A-12
Respiration Rate
Measurement range
Adult:
Pediatric, neonate:
0 to 120 rpm
0 to 150 rpm
Resolution 1 rpm
Accuracy
7 to 150 rpm:
0 to 6 rpm:
±2 rpm or ±2%, whichever is greater
Not specified.
Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s
Alarm limit Range (rpm) Step (rpm)
RR High (low limit + 2) to 100
RR Low 0 to (high limit – 2)
1
A.5.3 SpO
2
Alarm limit Range (%) Step (%) Delay (s)
SpO2 High (low limit + 1) to 100
SpO2 Low Desat to (high limit – 1)
Desat 50 to (high limit – 1)
1
10
Mindray SpO
2
Module
Standards Meet standards of ISO9919
*Measurement accuracy verification: The SpO2 accuracy has been verified in human
experiments by comparing with arterial blood sample reference measured with a CO-oximeter.
Pulse oximeter measurements are statistically distributed and about two-thirds of the
measurements are expected to come within the specified accuracy range compared to CO-oximeter
measurements.
Measurement range 0 to 100%
Resolution 1%
Accuracy
70 to 100%: ±2% (measured in adult/pediatric mode)
70 to 100%: ±3% (measured in neonate mode)
0% to 69%: Not specified.
*Studies were performed to validate the accuracy of Pulse Oximeter with neonatal SpO2 sensors
by contrast with a CO-Oximeter. Some neonates aged from 1 day to 30 days with a gestation age
of 22 weeks to full term were involved in this study. The statistical analysis of data of this study
shows the accuracy (Arms) is within the stated accuracy specification. Please see the following
table.
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