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The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation of sweat from humans for analysis for the diagnosis of cystic fibrosis.

The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis. 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, collectors, and straps). 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 collection tube of the collector indicate if a sufficient sweat rate is 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.

Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

An iontophoresis device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular wcight of the ion, the strength of the electrical current applied, electrode composition, duration of current flow, and numerous other factors. The IOMED, Inc. RH-950 iontophoresis electrode patch consists of an active delivery electrode and a passive return electrode. These electrodes are designed for a singlepatient, one-application use. This electrode is powered by an on-board 1.5-volt button-cell battery. The maximum allowable electrical current is controlled by means of a fixed in-series resistor included in the device, while the treatment duration is pre-defined and controlled by a printed conductive ink limit switch. The RH-950 iontophoresis electrode consists of dry, monolithic, impregnated polyester nonwoven fabric drug and clectrolyte containment pads designed to be hydrated with aqueous solutions of the drug and electrolyte immediately prior to use. It features a Silver-based metallic conductive current distribution component and a medical-grade pressure sensitive adhesive tape border for skin attachment. All components in contact with the skin are known GRAS materials and/or are listed in the National Formulary.

Northstar System is indicated for the administration of lidocaine hydrochloride to provide local dermal anesthesia on normal intact skin. This system is an alternative to hypodermic injection or topical application of lidocaine hydrochloride. Northstar System is indicated for use on patients 5 years of age and older.

The Northstar Lidocaine Iontophoretic Drug Delivery System (Northstar System) is composed of the Controller and the pre-medicated Patch. The Controller is fitted with a unique interconnect device, mating only with the Northstar Patch. The Northstar System delivers drugs through a process known as iontophoresis. It is based on the principle that a soluble salt or drug can be transported across the skin barrier as a part of an electric current induced in the skin. The quantity and distribution of delivered drug(s) is dependent on; ion charge, molecular weight, the intensity of the electric current and the time the current is present. In most iontophoretic systems the delivery is measured in terms of milliampere-minutes (mA-min). It has been shown that the efficacious delivery of anesthetic levels of lidocaine hydrochloride can be made to local dermal areas through iontophoresis. The Northstar Controller-D uses a combination of discrete analog circuitry to control the delivery current and an embedded microprocessor to monitor the delivery. The Northstar System utilizes a solid-state electronic controller and a pre-medicated drug delivery patch to form a simplified iontophoretic drug delivery system. As a result of this product design coordination, the Northstar System requires no special patch preparation or delivery parameter selection in the controller. An ON button actuation turns on an LCD (Liquid Crystal Display) indicating the number of deliveries available, starts the delivery and two LED's (Light Emitting Diodes) on the controller indicate the delivery status to the user. The Northstar System has been specifically designed for the delivery of a proprietary preparation containing 10.0% Lidocaine hydrochloride and 1.0% Epinepherine packaged in a pre-filled patch. The delivery is done over a 10 minute interval. The user simply applies the patch to the patient, connects the controller and patch then depresses the ON button to start the delivery.

Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular weight of the ion, the strength of the electrical current applied, electrode composition, duration of current flow, and numerous other factors. The RH-900 consists of an active delivery electrode and a passive return electrode. Both electrodes have buffering capability for up to an 80mA-min treatment. These electrodes are designed for a single-patient, one-application use. This electrode is recommended for use with the Phoresor® Iontophoretic Drug Delivery Systems (Iomed, Inc., Salt Lake City, UT 84120). This system is a 9-volt battery powered, solid state, microprocessor-controlled device that controls current levels and duration, calculates total charge delivered and monitors current flow and electrode/skin impedance. The RH-900 electrode consists of a dry, monolithic, impregnated nonwoven polyester fabric liquid containment element designed to be hydrated with an aqueous solution immediately prior to use. It also has a carbon conductive element and an adhesive tape border for skin fixation. All components in contact with the skin are known GRAS materials and/or are listed in the National Formulary.

The Q-Sweat™ Quantitative Sweat Measurement System is designed to measure the sweat output of the skin of humans. This device does not make a diagnosis or indicate by itself that any disease state exists; it simply documents sweat output. This device is to be used in scientific studies of the anatomy, physiology, and biochemistry of the skin & associated structures.

The O-Sweat device is measurement-only device which is designed to measure the rate & volume of sweating by capturing a sample of sweat (water) inside a small measuring chamber which is affixed to the skin. It does not measure any other parameters of the sweat sample. The measurement made is simply a calculation of moisture given off by the skin.

The Iomed, Inc. Phoresor II PM900 is indicated for production of local dermal anesthesia using Iontocaine™ (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).

An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent upon the charge and size (molecular weight) of the ion, the strength of the electrical current being applied, electrode composition, duration of current flow, and numerous other factors. ThePhoresor® II, Model PM900 iontophoretic device is a 9V battery-powered, solid state, microprocessorcontrolled device which controls current strength and duration, calculates total charge delivered, and monitors current flow and electrode/tissue impedance.