Welch Allyn Connex Spot Monitor Directions For Use Manual page 141

Directions for use
SpO2 specifications
Refer to sensor manufacturer's directions for use for additional information.
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
Note
SpO2 specifications (Masimo specifications, see footnotes 1, 2, 3, 4, 5, and 6)
SpO2 performance measurement range
Masimo SpO2 specifications
Masimo SpO
Masimo SpO
Masimo SpO
Perfusion
Masimo pulse rate , No Motion
Masimo pulse rate, Motion
Masimo pulse rate, Low perfusion
Pulse rate
WARNING Functional testers cannot be used to assess the accuracy of a
pulse oximeter monitor.
Contact the sensor manufacturer for further SpO2 clinical testing
information.
Refer to sensor manufacturers' directions for use for further accuracy
information.
, No Motion
2
, Motion
2
, Low perfusion
2
Specifications 135
1 to 100%
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.
60 – 80 ± 3%, adults/pediatrics/infants
70 – 100 ± 2%, adults/pediatrics/infants; ± 3%,
neonates
70 – 100 ± 3%, adults/pediatrics/infants/neonates
70 – 100 ± 2%, adults/pediatrics/infants/neonates
0.02 % to 20 %
25 – 240 ± 3 bpm, adults/pediatrics/infants/
neonates
25 – 240 ± 5 bpm, adults/pediatrics/infants/
neonates
25 – 240 ± 3 bpm, adults/pediatrics/infants/
neonates
25 to 240 beats per minute (bpm)