Bittium Faros - Page 74

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800953 Bittium Faros Manual

74 (80)

Version 7.0.0

Biological properties

Skin contact type

Non-invasive

Sterility

Non-sterile

Skin contact duration

24 hours

Clinical properties

Purpose

Ambulatory ECG

Single use

Yes

Recording standard

Holter

Recording type

Continuous

Main Page

Table of Contents3
Conventions7
Terminology7
General Warnings and Cautions to Review before Use8
Introduction11
Contraindications12
Security12
Symbols13
Environmental Conditions15
Transport and Storage Conditions15
Continuous Operating Conditions15
Bluetooth Protocol15
Warranty16
Disposal17
Faros Ecg Device Overview18
General Information18
Device Symbols and Indicators19
Accessories and Replacement Parts21
Recharging the Battery24
Connection to Computer25
Connecting Faros to a Computer25
Disconnect Faros from Computer Safely25
Bittium Safeport27
Connecting to Computer with the Bittium Safeport28
Recharging the Battery with the Bittium Safeport29
Troubleshooting29
Software Installation30
Measurement Configuration32
Holter Measurement Configuration33
Cardiac Event Recorder Configuration34
User Customized Profiles35
Online Mode36
Electrode Positions38
About39
Change Language40
How to Start and Stop a Recording41
Patient Preparation for Omegasnap Electrodes41
Positioning of the Omegasnap Electrode42
Positioning of the Minisnap Electrode42
Patient Preparation for Electrodes and Leads43
Electrode Positioning and Lead Placement44
Stopping a Recording44
Accelerometer Data45
Data Review with Edf Viewer46
Measurement Data Review46
Review47
Accelerometer Data48
Emotion EDF Viewer Menus51
Maintenance and Service52
Tools View in Bittium Faros Manager Software52
Save Measurement Files52
Device Firmware Update54
Convert EDF File to Suunto SDF or ASCII File Format56
Support Request57
Cleaning58
Faros Device, Bittium Safeport and Cable Sets58
Omegasnap Adapter59
Device Battery Replacement59
Frequently Asked Questions (Faq)60
What Can I Do if I am Experiencing Difficulties with My Faros Device60
How Can I Review Recorded Cardiac Events60
How Do I Know that the Battery of the Device Is Fully Charged60
In My Last Measurement the Time and Date of the Measurement Were Totally Wrong. Why Is That? How Can I Fix this Problem60
Do I Need Software for Downloading Measurement Data from the Device60
How Can I Reset My Faros Device60
How Can I Change the Measurement Modes of the Device61
Which Data Format Should I Choose for My Measurement, SDF (Suunto Data Format) or EDF (European Data Format)61
Firmware Update Is Not Working Properly, or Device Is Not Responsive after Failed Firmware Update61
What Might be the Reason for Bad Quality Measurement Data61
What Is the Suitable Sampling Frequency When Measuring ECG61
My Faros Device Does Not Start, What Might Cause this Problem61
Why Does Windows Show a Message Indicating that Device Disk Has Errors, and It Should be Scanned62
How Long Is the Faros Device Lifetime62
Regulatory Information63
Classification EU63
Declaration of Conformity63
Intended Use64
Appendix 1. Electromagnetic Emission65
Appendix 2. Immunity Test Levels66
Appendix 3. Bittium Omegasnap Electrodes Supplementary Information68
General Warnings, Cautions and Safety Precautions68
Symbols69
Contraindications70
Adverse Events70
Intended Use70
Classification EU70
User Responsibility71
Environmental Conditions71
Transport and Storage Conditions71
Continuous Operating Conditions71
Technical Specifications and Performance72
Appendix 4. Bittium Faros 180L Supplementary Information75
General Warnings, Cautions and Safety Precautions75
Declaration of Conformity78
Manufacturer79

Bittium Faros - Page 74

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