Empatica EmbracePlus Instructions For Use Manual page 121

Moreover, the EmbracePlus is not intended to diagnose a disease; only
trained personnel may interpret the data.
EmbracePlus Cleaning - including any hazard that might result from
wrong cleaning procedure or use of non-compatible cleaning agents.
Low risk level – no significant harm – State of the art validation protocols
have been performed to validate EmbracePlus cleaning procedure and
listed cleaning agents.
EmbracePlus Biocompatibility - including any hazard that might result
from use of non-biocompatible construction material. Low risk level – no
significant harm – EmbracePlus is made of a well-known biocompatible
material, biocompatibility tests have been performed according to
relevant regulatory standards.
EmbracePlus Safety - including any hazard that might result from
electrical and mechanical failure. Low risk level – no significant harm –
EmbracePlus has been designed, developed, and manufactured using
state of the art techniques. In addition, safety tests according to relevant
regulatory requirements have been performed.
EmbracePlus Electromagnetic Compatibility - including any hazard
that might result from internal or external interferences. Low risk level –
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