SudoPlus Software is an optional software accessory.
When used in combination with LD technology cleared devices a) blood pressure device, and/or b) oximeter,and/or c) galvanic skin response device and/or d) bioimpedance analysis device, the SudoPlus Software uploads the data of the devices, and then displays the data onto a computer software for enhanced data management.
The SudoPlus software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical test results of the uploaded data.
SudoPlus software is designed for managing the data of sudoPath and the oximeter of TM-Oxi.
For the description of the TM-Oxi and oximeter features , please click on TM-Oxi system.
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 help in assessment of the sweat gland function.
The background of the SudoPath device is based upon the principles of the electro physiological effects of innervation of the sweat glands related to the skin conductance.
The sweat glands function is related to the autonomic system modulation and perspiration levels.
The SudoPath measurement process (pending patent) is an improved sympathetic skin response method following a constant electrical stimulation, and provides evaluation of the sweat glands function 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.
Through the protocol communication, the software manages the time and sequence of the electrical stimulation of the active receiving electrode and measures the conductance,voltage and latency of the contraleteral passive 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.
Since sudomotor test is only one part of the battery of required tests to assess the autonomic nervous system , the SudoPlus software manages the data of the sudoPath with additional markers such as heart rate variability and phoplethysmography analysis in order to facilitate the interpretation of the sudomotor response results and improve the follow up of the progression of autonomic neuropathy.
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