Earlens Photon Instructions Manual page 34

Voltage >95% Dip for
Dips/Dropout 0.5 Cycle
IEC 61000-4-11
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
Power 3A/m
Frequency
50/60Hz
Magnetic Field
IEC 61000-4-8
*Compliance was tested at higher levels representative of requirements for home use per IEC 60601-1-2
Edition 4:2014-02
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Earlens Hearing Aid has been successfully tested for use in the electromagnetic environment specified
below. The customer or user of the Earlens Hearing Aid should ensure that it is used in such an
environment, not to exceed conditions listed below.
Immunity Test IEC 60601 Test Level
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
*Compliance was tested at higher levels representative of requirements for home use per IEC 60601-1-2
Edition 4:2014-02
>95% Dip for Mains power quality should be that of a typical
0.5 Cycle home, commercial or hospital environment. If
the user of the Earlens Hearing Aid requires
60% Dip for continued operation during power mains
5 Cycles interruptions, it is recommended that the
Earlens Hearing Aid be powered from an
30% Dip for uninterruptible power supply or battery.
25 Cycles
>95% Dip for
5 Seconds
30 A/m* Power frequency magnetic fields should be that
of a typical home, commercial or hospital
environment.
Compliance
Level
(V1)=3Vrms &
6Vrms in ISM
bands*
(E1)=10V/m*
Electromagnetic Environment –
Guidance
Portable and mobile communications
equipment should be separated from
the Earlens Hearing Aid by no less
than the distances calculated/listed
below:
D=1.2(Sqrt P) [3V Level]
150kHz to 80MHz
D=2(Sqrt P) [6V Level]
150kHz to 80MHz
D=1.2(Sqrt P)
80 to 800 MHz
D=2.3(Sqrt P)
800 MHz to 2.5 GHz
where P is the max power in watts
and D is the recommended separation
distance in meters.
Field strengths from fixed
transmitters, as determined by an
electromagnetic site survey, should
be less than the compliance levels
(V1 and E1).
Interference may occur in the vicinity
of equipment containing a transmitter.
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