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Medical Instrument Design and Development From Requirements to Market Placements

Claudio. Becchetti Alessandro Neri

Hoboken : Wiley 2013

Online access

  • Title:
    Medical Instrument Design and Development From Requirements to Market Placements
  • Author: Claudio. Becchetti
  • Alessandro Neri
  • Subjects: Electrical equipment and supplies; Electrocardiography -- Instrumentation; Equipment design -- Methods; Equipment safety; Software; Electronic books
  • Contents: 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 Types1.12 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 Requirements1.17 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 Standards2.11 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 Requirements2.16.1 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; 3.4.1 Electroencephalographs; 3.4.2 Electromyographs; 3.5 The Design Process; 3.5.1 The Conceptual Design
    3.5.2 System-wide Design Decisions
    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 ;Description based upon print version of record.
  • Publisher: Hoboken : Wiley
  • Creation Date: 2013
  • Physical Description: 1 online resource (600 p.).
  • Language: English
  • Identifier: ISBN1-118-65246-0;ISBN1-118-65245-2
  • Source: 01GALI USG ALMA
  • OCLC Number: 826324808
  • NZ MMS ID: 9913746473902931
  • IZ MMS ID: 9913664239502961$$IUWG

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