ActivaDose II Iontophoresis Dose Controller | 0–80 mA·min

The ActivaDose II Iontophoresis Delivery Unit is a reusable, prescription dose controller designed for clinician-directed administration of soluble salts and other appropriate medications through intact skin using controlled direct current.

The practitioner selects the prescribed dose in milliampere-minutes, or mA·min, and sets the treatment current. ActivaDose II then calculates the required treatment time automatically and adjusts the remaining time if the current is changed or treatment is paused.

A high-contrast display shows dose, actual current, and time remaining. Automatic current ramp-up and ramp-down, resistance monitoring, electrode-reject protection, limit indicators, and audible alerts help support a controlled professional treatment workflow.

The controller operates on one replaceable 9V alkaline battery and is supplied with two lead wires, two 9V batteries, and an operating manual. Disposable iontophoresis electrodes and medication are sold separately.

This device to sale by or on the order of a physician or appropriately licensed practitioner. Medication selection, polarity, dose, current, electrode choice, placement, and patient monitoring require professional direction.

• Professional single-channel iontophoresis controller
• ActivaTek model 001-48
• North Coast Medical item NC89186
• FDA-cleared prescription medical device
• Adjustable dose from 0–80 mA·min
• Fine 0.1 mA·min dose increments
• Adjustable current up to 4.0 mA
• Current adjustments in 0.1 mA increments
• Maximum output of 80 V DC
• Automatic treatment-time calculation
• Automatic time recalculation after current changes
• Pause-and-resume function retains delivered dose
• Gradual automatic current ramp-up
• Automatic ramp-down at treatment completion
• Manual current-ramp option
• High-contrast dose, current, and time display
• Resistance-limit monitoring
• Current- and dose-limit alerts
• Electrode-reject safety function
• Low-battery warnings and battery-reject protection
• Automatic shutoff after approximately one minute of inactivity
• Lightweight 0.4-pound design
• One-year manufacturer device warranty
• Designed for use with compatible professional iontophoresis electrodes

ActivaTek lists the 0–80 mA·min dose range, 0.1 mA·min increments, automatic ramping, 80 V maximum output, visual and audible alerts, and one-year warranty.

The controller uses one 9V alkaline battery at a time. The manual specifically says not to use rechargeable batteries.

Not included:

• Prescription medication or solution
• Active drug-delivery electrode
• Dispersive or return electrode
• Alcohol prep pads, except when supplied with a separately purchased electrode kit
• Carrying case unless specifically included in the current Balego package

Pair the controller with Trivarion Iontophoresis Delivery Kits or another compatible controller-based electrode system.

An iontophoresis dose is expressed in mA·min:

Current in milliamps × treatment time in minutes = dose in mA·min

After the clinician selects the dose and current, ActivaDose II calculates the treatment time automatically.

40 mA·min dose

These examples illustrate the mathematics only. The correct dose and current must come from the medication order, electrode instructions, treatment location, skin condition, patient tolerance, and clinical protocol. The manufacturer recommends lower current for sensitive anatomical sites, current-sensitive patients, and thin or fragile skin.

Reducing current increases the remaining treatment time so the selected dose can still be delivered. For example, changing from 4 mA to 2 mA approximately doubles the time needed to deliver the same remaining mA·min dose.

Automatic current ramp-up

When treatment begins, the current rises gradually toward the selected setting. The clinician can lower the current at any point if the patient reports discomfort.

After the prescribed dose has been delivered, the controller gradually reduces current to zero and sounds an end-of-treatment alert.

The controller also ramps down before shutdown and during certain low-battery conditions.

Pressing the current control—or reducing current to zero—pauses treatment. The device retains the dose already delivered.

When treatment restarts, ActivaDose II recalculates the remaining time and ramps the current up again.

A high-resistance treatment site may prevent the device from reaching the selected current. The controller displays a resistance-limit warning while continuing at the highest achievable output and adjusting time as needed.

The electrode-reject system stops current if the device detects a break or unsuitable condition in the treatment circuit.

Possible causes include the following:

• Loose lead-wire connection
• Electrode lifting from the skin
• Dry or poorly prepared skin
• Insufficient medication or hydration
• Inappropriate medication formulation
• Incorrect electrode setup
• Broken or interrupted circuit

The unit beeps, flashes the reject indicator, displays an electrode-reject message, and turns off current.

The manufacturer summarizes operation as three main actions:

1. Select dose.
2. Set current.
3. Start treatment.

A complete clinical workflow includes several additional safety steps:

The manual calls for intact skin, correct electrode fill volume, alcohol preparation followed by complete drying, and approximately 4–6 inches between the drug and dispersive electrodes when allowed by the electrode instructions.

The controller must be paired with a compatible active drug electrode and return electrode. The disposable electrode instructions determine:

• Maximum permitted dose
• Maximum current
• Medication fill volume
• Electrode polarity
• Hydration requirements
• Site preparation
• Electrode spacing
• Treatment-area suitability

Trivarion is specifically designed for ActivaDose II and is available in small, medium, butterfly, and large formats. Ionto4 is designed for FDA-cleared constant-current iontophoresis devices and likewise provides multiple fill-volume and shape options.

The clinician must choose the electrode using the prescribed medication volume, anatomical site, dose, and electrode instructions—not size alone.

The ActivaDose II gives the clinician direct control over current and dose while the patient remains connected to the unit. IontoPATCH and ACTIVApatch integrate the power source into a disposable patch and require no external controller or lead wires.

• Direct clinician control of current is important.
• The clinic wants to set and document a precise mA·min dose.
• A shorter connected treatment is preferred over extended patch wear.
• The facility already uses controller-based electrodes.
• A reusable controller is more economical for repeated clinic treatments.
• Staff are familiar with traditional Phoresor-style iontophoresis workflows.
• Electrode shape and fill volume need to be selected for each treatment area.

The ActivaDose II is a replacement option for clinics transitioning from a Phoresor II workflow.

Remove the battery when the unit will not be used for an extended period.

The manufacturer’s troubleshooting section identifies loose connections, electrode lift, insufficient medication, improper hydration, inappropriate medication, high resistance, and low battery as common causes of alerts.

• Never reuse single-use electrodes.
• Do not tape, bind, or compress electrodes against the skin.
• Do not use damaged or altered electrodes.
• Remove jewelry that could contact either electrode.
• Do not disconnect electrodes while current is flowing.
• Use lower current for fragile skin, sensitive sites, or current-sensitive patients.
• Do not exceed the limits specified by the controller, medication order, or electrode IFU.
• Do not immerse the controller or connect it to unauthorized external devices.
• Inspect and document the skin after treatment.

• ActivaDose II Product Manual and Setup Guide
• Iontophoresis FAQ Guides
• Iontophoresis Protocol for Tennis Elbow
• Contact Balego