ELECTROMAGNETIC COMPATIBILITY (EMC)
EN
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
Cryo Cuff IC is intended for use in the electromagnetic environment specified below. The customer or the user
of Cryo Cuff IC should assure that it is used in such an environment.
Immunity Tests
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
(50/60Hz)
Magnetic fields
IEC 61000-4-8
NOTE: U
is the a.c mains voltage prior to application of the test level.
T
IEC 60601
Test Level
±8 kV contact
±15 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 cycle
T
40% U
(60% dip in U
T
T
) for 5 cycles
70% U
(30% dip in U
T
T
) for 25 cycles
<5% U
(>95% dip in
T
U
) for 5 sec
T
3 A/m
Compliance Level
±8 kV contact
±15 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 cycle
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 sec
T
30 A/m
10
Electromagnetic Environment -
Guidance
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
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Cold Therapy Unit requires
continued operation during
power mains interruptions, it is
recommended that Cryo Cuff IC be
powered from an uninterrupted
power supply or a battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.