Wave User Manual v2
Latest version
Compatible application versions:
v1.4, v1.5
This version includes a safety update
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).
Warning / Caution | Users should pay particular attention to warning/caution information. Disregarding this information may compromise the safety of the patient and/or health care staff and may impact product reliability. |
Note | Information supplements and or clarification of procedure or device operation |
Warnings
CergenX Wave should not be used as the sole basis for diagnosis. The output should not be considered as a definitive diagnosis. CergenX Wave should only be used in conjunction with other clinical assessments as per the standard of care. |
Home Page
