Patient monitor, cardiac, foetal

Intended purpose

The device is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The device acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the device also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The device is indicated for use on women who are at >36 completed weeks (37.0), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The interface is an accessory to the device which provides a means of interfacing the wireless output of the device to the transducer inputs of a CTG Fetal monitor. The device enables signals collected by the device to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is a maternal-fetal monitor and its accessories are intended for use by healthcare professionals in a clinical setting.