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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Table of Contents
Glossary 4
Product Description 4
Product Description & Manufacturer Information 4
Product Description 4
Manufacturer Information 5
Regulatory and Compliance 6
EmbracePlus product labeling 6
EmbracePlus laboratory testing 7
EmbracePlus Symbols used in labeling 8
Symbols used in labeling 8
Intended use 9
Indication for use statement 9
Intended population and use environment 10
Patients population and Medical Conditions 10
Essential Performance Statement and Safety Information 10
Service Life 11
Limitations 11
Warnings and Precautions 11
Warnings 11
Precautions 11
Risks and Benefits 12
Risks 12
Benefits 13
EmbracePlus Materials & Biocompatibility 14
EmbracePlus components 14
Biocompatibility information 14
Technical Specifications and Performance Characteristics 15