BD ClipVac Presurgical Hair Removal System Mode D'emploi page 12

REF 5500E/5506 series is intended for use in the electromagnetic environment specified below�
The customer or the user of REF 5500E/5506 series should insure 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 (50/60 Hz)
magnetic field
IEC 61000-4-8
1REF 5500E - Vacuum unit and charger compliance level to ±15 kV air discharge�
2REF 5506A/5506E/5506U/5506K - Battery compliance level to ±8 kV air discharge� Battery fuel gauge LCD display may be damaged at ±15 kV air� But this is not a hazard to the patient�
Note: UΤ is the a�c� mains voltage prior to application of the test level
12
Guidance and manufacturer's declaration — electromagnetic immunity
IEC 60601 test level
±8 kV contact
±15 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV for differential mode
±2 kV common mode
<0% UΤ (>100% dip in UΤ)
for 0�5 cycle (phase angle
0°,45°,90°,135°,180°,225°,270°)
0% UΤ (100% dip in UΤ)
for 1 cycles
70% UΤ (30% dip in UΤ)
for 25/30 cycles
<0% UΤ (>100% dip in UΤ) for 250
cycle
30 A/m
Compliance level
±8 kV contact
±15 1 kV air
±8 kV air
2
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV for differential mode
±2 kV common mode
<0% UΤ (>100% dip in UΤ)
for 0�5 cycle (phase angle
0°,45°,90°,135°,180°,225°,270°)
0% UΤ (100% dip in UΤ)
for 5 cycles
70% UΤ (30% dip in UΤ)
for 25 cycles
<0% UΤ (>100% dip in UΤ) for 250
cycle
30 A/m
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�
Power frequency magnetic fields should be at levels characteristic
of a typical location in a typical commercial or hospital
environment�