Chapter 1-Webster

Basic Concepts of Medical

Instrumentation
Figure 1.1 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.
Perceptible
output
Output
display
Control
And
feedback
Signal
processing
Data
transmission
Data
storage
Variable
Conversion
element
Sensor
Primary
Sensing
element
Measurand
Calibration
signal
Radiation,
electric current,
or other applied
energy
Power
source
Generalized instrumentation system
Measurand: Physical quantity
Biopotential
Pressure
Flow
Dimensions (imaging)
Displacement (velocity, acceleration, force)
Impedance
Temperature
Chemical Concentration
Sensor and Transducer
Transducer
Converts one form of energy to another
Sensor
Converts a physical measurand to an electrical
output
Interface with living system
Minimize the energy extracted
Minimally invasive
diaphragm
Strain gage
pressure
displacement electric voltage
Signal Conditioning
Amplification
Filtering
Impedance matching
Analog/Digital for signal processing
Signal form (time and frequency domains)
Output Display
Numerical
Graphical
Discrete or continuous
Visual
Hearing
Auxiliary Element
Calibration Signal
Control and Feedback (auto or manual)
Adjust sensor and signal conditioning

1.3 Alternative Operational Modes
Direct Mode: Measurand is readily accessible
Temperature
Heart Beat
Indirect Mode: desired measurand is measured by
measuring accessible measurand.
Morphology of internal organ: X-ray shadows
Volume of blood pumped per minute by the heart:
respiration and blood gas concentration
Pulmonary volumes: variation in thoracic impedance

1.3 Sampling and Continuous Modes
Sampling and collecting data will depend on the
following:
The rate of change in the measurand
Condition of the patient
Generating and Modulating Sensors
Generating sensors produce their outputs from energy taken
from measurand (Photovoltaic cell)
Modulating Sensors uses the measurand to alter the flow of
energy from an external source (Photoconductive cell)
Analog and Digital Modes
Real-Time and Delayed-Time Modes
1.4 Medical Measurement Constraints
Magnitude and frequency range of medical
measurand are very low
Proper measurand-sensor interface cannot be
obtained
Medical variables are seldom deterministic
External energy must be minimized to avoid
any damage
Equipment must be reliable

1.5 Classification of Medical Instrument
Quantity that is sensed
pressure, flow, temp
Principle of transduction
resistive, capacitive, electrochemical, ultrasound
Organ system
cardiovascular, pulmonary, nervous
Medicine specialties
pediatrics, cardiology, radiology
1.6 Interfering and Modifying Inputs
Desired Inputs: measurands that the instrument is
designed to isolate.

Interfering Inputs: quantities that unintentionally affect
the instrument as a consequence of the principles used to
acquire and process the desired inputs.

Modifying Inputs: undesired quantities that indirectly
affect the output by altering the performance of the
instrument itself.
Figure 1.2 Simplified electrocardiographic recording system Two possible interfering inputs are
stray magnetic fields and capacitively coupled noise. Orientation of patient cables and changes in
electrode-skin impedance are two possible modifying inputs. Z
1
and Z
2
represent the electrode-skin
interface impedances.
Electrodes
60-Hz
ac magnetic
field
Displacement
currents
Differential
amplifier
+

+ V
cc
-V
cc

Z
1
Z
body
Z
2
v
o
v
ecg
1.6 Interfering and Modifying Inputs
Desired input: Electrocardiographic voltage V
ecg
Interfering input: voltage due to 60-Hz
1.7 Compensation Techniques
To eliminate interfering and modifying input:
1. Alter the design of essential instrument components to
be less sensitive to interference. (preferred)
2. Adding new components designed to offset the
undesired inputs.
1.7 Compensation Techniques
Inherent Insensitive
Negative Feedback to minimize G
d
which is
effected by the modifying inputs
(x
d
H
f
y)G
d
= y (1.1)
x
d
G
d
= y(1 + H
f
G
d
) (1.2)

(1.3)

Signal Filtering (electric, mechanical, magnetic)
Opposing Inputs
d
d f
d
1
x
G H
G
y
+
=
Compensation Techniques- Example
An amplifier with gain 10 that has 20%
fluctuation due to temperature and
environmental change. How will compensate
the system to minimize the fluctuation?
1.8 Biostatistics
Applications of Statistics to medical data
-Design experiment
-Clinical Study: summarize, explore, analyze
-Draw inference from data: estimation, hypothesis
-Evaluate diagnostic procedures: assist clinical decision
making
Medical Research Studies
- Observational: Characteristics of patients are observed
and recorded
-Case-series: describe characteristic of group
-Case-control: observe group that have some disease
-Cross-sectional: Analyze characteristics of patients
-Cohort: determine if a particular characteristic is a precursor
for a disease.
-Experimental Intervention: Effect of a medical
procedure or treatment is investigated
-Controlled: Comparing outcomes to drug and placebo
-Uncontrolled: No placebo and no comparison
-Concurrent controls: patient are selected the same way and for the same time.
-Double-blind
n
X
X
i
=
n
n
X X X X GM =
3 2 1
Statistical Measurements
Measures of the mean and central tendency
-Mean

-Median: Middle value (used for skewed data)
-Mode: is the observation that occurs most frequently
-Geometric Mean: used with data on a logarithmic
scale
( )
1
2

=

n
X X
s
i
( ) % 100
|
.
|

\
|
=
X
s
CV
Statistical Measurements
Measure of spread or dispersion of data
Range: Difference between the largest and smallest
observation
Standard deviation: is a measure of the spread of data
about the mean


For symmetric distribution 75% of the data lies between
(mean - 2s) and (mean + 2s)
Coefficient of variation: standardize the variation to
compare data measured in different scales.
( )( )
( ) ( )

=
2 2
Y Y X X
Y Y X X
r
i i
i i
Statistical Measurements
Percentile: gives the percentage of a distribution
that is less than or equal to the percentile number.
Standard error of the mean (SEM): Express the
variability to be expected among the mean in future
samples.
Correlation Coefficient r: is a measure of a linear
relationship between numerical variables x and y for
paired observations
Methods for inference about a value in a
population of subjects from a set of
observations.
Estimation and confidence of interval:
are used to estimate specific parameters such as the
mean and the variance.
Hypothesis testing and P-value:
reveals whether the sample gives enough evidence
for us to reject the null hypothesis. P-value
indicates how often the observed difference would
occur by chance alone.
Methods for measuring the accuracy of a
diagnostic procedure
Sensitivity of a test: Probability of its
yielding positive results in patients who
actually have the disease.
Specificity of a test: Probability of its
yielding negative results in patients who do
not have the disease
Prior Probability: the prevalence of the
condition prior to the test.

Characteristics of Instrument Performance
Two classes of characteristics are used to
evaluated and compare new instrument
Static Characteristics: describe the
performance for dc or very low frequency
input.
Dynamic Characteristics: describe the
performance for ac and high frequency input.


1.9 Generalized Static Characteristics
Parameters used to evaluate medical instrument:
Accuracy: The difference between the true value and
the measured value divided by the true value
Precision: The number of distinguishable alternatives
from which a given results is selected {2.434 or 2.43}
Resolution: The smallest increment quantity that can
be measured with certainty
Reproducibility: The ability to give the same output
for equal inputs applied over some period of time.
1.9 Generalized Static Characteristics
Parameters used to evaluate medical instrument:
Statistical Control: Systematic errors or bias are
tolerable or can be removed by calibration.
Statistical Sensitivity: the ratio of the incremental
output quantity to the incremental input quantity, Gd.

( )( )
( )

=
2
d
2
d
d d
x x n
y x y x n
m
( )( ) ( )( )
( )

=
2
d
2
d
d d
2
d
x x n
x y x x y
b
b mx y + =
d
Finding static sensitivity G
d
using line equation with the
minimal sum of the squared difference between data points
and the line
Figure 1.3 (b) Static sensitivity:
zero drift and sensitivity drift.
Dotted lines indicate that zero
drift and sensitivity drift can be
negative.
Zero Drift: all output values increase or decrease
by the same amount due to manufacturing
misalignment, variation in ambient temperature,
vibration,.
Sensitivity Drift: Output change in proportion to the
magnitude of the input. Change in the slope of the
calibration curve.
Figure 1.4 (a) Basic definition of linearity
for a system or element. The same linear
system or element is shown four times for
different inputs. (b) A graphical illustration
of independent nonlinearity equals A% of
the reading, or B% of full scale, whichever
is greater (that is, whichever permits the
larger error).
x
d
(Input)
B% of full scale
A% of reading
Overall tolerance band
Least-squares
straight line
(a)
(b)
Point at which
A% of reading = B% of full scale
y (Output)
x
1

(x
1
+ x
2
)
y
1
x
2
Kx
1
Ky
1 y
2

Linear
system
Linear
system
Linear
system
Linear
system
and and
(y
1
+ y
2
)
Linearity

Independent nonlinearity
- A% deviation of the reading
- B% deviation of the full scale
Input Ranges (I ):
Minimum resolvable input < I < normal linear operating range
A linear system described by the following equation
y=2x+3. Find the overall tolerance band for the system if
the input range is 0 to 10 and its independent nonlinearity is
0.5% deviation of the full scale and 1.5% deviation of the
reading.
Example
variable flow
iable effort var
d2
d1
= =
X
X
Z
x
2
d2
2
d1
d2 d1
X Z
Z
X
X X P
x
x
= = =
Input Impedance:
disturb the quantity being measured.
X
d1
: desired input (voltage, force, pressure)
X
d2
: implicit input (current, velocity, flow)
P = X
d1
.X
d2
:Power transferred across the tissue-sensor
interface
Generalized input impedance Z
x
Goal: Minimize P, when measuring effort variable X
d1
, by
maximizing Z
x
which in return will minimize the flow
variable X
d2
.
Loading effect is minimized when source impedance Z
s
is
much smaller then the Z
x
) ( ) (
0 1 0 1
t x b
dt
dx
b
dt
x d
b t y a
dt
dy
a
dt
y d
a
m
m
m
n
n
n
+ + + = + + +
( ) ( ) ) ( ) (
0 1 0 1
t x b D b D b t y a D a D a
m
m
n
n
+ + + = + + +
0 1
0 1
) (
) (
a D a D a
b D b D b
D x
D y
n
n
m
m
+ + +
+ + +
=
1.10 Generalized Dynamic Characteristics

Most medical instrument process signals that are functions
of time. The input x(t) is related to the output y(t) by
a
i
and b
i
depend on the physical and electrical parameters
of the system.
Transfer Functions
The output can be predicted for any input (transient,
periodic, or random)
0 1
0 1
) (
) (
a D a D a
b D b D b
D x
D y
n
n
m
m
+ + +
+ + +
=
0 1
0 1
) ( ) (
) ( ) (
) (
) (
) (
a j a j a
b j b j b
j X
j Y
j H
n
n
m
m
+ + +
+ + +
= = e
Frequency Transfer Function
Can be found by replacing D by je
Example:
If x(t) = A
x
sin (e t)
then y(t) = |H(e)| A
x
sin (e t + /_H(e))
Figure 1.5 (a) A linear
potentiometer, an example of a
zero-order system. (b) Linear
static characteristic for this
system. (c) Step response is
proportional to input. (d)
Sinusoidal frequency response
is constant with zero phase
shift.
Zero-Order Instrument
a
0
y(t) = b
0
x(t)
K
a
b
j X
j Y
D x
D y
= = =
0
0
) (
) (
) (
) (
=
K: static sensitivity
First-Order Instrument
) ( ) (
) (
0 0 1
t x b t y a
dt
t dy
a = +
( ) ) ( ) ( 1 D t Kx t y = +
D
K
D x
D y
+
=
1 ) (
) (
( )
( )
( )
( )
( ) 1 / arctan
1
1
2 2


K
j X
j Y
j
K
j X
j Y
=
+
=
+
=
|
0
0
0
1
a
b
K
a
a
= = t
Where t is the time constant
( ) ( )
t /
1
t
e K t y

=
t
1
(c)
(a)
C
+

+

y(t)
Output y(t)
Input x(t)
Slope = K = 1
(b)
Y (je)
X (je)
Log
scale
1.0
0.707
Log scale e
(d)
0
45
90
Log scale e
t
1
0.63
t
L
t
S
t
L
t
S
e
S
e
L
|

t
L
t
S
x(t)
x(t)
y(t)
R
First-Order Instrument
D
K
D x
D y
+
=
1 ) (
) (
( ) ( )
t /
1
t
e K t y

=
Example 1.1: High-pass filter
) ( ) (
) (
t x t y
dt
t dy
RC = +
1 ) ( 1 = = = t x K RC t
Second-Order Instrument
( ) ( )
( ) ( ) t x b t y a
dt
t dy
a
dt
t y d
a
0 0 1
2
2
2
= + +
( ) ( ) t Kx t y

D
n n
=
(

+ + 1
2
2
2
units input by defined units output y, sensitivit static
0
0
= =
a
b
K
rad/s frequency, natural undamped
2
0
= =
a
a

n
ess dimensionl ratio, damping
2

2 0
1
= =
a a
a
( )
( )
1
2
2
2
+ +
=
n n

D

D
K
D x
D y
Operational Transfer Function
( )
( ) ( ) ( )
( )
( )
( ) | |



K
j X
j Y
j j
K
j X
j Y
n n
n n
n n
/ /
2
arctan
/ 4 / 1
1 / 2 /
2 2 2
2
2
2

=
+
=
+ +
=
|
Frequency Transfer Function
Many medical instrument are 2
nd
order or higher
Figure 1.7 (a) Force-measuring
spring scale, an example of a
second-order instrument. (b)
Static sensitivity.
Output y ( t )
(b)
(d) (c)
1
K
s
x(t)
y(t)
y
n
y
n + 1
Resonance
2
Log
scale
1
2
-90
0.5
1
2
-180
1
0.5
0.5
Log scale e

Log scale e

K
1
t
t
Input x(t)
Slope K =
1
K
s

0
e
n
e
n
Y (je)
X (je)
|

Output
displacement
(a)
Input
Force x(t)
0
y(t)
2
nd
order mechanical force-measuring Instrument
( )
( )
( )
( )
2
2
dt
t y d
M t y K
dt
t dy
B t x
s
=
s
K K / 1 =
M
K

s
n
=
M K
B

s
2
=
B = viscosity constant
K
s
= spring constant
Natural freq.
Damping ratio
(c) Step response for overdamped case , = 2, critically damped case , = 1,
underdamped case , = 0.5.
(d) Sinusoidal steady-state frequency response, , = 2, , = 1, , = 0.5.
: 1 >
( ) K Ke

Ke

t y
t t
n n
+

+
=
|
.
|

\
|
|
.
|

\
|
+ 1
2
2
1
2
2
2 2
1 2
1
1 2
1
: 1 =
( ) ( ) K Ke t t y
t
n
n
+ + =

1
: 1 <
( ) ( )
2
2
2
1 arcsin
1 sin
1

K t K

e
t y
n
t
n
=
+ +

=

|
|
Overdamped
Underdamped
Critically damped
1
K
s
y(t)
0.5
t
2
1 , e e =
n d
Damped natural freq.
2
1
2 / 3

t
n
n

=
|
2
1
1
2 / 7

t
n
n

=
+
|
( )
( )
2
1
2
2 2
2
2
1
1
2
ln
1
2
exp
1
2 / 7
exp
1
1
2 / 3
exp
1

y
y

K
y
y
n
n
n
n
n
n
n
n

= A =
|
|
.
|

\
|
|
|
.
|

\
|

=
|
|
.
|

\
|

(
(

|
|
.
|

\
|

|
|
|
.
|

\
|

(
(

|
|
.
|

\
|

=
+
+
|
|
2 2
4 A +
A
=

and
Example 1.2: for underdamped second-order instruments,
find the damping ratio from the step response
Logarithmic decrement
( ) ( ) K t K

e
t y
n
t
n
+ +

=

|
2
2
1 sin
1
( ) ( )
d
t Kx t y =
d
t >
( )
( )
d
j
Ke
j X
j Y
t
=
Time Delay System
Log
scale
Log scale e

Log scale e

K
0
Y (je)
X (je)
|

d

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.
Design Criteria
Commercial Medical Instrumentation
Development Process
Ideas: come from people working in the health care
Detailed evaluation and signed disclosure
Feasibility analysis and product description
Medical need
Technical feasibility
Brief business plan (financial, sales, patents, standards, competition)
Product Specification (interface, size, weight, color)
What is required but nothing about how
Design and development (software and hardware)
Commercial Medical Instrumentation
Development Process
Prototype development
Testing on animals or human subjects
Final design review (test results for, specifications, subject feedback,
cost)
Production (packaging, manual and documents)
Technical support
Regulation of Medical Devices
Medical devices is any item promoted for a medical
purpose that does not rely on chemical action to achieve its
intended effect

2 Ways for Medical Devices Classification
First Way: (based on potential hazards)
Class I: general controls
Class II: performance standards
Class III: premarketing approval
Second Method: (see Table 1.2 in textbook)
preamendment, postamendment, substantially equivalent,
implant, custom, investigational, transitional
Regulation of Medical Devices
Second Way of classifications: (see Table 1.2 in textbook)
Preamendment: Devices on the market before 5/28/1976
Postamendment: Devices on the market after 5/28/1976
Substantially equivalent: Equivalent to preamendment
devices
Implant: devices inserted in human body and intended to
remain there for >30 days.
Custom: Devices not available to other licensed and not in
finished form
Investigational: Unapproved devices undergoing clinical
investigation
Transitional: devices that were regulated as drugs and now
defined as medical devices