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Trio-Ct™ Triple Lumen Catheter Hemodialysis

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Trio-Ct™ Triple Lumen Catheter Hemodialysis • Laceration of Vessels or Viscus precipitation could occur. Warning: Patients requiring ventilator support are Caution: When introducer needle is used, do not assure the security of all caps and bloodline • Lumen Thrombosis at an increased risk of pneumothorax during withdraw guidewire against needle bevel to avoid connections prior to and between treatments. • Mediastinal Injury possible severing of guidewire. • Perforation of the Vessel • Do not infuse against a closed clamp or forcibly subclavian vein cannulation, which may cause complications. 19. Confirm proper tip placement with • Pleural Injury infuse a blocked catheter. 6. Remove the needle, leaving guidewire in the • Pneumothorax fluoroscopy. The distal venous tip should be TRIO-CT™ TRIPLE LUMEN CATHETER • Retroperitoneal Bleed Warning: Extended use of the subclavian vein may vessel. Enlarge cutaneous puncture site with located just before the junction of the superior • Right Atrial Puncture • To avoid damage to vessels and viscus, be associated with subclavian vein stenosis. scalpel to facilitate passage of the dilator and vena cava and the right atrium. HEMODIALYSIS, APHERESIS, AND • Risks Normally Associated with Local or General prolonged infusion pressures must not exceed catheter. INFUSION Anesthesia, Surgery, and Post-Operative Recovery 25 psi (172 kPa). • Confirm final position of catheter with chest Caution: Failure to verify catheter placement • Septicemia x-ray. Routine x-ray should always follow the 7. Thread the dilator over the proximal end of may result in serious trauma or fatal complications. • Spontaneous Catheter Tip Malposition or Retraction INSTRUCTIONS FOR USE • Subclavian only. Pinch-off Prevention: initial insertion of this catheter to confirm the guidewire. Dilate subcutaneous tissue and • Subclavian Artery Puncture CATHETER SECUREMENT AND WOUND Percutaneous insertion of the catheter must be proper tip placement prior to use. vein wall to allow easy passage of catheter into • Subcutaneous Hematoma target vein. DRESSING: INDICATIONS FOR USE: • Superior Vena Cava Puncture made into the axillary-subclavian vein at the junction of the outer and mid-third of the • Thoracic Duct Laceration DIRECTIONS FOR SELDINGER INSERTION 20. Suture the catheter to the skin using the • Vascular Thrombosis clavicle lateral to the thoracic outlet. The Caution: Insufficient tissue dilation can • The Trio-CT™ Triple Lumen Catheter is suture wing. Removable suture wing may be indicated for use in attaining short-term catheter must not be inserted into the cause compression of the catheter lumen • Read instructions carefully before using this used to minimize movement at exit site. Do (less than 30 days) vascular access for • Before attempting the insertion, ensure that subclavian vein medially, because such against the guidewire causing difficulty in the device. The catheter should be inserted, not suture the catheter tubing. hemodialysis and apheresis. The third internal you are familiar with the potential placement can lead to compression of the insertion and removal of the guidewire from manipulated, and removed by a qualified, lumen is intended for infusion, power injection complications and their emergency treatment catheter between the first rib and clavicle the catheter. This can lead to bending of the licensed physician or other qualified health Caution: Care must be taken when using sharp of contrast media and central venous pressure should any of them occur. and can lead to damage or fracture and guidewire. care professional under the direction of a objects or needles in close proximity to catheter monitoring. embolization of the catheter. Fluoroscopic or physician. The medical techniques and lumen. Contact from sharp objects may cause WARNINGS: radiographic confirmation of catheter tip 8. Remove the dilator leaving the guidewire in procedures described in these instructions catheter failure. • The catheter is intended to be inserted in the placement can be helpful in demonstrating place. for use do not represent all medically jugular, femoral or subclavian vein as required. • In the rare event that a hub or connector that the catheter is not being pinched by the acceptable protocols, nor are they intended as Caution: Do not leave vessel dilator in place as an 21. Cover the insertion site with an occlusive The maximum recommended infusion rate is separates from any component during first rib and clavicle.1 indwelling catheter to avoid possible vessel wall dressing leaving extensions, clamps, luers, and 5ml/sec for power injection of contrast media. insertion or use, take all necessary steps a substitute for the physician’s experience and caps exposed for access by the staff. and precautions to prevent blood loss or • Catheters should be implanted carefully to judgment in treating any specific patient. Use perforation. DESCRIPTION: air embolism and remove the catheter. avoid any sharp or acute angles which could standard hospital protocols when applicable. 9. Irrigate catheter with saline, then clamp 22. Catheter must be secured/sutured for entire compromise the opening of the catheter catheter extensions to assure that saline is • The Trio-CT™ Triple Lumen Catheter is a • Do not advance the guidewire or catheter if 1. Strict aseptic technique must be used during duration of implantation. lumens. not inadvertently drained from catheter. Use short-term (less than 30 days) dialysis catheter unusual resistance is encountered. insertion, maintenance, and catheter removal procedures. Provide a sterile operative field. clamps provided. 23. Record catheter length and catheter lot number made of thermosensitive polyurethane. The • Recirculation in fermoral catheters was • Do not insert or withdraw the guidewire The Operating Room is the preferred location on patient’s chart. catheter has three separate lumens allowing reportedly significantly greater than in internal Caution: Do not clamp the lumen portion of the forcibly from any component. The wire may 5 for catheter placement. Use sterile drapes, continuous blood flow. The venous (blue) and jugular catheters. catheter. Clamp only the extensions. Do not use break or unravel. If the guidewire becomes instruments, and accessories. Shave the skin HEMODIALYSIS TREATMENT arterial (red) lumens may be used for serrated forceps, use only the in-line clamps hemodialysis and apheresis treatments. The damaged, the catheter and guidewire must be • Cannulation of the left internal jugular vein above and below the insertion site. Perform provided. • middle (purple) lumen is independent from the removed together. was reportedly associated with a higher surgical scrub. Wear gown, cap, gloves, and The anticoagulant locking solution must be mask. Have patient wear mask. removed from the arterial and venous lumens two dialysis lumens, and may be used for incidence of complications compared to 10. Open distal extension clamp. Thread the • Federal law (USA) restricts this device to sale prior to treatment. Aspiration should be based intravenous therapy, power injection of catheter placement in the right internal jugular catheter over proximal end of the guidewire. contrast media, central venous pressure by or on the order of a physician. vein.2 2. The selection of the appropriate catheter length on dialysis unit protocol. monitoring, blood draws and infusion of is at the sole discretion of the physician. To 11. Ease the catheter through the subcutaneous • This catheter is for Single Use Only. achieve proper tip placement, proper catheter • Before dialysis begins, all connections to medications. The attachable suture wing can • Discard Biohazard according to facility tissue and into the target vein. length selection is important. Routine x-ray catheter and extracorporeal circuits should be be used to provide additional catheter protocol. examined carefully. securement and to minimize movement at the • Do not resterilize the catheter or accessories by should always follow the initial insertion Caution: Observe the patient carefully for signs and of this catheter to confirm proper placement symptoms of cardiac arrhythmia caused by passage exit site. any method. INSERTION SITES: • prior to use. of the catheter into the right atrium. If symptoms Frequent visual inspection should be conducted to detect leaks to prevent blood loss or air CONTRAINDICATIONS: • Re-use may lead to infection or illness/injury. Caution: Left sided placement in particular, may appear, pull back the tip of the catheter until they provide unique challenges due to the right angles Tip Placement are eliminated. embolism. • The manufacturer shall not be liable for any formed by the innominate vein and the left • This catheter is intended for short-term (less • If a leak is found, the catheter should be damages caused by re-use or resterilization of brachiocephalic junction with the left SVC.3,4 than 30 days) vascular access only and should 12. Make any adjustments to catheter under clamped immediately. not be used for any purpose other than this catheter or accessories. fluoroscopy. The distal tip should be located indicated in these instructions. • The patient should be in a modified just before the junction of the superior vena Caution: Only clamp catheter with in-line clamps • Contents sterile and non-pyrogenic in Trendelenberg position, with the upper cava and the right atrium. provided. This device is also contraindicated: unopened, undamaged package. STERILIZED chest exposed and the head turned slightly to the side opposite the insertion area. A small 13.
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