Ulthera DeepSEE DS 4 - 4.5, Instructions For Use Manual

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Ulthera, Inc. Page
27
Warning: 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
Immunity
Table 4.6 Electromagnetic Immunity
IMMUNITY TEST IEC 60601 TEST
LEVEL
COMPLIANCE LEVEL ELECTROMAGNETIC
ENVIRONMENT -
GUIDANCE
Electrostatic
discharge
(ESD)
IEC 6100-4-2
±6 kV contact
±8kV air ±6 kV contact
±8kV air 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%.
Electrical fast
transient/burst
IEC 61000-4-4 ±2kV for power
supply lines
±1kV for
input/output lines ± 2kV for power
supply lines
±1kV for
input/output lines Mains power quality
should be that of a
typical commercial or
hospital env ironment.
Surge
IEC 61000-4-5 ±1 kV differential
mode
±2 kV common
mode ±1 kV differential
mode
±2 kV common
mode Mains power quality
should be that of a
typical commercial or
hospital env ironment.
Voltage dips,
short
interruptions
and v oltage
v ariations on
power supply
input lines IEC
61000-4-11
<5% U r
(>95% dip in U r )
for 0,5 cycle
40%
U r
(60% dip in U r )
for 5 Cycles
70%
U r (30% dip
in U r ) for 25
cycles
<5%
U r (>95% dip
in U r ) for 5 sec
<5% Ur
(>95% dip in Ur )
for 0,5 cycle
40%
U r (60% dip
in U r ) for 5 cycles
70% Ur (30% dip in
Ur ) for 25 cycles
<5% Ur (>95% dip
in Ur ) for 5 sec
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
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m at 50 and
60Hz
Power frequency
magnetic fields should
be at lev els
characteristic of a
typical location in a
typical commercial or
hospital env ironment.