Product Manual

SpO2 specifications
Refer to sensor manufacturer's directions for use for additional information.
WARNING Functional testers cannot be used to assess the accuracy of a
pulse oximeter monitor.
While functional testers may be useful for verifying that the pulse oximeter sensor,
cabling, and monitor are functional, they are incapable of providing the data required to
properly evaluate the accuracy of a system's SpO2 measurements. Fully evaluating the
accuracy of the SpO2 measurements requires, at a minimum, accommodating the
wavelength characteristics of the sensor and reproducing the complex optical interaction
of the sensor and the patient’s tissue. These capabilities are beyond the scope of known
bench-top testers. SpO2 measurement accuracy can only be evaluated in vivo by
comparing pulse oximeter readings with SaO2 measurements obtained from
simultaneously sampled arterial blood made using a laboratory CO-oximeter.
Note Contact the sensor manufacturer for further SpO2 clinical testing
information.
Note Refer to sensor manufacturers' directions for use for further accuracy
information.
SpO2 specifications (Masimo specifications, see footnotes 1, 2, 3, 4, 5, and 6)
SpO2 performance measurement range 1 to 100%
Masimo SpO2 specifications
Accuracy specified when used with Masimo SET
pulse oximetry monitors or with licensed Masimo
SET pulse oximetry modules using PC series patient
cables, during no motion. Numbers present ± 1
standard deviation. Plus or minus one standard
deviation represents 68% of the population.
Masimo SpO
2
, No Motion 60 – 80 ± 3%, adults/pediatrics/infants
70 – 100 ± 2%, adults/pediatrics/infants; ± 3%,
neonates
Masimo SpO
2
, Motion 70 – 100 ± 3%, adults/pediatrics/infants/neonates
Masimo SpO
2
, Low perfusion 70 – 100 ± 2%, adults/pediatrics/infants/neonates
Perfusion 0.02 % to 20 %
Masimo pulse rate , No Motion 25 – 240 ± 3 bpm, adults/pediatrics/infants/
neonates
Masimo pulse rate, Motion 25 – 240 ± 5 bpm, adults/pediatrics/infants/
neonates
Masimo pulse rate, Low perfusion 25 – 240 ± 3 bpm, adults/pediatrics/infants/
neonates
Pulse rate 25 to 240 beats per minute (bpm)
Directions for use Specifications 131