Instructions for use medical face mask TFM14

INSTRUCTIONS – medical face mask version 18.5.2021

Manufacturer: Teho Filter Oy, Jussintie 5–7, 85410 Sievi, Finland, www.tehofilter.fi

Product name: TFM14
The product is tested according to the standard EN 14683:2019 + AC:2019 type IIR and standards EN ISO 10993-5 ja EN ISO 10993-10.

Intended use

The product is a medical face mask. The product is single use. The product protects the wearer from splashes and protects the surroundings from wearers respiratory emissions. According to the risk analysis of the workplace, use also for example face shield or eye shield and other protective gear such as protective gloves or protective clothing if necessary. Ensure the mask is suited for the task you perform.

This product is not a respiratory mask. If the task requires actual respiratory mask, for use must be chosen for an example filtering half mask according to standard EN 149 with sufficient level of protection.

Warnings and limitations of use

Face mask has not been tested to be used in explosive atmospheres. The flammability of the face mask has not been tested. It is not to be used in the proximity of open flame. Face mask or its materials are not known to cause irritation or harm to its user.

If the product causes any symptoms on respiratory tract or skin, contact healthcare professionel. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. The product is not recommended for small children. Reuse is an infection risk.

Instructions for use

The user of the mask must be instructed to its use, ensuring fit, taking off and disposing of the mask before the first use. The proper use of the mask in all phases of use is important. If instructions are not followed, the user of mask can be exposed to a health risk during use of the mask.

Inspection before use

Wash or disinfect hands before touching the mask. Inspect the package of the mask is undamaged and the mask is intact. Inspect the last date of storage and do not use mask if it’s expired.

Wearing and trying on the mask and ensuring fit

Kirurginen suu-nenäsuojain käyttöohje | Bruksanvisning Kirurgiskt munskydd | Instructions for use medical face mask

Set the mask on face colored side facing outward, the metal thread against nose. Pull the mask pleats open under your chin. If you use other protective equipment with face mask, ensure that products used simultaneously do not cause disadvantage to each other’s safe usage.

Usage and taking off and disposing of mask

Use mask continuously. Do not touch outer surface of mask during use. Do not remove mask temporarily during use. Use the face mask in such a manner that it covers nose and mouth. Never lower the mask for example hanging from your neck. Change to a new mask if you have to remove it from face or the mask is damaged. Use mask continuously on maximum 4 hours.

Before removing the mask, wash or disinfect hands. Remove the face mask without touching the outer surface of the mask. Lift it off from face for example by grabbing it from the earloops. Place used face mask either in a plastic bag and close the bag or in a trash bin intended for this use. In the end wash or disinfect hands.

Do not use mask if the last date of storage has passed.

Maintenance, cleanup and disinfection

The face mask is intended for single use.

Storaging

Store the masks in a dry space which temperature is between -5…+40 °C, the relative humidity under 65%.

See the packaging markings

Packagin markings | Instructions for use medical face mask                     

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