Neuroelectrics Enobio 20 User manual

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Neuroelectrics User Manual
Enobio

Europe Ofce
Avinguda Tibidabo, 47 bis
08035 Barcelona, Spain
Tel. [phone]
Fax. [phone]
US Ofce
210 Broadway, Suite 201
Cambridge, MA 02139, USA
Tel. [phone]
Email: [email protected]
www.neuroelectrics.com
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Copyright© by Neuroelectrics®. All rights reserved.

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Manufacturer:
Neuroelectrics Barcelona SLU
Avinguda Tibidabo 47, bis
08035 Barcelona, Spain
Telephone: + 34 93 254 03 70
Code: UM003E
Version: 2.4
Date: 2018.12.10
Brand:
Enobio
Models:
Enobio 8
Enobio 20
Enobio 32
The manufacturer should be contacted:
- for assistance, if needed, in setting up, using or maintaining the Enobio system;
- to report an unexpected operation of events that result from the usage of the device.
Input: 5W, 4.25 - 7 V

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About the Enobio User Manual
The Enobio User Manual belongs to Part I of the
Neuroelectrics User Manual.
The Neuroelectrics User Manual includes three parts:
uPart I: Enobio User Manual
uPart II: Electrode User Manual
uPart III: NIC User Manual
Before your rst use of the Enobio system, read the three
parts of the Neuroelectrics User Manual. The Enobio User
Manual does not discard the need of reading the Electrode
and NIC parts.
The PDF version of all parts of the Neuroelectrics User
Manual can be found under the Documentation section of
Neuroelectrics webpage:
www.neuroelectrics.com/documentation/

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Issue Date Changes made
1.0 2012.02.14 First version
2.0 2016.02.18 Neuroelectrics User Manual divided into three parts:
(1) Enobio / Starstim, (2) Electrode and (3) NIC.
2.1 2 017. 03 .10 SGS Update
2.2 2 017. 07. 2 5 Product content update
2.3 2017.08.07 CE 0120 & symbols update
2.4 2018.16.07 Product content & safety symbols update
Change of Record

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About the Enobio User Manual .........................................4
Change of Record .............................................................5
I. Use of Enobio ..............................................................7
I.1 Electroencephalography (EEG) ..............................8
I.2 Intended Use ..........................................................8
I.3 Applications ............................................................9
I.4 Conditions of Use .................................................10
II. Quality and Regulatory Information ..........................11
II.1 Quality Management System ..............................12
II.2 Medical Device Regulations ................................12
III. Safety Information .....................................................13
III.1 Safety Warnings .................................................14
IV. The Enobio System ...................................................16
IV.1 Technical Specications .....................................17
IV.2 Contents of the Enobio Package ........................18
IV.3 Necbox: Neuroelectrics Control Box ..................24
IV.4 Assembling the Necbox
and the electrode cables ............................................26
IV.5 Necbox battery ...................................................27
IV.6 Cleaning Instructions of the Enobio Kit ..............28
V. Symbols Used ...........................................................29
VI. Error Messages .........................................................30
VII.Electromagnetic Compatibility
(EMC) Information .....................................................31
Table of Contents

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I. Use of Enobio
Enobio 32Enobio 8 Enobio 20
Enobio is a modern EEG device:
Enobio is a wireless and portable electrophysiology sensor system for the
recording of the electrical activity of the human brain.
uAvailable with 8, 20 or 32 channels
uWireless operating system
uIdeal for out-of-the-lab applications
uOffline data storage possible
with microSD card
uComfortable and precise headcap,
with different head sizes available
uFlexible electrode placement
with 39 possible positions
based on the 10-10 system
uCapable of monitoring
EOG, ECG and EMG
uEase of use despite of the
complexity of the technology

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I.1
Electroencephalography (EEG)
I.2
Intended Use
Electroencephalography is a non-
invasive neuroimaging technique that
records the electrical activity of the
brain. Voltage uctuations, that result
from the ionic current within the brain
neurons, are detected by electrodes
placed on the scalp. The 10-20
international system denes 21 scalp
positions to place the EEG electrodes.
Additionally, the 10-10 system is
obtained by adding electrodes in
the intermediate positions. Both
locations and nomenclature of
the electrodes are standardized
by the International Federation of
Clincial Neurophysiology. The EEG
measurements can be either bipolar
or unipolar. The former method
measures the potential difference
between pairs of electrodes, while
the latter measures the electrode
potential compared to a reference. The
reference might be either the signal
from one electrode or the average of
the measurement from two or more
electrodes.
The EEG measurements are
frequently analyzed with spectral
methods to dene frequency bands,
also known as brain waves. The ve
most common bands are delta (0 - 4
Hz), theta (4 - 8 Hz), alpha (8 - 13 Hz),
beta (13 - 30 Hz), and gamma (30 - 50
Hz). These waveforms provide crucial
information regarding brain function
which is widely use to diagnose
Epilepsy, sleep disorders, Coma
or cerebral death. The EEG differs
from other neuroimaging techniques
due to its high temporal resolution.
However, it is often combined with
magnetic resonance imaging (MRI)
or computed tomography (CT) for
the diagnosis of tumors, stroke and
other brain disorders whose diagnose
also requires high-spatial resolution.
EEG is also used for event-related
potentials (ERP’s) studies, which
analyze the EEG response to visual,
ENOBIO WF is an EEG portable
monitoring device of 8, 20, 32
channels intended for use in a clinical
environment, hospital, research center
or home healthcare environment. The
applications considered are medical
and non-medical such as: Brain
to computer interface (BCI), Basic
EEG research, Medical applications
developments, neuromodulation,
biometry and user affective state.
ENOBIO use must be controlled by
specialized medical personnel able to
guarantee the correct recording.
It is intended to acquire, store, transmit
and display electrophysiological
signals in wireless mode as an aid
in diagnostics. The system digitizes
analogue EEG signals collected by a
cap with electrodes, amplies them,
and uses Wi-Fi wireless connectivity to
transmit the EEG data to a dedicated
host computer with the software.

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I.3
Applications
This device is intended to be used by
trained health-care personnel. It is
restricted to sale by or on order of a
physician.
Brain Computer
Interface (BCI)
In order to build real world BCI
applications, it is essential that
the subject be comfortable and
behaving naturally in his typical
environment. Enobio was designed
with these constraints in mind, thus
it may be used as a platform for the
development of BCI applications
away from the lab. Possible BCI
paradigms include Motor Imagery
ERD, SSVEP and P300 among others.
Currently, Enobio is being used by
many researchers and it is compatible
with BCI software systems such as
BCI2000, OpenVibe, PureData and
Processing.
Medical application
development
Enobio is the ideal platform for
when large amounts of data need to
be collected from several subjects
in natural environments in order to
develop medical applications.
It may be used anywhere, by anyone,
and as often as necessary, to quickly
and reliably, acquire medical data.
Data integrity, versatility and ease of
use are the keys to the development
of medical applications. NIC software
and the Nube Cloud Service provide
the means to achieve them efciently.
Clinical applications include sleep
monitoring and Epilepsy.
Basic electrophysiological
research
Enobio offers an advantage in any
scenario in which electrophysiological
data is difcult to obtain in a natural
way. Spontaneous EEG or ERP’s on
the go are possible with Enobio due to
the absence of long wires.
I.2
Intended Use

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Neuromodulation
EEG neuromodulation is the process
of modifying brain state via feedback-
based training. By visualizing the brain
activity, the user can learn to modify
it. Recent work provides evidence for
the use of neuromodulatory therapy in
the treatment of a variety of disorders.
This can be achieve by combining
Enobio with the Neurosurfer - the
Neuroelectrics neurofeedback software
tool. Neurosurfer integrates EEG data,
brain stimulation, and an immersive
virtual reality game, all into one
platform.
User affective state
User emotional state can be derived
from physiological signals like EEG
and ECG. Enobio provides a platform
for research and development in
affective computing and smart
systems.
Biometry
Enobio can be used as a physiological
biometry platform to authenticate users
based on EEG and ECG signatures.
Physiological biometric techniques
are naturally robust against spoong
attacks and can provide user state
information while authentication takes
place.
Enobio must be used with normal
temperature, humidity and pressure
conditions:
uTemperature Range: +5 to 45 °C
uHumidity: 15 - 93 %
uAtmospheric Pressure:
700 - 1.000 hPa
The device must be stored inside the
box between uses, in the following
environmental conditions:
uTemperature Range: -25 to +65 °C
uHumidity: 15 - 93 %
This equipment needs to be installed
and put into service in accordance to
the information provided in this user
manual.
I.3
Applications
I.4
Conditions of Use

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II. Quality
and Regulatory
Information

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Neuroelectrics is an ISO 13485 and
ISO 9901 certied company. Thus,
our medical devices are designed
and manufactured following the
corresponding ISO quality
management systems.
Neuroelectrics complies with Quality
System Regulation 21 CFR 820.
Neuroelectrics Enobio is a class IIa
device according to the classication
in the Council Directive 93/42/EEC for
medical devices.
Enobio conforms to the following
Standards and Directives:
USA
Clearance by the FDA, regulation
510(k) (K162681)
Europe
Directive 93/42/EEC for medical
devices
Canada
Canadian Medical Device Regulations
SOR/98-282
II.1
Quality Management
System
II.2
Medical Device
Regulations

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III. Safety Information
Enobio conforms to the following standards:
uEN 60601-1:2006/A1:2013
uUNE-EN 60601-1-2:2008
uUNE-EN 60601-2-26:2004
uIEC 60601-1-11:2010
uEN 980:2008
uEN 1041:2008
uEN ISO 14971:2012
uIEC 60601-1-6:2010

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WThe result of the recordings must
be analyzed by a doctor or a
specialist. No self medication should
be done based on the results.
WThe device must never be
opened or damaged.
WThe battery can only be replaced
by authorized personnel.
WBefore using, please check that
the device is not damaged and
the packaging has not been
affected by transport or storage.
WBefore using the device, please
inform the prescribing clinician or
operator of the presence of any
pacemakers, intracranial electrodes,
implanted debrillators, cranial
pathologies (e.g. holes, plaques),
implantable neurostimulators, deep
brain stimulators, or any other
prosthesis´. In these cases, the use
of the device could become unsafe.
WIn the case of malfunction,
immediately contact the
manufacturer or the distributor.
WThe device is not protected
against excessive moisture or
immersion in liquid. In the case of
the device becoming wet or damp,
do not use it and immediately
contact the manufacturer.
WDo not touch the device while
EEG monitoring is on.
WAlways unplug the USB power
supply from the device prior to
connecting electrodes to the
subject. The device will not work
when the battery is charging.
WNever use the device or install
the electrodes on the head of
the patient while connected
to the power network.
WDo not switch the device on or
off when it is assembled and
placed on the subject’s scalp.
WThe device must be used only with
Ag/AgCl electrodes recommended
by the manufacturer.
WThe device is not protected against
other high frequency devices. To
avoid risks place the CMS/DRL as
far as possible from the electrodes
of the high frequency device.
WThe device is wireless and can be
affected by other RF devices.
WThe device needs special EMC
precautions. It needs to be used
according to the EMC information
at the end of the user manual.
WThe EMC emissions and immunity
have been tested using the
10-wire and 12-wire 34 cm cables
provided with the system.
WThe device can only be used on
healthy skin without wounds.
III.1
Safety Warnings

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WThe use of cables or electrodes
other than the ones delivered
with the product might produce
higher EMC emissions and
less EMC immunity.
WThe device cannot be
used in the MRI room.
WThe device is not provided sterile
and should not be sterilized.
WThe device does not need
installation, maintenance
or calibration.
WThe device and the
accessories should be regularly
checked by the user.
WIf the user wants to use the device
in combination with another device
connected to the patient, the user
should contact Neuroelectrics to
check the correct simultaneous use.
WThe modication of the
device is not allowed.
WIf the device has not been used
during a long period of time, the
user should check visually that
there is no battery leakage.
WThe device cannot be used beside
or put under other equipment.
If such usage is needed, check
the normal conguration.
WThe electrodes and wires or any
conductive part cannot touch any
other conductive part of any other
device including the ground.
WThe cap is intended to be on the
patient for less than 24 hours.
WEnobio should not be used in an
MRI room or close to CT, diathermy,
RFID and electromagnetic security
systems such as metal detectors.
Some of these RF emitters (e.g.
RFID) may not be visible and
the device can potentially be
exposed to elds from these
RF emitters without the user’s
awareness. If any electromagnetic
interference is encountered,
the user will be informed by the
software with the “Packet Loss”
alarm, and will indicate the user
to stop the recording and move
to a place without interference.
In any case, the electromagnetic
interference does not involve any
risks to the patient, as Enobio is
a non-invasive recording device
that does not modify or interact
with the person’s brain.
WKeep out of reach from children
and anyone else who might
swallow electrodes,or cause
injury to themselves.
WKeep out of reach from children
and anyone else who might
strangle themselves with the
cables of the devices.
WThe result of the recordings is
not displayed in legal units or
other units within the meaning of
Directive 80/181/ECC. Therefore
the device is not considered to
have a measuring function.

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IV. The Enobio
System
This chapter describes the Enobio system. First, it lists the
technical specications of Enobio. Then, the components
included in the Enobio package are listed and described.
For each item, the product code, the product name, a
picture and a short description of its function are listed.
Lastly, the Neuroelectrics Control Box (Necbox) which is
the core and the control unit of Enobio is described.
For further information regarding the use of the electrodes,
please consult the Electrode User Manual. Additionally, to
learn how to pair your device with the computer, read the
NIC User Manual. The NIC User Manual explains the steps
needed to correctly perform an EEG monitoring session.

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EEG functionality
uNumber of channels: 8, 20 or 32
uSampling rate: 500 SPS
uBandwidth: 0 to 125
Hz (DC coupled)
uResolution: 24 bits - 0.05 µV
uMeasurement noise: < 1 µV RMS
Other Technical Specications
uAccelerometer: 3-axis
uCommunication:
Wi.Fi or USB (Only available for use
with USB Isolator accessory cable)
uOutput: EDF+ (16 bits), ASCII data
files or TCP/IP raw data streaming
uOS compatibility: Windows (Vista
/ 7 / 8 /10) and MAC OS X Snow
Leopard
uBattery operating time:
All
Channels
EEG
Wi-Fi Enobio 32 5 h 15 min
Enobio 20 5 h 20 min
Enobio 8 6 h 23 min
USB Enobio 32 19 h 0 min
Enobio 20 19 h 0 min
Enobio 8 23 h 35 min
*SD card recording will increase these values slightly
Minimum Computer Requirements
uOperating System: Windows Vista
or MAC OS X Snow Leopard
uProcessor: 1.6 GHz
uRAM: 2 GB
uWi-Fi, or USB
Wireless Information
Enobio is a wireless device. The
Necbox connects through Wi-Fi to the
Neuroelectrics Instrument Controller (NIC)
software running on a computer. The EEG
data is streamed through the Wi-Fi band,
which has an operating distance range of 10
meters or less.
IV.1
Technical Specifications

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The Enobio package contains all the components required to
perform an EEG monitoring session, and some additional items
that may be useful during your experiments. In the following
pages, you may nd a description for each item. Please note that
the necbox code, the number of electrodes, and the electrode
cables vary among the three models: Enobio 8 (EN8), Enobio 20
(EN20), and Enobio 32 (EN32).
IV.2
Contents of the Enobio Package
Quantity Code Name
1
NE010/ NE010WF
NE002/ NE002WF
NE009/ NE 009WF
Enobio 8/20/32 Necbox
1NE013/NE055 USB Power Adapter
1
NE013a
NE013b
NE013c
EU / US / UK
Power Supply Plug
1NE014 Curved Syringe
1NE015 USB Stick with Manuals & NIC
1NE016a Electrode Gel 250cl
1NE017 10 Electrode Cable
0 / 1 / 1 NE018a 10 Electrode Cable EN 20/EN32
0 / 1 / 1 NE018b 12 Electrode Cable EN20/EN32
0 / 0 / 1 NE018c 12 Electrode Cable EN32
Quantity Code Name
1NE019-M Neoprene Headcap M (54cm)
8 / 25 / 40 NE022 Electrode: Geltrode
50 / 50 / 50 NE025 Electrode: Sticktrode
1NE027 Electrode: Earclip
1NE172 USB Extension Cable
1NE031b USB Wi-Fi Dongle

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Item Name / Description Code
Enobio Necbox (8ch/20ch/32ch)
uThe Enobio Neuroelectrics Control Box (Necbox) is the core of the Enobio system.
uThe Necbox is battery operated and it is wirelessly paired
with the computer using the NIC software.
uThe Necbox battery should never be charged during a stimulation session or an EEG recording.
NE010/
NE010WF
NE002
NE002WF
NE009
NE009WF
USB Power Adapter & Power Supply Plug
uThe USB power adapter is used to charge the Necbox battery.
uThe type of the power supply plug (EU/US/UK) included in
the kit depends on the country of the customer.
NE013/
NE055
NE013a
NE013b
NE013c
Curved Syringe
uThe curved syringe is used to inject electrode gel in the electrodes.
uWash and clean it after each use.
NE014
USB Stick with Manuals & NIC SW
uThe USB stick contains the PDF version of the three parts of the
Neuroelectrics User Manual, and the NIC software.
uBoth items can be also found at www.neuroelectrics.com.
NE015

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Item Name / Description Code
Electrode Gel 250 cl
uThe electrode gel is a highly conductive and water soluble gel. It must be
applied on the contact surface, between the electrode and the scalp, in
order to decrease the impedance and improve the signal quality.
NE016a
10 Electrode Cable
uThe 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.
NE017
10 Electrode Cable EN20/EN32
uThis cable is included with Enobio 20 and Enobio 32, and is used together with NE018b.
uIts 10 cable connections are labelled with the positions:
uP7, P4, Cz, Pz, P3, P8, O1, O2, CMS & DRL
NE018a
12 Electrode Cable EN20/EN32
uThis cable is included with Enobio 20 and Enobio 32, and is used together with NE018a.
uIts 12 cable connections are labelled with the positions:
uF7, T7, Fp1, F3, C3, Fz, Fp2, F4, C4, F8, T8, and EXT (EN20) or Oz (EN32).
NE018b