SudoPlus software is designed for managing the data of the sudoPath (galvanic skin response) and the oximeter of TM-Oxi in order to detect the sudomotor dysfunction.
Since the sudomotor function is related to the skin blood flow and autonomic nerve function, the oximeter waveform analysis ( HRV and arterial stiffness assessment) provides significant additional makers in order to properly interpret the galvanic skin response results.
For the description of the oximeter wave form analysis , please click on Oximeter waveform analysis.
The SudoPath system is a programmable electro medical device namely a USB plug and play hardware including and electronic box, cables and reusable electrodes and associated software for the measurement of galvanic skin response.
The background of the SudoPath device is based upon the principles of the electro physiological measurement of the skin related to the microcirculation and innervation of the sweat glands.
The microcirculation and innervation of the sweat glands are controlled by the autonomic nervous system.
The SudoPath measurement process (pending patent) is based on electrically induced sudomotor axon reﬂex test, and provides quantitative evaluation of the skin vasodilation and sweat output responses according to the redox (reduction/oxidation) measurements on the bulk of the electrodes.
The sudomotor response is evaluated at the sole of the feet which have the highest density of eccrine sweat glands and C-fibers that travel the furthest from the brain and the spinal cord.
In order to properly interpret the results , the quantitative sudomotor response is analyzed with markers of the oximeter waveform related to the autonomic nervous system(heart rate variability analysis) and microcirculation (PTG analysis).
Through the protocol communication, the software manages the time and sequence of the electrical stimulation of the receiving electrode and measures the conductance,voltage and latency of the responsive electrode.
The data are stored in the backup system of the software, and the history of the data can be displayed for the same patient with different dates.
Intended use and indications for use
SudoPath is a medical device for the measurement of galvanic skin response.
The SudoPath device provides values. It is the physician's responsibility to make proper judgments based on these numbers.
The device is indicated for use with the general adult population.
Prescription Use Caution: Federal law restricts this device to sale by or on the order of a physician
FDA Clearance 510K number k131568