Hans Rudolph 7600 V2 Series Headgear Only AX1304

GENERAL INFORMATION
• Intended Use: The Hans Rudolph 7600 V2 Mask series are reusable, multi-patient use,
adult Oro-Nasal CPAPBiLevel mask which incorporates passive, continuous flow exhaust
ports built into the mask. It is intended for use with certain CPAP/BiLevel machines for
treatment of obstructive sleep apnea, and for use with other similar ventilators that use this
exhaust port confi guration 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 homes, hospitals and other clinical settings.
• Environment of Use: The V2 Masks™ are for use in homes, 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:
a.) Federal law restricts this device to sale by or on the order of a physician.
b.) At low CPAP/BiLevel pressures the fl ow through the mask vent holes may be
inadequate to clear all exhaled gas from the tubing. Some rebreathing may occur.
c.) Patients with facial hair, especially beards, may experience mask leakage which
may require shaving the hair.
• Warnings: Refer t Instructions for Use, Document No. 691270, shipped with product.
• Contraindications & Complications: Refer t Instructions for Use, Document No.
691270, shipped with product