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	ActiFlo Indwelling Bowel Catheter System ActiFlo Indwelling Bowel Catheter System The ActiFlo Indwelling Bowel Catheter System (also known as Zassi Bowel Management System (Hollister, Libertyville, IL) is intended for diversion of fecal matter to minimize external contact with the patient's skin, to facilitate the collection of fecal matter for patients requiring stool management, to provide access for colonic irrigation and to administer enema/medications. This system consists of three main parts: the catheter, the collection bag, and the irrigation bag. The insertion end of the catheter contains a retention cuff and an intraluminal balloon, each with its own Luer connector used for inflation and deflation. A third connector provides a way to administer medications into the rectum and provides access for colonic irrigation. The ActiFlo Indwelling Bowel Catheter System allows stool to drain directly from the rectum into a closed or drainable collection bag. MRI Information The following product was determined to be MR conditional according to the terminology specified in the ASTM International, Designation: F2503-05. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment: ActiFlo Indwelling Bowel Catheter System Non-clinical testing demonstrated that this product is MR Conditional according to the following conditions: -Static magnetic field of 3-Tesla or less -Highest spatial gradient magnetic field of 720-Gauss/cm or less Important note: The metallic spring is located outside of the patient's body during the intended in vivo use of this product. Therefore, the only possible MRI-related issue pertains to magnetic field interactions. Heating and artifacts are of no concern. As such, the assessment of magnetic field interactions for this product specifically involved evaluations of translational attraction and torque in relation to exposure to a 3-Tesla MR system, only. Evaluations of MRI-related heating and artifacts were not conducted and are unnecessary REFERENCE http://www.hollister.co.za/us/

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ActiFlo Indwelling Bowel Catheter System