background image

45

 

Emissions

CISPR 11, Class B.

Immunity

ESD, Conducted up to +/-8 kV, 

 

Air discharge up to +/-15 kV

Power frequency magnetic fields: 

 

30 A/m, 50/60 Hz

Immunity 

 

to RF fields

80 MHz-2.7 GHz 10 V/m, 

 

2.7 GHz-6 GHz 3 V/m

Proximity to wireless 

communication 

devices

Up to 28 V/m – 

 

See IEC 60601-1-2:2014/AMD1:2020, 

 

Table 9

Proximity to 

magnetic fields

8 A/m@30 kHz, 65 A/m@134.2 kHz, 

7.5 A/m@50 kHz 

Summary of Contents for CRE-C10

Page 1: ... Safety and maintenance information Self fitting hearing aid CRE C10 ...

Page 2: ... What to do in loud environments 8 Click Sleeves 10 Adjusting your hearing aid 12 Batteries 14 Damaged devices unauthorized changes 16 Explosive atmospheres 17 Exposure to Nickel 18 Choking hazard 19 Restricted areas for wireless devices 20 Interference by strong radiation 21 ...

Page 3: ... information 28 Operating transport and storage conditions 28 Conformance information 30 Regulatory information 34 For hearing aid users 35 Quality of Service QoS for the ear to ear wireless technology 47 Cybersecurity 49 For children with hearing loss 50 Support 51 ...

Page 4: ...ed to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment It is adjusted by the user to meet the user s hearing needs through software tools The device is intended for direct to consumer sale and use without the assistance of a hearing care professional The Sony Hearing Control app is intended to support self fitting and fine tuning of the hear...

Page 5: ...currently experience any of these conditions as it may not be appropriate for you X severe hearing loss or deafness in at least one ear X a steep decline in hearing ability within the last 90 days in one or both ears X active discharge within the last 90 days X dizziness X a visible deformity of the ear X pain or discomfort in the ear X significant ear wax accumulation ...

Page 6: ...this device is appropriate for you consult a licensed physician before using this device WARNING This hearing aid is intended for you only and should not be worn by others NOTICE Do not use your hearing aids while swimming or while taking a shower ...

Page 7: ...ring aid If an allergic reaction develops after wearing the hearing aid immediately discontinue use and consult a licensed physician WARNING Contact your physician if you experience any unusual skin irritation excessive accumulation of ear wax dizziness change in your hearing or if you think there might be an object in your ear canal ...

Page 8: ...nvironments WARNING Do not use this device as hearing protection in loud environments WARNING Remove hearing aids before using hearing protection equipment Noise cancelling headphones should not be used as hearing protection ...

Page 9: ...ing Keep the loudness at comfortable listening levels Wear hearing protection when exposed to loud environmental noise NOTICE The smartphone generates short tone sequences to control the hearing aids Do not hold the smartphone close to the ear while using the app ...

Page 10: ... attached You should feel that it snaps into place X Ensure that only a single Click Sleeve is attached to each hearing aid X In the very rare case that the Click Sleeve gets stuck in the ear canal and you cannot remove it yourself please contact a physician X Do not insert the Click Sleeves in your ear without the hearing aid attached ...

Page 11: ...ntended position making sure there is no discomfort resistance NOTICE Select the Click Sleeve size that gives you the best wearing comfort in each ear Left and right ear sizes may differ Choose a larger size in case of whistling problems ...

Page 12: ...street or driving a car WARNING Your hearing devices may reduce certain background sounds potentially also traffic or warning signals Adjust the hearing aid to ensure you can hear surrounding sounds including alarms and warning signals Be aware that it may be more difficult to identify where a sound is coming from during the first few weeks of use ...

Page 13: ...13 NOTICE Set up the hearing aids in a quiet environment without interruptions for the best result ...

Page 14: ...eries NOTICE Leaking batteries damage the hearing aids X Turn the hearing aids off when not in use to preserve the battery X Remove batteries when the hearing aids are not in use for a prolonged period of time ...

Page 15: ...for your hearing aid Battery size IEC code ANSI code Typical color code 10 PR70 7005ZD yellow NOTICE X To avoid environmental pollution do not throw batteries or hearing aids into household trash X Recycle or dispose of batteries or hearing aids according to local regulation ...

Page 16: ...X Do not use damaged devices Please consult the customer service WARNING Note that any unauthorized changes to the device may cause damage to the device or cause injury X Use only approved parts and accessories Contact the customer service for suitable accessories ...

Page 17: ...17 Explosive atmospheres WARNING Risk of explosion X Do not use your hearing aids in explosive atmospheres e g mining areas ...

Page 18: ...18 Exposure to Nickel WARNING This product can expose you to nickel which is known to the State of California to cause cancer For more information go to www P65Warnings ca gov ...

Page 19: ...hoking hazard Your hearing aids contain small parts which can be swallowed X Keep hearing aids batteries and accessories out of reach of children and pets X If parts have been swallowed consult a physician or hospital immediately ...

Page 20: ...20 Restricted areas for wireless devices WARNING Switch off the hearing aid in areas where the use of wireless devices is restricted ...

Page 21: ... g during X ray or MRI head examinations may damage hearing aids X Do not wear the hearing aids during these or similar procedures like electrosurgery diathermy electrocautery HF surgery Weaker radiation e g from radio equipment or airport security does not damage the hearing aids ...

Page 22: ...ence free for example some induction cookers electromagnetic security systems e g anti theft systems and metal detectors cellular telephones RFID room surveillance systems may cause audible interference If you encounter unwanted noise in the vicinity of such device you should increase the distance between the hearing aid and that device ...

Page 23: ...y NOTICE X Clean your hearing aids daily with a soft and dry tissue Never use water Only use cleaning products declared for use with hearing aids NOTICE X Protect your hearing aids from high humidity Do not wear them in the shower or when you apply make up perfume aftershave hairspray or suntan lotion ...

Page 24: ...24 NOTICE X Protect your hearing aids from extreme heat Do not store them in direct sunlight NOTICE X Do not dry your hearing aids in the microwave oven ...

Page 25: ...25 Explanation of symbols Symbols used in this document Points out a situation that could lead to serious moderate or minor injuries Indicates possible property damage ...

Page 26: ...the device with general domestic waste Read more in section Disposal information Read and follow the instructions in the user guide According to IEC 60601 1 the applied parts of this device are classified as type B Keep dry during transportation and storage ...

Page 27: ...Operating transport and storage conditions Relative humidity during transportation and storage Read more in section Operating transport and storage conditions Atmospheric pressure during transportation and storage Read more in section Operating transport and storage conditions Keep out of reach of children ...

Page 28: ...aring aids is 5 years Operating transport and storage conditions The hearing instruments operate in the following environmental conditions also valid in between uses Temperature 0 to 50 C 32 to 122 F Relative humidity 5 to 93 Atmospheric pressure 700 to 1060 hPa ...

Page 29: ...e observe the following conditions Storage Transport Temperature 10 to 40 C 50 to 104 F 20 to 60 C 4 to 140 F Relative humidity 10 to 80 5 to 90 Atmospheric pressure 700 to 1060 hPa 700 to 1060 hPa For other parts such as batteries other conditions may apply ...

Page 30: ...FCC regarding electromagnetic interference Notices Changes or modifications made to this equipment not expressly approved by the legal manufacturer may void the FCC authorization to operate this equipment This device complies with Part 15 of the FCC Rules and with ISED s licence exempt RSSs ...

Page 31: ...ly with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However...

Page 32: ... 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 separation between the equipment and receiver Connect the equipment to 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 33: ...vice has been tested and meets the FCC RF exposure guidelines when used with the legal manufacturer s accessories supplied or designated for this product Use of other accessories may not ensure compliance with FCC RF exposure guidelines ...

Page 34: ... aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology including software that allows users to program their hearing aids This technology integrates user input with a self fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings ...

Page 35: ...hearing impairment resulting from organic conditions In most cases infrequent use of hearing aids prohibits the wearer from attaining the full benefit from it The use of hearing aids is only part of hearing rehabilitation and may need to be supplemented by auditory training and instruction in lip reading ...

Page 36: ...ek medical attention immediately or call the National Button Battery Ingestion Hotline collect at 1 800 498 8666 Identification information Your hearing aids have a serial number imprinted on them The location of the serial number will vary according to the style of hearing aid you have chosen Record the serial number in your user guide for future reference ...

Page 37: ...e is incorporated into the serial number For in the ear devices the year of manufacture is derived from the first two digits The month of manufacture is derived from the first digit the year of manufacture from the second digit ...

Page 38: ...t digit Month Code first digit Month A N Jan G U Jul B P Feb H V Aug C Q Mar J W Sep D R Apr K X Oct E S May L Y Nov F T Jun M Z Dec Code second digit Year Code second digit Year B C 2022 F G 2024 D E 2023 H J 2025 ...

Page 39: ...of the wireless technology Wireless technology Nearfield magnetic induction Antenna type Inductive antenna Antenna dimensions Ø 3 3 mm L 4 2 mm respectively Ø 2 0 mm L 6 7 mm Modulation PSK Phase Shift Key Magnetic field strength 0 07 A m 1 cm2 coil average Output power EIRP 53 μW ...

Page 40: ...ter frequency 3 28 MHz Channel Single channel radio Bandwidth 138 kHz Data rate 324 kbit sec raw channel capacity Data flow Simplex or semi duplex capability Protocol Random access no collision avoidance S A R 6 63 nW kg S A R Specific Absorption Rate S A R based on 10 g ICNIRP testing ...

Page 41: ... EMC EMI standards Standard Test Type Note 47 CFR Part 15 Subpart C RF emissions U S FCC requirements for intentional radiators EN 300 330 RF emissions including spurious emission EMC and radio spectrum matters for short range devices in the frequency range 9 kHz 25 MHz ...

Page 42: ...3 17 Immunity RF and ESD Standard for low power transmitters in the frequency range 9 kHz 40 GHz IEC 60118 13 RF immunity International product standard for hearing aids to ensure adequate immunity to radio interference from mobile telephones ...

Page 43: ...63 19 RF immunity American National Standard method of measurement of compatibility between wireless communication devices and hearing aids ANSI AAMI PC69 RF emissions Implantable medical device EMC immunity American National Standard ...

Page 44: ...44 Standard Test Type Note ISO 14117 RF emissions Implantable medical device EMC immunity International Standard EN 45502 2 1 RF emissions Particular requirements for pacemakers ...

Page 45: ... kV Power frequency magnetic fields 30 A m 50 60 Hz Immunity to RF fields 80 MHz 2 7 GHz 10 V m 2 7 GHz 6 GHz 3 V m Proximity to wireless communication devices Up to 28 V m See IEC 60601 1 2 2014 AMD1 2020 Table 9 Proximity to magnetic fields 8 A m 30 kHz 65 A m 134 2 kHz 7 5 A m 50 kHz ...

Page 46: ...that includes A built in pairing table which specifies valid and legitimate pairing among units A proprietary communication protocol which checks the package numbers during each transmission A Cyclic Redundancy Check CRC to check data validity A convolutional encoder decoder Viterbi to correct errors ...

Page 47: ...s Similar QoS as with remote controls in typical households In typical environment it can happen that electromagnetic noise from appliances light switch car ignition lead to non valid data Transmission of unsuccessful command is automatically repeated within approximately 3 seconds Data transfer is checked via CRC16 checksum ...

Page 48: ...stimated and monitored during data receive For BER 3 5 the channel coding will become less effective thus the transferred microphone signal is automatically muted and not used until the QoS is good enough again For the used ITU G 722 Audio Codec CRC check is not useful It is reasonably foreseeable that no risk hazard can rise caused by invalid data ...

Page 49: ...requires a safe private and secure operating environment The U S Federal Trade Commission s guidance for online security https consumer ftc gov online security provides examples of best practices for securing your home network and mobile device to ensure your security ...

Page 50: ...oss 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 An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss ...

Page 51: ...51 Support For more detailed information or in case of unexpected events Visit our website sony net hearing support Phone 877 864 7669 ...

Page 52: ...Document No 05195 99T02 7600 EN Order Item No 210 224 47 Master Rev02 08 2022 Printed in Singapore Manufactured for Sony Electronics Inc 115 West Century Road Suite 250 Paramus NJ US 07652 ...

Reviews: