aveoTSD User Manual
Contents
1. require more practice and sometimes professional or medical assistance Innovative Health Technologies New Zea land Ltd cannot therefore warranty com pliance usage issues Usage is a personal matter in ensuring the device works prop erly Innovative Health Technologies New Zea land Ltd has an ongoing post development support program to improve the product The program also aims to improve correct usage compliance through instructions to health professionals and users Further user support will be obtained from professional and user feedback as product usage wid ens The aveoTSD product life has not yet been established but 12 months use should be a minimum provided proper care is given to the device Users should follow instructions in this booklet and are advised to seek early advice and or treatment if problems arise 15 Frequently Asked Questions What causes snoring Snoring is caused by a narrowed airway during sleep This can be due to large tonsils or a long soft palate or uvula Overweight people who have excessive flabby tissue in the throat also experience snoring All of these areas relax during sleep In other cases nasal congestion from allergies or deformi ties of the cartilage between the two sides of the nose can contribute to narrowing of the airway However the most common cause of a narrowed airway is a tongue muscle that becomes too relaxed during sleep and gets sucked back into2. aveo anti snoring aid User Manual P aveo SD User Manual Contents introd cing the aveo TSD sicicususieeiagusssu netic arwodaemasaiaeusivenaesusdeusucusasevtinaiuacedsdesaddeavelilnatimmonnccaes 1 How aveo TSD WOKS siscsitsnctictianiundiraldcaddaiaiientusabdenunlasieiianteunniscdaddniemedaunbnateadladosadenauiniscnsinis 2 aveo TSD User MISIMUCTON S snainiincudsssiciets neat cisncheaidandusisntutincdsaicnmed aia iiia E arada 4 Extra Support in Using the aveoTSD sincasesssctessiininadidenrenacctnchoniveldeadeusiad alacadelvesacasuiaddbaaivescasnes 8 Issues Solutions and Support Chart crvessiswadesneivnss tas rmcswecaiiddsnaseuasmasnicnaceanadissanedesadmecismasects 10 aveo ToO Side ENEO S eiiean n eaea eaae aia 12 aveoTSD Care and Cleaning aia cciaasinesnischaioe acest outa nila saci icancdevudeatieruwen dcucudeaudvatateburseemendesusant 13 WUE UY E E E IEA EA E T A A A 14 Frequently Asked Questions cccecccceceeeeeeseeeeeenessceceeeesaasseeeeeeseauseeeeeessaaseeeeeessaaseeeeesenees 15 Common Causes and Health Consequences of Snoring ccsccccessesseeeeeeeeensseeeeeesneaaees 17 aveoTSD Development History vcccasssstateseswinsncancauatastwedebadndcawawedasiersuadisucuieundeabieburstenriedaratte 19 Introducing the aveol SD Tongue Stabilizing Device The aveoTSD anti snoring aid was developed after several years of clinical research on the treatment of problem snoring Unlike traditional mandibular advancement devices th
3. e aveoTSD does not attach to the teeth and does not require fitting by a dentist or dental sleep specialist The aveoTSD is cost effective and easy to use For many patients it will eliminate or greatly reduce problem snoring making it an effective anti snoring treatment Without aveolISD TONGUE Tongue falls to back of throat during sleep In this MRI image the tongue falls to the back of the throat as a person sleeps This blocks the airway leading to snoring BLOCKED AIRWAY With aveoT SD l aveo I SD This MRI image shows the aveoTSD hold ing the tongue gently forward preventing it from falling back and obstructing the airway TONGUE Note how the airway is now open and clear This stops or greatly reduces snoring aveo SD User Instructions The aveoTSD is a medical device used to treat problem snoring It requires correct fitting so it can be used in the most comfortable manner Carefully read the following instructions to ensure the best possible results from the aveoTSD anti snoring aid N The tongue is free moving and can eas ily change size shape and position It is un The V notch likely you will damage your tongue with the ee fits around the aveoTSD device lingual frenulum lt f which holds The aveoTSD is available in the U S by pre the tongue to scription from a dentist or medical physician the floor of the mouth aveo l SD User Instructions 1 Rinse the aveoTSD under hot
4. e medical silicone used to manufacture the aveoTSD The aveoTSD can be sterilized with cold sterilant or clinical procedures such as au toclave Once a week give your aveoTSD a thor ough wash then rinse Use denture clean ing solution to give it a weekly or monthly wash for long term use To release seal of container Squeeze sides Ease apart Remove device 13 Warranty Innovative Health Technologies New Zea land Ltd will provide a six month replace ment warranty from the date of purchase for product defects determined to be caused by the manufacturer The aveoTSD is a medical device used to treat problem snoring See Frequently Asked Questions on p 17 for more informa tion The device is clinically proven and has regu latory approvals to be marketed as a Class 1 medical device in Australia Canada EEC 14 Hong Kong Japan New Zealand USA and other countries Patents have been granted in those countries The aveoTSD can be prescribed to patients via a dentist or medical physician who can also advise on problem snoring and its po tentially serious health consequences This advice may also include a visual anatomical check to ensure the device fits properly Users of the aveoTSD need one to three days occasionally more than two weeks to achieve compliance Warranty Practice and perseverance is needed for all medical devices Some people are able to adapt to their use quickly others
5. ice stays on Extra Support in Using the aveoI SD and you get a good night s sleep Salivating While awake we swallow fre quently When asleep we swallow much less When something is placed between the jaws salivation is a normal response Some people may salivate excessively with initial usage of the aveoTSD but this side effect will reduce within a week or so of con tinued use My tongue has strong sensations Ad just the aveoTSD by either withdrawing the tongue slightly or reducing the suction a little see User Instructions Tilt or twist the device while it has suction OR move the aveoTSD slightly forward on the tongue Tongue tied users should consult their doc tors to check whether minor procedure could free the tongue This condition is very rare have difficulty swallowing and a gag ging sensation along with salivating You may have your tongue extended too far Move the unit back off the tongue slightly to give the tongue a little more flexibility Always discuss any problems with your pri mary health care provider or dentist aveol SD Issues Solutions and Support Chart A Can use but aveoTSD comes off during night gt Continue using the device Practice will improve Too little suction Move tongue farther into device to create skill more suction Continued usage will reduce falling off within Experienced by less than 20 of users a few weeks B Can use but aveoTSD creates sen
6. ill be more difficult ging feeling Experienced by less than 5 of users F Physical changes to aveoTSD gt Refer to Care and Cleaning If the device smells it may not be properly cleaned or a dental check Experienced by less than 0 01 of users may be needed If device looks different ensure you are not using mouth wash or an alcohol based cleaning agent which can damage the device G Tongue has changed color gt Others have also experienced this It is im This is linked to B on the previous page Reduce suction pressure on portant to realize that in most cases these tongue by gently squeezing the aveoTSD and moving tongue slightly symptoms are caused by the use of medi out of the device cation for treatment of high blood pressure or cholesterol Experienced by less than 0 01 of users aveol SD Side Effects No moderate or serious side effects have been reported Reported side effects are tempo rary and occur only during initial practice and use Refer to Issues Solutions and Support Chart if you have difficulty with initial usage During initial usage should discomfort or other perceived side effects occur stop using the aveoTSD until the cause is established Seek medical attention or review practice steps to correctly fit the device 12 aveo SD Care and Cleaning Keep the aveoTSD clean by rinsing it dai ly in hot water Do not use mouthwash to clean or store the device because alcohol will damage th
7. ls Snoring is also commonly experienced by women during the latter stages of pregnancy 18 aveo l SD Development History We spend one third of our lives asleep and the quality of that sleep has a real impact on our quality of life Problem snoring can be treated but until now a treatment that is simple to use non invasive and cost effective was not avail able The aveoTSD was developed over several years with the last few years being spent developing the current model designed by Dr Chris Robertson of New Zealand Dr Robertson is an internationally recog nized researcher in the field of Dental Sleep Medicine Aveo is Latin for be well Quality of sleep and sleep medicine are relatively new areas within health care with a growing awareness of the serious health consequences of problem snoring It is now recognized that snoring is a health warning and the ability to diagnose and treat sleep related problems associated with snoring means many people now have a greatly enhanced quality of life 19 Australia aveotsd com au Austria aveosleep eu Canada aveosleep ca Germany aveosleep eu Ireland tlcperformance org Japan aveotsd com New Zealand aveotsd co nz Qatar innomed intl com Switzerland aveosleep eu The Netherlands stoppenmetsnurken nl United Kingdom aveosleep co uk United States getaveo com aveol SD anti snoring aid is a registered trademark of I
8. nnovative Health Technologies NZ Limited Australian Patent No AU776822 Canadian Patent No CA2432023 European Patent No EPI349521 Japanese Patent No JP544615 2001 Hong Kong Patent No HK1060041 New Zealand Patent No NZ526404 United States of America Patent No US7073506 International Patents Pending Innovative Health Technologies NZ Limited aveotsd com aveotsd aveosleep com Registered Office HGW Health Board House 229 Moray Place Dunedin New Zealand PO Box 17572 Christchurch New Zealand Copyright 2010 Innovative Health Technologies NZ Limited ry A clinically proven medical ave ol S device for the treatment of anti snoring aid problem snoring The aveoTSD is made from soft medical grade silicone and works by holding the tongue forward using gentle suction pre venting it from falling back into the throat Contents 1 Device and blocking the airway during sleep 1 Storage Container 1 User Manual Glidewell Laboratories 4141 MacArthur Blvd Newport Beach CA 92660 800 334 1979 getaveo com 9427190006701 5 GL 2281 0810
9. onsils long soft palate or uvula e Being overweight A recent study showed that a 10 per cent weight gain may lead to a six fold increase in the likelihood of developing habitual problem snoring e Nasal congestion from colds allergies or deformities of cartilage in the nose e Smoking alcohol or medication which causes drowsi ness e Hypothyroidism Due to a lack of thyroid hormones suf ferers tend to have a large tongue as well as increased fat deposits in the tissue of the upper airway e Menopause Post menopausal women were shown to have more than twice the risk of problem snoring Snoring has been linked to an increased risk of e High blood pressure e Cardiovascular disorders e Depression e Impotence e Reflux and heartburn e Obesity e Diabetes e Strokes e Memory problems vi How many people suffer from problem snoring More than 60 percent of the adult population suffers from problem snoring particularly those aged 50 and older As people age the tissue in the upper airway loses its elasticity and tends to vibrate more during breathing increasing the incidence of snoring When the airway is reduced during sleep the tongue is more easily sucked into the back of the throat and obstructs the airway At least 60 percent of men and 40 percent of women over the age of 40 snore Snoring is also quite common in children between the age of 2 and 7 particularly if they have a chest infection or enlarged tonsi
10. sation on tongue gt Continue using the device Practice will improve Too much suction Reduce suction and move tongue slightly skill out Sensation will diminish or disappear as tongue becomes Experienced by less than 15 of users accustomed to the device C Have problems fitting aveoTSD under tongue gt Do not use the device for three days Then try Check on lingual frenulum and tongue tied status with again making sure the device is not irritating the your doctor A simple procedure can correct this issue lingual frenulum under the tongue and that it feels comfortable If there are also B symptoms stop using the device for three days then try again Experienced by less than 15 of users Tongue tie occurs in less than 0 06 of users 10 aveol SD Issues Solutions and Support Chart D Increased salivation gt Persevere Some people create more sa Most users will experience this initially because salivating is automatic liva than others After a week or so the brain recognizes the device is not food and stops Experienced by 80 95 of users salivating E Cannot swallow with device in place and saliva builds up gt Ease aveolSD off tongue slightly so Swallowing during sleep happens far less often than when we are that some flexibility returns to the tongue awake With the device in the mouth saliva builds up If the tongue When salivation reduces so will the gag is too stretched it is less flexible so swallowing w
11. the throat with each breath taken refer to MRI images Snoring occurs because air travels faster through a narrow tube than through a broad one This rapidly moving air causes the relaxed soft tis sues of the throat tonsils soft palate uvula or excessive flabby tissue to vibrate It is this vibration that creates the sound of snoring By keeping the airway open air travels more slowly reducing throat vibrations and thus reduc 16 ing or stopping snoring One of the most effective ways of keeping the airway open during sleep is by holding the tongue forward Is snoring harmful New research suggests that problem snoring can cause hypertension and as a result increased blood pressure during sleep This airway obstruction causes the heart rate to fall below normal with decreases in blood oxygen levels The ob struction will not clear until the brain s oxygen level falls low enough to partly wake the sleeper with a release of adrenaline This is an automatic body reaction intended to prevent suffocation The airway obstruction is usually broken with one or sev eral often loud gasps to take in fresh air Due to the adrena line release the heart rate is increased above normal This event may happen hundreds of times a night for someone suffering from problem snoring which means the sleeper does not get a deep restorative sleep Most common causes of snoring e A tongue that becomes too relaxed during sleep e Large t
12. vice press in on the sides to break suction If you prefer squeeze the bulb with your thumb on the bottom and forefinger on the top 7 After use thoroughly clean and rinse the aveoTSD with hot water Store in the con tainer provided Do not rinse or store the device in mouthwash or any other chemi cal product that contains alcohol because this may damage the medical silicone Extra Support in Using the aveol SD Some people will be able to use the aveoTSD comfortably within a couple of days However for most patients it takes one to two weeks for discomfort to disap pear Perseverance with the aveoTSD will be rewarded As you achieve compliance it is likely there will be a reduction in sudden awakenings or gasping for air during sleep This will mean a good night s rest giving you more energy through the day and a feeling of improved well being The aveoTSD will also provide less distur 8 bance for your partner However it is pos sible because of anatomical features and or other health related problems that some people may have difficulty using this de vice If you are unable to use the aveoTSD or symptoms persist please contact your primary health care provider or dentist for further consultation For some people perseverance and pa tience is needed particularly for suction control This skill will be learned over time My aveoTSD falls off Adjust the aveoTSD onto the tongue until the dev
13. water This helps to ease the device onto the patient s tongue Make sure the V notch is facing down as shown in the illustra tion below Place on the outside of the lips 2 Push tongue gently into the aveoTSD un til it touches the sides of the device l 3 Gently squeeze the upper and lower X ends of the bulb between the forefinger Notch f 5 aveo l SD User Instructions and thumb Note the changes in suc tion created By using a gentle repeated pumping action the tongue will be drawn gently into the device Make sure the de vice is not too tight or too loose This is important too much suction will cause discomfort not enough suction will cause the aveoTSD to fall off during the night Practice until the device is held firmly and comfortably Initially keep the aveoTSD on your tongue for about 10 minutes at a time adjusting it by increasing or reducing suction to find the most comfortable fit This will ensure you are not push ing on the lingual frenulum which holds the tongue to the floor of the mouth Note Use of the aveoTSD may initially cause discomfort however this will sub aveo SD User Instructions side Experiment with the device to find the position and suction pressure most comfortable for you Suction the aveoTSD to the tongue in an agreeable position before going to sleep Initially it is easier to fit the device while sitting or standing To remove the de
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