Oventus O2VENT W User manual

REMOVABLE
MEDICAL
DEVICE
INSTRUCTIONS FOR USE – USA
O2 VENT™W

2OVENTUS
Name of User
Name of Sleep Physician
Name of Dentist
Serial No. of Device
Date of rst tting/purchase
Date of follow up with Physician/Dentist

3
OVENTUS
This product is customized. Please contact your
Prescribing Professional for ttings and consultations.
Obstructive Sleep Apnea (OSA) occurs when patients
experience repetitive episodes of partial or complete
blockage of the upper-airway during sleep. This is caused by
obstructions of the nose, soft palate, tongue and/or pharyngeal
walls (abnormal relaxation of the pharyngeal muscles
during sleep). OSA suerers usually snore, and may wake
up gasping or choking. However, many people with OSA are
unaware of any sleep disturbance. OSA is a common cause of
excessive daytime tiredness, fatigue and poor concentration.
INDICATIONS FOR USE
The O2Vent W device is a removable medical device that is
tted in the patient’s mouth and is intended to reduce or
alleviate snoring and mild to moderate obstructive
sleep apnea (OSA). The device is indicated for
use during sleep to aid in the treatment
of these conditions.
INTRODUCTION

4OVENTUS
• Detrimental eects on
sleep-quality and health
• Increases the risk of obesity
• High blood pressure
• Stroke
• Heart attack
• Type-2 diabetes
• Depression, impotence,
mood disorders and
increased risk of motor
vehicle and workplace
accidents
WHAT ARE
THE RISKS
OF OSA?
The O2Vent W device is
contraindicated for patients who:
• Have central sleep apnea
• Have severe respiratory
disorders
• Have loose teeth or
advanced periodontal
disease or restorative needs
• Are under 18 years of age
• Patients with TMJ
(Temporomandibular
Joint) pain
CONTRA-
INDICATIONS

5
OVENTUS
• O2Vent W device
• Adjustment Key
• Oventus tub
• Eervescent antibacterial cleaning tablets
• Instructions for Use booklet
• Warranty
THE BASICS OF YOUR O2VENT™ WDEVICE
O2Vent W device with titanium airway and polymer inserts
O2Vent W Adjustment Key
O2Vent W device kit contents:
The O2Vent W device may be used in conjunction with other
accessories in the O2Vent product line. For the full range of
O2Vent products, please visit www.oventusmedical.com or
contact your Prescribing Professional.

6OVENTUS
HOW YOUR O2VENT™ W DEVICE WORKS
Like all oral appliances that bring the jaw forward, the
O2Vent W device stabilizes jaw position and brings the tongue
forward to reduce airway collapse. In addition, the unique
airway design allows for breathing through the device to
bypass obstruction in the nose which can contribute to
snoring and sleep apnea.
The Adjustment Key allows for forward or backward
adjustment of the lower jaw to optimize treatment.
Air in on inhalation, air out on
exhalation (together with nose)
Adjustment screw to
optimize treatment
Lower jaw adjustment helps
clear tongue obstruction
Air in on inhalation,
air out on exhalation
(together with nose)
Hollow airway bypasses
multiple obstructions

7
OVENTUS
Your Prescribing Professional and hygienist team will ensure
that your device is appropriately customized for you. Your
therapy will include initial scans or impressions which allow
the device to be manufactured so that it is fully customized
and ts comfortably in your mouth.
After your Prescribing Professional ts the device, it may
take some time to get used to wearing it. The nal tting may
include one or more titration adjustments to advance your
jaw forward, to attain optimal positioning for your treatment.
You or your Prescribing Professional can further adjust the
lower jaw position forward or backward to optimize treatment
and minimize side eects. Device adjustments should only be
done under the direction of your Prescribing Professional.
USING YOUR O2VENT™ WDEVICE

1. Inspect the device prior to each use. If you observe any
material separation, material degradation or cracks, or
any debris in the airway, please stop using the device and
call your Prescribing Professional to discuss.
2. If the device is damaged or broken, the device must NOT
be used any longer. Immediately take it to your Prescribing
Professional who will arrange for it to be repaired.
3. Use your thumbs to push the upper tray from the bottom
to snap it over your teeth. Repeat the same process for
the lower tray.
4. Gently relax your jaw once the O2Vent W device is in
your mouth.
5. Check the device for any changes in adjustment during
overnight use. If there is movement or change in
adjustment, please call your Prescribing Professional.
6. To remove the O2Vent W device, open your mouth,
gently loosen the lower tray and remove. Do the same
for upper tray. NOTE: the upper and lower trays are not
locked together.
DIRECTIONS FOR DAILY USE
The O2Vent W trays should never be worn
separately. Always wear both trays when
using the device.
8OVENTUS

9
OVENTUS
TITRATING YOUR O2VENT™W DEVICE USING THE
ADJUSTMENT KEY
• Adjustments should be made with the device removed
from the mouth. The lower tray can be adjusted without
the upper tray attached.
• Take a few nights (up to one week) to get used to having
the device in your mouth.
• If snoring persists then position lower jaw forward using
the Adjustment Key as advised by your Prescribing
Professional until symptoms resolve.
• If pain or discomfort arises then reverse the last turn and
continue to position the lower jaw back until resolved. 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.
FORWARD ADJUSTMENT:
To pull your lower jaw
forward (increase titration),
insert the Adjustment Key
into the keyhole of the
adjustment screw and turn
in the direction of the arrow.

10 OVENTUS
BACKWARD ADJUSTMENT:
To return your lower jaw
(reduce titration), insert the
Adjustment Key into the
keyhole of the adjustment
screw and turn in the opposite
direction to the arrow.
NOTE: Your device can be adjusted within a 6.0 mm range.
One turn (top to bottom) using the Adjustment Key is 90°.
This will adjust the pitch of the screw by 0.1 mm resulting
in a 0.1mm titration.
The screws will only allow a 90° turn in one full adjustment.
Adjustments should be made with the Adjustment Key
pointed towards you with the view of the key hole of the
adjustment screw. 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.
TITRATING YOUR O2VENT™W DEVICE USING THE
ADJUSTMENT KEY