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                                            Safety Information Article
                      Information on this page is limited by the terms of our Disclaimer.  Please Read!

       Alsius Intravascular Temperature Management 

Alsius Corporation (a Zoll Corporation, Chelmsford, MA) products are designed for placement in the central venous system. Via a proprietary, “closed loop” internal cooling circuit, the catheter cools or warms the patient’s blood as it circulates past the catheter. The catheters (Cool Line, Icy, and Fortius) are attached to the CoolGard 3000 Thermal Regulation System. This is an electronic cooling system that regulates the cooling performance of the catheter via remote sensing of the patient’s temperature. Alsius catheters are also designed to facilitate critical care management with features similar to those found in conventional central venous catheters.

CoolGard 3000. All Alsius heat exchange catheters connect to the CoolGard 3000 Thermal Regulation System, which achieves and maintains a target temperature input by the user. It remotely senses changes in patient core temperature and automatically adjusts the temperature of the circulating saline within the catheter (0 to 42 degrees C), providing consistent maintenance of temperature.

Cool Line Catheter. The Cool Line Catheter is inserted into the subclavian or jugular vein and resides in the superior vena cava. The Cool Line Catheter combines temperature control and central venous catheter capabilities.

Icy Catheter. The Icy catheter is inserted into the femoral vein and resides in the inferior vena cava.

Fortius Catheter. The Fortius catheter is inserted percutaneously into the femoral vein residing in the inferior vena cava, just below the heart. The Fortius catheter provides maximum heat exchange power with minimum time to target temperature.

MRI Information

The following models of Alsius Heat Exchange catheters have been determined to be MR Safe:

-Cool Line
-Icy
-Fortius

Magnetic resonance imaging (MRI) procedures must be performed according to the following guidelines:

Through non-clinical testing, these catheters were shown to be MR Safe* at a field strength of 1.5 Tesla or less and a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI. MRI at 1.5-Tesla (highest spatial gradient magnetic field, 2.4 Tesla/meter) or less may be performed immediately following the insertion of the one of these catheters.

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of these catheters. Therefore, it may be necessary to optimize the MRI parameters for the presence of these metallic devices.

IMPORTANT NOTE: The Alsius CoolGard 3000 system is not MRI Safe nor Compatible nor intended for use in an MRI environment. The Catheter should be disconnected from the System prior to moving the patient to the MRI facility.

[*Note the use of the term “MR Safe”. These products underwent testing and labeling prior to the implementation of the current terminology. For further explanation, please refer to Terminology for Implants and Devices.]

REFERENCES
www.alsius.com

www.zoll.com



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