Caputron ActivaDose II User manual

Iontophoresis Delivery Unit
CAUTION: Federal law (USA)
restricts this device to use by or
on the order of a physician.
Order Number: 001-48
A/W 001-116 Rev B
P/N 001-49 Rev B
BAT REJ
Read Before Use

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I. INDICATIONS
The ActivaDose® II 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.
II. CONTRAINDICATIONS
The ActivaDose® II 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.
III. WARNINGS AND PRECAUTIONS
CAUTION: Federal law restricts this device to sale by or on the order of a
physician.
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® II 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® II 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.

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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.

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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
a treatment 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 treatment 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 treatment, set the current to the desired level and turn
the On/Dose/Start knob clockwise. The unit will automatically recalculate the
treatment time, ramp up and continue the treatment.
E. 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 or the unit is paused.
F. 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.
G. 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.
H. Resistance Limit: Occasionally, when treating high resistance skin areas, such
as the plantar surface of the foot, the unit may beep and flash “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.
I. 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.
J. 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.
VI. SETTING UP THE ACTIVADOSE® II IONTOPHORESIS
DELIVERY UNIT
A. Install 9V Battery: Do not use rechargeable type batteries.
1. Prior to a treatment, if battery power is too weak for proper circuit opera-
tion, the current output of the unit will remain disabled and the “BAT”
indicator will light. If a treatment is attempted, the alarm will sound and
the display will flash
“LOW BATTERY.”

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2. The battery compartment is at the rear of the unit. To open, gently
press the door inward and slide it open. Polarity symbols (+) and (-) are
marked on the inside of the compartment. If the battery is installed
incorrectly, with the polarity reversed, the unit will not operate. Be sure
the door is fully closed after installing the battery.
NOTE: always insert battery FLAT into the battery compartment. Use
battery strap to remove. DO NOT remove or insert battery at an angle
or attempt to pry battery from the compartment, as this will damage
battery contacts.
B. Twin Lead Connectors: Connect the appropriate twin lead connector to the
ActivaDose® II Iontophoresis Delivery Unit (see Figure 1).
VII. PREPARING ELECTRODES AND PATIENT FOR TREATMENT
NOTE: Please refer to the directions for use supplied with electrodes for detailed
instructions. Do not tape, bind or compress either electrode against the skin during
treatment. Doing so may cause excessive skin irritation or burns.
A. Examine the skin sites for both electrodes. The skin must be free of damage,
i.e., avoid broken skin, skin with ingrown hairs, acne, razor nicks, wounds that
have not healed, recent scar tissue, etc.
B. Prepare the drug electrode according to the directions for use supplied
with the electrodes. Always refer to directions for use supplied with
electrodes for correct fill volumes. Caution: Do not over- or under-fill
electrodes.
C. Prepare the skin sites for both electrodes by briskly rubbing the areas with an
alcohol wipe to remove dry skin, oils and other contaminants. Allow the skin
to dry thoroughly. Remove any jewelry that may come in contact with either
electrode.
D. Apply the drug electrode over the treatment site according to the directions
for use supplied with the electrodes.
E. Apply the dispersive pad over a major muscle at least 4” to 6 “ (10 to 15cm)
away from the drug electrode according to the electrode’s directions for
use. Avoid placing the dispersive pad over a bony prominence with minimal
tissue thickness; excessive skin irritations or burns may result.
F. Attach the twin lead connector clips to the electrodes. Refer to the
directions for use supplied with the electrodes for specific guidelines
concerning polarity.
VIII. OPERATING THE ACTIVADOSE® II IONTOPHORESIS
DELIVERY UNIT
Normally, a typical treatment requires only three steps:
1. Select Dose
2. Set Current
3. Start Treatment.
A. Select Dose: Depress the ON / DOSE / START knob or turn clockwise to
turn on the unit. The unit performs a “System Check.” The unit is preset at
40.0 mA-min (milliamps-minutes) dose. If desired, dose can be changed.
Refer to directions for use supplied with electrodes for specific information
concerning recommended dosages.

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EXAMPLE: For a 40 mA-minute dose, the display shows:
NOTES:
1. Maximum possible dose is 80 mA-min. The unit beeps and the display
flashes “LIMIT” if an attempt is
made to exceed 80 mA-min.
2. After a two-second delay, current
can be set.
B. Set Current: Read electrode instructions for recommended current.
Turn the CURRENT knob clockwise to set the current. Maximum possible
is 4.0 mA.
EXAMPLE: To deliver 4.0 mA of current, the
display shows:
IMPORTANT: Current lower than 4.0 mA is
recommended for:
1. Patients known to be sensitive to direct current.
2. Sensitive anatomic sites (e.g., fingers, carpal tunnel area, palms, face,
feet).
3. Patients with thin or fragile skin.
C. Start Treatment:
Turn on the ON / DOSE / START knob clockwise one “click” to start treatment.
Current automatically ramps up gradually to desired set point and display shows:
NOTES:
1. “DOSE” shows dose delivered as
mA-minutes accumulate.
2. “TIME” shows time remaining in
minutes and seconds until treatment
is complete. Time calculation is
automatic.
3. “CURRENT” shows actual current
being delivered in mA-minutes.
4. Automatic current ramp includes
built in “comfort pauses.”
IMPORTANT:
If a patient experiences significant discomfort at a current setting of 4.0 mA,
the current may be decreased anytime during the treatment by turning the
CURRENT knob counterclockwise. Treatment time is automatically increased to
achieve the preset dose. For example, if the current is reduced from 4.0 mA to
2.0 mA, the treatment time will automatically double to deliver the preset dose.
TIP:
For manual ramp up: Set dose, then set current below the maximum desired.
Example: Set current at 0.1 mA. Start treatment. Gradually increase current to
desired level, according to patient comfort, by turning CURRENT knob clockwise.
Each “click” increases current 0.1 mA.

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D. Pause or Stop Treatment Manually: During treatment or current ramp
up, turn the CURRENT knob counterclockwise to reduce current output
to 0.0 mA, or press the CURRENT knob for automatic ramp down. The
display will flash “PAUSE”, and the dose delivered prior to the pause is
retained in memory.
EXAMPLE: After decreasing current to 0.0 mA display shows:
NOTES:
1. During a pause, electrodes
may be disconnected, replaced or removed. Dose and/or current
may also be adjusted.
2. To restart the treatment, turn the CURRENT knob clockwise to the
desired current level.
3. Turn the ON/DOSE/START
knob clockwise to start.
The unit will automatically
recalculate the treatment
time, ramp up and
continue treatment.
E. Stop Treatment Automatically: After the preset dose is reached, the
current automatically ramps down to 0.0 mA.
After a 40 mA-minute treatment is complete the unit beeps and the display
shows:
NOTES:
1. After Automatic current ramps down, turn the current knob to
silence the beep, or depress the ON/DOSE/START knob to turn
OFF.
2. Turn CURRENT knob counterclockwise to 0.0 mA anytime to stop
treatment, or depress the ON/DOSE/START knob.
F. After Treatment:
Remove electrodes: Disconnect the lead wire clips and remove the
electrodes from the patient. Discard both the drug electrode and the
dispersive pad. They cannot be reused.

IX. SPECIFICATIONS
Electrical Shock Type BF Applied Part.
Environmental Conditions Transport and store 50°F to 131°F (10°C to 55°C).
Operate 41°F to 104°F (5°C to 40°C). Humidity
less than 90%. Atmospheric pressure from sea
level to 9,842 feet (3,000m)
Ingress of Water Not protected against ingress of water.
Flammability Do not use around flammable gases, liquids or
materials.
Mode of Operation Continuous.
Dimensions 6.1” x 3.5” x 1.9” (15.5 x 8.9 x 4.8cm)
Weight .4 lbs. (.18kg)
Cleaning Clean the case and lead clip wires as needed
with an alcohol moistened cloth. Do not
immerse in fluids.
Disposal Dispose of according to local, state and federal
regulations. Remove battery before disposal.
Controls Two (dose and current)
Dose Range 0 to 80 mA-min.
Maximum Voltage 80V DC
Maximum Current 4.0 mA
Current Ramp Up Automatic (0 to 4.0 mA)Built-in option for
manual override
Current Ramp Down Automatic at end of treatment; paused or turned
off by depressing knob. Built-in option for
manual override
Battery Use only 9V DC Alkaline. Ensure battery door
is in place before starting treatment. Remove
battery from unit when not in use.
Display Dose, Time Remaining, and Current(displayed
simultaneously with interactive set-up)
Pause Feature YES (w/recalculation when restarted)
Visual Indicators Low battery and open circuit
Audible Alerts
Auto Shut-Off
Low battery, open circuit, and end-of treatment
Will automatically shut off after one (1) minute, if
not in use.
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X. TROUBLESHOOTING
Display Shows Possible Cause Corrective Action
“ELECTRODE REJECT”
and“REJ” indicator lights
• Loose electrical connection
at one or both electrodes.
• One or both electrodes have
pulled away from the skin.
• Insufcient medication in
drug electrode.
• Drug electrode not properly
hydrated.
• Medication inappropriate for
iontophoresis.
• Turn CURRENT knob counter-
clockwise to “PAUSE” treat-
ment and silence beep.
• Correct problem.
• Turn CURRENT knob to reset
current. Restart treatment.
Dose “LIMIT”• Maximum dose of 80.0 mA-
min has been reached.
• Refer to electrode directions
for dosage recommenda-
tions.
CAUTION: Do not exceed
recommended dosage.
Current “LIMIT”• Maximum current of 4.0 mA
has been reached.
• Refer to electrode directions
for use and Section VIII-B for
recommendations on current
settings.
“RESISTANCE LIMIT”• Skin resistance at an
electrode site is too high
for preset current level, for
example, the plantar surface
of the foot.
• None. The unit automatically
ramps current up to preset
level, or as high as possible,
and adjusts time to delivered
desired dose.
“PAUSE”• Treatment has been paused
by decreasing current to 0.0
mA, or by depressing the
CURRENT knob.
• During a pause, electrodes
may be disconnected,
moved or replaced.
• Correct situation that caused
treatment to be paused.
• Turn CURRENT knob to reset
current. Restart treatment.
BAT indicator lights
during treatment.
• Battery voltage is decreasing
during treatment but treat-
ment may continue.
• After treatment is nished,
replace battery.
“LOW BATTERY” and “BAT”
indicator lights when unit
is turned on.
• Battery voltage is too low for
proper operation.
• If battery voltage is very low
only BAT indicator lights.
• Unit will not allow treatment
to begin.
• Replace battery.
“LOW BATT REJECT” and
during treatment “BAT” indica-
tor lights.
• Battery voltage is too low for
treatment to continue.
• Unit will not allow treatment
to be restarted.
• Unit ramps down current be-
fore preset dose is delivered.
• Replace battery.

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XI. SERVICE
After following the troubleshooting procedures in section X, if a problem still
exists, call ActivaTek at 801-969-0883. If you must return your ActivaDose® II
Iontophoresis Delivery Unit for inspection or repair, place the unit, along with
the twin lead connector(s), in its original carrying case. Be sure to include a
copy of the Return Materials Authorization (RMA) you received after contact-
ing customer service. No repairs or refunds are performed without an RMA.
Return the unit with postage and insurance prepaid to:
ActivaTek, Inc.
2734 South 3600 West, Unit F
Salt Lake City, UT 84119
USA
800-680-5520
ActivaDose® II Iontophoresis Delivery Unit with Twin Lead

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LIMITED WARRANTY AND DISCLAIMER
ActivaDose® II Iontophoresis Delivery Unit with Twin Lead
I. DISCLAIMER
While in the opinion of ActivaTek, Inc. the use of the ActivaDose® II Ion-
tophoresis Delivery Unit with Twin Lead has met with success in delivering
certain medications into tissues, ActivaTek makes no warranties (i) to the Pur-
chaser as to the effectiveness of the Product in the treatment of any disease
or physiologic dysfunction, or (ii) to Prescribing Physicians that its use will be
effective in the treatment of those patients to whom it is applied.
II. WARRANTY
A. ActivaTek represents and warrants to the Purchaser that the Product
(excluding accessories such as batteries, electrodes, cables and the
component parts thereof) as distributed or manufactured by ActivaTek,
will be free of defects in materials and workmanship for a period of one
(1) year, the “Warranty Period” from the date of purchase.
B. Accessories, including, but not limited to, cables, batteries or electrodes
assemblies are excluded from this warranty since they are designed to
be used over a short period of time.
III. LIMITATION OF LIABILITY
A. ActivaTek’s sole obligation in the case of any breach of its representa-
tion and warranty set forth in Paragraph II, above shall be, without cost
to the Purchaser, to repair or, at ActivaTek’s option, replace the Product
at any time during the warranty period. In the event of a defect in mate-
rials or workmanship, to recover under the warranty, the Purchaser must
return the Product, freight and insurance paid by the Purchaser, within
thirty (30) days of discovery of the defect to:
ActivaTek at
2734 South 3600 West, Unit F
Salt Lake City, UT 84119, USA.
ActivaTek will return the Product, or its replacement, to the Purchaser,
freight and insurance prepaid, not more than ninety (90) days following
its receipt by ActivaTek. Repair or modification of the Product by any
person other than authorized employees or agents of ActivaTek shall
invalidate this warranty. This warranty shall not apply if the Product has
been subjected to misuse, negligence or accident.
B. EXCEPT AS PROVIDED IN PARAGRAPH II. A., THE PRODUCT IS
BEING SOLD ON AN “AS IS” BASIS. THE ENTIRE RISK OF THE
QUALITY AND PERFORMANCE OF THE PRODUCT IS WITH THE
PURCHASER AND ACTIVATEK GIVES NO WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURCHASE,
EITHER EXPRESS OR IMPLIED.
C. ActivaTek shall not be liable for direct, indirect, special, incidental, or
consequential damages, lost profits, or medical expenses caused by any
defect, failure, malfunction or otherwise of the Product, regardless of
the form in which any legal or equitable action may be brought against
ActivaTek (e.g., contract, negligence or otherwise) and the warranty
provided in Paragraph II-A hereof, shall constitute the Purchaser’s sole
remedy. (This warranty gives you specific legal rights and you may have
additional rights which may vary from state to state.)

ActivaTek Inc.
2734 South 3600 West, Unit F
Salt Lake City, Utah 84119 USA
Telephone: [phone]
Toll Free & Fax: [phone]
www.activatekinc.com