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A.8.4 SpO
2
Specifications
Mindray SpO
2
Module
Masimo SpO
2
Module
Standard Meet standards of ISO 80601-2-61
Measurement range 0 to 100%
Resolution 1%
Response time < 30 s (normal perfusion, no disturbance, SpO
2
value sudden changes from
70% to 100%)
Accuracy* 70% to 100%:
70% to 100%:
0 to 69%:
±2%ABS (adult, pediatric)
±3%ABS (neonate)
not specified
Refreshing rate ≤1 s
* One percent was added to the accuracies for neonatal sensors to account for accuracy variation due to properties of fetal
hemoglobin. 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.
PI
Measurement range 0.05 to 20%
Resolution 0.05% to 9.99%:
10.0% to 20.0%:
0.01%
0.1%
CQI
Display range 0 to 100
Resolution 1
Rate
Display range 20 to 300 cpm
Accuracy range 40 to 160 cpm
Accuracy ±3 cpm
Resolution 1 cpm
Standard Meet standards of ISO 80601-2-61
Measurement range 1% to 100%
Resolution 1%
Response time ≤20 s (normal perfusion, no disturbance, SpO
2
value sudden changes from
70% to 100%)
Accuracy
1
70% to 100%: ±2%ABS (measured without motion in adult/pediatric mode)
70% to 100%: ±3%ABS (measured without motion in neonate mode)
70% to 100%: ±3%ABS (measured with motion)
1% to 69%: not specified
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