A - 12
A.6.2.3 PR from Nellcor SpO
2
Module
A.6.2.4 PR from N
IBP Module
A.6.3 NIBP
1
The Masimo pulse oximeter has been validated for low perfusion accuracy in bench top
testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of
greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70
to 100%. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
Measurement range 20 to 300 bpm
Resolution 1 bpm
Response time ≤30 s (normal perfusion, no disturbance, PR value
sudden change within 25 – 250 bpm)
Accuracy 20 to 250 bpm: ±3 bpm
251 to 300 bpm: not specified
Refreshing rate ≤ 1 s
Measurement range 30 to 300 bpm
Resolution 1 bpm
Accuracy ±3 bpm or ±3%, whichever is greater
Standards Meet standards of IEC 80601-2-30, ISO 81060-2
Technique Oscillometry
Mode of operation Manual, Auto, STAT, Sequence, and BP averaging
Auto mode repetition
intervals
1 min, 2 min, 2.5 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30
min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours
STAT mode cycle time 5 min
Typical measurement
time
Adult: ≤ 15 s (Inflation algorithm, measured with CM1203/
CM1303/CM1503 cuff, PR within 60 to 200 bpm and systolic
pressure within 80 to 120 mmHg)
Pediatric: ≤ 15 s (Inflation algorithm, measured with CM1202/
CM1302/CM1502 cuff, PR within 60 to 200 bpm and systolic
pressure within 80 to 120 mmHg)
Max measurement time Adult, pediatric: 180 s
Neonate: 90 s
Heart rate range 30 to 300bpm
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