Description
SPECIFICATIONS
MATERIALS (See Fig. A)
Face Piece with Structural Braces Silicone Rubber, Polycarbonate Thermoplastic
Swivel Port – Mask Adapter, Elbow, 22mm Port Polycarbonate Thermoplastic, Translucent Blue
Swivel Port – AAV Port Polycarbonate Thermoplastic Translucent
Diaphragm Silicone Rubber
Headgear Polyurethane Foam Black, Nylon UBL Gray and
Nylon Fabric Red
Headgear Hook Nylon, Black
Headgear Strap Clips (4), Tri-glide Polypropylene, Black
GENERAL INFORMATION
• Intended Use:
The Hans Rudolph 7600 V2 Mask™ series are reusable, multi-patient use, adult Oro-Nasal CPAP/BiLevel mask which incorporates passive,
continuous flow exhaust port 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 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 BiLevel pressures the flow through the patient circuit 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 to: Instructions for Use, Document No. 691270, shipped with product.
• Contraindications & Complications: Refer to: Instructions for Use, Document No.
691270, shipped with product.
PHYSICAL CHARACTERISTICS
Face Mask Dimensions
ORDERING INFORMATION – 7600 Series Reusable V2 Oro-Nasal Mask with Elbow Swivel Port 22mm OD Vented with Anti-Asphyxia Valve (AAV) & Headgear (HG)
P/N Description
Mask, AAV Valve, Vented 22mm OD Elbow with HG
113485 7600 Large
113486 7600 Medium
113487 7600 Small
113488 7600 Extra Small
113489 7600 Petite
Replacement Parts
669180 Face Piece Large
669181 Face Piece Medium
669182 Face Piece Small
669183 Face Piece Extra Small
669184 Face Piece Petite
201494 Headgear Large (Use with Large Mask)
201493 Headgear Medium (Use with Medium and Small Mask)
201492 Headgear Small (Use with XSmall and Petite Mask)
201523 Swivel Port, AAV, Non-Vented, 22mm OD
201555 HG Strap Clips package of four & Tri-glide
201521 AAV Port assembly
211022 Cap Plugs for sampling port package of two
Accessories
691143 Mask Sizing Gauge for V2 Oro-Nasal Masks
669353 METRO™ NG Tube Seal Disposable Package of 1