450-4042/02 – Reliabilty and Construction of Medical Apparatus (SKLP)
| Gurantor department | Department of Cybernetics and Biomedical Engineering | Credits | 4 |
| Subject guarantor | prof. Ing. Marek Penhaker, Ph.D. | Subject version guarantor | prof. Ing. Marek Penhaker, Ph.D. |
| Study level | undergraduate or graduate | | |
| | Study language | English |
| Year of introduction | 2015/2016 | Year of cancellation | |
| Intended for the faculties | FEI | Intended for study types | Follow-up Master |
Subject aims expressed by acquired skills and competences
Student will understand the design issues of medical devices in terms of reliability, biological compatibility, and the specific requirements of the use of devices in current medical practice. He will be able to assess what impacts the choice of construction materials, proper construction and other requirements such as cooling. Student will be able to demonstrate application of these requirements and properties on typical medical devices.
Teaching methods
Lectures
Tutorials
Summary
Application of physical principles to biological systems, interaction, sensitivity, specificity. Diagnosis, therapy. Legal requirements, hygiene levels and ecology. Certification of manufacturer and product. Risk Analysis. Standardisation, verification, clinical test.
Compulsory literature:
Norma IEC 601-1:1988 Medical electrical equipment. Part 1: General requirements for safety (Zdravotnické elektrické přístroje. Část 1: Všeobecné požadavky na bezpečnost
Recommended literature:
Norma IEC 601-1:1988 Medical electrical equipment. Part 1: General requirements for safety (Zdravotnické elektrické přístroje. Část 1: Všeobecné požadavky na bezpečnost
Additional study materials
Way of continuous check of knowledge in the course of semester
Tests and consultations during the exercises and tutorials
E-learning
Other requirements
There are not defined other requirements for students.
Prerequisities
Subject has no prerequisities.
Co-requisities
Subject has no co-requisities.
Subject syllabus:
Content of lectures
1. Medical reliability (alarm priority), hardware reliability (degradation resistance), software reliability (robustness of algorithms, quantification of expertise). Accreditation, registration, preconditioning, validation, certification, vigilance, disinfection.
2. Technical and biological systems, biophysics, neurotransmission, homeostasis
3. Bio-oscillograms, cardiogram, Poincaré phologram, hardware subsystems
4. Materials, structure. Strength. Electrical conductivity. Ferromaterials
5. Design criteria. Cooling. Electrothermal analogy.
6. Biomonitor function, rheography, hemodynamics, nomogram
7. Transformers, cardiograph, cardiotocograph, pacemaker, defibrillator, alarm indication.
8. Hematology, sonograph, cryocautery, electroscalpel, lithotriptor, X-ray, NMR, PET
Whiteboard exercises
1. Quantities, units, dimensional analysis
2. Approximation of nonlinearities, Saving amplifier (electronic Ranvier), superposition, series of values
3. Piezoresistance, pressure measurement, ultraacoustics, doppler
4. Acoustic alarm, normalization
5. Bioamplifier, voltage tendency detector, Bioohmmeter, biorhythmicity detector
6. Bioadmittance, defibrillator, Radio communication (telemeter)
7. Drip infusion, solution dosing, electrometer, electrodynamics
8. Lithotriptor, X-ray, transparency, gas analyser
Conditions for subject completion
Occurrence in study plans
Occurrence in special blocks
Assessment of instruction