SICAT OPTISLEEP User manual

Application and care information

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Dear OPTISLEEP users,
You know that feeling, tiredness and exhaustion dictate your daily routine. The doctor's
diagnosis is that you suffer from snoring or even obstructive sleep apnea.
Your dentist had an OPTISLEEP therapeutic appliance ordered for you individually. This
means that you are already holding the solution in your hands.
OPTISLEEP reduces and alleviates snoring and/or mild to moderate obstructive sleep
apnea (OSA) among adults (from the age of 18) as they sleep.
These instructions provide you with information about the treatment with OPTISLEEP,
describes the use of the appliance as well as provides important tips on cleaning and
caring for your new therapeutic appliance.
Should you have any questions in relation to your OPTISLEEP therapeutic appliance,
please contact your dentist.
Your OPTISLEEP team
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THE OPTISLEEP TREATMENT
The OPTISLEEP therapeutic appliance works in accordance with the mandibular-pro-
trusion principle:
The therapeutic appliance is worn in the mouth while sleeping and holds the lower jaw
in a slightly pulled-forward treatment position.
This results in a widening of the respiratory tract and at the same time activates the
muscles of the tongue and soft tissue providing additional stability to the airway. This
reduces snoring noises and the respiratory tract remains open.
blocked respiratory tract free respiratory tract thanks to OPTISLEEP
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THE OPTISLEEP THERAPEUTIC APPLIANCE
The therapeutic appliance was individually created for you and consists of
■a splint for the upper jaw,
■a splint for the lower jaw,
which are connected by interchangeable connector pairs. These are available in differ-
ent lengths so that your dentist can adjust the position of the lower jaw to the best pos-
sible position during the course of treatment.
CAUTION!Federal Law (USA) restricts use of this device to or on the order of a physi-
cian, dentist or licensed practitioner.
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USING THE OPTISLEEP THERAPEUTIC APPLIANCE
Fitting of the therapeutic appliance
Perform the first fitting of the therapeutic appliance in the presence of your dentist.
Inserting the therapeutic appliance
Before using the therapeutic appliance, ensure that the connectors have been correctly
fitted.
Slide the therapeutic appliance into the mouth completely. First, place the lower jaw
splint and then the upper jaw splint on the teeth by applying a little pressure. The splint
snaps onto the teeth and should stay securely in place.
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Do not attempt to attach the appliance forcibly. If you encounter problems insert-
ing the appliance, consult your dentist.
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Removing the therapeutic appliance
It should be possible to remove the therapeutic appliance from your teeth by exerting a
slight amount of force.
Place your thumbs on the lower splint in the area of the molars on both sides and lever
these upward with equal slight pressure. Then carefully pull the upper splint from the
teeth.
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Adjusting the treatment position
The OPTISLEEP therapeutic appliance can be set to one of a total of 10 different treat-
ment positions using connectors of various lengths.
Your dentist has provided you with a therapeutic appliance which has already been set
to the correct treatment position. Do not change the position without consulting your
dentist first!
Removing the connectors
The connector is connected with both the upper and lower jaw splint with holding pins.
In order to remove the connector, it has to be positioned perpendicular to the splint
so that the fastener for removing the connector is released. The connector can only be
removed when in this position!
After you have positioned the connector perpendicularly, remove it by pulling via the
holding pin. Hold the splint with your other hand to stabilize it at the height of the hold-
ing pin.
Holding pin Connector
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Securing the connector
The connector is connected with the upper and lower jaw splint via holding pins.
In order to secure a connector in place, this needs to snap into the holding pin of the
splint. To do this, apply slight pressure and guide the long hole of the connector per-
pendicularly to the splint via the holding pin. The connector then snaps into place with
a click.
When securing the connector, please make sure that you hold the splint below the
holding pin with the other hand in order to prevent the splint from being overly
strained.
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CLEAN AND CARING FOR YOUR OPTISLEEP THERAPEUTIC APPLIANCE
■Always brush your teeth thoroughly prior to inserting the therapeutic appliance.
■Clean the therapeutic appliance thoroughly every morning after removing it, using a
soft toothbrush under lukewarm flowing water. You should use this toothbrush ex-
clusively for cleaning your OPTISLEEP therapeutic appliance. You can clean your
therapeutic appliance occasionally with a mild detergent (e.g. dishwashing liquid) or
a mild oxygen-free denture cleaner.
■After cleaning the OPTISLEEP therapeutic appliance, always store it in the provided
storage container in a cool and dry place at room temperature.
■Protect the therapeutic appliance from direct sunlight and heat.
■Remove the therapeutic appliance before eating or drinking in order to avoid dam-
aging it.
Warnings relating to care
The use of denture cleaners which contain oxygen could result in the plastic in your
therapeutic appliance becoming permanently damaged. The use of hot water and
toothpaste could result in damage. Altering the therapeutic appliance yourself could
lead to damage or a risk of injury. Incorrect cleaning may lead to loss of warranty.
Damaged therapeutic appliances
Regularly inspect your therapeutic appliance for damages. Examples of such damage
include deformations, cracks, breaks, or loose parts.
A damaged or broken therapeutic appliance may no longer be used due to the risk of
injury. Should this indeed happen, please contact your dentist immediately.
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WARRANTY
Your OPTISLEEP therapeutic appliance was produced for you individually in a fully-di-
gitalized process using your 3D picture data.
Even though the digital planning and production of OPTISLEEP guarantees the greatest
possible accuracy, it can nevertheless not be guaranteed that the therapeutic appli-
ance will definitely stop the snoring and/or reduce the obstructive sleep apnea (OSA).
We recommend that you have your therapeutic appliance checked by your dentist at
regular intervals.
The manufacturer provides you with a warranty for your OPTISLEEP therapeutic appli-
ance covering any manufacturing faults and material defects over the entire life span of
the therapeutic appliance of 2 years. Please do not use your therapeutic appliance after
the end of its life span.
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INDICATIONS FOR USE AND CONTRAINDICATIONS
Indications for use
The OPTISLEEP therapeutic appliance is indicated for use in adults to
■to reduce or alleviate snoring and
■to reduce or alleviate mild to moderate obstructive sleep apnea
Contraindications
The OPTISLEEP therapeutic appliance may not be used in the following cases:
■Central sleep apnea
■Loose teeth
■Advanced periodontitis
■Persons under 18 years
■Toothless jaw
■Severe respiratory diseases
Possible side effects
Wearing the therapeutic appliance can lead to increased salivation. Pain in the jaw
joints and muscles, the palate, gums and the teeth, as well as headaches can also occur
temporarily.
If mild physical discomfort persists, please contact your dentist.
Under certain circumstances, long-term effects could be movement of the teeth or
changes to the dental occlusion.
In the event of any type of severe pain, respiratory problems, nausea, allergic reactions
or tooth movements, remove the splint and contact your dentist immediately.
We recommend regular checkups with your dentist!
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Your OPTISLEEP therapeutic appliance
will be given to you by your dentist in the
OPTISLEEP storage container.
Always store the therapeutic appliance in
the OPTISLEEP storage container cleaned
and dried following each use.
Please contact your dentist regarding the
proper disposal of your OPTISLEEP.
If serious incidents (such as severe injur-
ies) occur in connection with the product,
these must be reported to the manufac-
turer and the competent authority.
If you should have any questions or sug-
gestions with respect to your OPTISLEEP
therapeutic appliance, please visit our
website:
WWW.OPTISLEEP.COM
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NOTES
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10470EN | 500204 | DD32IFU012 - 2020-03-27
Manufacturer
SICAT GmbH & Co. KG - Friesdorfer Str. 131-135 - 53175 Bonn, Germany
WWW.OPTISLEEP.COM
PRACTICE / INFORMATION
Federal Law (USA) restricts use of this device to or on the order of a physician, dentist or
licensed practitioner.