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The Mdoloris Medical Systems SAS HFVI Monitor is intended to acquire, display, and analyze electrocardiographic information and to measure-heart rate variability (HRV). These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.

The Mdoloris Medical Systems SAS (Mdoloris) HFVI Monitor is a heart rate variability monitor intended for use in a medical environment and under the direct supervision of a licensed healthcare practitioner or by personnel specifically trained for its use. The HFVI Sensor acquires electrocardiographic (ECG) signals from the patient, and the Mdoloris HFVI Monitor analyzes the ECG information using a proprietary algorithm that results in the calculation of the High Frequency Variability Index (HFVI). The HFVI is a measure of heart rate variability (HRV), and has a value between 0 and 100. It is intended for use on adult and pediatric patients.