CIDALTEX® FFP-Endo Mask – 10 Packets of 5 masks

CIDALTEX® FFP-Endo Mask – 10 Packets of 5 masks

CIDALTEX® FFP-Endo Mask – 10 Packets of 5 masks

94,70 Excluding VAT (VAT 5.5% extra)

In stock

94,70 Excluding VAT (VAT 5.5% extra)

  • 1,99 € T.T.C. per unit
  • Minimum Order: 50 disposable masks (10 packets of 5 masks)
  • Certified Medical Device according to EN-14683
  • Contains Unique diaphragm holes for smooth insertion of the fiberscope (endoscope) and adhesive caps for a complete mask seal
  • Antiviral and antibacterial activity demonstrated by in vitro laboratory test
    • Antiviral efficiency > 99.96%
      limit of detection, measured in 20 minutes on Human Coronavirus (HCoV-229E)
    • Antibacterial efficacy > 99.99%
      contact inactivation, measured in 2 hours on E. coli and S. aureus
  • Bacterial Filtration Efficiency
    (BFE) > 99.8%
  • Particulate Filtration Efficiency
    (PFE) > 97%
  • PFE performance according to EN-149 (FFP2 grade)
  • Synthetic Blood Splash Resistant
  • Made in France
  • Delivery: 5 days (on average)
SKU: 1016-07014-FR Category:

Description

Recommended for patients undergoing transnasal endoscopic procedures.

These procedures are considered high risk due to infectious aerosol transmission spread by the fiberscopic tool. Practitioners are required to wear personal protective equipment (PPE) during endoscopies.

The CIDALTEX® FFP-Endo Mask effectively limits the spread of aerosols transmitted via bioparticles from within the patient’s nasal cavities. It retains an FFP2 face fit shape that mitigates airborne bioparticle leakage. Specifically adapted to the COVID-19 situation, the CIDALTEX® FFP-Endo Mask is a necessary element of protection for both the practitioner and their endoscopic patients.

The CIDALTEX® FFP-Endo Mask also retains the filtration quality of FFP2 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 FFP-Endo Mask was developed through the recommendations of Dr. Giovanni and team at Aix-Marseille University and Marseille Public University Hospital (APHM).

The addition of patented CIDALTEX® technology to the central mask filter layer permits the decontamination of air inhaled/exhaled. It traps infectious agents and destroys them via a decontaminant agent. CIDALTEX® significantly enhances the user’s level of protection by inactivating bacteria and viruses 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, FFP2 grade)

Made in France

  • Production factory in Troyes
  • Raw European materials

FFP2 grade 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%

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 > 99.96% (3.4log) limit of detection, measured in 20 minutes on Human 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: 1h

*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 FFP2 grade
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

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

Precautions for Use 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.
Not intended for pregnant women or children

Storage

  • Store away from direct sunlight, dust, and humidity.
  • Masks can be stored for 5 years. Discard and replace the mask if it:
    • is damaged
    • interferes with breathing
    • is moist
    • is contaminated with one or more fluids, bodily or any other infectious elements.

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