Sonova Phonak Audeo P User Manual
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Document Detail
Type: PDL
Document No.:
Owner:
Status:
Attributes
Attribute Type
Affected Site
DOC Product Family
DOC Project Deliverable
Category
DOC Regulatory
Applicability
DOC Regulatory
Applicability
DOC Regulatory
Applicability
Project
Project Phase
Approvals
Level Actor
1
Lora Braun
2
Daniel Holenstein
Revision Notes
Access Activity
Remark
PDL-748
Rev.: 1
029-0844-02 User Guide Audéo P-R/RT EN
Title:
11YBRUENGGER Yvonne Bruengger
CURRENT
Value
1100
<value>Audéo P</value></Tag
User Information
Technical File
Device Master Record (DMR)
Design History File (DHF)
Mozart RIC
Finished Product
Job Title
Default
Default
Note
Initial Document
Effective Date:
Expiration Date:
Sign-off Date
18-Mar-2020
18-Mar-2020
Accessed By
11YBRUENGGER
18-Mar-2020
18-Mar-2020
Description
Stafa (CH)
Sign-off By
11LBRAUN
11DHOLENSTEI
Accessed Date
18-Mar-2020
1

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Summary of Contents for Sonova Phonak Audeo P

  • Page 1 18-Mar-2020 Document Detail Type: PDL Effective Date: 18-Mar-2020 PDL-748 Expiration Date: Document No.: Rev.: 1 029-0844-02 User Guide Audéo P-R/RT EN Title: Owner: 11YBRUENGGER Yvonne Bruengger CURRENT Status: Attributes Attribute Type Value Description Affected Site 1100 Stafa (CH) DOC Product Family <value>Audéo P</value></Tag User Information DOC Project Deliverable...
  • Page 2 Phonak Audéo User Guide Phonak Audéo P-R/RT Phonak Audéo P-R/RT Trial...
  • Page 3 This user guide is valid for: Wireless hearing aids 2020 Phonak Audéo DPM-R 2020 2020 Phonak Audéo P90-R 2020 Phonak Audéo P90-RT 2020 Phonak Audéo P70-R 2020 Phonak Audéo P70-RT 2020 Phonak Audéo P50-R 2020 Phonak Audéo P50-RT 2020 Phonak Audéo P30-R 2020 Phonak Audéo P30-RT Phonak Audéo P-R Trial...
  • Page 4 Your hearing aid & charger details If no box is checked and you do not know the model of your hearing aid or charging accessories, please ask your hearing care professional. The hearing aids described in this user guide contain a built-in and non-removable rechargeable lithium-ion battery.
  • Page 5 Your hearing aids and chargers have been developed by Phonak – the world leader in hearing solutions based in Zurich, Switzerland. These premium products are the result of decades of research and expertise and are designed to keep you connected to the beauty of sound! We thank you for making such a great choice and wish you many years of listening pleasure.
  • Page 6 For any information regarding the repair service of the hearing aid or accessories please contact the hearing care professional. Phonak - life is on www.phonak.com...
  • Page 7: Table Of Contents

    Contents Your hearing aid and charger 1. Quick guide 2. Parts of the hearing aid & charger Using the charger 3. Preparing the charger 4. Charging the hearing aids Using the hearing aid 5. Left & right hearing aid markings 6.
  • Page 8 Further information 16. Operating, transport and storage conditions 17. Care and maintenance 18. Exchanging the earwax protection 19. Service and warranty 20. Compliance information 21. Information and description of symbols 22. Troubleshooting 23. Important safety information...
  • Page 9: Quick Guide

    1. Quick guide Charging your hearing aids Before using your hearing aid for the irst time, it is recommended to charge it for 3 hours. After placing your hearing aid in the charger, the indicator light will show the charging state of the battery until the hearing aid is fully charged.
  • Page 10 Multi-function button with indicator light The button has several functions. It functions as an on/of switch, a volume control and/or a program change depending on the hearing aid programming. This is indicated in your individual instructions. Phone calls: If paired with a Bluetooth® enabled phone, a short press will accept and a long press will reject an incoming call.
  • Page 11: Parts Of The Hearing Aid & Charger

    2. Parts of the hearing aid & charger The following pictures show the hearing aid model and charger accessories described in this user guide. You can identify your personal models by: • checking “Your hearing aid & charger details” on page 3.
  • Page 12 Charger Case Combi Cleaning tool Space for drying capsule (cover closed) Space for earpieces Hearing aid charging inserts with left/right indicators Space for drying capsule (cover open) Drying capsule (optional)
  • Page 13 Charger Case Combi with optional Power Pack Charger Case Combi Indicator light for power micro-USB connection to external power supply Power Pack micro-USB connection to external power supply Battery check button Indicator light for battery status and external power Power Pack lock and release...
  • Page 14 Mini Charger Case Hearing aid charging inserts with left/right indicators USB-C connection to external power supply Indicator light for power External power supply USB cable (< 3 m) Power supply...
  • Page 15: Preparing The Charger

    3. Preparing the charger Connecting the power supply a) Plug the larger end of the charging cable into the power supply. b) Plug the smaller end into the USB port on the charger. c) Plug the power supply into a power outlet. d) The indicator light is green when the charger is connected to the power supply.
  • Page 16: Charging The Hearing Aids

    4. Charging the hearing aids Low power: You will hear two beeps when the battery is low. You will have approximately 60 minutes before you have to charge the hearing aids (this can vary, depending on the hearing aid settings). The hearing aid contains a built-in and non- removable rechargeable lithium-ion battery.
  • Page 17 4.1 Using the Charger Case Combi or Mini Charger Case Please refer to chapter 3 for how to set up the charger. Insert the hearing aid into the charging inserts. Make sure the left and right hearing aid markings match the left (blue), right (red) indicators next to the charging inserts.
  • Page 19 The indicator light will show the charging state of the battery until the hearing aid is fully charged. When fully charged the indicator light will remain on, i.e. solid green light. The charging process will automatically stop when the batteries are fully charged, so the hearing aids can be safely left in the charger.
  • Page 21 Remove the hearing aids from the charging inserts by 1. pulling the hearing aids gently toward yourself and 2. lifting them out of the charger. Do not hold the tubes to remove the hearing aids from the charger as this can damage the tubes. The hearing aid switches on automatically when removed from the charger.
  • Page 23 4.2 Using the optional Power Pack Note: The Power Pack is only compatible with the Charger Case Combi. Attach the Power Pack to the bottom of the Charger Case Combi and lock it. Plug in the micro-USB and connect to an external power supply.
  • Page 24 micro-USB connection to external power source Indicator light battery status: 0%-29% • 30%-59% •• 60%-100% ••• Battery check push button Power Pack lock and release To check the remaining battery capacity of the Power Pack, press the battery check push button. The indicator lights will show the status.
  • Page 25: Left & Right Hearing Aid Markings

    5. Left & right hearing aid markings There is a red or blue marking on the back of the hearing aid and on the speaker. This will tell you if it is a left or a right hearing aid. Blue marking for left hearing aid.
  • Page 26: Putting On The Hearing Aid

    6. Putting on the hearing aid Place the hearing aid behind your ear. Insert the earpiece into your ear canal. If there is an anchor attached to the earpiece, tuck it into the bowl of your ear to secure your hearing aid.
  • Page 27: Removing The Hearing Aid

    7. Removing the hearing aid Pull on the bend of the tube and remove the hearing aid from behind the ear.
  • Page 28: Multi-Function Button

    8. Multi-function button The multi-function button has several functions. It functions as an on/of switch, a volume control and/or a program change depending on the hearing aid programming. This is indicated in your individual “Hearing aid instructions”. Please ask your hearing care professional for a printout.
  • Page 29: On/Of

    9. On/Of Switch on hearing aid The hearing aid is conigured to switch on automatically when removed from the charger. If this function is not conigured, irmly press and hold the lower part of the button for 3 seconds until the indicator light blinks.
  • Page 30: Tap Control

    10. Tap control Tap control is only available for models P90 and P70. If paired with a Bluetooth enabled device, multiple functions can be accessed using tap control e.g. accept/end phone call, pause/resume streaming, start/stop voice assistant. This is indicated in your individual “Hearing aid instructions”.
  • Page 31: Connectivity Overview

    11. Connectivity overview The illustration below shows the connectivity options available for your hearing aid. Bluetooth enabled device, e.g. cell phone TV Connector connected to TV* Roger** * The TV Connector can be connected to any audio source such as a TV, PC or hi-i system. ** Roger wireless microphones can be connected to your hearing aids as well.
  • Page 32: 2. Initial Pairing

    12. Initial pairing 12.1 Initial pairing to a Bluetooth® enabled device It is only necessary to perform the pairing procedure once with each device featuring Bluetooth wireless technology. After the initial pairing, your hearing aids will connect automatically to the device. Initial pairing can take up to 2 minutes.
  • Page 33 Your device shows a list of Bluetooth enabled devices. Select the hearing aid from the list to simultaneously pair both hearing aids. A beep conirms successful pairing. For more information about pairing instructions for Bluetooth wireless technology, speciic to some of the most popular phone manufacturers, go to: https://www.phonak.com/com/en/support.html 12.2 Connecting to the device...
  • Page 34: Phone Calls

    13. Phone calls Your hearing aids connect directly with Bluetooth® enabled phones. When paired and connected to your phone, you will hear the caller’s voice directly in your hearing aids. Your voice is picked up by the hearing aid microphones and transmitted to the phone. Your voice Caller’s voice Bluetooth®...
  • Page 35 13.1 Making a call Enter the phone number and press the dial button. You will hear the dialing tone through your hearing aids. Your voice is picked up by the hearing aid microphones and transmitted to the phone.
  • Page 36 13.2 Accepting a call When receiving a call, a calling notiication will be heard in the hearing aids. The call can be accepted by taping the top of your ear twice (only available for models P90 and P70), a short press on the upper or lower part of the multi-function button on the hearing aid (less than 2 seconds) or directly on your phone.
  • Page 37 13.3 Ending a call A call can be ended by taping the top of your ear twice (only available for models P90 and P70), a long press on the upper or lower part of the multi-function button on the hearing aid (more than 2 seconds) or directly on your phone.
  • Page 38 13.4 Rejecting a call An incoming call can be rejected by a long press on the upper or lower part of the multi-function button on the hearing aid (more than 2 seconds) or directly on your phone. long press > 2 sec...
  • Page 39: Flight Mode

    14. Flight mode Your hearing aids operate between 2.4 GHz–2.48 GHz frequency range. When lying some operators require all devices to be switched into light mode. Entering light mode will not disable normal hearing aid functionality, only the Bluetooth connectivity functions. 14.1 Enter light mode To disable the wireless function and enter light mode in each hearing aid:...
  • Page 40 If the hearing aid is turned of, proceed to Step 2. If the hearing aid is on, turn it of by pressing and holding the lower part of the button for 3 seconds, until the indicator light turns solid red for 2 seconds, signifying that the hearing aid is switching of.
  • Page 41 14.2 Exit light mode To enable the wireless function and exit light mode in each hearing aid: Switch the hearing aid of and then on again - refer to chapter 9.
  • Page 42: Rebooting Your Hearing Aid

    15. Rebooting your hearing aid Use this technique if your hearing aid is in an error state. This will not remove or delete any program or settings. Press the lower part of the button for at least 15 seconds. It does not matter if the hearing aid is switched on or of before you start pressing the button.
  • Page 43: Operating, Transport And Storage Conditions

    16. Operating, transport and storage conditions The product is designed such that it functions without problems or restrictions if used as intended, unless otherwise noted in these user guides. Please ensure to use, charge, transport and store the hearing aids and the Power Pack according to the following conditions: Charging Transport...
  • Page 44 Please ensure to charge the hearing aids and the Power Pack regularly during long-term storage. These hearing aids are classiied IP68 (depth of 1 meter for 60 minutes) and designed to be used in all daily life situations. Therefore you do not have to worry about getting the hearing aids exposed to a rain shower or sweat.
  • Page 45: Care And Maintenance

    Diligent and routine care of your hearing aid and chargers contribute to outstanding performance and a long service life. To ensure a long service life, Sonova AG provides a minimum of a ive year service period after phase out of the respective hearing aid.
  • Page 46 General information Before using hair spray or applying cosmetics, you should remove your hearing aid from your ear, because these products may damage it. Your hearing aids are resistant to water, sweat and dust under the following conditions: • After exposure to water, sweat or dust, the hearing aid is cleaned and dried.
  • Page 47 Daily Hearing aid: Inspect the earpiece for earwax and moisture deposit and clean the surfaces with a lint-free cloth. Never use cleaning agents such as household detergents, soap, etc. for cleaning your hearing aid. It is not recommended to rinse with water. If you need to clean your hearing aid intensively, ask your hearing care professional for advice and information on ilters or drying capsules.
  • Page 48: Exchanging The Earwax Protection

    18. Exchanging the earwax protection Your hearing aid is equipped with an earwax protection to protect the speaker from earwax damage. Please check the earwax protector regularly and exchange it if it looks dirty or if the hearing aid volume or sound quality is reduced.
  • Page 49 Gently pull of the earpiece to remove. Clean the speaker with a lint-free cloth.
  • Page 50 18.2 Exchanging the earwax protection with CeruShield™ Disk Gently rotate the CeruShield Disk in the direction indicated by the arrows until a free opening appears under the bin icon. To remove a used earwax protector carefully insert the speaker into the free opening (under bin icon) until it clicks.
  • Page 51 To insert a new earwax protector carefully insert the speaker into the opening where the new earwax protector is visible (opposite the bin icon) until it clicks. After the click you will see the opening below is empty and the new earwax protector is now inside the speaker.
  • Page 52 18.3 Attaching the earpiece to the speaker Hold the speaker in one hand and the earpiece in the other. Slide the earpiece over the speaker sound outlet. The speaker and the earpiece should it perfectly together.
  • Page 53: Service And Warranty

    International warranty Sonova AG ofers a one year limited international warranty, valid from the date of purchase. This limited warranty covers manufacturing and material defects in the hearing aid and chargers respectively, but not accessories such as tubes, earpieces, external receivers.
  • Page 54 Warranty limitation This warranty does not cover damage from improper handling or care, exposure to chemicals or undue stress. Damage caused by third parties or non-authorized service centers renders the warranty null and void. This warranty does not include any services performed by a hearing care professional in their oice.
  • Page 55: Compliance Information

    20. Compliance information Europe: Declaration of Conformity for the hearing aid Hereby Sonova AG declares that this product meets the requirements of the Medical Devices Directive 93/42/EEC as well as the Radio Equipment Directive 2014/53/EU. The full text of the EU Declaration of Conformity can...
  • Page 56 The wireless models listed on page 2 are certiied under: Phonak Audéo P-R & P-RT (P90/P70/P50/P30) Phonak Audéo P-R Trial & P-RT Trial FCC ID: KWC-MRP Canada IC: 2262A-MRP...
  • Page 57 Notice 2: Changes or modiications made to this device not expressly approved by Sonova AG may void the FCC authorization to operate this device. Notice 3: This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules and ICES-003 of Industry Canada.
  • Page 58 no guarantee that interference will not occur in a particular installation. If this device does cause harmful interference to radio or television reception, which can be determined by turning the equipment of and on, the user is encouraged to try to correct the interference by one or more of the following measures: •...
  • Page 59 Radio information of your wireless hearing aid Antenna type Resonant loop antenna Operation frequency 2.4 GHz – 2.48 GHz Modulation GFSK, Pi/4 DPSK, GMSK Radiated power < 2.5 mW Bluetooth® Range ~1 m Bluetooth 4.2 Dual-Mode Proiles supported HFP (Hands-free proile), A2DP...
  • Page 60 Compliance with emission and immunity standards Emission standards EN 60601–1-2:2015 IEC 60601–1-2:2014 EN 55011:2009+A1 CISPR11:2009/AMD1:2010 CISPR22:1997 CISPR32:2012 ISO 7637-2:2011 CISPR25:2016 EN 55025:2017...
  • Page 61 Immunity standards EN 60601-1-2:2015 IEC 60601-1-2:2014 EN 61000-4-2:2009 IEC 61000-4-2:2008 EN 61000-4-3:2006+A1+A2 IEC 61000-4-3:2006+A1+A2 EN 61000-4-4:2012 IEC 61000-4-4:2012 EN 61000-4-5:2014 IEC 61000-4-5:2014 EN 61000-4-6:2014 IEC 61000-4-6:2013 EN 61000-4-8:2010 IEC 61000-4-8:2009 EN 61000-4-11:2004 IEC 61000-4-11:2004 IEC 60601-1 (§ 4.10.2):2005 ISO 7637-2:2011...
  • Page 62: Information And Description Of Symbols

    21. Information and description of symbols With the CE symbol, Sonova AG conirms that this product – including accessories – meets the requirements of the Medical Devices Directive 93/42/EEC as well as the Radio Equipment Directive 2014/53/EU. The numbers after the...
  • Page 63 US Federal Communications Commission. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Sonova AG is under license. Other trademarks and trade names are those of their respective owners.
  • Page 64 Japanese mark for certified radio equipment. Indicates the manufacturer’s serial number so that a speciic medical device can be identiied. Indicates the manufacturer’s catalogue number so that the medical device can be identiied. Indicates that the device is a medical device. This symbol indicates that it is important for the user to read and take into account the relevant information in this user guide.
  • Page 65 Humidity during storage: 0% to 70%, if not in use. See instruction in chapter 23.2 regarding drying the hearing aid after use. Atmospheric pressure during transportation and storage: 500 hPa to 1060 hPa During transportation keep dry. The symbol with the crossed-out garbage bin is to make you aware that this hearing aid as well as chargers and Power Pack may not be thrown away as normal household waste.
  • Page 66 Symbols applicable to the European power supply only Power supply with double isolation. Device designed for indoor use only. Safety isolating transformer, short circuit proof.
  • Page 67: Troubleshooting

    Troubleshooting Problem Causes Hearing aid not Speaker/earpiece blocked functioning Hearing aid switched of Battery fully discharged Hearing aid whistles Hearing aid not inserted correctly into ear Cerumen in ear canal Hearing aid too loud Volume too loud Hearing aid not loud Volume too low enough or distorted Low battery...
  • Page 68 What to do Clean speaker opening/earpiece Press lower part of multi-function button for 3 seconds (chapter 9) Charge hearing aid (chapter 4) Insert hearing aid correctly (chapter 6) Contact your ENT/GP or hearing care professional Decrease volume if volume control available (chapter 8) Increase volume if volume control available (chapter 8) Charge hearing aid (chapter 4) Clean speaker opening/earpiece...
  • Page 69 Problem Causes Indicator light on hearing Dirty charging contacts aid is solid red while Hearing aid is out of its operating hearing aid is in the temperature range charger Faulty battery Indicator light on hearing “Auto On” feature is disabled aid switches of when hearing aid is removed from charger...
  • Page 70 What to do Clean the contacts of the hearing aid and the charger Warm hearing aid up. Operating temperature range is +5° to +40° Celsius (+41° to +104° Fahrenheit) Contact your hearing care professional Switch on the hearing aid (chapter 9) Reboot the hearing aid (chapter 15) Contact your hearing care professional.
  • Page 71: Important Safety Information

    23. Important safety information Please read the information on the following pages before using your hearing aid. Intended use: The hearing aid is intended to amplify and transmit sound to the ear and thereby compensate for impaired hearing. The Phonak Tinnitus Balance software feature is intended for use by people with tinnitus who also desire ampliication.
  • Page 72 A hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. Infrequent use of a hearing aid does not permit a user to attain full beneit from it. The use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading.
  • Page 73 Any serious incident that has occurred in relation to the hearing aid, should be reported to the manufacturer representative and the competent authority of the state of residence. The serious incident is described as any incident that directly or indirectly led, might have led or might lead to any of the following: a) the death of a patient, user or other person b) the temporary or permanent serious deterioration of...
  • Page 74 They should not be used by any other person as they could damage hearing. Changes or modiications to the hearing aid that were not explicitly approved by Sonova AG are not permitted. Such changes may damage your ear or the hearing aid.
  • Page 75 Do not use the hearing aids and charging accessories in explosive areas (mines or industrial areas with danger of explosions, oxygen rich environments or areas where lammable anesthetics are handled) or where electronic equipment is prohibited. If you feel pain in or behind your ear, if it is inlamed or if skin irritation and accelerated accumulations of earwax occur, please check with your hearing care professional or physician.
  • Page 76 Hearing programs in the directional microphone mode reduce background noises. Please be aware that warning signals or noises coming from behind, e. g. cars, are partially or entirely suppressed. This hearing aid is not for children below 36 months. The usage of this device by children and individuals with cognitive impairment should be supervised at all times to ensure their safety.
  • Page 77 Do not cover the whole charger cases while charging, e.g. with a cloth etc. The following is only applicable for persons with active implantable medical devices (i.e. pacemakers, deibrillators, etc.): • Keep the wireless hearing aid at least 15 cm (6 inches) away from the active implant.
  • Page 78 Use of accessories, transducers and cables other than those speciied 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. 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 the hearing aids, including cables speciied by the manufacturer.
  • Page 79 Hearing aids should not be itted with domes / wax protection systems when used by clients with perforated eardrums, inlamed ear canals or otherwise exposed middle ear cavities. In these cases, we recommend the use of a custom earpiece. In the unlikely case that any part of this product should remain in the ear canal, it is strongly recommended to see a medical specialist for safe removal.
  • Page 80 23.2 Information on product safety These hearing aids are water resistant and not waterproof. They are designed to withstand normal activities and occasional accidental exposure to extreme conditions. Never immerse your hearing aid in water! These hearing aids are not speciically designed for extended periods of water submersion on a continual basis, that is worn in activities such as swimming or bathing.
  • Page 81 Do not place the charging accessories close to an induction cooking surface. Conductive structures inside the charging accessories could absorb inductive energy resulting in thermal destruction. The dome should be changed every three months or when it becomes stif or brittle. This is to prevent the dome from detaching from the tube spout during insertion into or removal from the ear.
  • Page 82 Special medical or dental examination including radiation described below, may adversely afect the correct functioning of your hearing aids. Remove and keep them outside the examination room/area before undergoing: • Medical or dental examination with X-ray (also CT scan). • Medical examinations with MRI/NMRI scans, generating magnetic ields.
  • Page 83 Your hearing aid(s) contain a lithium-ion battery and the Power Pack contains a lithium-polymer battery, both with a Watt hour rating <20 Wh which have been tested according to UN 38.3 of the “UN Manual of Tests and Criteria” and should be shipped in accordance with all the rules and regulations on the safe shipment of lithium-ion and lithium- polymer batteries.
  • Page 84 Notes...
  • Page 85 Your hearing care professional: Manufacturer: Sonova AG Laubisrütistrasse 28 CH-8712 Stäfa Switzerland www.phonak.com Sonova Deutschland GmbH Max-Eyth-Str. 20 DE-70736 Fellbach-Oeingen Germany...

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