COOK Medical Evolution Instrucciones De Uso página 7

WARNINGS
The stent is not intended to be removed or repositioned after stent
placement and is intended to remain in the body permanently. Attempts
to remove or reposition stent after placement may cause damage to
surrounding tissue or mucosa.
Stent cannot be retrieved after the deployment threshold has been
passed. Corresponding marks on outer catheter and delivery handle
indicate when threshold has been passed.
The stent contains nickel, which may cause an allergic reaction in
individuals with nickel sensitivity.
This symbol means the device is MR Conditional.
Non-clinical testing has demonstrated that this stent is MR Conditional
according to ASTM F2503. A patient with this stent can be scanned safely
immediately after placement under the following conditions.
Static Magnetic Field
• Static magnetic field of 3 Tesla or less
• Maximum spatial magnetic gradient of 720 Gauss/cm or less
Non-clinical evaluation was conducted in a 3 Tesla MR system (Excite,
General Electric Healthcare) with a maximum spatial magnetic gradient
field of 720 Gauss/cm as measured with a gaussmeter in the position of
the static magnetic field pertinent to the patient (i.e., outside of scanner
covering, accessible to a patient or individual).
MRI-Related Heating
• 1.5 and 3.0 Tesla Systems: It is recommended to scan in normal
operation mode (whole body averaged specific absorption rate (SAR) ≤
2.0W/kg). ("Normal Operating Mode" is defined as the mode of operation
of the MR system in which none of the outputs have a value that cause
physiological stress to the patient) for 15 minutes of scanning (i.e., per
scanning sequence).
• Non-clinical testing was conducted on the stent under the following
conditions, and produced a maximum temperature rise of 3.7 ˚C:
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