USER MANUAL 16-2045
Rev. 09/2017
Page 22 of 25
12-3
Manufacturer’s guide and declaration – electromagnetic safety
This insufflator was designed to be used in the electromagnetic environment specified below. The
user must ensure that it is in fact used in this environment.
Safety test
IEC
60601
level of
gravity
Compliance
level
electromagnetic environment - guide
RF
conducted
EN 61000-4-
6
RF emitted
EN 61000-
4-3
3 Vrms
150 khz at 80
Mhz
3 V/m
80 Mhz at
2.5 ghz
3V 3V/m
Portable and mobile RF communication devices
–
cables included - must not be used at a distance nearer
than what is recommended. This distance is calculated
by applying the formula corresponding to the transmitter
frequency.
Recommended
separation distance d =
1,16 √ P d = 1,16 √ P
80 Mhz to 800 Mhz d =
2,33 √ P 800 Mhz to 2.5
ghz
Where
is the maximum output power from the
transmitter, in Watts (W), assigned by the manufacturer
of the transmitter and (d) is the recommended
separation distance in metres (m).
The field strengths emitted by fixed RF transmitters
–
which must be established by in situ electromagnetic
measurements
– must be lower than the compliance
strength in each frequency band.
interference may be caused by devices on which the
following symbol is displayed
:
Note 1: at 80 Mhz and 800 Mhz, it is advisable to use the highest frequency band.
Note 2: these recommendation may not be applicable in all situations. The propagation of
electromagnetic waves is modified by absorption and reflection due to structures, objects and people.
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