Neuroelectrics User Manual
Starstim 8 / Starstim tcs
CAUTION: INVESTIGATIONAL DEVICE
Limited by United States law to investigational use.
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
Copyright© by Neuroelectrics®. All rights reserved.
The manufacturer should be contacted:
- for assistance, if needed, in setting up, using or maintaining the Starstim 8 system;
- to report unexpected operation of events that result from the usage of the device.
Manufacturer:
Neuroelectrics Barcelona SLU
Avinguda Tibidabo 47, bis
08035 Barcelona
Spain
Telephone: + 34 93 254 03 70
Brand:
Starstim
Models:
Starstim 8
Starstim tcs
Input: 5W, 4.8 - 5,5V
4
About the Starstim User Manual
The Starstim User Manual belongs to the Part I of the
Neuroelectrics User Manual.
The Neuroelectrics User Manual includes three parts:
u Part I: Starstim User Manual
u Part II: Electrode User Manual
u Part III: NIC User Manual
Before you rst use the Starstim system, you should read
the three parts of the Neuroelectrics User Manual. The
Starstim 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 in three parts:
(1) Enobio / Starstim, (2) Electrode and (3) NIC.
2.1 2016.05.10 Starstim tCS info added to Starstim 8 manual
2.2 2017. 07. 2 5 Product contents update (Starstim tCS info removed).
2.3 2017.08.23 Regulatory info update
2.4 2018.05.07
Starstim BT and Wi-Fi unied and Starstim tCS info added to
Starstim 8 manual
Change of Record
6
About the Starstim User Manual ......................................... 4
Change of Record ............................................................... 5
I. Use of Starstim ............................................................ 7
I.1 Transcranial Current Stimulation (tCS) ...................... 8
I.2 Intended Use .............................................................9
I.3 Conditions of Use .................................................... 10
II. Quality and Regulatory Information ....................... 11
II.1 Quality Management System ................................ 12
II.2 Medical Device Regulations .................................. 12
II.3 For US Audience only ........................................... 12
III. Safety Information .................................................... 13
III.1 Safety Warnings ................................................... 14
IV. The Starstim System ................................................. 16
IV.1 Features ................................................................. 17
IV.2 Technical Specications........................................ 17
IV.3 Contents of the Starstim package ......................... 19
IV.4 Necbox: Neuroelectrics Control Box ..................... 25
IV.5 Assembling the Necbox ........................................27
IV.6 Necbox battery ...................................................... 27
IV.7 Cleaning Instructions ............................................. 28
V. Symbols Used ............................................................29
VI. Error Messages ......................................................... 30
VII. Electromagnetic Compatibility
(EMC) Information .....................................................31
Table of Contents
7
I. Use of Starstim
Starstim 8 is a modern neurostimulator:
Starstim 8 is a transcranial current stimulation (tCS) and
an electroencephalogram (EEG) monitoring device, all in one.
u It is a wireless operating system
u EEG recording is possible before,
during and after stimulation
u Multiple independent stimulation
channels improve the spatial
distribution of the electric field
u Variety of waveforms for
stimulation current: tDCS,
tACS, tRNS and Sham mode
u Pistim: the new hybrid Ag/
AgCl electrode that can be
used for EEG or tCS
u Ease of use despite of the
complexity of the technology
u Safety features such as maximal
currents and impedance control
8
I.1
Transcranial Current Stimulation (tCS)
Transcranial current stimulation (tCS)
is a neurophysiological technique
capable of modulating the excitability
of the neuronal tissue of the central
and peripheral nervous system
through the application, for a nite
time length, of an electrical eld.
This electric eld is generated by the
application of weak electrical currents
through the scalp and into the brain.
It has been demonstrated in recent
years that the technique is safe
and benecial if used within the
known bounds of intensity, density
and duration. Nevertheless, its
application must be controlled by
specialized medical personnel able to
guarantee the application of correct
stimulation parameters.
Brain stimulation can be performed
only under medical prescription
or under the supervision of an
appropriate Ethics Committee as
regulated in each country of intended
use.
The tCS technique is classied
into three types according to the
waveform of the stimulation current
that is applied: tDCS, tACS and
tRNS. Additionally, the Sham
mode can be used for controlled
experiments.
Transcranial Direct Current
Stimulation (tDCS)
tDCS is the most popular tCS
technique, and it is described by
stimulation currents that are held
constant, like DC current. In general,
the current is injected into the brain
(anodal stimulation) over a cortical
region leading to excitatory effects;
and collected from the brain (cathodal
stimulation) leading to inhibitory
effects. tDCS produces short term
effects on neuronal excitability, and
long lasting plastic after/effects
involving synapticl modication.
Transcranial Alternating Current
Stimulation (tACS)
tACS is a form of tCS in which
the stimulation currents are time
dependent with a sinusoidal shape,
like AC current. Amplitude, frequency,
and relative phases across stimulation
electrodes can be dened. tACS
provides a powerful way to couple
with the oscillatory behaviour of the
brain, which is at the present an active
research eld in basic and clinical
Neuroscience.
Transcranial Random Noise
Stimulation (tRNS)
tRNS is a type of tCS in which the
stimulation currents are randomly
varied. Unlike tDCS, tRNS has
been recently introduced to the
Neuroscience community, and there
9
is little experience with it. However,
it appears as if its main effect are
excitatory. The lower and upper
values of the band frequency of the
stimulation signal can be chosen
between 0 to 500 Hz.
Sham stimulation mode
Sham stimulation is the term used
to describe an inactive form of
stimulation which is used in research
to control the placebo effect.
Starstim 8 and Starstim tcs
Starstim 8 and Starstim tcs are
neurostimulator devices. They have
been designed for research use only,
in a clinical environment, hospital,
or research center. Starstim 8 and
Starstim tcs must be always used
according to the brain stimulation
applications already described in
the literature. In any other case,
the supervision of a local Ethics
Commitee or analogous Body must be
required for the experimental use of
this device.
Starstim 8 and Starstim tcs can only
be used with electrodes and cables
commercialized by Neuroelectrics.
Read the Neuroelectrics User Manual
carefully before using Starstim 8 or
Starstim tcs.
Starstim 8 and Starstim tcs are
research use only devices.
I.2
Intended Use & Use Environment
10
Starstim must be used with normal
temperature, humidity, and pressure
conditions:
u Temperature Range: +5 to 40 °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
Conditions of Use
11
II. Quality
and Regulatory
Information
12
Neuroelectrics is an ISO 13485
and ISO 9001 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.
Europe
In Europe, Starstim 8 is intended for
research use only.
Canada
In Canada, Starstim 8 is approved
as a medical device and it conforms
with the Canadian Medical Device
Regulations SOR/98-282.
CAUTION:
US Federal Law classies
Neuroelectrics® Starstim 8 as an
Investigational Device.
II.1
Quality Management
System
II.2
Medical Device
Regulations
II.3
For US
Audience only
13
Starstim 8 conforms to the following standards:
Electrical Safety
u EN 60601:2006 + Err.:2008 + Corr:2010
+ AC:2013 + A11:2011+ A12:2014
u EN 60601-1-6:2010
u EN 60601-1-11:2015
u EN 60601-2-26:2015
Electromagnetic compatibility
u EN 60601-1-2:2015
u EN 55011:2016 + A1:2017
u EN 61000-3-2:2014
u EN 61000-3-3:2013
u EN 61000-4-2:2009
u EN 61000- 4-3:2006 + A1:2008 + A2:2010
u EN 61000-4-4:2012
u EN 61000- 4-5:2014 + A1:2017
u EN 61000-4-6:2014
u EN 61000-4-8:2010
u EN 61000- 4-11:2004 + A1:2017
Medical device software life-cycle
u EN 62304:2006 + Corr.:2009 + AC:2010
Biological evaluation
u EN ISO 10993-1:2009 + AC:2010
Usability
u EN 62366-1:2015 + AC:2015
Others
u EN ISO 980:2008
u EN ISO 15223-1:2016
u EN 1041:2008 + A1:2013
u EN 60529:1991 + A1:2000 + A2:2013
u EN ISO 14971:2012
u 2011/65/EU
III. Safety Information
14
W Note for clinical use: Brain
stimulation must be always used
according to medical prescription.
W Brain stimulation must be used AFTER
the prescription of a stimulation
protocol made by the specialized and
qualied medical personnel who owns
and operates the Starstim Sof tware.
W Before the brain stimulation is
prepared, please inform the
prescribing clinician or operator of
the presence of any pacemakers,
intracranial electrodes, implanted
debrillators, cranial pathologies
(e.g. holes, plaques) or any other
prosthesis. In these cases the use of
the device could become unsafe.
W Before using, please check that
the device is undamaged and the
packaging has not been affected
by transport or storage.
W In the case of malfunction,
immediately contact the
manufacturer or the distributor.
W The device must never be
opened or damaged.
W The battery can only be replaced
by authorized personnel.
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
during stimulation or while
EEG monitoring is on.
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 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 For EEG monitoring, the device must
be used with Ag/AgCl electrodes
recommended by the manufacturer.
W For stimulation, Ag/AgCl electrodes
or carbon rubber electrodes
with sponges soaked with saline
solution can be used. The sponges
must be bigger than 3 mm2 to
avoid high density currents.
W The device is not protected against
other high frequency devices.
To avoid risks place the CMS/
DRL as far as possible from the
stimulation and return electrodes
of the high frequency device.
W The device is wireless and might
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
has been tested using the 10wire or 12-wire 34 cm cables
provided with the system.
W The use of cables or electrodes other
III.1
Safety Warnings
15
than the ones delivered with the
product might produce higher EMC
emissions and less EMC immunity.
W The device cannot be used beside
or piled under other equipment.
If such usage is needed, check
the normal conguration.
W The device can only be used in
healthy skin without wounds.
W The device cannot be
used in a 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 to another device
connected to the patient, the user
should contact Neuroelectrics to
check the correct simultaneous use.
W Starstim should not be used in an
MRI room or close to CT, diathermy,
RFID and electromagnetic security
systems such as metal detectors. In
the case that there exist RF emitters
(e.g. RFID), which might not be
visible, the device can potentially
be exposed to elds from these RF
emitters without the user’s awareness
and corrupts the signal acquisition.
If NIC detects that the signal is
very noisy, it will interference with
a higher Signal Quality Index.
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 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 Keep out of reach from children and
anyone else who might swallow
electrodes, otherwise they may
cause injury to themselves.
W Keep out of reach from children and
anyone else who might strangle
with the cables of the devices.
W The result of the recordings must be
analysed by a doctor or specialist.
No self medication should be
done based on this results.
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.
W If the system encounters the
communication between Starstim
and the PC is failed, then the
NIC software will inform the user
accordingly. Additionally, Starstim
incorporates an internal buffer that
safeguards the information sent from
the device to the PC. So, even if there’s
a problem of the communication
16
IV. The Starstim
System
This chapter describes the Starstim system. First, it lists
the features and technical specications of Starstim. Then,
the components included in the Starstim and Starstim tCS
packages are listed and described. For each item, you may
nd the product code, the product name, a picture and a
short description of its function. Lastly, it describes the
Neuroelectrics Control Box (Necbox) which is the core and
the control unit of Starstim.
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, you
should read the NIC User Manual. The NIC User Manual
explains the steps needed to correctly conduct a stimulation
session, with or without simultaneous EEG monitoring
17
Wireless, wearable
and easy-to-set concept
u Flexible electrode placement
based on the 10-10 system
u Conduct mobile studies away
from the clinic or lab
u User-friendly software interface
u Stimulation waveforms:
tDCS, tACS and tRNS
u Sham and double-blind modes
EEG monitoring and Stimulation *
u Stimulation compatible with
simultaneous EEG monitoring
(not in the same site)
u Stimulation and EEG monitoring are
possible at the same site with the
same electrode (not simultaneously)
u EEG monitoring is possible before,
during and after stimulation
IV.1
Features
EEG functionality *
u Number of channels:
(up to) 8 channels
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
u Common mode rejection
ratio: -115 dB
u Input impedance: 1 GΩ
Stimulation functionality
u Number of channels:
(up to) 8 channels
u Sampling rate: 1000 SPS
u Frequency range: 0 to 250 Hz
(tACS) and 0 to 500 Hz (tRNS)
u Stimulation types: linear
combination of tDCS, tACS
and tRNS; and Sham
u Maximum current per
channel: ± 2 mA
u Current resolution: 1 µA
u Current accuracy: 1%
u Maximum voltage: +- 15V
per electrode (allows 30 V of
stimulation potential difference)
Stimulation safety features
u Maximum input current
per channel: 2 mA
u Maximum total inject current: 4 mA
(by all electrodes, at any time)
u Maximum duration per
session: 1 hour
u Stimulation session must
be pre-programmed
u Electrode impedance check
before and during stimulation
u Abort functionality possible
at any instant
IV.2
Technical Specications
*EEG monitoring is not avaliable with Starstim tCS.
All
Channels
Wi-Fi SS 8 5 h 10 min
USB SS 8 11 h 56
min
BT SS 8 6 h 15 min
Battery Operating TImes
18
Other Technical Specications
u Battery operating time:
8 hours (combined EEG/tCS use)
u Accelerometer: 3-axis
u Communication:
NE001: Bluetooth® 3.0 and 2.1
NE001WF: Wi-Fi IEEE 802.11 b/g/n
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
Minimum Computer Requirements
u Operating System: Windows Vista
or MAC OS X Snow Leopard
u Processor: 1.3 GHz
u RAM: 2 GB
u Bluetooth®: 2.1/Wi-Fi/USB
u NE001: Buetooth® 2.1 EDR
u NE001WF: Wi-Fi IEEE802.11g
Wireless Information
Starstim is a wireless device operating
at the 2.4GHz Industrial Medical and
Scientic (ISM) band. The Nexbox
connects through the wireless link
to the Neuroelectrics Instrument
Controller (NIC) software running on a
computer. The EEG data is streamed
through the wireless link. The standard
operating distance is 10 meters.
Below are the technical specications
regarding the Wireless connection
used by Necbox.
NE001 - Wireless Specifications
u Bluetooth 3.0 and 2.1 Class 2
u Operating frequency band:
from 2.400 to 2483.5 MHz
u Transmitting power: Max. +3dBm
u Qualifications: CE, FCC, IC,
Japan and South-Korea
u Data rate: 921600 BPS
NE001WF- Wireless Specifications
u Wi-Fi: IEEE 802-11 b/g/n
u Operating frequency band:
from 2.412 to 2472 MHz
u Transmitting power: Max. +16dBm
u Qualifications: CE, FCC, IC,
Japan and South-Korea
u Data rate: 921600 BPS
u Security details: Encryption WEB
IV.2
Technical Specications
19
20
The Neuroelectrics® Starstim 8 package contains all the
components required to per form an EEG monitoring or
stimulation session, and some additional items that may
be useful during your experiments. Once you have opened
the box, please conrm you have all the items listed below
as well as the right quantity of each electrode model.
Depending on the communication of your device, items
included can vary.
IV.3
Contents of the Starstim 8 package
Quantity Code Name
1
NE012 /
NE012WF
Starstim Necbox
1
NE013 /
NE055
USB Power Adapter
1
NE013a
NE013b
NE013c
EU / US / UK
Power Supply Plug
1 NE014
Curved Syringe
1 NE015
USB Stick with Manuals & NIC
1 NE016a
Electrode Gel 250cl
1 N E017
10 Electrode Cable
1 NE019-M
Neoprene Headcap M (54 cm)
8 NE022
Electrode: Geltrode
8 NE024
Electrode: Pistim
Quantity Code Name
50 NE025
Electrode: Sticktrode
4 NE026a
Electrode: Sponstim 25
4 NE026b
Electrode: Sponstim 8
1 NE027
Electrode: Earclip
1
NE031 /
NE0 31b
USB Bluetooth Dongle / USB Wi-Fi
Dongle
1 NE033
Saline Solution 100 ml
1 NE038
Testboard Head
1 NE039
Testboard Cable
1 NE043
USB Charging Cable (Bluetooth
devi ces)
1
NE0164/
NE17 2
USB Cable & Isolator (Wi-Fi / USB
devi ces)
21
In this page we present the
electrodes included in the
package, but you must read the
Electrode User Manual to learn
how to use, to assemble and to
clean the electrodes. Additionally,
in the following three pages, there
is a list of the rest of the items
of the package and each item is
identied with its name and code.
Neuroeletrics Electrodes
EEG
Geltrode
NE022
Stimulation (tCS)
Sponstim 25
NE026a
Sponstim 8
NE026b
EEG & tCS
Pistim
NE024
Reference
Sticktrode
NE025
Earclip
NE027
Regarding the electrodes, you must use them according to their functionality. They are grouped
above as only-EEG, only-tCS, hybrid EEG & tCS, and Reference electrodes. Bear in mind that
electrodes need to be replaced when they reach the end of their lifetime, in order not to compromise
the quality of the EEG signal or the efcacy of the stimulation.
22
Item Name / Description Code
Starstim Necbox
u The StarStim Neuroelectrics Control Box (Necbox) is the core of the Starstim 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 when the device is being used.
NE012 /
NE012WF
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.
NE055 /
NE033
&
NE013a
NE013b
NE013c
Curved Syringe
u The curved syringe is used to inject either electrode gel or saline solution in the electrodes.
u Do not use electrode gel and saline solution simultaneously in the
syringe. Wash and clean it when changing the liquid to be used.
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.
NE015
23
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, bet ween the electrode and the scalp, in order to decrease the
impedance and improve the signal quality. It must not be used with sponstim electrodes.
NE016a
Saline Solution 100 ml
u The saline solution (NaCl 0.9%) is required to use the stimulation sponstim electrodes.
u It should be applied on the yellow exterior face of the sponge that contacts with the scalp.
NE033
10 Electrode Cable
u The 10 electrode cable has 10 electrode medical sockets compatible
with the electrodes commercialized by Neuroelectrics.
u It contains 8 channels for EEG monitoring or for stimulation, and
two reference channels labelled with CMS & DRL.
NE017
Neoprene Headcap M (54 cm)
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
24
Item Name / Description Code
USB Bluetooth Dongle or USB Wi-Fi Dongle
u The USB Dongle is used to provide a Bluetooth®/Wi-Fi port for computers
that do not have an incorporated port. The wireless communication between
the Necbox and the computer is through Bluetooth®/Wi-Fi. The USB
Bluetooth/Wi-Fi Dongle must not be used with Mac OS computers.
NE031/
NE0 31b
Testboard Head
u The testboard head alllows you to test the system functionalities and rule out
potential problems before the real experiment. The necbox can be connected
to the testboard using either the testboard cable or the 10 electrode cable.
When the device is connected to the testboard, it responds as a properly placed
system on the subject’s scalp, with a ver y similar electrical environment.
NE038
Testboard Cable
u The testboard cable is the simplest way to connect the necbox with
testboard head. This cable is not needed if you choose to connect the
necbox and the testboard head using the electrode cable.
NE039
USB Charging Cable (only included in Starstim 8 system)
u The USB charging cable is an alternative to the USB power adapter & power supply plug.
u It allows the necbox to be charged by connecting it to the computer.
NE043
25
Item Name / Description Code
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.
u Read p. 29 to hearn how to use the Isolator Cable.
NE164 /
NE17 2
In order to make your Starstim experience more complete,
you can add accessories to your stimulation kit.
In our catalog and webpage, you may nd:
u Different sizes of the neoprene
headcap: XL, L, M, S, Kids
u The neoprene punch tool to
customize your own cap.
u Mouse Headcap Cover
provides kids a fun
EEG experience
u Dry electrodes and solid gel
technology for EEG monitoring
for a fast, gel-free experience
u Different shapes of the sponge
electrodes
Cicular 25 cm² o r 8 cm², or
rectangular 5 cm x 7 cm, you
choose the contact area.
u MRI kit (Filter & Harness) and
MRI compatible electrodes:
Take your hybrid EEG/tCS
system to the MRI room
These items are available upon
request.
Please contact our sales team if
you want your Starstim to be more
complete.
26
The Necbox is the core
and the control unit of
Starstim. The Necbox
is a battery operated
device. It weighs 85 g
and its dimensions
are 87 mm x615 mm x
24.8 mm. The following
diagrams describe the
details of the Necbox
IV.5
Necbox: Neuroelectrics Control Box
1. Charging LED
Yellow when charging; green
when charged.
2 Charging connector
To charge the Necbox
battery either using the
power adapter or the USB
charging cable (Bluetooth
only).
3 ON/OFF Push-button 4 Operation LED
The LED behind the logo
indicates the normal
operation of the device.
1
2
3
4
27
5 Pin connector slots
10-pin slot to connect with
the electrode cable.
6 MicroSD card slot
Slot for microSD card (Card
not included) for online data
storage in the “holter” mode.
7 Velcro
To attach the Necbox to the
neoprene cap.
8 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.
5
6
7
8
SN
MAC:
Input: 5 W, 4.8 - 5.5V
IP21
NEUROELECTRICS
BARCELONA
AV. Tibidabo 47 bis
08035 Barcelona
Spain
28
R
R
The Necbox is attached to the
neoprene cap using the velcro, and
it is connected to the electrode cable
using the 10-pin connector.
The battery can only be charged
when the power switch is at the OFF
position. The battery charger connects
to the Necbox through the microUSB
/ micro HDMI connector located at the
rear part of the Necbox. To charge the
battery, the following specications
need to be met:
u Nominal output: 3.7 V (3 V - 4.2 V)
u Current output: 1 A
u Battery charger: must comply
according to Standard EN
60601-1:2006 + A12:2014
u The battery state of charge is
measured by NIC when the
device is switched 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:
After 500 > 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 (battery life).
u The device can be connected to
any Class 2 electrical installation.
Operating Temperature
u Charging: 0° C to 45° C
u Discharging: -20° C to 60° C
Storage Temperature
u 1 year at -20 ºC to 65 ºC
IV.6
Assembling the Necbox
IV.7
Necbox battery
29
R
Electrical specications for charging:
u Voltage nominal input: 5 VDC
u Voltage input min/max:
4.8 VDC - 5.5 VDC
u Power input: 5 W
Output current specications:
u 2 mA per channel with ± 15 V
Necbox & Electrode Cable
The Starstim 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 the gel with warm tap
water and ivory soap
u Dry the cap conscientiously
using 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.8
Cleaning Instructions
30
V. Symbols Used
Symbol Description
ISO 7010- W001 War ning si gnal ac cording to UN E-EN 6 0601-1=2008
Parts marked w ith this symbol a re not protecte d agains t debr illator.
IEC 60417-5 008 S witch O FF according t o
EN 60601-1:2006
IEC 60417-5 007 Sw itch ON a ccor ding to
EN 60601-1:2006
ISO 700 0-2498 Ser ial Number accordi ng to
EN 980:2008
Device manufacturer symbol accor ding to
EN 980:2008
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
colle ction for fur ther t reatm ent, thu s contributing to envi ronme ntal
care.
CE marke d device certied accor ding to the Europ ean Com munit y.
ISO 60 417-5140 Non-Ionizing
Electromagnetic radiation.
Symbol Description
ISO 700 0- 0632 Transpor t and storage
temperature conditions
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
IP 21
This medical device is p rotec ted fro m objec ts not greater th an 12 mm
in diameter and pr otecte d from dr ippin g water.
Transpor t packa ge shall b e kept away fr om rain a nd in dr y conditions.
Transport package shall not be exposed to sunlight.
ISO 7010-W001 General warning sign.
Refer to th e manual /booklet
31
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
Bluetoot h/ Wi-Fi / USB communication is
working properly, and the device is close
to the computer.
Please switch off the device,
and after 5 seconds
The computer has the device paired,
but the device is at unknown state.
Restart the device.
32
VII. Electromagnetic
Compatibility (EMC)
Information
33
The Starstim is suitable for use in the specied electromagnetic environment. The customer and/or user of the
Starstim 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 Starstim 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 Starstim 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
EN 61000-3-2:2014
Class A
Voltage uctuations/icker emissions
EN 61000-3-3:2013
Complies
For Professional Use
34
Immunity
Test
IEC 60601-1-2
Test Level
Compliance
Level
Electrostatic discharge (ESD)
EN 61000-4-2:2009
+-8 kV contact +-8 kV
+-15 kV air +-15 kV
Radiated RF
EN 61000-4-3:2006 +
A1:2008 + A2:2010
3 V/m
80 MHz to 2,5 GHz
3 V/m
80 MHz to 1 GHz
Electrical fast transient/burst
EN 61000-4-4:2012
2 kV for power supply lines 2 kV for power supply lines
1 kV for input/output lines N/A
Surge
EN 61000-4-5:2014 +
A1:2017
1 kV differential mode 1 kV differential mode
2 kV common mode N/A
Conducted RF
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
Power frequency
(50/60 Hz) magnetic eld
EN 61000-4-8:2010
30 A/m 30 A/m
The Starstim image intensier is suitable for use in the specied electromagnetic environment. The customer
and/or the user of Starstim 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.
35
The Starstim is suitable for use in a professional healthcare facility environment except near HF surgical equipment and
the RF shielded room for magnetic resonance imaging.
The essential performance of the Starstim is the measure of the EEG and the transcranial stimulation. In case of EM
disturbances, the operator can experience lost of communication between the Starstim and the PC.
The only part replaceable of the Starstim are the patient cables (NE017).
Immunity
Test
IEC 60601-1-2
Test Level
Compliance
Level
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
EN 61000-4-11:2004 +
A1:2017
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
WARNI NG: Use of this equipment adjacent or stacked with other equipment
should be avoided because it could result in improper operation. If such use
is necessary, this equipment and the other equipment should be obser ved
to verif y that they are operating normally.
WARNI NG: Use of accesories, transducers and cables other than those
specied or provisioned by the manufacturer of this equipment could result
in increased electromagnetic emissions or decreased electromagnetic
immunit y of this equipment and result in improper operation.
WARNI NG: 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 Starstim, including cables
specied by the manufacturer. Otherwise, degradation of the per formance
of this equipment could result.
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