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.
15
Technical Specifications and Performance Characteristics
Performance Characteristics
Physiological
Parameters
measurement
Pulse Rate
Range: 30 - 220 bpm
Resolution: 0.01 bpm
Accuracy: 3 bpm A
rms
PRV - RMSSD
Typical range: 0 - 300 ms
Resolution: 0.01 ms
Accuracy: 98% of positive agreement, with respect to the
ECG. Absolute relative error < 10%. The comparison was
made on recordings of healthy subjects in still conditions.
Respiration Rate
Range: 4 - 60 rpm
Resolution: 1 rpm
Accuracy: 3 rpm A
rms
Temperature
Range: 0ºC - +50ºC
Resolution: 0.1ºC
Accuracy: ± 0.1ºC within 30.0ºC - 45.0ºC range
ElectroDermal Activity
Range: 0.01 μSiemens – 100 μSiemens.
Resolution: 1 digit ~ 900 pSiemens.
Rest Detection
Range: 0 - 400 (0-99: wake epoch; 100-299: rest epoch;
300-399: rest interruption epoch; 400: for future use)
Accuracy: The Rest detection algorithm did not miss any of
the 46 PSG-derived sleep periods (Sensitivity = 100%). On
average, the Rest detection algorithm detected an earlier
sleep onset and a later sleep offset, with an overall longer
sleep period duration compared to PSG.
SpO
2
Range: 70% - 100%
Resolution: 1 %
Accuracy: 2% A
rms
A
RMS
accuracy is a statistical calculation of the difference between device measurements and reference
measurements. Approximately two-thirds of the device measurements fall within +/- A
RMS
of the reference
measurement.










