Related Manuals for Bittium Faros 180
Summary of Contents for Bittium Faros 180
- Page 1 Bittium Faros Manual Date of issue: September 30, 2019 © Bittium Biosignals Ltd Pioneerinkatu 6 FI-70800 Kuopio Finland 800953 Version 2.0.0 www.bittium.com Valid hardware revision: revH...
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Page 2: Table Of Contents
4 MEASUREMENT CONFIGURATION ......................19 Holter measurement configuration ....................20 Cardiac Event Recorder configuration ..................... 21 User customized profiles ......................... 22 Online mode ............................ 23 Settings ............................24 About ............................... 25 800953 Bittium Faros Manual 2 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... - Page 3 Review ............................30 6.1.2 Accelerometer data ........................31 eMotion EDF Viewer menus ......................33 7 MAINTENANCE AND SERVICE ........................34 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...
- Page 4 Classification EU ..........................46 9.1.1 Declaration of Conformity ......................46 Intended Use ........................... 47 Appendix 1. Electromagnetic Emission ......................48 Appendix 2. IMMUNITY TEST LEVELS ......................49 MANUFACTURER ............................. 51 800953 Bittium Faros Manual 4 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019...
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Page 5: Introduction
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. -
Page 6: Contraindications
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 800953 Bittium Faros Manual 6 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 7: Warnings
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. -
Page 8: Symbols
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 800953 Bittium Faros Manual 8 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 9: Environmental Conditions
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... -
Page 10: Faros Ecg Sensor Overview
2 FAROS 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. -
Page 11: Sensor Symbols And Indicators
ECG 125 Hz *Faros power source Li-ion battery complies with IEC 62133. Bittium Biosignals Ltd reserves all rights to improve, change and modify the products and the contents of the User Manual without prior notice. 2.2 Sensor symbols and indicators Sensor symbols and indicators provide information of the sensor state. - Page 12 *Green heart indicator changes color from green to blue in the following cases: 1) Measurement is running and Bluetooth is connected. 2) Sensor is in Bluetooth idle state and Bluetooth is connected. 800953 Bittium Faros Manual 12 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019...
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Page 13: Accessories And Replacement Parts
2.3 Accessories and replacement parts 2-electrodes cable set - 901021 3-electrodes cable set - 901022 5-electrodes cable set - 901023 Fast-Fix ECG Electrode - 901155 USB Cable - 900826 800953 Bittium Faros Manual 13 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 14: Recharging The Battery
Sensor’s battery is fully charged. Recommended recharge time is 1.5 hours. 4. Unplug the USB cable from the Faros Sensor and the computer Figure 2 Connecting Faros to computer using USB cable 800953 Bittium Faros Manual 14 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 15: Connection To Computer
“Eject FAROS” 4. Choose “Eject FAROS” and wait until Faros device has only blue light indicator turning on, then user can disconnect the device now. 800953 Bittium Faros Manual 15 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 16: Using Tool From Faros Manager
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 16 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 17: Troubleshooting
Charging dock’s battery might be empty. Connect the Faros sensor to PC or USB power adapter. Charging dock’s battery charges about 15 minutes before Sensor recharging starts if dock’s battery is completely empty. 800953 Bittium Faros Manual 17 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 18: Software Installation
After installation is complete click “Close”. Application shortcut icons appear on desktop. Applications are ready to use. *NOTE! Faros Manager icon also contain the current software version number. 800953 Bittium Faros Manual 18 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 19: Measurement Configuration
500, 1000 3.6.x 125, 250, 25, 100 2, 4, 16 500, 1000 Sensor Bluetooth Autostart Ambient Cardiac Pacemaker Lead off Configurable type temperature events events detection measurement time 800953 Bittium Faros Manual 19 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 20: Holter Measurement Configuration
Holter measurements can be performed with every Faros model. The configuration for Holter measure- ment is set using Faros Manager. Figure 3 Holter configuration 1. Run Bittium Faros Manager. 6. Select values for acquisition parameter: 2. Select ‘Holter’ mode from Manager main a. -
Page 21: Cardiac Event Recorder Configuration
Pause; Offset beats 4, Pause duration (seconds) 3 Bradycardia; Onset / Offset beats 8, Onset / Offset bpm 50 Tachycardia; Onset / Offset beats 16, Onset / Offset bpm 140 Atrial fibrillation; activated 800953 Bittium Faros Manual 21 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 22: User Customized Profiles
By choosing “My Profiles” in Measurement Profiles list, user can find a list of their saved customized pro- files on the top right column. Figure 7 User's profile list 800953 Bittium Faros Manual 22 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 23: Online Mode
4.4 Online mode The online ECG data monitoring is available on Faros 180 and Faros 360 Sensors. Configuration for online mode is set using the Faros Manager. 1. Run Bittium Faros Manager. 2. Select ‘Online Mode’ from Manager main view. -
Page 24: Settings
Measurement duration in minutes. Accelerometer based patient activity monitor, On/Off. Lead-off Detection, On/Off. Pacemaker Event Record, On/Off. Stop measurement by USB, On/Off. Figure 10 Settings view 800953 Bittium Faros Manual 24 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 25: About
4.6 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 11 About view... -
Page 26: How To Start New Recording
8. If necessary, the cables can be attached to the skin by tape. Notice that the tape should not touch the electrode. Step 4. Start the measurement: 9. Press the Sensor pushbutton once. 10. Green light indicator starts to blink – the Sensor is now recording. 800953 Bittium Faros Manual 26 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 27: Electrode Positioning And Lead Placement
If this positioning is not possible for some reason, the electrode can be placed horizontally above the chest muscles, with the USB connector pointing to right. Sternum position Horizontal position 800953 Bittium Faros Manual 27 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 28: Accelerometer Data
Accelerometer data when the subject does not move. The accelerometer output is raw data. Accelerometer data is not analyzed within the device or differentiated between various physical activities. Figure 12 Accelerometer axis directions 800953 Bittium Faros Manual 28 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 29: 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 Sensor it will take several minutes to open. 800953 Bittium Faros Manual 29 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 30: Review
Figure 13 EDF Viewer data view Gain mm/mV Speed mm/s ¼ 5 mm/mV 10 mm/s default 10 mm/mV Default 25 mm/s 20 mm/mV 50 mm/s 40 mm/mV 800953 Bittium Faros Manual 30 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 31: Accelerometer Data
(for example lying down) can be seen in figures 11 and 12. Figure 14 Accelerometer data with physical activity Figure 15 Accelerometer data without physical activity User interface parts 800953 Bittium Faros Manual 31 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... - Page 32 ‘Select/Clear all’ will toggle event selection between ‘None selected’ and ‘All selected’. ‘Event report’ will open a PDF report in a separate window with options to print or save. 800953 Bittium Faros Manual 32 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019...
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Page 33: 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 33 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 34: Maintenance And Service
Do not try to repair or modify the sensor. If you cannot solve a problem with the device, please contact medical.support@bittium.com for support. 7.1 Tools view in Bittium Faros Manager software 7.1.1 Save measurement files Measurement files can be saved from the Tools view by selecting ‘Save measurement files’. - Page 35 Figure 18 User can choose whether to delete saved measurement files on device SD card If you need to open the file save folder click ‘Open Save Location’. 800953 Bittium Faros Manual 35 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019...
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Page 36: Sensor Firmware Update
Manual update Follow these steps in case the firmware update must be performed manually: 1. Click ’Tools’ at the top of the main view. 2. Select ’Update firmware’. 800953 Bittium Faros Manual 36 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... - Page 37 4. Select the file and click ‘Open’. Firmware update will start. In case the update fails for some reason Faros Manager opens a view in which the Faros Sensor hardware revision must be selected. 800953 Bittium Faros Manual 37 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019...
- Page 38 2. Press and hold the Pushbutton on the Faros Sensor for 10-12 seconds. 3. Faros Manager will search for the Sensor and open the update view again. 800953 Bittium Faros Manual 38 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019...
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Page 39: Convert Edf File To Suunto Sdf Or Ascii File Format
If you want to view the save location of the converted file, click ‘Open Output Folder’. NOTE! Files including just raw ECG data (no R-R, no ACC) cannot be converted to SDF/ASC. Figure 23 Convert EDF file 800953 Bittium Faros Manual 39 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 40: Change Language
Figure 22. In this option, you can describe the issues of the device by typing after the line “Please describe your issue here”. Also, it is recommended that you attach the LOG file of the device to the email. 800953 Bittium Faros Manual 40 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 41: Cleaning
The Faros Sensor 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- 800953 Bittium Faros Manual 41 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 42: Sensor Battery Replacement
7.3 Sensor battery replacement Faros sensor battery is in-built part of sensor and can be changed only by Bittium Biosignals Ltd. Battery life time is depending on sensor usage modes and recharging cycles. It is recommended to replace battery after 300 cycles and in normal use scenarios this is in about 2,5 –... -
Page 43: Frequently Asked Questions (Faq)
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 at 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 to a computer with micro-USB cable. -
Page 44: How Can I Change The Measurement Modes Of The Device
If the two reasons presented above have not caused the problem, you can try to reset the device. If resetting the device does not help, please contact medical.support@bittium.com for assistance. What is the suitable sampling frequency when measuring ECG? This depends significantly on the purpose of use for the device. -
Page 45: Why Does Windows Show A Message Indicating That Device Disk Has Errors And It Should Be Scanned
Device life time is much depending on device use. Estimated device life time is 5 years. For cable sets recommendation is to change to new ones if there are seen damages on cables or on connectors. 800953 Bittium Faros Manual 45 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 46: Regulatory Information
According to the manufacturer of the Bluetooth modules: The Bluetooth modules meet the requirements of the EMC Directive 89/336/EEC as amended by Directives 92/31/EEC and 93/68/EEC within CE marking requirement. 800953 Bittium Faros Manual 46 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 47: 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 is intended for adult and pediatric patients who require vital sign monitoring inside or outside hospital or healthcare facility environment. -
Page 48: Appendix 1. Electromagnetic Emission
The Faros uses RF energy exclusively for its internal function. Thus the RF emission is very low and it is CISPR11 unlikely that nearby electronic devices would be disturbed. RF emissions Class B CISPR11 800953 Bittium Faros Manual 48 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... -
Page 49: 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 49 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019... - Page 50 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 50 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019...
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Page 51: Manufacturer
MANUFACTURER Bittium Biosignals Ltd Phone +358 (0)17 581 7700 Mail bbs@bittium.com Pioneerinkatu 6 Fax +358 (0)17 580 0978 www.bittium.com 70800 Kuopio Support requests via email Finland medical.support@bittium.com 800953 Bittium Faros Manual 51 (52) Version 2.0.0 © Bittium Biosignals Ltd 2019...
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