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Empatica EmbracePlus - Page 121

Empatica EmbracePlus
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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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