Download
Share
Print this page
Empatica EmbracePlus User Manual
  1. Manuals
  2. Brands
  3. Empatica Manuals
  4. Personal Care Products
  5. EmbracePlus
  6. User manual

Empatica EmbracePlus User Manual

Hide thumbs Also See for EmbracePlus:

Advertisement

Quick Links

Download this manual
EmbracePlus
USER MAN UAL
0051
UM-22 | Rev 4.0, November 2021

Advertisement

loading
Need help?

Need help?

Do you have a question about the EmbracePlus and is the answer not in the manual?

Questions and answers

Related Manuals for Empatica EmbracePlus

Summary of Contents for Empatica EmbracePlus

  • Page 1 EmbracePlus USER MAN UAL 0051 UM-22 | Rev 4.0, November 2021...

  • Page 2: Table Of Contents

    Table of contents 01 Embraceplus At A Glance 02 Using Embraceplus For The First Time 03 Using Embraceplus In Daily Life 04 Troubleshooting 05 FAQs 06 Regulatory And Compliance 07 Document History Index...

  • Page 3: Embraceplus At A Glance

    EmbracePlus at a glance...
  • Page 4 What the EmbracePlus does EmbracePlus is a wearable device that collects, processes, stores, and wirelessly transmits physiological parameters to a companion app/system. EmbracePlus runs different on-board algorithms to conGnuously analyze acquired data and extract specific digital biomarkers. 1. Serial number 2.
  • Page 5 How it works This is how EmbracePlus works: The EmbracePlus (1), the wearable, collects physiological parameters from your wrist. The data are then transferred to a companion app/system (2) via Bluetooth. Data access (3) is then provided via the companion app/system for the intended use.
  • Page 6 Types of data that EmbracePlus collects EmbracePlus seamlessly collects the following* physiological parameters from your wrist: pulse rate, pulse rate variability, respiratory rate, blood oxygen saturaGon, electrodermal acGvity, skin temperature, acGvity counts, and sleep. *Depending on sensor configuraGon 01. EmbracePlus at a glance...

  • Page 7: Using Embraceplus For The First Time

    Using EmbracePlus for the first time...
  • Page 8 Getting started Using EmbracePlus is simple. Follow these steps to get started: STEP 1: UNBOX EMBRACEPLUS a. Pull the tab and slide the sleeve from the package to extract the box. b. Gently pull out the EmbracePlus. 02. Using EmbracePlus for the first time...
  • Page 9 Components of the box: I. EmbracePlus II. Cable charger III. Folder with the Quick Reference Guide 02. Using EmbracePlus for the first time...
  • Page 10 Turn on EmbracePlus by pressing the upper buXon, as indicated by the small hand on the sGcker. b. EmbracePlus will greet you with a HI. If nothing happens, you may need to charge it. Remove the sGcker and proceed.
  • Page 11 IMPORTANT If EmbracePlus doesn’t turn on In the unlikely event in which your EmbracePlus is out of baXery, the device will not react when pressing the buXon. To turn it on, you will first need to charge EmbracePlus with the cable charger included in the box.
  • Page 12 STEP 3: WEAR EMBRACEPLUS AND START RECORDING PHYSIOLOGICAL PARAMETERS  Wearing EmbracePlus correctly is crucial for enabling proper recording of physiological parameters. The EmbracePlus needs to be correctly in place with the sensors touching the skin in order for it to collect data properly.
  • Page 13 Push the pins into the holes. Be aware that a loose band might impair data collecGon. d. Secure using the loop Slide the tail of the band through the loop to secure it in posiGon. 02. Using EmbracePlus for the first time...
  • Page 14 IMPORTANT Make sure the EmbracePlus fits snugly but not too Gghtly. Only wear the EmbracePlus on intact skin. Do not use the EmbracePlus with injured skin or other types of skin diseases located in the area where you plan to wear the EmbracePlus.

  • Page 15: Using Embraceplus In Daily Life

    Using EmbracePlus in daily life...
  • Page 16 Display and interaction guide The EmbracePlus display uses E Ink technology, which consumes liXle energy and always remains on, even if the EmbracePlus is out of baXery. When EmbracePlus is recording data and connected to the companion app/system, you will find the following components on the display: 1.
  • Page 17 PM. The hour is shown in the outer circle, while the minutes are shown in the center of the display. The Gme indicated by EmbracePlus is based on the Gme of the paired companion app/ system. 03. Using EmbracePlus in daily life...
  • Page 18 HOW TO CHECK IF EMBRACEPLUS IS RECORDING DATA When EmbracePlus is recording data, the display background is light. When EmbracePlus is not recording data, the display background will turn dark. This behavior is to be expected in the following cases: •...
  • Page 19 HOW TO CHECK IF EMBRACEPLUS IS CONNECTED TO THE COMPANION APP/SYSTEM The EmpaGca heart will be visible if EmbracePlus is connected to the companion app/system via Bluetooth, and not visible if it is disconnected. Although EmbracePlus can work stand-alone for several hours, the more it stays connected to the companion app/ system, the beXer.
  • Page 20 How to check and charge the battery In order for it to conGnuously collect your data, EmbracePlus needs to be kept charged according to the instrucGons of the administrator. You can always check the status of your baXery directly on EmbracePlus.
  • Page 21 When the EmbracePlus baXery level is criGcal, a “low” message will appear on the display. The message can be dismissed by placing the EmbracePlus on the charger or pressing one of the side buXons. 03. Using EmbracePlus in daily life...
  • Page 22 OUT OF BATTERY - PLACE IN CABLE CHARGER When completely out of baXery, the EmbracePlus will turn off. The background of the display will turn dark to highlight that data recording has stopped and an empty baXery icon will be displayed.
  • Page 23 4. When EmbracePlus is fully charged, gently remove it by holding the cable charger in place and sliding out the EmbracePlus. 5. For about 10 seconds, the EmbracePlus display will have a dark background. Once the display background turns light and the Gme is shown, EmbracePlus is up and running and ready to be used.
  • Page 24 HOW TO TAG AN EVENT The EmbracePlus allows the user to tag events according to the administrator’s instrucGons. To tag an event, press one of the side buXons for one second and a checkmark will appear on the display confirming the acGon. The display will then go back to show the Gme.
  • Page 25 2. Take a polyester/cellulose wipe. 3. Soak the wipe in 70% isopropyl alcohol for 5 minutes. 4. Thoroughly clean the EmbracePlus for at least 1 minute by wiping the whole device. 5. Visually check the whole device for traces of dirt. In case you see visible contaminaGon, repeat the cleaning procedure.
  • Page 26 Gmely data collecGon. Wear the EmbracePlus preferably on your non-dominant wrist, or according to the instrucGons of the administrator. It is important to always have EmbracePlus charged. When the EmbracePlus baXery runs low, the baXery icon will appear on the display.

  • Page 27: Troubleshooting

    Troubleshooting...
  • Page 28 NOT RECORDING - MEMORY FULL When the display background is dark and an ‘M’ appears, the EmbracePlus memory is full of already recorded data, and it has stopped recording new data. A full memory occurs when the EmbracePlus is disconnected from the companion app/system for several hours and is unable to synchronize data.
  • Page 29 CALIBRATING When the EmbracePlus is calibraGng, you will see 4 dots moving on a dark background. This happens right a`er the EmbracePlus is removed from the charger. The watch face will be visible a`er a few seconds. Keep wearing your EmbracePlus.
  • Page 30 SUDDEN REBOOT In case EmbracePlus self-reboots, you will see a dark display with ‘HI!’ for a few seconds. EmbracePlus self-reboots to restore proper funcGoning in cases of unexpected behavior. During this brief interval, data recording will stop. Once recording resumes, the display background will turn light again and the Gme will be shown.
  • Page 31 MANUAL REBOOT In case there is a firmware error detected by the EmbracePlus, an exclamaGon point (!) symbol will appear on the display, indicaGng that a manual reboot is required. a. The firmware error may happen while the EmbracePlus is recording data, shown by the light display background.
  • Page 32 Make sure that the environmental condiGons are within the operaGonal range (0 - 50°C) of the EmbracePlus. Then, press the OK (upper) buXon and the EmbracePlus will reboot and wake up from hibernaGon, indicated by the ‘HI’ message.

  • Page 33: Faqs

    FAQs...
  • Page 34 • Press one of the side buXons on the EmbracePlus to verify the baXery levels. • If the EmpaGca heart icon is visible, the EmbracePlus is synchronizing data via Bluetooth to the companion app/ system.
  • Page 35 4. HOW CAN I TURN THE EMBRACEPLUS ON/OFF? Once you unbox EmbracePlus and turn it on, it will remain ON unGl it runs out of baXery. In case it runs out of baXery (you will see a baXery icon on a dark background), please place it back in the cable charger and it will automaGcally switch ON.
  • Page 36 The display background of the EmbracePlus turns dark when data recording stops. This happens when you take off your EmbracePlus and put it on the cable charger, or if the EmbracePlus baXery has drained. 9. HOW CAN I CHECK THE BATTERY LEVEL OF THE EMBRACEPLUS? The baXery level of the EmbracePlus can be verified by pressing...
  • Page 37 12. WHAT SHOULD I DO IF MY SKIN IS RED, ITCHY, OR I FEEL PAIN? Stop wearing EmbracePlus if the skin on your wrist becomes red, itchy, or if any pain is felt. If this happens, please contact the administrator with photos of the affected area.

  • Page 38: Regulatory And Compliance

    Regulatory and Compliance...
  • Page 39 Figures 1 and 2. Figure 1 - Back view of EmbracePlus On the back of the device, the following informaGon is displayed: • Product Name and Manufacturer name: EmbracePlus by EMPATICA • Device Serial Number: S/N 123456789 • IP ClassificaGon: Water Resistant (IP67)
  • Page 40 Figure 2 - Drawing represenGng the front view of EmbracePlus with band detached On the front of the device the following informaGon is displayed, note that the informaGon is visible a`er detaching the band: • Place of manufacturing: Made in Korea •...
  • Page 41 EmbracePlus laboratory testing EmbracePlus has been subject to specific laboratory tesGng to assess its safety, electromagneGc compaGbility, usability and biocompaGbility. Tests have been performed according to the following standards: • EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012): Medical electrical equipment – Part 1: General requirements for basic safety and essenGal performance •...
  • Page 42 • ISO 10993-10: 2010 Biological evaluaGon of medical devices — Part 10: Tests for irritaGon and skin sensiGzaGon • FCC 47 CFR Part 15 Radio Frequency Devices • IEC 62133-2: 2017 Secondary cells and baXeries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for baXeries made from them, for use in portable applicaGons - Part 2: Lithium systems...
  • Page 43 CE CerGficaGon Process Indicates EmpaGca S.r.l as the legal manufacturer of EmbracePlus Indicates that the electromagneGc interference from the EmbracePlus is under the limits that are approved by the Federal CommunicaGons Commission The EmbracePlus uses Bluetooth Low Energy to transfer data.
  • Page 44 Indicates the manufacturing date of the device Indicates that EmbracePlus is classified as IP67 - resistant to submersion in 1 m (about 3.3 feet) of water for up to 30 minutes Keep in dry condiGons and away from rain Indicates the device Lot Number...
  • Page 45 Intended use EmbracePlus is intended to collect, process with embedded AI/ML algorithms, store, transfer and remote monitoring of the following* physiological parameters: Pulse Rate (PR), Pulse Rate Variability (PRV), Respiratory Rate (RR), Blood oxygen saturaGon (SpO2), Temperature (TEMP), Electrodermal AcGvity (EDA), AcGvity Counts, and Sleep DetecGon.
  • Page 46 EmbracePlus is intended for conGnuous paGent monitoring of paGents* in professional healthcare faciliGes, such as hospitals or skilled nursing faciliGes, or in their own home. EmbracePlus collected data are intended to be used for paGent monitoring by trained healthcare professionals only.
  • Page 47 Intended population and use environment EmbracePlus is intended to be used by the general populaGon (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, Healthcare providers, or Researchers.
  • Page 48 • NaGonality: not relevant • PaGent status: the paGent is o`en the same as the operator and should be willing and capable of managing its use CAREGIVER POPULATION - EMBRACEPLUS • Healthcare professionals • OccupaGonal doctors • Nurses 06. Regulatory and Compliance...
  • Page 49 Statement and Safety Information EMBRACEPLUS ESSENTIAL PERFORMANCE EmbracePlus shall be able to conGnuously collect, via specific sensors, the user’s physiological parameters and transfer them to the paired companion app/system without being corrupted or lost. The maximum allowed quanGty of data not being collected or lost during the normal use of the device is 5% of the duraGon of an acquisiGon session.
  • Page 50 Service Life EmbracePlus expected service life is 2 years. 06. Regulatory and Compliance...
  • Page 51 Limitations 1. EmbracePlus is not intended as a primary diagnosGc tool. 2. EmbracePlus is compaGble only with iOS devices and Android devices that support Bluetooth 5.0. 3. Bluetooth connecGvity will not work if EmbracePlus is submerged in water, and thus data cannot be transferred to the companion app/system.
  • Page 52 EmbracePlus. 5. If EmbracePlus is used in a manner not specified by the manufacturer, their protecGon, funcGonaliGes, and performance they provide could be compromised.
  • Page 53 10. The EmbracePlus cable charger may generate heat when connected to a power source; be careful when handling it during the charge. 11. You must not wear EmbracePlus during either an MRI or an X- ray scan. 12. For the funcGoning of the system, the following condiGons shall be met: a.
  • Page 54 5. Changes or modificaGons not expressly approved by the manufacturer could void the user’s authority to operate the equipment. 6. Avoid using EmbracePlus in a hot tub, sauna, or steam rooms. 06. Regulatory and Compliance...
  • Page 55 Risks The list below represents all aspects that should be considered as cauGons resulGng from the Risk Management Process of the EmbracePlus. The user is required to carefully read this manual before using the device. PHYSIOLOGICAL PARAMETERS PRESENCE AND QUALITY...
  • Page 56 EMBRACEPLUS ELECTROMAGNETIC COMPATIBILITY Including any hazard that might result from internal or external interferences. Low risk level – no significant harm – EmbracePlus has been designed, developed, and manufactured using state of the art techniques. In addiGon, electromagneGc compaGbility tests have been performed according to relevant regulatory requirements.
  • Page 57 EMBRACEPLUS USABILITY Including any hazard that might result from the user errors or design failure. Low risk level – no significant harm – EmbracePlus user interface and user experience have been designed and tested following relevant regulatory requirements. Moreover, EmbracePlus labeling documents contain all the relevant informaGon for a flawless use of the device.
  • Page 58 EmbracePlus Materials & Biocompatibility EMBRACEPLUS COMPONENTS EmbracePlus components relevant to the biocompaGbility of the device are presented in the table below. This table presents the part name, the quanGty per device, the manufacturing material, and the manufacturing process. Part Name...
  • Page 59 It is therefore unlikely that users will develop an allergic reacGon from EmbracePlus. However, some people may noGce a slight reacGon on their skin. If this happens, please contact the enGty that provided EmbracePlus to you with a picture of the affected area(s).
  • Page 60 EmbracePlus Technical Specifications and Performance Characteristics PERFORMANCE CHARACTERISTICS Physiological Pulse Rate Range: 24 - 240 bpm Parameters ResoluGon: 1 bpm measurement Accuracy (no moGon): 3 bpm Arms Accuracy (moGon): 5 bpm Arms PRV - RMSSD Typical range: 0 - 300 ms ResoluGon: 0.01 ms...
  • Page 61 Rest DetecGon Range: 0 - 400 (0-99: wake epoch; Physiological 100-299: rest epoch; 300-399: rest Parameters interruption epoch; 400: for future measurement 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...
  • Page 62 30 minutes. Avoid using EmbracePlus in a hot tub, sauna, or steam rooms. Please note that the Bluetooth connecGvity will not work if EmbracePlus is submerged in water, and thus data cannot be transferred to the companion app/system. Recorded...
  • Page 63 Type: 3.8V Li-ion EmbracePlus Capacity: 155 mAh BaXery BaXery life: 2 years or up to 500 cycles Charging Gme (0% to 100%): 90 minutes (worst case) BaXery duraGon (100% to 0%): 1 to 2 days (depends on the sensor configuraGon)
  • Page 64 Type: Custom-built by EmpaGca (mulG-channel, Photoplethy- mulG-wavelengths) smography Channels: 4 acquisiGon channels (via 8 (PPG) Sensor photodiodes) Wavelengths: Red, Infra-Red, Green via 9 LEDs Sampling Rate: 26 Hz – 208 Hz Type: Digital temperature sensor (Texas Temperature Instruments TMP117M) Sensor Range: 0 - 50°C ResoluGon: 0.01ºC Accuracy: ±...
  • Page 65 ConnecGvity Main standard: Bluetooth® 5 Fallback standard: Bluetooth® Low Energy 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 EncrypGon Standard) 06.
  • Page 66 NOTE: A`er storage at the extreme temperature indicated in the table above allow the device to return to room temperature (15ºC – 30Cº) before wearing EmbracePlus by leaving it at room temperature for at least 30 minutes. 06. Regulatory and Compliance...
  • Page 67 DUST AND WATER RESISTANCE EmbracePlus You can wear EmbracePlus while taking a shower, or in the rain. You can also wear it in pools (not in saltwater). You should not submerge EmbracePlus in water that is deeper than 3.3. feet or 1 meter or for more than 30 minutes.
  • Page 68 EMC Environment GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC EMISSIONS EmbracePlus is intended for use in the electromagneGc environment specified below. The user of the EmbracePlus should assure that it is used in such an environment. Emission Test Compliance Electromagne?c environment...
  • Page 69 FCC COMPLIANCE The EmbracePlus device complies with part 15 of the FCC Rules. OperaGon is subject to the following two condiGons: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operaGon (FCC Title 47, Subpart A, Part 15.19(3)).
  • Page 70 RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND EMBRACEPLUS EmbracePlus is intended for use in an electromagneGc environment in which radiated RF disturbances are controlled. The user of the EmbracePlus can help prevent electromagneGc interference by maintaining a minimum distance between portable...
  • Page 71 MANUFACTURER INFORMATION EmbracePlus is manufactured by Name: EmpaGca S.r.L. Address: Via Enrico Stendhal, 36 City: Milan Zip: 20144 Phone: +39 02 36566473 Website: www.empaGca.com Made in Republic of Korea 06. Regulatory and Compliance...
  • Page 72 ELECTRONIC LABELING INFORMATION A PDF copy of this InstrucGon for Use is available at: hXp:/ /empaGca.com/manuals/embraceplus In case you want a paper copy of this InstrucGon for Use, you can request it from the administrator. The paper copy will be provided to you within 7 calendar days and free of charge.

  • Page 73: Document History

    Document history...
  • Page 74 Revision Date Descrip?on Rev 1.0 April 1, IniGal release of the document 2021 Rev 2.0 April 16, Update 2021 Rev 3.0 March 8, Update 2021 Rev 4.0 November 03, Update 2021 07. Document history...