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The TAGA Velocity Passover Humidifier with Velocity Humidifier Heater TM1000H is a respiratory positive airway pressure accessory intended to add moisture to the air stream gases for administration to the patient. The humidifier can be used with standard CPAP and or Bi-level Positive Airway Pressure (BiPAP) devices, which have a maximum operating pressure of 20 cm H20, and do not have automatic pressure titration capabilities.

The following is a summary of the Velocity Passover Humidifier component for the new Velocity Humidifier Heater TM1000H device. The non-sterile Velocity Passover Humidifier is a plastic housing comprised of two (2) halves, a top and bottom, assembled together to form an enclosed reservoir. An O-ring forms a seal between the two halves when assembled, with a plurality of slide latches maintaining the proper position and seal tensions between the two housing components. The reservoir has two ports, an inlet and an outlet, on the upper portion, both being 22 mm conical connectors, which allow for the connection of commonly used respiratory Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (BiPAP) flexible tubing. The inlet and outlet port are clearly identified on the device. The inlet port is typically attached to the pressure generating CPAP or BiPAP unit by means of a short piece (12" to 24") of tubing that is supplied with the humidifier. The air entering the humidifier is directed over the surface of the water in the basin through a series of baffles. The design intent of the baffles shape and placement is to create turbulence in the airflow over the water surface. The baffles also create an eddy effect, which in turn increase the duration that the air is exposed and travels across the surface of the water. The combination of both of these effects maximizes the evaporation process thereby elevating the humidity level of the gas before exiting the device. The air exits the device through the outlet port into a second piece of tubing supplied by the user that is connected the patients' mask. The volume of water is sufficient to provide 10 hours minimum use at 70 °F and 25% RH ambient conditions and a patient flow rate of 90 LPM. The humidifier is filled only when removed from the CPAP or BiPAP systems. The Passover Humidifier is used in a horizontal position and will act as a base for most marketed CPAP or BiPAP systems This feature ensures that the water level is below the outlet port on the CPAP or BiPAP systems to eliminate the potential hazard of water reaching any CPAP or BiPAP electrical components. The following is a description for the new Velocity Humidifier Heater TM1000H component of the device. The Velocity Humidifier Heater TM1000H consists of a plastic housing with an On/Off switch, control knob, heater plate assembly and two indicator LEDs. The Velocity passover humidifier rests on the heater plate assembly. The heater plate assembly operates at a scale of low (88°F (31°C)) to high (140°F (60°C)) as selected by the user by adjusting the control knob. The Velocity humidifier heater contains a built-in safety device to prevent the heater plate from reaching excessive temperatures under fault conditions. If the heater plate temperature exceeds approximately 90° C (194° F) power to the unit is terminated. The device has an electrical rating of 110 volts 60Hz, 110 Watts. The device works by heating a metal plate that the plastic humidifier rests on. This in turn warms the water within the humidifier. As the air flows over the water, it picks up some of the moisture. As a result, the gas exiting the humidifier is warmed and humidified providing a continuous humid air stream gas to the patients that require continuous humid positive airway pressure. The system controls the temperature of the heater plate assembly only and not the water or gas temperature.

The TAGA Velocity™ Passover humidifier is a respiratory positive airway pressure accessory intended to add moisture to the airstream gases for administration to the patient. The humidifier increases the vapor content of the air as it passes through the device (Passover) and is directed by the array of baffles over the surface of a body of water. The humidifier can be used with standard CPAP and or Bi-level Positive Airway Pressure (BiPAP) devices which have a maximum operating pressure of 20 cm H2O, and do not have automatic pressure titration capabilities.

The TAGA Velocity Passover Humidifier is a plastic housing comprised of two (2) halves permanently joined to form an enclosed reservoir. The reservoir has two ports, an inlet and an outlet, on the upper portion, both being 22 mm conical connectors, which allow for the connection of commonly used respiratory CPAP flexible tubing. The inlet and outlet port are clearly identified on the device. The inlet port is typically attached to the pressure generating CPAP unit by means of a short piece (12" to 24") of tubing that is supplied with the humidifier. The air entering the humidifier is directed over the surface of the water in the basin through a series of baffles. The design intent of the baffles shape and placement is to create turbulence in the airflow over the water surface. The baffles also create an eddy effect, which in turn increase the duration that the air is exposed and travels across the surface of the water. The combination of both of these effects maximizes the evaporation process thereby elevating the humidity level of the gas before exiting the device. The air exits the device through the outlet port into a second piece of tubing supplied by the user that is connected the patients' mask. The humidifier is filled with distilled or sterile water through either the inlet or outlet ports with the unit held in an upright position. The humidifier has a window with markings to allow the user to fill with the appropriate volume. The unit is manufactured out of a transparent plastic that allows the user to visually verify the volume level at all times. The volume of water is sufficient to provide 10 hours minimum use at 70 °F and 25% RH ambient conditions and a patient flow rate of 90 LPM. The humidifier is filled only when removed from the CPAP system. The humidifier is used in a horizontal position and will act as a base for most marketed CPAP systems. This feature ensures that the water level is below the outlet port on the CPAP system to eliminate the potential hazard of water reaching any CPAP electrical components. The humidifier's moisture gain output exceeds 10mg H2O/L as required by ASTM F1690-96 and ISO 8185:1997. The maximum pressure drop throughout the range of flow rates does not exceed 2kPa per ASTM F1690-96 and ISO 8185:1997. The Velocity humidifier will be cleaned daily by hand washing with a mild dish washing and warm water solution and weekly by soaking in a 25% vinegar/water solution for 30 minutes, both followed by a clean water rinse.