AITECS 2016 Universal Gebrauchsanleitung Seite 65

Table 3 Guidance and manufacturer's declaration - electromagnetic immunity - for
LIFE-SUPPORTING EQUIPMENT and SYSTEMS
Syringepump is intended for use in the electromagnetic environment specified below. The customer or
the user of Spritze pump should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Conducted RF 3 Vrms
150 KHz TO 80
IEC 61000-4-6 MHz outside ISM
a
bands
10 Vrms
150 kHz to 80 MHz
in ISM bands
Radiated RF 10 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80
MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could
cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is
used in calculating the recommended separation distance for transmitters in these frequency ranges.
Compliance
level
3 Vrms
10 Vrms
b
10 V/m
AITECS 2016
GEBRAUCHSANLEITUNG
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should
be used no closer to any part of syringepump, including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d=1.17√P
d=1.2√P
d=1.2√P 80 MHz to 800 MHz
d=2.3√P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
b
distance in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey,
compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked
with the following symbol:
c
should be less than the
d
65