Product Description - aptus Heli-FX Instrucciones De Uso

1.0 PRODUCT DESCRIPTION

Heli-FX Applier
The Heli-FX Applier is a sterile, single-patient use disposable device designed to implant one
EndoAnchor at a time. EndoAnchors are loaded into the Applier from the EndoAnchor Cassette
by placing the distal end of the Applier into an unused EndoAnchor Port that each holds one
EndoAnchor.
CAUTION: The EndoAnchor has a sharpened leading edge – use caution when handling the Applier
with a loaded EndoAnchor.
The Heli-FX Applier can be reloaded and deployed multiple times for the same patient. The Applier
is composed of a catheter and control handle. On the control handle are indicator lights and
control buttons. The control handle contains a 9-volt alkaline battery-powered motor, which
controls EndoAnchor rotation. Figure 1 provides details on the indicator lights and control buttons.
The Applier catheter is passed through the lumen of the Heli-FX Guide until the distal end of the
Applier contacts the endograft and vessel wall.
The Applier is available in two working lengths - 86 cm and 114 cm.
Classifications
• Internally Operated Equipment
• Type CF (Defibrillation-Proof) Applied Part
• Water Ingress Type IPX0
• Equipment not suitable for use in the presence of a Flammable Anesthetic mixture with air
or with oxygen or nitrous oxide.
• Mode of Operation: Continuous Operation
The EndoAnchor is implanted in a two-stage process, allowing the physician to retract the
EndoAnchor and re-position prior to final deployment. Audible tones and visible lights during
operation indicate the position of the EndoAnchor and the available direction of motion.
Figure 1 details the components of the Heli-FX Applier.
Forward Control Button
Heli-FX® EndoAnchor® System
Reverse Control Button
Figure 1: Heli-FX Applier
Control handle
Heli-FX Applier Catheter
Green Forward and
Reverse Indicators
Error Indicator
EN
Flush Port
2