Neuroelectrics Enobio 8 User manual

getting started
Neuroelectrics User Manual
- Part 0. Getting Started -

2
Manufacturer:
Neuroelectrics Barcelona SLU
Avinguda Tibidabo 47, bis
08035 Barcelona
Spain
Telephone: + 34 93 254 03 66
Manual Update:
Version: 1.0
Date: 2019.05.27
The manufacturer should be contacted:
- For assistance in setting up, using or maintaining the system or to report an unexpected operation
of events that result from the usage of the device.
Input: 5W, 4.25 - 5 V

Applies to:
Enobio 8
Enobio 20
Enobio 32
These devices comply with the essential
requirements of the applicable EU Directives
(93/42/CEE), to demonstrate safety and
efficacy of the device.
The mark specifies the requirements for
the Quality Management System of the
Medical Devices manufacturer and aims to
demonstrate that the Medical Devices and
related services are complying with the legal
requirements and the final customer needs
Applies to:
Enobio Research 8
Enobio Research 20
Enobio Research 32
These devices are not medical, only for
INDUSTRIAL purpose.
The mark specifies that the products sold
in the European Economic Area (EEA) have
been assessed to meet high safety, health,
and environmental protection requirements.
It demonstrates the safety of the device.
Investigational Medical Device
Applies to:
Starstim 8
Starstim tCS
Starstim 20
Starstim 32
These devices are the subject of a clinical
study designed to evaluate the effectiveness
and/or safety of the device following the
regulations in the investigation in each
country. They are labelled as Research Use
Only.
The mark covers the same assessments
for high safety, health, and environmental
protection as the Industrial CE Mark.
Labelling of the covered products
3

I. General Information .................................................... 5
I.1 General Safety Warnings........................................... 5
I.2 Symbols Used............................................................ 6
II. Getting Started with the Device ................................. 7
II.1 How do I switch on the device?................................ 7
II.2 What if the device does not switch on? .................. 8
II.3 How do I connect to the device? ............................. 9
II.4 How do I access the full instructions for use? ........11
Table of Contents
4

WBefore applying the device,
connect to NIC and follow the
steps in the instructions for
use including the full list of the
safety warnings detailed.
WThe device cannot be turned on
while it is connected to the main
power supply through the power
adapter. The isolation of the main
power supply is achieved by
disconnecting the power adapter.
WThe device must never be
opened or damaged.
WBefore using, please check that
the device is not damaged and
the packaging has not been
affected by transport or storage.
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.
WThe device shall be connected to
the power adapter in a way that
makes it easy to disconnect.
WThe EEG feature of the device will
not function 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 modification of the
device is not allowed.
WIf the device has not been used during
a long period of time, check visually
that there is no battery leakage.
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.
I.1
General Safety Warnings
5

I.2
Symbols Used
Symbol Description
Refer to the manual/booklet
General warning sign
IEC 60417-5010 Push ON/OFF button UNE-EN 60601-1=2008
ISO 7000-2498 Serial Number according to
UNE-EN 980
Device manufacturer symbol according to
UNE-EN 980
Do not throw Enobio in generic waste symbol.
WARNING! When you want throw away the device, NEVER throw it
in the trash, but go to the RECYCLABLE POINT or the nearest waste
collection..
CE marked device certied by the Notied Body
n. 0120 of the European Community.
CE marked device certied according
to the European Community
ISO 60417-5140 Non-Ionizing
Electromagnetic radiation.
ISO 7000-0632 Transport and storage
temperature conditions
Symbol Description
ISO 7000-2620 Transport and storage
humidity conditions
ISO 7000-2621 Transport and storage
atmospheric pressure conditions
Transport package shall be kept away from rain and in dry condition.
Transport package shall not be exposed to sunlight.
IEC 60417-5333 BF Type applicable part according to UNE-EN 6061
Direct Current symbol
6

II.1
How do I switch on the device?
A
1Push the power button (A) on the
device.
2Ensure the operation LED (B) in
front of the device goes on.
B
A B
Key:
APower Button
BOperation LED
7

II.2
What if the device does not switch on?
1Take out the power adapter from the
kit’s packaging box and plug it to the
power outlet.
2Connect the power adapter to the
micro-HDMI connector (C) on the
device.
3Ensure that the charging LED (D)
goes on with the yellow light.
4Wait until the charging LED (D)
color goes green. You will be able to
C
D
R
C
D
Key:
CMicro-HDMI Connector
DCharging LED
8

II.3
How do I connect to the device?
1Ensure the device is switched on
following the steps in Section II.1.
2 On the label placed on the back
of your device, verify its unique MAC
address (E).
3In NIC2 Home pane, select the
type of the device connection (F). My
Devices pane will open.
4Wait a moment until your device
MAC appears on the list.
5If the device MAC did not appear,
click Scan for Devices (G). Repeat the
scan for up to a minute until the device
appears.
SN
MAC:
Input: 5 W, 4,25 -7V
NEUROELECTRICS
BARCELONA
AV. Tibidabo 47 bis
08035 Barcelona
Spain
IP21
E
F
G
Key:
EMAC Address on the Device Label
FConnection Selection in Home Pane
G Scan for Devices Button
9

II.3
How do I connect to the device?
6Choose your device from the list.
Settings pane will open.
7At the bottom of Settings pane,
click Use this Device (H).The software
will establish connection with the
device.
Key:
H Use this Device button
H
10

II.4
How do I access the full instructions for use?
1 Ensure the NIC2 software is
connected to the device following the
steps in Section II.3.
2 On the bottom of NIC2 left menu,
click the Instructions for Use button (I).
You will find all relevant instructions to
continue your work with the device.
Key:
IInstructions for Use button
I
11