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 PREFACE

or many years, the tools available to physicians were limited to a few sim-
F ple handpieces such as stethoscopes, thermometers and syringes; med-
ical professionals primarily relied on their senses and skills to perform diag-
nosis and disease mitigation. Today, diagnosis of medical problems is heavi-
ly dependent on the analysis of information made available by sophisticated
medical machineries such as electrocardiographs, video endoscopic equip-
ment and pulmonary analyzers. Patient treatments often involve specialized
tools and systems such as cardiac pacemakers, electrosurgical units, and min-
imally invasive surgical instruments. Such biomedical devices play a critical
and indispensable role in modern-day medicine.
In order to design, build, maintain, and effectively deploy medical de-
vices, one needs to understand not only their use, design and construction
but also how they interact with the human body. This book provides a com-
prehensive approach to studying the principles and design of biomedical
devices as well as their applications in medicine. It is written for engineers
and technologists who are interested in understanding the principles, design,
and applications of medical device technology. The book is also intended to
be used as a textbook or reference for biomedical device technology cours-
es in universities and colleges.
The most common reason for medical device obsolescence is changes in
technology. For example, vacuum tubes in the 1960s, discrete semiconduc-
tors in the 1970s, integrated circuits in the 1980s, microprocessors in the
1990s and networked multiprocessor software-driven systems in today’s
devices. The average life span of medical devices has been diminishing; cur-
rent medical devices have a life span of about 5 to 7 years. Some are even
shorter. Therefore, it is unrealistic to write a book on medical devices and
expect that the technology described will remain current and valid for years.
On the other hand, the principles of medical device and their applications,
the origins of physiological signals and their methods of acquisitions, and the
concepts of signal analysis and processing will remain largely unchanged.
This book focuses on the functions and principles of medical devices (which

vii
viii Biomedical Device Technology

are the invariant components) and uses specific designs and constructions to
illustrate the concepts where appropriate.
The first part of this book discusses the fundamental building blocks of
biomedical instrumentations. Starting from an introduction of the origins of
biological signals, the essential functional building blocks of a typical med-
ical device are studied. These functional blocks include electrodes and trans-
ducers, biopotential amplifiers, signal conditioners and processors, electrical
safety and isolation, output devices, and visual display systems. The next sec-
tion of the book covers a number of biomedical devices. Their clinical appli-
cations, principles of operations, functional building blocks, special features,
performance specifications, as well as common problems, hazards, and safe-
ty precautions are discussed. Architectural and schematic diagrams are used
where appropriate to illustrate how specific device functions are being imple-
mented.
Due to the vast variety of biomedical devices available in health care, it
is impractical to include all of them in a single book. This book selectively
covers diagnostic and therapeutic devices that are either commonly used or
whose principles and design represent typical applications of the technology.
To limit the scope, medical imaging equipment and laboratory instrumenta-
tions are excluded from this book.
Three appendices are included at the end of the book. These are append-
ed for those who are not familiar with these concepts, yet an understanding
in these areas will enhance the comprehension of the subject matters in the
book. They are A-1. A Primer on Fourier Analysis; A-2. Overview of
Medical Telemetry Development; and A-3. Medical Gas Supply Systems.
In this second edition of the book, almost every chapter has been
revised—some with minor updates and some with significant changes and
additions. For those who would like to know more, a collection of relevant
published papers and book references has been added at the end of each
chapter. Based on feedback, a section on “common problems and hazards”
has been included for each medical device. In addition, more information is
provided on the indications of use and clinical applications. Two new areas
of medical device technology have been added in the two new chapters on
Cardiopulmonary Bypass Units and Audiology Equipment.
I gratefully acknowledge the reviewers, educators, and professionals who
provided me with insightful suggestions for this revision. I also would like to
take the opportunity to thank Professor Euclid Seeram for inspiring me into
book publishing, and Michael Thomas for encouraging me to work on this
second edition.

Anthony Y. K. Chan
 CONTENTS

Page
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vii

Chapter
PART I—INTRODUCTION

1. Overview of Biomedical Instrumentation . . . . . . . . . . . . . . . . . . . . . 5

2. Concepts in Signal Measurement, Processing, and Analysis . . . . . . 32

PART II—BIOMEDICAL TRANSDUCERS

3. Fundamentals of Biomedical Transducers . . . . . . . . . . . . . . . . . . . . 51

4. Pressure and Force Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
5. Temperature Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
6. Position and Motion Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
7. Flow Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
8. Optical Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
9. Electrochemical Transducers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
10. Biopotential Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

PART III—FUNDAMENTAL BUILDING BLOCKS

OF MEDICAL INSTRUMENTATION

11. Biopotential Amplifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

12. Electrical Safety and Signal Isolation . . . . . . . . . . . . . . . . . . . . . . . 200
13. Medical Waveform Display Systems . . . . . . . . . . . . . . . . . . . . . . . 222

ix
x Biomedical Device Technology

PART IV—MEDICAL DEVICES

14. Physiological Monitoring Systems . . . . . . . . . . . . . . . . . . . . . . . . . 249

15. Electrocardiographs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
16. Electroencephalographs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291
17. Electromyography and Evoked Potential Study Equipment . . . . . 313
18. Invasive Blood Pressure Monitors . . . . . . . . . . . . . . . . . . . . . . . . . 331
19. Noninvasive Blood Pressure Monitors . . . . . . . . . . . . . . . . . . . . . . 350
20. Cardiac Output Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 363
21. Cardiac Pacemakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 381
22. Cardiac Defibrillators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 401
23. Infusion Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 422
24. Electrosurgical Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 446
25. Pulmonary Function Analyzers . . . . . . . . . . . . . . . . . . . . . . . . . . . . 468
26. Mechanical Ventilators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 485
27. Ultrasound Blood Flow Detectors . . . . . . . . . . . . . . . . . . . . . . . . . 504
28. Fetal Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 514
29. Infant Incubators, Warmers, and Phototherapy Lights . . . . . . . . . 522
30. Body Temperature Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 535
31. Pulse Oximeters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551
32. End-Tidal Carbon Dioxide Monitors . . . . . . . . . . . . . . . . . . . . . . . 566
33. Anesthesia Machines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 573
34. Dialysis Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 590
35. Surgical Lasers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 616
36. Endoscopic Video Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 641
37. Cardiopulmonary Bypass Units . . . . . . . . . . . . . . . . . . . . . . . . . . . 661
38. Audiology Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 676

Appendices
A-1. A Primer on Fourier Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 709
A-2. Overview of Medical Telemetry Development . . . . . . . . . . . . . . . . . . . . . . 714
A-3. Medical Gas Supply Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 718

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 721
BIOMEDICAL DEVICE TECHNOLOGY
 Part I
INTRODUCTION
 Chapter 1

OVERVIEW OF BIOMEDICAL
INSTRUMENTATION

OBJECTIVES

• Define the term medical device.

• Analyze biomedical instrumentation using a systems approach.
• Explain the origin and characteristics of biopotentials and common phys-
iological signals.
• Introduce human factors engineering in medical device design.
• List common input, output, and control signals of medical devices.
• Identify special constraints encountered in the design of biomedical devices.
• Define biocompatibility and list common implant materials.
• Explain tissue responses to foreign materials and state approaches to avoid
adverse tissue reaction.
• Identify the basic functional building blocks of medical instrumentation.

CHAPTER CONTENTS

1. Introduction
2. Classification of Medical Devices
3. Systems Approach
4. Origins of Biopotentials
5. Physiological Signals
6. Human-Machine Interface
7. Input, Output, and Control Signals
8. Constraints in Biomedical Signal Measurements
9. Concepts on Biocompatibility
10. Functional Building Blocks of Medical Instrumentation

5
6 Biomedical Device Technology

INTRODUCTION

Medical devices come with different designs and complexity. They can
be as simple as a tongue depressor, as compact as a rate-responsive demand
pacemaker, or as sophisticated as a surgical robot. Although most medical
devices use technology similar to other consumer or industrial devices, there
are many fundamental differences between devices used in medicine and
devices used in other applications. This chapter will look at the definition of
medical devices and the characteristics that differentiate a medical device
from other household or consumer products.
According to the International Electrotechnical Commission (IEC), a
medical device is

Any instrument, apparatus, implement, appliance, implant, in vitro reagent or

calibrator, software, material or other similar or related article, intended by the
manufacturer to be used alone or in combination for human beings for one or
more of the specific purpose(s) of:
• diagnosis, prevention, monitoring, treatment, or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of, or compensation for an in-
jury,
• investigation, replacement, modification, or support of the anatomy or of a
physiological process,
• supporting or sustaining life,
• control of conception,
• disinfection of medical devices,
• providing information for medical purposes by means of in vitro examination
of specimens derived from the human body, and which does not achieve its
primary intended action in or on the human body by pharmacological, im-
munological or metabolic means, but which can be assisted in its function by
such means.

The United States Food and Drug Administration (FDA), defines a med-
ical device as

An instrument, apparatus, implement, machine, contrivance, implant, in vitro

reagent, or other similar or related article, including a component part, or acces-
sory which is:
• recognized in the official National Formulary, or the United States Pharma-
copoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other
animals, and which does not achieve any of its primary intended purposes
 Overview of Biomedical Instrumentation 7

through chemical action within or on the body of man or other animals and
which is not dependent upon being metabolized for the achievement of any
of its primary intended purposes.

In the Canadian Food and Drugs Act, a medical device is similarly de-
fined as

Any article, instrument, apparatus or contrivance, including any component, part

or accessory thereof, manufactured, sold or represented for use in:
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or
abnormal physical state, or the symptoms thereof, in humans or animals;
(b) restoring, correcting or modifying a body function, or the body structure of
humans or animals;
(c) the diagnosis of pregnancy in humans or animals; or
(d) the care of humans or animals during pregnancy, and at, and after, birth of
the offspring, including care of the offspring, and includes a contraceptive
device but does not include a drug.

Apart from the obvious, it is clear from the preceding definitions that in
vitro diagnostic products such as medical laboratory instruments are medical
devices. Furthermore, accessories, reagents, or spare parts associated with a
medical device are also considered to be medical devices. An obvious exam-
ple of this are the electrodes of a heart monitor. Another example, which may
not be as obvious, is the power adapter to a medical device such as a laryn-
goscope. Both of these accessories are considered as medical devices and are
therefore regulated by the premarket and postmarket regulatory controls.

CLASSIFICATION OF MEDICAL DEVICES

There are many different ways to classify or group together medical de-
vices. Devices can be grouped by their functions, their technologies, or their
applications. A description of some common classification methods follows.

Classified by Functions
Grouping medical devices by their functions is by far the most common
way to classify medical devices. Devices can be separated into two main cat-
egories: diagnostic and therapeutic.
Diagnostic devices are used for the analysis or detection of diseases, in-
juries, or other medical conditions. Ideally, a diagnostic device should not
cause any change to the structure or function of the biological system. Some
diagnostic devices may disrupt the biological system due to their applica-
8 Biomedical Device Technology

tions, however. For example, a real-time blood gas analyzer may require in-
vasive catheters (which puncture the skin into a blood vessel) to take dissolved
carbon dioxide level (PCO2) measurement. A computed tomography (CT)
scanner will impose ionization radiation (transfer energy) on the human body
in order to obtain diagnostic medical images.
Diagnostic devices whose function is to detect changes of certain physi-
ological parameters over a period of time are often referred to as monitoring
devices. Because the main purpose of this class of devices is trending, abso-
lute accuracy may not be as important as repeatability. Examples of monitor-
ing devices are heart rate monitors used to track variation of heart rates dur-
ing a course of drug therapy and noninvasive blood pressure monitors to
assess arterial blood pressure immediately after surgery.
Therapeutic devices are designed to create structural or functional changes
that lead to improved function of the patient. Examples of such devices are elec-
trosurgical units in surgery, linear accelerators in cancer treatment, and infusion
devices in fluid management therapy. Assistive devices are a group of devices
used to restore an existing function of the human body. They may be consid-
ered a subset of therapeutic devices. Examples of assistive devices are demand
pacemakers to restore normal heart rhythm, hearing aids to assist hearing, and
wheelchairs to enhance mobility of people with walking disability.
Based on the methods of application, these device classes can be further
divided into invasive or noninvasive, automatic or manual subcategories.

Classified by Physical Parameters

Medical devices can also be grouped by the physical parameters that they
are measuring. For example, a blood pressure monitor is a pressure-moni-
toring device, a respiration spirometer is a flow-measurement device, and a
tympanic thermometer is a temperature-sensing device.

Classified by Principles of Transduction

Some medical devices are grouped according to the types of transducers
used at the patient-machine interface. Resistive, inductive, and ultrasonic de-
vices are examples in this category.

Classified by Physiological Systems

Medical devices may also be grouped by their related human physiolog-
ical systems. Examples of such grouping are cardiovascular devices (blood
pressure monitors, electrocardiographs, etc.), and pulmonary devices (respi-
rators, ventilators, etc.).
 Overview of Biomedical Instrumentation 9

Classified by Clinical Medical Specialties

In another model, devices are grouped according to the medical special-
ties in which they are being used. For example, a fetal monitor is considered
as an obstetric device, an X-ray machine as a radiological device.

Classified by Risk Classes

For biomedical engineers and regulatory personnel, medical devices are
often referred to by their risk classes. Risk classes are created to differentiate
devices by rating their level of risk on patients. A device risk classification
determines the degree of scrutiny and regulatory control imposed on the
manufacturers and users by regulatory bodies to ensure their safety and effi-
cacy in clinical use. Table 1-1 shows examples of medical devices in each risk
class under the Canadian Medical Device Regulations (MDR). Similar risk
classifications are used in the United States and Europe. Table 1-2 shows the
U.S. FDA risk classifications of some of the devices covered in this book,
with Class 3 devices having the highest risk and Class 1 the lowest risk.

SYSTEMS APPROACH

In simple terms, a system is defined as a group of items, parts, or process-

es working together under certain relationships. Collectively, the processes
in the system transform a set of input entities into a set of output entities.
Within a system there are aspects, variables, or parameters that mutually act
on each other. A closed system is self-contained on a specific level and is sep-
arated from and not influenced by the environment, whereas an open system
is influenced by the environmental conditions by which it is surrounded.
Figure 1-1 shows an example of a system. The elements within a system and
their relationships as well as the environment can affect the performance of
the system. A more complicated system may contain multiple numbers of
subsystems or simple systems.

Table 1-1. Canada MDR Risk Classification

Class I conductive electrode gel, Band-Aids®

Class II latex gloves, contact lenses
Class III IV bags, indwelling catheters
Class IV heart valve implants, defibrillators

Four risk classes—from Class I (lowest risk) to Class IV (highest risk)

10 Biomedical Device Technology

Table 1-2. U.S. FDA Device Risk Classification Examples

Device Risk Class

Electrocardiographs 2
Electroencephalographs 2
Electromyographs 2
Invasive Blood Pressure Monitors 2
Non-Invasive Blood Pressure Monitors 2
Cardiac Output Computers 2
Implantable Pacemakers 3
Cardiac Defibrillators 3
Infusion Pumps 2
Electrosurgical Units 2
Respiration Monitors 2
Mechanical Ventilators 2
Ultrasound Blood Flow Detectors 2
Fetal Scalp ECG Monitors 3
Infant Incubators 2
Body Temperature Monitors 2
Pulse Oximeters 2
Anesthesia Machines 2
Hemodialysis Machines 2
Neurosurgical Lasers 3
Flexible Endoscopes 2
Cardiac Pulmonary Bypass Machines 2
Audiometers 2
Hearing Aids 2
Acoustic Chamber (for hearing test) 1
Cochlear Implants 3

Three risk classes—from Class 1 (lowest risk) to Class 3 (highest risk)

In analyzing a large complex system, one can divide the system into sev-
eral smaller subsystems, with the output from one subsystem connected to
the input of another. The simplest subsystem consists of an input, an output,
and a process as shown in Figure 1-2. The process that takes the output and
feeds it back to the input in order to modify the output is called a feedback
process. A system with feedback is called a closed-loop system, whereas a
system without any feedback is called an open-loop system. Most systems
that we encounter contain feedback paths and hence are closed-loop sys-
tems.
Listening to radio is an example of a simple closed-loop system. The
input to the system is the radio broadcast in the form of an electromagnetic
wave that is received by the radio. The radio processes the received signal
 Overview of Biomedical Instrumentation 11

Figure 1-1. Typical System.

Figure 1-2. Basic Subsystem.

and produces the audible sound such as music. If the music (output) is not
loud enough, the listener turn up the volume to increase the sound level. In
doing this, the listener becomes the feedback process that analyzes the loud-
ness of the music and invokes the action to turn up the volume.
The systems approach is basically a generalized technique to understand
organized complexity. It provides a unified framework or a way of thinking
about the systems and can be developed to handle specific problems. In ord-
er to solve a problem, one must look at all components within the system and
analyze the input and output of each subsystem in view to isolate the prob-
lem and establish the relationships of the problem with respect to each com-
ponent in the system.
Using block diagrams to analyze complex devices is an application of the
systems approach. Figure 1-3 shows a music player system. The input to the
player is the musical file either from a flash memory, radio broadcast, or the
Internet, the output is sound (or music), and the feedback is the listener who
will switch to another file when it has finished playing or turn down the vol-
12 Biomedical Device Technology

Figure 1-3. Music Player System.

Figure 1-4. Music Player Functional Block.

ume if it is too loud. If the player is not working properly, one may buy a
new one and discard the malfunctioning unit.
The music player can be divided into its functional blocks, as shown in
Figure 1-4. One may be able to troubleshoot and isolate the problem to one
of the functional blocks (or component). In this case, it will be cheaper just
to replace the malfunctioning block. For example, if the speakers are not
working, it may be more economical to get a pair of replacement speakers
than to replace the entire music player.
Similarly, a complex biomedical device can be broken down into its
functional building blocks. Figure 1-5 shows a block diagram of an electro-
cardiography (ECG) system. The input to the device is the biopotential from
the heart activities. The electrodes pick up the tiny electrical signals from the
patient and send them to the amplifier block to increase the signal amplitude.
The amplified ECG signal is then sent to the signal analysis block to extract
information, such as the heart rate. Finally, the ECG signal is sent to the out-
put block, such as a paper chart recorded to produce a hard copy of the ECG
tracing. These blocks can be further subdivided, eventually down to the indi-
vidual component level. Note that the cardiology technologist is also consid-
 Overview of Biomedical Instrumentation 13

Figure 1-5. ECG Block Diagram.

ered to be a part of the system. He or she serves as the feedback loop by

monitoring the output and modifying the input.
When analyzing or troubleshooting a medical device, it is important to
understand the functions of each building block and what to expect from the
output when a known input is applied to the block. Furthermore, medical
devices are, in most cases, conceptualized, designed, and built from a com-
bination of functional building blocks or modules.

ORIGINS OF BIOPOTENTIALS

The source of electrical events in biological tissue is the ions in the elec-
trolyte solution, as opposed to the electrons in electrical circuits. Biopotential
is an electrical voltage caused by a flow of ions through biological tissues. It
was first studied by Luigi Galvani, an Italian physiologist and physicist, in
1786. In living cells, there is an ongoing flow of ions (predominantly sodium
[Na+], potassium [K+] and chloride [Cl–]) across the cell membrane. The cell
membrane allows some ions to go through readily but resists others. Hence
it is called a semipermeable membrane.
There are two fundamental causes of ion flow in the body: diffusion and
drift. Fick’s laws state that if there is a high concentration of particles in one
region and they are free to move, the particles will flow in a direction that
equalizes the concentration; the force that results in the movement of charges
is called diffusion force. The movement of charged particles (such as ions)
that is due to the force of an electric field (static forces of attraction and repul-
sion) constitutes particle drift. Each cell in the body has a potential difference
across the cell membrane known as the single-cell membrane potential.
Under equilibrium, the net flow of charges across the cell membrane is
zero. However, due to an imbalance of positive and negative ions internal
and external to the cell, the potential inside a living cell is about –50 milli-
volts (mV) to –100 mV with respect to the potential outside it (Figure 1-6).
14 Biomedical Device Technology

Figure 1-6. Cell Membrane Potential.

This membrane potential is the result of the diffusion and drift of ions across
the high-resistance but semipermeable cell membrane, predominantly sodi-
um [Na+] and potassium [K+] ions moving in and out of the cell. Because of
the semipermeable nature of the membrane, Na+ is partially restricted from
passing into the cell. In addition, a process called the sodium-potassium
pump moves sodium ions at two to five times the rate out of the cell than it
moves potassium ions into the cell. In the presence of diffusion and drift,
however, an equilibrium point is established when the net flow of ions across
the cell’s membrane becomes zero. Because there are more positive ions
(Na+) moved outside the cells than there are positive ions (K+) moved into the
cell, under equilibrium, the inside of the cell is more negative than the out-
side is. Therefore, the inside of the cell is negative with respect to the outside.
This is called the cell’s resting potential, which is typically about –70 mV.
If the potential across the cell membrane is raised, for example by an
external stimulation, to a level that exceeds the threshold, the permeability
of the cell membrane will change, causing a flow of Na+ ions into the cell.
This inrush of positive ions will create a positive change in the cell’s mem-
brane potential to about 20 to 40 mV more positive than the potential out-
side the cell. This action potential lasts for about 1 to 2 milliseconds (msec).
As long as the action potential exists, the cell is said to be depolarized. The
membrane potential will drop eventually as the sodium-potassium pump
repolarizes the cell to its resting state (–70 mV). This process is called repo-
larization and the time period is called the refractory period. During the
refractory period, the cell is not responsive to any stimulation. The events of
depolarization and repolarization are shown in Figure 1-7. The rise in the
membrane potential from its resting stage (when stimulated) and return to the
resting state is called the action potential. Cell potentials form the basis of all
electrical activities in the body, including such activities as the electrocardio-
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