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The VELA Ventilator is intended to provide continuous or intermittent respiratory support in an institutional health care environment (e.g. hospitals) for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use only by qualified trained personnel under the direction of a physician. It may be used on adult and pediatric patients. Specifically, the ventilator is applicable for adult and pediatric patients weighting at least 5 kg (11lb), who require the following types of ventilation support, as prescribed by an attending physician. - Positive pressure ventilation - Assist / control, SIMV, or CPAP modes of ventilation The ventilator is suitable for use in institutional and transport settings. It is not intended of use in an emergency medical transport ventilator or for home care applications.

A VELA with the CO2 monitoring option is intended to monitor the effectiveness of ventilation. It may be used on adult and pediatric patients. It is suitable for use in a hospital critical care environment, and is a restricted medical device intend for use by qualified trained personnel under the direction of a physician. The VELA Series Ventilator is a modified Tbird Ventilator and like its predecessor, is an easy to use, self-contained, servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for pediatric through adult patients. Its revolutionary user interface module provides maximum flexibility with simple operator interaction. It has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for easy interaction, membrane keys and a dial for changing settings and operating parameters. A precision gas delivery turbine with servo controlled active inhalation and exhalation improves performance over previous generations. The VELA Series Ventilator may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It is easy to clean and its design does not allow liquids to pool on the casing, reducing the likelihood of fluid leakage into the body of the ventilator. The VELA Series Ventilator base model comes with comprehensive features for the critical care environment. Optional features can be added at time of purchase or at a later date.

The Heliox Low Flow Sentry Blender is designed to provide a continuous heliox/oxygen qas mixture to infant, pediatric, and adult patients. It is intended as a device to mix an 79% Helium / 21% Oxygen gas source with a 100% oxygen gas source to provide low flow mixtures containing 20% to 100% oxygen with the balance of the gas being Helium for patients who are spontaneously breathing. It is a medical device intended for use by qualified, trained personnel, under the direction of a physician, in institutional environments where the delivery and monitoring of helium/oxygen mixture is required.

The helium/oxygen and oxygen blender/monitor combines a precision helium/oxygen (79%/21%) and oxygen mixing valve with an integral battery operated oxygen concentration analyzer and user adjustable alarms.

The Puresom Nasal (CPAP) Mask system is for use with continuous positive airway pressure devices (CPAP), operating at or above 3cmH2O for the treatment of obstructive sleep apnea. The mask is intended for single patient use and can be used in the home or in a hospital/ institutional environment. The mask is to be used on adult patients (>30Kg) for whom continuous positive pressure airway has been prescribed.

The Puresom Nasal (CPAP) Mask is intended to be used with positive airway pressure devices such as CPAP. It provides a seal such that positive pressure from positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with a mild detergent, such as Ivory® dishwashing liquid or unscented baby shampoo in water. The design consists of latex-free silicone cushion designed to fit over the patients' nose. The cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. The cushion shall be connected to a polycarbonate frame that supports the cushion and provides a connection for a 90º elbow. The elbow shall be capable of rotating freely through 360º. The silicone cushion is designed in such a way that it can be easily removed by the patient, from the polycarbonate frame for cleaning or replacement purposes. The elbow connects to a conventional air delivery hose between the mask and the positive airway pressure source via a 22mm polycarbonate fitting on the elbow. The 22 mm connector is designed in such a way that it can rotate freely through 360º. The built in vent openings are molded into the front side of the elbow and a snap-on shroud is assembled to the elbow to direct the air away from the patient's face and chest. The vent openings may be visually inspected for obstruction prior to use.

The ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is disposable and for single patient use. It is for use on adult patients (> 30 kg), who are appropriate candidates for noninvasive ventilation and use in a hospital/institutional environment.

THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask provides a seal around the nose and mouth such that pressure from a positive pressure source is directed into the patient's nose and mouth. It is held in place with an adjustable headgear. The design consists of latex-free silicone cushion connected to a molded polycarbonate frame with an elbow that can swivel 360°. The elbow shall have an interconnection mating with the tubing from the positive pressure device. The interconnection shall conform to ISO 5356-1 (EN1281-1) with a 22mm female connector that can also swivel through 360°. This mask can be used to deliver positive pressure therapy to patients requiring pressures up from 3 to 40 cmH2O. This mask can be used with a range of devices that provide a low level of pressure and that have a mechanism to adequately remove exhaled gases as well as a safety valve that opens to atmosphere to provide room air in the event of loss of supply pressure. THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is functionally similar to Cardinal Health Advantage Series Full Face mask (K043382) except that it does not have the anti-asphyxia or an exhalation port. Due to the fact that this is a non-vented mask, there is a need for a separate mechanism to remove exhaled gases.

The AVEA Ventilator is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should be operated by properly trained clinical personnel, under the direction of a physician.

The AVEA Ventilator is a fourth generation servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its revolutionary user interface module (UIM) provides maximum flexibility wit6h simple operator interaction. It has a flat panel color LCD with real time graphic displays and digital monitoring capabilities, a touch screen for easy interaction, membrane keys and a dial for changing settings and operating parameters. A precision gas delivery engine with servo controlled active inhalation and exhalation improves performance over previous generations. The only design change is an optional Disposable Expiratory Filter / Water Trap to be used exclusively with the AVEA Ventilator.