Ameda Elite Anleitung Handbuch - Seite 5

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Ameda Elite Anleitung Handbuch
MEDICAL ELECTRICAL EQUIPMENT needs special precautions
regarding EMC and needs to be installed and put into service
according to the EMC provided in these Instructions for use.
Portable and mobile RF communications equipment can
affect MEDICAL ELECTRICAL EQUIPMENT.
Warning: The use of ACCESSORIES, transducers and cables
other than those specified, with the exception of transducers
and cabled sold by the MANUFACTURER of the Ameda Elite
Guidance and manufacturer's declaration – electromagnetic emissions
The Ameda Elite Breast Pump is intended for use in the
electromagnetic environment specified below.
Emissions test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions
Complies
IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
The Ameda Elite Breast Pump is intended for use in the
electromagnetic environment specified below.
I
test
IEC 60601 test level
Compliance level
MMUNITY
Electrostatic discharge
± 6 kV contact
± 6 kV contact
(ESD) IEC 61000-4-2
± 8 kV air
± 8 kV air
Electrical fast
± 2 kV for power
± 2 kV for power
transient/burst IEC
supply lines/± 1 kV for
supply lines/± 1 kV for
61000-4-4
input/output lines
input/output lines
Surge IEC 61000-4-5
± 1 kV line(s) to line(s)
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 2 kV line(s) to earth
Voltage dips, short
<5% U
(>95% dip in
<5% U
T
interruptions and
U
) for 0,5 cycle
U
) for 0,5 cycle
T
T
voltage variations on
40% U
(60% dip in
40% U
T
power supply input
U
) for 5 cycles
U
) for 5 cycles
T
T
lines IEC 61000-4-11
70% U
(30% dip in
70% U
T
U
) for 25 cycles
U
) for 25 cycles
T
T
<5% U
(>95% dip in
<5% U
T
U
) for 5 s
U
) for 5 s
T
T
Power frequency
3 A/m
3 A/m
(50/60 Hz) magnetic
field IEC 61000-4-8
NOTE: U
is the a.c. mains voltage prior to application of the test level.
T
8
E N G L I S H
Breast Pump as replacement parts for internal components,
may result in increased EMISSIONS or decreased IMMUNITY
of the Ameda Elite Breast Pump.
Warning: The Ameda Elite Breast Pump should not be used
adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the Ameda Elite Breast Pump
should be observed to verify normal operation in the
configuration in which it will be used.
The customer or the user of the Ameda Elite Breast Pump
should assure that it is used in such an environment.
Electromagnetic environment – guidance
The Ameda Elite Breast Pump uses RF energy
only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
The Ameda Elite Breast Pump is suitable for
use in all establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
The customer or the user of the Ameda Elite Breast Pump
should assure that it is used in such an environment.
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
(>95% dip in
Mains power quality should be that of a typical
T
commercial or hospital environment. If the user
(60% dip in
of the Ameda Elite Breast Pump requires
T
continued operation during power mains
(30% dip in
interruptions, it is recommended that the Ameda
T
Elite Breast Pump be powered from an
(>95% dip in
uninterruptible power supply.
T
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Guidance and manufacturer's declaration – electromagnetic immunity
The Ameda Elite Breast Pump is intended for use in
the electromagnetic environment specified below.
I
test
IEC 60601 test
Compliance level
MMUNITY
level
Conducted RF
3 Vrms
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
3 V/m
IEC 61000-4-3
80 MHz to 2,5 GHz
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
Recommended separation distances between portable and mobile RF
communications equipment and the Ameda Elite Breast Pump
The Ameda Elite Breast Pump is intended for use
in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of
the Ameda Elite Breast Pump can help prevent
electromagnetic interference by maintaining a minimum
Separation distance according to frequency of transmitter
Rated maximum output
power of transmitter
150 kHz to 80 MHz
d = 1,2
W
0,01
0,12
0,1
0,38
1
1,2
10
3,8
100
12
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
is the
maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
The customer or the user of the Ameda Elite Breast Pump
should assure that it is used in such an environment.
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should
be used no closer to any part of the Ameda Elite Breast
Pump, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1,2
d = 1,2
80 MHz to 800 MHz
d = 2,3
800 MHz to 2,5 GHz
Where
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 meters (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:
survey should be considered. If the measured field strength in the
location in which the Ameda Elite Breast Pump is used exceeds the
applicable RF compliance level above, the Ameda Elite Breast Pump
should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary,
such as re-orienting or relocating the Ameda Elite Breast Pump.
b Over the frequency range 150 kHz to 80 MHz, field strengths should
be less than 3 V/m.
distance between portable and mobile RF communications
equipment (transmitters) and the Ameda Elite Breast Pump
as recommended below, according to the maximum output
power of the communications equipment.
m
80 MHz to 800 MHz
800 MHz to 2,5 GHz
d = 1,2
d = 2,3
0,12
0,23
0,38
0,73
1,2
2,3
3,8
7,3
12
23
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.
E N G L I S H
9