ProSomnus MicrO 2 Sleep and Snore Device AND ProSomnus [IA] Sleep and Snore Device PATIENT INSTRUCTIONS FOR USE 1
ProSomnus Sleep Devices include the ProSomnus MicrO 2 Sleep and Snore Device and the ProSomnus [IA] Sleep and Snore Device with Monogram Customization options. All of the ProSomnus Devices use the same iterative advancement mechanism and follow the same indications for use. "This FDA accepted device complies with the requirements of directive 93/42/ EEC concerning medical devices. Caution: Federal (U.S.) law restricts this device to sale by, or on the order of, a dentist s prescription only." 2
ProSomnus MicrO 2 Sleep and Snore Device AND ProSomnus [IA] Sleep and Snore Device table of contents Important Safeguards... 5 Warnings... 6 Possible Side Effects... 8 Introduction... 10 Series Package Components...11 Parts Identification / Material Content... 13 Directions for Daily Use...16 Advancement Instructions...20 Homecare Instructions... 21 3
ProSomnus MicrO 2 Sleep and Snore Device AND ProSomnus [IA] Sleep and Snore Device 4
IMPORTANT SAFEGUARDS (Save these instructions) The following words in this manual have special significance: Warning: Means there is a possibility of injury to yourself or the device. Note: Indicates points of particular interest for more efficient use and convenient operation. Indications The ProSomnus Sleep Devices are intended to reduce night time snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults. You may have a fully embedded Compliance Sensor in your lower arch device. This Sensor does not affect the intended use for the treatment of mild to moderate OSA. The Sensor does not affect the care of the device. To learn more about the Sensor you have and how it works, please visit ProSomnus.com. Contraindications As with all jaw repositioning devices, this device is contraindicated for patients who have loose teeth, advanced periodontal disease, or lessened tooth stability due to orthodontic treatment. 5
Further, this device is contraindicated for patients having Central Sleep Apnea, or severe respiratory disorders. WARNINGS Note: Read all instructions before using your ProSomnus Sleep Device. 1. ProSomnus Sleep Devices are intended to reduce or alleviate snoring during sleep, and alleviate the symptoms of mild. to moderate Obstructive Sleep Apnea (OSA). If symptoms. of breathing difficulties or other respiratory disorders occur,. exist or persist, with or without the use of the device, you. should contact your prescribing dentist or medical physician. immediately. If wearing the device during this occurrence,. it is recommended to remove the device until you communicate with your prescriber. 2. ProSomnus Sleep Devices allow you to open your mouth and breathe during sleep, making it ideal for persons. 6
with upper airway constriction, due to function, anatomy, and sinus or allergy conditions. However, if you experience. obstruction of oral breathing, remove the device and contact. your prescriber. Note: You should return to the prescriber at least yearly, or as often as necessary, for evaluation of effective positioning, dental and bite evaluation, device fit, and material evaluation. If you experience any problems with your ProSomnus Sleep Device; becoming loose, damaged, or improper fit, contact your prescriber. 7
POSSIBLE SIDE EFFECTS As with all jaw repositioning devices, there are possible side effects associated with using ProSomnus Sleep Devices. These side effects are not common and can usually be remedied or managed together with the assistance of your prescriber. However, if left unattended or untreated, some side effects can become difficult to reverse or become permanent. If you experience any of the following side effects, you should contact your prescriber immediately. Slight tooth or gingival discomfort or movement due to pressure of the appliance. This can usually be adjusted by your prescribing dentist. Slight jaw soreness or tightness, both in the beginning and with each initial seating of the Upper series advancement devices. This is usually temporary, but if persists, contact your prescriber. Newly discovered bite change. Each morning your muscles need to resettle your jaw into your original closed 8
bite position. It is recommended to gently squeeze your back teeth together until your bite feels correct. This sensation should disappear within one hour each day. If it continues for more than four hours, you should contact your prescriber. o Left unattended, this could lead to permanent bite change. You may experience excessive salivation. This is normal for the first few weeks. If it persists, you should contact your prescriber. 9
PROSOMNUS MICRO 2 SLEEP AND SNORE DEVICE AND PROSOMNUS [IA] SLEEP AND SNORE DEVICE INTRODUCTION Your ProSomnus Sleep Devices are intended to reduce night time snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults by holding your lower jaw forward during sleep which prevents your tongue and throat tissues from collapsing into your airway. The ProSomnus Sleep Devices are patient specific to maximize tongue space and the ability to open and close during wear. You may have a fully embedded Compliance Sensor in your lower arch device. This Sensor does not affect the intended use for the treatment of mild to moderate OSA. The Sensor does not affect the care of the device. To learn more about the Sensor you have and how it works, please visit ProSomnus.com. The ProSomnus Device series of arch forms are designed to match the advancement positions your dentist has prescribed. Jaw advancements are easily achieved by simply removing your current Upper or Lower Arches and inserting the next Upper or Lower Arch in the ProSomnus Sleep Device series. Your dentist prescribes the amount of advancement increments according to your treatment plan. The ProSomnus Sleep Devices are simple to use, comfortable to wear, and easy to keep clean. These devices are patient-specific for single-patient use. ProSomnus Sleep Devices are intended to be worn during sleep by adults 18 years or older. 10
EACH PROSOMNUS MICRO 2 SLEEP AND SNORE DEVICE AND PROSOMNUS [IA] SLEEP AND SNORE DEVICE PACKAGE CONTAINS: 1 or more Lower Arch devices Easily identified by inscribed (L) 1 or more Upper Arch devices Easily identified by inscribed (U) Upper and Lower devices will have the advancement measurement labeled on the sides o The initial Upper and Lower devices will be inserted with a zero (0), reflecting the initial position of the prescribed lower jaw repositioning bite. o Additional series devices will be included per dentist prescription. These will be inserted with a number that reflects the prescribed advancement positions in (mm) increments and in relation to the initial bite position. Instructions for use Storage case(s) 11
Series A UO LO PROSOMNUS MICRO 2 SLEEP AND SNORE DEVICE SERIES AND PROSOMNUS [IA] SLEEP AND SNORE DEVICE SERIES (EXAMPLE ONLY) The ProSomnus Device series includes an Initial (0) Set of upper and lower arch devices precisely positioned at the bite registration provided by your dentist, together with an additional Advancement Set of upper and lower devices made according to the advancement measurements selected by your dentist. Your dentist may prescribe two or more advancement devices, based on your specific needs. Advancement amount can be easily seen on the side of the repositioning posts. 12
COMPONENT PARTS IDENTIFICATION / MATERIAL CONTENT OF THE PROSOMNUS MICRO 2 SLEEP AND SNORE DEVICE AND THE PROSOMNUS [IA] SLEEP AND SNORE DEVICE Note: This device is entirely made of medical grade material. If you experience any reaction, contact your prescriber immediately. Note: Your device may also include stainless steel clasps or other wire components to aid in a secure fit, not shown. If you experience any reaction, contact your prescriber immediately. Your device may also contain a Compliance Sensor on the Lower Zero Arch (not shown). The Compliance Sensor logs the time and date that the ProSomnus Sleep Device is worn in the mouth. 13
Part # Part / Component Name 1 Upper intaglio surface 2 Upper lingual surface 3 Upper facial main body 4 Upper unique device identifier (UDI) code 5 Visual Arch ID / Iteration Advancement ID 6 Upper left mating post 7 Lower left mating post 8 Visual Arch ID / Iteration Advancement ID 9 Lower unique device identifier (UDI) code 10 Lower facial main body 11 Upper occlusal table 14
12 Lower lingual surface 13 Lower occlusal table 14 Lower right mating post 15 Upper right mating post Material Content: Polymethylmethacrylate (PMMA). Added Wire Components: Stainless Steel, contains Nickel and Chromium. Hazardous Substances at or below NIOSH. Recommended Exposure Limits. 15
DIRECTIONS FOR DAILY USE OF THE PROSOMNUS MICRO 2 SLEEP AND SNORE DEVICE AND THE PROSOMNUS [IA] SLEEP AND SNORE DEVICE 1. Do not insert until just prior to sleep. 2. Inspect the device prior to each use. Contact your prescriber if you observe any material degradation or cracks. 3. Rinse with water before use. Always brush your teeth and floss well before inserting the ProSomnus Device into your mouth. 4. Select the correct arch devices: Lower Arch device (L) Upper Arch device (U) Upper and Lower devices will have the advancement label on the left posts. o The initial Upper and Lower devices will each be marked. and inserted with a zero (0), reflecting the initial position. of prescribed repositioning bite. 16
o Additional series devices will be included per the dentist prescription. These will be inserted with a number that reflects the prescribed advancement positions in (mm) increments, and in relation to the initial bite position. 5. Place the Upper and Lower devices together as one device.. Ensure the lower posts are in front of the upper posts (as shown on page 12). 6. Alternatively insert the devices separately. First, insert your Upper Arch: Use your thumbs and forefingers to push the Upper Arch device (U) securely onto your upper teeth. Note: Be sure you have the correct advancement arch. 7. Second, insert your Lower Arch: Open wide and repeat the same process to push the Lower Arch device (L) onto your lower teeth. DO NOT CLOSE without moving your lower jaw forward. Move your lower jaw forward, then close slowly. The Lower Arch posts pointing upward belong in front of the Upper Arch posts that are pointing downward. 8. Gently relax your jaw and settle down for a restful night. 17
9. To remove the device, first remove the lower arch. Gently. open your mouth and place your thumbs into your cheek areas below the fin on both sides of the device. 10. Apply even, upward pressure at the side edges of the device to lift out and remove. 11. Repeat the same process for the upper arch by applying downward pressure, using your index fingers. Note: Do not remove one-handed, this will place unnecessary torque on the device frame and can cause breakage. 18
Warning: The individual arches of the ProSomnus Devices should never be worn separately. Always wear both Upper and Lower devices together. Warning: Store out of reach of small children. Note: Dogs are attracted to the smell of oral devices. Keep out of reach of dogs. 19
ADVANCING THE LOWER JAW OF THE PROSOMNUS MICRO 2 SLEEP AND SNORE DEVICE AND THE PROSOMNUS [IA] SLEEP AND SNORE DEVICE The ProSomnus Device series of arch forms are designed to match the advancement positions your dentist has prescribed. Jaw advancements are easily achieved by simply removing your current Upper or Lower device and inserting the next Upper or Lower device in the ProSomnus Device series. The ProSomnus Devices are simple to use, comfortable to wear, and easy to keep clean. Note: If you have been provided with multiple repositioning Upper or Lower devices, your prescribing dentist should direct you when to advance to the next device in the series. 20
HOMECARE INSTRUCTIONS Note: Sterilization is not required for this device. Daily: 1. Each morning after use, thoroughly clean your ProSomnus Devices using a regular soft toothbrush, cool or warm water and mild detergent, such as orthodontic device cleaners, or antibacterial liquid soaps. Do not use denture cleaners, as they may be too harsh. Warning: Do not clean the appliance in hot or boiling water. This can cause the resin material to warp. 2. Rinse thoroughly and dry your appliance completely before storing in the container. It may help to leave the container open to ensure that your devices dry thoroughly. 3. Daily soaking of your devices is not necessary, nor recommended. 21
Note: Water can etch the surface of resin and leave mineral deposits. Mouthwash or concentrated bleach solutions can permeate the resin material, and your device can absorb the odors from cleaning solutions. Weekly: You may use an ultrasonic cleaner with these devices, following the instructions on the previous page. Storage: ALWAYS keep out of reach of small children and pets. Warning: ProSomnus Devices should be stored in a cool, dry place. The appliance is made from resin materials that should not be stored where temperatures exceed 100 F, such as in cars, direct sunlight, etc. 22
ProSomnus MicrO 2 Sleep and Snore Device ProSomnus [IA] Monogram Sleep and Snore Device iterative advancement ProSomnus and MicrO 2 are Registered Trademarks. U.S. Patent No. 9,820,882 U.S. Patent No. 9,808,327 PRO3-008-B (January 2018) 23
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