Table 4. Recommended Separation Distances - Hologic MyoSure Manuel D'utilisation

ENGLISH
Table 3 – Guidance and manufacturer's declaration – electromagnetic
immunity
Guidance and manufacturer's declaration – electromagnetic immunity
The MyoSure Hysteroscopic Tissue Removal System is intended for use in the
electromagnetic environment specified below. The customer or the user of the
MyoSure Hysteroscopic Tissue Removal System should assure that it is used
in such an environment.
Immunity IEC Compliance
test 60601 level
test level
Conducted 3 V 3 V
RF
0.15 0.15 MHz -
MHz - 80 MHz
IEC
80 MHz
61000-4-6
6 V in ISM
6 V in ISM and amateur
and radio bands
amateur between
radio 0.15 MHz and
bands 80 MHz
between
80 % AM at
0.15 MHz
1 kHz
and
80 MHz
80 % AM
at 1 kHz
Radiated 3 V/m 3 V/m
RF
80 MHz - 80 MHz -
2.7 GHz 2.7 GHz
IEC
61000-4-3
80% AM 80% AM at 1
at 1 kHz kHz
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 MyoSure Hysteroscopic Tissue Removal System is used exceeds the applicable RF compliance level
above, the MyoSure Hysteroscopic Tissue Removal System should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the MyoSure Hysteroscopic Tissue Removal System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Electromagnetic environment –
guidance
Portable and mobile RF
communications equipment
should be used no closer
to any part of the MyoSure
Hysteroscopic Tissue Removal
System, including cables, than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance (in meters)
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.7 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 metres (m).
Field strengths from fixed RF
transmitters, as determined
by an electromagnetic site
survey, should be less than
a
the compliance level in each
frequency range.
b
Interference may occur in the
vicinity of equipment marked with
the following symbol:
Table 4 – Recommended separation distances between portable and
mobile RF communications equipment and the MyoSure Hysteroscopic
Tissue Removal System
Recommended separation distances between portable and mobile RF
communications equipment and the MyoSure Hysteroscopic Tissue
Removal System
The MyoSure Hysteroscopic Tissue Removal System is intended for use
in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the MyoSure Hysteroscopic
Tissue Removal System can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the MyoSure Hysteroscopic
Tissue Removal System as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum Separation distance according to frequency of
output power of transmitter
transmitter
in meters
W
150 kHz to 80
MHz
d = 1.2√P
0.01 0.12
0.1 0.38
1 1.2
10 3.8
100 12
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in metres (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.
Hologic, Aquilex, MyoSure, and associated logos are trademarks and/
or registered trademarks of Hologic, Inc. and/or its subsidiaries in the
United States and other countries. All other trademarks, registered
trademarks, and product names are the property of their respective
owners.
© 2015-2019 Hologic, Inc.
10
80 MHz to 800 800 MHz to 2.7
MHz GHz
d = 1.2√P d = 2.3√P
0.12 0.23
0.38 0.73
1.2 2.3
3.8 7.3
12 23
AW-13031-002 Rev. 007