Caputron ActivaDose II - Contraindications and Warnings; Contraindications; Never Reuse Single-Use Electrodes; Skin Irritation and Burns

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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.