How Supplied - aptus Heli-FX Instrucciones De Uso

EN
Adverse Event Reporting
Any complaints (including Adverse Events, Unanticipated Adverse Device Effects, and Incidents)
involving the Heli-FX EndoAnchor System should be reported to Medtronic Vascular immediately.
Complaints may be reported by:
Telephone
Facsimile
E-mail

6.0 HOW SUPPLIED

The Heli-FX EndoAnchor System components (Heli-FX Guide, Heli-FX Applier and Cassette with
EndoAnchors) are supplied in separate sterile packaging. Included in the Heli-FX Applier package is
one EndoAnchor Cassette containing 10 preloaded EndoAnchors.
Do not use after the "USE BY" (expiration) date printed on the label.
Table 2 details the available components of the Heli-FX EndoAnchor Systems.
System
Heli-FX System
(16 Fr outer diameter;
62 cm working length)
Heli-FX Thoracic System
(18 Fr outer diameter;
90 cm working length)
The Heli-FX devices are intended for single use only. Do not re-use or re-sterilize the devices.
• Reprocessing or reuse of single-use devices may compromise the structural integrity of the
device, essential material and design characteristics and/or lead to device failure.
• Reuse of single-use devices creates a potential risk of patient or user infections. Contamination
of the device may lead to injury, illness or death of the patient.
• This product was tested for electrical safety for the intended single use only. Any reuse may
pose the risk of electrical shock, insufficient isolation and elevated temperatures above those
intended for the components.
9
(800) 465-5533 (USA only, toll-free)
+1 (651) 367-0735
dl.vasc-fieldassurance@medtronic.com
Table 2: Heli-FX System Components
Heli-FX Applier with EndoAnchor Cassette
(containing 10 EndoAnchors)
Heli-FX Guide (22 mm reach)
Heli-FX Guide (28 mm reach)
Heli-FX Applier with EndoAnchor Cassette
(containing 10 EndoAnchors)
Heli-FX Guide (22 mm reach)
Heli-FX Guide (32 mm reach)
Heli-FX Guide (42 mm reach)
Component Model Number
SA-85
SG-64
HG-16-62-28
HA-18-114
HG-18-90-22
HG-18-90-32
HG-18-90-42