Airway flexTAP Manuel utilisateur
MOUTH SHIELD
Instruction for Use
Introduction
Due to airflow through the mouth, some patients experience
dry mouth and or excessive saliva leading to mild discomfort
when using an oral appliance. Furthermore, the flexTAP™ post
may pose some discomfort. The flexTAP™ Mouth Shield has
been designed to reduce oral breathing therefore lessening the
drying eect and/or excessive saliva that oral breathing can
have. It can also act as comfort sleeve for the flexTAP™ post.
The flexTAP™ post is inserted into the Mouth Shield and sits
inside the lips.
Use of the Mouth Shield should be discontinued if nausea,
nasal congestion, or any condition that would decrease or
prevent breathing through the nose occurs.
Warnings
Use of the Mouth Shield should be discontinued if nausea, nasal
congestion, or any condition that would decrease or prevent
breathing through the nose occurs.
Discontinue use if reaction occurs and consult prescriber.
Discontinue use if experiencing discomfort and consult
prescriber.
Mouth Shield is single patient use.
Discontinue use if damaged or deteriorated and seek
replacement.
Do not use if vomiting or feeling nauseous.
Do not use if patient is unable to remove by themselves.
Use on adults only (>66lb/30kg).
Do not misuse the Mouth Shield.
Do not store or transport the Mouth Shield outside temperature
range -4°F to 122°F (-20°C to 50°C)
Operating temperature range of the Mouth Shield is 40°F to
105°F (5°C to 40°C)
Do not store in direct sunlight.
Do not wash in dishwasher.
Do not clean in products that contain chlorine, bleach,
moisturizer, antiseptic, anti-bacterial agents, or alcohol.
Watch Video Scan QR code for videos and more
information on Mouth Shield.
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PRTD170 REV A, 2022
Patents:
http://tapintosleep.com/patents
4300 Alpha Rd, Suite 115
Farmers Branch, TX 75244
Tel: (866) 264-7667
Fax: (214) 691-3151
Email: contactami@amisleep.com
Website: www.tapintosleep.com
Manufacturer
Airway Management Contacts
Intended Use
The flexTAP™ Mouth Shield is an optional comfort accessory to
be used with the flexTAP custom oral appliance to prevent
drying and/or excess saliva of the mouth while wearing the
flexTAP. It is intended for single patient adult use.
Disposal
The flexTAP Mouth Shield may be placed in the general
household receptacle.
Operating Instructions
The flexTAP Mouth Shield should be placed over the post with
the center divot facing up or towards the upper tray. As the
Mouth Shield is designed to allow for the lower tray to be more
advanced, it is important to position it correctly on your
flexTAP.
The Mouth Shield should be pushed firmly over the dial and
post so it “clips” into place and rests against the flexTAP trays.
The Mouth Shield should rest comfortably in your mouth,
between your teeth and the inside of your lips/cheeks. If it
feels bulky, you may want to check that it is fully inserted on
the flexTAP in the correct position.
The Mouth Shield can be trimmed to maximize comfort and fit.
The Mouth Shield may include side bite tabs/ posterior pads.
These tabs can assist with maintaining tray retention and
increasing the vertical position of the flexTAP. The tabs can be
removed if preferred.
The Mouth Shield should be removed from the appliance and
cleaned daily by running it under hot water and leaving it to air
dry out of direct sunlight. It can also be cleaned using a mild
soap and warm water solution. Inspect for signs of damage
daily and replace immediately if showing signs of wear.
Cleaning
Operating Instructions [Continued]
Adjustment of the flexTAP must be made before applying the
flexTAP Mouth Shield. The Mouth Shield can also be removed if
further adjustments need to be made.
Use of the Mouth Shield should be discontinued if nausea, nasal
congestion, or any condition that would decrease or prevent
breathing through the nose occurs. The Mouth Shield should be
replaced if it shows signs of tearing or deterioration. The Mouth
Shield should be replaced at least yearly.
Note: Failure to follow instructions may compromise the
performance of the Mouth Shield.
Do not store in direct sunlight.
Do not wash in dishwasher.
Do not clean in products that contain chlorine, bleach,
moisturizer, antiseptic, anti-bacterial agents or alcohol.
Do not soak the Mouth Shield in cleaning solutions for more
than 10 minutes per day.
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