Terumo CDI 550, Operator'S Manual

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introduction chapter 1 1-16
Note: When the CDI H/S Cuvette is inserted into the circuit, the optical window
should be pointing down. This minimizes interference from intermittent air bubbles in
the line.
5170116
Optical Window
Magnets
Aseptic technique must be used when adding the CDI H/S Cuvette to the circuit. End
caps are provided on the sterile assemblies at each end of the cuvette to protect the
blood pathway from contamination prior to insertion into the circuit. The CDI H/S
Cuvette remains sterile as long as the package is unopened and undamaged. Each
CDI H/S Cuvette has a recommended shelf life indicated by the lot number expiration
date printed on each package. For additional information, refer to the CDI H/S Cuvette
instructions for use.
Warning
• Maintain adequate levels of anticoagulation during extracorporeal
circulation by monitoring activated clotting time (ACT) or another
appropriate measurement.
• Do not attempt to re-sterilize the CDI H/S Cuvette. Improper
sterilization can reduce system accuracy or cause the CDI H/S Cuvette
to leak under pressure.
• Do not reuse CDI H/S Cuvettes. CDI H/S Cuvettes are intended for a
single use only.
• The H/S cuvettes are sterile, non-toxic, non-pyrogenic, single use
devices and for use in cardiopulmonary bypass procedures for up to 6
hours.
• Use of certain intravascular dyes during cardiovascular surgery such
as Indocyanine green (Cardiogreen) and Methylene Blue may cause
inaccuracies in displayed values. Independent external blood gas and
blood chemistry analysis is required for accurate determination of all
measure parameters needed to guide therapeutic decisions.
• Elevated levels of blood substances including irregular cell
morphologies, protein levels, plasma free hemoglobin and bilirubin
may interfere with blood measurements. Independent external
blood gas and blood chemistry analysis is required for accurate
determination of all measured parameters needed to guide therapeutic
decisions.
• Blood conditions such as hemoglobinopathies, thalassemia and a
variety of anemic conditions (sickle cell, iron deficiency, macrocytic),
may affect the accuracy of hemoglobin and hematocrit measurements.
Independent external analysis is required for accurate determination of
these measurements as needed to guide therapeutic decisions.