GE Healthcare 6961-MON Novii Intrapartum Maternal/Fetal monitor User Manual MH Novii 6pp Brochure 107 TF 102 ENrevA

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Document Description	MH Novii 6pp Brochure -107-TF-102-ENrevA
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Novii
Wireless Patch
System
Improved Maternal
Fetal Monitoring
The Monica Novii Wireless
Patch System provides the
opportunity to enhance
your current monitoring
experience.
It connects with your
maternal/fetal monitor1 and
the data flows seamlessly to
your existing surveillance
and archival system.
Enhanced monitoring
for difficult to monitor
patients
The Monica Novii monitors
fetal heart rate, maternal heart
rate and uterine activity, all
with a single patch. It is an
effective solution for monitoring
high BMI patients (Ref 1, 2) and
minimizes the risk of maternal/
fetal heart rate confusion (Ref
3, 4). In addition, the Patch
requires no repositioning (Ref 4,
8) and the cable-free system
keeps the work environment
clear and safe allowing for
easier monitoring during some
clinical procedures.
Patient satisfaction
The single-patient use Novii
Patch is a completely belt-free,
wireless solution. It allows for
greater freedom of movement
during labour and a more
comfortable experience for the
patient (Ref 7, 8).
“We found Monica
to perform excellently
in very obese women
(35>BMI<60)”
Prof W Cohen,
University of Arizona College of Medicine, Tucson USA
Your Fetal Monitor
The Novii System connects seamlessly
with your monitor1. The Novii Pod,
a small signal-processing and
transmission device, connects effortlessly
using magnets to the ‘peel and stick’
Novii Patch shown below. The Novii
Pod communicates via Bluetooth – no
cables – no belts – no transducers– with
the Novii Interface display device shown
on the left, which connects to your fetal
monitor transducer inputs.
Expanding
maternal/fetal
monitoring
Monitoring High BMI Patients
Picking up consistent, reliable fetal
heart rate and uterine activity can be
challenging on high BMI patients.
Monica Novii monitors the electrical
signals on the patient’s abdomen.
The electrical signals are minimally
effected by adipose tissue and therefore,
the quality of the monitoring is not
compromised by high BMI. Studies,
recruiting women up to a BMI of 60,
have shown minimal loss in FHR and
UA performance as the BMI increases.
(Ref 1, Ref 2).
Contact Monica Healthcare or their authorized representative for a full list
Accuracy
Mobility and Freedom
Monica Novii uses the abdominal fECG
With no cables, belts or transducers
and mECG wave shape to uniquely
and no re-positioning, the Novii System
identify and separate the maternal and
allows real freedom and mobility which
fetal heart rates. The fetal QRS complex
can help the birthing process (Ref 6). The
has a width less than 50% of the maternal
system’s line of sight range of 30m (90
QRS. This and other differences between
feet) allows the patient to move about
the maternal and fetal ECG allow the
the room freely.
Monica Novii to be reasonably certain
that the true FHR has been detected
With no transducer leads between the
(Ref 3, Ref 4).
patient and the fetal monitor, the working
You can be confident that
you are monitoring the fetal heart even
environment around the bed is kept clear
in the most challenging circumstances
and safe. The patient is free to get up
shown below. In addition, the uterine
without asking for assistance.
EMG is used to extract the UA trace and
has been shown in a clinical study to be
equivalent to TOCO UA (Ref 5).
210
180
150
120
90
60
18:50
Scalp FHR
Risk Mitigation
Monica FHR
SpO2 MHR
In a high BMI patient, finding the ideal
Monica UA
transducer placement can be difficult.
IUPC UA
Because the Novii uses electrical signals,
This is data from the multi-centre
it is not impacted by maternal weight.
clinical trial (Ref 1) showing the
This translates into more reliable tracings
FSE FHR, IUPC UA and SpO2
(Ref 1, Ref 2). In addition, the Novii’s ability to
MHR traces used to manage
simultaneously monitor and differentiate
the patient. Superimposed are
the simultaneously monitored
between the fetal and maternal heart rate
Monica UA and FHR. The Monica
can significantly reduce the likelihood of
UA and FHR trace was not seen
maternal/fetal confusion.
by the Doctors and Nurses
managing the patient.
Waterproof
The Monica Novii Patch and Pod,
when connected, are rated for total
water immersion to 1 meter, so they can
be left in place during a bath or shower.
Monitoring continuity cannot be
guaranteed when the Novii Pod is totally
immersed in water.
Patient Friendly
and Convenient
Workflow
Improvements
The Monica Novii is a comfortable
The Novii’s simple, ‘peel and stick’ design
alternative to transducers with belts,
eliminates the need to re-position
which can cause irritation for some
transducers. The single-patient-use patch
patients. The patch only needs to be
minimizes the risk of cross-contamination
placed once, which means that the
caused by inadequate cleaning. In
patient does not need to be disturbed
addition, the system’s ‘intelligent’
for repositioning, and since it is cordless,
automated set-up provides help and
the patient has greater flexibility in
support messages to optimize and
the room.
simplify operation. To prevent Pods
from being lost in operation, they are
Studies have shown (Ref 7,
non-white and the Interface will alert
8) that patient satisfaction
the user if a Pod is not returned to a
is likely to be higher when
charging bay after use.
monitored on the Novii
compared to traditional
transducers. It is light,
small and causes
minimal discomfort.
Long Inductions and Labours
The Novii Interface has two inductive
charging bays allowing two Pods
to be charged at the same time.
The Pod battery life is up to 11 hours,
with up to 2 hours recharging time.
Swapping Pods could not be simpler,
just remove and replace, ensuring
minimal trace loss and the ability to
offer continuity of monitoring over
extended periods.
References
About Monica Healthcare
High BMI:
Ref 1 – Cohen WR, Hayes-Gill B. Influence of maternal body mass index
on accuracy and reliability of external fetal monitoring techniques.
Monica Healthcare is developing a series of innovative wearable
Acta Obstet Gynecol Scand. 2014 Jun ; 93 (6) : 590-5.
devices that uses wireless technologies to facilitate globally
Ref 2 – Graatsma EM, Miller J, Mulder EJ, Harman C, Baschat AA, Visser
GH. Maternal body mass index does not affect performance of fetal
electrocardiography. Am J Perinatol. 2010 Aug ; 27 (7) : 573-7.
accessible obstetric services in the home and hospital.
MHR/FHR Confusion:
Ref 3 – Cohen WR, Ommani S, Hassan S, Mirza FG, Solomon M, Brown
R, Schifrin BS, Himsworth JM, Hayes-Gill BR. Accuracy and reliability
of fetal heart rate monitoring using maternal abdominal surface
electrodes. Acta Obstet Gynecol Scand. 2012 Nov ; 91 (11) : 1306-13.
Ref 4 – Stampalija T, Signaroldi M, Mastroianni C, Rosti E, Signorelli
V, Casati D, Ferrazzi EM. Fetal and maternal heart rate confusion
during intra-partum monitoring: comparison of trans-abdominal fetal
electrocardiogram and Doppler telemetry.
J Matern Fetal Neonatal Med. 2012 Aug ; 25 (8) : 1517-20.
Monica Healthcare Ltd was formed in May 2005 and was the
culmination of 15 years of research at the School of Electrical and
Electronic Engineering and the School of Human Development
at The University of Nottingham, UK.
The patented technology is based on the acquisition of electrophysiological signals that can be passively detected by electrodes
Monica UA Compares with IUPC:
Ref 5 – Hayes-Gill B, Hassan S, Mirza FG, Ommani S, Himsworth J,
Solomon M, Brown R, Schifrin BS, Wayne R. Cohen WR. Accuracy
and Reliability of Uterine Contraction Identification Using Abdominal
Surface Electrodes. Clinical Medicine Insights: Women’s Health 2012 : 5 65–75.
positioned on the maternal abdomen. From these signals a
Mobility and Impact on Stage 1 of Labour:
Ref 6 – Lawrence A, Lewis L, Hofmeyr GJ, Dowswell T, Styles C.
Maternal positions and mobility during first stage labour.
morphology and RR intervals (for research only) can be extracted,
number of parameters, fetal heart rate, maternal heart rate, uterine
activity, maternal movements and parameters describing Fetal ECG
in real time and over an extended period of time.
Cochrane Database Syst Rev. 2009 Apr 15 ; (2) : CD003934.
Patient Satisfaction:
Ref 7 – Reinhard J, Hayes-Gill BR, Yi Q, Hatzmann H, Schiermeier
S. Comparison of non-invasive fetal electrocardiogram to Doppler
cardiotocogram during the 1st stage of labor.
J Perinat Med. 2010 Mar ; 38 (2) : 179-85.
Monica Healthcare is working with business partners to distribute
and deliver professional solutions meeting the needs of modern
obstetric care, risk management and patient satisfaction.
Ref 8 – Rauf Z, O’Brien E, Stampalija T, Ilioniu FP, Lavender T, Alfirevic Z.
Home Labour Induction with Retrievable Prostaglandin Pessary and
Continuous Telemetric Trans-Abdominal Fetal ECG Monitoring.
PLoS ONE 2011 6 (11) : e28129.
In the USA: US law restricts this device to sale by or on the order of a
physician for use in a clinical setting.
The Novii device is for use in singleton term intrapartum patients,
using surface electrodes on the maternal abdomen in a clinical setting.
0843
Part No: 107-TF-102-ENrevA
© Copyright 2015 Monica Healthcare Ltd
All rights reserved
Monica Healthcare reserves the right to make changes to the
features shown herein or discontinue the product described at
any time without notice or obligation and will not be liable for
any consequences resulting from the use of this document.
Monica and Novii are registered trademarks of
Monica Healthcare in USA, EU, China and Japan
Monica Healthcare Limited
Unit 8, Interchange 25 Business Park,
Bostocks Lane,
Nottingham
NG10 5QG UK
Tel: +44 115 9496960
E-mail: sales@monicahealthcare.com
www.monicahealthcare.com
Monica Healthcare Inc.
3862 Brentview Place
Kennesaw
GA 30144
USA
Tel: +1 877 320 5174

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