Coltene BioSonic US100R Guide D'utilisation page 11

Owner's Guide
5.3 EN/IEC 60601 - 1 -2:2007 Sub-clause 5.2.2.2 Table 4
The Biosonic ® US100R unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the
Biosonic ® US100R unit should assure it is used in such an environment.
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
objects, structures and people.
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 electromagnetic site survey should be considered. If the measured field strength in the
location in which the Biosonic
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the Biosonic
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
IEC60601 test level
3Vrms
150kHz to 80MHz
3V/m
80MHz to 2.5GHz
US100R unit is used exceeds the applicable RF compliance level above, the Biosonic
®
US100R unit.
®
Compliance Level
3Vrms
150kHz to 80MHz
3V/m
80MHz to 2.5GHz
Intended Electromagnetic Environment
Portable and mobile RF communications equip-
ment should be used no closer to any part of the
Biosonic US100R unit, including cables, than
®
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P 80MHz to 800 MHz
d = 2.3√P 800MHz to 2.5GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom-
mended minimum separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a,
should be less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of equip-
ment marked with the following symbol:
11
US100R unit
®