CU Medical Systems i-PAD CU-SP1 AUTO Instructions For Use Manual page 70

Guidance and manufacturer's declaration – electromagnetic immunity
The i-PAD CU-SP1 AUTO is intended for use in the electromagnetic environment
specified below. The customer or the user of the i-PAD CU-SP1 AUTO should assure 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
IEC 60601-1 test
level
±6 kV Contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV differential
mode
±2 kV common mode
<5 % U (>95% dip in
T
U ) for 0.5 cycles
T
40 % U (60% dip in
T
U ) for 5 cycles
T
70 % U (30% dip in
T
U ) for 25 cycles
T
<5 % U (>95% dip in
T
U ) for 5 s
T
3 A/m
Complianc
e level environment - guidance
±6 kV Floors should be wood, concrete or
Contact ceramic tile. If floors are covered
with synthetic material, the relative
±8 kV air
humidity should be at least 30%
Mains power quality should be that
Not
of a typical commercial or hospital
Applicable
environment
Mains power quality should be that
Not
of a typical commercial or hospital
Applicable
environment.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the i-
PAD CU-SP1 AUTO image
Not intensifier requires continued
Applicable operation during power mains
interruptions, it is recommended
that the i-PAD CU-SP1 AUTO
image intensifier be powered from
an uninterruptible power supply.
3 A/m Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
70
Electromagnetic