User's Manual
Table Of Contents
- Glossary
- Product Description
- Regulatory and Compliance
- EmbracePlus product labeling
- EmbracePlus laboratory testing
- EmbracePlus Symbols used in labeling
- Intended use
- Indication for use statement
- Intended population and use environment
- Patients population and Medical Conditions
- Essential Performance Statement and Safety Information
- Service Life
- Limitations
- Warnings and Precautions
- Risks and Benefits
- EmbracePlus Materials & Biocompatibility
- Technical Specifications and Performance Characteristics
- Storage and Use Conditions
- Dust and Water Resistance
- Compatibility with MR and X-ray Scanning
- EMC Environment
- Getting started with EmbracePlus
- Troubleshooting
- Privacy
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.
10
• Rest Detection.
EmbracePlus is intended for temperature monitoring where monitoring temperature at the
wrist is clinically indicated.
Intended population and use environment
EmbracePlus is intended to be used by general population (age 2 and up) that want/need to
monitor their physiological parameters at home or in healthcare environments. Physiological
Parameters might be reviewed by Caregivers or Healthcare providers.
Patients population and Medical Conditions
User population
• Age: from 2 years of age (there might be limitation of wrist circumference for the
wearable device) to elderly
• Weight: not relevant, but there might be limitation of wrist circumference
• Health status: not relevant since EmbracePlus is not intended to be a primary diagnosis
tool
• Nationality: not relevant
• Patient status: the patient is often the same as the operator and is should be willing and
capable of managing its use
Caregiver population
• Healthcare professionals
• occupational doctors
• nurses
Essential Performance Statement and Safety Information
EmbracePlus Essential Performance: EmbracePlus shall be able to continuously collect, via
specific sensors, user’s physiological parameters and transfer them to the paired smartphone
without being corrupted or lost. The maximum allowed quantity of data not being collected or
loss during the normal use of the device is 5% of the duration of an acquisition session. An
acquisition session is defined as a time period during which the user is correctly wearing a device
with the purpose of acquiring data for reaching its intended use.
Evaluation of missing data is performed via specific data portal by an healthcare professional.
The connection between EmbracePlus and the paired smartphone can be lost for a maximum of
5% of the time but the device should be able to automatically reconnect to the paired
smartphone.
The entire device is considered as an “Applied Part”.
EmbracePlus users shall be considered “Operators” in the meaning of IEC 60601-1
EmbracePlus users can safely use all the EmbracePlus functions.