450-4059/01 – Metrology and Calibration of Medical Devices (MKLEP)
| Gurantor department | Department of Cybernetics and Biomedical Engineering | Credits | 3 |
| Subject guarantor | prof. Ing. Martin Černý, Ph.D. | Subject version guarantor | prof. Ing. Martin Černý, Ph.D. |
| Study level | undergraduate or graduate | Requirement | Compulsory |
| Year | 2 | Semester | winter |
| | Study language | Czech |
| Year of introduction | 2013/2014 | Year of cancellation | |
| Intended for the faculties | FEI | Intended for study types | Follow-up Master |
Subject aims expressed by acquired skills and competences
Students are able to explain and apply the requirements and methods of metrological calibration of medical electronic devices. They will apply the methods of calibration procedures and diagnostic and therapeutic medical devices, will know the requirements for the operation of these devices in operation of hospitals, which are given by law and regulations. They will be able to analyze the structure and function of calibration tools and apply them in practice. They will be able to carry out regular safety technical inspection (BTK) and define the quality requirements of medical devices, not only in terms of legislative requirements, but also in practice. In practical exercises, students will work with the calibration and test equipment, to detect and verify their functionality and design and implement BTK.
Teaching methods
Lectures
Individual consultations
Experimental work in labs
Summary
The course deals with the metrology and testing of medical electrical equipment. On this area there are placed high requirements, defined at both national and international level. Students will be familiar with the regulations and metrological procedures with a focus on the specialised area of medical instrumentation. The major part of the course, however, consists of familiarization with the test equipment,its design, test procedures, and its projection to the common practice of the service technicians, the technicians in the hospital facilities but also the manufacturers and suppliers of medical technology.
Compulsory literature:
[1] Vejrosta, V.: Construction of medical electrical equipment - Application of the requirements of international and European standards. Prague, Czech Society for Medical Technology 2001
[2] EN 60359 "Electrical and electronic measuring equipment - expression properties"; CSNI 2003
Recommended literature:
[1] Guide to the Expression of Uncertainty of Measurements, ISO, Ženeva, 1993
[2] IEC 60359:2001; „Electrical and electronic measurement equipment - Expression of performance“
[3] Fabian, V., Dobias, M. Usage of technical standards in health care - experience an authorized metrological center, small producers and suppliers of medical equipment. Prague: CTU FBMI, 2007.
Additional study materials
Way of continuous check of knowledge in the course of semester
The credit is granted for submission of 6 protocols for laboratory tasks. The test is compulsory written and optional part of the oral. For the granting of credit is required mandatory participation in seminars at least 80% from the past lessons.
E-learning
Other requirements
Other requrements are not defined.
Prerequisities
Co-requisities
Subject has no co-requisities.
Subject syllabus:
In the lectures, students will be familiar with the following topics:
1 Legislation for the calibration of medical equipment in the Czech Republic and the EU
2 Metrology applications in biomedical engineering
3 El. Safety in medical operations and medical equipment, regular safety engineering controls.
4 Testing and calibration of medical instrumentation, rules, equipment, constructions testers - diagnostic equipment - ECG, EEG, EMG
5 Testing and calibration of medical instrumentation, rules, equipment, constructions testers - Diagnostic Instruments - NIBP, temperature
6 Testing and calibration of medical instrumentation, rules, equipment, constructions testers - Diagnostic Instruments - SpO2 and Lasers
7 Testing and calibration of medical instrumentation, rules, equipment, constructions testers - therapeutic devices - pacemakers
8 Testing and calibration of medical instrumentation, rules, equipment, constructions testers - therapeutic devices - defibrillators and electrocoagulation
9 Testing and calibration of medical instrumentation, rules, equipment, constructions testers - Therapeutic Devices - Infusion Technology
10 Testing and calibration of medical instrumentation, rules, equipment, constructions testers - ultrasonic diagnostic and therapeutic devices
11 Testing and calibration of medical instrumentation, rules, equipment, constructions testers - ultraterapeutické equipment - generators medicinal currents,
12 Testing and calibration of medical instrumentation, rules, equipment, constructions testers - Imaging systems - X-ray, CT
13 Testing and calibration of medical instrumentation, rules, equipment, constructions testers - Imaging systems - NMR
14 final test
Stretch the exercises in this course are practical laboratory exercises using modern test technology, which is owned by the university:
1 Processing BTK
2 Universal tester diagnostic medical devices and SpO2
3 Universal tester medical diagnostic equipment, defibrillators and pacemakers
4 Tester noninvasive and invasive blood pressure monitors, simulator invasive measurement of blood Talk
5 Calibration of thermometers and testers electrocoagulation devices
6 Testers infusion techniques
7 Testers and phantoms for imaging, ultrasound
Conditions for subject completion
Occurrence in study plans
Occurrence in special blocks
Assessment of instruction