Bard Power-Trialysis, Инструкция по эксплуатации, Страница: 4 / 10

Warnings
(cont.)
• To avoid damage to vessels and viscus, prolonged infusion pressures must not exceed 25 psi (172 kPa). The use of a 10 mL or larger
syringe is recommended because smaller syringes generate more pressure than larger syringes.
NOTE: A three pound (13.3 Newton) force on the plunger of a 3 mL syringe generates pressure in excess of 30 psi (206 kPa) whereas the
same three pound (13.3 Newton) force on the plunger of a 10 mL syringe generates less than 15 psi (103 kPa) of pressure.
• Accessories and components used in conjunction with this catheter must incorporate Luer-lock adapters in order to avoid inadvertent
disconnection.
• Catheters should be implanted carefully to avoid any sharp or acute angles which could compromise the opening of the catheter lumens.
• Before dialysis begins, all connections to the extracorporeal circuit must be checked carefully. During all dialysis procedures frequent
visual inspection must be conducted to detect leaks and prevent blood loss or entry of air into the extracorporeal circuit. Excess blood
leakage may lead to patient shock.
• In the rare event of a leak, the catheter must be clamped immediately. Necessary remedial action must be taken prior to resuming dialysis
procedure.
• If the catheter is not used immediately for treatment, follow the suggested Catheter Patency Guidelines.
• Failure to clamp extensions when not in use may lead to air embolism.
• Verification of the catheter tip location must be confirmed by x-ray to ensure proper placement.
• To prevent systemic heparinization of the patient, the heparin solution must be aspirated out of the lumens immediately prior to using
the catheter.
• For jugular and subclavian insertion, the patient must be placed on a cardiac monitor during this procedure. Cardiac arrhythmia may
result if the guidewire is allowed to pass into the right atrium. The guidewire must be held securely during the procedure.
• The risk of infection is increased with femoral vein insertion.
• Recirculation in femoral catheters was reportedly significantly greater than in internal jugular catheters.
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• Before attempting the insertion of the catheter, ensure that you are familiar with the possible complications listed below and their emer-
gency treatment should they occur.
• Cannulation of the left internal jugular vein was reportedly associated with a higher incidence of complications compared to catheter
placement in the right internal jugular vein.
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• Failure to warm contrast media to body temperature (37°C) prior to power injection may result in catheter failure
• Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.
• Do not use lumens not marked “Power Injectable” for power injection of contrast media.
• Power injection machine pressure limiting feature may not prevent over-pressurization of an occluded catheter, which may lead to cath-
eter failure.
• Exceeding the maximum flow rate of 5 mL/sec or the maximum pressure of power injectors of 300 psi may result in catheter failure and/
or catheter tip displacement.
• Catheter indication for power injection of contrast media implies the catheter’s ability to withstand the procedure, but does not imply
appropriateness of the procedure for a particular patient. A suitably trained clinician is responsible for evaluating the health status of a
patient as it pertains to a power injection procedure.
• Do not power inject through a catheter that exhibits signs of clavicle-first rib compression or pinch-off, as it may result in catheter failure.
• If local pain, swelling, or signs of extravasation are noted, the injection should be stopped immediately.
• After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical practice and applicable
local, state and federal laws and regulations.
• CVP Monitoring should always be used in conjunction with other patient assessment metrics when evaluating cardiac function.
• CVP Monitoring should not be performed during hemodialysis, hemoperfusion or apheresis.
• For optimal product performance and to avoid complications, do not insert any portion of the curve into the vein.
Cautions
• Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
• Carefully read and follow all instructions prior to use.
• Only qualified health care practitioners should insert, manipulate, and remove these devices.
• Strict aseptic technique must be used during the insertion, maintenance, and catheter removal procedures.
• Do not pull back guidewire over needle bevel as this may sever the end of the guidewire. The introducer needle must be removed first.
Also, if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the cause of resis-
tance before proceeding. Withdraw needle and guidewire if cause of resistance cannot be determined.
• Do not allow the guidewire to inadvertently advance totally into the vessel.
• For jugular and subclavian insertion, the catheter tip should not be located in the right atrium.
• Sterile, non-pyrogenic unless package is damaged or opened.
• Left sided placement in particular, may provide unique challenges due to the right angles formed by the innominate vein and at the
left brachiocephalic junction with the left SVC. 3
• Follow all contraindications, warnings, precautions, and instructions for all infusates, including contrast media, as specified by their
manufacturer.
• In vitro flow data indicates flow rates above 350 mL/min for Alphacurve™ Catheter configurations may exceed -250 mmHg prepump
pressure as per K/DOQ1 (2006) guidelines.