The pulse oximeter device is calibrated to display functional blood oxygen saturation.
Validation of the accuracy of SpO
2
measurement: The accuracy of Masimo SpO
2
has been validated in
comparison with the reference value of arterial blood samples measured by CO-oxygen manometers in
clinical investigation. The pulsation oximeter measurement results conform to the statistical
distribution. Compared with the CO-oximeter measurement results, it is expected that about two-thirds
of the measurement results will fall within the specified accuracy range.
Masimo SpO
2
has induced a hypoxic state in human blood with a SpO
2
of 70% to 100% in healthy adult
volunteers. By comparing with the laboratory combined photoelectric oximeter and high flow
respiratory humidification therapy device, validated the accuracy under no motion. This variation equals
plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68%of the
population weight.
Masimo SpO
2
has been validated for motion accuracy in human blood studies on healthy adult male and
female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing
rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion
between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO
2
against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard
deviation. Plus or minus one standard deviation encompasses 68% of the population
11.2.1 Masimo SpO2 Specific Information
If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In the
interim, assess the patient and, if indicated, verify oxygenation status through other means.
Change the application site or replace the sensor and/or patient cable when a “Replace sensor” and/or
“Replace patient cable”, or a persistent poor signal quality message (such as “Low SIQ”) is displayed
on the host monitor. These messages may indicate that the monitoring cables are beyond their service
life and should be replaced.
Replace the cable or sensor when a replace sensor or when a low SIQ message is consistently displayed
while monitoring consecutive patients after completing troubleshooting steps listed in this manual.
When using the Maximum Sensitivity setting, performance of the "Sensor Off" detection may be
compromised. If the device is in this setting and the sensor becomes dislodged from the patient, the
potential for false readings may occur due to environmental "noise" such as light, vibration, and
excessive air movement.
Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage the
patient cabling.
Additional information specific to the Masimo sensors compatible with the pulse oximeter, including
information about parameter/measurement performance during motion and low perfusion, may be
found in the sensor's directions for use (DFU).
Cables and sensors are provided with X-Cal™ technology to minimize the risk of inaccurate readings and
unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for the specified duration of
the patient monitoring time.
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