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Emissions test
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Electromagnetic immunity
The medical device is intended for use in an electromagnetic envi-
ronment as specified below. The user must ensure that the medi-
cal device is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transients/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
16
Compliance
Group 1
Class A
Not applicable
Not applicable
IEC 60601 test level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
3 A/m
<5% U
T
(>95% dip in U
) for 0.5 cycles
T
40% U
T
(60% dip in U
) for 0.5 cycles
T
70% U
T
(30% dip in U
) for 25 cycles
T
<5% U
T
(>95% dip in U
) for 5 s
T
Electromagnetic environment - guidance
The medical device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
The medical device is suitable for use in all establishments other
than domestic, and may be used in domestic establishments and
those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes, pro-
vided the following warning is heeded:
Warning: This equipment/system is intended for use by
healthcare professionals only. This equipment/system may
cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation
measures, such as re-orienting or relocating the medical
device or shielding the location.
Compliance level
Electromagnetic environment - guidance
±6 kV
Floors should be wood, concrete, or ceramic
tile. If floors are covered with synthetic
±8 kV
material, the relative humidity should be at
least 30%.
±2 kV
Mains power quality should be that of a typ-
ical commercial or hospital environment.
±1 kV
±1 kV
Mains power quality should be that of a typ-
ical commercial or hospital environment.
±2 kV
3 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location in
a typical commercial or hospital environ-
ment.
>95%, 0.5 cycles
Mains power quality should be that of a typ-
ical commercial or hospital environment. If
the user of the medical device requires con-
60%, 5 cycles
tinued operation during power mains inter-
ruptions, it is recommended that the medical
30%, 25 cycles
device is powered from an uninterruptible
power supply or a battery.
>95%, 5 s
Supplement Scio Four modules
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