Notice; Warnings And Precautions - Caputron ActivaDose II tDCS User Manual

Activadose tDCS Device User Manual

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
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