Phonak CROS P User Manual
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Phonak CROS P User Manual

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Phonak CROS P
User Guide
Phonak CROS P-13

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Summary of Contents for Phonak CROS P

  • Page 1 Phonak CROS P User Guide Phonak CROS P-13...
  • Page 2 This user guide is valid for: CE mark applied CROS device model Phonak CROS P-13 2021...
  • Page 3 Your CROS device operates between 2.4 GHz–2.48 GHz frequency range. When flying please check if flight operator requires devices to be switched into flight mode, see chapter 11. CROS device models Battery size CROS P-13 Earpieces Dome SlimTip CROS Tip...
  • Page 4 Your CROS device have been developed by Phonak – a 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 5 For more information regarding features, benefits, set up, use, maintenance or repairs of your CROS device and accessories, please contact your hearing care professional or the manufacturer representative. Additional information can be found in the datasheet of your product. Phonak – life is on www.phonak.com...

  • Page 6: Table Of Contents

    Contents Your CROS device Quick guide Parts of the CROS device Using the CROS device Left & right CROS device markings On/Off Batteries Putting on the CROS device Removing the CROS device Multi-function button Connectivity overview 10. Initial pairing 11. Phone calls 12.
  • Page 7 Further Information 13. Operating, transport and storage conditions 14. Care and maintenance 15. Exchanging the earpice from the tube 16. Service and warranty 17. Compliance information 18. Information and description of symbols 19. Troubleshooting 20. Important safety information 21. For the US market only, complies with the FDA regulations...

  • Page 8: Quick Guide

    1. Quick guide Left & right markings Blue marking for left side. Red marking for right side Changing batteries Remove the Open the Place battery in sticker from the new battery door. the battery door battery and wait two with the “+” minutes.
  • Page 9 On/Off Multi-function button The button has several functions. It functions as a volume control in the absence of wireless transmission of sound from the CROS device to the hearing aid, a balance control when there is a wireless transmission of sound from the CROS device to the hearing aid and/or a program change depending on the CROS device programming.

  • Page 10: Parts Of The Cros Device

    Phonak hearing aid on the other ear. Phonak CROS device + Phonak hearing aid = Phonak CROS system Phonak CROS P only works in connection with a Phonak Audéo™ P hearing aid as the receiver.
  • Page 11 Possible earpieces Dome SlimTip CROS TIP CROS P-13 Multi-function button Tube Battery door Speaker dummy Anchor (optional) (without earpiece attached)

  • Page 12: Left & Right Cros Device Markings

    3. Left & right CROS device markings There is a red or blue marking on the back of the CROS device and on the speaker dummy. This will tell you if the CROS device is meant to be worn on the left or the right Blue marking for left side.

  • Page 13: On/Off

    4. On/Off The battery door is also the on/off switch. Closed battery door = CROS device is on Open battery door = CROS device is off When you switch on the CROS device you might hear a start-up melody in the hearing aid.

  • Page 14: Batteries

    5. Batteries Remove the Open the Place battery in sticker from the battery door. the battery door new battery and with the “+” wait two minutes. symbol facing upwards. If it is difficult to close the battery door, check that the battery is inserted correctly and the “+” symbol is facing upwards.
  • Page 15 Color ANSI battery marking on code code size package Phonak CROS P-13T orange PR48 7000ZD Please ensure you use the correct type of battery in your CROS device (zinc-air). Please also read chapter 20.2 for further information on product safety.

  • Page 16: Putting On The Cros Device

    6. Putting on the CROS device Place the CROS device 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 CROS device.

  • Page 17: Removing The Cros Device

    7. Removing the CROS device Pull on the bend of the tube and remove the CROS device from behind the ear.

  • Page 18: Multi-Function Button

    8. Multi-function button The multi-function button has several functions. It functions as a volume control in the absence of wireless transmission of sound from the CROS device to the hearing aid, a balance control when there is a wireless transmission of sound from the CROS device to the hearing aid and/or a program change depending on the CROS device...

  • Page 19: Connectivity Overview

    9. Connectivity overview The illustration below shows the connectivity options available for your CROS system. Bluetooth® enabled device, e.g. cell phone TV Connector connected to TV* Roger** 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.

  • Page 20: Initial Pairing

    10. Initial pairing 10.1 Initial pairing to 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 CROS system will connect automatically to the device. The initial pairing process can take up to 2 minutes.
  • Page 21 Select the hearing aid from the list to pair the CROS system with the device. A beep confirms successful pairing. For more information about pairing instructions for Bluetooth wireless technology, specific to some of the most popular phone manufacturers, go to: https://www.phonak.com/com/en/support.html...
  • Page 22 10.2 Connecting to the device After your CROS system has been paired to your device, it will automatically connect again when switched on. The connection will be maintained as long as the device remains ON and within range. Your CROS system can be connected to one device at a time and paired to up to eight devices.

  • Page 23: Phone Calls

    11. Phone calls Your CROS system connects directly with Bluetooth enabled phones. When paired and connected to your phone, you will hear the caller’s voice directly in your hearing aid. Your voice is picked up by the hearing aid microphones and transmitted to the phone. Your voice Caller’s voice...
  • Page 24 11.1 Making a call Enter the phone number and press the dial button. You will hear the dialing tone through your hearing aid. Your voice is picked up by the hearing aid microphones and transmitted to the phone. 11.2 Accepting a call When receiving a call, a calling notification will be heard in the hearing aid.
  • Page 25 11.3 Ending a call A call can be ended by a long press on the upper or lower part of the multi-function button on the hearing aid or CROS device (more than 2 seconds) or directly on your phone. long press >...
  • Page 26 11.4 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 or CROS device (more than 2 seconds) or directly on your phone. long press >...

  • Page 27: Flight Mode

    12. Flight mode Your CROS system operates in the 2.4 GHz–2.48 GHz frequency range. When flying some operators require all devices to be switched into flight mode. Entering flight mode will not disable normal hearing aid functionality, and will only disable the Bluetooth connectivity functions including the wireless transmission of sound from the CROS device to the hearing aid on the other ear.
  • Page 28 12.2 Exit flight mode To enable the wireless function and exit flight mode in each device: Open battery door. Close the battery door on the CROS device again.

  • Page 29: Operating, Transport And Storage Conditions

    13. 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 this user guide. Please ensure to use, transport and store the CROS device according to the following conditions: Transport Storage +5°...

  • Page 30: Care And Maintenance

    14. Care and maintenance Diligent and routine care of your CROS device contributes to outstanding performance and a long service life. To ensure a long service life, Sonova AG provides a minimum of a five year service period after phase out of the respective CROS device.
  • Page 31 Your CROS device is resistant to water, sweat and dust under the following conditions: • The battery door is fully closed. Ensure that no foreign object such as hair is caught in the battery door when it is closed. • After exposure to water, sweat or dust, the CROS device is cleaned and dried.
  • Page 32 Daily Inspect the earpiece for earwax and moisture deposits 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 CROS device intensively, ask your hearing care professional for advice and information on filters or drying capsules.

  • Page 33: Exchanging The Earpice From The Tube

    15. Exchanging the earpiece from the tube 15.1 Removing the earpiece from the tube Remove the earpiece from the speaker dummy by holding the tube in one hand and the earpiece in the other. Gently pull off the earpiece to remove. Clean the speaker dummy with a lint-free cloth.
  • Page 34 15.2 Attaching the earpiece to the tube Hold the speaker dummy in one hand and the earpiece in the other. Slide the earpiece over the tube. The speaker dummy and the earpiece should fit perfectly together.

  • Page 35: Service And Warranty

    16. Service and warranty Local warranty Please ask the hearing care professional, where you purchased your CROS device, about the terms of the local warranty. International warranty Sonova AG offers a one year limited international warranty, valid starting from the date of purchase. This limited warranty covers manufacturing and material defects in the CROS device itself, but not accessories such as batteries, tubes, earpieces,...
  • Page 36 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 office.

  • Page 37: Compliance Information

    Regulation (EU) 2017/745 as well as the Radio Equipment Directive 2014/53/EU. The full text of the EU Declaration of Conformity can be obtained from the manufacturer or the local Phonak representative whose address can be taken from the list on www.phonak.com/us/en/ certificates (Phonak worldwide locations). Australia/New Zealand: Indicates a device’s compliance with applicable...
  • Page 38 The CROS model listed on page 2 is certified under: Phonak CROS P-13 FCC ID: KWC-MZP Canada IC: 2262A-MZP Notice 1: This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to...
  • Page 39 Notice 2: Changes or modifications 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 40 • Reorient or relocate the receiving antenna. • Increase the separation between the device and receiver. • Connect the device into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help.
  • Page 41 Radio information of your wireless CROS device Antenna type Resonant loop antenna Operation frequency 2.4 GHz – 2.48 GHz Modulation GFSK, GMSK Radiated power < 2.5 mW Bluetooth Range ~1 m Bluetooth 4.2 LE Dual-Mode Profiles supported HFP (Hands-free profile), A2DP...
  • Page 42 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 43 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 44: Information And Description Of Symbols

    18. Information and description of symbols With the CE symbol, Sonova AG confirms that this product – including accessories – meets the requirements of the Medical Devices Regulation 2017/745 as well as the Radio Equipment Directive 2014/53/EU. The numbers after the CE symbol correspond to the code of certified institutions that were consulted under the above-mentioned regulation and directive.
  • Page 45 Indicates the date when the medical device was manufactured Indicates the Authorized representative in the European Community. The EC REP is also the importer to the European Union. This symbol indicates that it is important for the user to read and take into account the relevant information in these user guides.
  • Page 46 This symbol confers that the electromagnetic interference from the device is under limits approved by the US Federal Communications Commission. Indicates a device’s compliance with applicable Radio Spectrum Management’s (RSM) and Australian Communications and Media Authority (ACMA) regulatory arrangements for the legal sale in New Zealand and Australia The Bluetooth®...
  • Page 47 The Compliance Identification Mark indicates that the device is in accordance with Brazilian conformity assessment requirements for equipment under health surveillance system. OCP indicates the certification body. Japanese mark for certified radio equipment. Indicates the manufacturer’s serial number so that a specific medical device can be identified.
  • Page 48 This symbol indicates that it is important for the user to read and take into account the relevant information in this user guide. 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...
  • Page 49 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 CROS device as well as the charger may not be thrown away as normal household waste.

  • Page 50: Troubleshooting

    Speaker/earpiece of hearing aid blocked Battery not inserted correctly CROS device or hearing aid switched off Phone call function does not work CROS system is in flight mode CROS system not paired to the phone Please check https://www.phonak.com/com/en/support.html for further information.
  • Page 51 What to do Change battery (chapter 5) Clean speaker opening/earpiece of hearing aid Insert battery correctly (chapter 5) Switch CROS device on by completely closing battery door (chapter 4) Open and close battery door (chapter 12.2) Pair it to the phone (chapter 10) If the problem persists, contact you hearing care professional for assistance.

  • Page 52: Important Safety Information

    20. Important safety information Please read the information on the following pages before using your CROS device. Intended use The Phonak CROS device is placed on the unaidable ear and wirelessly transmits sound to the Phonak hearing aid on the other ear. Indications The device is indicated for unaidable hearing loss in one ear and better hearing in the other ear.
  • Page 53 The primary criteria for the referral of a patient for a medical or other specialist opinion and / or treatment are as follows: • History of active drainage from the ear in the previous 90 days • History of sudden or rapidly progressive hearing loss in one or both ears within the previous 90 days •...
  • Page 54 The hearing care professional may decide that referral is not appropriate or in the best interest of the patient when the following applies: • There is sufficient evidence that the condition has been fully investigated by a medical specialist and the possible treatment has been provided •...
  • Page 55 If legally required, the patient must sign a disclaimer to confirm their rejection of the referral advice and that they made an informed decision. A CROS device will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions.
  • Page 56 Intended patient population: This device is intended for patients with unaidable hearing loss in one ear and better hearing in the other ear, from 36 months of age. Intended user Intended for people with unaidable hearing loss in one ear and better hearing in the other ear, using the CROS device and their caregivers.
  • Page 57 Side effects Wearing your CROS device may result in undesirable physiological side effects or adverse reactions, which all may result from the shape and material of the housing and the earpiece, such as: • Build-up of ear wax, • Too much pressure, •...
  • Page 58 Any serious incident that has occurred in relation to the CROS device, should be reported to the manufacturer representative and the competent authority of the state of residence. A 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 59 20.1 Hazard warnings Your CROS device operates between 2.4 GHz–2.48 GHz frequency range. When flying please check if flight operator requires devices to be switched into flight mode, see chapter 12. Changes or modifications to the CROS device that were not explicitly approved by Sonova AG are not permitted.
  • Page 60 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. In very rare cases, the dome can remain in your ear canal when removing the hearing tube from the ear.
  • Page 61 This CROS device 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 CROS device is a small device and contains small parts.
  • Page 62 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. 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 CROS devices, including cables specified by the manufacturer.
  • Page 63 Avoid strong physical impacts to the ear when wearing the CROS device with customized earpiece. The stability of customized earpieces is designed for normal use. A strong physical impact to the ear (e.g. during sports) may cause the customized earpiece to break. This may lead to perforation of the ear canal or eardrum.
  • Page 64 20.2 Information on product safety The CROS device is water resistant and not waterproof. It is designed to withstand normal activities and occasional accidental exposure to extreme conditions. Never immerse your hearing aid in water! It is not specifically designed for extended periods of water submersion on a continual basis, that is worn in activities such as swimming or bathing.
  • Page 65 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. When you are not using your CROS device, leave the battery door open so that any moisture can evaporate.
  • Page 66 The batteries used in these CROS device should not exceed 1.5 Volts. Please do not use silver-zinc or Li-ion (lithium-ion) rechargeable batteries as these may cause severe damage to your CROS device. The table in chapter 5 explains exactly which type of battery your particular CROS device require. Remove the battery if you are not using your CROS device for a long period of time.

  • Page 67: For The Us Market Only, Complies With The Fda Regulations

    21. For the US market only, complies with the FDA regulations Important information: Cell phones Some hearing aid users have reported a buzzing sound in their hearing aids when they are using cell phones. According to the ANSI 63.19 (American National Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Instruments) standard, the compatibility of a particular hearing aid and...
  • Page 68 Note: the performance of individual hearing aids may vary with individual cell phones. Therefore, please try the hearing aid with your cell phone or, if you are purchasing a new phone, be sure to try it with your hearing aid prior to purchase. For additional guidance, please ask your hearing care professional for the booklet entitled “hearing aid compatibility with digital wireless cell phones”.
  • Page 69 Warning to hearing aid dispensers A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions:...
  • Page 70 (v) Unilateral hearing loss of sudden or recent onset within the previous 90 days. (vi) Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz. (vii) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
  • Page 71 Important notice for prospective hearing aid users Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists.
  • Page 72 The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable the audiologist or dispenser to select and fit a hearing aid 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 program.
  • Page 73 consultation with a physician. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged. Children with hearing loss In addition to seeing a physician for a 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 the educational and social growth of a child.
  • Page 74 program to provide temporary relief from tinnitus. It should always be used as prescribed by your audiologist. The underlying principle of sound enrichment is to provide supplementary noise stimulation which can help defocus your attention from your tinnitus and avoid negative reactions.
  • Page 75 The noise generator should never be used at uncomfortable levels. For more information visit www.phonak.com...
  • Page 76 Your hearing care professional: Australian Sponsor: Sonova Deutschland GmbH Sonova Australia Pty Ltd Max-Eyth-Strasse 20 Locked Bag 5006 Norwest, 70736 Fellbach-Oeffingen NSW, 2153 Germany Australia Manufacturer: Sonova AG Laubisrütistrasse 28 CH-8712 Stäfa Switzerland www.phonak.com...

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Cros p-13

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