INSTRUCTIONS FOR USE – AUSTRALIA
O
2
VENT
OPTIMA
™
ORAL APPLIANCE
FOR SLEEP APNOEA
THERAPY
Name of User
Name of Sleep Physician
Name of Dentist
Serial No. of Device
Date of first fitting/purchase
Connector band starting titration length
Date of follow up with Physician/Dentist
INSTRUCTIONS FOR USE FOR O
2
VENT OPTIMA
™
CONTENTS
Introd uction
Optima Description
Your Optima kit 4
How Your Optima Device Works 5
Using your Optima
Inserting your Optima
8
8
2
3
Removing your Optima 8
Finding the right titration setting 9
What are the Risks of OSA 11
Contraindications
Cleaning Instructions
11
12
General Warnings and Precautions 14
Maintenance 15
Replacing connector bands
Keep a Log of your Titration
16
17
OVENTUS
1
INTRODUCTION
Congratulations, you have taken the first steps to improve your sleep and well-being!
Your Healthcare Professional has chosen the
O
2
Vent Optima™ ( Optima ) specifically for your snoring and/or obstructive sleep apnoea (OSA) therapy. OSA is a condition where a sufferer 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 fitted 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.
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OVENTUS
OPTIMA
DESCRIPTION
Your Optima features the following components:
Optima parts (before assembly): lower tray, upper tray and connector bands
Upper tray with airway
Lug for attaching connector band
Lower tray
Connector band
Optima (fully assembled)
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3
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 find everything listed above. Please contact your Healthcare
Professional if anything is missing.
* In some instances, your Healthcare Professional may recommend a different starting length for your connector bands based on your jaw anatomy.
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HOW YOUR
OPTIMA
DEVICE WORKS
In general, the Optima works in the following way.
1 Brings/pulls the lower jaw forward (this opens the airway and stabilises the tongue)
2
Provides a unique air channel in case of nasal congestion or difficulties with breathing through the nose.
3
The air channel allows the air to flow smoothly to the back of the airway.
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5
HOW YOUR
OPTIMA
DEVICE WORKS
CONTINUED
THE OPTIMA DEVICE
Hollow airway bypasses multiple obstructions
Hollow airway bypasses multiple obstructions
Air channel at back of device enabling air flow
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
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 fit and assess how well the Optima works to treat your snoring and/or OSA.
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HOW YOUR
OPTIMA
DEVICE WORKS
CONTINUED
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 specific needs, the bands come in different 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 find the right length of connector bands to receive the best therapy.
* In some instances, your Healthcare Professional may recommend a different starting length for your connector bands based on your jaw anatomy.
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USING YOUR
OPTIMA
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 fit snugly.
6. Insert the lower tray, “push” onto the lower teeth; the tray should fit 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.
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The Optima trays should never be worn separately.
Always wear both trays (assembled with the connector bands) when using the device.
FINDING THE RIGHT TITRATION SETTING
• Your Optima will be delivered ready to use, fitted 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 find 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 different starting length for your connector bands based on your
jaw anatomy.
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USING YOUR
OPTIMA
CONTINUED
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
Starting band titration
Longer length band = less advanced jaw
Shorter length band = further advanced jaw
21mm 20mm 19mm 18mm 17mm 16mm 15mm 14mm 13mm
Minimum lower jaw advancement
Retrusion 2mm Advancement 6mm
Maximum lower jaw advancement
Titration length range: 13-21mm. The shorter the connector band length, the further the lower jaw is moved forward
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.
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WHAT ARE
THE RISKS
OF OSA?
• Detrimental effects 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
It is important to use your Optima during each sleep period to receive the best possible outcomes.
CONTRA-
INDICATIONS
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
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OPTIMA
CLEANING INSTRUCTIONS
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.
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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 effectiveness 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.
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GENERAL WARNINGS AND PRECAUTIONS
Use of the Optima may cause the following side effects:
• 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 effects 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 fillings, crowns, extractions etc., these may change the fit of your
Optima . You should always discuss this with your
Healthcare Professional
• The Optima trays should never be worn separately
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GENERAL WARNINGS AND PRECAUTIONS 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 affect the band length and the titration of your device. The connector bands should be replaced every month or more frequently if required.
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15
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 off 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.
Wider end of lug
Pointed end of lug
Separate upper and lower device parts as shown to remove connector bands
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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 first 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
19mm EXAMPLE:
1 Sep 2018
EXAMPLE:
8 Sep 2018
EXAMPLE:
22 Sep 2018
18mm
17mm
After 1 week wearing, still snoring, some dribble.
Changed to shorter band
Still snoring, less dribble. Changed to shorter band
Worn for 2 weeks. No snoring. Dribble stopped
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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: (+61) 1300 533 159
(Toll free only in Australia) [email protected] www.oventus.com.au
PRODUCT CODE: O2VB R58_Sep 2018
