A - 14 BeneVision N Series Patient Monitor Operator’s Manual
A.15.3 SpO
2
Specifications
Mindray SpO
2
Module
Resolution 1 rpm
Accuracy 0 to 120 rpm: ±1 rpm
121 to 200 rpm: ±2 rpm
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 Adult, pediatric:
RR≤20
RR>20
Neonate:
RR≤20
RR>20
(low limit + 2) to 20
(low limit + 5) to 100
(low limit + 2) to 20
(low limit + 5) to 150
RR≤20: 1
RR>20: 5
RR Low RR≤20:
RR>20:
0 to (high limit - 2)
20 to (high limit - 5)
Alarm limit Range (%) Step (%)
SpO
2
High (low limit + 2) to 100 1
SpO
2
Low Mindray/Masimo: (Desat+1) to (high limit - 2)
Nellcor: (Desat+1) or 20 (whichever is greater)
to (high limit - 2)
SpO
2
Desat Low 0 to (high limit - 2)
SpO
2
High 0 to 50
Standards Meet standards of ISO 80601-2-61
*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 mode)
70 to 100%: ±3% (neonate mode)
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
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