Soterix Medical 2001 User manual

1x1 Low-Intensity Transcranial Electrical Stimiulator (tES)
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Model 2001
Operator’s Manual

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-2015, Soterix Medical Inc Page ii
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Version 2
July 2015

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-2015, Soterix Medical Inc Page iii
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
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.

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-2015, Soterix Medical Inc Page iv
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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.

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-2015, Soterix Medical Inc Page v
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This page is left intentionally blank to provide an insertion place of any changes subsequent to
the printing of this document.

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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

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 1
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www.SoterixMedical.com
Introduction
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.
Intended Use - 2
Getting to Know the
Product - 4
Use of this Manual - 6

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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

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 3
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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.

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 4
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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.

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 5
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www.SoterixMedical.com
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.

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 6
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
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.

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 7
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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

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 8
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Health and Safety
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.
Precautions and
Warnings - 9
Regulatory
Statements - 12

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 9
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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
oDo not immerse the Soterix Medical 1x1 tES Low-Intensity
Stimulator in water or any other fluids.
oThe 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.
oThe 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.
oThe 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.
oDo 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 Low-
Intensity Stimulator are unknown.
oDo 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.

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 10
Investigational device. Federal (or United States) law limits device to investigational use.
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External Damage
oDo not drop the device.
oThe Soterix Medical 1x1 tES Low-Intensity Stimulator should not
be used if there are any signs of external damage.
oCarefully inspect the device on arrival and prior to each use.
oIf 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
oWhen connecting cables to the output jacks, use only the
cables provided or sold by Soterix Medical Inc. to maintain
compliance with product regulations.
oMake sure all cables are fully inserted in the correct receivers
before operating the Soterix Medical 1x1 tES Low-Intensity
Stimulator.
Irritation
oUse 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.
oThe Soterix Medical 1x1 tES Low-Intensity Stimulator may cause
minor irritation, discomfort and redness at the electrode sites. If
irritation occurs, consult your clinician.
oDo not place the Soterix Medical 1x1 tES electrodes or sponges
over previously irritated, burnt, or damaged skin.
oSince 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.

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 11
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Internal Parts
oDo 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.
oNo modification of the Soterix Medical 1x1 tES Low-Intensity
Stimulator is allowed.
Batteries
oObserve proper precautions when handling batteries. Be sure
the product is off before replacing batteries.
oUse only batteries approved for use in this equipment. Do not
attempt to insert batteries upside down or backwards.
Electronic Monitoring
oElectronic monitoring equipment (such as ECG monitors, ECG
alarms) may not operate properly when tES stimulation is in
use.
Technique
oThe 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.
oPresence 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.
oAll operators must ensure that Soterix Medical 1x1 tES Low-
Intensity Stimulator is applied within local and federal or
country guidelines as relevant.

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 12
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oThe 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.

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 13
Investigational device. Federal (or United States) law limits device to investigational use.
www.SoterixMedical.com
Product Description
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.
Items Supplied - 14
Front Panel - 15
Back Panel - 16
Control Keys - 17

1x1 tES Model 2001 Low-Intensity Stimulator Operator’s Manual
Copyright © 2012-15, Soterix Medical Inc. Page 14
Investigational device. Federal (or United States) law limits device to investigational use.
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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 )