Description
GENERAL INFORMATION
• Intended Use: The Hans Rudolph 6600 V2 Mask™ series are disposable, single-patient
use, adult Oro-Nasal CPAP/BiLevel mask which incorporates passive, continuous flow
exhaust ports built into the mask. It is intended for use with CPAP/BiLevel machines for
treatment of obstructive sleep apnea, and for use with other similar ventilators that use this
exhaust port configuration providing a minimum of 3 cmH2O pressure measured at the
mask.
• Indications for Use: The V2 Mask™ are for use on adult patients (greater than 30 kilo-
grams weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring
CPAP/BiLevel or non-invasive ventilatory support at pressures greater than or equal to 3.0
cmH2O at the mask in hospitals and other clinical settings.
- mask which incorporates passive, continuous flow exhaust ports built into the mask. It is intended for use with CPAP/BiLevel machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that use this exhaust port configuration providing a minimum of 3 cmH2O pressure measured at the mask.
- Indications for Use: The V2 Mask™ are for use on adult patients (greater than 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP/BiLevel or non-invasive ventilatory support at pressures greater than or equal to 3.0 cmH2O at the mask in hospitals and other clinical settings.
- Environment of Use: The V2 Masks™ are for use in hospitals and other clinical settings by individuals that have at least minimal instructions or training on the use of the mask as well as the device to which the mask are intended to connect.
- Cautions:
- Federal law restricts this device to sale by or on the order of a physician.
- At low CPAP/BiLevel pressures the flow through the mask vent holes may be inadequate to clear all exhaled gas from the tubing. Some rebreathing may occur. ) Patients with facial hair, especially beards, may experience mask leakage which may require shaving the hair.
- Warnings: Refer to: Instructions for Use, Document No. 691273, shipped with product.
- Contraindications & Complications: Refer to: Instructions for Use, Document No.
