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ProMed, LLC

BioScan SudoCheck

Designed for Clinicians by Clinicians.

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BioScan SudoCheck System

SudoCheck System ia a Clinical Powerful Easy To Use Non-Invasive System

In 3-5 Minutes Identify Patients At Risk:
Small nerve fibers are the very first victims of diabetes, which is known to affect the peripheral nervous system even symptoms remain sub-clinical. According to a recent study, already at an early stage of the diabetes evolution, the sympathetic innervation of eccrine sweat glands is progressively reduced. Irrespective of temperature and physical exercise, this alteration of the sweat glands’ autonomous control causes a longlasting shift in the ionic balance of sweat conducts.

* Small unmyelinated C-fibers are responsible for the function of sweat glands

* Sudomotor dysfunction has been established as one of the earliest detectable neurophysiologic abnormalities in distal small fiber neuropathies.

* A quantitative assessment of sweat response is an index of the severity and distribution of automatic failure. It will also serve as an early indicator for the regeneration of small fibers.

* Diabetic patients have been observed to experience a degeneration of small C-fiber innervating sweat glands.

* Measures bio electrochemical sweat skin conductances (BEC) are directly connected to the capability of the glands to transfer chloride ions and which reflects small-C fiber status.

* VitalScan SudoCheck is a fast and easy method to measure sweat function

* 3 minutes or 6 minutes test options.

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Solutions

Precise Evaluations...

VitalScan SudoCheck has been created to enable a precise evaluation of sweat gland function. Based on a measuring method, patients place their hands and feet on stainless-steel electrodes. The method uses low voltage to stimulate the sweat glands and measure the electrochemical reaction between electrodes and chloride ions. This active, new method provides information and evidence of a sweat dysfunction that might otherwise not be detectable in physiological conditions. Bioelectrical Conductances (BEC, in micro siemens, uS) for the hands and feet express the quantitative results, while a risk score derives from demographic data and the BEC values.

The VitalScan SudoCheck system, in accordance with the 21 CFR 882.1540, represents a sympathetic skin response device that provides skin conductance measurements on a computer screen.

VitalScan SudoCheck is, similar to a galvanic skin response stress test, a functional test that measures the sweat glands’ capacity to release chloride ions following an electrochemical stimulation. It works by measuring the electrical potential difference caused by the electrochemical reaction of electrodes, which are applied to the skin and stimulated by a low voltage of variable amplitude. VitalScan SudoCheck comes with 4×2 independent electrodes for placement on feet or palms and other areas with a high number of sweat glands.

VitalScan SudoCheck provides information that determines the cardiometabolic risk in patients.

Solutions

SudoCheck Advantages

Analyze and test SudoCheck’s responsiveness and accuracy in detecting diabetic neuropathy and compare it with existing standardized tests for the diagnosis of diabetic neuropathy.

Evaluate SudoCheck in patients with Diabetes Mellitusm, as an instrument to assess autonomic neuropathy and neuropathic pain.

SudoCheck is an innovative, sensitive tool for the detection of diabetic neuropathy, especially painful diabetic neuropathy. As sweat glands are innervated by small c fibers, which are also involved in pain pathways, precise measuring of the sweat gland function can identify that cause.

SudoCheck, a sensitive device to detect neuropathy in patients with diabetes mellitus, operates with a high sensitivity and specificity.

When compared to non-painful neuropathy, feet BEC was significantly decreased in patients with painful diabetic neuropathy.

When compared to non-painful neuropathy, feet BEC was significantly decreased in patients with painful diabetic neuropathy.

Solutions

Intended Use Is to Diagnose:

For use by general practitioners, pharmacists, cardiologist, neurologist and pain medicine

To assist in the effective screening of cardiometabolic risk in patients

Painful, small fiber neuropathy when nerve conduction test results are normal

Disturbances of the autonomic nervous system which controls the sweat glands, heard, digestive system, other organs, and blood pressure

Complex pain disorders

Diabetic neuropathies

RSD (Reflex Sympathetic Dystrophy)

Dysautonomia

Pharmaceutical agents

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Office: (972) 776-4800

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Office: (972) 776-4800

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