Medical device

Eq. Training Eptamed

Package Insert — Instructions for Use

General Information

Please read the following instructions carefully before using the product.

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

Intended Use

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

Warnings

Eptamed Eq. Training has been prescribed for you by your dentist. Carefully follow all the instructions and exercises provided to achieve the best possible results in the shortest amount of time.

Before use, 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 product and contact your dentist.
Tightening the Eptamed Training Brace too tightly can cause it to break partially or completely. If this happens, stop using it and consult your dentist.
When disposing of the device, strictly comply with applicable waste disposal regulations.
Any serious incident involving 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.

Instructions for Use

Remove the Eptamed Training Appliance from its case before placing it between your teeth and performing the exercise prescribed by your dentist based on the specific issue identified.

If you experience any problems while using this product—such as pain, inflammation, or swelling of the gums—stop using it and consult your healthcare professional.

Dosage

Your healthcare professional will specify the duration and method of use. Normally, the Eptamed Eq. Training 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.

Age Range

Eptamed Eq. Training can be used by children ages 5 and up.

Contraindications

The use of the Eptamed Equ. Training device should be carefully evaluated in cases of loose teeth, advanced periodontal disease, temporomandibular joint pain, or dental implants.

Always consult your healthcare professional before use.

Maintenance

The Eptamed Eq. Training device must be cleaned after each use with running water and, if necessary, with a specific cleaning product such as EptaClean.

Carefully remove any saliva residue using a toothbrush, if necessary.

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

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

Replacement Criteria

A healthcare professional will determine if and when to replace Eptamed Eq. Training.

Generally, replacement is recommended once a predetermined therapeutic goal has been achieved. It is advisable to replace the device if structural changes caused by chewing could compromise its performance.