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SECTION 1: INTRODUCTION
1.1 Device Overview
Functional Description
Macroduct Advanced Sweat Collection System is intended for laboratory use by qualified
personnel for stimulation and collection of sweat from humans to assist in the laboratory
diagnosis of cystic fibrosis.
The system safely and efficiently accomplishes the stimulation of human sweat through
pilocarpine iontophoresis using the Macroduct Advanced Model 3710. The Macroduct Advanced
Sweat Collector collects a sample of the stimulated sweat. Markings on the tube indicate if a
sufficient sweat rate was achieved during the collection of sweat. The sample can then be
analyzed for indications of cystic fibrosis with the Sweat-Chek™ Sweat Conductivity Analyzer using
the principle of total electrolyte concentration in the sweat sample; or with the ChloroChek®
Chloridometer® using the principle of coulometric titration.
The Macroduct Advanced Sweat Collection System consists of the Macroduct Advanced Model
3710, which is a microprocessor-controlled device powered from a rechargeable lithium-ion
battery, battery charging power supply and cord for charging the battery, electrode cable
assembly, and a kit of single-use supplies (Pilogel discs and collectors). The Macroduct Advanced
Model 3710 automates and controls the sweat collection process used to detect cystic fibrosis. In
that sweat collection process, pilocarpine ions are ‘pushed’ into the sweat glands of the skin by a
small electric current (1.5 mA DC) where they stimulate sweat in the same way as the chemicals
released by the brain to control body heat through sweating on a hot day. After sweating has
been stimulated in a particular area, the electrodes are removed and the skin is cleaned. A plastic
Macroduct Advanced Sweat Collector is strapped to the stimulated area so that the emerging
sweat is directed into plastic tubing coiled on the surface of the collector. The pure sweat
collected in this tubing may be analyzed by methods that are compatible with the sample volume.
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