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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(duration of data
recording when
EmbracePlus is not
connected via Bluetooth®
without overwriting data)
Transfer time
(time to transfer data
saved in the EmbracePlus
memory)
5 minutes per hour of recording stored
Data connection
requirement
(amount of data uploaded
from the phone to the
Empatica cloud)
~ 2.4 MB per hour of recording
Data storage requirement
(amount of data used in
the Empatica Cloud, it’s
the amound of data
downloaded when
performing analysis on
sensor raw data)
~ 10 MB per hour of recording
Data Flow and Access
Sensor raw data
Description: Raw data is the high-frequency data collected via the EmbracePlus
sensors.
Flow: Sensor Raw Data is recorded from EmbracePlus' sensors and when available,
transmitted via Bluetooth® using a proprietary protocol to the paired phone. The
phone aggregates circa 15 minutes of raw data and uploads them securely to the
Empatica Cloud. In the Empatica Cloud data is compartmentalized and accessible
according to the Study/Site/Date of acquisition
(i.e. /ORGANIZATION/STUDY/SITE/YEAR/MONTH/DAY/USER/DEVICE/timestamp.avro).
Data type: When accessing Empatica Cloud, the sensor raw data will be
downloadable/accessible/synchronizable as 15-minute Avro files
(https://en.wikipedia.org/wiki/Apache_Avro) identified by a chronological timestamp.
The Avro schema contains the types of data EmbracePlus is collecting (see below for
the complete list).
Data access: The sensor raw data are stored in the Empatica Cloud and can be
accessed either via APIs or via data bucket access. When requesting data via APIs,
Empatica’s Cloud will return one-time secure pre-signed URLs with a list of Avro files
that correspond to the timeframe requested. When accessing directly the bucket
associated with the specific organization (Empatica needs to set up this process in
advance), sensor raw data can be downloaded in any amount (FTP-style download).
Data usage: Avro files can be used through the provided tools
(https://avro.apache.org/docs/current/).