ZOLL X Series, Руководство оператора

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Functional Testers and Patient Simulators
9650-001355-01 Rev. M X Series Operator’s Guide 10-17
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
2
measurements.
Fully evaluating the accuracy of the SpO
2
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, including known devices which claim to measure sensor LED
wavelength.
SpO
2
measurement accuracy can only be evaluated in vivo by comparing pulse oximeter
readings with values traceable to SpO
2
measurements obtained from simultaneously sampled
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
2
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.
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.