ActiFlo Indwelling Bowel Catheter System

The ActiFlo Indwelling Bowel Catheter System (also known as the 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 or medications. This system consists the catheter, the collection bag, and the irrigation bag. The ActiFlo Indwelling Bowel Catheter System allows stool to drain directly from the rectum into a closed or drainable collection bag.

MRI Information

The ActiFlo Indwelling Bowel Catheter System was determined to be MR Conditional:

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

Important note: A metallic spring used for this device 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. Therefore, 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.

REFERENCE

www.hollister.co.za/us/