Electrical Safety

in Medical Equipment

© D. J. McMahon 141008 rev cewood 2017-10-23

Key Points
Electrical Safety in Medical Equipment:

- know the significance of NFPA-99 and the annual editions

- define 'the patient care vicinity' (PCV)
- know about the 'wet location' and LI vs GFCI
- know the definitions AND SYMBOLS for applied parts B, BF, CF
- recognize the symbols for 'defibrillation proof'
- know the methods for electrical signal isolation & power isolation
- be able to define leakage current; what contributes to it?
- recognize the electrical safety standards and know which one is commonly used in the US
- MEMORIZE the 2015 NFPA-99 standards; 3 values, including the units
- do these values apply to non patient care devices?
- know the easy fix for high leakage, often built-in to devices
- when do we do electrical safety testing?
- understand the problem of finding an actual chassis ground point
- how do these standards apply to two-prong plug devices?
- know about testing 'systems'
- know about Line Isolation & LIMs
- are extension cords and power strips allowed? what are the requirements?
 Birth of the HTM Profession :
(March 1971)

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.

- Clinical Engineering is responsible for all patient-impact equipment

that is within the Patient Care Vicinity. Any equipment in that area must
meet NRTL or NFPA-99 electrical safety standards.

- Equipment in non-patient care areas (nurses stations, lounges, etc)

does not need to meet those standards but may be checked by Facilities
Engineering or Clinical Engineering, depending on hospital policy.
The “Patient Care Vicinity”
(the ‘bubble’)
Patient Care Vicinity: a crowded place!
 “Wet Location”

“The area in a patient care area where a procedure is performed

that is normally subject to wet conditions while patients are
present, including standing fluids on the floor or drenching of the
work area, either if which is intimate to the patient or staff.”
- NFPA-99 (2005) 3.3.185

> typically applies to surgical suites and other areas

> controversial topic lately –
- architects tending away from Line Isolation in O.R.s
- GFCI’s being used instead
 “Applied Part” of medical equipment
as defined by the IEC standard 60601-1:

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

If ‘Defib Proof’, ONE of these

see the little defib paddles?
IEC Definitions:

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.

Electrical safety is all about current path to ground.

How to electrocute homo sapiens…
(through skin) (under skin)
I = 120V / 100KW I = 120V / 25KW
= 1.2 mA = 4.8 mA
= 1200 µA = 4800 µA
Ungrounded (2-wire) wiring
Grounded (3-wire) wiring
Chassis Ground (at power entry)
Electrical Isolation: transformer isolation for power

opto-isolator for electrical signal:

 Leakage current:

or “distributed capacitance”

Leakage current is both capacitive, caused by intrinsic

capacitance between conductors;
and resistive, caused by imperfect insulation.
RF filters at power entries will add to capacitive leakage:
Where does the leakage current go?
Open ground !
Where does the leakage current go now?
Fatality by microshock scenario:
 Electrical Safety Testing Terminology
NEMA / AAMI (US): IEC (international):
Hot - - - - L1
Neutral - - - L2
Ground - - - Earth
Line Voltage - - - Mains
Patient Contacts (leads, paddles) Applied Parts
Chassis - - - Enclosure
Ground Wire - - - Protective Earth (PE)
Leakage Current in Ground Wire Earth Leakage Current
Chassis leakage - - Enclosure Leakage
Lead leakage - - - Patient Leakage
Leakage between Patient Leads Patient Auxiliary
Lead Isolation - - - Mains on Applied Parts (MAP)
Ground Wire Resistance - Earth Resistance
Insulation Resistance between Insulation Resistance
Hot and Neutral to Ground
What are the electrical safety standards ?
AAMI ES-1 (same as NFPA99)
- most commonly used in the U.S.

IEC 60601-1 (same as UL2601-1 in the U.S.

CSA C22.2 in Canada)
- most widely used, but written for manufacturers

IEC 62353
- written for end-users; a bit looser requirements

AN/NZS 3551 (modified 60601-1)

The NFPA-99 Electrical Safety Test:
1) ground integrity
2) chassis leakage
3) patient contact lead-to-ground leakages
4) patient contact lead-to-lead leakages
5) patient contact lead leakage while in
contact with the line voltage (MAP)

Know your analyzer !!

 NFPA99 Chassis Leakage
(touch) Current
• 1999 edition
• 2005 edition

• 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!

standard has changed!

 Electrical Safety Testing Values

(per NFPA-99, 2012 edition)

Resistance of Ground wire of power cord: 500 milliOhms

(500m or .5 )

Leakage current at the chassis: NC (normal condition) 100 microAmps

(100 A)

SFC (Single Fault Condition, e.g. open ground) 500 microAmps

(500 A)

Leakage current for any one patient contact lead to ground:

10 A with ground closed, 50 A with ground open.

Leakage current for each patient contact lead to any other lead:
10 A with ground closed, 50 A with ground open.

Leakage current for patient leads exposed to line voltage: 50 A

 Standard circuit described in NFPA 99
for measurement of leakage current:

“Applied Part” = any component of a device that

is directly applied to the patient.
(Electrodes, paddles, sensors, etc)
 Test device measuring
chassis leakage current:

note: no switch to open neutral leg;

grounding switch shown in SFC
(single fault condition)
 Test device measuring
patient lead leakage current:

(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)

e.g. a vacuum cleaner

 Non-Medical Grade equipment -
esp Medical computers, TV’s, etc…

- can have high leakage current due to capacitance in line filters

- corrective action for these if used in patient care areas:

- connect a redundant ground wire, or

- go thru an isolation transformer in the power input

 What about plastic-enclosed,
(sometimes battery-driven) medical devices?

Many medical devices have no electrically conductive

surfaces to access as the “enclosure” for the purposes of
connecting a test device to check leakage or ground integrity.

NFPA-99 has a specific way to establish a temporary

reference point using a 10x10 cm sheet of foil, but it is not
very practical.

You will often need to find any possible metallic point

that is continuous with the device’s ground.

In some cases, the device simply can’t be checked for

leakage.
e.g. an irrigation pump used in surgery:
 When to we do Electrical Safety Testing?

1) on any incoming inspection of new equipment,

including rented, borrowed, or donated equipment

2) after any repair or modification

3) as part of scheduled Performance Verifications

(depending on department policy)

- may also be useful as part of troubleshooting

Typical Electrical Safety Analyzers
 In the NSCC Lab:

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.

e.g.: imaging systems, treadmills, large centrifuges.

‘Point-to-Point’ testing for leakage current and

resistance is done with ES analyzers on equipment
that is fixed. Acceptable leakage limits are higher.
Standard power distribution grounding:
Isolated power branch (“Line Isolation”):
Isolated Power System -
Generally used in Operating Rooms
Line Isolation Monitor (LIM)
LIM’s alternately look at each side of the line to
check for excessive leakage relative to ground:
Circuit Breaker Panel
Line isolation
transformer

Line isolation
monitor
(LIM)
Typical setting and reading for a LIM
Extension Cords:
Generally allowed for use in the patient care
vicinity, IF:

> They use wire that exceeds current capacity

of the power outlet being extended.
(usually 14 gauge or 12 gauge, + ground)

> Designed with medical-grade components.

‘Multioutlet Extension Cords’
‘Multiple Outlet Strips’
‘Power Strips’
‘Relocatable Power Taps’
Standardized in UL #1363.
Allowed by NFPA 99, IF:
- they are made of medical grade components
- they are of adequate ampacity for the need
- they are inventoried and maintained
Not Hospital Grade

Hospital Grade
Relocatable Power Taps
are now acceptable IF:

-- Are permanently attached to equipment.

-- The total current drawn is <75% of the cord.
-- The cord complies with NFPA 70.
-- The power tap is checked as part of PM’s.
-- Added devices aren’t attached to exceed
the allowed leakage current.

(CMS Waiver, Sept 25, 2014)

 Relocatable Power Taps -
keep ‘em short!

Good practice to keep Relocatable Power Taps short

• Longer ground wire increases ground wire resistance

• Longer hot & neutral wires add voltage drop
• Longer power cables add clutter to the room
• Longer power cables increase tripping hazard
 PowerMate

PowerBall
 2-prong to 3-prong adapters or ‘Cheaters’:

Not a safe solution to the ungrounded receptacle,

and NOT ALLOWED in healthcare facilities.

(These assume that the electrical box on the wall is a good,

reliable ground point, tied to earth ground through metal conduit.
Even though the building wiring is not grounded?
Not a good bet anywhere!)
Surge protection power strips:
NOT for medical devices !
AC/DC adapters (plug-in power supplies)

Inspect routinely, and replace as needed

Plug-in power supplies
- Allow manufacturers to internationalize easily.
- Requirements for meeting NRTL certification of the product is reduced
by isolating the line-level circuitry.
- Lets the power supply manufacturer deal with the expense and liability of
certification.
- Makes repair by the customer possible.

Choosing (or replacing) a plug-in supply "only" requires

attention to these details:
- input voltage and frequency (your national standard)
- input connector (NEMA, IEC, or 17 other national standard plugs)
- output voltage
- output current (maximum available)
- whether the output is DC or AC
- for DC, whether the supply is:
linear un-regulated (must match load)
linear regulated
switching
- if the power supply will fit physically where it needs to go

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 ( )