Widex u-pa User Instructions

USER INSTRUCTIONS

THE WIDEX UNIQUE™ FAMILY

U-PA model

Receiver-in-canal

YOUR WIDEX® HEARING AID

(To be filled out by the hearing care professional)

Your hearing aid series:

PROGRAM

 Universal  Audibility Extender
 Quiet  Audibility Extender
 Transport  Audibility Extender
 Urban  Audibility Extender
 Party  Audibility Extender
 Music  Audibility Extender

SPECIAL PROGRAMS

 Zen  Audibility Extender
 Phone  Audibility Extender

SMARTTOGGLE PROGRAMS
 Zen+  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.

2

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.........................................................................................................16

Using a phone with hearing aids..................................................................18

CLEANING............................................................................................. 19

Tools.................................................................................................................19

Cleaning the hearing aid................................................................................19

ACCESSORIES........................................................................................21

TROUBLESHOOTING.............................................................................22

REGULATORY INFORMATION...............................................................24

4

FCC and IC statements...................................................................................41

EC directives...................................................................................................43

SYMBOLS..............................................................................................45

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 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 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 wireless 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 sound automatically according to your sound
environment.

If you have a remote control, 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 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 canceled when you turn off your
hearing aid or if you change program.

15

Programs

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

ments

Transport For listening in situations with noise from cars,

trains, etc.

Urban For listening in situations with changing sound

levels (in supermarkets, noisy workplaces or sim­ilar)

Party For listening in situations with many people talk-

ing at the same time

Music For listening to music

SPECIAL PROGRAMS USE
Zen Plays tones or noise for a relaxing sound back-

ground. For more information, see under "The
Zen program"

Phone This program is designed for listening to phone

conversations

16

SMARTTOGGLE PRO­GRAMS

USE

Zen+ This program is similar to Zen but allows you to

listen to different types of tones or noise

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.

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

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.

17

Indication for use

The Zen program is intended to provide a relaxing sound background (i.e.,
music/noise source) for adults 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 prescribed by a hearing care professional (audiologists, hearing
aid specialists, otolaryngologists) who is trained in tinnitus management.

Directions for use

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.

CAUTION

If you perceive a decrease in loudness, tolerance of sounds, speech not as
clear, or worsening tinnitus, contact your hearing care professional.

Using a phone 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.

18

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 the hearing aid

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.

19

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.

20

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

Available in some countries only.

21

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

22

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.

23

REGULATORY INFORMATION

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

Hearing aids RC-DEX TM-DEX Bluetooth* -

NOAHlink

Antenna
type

Inductive antenna Inductive an-

tenna

Inductive anten-naEmbedded

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

24

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
TM-DEX

< 1 m remote
unit to hearing
aid

< 30 cm be­tween hearing
aid and TM-DEX

< 10 m be­tween PC and
NOAHlink

Center fre­quency

10.6 MHz 10.6 MHz 10.6 MHz 2.4 GHz

Channel Single channel ra-

dio

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/second

(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)

25

Hearing aids RC-DEX TM-DEX Bluetooth* -

NOAHlink

Protocol Random Access –

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 UNIQUE 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 UNIQUE 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.

26

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 UNIQUE 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 UNIQUE hearing aids distinguish
between “true” hearing aid whistling (or feedback) and music sounds to prevent
unnecessary feedback cancellation and preserve natural sound quality.

(Contraindications):

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

following

27

Radio transmitter parameters:

Frequency (range): 10.6 MHz (10.2 – 11.0 MHz)
Bandwidth (-15dB): 660 kHz
Channel: Single channel radio
Modulation: FSK
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 UNIQUE™ series hearing aid is using the same frequency

and bandwidth as the transmitter.

Cables and transducers:

No cables and transducers are used neither during normal use of the UNIQUE™
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 UNIQUE 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.

28

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 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.

29

Guidance and manufacturer’s declaration

Electromagnetic emissions
The UNIQUE™ series hearing aids are intended for use in the electromagnetic en-

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

Emissions test Compli-

ance

Electromagnetic environment - guidance

RF emissions
CISPR 11

Group 1 The UNIQUE™ 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 UNIQUE™ hearing aid is suitable for use in all es-

tablishments, 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

30

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

Immunity Test IEC 60601

Test level

Compliance

level

Electromagnetic en-

vironment – guid-

ance

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 *)

31

Immunity Test IEC 60601

Test level

Compliance

level

Electromagnetic en-

vironment – guid-

ance

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 *)

32

Immunity Test IEC 60601

Test level

Compliance

level

Electromagnetic en-

vironment – guid-

ance

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

Immunity Test IEC 60601

Test level

Compliance
level

Electromagnetic environ­ment – guidance

33

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

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

34

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.

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

35

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.

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 UNIQUE™ series hearing aid is used ex­ceeds the applicable RF compliance level above, the UNIQUE™ 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 UNIQUE™ 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 UNIQUE™ series hearing aids.

The UNIQUE™ series hearing aids are intended for use in the electromagnetic en­vironment in which RF disturbances are controlled. The customer or the user of
the UNIQUE™ series hearing aid can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communica-

36

tions equipment (transmitters) and the UNIQUE™ hearing aids as recommended
below, according to the maximum output power of the communications equip­ment.

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

37

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

(EMI/EMC Compliance).

The UNIQUE™ hearing aid complies with the following EMC/EMI standards:

Standard Test type Note
47 CFR Part 15,

subpart C

RF emissions USA Federal Communications Commission

(FCC) requirements for intentional radiators.

EN 300 330-2
V1.6.1

RF emissions
incl. Spurious
emission

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

38

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
V1.6.1

Immunity, RF
and ESD

Standard for Low Power Transmitters in the
frequency range 9 kHz – 40 GHz

IEC 60118­13:2011

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.

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.

39

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

40

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.

FCC and IC statements

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

41

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 un-

controlled 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.

42

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.

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.

EC directives

Directive 1999/5/EC

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

43

A copy of the Declaration of Conformity according to 1999/5/EC can be
found at:

http://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.

44

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.

45

Symbol Title/Description

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.

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.

46

47

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

www.widex.com

Manual no.:

9 514 0318 041 #02

CIB number:

CIB349
Issue: 2016-07

9 514 0318 041 #02