62
At the nominal value of 3 ppb, the overall mean measured value was 3.42 ppb (95% CI 3.29;3.55). At
the nominal value of 5 ppb, the overall mean measured value was 5.42 ppb (95% CI 5.29;5.55) which
supports the claimed detection limit of 5 ppb in adult mode.
At the nominal value of 3 ppb, the overall mean measured value was 3.61 ppb (95% CI 3.49;3.76). At
the nominal value of 5 ppb, the overall mean measured value was 5.47 ppb (95% CI 5.32;5.61) which
supports the claimed detection limit of 5 ppb in child mode.
Interpretation of FeNO Values
For interpretation of FeNO values, please refer to the ATS Clinical Practice Guideline at
https://www.thoracic.org/statements/resources/allergy-asthma/feno-document.pdf
Warranty
MGC Diagnostics Corporation warrants the FeNObreath™ monitor and sensor to be free of defects in
materials and workmanship for a period of 5 years from the date of shipment, subject to service and
maintenance requirements. MGC Diagnostics Corporation’s sole obligation under this warranty is
limited to repairing or replacing, at its choice, any item covered under this warranty when such an
item is returned intact and prepaid, to MGC Diagnostics Corporation or the local, fully trained,
representative. This service and maintenance requirement includes performing an annual calibration
on the monitor within 60 days of the first notification that the device is due for calibration. The
service also includes the replacement of the NO scrubber. Annual calibration can be performed by
