Coselgi melodia CMe 15-M, melodia CMe 3-M, melodia CMe 10-M, melodia CMe 5-M User Instructions

USER INSTRUCTIONS
CMe15-M
CMe10-M CMe5-M • CMe3-M MINI Behind-the-ear
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YOUR MELODIA™ HEARING AID
(To be filled out by the hearing care professional)
Date: ______________________________________
Battery size: _________________________________
 CMe15  CMe10  CMe5  CMe3
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CONTENTS
THE HEARING AID ..........................4
Right/left identification ....................... 7
Acoustic indicators .......................... 7
The battery ...............................8
Inserting the battery ....................... 8
Removing the battery ..................... 10
Battery drawer without a nail grip ............ 11
Low battery indication..................... 12
Turning the hearing aid on and off ............. 13
Positioning the hearing aid................... 14
Removing the hearing aid ...................15
Volume adjustment ........................16
Listening programs ........................ 17
Switching between the listening programs ...... 18
Using a telephone ......................... 19
CLEANING...............................20
The hearing aid........................... 21
The microphone openings..................21
ACCESSORIES ............................22
IN CASE OF MALFUNCTION ................. 23
CARING FOR YOUR HEARING AID ............. 25
WARNINGS .............................. 26
ADVICE .................................30
REGULATORY INFORMATION................. 31
SYMBOLS................................ 35
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THE HEARING AID
The illustration below shows the hearing aid without an ear-set. The choice of ear-set solution depends on your specific needs. Please refer to the separate ear-set user manual.
1. Microphone openings
2. On/off function
3. Nail grip
4. LED/RL ID
If you need help to identify the serial number (usually six or sev­en digits) on the product, please contact your hearing care pro­fessional.
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NOTE In addition to these user instructions, a separate user manual is provided describing the various ear-set solutions available for your hearing aid: “Ear-sets for Coselgi™ BTE hearing aids”
WARNING
This booklet and the manual “Ear-sets for Coselgi™ BTE hear­ing aids” contain important information and instructions. Read these booklets carefully before you start using the hearing aid.
NOTE Your hearing aid, ear-set and accessories may not look ex­actly as illustrated in this booklet. We also reserve the right to make any changes considered necessary.
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Intended use
The Melodia hearing aids are intended as air conduc­tion amplification devices to be used in everyday listen­ing environments.
Indications for use
The devices are indicated for individuals with a range of hearing loss severity from minimal (10 dB HL) to mod­erately severe (85 dB HL) and all hearing loss config­urations.
They are to be programmed by licensed hearing care professionals (audiologists, hearing aid specialists, oto­laryngologists) who are trained in hearing (re)habilita­tion.
Description of device
Your hearing aid is used with an ear-set which consists of a tube and an ear-tip, dome or earmould. The hear­ing aid uses a proprietary wireless technology to ena­ble communication between the left and the right hear­ing aids, as well as between the hearing aids and its accessories.
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Right/left identification
The arrow shows the position of the identification mark (red mark = right and blue mark = left).
Acoustic indicators
The hearing aid may be set to produce tones to indicate the use of certain functions.
Function Default
setting
Alternative setting
Adjusting volume via remote control* Tone Off Changing program via remote control Tones Off Starting up the hearing aid Tone Off Warning about low battery 4 tones Off
* Remote control not available for CMe3
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The battery
We recommend zinc-air batteries. Use a size 10 bat­tery for the hearing aid.
To obtain replacement batteries, please consult your hearing care professional. It is important to take note of the expiry date and the recommendations on the bat­tery pack regarding disposal of used batteries.
Inserting the battery
Before inserting a new battery into the hear­ing aid, remember to remove the adhesive tab. Once the tab has been removed, the battery will start functioning after a few sec­onds.
CAUTION
Do not use batteries if there is a sticky residue from the tab or other unwanted substance, as this can cause the hearing aid to malfunction.
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Use the nail grip to gently swing the battery drawer open. Do not press the drawer beyond the open po­sition.
Place the battery in the drawer as illustrated, so that the plus (+) sign on the battery is facing towards you when you hold the hearing aid as shown. You can use the battery magnet provided to steer the battery into place.
If the battery drawer does not close easily, the battery is incorrectly inserted.
When changing battery, it is a good idea to hold the hearing aid over a table.
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Removing the battery
1. Open the battery drawer as previously described.
Place the hearing aid on the provided cloth on a clean, plane surface and turn it as illustrated.
2. Supporting the drawer with your finger, use the bat-
tery magnet provided to push the battery out of the battery drawer from the minus side.
1. 2.
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Battery drawer without a nail grip
The hearing aid may be provided with a battery drawer without a nail grip, which means that you need a tool to open the battery drawer. This type of drawer can be a good choice if the hearing aid is worn by a child. A special tool for opening the drawer will be included with this drawer.
The battery drawer is opened as il­lustrated.
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Low battery indication
An acoustic indicator will sound when the battery is nearly exhausted, unless this function has been dis­abled (see page 7). We recommend that you always have a spare battery with you.
WARNING
Never leave an exhausted battery in the hearing aid. Exhaust­ed batteries may leak, damaging the hearing aid.
WARNING
Your hearing aid may stop functioning, for instance if the battery is exhausted. You should be aware of this possibility, in particular when you are in traffic or are otherwise dependent on warning signals.
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Turning the hearing aid on and off
The battery drawer of the hearing aid also functions as the on/off switch.
Close the battery drawer to turn on the hearing aid. An acoustic indicator will indicate that the hearing aid has been switched on unless this function has been disabled.
Open the battery drawer to turn off the hearing aid.
Please remember to turn off the hear­ing aid when it is not in use. Remove the battery if the hearing aid will not be used for several days.
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Positioning the hearing aid
Insert the earpiece in the ear canal while holding the lower part of the tube. It may help to pull the outer ear backwards and upwards with the opposite hand.
Place the hearing aid behind the ear, so that the hear­ing aid and tube rest comfortably on the ear, close to your head.
The illustrations show an open dome. For further infor­mation on ear-tip/dome/earmould types, anchors and procedures, see the separate ear-set user manual pro­vided.
If the ear-set does not fit or sit properly, causing discom­fort, irritation, redness or the like, contact your hearing care professional.
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Removing the hearing aid
Remove the hearing aid from its position behind the ear.
Carefully pull the earpiece out of the ear canal, while holding the lower part of the tube. If the earpiece is provided with an extraction cord, take hold of this and carefully pull the earpiece out of the ear canal.
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Volume adjustment
The hearing aid volume is adjusted automatically in accordance with your sound environment.
If you have a remote control*, you can also adjust the volume manually or mute your hearing aid. Any ad­justment of the volume setting will be cancelled when your hearing aid is turned off, or when you change program.
In the default setting, any volume adjustment via the remote control will affect both hearing aids.
If you have a remote control, please also refer to the user instructions for this.
WARNING If the volume in the hearing aid is generally too loud or too weak, or the reproduced sounds are distorted, or if you would like any further information, consult your hearing care professional.
* Not available for CMe3
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To mute the hearing aid with a remote control:
Keep pressing the volume down key on the remote con­trol until the long beep-tone has sounded. Pressing one of the volume keys briefly will bring back the sound. The number of programs available depends on your specific hearing aid.
Listening programs
By default, your hearing aid has one listening program. However, if you have a remote control*, a number of additional programs can be made available; how many depends on your specific hearing aid.
Please also refer to the user instructions for your re­mote control.
 Main Standard
 Music For listening to music
 TV For listening to the TV
 Relax Attenuates background noise
 Rearview Focus on sounds from behind
 Phone For listening to the telephone
If your needs change over time, the combination of lis­tening programs can be altered.
* Not available for CMe3
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Switching between the listening programs
Each time you change program via a remote control, an acoustic indicator will sound unless this function has been disabled.
Program 1: One short beep Program 2: Two short beeps Program 3: Three short beeps Program 4: One long and one short beep Program 5: One long and two short beeps
In the default setting, both your hearing aids will be af­fected when you change programs.
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Using a telephone
When using a telephone, we rec­ommend that you hold the tel­ephone against your head at an angle above your ear, rath­er than directly against the ear. If the sound is not optimal, try moving the telephone earpiece to a slightly different position.
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CLEANING
The following cleaning accessories are available for the hearing aid and ear-set *. For cleaning the ear-set, see the user manual “Ear-sets for Coselgi™ BTE hear­ing aids”.
1. Cloth
2. Wax removing tool
3. Cleaning thread
Contact your hearing care professional if you need ad­ditional supplies of cleaning accessories.
* Selection depends on ear-set type
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The hearing aid
Clean the hearing aid with the soft cloth after use.
If the microphone openings are still blocked, contact your hearing care professional.
WARNING
Never use water or cleaning solutions to clean the hearing aid,
as this may cause it to malfunction.
The microphone openings
Clean the microphone openings by passing the wax removing tool straight through the openings.
If you feel resistance, withdraw the tool and try again. Use only the wax removing tool provided.
When the hearing aid is not in use, the battery drawer should be left open, to ventilate the hearing aid and allow it to dry.
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ACCESSORIES
A number of assistive listening devices may be avail­able for your hearing aid.
RC remote control*
TV-Control*
For help in determining whether you could benefit from a remote control or other accessories, please consult your hearing care professional.
* Not available for CMe3
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IN CASE OF MALFUNCTION
The following pages contain some quick advice on what to do if your hearing aid stops working or performs un­satisfactorily. If the problems persist, contact your hear­ing care professional for assistance.
See the “Ear-sets for Coselgi™ BTE hearing aids” user manual for information specific to your ear-set.
Problem Possible cause Solution
The hearing aid is com­pletely silent
The hearing aid is not turned on
Make sure the battery drawer is closed
The battery does not work
Insert a new battery in the battery drawer
The hearing aid volume is not powerful enough
Your ear is blocked by earwax
Contact your ENT doctor/physician
Your hearing may have changed
Contact your hearing care professional
The hearing aid whistles continuously
Your ear is blocked by earwax
Contact your ENT doctor/physician
Your two hear­ing aids are not working in synchrony
The connection be­tween the hearing aids is lost
Turn the hearing aids off and on again
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Problem Possible cause Solution
The hearing aids do not respond with a correspond­ing change in volume or program to the RC
a. The RC is used
beyond the trans­mission range
b. Strong electro-
magnetic interfer­ence in the vicinity
c. The RC battery is
dead or does not work
d. The RC and the
hearing aids are not matched
a. Move the RC closer
to the hearing aids
b. Move away from
known source of EM interference
c. Change the RC bat-
tery
d. Make sure RC is
matched with hear­ing aids (see User in­structions for RC)
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CARING FOR YOUR HEARING AID
The hearing aid is a valuable object and should be treated with care. Here are some things you can do to prolong the life of your hearing aid:
CAUTION
• Turn off your hearing aid when it is not in use. Remove the bat­tery if the hearing aid will not be used for several days.
• When the hearing aid is not in use, keep it in its case in a dry location out of reach of children and pets.
• Do not expose the hearing aid to extreme temperatures or high humidity. Make sure to dry the hearing aid thoroughly af­ter heavy perspiration such as that which may occur during in­tense physical activity, e.g. playing sports.
• Avoid dropping your hearing aid – perform cleaning and bat­tery changes while holding the hearing aid above a soft sur­face.
• Do not wear your hearing aid while in the shower or swim­ming, or when using a hair dryer, perfume, hair and body sprays or gels such as suntanning lotions or creams.
• In environments with high humidity, a drying kit may be used daily to reduce the amount of moisture inside the hearing aid. See the instructions enclosed with the drying kit.
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WARNINGS
WARNING Hearing aids and batteries can be dangerous if swal lowed or used improperly. Swallowing or improper use can result in severe injury or even fatalities. In case of ingestion, con­tact a physician immediately.
• Keep hearing aids and their parts, accessories and batter-
ies out of reach of children and anyone else who might swal­low such items or otherwise cause injury to themselves. Do not change batteries in front of them and do not let them see where you keep your battery supply. Discard used batteries carefully.
• Batteries are very small and can easily be mistaken for pills or
the like. Never put a battery or hearing aid in your mouth for any reason as you may risk swallowing it.
• Clean and inspect your hearing aid after use to check that it is
intact. If the hearing aid or the ear-set breaks while in the ear canal, contact your hearing care professional immediately. Do not try to remove the parts yourself.
• Risk of explosion if battery is replaced by an incorrect type or
recharged. Dispose of used batteries according to the instruc­tions.
• Never allow others to wear your hearing aid, as this could
cause permanent damage to their hear ing.
• When selecting a listening program, please remember that
there are situations in which it is particularly important to be able to hear the surrounding sounds (e.g. traffic, warning sig­nals).
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WARNING
• The hearing aid is made of modern non-allergenic materials. Nonetheless, in rare cases skin irritation may occur. If you no­tice skin irritation in or around your ear or ear canal, contact your hearing care professional.
• Be aware that the use of any type of hearing aid may involve a slightly increased risk of infection in the ear canal. An infec­tion can arise as a result of inadequate ventilation of the ear. We therefore recommend that you remove the hearing aid and ear-set from your ear at night to allow the ear canal to be ven­tilated. Make sure that you clean and inspect your hearing aid and ear-set as required. If an infection occurs, you should seek medical attention and contact your hearing care profession­al for advice on how to disinfect the various hearing aid parts. Do not under any circumstances use alcohol, chlorine or sim­ilar substances.
• Do not use the hearing aids in mines or other areas with ex­plosive gases.
Do not wear your hearing aid during radiation, X-rays, MRIs, CT or other medical treatments and scans. The emissions from these procedures as well as from other types of radiation, such as that in a microwave oven, can damage your hearing aid and the hearing aid can become very hot. Radiation from, for example, room surveillance equipment, burglar alarms and mobile phones is weaker and will not damage the hear­ing aid, but may create audible interference.
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WARNING
Interference with active Implants
• In order to show caution, we advise to follow the guidelines recommended by manufacturers of defibrillators and pace­makers regarding use of mobile phones:
• If you wear an active implantable device keep the Wireless Hearing Aids and Hearing Aid Accessories such as wireless remote controls or communicators at least 15 cm away from the implant.
• If you experience any interference, do not use the hearing aids and contact the manufacturer of the implant. Please note that interference can also be caused by power lines, electrostatic discharge, airport metal detectors etc.
• If you have an active brain implant, please contact the manu­facturer of the implant for risk evaluation.
If you have an implantable device, we advise to keep mag­nets* at least 15 cm away from the implant. (*= can be spec­ified as Autophone magnet, hearing instrument case, magnet in a tool, etc.)
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CAUTION
• Your hearing aid has been tested for interference according
to international standards. Nevertheless, it is possible that un­foreseen interference may occur in the hearing aid due to elec­tromagnetic radiation from other products such as alarm sys­tems, room surveillance equipment and mobile phones.
• Although your hearing aid has been designed to comply with
the most stringent international electromagnetic compatibility standards, the possibility cannot be excluded that it may cause interference with other equipment, such as medical devices.
• Never try to open or repair the hearing aid yourself (Only to be
performed by authorised personnel).
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ADVICE
NOTE
• The hearing aid will not restore normal hearing and will not prevent or improve a hearing loss resulting from organic con­ditions. However, the hearing aid can help you to make the best possible use of your remaining hearing ability. You should also bear in mind that it can take time to get used to a new hearing aid and new sounds.
• In most cases, using the hearing aid infrequently will not per­mit you to gain full benefit from it.
• The use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading.
• The use of hearing aids increases the risk of accumulation of earwax. Contact your physician/ENT doctor if you suspect that a plug of earwax has accumulated in your ear. Earwax may not only reduce your own hearing but also the effect of the hear­ing aid considerably. It is a good idea to ask your physician to clean your ears a couple of times a year.
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REGULATORY INFORMATION
FCC ID: TTY-C4M IC: 5676B-C4M
Federal Communications Commission Statement
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, and (2) this device must accept any interference received, including in­terference that may cause undesired operation.
NOTE: 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.
NOTE: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
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Changes or modifications to the equipment not expressly ap­proved by Coselgi could void the user’s authority to operate the equipment.
Industry Canada Statement / Déclaration d’industrie Canada
Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada.
To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropi­cally radiated power (e.i.r.p.) is not more than that necessary for successful communication.
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions:
(1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause undesired operation of the device.
Conformément à la réglementation d’Industrie Canada, le présent émetteur radio peut fonctionner avec une antenne d’un type et d’un gain maximal (ou inférieur) approuvé pour l’émetteur par In­dustrie Canada.
Dans le but de réduire les risques de brouillage radioélectrique à l’intention des autres utilisateurs, il faut choisir le type d’antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas l’intensité nécessaire à l’établissement d’une communication satisfaisante.
Le présent appareil est conforme aux CNR d’Industrie Canada ap­plicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes :
(1) l’appareil ne doit pas produire de brouillage, et
(2) l’utilisateur de l’appareil doit accepter tout brouillage radioé­lectrique subi, même si le brouillage est susceptible d’en compro­mettre le fonctionnement.
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Directive 1999/5/EC
Hereby, Coselgi A/S declares that this CMe-M is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.
A copy of the Declaration of Conformity according to 1999/5/EC can be found at:
http://www.coselgi.com/products/doc
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Electrical and electronic equipment (EEE) contains materials, components and sub­stances that can be hazardous and present a risk to human health and the environment when waste electrical and electronic equip­ment (WEEE) is not handled correctly.
Do not dispose of hearing aids, hearing aid accessories and batteries with ordinary household waste.
Hearing aids, batteries and hearing aid accessories should be disposed of at sites intended for waste elec­trical and electronic equipment, or given to your hear­ing care professional for safe disposal. Proper dispos­al helps to protect human health and the environment.
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SYMBOLS
SYMBOLS
Symbols commonly used by Coselgi A/S in medical device labelling (labels/IFU/etc.)
Symbol Title/Description
Manufacturer
The product is produced by the manufacturer whose name and address are stated next to the symbol. If ap­propriate, the date of manufacture may also be stated.
Date of manufacture
The date when the product was manufactured.
Use-by date
The date after which the product is not to be used.
Batch code
The product’s batch code (lot or batch identification).
Catalogue number
The product’s catalogue (item) number.
Serial number
The product’s serial number.*
Keep away from sunlight
The product must be protected from light sources and/or The product must be kept away from heat
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Symbol Title/Description
Keep dry
The product must be protected from moisture and/or The product must be kept away from rain
Lower limit of temperature
The lowest temperature to which the product can be safely exposed.
Upper limit of temperature
The highest temperature to which the product can be safely exposed.
Temperature limits
The highest and lowest temperatures to which the prod­uct can be safely exposed.
Consult instructions for use
The user instructions contain important cautionary infor­mation (warnings/precautions) and must be read before using the product.
Caution/Warning
Text marked with a caution/warning symbol must be read before using the product.
WEEE mark “Not for general waste”
When the product is to be discarded, it must be sent to a designated collection point for recycling and recovery.
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Symbol Title/Description
CE mark
The product is in conformity with the requirements set out in European CE marking directives.
Alert
The product is identified by R&TTE Directive 1999/5/EC as an equipment Class 2 product with some restrictions on use in some CE member states.
C-Tick mark
The product complies with EMC and radio spectrum regulatory requirements for products supplied to the Australian or New Zealand market.
Interference
Electromagnetic interference may occur in the vicinity of the product.
*The six- or seven-digit number on the product is the serial num­ber. Serial numbers may not always be preceded by
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COSELGI A/S Nymoellevej 6, DK-3540 Lynge, Denmark
www.coselgi.com
É[5qr0w3|l;;a;h]
COSELGI and MELODIA are trademarks of Coselgi A/S
Manual no.:
9 514 0239 001 #03 Issue: 2014-08
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