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  • X-Force® Nephrostomy Balloon Dilation Catheter

    2-English 4-French/Français 6-German/Deutsch 8-Italian/Italiano 10-Spanish/Español 12-Dutch/Nederlands 14-Portuguese/Português 16-Greek/ÅëëçíéêÜ 18-Danish/Dansk 20-Swedish/Svenska 22-Finnish/Suomi 24-Norwegian/Norsk 26-Polish/Polski 28-Hungarian/Magyar 30-Czech/Český 32-Turkish/Türkçe

    Instructions for Use

    PK0309767 06/2017

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    X-Force® Nephrostomy Balloon Dilation Catheter

    Instructions for Use Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

    Description The X-Force® Nephrostomy Balloon Dilation Catheter is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and a radiopaque marker beneath the balloon. The lumen labeled with rated burst pressure (XX ATM) is for balloon inflation. The other lumen allows the catheter to track over a 0.038” (.97mm) diameter guidewire and can be used for monitoring of pressure or the infusion of medication and/or contrast medium. Each balloon inflates to a stated diameter and length at a specific pressure – typically at 10 atm.

    The balloon dilation catheter comes packaged with a refolding tool and a working sheath. It is available with or without an inflation device. It comes sterile and is for single use only.

    Indications for Use The X-Force® Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

    Contraindications Do not use the X-Force® Nephrostomy Balloon Dilation Catheter in the presence of conditions which create unacceptable risk during the dilation of the nephrostomy tract.

    Warnings: • If resistance is felt when removing either the catheter or the guidewire from the working sheath, stop and

    consider removing them as a single unit to prevent damage to the product. Applying excessive force to the catheter can result in tip breakage or balloon separation.

    • Do not use air or any gaseous substances as a balloon inflation media, always use sterile liquid media. • This is a single use device. Do not re-sterilize any portion of this device. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or

    essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.

    Precautions: • Only a physician who has an understanding of the clinical applications, technical principles and associated

    risks associated with balloon dilation of the nephrostomy tract should use this device. • After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted

    medical practice and with applicable laws and regulations.

    Potential Complications The complications that may arise from a balloon dilation procedure include tissue trauma and perforation.

    Inspection Prior to Use The X-Force® Nephrostomy Balloon Dilation Catheter is a sterile, single use device. Carefully inspect the catheter and the sterile packaging for signs of damage that may have occurred during shipment. Do not use the product if damage is evident.

    Preparation of the Catheter All X-Force® Nephrostomy Balloon Dilation Catheters contain air in the balloon lumen. The air must be removed to allow liquid to fill the balloon when it is inflated. 1. Remove the protective sheath from the balloon. 2. Attach the inflation device to the connector on the balloon lumen. 3. Open the stopcock, and draw back on the inflation device to remove the air from the balloon catheter 4. Close the stopcock, remove the inflation device, depress the plunger to remove any air and reattach to the

    balloon catheter. 5. Repeat steps 3-4 until all air is removed from the balloon lumen.

    Catheter Insertion 1. Prior to insertion, place the working sheath over the balloon and position it proximal to the balloon.

    Note: Dilation procedures should be conducted under fluoroscopic guidance with appropriate X-ray equipment or direct vision.

    2. Introduce the catheter carefully over a 0.038” (.97mm) guidewire and place it in the area that needs to be dilated. Use the radiopaque marker to aid in proper positioning.

    Caution: Do not advance or withdraw the catheter or guidewire against any significant resistance. The cause of the resistance must be determined fluoroscopically and remedial action taken.

    English

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    Inflating the Balloon Catheter 1. Fill the inflation device (eagle™ inflation device) with sterile, liquid media. 2. Attach the inflation device to the balloon lumen. 3. Open the stopcock and inflate the balloon. 4. Once dilation has been attained, advance the sheath over the balloon.

    Warning: Do not use air or any gaseous substances as a balloon inflation media, always use sterile liquid media.

    Note: The use of an inflation device with a pressure gauge is highly recommended to make sure adequate pressure is applied and the maximum limits of the balloon are not exceeded.

    Note: Slight reduction in balloon pressure may be required if resistance is encountered when advancing the sheath over the balloon.

    Caution: Do not exceed the recommended rated burst pressure (RBP) for this device. Balloon rupture may occur if the RBP rating is exceeded. Please refer to the device label for the recommended RBP.

    Deflating the Balloon Catheter Deflate the balloon using an inflation device. Since deflation times vary based on balloon sizes and lengths, check fluoroscopically to confirm deflation before attempting to withdraw.

    1. Attach the inflation device (eagle™ inflation device) and remove the solution from the balloon by pulling back on the inflation device.

    2. Remove the inflation device from the balloon catheter. This will allow ambient pressure to enter, relaxing the balloon.

    3. Gently withdraw the catheter. Use of a gentle counterclockwise twisting motion is recommended when removing the catheter.

    Warning: If resistance is felt when removing either the catheter or the guidewire from the working sheath, stop and consider removing them as a single unit to prevent damage to product. Applying excessive force to the catheter can result in tip breakage or balloon separation.

    Using the Refolding Tool The balloon catheter is supplied with a refolding tool. This aids in preparing the balloon for another insertion during the procedure. To use:

    1. Manually compress the balloon. 2. Position the refolding tool at one end. 3. Twist the refolding tool counter clockwise and push down on the balloon until it goes the entire length of

    the balloon. 4. Once the balloon is folded, remove the refolding tool and proceed with the procedure.

    Storage Store in a cool, dry and dark place. Do not store near radiation or ultraviolet light sources as these may damage product materials.

    Bard, Eagle and X-Force are trademarks and/or registered trademarks of C. R. Bard, Inc.

    Copyright ©2017 C. R. Bard, Inc. All Rights Reserved.

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    French/Français Cathéter de dilatation à ballonnet pour néphrostomie X-Force®

    Mode d’emploi Attention : selon la loi fédérale américaine, ce dispositif ne peut être vendu que par un médecin ou sur prescription médicale.

    Description Le cathéter de néphrostomie X-Force® pour dilatation par ballonnet est un cathéter à double lumière muni d’un ballonnet de 24 (8 mm) ou 30 Fr. (10 mm) sur son extrémité distale. L’un de ses embouts est radio-opaque et présente un marqueur radio-opaque sous le ballonnet. La lumière marquée d’une valeur de pression maximum recommandée (XX ATM) sert à gonfler le ballonnet. L’autre lumière permet au cathéter d’avancer sur une sonde de 0,97 mm de diamètre et elle peut également servir à surveiller la pression ou la perfusion de médicament et/ou le produit de contraste. Chaque ballonnet est gonflé à un diamètre et à une longueur établis, à une pression spécifique, généralement 10 atm.

    Le cathéter de dilatation à ballonnet est livré avec un outil de repliage et une gaine de travail. Il est disponible avec ou sans dispositif de gonflement. Il est livré stérile et est à usage unique.

    Indications Le cathéter de néphrostomie X-Force® pour dilatation par ballonnet est recommandé pour une dilatation dans le cadre d’une néphrostomie et pour la mise en place de la gaine de travail.

    Contre-indications Ne pas utiliser le cathéter de néphrostomie X-Force® pour dilatation par ballonnet en cas de pathologies qui présenteraient un risque inconsidéré au cours de la dilatation dans le cadre d’une néphrostomie. Avertissements: • En cas de résistance lors du retrait du cathéter ou de la sonde de la gaine de travail, arrêter et envisager

    leur retrait en un seul bloc afin d’éviter d’endommager le produit. Une force excessive appliquée au cathéter risquerait de casser son embout ou de détacher le ballonnet.

    • Ne pas utiliser d’air ou autre substance gazeuse pour gonfler le ballonnet, toujours utiliser un liquide stérile.

    • Ce dispositif est à usage unique. Ne restériliser aucune partie de ce dispositif. Une réutilisation et/ou un ré-emballage peut créer un risque d’infection pour le patient ou l’utilisateur, compromettre l’intégrité structurale et/ou le matériau essentiel et les caractéristiques de conception du dispositif, ce qui est susceptible de condu