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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Compatibility with MR and X-ray Scanning
You must not wear EmbracePlus during either an MRI or an X-ray scan.
During an X-ray, the doctor will usually ask you to remove all metal objects since they can affect the
quality of the scan. For an MRI, it is especially important to remove all metal objects because the MRI’s
magnets will attract them.
EMC Environment
Guidance and Manufacturer's declaration - electromagnetic emissions
EmbracePlus is intended for use in the electromagnetic environment specified below. The user of the
EmbracePlus should assure that it is used in such an environment.
Emission Test
Compliance
Electromagnetic environment
RF emission
CISPR 11
Group 1
EmbracePlus uses RF energy only for its internal function.
Therefore its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emission
CISPR 11
Class B
The EmbracePlus device is suitable for use in domestic
establishments and in establishments directly connected to
the low voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic Emission
EN 61000-3-2
Not Applicable
Voltage Fluctuation/
flicker emission
EN 61000-3-3
Not Applicable
FCC Compliance
The FCC id of the EmbracePlus is:
The EmbracePlus device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference that may cause
undesired operation (FCC Title 47, Subpart A, Part 15.19(3)).
Changes or modifications not expressly approved by the party responsible for compliance could void the
user’s authority to operate the equipment (FCC Title 47, Subpart A, Part 15.21)