Masimo Points To Note - GE CARESCAPE ONE User Manual

CARESCAPE ONE User Manual DRAFT 26 October 2017
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CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION

Masimo points to note

A functional tester cannot be used to assess the accuracy of the pulse oximetry
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device.
High-intensity extreme lights (such as pulsating strobe lights) directed on the
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sensor, may not allow the pulse oximetry device to obtain vital sign readings.
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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.
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 instrument
might read zero for the duration of the active irradiation
period.
The instrument must be configured to match your local power
line frequency to allow for the cancellation of noise introduced
by fluorescent lights and other sources.
To ensure that alarm limits are appropriate for the patient
being monitored, check the limits each time the pulse oximetry
device is used.
Variation in hemoglobin measurements may be profound
and may be affected by sampling technique 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 oximetry device 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 oximetry device.
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 instrument 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 oximetry device.
CARESCAPE ONE 2094480-001