Guidance And Manufacturer's Declaration-Electromagnetic Emissions; Guidance And Manufacturer's Declaration-Electromagnetic Immunity - Johnson & Johnson ECHELON FLEX + Manual De Instrucciones

Electromagnetic Emissions Guidance
Guidance and manufacturer's declaration—electromagnetic emissions
The ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter is intended for use in the electromagnetic environment
specified below. The customer or the user of the ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter should ensure
that it is used in such an environment.
Emissions test Compliance
Harmonic emissions
Not applicable
IEC 61000-3-2
The ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutter
is suitable for use in all establishments other than domestic and those directly
Voltage fluctuations/
connected to the public low-voltage power supply network that supplies buildings
flicker emissions
Not applicable
used for domestic purposes.
IEC 61000-3-3
RF emissions The ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear
Complies
CISPR 14-1 Cutter is not suitable for interconnection with other equipment.
Electromagnetic Immunity Guidance
For electromagnetic immunity, essential performance is: no knife movement without activation of the firing trigger.
Guidance and manufacturer's declaration—electromagnetic immunity
The ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter is intended for use in the electromagnetic environment
specified below. The customer or the user of the ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter should ensure
that it is used in such an environment.
IEC 60601
IMMUNITY test
test level
Electrostatic
± 6 kV contact ± 6 kV contact
discharge (ESD)
± 8 kV air ± 8 kV air
IEC 61000-4-2
± 2 kV for power
Electrical fast
supply lines
transient/burst
Not applicable
± 1 kV for input/output
IEC 61000-4-4
lines
Surge ± 1 kV line(s) to line(s)
Not applicable
IEC 61000-4-5 ± 2 kV line(s) to earth
<5 % U
T
(>95 % dip in U
)
T
for 0.5 cycle
Voltage dips, short 40 % U
T
interruptions and voltage (60 % dip in U )
T
variations on power for 5 cycles
Not applicable
supply input lines 70 % U
T
(30 % dip in U )
T
IEC 61000-4-11 for 25 cycles
<5 % U
T
(>95 % dip in U )
T
for 5 s
Power frequency
(50/60 Hz)
3 A/m
magnetic field
IEC 61000-4-8
NOTE U is the a.c. mains voltage prior to application of the test level.
T
Electromagnetic environment - guidance
Electromagnetic environment —
Compliance level
guidance
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30 %.
Not applicable
Power frequency magnetic fields should be at levels
3 A/m characteristic of a typical location in a typical
commercial or hospital environment.
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Guidance and manufacturer's declaration—electromagnetic immunity
The ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter is intended for use in the electromagnetic environment
specified below. The customer or the user of the ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter should ensure
that it is used in such an environment.
IEC 60601 TEST
IMMUNITY test
LEVEL
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.
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
ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter is used exceeds the applicable RF compliance level above, the
ECHELON FLEX 60 mm Powered Plus Articulating Endoscopic Linear Cutter 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 60 mm Powered Plus
Articulating Endoscopic Linear Cutter
Compliance Electromagnetic environment –
level guidance
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 Not Applicable
3 V/m
80 MHz to 800 MHz
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 recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic
site survey, should be less than the
a
compliance level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
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