GE Healthcare 6961-MON Novii Intrapartum Maternal/Fetal monitor User Manual 107 TF 100 USrev7 Novii Technical Datasheet
GE Healthcare Novii Intrapartum Maternal/Fetal monitor 107 TF 100 USrev7 Novii Technical Datasheet
Contents
107-TF-100-USrev7_Novii Technical Datasheet
Part of GE Healthcare
Novii Wireless
Patch System
The Monica Novii Wireless Patch System (“Novii”)
provides the opportunity to empower you and your
patients by enhancing patient comfort & optimizing
your workflow. It connects with your Corometrics 174
and 259cx series maternal/fetal monitors and the data
flows seamlessly to your existing surveillance and
archival system.
Novii has three constituent parts, the Novii
Patch, Novii Pod and Novii Interface.
Novii Interface is a reusable part that translates Bluetooth
data transmitted by the Novii Pod into signals of the correct
format to input your fetal monitor. The Novii Interface is
connected to the CTG monitor via physical cables which
attach to the transducer inputs of the CTG monitor. The Novii
Interface also has a touch screen to allow the user to
conigure the set-up and has two bays incorporated into its
base for charging and pairing of the Novii Pods.
Novii Patch is a single-use, peel-and-stick disposable
part, which attaches to the woman’s abdomen using the
comfortable adhesive foam pads. The patch incorporates ECG
electrode areas which pick up ECG and EMG signals from the
skin surface and then transfer them to the Novii Pod.
Novii Pod is a reusable part which magnetically connects to
the Novii Patch to pick up the fetal and maternal ECG and EMG
signals and then ilters, digitises and processes them in real
time to extract the FHR, MHR & UA data. The Pod transmits
this data via Bluetooth to the Novii Interface.
Patch
Pod
Interface
Performance Speciications
Novii Wireless Patch System
System Components* Novii Interface
Novii Interface Power Supply (USA)
Novii Interface Power Supply (INT)
Monica CTG Cables
- GE Corometrics DECG round grey connector
- GE Corometrics MECG round green connector
- GE Corometrics UA round white connector
107PT001
107PT002-US
105PT102
105PT104
105PT106
107PT003
107PT004
100PT025
Novii Patch
Part Number
Input
Output
Encryption
Weight
Dimensions
IP rating
Shelf Life
Latex & PVC Free
Packaging
Operating Temperature
Storage Temperature
Novii Pods
Novii Patch
Novii User Manual
Novii User Manual (CD)
Novii Getting Started Guide
Novii FHR Gaps Troubleshooting Guide
3M Red Dot 2236 Skin Prep Tape
Single Patch
Box (10 patches)
Box (50 patches)
Electrophysiological signals picked up from the skin surface via the 5
ECG Electrode contact areas integrated into the patch
Electrical signals collected in a central area for input to the Novii Pod. The
patch is passive, but converts the electrophysiological signals on the
body into electronic signals for the Novii Pod
Microchip containing factory pre-set code (SHA_256 encryption)
12g
190mm x 155mm x 12mm (including clip)
IP57 only when mated to the Novii Pod, otherwise IP20
12 months (from Date of Manufacture)
Yes
Individual foil pouches & transportation cards
+10°C to +30°C
+10°C to +30°C
107PT004
107PT004-10
107PT004-50
107PT006
107-PT-008
100-PT-007
107PT005
*Content and quantity can vary by country
107PT002
Novii Pod
Part Number
Operating Mode
Bluetooth Wireless
User Interface
FHR
MHR
UA
Power
Weight
Dimensions
IP rating
Accessories
Operating Temperature
Storage Temperature
Type
107PT003
Real-Time/ Continuous Use
Output
Protocol
Range
LED
Range:
Resolution:
Accuracy:
Range:
Resolution:
Accuracy:
Range:
Resolution:
Accuracy:
Battery
Battery Life
Battery Charging
40g
45mm x 39mm x 20mm (including contact pins)
IP57 only when mated to the Novii Patch, otherwise IP20
Novii Patch (107PT004)
+10°C to +30°C
+10°C to +30°C
Type BF Equipment (applied part is the Novii patch, which connects
to the pod via the spring contact pins at the bottom of the pod)
Bluetooth v2.1 + EDR, Class 1.5, to Novii Interface
Modiied Series 50
30m (line of sight)
60 -240 BPM
¼ BPM, 4 times/ second, rolling 2 sec average
Bland Altman vs AN24 predicate 7.08BPM rms [1]
40 -240 BPM
¼ BPM, 4 times/ second, rolling 2 sec average
Bland Altman vs AN24 predicate 5.32BPM rms [2]
0 – 500 microvolts
0 – 255 levels representing 100% of full scale, 4
times/ second, rolling 2 second average
97.99% percent agreement (interpretability)
86.05% Positive Percent Agreement (Sensitivity)
Rechargeable Lithium Polymer 3.7V, 750mAh
80% capacity after 475 charge cycles
Up to 11 hrs
Contactless via the Novii Interface. Charge time for
x2 fully discharged Pods – up to 2 hours
Novii Interface
Part Number
Operating Mode
Data I/O
User Interfaces
Charging Bays
Power Supply
Dimensions
Weight
IP rating
Accessories
Operating Temperature
Storage Temperature
107PT001
Real-Time/ Continuous Use
Bluetooth Wireless
Input
Protocol
Range
Output
Capacitive Touch
Screen LCD display
Alert Buzzer
2x wireless charging bays for Novii Pods (with magnetic location)
Charge Time for 2x fully discharged pods - up to 2 hours uses
IrDA to facilitate automatic pairing with the Pod
Input
Output
Energy Efficiency
USA pin out
EU, UK, AU pin out
152mm x 137mm x 150mm
688g
IP20
Interface Connection Cables for GE Corometrics 174 & 259cx Series
monitor: FHR (105PT102); MHR (105PT104) UA (105PT106). Power
Supply: 107PT002_US
+10°C to +30°C
+10°C to +30°C
Bluetooth v2.1 + EDR, Class 1.5, from Novii Interface
Modiied Series 50
30m (line of sight)
Real Time to fetal monitor via Novii Interface
cables, comprising:
lDirect fetal ECG pulse (for FHR)
lMECG pulse (for MHR)
lUterine Activity waveform (for UA)
Resolution: 800 x 400 (RGB 65K Colors)
Viewing Area: 108mm x 65mm
Touch Panel Durability: 1 Million (tap test)
Frequency: 3.4kHz ± 0.5kHz
100 to 240V~, 50Hz to 60Hz, 400mA
18 W 5V DC, 2500mA
VI
Part Number: 107_PT_002_US
Part Number: 107_PT_002
Approvals & Key Certiications
FDA Cleared
CE Marked
IEC 60601-1:2005 +A1: 2012 incl.
USA deviations
EN 60601-1-2:2015/IEC
60601-1-2:2014 (edition 4)
EN ISO14971: 2012
ANSI /AAMI EC12-2000-(R)2015
IEC 62133:2017
BS EN 10993
FCC CFR 47: Part 15 Subpart C &
Part 18
ANSI-IEC-60529
Medical Electrical Equipment
Part 1: General requirements for basic safety and essential performance
Medical Electrical Equipment
Part 12: General Requirements for basic safety and essential
performance – Collateral standard: Electromagnetic compatibility –
requirements and tests
Medical Devices – Application of risk management to medical
devices (ISO 14971:2007, Corrected version 20071001)
Disposable ECG electrodes
Secondary cells and batteries containing alkaline or other non-acid
electrolytes – Safety requirements for portable sealed secondary
cells, and for batteries made from them, for use in portable
applications
Biological evaluation of medical devices
FCC CFR 47 Part 15 Subpart C covering the FCC requirements for
Intentional Radiators, Part 18 Medical Devices
Speciication for degrees of protection provided by enclosures (IP code)
Intended 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 term (>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 the Fetal monitor.
The Novii Interface enables signals collected by the Novii
Pod to be printed and displayed on the 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.
EN 62479:2010 Assessment of the compliance of low power electronic and electrical
equipment. (SAR)
EN 61000-3 parts 2 & 3
Limits: Emission limits, Immunity limits
Monica Healthcare Limited
Unit 8, Interchange 25 Business Park,
Bostocks Lane,
Nottingham, NG10 5QG, UK
Tel: +44 115 949 6960
E-mail: novii.info@ge.com
www.monicahealthcare.com
About Monica Healthcare
With over 25 years of research, expert knowledge and collaborations with leading hospitals, Monica Healthcare has developed an
advanced electrophysiological technology to produce fetal monitors that are beneficial for midwives, L&D nurses and expectant
women.
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
and maternal movements can be extracted, in real time, and over an extended period of time.
Monica Healthcare is part of the Maternal Infant Care solutions offered by GE Healthcare. Through GE Healthcare’s global network,
the Novii Wireless Patch system will help to improve maternal and infant care worldwide.
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Part No: 107TF100USrev7
© 2016 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.
Novii and Monica are registered trademarks of Monica Healthcare
in the USA, EU, China and Japan.
JB30822US(7)
Part of GE Healthcare