Introduction

VitalScan SudoCheck+ has been created to enable a precise evaluation of sweat gland function. It is based on a measuring method, whereas patients place their hands and feet on stainless-steel electrodes and are exposed to an incremental low direct voltage - lower than 4 V - that is released in intervals of two minutes. What is being tested is the electrochemical reaction between electrodes and chloride of the, through low voltage stimulated sweat glands. 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 microsiemens, uS) for the hands and feet, express the quantitative results, while a risk score is derived from demographic data and the BEC values.

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

 

VitalScan SudoCheck+ is, similar to a galvanic skin response stress test, an active 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 are stimulated by a low voltage of variable amplitude.

 

VitalScan SudoCheck+ comes with 5 independent electrodes for placement on the body, for example, feet or palms and other areas with a high number of sweat glands.

VitalScan SudoCheck+ provides information that determines the cardiometabolic risk in patients. The test, equivalent to a galvanic skin response stress test, measures the sweat glands' capacity to release chloride ions in response to an electrochemical activation.
The advantages: VitalScan SudoCheck+ does not require any patient preparation, such as blood drawing or fasting; it is non-invasive and delivers immediate results, with findings

at are ready to use after a short and uncomplicated test of merely 2 minutes.
VitalScan SudoCheck+ has been developed for use by general practitioners, pharmacists, cardiologists, and neurologists to assist in the effective screening of cardiometabolic risk in patients.

Analytical Overview

* 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.
* As an index of the severity and distribution of automatic failure, quantitative assessment of sweat response has been proposed. It will also serve as an early indicator for regeneration of small fibers.
* Diabetic patients have been observed to experience a degeneration of small C-fiber innervating sweat glands
* VitalScan SudoCheck+ measures bioelectrochemical sweat skin conductances (BEC), which 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.

Advantages

* Analyze and test VitalScan SudoCheck+ responsiveness and accuracy in detecting diabetic neuropathy and compare it with existing standardized tests for the diagnosis of diabetic neuropathy.
* Evaluate VitalScan SudoCheck+ in patients with Diabetes Mellitusm, as an instrument to assess autonomic neuropathy and neuropathic pain.
* VitalScan 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.
* VitalScan SudoCheck+, a sensitive device to detect neuropathy in patients with diabetes mellitus.
* When compared to non-painful neuropathy, feet BEC was significantly decreased in patients with painful diabetic neuropathy.
* These results suggest that the peripheral autonomic nervous system plays a role in painful diabetic neuropathy.
* VitalScan SudoCheck+ results correlated significantly with clinical neuropathy scores, pain scores, and measures of autonomic dysfunction.

 

Features

* Quantitative Sudomotor Axon Reflex Test (QSART)
* Sympathetic Skin Response (SSR)
* Sudomotor sympathetic response
* Bioelectric Impedance Analysis (BIA)
* Body Composition Analyse
* Electro Interstitial Scan (EIS)
* Electrical Dispersion Analysis (EDA)
* Easy-to-use intuitive colorful graphical user interface
* Backed by 30 years of documented medical studies
* Easy software installation and automatic hardware detection
* Supported Languages: English, Spanish, Italian, German, Chinese, Japanese, French