO and HIGH alternate on the LCD this indicates that the temperature probe is not attached correctly to the handheld unit Hold Temperature Button Press this button to freeze hold the temperature reading on the LCD Press the button again to return to the current temperature measurement When the function is active the word
146. n Display 4 5 Figure 4 2 Specimen Login 4 6 Figure 4 3 Extraction Lot Login Display 4 9 Figure 4 4 Plate Layout Display 4 11 Figure 4 5 Pre warm Heater Window 4 13 Figure 4 6 Inserting Waste Bin 4 15 Figure 4 7 Extraction Trough 4 17 Figure 4 8 Instrument Layout 4 17 Figure 4 9 Touchoff 4 28 Figure 4 10 Sensor Cable 4 28 Figure 4 11 Waste Bottle Sensor 4 29 Figure 5 1 Main Status 5 4 Figure 5 2 Rack Operations Menu 5 8 Figure 5 3 Rack Login Display 5 12 Figure 5 4 Tube Login 5 14 Figure 5 5 Tube Login Window for Rehydrated Optional 5 14 Figure 5 6 Tube Login Window for External 5 16 Fig
147. n Rack Base USB port shown at left Figure 3 9 Lighted Login Rack Tube Alignment Block 3 10 500005363 02 3 Controls and Indicators 3 8 Monitor and Touchscreen The LCD monitor with touchscreen is mounted on the front left area of the instrument A touch sensi tive screen enables you to issue commands to and enter information into the instrument simply by tap ping buttons fields and the onscreen keyboard that appear on the screen see Section 3 11 The monitor is mounted on an articulating tilt and swivel arm that allows you to adjust the tilt for opti mum viewing To adjust the tilt or height grasp the monitor with both hands one on each side makes adjustment easier and position the monitor where desired If the touchscreen does not seem to register your taps accurately use the Calibrate Touchscreen func tion Section 6 2 4 6 to realign it In general BD recommends that you do not adjust the monitor s settings as improper settings can cause the display to change position or become unreadable However you can safely adjust the Con trast half dark half light circle icon Brightness sunburst icon and Volume speaker icon settings if needed Buttons are located along the top edge of the monitor To adjust settings press the MENU button far left then navigate to the desired setting with the or V key Then press the SELECT key to enable making adjustments to the desired setting Use the A
148. n if the door is unlocked Date and Time Date day of the week and time are located below the LIS and Door status indicators This is a read only field showing the current instrument date and time Main Status Display Buttons rack operations button Tap to access rack operations functions such as Rack Login Modify Rack Copy Rack etc Refer to Sections 5 4 1 5 4 4 for additional information start run button Tap to initiate a run Refer to Section 5 5 for additional information run status button Tap to view run status Refer to Section 5 6 for additional information reports button Tap to access the Reports menu Refer to Section 5 7 for additional information configuration maintenance button Tap to access configuration or maintenance functions Refer to Section 5 8 for additional infor mation instrument alerts button Tap to view instrument alerts Refer to Section 5 9 for additional information 500005363 02 5 5 BD Viper LT System User s Manual Pre warm Heater Window The Pre warm Heater window is located at the bottom of the Main Status display It presents infor mation about the status of the Pre warm heater and allows you to initiate pre warm protocols For additional information on the Pre warm heater refer to the separate operating instructions BD Pre warm Heater Instructions document number 8086781 Pre warm Heater Window Field Rack Information Rack information appears
149. ne fills in to indicate the overall progress of processing When the plate is being read the door is unlocked if you selected High Throughput mode to allow you to place the consumables for the next run on the instrument deck It is also unlocked when robot cleanup activities are complete 5 36 500005363 02 5 Reference Fe Dissolve Timer A Extraction Status Rack 3 Barcode 89742 00 0 4 e e e e e OTO 050 Plate Status i i Figure 5 17 Run Status Display Progress bars tubes wells and plates fill as the corresponding operation progresses 500005363 02 5 37 BD Viper LT System User s Manual Aborting a Run You can abort the robot portion of a run when robot operations are in progress or the reader por tion of a run when the readers are active To abort a run 1 Click the abort robot button or abort reader button depending on the portion of the run you want to abort 2 Awindow appears confirming that you want to abort the run 3 To abort the run click and slide the bar to the right and tap the Yes button 5 7 Reports The BD Viper LT instrument has 4 reports Tube Layout Report Section 5 7 1 Result Report Section 5 7 2 e Temperature History Report Section 5 7 3 e Search by Accession Number Section 5 7 4 report is display only does not print The Tube Layout Report can be printed from the Ra
150. new plate seal for the next run 4 22 500005363 02 4 Operation 4 8 Responding to Alarms and Errors As you perform activities at the BD Viper LT instrument and as testing progresses instrument alerts and errors may occur See Section 7 2 for the different types of alerts Different types of alerts and errors are flagged by one or more of the following E error codes popup messages audible tones and the instrument alert icon becoming active on the LCD monitor CAUTION When the instrument notifies you of alerts and errors you should immediately respond to the condition Unresolved persistent alerts are reported in the instrument alert list These errors can be reviewed by pressing the instrument alert button see below The BD Viper LT instrument supports use of the optional Remote Alarm unit The Remote Alarm is acti vated whenever a System Alert occurs when the Heat and Transfer Step message occurs and when the robot portion of the run is complete after clean up completes alarm sounds for 30 sec onds When these messages are acknowledged by tapping the OK button in the message the Remote Alarm is silenced All the E error codes are discussed in detail in Section 7 3 Error Message List The audible tones are discussed in Section 3 12 Audible Tones and Alarms 500005363 02 4 23 BD Viper LT System User s Manual 4 9 Cleanup Before begi Section 4 9
151. nformation Window Tools Tab refer to Section 6 2 3 1 e LIS Setup Tab Section 2 4 4 The Main Status display which is active immediately after instrument startup is shown in Figure 2 1 To access configuration and maintenance tools tap the configuration maintenance button shown below When you enter configuration mode the Instrument tab appears Most field values can be changed by tapping the arrows up down drop down arrows or checkboxes next to them 2 4 500005363 02 2 Installation BD Viper LT V2 30A US ay Ta 7 30 2013 Tuesday 4 26 PM Pre warm Heater Attention w BD Figure 2 1 Main Status Display When you tap the exit button if you made any changes to any fields you are asked if you want to save the changes Tap the Yes button to save the changes or tap the No button to exit the display without saving changes The screen returns to the Main Status display Z Any changes to configuration parameters take effect after you accept the change and forward not ret roactively 500005363 02 2 5 BD Viper LT System User s Manual 2 4 1 Instrument Tab The Instrument tab appears when you tap the configuration maintenance button It enables you to set several instrument related parameters such as instrument number assay configuration etc See Figure 2 2 To access the Instrument Tab From the Main display tap the
152. ng defined but untested racks You cannot exit the display if you have not entered the rack barcode 5 10 500005363 02 5 Reference If the instrument detects that a barcode entered is already in the database for an Ongoing rack a message advises you of this condition You can work around and correct the situation with the fol lowing steps e Verify that the barcode number you entered is correct and note the rack number Enter a dummy number for the rack barcode in order to save the rack definition note this number too e Go to the Modify Rack display and locate the rack with the duplicate barcode Change or delete the duplicate rack barcode so that you can continue with the one you are currently logging in don t try to change it to the dummy number you used a moment ago Recall the rack with the dummy barcode number and change it to the correct number Assay The default assay defined in Configuration Instrument Assay Configuration appears in the Assay field You can select another assay as follows tap the field to drop down the list of defined assays scroll to the desired assay by tapping the down up arrow in the list box scroll bar then tap the desired assay Multiple assays can be used on a single rack Only compatible assays can be logged in on the same rack Note that all specimens for a selected assay must be contiguous and that assay cannot be selected a second time on the same rack To selec
153. nimum Do NOT use bleach or sodium hypochlorite solution on any of the areas listed below unless specified See Section 4 9 3 End of Day Cleanup If the instrument loses power reboots observe the pipettor If there is a tip on the adapter closest to the front of the instrument in order to avoid damage to the pipettor make sure that the extraction reagent trough lockdowns in the open position see Figure 4 7 before authorizing robot initialization THE BD VIPER LT INSTRUMENT CONTAINS NO USER SERVICEABLE PARTS ALL MAINTENANCE AND REPAIR OTHER THAN THE PROCEDURES DESCRIBED IN SECTIONS 6 2 Routine Maintenance AND 6 2 4 As Needed Maintenance MUST PERFORMED BY BD QUALIFIED SERVICE PERSONNEL Yearly Preventive Maintenance is required to insure proper continued functioning of the instrument Scan all USB flash drives with anti virus software prior to inserting them into a BD Viper LT instrument USB port Do not remove the USB flash media during the update process Failure to follow this instruction could render your instrument inoperable DO NOT USE alcohol acetone or abrasive cleaners to clean the barcode scanner window If the recommended corrective actions do not solve the problem contact BD 500005363 02 BD Viper LT System User s Manual 1 12 500005363 02 2 Installation 21 General This section provides specifications for the BD Viper LT instrument and instructions for instrument con fig
154. nning any cleaning procedure please note all general cleanup cautions and warnings in 1 immediately below Routine cleaning for the BD Viper LT instrument includes the following Section Containing Cleanup Operation Frequency Full instructions Post run Cleanup After each run 4 9 2 End of Day Cleanup End of each day 4 9 3 Weekly Cleaning Once per week 6 2 2 Spill and Aborted Run needed 4 9 5 eanup A general cleaning chart is provided in Appendix F It is provided as a summary only Full cleaning instructions in the sections noted in column 3 should always be followed 4 9 1 General Cleanup Cautions and Warnings 1 WARNING Pathogenic microorganisms including Hepatitis viruses and Human Immunodefi ciency Virus may be present in clinical specimens Standard Precautions 1 4 and institutional guidelines should be followed in handling all items contaminated with blood and other body flu ids Clinical and Laboratory Standards Institute 2005 Approved Guideline M29 A3 Protec tion of laboratory workers from occupationally acquired infections 3rd ed CLSI Wayne Pa 2 Garner J S 1996 Hospital Infection Control Practices Advisory Committee U S Department of Health and Human Services Centers for Disease Control and Prevention Guideline for isolation precautions in hospitals Infect Control Hospital Epidemiol 17 53 80 3 U S Department of Health and Human Services 1999 Bios
155. nstrument the assigned location on the rack lights to indicate where to place the tube This continues until all specimens are logged in 1 3 2 3 Specimen Rack The specimen rack is used to hold specimen tubes during operations such as pre warming on the Pre warm heater cooldown etc The specimen rack has been designed for use with the BD Viper LT instrument Only this rack fits into the Pre warm heater and the specimen rack station 1 3 2 4 Barcode Scanner A peripheral barcode scanner is designed to allow manual scanning of barcodes during specimen login The barcode scanner is used to scan lot numbers rack barcodes and user provided accession barcodes 1 3 3 Instrument Software The instrument software presents a simplified user interface on the LCD monitor with buttons and icons to represent the functions operations setup parameters and status conditions Routine instru ment operations are performed by tapping the icon that corresponds to the desired activity Some of the basic displays include Main Status Display Figure 1 3 appears when instrument power up is complete shows current date and time software version instrument number LIS and door status locked unlocked Pre warm heater status buttons allow you to access all the instrument setup status and operation displays e Rack Login Display allows you to enter new specimen racks Start Run Display allows you to initiate runs Run Status Display
156. ntdown timer tap Yes to acknowledge the message and initiate the run immediately run begins automatically after a 10 second countdown After you confirm that you want to begin the run you are returned to the Main Status display and can proceed with other instrument operations such as logging in new specimen racks printing reports monitoring run status etc 500005363 02 5 31 BD Viper LT System User s Manual To Access the Start Run Display From the Main Status display tap the start run button If there is no rack defined the icon is grayed out and a small tube login image appears at the top right of the button If the robot is busy the icon is grayed out and a small run status image appears at the top right of the button gt If Weekly Maintenance is required the icon is grayed out and a small Fr weekly maintenance image appears at the top right of the button If one of the conditions listed below occurs the icon is grayed out and a small system alert image appears at the top right of the button conditions include system alert that would prevent a run from starting robot reader extractor not functioning tip alert Start Run Fields Specimen Rack Selection Window When the instrument cannot read the rack barcode the Start Run Rack Selection display Figure 5 16 appears This window shows up to 30 Ongoing specimen racks Initially the first rack is highlighted To select
157. ntrol photodiode are functioning correctly The calibration of the reader consists of determining correction factors for each well position due to parallax edge wells appear slightly dimmer The calibration is performed at the time that the machine is manufactured and is not subject to change since the relation of the plate to the camera is fixed 500005363 02 1 3 BD Viper LT System User s Manual Figure 1 2 BD Viper LT Instrument Interior SDA run Onboard Heating Cooling The thermal subsystem includes a heat block that accommodates SDA flat bottom C wells The block temperature is controlled by 24 Peltier type thermoelectric cells These cells can either heat or cool depending on the direction that DC current is flowing through them Each Peltier cell has a corresponding temperature sensor for closed loop temperature control of each zone within the heat block The Peltier cells share a common heat sink on the bottom to remove waste heat using a ducted fan out the back of the reader Liquid Crystal Display LCD Monitor and Touchscreen The LCD monitor is mounted on the left side of the instrument exterior It consists of an 1024 x 1280 pixel color LCD mounted in portrait orientation that presents information about instrument status and button definitions that enable you to perform instrument operations Button definitions and status information are frequently identified by icons that represent the type of information or o
158. ny portion was aborted To correct error replace all empty or partially empty pipette tip boxes with full ones and then run the Reset Tip Counters to Full function Configuration Maintenance Tools Manage Consum ables 500005363 02 1 23 BD Viper Instrument User s Manual EC 10006 General robot failure ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The robot has experienced a general failure CORRECTIVE ACTION S Effect The reader portion of the run in progress continues Future runs are prohibited Any run in progress that needs use of the robot is aborted NOTE You must repeat the run if any portion was aborted Error may be corrected by running Robot QC Configuration Maintenance Tools QC Functions Robot QC If error persists contact your local BD representative EC 10007 Robot initialization failure ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The robot has failed to initialize CORRECTIVE ACTION S Effect Future runs are prohibited Error may be corrected by running Robot QC Configuration Maintenance Tools QC Functions Robot QC If error pers
159. o Access the Instrument Alerts Display From the Main Status display tap the instrument alerts button Instrument Alerts Icons and Buttons View Alert Text View Alert Text button Instrument Alerts Fields In the middle of the Instrument Alerts display is a window where all persistent instrument alerts are listed These alerts are sorted in numerical order To refresh the error listing exit the display and then re access it Error codes are listed in Section 7 3 Error Message List with possible causes and suggested correc tive actions 500005363 02 5 57 BD Viper LT System User s Manual Power Distribution DIO Board E20001 7 30 2013 4 36 19 PM Figure 5 25 Instrument Alerts Display showing alert text 5 58 500005363 02 6 Maintenance 6 1 General The BD Viper LT instrument requires little maintenance from the user to provide reliable performance Periodic maintenance activities are described in Section 6 2 All other procedures are on an as needed basis and are described in Section 6 2 4 WARNING THE BD VIPER LT INSTRUMENT CONTAINS NO USER SERVICE ABLE PARTS ALL MAINTENANCE AND REPAIR OTHER THAN THE PROCEDURES DESCRIBED IN SECTIONS 6 2 Routine Mainte nance AND 6 2 4 As Needed Maintenance MUST BE PER FORMED BY BD QUALIFIED SERVICE PERSONNEL CAUTION Yearly Preventive Maintenance is required to insure proper continued functioning of the
160. odify Rack Display From the Main Status display tap the rack operations button From the Rack Operations menu tap the modify rack button The Modify Rack display appears Modify Rack Icons and Buttons modify rack indicator button Modify Rack Fields Specimen Rack Selection Window When the modify rack button is tapped the Modify Rack display Figure 5 12 appears This display shows all Ongoing specimen racks To modify a rack either a scan the rack barcode or b tap the desired rack in the selection win dow then tap the modify rack button The Rack Login display then appears You can add or delete specimens from the rack add or change accession numbers and modify kit numbers QC lot and Reagent You can only change the Assay to a compatible one Refer to the Rack Login Display fields for additional information 500005363 02 5 25 BD Viper LT System User s Manual Figure 5 12 Modify Rack Display Rack Selection 5 26 500005363 02 5 Reference 5 4 3 Copy Rack Display The Copy Rack display enables you to copy any aborted or completed racks This would be useful to save the effort of re logging in an aborted rack or one that was very similar or identical to a specimen rack that had already completed testing Note the following actions that occur when a rack is copied All specimen locations are copied to new rack with accession numbers and suppressed resu
161. ogin display fields is in Section 5 4 1 If you have an optional Lighted Login station place the specimen rack on the station Scan the rack barcode see Figure 3 3 Select the test type by tapping the drop down arrow next to the field if the default is not the desired test type and then tapping the test type in the list box 500005363 02 4 3 BD Viper LT System User s Manual Log in Required QC Quality Control Tubes 9 The first two positions A1 and B1 are reserved for the required positive and negative QC controls Note the following conditions A QC pair must be logged in for each amplification microwell lot number If 2 microwell lots are used on the rack then 2 QC control sets must be logged in Each QC pair on the rack can have a different lot number as can the positive and negative tubes within a required QC pair A QC pair must be logged in for each assay type if multiple types are used on a rack Note CTQx GCQx is considered a single assay type and only requires 1 QC pair A maximum of 4 QC pairs can be logged in for one rack Four pairs are required when 2 test types are used on a rack and each of the test types uses 2 lots The rack layout schema in this scenario is QC Pair Assay 1 Lot 1 Assay 1 Lot 2 QC Pair QC Pair Assay 2 Lot 1 Assay 2 Lot 2 QC Pair To enter the QC pair for the second lot of the first assay go to the Plate Layout display If you enter the second mic
162. ogress continues if detected during the consumables check Future runs are permitted Make sure the plate seal and plate seal tools are in their stations before starting a run EC 8011 Failure to move gantry ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument was not able to move the robot gantry away from the reader after sealing the plate CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted Robot End of Run activities are performed Future runs are permitted NOTE You must repeat the run if any portion was aborted Run Robot QC Configuration Maintenance Tools QC Functions Robot QC EC 9002 Tip fell off pipettor ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument has detected that a tip has fallen off of the pipettor head CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted Disposal Protocol and Volume QC functions are aborted if in progress Robot End of Run activities are not performed The reader portion of the run in progress continues Future runs are permitted NOTE You must repeat the run if any portion was aborted If the tip fell on the deck clean the deck and any areas in the vicinity with the appropriate cleaning so
163. on 2 10 500005363 02 2 Installation Maintenance Schedule Hour Minute Version Information 4 Viper LT V0 06F Serial Number LT25113 Instrument Number 1 Database Version 0 0 0 12 LIS Enabled False 4 Robot 1 1 0 31 CPU GetTypeInfoCount Channel 1 NimbusChannelOEM Channel 2 NimbusChannelOEM Channel 3 NimbusChannelOEM Channel 4 NimbusChannelOEM Puncture Tool NimbusChannelOEM 4 Reader Rachis Server 0 29 0 8 Simulated Machine Name PlateCycler Serial Number PlateCycler Simulator Controller Version Simulated Figure 2 3 System Tab 2 4 3 Tools Tab Refer to Section 5 8 1 for information on the Tools Tab 500005363 02 2 11 BD Viper LT System User s Manual 2 4 4 LIS Setup Tab LIS Setup enables you to set up parameters for communications with a Laboratory Information System LIS You can only access the LIS Setup tab when no runs are in progress Changes to any LIS parameters require the instrument to be rebooted to take effect Note that results are not uploaded at the following times e tube results are manually flagged for suppression for that assay Report results is unchecked for assay during tube login e tube has blank accession tube has error or failure run is not completed e tube is flagged as External Control or rehydration control during tube login Racks whose results are pending transmission to the LIS are marked with an asterisk in th
164. on 6 Maintenance explains all user instrument maintenance e Section 7 Troubleshooting provides a convenient guide identifying error codes and suggesting corrective actions Appendices contain a warranty maintenance log ordering information glossary and list of international contacts 1 5 Use of this Manual This user s manual is designed as a reference tool for technologists supervisors and other personnel who operate and maintain the BD Viper LT instrument on a regular basis Every attempt has been made to include all information which would be required during normal use and maintenance of the instrument Should a question arise which is not answered in this manual please contact the following parties USA For assistance with mechanical electrical or software performance operation procedures or reagents in North America a Technical Services 1 800 638 8663 International contacts are listed in Appendix D Other documentation required for proper instrument operation includes Assay and Reagent Package Inserts These documents contain important information on speci men preparation and the use storage performance and limitations of assays and reagents A package insert is included with each assay or reagent pack and is available upon request from BD BD Pre warm Heater Manual 8086781 This manual contains specifications operating instruc tions and important safety warnings for the BD Pre war
165. on 6 2 2 Weekly Maintenance 4 9 5 Aborted Run Cleanup In the event that a run is aborted certain areas of the instrument must be checked and cleaned if nec essary Required materials Hand pipettor Nitrile gloves Eye protection e g face shield goggles etc coat disposable or fresh clean Absorbent lab wipes e 196 v v sodium hypochlorite e Endocervical swabs 3 hydrogen peroxide do not use hydrogen peroxide from a container that has been open for longer than 8 days Alcohol pad or 70 Isopropanol 4 9 5 1 Consumables Cleanup e Remove all pipette tip boxes Discard any empty boxes Put aside any partially used boxes to return to the same stations after cleanup is complete 4 9 5 2 Spills Cleanup n the event of contamination of the work area or equipment with specimens or controls thoroughly clean the contaminated area with 196 v v sodium hypochlorite or 396 w v hydrogen peroxide do not use hydrogen peroxide from a bottle that has been open for longer than 8 days and rinse thoroughly with water Allow surface to dry completely before proceeding In case of a spill on the specimen rack immerse the rack in 1 v v sodium hypochlorite for 2 3 min Do not exceed 3 min Thoroughly rinse the rack with water and allow to air dry 4 9 5 3 Reagents Trough and or Extraction Tubes Cleanup If there is fluid in the extraction tubes or in the reagent trough follow this procedure e
166. onal If the error recurs contact your local BD representative EC 7006 Pipettor traversal error ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S A pipettor channel is not able to move to its final traversal height CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted A Disposal Protocol or Volume QC oper ation in progress is also aborted The reader portion of the run in progress continues Future runs permitted NOTE You must repeat the run if any portion was aborted Message is informational If the error recurs contact your local BD representative EC 7007 Invalid pipettor data ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The pipettor generated invalid data CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted A Disposal Protocol or Volume QC oper ation in progress is also aborted The reader portion of the run in progress continues Future runs are permitted NOTE You must repeat the run if any portion was aborted 7 16 500005363 02 7 Troubleshooting Message is informational If the error recurs contact your local BD representative EC 8001 Plate seal missing unable to pick up plate seal ALERT TYPE Self Clearing
167. orrect an instrument malfunction contact your local BD representative This section discusses error messages which appear when the instrument has encountered a known problem These messages are listed in numerical order along with possible causes of the message and corrective actions 500005363 02 7 4 BD Viper Instrument User s Manual 7 2 System Messages CAUTION When the instrument notifies you of alerts and errors you should immediately respond to the condition Instrument alerts are conveyed as follows alert tone repeating low pitch beep sounds instrument alert button may be activated on the Main Status display message box pops up The message box contains a general description of the error and a code that begins with a letter e g Power Distribution DIO Board E20001 The errors must be acknowledged by tapping the OK but ton to dismiss the message box The underlying display does not update as long as the message box is active Different types of alerts and errors behave in different ways There are two basic types of alert condition 1 Self Clearing these alerts are removed from the screen after they have been displayed and acknowledged No other intervention is required 2 Persistent these alerts remain in the Instrument Alert Screen even after displaying the alert code until the instrument determines that the error causing the alert has been corrected Cor rection can be
168. ot gan try to that location 4 Perform the desired cleaning or bag replacement activities Be sure to return the robot gantry to its home position To do so tap the move robot gantry button on the right side of the deck graphic 6 32 500005363 02 6 Maintenance uu Tap this button to move the robot gantry to this location Figure 6 16 Move Robot Gantry Reader Display 500005363 02 6 33 BD Viper LT System User s Manual To Lock Unlock the Door 1 Access the Move Robot Reader function as described above 2 The lock unlock door button appears in the opposite state to that of the actual door lock Meaning if the door is currently locked the button state is unlock door If the door is unlocked the button is lock door Observe the current state of the door at the top right of the display 3 Tap the lock unlock door button to change the door lock state Note that the door cannot be locked if it is open 4 Verify that the desired lock unlock state has been achieved by trying to open the door If you lock the door remember to unlock it when you have completed your activities The door remains manually locked until you tap the unlock door button To Move the Reader Normally after a run is complete the reader opens so that you can remove the used amplification plate If the reader does not open due to an aborted run or error you can use the Move
169. oubleshooting 7 3 Error Message List System error codes are presented below in numerical order Other messages appear during system operation Workflow alerts also appear in popup boxes and generally result from a failure to perform some action exactly as the system expected The message box that appears explains what the prob lem is and how to resolve it Workflow errors are not listed below because the message box itself explains what occurred and how to correct the problem NOTE Be aware that when a Corrective Action recommends that you cycle instrument power any run or Pre warm protocol that is currently in progress is aborted If possi ble wait until the run or protocol completes before rebooting the instrument CAUTION If the recommended corrective actions do not solve the problem contact BD EC 1001 Transfer and Amplification Step Timer expired ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S During a High Throughput run the Max Prime Timer or Max Extractor Timer expired CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted The reader portion of a run continues Future runs are permitted This error can occur when you do not respond to the Transfer and Amplification Message before the timers named above expire Be alert to any messages that occur during the run especial
170. ound to ferric oxide in the extraction tubes is held to the sides of the tube as specimen waste is removed and discarded by the pipettor From there the DNA is removed from the extraction tubes and transferred to priming micro wells 500005363 02 1 Introduction BD Viper LT Figure 1 1 BD Viper LT Instrument Reader The reader employed in the Viper LT System is a self contained assembly capable of performing SDA in flat bottom C wells in a 96 well format The reader incorporates four optical channels to read up to four fluorescent dyes in each reaction well It uses filtered LED excitation and filtered imaging based camera detection The camera is mounted above the wells or tubes and reads through a clear plate seal which is applied by the robot The thermal system includes a Peltier based temperature controlled heat block for executing isothermal protocols and a heated lid to pre vent condensation from forming on the plate seal Instrument Calibration The BD Viper LT instrument fluorescence reader s optical system comprises one camera with selectable filter and eight illumination LEDs light emitting diodes two per optical channel The camera is a stable CCD device that requires no direct calibration or correction The LED illumination is controlled by a control photodiode near the SDA plate position using an active feedback loop a second photodiode is located near the first constantly insures that the LEDs and co
171. outine checks of accuracy and precision are not required However if you want to periodi cally check the accuracy and precision of the pipettor the following procedure enables you to verify that the pipettor transfers fluid within specifications Required Materials Deionized water Empty Extraction Reagent trough 12 empty dry specimen tubes 12 P caps Full pipette tip box Analytical balance capable of measuring to three decimal places 0 001 grams Procedure 1 Rack Setup Weigh each of the 12 dry empty specimen tubes with P caps Record the initial weight on the Volume QC Log immediately following these instructions Place the tubes into the recorded positions on the specimen rack Specimen tubes must occupy positions A1 H1 and A2 D2 in the specimen rack When all tubes are weighed and inserted into the rack place the specimen rack in the rack station 6 46 500005363 02 6 Maintenance 2 Trough Setup Place the empty extraction reagent trough in its station Add 100 mL of deionized water room temperature to the wash trough located in the fourth position from the left or second from the right 3 Pipette Tip Setup Make sure all pipette tip stations are populated with full boxes of tips If necessary use the Configuration Maintenance gt Tools gt Manage Consumables gt Reset Tip Counters function to manually reset all counters to full after manually replacing all tip boxes with full ones see Se
172. ox to select it Hours are displayed in 24 hour international format e g 7 p m is shown as 19 To see numbers above or below the ones displayed drag the scrollbar in the drop down box up or down You can select an hour value from 00 to 23 Minute To adjust the minute value tap the Minute field and then tap the desired hour in the drop down box to select it You can select a minute value from 00 to 59 Sound Select the volume of the instrument s audible alarm The default setting is the third increment of 11 To increase or decrease the volume tap and drag the bar to the left to decrease the volume or to the right to increase the volume To hear a sample volume tone tap the Test button You can choose from 0 audible alarm off to 11 loudest Version Information This window presents read only information about the instrument software and database The following information is presented Instrument Software Version Serial Number Instrument Number 500005363 02 2 9 BD Viper LT System User s Manual Database Version LIS Enabled True False Pre warm Controller Application CRC Boot Loader Version Hardware Identifier Compatibility Revision Reader Software Version Machine Name Serial Number Controller Version FPGA Version PCB Version Comm Version Robot Software Version CPU Channel 1 identification Channel 2 identification Channel 3 identification Channel 4 identification Puncture Tool identificati
173. p to 20 characters Select either the Positive or Negative radio button Tap the Save button to save the information You can designate optional QC tubes singly or in pairs and Tubes designated for rehydration are marked with a droplet on the Rack Login display The Rehydrate checkbox does not appear for required Quality Control tubes 4 6 500005363 02 4 Operation NOTES Optional QC Rehydration tubes are not indicated as Quality Control tubes on any report or display These tubes are tested and results are reported and uploaded to LIS if configured as ordinary specimens These optional controls are marked on the Tube Result Report with the rehydration droplet icon If you manually rehydrate a tube marked for rehydra tion it causes a liquid level error during processing and causes the run to abort f you erroneously mark a normal specimen tube for rehydration it fails rehydration fluid checks and causes the run to abort A message appears if this occurs and specifies the tube location that failed A maximum of 10 QC tubes required plus optional can be run on a specimen rack 13 To withhold reporting results for a tube only available for dual test assays tap the radio button next to the assay in the Reported results box that you do want to be reported on Tube Result Report and uploaded to LIS if configured The assay type next to the empty radio button will not be r
174. peration that can be performed A comprehensive list of instrument icons is presented in Section 5 5 Refer ence Barcode Scanners Two barcode scanners are located on the instrument deck one at the specimen rack station and one at the extraction reagent trough There is also a built in barcode scanner on the Pre warm heater that reads the specimen rack barcode A separate hand held scanner is provided to help automate specimen login and identification 1 4 500005363 02 1 Introduction 1 3 2 System Peripherals 1 3 2 1 BD Pre warm Heater The BD Pre warm heater is used to pre warm specimens and assay controls The heater is connected to the BD Viper LT instrument and communicates with the instrument When a specimen rack previ ously logged in is placed on the heater the barcode scanner scans the rack barcode and automati cally selects the correct warming protocol for the assay logged in for that specimen rack Heater status is updated periodically on the Main Status display in the Pre warm window at the bottom of the display Specimens and assay controls must be pre warmed before they can be tested on the BD Viper LT instrument 1 3 2 2 Lighted Login Rack The optional Lighted Login rack assists in correct specimen tube placement during specimen login The rack is connected to the BD Viper LT instrument Before starting specimen login the specimen rack is placed on the Lighted Login rack As a tube is logged in at the i
175. popup alert window POSSIBLE CAUSE S An error occurred when the reader attempted to calibrate the optical mask CORRECTIVE ACTION S Contact your local BD representative EC 5001 System configuration data corruption ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The configuration file is either missing or corrupted CORRECTIVE ACTION S Effect All configuration values are reset to the default values Future runs are permitted 7 14 500005363 02 7 Troubleshooting Check and reset your configuration settings if needed Configuration Maintenance Instrument Configuration Maintenance System and Configuration Maintenance LIS Setup EC 5002 Rack database corruption ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S A specimen rack creation date is in the future relative to the current system date time CORREC TIVE ACTION S If the rack is untested delete the rack in question and log it in as a new rack EC 5004 New assay configuration error ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S An error has been detected in an assay definition file CORRECTIVE ACTION S
176. ppears advising you that the robot s 4 channels have been moved to the cleaning position If a pre warm protocol is in progress wait until the protocol completes before proceeding 500005363 02 BD Viper LT System User s Manual Turn off instrument power Perform weekly cleaning as described below Weekly Cleaning Turn on instrument power 8 The maintenance function can only be aborted before the second stage otherwise the entire maintenance is performed To abort the QC function while it is in progress tap the abort but ton In the confirmation window tap the Yes button to abort the function or tap the No but ton to proceed with the QC function 9 When the function is complete the status is displayed at the right of the menu selection H pass indicator fail aborted indicator Weekly Cleaning 1 When the Weekly Cleaning message appears turn off the Viper LT instrument P Notification N614 mo instrumented portion of weekly maintenance is complete and the channels have 2 been moved to their cleaning position Turn off power to the instrument Clean the channels per documented procedure Turn the instrument back on DO NOT turn the instrument off if a Prewarm protocol is active Wait until the Prewarm protocol is complete and then turn off power Figure 6 6 Weekly Maintenance Message 2 Gently pull down one pipette channel Note Avoi
177. press the Yes button to begin the timing critical step or your run will be aborted Remaining time mm ss is counted down in the message box If this is the first run of the day verify that you have loaded the amplification plate and tap the Yes button when ready to begin the heat and transfer step If this is the second third etc run being performed in High Throughput mode you must remove the old sealed amplification plate after the reader opens change gloves and place a new amplification plate onto the reader amplification stage The instrument unlocks the door check the door indicator to confirm to permit access to the instrument interior Tap the Yes button to proceed to the heat and transfer step e instrument next checks the amp plate before and after sealing via a tip touch A notification message appears if an improper plate is detected and the heat spike does not begin Do not respond Yes until you check the plate to determine what the problem is When you have corrected the problem then tap the Yes button to continue the run If you cannot determine the source of the problem you can tap the No button at this stage to abort the plate s 9 When robot activities are complete the End of Robot Activities tone sounds You can open the door to perform post run cleanup Section 4 9 2 and add the new specimen rack new tip boxes where needed new reagent trough and extraction tubes next Priming plate and
178. problem run Reader QC Configuration Maintenance gt Tools gt QC Functions gt Reader QC If the error recurs contact your local BD representative EC 4010 Reader thermal fan performance error ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The reader has detected significant fan performance degradation CORRECTIVE ACTION S Contact your local BD representative 500005363 02 7 13 BD Viper Instrument User s Manual EC 4011 Reader thermal lid performance error ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The reader has detected significant thermal lid performance degradation CORRECTIVE ACTION S Contact your local BD representative EC 4012 Reader illumination performance error ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The reader has detected significant illumination performance degradation CORRECTIVE ACTION S Contact your local BD representative EC 4013 Reader optical mask calibration error ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the
179. re you should place the tube When you save or cancel the specimen login on the Tube Login display the LED for that station extinguishes LEDs also extinguish if you exit Tube Login access Plate Layout or access Extraction Login displays or if you disconnect the station from the instrument See Figures 3 7 to 3 9 To use the Lighted Login station place the specimen rack over the station The specimen rack fits on the Login station in one orientation only Log the tube in on the Rack Login display then place the tube in the rack where the blue LED illuminates Continue with additional specimens until all the desired tubes are logged in and placed in the rack The base and tube alignment block separate to allow thorough cleaning The tube alignment block can be submerged in a solution of sodium hypochlorite as recommended in Section 4 9 Cleanup The base can be wiped with any of the recommended cleaning solutions but should not be submerged To reassemble the station place the tube alignment block back on the base making sure to fit the 2 guide pins on the base into the appropriate holes in the tube block see Figure 3 8 The USB cable see Figure 3 8 for connector location provides both power and communication to the station n E Figure 3 7 Lighted Login Station assembled Co 500005 3 02 C BD Viper LT System User s Manual t3 Figure 3 8 Lighted Logi
180. ree wipe On the instrument deck wipe the deck surfaces in tip waste bin area with a lab wipe damp ened with 3 hydrogen peroxide Rinse by wiping with tap water Wipe the channel check square with a lab wipe dampened with 396 hydrogen peroxide Rinse by wiping with a wipe dampened with tap water Channel Check Square Extraction Rack p Figure 6 9 Channel Check Square Location 14 Place a fresh tip waste liner in the tip trash bin and place the bin back on the instrument Close the instrument door 15 Turn instrument power back on 16 If the waste bottle is less than 1 full skip the rest of this step and proceed to Step 12 If the waste liquid bottle is more than full unscrew the cap and pour approximately 400 mL of undiluted commercial bleach directly into the waste bottle Pour the liquid slowly to prevent splashing e Disengage the quick release on the waste tubing and remove the waste bottle Agitate the waste container by twisting wrist back and forth 15 20 times while holding the bottle by the handle 6 14 500005363 02 6 Maintenance 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Allow to sit for at least 30 minutes After at least 30 minutes unscrew the waste liquid bottle lid and remove Hold the waste container by the handle with one hand and hold the bottom of the container with the other hand to assist in pouring the waste liquid down a sink dr
181. rence Figure 6 4 Rear Disconnect Tip Rack Tray 6 10 500005363 02 6 Maintenance Figure 6 5 Disconnects Trough Tray Remove the reagent trough rack by loosening the 2 disconnects see Figure 6 5 Clean the pipette tip rack and reagent trough rack by submerging in 196 v v sodium hypochlo rite solution for 2 3 minutes Rinse thoroughly with tap water and allow to air dry Be careful when replacing tip rack holder to not pinch or snag any wires or cables on near the Priming stage To perform Weekly Maintenance 1 2 3 Access the Weekly Maintenance function as described above Tap the start button to initiate the QC function In the confirmation window tap the Yes button to proceed or tap the No button to cancel the function If you select No you are returned to the QC menu If a rack is present in the specimen rack station a message appears informing you that the rack must be removed for the QC to proceed Remove the rack and tap the Yes button to proceed A message appears advising you to make sure the specimen rack is removed Tap the Yes button to proceed When the confirmation window appears confirm that the instrument door is closed Then tap the Yes button to proceed Tap the No button to cancel the function If you select No the function is aborted The automated portion of Weekly Maintenance is then performed When the automated por tion is complete a message a
182. returned to the Plate Layout zoomed display prm c 2 Modify Microwell Lot Lot Number Expiration Date 1213123 2012 12 12 Save Cancel Figure 5 8 Modify Microwell Lot Window Plate Layout Buttons Zoom button Tap a plate to zoom into the individual plate display rotate button Tap to rotate the display 90 clockwise landscape orientation Tap again in the rotated view to rotate the display 90 counter clockwise and return to portrait orientation microwell lot button Tap a microwell location to pop up the Modify Microwell Lot window You can enter or modify the lot number or expiration date of the microwells provided that position is eligible for a lot number change Positions where a lot number change would result in an invalid plate configu ration e g if the change would result in insufficient QC coverage are ineligible for a lot num ber change and those positions do not respond if you tap their location If there is no default microwell lot defined then all the microwells except the first one are ineligible for change 5 20 500005363 02 5 Reference Figure 5 9 Plate Layout Display zoomed Asterisks indicate new kit lot number assigned not yet saved print button Tap to print the current Plate Layout display exit button Tap to exit the display Newly entered information is saved automatically 500005363 02 5
183. robot portion of cycle run complete Workflow No USB drive inserted when Two tones descending muted Export Data function is selected trumpet Alert Temperature alert Single low pitch beep repeating 3 16 500005363 02 4 Operation 41 General This section describes the routine operation of the BD Viper LT instrument The following major topics are discussed Using the Instrument Interface Section 4 2 Preparing Specimens Section 4 3 Logging in Specimen Tubes Section 4 4 Preparing the Instrument Section 4 5 Tube and Run Statuses Section 4 6 Starting a Run Section 4 7 Responding to Alarms and Errors Section 4 8 Cleanup Section 4 9 Power Failures Section 4 10 500005363 02 BD Viper LT System User s Manual 4 2 Using the Instrument Interface The Liquid Crystal Display LCD presents all the information needed to view instrument status and operate the instrument The information is presented on displays with icons that represent instrument operations The display presents information progress bars and prompts for the operation currently being performed The screen is touch sensitive meaning you can simply touch or tap the button or icon on the screen itself to perform the associated action As you initiate instrument activities the messages in the main body of the display guide you through the operations and new buttons may appear that present additional options All the icon
184. rom the Rack Login display tap the print button The Tube Layout Report provides the following information Report Header Instrument Name Title Tube Layout Report BD Logo Assay Date and time that rack was defined Instrument number Rack number and barcode Current system software version Technician blank line for signature Main Body of Report Report is organized by Rows A H and Columns 1 6 simulating the layout of a rack Positive negative QC specimens show QC or QC and lot number Specimen tubes show Accession centered in each report cell where a specimen has been logged in Rehydrated samples show the lot number entered External controls show the Manufacturer Id entered Unused rack locations are indicated by light gray cell outlines Suppressed results are indicated within a slashed oval in the applicable cells E g CPQx 5 40 500005363 02 5 Reference BD Viper LT e CTQx GCQx Tube Layout Report BD 10 19 2012 3 31 57 PM Instrument 1 LT25113 Rack 1 12345 V0 06F Technician 1 2 3 4 6 QC 1234567 QC 1234567 CONTROLZRU S Figure 5 19 Sample Tube Layout Report 500005363 02 5 41 BD Viper LT System User s Manual 5 7 2 Tube Result Report The Tube Result Report shows the test results for racks that have completed testing Reports cannot be printed for racks that have not been tested are currently being tested
185. roperly or there may be a hardware failure CORRECTIVE ACTION S Effect The robot portion of a run in progress continues unless it requires the reader to complete the protocol The reader portion of the run in progress is aborted Future runs are prohibited NOTE You must repeat the run if any portion was aborted To correct the problem run Reader QC Configuration Maintenance Tools QC Functions Reader QC Contact your local BD representative if Reader QC does not resolve the problem EC 4004 Reader thermal error ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The reader experienced a thermal error CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted The reader portion of the run in progress is aborted Future runs are prohibited NOTE You must repeat the run if any portion was aborted To correct the problem run Reader QC Configuration Maintenance gt Tools gt QC Functions gt Reader QC If problem persists contact your local BD representative EC 4005 Reader motion error ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window 500005363 02 4 11 BD Viper Instrument User
186. rotocols As with an aborted protocol any reagents remaining in the troughs or extraction tubes remain potentially caustic and or infectious You should re run the appropriate disposal protocol s before attempting to remove reagents manually H pass indicator fail aborted indicator 6 Dispose of any tubes and or troughs as recommended in Section 4 9 5 To Reset Tip Counters to Full If you replace partially full pipette tip boxes with full boxes you should manually reset the tip coun ters to full status Instead of manually consolidating tip boxes and resetting the tip counter you can save time by using the automatic Consolidate Pipette Tips function described below 1 To reset tip counters manually tap the reset tip counters button 2 A message appears asking you to confirm that you want to reset tip counters to full Verify that all pipette tip boxes are full then tap the Yes button If you cannot confirm that the boxes are all full or if the boxes are not full tap the No button You are returned to the Manage Consumables menu 6 28 500005363 02 6 Maintenance Manage Consumables Empty Extraction Tubes Consolidate Pipette Tips Figure 6 14 Manage Consumables Display 500005363 02 6 29 BD Viper LT System User s Manual To Consolidate Pipette Tip Boxes The Consolidate Pipette Tips function
187. rowell lot number the system prompts you to enter the second QC Lot number when you exit the Tube Login display or change the test type if you have not already done so Asterisks in the wells indicated new unsaved lot numbers Number of Number of Microwell Kits Number of QC Sets Assays per Assay and Required 1 1 1 2 2 2 1 2 1 of first assay 2 of second 3 2 4 You can log in optional QC tubes for testing up to 10 total required plus optional These tubes are tested as regular specimens and do not affect the Pass Fail status of the run See Step 12 of Logging in Specimen Tubes below To assign a QC lot number to the QC specimens tap the positive QC position or scan the positive QC tube barcode Type in the QC lot number or scan the barcode The lot number must be entered before you can exit the Rack Login display 4 4 500005363 02 4 Operation CTQx GCQx fa Last Tube D01 CONTROLZRUS i ELA 4 w 000000 0600000 000000 000000 000000 0600000 000000 Lot Numbers QC CTQx GCQx 01 01 1234567 Ext Tube CTQx Well GCQx Well Plate 1 A01 F03 1232434 Plate 1 A02 F04 4654646 Figure 4 1 Rack Login Display 500005363 02 4 5 BD Viper LT System User s Manual Logging in Specimen Tubes 10 Each circle represents a specimen tube location in the specimen rack Solid blue indicates an
188. rtion of a run in progress is aborted The reader portion of a run continues Future runs are permitted Run the Disposal Protocol Configuration Maintenance Tools Manage Consumables Empty Reagent Troughs to empty reagent reservoirs then replace the trough NOTE You must repeat the run if any portion was aborted EC 1011 Liquid detected in liquid waste ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S Liquid is detected in the waste liquid reservoir on the deck CORRECTIVE ACTION S Effect If detected at the beginning of a run the run is aborted If detected before emptying the trough during a run the trough is not emptied There is no impact to the run in progress When detected during a disposal protocol the protocol is aborted To correct the problem check the following Waste liquid bottle if full empty it according to Cleanup recommendations Section 4 9 Waste liquid tube check for kinks or obstructions correct if necessary Waste liquid bottle cap verify that cap is on correctly correct if necessary 7 6 500005363 02 7 Troubleshooting Waste liquid check valve on waste bottle check if valve is stuck defective or disconnected correct if necessary If problem recurs contact your local BD representative NOTE You must repeat the run if any portion was aborted EC 1012
189. s Manual POSSIBLE CAUSE S The reader experienced a motion error Possibly an object is blocking the reader door CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted The reader portion of the run in progress is aborted Future runs are prohibited NOTE You must repeat the run if any portion was aborted To correct the problem open the instrument door and check around the reader to see if something is blocking or impeding motion Run Reader QC Configuration Maintenance Tools QC Functions Reader QC if you remove any items that were impeding motion or if there were no items located If problem persists contact your local BD representative EC 4006 Reader optics error ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The reader has experienced an optical error CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted The reader portion of the run in progress is aborted Future runs are prohibited NOTE You must repeat the run if any portion was aborted To correct the problem run Reader QC Configuration Maintenance gt Tools gt QC Functions gt Reader QC If problem persists contact your local BD representative EC 4007 Reader configuration error ALERT TYPE Persistent Cleared wh
190. s may monitor more frequently based on laboratory workflow and volume of testing 1 oN Oo C For each area to be tested use a clean collection swab as specified below BD ProbeTec Collection Kit for Endocervical or Lesion Specimens Catalog number 441357 Pour off some Molecular Biology Grade Nuclease free water into a small clean container Dip the swab into the molecular biology grade nuclease free water and wipe the first area using a broad sweeping motion Remove the cap of a Q Swab Diluent tube and insert the swab into the Diluent Express the swab in the Q Swab Diluent for 5 10 s For monitoring with SDA assay type break the shaft of the swab at the score mark Use care to avoid splashing of contents Break the shaft of the swab at the score mark Use care to avoid splashing of contents Tightly recap the Diluent tube with the black pierceable cap Repeat for each desired area After all swabs have been collected and expressed in diluent pre warm and test them as described in Section 4 Operation The recommended areas to test are Reagent trough lockdowns Extraction rack station Specimen rack station Plate Seal Station Priming stage Amplification stage Door handle Monitor touchscreen Pre warm heater Laboratory benchtops If an area gives a positive result or if contamination is suspected clean the area as per the cleaning instructions Make sure the entire area is wetted with the solution and allowed
191. specimen racks To copy a rack either a scan the rack barcode or b tap the desired rack in the selection win dow then tap the copy rack button When the confirmation message appears tap the Yes button to confirm that you want to copy the rack The rack is copied and the system automati cally generates a new tube rack number The Rack Login display then appears and you can make any modifications allowed by the Mod ify Rack display function Refer to Modify Rack Display Section 5 4 2 for additional information 5 4 4 Delete Rack Display The Delete Rack display enables you to delete any Ongoing specimen racks See Figure 5 14 To Access the Delete Rack display From the Main Status display tap the rack operations button From the Rack Operations menu tap the delete rack button The Delete Rack display appears Delete Rack Icons and Buttons delete rack indicator button Delete Rack Fields Specimen Rack Selection Window When the delete rack button is tapped the Delete Rack display Figure 5 14 appears This window shows all Ongoing specimen racks To delete a rack either a scan the rack barcode or b tap the desired rack in the selection win dow then tap the delete rack button When the confirmation message appears tap the Yes button to confirm that you want to delete the rack 500005363 02 5 29 BD Viper LT System User s Manual Figure 5 14 Delete Rack Displa
192. splay The associated locations for these tubes are shown also Note that QC lot numbers are assigned in the Rack Login display assay lot numbers are assigned in the Plate Layout display and extraction tube lot numbers are assigned in the Extraction Lot Login display Reagent trough lot numbers are read from the troughs by an onboard barcode scanner Continue the login process with Section 4 4 2 Extraction Lot Login and Section 4 4 3 Setting up Plates 4 4 2 Extraction Lot Login The login process also includes logging in extraction tube lots as described below 1 When all specimens are logged in tap the extraction lot button to view the Extraction Lot Login display see Figure 4 3 Note that the button is grayed out and Extraction Lot Login cannot be accessed if no specimen tubes are logged in Tap a black location to enter the extraction tube lot number Type in or scan the extraction tube lot number or barcode A maximum of 2 lot numbers can be used in a single run You do not have to log in the reagent trough lot number it is read by the onboard scanner Tap the exit button to return to the Tube Login display Be sure to load extraction tubes where indicated on the Extraction Lot Login display as the marked wells are where the instrument dispenses specimens for extraction 4 8 500005363 02 4 Operation Figure 4 3 Extraction Lot Login Display BD Viper LT System User s Manual
193. ssage is informational Effect The robot portion of the run in progress is aborted The reader portion of a run in progress continues Future runs are permitted NOTE You must repeat the run if any portion was aborted EC 1004 Pre wet check failure ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The Lysis KOH pre wet process failed 2 times 7 4 500005363 02 7 Troubleshooting CORRECTIVE ACTION S Message is informational Effect The robot portion of a run in progress is aborted The reader portion of a run continues Future runs are permitted NOTE You must repeat the run if any portion was aborted If error recurs frequently contact your local BD representative EC 1005 Run aborted ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S This alert occurs as a result of another alert condition or workflow error that causes a run to abort or if you manually abort the run CORRECTIVE ACTION S Effect Future runs are not prohibited by this alert but may be prohibited by other alert conditions that occurred at the same time NOTE You must repeat the run if any portion was aborted EC 1006 Inadequate amp well condition for amplification ALERT TYPE Self Clearing Cleared when the al
194. stalled in an area that is free from undue vibration high humidity dust temperature extremes and corrosive or explosive vapors or gases The bench used to support the BD Viper LT instrument must be able to support 500 Ib and should be level Room temper ature must be between 18 33 C 64 4 91 4 F Relative humidity RH must be between 20 85 RH non condensing Four inches of clearance on the sides of the instrument must be allowed for ven tilation and eight inches in the rear Additional bench space may be desirable for nearby placement of the BD Pre warm heater optional UPS printer and optional lighted login rack Environments which exceed these limits could adversely affect the performance of the instrument components The use of earthquake anchoring see above is recommended in areas susceptible to earthquake activity Contact your BD representative for information on earthquake anchoring The BD Viper LT instrument is to be installed by BD representatives only 2 4 Instrument Setup The instrument ships with all setup parameters preset to factory default values However before using the instrument for sample testing you should review the setup parameters to see if they are suitable for your laboratory These parameters include Instrument Tab Section 2 4 1 Instrument Number Walkaway Enable Disable Available Assays Default Assay e System Tab Section 2 4 2 Maintenance Schedule e Sound volume Version I
195. strument to rehydrate it Do not check the box if you manually rehyarate the tube or if you want to designate the tube as an External Control When you select the Rehydrate checkbox the Login window changes See Figure 5 5 Rehydrated tube results are reported the same as specimen tube results however these results do not affect reporting of specimen results for the rack Tubes designated for rehydration are marked with a droplet on the Rack Login display Lot Number Enter up to 20 characters to identify the lot number of the control This information is optional but highly recommended You cannot use the following characters 2 41 gt eue Tube Login E01 A Lot Number Rehydrate a External control Positive Negative Delete Cancel Figure 5 5 Tube Login Window for Rehydrated Optional Control Positive radio button 5 14 500005363 02 5 Reference Select to designate the tube as the positive control You must designate a rehydration control as either Positive or Negative Negative radio button Select to designate the tube as the negative control You must designate a rehydration control as either Positive or Negative External control checkbox Check this box to designate the tube as an External control NOTE checking this box disables the Rehydrate checkbox External control results are reported the same as specimen tube results W
196. surrounding area Note Make sure that the amplification heater is free of debris The presence of debris such as bits of paper gauze etc will interfere with temperature uniformity and pipetting accuracy Change lab wipe and clean the area surrounding the waste tip bin and the waste disposal sta tion Wipe the door handle the monitor and outer instrument covering Change lab wipe and wipe the outside of the quick release on the waste tubing with 196 v v sodium hypochlorite After 2 3 minutes change gloves and repeat the entire process with lab wipes dampened with tap water Change lab wipe as indicated in previous steps while wiping down with water Make sure that traces of cleaning solution are rinsed away Repeat the rinse step if necessary Clean the plate seal tool suction cups and the pins on the plate seal station with an alcohol pad 500005363 02 BD Viper LT System User s Manual 32 Dampen a lab wipe with 196 v v sodium hypochlorite or 396 hydrogen peroxide and wipe the surface of the Pre warm heater Follow with a lab wipe dampened with tap water 6 2 3 Monthly Maintenance 6 2 3 1 Monitoring for the Presence of DNA Contamination At least monthly you should perform the following test procedure to monitor the work area and equip ment surfaces for the presence of DNA contamination Environmental monitoring is essential to detect contamination prior to the development of a problem Laboratorie
197. t number suppressed result location indicator overlays well location CTQx assay Priming well microwell lot button GCQx assay Priming well microwell lot button CTQx assay Amp well io GCQx assay Amp well d microwell lot button microwell lot button rotate button on zoomed print button display Plate Layout Fields Rack information Rack information appears at the top left of the display The rack number appears above the plate layout indicator The Barcode field shows the rack barcode to the right of the plate lay out indicator The Created field shows the date when the rack was defined Plate Layout The placement of microwells is shown in a color coded layout display The colors correspond to the colors of the Priming and Amplification microwells for the particular assay White circles represent unused microwell locations as well as microwells with suppressed results Several symbols can overlay a well location a plus symbol indicates the positive QC specimen a minus symbol indicates the negative QC specimen a droplet indicates a rehydrated speci men an asterisk indicates a new not yet saved lot number Priming microwells are shown in the left plate and amplification microwells are shown in the right plate Microwells do not correspond to specimen tube locations due to the algorithms used to optimize robot movement To zoom into a plate tap
198. t of three pick up attempts CORRECTIVE ACTION S Effect The robot portion of a run in progress continues Robot End of Run activities are performed The reader portion of the run in progress continues Future runs are prohibited Run disposal activities continue however the instrument does not perform tip consolidation To correct error replace all empty or partially empty pipette tip boxes with full ones and then run the Reset Tip Counters to Full function Configuration Maintenance Tools Manage Consum ables EC 9007 Tip ejection into tip box failure ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument failed to return tips to a tip box CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted The reader portion of the run in progress continues Disposal Protocol and Volume QC functions are aborted if in progress Future runs are prohibited NOTE You must repeat the run if any portion was aborted The instrument does not perform tip consolidation 7 22 500005363 02 7 Troubleshooting To correct error replace all empty or partially empty pipette tip boxes with full ones and then run the Reset Tip Counters to Full function Configuration Maintenance Tools Manage Consum ables Tip Stuck in a Spec
199. t perform QC functions during a pre warm protocol Pre warm Heater Rack 12 Barcode 00212 px 004538 Figure 4 5 Pre warm Heater Window 500005363 02 4 13 BD Viper LT System User s Manual 4 5 Preparing the Instrument 4 5 1 Assays To prepare the BD Viper LT instrument for specimen processing and testing perform the activities listed below in Procedure The Procedure recommends consumable loading in a roughly back to front strategy See Figure 4 8 for placement of consumables Required Materials Nitrile gloves Full pipette tip boxes 5 Extraction reagent trough Extraction tubes Clear Viper LT plate seal Priming plate loaded with assigned microwells for the run Amplification plate loaded with assigned microwells for the run Pre warmed specimen rack loaded with specimen tubes for the run Neutralization pouch Waste bottle Waste tip bin liner Absorbent pad from reagent trough kit Procedure WARNING ACID AND BASE SPILL KITS SHOULD BE ON HAND IN THE EVENT OF A SPILL OF EXTRACTION REAGENTS 1 Change gloves 2 Verify that the waste tip bin is at least half empty If the bin is more than half full move the robot gantry Section 6 2 4 5 and remove the existing bin liner Replace with a new waste bin liner containing an absorbent pad To replace the liner make sure the alignment stripe is aligned with the top of the waste bin and press the liner down into the bin s bottom corn
200. t the second assay tap the Assay field at the location where you want to switch and select the second assay The instrument automatically places a positive and negative control tube in the first 2 locations at the change position You can log in specimen tubes after the control tubes Last Tube The Last Tube field appears after a specimen tube has been logged in and saved It shows the location of the last specimen tube logged in or deleted QC pairs show the control kit num ber below the location specimen tubes show the accession if entered Deleted tubes show the word Deleted to the right of the location e g B02 Deleted Lot Numbers Window As specimens and reagents are logged in the Lot Numbers Window is populated with any assigned lot numbers for these reagent types QC kit numbers assay kit numbers and extrac tion tube lot numbers The locations of assigned lot numbers are also shown If a second lot is used for a particular reagent type it is shown on a second line under the reagent heading Infor mation in this window is read only k Layout Each circle represents a specimen tube location in the specimen rack The circle colors corre spond to the assay type and whether any results are suppressed from reporting Positive con trols have plus sign in the circle Negative controls have a minus sign in the circle Rehydrated specimens have a droplet in the circle To log in a tube tap an available
201. tabases are initialized event logger is initialized pre existing alerts and configuration values are loaded communication is verified with the following components specimen rack sensor scanners temperature controllers temperature channels LIS if configured door lock mechanism waste container sensors rack lights power I O Pre warm heater controller if connected and powered on remote alarm robot and reader extractor motor is engaged disengaged robot is initialized any fluid detected in tips is dispensed into waste and any tips found are then dispensed into waste plate seal tool is released if it is detected puncture tool is released if it is detected reader is initialized the GUI is loaded and preexisting alerts are displayed instrument door is unlocked The instrument reports any problems to the user through alerts If any files are missing or corrupted which would prevent proper operation of the instrument the startup process is aborted If not the user interface loads automatically Afterwards the instrument awaits the initiation of a run BD recommends that the instrument be powered on at all times except during certain maintenance procedures as recommended 500005363 02 2 15 BD Viper LT System User s Manual 2 16 500005363 02 3 Controls and Indicators 3 4 General This section describes the meaning and use of the controls and indicators of the BD Viper LT instru ment The overall l
202. te Touchscreen Section 6 2 4 6 Magnet QC Section 6 2 4 7 Pre warm Heater QC Section 6 2 4 8 e Prime Heater QC Section 6 2 4 9 e Reader QC Section 6 2 4 10 e Robot QC Section 6 2 4 11 Volume QC Section 6 2 4 12 e Clean Barcode Scanner Window Section 6 2 4 13 e Accessing the Cable I O Panel Section 6 2 4 14 6 20 500005363 02 6 Maintenance 6 2 4 1 Save Data to USB Window The Save Data function enables you to save a variety of data to USB flash or other removable media The following types of data can be saved System Log Database rack definitions results e Configuration When you select data for export and click the save data to USB button a progress bar appears at the bottom of the window showing the completion status of the file currently being exported The Save Data operation does not overwrite any files already on the USB flash drive See Figure 6 13 CAUTION Scan all USB flash drives with anti virus software prior to inserting them into a BD Viper LT instrument USB port To Access the Save Data function From the Main Status display tap the configuration maintenance button Tools Select the Tools tab QC From the Tools menu tap the save data to USB button Save Data to USB Buttons save data to USB abort export appears only when du export process is active 500005363 02 6 21 BD Viper LT System User s Manual
203. te s as shown on the display Amplification microwells are color coded as follows CT Qx Striped Green and Purple GC Qx Striped Yellow and Purple NOTE You must use the gray amplification microwells that are designed for the Viper LT system Any other microwells may provide erroneous results 5 Use blank microwells to completely fill the Amplification plate s so that there are no empty wells For wells corresponding to suppressed results you can use blank or assay microwells 4 10 500005363 02 4 Operation Barcode 12345 Created 09 20 13 1 32 14 PM cis Figure 4 4 Plate Layout Display 6 You can print the Plate Layout display by tapping the print button 7 Tap the exit button to return to the Tube Login display Tap the exit button again to return to the Main Status display 500005363 02 4 11 BD Viper LT System User s Manual 4 4 4 Pre warming Specimens All specimens tested on the Viper LT instrument are pre warmed WARNING DO NOT USE ANY MATERIALS WITH THE BD VIPER LT OR BD PRE WARM HEATER OTHER THAN THOSE SUPPLIED BY BD BD LIQUID BASED CYTOLOGY SPECIMEN DILU TION TUBES CAT NO 441444 CONTAIN FLAMMA BLE SUBSTANCES WHEN PREPARED AS INSTRUCTED BY THE PACKAGE INSERT WITH BD SUREPATH OR THINPREP PRESERVCYT PRESER VATIVE FLUIDS WHILE THESE MATERIALS HAVE BEEN CLEARED FOR USE WITH THE BD VIPER LT AND BD PRE WARM INSTRUMENTS FOLLOW YOUR INTERNAL POL
204. that plate on the display A new window appears that is enlarged to fill the screen with the selected plate In the zoomed view you can enter modify the microwell lot number See Figure 5 9 500005363 02 5 19 BD Viper LT System User s Manual You can print the Plate Layout display by tapping the print button To enter modify an assay lot number tap the position where the lot begins The Modify Microwell Lot window Figure 5 8 appears if the lot number can be changed at that location Not all microwell locations are eligible for changing the lot number ineligible locations do not respond when the microwell is tapped Lot Number field Scan or type in the lot number of the kit The lot number is a 7 digit numeric value Expiration Date field If you scan the lot number of the kit the expiration date is entered automatically If you typed in the lot number enter the expiration date in this field in the form yyyy mm dd where yyyy is the year mm is the numeric month and dd is the day Save button Tap to save the information The lot number is used by the system for all specimens subsequently logged in and for all specimens past the selected position until a new lot number is entered maximum of two Newly entered lot numbers are indicated by an asterisk overlaying the microwell icon Cancel button Tap to cancel entering lot number expiration information The Modify Microwell Lot window closes and you are
205. that the connection to the Pre warm heater has been lost 500005363 02 7 35 BD Viper Instrument User s Manual CORRECTIVE ACTION S Effect The Pre warm protocol is aborted Instrument continues to attempt to communicate with heater and may resolve the error if commu nication is re established Check USB cable between heater and instrument reattach if necessary Check power to heater apply power if necessary EC 21006 Pre warm heater initialization failure ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The Pre warm heater failed to initialize CORRECTIVE ACTION S Instrument may resolve the error if it determines that the Pre warm heater completes initialization Check USB cable between heater and instrument reattach if necessary Check power to heater apply power if necessary EC 22001 Key card reader not found PLEASE NOTE This function is not enabled for instruments distributed in the United States ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument was unable to detect the presence of a key card reader Key card reader cable USB cable may be detached Key card rea
206. the error The reader portion of the run in progress continues Future runs are prohibited Error may be corrected by running Magnet QC Configuration Maintenance Tools QC Func tions Magnet QC If this does not correct the problem cycle instrument power If error persists contact your local BD representative EC 12009 Extractor magnets general failure ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument was unable to detect that the extraction tray moved from or to its home position or that it was at its top position when raising the magnets CORRECTIVE ACTION S Effect During instrument initialization a system alert is generated and the instrument initialization continues The robot portion of a run in progress is aborted The reader portion of the run in progress continues Future runs are prohibited Error may be corrected by running Magnet QC Configuration Maintenance Tools QC Func tions Magnet QC If this does not correct the problem cycle instrument power If error persists contact your local BD representative 500005363 02 7 29 BD Viper Instrument User s Manual EC 12010 Magnets failed to move within time limit ALERT TYPE Persistent Cleared when a the instrument considers the error to be cl
207. the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The Pre warm heater failed to reach the designated safe temperature nominally 40 0 C after completing cooldown CORRECTIVE ACTION S Effects Pre warm protocol is aborted Rack is marked as not pre warmed Error may be corrected by running Pre warm QC Configuration Maintenance Tools QC Func tions Pre warm Heater QC If error persists contact your local BD representative EC 21004 Pre warm heater hardware failure ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The Pre warm heater has experienced a hardware failure or has detected that its temperature or temperature variance is out of spec CORRECTIVE ACTION S Effect The Pre warm protocol is aborted Rack is marked as not pre warmed Error may be corrected by running Pre warm Heater QC Configuration Maintenance gt Tools gt QC Functions Pre warm Heater QC If error persists contact your local BD representative EC 21005 Pre warm connection lost ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument has detected
208. the function or tap the No button to proceed with the QC function 500005363 02 6 43 BD Viper LT System User s Manual 5 When the function is complete the status is displayed at the right of the menu selection H pass indicator fail aborted indicator 6 If results of fail are reported contact your local BD representative for assistance 6 2 4 11 Robot QC Robot QC can be performed to clear certain system alerts There is no setup involved to perform this function Robot QC takes approximately one minute to complete To Access Robot QC From the Main Status display tap the configuration maintenance button Tools Tap the Tools tab From the Tools menu tap the QC button Qc Robot QC From the QC menu tap the Robot QC menu selection Robot QC Buttons start button abort button perform Robot QC 1 Verify that the 4 metal tips are in their stations see Figure 6 1 2 Access the Robot QC function as described above 3 Tapthe start button to initiate the QC function 4 In the confirmation window tap the Yes button to proceed or tap the No button to cancel the function If you select No you are returned to the QC menu 5 In the second confirmation window tap the Yes button after you confirm that the instrument doors are closed to proceed Tap the No button to cancel the function If you select No the function is aborted 6 44 500005363
209. tion magnets moved from their home position or that they were at their top position when raising the magnets CORRECTIVE ACTION S Effect During instrument initialization a system alert is generated and the instrument initialization continues The robot portion of a run in progress is aborted However run does not have aborted status since specimen processing did not begin due to the error The reader portion of the run in progress continues Future runs are prohibited Error may be corrected by running Magnet QC Configuration Maintenance Tools QC Func tions Magnet QC If this does not correct the problem cycle instrument power If error persists contact your local BD representative 7 28 500005363 02 7 Troubleshooting EC 12007 Magnet initialization failure ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument was unable to detect that the extraction tray moved from or to its home position or that it was at its top position when raising the magnets CORRECTIVE ACTION S Effect During instrument initialization a system alert is generated and the instrument initialization continues The robot portion of a run in progress is aborted However run does not have aborted status since specimen processing did not begin due to
210. to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window NOTE Error may self clear if instrument is able to reconnect with reader POSSIBLE CAUSE S The instrument was unable to communicate with the reader CORRECTIVE ACTION S Effect Reader portion of the run in progress is aborted Robot portion of the run is aborted unless instrument is able to reconnect with reader Future runs are prohibited NOTE You must repeat the run if any portion was aborted To correct the problem run Reader QC Configuration Maintenance gt Tools gt QC Functions gt Reader QC If this fails cycle instrument power to attempt to re establish communications with the reader EC 4002 Reader protocol error ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S Error occurs in tandem with another reader alert 7 10 500005363 02 7 Troubleshooting CORRECTIVE ACTION S Read and respond to other message s for Possible Causes and Corrective Actions EC 4003 Reader internal error ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The reader experienced an internal error Reader software may not have been updated p
211. to remain on the surface for 2 3 minutes Wipe the area with a clean towel saturated with water and allow to dry Retest the area Repeat cleaning process until negative results are obtained If the contamination does not 6 16 500005363 02 6 Maintenance resolve contact Technical Services or your local BD representative for additional information 6 2 3 2 Replacing the Plate Seal Tool Suction Cups Once per month discard the existing plate seal tool suction cups and install new ones The plate seal tools are located just to the left of the specimen rack See Figure 6 10 To remove the suction cups lift the tools up and out of their station Remove the suction cup from the metal stem by grabbing the metal stem firmly and pulling suction cup away until it is free of the stem To attach the new suction cup align the barb of the metal stem to the center of the suction cup and press on firmly Clean the suction cup after installation with an alcohol wipe Place the plate seal tools back in their station x PlatgSeal Tools above Figure 6 10 Plate Seal Tool Location 500005363 02 6 17 BD Viper LT System User s Manual 6 2 3 3 Replace Air Filter Check the air filter monthly If needed clean or replace the filter see procedure below If the instrument s environment is especially dusty you should check the filter more frequently A dirty filter can cause the instrument interior to re
212. to their stations EC 8008 Plate seal not released ALERT TYPE Persistent Cleared when a the instrument considers the error to be cleared and b the error has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument is unable to detect that the plate seal has been released CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted Robot End of Run activities are not performed The reader portion of the run in progress continues if error occurs during consumables check Future runs are prohibited 1 18 500005363 02 7 Troubleshooting NOTE You must repeat the run if any portion was aborted Error may be caused by placing plate seal with sticky side up should be down or a problem with plate seal tools If a plate seal is stuck to the plate seal tools remove the seal and discard it Inspect the tool suc tion cups If the cups appear undamaged clean them with an alcohol wipe and return them to the plate seal tool station Run Robot QC to clear the error Configuration Maintenance Tools QC Functions Robot QC Run Consumables Management Disposal Protocols to dispose of hazardous extraction mate rials Configuration Maintenance Tools Manage Consumables Empty Reagent Troughs Empty Extraction Tubes If error persists contact your local BD representative EC 8009 Plate seal tools stuck ALERT TYPE Persistent
213. tools are in place before starting a run Try cleaning the suction cups with an alcohol wipe If message recurs replace plate seal tools EC 8004 Plate seal tool missing ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window 500005363 02 1 17 BD Viper Instrument User s Manual POSSIBLE CAUSE S The instrument is unable to detect the plate seal tools plate seal step CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted Robot End of Run activities are performed Future runs are permitted NOTE You must repeat the run if any portion was aborted Make sure the plate seal tools are in place before starting a run If the error recurs frequently contact your local BD representative EC 8006 Plate seal tool dropped ALERT TYPE Self Clearing Cleared when the alert code has been acknowledged by tapping the OK button in the popup alert window POSSIBLE CAUSE S The instrument is unable to detect that the plate seal tools have been released to their station CORRECTIVE ACTION S Effect The robot portion of a run in progress is aborted Robot End of Run activities are not performed The reader portion of the run in progress continues Future runs are permitted NOTE You must repeat the run if any portion was aborted If necessary clean the plate seal tools with an alcohol wipe and return them
214. ts for all samples tested 1 3 Instrument Overview 1 3 4 BD Viper LT Instrument The BD Viper LT instrument contains the following modules a temperature control heating sub system to control temperatures for onboard heaters a robotic pipetting arm to transfer samples puncture troughs and seal the amp plate an extractor that chemically extracts DNA from samples a color LCD Liquid Crystal Display monitor with touchscreen an onboard reader to measure the amplification reaction and report results and the main computer which is responsible for instrument control self calibration and the user interface Major components are visible in Figures 1 1 and 1 2 and include Liquid Handling System The robot performs all sample transfers It features a 4 station pipettor that is used to transfer flu ids between specimen tubes extraction tubes reagent trough priming and amplification micro wells In addition to fluid transfers the robot uses a puncture tool to access the extraction reagent trough and a set of plate sealing tools to place a plate seals onto the amplification plate When at rest the robotic arm sits at the far right of the instrument interior Extractor Specimen lysis and DNA extraction take place in the Extractor Module located on the front right side of the instrument deck The extractor holds up to 48 extraction tubes in a 6 row numbers by 8 column letters layout Magnets are raised and lowered between the tubes DNA b
215. ture indicates that it was above the maximum temperature for that stage N A indicates that no temperature was reported for that stage 500005363 02 5 47 BD Viper LT System User s Manual BD Viper LT Temperature History Report e BD Page 1 10 25 2012 33212 PM imstmument VLTPPO4 V O6F Date Range 11 11 2011 1025 2012 Run Siaried Rak Pluie S C TLS CY 10 5400 515 535 10 18 2012 15251 PM 1 10161 700 52 5 52 5 10 24 2012115732 AM 2 10812 70 0 525 525 10 24 2012 229 50 PM 3 10712 70 0 525 SLS 10 24 2012 50514 PM 4 10612 52 52 5 10 25 2012 104900 AM 6 1051 52 52 5 By Hed Prud Be PR bein tooo 5 Wiuennzun Loree 1 aria Vineet Figure 5 21 Temperature History Report 5 48 500005363 02 5 Reference 5 7 4 Search by Accession Number Report The Search by Accession Number report enables you to search for an accession number or tubes with no accession number in the instrument s database If the accession or blank accession is found the associated rack information control results and sample results are shown in the window The Search by Accession Number Report does not print it only displays search results on the screen A sample Search by Accession Number Report is shown in Figure 5 22 To Access the Search by Accession Number Report From the Main Status display tap the reports menu button Search by Accession Number
216. ual Assembly e Place Text Pages in binder Binder 3 ring 1 white with overlays 3 sides 8 1 2 X 11 sheet size e Insert Binder Inserts in front cover and spine overlay pockets
217. uration The following major topics are included Instrument specifications Section 2 2 Instrument installation Section 2 3 Software setup Section 2 4 Instrument startup Section 2 5 WARNING PROTECTION PROVIDED BY THIS EQUIPMENT MAY BE IMPAIRED IF THE EQUIPMENT IS USED IN A MANNER NOT CONSISTENT WITH THE INSTRUC TIONS IN THIS MANUAL 500005363 02 BD Viper LT System User s Manual 2 2 Instrument Specifications Physical Dimensions Height 46 in 117 cm Width 51 in 130 cm Depth 36 in 91 cm Clearance 4 in 10 cm sides 8 in 20 cm rear Weight instrument Pre warm heater optional 467 8 Ib 212 2 kg Lighted Login Station Weight instrument only 445 7 10 202 2 kg Electrical Requirements Input Voltage 100 240 VAC Input Current 12 Amp Input Line Frequency 50 60 Hz Power Heat Instrument Pre warm heater lt 1800 W 1000 Btu hr when idle up to 3000 Btu hr during a run depending on ambient temperature relative humidity line voltage etc 300 BTUs hr when idle up to 2500 BTUs hr during a Pre warm protocol depending on ambient temperature relative humidity line voltage etc Environmental Requirements Operating Conditions Temperature 18 33 C 64 4 91 4 F Humidity 20 85 RH 18 33 C non condensing Noise 65 dB A 1 m Locations Level
218. ure 5 7 Plate Layout Display 5 18 Figure 5 8 Modify Microwell Lot 5 20 Figure 5 9 Plate Layout Display Zoomed 5 21 Figure 5 10 Extraction Lot Login Display 5 23 Figure 5 11 Modify Extraction Tube Lot Window 5 24 Figure 5 12 Modify Rack Display Rack 5 26 Figure 5 13 Copy Rack Display Rack 5 5 28 Figure 5 14 Delete Rack 2 5 30 Figure 5 15 Start Run Display 5 34 500005363 02 vii BD Viper LT System User s Manual Figures Figure 5 16 Start Run Display Rack 5 5 35 Figure 5 17 Run Status 5 37 Figure 5 18 Reports 5 39 Figure 5 19 Sample Tube Layout 5 41 Figure 5 20 Sample Tube Result Report 1 5 45 Figure 5 21 Temperature History 5 48 Figure 5 22 Search b
219. veton Circle Sparks Maryland 21152 USA Voice 410 316 4000 410 527 0244 Technical Service and Support 1 800 638 8663 Customer Service 1 800 675 0908 www bd com ds 500005363 02 BD Viper LT System User s Manual 11 2 500005363 02 12 Glossary and Abbreviations blank microwell Meaning Microwells with no dried reagents used as fillers for amp plates column Designated by numbers 1 6 CTQ Chlamydia trachomatis assay for use on the BD Viper systems dual dispense test Assay with 2 analytes each specimen is dispensed into two microwells e g CT GC external control Third party control that is logged in to a specimen rack tube is tested like a specimen rack results are not affected by external control s result EC Extraction Control extraction Method to separate capture and elute DNA FAM Fluorescein derivative a commonly used fluorescent dye with absorbance and emission maxima of 495 and 520 nm respectively fixed barcode scanner Barcode scanner located on the Pre warm heater reagent trough station or specimen rack station focus Active field on a display typically expressed as this field has focus GCQ Gonococcus Neisseria gonorrhoeae assay for use on the BD Viper systems 500005363 02 12 1 BD Viper LT System User s Manual Meaning Mode that allows you to load and begin processing the
220. wer interruptions including protection of entire runs a runtime of 180 360 minutes at a load of 1700VA is appropriate depending on instrument duty cycle and use in Walkaway or High Throughput mode Contact your local BD representative for additional information 4 34 500005363 02 5 Reference 5 1 General This section presents reference material on the BD Viper LT instrument user interface The following information is presented Software Tree Section 5 2 Main Status Display Section 5 3 e Rack Operations Menu Section 5 4 e Start Run Display Section 5 5 e Run Status Display Section 5 6 Reports Section 5 7 e Configuration Maintenance Section 5 8 e Instrument Alerts Display Section 5 9 500005363 02 5 1 BD Viper LT System User s Manual 5 2 Software Tree The following is a hierarchical list of all displays functions in the instrument The sections where these activities are discussed in detail are noted in parentheses Main Status Display Section 5 3 Rack Operations Menu Section 5 4 Rack Login Section 5 4 1 Plate Layout Section 5 4 1 1 Extraction Lot Login Section 5 4 1 2 Tube Layout Report Section 5 7 1 Modify Rack Section 5 4 2 Copy Rack Section 5 4 3 Delete Rack Section 5 4 4 Start Run Section 5 5 Run Status Section 5 6 Reports Section 5 7 Tube Result Report Section 5 7 2 Temperature History Report Section 5 7 3 Search by Accession Number Sect
221. with the BD Viper LT instru ment Assay availability for use on the BD Viper LT varies from region to region contact your local BD repre sentative for information on assay availability Catalog Number Assays Chlamydia trachomatis CT Q Assay GRAY AMP Reagent Pack 384 tests 442959 Neisseria gonorrhoeae GC Q Assay GRAY AMP Reagent Pack 384 tests 442842 Control Tube Set CT 24 24 441125 Specimen Collection and Processing Cap Removal Tool 441048 Caps 400 pierceable 441359 Caps 400 blue LBC 441443 Collection Kit CT QX GC Male Urethral Swab Wet 100 swabs diluent 441358 Collection Kit Q Endocervical Lesion Swab Wet 100 swabs diluent 441357 Sample Tube Assembly with Caps Q 400 441360 Urine Preservative Tube CT Q GC 100 tube pipette 441362 500005363 02 10 1 BD Viper LT System User s Manual Vaginal Specimen Transport Kit CT Q GC 100 swabs Catalog Number 441122 Instrument Related Earthquake Anchoring Kit 443322 Earthquake Anchoring Kit with Seismic Table table dims 72 W x 34 D x 27 75 28 75 H 183 cm W x 86 cm D x 70 73 cm H 441983 Filter Reader Air 443185 Heater BD Pre warm 442950 Login Station Lighted 442951 Microwell Adapter ea 443276 Plate Seal Suction Cups only 30 443275 Plate Seal Tool ea 44
222. y 5 30 500005363 02 5 Reference 5 5 Start Run Display The Start Run display enables you to initiate a run A run can be started when the following conditions exist instrument initialization is complete and the robot and reader are working there is at least one specimen rack defined and pre warmed there are no active system alerts that prevent a run from starting e fora Walkaway run the readers are not active there is not a run already in progress or in cleanup or a QC protocol in progress If no racks are defined the start run button is grayed out and cannot be selected Otherwise you can access the Start Run display When a run is initiated the following activities occur instrument checks barcode of the specimen rack in the rack station rack is in the Ongoing rack list the rack number and barcode appear at the top of the display see Figure 5 15 tap the start run button again to start the run barcode cannot be read the Rack selection window appears listing all the racks that are currently Ongoing see Figure 5 16 either a scan the rack barcode with the handheld scanner or b highlight the desired specimen rack insert it in the rack station if it is not already there and close the instrument door e tap the start run button e the extraction trough barcode is verified e instrument locks the door and displays the Solid Waste reminder message along with cou
223. y Accession Number Report 5 51 Figure 5 23 Tube Export Parameters 5 53 Figure 5 24 Tools Tab i ge e Li Red 5 56 Figure 5 25 Instrument Alerts Display showing alert text 5 58 Figure 6 1 Metal Tips Used in Maintenance 6 3 Figure 6 2 Lighted Login Station all LED indicators illuminated 6 8 Figure 6 3 Front Disconnect Tip Rack 6 10 Figure 6 4 Rear Disconnect Tip Rack 6 10 Figure 6 5 Disconnects Trough 6 11 Figure 6 6 Weekly Maintenance 6 12 Figure 6 7 Tip Adapter 1 6 13 Figure 6 8 Tip Adapters Sleeves Manually Retracted 6 13 Figure 6 9 Channel Check Square 6 14 Figure 6 10 Plate Seal Tool 6 17 Figure 6 11 Air Filter Cover Removal 6 19 Figure 6 12 Air Filter 6 19 Figure 6 13 Save Data to USB
224. year period Replaced components become the property of BD It is understood that the instrument covered by this warranty has been installed in accordance with the recommendations and instructions in the BD Viper LT System User s Manual Any damage to a BD Viper LT system resulting from the insertion or removal of cables that con nect this instrument to systems other than those approved or supplied by BD or the failure of the owner to use the instrument in accordance with the BD Viper LT System User s Manual or other wise fail to maintain reasonable care and precautions in the operation and maintenance of the sys tem will void this warranty and terminate the obligations of the manufacturer as stated herein BD shall not be obligated to provide services under this warranty to repair damage caused by 1 acts of God or other causes beyond BD s reasonable control 2 misuse abuse or negligence except to the extent caused by BD or by failure to comply with any requirement or instruction con tained in the BD Viper LT System User s Manual 3 sprinkler damage electrical surge or abnor mal power variation 4 relocation re installation repair maintenance or modification of the instrument without BD s authorization or 5 use of incompatible or unauthorized consumables with the instrument When such service is required it shall be at BD s prevailing rates for labor travel 500005363 02 8 1 BD Viper LT System User s Manual and

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