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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Frequency Range and Level: RF wireless communication equipment
Test Frequency
(MHz)
Modulation
Minimum
IMMUNITY Level
(V/m)
IMMUNITY Level Applied
(V/m)
385
Pulse Modulation: 18 Hz
27
27
450
Pulse Modulation: 18 Hz
28
28
710
745
780
Pulse Modulation: 217 Hz
9
9
810
870
930
Pulse Modulation: 18 Hz
28
28
1720
1845
1970
Pulse Modulation: 217 Hz
28
28
2450
Pulse Modulation: 217 Hz
28
28
5240
5500
5785
Pulse Modulation: 217 Hz
9
9