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Bernafon Encanta 400 Instructions For Use Manual
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Bernafon Encanta 400 Instructions For Use Manual

Bernafon Encanta 400 Instructions For Use Manual

Iic - cic
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INSTRUCTIONS FOR USE
Encanta
IIC - CIC

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Dr. R. J. Mecoy
June 22, 2025

s the Ecanta 400 MRITE R SABE Bernafon ENCANTA 400 MINIRITE R SAND supplied to my wife for trial capable of streaming with the Streamline TV Apparatus? My Signia C & G 7x works very well with the device. IS there a manual available specifically for this model? The Alpha miniRITE T manual supplied does seem fully applicable! An urgent reply requested as there is only one week left for the trial. Thank R. J. Mecoy

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Summary of Contents for Bernafon Encanta 400

  • Page 1 INSTRUCTIONS FOR USE Encanta IIC - CIC...

  • Page 2: Model Overview

    This booklet is valid for the following hearing aid models and styles: Styles Invisible-In-the-Canal  Completely-In-the-Canal  Battery Size 10 Bernafon Encanta 400 GTIN: (01) 05714464146710  Bernafon Encanta 300 GTIN: (01) 05714464146727  Bernafon Encanta 200 GTIN: (01) 05714464146734 ...

  • Page 4: Introduction To This Booklet

    Introduction to this booklet This booklet guides you on how to use and maintain your new hearing aids. Ensure you read the booklet carefully including the Warnings section. This will help you get the most benefit of your new hearing aid. Warnings Text marked with a warning symbol must be read before using the device.
  • Page 5 The education of the hearing care professional is in accordance with national or regional regulations. For your convenience this booklet contains a navigation bar to help you navigate easily through the different sections. About Getting started Daily use Options Tinnitus Warnings More info...

  • Page 6: Intended Use

    Intended use Intended use The hearing aid is intended to amplify and transmit sound to the ear. Indications for use Bilateral or unilateral impaired hearing of sensorineural, conductive, or mixed type ranging from a slight (16 dB HL*) to severe (75 dB HL*) degree of hearing loss, with an individual frequency configuration.
  • Page 7 IMPORTANT NOTICE The hearing aid amplification is uniquely adjusted and optimised to your personal hearing capabilities during the hearing aid fitting performed by your hearing care professional.

  • Page 8: Table Of Contents

    Table of contents About Your hearing aid Identify left and right hearing aid MultiTool for handling batteries and cleaning Getting started Turn the hearing aid ON and OFF Low battery indication How to replace the battery Daily use Insert the hearing aid Remove your hearing aid Caring for your hearing aid Filter replacement...
  • Page 9 Options Mute the hearing aid Optional features and accessories Tinnitus Tinnitus SoundSupport™ Guidelines for Tinnitus SoundSupport users Limitation on use time Sound options and volume adjustments Warnings related to Tinnitus Warnings General warnings More info Water & dust resistant (IP68) Conditions of use Technical information International warranty Your individual hearing aid settings...

  • Page 10: Your Hearing Aid

    Your hearing aid (CIC shown) What it is and does Microphone inlet Push-button Sound outlet Sound in (Optional - CIC only) Sound out Mute, change volume and program Battery drawer Contains the battery and functions as ON/OFF switch Pull out string Pull out the hearing aid Vent...

  • Page 11: Identify Left And Right Hearing Aid

    Identify left and right hearing aid It is important to distinguish between the left and the right hearing aid as they might be shaped and programmed differently. A BLUE shell, dot or text identifies the LEFT hearing aid A RED shell, dot or text identifies the RIGHT hearing aid...

  • Page 12: Multitool For Handling Batteries And Cleaning

    MultiTool for handling batteries and cleaning The MultiTool contains a magnet that makes it easier to replace the battery in the hearing aid. It also contains a brush and a wire loop for cleaning and removing earwax. If the vent is very small, a special tool may be required. If you need a new tool please contact your hearing care professional.

  • Page 14: Turn The Hearing Aid On And Off

    Turn the hearing aid ON and OFF The battery drawer is also used to switch the hearing aid ON and OFF. To save battery life, make sure your hearing aid is switched OFF when you are not wearing it. If you wish to return to the standard settings of the hearing aid, simply open and then close the battery drawer (quick reset).

  • Page 15: Low Battery Indication

    Low battery indication The low battery indication is repeated periodically until the battery runs out. Your hearing care professional can set your hearing aids to match your preferences. The battery is running low The battery has run out Three alternate tones Four descending tones Spoken indicators (Optional for select languages)

  • Page 16: How To Replace The Battery

    How to replace the battery 1. Remove 2. Uncover 3. Insert Fully open the battery Remove the sticky Insert the new battery label from the + side of drawer. Remove the into the battery drawer. battery. the new battery. Ensure that the + side of the battery and battery Tip: drawer align.
  • Page 17 4. Close MultiTool Close the battery drawer. The hearing The MultiTool can be used for battery aid will play a jingle. change. Use the magnetic end to Hold the hearing aid close to your ear remove and insert batteries. to hear the jingle.

  • Page 18: Insert The Hearing Aid

    Insert the hearing aid Step 1 Step 2 Place the tip of the hearing aid in your Gently pull your ear outwards and ear canal. push the hearing aid into the ear canal, twisting slightly if necessary. Follow the natural contour of the ear canal. Push the hearing aid to make sure it fits comfortably in the ear.

  • Page 19: Remove Your Hearing Aid

    Remove your hearing aid Hold the hearing aid by the pull-out string (if available). Gently pull the hearing aid from the ear canal. If your hearing aid doesn’t have a pull-out string, you can remove it by pulling on the edge of the hearing aid. IMPORTANT NOTICE DO NOT use the battery door as a handle to insert or remove your hearing aids, as it is not designed for this purpose.

  • Page 20: Caring For Your Hearing Aid

    Caring for your hearing aid When handling your hearing aid, hold it over a soft surface to avoid damage if you drop it. Cleaning the hearing aid Carefully brush away debris from the microphone inlets with a clean brush. Gently brush the surface. Make sure that the filters do not fall off. Microphone inlet About Getting started...
  • Page 21 Clean the vent by pressing the brush through the hole while twisting it slightly. If the vent is very small, a special tool may be required. Please consult your hearing care professional. Vent Vent IMPORTANT NOTICE To clean the hearing aids, use a soft, dry cloth. The hearing aids must never be washed or immersed in water or other liquids.

  • Page 22: Filter Replacement

    Filter replacement The filters keep wax and debris from damaging the hearing aid. If the filters become clogged, please replace the filters or contact your hearing care professional. • ProWax miniFit filters protect the sound outlet. • T-cap filters protect the microphone inlet. Please refer to the following pages for instructions on how to replace the appropriate filters.

  • Page 23: Replace Prowax Minifit Filter

    Replace ProWax miniFit filter 1. Tool 2. Remove 3. Insert filter filter New filter Old filter Old filter Remove the tool from Push the empty pin Insert the new ProWax the shell. The tool has into the ProWax miniFit miniFit filter using the two pins, one empty filter in the hearing aid other pin, remove the...

  • Page 24: Replace T-Cap Filter

    Replace T-Cap fi lter 1. Tool 2. Remove 3. Insert new fi lter Remove the tool from Push the tool fork Insert the new T-Cap the packaging. The tool under the top edge of fi lter and remove the has two ends, one for the used T-Cap fi lter tool by twisting it removal and one with...

  • Page 25: Change Volume With Push-Button

    Change volume with push-button (Optional - CIC only) The push-button allows you to adjust the volume. You may hear a click when you turn the volume up or down. MAXIMUM A short press on the RIGHT hearing aid START-UP increases the volume VOLUME A short press on the LEFT hearing aid...

  • Page 26: Change Programs

    Change programs (Optional - CIC only) Your hearing aid can have up to four different programs. These are programmed by your hearing care professional. You will hear one to four tones when you change program depending on the program. Use a short press to switch between programs. If Volume control is enabled, use a long press to switch programs.
  • Page 27 For information regarding tones, see the Sound indicators section. For information regarding button press times see the table General settings overview for your hearing aid, in the Your individual hearing aid settings section at the end of this booklet.

  • Page 28: Options

    Mute the hearing aid Use the mute function if you need to silence the hearing aid. Only available for hearing aids with push-button. Press and hold the push-button for two seconds to mute the hearing aid. To unmute, press the push-button.

  • Page 29: Optional Features And Accessories

    Optional features and accessories The features and accessories described on the following pages are optional. Please contact your hearing care professional to find out how your hearing aid is programmed. If you experience difficult listening situations, a special program may be helpful.

  • Page 30: Tinnitus Soundsupport

    Tinnitus SoundSupport™ (Optional - CIC only) Intended use of Tinnitus SoundSupport Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief for patients suffering from tinnitus as part of a tinnitus management program. The target population is the adult population (over 18 years of age). Tinnitus SoundSupport is targeted to licenced hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing loss.

  • Page 31: Guidelines For Tinnitus Soundsupport Users

    Guidelines for Tinnitus SoundSupport users Your hearing care professional will be able to offer the appropriate follow- up care. It is important to follow his/her advice and directions regarding such care. Limitation on use time Daily use The volume levels of Tinnitus SoundSupport can be set to a level which could lead to permanent hearing damage when used for a prolonged period of time.

  • Page 32: Sound Options And Volume Adjustments

    Sound options and volume adjustments Tinnitus SoundSupport is programmed by your hearing care professional to match your hearing loss and preferences for tinnitus relief. Tinnitus SoundSupport programs The sound generator can be activated in up to four different programs. Mute If you are in a program for which Tinnitus SoundSupport is activated, the mute functionality only mutes the environmental sounds, and not the sound from Tinnitus SoundSupport.
  • Page 33 Volume adjustments with Tinnitus SoundSupport Your hearing care professional can set the volume control for a hearing aid program for which Tinnitus SoundSupport is activated. For more information about volume adjustments with Tinnitus SoundSupport, see the table Tinnitus SoundSupport settings overview for your hearing aid in the Your individual hearing aid settings section at the end of this booklet.

  • Page 34: Warnings Related To Tinnitus

    Warnings related to Tinnitus If your hearing care professional As with any device, misuse of the sound has activated the sound generator generator feature may cause potentially Tinnitus SoundSupport, please pay harmful effects. Care should be taken to attention to the following warnings. prevent unauthorised use and to keep the device out of reach of children and pets.

  • Page 35: General Warnings

    General warnings For your personal safety and to ensure To achieve the full benefit from your correct usage, you should familiarise hearing aids, you should use them frequently. yourself fully with the following general warnings before using your hearing aids. Usage of hearing aids Consult your hearing care professional Hearing aids should only be used as...
  • Page 36 General warnings Risk of placing batteries in ear or nose Beware of sudden dysfunction Never place batteries in the ear or the Your hearing aids may stop working nose. This can lead to permanent without notice. For example, if they run out of battery or if the tubing is blocked.
  • Page 37 Accessories with built-in magnets (for Keep away from extreme heat example the Autophone magnet and Never expose your hearing aids to extreme the MultiTool) should be kept at least heat. For example, do not leave your 30 centimetres (12 inches) away from hearing aids inside a parked car in the sun.
  • Page 38 General warnings Potential side effects may result in reduced electromagnetic You may produce more earwax when using compatibility (EMC) of your hearing aid. hearing aids. Do not modify In rare cases, the non-allergenic materials Do not make any modifications to your in the product may cause skin irritation or hearing aid not expressly approved by the other side effects.

  • Page 39: Water & Dust Resistant (Ip68)

    Water & dust resistant (IP68) Your hearing aid is dust-tight and protected against ingress of water which means it is designed to be worn in all daily life situations. Therefore, you do not have to worry about humidity or getting wet in the rain.

  • Page 40: Conditions Of Use

    Conditions of use Operating Conditions Temperature: +1°C to +40°C (34°F to 104°F) Humidity: 5% - 93% relative humidity, non-condensing Atmospheric pressure: 700 hPa to 1060 hPa Transportation and Temperature and humidity shall not exceed the below storage conditions limits for extended periods during transportation and storage: Temperature: -25°C to + 60°C (-13°F to 140°F) Humidity: 5% - 93% relative humidity, non-condensing...

  • Page 41: Technical Information

    Technical information The hearing aids contain a radio Radiated emissions requirements for a transceiver using short range magnetic CISPR 11 Group 1 Class B device as stated induction technology operating at in table 2 of IEC 60601-1-2. 3.84 MHz. The magnetic field strength of the transmitter is very weak and always Radiated emission for communication below 15 nW (typically below –15 dBμA/m...
  • Page 42 Additional fields at 30 kHz, 134.2 kHz and 13.56 MHz information can be found in the Technical as stated in table 11 of IEC 60601-1-2 data document on www.bernafon.com AM1. RF radiated immunity field levels at selected bands stated in IEC 60118-13 between 25 V/m and 60 V/m and, for...
  • Page 43 Declaration of Conformity is available at hearing aid is in compliance with the the headquarters. essential requirements and other relevant provisions of Directive 2014/53/EU. Bernafon Kongebakken 9 This medical device complies with Medical DK-2765 Smørum Device Regulation (EU) 2017/745. Denmark www.bernafon.com/doc...
  • Page 44 Description of symbols accompanying the product Warnings Text marked with a warning symbol must be read before using the device. Manufacturer The device is produced by the manufacturer whose name and address are stated next to the symbol. Indicates the medical device manufacturer, as defined in EU Regulation 2017/745.
  • Page 45 Description of symbols accompanying the product Radio Frequency (RF) transmitter Your device contains an RF transmitter. Global Trade Item Number A globally unique 14-digit number used to identify medical device products including GTIN medical device software. GTIN in this booklet is related to medical device firmware (FW). GTIN on regulatory packaging label is related to medical device hardware.

  • Page 46: International Warranty

    International warranty Your device is covered by an international may also have issued a warranty that goes warranty issued by the manufacturer. beyond the clauses of this international This international warranty covers warranty. Please consult him/her for manufacturing and material defects in the further information.

  • Page 48: Your Individual Hearing Aid Settings

    Your individual hearing aid settings To be filled out by your hearing care professional. Tinnitus SoundSupport: Limitation on use No limitation on use Program Start-up volume (Tinnitus) Max volume (Tinnitus) Max _______ hours per day Max _______ hours per day Max _______ hours per day Max _______ hours per day Max _______ hours per day Max _______ hours per day...
  • Page 49 Tinnitus SoundSupport settings overview for your hearing aid Left Right Tinnitus SoundSupport A) How to change Tinnitus SoundSupport volume in each ear separately To increase or decrease the volume (on one hearing aid only), use a short press on the push-button repeatedly until you reach your desired level. B) How to change Tinnitus SoundSupport volume in both ears simultaneously You can use one hearing aid to increase the volume and the other hearing aid...

  • Page 50: Sound Indicators

    Sound indicators Different sounds indicate the hearing aid status. The different indicators are listed below. Your hearing care professional can set sound indicators to match your preferences. Program Sound Spoken indicators When to use 1 tone 2 tones 3 tones 4 tones About Getting started Daily use Options Tinnitus Warnings More info...
  • Page 51 General settings overview for your hearing aid Left Right Short press Short press Change program Long press Long press Change volume Volume control indicators Beeps at min/max volume Beeps when changing volume Beeps at start-up volume Battery indicators Low battery warning To be filled out by your hearing care professional.

  • Page 52: Troubleshooting Guide

    Troubleshooting guide Symptom Possible causes Worn-out battery Clogged sound outlet No sound Clogged microphone inlet Hearing aid microphone muted Clogged sound outlet Intermittent or Moisture reduced sound Worn-out battery Hearing aid not inserted properly Squealing noise Ear wax accumulated in ear canal Service alert voice Issue detected by hearing aid...
  • Page 53 Solutions Replace the battery Clean sound outlet* or replace the wax filter Clean microphone inlet* or replace filter (T-Cap) Unmute the hearing aid microphone Clean sound outlet or replace the wax filter Wipe battery and hearing aid with a dry cloth Replace the battery Re-insert the hearing aid Have ear canal examined by your doctor...
  • Page 55 < > 8,15 mm Placeholder for FSC logo < 15 mm >...
  • Page 56 0000275504000001...

This manual is also suitable for:

Encanta 300Encanta 200Encanta 100