DJO CEFAR REHAB X2 Manual De Instrucciones página 35

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Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The CEFAR REHAB X2 Electrotherapy System is intended for use in the electromagnetic environment specified below. The
customer or the user of the CEFAR REHAB X2 Electrotherapy System should assure that it is used in such an environment
Immunity Test
Electrostatic discharge
±6kV contact
(ESD) IEC 61000-4-2
±8kV air
Electrical fast transient/
±2kV for power supply lines
burst IEC 61000-4-4
±1kV for input/output lines
+ 1kV differential mode (line
Surge
to line)
IEC 61000-4-5
+ 2kV common mode (line
to ground)
<5% U T (>95% dip in U T ) for
Voltage dips, short
0,5 cycle
interruptions and voltage
40% U T (60% dip in U T ) for
variations on power supply
5 cycles
input lines
70% U T (30% dip in U T ) for
25 cycles
IEC 61000-4-11
<5% U T (>95% dip in U T ) for
5 sec
Power frequency
3 A/m
(50/60Hz) magnetic field
IEC 61000-4-8
NOTE: U T is the AC mains voltage prior to application of the test level.
IEC 60601
Compliance Level
Test Level
±6kV contact
±8kV air
Not Applicable - Battery
powered
Not Applicable - signal lines
less then 3 meters
Not Applicable - Battery
powered
Not Applicable - Battery
powered
3 A/m
Electromagnetic Environment -
Guidance
Risk assessment on the CEFAR
REHAB X2 Electrotherapy System
indicates the compliance levels
claimed are acceptable when ESD-
precautionary measures are taken.
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 CEFAR REHAB X2
Electrotherapy System requires
continued
operation during power mains
interruptions, it is recommended
that the CEFAR REHAB X2 Electro-
therapy System be powered from
an uninterrupted power supply.
Power frequency magnetic
fields should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment.
35

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