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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
±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 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
3 A/m
Compliance 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 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.
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