Neuroelectrics Starstim 8 User manual

Neuroelectrics User Manual
Starstim 8 / Starstim tcs
CAUTION: INVESTIGATIONAL DEVICE
Limited by United States law to investigational use.

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
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:
uPart I: Starstim User Manual
uPart II: Electrode User Manual
uPart 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 2 017. 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 unied 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 Specications........................................ 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.
uIt is a wireless operating system
uEEG recording is possible before,
during and after stimulation
uMultiple independent stimulation
channels improve the spatial
distribution of the electric field
uVariety of waveforms for
stimulation current: tDCS,
tACS, tRNS and Sham mode
uPistim: the new hybrid Ag/
AgCl electrode that can be
used for EEG or tCS
uEase of use despite of the
complexity of the technology
uSafety 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 benecial 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 classied
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 modication.
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 dened. 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:
uTemperature Range: +5 to 40 °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
Conditions of Use

11
II. Quality
and Regulatory
Information

12
Neuroelectrics is an ISO 13485
and ISO 9001 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.
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 classies
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
uEN 60601:2006 + Err.:2008 + Corr:2010
+ AC:2013 + A11:2011+ A12:2014
uEN 60601-1-6:2010
uEN 60601-1-11:2015
uEN 60601-2-26:2015
Electromagnetic compatibility
uEN 60601-1-2:2015
uEN 55011:2016 + A1:2017
uEN 61000-3-2:2014
uEN 61000-3-3:2013
uEN 61000-4-2:2009
uEN 61000-4-3:2006 + A1:2008 + A2:2010
uEN 61000-4-4:2012
uEN 61000-4-5:2014 + A1:2017
uEN 61000-4-6:2014
uEN 61000-4-8:2010
uEN 61000-4-11:2004 + A1:2017
Medical device software life-cycle
uEN 62304:2006 + Corr.:2009 + AC:2010
Biological evaluation
uEN ISO 10993-1:2009 + AC:2010
Usability
uEN 62366-1:2015 + AC:2015
Others
uEN ISO 980:2008
uEN ISO 15223-1:2016
uEN 1041:2008 + A1:2013
uEN 60529:1991 + A1:2000 + A2:2013
uEN ISO 14971:2012
u2011/65/EU
III. Safety Information

14
WNote for clinical use: Brain
stimulation must be always used
according to medical prescription.
WBrain stimulation must be used AFTER
the prescription of a stimulation
protocol made by the specialized and
qualied medical personnel who owns
and operates the Starstim Software.
WBefore the brain stimulation is
prepared, please inform the
prescribing clinician or operator of
the presence of any pacemakers,
intracranial electrodes, implanted
debrillators, cranial pathologies
(e.g. holes, plaques) or any other
prosthesis. In these cases the use of
the device could become unsafe.
WBefore using, please check that
the device is undamaged 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 must never be
opened or damaged.
WThe battery can only be replaced
by authorized personnel.
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
during stimulation or while
EEG monitoring is on.
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.
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.
WFor EEG monitoring, the device must
be used with Ag/AgCl electrodes
recommended by the manufacturer.
WFor stimulation, Ag/AgCl electrodes
or carbon rubber electrodes
with sponges soaked with saline
solution can be used. The sponges
must be bigger than 3 mm2to
avoid high density currents.
WThe 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.
WThe device is wireless and might
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
has been tested using the 10-
wire or 12-wire 34 cm cables
provided with the system.
WThe 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.
WThe device cannot be used beside
or piled under other equipment.
If such usage is needed, check
the normal conguration.
WThe device can only be used in
healthy skin without wounds.
WThe device cannot be
used in a 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 to another device
connected to the patient, the user
should contact Neuroelectrics to
check the correct simultaneous use.
WStarstim 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.
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 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.
WKeep out of reach from children and
anyone else who might swallow
electrodes, otherwise they may
cause injury to themselves.
WKeep out of reach from children and
anyone else who might strangle
with the cables of the devices.
WThe result of the recordings must be
analysed by a doctor or specialist.
No self medication should be
done based on this results.
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.
WIf 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 specications 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
uFlexible electrode placement
based on the 10-10 system
uConduct mobile studies away
from the clinic or lab
uUser-friendly software interface
uStimulation waveforms:
tDCS, tACS and tRNS
uSham and double-blind modes
EEG monitoring and Stimulation *
uStimulation compatible with
simultaneous EEG monitoring
(not in the same site)
uStimulation and EEG monitoring are
possible at the same site with the
same electrode (not simultaneously)
uEEG monitoring is possible before,
during and after stimulation
IV.1
Features
EEG functionality *
uNumber of channels:
(up to) 8 channels
uSampling rate: 500 SPS
uBandwidth: 0 to 125
Hz (DC coupled)
uResolution: 24 bits - 0.05 µV
uMeasurement noise: < 1 µV RMS
uCommon mode rejection
ratio: -115 dB
uInput impedance: 1 GΩ
Stimulation functionality
uNumber of channels:
(up to) 8 channels
uSampling rate: 1000 SPS
uFrequency range: 0 to 250 Hz
(tACS) and 0 to 500 Hz (tRNS)
uStimulation types: linear
combination of tDCS, tACS
and tRNS; and Sham
uMaximum current per
channel: ± 2 mA
uCurrent resolution: 1 µA
uCurrent accuracy: 1%
uMaximum voltage: +- 15V
per electrode (allows 30 V of
stimulation potential difference)
Stimulation safety features
uMaximum input current
per channel: 2 mA
uMaximum total inject current: 4 mA
(by all electrodes, at any time)
uMaximum duration per
session: 1 hour
uStimulation session must
be pre-programmed
uElectrode impedance check
before and during stimulation
uAbort functionality possible
at any instant
IV.2
Technical Specications
*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 Specications
uBattery operating time:
8 hours (combined EEG/tCS use)
uAccelerometer: 3-axis
uCommunication:
NE001: Bluetooth® 3.0 and 2.1
NE001WF: Wi-Fi IEEE 802.11 b/g/n
uOutput: EDF+ (16 bits), ASCII data
files or TCP/IP raw data streaming
uOS compatibility: Windows (Vista
/ 7 / 8 /10) and MAC OS X
Minimum Computer Requirements
uOperating System: Windows Vista
or MAC OS X Snow Leopard
uProcessor: 1.3 GHz
uRAM: 2 GB
uBluetooth®: 2.1/Wi-Fi/USB
uNE001: Buetooth® 2.1 EDR
uNE001WF: Wi-Fi IEEE802.11g
Wireless Information
Starstim is a wireless device operating
at the 2.4GHz Industrial Medical and
Scientic (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 specications
regarding the Wireless connection
used by Necbox.
NE001 - Wireless Specifications
uBluetooth 3.0 and 2.1 Class 2
uOperating frequency band:
from 2.400 to 2483.5 MHz
uTransmitting power: Max. +3dBm
uQualifications: CE, FCC, IC,
Japan and South-Korea
uData rate: 921600 BPS
NE001WF- Wireless Specifications
uWi-Fi: IEEE 802-11 b/g/n
uOperating frequency band:
from 2.412 to 2472 MHz
uTransmitting power: Max. +16dBm
uQualifications: CE, FCC, IC,
Japan and South-Korea
uData rate: 921600 BPS
uSecurity details: Encryption WEB
IV.2
Technical Specications

19

20
The Neuroelectrics® Starstim 8 package contains all the
components required to perform an EEG monitoring or
stimulation session, and some additional items that may
be useful during your experiments. Once you have opened
the box, please conrm 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
1NE012 /
NE012WF Starstim 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
1NE019-M Neoprene Headcap M (54 cm)
8NE022 Electrode: Geltrode
8NE024 Electrode: Pistim
Quantity Code Name
50 NE025 Electrode: Sticktrode
4NE026a Electrode: Sponstim 25
4NE026b Electrode: Sponstim 8
1NE027 Electrode: Earclip
1NE031 /
NE031b
USB Bluetooth Dongle / USB Wi-Fi
Dongle
1NE033 Saline Solution 100 ml
1NE038 Testboard Head
1NE039 Testboard Cable
1NE043 USB Charging Cable (Bluetooth
devices)
1NE0164/
NE172
USB Cable & Isolator (Wi-Fi / USB
devices)