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
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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.

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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
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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

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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
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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

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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.
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 Evolutionary product v.s. Revolutionary product Generalized medical instrumentation system

measurand sensor signal conditioning output display auxiliary elements

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Control And feedback Power source Variable Conversion element Signal processing Output display Perceptible output

Sensor Primary Sensing element

Measurand

Calibration signal Radiation, electric current, or other applied energy

Data storage

Data transmission

Figure 1.1 Generalized instrumentation

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Alternative Operational Modes

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

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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.
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Classifications of Biomedical Instruments

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

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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

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Generalized Static Characteristics

Accuracy Precision Resolution Reproducibility Statistical control Static sensitivity, Sensitivity drift Zero drift Linearity
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Characteristic with zero and sensitivity drift Total error due to drift y (Output) y (Output) + Sensitivity drift

D x'd

D y'

Zero drift

Dy Intercept b Dxd

Slope m =

Dy Dxd

+ Zero drift

Sensitivity drift

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

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.
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Generalized Static Characteristics

Input ranges Input impedance

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Generalized Dynamic Characteristics

Differential or Integral equations Transfer functions Time delay

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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.

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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
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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.
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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

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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
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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.

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Conventional v.s. Intelligent Transducer

Conventional transducer
Display Storage Actuator ... Further Processing

Physical or Chemical Parameters

Sensor

Transmission Link

Signal Processing

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Conventional v.s. Intelligent Transducer

Intelligent transducer
Physical or Chemical Parameters Sensing Element & Signal Processing Display Storage Actuator ... Further Processing
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Transmission Link

Signal Processing

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

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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
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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 I Electrical RL Signal Output

Photoconductive cell

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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 Electrical RL Signal Output

Modulated light Y-position

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1. Sensor characteristics 2. Physical Sensors Displacement measurements Resistive Capacitive Inductive Piezoelectric Temperature measurements Optical measurements 3. Chemical Sensors Biochemical
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Electronic Sphygmomanometer
The System Design & Analysis

Student: Cheng-Yu Chen Advisor: Kuo-Sheng Cheng Biomedical Imaging & Instrumentation Lab
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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.

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Introduction (cont.)

Stephen Hales demonstrated the blood pressure in horse in 1733.

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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

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Introduction (cont.)
Korotkovs method

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Introduction (cont.)
The oscillometric method

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System Description
RS-232 Data transmission Display unit Analog signal processing Circuits

Pressure
Microprocessor with A/D converter Signal

Low-Pass Filter

High-Pass Filter
Instrumentation Amplifier

Air pump & valve control circuit

Cuff

Pressure Sensor
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Hardware Design
The system circuits
Display Unit
Pressure Sensor

Analog Signal Processing Circuit

Microprocessor With A/D Converter

RS-232 Data Transmission Air Pump & Valve Control Circuit

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