A - 11
A.6.2
PR
A.6.2.1
PR from Mindray SpO
2
Module
A.6.2.2
PR from Masimo SpO
2
Module
Black
Male
1
28.2±9.19
Healthy
Female
1
Yellow
Male
3
Female
9
Alarm limit
Range (bpm)
Step (bpm)
PR High
PR ≤ 40: (low limit +2) to 40
PR > 40: (low limit +5) to 300
PR ≤ 40: 1
PR > 40: 5
PR Low
PR ≤ 40: 15 to (high limit - 2)
PR > 40: 40 to (high limit - 5)
Measurement range
20 to 300 bpm
Resolution
1 bpm
Response time
< 30 s (normal perfusion, no disturbance, PR value
sudden change within 25 – 220 bpm)
Accuracy
±3 bpm
Refreshing rate
≤ 1 s
Measurement range
25 to 240 bpm
Resolution
1 bpm
Response time
≤ 20 s (normal perfusion, no disturbance, PR value
sudden change within 25 – 220 bpm)
Accuracy
±3 bpm (without motion)
±5 bpm (with motion)
Low perfusion conditions
Pulse amplitude: >0.02%
Light penetration: >5%
Low perfusion PR accuracy
1
±3 bpm
Refreshing rate
≤ 1 s
Summary of Contents for VS 8A
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