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.
8
● IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices
● ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a
risk management process
● EN ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
● ISO 10993-10: 2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin
sensitization
● FCC 47 CFR Part 15 Radio Frequency Devices
● IEC 62133-2: 2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes -
Safety requirements for portable sealed secondary lithium cells, and for batteries made from them,
for use in portable applications - Part 2: Lithium systems
EmbracePlus Symbols used in labeling
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
in 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 Equipment Directive
Indicates the device Serial Number
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