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• Children – Keep out of the reach of children.
• Across Chest – Do not apply stimulation across the patient’s chest, because the introduction of electrical current into the chest
may cause rhythm disturbances to the patient’s heart, which could be lethal.
• Across Head – Do not apply stimulation across the patient’s brain, as safety has not been established.
• Pain – Advise the patient to remove electrodes if any undue sensation of pain or burning occurs during the treatment and to
report discomfort to clinic.
• Skin Condition – To establish good contact between the electrodes and skin, excessive hair may be clipped, but DO NOT SHAVE.
Shaving may cause skin breaks that are not readily seen and can increase the risk of adverse skin reactions. Do not apply over
broken or compromised skin (e.g., sunburns, cuts, or acne) due to increased risk of skin reaction.
• Blisters – Small pinhead size blisters may result in response to certain drugs. Contact physician if problem persists longer than 24
hours.
• Skin Reactions – On rare occasions, iontophoresis therapy can result in transient skin reactions such as rash, inflammation and
irritation. These skin reactions may be the result of individual sensitivity to the ionic solution used, the condition of the skin at
the onset of treatment, reaction to the materials in the electrodes, or a poor connection between the electrode and the patient’s
skin. Advise the patient of this possibility before starting treatment. If a visible skin reaction does occur, instruct the patient to
discontinue the treatment and consult the prescribing physician.
• Electromagnetic Interference – Care must be taken when operating this equipment adjacent to or stacked with other
equipment. Potential electromagnetic or other interference could occur to this or to the other equipment. Care should be taken to
minimize this interference by not using other equipment in conjunction with it.
• Flammable Anaesthetics – The system is not suitable for use in the presence of a flammable anaesthetic mixture with air or with
oxygen or nitrous oxide.
• MRI – Do not wear electrode or controller during Magnetic Resonance Imaging (MRI) scans as this may result in metal overheating
and causing skin burns in the area of the patch.
• No modification of this equipment is allowed.
• Potential systemic adverse effects may result from use of this device. Drugs or solutions delivered with this device have the
potential to reach the blood stream and cause systemic effects. Carefully read all labeling of the drug or solution used with this
device to understand all potential adverse effects and to ensure appropriate dosing information. If systemic manifestations occur,
refer to the drug or solution labeling for appropriate action.
WARNINGS
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