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Lecture 1a Introduction CH 1

Here are potential answers to the practice questions: 1. Patents are filed with the US Patent and Trademark Office. Patents follow a specific format including claims, drawings, description, etc. 2. Animal and clinical studies must be approved by an Institutional Review Board and follow guidelines for ethical treatment and safety of subjects. 3. Examples of FDA categories: Class I - thermometer, Class II - pacemaker, Class III - artificial heart. 4. Negative feedback in glucose sensor reduces output as glucose levels rise. Positive feedback in ultrasound amplifies signal. 5. Overdamped gives smoother but slower response. Underdamped gives oscillatory response. Critically damped gives fastest response without oscill

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103 views17 pages

Lecture 1a Introduction CH 1

Here are potential answers to the practice questions: 1. Patents are filed with the US Patent and Trademark Office. Patents follow a specific format including claims, drawings, description, etc. 2. Animal and clinical studies must be approved by an Institutional Review Board and follow guidelines for ethical treatment and safety of subjects. 3. Examples of FDA categories: Class I - thermometer, Class II - pacemaker, Class III - artificial heart. 4. Negative feedback in glucose sensor reduces output as glucose levels rise. Positive feedback in ultrasound amplifies signal. 5. Overdamped gives smoother but slower response. Underdamped gives oscillatory response. Critically damped gives fastest response without oscill

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Lecture 2:

Basic Concepts

580.470/580.670 Molecular and


Cellular Instrumentation
Instrumentation design and development
is a creative process involving an idea and then taking it to
the implementation level (prototype => product). Key
deliverable is also a patent. Medical Instrumentation
development has more exacting demands since human
health depends on the performance of the device. The key
regulatory barriers are: animal/clinical protocol approval,
investigational device examination/clinical engineering
certification, FDA approval. The prototype to the medical
product is a long, expensive, and highly regulated process.
• The key concerns of the FDA are: safety and efficacy
• The key categories of FDA regulation are: Class I (General
controls=>labelling), Class II (Performance standards;
grand-fathering before 1976), Class III (Premarketing
approval).
• You should be familiar with the issue of
• Patents
• University/medical center regulations (animal,
clinical)
• FDA
• In the development of the device, you should be
familiar with
• Measurement factors (instrumentation)
• Environmental factors, social Medical factors;
aesthetics, history, tradition, liability…
• Economic factors: cost-benefit, profit,
Food and Drug Administration
(FDA)
Government body entrusted with the responsibility to regulated medical
devices, drugs, etc.
Primary task: certify safety and efficacy
FDA regulates through FDA Instrumentation
Categories
Design Control Class I
Process Control Class II
Good Manufacturing Practices Class III

What FDA Categories do the Instruments in


the Previous Slide Belong to?
FDA Device Regulations
• Class I – General Controls
– Required to perform registration, labeling, and good
manufacturing practices and to report adverse effects
• Class II – Performance Standards
– Required to prove “substantial equivalence” via the
510(k) process
• Class III – Pre-market Approval (PMA)
– Requires extensive testing and expert scrutiny
– PMA is necessary for devices used in supporting or
sustaining human life
General Medical Instrumentation
System
Measurand
Output
(e.g. blood pressure,
Display
ECG potential, etc.)

Sensing Signal
Element Processing
http://www.qubitsystems.com/electro.html

• Sensors such as electrodes, pressure transducer


• Instrumentation: amplifier, filter, signal conditioning
• Microprocessor, telemetry, Internet interface
• Case study (student project): Wireless heart rate alarm
via cell phone
Inter-
ference
“Induced” System Block Diagram

Transfer Function

Output
Input
Signal
source
Internal System Properties
interference
(added) • Accuracy, Precision
• Linearity, nonlinearity
• Response function (1st, 2nd order)
• Step response, transient response
• Stability, temperature response
• Noise, interference rejection
Sources of Signal Interference
• Any measurement
includes signal+noise
• Signal sources: ECG.
EEG, blood pressure,
temperature…
• Noise sources
– External: 60 Hz, radio
frequency (RF),
magnetic…
– Internal: muscle noise,
motion artifact, eye blink
artifact… Taken from http://www.temple.edu/biomed/
Principles of Measurements I
• Linearity, Accuracy, Stability… => apply to
real problems, applications
• First order, second order systems…=>
apply to real problems, applications
System Linearity
• Properties required for x1 y1
Linear
a linear system System
– If y1 and y2 are the
x2 y2
responses to x1 and x2, Linear
System
respectively, then y1 + y2
is the response to x1 + x2 y1 + y2
x1 + x2 Linear
and Ky1 is the response System
to Kx1, where K is a
constant. Kx1 Linear Ky1
System
• Linearity is necessary
for a system that has a
linear calibration curve.
Dynamic System
Characteristics
• General Form of Input-Output Relationship
dny dy d mx dx
– Time-Domain a n n + ... + a1 + a 0 y (t ) = bm m + ... + b1 + b0 x(t )
dt dt dt dt
Y ( jω ) bm ( jω ) m + ... + b1 ( jω ) + b0
– Transfer Function H ( jω ) = =
X ( jω ) an ( jω ) n + ... + a1 ( jω ) + a0

• Most instruments are of zero, first or second


order
– n = 0,1, or 2; m = 0.
• Input is typically transient (step function),
periodic (sinusoid), or random (bounded white
noise)
Zero-Order System
• Expression of the
input-output
relationship
– Time-domain
Relationship
a0 y (t ) = b0 x(t )
– Transfer Function
b0
H ( jω ) =
a0
• Example
– Linear potentiometer
First-Order System
• System contains a single energy-storage
element
• Time-domain relationship
dy
a1 + a0 y (t ) = b0 x(t )
dt
• Transfer Function
b0
H ( jω ) =
a1 ( jω ) + a0
• Example
– RC Low-pass or High-pass Filters
Simple First-Order Circuits
• Properties: Low-pass Filter
attenuation, delay, + +

transient response, x(t)


-
y(t)
-

loss of frequency (low


or high)
High-pass Filter
• Think of the examples
of first order systems? +
x(t)
+
y(t)

- -

http://hyperphysics.phy-astr.gsu.edu/hbase/electric/filcap2.html
Second-Order System
• Second-order system can approximate higher-
order systems
• Time-domain Relationship
d2y dy
a 2 2 + a1 + a0 y (t ) = b0 x(t )
dt dt
• Transfer Function
b0
H ( jω ) =
• Example a 2 ( jω ) 2 + a1 ( jω ) + a0
– Mechanical force-measuring instrument
– Pressure transducer
Second-Order System
• Over-damped
a1
ξ= >1
2 a0 a 2
• Critically-damped
a1
ξ= =1
2 a0 a 2

• Under-damped
a1
ξ= <1
2 a0 a 2
Practice Questions
• Who do you file patent with? What is the basic style of a
patent?
• What regulations are followed to do animal/clinical
studies?
• Give several examples of each of the FDA categories.
• Give examples of negative feedback and positive
feedback in medical sensors and instruments
• Pressure sensor may be modeled as a second order
system. How does over/under/critically damped
measurement affect Pressure reading?

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