Alcolizer Druglizer LE5 User manual

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Druglizer LE5 Drug Tester User Manual
Di
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 – 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.

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Contents
1 INTRODUCTION .................................................................................................................. 3
2 TEST PRINCIPLE .................................................................................................................. 4
3 MATERIALS PROVIDED ....................................................................................................... 4
4 WARNINGS AND PRECAUTIONS......................................................................................... 5
4.1 Cleaning Procedure ..................................................................................................... 5
5 Functional Features ........................................................................................................... 6
6 MENU AND NAVIGATION ................................................................................................... 7
6.1 Records ........................................................................................................................ 8
6.2 Configuration ............................................................................................................... 8
6.3 About ........................................................................................................................... 9
6.4 Help ............................................................................................................................. 9
6.5 Off ................................................................................................................................ 9
7 PRINTING AND BLUETOOTH .............................................................................................. 9
8 BATTERY CARE AND CHARGING ....................................................................................... 10
9 PERFORMING A TEST ....................................................................................................... 11
10 INTERPRETATION OF RESULTS ......................................................................................... 14
11 TEST RECORDS .................................................................................................................. 15
12 SERVICE LIFE ..................................................................................................................... 16
12.1 Calibration alerts ................................................................................................... 16
12.2 Replacing sample module ...................................................................................... 17
13 TECHNICAL SPECIFICATIONS ............................................................................................ 19

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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). The system is intended to be used by a trained professional to
provide a first line screen. A positive result displaying ‘Unconfirmed’ on-screen will require
confirmation by a laboratory-based reference assay like Gas chromatography – Mass
Spectrometry (GCMS) or Liquid Chromatography Mass Spectrometry (LCMS).
This document must be read carefully before using the Druglizer LE5 Drug Testing System
and Certified Operator Training provided by Alcolizer Technology must be completed before
using the Druglizer LE5 Drug Testing System. Keep the user manual available for the life of
the instrument and ensure operators have access to the user manual at all times. You must
always hand the user manual over to the subsequent instrument owner or user.
WARNING
• Only human oral fluid should be used.
• Results on the Druglizer LE5 are preliminary qualitative analytical test results. A
result displaying ‘Unconfirmed’ on-screen will require confirmation by a laboratory-
based reference assay.
• The presumptive presence of drugs is not a measure of impairment.
• A negative result may not necessarily indicate a drug free sample. Drugs may be
present below the stated cut off.
• Foods/medicines or preclinical errors may result in false results.
The Druglizer LE5 must be stored at a temperature between –10°C and +60°C. Conduct drug
screening tests at a temperature between +15°C and +35°C.
NOTE
This User Manual is applicable to the Druglizer LE5 with main module firmware version
RN 1.5.0 and drug test module or later

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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.
The antibodies are tagged with gold colloids to produce a conjugate with a red colour.
During testing, an oral fluid sample is absorbed onto the oral fluid collector pad. Chemicals
react with the saliva to remove sample interferences and a portion of this sample wicks
onto the conjugate pad where drugs in the sample react with tagged antibody specific for
that drug. The sample continues to wick by capillary forces along the nitrocellulose
membrane, onto which is attached the same drug of interest. If no drug is present in the
oral fluid sample the tagged antibody can bind to the drug bound to the nitrocellulose and a
red line is produced.
If drugs are present in the oral fluid sample at concentrations greater than the cut-off
concentration, the tagged antibody sites will be saturated with the drug and will not be able
to bind to the nitrocellulose bound drug, hence no result is produced. As the drug
concentration in the sample increases the colour intensity of the test line decreases. The
test strip is not intended to be viewed visually rather it is intended to be interrogated by a
meter. The instrument uses a sophisticated algorithm the determine the result.
3 MATERIALS PROVIDED
The Druglizer LE5 is supplied with the following:
• 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 user Manual and AlcoCONNECT Toolbox can be downloaded from
https://www.alcolizer.com/software-updates/
AlcoCONNECT Toolbox Version 1.6 or above is used to download test logs and configure the
Druglizer LE5. (For AlcoCONNECT Toolbox instructions please refer to AlcoCONNECT Toolbox
User Manual).
Cartridges are not included with the purchase of an instrument. Cartridges are sold
separately in cartons of 25 tests.

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4 WARNINGS AND PRECAUTIONS
The Druglizer LE5 has been manufactured and tested according to accepted technical
principles. However, improper use may still lead to measuring errors and misinterpretations
and the precautions should be observed:
• For professional use only.
• Always store instrument with Cartridge plug when not in use.
• Always transport the instrument in the carry case or bag.
• Always check the battery levels before use and recharge the instrument if necessary.
Precautions when working with Druglizer LE5 Cartridges:
• If storing pouches in a fridge, allow the pouch environment to reach room
temperature (+15 to +35°C) before use.
• Do not open pouch until just prior to use.
• Do not utilise a pouch if it is damaged or has been tampered with.
• Do not use contents after expiration date.
• Pouch contents are for single use only.
• Take precautions with oral fluid.
• Dispose of as part of your non-recyclable waste and as per local waste requirements.
• DO NOT insert the Oral Fluid Collector into the Cartridge until the Collector indicator
changes to an even blue colour that is a consistent from edge to edge.
4.1 Cleanin Procedure
• Operators should use the appropriate personal protective equipment (PPE) when
conducting a test – gloves, mask, protective eyewear, or full-face mask based on the
situation.
• The instrument should be cleaned with a soft cloth and antibacterial spray or anti-
bacterial wipes. It is recommended that the instrument is turned off before cleaning.
• The outside of the instrument can be cleaned by wiping it over with a soft moist
cloth followed by a soft dry cloth.
• Screen – the screen of the instrument can be cleaned by wiping it over with a soft
moist cloth followed by a soft dry cloth.
• Do not use alcohol-based cleaners.
• Do not use harsh cleaning agents, abrasive cleaning pads or chemicals.
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.

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5 Functional Features
Cartridge
receptor
Silicon
cover
Foil
pouch
Cartridge
Collector
Charge
Down Key
Up Key
LCD colour graphics
display
Test Key
USB Port

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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
navigation can be found on the bottom of the screen as shown below:
Confi ure
< Back
Ca
rtrid e
Authorisation
H
elp
Off
<
B
ack
Device
About >
Lan ua e
Metafields
AlcoCONNECT
Printin
Confi uration >
< Back
View Tests
Records >
Back
Service
Status
< Back
< Back
Send Test
Print Test

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6.1 Records
6.1.1 View Tests
This function shows a list view of all the logged drug test and customer verification records.
Each log entry users can see:
• RecordID
• Date and Time test was performed
• Overall result for the record
6.1.2 Print Test
This function enables users to print any drug test record from the list of all the logged
records. NB: Bluetooth connection between printer and device must be established prior
to usin this functionality.
6.1.3 Send Test
This function enables users to send any drug test record from the list of all the logged
records. NB: Bluetooth connection between the relevant Alcolizer app and Druglizer device
must be established prior to using this functionality.
6.2 Confi uration
6.2.1 Printin
The printing function enables the printing of records by connecting the Druglizer LE5 to a
portable printer via Bluetooth connection. The instrument supports the printer “Bixolon
SPP- R200”. For printing instructions please refer to section 7.
6.2.2 AlcoCONNECT
The AlcoCONNECT function is used to allow you to connect to smart devices that have one
of the Alcolizer apps installed on it.
6.2.3 Lan ua e
This function enables the user to choose the language on instruction among the available
options.
• English (Default)
• Bahasa
• Chinese (Simplified)
• Chinese (Traditional)
• French
• German
• Portuguese
• Spanish
• Vietnamese

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6.3 About
6.3.1 Device
Main Module:
• Model number
• Hardware revision
• software version
• serial number
Sample Module:
• Model number
• Software version
• Serial number
• Assembly number
6.3.2 Cartrid e
When a cartridge is inserted into the device the expiry date is visible on the screen. If
cartridge has expired the test will not be performed.
6.3.3 Status
This function shows the current status of the device or cartridge inserted into the device.
6.3.4 Service
The below information can be seen
• Last service date
• Next service due date
• Days remaining until service
6.4 Help
This menu provides instructions on the buttons required to perform functions on the device.
6.5 Off
This menu allows you to switch the device off.
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.
Place the Druglizer LE5 instrument next to the Bluetooth printer and then switch the printer
on. In order to establish the connection with the printer via Bluetooth, access to the
instrument set up menu is required. Navigate through Configuration to the Printing. Then
navigate down to the second screen and toggle to test button to enable Bluetooth.
• Screen 1 displays the status of the Bluetooth status.
• Screen 2 allows you to enable/disable Bluetooth.
• Screen 3 allows you to set pin length.
• Screen 4 is used to set up and enter the printer pin.

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• Screen 5 will automatically begin searching for your printer.
When the Druglizer LE5 identifies the printer, it will automatically pair with the printer.
Whenever the Druglizer LE5 instrument has a successful connection with the printer, the
Bluetooth icon will be blue. If there is no connection to the printer the Bluetooth icon will
be grey.
Standard Printers PIN Digit
Length PINs Communication Range
Bixolon SPP R200 4 0000 Up to 10 metres
8 BATTERY CARE AND CHARGING
The Battery Charging Port is located beneath the wrist strap bracket and facilitates
connection to the battery chargers included with the instrument.
The Druglizer LE5 is equipped with rechargeable Li-ION batteries. 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. Only use the battery
charger supplied with this instrument by Alcolizer Technology. Use of non Alcolizer
Technology supplied battery chargers could damage the instrument and render it
inoperative.
The battery status is indicated in the top right of the display. The icon changes to red when
the instrument is connected to the power supply and charging. A small amount of power
consumption is unavoidable even in standby mode, and this causes the batteries to slowly
discharge. Please observe the following instructions for charging of the batteries and
storage of the Druglizer LE5 and printer:
• Always check the battery levels before use and recharge the instrument if necessary.
• Avoid a deep discharge of the batteries to keep them working as efficiently as
possible.
• Avoid storage at low temperatures (< 0°C).
• Disconnect the Druglizer LE5 and the printer from the power supply before use.
When the battery is fully charged, the battery level indicator on the LCD Colour Graphics
Display will display five bars green.

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9 PERFORMING A TEST
Step
1
•
It is recommended the subject not
consume food, beverages or smoke
including vaping at least 15 minutes prior
to oral fluid (saliva) collection.
•
To encourage saliva production, instruct
the subject to press the inside of their
cheeks with the tip of their tongue four
times.
•
Tear open the pouch containing a
Druglizer Cartridge and Druglizer Oral
Fluid Collector.
2
•
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.
•
The flat area should face back while the
area with the collector recess should face
towards the front. When inserted the
screen will display “Insert Collector”.
3
•
Approximately 500uL (half a millilitre) of
saliva is required per drug test.
•
If insufficient saliva is taken, an ‘Invalid’ test
result may occur.
•
A Collector Indicator is located opposite the
Collector pad and will change to a blue
colour when sufficient saliva is taken.

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4
Firstly, instruct the subject to insert the
collector pad into their mouth then:
•
Rub on inside of both cheeks, 4 times each.
•
Collect saliva around mouth and under the
tongue.
Ensure the sponge is not chewed.
5
•
Instruct the subject to insert the Collector
into their mouth and rub the pad onto the
inside of both cheeks as well as under the
tongue and around the mouth.
•
Place collector on top of tongue, close
mouth, and tilt head in a chin to chest
motion
•
IMPORTANT: Druglizer LE5 training MUST
be undertaken in order to ascertain correct
saliva collection. Repeat collection steps
until the Collector indicator changes to a
BLUE that is consistent from edge to edge
6
•
When enough saliva is taken, the Collector
Indicator will change to a BLUE that is
consistent from edge to edge
7
•
For optimal hygiene – both in a test and for
a Druglizer LE5 – ensure the sampled
Collector surface is not pooled with
excessive saliva.

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8

Position the Collector in an upright
position with the Collector pad facing
downward.

Insert Collector into the Druglizer Cartridge
recess and with your thumb on the
indicator, gently snap backward into place.

Position the LE5 Drug Tester horizontally –
preferably on a flat surface. Orientation
alerts will help you from moving or tilting
the instrument whilst it is analysing a test
sample.
9

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.
10
•
Results are updated as they are analysed.
•
A “Time Remaining” counter is displayed.
11
•
The “Results” screen is displayed once
analysis of all drugs are complete.
•
Results displayed are either of the
following:
•
The Time Remaining counter is replaced
•
by a “Remove cartrid e” message.

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12
•
Once the Druglizer Cartridge is removed
the screen will then reset and return to the
“Insert Cartridge” message.
•
Dispose of the Cartridge and Collector
along with other non-recyclable waste.
10 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.
• INVALID (grey) – likely due to insufficient or premature saliva sampling.

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11 TEST RECORDS
Records are retained in the instrument and can be downloaded via AlcoCONNECT Toolbox.
It is recommended that records are periodically downloaded and erased from the
instrument. Access the records as follows:
• Switch the instrument on.
• Press the Up and Down buttons simultaneously.
The User Menu will be displayed.
• Navigate to Records menu and select View Tests.
Record browser will be displayed with the list of all the logged drug test and
customer verification records.
• Use the up/down to select the desired record and press the test key. Browser menu
will be displayed with an option to view record.
• Select View. Record will be shown as below:
As the instrument automatically stores records, the memory will eventually reach capacity
and the oldest record will be automatically overwritten.
Regular downloading of records using AlcoCONNECT Toolbox is recommended.

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12 SERVICE LIFE
12.1 Calibration alerts
The Druglizer LE5 requires calibration every six months to maintain optimum performance.
The instrument will display ‘Service Life Pending’ warning message 30 days before
calibration is required.
The ‘Service Life Pending’ will be displayed each time the instrument is turned on until
calibration is performed.
Press the Test Key to cancel the message and continue testing.
When the ‘Service Life Pending’ message period has expired, ‘Service Life Expired’ message
is displayed, and the instrument will lock preventing further testing until the instrument is
calibrated.
At any time, you can review the service dates.
The user is not authorized to maintain or calibrate the instrument in any way with the
exception cleaning of the instrument's housing. Any other form of maintenance must not be
carried out by the user. Opening the instrument will render any warranty claims null and
void. The instrument is factory calibrated. The instrument must only be repaired or
calibrated by authorized, qualified personnel.
The instrument may be damaged by liquid ingress. Please ensure that water and other
liquids are prevented from penetrating the instrument. If any fluid enters the internal parts
of the instrument, switch off the instrument immediately and return to authorised service
centre.

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12.2 Replacin 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.
Remove and replace the sample module as follows:
a. Undo the single screw on the back of the main module.
b. Slide off the out-of-calibration sample module.
c. Slide on the new sample module.
CAUTION
Do not over tighten the sample module securing screw as this will damage the threaded
portion. Tighten only enough to prevent the sample module from sliding away from the
main module.

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d. Do up the single screw on the back of the main module.
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. Phone: [phone]; Email: [email protected]; or Web:
www.alcolizer.com

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13 TECHNICAL SPECIFICATIONS