Medical Electrical Equipment. General Requirements for Basic Safety and Essential Performance. Collateral Standard. Electromagnetic Disturbances. Requirements and Tests PDF Download
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Author: Publisher: ISBN: Category : Electromagnetic compatibility Languages : en Pages : 456
Book Description
This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems. This collateral standard applies to the basic safety and essential performance of ME equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by ME equipment and ME systems. Basic safety with regard to electromagnetic disturbances is applicable to all ME equipment and ME systems.
Author: David J. Reinkensmeyer Publisher: Springer ISBN: 331928603X Category : Medical Languages : en Pages : 647
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: CHETAN KATHALAY Publisher: CHETAN KATHALAY ISBN: Category : Technology & Engineering Languages : en Pages : 464
Book Description
This book gives a step-by-step approach to CE marking of electrical and electronic equipment including risk assessment. It covers, in detail, five important directives viz. low voltage directive (LVD), electromagnetic compatibility (EMC) directive, medical devices directive (MDD), radio equipment directive (RED) and the RoHS directive. It provides insights into product design and test methodologies especially EMC and product SAFETY so that the product meets the technical requirements of the applicable standards. It also seeks to clarify the many doubts and misconceptions about CE marking. The book begins with a chapter that introduces the reader to the nuances of the CE marking process, the conformity assessment modules and to compile supporting documents that illustrate the process. This is followed by the chapter on product safety which describes the principles of safety as found in the international IEC and European harmonized safety standards. It provides ways and means to improve product design so as to ensure reasonable compliance when a product is subject to safety evaluation by a test laboratory. Then, there are two chapters dedicated to EMC. One explains the EMC fundamentals, standards and the test methodology while the other deals with EMC design. The design chapter contains ways and means to incorporate EMC measures like line filters, shielding, grounding and cable routing at the design stage so that the product can comply with the EMC tests with a minimum of iterations. The design means discussed are very practical in nature and are given in such a way that the design engineer can immediately incorporate them without worrying too much about theory. All the directives now-a-days require a detailed risk assessment to be carried out in addition to testing as per standards. Thereafter the risk assessment needs to be documented so as to demonstrate how the risks have been reduced/eliminated. The book deals with the risk assessment in detail for all the directives under consideration. And last but not the least, the CE marking procedure is not complete unless the entire process is documented through the so-called technical file or technical documentation. The last chapter explains the compilation of technical documentation as required by the directives and the European surveillance authorities.
Author: Gennadi Saiko Publisher: CRC Press ISBN: 1000632180 Category : Medical Languages : en Pages : 274
Book Description
Many of us in science have this "Aha!" moment when the mental puzzle is put together and you get a clear picture of a product, which will change the world. Moreover, you have a clear understanding of how it can be a commercial success. So, you decide to start a new company, a startup, and have a clear path to success. However, soon you come face to face with reality, where things are much more complicated. Only a minute fraction of startups survives and becomes successful. This is particularly true in the complex world of medical devices. There are many good books on startups but this book is specifically about startups specializing in medical devices, which are very different from other ones. It is written by a MedDev entrepreneur for first-time MedTech entrepreneurs.
Author: World Health Organization Publisher: World Health Organization ISBN: 9241509880 Category : Medical Languages : en Pages : 68
Book Description
The purpose of this guidance document is for the appropriate selection procurement utilization and maintenance of oxygen concentrators. This document also focuses on recommendations for the appropriate use and maintenance of oxygen concentrators in an effort to increase the availability management and quality of oxygen concentrators and ultimately to improve health outcomes in LRS. This document is intended to serve as a resource for the planning and provision of local and national oxygen concentrator systems for use by administrators clinicians and technicians who are interested in improving access to oxygen therapy and reducing global mortality associated with hypoxaemia.
Author: Almir Badnjević Publisher: Springer ISBN: 9811066507 Category : Technology & Engineering Languages : en Pages : 289
Book Description
This book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the processes, procedures and need for integrating medical devices into the legal metrology framework, addresses their independent safety and performance verification, and highlights the associated savings for national healthcare systems, all with the ultimate goal of increasing the efficacy and reliability of patient diagnoses and treatment. The book primarily focuses on diagnostic and therapeutic medical devices, and reflects the latest international directives and regulations. Above all, the book demonstrates that integrating medical devices into the legal metrology system and establishing a fully operational national laboratory for the inspection of medical devices could significantly improve the reliability of medical devices in diagnosis and patient care, while also reducing costs for the healthcare system in the respective country.
Author: Francis Hegarty Publisher: CRC Press ISBN: 1315354500 Category : Business & Economics Languages : en Pages : 595
Book Description
Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and other care providers, as well as financial stakeholders. The authors propose a management model based on interlinked strategic and operational quality cycles which, when fully realized, delivers a comprehensive and transparent methodology for implementing a HTM programme throughout a healthcare organization. The approach proposes that HTM extends beyond managing the technology in isolation to include advancing patient care through supporting the application of the technology. The book shows how to cost effectively manage medical equipment through its full life cycle, from acquisition through operational use to disposal, and to advance care, adding value to the medical equipment assets for the benefit of patients and stakeholders. This book will be of interest to practicing clinical engineers and to students and lecturers, and includes self-directed learning questions and case studies. Clinicians, Chief Executive Officers, Directors of Finance and other hospital managers with responsibility for the governance of medical equipment will also find this book of interest and value. For more information about the book, please visit the website.
Author: Juris Klonovs Publisher: Springer ISBN: 3319270249 Category : Medical Languages : en Pages : 102
Book Description
This book summarizes various approaches for the automatic detection of health threats to older patients at home living alone. The text begins by briefly describing those who would most benefit from healthcare supervision. The book then summarizes possible scenarios for monitoring an older patient at home, deriving the common functional requirements for monitoring technology. Next, the work identifies the state of the art of technological monitoring approaches that are practically applicable to geriatric patients. A survey is presented on a range of such interdisciplinary fields as smart homes, telemonitoring, ambient intelligence, ambient assisted living, gerontechnology, and aging-in-place technology. The book discusses relevant experimental studies, highlighting the application of sensor fusion, signal processing and machine learning techniques. Finally, the text discusses future challenges, offering a number of suggestions for further research directions.
Author: British Standards Institute Staff
Author: British Standards Institute Staff
Author: British Standards Institute Staff
Author: 
Author: David J. Reinkensmeyer
Author: CHETAN KATHALAY
Author: Gennadi Saiko
Author: World Health Organization
Author: Almir Badnjević
Author: Francis Hegarty
Author: Juris Klonovs