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| The ActiFlo Indwelling Bowel Catheter System was determined to be MR conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International Designation: F2503-05. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. ASTM International, 100 Barr Drive, PO Box C700, West Conshohocken, Pennsylvania, 2005: |
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| Non-clinical testing demonstrated that this product is MR Conditional according to the following conditions: |
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- Static magnetic field of 3-Tesla or less
- Highest spatial gradient magnetic field of 720-Gauss/cm or less
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| 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. |
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