Oventus ExVent User manual

INSTRUCTIONS FOR USE
INTRODUCTION
The Oventus ExVent™ (ExVent) is an accessory that can
be used in conjunction with the following O2Vent®oral
devices from the Oventus airway management system:
>O2Vent®Optima
>O2Vent®W
** The ExVent cannot be used
as a standalone device or be
used with products other
than O2Vent®oral devices.
The purpose of this accessory
is to provide the Healthcare Professional an option to augment traditional
mandibular advancement therapy.
Why might ExVent be needed? Sometimes the airway needs additional
help to stay open. This help is provided by the use of the ExVent valve,
which provides the airway with mild “end of breath” airway pressure/
support. ExVent is intended to assist in reducing or eliminating snoring
and/or obstructive sleep apnea.
How does it work? The ExVent is inserted into the oral airway in the
front of the O2Vent®device. The ExVent is a valve with air vents. This valve
opens and closes as you breathe.
> Upon breathing in, the valve fully opens which allows for the free ow
of air into the airway.
> When breathing out, the valve closes, directing your breath through
the air vents. This creates the mild pressure or airway support
required to keep the airway open. This type of valve is sometimes
known as Positive End Expiratory Pressure (PEEP) or End Positive
Expiratory Pressure (EPAP).
The ExVent oers three dierent levels of airway support: low, medium and
high. This refers to the amount of airway pressure the ExVent generates.
Your Healthcare Professional will determine if this mode of therapy is the
right one for you to use to reduce your snoring and/or sleep apnea.
Indications for Use
The Oventus ExVent is an accessory that can be used with the O2Vent®
range of oral devices to assist with the intended use of reducing or
alleviating snoring and/or obstructive sleep apnea (OSA).
The ExVent is a one-way valve that opens when breathing in and
closes when breathing out, prolonging the breath. This creates
positive pressure or upper airway support and may improve user
outcome and comfort when used with your O2Vent®device. The
ExVent is an optional accessory. A prescription is required.
EXVENT™ – BREATHING OUTEXVENT™ – BREATHING IN
The valve closes when breathing out.
The vents control airow to create
mild pressure or airway support.
The valve opens when breathing in
allowing for free airow.
Valve with air vents
ExVent front lip
OVENTUS
EXVENT™

Contraindications
The ExVent is contraindicated for patients who:
> have central sleep apnea
> have severe respiratory disorders
> are under 18 years of age.
Always consult with your Healthcare Professional before starting treatment.
They will establish whether the ExVent is the correct treatment for you.
Use only under the supervision of a Healthcare Professional.
About ExVent
The ExVent valves are available in three pressure strengths for airway
support. These are labeled:
> Low airway support (have four large sized vents for low pressure
airway support and are Light Blue in color)
> Medium airway support (have four medium sized vents for medium
pressure airway support and are Yellow in color)
> High airway support (have only two vents to provide the highest
pressure airway support and are Dark Blue in color)
One may experience more diculty in breathing out against the higher
airway support.
Instructions to insert ExVent into your O2Vent®device
If you use an ExVent valve, it must be inserted into your O2Vent®device
before inserting into your mouth (to be worn during sleep periods).
1. Before insertion, check that your O2Vent®device and ExVent are not
damaged and are completely dry before use. Do not use if damaged.
Replace.
2. Holding your ExVent between your ngers in the middle as shown,
insert it into the oral airway inlet of your O2Vent®device. Push the
ExVent in straight so the retention clips click into place and the front
lip sits ush around the edge of the front inlet of your O2Vent®device.
Ensure that the part of the ExVent valve that opens and closes is lying
at against the body of the ExVent when you insert it.
3. Once the ExVent is inserted, follow the Instructions for Use for your
your O2Vent®oral device.
** On rare occasions, the part of the ExVent valve that opens and closes
might stick, fold over or twist. Should this happen, remove the ExVent,
check that it is dry and realign so the valve sits at against the body of
the ExVent. Use a new ExVent if necessary.** Continued overleaf
Insertion of the ExVent into the O2Vent®Optima.
Push the ExVent in straight so the retention clips
click into place and the valve edges are sitting at.
Retention clips
LOW MEDIUM HIGH

Daily cleaning of your ExVent
After each use of your O2Vent®oral device, it is recommended
that you:
> Remove the device from your mouth and rinse in lukewarm water
> Remove the ExVent from
the front inlet of the O2Vent®
device by gently squeezing
the middle to disengage the
retention clip before pulling it
out, taking care not to damage
the ExVent
> Thoroughly rinse the ExVent
with lukewarm water
> Pat dry the ExVent with a clean
tissue or towel (do not rub/
wipe) and store in the Oventus
tub that is provided with the
O2Vent®device
> Leave the ExVent to dry in the
Oventus tub, with the lid open.
Do not place the ExVent into
the O2Vent®device to dry.
For cleaning of your O2Vent®
device, please refer to the
Instructions for Use provided with
your device.
TIPS:
1. If you are nding it uncomfortable or dicult
to breathe out of your ExVent, you can insert your
O2Vent®device and ExVent prior to your sleep period,
to practice getting used to it while awake.
2. One exercise to help you adapt to your ExVent valve is to
breathe in (WITHOUT your O2Vent®device in your mouth) and
then slowly breathe out with your lips tightly pressed together,
as if blowing a kiss.

Twice a week – cleaning your ExVent
Clean your ExVent more thoroughly twice a week, or more frequently as
required, using an antibacterial cleaning agent. These are readily available
in stores. Follow the cleaning agent Instructions for Use.
ExVent Precautions
Do not use chlorine-based products, such as denture
cleanser. Do not use bleach or acetic acid. Do not put
your ExVent in water warmer than 45°C or 113°F.
WARNING: Choking hazard - small parts
Keep away from children under 3 years.
Potential Side Eects
The most commonly experienced side eects may include:
> Dry mouth/throat/lips
> Nasal congestion / runny nose
> Throat or ear discomfort
> Breathing discomfort
> Headache
> Diculty falling asleep and staying asleep
Warning:
> If you experience diculties with your ExVent, contact your
prescribing Healthcare Professional
Supply of your ExVent
The ExVent is supplied in a starter pack with one of each of the three
available airway support strengths and is called a ‘Multipack’. Your
Healthcare Professional will work with you to nd the best strength for
you. The intended life for each ExVent is three months’ use.
Replacement of ExVents
Your ExVent should be replaced every three months. You can order
more ExVents in Annual Resupply packs of four.
Your Healthcare Professional may recommend that you replace your
ExVent more frequently and will advise on the most suitable airway
support strength to re-order.
For information on ordering an ExVent Annual Resupply Pack, please visit
o2vent.com or ask your Healthcare Professional.
ExVent Product Codes:
Low Airway Support – Annual Resupply Pack: EXVL-AR
Medium Airway Support – Annual Resupply Pack: EXVM-AR
High Airway Support – Annual Resupply Pack: EXVH-AR
Multipack (one of each, Low, Medium and High Airway Support): EXVMP
Clinic Multipack (24): EXV-CM
R57B_Aug 2019
Manufacturer and Australian Sponsor:
Oventus Manufacturing Pty Ltd
1 Swann Road, Indooroopilly, QLD 4068 Australia
Ph: ([phone]
(Toll free only in Australia)
[email protected]
Manufactured for:
Oventus Medical USA, Inc.
Oventus Medical Canada, Inc.
Toll free in USA: 1-866-835-0116
[email protected]
o2vent.com
Rx ONLY