1-7
System Overview
Caution
Federal (U.S.A.) law restricts this device to sale, distribution and
use by or on the order of a physician.
Do not connect a Shunt Sensor to an unprimed circuit. Prolonged
“dry” exposure can damage the sensors.
Do not use chemical solvents such as alcohol, ether, and acetone
— or anesthetics such as Forane (isourane) — as cleaning agents
on any part of the system. These chemicals can be destructive to
the device. Follow the cleaning procedure in Chapter 7, “Routine
Cleaning,” using only the recommended cleaning agents.
Failure to follow the instructions can cause the monitoring system
to display inaccurate values.
The accuracy of the results is dependent upon the following:
Reading and understanding the instructions for use.
Proper set-up, full two point tonometered gas calibration, and
complete calibration of the potassium sensor and all other
parameters.
Use of all available system features.
Periodic comparison to a laboratory reference sample for blood
gas parameters.
Note: The hemoglobin measurement technique used in this instrument measures
total hemoglobin, and therefore includes other hemoglobin species such as carboxy-,
met-, sulf-, and fetal hemoglobin. Terumo Cardiovascular CDI blood parameter
monitoring systems are intended to monitor values including pH, pO
²
, pCO
²
, K
+
, SO
²
,
HCT and Hgb. When used in accordance with their instructions for use, the systems
have been demonstrated to provide reliable reports of these values with an accuracy
characterized in Appendix B.
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