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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Troubleshooting 36
Empatica Support 36
Privacy 36
Protecting your privacy 36
How we use your data 36
How you can manage your data 36
Additional protection for minors 36
Glossary
AI/ML: Artificial Intelligence/Machine Learning
UI: User Interface
UX: User Experience
POD: Main EmbracePlus Body
OWC: On-Wrist charger
Product Description
Product Description & Manufacturer Information
Product Description
EmbracePlus is a medical device intended to be used for the collection, processing, storing,
transferring, and remote monitoring of physiological parameters.
EmbracePlus is a wearable biosensor device that collects, processes via embedded AI/ML
algorithms, stores, and wirelessly transmits physiological parameters via Bluetooth to a paired
smartphone. EmbracePlus runs different on-board algorithms to continuously process sensors’
acquired raw data to extract specific physiological parameters including Pulse Rate, Pulse Rate
Variability, temperature, Respiration rate, SpO2, Electrodermal activity and Physical activity. The
computed physiological parameters can be presented to the user via the device UI and
transmitted to the paired smartphone for data transferring to a remote monitoring platform.
EmbracePlus comes in different variants, each with the same intended use and operative
principles, but with different band colors and materials. The specific catalog number is provided
on the device box label and follows this logic:
EMBP- {color} - {size, material} where:
● {color} - is a 2 character variable indicating the color (i.e. CW=Cortina White)
● {size, material} - is a 2 character variable where:
1. the first character (“size”) indicates the size (e.g S=Small, M=Medium)