ProSomnus Sleep and Snore Devices PATIENT INSTRUCTIONS FOR USE

Transcription

1 ProSomnus Sleep and Snore Devices PATIENT INSTRUCTIONS FOR USE 1

2 table of contents Introduction... 4 Warnings Possible Side Effects Series Package Components: MicrO 2 & [IA] Parts Identification / Material Content: MicrO 2 & [IA] Series Package Components: [CA] Parts Identification / Material Content: [CA] Directions for Daily Use Advancement Instructions: MicrO 2 & [IA] Advancement Instructions: [CA] Homecare Instructions ProSomnus Sleep and Snore Devices include the ProSomnus MicrO 2 Sleep and Snore Device, the ProSomnus [IA] Sleep and Snore Device with Monogram Customization Options and the ProSomnus [CA] Sleep and Snore Device. These devices will also be referred to as the ProSomnus Sleep Devices. These FDA accepted devices comply 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

3 ProSomnus MicrO 2 Sleep and Snore Device ProSomnus [IA] Sleep and Snore Device with Monogram Customization ProSomnus [CA] Sleep and Snore Device 3

4 PROSOMNUS SLEEP AND SNORE DEVICES 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. 4

5 If you have a ProSomnus [CA] Sleep and Snore Device, it can easily be adjusted to the advancement positions your dentist has prescribed, by simply adjusting the expansion screws on the Upper Arch per your dentist s instructions. See pages for details. 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. IMPORTANT SAFEGUARDS 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. 5

6 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, these devices are contraindicated for patients who have loose teeth, advanced periodontal disease, or lessened tooth stability due to orthodontic treatment. Further, these devices are contraindicated for patients having Central Sleep Apnea, or severe respiratory disorders. 6

7 WARNINGS Device Warnings Note: Read all instructions before using your ProSomnus Sleep Devices. 1. 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 iediately. If wearing the device during this occurrence, it is recoended to remove the device until you counicate with your prescriber. 2. You may experience excessive salivation. This is normal for the first few weeks, but if it persists, you should contact your prescriber. 3. You may experience soreness or discomfort in your jaw, inside cheeks or teeth. If discomfort persists, discontinue wearing the device and contact your prescriber. 4. You may feel a change in your bite in the morning. It is recoended to gently squeeze your back teeth together until your bite feels correct. This sensation should disappear 7

8 within one hour, each day. If it continues for more than four hours, you should contact the prescriber. 5. The ProSomnus Sleep Devices allow you to open your mouth and breathe during sleep. 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 Devices; becoming loose, damaged, or improper fit, contact your prescriber. 8

9 POSSIBLE SIDE EFFECTS As with all jaw repositioning devices, there are possible side effects associated with using the ProSomnus Sleep Devices. These side effects are not coon 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 iediately. Slight tooth or gingival discomfort or movement due to pressure of the device. 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 bite position. It is recoended to gently squeeze your back teeth together until your bite feels correct. This 9

10 10 sensation should disappear within one hour each day. If it continues for more than four hours, you should contact your prescriber. - Left unattended, this could lead to permanent bite change. Device falling out or you may unconsciously take the device out of your mouth during the night. Movement of teeth. Pain in the jaw joint. Permanent bite change.

11 EACH PROSOMNUS MICRO 2 AND [IA] SLEEP AND SNORE DEVICE PACKAGE CONTAINS: 1 or more Lower Arch devices Identified by inscribed (L) 1 or more Upper Arch devices Identified by inscribed (U) Upper and Lower devices will have the advancement measurement labeled on the sides The initial Upper and Lower devices will be inserted with a zero (0), reflecting the initial position of the prescribed lower jaw repositioning bite. Additional series devices will be included per dentist prescription. These will be marked with a number that reflects the prescribed advancement positions in () increments and in relation to the initial bite position. Instructions for use Storage case(s) 11

12 PROSOMNUS MICRO 2 AND [IA] SLEEP AND SNORE DEVICE SERIES (EXAMPLE ONLY) The ProSomnus MicrO 2 and [IA] Sleep and Snore Device Series includes an Initial (0) Set of Upper and Lower Arches precisely positioned at the bite registration provided by your dentist, together with an additional Advancement Set of Upper and Lower Arches made according to the advancement measurements selected by your dentist. Your dentist may prescribe two or more advancement arches, based on your specific needs. Advancement amount can be easily seen on the side of the repositioning posts. Series A UO LO 12

13 COMPONENT PARTS IDENTIFICATION / MATERIAL CONTENT OF THE PROSOMNUS MICRO 2 AND [IA] SLEEP AND SNORE DEVICE Note: This device is entirely made of medical grade material. If you experience any reaction, contact your prescriber iediately. 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 iediately. 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. Your 13

14 dentist will request that you bring your appliance in periodically to read the log and create a compliance report. This sensor does not affect the use and care of the ProSomnus Sleep Device, follow instructions in this guide and your doctor. For more information about the Compliance Sensor, visit ProSomnus.com. 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

15 12 Lower lingual surface 13 Lower occlusal table 14 Lower right mating post 15 Upper right mating post Material Content: Polymethylmethacrylate (PMMA) with high molecular weight Methylmethacrylate. Ball Clasps: Medical Grade Stainless Steel, contains Nickel and Chromium. Hazardous Substances at or below NIOSH Recoended Exposure Limits. 15

16 EACH PROSOMNUS [CA] SLEEP AND SNORE DEVICE PACKAGE CONTAINS: 1 Upper [CA] Arch with Expansion Screws 1 Lower Arch Identified by inscribed (L0) Lower Arch will also have an inscribed number (e.g. L5) Instructions for use Storage case(s) 16

17 PROSOMNUS [CA] SLEEP AND SNORE DEVICE SERIES (EXAMPLE ONLY) The ProSomnus [CA] Sleep and Snore Device includes 1 Upper [CA] Arch with Expansion Screws, and 1 Lower Arch precisely positioned at the bite registration provided by your Dentist. 17

18 COMPONENT PARTS IDENTIFICATION / MATERIAL CONTENT OF THE PROSOMNUS [CA] SLEEP AND SNORE DEVICE Note: This device is made of medical grade material and includes an Expansion Screw composed of medical grade stainless steel. 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 iediately. 18

19 Part # Part / Component Name 1 Upper intaglio surface 2 Upper lingual surface 3 Upper facial main body 4 Upper unique device identifier (UDI) 5 Upper left mating post with expansion screw 6 Lower left mating post 7 Visual arch ID / Iteration advancement ID 8 Lower unique device identifier (UDI) 9 Upper occlusal table 10 Lower lingual surface 11 Lower facial main body 19

20 12 Lower occlusal table 13 Lower right mating post 14 Upper right mating post with expansion screw Material Content: Polymethylmethacrylate (PMMA) with high molecular weight Methylmethacrylate. Ball Clasps: Medical Grade Stainless Steel, contains Nickel and Chromium. Hazardous Substances at or below NIOSH Recoended Exposure Limits. Expansion Screws: Medical Grade Stainless Steel. 20

21 DIRECTIONS FOR DAILY USE OF THE PROSOMNUS SLEEP DEVICES 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 arches: For the ProSomnus MicrO 2 and [IA] Sleep and Snore Devices a. Lower Arch (L) b. Upper Arch (U) c. Upper and Lower Arches will have the advancement. label on the left posts. i. The initial Upper and Lower Arches will each be marked with a Zero (0), reflecting the initial position of prescribed repositioning bite. 21

22 For the ProSomnus [CA] Sleep and Snore Device a. Lower Arch (L0) b. Upper Arch with Expansion Screws c. Lower arches will have the advancement label on the left posts. i. The initial Lower arches will be marked with a Zero (0), reflecting the initial position of prescribed repositioning bite. ii. The Upper Expansion Screw is set at 0.0 which represents your initial bite position. 5. Place the Upper and Lower Arches together as one device. Ensure the lower posts are in front of the upper posts. Place into the mouth and seat the device on to your teeth. (as shown on page 12 for MicrO 2 and [IA] and page 17 for [CA]). 6. Alternatively insert the arches separately. First, insert your. Upper Arch: a. Use your thumbs and forefingers to push the Upper Arch securely onto your upper teeth. 22

23 7. Second, insert your Lower Arch: a. Open wide and repeat the same process to push the Lower Arch (L) on to 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. 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 arch frame and can cause breakage. 23

24 Warning: The individual arches of the ProSomnus Devices should never be worn separately. Always wear both Upper and Lower arches 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. ADVANCING THE LOWER JAW USING THE PROSOMNUS MICRO 2 AND [IA] SLEEP AND SNORE DEVICES The ProSomnus Sleep 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 Arch and inserting the next Upper or Lower Arch in the ProSomnus Device series. 24

25 Note: If you have been provided with multiple repositioning Upper or Lower arches, your prescribing dentist should direct you when to advance to the next device in the series. ADVANCING THE LOWER JAW USING THE PROSOMNUS [CA] SLEEP AND SNORE DEVICE ProSomnus Sleep Device series of arch forms are designed to match the advancement positions your dentist has prescribed. Jaw advancements are easily achieved by simply adjusting the Expansion Screw by using the tool provided. Pay attention to the arrows on the side of the Expansion Screw. These tell you the direction to turn the screw to advance the post. Each 90 turn is 0.1. Note: If you have been provided with multiple repositioning Upper or Lower Arches, your prescribing dentist should direct you when to advance to the next device in the series. 25

26 PROSOMNUS [CA] FORWARD ADJUSTMENT Hold upper tray with expansion screw facing you. Locate yellow reference arrow on device. Fit the expansion tool into the adjustment keyhole IMPORTANT! Rotate the expansion tool 90 o in the direction of the arrow to advance forward. 26 Count your turns and repeat adjustments on both sides.

27 PROSOMNUS [CA] BACKWARD ADJUSTMENT Hold upper tray with expansion screw facing you. Fit the expansion tool into the adjustment keyhole IMPORTANT! Rotate the expansion tool 90 o toward you. Count your turns and repeat adjustments on both sides. 27

28 PROSOMNUS [CA] ADVANCEMENT GUIDE Starting Position +5.0 ProSomnus [CA] Standard, (Upper [CA] Arch + Lower 0 Arch) 28 Reverse (90 o Screw Turns) Bite Starting Position Forward (90 o Screw Turns) 90 o Screw Turns Expansion Screw Adj. () ProSomnus [CA] with Additional Lower Advancement Arch, (Upper [CA] Arch + Lower +5.0 Arch) Expansion screw reset position Forward (90 o Screw Turns) 90 o Screw Turns Expansion Screw Adj. () Note: Your ProSomnus [CA] Sleep and Snore Device can be adjusted within a 12.0 total titration range. Your Dentist will instruct you on the number of 90 screw turns to make based on comfort and symptom reduction. Your Dentist may provide you with an additional Lower Arch to achieve the full range. Resetting Upper Post: Turn screw on Upper [CA] Arch 90 in the opposite direction to move post to the back of the arch

29 PROSOMNUS [CA] ADVANCEMENT MARKINGS Device Starting Position (Raised bumps on device provide reference for advancement location) 29

30 HOMECARE INSTRUCTIONS Note: Sterilization is not required for this device. Daily: 1. Each morning after use, thoroughly clean your ProSomnus Sleep Device 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 PMMA 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 recoended. Note: Water can etch the surface of the PMMA and leave mineral deposits. Mouthwash or concentrated bleach solutions can permeate the PMMA material. 30

31 Storage: ALWAYS keep out of reach of small children and pets. Warning: The ProSomnus Sleep Device should be stored in a cool, dry place. The device is made from materials that should not be stored where temperatures exceed 100 F, such as in cars, direct sunlight, etc. Warning: The ProSomnus Sleep Devices are FDA cleared medical devices. You must not tamper with it other than following the specific instructions in this booklet. 31

32 ProSomnus MicrO 2 Sleep and Snore Device Storage temperature range. Consult physician operating instructions. Patient-specific Dental Device Sterilization Not Required Unique Device Identifier imprinted directly on device ProSomnus Sleep Technologies 5860 West Las Positas Blvd. Suite 25 Pleasanton, CA ProSomnus.com PRO3-006-A 32

33 ProSomnus [IA] Monogram Sleep and Snore Device ITERATIVE ADVANCEMENT Storage temperature range. Consult physician operating instructions. Patient-specific Dental Device Sterilization Not Required Unique Device Identifier imprinted directly on device ProSomnus Sleep Technologies 5860 West Las Positas Blvd. Suite 25 Pleasanton, CA ProSomnus.com PRO3-007-A 33

34 ProSomnus [CA] Sleep and Snore Device CONTINUOUS ADVANCEMENT Storage temperature range. Consult physician operating instructions. Patient-specific Dental Device Sterilization Not Required Unique Device Identifier imprinted directly on device ProSomnus Sleep Technologies 5860 West Las Positas Blvd. Suite 25 Pleasanton, CA ProSomnus.com PRO3-029-B 34

35 MANUFACTURED BY PROSOMNUS SLEEP TECHNOLOGIES. Made in California USA / ProSomnus.com ProSomnus and MicrO 2 are Registered Trademarks. U.S. Patent No. 9,820,882 U.S. Patent No. 9,808,327 PRO3-060-A (June 2018) European Authorized Representative Medical Device Safety Service Schiffgraben Hannover, Germany Tel.: Certification Body Australia 810 Pacific Highway, Gordon NSW 2072, Australia Phone:

36 36 Leader in Precision OAT