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Ulthera, Inc.
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The CM1 Motor Module is intended for use in the electromagnetic environment specified
below. The customer or the user of the CM1 Motor Module should assure that it is used in
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
1007270IFU Rev D
®
Cellfina
System
such an environment.
IEC 60601
Compliance
test level
± 6 kV
± 6 kV contact
contact
± 8 kV air
± 8 kV air
± 2 kV for
± 2 kV for
power
power
supply lines
supply lines
± 1 kV line(s)
± 1 kV
to
differential
line(s)
± 2 kV line(s)
± 2 kV common
to earth
<5 % U
<5 % U
T
(>95 % dip in
(>95 % dip in
U
)
T
for 0,5 cycle
for 0,5 cycle
40 % U
40 % U
T
(60 % dip in
(60 % dip in U
U
)
for 5 cycles
T
for 5 cycles
70 % U
70 % U
(30 % dip in U
T
(30 % dip in
for 25 cycles
U
)
<5 % UT
T
for 25 cycles
(>95 % dip in
<5 % UT
(>95 % dip in
for 5 s
U
)
T
for 5 s
3 A/m
3 A/m
is the a.c. mains voltage prior to application of the test level.
T
Electromagnetic environment
– guidance
level
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
mode
hospital environment.
mode
Mains power quality should be
T
that of a typical commercial or
U
)
hospital environment. If the user
T
of the CM1 Motor Module
requires continued operation
T
)
during power mains
T
interruptions, it is recommended
that the CM1 Motor Module be
T
)
powered from an uninterruptible
T
power supply or a battery.
U
)
T
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
User Manual
27 of 214
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