MEDICAL INSTRUMENT DESIGN AND DEVELOPMENT: from Requirements to Market Placements	1
	Contents	9
	Foreword	17
	Preface	19
	Acknowledgment	23
	1 System Engineering	25
	Chapter Organization	25
	Part I: Theory	28
	1.1 Introduction	28
	1.2 Problem Formulation in Product Design	28
	1.3 The Business Context for Design	30
	1.4 The Engineering Product Design Process	34
	1.5 System-subsystem Decomposition	39
	1.6 The Product Development Life Cycle	45
	1.7 Project Management in Product Design	48
	1.8 Intellectual Property Rights and Reuse	54
	Part II: Implementation	56
	1.11 The ECG: Introduction	56
	1.11.1 The ECG’s diagnostic relevance	56
	1.11.2 ECG Types	57
	1.12 The ECG Design Problem Formulation	58
	1.13 The ECG Business Plan	60
	1.13.1 Market Size and Trend	61
	1.13.2 Core and Distinctive Features	62
	1.14 The ECG Design Process	64
	1.14.1 Transverse Activities of the ECG Design Process	67
	1.14.2 Core Activities of the ECG Design Process	68
	1.15 ECG System–subsystem Decomposition	68
	1.15.1 Hardware Platform Decomposition	69
	1.15.2 Software Application Decomposition	69
	1.16 ECG Product Life Cycle	70
	1.16.1 Overcoming Risk of Inadequate Visualization of ECG Signal	71
	1.16.2 Overcoming Risk of Error Fixing in System Integration	74
	1.16.3 Overcoming Risks for Non-stable/Unfeasible Requirements	74
	1.17 The ECG Development Plan and Project Management	75
	1.18 IPR and Reuse Strategy for the ECG	79
	References	81
	2 Concepts and Requirements	83
	Chapter Organization	83
	Part I: Theory	85
	2.1 Introduction	85
	2.2 The Medical Instrumentation Approach	86
	2.3 Extraction of Physiological Parameters	91
	2.4 Pressure and Flow	94
	2.4.1 Blood Pressure	96
	2.4.2 Blood Flow and Hemodynamics	98
	2.5 Biopotential Recording	103
	2.6 Electroencephalography	105
	2.7 Electromyography	109
	Part II: Implementation	112
	2.8 Introduction	112
	2.9 Requirements Management	113
	2.10 Medical Instruments Requirements and Standards	115
	2.11 ECG Requirements	118
	2.12 The Patient Component	120
	2.12.1 The Heart’s Pumping Function and the Circulatory System	120
	2.12.2 Heart Conduction ‘Control’ System	121
	2.13 The ECG Method for Observation	123
	2.13.1 Recording the Heart’s Electrical Signals	123
	2.13.2 ECG Definition and History	127
	2.13.3 ECG Standard Method of Observation	127
	2.14 Features of the Observations	132
	2.14.1 ECG Signal	132
	2.14.2 Clinically Significant Signal	134
	2.14.3 Power Line Noise	141
	2.14.4 Isoelectric Line Instability	142
	2.14.5 Muscle Artifacts	143
	2.15 Requirements Related to Measurements	143
	2.16 Safety Requirements	150
	2.16.1 EMC Performance	152
	2.17 Usability and Marketing Requirements	155
	2.18 Environment Issues	156
	2.19 Economic Requirements	158
	References	159
	3 Biomedical Engineering Design	161
	Chapter Organization	162
	Part I: Theory	163
	3.1 Design Principles and Regulations	163
	3.2 General Design System Model	165
	3.3 Pressure and Flow Instruments	166
	3.3.1 Blood Pressure Instruments	168
	3.3.2 Flow Measurements	170
	3.3.3 Measuring Oxygen Concentration	171
	3.4 Biopotential Instruments	172
	3.4.1 Electroencephalographs	172
	3.4.2 Electromyographs	175
	3.5 The Design Process	176
	3.5.1 The Conceptual Design	179
	3.5.2 System-wide Design Decisions	180
	3.5.3 System Architectural Design	181
	3.5.4 Risk Management	181
	Part II: Implementation	184
	3.6 ECG-wide Decisions	184
	3.6.1 The Gamma Cardio CG Use Case	184
	3.6.2 Human Factors and the User Interface Design	185
	3.6.3 Patient Interface: the Biopotential Electrodes	191
	3.7 The ECG System Architectural Design	194
	3.7.1 Subsystem Identification	194
	3.7.2 The Communication Interfaces	195
	3.7.3 Acquisition Hardware Requirements	198
	3.7.4 Firmware Requirements	200
	3.7.5 Software Application Requirements	201
	3.7.6 Concept of Execution among Subsystems	202
	3.8 Gamma Cardio CG Technical File Structure	203
	References	204
	4 Signal Processing and Estimation	205
	Chapter Organization	205
	Part I: Theory	208
	4.1 Discrete Representations of Analog Systems	208
	4.2 Discrete Fourier Transform	213
	4.2.1 Discrete Fourier Transform Statistics	218
	4.3 Estimation Theory Framework	221
	4.3.1 Minimum Mean Square Error Estimate	223
	4.3.2 Minimum Mean Absolute Error Estimate (MMAE)	225
	4.3.3 Maximum A Posteriori (MAP) Probability Estimate	226
	4.3.4 Maximum Likelihood Estimation (MLE)	227
	4.4 Performance Indicators	228
	4.4.1 Efficient Estimators	232
	4.4.2 Fisher’s Information Matrix	233
	4.4.3 Akaike Information Criterion	236
	Part II: Implementation	238
	4.5 Analog to Digital Conversion	238
	4.5.1 Indirect Sampling versus Direct Sampling	238
	4.5.2 Quantizer Design	240
	4.6 Signal Denoising	245
	4.6.1 White Gaussian Signals in Additive White Gaussian Noise	245
	4.6.2 Denoising of Gaussian Cyclostationary Signals	246
	4.6.3 MMSE Digital Filter	246
	4.7 Time of Arrival Estimation	248
	References	253
	5 Applied Electronics	255
	Chapter Organization	255
	Part I: Theory	257
	5.0 Architectural Design	259
	5.1 Sensors	260
	5.2 Circuit Protection Function	267
	5.2.1 Johnson Noise	270
	5.2.2 Transient Voltage Suppressors	271
	5.2.3 RF Filter Circuit Protection	272
	5.2.4 Circuit Frequency Response	275
	5.3 Buffer Stage	278
	5.3.1 Operational Amplifiers	280
	5.4 Analog Signal Processing	282
	5.4.1 Summing Amplifier Circuit	283
	5.4.2 Analog Signal Switching	284
	5.5 Interference and Instrumentation Amplifiers	286
	5.5.1 Eliminating In-band Interference	286
	5.5.2 Patient Model	291
	5.5.3 The ECG Model	292
	5.5.4 Right Leg Connection	294
	5.5.5 Right Leg Driver Circuit	296
	5.6 Analog Filtering	297
	5.6.1 Frequency Domain	297
	5.6.2 Analog versus Digital Filtering	302
	5.7 ADC Conversion	303
	5.8 Programable Devices	309
	5.9 Power Module	313
	5.9.1 Power Sources	314
	5.9.2 Electrical Safety and Appliance Design	318
	5.9.3 Power Module Design	322
	5.10 Baseband Digital Communication	325
	5.10.1 Data Transmission Elements	326
	Part II: Implementation	337
	5.20 Gamma Cardio CG Architecture	337
	5.20.1 ECG Design Choices	338
	5.20.2 Gamma Cardio CG Complete Scheme	341
	5.21 ECG Sensors	341
	5.22 Gamma Cardio CG Protection	345
	5.23 Gamma Cardio CG Buffer Stage	349
	5.24 The Lead Selector	351
	5.24.1 Calibration	355
	5.25 ECG Amplification	356
	5.25.1 ECG Circuits	357
	5.25.2 Input Dynamic Range: Requirement Demonstrations	361
	5.25.3 Gain Error: Requirement Demonstrations	362
	5.26 Analog Filtering	363
	5.27 The ADC Circuit	366
	5.28 Programable Devices	370
	5.28.1 Circuit Design	371
	5.28.2 The Clock	372
	5.29 Power Module	375
	5.29.1 Power Module Circuit	377
	5.30 Communication Module	377
	Conclusion	381
	References	382
	6 Medical Software	383
	Chapter Organization	383
	Part I: Theory	385
	6.1 Introduction	385
	6.1.1 Intrinsic Risks and Software Engineering	386
	6.1.2 Main Concepts in Software Development	387
	6.1.3 Regulatory Requirements for Software	388
	6.2 The Process: a Standard for Medical Software	389
	6.2.1 IEC/EN 62304 Overview	389
	6.2.2 Risk Analysis for Hardware and Software Design	392
	6.2.3 Software Safety Classification	394
	6.2.4 System Decomposition and Risks	395
	6.2.5 Impact of Safety Classification	396
	6.2.6 SOUP	396
	6.3 Risk Management Process	398
	6.3.1 Risk Management in Software	400
	6.3.2 Risk Management for Medical Instrument Software	401
	6.4 Software Development Process	403
	6.4.1 Software Development Planning	404
	6.4.2 Software Requirements Analysis	405
	6.4.3 Software Architectural Design	406
	6.4.4 Detailed Software Design	409
	6.4.5 Software Unit Implementation and Verification	409
	6.4.6 Software Integration and Integration Testing	411
	6.4.7 Software System Testing	412
	6.4.8 Software Release	412
	6.5 Software Configuration Management Process	413
	6.6 Software Problem Resolution Process	415
	6.7 Software Maintenance Process	416
	6.8 Guidelines on Software Design	417
	6.8.1 Definitions	419
	6.8.2 Basic Recommendations	420
	6.8.3 Software Core Services	420
	6.8.4 Defensive Programing	422
	Part II: Implementation	424
	6.9 System Decomposition	424
	6.9.1 Gamma Cardio CG Use Case	424
	6.9.2 System Decomposition	425
	6.10 Risk Management	426
	6.11 Software Application	427
	6.11.1 Software Requirements	427
	6.11.2 Architectural Design	431
	6.11.3 Elaboration Module	433
	6.12 Firmware	435
	6.12.1 Firmware Requirements	435
	6.12.2 Architectural Design	437
	6.12.3 Automatic Test Capability	440
	References	442
	7 c-Health	443
	Chapter Organization	444
	Part I: Theory	445
	7.1 Introduction	445
	7.1.1 The Assessment Framework	445
	7.1.2 Assessment Framework for the Health Sector	446
	7.2 The Cloud Computing Model	450
	7.2.1 Basics of Cloud Computing	450
	7.2.2 Cloud Platforms	452
	7.2.3 Services in the Cloud	454
	7.2.4 The Cloud Shape	456
	7.2.5 Features of the Clouds	458
	7.3 e-Health	459
	7.3.1 Interoperability in e-Health	461
	7.4 Electronic Health Record (EHR)	466
	7.5 c-Health	469
	Part II: Implementation	473
	7.6 Telecardiology	474
	7.6.1 Application Scenario	474
	7.7 Telecardiology Technology	475
	7.8 Workflow in Telecardiology	479
	7.8.1 Basic Workflows	479
	7.8.2 Alternative Workflows	481
	7.8.3 Where and When Telecardiology Can Be Used	484
	7.9 Risks of Telecardiology	487
	References	489
	8 Certification Process	491
	Chapter Organization	491
	Part I: Theory	493
	8.1 Certification Objectives and Processes	493
	8.1.1 Certification, Standards and Definitions	494
	8.2 Regulations, Standards and Organizations	498
	8.2.1 Technical Standards for Medical Devices	501
	8.2.2 European Context	502
	8.3 Basic Protection Concepts	504
	8.3.1 Protection Against Electric Shock	504
	8.3.2 Insulation	508
	8.3.3 Degree of Protection Provided by Enclosures	509
	8.4 Verification of Constructional Requirements	510
	8.4.1 Choice of Safety Critical Materials and Components	510
	8.4.2 Creepage Distances and Air Clearances	513
	8.4.3 Markings	514
	8.4.4 Conductors	516
	8.4.5 Connections to the Power Supply	518
	8.4.6 Fire Enclosure	519
	8.5 Medical Equipment Safety Tests	519
	8.5.1 Leakage Current	521
	8.5.2 Heating	523
	8.5.3 Dielectric Strength	524
	8.5.4 Stability and Mechanical Strength	524
	8.5.5 Abnormal Operating and Fault Conditions	525
	8.5.6 Continuity of Protective Earthing	526
	8.5.7 Residual Voltage	527
	8.5.8 Voltage on the Accessible Parts	527
	8.5.9 Energy Stored – Pressurized Part	527
	8.5.10 Current and Power Consumption	528
	8.6 Electromagnetic Compatibility	528
	8.6.1 Emissions	530
	8.6.2 Immunity	535
	8.6.3 The Test Report	537
	Part II: Implementation	539
	8.11 The Process	539
	8.11.1 Device Description	540
	8.11.2 Medical Device Classes	540
	8.11.3 EU Conformity Assessment	543
	8.11.4 Risk Management Deliverable	544
	8.11.5 The Technical File	551
	8.12 Regulatory Approaches to Medical Device Market Placement	561
	8.13 Basic Concepts in Device Implementation	564
	8.13.1 Protection Against Electric Shock	565
	8.13.2 Insulation	565
	8.13.3 Enclosure IP Protection	568
	8.14 Verification on Design Performance	568
	8.14.1 Safety-critical Materials	568
	8.14.2 Creepage and Air Clearance	569
	8.14.3 Other Verifications	569
	8.15 Safety Tests	570
	8.15.1 Leakage Current	570
	8.15.2 Heating	570
	8.15.3 Other Safety Tests	571
	8.16 Electromagnetic Compatibility	572
	8.16.1 Emission	573
	8.16.2 Immunity	574
	References	578
	Summary of Regulations and Standards	579
	Index	583