Cover Image

Biomedical Engineering and Design Handbook, Volume 2 /

Show other versions (1)
Bibliographic Details
Main Author: Kutz, Myer (Author)
Corporate Author: McGraw-Hill Companies
Format: eBook
Language:English
Language Notes:In English.
Published: New York, N.Y. : McGraw-Hill Education, [2009].
Edition:2nd edition.
Subjects:
Biomedical engineering > Handbooks, manuals, etc.
Medical instruments and apparatus > Design and construction > Handbooks, manuals, etc.
Biomedical engineering.
Medical instruments and apparatus > Design and construction.
Electronic books.
Online Access:Connect to the full text of this electronic book
Table of Contents:
  • A. ABOUT THE EDITOR
  • B. VISION STATEMENT
  • C. PREFACE
  • D. PREFACE TO THE FIRST EDITION
  • Acknowledgments
  • 1. MEDICAL PRODUCT DESIGN
  • INTRODUCTION/OVERVIEW
  • SCOPE
  • QUALITIES OF SUCCESSFUL PRODUCT DESIGN
  • CONCURRENT ENGINEERING
  • GOALS
  • TEAM/TALENT
  • PLANNING/RESOURCES
  • DEVELOPING USER NEEDS
  • PRODUCT SPECIFICATIONS
  • CONCEPT DEVELOPMENT
  • CONCEPT EVALUATION
  • ARCHITECTURE/SYSTEM DESIGN
  • DETAIL DESIGN
  • DESIGN FOR MANUFACTURE
  • ROLLOUT
  • PROCESS REVIEW
  • PROTOTYPING
  • TESTING
  • DOCUMENTATION
  • TOOLS
  • REGULATORY ISSUES
  • CLOSURE
  • 2. FDA MEDICAL DEVICE REQUIREMENTS
  • INTRODUCTION
  • WHAT IS A MEDICAL DEVICE?
  • WHAT IS FDA?
  • STATUTE AND REGULATIONS
  • WORKING WITH FDA
  • SCOPE OF REGULATION
  • MARKETING CLEARANCE OF MEDICAL DEVICES
  • PREMARKET APPROVAL (PMA)
  • PREMARKET NOTIFICATION [PMN OR 510(k)]
  • COMPARISON TO EU REGULATION
  • MARKETING CLEARANCE OF COMBINATION PRODUCTS
  • TESTING MEDICAL DEVICES ON NONHUMAN ANIMALS AND LIFE FORMS
  • TESTING MEDICAL DEVICES ON HUMAN SUBJECTS
  • QUALITY SYSTEM REGULATION
  • MEDICAL DEVICE REPORTING
  • 3. OVERVIEW OF CARDIOVASCULAR DEVICES
  • INTRODUCTION
  • ARTIFICIAL HEART VALVES AND RELATED TECHNOLOGIES
  • STENTS AND STENT-GRAFTS: PERCUTANEOUS VASCULAR THERAPIES
  • PACEMAKERS AND IMPLANTABLE DEFIBRILLATORS
  • ARTIFICIAL VASCULAR GRAFTS
  • ARTIFICIAL KIDNEY
  • INDWELLING VASCULAR CATHETERS AND PORTS
  • CIRCULATORY SUPPORT DEVICES
  • ARTIFICIAL LUNG
  • ACKNOWLEDGMENTS
  • 4. DESIGN OF RESPIRATORY DEVICES
  • INTRODUCTION
  • PULMONARY PHYSIOLOGY
  • IMPORTANT PRINCIPLES OF GAS PHYSICS
  • DEVICE COMPONENTS
  • COMMON RESPIRATORY MEASUREMENTS
  • OTHER DEVICES
  • DESIGN OF RESPIRATORY DEVICES
  • 5. DESIGN OF ARTIFICIAL KIDNEYS
  • INTRODUCTION
  • REQUIREMENTS OF AN ARTIFICIAL KIDNEY
  • LOW FLUX VERSUS HIGH FLUX DIALYSIS
  • MEMBRANES FOR DIALYSIS
  • TREATMENT PROTOCOL AND ADEQUACY OF DIALYSIS
  • BIOENGINEERED ARTIFICIAL KIDNEY
  • CONCLUSION
  • 6. DESIGN OF CONTROLLED-RELEASE DRUG DELIVERY SYSTEMS
  • PHYSICOCHEMICAL PROPERTIES OF DRUG
  • ROUTES OF DRUG ADMINISTRATION
  • PHARMACOLOGICAL AND BIOLOGICAL EFFECTS
  • PRODRUG
  • DIFFUSION-CONTROLLED DELIVERY SYSTEMS
  • DISSOLUTION/COATING-CONTROLLED DELIVERY SYSTEMS
  • BIODEGRADABLE/ERODIBLE DELIVERY SYSTEMS
  • OSMOTIC PUMP
  • ION-EXCHANGE RESINS
  • GASTRORETENTIVE DELIVERY SYSTEMS
  • DELIVERY OF MACROMOLECULES
  • CONCLUSION
  • 7. STERILE MEDICAL DEVICE PACKAGE DEVELOPMENT
  • INTRODUCTION
  • REGULATORY HISTORY
  • FUNCTIONS OF A PACKAGE
  • PACKAGE TYPES
  • PACKAGING MATERIALS
  • COMMON TESTING METHODS
  • PACKAGE PROCESS VALIDATION
  • SHELF-LIFE STUDIES
  • FINAL PACKAGE SYSTEM VALIDATION PROTOCOL.
  • 8. DESIGN OF MAGNETIC RESONANCE SYSTEMS
  • INTRODUCTION
  • MR MAGNET CHARACTERISTICS
  • GRADIENT CHARACTERISTICS
  • RADIO-FREQUENCY MAGNETIC FIELD AND COILS
  • OTHER MR SYSTEMS
  • SAFETY STANDARDS
  • NEMA MR MEASUREMENT STANDARDS
  • 9. INSTRUMENTATION DESIGN FOR ULTRASONIC IMAGING
  • INTRODUCTION
  • BASIC CONCEPTS
  • TYPICAL SYSTEM BLOCK DIAGRAM
  • BEAM FORMATION
  • SIGNAL PROCESSING AND SCAN CONVERSION
  • CURRENT TRENDS IN MEDICAL ULTRASOUND SCANNERS
  • SUMMARY
  • 10. THE PRINCIPLES OF X-RAY COMPUTED TOMOGRAPHY
  • INTRODUCTION
  • THE INTERACTION OF X-RAYS WITH MATTER
  • THE MATHEMATICAL MODEL
  • THE MICROTOMOGRAPHY SYSTEM
  • 11. NUCLEAR MEDICINE IMAGING INSTRUMENTATION
  • INTRODUCTION
  • CONVENTIONAL GAMMA RAY IMAGING: SCINTILLATION CAMERA
  • SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY
  • POSITRON EMISSION TOMOGRAPHY
  • SMALL ANIMAL IMAGING
  • SUMMARY
  • 12. BREAST IMAGING SYSTEMS: DESIGN CHALLENGES FOR ENGINEERS
  • INTRODUCTION
  • BREAST ANATOMY
  • CURRENT CLINICAL BREAST IMAGING
  • NEW AND DEVELOPING BREAST IMAGING MODALITIES
  • FUTURE DIRECTIONS
  • 13. SURGICAL SIMULATION TECHNOLOGIES
  • VIRTUAL ENVIRONMENTS: A GENERAL PERSPECTIVE
  • DEVELOPMENTS IN SIMULATION-BASED MEDICAL EDUCATION
  • RESEARCH CHALLENGES IN SURGICAL SIMULATION TECHNOLOGY
  • CONCLUSION
  • 14. COMPUTER-INTEGRATED SURGERY AND MEDICAL ROBOTICS
  • INTRODUCTION: COUPLING INFORMATION TO SURGICAL ACTION
  • AN OVERVIEW OF CIS SYSTEMS
  • THE TECHNOLOGY OF CIS SYSTEMS
  • EXAMPLES OF CIS SYSTEMS
  • PERSPECTIVES
  • BRIEF UPDATE FOR THE SECOND EDITION
  • ACKNOWLEDGMENTS
  • 15. TECHNOLOGY AND DISABILITIES
  • INTRODUCTION
  • CONTROL INTERFACES FOR ELECTRONIC ASSISTIVE TECHNOLOGIES
  • COMPUTER ACCESS BY PERSONS WITH DISABILITIES
  • AUGMENTATIVE AND ALTERNATIVE COMMUNICATION
  • AIDS FOR MANIPULATION
  • FUTURE TRENDS
  • SUMMARY
  • 16. APPLIED UNIVERSAL DESIGN
  • MOTIVATION
  • DESIGN METHODOLOGY
  • SPECIAL TOPICS
  • DESIGN FOR UNDERDEVELOPED REGIONS
  • WHAT?S NEXT?
  • 17. HOME MODIFICATION DESIGN
  • GENERAL CONSIDERATIONS
  • THE KITCHEN
  • THE BATHROOM
  • ACKNOWLEDGMENTS
  • 18. INTELLIGENT ASSISTIVE TECHNOLOGY
  • INTRODUCTION
  • ACTIVITY RECOGNITION
  • ACTIVITY GUIDANCE AND MEMORY SUPPORT
  • NAVIGATION
  • ASSESSMENT
  • 19. REHABILITATORS
  • INTRODUCTION
  • RATIONALE FOR REHABILITATORS
  • DESIGN OF REHABILITATORS
  • THE FUTURE OF REHABILITATORS
  • CONCLUSION
  • 20. THE DESIGN OF ARTIFICIAL ARMS AND HANDS FOR PROSTHETIC APPLICATIONS
  • INTRODUCTION
  • THE NATURE OF THE PROBLEM
  • CONTROL
  • CONCLUSION
  • 21. DESIGN OF ARTIFICIAL LIMBS FOR LOWER EXTREMITY AMPUTEES
  • OVERVIEW
  • HISTORY OF LIMB PROSTHETICS
  • AMPUTATION SURGERY
  • PROSTHETIC CLINIC TEAM
  • PROSTHESIS DESIGN
  • AMPUTEE GAIT
  • RECENT DEVELOPMENTS
  • 22. WEAR OF TOTAL HIP AND KNEE JOINT REPLACEMENTS
  • INTRODUCTION
  • HISTORICAL PERSPECTIVE
  • INTERFACES AND WEAR MECHANISMS
  • CONSEQUENCE OF WEAR
  • FACTORS AFFECTING WEAR IN TOTAL JOINT REPLACEMENTS
  • CONCLUSION
  • A. Bibliography
  • 23. CLINICAL ENGINEERING OVERVIEW
  • BIOMEDICAL ENGINEERING
  • CLINICAL ENGINEERING
  • ROLE OF CLINICAL ENGINEERING
  • FUTURE DEVELOPMENT OF CLINICAL ENGINEERING.
  • 24. RISK MANAGEMENT IN CLINICAL ENGINEERING
  • INTRODUCTION
  • MODEL FOR THE RISK MANAGEMENT PROCESS?MEDICAL DEVICES
  • TOOLS AND TECHNIQUES
  • RISK MANAGEMENT FOR IMPROVING PATIENT OUTCOMES
  • RISK MANAGEMENT FOR MANAGING THE ENTERPRISE
  • CONCLUSION
  • 25. TECHNOLOGY PLANNING FOR HEALTH-CARE INSTITUTIONS
  • PRELUDE
  • INTRODUCTION
  • STRATEGIC PLANNING
  • TECHNOLOGY PLANNING PRINCIPLES
  • THE FOUR CATEGORIES OF TECHNOLOGY PLANNING
  • TECHNOLOGY AND EQUIPMENT PLANNING FOR NEW FACILITIES
  • PROJECT MANAGEMENT
  • FACILITY COMPONENTS
  • BUSINESS CASES
  • PRIORITIES AND FUNDING
  • OUTSOURCING
  • CORPORATE RELATIONSHIPS
  • SUMMARY
  • 26. AN OVERVIEW OF HEALTH CARE FACILITIES PLANNING
  • INTRODUCTION
  • HEALTH CARE FACILITIES PLANNING AND DESIGN
  • KEY POINTS OF INFLUENCE?CHECKLIST FOR MEDICAL TECHNOLOGY INPUT INTO THE HEALTH CARE FACILITIES PLANNING PROCESS
  • 27. HEALTHCARE SYSTEMS ENGINEERING
  • INTRODUCTION
  • SYSTEMS ENGINEERING
  • THE HEALTHCARE DELIVERY ENVIRONMENT
  • COMMUNICATION AND COORDINATION ISSUES
  • CONCLUSION
  • 28. ENCLOSED HABITAT LIFE SUPPORT
  • INTRODUCTION
  • HUMAN COMFORT
  • AIR CONTAMINANTS
  • WATER RECLAMATION
  • NASA SPACE FLIGHT EXPERIENCES
  • SUMMARY.