Indications, Safety, and Warnings

Indications

• 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 2.5mm-9.0mm)

Contraindications

• Do not use the SonarMed™ monitor or leave the SonarMed™ sensor connected to the ETT in an MRI environment. 
• Do not use the SonarMed™ system on a cuffless ETT for ID sizes between 4.0 mm and 9.0 mm. The SonarMed™ system is intended for use only with a cuffed ETT for this size range. 
• Do not use on patients who require an ETT smaller than 2.5 mm ID.
• Do not use the SonarMed™ system on patients ventilated with Heliox. 
• Do not use in a setting other than in-hospital. 
• Do not attempt to re-use or sterilize the sensor; infection or cross-contamination is possible. Sterilizing the sensor may cause damage to the internal components, which can cause the SonarMed™ system to produce erroneous results.

The SonarMed™ airway monitoring system (monitor and sensor) is not to be used as a diagnostic tool; it is to be used as an adjunct to airway management only.