Integra Codman 901001ESUO Instruction Manual page 17

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

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