Medivance Simply Advanced Arctic Sun 5000 Manual De Instrucciones página 12

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 A S 5000 Temperature Management System unit is intended for use in
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the electromagnetic environment specified below. The customer or the end user of the
A S 5000 Temperature Management System unit should assure it is used in
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such an environment.
Immunity IEC60601 Compliance
Test test level Level
Conducted 3Vrms 3Vrms
RF 150kHz to 150kHz to
IEC 61000- 80MHz 80MHz
4-6 3V/m 3V/m
Radiated 80MHz to 80MHz to
RF 2.5GHz 2.5GHz
IEC 61000-
4-3
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 A S 5000 Temperature Management System unit is used exceeds the
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applicable RF compliance level above, the A
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 A S 5000 Temperature Management System unit.
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Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
b
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Intended Electromagnetic Environment
Portable and mobile RF communications
equipment should be used no closer to any
part of the A S 5000 Temperature
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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:
S 5000 Temperature Management
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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 A
System unit
RF communications equipment can effect medical electrical equipment. The
A S 5000 Temperature Management System unit is intended for use in an
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electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the A S
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can help prevent electromagnetic interference by maintaining a minimum distance
between the portable and mobile RF communications equipment (transmitters) and
the A S 5000 Temperature Management System unit as recommended
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below, according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter in
output power of meters (m)
transmitter in watts
150kHz to 80MHz
(W)
d = 1.2√P
0.01 0.12
0.1 0.38
1.0 1.2
10 3.8
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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
S 5000 Temperature Management
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5000 Temperature Management System unit
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80MHz to 800MHz 800MHz to
d = 1.2√P 2.5GHz
d = 2.3√P
0.12 0.23
0.38 0.73
1.2 2.3
3.8 7.3
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