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

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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 flows seamlessly to your existing surveillance and archival system. Enhanced monitoring for difficult to monitor patients The Monica Novii monitors fetal heart rate, maternal heart rate and uterine activity, all with a single patch. It is an effective solution for monitoring high BMI patients (Ref 1, 2) and “We found Monica minimizes the risk of maternal/ fetal heart rate confusion (Ref 3, 4). In addition, the Patch to perform excellently requires no repositioning (Ref 4, 8) and the cable-free system in very obese women (35>BMI<60)” keeps the work environment clear and safe allowing for easier monitoring during some clinical procedures. Prof W Cohen, University of Arizona College of Medicine, Tucson USA 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).

Your Fetal Monitor The Novii System connects seamlessly with your monitor1. The Novii Pod, a small signal-processing and transmission device, connects effortlessly 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. Expanding maternal/fetal monitoring 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 effected 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). 1 Contact Monica Healthcare or their authorized representative for a full list

Accuracy Mobility and Freedom Monica Novii uses the abdominal fECG With no cables, belts or transducers and mECG wave shape to uniquely and no re-positioning, the Novii System identify and separate the maternal and allows real freedom and mobility which fetal heart rates. The fetal QRS complex can help the birthing process (Ref 6). The has a width less than 50% of the maternal system’s line of sight range of 30m (90 QRS. This and other differences between feet) allows the patient to move about the maternal and fetal ECG allow the the room freely. Monica Novii to be reasonably certain that the true FHR has been detected With no transducer leads between the (Ref 3, Ref 4). You can be confident that patient and the fetal monitor, the working you are monitoring the fetal heart even environment around the bed is kept clear in the most challenging circumstances and safe. The patient is free to get up shown below. In addition, the uterine without asking for assistance. EMG is used to extract the UA trace and has been shown in a clinical study to be equivalent to TOCO UA (Ref 5). 210 180 150 120 90 60 18:50 Scalp FHR Risk Mitigation Monica FHR SpO2 MHR In a high BMI patient, finding the ideal Monica UA transducer placement can be difficult. IUPC UA Because the Novii uses electrical signals, it is not impacted by maternal weight. This is data from the multi-centre clinical trial (Ref 1) showing the This translates into more reliable tracings Waterproof FSE FHR, IUPC UA and SpO2 (Ref 1, Ref 2). In addition, the Novii’s ability to MHR traces used to manage The Monica Novii Patch and Pod, simultaneously monitor and differentiate the patient. Superimposed are between the fetal and maternal heart rate when connected, are rated for total the simultaneously monitored water immersion to 1 meter, so they can Monica UA and FHR. The Monica can significantly reduce the likelihood of be left in place during a bath or shower. UA and FHR trace was not seen maternal/fetal confusion. by the Doctors and Nurses managing the patient. Monitoring continuity cannot be guaranteed when the Novii Pod is totally immersed in water.

Patient Friendly Workflow and Convenient Improvements The Monica Novii is a comfortable The Novii’s simple, ‘peel and stick’ design alternative to transducers with belts, eliminates the need to re-position which can cause irritation for some transducers. The single-patient-use patch patients. The patch only needs to be minimizes the risk of cross-contamination placed once, which means that the caused by inadequate cleaning. In patient does not need to be disturbed addition, the system’s ‘intelligent’ for repositioning, and since it is cordless, automated set-up provides help and the patient has greater flexibility in support messages to optimize and the room. simplify operation. To prevent Pods from being lost in operation, they are Studies have shown (Ref 7, non-white and the Interface will alert 8) that patient satisfaction the user if a Pod is not returned to a is likely to be higher when charging bay after use. monitored on the Novii compared to traditional transducers. It is light, small and causes minimal discomfort. 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 offer continuity of monitoring over extended periods.

References About Monica Healthcare High BMI: Ref 1 – Cohen WR, Hayes-Gill B. Influence of maternal body mass index Monica Healthcare is developing a series of innovative wearable on accuracy and reliability of external fetal monitoring techniques. Acta Obstet Gynecol Scand. 2014 Jun ; 93 (6) : 590-5. devices that uses wireless technologies to facilitate globally Ref 2 – Graatsma EM, Miller J, Mulder EJ, Harman C, Baschat AA, Visser accessible obstetric services in the home and hospital. GH. Maternal body mass index does not affect performance of fetal electrocardiography. Am J Perinatol. 2010 Aug ; 27 (7) : 573-7. MHR/FHR Confusion: Monica Healthcare Ltd was formed in May 2005 and was the Ref 3 – Cohen WR, Ommani S, Hassan S, Mirza FG, Solomon M, Brown R, Schifrin BS, Himsworth JM, Hayes-Gill BR. Accuracy and reliability culmination of 15 years of research at the School of Electrical and of fetal heart rate monitoring using maternal abdominal surface Electronic Engineering and the School of Human Development electrodes. Acta Obstet Gynecol Scand. 2012 Nov ; 91 (11) : 1306-13. Ref 4 – Stampalija T, Signaroldi M, Mastroianni C, Rosti E, Signorelli at The University of Nottingham, UK. V, Casati D, Ferrazzi EM. Fetal and maternal heart rate confusion during intra-partum monitoring: comparison of trans-abdominal fetal electrocardiogram and Doppler telemetry. The patented technology is based on the acquisition of electro- J Matern Fetal Neonatal Med. 2012 Aug ; 25 (8) : 1517-20. physiological signals that can be passively detected by electrodes Monica UA Compares with IUPC: Ref 5 – Hayes-Gill B, Hassan S, Mirza FG, Ommani S, Himsworth J, positioned on the maternal abdomen. From these signals a Solomon M, Brown R, Schifrin BS, Wayne R. Cohen WR. Accuracy number of parameters, fetal heart rate, maternal heart rate, uterine and Reliability of Uterine Contraction Identification Using Abdominal Surface Electrodes. Clinical Medicine Insights: Women’s Health 2012 : 5 65–75. activity, maternal movements and parameters describing Fetal ECG Mobility and Impact on Stage 1 of Labour: morphology and RR intervals (for research only) can be extracted, Ref 6 – Lawrence A, Lewis L, Hofmeyr GJ, Dowswell T, Styles C. Maternal positions and mobility during first stage labour. in real time and over an extended period of time. Cochrane Database Syst Rev. 2009 Apr 15 ; (2) : CD003934. Patient Satisfaction: Monica Healthcare is working with business partners to distribute Ref 7 – Reinhard J, Hayes-Gill BR, Yi Q, Hatzmann H, Schiermeier S. Comparison of non-invasive fetal electrocardiogram to Doppler and deliver professional solutions meeting the needs of modern cardiotocogram during the 1st stage of labor. obstetric care, risk management and patient satisfaction. J Perinat Med. 2010 Mar ; 38 (2) : 179-85. Ref 8 – Rauf Z, O’Brien E, Stampalija T, Ilioniu FP, Lavender T, Alfirevic 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. 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 Monica Healthcare Inc. Unit 8, Interchange 25 Business Park, 3862 Brentview Place Bostocks Lane, Kennesaw Nottingham GA 30144 NG10 5QG UK USA Tel: +44 115 9496960 Tel: +1 877 320 5174 Monica and Novii are registered trademarks of E-mail: sales@monicahealthcare.com Monica Healthcare in USA, EU, China and Japan www.monicahealthcare.com


Document Created: 2016-05-23 16:30:12
Document Modified: 2016-05-23 16:30:12
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