GENERAL CONSTRAINTS IN

DESIGN OF MEDICAL
INSTRUMENTATION SYSTEM
Presented by,
Abhyarthana Bisoyi
Assistant Professor
School of Electronic Sciences
Odisha University of Technology and Research (OUTR)
INTRODUCTION
 Medical equipment are primarily used for making measurements of
physiological parameters of the human body and also in some cases a
stimulus or some kind of energy is applied to the human body for diagnosis
and treatment.
 Some of the important factors, which determine the design of a medical
measuring instrument, are:
 Measurement Range: Generally the measurement ranges are quite low compared with
non-medical parameters. Most signals are in the microvolt to millivolt range.
 Frequency Range: Most of the bio-medical signals are in the audio frequency range or
below and that many signals contain dc and very low frequency components.
 These general characteristics of physiological signals limit the practical
choices available to designers of medical instruments.
 Besides, there are some additional constraints, which need to be considered
while designing a measurement system for medical applications.
general constraints in design of medical Instrumentation system 2
1. INACCESSIBILITY OF THE SIGNAL SOURCE:
 One of the major problems in making measurements from a living system is
the difficulty in gaining access to the source of the physiological variable
being measured.
 For example; measurement of intracranial pressure in the brain requires the
placement of a sensor in the brain, which is quite a difficult task.
 Besides, the physical size of many sensors may put a constraint for its use on
the area of interest.
 Evidently, such inaccessible physiological variables must be measured
indirectly.
 The typical example of making indirect measurement of blood pressure on
the brachial artery is that of using cuff-based Korotoff method.
 In such cases, corrections need to be applied to data that might have been
affected due to the indirect measuring process.
general constraints in design of medical Instrumentation system 3
2. VARIABILITY OF PHYSIOLOGICAL PARAMETERS:
 Physiological variables of interest for measurement from the human body are
rarely deterministic as they are generally time-variant.
 In other words, many medical measurements vary widely among normal
patients even when conditions are similar.
 Therefore, the physiological variable must be represented by some kind of
empirical, statistical and probabilistic distribution function.
 Many internal anatomical variations exist among patients and therefore, the
variability of physiological parameters from one patient to another is a normal
observation.
 Therefore, statistical methods are employed in order to establish relationships
among variables.

general constraints in design of medical Instrumentation system 4

3. INTERFERENCE AMONG PHYSIOLOGICAL SYSTEMS:
 Many feedback loops exist among physiological systems and many of the
interrelationships amongst them contribute to this inherent variability of
physiological signals.
 In other words, stimulation of one part of a given system generally affects all
other parts of that system in some way.
 Also, unlike many complex non-medical systems, a biological system is of
such a nature that it is not possible to turn it off and remove parts of it during
measurement procedure to avoid interference from undesirable
physiological signals.

general constraints in design of medical Instrumentation system 5

4. TRANSDUCER INTERFACE PROBLEMS:
 All measurement systems are affected in some way by the presence of the
measuring transducer.
 The problem gets compounded while making measurement on the living
system where the physical presence of the transducer may change the
reading significantly.
 Also, the presence of a transducer in one system can affect responses in
other systems.
 Adequate care needs to be taken while designing a measuring system to
ensure that the loading effect of the transducer is minimal on the source of
the measured variable.

general constraints in design of medical Instrumentation system 6

5. HIGH POSSIBILITY OF ARTIFACTS:
 The term artifact refers to an undesirable signal that is extraneous to the
physiological variable under measurement.
 The examples of artifacts are 50 Hz electrical interference, cross talk and
noise generated within the measuring instrument.
 A major source of artifacts in medical instruments is due to the movement of
the subject.
 Many of the transducers are sensitive to the movement and therefore, the
movement of the subject result in generating spurious signals, which may
even be large enough to obscure the signal of interest.
 This type of situation puts a heavy demand on the signal conditioning part
of the measurement system.

general constraints in design of medical Instrumentation system 7

6. SAFE LEVELS OF APPLIED ENERGY:
 Nearly all biomedical measurements require some form of energy to be
applied to the living tissue or some energy gets applied as an incidental
consequence of transducer operation.
 For example, ultrasonic imaging techniques depend upon externally
applied ultrasound energy to the human body.
 Safe levels of the various types of energy on the human subjects are difficult
to establish.
 However, designers of medical instruments depend upon a large number of
studies carried out by numerous researchers, which establish the threshold
of adverse affects by the applied energy

general constraints in design of medical Instrumentation system 8

7. PATIENT SAFETY CONSIDERATIONS:
 Medical instruments have to be physically connected to the patient in some
way or the other.
 In case it happens to be an electric or electronic equipment, the possibility
of an electric shock hazard is very strong unless adequate measures have
been taken in the design of the equipment.
 Inaddition, the equipment is used by non-technical medical and
paramedical staff and their safety needs also to be ensured.
 Various organisations at national and international level have laid down
specific guidelines to provide for the safety and effectiveness of the medical
devices intended for use on human subjects.

general constraints in design of medical Instrumentation system 9

8. RELIABILITY ASPECTS:
 In case of life saving equipment like defibrillators, their failure to operate or
provide desired output can become a potential life threat for the patient.
 Therefore, equipment must be reliable, simple to operate and capable of
withstanding physical abuse due to transportation within the hospital or in
the ambulances and exposure to corrosive chemicals.

general constraints in design of medical Instrumentation system 10

9. HUMAN FACTOR CONSIDERATIONS:
 As a result of the increasing complexity of medical devices and systems, the
demand of physicians and paramedical staff using the equipment continue to grow.
 The equipment requires a high amount of information exchange between itself and
the user in order to monitor and control the technical functions of the system.
 Furthermore, medical staff generally has only little experience in working with
complex technical system.
 There is a risk that the medical staff is not able to master the equipment adequately
for every task.
 This inadequacy can increase the probability of error and reduce the quality and
reliability of a clinical procedure.
 As a result, the desired or intended performance of the whole system may not be
achieved due to deficiencies in man-machine interaction.
 The user interface design issues therefore assume more and more importance in
case of medical equipment.
general constraints in design of medical Instrumentation system 11
10. GOVERNMENT REGULATIONS:
 During the initial stages of introduction of technology and a range of
diagnostic and therapeutic devices in the medical field, there was almost no
government control on their design, testing and sales.
 Situation is rapidly changing and government regulations are being
introduced to ensure that the equipment perform their intended function
and are safe to operate and function.
 Designers of medical instruments should therefore be fully conversant with
all such regulations on a particular product or system issued by national and
international agencies.
 It is thus obvious that there are many factors that impose constraints on the
design of medical instruments.

general constraints in design of medical Instrumentation system 12

 In addition to these, there are general considerations, which need to be
considered into the initial design and development of a medical instrument.
 These factors are:
 Signal Considerations: Type of sensor, sensitivity, range, input impedance,
frequency response, accuracy, linearity, reliability, differential or absolute
input.
 Environmental Considerations: Signal-to-noise ratio, stability with respect
to temperature, pressure, humidity, acceleration, shock, vibration,
radiation etc.
 Medical Considerations: Invasive or non-invasive technique, patient
discomfort, radiation and heat dissipation, electrical safety, material
toxicity etc.
 Economic Considerations: Initial cost, cost and availability of consumables
and compatibility with existing equipment.
general constraints in design of medical Instrumentation system 13