17
Fields located near RF
wireless communication
devices
IEC 61000-4-3
COMPLIANT
NOTE: Further information about distances to be main-
tained between portable and mobile RF communica-
tions equipment (transmitters) and the Mister 8
02038211000000 can be requested from PIKDARE S.r.l. us-
ing the contact information provided in this manual. It is
nevertheless advisable to keep a safe distance (at least 1
m) between the electromechanical aerosol therapy device
and mobile phones or other RF communications devices in
order to minimise possible interference.
Magnetic fields at
NOMINAL mains frequency.
IEC 61000-4-8
30 A/m
c
)
50 Hz or 60 Hz
a
) The device is destined for household use or use in professional healthcare facilities and may only be used in the patient's
room and in locations designated for respiratory therapy in a hospital or clinic. The most restrictive limits were applied
for the immunity tests.
b
) Before modulation.
c
) This test level presupposes a minimum distance of at least 15 cm between the piece of piece of ME EQUIPMENT or the
ME SYSTEM and the sources of electromagnetic fields at mains frequency.
Guidelines and Manufacturer's Declaration - Electromagnetic Immunity - Alternating Current Entry Port
Phenomenon
EMC Regulation or test
method
Immunity test levels
Professional healthcare
facilities
Household environment
Electrical fast transient/
burst
IEC 61000-4-4
± 2 kV
100 kHz frequency of repetition
Line-to-earth surges
IEC 61000-4-5
± 0.5 kV, ±1 kV
Line-to-earth surges
IEC 61000-4-5
Class II device or equipped with Class II AC/DC adapter.
Test not applicable
Conducted disturbances
induced by radio
frequency fields.
IEC 61000-4-6
3 V
a
) 0.15 MHz - 80 MHz
6 V
a
) for ISM bands between 0.15 MHz and 80 MHz
b
)
80% AM at 1 kHz
Voltage dips.
IEC 61000-4-11
0% in UT; 0.5 cycles
At 0°,45°,90°,135°,180°, 225°, 270° and 315°.
0% in UT; 1 cycle and 70% in UT; 25/30 cycles
Monophase: at 0°
Short interruptions
c
)
IEC 61000-4-11
0% in UT; 250/300 cycles
a
) RMS value before modulation.
b
) The frequency bands from 0.15 MHz to 80 MHz used by industrial, scientific and medical (ISM) radiofrequency devices are: 6.765
MHz - 6.795 MHz, 13.553 MHz - 13.567 MHz, 26.957 MHz - 27.283 MHz and 40.66 MHz - 40.70 MHz. The radio bands from 0.15 MHz
to 80 MHz used for amateur radio are: 1.8 MHz - 2.0 MHz, 3.5 MHz - 4.0 MHz, 5.3 MHz - 5.4 MHz, 7 MHz - 7.3 MHz, 10.1 MHz - 10.15
MHz, 14 MHz - 14.2 MHz, 18.07 MHz - 18.17 MHz, 21.0 MHz - 21.4 MHz, 24.89 MHz - 24.99 MHz, 28.0 MHz - 29.7 MHz and 50.0
MHz - 54.0 MHz.
c
) ME EQUIPMENT with direct current input for use with an AC/DC adapter, tested using an adapter compliant with the
specifications provided by the ME EQUIPMENT MANUFACTURER. THE IMMUNITY TEST LEVEL was applied at the adapter's
alternating current entry point.
Summary of Contents for 02038211000000
Page 1: ...Mister 8...
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Page 3: ...3 2 3 4 7 5 6 8 9 10 2 4 8 6 2 4 8 6 2 4 8 6 F1 D C I F B A E 1 H M 2 4 8 6 2 4 8 6 L G N...
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