Mindray BeneHeart D2, Operator'S Manual

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A - 10 Defibrillator/Monitor Operator’s Manual
Nellcor SpO
2
Module
A.5.5 PR Specifications
PR from Mindray SpO
2
Module
PR from Masimo SpO
2
Module
PR from Nellcor SpO
2
Module
A.5.6 NIBP Specifications
1
The Masimo pulse oximeter with sensors have been validated for no motion accuracy in human blood studies on healthy
adult volunteers in induced hypoxia studies in the range of 70% to 100% SpO2 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. One percent was added to the accuracies for neonatal sensors to account for accuracy variation due
to properties of fetal hemoglobin.
The Masimo pulse oximeter with 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 non-repetitive motion between 1 to 5 Hz. At an amplitude of 2 to 3 cm in induced hypoxia studies in the range of
70% to 100% SpO2 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.
2
The Masimo pulse oximeter 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.
Standard Meet standards of ISO 80601-2-61
Measurement range 0 to 100%
Resolution 1%
Accuracy 70 to 100%:
70 to 100%:
0% to 69%:
±2% (in adult/pediatric mode)
±3% (in neonate mode)
Not specified
Refreshing rate ≤2 s
Measurement range 20 to 300 bpm
Resolution 1 bpm
Accuracy ±3 bpm
Response time <20 s (PR value sudden changes from 25 to 240 bpm)
Measurement range 25 to 240 bpm
Accuracy ±3 bpm (measured without motion)
±5 bpm (measured with motion)
Response time ≤20 s (PR value sudden changes from 25 to 220 bpm)
Measurement range 20 to 300 bpm
Resolution 1 bpm
Accuracy ±3 bpm (20 to 250 bpm)
Not specified (251 to 300 bpm)
Standards Meet standard of IEC 80601-2-30
Technique Oscillometry
Mode of operation Manual, Auto and STAT