Fora Vital - Page 14

EN-13
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 test
IEC 60601 test
level
Compliance
level
Electromagnetic environment-
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
Contact: ±8 kV
Air ±2 kV, ±4 kV,
±8 kV, ±15 kV
Contact: ±8 kV
Air ±2 kV, ±4 kV,
±8 kV, ±15 kV
Floors should be wood, concrete
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient / burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input /
output lines
Not applicable
Not applicable
Mains power quality should be that
of a typical home healthcare and
professional healthcare environment.
Surge IEC
61000-4-5
±0.5 kV, ±1 kV
line(s) to line(s)
±0.5 kV, ±1 kV, ±2
kV line(s) to earth
Not applicable
Not applicable
Mains power quality should be that
of a typical home healthcare and
professional healthcare environment.
Voltage
Dips, short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30
cycles
Voltage
interruptions:
0 % UT; 250/300
cycle
Voltage dips:
Not applicable
Not applicable
Not applicable
Voltage
interruptions:
Not applicable
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.
Power
frequency(50,
60 Hz) magnetic
field IEC 61000-
4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz and 60 Hz
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.
NOTE
UT
is the a.c. mains voltage prior to application of the test level.
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
test
IEC 60601
test level
Compliance
level
Electromagnetic environment-guidance
Conducted
RF
IEC 61000-
4-6
Radiated RF
IEC 61000-
4-3
3 Vrms:
0,15 MHz –
80 MHz
6 Vrms:
in ISM and
am-ateur
radio bands
between
0,15 MHz and
80 MHz
80 % AM at 1
kHz
10 V/m
80 MHz – 2,7
GHz
80 % AM at 1
kHz
Not applicable
Not applicable
10 V/m
80 MHz – 2,7
GHz
80 % AM at 1
kHz
Portable and mobile RF communications
equipment must not be used close to any
parts of the
FORA Vital including cables, other
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
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 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:
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.