Abbott Pima ANALYSER User Manual Download

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Pima

ANALYSER

USER GUIDE

Summary of Contents for Pima ANALYSER

Page 1: ...PimaTM ANALYSER USER GUIDE EN ...

Page 2: ...nd counting principles as existing cell enumeration technologies in a compact portable and robust package Designed equally to suit the needs of the healthcare professional in the field or in the laboratory the Pima Analyser is an affordable effective and valuable point of care diagnostic tool The following cartridges can be used together with the Pima Analyser Pima CD4 test cartridges 25 individua...

Page 3: ... 8 Pima ANALYSER USER GUIDE 3 1 INTRODUCTION 2 GETTING STARTED 3 RUNNING A TEST 4 ANALYSIS MENU 5 MAIN MENU RESULTS 6 MAIN MENU SETTINGS 7 MAIN MENU POWER OFF 8 ERROR CODES TECHNICAL SUPPORT 9 ERROR WARNINGS MESSAGES ...

Page 4: ...Pima Analyser Status Lights 12 Pima Analyser Display 13 Charging the Pima Analyser 13 Charging Status Light 14 Switching On the Pima Analyser Power Status Light 15 User Interface 15 Navigation 16 3 RUNNING A TEST 16 Initiating a Test 17 Inserting the Pima Test Cartridge 18 Operator ID Entry 18 Sample ID Entry 18 Analysis in Progress 19 Analysis Complete 20 Printing Results immediately after Analys...

Page 5: ...perator ID 33 Delete an Operator ID 33 Date 34 Time 34 Service Export 35 Device Info 36 Connectivity 36 Local Network 37 7 MAIN MENU POWER OFF 37 Turning Off the Pima Analyser 38 8 ERROR CODES TECHNICAL SUPPORT 38 Error Code Window 38 Technical Support 39 Error Codes 40 9 ERROR WARNINGS MESSAGES 40 Archive Error 40 Barcode Errors 41 Entry Errors 42 Export Error 42 Power Warning 43 Power Error 43 P...

Page 6: ... venous whole blood is collected into the test cartridge which is then capped The Pima test cartridge is inserted into the Pima Analyser and the sample sealed within the cartridge is processed During the course of test processing data is recorded analyzed and interpreted using software embedded in the Pima Analyser Upon completion of the test the cartridge is removed from the Pima Analyser and a t...

Page 7: ...el User Interface 16 button keypad Languages Display English Memory data storage capacity of approx 1000 tests Operating Conditions Operating Temperature 10 40 C Altitude 0 2000 m Relative Humidity 10 95 no condensation Transport Storage Temperature 2 40 C Environment protect from direct sunlight humidity and dust Power Power Supply DC 18 V 3 5 A Mains Power 100 240 V 10 A C at 47 63 Hz Declaratio...

Page 8: ...nt needs to be shipped for repair or the like Pima Analyser Calibration The Pima Analyser is factory calibrated and does not require any further calibration and verification operations However a daily performance check using Pima Bead Standard is recommended If the Pima Analyser was transported or moved a test with the Pima Bead Standard may be run to ensure proper functionality Please refer to th...

Page 9: ...g Do not spray directly onto or inside of the instrument Do not use cleaning solutions containing chlorine bleach or organic solvents other than alcohol Follow instructions on clearance certificate included in the Pima Analyser box before shipping the instrument to a third party Components and Optional Items The following items are supplied with your Pima Analyser catalogue no 260300003 Power tran...

Page 10: ...alyser as described in this document Only insert USB Printers USB storage devices or other authorized devices into the USB ports of the Pima Analyser Do not use USB 3 0 storage devices Placement of the Pima Analyser should allow easy disconnection from mains A C power at any time To ensure proper ventilation do not cover the instrument while switched on Perform scan on USB storage devices for viru...

Page 11: ...R USER GUIDE 11 Power On 2 USB ports Both Pima USB ports are designed to be used with USB storage media USB Printers or other authorized devices only Power connector port Display Keypad Cartridge slot door Pima Analyser at a Glance ...

Page 12: ...ine Display of currently active menu or sub menu During analysis and in the result windows the name of the test is displayed here Message Lines Area to display menu items test results Pima Analyser activities and function messages 2020 11 01 PIMA CD4 Analysing 67352 time to result 11 14 11 00 Power Status Green Charging Status Yellow 2 GETTING STARTED Pima Analyser Status Lights Symbol Colour Pima...

Page 13: ... C power the yellow charging status light located on the front of the Pima Analyser will be illuminated indicating the charge state of the analyzer battery Insert the A C power cable into the power transformer Connect the power transformer to the power connector port located at the back of the Pima Analyser Connect the power cable to the corresponding A C power socket Power connector Power transfo...

Page 14: ...e press and hold the Power On button on the back of the Pima Analyser until the screen turns black and you hear a single beep confirming that the Pima Analyser is now switched off Restart the Pima Analyser as described above Refer to section 8 and 9 for details on error codes and contact your local distributor or Technical Support if necessary It is recommended to shutdown the Pima Analyser at lea...

Page 15: ...tered text MODE key to switch from numbers to letters and special characters on the keypad Text edit keys to enter numbers letters and special characters Press a number key to enter the respective number Press once to switch back and forth between numbers and letters and special characters respectively Press respective keys repeatedly until the desired character appears in the order as printed on ...

Page 16: ...ils on sample application and cartridge handling Check correct local date and time before running a test To initiate a test run and open the cartridge slot door press when prompted by the following screen The cartridge slot door opens and the Pima Analyser prompts the operator to insert a cartridge The cartridge slot door can be closed by pressing returning the operator to the Run test window If n...

Page 17: ...fer to p 40 for Barcode Error message Upon inserting the Pima test cartridge a sensor in the Pima Analyser recognizes that a cartridge has been inserted and automatically starts the analysis process by fully drawing the cartridge into the Pima Analyser and closing the cartridge slot door The display screen changes briefly to Reading cartridge at this moment Once the Pima Analyser has accepted the ...

Page 18: ...or List Sample ID Entry After entering an operator the Enter Sample window is displayed on the screen A Sample ID of up to 20 characters may be entered using the keypad Enter Sample ID and confirm with Analysis in Progress After Operator and Sample ID have been entered successfully the Analysis in Progress window appears The ID of the sample currently analysed and an estimated time to completion a...

Page 19: ...ng the Sample ID and test result Additional test related parameters can be viewed using and A Pima Test Report may be printed at this time see Printing results immediately after Analysis for details All results data is stored in the data archive Archived results can be viewed under Results in the Main Menu For details see section 5 Press to return to the initial Run test window and start the analy...

Page 20: ...indows by pressing The Print window appears and YES is selected by default Confirm with and the current result is printed Press or select NO to exit this window and return tothe Pima test result window The printing status is indicated by a progress bar Printing can be aborted at any time this window is shown on the screen Refer to section 4 on how to abort printing 2020 11 01 11 25 Sample CD3 CD4 ...

Page 21: ...R USER GUIDE 21 The Pima Test Report example shown below contains all information displayed on the result windows of the Pima Analyser After successful printing the Pima Analyser returns automatically to the Pima test result window ...

Page 22: ...s the operator to change the Operator and Sample ID as well as abort the test run Change Operator ID To change the Operator ID during the analysis select Operator from the Analysis Menu and confirm with Select a different operator from the Operator List or select New Operator to enter a new operator Any new operator will be automatically added to the Operator List Confirming the operator with will...

Page 23: ...he cartridge The following error code is displayed in the first result window Press to return to the initial Run test window and to start the next analysis To abort the export deletion or printing of results proceed in the same manner Press to open the Abort process window NO is selected by default Select YES and confirm with The Pima Analyser will abort the current process 2020 11 01 11 05 Do you...

Page 24: ...splayed by Test ID in reverse chronological order The last archived result is selected by default Use and to select a result of interest and confirm with This opens the first result window for the selected Sample ID Additional test related parameters can be viewed using and Press to return to the View Results window 5 MAIN MENU RESULTS 5 MAIN MENU RESULTS 2020 11 01 11 30 View Print Export Export ...

Page 25: ...ation If more than one result was selected the Print window appears and NO is selected by default Select YES and confirm with to print selected results from the Pima Analyser archive Press or select NO to exit this window and return to the Print Results window The printing status is indicated by a progress bar The Pima Test Report contains all information displayed on the four result windows of th...

Page 26: ...he Pima Analyser and displayed This may take up to one minute Use and to select a storage medium and confirm with In case the USB storage medium is not recognized please refer to p 42 for Export Error message In case a mobile modem is used please refer to Connectivity Pack IV Annex to Pima Analyser User Guide UG PIMA 01 2020 11 01 11 30 View Print Export Export and Delete Delete RESULTS 2020 11 01...

Page 27: ...ed and confirm with to export results onto the storage medium If only one result is selected export will start immediately after initial confirmation If more than one result was selected the Export window appears and NO is selected by default Select YES and confirm with to export selected results from the Pima Analyser archive Press or select NO to exit this window and return to the Export Results...

Page 28: ...ing status is indicated by a progress bar Exporting can be aborted at any time this window is shown on the screen Successful export is indicated by this message Remove storage medium or press or to continue 2020 11 01 11 30 Exporting results EXPORT RESULTS TOTAL 11 30 2020 11 01 Remove storage medium 2020 11 01 11 30 View Print Export Export and Delete Delete RESULTS Note The storage medium does n...

Page 29: ...display automatically returns to the Results window Delete Results from Archive To delete results select Delete from the Results window and confirm with The Delete Results window with all archived Sample IDs is displayed by Test ID in reverse chronological order Select results to be deleted as described in the section for result export 2020 11 01 11 30 View Print Export Export and Delete Delete RE...

Page 30: ...nd selected results are deleted from the Pima Analyser archive All other results remain in the archive The deleting status is indicated by a progress bar After successful deletion the display automatically returns to the Results window 2020 11 01 11 30 Do you want to delete 35 results DELETE YES NO 2020 11 01 11 30 Do you want to delete 35 results DELETE YES NO 5 MAIN MENU RESULTS ...

Page 31: ...h A list of all available settings is displayed Use and to scroll the complete list Enter an Operator ID Select Operator from the Settings List and confirm with This opens the Operator List window Select New Operator to enter a new operator into the list Confirm with Enter a new operator using the keypad and confirm with Press again to save new operator The Operator List now contains an operator C...

Page 32: ...dow opens Select Edit Operator and confirm with The Edit Operator window opens and the entry can be edited Confirm with when finished and the Edit Operator Menu is displayed Press to save edited operator Selecting Cancel and confirm with re opens the unchanged Operator List 6 MAIN MENU SETTINGS 2020 11 01 11 05 OPERATOR ID Edit Delete 11 05 2020 11 01 EDIT OPERATOR Save Cancel 11 05 2020 11 01 EDI...

Page 33: ...splayed in the Operator List Delete an Operator ID Select Delete in the Operator ID window and confirm with The operator is now deleted from the Operator List Date Select Date from the Settings List and confirm with to set the date on the Pima Analyser Use and to select the desired number and confirm with entering the year first followed by month and day Confirm the correct date with 11 05 2020 11...

Page 34: ...gs List and confirm with to export encrypted data from the last analysis or the last 10 analyses Follow the on screen instructions and proceed in similar fashion as described for Export Results from Archive 2020 11 01 11 05 Operator Date Time Service Export Device Info SETTINGS LIST Note The Service Export tool is meant to assist Technical Support in trouble shooting the Pima Analyser Service Expo...

Page 35: ...dow provides a quick overview of some important Pima Analyser characteristics Category Information Device Serial Number of the Pima Analyser Software Software version installed on the Pima Analyser Battery Current charging status of the internal battery Archive Number of results stored in the archive Connectivity Mobile modems that can be used with this Pima Analyser 2020 11 01 11 30 DEVICE SOFTWA...

Page 36: ...UG PIMA 01 or contact your local distributor 2020 11 01 11 05 Date Time Service Export Device Info Connectivity SETTINGS LIST Local Network This option is only available in combination with the respective hardware and Pima software version 0 40 0 or higher For more information about LAN connectivity please contact your local distributor 6 MAIN MENU SETTINGS 2020 11 01 11 05 Time Service Export Dev...

Page 37: ...the Pima Analyser To turn off the Pima Analyser select Power Off from the Main Menu and confirm with The Power Off window appears and as a safety measure NO is selected by default If YES was selected and confirmed with the screen will indicate that the Pima Analyser is shutting down This may take up to one minute After the shutdown sequence is completed the Pima Analyser will turn itself off the s...

Page 38: ...cks discover an error the test will be aborted automatically the cartridge ejected and an error code displayed on the screen an example is shown to the right 11 05 2020 11 01 Sample 67352 Invalid Test Error 810 _________________________________________ BACK X PRINT PIMA CD4 Technical Support For Technical Support please contact your local distributor or call the respective number for your region E...

Page 39: ...Repeat test with valid cartridge 204 Repeat test with new cartridge 205 Contact your local distributor 206 Analysis aborted by operator No further action required 207 Repeat test with new cartridge If Error persists contact your local distributor 210 220 230 Repeat test with new cartridge If Error persists contact your local distributor 211 Switch off the Pima Analyser via Main Menu and restart If...

Page 40: ...ode error window appears Press or and enter the number printed below the barcode on the cartridge pouch circled in image Press to confirm and continue The barcodes and their respective numbers carry important cartridge specific information and may differ from cartridge to cartridge 2020 11 01 11 05 FAILURE Archive full 2020 11 01 11 05 FAILURE Barcode error Pima CD4 Abbott Rapid Diagnostics Jena G...

Page 41: ...to enter Operator and Sample ID to view a test result Attempting to confirm blank entry fields for either Operator or Sample ID will trigger the following error messages Enter valid Operator and Sample ID to continue Should a new Operator ID be entered into the Operator List but an operator with the same name number already exists in the list the following window is displayed Press or and pick a d...

Page 42: ...torage medium and export results Power Warning The Warning Recharge battery window appears indicating that the Pima Analyser s integrated battery is low This warning can appear at any time even during an active analysis At this point the Pima Analyser is fully functional and the analysis can be continued It is recommended to connect the Pima Analyser to A C power before starting another analysis P...

Page 43: ...etely discharged Printer Errors Should the operator attempt to print results with no USB Printer attached to the Pima Analyser the Failure window is displayed Should the USB Printer run out of paper the following window is displayed After a new roll of paper has been inserted confirm continuation of printing with In case the error occurred during the printing of a Pima Test Report the last report ...

Page 44: ...pacity of the storage medium is reached the following window appears Press or and remove the storage medium Insert another storage medium with adequate storage capacity and try to export again If during export the storage medium is removed from the USB port the following window appears Press or re insert the storage medium and attempt to export again 9 ERROR WARNINGS MESSAGES 2020 11 01 11 05 INVA...

Page 45: ...be able to navigate through the Pima Analyser menus and to start a new test In case the error caused the Pima Analyser to stall press and hold the Power On button on the back of the analyzer until the screen turns and remains black Then restart the Pima Analyser This error message may appear during the initial booting procedure and will cause the Pima Analyser to stall Press and hold the Power On ...

Page 46: ...sufficient volume the following window is displayed Press or and the Abort Analysis window opens The operator can overrule this error message by selecting NO in the Abort Analysis window and the analysis process will continue Overruling Error 201 will be documented on the result pages 2020 11 01 11 05 FAILURE No sample detected Error 201 9 ERROR WARNINGS MESSAGES ...

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Page 48: ...1 01 2021 Abbott Rapid Diagnostics Jena GmbH Orlaweg 1 D 07743 Jena Germany www globalpointofcare abbott 2021 Abbott All rights reserved All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners ...

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