Electromagnetic Compatibility
43
EN
11.3
Guidelines and Manufacturer's Statement - Electromagnetic In-
terference Immunity
The insufflator AirSeal® iFS is intended for use in an electromagnetic environ-
ment as described below. The user/operator of the insufflator should make sure
the device is operated within such an environment.
*Note: U
T
is the mains alternating voltage before applying the test levels.
Electromagnetic interfer-
ence immunity tests
IEC 60601 test level
Compliance Levels
Electromagnetic environment guidelines
Electrostatic discharges
(ESD) IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be made from wood or con-
crete or covered with ceramic tiles. If the
floor covering consists of synthetic material,
the relative humidity should be at least 30%.
Electrical fast transients/
bursts according to
IEC 61000-4-4
± 2 kV for power lines
± 1 kV for input and out-
put lines
Modulation 100 KHz
± 2 kV for power lines
± 1 kV for input and
output lines
Modulation 100 KHz
The quality of the supply voltage should be
the same as the voltage of a typical business
or hospital environment.
Surges according to IEC
61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
The quality of the supply voltage should be
the same as the voltage of a typical business
or hospital environment.
Blackouts, brownouts,
and fluctuations of the
power supply according
to IEC 61000-4-11
0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°,270° and 315°
0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°,270° and
315°
The quality of the supply voltage should be
the same as the voltage of a typical business
or hospital environment. If the user/opera-
tor of the device requires continuation of
functionality after power interruptions/dis-
ruptions, it is recommended to supply the
device with power from an uninterruptible
power supply or battery.
0 % UT; 1 cycle and 70 %
UT; 25/30 cycles Single
phase : at 0°
0 % UT; 1 cycle and
70 % UT; 25/30 cycles
Single phase : at 0°
0 % UT; 250/300 cycles
0 % UT; 250/300 cycles
Supply frequency (50/60
Hz) magnetic field IEC
61000-4-8
30 A/m
30 A/m
Magnetic fields of the mains power fre-
quency should comply with the typical val-
ues of business and hospital environments.
Portable and mobile wireless devices should
not be used in closer proximity to the 40L
High Flow Insufflator (including cables/lines)
than the recommended safety distance cal-
culated based on the transmitting frequency
and the applicable formula. Recommended
safety distances:
Conducted RF IEC 61000-
4-6
3 Vrms 150 kHz to
80 MHz
3 V
Recommended safety distances
d = 1.2
P for 150 KHz to 80 MHz
d = 1.2
P for 80 MHz to 800 MHz
d = 2.3
P for 800 MHz to 2.7 GHz
Transients RF IEC 61000-
4-3
3 V/m 80 MHz to 2.7 GHz
80% AM by 1 KHz
3 V/m
where
P
is the max. rated output of the
transmitter in watt (W) according to the
information provided by the manufacturer
of the transmitter.
d
is the recommended
separation distance in meters (m).
The field strength of stationary transmitters
for all frequencies tested on site
a
should be
lower than the concordance level.
b
Interference is possible in the proximity of
devices featuring the following pictograph.
Содержание AirSeal iFS
Страница 1: ...EN Instructions for use...
Страница 4: ......
Страница 6: ...2 EN 15 AirSeal iFS Warranty 52 16 Test Log 53 16 1 Test Log 53 16 2 Return Form 54 Index 55...
Страница 20: ...16 Initial Device Startup EN House gas supply pressure OK House gas supply pressure too low...
Страница 57: ...Test Log 53 EN 16 Test Log 16 1 Test Log Date Results Comment Signature...
Страница 60: ...W55 186 EN AA...