Medtronic Aptus Heli-FX Gebrauchsanweisung Seite 13

1. Straight marker
2. Direction of Guide deflection
3. Straight marker
4. EndoAnchor implant deployment location
Heli-FX Applier preparation
1. Select the appropriate length of Heli-FX Applier based on the Guide being used and the anatomical location being treated.
2. To turn on the Heli-FX Applier, firmly press and hold the middle of the Reverse Control button for at least 5 seconds, or until the motor starts. This will initiate a self-check
sequence with audible tones and visible green lights. At the end of this sequence, the reverse green arrow will be flashing, indicating that the Applier is ready to load the first
EndoAnchor implant. Figure 1 provides an illustration of the Heli-FX Applier control handle.
Caution: If at the end of the self-check sequence the blue indicator light is illuminated, the Heli-FX Applier has encountered an error and should not be used. The blue light
indicates an internal problem and that the device is nonfunctional. If the blue indicator light illuminates, replace the Applier with a new one and repeat the sequence for turning it
on.
3. Flush the inner lumen of the Heli-FX Applier with heparinized saline via the flush port.
4. 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
implant port on the EndoAnchor Cassette. Figure 7 shows examples of used and unused EndoAnchor ports. The reverse green arrow will flash and the EndoAnchor implant will
be loaded from the cassette into the distal end of the Heli-FX Applier. When the EndoAnchor implant is loaded, 2 audible tones can be heard, and the forward green arrow will
flash, indicating that the first stage of EndoAnchor implant deployment is ready. The EndoAnchor implant is now loaded into the Applier, and the Applier can be removed from the
cassette.
1. Unused EndoAnchor port
2. Used EndoAnchor port
Note: Verification of the loaded EndoAnchor implant may be done by visually inspecting the distal tip of the Heli-FX Applier.
Implant the EndoAnchor Implant
1. Ensure that the Guide control handle is stabilized and insert the tip of the loaded Applier through the hemostatic seal of the control handle.
2. Position the Guide at the desired location for EndoAnchor implant placement (See Figure 6).
•
Place the EndoAnchor implants within the desired sealing zone, typically within the most proximal or most distal endograft stent
•
Distribute the EndoAnchor implants as evenly as possible around the circumference of the sealing stent
•
The recommended minimum number of EndoAnchor implants is based on endograft type (bifurcated or tube), vessel angulation, and native vessel diameter, and is
independent of the extent of endograft oversizing. Recommended minimums are conservative, based on theoretical worst-case modeling, and incorporate the results of
accelerated durability testing to demonstrate the ability of the interface between the EndoAnchor implant and endograft to withstand the calculated cyclic loading.
See Table 4 and Table 5. Additional or fewer EndoAnchor implants may be placed at the physician's discretion. An Ancillary EndoAnchor Cassette is available when up
to 5 additional EndoAnchor implants (15 total) are desired beyond the EndoAnchor implants supplied with each Heli-FX Applier. For procedures requiring more than
15 EndoAnchor implants, multiple Appliers must be used.
3
4
Figure 6. Direction of Guide deflection relative to straight marker
1
Figure 7. EndoAnchor Cassette
Table 4. Recommended minimum numbers of EndoAnchor implants – bifurcated endografts
Aortic neck diameter (Proximal)
≤ 29 mm
30-32 mm
2 1
2
Graft angulation
≤ 60°
4
6
Instructions for Use English 11