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Summary of Contents for Mega Electronics eMotion 90 FAROS
- Page 1 800778 eMotion Faros Series Manual 2.3.0 Copyright© 2017, Mega Electronics Ltd Date of issue: April 10, 2017 Mega Electronics Ltd, Pioneerinkatu 6, FI-70800 Kuopio, Finland, http://www.megaemg.com...
- Page 2 5.2. Accelerometer Data ..........................19 6. Data Review with eMotion EDF Viewer ..................20 6.1. Measurement Data Review ........................20 6.1.1. Review ............................21 6.1.2. Accelerometer Data ........................22 6.2. eMotion EDF Viewer Menus ....................... 24 Copyright© 2017, Mega Electronics Ltd...
- Page 3 9. Regulatory information ....................... 34 9.1. Classification EU ..........................34 9.1.1. Declaration of Conformity ......................34 9.1.2. Intended Use ..........................35 Appendix 1. Electromagnetic Emissions ..................36 Appendix 2. Electromagnetic Immunity ..................37 Manufacturer ........................... 39 Copyright© 2017, Mega Electronics Ltd...
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Page 4: Introduction
800778 eMotion Faros Series Manual 2.3.0 1. Introduction The eMotion Faros Sensor is a wearable, portable, externally applied electrocardiograph (ECG) recorder and wireless transmitter for ECG measurement, HRV (R-R interval) data measurement and patient motion capturing. The sensor monitors patient ECG and can be set to generate event markers using the built-in arrhythmia detection algorithms. -
Page 5: General Safety Precautions
800778 eMotion Faros Series Manual 2.3.0 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 eMotion Faros Series Manual 2.3.0 1.3. Symbols Symbol Description 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
ECG 125 Hz ECG 125 Hz *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. 4 / 39... -
Page 8: Accessories And Replacement Parts
800778 eMotion Faros Series Manual 2.3.0 2.2. Accessories and Replacement Parts Cable sets 2-electrodes 3-electrodes 5-electrodes 900865 900866 900867 Charging Dock and USB cable Charging dock USB Cable VP00516 900826 Stingray adapter and textile belt Textile belt Stingray Adapter 900810 900809 Fast Fix Electrode Fast Fix Electrode... -
Page 9: Sensor Symbols And Indicators
800778 eMotion Faros Series Manual 2.3.0 2.3. Sensor Symbols and Indicators Sensor Symbols and Indicators provide information of the sensor state. Sensor has four LEDs and Buzzer for audio indications. Indications are presented in tables below. Figure 2.4.1-1: Sensor symbols and indicators Description Indications Sensor is connected to computer... -
Page 10: Recharging The Battery
800778 eMotion Faros Series Manual 2.3.0 2.4. Recharging the Battery 2.4.1. Charging via USB It is recommended to recharge the battery to full capacity before conducting operations or performing data acquisition with the device NOTE! Make sure that the sensor is completely dry, especially the USB connector, before you start to recharge your Faros Sensor. -
Page 11: Charging With Charger Station
800778 eMotion Faros Series Manual 2.3.0 2.4.2. Charging with Charger Station Connect Charger Station to PC via USB Cable delivered with Charger Station. Cable is connected correctly when the 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 12: Software Installation
800778 eMotion Faros Series Manual 2.3.0 3. Software Installation Connect Faros sensor to your computer via USB and browse to “FAROS_DATA/Software” folder. To install applications run installer programs from “eMotion EDF Viewer” and “eMotion Faros Manager” folders. After this follow instructions on screen. Steps EDF Viewer Faros Manager... -
Page 13: Measurement Configuration
800778 eMotion Faros Series Manual 2.3.0 4. Measurement Configuration The measurement configuration is managed with eMotion Faros Manager software. Connect Sensor to computer and run Faros Manager software from desktop icon o Alternatively browse to “FAROS_DATA/Software” folder on device hard drive and run eMotion Faros Manager from there ... -
Page 14: Holter Measurement Configuration
800778 eMotion Faros Series Manual 2.3.0 4.1. Holter Measurement Configuration Holter measurements can be performed with every Faros model. The configuration for Holter measurement is set using Faros Manager. 1. Run eMotion Faros Manager 2. Select ‘Datalogger mode’ from Manager main view 3. -
Page 15: Advanced Settings
800778 eMotion Faros Series Manual 2.3.0 4.2. Advanced Settings The access to advanced settings is protected by a PIN code. The default PIN-code is 70800. Figure 2: Advanced settings PIN code Advanced Settings configures following features: Measurement duration (e.g. automatic stop after 24h) ... - Page 16 800778 eMotion Faros Series Manual 2.3.0 Advanced Setting appears on right side. Figure 3: Advanced settings view Advanced settings (default detection values)*** Pause; Offset beats 4, Pause duration (seconds) 3 Bradycardia; Onset / Offset beats 8, Onset / Offset bpm 50 Tachycardia;...
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Page 17: Online Mode
800778 eMotion Faros Series Manual 2.3.0 4.3. Online Mode The Online ECG Data monitoring is available on Faros 180 or Faros 360 sensors. Configuration for online mode is set using Faros Manager. 1. Run eMotion Faros Manager 2. Select ‘Online Mode’ from Manager main view 3. -
Page 18: Heart Rate Variability Measurement
800778 eMotion Faros Series Manual 2.3.0 4.4. Heart Rate Variability Measurement Heart Rate Variability data measurement can be performed with every Faros model. Configuration for HRV measurement is set using Faros Manager software. 1. Run eMotion Faros Manager 2. Select ‘Datalogger mode’ from Manager view 3. -
Page 19: How To Start New Recording
800778 eMotion Faros Series Manual 2.3.0 5. How to Start New Recording Before recording make sure that the battery of the sensor is fully charged. The sensor can be charged with the USB-cable included in the Faros package or with a regular micro-USB recharger. ... -
Page 20: Electrode Position And Lead Placement
800778 eMotion Faros Series Manual 2.3.0 5.1.1. Electrode Position and Lead Placement The operator should be familiar with correct placement of electrodes. Incorrectly placed electrodes will weaken the reliability of the data. Cable sets are compatible with 4 mm snap connector ECG Electrodes. 2-lead, 1-channel position 3-lead, 1-channel position 5-lead, 3-channel position... -
Page 21: Positioning Of The Fast-Fix Electrode
800778 eMotion Faros Series Manual 2.3.0 5.1.2. Positioning of the Fast-Fix electrode The recommended position for the FastFix electrode is on the left border of the sternum as seen in the left side of the picture. If this positioning is not possible for some reason, the electrode can be placed diagonally on the left side of the chest, seen in the picture on the right. -
Page 22: Accelerometer Data
800778 eMotion Faros Series Manual 2.3.0 5.2. Accelerometer Data The data recorded by the accelerometer can be utilized by the operator to recognize the movement and non-movement periods from the measurement. 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 23: Data Review With Emotion Edf Viewer
800778 eMotion Faros Series Manual 2.3.0 6. Data Review with eMotion EDF Viewer 6.1. Measurement Data Review Faros EDF data recordings can be reviewed using eMotion EDF Viewer. For installation instructions, see chapter 3. Open eMotion EDF Viewer from desktop icon or alternatively; 1. -
Page 24: Review
800778 eMotion Faros Series Manual 2.3.0 6.1.1. Review 1. Click ‘Open EDF’ in main view (Alternative select ‘File’ and ‘Open’) 2. Select a EDF record file a. Browse FAROS_DATA hard drive and open “DATA” folder b. Folder names indicate the date of performed measurement(s) c. -
Page 25: Accelerometer Data
800778 eMotion Faros Series Manual 2.3.0 6.1.2. 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 movement (e.g. sports, walking or other physical activity) from the measurement. - Page 26 800778 eMotion Faros Series Manual 2.3.0 User interface parts Data window presents the measured ECG data. Info window contains Faros sensor configuration which was used in measurement. Manually created events are listed in Event window. Info window presents configuration of acquisitioned ECG data.
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Page 27: Emotion Edf Viewer Menus
800778 eMotion Faros Series Manual 2.3.0 6.2. eMotion EDF Viewer Menus Menu options Tools, Options Event Report layout and parameters can be managed from ‘Tools’ ‘Option’ menu. Calibrate To calibrate ‘Data window’ mm-grid view select ‘Calibrate’ from ‘Tools’. Measure the blue rectangle and write the values below. -
Page 28: Maintenance And Service
800778 eMotion Faros Series Manual 2.3.0 7. 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 29 800778 eMotion Faros Series Manual 2.3.0 Device update process is illustrated by progress bar running from 0 % to 100 %. When device is updated at 100 % state, the software has to wait until it detects Faros connection and it may take 4-6 seconds for this step If the device is updated successfully, it will say that “Update process is successful.
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Page 30: Options View
800778 eMotion Faros Series Manual 2.3.0 7.2. Options View Actions to update sensor firmware The menu contains standard menu structure for manager view settings, tools and help. Tools menu contain items: Save measurement files Update firmware Change PIN code Convert EDF to SDF/ASC Change language Help menu contains items: Read manual... -
Page 31: Save Measurement Files
800778 eMotion Faros Series Manual 2.3.0 7.2.1. Save Measurement Files Actions to Save Measurement Files This section provides users with instruction to choose and save measurement files from eMotion Faros device to their PC in a convenient way by using eMotion Faros Manager. First, click on “Tools”... - Page 32 800778 eMotion Faros Series Manual 2.3.0 Copying process is presented file-by-file. If all measurement files are copied successfully, a message will be shown. You can click on “Open” button to open folder where files are saved. During the copying process, if the USB connection between eMotion Faros device and PC corrupts and measurement files cannot continue to copy, a message may appear.
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Page 33: Convert Edf File Format To Suunto Sdf File Or Ascii File Format
800778 eMotion Faros Series Manual 2.3.0 7.2.2. Convert EDF File Format to Suunto SDF file or ASCII File Format eMotion Faros device stops supporting measurement in SDF/ASC format from firmware version 3.2.x. Instead, eMotion Faros Manager provides users with a new tool “Convert EDF to SDF/ASC” which helps in choosing and converting EDF file to SDF file format (HRV signal) and ASC (ASCII format for accelerometer data). -
Page 34: Cleaning
800778 eMotion Faros Series Manual 2.3.0 7.3. Cleaning 7.3.1. eMotion Faros sensor, Stingray Adapter and Cable sets The eMotion Faros ECG Sensor, Stingray adapter and cable sets can be cleaned by wiping device using a non-fluffing cloth dampened in cleaning fluid, such as mild hand soap solution, or in water. For disinfection can be used non-fluffing cloth dampened non-alcoholic disinfection fluid. -
Page 35: Frequently Asked Questions (Faq)
800778 eMotion Faros Series Manual 2.3.0 8. Frequently asked questions (FAQ) How I can review recorded Cardiac Events? Cardiac Events recorded by Faros can be reviewed with software which needs to be purchased separately. To get quotation and more information, please contact us medical.support@bittium.com 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... -
Page 36: Firmware Update Is Not Working Properly
800778 eMotion Faros Series Manual 2.3.0 Firmware update is not working properly? If firmware update process is normally finished but firmware is not upgraded, try again using another USB-port on your computer. Alternatively create a folder named SYS on Faros Data hard drive. Copy firmware file to SYS-folder. -
Page 37: Regulatory Information
800778 eMotion Faros Series Manual 2.3.0 9. Regulatory information 9.1. Classification EU In accordance with MDD 93/42/EEC: Class IIa product EN60601-1: Internally powered equipment 9.1.1. 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: Intended Use
800778 eMotion Faros Series Manual 2.3.0 9.1.2. Intended Use The eMotion Faros is an ambulatory recorder and transmitter for ECG and motion (accelerometer) data. Faros can perform ECG measurement, R-R interval data measurement and capture patient motion. All data is recorded to sensor internal memory. eMotion Faros monitors patient ECG and generates event markers using the in-built arrhythmia detection algorithms. -
Page 39: Appendix 1. Electromagnetic Emissions
800778 eMotion Faros Series Manual 2.3.0 Appendix 1. Electromagnetic Emissions Manufacturer's Declaration - Electromagnetic Emissions The eMotion Faros is suitable for use in an electromagnetic environment as described below. The users should ensure that the device is used in such an environment. Emission Tests Compliance Electromagnetic Environment... -
Page 40: Appendix 2. Electromagnetic Immunity
800778 eMotion Faros Series Manual 2.3.0 Appendix 2. Electromagnetic Immunity Manufacturer’s Declaration – Electromagnetic Immunity The eMotion Faros is suitable for use in an electromagnetic environment as described below. The users should ensure that the device is used in such an environment. Electromagnetic Interference Resistance IEC 60601- Testing... - Page 41 800778 eMotion Faros Series Manual 2.3.0 Manufacturer's Declaration - Electromagnetic Interference Resistance The eMotion Faros is suitable for use in an electromagnetic environment as described below. The users should ensure that the device is used in such an environment. Interference IEC 60601-Testing Accordance Electromagnetic Environment - Guidelines...
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Page 42: Manufacturer
800778 eMotion Faros Series Manual 2.3.0 Manufacturer Mega Electronics Ltd Phone +358 (0)17 581 7700 Mail mega@megaemg.com Pioneerinkatu 6 Fax +358 (0)17 580 0978 Website www.megaemg.com 70800 Kuopio Finland 39 / 39...
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