Contraindications; Indications For Use; Introduction; Activadose Ii Tdcs Unit Safety And Convenience Features - Caputron ActivaDose II tDCS User Manual

Activadose tDCS Device User Manual
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
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.
safe and effective treatment for
4
Caputron