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Codman MALIS CMC-III Bedienungsanleitung Seite 13

Bipolar-elektrochirurgiesystem
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Table III Manufacturer's Declaration Regarding Electromagnetic Immunity – Non-life Supporting
The CMC-III Bipolar Electrosurgical System (Model 80-1170 or 80-1172) is intended for use in the electromagnetic environment specified below.
The customer or user must assure that it is used in such an environment.
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
a
Field strengths from fixed transmitters such as base stations for radios, (cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast can not be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey must be considered. If the measured field strength in the location in which the Model 80-1170/80-1172
is used exceeds the applicable RF compliance level above, the Model 80-1170/80-1172 must be observed to verify normal operation. If abnormal
performance is observed, additional measures can be necessary, such as reorienting or relocating the Model 80-1170/80-1172.
b
Over the frequency range of 150 kHz to 80 MHz field strengths must be less than [v1] volts/meter.
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.
CODFR08059xx01v05.indd 13
CODFR08059xx01v05.indd 13
IEC 60601 Test Level
Compliance Level
3 volts/meter RMS
3 Volts RMS
150 kHz to 80 MHz
3 volts/meter
3 volts/meter
80 MHz to 2.5 GHz
Electromagnetic Environment Guidance
Portable and mobile communications equipment must
be used no closer to any part of Models 80-1170 and
80-1172 (including cables) than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance:
D = [3.5/v1]
D = [3.5/E1]
80 MHz
D = [7/E1]
800 MHz – 2.5 GHz
where P is the maximum output power rating to the
transmitter in watts (W) according to the transmitter
manufacturer and D is the recommended separation
distance in meters.
Field strength from fixed RF transmitters as determined
by an electromagnetic site survey
the compliance level in each frequency range
Interference can occur in the vicinity of equipment
marked with the following symbol
(non-ionizing electromagnetic radiation)
13
– 800 MHz
a
must be less than
b
11/6/2008 1:30:53 PM
11/6/2008 1:30:53 PM

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80-117080-1172

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