Patient Safety Theory

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(BMI-252)Patient safety & ultrasound & Radiation Physics Theory

01 The importance of Patient safety

1.1 Define the patient safety against the electricity

Safety: freedom from unacceptable risk of harm.

Basic Safety: Protection against direct physical hazards when medical electrical equipment is used under normal or other
reasonably foreseeable conditions.

Hazard: A situation of potential harm to people or property.

Risk: The probable rate of occurrence of a hazard causing harm and the degree of severity of the harm.

Effeciveness: the ability of an item to meet a service demand of given quantitative characteristics.

Safety Integrity Level: A qualitative measure of the level of assurance that a component or system will function as intended
or, if it malfunctions, will do so in a safe manner

Patient safety: is a new healthcare discipline that emphasizes the reporting, analysis, and prevention of medical error that
often leads to adverse healthcare events.

Electrical safety is contaminated or limitation of hazards electrical shocks explosion, fire, or damage to equipment and
buildings.

Electrical shock refers to both Macro shock (high value, arm to arm current ultimately passing through the heart) and micro
shock (low value current, passing directly through the heart).Shock may occur to patient, employees and visitors to a hospital
or health care facility. Shock results from improperly wired or maintained electrical equipment or power systems.

Explosion may result from electrical contact sparks that ignite a variety of explosion, gases, such as either or cyclo propane
anesthetic.

Fire may result from heat produced by overloaded, incorrectly wired, or improperly maintained equipment or power systems.

Damage to equipment and buildings may result from explosion, fire, or electrical over load.

Safety may be defined as the condition of being safe from hurt, injury, loss.

Actually, safety is often referred to as a situation that is harmless. However, in reality, no situation can be rendered completely
safe .as such electrical safety in the medical environment refers only to the limitation of hazards situation.

In the practical daily routine of hospital life, it is important to remember that electrical safety is not so much a static state as it is
a dynamic, continuous course of action involving hazard detection and correction.

Types of Hazards

Electrical hazards
Electrical shocks (micro and macro) due to equipment failure, failure of power delivery systems, ground failures, burns, fire, etc.

Mechanical hazards
mobility aids, transfer devices, prosthetic devices, mechanical assist devices, patient support devices
Environmental hazards
Solid wastes, noise, utilities (natural gas), building structures, etc.

Biological hazards
Infection control, viral outbreak, isolation, decontamination, sterilization, waste disposal issues

Radiation hazards
Use of radioactive materials, radiation devices (MRI, CT, PET), exposure control

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1.2 Define the Micro shock
Micro shock is defined as a low value current passing directly through the heart of a cauterized patient, causing ventricular
fibrillation(Ventricular fibrillation (V-fib or VF) is a condition in which there is uncoordinated contraction of the cardiac muscle of
the ventricles in the heart, making them quiver rather than contract properly.) and possible death.
Let us define each of these terms .Micro shock current usually results from the leakage current. Leakage current passes from
an equipment metal chassis to earth ground.

A Catheter is plastic tube inserted into an artery or vein to measure blood pressure flow, to inject substances into blood stream,
or to electrically pace the heart. Ventricular fibrillation is a condition of the heart in which the myocardium vibrates and quivers
instead of pumping steadily and rhythmically. Unless corrected naturally by the patient or artificially by defibrillator unit .V-Fib
results in death due to inadequate blood circulation.

This potentially lethal micro shock hazard causes physicians, Nurses, biomedical engineers, technicians, administrator,
lawyers, patients, and others to be closely concerned with hospital electrical safety

1.3 Define the Macro shock


Macro shock is high value current which passes through the limbs of the human body when they are in contact with the voltage
source, it usually has a range in milli Ampere and Ampere ranges. In Macro shock subject has 2 point of contacts of human
body, in macro shock if the current passing through the heart ventricular fibrillation can be easily occurred which result in death
of patients.
Notes: lethalness of current depends upon the following but not limited to.
1-Amount of current passing through the Body.
2- Current Entry and Exit Points in Human Body.
3-Surface Area of the Body from which Current is passing.
4- Resistance of the Human Body.
5.Time period of electrocution.
Regardless of the above said points, we should assume that small amount current is lethal while working in the field
and safety precaution should be taken on serious note.

Effects of 60 Hz Electric Shock(Current) on Human Body on an Average Human Body

Current Intensity Effect


in Contact
1 S Contact
1mA Threshold of Perception
5mA Accepted as harmless Current Intensity
10-20mA “Let-go” Current before sustained Muscular Contraction
50mA Pain Possible ,Fatigue, Exhaustion, Mechanical injury ,Heart and Respiratory
Function Continue
!00-300mA Ventricular fibrillation will starts but Respiratory Centre intact
6A Sustained Myocardial Contraction followed by normal heart Rhythm, Temporary
respiratory paralysis, Burn if current density is high.

Threshold of Perception: Bruner (1967) states that the threshold of perception of electric shock is about 1 mA. At this level, a
tingling sensation is felt by the subject when there is a contact with an electrified object through the intact skin. The threshold
varies considerably among individuals and with the measurement conditions. The lowest threshold could be 0.5 mA when the
skin is moistened at 50 Hz. Threshold for dc current are 2 to 10 mA.

Let-go Current: As the magnitude of the alternating current is increased, the sensation of tingling gives way to the contraction
of muscles. The muscular contractions increase as the current is increased and finally a value of current is reached at which the
subject cannot release his grip on the current carrying conductor. The maximum current at which the subject is still capable of
releasing a conductor by using muscles directly stimulated by that current is called “let-go current”. The value of this current is
significant because an individual can withstand, without serious after-effects, repeated exposure to his ‘let-go current’ for at least
the time required for him to release the conductor. Currents even slightly in excess of the ‘let-go current’ would not permit
the individual to release his grip from the conductor supplying current.
Experiments conducted by Lee (1966) on 124 males and 28 females reveal that the average value of the ‘let-go current’ for males
was 16 mA and for females it was 10.5 mA. Based on these experiments, it is generally accepted that the safe ‘let-go current’
could be taken to be approximately 9 and 6 mA for men and women respectively.

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Physical Injury and Pain: At current levels higher than the ‘let-go current’, the subject loses the ability to control his own muscle
actions and he is unable to release his grip on the electrical conductor. Such currents are very painful and hard to bear. This type
of accident is called the ‘hold-on-type’ accident, and is caused by currents in the range of 20–100 mA. These currents may also
result in physical injury because of the powerful contraction of the skeletal muscles. However, the heart and respiratory functions
usually continue because of the uniform spread of current through the trunk of the body. Strong involuntary contractions of the
muscles and stimulation of the nerves can be painful and cause fatigue if there is long exposure.

Ventricular Fibrillation: If current comes in contact with intact skin and passes through the trunk at about 100 mA and above,
there is a likelihood of pulling the heart into ventricular fibrillation. In this condition, the rhythmic action of the heart ceases,
pumping action stops and the pulse disappears. Ventricular fibrillation occurs due to the derangement of function of the heart
muscles rather than any actual physical damage to it. Ventricular fibrillation is a serious cardiac emergency because once it
starts, it practically never stops spontaneously, even when the current that triggered it is removed. It proves fatal unless corrected
within minutes, since the brain begins to die 2 to 4 min after it is robbed of its supply of oxygenated blood. Obviously, experiments
involving currents likely to cause ventricular fibrillation cannot be performed on human beings. They have been
performed on a variety of animals and relationships have been determined between fibrillating currents versus body weight,
current magnitude and shock duration.

Sustained Myocardial Contraction: At currents in the range of 1 to 6 A, the entire heart muscle contracts. Although the heart
stops beating while the current is applied, it may revert to a normal rhythm if the current is discontinued in time, just as in
defibrillation. The damage is reversible if the shock duration is only of a few seconds. This condition may however be
accompanied by respiratory paralysis.

Burns and Physical Injury: At very high currents of the order of 6 amperes and above, there is a danger of temporary respiratory
paralysis and also of serious burns. Resistive heating causes burns, usually on the skin at the entry points, because skin
resistance is high. Voltages higher than 230 V can puncture the skin. The brain and other nervous tissue loose all functional
excitability when high currents pass through them. However, even in this case, if the shock duration is only of
a few seconds, there is a possibility, of the heart reverting to the normal rhythmic action. The defibrillators are based for their
effectiveness on this phenomenon.

The threshold of perception depends greatly on the current density in the body tissues. It may vary widely depending upon the
size of the current contact. At a very small point contact, it is probable that even 0.3 mA current may be felt whereas a current in
excess of perhaps 1 mA may not produce a sensation if the contacts are somewhat larger. Similarly, depending on the size of
contact, the threshold of pain may also be considerably above 1 mA; probably 10 mA if the contacts are large enough. Besides
the magnitude of current, the current duration and the relationship of current flow resistance are also important. Duration of less
than 10 ms typically does not produce fibrillation whereas a duration of 0.1 s or longer does. Outside the medical practice, a
general limit of 500 mA is established for currents passing through the body. This is intended as a guide to acceptable leakage
current levels because a current of this magnitude may give a tingling sensation, which can be disagreeable over a long period.
The International Electrotechnical Commission, therefore, recommends that for medical
equipment the current flowing continuously through the body should not exceed 100 mA within a frequency range of 0 to 1 kHz.
In case of abnormal situations (e.g. in the case of equipment failure), the recommended maximum current is 500 mA for
frequencies up to 1 kHz. Above 1 kHz, the recommended maximum increases proportionally with frequency

Gross shock hazards are usually caused by electrical wiring failures, which allow personal contact with a live wire or surface at
the power line voltage. This type of hazard is dangerous not only to the patient but also to the medical and attending staff. The
most vulnerable part in the system of electrical safety is the cord and plug. Physical abuse and deterioration are so common
that human perception is blunted and faulty cords and plugs are continued in use. Their use can result in fatal accidents. Broken
plugs, faulty sockets and defective power cords must be immediately replaced.
The commonly found fluids in medical practice such as blood, urine, intravenous solutions, etc. can conduct enough electricity
to cause temporary short circuits if they are accidentally spilled into normally safe equipment. This hazard is particularly more in
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hospital areas that are normally subject to wet conditions, such as haemodialysis and physical therapy areas. The cabinets of
many electrically operated equipment have holes and vents for cooling that provide access for spilled conductive fluids, which
can cause potential electric shock hazard.

Whalen and Starmer (1967) have published comprehensive data on shock hazards arising from polarity reversal or wiring errors.
The frequency with which such errors create hazards has prompted the designing of many testers for checking outlets or
appliances. The cords of the instruments must be limited in length as the leakage current is a function of the length. The length
should be standardized, say at 3 m. This should be shielded and a low dielectric loss insulation be used. Extension cords
introduce needless risk. They should be avoided as far as possible.

1.4 Describe the effects of micro current passing through the myocardium.

Myocardium: the muscular tissue of the heart.

Electric current passing through the heart can be more dangerous because it effects on the circulatory system (Cardio
pulmonary) of the human body.

Human heart has rhythmic and sequential contraction means chamber of heart contract and relaxes at some specific patterns
and sequences, as we know that human muscles including cardiac muscle contracts by getting electric sti muli by the nervous
system, only the human heart has natural Pace Maker (S A Node) which continuously given the electrical pulses to the heart
muscle from the generation of human as a fetus till to death.

The property of human muscle to contract by getting electrical stimuli can react when the human body is electrocuted by the
external current, which means that by the eternal

1.5 Draw the current entry and exit point

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02 The classification of bio medical equipment
2.1 Describe the classification of bio medical equipment.
Classification of medical equipment depends upon many factors, we can classified the equipment with respect to its use
,application, by wards , by its method of protection, degree of protection, protection against of liquid ,protection against of anesthetic
agent, protection against sterilization or decontamination and so on.

Let’s say we can categories the equipment w.r.t of their use like we can categories biomedical equipment which are used for the
cardiac study Like Electro Cardio Graphy , Exercise Tolerance Test and, treadmill , Holter, Patient Monitors, Cardiac Monitors, Echo
Cardiography,Cardio Toco Graph , Fetal Doppler ,defibrillators, Angiography and Cardiac CT scan. All of said equipment have
different working principle and used to diagnose and provide therapy to the heart.

Now we can also categories the medical equipment with respect to wards for example we can enlist the equipment which can be
used in ICU intensive Care Units , Patient Monitors, defibrillators ,Suction Machine, Ventilators , infusion Pump and Syringe Pump.

About said classifications are not authenticated list of the equipment can be changes with the advancement of technology, to
facilitate the patients by providing much more diagnostic tests.
International Electro technical Commission IEC is an organization which classified the M.E on the engineering aspects including
protection of patient and Operators and IEC classification is much more authenticated for study and understanding being as an
engineer.

2.3 classified the BM equipment according to the types of protection against electrical shock

2.4 Define class I equipment

2.5 Define class II equipment

2.6 Define class III equipment

Classification of biomedical equipment is depends upon many factors, including its use, its power rating, its application, its insulation
and grounding (protection) or its degree of protection.
Class I
A Class I equipment has a protective earth connection (PE). This earth connection is connected to all exposed metal parts,
especially to the metal housing. The connected power cable is thus a three core mains cable and the power plug has three pins .

The user is protected by a basic insulation and the


protective earth connection. In the event of a fault when line comes in contact with the metal enclosure the fault current is shortened
to ground, a big short-circuit current flows and the fuse inside the equipment blows or the circuit breaker (MCB) in the distribution
board gets tripped.

Medical equipment should be additionally protected by two internal fuses, one for the line path and one for neutral. In many
countries L and N are not defined and the power plug can be inserted into the wall socket in both ways. Then the neutral fuse which
is theoretically useless becomes the important line fuse. Also, smaller fuses inside the equipment blow faster than a MCB which is
made for higher currents.

The symbol for Class I equipment is the earth sign in a circle which should be imaged on the rating plate. But the use of
this symbol is not mandatory. Many equipment have no symbol. Then it can be considered as Class I.

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Class II
A Class II equipment is double insulated and not earthed Safety is achieved by two (or more) layers of insulating material between
live parts and the user. Earthling is not necessary.
In case of a damage of one insulation the second prevents any external parts from becoming alive.
The Class II equipment is usually connected with a 2-pin plug/cable to mains. But also 3-pin connections can be used. In this case
PE must not connected to the metal housing of the equipment. Class II equipment usually have only one internal fuse.

The symbol for Class II equipment is the double box which should be imaged on the rating plate.

Class III
A Class III equipment is a low-voltage equipment. The voltage is so low (Safety Extra Low Voltage, SELV) that a person who gets in
contact with it does not get an electric shock.
The equipment runs either on battery or on an external power supply which creates a supply voltage of less than 50 VAC. The
testing of Class III equipment is done in conjunction with the power supply tested in Class I or Class II.

The symbol for Class II equipment is the Roman III inside a rhombus which should be imaged on the rating plate.

Isolation transformer
The use of an isolation transformer is not specified in an extra safety class but it is a another possibility of protection. The isolation
transformer is a 1:1 transformer which provides a galvanic isolation from line potential to earth. The output voltage is only presen t
between the two output connectors and no longer from one (line) to ground. The output socket has no PE connection and may onl y
be used for one equipment.
The isolation transformer is used for special equipment in the operating room and in the workshop. Especially in the workshop the
isolation transformer should be always used when working on energized equipment (e.g. switched mode power supplies).

The symbol for a transformer is also find on external power supplies when they contain a transformer.

2.2 classified the BM equipment according to degree of electrical connection between equipment and patient.

Types
The equipment classes define the method of protection against electric shock. For household appliances this is good enough bu t not
for medical equipment.

A medical equipment of one class can be used without a connection to a


human body (e.g. suction pump), with a patient connection (e.g. pulse oximeter) and inside the body of a patient (e.g. electro
surgery unit). That is why the appliance classes are again divided in different types. The types define the degree of protection.
For this reason we find two symbols on the rating plates of medical equipment, one for the method of protection (class) and one for
the degree of protection (type).

Type B
In combination with medical equipment of Class I, II, III.

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Standard degree of protection against electric shock. No electrical contact with a patient. Equipment may be connected to
earth. Patient connections are not conductive and can be immediately released from the patient. Standard values for permitted
leakage currents are demanded which are stated under the respective test procedure.

Type BF
In combination with medical equipment of Class I, II, III.

Equipment is safe for electrical connection to the patient but not directly to the heart. The patient part of the equipment is
isolated (floating circuit) and has to be separated from earth. Standard values for permitted leakage currents are demanded which
are stated under the respective test procedure.

When the equipment can be used in combination with a defibrillator this symbol has to be printed on the rating plate. It
means defibrillation-proof.

Type CF
In combination with medical equipment of Class I, II, and III.

Equipment provides highest degree of protection against electric shock. It is safe for electrical connection to the heart of
the patient. The patient part of the equipment is also isolated (floating circuit) and is separated from earth like BF. The p ermitted
leakage current is much lower than for type B and BF. The values are stated under the respective test procedure.

When the equipment can be used in combination with a defibrillator this symbol has to be printed on the rating plate. It
means defibrillation-proof.

2.7 Classified the BM equipment according to the degree of protection against increase of liquids.

International Electro technical commission (IEC) document No 60529 has given us the division
Of ME with respect to the increase of liquid and vapors. ENCLOSURES shall be classified according to the degree of protection
against harmful ingress of water and particulate matter.

This classification is IPN1N2, where:


– N1 is an integer indicating degree of protection against particulate matter or the letter “X”.
– N2 is an integer indicating the degree of protection against ingress of water or the letter “X”.

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2.8 Classified the BM equipment according to the method of sterilization or disinfection.

ME EQUIPMENT or its parts intended to be sterilized shall be classified according to the


Method of sterilization as:

EXAMPLE 1 By ethylene oxide gas


EXAMPLE 2 By irradiation such as gamma ray
EXAMPLE 3 By moist heat such as by autoclave
EXAMPLE 4 By other methods validated and described by the MANUFACTURER

For ME EQUIPMENT parts or ACCESSORIES that can become contaminated through contact with
the PATIENT or with body fluids or expired gases during NORMAL USE, the instructions for use
shall contain:
– details about cleaning and disinfection or sterilization methods that may be used; and
– list the applicable parameters such as temperature, pressure, humidity, time limits and
number of cycles that such ME EQUIPMENT parts or ACCESSORIES can tolerate.

This requirement does not apply to any material, component, ACCESSORY or ME EQUIPMENT
that is marked as intended for a single use unless the MANUFACTURER specifies that the
material, component, ACCESSORY or ME EQUIPMENT is to be cleaned, disinfected or sterilized

2.9 Classified the BM equipment according to Anesthesia and flammable cleaning agents

2.10 Classified the BM equipment according to mode of operation.

03 The higher frequency current effects on the human body

3.1 Define higher frequency current


High frequency current is that current which has a frequency from 10,000 hz to 200KHz ,this current is also called the Tesla current.

3.2 Describe the physiological effects of electrical current on Patient.


 In house electrical supplies have 220 V AC with 60 Hz of Frequency.
 Human body has the following mentioned effects with the supply of 60Hz
 Injury to tissue ,due to heat energy
 Uncontrollable Muscle Contraction or unconsciousness
 Ventricular fibrillation

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 All of the above said effects are due to the frequency of the 60 Hz current.
 If the frequency is raised to in the thousands of hertz it will be known as the high frequency current.
 Human body cannot respond to the higher frequencies i.e. muscles are not contracted on the high frequency current,
accordingly so there is no ventricular fibrillation.
 However the Heat energy can be lethal for the patient, biomedical engineer uses this property in the surgical diathermy in
which high frequency current is using to cut and coagulate during surgery.

3.3 Describe effects of high frequency current of surgical Diathermy


There are two types of diathermy machines, One is the surgical diathermy and other one is the physiotherapy diathermy machine.
In diathermy machine, generator is used to generate the high frequency current i.e. RF
During the surgical diathermy the patient forms part of an electrical circuit. Current passes from a suitable generator via an active
electrode through the living tissue and back to the generator via a disperse electrode.

Diathermy machine convert ordinary 240 volts AC into high frequency current(R.F).the operating frequency is usually within the
range of 300KHz to 3000kHz.The high Frequency current produces sufficient heating to cut through the tissue or to achieve
hemostasis, depending on the surgeon requirements without causing muscle contractions.

3.4 State precaution against high frequency current

Precaution against the high frequency current of diathermy


Do not locate patient plate over bony or hairy areas scar tissue or implanted prostheses.
Do not cut or fold patient plate or make it smaller for any reason. Remember minimum safety size is 10 sq inches.
Do not use such patient plates in which you have a doubt in regard the conduction of the current.
Do not place the active electrode on grounded surface when not in use
Do not activate the active until it is close to the surgical site
Do not wrap patient plate or active electrode cables around the metal objects.
Do not spark the active electrode to ground to check power unit.

04 The direct current effects on the human body


Direct current (DC) is the unidirectional flow of electric charge. Direct current is produced by sources such as batteries, p ower
supplies, thermocouples, solar cells, or dynamos. Direct current may flow in a conductor such as a wire, but can also flow through
semiconductors, insulators, or even through a vacuum as in electron or ion beams. The electric current flows in a constant direction,
distinguishing it from alternating current (AC). A term formerly used for this type of current was galvanic current

The effects of AC (alternating current) depends largely on frequency, low frequency tends to be much more dangerous than high
frequency. AC with the same amperage and voltage as DC is more dangerous and provoke worse effects on the human body. Low
frequency AC provokes muscle contraction (tetany) which can induce the "cannot let go" effect by freezing the muscles of the hand.
This happens because the flexors of the hand are stronger than the extensors, so when an external electric estimation is applied the
muscles flexors of the hand win. AC has more tendency to induce heart fibrillation while DC makes the heart stand still. That is why
defibrillation equipment is DC, which stops the heart and gives a chance to recover.

4.2 Define the physiological effects of direct current.

The effects of AC (alternating current) depends largely on frequency, low frequency tends to be much more dangerous than high
frequency. AC with the same amperage and voltage as DC is more dangerous and provoke worse effects on the human body. Low
frequency AC provokes muscle contraction (tetany) which can induce the "cannot let go" effect by freezing the muscles of the hand.
This happens because the flexors of the hand are stronger than the extensors, so when an external electrical stimu lation is applied,
the flexors outdo the extensors. AC has a more of a tendency to induce heart fibrillation while DC makes the heart stop. That is why
defibrillation equipment is DC, which stops the heart and gives a chance to recover.

4.3 State precaution against direct current effects


Main source of DC currents are the batteries, capacitors and power supplies.
Always use ground cable intact/active while working with DC current.

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Technician should insulated while working with the DC current.
Do not think that Dc current is not lethal, DC current is much more lethal than AC current.

05 The leakage current

5.1 Describe the hazards of leakage current


Causes of leakage currents
If any conductor is raised to a potential above that of earth, some current is bound to flow from that conductor to earth. This is true
even of conductors that are well insulated from earth, since there is no such thing as perfect insulation or infinite impedance. The
amount of current that flows depends on:
a. the voltage on the conductor.
b. the capacitive reactance between the conductor and earth.
c. the resistance between the conductor and earth.
The currents that flow from or between conductors that are insulated from earth and from each other are called leakage currents,
and are normally small. However, since the amount of current required to produce adverse physiological effects is also small, such
currents must be limited by the design of equipment to safe values.
For medical electrical equipment, several different leakage currents are defined according to the paths that the currents take.

5.2 Enlist various types of leakage current

5.3 Describe the enclosure leakage current.


Enclosure leakage current is defined as the current that flows from an exposed conductive part of the enclosure to earth through a
conductor other than the protective earth conductor.

If a protective earth conductor is connected to the enclosure, there is little point in attempting to measure the enclosure l eakage
current from another protectively earthed point on the enclosure, since any measuring device used is effectively shorted out by the
low resistance of the protective earth. Equally, there is little point in measuring the enclosure leakage current from a prot ectively
earthed point on the enclosure with the protective earth open circuit, since this would give the same reading as measurement of
earth leakage current as described above. For these reasons, it is usual when testing medical electrical equipment to measure
enclosure leakage current from points on the enclosure that are not intended to be protectively earthed (see figure 3). On many
pieces of equipment, no such points exist. This is not a problem. The test is included in test regimes to cover the eventuality where
such points do exist and to ensure that no hazardous leakage currents will flow from them.

Figure 3. Enclosure leakage current path

5.4 Describe the hazards of earth leakage current.


Earth leakage current
Earth leakage current is the current that normally flows in the earth conductor of a protectively earthed piece of equipment. In
medical electrical equipment, very often, the mains is connected to a transformer having an earthed screen. Most of the earth
leakage current finds its way to earth via the impedance of the insulation between the transformer primary and the inter-winding
screen, since this is the point at which the insulation impedance is at its lowest (see figure 2).

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Earth leakage current path,Figure 2. Earth leakage current path
Under normal conditions, a person who is in contact with the earthed metal enclosure of the equipment and with another earthed
object would suffer no adverse effects even if a fairly large earth leakage current were to flow. This is because the impedance to
earth from the enclosure is much lower through the protective earth conductor than it is through the person. However, if the
protective earth conductor becomes open circuited, then the situation changes. Now, if the impedance between the transformer
primary and the enclosure is of the same order of magnitude as the impedance between the enclosure and earth through the
person, a shock hazard exists.
It is a fundamental safety requirement that in the event of a single fault occurring, such as the earth becoming open circuit, no
hazard should exist. It is clear that in order for this to be the case in the above example, the impedance between the mains part (the
transformer primary and so on) and the enclosure needs to be high. This would be evidenced when the equipment is in the normal
condition by a low earth leakage current. In other words, if the earth leakage current is low then the risk of electric shock in the event
of a fault is minimised.

5.5 Describe the hazards of patient leakage current.


Patient leakage current is the leakage current that flows through a patient connected to an applied part or parts. It can either flow
from the applied parts via the patient to earth or from an external source of high potential via the patient and the applied parts to
earth. Figures 4a and 4b illustrate the two scenarios.

Figure 4a. Patient leakage current path from equipment

Figure 4b. Patient leakage current path to equipment

5.6 Describe the hazards of patient auxiliary leakage current.


The patient auxiliary current is defined as the current that normally flows between parts of the applied part through the patient, which
is not intended to produce a physiological effect (see figure 5).

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5.7 State the admissible leakage current in domestic and commercial premises
What is a safe level of leakage current?
Depending on the type of equipment, acceptable levels of leakage current have been determined
and are generally outlined in the appropriate international or regional standard. Acceptable
levels of leakage current are dependant on the classification of the particular type of equipment.
The basic principle behind protection against electrical shock is to have at least two levels of protection.

CLASS I
Class I products use Basic Insulation in combination with Protective Earth. These products will
have a three-prong power cord and the ground blade will be attached to any accessible metal on
the product.

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PRODUCT II
Products that have a two-prong power cord are Class II products. Class II products rely not only
on basic insulation but also supplemental insulation or reinforced insulation. These products are
often referred to as double insulated products as protection against shock relies on two layers of
insulation.

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5.8 State the limitation of leakage current in hospitals.

Question: Responsibilities of biomedical Engineer


The responsibility of Biomedical Engineer is very vast, as the biomedical engineer is dealing in the healthcare sector, so th e chance
of human error should be minimize, otherwise mistaken will be the threaten to life of Patients and healthcare workers.
In regard of patient safety Bio-medical engineer has a very important role in order to provide safe n secure, operation of, and
medical equipment from the electric shock. However mechanical hazard is also very dangerous, by providing an appropriate training
to the end user, biomedical engineer can also secure the life of patient from various accidents by the misuse of medical equipment.

Following steps should be taken by the biomedical engineer to avoid an incident of electrocution.

1-Always use the grounded power cable with the medical equipment. e.g. use three pin plugs.
2- Always install the grounding electrical connection in the electric sockets.
3-Equipment should be earth, by connecting an earthen cable with the medical equipment.
4-By educating the Medical Staff in regard of electricity, importance of grounding and prevention from electric shock.
5-always check the cracks and damages in the electric cables.
6- Proper training and use of medical equipment can also prevent the incidents of electrocution.
7- Maintenance i.e. IPM inspection and preventive maintenance should be perform as per schedule.
8-Equipment should be cleaned from the germs while deliver to the wards after the repair.
9- Fuses should be checked and appropriate rating fuses should be install in medical equipment.

ULTRASOUND AND RADIATION PHYSICS

INTENSITY OF ULTRASOUND BEAM

Meaning of ultrasound in term of power and intensity


Approximate values for intensity and power levels of diagnostic ultrasound beam

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The decibel notation and why it is employed
The change of intensity with depth in an attenuating medium uniform and non uniform
Effect on intensity of the following wave phenomena
Interference, Standing waves, Resonance.

THE PROPOGATION OF ULTRASOUND IN TISSUE


Definition of acoustic impedance

Patient Safety

Course outline
1-Basic Physics of Ultrasound
2-Meaning of simple harmonic motion
3-how sound wave are produced
4-difference between longitdnal wave and tranverse wave .
5-Transverse Wave:propogation of longitudinal sound wave through a medium
6-definition and unit of frequency,wave length, and velocity of sound wave and relation between them.
7-definition of particle displacement,amplituide,particle velocity,amplituide,particle pressure amplituide .
8-definition and unit of phase and Phase Difference.
9-contineous and pulsed wave ultrasound
10-frequencies of the ultrasound in diagnostic purposes.
11-depending of the wave elasticity on the wearticity and density of the medium
12-veloicty of Ultrasound in common material,Air,Bone,Muscle, Soft tissue(average)water,steel,Persia .

INTENSITY OF TAN ULTRASOUND BEAM


1-meaning of ultrasound beam in term of power and intensity
2-apprximate value for intensity and powerlevels of a diagnostic Ultrasound Beam
3-decible notation and why it is employed.
4-the change of intensity with depth in an attenuating medium,uniform and non-uniform
5-effect of intensity of the following wave phenomena,Inteference nstanding waves,resonance.

THE PROPOGATION OF ULTRASOUND IN TISSUE.


1-definition of acoustic medium
2- reflection at a flat interface between two media of different acoustic impedance
3-dependence of reflection on acoustic impedance,angle of incidience angle of incidience
4-scattering of ultrasound beam at a number of scattering centres, a rough surface.
5-refraction at interface in tissue
6-mechanism of absorption in tissue
7-attenuation in tissue,the factors which contribute,specially the dependence on the frequency.

X-RAYS AND RADIATION PHYSICS


1-structure of the atom in terms pf proton,electron and neutron,
2-meaining of the term isotopes,nuclide atomic numberand mass number
3-shells,electron binding energies,energy levels

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PRACTICALS

Experiment: Protective Earth Continuity Test


Objective: to understand the continuity Test
Introduction:
Equipment used: Multimeter and any medical equipment for example Patient Monitor.
Procedure: 1. Protective earth continuity test (Class I)

With this test the resistance of the PE conductor is measured between the PE connection of the mains plug and the unpainted m etal
housing of the equipment. This is the most important test and we should always start safety tests with this one. If an equipment fails
this test it will also fail the other tests.
According to many guidelines this test should be done with a safety analyser or PAT tester. The analyser applies a 50 Hz AC-
current to the PE connection. For testing electrical equipment (e.g. motors) a test current of 10 A or even 20 A for at least 5 seconds
is demanded. Since this current can be much too high for many electronic and medical equipment other standards suggest a test
current of 1 A or even only 200 mA.
For this reason there is nothing wrong testing the protective earth continuity of medical equipment with an ohmmeter. The
measurement conditions are not perfect but on the other hand the ohmmeter does not do any damage to the medical equipment.

Equipment is disconnected from mains.


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

Work Sheet:
Sr No Equipment Used Results in Ohms

PRACTICAL No.2

Experiment: Insulation resistance Test


Objective: to understand the insulation resistance Test
Introduction:
Equipment used: Multimeter or any medical equipment.
Procedure: 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. 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.
Standard test voltage for electrical equipment is 500 V. Electronic and medical equipment which often contain voltage limitin g
devices such as MOV or EMI suppression 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

For low-income countries: Instead the insulation test a patient leakage current test can be done (3c).

Radiation Protection:
Genetic and somatic effect of ionization radiation and how to access their risk.

Genetic
Relating to genes or heredity.

Somatic:
Relating to the body, especially as distinct from the mind.

Ionization Radiation:
Ionizing radiation is radiation that carries sufficient energy to detach electrons from atoms or molecules, thereby ionizing them.
Ionizing radiation is made up of energetic subatomic particles, ions or atoms moving at high speeds, and electromagnetic waves on
the high-energy end of the electromagnetic spectrum.

What is the difference between Genetic and Somatic effects of radiation?


Genetic effects are those that occur in the descendants of a parent whose DNA molecules are modified due to exposure to
ionizing radiation. Somatic effects are those which occur in the exposed individual. Genetic effects may affect subsequent
unexposed generations; somatic effects are limited to the exposed individual.

What is Radiation?
In physics, radiation is the emission or transmission of energy in the form of waves or particles through space or through a material
medium.

This includes:
Electromagnetic radiation, such as radio waves, microwaves, infrared, visible light, ultraviolet, x-rays, and gamma radiation (γ)
Particle radiation, such as alpha radiation (α), beta radiation (β), and neutron radiation (particles of non-zero rest energy)
Acoustic radiation, such as ultrasound, sound, and seismic waves (dependent on a physical transmission medium)
Gravitational radiation, radiation that takes the form of gravitational waves, or ripples in the curvature of space-time.

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Illustration of the relative abilities of three different types of ionizing radiation to penetrate solid matter. Typical alpha
particles (α) are stopped by a sheet of paper, while beta particles (β) are stopped by an aluminum plate. Gamma radiation
(γ) is damped when it penetrates lead. Note caveats in the text about this simplified diagram

Radiation is often categorized as either ionizing or non-ionizing depending on the energy of the radiated articles. Ionizing radiation
carries more than 10 eV, which is enough to ionize atoms and molecules, and break chemical bonds. This is an important distinction
due to the large difference in harmfulness to living organisms. A common source of ionizing radiation is radioactive materials that
emit α, β, or γ radiation, consisting of helium nuclei, electrons or positrons, and photons, respectively. Other sources include X-rays
from medical radiography examinations and muons, mesons, positrons, neutrons and other particles that constitute the secondar y
cosmic rays that are produced after primary cosmic rays interact with Earth's atmosphere.
Gamma rays, X-rays and the higher energy range of ultraviolet light constitute the ionizing part of the electromagnetic spectrum. The
word "ionize" refers to the breaking of one or more electrons away from an atom, an action that requires the relatively high energies
that these electromagnetic waves supply. Further down the spectrum, the non-ionizing lower energies of the lower ultraviolet
spectrum cannot ionize atoms, but can disrupt the inter-atomic bonds which form molecules, thereby breaking down molecules
rather than atoms; a good example of this is sunburn caused by long-wavelength solar ultraviolet. The waves of longer wavelength
than UV in visible light, infrared and microwave frequencies cannot break bonds but can cause vibrations in the bonds which are
sensed as heat. Radio wavelengths and below generally are not regarded as harmful to biological systems. These are not sharp
delineations of the energies; there is some overlap in the effects of specific frequencies.

Ionizing radiation

Radiation with sufficiently high energy can ionize atoms; that is to say it can knock electrons off atoms, creating ions. Ionization occurs

when an electron is stripped (or "knocked out") from an electron shell of the atom, which leaves the atom with a net positive charge.

Because living cells and, more importantly, the DNA in those cells can be damaged by this ionization, exposure to ionizing radiation

is considered to increase the risk of cancer. Thus "ionizing radiation" is somewhat artificially separated from particle radiation and

electromagnetic radiation, simply due to its great potential for biological damage. While an individual cell is made of trillions of atoms,

only a small fraction of those will be ionized at low to moderate radiation powers. The probability of ionizing radiation causing cancer

is dependent upon the absorbed dose of the radiation, and is a function of the damaging tendency of the type of radiation (equivalent

dose) and the sensitivity of the irradiated organism or tissue (effective dose).

If the source of the ionizing radiation is a radioactive material or a nuclear process such as fission or fusion, there is particle radiation

to consider. Particle radiation is subatomic particle accelerated to relativistic speeds by nuclear reactions. Because of their momenta

they are quite capable of knocking out electrons and ionizing materials, but since most have an electrical charge, they don't have the

penetrating power of ionizing radiation. The exception is neutron particles; see below. There are several different kinds of these

particles, but the majority are alpha particles, beta particles, neutrons, and protons. Roughly speaking, photons and particles with

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energies above about 10 electron volts (eV) are ionizing (some authorities use 33 eV, the ionization energy for water). Particle radiation

from radioactive material or cosmic rays almost invariably carries enough energy to be ionizing.

Most ionizing radiation originates from radioactive materials and space (cosmic rays), and as such is naturally present in the

environment, since most rocks and soil have small concentrations of radioactive materials. Since this radiation is invisible and not

directly detectable by human senses, instruments such as Geiger counters are usually required to detect its presence. In some cases,

it may lead to secondary emission of visible light upon its interaction with matter, as in the case of Cherenkov radiation and radio-

luminescence.

Graphic showing relationships between radioactivity and detected ionizing radiation

Ionizing radiation has many practical uses in medicine, research and construction, but presents a health hazard if used improperly.

Exposure to radiation causes damage to living tissue; high doses result in Acute radiation syndrome (ARS), with skin burns, hair loss,

internal organ failure and death, while any dose may result in an increased chance of cancer and genetic damage; a particular form

of cancer, thyroid cancer, often occurs when nuclear weapons and reactors are the radiation source because of the biological

proclivities of the radioactive iodine fission product, iodine-131.[4] However, calculating the exact risk and chance of cancer forming in

cells caused by ionizing radiation is still not well understood and currently estimates are loosely determined by population based data

from the atomic bombings of Hiroshima and Nagasaki and from follow-up of reactor accidents, such as the Chernobyl disaster. The

International Commission on Radiological Protection states that "The Commission is aware of uncertainties and lack of precision of

the models and parameter values", "Collective effective dose is not intended as a tool for epidemiological risk assessment, a nd it is

inappropriate to use it in risk projections" and "in particular, the calculation of the number of cancer deaths based on collective effective

doses from trivial individual doses should be avoided

Ionization radiation regulations, approved codes of practice and guidance notes,


Including basic philosophy dose limit
Did not get the notes online.
Designation of workers and the work place the purpose of the local rules.

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