Electro-medical Safety

SECTION 1: INTRODUCTION

A. Cause of hazards
1. due to energy delivered when functioning properly
2. in case of fault condition
3. due to absence of function

B. The hazards can imposed upon

1. the patient
2. the operator
3. the surrounding personnel
4. the equipment

C. Reasons for care of biomedical safety

1. inability to detect the presence of certain potential hazards e.g.
ionising or high frequency radiation
2. absence of normal reaction of the patient
3. absence of normal protection to current provided by skin
4. support or replacement of vital body functions may depend on the
reliability of equipment
5. more than one piece of mains operated equipment are connected
6. combination of high power equipment and sensitive low signal
equipment
7. direct application of electrical circuits to the human body
8. environmental conditions

D. Illustration of hazards
1. electrical hazards:- 3 majors effects- i) electrolysis
ii) stimulation of tissue
iii) tissue heating
1.1. low frequency < or = 0.1 Hz A.C.
- electrolysis may occur
1.2. low frequency < or = 1 KHz A.C.:
- excite the muscle and neural cells
- microshock, ventricular fibrillation
- electrocution
1.3. radio frequency burn
2. mechanical hazard e.g.electrical bed
3. radiation hazard
4. explosion hazard
5. temperature or fire hazard
- applied part not intended to supply heat should not have
surface temp. exceeding 41oC
- burning insulation, flaming particles and molten metal should
 not fall out of equipment
6. chemical hazard:
e.g. copper in dialysate cause haemolysis, nitrous oxide may have high
risk of spontaneous abortions and congenital abnormality in children as
well as disease of the liver, kidney and CNS, drug may interact with
rubbers, plastics such as catheter, syringes
7. human error/negligence hazard
8. equipment fault hazard
9. system incompatibility hazard

SECTION 2:- BASIC ELECTRICITY

A. units-voltage (V) (force or potential) - in volt (V)

current (I) - in ampere (A)
resistance (R) - in Ohm (Ω )

B. Ohm's law:- V = I x R (voltage = current x resistance)

means that a potential of 1 V will be developed across a resistor of 1 Ω , if a
current of 1 A flows through it

C. power is expressed in watt (W) or VA, energy in joule

power = voltage x current (W = V x I)
energy = power x time (joule = W x T)
1 KWH = 1 x 1000 watt x 3600 sec

D. conductor, semi-conductor, insulator

direct current (D.C) - primary (dry) cell, secondary (rechargeable) cell
alternating current (A.C) - supply system in H.K. is 3 phase earthed neutral
i.e. 346V +/- 6%, for 3 phase, 200V +/- 6% for single phase, 50Hz +/- 2%

E. electrical protection device: - protect from overheating, damage surrounding

insulation, start a fire or electric shock
1. fuse
2. circuit breaker - miniature circuit breaker, earth leakage circuit breaker,
residual current circuit breaker

F. plug, socket, adapter and power cable

1. plug and socket- are of 13A rating, other appropriate rated plugs are 5A,
15A
2. adapter- bridge between plug and socket, -multi-purpose adapter is not
encouraged to be used
3. adapter may be a step down transformer -multi-voltage adapter is not
recommended
4. power cable -2 conductor or 3 conductor type - size is determined by the
rating of the equipment - length should not be too long so as to cause
excessive voltage drop along the cable
 5. conductor U.K USA
live(hot) brown black
neutral blue white
earth yellowish green green

for 3 phase operation,

live:- red, yellow and blue respectively
neutral:- green
earth:- yellowish green

SECTION 3:- CLASSIFICATION AND TYPE OF MEDICAL ELECTRICAL

EQUIPMENT

A. Terminology
1. applied parts- the parts which come intentionally into contact with the pt.
2. patient circuit- electrical circuit of which the pt. forms a part
3. basic insulation- insulation applied to live part
4. double insulation- insulation comprising both basic and supplementary
insulation
5. mains part- parts intended to have a conductive connection with the
supply mains
6. high voltage- any voltage over 1000V A.C or 1500V D.C or 1500V peak
value
7. medical safety extra low voltage(MSELV)- a voltage which does not
exceed a nominal value of 24V A.C or 50V D.C
8. F-type isolated(floating) applied part- applied part isolated from all other
parts of the equipment to such a degree that the allowable patient leakage
current under single fault condition is not exceeded when 1.1 times the
highest rated mains voltage is applied between the applied part and earth.
(<<500uA)

B. Class of equipment- means of protection to electric shock

1. class I equipment- basic insulation + earthed
2. class II equipment- double insulation or reinforced insulation
3. class III equipment- MSELV

C. Type of equipment- degree of protection against electric shock

1. type B equipment- class I, II, III equipment of earthed and no applied parts
2. type BF equipment- type B equipment with F-type isolated(floating)
applied parts not directly to heart
3. type CF equipment- for direct cardiac application e.g. use battery

D. Other classification
1. drip proof equipment, splashproof equipment, watertight equipment
2. sterilizable equipment
 3. anaesthetic proof equipment

E. light indication
red- alarm, amber- alert, green- power on

SECTION 4:- PHYSIOLOGICAL EFFECT OF ELECTRICITY

A. 3 primary effects to human body

1. injuring tissue
2. causing uncontrollable muscle contraction or unconscious
3. producing fibrillation of heart

B. Tissue injuring from high current - burning or destroying tissue in the path -by
heating, charring or electrolysis

C Physiological response to moderate current

1. excite muscle and nerves
2. may cause cessation of respiration
3. current passes thro' the brain may cause convulsion
4. damage the CVS and respiration centre
5. a very short period of time cannot produce excitation
6. most vulnerable frequency is 60 to 100 Hz
7. high frequency and short duration cannot excite

D. Cardiac fibrillation resulting from small currents applied to heart

1. low resistance pathways to the heart
2. produce fibrillation

E. Human sensitivity to current frequency

1. tongue- 45 uA - 60Hz
2. hand- 0.4 mA at 60Hz to 56mA at 50KHz
3. "let go" current- 18.57mA and 10.5mA for men and women
respectively at 60Hz
4. feel threshold- 0.5 to 1 mA
5. most dangerous current is between 50 to 60Hz

F. Lethal current level- to produce ventricular fibrillation

- lowest is 180 uA thro' heart

G. Impedance of the human body

- hand - 200 KOhm
- heart -1000 Ohm
SECTION 5:- ELECTRIC SHOCK AND EARTHING

A. Electric shock
1. macroshock
- relative large amount of current flows across a person's body
- only a small portion of total applied current pass through the heart
- neither point of contact is directly connected to the heart
- 75 to 400 mA, ventricular fibrillation occurs
2. microshock
- at least one contact on or within the heart
- bypass the protective resistance of the skin and current was
concentrated thro' the heart
- 180 uA can cause fibrillation
- generally accepted safety limit is 10 uA

B. Macroshock hazards
1. electrical fault
2. protection by earthing

C. Microshock hazards
1. leakage current in line-operated equipment
2. leakage current (small current that inevitably flow between any adjacent
insulated conductors) that are at different potentials
3. differences in voltage between earthed conductive surfaces
4. potential difference between 2 earth point
5. prefer to have earthing arrangement in equipotential earthing system

SECTION 6:- RECOMMENDED SAFETY PRACTICES IN THE HOSPITAL

1. inspect the power cord and plug before use

2. check the condition of the wall outlets whenever plugs are inserted or removed
3. use only 3-pin plugs
4. never pull the plug by yanking on the cord
5. avoid using extension cords or adapters
6. switch off the equipment before removing the plug from the socket outlet
7. .for equipment with detachable power cord, never disconnect the female
connector of the cord without having removed the plug from the A.C socket
8 .never stack things on or behind the equipment
9 .do not use equipment on which liquid have been spilled and do not rest
equipment in wet locations
10 whenever possible keep equipment as far from the patient's bedside as possible
11 try not to touch the patient and an electrical appliance at the same time because
you can conduct current
12 always handle with dry hands
13 ensure that the interconnection cables, leads of the equipment are properly
connected and placed properly
14 immediately disconnected electrical equipment when there is fire, smoke or shock
15 ask at any time if you are in doubt notify the technical personnel for inspection

SECTION 7:- SAFE USE OF ELECTRICALLY OPERATED BIOMEDICAL

EQUIPMENT

A. General precaution
1 interconnection of equipment - to right connector
- correct interconnecting cable
- what is at the other end of the lead they are connecting
- correct polarity
2. correct handling of equipment after severe shock
- equipment subjected to severe shock should not be used
- thorough check
3. overcharge of battery
- exceeds 100 hours
- shorten battery life, cell explosion
4. muting of alarm
- never try to mute the alarm
- find out the cause and solve
5. test equipment before use

B. Specific precaution- according to the individual equipment