Widex CROS-FA User Instructions

USER INSTRUCTIONS

CROS-FA model

Behind-the-ear

2

CONTENTS

THEWIDEXCROSTRANSMITTER .................................................

Thebattery ................................................................................................. 

Insertingthebattery ............................................................................. 

Batterydrawerwithoutanailgrip .................................................. 

Rightleftidentification ........................................................................

Positioningthetransmitter ...................................................................

Removingthetransmitter ....................................................................

Turningthetransmitteronandoff .....................................................

Volumeadjustment ................................................................................ 

CLEANING ...................................................................................

Thetransmitter ....................................................................................

INCASEOFMALFUNCTION ........................................................

CARINGFORYOURTRANSMITTER ............................................

WARNINGS ................................................................................

ADVICE .......................................................................................

REGULATORYINFORMATION .....................................................

SYMBOLS ....................................................................................

3

4

THE WIDEX CROS TRANSMITTER

The illustration below shows the WIDEX CROS transmitter without
the ear-set, which consists of a tube and an ear-tip or earmold.
Please refer to the separate ear-set user manual provided.

1. Microphone openings

2. Volume control

3. Program button (transmission on/off)

4. Battery drawer with nail grip

5. On/off switch

1

2

3

4 & 5

5

NOTE
In addition to these user instructions, a separate user manual is

provided describing the various ear-set solutions available for your
transmitter.

WARNING

This booklet and the manual “Ear-sets for Widex BTE hearing aids”
contain important information and instructions. Read these booklets
carefully before you start using the transmitter.

NOTE
Your transmitter and ear-set may not look exactly as illustrated in this

booklet. We also reserve the right to make any changes considered
necessary.

6

Intended use

The transmitter is intended for use as a device that picks up sound
at the ear on which it is worn and transmits it to a hearing aid on
the better ear.

Indications for use

The WIDEX CROS solution is indicated for individuals who are deaf
in one ear and have normal or impaired hearing in the other.

It is to be programmed by licensed hearing care professionals
(audiologists, hearing aid specialists, otolaryngologists) who are
trained in hearing (re)habilitation.

Description of device

The transmitter is worn on the deaf ear like an ordinary “behind­the-ear” hearing aid. It receives sound from the surroundings and
transmits it to a Widex wireless hearing aid worn on the better
ear, via a proprietary wireless technology called WidexLink.

7

The battery

We recommend zinc-air batteries. Use a size 312 battery for the
transmitter.

To obtain replacement batteries, please consult your hearing care
professional. It is important to take note of the expiration date
and the recommendations on the battery pack regarding disposal
of used batteries.

Inserting the battery

Before inserting a new battery, remember to
remove the adhesive tab. Once the tab has been
removed, wait 60 seconds before placing the bat­tery into the transmitter.

8

CAUTION

Do not use batteries if there is a sticky residue from the tab or other
unwanted substance, as this can cause the device to malfunction.

Use the nail grip to gently swing the battery
drawer open.

9

Place the battery in the drawer, so that the plus (+) sign on the
battery faces upward. You can use the battery magnet provided
to steer the battery into place.

If the battery drawer does not close easily, the battery is incorrectly
inserted.

10

Battery drawer without a nail grip

The device may be provided with a battery
drawer without a nail grip. This type of
drawer can be a good choice if the device is
worn by a child. A special tool for opening the
drawer will be included with this drawer.

11

The battery drawer is opened as illustrated

WARNING

Never leave an exhausted battery in the transmitter. Exhausted batter-

ies may leak, damaging the device.

12

Right/left identification

Your transmitter can be provided with a
colored mark for right/left identification
(red mark = right and blue mark = left).

The arrow shows the position of the
identification mark.

Positioning the transmitter

Insert the earpiece in the ear canal while holding the lower part of
the tube. It may help to pull the outer ear backwards and upwards
with the opposite hand.

13

Place the transmitter behind the ear, so that the device and tube
rest comfortably on the ear, close to your head.

The illustrations show an open ear-tip. For further information on
ear-tip/earmold types, anchors and procedures, see the separate
ear-set user manual provided.

14

Removing the transmitter

Remove the transmitter from its position behind the ear.

Carefully pull the earpiece out of the ear canal, while holding the
lower part of the tube. If the earpiece is provided with an extrac­tion cord, take hold of this and carefully pull the ear-tip out of the
ear canal.

15

Turning the transmitter on and off

Close the battery drawer to turn on the trans­mitter.

To turn it off, open the battery drawer slightly
to the first position where a click is felt.

Please remember to turn off the transmitter
when it is not in use. Remove the battery if the
device will not be used for several days.

16

Transmission

With the transmitter turned on, press the program button to start
transmitting sound to the hearing aid on the better ear. Make sure
the hearing aid is also turned on.

To stop transmission, press the program button again. You will
hear a sound when transmission is started, and a message when
transmission is stopped, unless this function has been disabled.

NOTE:

If you have a DEX device, you need to turn off transmission by
pressing the program button in order to use the DEX.

Turn off the transmitter if you want to access different listening
programs in the hearing aid worn on the better ear.

17

Volume adjustment

Your transmitter is provided with a volume control allowing you
to adjust the volume of the sound transmitted to the better ear.

Push the upper part of the volume
control to gradually raise the volume.

Push the lower part to gradually lower
the volume.

+

-

18

CLEANING

The following cleaning accessories are available for the transmit­ter and ear-set*. For cleaning the ear-set, see the user manual
“Ear-sets for Widex BTE hearing aids”.

1. Cloth

2. Wax removing tool

3. Cleaning thread

Contact your hearing care professional if you need additional
supplies of cleaning accessories.

* Selection depends on ear-set type.

19

The transmitter

Clean the device with the soft
cloth after use.

WARNING

Never use water or cleaning solutions to clean the transmitter, as this

may cause it to malfunction.

20

When the transmitter is not in use, keep
it in a warm, dry place with the battery
drawer open, to ventilate the device and
allow it to dry.

21

IN CASE OF MALFUNCTION

Problem Possible cause Solution

The transmitter is
not transmitting

It is not turned on Make sure the battery

drawer is completely
closed

The battery does not
work

Insert a new battery

The program button is
not activated

Press the button

The hearing aid on the
better ear is not
turned on

Turn it on

22

Problem Possible cause Solution

Intermittent
transmission. The
hearing aid
repeatedly
switches to “Mas­ter”

Transmitter battery
level low

Change the battery

Note: This information covers only the transmitter itself. See the
“Ear-sets for Widex BTE hearing aids” user manual for informa­tion specific to your ear-set.

If the problems persist, contact your hearing care professional for
assistance.

23

CARING FOR YOUR TRANSMITTER

The transmitter is a valuable object and should be treated with
care. Here are some things you can do to prolong the life of your
device:

24

CAUTION

• Turn off your transmitter when it is not in use. Remove the battery if
the device will not be used for several days.

• When the transmitter is not in use, keep it in its case in a dry location
out of reach of children and pets.

• Do not expose it to extreme temperatures or high humidity. Make
sure to dry it thoroughly after heavy perspiration such as that which
may occur during intense physical activity, e.g. playing sports.

• Avoid dropping your device – perform cleaning and battery changes
while holding it above a soft surface.

• Do not wear your transmitter while in the shower or swimming, or
when using a hair dryer, perfume, hair and body sprays or gels such
as suntanning lotions or creams.

25

WARNINGS

WARNING

The transmitter and batteries can be dangerous if swal lowed or used
improperly. Swallowing or improper use can result in severe injury or
even fatalities. In case of ingestion, contact a physician immediately
and the 24 Hour National Button Battery Ingestion Hotline at (202)
625-3333.

• Keep the transmitter and its parts and batteries out of reach of

children and anyone else who might swallow such items or otherwise
cause injury to themselves. Do not change batteries in front of them
and do not let them see where you keep your battery supply. Discard
used batteries carefully.

• Batteries are very small and can easily be mistaken for pills or the

like. Never put a battery or device in your mouth for any reason as
you may risk swallowing it.

26

• Risk of explosion if battery is replaced by an incorrect type or
recharged. Dispose of used batteries according to the instructions.

• The device is made of modern non-allergenic materials. Nonetheless,
in rare cases skin irritation may occur. If you notice skin irritation in or
around your ear or ear canal, contact your hearing care professional.

27

WARNING

• Please note that when using the transmitter, you must allow regular

ventilation of the ear. If the ear is not adequately ventilated, there
may be a slightly increased risk of infection or disease in the ear
canal. We therefore recommend that you remove the device and
ear-set from your ear when you go to bed, to allow the ear canal to
be ventilated. If possible, you should also remove your device and
ear-set during the day if there are any periods when you do not need
them. Make sure that you clean and inspect your transmitter and
ear-set as required. If an ear infection or disease occurs, you should
seek medical attention and contact your hearing care professional
for advice on how to disinfect the various device parts. Do not under
any circumstances use alcohol, chlorine or similar substances for this
purpose.

• Regular use of a de-humidifier is recommended to help avoid mal-

function of the device.

28

• Do not use the transmitter in mines or other areas with explosive
gases.

• Do not wear your transmitter during radiation, X-rays, MRIs, CT
or other medical treatments and scans. The emissions from these
procedures as well as from other types of radiation, such as that
in a microwave oven, can damage your device. Radiation from, for
example, room surveillance equipment, burglar alarms and cell
phones is weaker and will not damage the device, but may create
audible interference.

29

WARNING

Interference with active Implants

• In order to show caution, we advise to follow the guidelines recom-

mended by manufacturers of defibrillators and pacemakers regard­ing use of cell phones:

• If you wear an active implantable device keep the Wireless Hearing

Aids and Hearing Aid Accessories such as wireless remote controls
or communicators at least 15 cm/6 inches away from the implant.

• If you experience any interference, do not use the hearing aids and

contact the manufacturer of the implant. Please note that interfer­ence can also be caused by power lines, electrostatic discharge,
airport metal detectors etc.

• If you have an active brain implant, please contact the manufacturer

of the implant for risk evaluation.

If you have an implantable device, we advise to keep magnets* at
least 15 cm/6 inches away from the implant. (*= can be specified as

Autophone magnet, hearing instrument case, magnet in a tool, etc.)

30

CAUTION

• Your transmitter has been tested for interference according to
international standards. Nevertheless, it is possible that unforeseen
interference may occur in the device due to electromagnetic radia­tion from other products such as alarm systems, room surveillance
equipment and cell phones.

• Although your transmitter has been designed to comply with the
most stringent international electromagnetic compatibility stand­ards, the possibility cannot be excluded that it may cause interfer­ence with other equipment, such as medical devices.

• Never try to open or repair the transmitter yourself (To be performed
by authorized personnel only).

31

ADVICE

NOTE

• In most cases, using the transmitter infrequently will not permit you

to gain full benefit from it.

• The use of the transmitter is only part of hearing habilitation and

may need to be supplemented by auditory training and instruction
in lipreading.

• The use of the transmitter increases the risk of accumulation of

earwax. Contact your physician/ENT doctor if you suspect that a
plug of earwax has accumulated in your ear. It is a good idea to ask
your physician to clean your ears a couple of times a year.

32

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
antenna

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

33

Hearing aids RC-DEX TM-DEX Bluetooth* -

NOAHlink

Output
power
(EIRP**)

29 pW 21 nW 1.2 nW +4dB re.

1mW

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 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

34

Hearing aids RC-DEX TM-DEX Bluetooth* -

NOAHlink

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)

Protocol Random

Access – no
collision avoid­ance

Random
Access – no
collision
avoidance

Random Access
– no collision
avoidance

Packet­based 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

35

(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.

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.

36

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.

37

(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

38

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

• 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 fre­quency and bandwidth as the transmitter.

39

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.

40

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 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.

41

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.

42

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.

43

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.

Emissions test Compliance Electromagnetic environment -

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.

44

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

45

Electromagneticimmunity
The DREAM™ series hearing aids are intended for use in the electro-

magnetic 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

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%.

46

Immunity
Test

IEC 60601
Test level

Compliance
level

Electromagnetic
environment –
guidance

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 *)

Surge
IEC
61000-4-5

± 1 kV line(s)
to line(s)

± 2 kV line(s)
to earth

Not
applicable *)

Not
applicable *)

Not
applicable *)

47

Immunity
Test

IEC 60601
Test level

Compliance
level

Electromagnetic
environment –
guidance

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

<5 % U

T

(>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 *)

48

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 U

T

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

level.

*) Battery powered equipment

49

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.

50

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 DREAM

TM

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

√P

51

Radiated RF

IEC
61000-4-3

3 V/m

80 MHz to

2.5 GHz

3 V/m d = 1.2 √P

80 MHz to 800 MHz

d = 2.3 √P
800 MHz to 2.5 GHz

52

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:

53

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 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.

54

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.

Rated maximum

output power of

transmitter (W)

Separation distance according to frequency of

transmitter (m)

150 kHz to 80

MHz

d = 1.2

√P

80 MHz to

800 MHz

d = 1.2 √P

800 MHz to 2.5

GHz

d = 2.3 √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

55

10 3.8 3.8 7.3

100 12 12 23

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.

56

(EMI/EMC Compliance).
The DREAM™ 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
V1.5.1

RF emissions
incl. Spurious
emission

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

IEC 60601-1­2:2007
*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

57

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 C63.19­2007

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.

58

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.

59

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
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.

60

FCC ID: TTY-DFA
IC: 5676B-DFA
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 interfer-

ence 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 par-

61

ticular 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.

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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.

63

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.

64

Hereby, Widex A/S declares that this CROS-FA 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://www.widex.com/doc

65

Electrical and electronic equipment (EEE) contains
materials, components and substances that can be
hazardous and present a risk to human health and
the environment when waste electrical and elec­tronic equipment (WEEE) is not handled correctly.

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. Proper disposal helps to protect human health and the
environment.

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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.

Date of manufacture

The date when the product was manufactured.

Use-by date

The date after which the product is not to be used.

Batch code

The product’s batch code (lot or batch identification).

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Symbol Title/Description

Catalog number

The product’s catalog (item) number.

Serial number

The product’s serial number.*

Keep away from sunlight

The product must be protected from light sources and/or
The product must be kept away from heat

Keep dry

The product must be protected from moisture and/or

The product must be kept away from rain

Lower limit of temperature

The lowest temperature to which the product can be
safely exposed.

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Symbol Title/Description

Upper limit of temperature

The highest temperature to which the product can be
safely exposed.

Temperature limits

The highest and lowest temperatures to which the prod­uct can be safely exposed.

Consult instructions for use

The user instructions contain important cautionary infor­mation (warnings/precautions) and must be read before
using the product.

Caution/Warning

Text marked with a caution/warning symbol must be read
before using the product.

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Symbol Title/Description

WEEE mark
“Not for general waste”

When the product is to be discarded, it must be sent to a
designated collection point for recycling and recovery.

CE mark

The product is in conformity with the requirements set
out in European CE marking directives.

Alert

The product is identified by R&TTE Directive 1999/5/EC as
an equipment Class 2 product with some restrictions on
use in some CE member states.

C-Tick mark

The product complies with EMC and radio spectrum regu­latory requirements for products supplied to the
Australian or New Zealand market.

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Symbol Title/Description

Interference

Electromagnetic interference may occur in the vicinity of
the product.

*The six- or seven-digit number on the product is the serial num­ber. Serial numbers may not always be preceded by

71

Manual no.:

9 514 0260 041 #03
CIB313/0514

WIDEX A/S Nymoellevej 6, DK-3540 Lynge, Denmark
www.widex.com

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