Guidance And Manufacturer's Declaration-Electromagnetic Immunity - Ethicon Echelon Flex PCEE45A Manual Del Usuario

Guidance and manufacturer's declaration—electromagnetic immunity
The ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters are intended for use in the electromagnetic environment
specified below. The customer or the user of the ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters should ensure that
they are used in such an environment.
IMMUNITY test
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 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.
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 ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters are used exceeds the applicable RF compliance level above,
the ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the ECHELON FLEX™ Powered Plus
Articulating Endoscopic Linear Cutters
IEC 60601 TEST
LEVEL
Not applicable
3 V/m
Compliance
level
Portable and mobile RF communications
equipment should be used no closer to
any part of the Powered Plus Articulating
Endoscopic Linear Cutter, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
Not Applicable
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
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:
9
Electromagnetic environment –
guidance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
should be less than the
a