
A-5
Sensor type Totally neonates Data Arms
520N 122 (65 male & 57 female)
200 pairs 2.88%
518B 97 (51 male & 46 female) 200 pairs 2.38%
This monitor with neonatal SpO2 sensors was also validated on adult subjects.
Update period 1s
Averaging time 7s
PR
Measurement range 20 to 254bpm
Resolution 1bpm
Accuracy ±3 bpm (in non-motion conditions)
Update period 1s
Averaging time 7s
A.6.2 Masimo SpO
2
Specification
All SpO
2
sensors for Masimo SpO
2
Module specified in the section 10.1meets the following
specifications.
Item Specification
SpO
2
Measurement range 1 to 100%
Resolution 1%
Accuracy
70% to 100%:
70 %to 100%:
70 %to 100%:
0 %to 69%:
±2% (adult/pediatric, in non-motion conditions)
±3% (neonate, in non-motion conditions)
±3% (in motion conditions)
Undefined
Update period 1s
PR
Measurement range 25 to 240bpm
Resolution 1bpm
Accuracy
±3 bpm (in non-motion conditions)
±5 bpm (in motion conditions)
Update period 1s
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