Device Dossier

Patient monitor, cardiotocograph

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

Intended purpose

A cardiotocograph (CTG) that records the feotal heart rate during labour and, at the same time, the uterine contractions. The uterine contractions are usually recorded using a Tocodynamometer which is strapped to the mothers abdomen. This comprises an action plate for a pressure transducer, pressed between the outer retaining bond and the abdomen. The heart rate is measured with an ultrasound transducer.

TGA Public Summary