aptus Heli-FX Instrucciones De Uso página 20

EN
• Flush the inner lumen of the Heli-FX Applier with heparinized saline via the flush port.
• Load the Applier by firmly pressing the middle of the Reverse Control Button. While the motor
is running, insert the distal end of the Applier catheter into an unused EndoAnchor Port on
the EndoAnchor Cassette. Figure 7 shows examples of used and unused EndoAnchor Ports.
The reverse green arrow will flash and the EndoAnchor will be loaded from the cassette into
the distal end of the Heli-FX Applier. When the EndoAnchor is loaded, two audible tones can
be heard, and the forward green arrow will flash, indicating the first stage of EndoAnchor
deployment is ready. The EndoAnchor is now loaded into the Applier, and the Applier can
be removed from the cassette.
NOTE: Verification of the loaded EndoAnchor may be done by visually inspecting the distal tip
of the Heli-FX Applier.
EndoAnchoring Procedure
• Ensuring the Guide control handle is stabilized; insert the tip of the loaded Applier through
the hemostatic seal of the control handle.
• Position the Guide at the desired location for EndoAnchor placement (See Figure 6).
– The EndoAnchors should be placed within the desired sealing zone, typically within the
most proximal or most distal endograft stent.
– EndoAnchors should be as evenly distributed around the circumference of the sealing
stent as possible.
– The recommended minimum number of EndoAnchors is based on endograft type
(bifurcated or tube), vessel angulation, and native vessel diameter, and is independent
of the amount of endograft oversizing. Recommended minimums are conservative, based
on theoretical worst-case modeling, and incorporate the results of accelerated durability
testing demonstrating the ability of the EndoAnchor/endograft interface to withstand the
calculated cyclic loading. See Table 4 and Table 5. Additional or fewer EndoAnchors may
be placed at physician discretion.
Table 4: Recommended Minimum Numbers of EndoAnchors – Bifurcated Endografts
Aortic Neck Diameter
(Proximal)
30 – 32 mm
15
Unused EndoAnchor
Port
Figure 7: EndoAnchor Cassette
≤ 29 mm
Graft Angulation
≤ 60˚
4
6