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

107-TF-100-USrev7_Novii Technical Datasheet

Part of GE HealthcareNovii Wireless Patch SystemThe 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 conigure 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 PodInterface
Performance SpeciicationsNovii Wireless Patch SystemSystem 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 connector107PT001107PT002-US105PT102105PT104105PT106107PT003107PT004100PT025Novii PatchPart NumberInputOutputEncryptionWeightDimensionsIP ratingShelf LifeLatex & PVC FreePackagingOperating TemperatureStorage TemperatureNovii PodsNovii PatchNovii User Manual Novii User Manual (CD)Novii Getting Started GuideNovii FHR Gaps Troubleshooting Guide 3M Red Dot 2236 Skin Prep TapeSingle PatchBox (10 patches)Box (50 patches)Electrophysiological signals picked up from the skin surface via the 5 ECG Electrode contact areas integrated into the patchElectrical 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 PodMicrochip containing factory pre-set code (SHA_256 encryption)12g190mm x 155mm x 12mm (including clip)IP57 only when mated to the Novii Pod, otherwise IP2012 months (from Date of Manufacture)YesIndividual foil pouches & transportation cards+10°C to +30°C+10°C to +30°C107PT004107PT004-10107PT004-50107PT006107-PT-008100-PT-007107PT005*Content and quantity can vary by country 107PT002
Novii PodPart NumberOperating ModeBluetooth WirelessUser InterfaceFHRMHRUAPower WeightDimensionsIP ratingAccessoriesOperating TemperatureStorage TemperatureType107PT003Real-Time/ Continuous UseOutput ProtocolRange LEDRange:Resolution:Accuracy:Range:Resolution:Accuracy:Range:Resolution:Accuracy:BatteryBattery LifeBattery Charging40g45mm x 39mm x 20mm (including contact pins)IP57 only when mated to the Novii Patch, otherwise IP20Novii Patch (107PT004)+10°C to +30°C+10°C to +30°CType 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 InterfaceModiied Series 50 30m (line of sight) 60 -240 BPM ¼ BPM, 4 times/ second, rolling 2 sec averageBland Altman vs AN24 predicate 7.08BPM rms [1] 40 -240 BPM ¼ BPM, 4 times/ second, rolling 2 sec averageBland Altman vs AN24 predicate 5.32BPM rms [2]0 – 500 microvolts0 – 255 levels representing 100% of full scale, 4 times/ second, rolling 2 second average97.99% percent agreement (interpretability) 86.05% Positive Percent Agreement (Sensitivity)Rechargeable Lithium Polymer 3.7V, 750mAh80% capacity after 475 charge cyclesUp to 11 hrsContactless via the Novii Interface. Charge time for x2 fully discharged Pods – up to 2 hours
Novii InterfacePart NumberOperating ModeData I/OUser InterfacesCharging BaysPower SupplyDimensionsWeightIP ratingAccessoriesOperating TemperatureStorage Temperature107PT001Real-Time/ Continuous UseBluetooth WirelessInput ProtocolRange OutputCapacitive Touch Screen LCD displayAlert Buzzer2x wireless charging bays for Novii Pods (with magnetic location)Charge Time for 2x fully discharged pods - up to 2 hours usesIrDA to facilitate automatic pairing with the PodInputOutputEnergy EfficiencyUSA pin outEU, UK, AU pin out152mm x 137mm x 150mm688g IP20 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+10°C to +30°C+10°C to +30°CBluetooth v2.1 + EDR, Class 1.5, from Novii InterfaceModiied 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 65mmTouch Panel Durability: 1 Million (tap test)Frequency: 3.4kHz ± 0.5kHz100 to 240V~, 50Hz to 60Hz, 400mA 18 W 5V DC, 2500mAVIPart Number: 107_PT_002_USPart Number: 107_PT_002
Approvals & Key CertiicationsFDA ClearedCE MarkedIEC 60601-1:2005 +A1: 2012 incl. USA deviationsEN 60601-1-2:2015/IEC 60601-1-2:2014 (edition 4)EN ISO14971: 2012ANSI /AAMI EC12-2000-(R)2015IEC 62133:2017BS EN 10993FCC CFR 47: Part 15 Subpart C & Part 18ANSI-IEC-60529Medical Electrical EquipmentPart 1: General requirements for basic safety and essential performanceMedical Electrical EquipmentPart 12: General Requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – requirements and testsMedical Devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 20071001)Disposable ECG electrodesSecondary 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 applicationsBiological evaluation of medical devicesFCC CFR 47 Part 15 Subpart C covering the FCC requirements for Intentional Radiators, Part 18 Medical DevicesSpeciication for degrees of protection provided by enclosures (IP code)Intended UseThe 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, UKTel: +44 115 949 6960E-mail: novii.info@ge.comwww.monicahealthcare.comAbout Monica HealthcareWith 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.0843Part No: 107TF100USrev7© 2016 Monica Healthcare Ltd All rights reservedMonica 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

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