Disposable Antimicrobial Medical Respirator (99,99% efficiency against pathogens)

Description

Recommended for healthcare professionals who work in areas with medium to high probability of viral presence in the ambient air.

Viruses are transmitted through droplets, emitted when a person speaks, coughs, sneezes; or are spread through viral aerosols at high concentrations in ambient air.

The Disposable Virucidal-Bactericidal Medical Respirator is a medical device manufactured by BioSerenity that combines the filtration efficiency of masks with the air decontamination technology of CIDALTEX®, which integrates antibacterial and antiviral properties.

The mask retains the filtration quality of N95 respiratory masks, which not only lowers the risk of transmission (if the wearer is infected), but also substantially reduces the risk of contamination by environmental factors. The user is effectively protected against infectious agents transmitted by “aerosols“ or “droplets” (via inhalation/exhalation).

The addition of CIDALTEX® technology to one of the mask’s filter layers permits the decontamination of air inhaled and exhaled by trapping infectious agents and destroying them via a decontaminant agent. This layer significantly enhances the user’s level of protection by eliminating bacteria and viruses filtered within the mask.

CIDALTEX® Technology provides anti-bacterial and anti-viral protection

Technology developed by BioSerenity in collaboration with the University of Lille and INSERM. The layer functionalization grafting process is based on the scientific work from the University of Lille.

(Existing Patent FR2984176A1 / 2013)

Masks
A: 127 ± 5 mm
B: 160 ± 5 mm
C: 107 ± 5 mm

Elastic Straps
Length: 180 ± 10 mm
Thickness: 3 ± 1 mm

Nose Clip
Length: 100 ± 10 mm
Width: 5 ± 1 mm
Thickness: 0.6 ± 0.1 mm

Weight
< 10 g

Packaging
Case: 50 masks
Box Size: 135 x 135 x 125mm

The box is covered in a plastic film in order to protect the masks until they are used.

Medical Device conformed to European Directive 93/42/EEC

• Certified to EN 14683 Standard
• Superior filtration and breathability
  (EN 149)

Made in France

• Production factory in Troyes
• Raw European materials

Advanced filtration reduces risk of transmission via droplets and aerosols.

• Bacterial Filtration Efficiency* > 98%
• Differential pressure < 60 Pa / cm2
• Splash resistance pressure ≥ 16kPa
• Penetration of liquid and solid aerosols** < 6%
• Average inward leakage < 8%

Air Decontamination Technology

• Integrated within the filtration layer of the mask CIDALTEX® eliminates viruses and bacteria.
• Antibacterial efficiency > 99.99% (4log) contact inactivation, measured in 2 hours on E. coli and S. aureus*
• Antiviral efficiency > 99.99% (4log) air flow decontamination, measured in 5 minutes on Coronavirus 229E (HCOV 229E)

Breathable comfortable mask

• Soft interior surface upon the skin
• Efficient air permeability allows for natural breathing (breathability according to standard EN149)
• Recommended wear time: 4h

*Reference particle size: 3μm ; **Reference particle size: 0.6 μm

• Ear Loops : polyamide and elastane, latex, and rubber free
• Nose Clip : flexible composite (presence of polyethylene, steel)

Exterior Layer:
Purpose: Anti-droplet protection and mask barrier
Substance: Polypropylene
Non-Woven Fiber: Spunbond
Density: 25 ± 5 g/m2
Color: Blue

Air Decontamination Filter Layer:
Purpose: Advanced filtration eliminates infectious particles
Substance: Polypropylene
Non-Woven Fiber: Meltblown and Spunbond
Density: 50 ± 10 g/m2
Color: White

Filter Layer:
Purpose: Advanced filtration
Substance: Polypropylene
Non-Woven Fiber: Meltblown
Density: 25 ± 5 g/m2
Color: White

Interior Layer:
Purpose: Protection, mask wear and comfort
Substance: Polypropylene
Non-Woven Fiber: Spunbond
Density: 25 ± 5 g/m2
Color: White

Inward Leakage (EN 149 chap.7.9.1.)
< 11%

Average Inward Leakage
< 8%

Penetration of Filter Material (EN 149 chap.7.9.2)
Solid (NaCl): < 6%
Liquid (paraffin oil): < 6%

Breathing Resistance – Inhalation (EN 149 chap.7.16)
30 L/ min: 0.7 mBar
95 L/min: 2.4 mBar

Breathing Resistance – Exhalation
160 L/min : 3.0 mBar

Advised Wear Time
4 hours

Security

• Medical device containing an air decontaminating inner layer with anti-viral and anti-bacterial actions verified in accredited laboratories.
• Laboratory-tested fixation of the decontaminant agent (ADBAC) to avoid skin contact or inhalation under the recommended conditions.
• In the event of an allergic reaction, remove the mask immediately.
• Do not touch the front of the mask with your hands while wearing it.
• Change the mask as soon as it becomes wet, at least every 4 hours.

Storage

• Store away from direct sunlight, dust, and humidity.
• Masks can be stored for 3 years. Discard and replace the mask if it:
  • is damaged
  • interferes with breathing
  • becomes wet
  • is contaminated with one or more fluids, bodily or any other infectious elements.