Oventus O2VENT OPTIMA User manual

ORAL APPLIANCE
FOR SLEEP APNEA
THERAPY
O2 VENT®
OPTIMA
INSTRUCTIONS FOR USE – USA

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

1
OVENTUS
INSTRUCTIONS FOR USE FOR O2 VENT®OPTIMA
CONTENTS
Introduction 2
Indications for use 3
Optima description 4
Your Optima kit 5
How your Optima device works 6
Using your Optima 9
Inserting your Optima 9
Removing your Optima 9
Finding the right titration setting 10
Tips for wearing your Optima 12
What are the risks of OSA 13
Contraindications 13
Cleaning instructions 14
General warnings and precautions 17
Maintenance 19
Replacing connector bands 20
Keep a log of your titration 21

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 (Optima) specically 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.

3
OVENTUS
INDICATIONS FOR USE
The 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.

4OVENTUS
Optima parts (before assembly):
lower tray, upper tray and connector bands
Optima (fully assembled)
Your Optima features the following components:
OPTIMA DESCRIPTION
Upper tray
with airway
Connector band
Lug for attaching
connector band
Lower tray

5
OVENTUS
YOUR OPTIMA KIT
Your customized Optima comes fully assembled with 19mm
length connector bands*. The Optima kit contains:
• Two sets of connector bands to adjust titration. Each set
of bands has 9 length size options ranging from 13-21mm.
The size is marked on the band.
• Oventus tub
• Instructions for use
• Warranty
• Antibacterial cleanser tablets
It is important that you check the contents of your
personalized 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.

6OVENTUS
HOW YOUR OPTIMA DEVICE WORKS
In general, the Optima works in the following way.
Provides a unique air channel
in case of nasal congestion
or diculties with breathing
through the nose.
Brings/pulls the lower jaw
forward (this opens the airway
and stabilizes the tongue)
The air channel allows the
air to ow smoothly to the
back of the airway.
1
3
2

7
OVENTUS
THE OPTIMA DEVICE
Air in on inhalation,
air out on exhalation
(together with nose)
Lower jaw adjustment helps
clear tongue obstruction
Connector band enables
adjustment to optimize treatment
Air channel at back of
device enabling air ow
Hollow airway bypasses
multiple obstructions
In order to make the Optima, an image of your teeth is taken
by the dentist. This image is sent to Oventus where your
customized Optima will be made. When the Optima is ready,
your Dental Healthcare Professional will t and assess how
well the Optima works to treat your snoring and/or OSA.
Hollow airway bypasses
multiple obstructions

8OVENTUS
The 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 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.
* In some instances, your Dental Healthcare Professional may
recommend a dierent starting length for your connector bands
based on your jaw anatomy.
HOW YOUR OPTIMA DEVICE WORKS CONTINUED

9
OVENTUS
The 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 Optima before using.
Loose bands may pose a chokingrisk.
INSERTING YOUR OPTIMA
BEFORE YOUR SLEEP PERIOD
1. Inspect your Optima; make sure the air channel is clear.
2. Make sure your Optima is connected with the bands and
they are the same length on each side.
3. Make sure your Optima is clean.
4. Rinse the 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 OPTIMA
AFTER YOUR SLEEP PERIOD
7. Remove your 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 OPTIMA

10 OVENTUS
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 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 Optima, you will
work closely with your Dental Healthcare Professional to
nd the correct position. ** It is important that you wear
your 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 10
for length and titration information.
• After your settings have been established, you should
wear your Optima each sleep period.
USING YOUR OPTIMA CONTINUED

11
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.
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
19mm
Advancement 6mmRetrusion 2mm
18mm20mm21mm 17mm 16mm 15mm 14mm 13mm

12 OVENTUS
It is important to use your Optima during each sleep period
to receive the best possible outcome.
TIPS
• If you are having problems adapting, try wearing your
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 Optima, this will help you to get into the habit of
applying your Optima before your sleep period. Refer to
page 21 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 OPTIMA

13
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 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

14 OVENTUS
RECOMMENDED AFTER EACH USE
• Rinse the 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.
OPTIMA CLEANING INSTRUCTIONS

15
OVENTUS
Step 1
• Conduct the daily cleaning (refer to page 14).
Step 2
• Fill the Oventus tub provided about ¾ full (about ½”
below the top) with warm water.
• Place the antibacterial cleanser and the Optima device
in the water so that they are completely submerged and
leave them to soak, following the recommended time
according to the cleanser packet instructions.
RECOMMENDED CLEANING TWICE A WEEK
Clean your 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 Optima twice a week

16 OVENTUS
• Remove and rinse both the Optima device and Oventus
tub thoroughly with lukewarm water, including through the
airway entry and exit points, to remove the cleaning agent.
• Dry your device after each cleaning with a clean cloth.
• Return to the Oventus tub to store, with the lid open to
allow the internal airway to dry.
After soaking the Optima device with an antibacterial
cleanser, remove device promptly and rinse thoroughly
with lukewarm water. Wash hands thoroughly before
and after handling cleanser tablets. Do not mix with
other cleansers.
Antibacterial cleansers contain persulfates which are a
known allergen. Keep out of reach of children. Use only
as directed. If product comes into contact with eyes,
wash eyes thoroughly with water for several minutes.
Do not put antibacterial cleanser tablets or cleaning
solution in mouth. If ingested, seek medical assistance
immediately. In the USA, please call Poison Control
Center at 1-800-222-1222.
OPTIMA CLEANING INSTRUCTIONS CONTINUED

OVENTUS 17
GENERAL WARNINGS AND PRECAUTIONS
Use of the Optima may cause the following side eects:
• Tooth movement, discomfort, pain or changes in
dental occlusion
• Dental soreness
• Pain or soreness to the temporomandibular joint (TMJ)
• Excessive salivation
• Cheek or tongue pain
• Jaw discomfort, pain or jaw set (clenched jaw)
• Temporary bite change. This will subside approximately
30minutes after the Optima is taken out of the mouth
after each sleep period
• Permanent bite change may occur as a result of long
termuse
• Gingivitis. This is a common and mild form of gum disease
(periodontal disease) that causes irritation, redness and
swelling (inammation) of your gingiva, the part of your
gum around the base of your teeth. Untreated gingivitis
can progress to gum disease that spreads to underlying
tissue and bone. This is known as Periodontitis, a much
more serious condition that can lead to tooth loss. Should
you experience any of these symptoms, seek the advice of
your Dental HealthcareProfessional.
• Dry mouth. This is a common side eect of using the
Optima device. Dry mouth can lead to gum disease such as
gingivitis. Should you experience this symptom, seek the
advice of your Dental Healthcare Professional.
If any side eects or ongoing dental issues persist while
using the Optima, please seek advice from your Dental
HealthcareProfessional.

OVENTUS
18
GENERAL WARNINGS AND PRECAUTIONS
PRECAUTIONS:
• Dental 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 prescribing theOptima device
• Never use chlorine, bleach, acetic acid or alcohol-based
products (including mouthwash) to clean your Optima
• Only use warm water, not to exceed 45°C or 113°F (boiling
water may cause damage)
• Do not use toothpaste or mouthwash to clean your Optima
• If you require dental work such as llings, crowns,
extractions etc., these may change the t of your
Optima. You should always discuss this with your Dental
Healthcare Professional
• The Optima may change color over time, which could
be due to certain foods/liquids. This will not change the
eectiveness of the device. If you use colored mouthwash
after cleaning your teeth, wait 15 minutes before inserting
your Optima, to avoid discoloration. For best results, follow
the recommended cleaning instructions.
• The 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 Optima before using. Loose bands may
pose a chokingrisk.