A-5
Alarm limit Range (%) Step (%)
SpO
2
High (low limit + 2) to 100
1
SpO
2
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 ISO 80601-2-61
*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%
Accuracy
70 to 100%: ±2% (measured without motion in adult/pediatric
mode)
70 to 100%: ±3% (measured without motion in 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
Response time
≤ 30 s (PI > 0.3, no disturbance, SpO
2
value sudden change
within 70% - 100%)
Masimo SpO
2
Module
Standards Meet standards of ISO 80601-2-61
SpO
2
Measurement range 1 to 100%
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