Medical device

Eptamed Nasal Spray

Package Insert — Instructions for Use

Nasale ist

General Information

Read this package insert and the enclosed instructions carefully before using the product. Failure to follow the safety and storage precautions may result in harm to human health and the environment.

Intended Use

The Eptamed Nasal Eq. is a medical device supplied in a non-sterile package that is designed to promote proper nasal breathing.

Warnings

Eq. Nasale was prescribed to you by your specialist, so we recommend that you follow the instructions provided in order to achieve the best results.

  • 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.
  • When disposing of this product, strictly follow the current regulations regarding waste disposal.
  • 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.
  • This instruction manual must be kept for the entire duration of the product’s use.

Operating Procedure by the Specialist

The Nasal Eq. is available in five sizes: XS, S, M, L, XL. Each size is obtained by trimming the excess material, thereby adapting it to the user’s specific needs. We recommend carefully rounding off the edges of the cut using a heated utility knife to prevent irritation of the nasal mucosa.

  • Size XS: Exclude sizes XL, L, M, and S
  • Size S: Exclude sizes XL, L, and M
  • Size M: Exclude the XL and L sizes
  • Size L: Discard only the XL portion
  • Size XL: Leave the device as is

Next, insert the Nasal Eq. into the nose, applying gentle pressure so that it fits snugly into the nasal passages (we recommend inserting a larger size into the smaller or more blocked nostril). To make insertion easier, moisten the device with water or saline solution.

After use, remove the Nasal Eq. by gently pulling on the “bridge” that connects the two ends. After use, it is recommended to clean it thoroughly with soap and water and dry it before storing it in its case until the next use.

Dosage

Your specialist will tell you how long to use the device. Normally, the Eptamed Nasal should be worn for at least three hours during the day and all night long.

Age Range

We recommend using Eptamed Nasal starting at age 5; there are no age restrictions on its use.

Contraindications

Avoid blowing your nose while wearing the Eq. Eptamed Nasal device.

Stop using the device if any parts are damaged or if the device appears to be broken.

Replacement Criteria

Always consult a specialist. However, it is recommended that the Eptamed Nasal device be replaced if structural changes occur that could compromise its function.

We recommend moving up to a larger size approximately every 3 months of use, until a functional and aesthetic balance is achieved in both nostrils.

In any case, the Eptamed Nasal device must be replaced no later than 12 months after first use.

Storage

Store the Nasal Eq. in a dry, clean place away from heat sources or direct sunlight; do not allow it to come into contact with essential oils or citrus fruits, which could stain it.

Always ensure that the hygiene conditions under which Eq. Eptamed Nasal is stored are appropriate for its intended use; always handle it with clean hands and store it properly.

Materials Used

Eq. Eptamed Nasal is sold in a biocompatible polypropylene-based plastic material known as a thermoplastic.

Expiration Date

If stored in its original packaging and in an environment suitable for storage, the device can be used within 5 years.

Manufacturer Information and Symbols

Eptamed Srl
Via Ravennate, 979
47522 Cesena (FC) ITALY
Tel. +39 0547 483800
Toll-free number 800-587733
www.eptamed.com

Publication Date: July 2019 — Last Revised: November 2024

Explanation of Symbols

Simbolo fabbricante 2

Manufacturer’s Instructions

Simbolo data fabbricazione 2

Indication of the date of manufacture

Simbolo lotto 2

Manufacturing lot number (in place of the word “Lot”)

Simbolo ref 2

Catalog Number

Simbolo istruzioni 2

Read the instructions before use

Simbolo ce 2

CE Mark

Simbolo dispositivo medico 2

Medical device

Download the original package insert

Italian version of the official Eptamed package insert.

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