Reliability, Design and Development of Medical Systems

Lecturer:

Tutor:

Supervisor:

Department of Radioelectronics

Synopsis:

Probability measures, random processes and random distributions used in diagnostics. Elem. properties in reliability theory, tools for system diagnostics, real process sampling. Reliability of single elements and complex systems. Evaluation of composite reliabilities for complex systems. System backup. Systems with time-dependent failure rates. From the point of view of design and development of medical devices and systems there are included the following main topics: safety regulations of medical devices production, classification and structure of medical devices, design process, modern electronic elements, properties, selection and application rules, electromagnetic compatibility of medical devices and design and development of elementary electronic functional blocks of medical devices.

Requirements:

Syllabus of lectures:

1. Elem. properties in reliability theory, tools for system diagnostics, real process sampling and experiment planning

2. Probability measures, random processes and random distributions used in diagnostics

3. Reliability of single elements and complex systems, systems with unrecoverable elements

4. Evaluation of composite reliabilities for complex systems - methods survey

5. System backup, methods and their major properties

6. Systems with recoverable elements and systems with time-dependent failure rates

7. Markov models and behaviour of complex systems

8. Safety regulations of medical devices production, classification and structure of medical devices, design process

9. Modern electronic elements, properties, selection and application rules

10. Electromagnetic compatibility of medical devices

11. Power supplies, grounding, shielding, methods of interference rejection, methods of interconnection

12. Types, properties and applications of wires, cables and connectors

13. Design and development of elementary electronic functional blocks of medical devices

14. Mechanical design, cooling, debugging and bootstrapping

Syllabus of tutorials:

1. The system reliability problem definition, illustrative examples

2. Introduction to mathematical statistics, basic terms and relations

3. Distribution law properties, physical background and examples

4. Analysis of system components and highly complex systems, composite reliability evaluation I.

5. Complex system reliability evaluation II and graph-based methods

6. Markov chains application in reliability evaluation

7. Systems with self-recovering components, examples

8. Detector of QRS complex - design, simplified realization, verification of function

9. Possibility of galvanic separation used within the medical devices, verification of function

10. Common mode rejection - measurement of CMRR of biopotenctial amplifiers (model of amplifier)

11. Common mode rejection - measurement of CMRR of biopotenctial amplifiers (commercial amplifier)

12. Biopotential amplifier - measurement of elementary properties (model of amplifier)

13. Biopotential amplifier - measurement of elementary properties (commercial amplifier)

14. Summary of fundamental and important conclusions from the above mentioned measurements, credit

Study Objective:

Study materials:

1. DeVor, R.E. Statistical Quality Design and Control (Contemporary Concepts and Methods), McMillan Publ.. 1992

2. Kolarik, W.J. Creating Quality (Concepts, Systems, Strategies, and Tools). McGraw-Hill Publ.. 1995

3. Fries, R.C. Reliable Design of Medical Devices. New York: Marcel Dekker, Inc.. 1997

4. Kimmel, W.D., Gerke, D.D. Electromagnetic Compatibility in Medical Equipment. Piscataway: IEEE Press. 1995

Note:

Further information:

No time-table has been prepared for this course

The course is a part of the following study plans: