Alere DDS 2 User manual

EN
Alere™DDS®2 Mobile Analyser
User Guide

[phone] | aleretoxicology.co.uk
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.

APOC0274 Ed.3a
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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

APOC0274 Ed.3a
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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