EmbracePlus USER MANUAL UM-22 [Rev 3.0] March 8, 2021 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.
Table of Contents Glossary 4 Product Description 4 Product Description & Manufacturer Information 4 Product Description 4 Manufacturer Information 5 Regulatory and Compliance 6 EmbracePlus product labeling 6 EmbracePlus laboratory testing 7 EmbracePlus Symbols used in labeling 8 Symbols used in labeling 8 Intended use 9 Indication for use statement 9 Intended population and use environment 10 Patients population and Medical Conditions 10 Essential Performance Statement and Safety
Performance Characteristics 15 Technical Specifications 16 Data Collection Specifications 18 Sensors Configuration 18 Data Flow and Access 19 Sensors Raw Data Specifications 20 Storage and Use Conditions 22 Dust and Water Resistance 22 Compatibility with MR and X-ray Scanning 23 EMC Environment 23 Guidance and Manufacturer's declaration - electromagnetic emissions 23 FCC Compliance 23 Guidance and Manufacturer's declaration - electromagnetic immunity 24 Recommended separation dista
Troubleshooting Empatica Support Privacy Protecting your privacy 36 36 36 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, transferr
2. the second character (“material”) indicates the material (e.g. S=Silicone, F= Fabric etc) EmbracePlus shall be charged using the provided On-Wrist Charger (OWC). The OWC works as a common “power bank”: when charged and attached to the EmbracePlus, the charging process starts without any power source.
Regulatory and Compliance EmbracePlus product labeling The information directly printed on the device itself is presented in Figures 1 and 2. Figure 1 - Back view of EmbracePlus On the back of the device the following information is displayed: ● Product Name and Manufacturer name: EmbracePlus by EMPATICA ● Device Serial Number: S/N 123456789 ● IP Classification: Water Resistant (IP67) The information contained in this document is confidential and is the property solely of Empatica, S.r.l..
Figure 2 - Drawing representing the front view of EmbracePlus with band detached On the front of the device the following information is displayed, note that the information is visible after detaching the band: ● Place of manufacturing: Made in Korea ● FCC symbol and FCC ID: FCC-ID xxxxxxxxx ● CE Mark and identification of Notified Body: CE 0051 ● Applied Parts type BF symbol ● Precaution Symbol ● WEEE Symbol EmbracePlus laboratory testing EmbracePlus has been subject to specific laboratory testing to asse
● ● ● ● ● ● IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process EN ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity ISO 10993-10: 2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization FCC 47 CFR Part 15 Radio Frequency Devices IEC 62133-2: 20
IP 67 Indicates that EmbracePlus is classified as IP67 - resistant to submersion in 1 m (about 3.
• Rest Detection. EmbracePlus is intended for temperature monitoring where monitoring temperature at the wrist is clinically indicated. Intended population and use environment EmbracePlus is intended to be used by general population (age 2 and up) that want/need to monitor their physiological parameters at home or in healthcare environments. Physiological Parameters might be reviewed by Caregivers or Healthcare providers.
On-Wrist Charger Essential Performance: The on-wrist charger shall be safe for the user and allow the EmbracePlus to be charged while being worn Service Life EmbracePlus expected service life is 2 years Limitations 1. EmbracePlus is not intended as a primary diagnostic tool 2. EmbracePlus is compatible only with iOS devices and Android devices. 3. Bluetooth connectivity will not work if EmbracePlus is submerged in water, and thus data cannot be transferred to the paired smartphone.
2. Empatica does not recommend wearing the device if you have a known allergy to metals, or you are generally sensitive to skin contact with metals. 3. Keep EmbracePlus clean: bacteria and dirt may cause skin itching or irritation. 4. Do not leave EmbracePlus in environments in which it may overheat beyond the recommended environmental limits (e.g., a car parked under the sun). If EmbracePlus is left exposed to high temperatures, allow it to cool before handling it to avoid possible skin burns. 5.
EmbracePlus Safety - including any hazard that might result from electrical and mechanical failure. Low risk level – no significant harm – EmbracePlus has been designed, developed and manufactured using state of the art techniques, in addition safety tests according to relevant regulatory requirements have been performed. EmbracePlus Electromagnetic Compatibility - including any hazard that might result from internal or external interferences.
Benefits-Risk determination Based on the presented known benefits and the residual severity and probability of the identified risks we determine EmbracePlus residual risks are outweighed by the potential benefits EmbracePlus Materials & Biocompatibility EmbracePlus components EmbracePlus components relevant to the biocompatibility of the device are presented in the table below. This table presents the part name, the quantity per device, the manufacturing material and the manufacturing process.
Technical Specifications and Performance Characteristics Performance Characteristics Physiological Parameters measurement Pulse Rate Range: 30 - 220 bpm Resolution: 0.01 bpm Accuracy: 3 bpm Arms 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.
Technical Specifications EmbracePlus (POD) Case Ingress Protection Classification EmbracePlus Band EmbracePlus Extension EmbracePlus Wrist Charger Band On- EmbracePlus Battery Diameter: 32 mm Thickness: 15 mm Weight: 38 gr (including battery, band and electronics) Color: Black with a matte finish Materials: Case in Polycarbonate, PPG Glass (Gorilla Glass 3) EmbracePlus: IP 67 You can wear EmbracePlus while taking a shower, or in the rain. You can also wear it in pools (not in saltwater).
EmbracePlus Memory E Ink Display Buttons Haptic Feedback PPG Sensor Temperature Sensor Accelerometer Sensor EDA Sensor Compatibility Connectivity Type: NOR Flash Memory Capacity: 128 MB Hours of data stored: Depends on the sensor configuration (see below) Type: Glass-protected E Ink display Display size: 25.
Data Collection Specifications Synchronization Sensor synchronization: All sensors are always synchronized between them. The sensor raw data contains exactly the same amount of data at a nominal frequency for every sensor. Internal synchronization: EmbracePlus internal clock has a maximum accuracy of ± 5 ppm (parts per millions). Thus, as every other electronic system, over a long enough period of time the internal clock might drift.
(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 ~ 2.
Biomarkers Description: Biomarkers are pre-processed data by Empatica’s algorithms that are calculated every minute. Flow: Biomarkers are computed in-app every minute from sensor raw data and securely uploaded to the Empatica Cloud. Data type: Biomarkers files can be used as normal CSV files. Each row is 1 minute for the specific day and each column is a type of biomarker calculated (see below for the complete list).
ElectroDermal Activity Description: Data from the electrodermal activity sensor expressed as microsiemens (µS). Uses a galvanic skin response sensor. Sampling frequency: refer to the HR-optimized configuration above. Values: (array/float) Electrodermal activity (µS). Interbeat Interval Description: List of time intervals between individual heart beats. Values: (array/long + array/int) Timestamps in UTC (µs) of the heartbeat + Interbeat interval (µs).
Storage and Use Conditions Storage Conditions Use Conditions Temperature -25ºC to +70ºC Humidity 20 – 95% Relative Humidity non condensing Pressure 1060 hPa to 500 hPa Battery preservation EmbracePlus can be stored in its original box for a maximum of 3 months without charging. If EmbracePlus is not used for more than 90 days make sure to charge it at least once every 3 months. After use storage EmbracePlus should be properly stored. Do not expose EmbracePlus to direct sunlight, moisture or rain.
Compatibility with MR and X-ray Scanning You must not wear EmbracePlus during either an MRI or an X-ray scan. During an X-ray, the doctor will usually ask you to remove all metal objects since they can affect the quality of the scan. For an MRI, it is especially important to remove all metal objects because the MRI’s magnets will attract them.
Guidance and Manufacturer's declaration - electromagnetic immunity The EmbracePlus is intended for use in the electromagnetic environment specified below. The user of the EmbracePlus should assure that it is used in such an environment. Electrostatic discharge might cause EmbracePlus to reset. Reset will last approximately 20 seconds, after which EmbracePlus will restart recording data.
Frequency Range and Level: RF wireless communication equipment Test Frequency (MHz) Modulation Minimum IMMUNITY Level (V/m) IMMUNITY Level Applied (V/m) 385 Pulse Modulation: 18 Hz 27 27 450 Pulse Modulation: 18 Hz 28 28 710 745 780 Pulse Modulation: 217 Hz 9 9 810 870 930 Pulse Modulation: 18 Hz 28 28 1720 1845 1970 Pulse Modulation: 217 Hz 28 28 2450 Pulse Modulation: 217 Hz 28 28 5240 5500 5785 Pulse Modulation: 217 Hz 9 9 The information contained in this document is conf
Getting started with EmbracePlus How EmbracePlus works EmbracePlus physical device is worn on the user's wrist and continuously collects raw data via its sensors installed on the device body, named POD, or on the device strap.
What EmbracePlus comes with The EmbracePlus package contains: 1 EmbracePlus POD Already connected to EmbracePlus Strap (or Band) 1 EmbracePlus OWC Charging cable Please be careful when unboxing EmbracePlus to avoid possible damages to the device 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.
How to wear EmbracePlus It is important that EmbracePlus is worn correctly to ensure all the device sensors are in contact with the user’s body. Correct contact between sensors and the user's body ensures correct physiological parameters collection and computation. Wear the EmbracePlus with the pod on top of the wrist, so the display faces upwards and the PPG sensors is on the bottom, touching the skin. The EDA electrodes found on the band should line up on the bottom of the wrist.
How to correctly position the OWC on the EmbracePlus EmbracePlus Top View EmbracePlus Side view – OWC Top View charging pins are visible OWC Bottom View – Position the OWC on top of Make sure to position the OWC charging pins are visible the EmbracePlus display. charging pins in line with the EmbracePlus charging pins Connect the OWC charging Completelly lower the OWC By tapping on the OWC top pins to the EmbracePlus on the EmbracePlus.
Setting up EmbracePlus EmbracePlus should be switched on by placing the On-wrist charger on top of the eInk. Using EmbracePlus with compatible Care App EmbracePlus is compatible with Empatica Care App. For using EmbracePlus with the Care App please refer to the specific Care App instruction for use. 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.
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.
EmbracePlus User Interface Guide – Frequently used functions EmbracePlus main interactions, frequently used functions, with users are: - Present local hour EmbracePlus hour is continuously presented and updated every minute, the local time is acquired by the paired smartphone Blinking colon symbol (:) indicates the device is working as expected. - Quick Mark Event Users are able to mark events using the EmbracePlus. Marking events is performed by holding the top button for 5 seconds.
Starting from the main EmbracePlus screen → Click top button → Visualize +1 page → Click top button → Visualize OK? page → Click top button to confirm OR Click bottom button to say NO : ● IF clicked OK → When timestamp has been saved: Visualize tick mark and success vibration – two seconds timeout – Main clock face ● IF clicked NO → Go back to main watch face If, at any point in the flow, there’s no interaction with either button, the usual 10s timeout applies and the screen goes back to the main EmbracePlu
- Connection-Disconnection On the main EmbracePlus screen the empatica logo functions as a sign of active or inactive connection with the paired device. Shaded icon means absence of connection while a well defined icon means EmbracePlus is connected to the paired smartphone. - Memory Full When EmbracePlus memory is 90% full, a warning is visualized.
The screen transitions to night mode, at the same time: ● the half battery icon on bottom row appears ● vibration warning pattern occurs x1 ● screen shows “low” message for 5 seconds ○ total duration of the screen is 5 seconds After the “low” screen, the screen transitions back to the clock face, fixed to night mode. The half battery icon on the bottom row remains fixed until the EmbracePlus is put in charge. When EmbracePlus is put in charge the screen transitions back to day mode.
Troubleshooting Empatica Support For information concerning EmbracePlus and its use, please review our Support Center articles at https://support.empatica.com. We are available to answer your questions at +1 (866) 739-2049. You can also contact us by submitting a request at https://support.empatica.com/hc/enus/requests/new, or sending us an email at support@empatica.com and we'll respond as soon as we can. Privacy Protecting your privacy We take personal data security very seriously.
