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Oventus O2VENT W Instructions For Use Manual

Removable medical device
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I N S T R U C T I O N S F O R U S E – U S A
O
VENT
W
™
2
REMOVABLE
MEDICAL
DEVICE

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Summary of Contents for Oventus O2VENT W

  • Page 1 I N S T R U C T I O N S F O R U S E – U S A VENT ™ REMOVABLE MEDICAL DEVICE...
  • Page 2 Name of User Name of Sleep Physician Name of Dentist Serial No. of Device Date of first fitting/purchase Date of follow up with Physician/Dentist OVENTUS...
  • Page 3 (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions. This product is customized. Please contact your Prescribing Professional for fittings and consultations. OVENTUS...

  • Page 4: What Are The Risks Of Osa

    • 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 • Patients with TMJ (Temporomandibular Joint) pain OVENTUS...
  • Page 5 Vent W Adjustment Key Vent W device kit contents: • Vent W device • Adjustment Key • Oventus tub • Effervescent antibacterial cleaning tablets • Instructions for Use booklet • Warranty The O Vent W device may be used in conjunction with other accessories in the O Vent product line.
  • Page 6 Air in on inhalation, air out on exhalation (together with nose) Air in on inhalation, air out on exhalation (together with nose) Hollow airway bypasses multiple obstructions Lower jaw adjustment helps Adjustment screw to clear tongue obstruction optimize treatment OVENTUS...
  • Page 7 You or your Prescribing Professional can further adjust the lower jaw position forward or backward to optimize treatment and minimize side effects. Device adjustments should only be done under the direction of your Prescribing Professional. OVENTUS...
  • Page 8 Do the same for upper tray. NOTE: the upper and lower trays are not locked together. The O Vent W trays should never be worn separately. Always wear both trays when using the device. OVENTUS...
  • Page 9 If the pain does not resolve, remove the device and seek advice from your Prescribing Professional. • Ensure that the same number of turns are performed on each side of your device. OVENTUS...
  • Page 10 Note to count your turns. Both sides should always be adjusted equally. Once the screw is at the end of the titration, do not use the Adjustment Key further to tighten the screw. This may lock or snap the screw in the device. OVENTUS...
  • Page 11 4th May 2018 Less snoring, One turn +0.1mm adjusted further both sides 5th May 2018 No snoring None 6th May 2018 Some jaw discomfort, One turn -0.1mm adjusted back both sides 7th May 2018 Improved None OVENTUS...

  • Page 12: Daily Cleaning

    Oventus tub provided, with toothpaste can damage the lid open to allow the the device). internal airway to dry.
  • Page 13 W DEVICE ™ Clean your device more thoroughly twice a week, or more frequently as required, using the provided Oventus tub and an effervescent antibacterial cleaning tablet, designed for oral appliances. To clean your device twice weekly: • Remove and rinse both the •...
  • Page 14 • Never use toothpaste or mouthwash to clean your device, as they may be too abrasive and cause discoloration. Your O Vent W device should be cleaned and 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.
  • Page 15 • The O Vent W device should not be worn by the user during any radiology procedures such as X-rays, Computer Tomography (CT) scanning or Magnetic Resonance Imaging (MRI). OVENTUS...

  • Page 16: Potential Side Effects

    • Cheek or tongue pain • Jaw discomfort/pain • Jaw set (lock) • Temporomandibular Joint pain (TMJ) • Tooth movement or loosening • Tooth discomfort/pain If any side effects persist following adjustment, please seek advice from your Prescribing Professional. OVENTUS...
  • Page 17 KEEP A LOG OF YOUR TITRATION SETTINGS Please fill in the table below for your titration setting for the first month of use. See Page 11 for an example of how to complete the table. Date Comment How many turns Titration OVENTUS...
  • Page 18 KEEP A LOG OF YOUR TITRATION SETTINGS Date Comment How many turns Titration OVENTUS...
  • Page 19 Date Comment How many turns Titration OVENTUS...

  • Page 20: Warranty

    WARRANTY: Please see the Oventus Warranty Policy Card included with your device. CAUTION: Federal (US) law restricts this device to sale by or on the order of a dentist. Oventus Manufacturing Pty Ltd 1 Swann Road, Indooroopilly, QLD, 4068, Australia www.oventusmedical.com...