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ForaCare Fora Vital Bedienungsanleitung Seite 15

Blutdrucküberwachungssystem
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Manufacturer's declaration-electromagnetic immunity
The FORA Vital is intended for use in the electromagnetic environment (for home healthcare and
professional healthcare) specified below.
The customer or the user of the FORA Vital should assure that it is used in the environment
specified below.
IEC 60601 test
Compliance
Immunity test
level
Electrostatic
Contact: ±8 kV
Contact: ±8 kV
discharge (ESD)
Air ±2 kV, ±4 kV,
Air ±2 kV, ±4 kV,
IEC 61000-4-2
±8 kV, ±15 kV
±8 kV, ±15 kV
Electrical fast
±2 kV for power
Not applicable
transient / burst
supply lines
IEC 61000-4-4
±1 kV for input /
Not applicable
output lines
Surge IEC
±0.5 kV, ±1 kV
Not applicable
61000-4-5
line(s) to line(s)
±0.5 kV, ±1 kV, ±2
Not applicable
kV line(s) to earth
Voltage
Voltage dips:
Voltage dips:
Dips, short
0 % UT; 0,5 cycle
Not applicable
interruptions
0 % UT; 1 cycle
Not applicable
and voltage
70 % UT; 25/30
Not applicable
variations on
cycles
power supply
input lines IEC
Voltage
Voltage
61000-4-11
interruptions:
interruptions:
0 % UT; 250/300
Not applicable
cycle
Power
30 A/m
30 A/m
frequency(50,
50 Hz or 60 Hz
50 Hz and 60 Hz
60 Hz) magnetic
field IEC 61000-
4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
Electromagnetic environment-
level
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 home healthcare and
professional healthcare environment.
Mains power quality should be that
of a typical home healthcare and
professional healthcare environment.
Mains power quality should be that
of a typical home healthcare and
professional healthcare environment.
If the user of the FORA Vital
requires continued operation during
power mains interruptions, it is
recommended that the FORA Vital
be powered from an uninterruptible
power supply or a battery.
The FORA Vital power frequency
magnetic fields should be at levels
characteristic of a typical location
in a typical home healthcare and
professional healthcare environment.
Manufacturer's declaration-electromagnetic immunity
The FORA Vital is intended for use in the electromagnetic environment (for home healthcare and
professional healthcare) specified below.
The customer or the user of the FORA Vital should assure that it is used in the environment
specified below.
Immunity
IEC 60601
test
test level
Conducted
3 Vrms:
RF
0,15 MHz –
IEC 61000-
80 MHz
4-6
6 Vrms:
in ISM and
am-ateur
radio bands
between
0,15 MHz and
80 MHz
Radiated RF
80 % AM at 1
IEC 61000-
kHz
4-3
10 V/m
80 MHz – 2,7
GHz
80 % AM at 1
kHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply to 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 FORA Vital is used exceeds the
applicable RF compliance level above, the FORA Vital should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the FORA Vital.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
EN-13
Compliance
Electromagnetic environment-guidance
level
Not applicable
Portable and mobile RF communications
equipment must not be used close to any
parts of the FORA Vital including cables, other
Not applicable
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 2,7 GHz
10 V/m
80 MHz – 2,7
Where P is the maximum output power rating
GHz
of the transmitter in watts (W) according to
80 % AM at 1
the transmitter manufacturer and d is the
kHz
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:

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Td-3124b

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