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ELECTROMAGNETIC COMPATIBILITY
The system is designed to be in compliance with IEC 60601‑1‑2:2007, which contains
electromagnetic compatibility (EMC) requirements for medical electrical equipment.
The limits for emissions and immunity specified in this standard are designed to provide
reasonable protection against harmful interference in a typical medical installation.
The system complies with the applicable essential performance requirements specified
in IEC 60601‑1 and IEC 60601‑2‑18. Results of immunity testing show that the essential
performance of the system is not affected under the test conditions described in the
following tables.
ELECTROMAGNETIC IMMUNITY
Table 10. Guidance and Manufacturer's Declaration —Electromagnetic Immunity
The system is intended for use in the electromagnetic environment specified below. The customer or the
user of the system should ensure that it is used in such an environment.
Immunity Tests
Electrostatic
± 6 kV contact
discharge (ESD)
± 8 kV air
IEC 61000‑4‑2
± 2 kV for power
Electrical fast
supply lines
transient/burst
± 1 kV for input/
IEC 61000‑4‑4
output lines
Surge
± 1 kV line(s) to line(s)
IEC 61000‑4‑5
± 2 kV line(s) to earth
<5% U
for 0.5 cycle
Voltage
dips, short
40% U
interruptions and
for 5 cycles
voltage variations
on power supply
70% U
input lines
for 25 cycles
IEC 61000‑4‑11
<5% U
for 5 s
Power frequency
(50/60 Hz)
3 A/m
magnetic field
IEC 61000‑4‑8
Conducted RF
3 Vrms
150 kHz to 80 MHz
IEC 61000‑4‑6
22
IEC 60601 Test Level
(>95% dip in U
)
t
t
(60% dip in U
)
t
t
(30% dip in U
)
t
t
(>95% dip in U
)
t
t
Compliance
Electromagnetic Environment –
Level
Floors should be wood, concrete,
or ceramic tile. If floors are covered
In compliance
with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that
In compliance
of a typical commercial or hospital
environment.
Mains power quality should be that
In compliance
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
system requires continued operation
In compliance
during power mains interruptions,
it is recommended that the system
be powered from an uninterruptible
power supply or a battery.
Power frequency magnetic fields
should be at levels characteristic
In compliance
of a typical location in a typical
commercial or hospital environment.
Portable and mobile RF
communications equipment should
be used no closer to any part of the
system, including cables, than the
recommended separation distance
calculated from the equation
3 V
applicable to the frequency of the
transmitter.
Recommended separation
distance d (m)
d=1.2 √P
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