ViVi® Surgical Protection Hood

The single-use ViVi® hood is composed of a front blue layer of polypropylene, a rear polypropylene SB filter, and a clear visor located in the face area. Its design allows the surgical field to be viewed in a protected manner, preventing high-speed particles from impacting the face and splashing fluids or infectious contaminants that could compromise the health of the healthcare professional. It is extremely light, easy to use and has multiple certifications in terms of efficacy and quality, making it perfectly suitable and reliable for the professional environment.

Performance data
- Personal protective equipment certified by EN 166:2001 standard (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 area) and EN 13795 (CE) (level "high performance - critical area")

Features
- Viral penetration resistance: suitable AQL 4.0 (HM) (according to ASTM F1671 standard)
- Microbial penetration resistance - wet: IB 6.0 (HM) (according to EN 22610 standard)
- Microbial penetration resistance - dry: ≤ 300 CFU (HM) (according to EN 22612 standard)
- Liquid penetration resistance: ≥ 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), 25-30% (FM) (according to ASTM F2101-07 standard)
*HM corresponds to the hood material (blue) and FM, to the filter material (white)

Technical specifications
- Color: blue hood and white filter
- Weight: 92 g
- Sterilization method: ethylene oxide
- Dimensions (height x width): 900 x 780 m
- Size: one size
- Facial protector dimensions (height x width): 200 x 340 mm
- Field of view: > 180°
- Enclosing field: made of Spunbond PP, weighing 40 g/m2
- Storage conditions: temperature < 30 °C
- Shelf life: 3 years

Hood technical specifications
- Blue color, with breathable viral barrier
- Composition: trilaminated polypropylene and breathable film
- Base weight: 69 g/m2 (according to ASTM D3776 standard)
- Mullen burst resistance in dry: 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

Filter technical specifications
- White color, with breathable air ventilation
- Composition: double layer of SB polypropylene, 100% non-woven fabric
- Base weight: 30 g/m2, 15 g/m2 (according to ASTM D3776 standard)
- Tensile strength 30/15 g (MD/CD): 81/31 N/5cm (MD), 41/25 N/5cm (CD) (according to EN29073-3 standard)
- Break resistance 30/15 g (MD/CD): 90/58 % (MD), 78/63 % (CD) (according to EN29073-3 standard)
- Flammability: Class I (according to 16 CFR 1610.4 standard)
*MD corresponds to the machine direction and CD, to the cross direction

Facial protector technical specifications
- Clear visor
- Composition: clear 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)

Regulations and certifications
- CE mark
- 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)