Medical device

Eptamed Training Equipment

Package Insert — Instructions for Use

General Information

Please read the following instructions carefully before using the product.

Failure to follow the safety and storage warnings may pose risks to health and the environment.

Intended Use

The Eptamed Training Device is a non-sterile medical device intended for the treatment of disorders of mandibular and oromasticatory function.

Warnings

The Eptamed Training Kit has been prescribed for you by your dental professional. Please follow all instructions and exercises carefully to achieve the best results in the shortest time possible.

Before using the device for the first time, make sure you do not have any known allergies or hypersensitivity to any of the materials used in the device.
If you experience an allergic reaction, stop using the device immediately and contact your dentist.
Tightening the Eptamed Training device too much may cause it to break, either partially or completely. If this happens, stop using the device and consult your dentist.
When disposing of the device, strictly follow the applicable regulations on waste disposal.
Any serious incident related to the use of the device must be reported to the manufacturer and to the competent authority of the Member State in which the user and/or patient is located.

User Instructions

Please remove the Eptamed training device from its case before placing it between your teeth and performing the exercise recommended by your dental professional based on the specific issue identified.

If you experience any problems while using the appliance, such as pain, inflammation, or swelling of the gums, stop using it immediately and consult your dentist.

Wear Schedule

Your dental professional will advise you on how long to use the device and how to use it. Normally, the Eptamed Training Device should be used during the day for at least 1 hour.

Exercises

The exercises associated with Eptamed products are available in the MyEptamed app, which you can download to your device.

Recommended age range

Eptamed Training is suitable for children ages 5 and older.

Contraindications

Eptamed Training must be carefully evaluated in cases of tooth mobility, advanced periodontal disease, temporomandibular joint pain, or dental implants.

Always consult your dentist before use.

Maintenance

The Eptamed training equipment must be cleaned after each use under running water and, if necessary, with a specific cleaning product such as EptaClean.

If necessary, please carefully remove any saliva residue using a toothbrush.

Dry the device by dabbing it with paper towels or a clean towel, then let it air dry completely before storing it in its case.

Variations in color do not affect the device’s effectiveness or functionality.

Conditions for Replacement

Your healthcare professional will determine whether and when to replace the Eptamed training device.

Typically, replacement is recommended once a predetermined therapeutic goal has been achieved. It is advisable to replace the device if structural changes caused by chewing are likely to affect its effectiveness.