Amplatzer ML 25 Instrucciones De Uso página 5

Directions for Use
Sizing and Device Selection
Note: A Single Y-Connector Kit (B. Braun Medical, Order No. 610400) is recommended for use with
the AMPLATZER Vascular Plug.
• Perform an angiogram and measure the diameter of the vessel.
• Select a device approximately 30-50% larger than the vessel diameter.
• Flush the loader through its hoop to purge air from the loader.
• Remove the white hub clip and pull the pusher wire with the preloaded AMPLATZER Vascular
Plug from the hoop.
• Insert and advance the selected guiding catheter to the target vessel.
• Insert the loader through the Single Y-Connector and advance until it contacts the hub of the
guide catheter and flush with saline through the sidearm which purges the air from the loader.
• Advance the AMPLATZER Vascular Plug from the loader into the catheter to the target vessel.
• Remove the loader if desired.
• Verify correct position of the AMPLATZER Vascular Plug with a test injection through the
catheter. If device position is unsatisfactory, the device can be repositioned or removed
together with the catheter.
• If device position is satisfactory, release the device by rotating the pusher wire in a
counterclockwise fashion.
• More than one AMPLATZER Vascular Plug may be required to achieve occlusion of a vessel.
• If detachment is difficult, a torque device or surgical clamp may be used to assist with the
release of the device by rotating the pusher wire in a counter clockwise fashion.
MR Safe
Through non-clinical testing, the
strengths of 3.0 Tesla or less with a maximum whole body averaged specific absorption rate (SAR)
of 3.83 W/kg at 1.5 Tesla and 5.57 W/kg at 5.0 Tesla for a 20 minute exposure to a B1 of 118 µT.
The
AMPLATZER Vascular Plug
been performed to rule out the possibility of migration at field strengths higher than 3.0 Tesla.
In this testing, the device produced a temperature rise of 1.1°C at 1.5 Tesla and 1.6°C at 5.0 Tesla.
MR image quality may be compromised if the area of interest is in the exact same area or relatively
close to the position of the device.
Figure 1
AMPLATZER Vascular Plug
should not migrate in this MR environment. Non-clinical testing has not
Figure 2
has been shown to be MR safe at field
2 2
Figure 3