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MRI Safety Information

Non-clinical testing has demonstrated the TRACOE silcosoft tracheostomy tube is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

  • Static magnetic field of 1.5 Tesla (T) or 3.0 Tesla (T).
  • Maximum spatial field gradient of 1900 gauss/cm (19 T/m)
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (normal operating mode).
  • The neck flange must be secured in place with the neck strap.
  • For tubes with H2O Cuff only: The check valve must be secured to the skin with medical tape, away from the area of MR diagnostic interest.


In non-clinical testing, the image artifact caused by the tube extends (radially) up to 19 mm from the TRACOE silcosoft tracheostomy tube (non-cuffed) when imaged with a gradient echo pulse sequence and a 1.5 T MR system, and up to 28 mm when imaged with a spin echo pulse sequence in a 3.0 T MR system.

Tubes with H2O Cuff: In non-clinical testing, the image artefact caused by the check valve extends (radially) up to 107 mm from the check valve when imaged with a gradient echo pulse sequence and a 1.5 T MR system, and up to 113 mm when imaged with a spin echo pulse sequence in a 3.0 T MR system. Therefore, when MR imaging the tube with H2O Cuff, it is recommended to tape the check valve to the patient’s skin away from the area of interest.

Warning

When used in MR Imaging:

  • Securely fasten the tube, with the neck strap, to prevent possible movement while in the MR environment.
  • Securely affix the check valve away from the area of interest with standard medical tape to prevent movement while in the MR environment.
  • MR image quality may be compromised if the area of interest is close to the position of the tube and/or inflation valve