Bioventus EXOGEN Guia Del Usuario página 32

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
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient/
burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
Power frequency (50/60 Hz) mag-
netic field IEC 61000-4-8
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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 TV broadcast
a
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.
Warning: The use of chargers, transducers or cables, other than those supplied, may result in increased radio frequency emissions or decreased electromagnetic immunity of the EXOGEN which
may cause EXOGEN to stop working.
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IEC 60601 Test Level
±8 kV contact
±2 kV, ±4 kV, ±6 kV,
±8 kV, ±15 kV air
±2 kV
100 kHz repetition
frequency
±0.5 kV, ±1 kV Line-to-line
±0.5 kV, ±1 kV, ±2 kV
Line-to-ground
0% U ; 0.5 cycle
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At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0% U ; 1 cycle
T
70% U ; 25/30 cycles
T
Single phase: at 0°
0% U ; 250/300 cycle
T
30 A / m
50/60 Hz
3 Vrms
6 Vrms
(In ISM and amateur radio
bands)
150 kHz to 80 MHz
10 V/m
80 MHz - 2.7 GHz
80% AM at 1 kHz
Compliance Level Electromagnetic environment - guidance
±8 kV contact Floors should be wood, concrete or ceramic tile. If floors are covered with
±2 kV, ±4 kV, ±6 kV, synthetic material, the relative humidity should be at least 30%
±8 kV, ±15 kV air
±2 kV Mains power quality should be that of a typical commercial or hospital environ-
100 kHz repetition ment.
frequency
±0.5 kV, ±1 kV Line-to-line Mains power quality should be that of a typical commercial or hospital environ-
ment.
Line-to-ground – Not
Applicable
0% U ; 0.5 cycle Mains power quality should be that of a typical commercial or hospital envi-
T
At 0°, 45°, 90°, 135°, 180°, ronment. If the user of EXOGEN requires continued operation during power
225°, 270° and 315° mains interruptions, it is recommended that EXOGEN be powered from an
uninterruptible power supply or a battery.
0% U ; 1 cycle
T
70% U ; 25/30 cycles
T
Single phase: at 0°
0% U ; 250/300 cycle
T
30 A / m Power frequency magnetic fields should be at levels characteristic of a typical
50/60 Hz location in a typical commercial or hospital environment.
3 Vrms Portable and mobile RF communications equipment should be used no closer
to any part of EXOGEN, including cables, than the recommended separation
6 Vrms
distance calculated from the equation applicable to the frequency of the trans-
mitter. Recommended separation distance:
(In ISM and amateur radio
bands)
d = 1.2 √P
150 kHz to 80 MHz
d = 1.2 √P 80 MHz to 800 MHz
10 V/m
d = 2.3 √P 800 MHz to 2.5 GHz
80 MHz - 2.7 GHz
80% AM at 1 kHz 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,
pliance level in each frequency range.
equipment marked with the following symbol:
should be less than the com-
a
Interference may occur in the vicinity of
b