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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Maintenance & Cleaning of EmbracePlus
EmbracePlus does not need particular inspections, maintenance or calibration to reach its
intended performances. Good general care shall be taken when using the device to avoid
involuntary damages such as falling or crash damages.
Cleaning of the EmbracePlus
EmbracePlus is designed to be suitable for repeated use by multiple users. The customer must
ensure that the device is properly disinfected before being transferred between individual users
to prevent the transmission of skin diseases.
EmbracePlus and all its accessories were cleaned before shipment but must be considered as
non-sterile. Before switching between users and at least weekly, it is recommended to clean the
device. The disinfection process should include one or more of the following methods:
- Exposure to UVC lamp with a wavelength between 200 – 280 nm,
- Cleaning the EmbracePlus by wiping it with isopropyl alcohol (concentration ≥70%),
Remember to power off the device before cleaning. Make sure any residual cleaning solution has
dried prior to powering on the EmbracePlus after cleansing.
Do not use cleaning agents other than those described above without explicit written instructions
from Empatica.