Documente Academic
Documente Profesional
Documente Cultură
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Required Text Books and References
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Introduction
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What is a Medical Instrument
A ‘Medical Instrument’ is 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 for
human beings for the purpose of:
¾ diagnosis, prevention, monitoring, treatment or
alleviation of disease,
¾ diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap,
¾ investigation, replacement or modification of the
anatomy or of a physiological process,
¾ 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
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Medical Instruments Classes
Class I: General Controls: devices present minimal
potential for harm to the user and are often simpler
in design than Class II or Class III devices such:
¾ tongue depressors, bedpans, elastic bandages,
examination gloves, and hand-held surgical instruments
and other similar types of common equipment, …..etc
Class II: General Controls with Special Controls :
are those for which general controls alone are
insufficient to assure safety and effectiveness.
They are typically non-invasive and include:
¾ x-ray machines, PACS, powered wheelchairs, infusion
pumps, surgical drapes, surgical needles and suture
material, and Acupuncture needles,………etc
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Medical Instruments Classes (cont.)
Class III: General Controls and Premarket
Approval : device is one for which insufficient
information exists to assure safety and
effectiveness solely through the general or special
controls sufficient for Class I or Class II devices.
Such a device needs premarket approval, a
scientific review to ensure the device's safety and
effectiveness. They are life-supporting or life-
sustaining devices such:
¾ replacement heart valves, silicone gel-filled breast
implants, implanted cerebral stimulators, Ventilators,
bed side monitors, ….etc
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1. X-Ray Systems
1-1. Fundamentals of X-Ray
¾ Production of X-Rays
¾ Properties of X-Rays
¾ Units of X-Radiation
1-2. X-Ray Machine
¾ X-Ray Generator:
9 High Voltage generation
9 High frequency generation
9 Automatic Exposure Control
¾ X-Ray tube
¾ High tension cable
¾ Collimators and Grids
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1. X-Ray Systems (Cont.)
1-3. Visualization of X-Rays
¾ X-Ray Films
¾ Fluorescent Screens
¾ X-Ray Image Intensifier Television System
1-4. Examination Table
1-5. Kinds of X-Ray Machines
¾ Mobile Unit
¾ Dental Unit
¾ Mammography Unit
1-6. Digital Radiography
¾ Overview
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1-1. Fundamentals of X-Ray
Production of X-Rays:
¾ X-rays (or Röntgen rays) are a form of electromagnetic
radiation with a wavelength in the range of 0.01 to 10
nanometers, corresponding to frequencies in the range
30 to 30 000 PHz (1 PHz = 1015 Hertz)
¾ X-rays are produced whenever electrons collide at very
high speed with matter and are thus stopped
¾ The energy possessed by the electrons appears after
collision in two forms:
99 % Heat
1 % X-rays
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1-1. Fundamentals of X-Ray (con.)
Properties of X-Rays
¾Short wavelength
¾Extremely high energy
¾Able to penetrate through materials
¾Absorbed when passing through matter
¾Extent of absorption depends upon the density
of matter
¾Produce secondary radiation in all matter
through which they pass
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1-1. Fundamentals of X-Ray (con.)
Units of X-Radiation
¾ The measure of the quantity of x-radiation is “Rontgen” (R)
¾ Rontgen is the ability of radiation to produce ionization
¾ One (R) is the amount of x-radiation which will produce
2.08x109 ion pairs per cubic centimeters of air at standard
temperature (0oC) and pressure (760 mmHg) at sea level.
¾ The curie (Ci) is the old standard unit for measuring the
activity of a given radioactive sample.
¾ The Becquerel’s is the more recent SI unit for radioactive
source activity (1 curie = 3.7 x 1010 Becquerel's)
¾ Rad: Measurement unit of absorbed dose ( SI: Gray)
¾ rem: Measurement unit of the relative biological damage as
results from the absorbed dose (SI: sieverts (Sv) )
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1-1. Fundamentals of X-Ray (con.)
Units of X-Radiation (cont.)
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1-2. X-Ray Machine
Generate high-energy, high frequency electromagnetic
waves (X-Rays) for use in diagnostic and treating disease
Block diagram of an x-ray machine
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X-Ray Generation
X-Ray Generator
¾ High voltage generator:
modifies incoming voltage and
current to provide an x-ray
tube with the power needed to
produce an x-ray beam of the
desired peak kilovoltage (kVp)
and current (mA) and duration
(Time).
¾ Major components are:
9 Control panel
9 Transformer assembly
X-ray generator components
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X-Ray Generation
Control panel
¾ Permits the selection of
technique factors and
initiation of radiographic
exposures
9 mA, kV, Time
Transformer assembly:
¾ Transformer
¾ Rectifiers
¾ Three major circuits:
9 High voltage circuit
9 The filament circuit
9 Timer circuit 15
X-Ray Generation
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X-Ray Generation
¾ 3-phase, 6 pulses
¾ 3-phase, 12 pulses
¾ High frequency
¾ Constant potential
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X-Ray Generation
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