Medtronic Aptus Heli-FX Gebrauchsanweisung Seite 8

Device Status Light
Green Forward Arrow: Flashes
Deployed to Pause State Green Reverse Arrow: Flashes
Blue Indicator Light: Off
Green Forward Arrow: Off
Deployment Complete Green Reverse Arrow: Flashes
Blue Indicator Light: Off
Green Forward Arrow: Off
Error Green Reverse Arrow: Flashes
Blue Indicator Light: Flashes
Button Actions
Forward Control Button Deploys an EndoAnchor Implant Forward
Reverse Control Button (a) Turns Heli-FX Applier On; (b) Loads an EndoAnchor Implant; or (c) Withdraws an EndoAnchor Implant back in to the Applier from the Pause State
Aptus EndoAnchor Implant and EndoAnchor Cassette
The EndoAnchor implant is designed to attach an endograft to the vessel wall. The EndoAnchor implant is manufactured from 0.5 mm diameter medical-grade wire. The EndoAnchor
implant is approximately 4.5 mm in total length and approximately 3 mm in diameter. The sharp, leading end facilitates atraumatic deployment through the graft material and vessel
wall. The EndoAnchor implant also penetrates diffusely calcified tissue up to 2.0 mm thick. The cross-bar located at the proximal end of the EndoAnchor implant prevents
overpenetration of the EndoAnchor implant. The body of the EndoAnchor implant has a helical shape, allowing the EndoAnchor implant to engage tissue and attach the endograft to
the vessel wall. Figure 2 is an illustration of the EndoAnchor implant. 10 EndoAnchor implants are packaged in a sterile cassette allowing for easy and accurate loading into the Heli-
FX Applier. Figure 3 is an illustration of the EndoAnchor Cassette supplied with the Heli-FX Applier. Additional EndoAnchor implants are available in an Ancillary EndoAnchor
Cassette containing 5 EndoAnchor implants.
1. Crossbar
2. Leading end
1. EndoAnchor ports
Heli-FX Guide with obturator
The Heli-FX Guide is a sterile, single patient use, disposable device that directs the Heli-FX Applier to the desired location for the implantation of EndoAnchor implants. The Heli-FX
Guide consists of a steerable guide catheter and control handle. The obturator (included with the Heli-FX Guide) has an atraumatic tip. The thoracic obturator has a radiopaque
marker within 2 mm of its tip. The obturator, which is compatible with a 0.89 mm (0.035 in) guidewire, allows the Guide to be advanced over the wire within the patient's vasculature.
Rotating the deflector knob on the control handle allows the distal tip of the Heli-FX Guide to be deflected in a single direction or straightened
A C-shaped radiopaque marker, located at the distal tip of the Heli-FX Guide, aids in orientation under fluoroscopy. A straight radiopaque marker, located at the outer curve of the
deflectable section of the Guide, indicates the direction of tip deflection. Figure 4 details the components of the Heli-FX Guide.
1. Control handle
2. Guide catheter
3. Radiopaque markers
4. Deflector knob
6 Instructions for Use English
1
2
Figure 2. EndoAnchor Implant
Figure 3. EndoAnchor Cassette
2
3
4
Figure 4. Heli-FX Guide with obturator
Tone
4 Tones
3 Tones
4 Tones
1
1
5
6
7
5. Obturator
6. Hemostatic seal
7. Flush port