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Biomedical Instrumentation I
Lecture-1: Introduction to BM Instrumentation System
Dr Muhammad Arif, PhD
m.arif@faculty.muet.edu.pk
https://sites.google.com/site/mdotarif/teaching/bmi
Course Instructor
• Dr. Muhammad Arif, (PhD, Leeds, UK)
• Position: Assistant Professor
• Department: Biomedical Engineering
• Office: 01, Biomedical Instrumentation Lab
• Email: m.arif@faculty.muet.edu.pk
• Tel: +92 (22) 2772250-73, Ext: 7016
• Web: https://sites.google.com/site/mdotarif/
• (or Just Google mdotarif to get the site link)
Course Info
• Discipline: Biomedical Engineering
• Batch: 11-BM
• Term: 1st Term, 3rd Year
• Credit Hours: 4 Hours per Week
• Starting Date: 07-01-2013
• Suspension Date: 28-04-2013
Course Web Site
• https://sites.google.com/site/mdotarif/teach
ing/bmi
• Teaching Plan
• Announcements (check regularly!)
• Lecture Notes
• Assignments
• Test Results
• Sessional Marks
• Past Quiz/Test papers etc.
Course Teaching Staff
• Theory Lectures: Dr. Muhammad Arif
• Labs Practical/Tutorials: Engr. Sanwal Memon
Course Outline
• Introduction to Biomedical Instrumentation (BMI) System
• Transducers/Sensors
• The Origin of Biopotentials
• Biopotential Electrodes
• The Heart & Electrocardiogram (ECG)
• Biopotential Amplifiers
• Defibrillators & Pacemakers
• Measurement of Blood Pressure & Heart Sound
• Measurement of Blood Flow & Cardiac Output
• Measurements of the Respiratory System
• Spirometers, Ventilators & Respirators
• Principles of Ultrasonic Measurements
• Electrical Safety of Medical Equipment
About Lecture Slides
• Lectures slides of the course are a summary of material only.
• They do not contain enough detail on their own.
• They may contain illustrations, block diagrams, problems, key points
and short definitions of the corresponding topics.
• So, all students are advised to see the recommended texts for more
details.
Recommended Texts
1. Medical Instrumentation: application and
design, by John G. Webster (Editor),
John Wiley & Sons, 4th Edition.
Recommended Texts
2. Introduction to Biomedical Equipment
Technology, by Joseph J Carr, Prentice
Hall, 4th Edition.
Reference Texts
1. Biomedical Instrumentation and
Measurements by Leslie Cromwell, 2nd
Edition.
Reference Texts
2. Introduction to Biomedical Engineering,
by John D. Enderle, 3rd Edition.
Assessment
Why Study Biomedical Instrumentation
• Medical devices are used for
i. Diagnosing of disease
ii. Treatment of disease
iii. Care and monitoring of patients
• Important to know about medical devices
i. Technical, design, development aspects
ii. Physiological basis
iii. Clinical applications
iv. Safety and regulatory environment
Lecture Outline
• Generalized Medical Instrumentation System
• Components of Medical Systems
• Instrument Operational Modes
• Medical Measurand Constraints
• Classification of Medical Instruments
• Measurement Input Sources
• Characteristics of Instrument Performance
• System Static & Dynamic Characteristics
• General Design Criteria & Process of Medical Instruments
• Commercial Medical Instrumentation Development Process
Generalized Medical Instrumentation System
* Elements and connections shown by dashed lines are optional for some applications.
Components of Medical System
Measurand:
• The physical quantity, property, or condition that the system measures.
• The accessibility of the measurand is important because it may be:
i. Internal (eg. Blood Pressure)
ii. On the body surface (e.g. Electrocardiogram Potential)
iii. Emanate from the body (e.g. Infrared Radiation)
iv. Derived from a tissue sample (e.g. Blood or Biopsy)
•Medically Important measurands can be grouped in the following categories:
i.Biopotential
ii.Pressure
iii.Flow
iv.Dimensions (imaging)
v.Displacement (velocity, acceleration, and force)
vi.Impedance
vii.Temperature
viii.Chemical concentrations.
Components of Medical System
Transducer/Sensors:
• A transducer is a device that converts one form of energy to another.
• A sensor is a device that converts a physical measurand to an electric output.
• The sensor should be noninvasive or minimally invasive.
• The sensor should respond only to the form of energy present in the
measurand, to the exclusion of all others.
Components of Medical System
Signal Conditioning:
• Signal conditioner may amplifies, filter or merely match the impedance of
the sensor to the display.
• Often, sensor outputs are converted to digital form and processed by
specialized digital circuits or a microcomputer.
Components of Medical System
Output Display:
•The results of the measurement process must be displayed in a form that the
human operator can perceive.
•The best form for the display may be;
i.Numerical or Graphical
ii.Discrete or Continuous
iii.Permanent or Temporary
iv.Visual or Hearing
Components of Medical System
Auxiliary Component:
i. A calibration signal with properties of the measurand should be applied to
the sensor input or as early in the signal-processing chain as possible.
ii. Many forms of control and feedback may be required to elicit the
measurand, to adjust the sensor and signal conditioner, and to direct the
flow of output for display, storage or transmission. The control and
feedback may be automatic or manual.
Components of Medical System
Auxiliary Component: (continue)
iii. Data may be stored briefly to meet requirements of signal conditioning or
to enable operator to examine the data that precede alarm conditions. Or
data may be stored before signal conditioning, so that different
processing schemes can be utilized.
iv. Conventional principles of communication can often be used to transmit
data to remote displays at nurses’ stations, medical centers, or medical
data-processing facilities.
Instrument Operational Modes
Direct Mode
• Direct measurement of accessible measurands.
• If the sensor is invasive, direct contact with the measurand is possible but
expensive, risky and least acceptable.
i. Temperature
ii. Heart Beat
Indirect Mode
• Indirect measurement of inaccessible measurands
i. Morphology of internal organ: X-ray shadows
ii. Volume of blood pumped per minute by the heart: respiration and
blood gas concentration
iii. Pulmonary volumes: variation in thoracic impedance plethysmography
Instrument Operational Modes
Sampling Mode
•Infrequent monitoring of slow changing measurands
i.Body temperature
ii.Ion concentrations
Continuous Mode
•Frequent or constant monitoring of vital/critical measurands
i.Electrocardiogram
ii.Respiratory gas flow
Instrument Operational Modes
Generating Mode
• Generating sensors produce their outputs from energy taken from
measurand.
• Also known as self-powered modes.
Example: Photovoltaic cell is a generating sensor because it provides an
output voltage related to its irradiation, without any additional external
energy source.
Modulating Mode
• Modulating Sensors uses the measurand to alter the flow of energy from an
external source .
Example: Photoconductive cell is a modulating sensor; to measure its
change in resistance with irradiation, we must apply external energy to the
sensor.
Instrument Operational Modes
Analogue Mode
• Analogue or Continuous signal is able to take any value within a dynamic range.
• Most currently available sensors operate in the analog mode.
Digital Mode
• Digital or Discrete signal is able to take on only a finite number of values.
• The advantages of the digital mode of operation include greater accuracy,
repeatability, reliability, and immunity to noise.
Instrument Operational Modes
Real-Time Mode
• The results are displayed almost immediately.
Delayed-Time Mode
• The results are delayed due to considerable signal processing.
Medical Measurement Constraints
• The signal to be measured imposes constraints on how it should be
acquired and processed
• Many measurand in living systems are inaccessible
• Placement of sensor(s) in/on the body plays a key role in medical
instrumentation design
• Magnitude and frequency range of medical measurand are very low
• Interference and cross-talk artifacts
• Proper sensor interface with measurand cannot be obtained
• Medical variables are seldom deterministic (varying with time)
• Many medical measurements vary widely among normal patients, even
when conditions are similar.
• Safety of patient and medical personnel also must be considered
• Safe levels of stimulation or applied energy are difficult to establish,
• External energy must be minimized to avoid any damage
• Equipment must be reliable, easy to operate, and durable
• Government regulations
Common Medical Measurands
Classifications of Biomedical Instruments
Quantity that is sensed
• Makes comparison of different
technologies easy
i. Pressure
ii. Flow
iii. Temperature
Principle of transduction
• Makes development of new
applications easy
i. Resistive
ii. Capacitive
iii. Electrochemical
iv. Ultrasound
Organ systems
• Isolates all important measurements
for specialists who need to know
about a specific area
i. Cardiovascular system
ii. Pulmonary system
iii. Nervous system
Clinical specialties
• Easy for medical personnel
interested in specialized equipment.
i. Pediatrics
ii. Cardiology
iii. Radiology
Measurement Input Sources
1. Desired Inputs: measurands that the instrument is designed to isolate.
2. Interfering Inputs: quantities that inadvertently affect the instrument as a
consequence of the principles used to acquire and process the desired
inputs.
3. Modifying Inputs: undesired quantities that indirectly affect the output by
altering the performance of the instrument itself.
Example: ECG Signal Measurement
1.Desired Input: ECG voltage
2.Interfering Input: 60/50 Hz noise voltage, displacement currents
3.Modifying Input: – orientation of the patient cables when the plane of the
cable is perpendicular to the magnetic field the magnetic interference is
maximal
Measurement Input Sources
Figure: Simplified electrocardiographic recording system Two possible
interfering inputs are stray magnetic fields and capacitive 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.
Characteristics of Instrument Performance
• Performance of a new instrument is evaluated using the two classes of
characteristics which are based on the frequency of the input signals.
• This provides a quantitative criteria for the instruments performance.
• These criteria must specify how well an instrument measures the desired
input and how much output depends on interfering and modifying inputs.
1. Static Characteristics: describe the performance for dc or very low
frequency input.
2. Dynamic Characteristics: describe the performance for ac and high
frequency input
Generalized Static Characteristics
Following are the parameters used to evaluate medical instrument:
• Accuracy: refers to the degree of conformity between the measurand and
the standard. It can be calculated using the difference between the true
value and the measured value divided by the true value.
• Precision: refers to the degree of refinement of measurement. The number
of distinguishable alternatives from which a given results is selected {2.434
or 2.43}
Good Accuracy,
Good Precision
Good Accuracy,
Poor Precision
Poor Accuracy,
Good Precision
Poor Accuracy,
Poor Precision
Generalized Static Characteristics
• 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.
• Statistical control: ensures that random variations in measured quantities that
result from all factors that influence the measurement process is tolerable.
• Static sensitivity: is the ratio of the incremental output quantity to the
incremental input quantity.
Generalized Static Characteristics
• Zero drift: occurs when all the output values increase or decrease by the
same absolute amount due to manufacturing misalignment, variation in
ambient temperature, vibration etc.
• Sensitivity drift: causes output change in proportion to the magnitude of
the input. Change in the slope of the calibration curve.
Figure: Static sensitivity: zero drift
and sensitivity drift. Dotted lines
indicate that zero drift and
sensitivity drift can be negative.
Generalized Static Characteristics
• Linearity:
◦ If y1 = x1 and y2 = x2, then y1+y2 = x1+x2 and Ky1 = Kx1
• Input ranges: Normal linear operating range specifies the maximal inputs
that give linear output.
• Input impedance: Ratio of the phasor equivalent of a steady-state effort
input to flow input variable.
Generalized Dynamic Characteristics
• Most of the biological signals time-varying in nature and therefore we
should make sure that the instrument is a time-invariant system for an
accurate measurement.
• The dynamic characteristics of an instrument include its transfer function, its
frequency response, and its phase or time delay.
• Dynamic characteristics require the use of differential or integral equations
to describe the quality of the measurements.
• Transfer functions are used to predict the stability of a system.
• Zero-order instruments
◦ A derivative where the output is proportional to the input for all
frequencies.
◦ E.g. Linear potentiometer.
Generalized Dynamic Characteristics
• First-order instruments
◦ Devices that have a single energy storage element.
◦ E.g. Low-pass RC filter.
• Second-order instruments
◦ Instruments that need a second-order differential equation to describe its
dynamic response.
◦ E.g. Force-measuring spring scale.
• Time delay
◦ Instruments that produce exactly the same output as input, however with
delayed time.
◦ E.g. Equipment that require significant signal processing schemes.
Figure: Design process for medical
instruments Choice and design of
instruments are affected by signal
factors, and also by environmental,
medical, and economic factors.
General Design Criteria and
Process of Medical Instrument
Commercial Medical Instrumentation
Development Process
• Ideas: come from people working in the health care
• Detailed evaluation and signed disclosure
• Feasibility analysis and product description
 Medical need
 Technical feasibility
• Brief business plan (financial, sales, patents, standards, competition)
• Product Specification (interface, size, weight, color)
“What” is required but nothing about “how”
• Design and development (software and hardware)
• 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
Questions?

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357251698-Lecure-1-Introduction-to-Biomedical-Instrumentation-System-4-ppt.ppt

  • 1. Biomedical Instrumentation I Lecture-1: Introduction to BM Instrumentation System Dr Muhammad Arif, PhD m.arif@faculty.muet.edu.pk https://sites.google.com/site/mdotarif/teaching/bmi
  • 2. Course Instructor • Dr. Muhammad Arif, (PhD, Leeds, UK) • Position: Assistant Professor • Department: Biomedical Engineering • Office: 01, Biomedical Instrumentation Lab • Email: m.arif@faculty.muet.edu.pk • Tel: +92 (22) 2772250-73, Ext: 7016 • Web: https://sites.google.com/site/mdotarif/ • (or Just Google mdotarif to get the site link)
  • 3. Course Info • Discipline: Biomedical Engineering • Batch: 11-BM • Term: 1st Term, 3rd Year • Credit Hours: 4 Hours per Week • Starting Date: 07-01-2013 • Suspension Date: 28-04-2013
  • 4. Course Web Site • https://sites.google.com/site/mdotarif/teach ing/bmi • Teaching Plan • Announcements (check regularly!) • Lecture Notes • Assignments • Test Results • Sessional Marks • Past Quiz/Test papers etc.
  • 5. Course Teaching Staff • Theory Lectures: Dr. Muhammad Arif • Labs Practical/Tutorials: Engr. Sanwal Memon
  • 6. Course Outline • Introduction to Biomedical Instrumentation (BMI) System • Transducers/Sensors • The Origin of Biopotentials • Biopotential Electrodes • The Heart & Electrocardiogram (ECG) • Biopotential Amplifiers • Defibrillators & Pacemakers • Measurement of Blood Pressure & Heart Sound • Measurement of Blood Flow & Cardiac Output • Measurements of the Respiratory System • Spirometers, Ventilators & Respirators • Principles of Ultrasonic Measurements • Electrical Safety of Medical Equipment
  • 7. About Lecture Slides • Lectures slides of the course are a summary of material only. • They do not contain enough detail on their own. • They may contain illustrations, block diagrams, problems, key points and short definitions of the corresponding topics. • So, all students are advised to see the recommended texts for more details.
  • 8. Recommended Texts 1. Medical Instrumentation: application and design, by John G. Webster (Editor), John Wiley & Sons, 4th Edition.
  • 9. Recommended Texts 2. Introduction to Biomedical Equipment Technology, by Joseph J Carr, Prentice Hall, 4th Edition.
  • 10. Reference Texts 1. Biomedical Instrumentation and Measurements by Leslie Cromwell, 2nd Edition.
  • 11. Reference Texts 2. Introduction to Biomedical Engineering, by John D. Enderle, 3rd Edition.
  • 13. Why Study Biomedical Instrumentation • Medical devices are used for i. Diagnosing of disease ii. Treatment of disease iii. Care and monitoring of patients • Important to know about medical devices i. Technical, design, development aspects ii. Physiological basis iii. Clinical applications iv. Safety and regulatory environment
  • 14. Lecture Outline • Generalized Medical Instrumentation System • Components of Medical Systems • Instrument Operational Modes • Medical Measurand Constraints • Classification of Medical Instruments • Measurement Input Sources • Characteristics of Instrument Performance • System Static & Dynamic Characteristics • General Design Criteria & Process of Medical Instruments • Commercial Medical Instrumentation Development Process
  • 15. Generalized Medical Instrumentation System * Elements and connections shown by dashed lines are optional for some applications.
  • 16. Components of Medical System Measurand: • The physical quantity, property, or condition that the system measures. • The accessibility of the measurand is important because it may be: i. Internal (eg. Blood Pressure) ii. On the body surface (e.g. Electrocardiogram Potential) iii. Emanate from the body (e.g. Infrared Radiation) iv. Derived from a tissue sample (e.g. Blood or Biopsy) •Medically Important measurands can be grouped in the following categories: i.Biopotential ii.Pressure iii.Flow iv.Dimensions (imaging) v.Displacement (velocity, acceleration, and force) vi.Impedance vii.Temperature viii.Chemical concentrations.
  • 17. Components of Medical System Transducer/Sensors: • A transducer is a device that converts one form of energy to another. • A sensor is a device that converts a physical measurand to an electric output. • The sensor should be noninvasive or minimally invasive. • The sensor should respond only to the form of energy present in the measurand, to the exclusion of all others.
  • 18. Components of Medical System Signal Conditioning: • Signal conditioner may amplifies, filter or merely match the impedance of the sensor to the display. • Often, sensor outputs are converted to digital form and processed by specialized digital circuits or a microcomputer.
  • 19. Components of Medical System Output Display: •The results of the measurement process must be displayed in a form that the human operator can perceive. •The best form for the display may be; i.Numerical or Graphical ii.Discrete or Continuous iii.Permanent or Temporary iv.Visual or Hearing
  • 20. Components of Medical System Auxiliary Component: i. A calibration signal with properties of the measurand should be applied to the sensor input or as early in the signal-processing chain as possible. ii. Many forms of control and feedback may be required to elicit the measurand, to adjust the sensor and signal conditioner, and to direct the flow of output for display, storage or transmission. The control and feedback may be automatic or manual.
  • 21. Components of Medical System Auxiliary Component: (continue) iii. Data may be stored briefly to meet requirements of signal conditioning or to enable operator to examine the data that precede alarm conditions. Or data may be stored before signal conditioning, so that different processing schemes can be utilized. iv. Conventional principles of communication can often be used to transmit data to remote displays at nurses’ stations, medical centers, or medical data-processing facilities.
  • 22. Instrument Operational Modes Direct Mode • Direct measurement of accessible measurands. • If the sensor is invasive, direct contact with the measurand is possible but expensive, risky and least acceptable. i. Temperature ii. Heart Beat Indirect Mode • Indirect measurement of inaccessible measurands i. Morphology of internal organ: X-ray shadows ii. Volume of blood pumped per minute by the heart: respiration and blood gas concentration iii. Pulmonary volumes: variation in thoracic impedance plethysmography
  • 23. Instrument Operational Modes Sampling Mode •Infrequent monitoring of slow changing measurands i.Body temperature ii.Ion concentrations Continuous Mode •Frequent or constant monitoring of vital/critical measurands i.Electrocardiogram ii.Respiratory gas flow
  • 24. Instrument Operational Modes Generating Mode • Generating sensors produce their outputs from energy taken from measurand. • Also known as self-powered modes. Example: Photovoltaic cell is a generating sensor because it provides an output voltage related to its irradiation, without any additional external energy source. Modulating Mode • Modulating Sensors uses the measurand to alter the flow of energy from an external source . Example: Photoconductive cell is a modulating sensor; to measure its change in resistance with irradiation, we must apply external energy to the sensor.
  • 25. Instrument Operational Modes Analogue Mode • Analogue or Continuous signal is able to take any value within a dynamic range. • Most currently available sensors operate in the analog mode. Digital Mode • Digital or Discrete signal is able to take on only a finite number of values. • The advantages of the digital mode of operation include greater accuracy, repeatability, reliability, and immunity to noise.
  • 26. Instrument Operational Modes Real-Time Mode • The results are displayed almost immediately. Delayed-Time Mode • The results are delayed due to considerable signal processing.
  • 27. Medical Measurement Constraints • The signal to be measured imposes constraints on how it should be acquired and processed • Many measurand in living systems are inaccessible • Placement of sensor(s) in/on the body plays a key role in medical instrumentation design • Magnitude and frequency range of medical measurand are very low • Interference and cross-talk artifacts • Proper sensor interface with measurand cannot be obtained • Medical variables are seldom deterministic (varying with time) • Many medical measurements vary widely among normal patients, even when conditions are similar. • Safety of patient and medical personnel also must be considered • Safe levels of stimulation or applied energy are difficult to establish, • External energy must be minimized to avoid any damage • Equipment must be reliable, easy to operate, and durable • Government regulations
  • 29. Classifications of Biomedical Instruments Quantity that is sensed • Makes comparison of different technologies easy i. Pressure ii. Flow iii. Temperature Principle of transduction • Makes development of new applications easy i. Resistive ii. Capacitive iii. Electrochemical iv. Ultrasound Organ systems • Isolates all important measurements for specialists who need to know about a specific area i. Cardiovascular system ii. Pulmonary system iii. Nervous system Clinical specialties • Easy for medical personnel interested in specialized equipment. i. Pediatrics ii. Cardiology iii. Radiology
  • 30. Measurement Input Sources 1. Desired Inputs: measurands that the instrument is designed to isolate. 2. Interfering Inputs: quantities that inadvertently affect the instrument as a consequence of the principles used to acquire and process the desired inputs. 3. Modifying Inputs: undesired quantities that indirectly affect the output by altering the performance of the instrument itself.
  • 31. Example: ECG Signal Measurement 1.Desired Input: ECG voltage 2.Interfering Input: 60/50 Hz noise voltage, displacement currents 3.Modifying Input: – orientation of the patient cables when the plane of the cable is perpendicular to the magnetic field the magnetic interference is maximal Measurement Input Sources Figure: Simplified electrocardiographic recording system Two possible interfering inputs are stray magnetic fields and capacitive 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.
  • 32. Characteristics of Instrument Performance • Performance of a new instrument is evaluated using the two classes of characteristics which are based on the frequency of the input signals. • This provides a quantitative criteria for the instruments performance. • These criteria must specify how well an instrument measures the desired input and how much output depends on interfering and modifying inputs. 1. Static Characteristics: describe the performance for dc or very low frequency input. 2. Dynamic Characteristics: describe the performance for ac and high frequency input
  • 33. Generalized Static Characteristics Following are the parameters used to evaluate medical instrument: • Accuracy: refers to the degree of conformity between the measurand and the standard. It can be calculated using the difference between the true value and the measured value divided by the true value. • Precision: refers to the degree of refinement of measurement. The number of distinguishable alternatives from which a given results is selected {2.434 or 2.43} Good Accuracy, Good Precision Good Accuracy, Poor Precision Poor Accuracy, Good Precision Poor Accuracy, Poor Precision
  • 34. Generalized Static Characteristics • 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. • Statistical control: ensures that random variations in measured quantities that result from all factors that influence the measurement process is tolerable. • Static sensitivity: is the ratio of the incremental output quantity to the incremental input quantity.
  • 35. Generalized Static Characteristics • Zero drift: occurs when all the output values increase or decrease by the same absolute amount due to manufacturing misalignment, variation in ambient temperature, vibration etc. • Sensitivity drift: causes output change in proportion to the magnitude of the input. Change in the slope of the calibration curve. Figure: Static sensitivity: zero drift and sensitivity drift. Dotted lines indicate that zero drift and sensitivity drift can be negative.
  • 36. Generalized Static Characteristics • Linearity: ◦ If y1 = x1 and y2 = x2, then y1+y2 = x1+x2 and Ky1 = Kx1 • Input ranges: Normal linear operating range specifies the maximal inputs that give linear output. • Input impedance: Ratio of the phasor equivalent of a steady-state effort input to flow input variable.
  • 37. Generalized Dynamic Characteristics • Most of the biological signals time-varying in nature and therefore we should make sure that the instrument is a time-invariant system for an accurate measurement. • The dynamic characteristics of an instrument include its transfer function, its frequency response, and its phase or time delay. • Dynamic characteristics require the use of differential or integral equations to describe the quality of the measurements. • Transfer functions are used to predict the stability of a system. • Zero-order instruments ◦ A derivative where the output is proportional to the input for all frequencies. ◦ E.g. Linear potentiometer.
  • 38. Generalized Dynamic Characteristics • First-order instruments ◦ Devices that have a single energy storage element. ◦ E.g. Low-pass RC filter. • Second-order instruments ◦ Instruments that need a second-order differential equation to describe its dynamic response. ◦ E.g. Force-measuring spring scale. • Time delay ◦ Instruments that produce exactly the same output as input, however with delayed time. ◦ E.g. Equipment that require significant signal processing schemes.
  • 39. Figure: Design process for medical instruments Choice and design of instruments are affected by signal factors, and also by environmental, medical, and economic factors. General Design Criteria and Process of Medical Instrument
  • 40. Commercial Medical Instrumentation Development Process • Ideas: come from people working in the health care • Detailed evaluation and signed disclosure • Feasibility analysis and product description  Medical need  Technical feasibility • Brief business plan (financial, sales, patents, standards, competition) • Product Specification (interface, size, weight, color) “What” is required but nothing about “how” • Design and development (software and hardware) • 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