SomnoDent® Instructions for use and care
Contents
1. SomnoDent sleep apnea appliance Instructions for use and care Sleep breathe live better a Somnolled Dental Sleep Medical Contents Treatment with SomnoDent How the SomnoDent oral sleep appliance works Instructions for daily use Using the bite tab Cleaning Recommendations and instructions for cleaning Warnings for cleaning Repair of damaged devices Warranty Warnings Contraindications Possible side effects Storage and transportation of your appliance Regular inspection Re adjustment of the appliance after dental restoration Titration instructions Titration protocol SomnoDent container and accessories For further information visit www somnomed eu OND a ToT THN A A A A WU W W N Dear SomnoDent user As you may already know and as has been demonstrated by many scientific studies you may expect your new oral sleep appliance to offer healthy restful sleep Please read the instructions on the correct use and care of your SomnoDent oral sleep appliance carefully The instructions for care and storage of your Somno Dent oral sleep appliance are applicable for the follow ing types e SomnoDent Flex e SomnoDent Classic e SomnoDent Edent Do not hesitate to contact your dentist if you have any further questions Your SomnoMed Team Treatment with SomnoDent Normal During normal sleep the mus cles that control the tongue and soft palate2. e cleaning agent recommended by SomnoMed Cleaning the titration screw Clean the spaces inside the ti tration screw carefully and thor oughly with the cleaning brush Recommendations and instructions for cleaning The soft SMH B Flex inside of the SomnoDent oral sleep appliance may become discoloured by contact with amal gam fillings mouthwash solutions medications coagula tion agents and hemoglobin Coffee tea red wine cola beverages and nicotine may also cause discoloration This will not affect the function and longevity of the appliance Important Always clean your teeth thoroughly before inserting the appliance Warnings for cleaning Cleaning tablets containing active oxygen for dentures may permanently damage the plastic of your Som noDent oral sleep appliance This will invalidate the warranty Toothpaste may also damage your oral sleep appliance Never use hot or boiling water Hot or boiling water damages your SomnoDent oral sleep appliance and this will invalidate the warranty Repair of damaged devices Damaged or broken devices must not be used Continuing use may cause injury Contact your dentist immediately The dentist will arrange for your oral sleep appliance to be repaired by an expert For repairs and warranty claims always contact your dentist immediately Warranty Your SomnoDent oral sleep appliance is custom made from premium grade biocompatible materials This will ens
3. e may cause slight changes in your bite Therefore we recommend routine inspections by your dentist Storage and transportation of your appliance Always store your SomnoDent oral sleep appliance in the storage container after cleaning it thoroughly The container is also suitable for use during travel and when visiting the dentist Regular inspection of your SomnoDent sleep appliance Regularly inspect your oral sleep appliance for signs of damage cracks or flaws If the appliance is damaged im mediately take it to your dentist who will arrange for it to be repaired by a SomnoDent laboratory Take the appliance to your regular dental checkups Re adjustment of the appliance after dental restoration After a new dental restoration i e crowns bridges or fill ings the appliance has to be checked and adjusted by your dentist Titration instructions The SomnoDent sleep apnea appliance has been ad justed by your dentist to meet However occasional feelings of tension may occur at the beginning of the treatment These can usually be allevi ated by slight titration fine adjustment of the advancing mechanism Key housing for fine adjustment The key housings to the left and right of the maxillary splint can be fine adjusted if required The quarter turn Each turn from stop to stop corresponds to a quar ter turn 90 This means that the supplied titration key is inserted once and turned in t
4. he direction of the arrow until the stop Then the titration key needs to be inserted again for the next quarter turn A quarter turn of the key housing in direction of the ar row equals an advance of 0 1 mm A titration key is included in the delivery range a p 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 both screws with the same number of quarter turns in the direction of the arrow Right The titration key is inserted into the lower opening of the screw thread and turned upwards in direction of the arrow until it reaches the stop Each complete quarter turn in direction of the arrow equals an advance of 0 1 mm 10 quarter turns 1 mm advance How far can the screws be titrated fine adjusted When delivered from the laboratory corresponds to bite registration the SomnoDent sleep apnea device can be titrated backwards by 1 mm 10 quarter turns and for wards by 5 mm 50 quarter turns SomnoMed recommends that the screws are only turned to a maximum of 5 mm 50 quarter turns forward advance from ex factory condition In ex factory position A a forward advance of 5 mm 50 quarter turns and 1 mm backwards 10 quarter turns are possible If by accident the screws are turned by more than 50 quarter turns the key will c
5. hold the airway open Snoring These muscles relax during sleep The tissues of the upper airway vibrate as air passes over them creating a snoring noise Sleep apnea If the muscles are too weak to hold the tongue and phar yngeal muscle in position the airway may become obstructed and dangerous respiratory ar rests may occur How the SomnoDent oral sleep appliance works The SomnoDent oral sleep ap pliance treats obstructive sleep apnea and snoring by advanc ing the lower jaw which keeps the airways open The appliance is made to mea sure for you and consists of a upper and lower splint with a patented fin guide Note As with many new products you may experience sensitivity to taste and odor when you use the appliance for the first time This will disappear quickly if you store your appli ance in lukewarm water during the day for no more than three days Clean the appliance thoroughly after removing it from the water bath After that the SomnoDent oral sleep appliance must be stored dry in the storage container during the day see also page 5 Instructions for daily use 1 Inserting the upper splint Place the upper splint in your mouth Press upwards on the splint with both thumbs to ensure that it fits securely and comfort ably 2 Inserting the lower splint Place the lower splint in your mouth Press down on both sides of the splint using your index fin gers to ensure that it fits
6. ion key SomnoDent storage cleaning SomnoDent accessories and travel container fastened in the bottom of the container SomnoMed AG Europe Schaffhauserstrasse 466 8052 Zurich Switzerland l SomnoMed AG is SomnoMed products are SomnoMed products T 00800 766 66 633 ISO certified registered in are patented and T 41 0 43 443 92 13 p EU Switzerland United States Canada EU compliant F 41 0 43 443 92 15 eE D E SomnolV ed info somnomed eu ae Nos medics C Dental e Sleep Medical www somnomed eu ISO 13485 scenizerkace citation 10901 EN SomnoDent by SomnoMed 04 2013
7. ontinue to turn but without any advance movement This is a safety feature to prevent small components from entering the oral cavity What happens if you cannot remember how far you have turned If you are unsure as to how many turns you have per formed carefully 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 do not continue turning as this may damage the screw and or the housing You can return to the original position ex factory setting with 10 quarter turns in the direction of the arrow on both sides of the sleep apnea device Important Make a note of the number of turns for each side Titration protocol Dentist Practice stamp Serial number of the sleep apnea device Initial setting of maximum possible protrusion of__ _ S mm Date Number of turns Number of turns to the left to the right SomnoDent sleep apnea appliance SomnoDent storage cleaning and travel container and SomnoDent accessories 2i V Cleaning brush The SomnoDent oral sleep appliance is delivered safely e lt i lt 2 Bite tab and protected in the SomnoDent container Always keep your oral sleep appliance in this practical container after cleaning it thoroughly The SomnoDent accessory set with cleaning brush bite tab and titration key is secured in the bottom of the con tainer a Titrat
8. securely 3 Push the fins gently into the guide Once the upper and lower splint 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 Tip Use lip balm for the first few nights Removal Always remove the lower splint first Using your thumbs on both sides under the edge of the splint gently push the lower splint up and remove it To remove the upper splint gently push it down with both your index fingers and thumbs and remove it Using the bite tab When you remove the splint in the morning your bite may tem porarily 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 gt Important Always clean your appliance after each use Cleaning the appliance We recommend the following procedure for cleaning your Somno Dent oral sleep applicance e In the morning after removing the appliance rinse it under running water and clean it thoroughly with a toothbrush every day e Clean the titration screws on the left and right carefully with the included cleaning brush e After cleaning the SomnoDent oral sleep appliance dry it and store in the container e Keep the appliance and container away from direct sunlight e Use th
9. ure accuracy of fit comfort and durability It is warranted against manufacturing defects and mate rial 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 appliances Som noMed cannot guarantee that using a SomnoDent oral sleep appliance stops snoring and or alleviates obstruc tive sleep apnea because the conditions of each individual differ The warranty does not include e Adjustment of appliances after treatment that changes the shape of the teeth new crowns bridges e Corrections required as a result if incorrect bite impres sions e g protrusion too short or too long incorrect occlusal plane e Repairs required because of incorrect titration and use Warnings Contraindications Do not wear the appliance if any of the following are present e initial and advanced periodontitis e loose teeth e if you are under the age of 18 If you wear dentures please follow the instructions of your dentist regarding the use of SomnoDent oral sleep ap pliances Possible side effects Increased salivation when you start using the appliance is possible Wearing the appliance may cause temporary muscle tension muscle ache This should slowly diminish after removing the appliance If these side effects persist even after using the bite tab contact your dentist Long term us
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