Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Bioventus EXOGEN Manual Del Usuario

Guidance and manufacturer's declaration – electromagnetic immunity
EXOGEN is intended for use in the electromagnetic environment specified below. The customer or the user of the EXOGEN should assure that it is used in
such an environment.
Immunity test IEC 60601 Test Level
Electrostatic discharge ±6 kV contact
(ESD) ±8 kV air
IEC 61000-4-2
Electrical fast transient/ ±2 kV for power supply
burst lines
IEC 61000-4-4 ±1 kV for input/output
lines
Surge ±1 kV differential mode
IEC 61000-4-5 ±2 kV common mode
Voltage dips, short <5% U
interruptions and voltage (>95% dip in U
variations on power cycle; 40% U
supply input lines IEC in U
T
61000-4-11 U (30% dip in U
T
cycles; <5% U
dip in U
Power frequency (50/60 3 A / m
Hz) magnetic field IEC
61000-4-8
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m
IEC 61000-4-3 80 MHz to 2,5 GHz
NOTE U is the a.c. mains voltage prior to application of the test level.
T
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.
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
a
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 EXOGEN is used exceeds the applicable RF compliance level above, EXOGEN should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating EXOGEN.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.
b
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the EXOGEN device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
Labeling LBL-000319 [D] RELEASED
29
Compliance Level
±6 kV contact
±8 kV air
±2 kV for power supply
lines
Not Applicable for input/
output lines
±1 kV differential mode
±2 kV common mode
<5% U
T T
) for 0,5 (>95% dip in U
T
(60% dip cycle; 40% U (60% dip
T T
) for 5 cycles; 70% in U ) for 5 cycles; 70%
T
) for 25 U (30% dip in U
T T
(>95 % cycles; <5% U
T T
) for 5 sec dip in U ) for 5 sec
T T
3 A / m
3 Vrms
3 V/m
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.
Mains power quality should be that of a typical commercial or hospital environment. If the user of EXOGEN
) for 0,5 requires continued operation during power mains interruptions, it is recommended that EXOGEN be pow-
T
ered from an uninterruptible power supply or a battery.
) for 25
T
(>95 %
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical com-
mercial or hospital environment.
Portable and mobile RF communications equipment should be used no closer to any part of
EXOGEN, 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 80 MHz to 800 MHz
d = 2.3 √P 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 meters (m). Field strengths from fixed RF
transmitters, as determined by an electromagnetic site survey,
in each frequency range.
symbol:
should be less than the compliance level
a
Interference may occur in the vicinity of equipment marked with the following
b