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Related Manuals for Neuroelectrics Enobio 20
Summary of Contents for Neuroelectrics Enobio 20
- Page 1 Neuroelectrics User Manual Enobio...
- Page 2 Avinguda Tibidabo, 47 bis 08035 Barcelona, Spain Tel. +34 93 254 03 66 Fax. +34 93 212 64 45 US Office 210 Broadway, Suite 201 Cambridge, MA 02139, USA Tel. +1 617 682 0770 Email: info@neuroelectrics.com www.neuroelectrics.com Copyright© by Neuroelectrics®. All rights reserved.
- Page 3 Manufacturer: Brand: Neuroelectrics Barcelona SLU Enobio Avinguda Tibidabo 47, bis 08035 Barcelona, Spain Telephone: + 34 93 254 03 70 Models: Enobio 8 Code: UM003E Enobio 20 Version: 2.4 Enobio 32 Date: 2018.12.10 The manufacturer should be contacted: - for assistance, if needed, in setting up, using or maintaining the Enobio system;...
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Page 4: About The Enobio User Manual
Manual does not discard the need of reading the Electrode and NIC parts. The Neuroelectrics User Manual includes three parts: The PDF version of all parts of the Neuroelectrics User Part I: Enobio User Manual Manual can be found under the Documentation section of... -
Page 5: Change Of Record
Change of Record Issue Date Changes made 2012.02.14 First version Neuroelectrics User Manual divided into three parts: 2016.02.18 (1) Enobio / Starstim, (2) Electrode and (3) NIC. 2017.03.10 SGS Update 2017.07.25 Product content update 2017.08.07 CE 0120 & symbols update 2018.16.07... -
Page 6: Table Of Contents
About the Enobio User Manual .........4 IV.1 Technical Specifications ........17 Change of Record .............5 IV.2 Contents of the Enobio Package ......18 IV.3 Necbox: Neuroelectrics Control Box ....24 Use of Enobio ..............7 IV.4 Assembling the Necbox and the electrode cables ..........26 I.1 Electroencephalography (EEG) ......8... -
Page 7: Use Of Enobio
Wireless operating system Flexible electrode placement Ease of use despite of the Ideal for out-of-the-lab applications with 39 possible positions complexity of the technology Offline data storage possible based on the 10-10 system with microSD card Enobio 8 Enobio 20 Enobio 32... -
Page 8: Electroencephalography (Eeg)
Electroencephalography (EEG) Intended Use Electroencephalography is a non- electrodes. ENOBIO WF is an EEG portable invasive neuroimaging technique that monitoring device of 8, 20, 32 The EEG measurements are records the electrical activity of the channels intended for use in a clinical frequently analyzed with spectral brain. -
Page 9: Applications
Intended Use Applications This device is intended to be used by Brain Computer It may be used anywhere, by anyone, trained health-care personnel. It is Interface (BCI) and as often as necessary, to quickly restricted to sale by or on order of a and reliably, acquire medical data. -
Page 10: Conditions Of Use
This can be achieve by combining Enobio with the Neurosurfer - the The device must be stored inside the Neuroelectrics neurofeedback software box between uses, in the following tool. Neurosurfer integrates EEG data, environmental conditions: brain stimulation, and an immersive Temperature Range: -25 to +65 °C... -
Page 11: Quality And Regulatory Information
II. Quality and Regulatory Information... -
Page 12: Ii.1 Quality Management System
II.2 Quality Management Medical Device System Regulations Neuroelectrics is an ISO 13485 and Neuroelectrics Enobio is a class IIa ISO 9901 certified company. Thus, device according to the classification our medical devices are designed in the Council Directive 93/42/EEC for and manufactured following the medical devices. -
Page 13: Safety Information
III. Safety Information Enobio conforms to the following standards: EN 60601-1:2006/A1:2013 UNE-EN 60601-1-2:2008 UNE-EN 60601-2-26:2004 IEC 60601-1-11:2010 EN 980:2008 EN 1041:2008 EN ISO 14971:2012 IEC 60601-1-6:2010... -
Page 14: Iii.1 Safety Warnings
III.1 Safety Warnings The result of the recordings must In the case of malfunction, placed on the subject’s scalp. be analyzed by a doctor or a immediately contact the The device must be used only with specialist. No self medication should manufacturer or the distributor. - Page 15 Some of these RF emitters (e.g. connected to the patient, the user RFID) may not be visible and The result of the recordings is should contact Neuroelectrics to the device can potentially be not displayed in legal units or check the correct simultaneous use.
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Page 16: The Enobio System
NIC User Manual. The NIC User Manual explains the steps picture and a short description of its function are listed. needed to correctly perform an EEG monitoring session. Lastly, the Neuroelectrics Control Box (Necbox) which is the core and the control unit of Enobio is described. -
Page 17: Iv.1 Technical Specifications
IV.1 Technical Specifications EEG functionality Battery operating time: Neuroelectrics Instrument Controller (NIC) software running on a computer. The EEG Number of channels: 8, 20 or 32 data is streamed through the Wi-Fi band, Channels Sampling rate: 500 SPS which has an operating distance range of 10 Bandwidth: 0 to 125 meters or less. -
Page 18: Iv.2 Contents Of The Enobio Package
IV.2 Contents of the Enobio Package The Enobio package contains all the components required to cables vary among the three models: Enobio 8 (EN8), Enobio 20 perform an EEG monitoring session, and some additional items (EN20), and Enobio 32 (EN32). - Page 19 Name / Description Code Enobio Necbox (8ch/20ch/32ch) NE010/ NE010WF The Enobio Neuroelectrics Control Box (Necbox) is the core of the Enobio system. NE002 The Necbox is battery operated and it is wirelessly paired NE002WF with the computer using the NIC software.
- Page 20 The 10 electrode cable contains 8 channels, numbered from 1 to 8, for EEG monitoring, and two reference channels labelled with CMS & DRL. It is included with Enobio 8, Enobio 20 and Enobio 32. It allows the channels to be freely assigned to any position of the headcap.
- Page 21 Item Name / Description Code 12 Electrode Cable EN32 NE018c This cable is included only with Enobio 32, and it is used together with NE018a and NEO18b. Its 12 cable connections are labelled with the positions: PO3, AF3, FC5, FC1, CP5, CP1, CP2, CP6, AF4, FC2, FC6, PO4 Neoprene Headcap M (54cm) NE019-M The Neoprene Cap is a comfortable solution to precisely place the electrodes on...
- Page 22 Item Name / Description Code Earclip NE027 The Earclip is an easy-to-use alternative to the sticktrode. It is a dual reference electrode because it is used to connect the two reference channels, CMS and DRL, to the same earlobe. The application of electrode gel is highly recommended. Read the Electrode User Manual before using the earclip.
- Page 23 In order to make your Enobio experience more complete, you can add accessories to your kit. In our catalog and on our website, you can find: Different sizes of the neoprene headcap: XL, L, M, S, Kids (K) and Kids Small (KS) The neoprene punch tool: Customize your own neoprene cap! Mouse Headcap Cover:...
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Page 24: Iv.3 Necbox: Neuroelectrics Control Box
IV.3 Necbox: Neuroelectrics Control Box The Necbox is the core and the control unit of Enobio. The Necbox is a battery operated device. It weighs 85 g and its dimensions are 87 mm x 61 mm x 24.8 mm. The following diagrams describe the details of the Necbox. - Page 25 NEUROELECTRICS BARCELONA AV. Tibidabo 47 bis 08035 Barcelona Spain MAC: Input: 5 W, 4.8 - 5.5V IP21 enobio enobio 8 Pin connector slots MicroSD card slot Velcro Technical Specifications labels The number of slots Slot for microSD card (Card To attach the Necbox to the...
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Page 26: Iv.4 Assembling The Necbox And The Electrode Cables
NE018c is added and connected to the orange slot. Enobio 20 and Enobio 32 may be alternatively used as an Enobio 8. In this case, the cable NE017 is the only cable that should be used, and it must be ... -
Page 27: Iv.5 Necbox Battery
IV.5 Necbox battery The battery can only be charged when Overdischarging may cause Electrical Specifications for charging: the device is at the OFF position. The loss of cell performance and/ battery charger connects to the Necbox. or damage to battery function. Voltage nominal input: 5 V DC The battery charger connects to the Expected life cycle:... -
Page 28: Iv.6 Cleaning Instructions Of The Enobio Kit
IV.6 Cleaning Instructions of the Enobio Kit Necbox & Electrode Cable Neoprene Headcap Electrodes The Enobio Necbox should be cleaned The Neoprene Headcap should be The cleaning instructions for the using a dry paper towel after each use. cleaned and disinfected as it follows: electrodes can be found in the Electrodes User Manual. -
Page 29: Symbols Used
V. Symbols Used Symbol Description Symbol Description Refer to the manual/booklet ISO 7000-2620 Transport and storage humidity conditions General warning sign ISO 7000-2621 Transport and storage IEC 60417-5010 Push ON/OFF button UNE-EN 60601-1=2008 atmospheric pressure conditions ISO 7000-2498 Serial Number according to UNE-EN 980 Transport package shall be kept away from rain and in dry condition. -
Page 30: Error Messages
VI. Error Messages The following messages might appear during normal operation: Error message Cause Actions Connection lost The computer cannot communicate Check that the device is switched on, that with the device. the device has battery, that the computer is communicating properly, and the device is close to the computer. -
Page 31: Electromagnetic Compatibility (Emc) Information
VII. Electromagnetic Compatibility (EMC) Information... - Page 32 For Professional Use The Enobio is suitable for use in the specified electromagnetic environment. The customer and/or user of the Enobio should ensure that is used in an electromagnetic environment as described below: Emissions Electromagnetic Test Compliance Environment Guidance RF Emissions Group 1 The Enobio uses RF energy only for its internal function.
- Page 33 The Enobio image intensifier is suitable for use in the specified electromagnetic environment. The customer and/or the user of Enobio image intensifier should ensure that it is used in an electromagnetic environment as described below: Immunity IEC 60601-1-2 Compliance Test Test Level Level Electrostatic discharge (ESD)
- Page 34 The Enobio is suitable for use in the specified electromagnetic environment. The customer and/or the user of Enobio should ensure that it is used in an electromagnetic environment as described below: Immunity IEC 60601-1-2 Compliance Test Test Level Level Conducted RF 3 Vrms 3 Vrms UNE-EN 61000-4-6:2014...
- Page 35 The Enobio is intended to be used in a controlled radiated RF environment. The user of the Enobio can help to prevent electromagnetic interferences keeping a minimum distance between the portable RF device (transmitter) and the Enobio as recommended below, according to the maximum output power of the communications device. For transmitters rated at a maximum output power not listed NOTE: These guidelines may not apply in all situations.
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