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Oticon Medical Sentio 1 Mini Instructions For Use Manual

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Sentio 1 Mini
Instructions for Use
Sound processor

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Summary of Contents for Oticon Medical Sentio 1 Mini

  • Page 1 Sentio 1 Mini Instructions for Use Sound processor...

  • Page 3: The Instructions For Use

    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 per- son. This will help ensuring you get the maximum benefit from your sound processor.
  • Page 4 Summary of Safety and Clinical Performance (SSCP) report for the Sentio System is publicly available in the EUDAMED database. https://ec.europa.eu/tools/eudamed. Entering key Sentio Ti Implant: Entering key Sentio 1 Mini sound processor: Basic UDI-DI: 57121491001083 Basic UDI-DI: 57121491001185...

  • Page 5: Table Of Contents

    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 ............12 When to replace the battery ................13 How to replace the battery ................14 Left or right marking ..................17 Connection ......................
  • Page 6 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 .................... 33 Manufacturer’s warranty ...................34 Common problems and their possible solutions ..........35 Important information ..................

  • Page 8: In The Box

    In the box • Sentio 1 Mini sound processor • Sentio 1 Mini case • Batteries (size 675) • Safety line • Left/right indication (blue/red) • Tamper resistant battery lid tool...

  • Page 9: Processor View

    Processor view Push button LED (light diode) Microphone Magnet inlets 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.

  • Page 10: The Sentio 1 Bone Conduction Hearing System

    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 vibra- tions.
  • Page 11 Sound processor Implant Sound processor Implant under the skin...

  • Page 12: Switching The Sound Processor On And Off

    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 ON Switch OFF Insert the Remove the...
  • Page 13 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.

  • Page 14: When To Replace The Battery

    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.

  • Page 15: How To Replace The Battery

    How to replace the battery Sentio 1 Mini uses a size 675 zinc-air battery. 1. Open Use high-quality zinc-air batteries for optimal performance. Remove the battery lid from the sound processor. Warning: The sound processor contains small parts that may be a choking hazard for small children.
  • Page 16 2. Uncover 3. Insert 4. Close Remove the sticky label Insert the new battery Close the battery lid. from the + side of the into the battery drawer. The sound processor will new battery. Make sure the + side is play a jingle.

  • Page 17: Left Or Right Marking

    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.

  • Page 18: Connection

    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.
  • Page 19 Microphones Correct position Incorrect position...

  • Page 20: Skin Care And Retention Comfort

    Skin care and retention comfort The sound processor should sit comfortably and securely in place with the right bal- ance 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.

  • Page 21: Sound Processor Maintenance

    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.

  • Page 22: Optional Features And Accessories

    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.
  • Page 23 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.

  • Page 24: Volume Control

    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.

  • Page 25: Programmes

    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.

  • Page 26: Mute

    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.

  • Page 27: Flight Mode

    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.

  • Page 28: Use The Sound Processor With Iphone And Ipad

    Use the sound processor with iPhone and iPad Your sound processor is a Made for iPhone device and allows for direct communica- ® tion and control with iPhone, iPad or iPod touch . For assistance in using these prod- ® ®...

  • Page 29: Pairing The Sound Processor With Iphone

    Pairing the sound processor with iPhone 1. Settings 2. Accessibility 3. Turn on Bluetooth Hearing Devices Accessibility Open your iPhone and go On the “Accessibility” Open the battery lid and to “Settings”. Make sure screen, choose “Hearing remove the battery. Re-insert Bluetooth is on.
  • Page 30 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 Pair Check if your iPhone Here you can see the has detected your sound options for your sound processor.

  • Page 31: Wireless Accessories

    Wireless accessories Your sound processor offers wireless connection to a range of wireless accessories. ConnectClip TV Adapter 3.0 When ConnectClip is paired with your TV Adapter is a wireless transmitter of mobile phone, you can use the sound sound from TV and electronic audio processor as a handsfree headset.

  • Page 32: Sentio 1 Compatible With The Following Articles

    Sentio 1 compatible with the following articles Description Article Sentio Ti Implants Genie Medical BAHS 23.1 or later ConnectClip Oticon Medical Sentio Implants TV Adapter 3.0 Oticon Medical accessories Oticon A/S accessories Remote Control 3.0 Oticon app EduMic...

  • Page 33: Service And Repair

    Service and repair If your Sentio 1 Mini sound processor does not function properly, please contact your clinic to get it checked. Contact person at the Audiology Clinic – name and contact information: Contact person at the ENT Clinic – name and contact information:...

  • Page 34: Manufacturer's Warranty

    Manufacturer’s warranty Oticon Medical sound processors are covered by a limited warranty issued by the manu- facturer 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.

  • Page 35: Common Problems And Their Possible Solutions

    Common problems and their possible solutions Solutions Symptom Possible causes Worn-out battery Change battery Sound processor is muted Unmute or reset the sound No 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...
  • Page 36 Common problems and their possible solutions Solutions Symptom Possible causes Magnet strength too strong Contact your hearing care professional to have the magnet strength evaluated and exchanged if relevant In case of significant skin Discomfort or skin being irritation, blistering, or signs affected at sound processor site of skin breakdown, you should stop wearing the device and...

  • Page 37: Important Information

    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.

  • Page 38: Regulatory Compliance Statements

    Regulatory compliance statements his 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: This device may not cause harmful interference. This device must accept any interference received, including interference that may cause undesired operation of the device.
  • Page 39 • Consult the dealer or an experienced radio/TV technician for help. The legal manufacturer hereby declares that this Sentio 1 Mini is in compliance with the essential requirements and other relevant provisions of the Radio Equipment Directive 2014/53/EU. Declaration of conformity is available at: Oticon Medical AB.
  • Page 40 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.

  • Page 41: 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.
  • Page 42 • Electromagnetic interference may occur in the vicinity of equipment with the symbol to the right. Portable and mobile RF (radio frequency) commu- nications 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.
  • Page 43 • 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 manufac- turer. Otherwise, degradation of the performance of this equipment could be the result.
  • Page 44 • 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.
  • Page 45 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 rec- ommended by manufacturers of implantable defibrillators and pacemakers regard- ing use of mobile phones and magnets.
  • Page 46 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.
  • Page 47 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. Temperature: -25°C to +55°C Relative humidity: 5% to 93%, non-condensing Atmospheric pressure: 700 hPa to 1060 hPa For USA only: Federal law restricts this device to sale by or on the order of a medical...
  • Page 48 • 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.

  • Page 49: Symbol Clarifications

    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.
  • Page 50 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.
  • Page 51 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.

  • Page 52: Sound And Led Light Indicators

    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. Programme Sound LED light* When to use...
  • Page 53 ON/OFF Sound LED light LED light comments Start-up jingle 4 descending tones Volume Sound LED light Shown once Start-up volume 2 beeps Minimum/maximum 3 beeps volume Volume up/down 1 beep Mute activated on App, Continuous or repeated ConnectClip or Remote three times Control 3.0 Long GREEN blink...
  • Page 54 LED light Accessories Sound LED light comments TV Adapter 3.0 or 2 different tones Continuous or EduMic repeated three times ConnectClip 2 different tones Warnings Sound LED light LED light comments Continuously 3 alternate Low battery blinking tones 4 descending Battery shut down tones Microphone service...
  • Page 56 Oticon Medical AB UK Responsible Person: Oticon Limited Datavägen 37B SE-436 32 Askim Cadzow Industrial Estate Sweden Hamilton ML3 7QE Tel: +46 31 748 61 00 United Kingdom www.oticonmedical.com...

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