Search Results

The DeVilbiss DV5MB SmartLink II System can only be used in conjunction with the DeVilbiss DV51, DV53, DV54, DV55, DV56, and DV57 Series CPAP Systems for follow up of obstructive sleep apnea in patients weighing above 30 kg on nasal CPAP therapy. The system is to be used in home and healthcare environments.

The proposed DeVilbiss DV5MB SmartLink II System is an accessory to DeVilbiss IntelliPAP DV5x Series CPAPs, models DV51, DV53, DV54, DV55, DV56 and DV57. The proposed DeVilbiss DV5MB SmartLink II System connects physically and electrically to a DV5x Series CPAP for the purpose of collecting usage and performance data from the CPAP for subsequent download to PC software for storage, viewing and reporting. The proposed DeVilbiss DV5MB SmartLink II System is identical to the predicate device with the addition of a Bluetooth Wireless connection. The Bluetooth radio used is a complete Bluetooth module with built in antenna and Bluetooth v2.1 + EDR. The maximum output power of the Bluetooth radio is +2.5 dBm, has a maximum range of 10 meters. The DeVilbiss DV5MB SmartLink II System wireless feature can be used in the home or in a healthcare setting.

The DeVilbiss IntelliPAP/SleepCube Model DV57 Series Auto Bilevel is intended for use in treating OSA in spontaneously breathing patients 30 Kg and above by means of application of positive air pressure. The Device is to be used in home and clinical environments.

The role of the product from a patient's point of view is to provide a continuous source of bilevel positive airway pressure for the treatment of sleep apnea. Positive airway pressure is applied to the oropharynx to act as a pneumatic splint to prevent the collapse of the pharyngeal muscle, which occludes the patient airway during sleep. Auto Bilevel units are used over conventional CPAP units due to high pressures and/or patient intolerance to continuous pressure, making exhalation difficult. The proposed DeVilbiss DV57 Auto Bilevel product is an addition to the sleep product line. The proposed Auto Bilevel device combines the functions of traditional (predicate) Bilevel and (predicate) Auto Adjust CPAP to provide bilevel pressure support therapy that responds to detected events and adjusts the IPAP pressure setting as the patient demand requires. The level of pressure support, difference between IPAP and EPAP is maintained at a level prescribed by a doctor. Automatic and manual inhale/exhale trigger sensitivity is to be provided to allow the clinician to customize trigger parameters for specific operating conditions. The DeVilbiss Intellipap/SleepCube Auto Bilevel product is not intended to meet the needs for the "ventilator" market, which necessitates features such as alarms, higher operating pressures and other ventilator specific functions