Medical Instrument Design and Development
From Requirements to Market Placements
1. Auflage Juli 2013
598 Seiten, Hardcover
Wiley & Sons Ltd
Kurzbeschreibung
This book explains all of the stages involved in developing medical devices, from concept to medical approval, including system engineering, bioinstrumentation design, signal processing, electronics, software and ICT with Cloud and e-Health development. Fully illustrated with hundreds of diagrams, graphics, and tables, the book covers both theory and implementation. It demonstrates how the theory is translated into a medical product using an electrocardiograph (ECG or EKG) as an example, since it encompasses all the main areas involved in developing medical electronic equipment.
This book explains all of the stages involved in developing medical devices; from concept to medical approval including system engineering, bioinstrumentation design, signal processing, electronics, software and ICT with Cloud and e-Health development.
Medical Instrument Design and Development offers a comprehensive theoretical background with extensive use of diagrams, graphics and tables (around 400 throughout the book). The book explains how the theory is translated into industrial medical products using a market-sold Electrocardiograph disclosed in its design by the Gamma Cardio Soft manufacturer. The sequence of the chapters reflects the product development lifecycle. Each chapter is focused on a specific University course and is divided into two sections: theory and implementation. The theory sections explain the main concepts and principles which remain valid across technological evolutions of medical instrumentation. The Implementation sections show how the theory is translated into a medical product. The Electrocardiograph (ECG or EKG) is used as an example as it is a suitable device to explore to fully understand medical instrumentation since it is sufficiently simple but encompasses all the main areas involved in developing 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 (using ECG as an example)
* Examines the design and applications of main medical instruments
* Details the additional know-how required for product implementation: business context, system design, project management, intellectual property rights, product life cycle, etc.
* Includes an accompanying website with the design of the certified ECG product (www.gammacardiosoft.it/book)
* Discloses the details of a marketed ECG Product (from Gamma Cardio Soft) compliant with the ANSI standard AAMI EC 11 under open licenses (GNU GPL, Creative Common)
This book is written for biomedical engineering courses (upper-level undergraduate and graduate students) and for engineers interested in medical instrumentation/device design with a comprehensive and interdisciplinary system perspective.
Preface xvii
Acknowledgment xxi
1 SYSTEM ENGINEERING 1
Chapter Organization 1
Part I: Theory 4
1.1 Introduction 4
1.2 Problem Formulation in Product Design 4
1.3 The Business Context for Design 6
1.4 The Engineering Product Design Process 10
1.5 System-subsystem Decomposition 15
1.6 The Product Development Life Cycle 21
1.7 Project Management in Product Design 24
1.8 Intellectual Property Rights and Reuse 30
Part II: Implementation 32
1.11 The ECG: Introduction 32
1.12 The ECG Design Problem Formulation 34
1.13 The ECG Business Plan 36
1.14 The ECG Design Process 40
1.15 ECG System-subsystem Decomposition 44
1.16 ECG Product Life Cycle 46
1.17 The ECG Development Plan and Project Management 51
1.18 IPR and Reuse Strategy for the ECG 55
References 57
2 CONCEPTS AND REQUIREMENTS 59
Chapter Organization 59
Part I: Theory 61
2.1 Introduction 61
2.2 The Medical Instrumentation Approach 62
2.3 Extraction of Physiological Parameters 67
2.4 Pressure and Flow 70
2.5 Biopotential Recording 79
2.6 Electroencephalography 81
2.7 Electromyography 85
Part II: Implementation 88
2.8 Introduction 88
2.9 Requirements Management 89
2.10 Medical Instruments Requirements and Standards 91
2.11 ECG Requirements 94
2.12 The Patient Component 96
2.13 The ECG Method for Observation 99
2.14 Features of the Observations 108
2.15 Requirements Related to Measurements 119
2.16 Safety Requirements 126
2.17 Usability and Marketing Requirements 131
2.18 Environment Issues 132
2.19 Economic Requirements 134
References 135
3 BIOMEDICAL ENGINEERING DESIGN 137
Chapter Organization 138
Part I: Theory 139
3.1 Design Principles and Regulations 139
3.2 General Design System Model 141
3.3 Pressure and Flow Instruments 142
3.4 Biopotential Instruments 148
3.5 The Design Process 152
Part II: Implementation 160
3.6 ECG-wide Decisions 160
3.7 The ECG System Architectural Design 170
3.8 Gamma Cardio CG Technical File Structure 179
References 180
4 SIGNAL PROCESSING AND ESTIMATION 181
Chapter Organization 181
Part I: Theory 184
4.1 Discrete Representations of Analog Systems 184
4.2 Discrete Fourier Transform 189
4.3 Estimation Theory Framework 197
4.4 Performance Indicators 204
Part II: Implementation 214
4.5 Analog to Digital Conversion 214
4.6 Signal Denoising 221
4.7 Time of Arrival Estimation 224
References 229
5 APPLIED ELECTRONICS 231
Chapter Organization 231
Part I: Theory 233
5.0 Architectural Design 235
5.1 Sensors 236
5.2 Circuit Protection Function 243
5.3 Buffer Stage 254
5.4 Analog Signal Processing 258
5.5 Interference and Instrumentation Amplifiers 262
5.6 Analog Filtering 273
5.7 ADC Conversion 279
5.8 Programable Devices 285
5.9 Power Module 289
5.10 Baseband Digital Communication 301
Part II: Implementation 313
5.20 Gamma Cardio CG Architecture 313
5.21 ECG Sensors 317
5.22 Gamma Cardio CG Protection 321
5.23 Gamma Cardio CG Buffer Stage 325
5.24 The Lead Selector 327
5.25 ECG Amplification 332
5.26 Analog Filtering 339
5.27 The ADC Circuit 342
5.28 Programable Devices 346
5.29 Power Module 351
5.30 Communication Module 353
Conclusion 357
References 358
6 MEDICAL SOFTWARE 359
Chapter Organization 359
Part I: Theory 361
6.1 Introduction 361
6.2 The Process: a Standard for Medical Software 365
6.3 Risk Management Process 374
6.4 Software Development Process 379
6.5 Software Configuration Management Process 389
6.6 Software Problem Resolution Process 391
6.7 Software Maintenance Process 392
6.8 Guidelines on Software Design 393
Part II: Implementation 400
6.9 System Decomposition 400
6.10 Risk Management 402
6.11 Software Application 403
6.12 Firmware 411
References 418
7 C-HEALTH 419
Chapter Organization 420
Part I: Theory 421
7.1 Introduction 421
7.2 The Cloud Computing Model 426
7.3 e-Health 435
7.4 Electronic Health Record (EHR) 442
7.5 c-Health 445
Part II: Implementation 449
7.6 Telecardiology 450
7.7 Telecardiology Technology 451
7.8 Workflow in Telecardiology 455
7.9 Risks of Telecardiology 463
References 465
8 CERTIFICATION PROCESS 467
Chapter Organization 467
Part I: Theory 469
8.1 Certification Objectives and Processes 469
8.2 Regulations, Standards and Organizations 474
8.3 Basic Protection Concepts 480
8.4 Verification of Constructional Requirements 486
8.5 Medical Equipment Safety Tests 495
8.6 Electromagnetic Compatibility 504
Part II: Implementation 515
8.11 The Process 515
8.12 Regulatory Approaches to Medical Device Market Placement 537
8.13 Basic Concepts in Device Implementation 540
8.14 Verification on Design Performance 544
8.15 Safety Tests 546
8.16 Electromagnetic Compatibility 548
References 554
Summary of Regulations and Standards 555
Index 559
Claudio Becchetti graduated with honors in Electronic Engineering in 1994 at the University of Rome, where he achieved the Ph.D. in Telecommunications in 1999. From 2002 to 2009, he was adjoint professor at the University "La Sapienza", faculty of Telecommunication Engineering where he held first a course on Industrial design and then a course on Signal Theory. Claudio has 7 years teaching experience working with students studying ECG. This device is well suited as a practical example for signal theory, digital signal processing, electronics and software engineering.
Professor Alessandro Neri, University of Roma TRE, Italy
Alessandro Neri he received the Doctoral Degree cum laude in Electronic Engineering from the University of Rome "La Sapienza" in 1977. Since 1992 he is responsible for coordination and management of research and teaching activities in the Telecommunication fields at the University of Roma TRE, currently leading the Digital Signal Processing, Multimedia & Optical Communications at the Applied Electronics Department. His research activity has mainly been focused on information theory, signal theory, and signal and image processing and their applications to both telecommunications systems and remote sensing.
