GE Healthcare 6960-MON Novii Intrapartum Maternal/Fetal monitor Pod User Manual MH Novii 6pp Brochure 107 TF 102 ENrevA

GE Healthcare Novii Intrapartum Maternal/Fetal monitor Pod MH Novii 6pp Brochure 107 TF 102 ENrevA

MH Novii 6pp Brochure -107-TF-102-ENrevA

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 lows seamlessly to
your existing surveillance
and archival system.
Enhanced monitoring
for diicult to monitor
patients
The Monica Novii monitors
fetal heart rate, maternal heart
rate and uterine activity, all
with a single patch. It is an
eective 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 eortlessly
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.
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
eected 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).
Expanding
maternal/fetal
monitoring
1 Contact Monica Healthcare or their authorized representative for a full list
Mobility and Freedom
With no cables, belts or transducers
and no re-positioning, the Novii System
allows real freedom and mobility which
can help the birthing process (Ref 6). The
system’s line of sight range of 30m (90
feet) allows the patient to move about
the room freely.
With no transducer leads between the
patient and the fetal monitor, the working
environment around the bed is kept clear
and safe. The patient is free to get up
without asking for assistance.
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.
210
180
150
120
90
60
18:50
Risk Mitigation
In a high BMI patient, inding the ideal
transducer placement can be diicult.
Because the Novii uses electrical signals,
it is not impacted by maternal weight.
This translates into more reliable tracings
(Ref 1, Ref 2). In addition, the Novii’s ability to
simultaneously monitor and dierentiate
between the fetal and maternal heart rate
can signiicantly reduce the likelihood of
maternal/fetal confusion.
Accuracy
Monica Novii uses the abdominal fECG
and mECG wave shape to uniquely
identify and separate the maternal and
fetal heart rates. The fetal QRS complex
has a width less than 50% of the maternal
QRS. This and other dierences between
the maternal and fetal ECG allow the
Monica Novii to be reasonably certain
that the true FHR has been detected
(Ref 3, Ref 4). You can be conident that
you are monitoring the fetal heart even
in the most challenging circumstances
shown below. In addition, the uterine
EMG is used to extract the UA trace and
has been shown in a clinical study to be
equivalent to TOCO UA (Ref 5).
Scalp FHR
Monica FHR
SpO2 MHR
Monica UA
IUPC UA
This is data from the multi-centre
clinical trial (Ref 1) showing the
FSE FHR, IUPC UA and SpO2
MHR traces used to manage
the patient. Superimposed are
the simultaneously monitored
Monica UA and FHR. The Monica
UA and FHR trace was not seen
by the Doctors and Nurses
managing the patient.
Worklow
Improvements
The Novii’s simple, ‘peel and stick’ design
eliminates the need to re-position
transducers. The single-patient-use patch
minimizes the risk of cross-contamination
caused by inadequate cleaning. In
addition, the system’s ‘intelligent’
automated set-up provides help and
support messages to optimize and
simplify operation. To prevent Pods
from being lost in operation, they are
non-white and the Interface will alert
the user if a Pod is not returned to a
charging bay after use.
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
oer continuity of monitoring over
extended periods.
Patient Friendly
and Convenient
The Monica Novii is a comfortable
alternative to transducers with belts,
which can cause irritation for some
patients. The patch only needs to be
placed once, which means that the
patient does not need to be disturbed
for repositioning, and since it is cordless,
the patient has greater lexibility in
the room.
Studies have shown (Ref 7,
8) that patient satisfaction
is likely to be higher when
monitored on the Novii
compared to traditional
transducers. It is light,
small and causes
minimal discomfort.
About Monica Healthcare
Monica Healthcare is developing a series of innovative wearable
devices that uses wireless technologies to facilitate globally
accessible obstetric services in the home and hospital.
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 electro-
physiological signals that can be passively detected by electrodes
positioned on the maternal abdomen. From these signals a
number of parameters, fetal heart rate, maternal heart rate, uterine
activity, maternal movements and parameters describing Fetal ECG
morphology and RR intervals (for research only) can be extracted,
in real time and over an extended period of time.
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.
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 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
References
High BMI:
Ref 1 – Cohen WR, Hayes-Gill B. Inluence of maternal body mass index
on accuracy and reliability of external fetal monitoring techniques.
Acta Obstet Gynecol Scand. 2014 Jun ; 93 (6) : 590-5.
Ref 2 – Graatsma EM, Miller J, Mulder EJ, Harman C, Baschat AA, Visser
GH. Maternal body mass index does not aect performance of fetal
electrocardiography. Am J Perinatol. 2010 Aug ; 27 (7) : 573-7.
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 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 Identiication Using Abdominal
Surface Electrodes. Clinical Medicine Insights: Women’s Health 2012 : 5 65–75.
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 irst stage labour.
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.
Ref 8 – Rauf Z, O’Brien E, Stampalija T, Ilioniu FP, Lavender T, Alirevic 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.
Monica and Novii are registered trademarks of
Monica Healthcare in USA, EU, China and Japan
Monica Healthcare Inc.
3862 Brentview Place
Kennesaw
GA 30144
USA
Tel: +1 877 320 5174

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