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Electrical
Safety
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 1
Industry Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 3
BMET Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 4
History of Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . .page 4
Made Easy
II. Fundamental Concepts of Electrical Safety
. . . .page 6
Table Of
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 7
Macroshock and Microshock . . . . . . . . . . . . . . . . . . . . . . . . .page 7
High Frequency Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 8
Potential Equipment Safety Hazards . . . . . . . . . . . . . . . . . . .page 8
Equipment Safety Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 8
Electrical Shock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 8
The Electrical Power System . . . . . . . . . . . . . . . . . . . . . . . . . .page 8
Contact with a Ground . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 9
Skin Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 9
Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 10
Electrical safety Power System Devices . . . . . . . . . . . . . . . .page 10
Ground Fault Circuit Interrupter . . . . . . . . . . . . . . . . . . . . .page 10
Isolation Transformer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 10
Equipotential Grounding . . . . . . . . . . . . . . . . . . . . . . . . . . .page 11
Codes and Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 11-12
www.bapcoinfo.com
. . . . . . . . . . . . . . . . . . . . . . . . . .page 13-32
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 33
he field of medical
instrumentation is by no
means new. Many
instruments were developed
as early as the nineteenth century
for example, the electrocardiograph, first used by
Einthoven at the end of that
century. Progress was rather slow,
however, until after World War II
when a surplus of electronic
equipment such as amplifiers and
recorders became available. At that
time, many technicians and
engineers, both within industry
and on their own, started to
experiment with and modify
existing equipment for medical
use. This process occurred during
the 1950s and the results were
often disappointing. For the
experimenters soon learned that
physiological parameters are not
measured in quite the same way as
physical parameters. They also
encountered a severe
communication problem with the
medical profession.
During the next decade many
instrument manufacturers entered
the field of medical instrumentation, but development costs were
high, and the medical profession
and hospital staffs were suspicious
of new equipment and often
uncooperative. Many developments with excellent potential
seemed to have become lost
causes. It was during this period
that some progressive companies
decided that rather than modify
existing hardware, they would
design medical instrumentation
specifically designed for medical
use. Although it is true that many
of the same components were
used, the philosophy was changed;
equipment analysis and design
were applied directly to medical
problems.
A large measure of help was
provided by the U.S. government,
in particular NASA (National
Aeronautics and Space
Administration). The Mercury,
Gemini and Apollo programs
needed accurate physiological
monitoring for the astronauts;
Electrical
Safety
Made Easy
I.
Introduction
to Biomedical
Engineering
-1-
Electrical
Safety
Made Easy
I.
-2-
INDUSTRY REGULATION
In its infancy, biomedical equipment was best serviced and
maintained by the original
equipment manufacturer as there
were few, if any, qualified
technicians who could do so
adequately. A lack of standards
linking the technology, an absence
of service literature, and the
general feeling from hospital
personnel that, unless trained by
these OEMs, no one would be able
to provide a suitable level of
services. Thus the early BMET was
relegated to maintain and repair
only the simplest of clinical
equipment such as centrifuges,
suction pumps and other such
equipment. Several factors soon
arose to alter this conception. First,
agencies such as the Food and
Drug Administration (FDA)
developed subdivisions under
which fell the area of medical
instrumentation. This brought
about a set of standards and
practices for manufacturing of
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-3-
Electrical
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I.
BMET RESPONSIBILITIES
Corrective Maintenance
-4-
Preventative
Maintenance Inspections
Periodic testing and evaluation of
patient and non-patient related
equipment to insure that they
operate within the guidelines set
fourth by federal, state and
manufacturer guidelines. This
includes calibration and alignment
of said equipment along with the
repair and/or replacement of
component parts in order to bring
the equipment into compliance. It
is the belief of most BMETs that
good, quality preventive maintenance inspections further reduce
hospital costs by reducing equipment down-time for repairs.
HISTORY OF
ELECTRICAL SAFETY
The introduction of electricity into
commerce at the close of the 19th
century carried with it the need to
know how to deal with it safely. For
the hospital environment, much of
the electrical safety programs
started after World war II. Shortly
thereafter, federal funds via the
Electrical
Safety
Made Easy
I.
Electrical
Safety
Made Easy
The Nature of Electricity
II.
Fundamental
Concepts Of
Electrical
Safety
I=V
R
BAPCOS SA2115
Safety Certifier
is the most complete
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everything you need to
safety test:
Patient to nonpatient, medical to
commercial devices
110 V @ 200amp
to 240V @ 15 amp
Automatically
to AAMI standards
-6-
Power (watts) =
(V) (I) = (120)
(3) = 360 Watts
MACROSHOCK AND
MICROSHOCK
The effect of electric shock on the
human body can be anything from
barely perceptible tinges, to muscle
spasms, to death. Each can occur
from small or large currents,
depending on how the currents are
introduced into the body. Large
currents (milliamperes or larger)
that are introduced into the body
from one external point to another
(arm to leg, for example) can result
in macroshock. If small currents (as
low as 10 microamperes) are
introduced into the body from an
external source such as a catheter
or cardiac pacing wires, the
resistance to the heart muscle can
be very low, and electrocution can
occur from microshock.
The chart below describes the
effect of different levels of current
that are introduced into the human
body by creating a voltage across
each arm. For microshock, the
same effect can be produced with
current levels that are only
1/10,000 as great as those listed.
CURRENT
EFFECT
Ventricular fibrillation
>5 Amps
Electrical
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Physiological
Effects Of
Electricity
-7-
Electrical
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HIGH FREQUENCY
EFFECTS
EQUIPMENT
SAFETY TESTING
This relationship is :
Heat = I x I
A
III.
POTENTIAL
EQUIPMENT
SAFETY HAZARDS
Because current flow through the
body can be hazardous if it is of a
certain amplitude and frequency,
stray currents must be eliminated
from medical equipment. The best
method to prevent leakage currents
is to ensure that all conductive
parts of the equipment are connected to the hospital grounding
system through the power plug.
Also, to minimize patient contact
with current leakage on ECG signal
leads, electrically isolated
amplifiers should be used.
-8-
ELECTRICAL SHOCK
The three ingredients in the
scenario of electrocution are :
1. contact with the live
conductor of a grounded
electrical system
2. contact with a ground
3. diminished skin resistance
THE ELECTRICAL
POWER SYSTEM
Domestic voltages in the United
States are from 120V for lighting
and small appliances, and 240V for
electrical ranges and dryers. In the
hospital, outlets are 120V while
277V and 208V are often used for
fixed lighting and special
receptacles.
Typically, a voltage of 240V is
provided by the service drop to the
power meter of the hospital. This
line consists of a bare cable plus
two wires having black insulation.
The bare cable is connected to
"earth" ground via a water pipe or
grounding rod. It is this connection
that makes the electrical service a
grounded system.
NOTE : The national electric Code defines
ground as "a conducting connection,
whether intentional or accidental, between
an electrical circuit or equipment and the
earth, or to some conducting body which
serves in place of the earth."
CONTACT WITH
A GROUND
For purpose of illustration, we will
use an electrocardiograph (ECG) as
our example of a medical device.
Back in the 1950s, the standard
ECG was fitted with a two-prong
plug. The patient was connected to
the chassis ground via the right-leg
electrode, and one wire of the
power cord was connected to the
chassis through a 200,000-Ohm
resistor. This connected the chassis
to ground via the natural conductor in the power system. If the
plug was inserted with polarity
reversed, then the patient was
connected to the "hot" side of the
power system. However, the 200KOhm built-in resistor limited the
current to 0.6 milliamperes if the
patient or bystander provided a
pathway to ground. Added safety to
the machine included a fivemilliamp fuse in series with the
right-leg electrode. As it turns out
this approach was not practical
because the fuse kept blowing after
the patient was defibrillated.
The codes changed this practice
and todays ECG machines do not
ground any of the electrodes to
earth ground. In fact, the "front
end" electronics on most medical
SKIN RESISTANCE
Water affects skin resistance, and
for a given voltage, resistance
determines current. When dry, skin
has a resistance of upwards
100,000 ohms. If there is an
accidental application of 120 volts
between the two hands, only
1.2 milliamperes will flow. In a wet
environment or on a hot and
humid day, that same current path
may come to have a resistance as
low as 1,000 ohms, resulting in a
current flow of 120 milliamperes.
Electrical
Safety
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If a patient is exposed to
electrical current, it takes about
1 milliampere of 60 Hz AC for a
threshold of sensation. The
sensation becomes uncomfortable
if 5 milliamperes is attained. Strong
muscle spasms appear at currents
of 10 to 20 milliamperes ("let-go"
current before sustained muscular
contraction). A current flow of
100 milliamperes or greater may
induce ventricular fibrillation and
death. These values are for currents
introduced at the body surface.
They are termed macroshocks and
require two points of external body
contact.
There is a possibility of a direct
electrical path to the heart via a
needle or catheter in an artery or
vain. This directly reduces the
resistance and current threshold.
Small amounts of current
(100 microamperes) can be
potentially lethal. Electrical shock
in these circumstances is termed
"microshock".
The frequency of the current is also
important when considering
electrical shock. If the frequency is
raised above 1 KHz, these current
levels no longer produce such
sensations or life-threatening
phenomenon. High frequencies in
the megahertz region will not cause
shock at all.
-9-
LEAKAGE CURRENT
Electrical
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ELECTRICAL SAFETY
POWER SYSTEM
DEVICES
Several techniques are available to
protect clinicians and patients
from electrical shock. The most
common ones are the ground fault
circuit interrupter (GFCI), the
isolation transformer and
equipotential grounding.
GROUND FAULT
CIRCUIT INTERRUPTER
The GFCI acts like a circuit breaker
when it senses an inequality of as
little as 6-ma between the "hot"
and neutral wires of the circuit. It is
mandated by the national electric
code where electrical outlets are so
situated that simultaneous contact
with a grounded surface is
especially likely. "Wet locations"
such as a whirlpool bath or
bathroom are examples of GFCI
usage.
-10-
ISOLATION
TRANSFORMER
The Isolation transformer offers
electrical safety by converting
grounded power into ungrounded
power. This is accomplished by
grounding the primary winding of
the transformer and not grounding
the secondary winding. Isolation is
not perfect for two reasons. First,
the isolation transformer has some
stray capacitance to ground.
Second, every medical device that
is attached to the transformer
possesses stray capacitance which
causes some degree of coupling
between its power-carrying wires
and the grounded frame. To
monitor the system isolation, a line
isolation monitor (LIM) is employed. Its function is to analyze
the entire isolated circuit and
quantify its degree of isolation from
ground. The LIM provides visual
and audible alarm signals when the
predicted ground-seeking current
exceeds a specified magnitude. The
LIM does not indicate an existing
current flow, rather it predicts the
current that would flow if a short
circuit were to develop between
isolated wire and ground.
In the operating room, isolated
power systems were first installed
as a measure directed against
sources of ignition rather than
electrical shock. Flammable
anesthetics such as diethyl ether
and cyclo-propane were used.
Today, most anesthesiologists use
non-flammable anesthetics and
isolated power is not required.
EQUIPOTENTIAL
GROUNDING
Another technique that reduces
electrical shock is equipotential
grounding. This is accomplished by
adding another grounding wire
from each chassis to a central point
that is in parallel with the third wire
in the power cord. If the chassis of
all equipment is at the same
potential there will be no current
leakage to the heart. This technique
has its advantages and disadvantages and is not typically used in
todays health care environment.
CODES AND
STANDARDS
In the 1960s, all aspects of hospital
activities involving fire and
explosion hazards (including
electrical shock and emergency
electrical power) were seen to be in
need of some guidelines and/or
standards. As it turns out, in the
standards arena of the 1970s,
patient safety was twice corrupted.
First, standards were generated in
ignorance (solutions were imposed
before the problems were defined)
Electrical
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-11-
NFPA - 99 1996
Electrical
Safety
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III.
Ground
Open
Ground
Intact
300a
300a
300a
100a
300a
300a
300a
100a
300a
300a
300a
100a
No patient Contact
300a
300a
300a
100a
Ground
Open
Ground
Intact
Ground Ground
Open
Intact
5000a
5000a
5000a
100a
5000a
5000a
5000a
100a
5000a
5000a
5000a
100a
No patient Contact
5000a
5000a
5000a
100a
Ground
Open
Ground
Intact
Ground Ground
Open
Intact
50a
10a
50a
10a
100a
100a
100a
50a
Ground
Open
Ground
Intact
50a
10a
n/a
n/a
50a
50a
n/a
n/a
Ground
Open
Ground
Intact
n/a
20a
n/a
n/a
50a
50a
n/a
n/a
Ground
Open
Ground
Intact
Ground Ground
Open
Intact
Ground
Intact
Ground Ground
Open
Intact
Ground
Open
4 Oz
Ground
Intact
Ground Ground
Open
Intact
Ground
Open
Ground
Intact
Ground Ground
Open
Intact
Ground Impedance
0.5 Ohms
Existing System
0.2 Ohms
New Construction
0.1 Ohms
Receptacle Indicators
Ground
Open
Hospital Grade
Emergency System
Isolated Ground
Retention Force,
Ground Blade
-12-
AAMI/AAMI ESI
1993
Ground Ground
Open
Intact
Ground Ground
Open
Intact
Ground Ground
Open
Intact
Listed
Red
Orange
6mA
Electrical
Safety
Made Easy
IV.
The AAMI
Standard For
Safe Current
Limits For
Electromedical
Apparatus
-13-
Electrical
Safety
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IV.
-14-
1.2 Exclusions
This standard does not set limits
for the composite risk current
when several devices are performing different functions for the
same patient and are independently connected to the utility power
system. This standard does not
apply to therapeutic currents.
2 DEFINITIONS
For the purposes of this standard,
the following definitions apply.
2.1 accessory
Device produced or recommended
by the manufacturer of an electromedical apparatus, and intended to
be electrically connected to that
apparatus in order to make the
apparatus useful or to improve its
efficacy or versatility, and not a
modular part of that apparatus.
2.2 auxiliary apparatus
Electromedical apparatus used in
conjunction with other
electromedical apparatus to
achieve a common purpose.
NOTE Auxiliary apparatus
includes both interconnected
apparatus and noninterconnected
apparatus.
2.3 composite risk current
Total risk current derived from the
risk currents of all the apparatus
associated with the patient that can
flow through the patient, medical
staff, or bystander.
NOTE This definition is included
for reference only. A method of
derivation and limits for composite
risk current are not covered in this
standard.
Electrical
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IV.
Electrical
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IV.
3 CLASSIFICATION OF
ELECTROMEDICAL
APPARATUS AND
MEASUREMENT
CONDITIONS
-16-
3.1 Classification of
electromedical apparatus
For purposes of this standard, four
categories of electromedical
apparatus have been defined. For
each category, risk currents are
established. These four categories
are listed below :
a) Electromedical apparatus with
isolated patient connection:
Electromedical apparatus
intended to be connected to
the patient with the patient
circuit isolated from power
ground (earth), utility power
systems, and other circuitry.
b) Electromedical apparatus
with nonisolated patient
connection: Electromedical
apparatus intended to be
connected to the patient.
c) Electromedical apparatus
likely to contact the patient:
Electromedical apparatus that
does not have a patientapplied part, but that is
intended for use in the patient
care vicinity.
NOTE See Section 2 for
definition of patient care vicinity.
d) Electromedical apparatus with
no patient contact:
Electromedical apparatus that
is intended for use outside the
patient care vicinity and that
has no patient connections.
3.2 Classification of
measurement conditions
The following Sections define
normal and fault conditions.
3.2.1 Normal operating conditions
Under normal operating
conditions, a device is operating as
designed with all means provided
for protection against safety
hazards intact, connected properly
and securely to an approved power
source and, if the device includes
patient-applied parts, with such
parts applied according to the
manufacturer's instructions. The
following are considered normal
operating conditions:
4 REQUIREMENTS
4.1 Labeling and documentation
requirements
4.1.1 Isolated patient
connections (labeling)
Patient connections that meet the
requirements of this standard for
isolated patient connections shall
be identified as being isolated at
the connector of the apparatus.
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-17-
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IV.
NOTES :
1) The frequency-weighted
network compensates for the
allowable increase in risk
current limits with increasing
frequency. For measurement
purposes with a voltmeter as
shown, the limit remains
constant at 1 mA/mV,
independent of frequency.
With the meter connected, the
entire circuit is called the "risk
current tester."
2) Refer to Section 5.7.2 for
component requirements and
tolerances.
4.3.2 Risk current limits
Limits for enclosure risk current for
all categories of electromedical
apparatus, whether batterypowered, cord-connected, or
permanently connected, and under
both normal and single fault
conditions, are shown in Table 1 on
next page.
10,000
0.015 F
INPUT
MILLIVOLTMETER
1,000
100
Figure 1
AAMI standard test load .
-18-
Category
Normal
Condition
PatientPatient
CordApplied Risk Isolation
General
Other
Connected/ PermaCurrent Risk Current CordCordPermaBatterynent
(source
(sink
connected connected)1 nent2)
current)
current)
100 mA
100 mA
10 mA
N/A
500 mA
2,500 mA 5,000 mA
ISOLATED
Single Fault
Condition
300 mA
5,000 mA
50 mA
50 mA
1,000 mA
5,000 mA 10,000 mA
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
100 mA
N/A
N/A
500 mA
2,500 mA 5,000 mA
N/A
N/A
1,000 mA
5,000 mA 10,000 mA
Normal
Condition
Normal
Condition
100 mA
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
Electrical
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Table 1
Summary of risk current requirements in rms microamperes (dc to 1 kHz)
2) Equipment specified to be
permanently installed with a
protective power ground
(earth) that is electrically
connected and secured at a
specific location so that the
connection can only be
loosened or moved with the
aid of a tool.
-19-
Electrical
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4.4.1 General
Patient-applied risk current, when
measured with the AAMI standard
test load, is that current that flows
between any patient-applied part
and :
a) power ground (earth);
b) exposed chassis conductive
surfaces or hardware;
c) a 200 cm2 foil in contact with
a nonconducting enclosure; or
d) any other patient-applied
parts.
Patient-applied risk current is also
that current that flows between all
patient connections tied together
and (a), (b), (c), and (d) listed above
when measured with the AAMI
standard test load.
NOTES :
5 Tests
This Section contains referee tests
and procedures by which
compliance with the requirements
of Section 4 and Table 1 can be
determined.
WARNING These tests can
expose personnel to hazardous
electric shock and must be carried
out with caution.
Electrical
Safety
100 mA
NORMALIZED CURRENT
Made Easy
1 mA
500 Hz
1000 Hz
10 KHZ
100 KHZ
1 MHZ
10 MHZ
FREQUENCY (HZ)
IV.
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5.2.2.1 General
First, the apparatus shall be
disconnected from all other
apparatus except auxiliary
apparatus, modular apparatus, or
accessories, as defined in the
normative definitions (see Section
2). A single- or multi-function
apparatus in a cabinet or in
multiple cabinets with a single
power cord connection is tested as
a single apparatus. Each individual
apparatus shall also be tested
independently if described by the
manufacturer as a stand-alone
apparatus. Tests shall be conducted at the rated line voltage
plus 10 percent.
5.2.2.2 Nonconducting enclosure
The risk current shall be measured
from an electrically conductive foil
the size of the enclosure, but not to
exceed 200 cm2, in immediate
contact with the enclosure. The foil
shall be placed at a location
determined by experimentation
such that the current measured to
power ground (earth) is a
maximum. If exposed chassis
hardware is likely to be touched by
personnel, then the hardware shall
be treated as an exposed
electrically conductive surface.
Testing of nonconductive exposed
surfaces of patient wiring and
cables is not required.
5.2.2.3 Controls
During risk current tests, all
operator-accessible controls shall
be adjusted to yield the largest risk
current found by experiment. If the
electromedical apparatus normally
Reversing
Switch
S1
Rated
Line
Voltage
+10%
Apparatus
Under
Test
Select
Per
5.3.2.1
Ground
M
Ground Switch
S2
-22-
Ground Wire
Exposed
Conductive Surface
Risk Current
Tester
Rated Line
Voltage
+10%
Reversing
Switch
S1
5.3.3
Cord-connected, normally
ungrounded apparatus
5.3.3.1
Using the test circuit of Figure 4
(see next page), the enclosure risk
current shall be measured:
a) between enclosure and power
ground (earth);
b) between electrically conductive surfaces and power
ground (earth);
c) between a 200 cm2 foil in
contact with the nonconducting enclosure and
power ground (earth).
5.3.3.2
Each measurement is performed
when:
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200 cm2
fail
Apparatus
Under
Test
Select
Per
5.3.2.1
Risk Current
Tester
Exposed
Conductive Surface
Ground
-23-
Electrical
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5.3.4 Permanently
connected apparatus
Before line-powered apparatus is
permanently installed, the
enclosure risk current shall be
measured according to the
procedures described in 5.3.2.
5.4 Patient-applied risk current
(source current)
IV.
5.4.1 Application
The patient-applied risk current
tests of this Section shall apply to
line-powered and battery-powered
electromedical apparatus that has a
patient connection(s).
120K
Select Per
6.4.2.2.d
Reversing
Switch
S1
Rated Line
Voltage
+10%
Ground Switch
S2
120V / 60Hz
Patient
Connection
Apparatus
Under
Test
200 cm2
fail
Select Per
5.3.2.1
Select Per
5.3.2.1
Exposed
Conductive Surface
-24-
Risk Current
Tester
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5.6.2
Cord-connected, normally
grounded apparatus
5.6.2.1
Using the test circuit of Figure 7
(see next page), the earth risk
current shall be measured in the
protective power ground (earth).
5.6.2.2
Measurement shall be performed
when:
a) the utility electrical supply is
normal/when the utility
electrical supply is reversed (by
reversing S1). These are normal
conditions;
1:1
Rated
Line
+10%
Apparatus
Under
Test
120V
60Hz
Select Per
5.5
120K
Ground
Risk Current
Tester
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Electrical
Safety
Made Easy
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I(mA rms) =
Apparatus
Under
Test
Protective
Earth
(Ground
Conductor)
Risk
Current
Tester
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10
101
102
103
104
105
A.1 General
The rationale discusses the need
for the standard and describes the
basic underlying principles,
empirical data, assumptions, and
sources that support the
requirements and test methods
adopted in the standard.
A.2 Need for the standard
This standard seeks to reduce the
risk of inadvertent electric shock
from medical devices. In
particular, it concerns itself with
the risk of injury from the small
currents that inevitably flow from
or to electromedical apparatus.
The intent of the AAMI Electrical
Safety Committee was to develop a
general baseline standard. The
extent to which the standard
should be applied is to be
determined by individual
institutions, standards groups, and
other authorities.
A.3 Classification of
electromedical apparatus and
measurement conditions
Changes from the second edition of
the standard (AAMI, 1985) have
been made in keeping with
changes to the requirements given
in Section 4.
A.4 Rationale for the specific
provisions of the standard
A.4.1 Labeling and
documentation requirements
A.4.1.1 Isolated patient
connection (labeling)
Fault conditions can contribute to
patient risk due to source and sink
currents. The greatest risk is with
direct cardiac applications; such
applications should utilize isolated
patient connections. In order to
better manage patients requiring
direct cardiac connection, the user
should be able to readily identify
electromedical apparatus with
isolated patient connections.
Therefore, labels should appear on
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Safety
Made Easy
IV.
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Electrical
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Made Easy
IV.
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disturbance in rhythm in
humans was 80 mA. In a
second study, Watson
(1973) found that the
smallest current that produced ventricular fibrillation in humans was
15 mA.
4) Mechanically induced
ventricular fibrillation has
been observed during
cardiac catheterization at
zero current.
5) The human data obtained
by Starmer (1973) and
Watson (1973) follow,
reasonably well, a normal
distribution for currents to
300 mA. All patients are
not equally susceptible to
current-induced ventricular
fibrillation. According to
Figure A.1, there is approximately a 1 percent probability of fibrillation at
30 mA.
6) Current perception is a
function of contact
location, contact pressure,
skin condition, moisture,
and contact area. Experiments report a wide range
of current perception.
Dalziel (1968) reports that
only approximately 1 percent of the population can
perceive 500 mA passing
from the fingers of one
hand to the fingers of the
other hand. Tan and
Johnson (1990) report that
300 mA produces a strong
sensation for electrodes
placed 10 cm apart on the
upper arm. Levin (1991)
reports that nearly all the
population will perceive
500 mA without any reaction for current passing
from the finger on one
hand to the underside of
the wrist on the other hand.
Levin further reports that,
on the underside of the
wrist, the stratum corneum
(layer of dead material on
the skin surface) is not as
thick as that on the forefinger and, therefore, the
sensitivity to current
perception might be higher.
Startle current is that level
of perception current that,
when first perceived, might
result in a nurse or other
clinician's involuntary
reaction to the sudden
sensation of perception
current. This uncontrolled
reaction is of great concern.
7) Worldwide, since the
advent of risk current
standards, concern about
grounding, and use of
better practices in handling
catheters and invasive
cardiac connections, there
have been no reports of
incidents involving risk
current passing through
the patient.
NOTE A minority of the AAMI
Electrical Safety Committee were
opposed to increasing risk current
limits unless scientific studies
supported higher limits.
Also, in order to harmonize with
IEC 601-1 and to allow for
additional fault conditions as
compared to the current standard,
the test measurement classifications of "normal condition" (NC)
and "single fault condition" (SFC)
were introduced.
Measuring risk current under SFC
is important because:
components can fail;
single faults exist that are not
now considered in the
standard;
faults can occur in accessory
equipment.
A.4.2.1 Apparatus interconnection
The total risk current associated
with a device can be a function of
the modules, accessories, and
interconnections used with the
device. Voltage differences can
occur between different parts of a
device, particularly if current flows
in the grounding circuit. Thus, a
remote accessory powered from the
device or from a separate source is,
for purposes of the standard,
considered part of the device.
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Electrical
Safety
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Starmer 60 Hz D = 1.25mm
Watson 60 Hz D = 2.0mm
99.9
99
Cumulative Percent
95
+
+
90
50
+
+
+
20
+
+
+
+
5
1
0.1
0
50
Electrical
Safety
Made Easy
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Electrical
Safety
Made Easy
IV.
Bibliography
-32-
Glossary
Of Terms
AMPACITY: Current-carrying capacity of electrical
conductors expressed in amperes.
CRITICAL EQUIPMENT:
Equipment that is
essential to the safety of the occupants in the facility.
DOUBLE-INSULATED APPLIANCES:
Appliances having an insulation system comprising both
basic insulation necessary for the functioning of the
appliance and for basic protection against electrical
shock and supplementary insulation. The supplementary
insulation is independent insulation provided in addition
to the basic insulation to ensure protection against
electric shock in case of failure to the basic insulation.
Millivolt.
mA:
Milliampere.
PATIENT-CARE-RELATED ELECTRICAL
APPLIANCE: An electrical appliance that is intended
to be used for diagnostic, therapeutic, or monitoring
purposes in a patient care area.
1-800-419-4000 www.bapcoinfo.com