Use Instructions

Product Description

4.1 General description

The Monica Novii Interface is a device that allows a Novii POD to send fetal, maternal and UA

data to the GE Corometrics 259 Series Maternal/Fetal Monitor. The Monica Novii POD is a

wearable, battery-powered device for surveillance of fetal and maternal well-being. The Novii

POD is designed to passively monitor Fetal Heart Rate (FHR), Uterine Activity (UA) and Maternal

Heart Rate (MHR) during pregnancy. The Novii Wireless Patch system is cleared for use from

36 completed week’s gestation for intrapartum use in singleton pregnancies. The Novii POD is

attached via a magnetic clip directly on to the Novii Patch which locates 5 ECG electrodes on

the abdomen of a pregnant woman, using the umbilicus as reference location point (when the

umbilicus has been displaced the midpoint between the fundus and the edge of symphysis pubis

should be used, see Section 6.5.2). The Novii POD then monitors the electrical signals present

at the electrode sites: fetal ECG, maternal ECG and Uterine EMG (Electromyography) plus noise

and interference signals. The acquired signals are then converted by the Novii POD into a digital

format and processed in real-time to extract clinically relevant information, such as Fetal Heart

Rate, Uterine Activity and Maternal Heart Rate.

The Novii POD sends the FHR, UA and MHR data along with maternal movement from the on-

board three axis accelerometer, signal quality and POD battery status signals to the Novii

Interface. This digital data is sent wirelessly via Bluetooth. The Novii Interface receives the

Bluetooth data and converts the FHR, MHR and UA data into an analogue signal before feeding

it to a Maternal/Fetal Monitor via the external DECG (FHR), TOCO (UA) and MECG inputs

(analogue signals). The plugs and cables are specific to the Maternal/Fetal Monitor being

connected. The Maternal/Fetal Monitor will display, print, and connect to a central station the

data from the Novii Interface as if it was acquired from traditional transducers.

The Novii POD has no controls only an LED to indicate when it is on and working. Placing the

POD in a free Novii Interface charging bay that is switched on will allow it to wirelessly connect

with the Novii Interface and for its battery to be charged inductively. The POD will then be

automatically activated when removed from the charging bay. Set-up and operation instructions

are communicated to the user via the Novii Interface display as described in Section 6.

On dispatch the Interface and all PODs making up one Novii Wireless Patch System are

‘locked’ i.e. cannot be used until they have been registered, see Section 5.1.2.

4.2 Data processing

Digital data from the Novii POD is received by the Novii Interface by a Bluetooth wireless

connection; fetal heart rate (FHR), uterine contraction (UA) and maternal heart rate (MHR)

signals are then converted to analogue signals in real-time by the Novii Interface for transfer to