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•
Prior to tube insertion, check that the obturator can be inserted and
removed without difficulty.
Use During MRI
Non-clinical testing has demonstrated that the device is MR Conditional.
This device includes a luer valve that contains a metal spring that is
external to the patient. A patient with this device can be safely scanned
in a MR system meeting the following conditions:
•
Static magnetic field of 1.5 T or 3.0T,
•
maximum spatial field gradient of 1,900 gauss/cm (19T/m)
•
maximum MR system reported whole body averaged specific
absorption rate (SAR) of 4 W/kg (First Level Controlled Operating
Mode).
•
Under the scan conditions defined above, the metal spring in the
luer valve is expected to produce a maximum temperature rise of
0.2+-1.5C after 15 minutes of continuous scanning.
•
MR image quality may be compromised if the imaging area of
interest is close to the position of the luer valve and may require
optimization of MR imaging parameters.
•
In non-clinical testing using a 1.5T MRI System, the image artifact
caused by the luer valve extends approximately 72 x 44mm with
a spin echo sequence and 103 x 43mm with a gradient echo
sequence. In non-clinical testing using a 3T MRI System, the image
artifact caused by the luer valve extends approximately 30 x 27mm
with a spin echo sequence and 118 x 43mm with a gradient echo
sequence.
•
During an MRI scan the luer valve should be secured away from the
area of interest to prevent movement and image distortion.
Instructions
1. The physician should determine whether a Shiley™ neonatal or
pediatric tube should be used.
2. Prior to use, test the cuff, pilot balloon and valve for integrity.
Inflate the cuff with a volume of air indicated in Table 1. Observe
for deflation over time (2 - 10 minutes) or immerse the tube in
sterile saline for a minimum of 10 seconds and observe for air
leakage. After test inflation, completely evacuate the air. If any
leakage is noted, do not use the tube and obtain a new one.
3. Insert the obturator into the proximal end of the tracheostomy
tube. When completely seated it will protrude slightly from the
distal tip.
4. A thin film of water soluble lubricant should be applied to the
tube and protruding portion of the obturator to facilitate ease of
insertion. Insert the tube with the obturator fully seated in place.
5. After the tube is properly in place, immediately remove the
obturator and confirm proper ventilation. Store replacement tube
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