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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Figure 2 - Drawing representing the front view of EmbracePlus with band detached
On the front of the device the following information is displayed, note that the information is visible after
detaching the band:
● Place of manufacturing: Made in Korea
● FCC symbol and FCC ID: FCC-ID xxxxxxxxx
● CE Mark and identification of Notified Body: CE 0051
● Applied Parts type BF symbol
● Precaution Symbol
● WEEE Symbol
EmbracePlus laboratory testing
EmbracePlus has been subject to specific laboratory testing to assess its safety, electromagnetic
compatibility, usability and biocompatibility. Tests have been performed according to the
following standards:
● EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012): Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance
● EN 60601-1-2:2015 (IEC 60601-1-2:2014): Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
● IEC 60601-1-6:2010 + Amd1:2013: Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard: Usability
● IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety
and essential performance - Collateral standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment