Compliance Information - Unitron InseraMD B1-312 Guide D'utilisation

19. Compliance information

Declaration of conformity
Hereby, Sonova AG declares that this product meets the
requirements of the Medical Devices Regulation MDR
2017/745 and complies with Radio Equipment Directive
2014/53/EU. The full text of the EU Declarations of
Conformity can be obtained from the manufacturer via the
following web address:
www.sonova.com/en/certificates.
Australia/New Zealand:
Indicates a device's compliance with applicable
Radio Spectrum Management's (RSM) and
Australian Communications and Media Authority
(ACMA) regulatory arrangements for the legal sale
in New Zealand and Australia. The compliance
label R-NZ is for radio products supplied in the New
Zealand market under conformity level A1.
The hearing aid described in this user guide is certified
under:
Standard hearing system
USA - FCC ID:
Insera B -312 KWC-VTP
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Canada - IC:
2262A-VTP
Notice 1
This device complies with Part 15 of the FCC Rules and
with RSS-210 of Industry Canada. Operation is subject to
the following two conditions:
1) this device may not cause harmful interference, and
2) this device must accept any interference received,
including interference that may cause undesirable
operation.
Notice 2
Changes or modifications made to this device not
expressly approved by Sonova AG may void the FCC
authorization to operate this device.
Notice 3
This device has been tested and found to comply with
the limits for a Class B digital device, pursuant to Part
15 of the FCC Rules and ICES-003 of Industry Canada.
These limits are designed to provide reasonable
protection against harmful interference in a residential
installation. This device generates, uses and can radiate
radio frequency energy and, if not installed and used
in accordance with the instructions, may cause harmful
interference to radio communications. However, there
is no guarantee that interference will not occur in a
particular installation. If this device does cause harmful
interference to radio or television reception, which can be
determined by turning the equipment off and on, the user
is encouraged to try to correct the interference by one or
more of the following measures:
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