ExSilent Qleaf Pro User Manual [de]

User manual Gebruikershandleiding Gebrauchsanweisung Mode d’emploi Manual de usuario
English Qleaf Pro user manual 3
Nederlands Qleaf Pro gebruikershandleiding 35
Deutsch Qleaf Pro Gebrauchsanweisung 63
Français Mode d’emploi du Qleaf Pro 91
Español Qleaf Pro manual de usuario 119
Qleaf Pro user manual
English 3
Qleaf Pro
Congratulations on your purchase of the Qleaf Pro. With the purchase of a Qleaf Pro, you are guaranteed a product composed of high-quality components. By the application of several important innovations in the eld of hearing aids, the Qleaf Pro ensures stylish, pleasant hearing adapted for modern day use.
Table of contents
What is Qleaf Pro? 6
Warnings 22
Qleaf Pro’s anatomy 8
Qleaf Pro - module (A) 9 Soft tip (B) 10 Battery (C) 10
The daily use of Qleaf Pro 11
Place the battery 11 Eject the battery 11 Insert Qleaf Pro in the soft tip 12 Remove Qleaf Pro from the soft tip 14 Place Qleaf Pro in the ear 15 Remove Qleaf Pro from the ear 17 Fitting procedure and conguration 17 Switch between programs 17
Maintenance and use 20
Cleaning 20 Storage 21
Information about reparation services 28
Disclaimer 31
The data of your Qleaf Pro 32
Warranty 33
Manufacturer 147
English 5
What is Qleaf Pro?
The Qleaf Pro is a modular (same for each ear) CIC* device with a standard tting, for which a soft tip is used.
For the power supply, a battery of type 10 (yel­low sticker) is required. The device is provided with an advanced microprocessor, which ensures the processing and amplication of the sound, adapted to your particular hearing loss.
The Qleaf Pro uses a soft tip with large, medium and small sizes. The size of the soft tip depends on the size of your ear canal. Choosing the cor­rect size is extremely important. If the soft tip is too large, the device might become less com­fortable to wear. If the soft tip is too small, the device might exhibit spontaneous whistling. During tting, your dispenser will try to nd the size of soft tip that suits you best.
One of the most common repair reasons is damag­ing or clogging of the speaker due to ear wax. The Qleaf Pro has a built-in system that prevents the intrusion of ear wax into the device. As a result, this hearing aid module can not easily be damaged or clogged by ear wax. In case the soft tip will be clogged, it can easily be cleaned or replaced.
The Qleaf Pro is provided with a microproces­sor including the following characteristics:
• An adaptive ‘antifeedback’ system – this pre­vents spontaneous ‘whistling’ of the device. It is possible that the device ‘whistles’ when you insert it in your ear. This is normal. As soon as you have tted it deep in your ear canal, the whistling will stop and the antifeedback system will protect you.
• An adaptive ‘noise reduction’ system – this improves the hearing comfort in noisy envi­ronments.
* Completely In the Canal
• Four dierent memories – this means that you may use up to four dierent settings while programming the Qleaf Pro. You may request your dispenser to program to your special needs (such as a special setting for listening to music or a setting where the Qleaf Pro serves as a damper). When the Qleaf Pro has been set up with more than one program (memory), the memories can be selected by AirTAP functionality. For a description about this functionality, please refer to the chapter ‘Switch between programs’ (page 17).
• Data logging; a feature that stores daily usage and can be analyzed during examinations.
As a result of the combination of size, shape, innovative construction and material, the Qleaf Pro oers a range of important advantages:
• Almost invisible.
• Minimal distortion of your own voice (occlusion).
• High sound gain by positioning of the speaker close to the ear drum.
• Natural sound, because the ear functions like it is supposed to. This is possible because the microphone is right in your ear, so you hear with natural ‘directivity’
• Minimum wind noise, because the micro­phone is positioned deep into the ear
• Protects against damage caused by ear wax.
• Suitable for cell phone use. Please note that if the softtip touches the cell phone in an uncomfortable way when you hold the phone to your ear, you should shorten the softtip to match your ear size (see page 10).
• Suitable for sporting activities.
• Easy to use and maintain.
• Contemporary design.
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Qleaf Pro’s anatomy
A Qleaf Pro - module (casing)
1 Battery compartment 2 Colored side indicator 3 Microphone opening 4 Opening for battery ejection 5 Speaker opening
B Soft tip
6 Sound opening 7 Domes 8 Pull cord
C Battery (type 10)
9 Plus pole (+) 10 Minus pole (–) 11 Battery ejection tool
A
1
3
2
4
5
6
B
8
7
10
C
9
11
Qleaf Pro module (A)
Casing (A)
The casing has been made of durable plastic. For the maintenance of the casing, please refer to the chapter ‘Maintenance and use’ (page 20).
Battery compartment (1)
This compartment comprises of the battery – a type 10 cell battery - that provides the power supply for Qleaf Pro. The device is switched o upon the removal of the battery. The battery compartment is used for two purposes: in normal situations it serves to hold the battery but it can also be used by the audiologist to program the device with a special programming tool.
Colored side indicator (2)
By using two di erent colors, the left and right ear module can be identi ed.
• Red: right ear
• Blue: left ear
Microphone opening (3)
Here the microphone is located that picks up the sound, which is processed and ampli ed by the Qleaf Pro.
Opening for battery ejection (4)
The added battery ejection tool is used through this opening. See chapter ‘Eject the battery’ (page 11).
Speaker opening (5)
The processed and ampli ed sound emits through this opening and is directed via the soft tip towards the ear drum.
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Qleaf Pro’s anatomy
Soft tip (B)
The soft tip of the Qleaf Pro is made of a biocompatible plastic and designed as a disposable, thus enabling it to be replaced regularly. For its maintenance and cleaning, please refer to the chapter ‘Maintenance and use’ (page 16). The illustration can be di erent from your choice of size for soft tip.
Sound opening (6)
The processed and ampli ed sound emits through this opening and is directed towards the ear drum.
Domes (7)
The domes ensure a seal, which prevents the sound of the speaker to interfere with that of the microphone. Additionally, the domes provide a good ‘seal’ inside the ear.
10 English
Pull cord (8)
To take the Qleaf Pro out of the ear, the pull cord is used. After insertion of the Qleaf Pro the pull cord will be situated behind the tragus (see page 16), which makes it nearly invisible. To improve invisibility even more, you may choose to clip the pull cord of the softtip and shorten it using regular scissors. This will also improve phone comfort. Please make sure that you do not clip the softtip too short (keep at a minimum two ribs) so that you can still remove the device comfortably from your ear.
Battery (C)
Qleaf Pro uses type 10 cell batteries, in the package indicated with a yellow sticker. The device is switched o upon the removal of the battery.
The daily use of Qleaf Pro
Before you start any of the actions mentioned in chapters ‘The daily use of Qleaf Pro’ and ‘Maintenance and use’, make sure you are using a clean and horizontal working surface.
Place the battery
While using a new battery:  rst remove the sticker from the + pole. Hold the module (colored side indicator facing to the right) and insert the battery as indicated.
Eject the battery
Hold the module and eject the battery with the added tool.
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The daily use of Qleaf Pro
Insert Qleaf Pro in the soft tip
• Insert the module into the soft tip with the CE mark  rst and visible.
12 English
Make sure your hands are clean while inserting the Qleaf Pro. Make-up, crème, body oil, gel, hairspray and likewise products can dirty up the module and can, for example, contribute to the clogging of the microphone opening.
• Next, simultaneously push the Qleaf Pro device with the thumb in the soft tip and pull the pull cord.
• Please make sure that the module is inserted all the way into the soft tip.
English 13
The daily use of Qleaf Pro
Remove Qleaf Pro from the soft tip
• Pull the pull cord to the front* of the Qleaf Pro and ‘peel’ the soft tip from the module as far as possible. Tip: You can choose to leave the soft tip partially on the device and only remove it as far that you can remove the battery with the battery ejection tool. This is quicker.
• Place the Qleaf Pro device (the part without soft tip around it) between your  ngers and pull it out of the soft tip.
14 English
* The front of the Qleaf Pro is the part that goes in the ear  rst.
tragus
Place Qleaf Pro in the ear
• Put the end of the soft tip with the dome(s) loosely in the ear. The pull cord is situated behind the tragus, directing towards the nose.
Inserting a new soft tip can be a bit bothersome because the surface of a new soft tip is somewhat rigid and as a result of the fact that some ears are quite ‘dry’. Using some lubricant gel or crème can help in these cases (a tiny amount is su cient).
N.b.: Note that the lubricant does not clog the sound opening!
tragus
English 15
The daily use of Qleaf Pro
• Insert the device into the ear by pressing on the  at side of the device. Now gently push the device deeper into the ear. If the mouth is opened wide, insertion will be easier.
Ideally, the  at side of the module (where the microphone is situated) will be  ush to the entry of the ear canal after insertion. In this way, the device is practically invisible and the sound optimal. There are cases where the ear canal is too small: In that case, it is possible for the device to protrude a few millimetres.
If the pull cord protrudes after the insertion of the device, after which it becomes visible, it can be easily custom-cut by the dispenser.
16 English
Remove Qleaf Pro from the ear
Hold the pull cord rmly and pull it – always slowly - out of the ear.
Fitting procedure and conguration
The tting procedure and conguration of the hearing aid is both an important and individual process. For this reason, consult your dispenser for any complaints about the tting or conguration. Your dispenser is the authorized person to carry out any necessary modications.
Switch between programs
When the Qleaf Pro has been congured with more than one program (memory), programs can be selected by AirTAP functionality. To change between the programs, the hearing aid wearer pats the ear gently with the hand. The pats generate an air pressure change that is detected by the hearing instrument to change the program.
The Qleaf Pro is by default tuned with a single tap function. This mode requires the user to tap the ear once to activate the switch. The dispenser can adjust this to a two-tap function in consultation with the user. This additional mode requires the user to tap the ear twice to switch to the next program. This last mode
English 17
The daily use of Qleaf Pro
will prevent the programs from switching unexpectedly, by - for example - a slamming door.
Should the user not want to use the di erent programs, the AirTAP function can also be turned o . After the insertion of the battery, the device is set by default to program one. Gently tapping on the ear will produce two beeps, indicating that program two has been switched on.
After another gentle tap, three beeps will be audible indicating that program three has been activated. A maximum of four programs can be set up. While program four is active, after a gentle tap one beep becomes audible and the device sets back to program one.
18 English
Please note that while tapping the hand touches the softtip in an uncomfortable way, you could shorten the softtip to match your ear size (see page 10).
English 19
Maintenance and use
Although the Qleaf Pro module can be used for both right and left ears, the settings are usually dierent for the right and left ear. This means that once the module has been tted, you should not use it in the other ear. Provided that you use the same size soft tip in both ears, it doesn’t matter if you switch soft tips.
The building up of ear wax diers from one person to another. Therefore it cannot be avoided completely that the sound outlet of the soft tip will be clogged with ear wax. Although the sound volume may reduce because of clogging, this should normally not damage your device. In case you observe that the sound outlet of the soft tip has been clogged, you may clean the soft tip (see paragraph ‘Cleaning’) or replace it.
Check the module(s) and the soft tip(s) daily
20 English
for clogs and damages. This guarantees you an optimal performance and a long operational life. If you notice that the soft tip is damaged, it is important that you do no longer use it. Replace it immediately! To keep the performance of your device optimal and minimize the chance of infection, we advise you to replace the soft tip with a new one at least once a month. Soft tips are available at your dispenser.
Cleaning
Module:
• Clean daily with a soft and dry tissue.
• In case of severe dirt, wipe with special (moist) cleaning tissues for hearing aids.
Soft tip:
• Clean daily with a soft and dry tissue.
• In case of severe dirt, you may clean it either with special (moist) cleaning tissues, with soluble cleaning tablets for hearing aid products or you may alternatively have it cleaned with an ultrasound cleaner.
• Clogged soft tips can be rinsed o under streaming tepid water. In case of severe or persistent dirt, if a change in the properties or damage of the material occurs, the soft tip should always be replaced.
N.b.: Never use aggressive cleaning products, abrasives or solvents! This can cause irrevocable damage to the soft tip or the module.
Storage
At night:
We recommend that you remove the soft tip from the module during the night: Remove the
battery from the device and store it in a secure place outside its box. In this way, you increase the operational life of the battery and also allow for the evaporation of moisture possibly present in the device.
Short-term storage:
You may use the carrying box, when you want to remove the device from the ear temporarily.
Long-term storage:
When you do not use your hearing aid over a longer period of time, clean the module and soft tip before storing them inside the carrying box. Always remove the battery from the device in this situation.
English 21
Warnings
The soft tip is an essential part of the Qleaf Pro. Without the soft tip, the
Qleaf Pro will not be able to function properly and this could cause irreversible dirtying of the module. For this reason, never use the module without the soft tip.
Once the device has been tted, you should not wear it in the other ear. This generally leads to a deterioration of hearing performance and could sometimes even result in hearing loss.
Never use damaged or dirtied soft tips. This can negatively aect the hearing performance or result in an uncomfortable t, which in turn could lead to infections of the ear.
Replace the soft tip of your device regularly, even if it is not visibly damaged or dirtied, see chapter ‘Maintenance and use’ (page 20).
22 English
When using Qleaf Pro for the rst time, begin with a continuous wearing period of 4 hours and subsequently increase wearing time with one hour a day. If you suer from pain, continuous irritation or itching, do not use the devices before you receive specialist advice. If your complaints persist, consult a physician. Have your ears and your hearing checked regularly, both during the beginning period and afterwards.
If for some reason it is not possible to remove Qleaf Pro from your ear, consult your dispenser or a physician.
Do not use the Qleaf Pro in the following cases:
• A medical history of the ear.
• Exostoses (bulging bone growth) in the ear canal.
• Heavy ear wax secretion.
The device should not be:
• dropped.
• exposed to moisture or water.
• immersed in water.
• used while swimming, taking shower, bathing or in the sauna.
• cleaned wet.
• exposed to extreme high temperatures, such as when using a hair dryer.
• worn in mines or other environments where explosion risk is high.
• exposed to X-ray radiation or strong magnetic elds, such as during medical investigation.
• worn in the places where hairspray (hairdresser) or solvents (such as dye) are used.
Care should be taken in using make-up, crème, body oil, gel, hairspray and similar products, while you are wearing or inserting the Qleaf Pro. They can dirty up your device and, for example, contribute to the clogging of the microphone opening.
Keep the Qleaf Pro away from small children and pets. In case of swallowing one of the components, there is a choking hazard to small children.
Empty batteries and old hearing aids should be collected and disposed as chemical waste.
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Warnings
Warning to hearing aid dispensers
A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions: (i) Visible congenital or traumatic deformity of the ear. (ii) History of active drainage from the ear within the previous 90 days. (iii) History of sudden or rapidly progressive hearing loss within the previous 90 days. (iv) Acute or chronic dizziness.
24 English
(v) Unilateral hearing loss of sudden or recent onset within the previous 90 days. (vi) Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz. (vii) Visible evidence of signicant cerumen accumulation or a foreign body in the ear canal. (viii) Pain or discomfort in the ear.
Special care should be exercised in selecting and tting a hearing aid whose maximum sound pressure level exceeds 132 decibels because there may be risk of impairing the remaining hearing of the hearing aid user. (This provision is required only for those hearing aids with a maximum sound pressure capability greater than 132 decibels (dB).)
Important notice for prospective hearing aid users
Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treatable conditions that may aect hearing are identied and treated before the hearing aid is purchased.
Following the medical evaluation, the physician will give you a written statement that states that your hearing loss has been medically evaluated and that you may be considered a candidate for a hearing aid. The physician will refer you to an audiologist or a hearing aid dispenser, as appropriate, for a hearing aid evaluation.
The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable the audiologist or dispenser to select and t a hearing aid to your individual needs.
If you have reservations about your ability to adapt to amplication, you should inquire about the availability of a trial-rental or purchase-option program. Many hearing aid
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Warnings
dispensers now oer programs that permit you to wear a hearing aid for a period of time for a nominal fee after which you may decide if you want to purchase the hearing aid.
Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician. Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged.
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Children with hearing loss
In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child. An audiologist is qualied by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss.
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Information about reparation services
The Qleaf Pro has been developed by ExSilent BV, Overschiestraat 63, Amsterdam. For your complaints or reparation requests, you should contact the provider from whom you purchased your device. Complaints and reparations settlement may vary by provider.
Limited Manufacturer’s Warranty.
This limited guarantee will be applicable in any part of the world. ExSilent BV (”ExSilent”) guarantees that this ExSilent product (”Product”) is free from defects in materials, design and nish at the time of its original purchase subject to the following provisions and conditions:
1. This limited guarantee is given to the end user of the Product (”Client”). It is given without exclusion or restriction of (i) any of the Client’s binding statutory rights or (ii) any of the Client’s rights against the seller/concessionaire of the Product.
28 English
2. The guarantee period is twenty four (24) months from the date on which the rst Client purchased the Product. In the event of a successive purchase or other change of owner/ user, the guarantee period will continue for the remaining part of the twenty four (24)-month period and remain unaected in all other respects.
3. During the guarantee period, ExSilent or its approved service provider will repair or replace the defective Product (fully at the discretion of ExSilent). ExSilent will return the repaired Product or another Product to the Client in good condition. All components or other equipment which are replaced will become the property of ExSilent.
4. A replaced product will be given an extended or renewed guarantee period. In case of a repaired product, the old guarantee will continue to apply.
5. This limited guarantee does not cover
painted covers or other comparable personalized components.
6. This limited guarantee is not applicable
to damage caused by normal wear and use. Neither will this limited guarantee be applicable if: (i) the defect was caused by the fact that the Product was subjected to: use in conict with the owner’s or user directions, rough treatment, exposure to moisture, damp or extreme thermal or environmental conditions or rapid changes in such conditions, corrosion, oxidation, non-permissible alterations or connections, non-permissible openings or repairs, repairs made with non-permissible replacement parts, incorrect use, improper installation, accidents, force majeure, spilling of food or liquids, the inuence of chemical products or other facts over which ExSilent cannot reasonably have
control (including but not limited to defects in consumable components, such as batteries which only have a limited life by nature) unless the defect has been caused directly by defects in materials, design or nish; (ii) ExSilent or its approved service provider received no notication of the defect from the Client within thirty (30) days of the occurrence of the defect within the guarantee period; (iii) the Product was not returned to ExSilent or its approved service provider within thirty (30) days of the occurrence of the defect within the guarantee period; (iv) the serial number was removed, erased, damaged, changed or is illegible; (v) the defect was caused by the fact that the Product was used with or was connected to an additional component which was not manufactured or supplied by ExSilent or used for a purpose other than that for which it was intended; (vi) The defect was caused by the fact
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Information about reparation services
that the battery was subjected to a short-circuit or that the connecting pieces of the battery housing or cells were broken or show evidence of tampering or that the battery was used in another device than that for which it is intended.
7. In order to make a claim under the limited guarantee, the Client must send a legible and unaltered, fully-completed original guarantee card to ExSilent or its authorized service provider within two weeks of purchasing the Product.
8. This limited guarantee is the sole and exclusive remedy available to the Client against ExSilent and the sole and exclusive liability of ExSilent towards the Client for defects in or poor functioning of the Product. This limited guarantee replaces all other guarantees and liabilities, including verbal, written, (non binding) statutory, contractual, unlawful and
30 English
otherwise. ExSilent is not liable for any indirect, secondary or consequential damage, costs or expenses. Neither is ExSilent liable for any direct damage, costs or expenses, if the Client is a legal entity.
9. Any amendment or change to this limited guarantee requires the prior written approval of ExSilent.
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