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 Green
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 7500 Series V2 Masks™ are reusable, multi-patient-use, adult
oro-nasal masks intended to provide a patient interface for application of noninvasive ven-
tilation. The masks are to be used as an accessory to continuous ventilators which have
adequate alarms and safety systems for ventilator failure.
• Indications for Use & Environment: The masks are specifically indicated for use on
adult patients (greater than 30 kilograms weight) to administer positive pressure ventilation
for treatment of respiratory failure or respiratory insufficiency. They are intended for use on
patients who are appropriate candidates for noninvasive ventilation, in the home, hospital,
or 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 and system to which the masks are
intended to connect.
• Cautions:
a.) Federal law restricts this device to sale by or on the order of a physician.
b.) Patients with facial hair, especially beards, may experience mask leakage which may require shaving the hair.
• Warnings: Refer to: Instructions for Use, Document No. 691271, shipped with product.
• Contraindications & Complications: Refer to: Instructions for Use, Document No. 691271, shipped with product.
MASK SIZE WITH OVERALL DIMENSIONS – inches (mm)
Elbow Swivel Port Straight Swivel Port
A B c A B c
Large 5.9 (150) 4.2 (107) 4.71 (120) 5.9 (150) 4.2 (107) 4.53 (115)
Medium 5.5 (140) 4.16 (105) 4.46 (113) 5.5 (140) 4.16 (105) 4.28 (109)
Small 5.2 (132) 4.31 (109) 4.05 (103) 5.2 (132) 4.05 (103) 4.12 (105)
X-Small 4.8 (122) 3.95 (100) 4.21 (107) 4.8 (122) 3.95 (100) 4.04 (103)
Petite 4.6 (117) 3.9 (99) 4.05 (103) 4.6 (117) 3.9 (99) 3.92 (100)
