Clinical Studies
Operator’s Manual Addendum
ADD-31
1.11.4
Adverse Events
No adverse events were reported during the studies.
1.11.5
Conclusion
In clinical studies of healthy subjects and hospitalized patients, Respiration Rate,
Version 2.0 provided respiration rate with an accuracy of ± 1 breath per minute
when compared to respiration rate derived from a capnography-based reference.
Hospital studies did not necessarily include all patient conditions found in hos-
pitals and hospital-type settings. These clinical study results may not generalize
to all patient conditions.