User's Manual Part 2

6-11
! CAUTION
• If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to
confirm the patient’s condition
• Never attach a SpO
2
sensor to a limb being monitored with a blood pressure cuff or a
limb with restricted blood flow.
• Because SpO
2
measurements depend upon light from a sensor, excessive ambient light
can interfere with the pulse oximeter’s measurements.
• Check application site frequently to assess circulation and positioning of the sensor on
the patient
• Change the application site or replace the sensor and/or patient cable when a “Bad
Probe”, or a persistent poor signal quality message (such as “Low Sig IQ”) is displayed
on the host monitor. These messages may indicate that patient monitoring time is
exhausted on the patient cable or sensor
• Replace the cable or sensor when a “Bad Probe” or when a “Low Sig IQ” message is
consistently displayed while monitoring consecutive patients after completing
troubleshooting steps listed in this manual
• 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
• When patients are undergoing photodynamic therapy they may be sensitive to light
sources. Pulse oximetry may be used only under careful clinical supervision for short
time periods to minimize interference with photodynamic therapy
• Do not place the pulse oximeter oPOD on electrical equipment that may affect the
device, preventing it from working properly
NOTE
• This pulse oximeter measures functional saturation, which is essentially the percentage
of hemoglobin that can transport oxygen (oxyhemoglobin). Pulse oximeters do not
detect significant amount of dysfunctional hemoglobins, such as carboxyhemoglobin or
methemoglobin, which cannot carry oxygen. Saturation measurements from pulse
oximeters cannot be directly compared to measurements from a laboratory co-oximeter.
• A pulse oximeter SpO
2
measurement may not match the saturation calculated from a
blood gas partial pressure of oxygen (PO
2
).
• Additional information specific to the iRadimed-Masimo approved sensors compatible
with the pulse oximeter, including information about parameter/measurement
performance during motion and low perfusion, may be found in Appendix D of these
directions for use (DFU)
6.2.1. Limitations
The following factors may influence the accuracy of measurement:
• Ambient Light
• Physical Movement (patient or imposed)
• Low Perfusion
• Dysfunctional hemoglobin, such as carboxyhemoglobin (COHb) and methemoglobin
(MetHb)
• Presence of certain intravascular dyes, such as methylene blue, indocyanine green and
indigo carmine
• Certain nail polishes
• Vasoconstrictive drugs, such as phenylephrine hydrochloride and dopamine, may affect
the accuracy of the measurement.
• Loose or Inappropriate positioning of the SpO
2
sensor