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Alcolizer Druglizer LE5 User Manual

Drug tester
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Druglizer LE5 Drug Tester
User Manual
The system is intended to be used by a trained professional to provide a first line screen. A
positive response will require confirmation by a laboratory-based reference assay like Gas
chromatography – Mass Spectrometry (GCMS) or Liquid Chromatography – Mass
Spectrometry (LC-MSMS). Neither the manufacturer, the distributor, nor the owner
accepts liability or responsibility due to any action or claim arising from the reading
produced by this instrument, whether used correctly or incorrectly.
Document status: ISSUED
Disclaimer – External Documents note to reader
Page 1 of 39
Uncontrolled document when printed
Version: 16

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Summary of Contents for Alcolizer Druglizer LE5

  • Page 1 Druglizer LE5 Drug Tester User Manual Disclaimer – External Documents note to reader The system is intended to be used by a trained professional to provide a first line screen. A positive response will require confirmation by a laboratory-based reference assay like Gas chromatography –...

  • Page 2: Table Of Contents

    Druglizer LE5 Drug Tester User Manual Contents INTRODUCTION ........................4 TEST PRINCIPLE ........................5 MATERIALS PROVIDED ....................... 5 WARNINGS AND PRECAUTIONS..................6 Cleaning Procedure ....................6 FUNCTIONAL FEATURES ..................... 7 MENU AND NAVIGATION ....................8 Records........................9 6.1.1 View Tests ......................9 6.1.2...
  • Page 3 Druglizer LE5 Drug Tester User Manual Acquiring GPS Satellites ................... 17 GPS Mode Configuration ..................18 8.2.1 GPS On ......................18 8.2.2 GPS Off ......................18 8.2.3 Unconfirmed Tests ................... 18 SET DATE AND TIME ......................19 10 BATTERY CARE AND CHARGING ..................19 11 FVC (Field Validation Cartridges) ..................

  • Page 4: Introduction

    User Manual 1 INTRODUCTION The Druglizer LE5 Drug Testing System is for the rapid oral fluid screening of drugs of abuse. The system incorporates a Druglizer LE5 Drug Tester Cartridge (Druglizer LE5 Cartridge), a Druglizer Oral Fluid Collector and a Druglizer LE5 Drug Tester instrument (Druglizer LE5, purchased separately).

  • Page 5: Test Principle

    User Manual 2 TEST PRINCIPLE The Druglizer LE5 Drug Testing System is based on a competitive lateral flow immunoassay technique where drug molecules that may be present in the oral fluid sample compete with the same drug attached to the nitrocellulose wicking membrane for limited binding sites on tagged drug specific antibodies.

  • Page 6: Warnings And Precautions

    CAUTION Failure to follow this warning may result in an “Invalid” test. While the Druglizer LE5 is a robust instrument, it does contain sensitive instrumentation and should not be subject to rough handling or become submerged in water. Do not store instrument in direct sunlight or places where extreme temperature conditions can occur.

  • Page 7: Functional Features

    Druglizer LE5 Drug Tester User Manual 5 FUNCTIONAL FEATURES Cartridge receptor USB Port Test Key LCD colour graphics display Up Key Silicon cover Down Key Charge Port Foil pouch Collector Cartridge Document status: ISSUED Page 7 of 39 Version: 16...

  • Page 8: Menu And Navigation

    Druglizer LE5 Drug Tester User Manual 6 MENU AND NAVIGATION The Up and Down buttons allow access to various sub menus. Operation of both buttons also facilitates access to the Off function. The menu structure looks as follows and the...

  • Page 9: Records

    6.2 Configuration 6.2.1 Printing The printing function enables the printing of records by connecting the Druglizer LE5 to a portable printer via Bluetooth connection. The instrument supports the Bixolon SPP- R200, POS-5802DD and WOOSIM WSP-i450 printers. For printing instructions please refer to section 7.

  • Page 10: Drug Configuration

    Druglizer LE5 Drug Tester User Manual If configured, the device can toggle between up to 5 different languages (4 non-English plus English) with the Test Key + Up Key for 2 seconds keybind. 6.2.5 Drug Configuration The Druglizer device can be configured to ignore specific drugs. Before configuration, ensure you are testing in accordance with your company’s policy.

  • Page 11: Fvc

    6.5.1 Guided Mode Guided mode is intended for new users of the instrument, as it provides step-by-step prompts on how to conduct a drug test like an experienced operator would as per Alcolizer training and AS4760:2019. This mode enables “extended logging” which will increase the test time by approximately 30 seconds.

  • Page 12: Printing And Bluetooth

    Druglizer LE5 Drug Tester User Manual 7 PRINTING AND BLUETOOTH The printing function enables the printing of records by connecting the Druglizer LE5 to a portable printer via Bluetooth connection. The instrument supports the following printer: • Bixolon SPP-R200 • POS-5802DD •...
  • Page 13 • Screen 4 is used to set up and enter the printer pin. • Screen 5 will automatically begin searching for and pairing to your printer. When the Druglizer LE5 identifies the printer, it will automatically pair with the printer. Standard Printers...

  • Page 14: Pairing With Onsite Testing Mobile App

    7.1 Pairing With OnSite Testing Mobile App 7.1.1 iOS 1. On the Druglizer LE5, open the menu and navigate to Configuration >> AlcoCONNECT >> Configure 2. On page 2, press the test key to enable connecting to the OnSite Testing app 3.
  • Page 15 6. Your Druglizer LE5 is now paired with the OnSite Testing app for iOS 7. To disconnect a Druglizer LE5 to an iPhone, you must forget the device from both the OnSite Testing app, as well as the iPhone’s Bluetooth settings.

  • Page 16: Android

    7.1.2 Android 1. On your Android device, go to the Bluetooth settings and search for nearby devices 2. On the Druglizer LE5, open the menu and navigate to Configuration >> AlcoCONNECT >> Configure 3. On page 2, press the test key to enable connecting to the OnSite Testing app 4.

  • Page 17: Gps

    Druglizer LE5 Drug Tester User Manual 8 GPS The Global Positioning System (GPS) function (if installed) enables the exact location of the instrument to be known and under certain circumstances, the location of testing to be recorded. 8.1 Acquiring GPS Satellites To acquire GPS location information, perform the following: •...

  • Page 18: Gps Mode Configuration

    Druglizer LE5 Drug Tester User Manual 8.2 GPS Mode Configuration The GPS can be configured in three different logging modes: on, off and unconfirmed. 8.2.1 GPS On In this mode GPS logging is enabled and the location of the instrument will be logged with every drug test.

  • Page 19: Set Date And Time

    The Battery Charging Port is located beneath the wrist strap bracket and facilitates connection to the battery charger included with the instrument. The Druglizer LE5 is equipped with a rechargeable Li-ION battery. As such it should not be tampered with in anyway. Should any problems occur that are related to the battery, contact your local Alcolizer Technology representative for advice.

  • Page 20: Fvc (Field Validation Cartridges)

    For instruments supplied with Field Validation Cartridges (this feature is normally disabled); The Drug modules are shipped with two sets of Field Verification Cartridges (FVC). The field verification is a process performed by users to verify their Druglizer LE5 is operating within allowable tolerances for drug testing.

  • Page 21: Operation

    Druglizer LE5 Drug Tester User Manual 11.1 Operation The FVC process is started by inserting the first cartridge in the FVC-1 set (FVC-1.1). The "Verifying" screen is displayed for several seconds, while the instrument is busy, before showing the result screen.

  • Page 22: Logging

    Records • View Tests. 11.3 Alert The Druglizer LE5 requires FVC check to be performed regularly to maintain optimum performance. The instrument by default will require FVC check every 28 days and display ‘FVC Due Soon’...

  • Page 23: Fvc Cartridge Care And Storing

    Druglizer LE5 Drug Tester User Manual When the ‘FVC Due Soon’ message period has expired, ‘FVC Due Now’ message is displayed, and the instrument will lock preventing further testing until the FVC check is completed successfully. 11.4 FVC Cartridge Care and Storing The cartridges must be stored in a cool, dry place, away from moisture and direct sunlight.

  • Page 24: Qr Assist

    12 QR Assist Some status items have a QR codes which, when scanned, will go to a help page for the asserted status item on the Alcolizer website. 13 PERFORMING A TEST For a written, more detailed guide, refer to Annex A - Druglizer Testing Procedure...
  • Page 25 Repeat collection steps until the Collector indicator changes to a BLUE that is consistent from edge to edge • Turn the Druglizer LE5 on and “Insert Cartridge” message will display. • Take the Druglizer Cartridge and insert it into the top of the LE5 Drug Reader Module.
  • Page 26 • For optimal hygiene – both in a test and for a Druglizer LE5 – ensure the sampled Collector surface is not pooled with excessive saliva. • Position the Collector in an upright position with the Collector pad facing downward.
  • Page 27 Druglizer LE5 Drug Tester User Manual Step Diagram Steps • The Druglizer LE5 will automatically detect the wetted Collector and begin analysing. • Typically, drug test analysis will appear from between 15 and 30 seconds. • Orientation alerts will help you from moving or tilting the instrument whilst it is analysing.

  • Page 28: Interpretation Of Results

    Druglizer LE5 Drug Tester User Manual 14 INTERPRETATION OF RESULTS • NEGATIVE (green) – drug concentration is zero or below the detectable level of the test. • UNCONFIRMED (red) – concentration of drug is above detectable level of the test.

  • Page 29: Service Life

    User Manual 16 SERVICE LIFE 16.1 Calibration Alerts The Druglizer LE5 requires calibration every twelve months to maintain optimum performance. The instrument will display ‘Service Life Pending’ warning message 28 days before calibration is required. The ‘Service Life Pending’ will be displayed each time the instrument is turned on until calibration is performed.

  • Page 30: Replacing Sample Module

    User Manual 16.2 Replacing Sample Module Rather than returning the instrument to Alcolizer for service, the module can be removed and sent in. This saves money and if the owner details are known and maintained with Alcolizer Technology, arrangements can be made to forward a replacement sample module prior to the calibration being overdue.
  • Page 31 Following the replacement of the sample module, send the out-of-calibration module back to Alcolizer. The instrument can be returned to Alcolizer Technology for calibration should the owner prefer prior to the number of days warning message period expiring. To arrange calibration, contact Alcolizer Technology.

  • Page 32: Drug Configuration

    Druglizer LE5 Drug Tester User Manual 17 Drug Configuration ATTENTION Before proceeding, ensure you are familiar with and testing in accordance with your company’s Drug and Alcohol policy. Remove any cartridge from the device before configuration. 17.1 Configuration To disable testing of a drug, open the Main Menu by pressing the Up and Down keys at the same time.

  • Page 33: Config Verification

    Druglizer LE5 Drug Tester User Manual 17.2 Config Verification It is possible to verify the configuration has taken affect or to view which drugs are tested for. Start by opening the Main Menu by pressing the Up and Down keys at the same time.

  • Page 34: Technical Specifications

    Druglizer LE5 Drug Tester User Manual 18 TECHNICAL SPECIFICATIONS Document status: ISSUED Page 34 of 39 Version: 16 Uncontrolled document when printed...

  • Page 35: Appendix

    Druglizer LE5 Drug Tester User Manual 19 Appendix 19.1 Annex A - Druglizer Testing Procedure STEP 1. Preparing for the test. Ensure you have a suitable area to perform the test and a flat area to lay the Druglizer while it is analysing. Check that the Druglizer has sufficient charge and that you have a box of Druglizer Cartridges, inspecting the ‘Temperature Card’...
  • Page 36 Druglizer LE5 Drug Tester User Manual STEP 5. Once the full minute has elapsed, advise the donor to raise their head, open their mouth fully and, without sucking on the collector, remove the collector from their mouth avoiding contact with their teeth.

  • Page 37: Annex B - Bluetooth Troubleshooting

    Step-by-Step Quick Fix Guide: Step 1: Check Device Compatibility: Ensure that nothing has changed and that the tablet, the app, and the Alcolizer device are all compatible with each other's Bluetooth protocols and specifications. Outdated or incompatible devices may lead to bonding issues.
  • Page 38 Tap on the device's name and select "Forget" or "Unpair." o Restart both your tablet and the third-party device. o Re-pair the devices by following the initial pairing steps provided by Alcolizer. • From the Device: o Access the device (Druglizer) configuration menu to forget the BT connection: >...

  • Page 39: Document Status: Issued

    Druglizer LE5 Drug Tester User Manual Conclusion: By following these steps, you can troubleshoot and resolve stale bonding issues between your tablet, the app hosted on it, and a third-party device. These actions help ensure a stable and reliable Bluetooth connection, enabling you to fully utilize the capabilities of your devices and maintain smooth communication.

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