4
Introduction
GE Healthcare aims to provide you with the best training available and support you in the
clinical use of your Monica Novii Wireless Patch System. This application guide is designed
to provide an overview of Novii as well as provide clinical guidelines of how and when to use
Novii. This application guide is not a substitute for clinical on-site training offered by
GE Healthcare and its representatives. Additional training resources are available at
www.gehealthcare.com/noviitraining
Novii Description
The Monica Novii Pod Fetal-Maternal Monitor is designed as an ambulatory device for the
monitoring of a pregnant mother. The monitor enables the abdominal electrophysiological
signal to be picked up from three different positions on the maternal abdomen using
the 5 electrodes on the Monica Novii Patch. The monitor filters the abdominal signals,
converts the abdominal electrophysiological data into a digital format and then processes
it in real time to extract the fetal heart rate, maternal heart rate and uterine activity.
The result of the processing is transmitted via the Bluetooth connection to the Monica
Novii CTG Interface device that is a Monica Approved accessory to the Monica Novii Pod.
Indications for Use
The Monica Novii Pod 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 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 >36 completed weeks, in labor, 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 the
surface electrodes that attach to the abdomen. 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 CTG Fetal Monitor and sent on to a
central network, if connected. The Novii Pod maternal-fetal monitor and its accessories
are intended for use by healthcare professionals in a clinical setting
Contraindications
The Novii should not be used with antepartum, preterm (≤36 completed weeks)
and multiple pregnancies. In addition, the Novii should not be used with equipment
that introduces electrical energy in to the body i.e., Transcutaneous Electrical Nerve
Stimulation (TENS), cardiac pacemakers, cardiac defibrillators, MRI scanners, CT scanners
and diathermy/electro surgery equipment. Recommend only using Novii with monitoring
systems that have been certified for compatibility for use with Novii by GE Healthcare.
Expectations
Novii provides advanced monitoring for the majority of laboring women, however like
other forms of fetal monitoring, in a small number of women, there may be the need to
switch to a different monitoring method if the FHR signal quality is indicated as poor or
bad. Novii enables in room ambulation and potentially beyond – up to 100ft/30m.
The actual distance of ambulation my vary. Most women are able to walk with good FHR
signal quality, while others may find they will need to modify their activity or position to
allow Novii to work best for them.
Novii Interface
and Pods
Novii Patch
