BeneVision N1 Patient Monitor Operator’s Manual
A - 13
A.14.3
SpO
2
Specifications
Refer to
F SpO2 Sensor Accuracy
for the clinical study results of SpO2 sensor accuracy.
Mindray SpO
2
Module
Nellcor SpO
2
Module
Alarm limit
Range (%)
Step (%)
SpO
2
High
(low limit + 2) to 100
1
SpO
2
Low
Mindray: (Desat+1) to (high limit - 2)
Nellcor: (Desat+1) or 20 (whichever is greater)
to (high limit - 2)
Desat
0 to (low limit - 1)
Standards
Meet standards of ISO 80601-2-61 2011
*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.
Measurement range
0 to 100%
Resolution
1%
Response time
< 30 s (normal perfusion, no disturbance, SpO
2
value sudden changes from
70% to 100%)
Accuracy
70 to 100%: ±2% (adult/pediatric)
70 to 100%: ±3% (neonate)
0% to 69%: Not specified.
* One percent was added to the accuracies for neonatal sensors to account for accuracy variation due to properties of fetal
hemoglobin. Studies were performed to validate the accuracy of Pulse Oximeter with neonatal SpO
2
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.
Sensor type
Totally neonates
Data
Arms
518B
97 (51 male & 46 female)
200 pairs
2.38%
520N
122 (65 male & 57 female)
200 pairs
2.88%
The Pulse Oximeter with neonatal SpO
2
sensors was also validated on adult subjects.
Refreshing rate
≤1 s
Sensitivity
High, Medium, Low
PI
Measurement range
0.05 to 20%
Resolution
PI<10.0: 0.01
PI≥10.0: 0.1
Measurement range
0 to 100%
Resolution
1%
Refreshing rate
≤1 s
Response time
≤30 s (normal perfusion, no disturbance, SpO
2
value sudden change from
70% to 100%)
