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Guidance and manufacturer's declaration - electromagnetic immunity
The VarioSurg is intended for use in the electromagnetic environment specified below. The customer or the user of the VarioSurg should assure that it is used in such an environment.
Immunity test
EN/IEC60601 test level
Compliance level
Electromagnetic environment - guidance
Conducted RF EN/IEC61000-4-6
Radiated RF EN/IEC61000-4-3
3Vrms150 kHz to 80MHz
3V/m80MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be used
no closer to any part of the VarioSurg, including cables, than the
recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 P
d = 1.2 P 80MHz to 800MHz
d = 2.3 P 800MHz to 2.5GHz
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 as determined by an
electromagnetic site survey, should be less than the compliance level in
each frequency range.
Interference may occur in the vicinity of equipment marked with the
following symbol:
NOTE 1 At 80MHz and 800MHz, 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 mobiles 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 VarioSurg is used exceeds the applicable RF compliance level above, the VarioSurg should be observed to
verity normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the VarioSurg.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the VarioSurg
The VarioSurg is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the VarioSurg can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VarioSurg as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150kHz to 80MHz
d = 1.2 P
80MHz to 800MHz
d = 1.2 P
800MHz to 2.5GHz
d = 2.3 P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
Cables and accessories
Maximum length
Complies with
Handpiece cord
Foot Controller
2m
2m
RF emissions, CISPR11, EN55011
Harmonic emissions,
Voltage fluctuations/ flicker emission,
Electrostatic discharge(ESD),
Electric fast transient / burst
Surge
Voltage dips, short interruptions and voltage variations on power supply input lines
Power frequency(50/60Hz) magnetic field
Conducted RF
Radiated RF
Class B/ Group 1
EN/IEC61000-3-2
EN/IEC61000-3-3
EN/IEC61000-4-2
EN/IEC61000-4-4
EN/IEC61000-4-5
EN/IEC61000-4-11
EN/IEC61000-4-8
EN/IEC61000-4-6
EN/IEC61000-4-3
Содержание VarioSurg
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