Information system software, application program, cardiology

Intended purpose

This device is a cardiology information system whichis intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. This cardiology information system is intended to provide the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison and interpretive 12-lead analysis. This device is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. This cardiology information system is not intended for real-time patient monitoring or for pediatric serial comparison.