Welch Allyn Spot Vital Signs 4400, Service Manual

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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 device.
While functional testers may be useful for verifying that the pulse oximeter sensor, cabling, and
device 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
SpO2 performance measurement range 1 to 100%
Nonin sensor accuracy guide
SpO2 accuracy testing is conducted during
induced hypoxia studies on healthy, non-
smoking, light-to-dark-skinned subjects during
motion and no-motion conditions in an
independent research laboratory. The
measured arterial hemoglobin saturation value
(SpO2) of the sensors is compared to arterial
hemoglobin oxygen (SaO2) value, determined
from blood samples with a laboratory co-
oximeter. The accuracy of the sensors in
comparison to the co-oximeter samples
measured over the SpO2 range of 70 – 100%.
Accuracy data is calculated using the root-
mean-squared (A
rms
value) for all subjects, per
ISO 9919:2005, Standard Specification for Pulse
Oximeters for Accuracy.
Pulse rate
18 to 300 bpm: ± 3 digits
Low perfusion (40 to 240 bpm): ± 3 digits
Saturation
NOTE Saturation accuracy varies by sensor
type.
70% to 100%
Adult/Pediatrics
No Motion
Finger Clip: ± 2 digits
Flex: ± 3 digits
Motion
Finger Clip: ± 2 digits
Flex: ± 3 digits
90 Appendix