Page 1 Patient Instructions for use Empatica Health Monitoring Platform Patient instructions for use English | UM-74 | Rev 2.0, June 2022...
Page 2: Table Of Contents
Content — Introduction Intended use Indication for use 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...
Page 3: Introduction
Introduction The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software analytics platform intended to be used by trained administrators to remotely monitor physiological parameters in ambulatory users in home-healthcare and professional healthcare environments. Hardware component...
Page 4 Software component The system has two software components: CARE APP Available on: Apple iPhones 8 or higher running iOS 11 or higher 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.
Page 5: Intended Use
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 used in high-acuity environments such as an ICU or operating room.
Page 6: Indication For Use Statement
Indication for use statement The Empatica Health Monitoring Platform is a wearable health monitor and paired mobile and cloud-based software analytics platform intended to be used by trained healthcare professionals or researchers to remotely monitor physiologic parameters in ambulatory users in home-healthcare and professional healthcare environments.
Page 7 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.
Page 8 The Empatica Health Monitoring Platform is not intended for use in calculating Pulse Rate Variability in patients that are or might be affected by cardiovascular diseases. The Empatica Health Monitoring Platform does not include and is not intended for automated arrhythmia analysis.
Page 9: Documentation Features
Notiﬁed Body responsible for the CE Certiﬁcation Process Indicates that The EmbracePlus uses electromagnetic interference Bluetooth Low Energy to from the EmbracePlus is under transfer data. the limits that are approved by the Federal Communications Commission EmbracePlus is an electrical Indicates device...
Page 10 Symbol Description Symbol Description Equipment Directive EmbracePlus has two metal Indicates the need for the contact points that are used by user consult the EDA sensor. This is type BF EmbracePlus instruction part which means that it may for use for important...
Page 11 Companion app/system Throughout this document term companion app/system is used to identify the mobile app (e.g., Care App) installed on the user’s companion device that receive EmbracePlus data via BLE connection...
Page 12: Safety Considerations
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 EmbracePlus in close proximity (12 inches/30 cm) to portable RF communication equipment, including antennas, since they may interfere with...
Page 13 WARNING: Risk of infection. Empatica technical staff can become infected with pathogenic germs. Disinfect and clean EmbracePlus before returning the medical device to Empatica. WARNING: If EmbracePlus is used in a manner not speciﬁed by the manufacturer, the protection, functionalities, and performance they provide could be compromised.
Page 14: Embraceplus Disposal
EmbracePlus disposal WARNING: Risk of infection. EmbracePlus must be disinfected and cleaned before disposal WARNING: EmbracePlus contains a lithium-ion battery. Do not incinerate the device or place 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.
Page 15: Cybersecurity
Communications between the EmbracePlus and the Care 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.
Page 16 In case 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.
Page 17 Your username and password have been provided to you by the operating institution in a document called “participant credentials”. As a user of EmbracePlus and the Care App, you do not have the possibility to change or reset your password. If you are disconnected from the Care App and you are not able to ﬁnd your “participant credential”, contact...
Page 18 DEALING WITH A LOST OR STOLEN EMBRACEPLUS WEARABLE DEVICE In case an EmbracePlus medical device is lost or stolen, please notify your administrator, providing your username. General guidelines for security • It is recommended that any mobile device with the Care App installed also has a device passcode set.
Page 19: Embraceplus User Manual
EmbracePlus EmbracePlus User Manual English...
Page 20 Index EmbracePlus 1. EmbracePlus at a glance 2. Using EmbracePlus for the ﬁrst time 3. Using EmbracePlus in daily life 4. Troubleshooting 5. FAQs...
Page 21 WARNING: EmbracePlus and its attachment pose a choking hazard. The EmbracePlus is not a toy and should not be chewed on or put in your mouth. WARNING: Do not use EmbracePlus if it appears damaged. Check EmbracePlus for sharp edges and damage before each use.
Page 22 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.
Page 23: Embraceplus At A Glance
1. EmbracePlus at a glance 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 continuously analyze acquired data and extract speciﬁc digital biomarkers.
Page 24 How it 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 25 TYPES OF DATA THAT EMBRACEPLUS COLLECTS EmbracePlus seamlessly collects 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...
Page 26: Using Embraceplus For The First Time
2. Using EmbracePlus for the ﬁrst time 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.
Page 27 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.
Page 28 Pair 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.
Page 29 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.
Page 30 If EmbracePlus doesn’t turn on In case your EmbracePlus 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...
Page 31 STEP 3: WEAR EMBRACEPLUS AND START RECORDING DATA WARNING: EmbracePlus should not be placed over a tattoo – doing so may prevent calculation of accurate physiological parameters. CAUTION: The user must wear the EmbracePlus correctly to ensure correct raw data acquisition and physiological parameter computation.
Page 32 1. Wear it on your non-dominant hand (unless otherwise speciﬁed) 2. Place the device 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.
Page 33 EmbracePlus. Do not use the EmbracePlus if it appears to be damaged. EmbracePlus is waterproof and can be worn while exercising or taking a shower. However, Embrace Plus should be removed while swimming in saltwater or while using a hot tub, sauna, or steam room.
Page 34: Using Embraceplus In Daily Life
Display and interaction guide The EmbracePlus display uses E Ink technology, which 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.
Page 35 EmbracePlus has a 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.
Page 36 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 37 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.
Page 38 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 of 24 hours. After 24 hours, no further sensor...
Page 39 When the BLE connection becomes available, EmbracePlus will transmit any internally stored data. It is important to note that while EmbracePlus is out of BLE range, no physiological parameters will be generated. Note that as EmbracePlus transmits every 60 seconds, there is a short...
Page 40 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.
Page 41 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...
Page 42 UNDERSTANDING BATTERY LEVEL WARNINGS 1. Low battery - Charge soon When the EmbracePlus battery 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”...
Page 43 3. Out of battery - Place 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...
Page 44 How to charge EmbracePlus When you need to charge EmbracePlus, follow these simple steps: 1. Use the cable charger included in the EmbracePlus package and plug it into a standard 5V USB 2.0 power source. 2. The cable charger and EmbracePlus will automatically attach through magnets.
Page 45 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 time...
Page 46 How to Tag an Event The EmbracePlus allows 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.
Page 47 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 contamination, repeat the cleaning procedure.
Page 48 ● 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 display.
Page 49: Troubleshooting
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...
Page 50 Not recording - Out of battery When EmbracePlus is out of battery, it cannot record data and therefore the display background will turn dark. Charge your EmbracePlus to start recording data again. Not recording - Missing companion app/system When the background is dark and an ‘X’ appears, the EmbracePlus is missing the companion app/system connection.
Page 51 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 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.
Page 52 Manual Reboot In case there is a ﬁrmware error detected by the EmbracePlus, an exclamation point (!) symbol will appear on the display, indicating 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 53 EmbracePlus will automatically be 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’...
Page 54 It is possible that, while in hibernation, the EmbracePlus will run out of battery. If the EmbracePlus doesn’t turn on after pressing the OK button, place it in the cable charger to charge. Likewise, it is possible that the EmbracePlus reaches a temperature level below 0°C.
Page 55: Faqs
Refer to the administrator’s instructions for using the EmbracePlus in your daily life. 3. How can I quickly check if the EmbracePlus is ON and transmitting data? ● Make sure the display background is light, which indicates that...
Page 56 ● Press one of the side buttons on the EmbracePlus to verify the battery levels. ● If the Empatica heart is visible, the EmbracePlus is synchronizing data via Bluetooth to the companion app/system.
Page 57 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 level of the EmbracePlus can be veriﬁed by pressing...
Page 58 10 seconds. 10. How will I know when to charge? EmbracePlus will show a battery icon on the bottom right of the display when the battery is low. This icon will stay there until the EmbracePlus is placed in the cable charger.
Page 59 ● Buckle: Stainless Steel 316L 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 60: Care App User Manual
Care App Care App User Manual English Index Care App...
Page 61 1. Care App at a glance 2. Using the Care App for the ﬁrst time 3. Using the Care App in daily life 4. FAQs...
Page 62 What the Care App does The Care App is a smartphone application (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*.
Page 63 How it works The Care App is the link between your EmbracePlus and the Empatica Cloud. a. The data 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...
Page 64 2. Using the Care App for the ﬁrst time Getting started Follow these steps to get started with the Care 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.
Page 65 Visit empatica.com/start-care, or open the store on your smartphone (App Store if iOS, Play Store if Android) and 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.
Page 66 STEP 3: LOG IN To access the Care App, 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.
Page 67 Make sure the companion device has Bluetooth and the internet connection (WiFi or cellular network) activated. b. Make sure EmbracePlus is turned on: 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...
Page 68 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 (go to the settings page on the companion device).
Page 69 3. Using the Care App in daily life Main screen The 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.
Page 70 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.
Page 71 Image Message Meaning/Issues Action(s) Care is The Care App and None - no action is working EmbracePlus are needed. correctly working correctly, and the system is running ﬁne.
Page 72 Care is The Care App and Keep the getting EmbracePlus EmbracePlus on ready calibrating. This and the Care App should only take a open. few minutes. EmbracePl EmbracePlus is Keep EmbracePlus us is syncing data stored close to the syncing in its memory with companion device.
Page 73 Keep the Care App open and EmbracePlus near the companion device. EmbracePl The Care App will None us is notify you when the charging battery is fully charged. EmbracePl EmbracePlus Remove us is battery is fully EmbracePlus from charged charged and it is the charger to keep ready to be used.
Page 74 Care App is Care App available EmbracePl You are not wearing Wear the device us not EmbracePlus, or it is and adjust the ﬁt to worn not positioned ensure it is snug on properly on your your wrist.
Page 75 EmbracePl EmbracePlus will Charge us battery soon be out of EmbracePlus as is low battery. soon as possible. Care is not Care App and 1) Make sure working EmbracePlus are EmbracePlus not working. is switched Possible causes: EmbracePlus 2) Make sure...
Page 76 The EmbracePlus Keep EmbracePl internal memory is EmbracePlus us memory full and therefore it close to your is full cannot collect and companion record data. device to free up memory and resume data collection.
Page 77 Performing a status check Tapping the Status Card allows you to go into more detail and troubleshoot any issues.
Page 78 EmbracePlus is within 10 meters/30 feet range, the EmbracePlus will remain connected to the companion device and sync data. When EmbracePlus is syncing, the amount of data syncing will be shown in the status card. Disconnected: This warning will appear if your EmbracePlus is turned off, or if it has disconnected from the app (not within Bluetooth range or Bluetooth off).
Page 79 Full: Your EmbracePlus is charged and the battery is at maximum capacity. X%: Your EmbracePlus has about X% of battery left. Please note that the battery level cannot be visualized if the EmbracePlus is disconnected or has run out of battery.
Page 80 WEARING Worn: EmbracePlus is on wrist and is collecting data. Keep it on. In charger: EmbracePlus is charging. Wear once sufﬁciently charged. Not worn: EmbracePlus is currently off wrist. Place on wrist to collect data. Not detectable: EmbracePlus is disconnected from the companion device and therefore the wearing status cannot be detected.
Page 81 Active: The Care App is receiving data from the EmbracePlus via Bluetooth. Keep your EmbracePlus and companion device charged and within Bluetooth range (10 meters/30 feet) to continue receiving data. Make sure that the companion device has an internet connection so that the Care App can automatically upload the received data.
Page 82 Notiﬁcations disabled: Notiﬁcations are disabled in the companion device’s settings. Please enable them so that the Care App can send you important notiﬁcations. App Update available* - Update is available: A new version of the Care App is available. Please go to the App store or Play Store and update it. - Outdated version: The Care App installed on the companion device is an old version and must be updated.
Page 83 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 more than 6 hours.
Page 84 The Digital 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.
Page 85 Wearing time. The status card will warn you when the device is not worn correctly. If you think the values are incorrect, or you are wearing EmbracePlus but the time is not increasing, please contact the administrator.
Page 86 EmbracePlus should always be in contact with your skin. Please note that many factors can affect the Pulse rate measurement from the wrist, like level and type of physical activity, emotional and cognitive stimuli, and environmental factors.
Page 87 SETTINGS 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.
Page 88 1. Participant information Participant Full ID: The unique identiﬁer that was assigned to you. This ID, as well as the EmbracePlus serial number, can come in handy in case you need to report any issues to the administrator. 2. EmbracePlus Serial number: The EmbracePlus serial number that is paired with your companion device.
Page 89 If you forget the 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.
Page 90 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 and the battery percentage has reached 100%.
Page 91 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.
Page 92 EmbracePlus is charged and connected to resume the data collection. EMBRACEPLUS MEMORY IS FULL Notiﬁes you when EmbracePlus memory is full and therefore 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.
Page 93 Your version of the app is obsolete and needs to be updated now. Please update your App or contact your administrator.
Page 94 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 background, the EmbracePlus will disconnect and the Empatica heart will disappear from the EmbracePlus display.
Page 95 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?
Page 96 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 search and connect to devices over Bluetooth Low Energy technology.
Page 97 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.
Page 98 EmbracePlus is ﬁtted snugly, around 1 inch from the wrist bone, without any obstructions (for example a sleeve or item of jewelry). The Wearing time counter pauses every time the EmbracePlus is loose on the wrist, wrongly placed, obstructed, or removed.
Page 99: Empatica Support Center
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...
Page 100 The Empatica support center can be reached by sending an email to support@empatica.com or by calling 1 (866) 739-2049.
Page 101: Technical Specifications & Performance Characteristics
Technical Speciﬁcations & Performance Characteristics Performance Characteristics Physiological Pulse Rate Range: 24 - 240 bpm Parameters Resolution: 1 bpm measurement Accuracy (no motion): 3 bpm A Accuracy (motion): 5 bpm A PRV - RMSSD Typical range: 0 - 300 ms Resolution: 0.01 ms Accuracy: positive...
Page 102 PSG. Range: 70% - 100% Resolution: 1 % Accuracy: 3% A Technical Speciﬁcations EmbracePlus Diameter: 32 mm / 1.26 in Case (POD) Thickness: 15 mm / 0.59 in Weight: 38 gr / 1.34 oz (including battery, band, and electronics) Color: Black with a matte ﬁnish...
Page 103 (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. Avoid using EmbracePlus in a hot tub, sauna, or steam rooms. Please note that the Bluetooth connectivity will...
Page 104 EmbracePlus Features: Easily interchangeable band standard embedded with Empatica's custom made EDA buckle band sensors. EmbracePlus Type: 3.8V Li-ion Battery Capacity: 155 mAh Battery life: 2 years or up to 500 cycles Charging time (0% to 100%): 90 minutes (worst...
Page 105 110μg/√Hz Accuracy Gyroscope: ±1% on sensitivity, ±0.007%/°C, 3.8mdps/√Hz Sampling Rate: 26 Hz – 208 Hz Electrodermal Type: Custom-built by Empatica (ventral side Activity (EDA) electrodes embedded in the band) Sensor Range: 0.01 μSiemens – 100 μSiemens Resolution: 1 digit ~ 55 pSiemens...
Page 106 Compatibility iOS operative system: iOS 13.4 or higher Bluetooth® 5.0, which is supported from iPhone 8 or newer and iOS 13.4 or higher Android 9.0 or higher Bluetooth® 5.0 with 2M PHY is supported from Android 9.0 or higher (might depend on the speciﬁc manufacturer) Connectivity Main standard: Bluetooth®...
Page 107 1060 hPa to 700 hPa NOTE: After 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.
Page 108 Dust And Water Resistance 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 109 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 as it can be a choking hazard.
Page 110 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.
Page 111 If any redness appears under or around EmbracePlus, stop using it and let your administrator know. Cable Charger Take care when handling the cable charger. Before charging EmbracePlus, inspect the cable charger. If you notice any damage the cable should not be used. Contact your administrator for replacement.
Page 112 Regulatory and Compliance EmbracePlus labeling The information directly printed on the EmbracePlus 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 ●...
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.
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 ●...
Page 115 EmbracePlus laboratory testing EmbracePlus has been subject to speciﬁc laboratory testing to assess its safety, electromagnetic compatibility, usability and biocompatibility. 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 essential performance ●...
Page 116 ● 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: 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...
Page 117 Intended population and use environment The Empatica Health Monitoring Platform is intended to be used by the general ambulatory user’s population (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.
Page 118 Patients population and Medical Conditions USER POPULATION ● Age: from 2 years of age (there might be limitation of wrist circumference for the wearable device) to elderly*** ● Ambulatory Patients ● Weight: not relevant, but there might be limitation of wrist circumference ●...
Page 119 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 automatically reconnect to the companion app/system. The entire EmbracePlus is considered as an “Applied Part”.
Page 120 The list below represents all aspects that should be considered as cautions resulting 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 - including any hazard that might result from sensors failure, electrical components damage, user errors or low algorithm performance.
Page 121 Moreover, the EmbracePlus is not intended to diagnose a disease; only trained personnel may interpret the data. EmbracePlus Cleaning - including any hazard that might result from wrong cleaning procedure or use of non-compatible cleaning agents. Low risk level – no signiﬁcant harm – State of the art validation protocols have been performed to validate EmbracePlus cleaning procedure and listed cleaning agents.
Page 122 EmbracePlus Environmental conditions - including any hazard that might result from the storage or use of EmbracePlus in extreme environmental conditions.. Low risk level – no signiﬁcant harm – EmbracePlus has been designed, developed, and manufactured using state of the art techniques and materials that can withstand a wide range of environmental conditions.
Page 123 EmbracePlus functionalities have been designed, developed, and tested using state 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.
Page 124 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. Part Name...
Page 125 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).
Page 126 Compatibility with MRI and X-ray Scanning WARNING: 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...
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...
Page 128 (FCC Title 47, Subpart A, Part 15.21) 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.
Page 129 cables than recommended minimum separation distance of 30 Power 30 A/m 30 A/m Power frequency Frequency magnetic ﬁelds should be (50/60 Hz) at levels characteristic of a Magnetic typical location in a typical Field commercial or hospital environment. 61000-4-8 Interference may occur in the vicinity of equipment marked with the following symbol:...
Page 130 RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND EMBRACEPLUS EmbracePlus is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the EmbracePlus can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF...
Page 131 Modulation: 5785 217 Hz WIRELESS INFORMATION EmbracePlus connects to the mobile device through a BLE connection with the following 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...
Page 132 as being out of range from the device or having too many devices connected via BLE to the mobile 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.
Page 133 MANUFACTURER INFORMATION Empatica Health Monitoring Platform, EmbracePlus, Care App and Care Portal are manufactured by Name: Empatica S.r.L. Address: Via Enrico Stendhal, 36 City: Milan Zip: 20144 Phone: +39 02 36566473 Website: www.empatica.com EmbracePlus is manufactured in the Republic of Korea...

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