Empatica EmbracePlus Instructions For Use Manual page 123

significant harm – EmbracePlus software architecture includes state of
the art controls to ensure data integrity.
EmbracePlus Functionality - including any hazard that might result from
failures in device functionalities. Low risk level – no significant harm –
EmbracePlus functionalities have been designed, developed, and tested
using state of the art techniques.
BENEFITS
The known and potential benefits of EmbracePlus for clinical use are:
● The Remote monitoring capabilities enabled by EmbracePlus could
reduce the caregivers' risk of exposure to potential health risks.
● Facilitate users' remote health status control without the need of
hospitalization.
BENEFITS-RISK DETERMINATION
Based on the presented known benefits and the residual severity and
probability of the identified risks, we determine EmbracePlus residual
risks are outweighed by the potential benefits.
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