Biological Amplifiers

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Electrical safety
Bio-Amplifiers
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DEF: A Bio-amplifier is a device used to gather and increase the signal
integrity of human neurophysiologic electrical activity for output to
various sources.
BASIC REQUIREMENT FOR BIOLOGICAL AMPLIFIERS:
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Bio-Amplifiers must have high input impedance.
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It must have isolation and protection circuits.
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Voltage gain of bio-amplifiers should be more than 100db.
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Constant gain should be maintained throughout the required
bandwidth.
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Drift free amplifiers can acts as good bio-amplifiers.
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CMRR of bio-amplifiers should be more than 80db.
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Medical amplifiers designed for use in the input stage (preamplifiers)
are mostly of the differential type.
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These type have three input terminals out of which one is arranged at
the reference potential and the other two are live terminals.
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The differential amplifier is employed when it is necessary to measure
the voltage difference between two points, both of them varying in
amplitude at different rates and in different patterns.
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Heart-generated voltages picked up by means of electrodes on the arms
and legs, and brain-generated voltages picked up by the electrodes on
the scalp are typical examples of signals whose measurement requires
the use of differential amplifiers.
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The differential amplifier is an excellent device for use in the recording
systems.
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Its excellence lies in its ability to reject common-mode interference
signals which are invariably picked up by electrodes from the body
along with the useful bioelectric signals.
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Also, as a direct coupled amplifier, it has good stability and versatility.
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High stability is achieved because it can be insensitive to temperature
changes which is often the source of excessive drift in other
configurations.
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It is versatile in that it may be adapted for a good many applications,
e.g. applications requiring floating inputs and outputs or for
applications where grounded inputs and/or outputs are desirable.
 Differential amplifier
Single ended amplifier

Typical differential amplifier configuration

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A differential amplifier, which is a circuit that amplifies the difference
between two signals.
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The differential amplifier is a voltage subtractor circuit which
produces an output voltage proportional to the voltage difference of
two input signals applied to the inputs of the inverting and non-
inverting terminals of an operational amplifier.
Instrumentation Amplifier
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The differential amplifier is well suited for most of the applications in
biomedical measurements.
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However, it has the following limitations:
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The amplifier has a limited input impedance and therefore, draws
some current from the signal source and loads them to some extent.
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The CMRR of the amplifier may not exceed 60 dB in most of the cases,
which is usually inadequate in modern biomedical instrumentation
systems.
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These limitations have been overcome with the availability of an
improved version of the differential amplifier
Instrumentation amplifier
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An instrumentation amplifier is a precision differential voltage gain
device that is optimized for operation in an environment hostile to
precision measurement.
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It basically consists of three op-amps and seven resistors.
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Basically, connecting a buffered amplifier to a basic differential
amplifier makes an instrumentation amplifier.

Advantages:
High gain
Extremely high input impedance
CMRR is good.
Chopper Amplifiers
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The chopper amplifier is a useful device in the field of medical electronics
as it gives another solution to the problem of achieving adequate low
frequency response while avoiding the drift problem inherent in direct
coupled amplifiers.
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This type of amplifier makes use of a chopping device, which converts a
slowly varying direct current to an alternating form with amplitude
proportional to the input direct current and with phase dependent on the
polarity of the original signal.
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The alternating voltage is then amplified by a conventional ac amplifier
whose output is rectified back to get an amplified direct current.
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A chopper amplifier is an excellent device for signals of narrow
bandwidth and reduces the drift problem.
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Analog signal is sampled in this amplifier circuit. Hence this circuit is
known as chopper amplifier.
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Chopper amplifiers are classified into mechanical and non-mechanical
choppers.

Advantages:
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Stable gain
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Provides low noise operation
Isolation Amplifier
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Isolation amplifiers are commonly used for providing protection
against leakage currents.
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They break the ohmic continuity of electric signals between the input
and output of the amplifier.
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The isolation includes different supply voltage sources and different
grounds on each side of the isolation barrier.
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Three methods are used in the design of isolation amplifiers: (i)
transformer isolation (ii) optical isolation (iii) capacitive isolation.
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The transformer approach uses either a frequency-modulated or a
pulsewidth- modulated carrier signal with small signal bandwidths up
to 30 kHz to carry the signal.
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It uses an internal dc–to-dc converter comprising of a 20 kHz
oscillator, transformer, rectifier and filter to supply isolated power.
Isolation amplifier (transformer type)
Optical Isolation
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From the above diagram, as the input signal varies, the light intensity
of the LED shown in the last stage of amplification also varies.
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An opto-coupler is used to couple this light to the phototransistor.
This light falls on a phototransistor.
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The collector current of the phototransistor is proportional to the
light intensity.
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For stabilization purposes, a feedback from the output may be
provided.
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Isolation could also be achieved by optical means in which the patient
is electrically connected with neither the hospital line nor the ground
line.
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A separate battery operated circuit supplies power to the patient
circuit and the signal of interest is converted into light by a light
source (LED).
Advantages:
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Isolation amplifiers withstand high voltage.
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It amplifies the signals while passing only low leakage current to
prevent shock.
ELECTRICAL SAFETY
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Whenever a person is connected to an electrical device by a grounded
conductive pathway that is low resistance, such as through bio-
potential electrodes, there is a concern about electrical safety.
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Electric voltages that ordinarily would be harmless to casual skin
contact can become dangerous or even lethal if someone happens to
be well grounded.
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Electric shock hazard is particularly a concern in clinical bio-potential
monitoring where the patient may be in a vulnerable state of health.
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Bio-electrodes are desirably low-resistance connections to the body
for amplifier performance reasons.
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These fault currents could arise from many sources, including within
the amplifier itself through some internal failure of its insulation or
from a patient coming into contact with defective electric devices in
the immediate environment.
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These might include such things as a table lamp, a reclining bed
controller, electric hand appliances (e.g., hair dryers), and computers,
radios, television sets, etc.
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All have potential failure modes that can place the hot lead of the
power main to the frame or case of the device.
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Current flows of about 6 mA or greater at line frequencies cause
muscle paralysis, and the person may be in serious straits indeed and
unable to let go.
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In some failure modes, the device can still appear to function quite
normally.
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Ground-Fault Circuit Interrupters. Commercial ground-fault circuit
interrupters (GFCIs) detect unbalanced current flows between the hot
and neutral sides of a power line.
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Small fault current flows through a person’s body to ground will trip a
GFCI circuit breaker, but large currents through a normally functioning
appliance will not.
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Building codes for power outlets near water in many countries now
requires these devices. GFCI devices can significantly increase safety
when used with bioinstrumentation.
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These devices are often incorporated into the wall socket itself and
can be identified since they usually show a red test-reset button near
the electrical socket.
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Isolation Amplifiers. Isolation amplifiers increase safety by preventing
fault currents from flowing through the body by way of a ground-
referenced bio-potential electrode.
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Isolation amplifiers effectively create an electric system similar to
biotelemetry.
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They eliminate any significant resistive coupling between the isolated
front-end stages of the amplifier and the output stages to the
recorder.
ELECTRICAL SAFETY TESTING
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Manufacturers of medical equipment ensure that all safety
regulations during the design and manufacture are complied with and
a safe equipment has been produced.
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Now it is the task of the hospital (hospital workshop) to ensure that
the equipment remains safe during usage.
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Electrical safety tests are compulsory after every repair of a medical
equipment and are furthermore, part of the preventive maintenance
procedure (PPM).
Visual inspection
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Every safety test should start with a visual check of the equipment
and its power supply.
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Is the wall socket in good working order or is it damaged?
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Is the power plug OK and of the correct system?
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Are the contacts clean or are they charred?
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Is the power cable damaged? Brittle and patched power cables have
to be replaced.
A simple visual inspection of the inside of the equipment:
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Does the equipment show signs of overheating and burns?
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Are all cable connections tight? Look out for loose cables.
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Are there any bare wires?
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Are the fuses correct? Bypassed fuses have to be removed
immediately.
Electrical safety test procedures
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After testing all test results should be documented on a test report.
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Tested equipment should get a sticker which shows the user that the
equipment is safe and the date of the next test.
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An equipment with a results beyond the value limit must not be used
again until the fault has been rectified.
These electrical safety tests are described in the following:
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Protective earth continuity test
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Insulation resistance test
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Earth leakage current test
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Touch current / Enclosure leakage current test
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Patient leakage current test
Protective earth continuity test (Class I)
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With this test the resistance of the PE conductor is measured
between the PE connection of the mains plug and the unpainted
metal housing of the equipment.
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This is the most important test and we should always start safety tests
with this one.
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If an equipment fails this test it will also fail the other tests.
Continuity tester is connected to the metal housing of the equipment and to PE of the mains plug.
Equipment is switched on.
The resistance should be ≤ 0.2 Ω
Insulation resistance test (Class I)
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With this test the insulation is measured. Therefore an insulation or
safety tester (e.g. Megger) is needed. The tester delivers a high DC
voltage to the equipment under test and then the resistance of the
insulation in between is measured.
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Standard test voltage for electrical equipment is 500 V. Electronic and
medical equipment which often contain voltage limiting devices such
as MOV or EMI-filters should be tested at 250 V.
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The tester is connected between the mains plug with L and N
connected together and PE.
Equipment is disconnected from mains.
Equipment is switched on.
Insulation tester is connected between L+N and PE.
The resistance should be ≥ 2 MΩ (medical equipment)
≥ 1 MΩ (on electric motor), ≥ 0.3 MΩ (on equipment with heating element)
Insulation resistance test (Class II)
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The insulation resistance test for Class II equipment is different
because the mains plug has no PE connection.
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The insulation resistance is measured between the patient cables
which are all connected together and exposed and unpainted metal
pieces (e.g. screws, sockets) of the equipment.
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Standard test voltage for electrical equipment is 500 V.
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Electronic and medical equipment which often contain voltage
limiting devices should be tested at 250 V.
Equipment is disconnected from mains.
Equipment is switched off.
Insulation tester is connected between all patient cables and exposed metal pieces.
The resistance should be ≥ 2 MΩ
Leakage current test device
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The leakage current through a human body can be simulated and
determined by inserting a known impedance into the ground
connection and then measuring the voltage drop across it.
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The recommended measuring device consists of a 1 kΩ resistor and a
capacitor of 0.15 µF in parallel.
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The voltmeter has to have at least 1 MΩ impedance, so it has to be a
digital one.
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Leakage current tests with such a test device are standard test
procedures for medical equipment and are recommended by almost
all medical equipment manufacturers.
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The displayed measurement result in mV is equal to a current in µA (1
mV ≙ 1 µA).
The following three different leakage current measurements should be made, each under two conditions: Normal
condition (NC) and single fault condition (SFC), when the earth or neutral connection is interrupted.
Earth leakage current
Touch current (enclosure leakage current)
Patient leakage current
Earth leakage current test (Class I)
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This test simulates and measures a leakage current through the
ground wire to earth. The test is done in normal operation mode and
in single fault condition (open neutral).
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The measurement of the leakage current can be used as a substitute
for the insulation resistance test (2a).
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In fact it is even better do this test instead because the high voltage of
the insulation test may cause damages to the equipment on test
when MOVs and Y-capacitors of EMI-filters are present.
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The equipment under test has to be switched on.
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The measurement should be done with normal mains polarity and in
reverse.
Normal condition
Equipment is switched on.
Normal polarity
Reverse polarity
Leakage current should be ≤ 0.5 mA (B, BF, CF)
Touch current / Enclosure leakage current (Class I and Class II)
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This test simulates and measures a leakage current through the
exposed conductive surface to earth.
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The test is done in normal operation mode and in single fault
condition (open neutral, open PE).
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The equipment under test has to be switched on. The measurement
should be done with normal mains polarity and in reverse.
Normal condition
Equipment is switched on.
Normal polarity.
Reverse polarity.
Leakage current should be ≤ 0.1 mA (B, BF, CF)
Patient leakage current (Class I and Class II)
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This test simulates and measures a leakage current through the
patient connections to earth. The test is done in normal operation
mode and in single fault condition (open neutral, open PE).
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The equipment under test has to be switched on. The measurement
should be done with normal mains polarity and reverse.
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The patient leads of B and BF equipment are connected together and
are then measured against earth.
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In case of an equipment of CF type the currents should be measured
separately, through each patient connection to earth.
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The equipment under test has to be switched on. The measurement
should be done with normal mains polarity and in reverse.
Normal condition
Equipment is switched on.
Normal polarity.
Reverse polarity.
Leakage current should be ≤ 0.1 mA (B, BF) ≤ 0.01 mA (CF)
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