aptus Heli-FX Instrucciones De Uso página 21

Table 5: Recommended Minimum Numbers of EndoAnchors – Tube Endografts
Aortic Neck Diameter
(Proximal or Distal)
≤ 29 mm
30 – 32 mm
33 – 36 mm
37 – 40 mm
> 40 mm
CAUTION: EndoAnchors should not be placed in unsupported endograft sections or sections of grafts
where the stents are not fully attached to the graft fabric.
• Under fluoroscopic guidance, advance the Applier through the Guide until the Applier emerges
from the distal end of the Guide and makes contacts with the endograft. Slowly, continue to
advance the Applier until resistance is felt indicating the Applier is firmly pushing the endograft
against the vessel wall. Deflection of the Guide away from the endograft should be visualized
under fluoroscopy.
NOTE: It is recommended to implant EndoAnchors in a lateral view as shown in Figure 8. In this
orientation the Heli-FX Guide's distal C-marker appears as a solid straight line. If, upon advancement
of the Applier, the distal C-marker of the Guide changes from a straight line to resemble a "C" shape,
this indicates that the Applier is no longer perpendicular to the endograft (see Figure 9). If this
occurs, the apposition force should be reduced by slightly retracting the Applier, and the Guide
re-positioned as necessary. See Figure 8 for proper implant orientation. Attempting to implant
EndoAnchors in a tangential orientation may result in implant difficulty and suboptimal endograft
fixation and/or sealing.
• Using the control handle of the Heli-FX Applier, firmly press the middle of the Forward Control
Button for the first stage of EndoAnchor deployment. The EndoAnchor will partially deploy and
PAUSE. Four (4) audible tones should be heard and the forward and reverse arrow lights will
alternate indicating that the operator may continue deployment or withdraw the EndoAnchor
back into the Applier.
• NOTE: If the EndoAnchor is not in the desired location, firmly press the middle of the Reverse
Control Button to re-house the EndoAnchor inside the Applier and reposition.
Heli-FX® EndoAnchor® System
Graft Angulation
≤ 60˚
4
4
4
5
5
> 60˚ – 75˚
4
4
5
6
7
EN
> 75˚ – 90˚
4
5
7
8
9
16