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Magnetic Resonance (MR) imaging information
Non-clinical testing demonstrated that The aXess Hemodialysis Conduit is MR conditional. Follow the conditions provided below
MRI Safety Information
A patient implanted with an aXess Hemodialysis Conduit may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient. |
|
| Parameter | Condition of Use / Information |
| Static Magnetic Field Strength | 1.5 T, 3 T |
| Static Magnetic Field (B0) Orientation | Horizontal, Cylindrical Bore |
| Maximum Spatial Field Gradient (SFG) | 1.5 T: 79.82 T/m (= 7982 G/cm)
3 T: 39.91 T/m (= 3991 G/cm) |
| RF Polarization
(Note: formerly called RF Excitation) |
Circularly Polarized (CP) |
| RF Transmit Coil | Integrated Whole Body Transmit RF Coil |
| RF Receive Coil | Any receive RF coil may be used. |
| MR System (RF) Operating Modes or Constraints | Normal Operating Mode |
| Maximum Whole Body SAR | Whole Body Averaged SAR ≤ 2 W/kg
Note: Under the scan conditions defined above, the aXess Hemodialysis Conduit is expected to produce a maximum temperature rise in vivo of less than 6 °C at 1.5 T and at 3 T after 60 minutes of continuous scanning. |
| Scan Duration and Wait Time | Scanning for 1h max without a cooling period, then wait 15 minutes before resuming scanning.
Note: Autoscanning / Autoscan Mode is considered continuous scanning. Note: Short pauses between scan sequences are considered part of the scan time. |
| MR Image Artifact | The presence of the item within the MR image field of view may produce an image artifact. Some manipulation of scan parameters may be needed to compensate for the artifact. In non-clinical testing, the image artifact caused by the device extends approximately 6.2mm from the device edge when imaged with a spin echo pulse sequence and 5.4mm with a gradient echo, both at 1.5 T. |
