Indications for Use (FDA) for Forehead Sensor/Contact Product

The CVInsight® Patient Monitoring & Informatics 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. 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 user-defined baseline value for values of pulse rate and pulse strength derived from the photoelectric plethysmograph waveform.

 

Note: The “Non-Contact” product embodiment is in FDA pre-submission. This mCVITM product is not yet available for commercial sale.

CVInsight® Patient Monitoring & Informatics System is a registered trademark of InteloMed, Inc.