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The VENDYS Model 6000 Model B/BC is a non-invasive digital temperature monitoring device. The device provides continuous monitoring of body surface temperature at multiple sites simultaneously (e.g. fingertips on the study and control hands). It is intended to use for measurement of vascular reactivity by monitoring temperature changes before, during, and after a reactive hyperemia test using a 2-5 minute cuff occlusion procedure.

The VENDYS Model 6000 Model B/BC is a non-invasive digital temperature monitoring device. The device provides continuous monitoring of body surface temperature at multiple sites simultaneously (e.g. fingertips on the study and control hands).

The VENDYS Model 5000 B/BC is a non-invasive, digital temperature monitoring device. The device provides continuous monitoring of body surface temperature at multiple sites simultaneously (e.g. fingertips on the study and control hands). It is intended to use for measurement of vascular reactivity by monitoring temperature changes before, during and after a reactive hyperemia test using a 2-5 minute cuff occlusion procedure.

The VENDYS Model 5000 B/BC is a non-invasive, Programmable Diagnostic Computer device capable of providing digital thermal monitoring of multiple digits that can aid in studies of vascular function and evaluation of future cardiovascular risk. The device provides continuous and simultaneous monitoring of skin surface temperature at multiple digits (e.g. fingertips on the study and control hands). It displays temperature changes before, during and after a reactive hyperemia procedure, and calculates multiple indices based on temperature changes. The surface temperature signal (1 or 2 channels) is recorded at the digit (e.g. fingertip) and processed in the Vendys Model 5000 B electronics module. The signal processing electronics module (Vendys Model 5000 B) is attached to a PC computer via a standard USB cable through a USB port. The Vendys Data Acquisition and Analysis software is necessary to calculate, display, and archive the test data and is intended to be loaded on an IBM-compatible computer (notebook or desktop). The Vendys software records the signals from the Vendys Model 5000 B electronics module, displays a plot of the temperature response before, during and after a reactive hyperemia procedure, and calculates multiple indices based on temperature changes. These temperature indices and the temperature plot are further explained in Section 12 of the submission. The Vendys software program also allows user input of other pertinent patient information and provides the operator with instructions for use.