technical data sheet
Contents
1. The Novii Interface also has a touch screen to allow the user to configure it for connection to different CTG models and has two bays incorporated into its base for charging and pairing of the Novii Pods Performance Specifications Novii Wireless Patch System System Part Number 107 PT O20 7 System Package Novii Interface 107 PT OO1 Oty 1 Novii Interface Power Supply USA 107 PT OO2 US Oty 1 Novii GE CTG Interface Cable 105 P I 102 Novii Oty 1 FHR Round Novii GE CTG Interface Cable MHR 105 PT 104 Novii Oty 1 Novii GE CTG Interface Cable UA 105 PT 106 Novii Oty 1 Novii Pods 107 PT O03 Oly 3 Novii Patch 107 P T004 Oty 2 Novii User Manual CD including 107 PT OO5 Oty 1 Training Videos and Technical Datasheet Part Number 107 PT OO4 107 PT O04 10 107 PT O04 50 Single Patch Box 10 patches Box 50 patches Input 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 120 Dimensions 190mm x 155mm x 12mm including clip IP rating IP57 only when mated to the Novii Pod otherwise IPXO Shelf Life 12 months from Date of Man2. Monca Healthcare Interface midline 2 umbilicus 3 O 0 W Novii Patch is a single use peel and stick disposable part which attaches to the woman s abdomen using the comfortable adhesives 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 HM 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 filters digitises and processes them in real time to extract the FHR MHR amp UA data The pod transmits this data via Bluetooth to the Novii Interface Monitors currently supported include the Corometrics 250 Series Novii Wireless Patch System The Monica Novii Wireless Patch System Novii provides the opportunity to enhance your current Labor and Delivery monitoring experience It connects with your 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 HM Novii Interface is a reusable part that translates Bluetooth data transmitted by the Novii Pod into signals into the correct format input to a standard Corometrics fetal maternal Cardiotocograph CTG monitor The Novii Interface is connected to the CTG monitor via physical cables which attach to the transducer inputs of the CTG monitor
3. artum 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 In the USA the Pod is indicated for Use on women who are at term gt 36 completed weeks in labor with singleton pregnancies using surface electrodes on the maternal abdomen Out side of the USA it is indicated for use from 20 weeks through to delivery in singleton pregnancies 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 NoviiPod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CIG 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 Approvals amp Key Certifications FDA Cleared CE Marked IEC 60601 1 2005 A1 2012 incl Medi
4. cal Electrical Equipment USA deviations Part 1 General requirements for basic safety and essential performance IEC 60601 1 2 2007 Medical Electrical Equipment Part 1 2 General Requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility requirements and tests EN IS014971 2012 Medical Devices Application of risk management to medical devices ISO 14971 2007 Corrected version 2007 10 01 ANSI AAMI EC12 Disposable ECG electrodes EN 62133 2nd Edition 2012 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 EN ISO 10993 Biological evaluation of medical devices FCC CFR 47 Part 15 107 amp 15 109 Title 47 Telecommunication Chapter Federal Communications Commission 15 Radio Frequency devices EN 60529 1992 A2 2013 IP code Specification for degrees of protection provided by enclosures 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 De
5. ed 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 Operating Mode 107 PT OO1 Real Time Continuous Use Data I O Bluetooth Wireless Input Bluetooth v21 EDR Class 1 5 from Novii Interface Protocol Modified Series 5O Range 30m line of sight Output Real Time to CIG fetal monitor via CIG Interface cables comprising e Direct fetal ECG pulse for FHR e MECG pulse for MHR e Uterine Activity waveform for UA User Interfaces 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 Frequency 34kHz O 5kHz Charging Bays 2x wireless Charging bays for Novii Pods with magnetic location Charge Time for 2x fully discharged pods up to 2 hours Facilitate automatic pairing with the Pod Power Supply Input 100 to 240V 5OHZ to 60Hz 400mA Output DV DC 3000mA USA pin out Part Number 10 7 PT 002 US EU pin out Part Number 10 7 PI O02 EU UK pin out Part Number 107 PT OO2 UK Dimensions 152mm x 137mm x 150mm Weight 688g IP rating IPXO Accessories Operating Temperature CTG Connection Cables for GE Corometrics FHR 05 PT 102 Novii MHR 05 PT 104 Novii UA d05 PT 106 Novii 10 C to 430 C Storage Temperature 10 C to 30 C Intended Use The Monica Novii Pod is an intrap
6. ent Difference Ae age 107 cae 1 owe wee pS TTA Hes s lt a Er A 2 MHR Bland Altman vs AN24 predicate 5 32 BPM rms 95 limit of agreement 104 to 10 5 BPM Bias 0 035 BPM Biand Al man Piot of ANH Wa Novi MHA for Al Subjects Combined Uing Delterence is CCO m ee A ji i bd L e r oh oe rer pije 2h I a aa E TE a A S Pemra Sie T ST a T E S ner h De resi S a d a a ri a li 40 Btand ARman Piot of AN24 Vs Novi MHR for Al Subjects Combined Using percent Difference Ae Stage 607 COHERE 5 S 5 ee tere OOF Pert etage RLO pa 198 MR LOA DA 177 M sP 180 Healthcare Monica Healthcare Limited Biocity Pennyfoot Street Nottingham NG11GF Tel 44 115 912 4540 E mail sales monicahealthcare com www monicahealthcare com
7. ufacture Latex amp PVC Free Yes Packaging Individual foil pouches amp transportation cards Operating Temperature HO COTO G Storage Temperature HOC 16450 2 System part numbers for UK and European varaints are available Novii Pod Part Number 107 PT OO3 Operating Mode Real Time Continuous Use Bluetooth Wireless Output Bluetooth v21 EDR Class 1 5 to Novii Interface Protocol Modified Series 5O Range 30m line of sight User Interface LED FHR Range 30 240 BPM Resolution Y4 BPM 4 times second rolling 2 sec average Accuracy Bland Altman vs AN24 predicate 7O8BPM rms 1 MHR Range 40 240 BPM Resolution Y4 BPM 4 times second rolling 2 sec average Accuracy Bland Altman vs AN24 predicate 5 32BPM rms 2 UA Range O 500 microvolts Resolution O 255 levels representing 100 of full scale 4 times second rolling 2 second average Accuracy 9799 percent agreement interpretability 86 05 Positive Percent Agreement Sensitivity Power Battery Rechargeable Lithium Polymer 3 V 75OmAh 80 capacity after 475 charge cycles Battery Life Up to 11 hrs Battery Charging Contactless via the Novii Interface Weight 409 Dimensions 45mm x 39mm x 18mm including contact pins IP rating IP57 only when mated to the Novii Patch otherwise IPXO Accessories Novii Patch 1O7 PT OO4 Operating Temperature t1OC 10 BOC Storage Temperature 10 C to 30 C Type Type BF Equipment appli
8. velopment 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 In the USA the Novii Wireless Patch System is sold exclusively for use with the Corometrics 259cx series fetal maternal Monitor by GE Healthcare Novii and Monica are trademarks of Monica Healthcare Ltd CE 0843 Part No 107 TF 103 UkKrevA 2014 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 Corometrics is a trademark of GE Healthcare 1 FHR Bland Altman vs AN24 predicate 708 BPM rms 95 limit of agreement 13 7 to 41 BPM Bias 0194 BPM Bisnd Abman Pini of AN2 Wa Novi FHR ac oc ae ane man A Ta maA itni ee eer pars Cee wer r prog Ti 2 A pig o a bee perak iI b bpm Femin e MEIG PMen e ore AM i O m Bland Altman Piot of AN24 Vs Novii FHR for AB Subjects Combined Using Perc
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