Imaging Guidelines And Post-Operative Follow-Up - aptus Heli-FX Instrucciones De Uso

• Remove the guide wire and then the Obturator to minimize blood loss through the hemostatic
seal on the Heli-FX Guide.
CAUTION: After the Obturator is withdrawn, the Heli-FX Guide can be used to hand inject contrast
to confirm proper endograft position prior to EndoAnchoring. Prior to any hand injection, aspirate
the Guide using a syringe attached to the one-way valve on the back of the Guide control handle
to prevent potential air ingress. Do not use a power injector to perform angiography through the
Heli-FX Guide.
• Under fluoroscopic guidance, deflect the distal tip of the Heli-FX Guide toward the first
EndoAnchor implant location by rotating the Deflector Knob on the control handle clockwise.
NOTE: The C-shaped and straight radiopaque markers on the distal end of the Heli-FX Guide provide
assistance with visual orientation under fluoroscopy. In an anterior/posterior view, the "C" marker
will appear as a straight line transverse to the axis of the catheter when the catheter is orientated
laterally, as a "C" when oriented anteriorly, and as a reverse "Ɔ" when oriented posteriorly. In the
lateral view, position the straight radiopaque marker on the opposite side of the intended
deployment surface. The Guide tip will deflect in the opposite direction relative to the straight
marker, when the control knob is rotated.
Straight marker
EndoAnchor
deployment
location
Figure 6: Direction of Guide Deflection Relative to Straight Marker
Heli-FX Applier Preparation
• Select the appropriate length of Heli-FX Applier based on the Guide being used and anatomical
location being treated.
• To turn on the Heli-FX Applier, firmly press and hold the middle of the Reverse Control Button
for at least five (5) seconds, or until the motor initiates. 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 the Applier is ready to load the first EndoAnchor. 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 the device is non-functional. If the blue indicator light illuminates, replace the Applier with
a new one and repeat the sequence for turning on.
Heli-FX® EndoAnchor® System
Direction of
Guide deflection
EN
Straight marker
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