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The monitor one nDx® is intended to measure time domain heart rate variability (HRV) in response to a series of standardized, controlled exercises on the patient. While the monitor one nDx® has been shown to be safe and effective for the measurement of heart rate variability, it is not intended to be used as the basis for a specific clinical diagnosis. The clinical significance of HRV should be determined by the physician.

monitor one nDx® is a microprocessor based, real-time, hand-held, battery powered, ECG monitor and respiration pacer. It identifies, classifies, analyzes, stores and retrieves from memory electrocardiographic (ECG) signals for the purpose of measuring and providing statistical analysis of heart rate variability. These signals, along with associated numerical data, are provided to the user in printed or electronic form for over-reading by competent medical professionals. The monitor one nDX ® system consists of a pacing and recording device, a set of skin electrodes with associated cable and an optically coupled interface for transmitting stored data to compatible devices or modems. The hand-held monitor weighs 16 oz. and measures 7.5 x 3.5 x 1.4 inches. It is powered by four AA alkaline batteries. monitor one nDx® senses changes in the electrical potential of the skin caused by successive depolarization and repolarization of the heart as it beats. These electrocardiographic (ECG) signals are picked up by electrodes applied to the skin in three locations representing two poles of the V5 lead (recommended) and a reference or "ground" lead. The resulting signal is fed to a series of operational amplifiers, comprising a precision instrumentation amplifier. The signal is conditioned, by means of filters to minimize the effect of noise and artifact. Protection circuits shunt destructive overvoltage to ground to prevent damage to the circuitry.