Operator's Manual

14.1 Specifications
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 237
14.1.8 Masimo Set rainbow
Carboxyhemoglobin (SpCO)
Measurement Range: 0 – 99%
Accuracy (Adults/Paediatrics/Infants): 1 – 40% ± 3%
Resolution: 1%
Alarm: 1-98%
Methaemoglobin saturation (SpMet)
Measurement Range: 0 – 99.9%
Accuracy
(Adults/Paediatrics/Infants/Neonates):
1 – 15% ± 1%
Resolution: 0.1%
Alarm: 1-99.5%
Total haemoglobin concentration (SpHb)
Measurement Range: 0 – 25 g/dL
Accuracy (Adults/Paediatrics): 8 – 17 g/dL ±1 g/dL (arterial or venous)
Resolution: 0.1 g/dL
Alarm: 1-24.5 g/dL
Total oxygen content (SpOC)
Measurement Range: 0 – 35ml of O2/dL of blood
SpO2, SpCO, and SpMet accuracy was determined by testing on healthy adult volunteers in the range of
60% - 100% SpO2, O% - 40% SpCO, and 0% - 15% SpMet against a laboratory CO-Oximeter. SpO2 and
SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7-135 days old and
weighing between 0.5-4.25 kg. Seventy-nine (79) data samples were collected over a range of 70-100%
SaO2 and 0.5-2.5% MetHb with a resultant accuracy of 2.9% SpO2 and 0.9% SpMet.
The Masimo sensors have been validated for no motion accuracy in human blood studies on healthy adult
male and female volunteers with light to dark skin pigmentation 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. Plus or minus one standard deviation encompasses 68% of the population.
The 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 0.2% and 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.
The 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.
SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients
with light to dark skin pigmentation in the range of 8-17 g/dl SpHb against a laboratory CO-oximeter. This
variation equals plus or minus one standard deviation which encompasses 68% of the population. The
SpHb accuracy has not been validated with motion or low perfusion.
The following substances may interfere with pulse CO-Oximetry measurements:
 Elevated levels of Methaemoglobin (MetHb) may lead to inaccurate SpO2 and SpCO measurements
 Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2 measurements
 Very low arterial Oxygen Saturation (SpO2) levels may cause inaccurate SpCO and SpMet
measurements
 Severe anaemia may cause erroneous SpO2 readings