Bernafon Viron 3-1 miniRITE T R Instructions for use
Bernafon Viron 3-1 miniRITE T R hearing aids are designed to amplify and transmit sound to the ear, improving speech understanding and easing communication. With a range of acoustic options, including 60, 85, 100, and 105 speakers, these hearing aids can be tailored to your specific hearing needs. The rechargeable battery provides up to 24 hours of use on a single charge, and the low battery indicator ensures you're always aware of the battery level. The hearing aids are also water and dust resistant (IP68), making them suitable for various environments.
Διαφήμιση
Διαφήμιση
miniRITE T R
Receiver-in-the-Ear Hearing Aids
Viron
Instructions for Use
Introduction to this booklet
This booklet shows you how to use and maintain your new hearing aid. Please read the booklet carefully including the warning sections. This will help you to get the most out of your new hearing aid.
Your hearing care professional has adjusted the hearing aid to meet your needs. If you have further questions, please contact your hearing care professional.
3
4
Model overview
This booklet is valid for the following hearing aid families and models:
Viron FW4
Viron 9 – VN9 MNR T R
GTIN: (01)05711584106501
Viron 7 – VN7 MNR T R
GTIN: (01)05711584106495
Viron 5 – VN5 MNR T R
GTIN: (01)05711584106488
Viron 3 – VN3 MNR T R
GTIN: (01)05711584115916
Viron 1 – VN1 MNR T R
GTIN: (01)05711584115923
The following acoustic options are available for the above families:
60-Speaker
85-Speaker
100-Speaker (power instrument)
100-Speaker with Power Mold (power instrument)
105-Speaker with Power Mold (power instrument)
Intended use
Intended use
The hearing aid is intended to amplify and transmit sound to the ear
Indications for use
Impaired hearing within mild to severe-to-profound hearing loss
Intended user
Adults and children older than 36 months
Use environment
Indoor and outdoor
Contraindications
Users of active implants must pay special attention when using the hearing aid. For more information read the Warnings section.
Clinical benefits
The hearing aid is designed to provide better speech understanding to help ease communication with the aim of improving quality of life
Important notice
The hearing aid amplification is uniquely adjusted and optimized to your hearing capabilities during the hearing aid fitting performed by your hearing care professional.
5
6
In short
Charging
Charge the hearing aid every night.
The LED on the hearing aid will turn RED/ORANGE when the hearing aid is charging and GREEN when fully charged.
It takes 3 hours to fully charge the hearing aid.
ON/OFF
·
The hearing aid turns ON when you remove it from the charger.
·
The hearing aid turns OFF when you place it in the charger.
Always leave the charger connected to a power supply when the hearing aid is seated in the charging port. Unplugging the charger will make the hearing aid turn on and start using the battery.
Table of contents
Identify your hearing aid, speaker, and earpiece
Your hearing aid − What it is and does
Charging the hearing aids
Charging time
Battery performance
Turn hearing aid ON/OFF using charger
10
13
14
15
16
17
Turn hearing aid ON/OFF using push button 18
Low battery indication
Identify left and right hearing aid
19
20
Put on the hearing aid 21
Cleaning 22
Replacing standard earpieces
ProWax miniFit filter
24
25
Replace ProWax miniFit filter
Clean customized earpieces
Replace ProWax filter
26
27
28
7
8
Store the hearing aid
Flight mode
Optional features and accessories
Change volume (optional)
Change program (optional)
Mute the hearing aid (optional)
Put hearing aid in pairing mode
Using hearing aid with iPhone, iPad, or iPod touch
Pairing hearing aid with iPhone
37
38
Re-connect your hearing aids to your iPhone, iPad, or iPod touch 41
33
35
36
29
30
31
32
Wireless accessories (optional)
Other options (optional)
Sound and LED indications
Tinnitus SoundSupport (optional)
Guidelines for tinnitus sound generator users
Sound options and volume adjustment
Limitation on use time
42
43
44
47
48
49
51
Important information for hearing care professionals about Tinnitus SoundSupport 52
Warnings related to Tinnitus SoundSupport 54
General warnings 55
Troubleshooting guide
Water & dust resistance (IP68)
Conditions of use
Warranty certificate
64
68
69
70
International warranty
Technical information
Your individual hearing aid settings
71
72
74
9
Identify your hearing aid, speaker, and earpiece
Ear grip (optional)
10
Speaker
(60-Speaker shown)
Speakers
miniRITE T R hearing aid comes with five different speakers:
Standard speakers
60-Speaker 85-Speaker 100-Speaker
Power Mold speakers
100-Speaker
105-Speaker
The standard speakers use one of the following earpieces:
Standard earpieces
Open Dome
Bass Dome, single vent
Bass Dome, double vent
Power Dome
Grip Tip*
(available in small and large, left and right, with or without vent)
* Please see details for replacing the dome or Grip Tip in section: “Replacing standard earpieces”.
Dome sizes
5 mm* 6 mm 8 mm 10 mm
* only as Open Dome for 60-Speaker
** not for Open Dome
12 mm**
11
12
Customized earpieces
Micro Mold
Lite Tip
VarioTherm
®
Micro Mold
VarioTherm
®
Lite Tip
VarioTherm
®
is a registered trademark of Dreve.
Your hearing aid − What it is and does
LED light
Charging, ON,
OFF, flight mode status
Microphones
Sound in
Ear grip
Holds the speaker in place (optional)
Wax filter
Protect the speaker from wax
Push button
Upper part:
Volume up, program change.
Lower part:
ON, OFF, flight mode, volume down, program change
Rechargeable battery
Only replaced by the hearing care professional
Speaker
Sound out
13
Start up
Start up
Charging the hearing aids
Place hearing aids in charger
Charging
Place the hearing aids in the charging ports as shown in the picture.
The LEDs on the hearing aids will turn on when the hearing aids are correctly placed in the charger.
Hearing aid LED charging status:
Red/orange light = Charging
Green light = Fully charged
14
Charging time
Fully charge your hearing aid at least 3 hours before first time use.
Charge your hearing aid every night. That ensures that you will start your day with a fully charged hearing aid.
Charging time can vary depending on the remaining capacity of the battery. If your hearing aid is completely drained, the normal charging time is:
3 hours = Fully charged
1 hour = 50 % charged
0.5 hours = 25 % charged
The charging process will automatically stop when the battery is fully charged. Leave the hearing aid in the charger when you do not use it. Remember to keep the charger connected to a power source.
Note that charging time may vary between the left and the right hearing aid.
15
16
Battery performance
The daily battery performance varies depending on your individual use and hearing aid settings.
Streaming sound from a TV, mobile phone or
SoundClip-A can influence daily battery performance.
If your hearing aid runs out of battery, place it in the charger for a recharge. Additional usage time cannot be achieved by trying to restart the hearing aid.
For the best charging conditions, the room temperature should be between +5 °C to +35 °C.
If you experience that your hearing aid does not perform for a full day, it might be time to have the battery replaced. Contact your hearing care professional.
Turn hearing aid ON/OFF using charger
Your hearing aid automatically turns
ON
when removed from the charger.
The hearing aid LED turns GREEN after 6 seconds, confirming that it is ready for use. You may hear a start-up jingle.
Your hearing aid automatically turns
OFF
when placed in the charger and starts charging. The LED turns
RED/ORANGE.
Important notice
Always leave the charger connected to a power source when the hearing aid is seated in the charging port. Unplugging the charger will make the hearing aid turn on and start using the battery.
17
18
Turn hearing aid ON/OFF using push button
The hearing aid can be turned ON and OFF using the push button.
ON:
Press and hold the lower part of the button for approx. 2 seconds.
Release the button and wait until the hearing aid LED turns GREEN.
The hearing aid is now turned ON.
You may hear a short start-up jingle.
OFF:
Press and hold the lower part of the button for approx. 3 seconds until the hearing aid LED turns RED/ORANGE and the hearing aid plays 4 descending tones. Release the push button and the hearing aid is turned OFF.
See overview “Sound and LED indications”.
Low battery indication
When the battery is running low, you will hear
3 short beeps. This will leave you approximately
2 hours before the hearing aid stops working. The beeps will be repeated every 30 minutes. Just before the battery runs out you will hear 4 descending tones.
If you are streaming audio to your hearing aid (e.g., from TV or mobile phone), you have approximately
1 hour before the hearing aid stops working, when you hear the 3 short beeps.
Stopping streaming will prolong the battery performance.
Three beeps
The battery is running low
Four beeps
The battery has run out
Optional LED
The LED blinks red/orange and continuously repeats to indicate that the battery is low.
19
20
Identify left and right hearing aid
It is important to distinguish between the left and the right hearing aid, as they might be programmed differently.
You can find left/right color indicators on the hearing aid itself and on 60- and 85-Speakers as shown.
Indicators (either L or R) can also be found on
100-Speakers and some earpieces.
A
RED
indicator marks the RIGHT hearing aid
A
BLUE
indicator marks the LEFT hearing aid
Put on the hearing aid
The speaker brings the sound into your ear. The speaker should always be used with an earpiece attached. Use only parts designed for your hearing aid.
If the speaker has an ear grip, place it in the ear so it follows the contour of the ear (see step 3).
Step 1
Place the hearing aid behind your ear.
Step 2
Hold the bend of the speaker wire between your thumb and index finger. The earpiece should point towards the ear canal opening.
Step 3
Gently push the earpiece into your ear canal until the speaker wire sits close against the side of your head.
21
Cleaning
The MultiTool contains a brush and a wire loop for cleaning and removing ear wax from your earpiece.
If you need a new MultiTool, please contact your hearing care professional.
Magnet
Brush
Wire loop
22
Important notice
The MultiTool has a built-in magnet. Keep the
MultiTool at least 30 cm away from credit cards and other magnetically sensitive devices.
When handling your hearing aid, hold it over a soft surface to avoid damage if you drop it.
Clean the microphone openings
Carefully brush away debris from the openings using a clean brush. Gently brush the surface and make sure the brush is clean and that it is not pressed into the openings.
Microphone openings
Wax filter
Important notice
Use a soft, dry cloth to clean the hearing aid.
It must never be washed or immersed in water or other liquids.
23
Replacing standard earpieces
The standard earpiece (dome and Grip Tip) should not be cleaned. If the earpiece is filled with wax, replace it with a new one. Grip Tip needs to be replaced at least once a month.
Step 1
Hold on to the end of the speaker and then pull off the earpiece.
Step 2
Insert the speaker exactly into the middle of the earpiece to obtain a firm attachment.
Step 3
Push firmly to ensure that the earpiece is fastened securely.
24
Important notice
If the earpiece is not on the speaker when removed from the ear, the earpiece may still be in the ear canal. Consult your hearing care professional for further instructions.
ProWax miniFit filter
The speaker has a white wax filter attached to the end where the earpiece is attached. The wax filter will help prevent wax and debris from damaging the speaker. If the filter becomes clogged, please replace the wax filter (see section “Replace ProWax miniFit filter”) or contact your hearing care professional.
Remove the earpiece from the speaker before replacing the wax filter.
Important notice
Always use the same type of wax filter as was originally supplied with the hearing aid. If you are in any doubt about the use or replacement of wax filters, contact your hearing care professional.
25
26
Replace ProWax miniFit filter
1. Tool
Remove the tool from the shell. The tool has two pins, one empty for removal and one with the new wax filter.
2. Remove
Push the empty pin into the wax filter in the speaker and pull it out.
New filter
Empty pin
3. Insert
Insert the new wax filter using the other pin, remove the tool and throw it out.
New filter
Old filter
4. Final
The speaker should look as shown when you have replaced the wax filter.
✻
If you use a mold or LiteTip, a hearing care professional must replace the wax filter in the speaker.
Clean customized earpieces
The earpiece should be cleaned regularly. The earpiece contains a wax filter*. The filter keeps wax and debris from damaging the speaker. Replace the filter when clogged or when the hearing aid does not sound normal. Alternatively, contact your hearing care professional.
Always use the wax filter delivered by your hearing care professional.
The vent is cleaned by pressing the brush through the hole, twisting it slightly.
Vent
ProWax filter
* VarioTherm Micro Mold and LiteTip do not have a wax filter.
27
28
Replace ProWax filter
1. Tool
Remove the tool from the shell. The tool has two pins, one empty for removal and one with the new wax filter.
2. Remove
Push the empty pin into the wax filter in the mold and pull it out.
New filter
New filter
3. Insert
Insert the new wax filter using the other pin, remove the tool, and throw it out.
Old filter
Store the hearing aid
The charger is the optimal storage for the hearing aid. Anytime your hearing aid is not in use, place it in the charger for charging. This will ensure your hearing aid is always charged.
To ensure the longest life of the rechargeable battery in the hearing aid, do not expose it to excess heat.
For example, do not leave the hearing aid in the sun in a window or in a car, even if the hearing aid is in the charger.
Long term storage (weeks, months)
Before storing the hearing aid for a longer period
(more than 14 days) fully charge the hearing aid.
Then turn the hearing aid off. This way the battery can be charged again.
It is necessary to fully charge the hearing aid every
6 months to protect the rechargeable battery. If a stored hearing aid is not charged within a 6-month time frame, the rechargeable battery will need to be replaced.
Important notice
Always leave the charger connected to a power source when the hearing aid is seated in the charging port. Unplugging the charger will make the hearing aid turn on and start using the battery.
29
30
Flight mode
When boarding an airplane or entering an area where it is prohibited to radiate radio signals, e.g., during flight, flight mode must be activated. It is only necessary to activate flight mode on one hearing aid.
When flight mode is activated, only Bluetooth
®
is turned off. The hearing aid will still be working.
To activate and deactivate flight mode press and hold the push button (lower part) for 7 seconds.
Beep:
The hearing aid plays
4 descending tones followed by
4 tones to indicate that flight mode is activated or deactivated.
LED flight mode activated:
A long red/orange blink followed by green, red/orange, red/ orange. The LED will blink green, red/orange, red/orange a few times. This confirms that flight mode is activated.
LED flight mode deactivated:
The LED will turn steady red/orange for a few seconds, until the hearing aid returns to its normal operating mode.
Pressing the button on one hearing aid will activate flight mode on both hearing aids.
See overview “Sound and LED indications”.
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. These are programmed by your hearing care professional.
Write down hearing situations where you may need help.
31
Change volume (optional)
The push button allows you to adjust the volume.
You will hear a beep when you turn the volume up or down.
Give a short press to the button to increase the volume
Give a short press to the button to decrease the volume
Maximum
Start-up level
You will hear 2 beeps at the start-up level.
You will hear 3 beeps at
Maximum and Minimum.
32
Minimum
Volume Change
Left Right
To be filled out by the hearing care professional.
Change program (optional)
Your hearing aid can have up to 4 different programs.
These are programmed by your hearing care professional.
Press up or down to change between programs
✼
You can change continuously between programs both up and down in the program order. For example, if you want to go from program 1 to 4, you can press the down button once instead of pressing the up button 3 times.
33
34
To be filled out by the hearing care professional
Program Activation sound When to use
Program 1 1 tone
Program 2
Program 3
Program 4
2 tones
3 tones
4 tones
Green, short blink
Program change:
Left Right Short press Medium press
Mute the hearing aid (optional)
Use the mute function if you need to silence the hearing aid while wearing it.
Your hearing aid can be muted by using one of the following optional devices:
·
·
Bernafon EasyControl-A app
SoundClip-A
·
RC-A remote control
The LED might blink red/orange and green, depending on how your hearing care professional has configured your hearing aid.
How to unmute your hearing aid
The hearing aid can be unmuted using one of the optional devices or by applying a short press to any of the buttons on the hearing aid.
Important notice
Do not use the mute function as an off switch, as the hearing aid still draws current from the battery in this mode.
35
36
Put hearing aid in pairing mode
To pair your hearing aid with a wireless accessory
(e.g. TV-A, SoundClip-A, smartphone, etc.), your hearing aid must be in pairing mode. To activate pairing mode, switch the hearing aid OFF and ON as described on pages 17 and 18.
The hearing aid will remain in pairing mode for
180 seconds.
Using hearing aid with iPhone, iPad, or iPod touch
Your hearing aid is a Made for iPhone
®
hearing aid and allows for direct communication and control with an iPhone
®
, iPad
®
, or iPod
®
touch.
For assistance in pairing and using these products with your hearing aid, please contact your hearing care professional or visit our support site at: www.bernafon.com/library.
For information on compatibility, please visit www.bernafon.com/products/accessories.
✼
Direct audio streaming is currently not supported by
Android™.
37
38
Pairing hearing aid with iPhone
2. Accessibility 1. Settings
Bluetooth
On
MFi Hearing Devices
Accessibility
Open your iPhone and go to “Settings”.
Make sure Bluetooth
®
is on. Then choose
“Accessibility”.
On the “Accessibility” screen, choose
“MFi Hearing Devices”.
3. Prepare
Pairing must occur within 3 minutes after the hearing aid is turned on.
To restart the hearing aid, place it in the charger and remove it again, or use the push button (see section:
Turn ON/OFF using push button). This will put the hearing aid into pairing mode.
4. Select
Andrea’s Hearing Devices
Bernafon Viron 9
Your iPhone will detect the hearing aid for pairing. Detected devices will appear in your iPhone list. Choose your hearing aid.
39
40
5. Confirm pairing
Bluetooth Pairing Request
Bernafon Viron would like to pair with your iPhone
Cancel Pair
Confirm pairing.
If you have two hearing aids, pairing confirmation is needed for each hearing aid.
Re-connect your hearing aids to your iPhone, iPad, or iPod touch
When you turn off your hearing aids or iPhone, iPad, or iPod touch, these will no longer be connected. To connect them again, restart your hearing aids. The hearing aids will then automatically reconnect to your iPhone, iPad, or iPod touch.
Use of the Made for Apple badge means that an accessory has been designed to connect specifically to the Apple product(s) identified in the badge, and has been certified by the developer to meet Apple performance standards. Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards.
Please note that use of this Accessory with iPod, iPhone, or iPad may affect wireless performance. Apple, the
Apple logo, iPhone, iPad, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.
41
42
Wireless accessories (optional)
As an enhancement to your wireless hearing aid, a range of wireless accessories are available. They can enable you to hear and communicate better in a lot of everyday situations.
SoundClip-A
When this device is paired with your mobile phone, you can use the hearing aids like stereo headphones.
SoundClip-A can also function as a remote microphone and remote control.
TV-A
TV-A is a wireless transmitter of sound from TV and electronic audio devices. The TV-A streams sound directly to your hearing aid.
RC-A
RC-A remote control offers the ability to change programs, adjust volume or mute your hearing aid.
Bernafon EasyControl-A app
The app offers an intuitive and discreet way to control your hearing aids with iPhone, iPad, iPod touch, and
Android devices.
For more information, please contact your hearing care professional or visit: www.bernafon.com/products/accessories.
Other options (optional)
Telecoil
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 theaters, churches, or lecture rooms. This symbol or a similar sign is shown wherever a teleloop has been installed.
For more information, please contact your hearing care professional.
43
44
Sound and LED indications
Different sound and light indications help to show the hearing aid status. The different settings are listed on the following pages.
Your hearing care professional can set sound and
LED indications to match your preferences.
For charger LED indication, see Charger Instruction for Use.
Status Indicators
Start-up
Shutdown
Flight mode activation
Sound
Start-up jingle
4 descending tones
Shutdown tones followed by 4 tones
LED
Warning Indicators Sound
Battery low indication 3 beeps
LED
4 descending tones – Battery end of life
Microphone service check needed
System error
8 beeps
–
Green, short blink
Red/orange, short blink
Green, long blink
Red/orange, long blink
45
46
Program Indicators
Program 1
Program 2
Program 3
Program 4
TV Adapter program
Remote Mic program
Sound
1 tone
2 tones
3 tones
4 tones
2 ascending tones
2 descending tones
LED
Volume Indicators
Preferred volume
Min/max volume
Volume change
Mute activated with
EasyControl-A app,
SoundClip-A, or RC-A
Green, short blink
Red/orange, short blink
Sound
2 beeps
3 beeps
1 click
–
LED
Green, long blink
Red/orange, long blink
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 old).
Tinnitus SoundSupport is targeted to licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing loss. Fitting of Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program.
47
48
Guidelines for tinnitus sound generator users
These instructions contain information about Tinnitus
SoundSupport, which may have been enabled in your hearing aids by your hearing care professional.
Tinnitus SoundSupport is a tinnitus management device intended to generate sound of sufficient intensity and bandwidth to help manage tinnitus.
Your hearing care professional will also be able to offer the appropriate follow-up care. It is important to follow his/her advice and directions regarding such care.
Prescription use only
Good health practice requires that a person reporting tinnitus has had a medical evaluation by a licensed ear physician before using a sound generator. The purpose of such an evaluation is to ensure that any medically treatable condition that may cause tinnitus is identified and treated prior to using a sound generator.
Sound options and volume adjustment
Tinnitus SoundSupport is programmed by your hearing care professional to match your hearing loss and preferences for tinnitus relief. It offers a number of different sound options. Together with your hearing care professional, you can select your preferred sound(s).
Tinnitus SoundSupport programs
Together with your hearing care professional, you decide in which programs you may want to have
Tinnitus SoundSupport activated. The sound generator can be activated in up to four different programs.
Volume adjustments with Tinnitus
SoundSupport
When you select a hearing aid program in which
Tinnitus SoundSupport is activated, your hearing care professional can only set the push button on your hearing aid to work as a volume control for the tinnitus relief sound.
Your hearing care professional will set the volume control for the sound generator in one of two ways:
A) change volume in each ear separately, or
B) change volume in both ears simultaneously.
49
50
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 upper part of the push button repeatedly until desired level is reached. To decrease volume (on only one hearing aid), use a short press on the lower part of the push button repeatedly until desired level is reached.
B) How to change Tinnitus SoundSupport volume in both ears simultaneously
You can use one hearing aid to increase/decrease the sound in both hearing aids. When changing the volume in one hearing aid, the volume on the other hearing aid will follow. To increase volume, use a short press on the upper part of the push button repeatedly. To decrease volume, use a short press on the lower part of the push button repeatedly.
To be filled out by your hearing care professional.
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.
Your hearing care professional will advise you of the maximum amount of time per day you should use
Tinnitus SoundSupport. It should never be used at uncomfortable levels.
See table “Tinnitus SoundSupport: Limitation on use” at the end of this booklet to learn how many hours per day you can safely use the relief sound in your hearing aids.
51
52
Important information for hearing care professionals about
Tinnitus SoundSupport
Device description
Tinnitus SoundSupport is a module function that can be enabled in the hearing aids by the hearing care professional.
Maximum wearing time
The wearing time of Tinnitus SoundSupport will decrease as you increase the level above
80 dB(A) SPL. The fitting software will automatically display a warning when the hearing aid exceeds
80 dB(A) SPL. See “Max Wearing Time” indicator above the tinnitus fitting graph in the fitting software.
The volume control is deactivated
By default, the volume control for the sound generator is deactivated in the hearing aid. Risk of noise exposure increases when the volume control is activated.
If the volume control is activated
A warning may be displayed if you activate the tinnitus volume control in the “Local Controls” screen. This occurs if the relief sound can be listened to at levels that may cause hearing damage. The
“Limitation on Use” table in the fitting software displays the number of hours the patient can safely use Tinnitus SoundSupport.
·
Note the max wearing time for each program in which Tinnitus SoundSupport is activated.
·
Write those values in the table: “Tinnitus
SoundSupport: Limitation on use”, in the back of this booklet.
·
Instruct your patient accordingly.
The Tinnitus SoundSupport is manufactured for
Bernafon AG.
53
54
Warnings related to
Tinnitus SoundSupport
If your hearing care professional has activated the sound generator Tinnitus SoundSupport, please pay attention to the following warnings.
There are some potential concerns associated with the use of any sound generated by a tinnitus management device. Among them are the potential worsening of tinnitus, and/or a possible change in hearing thresholds.
Should you experience or notice a change in hearing or tinnitus, or any dizziness, nausea, headaches, heart palpitations, or possible skin irritation at the point of contact with the device, you should immediately discontinue use of the device and consult a medical, audiology, or other hearing care professional.
As with any device, misuse of the sound generator feature may cause potentially harmful effects. Care should be taken to prevent unauthorized use and to keep the device out of reach of children and pets.
Maximum wearing time
Always follow the maximum wearing time per day of the Tinnitus SoundSupport advised by your hearing care professional. Prolonged use may lead to worsening of your tinnitus or of your hearing loss.
General warnings
You should familiarize yourself fully with the following general warnings before using your hearing aid for your personal safety and to ensure correct use.
Please note that a hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions.
Furthermore, note that in most cases, infrequent use of a hearing aid does not permit a user to attain full benefit from it.
Consult your hearing care professional if you experience unexpected operations or events with your hearing aid.
This hearing aid is supported by a non-removable rechargeable lithium-ion battery cell. Please ensure that you charge the hearing aid and familiarize yourself with the safety and handling information related to rechargeable hearing aids.
Do not try to get access to the battery inserted in the hearing instrument. The battery must only be replaced by your hearing care professional.
Only charge the hearing aid with a Bernafon charger.
Other chargers risk destroying the hearing aid and battery.
If a battery or hearing aid is swallowed, see a doctor immediately.
55
56
General warnings
Usage of hearing aids
·
Hearing aids should be used only as directed and adjusted by your hearing care professional. Misuse can result in sudden and permanent hearing loss.
·
Never allow others to wear your hearing aid, as incorrect usage could cause permanent damage to their hearing.
Choking hazards & risk of swallowing small parts
·
Hearing aids and their parts should be kept out of reach of children and anyone who might swallow these items or otherwise cause injury to themselves.
·
Fatality hazards and risk of swallowing lithium-ion batteries or placing them in the ear or nose
Never swallow lithium-ion batteries nor place them in the ear or the nose as this may lead to serious injury or death in as little as 2 hours. This can be due to chemical burn, which can cause permanent damage to the nose or ear or potentially lead to perforation of the inner organs. If a lithium-ion battery is swallowed or placed in the ear or nose, see a doctor immediately. Keep the batteries in the original package until use. Dispose of used batteries immediately.
Rechargeable battery
·
Do not attempt to open the hearing aid, as it may damage the battery.
·
Never attempt to replace the battery. If battery replacement is needed, please return your device to the supplier. The service guarantee is void if there are signs of tampering.
·
The safety of recharging batteries using a USB connector is determined by the external signal source. When connected to external equipment plugged into a wall outlet, this equipment must comply with IEC-62368 (or IEC-60065, IEC- 60950 until June 20, 2019) or equivalent safety standards.
Dysfunction
·
Be aware of the possibility that your hearing aid may stop working without notice. Keep this in mind when you depend on warning sounds (e.g. when you are in traffic). The hearing aids may stop functioning, for instance if the batteries have expired or if the tubing is blocked by moisture or ear wax.
57
58
General warnings
Active implants
·
The hearing aid has been thoroughly tested and characterized for human health according to international standards for human exposure
(Specific Absorption Ratio – SAR), induced electromagnetic power and voltages into the human body.
·
The exposure values are well below internationally accepted safety limits for SAR, induced electromagnetic power and voltages into the human body defined in the standards for human health and coexistence with active medical implants such as pacemakers and heart defibrillators.
·
If you have an active brain implant, please contact the manufacturer of your implantable device for information about the risk of disturbance.
·
The MultiTool (which has a built-in magnet) should be kept more than 30 cm away from the implant, e.g. do not carry it in a breast pocket.
X-ray, CT, MR, PET scanning and electrotherapy
·
Remove your hearing aid before X-ray, CT/MR/PET scanning electrotherapy, surgery etc. as your hearing aid may be damaged when exposed to strong electromagnetic fields.
Heat and chemicals
·
The hearing aid must never be exposed to extreme heat e.g. left inside a parked car in the sun.
·
The hearing aid must not be dried in microwave ovens or other ovens.
·
The chemicals in cosmetics, hairspray, perfume, aftershave lotion, suntan lotion and insect repellent can damage the hearing aid. Always remove your hearing aid before applying such products and allow time to dry before use.
Power instrument
·
Special care should be exercised in selecting, fitting and using a hearing aid where maximum sound pressure capability exceeds 132 dB SPL (IEC 711), as there may be risk of impairing the remaining hearing of the hearing aid user.
For information on whether your hearing aid is a power instrument, see the "Model overview" section in the front of this booklet.
Possible side effects
·
Hearing aids and earpieces may cause an accelerated accumulation of ear wax.
·
The non-allergenic materials used in hearing aids may in rare cases cause a skin irritation or other side effects.
Please seek consultation with a physician if these conditions occur.
59
60
General warnings
Interference
·
The hearing aid has been thoroughly tested for interference, according to the most stringent international standards. However, interference between the hearing aid and other devices (e.g. some mobile telephones, citizens band systems and shop alarm systems and other devices) may occur. If this occurs, increase the distance between the hearing aid and the interfering device.
Use on aircraft
·
Your hearing aid contains Bluetooth
®
. On board an aircraft, flight mode must be activated or the hearing aid needs to be turned off, unless
Bluetooth
®
is permitted by the flight personnel.
Connection to external equipment
·
The safety of the hearing aid when connected to external equipment with an auxiliary input cable and/or with a USB cable and/or directly, is determined by the external signal source. When connected to external equipment plugged into a wall outlet, this equipment must comply with
IEC-62368 (or IEC-60065, IEC-60950 until
June 20, 2019) or equivalent safety standards.
Consult your hearing care professional if you experience unexpected operations or serious incidents with your hearing aid during use or because of its use. Your hearing care professional will support you with issue handling and, if relevant, reporting to the manufacturer and/or the national authorities.
Your hearing aid is only a part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading.
Explosives
The hearing aid is safe to use under normal usage conditions. The hearing aid has not been tested for compliance with international standards concerning explosive environments. Therefore, do not use the hearing aid in environments with danger of explosions e.g. mines, oxygen rich environments or areas where flammable anesthetics are handled.
Modification of hearing aids is not allowed
Changes or modifications not expressly approved by the manufacturer will void the warranty of the equipment.
61
62
Incompatible non-supplied accessories
Only use accessories, transducers or cables supplied by the manufacturer. Incompatible accessories may result in reduced electromagnetic compatibility
(EMC) of your device.
Only use your hearing aid in areas where wireless transmission is permitted.
Interference
Electromagnetic interference may occur in the vicinity of equipment with the symbol to the right. Portable and mobile RF (radio frequency) communications equipment can affect the performance of your hearing aid. If your hearing aid is affected by electromagnetic interference, move away from the source to reduce the interference.
Notes
63
64
Troubleshooting guide
Symptom
No sound
Possible causes
Hearing aid is out of power
Dead battery
Clogged earpieces
(dome, Grip Tip, Micro Mold, or Lite Tip)
Intermittent or reduced sound
Clogged sound outlet
Moisture
Hearing aid is out of power
Hearing aid earpiece inserted incorrectly
Squealing noise
Beeping
Ear wax accumulated in ear canal
If your hearing aid plays
8 beeps, 4 times consecutively, your hearing aid needs a microphone service check
The charger is not switched on
The hearing aid or charger is either too warm or too cold
Hearing aid LED remains off when the hearing aid is placed in the charger
Charging is incomplete. The room temperature exceeds +35 ºC, which prolongs the charging time.
The charger has stopped charging to protect the battery.
The hearing aid is not correctly inserted into the charger
Solutions
Charge the hearing aid
Contact your hearing care professional
Clean mold
Replace wax filter, dome, or Grip Tip
Clean mold or replace wax filter, dome, or Grip Tip
Gently wipe the hearing aid and let it dry
Charge the hearing aid
Re-insert the earpiece
Have ear canal examined by your doctor
Contact your hearing care professional
Verify that the charger power supply is connected correctly
Move the charger and hearing aid to a location with a temperature between +5 °C to +40 °C
Reinsert the hearing aid into the charger. This will complete the charging within approximately 15 minutes.
Check the charger slots for foreign objects
Symptom
No sound
Possible causes
Hearing aid is out of power
Dead battery
Clogged earpieces
(dome, Grip Tip, Micro Mold, or Lite Tip)
Intermittent or reduced sound
Clogged sound outlet
Moisture
Hearing aid is out of power
Hearing aid earpiece inserted incorrectly
Squealing noise
Beeping
Ear wax accumulated in ear canal
If your hearing aid plays
8 beeps, 4 times consecutively, your hearing aid needs a microphone service check
The charger is not switched on
The hearing aid or charger is either too warm or too cold
Hearing aid LED remains off when the hearing aid is placed in the charger
Charging is incomplete. The room temperature exceeds +35 ºC, which prolongs the charging time.
The charger has stopped charging to protect the battery.
The hearing aid is not correctly inserted into the charger
Solutions
Charge the hearing aid
Contact your hearing care professional
Clean mold
Replace wax filter, dome, or Grip Tip
Clean mold or replace wax filter, dome, or Grip Tip
Gently wipe the hearing aid and let it dry
Charge the hearing aid
Re-insert the earpiece
Have ear canal examined by your doctor
Contact your hearing care professional
Verify that the charger power supply is connected correctly
Move the charger and hearing aid to a location with a temperature between +5 °C to +40 °C
Reinsert the hearing aid into the charger. This will complete the charging within approximately 15 minutes.
Check the charger slots for foreign objects
65
66
Symptom
The hearing aid LED blinks red/orange when the hearing aid is placed in the charger
Possible causes
System error
Bluetooth ® connection failed
Pairing issue with Apple device
Only one hearing aid paired
Solutions
Contact your hearing care professional
1. Unpair your hearing aids
(Settings g Accessibility g MFi Hearing Devices g Devices g Forget this device).
2. Turn Bluetooth
®
off and on again.
3. Turn off and turn back on the hearing aid.
4. Re-pair hearing aids
(see section “Pairing hearing aid with iPhone”).
Symptom
The hearing aid LED blinks red/orange when the hearing aid is placed in the charger
Possible causes
System error
Bluetooth ® connection failed
Pairing issue with Apple device
Only one hearing aid paired
Solutions
Contact your hearing care professional
1. Unpair your hearing aids
(Settings g Accessibility g MFi Hearing Devices g Devices g Forget this device).
2. Turn Bluetooth
®
off and on again.
3. Turn off and turn back on the hearing aid.
4. Re-pair hearing aids
(see section “Pairing hearing aid with iPhone”).
If none of the above solutions work, consult your hearing care professional for assistance.
67
Water & dust resistance (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 sweat or getting wet in the rain.
Should your hearing aid come in contact with water and stop working, gently wipe off any water and let the hearing aid dry. Before charging the hearing aid make sure to wipe off any moisture.
68
Important notice
Do not wear your hearing aid while showering or participating in water activities. Do not immerse your hearing aid in water or other liquids.
Conditions of use
Operating conditions
Charging conditions
Storage and transportation conditions
Temperature: +5 °C to +40 °C
Relative humidity:
5 % to 93 %, non-condensing
Temperature: +5 °C to +40 °C
Relative humidity:
5 % to 93 %, non-condensing
Temperature and humidity should not exceed the following limits for extended periods during:
Transport
Temperature: –20 °C to +60 °C
Relative humidity:
5 % to 93 %, non-condensing
Storage
Temperature: –20 °C to +30 °C
Relative humidity:
5 % to 93 %, non-condensing
For information about the charger’s conditions of use, see the charger’s Instructions for Use.
69
Warranty certificate
Name of owner:
Hearing care professional:
Hearing care professional address:
Hearing care professional phone:
Purchase date:
Warranty period:
Model right:
Model left:
Month:
Serial no.:
Serial no.:
70
International warranty
Your hearing aid is covered by an international limited warranty issued by the manufacturer for a period of
12 months from the date of delivery. This limited warranty covers manufacturing and material defects in the hearing aid itself, but not in accessories such as batteries, tubing, speakers, earpieces and filters, etc. Problems arising from improper/incorrect handling or care, excessive use, accidents, repairs made by an unauthorized party, exposure to corrosive conditions, physical changes in your ear, damage due to foreign objects entering the device or incorrect adjustments are NOT covered by the limited warranty and may void it. The above warranty does not affect any legal rights that you might have under applicable national legislation governing sale of consumer goods. Your hearing care professional may have issued a warranty that goes beyond the clauses of this limited warranty. Please consult him/ her for further information.
If you need service
Take your hearing aid to your hearing care professional, who may be able to sort out minor problems and adjustments immediately.
71
72
Technical information
The hearing aid contains two radio technologies, which are described below:
The hearing aid contains a radio transceiver using short range magnetic induction technology working at 3.84 MHz. The magnetic field strength of the transmitter is very weak and is always below 15 nW
(typically below –40 dBμA/m at 10 meter distance).
The hearing aid also contains a radio transceiver using Bluetooth
®
Low Energy (BLE) and a proprietary short range radio technology both working at
2.4 GHz. The 2.4 GHz radio transmitter is weak and is always below 3 mW equal to 4.8 dBm e.i.r.p. in total radiated power.
The hearing aid complies with international standards concerning electromagnetic compatibility and human exposure.
Due to the limited space available on the hearing aid, relevant approval markings can be found in this document.
Additional information can be found in the Product
Information sheet on www.bernafon.com.
USA and Canada
The hearing aid contains a radio module with the following certification ID numbers:
FCC ID: U6XAUMRTRC
IC: 7031A-AUMRTRC
The manufacturer declares that this hearing aid is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU.
Declaration of Conformity is available from the manufacturer.
Bernafon AG
Morgenstrasse 131
3018 Bern
Switzerland
Waste from electronic equipment must be handled according to local regulations.
E2105
73
74
Your individual hearing aid settings
To be filled out by your hearing care professional
Left
Settings overview for your hearing aid
Right
Volume control
Program shift
Tinnitus SoundSupport
Volume control indicators
Beeps at min/max volume
Clicks when changing volume
Beeps at preferred volume
Battery indicators
Low battery tones
Tinnitus SoundSupport: Limitation on use
No limitation on use
Program
1
2
3
4
Start-up volume
(Tinnitus)
Max
Max
Max
Max hours per day hours per day hours per day hours per day
Max volume
(Tinnitus)
Max
Max
Max
Max hours per day hours per day hours per day hours per day
75
76
Description of symbols used in this booklet or on the packaging label
E2105
IP68
Warnings
Text marked with a marking symbol must be read before using the product.
Manufacturer
The product is produced by the manufacturer whose name and address are stated next to the symbol.
Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and
98/79/EC.
CE mark
The product complies with Medical Device Directive
93/42/EEC. The four digits number indicates the identification of the notified body.
Electronic waste (WEEE)
Recycle your hearing aids, accessories or batteries according to local regulations or return them to your hearing care professional for disposal.Electronic equipment covered by Directive 2012/19/EU on waste and electrical equipment (WEEE).
Regulatory Compliance Mark (RCM)
The product complies with electrical safety, EMC and radio spectrum requirements for products supplied to the Australian or New Zealand market.
IP code
This symbol indicates the class of protections against harmful ingress of water and particulate matter according to EN 60529:1991/A1:2002.IP6X indicates total dust protection. IPX8 indicates the protection against the effects of continuous immersion in water.
Bluetooth
®
logo
Registered trademark of Bluetooth
®
SIG, Inc. where any use of such requires a license.
Made for iPod, iPhone, and iPad
Indicates that the device is compatible with iPod, iPhone, and iPad.
Keep dry
Indicates a medical device that needs to be protected from moisture.
REF
SN
Caution symbol
Consult instructions for use for warnings and cautions.
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.
Use by date
Indicates the date after which the medical device is not to be used.
Battery recycling symbol
Li-Ion battery recycling symbol.
Temperature limit
Indicates the temperature limits to which the medical device can be safely exposed.
Humidity limitation
Indicates the range of humidity to which the medical device can be safely exposed.
Hearing loop
This logo incorporates the universal symbol for hearing assistance. The "T" signifies that a hearing loop is installed.
Medical Device
The device is a medical device.
Radio Frequency (RF) transmitter
Your hearing aid contains an RF transmitter.
GTIN
Global Trade Item Number
A globally unique 14-digit number used to identify medical device products including medical device software. GTIN in this booklet is related to medical device firmware (inside the hearing aid). GTIN on regulatory packaging label is related to medical device hardware (the hearing aid itself).
77
78
214769/UK
Placeholder for FSC logo
< 15 mm >
< >
8,15 mm
UK ab Zerena OHNE Canada - 28.07.2017 aoho
Manufacturer:
Bernafon AG
Morgenstrasse 131
3018 Bern
Switzerland www.bernafon.com
0000214769000001
Λήψη
Δημόσιος σύνδεσμος ενημερώθηκε
Ο δημόσιος σύνδεσμος για τη συνομιλία σας ενημερώθηκε. You may view and manage your chat links after registration here.
Δημόσιος σύνδεσμος εγγράφου
Διαφήμιση
