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Octiv R+
Instructions and guidance
United Kingdom
Sivantos Limited
Platinum House
Sussex Manor Business Park
Gatwick Road, Crawley
West Sussex RH10 9NH
Email: [email protected]
With the CE marking, Sivantos confi rms that this
hearing instrument fulfi ls all relevant European
guidelines, in particular directive 93/42 EEC of the
European Council applying to medical products.
For the products with e2e wireless 2.0 Sivantos
additionally confi rms compliance with the European
Directive 99/5/EC (R&TTE) concerning radio and
telecommunications terminal equipment.
Our quality management system, certifi ed by an
independent authority, assures consistently high
product quality and reliability to the customer.
2011/65/EU RoHs concerning the restriction of
hazardous substances
Legal Manufacturer
Sivantos GmbH
Henri-Dunant-Strasse 100
91058 Erlangen
Germany
Phone +49 9131 308 0
www.bestsound-technology.co.uk
0123
Storage
Transport
Temperature
10 to 40 °C
-20 to 60 °C
Relative
humidity
10 to 80 %
5 to 90 %
Air pressure
700 to
1050 hPa
200 to
1200 hPa
Intended use
Hearing instruments are intended
to improve the hearing of hearing
impaired persons. Diagnosis and
prescription of a hearing instrument
must be performed by hearing health
specialists, e.g. acousticians,
audiologists or ENT doctors.
Use the hearing instruments
and accessories only as
described in this user guide.
Transport and storage
conditions
During extended periods of transport
and storage, please observe the
following conditions:
In case of instrument failure
Is the instrument switched on?
Is the battery inserted correctly?
Is the battery run down?
Is the battery compartment
closed?
Is the sound opening in the ear
mould clogged with wax?
For other parts, such as batteries,
other conditions may apply.
NOTICE
To avoid environmental
pollution, do not throw
batteries into household
waste.
Recycle or dispose of
batteries according to
national regulations or
return them to your
NHS Provider.
Conformance information
With the CE marking Sivantos
confi rms compliance with the
European Directive 93/42/EEC
concerning medical devices.
For the products with e2e wireless
2.0 Sivantos additionally confi rms
compliance with the European
Directive 99/5/EC (R&TTE) concerning
radio and telecommunications
terminal equipment.
0123
Technical information
FCC ID: SGI-WL002BTE
IC: 267AB-WL002
Operating frequencies: Fc=3.28 MHz
Disposal information
Within the European Union, the
marked equipment is covered by
“Directive 2002/96/EC of the
European Parliament and of
the Council of 27
January 2003 on waste
electrical and electronic
equipment.” Amended by
“Directive 2003/108/EC” (WEEE).
NOTICE
Recycle hearing
instruments, accessories
and packaging according
to national regulations.
Important information
Personal safety
WARNING
Risk of impairing the residual hearing of the user.
Use only hearing instruments that have been fi tted especially for
your needs.
WARNING
Risk of injury!
Do not use obviously damaged devices and return them to point of sale.
WARNING
Risk of explosion!
Do not use your hearing instruments in explosive atmospheres
(e. g. in mining areas).
WARNING
Risk of affecting electronic equipment!
In areas where the use of electronics or wireless devices are
restricted, verify if your device has to be turned off.
WARNING
Risk of interference with active and non-active implants! If you wear an
active or a non-active implant, e.g. a brain implant:
Prior to use, have the electromagnetic compatibility verifi ed.
Consult the physician that implanted the device before using your
hearing instruments.
Keep a safe distance of about 1.6 inches (4 cm) between the implant
and hearing instruments.
WARNING
Choking hazard!
Your hearing instruments contain small parts which can be swallowed.
Keep hearing instruments, batteries and accessories out of reach
of children and mentally disabled persons.
If parts have been swallowed consult a physician or hospital
immediately.
CAUTION
Risk of injury!
Always wear the tube with an ear piece.
Make sure that the ear piece is completely attached.
CAUTION
Risk of injury!
Insert the ear piece carefully and not too deeply into the ear.
CAUTION
Risk of injury!
In very rare cases the ear piece could remain in your ear when
removing the hearing instrument. If this happens, have the ear
piece removed by a medical professional.
Important safety information
Product safety
NOTICE
Leaking batteries damage the hearing instruments.
Turn the hearing instruments off when not in use to preserve the battery.
Remove batteries when the instruments are not in use for a
prolonged period of time.
NOTICE
Protect your hearing instruments from extreme heat. Do not expose
them to direct sunlight.
NOTICE
Do not dry your hearing instruments in the microwave oven.
NOTICE
Different types of strong radiation, e. g. during X-ray or MRI head
examinations, may damage hearing instruments.
Do not wear the hearing instruments during these or similar procedures.
Weaker radiation, e. g. from radio equipment or airport security,
does not damage the hearing instruments.
NOTICE
Protect your hearing instruments from high humidity. Do not wear
them in the shower or when you apply make-up, perfume,
aftershave, hairspray or suntan lotion.
Only for two instruments or the use of a remote control:
In some countries restrictions for the usage of wireless equipment exist.
Refer to local authorities for further information.
NOTICE
Your hearing instruments are designed to comply with international
standards on electromagnetic compatibility but interference with
nearby electronic devices could occur. In this case, move away from
the source of interference.
Tinnitus noiser
Your hearing instrument may be equipped with a tinnitus noiser. The use of
the tinnitus noiser should be only on the advice and in consultation with
your NHS Provider.
WARNING
Risk of further impairment to the user’s hearing health.
There are some potential concerns associated with the use of any sound
generating tinnitus therapy device. Discontinue use and seek medical
evaluation if any of the following conditions occur:
chronic skin irritation on, near, or around the site of device placement.
unusual side effects (e.g. dizziness, nausea, headaches, heart
palpitations).
perceived decrease in auditory function (e.g. decreased loudness,
speech not as clear).
WARNING
Risk of further impairment to the user’s hearing health.
The volume of the tinnitus noiser can be set to a level which could lead to
permanent hearing damage when used for a prolonged period of time.
The tinnitus noiser should never be used at uncomfortable levels.
For NHS Providers:
The target population is primarily the adult population over 21 years of age.
The patient may have some control of the level or volume of the signal and the
patient should discuss this adjustment as well as his or her comfort level and
sound of the signal with their NHS Provider.
WARNING
Risk of further impairment to the user’s hearing health. The volume of the
tinnitus noiser can be set to a level which could lead to permanent hearing
damage when used for a prolonged period of time.
Should the tinnitus noiser be set to such a level in the hearing
instrument, advise the user of the maximum amount of time per
day he or she should use the tinnitus noiser.
For example, occupational safety guidelines restrict continuous noise
exposure of 80 dBA SPL to 8 hours per day.
The tinnitus noiser should never be used at uncomfortable levels.
WARNING
Risk of further impairment to the user’s hearing health. An NHS Provider
should advise a prospective tinnitus noiser user to consult promptly with a
licensed physician (preferably an ear specialist) before using the tinnitus
noiser if the NHS Provider 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:
Visible congenital or traumatic deformity of the ear.
History of active drainage from the ear within the previous 90 days.
History of sudden or rapidly progressive hearing loss within the
previous 90 days.
Acute or chronic dizziness.
Unilateral hearing loss of sudden or recent onset within the previous
90 days.
Audiometric air-bone gap equal to or greater than 15 dB at 500Hz,
1,000Hz and 2,000Hz.
Visible evidence of signifi cant cerumen accumulation or a foreign
body in the ear canal.
Pain or discomfort in the ear.
Manufactured by Sivantos GmbH under Trademark License of Siemens AG
Based on Document No. A91SAT-02148-99T02-7600 EN | D00115574
JN7482 | Pt No: 10824117 | Issue 3 | © 05.2015 Siemens AG
miniTek
™
wireless enhancement
Your Octiv R+ hearing instrument
can be used with the miniTek wireless
enhancement system. miniTek
provides a wireless connection from
your Octiv R+ hearing instruments to
your television, mobile phone, MP3
player and stereo. miniTek is also an
easy-to-use remote control for your
Octiv R+ hearing instruments for
convenient and discreet program and
volume adjustment. The miniTek
package comprises the miniTek
itself which controls the hearing
instruments, a Tek transmitter and all
cables necessary to link the miniTek
into a variety of devices such as TVs,
MP3 players, etc.
Octiv+ instruments are miniTek
and easyPocket compatible.
The easyPocket remote control is
available as an optional accessory
allowing for convenient and discreet
hearing instrument adjustment.
It is extremely ergonomic, has an
easy-to-read display and a modern,
stylish look.
Optional
NOTICE
miniTek and easyPocket
™
are additional products to your hearing
instrument which may be available to purchase. If you think it would
assist you in your day-to-day life talk to your NHS Provider about how you
can obtain a miniTek or easyPocket. Further information is available on
our website
www.bestsound-technology.co.uk
or
miniTek
easyPocket
