Terumo CDI 550, Operator'S Manual

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introduction chapter 1 1-4
Optical reflectance measurement.
The monitor’s optical probe sensing surface
contains light emitting diodes (LEDs) and a photodetector. The LEDs direct light
pulses at the blood through an optical window in the Terumo CDI H/S Cuvette, which
is inserted into the extracorporeal circuit. The intensity of the resulting reflections are
analyzed (on the basis of the characteristic spectra of the oxy- and deoxy- forms of
hemoglobin) to determine the oxygen saturation, hematocrit, and hemoglobin. These
values are displayed on the monitor’s screen.
Before you begin
You must read and understand all the information in this manual — the CDI Blood
Parameter Monitoring System 550 Operator’s Manual — and the instructions for use
that came with associated disposables before using the system. Pay special attention
to the following important safety information:
• The shunt sensor accessory contains Germall II in the calibration fluid.
A potential byproduct of Germall II may be Formaldehyde. Exposure
may cause adverse reactions in patients with Formaldehyde sensitivity.
• The shunt sensor is heparin treated and should not be used with
heparin sensitive patients. Devices with heparin treated surfaces may
cause an adverse reaction.
• Use of the following substances can potentially cause inaccuracies in
displayed values: Indocyanine green (Cardiogreen), Methylene Blue,
or other intravascular dyes, carboxyhemoglobin or situations such as
dyshemoglobins, hemoglobinopathies, elevated bilirubinemia and/or
icterus (jaundice).
• Verify the accuracy of displayed values with another source (i.e.
laboratory or point of care blood gas analyzer) before initiating
treatment.
Warning
• Possible explosion hazard. Do not use the CDI System 550 Monitor in
the presence of flammable anesthetics or other explosive gases.
• Do not use an apparently malfunctioning device in an operation.
• Computer equipment in the operating room environment may interfere
with the operation of existing monitoring or therapeutic devices, and
may be susceptible to interference from such devices. To ensure that
such interference will not occur, care must be taken in the selection of
computer equipment or printers to be interfaced with the CDI System
550 Monitor and in the manner in which this interface is accomplished.
• Maintain adequate levels of anticoagulation during extracorporeal
circulation by monitoring activated clotting time (ACT) or another
appropriate measurement. Use of a heparin treated device does not
substitute for adequate anticoagulation levels.