Sentec tcPCO2 - Specifications of Pulse Oximetry

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Specifications of tcPCO2 , tcPO2 and Pulse Oximetry
Specifications of Pulse Oximetry
Oxygen Saturation (SpO
2
)
Approved sites
for SpO
2
/PR monitoring
with SenTec TC sensors
Earlobe, low on forehead,
cheek, upper arm,
scapula (shoulder blade)
Measurement range 1 – 100%
Resolution 1%
Accuracy
(Arms over 70 to 100% range; all above specified sites)
• V-Sign™ Sensor 2 ± 2%
• OxiVenT™ Sensor ± 2.25%
Note: The SDMS measures functional oxygen saturation.
Note: SpO
2
accuracy specification is based on controlled
hypoxia studies on healthy, adult volunteers over the specified
saturation range by applying a defined sensor type to the
specified measurement sites. Pulse oximeter SpO
2
readings
were compared to SaO
2
values of blood samples measured
by hemoximetry. SpO
2
accuracy is expressed as Arms (root-
mean-square). The indicated variation equals plus or minus
one standard deviation (1SD), which encompasses 68% of the
population.
Note: A functional tester cannot be used to assess the SpO
2
accuracy.
Pulse Rate (PR)
Measurement range 30 – 250 bpm (beats per minute)
Resolution 1 bpm
Accuracy ± 3 bpm
Note: PR accuracy was determined using a Pulse Oximeter
Simulator (optical simulator for bench tests).
Note: A functional tester cannot be used to assess the PR
accuracy.