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

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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

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• 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

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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

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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

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KEEP A LOG OF YOUR TITRATION SETTINGS
The table below is an example of how you may keep a log of
your titration setting and should be completed for the rst
month. The table is provided on the back page.
Date Comment How many turns Titration
1st May 2018 None
2nd May 2018 Snoring, made
adjustment
One turn
both sides
+0.1mm
3rd May 2018 Still snoring,
adjusted further
Three turns
both sides
+0.3mm
4th May 2018 Less snoring,
adjusted further
One turn
both sides
+0.1mm
5th May 2018 No snoring None
6th May 2018 Some jaw discomfort,
adjusted back
One turn
both sides
-0.1mm
7th May 2018 Improved None

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CARING FOR YOUR O2VENT™ WDEVICE
Your O2Vent W device
is made of quality
biocompatible materials to
provide comfortable and
eective treatment. To
maintain the lifetime of your
device, we recommend you
follow the cleaning regime.
DAILY CLEANING
After each use of your O2Vent W device, it is recommended
that you follow these cleaning instructions:
1. Remove the device from
your mouth and rinse in
lukewarm water.
2. Clean the device with a
soft clean toothbrush (not
the same toothbrush you
use to brush your teeth as
toothpaste can damage
the device).
3. Thoroughly rinse the
device with lukewarm
water, including the airway
entry and exit points.
4. Shake as much of the water
as possible from the device,
especially from the airways.
5. Dry your device after each
cleaning with a clean tissue
or towel and store it in the
Oventus tub provided, with
the lid open to allow the
internal airway to dry.
6. Ensure you clean your
teeth before you insert
your device.

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TWICE A WEEK – CLEANING YOUR O2VENT™ W DEVICE
Clean your device more thoroughly twice a week, or more
frequently as required, using the provided Oventus tub and
an eervescent antibacterial cleaning tablet, designed for
oral appliances. To clean your device twice weekly:
• Clean your device as you
would for Daily Cleaning
(refer to Page 12).
• Fill the Oventus tub to ¾
full with warm water.
• Separate the two parts of
the device.
• Place the cleaning tablet
and the two parts of the
device in the water so
that they are completely
submerged.
• Leave to soak for 15
minutes.
• Remove and rinse both the
device parts and Oventus tub
thoroughly with lukewarm
water, including the airway
entry and exit points, to
remove the cleaning solution.
• Dry your device parts with
a clean tissue or towel and
place back in the Oventus
tub, with the lid open, to
allow the internal airway
to dry.
• Before using your device,
assemble the two parts of
the device together again.

14 OVENTUS
OTHER CLEANING HINTS FOR YOUR O2VENT™ W DEVICE
• Over time, the polymer might change color depending
on several parameters including how well you take care
of your device. It will not aect the eectiveness of your
device. Certain foods and liquids can stain your device. Be
sure to brush your teeth before inserting your device at
each use.
• Never use chlorine based products, bleach or acetic acid.
• Never put the device in water warmer than 45°C / 113 °F.
Cleaning with hot or boiling water can damage your device
and will void the warranty.
• Never use toothpaste or mouthwash to clean your device,
as they may be too abrasive and cause discoloration.
Your O2Vent 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.
Store your O2Vent W device in the
Oventus tub
14 OVENTUS

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• If dental work such as llings, crowns and
extractions are carried out, it may aect the
t of the inserts, which may need replacing.
Please seek advice from your Prescribing
Professional.
• Never attempt to remove or dislodge the
polymer inserts. If the polymer is damaged
signicantly or separates from the titanium,
it must be replaced by the manufacturer. To
replace the polymer insert material, contact
your Prescribing Professional. 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
and it must be replaced by the manufacturer.
Do not disassemble any of the O2Vent W device
elements as it is a medical device that must
not be tampered with.
• The O2Vent 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).
DEVICE PRECAUTIONS

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POTENTIAL SIDE EFFECTS
During the adjustment time and while you are getting used
to your O2Vent W device, it is normal to experience some side
eects which may include:
• Excessive salivation
• Temporary bite change. This will subside approximately
30 minutes after the O2Vent W device is taken out of the
mouth in the morning.
• Permanent bite change
• Gingival or dental soreness
• Dry mouth
• Gum irritation
• Cheek or tongue pain
• Jaw discomfort/pain
• Jaw set (lock)
• Temporomandibular Joint pain (TMJ)
• Tooth movement or loosening
• Tooth discomfort/pain
If any side eects persist following adjustment, please seek
advice from your Prescribing Professional.

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KEEP A LOG OF YOUR TITRATION SETTINGS
Please ll in the table below for your titration setting for the
rst month of use. See Page 11 for an example of how to
complete the table.
Date Comment How many turns Titration

18 OVENTUS
KEEP A LOG OF YOUR TITRATION SETTINGS
Date Comment How many turns Titration

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Date Comment How many turns Titration

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.
PRODUCT CODE: O2VWUS R53_May 2018
Oventus Manufacturing Pty Ltd
1 Swann Road, Indooroopilly,
QLD, 4068, Australia
www.oventusmedical.com