Mindray BeneVision N22 User Manual

A - 14 BeneVision N22/N19 Patient Monitor Operator’s Manual
A.14.3 SpO
2
Specifications
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 to (high limit - 2)
Nellcor: Desat or 20 (whichever is greater) to
(high limit - 2)
Desat 0 to (high limit - 2)
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 (SpO
2
value sudden changes from 70% to 100%)
<30 s (PR value sudden changes from 50 to 150 bpm)
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 ≤2 s
Averaging time 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 ≤2 s
Response time ≤30 s (PI > 0.3, no disturbance, SpO2 value sudden change from 70% to 100%)

Mindray BeneVision N22 Specifications

General

Brand	Mindray
Model	BeneVision N22
Category	Monitor
Language	English