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.
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Getting started with EmbracePlus
How EmbracePlus works
EmbracePlus physical device is worn on the user's wrist and continuously collects raw data via its
sensors installed on the device body, named POD, or on the device strap. EmbracePlus is
equipped with the following sensors:
● EDA (Electrodermal Activity)
● PPG (Photoplesmography)
● Accelerometer
● Temperature
The collected data is elaborated quasi-realtime by a set of specific algorithms and models
onboarded on the device firmware, the results of the algorithms are specific physiological data.
The algorithms and models available for EmbracePlus will be:
• Pulse Rate;
• Pulse Rate Variability;
• Respiratory Rate;
• Temperature;
• SpO2;
• Electrodermal Activity (EDA); and
• Rest Detection.
All these algorithms are included in a system component called EmpaDSP.
The elaborated data will be further elaborated to make them sendable to a mobile device using
BLE protocol. The mobile device paired with the EmbracePlus device will have a specific
compatible mobile application installed that will receive the data and show them to the user. This
compatible mobile application will also send the data via mobile device data connection to a
specifically developed Backend (Cloud) where the data will be unpacked and further elaborated
if requested by specific algorithms.