Alere DDS 2 Mobile Analyser

®
™

User Guide

EN
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 Introduction
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.

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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

English, Spanish, Italian, German, Croatian, Turkish, Portuguese, Russian, Slovakian,

Languages 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:

Step 1 Step 2

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.

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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

2.1 Alere DDS2 Mobile Analyser at a glance

Charging status light

Power button

LCD screen

Left select key Right select key

Five way navigation key

Alere DDS2 Test Cartridge slot

Right selection key

Power supply connector Five way navigation key

Reset button
Left selection key

Speaker

SD card cover panel

RJ12 printer connector

USB connector Rubber flap

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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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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:

Step 5

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.

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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 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

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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.

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Alere™ DDS®2 Mobile Analyser User Guide | 6. Running a Drug Test

6.6 Completing the questionnaire

The Alere DDS2 Mobile Analyser allows additional donor information to be captured alongside the test result.
If the questionnaire set has been enabled on the analyser, the questionnaire will be entered following the
results screen. The questionnaire can be enabled or disabled by changing the analyser settings. Refer to
section 10.6 Questionnaire for instructions on how to enable and disable the questionnaire.
The questions included in the questionnaire can be configured using the Alere Software Application Suite.
If the Software Application Suite is not being used, the analyser will use the standard questionnaire set.
Step 1: Use the five way navigation key to scroll either up or down, or left to right to select the
correct information.
Step 2: Any of the individual questions can be skipped by either selecting Skip, or scrolling through the options until
Skip or – is reached.
Step 3: To make a selection, press OK.
Step 4: At the end of the questionnaire, a summary of the information entered will be displayed.

Step 3 Step 4

Step 5: If the information is correct, select OK using the right select key or if something needs to be changed, select
Back with the left select key to return to the questions.
Step 6: Selecting OK will accept the questionnaire and move on to the next screen.

6.7 Printing results

If the results and questionnaire (if used) have been accepted, the Alere DDS2 Mobile Analyser will give the
option to print results.
Step 1: If not already connected, attach the printer to the analyser (refer to section 3.1 Connecting the printer) and
ensure the printer is switched on.
Step 2: To print results, select Yes using the left select key.
Step 3: Failure to connect or switch on the printer will lead to the print failure screen. Check connections, switch on
the printer and select Retry to return to the previous screen. Alternatively select Cancel to skip printing.
Step 4: After printing is complete, the print option screen will be displayed again to give you the choice to print
additional copies of results.
Step 5: If printing is not required, select No on the print options screen.

Step 2 Step 2 Step 3

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Alere™ DDS®2 Mobile Analyser User Guide | 6. Running a Drug Test

6.8 Completing the test

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

Dispose of the used test cartridge and collection device according to local and national regulations.

Take care when removing the test cartridge as the underside of the test cartridge may be hot.
Handle the test cartridge by the side edges.

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Alere™ DDS®2 Mobile Analyser User Guide | 7. QC Tests

7 QC Tests

7.1 What are the QC tests?

QC stands for Quality Control. Two reusable QC Alere DDS2 Test Cartridges are supplied with the Alere DDS2
Mobile Analyser:
„„ Positive Quality Control (PQC)
„„ Negative Quality Control (NQC)
These two test cartridges are tested in sequence to check that the analyser is interpreting test cartridge
results correctly. If the QC tests pass, this means that the analyser is working correctly.

7.2 How often should the QC tests be carried out?

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

7.3 Running the QC tests

Step 1: Check that both QC Alere DDS2 Test Cartridges are clean and undamaged. If the QC test cartridges are
marked, please contact Product Support.
Step 2: Insert one of the two QC test cartridges, the test cartridge will be analysed automatically. The order in which
the QC test cartridges are inserted is not important, as the Alere DDS2 Mobile Analyser is able to recognise
the test cartridge that has been inserted and will analyse it accordingly.

Step 2 Step 2

Step 3: Once analysis of the first QC test cartridge is finished, the Alere DDS2 Mobile Test System will prompt you to
remove the current test cartridge and insert the other QC test cartridge. Note that if QC failed on the first test
cartridge, QC testing will be abandoned.

Step 3

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Alere™ DDS®2 Mobile Analyser User Guide | 7. QC Tests | 8. Main Menu

Step 4: Following analysis of the second QC test cartridge, results of the QC test will be displayed as ‘QC Results:
Pass’ or ‘QC Results: Fail’.
Step 5: If the QC tests have failed, contact Product Support. Do not continue testing.
Step 6: After acknowledging the results by selecting OK, the analyser will prompt you to remove the test cartridge,
to complete the QC testing.

Step 4 Step 4 Step 6

Step 7: If you wish to print the QC results, please select the View Results option from the main menu to print the
individual QC tests. See section 9 Accessing Stored Results.

8 Main Menu

The Alere DDS2 Mobile Analyser main menu screen (shown on the right below) can be reached from the
default screen (shown on the left below) by pressing the left selection key.
From this screen you can access stored results, view the analyser summary and settings and check the Alere
DDS2 Test Cartridges that are installed on the analyser. See the following sections for more details.

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Alere™ DDS®2 Mobile Analyser User Guide | 9. Accessing Stored Results

9 Accessing Stored Results

The Alere DDS2 Mobile Analyser will store test information and results which can then be viewed and printed.

9.1 View results from memory

Step 1: From the main menu, select the View Results option.

Step 1

Step 2: The stored results screen will display the last 100 tests performed if they haven’t been downloaded to the
Alere Software Application Suite. Select the test you wish to view using the five way navigation key to scroll
up and down through the tests, then press the Options button using the left selection key. The most recent
tests are at the top of the screen. Tests are identified by a unique test ID number. This number is also printed
on the results printout.
Step 3: The test options screen will then be displayed. From this screen, you can view the test details by selecting
View Details and pressing OK. The screen will then display the following information about the selected test
(this is an example test):

Step 2 Step 3 Step 3

Step 4: Exit this screen to return to the test options screen.

Step 5: From the test options screen, highlight and select View Results to see test results (this is an example test).
Step 6: The results for the selected test are then displayed (this is an example test).

Step 5 Step 6

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Alere™ DDS®2 Mobile Analyser User Guide | 9. Accessing Stored Results

If an error has occurred during the test, the results will not be available to view, so this option will
not be displayed on the test options screen.

9.2 Print results from memory

Step 1: From the test options screen, highlight and select Print. Before selecting print, ensure that the printer is
connected and online. See section 3.1 Connecting the printer.
Step 2: Printing will then start.

Step 1 Step 2

9.3 Downloading results to the Alere Software Application Suite

If the Alere Software Application Suite is being used, test data stored on the Alere DDS2 Mobile Analyser can
be downloaded by connecting the analyser to a PC on to which the Software Application Suite has been
installed. The Software Application Suite can be used to store and view test data and allows generation
of reports from the stored data. The Software Application Suite is not compatible with Apple Macintosh/
Mac operating systems. For details of the PC operating systems which are compatible with the Software
Application Suite, please refer to the Software Application Suite user guide which can be found on the
Software Application Suite CD-ROM.

The analyser must not be connected to the Software Application Suite whilst a test is in progress.

Step 1: Ensure the Software Application Suite is installed on the PC. For installation instructions, refer to the Software
Application Suite user guide on the Software Application Suite CD-ROM.
Step 2: When the analyser is on the main menu screen, physically connect the analyser to the PC via the micro USB
cable provided. The USB connector is beneath the rubber flap at the top of the analyser. See section 2.1
Alere DDS2 Mobile Analyser at a glance.
Step 3: Launch the Software Application Suite on the PC by double clicking the Software Application Suite icon.
Step 4: The analyser will appear in the analyser main menu of the Software Application Suite. Click on this to connect
to the analyser.
Step 5: Once connected to the Software Application Suite, the analyser will display the following screen:

Step 5

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Alere™ DDS®2 Mobile Analyser User Guide | 9. Accessing Stored Results

Step 6: Follow the Software Application Suite instructions. Do not disconnect the analyser during data transfer.
Step 7: It is recommended that results stored on the analyser are regularly downloaded to the Software Application
Suite to ensure that data is backed up. Frequency of downloads will be dependent on testing volumes. To
find out more about how to use the Software Application Suite, refer to the Software Application Suite user
guide which can be found on the Software Application Suite CD-ROM.

9.4 Results storage capacity

The Alere DDS2 Mobile Analyser can store over 10,000 test results. When storage capacity is nearly
reached, the white memory symbol will be displayed in the status line.

When storage capacity is reached, the orange memory symbol will be displayed. Before saving the next test
result, the memory full screen will be displayed. Select Continue to overwrite the oldest test with the new
result, or select Cancel. Selecting cancel will mean the new test result is not saved.
To find out how much storage space is left, carry out the following steps:
Step 1: From the main menu, select the Analyser Summary option.
Step 2: The following screen will display the number of tests performed under Test count:

Step 1 Step 2

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

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Alere™ DDS®2 Mobile Analyser User Guide | 10. Alere DDS2 Mobile Analyser Settings

10 Alere DDS2 Mobile Analyser Settings

10.1 Alere DDS2 Mobile Analyser language settings

To alter the language settings on the Alere DDS2 Mobile Analyser, select the Analyser Settings option from
the main menu, and then select the Language option.

Use the five way navigation key to highlight the language required, and apply this to the analyser by
selecting OK.

10.2 Setting the date and time

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

10.3 Changing the volume settings

To alter the volume setting on the Alere DDS2 Mobile Analyser, select the Analyser Settings option from the
main menu, then in the analyser settings screen, select the Sound Control option.
Use the five way navigation key to select the required volume setting, then press OK to save the settings.

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Alere™ DDS®2 Mobile Analyser User Guide | 10. Alere DDS2 Mobile Analyser Settings

10.4 Backlight settings

To alter the backlight setting on the Alere DDS2 Mobile Analyser, select the Analyser Settings option from
the main menu, then in the analyser settings screen, select the Backlight option.

In the backlight screen, the first menu item allows you to change the backlight level; the second one enables/
disables the backlight auto-shut down, where the backlight is turned off after 15 seconds of inactivity, to save
battery power. Press OK to save the settings.

10.5 Results display

The Alere DDS2 Mobile Analyser is a screening device and all positive screens should be confirmed by a
second test method such as Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-
Mass Spectrometry (LC-MS). Both of these confirmatory methods are laboratory tests.
Test results can be displayed on the analyser in the following formats:

Results Display

Laboratory Confirmation
Results Display Meaning
Recommended

The drug or metabolites of the drug have been

Positive Yes
detected in the sample at levels above the cut off.

The drug or metabolites of the drug have not been

Negative No
detected in the sample at levels above the cut off.

The drug or metabolites of the drug have been

Lab Test Required Yes
detected in the sample at levels above the cut off.

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

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Alere™ DDS®2 Mobile Analyser User Guide | 10. Alere DDS2 Mobile Analyser Settings

The analyser can either display results as positive/negative or as lab test required/negative. To change the
results display, select the Analyser Settings option from the main menu, then in the Analyser Settings
screen, select the Results Display option. In the Results Display screen, use the five way navigation key to
highlight the results display required, then press OK to save the settings.

10.6 Questionnaire
To enable or disable the questionnaire, select the Analyser Settings option from the main menu, then in the
Analyser Settings screen, select Questionnaire.
In the Questionnaire screen, the first option enables the questionnaire set and the second option disables it.
Use the five way navigation key to select the required settings. Press OK to save the settings.

10.7 Automatic shut down

The Alere DDS2 Mobile Analyser can be set to automatically shut down after a period of inactivity to save
power. The automatic shut down function can be set to on or off and the time period before shut down can
be selected.
Select Analyser Settings from the main menu, then in the Analyser Settings screen, select Auto Shut
Down. In the Auto Shut Down screen, use the five way navigation key to highlight the required setting and
press OK to save the setting.

The analyser will not automatically shut down while a test is in progress or if a Alere DDS2 Test
Cartridge is inserted.

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Alere™ DDS®2 Mobile Analyser User Guide | 11. Using the SD Card

11 Using the SD Card

The Alere DDS2 Mobile Analyser has a microSD card slot. Refer to section 2.1 Alere DDS2 Mobile Analyser at
a glance for the location of the SD card cover panel. The SD card socket can only be accessed by unscrewing
the SD card cover panel. For this a small Phillips head screw driver is needed. This tool is not supplied with the
Alere DDS2 Mobile Test System. Please contact Product Support if access to the SD card is required.
The SD card can be used for applying firmware updates to the analyser, adding new Alere DDS2 Test
Cartridge types or versions to the analyser and exporting of diagnostic data from the analyser to the card.

11.1 Updating firmware

When firmware updates are available these may be provided by the manufacturer by way of a replacement
SD card.

D
 ata may be lost during the updating process. Where possible please ensure that data is backed
up prior to completing the update.

To update Alere DDS2 Mobile Analyser firmware using the SD card, follow these steps:
Step 1: Ensure that the new SD card is inserted in the analyser before starting this procedure.
Step 2: From the main menu, select the Analyser Summary option.
Step 3: When in the Summary Screen, press the Update button on the bottom left of the screen.
Step 4: The analyser will display the list of files and folders carried on the inserted SD card. To open a folder, highlight
the folder using the five way navigation key, then press the Enter button. To exit a folder, select the top folder
marked with an arrow, then press the Enter button.

Step 1 Step 3 Step 4

Step 5: Select the desired firmware file and press the Enter button.
Step 6: If the firmware file is valid, the analyser will automatically update the firmware and reboot itself.

Step 6 Step 6

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Alere™ DDS®2 Mobile Analyser User Guide | 11. Using the SD Card

11.2 Updating Alere DDS2 Test Cartridge types

To use a drug Alere DDS2 Test Cartridge on the Alere DDS2 Mobile Analyser, the test cartridge type must
be installed in order that the analyser recognises the test cartridge. New test cartridge types can be added
to the analyser via the Alere Software Application Suite software or via the SD card. If using the Software
Application Suite, please refer to the Software Application Suite user guide (which can be found on the
Software Application Suite CD-ROM), for instructions on how to update test cartridge types.
To add a new test cartridge type using the SD card, follow these steps:
Step 1: Insert the SD card into the analyser before starting this procedure.
Step 2: From the main menu, select the Installed Cartridges option.
Step 3: In the installed cartridges screen, press Add, on the bottom left of the screen.

Step 2 Step 3

Step 4: The analyser will display the list of files and folders carried on the inserted SD card. To open a folder, select
the folder, then press the OK button. To exit a folder, select the top folder marked with an arrow, then press
the OK button.
Step 5: Select the desired test cartridge file and press the Enter button.

Step 5

Step 6: If the test cartridge file is valid, the analyser will update its test cartridge library and navigate back to the
installed test cartridge screen. The new test cartridge will now appear on the list of installed test cartridges.

Step 6 Step 6

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Alere™ DDS®2 Mobile Analyser User Guide | 11. Using the SD Card

11.3 Exporting diagnostic data

Diagnostic data can be exported from the Alere DDS2 Mobile Analyser to an SD card, if required and
instructed to by Product Support on behalf of the manufacturer. This data can be used to aide with
troubleshooting of a particular issue or as part of routine monitoring of how the Alere DDS2 Mobile Test
System is working.
To export the diagnostic data to an SD card, follow these steps:
Step 1: Insert the SD card into the analyser before starting this procedure.
Step 2: From the main menu, select the Export Diagnostics option.
Step 3: A progress wheel will be displayed while the data is being exported. It may take several minutes to complete
as it is dependent on the number of tests completed on the analyser.

Step 2 Step 3

Step 4: On completion of the export the main menu will be displayed.

Step 5: Turn the analyser off and remove the SD card from the slot and return to Product Support as instructed.
Step 6: Re-screw the card cover into place.
Please note that if the battery is too low, then the warning message shown below will appear when you start to
export the data. Either charge the analyser or simply connect to the mains before starting the export again.

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Alere™ DDS®2 Mobile Analyser User Guide | 12. Shut Down Procedure

12 Shut Down Procedure

12.1 Turning the Alere DDS2 Mobile Analyser off

Step 1: Remove any Alere DDS2 Test Cartridges from the Alere DDS2 Mobile Analyser.
Step 2: Press the power button on the right hand side of the analyser.
Step 3: The screen will read ‘Analyser Shutting Down’.
Step 4: When the screen turns dark, the analyser has switched off.

Step 3

The analyser cannot be switched off if a test is in progress of if a test cartridge is inserted.

12.2 Automatic shut down

In order to save power, the Alere DDS2 Mobile Analyser can be set to automatically shut down after a period
of inactivity. Refer to section 10.7 Automatic shut down.

The analyser will not turn shut down if a test is in progress or if a Alere DDS2 Test Cartridge
is inserted.

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Alere™ DDS®2 Mobile Analyser User Guide | 13. Technical Support, Codes and Troubleshooting

13 Technical Support, Codes and Troubleshooting

13.1 Technical support

In the event of an incomplete test or Alere DDS2 Mobile Analyser issue, in most cases on screen feedback
will be provided to the user to assist with diagnosis and resolution of the issue. In some cases, the analyser
will report specific codes – please refer to the list of codes on the following pages for interpretation. If the
issue cannot be resolved using this guide, please contact Product Support.
Examples of screens:

13.2 Codes and troubleshooting

Please note, the codes listed below are examples. When displayed by the Alere DDS2 Mobile Analyser, the
characters denoted by ‘X’ will be numbers. The first and second numbers are used to denote the type of code.

Codes and Troubleshooting

Code Description Possible Causes Solutions

The test cartridge was not detected

1.1.X.X Cartridge Initiate a QC test, if the QC test fails contact
correctly. Can be due to dirty optics,
to analysis Product Support. If the QC tests pass
a damaged test cartridge or a
1.5.X.X incomplete. complete the test.
hardware fault.

The reference band has not been

Insufficient Ensure that the test process has been
1.6.X.X detected; the sample has not run on
sample. correctly followed.
the test cartridge.

The sample has not run sufficiently

Insufficient on the test cartridge. Can be due Ensure that the test process has been
1.7.X.X
sample. to insufficient sample collection, correctly followed.
incorrect test process.

The test cartridge was not detected

1.8.X.X Cartridge Initiate a QC test, if the QC test fails contact
correctly. Can be due to dirty optics,
to analysis Product Support. If the QC tests pass
a damaged test cartridge or a
1.10.X.X incomplete. complete the test.
hardware fault.

Initiate a QC test. If the QC test passes, verify

During the barcode analysis the that the inserted test cartridge is not used
2.1.X.X analyser has detected a fault this and its barcode is not damaged. If the test
Cannot read
to could be due to the test cartridge/ cartridge or its barcode is damaged, dispose
barcode.
2.6.X.X barcode being damaged, dirty optics of the test cartridge and start a new test
or a hardware fault. with a new test cartridge. If the QC test fails,
contact Product Support.

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Alere™ DDS®2 Mobile Analyser User Guide | 13. Technical Support, Codes and Troubleshooting

Codes and Troubleshooting

Code Description Possible Causes Solutions

The barcode data cannot be

interpreted into valid test cartridge
Barcode Please contact Product Support
2.7.X.X information. The barcode may have
not valid. for assistance.
been tampered with or a newer
barcode version has been introduced.

3.1.X.X Issue
Unable to complete test process. Please
and detected with Analyser hardware issue.
contact Product Support for assistance.
3.2.X.X hardware.

Analyser The analyser appears not to be Tests cannot be completed until the
3.3.X.X calibration calibrated or has lost its calibration analyser is calibrated. Contact Product
required. settings. Support for assistance.

3.4.X.X Issue detected during the test

Test result Restart analyser and start test process again
and analysis, analyser unable to interpret
inconclusive. if applicable.
3.5.X.X the result.

Start-up The analyser has detected a fault

Unable to complete test process.
3.6.X.X checks have during the initial checks and will not
Contact Product Support for assistance.
failed. be able to complete a test.

The analyser has either been reset

Analyser has
by the operator, the battery has run Press Exit to continue. Contact Product
3.7.X.X shut down
out or the analyser was unable to Support for assistance if the problem persists.
unexpectedly.
complete the test analysis.

Do not
remove Initiate a new test, making sure that the test
Test cartridge was removed during
4.1.X.X cartridge cartridge is not removed until the test result
the test process.
during the is displayed.
test.

SD card not SD card is not present within

4.2.X.X Insert a valid SD card into the analyser.
detected. the analyser.

The file selected is not a valid test cartridge

The selected Incorrect file has been selected
file. Make sure a valid test cartridge file
4.3.X.X file is not while trying to install a new test
is selected to be updated. See section 11.2
valid. cartridge file.
Updating Alere DDS2 Mobile Analyser types.

The file selected is not a valid software

The selected Incorrect file has been selected
(firmware) file. Make sure a valid firmware file
4.4.X.X file is not while trying to install a new software
is selected to be updated. See section 11.1
valid. (firmware) version.
Updating Firmware.

During QC testing, the second test cartridge

Incorrect inserted was incorrect. Make sure the PQC
Incorrect QC test cartridge has
4.5.X.X QC cartridge and NQC test cartridges have been used, not
been inserted.
inserted. drug test cartridges. Ensure the same test
cartridge has not been inserted twice.

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Alere™ DDS®2 Mobile Analyser User Guide | 13. Technical Support, Codes and Troubleshooting

Codes and Troubleshooting

Code Description Possible Causes Solutions

Ensure the correct testing process has been

4.6.X.X Cartridge
The analyser detected the inserted followed. Dispose of used test cartridge, start
to appears to
test cartridge as being used. a new test making sure that the inserted test
4.9.X.X be used.
cartridge is new and not used.

Temperature The analyser detected that

Ensure that the test cartridge and analyser are
is outside the the ambient and test cartridge
4.7.X.X within the 5°C to 35°C, and start test again
acceptable temperature are out of the accepted
with a new test cartridge.
range. operating range for testing.

Could not
An issue occurred whilst storing the
4.8.X.X install Try to install the test cartridge file again.
test cartridge definition file.
cartridge file.

Ensure the correct testing process has been

Cartridge
Test cartridge was inserted whilst followed. Remove the test cartridge, return to
4.11.X.X inserted
analyser was in a menu screen. the Waiting for Cartridge Insertion screen and
unexpectedly.
re-insert the test cartridge.

Cartridge not An old test cartridge version has Unable to complete the test process.
4.12.X.X
compatible. been used. Contact Product Support for assistance.

Battery
Low battery could interrupt the
too low to Recharge the analyser or connect to the
4.13.X.X export of data and corrupt the file
complete mains prior to starting the export of data.
system on the SD card.
operation.

Low space on Insufficient space on the SD card to Free space on the SD card being used
4.14.X.X
SD card. allow the export of data. before proceeding.

Cannot write
SD card has been removed or the
4.15.X.X file to SD Restart analyser and reinsert the SD card.
card could be faulty.
card.

Cartridge
Analyser was tilted beyond the Retry using a new test cartridge, keeping the
4.16.X.X analysis
acceptable range. analyser level.
disrupted

The barcode of the inserted

5.1.X.X Cartridge type
test cartridge indicates a test Contact Product Support for the appropriate
and has not been
cartridge type or version that is not test cartridge definition file.
5.2.X.X recognised.
recognised by the analyser.

Dispose of the used test cartridge. Start a

This cartridge The inserted test cartridge new test with a new test cartridge, checking
5.3.X.X
has expired. has expired. the date on the wrapper to make sure that it
has not expired.

6.1.X.X Start-up Ensure the test cartridge is fully removed and

The analyser has detected a fault
to checks have press Restart to try again. If issue persists
during the start-up checks.
6.4.X.X failed. contact Product Support.

The analyser has detected a fault

Start-up Ensure the test cartridge is removed and
during the start-up checks but the
6.5.X.X checks have press Restart to try again. If issue persists
operator has continued and initiated a
failed. contact Product Support.
test by inserting a test cartridge.

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Alere™ DDS®2 Mobile Analyser User Guide | 14. End of Operational Life | 15. Product Support

14 End of Operational Life

14.1 Return of components

At the end of operational life, the Alere DDS2 Mobile Analyser and its electrical or electronic peripherals
including the power supply units (PSUs), and printer, should be returned to the manufacturer. Please contact
Alere Toxicology to make arrangements for return.

No electrical or electronic equipment may be disposed of in conventional domestic or commercial

waste systems.

15 Product Support
For additional technical support and advice please contact Product Support on the details below:
Alere Toxicology, 92 Park Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RY, UK
+44 (0)1235 443 291 | [email protected] | aleretoxicology.co.uk

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© 2017 Alere. All rights reserved.
This document and the Alere DDS2 Mobile Analyser described in it are copyrighted with all rights reserved. Under copyright law; the documentation,
hardware design and the software must not be copied, photocopied, reproduced, translated or reduced to any electronic medium or machine readable
form, in whole or in part, without prior written consent of Alere Toxicology. Failure to comply with this condition may result in prosecution and will void
analyser warranty.
Disclaimer: At Alere Toxicology, we believe in the constant development and improvement of our products and services. We reserve the right to alter,
modify and upgrade our software programs, instrumentation and publications without notice and without incurring liability.
The Alere Logo, Alere and DDS are trademarks of the Alere group of companies.

Alere Toxicology, 92 Park Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RY, UK | Tel: +44 (0)1235 861 483 | APOC0274 Ed.3a