Alere DDS 2 User Manual
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Alere DDS 2 User Manual

Mobile analyser
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Alere
DDS
2 Mobile Analyser
®
™
User Guide
EN

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Summary of Contents for Alere DDS 2

  • Page 1 Alere 2 Mobile Analyser ® ™ User Guide...

  • Page 2: Table Of Contents

    Using the Help Function Running a Drug Test Initiating a drug test Inserting the Alere DDS2 Test Cartridge Alere DDS2 Test Cartridge identification and verification of the expiry date Sample collection Test in progress and interpretation of results Completing the questionnaire...
  • Page 3 Main Menu Accessing Stored Results View results from memory Print results from memory Downloading results to the Alere Software Application Suite Results storage capacity Alere DDS2 Mobile Analyser Settings 10.1 Alere DDS2 Mobile Analyser language settings 10.2 Setting the date and time 10.3 Changing the volume settings...

  • Page 4: Introduction

    Intended use The Alere DDS2 Mobile Analyser is intended to be used in conjunction with the Alere DDS2 Test Kit to screen for the presence of Drugs of Abuse and/or their metabolites in oral fluid. For professional in vitro use only.

  • Page 5: Alere Dds2 Mobile Analyser Specifications

    * Operation within the temperature range of 5ºC to 35ºC will be tested at 20 to 80% RH, however due to testing limitations it is not possible to accurately control humidity below 10ºC. The Alere DDS2 Mobile Analyser is operational down to 5˚C at un-quantified relative humidity.

  • Page 6: Transport And Unpacking

    ® Transport and unpacking The The Alere DDS2 Mobile Analyser and its accessories are supplied in a convenient Carry Case, and all have been fully inspected and tested. Upon receiving the Alere DDS2 Mobile Test System, immediately inspect the contents of the case for any transportation damage or missing items (see list of accessories below).

  • Page 7: Data Handling

    „ test and can be reprinted from the archive at a later date. Test data can be exported from the analyser to the Alere Software Application Suite, when this has been „ installed on a PC. The Software Application Suite enables additional data to be added to test results (donor ID, tester ID), stores and re-prints test data, and generates and prints reports from test data.

  • Page 8: Alere Dds2 Mobile Analyser Calibration

    Maintenance and cleaning If required, the exterior of the Alere DDS2 Mobile Analyser and its accessories can be wiped with a lint free cloth or a damp cloth with mild detergent. Wipe away any spillages immediately. Do not use abrasive cloths or other material, and do not allow the unit to come into contact with any potentially corrosive substances.

  • Page 9: Warranty

    The manufacturer’s guarantee does not cover the Alere DDS2 Mobile Test Systems for loss, theft or damage caused by the user. Following the expiration of this guarantee, we recommend taking advantage of an extended warranty option for your analyser.

  • Page 10: Getting Started

    Alere™ DDS 2 Mobile Analyser User Guide | 2. Getting Started ® Getting Started Alere DDS2 Mobile Analyser at a glance Charging status light Power button LCD screen Left select key Right select key Five way navigation key Alere DDS2 Test Cartridge slot...

  • Page 11: User Interface And Symbols

    User interface and symbols The Alere DDS2 Mobile Analyser 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 analyser and alert the user to any errors that may occur during use.

  • Page 12: Control Keys

    If using the Alere 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 Alere Software Application Suite CD-ROM.

  • Page 13: Battery Power

    The number of tests that the analyser can perform from one full battery charge will vary depending on the type of Alere DDS2 Test Cartridge that is being used, the environmental conditions, the age of the analyser, whether results are printed and whether the questionnaire function is being used.

  • Page 14: Tilt Sensor

    Each foil wrapped Alere DDS2 Test Cartridge is packed with a silica gel packet. The silica beads are designed to change in colour when moist and act as an indication that the Alere DDS2 Test Kits have been stored correctly and have not been exposed to water vapour in the air. The silica packs are made from an environmentally friendly, synthetic silica indicating gel that is impregnated with a colour changing agent.

  • Page 15: Printer

    Charging the printer The printer will only charge when it is offline and connected to the Alere DDS2 Mobile Analyser via the RJ12 printer cable and when the analyser is powered by the mains. This is indicated by the printer’s green LED status light flashing every 1-2 seconds.

  • Page 16: Start-Up

    ® Start-up Important – Please read the instructions for use in full provided with the Alere DDS2 Test Kit, prior to commencing a test. Turn on the Alere DDS2 Mobile Analyser by pressing on the power button situated on the right hand side.

  • Page 17: Using The Help Function

    ® Using the Help Function The Alere DDS2 Mobile Analyser will display instructions and prompts on the screen to guide the user through the test process. When an action or user input has been completed, these screens will update automatically to lead on to the next step.

  • Page 18: Running A Drug Test

    Running a Drug Test Initiating a drug test Ensure the instructions for use insert supplied with the Alere DDS2 Test Kit has been read carefully before beginning a test. If additional guidance is required please contact Product Support. Step 1: Refer to section 4 Start-up to switch on the Alere DDS2 Mobile Analyser.

  • Page 19: Alere Dds2 Test Cartridge Identification And Verification Of The Expiry Date

    Following Alere DDS2 Test Cartridge identification and verification of the expiry date, the screen below will be displayed. For additional guidance on each step of the test process, select the help function on the Alere DDS2 Mobile Analyser screen or refer to the instructions for use insert supplied with the Alere DDS2 Test Kit. Step 1: Ask the donor to remove the Alere DDS2 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: Test In Progress And Interpretation Of Results

    Test in progress and interpretation of results When the Alere DDS2 Oral Fluid Collection Device has been inserted into Alere DDS2 Test Cartridge in the Alere DDS2 Mobile Analyser, the screen will display ‘test in progress’ and a countdown timer appear. The time it takes to analyse results depends on the type of test cartridge being used.

  • Page 21: Completing The Questionnaire

    Step 6: Selecting OK will accept the questionnaire and move on to the next screen. Printing results If the results and questionnaire (if used) have been accepted, the Alere DDS2 Mobile Analyser will give the option to print results. Step 1: If not already connected, attach the printer to the analyser (refer to section 3.1 Connecting the printer) and...

  • Page 22: Completing The Test

    At the end of testing when results have been displayed and printed (if required), the Alere DDS2 Mobile Analyser will prompt the user to remove the Alere DDS2 Test Cartridge. Do not remove the test cartridge by pulling the Alere DDS2 Oral Fluid Collection Device and do not attempt to remove the collection device from the test cartridge.

  • Page 23: Qc Tests

    How often should the QC tests be carried out? It is recommended that you carry out the QC tests once on each day that the Alere DDS2 Mobile Analyser is used. If required, the QC tests can be carried out before each drug test.

  • Page 24: Main Menu

    QC tests. See section 9 Accessing Stored Results. Main Menu The Alere DDS2 Mobile Analyser main menu screen (shown on the right below) can be reached from the default screen (shown on the left below) by pressing the left selection key.

  • Page 25: Accessing Stored Results

    The stored results screen will display the last 100 tests performed if they haven’t been downloaded to the Alere Software Application Suite. Select the test you wish to view using the five way navigation key to scroll up and down through the tests, then press the Options button using the left selection key. The most recent tests are at the top of the screen.

  • Page 26: Print Results From Memory

    Downloading results to the Alere Software Application Suite If the Alere Software Application Suite is being used, test data stored on the Alere DDS2 Mobile Analyser can be downloaded by connecting the analyser to a PC on to which the Software Application Suite has been installed.

  • Page 27: Results Storage Capacity

    Step 1 Step 2 To make more memory space available, test data can be downloaded from the analyser to the Alere Software Application Suite. Refer to section 9.3 Downloading results to the Alere Software Application Suite. If the data manager is not being used, please contact Product Support.

  • Page 28: 10 Alere Dds2 Mobile Analyser Settings

    Setting the date and time Alere DDS2 Mobile Analyser time and date are set to Greenwich Mean Time (GMT) by the manufacturer. To alter the date and time settings on the analyser, select the Analyser Settings option from the main menu, then in the analyser settings screen, select the Date/Time option.

  • Page 29: Backlight Settings

    To carry out a confirmation test, a second sample must be collected from the donor using a laboratory Alere DDS2 Test Kit. Please contact Product Support for more information of how to do this.

  • Page 30: Questionnaire

    Automatic shut down The Alere DDS2 Mobile Analyser can be set to automatically shut down after a period of inactivity to save power. The automatic shut down function can be set to on or off and the time period before shut down can be selected.

  • Page 31: 11 Using The Sd Card

    11 Using the SD Card The Alere DDS2 Mobile Analyser has a microSD card slot. Refer to section 2.1 Alere DDS2 Mobile Analyser 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 32: Updating Alere Dds2 Test Cartridge Types

    Updating Alere DDS2 Test Cartridge types To use a drug Alere DDS2 Test Cartridge on the Alere DDS2 Mobile Analyser, the test cartridge type must be installed in order that the analyser recognises the test cartridge. New test cartridge types can be added to the analyser via the Alere Software Application Suite software or via the SD card.

  • Page 33: Exporting Diagnostic Data

    11.3 Exporting diagnostic data Diagnostic data can be exported from the Alere DDS2 Mobile Analyser to an SD card, if required and instructed to by Product Support on behalf of the manufacturer. This data can be used to aide with troubleshooting of a particular issue or as part of routine monitoring of how the Alere DDS2 Mobile Test System is working.

  • Page 34: 12 Shut Down Procedure

    12.2 Automatic shut down In order to save power, the Alere DDS2 Mobile Analyser can be set to automatically shut down after a period of inactivity. Refer to section 10.7 Automatic shut down. The analyser will not turn shut down if a test is in progress or if a Alere DDS2 Test Cartridge is inserted.

  • Page 35: 13 Technical Support, Codes And Troubleshooting

    Technical support In the event of an incomplete test or Alere DDS2 Mobile Analyser issue, in most cases on screen feedback will be provided to the user to assist with diagnosis and resolution of the issue. In some cases, the analyser will report specific codes –...
  • Page 36 See section 11.2 valid. cartridge file. Updating Alere DDS2 Mobile Analyser types. The file selected is not a valid software The selected Incorrect file has been selected (firmware) file. Make sure a valid firmware file 4.4.X.X...
  • Page 37 Alere™ DDS 2 Mobile Analyser User Guide | 13. Technical Support, Codes and Troubleshooting ® Codes and Troubleshooting Code Description Possible Causes Solutions Ensure the correct testing process has been 4.6.X.X Cartridge The analyser detected the inserted followed. Dispose of used test cartridge, start appears to test cartridge as being used.

  • Page 38: 14 End Of Operational Life

    14.1 Return of components At the end of operational life, the Alere DDS2 Mobile Analyser and its electrical or electronic peripherals including the power supply units (PSUs), and printer, should be returned to the manufacturer. Please contact Alere Toxicology to make arrangements for return.
  • Page 39 Alere Toxicology. Failure to comply with this condition may result in prosecution and will void analyser warranty.

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