Adverse Events or Deviations
Conclusion
N-600x Operator's Manual
The study was conducted as expected with no adverse events and
no deviations from the protocol.
The pooled results indicate that for a saturation range of 60-80%
for SpO
, the acceptance criterion was met for the monitoring
2
system when tested with MAX-A, MAX-N and MAX-FAST
sensors. The pooled results indicate that for a saturation range of
70-100% for SpO
, the acceptance criterion was met.
2
Clinical Study
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