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APPENDIX A
Pilogel Information
The following information identifies the critical chemicals of each reagent used in this device.
PILOGEL® DISCS (Contained in SS-268 Macroduct Advanced Supply Kit )
Proprietary Name:
Pilogel® Discs
Single Use Only: possible biological contamination; pilocarpine exhaustion.
For areas in which Pilogel discs are not available, operators should check with ELITechGroup for
the availability of fiber pilocarpine reservoirs of the same size as Pilogel discs, for use with
pilocarpine solutions supplied by the operator. Unless otherwise indicated, any mention of Pilogel
discs in this manual applies equally to the fiber pilocarpine discs.
Indications:
Pilogel/pilocarpine is used under iontophoresis to induce sweating for sweat analysis for the
laboratory confirmation of a physician’s 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:
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 and minor burns. Based on current data and reported events,
the incidence of such skin burns is very rare (less than 1 in 50,000 tested patients). See Section 3.4
Risk of Burns.
Consult a physician before performing multiple tests on a patient within a 24-hour period.
Storage Instructions:
Refrigerate at 2 °C to 10 °C. Do not Freeze. Keep locked up and out of reach of children.
Registration Number:
SS-268
Name and Business Address of Manufacturer:
ELITechGroup Inc.
Biomedical Systems
370 West 1700 South
Logan, Utah 84321-8212
USA
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