MEDICAL FACE MASK BeOnTop Medical™.
Model: MASK2102 Type I according to CE EN 14683
 
OPERATING INSTRUCTIONS: Medical face mask, device covering mouth and nose in order to provide a barrier and minimize direct transmission of infectious agents. DESCRIPTION OF THE DEVICE The medical device covered by these operating instructions is a washable mask, made of polypropylene fabric (PP) – Elasthan (EA/Lycra) and Polyamide (PA), intended to be used to protect yourself during operations exposing you to risks. The mask is a mechanical barrier against materials and substances. In fact, the mask is used to prevent contamination and protect the respiratory tract from dust, spray and other material. The medical device is not sterile and it is reusable.
UNI EN 14683:2019 e UNI EN ISO 10993-1:2010
 
Details:
• Washable and reusable fabric at 60°
• Multifibre breathable fabric
• Soft ,easy and pleasant to wear
• Excellent breathability
• Anti-drip Fabric
• 100% made in Italy
 
CLEANING AND SANITATION
1.Clean the product with warm water (max 60 °C) and with neutral detergents and sanitising agents. The mask can be hand washed, for up to 20 washes, immersing it, gently scrubbing it and squeezing it into water and neutron soap and sanitizing agent
2. It can be tumble dried at a maximum temperature of 80 °C. OR in open air avoiding direct sunlight.
3.The device can be ironed but not in direct contact with hot
 
INTENDED USE
There is no use other than those described in the paragraph “INDICATION OF USE”. It is also absolutely forbidden:
• Use of the mask as a personal protective device.
• Use of the medical device by subjects who have not carefully read the operating instructions.
• Use by people allergic to the substances the product is made of.
• Use by children if not supervised by adults.
• Use of the device for applications inconsistent with those indicated in the “INDICATION OF use”.
• Apply the mask to injured skin or wound.
• Apply the medical device to body parts other than the face.
 
LIMITS OF THE DEVICE
Masks do not treat any disease.
RESIDUAL RISKS
and safe use of the device. If the structure of the device is modified because of an accidental impact, such as a rubbing against an abrasive material, such as to make it or possibly risk of making it dangerous and/or unusable, you must contact the authorised assistance and follow their instructions.
 
USE PRECAUTIONS:
1.If the operating instructions and restrictions relating to the use of the mask are not strictly complied with and/ or the mask is not used during the entire exposure period, the effectiveness of the mask will be not be guaranteed and may lead to contamination.
2. Before use, the user must inquire about the correct use of the mask in accordance with the applicable safety and health indications.
3. The mask must not be used in sterile and aseptic environments, such as operating rooms, clinics, and any environment where sterility must be guaranteed, as it is A NON-STERILE type I DEVICE according to standard EN 14683: 2019.
4. Do not alter or modify the mask.
 
SIDE EFFECTS
There are no side effects to report in the operating instructions. However, do not apply the product in case of skin injury or irritation. If the product causes irritation, discontinue the application immediately and seek medical advice.
 
CONTRAINDICATIONS
The medical device can cause irritation on subjects who are particularly sensitive or allergic to the materials with it is made of. Do not use if you are allergic to polypropylene or polyamide compounds.
 
RETENTION
1. Before storing the device, check that it is clean.
2. Store the device indoors cool, away from atmospheric agents and steam jets. 3. Store away from heat, open flames and direct sunlight.
4.After use, store the washed and completely dried mask in a container, protected from direct sunlight, atmospheric agents, heat, dust, liquids and moisture.
 
DISPOSAL
Once the device had been used, proceed with its disposal. The construction materials of the device do not require special disposal procedures. Reference should be made to local standards for the treatment of waste in a landfill. Before disposing of the device, store it in a bag- Do not dispose of or leave the product in the environment for any reason.
 
EXPIRE:
The device guarantees its performance for a duration of 36 months from the date of manufacture shown in the package.