1
Neuroelectrics User Manual
Enobio
Europe Ofce
Avinguda Tibidabo, 47 bis
08035 Barcelona, Spain
Tel. +34 93 254 03 66
Fax. +34 93 212 64 45
US Ofce
210 Broadway, Suite 201
Cambridge, MA 02139, USA
Tel. +1 617 682 0770
Email: info@neuroelectrics.com
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:
u Part I: Enobio User Manual
u Part II: Electrode User Manual
u Part 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/
5
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. 03.1 0 SGS Update
2.2 2017. 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
6
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 Specications .....................................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 C ompatibility
(EMC) Information .....................................................31
Table of Contents
7
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.
u Available with 8, 20 or 32 channels
u Wireless operating system
u Ideal for out-of-the-lab applications
u Offline data storage possible
with microSD card
u Comfortable and precise headcap,
with different head sizes available
u Flexible electrode placement
with 39 possible positions
based on the 10-10 system
u Capable of monitoring
EOG, ECG and EMG
u Ease of use despite of the
complexity of the technology
8
I.1
Electroencephalography (EEG)
I.2
Intended Use
Electroencephalography is a noninvasive 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 denes 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 dene 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, amplies them,
and uses Wi-Fi wireless connectivity to
transmit the EEG data to a dedicated
host computer with the software.
9
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 efciently.
Clinical applications include sleep
monitoring and Epilepsy.
Basic electrophysiological
research
Enobio offers an advantage in any
scenario in which electrophysiological
data is difcult 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
10
Neuromodulation
EEG neuromodulation is the process
of modifying brain state via feedbackbased 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. Neurosur fer 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 spoong
attacks and can provide user state
information while authentication takes
place.
Enobio must be used with normal
temperature, humidity and pressure
conditions:
u Temperature Range: +5 to 45 °C
u Humidity: 15 - 93 %
u Atmospheric Pressure:
700 - 1.000 hPa
The device must be stored inside the
box between uses, in the following
environmental conditions:
u Temperature Range: -25 to +65 °C
u Humidity: 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
11
II. Quality
and Regulatory
Information
12
Neuroelectrics is an ISO 13485 and
ISO 9901 certied 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 classication
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
13
III. Safety Information
Enobio conforms to the following standards:
u EN 60601-1:2006/A1:2 013
u UNE- EN 60601-1-2:2008
u UNE-EN 60601-2-26:2004
u IEC 60601-1-11:2010
u EN 980:2008
u EN 1041:20 0 8
u EN ISO 14971:2012
u IEC 60601-1-6:2010
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W The result of the recordings must
be analyzed by a doctor or a
specialist. No self medication should
be done based on the results.
W The device must never be
opened or damaged.
W The battery can only be replaced
by authorized personnel.
W Before using, please check that
the device is not damaged and
the packaging has not been
affected by transport or storage.
W Before using the device, please
inform the prescribing clinician or
operator of the presence of any
pacemakers, intracranial electrodes,
implanted debrillators, 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.
W In the case of malfunction,
immediately contact the
manufacturer or the distributor.
W The 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.
W Do not touch the device while
EEG monitoring is on.
W Always 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.
W Never use the device or install
the electrodes on the head of
the patient while connected
to the power network.
W Do not switch the device on or
off when it is assembled and
placed on the subject’s scalp.
W The device must be used only with
Ag/AgCl electrodes recommended
by the manufacturer.
W The 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.
W The device is wireless and can be
affected by other RF devices.
W The device needs special EMC
precautions. It needs to be used
according to the EMC information
at the end of the user manual.
W The EMC emissions and immunity
have been tested using the
10-wire and 12-wire 34 cm cables
provided with the system.
W The device can only be used on
healthy skin without wounds.
III.1
Safety Warnings
15
W The use of cables or electrodes
other than the ones delivered
with the product might produce
higher EMC emissions and
less EMC immunity.
W The device cannot be
used in the MRI room.
W The device is not provided sterile
and should not be sterilized.
W The device does not need
installation, maintenance
or calibration.
W The device and the
accessories should be regularly
checked by the user.
W If 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.
W The modication of the
device is not allowed.
W If the device has not been used
during a long period of time, the
user should check visually that
there is no battery leakage.
W The device cannot be used beside
or put under other equipment.
If such usage is needed, check
the normal conguration.
W The electrodes and wires or any
conductive part cannot touch any
other conductive part of any other
device including the ground.
W The cap is intended to be on the
patient for less than 24 hours.
W Enobio 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.
W Keep out of reach from children
and anyone else who might
swallow electrodes,or cause
injury to themselves.
W Keep out of reach from children
and anyone else who might
strangle themselves with the
cables of the devices.
W The 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 specications 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.
17
EEG functionality
u Number of channels: 8, 20 or 32
u Sampling rate: 500 SPS
u Bandwidth: 0 to 125
Hz (DC coupled)
u Resolution: 24 bits - 0.05 µV
u Measurement noise: < 1 µV RMS
Other Technical Specications
u Accelerometer: 3-axis
u Communication:
Wi.Fi or USB (Only available for use
with USB Isolator accessory cable)
u Output: EDF+ (16 bits), ASCII data
files or TCP/IP raw data streaming
u OS compatibility: Windows (Vista
/ 7 / 8 /10) and MAC OS X Snow
Leopard
u Battery 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 car d reco rding will increase th ese valu es slig htly
Minimum Computer Requirements
u Operating System: Windows Vista
or MAC OS X Snow Leopard
u Processor: 1.6 GHz
u RAM: 2 GB
u Wi-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
18
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/ N E010W F
NE002/ NE002WF
NE00 9/ NE 009WF
Enobio 8/20/32 Necbox
1 NE013/NE055 USB Power Adapter
1
NE013 a
NE013 b
NE013 c
EU / US / UK
Power Supply Plug
1 NE014 Curved Syringe
1 NE015 USB Stick with M anuals & N IC
1 NE016a Electrode Gel 250cl
1 NE017 10 Electrode Cable
0 / 1 / 1 NE018a 10 Electrode Cable EN 20 /EN32
0 / 1 / 1 NE018 b 12 Electrode Cable EN20/EN32
0 / 0 / 1 NE018c 12 Electrode Cable EN32
Quantity Code Name
1 NE019 -M Neopren e Headc ap M (54 cm)
8 / 25 / 40 NE022 Electrode: Geltrode
50 / 50 / 50 NE025 Electrode: Sticktrode
1 NE027 Electrode: Earclip
1 NE172 USB Extension Cable
1 NE0 31b USB Wi- Fi Dongle
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Item Name / Description Code
Enobio Necbox (8ch/20ch/32ch)
u The Enobio Neuroelectrics Control Box (Necbox) is the core of the Enobio system.
u The Necbox is battery operated and it is wirelessly paired
with the computer using the NIC software.
u The 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
u The USB power adapter is used to charge the Necbox battery.
u The type of the power supply plug (EU/US/UK) included in
the kit depends on the country of the customer.
NE0 13/
NE055
NE0 13a
NE0 13b
NE0 13c
Curved Syringe
u The curved syringe is used to inject electrode gel in the electrodes.
u Wash and clean it after each use.
NE014
USB Stick with Manuals & NIC SW
u The USB stick contains the PDF version of the three parts of the
Neuroelectrics User Manual, and the NIC software.
u Both items can be also found at www.neuroelectrics.com.
NE0 15
20
Item Name / Description Code
Electrode Gel 250 cl
u The 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
u 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.
NE 017
10 Electrode Cable EN20/EN32
u This cable is included with Enobio 20 and Enobio 32, and is used together with NE018b.
u Its 10 cable connections are labelled with the positions:
u P7, P4, Cz, Pz, P3, P8, O1, O2, CMS & DRL
NE0 18a
12 Electrode Cable EN20/EN32
u This cable is included with Enobio 20 and Enobio 32, and is used together with NE018a.
u Its 12 cable connections are labelled with the positions:
u F7, T7, Fp1, F3, C3, Fz, Fp2, F4, C4, F8, T8, and EXT (EN20) or Oz (EN32).
NE0 18b
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Item Name / Description Code
12 Electrode Cable EN32
u This cable is included only with Enobio 32, and it is used together with NE018a and NEO18b.
u Its 12 cable connections are labelled with the positions:
u PO3, AF3, FC5, FC1, CP5, CP1, CP2, CP6, AF4, FC2, FC6, PO4
NE0 18c
Neoprene Headcap M (54cm)
u The Neoprene Cap is a comfortable solution to precisely place the electrodes on
the scalp based on the 10-10 system. It provides 39 possible electrode positions,
but extra positions can be added using the neoprene punch tool (not included).
The cap provided is medium sized, but other sizes are also available.
NE019 -M
Geltrode
u The Geltrode is the traditional EEG electrode that can be used in areas
with or withour hair. It requires the application of electrode gel.
Read the Electrode User Manual before using the Geltrode.
NE022
Sticktrode
u The sticktrode is a pre-gelled adhesive electrode used for the CMS & DRL reference channels.
It can be also used to monitor ECG or EOG. It does not require the application of electrode gel.
Read the Electrode User Manual before using the sticktrode.
NE025
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Item Name / Description Code
Earclip
u 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.
NE027
USB Dongle or USB Wi-Fi Dongle
u The USB Dongle is used to provide a Wi- Fi por t for computers that do not have an
incorporated port. The wireless communication between the Necbox and the computer
is through Wi-Fi. The USB Dongle must not be used with Mac OS computers.
NE031/
NE0 31b
USB Cable & Isolator
u The USB Cable & Isolator can be used to transmit EEG and Stimulation data between the
device and the computer. As we have aleady seen in the validation. This should always
be used with the extendor cable. Note that this cable does not charge the device.
N16 41/
NE172
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 nd:
u Different sizes of the neoprene headcap:
XL, L, M, S, Kids (K) and Kids Small (KS)
u The neoprene punch tool:
Customize your own neoprene cap!
u Mouse Headcap Cover:
Provide kids a funny EEG experience
u Dry electrodes for EEG monitoring:
For fast and gel-free EEG experiments
u Solid gel technology for EEG monitoring:
For fast and gel-free EEG experiments
These items are available upon request.
Please contact our sales team to learn more.
Mouse Headcap Cover
24
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.
IV.3
Necbox: Neuroelectrics Control Box
1. Charging LED
Yellow when charging; green when
charged.
2 ON/OFF Push-Button
3 Operation LED
The LED behind the logo indicates
normal operation of the device.
1
2
3
25
enobio 8
enobio
4 Pin connector slots
The number of slots
depends on the number of
the channels of the Enobio
(see next page).
5 MicroSD card slot
Slot for microSD card (Card
not included) for online data
storage in the “holter” mode.
6 Velcro
To attach the Necbox to the
neoprene cap.
7 Technical
Specications labels
Serial Number (SN), with
the EYYYYMMDD format,
where YYY Y, MM and DD
are the manufacturing year,
month and day, respectively.
MAC address of the device.
4
5
6
7
SN
MAC:
Input: 5 W, 4.8 - 5.5V
IP21
NEUROELECTRICS
BARCELONA
AV. Tibidabo 47 bis
08035 Barcelona
Spain
26
Enobio 32
Necbox
NE009
NE017 NE018a NE018 b NE018 c
R
R
First, the Necbox is attached to
the neoprene cap using the velcro.
Secondly, the Necbox should be
connected to the electrode cable(s).
The cables are inserted in the pin
connector slots of the Necbox as
described in the diagram below:
u Enobio 8
Only electrode cable N E 0 17,
should be connected to the Necbox
using the only available slot (blue).
u Enobio 20
The pair of cables NE018a
and NE018b that must be
connected to the green and
red slots, respectively.
u Enobio 32
Similarly to Enobio 20, but the
cable NE018c is added and
connected to the orange slot.
IV.4
Assembling the Necbox and the electrode cables
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
connected to the green slot while the remaining slots must be left empty.
Enobio 8
Necbox
NE010
Enobio 20
Necbox
NE002
27
The battery can only be charged when
the device is at the OFF position. The
battery charger connects to the Necbox.
The battery charger connects to the
Necbox through the microUSB connector
located at the rear part of the Necbox.
To charge the battery, the following
specications need to be met:
u Nominal output: 5V (4.25V - 7V)
u Current output: 1A
u Battery charger:
must comply according to
Standard IEC-EN 60601-1
u The battery state of charge is
measured by NIC when the
device is powered ON and
paired with the computer.
u The battery should not be over
discharged when the device is not
used for a long time. It should be
periodically charged instead.
u Overdischarging may cause
loss of cell performance and/
or damage to battery function.
u Expected life cycle:
> 500 cycles > 70% of initial capacity
u Charging with higher voltage than
specified may damage the cell.
u The usual time to charge a battery
from the cut-off voltage to the
maximum capacity is around 2 hours,
but it depends on each (battery life
and memory is a function of time).
u The device can be connected to
any Class 2 electrical installation.
u Device will not operate
when charging.
u Only use the charger that came with
the device to charge the battery.
Operating Temperature
u Charging: 0°C to 45°C
u Discharging: -20°C to 60°C
IV.5
Necbox battery
R
Electrical Specications
for charging:
u Voltage nominal input: 5 V DC
u Voltage input min/max: 4.25 V - 7 V
u Power input: 5 W
28
Necbox & Electrode Cable
The Enobio Necbox should be cleaned
using a dry paper towel after each use.
Neoprene Headcap
The Neoprene Headcap should be
cleaned and disinfected as it follows:
u Rinse off the gel with warm
tap water and ivory soap
u Dry the cap carefully
using a paper towel
u Spray the cap with disinfectant
and let it sit for 10 minutes, or
use disinfectant wet wipes
u Rinse the cap thoroughly
u Hang up the cap to dry
Electrodes
The cleaning instructions for the
electrodes can be found in the
Electrodes User Manual.
IV.6
Cleaning Instructions of the Enobio Kit
29
V. Symbols Used
Symbol Description
Refer to th e manual /booklet
General warning sign
IEC 60417-5010 Push ON/O FF button UNE-EN 60601-1=20 08
ISO 700 0-2498 Ser ial Number accordi ng to
UNE-EN 980
Device manufacturer symbol accor ding to
UNE-EN 980
ISO 700 0-2 606 d o not use device if p roduc t or pack aging have been
damage d symbol according to U NE-EN 980
Do not thr ow Enobio in gene ric was te symbo l.
WARNING! Whe n you want th row away th e devic e, NEV ER throw i t
in the trash, but go to the RECYCLAB LE POIN T or the ne arest waste
collection..
CE marke d device certied by the Notied Body
n. 0120 of the Eur opean C ommunity.
ISO 60 417-5140 Non-Ionizing
Electromagnetic radiation.
ISO 700 0- 0632 Transpor t and storage
temperature conditions
Symbol Description
ISO 700 0-2 620 Transpo rt and storag e
humidity conditions
ISO 700 0-2 621 Transpor t and st orage
atmospheric pressure conditions
Transpor t packa ge shall b e kept away fr om rain a nd in dr y condition.
Transport package shall not be exposed to sunlight.
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VI. Error Messages
The following messages might appear during normal operation:
Error message Cause Actions
Connection lost
The computer cannot communicate
with the device.
Check that the device is switched on, that
the device has battery, that the computer
is communicating properly, and the device
is close to the computer.
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VII. Electromagnetic
Compatibility (EMC)
Information
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The Enobio is suitable for use in the specied electromagnetic environment. The customer and/or user of the Enobio
should ensure that is used in an electromagnetic environment as described below:
Emissions
Test Compliance
Electromagnetic
Environment Guidance
RF Emissions
CISPR 11:2015 + A1:2016
Group 1
The Enobio uses RF energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
RF Emissions
CISPR 11:2015 + A1:2016
Class B
The Enobio is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
Harmonic Emissions
UNE-EN 61000-3-2:2014
Class A
Voltage uctuations/icker emissions
UNE-EN 61000-3-2:2013
Complies
For Professional Use
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Immunity
Test
IEC 60601-1-2
Test Level
Compliance
Level
Electrostatic discharge (ESD)
UNE-EN 61000-4-2:2010
+- 8 kV contact +- 8 kV contact
+- 15 kV air +- 15 kV air
Electrical fast transient/burst
UNE-EN 61000-4-4:2013
2 kV for power supply lines 2 kV for power supply lines
1 kV for input/output lines N/A
Surge
UNE-EN 61000-4-5:2015
1 kV differential mode 1 kV differential mode
2 kV common mode N/A
Voltage dips, short interruptions and
voltage variations
on power supply
input lines
UNE-EN 61000-4-11:2005
0% U; 0.5 cycles at 0º, 45º,
90º, 135º, 180º, 225º,
270º and 315º
0% U; 0.5 cycles at 0º, 45º,
90º, 135º, 180º, 225º,
270º and 315º
0% U; 1 cycle 0% U; 1 cycle
70% U; 25 cycles single
phase at 0º
70% U; 25 cycles single
phase at 0º
0% U; 250 cycles 0% U; 250 cycles
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8:2011
30 A/m 30 A/m
The Enobio image intensier is suitable for use in the specied electromagnetic environment. The customer and/or the
user of Enobio image intensier should ensure that it is used in an electromagnetic environment as described below:
Note: U is the A/C main’s voltage prior to application of the test level.
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Immunity
Test
IEC 60601-1-2
Test Level
Compliance
Level
Conducted RF
UNE-EN 61000-4-6:2014
3 Vrms
0.15 MHz - 80 MHz
6 Vrms in ISM bands between
0,15 MHz and 80 MHz
80% AM at 1 kHz
3 Vrms
0.15 MHz - 80 MHz
6 Vrms in ISM bands between
0,15 MHz and 80 MHz
80% AM at 1 kHz
Radiated RF
UNE-EN 61000-4-3:2007 +
A1:2008 + A2:2011
UNE-EN 61000-4-3:2007 +
A1:2008 + A2:2011
UNE-EN 61000-4-3:2007 +
A1:2008 + A2:2011
The Enobio is suitable for use in the specied electromagnetic environment. The customer and/or the user of Enobio
should ensure that it is used in an electromagnetic environment as described below:
(a) Field strengths from xed transmitters, such as base stations
for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast, and T V broadcast
cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to xed RF transmitters, an
electromagnetic site survey should be considered. If the measured
eld strength outside the shielded location in which the Enobio
is used exceeds the applicable RF compliance level above, the
Enobio should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary,
such as re-orienting or relocating the Enobio. (b) Over the
frequency range 150 kHz to 80 MHz, eld strengths should be less
than 3 V/m.
NOTE 1: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reection from structures, objects and people.
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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
above, the separation distance can be estimated using the
equation in the corresponding column, where P is the maximum
output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reection from structures, objects, and people.
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