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Electromagnetic Emissions Guidance
Guidance and manufacturer's declaration—electromagnetic emissions
The ECHELON FLEX™ Powered Vascular Stapler is intended for use in the electromagnetic environment specified below. The customer or
the user of the ECHELON FLEX™ Powered Vascular Stapler should ensure that it is used in such an environment.
Emissions test
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
RF emissions
CISPR 14-1
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 Powered Vascular Stapler is intended for use in the electromagnetic environment specified below. The customer or the
user of the ECHELON FLEX Powered Vascular Stapler should ensure that it is used in such an environment.
IMMUNITY test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE
U
is the a.c. mains voltage prior to application of the test level.
T
Compliance
Not applicable
The ECHELON FLEX Powered Vascular Stapler is suitable for use in all establish-
ments other than domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
Not applicable
The ECHELON FLEX Powered Vascular Stapler is not suitable for interconnection
Complies
with other equipment.
IEC 60601
test level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input/output
lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
<5 % U
(>95 % dip in U
) for 0.5 cycle
T
T
40 % U
(60 % dip in U
) for 5 cycles
T
T
70 % U
(30 % dip in U
) for 25 cycles
T
T
<5 % U
(>95 % dip in U
) for 5 s
T
T
3 A/m
Electromagnetic environment - guidance
Compliance
level
± 6 kV contact
± 8 kV air
Not applicable
Not applicable
Not applicable
3 A/m
7
Electromagnetic environment –
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 characteristic
of a typical location in a typical
commercial or hospital environment.
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