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ACUTE HEMODIALYSIS CATHETER

ACUTE HEMODIALYSIS CATHETER - AngioDynamics XL.pdf · INDICATION FOR USE: The AngioDynamics Schon XL® Double Lumen Catheter is designed for acute hemodialysis and apheresis

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Page 1: ACUTE HEMODIALYSIS CATHETER - AngioDynamics XL.pdf · INDICATION FOR USE: The AngioDynamics Schon XL® Double Lumen Catheter is designed for acute hemodialysis and apheresis

ACUTE HEMODIALYSIS CATHETER

Page 2: ACUTE HEMODIALYSIS CATHETER - AngioDynamics XL.pdf · INDICATION FOR USE: The AngioDynamics Schon XL® Double Lumen Catheter is designed for acute hemodialysis and apheresis

USA > 603 Queensbury Avenue, Queensbury, NY 12804 > tel: 800-772-6446 or 518-798-1215 > fax: 518-798-1360International > Building 2000, Beach Drive, IQ Cambridge, Waterbeach, Cambridge, CB25 9TE > United Kingdomtel: +44 1223 729 300 > fax: +44 1223 729 349

www.angiodynamics.com

AngioDynamics is a registered trademark of AngioDynamics, Inc. HEMO-CATH, Schon XL and Vascu-Sheath are registered trademarks of Medcomp © 2010 AngioDynamics, Inc. MLC 129 Rev F 01/10

INDICATION FOR USE: The AngioDynamics Schon XL® Double Lumen Catheter is designed for acute hemodialysis and apheresis. It may be inserted percutaneously and is preferably placed in the jugular vein, although it may be inserted into the subclavian or femoral vein. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.

CONTRAINDICATIONS: This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels.

WARNINGS AND PRECAUTIONS: For single use only. Do not resterilize the catheter or accessories by any method and/or reuse. Contents sterile in unopened, undamaged package. Do not use if opened or any sign of product damage is visible. Do not use iodine or iodine-based solutions on this catheter; failure of catheter will occur. Immediately after insertion, confirm proper placement of the tip of the catheter with x-ray. Failure to verify catheter placement may result in serious trauma or fatal complications. Please see package insert for complete list of warnings and precautions.

POTENTIAL COMPLICATIONS: Procedure-related complications include: air embolus; bacteremia; brachial plexus, mediastinal or pleural injury; cardiac arrhythmia or tamponade; central venous, luminal or vascular thrombosis; endocarditis; exit-site infection; exsanguination; hematoma; hemorrhage; hemothorax or pneumothorax; laceration/perforation of the vessel or thoracic duct; punctures (right atrial, subclavian artery, superior vena cava); retroperitoneal bleed and septicemia.

Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each catheter. Observe all instructions prior to use. Failure to do so may result in patient complications or death.

IMPORTANT RISK INFORMATION

BASIC SET INCLUDES: (1) catheter, (1) 18g x 2-3/4” (7cm) introducer needle, (1) .035” x 70cm J/Flex guidewire, (1) #11 blade disposable scalpel with handle, (1) 2-0 suture w/curved needle, (1) HEMO-CATH® clip, (1) adhesive wound dressing, (1) 12F vessel dilator, (1) 14F vessel dilator, (2) injection caps

FULL SET INCLUDES: (1) catheter, (1) pair surgical gloves, (4) 4”x4” (10cm) gauze sponges, (1) fenestrated drape with clear adhesive, (2) 10 mL disposable luer lock syringes, (1) 15F Vascu-Sheath® Introducer, (2) 5 mL disposable luer lock syringes, (1) 25g x 5/8” (1.6cm) needle, (1) 22g x 1-1/2” (3.8cm) needle, (1) straight disposable steel hemostat, (1) 5 mL ampule Lidocaine HCL 1%, (1) 18g x 1-1/2” (3.8cm) needle, (1) .035” x 70cm J/Flex guidewire, (1) #11 blade disposable scalpel with handle, (1) adhesive wound dressing, (2) injection caps, (1) 18g x 2-3/4” (7cm) introducer needle, (1) HEMO-CATH clip, (1) 12F vessel dilator, (1) 14F vessel dilator, (1) 2-0 silk suture w/curved needle, (1) 3-pack Povidone Iodine swab sticks

Description Catheter Only Catheter Basic Set Catheter Full SetUnits/Box Catalog No. Units/Box Catalog No. Units/Box Catalog No.

12 cm Acute Catheter n/a n/a 5 10800704 n/a n/a

15 cm Acute Catheter 10 10801701 5 10800701 5 10802701

20 cm Acute Catheter 10 10801702 5 10800702 5 10802702

24 cm Acute Catheter 10 10801703 5 10800703 5 10802703

PHYSICIAN’S SIGNATURE

Tip clip allows versatile positioning

Removable stylet eases vessel insertion, improves catheter flexibility

Extra large side holes improve flow, reduce clotting

Soft silicone catheter is kink resistant, excellent for femoral use

Schon XL®

Acute Hemodialysis Catheter