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The Tremipen® must NEVER be used for
self-diagnosis or self-therapy or for changes
to the medication without a medical
professional.
Contact your attending doctor if you receive
unexpected results, which are not caused by
technical or usability errors.
The Tremipen® must only be used as
described in this IfU! Do NOT manipulate
your tremor to get lower and/or higher
measurement results.
If you have an allergic reaction or skin
irritation while touching the Tremipen®, do
NOT touch the device anymore and contact
the Legal Manufacturer!
The Tremipen® must only be used within
the environmental conditions described in
this IfU! Otherwise this could lead to wrong
measurement results.
The Tremipen® is NOT a toy! Keep it away
from children due to swallowable parts.
(MDD, Attachment I, Chapter 2)
Adverse Effects:
Based on previous clinical evaluations
NO adverse effects were identified!
Residual Risks:
Based on previous clinical evaluations
NO critical residual risks were identified! Residual risks
concerning the use are defined in chapter 7.
6. Adverse Effects and Residual Risks
For a full list of applicable rules, laws and standards
see the Declaration of Conformity within this IfU
(page 1).
5.2 Rules, Laws and Standards applicable
for the Tremipen®
7. Safety Warnings and Risks
27
Содержание Tremipen
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