Widex | EVOKE FUSION | User Instructions | Widex EVOKE FUSION User Instructions

Widex EVOKE FUSION User Instructions
USER INSTRUCTIONS
THE WIDEX EVOKE™ FAMILY
E-FS model
RIC/RITE
(Receiver-in-canal/Receiver-in-the-ear)
YOUR HEARING AID
(To be filled out by the hearing care professional)
Your hearing aid series:
 Zinc-air battery (steel colored)
PROGRAMS
 Silver-zinc battery (golden)
 Universal
 Audibility Extender
 Quiet
 Audibility Extender
 Comfort
 Audibility Extender
 Transport
 Audibility Extender
 Urban
 Audibility Extender
 Impact
 Audibility Extender
 Party
 Audibility Extender
 Social
 Audibility Extender
 Music
 Audibility Extender
T
 Audibility Extender
 M+T
 Audibility Extender
2
SPECIAL PROGRAMS
 Zen
 Audibility Extender
 Phone
 Audibility Extender
SMARTTOGGLE PROGRAMS
 Zen+
 Audibility Extender
 Phone+
 Audibility Extender
NOTE
The program names in the table are the default names. If you have chosen to
use some of the other names available, write the new names in the table. That
way you will always know which programs you have in your hearing aids.
NOTE
Read this booklet and the booklet "Ear-sets for Widex hearing aids" carefully
before you start using your hearing aid.
NOTE
If you are using silver-zinc batteries, read also the booklet "Instructions for use,
ZPower rechargeable system for hearing aids" carefully.
3
NOTE
This hearing aid allows direct wireless control and sound streaming from smartphones and other devices. For more help and information contact your hearing
care professional or visit: https://global.widex.com/EVOKE.
This hearing aid works wirelessly with the TONELINK App. We take no responsibility if the hearing aid is used with any third part App or if the TONELINK App is
used with any other device.
4
CONTENTS
YOUR HEARING AID................................................................................... 7
Welcome...........................................................................................................7
Your hearing aid at a glance....................................................................... 7
FS model with silver-zinc rechargeable batteries....................................8
The charger................................................................................................... 8
Important safety information.........................................................................9
THE HEARING AID..................................................................................... 11
Indications for use........................................................................................... 11
Hearing aids with rechargeable batteries.................................................11
Intended use.................................................................................................... 11
The zinc-air battery.........................................................................................11
Low battery indication............................................................................... 12
Changing the battery................................................................................. 12
Tamper-resistant battery drawer............................................................. 13
The silver zinc battery.................................................................................... 13
Inserting a rechargeable battery.............................................................. 14
Recharging your hearing aids................................................................... 15
Sound signals..................................................................................................16
Lost partner ................................................................................................ 16
How to tell right from left..............................................................................16
5
Turning the hearing aid on and off...............................................................17
Putting on and removing the hearing aid................................................... 17
Programs......................................................................................................... 18
The Zen program........................................................................................ 21
Program and sound adjustment..................................................................24
Using a phone with your hearing aids........................................................ 25
PAIRING YOUR HEARING AID AND SMARTPHONE................................... 26
CLEANING................................................................................................ 27
Tools................................................................................................................ 27
Cleaning.......................................................................................................... 27
ACCESSORIES.......................................................................................... 29
TROUBLESHOOTING................................................................................ 30
CERTIFIED POWER ADAPTERS FOR RECHARGEABLE SOLUTIONS........... 32
REGULATORY INFORMATION...................................................................33
Wireless radio transmission......................................................................... 35
EU directives...................................................................................................37
Directive 2014/53/EU................................................................................ 37
Information regarding disposal................................................................38
FCC and ISED statements............................................................................. 38
SYMBOLS................................................................................................. 42
6
YOUR HEARING AID
Welcome
Congratulations on your new hearing aid.
Use your hearing aid regularly, even if it takes some time getting used to it.
Infrequent users don’t usually get the full benefit of a hearing aid.
NOTE
Your hearing aid and its accessories may not look exactly as illustrated in this
booklet. We also reserve the right to make any changes we consider necessary.
Your hearing aid at a glance
The illustration shows your hearing aid without the ear-set. For further information on the ear-set, see the ear-set manual. The ear-set consists of an
earwire and an ear-tip, and it is the part of your hearing aid that you wear
inside your ear.
1. On/off switch
2. Battery drawer with nail grip
Program button
4 3.
3
4. Left/right identification. Blue indicates
your left hearing aid, while red is for
your right hearing aid.
1/2
7
FS model with silver-zinc rechargeable batteries
1. Push button
Battery compartment
3. Earwire
1 2.
3
2
The charger
2
1. Charging slot
2. LED
1
USB cable (to be connected to a certified power
adapter. See the "Certified power adapters for
rechargeable solutions" section).
NOTE
You should only use your charger indoors.
NOTE
Never leave the charger in direct sunlight and do not immerse it in water.
8
Important safety information
Read these pages carefully before you begin using your hearing aid.
Hearing aids and batteries can be dangerous if swallowed or used improperly. Swallowing or improper use can result in severe injury or even
fatalities. In case of ingestion, contact a doctor immediately and call the
24 Hour National Button Battery Ingestion Hotline at (202) 625-3333.
Take your hearing aids out when you are not using them. This will help to
ventilate the ear canal and prevent ear infections.
Contact your doctor or hearing care professional immediately if you suspect you may have an ear infection.
Remove your hearing aids before showering, swimming or using a hair
dryer.
Do not wear your hearing aids when applying perfume, spray, gels, lotion
or cream.
Do not dry your hearing aid in a microwave oven - this will ruin it.
Never use other people’s hearing aids and never allow others to use
yours, as this could damage your hearing.
Never use your hearing aids in environments where there may be explosive gases, such as in mines, etc.
Keep hearing aids, their parts, accessories and batteries away from children and mentally disabled people.
9
Never try to open or repair the hearing aid yourself. Contact your hearing
care professional if you need to have your hearing aid repaired.
Your hearing aids contain radio communication technology. Always observe the environment in which you are using them. If any restrictions apply, you must take precautions to comply with these.
Your hearing aid is very powerful and it can play sounds that exceed a
level of 132 dB. There may therefore be a risk of damaging your remaining hearing.
Do not expose your hearing aids to extreme temperatures or high humidity, and dry them quickly if they get wet, or if you perspire heavily.
Your hearing aids should be stored and transported within the temperature
and humidity ranges of -20°C to +55°C (-4°F to 131°F) and 10%-95% rH.
Your hearing aids are designed to operate within the temperature, humidity
and atmospheric pressure ranges of 0°C (32°F) to 50°C (122°F), 10%-95% rH
and 750 to 1060 mBar.
You can find technical data sheets and additional information on your hearing aids on https://global.widex.com.
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THE HEARING AID
Indications for use
The hearing aids are indicated for individuals older than 36 months with a
range of hearing loss from minimal (10 dB HL) to severe-to-profound (100
dB HL) and all hearing loss configurations.
They are to be programmed by licensed hearing care professionals (audiologists, hearing aid specialists, otolaryngologists) who are trained in hearing
(re)habilitation.
Hearing aids with rechargeable batteries
Hearing aids with rechargeable batteries should NOT be used by children
younger than 4 years of age or mentally disabled people.
Intended use
The hearing aids are intended as air conduction amplification devices to be
used in everyday listening environments. The hearing aids may be equipped
with the Zen program, intended to provide a relaxing sound background
(i.e. music/noise source) for adults who desire to listen to such a background in the quiet.
The zinc-air battery
Use a type 312 zinc-air battery for your hearing aid.
Always use a fresh, new battery that is precisely the kind recommended by
your hearing care professional.
11
NOTE
Check that the battery is completely clean and free of any residue before inserting it in the hearing aid. Otherwise your hearing aid may not function as expected.
Never attempt to recharge a zinc-air hearing aid battery, as it could explode.
Never leave a weak battery in the hearing aids while storing them. It
could leak and ruin your hearing aid.
Dispose of used batteries as indicated on the packaging and take note of
the expiry date.
Low battery indication
When the battery is weak, a sound signal will play. If the battery drains suddenly there may however be no warning. We recommend carrying a spare
battery with you wherever you go.
Changing the battery
To change the battery, do as follows:
Take the adhesive tab off the new battery and make
sure there is no sticky substance left on it. Let it
"breathe" for 60 seconds.
Use the nail grip to gently swing the battery door
open and remove the old battery.
12
Now place the new battery in the drawer as shown.
Close the drawer. If it doesn't close easily, the battery is not placed correctly.
If you are not using the hearing aid for a few days,
remove the battery.
NOTE
Avoid dropping your hearing aid - hold the hearing aid above a soft surface
while changing the battery.
Tamper-resistant battery drawer
If the hearing aid is going to be used by a child or a mentally disabled person, you can ask your hearing care professional to provide it with a tamperresistant battery drawer.
To open battery drawer, use the special tool you've
received, and do as illustrated.
NOTE
This option is not available if your hearing aids use silver-zinc rechargeable
batteries.
The silver zinc battery
Use a type 312 silver-zinc battery for your hearing aid.
13
Always use a new battery supplied by your hearing care professional.
Dispose of used batteries as indicated on the packaging and take note of
the expiry date.
NOTE
Recharge the batteries before using your hearing aids.
NOTE
If you are not going to use your hearing aid for several days, remove the batteries.
NOTE
Your rechargeable batteries should last for approximately one year. Ask your
hearing care professional to change them for you when needed.
Inserting a rechargeable battery
To insert a new rechargeable battery do as follows:
Open the battery compartment.
Now place the battery in the battery compartment
with the golden side facing upwards and close the
battery compartment.
14
NOTE
You can also use a zinc-air battery with your hearing aid.
NOTE
Avoid dropping your hearing aid - hold the hearing aid above a soft surface
while changing the battery.
NOTE
You can also ask your hearing care professional for help if you need to change
the rechargeable battery.
Recharging your hearing aids
Connect the USB cable into the charger and plug it
into the wall socket.
Hold your hearing aid by the earwire and gently
place it on the charging slot.
The green light will start blinking as soon as your
hearing aids start charging.
Once the hearing aids are completely charged, the
green light will stop blinking and it will be solid
green.
15
NOTE
Always charge the silver-zinc batteries at temperatures between 10°C (50°F)
and 40°C (104°F).
NOTE
Once the batteries have been recharged, don't leave the hearing aids on the
charger: the batteries will be drained if the charger is not connected to the power supply. You can't overcharge your silver-zinc batteries.
Sound signals
Your hearing aid plays sounds to inform you that certain features have been
activated or that you have changed program. These sounds can be spoken
messages or tones.
Ask your hearing care professional to turn these sounds off if you don't need
them.
Lost partner
(Only available in selected models)
Your hearing care professional can turn on a feature in your hearing aid that
warns you whenever it loses contact with the hearing aid in the opposite
ear. You will hear a spoken message in your ear.
How to tell right from left
The hearing aid for your right ear has a red mark. The hearing aid for your
left ear has a blue mark.
16
Turning the hearing aid on and off
To turn the hearing aid on, close the battery door. The
hearing aid will play a sound signal to indicate that it is
on, unless your hearing care professional has deactivated this function.
To turn off the hearing aid, pull the battery door
downwards.
NOTE
Don't forget to turn off the hearing aid when it is not in use.
Putting on and removing the hearing aid
Putting on the hearing aid
1. Insert the ear-set in the ear while holding the lower
2
part of the tube/earwire. Pulling the outer ear upwards
and backwards at the same time can be helpful.
2. Then place the hearing aid behind the ear. The hearing
aid should rest comfortably on the ear, close to your
1
head.
Your hearing aid can be fitted using different types of ear-sets. See the separate ear-set manual for more information about your ear-set.
17
Removing the hearing aid
Start by removing the hearing aid from behind the
ear.
Then take the ear-set carefully out of the ear canal
while you hold the lower part of the tube/earwire.
Programs
PROGRAMS
USE
Universal
For everyday use
Quiet
Special program for listening in quiet environments
Comfort
Special program for listening in noisy environments
Transport
For listening in situations with noise from cars,
trains, etc.
Impact
Use this program if you prefer a clear and sharp
sound
Urban
For listening in situations with changing sound
levels (in supermarkets, noisy workplaces or
similar)
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PROGRAMS
USE
Party
For listening in situations with many people talking at the same time
Social
Use this program if you are in small social gatherings, such as family dinners
Music
For listening to music
T
With this program you listen through the hearing aid's telecoil, which allows you to listen directly to the sound without background noise
(requires a teleloop system)
M+T
This program is a combination of the hearing
aid's microphone and the telecoil. You listen to
the sound source, but can also hear other sounds
SPECIAL PROGRAMS
USE
Zen
Plays tones or noise for a relaxing sound background
Phone
This program is designed for listening to phone
conversations
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SMARTTOGGLE PROGRAMS
USE
Zen+
This program is similar to Zen but allows you to
listen to different types of tones or noise
Phone+
This program lets you listen to the phone and
avoid the surrounding sounds. One of your hearing aids transmits the phone conversation to the
other, so that you can listen with both ears
NOTE
The names in the list of programs are the default names. Your hearing care professional can also select an alternative program name from a preselected list.
Then it is even easier for you to select the right program in each listening situation.
NOTE
You can only have one SmartToggle program on your hearing aid.
Depending on your hearing loss, your hearing care professional can activate
the Audibility Extender feature. Ask your hearing care professional if you
could benefit from this.
If your needs and preferences change over time, your hearing care professional can easily change your program selection
20
The Zen program
Your hearing aid may be provided with a unique optional listening program
called Zen. It makes musical tones (and sometimes a rushing noise) in the
background using the latest Fractal technology. These sounds are shaped
according to your hearing loss so you can listen to them at any time and at
any place with a simple push of the program button. The Zen program may
be used alone (without amplification) in quiet when you are not required to
hear surrounding sounds. Or, it may be used with amplification so that both
the surrounding sounds and the generated sounds (fractal tones and noise)
are heard together.
CAUTION
Use of the different Zen programs may interfere with hearing surrounding
sounds including speech. The programs should not be used when hearing such
sounds is important. Switch the hearing aid to a non-Zen program in those situations.
The duration of the Zen play time can be set by your hearing healthcare professional according to your needs.
Benefits
The Zen program may provide a relaxing listening background for some
people. When the Zen program is used in a tinnitus management program,
its wearer may experience some relief from tinnitus.
21
Indications for use
The Zen program is intended to provide a relaxing sound background for
adults (21 years and older) who desire to listen to such a background in quiet. It may be used as a sound therapy tool in a tinnitus treatment program
that is programmed by a licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus
management.
Directions for use
The Zen program can be activated with a simple push of the program button on the hearing aid (or on the remote control). Depending on how your
hearing care professional has set up the program, you can access the Zen
program by a "short-press" of the program button or a "long-press" of the
program button.
● "Short-press" option - the program button is pressed for less than a second. At most two listening programs can be programmed for Zen.
● "Long-press" option - the program button is pressed and held for more
than 1 second. Up to three Zen styles are available. A "short-press" of
the program button in the long-press mode will allow you to cycle
through the available Zen styles. You can exit the "long-press" mode by
pressing and holding the program button for more than one second.
Because of the unique ways in which Zen is programmed in your hearing
aid, please follow the recommendations of your hearing care professionals
as to how to use the program, when to use the program and/ or how long to
use the program.
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Precautions
To ensure the safety and effectiveness of the Zen program when used as a
sound therapy tool for tinnitus, the tinnitus management program must be
designed and conducted by hearing care professionals who are trained in
tinnitus management. A tinnitus management program should include a
complete audiological evaluation, tinnitus diagnosis, counseling, use of
proper amplification and/or sound therapy tools.
Prior to any tinnitus management program, it is advisable that you seek
medical attention to exhaust any medical or surgical treatment options.
Use your hearing aid and the Zen program according to the directions and
schedule recommended by your hearing care professionals.
Contraindications
The following symptoms are contraindicated for the use of hearing aids. Including the Zen program
● Congenital or traumatic deformity of the ear
● Active drainage from the ear within 90 days
● History of rapid progressive hearing loss within previous 90 days
● Acute or chronic dizziness
● Sudden unilateral hearing loss in previous 90 days
Warnings
Use of the Zen program may interfere with hearing everyday sounds including speech. It should not be used when hearing such sounds is important.
Switch the hearing aid to a non-Zen program in those situations.
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Risks
There are no known risks or side effects associated with the use of the Zen
program. However, consistent with our recommendations on the use of
conventional hearing aids, stop using the hearing aids (and the Zen program) and seek attention from your hearing care professional if any of the
following symptoms are noted:
● Skin irritation
● Perceived decrease in loudness, tolerance of sounds, speech not as
clear, or worsening tinnitus
Program and sound adjustment
If you have two hearing aids, the push button can be programmed in several
ways:
As a dedicated program button:
To change programs, just tap the button. To access and exit SmartToggle
programs, push and hold the push button down for more than one second
(this setting is optional). Once you have accessed the SmartToggle program, you can change among the different Zen styles selected for you by
short taps on the button.
As a dedicated sound adjustment button:
Tap the button on your right hearing aid if you’d like more audibility and
more volume. If you need to decrease the volume or you’d like more comfort, tap the button on your left hearing aid.
A long push on either of your hearing aids will mute and unmute the sound
(this setting is optional).
24
As a combined program and sound adjustment button:
If you have this option, tap the button on your right hearing aid if you’d like
more audibility and more volume. If you need to decrease the volume or if
you’d like more comfort, just tap the button on your left hearing aid. A long
push on either of your hearing aids will change programs.
If you only have one hearing aid, a short tap will change programs and a
long tap will allow you to access the SmartToggle programs.
NOTE
You can also use your app for changing programs and adjusting the sound in
your hearing aids.
Using a phone with your hearing aids
When you use a phone, hold it against your head at an angle above your ear, rather than directly against the ear.
25
PAIRING YOUR HEARING AID AND SMARTPHONE
To pair your hearing aids and smartphone you need to restart your hearing
aid. Do as follows:
1. Restart your hearing aids by opening and closing the battery compartment.
2. Keep the hearing aids close to your phone and follow the instructions on
your phone.
3. The hearing aids and smartphone are now ready to use.
NOTE
Your hearing aids are only in pairing mode for three minutes after you restart them. You might need to restart them again if you didn't pair them in
time.
26
CLEANING
Tools
You will receive the following cleaning tools with your hearing aid:
1. Cloth
2. Brush
3. Long wax-removing tool
4. Short wax-removing tool
5. Battery magnet
1.
2. 3. 4. 5.
Cleaning
Cleaning your hearing aid every day will make it more efficient and more
comfortable to wear.
Wipe the hearing aid with a soft cloth (for example
the cloth you received from your hearing care professional).
If the microphone openings are blocked, contact your
hearing care professional.
Dry your hearing aid quickly if it gets wet, or if you perspire heavily. Some
people use a special dehumidifier like Widex PerfectDry Lux to help keep
their hearing aids dry and clean. Ask your hearing care professional if this is
right for you.
27
NOTE
It is recommended to remove the batteries from the hearing aids before placing
the hearing aids in a dehumidifier. Silver-zinc batteries should always be removed from the hearing aid before using any drying system that is 45°C or
warmer.
When not in use leave the battery compartment open to ventilate the hearing aid. For information on how to clean your ear-set, see the ear-set manual.
Do not use any kind of liquid or disinfectant to clean your hearing aid.
Clean and inspect your hearing aid every day after use to check that it is
not broken. If the hearing aid breaks while you are wearing it, leaving
small fragments in your ear canal, contact your doctor. Never try to take
out the fragments yourself.
28
ACCESSORIES
You can use a variety of accessories with your hearing aid. To see
whether you could benefit from using these accessories, ask your
hearing care professional.
Name
Use
RC-DEX
remote control
TV-DEX
for listening to TV and audio
PHONE-DEX 2 for easy landline use
FM+DEX
for streaming audio and FM signals
T-DEX
for connecting hearing aids to mobile phones
via a telecoil
UNI-DEX
for connecting hearing aids to mobile phones
CALL-DEX
for easy wireless connection to mobile phones
COM-DEX
for wireless connection to mobile phones and
other devices via Bluetooth
COM-DEX Refor helping hearing aid users hear speech in difmote Mic
ficult listening situations
Available in some countries only.
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TROUBLESHOOTING
These pages contain advice on what to do if your hearing aid stops working
or if it doesn't work as expected. If the problem persists, contact your hearing care professional.
Problem
Possible cause
Solution
The hearing aid is com- It is not turned on
pletely silent
The battery does not
work
The hearing aid volume Your ear is blocked by
is not powerful enough earwax
Make sure the battery
drawer is completely
closed
Insert a new battery
Contact your doctor
Your hearing may have Contact your hearing
changed
care professional/doctor
The hearing aid whistles Your ear is blocked by
continuously
earwax
Contact your doctor
Your two hearing aids The connection between Turn them off and on
are not working in syn- the hearing aids is lost again
chrony
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Problem
Possible cause
Solution
The hearing aids do not
respond with a corresponding change in volume or program to the
control device
a. The device is used beyond the transmission
range
b. Strong electromagnetic interference in the
vicinity
c. The device and the
hearing aids are not
matched
a. Move the device closer
to the hearing aids.
b. Move away from
known source of EM interference
c. Check with your hearing care professional to
make sure the device is
matched with hearing
aids
You hear “interrupted” a. The battery in one of
speech (on and off)
the hearing aids has exfrom the hearing aids or pired
no speech (muted) from b. Strong electromagthe opposite hearing netic interference in the
aid.
vicinity
a. Replace battery in one
or both hearing aids
b. Move away from
known source of EM interference
NOTE
This information covers only the hearing aid. See the "Ear-sets for Widex hearing aids" user manual for information specific to your ear-set. If the problems
persist, contact your hearing care professional for assistance.
31
CERTIFIED POWER ADAPTERS FOR
RECHARGEABLE SOLUTIONS
Always use one of the certified adapters on the table below to connect your
charger to the power supply:
Manufacturer
Type No.
Kuantech
KSAS0050500100-VUU
KSAS0050500100-VKU
KSAS0050500100-VEU
Kuantech
KSAS0050050D5U
Shenzhen Sunlight Elec- F06AU0500100A
tronic Technology Co Ltd F06AR0500100A
F06BR0500100A
F06CN0500100A
F06JP0500100A
F06KR0500100A
F06US0500100A
F06DE0500100A
Seacomp Displays Inc
HDP-QB05010U
NOTE
If you need more information on adapters for your charger, contact your hearing
care professional.
32
REGULATORY INFORMATION
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.
(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.
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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 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
34
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.
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.
Wireless radio transmission
Wireless functions and operating characteristics
The following tables summarizes the technical details of the wireless technology:
Technical details
Hearing aid Inductive radio
Antenna type
Integral coil antenna
Antenna dimensions
Ø 2 mm, L 5 mm
Modulation
FSK
Magnetic field strength
-54 dBµA/m @ 10 m
Output power (EIRP)
-
Range
0.3 m
35
Technical details
Hearing aid Inductive radio
Center frequency
10.6 MHz
Channel
Single Channel
Bandwith
660 kHz
Data rate
212 kbps
Data flow
Simplex/Semi duplex
Protocol
Random Access / Proprietary
Wireless security measures
Security of the wireless signals is assured through device system design that
includes:
● Individual MAC address for each unit which is checked during each
transmission.
● A built-in pairing table which specifies valid and legitimate pairing
among units
● A proprietary Widex communication protocol which checks the package
numbers during each transmission.
● A Cyclic Redundancy Check (CRC) to check data validity and correct errors.
36
Electromagnetic emissions/immunity standards
The product complies with the following EMC/EMI standards:
Standard
Test type
Note
47 CFR Part 15,
Subpart B
RF emissions
US FCC requirements for
unintentional radiators
47 CFR Part 15,
Subpart C
RF emissions
US FCC requirements for
intentional radiators
IEC 60601-1-2
General EMC including
RF emissions,
RF immunity, ESD
Medical Electrical Equipment, Electromagnetic
compatibility
IEC 60118-13
RF immunity
International standard
for hearing instruments
to ensure adequate immunity radio interference from mobile telephones
EU directives
Directive 2014/53/EU
Hereby, Widex A/S declares that this E-FS is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU.
37
The E-FS contains a radio transmitter operating at 10.6 MHz,-54 dBμA/m
@10 m.
A copy of the Declaration of Conformity according to 2014/53/EU can be
found at:
https://global.widex.com/doc
N26346
Information regarding disposal
Do not dispose of hearing aids, hearing aid accessories and batteries with
ordinary household waste.
Hearing aids, batteries and hearing aid accessories should be disposed of at
sites intended for waste electrical and electronic equipment, or given to
your hearing care professional for safe disposal.
FCC and ISED statements
FCC ID: TTY-UFS
IC: 5676B-UFS
Federal Communications Commission Statement
This device complies with part 15 of the FCC Rules. Operation is subject to
the following two conditions:
(1) This device may not cause harmful interference, and
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(2) this device must accept any interference received, including interference
that may cause undesired operation.
NOTE:
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment 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 equipment and receiver.
— Connect the equipment 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.
NOTE:
This equipment complies with FCC radiation exposure limits set forth for an
uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
39
Changes or modifications to the equipment not expressly approved by Widex could void the user’s authority to operate the equipment.
ISED Statement / Déclaration d’ISED
This device contains licence-exempt transmitter(s)/receiver(s) that comply
with Innovation, Science and Economic Development Canada’s licence-exempt RSS(s). Operation is subject to the following two conditions:
(1) This device may not cause interference.
(2) This device must accept any interference, including interference that
may cause undesired operation of the device.
L’emetteur/recepteur exempt de licence contenu dans le present appareil
est conforme aux CNR d’Innovation, Sciences et Developpement economique Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisee aux deux conditions suivantes:
(1) L’appareil ne doit pas produire de brouillage;
(2) L’appareil doit accepter tout brouillage radioelectrique subi, meme si le
brouillage est susceptible d’en compromettre le fonctionnement.
ISED RADIATION EXPOSURE STATEMENT:
This equipment complies with ISED RF radiation exposure limits set forth for
an uncontrolled environment. This transmitter must not be co-located or
operating in conjunction with any other antenna or transmitter.
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ISED EXPOSITION AUX RADIATIONS:
Cet equipement est conforme avec ISED les limites d’exposition aux
rayonnements defi nies pour un controle environnement. Cet emetteur ne
doit pas etre co-localises ou fonctionner en conjonction avec une autre antenne ou emetteur.
41
SYMBOLS
Symbols commonly used by WIDEX A/S in medical device labelling (labels/IFU/etc.)
Symbol Title/Description
Manufacturer
The product is produced by the manufacturer whose name and address are
stated next to the symbol. If appropriate, the date of manufacture may also
be stated.
Catalogue number
The product’s catalogue (item) number.
Consult instructions for use
The user instructions contain important cautionary information (warnings/precautions) and must be read before using the product.
Warning
Text marked with a warning symbol must be read before using the
product.
WEEE mark
“Not for general waste”. When a product is to be discarded, it must be
sent to a designated collection point for recycling and recovering to
prevent the risk of harm to the environment or human health as a result of the presence of hazardous substances.
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Symbol Title/Description
CE mark
The product is in conformity with the requirements set out in European
CE marking directives.
RCM mark
The product complies with electrical safety, EMC and radio spectrum regulatory requirements for products supplied to the Australian or New Zealand
markets.
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WIDEX A/S
Nymoellevej 6, DK-3540 Lynge, Denmark
https://global.widex.com
Manual no.:
9 514 0430 041 #02
CIB number:
CIB396
9 514 0430 041 02
Issue: 2019-11
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