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http://ejwoo.com 1 Eung Je Woo
Dept. of Biomed. Eng. BME302: Biomedical Instrumentation Kyung Hee Univ.
Control
And
feedback
Power
Sensor source
Perceptible
Primary Variable Signal output
Output
Measurand Sensing Conversion processing display
element element
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.
Measurand
Physical quantity, property, or condition that the system measures
Accessibility: internal, body surface, emanation from the body, or tissue sample
Category: biopotential, pressure, flow, dimensions, displacement, impedance,
temperature, and chemical concentration
Localization: organ or anatomical structure
Sensor
Transducer (sensor) is a device that converts one form of energy to another (electric)
Specific
Minimization of the extracted energy
Minimally invasive
Primary sensing element and variable conversion element
Signal Conditioning
Amplification, filtering, impedance matching, A/C conversion, DSP, etc.
http://ejwoo.com 2 Eung Je Woo
Dept. of Biomed. Eng. BME302: Biomedical Instrumentation Kyung Hee Univ.
Output Display
Visual sense
Numerical or graphical
Discrete or continuous
Permanent or temporary
Auditory sense
Tactile sense
Human factors engineering guidelines and preferred practices for the design of
medical devices (AAMI, 1993)
Auxiliary Elements
Calibration
Control and feedback
Storage
Transmission
Direct-Indirect Modes
Accessible (noninvasive or invasive) direct mode
Not accessible indirect mode
Cardiac output (CO) by Fick method, dye dilution, or thermodilution
Morphology of internal organs by X-ray shadows
Pulmonary volumes by thoracic impedance plethysmography
http://ejwoo.com 3 Eung Je Woo
Dept. of Biomed. Eng. BME302: Biomedical Instrumentation Kyung Hee Univ.
photoconductive cell
http://ejwoo.com 4 Eung Je Woo
Dept. of Biomed. Eng. BME302: Biomedical Instrumentation Kyung Hee Univ.
Electrodes
vecg
Z1 60-Hz +Vcc
ac magnetic
Zbody
Z2 field
+
Differential
amplifier
vo
Displacement
currents Vcc
http://ejwoo.com 5 Eung Je Woo
Dept. of Biomed. Eng. BME302: Biomedical Instrumentation Kyung Hee Univ.
Inherent Insensitivity
Make all components inherently sensitive only to desired inputs
Twisting the lead wires in Fig. 1.2
Use Ag/AgCl electrode to reduce motion artifact
Negative Feedback
xd H f y Gd y y
Gd
1 H f Gd
xd
1
If H f Gd 1 , y xd
Hf
Advantages: less power, more accurate and linear, less loading
Disadvantages: possible oscillation
Signal Filtering
A filter is "a device or program that separates data, signals, or material in accordance
with specific criteria" (a filter usually separates signals according to their frequencies)
Electrical, mechanical, pneumatic, thermal, or electromagnetic filters
Filters at input, intermediate, and output stage
Opposing Inputs
Use additional interfering inputs to cancel undesired output due to interfering and/or
modifying inputs
Opposing inputs before or after the appearance of undesired signals
1.8 Biostatistics
Application of statistics
Design experiments or clinical studies
http://ejwoo.com 6 Eung Je Woo
Dept. of Biomed. Eng. BME302: Biomedical Instrumentation Kyung Hee Univ.
http://ejwoo.com 7 Eung Je Woo
Dept. of Biomed. Eng. BME302: Biomedical Instrumentation Kyung Hee Univ.
Interquartile range
Standard error of the mean, SEM
Relationship between two variables
Correlation coefficient
Inference
Estimation
Confidence interval
Hypothesis testing
Null-hypothesis
P-value
Accuracy
Sensitivity
Specificity
Prior probability
Optimal decision: decision analysis such as decision tree analysis
Accuracy
truevalue measuredvalue
Accuracy 100(%)
truevalue
Measure of the total error
True or reference value: NIST (National Institute of Standards and Technology)
Varies with the normal range and frequency of inputs
Expressions
% of reading
% of FS (or simply %)
number of digits
1
the smallest division of an analog scale
2
Sum of the above
http://ejwoo.com 8 Eung Je Woo
Dept. of Biomed. Eng. BME302: Biomedical Instrumentation Kyung Hee Univ.
Precision
Number of distinguishable alternatives from which a given result is selected
High precision does not necessarily implies high accuracy
Resolution
Smallest incremental quantity that can be measured with certainty
Degree to which nearly equal two values of a quantity can be discriminated
Same as threshold when it starts from zero
Reproducibility or repeatability
Ability to give the same output for equal inputs applied over some period of time
Reproducibility does not imply accuracy
Statistical Control
Random variations in measurements statistical analysis determine error
variation
Averaging can improve the estimate of the true value
Static Sensitivity
Static calibration
Hold all inputs constant except one
Increase the input over the normal operating range and measure the output
incrementaloutput
Static sensitivity =
incrementalinput
Zero Drift
All output values increase or decrease by the same absolute amount (Fig. 1.3(b))
Causes
Manufacturing misalignment
Variations in ambient temperature
Hysteresis
Vibration
http://ejwoo.com 9 Eung Je Woo
Dept. of Biomed. Eng. BME302: Biomedical Instrumentation Kyung Hee Univ.
Shock
Sensitivity to forces from undesired direction
Example: slow changes of dc offset voltage of ECG electrodes
Sensitivity Drift
Changes in the slope of the calibration curve (Fig. 1.3(b))
Error is proportional to the magnitude of input
Causes
Manufacturing tolerance
Variations in power supply
Nonlinearities
Change in ambient temperature and pressure
Example: variations of ECG amplifier gain due to the fluctuation of dc power supply
voltage or temperature
Linearity
Requirements: Fig. 1.4(a), K1 x1 K 2 x2 LinearSystem K1 y1 K 2 y2
High accuracy does not necessarily implies linearity
Independent nonlinearity
Measure of deviation from linearity
A% of reading or B% of full scale, whichever is greater (Fig. 1.4(b))
Equal to the accuracy of a linear instrument if other sources of error are minimal
and and
x2 y2 Kx1 Ky1
Linear Linear
system system
(a)
Figure 1.4 (a) Basic definition of linearity
for a system or element. The same linear
Least-squares
system or element is shown four times for straight line
different inputs. (b) A graphical illustration y (Output)
of independent nonlinearity equals A% of B% of full scale
the reading, or B% of full scale, whichever
A% of reading
is greater (that is, whichever permits the
larger error). [Part (b) modified from
Measurement Systems: Application and
Design, by E. O. Doebelin. Copyright
1990 by McGraw-Hill, Inc. Used with
permission of McGraw-Hill Book Co.] Overall tolerance band
xd (Input)
Point at which
A% of reading = B% of full scale
(b)
Input Ranges
Input Impedance
X d1
Input impedance, Z x
Xd2
force, pressure)
velocity, flow)
X d21
Power, P X d 1 X d 2 Z x X d22
Zx
Instantaneous rate at which energy is transferred across the tissue-sensor interface
measuring X d 1
Loading effect
a D
n
n
a1 D a0 y (t ) bm D m b1 D b0 x(t )
Transfer Functions
Operational transfer function
y ( D) bm D m b1 D b0
H ( D)
x( D ) an D n a1 D a0
Useful for transient inputs
Frequency transfer function
Y ( j ) bm j b1 j b0
m
H ( j )
X ( j ) an j n a1 j a0
Zero-Order Instrument
y ( D) y ( j ) b0
a0 y(t ) b0 x(t ) and K static sensitivity
x( D) x( j ) a0
No amplitude and phase distortion
Linear potentiometer at low frequency and small load (Fig. 1.5)
First-Order Instrument
dy (t )
a1 a0 y (t ) b0 x(t ) or ( D 1) y (t ) Kx(t )
dt
b
K 0 static sensitivity
a0
a1
time constant
a0
y ( D) K Y ( j ) K K 1
and arctan
x( D) 1 D X ( j ) 1 j 1 j 2 2
dy
RC LPF in Fig. 1.6 with RC y (t ) Kx(t )
dt
y (t ) K 1 e t
y (t ) Ket
Y ( j ) j
X ( j ) 1 j
Output y(t)
+ +
C Slope = K = 1
x(t) y(t)
Figure 1.6 (a) A low-pass RC Input x(t)
filter, an example of a first- (a) (b)
y(t)
1 0°
S Log scale
0.63 L
45°
90°
S L t
Second-Order Instrument
d 2 y (t ) dy (t ) D 2 2 D
a2 a a y (t ) b x (t ) or 2 1 y (t ) Kx(t )
n n
1 0 0
dt 2 dt
b0
K static sensitivity , output units divided by input units
a0
a0
n undamped natural frequency, rad/s
a2
a1
damping ratio, dimensionless
2 a0 a2
y ( D) K
and
x( D) D 2 2 D
1
n2 n
Y ( j ) K
X ( j ) j n 2 j n 1
2
K 2
arctan
n n
2
1 n 2 4 2 2 n2
Step response of the mechanical force-measuring instrument in Fig. 1.7
Overdamped, 1 :
y (t )
2 1
Ke
1 t
2
n 2 1
Ke
1 t K
2
n
2 12
2 1
2
Underdamped, 1 :
y (t )
e nt
1 2
K sin
1 2 n t K and arcsin 1 2 and
Damping ratio of 0.7: practical compromise between rapid rise time and minimal
overshoot
3 2 7 2
In Fig. 1.7(c), for 0.3 , tn and tn 1
n 1 2
n 1 2
yn 2 y 2
exp , logarithmic increment ln n and
yn 1 1
2
y 1 2
n 1
4 22
Output Input
displacement Force x(t)
0
Figure 1.7 (a) Force-measuring y(t)
Output y(t)
spring scale, an example of a
second-order instrument. (b)
1
Static sensitivity. (c) Step Slope K =
Ks
response for overdamped case
= 2, critically damped case (a) (b)
Input x(t)
Y (j
= 1, underdamped case = 0.5. x(t)
Log
Resonance
scale X (j
(d) Sinusoidal steady-state 1 K
frequency response, = 2, = 1, 2
1
0.5
Time Delay
Y ( j )
y (t ) Kx(t d ), t d and Ke j d
X ( j )
Time-delay element, analog delay line, transport lag, or dead time
Negative phase angle time delay
Varying phase with frequency varying time delay with frequency
Y ( j )
Undistorted signal reproduction with time delay K d
X ( j )
Overall instrument transfer function
Ensure the safety and efficacy of new medical devices prior to marketing of the
device
Medical device is "any item promoted for a medical purpose that does not rely on
chemical action to achieve its intended effect."
First classification
Class I general control
Class II performance standards
Class III premarket approval
Second classification (Table 1.2)
Preamendment
Postamendment
Substantially equivalent
Implant
Custom
Investigational
Transitional