Experiment X Igloo User manual

Experiment X Germany GmbH
Perleberger Straße 42d
D-10559 Berlin
Germany
1
Igloo™ + Dx Care Instructions for Use
Contents
•Introduction
•Intended Use
•Symbols Used in this Manual
oSafety Instructions
oCautions
oGeneral Precautions
oPrerequisites
•Installing, Upgrading and Configuring the Software
•Step-by-Step Instructions
oBefore You Begin
oMeasurement
oDevice Indicator Legend
oCleaning, Turning off and Storing Your Igloo
oTroubleshooting
•Technical Specifications
oTechnical Data
oScope of Delivery
•Customer Support and Service Information
•Copyright Information
Introduction
Thank you for purchasing Igloo, an Experiment X products.
Igloo is a portable electronic measuring device for professional use in combination with in-vitro
lateral flow tests. It supports qualitative, quantitative and semi-quantitative lateral flow
immunochromatographic and colorimetric tests and allows the in-vitro examination of
specimens derived from the human body, as well as other biological samples.
Igloo uses embedded firmware and can be used with its specially designed software only. Igloo
measurement results can only be viewed with such software applications.
Igloo is powered by a 2000 mAh Li-Ion battery or an USB-C cable included in the delivery. The
USB-C cable can also be used for charging the device.
Igloo is a camera-based device enclosed in a plastic case with an LED indicator ring, a touch
sensor/button on the top, and a reset button on the bottom.

Experiment X Germany GmbH
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The slot on the device’s case supports various types of adapters for test cassettes from different
manufacturers. Igloo transmits data via the included USB-C cable, Bluetooth, Wi-Fi and NFC.
While in use, the device might come into contact with potentially infectious materials such as
biological fluids. It is thus recommended to regularly clean the device with a disinfectant solution
such as Mikrozid® AF Liquid, Aerodesin®2000 or similar.
Please read the below instructions carefully before using your Igloo.
Intended Use
Igloo is a portable electronic IVD medical device for professional use intended for reading,
processing and analyzing qualitative, quantitative and semi-quantitative in-vitro lateral flow
immunochromatographic and colorimetric tests.
It is intended to be used as a part of the Experiment X platform comprising Igloo and either the
Dx Studio or the Dx Care application.
It is intended to be used by developers, manufacturers, test distributors or potentially
in pharmaceutical industry.
Igloo should be used in combination with qualitative, quantitative and semi-quantitative lateral
flow immunochromatographic and colorimetric tests for the in-vitro examination of specimens
derived from the human body.

Experiment X Germany GmbH
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The clinical indications for using Igloo are limited by the limitations of each respective individual
qualitative, quantitative or semi-quantitative in-vitro lateral flow immunochromatographic or
colorimetric test.
The device can be used with various commercially available lateral flow tests and customized
cassette adapters.
Customized adapters are not included in the delivery but Experiment X may recommend their
preferred shape and manufacturing method.
You must calibrate the device to each test batch or test type before using it for test reading. The
calibration procedure needs an NFC-tag placed on the bottom of the cassette adapter.
The calibration procedure writes the test-specific data to the NFC tag, which the device will then
transfer wirelessly using near-field communication. The NFC-tag is not included in the delivery.
Symbols Used in this Manual
Caution
Safety warning
Consult User Manual
Manufacturer
In-Vitro Diagnostics
Date of manufacture
Degree of enclosure protection (IP Code)
Non ionizing electromagnetic radiation

Experiment X Germany GmbH
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Catalog number
Protection class of electronic equipment
European Conformity mark
Do not use if the packaging is damaged
Do not dispose with general waste. Please refer to
the country-specific rules and regulations.
Safety Information
Please follow the mandatory safety information supplied with Igloo.
Please read this chapter carefully before using the device.
Safety Instructions
When used properly, the device cannot adversely affect the life and health of patients.
Measurement results obtained using the device should always be analyzed by
professionals.
Results obtained using rapid tests should only be interpreted by professionals in
conjunction with other diagnostic procedures and clinical data to eliminate any false positive or
false negative results.
In case of any non-professional use, always check the test results with a physician.
Cautions
The device is equipped with a Li-ion battery. Do not heat it above the set temperature or
expose it to direct sunlight.

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The risk of electric shock is minimized but cannot be eliminated. Observe necessary
precautions when using electronic devices.
When used properly, the device cannot be a source of infection. However, contamination
due to the biological material being tested is possible. Always wear gloves and observe the
specific laboratory precautions.
Always follow the instructions in the in-vitro test’s manual and this user manual.
Use the device for its intended purpose only.
General Precautions
Be aware that liquids can cause irreparable damage to Igloo.
Do not clean Igloo with excess liquid and do not spray disinfectants directly onto or into it.
Considering these limitations, the device can only be cleaned with a disinfectant solution (e.g.
Mikrozid® AF Liquid, Aerodesin® 2000 or similar) applied to a cloth.
Do not expose the device to strong electromagnetic radiation. This may cause data to be
lost.
Protect the device from dust as it can damage some of its parts and affect test results.
Do not heat the device above the set temperature and do not freeze.
Use the device with the supplied cable and with a recommended charger only. Using
chargers that are not recommended may cause the device to malfunction.
Do not disassemble the device, otherwise the warranty will be automatically voided.

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Do not insert non-intended tools or any other objects into the device slot, as they may cause
the device to malfunction.
The device is not shockproof. Be careful as the device case is smooth enough for it to slip
out.
The device is intended for use outside of the human body. Do not insert body parts into the
device.
The device is resistant to movement, but the manufacturer does not recommend shaking
the device.
All in-vitro test measurements need to be done on a horizontal surface. Do not move or
rotate the device during the measurement as this may cause its contamination or incorrect
measurement results.
Preparing a test cassette without following the instructions may lead to
incorrect test results.
The calibration data and other test-specific information is written on the NFC tag on the
underside of the test cassette adapter. Be careful not to mix up adapters from different test
batches or types.
Always check that you are using the appropriate cassette adapter with a specific test
cassette.
A test cassette from a test batch that the device is not calibrated with may negatively affect
the measurement result accuracy.
Prerequisites
You need no special training or special skills other than reading and adhering to this manual.

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You can only use Igloo with specially designed software applications for different types of users.
You will need an Internet connection to download the software and start using Igloo.
System requirements for PC:
Operating system: Windows 7 or later (32 or 64 bit) or macOS 10.10 or later
Processor: Intel Pentium 4 or later with SSE2 support
RAM: 1 GB or more
Free disk space: 1 GB or more
Video resolution: 1024 x 768 or higher
Installing, Upgrading and Configuring the Software
The software applications need to interact with Igloo in order to process the obtained data.
Install Dx Care on your computer or laptop.
The download link is https://support.Igloo.today/dxcare. You can also find it at the bottom of
the device and on the device’s packaging.
Dx Care is available for Windows and MacOS.
Carefully read the End-User License Agreement (EULA) shown at first application startup.
You may not use the product without accepting the End-User License Agreement.
Dx Care automatically installs the latest updates but the system may request your consent
depending on system settings.
Measurement results cannot be obtained without the application.
Dx Care uses your operating system’s date and time. This is important for storing test results
and usage logs.
If you have any problems with the software, reload or reinstall it. If the problem persists,
contact support and do not use the device until you receive further instructions.

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The manufacturer explicitly prohibits using Igloo with other applications or software.
Step-by-Step Instructions
The steps to start working with the device are the same regardless of the delivery package.
Before You Begin
Prepare a work area for your Igloo.
Place Igloo on a flat surface away from any liquids as they could damage the device.
The work area should have enough free space to be able to easily insert and eject
the test cassette adapter (cartridge).
For the initial startup, launch Dx Care and connect your Igloo to your computer via the supplied
USB-C cable.
To turn on your Igloo for further startups, either:
1. Connecting it via USB-C cable to your computer, OR
2. Pressing the touch button for 3 seconds. The LED lights’ brightness will gradually
increase during this time.
Upon every startup, Igloo will go into self-testing, its indicator rotating fast. The self-testing
process usually takes a few seconds.

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After a successful self-test, the device indicator will start to breathe slowly if the battery level is
sufficient or rotate slowly if it requires charging.
You can now start working with your Igloo.
If the self-test was unsuccessful, the device indicator will flare in red.
In this case, refer to chapter Troubleshooting below or contact support. Do not use the device
until the problem is cleared.
Measurement
Launch Dx Care and switch on your Igloo.
Select Control mode.
The device indicator will on breathe fast.
The application will prompt you to insert an adapter with the test cassette into the device.
Use gloves.
Prepare the test cassette following its instructions for use.
Igloo reads the incubation time and other important test information from the NFC-tag.
Prior to the measurement, make sure the NFC-tag is located on the underside of the cassette
adapter.
Incorrect preparation of the test cassette can lead to incorrect test results.
Place the test cassette into the cassette adapter with test strips facing up and insert them
together into the device slot according to the adapter direction. The sample well on the test
cassette must be facing the outside of the device.

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The device is intended for use with various cassette adapters, but the test cassette must
be suitable for the test cassette adapter.
Always check that you are using the appropriate cassette adapter with a specific test
cassette. A cassette adapter with an NFC-tag from another test batch or type can lead to incorrect
measurement results.
Dx Care starts the measurement, with the device indicator rotating and the application showing
the measurement progress.
If you have inserted the cassette adapter with the test cassette into the device before launching
the application, eject the adapter and insert it again.
The measurement process always starts with the countdown of the incubation time. Note
that this process cannot be undone or paused once started.
Do not eject the cassette adapter until the reading is complete. If you eject the adapter for
more than 10 seconds, the incubation time will be reset and the application will ask to start the
measurement again. In this case inserting of the same test may lead to incorrect measurement
results.
Do not disconnect the USB-C cable until the reading is complete as this may terminate the
measurement or lead to incorrect results.
Do not move the device during the measurement as this may cause the cassette adapter
to get ejected without your noticing it or lead to incorrect measurement results .

Experiment X Germany GmbH
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Upon successful measurement, the device indicator will stop rotating and star to breathe fast
while Dx Care retrieves the result from Igloo. Once done, the application will and show the
result on the screen.
If the test result is invalid or cannot be obtained from Igloo, the application will show an
appropriate message. In this case, use another test cassette to perform the test from the
beginning.
Remember that the test results can be false positive or false negative for a variety of
reasons. Make sure to always have professionals double-check the results obtained using the
device using approved comparable diagnosis technique.
The manufacturer does not recommend starting a measurement if the battery level is
below 9 %, as the device might run out of charge before the procedure is completed.
Nevertheless, the application will be warning about a critical battery level.
Eject the cassette adapter and remove the used test cassette.
A test cassette can only be used once.
Remember that the biological fluids introduced into the test cassette are classified as
infectious biological waste.

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Always follow the instructions for the correct disposal of used test cassettes.
Some lateral flow test manufacturers do not recommend evaluating test results after a
certain time (expiration time) has passed.
The device is reusable. To continue measurements, save or export the test result using the
application menu.
Dx Care will ask to insert a cassette adapter with a test cassette. To make another test, follow the
instructions above.
You can save the measurement result as a PDF, XLS or CSV file. When the measurement is
complete, close the application and switch off Igloo.
When saving or printing the result, make sure not to mix up the data between different
measurements. The manufacturer explicitly disclaims its responsibility for the correct placement
and safety of measurement results.
Device Indicator Legend
Color
Mode
Meaning
Cases
White
Fast
breath
Igloo needs your
attention or
action (also
check
notifications in
the application)
Insert or eject the cassette adapter
Measurement completed successfully
Measurement error
Reboot Igloo via Dx Care UI to apply firmware update
Update finished check the results in Dx Care
White
Fast
rotation
Igloo is busy
Measurement in progress
Igloo is self-testing its internal components
Firmware update in progress
White
Slow
rotation
Some
background
process
Battery is charging, nothing else is happening
White
Slow
breath
Igloo is ready,
nothing else is
happening
Battery is from 10% to 100%

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White
Flare
Connection
established
Igloo is connected and ready to work with Dx Care
Yellow
Flare
Battery is low,
please charge
Igloo is 'slowly breathing' and each 3rd breath is flaring
yellow: battery is from 1% to 10%
Red
Flare
Igloo can't make
measurements
Battery is below 1%, please reconnect cable and try
again
Self-test returned an error
Blank
Igloo is resting
Igloo is turned off or in Sleep mode
Cleaning, Turning off and Storing Your Igloo
In case the device has been contaminated, clean it with a disinfectant solution, such as Mikrozid®
AF Liquid, Aerodesin® 2000 or similar applied to a cloth.
To avoid biological contamination, follow the cleaning recommendations after each use.
After 10 minutes of inactivity, the device indicator becomes less bright. After 15 minutes Igloo
automatically goes into standby mode.
If you touch the device before this time has passed, the indicator will start breathing slowly and
the device will wait for a new interaction.
Another way to turn off the device is to press the touch button and hold it for 3 seconds. The
device indicator brightness will gradually decrease and the device will switch off after 3 seconds.
Always store the device out of the reach of unrelated people or children.
The manufacturer recommends storing the device in a closed medical cabinet or desk.
Troubleshooting
Please note, that Igloo with a set of lateral flow tests, is a single unit that is certified, produced,
distributed and supported by its Legal Manufacturer**.
You can normally find Legal Manufacturer** name and contact information on kit packaging,
additional sticker on Igloo bottom or via your distributor.

Experiment X Germany GmbH
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#
Issue
Causes and recommendations
1
The device does not
turn on.
Check the USB-C cable connection to your computer.
Сheck the type of the cable used.
Charge the device.
Use the reset button (see #6).
2
The application can't
connect to the device.
Сheck the type of the cable used.
Restart the application.
Use the reset button to reload the device (see #6).
3
The measurement does
not start.
The adapter wasn't inserted into the device correctly
or sufficiently –check the cassette adapter.
Check the NFC tag on the bottom of the cassette adapter
or review the Dx Care notification.
4
No measurement result
was obtained.
The adapter ejected before the measurement was complete,
repeat the procedure with new test.
The battery is insufficiently charged, connect the device via
USB-C cable, results will be taken from the device if the
measurement was finished.
5
Self-test error.
Contact support.
6
Igloo not responsive.
Use the reset button located on the rubber at the bottom of
the device.
Press the button, release and then push again within 5
seconds to reset Igloo to its factory firmware and settings.
7
Igloo behaves
incorrectly.
Other cases when you
want to reset Igloo to its
factory settings.
Push twice the reset button, located under the rubber at the
bottom of the device.
Press the button, release and then push again within 5
seconds to reset Igloo to its factory firmware and settings.
8
The device does not
turn off.
Disconnect the USB-C cable. Don’t press the touch button and
don’t connect to the device from within the application. After
15 minutes, the device will go into standby mode.

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Technical Specifications
The device is equipped with a Li-ion battery. Every device is shipped with a USB-C cable. The
device User Manual is provided in an electronic form.
Cassette adapters are not included*. The availability of the adapter in the delivery
package depends on the type of delivery.
Experiment X reserves the right to change the specifications at any time.
Technical Data
Device type
Igloo (model Igloo Reader)
SN
See type plate on the back of device
Test principle
The test is done by measuring of the different
colored lines (test and control) on a test strip.
The test lines are evaluated either
qualitatively by checking whether the test
band occurs at all or quantitatively / semi-
quantitatively by calculating the color intensity
according to the peak height or the surface
area under the peak curve. Both methods can
be are used to determine the analyte
concentration.
Measuring
time
Several seconds excluding incubation time
Power supply
Rechargeable Li-ion Battery
Voltage 3.7 Vn
Rated capacity 2000 mA
Accuracy
Limit of detection 0.99
Inter-reader CV 9.1
Intra-reader CV 6.6
Memory card
1 GB
Recommended
charger
(not included)
Type FW8002MUSB/05
Input 100-240V/50-60Hz/160-80 mA
Output 5V/1400 mA

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Environment
Working 5 –40°C, 20% to 80% RH (non-
condensing)
Storage 0-45, 20% to 80% RH (non-condensing)
Transportation - 10 - 60°C, 20% to 80% RH
(non-condensing)
Input power
5V, 1400 мА
Weight
Approx. 200g
Dimensions
Height: 91 mm
Width: 87,5 mm
Depth: 87,5 mm
Connection
USB-C cable (2.0 or higher) input power 5V,
min 1400 мА
Wi-Fi &
Bluetooth
Module
802.11 b/g/n, 2.4 GHz, powered up 100 mW
Issue date
Expiration
date
Warranty
One year (if the number of battery recharge
cycles will exceed 500 during the first year,
then warranty expires since the moment of
this event)
Scope of Delivery
Igloo device
USB-C cable
Test cassette adapter*
Lateral flow test name**

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a. Touch button (on the top)
b. Reset button (on the bottom)
Regulatory Information
Igloo is CE marked in compliance with the essential requirements of the following European
Commission (EC) Directives:
In Vitro Diagnostic Medical Devices Directive 98/79/EС
Restriction of Hazardous Substances Directive 2011/65/EU.
The disposal of Igloo must be carried out in accordance with Regulation 2002/96/EC.
Customer Support and Service Information
Igloo is maintenance free.
The device is designed to self-test every time it is turned on. The camera sensor automatically
calibrates at regular intervals throughout its life cycle.
If you will keep the device clean and handle it carefully without damaging its internal parts, the
device provides long-term and accurate measurements.

Experiment X Germany GmbH
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Igloo lifetime is limited and depends on the number of measurements or battery recharges
made. The manufacturer expects the lifetime of 2 years during normal use.
Igloo is anticipated to provide the expected performance for up to 500 battery charging cycles.
However, in order to optimize this number, the device should not be stored continuously without
being used for extended periods of time.
If stored for a long time, the Igloo should be fully charged, fully discharged and fully charged again
at least once every 90 days. Otherwise, the functionality of the battery is not guaranteed.
However, even in this scenario, no safety risks are anticipated.
The manufacturer guarantees the correct operation of the device in compliance with its
operating instructions and recommendations. The expiration of the warranty does not prohibit
the use of Igloo, the manufacturer is not responsible for the results obtained after the device
expiration.
More information is available at https://support.Igloo.today/dxcare
For additional information and support please contact: [email protected]
Igloo is powered by a Li-Ion 2000 mAh battery, please follow the internal regulations of your
country for the proper disposal of the device.
If returning the device to the manufacturer, make sure to disinfect it first. The appropriate
disinfection procedure can be found on the website.
The name and address of the device and software manufacturer:
Experiment X Germany Gmbh (c/o TRA Robotics Gmbh)
Perleberger Straße 42d
D-10559 Berlin / Germany
**The name and address of the Legal Manufacturer:
Copyright Information
All trademarks are registered.
Contents of this document can be changed by Experiment X without notice.
Reproduction or republication of this document is prohibited without written concern of
Experiment X.
Igloo Dx Care Instructions for Use Document Version 1.0.1.