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17
TECHNICAL SPECIFICATIONS AND ENVIRONMENTAL REQUIREMENTS
Guidance and Manufacturer’s Declaration-Immunity
The Generator is intended for use in the electromagnetic environment specified below. The customer or user of the Generator should
ensure that it is used in such an environment.
Immunity Test IEC 60601-1-2, 3rd edition
Compliance Level
IEC 60601-1-2, 4th
edition Compliance Level
Electromagnetic Environment-Guidance
ESD
IEC 61000-4-2
±6 kV Contact
±8 kV Air
±8 kV Contact
±15 kV Air
Floors should be wood, concrete or ceramic
tile. If floors are synthetic, the relative
humidity should be at least 30%.
EFT
IEC 61000-4-4
±2 kV Mains
±1 kV I/Os
±2 kV Mains
±1 kV I/Os
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV Differential
±2 kV Common
±1 kV Differential
±2 kV Common
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage Dips/ Dropout
IEC 61000-4-11
<5% UT for
0.5 Cycle
40% UT for
5 Cycles
70% UT for
25 Cycles
<5% UT for
5 Seconds
0% UT for
0.5 Cycle
0% UT for
1 Cycle
70% UT for
25/30 Cycles
0% UT for
250/300 Cycles
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the Generator requires
continued operation during power
mains interruptions, it is recommended
that the Generator be powered from an
uninterruptible power supply or baery.
Power Frequency
Magnetic Field IEC 61000-4-8
3 A/m, 50/60 Hz 30 A/m, 50/60 Hz Power frequency magnetic fields should be that
of a typical commercial or hospital environment.
Table 3 —Guidance and Manufacturer’s Declaration—Immunity All ME Equipment and ME Systems