GN Danalogic Ambio BRIE - Warnings for Hearing Care Professionals; Statement

50 51
Changes or modicaons can void the user´s authority to operate the
equipment.
The products are in compliance with the following regulatory requirements:
1. In EU: the device conforms to the Essenal Requirements according
to Annex I of Council Direcve 93/42/EEC for medical devices (MDD).
2. Hereby, GN Hearing A/S declares that the radio equipment types BRIE
and VE312 are in compliance with Direcve 2014/53/EU. The full
text of the EU declaraon of conformity is available at the following
internet address: www.declaraons.resound.com
3. In US: FCC CFR 47 Part 15, subpart C.
4. Other idened applicable internaonal regulatory requirements
in countries outside the EU and US. Please refer to local country
requirements for these areas.
5. In Canada: these hearing aids are cered under the rules of ISED.
6. Japanese Radio Law and Japanese Telecommunicaons Business Law
Compliance. This device is granted pursuant to the Japanese Radio
Law (電波法) and the Japanese tele-communicaons Business Law
(電気通信事業法) This device should not be modied (otherwise the
granted designaon number will become invalid.
22 i Warnings for hearing care professionals
1. Special care should be exercised in selecng and ng hearing aids
with maximum sound pressure level that exceeds 132dB SPL with an
IEC 60711:1981 occluded ear sim-ulator. The remaining hearing may
risk further impairment.
2. External devices connected to the electrical input must be safe
according to the require-ments of IEC 60601-1, IEC 60065, or IEC
60950-1, as appropriate (wired connecon, for example HI-PRO,
SpeedLink)
23 Statement
This device complies with part 15 of the FCC rules and ISED rules.
Operaon is subject to the following two condions:
1. This device may not cause harmful interference
2. This device must accept any interference received, including
interference that may cause undesired operaon
i
NOTE: This equipment 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 ISED rules. These limits are designed to provide reasonable
protecon against harmful interference in a residenal installaon. This
equipment generates, uses and can radiate radio frequency energy and,
if not installed and used in accord-ance with the instrucons, may cause
harmful interference to radio com-municaons. However, there is no
guarantee that interference will not occur in a parcular installaon. If
this equipment does cause harmful interference to radio or television
recepon, which can be determined by turning the equipment o and on,
the user is encouraged to try to correct the interference by one or more of
the following measures:
• Reorient or relocate the receiving antenna
• Increase the separaon between the equipment and receiver
• Connect the equipment into an outlet on a circuit dierent from the
one in which the receiver is connected
• Consult the dealer or an experienced radio/TV technician for help