UNIT V: PROSTHESES
AND AIDS
ELECTRICAL SAFETY
For
MEDICAL
EQUIPMENT
Electrical Safety – Medical Equipment
Contents:
1 Various Test Equipment used in
Biomedical
Engineering
2 Introduction to Electrical Safety
3 Electricity - Physiological Effects
4 General Electrical Safety
5 Electricity – Leakage Current
6 Electrical Equipment – Classes and
Types
7 Electrical Safety Tests
INTRODUCTION TO VARIOUS TEST
EQUIPMENT USED IN BIOMEDICAL
ENGINEERING
Workshop Tool & Equipment
Toolkit for general repair
Workshop Tool & Equipment
Insulation and Resistance Measuring Instrument, 1000 V, Digital
Workshop Tool & Equipment
Soldering Station
with temperature controller
Workshop Tool & Equipment
Analog Multimeter
Digital Multimeter
Test Instrument
Electrical Safety
Analyser
Test Instrument
Electrical Safety
Analyser
Test Instrument
Test Instrument
It measures delivered energy on its internal load. The
defibrillator pulse is stored and it can be viewed via
ECG output leads, paddles or scope output.
Test Instrument
Blood pressure simulator
that provides simulation
to test blood pressure
monitors.
Test Instrument
The pulse oximeter testing method to simulate the
light absorption and arterial blood flow
of a human finger
Test Instrument
Power meter to service
the 1 MHz and 3 MHz therapy level
ultrasound generators.
Test Instrument
External pacemaker tester designed for
accurately testing all types of
external pacemaker.
Test Instrument
SAFETY TESTERS
Safety Check
– Electrical Safety Tests (IEC 601)
– The basic purpose of safety testing in medical electrical
equipment is to be sure that a device is safe for the patient
and user. Such as:
• Grounding resistance of portable medical equipment
measured between equipment chassis and ground pin of
power plug shall not exceed 0.50 ohms.
Biomedical Engineer-definition
• Biomedical Engineers assist in struggle
against illness and disease by providing
support for materials and tools that can be
utilized for diagnosis and treatment by health
care professionals.
• Biomedical Engineer have achieved this
position by assuming responsibility for
managing the safe use of medical equipment
within the hospital environment
Electrical Shock
• Electric Shock : unwanted or
unnecessary physiological response to
current.
• Three phenomena :
– (1) electrical stimulation of excitable tissue
(nerve & muscle)
– (2) resistive heating of tissue, and
– (3) electrochemical burns and tissue damage
Electrical Safety
Micro-shock" is an otherwise imperceptible
electric current applied directly, or in very close
proximity, to the heart muscle of sufficient
strength, frequency, and duration to cause
disruption of normal cardiac function.
Macroshock is a medical term for the
effects of body exposed to electrical current,
which can lead to severe injury or death.
Electrical Safety
LEAKAGE CURRENTS:
Leakage current is the current that flows from either AC or DC
circuit in equipment to the chassis, or to the ground, and can
be either from the input or the output.
If the equipment is not properly grounded, the current flow
through other paths such as the human body.
This may also happen if the ground is inefficient or is
interrupted intentionally or unintentionally.
Electrical Safety
• Electric Safety is the best possible limitation
of hazardous electrical Macro – and/or
Microshocks, sustained by patients, as well
as explosion, fire or damage to equipments
and buildings.
Single Phase Power Supply
• The application of the safety testing on this training will
only apply to the Single Phase ( 3 wires ) 100 to 240
Volt power supply.
• Any medical equipment use either 3 or 2 pins plug which
connected to the wall socket shall follow this electrical
safety procedure.
The IEC 601.1 Standard
Several standard serve as ruling authority
in determine how medical equipment are
to be tested such UL, CSA, CE, TUV …
The International Electro Technical
Commission’s IEC 601-1 standard is accepted
and implemented around the world.
All this explanation will be based on IEC 601-
1 Standard
The IEC 601.1 Standard
Medical Electrical Equipment
Medical Electrical Equipment provided with no more than
one connection to a particular supply mains and intended
to;
1. Diagnose the patient,
2. Treat the patient,
3. Monitor the patient
4. under medical
supervision,
5.
Makes physical or
electrical contact with
the patient ,
Transfers energy to or from the patient and/or detects such
energy transfer to or from patient.
The equipment includes those accessories as defined by
Safety of Medical Equipment
The purpose of safety testing medical electronic equipment
is to ensure that a device is safe from electrical hazards to
patients, maintenance personnel's and users.
Electric shock are caused by electricity flowing through the
body after touching a damaged electrical device and results
muscle spasms, burns, cardiac and respiratory arrest and
Ventricular Fibrillation
Electrical Safety
• Electric safety in hospital is a shared
responsibility between several parties, in
addition to the physician, including:
• The nurses
• All engineers (electrical, biomedical, facility,
etc)
• Manufacturers
• The hospital
Electrical Safety – Critical Points
• The electrical installation, no matter how safe, is only
part of the safety requirements.
• Plugs and cords must be checked and rejected if
defective.
• Only devices tested for safety should be used.
• Electrical compatibility of the entire electrical system
must be tested regularly.
• Patients leads must be attached and connected
properly.
• Radio-frequency devices (including mobile
telephones) must be excluded.
Basic Safety
Basic safety should be performed on line powered
before installation and after every repairs are;
– Ground wire integrity ( Resistance )
– Ground wire leakage
The basic electrical characteristic usually cause the
most leakage currents in modern equipment is
Capacitive Reactance Coupling in power cord.
The typical range of human body resistance with the
skin intact is 500 Ohm to 1,000 Ohm.
The “let go” current of a shock is 14 mA in most
people.
Why Electrical Safety?
Electrical safety NOT dependent on voltage but on
Leakage Current.
At low voltage, leakage current flow through body
may be fatal to us.
Patient may connected to several device
simultaneously . (ICU.)
Patient may connected conductively with electronic
circuit. (ECG.)
Contact directly to internal tissue. ( natural orifices
or break in the skin.)
Electricity - Physiological Effects
Burns
When an electric current passes through
any substance having electrical
resistance, heat is produced. The amount
of heat depends on the power-dissipated
(I2R or VI). Whether or not the heat
produces a burn depends on the current
density.
Burns
Electricity - Physiological Effects
Muscle Cramps
When an electrical stimulus is applied to a motor
nerve or muscle, the muscle does exactly what it is
designed to do in the presence of such a stimulus i.e.
it contracts. The prolonged involuntary contraction
of muscles (tetanus) caused by external electrical
stimulus is responsible for the phenomenon where a
person who is holding an electrically live object can
be unable to let go.
A muscle cramp is a painful, involuntary
muscle contraction.
Electricity - Physiological Effects
Respiratory Arrest
The muscles between the ribs (intercostal muscles)
need to repeatedly contract and relax in order in
order to facilitate breathing.
Prolonged tetanus of these muscles can
therefore prevent breathing.
Electricity - Physiological Effects
Cardiac Arrest
The heart is a muscular organ which needs to able
to contract and relax repetitively in order to perform
its function as a pump for the blood.
Tetanus of the heart musculature will prevent the
pumping process.
Cardiac Arrest
Electricity - Physiological Effects
Ventricular Fibrillation
The ventricles of the heart are the chambers
responsible for pumping blood out of the heart. When
the heart is in ventricular fibrillation, the musculature
of the ventricles undergoes irregular, uncoordinated
twitching resulting in no net blood flow. The
condition proves fatal if not corrected in a very short
space of time.
Ventricular fibrillation (VF) is a deadly arrhythmia.
In VF, the electrical signals that trigger the
heartbeat become very fast and chaotic in the
lower chambers of the heart. The heart no longer
can pump blood to the brain or body.
Electricity - Physiological Effects
Electricity - Physiological Effects
Electricity - Physiological Effects
Electrolysis
The movement of ions of opposite polarities in
opposite directions through a medium is called
electrolysis and can be made to occur be made to
occur by passing DC currents through body tissues or
fluids.
Electricity Conduction Mechanism
Charge carrier Charge carrier
e- Charge carrier skin e-
ions
cell
wire(metal) wire(metal)
electrode(metal)
Tissue electrode(metal)
Electrolyte/Dielectric
Electrochemical Reactions
Important Susceptibility Parameters
For dog: 20A, human : 80~600 A
Safety limit : 10 A
Effect of entry point on current
distribution
Macroshock
Hazards
Macroshock is the most
common type of shock
received and occurs when
the human body becomes a
conductor of electric current
passing by means other than
directly through the heart.
Microshock
Hazards
Electrically conducting devices
unintentionally make direct
contact with heart muscles,
ventricular fibrillation may be
induced by minute current (e.g.
200 uA) well below the threshold
of feeling.
Electricity - Leakage Currents
Leakage Currents
Current that is not functional. The following
leakage currents are defined: Earth Leakage
Current , Enclosure Leakage Current , and
Patient Leakage Current .
Earth Enclosure Patient
Leakage Leakage Leakage
Current Current Current
Electricity - Leakage Currents
Causes of leakage currents
If any conductor is raised to a potential above earth
potential, then 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 resistance. The amount of
current that flows depends on:
• The voltage on the conductor
• The capacitive reactance between the conductor and
earth
• The resistance between the conductor and earth
Leakage
Current
Leakage current flows between
power supply wires and earth
ground within the rated value. In
case of the multiple operation,
however, the total leakage current
will be the sum of the leakage
current flows from each power
supply.
Electricity - Leakage Currents
Earth leakage current
Earth leakage current is the current which
normally flows in the earth conductor of
a protectively earthed piece of
equipment.
Electricity - Leakage Currents
Electricity –
Enclosure Leakage Currents
Enclosure leakage current
Enclosure leakage current is described as
the current that flows from an exposed
conductive part of the conductor to earth
through a conductor other than the
protective earth conductor.
Electricity –
Enclosure Leakage Currents
Electricity –
Patient Leakage Current
Patient leakage current
Patient leakage current is the leakage current that
flows through a patient connected to an applied part
or parts.
Electricity –
Patient Leakage Current
Electricity –
Patient Auxiliary Current
Patient auxiliary current
The patient auxiliary current is defined as the current
which normally flows between parts of the applied
part through the patient which is not intended to
produce a physiological effect.
Electricity –
Patient Auxiliary Current
Electricity –
Class and Types of Equipment
Classes of Equipment
All electrical equipment is categorized into
classes according to the method of
protection against electric shock that is
used.
Types of Equipment
The degree of protection for medical electrical
equipment is defined by the type
designation.
Electricity –
Class of Equipment
Classes of Equipment
All electrical equipment is categorized into
classes according to the method of protection
against electric shock that is used.
CLASS I CLASS II
CLASS III
Electricity –
Class of Equipment
Class I equipment
Class 1 equipment has a protective earth. The basic
means of protection is the insulation between live
parts and exposed conductive parts such as the
metal enclosure. In the event of a fault which
would otherwise cause an exposed conductive part
to become live, the supplementary protection (i.e.
protective earth) comes into effect.
General Electrical Safety
CLASS I EQUIPMENT
Electricity –
Class of Equipment
Class II equipment
The method of protection against electric shock in
the case of class II equipment is either double
insulation or reinforced insulation. In double
insulated equipment the basic protection is afforded
by the first layer of insulation. If basic protection
fails then supplementary protection is afforded by a
second layer of insulation preventing contact with
live parts.
Electricity –
Class of Equipment
Class II equipment
The symbol for class II equipment is 2
concentric squares indicating double
insulation as shown below.
General Electrical Safety
CLASS II EQUIPMENT
Electricity –
Class of Equipment
Class III equipment
Class III equipment is defined as that in which
protection against electric shock relies on the fact
that no voltages higher than safety extra low
voltage (SELV) are present.SELV is defined in turn
in the relevant standard as a voltage not exceeding
25V ac or 60V dc.
Electricity –
Types of Equipment
Types of Equipment
The degree of protection for medical
electrical equipment is defined by the type
designation.
Type B Type BF Type CF
Electricity –
Types of Equipment
Type Symbol Definition
B Equipment providing a particular degree of protection
against electric shock,
particularly regarding allowable leakage currents and
reliability of the
protective earth connection (if present).
BF As type B but with isolated or floating (F type) applied part
or parts
CF Equipment providing a higher degree of protection against
electric shock
than type BF, particularly with regard to allowable leakage
currents,
and having floating applied parts.
Electrical Safety Tests
Normal Condition
A basic principle behind the philosophy of
electrical safety is that in the event of a
single abnormal external condition arising
or of the failure of a single means of
protection against a hazard, no safety
hazard should arise.
Electrical Safety Tests
Single Fault Condition
Condition in which a single means of
electrical safety protection is defective or
an abnormal condition is present.
Examples of a single fault condition would
be interruption of the ground conductor on
a Class I equipment or opening of the
neutral supply conductor to the
equipment.
Electrical Safety Tests
Single Fault Condition
Protective Earth Continuity
Applicable to Class1, all types
Limit 0.2 ohms
Insulation Tests
Applicable to Class 1, all types
Limit Not less than 50Mohms
Insulation Tests
Applicable to Class II, all types
having applied parts
Limit : > 50 MOhms
Earth Leakage Current
Applicable to: Class 1 equipment all types
Limits: 0.5mA in NC, 1mA in SFC or 5mA and 10mA
respectively for permanently installed equipment
Enclosure Leakage Current
Applicable to Class 1 and class II
equipment , all types.
Limit0.1mA in NC, 0.5mA in SFC
Patient Leakage Current
Applicable to All Classes B and BF
equipment having applied parts
Limits 0.1mA in NC, 0.5mA in SFC
Patient Auxiliary Current
Applicable to All equipment having
applied parts.
Limits 0.1mA in NC, 0.5mA in SFC
Mains on Applied Parts
Applicable to Class 1 and class II
equipment , types BF&CF equipment having
applied parts.
Limits BF 5mA; CF 0.05mA per electrode
Safety Test as done by
BEMS
Electrical Safety Review
Electrical Safety and the Patients Depends on
Three Things: -
• An alert, caring, knowledgeable person
• Properly maintained, and applied equipment
• Proper grounding or double insulation of line-
powered equipment
Electrical Safety Review
Report, tag, and do not use equipment with:
• Frayed wires or cracked insulation
• Damaged plugs or missing ground prongs
Electrical Safety Review
Report, tag, and do not use receptacles with:
• Only two slots
• Missing cover plates
• Loose mountings
• Weak gripping force
Electrical Safety
Review
Inspections of Equipment: -
• Check of Strain-Relief
Electrical Safety Review
Avoid:
• Using cheaters (three-prong adapters)
• Using extension cords
• Placing liquids on electrical equipment
• Pulling plugs out of receptacles by the cord
• Rolling equipment over power cords
• Using defective equipment or receptacles
• Using equipment that sparks, smokes, or shocks
Electrical Safety Review
Be sure that users know how to use equipment
properly. Also be sure to:
• Check that line-powered equipment has three-
wire grounding cords, unless device is double
insulated
• Ask for help and instruction when needed
• Report defective equipment and receptacles
