29
guidance and manufacturer’s declaration — electromagnetic emissions
The EndoPilot is intended for use in the electromagnetic environment specified below. The
customer or the user of the EndoPilot should assure that is used in such an environment.
Immunity test
IEC60601 test level
Compliance Level
Electromagnetic en-
vironment - guide
Electrostatic
discharge(ESD)
EN 61000-4-2
±6kV contact
± 8kV air
± 6kV contact
± 8kV air
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
shouId be at least
30%.
Electrical fast
transient/burst,
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
Output lines
± 2 kV for power
supply lines
Mains power quality
should be that of a
typical commercial or
hospital
environment.
Surge
IEC 61000-4-5
±1 kV line to line
±2 kV line to erath
±1 kV line to line
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Voltage dips,
short
interruptions
and voltage varia-
tions on power
supply input lines
IEC 61000-4-11
< 5 % UT
( > 95 % dip in UT)
For 0.5 cycles
40% UT
( 60 % dip in UT) for 5
cycles
< 5 % UT 70 % UT
( 30 % dip in UT)
for 25 cycles
< 5 % UT
< 5 % UT
( > 95 % dip in UT)
for 5 s
< 5 % UT
(> 95 % dip in UT
400/UT
( 60 % dip in UT) for
5 cycles
< 5 % UT 70 % UT
( 30 % dip in UT)
for 25 cycles
< 5 % UT
< 5 % UT
( > 95 % dip in UT
for 5s
Mains power quality
should be that of a
typical commercial or
hospital
environment. If the
user of the EndoPilot
requires continued
operation during
power mains
interruptions, it is
recommended that
the EndoPilot be
powered from an
uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field IEC
61000-4-8
3 A/m
3 A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital environ-
ment.
NOTE: UT is the ac. mains voltage prior to application of the test level.