Bloom Diagnostics Lab, Инструкция по эксплуатации, Страница: 5 / 56

5
EN
5
1 x Capillary
tube (lithium
heparin)
for blood
collection
Sarstedt AG &
Co., Nümbrecht,
Germany
6 1 x Buffer
7
1x Disinfecting
cleaning wipe
for Bloom Lab 0123
B. Braun Medical
AG, Sempach,
Switzerland
Caution: Do not use equipment other than that specified
by Bloom Diagnostics to guarantee the proper function of
the device.
3. Safety Regulations
3.1. Disclaimers
• Do not take the Bloom Thyroid Test if you are under 18
years old, pregnant or have given birth in the past 12
months, have or have had thyroid cancer or pituitary
adenoma, or if you find yourself in an acute situation of
emergency or distress. In case of doubt, always consult with
your medical practitioner.
• The Bloom Report displays the result of the Bloom Thyroid
Test and additional information. It is not intended to diag-
nose or inform about the treatment of medical conditions.
Never avoid, put off, change or start treatment based on the
content of the Bloom Report. In order to receive a diagnosis
and treatment, consult a medical practitioner. In case of
health concerns seek medical attention immediately.
• With the exception of the measured test value, all infor-
mation presented in the test report is the result of Bloom
Diagnostics’ research conducted with literature available at
the time of development. All content provided is subject to
change depending on scientific discoveries and advances,
and might not apply globally. While the information in the
test report is provided with great care, Bloom Diagnostics
cannot guarantee its accuracy or completeness.
3.2. General notes on safety
• The validity of the Bloom Thyroid Report relies on the
correctness of the answers. Once submitted, the answers
cannot be modified.
• Do not use the Bloom Thyroid Test if you are under the
effects of alcohol or drugs.
• Do not perform multiple Bloom Tests at the same time. A
new test should only be started once the first has been fully
completed.
• Do not use the Bloom Thyroid Test in an environment with
high humidity, such as the bathroom.
• Unpack the individually sealed components of the Bloom
Thyroid Test directly before use.
• Do not use the Bloom Thyroid Test if its packaging or any
of its sub-packaging is damaged or show evidence of
tampering.
• The Bloom System 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 System. This includes using generic power
cables or uncertified or generic test strips.
• Never attempt to modify, deconstruct, damage, or tamper
with any elements of the Bloom System as this can result
in malfunction and will make the support service and
product’s warranty null and void. The Bloom Thyroid Test
should not be used when it is known to be malfunctioning,
broken, defective, or contaminated.
• The Bloom Lab and the entire Bloom System should only
be purchased from authorized retailers and never second-
hand.
• This device may be used by people with reduced mental
capabilities provided that they are supervised and are fully
aware of the subsequent risks of use.
3.3. Limitations of use
• This test can not be used for screening of hyperthyroidism
or secondary/tertiary hypothyroidism.
• Your TSH level might be below the device’s detection limit
of 2 mIU/L (normal reference range: 0.4-4.5 mIU/L).
Values below this limit are identified as “< 2 mIU/L”. See
“2.2.2. Test performance” for more information.
4. Operating steps
Always follow the Bloom System’s operating steps in a
sequential order.
Caution: When using the Bloom Thyroid Test containing
five tests:
• Keep the test packaging until you have performed all five
tests, in order to initiate a test.
• Ensure the test kit is only handled by one individual.