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The Activatek ActivaPatch ET Intophoresis Patch is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.

The Activatek ActivaPatch ET Iontophoresis Patch consists of a self-contained, disposable single-use iontophoresis patch, instructions for use, and an alcohol prep pad containing 70% isopropyl alcohol. The ActivaPatch ET lontophoresis Patch contains an electronic module, an Active Electrode, and a Return Electrode. These elements are incorporated under an adhesive non-woven fabric covering which adheres the device to the skin. The overall dimensions of the ActivaPatch ET are 5.7 inches (length), 3.4 inches (width), and 0.2 inches (thickness). Principle of Operation: Iontophoresis is a process that uses an electrical field across intact skin to propel charged ions into the skin and underlying tissue. The electrodes (Active and Return) are applied directly to the skin to transit the electric field. If the ion is negatively charged, then the negative electrode is designated the Active Electrode and the positive electrode is the Return Electrode. The total dose of all ions transported through the skin is proportional to the total current passed between the electrodes. Units of iontophoresis dosages are conventionally given in terms of mAmp*min, calculated by multiplying the amount of current by the time of application of the current.

The ActivaTek ActivaPatch Iontophoresis System is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.

The ActivaTek ActivaPatch Iontophoresis System (Iontophoresis Patch) consists of a self-contained, disposable single-use iontophoresis patch, instructions for use, and an alcohol prep pad containing 70% isopropyl alcohol. The Iontophoresis Patch consists of an electronic module, an LED indicator, an active electrode, and a return electrode. These elements are incorporated under an adhesive foam covering which adheres the device to the skin. Its dimensions are 5.7 inches (length), 3.4 inches (width), and 0.2 inches (thickness). The Iontophoresis Patch is designed to deliver a calibrated and fixed half dose of 40 mAmp*minutes and a full dose of 80 mAmp*minutes. The ActivaPatch Iontophoresis System sequence of operation is signaled by its LED. - a) The operator applies the ActivaPatch to the skin. - b) The operator then pulls the tab located on the outer surface of the patch. - c) In the Initial Skin Impedance Measurement Phase, the ActivaPatch measures voltage across the active and return electrodes to indicate the level of skin impedance. For high skin impedance, the LED flashes once every 4 seconds. This indicates that the skin impedance is too high for iontophoretic delivery. The treatment timer is not started. For moderate skin impedances, the LED flashes pulses four times every 30 seconds. The patch continues to monitor the skin impedance but does not turn on the treatment timer. When the skin impedance becomes optimal, the LED blinks once every 30 seconds. This indicates that the impedance is appropriate to start an iontophoretic treatment session and the ActivaPatch starts the treatment timer. - d) In the First Half Dose Delivery Phase, the ActivaPatch LED continues to blink once every 30 seconds. This phase lasts 80 minutes and delivers an ionic dosage of 40 mA*minutes. At the end of the First Half Dose Delivery, the LED blinks short-long-short sequences every 30 seconds for 3 minutes. This signals to the user that the transition to the Second Half Dose Delivery Phase has begun. - e) During the Second Half Dose Delivery Phase, the ActivaPatch LED blinks two pulses every 30 seconds. During this final phase, another 40 mA*minute dose is delivered. At the end of the delivery, the power in the device is automatically shut off and the LED does not blink. - f) If at any time the skin impedance increases to high levels (e.g., the electrode falls off of the skin site) the ActivaPatch goes into the Skin Measurement Phase and the LED flashes pulses once every 4 seconds. The treatment timer is suspended and restarts when the skin impedance falls to optimal levels.