Biomedical

Instrumentation
Winter 1393
Bonab University
Course information Intro

Prerequisites:
• Electronic Measurements
Recommended Books and Notes:
• 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, 3rd 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%

2
The main Course book Intro

J.G. Webster, “Medical

Instrumentation Application and
Design”, John Wiley & Sons, 4th
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 Intro

4
 ‫سرفصل مصوب وزارت‬ ‫‪Intro‬‬

‫‪5‬‬
Examples: Cochlear Implant Intro

• 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
6
Examples: Advances in Vision (Retinal Stimulation) Intro

• 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

7
Examples: Mini Gastric Imaging Intro

• 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 24–48 hours

8
A success story: The AutoAnalyzer (Technicon, 35 years) CH-1

• 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
• Now mainly in industrial processes: Water, soil extracts

9
Generalized Medical instrumentation system CH-1

Control
And
feedback

Power
Sensor source
Perceptible
Primary Variable Signal output
Output
Measurand Sensing Conversion processing display
element element

Calibration Data Data

signal storage transmission

Radiation,
electric current,
or other applied Figure 1.1 The sensor converts energy or information from the measurand
energy 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.
10
Measurand (quantity the system measures): Physical quantity CH-1

• 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
Sensor and Transducer CH-1

• Transducer
• Converts one form of energy to another

• Sensor
• Converts a physical measurand to an electrical output
• Interface with living system
Pulse Oximetry
• Minimize the energy extracted
• Minimally invasive

displacement electric voltage

pressure diaphragm Strain gage

12
Signal Conditioning CH-1

• Amplification

• Filtering

• Impedance matching

• Analog/Digital for signal processing

• Signal form (time and frequency domains)

13
Output Display CH-1

• Numerical

• Graphical

Beeps
• Discrete or continuous

• Visual

• Hearing

14
Auxiliary Element CH-1

• Calibration Signal (as early in signal processing chain

as possible)

• Control and Feedback (auto or manual)

• Adjust sensor and signal conditioning

15
1.3 Alternative Operational Modes CH-1

• 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
(Breathing out = Low impedance)

16
1.3 Sampling and Continuous Modes CH-1

• 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)
• Analog and Digital Modes
• Real-Time and Delayed-Time Modes

17
1.4 Medical Measurement Constraints CH-1

• 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

18
Ballistocardiograph CH-1

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
19 when the blood slams into the top of the aorta.
1.5 Classification of Medical Instrument CH-1

• Quantity that is sensed

• pressure, flow, temp
• Principle of transduction
• resistive, capacitive, electrochemical, ultrasound
• Organ system
• Cardiovascular
• Pulmonary
• Nervous
• Medicine specialties
• pediatrics, cardiology, radiology

20
1.6 Interfering and Modifying Inputs CH-1

• 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.
Effect of a burst or ESD (Electrostatic discharge)
disturbance on an electronic board.
http://incompliancemag.com/article/emc-design-in-the-ic-
environment-with-respect-to-esd-and-burst/

21
1.6 Interfering and Modifying Inputs CH-1

Electrodes

vecg
Z1 60-Hz +Vcc
ac magnetic
Zbody
Z2 field

+
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.
22
1.7 Compensation Techniques CH-1

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.

The four
electromagnetic
interference (EMI)
coupling modes

23
1.7 Compensation Techniques CH-1

•Inherent Insensitive (twist electrode wires in ECG)

•Negative Feedback to minimize Gd which is effected by the
modifying inputs
• (xd – Hfy)Gd = y (1.1)
• xdGd = y(1 + HfGd) (1.2)

Gd
• y xd (1.3)
1  H f Gd
•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)
24
Compensation Techniques- Example CH-1

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%)

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

25
1.8 Biostatistics CH-1

• 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

26
Medical Research Studies CH-1

• - 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
27
Statistical Measurements CH-1

• Measures of the mean and central tendency

- Mean
X 
 Xi
n

- 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

28
Statistical Measurements CH-1

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

 X 
2
-X
s
i

n -1
• For symmetric distribution 75% of the data lies between (mean
- 2s) and (mean + 2s)
 s
• Coefficient of variation: standardize the variation to compare CV   100%
data measured in different scales. X
29
Statistical Measurements CH-1

• 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 i - X Yi - Y 
 X   Y - Y 
2 2
i -X i

30
Methods for inference CH-1

Methods for inference about a value in a

population of subjects from a set of
observations.

• Estimation and confidence 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.
31
Methods for measuring the accuracy of a diagnostic procedure CH-1

• 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.

32
Characteristics of Instrument Performance CH-1

• 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.

33
1.9 Generalized Static Characteristics CH-1

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 {2.434v 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.

34
1.9 Generalized Static Characteristics CH-1

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.

35
Finding static sensitivity Gd using line equation with the minimal sum of
CH-1
the squared difference between data points and the line

n: Total number
of points

y  mxd  b

n xd y -  xd  y 
m
n x -  xd 
2 2
d

 y  x  -  x y  x 
2

b
d d d

n x -  x 
2 2
d d
36
1.9 Generalized Static Characteristics CH-1

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
 Linearity CH-1

x1 y1 (x1 + x2) (y1 + y2)

Linear Linear
Independent nonlinearity system system

and and
- A% deviation of the reading x2
Linear y2 Kx1
Linear
Ky1

- B% deviation of the full scale system

(a)
system

Least-squares
straight line
y (Output)
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
Overall tolerance band A% of the reading, or B% of full
scale, whichever is greater
(whichever permits the larger
xd (Input) error).
Point at which
Input Ranges (I): (b)
A% of reading = B% of full scale

Minimum resolvable input < I < normal linear operating range

38
Example CH-1

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

0 10 x

39
Input Impedance CH-1

• 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
2
X d1 effort variable X d1
Zx   P  X d1  X d2   Z x X d2
2
X d2 flow variable Zx
•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
40
much smaller then the Zx
1.10 Generalized Dynamic Characteristics CH-1

Most medical instrument process signals that are functions

of time. The input x(t) is related to the output y(t) by
dny dy d mx dx
an n      a1  a0 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
n
     a1 D  a0 y(t )  bm D m      b1 D  b0 x(t )
Transfer Functions
The output can be predicted for any input (transient,
periodic, or random)
y( D) bm D      b1 D  b0
m

x( D) an D n      a1 D  a0
41
Frequency Transfer Function CH-1
Can be found by replacing D by j

y( D) bm D      b1 D  b0
m

x( D) an D n      a1 D  a0
Y ( jω) bm ( jω) m      b1 ( jω)  b0
H ( j )  
X ( jω) an ( jω) n      a1 ( jω)  a0

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

42
Zero-Order Instrument CH-1

a0 y(t) = b0 x(t)
y( D) Y ( jω) b0
  K
x( D) X ( j ) 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.

43
First-Order Instrument CH-1

dy(t )
a1  a0 y(t )  b0 x(t )
dt
τD  1y(t )  Kx(t ) 
yt   K 1 - e -t /  
 
a1
K 
b0 Where  is the time constant
a0 a0

y( D) K

x( D) 1  τD
Y  jω K

X  jω 1  jωτ
Y  jω
  arctan- ωτ/1
K

X  jω 1  ω2 τ 2
44
First-Order Instrument CH-1

Output y(t)

dy(t ) R

RC  y(t )  x(t ) + +
dt
C Slope = K = 1
x(t) y(t)

  RC K  1 x(t )  1 - -
Input x(t)
(a) (b)
y( D) K
 x(t) Log Y (j
x( D) 1  τD scale X (j


yt   K 1 - e -t / 
 1 1.0
0.707 S

L

t
L S Log scale 
(c) (d)

y(t) 

Example 1.1: 0.63

1 0°

- 45°
L
S Log scale 

Low-pass filter S L
-90°
t
45
Second-Order Instrument Many medical instrument are 2nd order or higher CH-1

d 2 yt  dyt   D 2 2ζD 

 1 yt   Kxt 
a2  a1  a0 yt   b0 xt   2 
dt 2
dt  ωn ωn 
b0
K  static sensitivity, output units defined by input units
a0
a a1
ωn  0  undamped natural frequency, rad/s ζ  damping ratio, dimensionl ess
a2 2 a0 a2

y D  K
Operational Transfer Function  2
xD  D 2ζD
 1
ωn
2
ωn
Frequency Transfer Function
Y  jω K

X  jω  jω / ωn 2  2ζjω / ωn   1
Y  jω K 2ζ
   arctan
46
X  jω 1 - ω / ω    4ζ ω
n
2 2 2 2
/ ωn2 ω / ωn - ωn / ω
2nd order mechanical force-measuring Instrument CH-1

dyt  d 2 yt  Output Input

B = viscosity constant xt  - B - K s yt   M displacement Force x(t)
dt 2
0
dt y(t)
Ks = spring constant Output y(t)

K  1/ K s 1
Slope K =
Ks
Ks
ωn  Natural freq. (a)
(b)
Input x(t)
M x(t)
Log
Y (j Resonance
scale X (j
B
ζ 1 K
Damping ratio 2
1
0.5
2 Ks M
n Log scale 
Figure 1.7 (a) Force-measuring spring scale, an
t
(c) (d)
example of a second-order instrument. (b) Static y(t)
yn 0°
 n
Log scale 

sensitivity. (c) Step response for overdamped case

yn + 1 0.5
2
1
 = 2, critically damped case  = 1, underdamped
1
Ks -90°

case  = 0.5. (d) Sinusoidal steady-state frequency 1

0.5

response,  = 2,  = 1,  = 0.5.
2 -180°
t

47
Overdamped ζ  1: CH-1

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

Critically damped ζ  1 :

yt   -1  ωn t Ke - ωn t

K

Underdamped ζ  1 :
yt   -
e - ζωnt
1- ζ 2

K sin 1 - ζ 2 ωnt    K  y(t)

1
Ks

  arcsin 1 - ζ 2
0.5

d  n 1 -  2 Damped natural freq. t

48
Example 1.2: for underdamped second-order instruments, CH-1
find the damping ratio from the step response

yt   -
e- ζωnt
1- ζ 2

K sin 1 - ζ 2 ωnt    K 
3π / 2 -  tn1 
7π / 2 - 
tn  and
ωn 1 - ζ 2 ωn 1 - ζ 2

 K    3π / 2 -    
  exp - ζωn 
 1- ζ 2  2 
yn     ωn 1 - ζ   

yn1  K     π -     
  exp - ζωn  7 / 2
 

 1 - ζ 2    ω - ζ 2
  
    n 1 
 2πζ   yn  2πζ 
 exp   ln     ζ 
 1- ζ 2   yn1  1- ζ 2 4π 2  2
 
Logarithmic decrement
49
Time Delay System CH-1

yt   Kxt - τd  t  τd
Log
scale Y (j
Y  jω - jω d
K
X (j
 Ke
X  jω
Log scale 

Output is exactly as input, Log scale 
0°
only delayed

τd

50
Design Criteria CH-1

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.

51
Commercial Medical Instrumentation Development Process CH-1

•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)

52
Commercial Medical Instrumentation Development Process CH-1

•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

53
Regulation of Medical Devices CH-1

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 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
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Regulation of Medical Devices CH-1

Second Way of classifications: ( Table 1.2 )

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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