Wave User Manual v1
Compatible application versions:
v1.0, v1.1, v1.2
Introduction
CergenX Wave is a software as a medical device that uses artificial intelligence (AI) tools to analyse two-channel EEG recordings as an aid in the early detection of abnormal brain activity in newborns with gestational age ≥37 weeks. The device is indicated for use during the first two weeks after birth in cases where there is a concern for neonatal encephalopathy (NE).