DJO Donjoy IceMan CLEAR3 Instrucciones De Uso página 15

ELECTROMAGNETIC COMPATIBILITY (EMC)
TABLES – RF EMISSIONS CLASS B (con't)
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
Iceman is intended for use in the electromagnetic environment specified below. The
customer or the user of Iceman 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
( Hz)
50/60
Magnetic Fields
IEC
61000-4-8
NOTE: U
is the ac mains voltage prior to application of the test level.
T
IEC 60601 Test
Level
±8 kV contact
±15 kV air
± k
2 V for power
K
supply lines ±1 V
for input/
output lines
±1 KV differential
mode ±2 kV
common mode
Voltage dips of
>95% for 0.5 cycles
30% for 25 cycles
60% for 5 cycles
>95% for 250
cycles (5s)
Inductive loop at
50 Hz and 60 Hz,
to 30 amps (rms)
per meter
Compliance
Level
±8 kV contact
±15 kV air
± k
2 V for power
supply lines ±1 kV
for input/
output lines
±1 kV differential
mode ±2 kV
common mode
Voltage dips of
>95% for 0.5 cycles
30% for 25 cycles
60% for 5 cycles
>95% for 250 cycles
(5s)
Inductive loop at
50 Hz and 60 Hz,
to 30 amps (rms)
per meter
14
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
Iceman 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.