Safety Manual

6
Operators of the system will be able to benet from the Skiin Underwear system’s non-invasive form factor and ability
to record connual data which can be analysed for cardiac abnormalies.
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The essenal performance of the Skiin Underwear system is the ability to monitor and export ECG raw data to
generate an accurate report of the paent’s ECG through a 3rd party tool.

The Skiin Underwear is indicated for users in need of remote monitoring and aiding the idencaon of potenal
cardiovascular issues by skilled medical professionals through a 3rd party reporng tool. The medical features for ECG
monitoring of this product are not to replace tradional methods of diagnosis or treatment. Wellness features such as
acvity, temperature, respiraon rate, sleep quality, mood and stress and not indicated to use as a medical device.
Contraindicaons
The Skiin Underwear is not for use by:
• Persons under 18 years of age
• Pacemaker and/or (ICD) implantable cardioverter debrillator users
• Pregnant Women
This device is not intended for use by children. Do not leave the device near babies, infants or children. This device is
not intended for use by individuals with limited physical capacies or limited experience and / or knowledge unless
Risks for children and individuals requiring assistance