Chapter 17

MEDICAL ELECTRONICS

17.1. TASKS OF MEDICAL ELECTRONICS.

CLASSIFICATION OF ELECTRONIC MEDICAL EQUIPMENT

Electronics is the branch of science and technology in which

operation and application of electric vacuum, ion, and semi-
conductor devices are considered. Medical electronics considers
the features of applying electronic systems for solving medical
and biological problems as well as the design of respective
equipment.
At present electronic devices are widely used in medicine. It
is possible to identify three key groups of tasks (and three groups
of devices respectively) which are solved with the help of medical
equipment:
 receiving (pickup) medical and biological information;
 influence of various physical factors on a human organism
for therapeutic purposes;
 processing and storage of medical and biologic information.
According to these tasks, medical electronic equipment is
classified as follows:
 monitoring-diagnostic;
 therapeutic;
 cybernetic electronic devices.

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 Monitoring-diagnostic equipment is intended for pickup,
transfer and recording of information on processes occurring in a
human organism, in the environment, and in various medical
units. The block diagram of monitoring-diagnostic equipment is
shown in Fig. 17.1. The part of the diagram outlined by a dotted
line may be absent. Other elements of the diagram are required
for any monitoring-diagnostic device.

Pickup Measuring
Amplifier Transmitt Receiver
device (recording)
er
(sensor) device
Communication channel

Fig. 17.1. The block diagram of monitoring-diagnostic equipment

Therapeutic equipment is intended for dosed influence of

various physical factors on a human organism for therapeutic
purposes. The variety of different kinds of influences on a human
organism also determines the variety of circuit design of electronic
therapeutic devices (microwave therapy devices,
cardiostimulators, UHF therapy devices, etc.). For this class of
devices, a power supply, a generator and a monitoring instrument
for controlling the level of influence on the patient are obligatory.
Cybernetic electronic devices are intended for processing
and storage of medical and biologic information, for vital activity
control, for automatic control of environmental conditions, etc. As
a rule, computers are a component of such devices.

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 17.2. ELECTRICAL SAFETY OF ELECTRONIC MEDICAL
EQUIPMENT

One of the key issues related to use of electronic medical

equipment is its electrical safety, i.e. the chance of a harmful
(unforeseen) affect on patients or medical personnel. There are
two possible reasons for this:
 damage of the protective insulation resulting in direct contact
of a person with the current-carrying elements (most often
this is breakdown to the instrument case);
 existence of leakage currents. Presence of leakage current
is due to that even with the best insulation its conductivity is
never equal to zero (first of all due to capacitive coupling) and
the leakage current always exists, although it is small. In most
cases the leakage current can be neglected, but sometimes
(for example, during cardiac and cerebral operations) it
should be taken into account.
Medical equipment subdivides into the four following classes
with respect to allowable leakage current:
1. N is normal degree of protection, appropriate to a degree of
protection of household appliances (under normal conditions
the leakage current Il  0.25 mA).

2. В is increased degree of protection (Il  0.1 mA).

3. BF is increased degree of protection and presence in the
device of an isolated working part (Il  0.1 mA).

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 4. CF is the highest degree of protection and presence of an
isolated working part. In particular, equipment intended for
working in conditions of direct contact with the heart should
be of CF class (Il  0.01 mA).

Let us consider the basic methods of ensuring electric safety

during breakdown to the instrument case. Breakdown to the case
is seen as damage to the protective insulation of any parts of the
electronic device resulting in electric contact between these parts
and the case. Electric contact of the patient or the personnel with
the instrument case may result in electrical injury or even in the
death of the person.
Grounding of the device case is most common method for
protection against electrical shock at breakdown to the case. This
is effected by connecting the instrument case to the ground with a
small-resistance (no more than 4 Ohm) conductor. This leads to
redistribution of voltage in the current circuit from the case to the
neutral wire. Therefore, the voltage across the instrument case
and the ground (i.e. the voltage creating current through the
person contacting the device case) is small (about several volts)
and does not present any danger to the person.
Nevertheless, grounding cannot be seen as completely
ensuring protection against electrical shock. Should breakdown to
the case occur, the intensity of the current in a grounding
conductor would be about 200 mA. Such current may not cause
blowing of fuses that disconnect the device from the circuit.
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Therefore a device with damaged insulation may work rather long
before this damage will be revealed. If two devices having a
breakdown to the case operate concurrently, the voltage between
their cases may be about 220 V. In this case, a person touching
these two devices simultaneously will get an electric shock, so
grounding the cases of devices is ineffective.
Therefore, to ensure a higher degree of protection from
electric current shock, neutral earthing of the device case is used.
In other words, the case of the device is connected by a low-
resistance conductor to a neutral wire. At this, at breakdown to the
case the current flows from the case to the neutral wire through
this conductor with a resistance of a fraction of Ohm. This results
in such high currents that blow any fuse to disconnect the device
from the electric power supply.

17.3. RELIABILITY OF ELECTRONIC MEDICAL EQUIPMENT

The problem of reliability is crucial for medical equipment

since failure of devices or apparatus can injure the patient or even
result in his death.
Serviceability of equipment depends on many reasons.
Failure of equipment is a random event. Therefore, evaluating
equipment reliability is based on the concepts of the theory of
probability. Two key parameters are used for the quantitative
characteristic of reliability, viz. the probability of no-failure
operation and the failure rate.

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 The probability of no-failure operation Р(t) is equal to the
ratio of the number of apparatus (or elements) N(t) working at
moment of time t (and serviceable up to this moment), to the initial
number of devices No = N(t=0), i.e.
N( t )
P( t ) 
N0
The failure rate  is equal to the ratio of the rate of failure of
apparatus to the number of working devices:
dN
 .
Ndt
The time dependence of value  has a practically identical
form (Fig. 17.2) irrespective of the type, complexity, and purpose
of devices. It is worth noting that the failure rate for any complex
systems, including biological and medical ones, has such a
dependence. For example, the human death rate is characterized
by a similar diagram.

Fig. 17.2. Time dependence of value 

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 As seen from the diagram, over the initial period, 
decreases in time. At the same time, there is failure of devices
made with some defects. The middle section of the diagram, in
which  remains practically invariable in time, corresponds to the
period of normal operation of faultless equipment. The third
period, in which  grows, corresponds to the period of mass
failures due to aging of materials and deterioration of elements.
In the section of normal operation of devices,  does not
depend on time. Therefore, it is possible to establish a relation
between the probability of no-failure operation and the failure rate:
N(t) = N0e-t,
whence
N( t )  t
P( t )  e .
N0
Thus, in the section of normal operation the probability of no-
failure operation exponentially decreases in time.
Let us consider the classification of medical electronic
equipment by the criterion of reliability. Medical devices or
apparatus fall into four classes depending on the possible
consequences of failure during operation:
 A is units whose failure causes an immediate danger to the
life of the patient or the personnel (life support systems). For
such units, it should be Р0.99 during the service life
established therefor or between scheduled servicing.

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 B is units whose failure causes distortion of information about
the condition of an organism or environment without direct
danger to life of the patient or the personnel, or with danger,
but with a possibility of immediate replacement with a good
unit (Р0.8).
 C is units whose failure reduces the efficiency or delays
treatment-diagnostic process in noncritical situations. The
average operating time before failure should either twice
exceed the period before preventive repair or exceed the
warranty period of operation with an average intensity of
operation.

17.4. METROLOGICAL SERVICE FOR THE PUBLIC

HEALTH SECTOR

Metrology is the science about measurements, i.e. it is a

science of how to carry out measurements, treat measurement
results correctly, and guarantee reliability of measurements.
Respectively, in medical metrology features of measurements in
medicine and respective instruments are considered.
There is a special state metrological service for ensuring the
required accuracy and reproducibility of measurements. Support
of instrument calibration is one of the key tasks of the metrological
service, i.e. determining the accuracy of instruments and
establishing their serviceability. Metrological service agencies
perform calibration by using standards and reference instruments.
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 The standard is a complex of instruments providing
reproducibility and storage of a legalized unit of physical value.
A reference instrument is a device, which is certified as a
reference used for calibrating operating instruments.

17.5. ELECTRODES AND SENSORS

Pickups are classified as electrodes and sensors.

Electrodes are conductors of special form connecting an
instrument with a biological system. Depending on their function,
they can be of various shape, size, and different methods are
used to attach them to a body.
Electrodes are used in monitoring-diagnostic equipment for
pickup of an electric signal, supplying probing electromagnetic
action (for example, in rheography), etc. In physiotherapeutic
equipment, electrodes are used for generating electromagnetic
signals for therapeutic purposes and electrostimulation.
Electrodes should meet the following requirements:
 be attached and removed readily;
 have high stability of electric parameters;
 be durable;
 be noiseless;
 not irritate biological tissue; and
 ensure a minimum level of loss of relevant information.
When making and applying electrodes, it is necessary to
take into account the phenomenon of galvanizing (occurrence of a

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galvanic e.m.f. in contact points of electrodes with biological
tissue) and polarization (electrolytic polarization of electrodes at
excretion of electrolysis products thereon).
Besides metal electrodes, in microelectrode practice, for
example, glass microelectrodes with a tip diameter of about 0.5
m are used. Such electrodes allow to puncture the membrane of
a cell and to carry out endocellular investigation.
Many medical and biologic characteristics cannot be
obtained with electrodes because they have a non-electric nature
(blood pressure, temperature, heartbeat sounds, etc.). In these
cases, sensors are used.
A sensor is a device, which converts a measurable value
into an electric signal, which is easy to transmit for further
conversion.
There are various classifications of sensors. Thus, sensors
are classified as power and bio-controlled ones. Power sensors
produce a signal on their own. This signal first interacts with the
object being investigated, and then it is converted and received by
the same sensor. Bio-controlled sensors receive a signal coming
from the object being investigated. This signal is external with
respect to the sensor.
Bio-controlled sensors are classified as generating and
parametric ones. Under the influence of the signal measured,
generating sensors generate voltage or current directly. For
example, piezoelectric sensors are used for measuring arterial
blood pressure; thermoelectric sensors - for temperature
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measurement; induction sensors - in phonocardiography;
photoelectric sensors - in oxyhemography, etc.
Parametric transducers are those wherein a certain
transducer parameter is measured under the effect of the signal
being measured. There are capacitive, inductive, rheostat
transducers, etc.
Sensors are classified by their purpose. For example, heat-
sensing devices, pressure sensors, photo detectors, etc.
Sensors are classified based on physical phenomena that drive
them. Thus, a piezodetector is based on the piezoelectric effect.
Sensors are classified by the parameter, which varies under
action of an external signal (capacitive, resistive and inductive).
Sensors are characterized by sensitivity, conversion function
and time characteristics.
The conversion function is the output value y(t) vs. input
value x(t) dependence. This dependence can be linear ( y =ax+b),
squared (y = ax2) or any analytical dependence y = f(x).
The sensitivity of a sensor (Z) shows how much the output
signal responses to change of the input:
dy df ( x )
Z  .
dx dx
Time characteristics define the speed and time response of
sensors. For example, a massive thermocouple cannot measure
rapid processes because of its time response.

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 17.6. ELECTRIC SIGNAL AMPLIFIERS

Electric signal amplifiers are devices for amplifying signals

due to the energy of an outside source. Amplifiers of electric
signals are classified as alternating current and direct-current
amplifiers.
Reproduction of the amplified signal without distortion is a
key requirement to amplifiers. This ability of the amplifier can be
evaluated by three characteristics: gain, amplitude response, and
amplitude-frequency response.
Gain ku is the ratio of voltage increment (current intensity or
power) at the amplifier output to the increment of voltage (current
intensity or power) at its input:
U out
kU  ,
Uin
Iout Pout
kI  , kP  .
Iin Pin
Accordingly, voltage, current or power amplifiers are
distinguished. For sake of simplicity, further we will consider
voltage amplifiers.
When amplifying a sinusoidal signal (a.c. amplifiers), the
expression for gain usually uses the amplitudes of input and
output signals:

U out U 0 out
kU   ,
U in U 0 in

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where U0 out and U0 in are the amplitudes of the output and input
signals respectively.
The amplitude response of an amplifier is the output
signal amplitude vs. input signal amplitude dependence
(sometimes it is the gain vs. input signal amplitude dependence).
Ideally, the graph of this response must be a straight line passing
through the origin of coordinates. Thus, the greater the angle
between this line and the X-axis, the greater is the gain.

Uout

Uin
Fig.17.3. Amplitude response of an amplifier

However, the amplitude response of real amplifiers remains

linear only in a certain range of input signal values. If an amplifier
operates in the nonlinear section of the response curve, nonlinear
(amplitude) distortions of the signal occur.
The frequency response of an amplifier is the gain vs.
amplified signal frequency dependence. Any amplifier contains
components whose properties depend on frequency. They are

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capacitances, inductances and others. Therefore, gain ku will
depend on the signal frequency ku=f () .
If the amplified signal is non-sinusoidal, it represents a sum
of signals with different frequencies (harmonics). Therefore,
amplification of various components of the non-sinusoidal signal
with different ku will result in distortion of the initial signal, i.e.
frequency distortion. To prevent this, it is necessary that
ku = const.
In practice, this does not happen. In electronics, it is
supposed that if 0.7ku.max ku ku.max, an amplified signal is
practically nondistorted. The pass band of the amplifier is the
range of frequencies 2-1=  , for which this condition is
satisfied. This parameter has an important practical value since
the band 20 Hz to 20 kHz is sufficient for audio amplification,
whereas 1 to 100 Hz is enough for cardiograph amplification.
ku

ku max

0.7ku max

1 2 , Hz

Fig.17.4. Pass band of the amplifier

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 17.7. GENERATORS

Generators (electronic generators) are devices that

transform energy of power supplies to energy of electromagnetic
oscillations of different form. By their principle of operation, there
are generators with self-excitation (active oscillators) and
oscillators with external excitation (in essence, power amplifiers).
As to impulse waveforms, generators are classified as sinusoidal
(harmonic) and pulse generators.
Generators are characterized by the power of electric
oscillation, repetition rate and waveform.
Generators are widely used in physiotherapeutic electronic
equipment, electronic stimulators and in other devices.

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