Functional Testers And Patient Simulators; Patents - ZOLL X Series Operator's Manual

Functional Testers and Patient Simulators

Some models of commercially available bench top functional testers and patient simulators can
be used to verify the proper functionality of Masimo pulse oximeter sensors, cables and
monitors. See the individual testing device's operator's manual for the procedures specific to the
model of tester that you are using.
While such devices may be useful for verifying that the pulse oximeter sensor, cable, and
monitor are functional, they are incapable of providing the data required to properly evaluate
the accuracy of a system's SpO
Fully evaluating the accuracy of the SpO
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, including known devices which claim to measure sensor LED
wavelength.
SpO measurement accuracy can only be evaluated in vivo by comparing pulse oximeter
2
readings with values traceable to SpO
arterial blood 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 Masimo monitors and/
or sensors. Not all such devices, however, are adapted for use with the Masimo digital
calibration system. While this will not affect use of the simulator for verifying system
functionality, displayed SpO
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.

Patents

All patent information related to the SpO2 component of the X Series unit can be found at the
following:
www.masimo.com/patents.htm
NO IMPLIED LICENSE
Possession or purchase of this device does not convey any express or implied license to use the
device with unauthorized sensors or cables which would, alone or in combination with this
device, fall within the scope of one or more of the patents relating to this device.
9650-001355-01 Rev. M
measurements.
2
measurements requires, at a minimum,
2
measurements obtained from simultaneously sampled
2
measurement values may differ from the setting of the test
2
X Series Operator's Guide
Functional Testers and Patient Simulators
10-17