A-7
0% to 69%: Not specified.
Refreshing rate 1 s
Response time
≤ 30 s (PI > 0.3, no disturbance, SpO2 value sudden change
within 70% - 100%)
* When the SpO
2
sensor is applied for neonatal patients as indicated, the specified accuracy
range is increased by ±1%, to compensate for the theoretical effect on oximeter
measurements of fetal hemoglobin in neonatal blood.
Information of the Test Subjects of the Clinical Study Report
Skin color Gender Number Age (years) Health
Black Male 1 28.2±9.19 Healthy
Female 1
Yellow Male 3
Female 9
A.6.2 PR
Module PR High Limit PR Low Limit Step (bpm)
Mindray SpO
2
Module (low limit +2) to 254 20 to (high limit-2)
1
Masimo SpO
2
Module (low limit +2) to 240 25 to (high limit-2)
Nellcor SpO
2
Module (low limit +2) to 300 20 to (high limit-2)
NIBP Module (low limit +2) to 240 40 to (high limit-2)
PR from Mindray SpO
2
Module
Measurement range 20 to 254 bpm
Resolution 1 bpm
Response time
≤ 30 s (PI > 0.3, no disturbance, PR value sudden change within
25 --- 250 bpm)
Accuracy ±3 bpm (without motion)
Refreshing rate 1 s
PR from Masimo SpO
2
Module
Measurement range 25 to 240 bpm
Resolution 1 bpm
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