Mindray BeneView T1, Руководство оператора

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A-10
A.8.3 SpO
2
Alarm limit Range (%) Step (%)
SpO2 High (low limit + 2) to 100
1 SpO2 Low
Mindray, Masimo: Desat to (high limit – 2)
Nellcor: Desat or 20 (whichever is greater) to (high limit – 2)
Desat 0 to (high limit – 2)
Mindray SpO
2
Module
Standards Meet standards of ISO80601-2-61
*Measurement accuracy verification: The SpO
2
accuracy has been verified in human experiments by comparing with arterial
blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed and about
two-thirds of the measurements are expected to come within the specified accuracy range compared to CO-oximeter
measurements.
SpO
2
measurement range 0 to 100%
PI measurement range 0.05% to 20%
SpO
2
resolution 1%
Response time ≤ 30 s (PI > 0.3, no disturbance, SpO
2
value sudden change within 70% - 100%)
Accuracy
70% to 100%: ±2% (adult/pediatric mode)
70% to 100%: ±3% (neonate mode)
0 to 69%: Not specified.
*Studies were performed to validate the accuracy of Pulse Oximeter with neonatal SpO
2
sensors by contrast with a
CO-Oximeter. Some neonates aged from 1 day to 30 days with a gestation age of 22 weeks to full term were involved in this
study. The statistical analysis of data of this study shows the accuracy (Arms) is within the stated accuracy specification. Please
see the following table.
Sensor type Totally neonates Data Arms
518B 97 (51 male & 46 female) 200 pairs 2.38%
520N 122 (65 male & 57 female) 200 pairs 2.88%
The Pulse Oximeter with neonatal SpO
2
sensors was also validated on adult subjects.
Refreshing rate 1 s
Masimo SpO
2
Module
Standards Meet standards of ISO9919
SpO
2
measurement range 1% to 100%
PI measurement range 0.02% to 20%
SpO
2
resolution 1%
Response time ≤ 20 s (PR 75 bpm, average time 8 s, SpO
2
value rises from 60% to 95%)
Accuracy
1
70% to 100%: ±2% (measured without motion in adult/pediatric mode)
70% to 100%: ±3% (measured without motion in neonate mode)
70% to 100%: ±3% (measured with motion)
1% to 69%: Not specified.
Refreshing rate ≤ 2 s
SpO
2
averaging time 2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s
Low perfusion conditions Pulse amplitude: >0.02%