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
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