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Sistem Pengaman Kelistrikan Medical Equipment PDF
Sistem Pengaman Kelistrikan Medical Equipment PDF
in Medical Equipment
http://kami.camp9.org/Resources/Pictures/Ralph-naders-most-shocking-expose[1].pdf
NFPA 70®: National Electrical Code® (NEC®)
Sets requirements for building design,
construction, operation, and
maintenance.
Applies to all buildings.
Adopted as code in 46 states, the VA
system, and the Centers for Medicare
and Medicaid Services (CMS).
National Electrical Code (NEC)
Section 517: Health Care Facilities
Discusses electrical service for hospitals and clinics
> General electrical distribution
> Power supply backups
> Defines emergency power distribution
> Specifies electrical concerns for specialty areas:
- anesthetizing locations
- isolated power systems and their monitors
- pediatric areas
- X-ray
NFPA 99
Sets criteria for health care
services based on risk to
the patients, staff, or
visitors in health care
facilities to minimize the
hazards of fire, explosion,
and electricity.
Includes installation,
inspection, testing, and
maintenance of facilities,
equipment, and appliances,
including medical gas and
vacuum systems.
The “Patient Care Vicinity”
Per NFPA 99:
A space within the location intended for patient care, extending 1.5 m
(~ 6 feet) beyond the normal location of the bed, table, etc that supports
the patient during examination or treatment, and extending vertically
2.5 m (~7.5 feet) above the floor.
Type B: Applied parts that are generally not conductive and can be
immediately released from the patient. May be grounded.
eg: Non-invasive BP monitors [think: Body]
Type BF: Devices that have direct contact with the patient, or parts that
have long term contact with the patient.
eg: ECG monitors [think: Body, Floating (ground)]
Type CF: Applied parts that have direct contact with the heart.
eg: Invasive pressure monitors, defib paddles
[think: Cardiac Floating (ground)]
ONE of these ratings should be present on a medical device
Class I Equipment –
Device is protected against shock by use of
a grounding wire connected to the exposed
conductive parts of the device.
Class II Equipment –
Device is protected by additional insulation in
addition to the basic design insulation.
Usually called “Double Insulated”.
Why aren’t these birds electrocuted ? …
… because they’re not grounded.
or “distributed capacitance”
IEC 62353
- written for end-users; a bit looser requirements
• 2012 edition
• 2015 edition
10.2.6* Touch Current – Portable Equipment. The touch current for cord-
connected equipment shall not exceed 500 A with normal polarity and the
ground wire disconnected (if a ground wire is provided).
still valid:
.5
1999 rev;
PRE-2012!
Leakage current for each patient contact lead to any other lead:
10 A with ground closed, 50 A with ground open.
(DUT)
Test device measuring
isolation current with MAP
(Mains on Applied Parts):
(DUT)
What about non-patient care devices?
For Non-Patient Care devices, within the PCV:
Leakage current at the chassis: 500 microAmps (0.5 mA)
e.g. a mobile computer terminal
the PCV
For Non-Patient Care devices,
not in the PCV:
Leakage current at the chassis:
3500 microAmps (3.5 mA)
Rigel SafeTest 50
Fluke ESA612
Dale 544D+
The resistance measurement problem:
One solution: Kelvin (4-wire) resistance leads
Kelvin Lead set on an electrical safety tester:
Chassis Ground Lug
(or POAG: Point of Actual Ground)
Grounding wire
POAG connector
Where do we find chassis ground?
What about testing multiple
medical devices (or ‘systems’) ?
“System”
in the context of medical equipment inventory, refers
to a number of medical devices commonly used
together, which share a common power strip.
Generally, the electrical safety check of a system can
be done at the common power cord that feeds it.
- be certain that the total current draw of the system,
when at maximum, does not exceed ~75% of the
power strip’s rating.
Example: typical medical video tower
What about “Fixed Equipment”?
i.e. equipment that is permanently installed to the
building structure.
Line isolation
monitor
(LIM)
Typical setting and reading for a LIM
Extension Cords:
Generally allowed for use in the patient care
vicinity, IF:
Hospital Grade
Relocatable Power Taps
are now acceptable IF:
PowerBall
2-prong to 3-prong adapters or ‘Cheaters’:
AND...
- the output connector!
Package insert with ECG wires, before 1985:
Any signal connector for patient contact,
(eg for ECG) must either be female, or
be must be protected by a shield so that
it cannot be connected to a source of
lethal voltage.
- change in ANSI design standards,
effective in 1987 after a fatal incident in early ‘80s
Female ( ) Recessed Male ( )