Bioinstrumentation

Medical Instrumentation: Application and Design Third Edition

John G. Webster, Editor

Kuo-Sheng Cheng, Ph.D.

Department of Biomedical Engineering
National Cheng Kung University
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

The Importance of Medical

Instrumentation
Diagnosis and therapy depend heavily on
the use of medical instrumentation.
Medical procedures:
Medicine can be defined as a multistep procedure
on an individual by a physician, group of
physician, or an institute, repeated until the
symptoms disappear.

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

The Importance of Medical

Instrumentation
Medical procedure
1) Collection of data - qualitative and/or
quantitative
2) Analysis of data
3) Decision making
4) Treatment planning based on the decision
5) Repeat
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

A Story of New Medical Device

The invention, prototype design, product
development, clinical testing, regulatory
approval, manufacturing, marketing, and
sale of a new medical instrument add up a
complex, expensive, and lengthy process.
A success story - Technicons Auto
Analyzer

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Development of Technicons Auto

Analyzer
The inventor - Leonard Skeggs,
Chair of Department of Pathology at Case
Western Reserve University - Dr. Alan
Moritz
Technicon Corporation founders - Edwin C.
Whitehead, and his father
a four-page confidential disclosure form
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Development of Technicons Auto

Analyzer
Two key persons to recall the invention Technicons only salesman, Ray Roesch,
and the doctor at the Cleveland Veterans
Adminstration Hospital, Joseph Kahn.
Patent application and protection
Marketing strategy

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Development of Technicons Auto

Analyzer
Factors affected the success
it allows an enormous improvement in quality
of laboratory test results, and an enormous
reduction in the cost of doing chemical analysis.
accurate laboratory data are useful in diagnosis.
reimbursement policies increase the availability
of health care.
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

 Evolutionary product v.s. Revolutionary

product
Generalized medical instrumentation system

measurand
sensor
signal conditioning
output display
auxiliary elements

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Control
And
feedback
Power
source

Sensor

Measurand

Primary
Sensing
element

Calibration
signal

Variable
Conversion
element

Signal
processing

Output
display

Data
storage

Data
transmission

Perceptible
output

Radiation,
electric current,
or other applied
energy

Figure 1.1 Generalized instrumentation

Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Alternative Operational Modes

Direct-Indirect modes
Sampling and Continuous modes
Generating and Modulating sensors
Analog and Digital Modes
Real-time and Delayed-time Modes

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Medical Measurement Constraints

Many crucial variables in living systems are
inaccessible.
Variables measured are seldom
deterministic.
Nearly all biomedical measurements depend
on the energy.
Operation of instruments in the medical
environment imposes important additional
constraints.
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Classifications of Biomedical
Instruments

The sensed quantity

The principle of transduction
The organ system for measurement
The clinical medicine specialities

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Classifications of Biomedical
Instruments
Based on the activities involved in the
medical care, medical instrumentation may
be divided into three categories:
diagnostic devices
therapeutic devices
monitoring devices

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Generalized Static Characteristics

Accuracy
Precision
Resolution
Reproducibility
Statistical control
Static sensitivity, Sensitivity drift
Zero drift
Linearity
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Characteristic with zero and sensitivity drift

Total error due to drift
y (Output)
y (Output)

D x'd

+ Sensitivity
drift

D y'

Dy
Intercept b

Slope m =

Dxd

Dy
Dxd

+ Zero
drift

Zero drift

Sensitivity drift

y = mxd + b
xd (Input)
(a)

xd (Input)
(b)

Figure 1.3 (a) Static-sensitivity curve that relates desired input xd to output y.
Static sensitivity may be constant for only a limited range of inputs. (b) Static
sensitivity: zero drift and sensitivity drift. Dotted lines indicate that zero drift
and sensitivity drift can be negative.
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Generalized Static Characteristics

Input ranges
Input impedance

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Generalized Dynamic Characteristics

Differential or Integral equations
Transfer functions
Time delay

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Figure 1.8 Design

process for medical
instruments Choice
and design of
instruments are
affected by signal
factors, and also by
environmental,
medical, and
economic factors.

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Regulation of Medical Devices

1976 - Medical Device Amendments to the
Federal Food, Drug, and Cosmetics Act
1990 - Safe Medical Devices Act
Medical Device: any item promoted for a
medical purpose that does not rely on
chemical action to achieve its intended
effect
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Regulation of Medical Devices

Medical devices were classified in two
ways:
Class I (general controls), Class II
(performance standards), and Class III
(premarketing approval)
Preamendment, Postamendment, Substantially
equivalent, implant, custom, investigation, and
transitional.
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Biomedical Transducer
Measuring is the key to understand, and transducer plays
an important role in measurement.

Kuo-Sheng Cheng, Ph.D.

Institute of Biomedical Engineering

National Cheng Kung University
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

What is the Transducers?

In principle, Transducers are devices that
convert signals in one form of energy into
signals in another form of energy.
Sensors
Actuator
Conventional v.s. Intelligent Transducers
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

What are the Transduers, Sensors, and

Actuators?
Transducer - A device that converts energy
of one form to another.
Sensor - A device that converts a physical
parameter to an electric output.

Actuator - A device that converts an electric

signal to a physical output.
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Conventional v.s. Intelligent

Transducer
Conventional transducer

Physical
or
Chemical
Parameters

Sensor

Transmission
Link

Signal
Processing

Display
Storage
Actuator
...
Further
Processing

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Conventional v.s. Intelligent

Transducer
Intelligent transducer
Physical
or
Chemical
Parameters

Sensing Element
&
Signal Processing

Transmission
Link

Signal
Processing

Display
Storage
Actuator
...
Further
Processing
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Transducer Categories
By application
By physical or chemical principles used
By the process used to convert the signal
energy into an electrical signal

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Three types of output signal

Self-generating (active) transducers:
The electrical signal output of transducer is
generated from another form of input energy.
e.g.
Light
in

Electrical
RL Signal
Output

Photovoltaic cell
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Three types of output signal

Modulating (passive) transducer:
The input signal energy of transducer is used to
modulate the electrical energy flow from the
power supply to the transducer output.
e.g.
Light
in

Photoconductive cell

Electrical
RL Signal
Output

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Three types of output signal

Tandem transducers:
The original input signal energy is converted to
a final output of electrical energy through two
or three effects or conversions in tandem.
e.g.
Light in

Photoconductive cell
I

Modulated
light
Y-position

Electrical
RL Signal
Output

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

1. Sensor characteristics
2. Physical Sensors
Displacement measurements
Resistive
Capacitive
Inductive
Piezoelectric
Temperature measurements
Optical measurements
3. Chemical Sensors
Biochemical
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Electronic Sphygmomanometer
The System Design & Analysis

Student: Cheng-Yu Chen

Advisor: Kuo-Sheng Cheng
Biomedical Imaging & Instrumentation Lab
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Introduction
The blood pressure measurement
-Invasive method
Stephen Hales placed a glass tube in the artery of horse for blood
pressure measurement in 1733.
The measurement of blood pressure with a mercury sphygmomanometer
was first invented by J. M. Poiseuille in 1828.

-Noninvasive method
Limb-occluding device that contained an arm cuff was first invented by
S. Riva-Rocci in 1896.
L. Hill and H. Barnard published a modified sphygmomanometer with
cuff in 1898.
N. S. Korotkov invented an auscultatory measurement of systolic and
diastolic blood pressure in 1905.

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Introduction (cont.)

Stephen Hales demonstrated the

blood pressure in horse in 1733.

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Introduction (cont.)

Riva-Roccis
sphygmomanometer, 1896

Blood pressure
measurement using
Korotkovs method, 1905

*E. OBrien and D. Fitzgerald, The history of indirect blood

pressure measurement, Handbook of Hypertension, Vol. 14: Blood
Pressure Measurement

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Introduction (cont.)
Korotkovs method

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

Introduction (cont.)
The oscillometric method

Medical Imaging &

Instrumentation Laboratory

BME, NCKU

System Description
RS-232 Data
transmission

Analog signal
processing Circuits

Display unit

Pressure

Low-Pass Filter

High-Pass Filter

Microprocessor
with A/D converter

Signal

Air pump & valve

control circuit

Cuff

Instrumentation
Amplifier

Pressure
Sensor
Medical Imaging &
Instrumentation Laboratory

BME, NCKU

Hardware Design
The system circuits
Display Unit
Pressure
Sensor

Microprocessor
With A/D
Converter

Analog Signal
Processing Circuit

RS-232 Data
Transmission
Air Pump & Valve
Control Circuit
Medical Imaging &
Instrumentation Laboratory

BME, NCKU