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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IP 67
Indicates that EmbracePlus is
classified as IP67 - resistant to
submersion in 1 m (about 3.3 feet) of
water for up to 30 minutes
Keep in dry conditions and away from
rain
Indicates the device Lot Number
Indicates the minimum and maximum
temperature at which the
EmbracePlus shall be stored
Indicates the minimum and
maximum pressure at which the
EmbracePlus shall be stored
Indicates the minimum and maximum
humidity at which the EmbracePlus
shall be stored
Indicates the need for the user to
consult the EmbracePlus instruction
for use for important information,
warning and cautions
Indicates the web address at which the
device instruction for use can be found
Intended use
EmbracePlus is intended to collect, process with embedded AI/ML algorithms, store, transfer
and remote monitoring of the following physiological parameters: Pulse Rate, Pulse Rate
Variability, Respiration Rate, Temperature, SpO2, Electrodermal Activity (EDA) and Rest
Detection.
EmbracePlus is intended for temperature monitoring where monitoring temperature at the wrist
is clinically indicated.
Indication for use statement
EmbracePlus is intended for continuous patient monitoring of patients (age 2 and up) in
professional healthcare facilities, such as hospitals or skilled nursing facilities, or in their own
home. EmbracePlus collected data are intended to be used for patient monitoring by trained
healthcare professionals only.
EmbracePlus is intended for continuous monitoring of the following physiological parameters in
ambulatory patients who are 2 years of age or older :
• Pulse Rate;
• Pulse Rate Variability;
• Respiratory Rate;
• Temperature;
• SpO2;
• Electrodermal Activity (EDA); and