St. Jude Medical CPS AIM 410140 Manuals

CPS Aim™ Inner Catheter CPS AIM™ INNER CATHETER INSTRUCTIONS FOR USE Table of Contents EN English ............................. 1 CS Česky ............................... 5 DA Dansk ............................... 9 DE Deutsch .......................... 13 EL Ελληικά .......................... 17 ES Español .......................... 21 ET Eesti ............................... 25 FI Suomi ............................. 29 FR Français ......................... 33 HU Magyar ........................... 37 IT Italiano ............................ 41 JA 日本語 ............................ 45 KO 한국어 ............................ 49 LT Lietuvių k. ....................... 53 NL Nederlands ..................... 57 PL Polski ............................. 61 PT Português ....................... 65 RU На русском языке ........ 69 SK Slovenčina ..................... 73 SV Svenska ......................... 77 ZH 简体中文 ......................... 81 CPS Aim™ Inner Catheter 1 English CPS AIM™ INNER CATHETER INSTRUCTIONS FOR USE CAUTION U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. DESCRIPTION The St. Jude Medical CPS Aim™ inner catheter is used to facilitate left heart lead delivery during cardiac resynchronization therapy (CRT) procedures. The CPS Aim™ inner catheter is an introducer sheath that facilitates cannulation of the coronary sinus or subselection of branch veins off of the coronary sinus/great cardiac vein during surgical implantation procedures. It may also be used for the delivery of contrast medium and St. Jude Medical devices, including guidewires. When used in conjunction with the St. Jude Medical CPS Direct™ SL slittable outer guide catheter, the CPS Aim™ inner catheter can function as a dual-catheter assembly. The St. Jude Medical CPS Aim™ inner catheter is available in eight different curve configurations: three for cannulation (Figure 1.) and five for subselection (Figure 2.). Figure 1. CPS Aim™ Inner Catheter (Cannulator) Model Curve Shape Catheter Type 410140 CSL Cannulator 410141 90° Curve Cannulator 410142 Hockey Stick Cannulator 410144 90° Standard Subselector 410145 90° Flex Subselector 410146 Acute Subselector 410147 Obtuse Subselector 410148 90° Support Subselector READ INSTRUCTIONS FOR USE PRIOR TO USE OF THIS DEVICE 2 Figure 2. CPS Aim™ Inner Catheter (Subselector) INDICATIONS The St. Jude Medical CPS Aim™ inner catheter is designed for intracardiac access of the coronary sinus and subselection of the venous system of the heart, and to serve as a conduit during implantation of active implant medical devices for delivery of contrast medium and St. Jude Medical devices, including guidewires. In addition, CPS Aim™ inner catheters can work with outer guide catheters as a system. COMPLICATIONS As with any catheterization procedure, potential complications include thromboembolism, local and systemic infection, bleeding or hematoma at the puncture site, vascular dissection or perforation, cardiac perforation, and cardiac tamponade. WARNINGS • This is a single-use disposable medical device. The contents of this package are sterile if the package is unopened and undamaged. Do not resterilize. • Do not attempt to insert a guidewire (or other device) that is larger than the size specified on the package label. • This device is not compatible with magnetic resonance imaging (MRI) systems. PRECAUTIONS • Do not alter this device. • Inspect all components prior to use. • Do not reuse this device. Thorough cleaning of biological and foreign material is not possible. Adverse patient reactions may result from reuse of this device. • Vascular and/or cardiac perforation may occur during use. If resis- tance is encountered, DO NOT FORCE THE CATHETER. Withdraw the catheter, correct the difficulty, and reinsert. • This catheter should only be maneuvered under fluoroscopic guid- ance. • Precautions to prevent clotting should be taken whenever entering the vascular system. The patient’s clotting system should be evalu- ated prior to catheterization. • Use anticoagulant as training and experience may dictate. • Flush the lumen with normal saline prior to use in the patient. • Exercise caution when using movable core guidewires. Avoid twist- ing or excessive force on guidewires, which may cause core wire to penetrate the coil spring of the guidewire and damage the catheter or vessel. • Care must be taken to avoid damage to the wall of the vessels through which these catheters pass. • Upon withdrawal of the inserted devices, aspiration followed by flush- ing is recommended to remove any fibrin accumulation. • Do not allow liquids or objects to penetrate the housing of the cathe- ter. • Do not expose to organic solvents. • This device should only be used with equipment that complies with international safety standards. • Stretching and/or kinking of the catheter may result in damage. Han- dle with care. • Dispose of this device according to standard hospital procedures. • For specific details in the use of electrophysiology devices and the techniques employed in an electrophysiology study, refer to the med- ical literature and rely on training and practical experience.