Adobe Systems Department of Biophysics, Medical Faculty, Masaryk University in Brno 1 Lectures on Medical Biophysics Medical Devices: Introduction Adobe Systems 2 Medical Biophysics ØIn Medical biophysics we will be dealing with the physical principles of biomedical methods and devices and their interactions with the human body - which makes them useful in health care, including patient and user safety aspects and healthcare quality issues. ØThe physical processes in living organisms and the effects of physical factors on them are important as background information. Adobe Systems 3 Links ØNatural sciences (physics, chemistry and biochemistry, biology) ØMorphological disciplines ØPhysiology and pathological physiology ØClinical disciplines (almost all!) Adobe Systems 4 Recommended textbook scipta This textbook and all the presentations shown in the lectures provide the information necessary to be successful in the exam!!! 5 How 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 sufficient to have a success at the exam. sisyf_anim Do not use the unauthorised texts! Adobe Systems 6 Medical Devices : Introduction Adobe Systems 7 What is a Medical Device? According to EU directives: “any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its 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 modification 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)) Adobe Systems 8 HealthCare Activities ØPrevention ØDiagnosis ØCurative (therapeutic) ØRehabilitation ØPalliative care (when cure is not possible) Adobe Systems 9 Medical Imaging Devices (in vivo diagnosis) ØX-ray projection imaging ØComputerised Tomography (CT) ØUltrasound (USI), Doppler imaging ØMagnetic resonance imaging (MRI) ØRadionuclide imaging (nuclear medicine) ØThermography ØEtc. ultrasound ultrasound Adobe Systems 10 Theoretical 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) Adobe Systems 11 Medical Laboratory Devices (in vitro diagnosis) Øsample separation, centrifugation etc Øelectrophoresis, capillary electrophoresis ØpH / ISE meters Øparticle / cell counters Øspectrophotometers Øflow cytometry Ømicroscopy ØHPLC (chromatography) Øclinical chemistry Øhaematology Øimmunology Øscintillation systems Øgenetic analysis Ø…………. Cover3 Adobe Systems 12 Theoretical 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 vitro diagnosis) Adobe Systems 13 Physiological Measurement Devices (in vivo diagnosis) ØInstruments for measuring physical and chemical variables in vivo ØThermometers ØCardiovascular physiology: blood pressure monitors, flowmeters, pulsed Doppler US systems ØElectrophysiology: ECG, EEG, EMG ØAudiology and ophthalmology ØRespiratory physiology: spirometers, pulse oximetry, impedance pneumograph…. ØEndoscopes Adobe Systems 14 Physiological Measurement Devices (in vivo diagnosis) Theoretical background: Introduction to thermodynamics, basic laws of hydrodynamics, origin of bioelectric potentials, properties of sound and light, ear and hearing, eye and vision, mechanical properties of living matter… Adobe Systems 15 spirometer [USEMAP] ECG (aka EKG) [USEMAP] sphygmomanometer Screen of a multipurpose clinical monitor Adobe Systems 16 Paediatric Intensive Care paed inten care unit Adobe Systems 17 Endoscopy schlinge 18 Radiotherapy Devices ØX-ray and electron, resp. hadron beams from accelerators (shape, direction, and intensity of beam changed often continuously) Øgamma-ray beams from tele-isotope radioactive sources like Co-60 Øtreatment planning systems Øsimulators Øbrachytherapy Ødosimeters Linear accelerator Patient prepared for Leksell gamma knife treatment Adobe Systems 19 Radiotherapy Devices Theoretical background: Ionising radiation (origin, measurement, interactions with matter), properties of atom nucleus, radioactivity, biological effects of ionising radiation, dosimetry…. ̶ 20 Physical therapy Devices ØElectrotherapy ØUV and IR therapy ØShortwave diathermy ØUltrasound therapy ØLaser therapy Ø….. Muscle stimulator Laser therapy unit Ultrasound therapy unit Shortwave diathermy Adobe Systems 21 Physiotherapy Devices Theoretical background Biological interactions of ultrasound, electromagnetic fields, electric current, infrared, visible and ultraviolet light, laser principle…. Adobe Systems 22 POC (Point of Care) Devices ØAddress clinicians’ requirements for rapid access to information to support critical care decisions ØAdvances in microelectronics and biosensor tools have brought technology to the bedside in a miniaturized form. ØExamples: ̶Performing blood tests at the patient's side rather than in a central laboratory ̶portable ultrasound imaging devices [USEMAP] 23 Surgical Theatre Devices, Lithotripsy Operating lamps anaesthesia electrocautery cryosurgery Adobe Systems 24 Surgical Theatre Devices, Lithotripsy Theoretical background Biological interactions of ultrasound, electromagnetic fields, electric current, infrared, visible and ultraviolet light, laser principle, low temperatures, acoustic shock waves… 25 Prosthetic Devices - Implants cortical-screw-4 prosthetics dr2 multiple-posterior-graphic Robotic device for acetabular cup implantation Výsledek obrázku pro knee surgery robot 26 Prosthetic Devices – „Artificial Organs“ artificial-heart-abiocor-hand 6 Retinal Implant ear implant diagram Artificial heart Cochlear implant Retinal implant Pulmonary Ventilator Cardiopul-monary bypass Český dodavatel tepelných výměníků rozšířil výrobu o plicní ventilátory | Hospodářské noviny (iHNed.cz) 27 Prosthetic 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 heated to body temperature. http://www.google.cz/url?source=imglanding&ct=img&q=http://bjr.birjournals.org/content/vol74/issue8 86/images/large/BI75492.5.6.jpeg&sa=X&ei=2WAvUOjVCZHKtAaOuYDQCw&ved=0CAsQ8wc&usg=AFQjCNGGRxkKk6j7ya xOCRy4pwIsnlFoUg http://www.google.cz/url?source=imglanding&ct=img&q=http://www.unifarma.com.ar/productos/ella_SX%20 Ella%20Stent_imag2.jpg&sa=X&ei=l2EvUNrqGcnftAa1_oDQDQ&ved=0CAsQ8wc&usg=AFQjCNFZl71uluAHnZCWSzOL6VnD 5c3CVg http://www.google.cz/url?source=imglanding&ct=img&q=http://www.drmcdougall.com/misc/2006nl/sept/ste nt.jpg&sa=X&ei=EGIvUPzjFczWsgbVloHIBQ&ved=0CAwQ8wc4SA&usg=AFQjCNG8GnDvunPsP4f5t-FcBVFlHQwE-A Adobe Systems 28 Devices for Self-testing (‘home devices’) Ø'device for self-testing`: any device intended by the manufacturer to be able to be used by lay persons in a home environment Øthermometers, pressure measuring instruments etc. Øtest kits (pregnancy, glucose levels in blood used by diabetes patients etc) Blood glucose meter Adobe Systems 29 Devices for Performance Evaluation of Devices 'device for performance evaluation`: devices to check the performance of medical devices are also considered as medical devices low Testing contrast resolution in XRI Adobe Systems 30 What is the Purpose of this Course? ØCreate awareness that medical devices should be used effectively and safely (reduce patient, occupational and others’ risk to a minimum) ØUse medical devices in a professional and scientific manner ØAppreciate uses of medical devices in the clinical areas and in research ØHave an idea of the devices used in other professions Adobe Systems 31 Some Competences for Users of Medical Devices What is expected the doctor does with or knows about the device? ØState the specific diagnostic, therapeutic etc outcomes expected when using the device ØExplain the physics principles underpinning the functioning of the device and the device use protocols ØDescribe the structure of commercially available devices including user option settings and controls ØIdentify possible health hazards (e.g. mechanical, electrical, radiation etc) to patient, self and colleagues ØDescribe measurable objective device performance indicators which are directly related to device effectiveness or safety Adobe Systems 32 Cont ... ØDemonstrates a level of capability in the use of the device that ensures the required level of effectiveness whilst minimising risk to patient, self and others ØExplains limitations of the device and contraindications for use ØDescribes the impact on effectiveness and risk arising from device malfunction or inappropriate user protocol ØDemonstrates timely device malfunction recognition and local procedures for reporting such faults ØDemonstrates skill in preventive maintenance and quality control including calibration of the device appropriate for users ØDemonstrates an awareness that a device should be checked before use and in the case of re-usable devices left in a condition for subsequent use ØDemonstrates adherence to International, European, National and local legislation and/or regulations regarding the use of the device Adobe Systems sisyf_anim Last revision September 2021, soundtrack added 2020: Authors: Carmel J. Caruana, Vojtěch Mornstein Language revision: Carmel J. Caruana