Medical Instrument Design and Development

Foreword xv 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