The Microstream™ capnography monitoring system should not be used as the sole basis for diagnosis or therapy and is intended only as an adjunct in patient assessment.
The recommendations of using Microstream, Nellcor, and Vital Sync in the management of COVID-19 are not cleared by FDA. This labeling has been introduced into the US market through enforcement discretion leveraging FDA guidelines supporting the COVID-19 public health emergency and this pathway can only be utilized for the duration of the emergency. These devices are considered adjunctive technology and should not be solely or primarily relied upon to prevent, diagnose, or treat COVID-19 or co-existing conditions.
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