Directions For Use - aptus Heli-FX Instrucciones De Uso

Inspection Prior to Use
Inspect the device and packaging to verify that no damage has occurred as a result of shipping.
Do not use this device if damage has occurred or if the sterile barrier has been damaged or broken.
If damage has occurred, do not use the product and return to Aptus Endosystems, Inc. or your
distributor.
Do not use beyond the "USE BY" date indicated on the packaging.
Prior to use, verify correct devices (appropriate Heli-FX Applier and Guide models for the anatomy
being treated and sufficient quantity of EndoAnchors) have been supplied for the patient by
matching the device to the order prescribed by the physician for that particular patient.
Recommended Materials
• Heli-FX Guide with Obturator
• Heli-FX Applier with EndoAnchor Cassette
• 16 Fr or 18 Fr (or larger) introducer sheath, if desired
• 0.035" guide wire, exchange length (260 cm or greater)
• Heparinized saline for catheter flush
• Alternative guide wires and other endovascular tools, per the physician's preference

9.0 DIRECTIONS FOR USE

Prior to use of the Heli-FX EndoAnchor System, review this Instruction for Use booklet. The
following instructions embody a basic guideline for EndoAnchor placement. Variations in the
following procedures may be necessary. These instructions are intended to help guide the
physician and do not take the place of physician judgment.
General Use Information
Standard techniques for placement of arterial access sheaths guiding catheters, angiographic catheters
and guide wires should be employed during use of the Heli-FX EndoAnchor System. The Heli-FX Guide
with Obturator is compatible with 0.035 inch diameter guide wires.
Pre-Implant Planning
• Determine accurate anatomy and morphology of the intended aortic sealing zone(s) for placement
of the EndoAnchors. Table 3 indicates the appropriate Heli-FX Guide based on the native aortic
diameter being treated.
Table 3: Heli-FX Guide Tip Configuration and Vessel Diameter
Abdominal Aortic Sealing Zone
Diameter
Heli-FX Guide Tip Length
Model Number
Thoracic Aortic Sealing Zone
Diameter
Heli-FX Guide Tip Length
Model Number
Heli-FX® EndoAnchor® System
18 – 28 mm
22 mm Tip Reach
SG-64
18 – 28 mm
22 mm Tip Reach
HG-18-90-22
28 – 32 mm
28 mm Tip Reach
HG-16-62-28
28 – 38 mm
32 mm Tip Reach
HG-18-90-32
EN
38 – 42 mm
42 mm tip Reach
HG-18-90-42
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