Medical device

Eptamed Lingual Equation

Package Insert — Instructions for Use

General Information

Read this package insert and the enclosed instructions carefully before using the product.

Failure to follow the safety and storage instructions may result in harm to human health and the environment.

Description

The Eptamed Lingual Device is a medical device supplied in a non-sterile package that gently acts on the structure of the oral cavity, improving the functions that take place there: swallowing, breathing, chewing, and speech.

Warnings

Eq. Linguale was prescribed for you by a specialist, so we recommend that you carefully follow all the instructions and exercises they provide in order to achieve the best possible results in the shortest amount of time.

Before use, make sure you do not have any specific allergies to the material.
In the extremely rare event that allergic reactions occur, discontinue use and contact your healthcare provider.
When disposing of this product, strictly follow the current regulations regarding waste disposal.
This instruction manual must be kept for the entire duration of the product’s use.
Keep the product and the manual out of the reach of children.
In the highly unlikely event that a serious accident occurs in connection with the use of this device, it must be reported to the manufacturer and to the competent authority of the Member State in which the user is located.

Operating Instructions for Use

The specialist selects the size of the Eptamed Lingual Appliance that best suits the patient. Remove the Eptamed Lingual Appliance from its storage case and place it between your lips; it must never extend beyond the edge of your teeth. It is essential to breathe through your nose, which is why the device has no openings for breathing through the mouth. This may seem difficult at first, but as the days go by, it will become increasingly natural and easy.

This device is intended for use by a single person during treatment and must be discarded at the end of the treatment.

Dosage

The specialist will determine how long to use it. Normally, the Eptamed Lingual Device should be worn for 5 minutes a day for the first 7 days, focusing on swallowing and nasal breathing. After 7 days, the device should be worn passively for 1 hour a day. With the cord attached, the Niki 1 can also be used for strengthening exercises. When used by children, adult supervision is recommended. The device must NEVER be worn while sleeping at night or during the afternoon.

The treatment lasts for a maximum of 3 months.

Age Range

The ideal age for achieving the best results with the Eptamed Lingual Braces is between 3 and 7 years old. Although excellent results can still be achieved after age 7, treatment typically takes longer. There are no age limits for using the Eptamed Lingual Braces.

Contraindications

No side effects have been identified. Excessive use or the use of a device not intended for the patient undergoing treatment may lead to complications in the oral cavity.

This device is not intended for use by children under 3 years of age.

Maintenance

The quality of the material used and its soft shape make it easy to clean; it should always be cleaned before each use by rinsing it with water or, for a more thorough cleaning, using specific natural cleaning products.

Always make sure that the hygiene conditions under which you store your Eptamed Lingual Braces are appropriate for your intended use; avoid introducing dirt and germs into your mouth through the braces, always handle them with clean hands, and store them properly.

Replacement Criteria

This therapy should be continued for a maximum of 3 months. If this initial phase proves insufficient, your specialist will supplement the therapy with specific, targeted exercises tailored to your age and the nature of your condition.

Storage

Store the Eptamed Lingual Brace in a dry, clean place away from heat sources or direct sunlight. Do not allow it to come into contact with citrus fruits or essential oils, which could stain it. Finally, be careful with pets, as they may be particularly attracted to the device.

Materials Used

The Eptamed Lingual Brace is manufactured from a biocompatible polypropylene-based plastic certified for medical use.

Expiration Date

If stored in its original packaging and in an environment suitable for long-term storage, the device can be used for up to 5 years. Once it has been placed in the mouth, the need for replacement must be assessed by a specialist and carried out within 3 months.