Welch Allyn Connex Integrated Wall System - User Manual - Manual (Page 117)

SpO2 specifications (refer to sensor manufacturer's directions for use for
additional information)
Functional tester
WARNING A functional tester
cannot be used to assess the
accuracy of a pulse oximeter monitor.
1
1 Some models of commercially available bench top functional testers and patient simulators can be used to
verify the proper functionality of Nellcor pulse oximeter sensors, cables and monitors. See the individual
testing device's operator's manual for the procedures specific to the model of tester being used.
While such devices 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.
Many functional testers and patient simulators have been designed to interface with the pulse oximeter's
expected calibration curves and may be suitable for use with Nellcor monitors and/or sensors. Not all such
devices, however, are adapted for use with the Nellcor OXIMAX digital calibration system. While this will not
affect use of the simulator for verifying system functionality, displayed SpO2 measurement values may differ
from the setting of the test device. For a properly functioning monitor, this difference will be reproducible over
time and from monitor to monitor within the performance specifications of the test device.
SpHb specifications (refer to sensor manufacturer's directions for use for
additional information)
SpHb saturation range 0 to 25 g/dL
Masimo SpHb sensor accuracy guide Adults, Pediatrics (no motion): 8 to 17 g/dL ± 1 g/dL.
SpHb accuracy has been validated on healthy adult
male and female volunteers and on surgical patients
with light to dark skin pigmentation in the range of 8 to
17 g/dL SpHb against a laboratory co-oximeter. This
variation equals ± 1 standard deviation which
encompasses 68% of the population. The SpHb
accuracy has not been validated with motion or low
perfusion.
Environmental specifications
Operating temperature 50°F to 104°F (10°C to 40°C)
Storage temperature -4°F to 122°F (-20°C to 50°C)
Operating altitude -557 to 10,000 ft. (-170 m to 3,048 m)
Operating humidity 15 to 95% noncondensing
Storage humidity 15% to 95% noncondensing
Directions for use Specifications 111