Widex | D-m CB | User Instructions | Widex D-m CB User Instructions

Widex D-m CB User Instructions
USER INSTRUCTIONS
THE WIDEX DREAM™ FAMILY
D-m CB model
Behind-the-ear
YOUR HEARING AID
(To be filled out by the hearing care professional)
Your hearing aid series:
PROGRAMS
 Master
 Music
 TV
 Comfort
 Phone
 Zen
SPECIAL PROGRAMS
 Master + Zen
 Master + Phone
SMARTTOGGLE PROGRAMS
 Zen+
 Phone+
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
Your hearing aid at a glance.......................................................................6
Important safety information.........................................................................7
THE HEARING AID......................................................................................9
Indications for use........................................................................................... 9
Intended use.....................................................................................................9
The battery....................................................................................................... 9
Low battery indication...............................................................................10
Changing the battery................................................................................. 10
Sound signals...................................................................................................11
Lost partner ................................................................................................ 12
How to tell right from left..............................................................................12
Turning the hearing aid on and off...............................................................12
Putting on and removing your hearing aid.................................................13
Sound adjustment..........................................................................................14
Programs......................................................................................................... 15
Changing programs....................................................................................16
The Zen program........................................................................................ 16
Using a telephone with hearing aids.......................................................... 20
4
CLEANING.................................................................................................21
Tools.................................................................................................................21
Cleaning........................................................................................................... 21
ACCESSORIES.......................................................................................... 23
TROUBLESHOOTING................................................................................ 24
REGULATORY INFORMATION...................................................................26
EC directives...................................................................................................47
Directive 2014/53/EU................................................................................ 47
Information regarding disposal................................................................47
FCC and IC statements..................................................................................48
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. Microphone openings
1
2. Nail grip with on/off function
3. Right/left identification
2
3
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 call the
24 Hour National Button Battery Ingestion Hotline at (202) 625-3333.
Take your hearing aids out when you are not using them. This will help to
ventilate the ear canal and prevent ear infections.
Contact your doctor or hearing care professional immediately if you suspect you may have an ear infection or an allergic reaction.
Contact your hearing care professional if the hearing aid doesn't feel
comfortable, or if it doesn't fit properly, causing irritation, redness or the
like.
Remove your hearing aids before showering, swimming or using a hair
dryer.
Do not wear your hearing aids when applying perfume, spray, gels, lotion
or cream.
Do not dry your hearing aid in a microwave oven - this will ruin it.
Never use other people’s hearing aids and never allow others to use
yours, as this could damage your hearing.
Never use your hearing aids in environments where there may be explosive gases, such as in mines, etc.
7
Keep hearing aids, their parts, accessories and batteries away from children and mentally disabled people.
Never try to open or repair the hearing aid yourself. Contact your hearing
care professional if you need to have your hearing aid repaired.
Your hearing aids contain radio communication technology. Always observe the environment in which you are using them. If any restrictions apply, you must take precautions to comply with these.
Your hearing aid is very powerful and it can play sounds that exceed a
level of 132 dB. There may therefore be a risk of damaging your remaining hearing.
Do not expose your hearing aids to extreme temperatures or high humidity, and dry them quickly if they get wet, or if you perspire heavily.
Your hearing aids should be stored and transported within the temperature
and humidity ranges of -20°C to +55°C (-4°F to 131°F) and 10%-95% rH.
Your hearing aids are designed to operate within the temperature, humidity
and atmospheric pressure ranges of 0°C (32°F) to 50°C (122°F), 10%-95% rH
and 750 to 1060 mBar.
You can find technical data sheets and additional information on your hearing aids on https://global.widex.com.
8
THE HEARING AID
Indications for use
The FASHION POWER model is indicated for individuals with a range of
hearing loss from minimal (10 dB HL) to severe-to-profound (90 dB HL) and
all hearing loss configurations.
They are to be programmed by licensed hearing care professionals (audiologists, hearing aid specialists, otolaryngologists) who are trained in hearing
(re)habilitation.
Intended use
The hearing aids are intended as air conduction amplification devices to be
used in everyday listening environments. The hearing aids may be equipped
with the Zen program, intended to provide a relaxing sound background
(i.e. music/noise source) for adults who desire to listen to such a background in the quiet.
The battery
Use a type 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 weak battery in the hearing aids while storing them. It
could leak and ruin your hearing aid.
Dispose of used batteries as indicated on the packaging and take note of
the expiry date.
Low battery indication
When the battery is weak, a sound signal will play. If the battery drains suddenly there may however be no warning. We recommend carrying a spare
battery with you wherever you go.
Changing the battery
To change the battery, do as follows:
Take the adhesive tab off the new battery and make
sure there is no sticky substance left on it. Let it
"breathe" for 60 seconds.
10
1. Use the nail grip to gently swing the battery door
open and remove the old battery.
2. 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.
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
Program 3
Message/three short beeps
Program 4
Message/one short and one long beep
11
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 selected models)
Your hearing care professional can turn on a feature in your hearing aid that
warns you whenever it loses contact with the hearing aid in the opposite
ear. You will hear a spoken message in your ear.
How to tell right from left
The hearing aid for your right ear has a red mark. The hearing aid for your
left ear has a blue mark.
Turning the hearing aid on and off
To turn the hearing aid on, close the battery door. The
hearing aid will play a sound signal to indicate that it is on,
unless your hearing care professional has deactivated this
function.
12
To turn off the hearing aid, push the battery door 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.
Putting on and removing your hearing aid
Putting on the hearing aid
1. Insert the ear-set in the ear while holding the lower
2
part of the tube/earwire. Pulling the outer ear upwards
and backwards at the same time can be helpful.
2. Then place the hearing aid behind the ear. The hearing
aid should rest comfortably on the ear, close to your
1
head.
Your hearing aid can be fitted using different types of ear-sets. See the separate ear-set manual for more information about your ear-set.
Removing the hearing aid
13
Start by removing the hearing aid from behind the
ear.
Then take the ear-set carefully out of the ear canal
while you hold the lower part of the tube/earwire.
Sound adjustment
Your hearing aid adjusts the 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.
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 canceled when you turn off your
hearing aid or if you change program.
14
Programs
PROGRAM
USE
Master
Standard
Music
Use this program if you want to listen to music
TV
This program is ideal when you want to listen to the TV
Comfort
This program reduces background noise
Reverse focus
Use this program if you want to focus on sounds from
behind you
Phone
Use this program when listening to phone conversations
Zen
Plays tones and noise for a relaxing sound background
Compound programs
The Master program in one hearing aid and Zen, Reverse focus, T, MT 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
15
If you have certain types of 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. It makes musical tones (and sometimes a rushing noise) in the
background using the latest Fractal technology. These sounds are shaped
according to your hearing loss so you can listen to them at any time and at
any place with a simple push of the program button.The Zen program may
be used alone (without amplification) in quiet when you are not required to
hear surrounding sounds. Or, it may be used with amplification so that both
the surrounding sounds and the generated sounds (fractal tones and noise)
are heard together.
16
CAUTION
Use of the different Zen programs may interfere with hearing surrounding
sounds including speech. The programs should not be used when hearing such
sounds is important. Switch the hearing aid to a non-Zen program in those situations.
The duration of the Zen play time can be set by your hearing healthcare professional according to your needs.
Benefits
The Zen program may provide a relaxing listening background for some
people. When the Zen program is used in a tinnitus management program,
its wearer may experience some relief from tinnitus.
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.
17
Directions for use
The Zen program can be activated with a simple push of the program button on the hearing aid (or on the remote control). Depending on how your
hearing care professional has set up the program, you can access the Zen
program by a "short-press" of the program button or a "long-press" of the
program button.
● "Short-press" option - the program button is pressed for less than a second. At most two listening programs can be programmed for Zen.
● "Long-press" option - the program button is pressed and held for more
than 1 second. Up to three Zen styles are available. A "short-press" of
the program button in the long-press mode will allow you to cycle
through the available Zen styles. You can exit the "long-press" mode by
pressing and holding the program button for more than one second.
Because of the unique ways in which Zen is programmed in your hearing
aid, please follow the recommendations of your hearing care professionals
as to how to use the program, when to use the program and/ or how long to
use the program.
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.
18
Prior to any tinnitus management program, it is advisable that you seek
medical attention to exhaust any medical or surgical treatment options.
Use your hearing aid and the Zen program according to the directions and
schedule recommended by your hearing care professionals.
Contraindications
The following symptoms are contraindicated for the use of hearing aids. Including the Zen program
● Congenital or traumatic deformity of the ear
● Active drainage from the ear within 90 days
● History of rapid progressive hearing loss within previous 90 days
● Acute or chronic dizziness
● Sudden unilateral hearing loss in previous 90 days
Warnings
Use of the Zen program may interfere with hearing everyday sounds including speech. It should not be used when hearing such sounds is important.
Switch the hearing aid to a non-Zen program in those situations.
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
19
● 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. Cloth
2. Brush
3. Long wax-removing tool
4. Short wax-removing tool
5. Battery magnet
1.
2. 3. 4. 5.
Cleaning
Cleaning your hearing aid every day will make it more efficient and more
comfortable to wear.
Wipe the hearing aid with a soft cloth (for example
the cloth you received from your hearing care professional).
If the microphone openings are blocked, contact your
hearing care professional.
Dry your hearing aid quickly if it gets wet, or if you perspire heavily. Some
people use a special dehumidifier like Widex PerfectDry Lux to help keep
their hearing aids dry and clean. Ask your hearing care professional if this is
right for you.
21
NOTE
It is recommended to remove the batteries from the hearing aids before placing
the hearing aids in a dehumidifier.
When not in use leave the battery compartment open to ventilate the hearing aid. For information on how to clean your ear-set, see the ear-set manual.
Do not use any kind of liquid or disinfectant to clean your hearing aid.
Clean and inspect your hearing aid every day after use to check that it is
not broken. If the hearing aid breaks while you are wearing it, leaving
small fragments in your ear canal, contact your doctor. Never try to take
out the fragments yourself.
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 2
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 for helping hearing aid users hear speech in difficult
Mic
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- It is not turned on
pletely silent
The battery does not
work
The hearing aid volume Your ear is blocked by
is not powerful enough earwax
Make sure the battery
drawer is completely
closed
Insert a new battery
Contact your doctor
Your hearing may have Contact your hearing
changed
care professional/doctor
The hearing aid whistles Your ear is blocked by
continuously
earwax
Contact your doctor
Your two hearing aids The connection between Turn them off and on
are not working in syn- the hearing aids is lost again
chrony
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” a. The battery in one of
speech (on and off)
the hearing aids has exfrom the hearing aids or pired
no speech (muted) from b. Strong electromagthe opposite hearing netic interference in the
aid.
vicinity
a. Replace battery in one
or both hearing aids
b. Move away from
known source of EM interference
NOTE
This information covers only the hearing aid. See the "Ear-sets for Widex hearing aids" user manual for information specific to your ear-set. If the problems
persist, contact your hearing care professional for assistance.
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- Inductive an- Inductive an- Embedded
tenna
tenna
tenna
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
-54 dBμA/m -13 dBμA/m -26 dBμA/m NA
Field
Strength (at
10 m distance)
Output power 29 pW
(EIRP**)
21 nW
1.2 nW
26
+4dB re. 1mW
Hearing aids RC-DEX
TM-DEX
Range
< 1 m remote < 1 m remote
unit to hear- unit to hearing aid
ing aid
< 30 cm between hearing
aids or Hearing aid to TMDEX
< 30 cm be- < 10 m between hearing tween PC and aid and TM- NOAHlink
DEX
Center frequency
10.6 MHz
10.6 MHz
Channel
Single channel Single channel Single channel 5 logical chanradio
radio
radio
nels
Bandwidth
660 kHz
(-15 dB)
660kHz
(-15 dB)
660kHz
(-15 dB)
Data-rate
212 kbit/second (raw
channel capacity)
212 kbit/second (raw
channel capacity)
212 kbit/sec- 2.1 Mbps
ond (raw
channel capacity)
Data flow
Simplex or
Simplex capa- Simplex or
Time division
semi-duplex bility
semi-duplex duplex (TDD)
capability
capability
10.6 MHz
27
Bluetooth* NOAHlink
2.4 GHz
1 MHz
Hearing aids RC-DEX
Protocol
TM-DEX
Bluetooth* NOAHlink
Random Ac- Random Ac- Random Ac- Packet-based
cess – no colli- cess – no colli- cess – no colli- protocol, time
sion avoid- sion avoid- sion avoid- divided; seance
ance
ance
cure 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 frequency 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 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.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not
applicable *)
Voltage fluctuations/
flicker emissions IEC
61000-3-3
Not
applicable *)
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.
*) 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
Compliance level Electromagnetic
Test level
environment –
guidance
Immunity Test
IEC 60601
Test level
Electrostatic dis- ± 6 kV contact
charge (ESD)
± 8 kV air
IEC
61000-4-2
Electrical fast
transients/burst
IEC
61000-4-4
Compliance level Electromagnetic
environment –
guidance
± 6 kV contact
± 8 kV air
± 2 kV for power Not
line supplies
applicable *)
± 1 kV for input/
output lines
Not
applicable *)
33
Floors should be
wood, concrete or
ceramic tile. If
floors are covered
with synthetic
material, the relative humidity
should be at least
30%.
Not
applicable *)
Immunity Test
IEC 60601
Test level
Compliance level Electromagnetic
environment –
guidance
Surge
IEC
61000-4-5
± 1 kV line(s) to
line(s)
Not
applicable *)
± 2 kV line(s) to
earth
Not
applicable *)
Voltage dips,
short interruptions and voltage
variations on
power supply input lines
IEC
61000-4-11
<5 % UT
Not
(>95 % dip
applicable *)
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
34
Not
applicable *)
Not
applicable *)
Immunity Test
IEC 60601
Test level
Power frequency 3 A/m
(50/60 Hz) magnetic field
IEC
61000-4-8
Compliance level Electromagnetic
environment –
guidance
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
DREAM™ series
hearing aid, including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the
transmitter.
36
Immunity Test
Conducted RF
IEC
61000-4-6
Radiated RF
IEC
61000-4-3
Immunity Test
IEC 60601
Test level
3 Vrms
Compliance level Electromagnetic
environment –
guidance
3 Vrms
Recommended
separation distance
d = 1.2 ÖP
150 kHz to 80
MHz
3 V/m
3 V/m
80 MHz to 2.5
GHz
IEC 60601
Test level
d = 1.2 ÖP
80 MHz to 800
MHz
d = 2.3 ÖP
800 MHz to 2.5
GHz
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 Separation distance according to frequency of transmitoutput power of ter (m)
transmitter
(W)
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 Separation distance according to frequency of transmitoutput power of ter (m)
transmitter
(W)
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, subpart RF emissions
C
USA Federal Communications Commission
(FCC) requirements for
intentional radiators.
EN 300 330-2
V1.5.1
RF emissions incl. Spuri- EMC and radio spectrum
ous emission
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 6011813:2011
Immunity
International Product
RF Near Field immunity std. for hearing aids to
test
ensure adequate immunity to radio interference from cell telephones.
ANSI C63.19-2007
Immunity
American National
RF Near Field immunity Standard Methods of
test
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 selecting and fitting a hearing aid whose maximum sound pressure level exceeds 132 decibels because there may be risk of impairing the remaining
hearing of the hearing aid user.
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 2014/53/EU
Hereby, Widex A/S declares that this D-m CB is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU.
The D-m CB contains a radio transmitter operating at 10.6 MHz, -54dBA/m
@10 m.
A copy of the Declaration of Conformity according to 2014/53/EU can be
found at:
http://global.widex.com/doc
N26346
Information regarding disposal
Do not dispose of hearing aids, hearing aid accessories and batteries with
ordinary household waste.
Hearing aids, batteries and hearing aid accessories should be disposed of at
sites intended for waste electrical and electronic equipment, or given to
your hearing care professional for safe disposal.
47
FCC and IC statements
FCC ID: TTY-DMCB
IC: 5676B-DMCB
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.
48
— 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.
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.
49
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.
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.
Catalogue number
The product’s catalogue (item) number.
Consult instructions for use
The user instructions contain important cautionary information (warnings/precautions) and must be read before using the product.
Warning
Text marked with a warning symbol must be read before using the
product.
WEEE mark
“Not for general waste”. When a product is to be discarded, it must be
sent to a designated collection point for recycling and recovering to
prevent the risk of harm to the environment or human health as a result of the presence of hazardous substances.
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
markets.
52
53
54
55
WIDEX A/S
Nymoellevej 6, DK-3540 Lynge, Denmark
http://global.widex.com
Manual no.:
9 514 0220 041 #07
CIB number:
CIB288
9 514 0220 041 #07
Issue: 2019-03
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