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Medivance Simply Advanced Arctic Sun 5000 Manuel De L'opérateur page 14

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TEMPERATURE MANAGEMENT SYSTEM
Appendix C: Electromagnetic Compatibility (continued)
1.3 EN/IEC 60601-1-2:2007 Sub-clause 5.2.2.2 Table 4:
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Arctic Sun™ Temperature Management System unit is intended for use in the
electromagnetic environment specified below. The customer or the end user of the
Arctic Sun™ Temperature Management System unit should assure it is used in such an
environment.
Immunity
IEC 60601
Compliance
Test
test level
Level
Conducted
3Vrms
3Vrms
RF
150kHz to
150kHz to
IEC 61000-4-6
80MHz
80MHz
Radiated RF
3V/m
3V/m
IEC 61000-4-3
80MHz to
80MHz to
2.5GHz
2.5GHz
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 objects, structures and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/
a
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
Arctic Sun™ Temperature Management System unit is used exceeds the applicable
RF compliance level above, the Arctic Sun™ Temperature Management System unit
should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the
Arctic Sun™ Temperature Management System unit.
Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
b
14
Intended Electromagnetic Environment
Portable and mobile RF communications
equipment should be used no closer to
any part of the Arctic Sun™ Temperature
Management System unit, 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 800 MHz
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 minimum separation distance
in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey
, should be less than the compliance
a
level in each frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following symbol:
1.4 EN/IEC 60601-1-2:2007 Sub-clause 5.2.2.2 Table 6:
Recommended separation distances between portable and mobile RF communications
equipment and the Arctic Sun™ Temperature Management System unit
RF communications equipment can effect medical electrical equipment. The
Arctic Sun™ Temperature Management System unit is intended for use in an
electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the Arctic Sun™ Temperature Management System unit
can help prevent electromagnetic interference by maintaining a minimum distance
between the portable and mobile RF communications equipment (transmitters) and
the Arctic Sun™ Temperature Management System unit as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
Separation distance according to frequency of transmitter in meters
output power of
(m)
transmitter in
150kHz to 80MHz
watts (W)
d = 1.2√P
0.01
0.12
0.1
0.38
1.0
1.2
10
3.8
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.
O P E R A T O R ' S M A N U A L
80MHz to 800MHz
800MHz to 2.5GHz
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

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