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The intended use of the HHSsystems QANS (Quantitative Autonomic Nervous System) Monitoring System: OANS (Quantitative Autonomic Nervous System) Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate, and muscle activity) using sensors. The QANS monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data which the clinician can use it make clinical assessments of medical, dental or peak performance interventions. The physiological information can be used as a general patient monitoring system as well as for research. QANS is not intended to produce any interpretation of the measurements obtained and does not provide any type of diagnosis. Patients should be 5 years old or older.

The HHSsystems QANS Monitoring System is the same as that of the Thought Technology devices as the HHSsystems QANS uses the same hardware as the previously cleared ProComp Infiniti, FlexComp Infiniti, ProComp5 and ProComp2 devices with the same BioGraph Infiniti and CardioPro software. This information is contained in 510(k)'s K903497 for the ProComp Infiniti, FlexComp Infiniti, ProComp5 and ProComp2 and in K972723 for the BioGraph Infiniti and CardioPro software. The technology and the method of monitoring heart rate, respiration rate, and muscle activity, are essentially the same as those of the other legally marketed predicate devices. QANS (Quantitative Autonomic Nervous System) Monitoring System is a computer-based system for measurement of Heart Rate Variability (HRV) in response to paced respiration. It is comprised of off-the-shelf Personal Computers (PCs) and special purpose hardware capable of acquiring, storing, analyzing and reporting ECG data from cardiac monitoring devices, respiration rate and muscle activity, using sensors designed to monitor these functions. Data is acquired using the Thought ProComp Infiniti, FlexComp Infiniti, ProComp5 and ProComp2 and in K972723 for the BioGraph Infiniti and CardioPro software. The analysis algorithms identify heart rate variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability. QANS evaluates the variation of the heart rate, both in the time domain (statistical methods) and in the frequency domain (spectral analysis). Each QRS complex (Q, R and S wave deflections on a ECG) detected and the so-called normal-to-normal (NN) or Rate-to-Rate (RR) intervals between adjacent QRS complexes are resulting from sinus node depolarization. The system performs a fully automated quantitative analysis of HRV based on data collected by an FDA-compliant R Wave Trigger device. The system presents the results to the healthcare provider through a computerbased user interface. The system has patient data management capability.