Empatica EmbracePlus Instructions For Use Manual page 119

Essential Performance Statement and Safety
Information
EmbracePlus Essential Performance: EmbracePlus shall be able to
continuously collect, via specific sensors, the user's physiological
parameters and transfer them to the paired companion app/system
without being corrupted or lost. The maximum allowed quantity of data
not being collected or lost during the normal use of the device is 5% of
the duration of an acquisition session. An acquisition session is defined
as a time period during which the user is correctly wearing a device with
the purpose of acquiring data for reaching its intended use.
Evaluation of missing data are performed via a specific data portal by a
healthcare professional.
The connection between EmbracePlus and the companion app/system
can be lost for a maximum of 5% of the time, but the EmbracePlus
should be able to automatically reconnect to the companion app/system.
The entire EmbracePlus is considered as an "Applied Part".
EmbracePlus users shall be considered "Operators" in the meaning of
IEC 60601-1.
EmbracePlus users can safely use all the EmbracePlus functions.
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