User's Manual

The information contained in this document is confidential and is the property solely of Empatica, S.r.l.. Any reproduction in part or in whole without
the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2021. All rights reserved.
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2. Empatica does not recommend wearing the device if you have a known allergy to metals,
or you are generally sensitive to skin contact with metals.
3. Keep EmbracePlus clean: bacteria and dirt may cause skin itching or irritation.
4. Do not leave EmbracePlus in environments in which it may overheat beyond the
recommended environmental limits (e.g., a car parked under the sun). If EmbracePlus is left
exposed to high temperatures, allow it to cool before handling it to avoid possible skin
burns.
5. Changes or modifications not expressly approved by the manufacturer could void the user’s
authority to operate the equipment.
6. Avoid using EmbracePlus in a hot tub, sauna or steam rooms.
7. Do not use the On-Wrist charger while showering or swimming.
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, use 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 use 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 sensors 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. 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.