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The discipline "Modern medical equipment (Medical Devices)"

1. Introduction (the lecture 1, S.N. Britin)

The classification of medical equipmentis a main way to understand an


engineering knowledge of medicine environment. Electronic medical equipment:
medical devices, systems and complexes are the most important chain in modern
diagnostic and medical technologies. All electronic medical equipment may be
combined into several groups. Perceiving and acting medical equipment.
Electromagnetic radiation, frequency ranges, wavelengths, medical applications.
Generalized structural schemes, elements and characteristics of equipment for
diagnosis and therapy. Features of analog and digital devices and systems.
Fundamentals of the safe operation of medical equipment. The role of
measurement in medicine. Metrological support of medical equipment.

Great progress in the development of medical technology and medical electronics,


especially over the past 50 years, has basically contributed to the transformation of
medicine from art to exact science.

All medical equipment includes medical instruments, medical apparatuses, medical


devices, systems, complexes and auxiliary equipment.

Auxiliary medical equipment includes medical beds, various chairs, cabinets,


infusion pumps, etc.

Medical instruments are the technical means by which prophylactic, diagnostic,


therapeutic, research procedures are performed on the patient’s organs and tissues.
Instruments are held in the hand and are driven by human muscle power, or they
are a replaceable part of a medical machine.

Medical apparatuses are technical means for physiotherapy that generate some
kind of energy with the aim of influencing the body, for example, heat, light,
electricity, etc. They also include technical devices that replace individual
functions of the body for a certain time.

Medical devices are technical means for measuring and evaluating the
physiological parameters of an organism. Their main task is to diagnose the
condition of the patient. Medical devices, as well as systems and complexes allow
us to automate the diagnostic and treatment process and significantly improve its
quality. Medical apparatuses are often also called medical devices.

The interaction between the medical device and the patient is carried out with the
help of one or another energy: mechanical, thermal, chemical, electrical, magnetic.
Electrical and magnetic energy is a special case of electromagnetic radiation
energy and plays a fundamental role in the life of organisms. Most modern medical
devices and systems refer to electronic devices and the name "Medical Electronics"
is applied to them.
Electromagnetic radiation (EM radiation or EMP) refers to waves (or their
quanta, photons) of an electromagnetic field propagating (radiating) through space,
carrying the energy of electromagnetic radiation. Classically, electromagnetic
radiation consists of electromagnetic waves, which are synchronized oscillations of
the electric and magnetic fields. In a vacuum, electromagnetic waves propagate at
the speed of light, usually denoted by C. Typically, this speed is assumed to be
300,000 km / s.
The electromagnetic radiation scale is shown in Fig. 1
https://en.wikipedia.org/wiki/Electromagnetic_radiation

Figure 1 Scale and names of ranges of electromagnetic radiation

In homogeneous isotropic media, the oscillations of two fields are


perpendicular to each other and perpendicular to the direction of propagation of
energy and wave, forming a transverse wave. The wavefront of electromagnetic
waves emitted by a point source is a sphere. The position of the electromagnetic
wave in the electromagnetic spectrum can be characterized either by the oscillation
frequency (denoted by f or ν), or by the wavelength λ. Electromagnetic waves of
different frequencies are called differently because they have different sources and
effects on matter, including the body. In order of increasing frequency and
decreasing wavelength, these are: radio waves, microwaves, infrared radiation,
visible light, ultraviolet radiation, x-ray radiation and gamma radiation. The basis
of many processes is periodic harmonic (sinusoidal) oscillations (Fig. 2). The
frequency of such an oscillation is f = 1 / T.

Figure 2 Harmonic (sinusoidal) oscillation

The EMP wavelength is λ = CT or λ = C / f. (The wavelength is the distance


over which the wave propagates in a time equal to one period). An important
parameter of the EMP is the photon (quantum) energy E = hf or E = hν, where h is
the Planck constant. Ultraviolet radiation, x-rays and gamma radiation have
ionizing properties due to the high energy of the quanta. In the range of radio
waves, the depth of penetration into water is comparable with the wavelength.
EMR of all ranges are widely used in medical practice for diagnosis and
physiotherapy, as well as in the most diverse fields of science and human activity.
An example of the application of x-ray radiation is shown in Fig. 3.
Figure 3 X-ray application

The formation of fractional and multiple units is presented in table 1.

Table 1

Prefix
Multiplier Designation
Nameofprefix
Russian International
-18
10 atto а a
10-15 femto ф f
10-12 pico п p
10-9 nano н n
10-6 micro мк 
10-3 milli м m
10-2 santi с c
10-1 dec д d
101 deka да da
102 hecto г h
103 kilo к k
106 mega М M
109 giga Г G
1012 tera Т T
1015 peta П P
1018 exa Э E
Modern medical equipment is an all-band radio-electronic, laser and cryogenic
equipment, tomographic scanners, radiological and acoustic devices, artificial
“organs”, complex of life-support systems, technical means based on the
achievements of quantum physics, micro and nanotechnology,polymer
chemistry,the technique of high energies, short-lived isotopes, etc.
Anew page is opened by the capabilities of digital computing technology,
microprocessors, technical means for the synthesis of volumetric images of
internal organs, the capabilities of systems on a chip, the capabilities of artificial
intelligence systems and robotics.

The General structure of the medical device is shown in Fig.4.

 1 – generator;
 2 – transducer ore lectrodes;
 3 – measuring transducer (sensor) or electrodes;
 4 – electric voltage amplifier;
 5 – analog registration device;;
 6 – analog-to-digital converter (ADC);
 7 – computer or digital signal transmission, reception and processing
system.

Figure 4. Generalized block circuit of a medical device (system)

According to Fig.4the Generator1 generates impulsesor continuous vibrations,


which are fed to the patient through the Transducer 2. Electrodes are
usedto influence the patient with an electric current. Thatcan be made of
metal plates or needles. To influence the patient EMI Transducer is
performed in the form of a special antenna or inductor. In some cases, the
Transducer is not required, for example, when the patient is exposed to x-
rays. In the case of exposure to mechanical ultrasonic vibrations on the
patient, piezo-electric transducers are often used.
The left part of the structure (Blocks 1, 2) provides an idea of building a
simple device for physiotherapy or stimulation.
Now consider the right side of the diagram (Blocks 3-7). The most important
node of this part is the primary measuring Transducer (sensor) 3. The
function of the Transducer 3 is to sense often weak physiological
indicators and linearly display them as an output electrical voltage. If the
physiological parameters are electrical values, then electrodes are used as
converters. As a rule, in practice, electrodes made of non-polarizable
materials are used. After the Converter, the signals are amplified (Block
4), for example, 1000 times in the electrocardiograph, and then can be
registered by block 5. Together, blocks 3,4, 5 represent an analog
receiving device for measuring a number of physiological quantities.
Modern devices are usually digital devices that have a number of
advantages over analog means.
In a digital device, the signal after the amplifier (Block 4) goes to the
Analog-to-digital converter (ADC) 6, where it is sampled in time and
quantized by level, which makes it possible to represent it as readouts in
the form of binary numbers. These processes are explained in figures 5
and 6. Figure 5 shows the time sampling of the signal. Here the signal
samples are taken through the interval T, which is called the sampling
interval, and selected according to the Kotelnikov - Nyquist theorem from
the ratio T≤1/2fv, (fv is the upper bound frequency of the signal
spectrum). If, for example, in electrocardiography, we take fv = 100 Hz,
then T≤50 ms. For Fig.6 shows quantization of the signal by level. This
means that the continuous values of the samples are replaced by discrete
ones and are eventually represented as numeral- a digital signal. Figure 6
shows that the first count here is 4 or in binary code 100, the second
count is 5 or 101, and so on. Note that the higher the ADC bit rate, the
higher its accuracy. Block 7 in the structure of the device is a digital
computing device (microprocessor, computer) or a digital system for
transmitting, receiving and processing signals.
Signal sampling representation. The continuous signal is represented with a green
colored line while the discrete samples are indicated by the blue vertical lines

Figure 5 Sampling the signal over time

In signal processing, a digital signal is an abstraction that is discrete in time and


amplitude, meaning it only exists at certain time instants.

Figure 6 Quantization of a signal by level - receiving a digital signal


In many cases, information about the patient's condition can only be
obtained if the patient is affected by any stimuli (electrical impulses,
sound, light....) or radiation (x-ray, ultrasound, etc.). Then the structure of
the medical device will fully correspond to the scheme with blocks 1, 2,
3, 4, 5 (analog device) or a circuit with blocks 1, 2, 3, 4, 6, 7 ( digital
device). In the second case, block 1 is usually implemented taking into
account the capabilities of digital technology. To improve the quality of
the device, can be enabled a feedback between the blocks (not shown in
the figure).
Actual device structures can be more complex. Devices can be combined
into systems and simultaneously evaluate a variety of physiological
indicators of the body, can be combined into complexes with systems for
maintaining human life in critical situations. Devices for laboratory
medical diagnostics have their own distinctive features.
To effectively use a medical device, you need to know its technical
characteristics.
Let's look at the most important characteristics of devices.
The range of the device. For a diagnostic device, this is the complete set
or range of values of the measured values for which the device is
designed in normal operation. For a therapeutic device, this is a range of
values, such as current, voltage, power, and intensity at the output of the
device.
Operating frequency or range of operating frequencies. An important indicator
for all types of devices. It is expressed in Hertz(Hz, kHz, MHz, GHz). In
the area of very high frequencies, EMI uses a wavelength instead of a
frequency.
Sensitivity. The most important characteristic for diagnostic devices.
Sensitivity is expressed by the ratio of the change in the output value to
the change in the input value of the device. For example, when registering
an electrocardiogram, a change in the input signal by 1 mV may
correspond to a change in the recording of 10 mm (Sensitivity of 10
mm/mV). Along with sensitivity, the sensitivity threshold parameter is
used, which determines the minimum value of the measured value, for
example, 10 mV.
Resolution. Shows the minimum distance between two objects that can be
distinguished separately. Resolution determines the quality of
visualization systems and affects accuracy.
The accuracy of the device is its ability to accurately indicate the true (actual)
value of the measured indicator or accurately set the value of the value at
the output of the device for therapy. Very often, accuracy is expressed by
the maximum allowable error (error). The error is determined by the
deviation of the value indicated by the device from the true value.
According to this characteristic, all medical devices, systems and
complexes are referred to as measuring instruments. To maintain the
specified accuracy, they are necessarily subjected to metrological control:
periodic verification or calibration using exemplary measuring
instruments. Many devices have built-in calibrators to reduce possible
gross errors. An example of such a calibrator is a 1 mV pulse voltage
source in an electrocardiograph. The recording of this pulse is present on
all electrocardiograms.
The device's noise immunity shows the ability to work in conditions of
interference from various sources. One of the characteristic disturbances
is caused by pointing the device at the electrical voltage from the 220 V
supply network with a frequency of 50 Hz. To reduce the impact of such
interference, special filters, including digital filters, are built into the
devices during design. Other types of interference that must be
considered when operating the device are artifacts caused by the patient's
movements, EMI radiation from external systems and internal noise from
electronic components. The device itself also requires minimal radiation
to the surrounding space.
Other important characteristics of the devices include ease of use by
medical personnel and convenience for the patient. For the safety of
medical personnel and patients, many factors must be taken into account:
the risk of electric shock to the patient, the risk of EMI, in particular, x-
rays, etc.
The task
Study the lecture and the article presented in the lecture 1. Write briefly in
workbooks: Major achievements in medical devices and medical electronics for
100 years. Add these notes to your work (Library-research paper).

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