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‫الثﻼثاء ‪ 23‬صفر ‪1446‬هـ ‪ 27‬أغسطس ‪2024‬م‬ ‫‪ 206‬مصانع قائمة للدواء والمعدات الطبية بالمملكة‬

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 Lecture’s Agenda
 Terminology of Medicine and Medical Devices
 Medical Instrumentation System
 Operational Modes and Measurements Constraints
 Classifications of Biomedical Instruments
 Interfering and Modifying Input
 Compensation Techniques
 Biostatistics
 Generalized Static Characteristics
 Dynamic Characteristics
 Amplifiers and Signal Processing
 Inverting Amplifiers
 Non-inverting Amplifiers
 Differential Amplifiers
 Comparators
 Integrators and Differentiators
 Active Filters
 Frequency Response
 Input and Output Resistance
 Design Criteria
 Development Process
 Regulation of Medical Devices
BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #3

1.1 Terminology of Medicine and Medical Devices

 The book Medical Terminology: An Illustrated Guide (Cohen and
DePetris, 2013) is recommended.
https://www.fda.gov/medical-devices
 www.fda.gov www.fda.gov/MedicalDevices/DeviceRegulationandGuidance
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm

 www.uspto.gov

 Library Online Catalogs

 Engineering Village

 PubMed

Areas of Bio. Inst.: Bioelectronics, biomechanics, bio-optics, biosystems,

medical imaging, etc.
BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #4

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 1.2 Medical Instrumentation System

Figure 1.1 Generalized instrumentation system: 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.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #5

1.2 Medical Instrumentation System

 Measurand: Physical quantity, property or condition that the
system measures.
 Internal – Blood pressure
 Body surface – ECG or EEG potentials
 Peripheral – Infrared radiation
 Offline – Extract tissue sample, blood analysis, or biopsy

feedback
Electronic
Actuator instrumentation
signal Signal Output
Sensor conditioning processing display

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #6

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 Measurand

Parameter Range Frequency Sensor

Flowmeter
Blood flow 1-300 ml/s dc – 20 Hz
(ultrasonic)
Arterial blood Cuff, strain-
25-400 mm Hg dc – 50 Hz
pressure gage
Skin
ECG 0.5 – 4 mV 0.01 – 250 Hz
electrodes
Scalp
EEG 5 – 300 microV dc – 150 Hz
electrodes
Needle
EMG 0.1 – 5 mV dc – 10,000 Hz
electrodes
Strain-gage,
Respiratory 2 – 50
0.1 – 10 Hz nasal
rate breaths/min
thermistor

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #7

Sensor
 A sensor converts physical measurand to an electrical output.
 Sensor requirements:
 Selective – should respond to a specific form of energy in the
measurand
 Minimally invasive (invasive = requiring entry into a part of the
body)
 Should not affect the response of the living tissue

Electronic feedback
Actuator instrumentation
signal Signal Output
Sensor conditioning processing display

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #8

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 Signal Conditioning
 Signal Conditioning: Amplification and filtering of the signal
acquired from the sensor to make it suitable for display.
 Analog, digital or mixed-signal signal conditioning
 Time/frequency/spatial domain processing (e.g., filtering)
 Calibration (adjustment of output to match parameter
measured)
 Compensation (remove of undesirable secondary sensitivities)

Electronic feedback
Actuator instrumentation
signal Signal Output
Sensor conditioning processing display

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #9

Display/Storage Devices

feedback
Electronic
Actuator instrumentation
signal Signal Output
Sensor conditioning processing display

 Display Devices  Storage Media

 Paper chart
 Flashing light or
sound  Magnetic tape
 Electronic Memory
 Analog meter
 Computer hard disk
 Digital Meter  Other computer memory
 Computer monitor media

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #10

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 1.3 Operational Modes
 Sampling vs. continuous modes
 Sampling: Can be sampled infrequently: e.g., body
temperature, ion concentration.
 Continuous: For critical measurements requiring constant
monitoring, e.g., respiratory.
 Analog and digital modes
 Analog: able to take on any value within the dynamic range.
 Digital: accuracy, repeatability, reliability, noise-immunity, not
requiring periodic calibration.
 Real-time and delayed-time modes
 Acquire or display the result in real time: when urgent
feedback and control tasks depend on the output.
 Acquire or display the result in delayed time: e.g. cell culture.
 Gas flow, ECG.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #11

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1.4 Medical Measurement Constraints

 Signal / frequency ranges
 Most medical measurands are typically much lower than
conventional sensing parameters (VmV, DC100 Hz, mm
Hg).

 Interference and cross-talk

 Noise from environment, instruments, etc.
 Other measurands affect measurement (and can’t be isolated).
 e.g., cannot measure EEG without interference from EMG.
 Require filtering and/or compensation.

 Inaccessibility of many crucial variables in living

systems
 e.g., cardiac output is quite inaccessible.
 Physical sizes of many sensors --- prohibits the formation of a
proper measurandsensor interface.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #12

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 1.4 Medical Measurements Constraints
 Safety
 Due to interaction of sensor with living tissue, safety
is a primary consideration in all phases of the
design & testing process.
 The damage caused could be irreversible.
 In some cases, safe levels of energy is difficult to
establish.
 Safety of medical personnel also must be
considered.

 Operator constraints
 Reliable, easy to operate, capable of withstanding physical
abuse and durable.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #13

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1.5 Classifications of Biomedical Instruments

 Quantity that is sensed, such as pressure, flow, or
temperature.

 Principle of transduction, such as resistive, inductive,

capacitive, ultrasonic, or electrochemical.

 Organ system, such as the cardiovascular, pulmonary,

nervous, and endocrine systems.

 Clinical medicine specialties, such as pediatrics,

obstetrics, cardiology, or radiology.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #14

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 1.6 Interfering and Modifying Input
 Desired inputs
 Measurands that the instrument is designed to isolate.

 Interfering inputs
 Quantities that affect the instrument as a consequence of the
principles used to acquire and process the desired inputs.
 Interfering inputs generally not correlated to measurand and
often easy to remove/cancel.

 Modifying inputs
 Undesired quantities that indirectly affect the output by altering
the performance of the instrument itself.
 Modifying inputs may be correlated to the measurand more
difficult to remove.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #15

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1.6 Interfering and Modifying Input

ECG example:
 Desired input: ECG voltage.
 Interfering input: 60 Hz noise voltage, displacement
currents.
 Modifying input: orientation of the patient cables.

Interfering Input Instrument

Measuran
d
Modifying
Input Figure 1.2

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #16

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 1.7 Compensation Techniques
 Signal Filtering
A filter separates signals according to their frequencies.
Most filters accomplish this by attenuating the part of the
signal that is in one or more frequency bands.

 Opposing Inputs
An example of using the opposing-input method is to
intentionally induce a voltage from the same 60 Hz
magnetic field present in Figure 1.2 to be amplified and
inverted until cancellation of the 60 Hz noise in the
output is achieved.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #17

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1.8 Biostatistics
 Application of statistics to medical data is used:
 to design experiments and clinical studies.
 to summarize, explore, analyze, and present data.
 to draw inferences from data by estimation or hypothesis
testing.
 to evaluate diagnostic procedures.
 to assist clinical decision-making.

 Medical research studies can be classified as:

 Observational studies: Characteristics of one or more groups
of patients
are observed and recorded.
 Experimental intervention studies: Effect of a medical
procedure or
treatment is investigated.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #18

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 1.8 Biostatistics
Mean

Geometric mean

Standard deviation (s): spread of data

Standard deviation of the mean

Coefficient of variation:
permits comparison of different scales

Correlation coefficient: Measure of

the Measure of the relationship
between two numerical variables
for paired observations.
BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #19

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1.9 Generalized Static Characteristics

 Static Characteristics describe the performance of instruments
for dc or very low frequency inputs.

 Dynamic Characteristics describe the performance of instruments

for time varying inputs

 Complete characteristics
 Approximated by the sum of static and dynamic
characteristics.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #20

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 Instrument Characteristics
 Accuracy
 Difference between the true value and the measured value
divided by the true value.
 Precision
 Number of distinguishable alternatives from which a given
result is selected.

 Resolution
 Smallest incremental quantity that can be measured with
certainty.
 Reproducibility
 Ability of an instrument to give the same output for equal
inputs applied over some period of time.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #21

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Instrument Characteristics
 Statistical Control

 Consideration of environmental and other random variations.

 Techniques such as data averaging.

 Static Sensitivity

 Ratio of the change in output to the corresponding change in

input under static or steady state conditions.

 K = ∆y/ ∆x

 ∆x: change in input , ∆y: change in output

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #22

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 Instrument Characteristics

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #23

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Linearity
• A system or element is linear:
• if y1 is the response to x1,
and y2 is the response to x2,
then yl + y2 is the response
to x1 + x2, and
• Ky1 is the response to Kx1
• No instrument has a perfect
linear response.

• Non-linearity defined as
maximum deviation of any
output reading from linear fit
line.
• Non-linearity is usually
expressed as a percentage of
full-scale reading.
BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #24

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 Example 1.2
 In a design, Figure E1.2 circuit consisting
of a linear potentiometer to measure the
arc configuration in hospital beds monitor
backrest elevation which helps ensure the
proper angle is maintained for patients
was implemented.
 A 5 V excitation source was used and the
length of the potentiometer was 5 cm.
 The measurement system used to test the
arc configuration has input impedance
(RL) = 1 kΩ.
 Assuming that the wiper is in the middle of
the potentiometer whose value is 1000 Ω.
 What is the sensitivity of the potentiometer
system?
 What is the error in the measurement of
voltage caused due to low value of input
impedance?

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #25

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Answer

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 1.10 Dynamic Characteristics
 Engineering instruments can be described by ordinary linear
differential equations with constant coefficients

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Transfer Function
 Relationship between the input signal and the output signal
mathematically.
 If the transfer function is known, the output can be predicted for
any input.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #28

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 Zero-Order Instrument
 Simplest nontrivial form of the differential equation results when
all the a’s and b’s are zero except a0 and b0.

• Ideal dynamic performance, because the output is

proportional to the input for all frequencies and there
is no amplitude or phase distortion.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #29

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First-Order Instrument
 Instrument contains a single energy-storage element, then a first-
order derivative of y(t) is required in the differential equation.

where K = b0/a0 = static sensitivity, and  = al/a0 = time constant.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #30

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 Problem
 A first-order low-pass instrument must measure hummingbird
wing displacements (assume sinusoidal) with frequency content
up to 100 Hz with an amplitude inaccuracy of less than 5%. What
is the maximal allowable time constant for the instrument?

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #31

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Example 1.3
 A first‐order low‐pass instrument has a time constant of 20 ms.
Find the maximal sinusoidal input frequency that will keep output
error due to frequency response less than 5%. Find the phase
angle at this frequency.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #32

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 Example 1.4
 From a 2 kV source in series with a 20 kΩ resistor, calculate the
time required to charge a 100 μF defibrillator capacitor to 1.9 kV.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #33

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Example 1.5
 Temperature‐guided radiofrequency catheter ablation
was attempted with the catheter tip set to 70 °C to heat
the affected tissue.
 A type J thermocouple (sensitivity of 50 μV/°C and time
constant of 2 s) was used to measure this temperature.
 The thermocouple could be modeled as a first‐order
system.
 Write the first‐order system model for this
thermocouple.
 Use MATLAB code to plot the response of the
thermocouple when it is suddenly exposed to the
catheter tip temperature of 70 °C.
 How much time does it take to reach a steady state
reading?

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #34

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 Answer
where K = b0/a0 = static sensitivity, and  = al/a0 = time constant.

%% Step response for the thermocouple system

K = 50 * power(10,–6); % static sensitivity K = 50 μV/°C
tau = 2; % time constant tau = 2 s
u = 70; % step change of 70 °C
s = tf('s');
% to specify a TF model using a rational function in % Laplace
variable, s
G = K/(tau*s+1); % transfer function
figure, step(u*G); grid on; The steady‐state value is reached
ylabel('Amplitude, V'); xlabel('Time, s'); in approximately 10 s.
BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #35

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Second-Order Instrument
 Instrument is second order if a second-order
differential equation is required to describe its dynamic
response.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #36

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 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. [Part

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #37

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Time Delay
 Instrument elements that give an output that is exactly
the same as the input, except that it is delayed in time
by d, are defined as time-delay elements.
y (t )  K x(t   d ), t d
• Time delays are present in transmission lines (electric,
mechanical, hydraulic blood vessels, and pneumatic
respiratory tubing), magnetic tape recorders, and some
digital signal-processing schemes.
• If the instrument is used strictly for measurement and is not
part of a feedback‐control system, then some time delay is
usually acceptable. The transfer function for undistorted
signal reproduction with time delay becomes
Y(jω)/X(jω) = K ∠ (− ωτd).

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #38

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 1.11 Op-amp Amplifiers
 An op-amp has two inputs are vl and v2.
 A differential voltage between them causes current flow through
the differential resistance Rd.
 The differential voltage is multiplied by A, the gain of the op-amp,
to generate the output-voltage source.
 Any current flowing to the output terminal vo must pass through
the output resistance Ro.

 A = ∞ (ideal gain is infinity): practical values 20k – 200k

 vo = 0, when v1 = v2 (no offset voltage)
 Rd = ∞ (input impedance is infinity): CMOS op-amps are close to ideal
 Ro = 0 (output impedance is zero): practical values 20-100
 Bandwidth = ∞ (no frequency-response limitations) and no phase shift
 Gain Bandwidth product: practical values ~MHz
BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #39

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Op-amp Circuit Symbol

• A voltage at v1, the inverting input, is greatly
amplified and inverted to yield vo.
• A voltage at v2, the non-inverting input, is greatly
amplified to yield an in-phase output at vo.

RULE 1: When the op-amp output is in its linear range, the

two input terminals are at the same voltage.
RULE 2: No current flows into either input terminal of the
op-amp.
BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #40

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 1.12 Inverting Amplifiers

vi controls i.

Adder

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #41

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Example 1.8
 The output of a biopotential preamplifier that measures the electro‐oculogram
(Section 4.7) is an undesired dc voltage of ±5 V due to electrode half‐cell
potentials (Section 5.1), with a desired signal of ±1 V superimposed. Design a
circuit that will balance the dc voltage to zero and provide a gain of −10 for the
desired signal without saturating the op amp.

Figure E1.8(a) shows the design. We assume

that vb, the balancing voltage available from the
5 kΩ potentiometer, is ±10 V. The undesired
voltage at vi = 5 V. For va = 0, the current
through Rf is zero. Therefore, the sum of the
currents through Ri and Rb is zero.
BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #42

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 1.13 Non-inverting Amplifier
(a) A follower, vo = vi. (b) A noninverting amplifier, vi appears across Ri,
producing a current through Ri that also flows through Rf. (c) A lever with
arm lengths proportional to resistance values makes possible an easy
visualization of input–output characteristics, (d) The input–output plot shows
a positive slope of (Rf + Ri)/Ri in the central portion, but the output saturates
at about ±13 V.

Unity-gain follower.
Excellent candidate
as a buffer.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #43

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1.14 Differential Amplifiers

v3

v4

𝑣 𝑅
𝐺 = =
𝑣 −𝑣 𝑅

• Controllable gain → Great!

• Input resistance → very low for
inverting amplifier → Bad!
Fig. 1.12
• When v3=v4, the output must be 0.
BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #44

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 1.14 Differential Amplifiers
 However, the output of a practical differential amplifier not only
depends on the difference voltage, but also depends on the
average of the two input.
 The average of the two input signals is called common mode
signal, v3
Vc=(v3+v4)/2
and hence v4
vo=GcVc

𝑣 𝑣 𝑅
𝐺 = 𝐺 = =
𝑣 𝑣 −𝑣 𝑅

Common mode rejection ratio

CMRR is a metric used to quantify the ability of the device to reject

common-mode signals, i.e. those that appear simultaneously and in-
phase on both inputs.
BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #45

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Three-op-amp Differential Amplifiers

• To examine the effects of common‐mode
voltage, assume that v1 = v2.
v3 • By Rule 1, v1 appears at both negative inputs
to the op amps.
• This places the same voltage at both ends
Gc= 1 v4 of R1.
• Hence, current through R1 is 0.
• By Rule 2, no current can flow from the
op‐amp inputs.
• Hence, the current through both R2's is 0,
so v1 appears at both op‐amp outputs and
the Gc is 1.

Two additional op amps can provide high input impedance and gain
compared to one op-amp differential amplifier.

Common mode rejection ratio

2𝑅 + 𝑅 𝑅
𝐺 =
𝑅 𝑅

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #46

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 1.15 Comparators

Figure 1.13 (a) Comparator. When R3 = 0, vo indicates whether (vi+ vref) is

greater or less than 0 V. When R3 is larger, the comparator has hysteresis, as
shown in (b), the input–output characteristic.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #47

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Example 1.12
 A physiological signal (represented by a sinusoidal signal of
10 Hz) is amplified such that it has a voltage swing from −1 V to
+10 V. However, along with signal, the noise overriding the signal
gets amplified too.
 Design a comparator with hysteresis of window of 4 V, such that
the comparator flips to VOH = +12 V when the input is 0 V
and VOL = −12 V when the input is 4 V.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #48

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 Example 1.12
 For Figure 1.13(a) shown:
• The voltage at the + terminal of the op‐amp V+ =
[R3/(R2 + R3)] × Vo
• The voltage at the − terminal of the op‐amp V− = (Vi + Vref)/2
• The differential voltage Vd = V+ − V− =
[R3/(R2 + R3)] × Vo − (Vi + Vref)/2

• The upper threshold is given as VTU = [R3/(R2 + R3)] × (12) =

(Vi + Vref)/2; when Vi = 4 V {The o/p is considered for the value
before we reach the Vi of 4 V, which is 12 V}.

• The lower threshold is given as VTL = [R3/(R2 + R3)] × (−12) =

(Vi + Vref)/2; when Vi = 0 V {The o/p is considered for the value
before we reach the Vi of 0 V, which is -12 V}.

• Solving the above two equations, we have Vref = −2 V. Select R3 =

1 kΩ and R2 = 11 kΩ

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #49

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1.18 Integrators

Because any real integrator eventually

drifts into saturation, a means must be
provided to restore vo to any desired initial
condition.

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #50

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 1.19 Differentiators feedback resistor to
prevent oscillation

 Current through a capacitor is given by

 If dvi/dt is positive, i flows through R in a direction such

that it yields a negative v0.

 The frequency response of a differentiator is given by

the ratio of feedback to input impedance.

 Circuit gain increases as f increases and it is equal to

unity when wτ = 1.
BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #51

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1.20 Active Filters

2πfcτ =1; where fc is the corner frequency

Figure 1.19 Active filters. (a) A low-

pass filter attenuates high frequencies,
(b) A high-pass filter attenuates low
frequencies and blocks dc. (c) A
bandpass filter attenuates both low
and high frequencies.
BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #52

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 Example 1.15
 Design a second‐order
low‐pass filter with a unity
gain, corner frequency of
500 Hz, and 0 dB ripple in
the pass band. Calculate
the corner frequency
change when you make
selection for capacitor
from E24 series (5%
tolerance) and resistor
from E96 series (1%
tolerance).

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #53

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Example 1.15
 Using the Analog Devices—Analog Filter
Wizard tool, we can design a single‐stage
second‐order Butterworth filter to have a
corner frequency of 500 Hz and 0 dB ripple in
the pass band. Figure E1.15 shows the
Sallen–Key topology for the second‐order filter.
 Selecting the capacitor from the E24 series
(5% tolerance) and resistor from the E96
series (1% tolerance) yields R1 = 75 kΩ, R2 =
1.33 MΩ, C1 = 330 pF, and C2 = 3.3 nF.
 The corner frequency is given as

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 1.21 Frequency Response: Closed-Loop Gain

• Amplifier circuit is never

built using the op-amp open
loop.
• Ex: if we build an amplifier
circuit with a gain of 10, the
frequency response is flat
up to 400 kHz and is
reduced above that
frequency.
• Because the amplifier-circuit
gain can never exceed the
op-amp gain.

For more information on Compensation:

https://en.wikipedia.org/wiki/Frequency_compensation

BIOE 311 - Ibraheem Al-Naib Ch.1: Slide #55

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Gain-Bandwidth Product
 Gain-bandwidth product of the op amp is equal to the
product of gain and bandwidth at a particular
frequency.

 Unity-gain-bandwidth product is 4 MHz, a typical value

for op amps.

 Along the entire curve with a slope of -1, the gain-

bandwidth product is still constant, at 4 MHz.

 Higher-frequency applications, op amps such as the

OP-37E are available with gain-bandwidth products of
60 MHz.

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 1.23 Bias Current

 The two op‐amp inputs drive transistors, base or gate current

must flow all the time to keep the transistors turned on.
 This is called bias current, which for the 411 is about 200 pA.
 The difference between the two input bias currents is much
smaller than either of the bias currents alone.
 A degree of cancellation of the effects of bias current can be
achieved by having each bias current flow through the same
equivalent resistance.
 This is accomplished for the inverting amplifier and the
noninverting amplifier by adding, in series with the positive input,
a compensation resistor the value of which is equal to the parallel
combination of Ri and Rf.
 There still is an error, but it is now determined by the difference in
bias current.
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1.24 Input Resistance

Op-amp differential-input resistance Rd. For the FET-input 411, it is

1 TΩ, whereas for BJT-input op amps, it is about 2 MΩ.

• Amplifier-circuit input resistance Rai is about (105) × (2 MΩ) = 200

GΩ.
• The amplifier input impedance is much higher than the op-amp
input impedance Rd.

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 Input Resistance

 This value cannot be achieved in practice, because

surface leakage paths in the op-amp socket lower it
considerably.
 In general, all noninverting amplifiers have a very high
input resistance, equal to Rd times the loop gain.
 This is not to say that very large source resistances
can be used, because the bias current usually causes
much larger problems than the amplifier-circuit input
impedance.
 For large source resistances, FET op amps such as
the 411 are helpful.

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Inverting Amplifier

 The input resistance of an inverting amplifier is easy to

determine.
 Because the negative input of the op amp is a virtual
ground,

 Thus, the amplifier-circuit input resistance Rai is equal

to Ri, the input resistor.
 Because Ri is usually a small value, the inverting
amplifier has small input resistance.
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 Output Resistance
 The op-amp output resistance is about 40 Ω for the
typical op amp, which may seem large for some
applications.
 However, its value is usually not important because of
the benefits of feedback.
• To calculate the amplifier-circuit
output resistance Rao, assume that
load resistor RL is attached to the
output, causing a change in output
current Δio.
• Because io flows through Ro, there
is an additional voltage drop ΔioRo.
• The amplifier output impedance is
much smaller than the op-amp
output impedance Ro. Rao=Ro/A
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Output Resistance
• Thus, the amplifier-circuit output resistance Rao is about
40/(105) = 0.0004 Ω, a value negligible in most circuits.

• In general, all noninverting and inverting amplifiers

have an output resistance that is equal to Ro divided by
the loop gain.

Driving very small load resistances

 If RL is smaller than 500 Ω, the op amp saturates
internally
 Maximal current output for a typical op amp is 20 mA.
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 1.25 Design Criteria

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FDA (Food and Drug Administration )

What is a Medical Device?
Section 201(h) of the Federal Food, Drug, and Cosmetic Act
defines a medical device as follows:
An instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article,
including any component, part, or accessory, which is recognized
in the official National Formulary, or the United States
Pharmacopeia, or any supplement to them intended for use in the
diagnosis of disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man
or other animals, and
 which does not achieve any of its principal intended purposes
through chemical action within or in the body of man or other
animals and which is not dependent upon being metabolized for
the achievement of any of its principal intended purposes.

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 Class I Medical Devices
 Class I devices are defined as non–
life sustaining.

 Basic standards, premarket

notification, registration, device
listing, good manufacturing
practices, and proper record
keeping are all required.

 Device Examples: adhesive

bandage – I.V. stand – sunglasses

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Class II Medical Devices

 Class II medical device are also
considered non-life sustaining
but have to comply with both
Class I basic standards and
medical performance
standards.

 Class II devices are usually

exempt from the need to prove
safety and efficacy. The FDA,
however, may require additional
clinical or laboratory studies.

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 Class III Medical Device
 Class III devices were defined in 1976
as either sustaining or supporting life so
that their failure is life threatening.

 Class III devices almost always require

a Pre-Market Approval (PMA).

 PMA require all of the basic

requirements for class I and II devices,
plus failure mode analysis, animal tests,
toxicology studies, and then, finally,
human clinical studies, directed to
establish safety and efficacy.
https://www.accessdata.fda.gov/scripts/cdr
h/cfdocs/cfPCD/PCDSimpleSearch.cfm
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