Avisa BreathTestTM Procedure

The Avisa BreathTestTM has the following steps to perform a measurement:

  1. Retrieve and open the Avisa BreathCollection kit
  2. Turn on AVISAR SPEC, connect breath collection cannula to instrument and place on patient
  3. Collect a baseline breath sample from patient by pressing START on AVISAR SPEC
  4. Mix the AV-U13 drug with 3 mL of sterile water provided in kit
  5. Fill the nebulizer cup with AV-U13 solution and connect nebulizer control cable to AVISAR SPEC
  6. Start nebulization by pressing NEB on AVISAR SPEC
  7. Observe patient for proper breathing technique as patient inhales AV-U13 mist from nebulizer
  8. At end of nebulization, AVISAR SPEC collects patient breath and reports change from baseline
  9. Remove cannula from patient and dispose of cannula, nebulizer, syringe and drug container
  10. Note result in medical record, elevated results indicate active infection with urease pathogen

The Avisa BreathTestTM is currently an investigational device and has not yet been approved by the FDA for commercial use.