Abbott SoToxa TOX400P User Manual Download

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USER GUIDE

EN

FOR FORENSIC USE ONLY

SoToxa

™

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Summary of Contents for SoToxa TOX400P

Page 1: ...USER GUIDE EN FOR FORENSIC USE ONLY SoToxa ...

Page 2: ...11 Silica gel packs 12 3 Printer 3 1 Connecting the printer 12 3 2 Loading paper 12 3 3 Charging the printer 12 4 Start up 13 5 Using the Help Function 13 6 Running a Drug Test 6 1 Initiating a drug test 14 6 2 Inserting the test cartridge 14 6 3 Test cartridge identification and verification of the expiry date 14 6 4 Sample collection 15 6 5 Test in progress and interpretation of results 15 6 6 C...

Page 3: ...ware 28 Application Suite 10 Shutdown Procedure 10 1 Turning the analyzer off 28 10 2 Automatic shutdown 28 11 Technical Support Codes and Troubleshooting 11 1 Technical support 29 11 2 Codes and troubleshooting 29 12 End of Operational Life 12 1 Return of components 31 13 Customer Service 31 ...

Page 4: ...test cartridge 1 2 3 The test cartridge is a chromatographic immunoassay This is a single use disposable cartridge that contains dried reagents and a liquid buffer solution 1 2 4 The test cartridge is inserted into the analyzer and is warmed by the analyzer to optimum testing temperature 1 2 5 Oral fluid is collected using the collection device supplied within the test kit This is a single use dis...

Page 5: ...ating temperature of the analyzer is 32 F to 104 F but tests must be run between 41 F to 95 F Test cartridges must not be at 23 F for more than 10 minutes Relative humidity 20 to 80 non condensing Storage temperature 4 F to 113 F Environment Protect the analyzer from direct sunlight humidity and dust POWER SUPPLY Mains power Input 100 240V AC 50 60Hz 1 1A Output 15V DC 3A Battery power 3 2Ah 11 1V...

Page 6: ... flat when in use User feedback on the tilt angle of the analyzer is provided on the screen If the analyzer is tilted out of the operational range the test may be abandoned Refer to section 2 8 Tilt sensor for more information The analyzer detects and monitors test cartridge temperature and uses a heating element to warm the test cartridge to optimum temperature for testing 1 7 Data handling The S...

Page 7: ...r to ensure the date and time settings are correct 1 9 Analyzer calibration The SoToxa Mobile Analyzer is factory calibrated and does not require any further calibration by the user However it is recommended to carry out a regular performance check using the quality control test cartridges provided with the SoToxa Mobile Test System see section 7 QC Tests 1 10 Maintenance and cleaning If required ...

Page 8: ... is covered by an initial 12 month manufacturer s guarantee The guarantee covers all mechanical or electrical faults and firmware or hardware failures The manufacturer s guarantee does not cover the systems for loss theft or damage caused by the user Following the expiration of this warranty we recommend taking advantage of an extended warranty option for your analyzer Please contact Customer Serv...

Page 9: ...KER SD CARD COVER PANEL RJ12 PRINTER CONNECTOR RUBBER FLAP USB CONNECTOR POWER SUPPLY CONNECTOR RESET BUTTON RIGHT SELECTION KEY CHARGING STATUS LIGHT LCD SCREEN RIGHT SELECT KEY FIVE WAY NAVIGATION KEY LEFT SELECT KEY TEST CARTRIDGE SLOT POWER BUTTON 2 Getting started 2 1 SoToxa Mobile Analyzer at a glance ...

Page 10: ... is accompanied by a beeping sound if the analyzer sound is switched on The analyzer must be returned to horizontal immediately and kept flat during testing If the analyzer is tilted beyond the acceptable range for too long this may result in a test error or damage to the analyzer Refer to section 2 8 Tilt sensor for more information Power connection symbol This symbol is shown when the internal b...

Page 11: ...ould not be used as these may be unsafe or incompatible with the analyzer If using the Software Application Suite this will need to be installed onto a PC Please refer to the Software Application Suite User Guide which can be found on the Software Application Suite CD ROM 2 5 Power connection The SoToxa Mobile Analyzer can be powered from a power outlet or by its internal batteries To connect the ...

Page 12: ...it to the power supply connector port located at the top of the analyzer Step 3 Connect to the corresponding AC power socket Upon connecting the power outlet the charging status light above the display will illuminate A red light means the battery is charging a green light indicates the battery is fully charged The charging status light will only be illuminated when connected to an electrical outl...

Page 13: ...d contact Customer Service Slight discoloration of the silica beads is normal When the majority of the beads within the pack are green the test cartridge should not be used 3 Printer 3 1 Connecting the printer To connect the SoToxa Mobile Analyzer to the printer use the RJ12 connector cable provided Attach this cable to the base of the printer and to the RJ12 printer connector on the top of the an...

Page 14: ...rature range for running a test is between 41 F to 91 F Outside of this range the following message will be displayed Allow the analyzer to reach ambient temperature before use If moving the analyzer between storage and operating environments of different temperatures or humidities this may take at least 30 minutes If climatic differences are significant allow more than 30 minutes for the analyzer...

Page 15: ...bile Analyzer or re use the collection device Step 2 Check the silica gel pack is yellow If the silica gel is green discard the test as the performance of the product may have been compromised See section 2 10 Silica gel packs for more information Step 3 Insert the test cartridge into the cartridge slot on the front of the analyzer 6 3 Test cartridge identification and verification of the expiry d...

Page 16: ...into the analyzer Gently push the collection device all the way into the test cartridge to the stop position Once the sample collection device has been inserted the analyzer should be kept in a horizontal plane remaining as still as possible throughout testing If the analyzer is tilted beyond the acceptable range this warning symbol will appear on the screen Correct the orientation of the analyzer...

Page 17: ...ll be entered following the results screen The questionnaire can be enabled or disabled by changing the analyzer settings Refer to section 8 3 6 Questionnaire for instructions on how to enable and disable the questionnaire The questions included in the questionnaire can be configured using the Software Application Suite If the Software Application Suite is not being used the analyzer will use the ...

Page 18: ...instead of printing refer to section 8 3 9 Printer port the SoToxa Mobile Analyzer will give the option to export test results instead of printing results Step 1 If not already connected attach the appropriate RJ11 cable to the analyzer and to the Host PC and ensure the host computer is ready to receive the test results from the analyzer Step 2 To export data select Yes using the left select key S...

Page 19: ...tep 2 Insert one of the two QC test cartridges the cartridge will be analysed automatically The order in which the QC test cartridges are inserted is not important as the SoToxa Mobile Analyzer is able to recognize the cartridge that has been inserted and will analyse it accordingly Step 3 Once analysis of the first QC test cartridge is finished the SoToxa Mobile Test System will prompt you to rem...

Page 20: ...elow by pressing the left selection key From this screen you can access stored results view the analyzer summary and settings and check the SoToxa Test Cartridges that are installed on the analyzer See the following sections for more details 8 1 Accessing Stored Results The SoToxa Mobile Analyzer will store test information and results which can then be viewed and printed 8 1 1 View results from m...

Page 21: ...options screen highlight and select View Results to see test results Step 6 The results for the selected test are then displayed this is an example test If an error has occurred during the test the results will not be available to view so this option will not be displayed on the test options screen 8 1 2 Print results from memory Step 1 From the test options screen highlight and select Print Befor...

Page 22: ... Level Current battery level in mV Firmware Version that is loaded on the analyzer See section 8 2 2 Updating firmware for further information Bootloader Version that is loaded on the analyzer See section 8 2 2 Updating firmware for further information Servicing Stated as either OK due soon or overdue with due soon meaning within a calendar month of the due date Next Service Due Date that the anal...

Page 23: ... process Where possible please ensure that data is backed up prior to completing the update To update SoToxa Mobile Analyzer firmware using the SD card follow these steps Step 1 Ensure that the new SD card is inserted in the analyzer before starting this procedure Step 2 From the main menu select the Analyzer Summary option Step 3 When in the Summary Screen press the Update button on the bottom le...

Page 24: ...the date and time SoToxa Mobile Analyzer time and date are set to Greenwich Mean Time GMT by the manufacturer To alter the date and time settings on the analyzer select the Analyzer Settings option from the main menu then in the analyzer settings screen select the Date Time option Use the five way navigation key to select the time and date then press OK to save the settings 8 3 3 Changing the volu...

Page 25: ...Mass Spectrometry Both of these confirmatory methods are laboratory tests Test results can be displayed on the analyzer in the following formats RESULTS DISPLAY Results Display Meaning Laboratory Confirmation Recommended Positive The drug or metabolites of the drug have been detected in the sample at levels above the cutoff Yes Negative The drug or metabolites of the drug have been detected in the...

Page 26: ...est is in progress or if a SoToxa Test Cartridge is inserted 8 3 8 Periodic QC The SoToxa Mobile Analyser can be set to enforce QC testing at a defined time intervals Select Analyzer Settings from the main menu then in the Analyzer Settings screen select Periodic QC In the Periodic QC screen use the five way navigation key to highlight the required setting and press OK to save the setting 8 3 9 Pr...

Page 27: ...ing the SD card follow these steps Step 1 Insert the SD card into the analyzer before starting this procedure Step 2 From the main menu select the Installed Cartridges option Step 3 In the installed cartridges screen press Add on the bottom left of the screen Step 4 The analyzer will display the list of files and folders carried on the inserted SD card To open a folder select the folder then press...

Page 28: ...ard follow these steps Step 1 Insert the SD card into the analyzer before starting this procedure Step 2 From the main menu select the Export Diagnostics option Step 3 A progress wheel will be displayed while the data is being exported It may take several minutes to complete as it is dependent on the number of tests completed on the analyzer Step 4 On completion of the export the main menu will be...

Page 29: ... Software Application Suite on the PC by double clicking the Software Application Suite icon Step 4 The analyzer will appear in the analyzer main menu of the Software Application Suite Click on this to connect to the analyzer Step 5 Once connected to the Software Application Suite the analyzer will display the following screen Step 6 Follow the Software Application Suite instructions Do not discon...

Page 30: ... 10 X X Cartridge analysis incomplete The test cartridge was not detected correctly Can be due to dirty optics a damaged test cartridge or a hardware fault Initiate a QC test if the QC test fails contact Customer Service If the QC tests pass complete the test 2 1 X X to 2 6 X X Cannot read barcode During the barcode analysis the analyzer has detected a fault this could be due to the cartridge barc...

Page 31: ...ridge and analyzer are within the 41 F to 95 F and start test again with a new test cartridge 4 8 X X Could not install cartridge file An issue occurred whilst storing the cartridge definition file Try to install the cartridge file again 4 11 X X Cartridge inserted unexpectedly Cartridge was inserted whilst analyzer was in a menu screen Ensure the correct testing process has been followed Remove t...

Page 32: ...cal or electronic peripherals including the power supply units PSUs and printer should be returned to the manufacturer Please contact Abbott to make arrangements for return No electrical or electronic equipment may be disposed of in conventional domestic or commercial waste systems 13 Customer Service For product technical support and advice please contact Customer Services roadside alere com abbo...

Page 33: ...s condition may result in prosecution and will void analyzer warranty Disclaimer At Abbott we believe in the constant development and improvement of our products and services We reserve the right to alter modify and upgrade our software programs instrumentation and publications without notice and without incurring liability 2019 Abbott All rights reserved All trademarks referenced are trademarks o...

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