Coltene BioSonic US100R, Owner'S Manual

Page: 12 / 136

12 BioSonic
®
Ultrasonic Scaler
5.3 EN/IEC 60601 - 1 -2:Ed 4.0 (2014-03) Sub-clause 5.2.2.2 Table 4
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
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 IEC60601 test level Compliance Level Intended Electromagnetic Environment
Conducted RF
IEC 61000-4-6 Ed 2.0
(A1:2004, A2:2006)
Radiated RF
IEC 61000-4-3
(Ed 3.0)
(A1: 2007)
(A2:2010)
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.7 GHz
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.7 GHz
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 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 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:
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
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 ® US100R unit is used exceeds the applicable RF compliance level above, the Biosonic ® US100R unit
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 ® US100R unit.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.