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We declare the following hearing aids:
Family BiCore R312
BiCore R312 80
BiCore R312 60
BiCore R312 40
BiCore R312 30
BiCore R312 20
BiCore R312 SDemo
BiCore CROS R312
Demo BiCore CROS R312
are designed and manufactured in conformity with the
European Council Directive 2014/34/EU and have been found
to comply with the Essential Health and Safety Requirements
relating to the design and construction of products intended
for use in potentially explosive atmospheres given in Annex II
to the Directive.
ATEX Group / Class
BiCore R312
II 2D Ex ia IIIC T60°C Db
II 2G Ex ia IIC T6 Gb
I M2 Ex ia I Mb
Applied Standards
EN IEC 60079-0:2018+AC:2020
EN 60079-11:2012
Marking:
Hearing aids conforming to ATEX Directive 2014/34/EU
are under surveillance of the associated Quality Assurance
System by DEKRA EXAM GmbH indicated with the CE mark
CE 0158 on this ATEX supplement, the accompanied
ATEX card and Declaration of Conformity.
DEKRA EXAM GmbH is the Notified Body according to
Annex IV of the Directive.
ATEX group / class is printed on the ATEX card, which must
be available close at hand, when the hearing aids are used
in explosive atmospheres.
Hearing aids will be marked only with the CE mark
CE 0123 of TUEV SUED Product Service GmbH, which
is the Notified Body of WSAUD A/S according to Art 10 (9)
and Annex IX of MDR EU 2017/745.
EU-Type Examination Certificate:
DTI 21ATEX0177X (BiCore R312)
by Danish Technological Institute (0396)
User instructions:
When used in potentially explosive atmospheres, the following
additional instructions to the standard user manual apply:
X For standard batteries: use only CE-marked zinc-air
batteries, IEC type: PR 41 (size: 312)
X Do not use rechargeable battieries
X Do not connect programming units
X Do not use remote controls
X Always carry the ATEX card with you and show it upon
request
Electrical key parameters
1. For all above-mentioned hearing aids
Power supply
Voltage UiDC 1.6 V
Current In3 mA
Data communication
Transmitter-/ receiver
frequency 3.2768 MHz
Radiated power Po65 µW
Bluetooth communication
Transmitter- / receiver
frequency range 2.402 – 2.480 GHz
Radiated power Po1 mW
2. Supply battery size: 312 (IEC type: PR 41)
Voltage UoDC 1.45 V
Current In138 mAs
Rated capacity 180 mAh
User Guide Supplement for ATEX
Hearing aids in potentially explosive atmospheres
Document No. 05296-99T02-7600
Order/Item No. 210 257 48
www.wsaud.com
© 03.2023, WSAUD A/S. All rights reserved
Legal Manufacturer
WSAUD A/S
Nymøllevej 6
3540 Lynge
Denmark
www.rexton.com
0158
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