Patient monitor, cardiotocograph

Intended purpose

The Novii+ Pod is an antepartum and intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii+ Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Pod is indicated for use on women who are at 34 weeks and 0/7 days and greater with singleton pregnancies, using surface electrodes on the maternal abdomen. The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains 5 surface electrodes that attach to the abdomen of a pregnant woman. The Novii+ Interface is an accessory to the Novii+ Pod which provides a means of interfacing the wireless output of the Novii+ Pod to the transducer inputs of a CTG Fetal monitor. The Novii+ Interface enables signals collected by the Novii+ Pod to be printed and displayed on a Maternal/Fetal Monitor and sent on to a central network, if connected.