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1. in order to achieve maximum comfort a customized dental mouthpiece may be required Read carefully the descriptive literature and consult with your healthcare professional concerning the two fitting procedures to determine which method is recommended for your needs CUSTOM FORMING YOUR BOIL N BITE MOUTH PIECE BRUSH TEETH BEFORE FORMING MOUTHPIECE 1 Prior to disassembling your CPAP PRO make note of the assembly so that you can reassemble properly after forming the mouthpiece Please note that the two corrugated tubes face towards your mouthpiece rather than outwards 2 Unscrew the dental mouthpiece bracket which is held in place by two white nylon screws Be sure to save the screws and nuts 3 Place the mouthpiece in a small pot and add enough water to cover the mouthpiece by at least two inches of water 4 Heat the water and mouthpiece so that the water comes to a rolling boil 5 Remove pot from heat 6 Place thermometer tip in water to determine water temperature 7 When the water cools and the thermometer reads 140F 150F or 60C 65C degrees carefully remove the mouthpiece with tongs 8 Shake off excess water 9 Make certain that the mouthpiece is not too hot to place in your mouth If you are sensitive to hot liquids or hot foods consult with your physician prior to proceeding Using a mirror quickly center the mouthpiece bracket directly under your nose and place the heated mouthpiece up agai
2. removed slide new diffuser over exhalation hole and gently press the nasal puff component into place NASAL PUFF DIFFUSER USER INFORMATION Intended Use The CPAP PRO CPAP interface is intended to treat adult obstructive sleep apnea OSA Description The CPAP PRO CPAP interface is a latex tree comfortable device for the treatment of adult obstructive sleep apnea OSA Individual nasal tubes are combined with a specially made dental appliance or a heat molded mouth piece depending on what your health care practitioner determines is best for your situation Both types will seal eftectively against each of your nostrils with the supplied soft synthetic nasal inserts The seal is not airtight however The system allows for the escape of some air as leakage helps eliminate trapped stagnant air that is exhaled back into the tubes while you are breathing Note The device is for single patient use The table below provides information about the performance of the CPAP PRO Your prescribing health practitioner will explain this information to you in detail it requested Table 1 shows how much dead space in ml or cc is in each CPAP PRO tube Vent leak rate in liters per minute is provided in Table 2 Leak rate is the amount of air that will flow through the vent holes Vent leak rate is important as it helps to flush out the dead space air The Table also shows how much dead space is contained in each nasal tube the part between t
3. the tubes and fittings for signs of cracks and splitting The tubing should be free of stains and discoloration Replace any parts of tubing if evidence of wear cracking staining or discoloration is noted REPLACING EXHALATION DIFFUSERS PART 7 A PLEASE NOTE The CPAP PRO nasal interface has been designed for maximum patient comfort and long term use In order to avoid damage it is essential that there be no undue strain pulling or kinking of the respiratory corrugated tubing Caution when replacing Exhalation Diffusers do not pull on tubing grasp diffusers to remove tubing from nasal puffs as illustrated on the next page The foam diffusers directly below the nasal puffs are extremely important for safe exhalation They must be kept clean and dry and should be replaced at least monthly Soaking the tubing in warm water prior to separating the nasal puffs from the tubing will make it much easier to separate the components The foam diffusers should be cleaned along with your CPAP PRO in warm water with some dishwashing liquid detergent Be sure to rinse your complete CPAP PRO in clear water In order not to damage the corrugated tubes Part 5 the nasal puff assembly should be gently removed from the corrugated tubing for green foam diffuser replacement by using a gentle rocking motion to separate the nasal puff from the tubing With pressure exerted only on the nasal puff and on the diffuser NOT THE TUBING When
4. DCC 13 214 Wh Wh STITI Ry Pi ie j PEM fa Hui Al MANS WN AARIN Way AN DA CPAP PRO PARTS DIAGRAM BIN AL PURE PART 2 2 DIRFOUSERS PART 7 3 MOUTHPIECE PART 1 4 HOSE CLAMPS PART 3 5 CURVED BRACKET PART 4 6 SCREW amp NUTS PART 8 7 CORRUGATED TUBES PART 5 8 Y COUPLING PART 6 PLEASE READ THIS INFORMATION CAREFULLY INTENDED USE The CPAP PRO CPAP interface is intended to treat adult obstructive sleep apnea OSA CAUTION In the USA federal law restricts this device to sale by or on order of a physician NOTE The CPAP PRO does not contain latex materials If you have ANY reaction to any part of the system discontinue use and consult your sleep therapist or physician A WARNING CPAP PRO should be used only with CPAP or bi level systems prescribed by your physician or respiratory therapist It should not be used unless the CPAP or bi level system is turned on and operating The exhalation ports and diffusers should never be blocked As part of this transaction we would like to make certain that you and our company CPAP PRO a division of Stevenson Industries Inc are in complete agreement with the terms of this sale No warranties are made or implied that you will find CPAP PRO to be more suitable for the treatment of your sleep apnea in comparison to cpap masks and other nasal devices that you may or may not have utilized since the comfort level of e
5. ach cpap breathing device is a matter of personal individual preference and cannot be predicted prior to actual use by the patient All information provided to you through any means of communication is for informational purposes only and is not a substitute for professional medical advice Only your healthcare provider should diagnose your healthcare problems and prescribe treatment All product information should be read thoroughly prior to purchase and use If you have or suspect you have a medical problem consult with your healthcare provider Your CPAP PRO kit includes data on two methods of forming a dental mouthpiece with a dental impression of your upper teeth The choice as to which method you choose to utilize is your sole decision based on your own and your physician s evaluation of your physical and emotional condition as well as your ability to understand the necessary procedural steps concerning the safety and instructions to properly form fit the dental mouthpiece If you have any serious problems whatsoever concerning the condition of your teeth gums or mouth such as but not limited to loose fillings removable bridges dentures sore gum problems or any other physiological problems such as TMJ or sensitivity to hot liquids or foods you should not utilize CPAP PRO without consulting with your physician or dentist to determine if CPAP PRO can safely be used by you During periodic visits to your dentist for evaluation pu
6. ater dental cleanser such as ACTIPRO DO NOT USE HOT WATER Rinse thoroughly It is not necessary to disassemble the CPAP PRO to clean the mouthpiece WEEKLY Separate and hand wash the components in warm soapy water Do not use soaps with added scents Rinse the components well and allow them to air dry out of direct sunlight A Caution It is essential that after cleaning the nasal puffs and the corrugated tubing are both perfectly dry If not the nasal puffs may slip off tubing A Caution Do not use solutions containing vinegar bleach chlorine aromatics moisturizers antibacterial agents or scented oils to clean any part of the system These solutions may cause damage and reduce the life of the product Do not expose any part of the system or tubing to direct sunlight as it may deteriorate the product If any visible deterioration of a component is apparent cracking tears etc the component should be discarded and replaced Wash your face before bedtime to eliminate slipping and sliding of the nasal puffs Do not use any creams or ointments on nostrils or nasal puffs Inspection and Replacement Proper care and usage should result in long trouble free utilization of your CPAP PRO However daily inspection and prompt replacement of any part showing wear or damage is required Upon receipt and before use carefully inspect all parts and tubing for visual defects and signs of wear or damage Check the ends of
7. ding them inward if necessary 23 PLEASE NOTE THAT IN ORDER TO KEEP THE NASAL PUFFS IN PLACE WITH THE NOSTRILS THE HOSE CLAMPS MUST BE POINTING TOWARDS ONE ANOTHER a mS AT NE pi AEN mam a iei LD b emi LUI aa A ni I mM HY 24 Connect to CPAP machine and evaluate CPAP PRO fitting If there is excess leakage the nasal puffs can be readjusted to apply more pressure to the nostrils If the nasal puffs spring outward from the nostrils adjust the hose clamps to a more extreme vertical angle ADDITIONAL SUGGESTIONS It will take several days or even weeks to get used to your CPAP PRO just as it does with other CPAP interfaces be patient and persevere SWIVEL CONNECTOR The Swivel Connector attaches to the Y Coupling Part 8 The Swivel Connector assists in connecting the CPAP PRO to CPAP tubing and helps prevent kinks in the CPAP hose This allows for additional comfort by increasing the ability to toss and turn trouble free This item is optional and not necessary for proper CPAP PRO use CLEANING INSTRUCTIONS DAILY Wash the CPAP PRO with warm soapy water Do not use soaps with added scents We recommend plain dishwashing liquid soap or baby shampoo Rinse well and allow to air dry out of direct sunlight Clean air outlet tips of Nasal Puffs Part 2 with alcohol Do not use alcohol on any other components Mouthpiece Clean nightly with only a cold w
8. g your CPAP PRO you get comfortable with having it in your mouth by wearing it while watching TV or reading the newspaper etc for a few hours daily Initially some patients accumulate an excess amount of saliva in their mouth With continued use this problem will end 18 Reconnect the mouthpiece to the curved bracket with the two corrugated tubes facing towards the mouthpiece Refer to the CPAP PRO Parts Diagram A CAUTION The corrugated respiratory tubes are designed for maximum patient comfort and many months of use Do not damage these tubes by pulling or kinking them ADJUSTING YOUR CPAP PRO FOR PERSONAL USE 19 Open the tube holder clamps Part 3 Hose Clamps by sliding one end upward and the other end downward A sample hose clamp is enclosed for practice TO OPEN CLAMP TO CLOSE CLAMP SLIDE ONE END UP AND THE OTHER END DOWN SQUEEZE TIGHTLY 20 While looking into a mirror with the mouthpiece affixed to your upper teeth gently slide the two corrugated tubes upward or downward to press the nasal puffs against the nostrils to form a good seal to prevent leakage 21 When the nasal puffs are in the proper position with your nostrils tightly squeeze the hose clamps to lock the corrugated tubes into position 22 For most patients having the two tube holder clamps in the extreme outward position of the curved bracket Part 4 is the most comfortable position however the hose clamps can be repositioned by sli
9. he tip of the nasal insert and the small vent holes in the tube Table 1 DEVICE APPROXIMATE DEAD SPACE CPAP PRO CPAP Less than 3 9ml Table 2 PRESSURE IN CM H20 CPAP PRO VENT LEAK IN L MIN 4 00 45 6 00 16 60 10 00 9 27 T500 28 57 18 00 129 Please take a few moments to review all of the instructions warnings and cautions before using CPAP PRO WARNING The CPAP PRO nasal cannula and connectors should only be used with CPAP systems recommended by your physician respiratory therapist or health care practitioner A nasal cannula should not be used unless the CPAP system is turned on and operating properly Ku Head der We siape Wo Disc curia Stevenson Industries Inc 780 Chambers Lane 200 Simi Valley CA 93065 USA Phone 800 538 8803 Fax 805 426 3551 Contents include 1 CPAP PRO 1 Manual Packet 1 Thermometer 1 Set Tubes with Diffusers 1 Swivel 1 Y Coupling 1 Set Diffusers
10. nst your upper teeth with front teeth as far forward as possible in mouthpiece i y d _ gt am EI N 10 With fingers and thumbs exert as much pressure as possible upwards to force your teeth firmly into impression material 11 Your teeth should actually touch the bottom of the mouthpiece tray Bite down firmly on the mouthpiece to form the impression 12 VERY IMPORTANT Do not remove the mouthpiece for approximately 5 minutes so that the filler material can cool down and solidify If you remove it too soon you will not have a good impression of your upper teeth and the mouthpiece will not stay affixed to your upper teeth 13 Gently remove the mouthpiece from your upper teeth 14 While the mouthpiece is still warm use small or rounded scissors to trim off the filler material Save trimmed filler material to use if you need to re form the mouthpiece IMPORTANT Do not trim the filler material that extends out the back of the tray around the last tooth simply flatten and smooth 15 Let your mouthpiece reach room temperature and harden You can speed the process by dipping it in ice water 16 Check the fit of your mouthpiece It should press comfortably onto your upper teeth and stay in place If it is too loose you can reheat the mouthpiece flatten out the filler material and redo the entire process 17 Now that you have made your mouthpiece we suggest that prior to reassemblin
11. rposes indicate that you are utilizing a dental appliances nightly If you experience any dental problems during the use of this product discontinue use immediately and consult with your dentist of sleep specialist It is possible to prepare the customized dental mouthpiece utilizing what is commonly known as the boil n bite method This will require your use of boiling water to soften the impression material and insertion of the heated mouthpiece into your mouth to press the softened filler material with sufficient pressure up against your upper teeth to make a dental impression of your teeth If you choose to utilize the boil n bite method utilizing boiling water please be aware that we assume no responsibility for any injury or damage that may occur due to the handling of these hot liquids and materials As an alternative to the boil n bite method there is a customized dental mouthpiece available using conventional dental impression procedures This procedure would be done by your dentist after an evaluation to determine if a customized mouthpiece is appropriate for you Please contact Stevenson Industries Inc to obtain information explaining the procedure and the necessary items for your dentist to utilize for this fitting procedure We offer no recommendation as to which fitting procedure would be best suited for your particular needs The boil n bite mouthpiece is designed to fit most patients however in some instances

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