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NELLCOR FICTION:

"The Nellcor N-600x is accurate on cyanotic infants from 60% to 100% at plus or minus 3%."

FACTS:

• The documents Nellcor makes available showing clinical validation for its low saturation claims involve tests on healthy adult subjects, not cyanotic patients (infant or older).
• In fact, independent studies on cyanotic infants show that only Masimo with the Blue sensor is accurate and meets its claimed accuracy specification in this population.
• Independent studies show Nellcor's real-world performance in low saturation conditions does not match its published specifications on cyanotic patients.
• Masimo is the only company with FDA cleared claims for accuracy on cyanotic infants.

PROOF:

•  Nellcor Low Sat Testing
•  Comparison of Manufacturer Published Specs vs. Independent Clinical Evaluations
•  New Pulse Oximetry Sensors with Low Saturation Accuracy Claims - A Clinical Evaluation
•  Pulse Oximetry in Children with CHD
•  Masimo's FDA Clearance for the Blue Sensor—Only Sensor FDA Cleared for Cyanotic Infants