Oventus O2VENT OPTIMA User manual

Oral Appliances
for Sleep Apnea
Therapy
O2Vent
Optima®
Instructions for Use

Name of User
Name of Sleep Physician
Name of Dentist
Device name and Serial No.
Date of rst tting/purchase
Connector band starting titration length and strength
Date of follow up with Physician/Dentist

1OVENTUS
Instructions for use for O2vent Optima®
Contents
Introduction 2
Indications for use 3
Product designs and description 4
Your O2Vent Optima kit 5
How your O2Vent Optima device works 6
O2Vent Optima device features* 8
-Optional use of elastic bands 10
Using your O2Vent Optima 12
-Inserting your O2Vent Optima 12
-Removing your O2Vent Optima 12
-Finding the right titration setting 13
Tips for wearing your O2Vent Optima 15
Risks and Contraindications 16
O2Vent Optima cleaning instructions 17
General warnings and precautions 20
Maintenance 22
Replacing Connector Bands 23
Keep a log of your O2Vent Optima titration 25

2OVENTUS
Introduction
Congratulations, you have taken the rst
steps to improve your sleep and well-being!
Your Dental Healthcare Professional has
chosen the O2Vent Optima®(O2Vent Optima)
for your snoring and/or obstructive sleep
apnea (OSA) therapy. OSA is a condition
where a suerer experiences repetitive
episodes of partial or complete blockage of
the upper-airway during sleep. This is caused
by obstructions of the nose, soft palate
andtongue.
Ensure that you read these Instructions for Use BEFORE
inserting and using your O2Vent Optima.

3OVENTUS
Indications for use
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.
O2Vent Optima Mini

4OVENTUS
O2Vent Optima* (fully assembled)
O2Vent Optima* parts
(before assembly)
O2Vent Optima Mini* parts
(before assembly)
O2Vent Optima is available in two design options to help
your Dental Healthcare Professional provide the most suitable
treatment for you.
• The O2Vent Optima features an extended airway at the
mouth opening.
• The O2Vent Optima Mini comes without the extended airway.
The O2Vent Optima designs feature the following components:
Product designs and description
* Assembly is the same for both O2Vent Optima designs.
Upper tray with airway
Soft
connector
band
Lug for attaching
connector band
Each device features a lower tray, upper tray and connector bands
Lower tray

5OVENTUS
Your O2Vent Optima kit
Your O2Vent Optima is created specically to t your teeth.
Your device comes fully assembled with 19mm length
connector bands*. All O2Vent Optima kits contain:
• One set of either ‘soft’ (light blue) or ‘rm’ (dark blue)
connector bands, as selected by your Dental Healthcare
Professional, to adjust titration. Each set of bands has
9 length size options ranging from 13-21mm. The size
is marked on the band. The strength is marked on the
opposite side with an ‘S’for ‘soft’ (light blue bands) or an
‘F’for ‘rm’ (darkblue bands).
• Oventus tub
• Instructions for use
• Warranty
• Antibacterial cleanser tablets
It is important that you check the contents of your O2Vent
Optima kit and make sure that you nd everything listed
above. Please contact your Dental Healthcare Professional if
anything is missing.
* In some instances, your Dental Healthcare Professional may recommend a
dierent starting length for your connector bands based on your jaw anatomy.
‘Soft’ strength bands are the default strength and are light blue, ‘rm’ strength
bands are dark blue.
‘Soft’
strength
connector
bands
‘Firm’
strength
connector
bands

6OVENTUS
How your O2Vent Optima device works
The O2Vent Optima process:
1. Your Dental Healthcare
Professional will
provide Oventus an
image or impression
ofyour teeth.
2. Your O2Vent Optima
will be designed
specically to t
yourteeth.
3. Your Dental Healthcare Professional
will t and assess your device to ensure
it is working to treat your snoring and/or
sleep apnea.
Regardless of the design (with or without the
extended airway) the O2Vent Optima works in
the following way.
1

7OVENTUS
How your O2Vent Optima device works
If diculty with nasal
breathing occurs, the
O2Vent Optima can provide
an alternative pathway.
Brings/pulls the lower jaw
forward (this opens the airway
and stabilizes the tongue)
The unique air channel allows
for uninterrupted airow to
the back of the airway.
O2Vent Optima
O2Vent Optima Mini
2
1
3

8OVENTUS
O2Vent Optima device features*
* Elastic bands not included. If you have problems with mouth opening during
sleep, your Dental Healthcare Professional can provide the recommended length
and strength elastic bands, to keep your device in a closed position.
Air in on inhalation,
air out on exhalation
Notches to allow (optional)
attachment of dental
elastic bands
Connector band
enablesadjustment to
optimize treatment
Airway channel allows the air
to ow from the front to the
back of the device, bypassing
multiple obstructions
Airow is directed
towards the back
of the throat
Airway channel allows the air to ow
from the front to the back of the device,
bypassing multiple obstructions

9OVENTUS
* In some instances, your Dental Healthcare Professional may recommend a
dierent starting length for your connector bands based on your jaw anatomy.
The O2Vent Optima consists of the following parts (refer to
image onpage 4):
• Upper tray (upper teeth)
• Lower tray (lower teeth)
• Connector bands
The upper and lower trays are connected to each other by
the connector bands and will be delivered assembled:
- The bands are used to move the lower jaw (i.e. adjust the
trays) forward or backward.
- In order to adjust the trays to your specic needs,
the bands come in dierent lengths to enable
titration adjustment. There are 9 length size options
ranging from 13-21mm.
- Your new O2Vent Optima is delivered fully assembled
with the 19mm connector band as the recommended
starting titration length for all newusers*.
- The shorter the connector band, the further the lower
jaw is moved forward.
- After the initial use, your Dental Healthcare Professional
will help you to nd the right length of connector bands
to receive the best therapy.

10 OVENTUS
O2Vent Optima device features CONTINUED
Optional use of elastic bands
Your Dental Healthcare Professional may determine that
your O2Vent Optima device requires intra oral elastic bands
(elasticbands) .
All O2Vent Optima devices allow for the addition of elastic
bands to secure the upper and lower trays of your device
while in use.
If instructed to attach elastic bands, your Dental Healthcare
Professional may supply you with the elastic bands or advise
where to purchase them.
An example of an O2Vent Optima device with elastic bands
added is shown below.
Upper tray
notch
Lower tray
notch
Elastic band

11OVENTUS
To attach elastic bands (to both O2Vent Optima and
O2Vent Optima Mini):
Hook each elastic band around the notch in the upper and
lower trays (on each side) as shown on page 10, and insert
your O2Vent Optima device into your mouth according to the
instructions on page 12.
Elastic band precautions
• Ensure the elastic bands are replaced daily as they will lose
their strength and elasticity which could result in breakage.
• Should your O2Vent Optima device dislodge from your
teeth as a result of the elastic bands, a dierent size and/
or strength elastic band may be required. In this case,
please seek advice from your prescribing Dental Healthcare
Professional.
• Should you experience any pain or discomfort when
using your O2Vent Optima device with elastic bands
attached, please seek advice from your Dental Healthcare
Professional.
WARNING: Choking hazard – small parts
Keep away from children under 3 years.

12 OVENTUS
The O2Vent Optima trays should never be worn separately.
Always wear both trays (assembled with the connector
bands) when using the device.
Please check to ensure your connector bands are securely
fastened on your O2Vent Optima before using. Loose bands
may pose a chokingrisk.
Inserting your O2Vent Optima
Before your sleep period
1. Inspect your O2Vent Optima; make sure the air channel
isclear.
2. Make sure your O2Vent Optima is connected with the
bands and they are the same length on each side.
3. Make sure your O2Vent Optima is clean.
4. Rinse the O2Vent Optima and brush your teeth before
inserting.
5. Using your thumbs, insert the upper tray and gently “push”
onto the upper teeth; the tray should t snugly.
6. Insert the lower tray, “push” onto the lower teeth; the tray
should t snugly.
Removing your O2Vent Optima
After your sleep period
7. Remove your O2Vent Optima by gently opening your
mouth, lift up the lower tray and then pull down on the
upper tray. You might feel a little “resistance” initially.
8. Make sure BOTH trays are loosened before removing.
Using your O2Vent Optima

13OVENTUS
Finding the right titration setting
• Adjustments to the titration setting using connector
bands are to be made under the direction of your treating
Dental Healthcare Professional.
• Your O2Vent Optima will be delivered ready to use, tted
with the 19mm connector bands as the recommended
starting titration for all new users.
• During the initial phase of using your O2Vent Optima, you
will work closely with your Dental Healthcare Professional
to nd the correct position. It is important that you wear
your O2Vent Optima each sleep period according to your
Dental Healthcare Professional recommendations.
• Ensure the connector band lengths are the same on
eachside.
• The titration may take several weeks or longer to achieve
the best therapy.
• If your Dental Healthcare Professional suggests a shorter
or longer length band, refer to the diagram on page 14 for
length and titration information.
• After your settings have been established, you should wear
your O2Vent Optima each sleep period.

14 OVENTUS
The diagram below shows the lower jaw positioning range
that can be set by the connector band lengths. This is a
guideonly.
Note: The shorter the connector band, the further the lower jaw
isadvanced. The longer the connector band, the less the lower jaw
isadvanced.
O2Vent Optima lower jaw positioning range
Titration length range: 13-21mm. The shorter the connector band
length, the further the lower jaw is moved forward
Longer length band = less advanced jaw
Shorter length band = further advanced jaw
Minimum
lower jaw
advancement
Maximum
lower jaw
advancement
Starting
band titration
Advancement 6mmRetrusion 2mm
21mm 20mm 18mm19mm 17mm 16mm 15mm 14mm 13mm
Using your O2Vent Optima CONTINUED

15OVENTUS
It is important to use your O2Vent Optima during each sleep
period to receive the best possible outcome.
Tips
• If you are having problems adapting, try wearing your
O2Vent Optima while watching TV or reading. It will help
you to get used to using it.
• It might be helpful for you to track how much you use your
O2Vent Optima, this will help you to get into the habit of
applying your O2Vent Optima before your sleep period.
Refer to page 25 for a usage log.
Morning Jaw Exercises
As recommended by the American Academy of Dental Sleep
Medicine (AADSM), morning jaw exercises are often indicated
to improve jaw discomfort. To help with jaw discomfort, some
suggested activities include:
• Moving the chin backwards and close your back teeth
together while biting down. Repeat 5 to 10 times.
• Eat breakfast or chew sugar-free gum; it will help to return
to a normal bite.
Should you experience morning discomfort, seek the advice
of your Dental Healthcare Professional.
Tips for wearing your O2Vent Optima

16 OVENTUS
• 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 Optima 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
Contra-
indications
Risks and Contraindications

17OVENTUS
Recommended after each use
• Rinse the O2Vent Optima with lukewarm water and clean
with a soft clean toothbrush (not the same toothbrush
you use to brush your teeth, as toothpaste can damage
thedevice).
• Thoroughly rinse the device with lukewarm water, including
through the airway entry and exit points.
• Ensure the airway entry and exit are free from any debris.
• Dry your device after each cleaning with a cloth and shake
to clear water from the airway.
• Return to the Oventus tub to store, with the lid open to
allow the internal airway to dry.
O2Vent Optima cleaning instructions

18 OVENTUS
O2Vent Optima cleaning instructions
CONTINUED
Step 1
• Conduct the daily cleaning (refer to page 17).
Step 2
• Fill the Oventus tub provided about ¾ full (about ½” below
the top) with warm water.
• Place the antibacterial cleanser and the O2Vent Optima
device in the water so that they are completely submerged
and leave them to soak for 15 minutes if using the Oventus
provided tablets, or follow the recommended time according
to other antibacterial cleanser packet instructions.
Recommended cleaning twice a week
Clean your O2Vent Optima device more thoroughly twice
a week, or more frequently as required, using the provided
Oventus tub and an antibacterial cleanser (free from chlorine,
bleach, acetic acid or alcohol-based products).
Soaking O2Vent Optima twice a week