Indications for use

Intended Use

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. 

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.