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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EmbracePlus Memory
Type: NOR Flash Memory
Capacity: 128 MB
Hours of data stored: Depends on the sensor configuration (see below)
E Ink Display
Type: Glass-protected E Ink display
Display size: 25.9 mm
Glass: Corning® Gorilla® Glass 3
Glass features: High resistance to scratch and sharp contact damage; high retained
strength after use; superior surface quality
E Ink specifications: Black & White, always-on, no backlight, 62 segments, 2Hz max
refresh rate
Display features: always-on clock face (time-synchronized with phone), battery
level (in percentage), Bluetooth® connection/disconnection indication, error
states, menu navigation.
Buttons
Type: two mechanical buttons
Actions: menu navigation, confirmation, event tagging
Haptic Feedback
Type: Multi-pattern Linear Resonant Actuator (LRA) vibration motor
PPG Sensor
Channels: 4 acquisition channels (via 8 photodiodes)
Wavelengths: Red, Infra-Red, Green
Sampling Rate: 26 Hz – 208 Hz
Temperature Sensor
Range: 0 - 85°
Resolution: 0.01ºC
Accuracy: ± 0.1ºC within 30.0ºC - 45.0ºC range (medical application calibration)
Sampling Rate: 1 Hz - 4 Hz
Accelerometer
Sensor
Type: High precision 3D microelectromechanical accelerometer and gyroscope
Range: from ±2 to ±16g, ±2000 dps
Resolution: 16bit (0.488mg/LSB, 70mdps/LSB)
Accuracy Accelerometer: ±0.01%/°C, 110μg/√Hz
Accuracy Gyroscope: ±1% on sensitivity, ±0.007%/°C, 3.8mdps/√Hz
Sampling Rate: 26 Hz – 208 Hz
EDA Sensor
Range: 0.01 μSiemens – 100 μSiemens
Resolution: 1 digit ~ 55 pSiemens
Sampling Rate: 1 - 4 Hz
Compatibility
iOS operative system: iOS 11 or higher
Empatica support iPhone 8 and higher.
Android 5.0 or higher
Bluetooth® 5.0 is supported from Android 8.0 (Oreo) or higher (might depend on
the specific manufacturer).
Connectivity
Main standard: Bluetooth® 5
Fallback standard: Bluetooth® Low Energy 4.2
Range: Maximum 10 meters / 30 feet (in line of sight)
Radio Frequency: 2.4 - 2.5 GHz
Maximum speed: Up to 2Mbits on supported Phones
Security: AES 128 Bit (Advanced Encryption Standard)