ExVent IFU-5 V2.0 Open airway Dental Solutions Instruction Manual

ExVent IFU-5 V2.0 Open airway Dental Solutions Instruction Manual

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.

Figure 1: ExVent – breathing in

Upon breathing in, the ExVent’s valve fully opens which allows for the free flow 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.

The ExVent offers three different 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.

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 fitted 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.

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 find breathing out through a particular strength difficult, 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 fingers in the middle as shown.
2. Ensure that the ExVent valve (that opens and closes) is lying flat 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.
   

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 flat against the body of the ExVent. Use a new ExVent** if necessary.

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 case that is provided with the O2Vent Optima device

• Leave the ExVent to dry in a well-ventilated area.
  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.

Tips for use:

1. If you are finding it uncomfortable or difficult 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.

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).

• Single patient multiple use.
• 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.

ExVent potential side effects

The most commonly experienced side effects may include:

• Dry mouth/throat/lips
• Nasal congestion/runny nose
• Throat or ear discomfort
• Breathing discomfort
• Headache
• Difficulty falling asleep and staying asleep.

Warning:

• If you experience difficulties with your ExVent and/or O2Vent Optima, contact your prescribing Healthcare Professional.
• Follow-up testing and evaluation should be conducted to ensure treatment effectiveness.

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.

ExVent Product Codes:

MANUFACTURER AND AUSTRALIAN SPONSOR:
Open Airway Dental Solutions Pty Ltd, Australia 5 Moorak Street, Taringa QLD 4068 Australia
www.openairway.au
info@openairway.com
Ph: +61-1300-533-159

MANUFACTURED FOR:
Open Airway Dental Solutions Ltd, Canada
www.openairway.ca
Ph: +1-877-977-8267

References

• openairway
• Openairway - Oventus – openairway

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