Mindray BeneVision N15 Operator's Manual

A - 16 BeneVision N Series Patient Monitor Operator’s Manual
A.15.4 PR Specifications
PR from Mindray SpO
2
Module
PR from Masimo SpO
2
PR from Nellcor SpO
2
Module
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.
Alarm limit Range Step
PR High PR≤40bpm: (low limit + 2 bpm) to 40 bpm
PR > 40 bpm: (low limit + 5 bpm) to 295 bpm
PR≤40: 1
PR>40: 5
PR Low PR≤40bpm: 16 bpm to (high limit - 2 bpm)
PR > 40 bpm: 40 bpm to (high limit - 5 bpm)
Measurement range 20 to 300 bpm
Resolution 1 bpm
Response time <30 s (normal perfusion, no disturbance, PR value sudden changes from 25 to
220bpm)
Accuracy ±3 bpm
Refreshing rate ≤1 s
Sensitivity High, Medium, Low
Measurement range 25 to 240 bpm
Resolution 1 bpm
Response time ≤20 s (with normal perfusion, no disturbance, and a PR value transition from
25 to 220 bpm)
Accuracy ±3 bpm (measured without motion)
±5 bpm (measured with motion)
Refresh rate ≤1 s
Sensitivity High, Medium, Low
Measurement range 20 to 300 bpm
Resolution 1 bpm
Response time ≤30 s (normal perfusion, no disturbance, PR value sudden change from 25 to
250 bpm)
Accuracy 20 to 250 bpm: ±3 bpm
251 to 300 bpm, not specified
Refreshing rate ≤1 s

Mindray BeneVision N15 Specifications

General

Brand	Mindray
Model	BeneVision N15
Category	Medical Equipment
Language	English