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The 3B and BMC RESmart CPAP and Auto-CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.

The BMC RESmart™ CPAP System (Private labeled in the USA as the "3B CPAP System") and the BMC RESmart" Auto CPAP System (Private labeled in the USA as the "3B Auto CPAP System") are microprocessor controlled, blower-based systems that generate positive airway pressures from 4-20 cm H2O. The devices are intended for use with a patient circuit that is used to connect the device to the patient interface, i.e., the mask. The CPAP and Auto CPAP devices consist of a blower, pressure/flow monitoring, pressure controlling, user interface and optional heated humidifier. The air blower consists of a DC brushless motor, turbofan, and shell, Fresh air is sucked in via an inlet due to the vacuum created by the air blower. The inlet foam filters dust and other floating particles. The filtered air is compressed to a certain pressure and blown out via an outlet. The outlet pressure is determined by the motor rate speed, which is controlled by the pressure control system. The device has a real time pressure/flow monitoring system. Sensors monitor the outlet air pressure/flow, providing feedback, which is used to control the rate of speed of DC brushless motor, which regulates outlet air pressure in real time. The leakage of the mask and tubing will lead to a decrease of the outlet air pressure. This can be detected by the monitoring system and feedback allows the pressure controlling system to modify the rate speed of motor. In this way, the lost pressure caused by leakage will be compensated. When system is in standby, the pressure/flow change caused by respiratory via mask will also be detected by monitoring system and the automatically turning on of the function will be achieved. Pressure/flow changes caused by removal of the mask and/or tubing will also be detected, triggering the device alert and stopping the pressure output of the device. Device control, setting and system status are displayed and achieved by user interface including buttons and LCD. The backlit LCD can display the system status and parameters. The buttons consist of start/stop, humidifier, ramp and +/- user buttons. User and medical equipment vendor service personnel can control and set the device via these buttons. The two models bundled into this 510(k) submission (RESmart© CPAP and Auto CPAP) are mechanically identical. The difference in functionality is determined by the software. In the standard CPAP model, the automated pressure regulation module of the software is disabled. The CPAP System provides only one level of pressure. In contrast the Auto CPAP provides varying levels of pressure that automatically adjusts, based on the patient's needs. The pressure required to overcome obstruction may vary, based upon body position, sleep stage, weight, neck size, congestion, or other factors. The Auto CPAP System will adjust the pressures throughout the night as the patient's pressure requirements change. The Auto CPAP System will maintain an optimal pressure, which, in most cases, will be lower that the pressure provided by the CPAP System. No mask is included with the device, and the mask must be purchased separately. The integrated humidifier is optional. It also is packaged and sold separately. This humidifier moistens the air delivered by the CPAP and Auto CPAP Systems. It is used only on a single patient and must not be re-used on another person in order to avoid the risk of cross-infection. The heated humidifier is used to increase the outlet air temperature and humidity. The humidifier is an optional component packaged and sold separately, but when added, is integrated by simple snap in place mechanism to the CPAP device. The humidifier consists of a heated platform and water chamber. The water is heated, which raises the temperature and humidity of the air in contact. The humidifier is controlled via infrared port and powered by the main device. The temperature sensors ensure the desired temperature and safety. The RESmart CPAP and Auto CPAP devices are mechanically identical. The two devices operate on the same principles; utilize the exact same components and circuit, design, and manufacturing approach. The only difference consists of the software algorithm driving the fan controller board. A summary of the software algorithm is attached to the Appendix. The output treatment pressure of the CPAP device is set by the physician and fixed. By contrast, the pressure delivered in an Auto CPAP device is adjusted automatically in real time by the Auto CPAP system by tracking patient's respiration and airflow. The RESmart CPAP and Auto CPAP, and integrated humidifier, complies with IEC 60601-1 and EN ISO 17510-1