PEDIATRIC SPLIT CATH® Indications for Use: The Medcomp® Pediatric Split Cath® is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis and in pediatric, adolescent, and adult patients as determined by the prescribing physician. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian and femoral vein. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. SPLIT CATH® Indications for Use: The Split Cath® Catheter is indicated for short-term or long-term use where vascular access is required for 14 days or more for the purpose of hemodialysis. Contraindications: Known or suspected allergies to any of the components of the catheter or the kit. This device is contraindicated for patients exhibiting severe, uncontrolled coagulopathy or thrombocytopenia. SPLIT CATH® III Indications for Use: The Medcomp® Split Cath® III Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis in adult patients. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and inferior vena cava as required. Catheters greater than 40cm are intended for femoral vein insertion or cava insertion. Translumbar insertion via inferior vena cava is indicated when all other access sites are identified as non-viable. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. SPLIT STREAM® Indications for Use: The Medcomp® Split-Stream® is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are intended for femoral vein insertion. Contraindications: This catheter is intended for Long-Term vascular access only and should NOT be used for any purpose other than indicated in these instructions. To maintain peak performance of the Split-Stream® extension set, it is recommended that the extension set be replaced every 6 months. 6.5 TESIO® Indications for Use: The Medcomp® 6.5F Bio-Flex® Catheter is designed for long-term hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian vein, the internal jugular vein of an adult patient is the preferred site. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. To maintain peak performance, it is recommended that this catheter be replaced after 18 months usage. To maintain peak performance of the adaptors, it is recommended that the adaptors be replaced every 6 months. TESIO® Indications for Use: The Medcomp® Tesio® Catheter is designed for longterm hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian vein, the internal jugular vein of an adult patient is the preferred site. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. To maintain peak performance, it is recommended that this catheter be replaced after 18 months usage. To maintain peak performance of the adaptors, it is recommended that the adaptors be replaced every 6 months. TITAN HD Indications for Use: The Medcomp® Titan HD is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein as required. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. HEMO-FLOW® Indications for Use: The Medcomp® Hemo-Flow® Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are intended for femoral vein insertion. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. HEMO-FLOW® XF Indications for Use: The Medcomp® Hemo-Flow® XF Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site includes the subclavian vein as required. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. HEMO-CATH® LT Indications for Use: The Medcomp® Hemo-Cath® LT Silicone Double Lumen Catheter can be utilized for long-term implantation as well as temporary access for hemodialysis, hemoperfusion or apheresis therapy. The cannula may be inserted via the Seldinger Technique due to the inner Teflon stylet, increasing linear strength. The stylet is removed after insertion, leaving the soft silicone cannula in the body. The flexible silicone make-up conforms well to the vessel anatomy, resulting in higher patient tolerance during extended use. Contraindications: The Subclavian Approach is NOT recommended for use with the Medcomp® Double Lumen Subclavian-Femoral Catheter in Hemodialysis or Hemoperfusion Procedures used for the management of acute poisoning or other situations in which a ventilator might be used due to risk of traumatic pneumothorax posing a dangerous complication for the patient. SYMETREX® Indications for Use: The Symetrex® Long Term Hemodialysis Catheter with Sideholes is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37 cm implant length are indicated for femoral placement. The Symetrex® Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37 cm implant length are indicated for femoral placement. Contraindications: Do not use this catheter in thrombosed vessels or for subclavian puncture when ventilator is in use. This device is contraindicated whenever: Used for any purpose other than indicated in these instructions. The presence of other device related infection, or septicemia is known or suspected. End caps are not intended to be punctured with a needle. Severe chronic obstructive lung disease is present. Tissue factors in the localized area of device placement will prevent proper device stabilization and/or access. Venous thrombosis or vascular surgical procedures have occurred at the prospective placement site. Post irradiation of prospective insertion site. MEDCOMP® REPAIR KIT Indications for Use: The Medcomp® Repair Kit is indicated for use in replacing damaged female luer connectors, clamps or repairing extensions where there is a minimum of 4.5cm viable extension tubing. Repairs Medcomp® Catheters: Split Cath®, Split Cath® III, Hemo-Flow®, Hemo-Flow® XF, and Titan HD Contraindications: Do not use to repair catheters other than those specified above. Do not replace connector if tubing is swollen or displays signs of degradation. This repair kit should not be used for any purpose other than indicated in these instructions. SPLIT STREAM® REPAIR KIT Indications for Use: The Medcomp® Split Stream® Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein. Catheters greater than 40CM are intended for femoral vein insertion. The Split Stream® Repair Kit is intended to repair the Split Stream® Hemodialysis catheter. Contraindications: This catheter is intended for Long-Term vascular access only and should NOT be used for any purpose other than indicated in these instructions. To maintain peak performance of the Split-Stream® extension set, it is recommended that the extension set be replaced every 6 months. TESIO® REPAIR KIT Indications for Use: The Medcomp® Tesio® Catheter is designed for Long Term Hemodialysis and Apheresis. It may be inserted percutaneously, and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian vein, the internal jugular vein is the preferred site. Contraindications: This catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. To maintain peak performance, it is recommended that this catheter be replaced after 18 months usage. To maintain peak performance of the Lock Right Adaptors, it is recommended that the adaptors be replaced every 6 months. Refer to Instructions for Use provided with the product for complete instructions, warnings, precautions, and contraindications. Observe all instructions for use prior to using products. Failure to do so may result in patient complications. Important Risk Information
RkJQdWJsaXNoZXIy MTYyNDM3Mw==