Aika CH-F306 Body Worn Hearing Aid User Manual

Aika CH-F306 Body Worn Hearing Aid

Product Information

Specifications:

• Product Name: Warrantyard
• Product Model: -17
• FCC Compliance: Part 15 of FCC Rules
• RF Exposure: General RF exposure compliant

Product Usage Instructions

General Usage:
The Warrantyard -17 is a versatile product designed for stamp service. It complies with FCC regulations regarding RF exposure and can be used in portable conditions without restrictions.

Steps to Use:

1. Ensure the product is charged and powered on.
2. Place the device in a suitable location for stamp service.
3. Follow the specific stamping instructions provided with the device.
4. After use, power off the device and store it in a safe place.

FAQ (Frequently Asked Questions)

1. Q: Is the Warrantyard -17 suitable for outdoor use?
   A: Yes, the device can be used in portable exposure conditions without restrictions, making it suitable for outdoor use.

2. Q: How do I report a fault with the product?
   A: If you encounter any issues with the product, please provide details such as purchase date, customer name, address, and a description of the fault. Contact Customer Support for further assistance.

• This instruction manual shall be combined with the technical requirements of the product and the Instruction Manual.
• Before using this product, please read the product instruction manual carefully or purchase and use it under the guidance of medical personnel.
• Please refer to the Instruction manual for taboos and precautions. Please keep it properly after reading for reference at any time.

[Scope of application]
Supplementary hearing for patients with air conduction hearing loss.

[Structure and composition]
Host (including microphone, audio amplifier circuit, receiver, neck silicone tube, Bluetooth module, shell), headset cable and earplug.

[Contraindications, precautions, warnings and hints]

Contraindications

1. Congenital atresia of the external ear or posthumous deformity of the external ear, a large number of foreign bodies in the external auditory canal
2. Deafness is unstable, the degree of hearing loss often fluctuates
3. Complaints of headache, dizziness, earache, tinnitus and other obvious symptoms
4. Cases of deafness in the past 3 months, progressive rapid deafness, obvious unilateral deafness or other acute ear diseases
5. Middle ear effusion and frequent pus discharge;
6. Central deafness; non-organic deafness;
7. Acute otitis externa, tympanitis, chronic suppurative otitis media (in the period of purulent infection);
8. Acute suppurative otitis media is not suitable for wearing air conduction hearing aids;
9. Non air conduction hearing patients and those with mild hearing loss(valuc between 0 30dB);
10. Those who arc allergic to the materials of this product.Precautions:

Precautions

1. Before fitting a Body-Worn hearing aid, it should undergo a professional inspection and hearing test, and use it under the guidance of a doctor or a professional fitter of Body-worn hearing aids.
2. Moisture proof, shock proof and high temperature proof.
3. Do not make the Body wearing hearing aid immersion in any liquid, in the bath should be taken off the body wearing hearing aid, ear canal dry after wearing the body wearing hearing aid.
4. After removing the Body-Worn hearing aid at night, it should be placed in a box with desiccant, protected from light, high temperature, high humidity, and to avoid falling.
5. The outer surface of the Body-Worn hearing aid should be kept clean, and the earwax in the earplug should be cleaned frequently.
6. The function and volume control switch should be used correctly, try to turn on and off lightly, and avoid excessive force and excessive force.
7. Choose the right size ear cap, sealed good ear canal, so as not to wear the body type hearing aid scream.
8. Increase the volume gradually to avoid damaging eardrums when the volume suddenly increases.
9. Do not pull or twist the earphone or the earphone connection to avoid breaking. Hold the earplug handle when removing the earplug.
10. Body Worn hearing aids should be regularly sent to the fitting center for maintenance and inspection to ensure that the body-worn hearing aids arc in good condition.
11. For users who wear Body-Worn hearing aids for the first time, if their ears are blocked or their voice is too loud (you should adjust the tightness of the earplugs and adjust the volume and loudness), they will gradually adapt to it within three months.
12. The rechargeable battery will overheat, catch fire and explode in abnormal use environment (high temperature, high humidity). After using it for a period of time, it is found that the sound becomes smaller, indicating that the power is insufficient, and it should be charged in time.
13. When suspending the use of the Body-Worn hearing aid, please turn off the power to prolong the battery life.
14. When using this product, please keep away from high-voltage equipment and signal transmitting devices, so as to avoid the danger of interference and malfunction.
15. There are sensitive electronic components in the Body-Worn hearing aid product, so please do not use the Body-Worn hearing aid directly in an environment with strong electromagnetic interference (such as near a mobile power supply, microwave oven, etc.}, because it may cause accuracy distortion.
16. Storage environment for Body-Worn hearing aid’s temperature: -20°C~55°C, relative humidity: 93%, atmospheric pressure: 86kPa~ 106kPa, should be placed in a ventilated, non-corrosive gas; Transportation environment: temperature: -20″C~55″C, relative humidity:  93%, atmospheric pressure: 86kPa~l06kPa, it should be protected from direct exposure lo sunlight, rain, snow or mechanical collision; Use environment: temperature: 0″C~40°C, relative humidity:  80%, atmospheric pressure: 86kPa~l06kPa.
17. Do not place the Body Worn hearing aid in a place prone to splashing water, high temperature, humidity, direct sunlight, dust or corrosive gases. Also do not use this product in the above environment.

Safety Alert

1. To avoid accidental swallowing by children, keep the body-worn hearing aid away from children and pets.
2. Do not throw the product into fire to avoid explosion.
3. Body-worn hearing aids can only be used by people with hearing loss, the rest cannot.
4. Special users: when children wear it, it needs to be done with the help of adults. Psychiatric patients using Body-Worn hearing aids should consult a doctor.

[Illustration of product parts]

[Product performance parameters]

Rated power supply current consumption nominal value is 6mA
Operating Voltage| DC 3.7V (lithium battery)
Normal working conditions| Temperature: 0°C~40°CRelative humidity:80% Atmospheric pressure: 86kPa~106kPa
Storage conditions| Temperature: -20°C~SS°C Relative humidity:93%
Atmospheric pressure: 86kPa~106kPa Ventilation, no corrosive gas
Shipping conditions| Temperature: -20°C~SS°CRelative  humidity:93% Atmospheric pressure: 86kPa~106kPa It should be protected from direct exposure to sunlight, rain, snow or mechanical collision
Bluetooth| Bluetooth version: BTS.3 Transmit power: -2d bm~8dbm Frequency offset: -15KHz ~ +15KHz Receiving sensitivity:-80dbm Frequency band: 2402 ~ 2480 MHZ Frequency characteristics: 2.4GHz ISM frequency band and frequency modulation, frequency hopping technology Modulation type: GFSK n/4-DQPSK Warning: Even if other devices meet the emission requirements of the corresponding national standards, the hearing aid may still be interfered by other devices.
Classification by type of protection against electric shock| Internal power supply
Classification according to the degree of protection against electric shock| Has a Type B applied part
Classified according to the degree of protection against ingress| Ordinary equipment {IPX0 not waterproof)
Classification by operating mode| Belonging to continuous operation equipment
Classified according to the degree of safety when used in the case of flammable anesthetic gas mixed with air or flammable anesthetic gas mixed with oxygen or nitrous oxide: equipment that cannot be used in these two situations (non-AP/APG type);
This product has no applied parts with protection against the effects of defibrillation discharges
This product has no signal output part
Permanently Installed Equipment or Non-Permanently Installed Equipment: Non- Permanently Installed Equipment
Electromagnetic compatibility is classified according to GB 4824 and belongs to Group 1, Class B

[Troubleshooting]

*Note: Do not disassemble and repair your Body-Worn hearing aid without authorization to avoid damage

1. Switch off
2. The battery is dead or too low
3. The sound outlet is blocked

|

1. Turn on the switch
2. Please charge in time
3. Clean the sound outlet

**** Small volume|

1. Low battery
2. The sound outlet of the earplugs is blocked
3. Too much earwax
4. Changes in hearing loss

|

1. Please charge in time
2. Clean the earplugs
3. Clean the ear canal or seek medical attention
4. Consult a doctor

**** Howling|

1. Loose earplugs
2. Earcapistoosmall

|

1. Take off the earplugs and wear them again
2. Replace the ear cap of appropriate size

**** Power consumption|

1. Hearing aid are not turned off when not in use
2. Hearing aid damp

|

1. Turn off the hearing aid when not in use
2. Use desiccant or consult a doctor pregnancy

[Installation and use instructions]

One. Unpacking
Open the single-package color box containing the body-worn hearing aid, take out the plastic box from the single-package color box containing the body-worn hearing aid, and then open the plastic box and take out the body-worn hearing aid.

Two.The preventive inspection

1. Check whether the battery power is low;
2. Check whether the volume is adjusted in the appropriate range;
3. Check whether the sound hole of the earplug is blocked by earwax.

Three. Wear and use

1. Select the ear cap that fits the patient’s size, and then
   Put the earcapinto the earplugs;

2. Power on: Turn the power switch to “on”, the blue light is on and the voice prompt is on;

3. Adjust the volume adjustment button of body wearing hearing aid to the minimum position, and then Insert the ear cap of the body wearing hearing aid into the ear and move it up and down to confirm the wearing Wear correctly, and then adjust the volume button to the clearest sound can be;

4. Power off: Switch the power switch to the “Off” position when the power is on, and the light is off.

Four. Operation and Mode Switching
Volume adjustment

• Hearing aid mode: press the “+/-” key to increase/decrease the volume of hearing aid. The blue light flashes quickly. After each button operation, there will be a prompt sound of “beep”.When the volume reaches the maximum, it indicates that the volume has reached the maximum; when the volume reaches the minimum, it indicates that the volume has reached the minimum.
• Bluetooth mode: press “+/-” button to increase/decrease bluetooth volume, and the green light blinks slowly. After each button operation, there will be a prompt sound of “beep”.

Play/Pause
In bluetooth mode, short press” >11″ key to play and pause the audio.

Next/previous song adjustment
In the bluetooth music play/pause state, long press the” 1″ button for 2 seconds to realize the function of the next song; In the bluetooth music play/pause state, press and hold the”-” button for 2 seconds to realize the function of the previous song.

Mode switch

• Modes include: bluetooth mode (without medical-related information), hearing aid mode

In bluetooth mode, short press the “M” button to switch to hearing aid mode, and respond to incoming call status, call status, call stop and reject operations; after connection, the headset will always be connected to bluetooth, and you need to disconnect bluetooth on the mobile phone. In hearing aid mode, short press the “M” button to switch to bluetooth mode, and respond to play music, pause music, call status, call status, stop call and reject operations; In hearing aid mode, long press the “M” button to switch four simulation scene modes in a cycle, and there  will be a prompt sound for each mode when switching.

• Mode 1: General mode
• Mode 2: indoor mode
• Mode 3: Outdoor mode
• Mode 4: Movie-watching mode

Low power reminder and charging instruction

Low electricity remind
Low voltage alarm, working indicator light blue flashing once every 5 seconds, alarm interval 60s, voice prompt “low power, please charge”.

Charging indicator
The charging indicator is off when no charging device is connected. After the charging device is connected, the charging  indicator is steady orange during the charging process. When the device is fully charged, the charging indicator is off.

Bluetooth operation
Bluetooth connection

1. Turn on the bluetooth of the mobile phone;
2. After the body wearing hearing aid is turned on, press the “M” key to switch to bluetooth mode, enter the pairing mode, and wait for bluetooth connection. The bluetooth name of the device is “CH-F306”. During the waiting process, the blue light flashes quickly.
3. Select the device whose bluetooth name is “CH-F306” on the mobile phone, and start connecting to bluetooth;
4. After the connection is successful, the working indicator light of the body wearing hearing aid flashes green slowly.

Bluetooth disconnect

1. The bluetooth is turned off on lhe mobile phone, lhe headsel enlers Lhe pairing state, and the blue indicator flashes quickly.
2. Beyond the connection range, the headset enters the pairing state, and the blue indicator blinks quickly.
3. After the headset is switched to the hearing aid mode, the headset will always be connected to Bluetooth. You need to disconnect the Bluetooth at the mobile end, and the blue indicator will flash quickly.

Tips: If no connection is made within 5 minutes in bluetooth mode, enter standby mode and press any key to wake up.

Answering, rejecting and hanging up calls

• Answering an incoming call: When an incoming call is in, short press” >11 “button to answer the call;
• Reject a call: When a call comes in, long press the “>11″key for 2s to reject the call;
• Hang up the call: during the call, short press “>11” button to hang up the call.

Five. the use of accessories
Use of ear cap
Choose the right ear cap: users with large ear canals choose large ear cap, users with small ear canals choose small ear cap, the machine is equipped with three different sizes of ear cap (make sure the ear cap fit tightly with the ear canal, otherwise it will cause acoustic feedback and cause whistling). The ear cap are reusable, and the ear cap should be frequently cleaned of earwax from the ear cap and disinfected with medical alcohol.

The use of batteries
When the hearing aid is not in use, please charge it regularly to avoid battery damage. The recommended charging interval for hearing aids is 30 days.

[Product care and maintenance method]

Product maintenance

1. Power off the Body-Worn hearing aid when it is not in use;
2. The Body-Worn hearing aid should be stored in a dry place, and the Body-Worn hearing aid should be removed when bathing to avoid immersion in water.
3. Try not to let sweat flow into the Body-Worn hearing aid when using it in summer;
4. Handle with care to avoid falling, pressing and collision.
5. Avoid placing it with strong magnetic fields, otherwise it will affect the sensitivity of the Body-Worn hearing aid.
6. The Body-Worn hearing aid should be stored in a place that is not easy for children to find, so as not to be used by children to play.

Recommended cleaning and disinfection procedures
Use a medical alcohol cleaning spray on a dry cloth to clean the Body-Worn hearing aid housing. Please clean the earbuds regularly to ensure proper use of the Body-Worn hearing aid.
Use a brush to clean the dust and dirt on the Body-Worn hearing aid, and disinfect it with medical alcohol.

Store

1. Please keep the Body-Worn hearing aid in the box when not in use. If you do not use the unit for a long time, you should turn off the power in time to avoid battery damage. The recommended charging interval for hearing aids is 30 days.
2. Do not place the Body-Worn hearing aid in places prone to splashing water, high temperature, humidity, direct sunlight, dust or corrosive gases.

[Parts List]

• Before use, please check whether the host and accessories are complete according to the packing list. If you find that the following items are inconsistent with this information, please contact the manufacturer.

[Description of replacement cycle and replacement method of worn products]
The detachable parts of this product mainly include ear cap. Before installing the accessories, please confirm whether the specifications and models of the accessories are consistent with the original regulations. Please be sure to use the parts specified by our company. If necessary, please contact the seller or manufacturer, If other parts or materials are used for the model parts specified by our company, the minimum safety level will be reduced.

[Declaration]
The consumer/dealer may, upon request, provide circuit diagrams, component lists, legends, calibration details, or other qualified technicians to assist the user in repairing parts of the equipment designated by the manufacturer as repairable. material.

[Explanation of graphics, symbols, abbreviations, etc. used in medical

device labels]

The purpose of the warning signs and illustrations shown in the manual is to enable you to use this product safely and correctly, and to prevent injury to you and others.
Warning symbols, legends and meanings are as follows.

[Name and content of toxic and hazardous substances or elements in the product]

diphenyl ethers (PBDE)
printed circuit board assembly| **X| ****0| ****0| ****0| ****0| ****0
plastic| 0| 0| 0| 0| 0| 0
Battery| X| 0| 0| 0| 0| 0
****Remark:
** 0: Indicates that the content of the toxic and hazardous substances in all homogeneous materials of the part is below the limit requirement specified in the SJ/T11363-2006 standard.
X: Indicates that the content of the toxic and ha rmfuI substance in at least one homogeneous materia I of the component exceeds the limit requirements specified in SJ/T11363-2006 standard.

[Electromagnetic Compatibility]
Notice

• The Body-Worn hearing aid CH-F306 complies with the relevant requirements of the YY0505-2012 standard and the GB/T 25102.13-2010 standard electromagnetic compatibility.
• The user should install and use it according to the electromagnetic compatibility information provided in the random document.
• Portable and mobile RF communication equipment may affect the performance of the CH-F306 Body-Worn hearing aid. Avoid strong electromagnetic interference during use, such as close to mobile phones, microwave ovens, etc.;
• Guidelines and manufacturer’s declarations are detailed in the appendix

warning
Body-Worn hearing aids should not be used near or stacked with other equipment, and if they must be used near or stacked, they should be observed to verify that they function properly in the configuration in which they are used. Except for cables sold by the manufacturer of the Body-Worn hearing aid CH-F306 as spare parts for internal components, the use of unspecified accessories and cables may result in an increase in emissions or a decrease in the immunity of the Body Worn hearing aid CH F306. Even if other devices meet the emission requirements of the corresponding national standards, the Body- Worn hearing aid CH-F306 may still be interfered by other devices.

Appendix

Guidelines and Manufacturer’s Statement- Electromagnetic Emissions

The CH-F306 Body-Worn hearing aid is expected to be used in the following electromagnetic environment, and the purchaser or user should ensure that it issued in this electromagnetic environment:
launch test| compliance| Electromagnetic environment-guide
RF emission GB4824| Group 1| CH-F306 Body Worn hearing aid Use RF energy only for its internal function. Therefore, it has low RF emissions and is less likely to cause interference to nearby electronic equipment
RF emission GB4824| Class B| ** CH-F306 Body Worn hearing aid Suitable for use in all installations, including domestic installations and direct connection to domestic residential public low voltage supply networks
Harmonic emission GB 17625.1| Not applicable
Voltage fluctuation/ flicker emission GB17625.2| Not applicable
Guidelines and Manufacturer’s Declaration – Electromagnetic Immunity**

The CH-F306 Body-Worn hearing aid is expected to be used in the following electromagnetic environment, and the purchaser or user should ensure tliat it is used in this electromagnetic environment:
Immunity test| IEC 60601Test Levels| Match level| Electromagnetic environment- guide
Electrostatic discharge GB/T 17626.2| ±6 kV contact discharge
±8 kV air discharge| ±6 kV contact discharge
±8 kV air discharge| Floors should be wood, concrete or tile, and if covered with synthetic materials, the relative humidity should be at least 30%.
Electrical fast transient burst GB/T 17626.4| ±2kVto power line
±lkVon input/ output lines| Not applicable| Not applicable
Surge
GB/T 17626.5| ±1 kV differential mode voltage
±2 kV common mode voltage| Not applicable| Not applicable
Voltage dips, short interruptions, and voltage variations on power input lines GB/T 17626.11| <5 % UT for 0.5 cycles (on UT, >95% dip/40 % UT for 5 eye es (On UT, 60% dip)
70 % UT for 25 cycles (on UT, 30% dip)
<5 % UT for 5s (on UT, >95% dip)| Not applicable| **** Not applicable
Power frequency magnetic field (50/60Hz) GB/T 17626.8| 3A/m| 3A/m| The power frequency magnetic field shall have the characteristics of the power frequency magnetic field level of a typical location in a typical commercial or hospital environment.
Note: UT refers to the AC network voltage before applying the test voltage
Immunity test| IEC 60601 Test Levels| match level| Electromagnetic environment-guide
---|---|---|---
|

3 V (rms) 150kHz~80M Hz

3V/m
80MHz~2.5GHz

| | ** Portable and mobile RF communication equipment should not be placed closer than the recommended separation distance CH-F306 Body Worn hearing aid any part used, including cables.
This distance should be calculated by a formula corresponding to the frequency of the transmitter.
RF conduction| | Recommended isolation distance
GB/T 17626.6| Not applicable| d= 1.2.’P
| | d = l.2v’P      80 MHz~800 MHz d = 2.3.’P       800 MHz~2.5 GHz
radio frequency radiation
GB/T 17626.3| ** 3V/m| where:
P-According to the transmitter manufacturer’s maximum rated output power of the transmitter, in watts (W);
d- Recommended separation distance, in meters (m) b.
The field strength of fixed radio frequency transmitters is determined by surveying the electromagnetic field c, and shouId be lower than fhe compliance level in each frequency ranged.
Interference may occur near equipment marked with the following symbols.
Note 1: At 80MHz and 800MHz, the formula for the higher frequency band is used.
NOTE 2 These guidelines may not be suitable for all situations, and electromagnetic propagation is affected by absorption and reflection from buildings, objects and people.

1. Stationary transmitters, such as base stations for wireless (cellu tar/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasting, and television broadcasting, have field strengths that cannot be predicted theoretically with accuracy. To assess the electromagnetic environment affixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location where the CH-F306 Body-Worn hearing aid is located is higher than the applicable RF compliance level above, the CH-F306 Body-Worn hearing aid should be observed to verify its normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or repositioning the CH-F306 Body-Worn hearing aid.
2. In the entire frequency range of 150KHz ~ 80MHz, the field strength should be less than 3 V/m.

Recommended isolation distance between portable and mobile RF communication equipment and CH-F306 Body-Worn hearing aid

The CH-F306 Body-Worn hearing aid is intended for use in electromagnetic environ ments where radio frequency radiation disturbances are controlled. Depending on the maximum rated output power of the communication equipment, the purchaser or user can prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the CH-F306 Body-Worn hearing aid as recommended below.
**** Transmitter rated maximum output power/W| Isolation distance corresponding to different frequencies of the transmitter/m
150 kHz~ 80 MHz d = 1.2JF’| 80 kHz~ 800 MHz d = 1.2JF’| 800 MHz~ 2.5 GHz d=2.3JF’
0.01| Not applicable| 0.12| 0.23
0.1| Not applicable| 0.38| 0.73
1| Not applicable| 1.2| 2.3
10| Not applicable| 1.8| 7.3
100| Not applicable| 12| 23
For transmitter rated maximum output power not listed in the table above, the recommended isolation distanced, in meters (m), can be determined using the for mula in the corresponding transmitter frequency column, where Pis provided by the transmitter manufacturer Transmitter maximum output power rating in watts (W).
NOTE 1 At 80 MHz and 800 MHz, the formula for the higher frequency range applies.
NOTE 2 These guidelines may not be suitable for all situations, and electromagnetic propagation is affected by aosorption and reflection from buildings, objects and people.
The field strength of the RF test signal when the Body-Worn hearing aid complies with the immunity of the Body-Worn hearing aid specified in GB/T 25102.13

| Neighbor Compatibility
IRIL 55dBunder the following field strength Field strength is 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| I| 3| I| 2| I

[After-sale service]

Thank you for choosing Body-Worn hearing aid. In order to protect your rights and interests, the company provides the following after-sales services:

Warranty Service
If the product is faulty due to the local components, you can choose to return, replace or repair the product within seven days of purchase. In the purchaseThis product within 15 days, you can choose to replace the new machine or repair. Enjoy free maintenance service within 12 months of purchase.

Special reminder

Conditions that are not eligible for the “Three Guarantees policy” :

• The expiry date of the three parcels is beyond;
• Failure or damage caused by failure to use, maintain or store in accordance with the requirements of the Operation Manual;
• Failure or damage not caused by design, technology, manufacturing, quality or other problems of the product;
• Failure or damage caused by force majeure;
• The attached parts are not covered by warranty;

Warrantyζa rd

product name
Product model| | Stamp Service
---|---|---
Purchase date|
Customer
name|
Customer phone|
Customer address|
Fault description|
Repair result|

FCC Warning Statement

Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This equipment has been tested and found to comply 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, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, 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 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.

FCC Radiation Exposure Statement
The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction.
This device complies with Part 15 of the FCC Rules.

Operation is subject to the following two conditions:

1. This device may not cause harmful interference.
2. This device must accept any interference received, including interference that may cause undesired operation.

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