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The SonarMed AirWave Airway Monitoring System is used to assist in verifying placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, to assist in detecting obstruction of the ETT, and to assist in listening to breath sounds. The SonarMed AirWave Airway Monitoring System is intended for use by qualified personnel to assist with artificial airway management for patients in an in-hospital setting (intensive care, operating room, and emergency department settings, as well as intra-hospital transport). The SonarMed AirWave Airway Monitoring System is to be used as an adjunct to normal clinical practice and is a not a stand-alone diagnostic system. It is intended for use with neonates, infants, children, adolescents, and adults (sizes 2.5 mm to 9.0 mm).

The SonarMed AirWave is comprised of a SonarMed Monitor (Monitor) that is used in conjunction with a single-patient use SonarMed Sensor (Sensor) and software that operates the Monitor and Sensor. The Monitor is powered from an external power supply and has a battery backup. When in use, the SonarMed Sensor is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube (ETT) of a patient who is connected to a ventilator. Using acoustic reflection technology, signals from the Sensor are displayed on the Monitor showing the clinician: - The baseline location of the ETT tip as established by the clinician - Estimation of passageway around the tipof the ETT, relative to the . ETT diameter - ETT movement relative to the baseline location ● - . ETT occlusion / obstruction information including percent obstructed and location of the obstruction - The clinician can choose whether to view information about the . patient's airway in either a waveform or graphic on the Monitor's LCD. Additionally, the clinician can use the microphones to listen to breath sounds. The information provided by the device is to be used in conjunction with normal clinical practice to assist with management of the artificial airway of the patient.

The SonarMed AirWave Airway Monitoring System is used to assist in verifying placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, to assist in detecting obstruction of the ETT, and to assist in listening to breath sounds. The SonarMed AirWave Airway Monitoring System is intended for use by qualified personnel to assist with artificial airway management for patients in an in-hospital setting (intensive care, operating room, and emergency department settings, as well as intra-hospital transport). The SonarMed AirWave Airway Monitoring System is to be used as an adjunct to normal clinical practice, and is not to be used as a stand-alone diagnostic system. It is intended for use with patients who use ET tube sizes 2.5, 3.0, 3.5, and for sizes 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0 mm.

The SonarMed AirWave is comprised of a SonarMed Monitor (Monitor) that is used in conjunction with a single-patient use SonarMed Sensor (Sensor) and software that operates the Monitor and Sensor. The Monitor is powered from an external power supply and has a battery backup. When in use, the SonarMed Sensor is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube (ETT) of a patient who is connected to a ventilator. Using acoustic reflection technology, signals from the Sensor are displayed on the Monitor showing the clinician: • The baseline location of the ETT tip as established by the clinician • Quantification of diameter of the anatomical structure around the tip of the ETT • ETT movement relative to the baseline location - ETT occlusion / obstruction information including percent obstructed and location of the obstruction The clinician can choose whether to view information about the patient's airway in either a waveform or graphic on the Monitor's LCD. Additionally the clinician can use the microphones to listen to breath sounds. This information should only be used in an adjunctive manner to assist with management of the artificial airway of the patient. The monitor allows the user to manually adjust the sound of speed. This is to compensate for the changes in the sound of speed with high oxygen concentrations and the use of anesthesia gases. The monitor also has an auto-speed of sound mode. This mode automatically changes the speed of sound. The monitor allows the user to manually enter the distance to the carina from the chest x-ray. This is an optional feature that the user can elect from the setting menu. Once selected the algorithm will calculate the distance to the carina based on the movement of the tip of the tube.

The SonarMed™ AMS is used to assist in verifying placement of the endotracheal tube (ETT), to assist in detecting movement of the ETT tip, and to assist in detecting obstruction of the ETT. The SonarMed AMS is intended for use by qualified personnel to assist with artificial airway management for patients in an in-hospital setting (intensive care, operating room, and emergency department settings, as well as intra-hospital transport). The SonarMed AMS is to be used as an adjunct to normal clinical practice, and is not to be used as a stand-alone diagnostic system. It is intended for use with patients who use ET tube sizes from 6.5 mm to 9.0 mm, with a body weight of >35 kg.

The SonarMed AMS is comprised of a SonarMed Monitor (Monitor) that is used in conjunction with a sterile, single-use SonarMed Adapter (Adapter) and software that operates the Monitor and Adapter. The Monitor is powered from an external power supply and has a battery backup. When in use, the SonarMed Adapter is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube (ETT) of a patient who is connected to a ventilator. Using sonic reflection technology, signals from the Adapter allow the color LCD on the Monitor to display to a clinician: The baseline location of the ETT tip as established by the clinician Quantification of passageway diameter relative to the ETT diameter (for example a reading of less than 1 may indicate the tube is in a passageway that is smaller than itself, such as the esophagus) ETT movement relative to the baseline location ETT occlusion / obstruction information including percent obstructed The clinician can choose whether to view information about the patient's airway in either a waveform or graphic on the Monitor's color LCD. This information should only be used in an adjunctive manner to assist with management of the artificial airway of the patient.