Related Manuals for Bittium Faros
Summary of Contents for Bittium Faros
- Page 1 [Function/Subject] [Document type] Bittium Faros™ Manual Date of issue: Sep 12, 2023 © Bittium Biosignals Ltd Pioneerinkatu 6 FI-70800 Kuopio Finland 800953 Version 7.0.0 www.bittium.com...
- Page 2 Bittium Biosignals Ltd shall not be liable for errors contained herein or for damages in connection with the furnishing, performance, or use of this material.
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Page 3: Table Of Contents
4.5.2 Disconnect Faros from computer safely ..................25 Bittium SafePort ..........................27 4.6.1 Connecting to computer with the Bittium SafePort ..............28 4.6.2 Recharging the battery with the Bittium SafePort ..............29 Troubleshooting ..........................29 5 SOFTWARE INSTALLATION ........................30 6 MEASUREMENT CONFIGURATION ...................... - Page 4 OmegaSnap adapter ........................59 Device battery replacement ......................59 FREQUENTLY ASKED QUESTIONS (FAQ) ..................60 What can I do if I am experiencing difficulties with my Faros device? ............60 How can I review recorded cardiac events? ....................60 800953 Bittium Faros Manual 4 (80) Version 7.0.0...
- Page 5 What is the suitable sampling frequency when measuring ECG? ..............61 My Faros device does not start, what might cause this problem? ............... 61 Why does Windows show a message indicating that device disk has errors, and it should be scanned? ... 62 How long is the Faros device lifetime? ......................
- Page 6 Technical specifications and performance ....................72 Appendix 4. Bittium Faros 180L supplementary information ..............75 General Warnings, Cautions and safety precautions ..................75 Declaration of Conformity ..........................78 Manufacturer ..............................79 800953 Bittium Faros Manual 6 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023...
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Page 7: Conventions
Table 1 Terms used in the document Term Description ECG or EKG Electrocardiogram European Data Format Ingress Protection Secure Simple Pairing Medical Device Directive Medical Device Regulation 800953 Bittium Faros Manual 7 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023... -
Page 8: General Warnings And Cautions To Review Before Use
2 GENERAL WARNINGS AND CAUTIONS TO REVIEW BEFORE USE Do not operate Bittium Faros™ device without first reviewing the following notices. See also Appendix 3: Bittium OmegaSnap electrodes supplementary information and Appendix 4: Bittium Faros 180L supplemen- tary information. WARNING: Do not disassemble, try to repair, or modify device. - Page 9 Use ECG sampling rate of 500Hz with pediatric patients weighing less than 10 kg. CAUTION: If a patient has been given defibrillation, while Faros ECG device and applied part are connected to the patient, Faros device and applied part must be sent to manufacturer for checking before continuing device use. CAUTION: Faros device is not suitable to use in MRI environment.
- Page 10 NOTE Always follow instructions for disposable electrodes which are used for recordings 800953 Bittium Faros Manual 10 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023...
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Page 11: Introduction
3 INTRODUCTION The information in this user guide applies to Bittium Faros device revision H or later. The goal of this user guide is to provide an understanding of using Bittium Faros device. CAUTION: Failing to follow the operation instructions in this manual may result in improper analysis of the data. -
Page 12: Contraindications
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. Hidden mode can be configured using Faros Manager. With any concern related to security please contact medical.support@bittium.com... -
Page 13: Symbols
Note text in manual: These statements identify conditions or practices that could result in equipment performance loss or must be otherwise observed. Medical device. Faros device is IP67. This equipment contains specified radio equipment that has been certified to the Technical Regulation Conformity Certification under the Radio Law. - Page 14 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 of GTIN and PI for Faros ECG device. Atmospheric pressure limitation. Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
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Page 15: Environmental Conditions
An atmospheric pressure range of 700 hPa to 1 060 hPa. 3.5 Bluetooth Protocol Bittium Biosignals Ltd. will provide “Faros 3.x Bluetooth Protocol” documentation to support Faros ECG device Bluetooth communication integration to 3rd party solutions. Table 2 Bluetooth Protocol 3rd party interoperability requirements Bluetooth 2.1... -
Page 16: Warranty
All warranties will be invalidated if unauthorized repairs are made to any parts of the overall system. The liability of Bittium Biosignals Ltd is limited to the repair of the product under warranty and specifically excludes consequential loss. The warranty covers all labor and parts associated with normal use. The warranty does not cover travelling expenses in case the repair is needed at end-user’s facilities. -
Page 17: Disposal
Waste Electrical and Electronic Equipment (WEEE). If the device is contaminated the directive may not apply. The equipment may contain confidential information. Follow national standards and guidelines regarding secure disposal of waste containing confidential information. 800953 Bittium Faros Manual 17 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023... -
Page 18: Faros Ecg Device Overview
4 FAROS ECG DEVICE OVERVIEW 4.1 General information There are three models of the Faros device: a 1-channel ECG models (Faros 180 and Faros 180L) and a 3- channel ECG model (Faros 360). All models are capable of Bluetooth communication; have the same form and shape but are differentiated only by the color and device features. -
Page 19: Device Symbols And Indicators
ECG 125 Hz ECG 250 Hz ECG 125 Hz *Faros power source Li-ion battery complies with IEC 62133. 4.2 Device symbols and indicators Device symbols and indicators provide information of the device state. Device has four LEDs and a buzzer for audio indications. - Page 20 *Green heart indicator changes colour from green to blue in the following cases: • Measurement is running and Bluetooth is connected. • Device is in Bluetooth idle state and Bluetooth is connected. 800953 Bittium Faros Manual 20 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023...
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Page 21: Accessories And Replacement Parts
9404644 Bittium OmegaSnap 1-CH ECG Electrode (Applied part) 9404716 Bittium OmegaSnap 2-CH ECG Electrode (Applied part) NOTE OmegaSnap 2-CH ECG Elec- trode is supported from Faros device firmware version 3.7.2 and Faros Manager version 3.4.0 onwards. 800953 Bittium Faros Manual 21 (80) Version 7.0.0... - Page 22 9404717 Bittium OmegaSnap 3-CH ECG Electrode (Applied part) 9404718 Bittium MiniSnap Sensitive 1-CH ECG Electrode (Applied part) 9404719 Bittium OmegaSnap Multi-CH Adapter (Applied part) 800953 Bittium Faros Manual 22 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023...
- Page 23 9400147 Bittium OmegaSnap 1-CH Adapter (Applied part) 9404265 2-electrodes cable set (Applied part) 9404266 3-electrodes cable set (Applied part) 9404282 5-electrodes cable set (Applied part) 5501020 USB Cable 800953 Bittium Faros Manual 23 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023...
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Page 24: Recharging The Battery
1. Plug the USB cable to your computer. 2. Plug the other end of the USB cable to your Faros device. Blue light indicator starts to blink. Blue light indicator shines continuously when the device’s battery is fully charged. Recommended recharge time is 1.5 hours. -
Page 25: Connection To Computer
Use the USB cable delivered with your Faros device to connect the device to your personal computer. 1. Plug the USB cable to your computer. 2. Plug the other end to your Faros device. Blue light indicator starts to blink first, and then green light indicator should start to blink also. - Page 26 Faros de- vice was removed successfully or not. If Faros device could not be removed, please check if there are any measurement files still open on the computer or any program is using Faros device memory card. 800953 Bittium Faros Manual 26 (80) Version 7.0.0...
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Page 27: Bittium Safeport
4.6 Bittium SafePort Bittium SafePort is a USB cradle designed to facilitate the daily use of Bittium Faros devices and to protect them from electrical and mechanical failures (E.g., Rough handling of the device. Moisture residue in the connector of a recently cleaned device etc.). -
Page 28: Connecting To Computer With The Bittium Safeport
2. Plug the other end of USB cable to your SafePort USB cradle. Green light indicator in Bittium SafePort is lit. 3. Place the Faros ECG devices in the Bittium SafePort. Blue light indicator on Faros device starts to blink first, and then green light indicator should start to blink also. -
Page 29: Recharging The Battery With The Bittium Safeport
Bittium SafePort USB cradle, there may be a connection issue. In this case, you should first check that the Faros device is properly attached to Bittium SafePort USB cradle. If this is not the case, then disconnect the USB cable connection and reconnect again, also check carefully that the USB connection between the device and the cable and between the cable and your computer is not loose. -
Page 30: Software Installation
Use Windows 10 64-bit operating system for installing Faros Manager or EDF Viewer soft- ware. Connect Faros device to your computer via USB and browse to “FAROS_DATA/Software” folder. To install applications, run installer programs from “eMotion EDF Viewer” and “Faros Manager” folders. After this... - Page 31 Application shortcut icons appear on desktop. Applications are ready to use. NOTE Faros Manager icon contains also the current software version number. 800953 Bittium Faros Manual 31 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023...
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Page 32: Measurement Configuration
3. Configure desired settings. Click “Save” button to apply the configuration. Click “Close” to exit the application. Remove Faros device safely (see ch. 4.5.2) Faros Manager recognizes the model of the connected device, and the configuration options are based on the device model. The options are presented in tables below. -
Page 33: Holter Measurement Configuration
3 electrodes, OmegaSnap-2ch (supported from firmware version 3.7.2) 5 electrodes, OmegaSnap-3ch 6.1 Holter measurement configuration Holter measurements can be performed with every Faros model. The configuration for Holter measure- ment is set using Faros Manager. NOTE Faros 180L requires using Faros Manager version 3.4.1 or later. -
Page 34: Cardiac Event Recorder Configuration
6.2 Cardiac Event Recorder configuration Cardiac event recordings can be performed with every Faros model. The configuration for Cardiac Event Recorder mode is set using Faros Manager. 800953 Bittium Faros Manual 34 (80) Version 7.0.0... -
Page 35: User Customized Profiles
Tachycardia; Onset / Offset beats 16, Onset / Offset bpm 140 6.3 User customized profiles In Faros Manager 3.4.x, you can save your current measurement configurations to a profile for later use. Click on “Save as new profile” button at the bottom bar of application. -
Page 36: Online Mode
Figure 8 User profile 6.4 Online mode The online ECG data monitoring is available on Faros 180 and Faros 360 devices. Configuration for online mode is set using the Faros Manager. 1. Run Bittium Faros Manager. 2. Select ‘Online’ from Manager main view. - Page 37 4. Press ‘Save’ to apply configuration. 5. Click “Close”. Device is now ready to perform online ECG data monitoring. Contact Bittium to receive further information on using Faros device with a mobile device. Figure 9 Online configuration Advanced settings Select Advanced settings to open Faros Manager settings view.
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Page 38: Electrode Positions
6.5 Electrode positions The selection of Electrode positions affects the displayed device settings. Always set the image to match the type of electrode used for measurement to ensure the optimal measurement results. 800953 Bittium Faros Manual 38 (80) Version 7.0.0... -
Page 39: About
6.6 About About view describes the software version details as well as license information. You can also access the User Manual by clicking ’Read Manual’ and send a support request to Bittium Biosignals by clicking ’Support request’. Figure 12 About view... -
Page 40: Change Language
6.6.1 Change language You can change the language used in Faros Manager by selecting About and then clicking ‘Change lan- guage’. The available languages are Finnish, English, Swedish, Danish, German, and French. Once the lan- guage is selected clicking Close will set that language in use. -
Page 41: How To Start And Stop A Recording
• When the battery is full, the blue light indicator shines continuously. The Faros device has one pushbutton. The device starts when you push the button. 7.1 Patient preparation for OmegaSnap electrodes Step 1: Prepare the skin of the patient in the area where the electrode is placed: a) Shave the hair off from the area where the electrode is placed. -
Page 42: Positioning Of The Omegasnap Electrode
The recommended position for the MiniSnap electrode is on the middle of the sternum as seen in the pic- tures. Please refer to following User manual for more information on how to use MiniSnap Sensitive elec- trode: • 5800647 Bittium MiniSnap Sensitive 1-CH ECG Electrode Quick Guide 800953 Bittium Faros Manual 42 (80) Version 7.0.0... -
Page 43: Patient Preparation For Electrodes And Leads
Table 10 MiniSnap Sensitive 1-CH Electrode NOTE Bittium MiniSnap™ Sensitive 1-CH ECG electrode is the most suitable for 24h ECG measurements on small adults and children. NOTE Optimal signal quality is obtained when the electrode is fully placed on top of the thorax and the bottom of the electrode is clearly above the diaphragm. -
Page 44: Electrode Positioning And Lead Placement
If necessary, the cables can be attached to the skin with tape. Notice that the tape should not touch the electrode. Step 4. Start the measurement: Press the Faros device pushbutton once. Green light indicator starts to blink – the device is now recording. 7.2.1 Electrode positioning and lead placement The operator should be familiar with the correct placement of electrodes. -
Page 45: Accelerometer Data
The accelerometer output is raw data. Accelerometer data is not analyzed within the device or differentiated between various physical activities. Figure 13 Accelerometer axis directions 800953 Bittium Faros Manual 45 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023... -
Page 46: Data Review With Edf Viewer
NOTE It is recommended to move a large data file (<100 MB) to personal computer before reviewing the data. If you are opening large data files directly from Faros device, it will take several minutes to open. 800953 Bittium Faros Manual 46 (80) Version 7.0.0... -
Page 47: Review
Selected data appears on eMotion EDF Viewer. Data can be reviewed using the scrollbar or arrow keys or page up/down buttons on the keyboard. Figure 14 EDF Viewer data view 800953 Bittium Faros Manual 47 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023... -
Page 48: Accelerometer Data
40 mm/mV 8.1.2 Accelerometer data The physical activity output is raw data from the Faros device’s in-built accelerometer. The data recorded by the accelerometer is used to recognize movement (for example sports, walking or other physical activity) from the measurement. - Page 49 Table 13 User interface description User interface parts Data window shows the measured ECG data. Info window contains Faros device configuration which was used in the measurement. Manually created events are listed in the Event window. 800953 Bittium Faros Manual 49 (80) Version 7.0.0...
- Page 50 • End time: Recording end date and time formatted. • ID: ID tag set in Faros device. • Data view: EDF data view pointer, that is the date and time of current data in review window. Events window shows the manually created patient markers.
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Page 51: Emotion Edf Viewer Menus
(3D) can be reviewed if they are recorded. Before opening the .edf-file click ‘Tools’ and ‘View’ to select presented signal types. Help Help menu contains software-related information, link to manufacturer webpage and the User Manual. 800953 Bittium Faros Manual 51 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023... -
Page 52: Maintenance And Service
9 MAINTENANCE AND SERVICE Faros device does not require any maintenance procedures except recharging the battery. Please follow these simple precautions to ensure correct functioning: • Handle this device carefully • Store the device away from dusty or dirty areas •... - Page 53 2. Click ‘Save’ to save the files. Saved files will appear at the top of the view. Figure 18 Measurement files are saved After the files have been saved it is possible to delete them from Faros device: 800953 Bittium Faros Manual 53 (80) Version 7.0.0...
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Page 54: Device Firmware Update
Figure 19 Delete measurement files confirmation dialog 9.1.2 Device firmware update Automatic update Faros device firmware update is performed automatically if software detects that a newer firmware is available for the device. NOTE Latest firmware for Bittium Faros devices is also available for downloads via Bittium web- site: https://www.bittium.com/medical/support... - Page 55 Figure 20 Tools view 3. Select the location where the firmware file is with the ‘Browse’ button. Click the arrow icon if you want to cancel the operation. Note that you must disconnect the Faros device first before clicking this.
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Page 56: Convert Edf File To Suunto Sdf Or Ascii File Format
Faros device stops supporting measurement in SDF/ASC format from firmware version 3.2.x onwards. In- stead, Faros Manager provides users with a new tool called “Convert EDF to SDF/ASC” which helps in choosing and converting an EDF file to SDF file format (HRV signal) and ASC (ASCII format for accelerometer... -
Page 57: Support Request
9.1.4 Support Request If you encounter any issues or you would like to give us some feedback, you can easily send a support re- quest to us by using “Support Request” tool in “About”. 800953 Bittium Faros Manual 57 (80) Version 7.0.0... -
Page 58: Cleaning
9.2.1 Faros device, Bittium Safeport and cable sets The Faros device, Safeport and cable sets can be cleaned by wiping the device using a non-fluffing cloth dampened with cleaning fluid such as mild hand soap solution, or water. A non-fluffing cloth dampened with non-alcoholic disinfection fluid can be used for disinfection. -
Page 59: Omegasnap Adapter
9.3 Device battery replacement Faros device battery is an in-built part of the device and can be changed only by Bittium Biosignals Ltd. Bat- tery lifetime depends on device usage modes and recharging cycles. It is recommended to replace the bat- tery after 300 cycles and in normal use scenarios this is in about 2,5 –... -
Page 60: 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. Please remember to fully charge your Faros devices before the first use. -
Page 61: How Can I Change The Measurement Modes Of The Device
My Faros device does not start, what might cause this problem? It is important to remember that Faros device uses the energy of the battery also when it is on standby mode (“power off” mode). For example, the device’s inner clock uses the battery also when it is turned off to keep the time. -
Page 62: Why Does Windows Show A Message Indicating That Device Disk Has Errors, And It Should Be Scanned
Disk error may occur when the device is not disconnected safely from computer. Please follow instructions in section 4.5.2. How long is the Faros device lifetime? Device lifetime depends on device use. Estimated device lifetime is 5 years. For cable sets recommendation is to change to new ones if there is any damage on cables or on connectors. -
Page 63: Regulatory Information
Council Directive 93/42/EEC of 14 June 1993 (and the Finnish national laws 1505/94 and 1506/94) concerning medical devices. When used with external evaluation software this declaration of conformity is valid for the Faros hardware. Trade Name: Faros Product Family... -
Page 64: Intended Use
Bluetooth to companion systems for further analysis. These systems can be either third party systems or designed, maintained and/or owned by Bittium. Faros device is intended for adult and pediatric patients who require vital sign monitoring inside or outside hospital or healthcare facility environment. -
Page 65: Appendix 1. Electromagnetic Emission
Appendix 1. Electromagnetic emission Manufacturer's Declaration - Electromagnetic Emissions Faros device 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 66: Appendix 2. Immunity Test Levels
Voltage interruptions IEC 61000-4-11 Not applicable Surges IEC 61000-4-5 Not applicable Line-to-line Surges IEC 61000-4-5 Not applicable Line-to-ground Electrical fast transients / IEC 61000-4-4 Not applicable bursts 800953 Bittium Faros Manual 66 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023... - Page 67 2 400 – 2 Bluetooth, Pulse WLAN, modulation 802.11 b/g/n, 217 Hz RFID 2450, LTE Band 7 5240 5 100 – 5 WLAN 802.11 Pulse modulation 5500 217 Hz 5785 800953 Bittium Faros Manual 67 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023...
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Page 68: Appendix 3. Bittium Omegasnap Electrodes Supplementary Information
1 meter of water for 30 minutes. Both the Faros device and the OmegaSnap adapter can be used in shower when connected to each other. -
Page 69: Symbols
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 device, including cables specified by Bittium Biosignals Ltd. Otherwise, degradation of the performance of this equipment could result. -
Page 70: Contraindications
Omega ECG electrode is an electrocardiograph (ECG) electrode which is applied to the surface of the hu- man body to transmit the ECG signal at the body surface to an ambulatory ECG device. Bittium OmegaSnap electrode is intended for use with Bittium Faros device. -
Page 71: User Responsibility
Should any repair or replacement become necessary, we recommend that the device is delivered to your local distributor or Bittium Biosignals Ltd for service. The user of the product is solely responsible for any malfunction resulting from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Bittium Biosignals Ltd or their authorized service personnel. -
Page 72: Technical Specifications And Performance
Table 15 OmegaSnap 1-CH ECG Electrode specifications Technical specification Value Dimensions 170 x 54 mm, without liner Wear time 7 days IP classification IP67 (Faros device with OmegaSnap 1-CH Adapter) Biological properties Skin contact type Non-invasive Sterility Non-sterile Skin contact duration 7 days... - Page 73 Table 18 MiniSnap 1-CH ECG Electrode specifications Technical specification Value Dimensions 115 x 38 mm, without liner Wear time 24 hours IP classification IP67 (Faros device with OmegaSnap 1-CH Adapter) 800953 Bittium Faros Manual 73 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023...
- Page 74 Biological properties Skin contact type Non-invasive Sterility Non-sterile Skin contact duration 24 hours Clinical properties Purpose Ambulatory ECG Single use Recording standard Holter Recording type Continuous 800953 Bittium Faros Manual 74 (80) Version 7.0.0 © Bittium Biosignals Ltd 2023...
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Page 75: Appendix 4. Bittium Faros 180L Supplementary Information
Bittium Faros 180L is not suitable for direct cardiac application. WARNING: Do not touch parts of the computer, docking station or any non-medical electri- cal equipment and the patient at the same time when operating the Bittium Faros 180L device. WARNING:... - Page 76 CAUTION: Bittium Faros 180L device is not suitable to use in MRI environment. CAUTION: Bittium Faros 180L device is not intended to be used at the same time with high frequency (HF) surgical equipment or with defibrillator. CAUTION: Patients, who have active implantable medical device (like heart pacemaker etc.) should consult supervising physician or doctor before use.
- Page 77 Accelerometer data is not analyzed within the device or differentiated between various physical activities. NOTE Bittium Faros 180L device should be kept closer than 10 meters to the Bluetooth companion device for wireless communication. NOTE Faros ECG sensor housing materials are tested and comply with ISO 10993 biocompatibility requirements.
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Page 78: Declaration Of Conformity
Council Directive 93/42/EEC of 14 June 1993 (and the Finnish national laws 1505/94 and 1506/94) concerning medical devices. When used with external evaluation software this declaration of conformity is valid for the Faros hardware. Trade Name: Faros Product Family... -
Page 79: Manufacturer
MANUFACTURER Bittium Faros 180, Faros 180L and Faros 360 comply with the requirements of the Medical Device Directive 93/42/EEC and carry the CE 0537 mark accordingly. Bittium OmegaSnap comply with requirements of the Medical Device Regulation 2017/745 and carry the CE mark accordingly. - Page 80 Email: bbs@bittium.com Web: https://www.bittium.com WEBSITE You can find up-to-date product information, documents, and updates by visiting the Bittium website at www.bittium.com SALES Please contact your sales representative for any questions that you may have about Bittium products. Bittium Biosignals Ltd.
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