Bernafon Entra B 20 Instructions For Use Manual

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INSTRUCTIONS FOR USE

Entra B

IIC - CIC - ITC - ITE HS - ITE FS

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Page 1 INSTRUCTIONS FOR USE Entra B IIC - CIC - ITC - ITE HS - ITE FS...
Page 2: 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 this booklet carefully, including the Warnings section. This will help you get the most benefit from your hearing aids. Warnings Text marked with a warning symbol must be read before using the device.
Page 3: Model Overview
Model overview This booklet is valid for the following hearing aid models, battery sizes, and styles: FW 1.0 Bernafon Entra B 20 GTIN: (01) 05714464150229  Bernafon Entra B 10 GTIN: (01) 05714464150236  Battery size   Bluetooth® ...
Page 4: 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 (25 dB HL*) to severe (86 dB HL*) degree of hearing loss, with an individual frequency configuration.
Page 5 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 6: Table Of Contents
Table of contents About Identify your hearing aid Hearing aids with size 10 battery Hearing aids with size 312 battery Identify left and right hearing aid MultiTool for handling batteries and cleaning Getting started Turn the hearing aid ON and OFF Replace the battery How to replace the battery Daily use...
Page 7 Change programs Change volume with push-button Change volume with volume wheel Options Mute the hearing aid Turn Bluetooth ON/OFF Use your hearing aids with digital devices Pairing and compatibility Wireless accessories Other options 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...
Page 8 Table of contents Warnings General warnings More info Water & dust resistant (IP68) Conditions of use Technical information International warranty Warranty Your individual hearing aid settings Troubleshooting guide...
Page 9: Identify Your Hearing Aid
Identify your hearing aid For your in-the-ear hearing aid, there are several different styles available with different battery sizes. Please see the model overview for your style and battery size. This will make it easier for you to navigate through this booklet.
Page 10: Hearing Aids With Size 10 Battery
Hearing aids with size 10 battery (CIC shown) What it is and does Microphone inlet Push-button Sound outlet Sound in (optional) 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: Hearing Aids With Size 312 Battery
Hearing aids with size 312 battery (ITC shown) What it is and does Push-button Volume wheel Sound outlet (optional) (optional) Sound out Mute, change Change volume volume and program Battery drawer Contains the battery and functions as ON/OFF switch Microphone inlet Vent Sound in Vent...
Page 12: 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 About Getting started Daily use Options Tinnitus Warnings More info...
Page 13: 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: Replace The Battery
Replace the battery When it is time to replace the battery, you will hear three beeps repeated at moderate intervals until the battery runs out. Three beeps* Four beeps = The battery is running low = The battery has run out Battery tip To make sure the hearing aid is always working, bring spare batteries with you, or replace the battery before you leave home.
Page 16: Daily Use
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 inlets 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 filter protects the sound outlet. • O-cap and T-cap 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 filter (hearing aids with size 10 battery) 1. Tool 2. Remove 3. Insert new filter Remove the tool from Push the tool fork Insert the new T-Cap the packaging. The tool under the top edge of filter and remove the has two ends, one for the used T-Cap filter tool by twisting it...
Page 25: Replace O-Cap Filter
Replace O-Cap filter (hearing aids with size 312 batteries) 1. Tool 2. Remove 3. Insert new filter Remove the tool from Push the pointed end Insert the new O-Cap the packaging. The tool of the tool into the filter using the other end has two ends, one for existing O-Cap filter of the tool and remove.
Page 26: Change Programs
Change programs 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 To be filled out by the hearing care professional Program Sound you will hear When to use when activated “1 beep” “2 beeps” “3 beeps” “4 beeps” Program change: Independent Synchronised LEFT RIGHT Short press Long press...
Page 28: Change Volume With Push-Button
Change volume with push-button 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 decreases the volume MINIMUM...
Page 29: Change Volume With Volume Wheel
Change volume with volume wheel The volume wheel allows you to adjust the volume. You may hear a click when you turn the volume up or down. Down Turn forward to turn up the volume Turn backwards to turn down the volume...
Page 30: 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 31: Turn Bluetooth On/Off
Turn Bluetooth ON/OFF Bluetooth connectivity can be turned ON/OFF on your hearing aids. When Bluetooth is turned OFF the hearing aids are still turned ON and functioning. Be aware that pressing the push-button on one hearing aid, turns OFF bluetooth for both hearing aids. Your hearing aids use Bluetooth wireless technology.
Page 32: Use Your Hearing Aids With Digital Devices
Your hearing aids support Audio Streaming for Hearing Aids (ASHA) and allow for direct streaming from selected Android™ devices.* Bernafon App can be used to control your hearing aids from your mobile device.* For assistance in using your hearing aids with any of these products, contact your hearing care professional.
Page 33: Pairing And Compatibility
For instructions on how to pair your hearing aids with iPhone, iPad or Android devices, visit: www.bernafon.com/support/pairing For a list of compatible iPhone, iPad and Android devices, visit: www.bernafon.com/compatibility For instructions on pairing your hearing aids to Mac and a list of compatible devices, visit: www.bernafon.com/support/pairing...
Page 34: Wireless Accessories
Bernafon App TV-A An application that lets you control Wireless transmitter of sound your hearing aid from your mobile from TV and electronic audio phone or tablet.
Page 36: Other Options
Other options Telecoil - optional for select styles Telecoil helps you hear better when using a telephone with a built- in loop or when you are in buildings with teleloop systems such as theatres, churches, or lecture rooms. This symbol or a similar sign is shown wherever a teleloop has been installed.
Page 37: 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 38: Tinnitus Soundsupport
Tinnitus SoundSupport™ (Optional) 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 39: 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 40: 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 41 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 42: 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 43 Change volume with push-button See section Change volume with push-button for illustration A) How to change Tinnitus SoundSupport volume in each ear separately To increase volume (on one hearing aid only), use a short press on the push-button repeatedly until desired level is reached. The sound will always be louder with the first press(es) until two beeps are heard.
Page 44 Change volume with volume wheel See section Change volume with volume wheel for illustration A) How to change Tinnitus SoundSupport volume in each ear separately To increase volume (on one hearing aid only), turn the volume wheel forward. To decrease volume (on one hearing aid only), turn the volume wheel backwards.
Page 45 If your hearing aid has Bluetooth connection, you will be able to adjust the environmental sounds in a program with Tinnitus SoundSupport with RC-A or SoundClip-A. Bernafon App for iPhone, iPad and Android™ devices offers the possibility to adjust both the environmental sound and the Tinnitus SoundSupport in each program directly from the app.
Page 46: 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 yourself fully with the following general frequently. warnings before using your hearing aids. Usage of hearing aids Consult your hearing care professional Hearing aids should only be used as...
Page 47 Fatality hazards of swallowing batteries that the batteries will explode. Follow local Never swallow batteries. Doing so can lead guidelines for proper and safe disposal of batteries to serious injury or death within hours. Swallowed batteries can cause burns that Beware of sudden dysfunction may perforate inner organs.
Page 48 General warnings implants, such as pacemakers and heart Keep away from extreme heat defibrillators. Never expose your hearing aids to extreme heat. For example, do not leave your Accessories with built-in magnets (for hearing aids inside a parked car in the sun. example the Autophone magnet and the MultiTool) should be kept at least Never use an external heating device to dry...
Page 49 be a risk of impairing the remaining hearing Use of third-party accessories of the hearing aid user. For information Only use accessories, cables or transducers on whether your instrument is a power (for example, microphones) supplied by hearing aid, see the model overview the manufacturer.
Page 50: 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 51: 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 52: 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 53 Additional selected bands stated in IEC 60118-13 information can be found in the Technical between 25 V/m and 60 V/m and, for data document on www.bernafon.com proximity-fields from communication devices held to the ear, stated in ANSI C63.19.
Page 54 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 55 Apple, the Apple logo, iPhone, iPad, and Apple is not responsible for the operation Mac and the Mac logo are trademarks of of this device or its compliance with safety Apple Inc., registered in the U.S. and other and regulatory standards. countries.
Page 56 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 57 Description of symbols accompanying the product Made for Apple badges Indicates that the device is compatible with iPhone and iPad. Mac badge Indicates that the device is compatible with Mac. Apple AirPlay badge The AirPlay button can be used to disconnect and connect hearing aids from a Mac. Android badge Indicates that the device is compatible with Android.
Page 58 Description of symbols accompanying the product Catalogue number Indicates the manufacturer’s catalogue number so that the medical device can be identified. Serial number Indicates the manufacturer’s serial number so that a specific medical device can be identified. Medical Device The device is a medical device. Unique device identifier Indicates a carrier that contains unique device identifier information.
Page 59: 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 60: Warranty
Warranty Certificate Name of owner: __________________________________________________________ Hearing care professional: __________________________________________________ Hearing care professional’s address: __________________________________________ Hearing care professional’s phone: ___________________________________________ Purchase date: ___________________________________________________________ Warranty period: ________________ Month: __________________________________ Model left: _____________________ Serial no.: ________________________________ Model right: ____________________ Serial no.: ________________________________ Battery size: ____________________________________________________________ About Getting started Daily use Options Tinnitus Warnings More info...
Page 61: 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 62 Power instrument Settings overview for your hearing aid Left Right Volume control Program shift Mute Tinnitus SoundSupport Volume control indicators Beeps at min/max volume Clicks when changing volume Beeps at preferred volume Battery indicators Low battery warning About Getting started Daily use Options Tinnitus Warnings More info...
Page 64: 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 Pairing issue Bluetooth connection failed with Apple...
Page 65 1) Unpair your hearing aid. 2) Turn Bluetooth off and on again. 3) Open and close battery drawer on hearing aid. 4) Re-pair hearing aid (for guidance, visit: www.bernafon.com/support/pairing/) If none of the above solutions work, consult your hearing care professional for assistance.
Page 67 < > 8,15 mm Placeholder for FSC logo < 15 mm >...
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