22
eNgLIsh
Guidance and manufacturer’s declaration – Immunity Emissions
The surgical aspirator TOBI HOSPITAL is intended for use in the electromagnetic environment specified below. The
customers or the user of the surgical aspirator TOBI HOSPITAL should assure that it’s used in such an environment.
Immunity Test
Level indicated by
the EN 60601-1-2
Livello di
conformità
Electromagnetic environments - guidance
Conducted
Immunity
EN 61000-4-6
Radiated
Immunity
EN 61000-4-3
3Vrms 150kHz to
80Mhz (for non life-
supporting devices)
3V/m 80MHz to
2.5GHz (for non life-
supporting devices)
V1 = 3 V rms
E1 = 3 V / m
The portable and mobile RF communication devices,
including cables, must not be used closer to the
TOBI HOSPITAL device, than the separation dis-
tance calculated by the equation applicable to the
transmitter frequency.
Recommended separation distance
3,5
V
1
√P
d
=
12
E
1
√P
d=
from 80MHz to 800MHz
23
E
1
√P
d=
from 800MHz to 2,5GHz
Where P is the maximum output power rating of the
transmitter in Watt (W) according to the transmitter
manufacturer and is the recommended separation
distance in metres (m). Field strengths from fixed RF
transmitters, as determined by an electromagnetic
site study of the site, should be less that the com-
pliance level in each frequency range. Interference
may occur in the vicinity of equipment
marked with the following symbol:
Note 1:
At 80 MHz and 800 MHz the interval with the highest frequency is applied.
Note 2:
These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by
the absorption and by reflection from buildings, objects and people.
a) The field intensity for fixed transmitters such as the base stations for radiotelephones (mobile and cordless) and
terrestrial mobile radio, amateur radio devices, radio AM and FM transmitters and TV transmitters can not be theor-
etically and accurately foreseen. To establish an electro-magnetic environment generated by fixed RF transmitters,
an electro-magnetic study of the site should be considered. If the field intensity measured in the place where the
device will be used surpasses the above mentioned applicable level of conformity, the normal functioning of the
device should be monitored. If abnormal performance arises, additional measures such as changing the device’s
direction or positioning may be necessary.
b) The field intensity on an interval frequency of 150 kHz to 80 MHz should be less than 3 V/m.
