GE Corometrics 250cx Series, Руководство оператора

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17-8 250cx Series Maternal/Fetal Monitor Revision C
2036946-001
Technical Specifications: Operating Modes
Maternal Pulse Oximetry Mode (Masimo continued)
1
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
2
accuracy from 70% to 100%.Pulse Rate accuracy from 25 to 240 bpm.
2
The Masimo SET
®
SpO
2
parameter with LNOP-Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced
hypoxia studies in the range of 70-100% SpO
2
against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus
one standard deviation encompasses 68% of the population.
3
The Masimo SET SpO
2
parameter with LNOP-Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia
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
2
against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus
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.
4
The Masimo SET SpO
2
parameter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo’s simulator with
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
expected to fall within ±
A
rms
of the value measured by a CO-Oximeter.
NOTE:
Use of a functional SpO
2
simulator to assess the accuracy of the Corometrics 250cx SpO
2
parameter has not been demonstrated.
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.
Operating Mode Specifications (Continued)