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System Overview
How the System Works
The CDI OneView System is an AC-powered, microprocessor-based system. The system
uses an optical uorescence technology to measure blood gases, pH and potassium.
It additionally uses an optical reectance technology to measure oxygen saturation,
hematocrit and hemoglobin.
Optical uorescence measurements are taken through a Blood Parameter Module
(BPM) connected to a disposable Shunt Sensor. Optical reectance measurements
are taken through the Hematocrit/Saturation (H/S) Probe connected to a disposable
cuvette. Shunt Sensors and cuvettes are incorporated in the extracorporeal circuit.
Flow measurements are taken through a Flow Sensor attached to tubing on the
extracorporeal circuit.
Critical Operating Parameters and Warnings Prior to Operation Critical Operating Parameters and Warnings Prior to Operation
of the CDI OneView Monitoring Systemof the CDI OneView Monitoring System
Any user of the CDI OneView System must read and understand all the information
in this manual — the CDI OneView System Operator’s Manual — as well as the
instructions for use included with all associated disposables before using the system.
Special attention must be paid to the following crucial safety information:
Warning
The Shunt Sensor accessory contains Germall II in the calibration
uid. 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 (Cardio-Green), 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, point-of-care blood gas analyzer or independent ow
measurement) before initiating treatment.
Possible explosion hazard. Do not use the CDI OneView System in
the presence of ammable anesthetics or other explosive gases.
Do not use an apparently malfunctioning device in a procedure.