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Chapter 1-Webster Basic Concepts of Medical Instrumentation

Generalized instrumentation system


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 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


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
pressure displacement diaphragm Strain gage 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.

1.6 Interfering and Modifying Inputs


Electrodes

vecg
Z1 Z2 Zbody

60-Hz ac magnetic field +

+Vcc

Differential amplifier 

vo

Displacement currents

Vcc

Desired input: Electrocardiographic voltage Vecg Interfering input: voltage due to 60-Hz
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. Z1 and Z2 represent the electrode-skin interface impedances.

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 Gd which is effected by the modifying inputs
(xd Hfy)Gd = y xdGd = y(1 + HfGd) (1.1) (1.2) (1.3)

Gd y! xd 1  H f Gd

Signal Filtering (electric, mechanical, magnetic) Opposing Inputs

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

Statistical Measurements
Measures of the mean and central tendency -Mean X X !
i

-Median: Middle value (used for skewed data) -Mode: is the observation that occurs most frequently -Geometric Mean: used with data on a logarithmic scale
GM ! n X 1 X 2 X 3 X n

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 2
s!

X

n 1

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.
s CV ! X 100 %

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
r!

X X
i

 X Yi  Y
2 i

X

Y Y

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.

Finding static sensitivity Gd using line equation with the minimal sum of the squared difference between data points and the line

y ! mx d  b

m!

n xd y  xd y n x  xd
2 d 2

y x  x y x b! n x  x
2 d d d 2 d 2 d

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 1.3 (b) Static sensitivity: zero drift and sensitivity drift. Dotted lines indicate that zero drift and sensitivity drift can be negative.

Linearity Independent nonlinearity

x1

Linear system and

y1

(x1 + x2)

Linear system and

(y1 + y2)

x2

Linear system

y2
(a)

Kx1

Linear system

Ky1

- A% deviation of the reading - B% deviation of the full scale


y (Output)

Least-squares straight line B% of full scale A% of reading

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 sA% of the reading, or sB% of full scale, whichever is greater (that is, whichever permits the larger error).

Overall tolerance band

xd (Input) Point at which A% of reading = B% of full scale (b)

Input Ranges (I):

Minimum resolvable input < I < normal linear operating range

Example
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.

Input Impedance:
disturb the quantity being measured. Xd1 : desired input (voltage, force, pressure) Xd2 : implicit input (current, velocity, flow) P = Xd1.Xd2 :Power transferred across the tissue-sensor interface Generalized input impedance Zx
X d1 effort variable Zx ! ! X d2 flow variable

P ! X d1 X d2

X 2 ! ! Z x X d2 Zx

2 d1

Goal: Minimize P, when measuring effort variable Xd1, by maximizing Zx which in return will minimize the flow variable Xd2. Loading effect is minimized when source impedance Zs is much smaller then the Zx

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
dny dy dmx dx a n n   a1  a 0 y (t ) ! bm m   b1  b0 x(t ) dt dt dt dt

ai and bi depend on the physical and electrical parameters of the system.

a D
n

  a1 D  a 0 y (t ) ! bm D m   b1 D  b0 x(t )

Transfer Functions
The output can be predicted for any input (transient, periodic, or random) m
y ( D ) bm D   b1 D  b0 ! x( D) a n D n   a1 D  a0

Frequency Transfer Function


Can be found by replacing D by j[

y ( D ) bm D   b1 D  b0 ! x( D ) a n D n   a1 D  a 0
m

Y ( j ) bm ( j ) m   b1 ( j )  b0 ! H ( j[ ) ! X ( j ) an ( j ) n   a1 ( j )  a0

Example:
If then x(t) = Ax sin ([ t) y(t) = |H([)| Ax sin ([ t + /_H([))

Zero-Order Instrument a0 y(t) = b0 x(t)


y ( D ) Y ( j ) b0 ! ! !K x ( D ) X ( jZ ) a0

K: static sensitivity
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.

First-Order Instrument
dy (t ) a1  a 0 y (t ) ! b0 x(t ) dt

D  1 y (t ) ! Kx(t )
a1 X ! a0
y ( D) K ! x( D ) 1  D Y j X j

y t ! K 1  e  t / X

b0 K ! a0

Where X is the time constant

! K 1 j Y j K ! X j 1 2

J ! arctan 

/1

First-Order Instrument
Output y(t) R

dy (t ) RC  y (t ) ! x (t ) dt
X ! RC K ! 1 x (t ) ! 1

x(t)


y(t)


Slope = K = 1

Input x(t) (a) (b) x(t) Log scale Y (j[ X (j[

y ( D) K ! x( D ) 1  D
1

y t ! K 1  e

t / X


t (c) y(t)

1.0 0.707 XL [L
(d)

XS

[S

Log scale [

1 0.63

0  45 90 t XL

XS

Log scale [

XS

XL

Example 1.1: High-pass filter

Second-Order Instrument
Many medical instrument are 2nd order or higher
a2 d y t dy t  a1  a 0 y t ! b0 x t 2 dt dt
2

D2 2 D  1 y t ! Kx t 2  n n

b0 K! ! static sensitivity, output units defined by input units a0


n

a0 ! undamped natural requency, rad/s a2

a1 2 a0 a2

! damping ratio, dimensionl ess

Operational Transfer Function Frequency Transfer Function


Y j X j

y D ! 2 x D D
2 n

K 2 D
n

1

! K j / n 2  2 j / n  1 Y j K ! 2 2 X j 1 ? / A  4 2 2 /
n

J ! arctan
2 n

2 / n

2nd order mechanical force-measuring Instrument


dy t d 2 y t x t  B  K s y t ! M dt dt 2
Output Input displacement Force x(t)
0

B = viscosity constant Ks = spring constant

y(t)
Output y(t)

K ! 1/ K s
(a)

Slope K =

Ks Input x(t) Resonance

Ks M

(b)

Natural freq.
1

x(t)

B ! 2 KsM

Y (j[ Log scale X (j[ K 2

0.5 1 [n Log scale [

Damping ratio
(c) y(t) yn
n+1

t (d) J

Log scale [ 0 Figure 1.7 (a) Force-measuring y 0.5 2 1 1 spring scale, an example of a K -90 second-order instrument. (b) 0.5 1 2 -180 Static sensitivity. t (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.
s

[n

Overdamped
y t !   2
2 2

" 1:

1

Ke

 

1

nt

 2
2

1

Ke

 

1

nt

K

1

1

Critically damped

! 1:

nt

y t !   1
Underdamped
y t !  e 1 J ! arcsin 1 
nt

t Ke

K

1:
K sin 1 
2

2 n

t J  K
1 Ks 0.5

y(t)

[ d ! [ n 1  ^ 2 Damped natural freq.

Example 1.2: for underdamped second-order instruments, find the damping ratio from the step response
y t !  e 1
nt

K sin 1 

2 n

t J  K

tn !

3 / 2 J
n

and

1

t n 1 !

7 / 2 J
n

1

yn ! yn 1 K 1 2 ! exp 1

K 1

exp  exp 

3 / 2  J n 2 n 1  7 / 2  J n 2 n 1 

yn 2 !0! ln y 1 n 1

!
2

0 4
2

 02

Logarithmic decrement

Time Delay System


y t ! Kx t 
Y j X j
d

t"
Log scale K

d
Y (j[ X (j[

! Ke  j

Xd

Log scale [
J
0

Log scale [

Design Criteria

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.

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

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