GE Healthcare 6961-MON Novii Intrapartum Maternal/Fetal monitor User Manual 107 TF 100 USrev7 Novii Technical Datasheet

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Document ID	3684198
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Document Description	107-TF-100-USrev7_Novii Technical Datasheet
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Novii Wireless
Patch System
Part of GE Healthcare
The Monica Novii Wireless Patch System (“Novii”)
Interface
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.
Patch
Pod
Novii Patch is a single-use, peel-and-stick disposable
Novii Interface is a reusable part that translates Bluetooth
part, which attaches to the woman’s abdomen using the
data transmitted by the Novii Pod into signals of the correct
comfortable adhesive foam pads. The patch incorporates ECG
format to input your fetal monitor. The Novii Interface is
electrode areas which pick up ECG and EMG signals from the
connected to the CTG monitor via physical cables which
skin surface and then transfer them to the Novii Pod.
attach to the transducer inputs of the CTG monitor. The Novii
Interface also has a touch screen to allow the user to
Novii Pod is a reusable part which magnetically connects to
configure the set-up and has two bays incorporated into its
the Novii Patch to pick up the fetal and maternal ECG and EMG
base for charging and pairing of the Novii Pods.
signals and then filters, 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.
Performance Specifications
Novii Wireless Patch System
System Components*
Novii Interface
107-PT-001
Novii Interface Power Supply (USA)
107-PT-002-US
Novii Interface Power Supply (INT)
107-PT-002
Monica CTG Cables
- GE Corometrics DECG round grey connector
105-PT-102
- GE Corometrics MECG round green connector
105-PT-104
- GE Corometrics UA round white connector
105-PT-106
Novii Pods
107-PT-003
Novii Patch
107-PT-004
Novii User Manual
107-PT-005
Novii User Manual (CD)
100-PT-025
Novii Getting Started Guide
107-PT-006
Novii FHR Gaps Troubleshooting Guide
107-PT-008
3M Red Dot 2236 Skin Prep Tape
100-PT-007
Novii Patch
Part Number
Input
Single Patch
107-PT-004
Box (10 patches)
107-PT-004-10
Box (50 patches)
107-PT-004-50
Electrophysiological signals picked up from the skin surface via the 5
ECG Electrode contact areas integrated into the patch
Output
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
Encryption
Microchip containing factory pre-set code (SHA_256 encryption)
Weight
12g
Dimensions
190mm x 155mm x 12mm (including clip)
IP rating
IP57 only when mated to the Novii Pod, otherwise IP20
Shelf Life
12 months (from Date of Manufacture)
Latex & PVC Free
Yes
Packaging
Individual foil pouches & transportation cards
Operating Temperature
+10°C to +30°C
Storage Temperature
+10°C to +30°C
*Content and quantity can vary by country
Novii Pod
Part Number
107-PT-003
Operating Mode
Real-Time/ Continuous Use
Bluetooth Wireless
Output
Bluetooth v2.1 + EDR, Class 1.5, to Novii Interface
Protocol
Modified Series 50
Range
30m (line of sight)
User Interface
LED
FHR
Range:
60 -240 BPM
Resolution:
¼ BPM, 4 times/ second, rolling 2 sec average
Accuracy:
Bland Altman vs AN24 predicate 7.08BPM rms [1]
Range:
40 -240 BPM
Resolution:
¼ BPM, 4 times/ second, rolling 2 sec average
Accuracy:
Bland Altman vs AN24 predicate 5.32BPM rms [2]
Range:
0 – 500 microvolts
Resolution:
0 – 255 levels representing 100% of full scale, 4
MHR
UA
times/ second, rolling 2 second average
Accuracy:
97.99% percent agreement (interpretability)
86.05% Positive Percent Agreement (Sensitivity)
Power
Battery
Rechargeable Lithium Polymer 3.7V, 750mAh
80% capacity after 475 charge cycles
Battery Life
Up to 11 hrs
Battery Charging
Contactless via the Novii Interface. Charge time for
x2 fully discharged Pods – up to 2 hours
Weight
40g
Dimensions
45mm x 39mm x 20mm (including contact pins)
IP rating
IP57 only when mated to the Novii Patch, otherwise IP20
Accessories
Novii Patch (107-PT-004)
Operating Temperature
+10°C to +30°C
Storage Temperature
+10°C to +30°C
Type
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)
Novii Interface
Part Number
107-PT-001
Operating Mode
Real-Time/ Continuous Use
Data I/O
Bluetooth Wireless
Input
Bluetooth v2.1 + EDR, Class 1.5, from Novii Interface
Protocol
Modified Series 50
Range
30m (line of sight)
Output
Real Time to fetal monitor via Novii Interface
cables, comprising:
User Interfaces
Direct fetal ECG pulse (for FHR)
MECG pulse (for MHR)
Uterine Activity waveform (for UA)
Capacitive Touch
Screen LCD display
Resolution: 800 x 400 (RGB 65K Colors)
Viewing Area: 108mm x 65mm
Touch Panel Durability: 1 Million (tap test)
Alert Buzzer
Charging Bays
Frequency: 3.4kHz ± 0.5kHz
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
Power Supply
Input
100 to 240V~, 50Hz to 60Hz, 400mA
Output
18 W 5V DC, 2500mA
Energy Efficiency
VI
USA pin out
Part Number: 107_PT_002_US
EU, UK, AU pin out
Part Number: 107_PT_002
Dimensions
152mm x 137mm x 150mm
Weight
688g
IP rating
Accessories
Interface Connection Cables for GE Corometrics 174 & 259cx Series
monitor: FHR (105-PT-102); MHR (105-PT-104) UA (105-PT-106). Power
Supply: 107-PT-002_US
Operating Temperature
+10°C to +30°C
Storage Temperature
+10°C to +30°C
Intended Use
The Monica Novii Pod is an intrapartum maternal fetal
The Novii Patch is an accessory to the Novii Pod that
monitor that non invasively measures and displays fetal
connects directly to the Novii Pod and contains the surface
heart rate (FHR), uterine activity (UA) and maternal heart
electrodes that attach to the abdomen.
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
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.
completed weeks), in labor, with singleton pregnancies,
The Novii Pod maternal fetal monitor and its accessories
using surface electrodes on the maternal abdomen.
are intended for use by healthcare professionals.
Approvals & Key Certifications
FDA Cleared
CE Marked
IEC 60601-1:2005 +A1: 2012 incl.
Medical Electrical Equipment
USA deviations
Part 1: General requirements for basic safety and essential performance
EN 60601-1-2:2015/IEC
60601-1-2:2014 (edition 4)
Medical Electrical Equipment
Part 1-2: General Requirements for basic safety and essential
performance – Collateral standard: Electromagnetic compatibility –
requirements and tests
EN ISO14971: 2012
Medical Devices – Application of risk management to medical
devices (ISO 14971:2007, Corrected version 2007-10-01)
ANSI /AAMI EC12-2000-(R)2015
Disposable ECG electrodes
IEC 62133:2017
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
BS EN 10993
Biological evaluation of medical devices
FCC CFR 47: Part 15 Subpart C &
Part 18
FCC CFR 47 Part 15 Subpart C covering the FCC requirements for
ANSI-IEC-60529
Specification for degrees of protection provided by enclosures (IP code)
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
Intentional Radiators, Part 18 Medical Devices
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.
0843
Part No: 107-TF-100-USrev7
© 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
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

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