Device Dossier

Patient monitor, cardiotocograph

Device Dossier for Patient monitor, cardiotocograph (Patient monitor, cardiotocograph, Class IIb, sponsor GE Healthcare). ARTG record, intended purpose,…

Intended purpose

This Maternal/Fetal monitor is intended to monitor heart rates (maternal/fetal or twins), maternal uterine contractions, as well as maternal blood pressure and maternal pulse oximetry. Simultaneous trends of heart rate and uterine activity (UA) are plotted continuously using the built-in dual-channel strip chart recorder. All fetal and maternal values are displayed on the front panel LCD display panel.

TGA Public Summary