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Phonak Audeo P-R Fit User Manual
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Phonak Audeo P-R Fit User Manual

Phonak Audeo P-R Fit User Manual

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Phonak Audéo Fit
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User Guide
Phonak Audéo P-R Fit
Phonak Audéo P-R Fit Trial

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Summary of Contents for Phonak Audeo P-R Fit

  • Page 1 Phonak Audéo Fit User Guide Phonak Audéo P-R Fit Phonak Audéo P-R Fit Trial...
  • Page 2 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. The Compliance Identification Mark indicates that the device is in accordance with Brazilian conformity assessment requirements for equipment under health...
  • Page 3 Indicates the manufacturer’s serial number so that a specific medical device can be identified. Indicates the manufacturer’s serial number so that a specific medical device can be identified. 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 4 Ingress Protection Rating. IP68 rating indicates that the hearing aid is water and dust resistant. It survived continuous immersion in 1 meter of fresh water for 60 minutes and 8 hours in a dust chamber as per the IEC60529 standard Temperature during transportation and storage: –20°...
  • Page 5 The symbol with the crossed-out garbage bin is to make you aware that this hearing aid as well as the charger may not be thrown away as normal household waste. Please dispose of old or unused hearing aids and charger, at waste disposal sites intended for electronic waste, or give your hearing aid and charger to your hearing care professional for...
  • Page 6 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 7: Troubleshooting

    15 seconds Indicator light on hearing Hearing aid not inserted correctly aid does not light up when into charger hearing aid placed in Charger not connected to power source charging inserts Battery fully discharged Please check https://www.phonak.com/com/en/support.html for further information.
  • Page 8 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 9 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 off when hearing aid is removed from charger...
  • Page 10 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 16) Contact your hearing care professional.

  • Page 11: Important Safety Information

    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 amplification. It provides supplementary noise stimulation which can help defocus the user`s attention from their tinnitus.
  • Page 12 Intended patient population: Hearing aids: This device is intended for patients with unilateral and bilateral, mild to severe hearing loss from 12 years of age. The tinnitus software feature is intended for patients with chronic tinnitus from 18 years of age. Chargers and Power Pack: The intended patient population is the user of the compatible hearing aids Intended user:...
  • Page 13 Indications: General clinical indications for the use of hearing aids and Tinnitus software feature are: • Presence of hearing loss • Uni- or bilateral • Conductive, sensorineural or mixed • Mild to severe • Presence of a chronic tinnitus (only applicable for devices which provide the Tinnitus software feature) Chargers and Power pack: Please note, indications are not derived from the chargers and Power Pack, but from the...
  • Page 14 The primary criteria for the referral of a patient for a medical or other specialist opinion and / or treatment are as follows: • Visible congenital or traumatic deformity of the ear; • History of active drainage from the ear in the previous 90 days;...
  • Page 15 The HCP may decide that referral is not appropriate or in the best interests of the patient when the following applies: • When there is sufficient evidence that the condition has been fully investigated by a medical specialist and any possible treatment has been provided; •...
  • Page 16 Charger and Power Pack: The Chargers and Power Pack itself do not provide a direct clinical benefit. An indirect clinical benefit is provided by enabling the parent device (rechargeable hearing aids) to achieve their intended purpose Clinical benefit: Hearing aids: Improvement of speech understanding. Charger and Power Pack: The Chargers and Power Pack itself do not provide a direct clinical benefit.
  • Page 17 Conventional hearing aids have the potential to expose patients to higher levels of sound exposure, which might result in threshold shifts in the frequency range affected by acoustic trauma. Chargers and Power Pack: Please note, side effects are not derived from the chargers and Power Pack, but from the compatible hearing aids.
  • Page 18 Feedback, poor sound quality, too loud or too soft sounds, inadequate fitting or problems when chewing or swallowing, can be resolved or improved during the fine-tuning process at the fitting procedure by your hearing care professional. 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.
  • Page 19 24.1 Hazard warnings The rechargeable hearing aids and the Power Pack contain lithium-ion batteries that can be taken onto airplanes as carry-on luggage. The hearing aids and the Power Pack cannot be placed in the checked-in baggage and can only be placed in the carry-on luggage.
  • Page 20 Do not use the device in explosive areas (mines or industrial areas with danger of explosions, oxygen-rich environments or areas where flammable anesthetics are handled).The device is not ATEX certified.. If you feel pain in or behind your ear, if it is inflamed or if skin irritation and accelerated accumulations of earwax occur, please check with your hearing care professional or physician.
  • Page 21 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. The hearing aid is a small device and contains small parts.
  • Page 22 • Keep magnets (i.e. EasyPhone magnet, etc.) at least 15 cm (6 inches) away from the active implant. • If using a Phonak wireless accessory, consult the chapter “Important safety information” in your wireless accessory user guide.
  • Page 23 Do not remove receiver cables from the hearing instruments. If removal or exchange is required it is recommended to contact the hearing care professional. 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 specified by the manufacturer.
  • Page 24 Hearing aids should not be fitted with domes / wax protection systems when used by clients with perforated eardrums, inflamed 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 25: Information On Product Safety

    24.2 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 specifically designed for extended periods of water submersion on a continual basis, that is worn in activities such as swimming or bathing.
  • Page 26 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 stiff or brittle. This is to prevent the dome from detaching from the tube spout during insertion into or removal from the ear.
  • Page 27 • Medical or dental examination with X-ray (also CT scan). • Medical examinations with MRI/NMRI scans, generating magnetic fields. Hearing aids don’t need to be removed when passing security gates (airports etc.). If X-ray is used at all, it will be in very low doses, and will not affect the hearing aids.
  • Page 28 rules and regulations on the safe shipment of lithium-ion batteries..
  • Page 29 Your hearing care professional: Australian Sponsor: Sonova Deutschland Sonova Australia Pty Ltd GmbH 12 Inglewood Place, Max-Eyth-Strasse 20 Norwest NSW 2153 70736 Fellbach-Oeffingen Australia Germany Manufacturer: Sonova AG Laubisrütistrasse 28 CH-8712 Stäfa Switzerland www.phonak.com...

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Audeo p-r fit trial