1-20
System Overview
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 (Cardio-Green) 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 deciency,
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.
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.
Caution
Do not use a CDI H/S Cuvette after the lot number expiration
date printed on the package label.
The CDI H/S Cuvette tubing connections should be secured with
tie-bands.
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