Image Artifact; How Supplied - Medtronic Tri-Ad 900SFC Instrucciones De Uso

2012/SEP/20 at 4:07 p.m. Doc number: M951612A001 Rev. 1A [16(02)]
Printspec l - 3.75 x 6.0 inches
8.2. MRI Conditions
Nonclinical testing has demonstrated that the Tri-Ad™ Adams tricuspid
ring is Magnetic Resonance (MR) Conditional.
The device can be scanned safely under the following conditions:
■
static magnetic field of 3.0 Tesla or less
■ spatial gradient field of 2500 gauss/cm or less
■
normal operating mode only with a maximum whole body SAR of
2.0 W/kg for 15 minutes as read from the equipment monitor
RF Heating
Nonclinical testing has demonstrated a temperature rise of less than
1.6°C at a maximum whole body averaged SAR of 2.7 W/kg as assessed
by calorimetry for 15 minutes of MR scanning in a 3.0 Tesla (128 MHz)
MR System using a transmit/receive body coil (Excite, HDx, Software
14X.M5, General Electric Healthcare).
Deflection and Torsion
The device should not move or migrate when exposed to MR scanning
immediately after implantation. MRI at 3.0 Tesla or less may be
performed immediately following the implantation of the device.

Image Artifact

MR image quality may be compromised if the area of interest is in the
same area, or relatively close to the position of the device. It may be
necessary to optimize MR imaging parameters for the presence of this
implant. When tested at 3.0 Tesla, the image artifact extended less than
15 mm beyond the device for the spin echo sequence with repetition time
(TR) = 500 ms and echo time (TE) = 20 ms and less than 20 mm beyond
the device for the gradient echo sequence with TR = 100 ms, TE = 15 ms
and flip angle = 30°.
The presence of other implants or medical circumstances of the patient
may require lower limits on some or all of the above parameters.

9. How Supplied

9.1. Packaging
The Tri-Ad™ Adams tricuspid ring model 900SFC is available in the
following sizes for the tricuspid valve: 26, 28, 30, 32, 34, and 36 mm. The
products are nonpyrogenic. They are sterilized using irradiation, and
supplied in double-aseptic transfer pouches contained in an outer carton.
The packaging system is designed to ease placement of the device into
the sterile field. The ring assembly is sterile if the pouches are
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Instructions for Use English 15