A - 9
A.6.1.2 Masimo SpO
2
Module Specifications
PI Resolution PI < 10.0: 0.01
PI ≥ 10.0: 0.1
Accuracy 70 to 100%: ±2% ABS (adult/pediatric)
70 to 100%: ±3% ABS (neonate)
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 (normal perfusion, no disturbance, SpO
2
value sudden
change within 70% – 100%)
Standards meets the requirements of ISO 80601-2-61
SpO
2
Measurement range 1 to 100%
PI Measurement range 0.02 to 20%
SpO
2
Resolution 1%
PI Resolution PI < 10.0: 0.01
PI ≥ 10.0: 0.1
Accuracy
1
70% to 100%: ±2% ABS (without motion, adult/pediatric)
70% to 100%: ±3% ABS (without motion, neonate)
70% to 100%: ±3% ABS (with motion)
1% to 69%: Not specified.
Refreshing rate ≤ 1 s
Response time ≤20 s (normal perfusion, no disturbance, SpO
2
value
sudden change within 70% – 100%)
SpO
2
averaging time 2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s
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