Protection Face Mask NTF with Filter – Ústenka NTF s filtrem
CERTIFICATE – DECLARATION of CONFORMITY – Manufacturer PRONELATEX s.r.o.
Notified medical device by State Institute of Drug Control (SÚKL) :
Register of Medical Devices Nr.: 926153
Clinically approved medical device – by LDN Hradec Králové (Medical center for long-term patients at Hradec Králové)
GMDN generic device group : 37713 Surgical/medical face mask
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a reusable device.
FACE PROTECTION MASK NTF WITH FILTER
Protection against non-toxic and low to medium toxic solid and liquid aerosols. Replace the mask with a new one after 4 hours of wearing . The washing temperature is up to 95’C, at lower temperatures disinfectants can be used for washing. Respiratory mask material polypropylene , polyester and polyamide , tolerates dry cleaning. Do not bleach. When washing, we recommend using a washing bag to avoid tangling the laces. Up to 50 wash cycles can be achieved with gentle washing. Attention , we only iron up to 11O ‚C! Let the respirator dry freely, or use a tumble dryer for the gentlest program.
WARNINGS AND RESTRICTIONS:
Always make sure that the product is:
• Suitable for the application
• Fitted correctly
• Worn throughout the exposure
• Replaced when needed
For optimal protection of the user against certain contaminants contained in the air, it is essential to chaose the right protective equipment , proper user training and adherence to follow the instructions for use and store the product properly. Failure to follow these instructions or improper handling of the respiratory protective equipment while the user is in a contaminated environment can have adverse health effects and lead to serious illness, permanent disability, or death.
1. Before using this product , consult a hygienist or safety technician to see if it meets your needs.
2. This product does not supply oxygen . Use only in adequately ventilated areas containing
sufficient oxygen to sustain life. Do not use this product if the oxygen concentration is below 19%.
3. Do not use if the concentration of pollutants directly endangers health or life.
4. Do not use in an explosive atmosphere .
5. lmmediately leave the work area and seek fresh air if (a) breathing becomes difficult, or (b) dizziness or other nausea occurs.
6. The protective effect of the product may be reduced by the beard or hair on the face or
certain prominent facial features .
7. Under no circumstances should you change or modify the product.
Before putting on the product , you should wash your hands thoroughly to avoid contaminating the inside of the face mask.
The face mask must be placed over the mouth, nose and cheeks so that it is tight everywhere. Tighten and tie the fixation straps properly. We recommend trying the „cross“ binding, when you combine the binding of the upper and lower fixing laces.
Before taking action , you should test for a while whether you are wearing a face mask properly and that you can breathe „normally“ .
The hydrated respirator must be removed immediately or replaced .
Pathogens may stick to the outside of the face mask used.
After removing the face mask , you should wash your hands with soap for at least 20-30 seconds .
WASHING AND IRONING
If you use a reusable mouth-nose protection, it should be put in the washing machine immediately after use, as soon as you have removed it. We wash the face mask separately from other washes in a wash bag.
For washing, we use a normal cleaning agent with a disinfectant effect. Do not use chlorine bleach. The wash should be carried out at least 60 ° C (min. 30 min.), 95 ° C is better.
Hand wash – water bath – UP TO 50 WASHING CYCLES !!!!
We soak the face mask in water and let it boil on the stove in a water bath (5 minutes), then cool in the water and then let the face mask dry.
The mouthguard can be ironed.
Attention, the temperature of the curling must not exceed 110 ° C. Curl the fabric of the mask from both sides.
How to use the Ústenka NTF s filtrem correctly?
How to interpret the results of tests of notified laboratories (notified and approved EU laboratories)? What makes the NTF face mask with filter, better than other respirators and medical drapes, in the fight against coronavirus?
According to EN149: 2001 + A1 2009 for FFP respirators, the functionality of respirators is tested by a paraffin test.
A key parameter for using the NTF face mask is the proven ability to capture and absorb 120 mg of paraffin aerosol.
The result of test according to EN149: 2001 + A1 2009: 100% efficiency of capturing 120 mg of paraffin, at a flow rate of 95 liters of air with a paraffin aerosol in one minute.
A person with a medium load, exhales 0.3 -0.5 liters of water in one day. Which is 12.5 – 20.8 mg of water per hour.
Exhale 120 mg of water moisture in a breath in 5.7 to 9.6 hours.
What does this mean when using an NTF face mask? If I replace the NTF face mask before it is hydrated, I have 100% protection against coronavirus, which spreads in the form of aerosol droplets.
We recommend replacing the NTF face mask with filter after 4 hours of continuous wear at the latest.