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4 4-3-6-2 Bloom Lab IFU, 09.04.2020, V1.0 5 4-3-6-2 Bloom Lab IFU, 09.04.2020, V1.0
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• Warning: A warning points out a situation where a
potentially hazardous condition exists that could result
in a critical or catastrophic situation such as death or
serious long-term injury if not avoided.
• Caution: A caution points out a situation where a poten-
tially hazardous condition exists that could result in a
serious situation such as short-term injury or impairment
requiring medical intervention to correct if not avoided.
• Information: Information points out a situation where a
potentially hazardous condition exists that could result
in a non-serious situation such as a slight inconvenience
if not avoided.
4. Product information
The Bloom Lab only works together with the Bloom App and
Bloom Tests. These form the “Bloom System”. To get started,
download and install the Bloom App on your smartphone.
Warning
Do not use the Bloom System as a diagnostic
device. Using the information provided by the
Bloom System for diagnosis can lead to mis-
treatment and severe consequences. Results
should be reviewed by a medical practitioner.
4.1. Overview of the Bloom System
Bloom Test packaging
Bloom App
Bloom Test strip
Sample
window
Read out
window
NFC tag
Bloom Lab
LED indication ring Strip insertion flap
Bloom System
The Bloom System is a medical testing system. It provides
screening and monitoring of target markers and medical
guidance. It combines lateral fl ow immunoassays (Bloom
Test strips), an established diagnostics technology, with an
electronic reader for test strip analysis (Bloom Lab) and an
app for displaying and interpreting results (Bloom App).
4.2. Bloom Lab
The Bloom Lab is an electronic device, which contains
an optical measurement system to quantify the test line
intensities produced by the Bloom Test strip during use. The
Bloom Lab is intended to be used in combination with the
Bloom App and Bloom Tests. More information on this can
be found in chapter 5.
4.3. Bloom Lab components
Caution: Only use equipment specifi ed by Bloom Diagnos-
tics to guarantee the proper function of the device.
The Bloom Lab package includes (required):
• 1 x Bloom Lab
• 1 x Power supply (model no RYS518050150UE)
• 1 x USB-A to USB-C cable (150cm)
• 1 x Instructions for use
See the following images for reference.
Bloom Lab USB-C cable
Power supply Instructions for use
Not included (required):
• Bloom Test
• Bloom App
Visit www.bloomdiagnostics.com to learn more.
5. General operating steps
Caution: Exceeding or not meeting the specifi ed conditions
can cause damage to the device.
Caution: Do not use the Bloom Lab in rooms with high
humidity such as the bathroom, as this could lead to fail-
ures regarding the evaluation of the retrieved sample.
Caution: Do not use the Bloom Lab for self test without
proper guidance from a healthcare professional.
In order to use the Bloom System, you must have a smart-
phone with a working internet connection and the installed
Bloom App ready, as well as a Bloom Test. Check the Bloom
Lab package components for completeness and any damage
to the Bloom Lab.
such situations, false results may nevertheless be received.
Therefore, the user should not make any decision of medical
relevance based on the results received from the Bloom
System without fi rst consulting their medical practitioner.
When the Bloom System is used for tracking of existing
medical conditions, the user should only adapt their
treatment of that condition based on Bloom Test results
if they have been trained to do so or in conjunction with a
medical practitioner. Any treatment prescribed by a medical
practitioner might require additional independent testing by
a medical practitioner and/or laboratories.
2.2. General notes on safety
Do not use the Bloom Lab if you are under 18 years of age, if
you are, or may be, pregnant, if you are intoxicated, or if you
fi nd yourself in an acute situation of emergency or distress. In
case of doubt, always consult (with) your medical practitioner.
Use of accessories, transducers and cables other than those
specifi ed or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in improper operation.
Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that
they are operating normally.
Do not use the device after rapid temperature or humidity
change in the environment as this could lead to an incorrect
interpretation of your results. Please leave the device without
power after rapid external temperature/humidity change.
The Bloom Lab is limited to indoor use.
If the Bloom Lab is used in a manner not specifi ed by the
manufacturer, the degree of protection provided by the
Bloom Lab may be impaired.
2.3. How to handle the Bloom Lab correctly
In order to avoid hazardous situations, the Bloom Lab
should be handled with care at all times, this includes:
• The Bloom Lab should not be:
– exposed to direct sunlight, physical instability, humidity,
moisture, rapid temperature changes, strong electric/
magnetic fi elds, strong power surges, dirt or dust;
– exposed to high impact, as a result of falling or otherwise;
– compressed or have weight placed upon it from any direction;
– handled with force or pressure;
– exposed to vibrations, movement or extreme changes in
air pressure while in usage;
– disassembled, except by trained and certifi ed Bloom
Diagnostics’ technical support staff ;
– modifi ed.
• The Bloom Lab should be used in the temperature range
b15°C to +40°C;
• The Bloom Lab should not be used with any hardware or
software that is not manufactured or developed by Bloom
Diagnostics for the explicit purpose of being used with the
Bloom Lab. This includes using generic power cables or
uncertifi ed or generic strips;
• Bluetooth® connection or power supply should not be
disconnected or lost while measurement, pairing, or usage
of the Bloom Lab is ongoing.
2.4. Handling of bodily fl uids
All bodily fl uids should be treated as potentially infectious.
If the Bloom Lab comes into contact with bodily fl uids
either from you, or from other people using the Bloom Lab,
including family members and friends, you should use the
provided Softa Cloth CHX 2% cleaning wipe to disinfect the
Bloom Lab and any other surface that may have come into
contact with bodily fl uids.
2.5. Use of second-hand Bloom products
The Bloom Lab and entire Bloom System should only be
bought from authorized retailers and never second-hand.
2.6. Use of non-Bloom parts with the Bloom
System
The Bloom System should only be used with products speci-
fi ed by Bloom Diagnostics.
2.7. Damaged products or packaging
Do not use Bloom products, including all elements of the
Bloom System, if the products or their packaging appears
damaged or shows evidence of tampering.
Do not attempt to deconstruct, damage, or tamper with any
element of the Bloom System as this can result in malfunc-
tion and will void the product’s warranty.
3. Terms and defi nitions
Safety notes: Safety-related information that warns users
about hazards and instructs on how to avoid them: