Caputron ActivaDose II tDCS User manual

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Activadose tDCS Device User Manual
Caputron !
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Contents!
Activadose!II!tDCS!Device!at!a!glance!...........................................................................................................!2!
Notice!...........................................................................................................................................................!3!
Warnings!and!Precautions!...........................................................................................................................!3!
Contraindications!.........................................................................................................................................!4!
Indications!for!Use!.......................................................................................................................................!4!
Introduction!.................................................................................................................................................!4!
Activadose!II!tDCS!Unit!Safety!and!Convenience!Features!..........................................................................!4!
Setting!Up!the!Activadose!II!tDCS!Unit!.........................................................................................................!5!
Preparing!Electrodes!and!User!for!tDCS!Session!..........................................................................................!6!
Operating!the!Activadose!II!tDCS!Unit!.........................................................................................................!6!
Electrode!Placements!...................................................................................................................................!8!
Saline Application!......................................................................................................................................!8!
Sponge!and!Electrode!Maintenance!............................................................................................................!8!
Activadose!II!tDCS!Unit!Maintenance!...........................................................................................................!8!
Troubleshooting!...........................................................................................................................................!9!
Specifications!.............................................................................................................................................!10!
Warranty!....................................................................................................................................................!11!
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Activadose tDCS Device User Manual
Caputron !
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Activadose!II!tDCS!Device!at!a!glance!
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Order Number: 001-48
A/W 001-116 Rev
B P/N 001-49 Rev B
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Activadose tDCS Device User Manual
Caputron !
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Notice!
This unit and its original packaging are cleared by the FDA (Federal Food and Drug
Administration); in order to retain this clearance, Caputron is not permitted to alter the
label. Please refer to the instructions on this manual only, for directions relevant to tDCS
usage with the Activadose II unit.
Warnings!and!Precautions!
A. Never attempt to reuse single-use electrodes. If you are using electrodes designed
for single-use, discard after use.
B. tDCS can cause skin irritation and burns. Users should be advised of this potential. It
is important to note the following:
1. Continuous direct current used in tDCS can cause transient (uniform or mottled)
erythema under either electrode which will generally resolve within a few hours to a few
days.
2. Advise user to report any undue burning or pain during stimulation at once. Pause
stimulation, inspect area under the electrodes and make any necessary corrective
actions before resuming the tDCS session.
3. Users should remove any jewelry that may come in contact with either electrode. Failure
to do so many cause burns.
4. Do not exceed maximum levels of current or dose (total delivered charge):
Maximum current: 4.0 or 2.0 milliamps (mA), depending on version.
Maximum dose: Please refer to “LOTES-2017” paper by Dr. Marom Bikson—
https://www.neuralengr.org/wp-content/uploads/2017/11/Limited-output-
transcranial-electrical-stimulation-LOTES-2017.pdf.
5. Failure to observe the following precautions may result in excessive skin irritation or
burns.
Do not use electrodes that have been altered or appear damaged.
Do not apply electrodes over damaged skin.
Do not reuse single-use electrodes.
6. Do not use the ActivaDose II tDCS Unit and electrodes on individuals with electrically
sensitive support systems (e.g., pacemakers). Doing so may cause the support system
to malfunction.
7. Exercise caution in handling the ActivaDose II tDCS Unit. Do not allow it to be dropped
or immersed in fluids. Do not connect unit to external devices. Doing so may cause a
malfunction or user injury.
8. Users with known sensitivity to electrical current should be stimulated with lower current
settings than those recommended for general use. If transcranial stimulation results in
prolonged skin irritation or burns, consult a physician and do not attempt additional
uses.
9. The “REJECT” safety feature of the ActivaDose II tDCS Unit terminates the delivery of
the electric current to the electrodes whenever an interruption in the electrical circuit
occurs. This is indicated by the flashing “REJ” light, beeps and a flashing “ELECTRODE
REJECT” on the display. A mild shocking sensation may be experienced by the user
whenever an electrode reject occurs. Do not disconnect the lead wires from the
electrodes, or the electrodes from the user while the current is ON since this will cause
the reject feature to function. The user should avoid unnecessary movement during

Activadose tDCS Device User Manual
Caputron !
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transcranial stimulation to ensure that an inadvertent disconnection of an electrode or
lead wire does not occur.
C. Do not allow children to handle the Activadose II without adult supervision.
Contraindications!
When performing studies on subjects, the contraindications issued by the Institutional
Review Board (IRB) for tDCS are the following: The Activadose II tDCS Unit is
contraindicated for use on patients with electrically sensitive support systems (e.g.,
pacemakers). On subjects with metal implants in the head. On subjects that are
pregnant. It is also contraindicated for use over damaged or denuded skin or other
recent scar tissue
Indications!for!Use!
tDCS is classified as investigational technology by the US Food and Drug
Administration (FDA), therefore tDCS does not have any medical indications for
treatment of any kind. In the EU, tDCS is classified as a safe and effective treatment for
depression, fibromyalgia and migraine.
Introduction!
The Activadose II stimulator is originally FDA cleared for iontophoresis—which
facilitates drug delivery through the skin via a weak DC current. This device’s waveform
and stimulation parameters allow this device to be easily adapted for tDCS; this enables
consumers to access a medical grade tDCS device for use at home.
Activadose!II!tDCS!Unit!Safety!and!Convenience!Features!!
A. Description: The ActivaDose II tDCS Unit is a solid state, microprocessor controlled
device utilized to deliver direct current for tDCS use. The microprocessor performs
several safety tests continually from the time of power on and other safety tests
depending upon the mode of operation.
B. Display Help: During normal operation the display provides guidance. Various prompts
help in performing the next step. In only a few seconds, the dose and current can be set
and tDCS can be started.
C. Turning the Dose Controller ON and OFF: The dose controller can be turned ON by
depressing the On/Dose/Start knob OR turning it clockwise. The unit can be turned OFF
by depressing the On/Dose/Start knob. Note: If stimulation is being performed and the
unit is turned off, it will automatically ramp down prior to shut-off.
D. Pause Feature: If a pause in a tDCS session is desired, pressing the CURRENT knob
will automatically ramp down the current and place the unit in pause mode. The current
can also be turned down manually to activate pause mode. To restart the tDCS session,
set the current to the desired level and turn the On/Dose/Start knob clockwise. The unit
will automatically recalculate the stimulation time, ramp up and continue tDCS.
E. Automatic Time Calculation: Only the desired dose and current need to be entered for
a tDCS. All time calculations are performed automatically, even if dose and current
settings are changed or the unit is paused.