Creo Medical 7-EMR-050 Instructions D'utilisation page 37

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.
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
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.
IEC 60601-1-2 Test
Level
±8 kV Contact
±2,4,8,15 kV Air
±2 kV for Power
Supply Lines
±1 kV for Input /
Output Lines
±1 kV Differential
Mode
±2 kV Common Mode
i) 0 % UT; 0.5 cycle, at
0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°;
ii) 0 % UT for 1 cycle at
0°; and
iii) 70 % UT for 25/30
cycles at 0°
iv) 0 % UT for 250/300
cycles
30 A/m
Electromagnetic Environment –
Compliance Level
Guidance
±8 kV Contact = A
Floors should be wood, concrete or
±15 kV Air = A ceramic tile. If floors are covered with
synthetic material, the relative humidity
±15 kV Air = C Rear
should be at least 30%.
panel switch
AC power quality should be that of a
A
typical hospital environment.
±1 kV Differential
Mode = C
AC power quality should be that of a
typical hospital environment.
±2 kV Common
Mode = C
AC power quality should be that of a
typical hospital environment. If the user
i), III) = A
of the Electrosurgical Generator requires
continued operation during power AC
interruptions, it is recommended that
ii) and iv) = C
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
A
location in a hospital environment.
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