USER GUIDE |.Air Conduction Hearing Aid Structure composition This product consists of microphones, signal processing circuits, speakers, batteries, shells, earplugs and charging accessories. Working principle The input transducer converts the input sound energy into electrical energy and transmits it to the signal conditioning unit. After the signal conditioning unit performs A/D conversion of the input signal, it uses a digital signal processor to perform a series of processing, amplify, and transmit it to the output transducer. The output transducer transmits the processed signal to the ear canal through the earplug through the air conduction method.Scope of application For people with air conduction hearing loss Product performance Product performance 1. Appearance and structure 1.1 All parts should be fully assembled and fixed reliably 1.2 The text, symbols or marks should be clear, correct and firm 1.3 The surface should be free of defects such as burrs, flashes, dents, scratches, etc. 1.4 The connection of each component should be reliable and effective 1.5 The operation of various adjustment buttons, switches and other mechanisms should be flexible and effective 2. Electromagnetic compatibility 02a) It shall meet the requirements of the neigh— bour compatibility regulations in GB/T25102.13-2010 ”Electroacoustics, Hearing Aids No. 13: Electromagnetic Compatibility (EMC)” b) Should meet the requirements specified in YY0505-—2012 ”Medical Electrical Equipment Part 1-2: General Safety Requirements Parallel Standard: Electromagnetic Compatibility Requirements and Tests” 3. Environmental test requirements The environmental test of hearing aids should meet the requirements of 4.4 and Table 2.1 and 2.2 of GB/T14199-2010. The transportation test should meet the requirements of Chapter 4 in GB/T14710-2009. 4. Safety requirements Should comply with the provisions of GB/9706.1-2007 ”Medical Electrical Equipment Part 1: General Requirements for Safety” 03Contraindications 1) Congenital atresia of the external ear or malformation of the external auditory canal, a large number of foreign bodies in the external auditory canal; 2) Unstable deafness condition, and the degree of hearing loss often fluctuates; 3) The chief complaint is accompanied by obvious symptoms such as headache, dizziness, earache, tinnitus, etc.; 4) Sudden deafness in the past 3 months; progressive rapid deafness; obvious unilateral deafness or other acute ear diseases at the same time; 5) Middle ear effusion and frequent discharge of pus; 6) Central deafness; non-organic deafness; 7) Patients with acute otitis externa and tympa- nicitis; 8) Suitable for the crowd: over 18 years old 049) Chronic suppurative otitis media (in the period of pus infection); 10) Acute suppurative otitis media is not suitable for wearing air conduction hearing aids; 11) Patients who are allergic to the materials of this product. Precautions 1. Read the instruction manual carefully and completely before use. 2. Professional examination and hearing test should be conducted before fitting the hearing aid, and use it under the guidance of a doctor or a professional fitter of hearing aid. 3. Pay attention to the product’s moisture—proof, shock-proof and high-temperature protection. 4. Do not immerse the hearing aid in any liquid. Remove the hearing aid before swimming and washing your hair and taking a shower; after swimming or washing, wait until the ear canal is 05dry before putting on the hearing aid. 5. After you take off your hearing aid at night, you should put it in a desiccant box and avoid light, high temperature and high humidity, and also avoid falling and touching.. 6. The outer surface of the hearing aid should be kept clean, and the earwax in the earplugs should be cleaned frequently. 7. The function and volume control switch should be used correctly, try to turn on and off lightly to avoid excessive force or excessive force. 8. Hearing aids should be sent to the fitting center for maintenance and inspection on a regular basis to ensure that the hearing aids are in good condition. 9. Avoid putting it together with a strong magnetic field, otherwise it will affect the sensitivity of the hearing aid. 0610. If you feel uncomfortable with your ears during use, replace suitable earplugs or consult a physician. 11. Please use the original battery. Please contact the manufacturer or designated after-sales service for product maintenance. 12. Instructions for safe use and maintenance of rechargeable batteries a) When charging the hearing aid, it should be charged through a professionally equipped power adapter or a computer USB port b) Hearing aid charging: first turn off the power of the hearing aid, and then charge it. The first charge should ensure sufficient charging time (not affected by the indicator light), and a charging time of 5-6 hours should be guaranteed c) If the hearing aid is not used for a long time, the battery self-discharge will cause the battery to be seriously insufficient. It should be charged, and the charging time should reach 5-6 hours. 07Even if the charging indicator shows that the charging is complete, the charging should not be stopped (guarantee to reach 5-6 hours ) Installation and usage instructions *See the operating guide for details Fault self—check When there is a problem with your hearing aid in use, please refer to the method in the table below for simple handling: Failure Possible Approach phenomenon Causes 1. Low battery 1. Replace 2. The volume knob is battery/charge Murmur worn 2. Send in for repair 3. Poor contact between | 3. Send in for repair battery and battery springFault self-check When there is a problem with your hearing aid in use, please refer to the method in the table below for simple handling: Failure Possible Approach phenomenon Causes 1. Excessive earwax in 1. Clean the ear the ear canal canal 2. The position of the 2. Take out and eardrum head is not re-wear correct 3. Turn down the 3. The volume is too volume or Howl high reprogram 4. The eardrum is not 4. Change the sealed eardrum 5. The catheter or 5. Replace with a hearing aid ear hook is new sound guide aging or damaged tube or ear hook 1. The battery is dead 1. Replace 2. The sound hole is battery/charge blocked 2. Clean the sound No sound 3. The switch is broken hole 4. Poor contact between | 3. Send in for battery and battery repair spring 4. Send in for repair 09Maintenance Hearing aids are sophisticated and sensitive electronic devicesthat require regular cleaning. Cleaning ear wax, ear flakes and proper maintenance will ensure the longevity and reliability of your hearing aid. Wipe with a dry cotton cloth or a soft cloth, not with any solvents or cleaners. Use a soft dry cloth and tissue to wipe off grease and moisture from the hearing aid housing. If the hearing aid is in a humid environment or is often in contact with sweat, please open the hearing aid battery compartment door when not wearing it at night and place it in a drying box containing a desiccant. For details, please refer to the drying box for the use of desiccant. When the hearing aids with zinc—air batteries are not in use, please open the battery compartment to prevent the machine from continuing to work and reduce the life of the machine, as well as to save battery power. 10Hearing aids should be kept out of the reach of children, to prevent children from playing or swallowing them as toys, which causing unnecessary losses and risk. The product is an electronic product. Please place it in a dry place. Wipe the contacts before each charge to reduce equipment failure. It is necessary to ensure that the hearing aid is removed when sleeping, bathing, and swimming to prevent the hearing aid from getting wet. Do not wash the hearing aid by water or other liquids to avoid damage to the hearing aid circuit. Clean the microphone port In order to ensure the performance of the hearing aid, please keep the microphone sound input port clean, and gently brush off the dirt on the input port with the soft brush provided with the hearing aid. 11Storage/transportation conditions and methods 1) Normal use environmental conditions a) Ambient temperature: -10°C~ 40°; b) Relative humidity: <80%; c) Atmospheric pressure: 86kPa~ 106kPa; 2) The product should be stored in a room with no corrosive gas and well ventilated, and the environment should meet the following condi- tions: a) Ambient temperature: -40°C~55°; b) Relative humidity: <93%; c) Atmospheric pressure: 50kPa~ 150kPa; 3) Handle with care to avoid collision or strong impact on the product. Disposal of waste and residue Do not throw away scrapped batteries, main-— frames and accessories at will. The disposal of wastes and residues should comply with the corresponding national laws and regulations. 12Parts List See packaging for details Graphic symbol explanation Note, refer to the attached file El Manufacturer e@ |8-type roa application part t t up equipment uw LOT] | Production batch Prevent rain Period of use as we = — = Protect against sun ~S -@ ZI\ Separate disposal mark for waste electri- cal and electronic equipment (please comply with loca laws and regulations) 13Hearing aid electrical classification Electric shock type classification: internal power supply Classification of electric shock degree: Type B Anti-liquid protection degree: ordinary equipment The device is not AP type or APG type Equipment operation mode: continuous operation Electromagnetic Compatibility L\ Note: e This Air Conduction digital hearing aid complies with the electromagnetic compatibility require— ments of YY 0505 and GB/T 25102.13 stan- dards. e The user should install and use it according to the electromagnetic compatibility information provided by the accompanying documents. © Portable and mobile RF communication equip— ment may affect the performance of the Air Conduction hearing aid. Avoid strong electro— magnetic interference when using it, such as close to mobile phones, microwave ovens, etc. 14e Please refer to the attachment for the guide— lines and manufacturer’s declaration. LN Warning: e The Air Conduction hearing aid should not be used close to or stacked with other equip— ment. If it must be used close or stacked, it should be observed and verified that it can operate e mormally under the configuration used. Except for the cables sold by the manufactur— ers of the Air Conduction hearing aids as spare parts of internal components, the use of accessories and cables other than those specified may result in an increase in the emission of the Air Conduction hearing aids or a decrease in immunity. Should meet the requirements specified in GB/T 25102.13-2010. 15The field strength of the radio frequency test signal when the Air Conduction Hearing Aid complies with the immunity of the hearing aid specified in GB/T 25102.13 Neighbor Compatibility IRIL<55dB when in the following field strength Field strength expressed in V/m Frequency range GHz 0.08~0.8 | 0.8~0.96 | 0.96~1.4 | 1.4~2.0 2.0~3.0 Microphone mode / 3 / 2 / Annex: Guidelines and manufacturer’s declaration—electromagnetic emissions This Air Conduction Hearing Aid is expected to be used in the following electromagnetic environment, and the purchaser or user should ensure that it is used in this electromagnetic environment: Launch test | Compliance Electromagnetic environment-guide GB4824 team 1 This Air Conduction Hearing Aid uses RF launch RF energy only for its internal function. Therefore, its RF emission is very low and may not cause any interference to nearby electronic equipment. 16GB4824 Type B ; A RF launch ye The Air Conduction Hearing Aid is suitable for use in the home and all Gb17625.1 Not applicable facilities directly Harmonic emission connected to the residential public low-voltage power supply GB17625.2 Not applicable | network for the home. Voltage fluctuation flicker emission Guidelines and manufacturer’s declaration—electromagnetic immunity This Air Conduction Hearing Aid is expected to be used in the following electromagnetic environment, and the purchaser or user should ensure that it is used in this electromagnetic environment: Immunity IEC60601 Coincidence Electromagnetic testlmmunity test | test level level environment—guide The floor should be wood, concrete or +6 kV +6 kV ceramic tiles. If the Electrostatic contact contact floor is covered discharge (ESD) discharge discharge with synthetic GB/T 17626.2 +8 KV air +8 kV air material, the discharge discharge relative humidity should be at least 30%. 17Electrical fast +2kV to power cord transient burst TKV t Not Not ransient burst + ‘0 ‘ ‘ applicabl applicabl GB/T 17626.4 input/output pplicable pplicable line +1 kV differential surge mode voltage Not Not GB/T 17626.5 +2 kV applicable applicable common mode voltage <5% UT for 0.5 weeks Voltage sag, (On UT, >95% short-term dip) interruption and | 40% UT for 5 voltage change | Weeks Not Not op ai on the power (On UT, 60% dip) | a nticable applicable input line GB/T 17626.11 70% UT for 25 weeks (On UT, 30% dip) <5% UT for 5s (On UT, >95% dip) 18The power frequency magnetic field should have the level characteristics 3A/m of the power 3A/m 50/60Hz frequency magnetic field in a typical place in a typical commercial or hospital environment. Power frequency magnetic field (50/60Hz) GB/T 17626.8 Note: UT refers to the AC network voltage before the test voltage is applied *Due to the continuous upgrading and updating of products, design specifications are subject to change without notice; all information has been carefully checked. If there are any printing errors or omissions, the company will not bear the conse— quences. Compilation date: 2020.07.10 Revision Date: 2021.06.10 The picture is for reference only, please refer to the actual product 19warranty ca Product number____________ Production batch. Sales record Product Serial Number. Purchase date Dealer Username Contact number Contact address Note: The sales unit should fill in the above content carefully and hand it to the user to save. Each time the free warranty is given, this card and purchase invoice must be presented Maintenance records Repair date | Fault and inspection | Repair date Repairman record 20warranty ca Thank you for choosing our company’s hearing aids. From the date of purchase of this product, there is a free warranty if the product has quality problems under normal trial use within one year. Please keep this card properly Warranty 1. This product is guaranteed for one year. During the warranty period, if the product is of poor quality or manufacturing failure, it can be maintained 2. Cost material fees and service fees will be charged as appropriate when encountering the following situations. a. Failure and damage caused by improper use b. Failure or damage caused by unauthorized disassembly and assembly without the authorization of the company c. Exceeding the warranty period 3. Warranty with the warranty card 21Made in China 22ificate of co avi avg product name ____Air Conduction Hearing Aid __ Period of use __Three years (one year battery warranty) _ Product number Inspection date Production batch Inspectors The product has been inspected and complies with the national FDA standard, and the product has passed the inspection and is allowed to leave the factory. --& ------------ - ee e- err er err ere Ke