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Author: Almir Badnjević
Publisher: Springer Nature
ISBN: 3031434447
Category : Technology & Engineering
Languages : en
Pages : 441
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Book Description
This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!
Author: Almir Badnjević
Publisher: Springer Nature
ISBN: 3031434447
Category : Technology & Engineering
Languages : en
Pages : 441
Get Book Here
Book Description
This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!
Author: Claudio Becchetti
Publisher: John Wiley & Sons
ISBN: 1118652460
Category : Science
Languages : en
Pages : 600
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Book Description
This book explains all of the stages involved in developingmedical devices; from concept to medical approval including systemengineering, bioinstrumentation design, signal processing,electronics, software and ICT with Cloud and e-Healthdevelopment. Medical Instrument Design and Development offers a comprehensivetheoretical background with extensive use of diagrams, graphics andtables (around 400 throughout the book). The book explains how thetheory is translated into industrial medical products using amarket-sold Electrocardiograph disclosed in its design by the GammaCardio Soft manufacturer. The sequence of the chapters reflects the product developmentlifecycle. Each chapter is focused on a specific University courseand is divided into two sections: theory and implementation. Thetheory sections explain the main concepts and principles whichremain valid across technological evolutions of medicalinstrumentation. The Implementation sections show how the theory istranslated into a medical product. The Electrocardiograph(ECG or EKG) is used as an example as it is a suitable device toexplore to fully understand medical instrumentation since it issufficiently simple but encompasses all the main areas involved indeveloping medical electronic equipment. Key Features: Introduces a system-level approach to product design Covers topics such as bioinstrumentation, signal processing,information theory, electronics, software, firmware, telemedicine,e-Health and medical device certification Explains how to use theory to implement a market product (usingECG as an example) Examines the design and applications of main medicalinstruments Details the additional know-how required for productimplementation: business context, system design, projectmanagement, intellectual property rights, product life cycle,etc. Includes an accompanying website with the design of thecertified ECG product (ahref="http://www.gammacardiosoft.it/book"www.gammacardiosoft.it/book/a) Discloses the details of a marketed ECG Product (from GammaCardio Soft) compliant with the ANSI standard AAMI EC 11under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses(upper-level undergraduate and graduate students) and for engineersinterested in medical instrumentation/device design with acomprehensive and interdisciplinary system perspective.
Author: Carlo Boccato
Publisher: Springer Nature
ISBN: 3030856534
Category : Technology & Engineering
Languages : en
Pages : 284
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Book Description
This book provides caregivers and administrators with high-quality support for strategic decision making in the selection and use of medical devices so as to ensure value optimization. Medical treatment is increasingly complex, with wide application of medical devices and corresponding involvement of physics and engineering. A multidisciplinary methodology that brings together expertise from key disciplines in a holistic, system-oriented approach is essential in controlling this complexity and further improving health care. This book will help readers to understand the design, validation, and application of medical devices and the standards and regulations that apply to them across the world. In addition, it provides technical, operational, and economic perspectives on their use. The relevance of concepts such as expenditure optimization and sustainability to medical device technology is explained and healthcare reimbursement systems are discussed from different points of view. Readers will gain a clear appreciation of the managerial and economic implications of the use of medical devices and how to get the most out of them. Academic research, industrial experiences, and case studies are presented as appropriate.
Author: Richard Millis
Publisher: BoD – Books on Demand
ISBN: 9533079231
Category : Medical
Languages : en
Pages : 406
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Book Description
Electrocardiograms are one of the most widely used methods for evaluating the structure-function relationships of the heart in health and disease. This book is the first of two volumes which reviews recent advancements in electrocardiography. This volume lays the groundwork for understanding the technical aspects of these advancements. The five sections of this volume, Cardiac Anatomy, ECG Technique, ECG Features, Heart Rate Variability and ECG Data Management, provide comprehensive reviews of advancements in the technical and analytical methods for interpreting and evaluating electrocardiograms. This volume is complemented with anatomical diagrams, electrocardiogram recordings, flow diagrams and algorithms which demonstrate the most modern principles of electrocardiography. The chapters which form this volume describe how the technical impediments inherent to instrument-patient interfacing, recording and interpreting variations in electrocardiogram time intervals and morphologies, as well as electrocardiogram data sharing have been effectively overcome. The advent of novel detection, filtering and testing devices are described. Foremost, among these devices are innovative algorithms for automating the evaluation of electrocardiograms.
Author: Rommel Garcia
Publisher: Xlibris Corporation
ISBN: 1524589209
Category : Medical
Languages : en
Pages : 403
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Book Description
This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals alike who are trying their hand in the medical device industry and to those who have not been out of their silo to help see how each of the systems relate to each as a whole. However, it should be noted that the contents of this book should be taken only as information and is not intended to demonstrate how companies can be in compliance. In some instances, there are multiple ways to go through the maze of regulations that are documented and made by agencies because the regulations are pretty much made and designed to be flexible and high level so that companies can adopt their systems, which are solely designed for their purposes. Therefore, this book will try to avoid complicated words and complex technical details of engineering and statistics. This book will strive to be an embodiment of the honest-to-goodness, everyday experiences and issues that folks experience while working in the medical device industry.
Author: David J. Reinkensmeyer
Publisher: Springer
ISBN: 331928603X
Category : Medical
Languages : en
Pages : 647
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Book Description
This revised, updated second edition provides an accessible, practical overview of major areas of technical development and clinical application in the field of neurorehabilitation movement therapy. The initial section provides a rationale for technology application in movement therapy by summarizing recent findings in neuroplasticity and motor learning. The following section then explains the state of the art in human-machine interaction requirements for clinical rehabilitation practice. Subsequent sections describe the ongoing revolution in robotic therapy for upper extremity movement and for walking, and then describe other emerging technologies including electrical stimulation, virtual reality, wearable sensors, and brain-computer interfaces. The promises and limitations of these technologies in neurorehabilitation are discussed. Throughout the book the chapters provide detailed practical information on state-of-the-art clinical applications of these devices following stroke, spinal cord injury, and other neurologic disorders. The text is illustrated throughout with photographs and schematic diagrams which serve to clarify the information for the reader. Neurorehabilitation Technology, Second Edition is a valuable resource for neurologists, biomedical engineers, roboticists, rehabilitation specialists, physiotherapists, occupational therapists and those training in these fields.
Author: Xilin Liu
Publisher: Springer
ISBN: 3319679406
Category : Technology & Engineering
Languages : en
Pages : 268
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Book Description
This book provides an introduction to the emerging area of “Brain-Machine Interfaces,” with emphasis on the operation and practical design aspects. The book will help both electrical & bioengineers as well as neuroscience investigators to learn about the next generation brain-machine interfaces. The comprehensive review and design analysis will be very helpful for researchers who are new to this area or interested in the study of the brain. The in-depth discussion of practical design issues especially in animal experiments will also be valuable for experienced researchers.
Author: José Folgueras Méndez
Publisher: Springer Science & Business Media
ISBN: 3642211984
Category : Technology & Engineering
Languages : en
Pages : 1363
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Book Description
This volume presents the proceedings of the CLAIB 2011, held in the Palacio de las Convenciones in Havana, Cuba, from 16 to 21 May 2011. The conferences of the American Congress of Biomedical Engineering are sponsored by the International Federation for Medical and Biological Engineering (IFMBE), Society for Engineering in Biology and Medicine (EMBS) and the Pan American Health Organization (PAHO), among other organizations and international agencies and bringing together scientists, academics and biomedical engineers in Latin America and other continents in an environment conducive to exchange and professional growth.
Author: Joao Paulo do Vale Madeiro
Publisher: Academic Press
ISBN: 0128140364
Category : Technology & Engineering
Languages : en
Pages : 212
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Book Description
Developments and Applications for ECG Signal Processing: Modeling, Segmentation, and Pattern Recognition covers reliable techniques for ECG signal processing and their potential to significantly increase the applicability of ECG use in diagnosis. This book details a wide range of challenges in the processes of acquisition, preprocessing, segmentation, mathematical modelling and pattern recognition in ECG signals, presenting practical and robust solutions based on digital signal processing techniques. Users will find this to be a comprehensive resource that contributes to research on the automatic analysis of ECG signals and extends resources relating to rapid and accurate diagnoses, particularly for long-term signals. Chapters cover classical and modern features surrounding f ECG signals, ECG signal acquisition systems, techniques for noise suppression for ECG signal processing, a delineation of the QRS complex, mathematical modelling of T- and P-waves, and the automatic classification of heartbeats. - Gives comprehensive coverage of ECG signal processing - Presents development and parametrization techniques for ECG signal acquisition systems - Analyzes and compares distortions caused by different digital filtering techniques for noise suppression applied over the ECG signal - Describes how to identify if a digitized ECG signal presents irreversible distortion through analysis of its frequency components prior to, and after, filtering - Considers how to enhance QRS complexes and differentiate these from artefacts, noise, and other characteristic waves under different scenarios
Author: Emma Svennberg
Publisher: Frontiers Media SA
ISBN: 2832546129
Category : Medical
Languages : en
Pages : 103
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Book Description
This Research Topic is the second volume of the “Wearable Devices for Cardiac Rhythm Monitoring: Vol II”. Please see the first volume here.New wearable technologies for cardiac rhythm monitoring are gaining more and more importance in clinical routine in the field of cardiology and electrophysiology - by physicians as well as patients. These include, but are by far not restricted to smartphone-based ECG or PPG, finger-ECG, smartwatches, smart garments and more. This opens new horizons for mHealth-based patient care, mHealth-enhanced teleconsultations, but also mass screening for heart rhythm disorders.The proposed Research Topic aims to present new research on these technologies covering methodological aspects on wearable single- and multiple-lead ECG or photophlethysmography devices, (mass) screening for atrial fibrillation or other arrhythmias with new devices, implementation of mHealth into clinical pathways of cardiac diseases, short or long-term telemonitoring through wearables devices, cost-effectiveness, and more.
