MEDICAL INSTRUMENT DESIGN AND DEVELOPMENT: from Requirements to Market Placements -- Contents -- Foreword -- Preface -- Acknowledgment -- 1 System Engineering -- Chapter Organization -- Part I: Theory -- 1.1 Introduction -- 1.2 Problem Formulation in Product Design -- 1.3 The Business Context for Design -- 1.4 The Engineering Product Design Process -- 1.5 System-subsystem Decomposition -- 1.6 The Product Development Life Cycle -- 1.7 Project Management in Product Design -- 1.8 Intellectual Property Rights and Reuse -- Part II: Implementation -- 1.11 The ECG: Introduction
1.11.1 The ECG's diagnostic relevance -- 1.11.2 ECG Types -- 1.12 The ECG Design Problem Formulation -- 1.13 The ECG Business Plan -- 1.13.1 Market Size and Trend -- 1.13.2 Core and Distinctive Features -- 1.14 The ECG Design Process -- 1.14.1 Transverse Activities of the ECG Design Process -- 1.14.2 Core Activities of the ECG Design Process -- 1.15 ECG System-subsystem Decomposition -- 1.15.1 Hardware Platform Decomposition -- 1.15.2 Software Application Decomposition -- 1.16 ECG Product Life Cycle -- 1.16.1 Overcoming Risk of Inadequate Visualization of ECG Signal
1.16.2 Overcoming Risk of Error Fixing in System Integration -- 1.16.3 Overcoming Risks for Non-stable/Unfeasible Requirements -- 1.17 The ECG Development Plan and Project Management -- 1.18 IPR and Reuse Strategy for the ECG -- References -- 2 Concepts and Requirements -- Chapter Organization -- Part I: Theory -- 2.1 Introduction -- 2.2 The Medical Instrumentation Approach -- 2.3 Extraction of Physiological Parameters -- 2.4 Pressure and Flow -- 2.4.1 Blood Pressure -- 2.4.2 Blood Flow and Hemodynamics -- 2.5 Biopotential Recording -- 2.6 Electroencephalography -- 2.7 Electromyography
Part II: Implementation -- 2.8 Introduction -- 2.9 Requirements Management -- 2.10 Medical Instruments Requirements and Standards -- 2.11 ECG Requirements -- 2.12 The Patient Component -- 2.12.1 The Heart's Pumping Function and the Circulatory System -- 2.12.2 Heart Conduction 'Control' System -- 2.13 The ECG Method for Observation -- 2.13.1 Recording the Heart's Electrical Signals -- 2.13.2 ECG Definition and History -- 2.13.3 ECG Standard Method of Observation -- 2.14 Features of the Observations -- 2.14.1 ECG Signal -- 2.14.2 Clinically Significant Signal -- 2.14.3 Power Line Noise
2.14.4 Isoelectric Line Instability -- 2.14.5 Muscle Artifacts -- 2.15 Requirements Related to Measurements -- 2.16 Safety Requirements -- 2.16.1 EMC Performance -- 2.17 Usability and Marketing Requirements -- 2.18 Environment Issues -- 2.19 Economic Requirements -- References -- 3 Biomedical Engineering Design -- Chapter Organization -- Part I: Theory -- 3.1 Design Principles and Regulations -- 3.2 General Design System Model -- 3.3 Pressure and Flow Instruments -- 3.3.1 Blood Pressure Instruments -- 3.3.2 Flow Measurements -- 3.3.3 Measuring Oxygen Concentration -- 3.4 Biopotential Instruments
