Empatica EmbracePlus Manuel utilisateur
Patient
Instructions for use
Empatica Health Monitoring Platform
Patient instructions for use English | UM-74 | Rev 2.0, June 2022
Content
—
Introduction
Intended use
Indication for use statement
Documentation features
Safety considerations
EmbracePlus disposal
Cybersecurity
EmbracePlus user manual
Care App user manual
Empatica support center
Technical specifications & Performance characteristics
Safety & Precautions
Regulations & Compliance
1
Introduction
The Empatica Health Monitoring Platform is a wearable device and
paired mobile and cloud-based software analytics platform intended to
be used by trained administrators to remotely monitor physiological
parameters in ambulatory users in home-healthcare and professional
healthcare environments.
Hardware component
The Empatica Health Monitoring Platform consists of the following
hardware components:
EmbracePlus – wearable medical device
(Class II, Type BF Applied Part)
Cable charger
2
Software component
The system has two software components:
CARE APP
Available on:
Apple iPhones 8 or higher running iOS 11 or higher
Android smartphones running Android 5 or higher
Note that the Care App is identical on both iOS and Android. As such, the
processes explained below are the same across both platforms.
CARE PORTAL
Available on:
Chrome version 86.0.4240 or higher
Firefox version 81.0 or higher
Safari version 14.0 or higher
Edge version 85.0.564
3
WARNING: To properly use this medical device, read and comply with these
instructions for use
CAUTION: USA Federal law restricts this device to sale by or on order of a physician
Intended use
The Empatica Health Monitoring Platform is intended for the remote
monitoring of physiological parameters, whose variation could not result
in immediate danger to the patient.
The Empatica Health Monitoring Platform is intended to be used in
ambulatory users* in healthcare facilities and home settings.
The Empatica Health Monitoring Platform is intended for the
retrospective review of the collected physiological parameters.
The Empatica Health Monitoring Platform is not intended to be used by
acutely ill cardiac patients with the potential to develop life-threatening
arrhythmias or to be used in high-acuity environments such as an ICU or
operating room.
*Users' minimum age varies based on the country. The minimum is 2 years and up in the EU, and 18
years and up in the US.
4
Indication for use statement
The Empatica Health Monitoring Platform is a wearable health monitor
and paired mobile and cloud-based software analytics platform intended
to be used by trained healthcare professionals or researchers to
remotely monitor physiologic parameters in ambulatory users in
home-healthcare and professional healthcare environments.
The device supports continuous monitoring of**:
• Pulse Rate,
• Oxygen Saturation,
• Peripheral Skin Temperature, and
• Electrodermal activity
as well as intermittent monitoring of:
• Respiratory Rate, and
• Pulse Rate Variability
during periods without any motion.
Activity sensors are used to detect sleep periods and monitor the
activity associated with movement during sleep.
The Empatica Health Monitoring Platform can be used to analyze
circadian rhythms and assess activity in any instance where quantifiable
analysis of physical motion is desirable.
5
The Empatica Health Monitoring Platform is also intended for use by
third-party solution integrators to build: mobile applications, monitoring
systems, web-based solutions to enable healthcare professionals to
review and analyze the collected physiological parameters. When
integrated into these medical devices, the manufacturer will identify the
indication for use depending on the application of their device.
The Empatica Health Monitoring Platform is not intended for use in
high-acuity environments, such as an ICU or operating room.
The Empatica Health Monitoring Platform is not intended for use on
acutely ill cardiac patients with the potential to develop life-threatening
arrhythmias.
The Empatica Health Monitoring Platform is not a substitute for an ECG
monitor and is not intended for diagnostic purposes or to be used as the
sole basis for clinical decision-making.
The Empatica Health Monitoring Platform is not intended for oxygen
saturation (SpO2) monitoring in conditions of high motion or low
perfusion.
The Empatica Health Monitoring Platform is not intended for
Respiratory Rate and Pulse Rate Variability monitoring in motion
conditions.
The Empatica Health Monitoring Platform is not intended for
Respiratory Rate monitoring in professional healthcare environments
6
The Empatica Health Monitoring Platform is not intended for use in
calculating Pulse Rate Variability in patients that are or might be
affected by cardiovascular diseases.
The Empatica Health Monitoring Platform does not include and is not
intended for automated arrhythmia analysis.
The Empatica Health Monitoring Platform provides PRV as the
root-mean-square of successive differences (RMSSDs) between
consecutive systolic peaks detected on the PPG signal, in milliseconds.
**Depending on sensor configuration
7
Documentation features
WARNING AND CAUTIONS
WARNING: A WARNING statement provides important information about a
potentially hazardous situation which, if not avoided, could result in death or
serious injury.
CAUTION: A CAUTION statement provides important information about a
potentially hazardous situation which, if not avoided, may result in minor or
moderate injury to the user or patient or in damage to the equipment or other
property
SYMBOLS USED IN LABELING
Symbol
Description
Symbol
Description
Indicates compliance with the
European Medical Device
Directive 93/42/EEC. 0051 is
the identification number of the
Notified Body responsible for
the CE Certification Process
Indicates Empatica S.r.l as
the legal manufacturer of
EmbracePlus
Indicates that the
electromagnetic interference
from the EmbracePlus is under
the limits that are approved by
the Federal Communications
Commission
The EmbracePlus uses
Bluetooth Low Energy to
transfer data.
EmbracePlus is an electrical
and electronic equipment and
needs separate collection for
disposal in accordance with
Waste Electrical and Electronic
Indicates the device
Serial Number
8
Symbol
Description
Symbol
Description
Equipment Directive
EmbracePlus has two metal
contact points that are used by
the EDA sensor. This is type BF
part which means that it may
generate a leakage current
when in contact with the skin.
ISO 60601-1 safety test
demonstrated that this part is
safe.
Indicates the need for the
user to consult the
EmbracePlus instruction
for use for important
information, warning, and
cautions
Indicates that EmbracePlus
intentionally generates RF
signals for data transmission to
a connected device.
Indicates the
manufacturing date of
the device
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
9
Autres manuels pour EmbracePlus
2
Table des matières
Autres manuels Empatica Équipement médical
