Widex D-PA User Instructions

USER INSTRUCTIONS

THE WIDEX DREAM™ FAMILY

D-PA model

Receiver-in-canal

YOUR HEARING AID

(To be filled out by the hearing care professional)

Your hearing aid series:

PROGRAMS

 Master
 Music
 TV
 Comfort
 Reverse focus
 Phone
 Zen

SPECIAL PROGRAMS

 Master + Zen
 Master + Phone
 Reverse focus

2

SMARTTOGGLE PROGRAMS
 Zen

NOTE

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

3

CONTENTS

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

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

Important safety information.........................................................................7

THE HEARING AID......................................................................................9

Indications for use........................................................................................... 9

Intended use.....................................................................................................9

The battery.......................................................................................................9

Sound signals...................................................................................................11

How to tell right from left..............................................................................12

Turning the hearing aid on and off...............................................................13

Putting on and removing your hearing aid.................................................14

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

Programs.........................................................................................................15

Using a telephone with hearing aids.......................................................... 20

CLEANING.................................................................................................21

Tools.................................................................................................................21

Cleaning...........................................................................................................21

ACCESSORIES.......................................................................................... 23

TROUBLESHOOTING................................................................................ 24

REGULATORY INFORMATION...................................................................26

4

EC directives...................................................................................................47

FCC and IC statements..................................................................................47

SYMBOLS..................................................................................................51

5

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

2

3

1. Microphone openings

2. Battery drawer (on/off function)

3. Nail grip

6

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 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.

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.

7

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.

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.

Storage and transportation up to 60°C (140°F) with 10%-95% rH can be accepted
in shorter periods (duration of max. of 2 weeks).

Your hearing aids are designed to operate from 0°C (32°F) to 50°C (122°F).
For more information about your hearing aids, visit: www.widex.com.

8

THE HEARING AID

Indications for use

The hearing aids are indicated for individuals with a range of hearing loss
from slight (16 dB HL) to moderately severe (up to 85 dB HL) and all hearing
loss configurations.

They are to be programmed be licensed hearing care professionals (audiol­ogists, hearing aid specialists, otolanryngologists) who are trained in hear­ing (re)habilitation and tinnitus management.

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 older than 21 years who desire to listen to
such a background in quiet.

The battery

Use a type 10 zinc-air battery for your hearing aid.
Always use a fresh, new battery that is precisely the kind recommended by

your hearing care professional.

9

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 flat 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.

10

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, you can ask your hearing
care professional to provide it with a tamper-resistant battery door.

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 programs. These sounds may be spoken
messages or tones, depending on your needs and preferences.

Program 1

Message/one short beep

Program 2 Message/two short beeps

11

Program 3 Message/three short beeps
Program 4 Message/one short and one long beep
Program 5 Message/one long beep and two short beeps
Zen+ Message/tone

Ask your hearing care professional to turn these sounds signals off if you
don't need them.

Lost partner

(Only available in 440-series)
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.

12

Turning the hearing aid on and off

To turn the hearing aid on, close the battery drawer.
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, push the battery drawer
downwards.

NOTE

You can also cup the hearing aid in your hand to verify that it is turned on. If it's
on, it will whistle.

Don't forget to turn off the hearing aid when it is not in use.

13

Putting on and removing your hearing aid

To put on your hearing aid:

1

2

1. Insert the ear-set in the ear while holding the
lower part of the tube. 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.

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.

NOTE

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

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.

14

Sound adjustment

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

If you have a remote control, you can also adjust the sound manually, de­pending on your needs and preferences.

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.

You can also mute your hearing aid if you need to. Do as follows:

● Keep pressing the lower part of the volume key on the remote control
until you can hear the steady sound

To turn the sound on again:

● Press the upper part of the volume key or

● Change program

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

Programs

PROGRAMS USE
Master For everyday use

15

PROGRAMS USE
Music For listening to music
TV For listening to the TV
Comfort Attenuates background noise
Reverse focus Focus on sounds from behind.
Phone This program is designed for listening to

phone conversations

Zen Plays tones or noise for a relaxing sound

background

SPECIAL PROGRAMS USE
Compound programs The Master program in one ear and Zen, Re-

verse focus or Phone in the other

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

to listen to different types of tones or noise

NOTE

Not all hearing aids can be used with a remote control.

If your needs change over time, your hearing care professional can easily
change your program selection.

16

Changing programs

To change programs, simply push the program key on your remote control.

Zen+

To access this program, press and hold the program key for more than one
second. A quicker press then allows you to cycle through the available Zen
styles. To exit the program, press and hold down the program key for more
than one second.

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. 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.

17

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 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.

18

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

19

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

Using a telephone with hearing aids

When you use a phone, hold it against your head
at an angle above your ear, rather than directly
against the ear.

20

CLEANING

Tools

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

1. 2. 3. 4. 5.

1. Cloth

2. Brush

3. Long wax removing tool

4. Short wax removing tool

5. Battery magnet

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 still 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 Dry-Go UV to help keep their
hearing aids dry and clean. Ask your hearing care professional if this is right
for you.

21

When not in your ears 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.

22

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 for easy landline use
FM+DEX for streaming audio and FM signals
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
Remote Mic

for helping hearing aid users hear speech in difficult listening
situations

Available in some countries only.

23

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

It is not turned on Make sure the battery

drawer is completely
closed

The battery does not
work

Insert a new battery

The hearing aid volume
is not powerful enough

Your ear is blocked by
earwax

Contact your doctor

Your hearing may have
changed

Contact your hearing
care professional/doctor

The hearing aid whistles
continuously

Your ear is blocked by
earwax

Contact your doctor

Your two hearing aids
are not working in syn­chrony

The connection between
the hearing aids is lost

Turn them off and on
again

24

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 transmitting hearing
aid.

a. The battery in one of
the hearing aids is dead
b. Strong electromag­netic interference in the
vicinity

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

25

REGULATORY INFORMATION

The following Table summarizes the technical details of the WidexLink tech­nology as it is implemented in the DREAM™ hearing aids.

Hearing aids RC-DEX TM-DEX Bluetooth* -

NOAHlink

Antenna type Inductive an-

tenna

Inductive an­tenna

Inductive an­tenna

Embedded
ceramic an­tenna

Antenna di­mensions

Ø1.8 mm,
L - 4.85 mm

Ø8 mm,
L – 20 mm

Ø6 mm,
L - 8 mm

NA

Modulation FSK FSK FSK FHSS/GFSK,

π/4 DPSK, 8
DPSK

Magnetic
Field
Strength (at
10 m distance)

-54 dBμA/m -13 dBμA/m -26 dBμA/m NA

Output power
(EIRP**)

29 pW 21 nW 1.2 nW +4dB re. 1mW

26

Hearing aids RC-DEX TM-DEX Bluetooth* -

NOAHlink

Range < 1 m remote

unit to hear­ing aid
< 30 cm be­tween hearing
aids or Hear­ing aid to TM­DEX

< 1 m remote
unit to hear­ing aid

< 30 cm be­tween hearing
aid and TM­DEX

< 10 m be­tween PC and ­NOAHlink

Center fre­quency

10.6 MHz 10.6 MHz 10.6 MHz 2.4 GHz

Channel Single channel

radio

Single channel
radio

Single channel
radio

5 logical chan­nels

Bandwidth 660 kHz

(-15 dB)

660kHz
(-15 dB)

660kHz
(-15 dB)

1 MHz

Data-rate 212 kbit/sec-

ond (raw
channel ca­pacity)

212 kbit/sec­ond (raw
channel ca­pacity)

212 kbit/sec­ond (raw
channel ca­pacity)

2.1 Mbps

Data flow Simplex or

semi-duplex
capability

Simplex capa­bility

Simplex or
semi-duplex
capability

Time division
duplex (TDD)

27

Hearing aids RC-DEX TM-DEX Bluetooth* -

NOAHlink

Protocol Random Ac-

cess – no colli­sion avoid­ance

Random Ac­cess – no colli­sion avoid­ance

Random Ac­cess – no colli­sion avoid­ance

Packet-based
protocol, time
divided; se­cure Serial
Port Profile
(SPP)

* Bluetooth specification v2.0 + EDR published by the Bluetooth Special In­terest Group (SIG).

** EIRP = Equivalent isotropically radiated power.

Bluetooth Identifier: B01837
Reference number of QPN: NOAHlinkV1.2_412832_QPN_E1
(Benefits) The use of wireless transmission allows convenient and

synchronized control of hearing aid functions. The DREAM wireless hearing
aids share input information between the two partner hearing aids. In so do­ing, the wearers would experience the following additional user benefits
(only when wearing binaural DREAM hearing aids).

Synchronization of volume control settings between hearing aids – The vol­ume in both hearing aids will change when the VC is adjusted on one ear.

Synchronization of listening programs between hearing aids – The same lis­tening program is used in both hearing aids when one is changed by the
user.

28

Surveillance of partner hearing aid – The hearing aid(s) will signal an alert
(“partner check”) when a hearing aid battery has expired, or that one of the
hearing aids has fallen off. In rare instances, a much stronger wireless source
nearby may activate this alert. This serves as an early warning to the wearer
of such service interruption.

Coordination of compression – The DREAM hearing aids maintain the inten­sity level difference between ears (inter-aural level difference, ILD). In some
situations where speech is presented to one side and noise the other side,
this coordinated action could enhance the relative loudness of the speech
sounds to the noise background and improve speech understanding for
some wearers.

More accurate identification of feedback – The DREAM hearing aids distin­guish between “true” hearing aid whistling (or feedback) and music sounds
to prevent unnecessary feedback cancellation and preserve natural sound
quality.

Radio transmitter / cables / transducers
The DREAM™ series hearing aid contains a radio transmitter / receiver with

the following
Radio transmitter parameters:
Frequency (range): 10.6 MHz (10.2 – 11.0 MHz)
Bandwidth (-15dB): 660 kHz
Channel: Single channel radio
Modulation: FSK

29

Radiated output power: 29 pW / -75 dBm
Magnetic field strength: -54 dBμA/m @ 10 m
Duty Cycle: < 5 % (averaged over 1 hour of operation)
Simplex or semi duplex capability
The radio receiver in the DREAM™ series hearing aid is using the same fre-

quency and bandwidth as the transmitter.

Cables and transducers:

No cables and transducers are used neither during normal use of the
DREAM™ series hearing aid nor during programming of the hearing aid.

Quality of Service for Wireless Technology in the WidexLink System

WidexLink wireless technology enables communication between two part­ners of a binaural pair of DREAM hearing aids and with their matched exter­nal devices. The requirements for the quality of service (QoS) vary among
the various components and their intended user scenarios.

For programming, these requirements include a BER (Bit Error Rate) better
than 10-3, at a bitrate of 212 kbits/s, a semi-duplex transmission with a re­quired acknowledge, a transmission latency in each direction (2x) and a re­ceive-to-transmit mode (RX to TX) time. The data are saved in the hearing
aid even when transmission is interrupted.

During daily use, the requirements on audio streaming between hearing
aids include a BER better than 10-3. The communication is simplex with a
bitrate of 212 kbits/s. The additional audio decoding in this mode results in a
longer latency which is less than 10 ms. For remote control commands the

30

QoS requirements include a BER better than 10-2. The lower BER require­ment results from redundant transmissions. Each key press results in trans­missions of 7 data packages of which only one is needed for a successful
communication.

For inter-ear communication between hearing aids, a BER better than 10-3
is required. The communication is updated every 50 ms (or 20 Hz). The
hearing aids continue to amplify based on the last saved settings even when
the transmission range is exceeded or when communication is interfered.

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.
Guidance and manufacturer’s declaration
Electromagnetic emissions
The DREAM™ series hearing aids are intended for use in the electromagnetic

environment specified below. The customer or the user of a DREAM™ series
hearing aid should assure that it is used in such an environment.

31

Emissions test Compliance Electromagnetic envi-

ronment ­guidance

RF emissions
CISPR 11

Group 1 The DREAM™ hearing

aid uses RF energy only
for its internal function.
Therefore, its RF emis­sions are very low and
are not likely to cause
any interference in near­by electronic equip­ment.

RF emissions
CISPR 11

Class B The DREAM™ hearing

aid is suitable for use in
all establishments, in­cluding domestic estab­lishments and those di­rectly connected to the
public low‑voltage pow­er supply network that
supplies buildings used
for domestic purposes.

Harmonic emissions
IEC 61000-3-2

Not
applicable *)

Voltage fluctuations/
flicker emissions IEC
61000-3-3

Not
applicable *)

*) Battery powered equipment
Electromagnetic immunity

32

The DREAM™ series hearing aids are intended for use in the electromagnetic
environment specified below. The customer or the user of a DREAM™ series
hearing aid should assure that it is used in such an environment.

Immunity Test IEC 60601

Test level

Compliance level Electromagnetic

environment –
guidance

Immunity Test IEC 60601

Test level

Compliance level Electromagnetic

environment –
guidance

Electrostatic dis­charge (ESD)
IEC
61000-4-2

± 6 kV contact
± 8 kV air

± 6 kV contact
± 8 kV air

Floors should be
wood, concrete or
ceramic tile. If
floors are covered
with synthetic
material, the rela­tive humidity
should be at least
30%.

Electrical fast
transients/burst
IEC
61000-4-4

± 2 kV for power
line supplies
± 1 kV for input/
output lines

Not
applicable *)

Not
applicable *)

Not
applicable *)

33

Immunity Test IEC 60601

Test level

Compliance level Electromagnetic

environment –
guidance

Surge
IEC
61000-4-5

± 1 kV line(s) to
line(s)

± 2 kV line(s) to
earth

Not
applicable *)

Not
applicable *)

Not
applicable *)

Voltage dips,
short interrup­tions and voltage
variations on
power supply in­put lines
IEC
61000-4-11

<5 % UT
(>95 % dip
in UT) for

0.5 cycle
40 % UT
(60 % dip
in UT) for 5 cycles
70 % UT
(30 % dip
in UT) for 25 cy­cles
<5 % UT
(>95 % dip
in UT) for 5 s

Not
applicable *)

Not
applicable *)

34

Immunity Test IEC 60601

Test level

Compliance level Electromagnetic

environment –
guidance

Power frequency
(50/60 Hz) mag­netic field
IEC
61000-4-8

3 A/m 3 A/m Power frequency

magnetic fields
should be at lev­els characteristic
of a typical loca­tion in a typical
commercial or
hospital environ­ment

NOTE UT is the a.c. mains voltage prior to the application of the test level.

*) Battery powered equipment
Electromagnetic immunity – cont.
The DREAM™ series hearing aids are intended for use in the electromagnetic

environment specified below. The customer or the user of a DREAM™ series
hearing aid should assure that it is used in such an environment.

35

Immunity Test IEC 60601

Test level

Compliance level Electromagnetic

environment –
guidance

Portable and mo­bile RF communi­cations equip­ment should be
used no closer to
any part of the
DREAMTM series
hearing aid, in­cluding cables,
than the recom­mended separa­tion distance cal­culated from the
equation applica­ble to the fre­quency of the
transmitter.

36

Immunity Test IEC 60601

Test level

Compliance level Electromagnetic

environment –
guidance

Conducted RF

IEC
61000-4-6

3 Vrms

150 kHz to 80
MHz

3 Vrms

Recommended
separation dis­tance
d = 1.2 ÖP

Radiated RF

IEC
61000-4-3

3 V/m

80 MHz to 2.5
GHz

3 V/m d = 1.2 ÖP

80 MHz to 800
MHz

d = 2.3 ÖP
800 MHz to 2.5
GHz

Immunity Test IEC 60601

Test level

Compliance level Electromagnetic

environment –
guidance

37

Immunity Test IEC 60601

Test level

Compliance level Electromagnetic

environment –
guidance

Where P is the
maximum output
power rating of
the transmitter in
watts (W) accord­ing to the trans­mitter manufac­turer and d is the
recommended
separation dis­tance in meters
(m).

Field strengths
from fixed RF
transmitters, as
determined by an
electromagnetic
site survey a,
should be less
than the compli­ance level in each
frequency range
b.

38

Immunity Test IEC 60601

Test level

Compliance level Electromagnetic

environment –
guidance

Interference may
occur in the vicini­ty of equipment
marked with the
following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, ob­jects and people.

39

Immunity Test IEC 60601

Test level

Compliance level Electromagnetic

environment –
guidance

a. Field strengths from fixed transmitters, such as base stations
for radio (cellular/cordless) telephones and land mobile radios, amateur ra­dio, AM and FM radio broadcast and TV broadcast cannot be predicted the­oretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the DREAM™ series
hearing aid is used exceeds the applicable RF compliance level above, the
DREAM™ series hearing aid should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessa­ry, such as re-orienting or re-locating the DREAM™ series hearing aid.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be
less than 3 V/m.

Recommended separation distances

Recommended separation distances between portable and mobile RF com­munication equipment and the DREAM™ series hearing aids.

The DREAM™ series hearing aids are intended for use in the electromagnetic
environment in which RF disturbances are controlled. The customer or the
user of the DREAM™ series hearing aid can help prevent electromagnetic in­terference by maintaining a minimum distance between portable and mo­bile RF communications equipment (transmitters) and the DREAM™ hearing
aids as recommended below, according to the maximum output power of
the communications equipment.

40

Rated maximum
output power of
transmitter
(W)

Separation distance according to frequency of transmit­ter (m)

150 kHz to 80
MHz
d = 1.2 ÖP

80 MHz to 800
MHz
d = 1.2 ÖP

800 MHz to 2.5
GHz
d = 2.3 ÖP

0.01

0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

41

Rated maximum
output power of
transmitter
(W)

Separation distance according to frequency of transmit­ter (m)

For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, ob­jects and people.

This DREAM™ hearing aid may be interfered with by other equipment even
if that other equipment complies with CISPR emission requirements.

(EMI/EMC Compliance).
The DREAM™ hearing aid complies with the following EMC/EMI standards:

42

Standard Test type Note
47 CFR Part 15, subpartCRF emissions USA Federal Communi-

cations Commission
(FCC) requirements for
intentional radiators.

EN 300 330-2
V1.5.1

RF emissions incl. Spuri­ous emission

EMC and radio spectrum
matters for Short Range
Devices in the frequency
range 9 kHz – 25 MHz

IEC 60601-1-2:2007
*adapted protocol

EMC emission
Immunity, RF and ESD

Medical electrical equip­ment.
General requirements
for basic safety and es­sential performance.
Electromagnetic com­patibility.

EN 301 489-3 V1.4.1 Immunity, RF and ESD Standard for Low Power

Transmitters in the fre­quency range 9 kHz –
40 GHz

43

Standard Test type Note
IEC 60118-

13:2011

Immunity
RF Near Field immunity
test

International Product
std. for hearing aids to
ensure adequate im­munity to radio interfer­ence from cell tele­phones.

ANSI C63.19-2007 Immunity

RF Near Field immunity
test

American National
Standard Methods of
measurement of Com­patibility between wire­less Communication De­vices and Hearing Aids

* The device was tested in only one orientation that represents the longest
length (or worst case scenario). This is acceptable because of the relative
small size of the device compared to the wavelength of the RF used in the
test.

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:

44

(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 se-

lecting 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.

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.

45

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
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

46

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.

EC directives

Directive 1999/5/EC

Hereby, Widex A/S declares that this D-PA is in compliance with the essen­tial requirements and other relevant provisions of Directive 1999/5/EC.

A copy of the Declaration of Conformity can be found at: http://wi-

dex.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 IC statements

FCC ID: TTY-DPA
IC: 5676B-DPA

47

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. 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.

48

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.

Industry Canada Statement / Déclaration d’industrie Canada
Under Industry Canada regulations, this radio transmitter may only operate

using an antenna of a type and maximum (or lesser) gain approved for the
transmitter by Industry Canada.

To reduce potential radio interference to other users, the antenna type and
its gain should be so chosen that the equivalent isotropically radiated power
(e.i.r.p.) is not more than that necessary for successful communication.

This device complies with Industry Canada licence-exempt RSS standard(s).
Operation is subject to the following two conditions:

(1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may

cause undesired operation of the device.
Conformément à la réglementation d’Industrie Canada, le présent émetteur

radio peut fonctionner avec une antenne d’un type et d’un gain maximal (ou
inférieur) approuvé pour l’émetteur par Industrie Canada.

49

Dans le but de réduire les risques de brouillage radioélectrique à l’intention
des autres utilisateurs, il faut choisir le type d’antenne et son gain de sorte
que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas l’in­tensité nécessaire à l’établissement d’une communication satisfaisante.

Le présent appareil est conforme aux CNR d’Industrie Canada applicables
aux appareils radio exempts de licence. L’exploitation est autorisée aux
deux conditions suivantes :

(1) l’appareil ne doit pas produire de brouillage, et
(2) l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique

subi, même si le brouillage est susceptible d’en compromettre le fonc­tionnement.

50

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.

Catalog number

The product’s catalog (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.

51

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 market.

Interference

Electromagnetic interference may occur in the vicinity of the
product.

52

53

54

55

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

www.widex.com

Manual no.:

9 514 0219 041 #05

CIB number:

CIB289/0117
Issue: 2017-01

9 514 0219 041 #05