Indications For Use (FDA)

The CVInsight® Patient Monitoring & Informatics System is composed of a pulse oximeter and a software application installed and operated 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. The CVInsight® Monitoring System measures, displays and stores functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provides alarm functionality for these parameters. Additionally, the CVInsight® Monitoring System provides a utility for recording trends of pulse rate, SpO2 and the percentage of change from a baseline value for values of pulse rate and pulse strength derived from the photoelectric plethysmograph waveform.

 

Intended Use Statement (CE)
The CVInsight system is comprised of a (CE Marked) pulse oximeter and a software application installed and operating on a (Medical Grade) Tablet 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 baseline value for pulse rate and pulse strength derived from the photoplethysmograph waveform. CVInsight provides not-to-exceed threshold values that are set by the user for percentage of change from baseline for pulse rate and pulse strength and event notifications when these values are exceeded.