Integra Codman 901001ESUO Instruction Manual page 18

Electrosurgical generator
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TECHNICAL SPECIFICATIONS AND ENVIRONMENTAL REQUIREMENTS
Table 4—Guidance and Manufacturer's Declaration – Electromagnetic Immunity
Reference Table 204 IEC 60601-1-2 3rd edition
Guidance and Manufacturer's Declaration-Immunity
The Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the Generator
should ensure that it is used in such an environment.
Immunity Test
IEC 60601
test level
Conducted RF
3 Vrms
(Mains and I/Os)
150 kHz to 80 MHz
IEC 61000-4-6
3 V/m
Radiated RF IEC
61000-4-3
80 MHz to 2.5 GHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects
and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Generator is used
exceeds the applicable RF compliance level above, the Generator should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the Generator.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Compliance
Electromagnetic Environment – Guidance
level
Portable and mobile RF communications equipment should be used no
closer to any part of the Generator, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency
of the transmitter.
Recommended separation distance:
3 Vrms
d = 1.2 √ P
d = 1.2 √ P 80 MHz to 800 MHz
3 V/m
d = 2.3 √ P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF transmitters
electromagnetic site survey, a should be less than the compliance level in
each frequency range
Interference may occur in the vicinity of equipment marked with the
following symbol:
18
, as determined by an
a
b
.

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