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The 6500 Series V2masks are disposable, single-patient-use, adult oro-nasal masks intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to continuous ventilators which have adequate alarms and safety systems for ventilator failure. The masks are specifically indicated for use on adult patients (> 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. The 6600 Series V2masks are disposable, single-patient-use, adult oro-nasal CPAP/NIPPV masks which incorporate passive, continuous flow exhaust ports into the mask itself. They are intended for use with certain CPAP 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. The masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures >3.0 cm H20 at the mask) in homes, hospitals, 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. The 6700 Series V2masks are disposable, single-patient-use, adult oro-nasal CPAP/NIPPV masks without any passive, continuous flow exhaust port built into the mask. They are intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that incorporate the patient vent into the patient circuit instead of the mask. These masks provide a minimum of 3 cm H20 pressure measured at the mask. The masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures >3.0 cm H20 at the mask) in homes, hospitals, 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.

The Disposable Single-Patient-Use Oro-Nasal V2mask™ devices consist of the following basic components: 1. Mounting Head Gear 2. Face Piece 3. Swivel Port Assembly. The Face Piece and the Swivel Port Assembly are cleanable and are disposable after 7 days of singlepatient treatment. However, they are not reusable after this time. The Mounting Head Gear is also cleanable and disposable after multiple uses. The Mounting Head Gear which comes in two sizes has straps which are adjustable in both length and tension. It holds the Face Piece against the patient's face to prevent any gas leakage. The Elbow of the Swivel Port Assembly for the 6600 Series V2masks™ incorporate a series of vent holes to provide a continuous air leak to flush out the dead space CO2 and prevent it from being rebreathed by the patient during CPAP or noninvasive positive pressure ventilation (NIPPV) therapy using the required single-limb patient circuit. The Face Piece for all sizes of the 6500 and 6700 Series V2masks™ are nonvented. They do not incorporate vent holes in the Elbow. However, the 6500 Series requires the incorporation of a an active exhalation valve into the expiratory limb of the patient circuit used with the continuous ventilation device providing the noninvasive ventilation. The 6700 requires the incorporation of an exhaust valve into the single-limb patient circuit of the CPAP or NIPPV device. This provides the required air flow to flush out the dead space CO2 and prevent it from being rebreathed. The Swivel Port Assembly for the 6600 Series and the 6700 Series V2masks™ consists of the following pieces: 1. Mask Adapter 2. Elbow with Ant--Asphyxia Valve (AAV) 3. 22 mm OD Swivel Port. The AAV functions as a safety mechanism which allows the patient to breathe fresh air if the NIPPV or CPAP output ceases. It allows a minimum IPAP, EPAP or CPAP pressure of 3 cm H20. The 6500 Series V2mask™ Swivel Port Assembly consists of the same pieces except the Elbow does not incorporate an AAV. The safety mechanism provided by an AAV is already provided by the continuous ventilator which would recognize an AAV in the mask as a patient circuit leak.

The Hans Rudolph 7600 Vmask series are reusable, multi-use, adult Oro-Nasal CPAP/NPV masks which incorporate a passive, continuous flow exhaust port at the patient connection. They are intended for use with certain CPAP 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 H2O pressure measured at the mask. The Masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures ≥ 3.0 cm H2O at the mask) in homes, hospitals, 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.

7600 Series Multi-Patient Multi-Use Oro-Nasal CPAP/NPPV Masks consists of the following components: 1. Mounting Head Gear 2. Face Piece with Vent Holes 3. Swivel Port Assembly The Face Piece and the Swivel Port Assembly are both sterilizable and reusable by multiple patients. The Mounting Head Gear is disposable after multiple uses by a single patient only. The Mounting Head Gear is adjustable in both its size and tension and holds the Face Piece against the patient's face to prevent any gas leakage. The size range of adjustment have been determined by a Mask Human Factors Study. The Mounting Head Gear also holds both the Face Piece and the Swivel Port Assembly onto the patient's head and is capable of adjusting to varying head sizes as determined by the Mask Human Factors Study. The physical properties and dimensional ranges of the Face Piece (Mask) sizes listed under section #3 above have been determined by a Mask Human Factors Study. All Face Piece sizes incorporate a series of vent holes in the area of the nose to provide a continuous air leak to flush out the dead space CO2 and prevent it from being rebreathed by the patient. The incorporation of these holes do not interfere with the other performance requirements of the 7600 Series Mask. The vent holes also function to allow the patient to exhale normally. The Swivel Port Assembly consists of the following pieces: 1. Mask Adapter 2. Elbow with Anti-Asphyxia Valve 3. 22 mm Swivel Port The 22 mm Swivel Port is sized to connect to all standard CPAP or ventilation device tubing types. The Elbow provides 360° of swivel rotation both at the Mask Adapter and at the 22 mm Swivel Port. The Anti-Asphyxia Valve is detachable from the Elbow for cleaning, sterilization and replacement. The Anti-Asphyxia Valve functions as a safety mechanism which allows the patient to breathe fresh air if the CPAP or ventilation device output ceases.

The Hans Rudolph 7600 Vmask series is a reusable, single patient multi-use, adult Full-Face CPAP/NIPPV mask which incorporates a passive, continuous flow exhaust port at the patient connection. It is intended for use with certain CPAP 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 cmH20 pressure measured at the mask. The Masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures ≥ 3.0 cm H2O at the mask) 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 and system to which the masks are intended to connect.

The 7600 Series Reusable Full-Face CPAP/NIPPV Masks consists of the following components: 1. Mounting Head Gear 2. Face Piece with Vent Holes 3. Swivel Port Assembly The Face Piece and the Swivel Port Assembly are both sterilizable and reusable. The Mounting Head Gear is disposable after multiple uses. The Mounting Head Gear is adjustable in both its size and tension and holds the Face Piece against the patient's face to prevent any gas leakage. The size range of adjustment have been determined by a Mask Human Factors Study. The Mounting Head Gear also holds both the Face Piece and the Swivel Port Assembly onto the patient's head and is capable of adjusting to varying head sizes as determined by the Mask Human Factors Study. The physical properties and dimensional ranges of the Face Piece (Mask) sizes listed under section #3 above have been determined by a Mask Human Factors Study. All Face Piece sizes incorporate a series of vent holes in the area of the nose to provide a continuous air leak to flush out the dead space CO2 and prevent it from being rebreathed by the patient. The incorporation of these holes do not interfere with the other performance requirements of the 7600 Series Mask. The vent holes also function to allow the patient to exhale normally regardless as to whether he or she is connected to single or dual level CPAP system or an MNT. MNS or CBK ventilator and regardless of the make or model of the CPAP or MNT. MNS or CBK ventilator blower device being used. The Swivel Port Assembly consists of the following pieces: 1. Mask Adapter 2. Elbow with Anti-Asphyxia Valve 3. 22 mm Swivel Port The 22 mm Swivel Port is sized to connect to all standard CPAP or MNT, MNS or CBK ventilator blower tubing types. The Elbow provides 360° of swivel rotation both at the Mask Adapter and at the 22 mm Swivel Port. The Anti-Asphxyia Valve is detachable from the Elbow for cleaning, sterilization and replacement. The Anti-Asphxyia Valve functions as a safety mechanism which allows the patient to breathe fresh air if the CPAP or MNT, MNS, or CBK ventilator blower output ceases.