Oventus ExVent O2Vent Optima User manual

Instructions for Use
ExVent®
Optional
accessory for
use with O2Vent
Optima®
Introduction
The ExVent®is an optional accessory that can only
be used with the O2Vent Optima®. Your Healthcare
Professional will determine
if using the ExVent
is right for you.
Why might ExVent be needed?
The ExVent provides the airway with extra, mild “end of breath”
support, also known as Expiratory Positive Airway Pressure (EPAP).
How does it work?
The ExVent is inserted into the extended airway of the O2Vent
Optima (not compatible with the O2Vent Optima Mini, as it does
not have an extended airway). The ExVent includes a valve with air
holes. This valve opens and closes as you breathe.
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. Talk to your Healthcare Professional about which
strength to use when starting treatment with ExVent.
Valve with air holes
ExVent front lip
Indications for use
The ExVent is an optional accessory to be used with the O2Vent
Optima device in adult patients with mild to moderate obstructive
sleep apnea.
The O2Vent Optima is a removable medical device that is tted 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.
Figure 1: ExVent – breathing in
Upon breathing in,
the ExVent’s valve
fully opens which
allows for the free
ow of air into the
airway.
Figure 2: ExVent – breathing out
When breathing out,
the valve closes,
directing your breath
through the air holes
in the valve. This
creates EPAP. Back
Front
O2Vent Optima
ExVent
2

Contraindications
The ExVent is an accessory for the O2Vent Optima device.
Both are contraindicated for patients who:
• have central sleep apnea
• have a severe respiratory disorder
• have loose teeth or advanced periodontal disease or
restorativeneeds
• are under 18 years of age.
About ExVent
The ExVent valves are available in three pressure strengths to
deliver airway support. These are labeled and colored:
• Low airway support (Light Blue)
• Medium airway support (Yellow)
• High airway support (Dark Blue)
The higher the pressure strength, the more resistance you will
experience when breathing out. If you nd breathing out through a
particular strength dicult, speak to your Healthcare Professional.
Instructions to insert ExVent into your O2Vent
Optima device
The ExVent must be inserted into your O2Vent Optima device
before inserting into your mouth (to be worn during sleep periods).
1. Hold the ExVent between your ngers in the middle as shown.
2. Ensure that the ExVent valve (that opens and closes) is lying at
against the back of the ExVent when you insert it. Refer to image
bottom left of page.
3. Insert the ExVent into the extended airway of your O2Vent
Optima.
4. When correctly inserted, the retention clips will “click” into place.
5. Once the ExVent is inserted, follow the Instructions for Use for
your O2Vent Optima.
Continued overleaf
Insert the ExVent into the extended
airway of your O2Vent Optima.
Correctly inserted ExVent
**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.
LOW MEDIUM HIGH
Retention
clips
1
4
3
5

Tips for use:
1. If you are nding it uncomfortable or
dicult to breathe out of your ExVent, you
can insert your O2Vent Optima device and ExVent
into your mouth prior to your sleep period, to practice
getting used to it while awake.
2. One exercise to help you adapt to your ExVent is to breathe in
(WITHOUT your O2Vent Optima device in your mouth) and then
slowly breathe out with your lips tightly pressed together, as if
blowing a kiss.
Daily cleaning of your ExVent
After each use of your O2Vent Optima 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 Optima
device by gently
squeezing the middle to
disengage the retention
clips 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 Optima device
• Leave the ExVent to
dry in the Oventus tub,
with the lid open. Do
not place the ExVent
into the O2Vent Optima
device to dry.
For cleaning of your O2Vent
Optima device, please refer
to the Instructions for Use
provided with your device.

Additional cleaning
Separate, clean and thoroughly rinse both your O2Vent Optima
device and ExVent twice a week, or more frequently as required,
using an antibacterial cleanser (free from chlorine, bleach, acetic
acid or alcohol-based products)
ExVent potential side eects
The most commonly experienced side eects may include:
Warning:
• If you experience diculties with your ExVent and/or O2Vent
Optima, contact your prescribing Healthcare Professional.
• Follow-up testing and evaluation should be conducted to ensure
treatment eectiveness.
Replacement of ExVents
Your ExVent should be replaced every three months, or more
frequently if your Healthcare Professional recommends it.
Your Healthcare or Dental Healthcare Professional can order
Annual Resupply Packs (4 x ExVents) for you.
• Caution: Federal law
restricts this device to
sale by oron the order of
a healthcare practitioner.
• Healthcare Professionals
should consider the
medical history of the
patient, including history
of asthma, breathing, or
respiratory disorders,
or other relevant health
problems, and refer the
patient to the appropriate
healthcare provider
before recommending
theExVent.
• When cleaning, do
not use bleach-based
products oracetic acid.
• Do not put your ExVent
in water warmer than
45°C or113°F.
• Before insertion, check
that your O2Vent Optima
device and ExVent are
not damaged and are
completely dry before
use. Do not use if
damaged. Replace.
• Choking hazard – small
parts. Keep away from
children under 3 years.
• Single patient multiple use.
• Dry mouth/throat/lips
• Nasal congestion / runny nose
• Throat or ear discomfort
• Breathing discomfort
• Headache
• Diculty falling asleep
and staying asleep
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
R148AUS/CAN_2021-11
MANUFACTURER AND
AUSTRALIAN SPONSOR:
Oventus Manufacturing
Pty Ltd
1 Swann Road,
Indooroopilly
QLD 4068, Australia
MANUFACTURED FOR:
Australia: Oventus Medical Limited
Canada: Oventus Medical Canada, Inc.
Australia:
1300 533 159 (Toll Free)
[e-mail]
Canada:
1-866-835-0116 (Toll Free)
[e-mail]
O2Vent.com