Inhaltsverzeichnis; Product Description - Medtronic Aptus Heli-FX Gebrauchsanweisung

Aptus™ Heli-FX™ and Heli-FX Thoracic EndoAnchor™ Systems, comprising the Heli-FX Guides, Heli-FX Appliers, EndoAnchor
implants, and EndoAnchor Cassettes.
1. Product description .................................................................................................................................................................................................................. 5
2. Indications for use .................................................................................................................................................................................................................... 7
3. Contraindications ..................................................................................................................................................................................................................... 7
4. Warnings and precautions ....................................................................................................................................................................................................... 7
5. Adverse events ........................................................................................................................................................................................................................ 8
6. How supplied ............................................................................................................................................................................................................................ 8
7. Clinical data .............................................................................................................................................................................................................................. 9
8. Clinical use information ............................................................................................................................................................................................................ 9
9. Directions for use ................................................................................................................................................................................................................... 10
10. Imaging guidelines and postoperative follow-up .................................................................................................................................................................... 13
11. Definitions .............................................................................................................................................................................................................................. 13
12. Storage, transport, and disposal ............................................................................................................................................................................................ 13
13. EMC guidance and declaration .............................................................................................................................................................................................. 13

1. Product description

Heli-FX™ Applier
The Heli-FX Applier is a sterile, single-patient use disposable device designed to implant one EndoAnchor implant at a time. EndoAnchor implants are loaded into the Applier from the
EndoAnchor Cassette by placing the distal end of the Applier into an unused EndoAnchor implant port that each holds one EndoAnchor implant.
Caution: The EndoAnchor implant has a sharpened leading edge. Use caution when handling an Applier loaded with an EndoAnchor implant.
The Heli-FX Applier can be reloaded and deployed multiple times for the same patient. The Applier is composed of a catheter and a control handle. The control handle includes
indicator lights, control buttons, and a 9-volt alkaline battery-powered motor. The motor controls the EndoAnchor implant rotation. Figure 1 provides details on the indicator lights and
control buttons. The user passes the Applier catheter 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 2 lengths: 86 cm and 114 cm.
Classifications
•
Internally powered equipment
•
Type CF (defibrillation-proof) applied part
•
Type IPX0 for water ingress
•
The equipment is 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 implant is implanted in a 2 stage process to allow the physician to retract the EndoAnchor implant and reposition it prior to final deployment. Audible tones and
visible lights during operation indicate the position of the EndoAnchor implant and the available direction of motion. Figure 1 details the components of the Heli-FX Applier.
1. Control handle
2. Catheter
3. Reverse control button
4. Forward control button
Table 1 shows the Heli-FX Applier status and relevant lights, audible tones, and button definitions associated with each status.
Device Status Light
Off Off
Green Forward Arrow: Flashes
On/Self Check Sequence Reverse Arrow: Flashes
Blue Indicator Light: Flashes
Green Forward Arrow: Off
On/Ready Green Reverse Arrow: Flashes
Blue Indicator Light: Off
Green Forward Arrow: Flashes
EndoAnchor Implant Loaded Green Reverse Arrow: Off
Blue Indicator Light: Off
Table of contents
2
3
4
5
6
Figure 1. Heli-FX Applier
5. Green forward and reverse indicators
6. Error indicator
7. Flush port
Table 1. Lights, audible tones, and buttons
1
7
Tone
None
3 Tones
No Tones
2 Tones
Instructions for Use English 5