En • English - BIOTRONIK Selectra Slitter Manuel Technique

Outil de découpe pour le système d'implantation télescopique de sonde sc selectra
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  • FRANÇAIS, page 27
Target Group
This manual is intended for cardiologists, electrophysiologists and surgeons who are
familiar with, and have practical experience with, cardiac resynchronization therapy and
implantation of leads in the coronary venous system.
Description
The Selectra slitter tool is designed for use in conjunction with the BIOTRONIK Selectra CS
lead introducer system.
It is used to remove Selectra guiding catheters from CS leads with an outer diameter
between 4.6 and 5.8 F and can cut up to three Selectra guiding catheters.
BIOTRONIK's Selectra CS lead introducer system is a combination of CS guiding catheters
and implant accessories used to facilitate access to the coronary venous system for
suitable leads and catheters.
Intended Use, Indications
Selectra accessories are used in conjunction with the CS lead introducer system to
facilitate lead implantation in the left side of the heart via the coronary sinus.
Contraindications
Use of the Selectra CS lead introducer system is contraindicated for the following:
• Patients with an existing or possible occlusion of the coronary vessels or unsuitable
anatomy of the coronary veins
• Patients with active systemic infection
No Reuse
The Selectra slitter tool is intended for single-use only.
It must not be resterilized.
Reuse of implant accessories can result in infections, embolisms and damage to the
product.
Refer to Other Manuals
Also refer to the manuals for the CS guiding catheters and the accessories kit for the
Selectra CS lead introducer system, as well as the manual for the lead used.
Warnings and Precautions
• To inhibit blood clotting, BIOTRONIK recommends intravenously administering 
50-100 IU heparin per kg body weight if the patient is not otherwise anticoagulated.
• Only use water soluble contrast media.
Potential Negative Side Effects
Possible complications are as follows:
• Allergic reactions to contrast media
• Hematoma
• Bleeding
• Infection
• Embolism
• Pneumothorax
• Cardiac tamponade
• Myocardial damage
• Venous or cardiac perforation
• Local tissue response, fibrotic tissue formation
• Damage to the heart valves
• Vascular occlusion
• Chronic nerve damage
Storage
The product should only be stored at temperatures between 5°C and 55°C (41°F to 131°F).
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