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Empatica E4 User Manual

Empatica E4
32 pages
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1
empaca
©
2015
user manual
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Empatica E4 Specifications

General IconGeneral
SensorsPPG, EDA, Skin Temperature, Accelerometer
Sampling Rate (PPG)64 Hz
Sampling Rate (EDA)4 Hz
Sampling Rate (Skin Temperature)4 Hz
Sampling Rate (Accelerometer)32 Hz
ConnectivityBluetooth Low Energy (BLE)
Charging TimeApproximately 2 hours
Water ResistanceIP67
CompatibilityiOS, Android
Sensor TypePhotoplethysmography (PPG)
Data StorageOn-device storage

Summary

Introduction

Intended Use and Users

Indication for Use Statement

Statement detailing the intended use of the E4 wearable sensor device.

User Types

Defines the different categories of users for the E4 device, such as patient and operator.

User Modalities

Describes the different ways the E4 can be used, such as personal or prescription use.

A. General Agreements

B. Manufacturer Details

C. User Types

Personal Use

Describes the scenario where the patient and operator are the same person using the E4.

Professional Use

Details the scenario where a medical professional uses the E4 to monitor patients.

D. Product Labeling Information

Package Labeling and Symbols Description

Explains the various labels and symbols found on the Empatica E4 product packaging.

E. Warranty and Support

Issues Not Covered Under Warranty

Lists the conditions and damages that are not covered by the Empatica E4 warranty.

Issues Covered Under Warranty

Details the types of manufacturing defects and battery issues that are covered by the E4 warranty.

Support and Frequently Asked Questions (FAQ)

Provides information on how to get support and answers to common questions about the E4.

Return Merchandise Authorization (RMA)

Explains the process for obtaining an RMA to return the product for servicing.

F. Precautions for Use

Synthesis of Cautions

Summarizes all aspects considered as cautions resulting from the Risk analysis of the E4 device.

Device Care and Environmental Considerations

Covers water resistance, biocompatibility, electromagnetic compatibility, and usage conditions.

Handling, Disposal, and Usage Guidelines

Details transport, disinfection, storage, disposal, accessory use, and use with children.

1. Package Contents

2. E4 Wristband Overview

Technical Specifications Overview

Details the technical specifications for the E4's sensors, operating range, and water resistance.

Device Dimensions, Power, and Memory

Covers battery, size, charger, weight, clock, memory, and operating conditions for the E4.

Bio Compatibility and Precautions

Details the E4's components in contact with skin and discusses precautions and allergic reactions.

4. Wearing the E4 Wristband

Attaching the Band

Provides step-by-step instructions on how to attach the E4 wristband.

5. Interacting with the E4

Button and LED Indicator Light

Explains the E4's control interface using a push button and multi-color LED indicator.

Button Interactions

Describes the different actions triggered by the duration of the E4's button press.

LED Status Interactions

Details the meaning of different LED colors indicating battery status, recording, and streaming.

6. Using the E4 Wristband

Creating an Empatica Connect Account

Guides users through the process of creating an account for the Empatica Connect platform.

Working in Streaming Mode

Explains how to use the E4 in streaming mode with the Realtime mobile app.

Working in Recording Mode

Details how to use the E4 for recording data on the go and syncing it later.

Access Your Web Dashboard

Guides users on accessing and utilizing the Empatica Connect web dashboard for data management.

7. Faulty States

Alternating LED Fault States

Describes fault states indicated by alternating LED patterns and their resolutions.

Rapidly Alternating LED Fault States

Details fault states indicated by rapidly alternating LEDs and hardware issues.

No LED Light Fault State

Explains the fault state indicated by no LED light, signifying serious hardware problems.

8. Taking Care of Your Device

Cleaning and Disinfection

Provides methods for cleaning and disinfecting the E4 device for user safety and hygiene.

Types of Electrodes

Describes the two types of user-replaceable electrodes (stainless steel and silver) for the E4.

Replacing the Electrodes

Gives instructions on how to change the E4 electrodes and troubleshooting tips.

9. Software and Hardware Requirements

Empatica Realtime Requirements

Lists the iOS and Android operating system requirements for the Empatica Realtime app.

Empatica Manager Requirements

Details the hardware and operating system requirements for the Empatica Manager application on Windows and Mac.