Mega Electronics eMotion FAROS Series Manual
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Mega Electronics eMotion FAROS Series Manual

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800778-1.4
M
F
S
M
.
E
OTION
AROS
ERIES
ANUAL
DOC
D
: D
15, 2015
ATE OF ISSUE
ECEMBER
© Mega Electronics Ltd 2014-2015
800778-1.4

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Summary of Contents for Mega Electronics eMotion FAROS Series

  • Page 1 800778-1.4 OTION AROS ERIES ANUAL 15, 2015 ATE OF ISSUE ECEMBER © Mega Electronics Ltd 2014-2015 800778-1.4...

  • Page 2: Table Of Contents

    800778-1.4 OTION AROS ERIES ANUAL Contents Introduction............................... 4 General Safety Precautions ........................ 5 Warnings ............................. 5 Symbols............................... 6 Faros ECG Sensor overview ........................7 General ..............................7 Accessories and Replacement Parts ....................8 Faros Technical Specification ......................9 Sensor Light Indicators and States ....................10 Recharging the Battery ........................
  • Page 3 800778-1.4 OTION AROS ERIES ANUAL Frequently Asked Questions (FAQ) ..................... 35 How do I know that the battery of the device is fully charged? ..............35 In my last measurement the time and date of the measurement were totally wrong. Why is that? How can I fix this problem? ............................

  • Page 4: Introduction

    800778-1.4 OTION AROS ERIES ANUAL 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.

  • Page 5: General Safety Precautions

    800778-1.4 OTION AROS ERIES ANUAL 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 bath or while swimming)  Do not disassemble, try to repair, or modify sensor ...

  • Page 6: Symbols

    800778-1.4 OTION AROS ERIES ANUAL 1.3 Symbols The device is CE-marked for the conformity to Council Directive 93/42/EEC regarding medical devices The device is equipped with type BF applied parts fulfilling the EN 60601-1 (IEC60601-1) standard. The additional electrodes are disposable. USE BEFORE The electrodes shall not be used after the date followed this symbol.

  • Page 7: Faros Ecg Sensor Overview

    800778-1.4 OTION AROS ERIES ANUAL 2. Faros ECG Sensor overview 2.1 General eMotion Faros device series is an innovative tool for monitoring ECG, HRV (Heart Rate Variability), stress, recovery and general well-being. Lightweight (13 grams), smoothly designed (48 x 29 x 12 mm) and easy to use eMotion Faros is ideal for instant measurements and also for long-term follow-up.

  • Page 8: Accessories And Replacement Parts

    800778-1.4 OTION AROS ERIES ANUAL 2.2 Accessories and Replacement Parts Part Part number 900826 USB cable is used to data transfer and re- charging the battery. To manage Sensor settings connect eMotion Faros to PC via USB cable. Stingray Adapter Textile Belt: and Textile Belt are 900810...

  • Page 9: Faros Technical Specification

    Figure 3: Faros Technical Specification *Faros Power Source Li-ion battery comply with 62133. Mega Electronics Ltd reserves all rights to improve, change and modify the products and the contents of the User Manual without prior notice. 9 (40) Virhe. Määritä Aloitus-välilehdessä Heading 1;Pääotsikko, jo...

  • Page 10: Sensor Light Indicators And States

    800778-1.4 OTION AROS ERIES ANUAL 2.4 Sensor Light Indicators and States Sensor Light Indicators Pushbutton, powers sensor on / off Battery Indicator Blue Light Measurement and Power on Indicator Green Light Caution Indicator Orange Light Error Indicator Red Light Sensor States State Light indicator Battery charging...

  • Page 11: Recharging The Battery

    800778-1.4 OTION AROS ERIES ANUAL 2.5 Recharging the Battery USB Cable It is recommended to recharge the battery to full capacity before conducting operations or performing data acquisition with the device Make sure that the sensor is completely dry especially the USB connector before you start to recharge your Faros Sensor.
  • Page 12 800778-1.4 OTION AROS ERIES ANUAL Faros Base Charger Station Connect Charger Station to PC via USB Cable delivered with Charger Station. Cable is connected correctly when the Base Charger Station’s Green LED indicator is on. Connect sensors to Charger Station. Sensors are being recharged when Battery LED Indicator (Blue LED) of the sensor(s) start to blink.

  • Page 13: Troubleshooting

    800778-1.4 OTION AROS ERIES ANUAL 2.6 Troubleshooting If device does not work or operation is unpredictable, try following: Recharge the device  Follow instruction in chapter 2.5 Recharging the Battery Device does not start measurement (error light indicator blinks three (3) times) ...

  • Page 14: Measurement Preparation

    800778-1.4 OTION AROS ERIES ANUAL 3. Measurement Preparation With Faros Sensor Manager it is possible to change acquisition configuration. Electrocardiograph data acquisition is possible to perform in offline data logger mode. Data is logged in SDF/ASC or in EDF -format. Online data acquisition is possible to perform with Faros 180 and Faros 360 models.

  • Page 15: Offline Ecg Data Acquisition

    800778-1.4 OTION AROS ERIES ANUAL 3.1 Offline ECG Data Acquisition Offline ECG Data Acquisition can be performed with every Faros model. Configuration for ECG data logger mode is set using Faros Device Manager. 1. Open eMotion Faros Manager (eMotion Faros Manager is locate on Faros internal memory) 2.
  • Page 16 800778-1.4 OTION AROS ERIES ANUAL Figure 7: Example Configuration for ECG data logging with Faros 180 Figure 8: Example Configuration for ECG data logging with Faros 90 Virhe. Määritä Aloitus-välilehdessä Heading 1;Pääotsikko, jota haluat käyttää tähän kirjoitettavaan tekstiin. 16 (40)

  • Page 17: Online Ecg Mode

    800778-1.4 OTION AROS ERIES ANUAL 3.2 Online ECG Mode Online ECG Data monitoring can be performed using Faros 180 or Faros 360 Sensor. Configuration for online mode is set using Faros Device Manager. 1. Open Faros Device Manager (eMotion Faros Manager is locate on Faros internal memory) 2.

  • Page 18: Heart Rate Variability Acquisition

    800778-1.4 OTION AROS ERIES ANUAL 3.3 Heart Rate Variability Acquisition Heart Rate Variability data acquisition can be performed with every Faros model. Setup for data logger mode for HRV acquisition can be set using Faros Device Manager. 1. Open Faros Device Manager (eMotion Faros Manager is locate on Faros internal memory) 2.

  • Page 19: Measurement

    800778-1.4 OTION AROS ERIES ANUAL 4. Measurement The eMotion Faros ECG Sensor has one pushbutton.  The device starts when you push the button.  The device shutdown when you push the button continuously for 5 sec. Faros ECG sensor provides several different measurement options. Measurement options and Faros wearing instructions are descripted below.

  • Page 20: Ecg Electrode Placement

    800778-1.4 OTION AROS ERIES ANUAL 4.1 ECG Electrode Placement The eMotion Faros Sensors are compatible with 4 mm snap connector ECG Electrodes, like Ambu Blue Sensor M-00-S or VLC-00-S. Place the electrodes on the subject according to the instructions illustrated in Figure 12-14 and connect the snap connector electrode wires to the electrodes. The user should be familiar with correct placement of electrodes.
  • Page 21 800778-1.4 OTION AROS ERIES ANUAL ECG Electrode Placements Placement : R / RA IEC Colour: Red AHA Colour: White Placement: F / LL IEC Colour : Green AHA Colour : Red Figure 12: 2-electrode cable set placement 21 (40) Virhe. Määritä Aloitus-välilehdessä Heading 1;Pääotsikko, j...
  • Page 22 800778-1.4 OTION AROS ERIES ANUAL Placement : R / RA Placement : L / LA IEC Colour: Red IEC Colour: Yellow AHA Colour: White AHA Colour: Black Placement: F / LL IEC Colour : Green AHA Colour : Red Figure 13: 3-electrode cable set placement Virhe.
  • Page 23 800778-1.4 OTION AROS ERIES ANUAL Placement : R / RA Placement : L / LA IEC Colour: Red IEC Colour: Yellow AHA Colour: White AHA Colour: Black Placement : C / V IEC Colour: Grey AHA Colour: Brown Placement: F / LL IEC Colour : Green AHA Colour : Red Figure 14:...

  • Page 24: Stingray Adapter And Textile Belt Placement

    800778-1.4 OTION AROS ERIES ANUAL 4.2 Stingray adapter and Textile Belt Placement Faros sensor with Stingray Adapter and Textile Belt can be used to one channel ECG and HRV data acquisition. Connect Faros ECG Sensor to Stingray Adapter. Connect adapter to Textile Belt. Moisten well the belt’s electrode areas with water.
  • Page 25 800778-1.4 OTION AROS ERIES ANUAL Figure 17: Correct Placement of Stingray and Textile Belt 25 (40) Virhe. Määritä Aloitus-välilehdessä Heading 1;Pääotsikko, j...

  • Page 26: Fast-Fix Electrode

    800778-1.4 OTION AROS ERIES ANUAL 4.3 Fast-Fix Electrode The Fast-Fix electrode is intended to be used as an adhesive ECG electrode with eMotion Faros Sensor to perform ECG data acquisition. Electrode is applied directly to patient’s skin to enable acquisition of ECG. Follow instructions presented below for proficient use of the Fast-Fix Electrode.

  • Page 27: Accelerometer Data

    800778-1.4 OTION AROS ERIES ANUAL 4.4 Accelerometer data The data recorded by the in-built accelerometer can be utilized by the user to recognize the movement and non-movement periods from the data acquisition period. The reading from the accelerometer is the acceleration induced by the sum of all forces acting of the device, including gravity, movement of the patient and movement caused by the environment, e.g.

  • Page 28: Emotion Edf Viewer

    800778-1.4 OTION AROS ERIES ANUAL 5. eMotion EDF Viewer 5.1 Measurement Data Review EDF data can be reviewed using eMotion EDF Viewer. Application is located on Faros Sensor internal memory. Open eMotion EDF Viewer 1. Connect your Faros Sensor to computer using USB Cable 2.
  • Page 29 800778-1.4 OTION AROS ERIES ANUAL Review measurement data 1. Click ‘Open EDF’ in main view (Alternative select ‘File’ and ‘Open’) 2. Select desired measurement file a. Browse FAROS_xxx hard drive and open “DATA” folder Folder names indicate the date of performed measurement(s) b.
  • Page 30 800778-1.4 OTION AROS ERIES ANUAL Accelerometer data The physical activity output is raw data from the in-built accelerometer of the Faros sensor. The data recorded by the accelerometer is used to recognize the movement periods (e.g. sports, walking or other physical activity) from the measurement. The accelerometer data itself does not have an effect on the ECG measurement data.
  • Page 31 800778-1.4 OTION AROS ERIES ANUAL User Interface Data window presents the acquisitioned ECG data. Possible events are shown in data. Info window contains Faros sensor configuration which was used in measurement. Manually created event(s) are listed to Event window. Figure 24: Data window 31 (40) Virhe.

  • Page 32: Emotion Edf Viewer Menus

    800778-1.4 OTION AROS ERIES ANUAL Info window presents configuration of acquisitioned ECG data. Duration, start and end time are presented. Figure 25: Info window Events ECG event report is created of inserted events (i.e markers). Click ‘Event Report’ to generate repor of desired events.t A PDF report will be open in separate window having options to print or save.
  • Page 33 800778-1.4 OTION AROS ERIES ANUAL Calibrate To calibrate ‘Data window’ mm-grid view select ‘Calibrate’ from ‘Tools’. Measure the blue rectangle and write the values below. Click ‘OK’. Figure 26: Calibration view Help Help menu contains software related information and manual. 33 (40) Virhe.

  • Page 34: Maintenance And Service

    800778-1.4 OTION AROS ERIES ANUAL 6. Maintenance and Service eMotion Faros ECG sensor doesn’t require any particular maintenance procedure except recharging of the battery. For a correct functioning please follow these simple precautions:  Handle this device carefully  Store the device away from dusty or dirty areas ...

  • Page 35: Frequently Asked Questions (Faq)

    800778-1.4 OTION AROS ERIES ANUAL 7. Frequently Asked Questions (FAQ) How do I know that the battery of the device is fully charged? When the battery is fully charged, the blue LED lights stays on continuously when the device is connected to a computer with micro USB cable.

  • Page 36: What Might Be The Reason For Bad Quality Measurement Data

    800778-1.4 OTION AROS ERIES ANUAL What might be the reason for bad quality measurement data? If you are using disposable electrodes for measurements, the first thing to do is to check whether the electrodes are dry or not. If the electrodes are dry, the quality of the recorded data will suffer. Once you open the bag of electrodes, remember to close it tightly and firmly to avoid drying of the electrodes.

  • Page 37: Regulatory Information

    800778-1.4 OTION AROS ERIES ANUAL 8. Regulatory information 8.1 Classification EU In accordance with MDD 93/42/EEC: Class IIa product EN60601-1: Internally powered equipment 8.1.1 Declaration of Conformity We herewith declare under our sole responsibility that the product listed below is in conformity with the provisions of the Council Directive 93/42/EEC of 14 June 1993 (and the Finnish national laws 1505/94 and 1506/94) concerning medical devices.

  • Page 38: Classification U.s

    800778-1.4 OTION AROS ERIES ANUAL 8.2 Classification U.S Trade/Proprietary Name: eMotion Faros ECG Mobile Regulation Classification: 870.2920 Product Code: Class of Device: Class II Panel: Cardiovascular 510(k) Number: K143032 eMotion Faros ECG Mobile Intended Use in USA The eMotion Faros ECG sensor is a wearable, portable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research.
  • Page 39 800778-1.4 OTION AROS ERIES ANUAL - BLANK PAGE - 39 (40) Virhe. Määritä Aloitus-välilehdessä Heading 1;Pääotsikko, j...

  • Page 40: Manufacturer

    800778-1.4 OTION AROS ERIES ANUAL Manufacturer Mega Electronics Ltd Pioneerinkatu 6 70800 Kuopio Finland Phone +358 (0)17 581 7700 Fax +358 (0)17 580 0978 Mail mega@megaemg.com Website www.megaemg.com Distributor Virhe. Määritä Aloitus-välilehdessä Heading 1;Pääotsikko, jota haluat käyttää tähän kirjoitettavaan tekstiin.

This manual is also suitable for:

Emotion faros 180Emotion faros 360Emotion faros 90

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