Part Number

• VB14-01-S / M / L

Features

VADI CPAP Full Face Mask is made of medical-grade liquid silicone rubber. It has excellent comfort, skin-friendly durability and will not cause allergic reactions. Connecting it to the CPAP machine only generates noise measured as 32±3 dB within a radius of 1 meter to the mask, which is extremely quiet.

VADI CPAP Full Face Mask is suitable for connecting Bilevel Positive Airway Pressure (BiPAP) as well as Continuous Positive Airway Pressure (CPAP) and Automatic Positive Airway Pressure (APAP) and introducing breathing gas to non-invasive accessories of patients. It is to provide adults who need to use a Non-Invasive Ventilation (NIV) for a long-term at medical institution or home.

Specifications

Size:

VB14-01-S	Small (186*109*108 mm)
VB14-01-M	Medium (196*109*108 mm)
VB14-01-L	Large (206*109*108 mm)

Interface Connection: Cone Connector (ISO 5356-1)

Pressure Range: 5-40 cmH2O

Mask Dead Space: < 255 ml

Sound Pressure: 32±3 dB within one meter

Material: Silicone, NYLON, PC and Spandex

Resistance: When Anti Asphyxia Valve (AAV) is open, resistance is at 0.9 cmH2O
When Anti Asphyxia Valve (AAV) is closed, exhalation resistance is at 1.2 cmH2O

Breathing Resistance: 0.3 cmH2O @50 LPM/ 0.47 cmH2O @100 LPM

Package: 6 pcs/ box

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Certification

◎ Certified by the ISO 10993 Biocompatibility Testing for Medical Devices, including:

* Passed ISO 10993-5 In Vitro Cytotoxicity Tests: L929 cell test

* Passed ISO 10993-10 Tests for Irritation and Skin Sensitivity:

Skin Irritation Test: No observation of irritation symptom after 15-day test of applying the extraction on the backside of rabbits.

Skin Sensitization Test: No observation of delayed hypersensitivity after 10-day test of applying the extraction on the backside of guinea pigs

◎ Passed Piper Medical ISO 17510-2 Sleep Apnoea Breathing Therapy

* Pressure Flow Characteristics: 5-40 cmH₂O

* Anti-Asphyxia Vale: open to the atmosphere 0.9 cmH₂O 

closed to the atmosphere 1.2 cmH₂O

* Breathing Resistance: 0.3 cmH₂O @ 50 LPM/ 0.47 cmH₂O @ 100 LPM

* Noise: 32±3 dB measured with a radius of 1 m to the mask

◎ Passed SGS ISO 18562 Biocompatibility Evaluation of Breathing Gas Pathway Device

* The Particulate Matter Emission Test

* The Volatile Organic Compounds Test

*  Profile of Leachables in Condensation

*  Toxicological Evaluation of Leachables in Condensation

◎ Passed SGS ISO 17664 Processing of Health Care Product

* Cleaning Validation for Reusable Medical Device:

Extraction of TOC 86.15%, Efficiency 99.94%

Extraction of Protein Residual 94.94%, Efficiency 99.95%

* Disinfection Validation for Reusable Medical Device:

Disinfection Efficiency＞99.9% and reaches 6Log reduction

◎ Adopt Medical-Grade Liquid Silicone Rubber

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Accessory

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Usage

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VADI CPAP Nasal Mask and Accessory (Click Here)

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Download

VADI CPAP Mask and Accessory (Click Here)