Description Of Symbols - Eucatech Resistant Gebrauchsanweisung

Table of contents
1 Description ..................................................................................................................17
2

Description of symbols ...............................................................................................17

3 Indications ...................................................................................................................18
3.1 Selection of RESISTANT stent system ................................................................18
4 Contraindications ........................................................................................................18
5 Potential complications ...............................................................................................19
6 Recommended drug treatment ....................................................................................20
7 Warnings .....................................................................................................................20
8 Precautions ..................................................................................................................20
8.1 RESISTANT Stent System Handling - Precautions .............................................21
8.2 Stent Placement - Precautions ...............................................................................21
8.3 Warning instructions for removal of the RESISTANT Stent System ...................22
8.4 Precautions following implantation ......................................................................22
8.5 Restenosis treatment - precautions ........................................................................22
8.6 Patient information from the physician .................................................................22
9 Individualisation of treatment .....................................................................................23
10 Preparation and execution ...........................................................................................23
10.1 Aseptic removal ....................................................................................................23
10.2 Inspections prior to use .........................................................................................23
10.3 Material required ...................................................................................................23
10.4 Selection of the stent system .................................................................................24
10.5 Application with twist grip ...................................................................................24
10.6 Application with Y connector (slide concept).......................................................25
10.7 Termination procedure ..........................................................................................26
11 Disposal.......................................................................................................................26
12 Complaints ..................................................................................................................26
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Please read these Instructions for Use carefully before using the product. Also observe the information on the
package labelling. Complications may occur if the Instructions for Use and the package labelling are not read
and understood. This product may only be used by doctors trained and experienced in the PTA
1 Description
"RESISTANT" is a self-expandable peripheral stent system with a stent made of a nickel titanium alloy.
The system consists of two components:
The 5 French delivery system is done via a 0.021" (0.53 mm) or 0.018" (0.46 mm) guide wire and the 6 French delivery
system via a 0.035" (0.89 mm) guide wire.
The technical specifications of each of the systems are included in the labels on the sterile and commercial packaging.
2 Description of symbols
Description
This RESISTANT stent system was sterilized with EO gas.
Do not use if the package is open or damaged.
Do not use after the expiration date.
STERILE - DO NOT RESTERILIZE - FOR SINGLE USE ONLY
No liability is assumed for resterilization, reprocessing or multiple use.
Store between 5°C and 40°C.
Protect against sunlight.
Keep dry.
Fragile, handle with care.
This product is intended for single use only. After reprocessing, the single-use products of eucatech AG may have the
following defects:
structural damage
•
deterioration of functional and / or material properties
•
insufficient sterility
•
insufficient absence of pyrogenic substances
•
presence of particles and endotoxins
•
residue or occurrence of hazardous substances through cleaning, disinfection or resterilization.
•
1
Percutaneous Transluminal Angioplasty
1
Percutaneous Transluminal Angioplasty
1
procedure.
1
1. Stent (self-expandable)
2. Delivery system
Pictogram
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