Electrical shock and flammability hazard: Before cleaning, always turn off the device and disconnect
from any power source.
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 on electrical equipment that may affect the device, preventing it from
working properly.
If SpO
2
values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patient’s
condition.
If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If the
sensor is exposed to the radiation, the reading might be inaccurate or the device might read zero for
the duration of the irradiation period.
Ensure that alarm limits of SpO
2
and PR are appropriate for the patient being monitored.
Variation in measurements may be significant and may be affected by sampling techniques as well as
the patient's physiological conditions. Any results exhibiting inconsistency with the patient’s clinical
status should be repeated and/or supplemented with additional test data. Blood samples should be
analyzed by laboratory instruments prior to clinical decision making to completely understand the
patient’s condition.
Do not submerge the pulse oximeter in any cleaning solution or attempt to sterilize by autoclave,
irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the pulse
oximeter.
Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-applied
circuits and the system are within acceptable limits as specified by the applicable safety standards. The
summation of leakage currents must be checked and in compliance with IEC 60601-1 and UL60601-1.
The system leakage current must be checked when connecting external equipment to the system.
When an event such as a component drop of approximately 1 meter or greater or a spillage of blood
or other liquids occurs, retest before further use. Injury to personnel could occur.
Disposal of product - Comply with local laws in the disposal of the device and/or its accessories.
To minimize radio interference, other electrical equipment that emits radio frequency transmissions
should not be in close proximity to the pulse oximeter.
A functional tester cannot be used to assess the accuracy of the pulse oximeter.
High-intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not allow the
pulse oximeter to obtain vital sign readings.
Make sure your nails block the light inside the probe. The probe cable should be placed on the back of
the hand.
Do not place the SpO
2
sensor and NIBP cuff on the same limb, because blood flow occlusion during NIBP
measurement will affect the functional oxygen saturation reading.
The displayed SpO
2
waveform is normalized.
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