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MU_Brizzy
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_NS26_REV 1_EN /09-2019
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Guidance and manufacturer’s declaration – electromagnetic immunity
Environment adapted to the use:
is suitable for use in all premises, including domestic premises and those directly connected
to the public low-voltage power supply network supplying buildings for domestic use.
Essential performance:
The recording of physiological parameters during sleep to allow the detection, by visual or automatic
analysis of recorded signals, of events related to sleep disorders must not be adversely affected.
Recommendations:
See the chapter "Warnings and Safety Instructions".
Conformity to tests:
has been declared compliant with the emission and immunity tests required by the standard
"EN 60601-1-2:2015" with the essential performance criterion listed above.
The table below shows all the tests and compliance levels:
Emissions test
Conformity
Emissions RF
CISPR 11
Class B
Harmonic Emissions
CEI 61000-3-2
Not applicable
Voltage fluctuations / Flicker emissions
CEI 61000-3-3
Not applicable
Immunity test
Conformity
Electrostatic discharge (ESD)
CEI 61000-4-2
+/- 8kV contact
+/- 2kV, +/- 4kV, +/- 8kV, +/- 15kV air
Radiated RF
CEI 61000-4-3
10 V/m
80 MHz - 2,7 GHz
Modulation according to Table 9 of
EN60601-1-2:2015
Electrical fast transient / burst
CEI 61000-4-4
Not applicable
Surge
CEI 61000-4-5
Not applicable
Conducted RF
CEI 61000-4-6
6 V/m
0.15 MHz – 80 MHz
Magnetic field (50/60 Hz)
CEI 61000-4-8
30 A/m
50Hz
Voltage dips, short interruptions and voltage variations
on power supply input lines
CEI 61000-4-11
Not applicable
Summary of Contents for Brizzy+
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