800778-1.3, EMOTION FAROS SERIES MANUAL DOC eMotion...  800778-1.3, EMOTION FAROS SERIES

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Transcript of 800778-1.3, EMOTION FAROS SERIES MANUAL DOC eMotion...  800778-1.3, EMOTION FAROS SERIES

  • 800778-1.3, EMOTION FAROS SERIES MANUAL.DOC

    Mega Electronics Ltd 2014 800778-1.3

  • 800778-1.3, EMOTION FAROS SERIES MANUAL.DOC

    Contents 2 (28)

    Contents

    Contents ........................................................................................................................................................... 2

    1. Introduction............................................................................................................................................... 4

    1.1 General Safety Precautions ................................................................................................................ 4

    1.2 Warnings ............................................................................................................................................. 4

    1.3 Symbols............................................................................................................................................... 5

    2. Faros ECG Sensor overview ................................................................................................................... 6

    2.1 General ................................................................................................................................................ 6

    2.2 Accessories and Replacement Parts .................................................................................................. 7

    2.3 Faros Technical Specification ............................................................................................................. 8

    2.4 Sensor Light Indicators and States ..................................................................................................... 9

    2.5 Recharging the Battery ..................................................................................................................... 10

    2.6 Troubleshooting ................................................................................................................................ 12

    3. Measurement Preparation ..................................................................................................................... 13

    3.1 Heart Rate Variability Acquisition ...................................................................................................... 14

    3.2 Offline ECG Data Acquisition ............................................................................................................ 15

    3.3 Online ECG Mode ............................................................................................................................. 16

    4. Measurement .......................................................................................................................................... 17

    4.1 Stingray adapter and Textile Belt Placement .................................................................................... 18

    4.2 ECG Electrode Placement ................................................................................................................ 19

    AHA ECG Electrode Placement ................................................................................................................... 20

    IEC ECG Electrode Placement .................................................................................................................... 21

    5. Measurement Data Review .................................................................................................................... 22

    5.1 View Logged Offline Data ................................................................................................................. 22

    5.1 Online Data View .............................................................................................................................. 23

    6. Maintenance and Service ...................................................................................................................... 24

    6.1 Cleaning ............................................................................................................................................ 24

  • 800778-1.3, EMOTION FAROS SERIES MANUAL.DOC

    3 (28) Contents

    7. Frequently Asked Questions (FAQ) ..................................................................................................... 25

    How do I know that the battery of the device is fully charged? .................................................................... 25

    In my last measurement the time and date of the measurement were totally wrong. Why is that? How can I fix this problem? ........................................................................................................................................... 25

    How can I open a measurement file recorded with eMotion Faros sensor with the eMotion LAB software? ..................................................................................................................................................................... 25

    Do I need a software for downloading measurement data from the sensor? .............................................. 25

    How can I reset my eMotion Faros device? ................................................................................................. 25

    How can I change the measurement modes of the device? ........................................................................ 26

    Which data format I should choose for my measurement, SDF (Suunto Data Format) or EDF (European Data Format)? .............................................................................................................................................. 26

    What might be the reason for bad quality measurement data? ................................................................... 26

    What is the suitable sampling frequency when measuring ECG? ............................................................... 26

    My Faros sensor does not start, what might cause this problem? .............................................................. 26

    8. Regulatory information .......................................................................................................................... 27

    8.1 Intended use ..................................................................................................................................... 27

    8.2 Classification ..................................................................................................................................... 27

    8.3 Declaration of Conformity .................................................................................................................. 27

    Manufacturer .................................................................................................................................................. 28

    Distributor ...................................................................................................................................................... 28

  • 800778-1.3, EMOTION FAROS SERIES MANUAL.DOC

    Introduction 4 (28)

    1. Introduction The eMotion Faros Sensor is a wearable, portable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research. Faros sensor is a compact wireless solution for Electrocardiography (ECG) and Heart Rate Variability (HRV) applications. The Sensor records data acquisition or communicates remotely with Bluetooth enable device. ECG and HRV measurements can be done by using Faros Sensor with Stingray adapter and Textile Belt or Cable Set and commercially available single-use snap on ECG electrodes. The eMotion Faros Sensor can be used with eMotion LAB, eMotion ECG Mobile software or with other applicable OEM-software. Measurement data can be viewed also in MatLab. Before operating the eMotion Faros, please read this manual thoroughly and retain it for future reference.

    1.1 General Safety Precautions

    eMotion Faros Sensor is not waterproof

    Do not use Sensor in an environment with extreme humidity or temperature (e.g. in shower

    or while swimming)

    Do not disassemble, try to repair, or modify sensor

    Sensor operates solely on acquisition of Electrocardiograph and Physical Activity data

    Sensor does not have any electrical stimulation capabilities

    eMotion Faros does not provide any automatic analysis or diagnosis

    Faros users in the USA please note: For Research Use Only. Not for use in diagnostic

    procedures. Device may be used for non-clinical laboratory research.

    1.2 Warnings

    Sensor is not suitable for direct cardiac application

    Do not attempt self-diagnosis or self-treatment based on acquisitioned data

    Not suitable to use in MRI environment

    The device is not intended to be used at the same time with high frequency (HF) surgical

    equipment or with defibrillator

    This device is not to be used with patients, who have active implantable medical device

    (like heart pacemaker etc.)

    When operating with the eMotion Faros ECG Sensor, do not touch parts of the computer,

    docking station or any non-medical electrical equipment and the patient at the same time.

    To avoid danger of electrical shock and electromagnetic disturbances the computer and

    associated equipment used with the eMotion Faros ECG Sensor should comply with

    IEC/EN 60950 (IT and office equipment safety) or EN60601-1 (Medical electrical equipment

    safety) standard. If a computer that does not comply with the IEC/EN 60601-1 requirements

    is used at the patient envi