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they are supervised by an individual responsible for their safety or receive instructions from the latter as to how the
device should be used.
4. Intended Use as a Medical Device (Medical Device Version Only)
1. The Skiin Underwear is intended for users 18 years of age or older, through over the counter or prescribed by a
healthcare provider to record and monitor continual ECG data usable for a 3rd party reporting tool at static positions
and shared with their circle of care, which includes skilled medical professionals.
2. The Skiin Underwear is intended for users 18 years of age or older, through overthe counter or prescribed by a
healthcare provider to record and monitor continual ECG data usable for a 3rd party reporting tool at static positions
and shared with their circle of care, which includes skilled medical professionals. The ECG viewer is to confirm the
presence of signal and not to be used for diagnostic purposes
Circle of care consists of the user’s trusted connections who have an interest in the user’s health or wellbeing, for
example, family members, friends, or health care professionals.
5. Safety Information
Before using the Skiin Underwear system, please become familiar with the information in this Operation and Safety
Manual and the Quick Start Guide.
Failure to follow safety instructions and/or using the equipment for purposes other
than those described in Skiin Underwear Labeling constitutes improper use.
Information pertaining to the use of the Skiin Underwear system to perform the biomonitoring
WARNING
EN-W2
NOTE
EN-N2