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TABLE 2:
Guidance and manufacturer's declaration – electromagnetic IMMUNITY
The customer or the user of these electrical stimulators should assure that it is used in such
environment.
Immunity test
IEC 60601 test level Compliance level Electromagnetic
Electrostatic
±6 kV contact
discharge (ESD)
±8 kV air
lEC 61000-4-2
±2 kV for power
Electrical fast
supply lines
transient/burst
±1 kV for input/
IEC 61000-4-4
output lines
± 1 kV line(s) to
Surge
line(s)
IEC 61000-4-5
± 2 kV line(s) to
earth
Voltage dips, short
<5% U
T
interruptions and voltage
(>95% dip in U
variations on power supply
for 0.5 cycle
input lines IEC 61000-4-11
40% U
T
(60% dip in U
for 5 cycles
70% U
T
(30% dip in U
for 25 cycles
<5% U
T
(>95% dip in U
for 5 sec
3 A/m
Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
25
environment - guidance
Floors should be wood,
±6 kV contact
concrete or ceramic tile.
±8 kV air
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Mains power quality
±2kV for power
should be that of a
supply lines
typical commercial or
hospital environment.
Mains power quality
±1 kV differential
should be that of a
mode
typical commercial or
hospital environment.
<5% U
Mains power quality
T
)
(>95% dip in U
)
should be that of a
T
T
for 0.5 cycle
typical commercial or
hospital environment.
40% U
If the user of the DEVICE
T
)
(60% dip in U
)
requires continued
T
T
for 5 cycles
operation during power
mains interruptions, it
70% U
is recommended that
T
)
(30% dip in U
)
the DEVICE be powered
T
T
for 25 cycles
from an uninterruptible
power supply or a
<5% U
battery.
T
)
(>95% dip in U
)
T
T
for 5 sec
Power frequency
3 A/m
magnetic fields should
be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
TABLE 4:
Guidance and manufacturer's declaration – electromagnetic IMMUNITY
The customer or the user of these electrical stimulators should assure that it is used in such
environment.
Immunity test IEC 60601 test level Compliance level
Conducted RF
3 Vrms
3 Vrms
lEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
3 V/m
lEC 61000-4-3
80 MHz to 2.5 GHz
NOTE I At 80 MHz ends 800 MHz the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
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 device is used
exceeds the applicable RF compliance level above, should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the device.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Electromagnetic
environment - guidance
Portable and mobile RF
Communications equipment should
be used no closer to anypart of the
device, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance
d = 1.2
d = 1.2
80 MHz to 800 MHz
d = 2.3
800 MHz to 2.5 GHz
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).
F
transmitters, as determined by an
electromagnetic site survey,
a
should
be less than the compliance level in
each frequency range.
b
Interference may occur in the
vicinity of equipment marked
with the following
symbol:
26
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