Casa Nuova 4, Руководство по эксплуатации

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Guidance and manufacturer‘s declaration
Recommended separation distances between
portable and mobile RF communications equipment and the PRODUCT
for not life supporting equipment and systems
(*IEC/EN 60601-1-2, Table 6)
* edition: see page 1 – standard(s)
The PRODUCT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the PRODUCT can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the PRODUCT as recommended below, according to the
maximum output power of the communications equipment.
Separation distance (d) according to frequency of transmitter
[m]
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
Rated
maximum
output power
of transmitter
[W]
d = 1,2 (P)
1/2
d = 0,4 (P)
1/2
d = 0,7 (P)
1/2
0,01 0,12 0,04 0,1
0,1 0,38 0,13 0,22
1 1,2 0,4 0,7
10 3,8 1,3 2,21
100 12 4 7
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.
Casa Med Classic 4 / Classic FS / Casa Med Ultra / Casa Med Ultra FS / Casa Med Low 01.01.2012
GB – 31
Additional_Information_EMC_IPROXXX_EN60601-1-2_REV00.docx Page6 of 7
Guidance and manufacturer‘s declaration
– Electromagnetic Immunity -
for not life supporting equipment and systems
(*IEC/EN 60601-1-2, Table 4)
* edition: see page 1 – standard(s)
The PRODUCT is intended for use in the electromagnetic environment specified below. The customer or the user of the
PRODUCT should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic environment –
guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the PRODUCT, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
Conducted RF
IEC 61000-4-6
3 V
eff
150 kHz to 80 MHz
3 V
eff
d = 1,2 (P)
1/2
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2500 MHz
10 V/m d = 0,4 (P)
1/2
80 MHz to 800 MHz
d = 0,7 (P)
1/2
800 MHz to 2,5 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
a
should be less than the compliance level in each
frequency range
b
.
Interference may occur in the vicinity of
equipment marked with the following symbol:
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 PRODUCT is used exceeds the applicable RF compliance level above,
the PRODUCTshould be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the PRODUCT.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and manufacturer‘s declaration
– Electromagnetic Immunity -
for life supporting equipment and systems
(*IEC/EN 60601-1-2, Table 3)
* edition: see page 1 – standard(s)
The PRODUCT is intended for use in the electromagnetic environment specified below. The customer or the user of the
PRODUCT should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic environment –
guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the PRODUCT, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter
Recommended separation distance:
3 V
rms
150 kHz to 80 MHz
outside ISM bands
a
3 V
rms
d = 1,2 (P)
1/2
Conducted RF
IEC 61000-4-6
10 V
rms
150 kHz to 80 MHz
in ISM bands
a
10 V
rms
d = 1,2 (P)
1/2
d = 1,2 (P)
1/2
80 MHz to 800 MHz 10 V/m
80 MHz to 2,5 GHz
10 V/m
d = 2,3 (P)
1/2
800 MHz to 2,5 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 ).
b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
c
,
should be less than the compliance level in each
frequency range
d
.
Radiated RF
IEC 61000-4-3
Interference (from a mobile phone for example),
may occur in the vicinity of equipment marked
with the following symbol:
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
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to
13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5
GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is
inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formulae
used in calculating the recommended separation distance for transmitters in these frequency ranges.
c 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 PRODUCT is used exceeds the applicable RF compliance level above,
the PRODUCT should be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the PRODUCT..
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Casa Med Classic (FS) / Casa Med Classic Low / Casa Med Ultra (FS) – 15.09.2011
GB – 26
Casa Med Classic 4 / Classic FS / Casa Med Ultra / Casa Med Ultra FS / Casa Med Low 01.01.2012
Casa Nuova 4 / Casa Nuova Bariatric
June 2017