Appendix E: Pilogel Information - Elitech NANODUCT 1030 User Manual

Appendix E: Pilogel Information

PILOGEL DISCS FOR NANODUCT
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This information also applies to fiber pilocarpine reservoirs when containing pilocarpine solution
supplied by the user.
Proprietary Name:
Pilogel Discs for Nanoduct
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Single Use Only: possible biological contamination; pilocarpine exhaustion.
Composition:
See Appendix D, Critical Components.
Indications:
Pilogel/pilocarpine is used under iontophoresis to induce sweating for sweat analysis for the laboratory
confirmation of a clinical diagnosis of cystic fibrosis.
Contraindications:
• Do not apply to broken or damaged skin surface.
• Do not use on patients that have a known sensitivity or allergy to any ingredient.
Identification:
A translucent off-white gel disc. (Fiber pilocarpine reservoirs are not translucent.)
Side Effects and Special Precautions
The typical and well-known side effects associated with pilocarpine use during iontophoresis onto the
skin are adverse skin reactions. Most individuals that exhibit a sensitivity to pilocarpine experience mild
erythema (redness) of the skin at the electrode locations. In some cases, one or more blister-like welts
may also form. Such "blisters" invariably disappear within 2 to 3 hours, leaving no aftereffects. But, some
patients may also experience skin burns in various degrees. Minor skin burns have been an unwelcome,
adverse side effect of pilocarpine iontophoresis from the beginning of sweat testing with the Gibson and
Cooke method. While the apparent burn rate with the original ELITechGroup Macroduct 3700 system
is less than 1 in 50,000 tests, based on current data and reported events, there have been no reported
burns using Pilogel Discs for Nanoduct and the original Nanoduct system or the Nanoduct 1030. Burn
descriptions vary from "tiny black pinholes in the skin" to "crater-like, third degree burns two to three
millimeters in diameter." In most of the reported incidents, the children have exhibited no sign of pain or
discomfort during iontophoresis, and the burn was not discovered until the electrodes were removed.
ELITechGroup carefully records any side effects reported with its pilocarpine iontophoresis systems.
Consult a physician before performing multiple tests on a patient within a 24-hour period.
Storage Instructions:
Refrigerate at 2 to 8 °C. Do not Freeze. Keep locked up and out of reach of children. (Not applicable to
fiber pilocarpine reservoirs.)
(sold in Supply Kits for Nanoduct)
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