Document #82070-646, Revision C
CONFIDENTIAL
©2010 VTS Medical Systems, LLC
Page 39 of 40
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Electrical fast transient/
burst IEC 61000-4-4
±2 kV for power supply
lines ±1 kV for
input/output lines
±2 kV for power supply
lines ±1 kV for
input/output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5
±1 kV line(s) to line(s) ±2
kV line(s) to earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
UT = 230 Vac
<5 % UT (>95 % dip in
UT) for 0,5 cycle 40 % UT
(60 % dip in UT) for 5
cycles 70 % UT (30 % dip
in UT) for 25 cycles <5 %
UT (>95 % dip in UT) for
5 sec
<5 % UT (>95 % dip in
UT) for 0,5 cycle 40 %
UT (60 % dip in UT) for
5 cycles 70 % UT (30 %
dip in UT) for 25 cycles
No anomalies 95% dip
meets requirements.
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the equipment requires continued operation
during power mains interruptions, it is
recommended that the equipment be powered
from an uninterruptible power supply or a battery.
Power frequency (50
Hz) magnetic field IEC
61000- 4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Conducted RF IEC
61000- 4-6 Radiated
RF IEC 61000-4-3
3 Vrms 150 kHz to 80
MHz 3 V/m 80 MHz to 2,5
GHz
3 V 3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part of
the equipment including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter. Recommended separation
distance
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
should be less than the compliance level in each
frequency range Interference may occur in the
vicinity of known RF transmitting devices and
equipment marked with the following symbol:
Note 1
: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2
: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the equipment
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
