Medical Instrumentation
Design of instrument must match
Measurement needs (environmental conditions, safety, reliability, etc) Instrument performance (speed, power, resolution, range, etc)
A medical device is
any item promoted for a medical purpose that does not rely on chemical action to achieve its intended effect
[Medical Device Amendments (Public law 94-295)]
i.e., any electrical or mechanical device for medical applications
this class will focus on electrical (including electromechanical and electrochemical)
Difference from any conventional instrument
source of signals is living tissue energy is applied to the living tissue
Impact on biomedical instrumentation (BI) design requirements?
Reliability and Safety
ECE 445: Biomedical Instrumentation
Ch1 Basics. p. 1
Generalized Medical Instrumentation System
actuator sensor measurand electronic instrumentation feedback
signal conditioning
basic advanced
signal processing
output display storage transmission
Measurand: Physical quantity, property or condition that the system measures Types of biomedical measurands
Internal Blood pressure Body surface ECG or EEG potentials Peripheral Infrared radiation Offline Extract tissue sample, blood analysis, or biopsy
Typical biomedical measurand quantities
Biopotential, pressure, flow, dimensions (imaging), displacement (velocity, acceleration and force), impedance, temperature and chemical concentration
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 2
Medical and Physiological Parameters
Parameter Blood flow Arterial blood pressure ECG EEG EMG Respiratory rate Range 1-300 ml/s 25-400mm Hg 0.5 4 mV 5 300 microV 0.1 5 mV 2 50 breaths/min Frequency dc 20 Hz dc 50 Hz 0.01 250 Hz dc 150 Hz dc 10,000 Hz 0.1 10 Hz Sensor Flowmeter (ultrasonic) Cuff, strain-gage Skin electrodes Scalp electrodes Needle electrodes Strain-gage, nasal thermistor
Ch1 Basics. p. 3
ECE 445: Biomedical Instrumentation
Sensor
actuator sensor measurand electronic instrumentation feedback
signal conditioning
basic advanced
signal processing
output display storage transmission
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)
sensor should not affect the response of the living tissue
Most common types of sensors in biomedical systems
displacement pressure
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 4
Signal Conditioning
actuator sensor measurand electronic instrumentation feedback
signal conditioning
basic advanced
signal processing
output display storage transmission
Signal Conditioning: Amplification and filtering of the signal acquired from the sensor to make it suitable for display General categories
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)
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 5
Units of Measurement
Fundamental SI units
SI = Systemes Internationales dUnites
Derived SI units
source: A. Morris, Principles of Instrumentation and Measurement, 3rd Ed., Butterworth-Heinemann, 2001. ECE 445: Biomedical Instrumentation Ch1 Basics. p. 6
Units of Measurement
Unit Definitions
source: A. Morris, Principles of Instrumentation and Measurement, 3rd Ed., Butterworth-Heinemann, 2001. ECE 445: Biomedical Instrumentation Ch1 Basics. p. 7
BI = biomedical instrumentation
BI Operational Modes
Direct vs. Indirect
Direct mode: measure desired measurand directly
if the sensor is invasive, direct contact with the measurand is possible but expensive, risky and least acceptable
Indirect mode: measure a quantity that is accessible and related to the desired measurand
assumption: the relationship between the measurands is already known often chosen when the measurand requires invasive procedures to measure directly
Example indirect mode
Cardiac output (volume of blood pumped per minute by the heart)
can be determined from measurement of respiration, blood gas concentration & dye dilution
Organ morphology
can be determined from x-ray shadows
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 8
BI Operational Modes
Sampling vs. Continuous mode
Sampling: for slow varying measurands that are sensed infrequently
like body temperature & ion concentrations
Continuous: for critical measurements requiring constant monitoring
like electro-cardiogram and respiratory gas flow
Generating vs. Modulating
Generating: also known as self-powered mode
derive their operational energy from the measurand itself Example: piezoelectric sensors, solar cells
Modulating: measurand modulates the electrical signal which is supplied externally
modulation affects output of the sensor Example: photoconductive or piezoresistive sensor
ECE 445: Biomedical Instrumentation
Ch1 Basics. p. 9
BI Operational Modes
Analog vs. digital modes
most sensors are inherently analog
(some optical sensors are exceptions)
require analog-to-digital converters before any DSP techniques could be applied for filtering
Real-time vs. Delayed-time mode
Real-time
Example: ECG signals need to measured in real-time to determine an impending cardiac arrest
Delayed-time
Example: cell cultures which requires several days before any output is acquired
ECE 445: Biomedical Instrumentation
Ch1 Basics. p. 10
Measurement Constraints
The signal to be measured imposes constraints on how it should be acquired and processed Signal/frequency ranges
Most medical measurands parameters are typically much lower than conventional sensing parameters (microvolts, mm Hg, low frequency)
Interference and cross-talk
Noise from environment, instruments, etc. Other measurands affect measurement (and cant be isolated)
e.g., Cannot measure EEG without interference from EMG
Require filtering and/or compensation
Placement of sensor(s) in/on/near the body plays a key role in any bio-instrumentation design
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 11
Measurement Constraints
Measurement variability is inherent at molecular, organ and body level
Primary cause
interaction between different physiological systems existence of numerous feedback loops whose properties are poorly understood
Therefore evaluation of biomedical devices rely on probabilistic/statistical methods (biostatistics) 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 many cases, safe levels of energy is difficult to establish Safety of medical personnel also must be considered
Operator constraints
Reliable, easy to operate, rugged and durable
ECE 445: Biomedical Instrumentation
Ch1 Basics. p. 12
Classification of biomedical instruments
Quantity being sensed
pressure, flow or temperature makes comparison of different technologies easy resistive, inductive, capacitive, ultrasonic or electrochemical makes development of new applications easy cardiovascular, pulmonary, nervous, endocrine isolates all important measurements for specialists who need to know about a specific area
Principle of transduction
Organ systems
Clinical specialties
pediatrics, obstetrics, cardiology or radiology easy for medical personnel interested in specialized equipment.
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 13
Measurement Input Sources
Desired inputs Interfering inputs
measurands that the instrument is designed to isolate quantities that inadvertently affect the instrument as a consequence of the principles used to acquire and process the desired inputs undesired quantities that indirectly affect the output by altering the performance of the instrument itself
Interfering Inputs Instrument Measurand
Modifying inputs
ECG example Desired input ECG voltage Interfering input 60 Hz noise voltage, displacement currents Modifying input orientation of the patient cables
Modifying Inputs
when the plane of the cable is perpendicular to the magnetic field the magnetic interference is maximal
Interfering inputs generally not correlated to measurand Modifying inputs may be correlated to the measurand
more difficult to remove often easy to remove/cancel
ECE 445: Biomedical Instrumentation
Ch1 Basics. p. 14
Design Criteria and Process
Signal Factors
Sensitivity Range Differential or single ended Input Impedance Transient and frequency response Accuracy Linearity Reliability Specificity Signal-to-noise ratio stability: temperature, Humidity, pressure, Shock, vibration, Radiation Power requirements, Mounting size, shape Invasive or non-invasive Tissue-sensor Interface requirements Material toxicity Electrical safety, Radiation and heat dissipation, Patient discomfort Cost, Availability, Warranty, Consumable requirements, Compatibility with Existing equipment Initial Instrument Design
Prototype Tests
Environmental Factors Measurand
Final Instrument Design
Medical Factors
FDA approval
Production
Economic Factors
Regulation of Medical Devices <OPTIONAL>
Regulatory division of medical devices: class I, II and III
more regulation for devices that pose greater risk
Class I (General controls)
Manufacturers are required to perform registration, premarketing notification, record keeping, labeling, reporting of adverse experiences and good manufacturing practices
Class II (Performance standards)
800 standards needed to be met
Class III (Premarketing approval )
Manufacturers have to prove the safety of these devices prior to market release
Implanted devices (pacemakers etc.) are typically designated class III Investigational devices are typically exempt
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 16
Compensation Techniques
Compensation: elimination or reduction of interfering and modifying inputs Techniques
Altering the design of essential instrument components
simple to implement
Adding new components to offset the undesired inputs
Methods
Reduce sensitivity to interfering and modifying inputs
Example: use twisted cables and reduce number of electrical loops
Signal Filtering
temporal, frequency and spatial separation of signal from noise
ECE 445: Biomedical Instrumentation
Ch1 Basics. p. 17
Compensation: Negative Feedback
When modifying input cannot be avoided, negative feedback is used to make the output less dependent on the transfer function of the device
Amplifier
Vin
Feedback
Vout
Feedback devices must be accurate and linear
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 18
Feedback
Open loop amplifiers are seldom used for precise amplification Using feedback generates precision amplifiers
R2
VX
R1
-
Vin VX VX Vout = R1 R2
Vin
Vout = A(Vref VX )
Vout
Vout R2 Vin R1 = 1 R2 [1 + (1 + )] A R1
Vref
For a large open-loop gain
R2 A >> (1 + ) R1
Vout =
R2 Vin R1
closed-loop gain
Ch1 Basics. p. 19
ECE 445: Biomedical Instrumentation
Feedback II
Large open loop gain criterion
easy to satisfy
R2 A >> (1 + ) R1
Vout = Vin
Irrespective of the open loop gain A, closed loop gain can be set to almost any value R2
e.g., 100, 200 or 1000
R1
Easy to design amplifiers with high gain
precision not required
Linearity and precision of closed loop amp
determined by ratio of resistors
R2
-
R1
Vin
Vref
ECE 445: Biomedical Instrumentation
Vout
Ch1 Basics. p. 20
Other Compensation Techniques
Opposing inputs or noise cancellation When interfering and modifying inputs cannot be filtered
additional inputs can be used to cancel undesired output components similar to differential signal representation
Next Lecture Topics Biostatistics
statistics terms and definitions biomedical studies
Instrumentation characteristics
static dynamic
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 21
Biostatistics
Used to design experiments and clinical studies:
To summarize, explore, analyze and present data To draw inferences from data by estimation or by 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.
ECE 445: Biomedical Instrumentation
Ch1 Basics. p. 22
Biostatistics Studies
Observational studies case-series studies
Case-control studies
use of individuals selected because they have some outcome or disease then look backward to determine possible causes
Cross-sectional studies:
Analyze characteristics of patients at one particular time to determine the status of a disease or condition.
Cohort observational studies:
A particular characteristics is a precursor for an outcome or disease
Controlled studies:
If procedures compared to the outcome for patients given a placebo or other accepted treatment
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 23
Biostatistics Studies II
Concurrent control:
Patients are selected in the same way and for the same duration
Double-blind study:
Randomized selection of patients to treatment options to minimize investigator or patient bias
ECE 445: Biomedical Instrumentation
Ch1 Basics. p. 24
Biostatistics: Data Analysis
Distributions of data reflect the values of a variable/characteristic and frequency of occurrence of those values
Mean: (X )average of N values (arithmetic or geometric mean) Xi Median: middle of ranked values GM = N X 1 X 2 ... X N X = i Mode: most frequent value N Standard deviation: (s) spread of data
75% of values lie between X 2 s
s=
(X
i
N 1
Coefficient of Variation: (CV)
permits comparison of different scales
s CV = 100% X
Percentile
Percentage of distribution that is less than or equal to the percentile number
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 25
More Biostatistics
Correlation coefficient (r)
r= Measure of the relationship between two Xi X numerical variables for paired observations values between +1 and -1 (+1 means strong correlation)
(X
X Yi Y
)(
(Y Y )
i
Estimation and Hypothesis Testing
Confidence intervals Hypothesis testing P-value:
indicates the degree of confidence that data contains the true mean reveals whether the sample gives enough evidence for us to reject the null hypothesis (statement expressing the opposite of what we think is true) how often the observed difference would occur by chance alone
Methods for measuring the accuracy of a diagnostic procedure:
opposite: false-negative rate opposite: false-positive rate
Sensitivity: probability of the test yielding positive results in patients who actually have the disease Specificity: probability of the test yielding negative results in patients who do not have the disease
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 26
Instrument Characterization
Enable comparison of available instruments Permit evaluation of new instrument designs Generalized static characteristics Static characteristics:
performance of instruments for dc or very low frequency inputs some sensors respond only to time-varying inputs and have no static characteristics
Dynamic characteristics:
require temporal relationships to describe the quality of measurements
ECE 445: Biomedical Instrumentation
Ch1 Basics. p. 27
Static Characteristics
Accuracy
Difference between the true value and the measured value normalized by the magnitude of the true value Several ways to express accuracy
most popular is in terms of percentage of full-scale measurement
Precision
Expresses number of distinguishable alternatives from which a given result is selected High-precision does not mean high accuracy. Smallest incremental quantity that can be measured with certainty Ability of an instrument to give the same output for equal inputs applied over some period of time
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 28
Resolution
Reproducibility
Statistical Control and Static Sensitivity
Measurement conditions have to take into account randomness introduced by environmental conditions Statistic sensitivity (dc-gain)
To perform calibration between output and input For linear calibration If the source of variation can not be removed, then use averaging
n xd y xd y d d m= d 2 2 xd n xd d d
2 y xd xd y xd d d b = d d 2 2 xd n xd d d
y = mxd + b
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 29
Static Characteristics
static sensitivity curves
Zero drift (offset error)
Sensitivity drift (gain error)
When all measurements increases or decrease by the same absolute amount Causes: manufacturing misalignment, variations in ambient temperature, hysteresis vibration, shock, dc-offset voltage at electrodes When the slope of the calibration curve changes as a result of interfering or modifying input Causes: manufacturing tolerances, variations in power supply, non-linearity Example: ECG amplifier gain changes due to dc power-supply variation
ECE 445: Biomedical Instrumentation
Ch1 Basics. p. 30
Linearity
Linearity (formally) : A system that demonstrates superposition principle
If system inputs x1, x2 generate outputs y1, y2,
i.e., (x1 y1 AND x2 y2)
Then system is linear if (x1 + x2 y1 + y2) AND (Kx1 Ky1)
Linearity (informally): Output is linearly proportional to measurand quantity
data is fit to linear curve, generally using least-squares technique
outputs, yi linear fit, zi minimize (zi yi)2
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
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 31
Dynamic Characteristics <OPTIONAL>
Quantify response of medical equipment with respect to timevarying inputs Many engineering instruments can be described by ordinary linear differential equations
dx dny dy d mx an n + ... + a1 + a0 y (t ) = bm m + ... + b1 + b0 x(t ) dt dt dt dt
Most practical instruments have a first or second order response Practical evaluation of a system
Apply input as a unit-step function, sinusoidal function or white noise
ECE 445: Biomedical Instrumentation
Ch1 Basics. p. 32
Dynamic Characteristics
Operational transfer function:
bn s n + ... + b1s + b0 Y (s) = H (s) = X ( s ) am s m + ... + a1s + a0
Frequency response of a system For a sinusoidal input
the output is a sinusoid with different magnitude and phase
s = j
H ( s ) = K H1 ( s )...H m ( s )
Magnitude: Phase:
| H ( s ) |= K | H1 ( s ) | ... | H m ( s ) | H ( s ) = H1 ( s ) + ... + H m ( s )
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 33
Zero-order Instrument
a0 y (t ) = b0 x(t )
Y ( s ) b0 H (s) = = X ( s ) a0
Linear potentiometer is an example of a zero order instrument In practice, at high frequencies parasitic capacitance and inductance will cause distortion Step response is proportional to the input amplitude; no variation with frequency
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 34
First-order Instrument
First-order instrument contains a single energy-storage element
dy a1 + a0 y (t ) = b0 x(t ) dt
Y (s) K = H (s) = X ( s ) (1 + s )
K = b 0 / a 0 is the static sensitivity (dc-gain) = a1 / a 0 is the time-constant of the system
Step response is characterized by a single time constant
A frequency transfer function is given by
| H ( j ) |=
K 1 + 2 2
H ( j ) = arctan( )
Ch1 Basics. p. 35
ECE 445: Biomedical Instrumentation
Second-order Instrument
Second-order instrument contains a minimum of two energy-storage element.
dy d y a2 2 + a1 + a0 y (t ) = b0 x(t ) dt dt
where
H (s) = (1 +
K 2s
s2
2 0
K = b0 / a 0
is the static sensitivity (dc-gain) Step response is characterized by
a0 0 = a2
=
a1 2 a0 a 2
is the undamped natural frequency
undamped natural frequency and the damping ratio
is the damping ratio
ECE 445: Biomedical Instrumentation Ch1 Basics. p. 36
1st & 2nd order Instruments
ECE 445: Biomedical Instrumentation
Ch1 Basics. p. 37
