Soterix Medical 2001 Operator's Manual

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Soterix Medical 2001 Operator's Manual | Manualzz
Model 2001
1x1 Low-Intensity Transcranial Electrical Stimiulator (tES)
Operator’s Manual
No part of this manual may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic,
mechanical, photocopying, microfilming, recording, or otherwise, without written permission from Soterix Medical Inc.
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Version 2
July 2015
Copyright © 2012-2015, Soterix Medical Inc
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page ii
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
NOTICE
THE FOLLOWING MATERIAL IN THIS MANUAL IS EXCLUSIVELY FOR
INFORMATIONAL PURPOSES. THE CONTENT AND THE PRODUCT IT
DESCRIBES ARE SUBJECT TO CHANGE WITHOUT NOTICE. IN NO EVENT
WILL SOTERIX MEDICAL INC., BE LIABLE FOR THE DAMAGES ARISING
FROM OR RELATED TO THE USE OF THIS MANUAL OR THE PRODUCT IT
DESCRIBES.
Copyright © 2012-2015, Soterix Medical Inc
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page iii
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
CAUTION
As an ultimate user of this apparatus, you have the responsibility to
understand its proper function and operational characteristics. This
operator’s manual should be thoroughly read and all operators given
adequate training before attempting to place this unit in service.
Awareness of the stated cautions and warnings and compliance with
recommended operating parameters -- together with maintenance
requirements -- are important for safe and satisfactory operation. The
unit should be used for its intended application. Recommended
accessories should be used while using this system.
Copyright © 2012-2015, Soterix Medical Inc
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page iv
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
This page is left intentionally blank to provide an insertion place of any changes subsequent to
the printing of this document.
Copyright © 2012-2015, Soterix Medical Inc
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page v
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Contents
Page Title Page
iii.
Notice
iv.
Caution
vi.
Contents
Introduction
2.
Intended Use
4.
Getting to Know the Product
6.
Use of This Manual
Health and Safety
9.
Precautions and Warnings
12.
Regulatory Statements
Product Description
14.
Items Supplied
15.
Front Panel
16.
Back Panel
17.
Control Keys
Device Operation
20.
Inserting and Replacing the Batteries
22.
Description of Special Features
25.
Pre-Stimulation Setup
30.
Stimulation Procedure
Specifications and Warranty
34.
Electrical and Operating Characteristics
34.
Storage and Operating Conditions
35.
Warranty
35.
Soterix Medical Limited Warranty
36.
Obtaining Warranty Service
36.
Maintenance and Disposal
37.
Definition of Symbols Used
Further Information
40.
Bibliography
52.
Contact Information
Copyright © 2012-2015, Soterix Medical Inc
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page vi
1x1 tES Model 2001 Low-Intensity Stimulator
Introduction
Operator’s Manual
Intended Use - 2
Getting to Know the
Product - 4
Use of this Manual - 6
This chapter introduces you to the basics
required to use this manual fully as well as
operate the Soterix Medical 1x1 tES line of
stimulators.
Intended Use:
This section gives a description of the
process of transcranial Electrical Stimulation
and intended use.
Getting to Know the Product:
Read this section to learn what sets the
Soterix Medical 1x1 tES Low-Intensity
Stimulator apart from the rest.
Use of this Manual:
Refer to this section for information on how
this manual is organized as well as an
explanation of the symbols used throughout
the manual.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 1
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Intended Use
Transcranial Electrical Stimulation (tES) is a non-invasive procedure in
which a device sends a small current across the scalp to modulate brain
function. These currents generate an electrical field in the brain that
modulates brain function according to the modality of the application, which
can be direct (transcranial Direct Current Stimulation, tDCS), pulsed
(transcranial Pulsed Current Stimulation, tPCS), alternating (transcranial
Alternating Current Stimulation, tACS), random noise (transcranial Random
Noise Stimulation, tRNS), or oscillating direct (transcranial Oscillating Direct
Current Stimulation, tODCS). For tDCS, when this small current passes from
the positive electrode, anode to the negative electrode, cathode, it may
simultaneously increase the activity of the brain by the anode and decrease
the activity of the brain near the cathode. For tPCS, tACS, tRNS, electrode
polarity is not an issue as current reverses its direction at regular intervals.
tPCS, tACS and tRNS may interfere with ongoing neuronal oscillations and
may produce neuromodulatory effects similar to tDCS.
tES mechanisms are considered to result from the ability of very weak
currents to safely induce reversible changes in cortical plasticity. The
induction of lasting changes in cortical excitability can, under some
conditions, reversibly modify behavior and interact with normal learning.
Such findings have driven a large number of studies examining whether tES
might induce functionally significant changes in patients with a large variety
of neurological and psychiatric disorders.
tES dose can be defined as: 1) The size and position of the electrodes on
the body and 2) For tDCS and tODCS, the main determinants are intensity,
duration, and electrode polarity. While for tPCS, tACS, and tRNS, the main
determinants are intensity, duration, and frequency.
Soterix Medical tES systems allow precise reproduction of tES doses
commonly used in medical literature. Soterix Medical engineers and
scientists can work with you to determine the best configuration for your
application. Note: tES is an investigational technique and it is the
responsibility of the operator to determine the appropriate tES dose for a
particular application.
tES safety is supported by medical literature to have common side
effects limited to mild and reversible skin irritation, when using standard tES
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 2
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
protocols and guidelines. Soterix Medical tES stimulators and electrodes are
uniquely designed to minimize skin irritation – for example, the exclusive
SMARTscan–ESTM feature provides a simple indicator to the operator of the
contact conditions before, during, and after stimulation. Note: tES is an
investigational technique and it is the responsibility of the operator to identify
and follow the most appropriate safety protocols.
tES comfort can be controlled by the operator by using devices, such
as the Soterix Medical 1x1 tES Low-Intensity Stimulator, which are
specifically designed for clinical tES. For example, the unique PRE-STIM
TICKLE and RELAX features available on all Soterix Medical 1x1 models are
designed to condition the skin prior to stimulation and allow the operator to
accommodate subject feedback without stopping stimulation.
tES protocol, clinical results, and safety data can be better understood
by consulting the papers found in the bibliography at the end of this manual.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 3
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Getting to Know the Product
Thank you for purchasing a Soterix Medical 1x1 Low-Intensity Transcranial
Electrical Stimulator. Unlike other stimulators, the Soterix Medical 1x1 line of
stimulators is simple to use and designed especially for tES (tDCS, tPCS,
tACS, tRNS). In addition, a waveform polarity feature, allows operators to
generate unipolar waveforms or transcranial Oscillating Direct Current
Stimulation (tODCS). A unipolar wave causes the continuously changing
bipolar wave (for instance tPCS, tACS, and tRNS) to be DC offset, shifting it
into the positive territory.
The Soterix Medical 1x1 line of low-intensity tES stimulators is designed to
generate low levels of current between the electrodes placed on the body.
For direct current (tDCS) and oscillating direct current (tODCS), the anode is
the positive electrode from which current from the device enters the body,
while the cathode is the negative electrode from which current exits the body
and returns to the device. For bipolar pulsed current (tPCS), bipolar
alternating current (tACS), and bipolar random noise (tRNS) applications,
electrode polarity is not an issue as current reverses its direction at regular
intervals.
Provided Soterix Medical tES accessories allow for simple and comfortable
positioning of the electrodes on the body. The operator must set the
waveform desired (tDCS, tPCS, tACS, tRNS), frequency of stimulation (for
tDCS, O Hz is set automatically), duration of stimulation (in minutes),
intensity of current (in units of mA), active or sham setting, and finally
waveform polarity (unipolar setting generates oscillating direct current wave)
before initiating the stimulation. For waveform, duration and intensity
selection, there are four settings while for frequency, desired value can be
freely selected.
Clinicians and researchers choose the Soterix Medical 1x1 tES to:
1) Ensure reproducible and precise tES operation across subjects and time.
2) Provide for simple and comfortable tES set-up and stimulation.
3) Conduct clinical studies with state-of-the-art control and safety features.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 4
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
The Soterix Medical 1x1 tES line of stimulators includes several
proprietary features to enhance tES safety and subject comfort including
TRUE CURRENTTM, SMARTscan-ESTM, RELAX, and PRE-STIM TICKLE. By
reading this manual and understanding these unique features, operators of
the Soterix Medical 1x1 tES can enhance the efficacy and comfort of tES.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 5
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Use of This Manual
This manual contains details of installation, setup, and operation of the
Soterix Medical 1x1 tES unit and its accessories. This manual must be read
in its entirety before commencing any stimulation with the Soterix Medical
1x1 tES unit. If the instructions in this manual are not precisely followed, the
performance of this product and/or the safety of the user and/or patient may
be compromised. If you have any questions, comments, or concerns, please
contact Soterix Medical before starting use of the device.
The consequences that could result from failure to observe the precautions
listed in this section are indicated by the following symbol:
This icon marks warnings, information that should be read before
using this Soterix Medical product to prevent possible injury.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 6
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Classifications
In accordance with IEC 60601-1
- Internally powered equipment
-Type BF equipment.
-Continuous operation according to the mode of the operation.
-Portable equipment.
In accordance with EU Medical Device Directive
- Class IIa
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 7
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Precautions and
Warnings - 9
Health and Safety
Regulatory
Statements - 12
This chapter dictates the required
precautions for both you and your patient’s
safety.
Precautions and Warnings:
Read this section for the important list of
precautionary measures required to operate
this device.
Regulatory Statements:
This is where you will find the regulatory
statements for certain countries, which
determines how you may use this device
under federal law.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 8
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Precautions and Warnings
To prevent damage to your Soterix Medical product or injury to yourself or to
others, read the following safety precautions in their entirety before using
this equipment. Keep these safety instructions where all those who use the
product can easily access them.
Environment and Moisture
o Do not immerse the Soterix Medical 1x1 tES Low-Intensity
Stimulator in water or any other fluids.
o The Soterix Medical 1x1 tES Low-Intensity Stimulator should not
be used in a moist environment or if any parts of the stimulator
are damp or wet.
o The Soterix Medical 1x1 tES Low-Intensity Stimulator is not
certified for use in the presence of a flammable anesthetic
mixture with air or oxygen or nitrous oxide. The consequences of
using the Soterix Medical 1x1 tES Low-Intensity Stimulator near
flammable atmosphere are unknown.
o The Soterix Medical 1x1 tES Low-Intensity Stimulator is not
certified for use in an environment with strong magnetic fields
(including, but not limited to, MRI). The consequences of using
the Soterix Medical 1x1 tES Low-Intensity Stimulator in a strong
magnetic environment are unknown.
o Do not use any electronic device such as communication or
entertainment devices (i.e. GSM/CDMA cellular phones or
cordless phones, MP3 players) while the Soterix Medical 1x1
tES Low-Intensity Stimulator is being used. The consequences
of potential interference from communication and
entertainment devices on the Soterix Medical 1x1 tES LowIntensity Stimulator are unknown.
o Do not use the Soterix Medical 1x1 tES Low-Intensity Stimulator
if it was transported or stored at temperatures outside of the
specific range indicated in this manual. The consequences of
using the Soterix Medical 1x1 tES Low-Intensity Stimulator after
it is been transported or stored at temperatures outside of the
specific range are unknown.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 9
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
External Damage
o Do not drop the device.
o The Soterix Medical 1x1 tES Low-Intensity Stimulator should not
be used if there are any signs of external damage.
o Carefully inspect the device on arrival and prior to each use.
o If any controls or displays are not working as indicated in this
manual, do not use the Soterix Medical 1x1 tES Low-Intensity
Stimulator. Immediately return the device to Soterix Medical
Inc. for repair.
Cables
o When connecting cables to the output jacks, use only the
cables provided or sold by Soterix Medical Inc. to maintain
compliance with product regulations.
o Make sure all cables are fully inserted in the correct receivers
before operating the Soterix Medical 1x1 tES Low-Intensity
Stimulator.
Irritation
o Use only approved Soterix Medical Inc. EASYpadsTM indicated
for use with the Soterix Medical 1x1 tES Low-Intensity
Stimulator. Do not modify the EASYpadsTM. Do not reuse
EASYpadsTM that are indicated only for single use.
o The Soterix Medical 1x1 tES Low-Intensity Stimulator may cause
minor irritation, discomfort and redness at the electrode sites. If
irritation occurs, consult your clinician.
o Do not place the Soterix Medical 1x1 tES electrodes or sponges
over previously irritated, burnt, or damaged skin.
o Since sponge current density (injected current / sponge area)
has been shown to be an indicator of skin irritation, it is
recommended to use EASYpadsTM of size 5x5 cm and greater
for 2 mA current application. There is no single ―safe‖ current
density for all applications. It is the responsibility of the
operator to ensure the chosen current density is appropriate for
a given application prior to stimulation.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 10
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Internal Parts
o Do not disassemble. Touching the product’s internal parts could
result in injury. In the event of a malfunction, only a qualified
technician should repair the product from Soterix Medical Inc.
Should the product break open as the result of a fall or other
accident, remove the batteries and return the product to Soterix
Medical Inc. for repairs.
o No modification of the Soterix Medical 1x1 tES Low-Intensity
Stimulator is allowed.
Batteries
o Observe proper precautions when handling batteries. Be sure
the product is off before replacing batteries.
o Use only batteries approved for use in this equipment. Do not
attempt to insert batteries upside down or backwards.
Electronic Monitoring
o Electronic monitoring equipment (such as ECG monitors, ECG
alarms) may not operate properly when tES stimulation is in
use.
Technique
o The Soterix Medical 1x1 tES Low-Intensity Stimulator must only
be used with appropriate supervision and by a trained operator.
Even experienced operators must carefully read and fully follow
all the following instructions and guidelines.
o Presence of pacemaker and metal implant are usually
considered contraindications. History of seizure, Traumatic
Brain Injury, history of stroke, are usually not strict
contraindications and might be inclusion criteria in some trials.
To-date there have been no published studies in pregnant
women. The safety of electrical stimulation during pregnancy
has not been established.
o All operators must ensure that Soterix Medical 1x1 tES LowIntensity Stimulator is applied within local and federal or
country guidelines as relevant.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 11
1x1 tES Model 2001 Low-Intensity Stimulator
o
Operator’s Manual
The Soterix Medical 1x1 Low-Intensity Stimulator should not be
used in combination with any other implanted or external
electrical stimulation device.
Regulatory Statements
Transcranial Electrical Stimulation (tES) is an investigational technique. It is
limited by Federal law to investigational use under appropriate Institutional
Review Board guidelines.
USA:
CAUTION:
The Soterix Medical 1x1 Low Intensity transcranial Electrical
Stimulator is an investigational device. Federal (or United
States) law limits device to investigational use.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 12
1x1 tES Model 2001 Low-Intensity Stimulator
Product Description
Operator’s Manual
Items Supplied - 14
Front Panel - 15
Back Panel - 16
Control Keys - 17
This chapter is comprised of the following sections:
Items Supplied:
This section gives a checklist of the items that are
found in every package sent out with the 1x1 tES
Low-Intensity Stimulator as well as any items that
could be sent out additionally to the standard
package.
Front Panel:
This section contains an illustration of the front
panel with every button labeled numerically.
Back Panel:
This section contains an illustration of the rear
panel with every button labeled numerically.
Control Keys:
Basic description of all the controls and display
functions indicated in the previous two sections.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 13
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Items Supplied
1 Soterix Medical 1x1 Low-Intensity Transcranial Electrical Stimulator
5 pairs Soterix Medical EASYpadTM sponges with 2 carbon-rubber
electrode insets. EASYpadTM sponges are rated for one-time use only.
1 Red anode cable
1 Black cathode cable
Elastic fasteners (one long, one short) with 2 plastic joints.
Items Supplied Separately
100 Replacement Soterix Medical EASYpadsTM
Standard EASYpadsTM sizes 3x5cm, 5x5cm, 5x7cm, 5x10cm.
(Customizable EASYpadsTM sizes available upon customer request )
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 14
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Front Panel
2
1
4
3
6
7
8
5
12
13
14
9
15
10
16
11
17
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 15
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Back Panel
18
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
19
Page 16
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Control Keys
1. A display, which indicates the amount of time remaining in the
stimulation.
2. A display, which indicates the frequency of waveform.
3. A display which indicates how ―good‖ the contact quality of the leads
are.
4. A switch, which modulates the intensity of the current value being
produced by the device.
5. A display that indicates the amount of current being produced by the
device.
6. Adjusts the frequency of the waveform (0 - 200 Hz) prior to the start of
stimulation.
7. Adjusts the desired waveform (tDCS, tPCS, tACS, tRNS) prior to the
start of stimulation
8. Starts the PRE-STIM TICKLE.
9. Indicates if there is low battery by illuminating red.
10. Turns on or off the device.
11. Adjusts the duration of the stimulation (10, 20, 30, or 40 minutes)
prior to the start of stimulation.
12. Activates or deactivates SHAM.
13. Indicates current ramp (up or down) by flashing green. Indicates steady
current by steady green.
14. Starts the stimulation.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 17
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
15. Allows setting waveform polarity (unipolar, bipolar) prior to the start of
stimulation.
16. Stops the stimulation.
17. Adjusts the intensity of the waveform (1, 1.5, 1.75, or 2 mA) prior to the
start of stimulation.
18. The connector for the anode cable.
19. The connector for the cathode cable.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 18
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Inserting and Replacing
the Batteries - 20
Device Operation
Description of Special
Features - 22
Pre-Stimulation
Setup - 25
Stimulation
Procedure - 30
This chapter outlines the steps needed to operate
your Soterix Medical 1x1 tES Low-Intensity
Stimulator
Inserting and Replacing the Batteries:
This section explains how you must insert the
batteries into the device. It also explains how to
replace them and when it is required.
Description of Special Features:
This section gives an in-depth description of all the
special features that come with your purchase of
this Soterix Medical 1x1 tES Stimulator device.
Pre-Stimulation Setup
Here you are provided with information about the
first steps you must take to prepare the device and
subject prior to stimulation.
Stimulation Procedure
This section contains the procedure for the tES.
Additionally it gives a list of what the operator must
do and provides information about what the device
does during stimulation.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 19
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Inserting and Replacing the Batteries
The 1x1 tES Low-Intensity Stimulator operates on two 9V alkaline batteries.
Duracell is recommended for use.
To insert the batteries, flip the device to its back and
remove the battery cover. Correct battery polarity is
indicated inside the battery cover (right). The positive
connectors should be toward the outside edges of the
device.
Then, insert the two batteries, one at a time, ensuring
proper battery orientation for each battery (below).
After the batteries are in place, replace the battery compartment lid by
sliding the lid back into its place and pressing it down until it ―snaps‖ into
place. Immediately after battery insertion, power up the 1x1 tES LowIntensity Stimulator to ensure correct battery placement. If the 1x1 tES LowIntensity Stimulator does not power up, check that the batteries are good
and inserted correctly.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 20
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Note: Batteries should be removed from the 1x1 tES LowIntensity Stimulator if it is not likely to be used for an
extended period of time.
Please observe the proper direction of the battery’s polarity
as indicated by the stickers inside of the battery
compartment. When facing the back of the device, both the
positive connectors must be toward the outside of the device
and both the negative connectors toward the inside.
Batteries should be replaced every 3 hours of use or when the low battery
indicator is illuminated. Do not use abrasive cleaners on the battery contacts.
To replace the batteries, first remove the old batteries by removing the
bottom of the battery first. Take out the batteries one-at-a-time. Then insert
the new batteries.
Dispose of depleted batteries in accordance with local
regulations.
Note: When the device is not in use, turn the power off to save
battery life.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 21
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Description of Special Features
TRUE CURRENTTM: The TRUE CURRENTTM display is active whenever the
device is on. For tDCS, TRUE CURRENTTM always indicates the actual value of
current (in mA) being supplied by the device to the electrodes – regardless of
device settings. For waveforms with frequency content (tPCS, tACS and
toDCS), TRUE CURRENTTM indicates the maximum value the waveform is able
to reach. The TRUE CURRENTTM feature is disabled for tRNS as current
intensity values are randomly generated. Thus for all waveforms aside of
tRNS, TRUE CURRENTTM functions as a fully independent and redundant
safety feature when monitored by the operator.
Note: It is recommended the TRUE CURRENTTM be monitored
for the entire duration of stimulation.
SMARTscan-ESTM: The SMARTscan-ES TM feature provides a constant display
of electrode contact quality before, during, and after stimulation. There is no
―best‖ SMARTscan-ES TM level that applies to every tES configuration. With
experience, operators can determine ideal, tolerable, and cautionary levels.
The SMARTscan-ESTM indication is provided by a 10 bar LED display (1 to 10
from left to right). LED 1 denotes short condition and LED 2 denotes opencircuit condition. Do not stimulate if either LED 1 or LED 2 is lit. The
SMARTscan-ESTM indication is not available during stimulation for tRNS.
Since contact quality is determined by measuring the voltage drop from
injected current values, generation of random current values in tRNS makes
reliable contact quality measurement impractical.
SMARTscan-ESTM is a feature intended to assist in the set-up
and operation of tES. It is not intended to substitute or
replace operator judgment and protocol. Each set-up and
operation should be independently monitored and verified by
a trained operator following best tES protocols. Any issues or
concerns identified by the operator should be addressed
regardless of the SMARTscan-ESTM reading.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 22
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Stimulation ABORT: At any point during stimulation, the operator may
terminate the stimulation by pressing the ABORT button. The operator is
responsible for determining when aborting the stimulation is appropriate. It is
recommended to hit ABORT if TRUE CURRENT deviates from expected output
current and/or TIME REMAINING deviates from expected duration setting.
Note: Pressing ABORT will ramp down the current to zero and
terminate the entire stimulation run.
RELAX: At any point during stimulation, the operator may use the RELAX
slider to decrease the set level of current from the maximum (FULL
CURRENT) value. TRUE CURRENTTM will indicate the reduced current value.
Adjusting the RELAX amount will have no effect on the duration of
stimulation. The operator is responsible for determining when to use the
RELAX feature, for example, based on a subject’s discomfort level. It is
important that the RELAX amount is decreased and increased slowly, to
avoid any sudden current changes.
RELAX
feature is
disengaged.
Full set
current
supplied
RELAX
feature is
engaged. Set
current is
reduced as
slider is
lowered
With RELAX
slider fully
lowered,
minimal
current is
supplied.
Note: The
current
does not
reduce to
zero.
Rapid changes in current level, either decreasing or
increasing, should be minimized. When using the RELAX
feature, always monitor the TRUE CURRENT TM display and
adjust slider gradually.
PRE-STIM TICKLE: When the device is turned on and after the electrodes are
placed on the subject, but before stimulation is initiated, the PRE-STIM
TICKLE button may be pressed to activate an approximately 30 second, 1 mA
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1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
current. The PRE-STIM waveform is determined by the waveform selected by
the WAVEFORM SELECTOR switch. During PRE-STIM TICKLE, the TIME
REMAINING display will indicate ―Pr‖. The TRUE CURRENTTM display will
indicate the current being delivered for all waveform options available (tDCS,
tPCS, tACS) aside of tRNS, where current intensity values are randomly
generated.
The operator is responsible for determining when it is appropriate to use
PRE-STIM TICKLE, for example, to condition the electrodes, skin, or the
subject. Pressing the PRE-STIM TICKLE button during stimulation will have no
effect.
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1x1 tES Model 2001 Low-Intensity Stimulator
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Pre-Stimulation Setup
1) Turn the POWER switch ON. The TRUE CURRENTTM display will illuminate
and indicate 00.00 mA. The SMARTscanTM display will illuminate indicating a
low quality. The FREQUENCY display will either indicate 000.0 Hz or 050.0 Hz
depending on the WAVEFORM SELECTOR setting selected on device (50 Hz is
the default setting for non-DC waveforms)
When the subject is connected to the device, turning the
power on or off is not recommended.
2) If LOW BATTERY is illuminated, do not proceed with stimulation. Replace
both batteries with new batteries. Make sure both batteries are inserted in
the correct polarity, as indicated inside the battery compartment.
3) Connect the provided cables to the device using the banana plugs on the
back of the device. To attach the cables, take the long plastic end and insert
it into the similarly colored receiver. The red wire must be inserted into the
red receiver labeled ―anode‖ and the black wire inserted into the grey
receiver labeled ―cathode‖ (below).
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1x1 tES Model 2001 Low-Intensity Stimulator
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4) Clean the surface of the skin to remove
any signs of lotion, dirt, etc. and allow it to
dry. Inspect the rubber insets and
sponges for wear. If there is any evidence
of deterioration, throw out the dirty
components and use a new electrode.
5) Insert the connector cord pin securely
into the opening of the receptacle on the
rubber inset. (right)
6) Each side of the sponge should be soaked with saline solution. For a
35 cm2 sponge, approximately 6 mL of saline (total of 12 mL per sponge)
may suffice. Be careful not to over soak the sponge. Avoid fluid leaking
across the subject.
7) Then slide the rubber inset fully into the sponge EASYpadsTM (5x7 cm
EASYpadsTM shown below).
8) Use only appropriate accessories to fix the sponge to the subject including
Soterix Medical elastic fasteners or EASYstrapsTM. Apply the electrodes to the
treatment site by firmly pressing down the center of the pad and then
smoothing down towards the electrode edges. Verify there is a smooth and
even contact with the skin and ensure that the rubber insert does not
contact the skin.
Note: Both sponges must remain evenly moist across the
entire surface for the duration of the procedure.
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1x1 tES Model 2001 Low-Intensity Stimulator
.
Operator’s Manual
Electrode sponges should remain moist across the entire
surface for the duration of stimulation. If the sponges are dry,
do not start stimulation. If any irritation or discomfort occurs,
discontinue use and consult a clinician
9) The SMARTscan-ESTM contact quality meter will now indicate the quality of
the electrode contact. There is no single ―best‖ reading for all applications;
however; generally a higher quality reading indicates a ―better‖ electrodeskin contact (the right most bar on the 10 bar LED display indicates the best
display). It is the responsibility of the operator to ensure that the SMARTscanESTM quality reading is appropriate for a given application prior to stimulation.
If the quality reading is not in the desired range, adjust one or both of the
electrode contacts The SMARTscan-ES TM will constantly update showing the
current electrode quality during adjustments.
10) Once the SMARTscan-ESTM reading is in the desired range, set the
WAVEFORM SELECTOR to the desired waveform, set FREQUENCY to the
desired frequency value (in Hz), set DURATION to the desired duration value
(in minutes), and set CURRENT INTENSITY to the desired current value (in
mA). The FREQUENCY display will constantly update showing the chosen
frequency value during adjustments.
For tODCS, set the POLARITY switch to unipolar. A unipolar wave causes the
continuously changing bipolar waves (tPCS, tACS, and tRNS) to be DC offset,
shifting it into the positive territory.
It is the responsibility of the operator to ensure that the current, duration,
frequency, polarity, and waveform settings are appropriate and safe for the
application.
Note: The duration value does not include an approximately
30 second ramp up time at the start of stimulation and
an approximately 30 second ramp down time at the end
of stimulation. Active tDCS (or SHAM OFF) waveform is
shown below.
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1x1 tES Model 2001 Low-Intensity Stimulator
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Intensity
Ramp up
(~30 seconds)
Duration
Ramp down
(~30 seconds)
Figure 1: Active tDCS waveform
Figure 2: Active tPCS waveform (left). Active tACS waveform (middle). Active tRNS waveform
(right). All waveforms depicted are bipolar.
Figure 3: Active tODCS waveforms. tODCS is generated from unipolar versions of Figure 2:
Pulsed (left), Sine (middle), and Random Noise (right).
For any of the waveforms selected, current ramps up in 30 seconds,
stimulates for the duration selected via the DURATION knob and ramps-down
in 30 seconds.
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11) Select either SHAM ON or OFF using the switch. (SHAM ON waveform
shown below for tDCS)
Ramp up
(~30 seconds)
Duration
Ramp down
(~30 seconds)
Intensity
Figure 4: Sham tDCS waveform
Similarly for other waveforms (tPCS, tACS ,tRNS, tODCS), current ramps up to
set INTENSITY in 30 seconds and ramps down in 30 seconds. There is no
stimulation in the interim and current ramp up and ramp down is repeated at
the end of stimulation.
12) Ensure the RELAX slider is set to FULL CURRENT (right).
13) Now would be the time to activate the PRE-STIM TICKLE if desired. To do
so, press the PRE-STIM TICKLE button (below). It is the responsibility of the
operator to determine if it is appropriate to use the PRESTIM TICKLE.
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1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Stimulation Procedure
1) Confirm that the WAVEFORM, FREQUENCY, DURATION, INTENSITY, and
POLARITY are set to the desired values, SHAM is set to its desired setting,
and the RELAX slider is set to full current.
2) Start the stimulation by pressing the START button
(right)
Note: Once the START button is pressed and tES
begins,
changing
the
waveform,
frequency, duration, intensity, and
polarity knobs will have no effect on the
ongoing stimulation. These knobs are to
be set before the start of the stimulation to allow for
proper tES.
3) The stimulation ACTIVE light will first flash for a period of approximately
30 seconds while the current is ramping up. The TRUE CURRENTTM display
will show the current ramping up to the set INTENSITY value. For waveforms
with frequency content (tPCS, tACS and toDCS), TRUE CURRENTTM indicates
the maximum value the waveform is able to reach. The TRUE CURRENT TM
feature is disabled for tRNS, as current intensity values are randomly
generated.
4) Once the ramp up is complete, the stimulation ACTIVE light will stop
flashing and remain illuminated. The TIME REMAINING display will now
indicate the time remaining in the stimulation session. The value will start at
the time selected in DURATION and count down. The value will initially show
the amount of minutes remaining.
5) The TRUE CURRENTTM display constantly shows the current delivered to
the subject. The operator should monitor this display. If there is any
deviation from the expected current, as set by the operator and described in
this manual, stimulation should be aborted.
6) The SMARTscan-ESTM feature indicates contact quality during stimulation.
The operator should monitor this display during stimulation. It is typical for
electrode quality to decrease during stimulation, while an increase may
indicate a problem with the electrodes. The stimulator will not automatically
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1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
shut down during stimulation. It is the responsibility of the operator to
ensure that the SMARTscan-ES TM quality reading is appropriate for a given
application during stimulation. Note that the SMARTscan ESTM indication is
not available during stimulation for tRNS.
During tES, tampering with the placement of the sponges is
not recommended.
7) The RELAX feature can be used at any point during the stimulation. It is
used to accommodate individual subject’s sensation by moving the RELAX
slider down away from FULL CURRENT. The current supplied by the device
will decrease to the value shown in the TRUE CURRENT TM DISPLAY which can
be monitored.
8) When there is 1 minute remaining in the stimulation, the TIME
REMAINING display will switch to seconds. It will count down the final 60
seconds. This will be indicated by the illumination of the light adjacent to
―Sec‖ below the TIME REMAINING display.
9) When the TIME REMAINING reaches zero, the display will turn off and the
current will ramp down for approximately 30 seconds. During the ramp
down, the stimulation ACTIVE light will flash.
10) Once the ramp down is complete, the stimulation ACTIVE light will turn
off.
11) tES is now complete.
12) Disconnect the electrodes from the subject.
13) Turn the POWER switch OFF.
Note: If during the course of stimulation, it is desired to stop
the stimulation manually, it is recommended that the
ABORT feature be used instead of the power being
switched off.
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1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
When the subject is connected to the device, turning the
power on or off is not recommended.
Please use Soterix Medical 1x1 tES Low-Intensity Stimulator
only as directed by this document. Failure to do so might result
in an unexpected outcome. Do not modify the equipment
without prior authorization of the manufacturer.
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1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Specifications -- 34
Warranty — 35
Specifications, Warranty
and Definition of Symbols
Used
Maintenance and
Disposal — 36
Definition of Symbols
Used — 37
This chapter is comprised of the following sections:
Specifications:
This section contains a list of the details of the
device specification.
Warranty:
Here is the Limited Warranty. It dictates under
what circumstances your 1x1 Transcranial
Electrical Low-Intensity Stimulator is repaired free
of charge. It also explains how to obtain your
warranty service.
Maintenance and Disposal:
This sections lists instructions for continued safeuse and disposal
Definitions and Symbols Used:
This sections lists definitions of the symbols used.
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1x1 tES Model 2001 Low-Intensity Stimulator
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Specifications
Electrical and Operating Characteristics
Power source: 2, 9V Alkaline batteries
Battery life (with fresh batteries): 3 hrs**
5 standard modes –DC (tDCS and tODCS) and non-DC (tPCS, tACS, tRNS)
Adjustable frequencies up to 200 Hz with 0.5 Hz resolution
Adjustable duration up to 40 minutes
Adjustable current intensity up to ±2,000 µA
Length: 7.91 in.
Width: 5.9 in.
Height: 2.83 in.
Connector type: shielded banana
Maximum Output Voltage: 40V ± 2V
Storage and Operating Conditions
Parameter
Minimum temperature
Maximum temperature
Minimum humidity
Maximum humidity
Minimum atmospheric
pressure
Maximum atmospheric
pressure
*All
**
Storage
50° F
110° F
20%
90%
20.7 in. Hg (700 hPa)
Operating
50° F
110° F
20%
90%
20.7 in. Hg (700 hPa)
31.3 in. Hg (1060 hPa)
31.3 in. Hg (1060 hPa)
measurements are approximated
Test perform with 2x9V Alkaline Duracell Battery
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1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Warranty
Soterix Medical Limited Warranty
A.
B.
C.
This Limited Warranty provides the following assurance to the first purchaser
of the Soterix Medical Inc. 1x1 tES Low-Intensity Stimulator Model 2001,
hereafter referred to as “Equipment”:
(1) Should the Equipment fail to function within normal tolerances due
to a defect in materials or workmanship within a period of one (1)
year, commencing with the delivery of the Equipment to the
purchaser, Soterix Medical will at its option: (a) repair or replace
any part or parts of the Equipment; (b) issue a credit to the purchaser
equal to the Purchase Price against the purchase of the replacement
Equipment or (c) provide a functionally comparable replacement
Equipment at no charge. The Equipment must be returned to Soterix
Medical Inc., carriage paid and insured, in the most appropriate
method as determined by Soterix Medical Inc.
(2) As used herein, Purchase Price shall mean the lesser of the net
invoiced price of the original, or current functionally comparable, or
replacement Equipment.
To qualify for Limited Warranty set forth in Section A (1), the following
conditions must be met:
(1) The Equipment must be returned to Soterix Medical within thirty
(30) days after discovery of the defect, (Soterix Medical may, at its
option, repair the Equipment on site).
(2) The Equipment must not have been repaired or altered outside of
Soterix Medical’s factory in any way, which, in the judgment of
Soterix Medical, affects its stability and reliability. The Equipment
must not have been subjected to misuse, abuse, or accident. This
warranty does not apply to any exterior appearance item of the
Equipment which has been damaged or defaced, which has been
subject to misuse and abuse, abnormal service or handling, or which
has been altered or modified in design or construction.
(3) This warranty does not apply to any interconnection cables supplied
with the Equipment.
This Limited Warranty is limited to its expressed terms. In particular:
(1) Except as expressly provided by this Limited Warranty, SOTERIX
MEDICAL IS NOT RESPONSIBLE FOR ANY DIRECT,
INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED ON
ANY DEFECT FAILURE OR MALFUNCTION OF THE
EQUIPMENT, WHETHER THE CLAIM IS BASED ON
WARRANTY, CONTRACT, TORT, OR OTHERWISE.
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1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
(2) This Limited Warranty is made only to the purchaser of the
Equipment. AS TO ALL OTHERS, SOTERIX MEDICAL INC.
MAKES NO WARRANTY, EXPRESS OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE WHETHER ARISING FROM
STATUTE, COMMON LAW, CUSTOM, OR OTHERWISE. NO
EXPRESS OR IMPLIED WARRANTY TO THE PATIENT
SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1)
ABOVE, THIS LIMITED WARRANTY SHALL BE THE
EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.
(3) The exclusions and limitations set out above are not intended to, and
should not be construed so as to contravene mandatory provisions of
applicable law. If any part or term of this Limited Warranty is held to
be illegal, unenforceable, or in conflict with applicable law by a court
of competent jurisdiction, the validity of the remaining portions of
the Limited Warranty shall not be affected, and all rights and
obligations shall be construed and enforced as if this Limited
Warranty did not contain the particular part or term held to be
invalid. This Limited Warranty gives the purchaser specific legal
rights. The purchaser may also have other rights, which vary within
specific regions.
(4) No person has any authority to bind Soterix Medical Inc. to any
representation, condition, or warranty except this Limited Warranty.
Obtaining Warranty Service
Warranty service of this Equipment can be obtained by returning the
Equipment, carriage paid and insured, to Soterix Medical. Prior authorization
before shipping the product is advised for the most expedient service.
Maintenance and Disposal
For continued safe use and disposal of Soterix Medical 1x1 LowIntensity Stimulator, read the following instructions.
o
The Soterix Medical 1x1 tES Low-Intensity Stimulator must be
stored away from fluids and heat sources.
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1x1 tES Model 2001 Low-Intensity Stimulator
o
o
o
o
o
o
o
Operator’s Manual
To clean the Soterix Medical 1x1 tES Low-Intensity Stimulator,
use a dry cloth to wipe dust from the external surface when
necessary. Do not spray liquid cleaners directly on the Soterix
Medical 1x1 tES Low-Intensity Stimulator, as this will void your
warranty.
Do not disinfect the Soterix Medical 1x1 tES Low-Intensity
Stimulator
Return the device to Soterix Medical for disposal when the
device is no longer required.
Do not throw the Soterix Medical 1x1 tES Low-Intensity
Stimulator in generic waste.
Discharged batteries must be disposed appropriately in
accordance with national regulations in force.
Output cables, carbon-rubber insets, and elastic fasteners can
be disposed in generic waste when no longer required.
EASYpads sponges are rated for one-time use only and can be
disposed in generic waste after use.
Definition of Symbols Used
Type BF protection against electric shock. Isolated
(floating) applied part suitable for intentional
application to the subject, excluding direct cardiac
application
Refer to instruction manual/booklet
Fragile. Handle with care
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1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Keep Dry. Protect from Water.
Device runs on DC current.
4 3 oC
Operate between 10°C – 43°C (50°F – 110°F)
1 0 oC
SN
Serial Number
Address of manufacturer
Do not re-use
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1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Bibliography — 40
Further Information
Contact Information —
52
In this chapter, you can find:
Bibliography:
Here is a selection of peer-reviewed articles that
Soterix Medical has found to be relevant to tES
practices.
Contact Information:
This section houses a list of all the ways Soterix
Medical can be contacted.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
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Page 39
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Bibliography
The following bibliography includes a selection of peer-reviewed publications.
This is not a comprehensive list of all tES studies, but includes a
representative list as of the date of the publication of this manual. The
inclusion of these reports in this bibliography does not in any way imply an
endorsement of the protocol or results reported in these studies by Soterix
Medical. It remains the responsibility of the device user to remain informed
of all current, relevant tES practices. Note: tDCS is an investigational medical
technique and has not been cleared by the FDA and therefore can only be
used for research under appropriate Institutional Review Board guidelines.
1.
2.
3.
4.
5.
6.
7.
8.
Antal A, Brepohl N, Poreisz C, Boros K, Csifcsak G, Paulus W.
Transcranial direct current stimulation over somatosensory cortex
decreases experimentally induced acute pain perception. Clin J
Pain. 2008;24(1):56-63
Antal A, Nitsche MA, Kruse W, Hoffmann K-P, Paulus W: Visuomotor
coordination is improved by transcranial direct current stimulation
of the human visual cortex. J Cog Neurosci 2004;16:521-527
Antal A, Nitsche MA, Paulus W. Transcranial direct current
stimulation and the visual cortex. Brain Res Bull. 2006;68(6):45963.
Antal A, Paulus W. Transcranial direct current stimulation and visual
perception. Perception. 2008;37(3):367-74
Arul-Anandam AP & Loo CK. Transcranial direct current stimulation:
a new tool for the treatment of depression? Journal of Affective
Disorders 2009; 117 (3): 137-145.
Arul-Anandam AP, Loo CK, Mitchell P. Induction of hypomanic
episode with transcranial direct current stimulation. Journal of ECT
2010; 26:68-69
Arul-Anandam AP, Loo CK, Martin D, Mitchell PB. Chronic
neuropathic pain alleviation after transcranial direct current
stimulation to the dorsolateral prefrontal cortex; Brain Stimulation
(2009) 2, 149–51
Boggio PS, Castro LO, Savagim EA, Braite R, Cruz VC, Rocha RR,
Rigonatti SP, Silva MT, Fregni F. Enhancement of non-dominant
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 40
1x1 tES Model 2001 Low-Intensity Stimulator
9.
10.
11.
12.
13.
14.
15.
16.
17.
Operator’s Manual
hand motor function by anodal transcranial direct current
stimulation. Neurosci Lett. 2006;404(1-2):232-6.
Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, PascualLeone A, Fregni F. Effects of transcranial direct current stimulation
on working memory in patients with Parkinson's disease. J Neurol
Sci. 2006;249(1):31-8.
Boggio PS, Khoury LP, Martins DC, Martins OE, de Macedo EC,
Fregni F. Temporal cortex direct current stimulation enhances
performance on a visual recognition memory task in Alzheimer
disease. J Neurol Neurosurg Psychiatry. 2009;80(4):444-7.
Boggio PS, Nunes A, Rigonatti SP, Nitsche MA, Pascual-Leone A,
Fregni F. Repeated sessions of noninvasive brain DC stimulation is
associated with motor function improvement in stroke patients.
Restor Neurol Neurosci. 2007;25(2):123-9.
Boggio PS, Rocha RR, da Silva MT, Fregni F. Differential modulatory
effects of transcranial direct current stimulation on a facial
expression go-no-go task in males and females. Neurosci Lett.
2008;447(2-3):101-5.
Boggio PS, Rigonatti SP, Ribeiro RB, Myczkowski ML, Nitsche MA,
Pascual-Leone A, Fregni F. A randomized, double-blind clinical trial
on the efficacy of cortical direct current stimulation for the
treatment of major depression. Int J Neuropsychopharmacol.
2008;11(2):249-54.
Boggio PS, Sultani N, Fecteau S, Merabet L, Mecca T, Pascual-Leone
A, Basaglia A, Fregni F. Prefrontal cortex modulation using
transcranial DC stimulation reduces alcohol craving: a double-blind,
sham-controlled study. Drug Alcohol Depend. 2008;92(1-3):55-60.
Boggio PS, Zaghi S, Fregni F. Modulation of emotions associated
with images of human pain using anodal transcranial direct current
stimulation (tDCS). Neuropsychologia. 2009;47(1):212-7.
Boggio PS, Zaghi S, Lopes M, Fregni F. Modulatory effects of anodal
transcranial direct current stimulation on perception and pain
thresholds in healthy volunteers. Eur J Neurol. 2008;15(10):112430.
Boggio PS, Ferrucci R, Mameli F, Martins D, Martins O, Vergari M,
Tadini L, Scarpini E, Fregni F, Priori A. Prolonged visual memory
enhancement after direct current stimulation in Alzheimer's disease.
Brain Stimul. 2011 Jul 27.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 41
1x1 tES Model 2001 Low-Intensity Stimulator
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
Operator’s Manual
Bolognini N, Pascual-Leone A, Fregni F. Using non-invasive brain
stimulation to augment motor training-induced plasticity. J
Neuroeng Rehabil. 2009;6:8.
Bolognini N, Vallar G, Casati C, Latif LA, El-Nazer R, Williams J,
Banco E, Macea DD, Tesio L, Chessa C, Fregni F. Neurophysiological
and behavioral effects of tDCS combined with constraint-induced
movement therapy in poststroke patients. Neurorehabil Neural
Repair. 2011 Nov-Dec;25(9):819-29.
Borckardt JJ, Bikson M, Frohman H, Reeves ST, Datta A, Bansal V,
Madan A, Barth K, George MS. A Pilot Study of the Tolerability and
Effects of High-Definition Transcranial Direct Current Stimulation
(HD-tDCS) on Pain Perception. J Pain. 2011 Nov 18.
Boros K, Poreisz C, Münchau A, Paulus W, Nitsche MA. Premotor
transcranial direct current stimulation (tDCS) affects primary motor
excitability in humans. Eur J Neurosci. 2008;27(5):1292-300.
Brunoni AR, Valiengo L, Zanao T, de Oliveira JF, Bensenor IM, Fregni
F. Manic psychosis after sertraline and transcranial direct-current
stimulation.
J
Neuropsychiatry
Clin
Neurosci.
2011
Summer;23(3):E4-5.
Brunoni AR, Fregni F, Pagano RL. Translational research in
transcranial direct current stimulation (tDCS): a systematic review of
studies in animals. Rev Neurosci. 2011;22(4):471-81. Review.
Chadaide Z, Arlt S, Antal A, Nitsche MA, Lang N, Paulus W.
Transcranial direct current stimulation reveals inhibitory deficiency
in migraine. Cephalalgia. 2007;27(7):833-9.
Cogiamanian F, Marceglia S, Ardolino G, Barbieri S, Priori A.
Improved isometric force endurance after transcranial direct current
stimulation over the human motor cortical areas. Eur J Neurosci.
2007;26(1):242-9.
Csifcsak G, Antal A, Hillers F, Levold M, Bachmann CG, Happe S,
Nitsche MA, Ellrich J, Paulus W. Modulatory effects of transcranial
direct current stimulation on laser-evoked potentials. Pain Med.
2009;10(1):122-32.
Datta A, Baker JM, Bikson M, Fridriksson J. Individualized model
predicts brain current flow during transcranial direct-current
stimulation treatment in responsive stroke patient. Brain Stimul.
2011 Jul;4(3):169-74.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 42
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28.
29.
30.
31.
32.
33.
34.
35.
36.
Operator’s Manual
Edwards DJ, Krebs HI, Rykman A, Zipse J, Thickbroom GW,
Mastaglia FL, Pascual-Leone A, Volpe BT. Raised corticomotor
excitability of M1 forearm area following anodal tDCS is sustained
during robotic wrist therapy in chronic stroke. Restor Neurol
Neurosci. 2009;27(3):199-207.
Elmer S, Burkard M, Renz B, Meyer M, Jancke L. Direct current
induced short-term modulation of the left dorsolateral prefrontal
cortex while learning auditory presented nouns. Behav Brain Funct.
2009;5(1):29.
Faber M, Vanneste S, Fregni F, De Ridder D. Top down prefrontal
affective modulation of tinnitus with multiple sessions of tDCS of
dorsolateral prefrontal cortex. Brain Stimul. 2011 Oct 5.
Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia
S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct
current stimulation improves recognition memory in Alzheimer
disease. Neurology. 2008;71(7):493-8.
Ferrucci R, Marceglia S, Vergari M, Cogiamanian F, Mrakic-Sposta S,
Mameli F, Zago S, Barbieri S, Priori A. Cerebellar transcranial direct
current stimulation impairs the practice-dependent proficiency
increase in working memory. J Cogn Neurosci. 2008;20(9):1687-97.
Fecteau S, Knoch D, Fregni F, Sultani N, Boggio P, Pascual-Leone A.
Diminishing risk-taking behavior by modulating activity in the
prefrontal cortex: a direct current stimulation study. J Neurosci.
2007;27(46):12500-5.
Fecteau S, Pascual-Leone A, Zald DH, Liguori P, Théoret H, Boggio
PS, Fregni F. Activation of prefrontal cortex by transcranial direct
current stimulation reduces appetite for risk during ambiguous
decision making. J Neurosci. 2007;27(23):6212-8.
Frank E, Schecklmann M, Landgrebe M, Burger J, Kreuzer P, Poeppl
TB, Kleinjung T, Hajak G, Langguth B. Treatment of chronic tinnitus
with repeated sessions of prefrontal transcranial direct current
stimulation: outcomes from an open-label pilot study. J Neurol.
2011;
Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP,
Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA,
Pascual-Leone A. A sham-controlled, phase II trial of transcranial
direct current stimulation for the treatment of central pain in
traumatic spinal cord injury. Pain. 2006;122(1-2):197-209.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
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37.
38.
39.
40.
41.
42.
43.
44.
45.
Operator’s Manual
Fregni F, Boggio PS, Mansur CG, Wagner T, Ferreira MJL, Lima M,
Rigonatti, Marcolin MA, Freedman SD, Nitsche MA, Pascual-Leone A:
Transcranial direct current stimulation of the unaffected
hemisphere in stroke patients. Neuroreport 2005;16:1551-1555.
Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E,
Marcolin MA, Rigonatti SP, Silva MTA, Paulus W, Pascual-Leone A:
Anodal transcranial direct current stimulation of prefrontal cortex
enhances working memory. Exp Brain Res 2005;166: 23-30.
Fregni F, Boggio PS, Santos MC, Lima M, Vieira AL, Rigonatti SP,
Silva MT, Barbosa ER, Nitsche MA, Pascual-Leone A. Noninvasive
cortical stimulation with transcranial direct current stimulation in
Parkinson's disease. Mov Disord. 2006;21(10):1693-702.
Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L,
Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A,
Boggio PS. A randomized, sham-controlled, proof of principle study
of transcranial direct current stimulation for the treatment of pain in
fibromyalgia. Arthritis Rheum. 2006;54(12):3988-98.
Fregni F, Liebetanz D, Monte-Silva KK, Oliveira MB, Santos AA,
Nitsche MA, Pascual-Leone A, Guedes RC. Effects of transcranial
direct current stimulation coupled with repetitive electrical
stimulation on cortical spreading depression. Exp Neurol.
2007;204(1):462-6.
Fregni F, Liguori P, Fecteau S, Nitsche MA, Pascual-Leone A, Boggio
PS. Cortical stimulation of the prefrontal cortex with transcranial
direct current stimulation reduces cue-provoked smoking craving: a
randomized,
sham-controlled
study.
J
Clin
Psychiatry.
2008;69(1):32-40.
Fregni F, Orsati F, Pedrosa W, Fecteau S, Tome FA, Nitsche MA,
Mecca T, Macedo EC, Pascual-Leone A, Boggio PS. Transcranial
direct current stimulation of the prefrontal cortex modulates the
desire for specific foods. Appetite. 2008;51(1):34-41.
Furubayashi T, Terao Y, Arai N, Okabe S, Mochizuki H, Hanajima R,
Hamada M, Yugeta A, Inomata-Terada S, Ugawa Y. Short and long
duration transcranial direct current stimulation (tDCS) over the
human hand motor area. Exp Brain Res. 2008;185(2):279-86.
Galea JM, Jayaram G, Ajagbe L, Celnik P. Modulation of cerebellar
excitability by polarity-specific noninvasive direct current
stimulation. J Neurosci. 2009;29(28):9115-22.
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 44
1x1 tES Model 2001 Low-Intensity Stimulator
46.
47.
48.
49.
50.
51.
52.
53.
54.
55.
56.
Operator’s Manual
Galvez V, Alonzo A, Martin D, Mitchell P, Sachdev P, Loo C.
Hypomania induction in a bipolar II patient with transcranial Direct
Current Stimulation (tDCS). Journal of ECT 2011; 27(3):256-258
Giglia G, Mattaliano P, Puma A, Rizzo S, Fierro B, Brighina F.
Neglect-like effects induced by tDCS modulation of posterior parietal
cortices in healthy subjects. Brain Stimul. 2011 Oct;4(4):294-9.
Grundmann L, Rolke R, Nitsche MA, Pavlakovic G, Happe S, Treede
RD, Paulus W, Bachmann CG. Effects of transcranial direct current
stimulation of the primary sensory cortex on somatosensory
perception. Brain Stimul. 2011 Oct;4(4):253-60. Epub 2011 Jan 8.
Hammer A, Mohammadi B, Schmicker M, Saliger S, Münte TF.
Errorless and errorful learning modulated by transcranial direct
current stimulation. BMC Neurosci. 2011 Jul 22;12:72.
Hasan A, Nitsche MA, Herrmann M, Schneider-Axmann T, Marshall
L, Gruber O, Falkai P, Wobrock T. Impaired long-term depression in
schizophrenia: a cathodal tDCS pilot study. Brain Stimul. 2011 Sep
5.
Hesse S, Werner C, Schonhardt EM, Bardeleben A, Jenrich W, Kirker
SG. Combined transcranial direct current stimulation and robotassisted arm training in subacute stroke patients: a pilot study.
Restor Neurol Neurosci. 2007;25(1):9-15.
Hesse S, Waldner A, Mehrholz J, Tomelleri C, Pohl M, Werner C.
Combined transcranial direct current stimulation and robot-assisted
arm training in subacute stroke patients: an exploratory,
randomized multicenter trial. Neurorehabil Neural Repair. 2011
Nov-Dec;25(9):838-46.
Hunter T, Sacco P, Nitsche MA, Turner DL. Modulation of internal
model formation during force field-induced motor learning by anodal
transcranial direct current stimulation of primary motor cortex. J
Physiol. 2009;587(Pt 12):2949-61.
Jacobson L, Ezra A, Berger U, Lavidor M. Modulating oscillatory brain
activity correlates of behavioral inhibition using transcranial direct
current stimulation. Clin Neurophysiol. 2011;
Jacobson L, Koslowsky M, Lavidor M. tDCS polarity effects in motor
and cognitive domains: a meta-analytical review. Exp Brain Res.
2011;
Jang SH, Ahn SH, Byun WM, Kim CS, Lee MY, Kwon YH. The effect of
transcranial direct current stimulation on the cortical activation by
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 45
1x1 tES Model 2001 Low-Intensity Stimulator
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
Operator’s Manual
motor task in the human brain: an fMRI study. Neurosci Lett.
2009;460(2):117-20.
Javadi AH, Cheng P, Walsh V. Short duration transcranial direct
current stimulation (tDCS) modulates verbal memory. Brain Stimul.
2011;
Javadi AH, Walsh V. Transcranial direct current stimulation (tDCS) of
the left dorsolateral prefrontal cortex modulates declarative
memory. Brain Stimul. 2011 Jul 26.
Jeffery DT, Norton JA, Roy FD, Gorassini MA. Effects of transcranial
direct current stimulation on the excitability of the leg motor cortex.
Exp Brain Res. 2007;182(2):281-7.
Jo JM, Kim YH, Ko MH, Ohn SH, Joen B, Lee KH. Jo JM, Kim YH, Ko
MH, Ohn SH, Joen B, Lee KH. Enhancing the working memory of
stroke patients using tDCS. Am J Phys Med Rehabil.
2009;88(5):404-9.
Kalu UG, Sexton CE, Loo CK, Ebmeier KP. Transcranial direct current
stimulation in the treatment of major depression: a metaanalysis;Psychological Medicine, Page 1 of 10.
Keeser D, Meindl T, Bor J, Palm U, Pogarell O, Mulert C, Brunelin J,
Möller HJ, Reiser M, Padberg F. Prefrontal transcranial direct current
stimulation changes connectivity of resting-state networks during
fMRI. J Neurosci. 2011 Oct 26;31(43):15284-93.
Kim CR, Kim DY, Kim LS, Chun MH, Kim SJ, Park CH. Modulation of
cortical activity after anodal transcranial direct current stimulation
of the lower limb motor cortex: a functional MRI study. Brain Stimul.
2011;
Kincses TZ, Antal A, Nitsche MA, Bártfai O, Paulus W: Facilitation of
probabilistic classification learning by transcranial direct current
stimulation of the prefrontal cortex in the human. Neuropsychologia
2003;42:113-117.
Knoch D, Nitsche MA, Fischbacher U, Eisenegger C, Pascual-Leone
A, Fehr E. Studying the neurobiology of social interaction with
transcranial direct current stimulation--the example of punishing
unfairness. Cereb Cortex. 2008;18(9):1987-90.
Kwon YH, Ko MH, Ahn SH, Kim YH, Song JC, Lee CH, Chang MC,
Jang SH. Primary motor cortex activation by transcranial direct
current stimulation in the human brain. Neurosci Lett.
2008;435(1):56-9. Lang N, Nitsche MA, Paulus W, Rothwell JC,
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 46
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67.
68.
69.
70.
71.
72.
73.
74.
75.
Operator’s Manual
Lemon R: Effects of transcranial DC stimulation over the human
motor cortex on corticospinal and transcallosal excitability. Exp
Brain Res 2004;156:439-443.
Ladeira A, Fregni F, Campanhã C, Valasek CA, De Ridder D, Brunoni
AR, Boggio PS. Polarity-dependent transcranial direct current
stimulation effects on central auditory processing. PLoS One. 2011;
Lang N, Siebner HR, Chadaide Z, Boros K, Nitsche MA, Rothwell JC,
Paulus W, Antal A. Bidirectional modulation of primary visual cortex
excitability: a combined tDCS and rTMS study. Invest Ophthalmol Vis
Sci. 2007;48(12):5782-7.
Leite J, Carvalho S, Fregni F, Gonçalves ÓF. Task-specific effects of
tDCS-induced cortical excitability changes on cognitive and motor
sequence set shifting performance. PLoS One. 2011;
Liebetanz D, Fregni F, Monte-Silva KK, Oliveira MB, Amâncio-dosSantos A, Nitsche MA, Guedes RC. After-effects of transcranial direct
current stimulation (tDCS) on cortical spreading depression.
Neurosci Lett. 2006;398(1-2):85-90.
Loo CK, Sachdev P, Martin DM, Pigot M, Alonzo A, Malhi GS,
Lagopoulos J, & Mitchell P. A double-blind, sham-controlled trial of
transcranial direct current stimulation for the treatment of
depression. International Journal of Neuropsychopharmacology
2010; 13:61-69.
Loo CK, Martin DM, Alonzo A, Gandevia S, Mitchell PB, Sachdev P.
Avoiding Skin Burns with Transcranial Direct Current Stimulation:
Preliminary
Considerations.
International
Journal
of
Neuropsychopharmacology, 2011;14(3):425-6.
Loo CK, Alonzo A, Martin DM, Mitchell PB, Galvez V, Sachdev P.
Transcranial direct current stimulation for depression: 3-week,
randomised, sham-controlled trial. British Journal of Psychiatry
2012; 200: 52-59.
Mattai A, Miller R, Weisinger B, Greenstein D, Bakalar J, Tossell J,
David C, Wassermann EM, Rapoport J, Gogtay N. Tolerability of
transcranial direct current stimulation in childhood-onset
schizophrenia. Brain Stimul. 2011 Oct;4(4):275-80.
Marshall L, Molle M, Hallschmid M, Born J: Transcranial direct
current stimulation during sleep improves declarative memory. J
Neurosci 2004;24:9985-9992.
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Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 47
1x1 tES Model 2001 Low-Intensity Stimulator
76.
77.
78.
79.
80.
81.
82.
83.
84.
85.
Operator’s Manual
McKinley RA, Bridges N, Walters CM, Nelson J. Modulating the brain
at work using noninvasive transcranial stimulation. Neuroimage.
2012 Jan 2;59(1):129-37.
Monti A, Cogiamanian F, Marceglia S, Ferrucci R, Mameli F, MrakicSposta S, Vergari M, Zago S, Priori A. Improved naming after
transcranial direct current stimulation in aphasia. J Neurol
Neurosurg Psychiatry. 2008;79(4):451-3.
Mordillo-Mateos L, Turpin-Fenoll L, Millán-Pascual J, Núñez-Pérez N,
Panyavin I, Gómez-Argüelles JM, Botia-Paniagua E, Foffani G, Lang
N, Oliviero A. Effects of simultaneous bilateral tDCS of the human
motor cortex. Brain Stimul. 2011;
Murphy DN, Boggio P, Fregni F. Transcranial direct current
stimulation as a therapeutic tool for the treatment of major
depression: insights from past and recent clinical studies. Curr Opin
Psychiatry. 2009;22(3):306-11.
Nakamura-Palacios EM, de Almeida Benevides MC, da Penha ZagoGomes M, de Oliveira RW, de Vasconcellos VF, de Castro LN, da
Silva MC, Ramos PA, Fregni F. Auditory event-related potentials (P3)
and cognitive changes induced by frontal direct current stimulation
in alcoholics according to Lesch alcoholism typology. Int J
Neuropsychopharmacol. 2011 Jul 22:1-16.
Nitsche MA, Doemkes S, Karaköse T, Antal A, Liebetanz D, Lang N,
Tergau F, Paulus W. Shaping the effects of transcranial direct
current stimulation of the human motor cortex. J Neurophysiol.
2007;97(4):3109-17.
Nitsche MA, Paulus W: Excitability changes induced in the human
motor cortex by weak transcranial direct current stimulation. J
Physiol 2000;527:633-639.
Nitsche, MA, Paulus W: Sustained excitability elevations induced by
transcranial DC motor cortex stimulation in humans. Neurology
2001;57:1899-1901.
Nitsche MA, Schauenburg A, Lang N, Liebetanz D, Exner C, Paulus
W, Tergau F: Facilitation of implicit motor learning by weak
transcranial direct current stimulation of the primary motor cortex in
the human. J Cog Neurosci 2003;15:619-626.
Nitsche MA, Seeber A, Frommann K, Klein CC, Nitsche MS, Rochford
C, Liebetanz D, Lang N, Antal A, Paulus W, Tergau F: Modulating
parameters of excitability during and after transcranial direct
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
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86.
87.
88.
89.
90.
91.
92.
93.
94.
Operator’s Manual
current stimulation of the human motor cortex. J Physiol 2005;568:
291-303.
Ohn SH, Park CI, Yoo WK, Ko MH, Choi KP, Kim GM, Lee YT, Kim YH.
Time-dependent effect of transcranial direct current stimulation on
the enhancement of working memory. Neuroreport. 2008;19(1):437.
Palm U, Schiller C, Fintescu Z, Obermeier M, Keeser D, Reisinger E,
Pogarell O, Nitsche MA, Möller HJ, Padberg F. Transcranial direct
current stimulation in treatment resistant depression: a randomized
double-blind, placebo-controlled study. Brain Stimul. 2011;
Peña-Gómez C, Vidal-Piñeiro D, Clemente IC, Pascual-Leone Á,
Bartrés-Faz D. Down-regulation of negative emotional processing by
transcranial direct current stimulation: effects of personality
characteristics. 2011;6(7)
Peña-Gómez C, Sala-Lonch R, Junqué C, Clemente IC, Vidal D,
Bargalló N, Falcón C, Valls-Solé J, Pascual-Leone A, Bartrés-Faz D.
Modulation of large-scale brain networks by transcranial direct
current stimulation evidenced by resting-state functional MRI. Brain
Stimul. 2011;
Plazier M, Joos K, Vanneste S, Ost J, De Ridder D. Bifrontal and
bioccipital transcranial direct current stimulation (tDCS) does not
induce mood changes in healthy volunteers: a placebo controlled
study. Brain Stimul. 2011 Aug 5.
Power HA, Norton JA, Porter CL, Doyle Z, Hui I, Chan KM.
Transcranial direct current stimulation of the primary motor cortex
affects cortical drive to human musculature as assessed by
intermuscular coherence. J Physiol. 2006;577(Pt 3):795-803.
Ragert P, Vandermeeren Y, Camus M, Cohen LG. Improvement of
spatial tactile acuity by transcranial direct current stimulation. Clin
Neurophysiol. 2008;119(4):805-11.
Quartarone A, Lang N, Rizzo V, Bagnato S, Morgante F, Sant'angelo
A, Crupi D, Battaglia F, Messina C, Girlanda P. Motor cortex
abnormalities in amyotrophic lateral sclerosis with transcranial
direct-current stimulation. Muscle Nerve. 2007;35(5):620-4.
Reis J, Fritsch B. Modulation of motor performance and motor
learning by transcranial direct current stimulation. Curr Opin Neurol.
2011 Dec;24(6):590-6.
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Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Page 49
1x1 tES Model 2001 Low-Intensity Stimulator
95.
96.
97.
98.
99.
100.
101.
102.
103.
104.
105.
106.
Operator’s Manual
Riedel P, Kabisch S, Ragert P, von Kriegstein K. Contact dermatitis
after transcranial direct current stimulation. Brain Stimul. 2011;
Roche N, Lackmy A, Achache V, Bussel B, Katz R. Effects of anodal
tDCS on lumbar propriospinal system in healthy subjects. Clin
Neurophysiol. 2011 Oct 18.
Rogalewski A, Breitenstein C, Nitsche MA, Paulus W, Knecht S:
Transcranial direct current stimulation disrupts tactile perception.
Eur J Neurosci 2004;20:313-316.
Roizenblatt S, Fregni F, Gimenez R, Wetzel T, Rigonatti SP, Tufik S,
Boggio PS, Valle AC. Site-specific effects of transcranial direct
current stimulation on sleep and pain in fibromyalgia: a randomized,
sham-controlled study. Pain Pract. 2007;7(4):297-306.
Rosenkranz K, Nitsche MA, Tergau F, Paulus W. Diminution of
transient motor cortex plasticity by weak transcranial direct current
stimulation in the human. Neurosci Lett 2000;296;61-63.
Schlaug G, Renga V, Nair D. Transcranial direct current stimulation
in stroke recovery. Arch Neurol. 2008;65(12):1571-6.
Schlaug G, Renga V. Transcranial direct current stimulation: a
noninvasive tool to facilitate stroke recovery. Expert Rev Med
Devices. 2008;5(6):759-68.
Schlaug G, Marchina S, Wan CY. The use of non-invasive brain
stimulation techniques to facilitate recovery from post-stroke
aphasia. Neuropsychol Rev. 2011 Sep;21(3):288-301.
Siebner HR, Lang N, Rizzo V, Nitsche MA, Paulus W, Lemon RN,
Rothwell JC.: Preconditioning of low-frequency repetitive transcranial
magnetic stimulation with transcranial direct current stimulation:
evidence for homeostatic plasticity in the human motor cortex. J
Neurosci 2004;24:3379-3385.
Sparing R, Dafotakis M, Meister IG, Thirugnanasambandam N, Fink
GR. Enhancing language performance with non-invasive brain
stimulation--a transcranial direct current stimulation study in healthy
humans. Neuropsychologia. 2008;46(1):261-8.
Tanaka S, Hanakawa T, Honda M, Watanabe K. Enhancement of
pinch force in the lower leg by anodal transcranial direct current
stimulation. Exp Brain Res. 2009;196(3):459-65.
Tanaka S, Sandrini M, Cohen LG. Modulation of motor learning and
memory formation by non-invasive cortical stimulation of the
Copyright © 2012-15, Soterix Medical Inc.
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
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107.
108.
109.
110.
111.
112.
113.
114.
115.
Operator’s Manual
primary motor cortex. Neuropsychol Rehabil. 2011 Oct;21(5):65075.
Teo F, Hoy KE, Daskalakis ZJ, Fitzgerald PB. Investigating the Role of
Current Strength in tDCS Modulation of Working Memory
Performance in Healthy Controls. Front Psychiatry. 2011;2:45.
Terney D, Bergmann I, Poreisz C, Chaieb L, Boros K, Nitsche MA,
Paulus W, Antal A. Pergolide increases the efficacy of cathodal
direct current stimulation to reduce the amplitude of laser-evoked
potentials in humans. J Pain Symptom Manage. 2008;36(1):79-91.
Vanneste S, Langguth B, De Ridder D. Do tDCS and TMS influence
tinnitus transiently via a direct cortical and indirect somatosensory
modulating effect? A combined TMS-tDCS and TENS study. Brain
Stimul. 2011 Oct;4(4):242-52.
Vanneste S, De Ridder D. Bifrontal transcranial direct current
stimulation modulates tinnitus intensity and tinnitus-distress-related
brain activity. Eur J Neurosci. 2011 Aug;34(4):605-14.
Varga ET, Terney D, Atkins MD, Nikanorova M, Jeppesen DS, Uldall
P, Hjalgrim H, Beniczky S. Transcranial direct current stimulation in
refractory continuous spikes and waves during slow sleep: a
controlled study. Epilepsy Res. 2011 Nov;97(1-2):142-5.
Venkatakrishnan A, Sandrini M. Combining Transcranial Direct
Current Stimulation and neuroimaging: Novel insights in
understanding neuroplasticity. J Neurophysiol. 2011 Aug 10.
Vines BW, Cerruti C, Schlaug G. Dual-hemisphere tDCS facilitates
greater improvements for healthy subjects' non-dominant hand
compared to uni-hemisphere stimulation. BMC Neurosci.
2008;9:103.
Webster BR, Celnik PA, Cohen LG. Noninvasive brain stimulation in
stroke rehabilitation. NeuroRx. 2006;3(4):474-81.
Zaehle T, Beretta M, Jäncke L, Herrmann CS, Sandmann P.
Excitability changes induced in the human auditory cortex by
transcranial direct current stimulation: direct electrophysiological
evidence. Exp Brain Res. 2011 Nov;215(2):135-40.
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Page 51
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Contact Information
Soterix Medical Inc.
160 Convent Avenue ,ST-142
New York, NY 10031
Tel: 212-650-8260
Fax: 212-315-3232
Email: [email protected]
Internet: www.SoterixMedical.com
Authorized Representative for the European Community:
mdi Europa GmbH
Langenhagener Str. 71
D-30855 Langenhagen
Tel: +49-511-3908 9530
Fax: +49-511-3908 9539
Email: [email protected]
Internet: www.mdi-europa.com
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Page 52
1x1 tES Model 2001 Low-Intensity Stimulator
Operator’s Manual
Thank you for purchasing a Soterix Medical 1x1 Transcranial
Electrical Low-Intensity Stimulator Model 2001.
If you arrive at a problem, or have any questions, comments, or
concerns, please feel free to contact us at SoterixMedical.com
Manufacturer
Soterix Medical,Inc.
160 Convent Ave, ST 142
New York, NY 10031
Tel: 888-990-TDCS
Fax:212-315-3232
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www.SoterixMedical.com
Page 53

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Key Features

  • TRUE CURRENTTM
  • SMARTscan-ESTM
  • RELAX
  • PRE-STIM TICKLE
  • Waveform Polarity
  • Adjustable Frequency
  • Adjustable Duration
  • Adjustable Intensity

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Frequently Answers and Questions

What is the purpose of the TRUE CURRENTTM feature?
TRUE CURRENTTM displays the actual current being delivered by the device, regardless of settings. It's a safety feature that helps monitor stimulation accuracy.
How does the SMARTscan-ESTM feature work?
SMARTscan-ESTM monitors electrode contact quality using a 10-bar LED display. A higher bar indicates better contact. This feature helps ensure consistent stimulation.
What are the different waveforms available on the Soterix Medical 2001?
The device offers four waveforms: tDCS, tPCS, tACS, and tRNS. Each waveform has its own unique characteristics and applications.
How do I change the stimulation intensity?
You can adjust the intensity using the intensity control knob on the front panel. The device allows you to select from four intensity levels: 1, 1.5, 1.75, or 2 mA.
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