Oventus O2Vent, Optima Instruction Manual

ORAL APPLIANCE

FOR SLEEP APNOEA

THERAPY

O2VENT

OPTIMA

™

INSTRUCTIONS FOR USE – AUSTRALIA

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 O2VENT OPTIMA

™

CONTENTS

Introduction 2

Optima Description 3

Your Optima kit 4

How Your Optima Device Works 5

Using your Optima 8

Inserting your Optima 8

Removing your Optima 8

Finding the right titration setting 9

What are the Risks of OSA 11

Contraindications 11

Cleaning Instructions 12

General Warnings and Precautions 14

Maintenance 15

Replacing connector bands 16

Keep a Log of your Titration 17

2

OVENTUS

INTRODUCTION

Congratulations, you have taken the rst steps to
improve your sleep and well-being!

Your Healthcare Professional has chosen the
O2Vent Optima™ (Optima) specically for your

snoring and/or obstructive sleep apnoea (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.

The Optima is a removable oral appliance that is
tted in the mouth and is intended to reduce or
alleviate snoring and mild to moderate OSA. The
Optima is indicated for use during sleep to aid in the
treatment of these conditions. Intended for adult
patients 18 years or older. The Optima device is for
prescription use only.

3

OVENTUS

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

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YOUR OPTIMA KIT

Your customised 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
personalised Optima kit and make sure that you nd
everything listed above. Please contact your Healthcare
Professional if anything is missing.

*

In some instances, your Healthcare Professional may recommend a

dierent starting length for your connector bands based on your
jaw anatomy.

5

OVENTUS

HOW YOUR OPTIMA DEVICE WORKS

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 stabilises the tongue)

The air channel allows the
air to ow smoothly to the
back of the airway.

1

2

In general, the Optima works in the following way.

3

6

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 optimise treatment

Air channel at back of

device enabling air ow

Hollow airway bypasses

multiple obstructions

In order manufacture the Optima, an image of the teeth
using 3D scanning or impressions are taken. The information
is sent to a laboratory where your customised Optima
will be made. When the Optima is ready, your Healthcare
Professional will t and assess how well the Optima works to
treat your snoring and/or OSA.

Hollow airway bypasses

multiple obstructions

HOW YOUR OPTIMA DEVICE WORKS CONTINUED

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The Optima consists of the following parts:

• 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 Healthcare Professional will

help you to nd the right length of connector bands to

receive the best therapy.

*

In some instances, your Healthcare Professional may recommend a

dierent starting length for your connector bands based on your
jaw anatomy.

The Optima trays should never be worn separately.
Always wear both trays (assembled with the
connector bands) when using the device.

8

OVENTUS

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

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FINDING THE RIGHT TITRATION SETTING

• 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 Healthcare Professional to nd
the correct position. ** It is important that you wear your
Optima each sleep period according to your 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 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.

*

In some instances, your Healthcare Professional may recommend

a dierent starting length for your connector bands based on your
jaw anatomy.

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USING YOUR OPTIMA

CONTINUED

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.

The table below shows the lower jaw positioning range that
can be set by the connector band lengths. This is a guide only.

The recommended starting titration for new users in most
instances is the 19mm connector bands.

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

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• 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 apnoea

• Have severe respiratory
disorders

• Have loose teeth or
advanced periodontal
disease or restorative needs

• Are under 18 years of age

CONTRA-

INDICATIONS

It is important to use your Optima during each sleep period
to receive the best possible outcomes.

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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 clean tissue or

towel 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.

RECOMMENDED 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).

• Conduct the daily cleaning as above.

• Fill the Oventus tub provided about ¾ full (about 10mm

below the top) with warm water.

OPTIMA CLEANING INSTRUCTIONS

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• 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.

• 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.

• The Optima may change colour over time, which could

be due to certain foods/liquids. This will not change
the eectiveness of the device. If you use coloured
mouthwash after cleaning your teeth, wait 15 minutes
before inserting your Optima, to avoid discolouration. For
best results, follow these provided cleaning instructions.

14

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GENERAL WARNINGS AND PRECAUTIONS

Use of the Optima may cause the following side eects:

• Tooth movement, discomfort, pain or changes in
dental occlusion

• Gum irritation, gingival or dental soreness

• Pain or soreness to the temporomandibular joint (TMJ)

• Dry mouth or 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

If any side eects or ongoing dental issues persist while using the
Optima, please seek advice from your Healthcare Professional.

PRECAUTIONS:

• 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
Healthcare Professional

• The Optima trays should never be worn separately

15

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MAINTENANCE

Your Optima should be 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.

Once you have determined the band length that optimises
your therapy, you can re-order them in packs of 25. To re­order the connector bands, ask your Health Professional or

visit www.oventus.com.au

The Optima connector bands have a recommended usage
time frame of one month, as usage can aect the band length
and the titration of your device. The connector bands should
be replaced every month or more frequently if required.

16

OVENTUS

REPLACING CONNECTOR BANDS

The connector bands are essential for keeping your Optima
device assembled, with the lower jaw set at the chosen
position eg. with 19mm bands. The connector bands need to
be replaced every month as they may lose elasticity. To identify
when both bands need changing, compare their length against
a new band. If the bands are longer or the holes stretch from
circular to oval, it is time to change both bands.

To remove a connector band from your Optima device,
pull the upper and lower device pieces apart (as shown in
diagram). Peel the band away from the wider end of the “lug”
and o the “lug” point.

To apply a connector band, hook the band over the pointed end
of the “lug” and pull gently to hook over the wider “lug” end.

Pointed

end of lug

Separate upper

and lower device

parts as shown

to remove

connector bands

Wider
end of lug

17

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KEEP A LOG OF YOUR OPTIMA TITRATION

It is recommended that you keep a usage log of your Optima
titration setting for the rst month of wear (recording which
length connector bands you try, to advance your lower jaw).
Your entry may be weekly or daily. It may take several weeks
or longer to achieve the best therapy. Refer to page 10 for
the lower jaw positioning range as a guide.

Date

Connector
band length

Comment

EXAMPLE:
1 Sep 2018

19mm After 1 week wearing, still snoring, some dribble.

Changed to shorter band

EXAMPLE:
8 Sep 2018

18mm Still snoring, less dribble. Changed to shorter

band

EXAMPLE:
22 Sep 2018

17mm Worn for 2 weeks. No snoring. Dribble stopped

PRODUCT CODE: O2VB R58_Sep 2018

WARRANTY:

Please see the Oventus Warranty Policy Card
included with your device.

MANUFACTURER AND AUSTRALIAN SPONSOR:

Oventus Manufacturing Pty Ltd
1 Swann Road, Indooroopilly,
QLD, 4068, Australia

Ph: ([phone]
(Toll free only in Australia)

[email protected]
www.oventus.com.au