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16 Supplement Scio Four modules
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 IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±6 kV contact ±6 kV Floors should be wood, concrete, or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
±8 kV air ±8 kV
Electrical fast transients/burst
IEC 61000-4-4
±2 kV for power supply lines ±2 kV Mains power quality should be that of a typ-
ical commercial or hospital environment.
±1 kV for input/output lines ±1 kV
Surge
IEC 61000-4-5
±1 kV line(s) to line(s) ±1 kV Mains power quality should be that of a typ-
ical commercial or hospital environment.
±2 kV line(s) to earth ±2 kV
Power frequency (50/60 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 environ-
ment.
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
<5 % U
T
(>95 % dip in UT) for 0.5 cycles
>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-
tinued operation during power mains inter-
ruptions, it is recommended that the medical
device is powered from an uninterruptible
power supply or a battery.
40 % U
T
(60 % dip in UT) for 0.5 cycles
60 %, 5 cycles
70 % U
T
(30 % dip in UT) for 25 cycles
30 %, 25 cycles
<5 % U
T
(>95 % dip in UT) for 5 s
>95%, 5s
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
10 V/m
80 MHz to 2.5 GHz
3V
3V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the medical device, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum output power rat-
ing 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
1)
,should be less than the compliance
level in each frequency range.
2)
Interference may occur in the vicinity of
equipment marked with the following sym-
bol:
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