Masimo O3 Regional Oximeter, Руководство оператора, Страница: 13 / 52

O3® Regional Oximeter Safety Information, Warnings and Cautions
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CAUTION: Reset Baseline for each new patient monitored, if applicable.
CAUTION: rSO
2
readings represent a small volume of tissue beneath the O3 ® Sensor site and
may not reflect oxygenation elsewhere.
CAUTION:
High ambient light sources such as surgical lights (especially those with a xenon
light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight
can interfere with the performance of the sensor.
CAUTION: Replace the sensor when a Replace Sensor message is consistently displayed
while monitoring consecutive patients after completing the Replace Sensor troubleshooting
steps listed in the troubleshooting section.
CAUTION: Check the sensor site periodically for circulatory status. Each patient’s sensitivity
to the O3 ® sensors may vary depending on their medical status or condition of their skin.
Note: The value of rSO
2
data from the system has not been demonstrated in specific disease
states, under conditions of hemoglobinopathies or clinical conditions that may affect blood
volume, or under hypocapnic and hypercapnic conditions.
Note: The O3 ® system is intended for the monitoring of rSO
2
in the cerebral region under the
sensors. Other Body Sensor Sites selections are for reference only and are not intended for
patient monitoring.
Note:
The O3
®
Sensor duration of use is dependent on the condition of the sensor site and
patient’s skin integrity and sensor adhesion quality. The O3 ® Sensor has been
biocompatibility tested for the intended continuous use up to 72 hours.
Note:
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 patient monitoring time.
Cleaning and Service Warnings and Cautions
WARNING
: Do not use petroleum-based or acetone solutions, or other harsh solvents, to
clean the O3 ® Module. These substances affect the device’s materials and device failure can
result.
WARNING
: A functional tester cannot be used to assess the accuracy of the O3
®
Module.
CAUTION:
Do not submerge the O3
®
Module in any cleaning solution or attempt to sterilize
by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously
damage the O3 ® Module.
CAUTION
: An operator may only perform maintenance procedures specifically described in
the manual. Refer servicing to qualified service personnel trained in the repair of this
equipment.
Compliance Warnings and Cautions
WARNING
: Changes or modifications not expressly approved by Masimo shall void the
warranty for this equipment.
CAUTION : Disposal of product - Comply with local laws in the disposal of the device and/or
its accessories.
CAUTION
: For FCC compliance information, refer to the Operator's Manual for Root.