450-4059/01 – Metrology and Calibration of Medical Devices (MKLEP)

Gurantor departmentDepartment of Cybernetics and Biomedical EngineeringCredits3
Subject guarantordoc. Ing. Martin Černý, Ph.D.Subject version guarantordoc. Ing. Martin Černý, Ph.D.
Study levelundergraduate or graduateRequirementCompulsory
Year2Semesterwinter
Study languageCzech
Year of introduction2013/2014Year of cancellation
Intended for the facultiesFEIIntended for study typesFollow-up Master
Instruction secured by
LoginNameTuitorTeacher giving lectures
CER275 doc. Ing. Martin Černý, Ph.D.
KLI02 Ing. Tomáš Klinkovský
Extent of instruction for forms of study
Form of studyWay of compl.Extent
Full-time Credit and Examination 2+1
Combined Credit and Examination 2+12

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.

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

Další požadavky na studenta

Other requrements are not defined.

Prerequisities

Subject codeAbbreviationTitleRequirement
450-4008 LDP Diagnostic Instruments in Medicine Recommended

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

Full-time form (validity from: 2013/2014 Winter semester)
Task nameType of taskMax. number of points
(act. for subtasks)
Min. number of points
Exercises evaluation and Examination Credit and Examination 100 (100) 51
        Exercises evaluation Credit 44  21
        Examination Examination 56  30
Mandatory attendence parzicipation:

Show history

Occurrence in study plans

Academic yearProgrammeField of studySpec.FormStudy language Tut. centreYearWSType of duty
2019/2020 (N2649) Electrical Engineering (3901T009) Biomedical Engineering P Czech Ostrava 2 Compulsory study plan
2019/2020 (N2649) Electrical Engineering (3901T009) Biomedical Engineering K Czech Ostrava 2 Compulsory study plan
2019/2020 (N0788A060001) Biomedical Engineering P Czech Ostrava 2 Compulsory study plan
2019/2020 (N0788A060001) Biomedical Engineering K Czech Ostrava 2 Compulsory study plan
2018/2019 (N2649) Electrical Engineering (3901T009) Biomedical Engineering P Czech Ostrava 2 Compulsory study plan
2018/2019 (N2649) Electrical Engineering (3901T009) Biomedical Engineering K Czech Ostrava 2 Compulsory study plan
2017/2018 (N2649) Electrical Engineering (3901T009) Biomedical Engineering K Czech Ostrava 2 Compulsory study plan
2017/2018 (N2649) Electrical Engineering (3901T009) Biomedical Engineering P Czech Ostrava 2 Compulsory study plan
2016/2017 (N2649) Electrical Engineering (3901T009) Biomedical Engineering K Czech Ostrava 2 Compulsory study plan
2016/2017 (N2649) Electrical Engineering (3901T009) Biomedical Engineering P Czech Ostrava 2 Compulsory study plan
2015/2016 (N2649) Electrical Engineering (3901T009) Biomedical Engineering K Czech Ostrava 2 Compulsory study plan
2015/2016 (N2649) Electrical Engineering (3901T009) Biomedical Engineering P Czech Ostrava 2 Compulsory study plan
2014/2015 (N2649) Electrical Engineering (3901T009) Biomedical Engineering K Czech Ostrava 2 Compulsory study plan
2014/2015 (N2649) Electrical Engineering (3901T009) Biomedical Engineering P Czech Ostrava 2 Compulsory study plan
2013/2014 (N2649) Electrical Engineering (3901T009) Biomedical Engineering P Czech Ostrava 2 Compulsory study plan
2013/2014 (N2649) Electrical Engineering (3901T009) Biomedical Engineering K Czech Ostrava 2 Compulsory study plan

Occurrence in special blocks

Block nameAcademic yearForm of studyStudy language YearWSType of blockBlock owner