Electromagnetic Compatibility
EN
64
11.3
Guidance and Manufacturer's Declaration - Electromagnetic Im-
munity
The Flow 50 is intended for use in the electromagnetic environment as described
below. The user/operator of the insufflator should make sure the device is oper-
ated within such an environment.
IMMUNITY tests
IEC 60601
Test level
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to
80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to
2.7 GHz
80% AM by
1 KHz
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propa-
gation is affected by absorption and reflection from structures, objects and peo-
ple.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast 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 the insufflator is used exceeds the applicable RF compliance
level above, the insufflator should be observed to verify normal operation. If ab-
normal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the insufflator.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.
Compliance
Electromagnetic environment -
level
guidance
Portable and mobile RF communi-
cations equipment should be
used no closer to any part of the
insufflator, including cables, than
the recommended separation dis-
tance calculated from the equa-
tion applicable to the frequency
of the transmitter. Recommended
safety distance:
3 V
Recommended separation dis-
tance
d = 1.2P for 150 KHz to 80 MHz
d = 1.2P for 80 MHz to 800 MHz
d = 2.3 P for 800 MHz to 2,7 GHz
3 V/m
where P is the maximum output
power rating of the transmitter in
watts (W) according to the trans-
mitter manufacturer and d is the
recommended separation dis-
tance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey
should be less than the compli-
ance level in each frequency
b
range.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
a