The PowerPICC* catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

• Contrast media should be warmed to body temperature prior to power injection.
  Warning: Failure to warm contrast media to body temperature prior to power injection may result in catheter failure.
• Vigorously flush the PowerPICC* catheter using a 10 ml or larger syringe and sterile normal saline prior to and immediately following the completion of power injection studies. In addition, lock each lumen of the catheter with heparinized saline. Usually one ml per lumen is adequate. This will ensure the patency of the PowerPICC* catheter and prevent damage to the catheter. Resistance to flushing may indicate partial or complete catheter occlusion. Do not proceed with power injection study until occlusion has been cleared.
  Warning: Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.
• Use only lumens marked "Power Injectable" for power injection of contrast media.
  Warning: Use of lumens not marked "Power Injectable" for power injection of contrast media may cause failure of the catheter.
• Do not exceed the maximum flow rate of 5 ml/sec.
  Warning: Power injector machine pressure limiting feature may not prevent over-pressurization of an occluded catheter, which may lead to catheter failure.
  Warning: 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.
• Warning: PowerPICC* 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.

1. Remove the injection/needleless cap from the PowerPICC* catheter.
2. Attach a 10 ml or larger syringe filled with sterile normal saline.
3. Aspirate for adequate blood return and vigorously flush the catheter with the full 10 ml of sterile normal saline.
   Warning: Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.
4. Detach syringe.
5. Attach the power injection device to the PowerPICC* catheter per manufacturer’s recommendations.
6. Contrast media should be warmed to body temperature prior to power injection.
   Warning: Failure to warm contrast media to body temperature prior to power injection may result in catheter failure.
7. Use only lumens marked "Power Injectable" for power injection of contrast media.
   Warning: Use of lumens not marked "Power Injectable" for power injection of contrast media may cause failure of the catheter.
8. Complete power injection study taking care not to exceed the flow rate limits. Do not exceed the maximum flow rate of 5 ml/sec.
   Warning: Power injector machine pressure limiting feature may not prevent over-pressurization of an occluded catheter, which may lead to catheter failure.
   Warning: 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.
9. Disconnect the power injection device.
10. Replace the injection/needleless cap on the PowerPICC* catheter.
11. Flush the PowerPICC* catheter with 10 ml of sterile normal saline, using a 10 ml or larger syringe. In addition, lock each lumen of the catheter with heparinized saline. Usually one ml per lumen is adequate.

The device is contraindicated whenever:

1. The presence of device related infection, bacteremia, or septicemia is known or suspected.
2. The patient’s body size is insufficient to accommodate the size of the implanted device.
3. The patient is known or is suspected to be allergic to materials contained in the device.
4. There has been past irradiation of prospective insertion site.
5. There have been previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
6. There are local tissue factors that may prevent proper device stabilization and/or access.

• When using alcohol or alcohol containing antiseptics with polyurethane PICCs, care should be taken to avoid prolonged or excessive contact. Solutions should be allowed to completely dry before applying an occlusive dressing. Chlorhexidine gluconate and/or povidone iodine are the suggested antiseptics to use.
• Alcohol should not be used to lock, soak or declot polyurethane PICCs because alcohol is known to degrade polyurethane catheters over time with repeated and prolonged exposure.
• Acetone and polyethylene glycol containing ointments should not be used with polyurethane catheters, as these may cause failure of the device.
• This is not a right atrium catheter. Avoid positioning the catheter tip in the right atrium. Placement or migration of the catheter tip into the right atrium may cause cardiac arrhythmia, myocardial erosion or cardiac tamponade. The risk of these complications may be more likely in neonatal patients.
• Intended for Single Patient Use. DO NOT REUSE. Bard Access Systems products are single use devices and should never be reimplanted. Reuse carries with it the attendant concern of cross-infection regardless of the cleaning or sterilization method. Resterilization of incompletely cleaned devices may not be effective. Any device that has been contaminated by blood must not be reused or resterilized.
• 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.
• Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.
• Use of lumens not marked "Power Injectable" for power injection of contrast media may cause failure of the catheter.
• Power injector machine pressure limiting feature may not prevent over-pressurization of an occluded catheter, which may cause catheter failure.
• Exceeding the maximum flow rate of 5 ml/sec, and the maximum pressure of power injectors of 300 psi (2068kPa), may result in catheter failure and/or catheter tip displacement.
• PowerPICC* 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.
• If the artery is entered, withdraw the needle and apply manual pressure for the several minutes.
• Place a finger over the orifice of the sheath to minimize blood loss and risk of air aspiration. The risk of air embolism is reduced by performing this part of the procedure with the patient performing the Valsalva maneuver until the catheter is inserted into the sheath.
• Do not use the catheter if there is any evidence of mechanical damage or leaking. Damage to the catheter may lead to rupture, fragmentation, possible embolism, and surgical removal.
• If signs of extravasation exist, discontinue injections. Begin appropriate medical intervention immediately.
• The fluid level in the catheter will drop if the catheter connector is held above the level of the patient’s heart and opened to air. To help prevent a drop in the fluid level (allowing air entry) while changing injection caps, hold the connector below the level of the patient’s heart before removing the injection cap.
• Central venous pressure monitoring should always be used in conjunction with other patient assessment metrics when evaluating cardiac function.

Precautions:

• Carefully read and follow all instructions prior to use.
• Follow Universal Precautions when inserting and maintaining the catheter.
• Follow all contraindications, warnings, cautions, precautions and instructions for all infusates, including contrast media, as specified by their manufacturer.
• Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
• Only medical practitioners licensed by law, trained and experienced in proper positioning of catheters in the central venous system using percutaneous entry (Seldinger technique) should place this catheter.
• Only qualified health care practitioners should insert, manipulate and remove these devices.
• The PowerPICC* catheter features a reverse-taper catheter design. Placement of larger catheters at or below antecubital fossa may result in an increased incidence of phlebitis. Placement of the PowerPICC* catheter above antecubital fossa is recommended.
• Never use force to remove the stylet. Resistance can damage the catheter. If resistance or bunching of the catheter is observed, stop stylet withdrawal and allow the catheter to return to normal shape. Withdraw both the catheter and stylet together approximately 2 cm and reattempt stylet removal. Repeat this procedure until the stylet is easily removed. Once the stylet is out, advance the catheter into the desired position (zero mark).
• When trimming the catheter, do not cut stylet.
• Avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.
• Placement of larger catheters at or below antecubital fossa may result in an increased incidence of phlebitis. Placement of PICC above antecubital fossa is recommended.
• If the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.
• Use aseptic techniques whenever the catheter lumen is opened or connected to other devices.
• Do not advance the guidewire past the axilla without fluoroscopic guidance.
• The catheter must be secured in place to minimize the risk of catheter breakage and embolization.

I. Prior to beginning placement procedure, do the following:

• Examine the package carefully before opening to confirm its integrity and that the expiration date has not passed. The device is supplied in a sterile package and is non-pyrogenic. Do not use if package is damaged, opened or the expiration date has passed. Sterilized by ethylene oxide. Do not resterilize.
• Inspect kit for inclusion of all components.
• Flush the catheter with sterile normal saline prior to use. Catheter stylet must be wetted prior to stylet repositioning or withdrawal.

II. To avert device damage and/or patient injury during placement:

• Do not allow accidental device contact with sharp instruments. Mechanical damage may occur. Use only smooth edged, atraumatic clamps or forceps.
• Do not perforate, tear, or fracture the catheter when using a guidewire.
• Do not use the catheter if there is any evidence of mechanical damage or leaking.
• Do not bend catheter at sharp angles during implantation. This can compromise catheter patency.
• Do not occlude or cut catheter when using sutures to secure catheter.
• When using peel-apart introducers:
• Avoid blood vessel damage by maintaining a catheter or dilator as internal support when using a peel-apart introducer.
• Avoid sheath damage by simultaneously advancing the sheath and dilator as a single unit using a rotational motion.
• Do not suture around the catheter as sutures may damage the catheter or compromise catheter patency.
• Do not cut stylet.

III. After placement, observe the following precautions to avoid device damage and/or patient injury:

• Warning: Do not use the device if there is any evidence of mechanical damage or leaking. Damage to the catheter may lead to rupture, fragmentation and possible embolism and surgical removal.
• Accessories and components used in conjunction with this device should incorporate luer lock connections.
• Warning: If signs of extravasation exist, discontinue injections. Begin appropriate medical intervention immediately.
• DO NOT USE A SYRINGE SMALLER THAN 10 ml. Prolonged infusion pressure greater than 25 psi may damage blood vessels or viscus.
• Warning: Exceeding the maximum flow rate of 5 ml/sec may result in catheter failure and/or catheter tip displacement.
• For further information or questions, please call 800-443-3385 or 801-595-0700.

• Physician Insertion Instructions
• Nursing Insertion Instructions