Welch Allyn 6000 Series Connex Vital Signs Monitor - User Manual User Manual

Page 206

Nellcor specifications (for additional information, refer to the directions for use that

accompanies each accessory)

Measurement range

20 to 250 beats per minute

Accuracy

±3 digits

Functional tester

WARNING Functional testers cannot be
used to assess the accuracy of a pulse
oximeter monitor.

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.

Masimo specifications (for additional information, refer to the directions for use that

accompanies each accessory)

SpO2

Unit of measure

Measurement range

0% to 100%

Masimo SpO2 sensor accuracy guide

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.

Accuracy

Note

Saturation accuracy varies by sensor type.
For additional sensor accuracy
information, refer to the DFU that
accompanies the sensor.

70% to 100%

Adults, Infants, Pediatrics (no motion

): ±2%

Neonates (no motion

): ±3%

Adults, Infants, Pediatrics, Neonates (motion

): ±3%

200 Specifications

Welch Allyn Connex

Vital Signs Monitor 6000 Series™