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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.
List of all cables utilized with the Earlens Hearing Aid
Cable Type
Cable Description
Maximum Cable
Length
Cable
Manufacturer
Cable Model Number
USB Cable
Hi-speed 2.0
Shielded
80 inches
TrumPower
E189529
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
Compliance
Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
Group 1
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.
RF Emissions
CISPR 11
Class B
The
Earlens Hearing Aid
is suitable for use in
all establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
Harmonics
IEC 61000-3-2
Class A
Flicker
IEC 61000-3-3
Complies
Guidance and Manufacturer’s Declaration – 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
Compliance
Level
Electromagnetic Environment - Guidance
ESD
IEC 61000-4-2
±6kV Contact
±8kV Air
±8kV Contact*
±15kV Air*
Floors should be wood, concrete or ceramic
tile. If floors are synthetic, the R/H should be at
least 30%
EFT
IEC 61000-4-4
±2kV Mains
±1kV I/Os
±2kV Mains
±1kV I/Os
Mains power quality should be that of a typical
home, commercial or hospital environment.
Surge
IEC 61000-4-5
±1kV Differential
±2kV Common
±1kV
Differential
±2kV Common
Mains power quality should be that of a typical
home, commercial or hospital environment.
