Empatica EmbracePlus User manual

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
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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
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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
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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.
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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.
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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
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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
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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

Symbol
Description
Symbol
Description
Empatica Health Monitoring
Platform is a prescription only
device
LIST OF ABBREVIATIONS AND TERMS
Within this document the following abbreviations and terms are used
Abbreviation/Term
Meaning
ECG
Electrocardiogram
EMC
Electromagnetic Compatibility
ICU
Intensive Care Unit
LED
Light Emitting Diode
RF
Radiofrequency
SpO2
Blood Oxygen Saturation
BLE
Bluetooth Low Energy
Administrator(s)
Throughout this document the term administrator(s) is
used to identify healthcare professional and researchers
using the product
User(s)
Throughout this document the term user(s) is used to
identify patient(s) and clinical trial participant(s) using the
product and whose physiological parameters are being
monitored.
Companion app/system
Throughout this document the term companion
app/system is used to identify the mobile app (e.g., Care
App) installed on the user’s companion device that receive
EmbracePlus data via BLE connection
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DOCUMENT HISTORY
Revision
Date
Description
1.0
April, 2022
Initial release of the document
2.0
June, 2022
Update of links and layout
Safety consideration
To support proper, safe, and accurate operation of the product, read all
operating instructions carefully before you use the product.
WARNING: To maintain user safety, adhere to all WARNING and CAUTIONS listed
in these Instructions for Use and on product labels
WARNING: No modification of the product is allowed. Modification of this product
may cause interference with other devices, injury to patient and user including
electric shock, burns or death.
WARNING: Do not operate the product in areas such as magnetic resonance
imaging (MRI) environments, while taking an X-Ray or in hyperbaric chambers.
Do not operate EmbracePlus in close proximity (12 inches/30 cm) to portable RF
communication equipment, including antennas, since they may interfere with
device operation.
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WARNING: Risk of infection. Empatica technical staff can become infected with
pathogenic germs. Disinfect and clean EmbracePlus before returning the medical
device to Empatica.
WARNING: If EmbracePlus is used in a manner not specified by the manufacturer,
the protection, functionalities, and performance they provide could be
compromised.
WARNING: EmbracePlus and any other applied parts should be removed prior to
patient defibrillation.
CAUTION: Read all cleaning instructions carefully before cleaning EmbracePlus.
Refer to
the cleaning and disinfecting chapter of the instructions for use.
12

EmbracePlus disposal
WARNING: Risk of infection. EmbracePlus must be disinfected and cleaned before
disposal
WARNING: EmbracePlus contains a lithium-ion battery. Do not incinerate the
device or place it in a trash compactor. Do not puncture the battery
When disposing of EmbracePlus please return it to Empatica and
observe all applicable laws and regulations.
Its return to Empatica will be arranged via Empatica Support.
This medical device is subject to the EU Directive 2012/19/EU (WEEE).
It may not be disposed of at municipal collection points for waste
electrical and electronic equipment.
13

Cybersecurity
GENERAL
Empatica has taken significant steps to protect its product from
cyberattacks, but the user has a crucial role in maintaining cybersecurity.
The guidelines in this section must be followed.
Empatica’s EmbracePlus is connected to the user’s companion device,
where the companion app/system is installed, through a Bluetooth Low
Energy connection.
Communications between the EmbracePlus and the Care App are
encrypted using the 128-bit AES-CCM encryption standard.
Empatica’s Care App can be installed on an iOS device running iOS
version 11 or higher, or an Android device running Android version 8
(Oreo) or higher. As Apple reviews every application before it is allowed
on the Apple App Store, the iPhone is very resilient to cyberattacks. The
Google Play store reviews applications for the Android platform. No
protected health information is stored in the mobile device’s local
storage.
All communications between the Care App and the Empatica Care
Portal are encrypted to an industry-standard. Communication between
14

the Care App and the Care Portal takes place through a cellular data
connection or WiFi, based on user preference.
CLOUD AND NETWORK DEPENDENCIES
Empatica’s Care App can only transmit physiological parameters to the
Care Portal if there is an active cellular data connection or WiFi. The
Quality of Service of this connection is determined by your cellular plan.
Data transfer to the Care Portal might be delayed in case of poor cellular
coverage, WiFi issues or limited cellular data plan.
In case of missing cellular data or Wifi connection, or in the rare event of
the unavailability of Empatica’s servers, you should continue to wear
EmbracePlus and use the Care App as your physiological parameters will
continue to be collected. You shall promptly solve the underlying issue
causing the absence of cellular data or WiFi connection. Once cellular
data or the WiFi connection is restored, the collected data will be
transmitted to the Care Portal. Empatica’s servers reside on an AWS
infrastructure that guarantees an uptime of our cloud infrastructure >
99.95%.
PASSWORD POLICY, PASSWORD EXPIRATION AND
AUTO-LOGOUT
A combination of username and password are used to control access to
the Care App.
15

Your username and password have been provided to you by the
operating institution in a document called “participant credentials”. As a
user of EmbracePlus and the Care App, you do not have the possibility
to change or reset your password. If you are disconnected from the Care
App and you are not able to find your “participant credential”, contact
the operating institution to receive new credentials.
SOFTWARE UPDATES AND PATCHES
On iOS and Android, the Care App should be updated as soon as a new
version becomes available. When a new version becomes available, the
Care App will notify the user through a specific on-screen notification.
Clicking the notification will access the Apple App Store in the case of
iOS or the Google Play Store in the case of Android, where the
up-to-date version can be downloaded.
EmbracePlus firmware should be updated as soon as a new version
becomes available. When a new version becomes available, the Care
App will automatically update the EmbracePlus firmware if the
companion device has cellular data or WiFi connection. The firmware
update process will take approximately 30 seconds, during which
EmbracePlus will not collect data. As soon as the update is completed,
EmbracePlus will restart and data collection will resume. No user
interaction is needed during the firmware update process.
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DEALING WITH A LOST OR STOLEN EMBRACEPLUS WEARABLE
DEVICE
In case an EmbracePlus medical device is lost or stolen, please notify
your administrator, providing your username.
General guidelines for security
• It is recommended that any mobile device with the Care App installed
also has a device passcode set.
• You should never disclose your Care App username or password.
• You should never write down your Care App username or password.
• You should never provide access to the Care App to an unauthorized
user.
• You should never leave the mobile phone with the Care App installed
logged in and unattended.
• You should never connect the mobile device where the Care App is
installed to a public WiFi.
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EmbracePlus
EmbracePlus User Manual English
18

Index EmbracePlus
1. EmbracePlus at a glance 22
2. Using EmbracePlus for the first time 27
3. Using EmbracePlus in daily life 35
4. Troubleshooting 50
5. FAQs 56
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