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VADI CPAP Nasal Mask and Accessory

Part Number
  • VB14-02
Features

VADI CPAP Nasal 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 31±3 dB within a radius of 1 meter to the mask, which is extremely quiet.

VADI CPAP Nasal 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:

VB14-02-S Small (153*159*81 mm)
VB14-02-M Medium (153*159*83 mm)
VB14-02-L Large (153*159*91 mm)

 

Material: Silicone, NYLON, PC and Spandex

Pressure Range: 5-40 cm H2O

Interface Connection: Cone Connector(ISO 5356-1)

Mask Dead Space: <120 ml

Sound Pressure: 31±3 dB within one meter

Breathing Resistance: 0.19 cm H2O @ 50 LPM/ 0.34 cm H2O@ 100 LPM


Certification

◎ Complied with the ISO 13485 Quality 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: 5-40cmH₂O

Breathing Resistance: 0.19 cmH₂O @ 50 LPM/ 0.34 cmH₂O @ 100 LPM

Noise: 31±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


Accessory


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VADI CPAP Mask and Accessory

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