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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Guidance and Manufacturer's declaration - electromagnetic immunity
The 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.
Electrostatic discharge might cause EmbracePlus to reset. Reset will last approximately 20 seconds, after
which EmbracePlus will restart recording data. Based on the performed risk analysis missing 20 seconds
of data has been identified as an acceptable risk, since it does not have impact on the user safety.
Immunity Test
IEC 60601-1-2
test level
Compliance
Level
Electromagnetic environment- guidance
Electrostatic
Discharge (ESD)
EN 61000-4-2
8 kV contact
2/4/8/15 kV Air
IEC 60601-1-2
Test level
Floors should be wood. concrete or ceramic
tile. If floors are covered with synthetic
material. the relative humidity should be at
least 30%.
Radiated
electromagnetic
field
IEC 61000-4-3
10 V/m
80 MHz to 2.7
GHz
IEC 60601-1-2
Test level
Portable and mobile RF communications
equipment should be used no closer to any
part of EmbracePlus, including cables than
the recommended minimum separation
distance of 30 cm.
Power Frequency
(50/60 Hz)
Magnetic Field
EN 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
Interference may occur in the vicinity of equipment marked with the following symbol:
Recommended separation distance between portable and mobile RF communications equipment and
EmbracePlus
EmbracePlus is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The user of the EmbracePlus can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communication equipment (transmitter) and the
EmbracePlus as recommended below, according to the maximum output power of the communication
equipment.