Table of Contents
Advertisement
Fast electric
EN 61000-4-4:2012 (IEC 61000-4-4:2012)
transients (Burst)
(Test Levels: ±2 kV AC ports, ±1 kV Signal
ports)
Surges
EN 61000-4-5:2014 (IEC 61000-4-5:2014)
(Test Levels: ±1 kV L-N)
Radio frequency
EN 61000-4-6:2014 (IEC 61000-4-6:2013)
common mode
(Frequencies: 0.15-80 MHz; Test levels: 10 V,
Modulation 1kHz, 80%AM)
Magnetic fields
EN 61000-4-8:2010 (IEC 61000-4-8:2009)
(industrial
(Frequencies: 50 Hz or 60 Hz, Test levels: 30
frequencies)
A/m)
Voltage dips and
EN 61000-4-11:2004 (IEC 61000-4-11:2004)
interruptions
(Test Levels: 0% at 0, 45, 90, 135, 180, 225,
270, 315° for 10,20,5000 ms /70% at 0°for500
ms; 0% at 0, 45, 90, 135, 180, 225, 270, 315°
for 0.5, 1, 250/300 cycles /70% at 0° for 25/30
cycles)
Variations of power
IEC 60601-1 (§ 4.10.2):2005
frequency
(Test levels: 50 +/- 1 Hz and 60 +/- 1 Hz)
38
8. Information and explanation
of symbols
Regulatory labels not visible on the product can
be accessed by pressing the volume down key for
5 sec. while starting Roger NeckLoop. Toggle
through the information shown in the display by
pressing the volume down button.
With the CE symbol, Sonova AG confirms
that this product – including accessories
– meets the requirements of the Medical
Device Regulation (EU) 2017/745 as well as
the Radio Equipment Directive 2014/53/EU.
The device is a medical device.
Indicates the medical device manufacturer,
as defined in Medical Device Regulation
MDR 2017/745.
Indicates the Authorized representative in the
European Community. The EC REP is also the
importer to the European Union.
39
Advertisement
Table of Contents
