Oventus O2Vent Optima Instructions For Use Manual
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Oventus O2Vent Optima Instructions For Use Manual

Dental healthcare
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Instructions for Use
O2Vent
Optima
®
Oral Appliances
for Sleep Apnea
Therapy

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Summary of Contents for Oventus O2Vent Optima

  • Page 1 Instructions for Use O2Vent Optima ® Oral Appliances for Sleep Apnea Therapy...
  • Page 2 Name of User Name of Sleep Physician Name of Dentist Device name and Serial No. Date of first fitting/purchase Connector band starting titration length and strength Date of follow up with Physician/Dentist...

  • Page 3: Table Of Contents

    - Removing your O2Vent Optima - Finding the right titration setting Tips for wearing your O2Vent Optima Risks and Contraindications O2Vent Optima cleaning instructions General warnings and precautions Maintenance Replacing Connector Bands Keep a log of your O2Vent Optima titration OVENTUS...

  • Page 4: Introduction

    This is caused by obstructions of the nose, soft palate and tongue. Ensure that you read these Instructions for Use BEFORE inserting and using your O2Vent Optima. OVENTUS...

  • Page 5: Indications For Use

    Indications for use The O2Vent 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.

  • Page 6: Product Designs And Description

    Product designs and description O2Vent Optima is available in two design options to help your Dental Healthcare Professional provide the most suitable treatment for you. • The O2Vent Optima features an extended airway at the mouth opening. • The O2Vent Optima Mini comes without the extended airway.

  • Page 7: Your O2Vent Optima Kit

    Your O2Vent Optima kit Your O2Vent Optima is created specifically to fit your teeth. Your device comes fully assembled with 19mm length connector bands*. All O2Vent Optima kits contain: • One set of either ‘soft’ (light blue) or ‘firm’ (dark blue) connector bands, as selected by your Dental Healthcare Professional, to adjust titration.

  • Page 8: How Your O2Vent Optima Device Works

    3. Your Dental Healthcare Professional will fit and assess your device to ensure it is working to treat your snoring and/or sleep apnea. Regardless of the design (with or without the extended airway) the O2Vent Optima works in the following way. OVENTUS...
  • Page 9 (this opens the airway and stabilizes the tongue) O2Vent Optima If difficulty with nasal breathing occurs, the O2Vent Optima can provide an alternative pathway. O2Vent Optima Mini The unique air channel allows for uninterrupted airflow to the back of the airway.

  • Page 10: O2Vent Optima Device Features

    O2Vent Optima device features* Airway channel allows the air to flow from the front to the Airway channel allows the air to flow back of the device, bypassing from the front to the back of the device, multiple obstructions bypassing multiple obstructions...
  • Page 11 The O2Vent Optima consists of the following parts (refer to image on page 4): • Upper tray (upper teeth) • Lower tray (lower teeth) • Connector bands The upper and lower trays are connected to each other by the connector bands and will be delivered assembled: - The bands are used to move the lower jaw (i.e.

  • Page 12: Optional Use Of Elastic Bands

    Your Dental Healthcare Professional may determine that your O2Vent Optima device requires intra oral elastic bands (elastic bands) . All O2Vent Optima devices allow for the addition of elastic bands to secure the upper and lower trays of your device while in use.
  • Page 13 Hook each elastic band around the notch in the upper and lower trays (on each side) as shown on page 10, and insert your O2Vent Optima device into your mouth according to the instructions on page 12. Elastic band precautions •...

  • Page 14: Using Your O2Vent Optima

    Using your O2Vent Optima Inserting your O2Vent Optima Before your sleep period 1. Inspect your O2Vent Optima; make sure the air channel is clear. 2. Make sure your O2Vent Optima is connected with the bands and they are the same length on each side.

  • Page 15: Finding The Right Titration Setting

    • Adjustments to the titration setting using connector bands are to be made under the direction of your treating Dental Healthcare Professional. • Your O2Vent Optima will be delivered ready to use, fitted with the 19mm connector bands as the recommended starting titration for all new users.
  • Page 16 Note: The shorter the connector band, the further the lower jaw is advanced. The longer the connector band, the less the lower jaw is advanced. O2Vent Optima lower jaw positioning range Longer length band = less advanced jaw Starting band titration...

  • Page 17: Tips For Wearing Your O2Vent Optima

    • It might be helpful for you to track how much you use your O2Vent Optima, this will help you to get into the habit of applying your O2Vent Optima before your sleep period.

  • Page 18: Risks And Contraindications

    OSA? • Type-2 diabetes • Depression, impotence, mood disorders and increased risk of motor vehicle and workplace accidents The O2Vent Optima device is contraindicated for patients who: • Have central sleep apnea • Have severe respiratory Contra- disorders indications •...

  • Page 19: O2Vent Optima 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 20 Step 1 • Conduct the daily cleaning (refer to page 17). Step 2 • Fill the Oventus tub provided about ¾ full (about ½” below the top) with warm water. • Place the antibacterial cleanser and the O2Vent Optima device in the water so that they are completely submerged...
  • Page 21 • 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 O2Vent Optima device with an antibacterial cleanser, remove device and rinse thoroughly with lukewarm water.

  • Page 22: General Warnings And Precautions

    General warnings and precautions Use of the O2Vent Optima may cause the following side effects: • Tooth movement, discomfort, pain or changes in dental occlusion • Dental soreness • Pain or soreness to the temporomandibular joint (TMJ) • Excessive salivation •...
  • Page 23 Do not use toothpaste or mouthwash to clean your O2Vent Optima • If you require dental work such as fillings, crowns, extractions etc., these may change the fit of your O2Vent Optima. You should always discuss this with your Dental Healthcare Professional •...

  • Page 24: Maintenance

    Maintenance Your O2Vent 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. Connector bands Once you have determined the band length that optimizes your therapy, you can re-order them in packs of 25.

  • Page 25: Replacing Connector Bands

    Replacing Connector Bands The connector bands (bands) are essential for keeping your O2Vent Optima device assembled and to maintain the lower jaw position. Routine band replacement • It is recommended to change both bands monthly as they may lose elasticity. How to identify that the bands need changing •...
  • Page 26 Repeat this action with the other end of the band to connect the upper and lower trays. Step 4 – Repeat step 3 with the second band. OVENTUS...

  • Page 27: Keep A Log Of Your O2Vent Optima Titration

    Keep a log of your O2Vent Optima titration It may be helpful to keep a usage log of your O2Vent Optima for the first month of wear. It may take several weeks or longer to achieve the best therapy. Refer to page 14 for the lower jaw positioning range as a guide.
  • Page 28 MANUFACTURED FOR: Australia: Oventus Medical Limited USA: Oventus Medical USA, Inc. Canada: Oventus Medical Canada, Inc. Australia: 1300 533 159 (Toll Free) customercare@oventusmedical.com USA and Canada: 1-866-835-0116 (Toll Free) support@oventusmedical.com O2Vent.com PRODUCT CODE: O2vent Optima: O2VB O2Vent Optima Mini: O2VBM R134_2021-02...

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