Druglizer LE5 Drug Tester User Manual

Disclaimer

The system is intended for use by trained professionals for first-line screening. Positive results require laboratory confirmation (e.g., GCMS, LC-MSMS). Alcolizer Technology, the distributor, and owner are not liable for actions arising from instrument use, whether correct or incorrect.

1. Introduction

The Druglizer LE5 Drug Testing System provides rapid oral fluid screening for drugs of abuse. It comprises the Druglizer LE5 Drug Tester Cartridge, Druglizer Oral Fluid Collector, and the Druglizer LE5 Drug Tester instrument (sold separately). It is designed for trained professionals to provide initial screening. 'Unconfirmed' results necessitate laboratory confirmation. Certified Operator Training by Alcolizer Technology is mandatory before use. The manual must be kept for the instrument's life and accessible to all operators.

Warnings:

• Use only human oral fluid.
• Results are preliminary qualitative analytical test results; 'Unconfirmed' requires lab confirmation.
• Presumptive drug presence does not indicate impairment.
• Negative results do not guarantee a drug-free sample; drugs may be present below the cutoff.
• Food, medicines, or errors may cause false results.

Storage temperature: -10°C to +60°C. Testing temperature: +15°C to +35°C.

Note: This manual applies to Druglizer LE5 with main module firmware RN-1.23.0 or later and drug test module B-3.6.0 or later.

2. Test Principle

The Druglizer LE5 uses a competitive lateral flow immunoassay. Drug molecules in oral fluid compete with drugs attached to a nitrocellulose membrane for binding sites on tagged antibodies. Gold colloid-tagged antibodies produce a red color. During testing, saliva interacts with the sample, wicking onto a conjugate pad where drugs bind to tagged antibodies. If no drug is present, the tagged antibody binds to the membrane-bound drug, forming a red line. If drug concentration exceeds the cutoff, the tagged antibody saturates and cannot bind to the membrane, reducing or eliminating the line. The instrument uses an algorithm to interpret results.

3. Materials Provided

The Druglizer LE5 package includes:

• Druglizer LE5 main module
• Druglizer LE5 drug test module
• USB cable
• Battery Chargers (240VAC and 12VDC vehicle)
• Silicon protective cover, cartridge plug, and wrist strap
• Soft shoulder bag or hard plastic carry case (optional)
• Bluetooth printer (optional)

Updated manuals and the AlcoCONNECT Toolbox are available at www.alcolizer.com/software-updates/. Cartridges are sold separately.

4. Warnings and Precautions

The Druglizer LE5 is manufactured to accepted technical principles, but improper use can lead to errors. Observe these precautions:

• For professional use only.
• Always store the instrument with the cartridge plug when not in use.
• Always transport the instrument in its carry case or bag.
• Always check battery levels before use and recharge if necessary.

Precautions for Cartridges:

• If stored in a fridge, allow pouches to reach room temperature (+15 to +35°C) before use.
• Do not open pouches until just prior to use.
• Do not use damaged or tampered pouches.
• Do not use contents after the expiration date.
• Pouch contents are for single use only.
• Handle oral fluid with care.
• Dispose of used materials according to local waste requirements.
• Do NOT insert the Oral Fluid Collector into the Cartridge until the Collector indicator shows a consistent blue color.

CAUTION

Failure to follow warnings may result in an 'Invalid' test. The Druglizer LE5 contains sensitive instrumentation and should not be subjected to rough handling or submersion in water. Do not store in direct sunlight or extreme temperatures.

4.1 Cleaning Procedure

Use appropriate Personal Protective Equipment (PPE) such as gloves, masks, and protective eyewear. Clean the instrument with a soft cloth and antibacterial spray or wipes. Turn off the instrument before cleaning. Wipe the exterior with a soft, moist cloth followed by a dry cloth. Clean the screen similarly. Do not use alcohol-based cleaners, harsh cleaning agents, abrasive pads, or chemicals.

5. Functional Features

The Druglizer LE5 features:

• USB Port: For data transfer and charging.
• Test Key: Initiates tests and navigates menus.
• Up Key / Down Key: Navigate menus and adjust settings.
• Cartridge Receptor: Slot for inserting the drug test cartridge.
• LCD Colour Graphics Display: Shows test results and menu options.
• Silicon Cover: Provides protection and grip.
• Charge Port: For connecting the battery charger.
• Foil Pouch: Contains the cartridge and collector.
• Collector: Collects the oral fluid sample.
• Cartridge: Contains the test strip.

6. Menu and Navigation

Use the Up and Down buttons to access sub-menus. The Off function is also accessible via these buttons. The menu structure is as follows:

• Main Menu:
• Records (View Tests, Print Test, Send Test)
• Configuration (Printing, Location, AlcoCONNECT, Language, Drug Configuration)
• About (Device, Cartridge, Drugs, Status, Service, FVC)
• Help
• Display Mode (Guided Mode, Expert Mode)
• Off

6.1 Records: View, print, or send logged drug test and customer verification records. Bluetooth connection is required for printing and sending.

6.2 Configuration:

• Printing: Connects to compatible Bluetooth printers (Bixolon SPP-R200, POS-5802DD, WOOSIM WSP-i450). Refer to Section 7 for instructions.
• Location: Configure GPS logging for test positions.
• AlcoCONNECT: Connects to smart devices with Alcolizer apps.
• Language: Select from English (Default), Bahasa, Chinese (Simplified/Traditional), French, German, Portuguese, Spanish, Vietnamese, Dutch.
• Drug Configuration: Set the device to ignore specific drugs. Refer to 6.2.5 for options.

6.3 About: Displays device information (model, software version, serial number, Bluetooth BLE), cartridge details (expiry date), tested drugs, device status, and service information (last/next service date, days remaining).

6.3.6 FVC: Displays FVC status (Last Complete, Next FVC Date, Days Remaining, Warning Date, Days to Warning).

6.4 Help: Provides instructions on device functions.

6.5 Display Mode:

• Guided Mode: Step-by-step prompts for new users, includes 'extended logging'.
• Expert Mode: Assumes operator familiarity, no prompts.

6.6 Off: Switches the device off.

7. Printing and Bluetooth

Connect the Druglizer LE5 to a compatible Bluetooth printer (Bixolon SPP-R200, POS-5802DD, WOOSIM WSP-i450) to print records. Ensure the printer is on. Navigate to Configuration > Printing on the instrument to establish the Bluetooth connection. Follow on-screen prompts to enable Bluetooth, set PIN length, enter PIN, and pair the printer. The device supports PIN digit lengths of 4 and PINs like 0000 or 1234, with a communication range up to 10 meters.

7.1 Pairing With OnSite Testing Mobile App

For iOS: Navigate to Configuration > AlcoCONNECT > Configure. Enable connection, then on the iOS device, open the OnSite Testing app settings and press Pairing. Select your Druglizer LE5 and enter the PIN shown on the device screen. Once paired, the screen will show 'Paired'. To disconnect, forget the device in both the app and iPhone's Bluetooth settings.

For Android: On the Android device, search for nearby devices via Bluetooth settings. On the Druglizer LE5, navigate to Configuration > AlcoCONNECT > Configure and enable connection. On the Android device, select your Druglizer LE5 from the list. Follow on-screen prompts to pair.

7.2 Bluetooth Troubleshooting: Refer to Appendix and Annex B for assistance.

8. GPS

The GPS function (if installed) records the instrument's location. To acquire GPS satellites, enter the main menu (Up + Down buttons simultaneously when 'Insert Cartridge' is displayed) and navigate to Configuration > Location > GPS Status. This feature is available for User-Admin roles.

8.1 Acquiring GPS Satellites

Select GPS Status to view information like Fix Status, Date/Time (UTC), Latitude, Longitude, GNSS Logging, and Signal Quality.

8.2 GPS Mode Configuration

GPS can be configured in three modes:

• GPS On: Logs location with every drug test. 'Location Unavailable' is logged if a fix cannot be obtained. The GPS logo appears in the status bar (red when acquired, grey otherwise).
• GPS Off: GPS logging is disabled; location is not recorded.
• Unconfirmed Tests: Logs location only if at least one drug tested has an unconfirmed result.

9. Set Date and Time

Refer to the AlcoCONNECT Toolbox User Manual.

10. Battery Care and Charging

The rechargeable Li-ION battery is charged via the port under the wrist strap bracket. Use only the supplied Alcolizer Technology charger. Do not tamper with the battery; contact Alcolizer Technology for issues. Battery status is shown on the display (red icon indicates charging). Power consumption occurs even in standby. Follow these charging and storage instructions:

• Check battery levels before use and recharge as needed.
• Avoid deep discharge to maintain battery efficiency.
• Avoid storage at temperatures below 0°C.
• Disconnect the device and printer from power before use.

A fully charged battery displays five green bars.

11. FVC (Field Validation Cartridges)

The FVC feature (usually disabled) uses two sets of cartridges for field verification to ensure the Druglizer LE5 operates within tolerances. The process involves inserting cartridges sequentially, following on-screen instructions. A successful FVC check takes approximately 30 seconds.

11.1 Operation

Start by inserting the first cartridge (FVC-1.1). The 'Verifying' screen appears, followed by the result. Progress is shown for each cartridge. If all cartridges pass, the device returns to idle. If a cartridge fails, the instrument displays the status, and the device may lock on failure. The FVC check can be repeated multiple times.

11.2 Logging

FVC process results (pass/fail) are logged as FVC records, viewable under Records > View Tests.

11.3 Alert

The Druglizer LE5 requires regular FVC checks for optimal performance. By default, it prompts an FVC check every 28 days, displaying a 'FVC Due Soon' warning 7 days prior. This message appears on startup until the check is performed. Pressing the Test Key dismisses the message. If the 'FVC Due Soon' period expires, 'FVC Due Now' is displayed, and testing is locked until the check is completed.

11.4 FVC Cartridge Care and Storing

Store cartridges in a cool, dry place, away from moisture and direct sunlight, in a dust-free environment. Use sealed plastic bags or airtight containers. Oxidization or contamination of the electrical contacts can affect connectivity; wipe contacts with a cloth dampened with isopropyl alcohol or use an eraser. Do not spray fluids near the cartridge. FVC cartridges are for checking only and cannot be used for drug testing; do not insert a collector into FVC cartridges.

12. QR Assist

Some status items display QR codes that link to help pages on the Alcolizer website.

13. Performing a Test

Refer to Annex A for a detailed guide. The general steps are:

1. Preparation: Ensure a suitable testing area and a flat surface for the Druglizer. Check device charge and have three new cartridges. Inspect the 'Temperature Card' in the cartridge box for heat damage. Ensure cartridge foil packaging is undamaged and sealed. Check expiry dates.
2. Donor Preparation: Ask the donor about recent food, drink, or smoking/vaping (15 minutes nil by mouth required as per AS 4760:2019). Coffee, tea, and milk can cause 'dry mouth'.
3. Saliva Collection (Initial): Instruct the donor to press the inside of their cheeks with their tongue 5 times to encourage saliva production.
4. Cartridge and Collector Handling: Tear open the pouch containing a Druglizer Cartridge and Druglizer Oral Fluid Collector. Hand the collector to the donor, ensuring nothing touches the sponge.
5. Saliva Collection (Detailed): Instruct the donor to insert the collector pad into their mouth and rub the inside of both cheeks (5 times each), then under the tongue. Place the collector on the tongue with the sponge facing down. The donor should tilt their head forward in a 'chin to chest' position. The sponge must not be chewed or sucked. The collector should remain in the mouth for at least 1 minute for sufficient saliva. Advise the donor not to worry about excess saliva or to suck/bite the sponge.
6. Collector Indicator Check: After the minute, the donor raises their head and removes the collector without touching teeth. The moisture-sensitive dot on the collector should be solid blue. If not, repeat saliva collection for 10-15 seconds. If the dot remains not blue, discard the collector, have the donor rehydrate with water, wait 15 minutes, and retest with new supplies.
7. Cartridge Insertion: Insert the collector at a 45° angle into the cartridge recess in the Druglizer, lowering it until it clicks. Press the Test Key to confirm insertion. The screen will display 'Insert Collector'.
8. Analysis Start: The instrument starts a 60-second countdown. Instruct the donor to continue collecting saliva until the timer expires. The Collector Indicator will turn solid blue when sufficient saliva is collected.
9. Instrument Positioning: The Druglizer unit must remain horizontal during analysis. Orientation alerts will sound if it is tilted. You have 20 seconds to return it to horizontal before the test aborts.
10. Analysis Process: The Druglizer will display 'Analysing' within 15-30 seconds. An increasing time counter is shown. Results for drug classes appear between 15-30 seconds, with full results typically taking 120-160 seconds.
11. Results Display: The 'Results' screen shows 'Negative' (green) or 'Unconfirmed' (red). An 'Invalid' result (grey) may indicate insufficient saliva. The 'Time Elapsed' counter is replaced by a 'Remove Cartridge' message.
12. Completion: Remove the cartridge and collector as a unit and dispose of them appropriately. The screen returns to 'Insert Cartridge'.

14. Interpretation of Results

• NEGATIVE (green): Drug concentration is zero or below the detectable level.
• UNCONFIRMED (red): Drug concentration is above the detectable level.
• INVALID (grey): Likely due to insufficient or premature saliva sampling.

15. Test Records

Records are stored and can be downloaded via AlcoCONNECT Toolbox. Periodically download and erase records. To access records: Switch on the instrument, press Up and Down buttons simultaneously to access the User Menu, navigate to Records > View Tests. Select the desired record and press the Test Key to view. The instrument automatically overwrites the oldest records when memory is full. Regular downloading is recommended.

16. Service Life

16.1 Calibration Alerts

The Druglizer LE5 requires calibration every twelve months. A 'Service Life Pending' warning appears 28 days before calibration is due. This message displays on startup until calibration. Pressing the Test Key dismisses it. If the period expires, 'Service Life Expired' is displayed, and testing is locked until calibration. Service dates can be reviewed in the 'About > Service' menu.

Users are not authorized for maintenance beyond cleaning the housing. Opening the instrument voids the warranty. Calibration and repair must be done by authorized personnel. Prevent liquid ingress; if fluid enters, switch off immediately and return to an authorized service centre.

16.2 Replacing Sample Module

The sample module can be removed and sent for service instead of the entire instrument. To replace:

1. Undo the single screw on the back of the main module.
2. Slide off the out-of-calibration sample module.
3. Slide on the new sample module.
4. Re-tighten the securing screw, ensuring it is not over-tightened.

Send the removed module back to Alcolizer. For calibration, contact Alcolizer Technology at 1300 789 908, service@alcolizer.com, or visit www.alcolizer.com.

17. Drug Configuration

ATTENTION: Ensure you are familiar with your company's Drug and Alcohol policy before proceeding. Remove any cartridge before configuration.

17.1 Configuration

To disable drug testing, open the Main Menu (Up + Down keys), navigate to Configuration > Drug Configuration. Select a configuration that ignores specific drugs (refer to 6.2.5 for details).

17.2 Config Verification

Verify configuration by navigating to Main Menu > About > Drugs. This page lists the drugs the instrument will test for.

18. Technical Specifications

Instrument Application: Law enforcement and industry.

Sensor Type: Lateral flow strips with patented Optoelectronic sensor.

Accuracy: Designed to Australian Standards AS 4760-2006.

Test Time: Results from 90 seconds.

Display: Transreflective colour graphics LCD screen.

Mouthpiece: Druglizer Oral Fluid Collector.

Calibration: Module exchange system for on-site calibration.

Power Supply: Rechargeable Li-Ion battery system.

Weight: 310g (including battery and cover).

Dimensions: 196mm H x 66mm W x 43mm D.

19. Appendix

19.1 Annex A - Druglizer Testing Procedure

Detailed steps for performing a test, including preparation, saliva collection, cartridge insertion, analysis, and result interpretation. Key points include ensuring sufficient saliva, correct collector handling, and proper instrument positioning during analysis.

19.2 Annex B – Bluetooth Troubleshooting

Provides a quick fix guide for resolving stale bonding issues between tablets, apps, and Alcolizer Bluetooth devices. Steps include checking compatibility, toggling Bluetooth, forgetting/re-pairing devices, clearing app cache, resetting network settings, and updating apps/OS. Contact IT support if issues persist.