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ELECTROMAGNETIC IMMUNITY
Immunity
Test
Compliance
Test
Level
Level
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 system is used exceeds the
applicable RF compliance level above, the system should be observed for
normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the Controller.
b
Over the frequency range 150kHz to 79MHz, field strength should be less
than 3 V/m.
ELECTROMAGNETIC EMISSION
Emission Test
Compliance
Group 1
RF Emissions
CISPR 11
Class B
The C2 CryoBalloon™ Ablation System is intended for use in
an electromagnet environment in which radiated RF
disturbances are controlled. The Controller part of the system
is the only electronic component of the system; therefore, the
distances described below only apply to the Controller. The
customer or user of the system can help prevent
electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications
equipment (transmitters) and the Controller as recommended
below, according to the maximum output power of the
communications equipment.
Recommended separation distances between portable and mobile
communications systems and the CryoBalloon Ablation Controller
Rated Max
Separation distance according to frequency of the
Output of
Transmitter
150kHz-79Mhz
(watts)
d=1.2√��
0.01
0.12
0.1
0.38
1
1.2
10
3.8
LBL-1045 Rev
12
Electromagnetic environment
guidance
The recommended separation
distances calculations can be
calculated as follows:
�� = 1.2√�� (�� < 800Mhz)
�� = 2.3√�� (�� ≥ 800Mhz)
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
be less than the compliance level in
b
each frequency range.
Interference may occur in the vicinity
of the equipment marked with the
following symbol:
Electromagnetic environment guidance
The system uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and not likely to
cause any interference in nearby electronic
equipment.
The system is suitable for use in all
establishments, domestic establishments
and those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.
transmitter (meters)
80MHz-799Mhz
800MHz-2.5GHz
d=1.2√��
d=2.3√��
0.12
0.23
0.38
0.73
1.2
2.3
3.8
7.3
100
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 according to the
transmitter manufacturer.
NOTE: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
a
should
objects, and people.
PENTAX Medical
12
12
23
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