Empatica E4 User Manual
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Empatica E4 User Manual

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2018
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Summary of Contents for Empatica E4

  • Page 1 user’s manual 2018 ©...
  • Page 2 2018 ©...
  • Page 3 START T RAC KING NOW empatica.com/get-started-e4 2018 ©...
  • Page 4 INTRODUCTION The E4 wristband is a class IIa Medical Device in the EU, according to CE Cert. No. 1876/MDD (93/ 42/EEC Directive) The Empatica E4 wristband is a wearable E4 Realtime is a mobile App that provides • wireless device designed for comfortable, con - wireless streaming and visualization of tinuous, real-time data acquisition in daily life.
  • Page 5 INTENDED USE AND USERS Indication for use statement The E4 is intended to be worn on the wrist for continuous collection of physiological data in the home and healthcare setting for use by healthcare professionals. This includes blood volume, heart rate and physical activity. The E4 is also intended for the measurement of electrodermal response and physical activity in patients with neurological disorders such as epilepsy.

  • Page 6: Precautions For Use

    A. PRECAUTIONS FOR USE The list below represents all aspects that should be considered as cautions resulting from Risk analysis of the E4. The user is required to carefully read this manual before using the device. – including any error that might result from errant read and /or transfer of data that affects the output of one or more sensor (i.e., Heart rate, EDA, Temperature, Accelerometers).
  • Page 7 This is probably due to the mechanical interference between the skin and the device (the E4 passed all biological safety tests). Thus in this situation it is suggested to stop the recording or switch the recording location, by placing the E4 in the other wrist.
  • Page 8 - 100-500lx, Visual distance: 20-40 cm, Visual angle +-90° Use frequency MR Environment - The Empatica E4 has not been evaluated for safety and compatibility in the MR environment. The Empatica E4 has not been tested for heating or migration in the MR environment. EMC Environment : 2007...
  • Page 9 B. GENERAL AGREEMENTS Empatica E4 wristband is intended for use in Empatica does not handle any personal research settings; therefore we distinguish the information linked to physiological data on Customer, who is usually a researcher managing its servers; all physiological data will be de-...

  • Page 10: Manufacturer Details

    Personal use: In this scenario the patient and operator are equivalent. The patient uses the E4 as a monitoring tool. Professional use: In this scenario the E4 is prescribed by a medical professional to a patients in order to monitor their physiological data and conduct studies on those data.
  • Page 11 FCC CFR 47 Part 15b ed IC (Industry • • Canada) ETSI EN 301 489-17 V2.2.1 • Usability IEC 60601-1-6:2010 (third edition) • ¹ Empatica devices have an integrated Bluetooth® module from which the FCC id is inherited 2020 ©...
  • Page 12 Compliance of the E4 product with the Waste Electrical and Electronic Equipment Directive. E4 has two metal contact points that are used by the EDA sensor. This is type BF part which means that it may generate a leakage current when in contact with the skin.

  • Page 13: Warranty And Support

    F. WARRANTY AND SUPPORT The E4 is covered by warranty as stated by the general sale terms, where the modalities are described by which a broken or defective device can be returned to Empatica. If a malfunction arises during the warranty coverage period and the malfunction belongs to one of the categories listed in the warranty statement, Empatica, after a proper test of the device, will replace or repair it.
  • Page 14 The E4 is shipped in a carton box, which can be recycled after the unpacking. Each carton box may contain one or more devices which are stored inside their original plastic box. When the E4 is not in use it’s advised to place it inside its original plastic box to prevent any accidental damage.

  • Page 15: Package Contents

    1. PACKAGE CONTENTS The package of E4 contains: 1 E4 wristband - adjustable size 1 USB dock (for charging and data transfer) 1 pair of silver (Ag) plated electrodes (installed) 1 pair of silver (Ag) plated replacement 1 USB cable (type MICRO–B)
  • Page 16 2. E4 WRISTBAND OVERVIEW The E4 is worn like a wristwatch. All of the sensors are embedded in the device: the PPG sensor and the temperature sensor are on the bottom side of the device while the wristband holds the EDA electrodes.

  • Page 17: Technical Specifications

    • Electrode longevity: • Tolerates external lighting conditions. • 4–6 months Infrared thermopile • Sampling frequency: 4 Hz (Non customizable). E4 operating range: • Range: • -40...85°C for ambient temperature (if available)*. • Relative Humidity 60 ±25% H.R. • -40...115°C for skin temperature.
  • Page 18 Charger length 1.77 • Life expectancy: 2 years • Charger width 1.73 • Fully charge the E4 battery at least once a month • Charger height 0.47 for optimal performance. When the device is stored inside it’s original box. Materials •...
  • Page 19 • Glass Fiber 30% It’s forbidden to use the E4 with injured skin or other types of skin diseases located in the area where you plan to wear the E4. Among all E4 users (thousands) we have been reported with two cases of allergic reactions of light intensity (few days of persistence).

  • Page 20: Battery Charging

    3. BATTERY CHARGING The E4 must be charged using a standard 5V USB 2.0 power source. In order to charge the device you have to use the charging dock provided from Empatica. Connect the included USB cable to the Micro-B port of the charging dock, connect the charging dock to the E4, and then plug the USB cable into the power source.
  • Page 21 Low battery level. alternating During streaming. Low battery level. alternating The only way to see the battery level of the E4 is to put it in streaming mode. The battery level can be viewed in the E4 realtime app. 2020 ©...
  • Page 22 4. WEARING THE E4 WRISTBAND Wearing the device is as easy as wearing a watch. Wear the E4 with the case on top of your wrist. Wear it snugly, so that it does not move around, but not so tight that it is uncomfortable.
  • Page 23 Follow these steps to attach the band: 1 - Slide loop towards the case. 3 - Wrap the band around the wrist. 2 - Place the E4 top-down on a surface. 2018 2020 © ©...
  • Page 24 The E4 is controlled with a push button interface Status is viewed from the E4’s multi-color LED indicator light BUTTON STATUS LIGHT The E4’s push button interface will trigger different actions depending on the duration of the button press. PRESS HOLD <...
  • Page 25 The E4’s LED light will generally appear BLACK. Yellow light indicates the battery is charging (when the E4 is worn). Alternating yellow and blue lights signify that the battery is charging, while connected to E4 manager. A fixed yellow light indicates the battery is charging when attached to a power source.
  • Page 26 Working in streaming mode Install the E4 realtime app on your Bluetooth(R) Smart ready iOS or Android device (search for “E4 realtime” in Google Play or the App Store). Once installed, connect the E4 with a mobile device using E4 realtime app to: View sensor data in real time.
  • Page 27 Working in recording mode For easy everyday use of the E4 you can record data on the go and sync it once a day. Recording mode allows you to record data and analyze it later. Download E4 manager from and follow the installation instructions.
  • Page 28 Access your web dashboard Login to your Empatica connect account at: View, manage, and download all of your E4 sessions through the Empatica connect web • dashboard. View session details by time series for each signal type (EDA, BVP, HR, TEMP and ACC) with •...
  • Page 29 No reset is possible. No LED light procedure outlined Warranty and Support section above. If the device is not responsive or failing to behave as described above after powering off and let the Empatica Support team know by emailing 2020 ©...

  • Page 30: Taking Care Of Your Device

    8. TAKING CARE OF YOUR DEVICE The E4 and all its accessories were been cleaned before shipment but must be considered all non- sterile. Before switching between Users, and it is recommended that every week, carefully clean all parts of the device that come in contact with the skin. The disinfection processes should include one or more of the following methods: Exposure to UV lamp.
  • Page 31 2020 ©...
  • Page 32 Via Stendhal 36, 20144 Milano (MI) www.empatica.com @empatica #UM-16Rev.2.0 20201020 0051 2018 ©...

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