Medical Electrical Safety Presentation Transcript

1. ELECTRICAL SAFETY
2. 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
3. INTRODUCTION TO VARIOUS TESTEQUIPMENT USED IN BIOMEDICAL
ENGINEERING
4. Workshop Tool & Equipment Toolkit for general repair
5. Workshop Tool & Equipment Insulation and Resistance Measuring
Instrument, 1000 V, Digital
6. Workshop Tool & Equipment Soldering Station with temperature controller
7. Workshop Tool & Equipment Analog Multi meter Digital Multi meter
8. Test Instrument Electrical Safety Analyzer
9. Test Instrument Electrical Safety Analyzer
10. Test Instrument
11. 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.
12. Test Instrument Blood pressure simulator that provides simulation to test
blood pressure monitors.
13. Test Instrument The pulse oximeter testing method to simulate the light
absorption and arterial blood flow of a human finger
14. Test Instrument Power meter to service the 1 MHz and 3 MHz therapy level
ultrasound generators.
15. Test Instrument External pacemaker tester designed for accurately testing
all types of external pacemaker.

16. Test Instrument

17. Test Instrument ESU Analyzer Measure output power and RF leakage
18. Test Instrument Infusion Pump Analyzer
19. SAFETY TESTER 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.
20. ELECTRICALSAFETY
21. 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
22. A Historical Perspective Engineers first enter to clinical scene : late 1960s
in response to concerns about electrical safety of hospital patient Ralph Nader
(consumer activist) : at the very least, 1200 Americans are electrocuted annually
during routine diagnostic and therapeutic procedures in hospitals Ladies Home
Journal, April 24, 1970 Raise the level of concern about safe use of medical
device
23. A Historical Perspective Overnight growth of a new industry : hospital
electrical safety Joint Commission on the Accreditation of Hospital : hospital
must inspect all equipment used on or near a patient for electrical safety at least
every 6 months Hospital administrators options Paying medical device
manufacturer Service contracting In-house staff
24. Safety Issue In USA, about 10,000 device-related patient injuries each
year Most injuries are attributable to improper use of a device as a result of
inadequate training and lack of experience Medical personnel rarely read user
manuals until a problem occurred Everything that can go wrong eventually will
go wrong Murphys law

25. 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
26. Electrical Safety Electric Safety is the best possible limitation of hazardous
electrical Macro and/or Microshock, sustained by patients, as well as explosion,
fire or damage to equipment and buildings.
27. 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.

International Electro Technical Commissions IEC 601-1 standard is accepted and

-1
Standard
29. The IEC 601.1 Standard
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 under medical
supervision,4. Makes physical or electrical contact with the patient ,5. 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 the
manufacturer which are necessary to enable the normal use of the equipment.
electronic equipment is to ensure that a device is safe from electrical hazards to
electricity flowing through the body after touching a damaged electrical device
and results muscle spasms, burns, cardiac and respiratory arrest and Ventricular
Fibrillation

32. 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
33. 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 should be performed on line powered before
installation and after every repairs are; Ground wire integrity ( Resistance )
leakage currents in modern equipment is Capacitive Reactance Coupling in power

ent on voltage but on

ctly to
internal tissue. ( natural orifices or break in the skin.)
36. Electricity - Physiological EffectsBurnsWhen an electric current passes
throughany substance having electricalresistance, heat is produced. The
amountof heat depends on the power-dissipated(I2R or VI). Whether or not the
heatproduces a burn depends on the currentdensity.
37. Burns
38. Electricity - Physiological EffectsMuscle 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.
39. A muscle cramp is a painful, involuntarymuscle contraction.

40. Electricity - Physiological EffectsRespiratory 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.
41. Respiratory Arrest
42. Electricity - Physiological EffectsCardiac 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.
43. Cardiac Arrest
44. Electricity - Physiological EffectsVentricular 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.
45. Ventricular fibrillation (VF) is a deadly arrhythmia.In VF, the electrical signals
that trigger theheartbeat become very fast and chaotic in thelower chambers of
the heart. The heart no longercan pump blood to the brain or body.
46. Electricity - Physiological Effects
47. Electricity - Physiological Effects
48. Electricity - Physiological EffectsElectrolysis 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.
49. Electricity Conduction MechanismCharge carrier Charge carrier e- skin eCharge carrier ions cellwire(metal) wire(metal) electrode(metal) Tissue
electrode(metal) Electrolyte/Dielectric Electrochemical Reactions

51. Macroshock HazardsMacroshock is the mostcommon type of shockreceived

and occurs when thehuman body becomes aconductor of electric currentpassing
by means other thandirectly through the heart.
52. Microshock HazardsElectrically conducting devicesunintentionally make
directcontact with heart muscles,ventricular fibrillation may beinduced by minute
current (e.g.200 uA) well below the thresholdof feeling.
53. General Electrical Safety
54. General Electrical Safety
55. General Electrical Safety
56. General Electrical Safety
57. General Electrical Safety
58. General Electrical Safety
59. General Electrical Safety
60. General Electrical Safety
61. Electricity - Leakage CurrentsLeakage 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
62. Electricity - Leakage CurrentsCauses 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
63. Leakage CurrentLeakage current flows betweenpower supply wires and
earthground within the rated value. Incase of the multiple operation,however,
the total leakage currentwill be the sum of the leakagecurrent flows from each
powersupply.

64. Electricity - Leakage CurrentsEarth leakage current Earth leakage current is

the current which normally flows in the earth conductor of a protectively earthed
piece of equipment.
65. Electricity - Leakage Currents
66. Electricity Enclosure Leakage CurrentsEnclosure 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.
67. Electricity Enclosure Leakage Currents
68. Electricity Patient Leakage CurrentPatient leakage currentPatient leakage
current is the leakage current that flows through a patient connected to an
applied part or parts.
69. Electricity Patient Leakage Current
70. Electricity Patient Auxiliary CurrentPatient auxiliary currentThe 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.
71. Electricity Patient Auxiliary Current
72. Electricity Class and Types of EquipmentClasses 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.
73. Electricity Class of EquipmentClasses of EquipmentAll electrical equipment
is categorized intoclasses according to the method of protectionagainst electric
shock that is used. CLASS I CLASS II CLASS III
74. Electricity Class of EquipmentClass 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.

75. General Electrical Safety

76. CLASS I EQUIPMENT
77. Electricity Class of EquipmentClass 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.
78. Electricity Class of EquipmentClass II equipment The symbol for class II
equipment is 2 concentric squares indicating double insulation as shown below.
79. General Electrical Safety
80. CLASS II EQUIPMENT
81. Electricity Class of EquipmentClass 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.
82. Electricity Types of EquipmentTypes of EquipmentThe degree of
protection for medicalelectrical equipment is defined by the typedesignation.
Type B Type BF Type CF
83. Electricity Types of EquipmentType 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 partsCF 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.
84. Electrical Safety TestsNormal 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.

85. Electrical Safety TestsSingle 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.
86. Electrical Safety TestsSingle Fault Condition
87. Protective Earth Continuity Applicable to Class1, all types Limit 0.2 ohms
88. Insulation Tests Applicable to Class 1, all types Limit Not less than 50Mohms
89. Insulation Tests Applicable to Class II, all types having applied parts Limit : >
50 MOhms
90. Earth Leakage CurrentApplicable to: Class 1 equipment all typesLimits:
0.5mA in NC, 1mA in SFC or 5mA and 10mArespectively for permanently installed
equipment
91. Enclosure Leakage Current Applicable to Class 1 and class II equipment , all
types. Limit0.1mA in NC, 0.5mA in SFC
92. Patient Leakage Current Applicable to All Classes B and BF equipment
having applied parts Limits 0.1mA in NC, 0.5mA in SFC
93. Patient Auxiliary Current Applicable to All equipment having applied parts.
Limits 0.1mA in NC, 0.5mA in SFC
94. 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
95. Safety Test as done by BEMS
96. Electrical Safety ReviewElectrical 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
97. Electrical Safety ReviewReport, tag, and do not use equipment with:
Frayed wires or cracked insulation Damaged plugs or missing ground prongs

98. Electrical Safety ReviewReport, tag, and do not use receptacles with: Only
two slots Missing cover plates Loose mountings Weak gripping force
99. Electrical Safety ReviewInspections of Equipment: - Check of Strain-Relief
100. Electrical Safety ReviewAvoid: 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
101. Electrical Safety ReviewBe 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