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The CVInsight system is comprised of a pulse oximeter and a software application installed and operating on a personal computer. The pulse oximeter device is indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spot-checking and / or data collection and recording of patients who are well or poorly perfused. The intended use environments are Hospitals, Medical Facilities, Ambulatory, Sub-Acute, and Sleep Studies. CVInsight measures, displays, and stores functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provides alarm functionality for these parameters. Additionally, CVInsight provides a utility for recording trends of pulse rate, SpO2, and the percentage of change from a user-defined baseline value for values of pulse rate and pulse strength derived from the photoelectric plethysmograph waveform.

The CVInsight system is comprised of a cleared pulse oximeter and software application operating on a personal computer and is intended to be a non-invasive tool in the physiological monitoring of adult and pediatric patients. CVInsight wirelessly acquires and displays measures of pulse rate, functional oxygen saturation of arterial hemoglobin (SpO2), and provides alarm functionality for these parameters. CVInsight provides factory default values or optional clinician determined threshold values in which triggers alarm conditions during CVInsight operation. The device calculates percentage of change from a baseline value for the pulse strength values derived from the photoelectric plethysmograph waveform and graphically displays these values over time. The device also provides event indications based upon threshold values input by the clinician. This device is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. The device does not report any diagnosis but provides spot-checking and trending data only. It is the clinician's responsibility to make proper decisions based upon their experience and training.