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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On-Wrist Charger Essential Performance: The on-wrist charger shall be safe for the user and
allow the EmbracePlus to be charged while being worn
Service Life
EmbracePlus expected service life is 2 years
Limitations
1. EmbracePlus is not intended as a primary diagnostic tool
2. EmbracePlus is compatible only with iOS devices and Android devices.
3. Bluetooth connectivity will not work if EmbracePlus is submerged in water, and thus
data cannot be transferred to the paired smartphone.
Warnings and Precautions
Warnings
1. The user must wear the device correctly to ensure correct raw data acquisition and
physiological parameter computation.
2. Do not clean EmbracePlus while wearing it.
3. Do not use EmbracePlus if it appears damaged. Check EmbracePlus for sharp edges and
damage before each use.
4. Users who wear a pacemaker, or who have health conditions which might be sensitive to
small electrical signals should always consult their physicians before wearing any
electronic device, including EmbracePlus.
5. If EmbracePlus is used in a manner not specified by the manufacturer, its performance
characteristics can be altered
6. Adult supervision is required. Due to the presence of small parts used in EmbracePlus, it
is strongly advised that the device only be used on small children under adult supervision.
7. Use the EmbracePlus only with its original accessories provided by Empatica. Other cables
and accessories might affect electromagnetic compatibility performances and device
safety. Using EmbracePlus with accessories, transducers or cables other than those
specified may also result in increased emissions or decreased immunity of Embrace.
8. Do not store EmbracePlus close to other electrical equipment.
9. Portable RF communications equipment, including antennas, can affect EmbracePlus,
thus they can be used no closer than 30 cm (12 inches) to any part of Embrace.
10. Use only 5V (volt) USB power supply certified with IEC 60950-1 to charge EmbracePlus
on-wrist charger.
11. The EmbracePlus on-wrist charger may generate heat when connected to a power source;
be careful when handling it during the charge.
12. Users should never attempt to charge the EmbracePlus on-wrist charger while it is
connected to a worn EmbracePlus.
13. You must not wear EmbracePlus during either an MRI or an X-ray scan.
Precautions
1. Do not place the EmbracePlus watch over broken or damaged skin.