Biomedical Instrumentation

Webster Chapter -1

Introduction

Medical Instrument

Invasive, noninvasive; external, implanted

Diagnostic, therapeutic
detect biochemical, bioelectrical, or biophysical
parameters
reproduce the physiologic time response of these
parameters
provide a safe interface with biological materials

Examples

Endocardial catheter; ECG electrodes and monitor

External & implanted pacemakers, defibrillators
EEG based neurological monitor; deep brain
stimulator for Parkinsons disease

General Medical Instrumentation

System
Control
And
feedback

Power
source

Sensor

Measurand

Primary
Sensing
element

Variable
Conversion
element

Calibration
signal

Signal
processing

Output
display

Data
storage

Data
transmission

Perceptible
output

Radiation,
electric current,
or other applied
energy
Figure 1.1 Generalized instrumentation system The sensor converts energy or information from the
measurand to another form (usually electric). This signal is the processed and displayed so that humans can
perceive the information. Elements and connections shown by dashed lines are optional for some applications.

Characteristics of Physiological Signals

Parameter

Measurement
Range

Frequency
Range

Measurement Method

Electrocardiogram
(ECG)

0.5 4mV

0.01 250Hz

Skin electrodes

Electroencephalogram (EEG)

5 300V

DC 150Hz

Scalp electrodes

Electromyogram
(EMG)

0.1 5mV

DC 10KHz

Needle/skin electrodes

Electrooculogram
(
(EOG)
)

50 3500V

DC 50Hz

Contact electrodes

Blood flow

1 300mL/sec

DC 20Hz

Ultrasonic flowmeter

Respiratory Rate

2 50 breaths/min

0.1 10Hz

Strain guage

Body Temperature

32 40 oC

DC 0.1Hz

Thermistor/thermocouple

Examples of Medical Instruments

Implanted pacemaker
External ECG monitor
nerve stimulator
Laser for coronary angioplasty
X ray or imaging devices
Electrosurgical instrument
Pulse oximeter
Defibrillation electrode
Infrared thermometer
Automatic blood pressure

Interference

System Block Diagram

Induced

Transfer Function
Output
Input

Instrument
System

Signal
source
Internal
interference

(added)

Any measurement includes

signal+noise
Signal sources: ECG. EEG, blood
pressure, temperature
Noise sources
External: 60 Hz, radio
frequency (RF), magnetic
Internal: muscle noise, motion
artifact, eye blink artifact

General instrument static characteristics of

Static System Properties

Accuracy (True (from NIST)measured)

Precision (No of significant
digits)
Resolution (smallest
measurable qty)
Reproducibility (give same
output)
Statistical control (variation of
meas red q
measured
quantities
antities in tolerable
limits)
Static sensitivity slope, zerodrift (ambient surroundings),
sensitivity drift (ex power supply
fluctuations)
More next slide

Static system properties cont.

Linearity (not all instruments have a

perfect linear response; deviation
from linear fit line is necessary
nonlinearity
Input Dynamic Range - ratio
between the maximum undistorted
signal (i.e., maximum input signal
satisfying the linearity specification
for the sensor) and the minimum
detectable signal for a given set of
operating conditions expressed in
dB
Input Impedance the
instantaneous rate at which energy
is transferred by a system

LINEARITY
x1

Linear
System

y1

x2

Linear
System

y2

x1 + x2

Linear
System

y1 + y2

Kx1

Linear
System

Ky1

Generalized Dynamic Characteristics

Most biomedical instruments must process signals that change with time.
The dynamics of the measurement system, therefore, must be chosen to properly
reproduce the dynamics of the physiologic variables the system is sensing.
Mostly, we will deal with consider linear, time invariant systems unless otherwise
explicitly noted.
For such systems,
systems the dynamics can be fully described by simple differential
equations of the form:

an

dx
dy
d mx
dny
+ ... + a1
+ a0 y (t ) = bm m + ... + b1
+ b0 x(t )
n
dt
dt
dt
dt

where x(t) is the input signal (usually the physiologic parameter of interest), y(t) is the
output signal (usually the electronic signal), and the as and bs are constants
determined by the physical characteristics of the sensor system.
Most practical sensor front-ends are described by differential equations of zero, first
or second order (i
(i.e.,
e n=0
n 0,1,2),
1 2) and derivatives of the input are usually absent
absent, so
m=0.
Linear, time invariant systems are simply characterized by their response to
sinusoidal inputs of the form x(t) = A sin(wt), where the output is a sinusoid at
precisely the same frequency of the form y(t) = B(w) sin(wt + f(w)).

H ( j ) =

Y ( j ) bm ( j ) m + ... + b1 ( j ) + b0
=
X ( j ) an ( j ) n + ... + a1 ( j ) + a0

Zero-Order System

Expression of the inputoutput relationship

Time-domain
R l ti
Relationship
hi

Transfer Function

a0 y (t ) = b0 x(t )

H ( j ) =

b0
a0

Example
Linear potentiometer

First-Order System

System contains a single energy-storage element

Time-domain relationship
a1

Transfer Function
H ( j ) =

dy
+ a0 y (t ) = b0 x (t )
dt

or

b0
a1 ( j ) + a0

Example
RC Low-pass or High-pass Filters

RC circuit and response

Output y(t)

R
+

x(t)

Slope = K = 1

y(t)

Input
p x(t)
()
(a)

(b)

Figure 1.6 (a) A low-pass RC filter, an

example of a first-order instrument. (b)
Static sensitivity for constant inputs. (c)
Step response for larger time constants (L)
and small time constants (S). (d)
Sinusoidal frequency response for large
and small time constants.

Log
scale

x(t)

Y (j)
X (j)

1.0
0.707

S
L

(c)

Log scale

y(t)

0.63

45

(d)

Log scale

90
t

Second-Order System

Second-order system can approximate higher-order systems

Time-domain Relationship

a2

d2y
dy
+ a1
+ a0 y (t ) = b0 x(t )
2
dt
dt

Transfer Function

Overdamped

a1
=
>1
2 a0 a 2

Underdamped

a1
=1
2 a0 a 2

Critically Damped

a1
<1
2 a0 a 2

Food and Drug Administration (FDA)

Government body entrusted with the responsibility to
regulated
l t d medical
di l d
devices,
i
d
drugs, etc.
t
Primary task: certify safety and efficacy
FDA regulates through
Instrumentation Categories

FDA

Design Control

Class I

Process Control

Class II

Good Manufacturing Practices

Class III

FDA Device Regulations

Class I General Controls

Class II Performance Standards

Required to perform registration,

registration labeling
labeling, and good
manufacturing practices and to report adverse effects
Required to prove substantial equivalence via the 510(k)
process

Class III Pre-market Approval (PMA)

Requires extensive testing and expert scrutiny

PMA is necessary for devices used in supporting or
sustaining human life