MedicalDeviceScienceIntroduction医疗设备科学导论学习课程

1、1Medical Devices: IntroductionLectures on Medical BiophysicsDepartment of Biophysics, Medical Faculty, Masaryk University in Brno第1页/共38页第一页，编辑于星期六：七点 三十二分。2Medical BiophysicsIn Medical biophysics we will be dealing with the physical principles of biomedical methods and devices and their interaction

2、s with the human body - which makes them useful in health care, including patient and user safety aspects and healthcare quality issues. The physical processes in living organisms and the effects of physical factors on them are important as background information.第2页/共38页第二页，编辑于星期六：七点 三十二分。3Links Na

3、tural sciences (physics, chemistry and biochemistry, biology) Morphological disciplines Physiology and pathological physiology Clinical disciplines (almost all!)第3页/共38页第三页，编辑于星期六：七点 三十二分。4Recommended textbook This textbook and all the presentations shown in the lectures provide the information nece

4、ssary to be successful in the exam!第4页/共38页第四页，编辑于星期六：七点 三十二分。5How to study?Studying medical biophysics, there is no problem with the amount of knowledge which is necessary to master, but with understanding the physical principles and their application. Memorisation without understanding will not be

5、 sufficient to have a success at the exam. 第5页/共38页第五页，编辑于星期六：七点 三十二分。6Medical Devices : Introduction 第6页/共38页第六页，编辑于星期六：七点 三十二分。7What is a Medical Device?“any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its

6、proper application intended by the manufacturer to be used on human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, or alleviation of or compensation for an injury or handicap, investigation, replacement or modifica

7、tion of the anatomy or of a physiological process, control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.” (MDD Article 1(2a)第7页/共38页第七页，编辑于星

8、期六：七点 三十二分。8The EU Medical Device DirectivesThe Medical Devices Directive (MDD) (93/42/EEC, OJ L169 p0001-0043) : from bandages, tongue depressors, thermometers to contact lenses, stethoscopes, splints, first-aid kits, breathalysers, heart valves and imaging equipmentThe In-Vitro Diagnostic Medical

9、Devices Directive (IVDD) (98/79/EC OJ L331 p0001-0037): reagents, control standards, test-kits, equipment intended for the in-vitro examination of human specimens e.g. blood grouping reagents, pregnancy test kits, Hepatitis B test kitsThe Active Implantable Medical Devices Directive (AIMDD) (90/385/

10、EEC OJ L189 p0017-0036): active (i.e. include an energy source) implants or partial implants e.g. heart pacemakersMost countries have transposed these directives into a single national legislation (e.g. UK Medical Devices Regulations 2002)第8页/共38页第八页，编辑于星期六：七点 三十二分。9HealthCare Activities Prevention

11、Diagnosis Curative (therapeutic) Rehabilitation Palliative care (when cure is not possible)第9页/共38页第九页，编辑于星期六：七点 三十二分。10Medical Imaging Devices (in vivo diagnosis)X-ray projection imagingComputerised Tomography (CT)Ultrasound (USI), Doppler imagingMagnetic resonance imaging (MRI)Radionuclide imaging

12、 (nuclear medicine)ThermographyEtc.第10页/共38页第十页，编辑于星期六：七点 三十二分。11Theoretical background:Ionising radiation (origin, measurement, interactions with matter), properties of atoms and nucleus, radioactivity, basic terms of acoustics, electromagnetic spectrum. Medical Imaging Devices (in vivo diagnosis)第

13、11页/共38页第十一页，编辑于星期六：七点 三十二分。12Medical Laboratory Devices (in vitro diagnosis)sample separation, centrifugation etcelectrophoresis, capillary electrophoresis pH / ISE meters particle / cell countersspectrophotometers flow cytometry microscopy HPLC (chromatography)clinical chemistryhaematology immunol

14、ogyscintillation systems genetic analysis 第12页/共38页第十二页，编辑于星期六：七点 三十二分。13Theoretical background:Structure of biopolymers, properties of water and electrolytes, electric properties of living matter, galvanic cell, sedimentation of particles, dosimetry, light absorption Medical Laboratory Devices (in

15、vitro diagnosis)第13页/共38页第十三页，编辑于星期六：七点 三十二分。14Physiological Measurement Devices (in vivo diagnosis)Instruments for measuring physical and chemical variables in vivoThermometers Cardiovascular physiology: blood pressure monitors, flowmeters, pulsed Doppler US systemsElectrophysiology: ECG, EEG, EMGA

16、udiology and ophthalmologyRespiratory physiology: spirometers, pulse oximetry, impedance pneumograph.Endoscopes第14页/共38页第十四页，编辑于星期六：七点 三十二分。15Physiological Measurement Devices (in vivo diagnosis)Theoretical background:Introduction to thermodynamics, basic laws of hydrodynamics, origin of bioelectric

17、 potentials, properties of sound and light, ear and hearing, eye and vision, mechanical properties of living matter第15页/共38页第十五页，编辑于星期六：七点 三十二分。16ECG (aka EKG)sphygmomanometerScreen of a multipurpose clinical monitor第16页/共38页第十六页，编辑于星期六：七点 三十二分。17Paediatric Intensive Care第17页/共38页第十七页，编辑于星期六：七点 三十二分

18、。18Endoscopy第18页/共38页第十八页，编辑于星期六：七点 三十二分。19Radiotherapy DevicesX-ray and electron, resp. hadron beams from accelerators (shape, direction, and intensity of beam changed often continuously)gamma-ray beams from tele-isotope radioactive sources like Co-60treatment planning systems simulatorsbrachythera

19、pydosimetersLinear acceleratorLeksell gamma knife第19页/共38页第十九页，编辑于星期六：七点 三十二分。20Radiotherapy DevicesTheoretical background:Ionising radiation (origin, measurement, interactions with matter), properties of atom nucleus, radioactivity, biological effects of ionising radiation, dosimetry.第20页/共38页第二十页，

20、编辑于星期六：七点 三十二分。21Physical therapy DevicesElectrotherapyUV and IR therapyShortwave diathermyUltrasound therapyLaser therapyMuscle stimulatorLaser therapy unitUltrasound therapy unitShortwave diathermy第21页/共38页第二十一页，编辑于星期六：七点 三十二分。22Physiotherapy DevicesTheoretical backgroundBiological interactions of

21、 ultrasound, electromagnetic fields, electric current, infrared, visible and ultraviolet light, laser principle.第22页/共38页第二十二页，编辑于星期六：七点 三十二分。23POC (Point of Care) DevicesAddress clinicians requirements for rapid access to information to support critical care decisionsAdvances in microelectronics an

22、d biosensor tools have brought technology to the bedside in a miniaturized form. Examples: Performing blood tests at the patients side rather than in a central laboratory portable ultrasound imaging devices第23页/共38页第二十三页，编辑于星期六：七点 三十二分。24Surgical Theatre Devices, LithotripsyOperating lampsanaesthesi

23、aelectrocauterycryosurgery第24页/共38页第二十四页，编辑于星期六：七点 三十二分。25Surgical Theatre Devices, LithotripsyTheoretical backgroundBiological interactions of ultrasound, electromagnetic fields, electric current, infrared, visible and ultraviolet light, laser principle, low temperatures, acoustic shock waves第25页/共

24、38页第二十五页，编辑于星期六：七点 三十二分。26Surgical Theatre Devices第26页/共38页第二十六页，编辑于星期六：七点 三十二分。27Surgical Theatre Devices第27页/共38页第二十七页，编辑于星期六：七点 三十二分。28Prosthetic Devices - ImplantsRobotic device for knee prosthesis implantation第28页/共38页第二十八页，编辑于星期六：七点 三十二分。29Prosthetic Devices Artificial Organs“Artificial heartC

25、ochlear implantRetinal implantVentilatorCardiopul-monary bypass第29页/共38页第二十九页，编辑于星期六：七点 三十二分。30Prosthetic Devices Artificial Organs“ Stents are inserted into the damaged blood vessels, oesophagus etc. They are often made of a metal with a shape memory“ nitinol, which adopts the intended shape when h

26、eated to body temperature.第30页/共38页第三十页，编辑于星期六：七点 三十二分。31Disposable Medical DevicesSuction catheterUmbilical cord clampI.V. cannulae第31页/共38页第三十一页，编辑于星期六：七点 三十二分。32Devices for Self-testing (home devices)device for self-testing: any device intended by the manufacturer to be able to be used by lay per

27、sons in a home environmentthermometers, pressure measuring instruments etctest kits (pregnancy, glucose levels in blood used by diabetes patients etc)Blood glucose meter第32页/共38页第三十二页，编辑于星期六：七点 三十二分。33Devices for Performance Evaluation of Devicesdevice for performance evaluation: devices to check th

28、e performance of medical devices are also considered as medical devicesTesting contrast resolution in XRI第33页/共38页第三十三页，编辑于星期六：七点 三十二分。34What is the Purpose of this Course?Create awareness that medical devices should be used effectively and safely (reduce patient, occupational and others risk to a m

29、inimum)Use medical devices in a professional and scientific mannerAppreciate uses of medical devices in the clinical areas and in researchHave an idea of the devices used in other professions第34页/共38页第三十四页，编辑于星期六：七点 三十二分。35Some Competences for Users of Medical DevicesWhat is expected the doctor does

30、 with or knows about the deviceState the specific diagnostic, therapeutic etc outcomes expected when using the deviceExplain the physics principles underpinning the functioning of the device and the device use protocols Describe the structure of commercially available devices including user option s

31、ettings and controlsIdentify possible health hazards (e.g. mechanical, electrical, radiation etc) to patient, self and colleaguesDescribe measurable objective device performance indicators which are directly related to device effectiveness or safety第35页/共38页第三十五页，编辑于星期六：七点 三十二分。36Cont .Demonstrates a level of capability