Abbott SoToxa ORAL FLUID User Manual
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Abbott SoToxa ORAL FLUID User Manual

Mobile analyzer
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SoToxa
™
EN
USER GUIDE
FOR FORENSIC USE ONLY

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Summary of Contents for Abbott SoToxa ORAL FLUID

  • Page 1 SoToxa ™ USER GUIDE FOR FORENSIC USE ONLY...

  • Page 2: Table Of Contents

    TA B L E O F C O N T E N T S Contents 1. Introduction Intended use Test principle SoToxa™ Mobile Analyzer specifications 1.4 Transport and unpacking 1.5 Accessories 1.6 Special features Data handling 1.8 Safety warnings and precautions Analyzer calibration 1.10 Maintenance and cleaning 1.11 Servicing...
  • Page 3 TA B L E O F C O N T E N T S 9. Operator Main Menu View last test 9.2 Analyzer summary 9.3 Print last QC result 9.4 Log out 10. Supervisor Main Menu 10.1 Test data management 10.2 Passcode management 10.3 Analyzer summary 10.4 Analyzer settings...

  • Page 4: Introduction

    1 . I N T R O D U C T I O N For forensic use only. The SoToxa™ Mobile Analyzer is intended to be used in conjunction with the SoToxa™ Test Kit for screening for the presence of Drugs of Abuse and/or their metabolites in oral fluid.

  • Page 5: Sotoxa™ Mobile Analyzer Specifications

    1 . I N T R O D U C T I O N SoToxa™ Mobile Analyzer specifications ANALYZER Dimensions (mm) L 222 × W 88 × H 61 Weight Approximately 680g Detection system Digital imaging device. Controls Test cartridge and collection device sensors. Test cartridge recognition using 2D barcodes for identifying cartridge type, ID, batch and expiry date.

  • Page 6: Accessories

    1 . I N T R O D U C T I O N Accessories The following items are supplied with the SoToxa™ Mobile Analyzer: • SoToxa™ Mobile Analyzer User Guide. • Carry Case. • Power supply unit and power cable. •...

  • Page 7: Analyzer Calibration

    Servicing The SoToxa™ Mobile Analyzer requires an annual service which must be carried out by an Abbott authorised and trained service engineer. It is important to have your analyzer serviced annually to ensure it is performing correctly. This requires the analyzer and accessories to be returned to the manufacturer or authorised servicing facility for a short period of time.

  • Page 8: Warranty

    1 . I N T R O D U C T I O N To view the date when the next service is due: Step 1: From either of the main menus (operator or supervisor), select the Analyzer Summary option. Step 2: The following screen will display the servicing status, scroll down to view the due date of the next service: Step 1 Step 2...

  • Page 9: Sotoxa™ Mobile Analyzer At A Glance

    2 . G E T T I N G S TA R T E D Getting started SoToxa™ Mobile Analyzer at a glance CHARGING STATUS LIGHT POWER BUTTON LCD SCREEN LEFT SOFT KEY RIGHT SOFT KEY FIVE WAY NAVIGATION KEY TEST CARTRIDGE SLOT RIGHT SOFT KEY POWER SUPPLY CONNECTOR...

  • Page 10: User Interface And Symbols

    2 . G E T T I N G S TA R T E D User interface and symbols The SoToxa™ Mobile Analyzer has a colour screen which will display graphics and text to guide the user through the test process, give feedback on the status of the test and the analyzer and alert the user to any errors that may occur during use.

  • Page 11: Results Display

    2 . G E T T I N G S TA R T E D Results display The SoToxa™ Mobile Analyzer is a screening device and all positive screens should be confirmed by a second test method such as GC-MS (Gas Chromatography-Mass Spectrometry) or LC-MS (Liquid Chromatography-Mass Spectrometry).

  • Page 12: Power Connection

    2 . G E T T I N G S TA R T E D Power connection The SoToxa™ Mobile Analyzer can be powered from a power outlet or by its internal batteries. To connect the analyzer to the power outlet: Step 1: Insert the AC power cable into the power supply unit.

  • Page 13: On-Screen Keyboard

    Access Levels for more information. The passcodes should not include any personal information and is specific to the analyzer in use. Step 1: Turn on the analyzer. The Abbott screen will be displayed followed by the Passcode Setup screen. Press the soft right button to proceed.

  • Page 14: Tilt Sensor

    2 . G E T T I N G S TA R T E D | 3 . P R I N T E R 2.11 Tilt sensor The SoToxa™ Mobile Analyzer should be used in a horizontal plane, and once the SoToxa™ Oral Fluid Collection Device has been inserted it must be kept as still and flat as possible throughout testing to prevent disruption to the test.

  • Page 15: Login

    Important – Please read the instructions for use in full provided with the SoToxa™ Test Kit, prior to commencing a test. Login Turn on the SoToxa™ Mobile Analyzer by pressing on the power button situated on the right hand side. The Abbott screen will be displayed as the analyzer boots up: On completion of boot up, the user will be required to enter the operator or supervisor passcode before being able to gain access to the analyzer.

  • Page 16: Operator Name/Id Entry

    If successful, the analyzer will display the Abbott screen and complete the start-up checks (see 4.4 Self tests). Please note the operator name/ID will remain the same until a new user of the analyzer logs on. The operator name/ID will be displayed in the test details, test printout and the analyzer summary screen.

  • Page 17: Initiating A Drug Test

    5 . U S E R A C C E S S L E V E L S | 6 . U S I N G T H E H E L P F U N C T I O N | 7. R U N N I N G A D R U G T E S T User Access Levels The SoToxa™...

  • Page 18: Inserting The Test Cartridge

    7. R U N N I N G A D R U G T E S T Inserting the test cartridge Step 1: Remove a new SoToxa™ Test Cartridge from the foil wrapper. The test cartridges and SoToxa™ Oral Fluid Collection Device are designed for single use only and must be disposed of after use. DO NOT re-insert a used test cartridge into the SoToxa™...

  • Page 19: Test In Progress And Interpretation Of Results

    7. R U N N I N G A D R U G T E S T Step 1: Remove the SoToxa™ Oral Fluid Collection Device from the packaging, ensuring they hold the plastic stem of the collection device, and then place it in the mouth.

  • Page 20: Completing The Questionnaire

    7. R U N N I N G A D R U G T E S T Select OK using the right soft key to move onto the next screen. On occasion prior to the Results screen being displayed you may see an additional analysis screen which is shown below. This screen may be present for a maximum of 60 seconds.

  • Page 21: Completing The Test

    7. R U N N I N G A D R U G T E S T | 8 . Q C T E S T S Completing the test At the end of testing when results have been displayed and printed (if required), the SoToxa™ Mobile Analyzer will prompt the user to remove the SoToxa™...

  • Page 22: Qc Lockout

    8 . Q C T E S T S Step 3: Once analysis of the first QC test cartridge is finished, the SoToxa™ Mobile Test System will prompt you to remove the current test cartridge and insert the other QC test cartridge. Note that if QC failed on the first cartridge, QC testing will be abandoned; see step 5. Step 3 Step 4: Following analysis of the second QC test cartridge, results of the QC test will be displayed as ‘QC Results: Pass’...
  • Page 23 9. O P E R AT O R M A I N M E N U Operator Main Menu The SoToxa™ Mobile Analyzer main menu screen reflects the user access levels; Operator or Supervisor and can be reached from the default screen by pressing the left soft key.
  • Page 24 9. O P E R AT O R M A I N M E N U Step 6: From the Test Options screen, you can view the questionnaire information by selecting View Questionnaire and pressing OK. The screen will then display the following information about the selected test (this is an example test). Step 6 Step 6 Step 7: Exit this screen to return to the Test Options screen.
  • Page 25 9. O P E R AT O R M A I N M E N U The information detailed on the screen is: SCREEN DISPLAY Serial number of the analyzer. Also stated on the label on the underside of the analyzer. Current operator The operator name/ID of the current user of the analyzer.
  • Page 26 1 0 . S U P E R V I S O R M A I N M E N U Supervisor Main Menu The SoToxa™ Mobile Analyzer main menu screen reflects the user access levels; Operator or Supervisor and can be reached from the default screen by pressing the left soft key.
  • Page 27 1 0 . S U P E R V I S O R M A I N M E N U Step 6: The results for the selected test are then displayed (this is an example test). Step 5 Step 6 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.
  • Page 28 1 0 . S U P E R V I S O R M A I N M E N U 10.1.3 Exporting results The SoToxa™ Mobile Analyzer has a microSD card slot. Refer to section 2.1 Analyzer at a glance for the location of the SD card cover panel. The SD card socket can only be accessed by unscrewing the SD card cover panel.
  • Page 29 1 0 . S U P E R V I S O R M A I N M E N U 10.1.4 Exporting diagnostics data Diagnostics data can be exported from the SoToxa™ Mobile Analyzer to an SD card, if required and instructed to by Customer Service on behalf of the manufacturer.
  • Page 30 1 0 . S U P E R V I S O R M A I N M E N U 10.2 Passcode management During the initial set up of the SoToxa™ Mobile Analyzer, the supervisor must enter passcodes for the operator and supervisor roles. If needed these can be changed or updated at a later date via the Passcode Management selection from the Supervisor menu.
  • Page 31 1 0 . S U P E R V I S O R M A I N M E N U Step 1: From the Supervisor menu screen select the Analyzer Summary option. Step 2: The Analyzer Summary screen will then be displayed. Step 1 Step 2 The information detailed on the screen is:...
  • Page 32 1 0 . S U P E R V I S O R M A I N M E N U Step 5: Select the desired firmware file and press the Enter button. Step 6: If the firmware file is valid, the analyzer will automatically update the firmware and reboot. Step 6 Step 6 10.4...
  • Page 33 1 0 . S U P E R V I S O R M A I N M E N U 10.4.3 Changing the volume settings To alter the volume setting on the SoToxa™ Mobile Analyzer, select the Analyzer Settings option from the supervisor menu, then in the Analyzer Settings screen, select the Sound Control option.
  • Page 34 1 0 . S U P E R V I S O R M A I N M E N U 10.4.6 Automatic shutdown The SoToxa™ Mobile Analyzer can be set to automatically shutdown after a period of inactivity to save power. The automatic shutdown function can be set to on or off and the time period before shutdown can be selected.
  • Page 35 1 0 . S U P E R V I S O R M A I N M E N U Step 6: If the test cartridge file is valid, the analyzer will update its test cartridge library and navigate back to the Installed Cartridges screen. The new test cartridge will now appear on the list of installed cartridges.
  • Page 36 11 . S H U T D O W N P R O C E D U R E | 12 . T E C H N I C A L S U P P O R T, C O D E S A N D T R O U B L E S H O O T I N G Shutdown Procedure 11.1 Turning the analyzer off...
  • Page 37 12 . T E C H N I C A L S U P P O R T, C O D E S A N D T R O U B L E S H O O T I N G 12.2 Codes and troubleshooting Please note, the codes listed below are examples.
  • Page 38 12 . T E C H N I C A L S U P P O R T, C O D E S A N D T R O U B L E S H O O T I N G CODES AND TROUBLESHOOTING Code Description...
  • Page 39 No electrical or electronic equipment may be disposed of in conventional domestic or commercial waste systems. Customer Service For product technical support and advice, please contact Customer Services: roadside@alere.com | abbott.com/toxicology 38 | EN S O T O X A™ M O B I L E A N A LY Z E R | U S E R G U I D E...
  • Page 40 Abbott. Failure to comply with this 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.

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