1-16
System Overview
CDI Model CDI510H Optical InterfacCDI Model CDI510H Optical Interfacee
A transparent optical interface material found on
the back side of the CDI Model CDI510H Shunt
Sensors provides a consistent optical connection
between the sensor and the beroptic cable
connector. This material reduces the risk of
measurement errors caused by moisture
trapped between the microsensors and the
BPM. A thermal well on each sensor facilitates
the thermal transfer from the circuit to the
thermistor cap located on each BPM.
Each sensor contains a buffered calibration solution. This solution stabilizes the
microsensors during storage. It also reacts with the tonometered gases during
calibration to establish predictable pH, pO
2
and pCO
2
values.
Each CDI Shunt Sensor is intended for a single use. Aseptic technique must be used
when adding the CDI Shunt Sensor to the circuit. Luer caps and a sterile lter/sparger
assembly are provided on the sterile assemblies at each end of the Shunt Sensor to
protect the blood pathway from contamination prior to insertion into the circuit.
The CDI Shunt Sensor remains sterile so long as the package is unopened and
undamaged. Each Shunt Sensor is individually packaged in a foil pouch and has a
recommended shelf life indicated by the lot number expiration date printed on each
package. For additional information, refer to the Shunt Sensor instructions for use.
Warning
Products treated with heparin should not be used on patients
with heparin sensitivity.
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.
Store CDI Shunt Sensors between 0°C (32°F) and 35°C (94°F).
Freezing of the CDI Shunt Sensor, or storage at temperatures
outside the stated range, can result in inaccurate performance.
Do not reuse CDI Shunt Sensors. Used CDI Shunt Sensors are
contaminated and cannot be resterilized. Resterilization damages
the microsensors.
Shunt Sensors are sterile, heparin-coated, 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 measured parameters needed to
guide therapeutic decisions.
Optical
Interface
Thermal
Well
Optical
Interface