Medical instrument design and development from requirements to market placements includes a case stu【2025|PDF|Epub|mobi|kindle电子书版本百度云盘下载】

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1 SYSTEM ENGINEERING1

Chapter Organization1

Part Ⅰ：Theory4

1.1 Introduction4

1.2 Problem Formulation in Product Design4

1.3 The Business Context for Design6

1.4 The Engineering Product Design Process10

1.5 System-subsystem Decomposition15

1.6 The Product Development Life Cycle21

1.7 Project Management in Product Design24

1.8 Intellectual Property Rights and Reuse30

Part Ⅱ：Implementation32

1.11 The ECG：Introduction32

1.11.1 The ECG’s diagnostic relevance32

1.11.2 ECG Types33

1.12 The ECG Design Problem Formulation34

1.13 The ECG Business Plan36

1.13.1 Market Size and Trend37

1.13.2 Core and Distinctive Features38

1.14 The ECG Design Process40

1.14.1 Transverse Activities of the ECG Design Process43

1.14.2 Core Activities of the ECG Design Process44

1.15 ECG System-subsystem Decomposition44

1.15.1 Hardware Platform Decomposition45

1.15.2 Software Application Decomposition45

1.16 ECG Product Life Cycle46

1.16.1 Overcoming Risk of Inadequate Visualization of ECG Signal47

1.16.2 Overcoming Risk of Error Fixing in System Integration50

1.16.3 Overcoming Risks for Non-stable/Unfeasible Requirements50

1.17 The ECG Development Plan and Project Management51

1.18 IPR and Reuse Strategy for the ECG55

References57

2 CONCEPTS AND REQUIREMENTS59

Chapter Organization59

Part Ⅰ：Theory61

2.1 Introduction61

2.2 The Medical Instrumentation Approach62

2.3 Extraction of Physiological Parameters67

2.4 Pressure and Flow70

2.4.1 Blood Pressure72

2.4.2 Blood Flow and Hemodynamics74

2.5 Biopotential Recording79

2.6 Electroencephalography81

2.7 Electromyography85

Part Ⅱ：Implementation88

2.8 Introduction88

2.9 Requirements Management89

2.10 Medical Instruments Requirements and Standards91

2.11 ECG Requirements94

2.12 The Patient Component96

2.12.1 The Heart’s Pumping Function and the Circulatory System96

2.12.2 Heart Conduction ‘Control’ System97

2.13 The ECG Method for Observation99

2.13.1 Recording the Heart’s Electrical Signals99

2.13.2 ECG Definition and History103

2.13.3 ECG Standard Method of Observation103

2.14 Features of the Observations108

2.14.1 ECG Signal108

2.14.2 Clinically Significant Signal110

2.14.3 Power Line Noise117

2.14.4 Isoelectric Line Instability118

2.14.5 Muscle Artifacts119

2.15 Requirements Related to Measurements119

2.16 Safety Requirements126

2.16.1 EMC Performance128

2.17 Usability and Marketing Requirements131

2.18 Environment Issues132

2.19 Economic Requirements134

References135

3 BIOMEDICAL ENGINEERING DESIGN137

Chapter Organization138

Part Ⅰ：Theory139

3.1Design Principles and Regulations139

3.2General Design System Model141

3.3Pressure and Flow Instruments142

3.3.1Blood Pressure Instruments144

3.3.2Flow Measurements146

3.3.3Measuring Oxygen Concentration147

3.4Biopotential Instruments148

3.4.1 Electroencephalographs148

3.4.2 Electromyographs151

3.5The Design Process152

3.5.1 The Conceptual Design155

3.5.2 System-wide Design Decisions156

3.5.3 System Architectural Design157

3.5.4 Risk Management157

PartⅡ：Implementation160

3.6ECG-wide Decisions160

3.6.1 The Gamma Cardio CG Use Case160

3.6.2 Human Factors and the User Interface Design161

3.6.3 Patient Interface：the Biopotential Electrodes167

3.7The ECG System Architectural Design170

3.7.1 Subsystem Identification170

3.7.2 The Communication Interfaces171

3.7.3 Acquisition Hardware Requirements174

3.7.4 Firmware Requirements176

3.7.5Software Application Requirements177

3.7.6Concept of Execution among Subsystems178

3.8Gamma Cardio CG Technical File Structure179

References180

4 SIGNAL PROCESSING AND ESTIMATION181

Chapter Organization181

Part Ⅰ：Theory184

4.1 Discrete Representations of Analog Systems184

4.2 Discrete Fourier Transform189

4.2.1 Discrete Fourier Transform Statistics194

4.3 Estimation Theory Framework197

4.3.1 Minimum Mean Square Error Estimate199

4.3.2 Minimum Mean Absolute Error Estimate （MMAE）201

4.3.3 Maximum A Posteriori （MAP） Probability Estimate202

4.3.4 Maximum Likelihood Estimation （MLE）203

4.4 Performance Indicators204

4.4.1 Efficient Estimators208

4.4.2 Fisher’s Information Matrix209

4.4.3 Akaike Information Criterion212

PartⅡ：Implementation214

4.5 Analog to Digital Conversion214

4.5.1 Indirect Sampling versus Direct Sampling214

4.5.2 Quantizer Design216

4.6 Signal Denoising221

4.6.1 White Gaussian Signals in Additive White Gaussian Noise221

4.6.2 Denoising of Gaussian Cyclostationary Signals222

4.6.3 MMSE Digital Filter222

4.7 Time of Arrival Estimation224

References229

5 APPLIED ELECTRONICS231

Chapter Organization231

Part Ⅰ：Theory233

5.0 Architectural Design235

5.1 Sensors236

5.2 Circuit Protection Function243

5.2.1 Johnson Noise246

5.2.2 Transient Voltage Suppressors247

5.2.3 RF Filter Circuit Protection248

5.2.4 Circuit Frequency Response251

5.3 Buffer Stage254

5.3.1 Operational Amplifiers256

5.4 Analog Signal Processing258

5.4.1 Summing Amplifier Circuit259

5.4.2 Analog Signal Switching260

5.5 Interference and Instrumentation Amplifiers262

5.5.1 Eliminating In-band Interference262

5.5.2 Patient Model267

5.5.3 The ECG Model268

5.5.4 Right Leg Connection270

5.5.5 Right Leg Driver Circuit272

5.6 Analog Filtering273

5.6.1 Frequency Domain273

5.6.2 Analog versus Digital Filtering278

5.7 ADC Conversion279

5.8 Programable Devices285

5.9 Power Module289

5.9.1 Power Sources290

5.9.2 Electrical Safety and Appliance Design294

5.9.3 Power Module Design298

5.10 Baseband Digital Communication301

5.10.1 Data Transmission Elements302

PartⅡ：Implementation313

5.20 Gamma Cardio CG Architecture313

5.20.1 ECG Design Choices314

5.20.2 Gamma Cardio CG Complete Scheme317

5.21 ECG Sensors317

5.22 Gamma Cardio CG Protection321

5.23 Gamma Cardio CG Buffer Stage325

5.24 The Lead Selector327

5.24.1 Calibration331

5.25 ECG Amplification332

5.25.1 ECG Circuits333

5.25.2 Input Dynamic Range：Requirement Demonstrations337

5.25.3 Gain Error：Requirement Demonstrations338

5.26 Analog Filtering339

5.27 The ADC Circuit342

5.28 Programable Devices346

5.28.1 Circuit Design347

5.28.2 The Clock348

5.29 Power Module351

5.29.1 Power Module Circuit353

5.30 Communication Module353

Conclusion357

References358

6 MEDICAL SOFTWARE359

Chapter Organization359

Part Ⅰ：Theory361

6.1 Introduction361

6.1.1 Intrinsic Risks and Software Engineering362

6.1.2 Main Concepts in Software Development363

6.1.3 Regulatory Requirements for Software364

6.2 The Process：a Standard for Medical Software365

6.2.1 IEC/EN 62304 Overview365

6.2.2 Risk Analysis for Hardware and Software Design368

6.2.3 Software Safety Classification370

6.2.4 System Decomposition and Risks371

6.2.5 Impact of Safety Classification372

6.2.6 SOUP372

6.3 Risk Management Process374

6.3.1 Risk Management in Software376

6.3.2 Risk Management for Medical Instrument Software377

6.4 Software Development Process379

6.4.1 Software Development Planning380

6.4.2 Software Requirements Analysis381

6.4.3 Software Architectural Design382

6.4.4 Detailed Software Design385

6.4.5 Software Unit Implementation and Verification385

6.4.6 Software Integration and Integration Testing387

6.4.7 Software System Testing388

6.4.8 Software Release388

6.5 Software Configuration Management Process389

6.6 Software Problem Resolution Process391

6.7 Software Maintenance Process392

6.8 Guidelines on Software Design393

6.8.1 Definitions395

6.8.2 Basic Recommendations396

6.8.3 Software Core Services396

6.8.4 Defensive Programing398

Part Ⅱ：Implementation400

6.9 System Decomposition400

6.9.1 Gamma Cardio CG Use Case400

6.9.2 System Decomposition401

6.10 Risk Management402

6.11 Software Application403

6.11.1 Software Requirements403

6.11.2 Architectural Design407

6.11.3 Elaboration Module409

6.12 Firmware411

6.12.1 Firmware Requirements411

6.12.2 Architectural Design413

6.12.3 Automatic Test Capability416

References418

7 C-HEALTH419

Chapter Organization420

Part Ⅰ：Theory421

7.1 Introduction421

7.1.1 The Assessment Framework421

7.1.2 Assessment Framework for the Health Sector422

7.2 The Cloud Computing Model426

7.2.1 Basics of Cloud Computing426

7.2.2 Cloud Platforms428

7.2.3 Services in the Cloud430

7.2.4 The Cloud Shape432

7.2.5 Features of the Clouds434

7.3 e-Health435

7.3.1 Interoperability in e-Health437

7.4 Electronic Health Record （EHR）442

7.5 c-Health445

PartⅡ：Implementation449

7.6 Telecardiology450

7.6.1 Application Scenario450

7.7 Telecardiology Technology451

7.8 Workflow in Telecardiology455

7.8.1 Basic Workflows455

7.8.2 Alternative Workflows457

7.8.3 Where and When Telecardiology Can Be Used460

7.9 Risks of Telecardiology463

References465

8 CERTIFICATION PROCESS467

Chapter Organization467

Part Ⅰ：Theory469

8.1 Certification Objectives and Processes469

8.1.1 Certification，Standards and Definitions470

8.2 Regulations，Standards and Organizations474

8.2.1 Technical Standards for Medical Devices477

8.2.2 European Context478

8.3 Basic Protection Concepts480

8.3.1 Protection Against Electric Shock480

8.3.2 Insulation484

8.3.3 Degree of Protection Provided by Enclosures485

8.4 Verification of Constructional Requirements486

8.4.1 Choice of Safety Critical Materials and Components486

8.4.2 Creepage Distances andAir Clearances489

8.4.3 Markings490

8.4.4 Conductors492

8.4.5 Connections to the Power Supply494

8.4.6 Fire Enclosure495

8.5 Medical Equipment Safety Tests495

8.5.1 Leakage Current497

8.5.2 Heating499

8.5.3 Dielectric Strength500

8.5.4 Stability and Mechanical Strength500

8.5.5 Abnormal Operating and Fault Conditions501

8.5.6 Continuity of Protective Earthing502

8.5.7 Residual Voltage503

8.5.8 Voltage on the Accessible Parts503

8.5.9 Energy Stored - Pressurized Part503

8.5.10 Current and Power Consumption504

8.6 Electromagnetic Compatibility504

8.6.1 Emissions506

8.6.2 Immunity511

8.6.3 The Test Report513

PartⅡ：Implementation515

8.11 The Process515

8.11.1 Device Description516

8.11.2 Medical Device Classes516

8.11.3 EU Conformity Assessment519

8.11.4 Risk Management Deliverable520

8.11.5 The Technical File527

8.12 Regulatory Approaches to Medical Device Market Placement537

8.13 Basic Concepts in Device Implementation540

8.13.1 Protection Against Electric Shock541

8.13.2 Insulation541

8.13.3 Enclosure IP Protection544

8.14 Verification on Design Performance544

8.14.1 Safety-critical Materials544

8.14.2 Creepage and Air Clearance545

8.14.3 Other Verifications545

8.15 Safety Tests546

8.15.1 Leakage Current546

8.15.2 Heating546

8.15.3 Other Safety Tests547

8.16 Electromagnetic Compatibility548

8.16.1 Emission549

8.16.2 Immunity550

References554

Summary of Regulations and Standards555

Index559