ViVi® HFD Surgical Protection Hood with High Microbial Filtration

The ViVi® HDF hood is a highly microbial filtration protective equipment that offers healthcare professionals the ability to visualize the surgical field in a protected manner, avoiding risks of contamination or mechanical injury. Its composition integrates lightweight and breathable materials such as polypropylene and polycarbonate to offer a comfortable and practical prophylaxis experience and includes waistbands to perfectly adjust to the user's body. On the front, it has a transparent screen that not only prevents the penetration of a wide spectrum of pathogens, but also protects against high-speed particles that may be ejected during surgery. Its features and the multiple standards that have been followed during its manufacture certify it as a safe and reliable tool for surgical environments.

Performance Data
- Personal protective equipment certified by EN 166:2001 (individual eye protection). Effective against high-speed particles (45 m/s) with low-energy impact and liquid splashes.
- Not indicated as a respiratory protection device
- Adheres to surgical gown performance standards such as ASTM 2407-06 (FDA) (incl. AAMI PB70 - Level 4 - critical zone) and EN 13795 (CE) (level “high performance - critical zone”)

Characteristics
- Resistance to viral penetration: suitable AQL 4.0 (HM) (according to ASTM F1671 standard)
- Resistance to microbial penetration - wet: IB 6.0 (HM) (according to EN 22610 standard)
- Resistance to microbial penetration - dry: ≤ 300 CFU (HM) (according to EN 22612 standard)
- Resistance to liquid penetration: ≥ 100cm H2O (HM) (according to EN 20811 standard)
- Biocompatibility (skin irritation): approval criteria for surface/broken or compromised skin device, limited exposure according to ISO 10993
- Biocompatibility (EO residues): ≤ 10μg/cm2 (according to ISO 10993-7 standard)
- Sterility: SAL 10-6 (according to EN 556-1) obtained through a sterilization process validated according to ISO 11135-1 standard
- Flammability: Class I (according to 16 CFR part 1610 standard)
- Particle emission rate: ≤ 4.0 log10 (according to ISO 9073-10 standard)
- Cleaning (particulate material): IPM ≤ 3.5 (according to ISO 9073-10 standard)
- Bacterial filtration efficiency: < 99.999% (HM), < 99.939% (FM) (according to ASTM F2101-07 and MIL-M-36954 standards)
*HM corresponds to the hood material (blue) and FM, to the filter material (white)

Technical Specifications
- Color: blue hood and white filter
- Weight: 90 g without packaging, 140 g with packaging
- Sterilization method: ethylene oxide
- Dimensions (height x width): 900 x 700 m
- Size: one size
- Dimensions of the face shield (height x width): 200 x 340 mm
- Field of vision: > 180º
- Surrounding field: made of Spunbond PP, with a weight of 40 g/m2
- Storage conditions: temperature ≤ 30 ºC
- Shelf life: 3 years

Technical Specifications Hood
- Blue color, with breathable viral barrier
- Composition: trilaminated polypropylene and breathable film
- Base weight: 68 g/m2 (according to ASTM D3776 standard)
- Dry Mullen burst resistance: 2750 g/cm2 (according to ASTM D 4533-91 standard)
- Dry tensile strength (MD/CD): 2440/1190 N/m (according to EN29073-3 standard)
- Moisture vapor transmission rate at 32 °C, 50% relative humidity: 1300 g/m2/day (according to ASTM E-96 B standard)
- Flammability: Class I (according to 16 CFR 1610.4 standard)
*MD corresponds to the machine direction and CD, to the cross direction

Technical Specifications Filter
- White color, with breathable air ventilation
- EFB: < 99.85% (according to ASTM F2101, adapted with higher challenge level)
- EFB (0.3 – 0.4 μm): 72 % (according to ASHRAE 52.2 MERV, Initial (0.51 m/s))
- EFP (0.4 – 0.55 μm): 79.4 % (according to ASHRAE 52.2 MERV, Initial (0.51 m/s))
- EFP (0.55 – 0.7 μm): 86.7 % (according to ASHRAE 52.2 MERV, Initial (0.51 m/s))
- EFP (0.7 – 1.0 μm): 91.3 % (according to ASHRAE 52.2 MERV, Initial (0.51 m/s))
- EFP (1.0 – 1.3 μm): 94.4 % (according to ASHRAE 52.2 MERV, Initial (0.51 m/s))
- EFP (1.6 – 2.2 μm): 97.7 % (according to ASHRAE 52.2 MERV, Initial (0.51 m/s))
- EFP (2.2 – 3.0 μm): 98.7 % (according to ASHRAE 52.2 MERV, Initial (0.51 m/s))
- EFP (3.0 – 4.0 μm): 99.2 % (according to ASHRAE 52.2 MERV, Initial (0.51 m/s))
- EFP (4.0 – 5.5 μm): 99.6 % (according to ASHRAE 52.2 MERV, Initial (0.51 m/s))
- EFP (5.5 – 7.0 μm): 99.8 % (according to ASHRAE 52.2 MERV, Initial (0.51 m/s))
- EFP (7.0 – 10.0 μm): 100 % (according to ASHRAE 52.2 MERV, Initial (0.51 m/s))
- Pressure drop: 0.46 mm H2O (according to TSI8130 standard)
- EFV: ≥ 99.40% (according to ASTN F2101 standard)
*EFB corresponds to bacterial filtration efficiency; EFP, to particle filtration efficiency and EFV, to viral filtration efficiency

Technical Specifications Face Shield
- Transparent visor
- Composition: transparent polycarbonate film
- Thickness: 375 μm
- Density: 1.2 g/cm3 (according to ISO 1183 standard)
- Haze: < 0.5 % (according to ASTM D1003 standard)
- Light transmission: 89% (according to ASTM D1003 standard)
- Tensile strength: 60 MPa (according to ISO 527 standard)
- Flexural strength: 91 MPa (according to ISO 187 standard)
- Dielectric constant: 3
- Surface resistivity: 1.00+16 Ω/sq. (according to IEC 60093 standard)
- Volume resistivity: 1.00+17 Ω-cm (according to IEC 60093 standard)
- Flammability: V-2/ VTM-2 (according to E249605 standard)
- Optical quality: Class I (according to EN 166 cl. 7.1.2.1 standard)

Standards and Certifications
- CE marked
- Class I sterile Medical Device, in accordance with Directive 93/42/EEC
- PPE product in accordance with (EU) 2016/425

Compatibility
- ViVi® surgical helmet (Ref. 9428880100)
- ViVi® surgical helmet with LED light (Ref. 9428880130)