Bone Anchored Hearing System Instructions for Use Sound processor
The Instructions for Use The Ponto 5 Mini sound processor is intended for improvement of hearing for patients with conductive or mixed hearing losses, whether unilaterally or bilaterally fitted, or for those with single sided deafness. It is designed so that it can be optimised for each individual person. This will help ensure you get the maximum benefit from your sound processor.
About: The Instructions for Use.......................................................................................3 In the box............................................................................................................6 Processor view.................................................................................................... 7 The Ponto bone anchored hearing system............................................................
Care and maintenance: Sound processor maintenance...........................................................................28 Skin hygiene.....................................................................................................29 Accessories: Accessories....................................................................................................... 31 Plug for programming socket.............................................................................
In the box • • • • • • • • • • 6 Ponto 5 Mini sound processor Ponto Case Batteries (size 312) Safety line Plug for programming socket, including left/right indication Ponto stickers Test rod Abutment covers, black and beige Tamper resistant battery drawer kit Tool for opening the tamper resistant battery drawer
Processor view Microphone inlets Battery drawer (with nail grip or tamper resistant) Coupling LED (light diode) Safety line attachment Warning: The sound processor contains small parts that may be a choking hazard for smallchildren. Batteries can also be harmful if swallowed. Always keep batteries out of reach of small children or people of diminished mental capacity. If a sound processor is accidentally swallowed, seek medical attention at the nearest emergency department.
The Ponto bone anchored hearing system Your Ponto 5 Mini is designed to help you gain improved hearing through direct bone conduction. The sound processor converts sound into vibrations that are transmitted via the abutment and implant through the skull bone to the inner ear. This method works independently of the function of the ear canal and middle ear.
Abutment Sound processor Implant 9
Turning the sound processor ON and OFF The battery drawer is also used to switch the sound processor on and off. To save battery life, make sure your sound processor is switched off when you are not wearing it. During longer storage, it is recommended that you remove the battery from the sound processor. Turn ON Close the battery drawer with the battery in place. Turn OFF Open the battery drawer fully. Optional LED Two long green flashes indicate that the hearing aid is turned on.
When to replace the battery When it is time to replace the battery, you will hear three beeps repeated in moderate intervals until the battery runs out. The battery lifetime depends on the listening environment. Three tones* = The battery is running low Four descending tones = The battery has run out Note: To make sure the sound processor is always working, bring spare batteries with you or replace the battery before you leave home.
How to replace the battery Ponto 5 Mini uses a size 312 zinc-air battery. Use high-quality zinc-air batteries for optimal performance. 1. Open 2. Uncover Remove the sticky label from the + side of the new battery. Fully open the battery drawer. Remove the battery. Note: Wait 2 minutes so that the battery can draw air, to ensure optimal functioning. Warning: The sound processor contains small parts that may be a choking hazard for small children. Batteries can also be harmful if swallowed.
3. Insert 4. Close MultiTool Insert the new battery into the battery drawer. Make sure the + side is facing down. Note: If the battery is inserted incorrectly, the battery drawer cannot be closed. Using force risk damaging the battery compartment. Close the battery drawer. The sound processor will play a jingle. Note: A MultiTool can be used for battery change. Use the magnetic end to remove and insert batteries. The MultiTool can be provided by your hearing care professional.
Connection To safely and comfortably connect the sound processor, tilt it slightly and carefully push it onto the abutment. It is important to keep hair out of the way when the sound processor is connected to the abutment.
Disconnection The sound processor is safely and comfortably disconnected by carefully tilting it away from the abutment.
Correct position To get optimal performance from the directional microphone system, the sound processor should be positioned vertically with the microphone inlets positioned horizontally. Note: Please note, it is important that the sound processor does not touch anything, e.g. the ear, skin or a hat. This can cause feedback (a whistling sound).
Microphones Correct position Incorrect position 17
Optional features and accessories The features and accessories described in the following pages are optional. Please contact your hearing care professional to find out how your sound processor is programmed. If you experience difficult listening situations, a special programme may be helpful. These are programmed by your hearing care professional.
Tamper resistant battery drawer Your hearing care professional can attach a tamper resistant battery drawer. To unlock the tamper resistant drawer insert the tip of the tool into the hole on the left side of the battery drawer. Lever the tool against the sound processor and press downwards to open the battery drawer. Important: The tamper resistant battery drawer must always be used by children under the age of 36 months due to risk of swallowing and choking.
Volume control The volume can be controlled from a Bluetooth-connected device, e.g. Smartphone, connectivity products etc. When the volume is changed, it will be indicated by beeps. When the maximum or minimum volume has been reached three beeps are heard. When passing the default start-up volume, two tones are heard.
Change programme Your sound processor can save up to four different programmes configured by your hearing care professional. Depending on the programme you choose (1, 2, 3 or 4), you hear one to four tones. Programme changes are made on the connected Smartphone or connectivity product. For information regarding tones, see the Sound and LED light indicators section.
Mute Use the mute function if you need to silence the sound processor in shorter periods of time. Your sound processor can be muted by using one of the following optional devices: Oticon ON App ConnectClip Remote Control 3.0 How to unmute your sound processor The sound processor can be unmuted using one of the optional devices. Note: Do not use the mute function as an off switch, as the sound processor still draws current from the battery in this mode.
Use the sound processor with iPhone and iPad Your sound processor is a Made for iPhone® device and allows for direct communication and control with iPhone, iPad® or iPod touch®. For assistance in using these products with your sound processor, please contact your hearing care professional or visit: www.oticonmedical.com/wireless-connectivity For information on compatibility, please visit: www.oticonmedical.
Pairing the sound processor with iPhone 1. Settings Bluetooth 2. Accessibility 3. Turn on On Hearing Devices Accessibility Open your iPhone and go to “Settings”. Make sure Bluetooth is on. Then choose “General”. 24 On the “Accessibility” screen, choose “Hearing Devices”. Open and close the battery drawer on the sound processor. The sound processor remains in pairing mode for 3 minutes.
4. Hearing devices 5. Your hearing device ✓ William’s Hearing Aids Bluetooth Pairing Request William’s Hearing Aids would like to pair with your iPhone Cancel Check if your iPhone has detected your sound processor. Pair Here you can see the options for your sound processor.
Oticon ON App Oticon ON App for iPhone, iPad, iPod touch and Android™ devices offers an intuitive and discreet way to control your sound processor. The App is available on the App Store® and on Google Play™. When installing Oticon ON App on iPad, search for iPhone apps in App Store. Please find more details on: www.oticonmedical.com Apple, the Apple logo, iPhone, iPad, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.
Wireless accessories Your sound processor offers wireless connection to a range of wireless accessories. ConnectClip When ConnectClip is paired with your mobile phone, you can use the sound processor as a handsfree headset. Remote Control 3.0 Remote Control offers the ability to change programme, adjust volume or mute your sound processor. EduMic Wireless remote microphone system that supports users with a hearing loss in a classroom setting. TV Adapter 3.
Sound processor maintenance Your sound processor is dust tight and protected against ingress of water, which means it is designed to be worn in daily life situations. However, the sound processor is not waterproof. If the sound processor accidentally gets wet, open the battery drawer and let the sound processor dry. The chemicals in cosmetics, hair spray, perfume, aftershave lotion, suntan lotion and insect repellent can damage the sound processor.
Skin hygiene Daily cleaning In order to reduce the risk of skin infections around the abutment, it is important to maintain a good daily cleaning routine. Before the skin has fully healed, antibacterial soap and non-alcohol baby wipes may be used to clean the area around the abutment. When healing has progressed, you should start using a cotton swab or a soft brush. Use the brush on a daily basis, together with soap and water, to gently clean the outside and inside of the abutment.
Cleaning every few days In addition to the daily cleaning routines, the skin should be cleaned more thoroughly to remove debris at least twice a week. During hair washing, debris becomes softer and is easier to remove. The cleaning brush should still be used with care. If you have persistent problems with soreness surrounding the abutment, contact your ENT clinic. Parents or caregivers are responsible for maintaining good hygiene around a child’s abutment.
Accessories Safety line The safety line is designed to help you avoid dropping your sound processor during physical activity or in other situations where the device could fall off. To avoid dropping your sound processor, attach the safety line to the sound processor and the clip to your clothing. We also recommend that you use the safety line at first when you are getting used to wearing the device.
Test rod The test rod allows you to listen to the sound processor without connecting it to an abutment. Connect your Ponto 5 Mini to the test rod and press it against your head to listen. When holding the rod, your hand should not touch the sound processor. This may cause a feedback/a whistling sound. Stickers The sticker allows you to change the appearance of your sound processor. The sticker is applied to the round element of the sound processor’s front. Be gentle when removing the sticker.
Plug for programming socket The sound processor comes with a black plug in the programming socket. The safety line can be threaded while using the plug and it does not need to be removed from the device. If removal is needed, the tool for opening the tamper resistant battery drawer can be used.
Left and right indication (when using two sound processors) The Ponto 5 Mini devices are non-side specific and will be programmed to the left or right side by your hearing care professional. To help distinguish between the devices, left and right indication plugs can be inserted in the programming socket. Your hearing care professional can apply these.
Service and repair If your Ponto 5 Mini sound processor does not function properly, please contact your clinic to get it checked.
Ponto 5 Mini is compatible with the following articles Description Article Abutments in Oticon Medical Ponto implant system All Genie Medical BAHS (Fitting software, version 2021.2 or later) Softbands from Oticon Medical Oticon Medical accessories SoundConnector Test band Head band ConnectClip TV Adapter 3.0 Oticon A/S accessories Remote Control 3.
Compatibility Guide Description Article Compatible products from Cochlear Bone Anchored Solutions AB (BAS) Baha® abutments (90305, 90410) Baha® implants with abutment (90434, 90480) Baha® BA300 Series abutments Incompatible products from Cochlear BAS Baha® BA210 Series abutments Baha® BA400 Series abutments 37
Common problems and their possible solutions Symptom No sound Possible causes Worn-out battery Sound processor is on stand-by (mute) Dirt in the coupling or sound inlet Intermittent or reduced sound Moisture Worn-out battery Whistling noise 38 Sound processor is touching something
Solutions Change battery pages 12 –13 Check the Oticon ON App if mute is enabled page 22 Clean the sound processor page 28 Open the battery drawer and let the sound processor dry in its case page 10 Change battery pages 12 –13 Check if the sound processor is correctly connected and is not touching e.g. skin or glasses pages 16–17 If none of the above solutions solve the problem, please contact your clinic for assistance.
Manufacturer’s warranty Oticon Medical sound processors are covered by a 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 sound processor itself, but not batteries.
Important information • It is important to follow the skin hygiene guidelines. Please contact your ENT clinic if you have questions or concerns. • Always keep your sound processor in its case when not in use to protect it from dust and dirt. If you are using a skin, please make sure you remove the skin before placing the sound processor in its case. • Whenever the sound processor is not in use, ensure it is switched off by opening the battery drawer.
• At the airport, inform the personnel that you are wearing implantable hearing devices. Recommendation whether or not to remove the sound processor(s) will be given at the security check point. • When travelling by plane, turn the instruments off during take off and landing to disable Bluetooth, unless Bluetooth is permitted by the flight personnel. • The power source in your sound processor has insufficient energy to cause fire under normal conditions of use.
Regulatory compliance statements This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence-exempt RSS(s) and complies with part 15 of the FCC Rules. 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 of the device.
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 distance between the equipment and the receiver. • Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.
The sound processor contains a radio transceiver using Bluetooth Low Energy (BLE) and a proprietary short-range radio technology, both working at 2.4 GHz. The 2.4 GHz radio transmitter is weak and is always below 4 dBm EIRP in total radiated power. Due to the limited size available on the device, relevant approval markings are found in this document. Additional information can be found in the “Product Information”.
Warnings • You should familiarise yourself fully with the following general warnings before using your sound processor for your personal safety and to ensure correct use. • Please note that a hearing device 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 device does not permit a user to attain full benefit from it.
Usage of sound processors • Sound processors should be used only as directed and adjusted by your hearing care professional. • Never allow others to wear your sound processor. It is fitted to you. Choking hazards & risk of swallowing batteries • Sound processors, 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. • Most sound processors can be supplied with a tamper resistant battery drawer upon request.
Warnings • If you drop the sound processor, make sure the shell is not cracked or any parts of the sound processor have broken. If you find something is wrong with your sound processor please contact your hearing care professional or local Oticon Medical representative. • Never dispose of your sound processor, its parts or batteries by burning them. There is a risk that they will explode and cause serious injury. Dispose the sound processor according to local regulation for electronic equipment.
• Although unlikely, nearby electronic devices may be affected by your sound processor. In that case, move the sound processor away from the affected electronic device. • Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation • The sound processor is MR Unsafe.
Warnings Dysfunction • Be aware of the possibility that your sound processor may stop working without notice. Keep this in mind when you depend on warning sounds (e.g. when you are in traffic). When wearing Ponto 5 Mini and an active implant • Caution must be taken with active implants. In general, follow the guidelines recommended by manufacturers of implantable defibrillators and pacemakers regarding use of mobile phones and magnets. • The sound processor contains a wireless transmitter.
• If you have an active brain implant, please contact the manufacturer of your implantable device for information about the risk of disturbance. • The sound processor contains a magnet. Caution must be taken with programmable CSF shunts. Follow the guidelines for required minimum distance recommended by the shunt manufacturer. Heat and chemicals • The sound processor must never be exposed to extreme heat e.g. left inside a parked car in the sun.
For USA only: Federal law restricts this device to sale by or on the order of a medical practitioner. • A prospective user of a bone anchored sound processor should always have a medical evaluation by a licensed physician to ensure that all medically treatable conditions that may affect hearing are identified and treated before a sound processor is purchased.
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.
Description of symbols and abbreviations used in this booklet ! Caution Consult instructions for use for warnings and precautions that are not found on the device itself. Manufacturer The device is produced by the manufacturer whose name and address are stated next to the symbol. CE mark The device complies with all required EU regulations and directives. The four digit number indicates the identification of the notified body.
Description of symbols and abbreviations used in this booklet Bluetooth logo Registered trademark of Bluetooth SIG, Inc. where any use of such requires a license. Made for Apple badges Indicates that the device is compatible with iPhone, iPad and iPod touch. Description of symbols and abbreviations used on device or packaging Electronic waste (WEEE) Waste from electronic equipment must be handled according to local regulations.
Description of additional symbols used on device or packaging Keep dry Indicates a medical device that needs to be protected from moisture. Consult instructions for use Consult instructions for use for warnings and cautions. Product Catalogue number Indicates the manufacturer’s catalogue number so that the medical device can be identified. Serial number Indicates the manufacturer’s serial number so that a specific medical device can be identified. YY.
Sound and LED light indicators Different sounds and light patterns indicate the hearing aid status. The different indicators are listed on the following pages. For light indicators on your charger, see the charger’s Instructions for use. Your hearing care professional can set sound and LED light indicators to match your preferences.
ON/OFF Sound LED light ON n Jingle n OFF n 4 descending tones n Volume Sound LED light Start-up volume n 2 tones n Minimum/maximum volume n 3 tones n Volume up/down n 1 tone n Mute activated on ON App, ConnectClip or Remote Control 3.
Accessories n Sound TV Adapter 3.
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