Sentio 1 Mini Instructions for Use Sound processor
The Instructions for Use The Sentio System is intended for improvement of hearing for patients with conductive and mixed hearing losses by unilateral or bilateral fitting, and single sided deafness. The system comprises of an implant and an externally worn sound processor. The implant is placed fully under the skin and the sound processor is retained to the implant site with a magnet. The Sentio 1 Mini sound processor is designed to be optimised for each individual person.
Please read through this manual carefully to learn how to get the most out of your sound processor. Pay extra attention to Warnings section, Important information, Skin care and retention comfort and Sound Processor maintenance. Discuss any questions or concerns with your hearing care professional. Summary of Safety and Clinical Performance (SSCP) report for the Sentio System is publicly available in the EUDAMED database.1 1 https://ec.europa.eu/tools/eudamed.
The Instructions for Use.......................................................................................3 In the box............................................................................................................8 Processor view....................................................................................................9 The Sentio 1 bone conduction hearing system.................................................... 10 Switching the sound processor ON and OFF .......................
Use the sound processor with iPhone and iPad ..................................................28 Pairing the sound processor with iPhone............................................................29 Wireless accessories......................................................................................... 31 Sentio 1 compatible with the following articles................................................... 32 Service and repair...............................................................................
In the box • • • • • • 8 Sentio 1 Mini sound processor Sentio 1 Mini case Batteries (size 675) Safety line Left/right indication (blue/red) Tamper resistant battery lid tool
Processor view Push button LED (light diode) Microphone inlets Magnet Battery lid Hole for TAR Hole for TAR Hole for Safety line Warning: The sound processor contains small parts that may be a choking hazard for small children. 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 Sentio bone conduction hearing system Your Sentio 1 Mini sound processor is designed to help you gain improved hearing through direct bone conduction. The sound processor converts sound into signals which are transmitted to the Sentio Ti Implant where they are converted into vibrations. The vibrations pass through the skull bone to the inner ear where they are perceived as sound. This works independently of the function of the ear canal and middle ear.
Sound processor Implant Sound processor Implant under the skin 11
Switching the sound processor ON and OFF Insert or remove the battery to switch the sound processor ON or OFF. To save battery life, make sure your sound processor is switched off when you are not wearing it. Switch OFF Remove the battery lid and battery to switch the sound processor off Switch ON Insert the battery and put on the battery lid to start up the sound processor Optional LED Two long green flashes indicate that the sound processor is turned on.
Tamper-resistant battery lid Sentio 1 Mini comes with a built-in tamper-resistant battery lid. To lock the tamperresistant battery lid, insert the tip of the TAR tool into the hole on the back of the battery lid and push lightly. Check that the lid cannot be opened to confirm that the TAR mechanism is locked. Insert the tip of the TAR tool from the front to unlock the tamper-resistant battery lid.
When to replace the battery The battery lifetime varies with usage time and sound environment. When it is time to replace the battery, you will hear three consecutive beeps repeated in moderate intervals. Four beeps in a descending tone indicate that the battery is running completely out. When the battery runs low, Bluetooth® will be turned off and it will not be possible to use wireless accessories.
How to replace the battery Sentio 1 Mini uses a size 675 zinc-air battery. Use high-quality zinc-air batteries for optimal performance. 1. Open Remove the battery lid from the sound processor. Warning: The sound processor contains small parts that may be a choking hazard for small children. Batteries can also be harmful if swallowed. Always keep batteries out of reach of small children or people of diminished mental capacity.
2. Uncover 3. Insert 4. Close Remove the sticky label from the + side of the new battery. Insert the new battery into the battery drawer. Make sure the + side is facing upwards. Close the battery lid. The sound processor will play a jingle. The jingle is played when the battery is inserted, unrelated to the lid. Note: Wait 2 minutes so that the battery can draw air, to ensure optimal functioning. 16 Note: If the battery is inserted incorrectly it may damage the battery compartment.
Left or right marking The Sentio 1 Mini devices are non-side specific and will be programmed to the left or right side by your hearing care professional. When using two sound processors, left and right indication plugs can be inserted under the battery lid. Your hearing care professional can apply these.
Connection The Sentio 1 Mini sound processor is retained to the implant under the skin by magnetic force. To attach the sound processor to the head, place it close to the implant site to allow the magnet in the sound processor to attract to the magnet in the implant. Note: No other magnet than your Sentio sound processor shall be placed over the implant site. This may damage the implant and/or your skin. Disconnection The sound processor is disconnected by carefully sliding it away from the implant.
Microphones Correct position Incorrect position 19
Skin care and retention comfort The sound processor should sit comfortably and securely in place with the right balance between comfort and retention. If the magnetic force is too weak there is a risk of the sound processor falling off too easily. If the magnetic force is too strong there is a risk of discomfort and skin irritation. If the sound processor causes redness or discomfort, or if the sound processor seems to fall off frequently, contact your hearing care professional to have the magnet exchanged.
Sound processor maintenance Always keep your sound processor in its case when not in use to protect it from dust and dirt. Your sound processor is dust tight and protected against ingress of water, designed to be worn in daily life situations. However, the sound processor is not waterproof and must never be washed or immersed in water or other liquids. If the sound processor accidentally gets wet, take off the battery lid, remove the battery and let the sound processor dry.
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.
How to attach safety line to the sound processor: 1. Pass the loop of the safety line through the attachment hole in the battery lid 2. Then pass the loop through the attachment hole in the sound processor 3. Insert the sound processor through the loop of the safety line and tighten 4. Attach the safety line clip to your clothing. Make sure the safety line is not pulled, as the sound processor could be disconnected. 1. 2. 3. 4. 5.
Volume control The volume can be adjusted on the double push button. Use a short press to adjust the volume. When worn on the head, the front-facing button turns the volume up, and the back-facing button turns the volume down. You will hear a tone when you increase or decrease the volume. The volume can also be controlled from a Bluetooth-connected device, e.g. smartphone or connectivity products.
Programmes Your sound processor can have up to four different programmes. These are programmed by your hearing care professional. Press the double push button to switch between programmes. Use a long press (two sec.). If the front-facing push button is pressed, the programme cycle switches one programme forward, for example from programme 1 to 2. If the back-facing push button is pressed, the programme cycle goes backwards, for example from programme 2 to 1.
Mute Use the mute function if you need to silence the sound for shorter periods of time while wearing the sound processor. Your sound processor can be muted by pressing either end of the push button for at least three seconds until a jingle is heard. Optional LED (can be turned on by your hearing care professional) Continuous green and orange flashes indicate mute.
Flight mode When flight mode is activated, Bluetooth® is turned off. The sound processor will still be working. Activate or deactive Flight mode by pressing either the front- or back-facing part of the double push button for seven seconds. After a few seconds you will hear a jingle that indicates Mute mode. Keep pressing the button until a final jingle is heard which confirms your action. Removing and reinserting the battery will also deactivate Flight mode. A short jingle confirms your action.
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 “Accessibility”. On the “Accessibility” screen, choose “Hearing Devices”. Open the battery lid and remove the battery. Re-insert the battery and close the battery lid 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. 30 Pair Here you can see the options for your sound processor.
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. TV Adapter 3.0 TV Adapter is a wireless transmitter of sound from TV and electronic audio devices. The TV Adapter streams sound directly to your sound processor.
Sentio 1 compatible with the following articles Description Article Sentio Ti Implants Genie Medical BAHS 23.1 or later ConnectClip Oticon Medical Sentio Implants Oticon Medical accessories Oticon A/S accessories TV Adapter 3.0 Remote Control 3.
Service and repair If your Sentio 1 Mini sound processor does not function properly, please contact your clinic to get it checked.
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.
Common problems and their possible solutions Symptom No sound Intermittent or reduced sound Whistling noise Sound processor falls off frequently Possible causes Solutions Worn-out battery Change battery Sound processor is muted Unmute or reset the sound processor by removing and reinserting the battery Dirt in the sound inlet Refer to Sound processor maintenance Moisture Take off the battery lid, remove the battery, let the sound processor dry Worn-out battery Change battery Sound processor
Common problems and their possible solutions Symptom Discomfort or skin being affected at sound processor site Possible causes Solutions Magnet strength too strong Contact your hearing care professional to have the magnet strength evaluated and exchanged if relevant In case of significant skin irritation, blistering, or signs of skin breakdown, you should stop wearing the device and seek assistance from a medical professional to assess your implant site.
Important information • It is important to follow the skin care 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. • Whenever the sound processor is not in use, ensure it is switched off by removing the battery lid and battery. The battery lid should be kept off to allow any moisture in the sound processor to evaporate. • The expected service life of the sound processor is 5 years.
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.
In the case of a serious incident in relation to the Sentio 1 Mini sound processor, the incident should be reported to the manufacturer as well as the local competent authority on safety and health. 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.
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. • 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.
• Electromagnetic interference may occur in the vicinity of equipment with the symbol to the right. Portable and mobile RF (radio frequency) communications equipment can affect the performance of your sound processor. If your sound processor is affected by electromagnetic interference, move away from the source to reduce the interference. • Retention properties of sound processor’s magnet can be degraded after exposure to strong magnetic fields.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 Inches) to any part of Sentio 1 sound processor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could be the result. • The sound processor is MR Unsafe. If you need to undergo MRI (Magnetic Resonance Imaging), the sound processor must be disconnected. The implant can remain in place.
• Consult your hearing care professional if you experience unexpected operations or events with your sound processor. 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.
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). Contact your Hearing care professional as soon as possible. When wearing Sentio 1 Mini and any type of active implants • 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.
Heat and chemicals • The sound processor must never be exposed to extreme heat e.g. left inside a parked car in the sun. • The sound processor must not be dried in microwave ovens or other ovens.
Operating conditions Temperature: +1°C to +40°C Relative humidity: 5% to 93%, non-condensing Atmospheric pressure: 700 hPa to 1060 hPa Storage and transportation conditions Temperature and humidity should not exceed the following limits for extended periods during transportation and storage.
• The audiologist or hearing instrument dispenser will conduct a hearing instrument evaluation to assess your ability to hear with and without a hearing instrument. The hearing instrument evaluation will enable the audiologist or dispenser to select and fit a hearing instrument 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 programme.
Symbol clarifications 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 sound processor status. The different indicators are listed on the following pages. Your hearing care professional can set sound and LED light indicators to match your preferences.
ON/OFF Sound LED light ON n Start-up jingle n OFF n 4 descending tones n Volume Sound LED light Start-up volume n 2 beeps n Minimum/maximum volume n 3 beeps n Volume up/down n 1 beep n Mute activated on App, ConnectClip or Remote Control 3.
Accessories n Sound TV Adapter 3.
UK Responsible Person: Oticon Limited Cadzow Industrial Estate Hamilton ML3 7QE United Kingdom 247667UK Oticon Medical AB Datavägen 37B SE-436 32 Askim Sweden Tel: +46 31 748 61 00 www.oticonmedical.
