Alere DDS 2 User manual

EN
Alere™DDS®2 Mobile Analyser
User Guide

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Alere™ DDS®2 Mobile Analyser User Guide | Contents
Contents
1 Introduction 1
1.1 Intended use 1
1.2 Test principle 1
1.3 Alere DDS2 Mobile Analyser specifications 2
1.4 Transport and unpacking 3
1.5 Accessories 3
1.6 Special feature 3
1.7 Data handling 4
1.8 Safety warnings and precautions 4
1.9 Alere DDS2 Mobile Analyser calibration 5
1.10 Maintenance and cleaning 5
1.11 Servicing 5
1.12 Warranty 6
1.13 Drug abbreviations 6
2 Getting Started 7
2.1 Alere DDS2 Mobile Analyser at a glance 7
2.2 User interface and symbols 8
2.3 Control keys 9
2.4 Setting up 9
2.5 Mains power 9
2.6 Battery power 10
2.7 Charging the Alere DDS2 Mobile Analyser 10
2.8 Tilt sensor 11
2.9 Silica gel packs 11
3 Printer 12
3.1 Connecting the printer 12
3.2 Loading paper 12
3.3 Charging the printer 12
4 Start-up 13
5 Using the Help Function 14
6 Running a Drug Test 15
6.1 Initiating a drug test 15
6.2 Inserting the Alere DDS2 Test Cartridge 15
6.3 Alere DDS2 Test Cartridge identification and verification of the expiry date 16
6.4 Sample collection 16
6.5 Test in progress and interpretation of results 17
6.6 Completing the questionnaire 18
6.7 Printing results 18
6.8 Completing the test 19

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Alere™ DDS®2 Mobile Analyser User Guide | Contents
7 QC Tests 20
7.1 What are the QC tests? 20
7.2 How often should the QC tests be carried out? 20
7.3 Running the QC tests 20
8 Main Menu 21
9 Accessing Stored Results 22
9.1 View results from memory 22
9.2 Print results from memory 23
9.3 Downloading results to the Alere Software Application Suite 23
9.4 Results storage capacity 24
10 Alere DDS2 Mobile Analyser Settings 25
10.1 Alere DDS2 Mobile Analyser language settings 25
10.2 Setting the date and time 25
10.3 Changing the volume settings 25
10.4 Backlight settings 26
10.5 Results display 26
10.6 Questionnaire 27
10.7 Automatic shut down 27
11 Using the SD Card 28
11.1 Updating firmware 28
11.2 Updating Alere DDS2 Test Cartridge types 29
11.3 Exporting diagnostic data 30
12 Shut Down Procedure 31
12.1 Turning the Alere DDS2 Mobile Analyser off 31
12.2 Automatic shut down 31
13 Technical Support, Codes and Troubleshooting 32
13.1 Technical support 32
13.2 Codes and troubleshooting 32
14 End of Operational Life 35
14.1 Return of components 35
15 Product Support 35

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Alere™ DDS®2 Mobile Analyser User Guide | 1. Introduction
The Alere™ DDS®2 Mobile Analyser is intended to be used in conjunction with the Alere™ DDS®2 Test Kit for
screening for the presence of Drugs of Abuse and/or their metabolites in oral fluid. For professional in vitro use only.
A positive test result should be confirmed by a second test method such as GCMS (gas chromatography-
mass spectrometry) or LCMS (liquid chromatography-mass spectrometry).
Please read this user guide and the test kit instructions for use carefully, prior to using the analyser.
DDS2-400-P | DDS2-400-S-UK | DDS2-400-S-AUS | DDS2-400-S-US | DDS2-400-S-EU
1.1 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.
A positive test result should be confirmed by a second test method such as GCMS (gas chromatography –
mass spectrometry) or LCMS (liquid chromatography – mass spectrometry).
1.2 Test principle
1.2.1 The Alere DDS2 Mobile Test System consists of the analyser, and the Alere DDS2 Test Kits which contain the
Alere DDS2 Test Cartridge and the Alere DDS2 Oral Fluid Collection Device.
1.2.2 The analyser is a digital imaging device which uses advanced image processing algorithms to accurately
determine the line intensity on the test cartridge.
1.2.3 The test cartridge is a chromatographic immunoassay. This is a single use, disposable test cartridge that
contains dried reagents and a liquid buffer solution.
1.2.4 The test cartridge is inserted into the analyser and is warmed by the analyser to optimum testing temperature.
1.2.5 Oral fluid is collected using the collection device supplied within the test kit. This is a single use, disposable
collection device. The donor must actively swab the collection device around the gums, tongue and inside
the cheek, until the sample presence indicator starts to turn blue.
1.2.6 The collection device is then inserted into the test cartridge.
1.2.7 During the testing process, the oral fluid is combined with a buffer solution, mixed and then incubated before
being applied to the immunoassay test strips housed within the test cartridge.
1.2.8 The oral fluid flows by capillary action along the test strips, carrying with it labelled anti-drug antibody which
is released from pads on the strips and in the sample reservoir.
1.2.9 At designated zones on the strips, drug protein conjugate has been applied in bands which are invisible to
the human eye. In the absence of a drug in the sample, the anti-drug antibody will bind to the drug protein
conjugate to form a line. In the presence of a drug the formation of this complex will be diminished, forming
a weaker line.
1.2.10 On receipt of the analyser by the user, the analyser is already configured by the manufacturer to read specific
test cartridge types. Additional test cartridge types can be added by the user by application of test cartridge
updates (see section 11.2 Updating Alere DDS2 Mobile Analyser types).
1.2.11 The analyser ‘reads’ the line intensity on the test strips. The detected line intensity is compared with a
predetermined threshold derived from equivalent concentration curves, to report qualitative results.
1.2.12 Test results are displayed on the analyser screen and can be printed using the printer.
1.2.13 The test cartridge is then removed from the analyser and disposed of in accordance with local and
national regulations.
1 Introduction

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Alere™ DDS®2 Mobile Analyser User Guide | 1. Introduction
1.3 Alere DDS2 Mobile Analyser specifications
Alere DDS2 Mobile Analyser
Dimensions (mm) L 222 x W 88 x H 61
Weight Approximately 680g
Detection system Digital imaging device
Controls Alere DDS2 Test Cartridge and Alere DDS2 Oral Fluid Collection Device sensors. Test
cartridge recognition using 2D barcodes for identifying test cartridge type, ID, batch and
expiry date. Sensor providing feedback on angle of inclination of analyser. Test cartridge
heating with temperature control. Internal start-up checks and process controls during
testing. Quality control test cartridges
Display LCD colour screen 3.2ʺ
User interface Five way navigation key, left and right select keys, power button, reset button
Electrical rating 15V 3A (via external PSU).The reader is only charged/powered by the supplied PSU and cables
Languages
English, Spanish, Italian, German, Croatian, Turkish, Portuguese, Russian, Slovakian,
Czech, Dutch, French, Polish, Vietnamese, Greek, Danish, Swedish, Indonesian, Finnish
and Norwegian
Memory Data storage capacity of over 10,000 tests
SD card SD card connectivity for firmware and test cartridge updates and export of diagnostic data
USB Interface To communicate with the Alere Software Application Suite if required
Printer Connection to Martel MCP7810-323 printer for printing test reports
Operating Conditions
Temperature 5°C to 35°C* This is the operational temperature for running a test.
Note: the rated safe electrical operating temperature of the reader is 0°C to 40°C,
but tests must be run between 5°C to 35°C. Test cartridges must not be at -5°C for
more than 10 minutes
Relative humidity 20 to 80% non-condensing
Storage temperature -20°C to 45°C
Environment Protect the analyser from direct sunlight, humidity and dust
Power Supply
Mains power Input: 100-240V AC 50-60Hz 1.1A | Output: 15V DC 3A
Battery power 4.7Ah 7.4V lithium polymer battery
Car (optional) Input: 10 to 15V DC | Output: 15V DC 3A
Printer
Dimensions (mm) L 150 x W 80 x H 50
Weight 363.5g
Controls Power button
* 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.

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Alere™ DDS®2 Mobile Analyser User Guide | 1. Introduction
1.4 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). If any sign of damage is found, or if any items are missing, contact your distributor or Product
Support immediately.
The case is designed to allow the analyser and accessories to be used from within the case, however the
analyser can be removed if required. It is recommended that the analyser is operated and transported in the
case, and is secured by the Velcro straps to prevent movement when in transit.
1.5 Accessories
The following items are supplied with the Alere DDS2 Mobile Analyser:
Alere DDS2 Mobile Analyser User Guide CD-ROM.
Carry Case.
Power supply unit and power cable.
Micro USB cable for connection to a PC if Alere Software Application Suite is used.
QC Alere DDS2 Test Cartridge set.
Printer and RJ12 printer cable.
The following optional items may also be supplied with your analyser:
Alere Software Application Suite CD-ROM.
Alere DDS2 car power supply.
The following item may be required, but is not supplied with the Alere DDS2 Mobile Test System:
Small Phillips head screwdriver. This tool is required to access the SD card. Refer to section 11 Using the
SD Card.
1.6 Special feature
The Alere DDS2 Mobile Analyser guides the user through the testing process with a series of on-screen
messages and prompts and also has an on-board ‘Help’ function providing on the spot support if required.
The analyser automatically performs a series of start-up checks on start up along with process controls
during testing to ensure correct operation. The analyser will not allow a test to be carried out or continued
if a malfunction is detected.
The analyser is provided with a positive and negative quality control Alere DDS2 Test Cartridge (PQC and
NQC). It is recommended that these performance checks are carried out at least once on each day of
testing. Please refer to section 7 QC Tests, for further information.
The analyser has internal sensors to detect the presence and position of the test cartridge and Alere DDS2
Oral Fluid Collection Device. If the test cartridge and collection device are not detected, are detected at the
wrong time in the test protocol, or are removed from the analyser prematurely, the test may be abandoned.
The analyser reads and stores test cartridge information from the test cartridge barcode.
If the test cartridge has expired, the test will not be continued.
New test cartridge types must be installed on the analyser via the SD card or the Alere Software
Application Suite before use. Updates will be provided by the manufacturer.
The analyser should be positioned horizontally and kept flat when in use. User feedback on the tilt angle of
the analyser is provided on the screen. If the analyser is tilted out of the operational range, the test may be
abandoned. Refer to section 2.8 Tilt sensor for more information.
The analyser detects and monitors test cartridge temperature and uses a heating element to warm the test
cartridge to optimum temperature for testing.

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Alere™ DDS®2 Mobile Analyser User Guide | 1. Introduction
1.7 Data handling
The Alere DDS2 Mobile Analyser is capable of data entry (donor questionnaire), Alere DDS2 Test
Cartridge identification via the test cartridge barcode, storage of test data and connectivity to the printer,
PC and SD card.
All results are stored in an on-board archive and may be retrieved and viewed on the analyser
at any time after the test.
Test results can be printed using the printer. Results can be printed immediately following the
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.
Firmware upgrades and new test cartridge configurations can be uploaded to the analyser from an
SD card, when these are released by the manufacturer.
When test data is downloaded to the Software Application Suite it is automatically deleted from
the analyser.
1.8 Safety warnings and precautions
WARNING: The Alere DDS2 Mobile Analyser and Alere DDS2 Test Cartridges generate a weak magnetic
field, which may interfere with the operation of cardiac implant devices such as pacemakers. Always
maintain a safe distance of separation between the Alere DDS2 Mobile Test System and any implanted
device. If you feel unwell whilst using the system, stop using the system and consult your physician.
Only use the power supply unit (PSU), printer, USB and other associated cables supplied with the analyser
as described in this user guide. If any part of the equipment is used in a manner not specified by the
manufacturer, the protection provided by the equipment may be impaired. Contact Product Support if in
any doubt regarding power supplies and cables for use with the system.
Please ensure that the mains supply cable for the power supply unit is appropriately rated and approved
as per the applicable national requirements.
As with any electrical instrument or equipment care is required when handling the analyser to ensure that
it is not subjected to heavy shocks or dropped from any height. Never exert undue force on the surface of
the display, or expose any part of the analyser to sharp or abrasive objects.
Use the analyser indoors when connected to A/C power.
Do not open the analyser. The analyser contains no user serviceable parts. Any unauthorised opening of
the analyser can cause hazards and will invalidate warranty claims.
It is highly recommended that all PC’s supporting the Alere Software Application Suite (if used) carry up to
date antivirus software.
The test cartridges are designed for single use only – do not attempt to re-insert a used test cartridge into
the analyser.
Do not insert fingers or objects other than the test cartridge into the test cartridge slot. This may result in
harm to the user or damage to the analyser.
Do not use dirty or damaged test/QC cartridges as this may damage the analyser or cause an invalid
test result.
Do not use the analyser or any of its electrical accessories if these appear to be damaged. Contact
Product Support to arrange for replacement parts.
Do not use the analyser near a magnetic source.
Do not ingest the silica gel packs.
Do not open power supply casing or printer.
Allow the analyser to reach ambient temperature before use. If moving the analyser between storage
and operating environments of different temperatures or humidities, this may take at least 30 minutes.
If climatic differences are significant, allow more than 30 minutes for the analyser to acclimatise. It is the
responsibility of the user to ensure the date and time settings are correct.

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Alere™ DDS®2 Mobile Analyser User Guide | 1. Introduction
1.9 Alere DDS2 Mobile Analyser calibration
The Alere DDS2 Mobile Analyser is factory calibrated and does not require any further calibration by the user.
However, it is recommended to carry out a regular performance check using the quality control Alere DDS2
Test Cartridges provided with the Alere DDS2 Mobile Test System (see section 7 QC Tests).
1.10 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. If
using a damp cloth, ensure the analyser is turned off and disconnected from mains A/C power.
DO NOT try to clean inside the analyser or open the analyser for cleaning.
The analyser does not contain any user serviceable components. If a fault is suspected or routine factory
maintenance is required, then please contact your distributor or Product Support.
1.11 Servicing
The Alere DDS2 Mobile Analyser requires an annual service which must be carried out by a qualified service
engineer. It is important to have your analyser serviced annually to ensure it is performing correctly. This
requires the analyser and accessories to be returned to the manufacturer or authorised servicing facility for a
short period of time.
The date that the next service is next due can be viewed in the analyser summary screen, and the analyser
will automatically display the service symbol in the status line when service is due in less than one month.
If the analyser is not returned to the manufacturer for servicing within this time, the symbol will turn from
white to orange.
Service status (OK, due or overdue) will be displayed in the test details for each test and will also be printed
on test printouts.
Accuracy of tests carried out on an analyser which is overdue a service, may be reduced. Failure to return
the analyser for annual service will invalidate warranty claims.
To view the date when the next service is due:
Step 1: From the main menu, select the Analyser Summary option.
Step 2: The following screen will display the servicing status, scroll down to view the due date of the next service:
Please contact your distributor or Product Support to arrange servicing when required. The analyser and
accessories must be returned in the Carry Case for protection in transit.
Step 1 Step 2

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Alere™ DDS®2 Mobile Analyser User Guide | 1. Introduction
1.12 Warranty
The Alere DDS2 Mobile Analyser is covered by an initial 12 month manufacturer’s guarantee. The guarantee
covers all mechanical or electrical faults and firmware or hardware failures. 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. Please contact your distributor or Product Support for details.
1.13 Drug abbreviations
Drug Abbreviations
Abbreviation Drug Name
AMP Amphetamine
BZO Benzodiazepines
COC Cocaine
MAMP Methamphetamine
MTD Methadone
OPI Opiates
THC Cannabis

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Alere™ DDS®2 Mobile Analyser User Guide | 2. Getting Started
2 Getting Started
Five way navigation key
Left selection key
Speaker
SD card cover panel
RJ12 printer connector
Rubber flap
USB connector
Power supply connector
Reset button
Right selection key
Charging status light
LCD screen
Right select key
Five way navigation key
Left select key
Alere DDS2 Test Cartridge slot
Power button
2.1 Alere DDS2 Mobile Analyser at a glance

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Alere™ DDS®2 Mobile Analyser User Guide | 2. Getting Started
2.2 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. The analyser also has a speaker and will produce various sounds as alerts
or to tell the user when a test is complete. See section 10 Analyser Settings, for more information on how to
alter the screen backlight and volume settings of the analyser.
The analyser screen displays date and time at all times. You will also see symbols appearing on the screen
from time to time giving more information on the status of the analyser. These symbols will be displayed in
the status line at the top of the screen, alongside the date and time.
The symbols used by the analyser and their meaning, are shown below:
Alere DDS2 Mobile Analyser Symbols
Symbol Meaning
Memory symbol (white): The appearance of this symbol indicates that the analyser is close to
reaching maximum storage capacity for stored test results. Refer to section 9.3 Downloading results
to the Alere Software Application Suite for instructions on how to download test data to make
more memory space available. To view how much memory space is remaining, refer to section 9.4
Results storage capacity.
Memory symbol (orange): When memory storage capacity is reached, the white memory
symbol will turn orange. The oldest tests stored on the analyser will be overwritten with new
test results. To back up stored test data and make more space available, refer to section 9.3
Downloading results to the Alere Software Application Suite. If the Software Application Suite is
not being used, please contact Product Support for advice.
Tilt warning symbol: The appearance of this symbol means that the analyser has been tilted
beyond the acceptable range for testing. This symbol is accompanied by a beeping sound (if the
analyser sound is switched on). The analyser must be returned to horizontal immediately and kept
flat during testing. If the analyser is tilted beyond the acceptable range for too long, this may results
in a test error or damage to the analyser. Refer to section 2.8 Tilt sensor for more information.
Mains connected symbol: This symbol will appear when the analyser is connected to the
mains power via the power cable. If this symbol does not appear when connected to the
mains, check that the power cable connections are secure and that the mains power is on. If
the analyser is charging from the mains power, the battery charging symbol will be displayed.
When charging is complete, the mains connected symbol will appear. Refer to section 2.5 Mains
power for more information.
Battery status symbol: This symbol is displayed to show that the analyser is operating from
battery, rather than the mains power. If the analyser is not connected to the mains, the battery
status symbol will be displayed. The level of battery power remaining is indicated by the number
of shaded blocks. When all the blocks are shaded, the battery is full.
Critical battery level: The battery status symbol will change to a red outline with the last block
shaded red when the battery reaches a critical level. The analyser will need to be connected to
the mains power and charged.
Battery charging symbol: This is the same symbol as the battery status symbol but the number of
shaded blocks will increase and decrease to indicate charging. This symbol will be displayed when
the analyser is connected to the mains power and is charging. The analyser will automatically begin
to charge when connected to the mains power, if the battery is not full. Once the battery is charged,
this symbol will be replaced by the mains connected symbol. Refer to section 2.7 Charging the
analyser for more information.

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Alere™ DDS®2 Mobile Analyser User Guide | 2. Getting Started
Alere DDS2 Mobile Analyser Symbols
Symbol Meaning
Service symbol (white): This symbol will appear on the status line when the annual service date
for the analyser is due in less than one month. To view the service due date, refer to section 1.11
Servicing. Contact Product Support to arrange a service for the Alere DDS2 Mobile Test System.
Service symbol (orange): When service is overdue, the service symbol will turn orange.
Contact Product Support to arrange a service for the Alere DDS2 Mobile Test System. Accuracy
of test results may be reduced if a service is overdue.
2.3 Control keys
The Alere DDS2 Mobile Analyser has three control keys: the left selection key, the right selection key and
the five way navigation button. Please see section 2.1 Alere DDS2 Mobile Analyser at a glance, which
shows the location of these buttons.
The left and right selection keys can be used to select the corresponding on-screen buttons which will
appear at the bottom left and right hand corners of the screen when input is required from the user. For
example, if the screen below appears, pressing the left selection key would take the user to the menu while
pressing the right selection key would take the user to the help function associated with this step.
The five way navigation key can be used to scroll up, down, left and right by pressing the top, bottom, left or
right edge of the button respectively. For example, if the screen below appears, the five way navigation key
can be used to move the highlighter bar up and down through the list of test results. Pressing the centre of
the five way navigation key selects the option that is highlighted on the screen and can be used instead of
the left and right selection keys for ‘OK’ and ‘Enter’.
2.4 Setting up
The Alere DDS2 Mobile Analyser does not require any installation steps. The analyser can be connected to
mains power, to the printer and to a PC using the cables provided in the system Carry Case. Use only the
connections and printer provided. Alternative connections and printers should not be used as these may be
unsafe or incompatible with the analyser.
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.
2.5 Mains power
The Alere DDS2 Mobile Analyser can be powered from mains A/C power or by its internal batteries.
To connect the analyser to the mains:
Step 1: Insert the A/C power cable into the power supply unit.
Step 2: Connect the power supply unit to the power supply connector, located at the top of the analyser.
Step 3: Connect to the corresponding A/C power socket.

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Alere™ DDS®2 Mobile Analyser User Guide | 2. Getting Started
Step 4: Turn on the analyser by pressing the power button.
Step 5: If mains power is connected when the analyser is running from batteries, the analyser will switch to the mains
supply as a power source. When the analyser is connected to the mains power, the mains connected symbol
will be displayed in the status line:
Do not use cables or power supply units that are damaged as there may be risk of electric shock.
If the analyser battery requires charging, the battery charging symbol will be displayed when the
analyser is connected to the mains power.
2.6 Battery power
The Alere DDS2 Mobile Analyser will automatically operate from battery when turned on if not connected to
the mains. If mains power is lost or interrupted, the analyser will switch to battery power automatically. To
switch to battery power when in use, simply disconnect the analyser from the mains supply.
When running the analyser on battery power, the battery charge level is displayed by the battery status
symbol within the status line as shown below:
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.
If the battery level reaches critically low level the screen will display a nearly empty battery symbol with the
final bar red. The battery symbol in the status bar will have a red outline. The screen will appear for a few
seconds before the analyser turns off.
See the following section 2.7 Charging the Alere DDS2 Mobile Analyser, for how to charge the analyser when
the batteries are low.
2.7 Charging the Alere DDS2 Mobile Analyser
The Alere DDS2 Mobile Analyser is supplied with a partially charged battery which is secured within the
analyser. To charge the battery, connect the analyser to the mains A/C power as follows:
Step 1: Insert the A/C power cable into the power supply unit.
Step 2: Connect the power supply unit to the power supply connector port located at the top of the analyser.
Step 3: Connect to the corresponding A/C power socket.
Upon connecting the mains A/C the charging status light above the display will illuminate. A red light means
the battery is charging, a green light indicates the battery is fully charged.
Step 5

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Alere™ DDS®2 Mobile Analyser User Guide | 2. Getting Started
The charging status light will only be illuminated when connected to mains A/C power.
In order to ensure maximum battery life, charge the analyser battery for a minimum of 5 hours
before running the analyser on battery power.
It is recommended to charge the printer every time the analyser is charged; if the Alere DDS2 Mobile Test
System is in storage, the analyser and printer should be charged every 2-3 months to ensure the batteries
remain in good condition.
2.8 Tilt sensor
The Alere DDS2 Mobile Analyser should be used in a horizontal plane, and once the Alere DDS2 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. The analyser has an in-built tilt sensor which will display a warning on the screen when
the analyser is tilted beyond the acceptable range. If tilting is not corrected immediately, this may result in a
test error.
2.9 Silica gel packs
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.
The silica gel packs are yellow/orange when dry, indicating that the test kit has been stored correctly and has
not been exposed to the external environment. When moisture has been absorbed, the silica packs will turn
to light green, indicating that water vapour has entered the packaging.
The silica gel pack should be checked each time a test cartridge is opened. If the silica gel pack is
green, discard the test cartridge and contact Product Support, as the performance of the product
may have been compromised. If the silica gel has burst, discard the test cartridge and contact
Product Support.
Slight discolouration of the silica beads is normal. When the majority of the beads within the pack are green,
the test cartridge should not be used.

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Alere™ DDS®2 Mobile Analyser User Guide | 3. Printer
3 Printer
3.1 Connecting the printer
To connect the Alere DDS2 Mobile Analyser to the printer use the RJ12 connector cable provided. Attach
this cable to the base of the printer and to the RJ12 printer connector on the top of the analyser, behind the
rubber flap. Refer to section 2.1 Alere DDS2 Mobile Analyser at a glance for the location of connections.
Switch the printer on by pressing the power button on the top of the printer. The green status light on the
printer will then come on. To turn the printer off, press the power button again so that the status light goes off.
3.2 Loading paper
The printer is supplied with one roll of paper already loaded. To load a new roll of paper into the printer, open
the paper cup lid and remove the spool and any remaining paper. Reel off a few centimetres from the new
roll of paper and hold approximately 5cm of paper outside of the printer. Place the new roll into the paper
reservoir with the paper feeding forwards from the bottom of the roll and the leading edge over the tear bar.
Close the lid by applying equal amounts of pressure on each side of the paper cup lid until the lid is in the
locked position.
Please contact your distributor or Product Support to order replacement printer paper rolls.
3.3 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.
The printer will not charge if it is online, indicated by the printer status light remaining on; or if the analyser is
not connected to the mains.
The printer will take approximately 2-3 hours to charge.
See section 2.5 Mains Power, for more information on how to connect the analyser to the mains.

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Alere™ DDS®2 Mobile Analyser User Guide | 4. Start-up
4 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.
The analyser will perform start-up checks during the start-up process to make sure it is in a good operating
condition. During this testing, the start-up screen will be displayed:
The analyser will not be able to run start-up checks if a Alere DDS2 Test Cartridge is already
inserted. Please remove the test cartridge before switching on.
A new test cannot be initiated if the analyser is already connected to the Alere Software
Application Suite. Disconnect the USB cable before inserting a new test cartridge.
The operational temperature range for running a test is between 5°C to 35°C. Outside of this range
the following message will be displayed:
Allow the analyser to reach ambient temperature before use. If moving the analyser between
storage and operating environments of different temperatures or humidities, this may take
at least 30 minutes. If climatic differences are significant, allow more than 30 minutes for the
analyser to acclimatise.

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Alere™ DDS®2 Mobile Analyser User Guide | 5. Using the Help Function
5 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.
The analyser has an on-board help function which provides additional guidance. To access the help screens,
press the right select key when the help button is displayed on the screen. The help option can only be
accessed if the help button is shown – see the example below. If additional help is required, please contact
Product Support for assistance.

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Alere™ DDS®2 Mobile Analyser User Guide | 6. Running a Drug Test
6.1 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.
Step 2: When the analyser is ready to begin a test, the screen below will appear:
6.2 Inserting the Alere DDS2 Test Cartridge
Step 1: Remove a new Alere DDS2 Test Cartridge from the foil wrapper.
The test cartridges and Alere DDS2 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 Alere DDS2
Mobile Analyser or re-use the collection device.
Step 2: Check the silica gel pack is yellow. If the silica gel is green, discard the test as the performance of the
product may have been compromised. See section 2.9 Silica Gel Packs, for more information.
Step 3: Insert the test cartridge into the test cartridge slot on the front of the analyser.
Step 1 Step 2 Step 3
6 Running a Drug Test

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Alere™ DDS®2 Mobile Analyser User Guide | 6. Running a Drug Test
6.3 Alere DDS2 Test Cartridge identification and verification of the expiry date
Following insertion of the Alere DDS2 Test Cartridge, the Alere DDS2 Mobile Analyser will read the barcode to
identify the test cartridge and verify that it is within its expiry date. The analyser will also check that the test
cartridge type is installed on the analyser. If the test cartridge has expired, it must not be used and the testing
process must be restarted with a new test cartridge that is within its expiry date.
If the test cartridge is not valid, refer to section 13 Technical Support, Codes and Troubleshooting.
6.4 Sample collection
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.
Step 2: The donor must actively swab the collection device around the gums, tongue and inside the cheek,
until the sample presence indicator starts to turn blue.
Step 3: Insert the collection device into the test cartridge (this should already be inserted into the analyser). Gently
push the collection device all the way into the test cartridge to the stop position.
Step 1 Step 2 Step 3

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Alere™ DDS®2 Mobile Analyser User Guide | 6. Running a Drug Test
Once the sample collection device has been inserted, the analyser should be kept in a horizontal
plane remaining as still as possible throughout testing. If the analyser is tilted beyond the
acceptable range, this warning symbol will appear on the screen:
Correct the orientation of the analyser immediately to prevent disruption to the test. See section 2.8 Tilt
Sensor, for more information about the tilt sensor.
6.5 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.
When the analyser has finished processing the test, a results screen will be displayed. Results are displayed
as positive, negative or lab test required against each drug group, depending on which results display option
has been set up on the analyser. To change the results display, refer to section 10.5 Results display.
Select OK using the right select 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.