• Semester 5, position 5

Introduction to clinical engineering based on examples (high-quality application of medical technologies and information technologies, quality assurance, implementation of "good medical practice" etc.). Introduction to medical technologies which heavily rely on clinical engineers (i.e. medical imaging, radiation protection, rehabilitation, use of robots, etc.). General introduction to medical equipment. Basics of medical equipment design and maintenance (surgical tables, beds, chairs, etc.). Introduction to medical device maintenance. Introduction to legislation regarding medical device design and maintenance. Maintenance of concrete devices. Basics of medical device maintenance.

Upon successful completion of this course, students will be able to: •To adopt and differentiate operating principles in a clinical setting (ethics, standards, information technology) •To describe the main characteristics and design of the medical devices and define their appropriate applications •To master the design process of medical devices, from the initial idea to the final realization, and manage project planning, project flow and project budget

Good practices regarding work in clinical environment. Ethics, standards and IT. Concept and basic characteristics of medical device. Medical device vs medical equipment. History of medical devices development. Connection between advances in science and development of biomedical apparatus. Medical device classification. Hospitalization and associated medical instrumentation. Medical imaging – clinical applications (benefits, protection and potential hazards). DICOM standard. Endoscopy. Radiography and Computed Tomography. Gamma camera and SPECT. MRI and fMRI. Sonography. NIRS. Body termography. Maintenance definition. Legislation regarding medical device and equipment maintenance. Maintenance organization and planning. Precautions regarding medical device maintenance. Adequate working environment and prerequisites for medical device maintenance. Maintenance of various devices and equipment. Process and design stages of a medical device from an idea to a final product . Literature review: patent survey, marketing survey, setting up the requirements of the application, properties of the components of the device studied. Setting up the schedule, work flow and budget for the project.

Application of gamma camera and PET (at the Clinical Center of Serbia). Ultrasound applications in medicine (at the MMA). Measurement of temperature distribution (in the laboratory). Preparation of material for obtaining a license to use a new clinical equipment/device. Basics of operation and maintenance of a variety of devices at the Institute for Cardiovascular Diseases "Dedinje".

Requirements for attending are defined with curriculum of study program/module.

1. Written course material (handouts). 2. Handbooks (literature) 3. Printed manuals.

Total assigned hours: 30

New material: 8
Elaboration and examples (recapitulation): 4

Auditory exercises: 0
Laboratory exercises: 8
Calculation tasks: 0
Seminar paper: 0
Project: 4
Consultations: 0
Discussion/workshop: 0
Research study work: 0

Review and grading of calculation tasks: 0
Review and grading of lab reports: 0
Review and grading of seminar papers: 0
Review and grading of the project: 3
Test: 0
Test: 2
Final exam: 1

Activity during lectures: 5
Test/test: 20
Laboratory practice: 0
Calculation tasks: 0
Seminar paper: 20
Project: 0
Final exam: 55
Requirement for taking the exam (required number of points): 35

Barbara L. ChristeI: Introduction to Biomedical Instrumentation. Cambridge University Press, 2009.; Myer Kutz (Ed.): Biomedical Engineering and Design Handbook, 2. ed. McGraw-Hill, 2009.