Bittium Faros 180 Manuel utilisateur

www.bittium.com

Date of issue: September 30, 2019

800953 Version 2.0.0

Valid hardware revision: revH

Bittium Faros

Manual

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Table of Contents

1INTRODUCTION ........................................................................................................................................... 5

1.1 Contraindications .............................................................................................................................. 6

1.2 General safety precautions ............................................................................................................... 6

1.3 Warnings............................................................................................................................................ 7

1.4 Security .............................................................................................................................................. 7

1.5 Symbols.............................................................................................................................................. 8

1.6 Environmental conditions ................................................................................................................. 9

1.6.1 Transport and storage conditions ................................................................................................. 9

1.6.2 Continuous operating conditions .................................................................................................. 9

1.7 Bluetooth Protocol ............................................................................................................................ 9

2FAROS ECG SENSOR OVERVIEW................................................................................................................ 10

2.1 General information ........................................................................................................................ 10

2.2 Sensor symbols and indicators ........................................................................................................ 11

2.3 Accessories and replacement parts................................................................................................. 13

2.4 Recharging the battery .................................................................................................................... 14

2.5 Connection to Computer................................................................................................................. 15

2.5.1 Make the connection from Faros to computer ........................................................................... 15

2.5.2 Disconnect Faros from computer safely...................................................................................... 15

2.5.2.1 Using “Safely Remove Hardware and Eject Media” tool from Windows................................ 15

2.5.2.2 Using tool from Faros Manager............................................................................................... 16

2.6 Troubleshooting .............................................................................................................................. 17

3SOFTWARE INSTALLATION ........................................................................................................................ 18

4MEASUREMENT CONFIGURATION ............................................................................................................ 19

4.1 Holter measurement configuration................................................................................................. 20

4.2 Cardiac Event Recorder configuration............................................................................................. 21

4.3 User customized profiles ................................................................................................................. 22

4.4 Online mode .................................................................................................................................... 23

4.5 Settings ............................................................................................................................................ 24

4.6 About ............................................................................................................................................... 25

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5HOW TO START NEW RECORDING ............................................................................................................ 26

5.1 Patient preparation ......................................................................................................................... 26

5.1.1 Electrode positioning and lead placement.................................................................................. 27

5.1.2 Positioning of the FastFix electrode ............................................................................................ 27

5.2 Accelerometer data......................................................................................................................... 28

6DATA REVIEW WITH EDF VIEWER ............................................................................................................. 29

6.1 Measurement data review .............................................................................................................. 29

6.1.1 Review ......................................................................................................................................... 30

6.1.2 Accelerometer data ..................................................................................................................... 31

6.2 eMotion EDF Viewer menus............................................................................................................ 33

7MAINTENANCE AND SERVICE.................................................................................................................... 34

7.1 Tools view in Bittium Faros Manager software............................................................................... 34

7.1.1 Save measurement files .............................................................................................................. 34

7.1.2 Sensor firmware update.............................................................................................................. 36

7.1.3 Convert EDF file to Suunto SDF or ASCII file format.................................................................... 39

7.1.4 Change language ......................................................................................................................... 40

7.1.5 Support Request .......................................................................................................................... 40

7.2 Cleaning ........................................................................................................................................... 41

7.2.1 Faros sensor and Cable sets ........................................................................................................ 41

7.3 Sensor battery replacement............................................................................................................ 42

8FREQUENTLY ASKED QUESTIONS (FAQ) .................................................................................................... 43

What shall I do if I am experiencing difficulties with my Faros device?........................................................ 43

How I can review recorded cardiac events?.................................................................................................. 43

How do I know that the battery of the device is fully charged? ................................................................... 43

In my last measurement the time and date of the measurement were totally wrong. Why is that? How can

I fix this problem?.......................................................................................................................................... 43

Do I need software for downloading measurement data from the sensor? ................................................ 43

How can I reset my Faros device? ................................................................................................................. 43

How can I change the measurement modes of the device? ......................................................................... 44

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

Data Format)?................................................................................................................................................ 44

Firmware update is not working properly, or device is not responsive after failed firmware update? ....... 44

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What might be the reason for bad quality measurement data? .................................................................. 44

What is the suitable sampling frequency when measuring ECG?................................................................. 44

My Faros Sensor does not start, what might cause this problem?............................................................... 44

Why does Windows show a message indicating that device disk has errors and it should be scanned? .... 45

How long time Faros sensor is designed for operation?............................................................................... 45

9REGULATORY INFORMATION .................................................................................................................... 46

9.1 Classification EU .............................................................................................................................. 46

9.1.1 Declaration of Conformity ........................................................................................................... 46

9.2 Intended Use ................................................................................................................................... 47

Appendix 1. Electromagnetic Emission........................................................................................................ 48

Appendix 2. IMMUNITY TEST LEVELS .......................................................................................................... 49

MANUFACTURER ............................................................................................................................................. 51

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1INTRODUCTION

The Faros Sensor is a wearable, portable, externally applied electrocardiograph (ECG) recorder and wireless

transmitter for ECG measurement, 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. The data recorded by the device can be extracted by either a USB connection or via a

Bluetooth connection to a wireless device.

The device comes together with two bundled software; eMotion EDF Viewer for ECG data viewing and

Faros Manager software for changing the device settings and updating the device firmware. Detailed

analysis can be executed with Cardiac Explorer software or Cardiac Navigator Holter analysis software, both

available from Bittium. We also offer a Bluetooth API for third party connectivity and data extraction.

There are several different options for sensor attachment to human body. ECG and RR can be measured by

using Faros Sensor with FastFix electrode or cable set and commercially available single-use snap on ECG

electrodes.

Faros is intended for adult and pediatric patients who require vital sign monitoring be it inside or outside

hospital, or healthcare facility environment.

Faros does not provide interpretive statements. Final interpretation and diagnosis is the responsibility of a

physician.

Before operating Faros, please read this manual thoroughly and keep it for future reference.

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1.1 Contraindications

 Faros is contraindicated for those patients requiring attended, in-hospital monitoring for life

threatening arrhythmias.

1.2 General safety precautions

 Use ECG sampling rate of 500Hz with pediatric patients weighting less than 10 kg.

 Faros Sensor IP Classification code is 67.

 Do not disassemble, try to repair, or modify sensor.

 Sensor does not have any electrical stimulation capabilities.

 Faros does not directly provide diagnosis as a supervising physician is responsible for ECG data

interpretation.

 Accelerometer data is not analyzed within the device or differentiated between various physical

activities.

 Operating environments: Professional healthcare facility environment and Home healthcare

environment.

 If a patient has been given defibrillation, while Faros ECG sensor and applied part are connected to

the patient, Faros sensor and applied part must be sent to manufacturer for checking before

continuing device use.

 Always follow instructions for disposable electrodes which are used for recordings



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1.3 Warnings

 Sensor is not suitable for direct cardiac application.

 Do not attempt self-diagnosis or self-treatment based on acquired data.

 Not suitable for use in MRI environment.

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

equipment or with a defibrillator.

 Patients who have active implantable medical device (like heart pacemaker and so on), should

consult supervising physician or doctor before use.

 Do not touch parts of the computer, docking station or any non-medical electrical equipment and

the patient at the same time when operating the Faros ECG Sensor.

 To avoid danger of electrical shock and electromagnetic disturbances, the computer and associated

equipment used with the 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 in the patient environment, the

computer and peripherals must be plugged in using an isolation transformer that fulfils the

requirements.

 EMC disturbances might cause interference and/or noise to data acquisition

 Use Faros ECG sensor with accessories provided by Bittium Biosignals Ltd. Other cables and

accessories may negatively affect sensor performance.

 Portable RF communications equipment (including peripherals such as antenna cables and external

antennas) should be used no closer than 30 cm (12 inches) to any part of the Faros sensor,

including cables specified by Bittium Biosignals Ltd. Otherwise, degradation of the performance of

this equipment could result.

1.4 Security

System applications are recommended to be used with computers with proper anti-virus protection in-

stalled. Use of firewall is also recommended. Faros Bluetooth module uses Secure Simple Pairing (SSP).

Online measurements via Bluetooth connection with Faros device is recommended to be done in hidden

mode.

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1.5 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.

Consult Instruction for use

The Lot number of the electrodes.

For EU only: This symbol indicates

that this device shall be disposed

according to European Union

directive 2002/96/EC on Waste

Electrical and Electronic

Equipment (WEEE).

During transportation: keep

package dry, protect from rain.

NOTE!

Note text in manual: These

statements identify conditions or

practices that could result in

equipment performance loss or

must be otherwise observed.

Symbol

Description

IP67

IP classification for device. Faros

device is waterproof while recording

is made with cable set fixed to

device or with Fast-fix electrode

fixed to device.

This equipment contains specified

radio equipment that has been

certified to the Technical Regulation

Conformity Certification under the

Radio Law.

Bluetooth module BT121 is certified

in Japan with certification number

209-J00171

Wireless Transmission Symbol.

A relative humidity range of 15 % to

90 %, non-condensing

Transport and storage conditions

-20 °C to + 60 °C (transport)

-20 °C to + 60 °C at a relative

humidity up to 90 %, non-

condensing (storage)

Indicates the catalogue number so

that the medical device can be

identified

Manufacturer

Warning: MR-unsafe! Do not expose

the device to a magnetic resonance

(MR) environment

A data matrix (GS1) code is a two-

dimensional barcode consisting GTIN

and PI for Faros ECG sensor

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1.6 Environmental conditions

1.6.1 Transport and storage conditions

Faros shall be transported and storage in conditions listed below.

 -20 °C to + 60 °C (transport)

 - 20 °C to + 60 °C at a relative humidity up to 90 %, non-condensing (storage)

o 1 month storage: -20 °C to +60 °C

o 3 month storage: -20 °C to +45 °C

o 12 month storage: -20 °C to +25 °C

 Occasional storage and transport: -40°C to+70°C

1.6.2 Continuous operating conditions

Faros shall be used in conditions listed below:

 A temperature range of + 0 °C to + 45 °C

 A relative humidity range of 15 % to 90 %, non-condensing

 An atmospheric pressure range of 700 hPa to 1 060 hPa.

1.7 Bluetooth Protocol

Bittium Biosignals Ltd. will provide “Faros 3.x Bluetooth Protocol”documentation to support Faros ECG

sensor Bluetooth communication integration to 3rd party solutions.

3rd party interoperability requirements

Bluetooth 2.1

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2FAROS ECG SENSOR OVERVIEW

2.1 General information

There are two models of the Faros sensor; a 1-channel ECG model (Faros 180) and a 3-channel ECG model

(Faros 360). Both models are capable of Bluetooth communication; have the same form and shape but are

differentiated only by the color of the sensor and features.

Bittium Faros 180TM

Bittium Faros 360TM

901158

901159

Technical specification

Bittium Faros 180TM

Bittium Faros 360TM

ECG holter

Yes

ECG wireless transfer

Yes

Waterproof IP67 design

Yes

1-channel ECG

Yes

3-channel ECG

Yes

RR intervals

Yes

Bluetooth

Yes

Accelerometer

Yes

RR sampling frequency

1000 Hz

ECG sampling frequency

125, 250,

500, 1000 Hz

125, 250,

500, 1000 Hz

ADC precision

24 bits

3D accelerometer precision

14 bits

3D accelerometer sampling

frequency

25, 100 Hz

Datalogger file format

EDF

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