1-6
System Overview
Independent external blood gas and blood chemistry analysis is
required for accurate determination of all measured parameters
needed to guide therapeutic decisions whenever intravascular
dyes are administered or when dyshemoglobins or elevated
bilirubin levels are present.
Use caution when administering novel pharmacological agents
when the user is unfamiliar with the potential effect of such
agents on the CDI sensors.
Do not attempt in vivo recalibration expecting to re-align
values affected by interference due to intravascular dyes or
pharmacological agents; the interference may be prolonged
resulting in continuing inaccuracies.
Exposure of the Shunt Sensor to prime solutions and/or blood
with pH less than 7.0 or greater than 7.8 pH units can interfere in
the accurate measurement of potassium.
Exposure of the Shunt Sensor to prime solutions and/or blood
with sodium measurement less than 120 or greater than 160
mEq/L can interfere in the accurate measurement of potassium.
Failure to perform a proper setup including a full two-point
tonometered gas calibration and a complete calibration of the
potassium sensor, including in vivo recalibration, may inhibit the
system from achieving accuracy limits found in Appendix B.
Measured values prior to initial in vivo recalibration may not be
accurate. Do not use values prior to initial in vivo recalibration for
patient management. At the beginning of a case after the initiation
of cardiopulmonary bypass and when conditions are stable,
the user must complete recalibration of all measurable blood
parameters by comparing them to a laboratory measurement
done on a blood sample. The values are greyed out and not bold
on the CDI OneView System screen to indicate the values are not
accurate until an initial in vivo recalibration has been performed.
After an in vivo recalibration is performed, the values become
bold.
After changes of blood temperature of > 6°C, the user must repeat
an in vivo recalibration of Shunt Sensor values once temperature
stability has been achieved. Optimal system accuracy will be
maintained by this practice.
The temperature measured by the Shunt Sensor is local to the
sensor and does not reect the actual patient arterial or venous
blood temperature. Do not use this measurement for patient
management.
To avoid risk of electrical shock and to achieve grounding
reliability, the Core must only be connected to a supply mains
with protective earth ground.
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