If the update is interrupted due to an interruption of power, contact
“Customer service” on page 16).
Risk of damage to the device from condensation!
– Only use the device in a dry environment.
– Never store the device in damp places.
– Let the device acclimatize in the event of location changes.
– In the event of faults, immediately disconnect the device
from the power supply and notify Customer Service
(
“Customer service” on page 16).
– Never switch on the device if condensation is visible.
Condensation can form in the event of changes in humidity
and temperature. Moisture in the control unit can result in
damage or even total destruction.
2.6 Reporting of adverse events
MedWatch is the Food and Drug Administration's (FDA) program
for reporting serious reactions, product quality problems, thera-
peutic inequivalence/failure, and product use errors with human
medical products, including drugs, biologic products, medical
devices, dietary supplements, infant formula, and cosmetics.
If you think you or someone in your family has experienced a
serious reaction to a medical product, you are encouraged to take
the reporting form to your doctor. Your health care provider can
provide clinical information based on your medical record that can
help FDA evaluate your report.
However, we understand that for a variety of reasons, you may not
wish to have the form filled out by your health care provider, or
your health care provider may choose not to complete the form.
Your health care provider is not required to report to the FDA. In
these situations, you may complete the Online Reporting Form
yourself.
You will receive an acknowledgement from FDA when your report
is received. Reports are reviewed by FDA staff. You will be person-
ally contacted only if we need additional information.
Use one of the methods below to submit voluntary adverse event
reports to the FDA:
Condensation
NOTICE
MedWatch (FDA)
Submitting adverse event reports
to the FDA
Safety
2021-07-28
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