Passport 12/Passport 8 Operator’s Manual A-11
Nellcor SpO
2
Module
Standards Meet standards of ISO9919
Measurement range 0 to 100%
Resolution 1%
Accuracy
70 to 100%: ±2% (adult/pediatric)
70 to 100%: ±3% (neonate)
0% to 69%: Not specified.
*: 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.7.4 PR
Alarm limit Range (bpm) Step (bpm)
PR High (low limit +2) to 300
1
PR Low 15 to (high limit-2)
PR from Masimo SpO
2
Module
Measurement range 25 to 240 bpm
Resolution 1 bpm
Accuracy
±3 bpm (measured without motion)
±5 bpm (measured with motion)
Refreshing rate 1 s
SPO
2
averaging time 2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s
Low perfusion conditions
Pulse amplitude: >0.02%
Light penetration: >5%
Low perfusion PR accuracy ±3 bpm
PR from Nellcor SpO
2
Module
Measurement range 20 to 300 bpm
Resolution 1 bpm
Accuracy
20 to 250 bpm: ±3 bpm
251 to 300 bpm, not specified
Refreshing rate 1 s
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