Caputron ActivaDose II - Avoid Temporal and Orbital Regions; Electrical Sensitivity; Drug Allergy Screening; Electrode Reject Feature

2
8. Do not apply electrodes over or across the right and left temporal
regions, or use the ActivaDose® II Iontophoresis Delivery Unit and
electrodes for treatment of the orbital region. Doing so may cause
transient visual disturbances.
9. Patients with known sensitivity to electrical current should be treated
with lower current settings than those recommended for general use.
If a treatment results in prolonged skin irritation or burns, consult a
physician and do not give additional treatments.
10. Patients should be asked about their history of drug allergies or
sensitivities. The ActivaDose® II Iontophoresis Delivery Unit and
electrodes should not be used on any patient who demonstrates a known
allergy or sensitivity to the drug being administered. Consult the drug
package insert for additional contraindications and
warnings.
11. The “REJECT” safety feature of the ActivaDose® II Iontophoresis Delivery
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
patient whenever an electrode reject occurs. Do not disconnect the
lead wires from the electrodes, or the electrodes from the patient while
the current is ON since this will cause the reject feature to function. The
patient should avoid unnecessary movement during the treatment to
ensure that an inadvertent disconnection of an electrode or lead wire
does not occur.
12. Refer to the directions for use supplied with the iontophoresis
electrodes for important additional information.
13. For use with ActivaTek electrodes.
IV. THEORY OF OPERATION
Iontophoresis can be used to transport soluble drug ions across intact skin. The
technology is based on the principle that an electric potential will cause ions
in solution to migrate according to their electrical charges. The quantity and
distribution of a drug delivered by iontophoresis is dependent upon the charge
of the ion, the size of the ion (molecular weight), the strength of the electrical
current being applied, electrode composition, the duration of current flow and
numerous other factors.
V. ACTIVADOSE® II IONTOPHORESIS DELIVERY UNIT SAFETY AND
CONVENIENCE FEATURES
A. Description: The ActivaDose® II Iontophoresis Delivery Unit is a solid state,
microprocessor controlled device utilized to administer soluble salts or other
drugs. 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: 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 a treatment can be started.