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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Performance Characteristics 15
Technical Specifications 16
Data Collection Specifications 18
Sensors Configuration 18
Data Flow and Access 19
Sensors Raw Data Specifications 20
Storage and Use Conditions 22
Dust and Water Resistance 22
Compatibility with MR and X-ray Scanning 23
EMC Environment 23
Guidance and Manufacturer's declaration - electromagnetic emissions 23
FCC Compliance 23
Guidance and Manufacturer's declaration - electromagnetic immunity 24
Recommended separation distance between portable and mobile RF communications
equipment and EmbracePlus 24
Getting started with EmbracePlus 26
How EmbracePlus works 26
What EmbracePlus comes with 27
How to wear EmbracePlus 28
Charging EmbracePlus 28
How to correctly position the OWC on the EmbracePlus 29
Setting up EmbracePlus 30
Maintenance & Cleaning of EmbracePlus 31
EmbracePlus does not need particular inspections, maintenance or calibration to reach its
intended performances. Good general care shall be taken when using the device to avoid
involuntary damages such as falling or crash damages. 31
Cleaning of the EmbracePlus 31
EmbracePlus User Interface Guide – Frequently used functions 32
On-Wrist Charger LEDs guide 35
How to safely dispose of EmbracePlus 35