Widex EBB3D User Instructions

USER INSTRUCTIONS

THE WIDEX EVOKE™ FAMILY

EBB3D model

BTE

(Behind-the-ear)

YOUR HEARING AID

(To be filled out by the hearing care professional)

Your hearing aid series:

PROGRAMS

 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

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SPECIAL PROGRAMS

 Zen  Audibility Extender
 Phone  Audibility Extender

SMARTTOGGLE PROGRAMS
 Zen+  Audibility Extender

NOTE

The description and use of the Phone program in this user guide refer only to
normal phone conversations, not phone conversations using direct streaming
from your smartphone.

NOTE

Read this booklet and the booklet "Ear-sets for Widex hearing aids" carefully
before you start using your hearing aid.

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: global.widex.com/EVOKE.

This hearing aid works wirelessly with the EVOKE app. We take no responsibility
if the hearing aid is used with any third party app or if the EVOKE app is used
with any unsupported devices.

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CONTENTS

YOUR HEARING AID...................................................................................6

Welcome...........................................................................................................6

Your hearing aid at a glance.......................................................................6

Important safety information.........................................................................8

Operating conditions...................................................................................9

Storage and transportation conditions....................................................10

THE HEARING AID..................................................................................... 11

Indications for use........................................................................................... 11

Intended use.................................................................................................... 11

The battery.......................................................................................................11

Low battery indication............................................................................... 12

Changing the battery................................................................................. 12

Tamper-resistant battery drawer.............................................................13

Sound signals..................................................................................................13

Lost partner ................................................................................................14

How to tell right from left..............................................................................14

Turning the hearing aid on and off.............................................................. 14

Putting on and removing the hearing aid...................................................15

Sound adjustment..........................................................................................15

Programs.........................................................................................................17

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The Zen program........................................................................................19

Program adjustment..................................................................................... 22

Using a phone with your hearing aids........................................................ 23

PAIRING YOUR HEARING AID AND SMARTPHONE...................................24

COMPATIBILITY WITH SMARTPHONES......................................................24

CLEANING................................................................................................25

Tools................................................................................................................25

Cleaning..........................................................................................................25

ACCESSORIES.......................................................................................... 27

TROUBLESHOOTING................................................................................ 28

REGULATORY INFORMATION.................................................................. 30

EU directives...................................................................................................32

Directive 2014/53/EU................................................................................ 32

Information regarding disposal................................................................33

FCC and ISED statements.............................................................................33

SYMBOLS.................................................................................................36

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YOUR HEARING AID

3

4 + 5

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1

1

7

6

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 a
tube and an ear-tip or earmould, and it is the part of your hearing aid that
you wear inside your ear.

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1. Microphone openings

2. Volume control

3. Program button

4. Battery lid with nail grip

5. On/off switch

6. Hook

7. Left/right identification.
Blue indicates your left
hearing aid, while red is for
your right hearing aid.

NOTE

Please note that the hook is fixed to the hearing aid and should not be removed.

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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 [phone].

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 or an allergic reaction.

Contact your hearing care professional if the hearing aid doesn't feel
comfortable, or if it doesn't fit properly, causing irritation, redness or the
like.

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.

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Keep hearing aids, their parts, accessories and batteries away from chil­dren and mentally disabled people.

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.

Please note that streaming sound to your hearing aids at a high volume
can prevent you from hearing other important sounds such as alarms
and traffic noise. In such situations make sure to keep the volume of the
streamed sound at a suitable level.

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.

Operating conditions

Your hearing aid has been designed to operate in everyday situations, and it
works in environmental conditions that are comfortable for you. You can
wear your hearing aid during flights, but you should remove it before show­ering or swimming.

The specific operating conditions for your hearing aid are listed below:

Minimum

Temperature 0°C (32°F) 50°C (122°F)

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Maximum

Minimum Maximum
Humidity 10% rH 95% rH
Atmospheric pressure 750 mbar 1060 mbar

Storage and transportation conditions

Your hearing aid is sensitive to extreme conditions such as high tempera­ture. See the specific storage and transportation conditions below:

Minimum Maximum
Temperature -20°C (-4°F) 55°C (131°F)
Humidity 10% rH 95% rH

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 with a range of hearing loss
from minimal (10 dB HL) to severe-to-profound (105 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.

For individuals younger than 36 months, the following limitations apply:

● A standard hook and a custom earmold must be used.

● A tamper-resistant battery drawer must be used.

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 battery

Use a type 13 zinc-air battery for your hearing aid.
Always use a fresh, new battery that is precisely the kind recommended by

your hearing care professional.

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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 your hearing aid batteries, as they could ex­plode.

Never leave a dead 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.

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Now place the new battery in the drawer as shown.

Close the drawer. If it doesn't close easily, the bat-

tery 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.

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.

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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.

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.

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Putting on and removing the hearing aid

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2

Putting on the hearing aid

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.

Removing the hearing aid

1. Insert the ear-set in the ear while holding the lower
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
head.

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.

Sound adjustment

Your hearing aid adjusts the sound automatically according to your sound
environment.

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You can also adjust the sound manually to achieve more comfort or more
audibility, depending on your needs and preferences. For more information
on how this works, consult your hearing care professional.

Depending on the hearing aid settings and features, any sound adjustment
you make will affect both hearing aids.

Each time you operate the volume control, you will hear a beep-tone unless
your hearing care professional has deactivated this function. When you
reach the maximum or minimum setting, you will hear a steady tone.

To mute your hearing aid do as follows:

● Keep pressing the lower part of the volume control until you can hear

the steady sound

To turn the sound on again:

● Press the upper part of the volume control or

● Change program

Any adjustment of the volume will be canceled when you turn off your
hearing aid or if you change program.

NOTE

You can also use your app for changing programs and adjusting the sound in
your hearing aids.

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Programs

PROGRAMS USE
Universal For everyday use
Quiet Special program for listening in quiet envi-

Comfort Special program for listening in noisy envi-

Transport For listening in situations with noise from

Impact Use this program if you prefer a clear and

Urban For listening in situations with changing

Party For listening in situations with many people

Social Use this program if you are in small social

Music For listening to music

ronments

ronments

cars, trains, etc.

sharp sound

sound levels (in supermarkets, noisy work­places or similar)

talking at the same time

gatherings, such as family dinners

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PROGRAMS USE
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

SMARTTOGGLE PROGRAMS USE
Zen+ This program is similar to Zen but allows you

to listen to different types of tones or noise

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.

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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.

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.

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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.

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 sec-

ond. 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.

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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.

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

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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.

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 adjustment

To change programs, just press the program button. To access and exit the
SmartToggle program, press 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 presses on the button.

NOTE

You can also use your app for changing programs and adjusting the sound in
your hearing aids.

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Using a phone with your hearing aids

When speaking on the phone, hold the phone against your head at an angle above your ear, rather than directly against the ear.

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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 compart-

ment.

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.

COMPATIBILITY WITH SMARTPHONES

You can see a list of compatible smartphones, tablets, etc, at: http://global.widex.com

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CLEANING

1. 2. 3. 4. 5.

Tools

You will receive the following cleaning tools with your hearing aid:

Cleaning

Cleaning your hearing aid every day will make it more efficient and more
comfortable to wear.

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.

1. Cloth

2. Brush

3. Long wax-removing tool

4. Short wax-removing tool

5. Battery magnet

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.

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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.

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ACCESSORIES

You can use various accessories with your hearing aid. Ask your hearing
care professional to find out if you can benefit from these.

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 tele-

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 de-

COM-DEX Re­mote Mic

TV PLAY for direct TV streaming
EVOKE APP for using your smartphone to control your hearing aids
Available in some countries only.

coil

vices via Bluetooth
for helping hearing aid users hear speech in difficult lis-

tening situations

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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-

pletely silent

The hearing aid volume
is not powerful enough

The hearing aid whistles
continuously

Your two hearing aids
are not working in syn­chrony

It is not turned on Make sure the battery

The battery does not
work

Your ear is blocked by
earwax

Your hearing may have
changed

Your ear is blocked by
earwax

The connection between
the hearing aids is lost

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drawer is completely
closed

Insert a new battery

Contact your doctor

Contact your hearing
care professional/doctor

Contact your doctor

Turn them off and on
again

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”
speech (on and off)
from the hearing aids or
no speech (muted) from
the opposite hearing
aid.

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.

a. The battery in one of
the hearing aids has ex­pired
b. Strong electromag­netic interference in the
vicinity

a. Replace battery in one
or both hearing aids
b. Move away from
known source of EM in­terference

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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

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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.

EU directives

Directive 2014/53/EU

Hereby, Widex A/S declares that this EBB3D is in compliance with the es­sential requirements and other relevant provisions of Directive 2014/53/EU.
The EBB3D contains radio transmitters operating at: 10.6 MHz, -54 dBµA/m
@10 m, 2.4 GHz, 0.9 mW EIRP.

A copy of the Declaration of Conformity according to 2014/53/EU can be
found at:

https://global.widex.com/doc

N26346

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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-EBB3D IC: 5676B-EBB3D

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
(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. How-

33

ever, 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.

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.

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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.

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.

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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.

36

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.

373839

WIDEX A/S Nymoellevej 6, DK-3540 Lynge, Denmark

https://www.global.widex.com

Manual no.:

9 514 0529 041 #01

CIB number:

CIB410/0419
Issue: 2019-07

9 514 0529 041 01