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Table 202 - Guidance and manufacturer's declaration - electromagnetic immunity
Immunity test
IEC 60601 test level
Electrostatic discharge (ESD)
±6 kV contact
IEC 61000-4-2
±8 kV air
Electrical fast transient/burst
±2 kV for power supply lines ±1 kV
IEC 61000-4-4
for input/output lines
Surge IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
Voltage dips, short interrup-
<5% U
(>95% dip in U
) for 0.5 cycle
T
T
tions and voltage variations
40% U
(60% dip in U
) for 5 cycles
T
T
on power supply input lines
70% U
(30% dip in U
) for 25 cycles
T
T
IEC 61000-4-11
<5% U
(>95% dip in U
) for 5 sec
T
T
Power frequency (50/60 Hz)
3 A/m
magnetic field IEC 61000-4-8
NOTE U
is the a.c. mains voltage prior to application of the test level.
T
GB-58
Appendix
Compliance level
Electromagnetic environment - guidance
±6 kV contact
Floors should be wood, concrete or ceramic tile.
±8 kV air
If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
±2 kV for power supply lines ±1 kV
Mains power quality should be that of a typical
for input/output lines
commercial or hospital environment.
±1 kV differential mode
Mains power quality should be that of a typical
±2 kV common mode
commercial or hospital environment.
<5% U
(>95% dip in U
) for 0.5 cycle
Mains power quality should be that of a typical
T
T
commercial or hospital environment.
40% U
(60% dip in U
) for 5 cycles
T
T
If the user of
visocor OM40 requires continued
70% U
(30% dip in U
) for 25 cycles
®
T
T
operation during power mains interruptions,
<5% U
(>95% dip in U
) for 5 sec
T
T
it is recommended that
visocor OM40 be
®
powered from an uninterruptible power supply
or a battery.
0.3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Appendix
Table 204 - Guidance and manufacturer's declaration - electromagnetic immunity
Immunity
IEC 60601
Compliance
Electromagnetic environment - guidance
test
test level
level
Portable and mobile RF radio equipment should be used no closer to any part of
visocor OM40, including cables, than the recommended separation distance calculated from the equation
®
applicable to the frequency of the transmitter.
Recommended separation distance:
Conducted
3 Vrms 150
N/A
RF IEC
kHz to 80
61000-4-6
MHz
Radiated RF
3 V/m 80
3 V/m
d=1.2√P 80 MHz to 800 MHz
IEC 61000-
MHz to 2.5
d=1.2√P 800 MHz to 2.5 GHz
4-3
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 metres (m). Field strengths from fixed RF
transmitters, as determined by an electromagnetic site survey,
each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a
Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
stations and TV stations cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electro-
magnetic site survey should be considered. If the measured field strength in the location in which
level above,
visocor OM40 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
®
as reorienting or relocating
visocor OM40.
®
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
a
should be less than the compliance level in
b
visocor OM40 is used exceeds the applicable RF compliance
®
G
GB-59

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