Coltene PerFect TCS II Manual De Usuario página 14

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1.3 EN/IEC 60601-1-2:2007 Sub-clause 5.2.2.2 Table 4:
The Perfect TCSII unit is intended for use in the electromagnetic environment specified below. The customer or the end user of the Perfect
®
TCSII unit should assure it is used in such an environment.
Immunity Test IEC60601 test level
Conducted RF 3Vrms
IEC 61000-4-6 150kHz to 80MHz
Radiated RF 3V/m
IEC 61000-4-3 80MHz to 2.5GHz
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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
a
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 Perfect ® TCSII unit is used exceeds the applicable RF compliance level above, the Perfect
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
Perfect TCSII unit.
®
Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
b
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
Compliance Level
3Vrms
150kHz to 80MHz
3V/m
80MHz to 2.5GHz
EN PerFect
Intended Electromagnetic Environment
Portable and mobile RF communications equipment should be used
no closer to any part of the Perfect
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
recommended minimum separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an elec-
tromagnetic site survey , should be less than the compliance level in
a
each frequency range. b
Interference may occur in the vicinity of equipment marked with the
following symbol:
® TCSII unit should be observed to verify
TCS II Tissue Contouring System
®
® TCSII unit, including cables,
®