GE Corometrics 250cx Series Operator's Manual page 188

Maternal Pulse Oximetry Mode (Masimo continued)
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Accuracy specified when used with Masimo SET pulse oximetry modules using PC or LNC series patient cables. Numbers represent ± 1 standard deviation.Plus or minus
one standard deviation represents 68% of the population.SpO
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The Masimo SET SpO parameter with LNOP-Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced
®
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hypoxia studies in the range of 70-100% SpO
one standard deviation encompasses 68% of the population.
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The Masimo SET SpO parameter with LNOP-Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia
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studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non repetitive motion before 1 to 5 Hz at an amplitude of 2 to 3 cm in
induced hypoxia studies in the range of 70-100% SpO
or minus one standard deviation encompasses 68% of the population. Masimo SET technology with LNOP and LNCS sensors have been validated with
human blood studies on healthy adult volunteers with induced hypoxia studies. The volunteer population composed of both men and women spanned a range of skin
pigmentations from light to dark and ranged in age from 22 to 40 years old.
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The Masimo SET SpO parameter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with
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signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus, one standard
deviation. Plus or minus one standard deviation encompasses 68% of the population.
NOTE: Because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of pulse oximeter equipment measurements can be
A
expected to fall within ± of the value measured by a CO-Oximeter.
rms
NOTE: Use of a functional SpO
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This device is covered under one or more of the following US Patents:5,482,036;5,490,505;5,632,272;5,685,299; 5,758,644; 5,769,785; 6,002,952; 6,036,642; 6,067,462;
6,206,830; 6,157,850 and international equivalents. USA and international patents pending.
17-8
Technical Specifications: Operating Modes
Operating Mode Specifications (Continued)
accuracy from 70% to 100%.Pulse Rate accuracy from 25 to 240 bpm.
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against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus
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against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus
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simulator to assess the accuracy of the Corometrics 250cx SpO
250cx Series Maternal/Fetal Monitor
parameter has not been demonstrated.
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2036946-001
Revision C