Welch Allyn Connex Spot Monitor Directions For Use Manual page 143

Directions for use
SpO2 specifications (Masimo specifications, see footnotes 1, 2, 3, 4, 5, and 6)
1
SpO2, accuracy was determined by testing on healthy adult volunteers in the range of
60-100% SpO2 against a laboratory pulse oximeter. SpO2 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
with a resultant accuracy of 2.9% SpO2.
2
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 pulse
oximeter and ECG monitor. This variation equals plus or minus one standard deviation.
Plus or minus one standard deviation encompasses 68% of the population.
3
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 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.
4
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 0.02% and transmission of greater than 5% for saturations
ranging from 70–100%. This variation equals plus or minus one standard deviation which
encompasses 68% of the population.
5
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.
6
The following substances may interfere with pulse oximetry measurements:
• Elevated levels of Methemoglobin (MetHb) may lead to inaccurate SpO2
measurements
• Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2
measurements
• Severe anemia may cause erroneous SpO2 readings
• Dyes, or any substance containing dyes, that change usual blood pigmentation may
cause erroneous readings
• Elevated levels of total bilirubin may lead to inaccurate SpO2 reading
Specifications 137
Finger Clip: ± 2 digits Flex: ± 3 digits
Flex: ± 3 digits Soft Sensor: N/A
Soft Sensor: ± 2 digits 8000R: N/A
8000R: ± 3 digits 8000 Q: N/A
8000 Q: ± 4digits Motion
Motion
Finger Clip: ± 3 digits
Finger Clip: ± 2 digits Flex: ± 4 digits
Flex: ± 3 digits Soft Sensor: ± 4 digits
Soft Sensor: ± 3 digits Low Perfusion
Low Perfusion All Sensors: ± 3 digits
All Sensors: ± 2 digits