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II. Fundamental Concepts of Electrical Safety . . . .page 6
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 32
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 33
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T he field of medical
instrumentation is by no
means new. Many
consequently, much research and
development money went into this
area. The aerospace medicine
instruments were developed programs were expanded
as early as the nineteenth century –
for example, the electro-
cardiograph, first used by
considerably, both within NASA
facilities and through grants to
Universities and Hospital research
Electrical
Einthoven at the end of that
century. Progress was rather slow,
however, until after World War II
units. Some of the concepts ad
features of patient monitoring
systems presently in use in
Safety
when a surplus of electronic hospitals throughout the world
equipment such as amplifiers and evolved from the base of astronaut Made Easy
recorders became available. At that monitoring. The use of adjunct
time, many technicians and fields, such as biotelemetry, also
engineers, both within industry found some basis in the NASA
and on their own, started to programs.
experiment with and modify
existing equipment for medical Also, in the 1960’s, an awareness of
use. This process occurred during the need for engineers and
the 1950’s and the results were
often disappointing. For the
experimenters soon learned that
technicians to work with the
medical profession developed. All
the major engineering technical
I.
physiological parameters are not societies recognized this need by
measured in quite the same way as forming "Engineering Medicine
physical parameters. They also and Biology" subgroups and new
encountered a severe societies were organized, such as
communication problem with the the Biomedical Engineering
medical profession. Society. Along with the medical
research programs at the
During the next decade many
instrument manufacturers entered
universities, a need developed for
courses and curricula in
Introduction
the field of medical instrumenta-
tion, but development costs were
biomedical engineering and today
almost every major university has to Biomedical
high, and the medical profession some type of biomedical
and hospital staffs were suspicious
of new equipment and often
engineering program. However,
much of this effort is not
Engineering
uncooperative. Many develop- concerned with biomedical
ments with excellent potential instrumentation per se.
seemed to have become lost
causes. It was during this period One of the problems of
that some progressive companies "biomedical engineering" is
decided that rather than modify defining it. The prefix bio- of
existing hardware, they would course, denotes something
design medical instrumentation connected with life. Biophysics and
specifically designed for medical biochemistry are relatively old
use. Although it is true that many disciplines in which basic sciences
of the same components were have been applied to living things.
used, the philosophy was changed; One school of thought subdivides
equipment analysis and design bioengineering into different
were applied directly to medical engineering areas – for example,
problems. biomechanics, and bioelectronics.
These categories usually indicate
A large measure of help was the use of that area of engineering
provided by the U.S. government, applied to living rather than to
in particular NASA (National physical components.
Aeronautics and Space Bioinstrumentation implies
Administration). The Mercury, measurement of biological
Gemini and Apollo programs variables, and this field of
needed accurate physiological measurement is often referred to as
monitoring for the astronauts; biometrics, although the latter -1-
term is also used for mathematical responsibly, effectively, and safely
and statistical methods applied to manage and interface with medical
biology. devices, instruments and systems
and the use thereof during patient
I.
ance inspections further reduce
feasible to consider an in-house hospital costs by reducing equip-
BMET program and, thus, these ment down-time for repairs.
facilities were forced to pay for the
OEM contracts.
Inservice & Education
Again, the government became In an effort to satisfy applicable
involved. Federal and state federal and state requirements as
agencies began to require all well as to insure that clinical
hospital facilities to comply with equipment are utilized both safely
stringent safety guidelines for and to their optimum, some BMET
patient related equipment. This shops provide periodic in-service
included a routine electrical safety and education services. This often
program under which all hospital ranges from simple electrical safety
equipment would be tested, lectures to the proper use of a
evaluated and forced to comply newly acquired piece of equipment
with. Typically, the BMET provides for which hospital personnel might
one or more of the following not yet be familiar.
services to hospital facilities:
Electrical Safety Inspections
BMET RESPONSIBILITIES This brings us to the main purpose
of this document. Periodic testing
Corrective Maintenance of patient and non-patient hospital
Non-scheduled repair of hospital equipment to insure that they meet
equipment other than during the safety requirements and guide-
Preventive Maintenance inspec- lines as set fourth by applicable
tions. These repairs range from federal and state regulations. This
replacement of minor parts or in no way measures the equipment
components to total equipment ability to perform the task for
overhauls as may be required. In an which is was designed.
effort to further provide a cost
savings to the hospital facility, HISTORY OF
some BMETs attempt to repair ELECTRICAL SAFETY
equipment to the smallest
component level, rather than The introduction of electricity into
simply replacing circuit boards or commerce at the close of the 19th
sub-assemblies which may be very century carried with it the need to
costly. Other BMETs follow a know how to deal with it safely. For
philosophy that component-level the hospital environment, much of
repair entails far too many risks of the electrical safety programs
repeated failure or improper started after World war II. Shortly
-4- component soldering techniques to thereafter, federal funds via the
Hill-Burton Act increased the hospitals" consumer critic Ralph
number of hospital facilities. Nader said yesterday.
Grounding for electrical safety was
implemented because most During the 1970’s, several
electrical accidents in the home
and industry occurred because
exposed metal was energized. The
proposals and regulations were
introduced to manage this
suspected problem in hospitals. In
Electrical
National Electrical Code stated that
"non-current carrying" metal parts
of the electrical apparatus could
1971, the National Fire Protection
Association published a recom-
mended standard (76BM) to help
Safety
prevent such accidents. hospital engineers understand the
Unfortunately, by the end of the principles of electrical safety and Made Easy
1950’s, electrical power in the coordinate a program of medical
hospitals was supplied in a equipment electrical testing in
haphazard, eclectic fashion. their facilities. In the spring of
1972, Underwriters laboratories
In the hospital environment of the issued document UL544 Medical
sixties, electricity came to be used and Dental Equipment, which was
more often on, in and around intended to serve as a guideline for
patients to a degree beyond
conception only a few years
previously. It was early in 1961 that
medical equipment manufacturers.
In 1970, AAMI (the Association for
the Advancement of medical
I.
there appeared the first news that Instrumentation) published a first-
"microshock" (small electric draft standard for electrical leakage
currents applied to a conductor current standards that was adopted
near the heart) was happening in as an American national standard
the medical field. in 1978.
In 1969, Carl Walter, M.D., who was Probably the most dramatic
at the time a well-known surgeon, proposal was the Joint
stated that, "1,200 patients were Commission on the Accreditation
being accidentally electrocuted in of Hospitals (now the Joint
U.S. hospitals each year." Although Commission on the Accreditation
many engineers and health care of Healthcare Organizations –
professionals believed that Dr. JCAHO) 1976 recommendation that
Walter’s estimates were unreal- hospitals maintain equipment
istically high, the concept of control programs to provide for
microshock suddenly became electrical safety training, create a
publicized. documented preventive main-
tenance program, and perform
Then, on June 16th, 1970, Ralph semi-annual safety and perfor-
Nader (a household word because mance equipment inspections and
of his 1965 book, Unsafe at Any annual inspections of electrical
Speed) gave a speech in Detroit. In receptacles.
this speech, he stated that, "1200
annual electrocutions in US Today, health care institutions in
hospitals was a very least figure" the United States support clinical
and quoted other experts engineering programs that provide
indicating that the real number ongoing electrical safety and
might be significantly higher. The performance testing as well as
event was picked up by a wire preventive maintenance and repair
service and run under an arresting of medical equipment. Typically,
headline the next day: Hospital these programs use the most recent
electrocutions cited Detroit (UPI) – editions of NFPA 70, NFPA 99,
"Accidental electrocutions claim NFPA 101, AAMI Recommended
5,000 lives in American Hospitals Standards, and Joint Commission
every year but seldom get reported accreditation manuals for their
due to the "close nature of reference standards.
-5-
S ome of the most basic
concepts of electricity must
be understood in order to
Where "I" is the current in amperes
that flows through a device or
grasp the potential hazards of conductor, "V" is the magnitude in
BAPCO’S SA2115
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everything you need to
safety test:
• Patient to non-
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-6-
B ecause the amount of
electricity that will flow
through any medium
MACROSHOCK AND
MICROSHOCK
depends on the resistance that
it encounters, current can flow
through the human body and
cause various effects. If direct
The effect of electric shock on the
human body can be anything from
barely perceptible tinges, to muscle
Electrical
current (polarized, nonchanging)
or high frequency alternating
current passes through the body,
spasms, to death. Each can occur
from small or large currents,
depending on how the currents are
Safety
heating effects and ultimately introduced into the body. Large
burns will occur. It is this effect that currents (milliamperes or larger) Made Easy
is intentionally created when that are introduced into the body
electrosurgical generators are used from one external point to another
to cut tissue and coagulate fluids. If (arm to leg, for example) can result
low frequency alternating current is in macroshock. If small currents (as
applied to the body, muscular low as 10 microamperes) are
polarization and depolarization introduced into the body from an
take place that can ultimately external source such as a catheter
create a "circus movement" in the
heart muscle, resulting in
fibrillation and death. It is this
or cardiac pacing wires, the
resistance to the heart muscle can
be very low, and electrocution can
III.
effect that normally accounts for occur from microshock.
death due to electric shock.
The chart below describes the
Unfortunately, the typical effect of different levels of current
resistance of the human body in that are introduced into the human
combination with the frequency of body by creating a voltage across
commercially generated electricity each arm. For microshock, the
(60 hertz) can create a potentially
hazardous situation in the hospital
same effect can be produced with
current levels that are only
Physiological
1/10,000 as great as those listed.
environment.
Effects Of
Electricity
CURRENT EFFECT
-7-
HIGH FREQUENCY EQUIPMENT
EFFECTS SAFETY TESTING
A
Where "I" is the applied current ELECTRICAL SHOCK
III. and "A" is the area that the current
flows through. The three ingredients in the
scenario of electrocution are :
III.
from the resistance of the The Isolation transformer offers
insulation surrounding the power electrical safety by converting
wires and transformer primary grounded power into ungrounded
windings. power. This is accomplished by
grounding the primary winding of
the transformer and not grounding
ELECTRICAL SAFETY the secondary winding. Isolation is
POWER SYSTEM not perfect for two reasons. First,
DEVICES the isolation transformer has some
stray capacitance to ground.
Several techniques are available to Second, every medical device that
protect clinicians and patients is attached to the transformer
from electrical shock. The most possesses stray capacitance which
common ones are the ground fault causes some degree of coupling
circuit interrupter (GFCI), the between its power-carrying wires
isolation transformer and and the grounded frame. To
equipotential grounding. monitor the system isolation, a line
isolation monitor (LIM) is em-
ployed. Its function is to analyze
the entire isolated circuit and
GROUND FAULT quantify its degree of isolation from
CIRCUIT INTERRUPTER ground. The LIM provides visual
and audible alarm signals when the
The GFCI acts like a circuit breaker predicted ground-seeking current
when it senses an inequality of as exceeds a specified magnitude. The
little as 6-ma between the "hot" LIM does not indicate an existing
and neutral wires of the circuit. It is current flow, rather it predicts the
mandated by the national electric current that would flow if a short
code where electrical outlets are so circuit were to develop between
situated that simultaneous contact isolated wire and ground.
with a grounded surface is
especially likely. "Wet locations" In the operating room, isolated
such as a whirlpool bath or power systems were first installed
bathroom are examples of GFCI as a measure directed against
usage. sources of ignition rather than
electrical shock. Flammable
In the GFCI, current in the "hot" anesthetics such as diethyl ether
wire passes through one and cyclo-propane were used.
transformer coil on the same Today, most anesthesiologists use
transformer core. From the design, non-flammable anesthetics and
-10- the net flux is zero, when the isolated power is not required.
EQUIPOTENTIAL and second, safety was blatantly
exploited for ego-serving,
GROUNDING bureaucratic, and commercial
gains.
Another technique that reduces
electrical shock is equipotential
grounding. This is accomplished by
Today, there are two standards that
specify electrical safety: NFPA 99
Electrical
adding another grounding wire
from each chassis to a central point
that is in parallel with the third wire
and the AAMI Standard for Safe
Current Limits. Safety
in the power cord. If the chassis of The 1996 edition of NFPA 99
all equipment is at the same includes numerous technical Made Easy
potential there will be no current changes that relate to leakage
leakage to the heart. This technique current and it now more closely
has its advantages and disadvan- correlates to the international
tages and is not typically used in standards. Originally, NFPA 76B
today’s health care environment. covered the electrical wiring system
and electrical appliances. The
summary of the standard as it
CODES AND
STANDARDS
relates to electrical safety is in the
Table on the following page. III.
One further comment about
In the 1960s, all aspects of hospital standards. On may 30, 1972,
activities involving fire and Underwriter’s laboratories (UL)
explosion hazards (including released the first edition of UL-544,
electrical shock and emergency Standard for Safety for Medical and
electrical power) were seen to be in Dental Equipment. UL-544 deals
need of some guidelines and/or with details regarding enclosure
standards. As it turns out, in the safety, mechanical stability, and
standards arena of the 1970s, integrity of insulation. It’s leakage
patient safety was twice corrupted. current, isolation requirements,
First, standards were generated in and test methods are similar to but
ignorance (solutions were imposed not identical with those of AAMI
before the problems were defined) and NFPA.
-11-
NFPA - 99 1996 AAMI/AAMI ESI
1993
Ground
5000µa
Ground
5000µa 100µa
Ground Ground
Lead to Ground Current Open Intact Open Intact
With Isolated Patient Connection 50µa 10µa 50µa 10µa
With Nonisolated patient Connection 100µa 100µa 100µa 50µa
-13-
SAFE CURRENT LIMITS In addition, this standard does not
apply to apparatus designed
FOR ELECTROMEDICAL primarily for nonmedical
APPARATUS applications and used in
Electrical 1 SCOPE
conjunction with electromedical
apparatus, but located outside of
the patient care vicinity.
2 DEFINITIONS
electromedical apparatus is
powered by a single power cord,
the equipment assembly acts like a For the purposes of this standard,
single apparatus in terms of risk the following definitions apply.
current limit requirements, and
shall be considered as such for the 2.1 accessory
purposes of this standard. The Device produced or recommended
safety and performance criteria by the manufacturer of an electro-
defined in this standard are medical apparatus, and intended to
intended for use in design quali- be electrically connected to that
fication by the device apparatus in order to make the
manufacturer. apparatus useful or to improve its
efficacy or versatility, and not a
NOTE — The referee test methods modular part of that apparatus.
of Section 5 are intended to provide
means by which conformance with 2.2 auxiliary apparatus
the standard can be established. Electromedical apparatus used in
These tests are not intended for use conjunction with other
in verifying the performance of electromedical apparatus to
individual devices in routine achieve a common purpose.
quality assurance inspections. Also,
referee tests allow for the use of NOTE — Auxiliary apparatus
alternative methods for design includes both interconnected
qualification, provided that devices apparatus and noninterconnected
so qualified will also meet the apparatus.
requirements of this standard when
tested in accordance with the 2.3 composite risk current
referee methods. Total risk current derived from the
risk currents of all the apparatus
1.2 Exclusions associated with the patient that can
This standard does not set limits flow through the patient, medical
for the composite risk current staff, or bystander.
when several devices are per-
forming different functions for the NOTE — This definition is included
same patient and are independ- for reference only. A method of
ently connected to the utility power derivation and limits for composite
system. This standard does not risk current are not covered in this
apply to therapeutic currents. standard.
-14-
2.4 electromedical apparatus removed or replaced without
Instrument, equipment, system, or affecting the operation of other
device that directly or indirectly assemblies in the apparatus.
uses electricity for any medical
purpose.
10,000 Ω
0.015 µF
MILLI-
INPUT 1,000 Ω VOLTMETER
100 Ω
Figure 1
AAMI standard test load .
-18-
Patient- Patient
Category Cord- Applied Risk Isolation General Other
Electrical
Connected/ Perma- Current Risk Current Cord- Cord- Perma-
Battery- nent (source (sink connected connected)1 nent2)
current) current)
Normal
Condition
ISOLATED
Single Fault
100 mA 100 mA 10 mA N/A 500 mA 2,500 mA 5,000 mA
Safety
Condition 300 mA 5,000 mA 50 mA 50 mA 1,000 mA 5,000 mA 10,000 mA Made Easy
Normal
Condition 100 mA 100 mA 10 mA N/A 500 mA 2,500 mA 5,000 mA
NON-ISOLATED
Single Fault
Condition 300 mA 5,000 mA 100 mA N/A 1,000 mA 5,000 mA 10,000 mA
Normal
Condition 100 mA 100 mA N/A N/A 500 mA 2,500 mA 5,000 mA IV.
LIKELY TO CONTACT PATIENT
Single Fault
Condition 300 mA 5,000 mA N/A N/A 1,000 mA 5,000 mA 10,000 mA
Normal
Condition 100 mA 100 mA N/A N/A 500 mA 2,500 mA 5,000 mA
NO PATIENT CONTACT
Single Fault
Condition 500 mA 5,000 mA N/A N/A 1,000 mA 5,000 mA 10,000 mA
Table 1
Summary of risk current requirements in rms microamperes (dc to 1 kHz)
-19-
4.4 Patient-applied risk current 4.5.2 Risk current limits
(source current)2) Limits for patient isolation risk
current for electromedical
4.4.1 General apparatus with isolated patient-
and (a), (b), (c), and (d) listed above NOTE — Not applicable to double
when measured with the AAMI insulated devices using a two-wire
standard test load. power cord.
Safety
Made Easy
1 mA
5.3.1 Application
The risk current shall be measured The enclosure risk current tests
from an electrically conductive foil shall apply to cord-connected, line-
the size of the enclosure, but not to powered apparatus, to battery-
exceed 200 cm2, in immediate powered apparatus with the
contact with the enclosure. The foil charger connected, and to
shall be placed at a location— permanently connected apparatus.
determined by experimentation—
such that the current measured to 5.3.2 Cord-connected, normally
power ground (earth) is a grounded apparatus
maximum. If exposed chassis
hardware is likely to be touched by 5.3.2.1
personnel, then the hardware shall Using the test circuit of Figure 3,
be treated as an exposed the enclosure risk current shall be
electrically conductive surface. measured:
Testing of nonconductive exposed
surfaces of patient wiring and a) between enclosure and power
cables is not required. ground (earth);
b) between electrically
5.2.2.3 Controls conductive surfaces and
During risk current tests, all power ground (earth);
operator-accessible controls shall c) between a 200 cm2 foil in
be adjusted to yield the largest risk contact with the non-
current found by experiment. If the conducting enclosure and
electromedical apparatus normally power ground (earth).
Reversing
Switch
200 cm2 fail
S1
Rated
Line Apparatus Select
Voltage Under Per
+10% Test 5.3.2.1
Ground M
Ground Switch
S2 Ground Wire Exposed
Conductive Surface Risk Current
Tester
-22-
Figure 3 — Enclosure risk current test circuit (normally grounded)
NOTE — The 200 cm2 foil line 5.3.3
leading from the "select" box to the Cord-connected, normally
apparatus under test refers to the ungrounded apparatus
connective mode with insulated
apparatus. The line with an arrow
leading from the "select" box to the
apparatus under test refers to
5.3.3.1
Using the test circuit of Figure 4
(see next page), the enclosure risk
Electrical
connections made with conductive
enclosure.
current shall be measured:
Exposed
Conductive Surface
Ground
5.4.2.2
5.4.2 Apparatus with isolated Each measurement is performed
patient connection when:
120K
Select Per
6.4.2.2.d 120V / 60Hz
Reversing
Patient
Switch
Connection
S1
Rated Line Select Per
Apparatus
Voltage 5.3.2.1
Under
+10%
Test
-24-
Figure 5 — Patient-applied risk current test circuit
d) line voltage is applied to an other external electrical connection
input or output part or to on the apparatus grounded. This
accessible conductive hard- test shall be performed with the
ware of the enclosure, if not apparatus both on and off and
grounded under normal
conditions. These are single
fault conditions;
properly connected to its electrical
supply. The patient cable shall be
placed 20 cm away from a
Electrical
e) each barrier of double
insulation is short circuited.
These are single fault con-
grounded surface.
1:1
Ground
Risk Current
Tester
Protective
Earth Risk
(Ground Current
Conductor) Tester
Relative
0 frequency
characteristics of
millivoltmeter
-20 reading in AAMI
standard test
load of Figure 1
-40
-26- 10 101 102 103 104 105
A.1 General the electromedical apparatus itself.
The rationale discusses the need The standard does not require
for the standard and describes the nonisolated patient connections to
basic underlying principles, carry any special labeling.
empirical data, assumptions, and
sources that support the
requirements and test methods
Electrical
adopted in the standard.
-27-
In its review of the allowable risk disturbance in rhythm in
current levels, the committee humans was 80 mA. In a
considered the following: second study, Watson
a) Likelihood of stimulation of (1973) found that the
Starmer 60 Hz D = 1.25mm
Watson 60 Hz D = 2.0mm
99.9
99
95 +
Cumulative Percent
+
90
+
+
+
50 +
+
+
20
+
5 +
0.1
0 50 100 150 200 250 300 350 400 450 500
Microamperes
Figure A.1 — Normal probability plot
-30-
A.4.5 Patient isolation risk current ground (earth). Contact with such
(sink current) elements and a second device
The 50 mA SFC value for isolated under test will result in current
equipment was allowed because of flow. Thus, the committee felt that
the low probability of line voltage
appearing on a patient, and
because of the low probability of
leaving the earth risk current
unmeasured and unlimited con-
stituted a potential hazard that
Electrical
50 mA inducing ventricular
fibrillation. For line voltage to
appear on a patient, a power
should be avoided.
Electrical DALZIEL, CF. Reevaluation of lethal electric currents. IEEE Trans Indus
Gen Appl, GA-4, 1968, vol. 1, no. 5, p. 467-476.
Safety GEDDES, LA. and BAKER, LE. Response to the passage of electric currents
through the body. J Assn Adv Med Instrum, 1971, vol. 5, p. 13-18.
IV. RAFTERY, EB., GREEN, HL., and YACOUB, MH. Disturbances of heart
rhythm produced by 50 Hz leakage currents in human subjects.
Cardiovascular Research, March 1975, vol. 9, no. 2, p. 263-265.
STARMER, CF. and WHALEN, RE. Current density and electrically induced
ventricular fibrillation. J Assn Adv Med Instrum, 1973, vol. 7, no. 1, p. 3-6.
Bibliography WATSON, AB., WRIGHT, JS., and LAUGHMAN, J. Electrical thresholds for
ventricular fibrillation in man. Med J Australia, 1973, vol. 1, p.1179-1182.
1-800-419-4000
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-32-
FREQUENCE: The number of oscillations, per unit of to a patient, but may be conveyed from exposed metal