Siemens Octiv SP+ Instructions And Guidance

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Octiv SP+
Instructions and guidance
United Kingdom
Sivantos Limited Platinum House Sussex Manor Business Park Gatwick Road, Crawley West Sussex RH10 9NH Email: info-hearingaids.uk@sivantos.com
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
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miniTek™ wireless enhancement
Your Octiv SP+ hearing instrument can be used with the miniTek wireless enhancement system. miniTek provides a wireless connection from your Octiv SP+ hearing instruments to your television, mobile phone, MP3 player and stereo. miniTek is also an easy-to-use remote control for your Octiv SP+ 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 email info-hearingaids.uk@sivantos.com
miniTek
easyPocket
Your hearing instruments are so robust that they will function reliably for years. It is, however, important that you take care of your instruments and observe a few basic rules, which will soon become habit.
Cleaning
For hygiene reasons and to maintain functionality, clean your hearing instruments daily.
NOTICE
Do not put
the hearing instruments in water.
Clean your hearing instruments
with a soft, dry tissue.
Ask your NHS Provider for
recommended cleaning products, special care sets and further information on how to keep your hearing instruments in good condition.
For a more thorough professional
cleaning, take your instruments to your NHS Provider.
Storage
During longer periods of non-use,
store your hearing instruments with open battery compartment (and batteries removed) in a drying system in order to prevent the penetration of moisture.
Maintenance and care
Rocker switch
Function Left Right
Volume up/down
Tinnitus noiser level up/down
Sound balance
Push button and rocker switch
Function Left Right
Lock / Unlock the controls
Read more in section "Locking the controls".
Features
Power-on delay enables whistle-free insertion of hearing instruments. Read more in section "Turning on and off".
e2e wireless enables simultaneous control of both hearing instruments. Read more in section “Using two hearing instruments”.
With the controls you can, for example, adjust the volume or switch hearing programs. Your hearing instruments either have a push button and a rocker switch or a push button only. The NHS Provider has assigned your desired functions to the controls.
Ask your NHS Provider to mark your controls and their functions on the following pages.
Control Left Right
Push button
Rocker switch
You can also use a remote control.
Settings
Ask your NHS Provider to mark your individual settings on the following pages.
Battery size
Batteries
Non-rechargeable (size 675)
Controls
Push button
Function Left Right
Program change
Standby/ turn on
press briefl y,
press 2 seconds
Hearing programs
1
2
3
4
5
6
Read more in section "Changing
the hearing program".
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:
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.
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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?
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
Accessories
Remote control (miniTek or easyPocket)
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.
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.
WARNING
Choking hazard! Your hearing instruments contain small parts which can be swallowed.
Ensure adequate supervision if infants, small children or mentally
disabled persons need to wear hearing instruments.
Check the completeness of the hearing instruments regularly. Ensure that your child does not detach the hearing instrument from
the earmould.
Consult your NHS Provider if the housing is deformed. Keep the battery compartment locked. Verify the proper function of
the locking mechanism.
Keep batteries and accessories out of children's reach. If swallowed consult a physician or a hospital immediately.
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-02158-99T01-7600 EN | D00116348 JN7485 | Pt no: 10824116 | Issue 3 | © 05.2015 Siemens AG
Slide the cover in the direction of
the arrow into position. The shape of the cover depends on your type of hearing instrument.
Close the battery compartment.
Your Octiv™+ hearing instrument
CAUTION
Read this user guide thoroughly and completely and follow the safety information in this document to avoid damage or injury.
Getting to know your hearing instruments
It is recommended to familiarise yourself with your new hearing instruments. With the instruments in your hand try using the controls and note their location on the instrument. This will make it easier for you to feel and press the controls while wearing the hearing instruments.
If you have problems pressing the controls of your hearing instruments while wearing them, you can ask your NHS Provider about a remote control option.
Components and names
Earhook ૝Microphone openings ૞Push button ૟LED status indicatorRocker switch (standard) or fl at
cover for pediatric use (optional)
ૡBattery compartment
Explanation of symbols
Changing the batteries
Open the battery
compartment
૝ Remove coloured sticker
from new battery, place battery
in drawer with + symbol on battery + side up. (You should only remove the protective sticker if you actually use the battery)
૞ Close battery door
A magnet in the battery compartment ensures that the battery snaps noticeably into place.
Carefully close the battery
compartment. If you feel resistance, the battery is not inserted correctly.
Do not attempt to close the battery compartment by force. It can be damaged.
Child lock (optional)
Your hearing instruments can be modifi ed to provide a child-safe battery compartment, which can be locked (child lock). The child lock has to be activated by the NHS Provider.
With the child lock enabled, the battery compartment will automatically lock when closed. This prevents e.g. a child from removing and swallowing the battery.
To open the locked battery compartment, you need a tool. The tool is included with delivery of any child-lock battery compartment set.
Opening a locked battery compartment:
Use the tool to
push the white locking bar to the opposite side.
Hold it in place and at
the same time open the battery compartment.
Locking / Unlocking the battery compartment
To lock or unlock the battery compartment, a special tool is required. Your NHS Provider will lock or unlock the battery compartment for you. The following instructions are for your NHS Provider only.
The position of the locking bar in the battery compartment indicates whether the battery compartment is locked.
The upper image shows an unlocked battery compartment. To lock it, the NHS Provider has to remove the highlighted part.
The lower image shows a locked battery compartment. To unlock it, the NHS Provider has to install a child lock disabler.
For NHS Providers Only
Please visit www.bestsound-technology.co.uk for further instructions on how to do this.
When the battery compartment is locked, you need a tool to open it. Read more in section “Child lock”.
When the battery is low the sound becomes weaker or you will hear an alert signal. It depends on the battery type how long you have until you have to replace the battery.
Your NHS Provider can confi gure the LED to indicate the battery status. However, the hearing instrument must be turned on to indicate the status:
ঔ When the battery is full,
the LED shines constantly.
ঔ When the battery is low,
the LED fl ashes repeatedly, approximately every 5 seconds until the battery is empty.
ঔ When the battery is empty,
the LED goes out.
Always use the right size batteries.
Batteries
ঔ When wearing the hearing
instruments, an optional signal can indicate when an instrument is turned on or off.
ঔ Remove the batteries if the
hearing instruments are not used for several days.
ঔ Your NHS Provider can
confi gure the LED to shine when the instrument is turned on.
When the power-on delay is activated, the hearing instruments turn on after a delay of several seconds. During this time you can insert the hearing instruments without experiencing unpleasant whistling.
The “power-on delay” can be activated by your NHS Provider.
To insert the hearing instrument:
Hold the tube
at the bend that is closer to the ear piece.
Carefully push
the ear piece in the ear canal
.
Twist it slightly
until it sits well.
Lift the hearing instrument
and slide it over the top of your ear
.
ঔ Insert the right hearing
instrument with the right hand and the left hearing instrument with the left hand.
ঔ If you have problems
inserting the ear piece, use the other hand to gently pull your earlobe downwards. This opens the ear canal and eases insertion of the ear piece.
Removing
Lift the hearing instrument and
slide it over the top of your ear
.
Hold the ear
piece between your thumb and index fi nger. Carefully twist the ear piece forward while pulling it out
.
Clean and dry your hearing instruments after usage. Read more in section “Maintenance and care”.
Adjusting the volume
Your hearing instruments automatically adjust the volume to the listening situation.
If you prefer manual volume
adjustment, press the rocker switch briefl y or use a remote control.
Refer to section “Controls” for your
personal settings.
An optional signal can indicate the volume change.
Inserting
Your hearing instruments have been fi ne-tuned for your right and left ear. Coloured markers indicate the side:
red marker = right ear
blue marker = left ear
Turning on and off
You have several options to turn your hearing instruments on or off.
Via battery compartment:
Turning on: Close the battery
compartment. The default volume and hearing program are set.
Turning off: Open the battery
compartment.
Via push button:
Turning on or off: Press the
push button. Refer to section “Controls” for your personal settings.
After turning on, the previously
used volume and hearing program are set.
Via remote control:
Follow the instructions in the
remote control’s user guide.
After turning on, the previously
used volume and hearing program are set.
Daily use
Changing the hearing program
Your NHS Provider can confi gure the LED to indicate the program change: The LED light fl ashes once if you change to program 1, twice if you change to program 2, and so on.
To change the hearing program,
press the push button briefl y or use a remote control.
Refer to section “Controls” and
to section “Settings” for your personal settings and for a list of your hearing programs.
ঔ If you are wearing two
hearing instruments, you have to lock or unlock the controls on each hearing instrument separately.
ঔ Locking or unlocking can
optionally be indicated by an acoustic signal or by the LED light fl ashing briefl y.
ঔ When you turn your hearing
instruments off and on again, the key lock remains in the previously selected state.
On the phone
When you are on the phone, hold the telephone receiver slightly above your ear. The hearing instrument and telephone receiver have to be aligned. Turn the receiver slightly so that the ear is not completely covered.
Telephone program
You may prefer a certain volume when using the phone. Ask your NHS Provider to confi gure a telephone program.
Switch to the telephone program
whenever you are on the phone.
Whether a telephone program
is confi gured for your hearing instrument is listed in section “Settings”.
Whether this function is confi gured for your hearing instruments is listed in section “Controls”.
Further adjustments (optional)
The controls of your hearing instruments can also be used to change, for example, the sound balance or the tinnitus noiser level. Sound balance allows you to adjust the bass and treble to your preferences.
Refer to section “Controls” for your personal settings.
Locking the controls (optional)
To prevent any accidental operation you can lock the controls. When the controls are locked, both push button and rocker switch are disabled.
To lock the controls, press the
top of the rocker switch and hold
it. Simultaneously press the push button on the same hearing instrument for 3 seconds.
To unlock the controls, press the
bottom of the rocker switch and
hold it. Simultaneously press the push button on the same hearing instrument for 3 seconds.
Your NHS Provider can confi gure your hearing instruments so that they switch automatically to the audio shoe program if the audio shoe has been attached. Read more in section “Audio input”.
Using two hearing instruments
When controlling two instruments you have the following options to, for example, change the hearing program:
You can control each hearing
instrument separately.
You can control both hearing
instruments simultaneously.
Your NHS Provider has to activate the “e2e wireless” function, enabling both hearing instruments to exchange information. You can then use either a remote control or the user controls on either of your instruments for the desired function e.g. volume change.
The control elements of both instruments can even be set differently – thus offering you the degree of control you really need.
With an audio shoe you can connect your hearing instrument to an FM system. An FM system gathers speech at the voice source (via a separate microphone) and transmits the sound directly to the hearing instrument. This can be useful for adults in diffi cult listening situations and for children in classrooms.
Nowadays, most FM systems allow for coupling with audio devices like a MP3 player.
Your NHS Provider can confi gure your hearing instruments so that they switch automatically to the audio shoe program if the audio shoe has been attached.
If you want to use an audio shoe, a special battery compartment is required.
Ask your NHS Provider to
exchange the battery compartment.
WARNING
Risk of electric shock!
Connect audio input only
to a device conforming to IEC 60065, the IEC-Norm for audio, video and other electronic devices.
NOTICE
Use an approved audio shoe only. Ask your NHS Provider for this accessory.
NOTICE
Hold the audio shoe tightly
when you remove the FM receiver.
Attaching the audio shoe
Open the battery compartment. Pull the cover out.
The shape of the cover depends on your type of hearing instrument.
Slide the audio shoe in.
Ensure that it clicks noticeably
in place.
clic
k
Close the battery compartment.
Removing the audio shoe
When the audio shoe is not attached, you can install a cover to prevent dirt and dust from entering the housing.
Open the battery compartment.
Drag the slider on the audio shoe
back and at the same time move the audio shoe downwards to remove it from the device.
Audio input
NOTICE
For instruments with wireless connectivity: When the telecoil program is active, the remote control may cause a pulsing noise.
Use the remote control
with a distance greater than 10 cm (4 inches).
Many telephones as well as public places like theatres offer the audio signal (music and speech) via an audio induction loop. With this system, your hearing instruments can directly receive the desired signal – without distracting noise in the environment.
You can usually recognise audio induction loop systems by certain signs.
Ask your NHS Provider to confi gure a telecoil program.
Switch to the telecoil program
whenever you are in a place with an audio induction loop.
Whether the telecoil program
is configured for your hearing instrument is listed in section “Settings”.
Telecoil program and remote control
Audio induction loops
Points out a situation that could lead to serious, moderate, or minor injuries
Indicates possible property damage
Advice and tips on how to handle your device better
Information and warnings for children with hearing instruments
Optional symbol for custom models with wireless functionality
012
3
CE compliance label, confi rms compliance with certain European Directives, refer to section “Conformance information”
Indicates the legal manufacturer of the device
Do not dispose of the device with general domestic waste. Read more in section “Disposal information”
Read and follow the instructions in the user guide
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