Technical sheet mc-001

MC-001- DISPOSABLE SURGICAL MASK WITH FILTER

Product Name: : Surgical Mask

Model: MC-001

Type of device: Classe I – Non sterile

Category:SURGICAL MASK, Medical Device

Color: white

Material: 3 layers of non-woven fabric (TNT) SMS FF70/310 PBT PB SMS 70gr/m2 (100% polypropylene, glass fibre free), elastic (70% polyester, 30% elastane – Latex free).

 

 

Characteristics:

Excellent fit

  • Excellent breathing capacity
  • Free of fiberglass
  • Nickel-free
  • Conformable
  • High filtration, BFE filter power > 95% according to UNI EN 14683:2019
  • Good longitudinal and transverse tensile strength
  • Water repellent
  • Very low permeability only to the water column
  • Ultralight
  • Hypoallergenic
  • Very low flammability (burning in contact with flame and tends to go out)
  • Low electrostatic

Dimensions:: 165×95 mm. Weight: 2,5 g.

 

Certification:: Meets the requirements of UNI EN 14683, TYPE II. And meets the essential requirements of Directive 93/42/EEC.

 

Conservation information: keep dry and ventilated away from sunlight, fire and other pollutants
Quantity:: 20pcs. /cf or 50 pcs. /cf
Precaution of use:do not use in case of obvious defects such as damaged, perforated or cut TNT.

 

Contraindications and repetitions: : there are no particular contraindications in the use of this device.

 

Mode of disposal: : disposal according to the current rules.

 

Pictograms::

Instructions for use

HOW TO USE THE DEVICE:

 

 

 

 

Before use, check the condition of the device, DO NOT use the mask if there is damage (breaks, cuts, lack of fixation devices, etc.) or if there is dirt on the breathing side.
1.Before using the mask, wash your hands with soap and water or an alcoholic solution.

2.Wear the elastic mask behind your ears

3.Cover your mouth and nose with the mask, making sure it sticks well to your face.

 

 

*4 to verify that the device has been used correctly, cover the mask with your hands and breathe. If air flows through the nostrils, replace the mask. If leaks are seen along the edges of the mask, reposition the device on the face. Repeat the operation until an optimal result is obtained.

If you are unable to wear the mask correctly, avoid the contaminated area.

 

 

 

PRECAUTIONS FOR USE:

If the instructions for use and restrictions on the use of the mask and/or the use of the mask are not applied rigorously throughout the entire exposure period, the effectiveness of the mask will be reduced and may result in contamination or death.

Prior to use, the user shall be informed of the correct use of the mask in accordance with the applicable health and safety statements.
The mask shall not be used in sterile and aseptic environments, such as operating rooms, outpatient, or in any environment in which sterility must be guaranteed as a TYPE II NON STERILE DEVICE according to EN 14683: 2019.
The mask should not be used if the percentage of oxygen in the atmosphere is less than 17%, the mask can only be used in well-ventilated areas containing sufficient oxygen. If the mask is damaged or hard to breathe, immediately leave the contaminated area, remove and replace the mask.

Leave the contaminated area immediately if you experience dizziness or other discomfort.
Do not alter or modify the mask. Do not use the bearded mask or other facial hairs that prevent direct contact of the face with the edge of the device.

The mask should only be used when concentrations of harmful substances are known. In the case of unknown substances or of variable conditions, a breathing device shall be used.

USEFUL LIFE

Excessive resistance to breathing indicates the obstruction of the mask to dust particles, the mask is an individual device, the maximum duration of use is for a shift work or 8 hours a day.

STORAGE AND PRESERVATION INSTRUCTIONS::

Until use, the mask must be kept in its original packaging, sealed to preserve its properties.
During preservation, transport and storage, the environmental conditions laid down by the manufacturer for the correct preservation of the product must be complied with.

DEADLINE::

the product guarantees its performance for a period of 60 months from the date of manufacture shown on the packaging.

 

 

PHOTO OF THE PRODUCT:

characteristics: Fabric (Certified by the laboratory of the University of Turin)
FF 70/310 PBT PB SMS PF209234 verified according to BS EN ISO 10993-12:2012 and BS EN ISO10993-5:2009.

FF 70/310 PBT PB SMS

Facemask filter media Medical facemask for Surgical Type I, Type II and Type IIR by EN 14683, can be used as single fleece.
Product characteristics:

Synthetic Polyester Filter media

Three-layer SMS: Spunbond (PET) 20 gsm + Meltblown (PBT) 30 gsm + Spunbond (PET) 20 gsm, point bonded (thermo)

Product characteristics:

o Synthetic Polyester Filter media

o Three-layer SMS: Spunbond (PET) 20 gsm + Meltblown (PBT) 30 gsm + Spunbond (PET) 20 gsm, point bonded (thermo)

o Water-repellent

o Binder-free, latex-free, glue-free, glassfiber-free

o Color: white

o Can be used with flow from both sides with same characteristic

o Sterilization after mask assembling is recommended for medical application