Oventus O2VENT OPTIMA Instructions For Use Manual

Oventus O2VENT OPTIMA Instructions For Use Manual

Oral appliance for sleep apnea therapy
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INSTRUCTIONS FOR USE – USA
O
VENT
®
2
OPTIMA
ORAL APPLIANCE
FOR SLEEP APNEA
THERAPY

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Summary of Contents for Oventus O2VENT OPTIMA

  • Page 1 INSTRUCTIONS FOR USE – USA VENT ® OPTIMA ORAL APPLIANCE FOR SLEEP APNEA THERAPY...
  • Page 2 Name of User Name of Sleep Physician Name of Dentist Serial No. of Device Date of first fitting/purchase Connector band starting titration length Date of follow up with Physician/Dentist...
  • Page 3: Table Of Contents

    Inserting your Optima Removing your Optima Finding the right titration setting Tips for wearing your Optima What are the risks of OSA Contraindications Cleaning instructions General warnings and precautions 17 Maintenance Replacing connector bands Keep a log of your titration OVENTUS...
  • Page 4: Vent ® Optima

    (OSA) therapy. OSA is a condition where a sufferer experiences repetitive episodes of partial or complete blockage of the upper-airway during sleep. This is caused by obstructions of the nose, soft palate and tongue. OVENTUS...
  • Page 5: Indications For Use

    The Optima is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild or moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions. OVENTUS...
  • Page 6: Optima Description

    OPTIMA DESCRIPTION Your Optima features the following components: Optima parts (before assembly): lower tray, upper tray and connector bands Upper tray with airway Lug for attaching connector band Connector band Lower tray Optima (fully assembled) OVENTUS...
  • Page 7: Your Optima Kit

    • Two sets of connector bands to adjust titration. Each set of bands has 9 length size options ranging from 13-21mm. The size is marked on the band. • Oventus tub • Instructions for use • Warranty • Antibacterial cleanser tablets...
  • Page 8: How Your Optima Device Works

    (this opens the airway and stabilizes the tongue) Provides a unique air channel in case of nasal congestion or difficulties with breathing through the nose. The air channel allows the air to flow smoothly to the back of the airway. OVENTUS...
  • Page 9 In order to make the Optima, an image of your teeth is taken by the dentist. This image is sent to Oventus where your customized Optima will be made. When the Optima is ready, your Dental Healthcare Professional will fit and assess how well the Optima works to treat your snoring and/or OSA.
  • Page 10 Professional will help you to find the right length of connector bands to receive the best therapy. In some instances, your Dental Healthcare Professional may recommend a different starting length for your connector bands based on your jaw anatomy. OVENTUS...
  • Page 11: Using Your Optima

    The Optima trays should never be worn separately. Always wear both trays (assembled with the connector bands) when using the device. Please check to ensure your connector bands are securely fastened on your Optima before using. Loose bands may pose a choking risk. OVENTUS...
  • Page 12: Finding The Right Titration Setting

    If your Dental Healthcare Professional suggests a shorter or longer length band, refer to the diagram on page 10 for length and titration information. • After your settings have been established, you should wear your Optima each sleep period. OVENTUS...
  • Page 13 19mm 21mm 20mm 18mm 17mm 16mm 15mm 14mm 13mm Minimum Maximum lower jaw lower jaw advancement advancement Retrusion 2mm Advancement 6mm Titration length range: 13-21mm. The shorter the connector band length, the further the lower jaw is moved forward OVENTUS...
  • Page 14: Tips For Wearing Your Optima

    Moving the chin backwards and close your back teeth together while biting down. Repeat 5 to 10 times. • Eat breakfast or chew sugar-free gum; it will help to return to a normal bite. Should you experience morning discomfort, seek the advice of your Dental Healthcare Professional. OVENTUS...
  • Page 15: What Are The Risks Of Osa

    The Optima device is contraindicated for patients who: • Have central sleep apnea • Have severe respiratory CONTRA- disorders INDICATIONS • Have loose teeth or advanced periodontal disease or restorative needs • Are under 18 years of age OVENTUS...
  • Page 16: Cleaning Instructions

    Ensure the airway entry and exit are free from any debris. • Dry your device after each cleaning with a cloth and shake to clear water from the airway. • Return to the Oventus tub to store, with the lid open to allow the internal airway to dry. OVENTUS...
  • Page 17 • Conduct the daily cleaning (refer to page 14). Step 2 • Fill the Oventus tub provided about ¾ full (about ½” below the top) with warm water. • Place the antibacterial cleanser and the Optima device in the water so that they are completely submerged and leave them to soak, following the recommended time according to the cleanser packet instructions.
  • Page 18 • Dry your device after each cleaning with a clean cloth. • Return to the Oventus tub to store, with the lid open to allow the internal airway to dry. After soaking the Optima device with an antibacterial cleanser, remove device promptly and rinse thoroughly with lukewarm water.
  • Page 19: General Warnings And Precautions

    Optima device. Dry mouth can lead to gum disease such as gingivitis. Should you experience this symptom, seek the advice of your Dental Healthcare Professional. If any side effects or ongoing dental issues persist while using the Optima, please seek advice from your Dental Healthcare Professional. OVENTUS...
  • Page 20 The Optima trays should never be worn separately. Always • wear both trays (assembled with the connector bands) when using the device. • Please check to ensure your connector bands are securely Optima fastened on your before using. Loose bands may pose a choking risk. OVENTUS...
  • Page 21: Maintenance

    MAINTENANCE Your Optima should be stored in the Oventus tub provided as shown, during transport or when not in use. Keep your device away from sunlight and out of reach of pets and children. Once you have determined the band length that optimizes your therapy, you can re-order them in packs of 25.
  • Page 22: Replacing Connector Bands

    To apply a connector band, hook the band over the pointed end of the “lug” and pull gently to hook over the wider “lug” end. Wider Pointed end of lug end of lug Separate upper and lower device parts as shown to remove connector bands OVENTUS...
  • Page 23: Keep A Log Of Your Titration

    After 1 week wearing, still snoring, some dribble. 1 Sep 2018 Changed to shorter band EXAMPLE: 18mm Still snoring, less dribble. Changed to shorter 8 Sep 2018 band EXAMPLE: 17mm Worn for 2 weeks. No snoring. Dribble stopped 22 Sep 2018 OVENTUS...
  • Page 24 WARRANTY: Please see the Oventus Warranty Policy Card included with your device. CAUTION: Federal (US) law restricts this device to sale by or on order of a dentist. MANUFACTURER AND AUSTRALIAN SPONSOR: Oventus Manufacturing Manufactured for: Pty Ltd Oventus Medical USA, Inc...

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