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 safety and maintenance 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 device has been prescribed by your dentist. Carefully follow all instructions and exercises as directed to achieve the best possible results in the shortest amount of time.

Before using this device, make sure you do not have any known allergies or hypersensitivity to any of the materials used in it.
If you experience an allergic reaction, stop using this product and contact your dentist.
Applying excessive force to the Eptamed Training Appliance may 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 current regulations regarding waste disposal.
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 Device from its case before placing it between your teeth, and perform the exercise prescribed by your dentist based on the condition diagnosed.

If you experience any problems while using this product, such as pain, inflammation, or swelling of the gums, discontinue use and consult your healthcare provider.

Dosage

A healthcare professional will specify the duration and method of use. Normally, the Eptamed Eq. Training device should be used for at least 1 hour during the day.

Exercises

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

Age Range

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

Contraindications

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

Always consult your healthcare provider before using this product.

Maintenance

The Eptamed Training machine 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.

Gently blot the device with paper towels or a clean towel, and then let it air dry completely before storing it in its case.

Color variations do not affect the device’s functionality.

Substitution Criteria

The professional will determine whether it is necessary to replace the Eptamed Training device and when to do so.

It is generally recommended to replace it once a previously established therapeutic goal has been achieved. It is advisable to replace the device when structural changes caused by chewing may compromise its performance.