Medivance Nasogastric Sump Tube with YSI Series 400 Temperature Sensor Medivance, Inc.

MRI Information

The Medivance Nasogastric Sump Tube with YSI Series 400 Temperature Sensor, 18-Fr. 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 Harbor Drive, PO Box C700, West Conshohocken, Pennsylvania, 2005.

Non-clinical testing demonstrated that the Medivance Nasogastric Sump Tube with YSI Series 400 Temperature Sensor, 18-Fr. is MR Conditional. A patient with this device can be scanned safely immediately after placement under the following conditions:

-Static magnetic field of 3-Tesla or less

-Spatial gradient magnetic field of 720-Gauss/cm or less

-Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 3-W/kg for 15 minutes of scanning.

In non-clinical testing, the Medivance Nasogastric Sump Tube with YSI Series 400 Temperature Sensor, 18-Fr. produced a temperature rise of 0.9°C at a maximum MR system-reported whole body averaged specific absorption rate (SAR) of 3-W/kg for 15-minutes of MR scanning in a 3-Tesla MR system using a transmit/receive body coil (Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI).

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Medivance Nasogastric Sump Tube with YSI Series 400 Temperature Sensor, 18-Fr. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

IMPORTANT NOTE: To ensure patient safety during MRI, the Medivance Nasogastric Sump Tube with YSI Series 400 Temperature Sensor, 18-Fr. must be labeled to verify that it is positioned exactly as it was for this MRI assessment: straight down the center of the patient, with the remaining tubing/connector going out the back of the MR system. The Medivance Nasogastric Sump Tube with YSI Series 400 Temperature Sensor, 18-Fr. should NOT be connected to a monitor and there should be NO loops or coils present. See additional information below:

(1) The Medivance Nasogastric Sump Tube with YSI Series 400 Temperature Sensor, 18-Fr. must disconnected from the monitor prior to the MRI procedure.

(2) Remove all electrically conductive material from the bore of the MR system that is not required for the procedure (i.e., unused surface coils, cables, etc.).

(3) Keep electrically conductive material that must remain in the bore of the MR system from directly contacting the patient by placing insulation or space between the conductive material and the patient.

(4) Position the Medivance Nasogastric Sump Tube with YSI Series 400 Temperature Sensor, 18-Fr. in a straight configuration to prevent cross points, coils, and loops. The remaining portion of this device, along with the connector should be positioned in a straight line out the BACK of the MR system (i.e., NOT along side the inside of the MR system).

(5) Ensure that the Medivance Nasogastric Sump Tube with YSI Series 400 Temperature Sensor, 18-Fr. exiting the patient does not touch the patient.

(6) Monitor the patient continuously using a verbal means (e.g., intercom). If the patient reports any unusual sensation, discontinue the MRI procedure immediately. Notably, MRI procedures should not be performed in patients that are unable to communicate (e.g., sedated, anesthetized, etc.).