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.
14
Benefits-Risk determination
Based on the presented known benefits and the residual severity and probability of the identified
risks we determine EmbracePlus residual risks are outweighed by the potential benefits
EmbracePlus Materials & Biocompatibility
EmbracePlus components
EmbracePlus components relevant to the biocompatibility of the device are presented in the
table below. This table presents the part name, the quantity per device, the manufacturing
material and the manufacturing process.
Part Name
Qty
Material
Production Method
POD Case
1
Polycarbonate
Injection molding
Thermal Ring
1
Stainless Steel 316L
Lathe
PPG window
1
Gorilla Glass
Molding and Ion-exchange
POD Buttons
2
Stainless Steel 316L
Lathe
EINK Display
1
Gorilla Glass
Molding and Ion-exchange
Strap
1
Silicon
Injection molding
EDA electrodes
2
Stainless Steel 316L
Lathe
Buckle
1
Stainless Steel 316L
Lathe
OWC housing
1
Polycarbonate
Injection molding
OWC Cap
1
Polycarbonate
Injection molding
Biocompatibility information
Empatica takes great care in selecting the highest grade materials when designing its devices, so that users
have the most secure and comfortable experience when using them. It is therefore unlikely that users will
develop an allergic reaction from EmbracePlus. However, some people may notice a slight reaction on their
skin. If this happens, please contact our support team with a picture of the affected area(s).
Important Note: EmbracePlus should only be worn on the surface of healthy skin. We advise the user to
suspend or discontinue use if the skin becomes red, itchy or if any pain is felt. Without regular cleaning skin
irritation is more likely to occur, so Empatica suggests the user to clean EmbracePlus regularly. If the user is
allergic or hypersensitive to the materials listed in the above table we don't recommend using EmbracePlus.