Mindray Accutorr 7, Operator'S Manual

Page: 157 / 200

Accutorr 7 Operator’s Manual A - 7
Nellcor SpO
2
Module
Information of the Test Subjects of the Clinical Study Report
1
The Masimo pulse oximeter with sensors has been validated for no motion accuracy in
human blood studies on healthy adult volunteers in induced hypoxia studies in the range of
70% to 100% SpO
2
against a laboratory co-oximeter and ECG monitor. This variation equals
plus or minus one standard deviation. Plus or minus one standard deviation encompasses
68% of the population.
The Masimo pulse oximeter with sensors has been validated for motion accuracy in human
blood studies on healthy adult volunteers in induced hypoxia studies while performing
rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to 2 cm and non-repetitive
motion between 1 to 5 Hz. At an amplitude of 2 to 3 cm in induced hypoxia studies in the
range of 70% to 100% SpO
2
against a laboratory co-oximeter and ECG monitor. This
variation equals plus or minus one standard deviation. Plus or minus one standard deviation
encompasses 68% of the population.
2 The Masimo pulse oximeter has been validated for low perfusion accuracy in bench top
testing against a Biotek Index 2 simulator and Masimo’s simulator with signal strengths of
greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70
to 100%. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
Standards Meet standards of ISO 9919, ISO 80601-2-61
Measurement range 0 to 100%
Resolution 1%
Accuracy 70 to 100%: ±2% (adult/pediatric)
70 to 100%: ±3% (neonate)
0% to 69%: Not specified.
Refreshing rate 1 s
Response time ≤30 s (PI > 0.3, no disturbance, SpO
2
value sudden
change within 70% - 100%)
* 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.
Skin color Gender Number Age (years) Health
Black Male 1 28.2±9.19 Healthy
Female 1
Yellow Male 3
Female 9