Guidelines And Manufacturer's Statement - Electromagnetic Interference Immunity - For The Insufflator - Arthrex Synergy Insufflation FM134 Instructions D'utilisation

12.6 Guidelines and Manufacturer's Statement - Electromagnetic In-
terference Immunity - for the Insufflator
Electromagnetic Test level
interference
immunity tests
Conducted HF 3 Veff
interference 150 kHz to
quantities 80 MHz
according to IEC
61000-4-6
3 V/m
Radiated HF
80 MHz to
interference
2.5 GHz
quantities
according to IEC
61000-4-3
Note 1: The higher frequency range applies for 80 and 800 MHz.
Note 2: These guidelines are probably not realizable in all cases. The distribution
and spread of electromagnetic quantities differs depending on the absorption
and reflection of buildings, objects, and people.
a
The field strength of stationary transmitters such as base stations of wireless
phones and cell phones, ham radio operators, AM and FM radio and TV stations
can theoretically not always determined in advance. A study of the installation
site should be considered to determine the electromagnetic environment con-
cerning the stationary transmitter. If the field strength measured at the usage
site of the insufflator exceeds the compliance levels listed above, the insufflator
should be monitored for proper function. If unusual performance characteristics
are observed, additional measures may be required such as changing orientation
or the location of the insufflator.
b
The field strength should be less than 3 V/m for the frequency range of 150 kHz
to 80 MHz.
Compliance Electromagnetic environ-
ment guidelines
In compliance Portable and mobile wire-
less devices should not be
used in closer proximity to
the Insufflator (including
cables/lines) than the rec-
ommended safety distance
calculated based on the
transmitting frequency and
the applicable formula. Rec-
ommended safety dis-
tance: 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
2,5 GHz
With P as the rated output
of the transmitter in watts
[W] according to the infor-
mation provided by the
manufacturer of the trans-
mitter and d as recom-
mended safety distance in
meters [m].
The field strength of sta-
tionary transmitters for all
frequencies tested on site
should be lower than the
concordance level.
Interference is possible in
the proximity of devices
featuring the following pic-
tograph.
a
b
Electromagnetic Compatibility
57
EN