Clinical engineering a handbook for clinical and biomedical engineers

CLINICAL ENGINEERING CLINICAL ENGINEERING A Handbook for Clinical and Biomedical Engineers AZZAM TAKTAK PAUL GANNEY DAVE LONG PAUL WHITE AMSTERDAM • BOSTON • HEIDELBERG • LONDON NEW YORK • OXFORD • PARIS • SAN DIEGO SAN FRANCISCO • SINGAPORE • SYDNEY • TOKYO Academic Press is an imprint of Elsevier Academic Press is an imprint of Elsevier The Boulevard, Langford Lane, Kidlington, Oxford, OX5 1GB, UK 225 Wyman Street, Waltham, MA 02451, USA 525 B Street, Suite 1800, San Diego, CA 92101-4495, USA First edition 2014 Copyright r 2014 Elsevier Ltd All rights reserved No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, mechanical, photocopying, recording or otherwise without the prior written permission of the publisher Permissions may be sought directly from Elsevier’s Science & Technology Rights Department in Oxford, UK: phone (144) (0) 1865 843830; fax (144) (0) 1865 853333; email: permissions@elsevier.com Alternatively you can submit your request online by visiting the Elsevier web site at http://elsevier.com/locate/permissions, and selecting Obtaining permission to use Elsevier material Notice No responsibility is assumed by the publisher for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress ISBN: 978-0-12-396961-3 For information on all Academic Press publications visit our website at elsevierdirect.com Printed and bound in the United Kingdom 14 15 16 17 18 10 Dedication In loving memory of my father Fouad You will always be in our hearts Azzam Acknowledgements Haar, Margaret Hannan, Rick Houghton, Henry Lumley, Linda Marks, David Mitchell, Wendy Murphy, Roy Nelham, Pauline Pope, David Porter, Pat Postill, Paul Richardson, Nigel Shapcott, Phil Swann, Linda Walker and Jon Ward Paul White would like to thank Tracey for her love, patience, encouragement and support for all the time associated with advancing Clinical Engineering and to our son Harry who makes it all worthwhile He would also like to thank those that have inspired and mentored him throughout his career and the department of Medical Physics and Clinical Engineering at Cambridge University Hospitals Foundation Trust and to the Postgraduate Institute at Anglia Ruskin University who allow him to push forward boundaries in clinical research on an international stage Azzam Taktak would like to thank his wife Diane and his children Chris and Sarah for their continued love and support He would also like to thank the following people who have had a major influence in shaping his career: Peter Rolfe, Paul Record, Iain Chambers, Alicia ElHaj, Justin McCarthy, Malcolm Brown, Tony Fisher, Steve Lake, Antonio Eleuteri, Paulo Lisboa and Bertil Damato Paul Ganney would like to thank his wife, Rachel, for her continued encouragement and his colleagues for many helpful discussions: especially Paul Ostro, Patrick Maw, Khalil Itani, Justin McCarthy and Bill Webster David Long would like to thank his wife, Fran, for her patience and encouragement, and to acknowledge the following people with whom he has had the privilege to work and who, in different ways, have influenced his thinking: Dave Calder, Paul Dryer, Barend ter xi Preface This book is aimed at professionals, students, researchers, or anyone who is interested in clinical engineering It provides a broad reference to the core elements of the subject for the reader to gain knowledge on how to successfully deploy medical technologies The book is written and reviewed by professionals who have been working in the field of clinical engineering for decades Many of the authors are clinical and biomedical engineers working in healthcare and academia and have also acted as trainers and as examiners on the subject As well as possessing engineering skills, clinical engineers must be able to work with patients and a range of professional staff They need to keep up to date with fast-moving scientific and medical research in the field, and to develop their own laboratory, design, analytical, management, and leadership skills This book is designed to assist the clinical engineer in this process The book is organized into four main sections The first section covers generic aspects of the core skills needed to work in this area It gives the reader a flavor of how to engage with research and development, data analysis and study design, and management and leadership It also discusses in detail the important role engineers play in the healthcare environment The second section covers legislation relevant to information technology based medical devices and standards concerned with security, encryption, and data exchange There is also material on software development/management and web development, which will be of interest to those working with these technologies across the entire field of clinical science and medical engineering The third section deals with clinical measurements and instrumentation It starts with a quick overview of medical electronics theory before moving on to clinical measurements It explains in detail the physics and engineering aspects involved in making useful and reliable measurements in the clinical situation Examples of clinical measurements covered include cardiology, hematology, neurophysiology, and respiratory The forth section provides a comprehensive summary of the subject of rehabilitation engineering and assistive technologies Topics covered include gait analysis, posture management, wheelchair and seating, and assistive technology It is the first comprehensive and practical guide for engineers working in a clinical environment I would like to express my sincere gratitude to my coeditors who spent a considerable amount of time and energy recruiting authors and pulling together the material for their own sections, while working in such a demanding environment I would also like to thank the authors and the reviewers for the fantastic effort they have put in I hope you enjoy reading this book and find it illuminating xiii Foreword the book seem very complete The web and computer sections give the book a very up-todate feel Professor Azzam Taktak has edited the book and chosen with care some excellent coeditors and authors to contribute His concept of the book came out of his vast experience in teaching the subject at his hospital and university, both in the classroom and using electronic learning He has contributed to the new Modernising Scientific Careers (MSC) NHS programme and this experience has enhanced the book It is interesting that the MSC course also includes leadership and professional issues as a key component, and it reassuring that this is included in this complete course on clinical engineering The contents of the book follow a logical sequence, that take the reader from a brief look at the anatomy and physiology of humans, to statistics, good clinical practice, the role of clinical engineers in hospitals, and information and computer systems These subjects make up the first two sections of the book, which are about presenting the background ‘core’ areas and the legal processes involved The final two sections of the book cover all the main areas of clinical measurement and rehabilitation I have had the pleasure of knowing Azzam for many years It is hard to think of anyone with more knowledge and experience of Clinical Engineering is a broad arena and practitioners in this area need to understand a wide range of subjects, some in great detail, and others with just a working knowledge In my experience although there are many separate books covering the complete subject area, there is no complete book that professes to cover the entire range of subjects, which can be a useful reference for the professional working in this field Clinical engineers must have a working knowledge of the human body, both in how it functions and its anatomy They must be able to work with patients, clinical staff and other health professionals They need to be experts in their engineering areas, but keep up to date in the relevant research and innovations in this field Finally they must be able to lead and manage, both themselves and their teams This book seems unique in that the wide range of subjects mentioned is included, some in great detail, others necessary less so, but most chapters are referenced widely, with useful extra reading material presented for further study There are some innovative parts of the book For example, a section on leadership is not often included in text books such as this, but this particular chapter is very well presented, in a very personal style, with thought provoking exercises and sections The excellent chapters making up the section on rehabilitation engineering are unusual to be included in a book such as this, but they make xv xvi FOREWORD clinical engineering in its widest form, and he has an extensive network of colleagues he can draw upon to contribute to this work I have also had the pleasure of knowing most of the excellent authors in the book Some chapters have been written by single authors, others by multiple ones The variety in authorship gives a refreshing combination of styles, which keeps the writing alive and accessible The book will be a valuable resource for many engineers and clinicians working in this area, and also to refresh the many experts involved in the field of clinical engineering Professor Mark Tooley PhD FIET FIPEM FinstP FRCP Consultant Clinical Scientist, Royal United Hospital, Bath List of Contributors Bath Institute of Medical Engineering Tim Adlam John Amoore Department of Medical Physics, NHS Ayrshire and Arran, Scotland, U.K Richard G Axell Clinical Scientist, Medical Physics and Clinical Engineering, Cambridge University Hospitals NHS Foundation Trust, Cambridge, U.K and Honorary Visiting Research Fellow, Postgraduate Medical Institute, Anglia Ruskin University, Chelmsford, U.K Dan Bader University of Southampton Paul Blackett Lancashire Teaching Hospitals NHS Foundation Trust, Lancashire, U.K Tom Collins Queen Mary’s Hospital Chailey Heritage Clinical Services Donna Cowan David Ewins of Surrey Queen Mary’s Hospital and University Paul S Ganney University College Hospitals NHS Trust, London, U.K Vicky Gardiner London University of Bath Tim Holsgrove University of Bath Paul Horwood Trust Oxford University Hospitals NHS Robert Lievesley Kent Communication Assistive Technology Service (Kent CAT) University of Exeter Chris Morris Ladan Najafi East Kent Adult Communication and Assistive Technology (ACAT) Service Fiona Panthi East Kent Adult Communication and Assistive Technology (ACAT) Service Sandhya Pisharody and Jodie Rogers East Kent Adult Communication and Assistive Technology (ACAT) Service Anthony Scott Brown Royal Cornwall Hospitals NHS Trust, Truro, U.K Richard Scott Sherwood Forest Hospitals NHS Foundation Trust, Nottinghamshire, U.K Ian Swain Oxford University Hospitals NHS Tori Mayhew Trust Oxford University Hospitals NHS Oxford University Hospitals NHS Salisbury NHS Foundation Trust Azzam Taktak Royal Liverpool Hospital, Liverpool, U.K University Elizabeth M Tunnicliffe University of Oxford Centre for Clinical Magnetic Resonance Research, John Radcliffe Hospital, Oxford, U.K Will Wade ACE Centre North Merlin Walberg David Long Trust Varian Medical Systems, U.K Nicholas P Rhodes Department of Musculoskeletal Biology, Institute of Ageing and Chronic Diseases, University of Liverpool, Liverpool, U.K Martin Smith Trust Opcare Fran J Hegarty Medical Physics & Bioengineering Department, St James’s Hospital, Dublin, Ireland Mike Hillman Ed McDonagh Diagnostic Radiology/PACS Royal Marsden Hospital NHS Trust, London, U.K Phoenix Consultancy USA, Inc Paul A White Cambridge University Hospitals NHS Foundation Trust, Cambridge, U.K and Anglia Ruskin University, Chelmsford, U.K Duncan Wood Justin P McCarthy Clin Eng Consulting Ltd, Cardiff, U.K xvii Salisbury NHS Foundation Trust P A R T I GENERAL Azzam Taktak, Anthony Scott Brown, Merlin Walberg, Justin P McCarthy, Richard Scott, Paul Blackett, John Amoore, and Fran J Hegarty Anatomy and physiology Research methodology 21 Good clinical practice 33 Health technology management 43 Leadership 59 Risk management 75 The role of clinical engineers in hospitals 93 Overview Over the past century, healthcare has become increasingly reliant on medical technology Engineers play a pivotal role in the deployment and use of technology To this successfully they require solid knowledge of underpinning sciences and skills such as mathematics, physics, design, fabrication, and so on In addition, clinical engineers require knowledge of some generic aspects related specifically to healthcare This section gives an overview of such aspects with chapters on anatomy and physiology, research methodology, Good Clinical Practice, risk management, and healthcare technology management More recently, there has been much emphasis on developing leadership skills of engineers working in the healthcare environment and this section includes a chapter on leadership, quoting many examples on how it can be a powerful tool in the workplace The final chapter in this section brings all these topics together to highlight the important role clinical engineers play in applying their skills and knowledge in healthcare provision through appropriate deployment of the technology whilst containing cost and increasing access 428 26 MECHANICAL AND ELECTROMECHANICAL DEVICES As any change is likely to unbalance the MAS, a similar assessment and setting up process must be followed ROBOTICS Definitions A robot is traditionally described (by the Robot Institute of America in 1979) as “a re-programmable, multifunctional manipulator designed to move material, parts, tools or specialized devices through variable programmed motions for the performance of a variety of tasks.” This definition is still relevant for a traditional industrial application However, the application of robotics in a nonindustrial application, such as healthcare or rehabilitation, requires a more advanced definition “The integration of enabling technologies and attributes embracing manipulators, mobility, sensors, computing (IKBS, AI) and hierarchical control to result ultimately in a robot capable of autonomously complementing man’s endeavors in unstructured and hostile environments” (described by the U.K Department of Trade and Industry’s Advanced Robotics Initiative in 1987; Hillman, 2004) From these definitions we see that a robot is not limited to either the humanoid representation of science fiction or the traditional industrial definition Within rehabilitation, robotics have been applied in the following areas Assistive Robotics Assistive robotics aims to help those with often severe levels of disability to live as independently as possible in a relatively unmodified environment Examples of applications are: • Fixed site: The disabled user is able to use the robot (often a variation on a small industrial robot arm) in a workstation environment set up to optimize specific tasks These may be of an “office” type or more personal areas such as eating or personal hygiene (Van der Loos, 1995; Hammel et al., 1989) Although many research groups have developed such systems, which have been used effectively, and a small number of commercial products have been available, the limitations are obvious Though no commercial products are currently available, one of the most costeffective systems was the Handy (Topping, 2001) • Mobile: For some, the ideal has been to provide a robotic carer The most notable implementation of this was the Movar system developed at Stanford University (Van der Loos et al., 1986) More recently, this concept has been extended to the care of the elderly but with the emphasis on communications rather than manipulation • Wheelchair mounted: For wheelchair users having compromised upper-limb mobility and dexterity, the ideal might be a “third arm” mounted to the wheelchair The MANUS (Kwee et al., 1989) iArm by Exact Dynamics6 is the most successful product in this area and still continues in production Though popular in its home country of the Netherlands, costs can be prohibitive The two main obstacles to a wider use of wheelchair robotics (besides price) are of an efficient human machine interface and the problems of integrating the system to a wheelchair without compromising overall width, stability, and battery life of the wheelchair Two examples of wheelchair mounted robot arms are shown in Figures 26.19 and 26.20 www.exactdynamics.nl IV REHABILITATION ENGINEERING AND ASSISTIVE TECHNOLOGY ROBOTICS 429 FIGURE 26.19 Robot arm in use to provide increased reach Source: Assistive Innovations Therapy At the time of writing, the greatest interest in robotics in rehabilitation both in terms of research and commercial products is in providing therapy to the hand, upper limb, and lower limb Much of this has concentrated on the rehabilitation of stroke survivors Effective stroke rehabilitation therapy makes use of the ability of the human brain to rewire itself (neuroplasticity) following damage to a part of the brain It has been found that intensive repetition of movement promotes motor recovery following a stroke (Dipietro et al., 2012) Therapy can be given in the following ways (Lum et al., 2002): • Passive: Movement is externally imposed by the robot while the patient remains relaxed • Active: Patient initiates the movement, but the robot assists along a predefined path • Active resisted: Patient must move against a resistance generated by the robot FIGURE 26.20 Enabling access to the work environment Source: Assistive Innovations As the potential of robot-mediated therapy is explored, the research questions that are being addressed are: Is it an effective therapy? Is it IV REHABILITATION ENGINEERING AND ASSISTIVE TECHNOLOGY 430 26 MECHANICAL AND ELECTROMECHANICAL DEVICES more effective than current exercise therapies by physiotherapists? Is it cost effective? Apart from physical rehabilitation it should be noted that robotics are also being used for cognitive therapy of children with autism (Robins et al., 2004) Exoskeletons At a completely different level of technical complexity are exoskeletons which are now starting to appear on the market These are robotic devices requiring actuators, sensors, and power packs Much of the initial research was pushed by potential for military application to assist soldiers in carrying heavy loads over rough ground However, the application to people with disabilities was recognized early, the challenges being to decrease the weight needing to be carried and finding a way to provide integration with the patient (Zoss et al., 2006; Suzuki et al., 2007) Other Application Areas Robotics have also been applied in the areas of smart wheelchairs with long range and short range navigational functions, and smart prosthetics, notably of the knee and the hand Other areas of potential application are in education and communication References Adams, M., Bogduk, N., Burton, K., Dolan, P., 2006 The Biomechanics of Back Pain Elsevier Ltd., Philadelphia Bozic, K.J., Ries, M.D., 2005 Wear and osteolysis in total hip arthroplasty Semin Arthroplasty 16 (2), 142À152 Cassinelli, E.H., Kang, J.D., 2000 Current understanding of lumbar disc degeneration Oper Tech Orthop 10 (4), 254À262 Dipietro, L., Krebs, H.I., Volpe, B.T., Stein, J., Bever, C., Mernoff, S.T., et al., 2012 Learning, not adaptation, characterizes stroke motor recovery: evidence from kinematic changes induced by robot -assisted therapy in trained and untrained task in the same workspace IEEE Trans Neural Syst Rehabil Eng 20 (1), 48À57 Goel, V.K., Panjabi, M.M., Patwardhan, A.G., Dooris, A.P., Serhan, H., 2006 Test protocols for evaluation of spinal implants J Bone Joint Surg Am 88 (Suppl 2), 103À109 Gortchacow, M., Wettstein, M., Pioletti, D.P., Muăller-Gerbl, M., Terrier, A., 2012 Simultaneous and multisite measure of micromotion, subsidence and gap to evaluate femoral stem stability J Biomech 45 (7), 1232À1238 Hammel, J., Hall, K., Lees, D., Leifer, L., Van der Loos, M., Perkash, I., et al., 1989 Clinical evaluation of a desktop robotic assistant J Rehabil Res Dev 26 (3), 1À16 Hillman, M., 2004 Rehabilitation Robotics from Past to Present À A historical perspective In: Bien, Z.Z., Stefanov, D (Eds.), Advances in Rehabilitation Robotics Springer, pp 25À44 International Organization for Standardization (ISO), 1989 ISO 8549-1 Prosthetics and Orthotics - Vocabulary, Part 1: General Terms for External Limb Prostheses and External Orthoses ISO, Geneva International Organization for Standardization (ISO), 1989 ISO 8549-1 Prosthetics and Orthotics - Vocabulary, Part 3: Terms Relating to External Orthoses ISO, Geneva Jasty, M., Bragdon, C., Burke, D., O’Connor, D., Lowenstein, J., Harris, W.H., 1997 In vivo skeletal responses to porous-surfaced implants subjected to small induced motions J Bone Joint Surg Am 79 (5), 707À714 Kienapfel, H., Sprey, C., Wilke, A., Griss, P., 1999 Implant fixation by bone ingrowth J Arthroplasty 14 (3), 355À368 Kurtz, S.M., Muratoglu, O.K., Evans, M., Edidin, A.A., 1999 Advances in the processing, sterilization, and crosslinking of ultra-high molecular weight polyethylene for total joint arthroplasty Biomaterials 20 (18), 1659À1688 Kwee, H., Duimel, J., Smits, J., Tuinhof de Moed, A., van Woerden, J., 1989 The MANUS Wheelchair-Borne Manipulator: System Review and First Results Proc IARP Workshop on Domestic and Medical and Healthcare Robotics, Newcastle Lum, P., Reinkensmeyer, D., Mahoney, R., Rymer, W.Z., Burgar, C., 2002 Robotic devices for movement therapy after stroke: Current status and challenges to clinical acceptance Top Stroke Rehabil (4), 40À53, 2002 Morrey, B.F., 2003 Joint Replacement Arthroplasty Churchill-Livingstone, Philadelphia National Joint Registry, 2011 National Joint Registry for England and Wales 8th Annual Report 2011 Hemel Hempstead, U.K., The NJR Centre Nordin, M., Frankel, V.H., 2001 Basic Biomechanics of the Musckuloskeletal System Lippincott, Williams & Wilkins, Philadelphia Ratner, B.D., Hoffman, A.S., Schoen, F.J., Lemons, J.E., 1996 Biomaterials Science: An Introduction to Materials in Medicine Academic Press, San Diego Ries, M.D., 2011 Highly crosslinked ultrahigh molecular weight polyethylene in total hip arthroplasty: no IV REHABILITATION ENGINEERING AND ASSISTIVE TECHNOLOGY 431 ROBOTICS further concerns-opposes Semin Arthroplasty 22 (2), 82À84 Robins, B., Dautenhahn, K., Boekhorst, R., Billard, A., 2004 "Effects of repeated exposure to a humanoid robot on children with autism" Published In: Keates, S., Clarkson, J., Langdon, P., Robinson, P (Eds.), Designing a More Inclusive World Springer Verlag, London, pp 225À236 Rodriguez, J.A., 2006 Acetabular Fixation Options: Notes from the Other Side J Arthroplasty 21 (Suppl 4), 93À96 Solomon, L., 1992 Hip replacement: Prosthetic fixation Curr Orthop (3), 153À156 Suzuki, K., Mito, G., Kawamotot, H., Hasegawa, Y., Sankai, Y., 2007 Intention-based walking support for paraplegia patients with robot suit HAL Adv Robot 21 (12), 1441À1469 Swedish Hip Arthroplasty Register, 2011 Swedish Hip Arthroplasty Register Annual Report 2010 Gothenburg, Sweden, Swedish Hip Arthroplasty Register Swedish Knee Arthroplasty Register, 2011 Swedish Hip Arthroplasty Register Annual Report 2011 Lund, Sweden, Swedish Knee Arthroplasty Register Topping, M., 2001 Handy 1, A robotic aid to independence for severely disabled people In: Mokhtari, M (Ed.), Integration of Assistive Technology in the Information Age IOS, Netherlands, pp 142À147 Van der Loos, M., 1995 VA/Stanford Rehabilitation Robotics Research and Development Program: Lessons learned in the application of robotics technology to the field of rehabilitation IEEE Trans Rehabil Eng (1), 46À66 Van der Loos, M., Michalowski, S., Leifer, L., 1986 Design of an Omnidirectional Mobile Robot as a Manipulation Aid for the Severely Disabled Foulds R (Ed.), Interactive Robotic Aids World Rehabilitation Fund Monograph #37, New York Wang, M.L., Sharkey, P.F., Tuan, R.S., 2004 Particle bioreactivity and wear-mediated osteolysis J Arthroplasty 19 (8), 1028À1038 World Health Organization (WHO), 2001 International Classification of Functioning, Disability and Health ,www.who.int/classifications/icf/en/ (last accessed October 2012) Zivic, F., Babic, M., Grujovic, N., Mitrovic, S., Favaro, G., Caunii, M., 2012 Effect of vacuum-treatment on deformation properties of PMMA bone cement J Mech Behav Biomed Mater (1), 129À138 Zoss, A.B., Kazerooni, H., Chu, A., 2006 Biomechanical design of the berkeley lower extremity exoskeleton IEEE/ASME Trans Mechatronics 11 (2), 128À138 Zysset, P.K., Guo, X.E., Edward Hoffler, C., Moore, K.E., Goldstein, S.A., 1999 Elastic modulus and hardness of cortical and trabecular bone lamellae measured by nanoindentation in the human femur J Biomech 32 (10), 1005À1012 Further Reading Prosthetics Levine, D., Richards, J., Whittle, M.W., 2011 Whittle’s Gait Analysis fifth ed Butterworth-Heinemann Lusardi, M., Nielsen, C., 2012 Orthotics and Prosthetics in Rehabilitation third ed Elsevier Ratner, B.D., Hoffman, A.S., Schoen, F.J., Lemons, J.E., 2008 Biomaterials Science third ed Elsevier ă zkaya, N., Nordin, M., Goldsheyder, D., Leger, D.L., O 2012 Fundamentals of Biomechanics À Equilibrium, Motion and Deformation third ed Springer Smith, D.G., Michael, J.W., Bowker, J.H., 2004 Atlas of Amputations and Limb Deficiencies À Surgical, Prosthetic and Rehabilitation Principles American Academy of Orthopaedic Surgeons Tortora, G.J., Derrickson, B.H., 2011 thirteenth ed Wiley Orthotics Morris, Dias, (Eds.), 2007 Paediatric Orthotics Clinics in Developmental Medicine No 175 MacKeith Press Mosby, C.V., 1985 Atlas of Orthotics, Biomechanical Principles and Applications American Academy of Orthopaedic Surgeons, St Louis Rose, G.K., 1986 Orthotics - Principles & Practice William Heinemann, London Robotics Hillman, M., 2004 Rehabilitation robots from past to present - A historical perspective In: Bien, Z., Stefanov, D (Eds.), Advances in Rehabilitation Robotics Lecture Notes in Control and Information Sciences #306 Springer, New York Resources Aids for Daily Living As described in this chapter’s “Aids for Daily Living” section, there is a vast array of assistive technology available commercially A simple Internet search will yield plentiful results In the United Kingdom, the Disabled Living Foundation (www.dlf.org.uk) is a charity offering independent advice on these types of products and can be an extremely useful resource IV REHABILITATION ENGINEERING AND ASSISTIVE TECHNOLOGY Index Note: Page numbers followed by “f ” and “t ” refers to figures and tables respectively A Acquired brain injury (ABI), 378 AC signals’ complex Ohm’s law, 201À202 Adaptations, 338 Adenosine triphosphate (ATP), Advanced Encryption Standard (AES), 187À188 Airway resistance, 250f Ambient temperature and pressure saturated (ATPS), 251À252 Amino acid structure, 7f Amplifier differential operation, 204f, 206f instrumentation, 206f inverting, 203f noninverting, 203f Amputation levels, upper/lower limb, 413f Analysis of variance (ANOVA), 26 Anaphylotoxins, 17 Anesthetic workstations, 95 Aneurysm, 11 Ankle-foot orthoses (AFOs), 279, 419, 419f Annual healthcare technology management plan (AHTM Plan), 44 ANOVA (Analysis of variance), 26 Anterior superior iliac spines (ASISs), 291À292 Anti-CD28 monoclonal antibody TGN1412, 33 Antidiuretic hormone (ADH) mechanism, 17f Appetite, hormonal regulation of, 19f Apple’s iOS system, 134, 380 Arteries, 12f deliver blood, 11 in to heart, 220 venous system, 11 Artificial intelligence (AI), 163, 165 Artificial neural network (ANN), 166 AS/NZS 4360:2004 risk management policy, 82 ASP.NET-based server, 186 Assistive technology (AT), 361 Asymmetric tonic neck reflex (ATNR), 295, 360 Atherosclerosis, 11 Atrial fibrillation, 225 Atrial systole, 10 Atrioventricular (AV) node, 220À221, 225 Augmentative and alternative communication (AAC), 364, 369 Augmented limb leads, 226 Australian Standard AS/NZS 4360:2004, 90 B Baroreceptors, 16À17 Basic multicellular units (BMUs), bCapsLockOn, 136 Bessel filter, 237 Bicuspid valves, 220 Bipolar transistors, 201f Blinding, 23 Blood cell types, 14t coagulation system, 15À16 constituents, 14t deoxygenated, 219 overview of, 14À15 specific functions, 14t Blood pressures, 13f fluids flow, 229 hemodynamic monitoring, 231À234 intra-arterial, 230 measurement methods, 230À234 Blood vessels, 17 433 diameter, 13t injuries, 15t B-mode imaging, 222 Body configuration, 290À296 arms, position/movement, 295 feet, position of, 293 hips, alignment of, 292À293 lying position, 295À296 movement patterns, 295 neurological phenomena, 295 overview of, 290À296 pelvic orientation, 291 shoulder girdle, orientation, 293 spinal alignment, 293À295 weight bearing, 295 Body mass index (BMI), 311 Body temperature and pressure saturated (BTPS), 244À245, 249 Bone cement, 422À423 Bone ingrowth, 423 Bone physiology, 7À9 Bones human, 7f types, 8t Boyle’s law, 14, 248À249 Brain-computer interface (BCI), 373, 380À382 detecting intentions, 381 surface EEG, 381À382 device control, 382 future, 382 P300, 382 sensorimotor rhythms, 382 Brainstem auditory evoked potentials (BAEPs), 241 Brainstorming, 265À266 British Standards Institution (BSI), 46 BS ISO 31000:2009, 81À82 risk management policy, 81À82 Bugs, 151 Butterworth filter, 208f 434 C C11 code, 181f nonprocedural code, 145f Caesar, 187 Caldicott committee, 116À117 Cancellous bone, finite element model (FEM) of, 164f Capacitor, 195À198 film, 198 series and parallel, 197f Capillaries, 17 Cardiac cycles, 220À221 Cardiac index (CI), 232 Cardiac muscle cells, 10 Cardiac output, 232 Cardiac physiology, 10 Cardiac pressure, 231À232 Cardiology ambulatory monitoring, 227À228 anatomy/physiology, 219À221 echocardiography, 221À224 electrocardiography, 225À228 exercise stress testing, 228 Cardioregulatory center, 16 Cell membrane, structure of, 4f Cell physiology, 3À5 Cell replication, principles of, 5À7 Cementless fixation, 423 Ceramics, 422 Cerebrovascular accident (CVA), 426 CGI scripts, 180 Chartered society of physiotherapy (CSP), 400 Chebyshev filter, 208f, 210 Checksums, 120 Chemocenters, 17 Chest leads, 226 Clinical engineering department (CED), 45À46 Clinical engineers, 101, 102f keystone model, 103f Clinical gait analysis See Gait analysis Clinical investigation plan (CIP), 38À39 vs clinical trials, 37 medicinal products, 36À37 Clinical measurement accuracy/precision, 211À212 calibration, 214 device errors, 212À213 digital display, 213 INDEX electrocardiogram (ECG) machine, 213 hypothesis testing, 217t low/high accuracy, 212f low/high precision, 212f null hypothesis, 217 overview of, 211 pointer-scale-reader interaction, 212À213 sensitivity and specificity testing, 216t systematic error, 213 technique, sensitivity/specificity of, 215À217 traceability, 214 type I/II errors, 217 uncertainty, 214À215 Clinical Movement Analysis Society U.K and Ireland (CMAS), 400 role of, 400 Clinical research phases of, 33À34 standards of, 33À35 Clinical trials of investigational medicinal products (CTIMPs), 33, 37À38 Clinical trials regulations, 35f Clotting cascade, 15f Clotting system, 14 COACH system controller, 384 Coagulation cascade, 15 Coefficient of determination, 28À29 Collision detection, 124 Common gateway interface (CGI), 171 Common mode rejection (CMR), 204 Communication patient assessment, principles of, 258À262 Competent authority (CA), 39, 81 approval, 39 Complex communication needs (CCN), 364À365 Computer-aided design (CAD), 162 Computer numerical control (CNC), 414 Conductance catheter, 233 Confidence intervals, 27 Continuous wave (CW), 222 Contract research organization (CRO), 33, 38 Corneocytes, 309 Corrective maintenance, 51 Correlation, 28À30 Cross-enterprise document sharing (XDS), 129À130 Cryptography, 187 asymmetric key, 188 block and stream ciphers, 187À188 overview of, 187 public-key cryptography, 188À189 symmetric key, 188 CSMA channel, 124 CString, 144À145 Custom-contoured seating background, 339 case studies, 344À345 casting process, 344f contraindications, 345 head positioning, 344 materials used in, 339À342, 340t molded foam, 343f pelvis/leg positioning, guidelines, 342 platform seat to facilitate mobility, 345f scanned digital image, 342f section, 335 shape, taking, 342À344 Custom-made toilet seat, 410f D Dalton’s law, 14 Data conversion, 127f Data flow diagrams (DFD), 140 Data interpretation, 399À400 Data loss prevention (DLP), 120À121 Data Protection Act 1998 (DPA), 114 Data streaming, tagged format, 127f Deciphering, 187 Deep tissue injury (DTI), 310À311 Dental implants, 423À424 Deprivation of liberty safeguards (DOLS), 261 Device tracking, implementing technologies, 168t Dibbers, 376 DICOM file format, 127À128 Digital envelopes, 189 Digital signatures, 120, 188À189 Dinamap (device for indirect noninvasive mean arterial pressure), 230 Diodes, 199, 200f voltage relationship, 200f Directive 2007/47/EC, 110À111 INDEX Disability/smart house technology, 364, 383À385 actuators, 384 autonomy, 384À385 controllers, 383À384 ethics, 384À385 network systems, 384 sensors, 383 Disarticulation, 411 DNA centered leadership, 59 characteristics, 5À6 code for life, 5f genetic code, 6t replication, 7f Doppler measurement, 223À224 Doppler shift frequency, 222 Doppler ultrasound, 222 Double tapered hip replacement device, 423f Drop foot correction electrode positions, 280f gait cycle and stimulation phases, 279f Drug trials, competent authorities, 40t Dynamical systems theory, 397 E Echocardiography scanning, 221À224 transducer positioning/standard scanning views, 224f Effective regurgitant orifice area (EROA), 224 e-Government Interoperability Framework (e-GIF), 130 Einthoven’s triangle, 226f Ejection fraction (EF), 232 Electrical flow, 229 Electrically powered indoor (wheel) chairs (EPIC), 351 Electrocardiograph (ECG), 223À224 alpha waves, 240 beta waves, 240 delta waves, 239 electrical signal measurement, 235 PQRST ECG waveform, 225f rhythmic EEG bands, 240f techniques, 239 theta waves, 239 12-lead ECG, 227 definitions, 226t normal chest lead appearance, simulation of, 227f Electrocardiography, 225À228 Electrode positions, 239f Electroencephalography (EEG), 239 Electromedical device, 94 Electromyography (EMG), 397À398 use of, 237 Electronic assistive technology (EAT), 355À356, 359, 369À373, 409 alternative access components of, 369À370 keyboards, 371 overview of, 370À372 pointer control, 370À371 principles of, 369 switches, 371À372 appropriate device, selection, 361 assessment of, 359À361 environmental control systems See Environmental control systems future of access, 373 brain-computer interface (BCI), 373 eye gaze technology, 373 gesture recognition, 373 tongue drive system (TDS), 373 integrated systems, 373À375 factors to consider, 374À375 reasons for integration, 374 mainstream technology, 375À380 high-tech technology, future of, 376À380 need for, 375À376 posture management, 359À360 software/control enhancers, 372À373 accessibility options, 372 interface positioning, 372À373 onscreen keyboards, 372 screen magnifiers, 372 screen readers, 372 speech recognition software, 372 word prediction software, 372 Electronic tracking devices, 169 Elevating leg rests (ELRs), 333 Embedded system, 149À151 Emotional intelligence, 62À64 relationship management, 63À64 self-awareness, 62À63 self-motivation, 63 self-regulation/self-management, 63 social awareness, 63 social skills, 63À64 435 Emotiv EPOC neuroheadset, 381f Enciphering, 187 End-diastolic volume (EDV), 232 EndNote, 31 Endoplasmic reticulum (ER), End systolic pressure-volume relationship (ESPVR), 233À234, 234f Energy expenditure, 398À399 Energy storage, in body, 20f Engineers, titles for, 257 Enteric nervous system, 10 Entity-relationship diagram (ERD), 140, 157 Environmental control systems, 361À364 access, 362 areas of function, 362 assessment process, 363À364 augmentative/alternative communication, 364À369 access methods low tech, 365 high tech, 366À368 light/medium tech AAC systems, 365À366 low tech, 365 enabling access, 429f high tech VOCAs, 366À368 access method, 367À368 integration features, 368 physical features, 367 vocabulary packages, 367 iPad with Sensory Software’s Grid Player app, 368f large buttoned programmable infrared operated remote control, 364f primo infrared controller offering, 362f symbol based communication book, 366f vivo infrared controller, 363f voice output communication aid (VOCA), 363À364 Epidemiological research, 312 Epilepsy, 354 Equipment management, 46 Equipment support plan (ESP), 46, 54f Equivalent series resistance (ESR), 197 Erythrocytes, 14 Ethernet, 124 Ethylene vinyl acetate (EVA) foams, 417 436 E-tran frame, 365f Euler/Cardan angles, 403 European Pressure Ulcer Advisory Panel (EPUAP), 310 Exercise bike, 410f Eye gaze system, 371f Eye gaze technology, 371 F Failure mode and effects analysis (FMEA), 272À273 Fault tree analysis (FTA), 272À273 FDA regulations, 108 Fibrinolytic system, 14 Fick principle states, 232 Field safety corrective actions (FSCA), 86 Filter, 206À210 different forms, 208f surface electromyography (sEMG) signal, 209f time and frequency domain, 207f transfer function, 206À207 Finite element analysis (FEA), 162À163, 313 Firmware, 150 Fixed frame wheelchair, 332f Fleisch pneumotachometer, 246 Flexible scoliosis, correction, 302f Fluids flow in circulation, 13f pressure, overview of, 229 Folding frame wheelchair, 332f Food group net energy values of, 19f physiological uses of, 19f Food processing, 18f Foot, free body diagrams, 405f for, 137 Foreign keys, rules, 157 Freedom of Information Act 2000 (FOI), 115 Frequency domain, 206À207 signal within, 206 time, 207f Frequency response of AD8221 instrumentation amp, 206f model of, 195f Frontal pelvic angle, 291 Front-wheel drive (FWD), 352 Functional electrical stimulation (FES), 275, 419 INDEX application, stimulated movement control, 281À283 basic design of, 281f definition of, 276 desired outcome for patient, 279 overview of, 275À276 physiological principles of, 276À277 practical, designing, 277À279 representation, 281f tibialis anterior, real activity, 282f Functional foot orthoses, 418À419 Functional magnetic resonance imaging (fMRI), 381 Functional residual capacity (FRC), 247À248 G Gait analysis clinical applications of, 389 degrees of freedom (DOF), 403 gait cycle, phases of, 391t human locomotion, 389 key spatial parameters, definition, 392f kinematics/kinetics, 394À397, 402À403 normal gait, 390À392 observational gait analysis (OGA), 393À394 patient functional self-assessment questionnaires, 392 phases of, 391t tools/methods, 389 typical gait assessment procedure, 390t video vector, 393À394 visual, 398 Gait assessments, 393 clinical/physical examination, 393 kinematics/kinetics, 394À397 range of motion (ROM), 393 Gas transfer measurement, 250À254 carbon monoxide, 251 screenshot for, 252f single-breath method, 251 spirogram of, 251 Gaussian elimination, 195 Generalized cell structure, 4f Geometric transformations, 161 Global coordinate system (GCS), 402 Glucose regulation, 18À20 Glycoproteins, 4À5 Golgi complex, Good clinical practice (GCP), 34À35 Google’s Android, 380 Grandfather-father-son (GFS) backup rotation, 122 Gravity, 286f Greek medicine, 93À94 H Hazard and operability (HAZOP) study, 87 Healthcare organizations, 81 Healthcare, telecommunications remote access, 385 telecare, 385 telehealth, 385 videoconferencing, 385 Health level seven (HL7), 128À130 HL7 v2.4 message, 129f Health technology management (HTM) system, 43 clinical engineering department (CED), 45À46 clinical engineers, 45 device-specific equipment support plans, 48À49 evaluating effectiveness, 53À54 external maintenance programs, contracting, 51 financial control, 52À53 HTM program, 43, 47f, 100À101 hospitals, clinical engineers role, 100À101 quality management cycle, 56f in-house maintenance program, implementing, 50À51 medical device committee (MDC), 43À44 medical devices, tactical management of, 44 medical equipment management database, documenting, 52 program aims, objectives, and scope, 46À48 implementation, 45À55 quality improvement plan, 54À55 quality management cycle, 56f resources, assigning, 49À50 Heart basic structure of, 220f pacemaker, 220À221 valve disease, 11 Helen Hayes marker set, 395f 437 INDEX Hemostasis, 15 Hip abduction/adduction, limitations, 301 Hip arthroplasty, 424 Hip flexion, to extension, 298f Hip-knee-ankle-foot orthoses (HKAFOs), 420 Histones, DNA binding, Homeostasis and regulation, 16À17 and renal physiology, 17À18 Homeostasis relative, to temperature regulation, 16f Hospitals, clinical engineers role biomedical engineering, 95À96 clinical engineering activities, 96À101 clinical environment, 97À98 clinical informatics, 97 clinical support, 97 healthcare technology management, 100À101 innovating care processes, 99 medical equipment resources, optimum utilization of, 98 overview of, 93À95 patient focused engineering, 101À103 quality improvement, 99 research and development, 99À100 risk management, 99 supporting and advancing care, 97À100 teaching/training, 98À99 HTML code, 177f, 180f for page containing frames, 183f Human bones, 7f Humanitarian use devices (HUD), 108 Human lungs, 13f Human sandwich, 286f Hypertension, 11 Hypodermis, 309 Hypothesis generation null hypothesis, 24 and testing, 23À24 t/z-test, 24À28 Hypothetical data, 29f I IEC 60601-1, 110 IEC 62304-2006, 113 IEC 80001-1, 109À110 IEC/ISO 90003-2004, 113 ImageJ, 161À162 Immuno function, 14 Incontinence-associated dermatitis (IAD), 310À311 Inductors, 198À199 Inductor symbol, 198f, 199f Inferior vena cava (IVC), 233À234 Inflammation, 15 Information communications technology (ICT), 117 archiving, 122 bandwidth, 123À124 Caldicott committee, 116À117 clinical computing, regulation of, 107À117 clinical device, computer uses, 107À109 FDA regulations, 108 MHRA, 107À108 recalls, 109 data exchange protocols, 126À130 DICOM, 126À128 health level seven (HL7), 128À130 hospital administration system, 130 overview of, 126 Data Protection Act, 113À117 data security requirements access control, 120 encryption, 119À120 firewalls, 117À118 human factor, 120À121 information communications technology security, 117À121 malware, 118À119 Freedom of Information Act 2000 (FOI), 115À116 information governance (IG), 124À126 infrastructure, 124 RAID, resilience using, 122À123 regulatory standards CE marking, 111À113 IEC 601, 109À110 IEC 60601-1, 109À110 medical devices directive, 110À111 server/database replication, 121À124 Information governance (IG), 124À125 Information Governance Statement of Compliance (IGSoC), 125 Informed consent elements, 36f In-shoe pressure measurement system, 397f Instrumentation, basic circuit design, 202À206 amplifier, 205À206 Op-amp, signal, 203 difference amplifier, 203À204 voltage divider, 202À203 Intensive therapy units (ITU), 78 Interface pressures, 318t measurements critical evaluation of, 315t sources of variability, 316t International Society of Electrophysiology and Kinesiology (ISEK), 237À238 International Standard ISO 14971:2007, 90 Interstitial pressures, 318t Intrathecal baclofen (ITB), 305À306 iPad with Sensory Software’s Grid Player app, 368f iPortal, 374f ISO 13485-2003 Medical devices, 113 ISO 14971:2007 Medical devices, 109 production/post-production information, 86 risk analysis, 83À84 risk control, 84À85 risk evaluation, 84 risk management policy, 82À86 risk management report, 85 ISO 14971 standard states, 83 J Japan pharmaceutical manufacturers association (JPMA), 35 JavaScript, 137, 179f for generating password prompt, 186f Java virtual machine (JVM), 150 Joint coordinate system (JCS), 403 K Keyboards, range of, 371f Key performance indicators (KPIs), 53 Kidneys, 17 blood content, 17À18 mechanism of regulation, 17f modulate fluid removal, 11 stones, 22 438 Kinematics/kinetics gait analysis, 394À397 global coordinate system (GCS), 402 inverse dynamics, 404À405 limitations of, 405À406 mature, 396f presentation of, 397 segment/joint coordinate systems, 402À404 Kirchhoff’s voltage laws, 195 Knee-ankle-foot orthosis (KAFO), 418À419 Knee arthroplasty, 424 Korotkoff sounds, 230 Krebs cycle, 19 L Laplace transform, 206À207 Laser Doppler fluxmetry, 316À317 LCD display, 89À90 Leaders power change/opportunity, 76 expertise, 74À75 information, 76 interpersonal skill, 75À76 positional, 74 resource control, 75 understanding, 73À76 seven habits of, 66À71 begin with end in mind, 68À69 be proactive, 67À68 put first things first, 69 seek first to understand, 70 sharpen the saw, 70À71 synergize, 70 think win-win, 70 Leadership definition, 61À62 inner/outer, symbol, 60f overview of, 59À61 skills, qualities, abilities, and attributes, 60 Left ventricular pressure, 233f Leg free body diagrams, 404f juxtaposition, 11 Legislation wall, of safety, 80f Leptin, 19À20 Leukocytes, 14 Lilliefors test, 24À25 Lilly pneumotachometer, 246 Linux, 142 INDEX Listening challenges of, 67t levels, 64À66 content, 64À65 feelings, 65 intentions, 65 making visible, 66 right environment, creating, 66 Literature referencing, 30À31 Literature searching, 30À31 Local coordinate system (LCS), 402 Low pass filter resistor capacitor network, 207f Lung alveoli, structure of, 13f Lung lymphoid tissue synthesizes immunoglobulins, 14 Lung, physiological measurements of, 245t Lung volumes/capacity definitions and abbreviations, 244t Lynx, 339À341 M Mac OS X, 377f Magnetic resonance (MR) imaging, 313 Management, 61À62 Mann-Whitney test, 28 Many-to-many relationship, 157 Marker sets, 402À403 MATLAB (statistics toolbox), 24 Maze tracing, 166t Mean time to failure (MTTF), 84 Mechanical/electromechanical devices aids for daily living, 407À411 bathing, 408 dressing, 408 eating/drinking, 408 occupational therapists, 407 orthotics, 417À421 ankle-foot, 419 biomechanical principles, 418 foot, 418À419 functions, goals, and design, 418 head orthoses, 420À421 hip-knee-ankle-foot orthoses, 420 knee-ankle-foot orthoses, 419À420 terminology, 418 thoracolumbar sacral orthoses, 420 upper limb orthoses, 420 personalized devices, 409À411 potential pitfall, 411 prosthetics, 411À417 alignment, 416 amputee gait, 416 construction, 414 demography, 411 lower limb prostheses, 414À416 post-amputation management, 412 pre-amputation and surgery, 411À412 prostheses, 412 sockets, 412À414 upper limb prostheses, 417 toileting, 408 writing/drawing, 409 Mechanical index (MI), 223 Medical device committee (MDC), 43À44 Medical device management system (MDMS), 52 Medical devices classification of, 36À37, 37t clinical investigations, 36À37 competent authorities, 40t clinical investigator responsibilities, 38À39 decision diagram, 112f ISO 14155 standard, 37À39 sponsor responsibilities, 38 Medical devices directive (MDD), 80À81, 107 categorization of, 268 CE marking, 268À269 purpose of, 268 regulatory process, 269 rehabilitation, 267À269 requirements, 269 risk management, 269À274 clinical context, 274 definitions/process, 270À271 fault detection, 272 identifying and analyzing failures/faults, 272À273 rating likelihood/severity, 271À272 Medical device trials, phases of drug, 34t Medical electronics, 193À201 away from ideal, 194À195 bipolar transistor, 199À200 capacitor, 195À198 ceramic capacitors, 197 diode, 199 439 INDEX electrolytic aluminum, 198 field effect transistor, 201 film capacitors, 198 inductors, 198À199 metal/carbon film resistor, 194 network and circuit analysis, 195 operational amplifier, 201 resistor, 193À195 tantalum, 198 thin film/thick film, 194 transistor, 199À201 Medical engineering design, 264À267 concept design, 265À266 documentation, 267 embodiment design, 266À267 preliminary/definitive layout, 266À267 task, clarification of, 265 verification/validation, 267 Medical IT network, 113 Medical subject headings (MeSH), 30 Medicinal products, clinical investigations, 36À37 Medicines and healthcare products regulatory agency (MHRA), 39, 81 MEDLINE filter, 31 Medulla oblongata, 17 MegaBee, 366f Metal carbon film resistor, 194f MFC, nonprocedural code, 145f Mice, range of, 371f Microcontrollers, 150 Microsoft Excel, 28À29 Microsoft SQL Server, 184 Microsoft Windows, 133À134 Mid-wheel drive (MWD), 352 Mimics, 162 Mobile arm supports (MAS), 425À428 applicable client groups, 426 assessment/trial, 426À427 contraindications, 427 device comprises, 425 ongoing care, 427À428 setting up, 427 Mobility See Wheelchair assessment, mobility basic devices, 324 and children, 325 environmental issues and adaptation, 324À325 historical context, 323À324 scooters, 325 Monte Carlo analysis, 86 Motor neurone disease (MND), 381, 426 Motor unit action potential (MUAP), 237 Multiple sclerosis (MS), 426 Muqauj, 187 Muscle fatigue, 238 in EMG signal, 238 stimulation frequency, 277f Muscle physiology, 9À10 Muscle response desired, 280 generation, 280À281 stimulation frequency, 277f stimulation intensity, 277f Muscles fibers, 10 Muscular dystrophy (MD), 426 MYCIN system, 167 MySQL, 173, 182 N National centre for biotechnology information (NCBI), 30 National Institute for Health and Clinical Excellence (NICE), 108 National metrology institute (NMI), 214 National Pressure Ulcer Advisory Panel (NPUAP), 310 Neater Eater, 409f Nerve cell, structure of, 9f Nerve conduction, 236À237 Nerve physiology, 9À10 Nerves, desired response, 280 Nervous systems, sympathetic/ parasympathetic, 10t Network address translation (NAT), 172 Network-attached storage (NAS), 123 NeuFlex, 422 Neural networks, 167 Neurological measurement, 286 electrode construction, 236 electromyography (EMG), 235À239 EMG/nerve conduction studies, 236À237 evoked potentials brainstem auditory evoked potentials (BAEPs), 241 electroencephalography (EEG), 239À240 pattern shift visual evoked potentials (PSVEPs), 240À241 short latency somatosensory evoked potentials, 241 kinematic EMG, 237À239 Newton’s second law, 404 Noncollision-based channels, 124 Noninvasive blood pressure (NIBP) monitors, 230 Nonparametric tests, 28 Normal probability plot, histogram of, 26f Norton equivalent circuit, 195, 196f Nutrition, 18À20 O Observational gait analysis (OGA), 393À394 scoring/notation systems, 394 Observational studies blinding, 23 randomization, 22 types of, 21 Ohm’s law, 201À202 Op-amp, 201f Open systems interconnection (OSI), 128À130 Operating system (OS), 133 Orthopedic biomechanics, 286 common orthopedic implants, 423À425 device fixation, approaches, 422À423 mechanical load requirements, 422 orthopedic implants, engineering requirements of, 421 synthetic biomaterials, use of, 421À422 Orthopedic engineers, 257 Orthotics, 417À421 ankle-foot, 419 biomechanical principles, 418 foot, 418À419 functions, goals, and design, 418 head orthoses, 420À421 hip-knee-ankle-foot orthoses, 420 knee-ankle-foot orthoses, 419À420 terminology, 418 thoracolumbar sacral orthoses, 420 upper limb orthoses, 420 Oscillometric measurements, 230 Oscillometric noninvasive blood pressure measurement, 231f 440 Osteoclasts, Output-based specification (OBS), 151 Oxygen consumption (VO2), 232À233 P p value, 24 Pancreas, 18À20 Patient administration system (PAS), 130 Patient assessment clinical methodology, using, 259À260 communication, principles of, 258À262 fitting/equipment challenging behavior, 261À262 for children, 260 consent to assessment/treatment, 261 documentation, 262 learning potential, 261 outcome measures, 262 to person, 260 provision, aim of, 260À261 groups and characteristics, 262À263 involving the person, 258À259 prescription, 260 time, 258 Patient sliding, in bed, 288f Pattern shift visual evoked potentials (PSVEPs), 240À241 Pearson’s correlation coefficient, 28À29 Pedicle screw, and rod assembly, 424f Pelvic obliquity, 292f Pelvic/trunkal asymmetry, 296À301 lying, 300À301 fixed kyphosis, 300 fixed scoliosis, 300 hip abduction/adduction, 300 hip extension, 300 knee extension, 300 pelvic asymmetry, 300 measurements reasons, 296À297 physical assessment, 297 sitting, 297À300 ankle dorsiflexion/plantarflexion, 299 hip abduction, 298 hip adduction, 298 hip flexion, 297À298 hip rotation, 298À299 knee extension, 299 INDEX neck flexion/extension, 300 spinal asymmetry, 299À300 standing, 301 hip abduction/adduction, 301 hip/knee extension, 301 Peripheral nervous system, 9À10 Personal computing, rise/fall of, 379f Personalized lying support design, 410f PHP, 184, 185f Physiological cost index (PCI), 399 Physiotherapy, 297 Picture archiving and communication system (PACS), 122 Planned preventative maintenance (PPM), 168À169 Point-of-care technologies, 385 Polyaryletheretherketone (PEEK), 422 Polyethylene, 422 Polymorphism, 147 Portable appliance test (PAT), 168À169 Positron emission tomography (PET), 381 Posterior superior iliac spine (PSIS), 291 PostgreSQL, 180 Posture management biomechanics, 287À290 day-to-day clinical applications, 290 elasticity/plasticity, 288À289 inertia, 288 moments, 289 shearing forces, 287À288 stability/instability, 288 stress/strain, 288À289 complementary interventions, 305À306 functional seated posture, 301À302 good and bad, 285À286 gravity effects, 286 modeling, 301À302 overview of, 285 physical assessment process, 290, 302 rationale, 302À306 recommendations, 302À306 lying, 303À304 setting objectives, 302 secondary complications, 306À307 standing, 304À305 supporting surface, roles, 287 24-hour postural management, 287 Powered wheelchairs, 382 add-on power packs, 357 adjustment to position, 353 assistance to manualwheelchairs, 357 categories, 351 chin joystick and inte-grated access, 356f clinical assessment, aspects, 353À354 control interfaces, 354À355 control options, selection of, 354f joysticks, 355 postural management, 351À352 push-rim activated power-assisted wheelchair (PAPAW), 357 specialized controls, 355À357 wheel layouts, 352À353, 352f Preload recruitable stroke work (PRSW), 233À234 Pressures, physiological measurements of, 229 Pressure ulceration, skin/soft tissues, 309À310 Pressure ulcers (PUS), 310À311 care quality, 312À314 collagen fibers, 309 elastin fibers, 309À310 epidermal tissues, 310À311 extrinsic factors, 314 financial implications, 312À314 glycosaminoglycans, 310 interface pressure mapping, 315À317 loaded soft tissues, internal mechanical state, 317À318 pathogenesis of, 312À314 patient-support interface, mechanical loading, 314À315 pressure relief regimens, 318 support surfaces, 318 Pretty good privacy (PGP), 119 Prioritizing your activities, 69t Probability impact grid, 91t Procedural, Object-Oriented and Functional Programming, 136 Prosthetics, 411À417 alignment, 416 amputee gait, 416 construction, 414 demography, 411 lower limb prostheses, 414À416 441 INDEX post-amputation management, 412 pre-amputation and surgery, 411À412 prostheses, 412 sockets, 412À414 transradial hook/cosmesis, 417f upper limb prostheses, 417 Proximal isovelocity surface area (PISA), 224 PubMed, 30À31 Pulmonary artery catheter, 232À233 Pulmonary capillary, a wedge pressure (PCWP), 232À233 Pulmonary physiology, 11À14 Pulmonary vascular resistance index (PVRI), 232À233 Pulsed wave (PW), 222 Pulse repetition frequency (PRF), 222 Purkinje fibers, 220À221 Push-rim activated power-assisted wheelchair (PAPAW), 357 Q Quality assurance (QA), 223 Quality improvement plan (QIP), 54 template, 55f Quality management system (QMS), 82À83 R RAGB grading, 91t RAID controller, 122À123, 123f Randomization, 22 RC circuit, 196f Reference information model (RIM), 129 Regression, 28À30 Regulations, 267À274 Regulatory approvals undertaking research, 39 Rehabilitation, 263À264 medical devices directive, 267À269 Rehabilitation engineering, 257 Rehabilitation healthcare, 411 Rehabilitation therapy, 429 Relational database, 155, 159 Remote access, 120, 385 Renal physiology and homeostasis, 17À18 Renal system, 17À18 Research ethics committee (REC), 39 Research methodology correlation and regression, 28À30 Residual volume (RV), 245 Resistor, 193À195 carbon film, 194 symbol and variety of devices, 194f thin film, 194 Respiratory gas transfer, 250À254 lung conditions, 245À246 lung volumes/physiological parameters, 243 overview of, 243 reference values, 246 spirometry, 246À247 volume conversions, 243À245 whole body plethysmography, 247À250 Restrictive diseases, 245À246 Reticuloendothelial system (RES), Reynolds number, 229, 246 RFID systems, 98 Risk acceptability, 80 Risk appetite, 79 Risk assessment guideline likelihood ratings for, 271f guideline severity rating, 272f matrix, 270f Risk control, hierarchy of, 86f Risk management, 267À274, 273f consequences, 78 definition of, 77À78 likelihood, 78 overview of, 77 review process, 82f risk, third dimension of, 78À79 Risk map, 91t Risk matrix, 85t Risk rating numbers, 85t Risk, three-dimensional model of, 60f, 79f Risk tools, 86À91 hazard and operability study, 87À90 definition, 87 design description, 88 documentation, 90 examination meetings, 89À90 guide words/deviations, 88À89 preparation, 87À89 probability impact grid, 90 RAGB status, 91 risk map, 90À91 Monte Carlo modeling, 86À87 risk estimation, 87 Robot arm, 429f Robotics assistive, 428 definitions, 428 exoskeletons, 430 therapy, 429À430 S Sagittal pelvic angle, 291 SASEA language characteristics, 135t Scolioses, 293 Scoliotic curve complex, 294f simple, 294f Scopus, 30 Screenshot illustrating video vector lines, 394f Security, 185À189 limiting access, 185À186 public/private key encryption, 186À189 Segment coordinate system (SCS), 402À403 SELECT command, 159 Self-awareness, 62À63 SENIAM guidelines, 398 Sensorimotor rhythms, 382 Sensors, 383 Sequential programming, 149f Serious adverse events (SAEs), 36 Severe idiopathic respiratory distress syndrome (SIRDS), 25À26 ShapeLock, 376f Short-time Fourier transforms (STFT), 238À239 Signal analysis, 238À239 Signal-to-noise ratio (SNR), 213 Signal, with common mode noise, 204f Silicone/polyurethane based liners, 414 Silver chloride electrocardiograph (ECG) electrodes, 223À224 Single-breath gas transfer measurements, 253À254 Sinoatrial (SA) node, 220 SIRDS data set, 28 Skeletal physiology, 7À9 Skin pressure ulceration, 309À310 surface stimulation electrodes, 276f SmartNav head tracker, 370f Snell’s law, 221À222 Social awareness, 63 442 Socket design, 412 Soft tissues, pressure ulceration, 309À310 Software coding and coding management, 154À155 Software configuration management (SCM), 154 Software engineering coding management, 136À138 databases, 155À160 development and management, 133À160 embedded system programming, 149À151 functional programming, 147À148 image processing software, 160À162 artificial intelligence (AI), 163À167 device tracking systems, 169 equipment management database systems, 167À169 finite element analysis, 162À163 IDL, 162 MATLAB, 162 packages, 161À162 terminology, 161 incremental model/prototyping model, 142À143 language selection, 134À136 life cycle models, 139À144 Linux, 134 Microsoft Windows, 133À134 object-oriented programming, 144À148 operating systems, 133À134 procedural programming, 144À148 real-time system programming, 148À149 requirements specification, 139À140 software design, 140 software development and coding, 140À141 software maintenance, 142 software quality assurance (SQA), 153À155 software testing, 141À142 spiral model, 143À144 UNIX, 134 validation/verification, 151À153 waterfall model, 142 Software maintenance, 142 Software quality assurance (SQA), 139À140, 153 INDEX Software requirements specification (SRS), 140 Software testing, 141À142 Software validation and verification, 153À154 Solid-ankle-cushioned-heel (SACH) foot, 415À416 Source code control system (SCCS), 142 Speech recognition software, 372 Spinal cord injury (SCI), 426 Spinal muscular atrophy (SMA), 426 Spinal orthoses (TLSOs), 420 Spinal postures, 307 Spiral model, 143À144, 143f Spirometry, 244f, 246À247 Spreadsheets, use, 155À160 Sputtering, 194 Standard software packages, 409 Standard static exercise bike, 410f Standard temperature and pressure (STP), 244À245 Statistical tests, with clinical examples, 29t Statutory instrument, 80À81 sText, 145À146 Storage area network (SAN) technology, 123 Strain/time curve, 289f Stroke/seizure, 11 Structured query language (SQL), 159 Substitution cipher, 187 Supramalleolar orthoses (SMOs), 418À419 Surface electromyography for the non-invasive assessment of muscles (SENIAM), 237À238 Surface electromyography (sEMG) signal filtering effect, 209f Swan-Ganz catheter, 232À233 Switches, 372f Systemic calcium levels, control, 16f System vascular resistance index (SVRI), 232À233 T T-bar/trough, 426f Tecla, 380f Telecare, 385 Telecommunications in the provision of healthcare, 383À384 Thermal conductivity detector (TCD), 253f Thermal index (TI), 223 Thermoplastic molds, 341 The´venin equivalent, 196f circuits, 195 rule, recalling, 199 voltage divider, 202f Thick film, 194 Think win-win, 70 Thoracic gas volume (TGV), 248 Thoracic kyphosis, 294f Thrombosis, 15 Throughput versus offered traffic curve, 124f Titles, for engineers, 257 Total heart beat index (THBI), 399 Total knee arthroplasty device, 424f Total lung capacity (TLC), 245 Touch-enabling devices, 376 Touchscreens, 371 Transfemoral prosthesis, 415f Transfer function, 206À207 Transfer RNA (tRNA) molecule, Transistor family, 201f Transitional flow, 229 Transtibial prosthesis, with cosmesis, 415f Transverse pelvic angle, 291 Tricuspid valves, 220 Trim methods, 195f Turing test, 165 Two-piece foam lying support, 409f U Ultra-high molecular weight polyethylene (UHMWPE), 422 Unified modeling language (UML), 140 UNIX-like operating systems, 134, 171 UPDATE statement, 160 V Vascular nervous system, 10 Vascular physiology, 11 circulatory system, morbidies of, 11 Vasopressin mechanism See antidiuretic hormone (ADH) mechanism Veer, 354 Veins, 12f Ventricles contract, 10 Ventricular fibrillation, 225 443 INDEX Videoconferencing, 385 Vigene`re stream cipher, 187 Virtual local area networks (VLANs), 124 Virus technology, 118 Visual Basic (VB), 137 Voice output communication aid (VOCA), 363À364 battery operated, 365À366 GoTalk20 , 366f Voltage divider, 202f W WAMP stack, 171À172 Water balance, 18 Waterfall model, 142, 142f, 143f Web programming, 136, 175À178 dynamic content, 180À182 forms/data, 179À180 interfacing with databases, 182À184 Web technology, 171À175 cloud provisioned server, 174À175 dedicated server, 174 desktop computer, 172 hosting strategies, 171À175 local server real iron, 172À173 virtual machine, 173 managed hosting, 173À174 virtual dedicated server, 174 Wheatstone bridge principles, 231À232 Wheelchair assessment process, 326À329 conceptual ideas, 328À329 factors, 326À327 historical context, 323À324 mobility See Mobility broader picture of, 325À326 environmental issues and adaptation, 324À325 physiotherapy departments, 325 objective setting, 328 prescription, 329 Wheelchair prescription adaptations, 338 arm support, 333À334 back supports, 335 brakes, 333 buggies, 337 castors, 332 comfort chairs, 335À336 foot support, 333 frame/chassis, 331 insurance, 339 maintenance, 339 manual chairs methods of propulsion, 334 push rims, 332 weight of chair, 334 wheels, 331À332 modifications, 338 modular seats, 335 powered seat raise/lower, 338 repairs, 339 seat cushions, 335 self-propulsion biomechanics, 335 special seating, 335 sports chairs, 338 standing wheelchairs, 338 straps/harnesses, 337À338 tilt-in-space, 337 versus recline, 336 and stability, 336À337 transportation, 338À339 Wheelchair stability active wheelchair users, 347 anti-tipping levers/wheels, 348 body configurations, 348 disorders, 348 movement patterns, 348 overview, 345À347 propulsion, 346 risk assessment, 347 stability assessment, 348À349 Wheel layout, 352À353 WHERE clause, 159 while, 137 Whole body plethysmography, 247À248 healthy volunteers, 248f Wide Web Consortium’s (W3C), 182 Windows, 409 Word prediction software, 372 Worm, 118 Wrist hand orthoses (WHOs), 420 Y Young’s modulus, 163 ... engineering for decades Many of the authors are clinical and biomedical engineers working in healthcare and academia and have also acted as trainers and as examiners on the subject As well as possessing.. .CLINICAL ENGINEERING A Handbook for Clinical and Biomedical Engineers AZZAM TAKTAK PAUL GANNEY DAVE LONG PAUL WHITE AMSTERDAM • BOSTON • HEIDELBERG • LONDON NEW YORK • OXFORD • PARIS • SAN... Morris Ladan Najafi East Kent Adult Communication and Assistive Technology (ACAT) Service Fiona Panthi East Kent Adult Communication and Assistive Technology (ACAT) Service Sandhya Pisharody and