OTC JH-D26AT Rechargeable BTE Hearing Aid Instruction Manual

JH-D26AT Rechargeable BTE Hearing Aid
Instruction Manual

JH-D26AT Rechargeable BTE Hearing Aid

Please read this user manual thoroughly and completely before using the product.
WARNINGS

1. WARNING:If you are younger than 18,do not use this.
   You should go to a doctor, preferably an ear-nose-throat doctor(an ENT), because your condition needs specialized care. Over-thecounter hearing aids are only for users who are age 18 or older.
   This OTC hearing aid is for users who are 18 and older.
   People who are younger than 18 with hearing loss should see a doctor, preferably an ENT, because they may need medical testing and management. Hearing loss can affect speech and learning, so professional fitting and continuing care are also important.

2. WARNING:When to see a doctor
   If you have any of the problems listed below, please see a doctor, preferably an ear-nose-throat doctor(an ENT).
   ● Your ear has a birth defect or an unusual shape. Your ear was injured or deformed in an accident
   ● You saw blood, pus, or fluid coming out of your ear in the past 6 months
   ● Your ear feels painful or uncomfortable
   ● You have a lot of ear wax, or you think something could be in your ear
   ● You get really dizzy or have a feeling of spinning or swaying(called vertigo)
   ● Your hearing changed suddenly in the past 6 months
   ● Your hearing changes: it gets worse then gets better again
   ● You have worse hearing in one ear
   ● You hear ringing or buzzing in only one ear

3. WARNING:This hearing aid should not cause pain when inserting it.
   Remove this device from your ear if it causes pain or discomfort when you insert or place it. To try again, make sure to follow the instructions. If you feel pain or discomfort again, contact the manufacturer. If your pain or discomfort doesn’ t go away, contact your hearing healthcare professional. You can also report this to FDA as an adverse event according to the instructions that appear later.

4. WARNING: do not use if any of the followings apply to you
   ● Congenital atresia of external ear or deformity of any part of the ear canal
   ● Deafness is unstable, and the degree of hearing loss often fluctuates
   ● Persistent headaches, dizziness, earaches, tinnitus or other symptoms that are not suitable for adaptation
   ● Sudden onset of hearing loss within the past 3 months; rapid progressive deafness; unilateral hearing loss or other acute ear disease
   ● Effusion (secretions/discharge) in the ear and/or frequent purulence (pus).
   ● Central deafness (central nervous system) or non-organic deafness.
   ● Patients with acute otitis externa and tympanitis.
   ● Patients with acute and chronic suppurative otitis media (in the period of purulent infection).
   ● Patients who are allergic to the materials of this product.

5. WARNING:important safety instruction
   ● Keep small parts(hearing instrument, eartips, battery or other detachable parts)that can be swallowed out of children’s reach.
   ● Dropping, immersing in liquid, exposure to strong electromagnetic fields or excessive heat will damage the hearing aid. Remove devices prior to any type of X-ray, MRI, or CT scan.
   ● If parts become stuck in the ear canal, seek medical assistance-do not attempt to remove by yourself.
   ● Do not use at high volume for extended periods of time – ear injury can result.
   ● If you experience any pain or strong discomfort using the devices, remove and consult a doctor.
   ● Routine maintenance to keep the device clean is required. Ensure that eartips are free of debris and moisture at all times.
   ● Do not store or use the product in environments of high humidity or temperature (such as sauna room), to avoid damage.
   ● Batteries should be properly recycled and not disposed in the trash.
   ● Keep the devices away from children. Injury or damage may result.
   ● Do not share your hearing aids with others. Using a hearing aid configured for someone else can result in hearing damage or injury.
   ● Monitor for any unusual skin reaction. If you notice any allergic reaction (itchiness, swelling, or rash), stop wearing the hearing aids and consult a medical specialist.
   ● Stay away from strong electromagnetic fields when using hearing aid to avoid unexpected damage. Your hearing aids are delicate electronic instruments and may be damaged by contact with strong magnetic equipment such as electromagnetic ovens, microwave ovens, ultrasonic cleaners, etc.
   ● If the Bluetooth function is available for your device,do NOT connect the hearing aid and headsets to the mobile phone via Bluetooth simultaneously – noise,distortion or any other unexpected problems may occur to your hearing aid.
   ● Please contact the MANUFACTURER:

For assistance, if needed, in setting up, using or maintaining your devices or to report any unexpected operation or events.

• Contact your hearing professional for assistance if needed.
• Do NOT fix your devices by yourself. Doing so will not only void the warranty but also cause further damage easily – Check the “7.1 Troubleshooting” first when failures occur to your devices.

CAUTIONS AND NOTICES

1. Caution: This is not hearing protection.
   You should remove this device if you experience overly loud sounds, whether short or long-lasting. If you’re in a loud place, you should use the right kind of hearing protection instead of wearing this device. In general, if you would use ear plugs in a loud place, you should remove this device and use ear plugs.

2. Caution: The sound output should not be uncomfortable or painful.
   You should turn down the volume or remove the device if the sound output is uncomfortably loud or painful. If you consistently need to turn the volume down, you may need to further adjust your device.

3. Caution: You might need medical help if a piece gets stuck in your ear.
   If any part of your hearing aid, like the eartip, gets stuck in your ear, and you can’t easily remove it with your fingers, get medical help as soon as you can. You should not try to use tweezers or cotton swabs because they can push the part farther into your ear, injuring your eardrum or ear canal, possibly seriously.

4. Note: If you remain concerned, consult a professional.
   If you try this device and continue to struggle with or remain concerned about your hearing, you should consult with a hearing healthcare professional.

5. Note: What you might expect when you start using a hearing aid
   A hearing aid can benefit many people with hearing loss. However, you should know it will not restore normal hearing, and you may still have some difficulty hearing over noise. Further, a hearing aid will not prevent or improve a medical condition that causes hearing loss.
   People who start using hearing aids sometimes need a few weeks to get used to them. Similarly, many people find that training or counseling can help them get more out of their devices.
   If you have hearing loss in both ears, you might get more out of using hearing aids in both, especially in situations that make you tired from listening—for example, noisy environments.

6. Note: Tell FDA about injuries, malfunctions, or other adverse events.
   To report a problem involving your hearing aid, you should submit information to FDA as soon as possible after the problem. FDA calls them “adverse events,” and they might include: skin irritation in your ear, injury from the device (like cuts or scratches, or burns from an overheated battery), pieces of the device getting stuck in your ear, suddenly worsening hearing loss from using the device, etc. Instructions for reporting are available at https://www.fda.gov/Safety/MedWatch, or call 1-800-FDA-1088. You can also download a form to mail to FDA.

7. Note:If you experience side effects, contact a hearing care professional.
   Possible side effects from wearing the hearing aid may be:
   – Dizziness
   – Tinnitus
   – Perceived worsening of hearing loss
   – Nausea
   – Headache
   – Skin reaction
   – Excessive ear wax accumulation

8. Note:Tips for better communication
   It will take practice, time, and patience for your brain to adapt to the new sounds that your hearing aids provide. Hearing is only part of how we share thoughts, ideas and feelings.
   Reading lips, facial expressions, and gestures can help the learning process and add to what amplification alone may miss.
   (1) Please review the following simple communication tips for you:
   ● Move closer to and look at the speaker.
   ● Sit face-to-face in a quiet room if possible.
   ● Try out different locations to find the optimal places to listen
   ● Minimize distractions.
   ● Background noises may be frustrating at first; remember, you have not heard them for a while.
   ● Let others know what you need; keep in mind that people cannot “see” your hearing loss.
   ● Develop realistic expectations of what your hearing aids can and cannot do.
   ● Better hearing with hearing aids are a learned skill combin- ing desire, practice, and patience.
   (2) You will learn and adjust, it just takes a little time. Remem ber to be patient with yourself.
   (3) For Your Family and Friends:
   Your family and friends are also affected by your hearing loss. Request that they:
   ● Get your full attention before beginning to speak.
   ● Look at you or sit face-to-face.
   ● Speak clearly and at a normal rate and level; shouting can actually make understanding more difficult.
   ● Rephrase rather than repeat the same words; different words may be easier to understand.
   ● Minimize distractions while speaking.

9. Additional cautions:
   ● The use of accessories and cables other than those specified by manufacturer, with the exception of cables sold by manufacturer as replacement parts for internal components, may result in increased emission or decreased immunity of the device.
   ● Do not use a mobile phone or other devices that emit electro magnetic fields, near the unit. This may result in incorrect operation of the unit.
   ● Do not bring the device into any MRI, CT, diathermy, RFID and electromagnetic security systems such as metal detectors environment or near any of this equipment. Consult manufacturer if you have any questions.
   ● This device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this device should be observed to verify normal operation in the configuration in which it will be used.
   ● Refer to further guidance below regarding the EMC environment in which the device should be used.
   There is no guarantee that interference will not occur in a particular installation. Radiated or conducted electromagnetic signals can cause:
   1) As to devices:
   ● Deviation of the values of pulse duration, amplitudes, and repetition frequencies, may impair the unit’s essential performance. The device has passed EMC highest interference level test, and the parameters do not deviate the essential performance requirement.
   ● The device displays abnormally.
   2) As to patients:
   ● The sensitivity of stimulation may be weaker or stronger, but it does not produce safety issues.
   ● It cannot achieve expected effect.
   If this equipment is found to cause or respond to interfer ence, attempt to correct the problem by one or more of the following measures:
   ● If feeling too weak or too strong stimulation, adjust the strength level to an acceptable level.
   ● If the device display is abnormal, power off and restart the device and check whether it shows properly.
   ● Re-orient or re-locate the affected device.
   ● Increase the separation between the unit and the affected device.
   ● Power the equipment from a source other than that of the affected device.
   ● Consult the service representative for further suggestions.

10. Intended use
    ● The Hearing Aids are used for hearing compensation of patients with mild to moderate air conduction hearing loss.

11. Contraindication
    ● The device is unsuitable and should not be used in the following situations:
    (1) Patients with chronic suppurative otitis media, congenital ear atresia to banned use.
    (2) This hearing aids only be used for compensating the patients with hearing impairment, do not have hearing therapeutic value.

GET TO KNOW YOUR DEVICE

1.1 Hearing aids

1. Microphone 1 – sound enters your hearing aids through the microphone
2. Multi-function button 1 – hearing programs switching and volume increase
3. Multi-function button 2 – hearing aid ON/OFF and volume decrease
4. Microphone 2 – sound enters your hearing aids through the microphone
5. Thin tubing – connects the eartip to hearing aid
6. Stabilizer bar – helps prevent the eartip from moving out of the ear canal
7. Eartip – eartips are soft silicon domes ,and hold the hearing aid comfortably and securely in the ear canal
8. Charging contacts – for hearing aids charging

1.1.1 Left & Right hearing aid markings
There is a red or blue marking on the thin tubing, which helps to distinguish between left and right hearing aid.

• Blue marking is for left hearing aid.
• Red marking is for right hearing aid.

1.2 Charging case

1. Upper Cover
2. Charging slot for left hearing aid – charges and stores hearing aid(L)
3. Charging slot for right hearing aid – charges and stores hearing aid(R)
4. Indicator light for left hearing aid – displays the charging status of hearing aid(L)
5. Indicator light for charging case – displays the charging status of charging case
6. Indicator light for right hearing aid – displays the charging status of hearing aid(R)
7. Charging port – connects the charging case to USB cable

ACCESSORIES

canal
USB Cable × 1| used to charge the charging case
Cleaning Tool × 1| used to clean hearing aids and charging case
Manual × 1| used for users to read and understand how to use hearing aids and other objects.

INSTRUCTION FOR INSERTION DEPTH

For adults,the average length of the ear canal has been estimated to be 23-28mm and the maximum insertion size of the hearing aid is 11.5mm.
So the distance from the eartip to the tympanic membrane after wearing the hearing aid is at least 11.5mm, which is greater than the lower limit of 10mm specified by OTC.
Therefore, the device is safe and complies with OTC regulations.

USING THE HEARING AIDS

4.1 Fitting eartips
Please follow the following steps to apply eartips.The eartips may remain in the ear canal with incorrect replacement when taking the hearing aids off the ear,which will cause hearing damage.
Step 1: Choose a suitable size of eartip

Step 2: Push the eartips rim membrane outward.

Step 3: Hold on the end of the thin tubing and push firmly to ensure that the eartips are fastened securely.

Notes: Please pull the eartips gently to check if it is installed firmly and ensure the eartips won’t fall off easily.
4.2 ON/OFF
4.2.1 TURN ON
Turn on your hearing aids by pressing the multi-function button 2 for about three(3) seconds.You will hear prompt tone according to the hearing program(refer to “Programs switching” )

4.2.2 TURN OFF
Turn off your hearing aids by pressing the multi-function button 2 for about three(3) seconds. You will hear notification sound “Beep Beep Beep”.
4.3 Wear/Remove hearing aids
Keep the hearing aids off before wearing or removing.
4.3.1Wearing hearing aids
Step 1: Choose a suitable size of eartip and mount it in your hearing aids.

Step 2: Place the hearing aids over the top of your ear.

Step 3: Hold the thin tubing where it attaches to the eartips and push the eartips into your ear canal gently.

Step 4: Place the stabilizer bar in your ear so it rests at the bottom of your auricle.

4.3.2 Removing hearing aids
Step 1: Turn off the hearing aids.
Step 2: Pull the stabilizer bar away from the bottom of your auricle.

Step 3: Pull the thin tubing and eartips away from your ear canal gently.
Step 4: Take the hearing aids away from your ear.

Notice:

• Hearing aids will whistle when inserted incorrectly. Reinserting them into your ear canal correctly.
• If whistling remains after reinsertion, replace the eartips with another size and try it again.
• If the hearing aids doesn’t work properly, please check the “7.1 Troubleshooting”. If none of the solutions works, contact our service team.

4.4 Volume control

• The hearing aids have eleven(11) volume levels.
• You will hear the prompt tone “Beep” when you adjust the volume.
• You could increase the volume by pressing the multi-function button 1.
• You could decrease the volume by pressing the multi-function button 2.
• You will hear the prompt tone “Beep-Beep-Beep” at maximum or minimum volume.

4.5 Programs switching

• There are four(4) preset programs in the hearing aids.
• You could switch the hearing programs by pressing the multi-function button 1 for about three(3) seconds.
• Different programs have different beeps as below
  Hearing program| Prompt tone
  ---|---
  1| Standard| Beep
  2| Restaurant| Beep Beep
  3| Outdoor| Beep Beep Beep
  4| Music| Beep Beep Beep Beep
• The hearing aids are designed with the memory function: The last program can be remembered when the hearing aids turned off.

USING THE CHARGER

5.1 Charging the hearing aids
Step 1: Turn off your hearing aids before charging.

Step 2: Place your hearing aids back into the correct slot of the charging case.
Step 3: The hearing aids will start charging automatically.

• Orange indicator lights indicate that the hearing aids are charging.
• Green indicator lights indicate that the hearing aids are fully charged.The indicator lights will go out in about two(2) hours.
• Low battery warning:You will hear notification sound when the remaining battery capacity is almost used out.

5.2 Charging the charging case
Step 1: Connect the B port of the USB cable to the charging port of the charging case.
Step 2: Connect the A port of the USB cable to the power supply.

• Orange indicator light indicates that the charging case is charging.
• Green indicator light indicates that the charging case is fully charged.
• The charging case will charge the hearing aids whatever the upper cover is open or closed.The charging process will stop automatically when the case and hearing aids are fully charged.
• Check the “7.1 Troubleshooting” when failure occurs to your devices.

HOW TO CARE FOR YOUR DEVICES

Please follow the advice below for the best user experience and to prolong the life of your devices.

• Do not drop your hearing aids or knock them against hard surfaces.
• Do not use sharp tools to dislodge ear wax. Sticking household items into your devices can seriously damage them.
• Keep your devices away from high-temperature and/or high-humidity atmosphere.
• Keep your devices clean and dry by using cleaning cloth, to avoid potential damage from humidity or perspiration.
• Do not swim, shower or sauna while wearing the hearing aids.
• You devices should never be rinsed or submerged in water as water drops may block sound or damage the electrical components of the hearing aids.
• Do not attempt to dry the hearing aids or charging case in an oven, microwave or other heating equipment. This will cause them to melt and may cause burns to your skin.
• Do not clean your devices with water, solvent or cleaning fluids.
• Always remove your hearing aids when using hair care products. The hearing aids can become clogged and cease to function properly.
• Store your devices in a clean and dry location.
• Do not use the electronic dryer to store the rechargeable hearing aids.
• Inspect the hearing aids,eartips,and charging case regularly. Remove earwax and debris from your devices by using enclosed cleaning tools.
• Clean the charging contacts of the rechargeable hearing aids with cleaning cloth regularly to ensure the normal charging.
• Eartips should be replaced every 3-6 months or when they become stiff, brittle, or discolored.

FURTHER INFORMATION

7.1 Troubleshooting
7.1.1 Hearing aids fault self-checking table

Wear the hearing aids in your ears correctly
Is the volume very loud?| Reduce the volume.
Are the eartips broken or clogged?| Replace the eartips
Are you holding an object close to the hearing aids?| Move your hand away to create more space between the hearing aids and the objects.
Is your ear full of wax?| Visit your physician.
Issue| Potential cause| Potential solution
---|---|---
No sound| Pressing time is too short to turn on hearing aids.| Turn on your hearing aids in the right way.
Remaining battery capacity is used out.| Charge the hearing aids.
Microphone is clogged.| Clean debris or earwax from microphone.
Voice is weak or fuzzy| Low battery| Charge the hearing aids.
Volume is too low.| Increase the volume level.
Microphone is clogged.| Clean debris or earwax from microphone.

7.1.2 Charging case fault self-checking table

charging case to USB cable correctly.
Battery over-discharging.| Charge the charging case for a period of time.
Charging case can not charge the hearing aids.| Hearing aids are not inserted into the correct slot of charging case.| Insert hearing aids into the correct slot of charging case to charge.
Charging contacts are dirty| Clean the charging contacts of hearing aids and charging case.

7.2 Technical specifications
Test Standard：ANSI 3.22-2014
Test Equipment：FONIX 8000
Test Coupler：HA-2
The standard test ambient conditions shall be:
Temperature: 23 ℃±5 ℃（ 73°±9°F ）
Relative humidity: 0% to 80%
Atmospheric pressure: 760(+37.5,-150)mm of Hg or 101.3(+5,-20)kPa
Operation environment: Temperature: -10 ℃~40°C,
Relative humidity: 30%-75%%RH,
Atmospheric pressure range: 86~106kPa
Storage & transportation environment:
Temperature: -10 ℃~+55 ℃,
Relative humidity: 10%-90%,
Atmospheric pressure range: 70-106kPa

1). OTC Hearing aids technical specifications

Test Items| Program 1| Program 2| Program 3| Program 4
Max. Output(OSPL90)| 116dB| 114dB| 115dB| 114dB
The full-on gain value (HFA FOG@50)| 30dB| 29dB| 32dB| 28dB
The total harmonic distortion value (THD)| 0.5%| 0.6%| 0.3%| 0.4%
The self-generated noise value (EIN)| 22dB| 24dB| 13dB| 25dB
The Latency value| 14ms| 14ms| 14ms| 14ms
Frequency response bandwidth| F1=200Hz F2=5600Hz| F1=210Hz F2=5700Hz| F1=200Hz F2=5600Hz| F1=200Hz F2=5700Hz
Frequency response smoothness| 8dB| 5dB| 6dB| 7dB
2). Battery life & Discharge time of the charging case

Test Items| Value
Battery life of hearing aids| 10h
A pair hearing aids charging time with fully charging case| 3 times

• The data are derived from the measured value of the product at the laboratory, not guaranteed values.

7.3 Regulatory and legal information
Important information regarding Electro Magnetic Compatibility (EMC)
With the increased number of electronic devices such as PC and mobile (cellular) telephones, radio transceivers, mobile radio transmitters, radio- controlled toys, and so on, Medical devices in use may be susceptible to electromagnetic interference from other device. Electromagnetic interference may result in incorrect operation of the medical devices and create a potentially unsafe situation. Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe product situations, the EN60601-1-2 standard has been implemented.
This standard defines the levels of immunity to electromagnetic interference as well as maximum levels of electromagnetic emissions for medical devices.
This unit has been thoroughly tested and inspected to assure proper performance and operation! This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, the following tables recommend minimum separation distances between portable and mobile RF communications equipment and the RJADAT-1 unit.

1. Guidance and manufacture’ s declaration-electro-magnetic emission-for all EQUIPMENT and SYSTEMS.
   Guidance and manufacturer’s declaration-electromagnetic emission

   Hearing aids are intended for use in the electromagnetic environment specified below. The customer of the user of hearing aids should assure that it is used in such an environment.
   Emission test| Classified/Test Level| Compliance| Electromagnetic environment – guidance
   Power line conducted emission test| CISPR 11,Class B, Group 1| N/A| Hearing aids use RF energy only for its internal – function. There- fore, its RF emissions are very low and are not likely to cause any interference in nearby elec- tronic equipment.
   Radiated emission test| CISPR 11, Class B , Group 1| Pass| The hearing-aids are suitable for use in all establishments, other domestic establishments and those directly connect- ed to the public low-voltage power supply network that supplies buildings used for domestic purposes.
   ---|---|---|---
   Harmonic crurent emission test| IEC 61000-3-2, Class A| N/A
   Voltage fluctuations & flicker emissions| IEC 61000-3-3| N/A

2. Guidance and manufacture’ s declaration-electro-magnetic immunity-for all EQUIPMENT and SYSTEMS****
   Guidance and manufacturer’s declaration-electromagnetic immunity for all equipment and systems.

   Hearing aids are intended for use in the electromagnetic environment specified below. The customer or the user of hearing aids should assure that it is used in such an environment.
   Immunity test| IEC 60601 test level| Compliance level
   Electrostatic discharge (ESD) IEC 61000-4-2| Contact discharge:
   ±2 kV, ±4 kV,
   ±6 kV, ± 8 kV
   Air discharge:
   ±2 kV, ±4 kV,
   ±8 kV, ±15 kV| Contact discharge:
   ±2 kV, ±4 kV,
   ±6 kV, ± 8 kV
   Air discharge:
   ±2 kV, ±4 kV,
   ±8 kV, ±15 kV
   Radiated RF electromagnetic fields immunity test| 10V/m,80MHz -2.7GHz
   80% AM at 1KHz RF Band(IEC 60601-1-2:2014+
   A1:2020 section 8.10 table 9)| 10V/m,80MHz-2.7GHz
   80% AM at 1KHz RF Band(IEC 60601-1-2:2014+
   A1:2020 section 8.10 table 9)
   ---|---|---
   Electrical fast transient and burst test
   IEC 61000-4-4| AC port:±2 kV
   Patient coupling port: ±1 kV 100kHz repetition frequency| N/A
   Surge   test IEC 61000-4-5| Line to line: ±500V, ±1kV
   Line to ground: ±500V,±1kV,±2 kV| N/A
   Power frequency (50Hz/60Hz)
   magnetic field IEC61000-4-8| 30 A/m, 50Hz and 60Hz| 30 A/m, 50Hz and 60Hz
   Voltage dips, and interruption IEC 61000-4-11| 0% UT;
   0.5 cycles At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°| N/A
   ---|---|---
   0% UT; 1cycle and 70% UT;
   25 cycles Single phase: at 0°
   0% UT；250 cycles
   Proximity magnetic fields immunity test| IEC 60601-1-2: 2014+A1:2020 section 8.11 table 11| IEC 60601-1-2: 2014+A1:2020 section 8.11 table 11
   NOTE
   UT is the a.c. mains voltage prior to application of the test level.

3. Guidance and manufacture’ s declaration-electro-magnetic immunity-for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING****
   Guidance and manufacturer’s declaration-electromagnetic immunity for equipment and system that are not life- supporting

   The hearing aids are intended for use in the electromag- netic environment specified below. The customer or the user of hearing aids should assure that it is used in such an environment.
   Immunity test| Conducted RF IEC 61000-4-6| Radiated RF IEC 61000-4-3
   IEC 60601 test level| 10 Vrms 150 kHz to 80 MHz| 10V/m 80 MHz to 2.5 GHz
   Compliance level| 10 Vrms| 10V/m 80 MHz to 2.5 GHz
   Electrom-agnetic environment —guidance| Portable and mobile RF communications equipment should be used no closer to any part of hearing aid treatment device including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
   Recommended separation distance

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recom-mended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b
Interference may occur in the vicinity of equipment marked with the following symbol:
---|---

NOTE 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electro- magnetic propagation is affected by absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which hearing aids are used exceeds the applicable RF compliance level above, hearing aids should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating hearing aids.
b. Over the frequency range 150kHz to 80MHz, fields tren-gths should be less than 3V/m.

4. Recommended separation distances between porta-ble and mobile RF communications equipment and hearing aid
   Hearing aids are intended for use in an electromagnetic envi- ronment in which radiated RF disturbances are controlled. The customer or the user of hearing aids can help prevent electro- magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and hearing aids as recommended below, accord- ing to the maximum output power of the communications equip- ment.

   Rated maximum output power of transmitter (W)| Separation distance according to frequency of transmitter (m)
   | 150 KHz to 80 MHz| 80 MHz to 800 MHz| 800 MHz to 2.5 GHz
   0.01| 0.12| 0.12| 0.23
   0.1| 0.38| 0.38| 0.73
   1| 1.2| 1.2| 2.3
   10| 3.8| 3.8| 7.3
   100| 12| 12| 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1:
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2:
These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

7.4 Normalized symbols

| Follow operating instructions
---|---
| B type applied part
| Disposal in accordance with Directive 2012/19/EU (WEEE)
| Date of manufacture| | Manufacturer information
| Serial number| | USE BY
| Warning/ Danger: Improper use might cause serious injuries.
| Medical Device
| Permissible storage and transport temperature and humidity
| Permissible operating temperature and humidity
| Keep Dry| ****| Comply with Directive 2011/65/EU
| Paper Packaging Recycling

Notes: This hearing aid is produced under the strict quality system of Huizhou JINGHAO Medical Technology Co.,Ltd.

• The device fulfills the provisions of the EC directive 93/42/EEC (Medical Device Directive) and the Harmonize Standard as IEC 60601-1, IEC60601-2-66,IEC60118-7,IEC 60118-13,EN ISO 10993-1/-5/-10 ENISO 14971.

7.5 Maintenance, cleaning, storage, and disposal
Maintenance

1. We do not authorize any institution or individual to maintain and/or repair the product.If you suspect that the products may be in question,please contact us immediately.
2. The user must not attempt any repairs to the device or any of its accessories.Please contact us for any repair needs.
3. Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty. Warning : No modification of this equipment is permitted.

Cleaning

1. Cleaning the ear tips
   Remove any earwax buildup using the clean stick.
   Wipe clean with a tissue or soft cloth.

2. Cleaning hearing aids
   Use a soft cloth or tissue to wipe any moisture, perspiration, or debris from the surface of the hearing aids.
   Note: Do not use alcohol or other cleaning solvents to clean the hearing aids as this could damage the protective covering.

Storage

1. Always store your rechargeable devices in the Charging Case when not in use.
2. Do not store or expose the devices and/or case to extreme hot/cold temperatures,moist/humid environments, or shock/vibration.
3. The hearing aids should be fully charged before using for the first time.Do not store the hearing aids for extended periods of time without recharging them (max. six months).

Disposal
Please dispose of the device in accordance with the directive 2012/19/EU – WEEE(Waste Electrical and Electronic Equipment). If you have any questions, please refer to your local authority responsible for waste disposal.
7.6 Warranty
This limited warranty covers defects in material and workmanship for a period of one (1) year from the date of purchase, which includes the hearing devices, charger case, and cord within the warranty period.
Any damage caused by improper handling and care, expo-sure to elements or chemicals, or unauthorized service will not be covered by the warranty. All other damage claims excluded. A warranty claim must be submitted with the purchase receipt.
To return the item, you may also call: 0086-752-2299187 or write to hearingservice@hotmail.com or 23D floor, World Trade Center Building, No.1 Henan’an Road,Huicheng District, Huizhou, Guangdong Province, China Zip Code: 516007 to ensure that both your return and credit refund are processed accurately.

Huizhou Jinghao Medical Technology Co., Ltd.
Address: Floor 6, Huicheng Industry Building, No.9 Huifeng
Dong’er Road, Zhongkai High-tech Zone, Huizhou City, Guangdong Province, China.
Tel: +86-752-2266961
Website: www.jinghao.cc
Email: emily@jhhearingaids.com

CERTIFICATE

Product Name| Hearing Aid
Product Life| 5 years
Model| JH-D26AT
Lot No.| Outside packaging
Inspector|
The product conforms to the national and industrial standards and has passed inspection.

VER: D26AT-20230418-V1

References

• JINGHAO HEARING AIDS

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