Service Life
EmbracePlus expected service life is 2 years.
Risks and Benefits
RISKS
The list below represents all aspects that should be considered as
cautions resulting from the Risk Management Process of the
EmbracePlus. The user is required to carefully read this manual before
using the device.
Physiological Parameters presence and quality -
including any hazard
that might result from sensors failure, electrical components damage,
user errors or low algorithm performance. Low risk level – no significant
harm – On-board memory, state of the art electrical design, fault
detection algorithms and clear user experience have been implemented
to mitigate the risk. Moreover, the EmbracePlus is not intended to
diagnose a disease; only trained personnel may interpret the data.
Physiological Parameters computation
- including any hazard that
might result from sensor failure or low algorithm performance. Low risk
level – no significant harm – State of the art validation protocols have
been performed to validate EmbracePlus physiological parameters.
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