Ulthera DeepSEE DS 4 - 4.5 Instructions For Use Manual page 27

W arning: The Ulthera system should not be used adjacent to, or stacked
with other electronic equipment. If the system must be installed in close
proximity to other equipment, both Ulthera and the nearby equipment
should be observed to verify normal operation in that configuration.
4.5.2. Guidance and Manufacturer's Declaration – Electromagnetic
I mmunity
Table 4.6 Electromagnetic Immunity
IMMUNITY TEST
Electrostatic
discharge
(ESD)
IEC 6100-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions
and v oltage
v ariations on
power supply
input lines IEC
61000-4-11
Power
Frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Ulthera, Inc.
IEC 60601 TEST COMPLIANCE LEVEL
LEVEL
±6 kV contact ±6 kV contact
±8kV air ±8kV air
±2kV for power ± 2kV for power
supply lines supply lines
±1kV for ±1kV for
input/output lines input/output lines
±1 kV differential ±1 kV differential
mode mode
±2 kV common ±2 kV common
mode mode
<5% U r <5% Ur
(>95% dip in U r ) (>95% dip in Ur)
for 0,5 cycle for 0,5 cycle
40% U r
40% U r (60% dip
in U r ) for 5 cycles
(60% dip in U r )
for 5 Cycles
70% Ur (30% dip in
Ur) for 25 cycles
70% U r (30% dip
in U r ) for 25 <5% Ur (>95% dip
cycles in Ur) for 5 sec
<5% U r (>95% dip
in U r ) for 5 sec
3 A/m 3 A/m at 50 and
60Hz
ELECTROMAGNETIC
ENVIRONMENT -
GUIDANCE
Floors should be wood,
concrete or ceramic
tile. If floors are cov ered
with synthetic material,
the relativ e humidity
should be at least 30%.
Mains power quality
should be that of a
typical commercial or
hospital env ironment.
Mains power quality
should be that of a
typical commercial or
hospital env ironment.
Mains power quality
should be that of a
typical commercial or
hospital env ironment. If
the user of the Ulthera
system requires
continued operation
during power mains
interruptions, it is
recommended that
Ulthera be powered
from an uninterruptible
power supply.
Power frequency
magnetic fields should
be at lev els
characteristic of a
typical location in a
typical commercial or
hospital env ironment.
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