Abbott SoToxa TOX400PHO User manual

USER GUIDE
EN
SoToxa™
MOBILE ANALYSER

SOTOXA™ MOBILE ANALYSER | USER GUIDE1 | EN
TABLE OF CONTENTS
Contents
1. Introduction 1.1 Intended use 3
1.2 Test principle 3
1.3 SoToxa™ Mobile Analyser specifications 4
1.4 Transport and unpacking 4
1.5 Accessories 5
1.6 Special feature 5
1.7 Data handling 5
1.8 Safety warnings and precautions 5
1.9 Analyser calibration 6
1.10 Maintenance and cleaning 6
1.11 Servicing 6
1.12 Warranty 6
1.13 Drug abbreviations 6
2. Getting started 2.1 SoToxa™ 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 9
2.7 Charging the analyser 10
2.8 Tilt sensor 10
2.9 SD card slot 11
2.10 Silica gel packs 11
3. Printer 3.1 Connecting the printer 11
3.2 Loading paper 11
3.3 Charging the printer 11
4. Start-up 12
5. Using the Help Function 12
6. Running a Drug Test 6.1 Initiating a drug test 13
6.2 Inserting the test cartridge 14
6.3 Test cartridge identification and verification of the expiry date 14
6.4 Sample collection 15
6.5 Test in progress and interpretation of results 16
6.6 Printing results 16
6.7 Completing the test 17
7. Main Menu 17
8. Accessing Stored Results 8.1 View results from memory 17
8.2 Print results from memory 18
8.3 Analyser summary 19
8.4 Results storage capacity 19
9. Analyser Settings 9.1 Setting the date and time 20
9.2 Changing the volume settings 20
9.3 Backlight settings 21
9.4 Automatic shutdown 21
10. Using the SD Card 10.1 Updating firmware 22
10.2 Updating test cartridge types 22
10.3 Exporting diagnostic data 23

SOTOXA™ MOBILE ANALYSER | USER GUIDE2 | EN
TABLE OF CONTENTS
11. Shutdown Procedure 11.1 Turning the analyser o 24
11.2 Automatic shutdown 24
12. Technical Support, Codes and Troubleshooting 12.1 Technical support 24
12.2 Codes and troubleshooting 25
12.3 Symbols Glossary 26
13. End of Operational Life 13.1 Return of components 27
14. Privacy Policy 27
15.
Product Support 27

SOTOXA™ MOBILE ANALYSER | USER GUIDE3 | EN
1. INTRODUCTION
The SoToxa™ Mobile Analyser is intended to be used in conjunction with the SoToxa™ 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 GC-MS (gas chromatography-mass spectrometry) or LC-MS (liquid
chromatography-mass spectrometry).
Please read this User Guide and the Test Kit Instructions for Use carefully, prior to using the analyser.
TOX400PHO | TOX400SHO
1. Introduction
1.1 Intended use
The SoToxa™ Mobile Analyser is intended to be used in conjunction with the SoToxa 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 GC-MS (gas chromatography–mass spectrometry) or LC-MS (liquid
chromatography–mass spectrometry).
1.2 Test principle
1.2.1 The SoToxa™ Mobile Test System consists of the SoToxa Mobile Analyser, and the SoToxa Test Kits which contain the SoToxa™ Test Cartridge and the
SoToxa™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 cartridge that contains dried reagents and a liquid buer 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 buer solution, mixed and then incubated before being applied to the immunoassay test strips
housed within the 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 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.
1.2.11 Test results are displayed on the analyser screen and can be printed using the printer.
1.2.12 The test cartridge is then removed from the analyser and disposed of in accordance with local and national regulations.

SOTOXA™ MOBILE ANALYSER | USER GUIDE4 | EN
1. INTRODUCTION
1.3 SoToxa™ Mobile Analyser specifications
ANALYSER
Dimensions (mm) L 222 × W 88 × H 61
Weight Approximately 680g
Detection system Digital imaging device.
Controls
Cartridge and collector sensors. Cartridge recognition using 2D barcodes for identifying cartridge type, ID, batch and expiry date.
Sensor providing feedback on angle of inclination of analyser. Cartridge heating with temperature control. Internal start-up checks and
process controls during testing. Quality control test cartridges.
Display LCD colour screen 3.2”
User interface Five way navigation key, left and right select keys, power button, reset button.
Electrical rating I5V 3A (via external PSU). The reader is only charged/powered by the supplied PSU and cables.
Languages English.
Memory Data storage capacity of over 10,000 tests, the last test result can be accessed on the analyser by the operator.
SD card SD card connectivity for firmware and cartridge updates and export of diagnostic data.
USB Interface To communicate with the 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 3.2Ah 11.1V lithium battery
PRINTER
Dimensions (mm) L 150 × W 80 × 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
SoToxa Mobile Analyser is operational down to 5˚C at an unquantified relative humidity.
1.4 Transport and unpacking
The SoToxa Mobile Analyser and its accessories are supplied in a convenient carrying case, and all have been fully inspected and tested. Upon receiving the 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 Product Support immediately.
The SoToxa Mobile Analyser 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.

SOTOXA™ MOBILE ANALYSER | USER GUIDE5 | EN
1. INTRODUCTION
1.5 Accessories
The following items are supplied with the SoToxa Mobile Analyser:
• SoToxa Mobile Analyser User Guide CD-ROM.
• Carry case.
• Power supply unit and power cable.
• Micro USB cable for connection to a PC if Software Application Suite is used.
• QC test cartridge set.
• Printer and RJ12 printer cable.
The following item may be required, but is not supplied with the SoToxa Mobile Test System:
• Small Phillips head screwdriver. This tool is required to access the SD card. Refer to section 10 Using the SD Card.
1.6 Special feature
• The SoToxa 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 test cartridge (PQC and NQC). These performance checks are carried out as part of
every drug test.
• The analyser has internal sensors to detect the presence and position of the test cartridge and 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 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 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.
1.7 Data handling
• The SoToxa Mobile Analyser is capable of 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 Software Application Suite, when this has been installed on a PC.
• Test diagnostic data can be exported from the analyser to an SD card, if required and instructed to by Product Support on behalf of the manufacturer.
Please refer to section 10.3 Exporting diagnostic data for further information.
• Firmware upgrades and new test cartridge configurations can be uploaded to the analyser from an SD card, when these are released by the manufacturer.
If test data is downloaded to the Software Application Suite it is automatically deleted from the analyser.
1.8 Safety warnings and precautions
• WARNING: The analyser and 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 SoToxa Mobile Test System and any implanted device. If you feel unwell whilst using
the analyser, 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 AC 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 Software Application Suite (if used) carry up to date antivirus software.
• The SoToxa 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 dierent temperatures
or humidity’s, this may take at least 30 minutes. If climatic dierences 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.

SOTOXA™ MOBILE ANALYSER | USER GUIDE6 | EN
1. INTRODUCTION
1.9 Analyser calibration
The SoToxa Mobile Analyser is factory calibrated and does not require any further calibration by the user.
However, it is recommended to carry out performance checks using the quality control test cartridges provided with the system as part of each test.
1.10 Maintenance and cleaning
If required, the exterior of the 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 o and disconnected from mains AC power.
DO NOT try to clean inside the analyser or open the analyser for cleaning.
The SoToxa Mobile Analyser does not contain any user serviceable components. If a fault is suspected or routine factory maintenance is required, then please
contact Product Support.
Only use the printer and USB cables supplied with the analyser, do not attempt to connect any other equipment to the analyser as this may damage the
equipment or be hazardous to the user.
1.11 Servicing
The SoToxa 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 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.
1.12 Warranty
The SoToxa 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 systems for loss, theft or damage caused by the user.
1.13 Drug abbreviations
DRUG ABBREVIATIONS
Abbreviation Drug Name
COC Cocaine
OPI Opiates

SOTOXA™ MOBILE ANALYSER | USER GUIDE7 | EN
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
TEST CARTRIDGE SLOT
POWER BUTTON
2. Getting started
2.1 SoToxa™ Mobile Analyser at a glance

SOTOXA™ MOBILE ANALYSER | USER GUIDE8 | EN
2. GETTING STARTED
2.2 User interface and symbols
The SoToxa 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 9 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:
SOTOXA 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 10.3 Exporting diagnostic data 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 8.4 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 10.3 Exporting
diagnostic data. 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 result 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.
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 Customer Service to arrange a service for the SoToxa Mobile Test System.
Service symbol (orange): When service is overdue, the service symbol will turn orange. Contact Customer Service to arrange a service for the
SoToxa Mobile Test System. Accuracy of test results may be reduced if a service is overdue.

SOTOXA™ MOBILE ANALYSER | USER GUIDE9 | EN
2. GETTING STARTED
2.3 Control keys
The SoToxa 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SoToxa 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 idle screen and
the prompt to insert the PQC cartridge, 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 menu options. 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 SoToxa 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 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.
2.5 Mains power
The SoToxa Mobile Analyser can be powered from mains AC power or by its internal batteries. To connect the analyser to the mains:
Step 1: Insert the AC 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 AC power socket.
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 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:
Step 5

SOTOXA™ MOBILE ANALYSER | USER GUIDE10 | EN
2. GETTING STARTED
The number of tests that the analyser can perform from one full battery charge will vary depending on the type of 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.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 o.
See the following section 2.7 Charging the analyser, for how to charge the analyser when the batteries are low.
2.7 Charging the analyser
The SoToxa 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 AC power as follows:
Step 1: Insert the AC 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 AC power socket.
Upon connecting the mains AC 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.
The charging status light will only be illuminated when connected to mains AC 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 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 SoToxa Mobile Analyser should be used in a horizontal plane, and once the sample 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.

SOTOXA™ MOBILE ANALYSER | USER GUIDE11 | EN
2. GETTING STARTED | 3. PRINTER
2.9 SD card slot
The analyser has a microSD card slot. Refer to section 2.1 SoToxa 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 system.
Please contact Product Support if access to the SD card is required.
The SD card can also be used for applying firmware updates to the analyser, adding new test cartridge types or versions to the analyser and exporting
of diagnostic data from the analyser to the card. Information on how to use the SD card for updating information on the analyser is covered in section
10.1Updating firmware.
2.10 Silica gel packs
Each foil wrapped 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 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 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.
3. Printer
3.1 Connecting the printer
To connect the SoToxa 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 SoToxa 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 o,
press the power button again so that the status light goes o.
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 o 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 Product Support to order replacement printer paper rolls.
3.3 Charging the printer
The printer will only charge when it is oine and connected to the 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.

SOTOXA™ MOBILE ANALYSER | USER GUIDE12 | EN
4. START-UP | 5. USING THE HELP FUNCTION
4. Start-up
‘Important – Please read the instructions for use in full provided with the SoToxa Test Kit, prior to commencing a test’.
Turn on the SoToxa 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 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 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 SoToxa Mobile Analyser to reach ambient temperature before use. If moving the analyser between storage and operating environments of
dierent temperatures or humidity’s, this may take at least 30 minutes. If climatic dierences are significant, allow more than 30 minutes for the analyser
to acclimatise.
5. Using the Help Function
The SoToxa 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.

SOTOXA™ MOBILE ANALYSER | USER GUIDE13 | EN
6. RUNNING A DRUG TEST
6. Running a Drug Test
Prior to collecting and testing a sample taken from a donor, the analyser will prompt you to complete QC testing. QC stands for Quality Control. Two
reusable QC test cartridges are supplied with the SoToxa Mobile Analyser:
• Positive Quality Control (PQC).
• Negative Quality Control (NQC).
These two 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.
6.1 Initiating a drug test
Step 1: Refer to section 4 Start-up to switch on the analyser. Check that both QC cartridges are clean and undamaged. If the QC cartridges are marked, please
contact Product Support.
Step 2: When the analyser is ready to begin a test, the screen below will appear:
Step 3: Insert the QC cartridge, the cartridge will be analysed automatically. The order in which the QC cartridges are inserted is not important, as the analyser is able
to recognise the cartridge that has been inserted and will analyse it accordingly.
Step 4: Once analysis of the PQC cartridge is finished, the system will prompt you to remove the current cartridge and insert the NQC cartridge.
Step 5: Following analysis of the second NQC cartridge, you will be prompted to start the drug test process. Remove the NQC cartridge.
Step 2
Step 3 Step 3
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6. RUNNING A DRUG TEST
Please note: If the QC tests have failed, (see image below) contact Product Support. You will not be able to continue testing until the QC process has been
completed successfully.
6.2 Inserting the test cartridge
Step 1: Remove a new test cartridge from the foil wrapper.
The SoToxa Test Cartridges and SoToxa 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 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
2.10Silica gel packs, for more information.
Step 3: Insert the test cartridge into the cartridge slot on the front of the analyser.
6.3 Test cartridge identification and verification of the expiry date
Following insertion of the test cartridge, the analyser will read the barcode to identify the 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 12 Technical Support, Codes and Troubleshooting.
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6. RUNNING A DRUG TEST
6.4 Sample collection
Following 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 analyser screen or refer to the instructions for use insert supplied with the test kit.
Step 1: Ask the donor to remove the SoToxa 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.
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.
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6. RUNNING A DRUG TEST
6.5 Test in progress and interpretation of results
When the collection device has been inserted into test cartridge in the 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, or negative, against each drug group.
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.
6.6 Printing results
If the results have been accepted, the analyser will give the option to print results.
Step 1: If not already connected, attach the printer to the SoToxa Mobile Analyser (refer to section 3.1 Connecting the printer) and ensure the printer is switched on.
Step 2: To print results, select OK using the right 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 completed, for the first of the required four printouts, the print option screen will be displayed again to give you the choice to print additional
copies of results.
Repeat steps two and four for the remaining copies. A total of four copies should be printed: three standard, one summary.
Step 2 Step 2 Step 3

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6. RUNNING A DRUG TEST | 7. MAIN MENU | 8. ACCESSING STORED RESULTS
6.7 Completing the test
At the end of testing when results have been displayed and printed, the analyser will prompt the user to remove the test cartridge. Do not remove the test
cartridge by pulling the 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 cartridge may be hot. Handle the test cartridge by the side edges.
7. Main Menu
The SoToxa 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 test cartridges that are installed on the analyser. See the
following sections for more details.
8. Accessing Stored Results
The SoToxa Mobile Analyser will store test information and results which can then be viewed and printed.
8.1 View results from memory
Step 1: From the main menu, select the View Last Test option.
Step 1

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8. ACCESSING STORED RESULTS
Step 2: The last test 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 3: Exit this screen to return to the test options screen.
Step 4: From the test options screen, highlight and select View Results to see test results.
Step 5: The results for the selected test are then displayed (this is an example test).
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.
8.2 Print results from memory
Step 1: From the test options screen, highlight and select either Print Summary or Print Standard. Before selecting print, ensure that the printer is connected and online.
See section 3.1 Connecting the printer.
Step 2: Printing will then start.
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Step 4 Step 5
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8. ACCESSING STORED RESULTS
8.3 Analyser summary
An overview of the key settings and dates that are important to the use of the analyser can be viewed in the Analyser Summary screen.
Step 1: From the main menu screen select the Analyser Summary option.
Step 2: The Analyser Summary screen will then be displayed.
Step 1 Step 2
The information detailed on the screen is:
SCREEN DISPLAY
S/N Serial number of the analyser. Also stated on the label on the underside of the analyser.
Test Count The number of tests completed expressed with the total test storage capacity. See section 8.4 Results storage capacity for further information.
Battery Level Current battery level in mV.
Firmware Version that is loaded on the analyser. See section 10.1 Updating firmware for further information
Bootloader Version that is loaded on the analyser.
8.4 Results storage capacity
The SoToxa 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.