Pain Management > Electrodes

CAUTIONS:

• Federal law (USA) restricts this device to sale by or on the order of a physician.
• Do not exceed a maximum application current for each electrode.
• Before beginning treatment, advise patients that iontophoretic treatment can cause skin irritation or burns.
• Question the patient regarding previous adverse drug reactions. Avoid Iontophoretic application of Ionic Solutions that are known to cause adverse reactions in the patient.

INDICATIONS
Meditrode® is indicated for administration of ionic solutions to a localized area of the body.

CAUTION
During iontophoresis, electrical discharges (sparks) may occur, which could result in flammable material or vapors being ignited.

CONTRAINDICATIONS
Iontophoresis is contraindicated in patients with excessive susceptibility to application of electrical currents, patients with cardiac pacemakers or other electrically sensitive implanted devices, and patients with known sensitivity to the Ionic Solutions to be administered. Iontophoresis is also contraindicated for use over damaged or denuded skin, or over recent scar tissue. It is also contraindicated for application over the thoracic area, across train tissue, or in the orbital region.

PRECAUTIONS

1. DANGER - EXPLOSION HAZARD - DO NOT USE IN PRESENCE OF FLAMMABLE ANESTHETICS.
2. ALWAYS inspect both the drug delivery electrode and the return electrode before applying. Do not use any Meditrode that appears to be damaged or altered in any way, or in which the black conductive sheet is not completely covered by the white absorbent pad. During treatment, never allow the black rubber sheet or the metal snap to come in contact with the patient’s skin.
3. Do not apply Meditrodes over skin that shows any sort of damage. Wherever possible, avoid applying over hair follicles. If necessary, clip the hair in treatment area. DO NOT APPLY OVER AREAS WHERE THE HAIR HAS BEEN SHAVED WITHIN THE PAST 24 HOURS.
4. Meditrodes are designed for single use only. NEVER reuse either the drug delivery electrode or the return electrode, unless labeled “Reusable.” Discard immediately after use.
5. Do not allow the electrode to come in contact with any liquid not indicated for use with the iontophoretic applicator system. If adulteration occurs, discard electrode immediately.
6. Before applying an electrode, read instructions for use located on back of individual patient pak, and also determine whether the patient has:
   1. excessive susceptibility to electrical currents
   2. cardiac pacemaker or other electrically sensitive devices
   3. known sensitivity to the ionic solution to be administered, sodium chloride, or potassium phosphate
      If there is a positive response to any of these questions, iontophoresis should not be used.
7. Before applying an electrode, consult the package insert for the ionic solution being administered for indications, contraindications, and warnings.
8. Iontophoresis can cause skin irritation or burns, and the patient should be advised of this potential before use. Iontophoresis frequently causes transient erythema directly under either the drug delivery electrode or the return electrode in a uniform redness pattern. This redness will normally disappear within 1-3 hours.

   Burns occur occasionally and can be minimized by monitoring the patient’s comfort level and keeping the current at recommended levels. Burns similar to a sunburn may occur over the entire surface of the electrode, or they may occur at punctate areas. The latter are due to defects in the skin, such as broken areas, blocked sweat glands, hair follicles, or nevi. The skin defect tends to carry most of the current, resulting in a high current density at the defect. Whenever possible, application of either electrode over such skin defects should be avoided. If a burn occurs, it may be treated by frequent topical application of an aloe burn gel.

   Rarely, urticaria and/or a rash may occur at the drug delivery electrode and/or return electrode, and this may be due to patient allergy to the drug being delivered. These reactions will usually disappear in several days. An over-the-counter corticosteroid cream may aid in reducing the irritation, and an oral antihistaminic drug may be indicated.

9. Do not exceed the recommended current settings.
10. The current setting should never exceed a comfortable level of the patient. Advise the patient to immediately report any undue burning or pain.
11. Patients with known skin allergies should be treated with extreme caution. Setting should be maintained below sensation level. If blistering of the skin occurs, discontinue use and consult prescribing physician. Avoid any drugs to which the patient is allergic.
12. Follow all contraindications as stated in this package insert.