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SomnoDent® Flex

SomnoDent® ClaSSiC

SomnoDent® eDent

Instructions for use and care

SomnoDent®Sleep Apnea Device

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Contents

Treatment with SomnoDent® Contents 2

How the SomnoDent oral sleep device works 3

Instructions for daily use 3

Using the bite tab 3

Cleaning 4

Recommendations and instructions for cleaning 4

Warnings for cleaning 4

Repair of damaged devices 4

Warranty 5

Warnings / Contraindications 5

Possible side effects 5

Storage and transport of your device 5

Regular inspection 5

Re-adjustment of the device after dental restoration 5

Titration instructions 6

Titration protocol 7

SomnoDent® container and accessories 8

For further information visit www.somnomed.de

Dear SomnoDent® user

As you may already know and as has been demonstrated by many scientific studies, you may expect your new oral sleep device to of-fer healthy, restful sleep.

Please read the instructions on the correct use and care of your SomnoDent® oral sleep device carefully. The instructions for care and storage of your SomnoDent® oral sleep device are applicable for the following types:

• SomnoDent®Flex• SomnoDent®Classic• SomnoDent®Edent

Do not hesitate to contact your dentist if you have any further ques-tions.

YourSomnoMed®Team

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NormalDuring normal sleep the muscles that control the tongue and soft pal-ate hold the airway open

SnoringThese muscles relax during sleep. The tissues of the upper airway vi-brate as air passes over them, creat-ing a snoring noise. SleepapneaIf the muscles are too weak to hold the tongue and pharyngeal muscle in position, the airway may become obstructed and dangerous respira-tory arrests may occur.

TreatmentwithSomnoDent®

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RemovalAlways remove the lower plate first. Using your thumbs on both sides under the edge of the plate, gently pull the lower plate in an upwards motion and remove it. Gently pull the upper plate down with both index fingers and thumbs to remove it.

UsingthebitetabWhen you remove the plates in the morning your bite may temporarily feel slightly different. The bite tab will help you relax your muscles. Place it between your upper and lower front teeth and move your lower jaw back until the feeling of tension dissipates.

The SomnoDent® oral sleep device treats obstructive sleep apnea and snoring by advancing the lower jaw, which keeps the airways open.

The device is made to measure for you and consists of a upper and lower plate with a patented “fin guide”.

HowtheSomnoDent®oralsleepdeviceworks

Note:As with many new products you may experience sensitivity to taste and odor when you use the device for the first time. This will disap-pear quickly if you store your device in lukewarm water during the day for no more than three days. Clean the device thoroughly after removing it from the water bath. After that, the SomnoDent® oral sleep device must be stored dry in the storage container during the day (see also page 5).

Tip:uselipbalmforthefirstfewnights. Important:Alwayscleanyourdeviceaftereachuse!

Dailyuseofyourdevice

1.InsertingtheupperplatePlace the upper plate in your mouth. Press upwards on the plate with both thumbs to ensure that it fits securely and comfortably.

2.InsertingthelowerplatePlace the lower plate in your mouth. Press down on both sides of the plate using your index fingers to ensure that it fits securely.

3.PushthefinsgentlyintotheguideOnce the upper and lower plates are securely in position, bring your lower jaw slightly forwards to allow the ‘fins‘ to engage the guide in the upper jaw. Slowly close your mouth until your lips lightly touch each other..

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Cleaningthedevice

We recommend the following for cleaning your Somno-Dent® oral sleep applicance:

• Inthemorningafterremovingthedevicerinseit under running water and clean it thoroughly with a toothbrush everyday.

• Cleanthetitrationunitsontheleftandright thoroughly with the included cleaning brush.

• AftercleaningtheSomnoDent®roalsleepdevice dry it and store in the container.

• Keepthedeviceandcontainerawayfrom direct sunlight.

• UsethecleaningagentsrecommendedbySomnoMed®.

Warningsforcleaning

Cleaning tablets containing active oxygen for dentures may perma-nentlydamage the plastic of your SomnoDent® oral sleep device. This will invalidate the warranty. Toothpaste may also damage your oral sleep device .

Neverusehotorboilingwater!Hot or boiling water damages your SomnoDent® oral sleep device and this will invalidate the warranty.

Repairofdamageddevices

Damaged or broken devices must not be used. Continuing use may cause injury. Contact your dentist immediately. The dentist will ar-range for your oral sleep device to be repaired by an expert.

For repairs and warrantyclaims always contact your dentist im-mediately.

Cleaningthetitrationunit

Clean the spaces inside the titration unit carefully and thoroughly with the cleaning brush

Recommendationsandinstructionsforcleaning

ThesoftSMHB-FlexinsideoftheSomnoDent®oralsleepdevicemaybecome discoloured by contact with amalgam fillings, mouthwash solutions, medications (coagulation agents) and hemoglobin. Coffee, tea, red wine, cola beverages and nicotine may also cause discolora-tion. This will not affect the function and longevity of the device.

Important:Alwayscleanyourteeththoroughlybeforeinsertingthedevice.

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Warranty

Your SomnoDent® oral sleep device is custom made from premium grade, biocompatible materials. This will ensure accuracy of fit, com-fort and durability.

It is warranted against manufacturing defects and material faults for two years in EU countries. It is warranted for one year in Norway, Iceland and Switzerland.

In spite of comprehensive studies and reports confirming the success of SomnoDent® oral sleep devices, we cannot guarantee that using aSomnoMed®oralsleepdevicestopssnoringand/oralleviatesob-structive sleep apnea because the conditions of each individual differ.

Thewarrantydoesnotinclude:

• Adjustment of devices after treatment that changes the shape of the teeth (new crowns, bridges).

• Correctionsrequiredasaresultifincorrectbiteimpressions,e.g.too short or too long protrusion, incorrect occlusal plane.

• Repairsrequiredbecauseofincorrecttitrationanduse.

Warnings/Contraindications

Donotwearthedeviceifanyofthefollowingarepresent:• initialandadvancedperiodontitis• looseteeth• ifyouarenot18yearsoldIf you wear dentures, please follow the instructions of your dentist regarding the use of SomnoDent® oral sleep devices.

Possiblesideeffects

Increased salivation when you start using the device is possible. Wearing the device may cause temporary muscle tension (muscle ache). This should slowly diminish after removing the device. If any side effects persist even after using the bit tab, contact your dentist.

Long-term use may cause slight changes in your bite. Therefore, we recommend routine inspections by your dentist.

Storageandtransportofyourdevice

Always store your SomnoDent® oral sleep device in the storage con-tainer after cleaning it thoroughly. The container is also suitable for use during travel and when visiting the dentist.

RegularinspectionofyourSomnoDent®oralsleepdevice

Regularly inspect your oral sleep device for sings of damage, cracks or flaws. If the device is damaged, immediately take it to your dentist, who will arrange for it to repaired by a SomnoDent® laboratory.

Take the device to your regular dental checkups.

Re-adjustmentofthedeviceafterdentalrestoration

After a new dental restoration, i.e. crowns, bridges or fillings, the device has to be relined or clinically adjusted.

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SomnoDent®Titrationinstructions

The SomnoDent® sleep apnea device was adjusted by The Som-noDent® sleep apnea device was adjusted by your dentist to meet your requirements perfectly. However, occasional feelings of tension may occur at the beginning of treatment. These can usually be alleviated by slight titration (fine adjustment) of the advancing mechanism.

KeyhousingforfineadjustmentThe key housings to the left and right of the maxillary splint can be fine-adjusted if required.

ThequarterturnEach turn – from stop wto stop – corresponds to a quarterturn(90º).This means, the supplied titration key is inserted once and turned in the direction of the arrow until the stop. Then the titration key needs to be inserted again for the nextquarterturn.

A quarter turn of the key housing – in direction of the arrow – equals anadvanceof0.1mm.

Right:the titration key is inserted into the loweropening of the screw thread and turned upwards (in direction of the arrow) until it reaches the stop.

Left:the titration key is inserted

into the upper opening of the screw thread and turned downwards

(in direction of the arrow) until it reaches the stop.

Important:You must always turn

bothscrews with the same number of quarterturns in the direction

of the arrow.

A titrationkey are included ex-factory.

Each complete quarter turn (in direction of the arrow) equals an advanceof0.1mm.

10quarterturns=1mmadvance.

– 1 mm A + 5 mm

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In ex-factorypositionA a forward advance of 5 mm (50 quarter turns) and 1mmbackwards(10quarterturns)are possible.

Date Number of turns Number of turns to the left to the right

TitrationprotocolDentist / Practice stamp:

Serial number of the sleep apnea device:

Initial setting % of maximum

possible protrusion of mm

Howfarcanthescrewsbetitrated(fine-adjusted)?

In ex-factory condition (corresponds to bite registration), the Som-noDent®sleepapneadevicecanbetitratedbackwardsby1mm(10quarter turns) and forwards by 5 mm (50 quarter turns).

SomnoMed®recommendthatthescrewsareonlyturnedtoamaxi-mum of 5 mm (50 quarter turns) forward advance (from ex-factory condition).

If the screws are unscrewed completely by accident (50 quarter turns), the key will continue to turn but without any advance movement.

This is a safety feature to prevent small components from entering the oral cavity.

Whathappens if you cannot remember how far youhaveturned?

If you are unsure as to how many turns you have performed, care-fully turn both screws back (against the direction of the arrow) until the gap on the housing is closed and you can feel slight resistance. Please donotcontinueturning as this may damage the screw and/or the housing.

Youcanreturntotheoriginalposition(ex-factorysetting)with10quarter turns in the direction of the arrow on both sides of the sleep apnea device.

Important:Makeanoteofthenumberofturnsforeachside

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SomnoDent® storage, cleaning and travel container andSomnoDent®accessories

The SomnoDent® oral sleep device is delivered safely and protected in the SomnoDent® container. Always keep your oral sleep device in this practical container after cleaning it thoroughly.The SomnoDent® accessory set with cleaning brush, bite tab and titration key is in the bottom of the container.

SomnoDent®accessories(fastened in the bottom of the container)

Cleaningbrush

Bitetab

Titrationkey

SomnoDent®storage,cleaningandtravelcontainer

10901-EN-UKSomnoDentFlexUserGuide©

bySomnoMed01/2015

SomnoDent®Sleep Apnea Device

SomnoMedAGEuropeBaarerstrasse125CH-6300 Zug, SwitzerlandTel: +41(0)415014640Fax +41(0)415014642info@somnomed.comwww.somnomed.eu

EU, Switzerland, United States, Canada,Australia,SouthKorea,Japan,HongKong

SomnoMedAGisISOcertified.SomnoMedproductsareregistered:

SomnoMedproductsarepatented and EU-compliant.

JJThompson(OrthodonticAppliances)Ltd.95HillStreet-Sheffield,S24SPTel: +44(0)1142759585Fax: +44(0)1142758385email: info@jjthompson.co.ukwww.somnomed.eu