aptus Heli-FX Instrucciones De Uso página 8

EN
Table 1 shows the Heli-FX Applier status and relevant lights, audible tones, and button definitions
associated with each status.
Device Status
Off
On/Self Check
Sequence
On/Ready
EndoAnchor
Loaded
Deployed to
Pause State
Deployment
Complete
Error
Button Actions:
Forward Control
Button:
Reverse Control
Button:
Aptus EndoAnchor and EndoAnchor Cassette
The EndoAnchor is designed to attach an endograft to the vessel wall. The EndoAnchor is manufactured
from 0.5 mm diameter medical-grade wire. The EndoAnchor is approximately 4.5 mm in total length and
approximately 3 mm in diameter. The leading end is sharpened to facilitate atraumatic deployment
through the graft material and vessel wall. The EndoAnchor can also penetrate normal to diffuse
calcified tissue up to 2.0 mm thick. The cross-bar located at the proximal end of the EndoAnchor
prevents over penetration of the EndoAnchor. The body of the EndoAnchor is helical-shaped
allowing the EndoAnchor to engage tissue and secure attachment of the endograft to the vessel wall.
Ten EndoAnchors are packaged in a sterile cassette allowing for easy and accurate loading into
the Heli-FX Applier. Figure 2 is an illustration of the EndoAnchor. Figure 3 is an illustration of the
EndoAnchor Cassette.
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Table 1: Lights, Audible Tones, and Buttons
Light
Off
Green Forward Arrow: Flashes
Reverse Arrow: Flashes
Blue Indicator Light: Flashes
Green Forward Arrow: Off
Green Reverse Arrow: Flashes
Blue Indicator Light: Off
Green Forward Arrow: Flashes
Green Reverse Arrow: Off
Blue Indicator Light: Off
Green Forward Arrow: Flashes
Green Reverse Arrow: Flashes
Blue Indicator Light: Off
Green Forward Arrow: Off
Green Reverse Arrow: Flashes
Blue Indicator Light: Off
Green Forward Arrow: Off
Green Reverse Arrow: Flashes
Blue Indicator Light: Flashes
Deploys an EndoAnchor Forward
(a) Turns Heli-FX Applier On; (b) Loads an EndoAnchor; or (c) Withdraws
an EndoAnchor back in to the Applier from the Pause State
Tone
None
3 Tones
No Tones
2 Tones
4 Tones
3 Tones
4 Tones