Bernafon F2ITE02 Air conduction Hearing Aids with wireless functionality User Manual

Download:
Mirror Download [FCC.gov]
Document ID	3821450
Application ID	xKHuoYsuRxp/xzmNEIEX4g==
Document Description	Users Manual
Short Term Confidential	Yes
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	119.28kB (1490986 bits)
Date Submitted	2018-04-19 00:00:00
Date Available	2018-04-30 00:00:00
Creation Date	2018-04-09 13:17:53
Producing Software	Adobe PDF Library 15.0
Document Lastmod	2018-04-09 13:18:01
Document Title	Users Manual
Document Creator	Adobe InDesign CC 13.1 (Macintosh)

Instructions for Use
IN-THE-EAR HEARING AIDS
HEARTOO 140 I
HEARTOO 120 I
Table of Contents
Model overview
Introduction to this booklet
Your hearing aid – What it is
Step-by-step instructions for using your
hearing aid
Caring for your hearing aid
15
Common problems and solutions
19
Accessories21
General warnings
22
Warning to hearing care professionals
28
Children with hearing loss
31
International warranty
32
Mobile phone
34
Technical information
36
USA and Canada
37
Information and explanation of symbols
40
Conditions of use
42
Technical data
43
Model overview
This booklet is valid for the following hearing aid
families:
■ HearToo 140 I, with wireless functionality
■ HearToo 120 I, with wireless functionality
Introduction to this booklet
This booklet shows you how to use and maintain
your new hearing aid. Please read the booklet
carefully including the warning sections.
This will help you to get the most out of your
new hearing aid.
Your hearing care professional has adjusted the
hearing aid to meet your needs. If you have
further questions, please contact your hearing
care professional.
Intended use
The hearing aids are intended to amplify and
transmit sound to the ear and thereby
compensate for impaired hearing. The hearing
aids are intended to be used by children
(> 36 months) and adults.
I M P O R TA N T N OT I C E 
The hearing aid amplification is uniquely
adjusted and optimized to your personal
hearing capabilities during the fitting
performed by your hearing care professional.
Your hearing aid – What it is
Sound outlet with
wax protection
Canal
Push button
Battery drawer
Microphone
opening
Vent
Microphone
opening
AR_ILLU_ITCPD_BW
Step-by-step instructions for using
your hearing aid
Inserting the battery
·· Your hearing aid uses a size 312 battery.
·· Gently swing the battery drawer fully open,
but do not force it. (A)
·· Remove the sticker from the new battery. (B)
·· Place the battery into the empty compartment.
·· The + sign on the battery should face up. (C)
I M P O R TA N T N OT I C E 
Do not use the battery door as a handle to
insert or remove your hearing aid. It is not
designed for this purpose.
✼
For maximum power, allow the battery to be
aired for 30 seconds before placing it into the
empty compartment.
Turning the hearing aid ON
The battery drawer is used to switch the hearing
aid on. To preserve the battery, make sure your
hearing aid is switched off when you are not
wearing it.
Turn ON
Close the battery drawer
with the battery in place.
✼
Never use excessive force to open or close the
battery drawer.
Identify left and right hearing aid
It is important to distinguish between the left
and the right hearing aid as they might be
programmed differently.
You can find left/right color indicators on your
hearing aid.
·· A RED shell, text or indicator (dot) marks the
RIGHT hearing aid.
·· A BLUE shell, text or indicator (dot) marks the
LEFT hearing aid.
Put on the hearing aid
·· When inserting the right hearing aid, hold it
with the right hand. When inserting the left
hearing aid, hold it with the left hand.
·· Hold your hearing aid between your thumb and
index finger with the microphone on top. If
your hearing aid has a pull-out string, this must
be on the bottom. (A)
·· Place the canal part of your hearing aid in your
ear canal (B)
·· Gently pull your earlobe down with the other
hand while pushing the hearing aid in until it
feels secure and comfortable
✼
It takes patience and practice to insert your
hearing aid correctly. If you have difficulty,
please contact your hearing care professional
for further instructions.
10
Changing the volume
The push button allows you to adjust the volume.
You will hear a click when you turn the volume
up or down.
Two HearToo I hearing aids
Left hearing aid
Short press
(less than 1 sec.)
volume down
Right hearing aid
volume up
One HearToo I hearing aid
Short press
(less than 1 sec.)
volume down
Long press
(about 1 – 2 sec.)
volume up
The hearing aid will click to confirm that the
volume has been changed and then will beep
when you reach the programmed maximum or
minimum. You may hear a beep, when you return
to the preset loudness level in your hearing aid.
✼
Your hearing aid automatically returns to a
preset loudness level when it starts, or when
the battery is low. If you find that the volume is
not adequate, your hearing care professional
may need to adjust your hearing aid settings.
11
Muting your hearing aid
Use the mute function if you need to silence the
hearing aid while wearing it.
A long press (about 2 seconds) on the push
button will cause your hearing aid to mute.
To un-mute the hearing aid, give a push to the
push button.
✼
If you wear one hearing aid (monaural fitting),
it is not possible to mute it.
I M P O R TA N T N OT I C E 
Do not use the mute function as an off switch,
as the hearing aid still draws current from the
battery in this mode.
12
Removing your hearing aid
·· Use your thumb to push up against the bottom
(back part) of your ear to loosen the hearing
aid
·· Grasp the hearing aid at its edge between your
thumb and forefinger. Gently remove it from
your ear.
·· If your hearing aid has a removal (pull-out)
string, pull it gently
Turning the hearing aid OFF
Place your fingernail underneath the front edge
of the battery drawer and lift to open.
The hearing aid is now OFF.
Open (OFF)
13
Changing the battery
When the battery is running out, the hearing aid
will beep at regular intervals. You should be
prepared to replace the battery. The time until
the hearing aid stops working depends on the
battery type and manufacturer. Mercury-free
batteries generally cause earlier warning beeps.
Replace ProWax filter
·· Remove the tool from the shell. The tool has
two pins, one empty for removal and one with
the new ProWax filter. (A)
·· Push the empty pin into the ProWax filter in the
hearing aid’s speaker and pull it out. (B)
·· Insert the new ProWax filter using the other pin.
Remove the tool and throw it out. (C)
New filter
I M P O R TA N T N OT I C E 
Always use the same type of wax filter as was
originally supplied with the hearing aid. If you
are in any doubt about the use or replacement
of wax filters, contact your hearing care
professional.
14
Caring for your hearing aid
Healthy ears produce a waxy substance that can
clog your hearing aid. Please follow these
cleaning instructions to prevent wax build-up
and ensure optimal performance of your hearing
aid.
For further information on the care of your
hearing aid, please contact your hearing care
professional.
General care instructions
Treat your hearing aid like any other delicate
electronic device (check the safety guidelines on
page 22) and make sure that the hearing aid
does not come in contact with moisture or water.
Always clean and dry your hands thoroughly
before handling the hearing aid.
15
Should your hearing aid come in contact with
water and stop working, please follow these
guidelines:
·· gently wipe off any water on the outside of the
hearing aid;
·· open the battery door and remove the battery;
·· gently wipe off any water in the battery dawer;
·· let the hearing aid dry with the battery drawer
open for approximately 30 minutes;
·· insert a new fresh battery and close the battery
drawer. Your hearing aid should work normally
again.
I M P O R TA N T N OT I C E 
Do not wear your hearing aid while showering
or participating in water activities. Do not
immerse your hearing aid in water or other
liquids.
16
Daily care instructions
·· Check your hearing aid for ear wax and wipe it
clean with a cloth or tissue
·· If necessary, use the cleaning tool to remove
wax from the canal and vent openings on your
hearing aid
·· Open the battery drawer fully to allow air to
circulate during the night
I M P O R TA N T N OT I C E 
Use a soft, dry cloth to clean the hearing aid. It
must never be washed or immersed in water or
other liquids.
17
Specific care instructions
Clean your hearing aid (including parts) on a
regular basis, as recommended by your
hearing care professional. Microorganisms from
an unclean hearing aid may cause skin irritations.
Cleaning the sound outlet
The sound outlet is an integral part of your
hearing aid and should be kept clean and free
from ear wax at all times.
Your hearing aid is built with a wax protection
system (ProWax). Please ask your hearing care
professional for the instructions on how to
exchange the wax protection filter on your
hearing aid.
18
Common problems and solutions
Hearing aid whistles or squeals
Check that the hearing aid is inserted correctly. If
this is the case and the hearing aid still whistles
or squeals, please contact your hearing care
professional.
No volume, level too soft or humming noise
Check if the volume level is too soft and adjust
by increasing the volume level with the control
on your hearing aid. If you have no volume at all,
check whether the hearing aid is in mute
position. If the problem still occurs, check that
the battery door is closed completely. Also check
if the battery is inserted correctly. If the problem
still remains, change the battery. If the problem
still persists, contact your hearing care
professional.
19
Whirring noise, fading, weak or motor-boating sounds
Open and close the battery drawer several times
or clean the battery contacts carefully with a dry
cotton swab. If the problem still occurs, change
the battery. If the problem still remains, contact
your hearing care professional.
Hearing aid switches from ON to OFF periodically
Your battery is running down. Please change the
battery.
Hearing aid beeps without any action from you
Your battery is running down. Please change the
battery.
Other problems with your hearing aid
If other problems occur with your hearing aid
which are not listed, contact your hearing care
professional.
20
Accessories
For HearToo 140 hearing aids, the following
accessory is available:
■ Remote control. For more details, please refer
to the Instructions for Use for the remote
control.
For further information on accessories, please
contact your hearing care professional.
Remote control
11
RC-N_ILLU_OperationHandHeld_BW
21
General warnings
You should familiarize yourself fully with the
following general warnings and the entire
contents of this booklet before using your
hearing aid to ensure personal safety and correct
use.
Contact your hearing care professional if you
experience unexpected operations or events with
your hearing aid.
Please note that a hearing aid will not restore
normal hearing and will not prevent or improve a
hearing impairment resulting from organic
conditions. Furthermore, note that in most cases,
infrequent use of a hearing aid does not permit a
user to attain full benefit from it.
22
General warnings
Usage of hearing aids
·· Hearing aids should be used only as directed
and adjusted by your hearing care professional.
Misuse can result in sudden and permanent
hearing loss.
·· Never allow others to wear your hearing aid as
incorrect usage could cause permanent
damage to their hearing.
Choking hazards & risk of swallowing batteries and other
small parts
·· Hearing aids, their parts, and batteries should
be kept out of reach of children and anyone
who might swallow these items or otherwise
cause injury to themselves.
·· Batteries have occasionally been mistaken for
pills. Therefore, check your medicine carefully
before swallowing any pills.
If a battery or hearing aid is swallowed, see a
doctor immediately.
23
General warnings
Battery use
·· Always use batteries recommended by your
hearing care professional. Batteries of low
quality may leak and cause bodily harm.
·· Never attempt to recharge your batteries and
never dispose of batteries by burning them.
There is a risk that the batteries will explode.
Dysfunction
·· Be aware of the possibility that your hearing aid
may stop working without notice. Keep this in
mind when you depend on warning sounds
(e.g., when you are in traffic). The hearing aids
may stop functioning, for instance if the
batteries have expired or if the sound outlet is
blocked by moisture or ear wax.
Active implants
·· Caution must be taken with active implants. In
general, follow the guidelines recommended by
manufacturers of implantable defibrillators and
pacemakers regarding use with mobile phones
and magnets.
·· If you have an active brain implant, please
contact the manufacturer of your implantable
device for information about the risk of
disturbance.
24
General warnings
X-ray, CT, MR, PET scanning, electrotherapy and surgery
·· Remove your hearing aid before X-ray,
CT/MR/PET scanning electrotherapy,
surgery etc. as your hearing aid may be
damaged when exposed to strong fields.
Heat and chemicals
·· The hearing aid must never be exposed to
extreme heat, for example, left inside a parked
car in the sun.
·· The hearing aid must not be dried in microwave
ovens or other ovens.
·· The chemicals in cosmetics, hairspray, perfume,
aftershave lotion, suntan lotion and insect
repellent can damage the hearing aid. Always
remove your hearing aid before applying such
products and allow time to dry before use.
25
General warnings
Possible side effects
·· Hearing aids may cause an accelerated
accumulation of ear wax.
·· The otherwise non-allergenic materials used in
hearing aids may in rare cases cause a skin
irritation or other side effects.
Please seek consultation with a physician if
these conditions occur.
Interference
·· The hearing aid has been thoroughly tested for
interference, according to the most stringent
international standards. However, interference
between the hearing aid and other devices
(e.g. some mobile telephones, citizens band
systems, shop alarm systems, and other
devices) may occur. If this occurs, increase the
distance between the hearing aid and the
interfering device.
26
General warnings
Connection to external equipment
·· The safety of the use of the hearing aid when
connected to external equipment (via auxiliary
input cable, via USB cable, or directly), is
determined by the external equipment. When
connected to external equipment plugged into
a wall outlet, this equipment must comply with
IEC-60065, IEC-60950 or equivalent safety
standards.
Safety information
·· Hearing aids should be adjusted by a hearing
care professional.
·· Never insert cleaning tools into the sound
outlet or microphone inlet. This could damage
the hearing aid.
·· Remove your hearing aid before sleeping.
·· Keep your hearing aid in the case for protection
when you are not wearing it.
·· Be aware of the possibility that the directional
microphone in your hearing aid may reduce the
volume of some warning sounds coming from
behind you.
27
Warning to hearing care
professionals
A hearing care professional 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 care professional determines through
inquiry, actual observation, or review of any
other available information concerning the
prospective user, that the prospective user has
any of the following conditions:
i.
Visible congenital or traumatic deformity of
the ear.
ii. History of active drainage from the ear within
the previous 90 days.
iii. History of sudden or rapidly progressive
hearing loss within the previous 90 days.
iv. Acute or chronic dizziness.
v. Unilateral hearing loss of sudden or recent
onset within the previous 90 days.
vi. Audiometric air-bone gap equal to or greater
than 15 decibels at 500 hertz (Hz), 1,000 Hz,
and 2,000 Hz.
vii. Visible evidence of significant cerumen
accumulation or a foreign body in the ear
canal.
viii. Pain or discomfort in the ear.
28
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. (This provision is
required only for those hearing aids with a
maximum sound pressure capability greater than
132 decibels [dB SPL].)
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 care professional, as
appropriate, for a hearing aid evaluation.
29
The audiologist or hearing care professional 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 hearing care professional 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 care professionals 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 this device
to sale by or on the order of a doctor, audiologist
or other hearing care practitioner licensed to
dispense hearing aids in your state-in accordance
with all applicable rules and regulations.
30
Children with hearing loss
In addition to seeing a physician for 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
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.
Contact the National Poison Center at
1-800-222-1222 or National Battery Ingestion
Hotline at 202-625-3333.
31
International warranty
Your hearing aid is covered by an international
limited warranty issued by the manufacturer for a
period of 12 months from the date of delivery.
This limited warranty covers manufacturing and
material defects in the hearing aid itself, but not
in accessories such as batteries, tubing,
speakers, earpieces and filters, etc. Problems
arising from improper/incorrect handling or care,
excessive use, accidents, repairs made by an
unauthorized party, exposure to corrosive
conditions, physical changes in your ear, damage
due to foreign objects entering the device or
incorrect adjustments are NOT covered by the
limited warranty and may void it.
The above warranty does not affect any legal
rights that you might have under applicable
national legislation governing sale of consumer
goods. Your hearing care professional may have
issued a warranty that goes beyond the clauses
of this limited warranty. Please consult him/her
for further information.
If you need service
Take your hearing aid to your hearing care
professional, who may be able to sort out minor
problems and adjustments immediately.
32
Date:
Model:
Warranty period:
Model L:
Model R:
Serial no.:
Serial no.:
Battery size:
Battery size:
Hearing care professional contact details:
✼
Do not attempt to repair your hearing aid
yourself.
33
Mobile phone
Some hearing aid users have reported a buzzing
sound in their hearing aid when they are using
mobile phones, indicating that the mobile phone
and hearing aid may not be compatible.
The ANSI C63.19 standard determines the
prediction of compatibility between a specific
hearing aid and a mobile phone by adding the
numerical value of the rating for the hearing aid
immunity to the numerical value of the rating for
the mobile phone emissions.
A sum of 4 would indicate that the combination
of wireless device and hearing aid is usable; a
combined rating that equals 5 would provide
normal use; a combined rating of 6 or greater
would indicate excellent performance.
Whereas all hearing aids have acoustic coupling,
only the larger hearing aids have the physical
space for telecoil (inductive) coupling. These two
types of coupling have different rating scales
(M1 – M4 for acoustic coupling and T1 – T4 for
telecoil coupling, respectively) and both ratings
are therefore relevant when predicting the
compatibility of a particular hearing aid.
For a hearing aid with both acoustic coupling
and telecoil coupling with a rating of M4/T2 and
with a telephone rating of M3/T3, the combined
rating is 7 (M4 + M3) for the acoustic coupling
and 5 (T2 + T3) for the telecoil coupling.
34
According to the guideline given above, both
types of coupling will thereby be acceptable, with
the acoustic coupling indicating excellent
performance and the telecoil coupling indicating
normal use. The equipment performance
measurements, categories and system
­classifications are based upon the best information
available, but it cannot be guaranteed that all users
will be satisfied.
The immunity of this hearing aid is at least M2/T2.
The equipment performance measurements,
categories and system classifications are based
upon the best information available but cannot
guarantee that all users will be satisfied.
I M P O R TA N T N OT I C E
The performance of individual hearing aids may
vary with individual mobile phones. Therefore,
please try this hearing aid with your mobile
phone or, if you are purchasing a new phone,
be sure to try it with your hearing aid prior to
purchase. For additional guidance, please ask
your mobile phone provider for the booklet
entitled “Hearing Aid Compatibility with Digital
Wireless Cell Phones”.
35
Technical information
The hearing aid contains a radio transmitter
using short range magnetic induction technology
working at 3.84 MHz. The magnetic field strength
of the transmitter is very weak and is always
below –40 dBμA/m at 10 meter distance.
The emission power from the radio system is well
below international emission limits for human
exposure. For comparison, the radiation of the
hearing aid is lower than unintended
electromagnetic radiation from for example
halogen lamps, computer monitors, dishwashers,
etc.
The hearing aid complies with international
standards concerning radio transmitters,
electromagnetic compatibility and human
exposure.
Due to the limited space available on the hearing
aid, all relevant approval markings are found in
this document.
36
USA and Canada
The hearing aid contains a radio module with the
following certification ID numbers:
FCC ID: U6XF2ITE02
IC: 7031A-F2ITE02
The device complies with Part 15 of the FCC
rules and RSS-210 of Industry Canada.
Operation is subject to the following two
conditions:
1. this device may not cause harmful
interference;
2. this device must accept any interference
received, including interference that may
cause undesired operation.
Changes or modifications not expressly
approved by the party responsible for
compliance could void the user’s authority to
operate the equipment.
37
This Class B digital apparatus complies with
Canadian ICES-003.
Note: This equipment has been tested and found
to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable
protection against harmful interference in a
residential installation.
This equipment generates, uses and can radiate
radio frequency energy and, if not installed and
used in accordance with the instructions, may
cause harmful interference to radio
communications.
However, there is no guarantee that interference
will not occur in a particular installation. If this
equipment does cause harmful interference to
radio or television reception, which can be
determined by turning the equipment off and on,
the user is encouraged to try to correct the
interference by one or more of the following
measures:
·· reorient or relocate the receiving antenna;
·· increase the separation between the equipment
and receiver;
·· connect the equipment into an outlet on a
circuit different from that to which the receiver
is connected;
·· consult the manufacturer or an experienced
radio/TV technician for help.
38
The manufacturer declares that this hearing aid is
in compliance with the essential requirements
and other relevant provisions of Directive
2014/53/EU.
Declaration of Conformity is available at the
manufacturer.
Manufacturer:
Bernafon AG
Morgenstrasse 131
3018 Bern
Switzerland
www.bernafon.com
0543 0682
Waste from electronic
equipment must be
handled according to local
regulations.
E2105
39
Information and explanation
of symbols
The CE marking indicates compliance to
all applicable European Directives. The
4-digit numbers after the CE marking
correspond to the identification number
of notified bodies.
This symbol indicates that the products
described in these instructions for use
adhere to the requirements for an applied
part of Type B of EN 60601-1. The surface
of the hearing aid is specified as applied
part of Type B.
The crossed-out wheeled bin indicates the
European Directive 2011/65/EU on waste
of electronic equipment applies. Please
recycle your hearing aid and batteries
according to your local regulations or
return them to your hearing care
professional for disposal.
40
This symbol indicates to follow the
instructions for use in this booklet
E2105
EMC and Radio communications
compliance label Australia and New
Zealand
Manufacturer
Keep dry
REF Catalogue number
SN Serial number
41
Conditions of use
Operating
conditions
Storage and
transportation
conditions
42
Temperature:
+34 °F to +104 °F
Relative humidity:
5 % to 93 %, non-condensing
Temperature and humidity
should not exceed the
following limits for
extended periods during
transportation and storage:
Temperature:
–13°F to +140 °F
Relative humidity:
5 % to 93 %, non-condensing
Technical Data
IN-THE-EAR HEARING AIDS
HEARTOO 140 I
HEARTOO 120 I
43
HearToo I
2CC COUPLER
HearToo 140 HearToo 120
OSPL 90, HFA (dB SPL)
113
43
43
Reference Test Gain (dB)
35
35
Frequency Range (Hz)
100–9700
100–7500
Distortion 500/800/1600 Hz (%)
<2/<2/<2
<2/<2/<2
19
20
Equivalent Input Noise, (dB A)
Operating Current (mA)
44
112
Full-on Gain, HFA (dB)
1.2
1.2
Attack Time (ms)
± 1.1
± 1.1
Release Time (ms)
± 10
± 10
2CC COUPLER
Output / dB SPL
Output OSPL 90
120
110
100
90
80
70
100
Frequency (Hz)
1k
10k
140
Output / dB SPL
130
Frequency Response
120
110
110
100
100
90
90
80
70
60
100
Frequency (Hz)
1k
10k
HearToo I 140
HearToo I 120
Additional Information
Technical data measured with expansion, corresponding to
the test box measurement settings.
“2cc” refers to a coupler according to IEC 60318-5:2006.
Applied versions: ANSI S3.22-2014, IEC 60118-0:2015.
Full-on gain is measured with the gain control of the
hearing aid set to its full-on position minus 20 dB and with
an input SPL of 70 dB. This is to obtain a gain response
equal to the full-on gain response from e.g.
ANSI S3.22-2014, but without influence of feedback.
45
185778/US
<>
9.0 mm
<>
19 mm
Placeholder
for FSC logo
8,15 mm
15 mm
0000185778000001
2018-02-28/185778/US/subject to change
Manufacturer:
Bernafon AG
Morgenstrasse 131
3018 Bern
Switzerland
www.bernafon.com

---

Source Exif Data:

EXIF Metadata provided by EXIF.tools