Earlens Photon Instructions Manual page 33

11.4. Electromagnetic Compatibility Compliance Statement
•
Medical Electrical Equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in the
Accompanying Documents.
•
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
•
The equipment or system should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, the equipment or system should be
observed to verify normal operation in the configuration in which it will be used. The following
accessories supplied with the Earlens Hearing Aid have been tested for electromagnetic
emissions compliance.
Cable Type Cable Description
USB Cable Hi-speed 2.0
Shielded
The use of accessories, transducers and/or cables other than those specified, with the exception of those
sold by the manufacturer as replacement parts for internal components, may result in increased emissions
or decreased immunity of the equipment or system.
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
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.
Emissions Test
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonics
IEC 61000-3-2
Flicker
IEC 61000-3-3
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
ESD ±6kV Contact
IEC 61000-4-2 ±8kV Air
EFT ±2kV Mains
IEC 61000-4-4 ±1kV I/Os
Surge ±1kV Differential
IEC 61000-4-5 ±2kV Common
List of all cables utilized with the Earlens Hearing Aid
Maximum Cable
Length
80 inches
Compliance
Group 1
Class B
Class A
Complies
Guidance and Manufacturer's Declaration – Immunity
Compliance
Level
±8kV Contact*
±15kV Air*
±2kV Mains
±1kV I/Os
±1kV
Differential
±2kV Common
Cable
Manufacturer
TrumPower
Electromagnetic Environment - Guidance
The Earlens Hearing Aid does not use RF
energy for any of its functions. Therefore, its
RF emissions are very low and are not likely
to cause any interference in nearby electronic
equipment.
The Earlens Hearing Aid
all establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
Electromagnetic Environment - Guidance
Floors should be wood, concrete or ceramic
tile. If floors are synthetic, the R/H should be at
least 30%
Mains power quality should be that of a typical
home, commercial or hospital environment.
Mains power quality should be that of a typical
home, commercial or hospital environment.
Cable Model Number
E189529
is suitable for use in
IFU00022vJ
33