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Phonak Virto
TM
M
User Guide
Phonak Virto M-312/312 NW O/Titanium/10 NW O
This user guide is valid for:
Wireless models
Phonak Virto M90-312
Phonak Virto M70-312
Phonak Virto M50-312
Phonak Virto M30-312
CE mark applied
2019
2019
2019
2019
Non wireless models
Phonak Virto M90-312 NW O
Phonak Virto M70-312 NW O
Phonak Virto M50-312 NW O
Phonak Virto M30-312 NW O
Phonak Virto M90-Titanium
Phonak Virto M70-Titanium
Phonak Virto M90-10 NW O
Phonak Virto M70-10 NW O
Phonak Virto M50-10 NW O
Phonak Virto M30-10 NW O
CE mark applied
2019
2019
2019
2019
2019
2019
2019
2019
2019
2019
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Your hearing aids have been developed by
Phonak – the world leader in hearing solutions based in Zurich, Switzerland.
These premium products are the result of decades of research and expertise and are designed to keep you connected to the beauty of sound! We thank you for making such a great choice and wish you many years of listening pleasure.
Please read the user guide carefully to make sure that you understand and get the best out of your hearing aids.
For more information about features and benefits, simply contact your hearing care professional.
Phonak – life is on www.phonak.com
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Your hearing aid details
If no box is checked and you do not know the model of your hearing aid, please ask your hearing care professional.
Your Virto M-312 hearing aids operate between
2.4 GHz–2.48 GHz frequency range. When flying please check if flight operator requires devices to be switched into flight mode, see chapter 14.
Model c
Phonak Virto M-312 c
Phonak Virto M-312 NW O c
Phonak Virto M-Titanium c
Phonak Virto M-10 NW O
Battery size
312
312
10
10
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Contents
Your hearing aid
1. Quick guide
2. Parts of the hearing aid
8
10
Using the hearing aid
3. Left and right hearing aid markings
4. On/Off
5. Batteries
6. Putting on the hearing aid
7. Removing the hearing aid
8. Push button
9. Volume control
10. Adjusting Virto M-Titanium or Virto M-10 NW O
with Phonak MiniControl
11. Connectivity overview Virto M-312
12. Initial pairing Virto M-312
13. Phone calls Virto M-312
14. Flight mode Virto M-312
15. Join our hearing loss community!
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19
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21
12
13
14
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Further Information
16. Care and maintenance
17. Service and warranty
18. Compliance information
19. Information and description of symbols
20. Troubleshooting
21. Important safety information
22. For the US market only, complies with the FDA regulations
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1. Quick guide
Left and right hearing aid markings
Blue marking for left hearing aid.
Red marking for right hearing aid.
Left Right
Changing batteries
1.
Remove the sticker from the new battery and wait two minutes.
2.
Open the battery door.
3.
Place battery in the battery door with the
“+” symbol facing upwards.
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On/Off
On Off
Push button
Models with this option only:
The push button on your hearing aid can have various functions.
Volume control
Models with this option only:
To increase the volume, turn the volume control forwards. To decrease the volume, turn the volume control backwards.
Flight mode Virto M-312
To enter flight mode press the push button for 7 seconds while closing the battery door. To exit flight mode, simply open and close the battery door again.
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2. Parts of the hearing aid
The following pictures show the models described in this user guide. You can identify your personal model by:
• Checking “Your hearing aid details” on page 5.
• Or comparing your hearing aid with the following shown models. Pay attention to the shape of the hearing aid and if a volume control is present.
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Virto M-312
Sound outlet / wax protection system
Push button
Volume control
(optional)
Custom made shell
Battery door
Virto M-312 NW O
Sound outlet / wax protection system
Custom made shell
Battery door
Virto M-Titanium and Virto M-10 NW O
Sound outlet / wax protection system
Push button
(optional)
Removal handle
Custom made shell
Battery door
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3. Left and right hearing
aid markings
There is a red or blue marking to tell you if it is a left or a right hearing aid. The color mark is located on the battery door, on the shell (text printed in red or blue) or shell is colored red or blue.
Blue marking for left hearing aid.
Red marking for right hearing aid.
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4. On/Off
The battery door is also the on/off switch.
1.
Closed battery door = hearing aid is on
2.
Opened battery door = hearing aid is off
When you switch on the hearing aid you may hear a start-up melody.
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5. Batteries
1.
Remove the sticker from the new battery and wait two minutes.
2.
Open the battery door.
3.
Place battery in the battery door with the
“+” symbol facing upwards.
If it is difficult to close the battery door: Check that the battery is inserted correctly and the “+” symbol is facing upwards. If the battery is not inserted correctly, the hearing aid will not work and the battery door can be damaged.
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Low power: You will hear two beeps when the battery is low. You will have approximately 30 minutes to change the battery (this can vary, depending on the hearing aid settings and battery). We recommend that you always have a new battery on hand.
Replacement battery
This hearing aid requires zinc-air batteries. Identify the correct battery size (312 or 10) by:
• Checking “Your hearing aid details” on page 5.
• Checking the marking on the inner side of the battery door.
• Checking the following table.
Model ANSI code
Phonak Virto
M-312
M-312 NW O
M-Titanium
M-10 NW O
Zinc air battery size
312
312
10
10
Color marking on package brown brown yellow yellow
IEC code
PR41
PR41
PR70
PR70
7002ZD
7002ZD
7005ZD
7005ZD
Please ensure you use the correct type of battery in your hearing aids (zinc-air). Please also read chapter
21.2 for further information on product safety.
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6. Putting on the hearing aid
(all models)
1.
Take your hearing aid up to your ear and place the ear canal part into your ear canal.
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7. Removing the hearing aid
7.1 Removing the hearing aid with a removal handle
1.
Hold the removal handle and carefully pull the hearing aid up and out of the ear.
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7.2 Removing the hearing aid without a removal handle
1.
Put your thumb behind your lobe and gently press your ear upward to push the hearing aid out of the canal. In order to help it along, make chewing movements with your jaw.
2.
Grasp the protruding hearing aid and remove it.
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8. Push button
Models with this option only:
The push button on your hearing aid can have various functions or is not active. This depends on the programming of the hearing aid, which is indicated in your individual “Hearing aid instructions”. Please ask your hearing care professional for this printout.
Virto M-312:
If your hearing aid is paired with a Bluetooth® enabled phone, a short press on the push button will accept an incoming call and a long press will reject an incoming call – refer to chapter 13.
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9. Volume control
Models with this option only:
To increase the volume, turn the volume control forwards (towards nose).
To decrease the volume, turn the volume control backwards (towards back of head). The volume control can be disabled by the hearing care professional.
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10. Adjusting Virto M-Titanium
or Virto M-10 NW O with
Phonak MiniControl
The MiniControl contains a magnet that functions like a remote control to change the settings of your
Virto M-Titanium or Virto M-10 NW O.
Your Virto M-Titanium or Virto M-10 NW O in combination with MiniControl can have various functions or can remain inactive. This depends on your individual settings, which are indicated in your individual “Hearing aid instructions”. Please ask your hearing care professional for this print out.
To use the MiniControl, unscrew the magnet from the keychain housing and hold it inside the ear canal without touching the hearing aid.
Keychain housing
MiniControl magnet
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While the hearing aid is on, hold the magnet inside the ear canal without touching the hearing aid. Promtly remove the magnet as soon as your
Virto M-Titanium or
Virto M-10 NW O is in the desired program or the volume is ideal for you.
If you use a medical device like a pacemaker or ICD device (implantable cardioverter defibrillator), please read the specific user guide to clarify possible impact of magnetic fields to your medical device.
Do not place the MiniControl (neither open nor closed) in your breast pocket. Keep a distance of at least 15 cm (6 inches) between the MiniControl and any medical device.
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11. Connectivity overview
Virto M-312
The illustration below shows the connectivity options available for your hearing aid.
Cell phone
Roger**
TV Connector connected to TV*
* The TV Connector can be connected to any audio source such as a TV, PC or hi-fi system.
** Roger wireless microphones can be connected to your hearing aids as well.
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12. Initial pairing Virto M-312
12.1 Initial pairing to Bluetooth® enabled device
It is only necessary to perform the pairing procedure once with each device featuring Bluetooth wireless technology. After the initial pairing, your hearing aids will connect automatically to the device. This can take up to 2 minutes.
1.
On your device (e.g. a phone), ensure that Bluetooth wireless technology is enabled and search for Bluetooth enabled devices in the connectivity setting menu.
2.
Switch on both hearing aids.
You now have 3 minutes to pair your hearing aids with your device.
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3.
Select the hearing aid in the list of Bluetooth enabled devices. This will pair both hearing aids simultaneously.
A beep confirms successful pairing.
For more information about pairing instructions for
Bluetooth wireless technology, specific to some of the most popular phone manufacturers, go to: https://marvel-support.phonak.com
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12.2 Connecting to the device
After your hearing aids have been paired to your device, they will automatically connect again when switched on.
The connection will be maintained as long as the device remains ON and within range.
Your hearing aids can be paired to up to two devices.
Your hearing aids can be connected to one device at a time.
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13. Phone calls Virto M-312
Your hearing aids connect directly with Bluetooth® enabled phones. When paired and connected to your phone, you will hear the caller’s voice directly in your hearing aids. Your hearing aids pick up your voice through their own microphones.
Your voice
Caller’s voice
Bluetooth® is a registered trademark owned by the Bluetooth SIG, Inc.
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13.1 Making a call
Enter the phone number and press the dial button.
You will hear the ring tone through your hearing aids.
Your hearing aids pick up your voice through their own microphones.
13.2 Accepting a call
When receiving a call, a calling notification will be heard in the hearing aids.
The call can be accepted by a short press on the push button on the hearing aid (less than 2 seconds) or directly on your phone.
short press
< 2 sec
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13.3 Ending a call
A call can be ended by a long press on the push button on the hearing aid (more than 2 seconds) or directly on your phone.
long press
> 2 sec
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13.4 Rejecting a call
An incoming call can be rejected by a long press on the push button on the hearing aid (more than 2 seconds) or directly on your phone.
long press
> 2 sec
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14. Flight mode Virto M-312
Your hearing aids operate between 2.4 GHz–2.48 GHz frequency range. When flying some operators require all devices to be switched into flight mode. Entering flight mode will not disable normal hearing aid functionality, only the Bluetooth connectivity functions.
14.1 Enter flight mode
To disable the wireless function and enter flight mode in each hearing aid:
1.
Open battery door.
2.
Hold down the push button on the hearing aid for 7 seconds while closing the battery door.
In flight mode, your hearing aid cannot connect directly to your phone.
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14.2 Exit flight mode
To enable the wireless function and exit flight mode in each hearing aid:
1.
Open battery door.
2.
Close the battery door again.
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15. Join our hearing loss community!
On HearingLikeMe.com you will find:
• Living with Hearing Loss
A set of interesting articles on how to live with hearing loss.
• Forum
A forum to meet and engage with a growing number of people who face the same challenges.
• Blog
A blog to keep up-to-date with the latest news on anything hearing.
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16. Care and maintenance
Diligent and routine care of your hearing aid contributes to outstanding performance and a long service life. To ensure a long service life, Sonova AG provides a minimum of a five year service period after phase out of the respective hearing aid.
Please use the following specifications as a guideline.
For further information regarding product safety, see chapter 21.2.
General information
Before using hair spray or applying cosmetics, you should remove your hearing aid from your ear, because these products may damage it.
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Daily
Daily cleaning and the use of a drying system is highly recommended. C&C line from Phonak is a complete set of cleaning products. Your hearing care professional will be glad to advise you. Never use household cleaning products
(washing powder, soap, etc.) to clean your hearing aids.
If your hearing aid is performing weakly or fails to operate, clean or replace the wax guard system. If your hearing aid fails to operate after you have correctly cleaned or replaced your wax protection system and inserted new batteries, contact your hearing care professional for advice.
Weekly
For more in depth maintenance instructions or for more than basic cleaning, please see your hearing care professional.
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17. Service and warranty
Local warranty
Please ask the hearing care professional where you purchased your hearing aid about the terms of the local warranty.
International warranty
Sonova AG offers a one year limited international warranty, valid starting from the date of purchase.
This limited warranty covers manufacturing and material defects in the hearing aid itself, but not accessories such as batteries, tubes, earmolds and external receivers.
The warranty only comes into force if a proof of purchase is shown.
The international warranty does not affect any legal rights that you might have under applicable national legislation governing sale of consumer goods.
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Warranty limitation
This warranty does not cover damage from improper handling or care, exposure to chemicals or undue stress.
Damage caused by third parties or non-authorized service centers renders the warranty null and void. This warranty does not include any services performed by a hearing care professional in their office.
Serial number
(left side):
Authorized hearing care professional (stamp/signature):
Serial number
(right side):
Date of purchase:
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18. Compliance information
Europe:
Declaration of Conformity
Hereby Sonova AG declares that this product meets the requirements of the Medical Devices Directive 93/42/EEC as well as the Radio Equipment Directive 2014/53/EU. The full text of the EU Declaration of Conformity can be obtained from the manufacturer or the local Phonak representative whose address can be taken from the list on www.phonak.com/us/en/certificates (Phonak worldwide locations).
Australia/New Zealand:
Indicates a device’s compliance with applicable
Radio Spectrum Management’s (RSM) and
Australian Communications and Media Authority
(ACMA) regulatory arrangements for the legal sale in New Zealand and Australia.
The compliance label R-NZ is for radio products supplied in the New Zealand market under conformity level A1.
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The wireless models listed on page 2 are certified under:
Phonak Virto M-312, models M / P / SP / UP
USA
Canada
FCC ID: KWC-IND Phonak Virto Mxx*-312 left
KWC-INR Phonak Virto Mxx*-312 right
IC: 2262A-IND
2262A-INR
* xx denotes performance level 90, 70, 50, 30
The equipment is designed not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission and ISED.
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Notice 1:
This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the following two conditions:
1) this device may not cause harmful interference, and
2) this device must accept any interference received, including interference that may cause undesired operation.
Notice 2:
Changes or modifications made to this device not expressly approved by Sonova AG may void the FCC authorization to operate this device.
Notice 3:
This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules and ICES-003 of Industry Canada.
These limits are designed to provide reasonable protection against harmful interference in a residential installation.
This device generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful
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interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this device does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the device and receiver.
• Connect the device into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
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Radio information of your hearing aid
Antenna type
Operation frequency
Modulation
Radiated power
Bluetooth®
Range
Bluetooth
Profiles supported
Resonant loop antenna
2.4 GHz – 2.48 GHz
GFSK, Pi/4 DPSK, GMSK
< 1 mW
~1m
4.2 Dual-Mode
HFP (Hands-free profile), A2DP
Compliance with emission and immunity standards
Emission standards EN 60601–1-2:2015
IEC 60601–1-2:2014
EN 55011:2009+A1
CISPR11:2009/AMD1:2010
CISPR22:1997
CISPR32:2012
ISO 7637-2:2011
CISPR25:2016
EN 55025:2017
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Immunity standards EN 60601-1-2:2015
IEC 60601-1-2:2014
EN 61000-4-2:2009
IEC 61000-4-2:2008
EN 61000-4-3:2006+A1+A2
IEC 61000-4-3:2006+A1+A2
EN 61000-4-4:2012
IEC 61000-4-4:2012
EN 61000-4-5:2014
IEC 61000-4-5:2014
EN 61000-4-6:2014
IEC 61000-4-6:2013
EN 61000-4-8:2010
IEC 61000-4-8:2009
EN 61000-4-11:2004
IEC 61000-4-11:2004
IEC 60601-1 (§ 4.10.2):2005
ISO 7637-2:2011
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19. Information and description
of symbols
With the CE symbol, Sonova AG confirms that this product – including accessories – meets the requirements of the Medical Devices Directive
93/42/EEC as well as the Radio Equipment
Directive 2014/53/EU. The numbers after the
CE symbol correspond to the code of certified institutions that were consulted under the above-mentioned directives.
This symbol indicates that the products described in these user instructions adhere to the requirements for an applied part of Type B of EN 60601-1. The surface of the hearing aid is specified as an applied part of Type B.
Indicates the medical device manufacturer, as defined in EU Directive 93/42/EEC.
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This symbol indicates that it is important for the user to read and take into account the relevant information in these user guides.
This symbol indicates that it is important for the user to pay attention to the relevant warning notices in these user guides.
Important information for handling and product safety.
During transportation keep dry.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG,
Inc. and any use of such marks by Sonova AG is under license. Other trademarks and trade names are those of their respective owners.
Japanese symbol for certified radio devices.
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Operating conditions
The product is designed such that it functions without problems or restrictions if used as intended, unless otherwise noted in this user guide. The hearing aid models Virto M-Titanium and Virto M-10 NW O are classified IP68 (depth of
1 meter for 60 minutes) and designed to be used in all daily life situations. However, the hearing aid is not intended to be used in water activities that includes chlorinated water, soap, salt water or other liquids with a chemical content.
Indicates the manufacturer’s serial number so that a specific medical device can be identified.
Indicates the manufacturer’s catalogue number so that the medical device can be identified.
Temperature during transportation and storage:
–20° to +60° Celsius (–4° to +140° Fahrenheit).
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Humidity during transportation: Up to 90%
(non condensing).
Humidity during storage: 0% to 70%, if not in use.
See instruction in chapter 21.2 regarding drying the hearing aid after use.
Atmospheric pressure: 500 hPa to 1060 hPa
The symbol with the crossed-out garbage bin is to make you aware that this hearing aid may not be thrown away as normal household waste. Please dispose of old or unused hearing aids, at waste disposal sites intended for electronic waste, or give your hearing aid to your hearing care professional for disposal. Proper disposal protects the environment and health.
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20. Troubleshooting
Problem
Hearing aid not functioning
Causes
Dead battery
Blocked sound outlet
Battery not inserted correctly
Hearing aid switched off
Hearing aid whistles
Hearing aid too loud
Hearing aid not loud enough or distorted
Hearing aid plays two beeps
Hearing aid switches on and off
(intermittent)
Hearing aid not inserted correctly
Earwax in ear canal
Volume too loud
Low battery
Blocked sound outlet
Volume too low
Physical hearing condition has changed
Indication for low battery
Moisture on battery or hearing aid
Phone call function does not work
(Virto M-312 only)
Hearing aid is in flight mode
Hearing aid not paired to the phone
If the problem persists, contact you hearing care professional for assistance.
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What to do
Change battery (chapter 5)
Clean sound outlet
Insert battery correctly (chapter 5)
Switch hearing aid on by completely closing the battery door
(chapter 4)
Insert hearing aid correctly (chapter 6)
Contact your ENT/GP or hearing care professional
Decrease volume if volume control available (chapter 8 + 9)
Change battery (chapter 5)
Clean sound outlet
Turn volume up if volume control available (chapter 8 + 9)
Contact you hearing care professional
Change battery within the next 30 minutes (chapter 5)
Wipe battery and hearing aid with dry cloth
Open and close battery door (chapter 14.2)
Pair it to the phone (chapter 12)
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21. Important safety information
Please read the information on the following pages before using your hearing aid.
A hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. Infrequent use of a hearing aid does not permit a user to attain full benefit from it. The use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading.
Hearing aids are suitable for the home healthcare environment and due to their portability it may happen that they are used in professional healthcare facility environments like physician offices, dental offices etc.
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21.1 Hazard warnings
Your Virto M-312 hearing aids operate between
2.4 GHz–2.48 GHz frequency range. When flying please check if flight operator requires devices to be switched into flight mode, see chapter 14.
The intended use of hearing aids is to amplify and transmit sound to the ears and hereby compensate for impaired hearing. The hearing aids (specially programmed for each hearing loss) must only be used by the intended person. They should not be used by any other person as they could damage hearing.
Changes or modifications to the hearing aid that were not explicitly approved by Sonova AG are not permitted.
Such changes may damage your ear or the hearing aid.
Do not use the hearing aids in explosive areas (mines or industrial areas with danger of explosions, oxygen-rich environments or areas where flammable anesthetics are handled).
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Hearing aid batteries are toxic if they are swallowed!
Keep out of the reach of children, individuals with cognitive impairment, and pets. If batteries are swallowed, consult your physician immediately!
If you feel pain in or behind your ear, if it is inflamed or if skin irritation and accelerated accumulations of earwax occur, please check with your hearing care professional or physician.
Titanium shells of custom hearing aids and earpieces can contain small quantities of acrylates from adhesives. People who are sensitive to such substances may potentially experience an allergic skin reaction. Please stop using the device immediately if such a reaction occurs and check with your hearing care professional or physician.
In very rare cases if not securely attached, a cerumen stop can remain in your ear canal when removing the hearing aid from the ear. In the unlikely case that such part gets stuck in your ear canal, it is strongly recommended to see a physician for safe removal.
Hearing programs in the directional microphone mode reduce background noises. Please be aware that warning signals or noises coming from behind, e. g. cars, are partially or entirely suppressed.
This hearing aid is not for children below 36 months. The usage of this device by children and individuals with cognitive impairment should be supervised at all times to ensure their safety. The hearing aid is a small device and contains small parts. Do not leave children and individuals with cognitive impairment unsupervised with this hearing aid. If swallowed, consult a physician or hospital immediately as the hearing aid or its parts can cause choking!
Do not make a wire connection from your hearing aid to any external audio sources like radio etc. That could cause injuries on your body (electric shock).
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The following is only applicable for persons with active implantable medical devices (i.e. pacemakers, defibrillators, etc.):
Keep the wireless hearing aid at least 15 cm (6 inches) away from the active implant. If you experience any interference, do not use the wireless hearing aids and contact the manufacturer of the active implant. Please, note that interference can also be caused by power lines, electrostatic discharge, airport metal detectors etc.
Keep magnets (i.e. battery handling tool, EasyPhone magnet, etc.) at least 15 cm (6 inches) away from the active implant.
If using a Phonak wireless accessory, consult the chapter
“Important safety information” in your wireless accessory user guide.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
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Virto M-312 only: Portable RF communications equipment
(including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the hearing aids, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Avoid strong physical impacts to the ear when wearing in-theear hearing aids. The stability of in-the-ear shells is designed for normal use. A strong physical impact to the ear (e.g. during sports) may cause the in-the-ear shell to break. This may lead to perforation of the ear canal or ear drum.
After mechanical stress or shock to the hearing aid, please ensure that the hearing aid shell is intact before placing it in the ear.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
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21.2 Information on product safety
Never immerse your hearing aid in water! Protect it from excessive moisture. Always remove your hearing aid before showering, bathing, or swimming, as the hearing aid contains sensitive electronic parts.
Protect your hearing aid from heat (never leave near a window or in the car). Never use a microwave or other heating devices to dry your hearing aid. Ask your hearing care professional about suitable drying methods.
When you are not using your hearing aid, leave the battery door open so that any moisture can evaporate. Make sure that you always completely dry your hearing aid after use. Store the hearing aid in a safe, dry and clean place.
Do not drop your hearing aid! Dropping onto a hard surface can damage your hearing aid.
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If you are not using your hearing aid for a long period of time, store it in a box with a drying capsule or in a well ventilated location. This allows moisture to evaporate from your hearing aid and prevents a potential impact on its performance.
Always use new batteries for your hearing aid. In case a battery is leaking, replace it immediately with a new one to avoid any skin irritation. You can return used batteries to your hearing care professional.
The batteries used in these hearing aids should not exceed
1.5 Volts. Please do not use silver-zinc or Li-ion (lithium-ion) rechargeable batteries as these may cause severe damage to your hearing aids. The table in chapter 5 explains exactly which type of battery your particular hearing aids require.
Remove the battery if you are not using your hearing aid for a long period of time.
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Special medical or dental examination including radiation described below, may adversely affect the correct functioning of your hearing aids. Remove and keep them outside the examination room/area before undergoing:
Medical or dental examination with X-ray (also CT scan).
Medical examinations with MRI/NMRI scans, generating magnetic fields.
Hearing aids don’t need to be removed when passing security gates (airports etc.). If X-ray is used at all, it will be in very low doses, and will not affect the hearing aids.
Do not use your hearing aid in areas where electronic equipment is prohibited.
Do not kink or buckle the removal handle. Repeated stress to the removal handle may cause it to break. In case of a broken removal handle the battery door may exceptionally be used to carefully pull the hearing aid out of the ear canal.
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22. For the US market only, complies with the FDA regulations
Important information: Cell phones
Some hearing aid users have reported a buzzing sound in their hearing aids when they are using cell phones.
According to the ANSI 63.19 (American National
Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing
Instruments) standard, the compatibility of a particular hearing aid and cell phone can be predicted by adding the rating for the hearing aid immunity to the rating for the cell phone emissions. The sum of the hearing aid rating (e.g. M2/T2=2) and the telephone rating
(e.g. M3/T3=3) is 5, and any combination that equals
5 will provide “normal use”; a sum of 6 or greater would indicate “excellent performance”. The equipment performance measurements, categories and system classifications are based upon the best information available but cannot guarantee that all users will be satisfied. The immunity of this hearing aid is at least M2/T2.
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Note: the performance of individual hearing aids may vary with individual cell phones. Therefore, please try the hearing aid with your cell phone or, if you are purchasing a new phone, be sure to try it with your hearing aid prior to purchase. For additional guidance, please ask your hearing care professional for the booklet entitled “hearing aid compatibility with digital wireless cell phones”.
Important information in case of battery ingestion
If a battery is swallowed, call the 24-hour National Battery
Ingestion Hotline at 202-625-3333 or consult your physician immediately.
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Warning to Hearing Aid Dispensers
A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed physician
(preferably an ear specialist) before dispensing a hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions:
(i) Visible congenital or traumatic deformity of the ear.
(ii) History of active drainage from the ear within the previous 90 days.
(iii) History of sudden or rapidly progressive hearing loss within the previous 90 days.
(iv) Acute or chronic dizziness.
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(v) Unilateral hearing loss of sudden or recent onset within the previous 90 days.
(vi) Audiometric air-bone gap equal to or greater than
15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.
(vii) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
(viii) Pain or discomfort in the ear. Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure level exceeds
132 decibels because there may be risk of impairing the remaining hearing of the hearing aid user. (This provision is required only for those hearing aids with a maximum sound pressure capability greater than
132 decibels (dB).)
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Important Notice for Prospective Hearing Aid Users
Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician
(preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists.
The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased.
Following the medical evaluation, the physician will give you a written statement that states that your hearing loss has been medically evaluated and that you may be considered a candidate for a hearing aid. The physician will refer you to an audiologist or a hearing aid dispenser, as appropriate, for a hearing aid evaluation.
The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will
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enable the audiologist or dispenser to select and fit a hearing aid to your individual needs.
If you have reservations about your ability to adapt to amplification, you should inquire about the availability of a trial-rental or purchase-option program. Many hearing aid dispensers now offer programs that permit you to wear a hearing aid for a period of time for a nominal fee after which you may decide if you want to purchase the hearing aid.
Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician. Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged.
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Children with Hearing Loss
In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss.
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Important notice for Prospective Noise Generator users
The Tinnitus Balance noise generator is a broadband sound
Generator which may have been enabled in your hearing aid. It provides a means of sound enrichment that can be used as part of a personalized tinnitus management program to provide temporary relief from tinnitus. It should always be used as prescribed by your audiologist.
The underlying principle of sound enrichment is to provide supplementary noise stimulation which can help defocus your attention from your tinnitus and avoid negative reactions. Sound enrichment, coupled with instructional counseling, is an established approach to managing tinnitus.
Good health practice requires that a person reporting tinnitus have a medical evaluation by a licensed ear physician before using a sound generator. The purpose of such an evaluation is to ensure medically treatable conditions that may be causing tinnitus are identified and treated prior to using a sound generator.
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Should you develop any side effects whilst using the noise generator such as headaches, nausea, dizziness or heart palpitations or experience a decrease in auditory function, you should discontinue use and seek a medical evaluation.
According to OSHA (Occupational Safety & Health
Administration, U.S. Department of Labor) regulations, the volume of the noise generator can be set to a level which could lead to permanent hearing damage when used for a prolonged period of time. Should the noise generator be set to such a level in your hearing aid, your audiologist will advise you of the maximum amount of time per day you should use the noise generator. The noise generator should never be used at uncomfortable levels.
For more information visit www.phonak.com
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Your hearing care professional:
Manufacturer:
Sonova AG
Laubisrütistrasse 28
CH-8712 Stäfa
Switzerland www.phonak.com
Public link updated
The public link to your chat has been updated.
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