Creo Medical CROMA Instrucciones De Uso página 45

Specifications
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Electrosurgical Generator is intended for use in the electromagnetic environment specified below. The
customer or the user of the Electrosurgical Generator should ensure that it is used in such an environment.
IEC 60601-1-2 Test
Immunity Test
Electrostatic
±8 kV Contact
Discharge (ESD)
±2,4,8,15 kV Air
IEC 61000-4-2
±2 kV for Power
Electrical Fast
Supply Lines
Transient / Burst
±1 kV for Input /
IEC 61000-4-4
Output Lines
±1 kV Differential
Surge Mode
IEC 61000-4-5 ±2 kV Common
Mode
i) 0 % UT; 0.5 cycle,
at 0°, 45°, 90°, 135°,
180°, 225°, 270° and
Voltage
315°;
Dips, Short
Interruptions and
ii) 0 % UT for 1 cycle
Voltage Variations
at 0°; and
on Power Supply
Input Lines
iii) 70 % UT for
25/30 cycles at 0°
IEC 61000-4-11
iv) 0 % UT for
250/300 cycles
Power Frequency
(50/60 Hz)
30 A/m
Magnetic Field
IEC 61000-4-8
NOTE: U is the a.c. voltage prior to application of the test level.
T
Electromagnetic Immunity Notes:
A = Performance of the generator remains unaffected.
C = Generator operation halted, requiring operator intervention to restart using the On/Standby fascia key or On /
Off Power switch. A system re-start could take up to 1 minute to complete.
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Compliance Level
Level
±8 kV Contact = A
±15 kV Air = A
±15 kV Air = C Rear
panel switch
A
±1 kV Differential
Mode = C
±2 kV Common
Mode = C
i), III) = A
ii) and iv) = C
A
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%.
AC power quality should be that of a typical
hospital environment.
AC power quality should be that of a typical
hospital environment.
AC power quality should be that of a typical
hospital environment. If the user of the
Electrosurgical Generator requires continued
operation during power AC interruptions,
it is recommended that the Electrosurgical
Generator be powered from an uninterruptible
power supply or a battery.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
hospital environment.
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