A-8
A.7.3 SpO
2
Alarm limit Range (%) Step (%)
SpO
2
High (low limit + 2) to 100
1
SpO
2
Low
Mindray, Masimo: Desat to (high limit – 2)
Nellcor: Desat or 20 (whichever is greater) to (high limit – 2)
Desat 0 to (high limit – 2)
Mindray SpO
2
Module
Standards Meet standards of ISO9919
*Measurement accuracy verification: The SpO
2
accuracy has been verified in human experiments by comparing with arterial
blood sample reference measured with a CO-oximeter. Pulse oximeter measurement are statistically distributed and about
two-thirds of the measurements are expected to come within the specified accuracy range compared to CO-oximeter
measurements.
SpO
2
measurement range 0 to 100%
Resolution 1%
Accuracy
70 to 100%: ±3%
0% to 69%: Not specified.
Refreshing rate 1 s
PI measurement range 0.05% to 20%
Masimo SpO
2
Module
Standards Meet standards of ISO9919
SpO
2
measurement range 1 to 100%
Resolution 1%
Accuracy
70 to 100%: ±3% (measured without motion)
70 to 100%: ±3% (measured with motion)
1% to 69%: Not specified.
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 SpO
2
accuracy ±2%
PI measurement range 0.02~20 %
Nellcor SpO
2
Module
Standards Meet standards of ISO9919
Measurement range 0 to 100%
Resolution 1%
Accuracy
70 to 100%: ±3%
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.
To Next Page
Loading...