Trivarion Activadose™ Iontophoresis Delivery Unit Trivarion Activadose™ Iontophoresis Delivery Unit

The Trivarion Activadose™ Iontophoresis Delivery Unit is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injection in situations when it is advisable to avoid the pain that may accompany needle insertion and drug injection, when it is advisable to minimize the infiltration of carrier fluids, or to avoid the damage caused by needle insertion when tissue is traumatized.

CONTRAINDICATIONS:
The Activadose™ Iontophoresis Delivery Unit is contraindicated for use on patients with electrically sensitive support systems (e.g., pacemakers) and patients with known allergy or sensitivity to the drugs to be administered. It is contraindicated for use over damaged or denuded skin or other recent scar tissue, across the right and left temporal regions and for treatment of the orbital region.

WARNINGS AND PRECAUTIONS:
A. Never attempt to reuse single-use electrodes. Discard after use.
B. Iontophoresis can cause skin irritation and burns. Patients should be advised of this potential. It is important to note the following:
1. Continuous direct current used in iontophoresis can cause transient (uniform or mottled) erythema under either electrode which will generally resolve within a few hours to a few days.
2. Advise patient to report any undue burning or pain during treatment at once. Pause the treatment, inspect the area under the electrodes and make any necessary corrective actions before resuming the treatment.
3. Patients should remove any jewelry that may come in contact with either electrode. Failure to do so may cause burns.
4. Do not exceed maximum levels of current or dose (total delivered charge):
Maximum current: 4.0 milliamps (mA).
Maximum dose: Refer to directions for use supplied with electrodes.
5. Failure to observe the following precautions may result in excessive skin irritation or burns:
Do not tape, bind or compress electrodes during treatment.
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™ Iontophoresis Delivery Unit and electrodes on patients with electrically sensitive support systems (e.g., pacemakers). Doing so may cause the support system to malfunction.
7. Exercise caution in handling the Activadose™ Iontophoresis Delivery 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 patient injury.
8. Do not apply electrodes over or across the right and left temporal regions, or use the Activadose™ 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™ Iontophoresis Delivery Unit and electrodes should not be used on any patient who demonstrates a known allergy or sensitivity to the drug being administered.
11. The “REJECT” safety feature of the Activadose™ 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.

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.

ACTIVADOSE™ IONTOPHORESIS DELIVERY UNIT SAFETY AND CONVENIENCE FEATURES
A. Description: The Activadose™ 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: 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.
C. Automatic Time Calculation: Only the desired dose and current need to be entered for a treatment. All time calculations are performed automatically, even if dose and current settings are changed.
D. Automatic Current Ramp Up: After selecting the desired dose and setting the current, treatment can be started. The unit automatically ramps up the current output at a rate comfortable for most patients. The current may be adjusted for patient comfort any time during treatment, including during current ramp up.
E. Automatic or Manual Current Ramp Down: After the preset dose is reached, the current automatically ramps down to 0.0 mA and the unit beeps, terminating the treatment. Also, automatic current ramp down takes place if a “LOW BATTERY REJECT” occurs during treatment. Current may be turned off manually any time, including during ramp up, to terminate treatment.
F. Resistance Limit: Occasionally, when treating high resistance skin areas, such as the plantar surface of the foot, the unit may beep and flash “RESISTANCE LIMIT” on the display. However, the unit will continue treatment if possible. As resistance drops during treatment, the unit will automatically ramp up the current to the desired level, or as high as possible if the desired level cannot be reached.
G. Dose and Current Limit: The unit will beep and the dose display will flash “LIMIT” if an attempt is made to turn the dose knob beyond the upper limit of 80.0 mA-min. (milliamps-minutes). Also, the unit will beep and the current display will flash “LIMIT” if an attempt is made to turn the current knob beyond the maximum of 4.0 mA. Refer to directions for use supplied with electrodes for maximum recommended dose and current.
H. Electrode Reject: Circuit problems (e.g., loose electrodes, dry skin, improperly connected electrodes, inappropriate drugs, etc.) can cause an “ELECTRODE REJECT.” The unit beeps, the “REJ” light flashes and the display shows “ELECTRODE REJECT.” The current output is turned off automatically. See Section X, “Troubleshooting,” to correct the problem.

SPECIFICATIONS: