Operator's Manual

Chapter 14 Specifications and standards
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 236
SpO
2
was determined by testing on healthy adult volunteers in the range 60%-100% SpO2 against a
laboratory CO-Oximeter. SpO
2
accuracy was determined on 16 neonatal NICU patients ranging in age from
7 to 135 days old and weighting between 0.5 and 4.25 kg. Seventy-nine (79) data samples were collected
over a range of 70 - 100% SaO2 with a resultant accuracy of 2.9% SpO
2
.
The arterial oxygen saturation accuracy during no motion only applies to LNOP® Blue SpO
2
adhesive
sensors.
Masimo SET technology with LNOP Adt sensors has been validated for motion accuracy in human blood
studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia
studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-
repetitive motion between 1 to 4Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of
70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one
standard deviation which encompasses 68% of the population. The saturation accuracy of the neonatal
sensors was validated on adult male and female volunteers with light to dark skin pigmentation and 1% was
added to account for the properties of foetal haemoglobin.
The Masimo sensors have been validated for motion accuracy in human blood studies on healthy adult male
and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing
rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between
1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% 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.
Masimo SET technology 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 which encompasses 68% of the population.
Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top
testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which
encompasses 68% of the population.