Use Instructions

monitors uterine activity by measuring the electrical signals (EMG) generated by

the uterine muscle when it contracts, as opposed to the tocodynamometer (TOCO

transducer) which monitors uterine activity as measured by the displacement of a

plunger or button with respect to a guard ring caused by the tightening of the uterus

during a contraction. Small relative changes in the electrode positions used to

monitor the uterine EMG resulting from maternal or fetal movement cause

electrical signals that can look like uterine activity.

CAUTION: The Novii POD when attached to the Novii Patch can remain on the patient while

taking a bath or shower (rated IP57), but monitoring will not work when the woman

is in the bathtub and the POD is fully submerged under water (restricting the

Bluetooth signal) and cannot be guaranteed during a shower. However, the POD

needs to remain attached to the patch while exposed to water to maintain the

integrity of the Patch.

CAUTION: We recommend that the Novii fetal/maternal ECG waveform is not displayed on

Coro 259 series monitor by manually turning this option off. No diagnostic

information can be inferred from waveform sent from Novii Interface to the

Maternal/Fetal Monitor. It is a pulse that can be used by the monitor to accurately

calculate the FHR and MHR.

CAUTION: Only touch the UA zero reference button on the Maternal/Fetal Monitor when

prompted by the Novii Interface at the start of the monitoring. Do not touch the UA

reference button during a monitoring session since it could result in masking

contractions, unless it is confirmed by palpation of the uterus that no contraction is

present.

CAUTION: If the Maternal/Fetal Monitor UA reference button is accidently touched during

monitoring wait until you are confident the woman is not having a contraction (by

using palpation) and then re-touch the UA reference button on the Maternal/Fetal

Monitor.

CAUTION: Any unexpected data from the Novii Interface as shown on the Maternal/Fetal

Monitor display or trace must result in further examination of the mother and fetus

in a hospital environment.

CAUTION: The Novii POD transmits FHR, UA and MHR data to the Maternal/Fetal Monitor

with a short delay of 10 seconds. Data is synchronized allowing accurate

interpretation of decelerations in relation the peak of contractions. Duration of Novii

Wireless Patch contractions can be shorter than mechanical contractions, hence

when palpating the uterus there will be a delay between manual detection of a

contraction and the display of the contraction on the Maternal/Fetal Monitor.