DJO Global cefar basic Mode D'emploi page 54

54
The CEFAR BASIC Electrotherapy System is intended for use in the electromagnetic environment specified below. The customer
or the user of the CEFAR BASIC Electrotherapy System 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
(50/60Hz) magnetic field
IEC 61000-4-8
NOTE: U T is the AC mains voltage prior to application of the test level.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
IEC 60601
Test Level
±6kV contact
±8kV air
±2kV for power supply lines
±1kV for input/output lines
+ 1kV differential mode (line
to line)
+ 2kV common mode (line
to ground)
<5% U T (>95% dip in U T ) for
0,5 cycle
40% U T (60% dip in U T ) for
5 cycles
70% U T (30% dip in U T ) for
25 cycles
<5% U T (>95% dip in U T ) for
5 sec
3 A/m
Electromagnetic Environment -
Compliance Level
Risk assessment on the CEFAR
BASIC Electrotherapy System
±6kV contact
indicates the compliance levels
±8kV air
claimed are acceptable when ESD-
precautionary measures are taken.
Not Applicable - Battery
Mains power quality should be
powered
that of a typical commercial or
Not Applicable - signal lines
hospital environment.
less then 3 meters
Mains power quality should be
Not Applicable - Battery
that of a typical commercial or
powered
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the CEFAR BASIC Electrotherapy
System requires continued
Not Applicable - Battery
powered
operation during power mains
interruptions, it is recommended
that the CEFAR BASIC Electro-
therapy System be powered from
an uninterrupted 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.
Guidance