Devilbiss V2 Full Face CPAP Mask

Features

• Devilbiss V2 Full Face CPAP Mask includes:
  - Mask
  - Headgear
• One piece design and soft material allows for greater flexibility
• 360-degree mask swivel for expanded patient freedom
• Headgear uses new quick-release strap clips and a foam material for improved comfort
• Anatomically contoured design with ribbed support to improve seal and comfort
• Integrated facial-sealing flange for improved fit
• Anti-Asphyxia valve that opens at mask pressure of less than 3cm H2O
• Swivel port micro-vent holes that dissipate CO2
• Two structural braces are added to aid in cushion stability
• Easily adjustable 4-strap headgear made of durable and comfortable polyurethane foam
• Reusable mask is steam autoclaveable and dishwasher safe, can also be cleaned via cold chemical and pasteurization processes
• Latex-free
• Multi-patient, multi-use products
• Single-molded mask frame and cushion with integrated chin support
• Also available (sold separately):
  -Devilbiss V2 Full Face Mask Face Piece With Swivel (Code: 113574)
  -Devilbiss V2 Full Face Mask Headgear (Code:201492)
  -Devilbiss V2 Full Face Mask Pace Piece (Code: 669180)

More Information

• Instructions for Use and Maintenance:
  - 1. Intended Use: The 7600 V2 Mask is a reusable, multi-patient, multi-use, Oro-Nasal CPAP/ BiLevel mask which incorporates a passive, continuous flow exhaust port. 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 configuration providing a minimum of 3 cm H20 pressure measured at the mask.
  - 2. Environment of Use:This mask is for use in homes, hospitals, and other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device to which the masks are intended to connect.
• Indications for Use:
  - This mask is indicated for use on adult patients (greater than 30 kg 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 cm H20 at the mask in homes, hospitals, and other clinical settings.
• 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 may experience mask leakage even though all fitting instructions are followed. If mask leakage is excessive, facial hair may need to be shaved to assure mask effectiveness.
• Warnings:
  - This CPAP/BiLevel mask should be used only with CPAP/BiLevel systems recommended by your physician or repiratory therapist. This mask should not be used unless the CPAP/ BiLevel system is turned on and operating properly. The vent holes in the mask should never be blocked.
  - These masks are intended to be used only with CPAP/ BiLevel systems which require vent holes in the mask to allow continuous air flow out of the mask. When the CPAP/ BiLevel machine is turned on and functioning properly, new air from the CPAP/BiLevel machine flushes the exhaled air out through the mask vent holes. However, when the CPAP/ BiLevel machine is not operating properly, enough fresh air will not be provided through the mask, and exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some cases lead to suffocation.
  - This mask is shipped clean but nonsterile. If disinfected or sterile use is required, follow the disinfection or sterilization procedures described in this document prior to use of the mask.
  - Discontinue use of the mask if patient skin or mucous membrane irritation or allergic reaction develops due to the mask.
  - Failure to arouse and remove the mask after vomiting could result in aspiration of vomitus.
  - If a fixed flow rate of supplemental oxygen is used, the inhaled percent oxygen will vary depending upon the pressure settings, patient breathing pattern, mask size and leak rate. Oxygen flow must be turned off when the CPAP/BiLevel system is not operating.
• Contraindications:
  - A minimum pressure less than 3 cm H20 at mask
  - Open wounds that are prone to infection
  - Hemodynamic or cardiorespiratory instability
  - Unconsciousness
  - Claustrophobia, anxiety, or other discomfort with an Oro-Nasal mask
  - Facial or nasopharyngeal deformity, beard, or other inability to fit mask and seal properly
  - Excessive reflux, GI blood or other secretions
  - Impaired cough reflex, hiatal hernia, or inability to swallow or clear secretions
  - Upper airway obstruction or facial trauma
  - Barotrauma
  - Need for ventilation or ventilatory support more than 12 hours per day
  - Recent facial, esophageal, or gastric surgery
  - Patients unable to remove the mask
  - Patients under medication with a drug that may cause vomiting
  - Patients requiring immediate intubation