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Empatica EmbracePlus Instructions For Use Manual Download Page 127

EMC ENVIRONMENT

Guidance and Manufacturer's declaration - electromagnetic emissions

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.

Emission Test

Compliance

Electromagnetic environment

RF emission

CISPR 11

Group 1

EmbracePlus uses RF energy only for

its internal function. Therefore, its
RF emissions are very low and are

not likely to cause any interference in
nearby electronic equipment.

RF emission

CISPR 11

Class B

The EmbracePlus device is suitable

for use in domestic establishments
and

in

establishments

directly

connected to the low voltage power
supply

network

that

supplies

buildings

used

for

domestic

purposes.

Harmonic

Emission
EN 61000-3-2

Not

Applicable

Voltage

Fluctuation/
flicker

emission
EN 61000-3-3

Not

Applicable

FCC COMPLIANCE

The EmbracePlus device complies with part 15 of the FCC Rules.

Operation is subject to the following two conditions:

126

Summary of Contents for EmbracePlus

Page 1: ...Patient Instructions for use Empatica Health Monitoring Platform Patient instructions for use English UM 74 Rev 2 0 June 2022 ...

Page 2: ...statement Documentation features Safety considerations EmbracePlus disposal Cybersecurity EmbracePlus user manual Care App user manual Empatica support center Technical specifications Performance characteristics Safety Precautions Regulations Compliance 1 ...

Page 3: ...o be used by trained administrators to remotely monitor physiological parameters in ambulatory users in home healthcare and professional healthcare environments Hardware component The Empatica Health Monitoring Platform consists of the following hardware components EmbracePlus wearable medical device Class II Type BF Applied Part Cable charger 2 ...

Page 4: ...her Android smartphones running Android 5 or higher Note that the Care App is identical on both iOS and Android As such the processes explained below are the same across both platforms CARE PORTAL Available on Chrome version 86 0 4240 or higher Firefox version 81 0 or higher Safari version 14 0 or higher Edge version 85 0 564 3 ...

Page 5: ...th Monitoring Platform is intended to be used in ambulatory users in healthcare facilities and home settings The Empatica Health Monitoring Platform is intended for the retrospective review of the collected physiological parameters The Empatica Health Monitoring Platform is not intended to be used by acutely ill cardiac patients with the potential to develop life threatening arrhythmias or to be u...

Page 6: ...ironments The device supports continuous monitoring of Pulse Rate Oxygen Saturation Peripheral Skin Temperature and Electrodermal activity as well as intermittent monitoring of Respiratory Rate and Pulse Rate Variability during periods without any motion Activity sensors are used to detect sleep periods and monitor the activity associated with movement during sleep The Empatica Health Monitoring P...

Page 7: ...mpatica Health Monitoring Platform is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias The Empatica Health Monitoring Platform is not a substitute for an ECG monitor and is not intended for diagnostic purposes or to be used as the sole basis for clinical decision making The Empatica Health Monitoring Platform is not intended for oxygen...

Page 8: ...ovascular diseases The Empatica Health Monitoring Platform does not include and is not intended for automated arrhythmia analysis The Empatica Health Monitoring Platform provides PRV as the root mean square of successive differences RMSSDs between consecutive systolic peaks detected on the PPG signal in milliseconds Depending on sensor configuration 7 ...

Page 9: ...ol Description Symbol Description Indicates compliance with the European Medical Device Directive 93 42 EEC 0051 is the identification number of the Notified Body responsible for the CE Certification Process Indicates Empatica S r l as the legal manufacturer of EmbracePlus Indicates that the electromagnetic interference from the EmbracePlus is under the limits that are approved by the Federal Comm...

Page 10: ...device Indicates the manufacturing date of the device IP 67 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 conditions and away from rain Indicates the device Lot Number Indicates the minimum and maximum temperature at which the EmbracePlus shall be stored Indicates the minimum and maximum pressure at which th...

Page 11: ...ration BLE Bluetooth Low Energy Administrator s Throughout this document the term administrator s is used to identify healthcare professional and researchers using the product User s Throughout this document the term user s is used to identify patient s and clinical trial participant s using the product and whose physiological parameters are being monitored Companion app system Throughout this doc...

Page 12: ...d in these Instructions for Use and on product labels WARNING No modification of the product is allowed Modification of this product may cause interference with other devices injury to patient and user including electric shock burns or death WARNING Do not operate the product in areas such as magnetic resonance imaging MRI environments while taking an X Ray or in hyperbaric chambers Do not operate...

Page 13: ...Plus is used in a manner not specified by the manufacturer the protection functionalities and performance they provide could be compromised WARNING EmbracePlus and any other applied parts should be removed prior to patient defibrillation CAUTION Read all cleaning instructions carefully before cleaning EmbracePlus Refer to the cleaning and disinfecting chapter of the instructions for use 12 ...

Page 14: ...ce it in a trash compactor Do not puncture the battery When disposing of EmbracePlus please return it to Empatica and observe all applicable laws and regulations Its return to Empatica will be arranged via Empatica Support This medical device is subject to the EU Directive 2012 19 EU WEEE It may not be disposed of at municipal collection points for waste electrical and electronic equipment 13 ...

Page 15: ...App are encrypted using the 128 bit AES CCM encryption standard Empatica s Care App can be installed on an iOS device running iOS version 11 or higher or an Android device running Android version 8 Oreo or higher As Apple reviews every application before it is allowed on the Apple App Store the iPhone is very resilient to cyberattacks The Google Play store reviews applications for the Android plat...

Page 16: ...of missing cellular data or Wifi connection or in the rare event of the unavailability of Empatica s servers you should continue to wear EmbracePlus and use the Care App as your physiological parameters will continue to be collected You shall promptly solve the underlying issue causing the absence of cellular data or WiFi connection Once cellular data or the WiFi connection is restored the collect...

Page 17: ... Care App will notify the user through a specific on screen notification Clicking the notification will access the Apple App Store in the case of iOS or the Google Play Store in the case of Android where the up to date version can be downloaded EmbracePlus firmware should be updated as soon as a new version becomes available When a new version becomes available the Care App will automatically upda...

Page 18: ...e with the Care App installed also has a device passcode set You should never disclose your Care App username or password You should never write down your Care App username or password You should never provide access to the Care App to an unauthorized user You should never leave the mobile phone with the Care App installed logged in and unattended You should never connect the mobile device where t...

Page 19: ...EmbracePlus EmbracePlus User Manual English 18 ...

Page 20: ...Index EmbracePlus 1 EmbracePlus at a glance 22 2 Using EmbracePlus for the first time 27 3 Using EmbracePlus in daily life 35 4 Troubleshooting 50 5 FAQs 56 19 ...

Page 21: ...ctromagnetic compatibility performances and device safety Using EmbracePlus with accessories transducers or cables other than those specified may also result in increased emissions or decreased immunity of Embrace CAUTION Do not wear the EmbracePlus on broken or damaged skin CAUTION Empatica does not recommend using the device with patients clinical trial participants with a known allergy to metal...

Page 22: ...heir physicians before wearing any electronic device including EmbracePlus It is expected that the user is able to set up EmbracePlus and the companion app system themselves They should also be able to charge EmbracePlus themselves and will be provided with a Quick Reference Guide and user instructions to help them accomplish these tasks 21 ...

Page 23: ...smits physiological parameters to a companion app system EmbracePlus runs different on board algorithms to continuously analyze acquired data and extract specific digital biomarkers 1 Serial number 2 E Ink display 3 Pod Case sensors Accelerometer Gyroscope Photoplethysmogram PPG Temperature 4 Band sensors Electrodermal Activity EDA 22 ...

Page 24: ...Plus 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 23 ...

Page 25: ... seamlessly collects the following physiological parameters from your wrist pulse rate pulse rate variability respiratory rate blood oxygen saturation electrodermal activity skin temperature activity counts and sleep Depending on sensor configuration 24 ...

Page 26: ... 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 Components of the box i EmbracePlus ii Cable charger iii Folder with the Quick Reference Guide 25 ...

Page 27: ...CEPLUS a Turn on EmbracePlus by pressing the upper button as indicated by the small hand on the sticker b EmbracePlus will greet you with a HI If nothing happens you may need to charge it Remove the sticker and proceed 26 ...

Page 28: ...ir EmbracePlus to the companion app system by following the provided instructions If no pairing happens within a few minutes EmbracePlus will automatically switch off to preserve battery Return to step 1 27 ...

Page 29: ...s watchface Press OK to accept the connection request or NO to reject it Accept pairing requests only if you know from which device the request is coming e You are all set to use EmbracePlus The administrator will give you further instructions on how the EmbracePlus should be used in your daily life 28 ...

Page 30: ...us is out of battery the device will not react when pressing the button To turn it on you will first need to charge EmbracePlus with the cable charger included in the box Please follow the charging instructions in the How to charge EmbracePlus section 29 ...

Page 31: ... computation CAUTION For the functioning of the system the following conditions shall be met a The user must wear the EmbracePlus properly and have it remain within close proximity 30 feet or 10 meters to the paired companion app system b The paired companion app system must be connected to the internet c The EmbracePlus does not show warning messages d The EmbracePlus and the companion app system...

Page 32: ...ce one 1 finger s width from your wrist bone 3 Fasten the band and secure the EmbracePlus until you feel a soft pressure 4 Assure that the sensors are in contact with your skin 5 Check that the green light from the case is not visible through the skin IMPORTANT Make sure the EmbracePlus fits snugly but not too tightly Only wear the EmbracePlus on intact skin Do not use the EmbracePlus with injured...

Page 33: ...se it is suggested to switch the recording location by placing the EmbracePlus on your other wrist Also make sure to clean the EmbracePlus to avoid further irritation In case of an allergic reaction persisting beyond 2 3 days it is suggested to immediately stop using the device and contact the administrator The materials used in the manufacturing of the EmbracePlus are widely used in wearable devi...

Page 34: ...ch consumes little energy and always remains on even if the EmbracePlus is out of battery When EmbracePlus is recording data and connected to the companion app system you will find the following components on the display 1 Time hours 2 Time minutes 3 Bluetooth connection with companion app system Empatica heart 33 ...

Page 35: ... 12 hour clock with no distinction between AM and PM The hour is shown in the outer circle while the minutes are shown in the center of the display The time indicated by EmbracePlus is based on the time of the paired companion app system 34 ...

Page 36: ...ght When EmbracePlus is not recording data the display background will turn dark This behavior is to be expected in the following cases When EmbracePlus is charging For a few seconds after it is removed from the cable charger to calibrate For a few seconds when starting up or rebooting Specific error cases 35 ...

Page 37: ... physiological parameters will not be generated for the user until the EmbracePlus is reconnected CAUTION If EmbracePlus is removed from Bluetooth range it will store data for a maximum of 24 hours After 24 hours no further data will be stored CAUTION Bluetooth connectivity will not work if EmbracePlus is submerged in water and therefore data cannot be transferred to the companion app system 36 ...

Page 38: ... app system the better This ensures that the recorded data are always synchronized EmbracePlus transmits raw data over standard Bluetooth Low Energy 5 0 Physiological parameters are computed by the Companion app system rather than on the EmbracePlus EmbracePlus will continuously collect sensors raw data If the EmbracePlus is removed from BLE range it will store sensor data internally for a maximum...

Page 39: ... no physiological parameters will be generated Note that as EmbracePlus transmits every 60 seconds there is a short period of time between the moment when sensor data is collected and when it is processed by the companion app system into physiological parameters Since the product is not intended for real time monitoring this does not have an impact on the product s intended use 38 ...

Page 40: ...ges onto the cable charger If the cable charger is immersed in liquid stop using it and return it for service WARNING EmbracePlus may only be charged using the cable charger provided by Empatica CAUTION The battery charge level displayed on the EmbracePlus display and in the companion app system user interface is only accurate if the batteries are in normal working condition CAUTION EmbracePlus ca...

Page 41: ...tatus of your battery directly on EmbracePlus How To Check The Battery Percentage By pressing one of the buttons on the right side of the EmbracePlus the time will disappear and the battery percentage will be shown You can go back to the time by pressing one of the buttons otherwise the display will automatically switch back to the current time after 10 seconds 40 ...

Page 42: ...level begins to run low the battery icon will be visible on the display 2 Low battery Charge now When the EmbracePlus battery level is critical 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 buttons 41 ...

Page 43: ...lace in cable charger When completely out of battery the EmbracePlus will turn off The background of the display will turn dark to highlight that data recording has stopped and an empty battery icon will be displayed 42 ...

Page 44: ...2 The cable charger and EmbracePlus will automatically attach through magnets Make sure the display and side buttons are visible while you slide EmbracePlus into the cable charger You will feel a slight pull and EmbracePlus will snap into place 3 Once the charging starts the display background will turn dark and show the available battery percentage A full charge takes about 1 hour and 30 minutes ...

Page 45: ...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 time is shown EmbracePlus is up and running and ready to be used 44 ...

Page 46: ...the user to tag events according to the administrator s instructions To tag an event press one of the side buttons for one second and a checkmark will appear on the display confirming the action The display will then go back to show the time 45 ...

Page 47: ... 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 contamination repeat the cleaning procedure 6 Let EmbracePlus dry before wearing or sanitizing it In order to sanitize the EmbracePlus follow these four simple steps 1 Take a polyester cellulose wipe ...

Page 48: ...pp system 2 The companion app system is within Bluetooth range of 10 meters 30 feet free of any obstacles i e walls heavy fabric to ensure timely data collection Wear the EmbracePlus preferably on your non dominant wrist or according to the instructions of the administrator It is important to always have EmbracePlus charged When the EmbracePlus battery runs low the battery icon will appear on the ...

Page 49: ...ull memory occurs when the EmbracePlus is disconnected from the companion app system for several hours and is unable to synchronize data Make sure Bluetooth is turned on and the companion app system is within the Bluetooth range 10 meters 30 feet to connect the EmbracePlus Once the Bluetooth connection is re established your EmbracePlus will restart data synchronization and record new data 48 ...

Page 50: ...ding Missing companion app system When the background is dark and an X appears the EmbracePlus is missing the companion app system connection Make sure the companion app system has Bluetooth activated and is within range 10 meters 30 feet of the EmbracePlus to re establish a connection Once the companion app system connects the display background will turn light and the Empatica heart will appear ...

Page 51: ...racePlus self reboots to restore proper functioning 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 time will be shown Data synchronization will be automatic and no further action is required 50 ...

Page 52: ... The firmware error may also happen while the EmbracePlus is not recording data shown by the dark display background Press the OK upper button and the EmbracePlus will reboot confirmed by the HI message This should resolve the issue EmbracePlus will also automatically perform a reboot if in case the manual reboot is not confirmed within 10 minutes of pressing the OK button If the firmware error pe...

Page 53: ...e put in hibernation mode Make sure that the environmental conditions are within the operational range 0 50 C of the EmbracePlus Then press the OK upper button and the EmbracePlus will reboot and wake up from hibernation indicated by the HI message In case the critical temperature is detected again after waking up EmbracePlus will re enter the critical temperature state and automatically go into h...

Page 54: ... When this happens the display will freeze due to display limitations showing the last visualization before the error occurred However EmbracePlus will continue to work as expected until 20 C When the temperature goes below 20 C the EmbracePlus will automatically go into hibernation mode Make sure that the environmental conditions are within the operational range 0 50 C before pressing the OK uppe...

Page 55: ...a automatically and require no interaction To ensure smooth data collection make sure you take it off to charge as indicated by the administrator Other than wearing the EmbracePlus correctly and keeping it charged the administrator may also require that you tag events Refer to the administrator s instructions for using the EmbracePlus in your daily life 3 How can I quickly check if the EmbracePlus...

Page 56: ...evice are likewise on If the lights are off then the EmbracePlus is likely to be not recording data as well 4 How can I turn the EmbracePlus on off Once you unbox EmbracePlus and turn it on it will remain ON until it runs out of battery In case it runs out of battery you will see a battery icon on a dark background please place it back in the cable charger and it will automatically switch ON 5 How...

Page 57: ...e it while swimming in saltwater or while using a hot tub sauna or steam room 8 Why has the display of my EmbracePlus turned dark 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 battery has drained 9 How can I check the battery level of the EmbracePlus The battery le...

Page 58: ... icon will stay there until the EmbracePlus is placed in the cable charger When the battery level is critical a message saying low will appear on the center of the display You should place the EmbracePlus in the cable charger as soon as possible 11 I might be allergic to a specific material What is EmbracePlus made of POD Case Polycarbonate Thermal Ring Stainless Steel 316L PPG window Gorilla Glas...

Page 59: ...lease contact the administrator with photos of the affected area Important EmbracePlus should only be worn on the surface of healthy skin Without regular cleaning skin irritation is more likely to occur so please make sure to clean your EmbracePlus regularly 13 How can I receive more assistance Contact the administrator Unless specifically instructed to please do not contact Empatica directly 58 ...

Page 60: ...Care App Care App User Manual English Index Care App 59 ...

Page 61: ...1 Care App at a glance 61 2 Using the Care App for the first time 63 3 Using the Care App in daily life 68 4 FAQs 95 60 ...

Page 62: ... compatible with iOS and Android that serves as a companion to EmbracePlus The Care App streams physiological parameters collected from EmbracePlus to the cloud for further review and storage It also provides the necessary information about the state of EmbracePlus Wearing time and digital biomarkers Depending on the configuration chosen by the administrator 61 ...

Page 63: ...ta collected by EmbracePlus is transferred to the app via Bluetooth b The Care App then transmits the data to the Empatica Cloud via your companion device s internet connection WiFi or cellular data c The data collected can be viewed by a professional or stored to be analyzed at a later stage 62 ...

Page 64: ...App STEP 1 DOWNLOAD THE CARE APP If using a provisioned smartphone Simply activate the internet connection on the companion device given to you by the administrator and the Care App will download automatically If you experience any problem please contact your administrator If using your own smartphone 63 ...

Page 65: ...nd search for Empatica Care Tap on Get it or Download to start the download process STEP 2 OPEN THE CARE APP Open the Care App by tapping its icon on the companion device If you are using a provisioned device and cannot locate the app connect the device to the internet and it should download automatically 64 ...

Page 66: ...p scan the provided QR code or type in the provided Participant ID and Password The app will guide you through the next steps Your login credentials should be given to you by the administrator Reach out to them for further information 65 ...

Page 67: ...on i Click the top button on the right side of EmbracePlus HI or the battery status should appear If nothing happens i e EmbracePlus screen display remains dark ii Put EmbracePlus to charge 1 Plug the charger into a standard 5V USB 2 0 power source 2 Slide EmbracePlus in the charger making sure the buttons are on the outer side 3 EmbracePlus will turn on and display HI 66 ...

Page 68: ...ime on a white background If it is in the charger temporarily remove it to ensure that pairing was successful IMPORTANT in order to pair EmbracePlus with the companion device EmbracePlus must not be connected with another device To check this when out of the charger check if the Empatica heart is visible on EmbracePlus If this is the case you first need to unpair forget it on its companion device ...

Page 69: ...e main screen of the Care App is designed to let you know at a glance if any action is needed and to provide the latest information on your digital biomarkers Digital biomarkers are visible depending on the configuration chosen by the administrator 68 ...

Page 70: ...the system working status The background of the main screen is intuitively color coded so that you can quickly understand the status of the system Teal Care and EmbracePlus are working correctly Yellow Data is being collected but something with the Care App and or EmbracePlus needs your attention Red Data collection and or transfer has stopped you need to take action 69 ...

Page 71: ...atus The Status card in more detail The first card that you see in the Care App displays the status The following outlines the meaning behind each status and what action is needed if any Image Message Meaning Issues Action s Care is working correctly The Care App and EmbracePlus are working correctly and the system is running fine None no action is needed 70 ...

Page 72: ...syncing EmbracePlus is syncing data stored in its memory with the companion device This is likely to happen after EmbracePlus has been disconnected from the companion device Bluetooth was off the companion device was switched off or the EmbracePlus and companion device were not within 10 meters 30 feet of each other Keep EmbracePlus close to the companion device 71 ...

Page 73: ...nion device EmbracePl us is charging The Care App will notify you when the battery is fully charged None EmbracePl us is charged EmbracePlus battery is fully charged and it is ready to be used Remove EmbracePlus from the charger to keep collecting data 72 ...

Page 74: ...rsion of the Care App is available Tap the Status Card to see tips on how to address the underlying issue 1 Check if the status of your mobile device s internet connectivity 2 Install the latest version of the Care App EmbracePl us not worn You are not wearing EmbracePlus or it is not positioned properly on your wrist Wear the device and adjust the fit to ensure it is snug on your wrist 73 ...

Page 75: ...lus are not working Possible causes 1 EmbracePlus might not be connected to the mobile phone 2 The Bluetooth of the mobile device might be off 3 EmbracePlus is out of battery 1 Make sure EmbracePlus is switched on 2 Make sure the mobile device s Bluetooth is turned on 3 Make sure the EmbracePlus and mobile device are within 30 feet of each other 74 ...

Page 76: ...racePl us memory is full The EmbracePlus internal memory is full and therefore it cannot collect and record data Keep EmbracePlus close to your companion device to free up memory and resume data collection 75 ...

Page 77: ...Performing a status check Tapping the Status Card allows you to go into more detail and troubleshoot any issues 76 ...

Page 78: ...ed off or if it has disconnected from the app not within Bluetooth range or Bluetooth off In addition all the other EmbracePlus indicators EmbracePlus battery wearing will change to Not detectable Memory full This warning will appear when the memory of EmbracePlus is full and the data collection has stopped EmbracePlus display will be dark and show the letter M Keep EmbracePlus connected to the co...

Page 79: ... Your EmbracePlus has limited battery left Charge it whenever it is possible Low Your EmbracePlus will soon run out of battery and switch off Please charge it as soon as possible X charged Your EmbracePlus is charging and so far X of its battery has been charged Fully charged Your EmbracePus is fully charged and you can now put it on Not detectable Your EmbracePlus is not connected and or out of b...

Page 80: ...t detectable EmbracePlus is disconnected from the companion device and therefore the wearing status cannot be detected Make sure it is nearby and charged Not available EmbracePlus is connected however due to data syncing the real time wearing status cannot be shown The total Wearing time is updating while the data sync is happening Getting ready Care is initiating Wait a few minutes to view digita...

Page 81: ...cePlus Alternatively you can tap Enable Bluetooth on Android devices to turn the Bluetooth on On iOS devices tapping on Enable Bluetooth will lead you to the Bluetooth settings so you can activate it Bluetooth disabled Please ensure that the Bluetooth is enabled from the settings of the companion device Location disabled On Android devices location services are required to be enabled in order for ...

Page 82: ...it Outdated version The Care App installed on the companion device is an old version and must be updated Please go to the App store or Play Store and update it Stopped working The Care App installed on the companion device is no longer supported Please go to the App store or Play Store and update it to be able to use it again If you are using a provisioned smartphone please contact your administra...

Page 83: ...n device is connected to a WiFi network which has no access to the internet e g printer WiFi airport WiFi Go to the WiFi settings to identify the issue or alternatively switch to another WiFi or cellular network Empatica servers are not reachable Please wait for the service to resume this should only last a few minutes 6hr no connection The companion device has not connected to the internet for mo...

Page 84: ...biomarkers section contains the physiological parameters gathered from the EmbracePlus Data frequency is 1 minute meaning that the values you see are calculated from the samples available in the last 60 seconds 83 ...

Page 85: ...rate and Skin temperature pull up the grey line that s right on top of the Status Card In case EmbracePlus is not connected or not worn correctly the digital biomarker icons will become gray Check the EmbracePlus status to identify the issue and to see what steps you should take to make the digital biomarkers active again When the Care status reads EmbracePlus is syncing the digital biomarkers wil...

Page 86: ...mperature including median Skin temperature for the last 6 hours Shows the value of your Skin temperature over the last minute as measured from your wrist To get a good reading the back of the EmbracePlus should always be in contact with your skin Please note that peripheral temperature is usually different from your core body temperature i e the temperature you read when you measure a fever as it...

Page 87: ...INGS SCREEN In order to access the Settings screen of the Care App tap the 3 dots on the top right of the main screen From here you will be able to visualize additional information about your EmbracePlus 86 ...

Page 88: ...s serial number that is paired with your companion device You can also find it on the back of the EmbracePlus Firmware version The version of the device firmware running on the EmbracePlus 3 Preferences Notifications Allows you to control the notifications that you receive on the Care App By default all of the notifications are toggled on which is the recommended setting 4 About User manual Link t...

Page 89: ...e EmbracePlus from your companion device it will disconnect resulting in data loss In order to reconnect to the device you will need to re pair the EmbracePlus from the beginning see step 4 in chapter 2 Logout Allows you to sign out of the Care App Please note that if you log out your EmbracePlus will stop collecting data resulting in data loss To reconnect log back in using the credentials given ...

Page 90: ...now Appears when your EmbracePlus is almost out of battery The EmbracePlus display will show the low message Charge your EmbracePlus to keep using it 2 Low battery Appears when your EmbracePlus battery is running low The EmbracePlus display will show the empty battery icon Charge at your earliest convenience to avoid data loss 3 Fully charged Appears when your EmbracePlus has been in the charger a...

Page 91: ...o transmit collected data to the cloud EMBRACEPLUS NOT WORN Notifies you when the EmbracePlus does not appear to be on wrist Wear your EmbracePlus to resume data collection If you see this notification while you are wearing EmbracePlus adjust its fit to ensure the sensors are in contact with the skin CARE HAS BEEN CLOSED Notifies you when the Care App has been closed The Care App needs to be const...

Page 92: ...fore no data is being recorded EmbracePlus display will be dark and show the letter M Make sure EmbracePlus is connected to your companion device for at least X hours You can check the progress of the data sync in the status card CARE APP UPDATE Care not updated This version of Care App will stop working soon Please update your App or contact your administrator Update available A new version of th...

Page 93: ...Your version of the app is obsolete and needs to be updated now Please update your App or contact your administrator 92 ...

Page 94: ...ce and you will also be notified on the Care App s main screen You can open the app to verify the status at any time 2 Why does the Care App need to run in the background on my companion device The Care App needs to run in the background to continuously receive the physiological parameters collected from the EmbracePlus and upload them to the Empatica Cloud If the Care App doesn t run in the backg...

Page 95: ... already be installed contact your administrator for further instructions Otherwise visit empatica com start care or open the store on your smartphone Apple Store if iOS Google Play if Android and search for Empatica Care Tap on Get it or Download to start the download process 5 Why can t I download the Care App Not enough space on the companion device A possible reason for not being able to downl...

Page 96: ...evice if the account is set for a user aged 13 years old or younger Disable restrictions if any and try to download the Care App again 7 Why is the Care App requesting location services to be enabled On Android devices the Care App needs the location services on the companion device to be turned on and enabled to pair with the EmbracePlus This is necessary in order to allow the companion device to...

Page 97: ...tion Red Data collection and transfer has stopped you need to take action 9 What does Wearing time mean Wearing time indicates the time for which the EmbracePlus has been worn since midnight of the current day This value is based on the EmbracePlus detecting whether it has been on the wrist or not 10 Sometimes the Wearing time does not reflect the actual time I ve worn EmbracePlus for How is that ...

Page 98: ...ime counter will reset every day at midnight 11 What should I do if I have been logged out of the Care App If a new log in to the Care App is necessary just tap on Login with QR code and frame the QR code provided by the administrator with the camera of the companion device Alternatively you can manually insert the Participant ID and Password that were given to you Once logged in the Care App will...

Page 99: ...ode needed to log into the Care App What should I do If you lost the QR code you can still log in to the Care App by typing in the provided credentials Participant ID and Password If you do not have access to these contact the administrator and ask them to send your credentials Empatica Support Center 98 ...

Page 100: ...The Empatica support center can be reached by sending an email to support empatica com or by calling 1 866 739 2049 99 ...

Page 101: ...nge 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 6 60 rpm Resolution 1 rpm Accuracy 3 rpm Arms Temperature Range 0ºC 50ºC Resolution 0 1ºC Accuracy 0 1ºC within 30 0ºC 45 0ºC range Electrodermal Activity Range 0 01 μSiemens 100 μSi...

Page 102: ...cted an earlier sleep onset and a later sleep offset with an overall longer sleep period duration compared to PSG SpO2 Range 70 100 Resolution 1 Accuracy 3 Arms Technical Specifications EmbracePlus Case POD Diameter 32 mm 1 26 in Thickness 15 mm 0 59 in Weight 38 gr 1 34 oz including battery band and electronics Color Black with a matte finish Materials Case in Polycarbonate and mechanical side bu...

Page 103: ...ecorded data will be transferred to the companion app system as soon as the connection is re established EmbracePlus is dust tight meaning dust will not enter the inner part of the device EmbracePlus pin buckle band Min wrist circumference 132 mm 5 2 in Max wrist circumference 195 mm 7 68 in Width 22 4 mm 0 88 in Color White Materials Biocompatible silicone rubber and electrodes in stainless steel...

Page 104: ... depends on the sensor configuration 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 synchr...

Page 105: ...truments TMP117M Range 0 50 C Resolution 0 01ºC Accuracy 0 1ºC within 30 0ºC 45 0ºC range medical application calibration Sampling Rate 1 Hz 4 Hz Accelerometer and Gyroscope Sensor Type High precision 3D microelectromechanical accelerometer and gyroscope Range 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 8...

Page 106: ...ooth 5 0 with 2M PHY is supported from Android 9 0 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 105 ...

Page 107: ... 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 Use Conditions Temperature Use 10ºC to 40ºC Charging 0ºC to 40ºC Humidity 20 95 Relative Humidity non condensing Pressure 1060 hPa to 700 hPa NOTE After storage at the extreme temperature indicated in the table above allow the device to retur...

Page 108: ...n 30 minutes Avoid using EmbracePlus in a hot tub sauna or steam rooms Please note that the Bluetooth connectivity will not work if EmbracePlus is submerged in water and thus data cannot be transferred to the paired companion app system Recorded data will be transferred to the paired companion app system as soon as the connection is re established EmbracePlus is dust tight meaning dust will not en...

Page 109: ... only use EmbracePlus with the accessories provided Please check EmbracePlus and the cable charger before using it If you see any damage please set it aside and contact your administrator for a replacement If at any point your EmbracePlus or cable charger is damaged please contact your administrator to have it replaced Please do not place any part of EmbracePlus or the cable charger in your mouth ...

Page 110: ...us Please wear EmbracePlus only on your wrist Do not wear it over open wounds sores or cuts 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 Do not use EmbracePlus in a hot tub sauna or steam rooms EmbracePlus is a medical wear...

Page 111: ...ng EmbracePlus inspect the cable charger If you notice any damage the cable should not be used Contact your administrator for replacement When charging EmbracePlus connect the cable charger only to an IEC 60950 certified 5V USB power supply Before charging please check the charging contacts on EmbracePlus and the cable charger and if dirty clean with a dry cloth 110 ...

Page 112: ...y EMPATICA Device Serial Number S N 123456789 IP Classification Water Resistant IP67 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 2AGGH EMBPLUS CE Mark and identification o...

Page 113: ...Care App labeling Care App labeling information is included in the product itself The Regulatory and Compliance page can be accessed from the Settings screen of the Care App 112 ...

Page 114: ...The Regulatory and Compliance page contains the following information Product name App version Release year UDI DI Intended use Legal manufacturer information CE mark 113 ...

Page 115: ...nces Requirements and tests IEC 60601 1 6 2010 Amd1 2013 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability IEC 60601 1 11 2015 Medical electrical equipment Part 1 11 General requirements for basic safety and essential performance Collateral standard Requirements for medical electrical equipment and medical electrical...

Page 116: ...ization FCC 47 CFR Part 15 Radio Frequency Devices IEC 62133 2 2017 Secondary cells and batteries containing alkaline or other non acid electrolytes Safety requirements for portable sealed secondary lithium cells and for batteries made from them for use in portable applications Part 2 Lithium systems 115 ...

Page 117: ...opulation age limitations apply based on the regulatory clearance obtained that want need to monitor their physiological parameters at home or in healthcare environments excluding high acuity environments such as an ICU or operating room Physiological Parameters might be retrospectively reviewed by Healthcare providers or researchers 116 ...

Page 118: ...ion of wrist circumference Nationality not relevant Health status The product is not indicated for use on acutely ill cardiac patients with the potential of developing life threatening arrhythmias Users minimum age varies based on the country The minimum is 2 years and up in the EU and 18 years and up in the US PROFESSIONAL POPULATION Healthcare professionals Occupational doctors Clinical Research...

Page 119: ...ession is defined as a time period during which the user is correctly wearing a device with the purpose of acquiring data for reaching its intended use Evaluation of missing data are performed via a specific data portal by a healthcare professional The connection between EmbracePlus and the companion app system can be lost for a maximum of 5 of the time but the EmbracePlus should be able to automa...

Page 120: ...ponents damage user errors or low algorithm performance Low risk level no significant harm On board memory state of the art electrical design fault detection algorithms and clear user experience have been implemented to mitigate the risk Moreover the EmbracePlus is not intended to diagnose a disease only trained personnel may interpret the data Physiological Parameters computation including any ha...

Page 121: ...se of non biocompatible construction material Low risk level no significant harm EmbracePlus is made of a well known biocompatible material biocompatibility tests have been performed according to relevant regulatory standards EmbracePlus Safety including any hazard that might result from electrical and mechanical failure Low risk level no significant harm EmbracePlus has been designed developed an...

Page 122: ...ues and materials that can withstand a wide range of environmental conditions Indication of the environmental conditions in which the device shall be stored and used are presented in this manual 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 ...

Page 123: ...te of the art techniques BENEFITS The known and potential benefits of EmbracePlus for clinical use are The Remote monitoring capabilities enabled by EmbracePlus could reduce the caregivers risk of exposure to potential health risks Facilitate users remote health status control without the need of hospitalization BENEFITS RISK DETERMINATION Based on the presented known benefits and the residual sev...

Page 124: ...D Case 1 Polycarbonate Injection molding Thermal Ring 1 Stainless Steel 316L Metal Injection Molding CNC PPG Window 1 Gorilla Glass 3 Molding and Ion exchange POD Buttons 2 Thermoplastic Polyurethane Injection Molding E Ink Display Window 1 Gorilla Glass 3 Molding and Ion exchange Band 1 Biocompatible Silicone Rubber Injection molding EDA electrodes 2 Stainless Steel 316L CNC Buckle 2 Stainless St...

Page 125: ...ers have the most secure and comfortable experience when using them It is therefore unlikely that users will develop an allergic reaction from EmbracePlus However some people may notice a slight reaction on their skin If this happens please contact the entity that provided EmbracePlus to you with a picture of the affected area s 124 ...

Page 126: ...lus 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 125 ...

Page 127: ...erefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission CISPR 11 Class B The EmbracePlus device is suitable for use in domestic establishments and in establishments directly connected to the low voltage power supply network that supplies buildings used for domestic purposes Harmonic Emission EN 61000 3 2 Not Applicable Voltage F...

Page 128: ... for use in the electromagnetic environment specified below The user of the EmbracePlus should assure that it is used in such an environment Immunity Test IEC 60601 test level Compliance Level Electromagnetic environment guidance Electrostatic Discharge ESD EN 61000 4 2 8 kV contact 2 4 8 15 kV Air IEC 60601 1 2 Test level Floors should be wood concrete or ceramic tile If floors are covered with s...

Page 129: ...cy 50 60 Hz Magnetic Field EN 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Interference may occur in the vicinity of equipment marked with the following symbol 128 ...

Page 130: ... interference by maintaining a minimum distance between portable and mobile RF communication equipment transmitter and the EmbracePlus as recommended below according to the maximum output power of the communication equipment 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...

Page 131: ...ing specification 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 Empatica suggests having only EmbracePlus connected to the mobile device via BLE connection for optimal system usage Data transfer to the C...

Page 132: ... device at the same time Care App connects to the Care Portal through a cellular WiFi connection Quality of Service of this connection is dictated by your cellular plan Data transfer to the Care Portal might be delayed in case of poor cellular coverage WiFi issues or limited cellular data plan 131 ...

Page 133: ...one 39 02 36566473 Website www empatica com EmbracePlus is manufactured in the Republic of Korea ELECTRONIC LABELING INFORMATION A PDF copy of this Instruction for Use is available at http empatica com manuals In case you want a paper copy of this Instruction 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 132 ...

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