Hologic NovaSure Advanced Instructions For Use And Controller Operator's Manual page 28

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Immunity EN/IEC Compliance
Test 60601 Level
Test Level
Power 3A/m 3A/m
Frequency
50/60Hz
Magnetic
Field
EN/IEC
61000-4-8
Conducted 3 Vrms 3 Vrms
RF
150 kHz to
IEC 80MHz
61000-4-6
Radiated RF 3 V/m 3 V/m
IEC 80 MHz to
61000-4-3 2 .5 GHz
Electromagnetic
Environment – Guidance
Power frequency magnetic
fields should be that of
a typical commercial or
hospital environment .
Portable and mobile
RF communications
equipment should be
used no closer to any
part of the RF generator,
including cables, than the
recommended separation
distance calculated from
the equation applicable
to the frequency of the
transmitter .
Recommended separation
distance
150 kHz to
80 MHz
80 MHz to
800 MHz
800 MHz to
2 .5 GHz
where P is the maximum
output power rating
of the transmitter in
watts (W) 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
a
than the compliance level
in each frequency range .
b
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
Immunity EN/IEC
Test 60601
Test Level
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 .
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
a
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 RF generator is used exceeds the applicable RF compliance
level above, the RF 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 RF generator .
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m .
b
Recommended separation distances between portable
and mobile RF communications equipment and the
NovaSure RF controller
The NovaSure RF controller is intended for use in the
electromagnetic environment in which radiated RF disturbances
are controlled . The customer or the user of the NovaSure RF
controller can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the NovaSure RF
controller as recommended in the following table, according to the
maximum output power of the communications device .
Recommended separation distance
Rated Separation distance according to frequency of
maximum
output power of
transmitter
150 kHz to
W
80 MHz
0 .01 0 .12
0 .1 0 .37
1 1 .2
10 3 .7
100 12
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 .
27
Compliance Electromagnetic
Level Environment – Guidance
transmitter
m
80 MHz to 800 MHz to 2 .5 GHz
800 MHz
0 .12 0 .23
0 .37 0 .74
1 .2 2 .3
3 .7 7 .4
12 23
ENGLISH