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Biomedical

Instrumentation

Biomedical Instrumentation Winter 1393 Bonab University

Winter 1393 Bonab University

Biomedical Instrumentation Winter 1393 Bonab University
Biomedical Instrumentation Winter 1393 Bonab University
Biomedical Instrumentation Winter 1393 Bonab University

Course information

Course information Prerequisites: • Electronic Measurements Recommended Books and Notes: Intro • J.G. Webster,

Prerequisites:

• Electronic Measurements

Recommended Books and Notes:

Intro

Electronic Measurements Recommended Books and Notes: Intro • J.G. Webster, “Medical Instrumentation Application and

• J.G. Webster, “Medical Instrumentation Application and Design”, John Wiley & Sons, 2010

• J. Aston, “Principles of Biomedical Instrumentation and Measurement”, Merrill Publishing

Company, 1990. • J.D. Enderle, J.D.Bronzino, “Introduction to Biomedical Engineering”, Wiley, 3 rd Ed. 2008

Tentative Grading:

Project (including in-class presentation)

35%

Oral Presentation in class

20%

Review paper (2-3 pages, IEEE conference format) 15%

 

Final Exam

65%

The main Course book

Intro

J.G. Webster, “Medical Instrumentation Application and Design”, John Wiley & Sons, 4 th ED., 2010
J.G. Webster, “Medical
Instrumentation Application and
Design”, John Wiley & Sons, 4 th
ED., 2010
Describes:
-principles
-applications
-design
Medical instruments commonly
Used in hospitals
Just fundamentals (details
change with time)
3

About John G Webster’s book

About John G Webster’s book Intro 4

Intro

About John G Webster’s book Intro 4
About John G Webster’s book Intro 4
About John G Webster’s book Intro 4
About John G Webster’s book Intro 4
About John G Webster’s book Intro 4
About John G Webster’s book Intro 4
About John G Webster’s book Intro 4
About John G Webster’s book Intro 4
About John G Webster’s book Intro 4
About John G Webster’s book Intro 4
About John G Webster’s book Intro 4
About John G Webster’s book Intro 4

ترازو بوصم لصفرس

5
5

Intro

ترازو بوصم لصفرس 5 Intro

Examples: Cochlear Implant

Examples: Cochlear Implant Intro • A surgically implanted electronic device that provides a sense of sound

Intro

Examples: Cochlear Implant Intro • A surgically implanted electronic device that provides a sense of sound

A surgically implanted electronic device that provides a sense of sound to a person who is profoundly deaf

The quality of sound is different from natural hearing, with less sound information

Each sensory fiber of the cochlear nerve handles a specific frequency (electively sensitive to a very narrow

frequency band)

stimulate all fibers

Examples: Advances in Vision (Retinal Stimulation)

Intro

• A retinal implant is a biomedical implant technology currently being developed • Meant to
• A retinal implant is a biomedical implant
technology currently being developed
• Meant to partially restore useful vision to
people who have lost their vision due to
degenerative eye conditions
• Provide the user with low resolution images
by electrically stimulating surviving retinal
cells
• Sufficient for restoring specific visual
abilities, such as light perception and
object recognition

Examples: Mini Gastric Imaging

Examples: Mini Gastric Imaging Intro • It is considered to be a very safe method to

Intro

Examples: Mini Gastric Imaging Intro • It is considered to be a very safe method to

It is considered to be a very safe method to determine an unknown cause of a gastrointestinal bleed

to examine parts of the gastrointestinal tract that cannot be seen with other types of endoscopy

capsule usually passes through feces within 2448 hours

tract that cannot be seen with other types of endoscopy • capsule usually passes through feces
tract that cannot be seen with other types of endoscopy • capsule usually passes through feces

A success story: The AutoAnalyzer (Technicon, 35 years)

A success story: The AutoAnalyzer (Technicon, 35 years) CH-1 • New medical instrument:

CH-1

A success story: The AutoAnalyzer (Technicon, 35 years) CH-1 • New medical instrument:

New medical instrument: invention-prototype-development-clinical testing- regulatory approval-manufacturing-marketing-sale of new instrument

An automated analyzer using a flow technique called continuous flow analysis (CFA)

The design is based on separating a continuously flowing stream with air bubbles

A continuous stream of material is divided by air bubbles into discrete segments in

which chemical reactions occur

Was used: determine levels of albumin, alkaline phosphatase, blood urea nitrogen, bilirubin, calcium, cholesterol,but now is replaced by discrete systems

cholesterol, … but now is replaced by discrete systems • Now mainly in industrial processes: Water,

Now mainly in industrial processes: Water, soil extracts

9

Generalized Medical instrumentation system

CH-1

Generalized Medical instrumentation system CH-1 Control feedback And Power source Sensor Primary Sensing

Control

feedback

And Power source Sensor
And
Power
source
Sensor

Primary

Sensing

element

Measurand
Measurand
source Sensor Primary Sensing element Measurand Calibration signal Radiation, electric current, or

Calibration

signal

Radiation,

electric current,

or other applied energy

Radiation, electric current, or other applied energy Perceptible output Output display Variable Conversion
Perceptible output Output display
Perceptible
output
Output
display
Variable Conversion element
Variable
Conversion
element
Signal processing Data
Signal
processing
Data

storage

Conversion element Signal processing Data storage Data transmission Figure 1.1 The sensor converts energy

Data

transmission

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

Measurand (quantity the system measures): Physical quantity

CH-1

• Measurand accessibility: • Internal (blood pressure), on the body surface (electrocardiogram potential), emanate
• Measurand accessibility:
• Internal (blood pressure), on the body surface
(electrocardiogram potential), emanate from body
(infrared radiation), derived from a sample (blood, biopsy)
• Biopotential
• Pressure
• Flow
• Dimensions (imaging)

Displacement (velocity, acceleration, force)

Impedance

Temperature

Chemical Concentration

11

(imaging) • Displacement (velocity, acceleration, force) • Impedance • Temperature • Chemical Concentration 11
(imaging) • Displacement (velocity, acceleration, force) • Impedance • Temperature • Chemical Concentration 11

Sensor and Transducer

CH-1

• Transducer • Converts one form of energy to another • Sensor • Converts a
• 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

electric voltage

Strain gage

diaphragm

energy extracted • Minimally invasive pressure displacement electric voltage Strain gage diaphragm Pulse Oximetry 12
energy extracted • Minimally invasive pressure displacement electric voltage Strain gage diaphragm Pulse Oximetry 12
energy extracted • Minimally invasive pressure displacement electric voltage Strain gage diaphragm Pulse Oximetry 12

Pulse Oximetry

Signal Conditioning

CH-1

• Amplification • Filtering
• Amplification
• Filtering

Impedance matching

• Amplification • Filtering • Impedance matching • Analog/Digital for signal processing • Signal form

Analog/Digital for signal processing

Signal form (time and frequency domains)

• Impedance matching • Analog/Digital for signal processing • Signal form (time and frequency domains) 13
• Impedance matching • Analog/Digital for signal processing • Signal form (time and frequency domains) 13

Output Display

CH-1

Output Display CH-1 • Numerical Beeps • Graphical • Discrete or continuous • Visual • Hearing

Numerical

Beeps
Beeps

Graphical

Discrete or continuous

Output Display CH-1 • Numerical Beeps • Graphical • Discrete or continuous • Visual • Hearing

Visual

Hearing

14

Auxiliary Element

CH-1

• Calibration Signal (as early in signal processing chain as possible) • Control and Feedback
• Calibration Signal (as early in signal processing chain
as possible)
• Control and Feedback (auto or manual)

Adjust sensor and signal conditioning

15

processing chain as possible) • Control and Feedback (auto or manual) • Adjust sensor and signal
processing chain as possible) • Control and Feedback (auto or manual) • Adjust sensor and signal

1.3 Alternative Operational Modes

1.3 Alternative Operational Modes CH-1 • Direct Mode: Measurand is readily accessible • Temperature • Heart

CH-1

1.3 Alternative Operational Modes CH-1 • Direct Mode: Measurand is readily accessible • Temperature • Heart

Direct Mode: Measurand is readily accessible

Temperature

Heart Beat

Indirect Mode: desired measurand is measured by measuring accessible measurand.

16

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

(Breathing out = Low impedance)

and blood gas concentration • Pulmonary volumes: variation in thoracic impedance (Breathing out = Low impedance)

1.3 Sampling and Continuous Modes

1.3 Sampling and Continuous Modes CH-1 • Sampling and collecting data will depend on the following:

CH-1

1.3 Sampling and Continuous Modes CH-1 • Sampling and collecting data will depend on the following:

Sampling and collecting data will depend on the following:

The rate of change in the measurand (temp., ion concentration = slow

sampling

vs. ECG or respiratory gas continuous)

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)

of energy from an external source (Photoconductive cell) • Analog and Digital Modes • Real-Time and

Analog and Digital Modes

Real-Time and Delayed-Time Modes

17

1.4 Medical Measurement Constraints

1.4 Medical Measurement Constraints CH-1 • Magnitude and frequency range of medical measurand are very low

CH-1

1.4 Medical Measurement Constraints CH-1 • Magnitude and frequency range of medical measurand are very low

Magnitude and frequency range of medical measurand are very low

Proper measurand-sensor interface cannot be obtained (without damage)

Medical variables are seldom deterministic

External energy must be minimized to avoid any damage

Equipment must be reliable

are seldom deterministic • External energy must be minimized to avoid any damage • Equipment must

18

Ballistocardiograph

CH-1

Ballistocardiograph CH-1 19 A person lies down on a flat board set on rollers. A laser
Ballistocardiograph CH-1 19 A person lies down on a flat board set on rollers. A laser

19

Ballistocardiograph CH-1 19 A person lies down on a flat board set on rollers. A laser

A person lies down on a flat board set on rollers. A laser beam is directed at a tiny mirror positioned on one of the rollers. The laser beam is projected onto the ceiling or wall. The beating of the person's heart causes a slight movement in the body as indicated by the laser. This upward movement of the body is due to the 3rd Law reaction force of the blood being pumped to the lower body. The left ventricle of the heart squeezes blood upward into the aorta shown below. At the peak of the contraction, about 80 grams of blood is moving upward at 30 cm/s. The aorta does a U-turn forcing most of the blood to flow down to the lower body. The aorta and body force the blood down and in turn the body is forced up. The amount is too small to be seen by eye but can be seen when "amplified" by the laser-mirror arrangement used in the demonstration. It can also be seen when standing quietly on a weight scale if the scale is sensitive enough and the vibration is not damped by the scale mechanism. Your weight decreases slightly when the blood slams into the top of the aorta.

is not damped by the scale mechanism. Your weight decreases slightly when the blood slams into

1.5 Classification of Medical Instrument

1.5 Classification of Medical Instrument • Quantity that is sensed • pressure, flow, temp • Principle

Quantity that is sensed

pressure, flow, temp

Principle of transduction

resistive, capacitive, electrochemical, ultrasound

resistive, capacitive, electrochemical, ultrasound • • Organ system • Cardiovascular • Pulmonary •

Organ system

Cardiovascular

Pulmonary

Nervous

Organ system • Cardiovascular • Pulmonary • Nervous • Medicine specialties • pediatrics, cardiology,

Medicine specialties

pediatrics, cardiology, radiology

20

• Cardiovascular • Pulmonary • Nervous • Medicine specialties • pediatrics, cardiology, radiology 20 CH-1
• Cardiovascular • Pulmonary • Nervous • Medicine specialties • pediatrics, cardiology, radiology 20 CH-1
• Cardiovascular • Pulmonary • Nervous • Medicine specialties • pediatrics, cardiology, radiology 20 CH-1

CH-1

• Cardiovascular • Pulmonary • Nervous • Medicine specialties • pediatrics, cardiology, radiology 20 CH-1

1.6 Interfering and Modifying Inputs

CH-1

• Desired Inputs: measurands that the instrument is designed to isolate. • Interfering Inputs: quantities
• 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.

by altering the performance of the instrument itself. Effect of a burst or ESD ( Electrostatic

Effect of a burst or ESD (Electrostatic discharge) disturbance on an electronic board.

1.6 Interfering and Modifying Inputs CH-1 Electrodes v ecg 60-Hz +V cc Z 1 ac
1.6 Interfering and Modifying Inputs
CH-1
Electrodes
v
ecg
60-Hz
+V cc
Z
1
ac magnetic
Z
body
field
Z
2
+
Differential
amplifier
v
o
-
Displacement
currents
-V cc
Desired input: Electrocardiographic voltage V ecg
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. Z 1 and
represent the electrode-skin interface impedances.
Z
2

1.7 Compensation Techniques

1.7 Compensation Techniques To eliminate interfering and modifying input: CH-1 1.Alter the design of essential instrument

To eliminate interfering and modifying input:

CH-1

To eliminate interfering and modifying input: CH-1 1.Alter the design of essential instrument components to be

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.

The four electromagnetic

interference (EMI)

coupling modes

new components designed to offset the undesired inputs. The four electromagnetic interference (EMI) coupling modes 23

1.7 Compensation Techniques

1.7 Compensation Techniques CH-1 • Inherent Insensitive ( twist electrode wires in ECG) • Negative Feedback

CH-1

1.7 Compensation Techniques CH-1 • Inherent Insensitive ( twist electrode wires in ECG) • Negative Feedback

Inherent Insensitive (twist electrode wires in ECG)

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)

y

G

d

x d
x
d

1 H G

f

d

) (1.2) • y  G d x d 1  H G f d (1.3)

(1.3)

Signal Filtering (electric, mechanical, magnetic)

At the input, output, inside the device (many designers use non-electric at input)

Opposing Inputs (additional interfering inputs to cancel undesired)

Compensation Techniques- Example

CH-1

An amplifier with gain 10 that has 20% fluctuation due to temperature and environmental change.
An amplifier with gain 10 that has 20%
fluctuation due to temperature and
environmental change. How to compensate the
system to minimize the fluctuation?

Solution: (say, for when gain decreases by 20%)

25

Use a thermistor (temperature dependent resistor)

Adjust characteristics of active system elements (say, amplification factor)

(temperature dependent resistor) • Adjust characteristics of active system elements (say, amplification factor)
(temperature dependent resistor) • Adjust characteristics of active system elements (say, amplification factor)

1.8 Biostatistics

CH-1

• Applications of Statistics to medical data - Design experiment - Clinical Study: summarize, explore,
• 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

Medical Research Studies CH-1 • - Observational : Characteristics of patients are observed and recorded -

CH-1

Medical Research Studies CH-1 • - Observational : Characteristics of patients are observed and recorded -

- 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 (1 particular time)

- 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: Patients random to treatments and investigator does not know which

Statistical Measurements

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

Measures of the mean and central tendency

- Mean

X

i

X

n

CH-1

the mean and central tendency - Mean  X i X  n CH-1 - Median

- 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
n

X X X

1

2

3

 X

n

occurs most frequently - Geometric Mean : used with data on a logarithmic scale GM 

Statistical Measurements

Statistical Measurements CH-1 Measure of spread or dispersion of data • Range : Difference between the

CH-1

Statistical Measurements CH-1 Measure of spread or dispersion of data • Range : Difference between the

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

s

2   X - X   i n - 1
2
X
-
X
 
i
n
- 1
about the mean s 2   X - X   i 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 100%

X

CV  

the variation to compare data measured in different scales.  s   100%  

Statistical Measurements

CH-1

• Percentile: gives the percentage of a distribution that is less than or equal to
• 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

X
-
X
Y
-
Y
i
i
r 
2
2
X
-
X
Y
-
Y
i
i

Methods for inference

CH-1

Methods for inference about a value in a population of subjects from a set of
Methods for inference about a value in a
population of subjects from a set of
observations.
• Estimation and confidence interval:
of observations. • Estimation and confidence interval: are used to estimate specific parameters such as the

are used to estimate specific parameters such as the mean and the variance.

specific parameters such as the mean and the variance. • Hypothesis testing and P-value : reveals

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

Methods for measuring the accuracy of a diagnostic procedure • Sensitivity of a test : Probability

Sensitivity of a test:

Probability of its yielding positive results in patients who actually

have the disease.

results in patients who actually have the disease. CH-1 • Specificity of a test : Probability

CH-1

results in patients who actually have the disease. CH-1 • Specificity of a test : Probability

Specificity of a test:

Probability of its yielding negative results in patients who do not have the disease

negative results in patients who do not have the disease • Prior Probability : the prevalence

Prior Probability:

the prevalence of the condition prior to the test.

in patients who do not have the disease • Prior Probability : the prevalence of the

Characteristics of Instrument Performance

Characteristics of Instrument Performance CH-1 • Two classes of characteristics are used to evaluated and compare

CH-1

Characteristics of Instrument Performance CH-1 • Two classes of characteristics are used to evaluated and compare

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

1.9 Generalized Static Characteristics CH-1 Parameters used to evaluate medical instrument: • Accuracy : The

CH-1

1.9 Generalized Static Characteristics CH-1 Parameters used to evaluate medical instrument: • Accuracy : The

Parameters used to evaluate medical instrument:

Accuracy:

The difference between the true value and the measured value divided by the true value

Precision:

measured value divided by the true value • Precision : The number of distinguishable alternatives from

The number of distinguishable alternatives from which a

given results is selected {2.434v or 2.43v}

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

1.9 Generalized Static Characteristics CH-1 Parameters used to evaluate medical instrument: • Statistical Control :

CH-1

1.9 Generalized Static Characteristics CH-1 Parameters used to evaluate medical instrument: • Statistical Control :

Parameters used to evaluate medical instrument:

Statistical Control:

Accuracy is meaningful if all environmental factors are known Ensures:

Systematic errors or bias are tolerable or can be removed by calibration.

Systematic error / bias can be removed by calibration / correction factors , but random variation more difficult

Statistical Sensitivity:

Static calibration = hold all inputs constant except one incrementally increase

that input

The ratio of the incremental output quantity to the incremental input quantity, Gd.

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

CH-1

the squared difference between data points and the line CH-1 36 n: Total number of points
the squared difference between data points and the line CH-1 36 n: Total number of points

36

n: Total number of points y  mx b d    n x
n: Total number
of points
y  mx b
d
n
x
y
 

-
x
y
d
d
m 
2
2
n
x
-
x
d
d

2
 
y
x
-

x
y
x
d
d
d
b 
2
2
n
x
-
x
d
d

1.9 Generalized Static Characteristics

1.9 Generalized Static Characteristics CH-1 Zero Drift : all output values increase or decrease by the

CH-1

1.9 Generalized Static Characteristics CH-1 Zero Drift : all output values increase or decrease by the

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.

37

zero drift and sensitivity drift. Dotted lines indicate that zero drift and sensitivity drift can be

Linearity

CH-1

(x 1 + x 2 ) x 1 y 1 Linear Linear system system
(x 1 + x 2 )
x 1
y 1
Linear
Linear
system
system

Independent nonlinearity

y 1 Linear Linear system system Independent nonlinearity ( y 1 + y 2 ) and
y 1 Linear Linear system system Independent nonlinearity ( y 1 + y 2 ) and

(y 1 + y 2 )

and

Linear

y

2

system

 
1 + y 2 ) and Linear y 2 system   and Linear system Ky 1

and

Linear

system

Linear system
Linear system

Ky 1

y 2 system   and Linear system Ky 1 - A% deviation of the reading -

- A% deviation of the reading

- B% deviation of the full scale

x 2

of the reading - B% deviation of the full scale x 2 Kx 1 y (Output)

Kx 1

of the reading - B% deviation of the full scale x 2 Kx 1 y (Output)
y (Output) Overall tolerance band
y (Output)
Overall tolerance band

A% of reading

x d (Input)

Least-squares

straight line

(a)

B% of full scale

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 (whichever permits the larger error).

Input Ranges ( I ):

Point at which A% of reading = B% of full scale

(b)

Minimum resolvable input < I < normal linear operating range
38

Example

Example CH-1 A linear system described by the following equation y=2x+3. Find the overall tolerance band

CH-1

Example CH-1 A linear system described by the following equation y=2x+3. Find the overall tolerance band

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.

y 23 3 10 x 0
y
23
3
10
x
0

0.5% FSD = .05 1.5% Rdng = .15

Input Impedance

•

Disturb the quantity being measured.

CH-1

Impedance • Disturb the quantity being measured. CH-1 • X d 1 : desired input (voltage,

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

Z x

X

d1

X d2

effort variable

flow variable

P

X

d1

X

d2

X

2

d1

Z

x

Z

x

X

2

d2

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
40

1.10 Generalized Dynamic Characteristics

1.10 Generalized Dynamic Characteristics Most medical instrument process signals that are functions of time. The input

Most medical instrument process signals that are functions of time. The input x(t) is related to the output y(t) by

a

n

d

n

y

dt

n



a

1

dy

dt

a

0

( )

y t

b

m

d

m

x

dt

m



b

1

dx

dt

b x t

0

( )

CH-1

m d m x dt m  b 1 dx dt  b x t 0

a i and b i depend on the physical and electrical parameters of the system.

a

n

D

n



a D

1

a

0

y t

( )

b

m

D

m



b D

1

b

0

x t

( )

Transfer Functions

The output can be predicted for any input (transient, periodic, or random)

y

(

D

)

x

(

D

)

b

m

D

m



b D

1

b

0

a

n

D

n



a D

1

a

0

Frequency Transfer Function Can be found by replacing D by j

Transfer Function Can be found by replacing D by j  y ( D ) b

y

(

D

)

b

m

D

m



b D

1

b

0

 

 
 

x

(

D

)

a

n

D

n



a D

1

a

0

j

)

Y

(

jω

)

b

m

(

jω

)

m 

b

1

(

jω

)

b

0

 

X

(

jω

)

 

a

n

(

jω

)

n 

a

1

(

jω

)

a

0

H (

Example:

CH-1

a 1 ( j ω )  a 0 H ( Example: CH-1 If x (

If

x(t) = A x sin (t)

then

y(t) = |H()| A x sin (t + /_H())

Zero-Order Instrument

CH-1

Zero -Order Instrument CH-1 a 0 y ( t ) = b 0 x ( t

a 0 y(t) = b 0 x(t)

y

(

D

)

Y

(

jω

)

 
 

x

(

D

)

X

(

j

)

b

0

a

0

K

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.

(c) Step response is proportional to input. (d) Sinusoidal frequency response is constant with zero phase
(c) Step response is proportional to input. (d) Sinusoidal frequency response is constant with zero phase

43

First-Order Instrument

First -Order Instrument a 1 dy t ( ) dt  a 0 ( ) y

a

1

dy t

( )

dt

a

0

( )

y t

b x t

0

( )

τD1y(t) Kx(t)

a

1

a

0

y

(

D

)

K

 

x

(

D

)

1 τD

K

Y jω   X  jω  Y jω   X  jω
Y jω
X
 jω
Y jω
X
K  1  jω τ K  2 2 1  ωτ
K
1
 jω
τ
K
2
2
1  ωτ

b

0

a

0

y



t

K

1

-

e -

t /

Where is the time constant

arctan

- ω

τ/1

CH-1

a 0   y  t  K  1 - e - t /

First-Order Instrument

Output y(t) dy t ( ) R RC  y t ( )  x
Output y(t)
dy t
( )
R
RC
y t
( )
x t
( )
dt
+
+
  RC
K 1 x(t) 1
Slope = K = 1
x(t)
C
y(t)
-
-
Input x(t)

y

(

D

)

K

 

x

(

D

)

1 τD

y



t

K

1

-

e -

t /

Example 1.1:

Low-pass filter

(a)

1

x( t ) (t)

t

- t /   Example 1.1: Low -pass filter (a) 1 x ( t )

(c)

y(t) 1 0.63  S  L t
y(t)
1
0.63
 S
 L
t
(b) Log Y (j scale X (j 1.0 0.707  S  L Log scale
(b)
Log
Y (j
scale
X (j
1.0
0.707
 S
 L
Log scale 
 L
 S

(d)

 0°  S Log scale   L - 45° -90°
 S
Log scale 
 L
- 45°
-90°

CH-1

1.0 0.707  S  L Log scale   L  S (d)  0°

Second-Order Instrument Many medical instrument are 2 nd order or higher

Many medical instrument are 2 n d order or higher a 2 d 2  y

a

2

d

2



y t

dt

2

a

1



dy t

dt

a yt

0

b xt

0

D

2

ω

2

n

2

ζD

ω

n

1

yt

Kxt

K

b

0

static sensitivity, output units defined by input units

ω n

a 0 a 0 a 2
a
0
a
0
a
2

undamped natural frequency, rad/s

Operational Transfer Function

Frequency Transfer Function

ζ  a 1  damping ratio, dimensionless 2 a a 0 2 y 
ζ 
a 1  damping ratio, dimensionless
2
a a
0
2
y
D
K
2
x D
D
2
ζD
 1
2
ω
ω
n
n

46

Y jω   K  X  jω   jω / ω 
Y jω
K
X
 jω
/ ω
2
2
ζjω ω
/
1
n
n
Y jω
K
X
2

2
2
2
2
1
-
ω ω
/
4
ζ ω ω
/
n
n

arctan

2 ζ

ω ω

/

n

-

/

ω ω

n

CH-1

   2 2 2 2 1 - ω ω /  4 ζ ω

2 nd order mechanical force-measuring Instrument

2 n d order mechanical force-measuring Instrument CH-1 B = viscosity constant K s = spring

CH-1

2 n d order mechanical force-measuring Instrument CH-1 B = viscosity constant K s = spring

B = viscosity constant K s = spring constant



x t

-

B



dy t

dt

K 1/ K s K ω n  s M B ζ  2 K
K 1/ K
s
K
ω n 
s
M
B
ζ 
2 K M
s

Natural freq.

Damping ratio

-

K

s



y t

M

d

2



y t

dt

2

Figure 1.7 (a) Force-measuring spring scale, an example of a second-order instrument. (b) Static sensitivity. (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.

Output Input displacement Force x(t) 0 y(t) (a) x(t) 1 t
Output
Input
displacement
Force x(t)
0
y(t)
(a)
x(t)
1
t

(c)

y(t) y n y n + 1 1 K s 0.5 1 2 t
y(t)
y n
y n + 1
1
K s
0.5
1
2
t
Output y(t) Slope K = 1 K s
Output y(t)
Slope K = 1
K s
y n + 1 1 K s 0.5 1 2 t Output y(t) Slope K =
y n + 1 1 K s 0.5 1 2 t Output y(t) Slope K =

Input x(t)

Y (j X (j 2 1
Y
(j
X
(j
2
1

(b)

Resonance

0.5

Log

scale

K

n

X (j 2 1 (b) Resonance  0.5 Log scale K n Log scale  (d)

Log scale

(d)

0

-90°

-180°

  n Log scale  ° 0.5 2 1
n
Log scale 
°
0.5
2
1

Overdamped

ζ 1:

2 2 2   2  ζ  ζ - 1  - 
2
2
2
2
ζ
ζ
-
1
 - 
ζ
ζ
-
1
ω t
ζ
-
ζ
-
1
 -
ζ
-
ζ
-
1
ω t
n
n
y t
 
-
Ke
Ke
K
2
2
2
ζ -
1
2
ζ -
1

48

Critically damped

ζ 1:

yt

1

- 

ω tKe

n

- ω t

n

Underdamped

ζ 1:

K

- ζω t n y(t) e  2  y t  - K sin
- ζω t
n
y(t)
e
2
y t

-
K
sin
1 -
ζ ω t
K
n
2
1 - ζ
1
K
s
2
arcsin
1
- ζ
0.5
  1-
2
d
n
Damped natural freq.
t

CH-1

 K n 2 1 - ζ 1 K s 2   arcsin 1 -

Example 1.2: for underdamped second-order instruments, find the damping ratio from the step response

CH-1

   y t - - ζω t e n 2 1 - ζ K
   y t - - ζω t e n 2 1 - ζ K
 



y t

-

- ζω t e n 2 1 - ζ
- ζω t
e
n
2
1 - ζ

K sin

 y t - - ζω t e n 2 1 - ζ K sin

K



3 π / 2 -  t  n 2 ω 1 - ζ n
3 π / 2 -
t
n
2
ω
1 -
ζ
n

and

K

 

 

-

7 π / 2 -  t  n  1 2 ω 1 -
7 π / 2 -
t
n  1
2
ω
1 -
ζ
n

3 π / 2 -

 
 

y

n

2 1 - ζ
2
1 - ζ

ζω   



exp

n

ω

n

1 - ζ
1
-
ζ

2

y n 1

K


 

-

ζω

7 π / 2 -

2 1 - ζ
2
1 - ζ

2 πζ

exp

ln

n

y

n

ω

n

2 1 - ζ
2
1
-
ζ



2 πζ

ζ

49

exp

2 1 - ζ
2
1 - ζ

y

n 1

Logarithmic decrement

2 1 - ζ
2
2

1 - ζ

2 1 - ζ     y n  1   Logarithmic decrement

2

4 π 

2

Time Delay System

y t   Kx t - τ  d  t τ d Log
y t

 Kx t - τ
d 
t τ
d
Log
scale
Y (j
K
Y jω
X (j
-
 Ke
d
X jω
Log scale 

Output is exactly as input, only delayed

0 °

 Log scale  τ d
Log scale 
τ
d

CH-1

Ke d X jω   Log scale  Output is exactly as input, only delayed

Design Criteria

Design Criteria Figure 1.8 Design process for medical instruments Choice and design of instruments are affected

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.

CH-1

design of instruments are affected by signal factors, and also by environmental, medical, and economic factors.

Commercial Medical Instrumentation Development Process

Commercial Medical Instrumentation Development Process CH-1 • Ideas: come from people working in the health care

CH-1

Commercial Medical Instrumentation Development Process CH-1 • Ideas: come from people working in the health care

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)

Whatis required but nothing about how

Design and development (software and hardware)

Commercial Medical Instrumentation Development Process

Commercial Medical Instrumentation Development Process CH-1 • Prototype development • Testing on animals or human

CH-1

Commercial Medical Instrumentation Development Process CH-1 • Prototype development • Testing on animals or human

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

Regulation of Medical Devices Medical devices is “ any item promoted for a medical purpose that

Medical devices is any item promoted for a medical

purpose that does not rely on chemical action to achieve its

intended effect

CH-1

on chemical action to achieve its intended effect ” CH-1 2 Ways for Medical Devices Classification

2 Ways for Medical Devices Classification

First Method: (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

Regulation of Medical Devices Second Way of classifications : ( Table 1.2 ) CH-1 Preamendment: Devices

Second Way of classifications: ( Table 1.2 )

CH-1

Devices Second Way of classifications : ( Table 1.2 ) CH-1 Preamendment: Devices on the market

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