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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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 – no significant harm – EmbracePlus has been designed, developed
and manufactured using state of the art techniques, in addition electromagnetic compatibility tests have
been performed according to relevant regulatory requirements.
EmbracePlus Environmental conditions - including any hazard that might result from the storage or use
of EmbracePlus in extreme environmental conditions.. Low risk level – no significant harm – EmbracePlus
has been designed, developed and manufactured using state of the art techniques and materials that can
withstand a wide range of environmental conditions. Indication of the environmental conditions in which
the device shall be stored and used are presented in this manual.
EmbracePlus Usability - including any hazard that might result from the use errors or design failure. Low
risk level – no significant harm – EmbracePlus user interface and user experience has been designed and
tested following relevant regulatory requirements. Moreover EmbracePlus labeling documents contain all
the relevant information for a flawless use of the device.
EmbracePlus Cybersecurity - including any hazard that might result from data corruption and loss of data
confidentiality. Low risk level – no 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 benefit 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
● The Remote monitoring capabilities of EmbracePlus could alleviate the burden to the
healthcare system by providing an additional option for remote monitoring of
hospitalized users to minimize in-person interactions. Healthcare workers are at
particular risk of infections transmission, especially when conducting procedures that
require direct user contact, such as taking vital signs. Remote monitoring practices can
reduce the risk of transmission.