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`Attachment A
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`Bard Exhibit 1018 Page 7 of 8
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`MC-0055-01 CT Wallchart.qxd 3/13/07 4:53 PM Page 1
`
`Guidelines for
`CT Technologists
`
`IDENTIFYING A PATIENT WITH THE POWERPORT* IMPLANTED PORT
`
`• Check patient’s chart for a PowerPort* device patient record sticker.
`• Palpate top of port to identify three palpation points (bumps) on
`the septum, arranged in a triangle.
`• Palpate the sides of the port to identify triangular port housing.
`• Ask the patient. Patients with a PowerPort* implanted port should have
`a patient identification card, ID bracelet or key ring to help remind them
`they have a PowerPort* device.
`• Always verify the patient has a PowerPort* device by at least two
`means, and ensure it is accessed with a PowerLoc* Safety Infusion Set,
`prior to power injection.
`
`3 Palpation Points
`(bumps) on Septum
`
`ChronoFlex®
`Polyurethane Catheter
`
`PowerLoc* Safety Infusion Set (SIS)
`
`PowerPort*
`Verification Tag
`
`PowerPort* Implantable Port
`
`Check patient chart
`
`Feel for bumps on septum Feel for triangle shape
`
`Ask your patient
`
`Double Check
`
`POWER INJECTION
`
`Power Injection Procedure:
`
`1. Access the port with a PowerLoc*
`Safety Infusion Set. Make certain that
`needle tip is inserted fully within the
`port. Warning: The PowerPort*
`system is only power injectable when
`accessed with a PowerLoc* Safety
`Infusion Set. Note: Follow institutional
`protocol to verify correct catheter tip
`position prior to power injection.
`2. Attach a syringe filled with sterile
`normal saline.
`Instruct the patient to assume the
`position they will be in during the
`power injection procedure, before
`checking for patency. If possible, the
`patient should receive power injection
`with his or her arm vertically above
`the shoulder with the palm of the
`hand on the face of the gantry during
`
`3.
`
`USE AND MAINTENANCE
`
`ACCESSING IMPLANTED PORTS
`
`Procedure:
`1. Perform aseptic site preparation.
`2. Locate port septum by palpation.
`a. Locate base of port with
`non-dominant hand.
`b. Triangulate port between thumb and
`first two fingers of non-dominant
`hand. Aim for center point of these
`three fingers.
`
`injection. This allows for uninterrupted
`passage of injected contrast through
`the axillary and subclavian veins at
`the thoracic outlet.
`4. Aspirate for adequate blood return
`and vigorously flush the port with
`at least 10 ml of sterile normal
`saline. Warning: Failure to ensure
`patency of the catheter prior to
`power injection studies may result
`in port system failure.
`5. Detach syringe.
`6. Warm contrast media to body
`temperature.
`7. Attach the power injection device to
`the PowerLoc* Infusion Set ensuring
`PowerLoc* Safety Infusion Set Gauge Size
`PowerLoc* Safety Infusion Set Wing Color
`Max. Flow Rate Setting
`
`8.
`
`9.
`
`connection is secure. Check indicated
`flow rate of safety infusion set and
`confirm CT settings.
`Instruct the patient to communicate
`immediately any pain or change in
`feeling during the injection.
`Inject warmed contrast, taking care not
`to exceed the flow rate limits. Warning:
`If local pain, swelling or signs of
`extravasation are noted, the injec-
`tion should be stopped immediately.
`Warning: Exceeding the maximum
`flow rate may result in port system fail-
`ure and/or catheter tip displacement.
`10. Disconnect the power injection device.
`11. Flush the PowerPort* device with 10
`ml of sterile normal saline.
`19 Ga.
`20 Ga.
`Cream
`Yellow
`5 ml/s
`5 ml/s
`
`22 Ga.
`Black
`2 ml/s
`
`4. Confirm correct positioning of the needle
`within the port reservoir by aspiration of
`blood (“flashback”). If there is doubt
`regarding proper needle placement,
`have a radiographic dye procedure done
`to confirm placement.
`5. Always flush the port following
`injection.
`6. Perform heparin lock procedure.
`Remember that some patients may be
`hypersensitive to heparin or suffer from
`heparin induced thrombocytopenia (HIT)
`and these patients must not have their
`port locked with heparinized saline.
`7. When deaccessing the port, flush per
`institutional protocol. Close clamp
`while injecting the last 0.5ml of flush
`solution.
`
`hypersensitive to heparin or suffer from
`heparin induced thrombocytopenia (HIT)
`and these patients must not have their
`port locked with heparinized saline.
`Determine Port Volume:
`
`For PowerPort* implanted ports, you will need
`to check the patient’s chart to determine the
`length of catheter used for each individual
`patient. For 8 Fr. polyurethane catheters, multi-
`ply the catheter length in cm by 0.02 ml, then
`add 0.60 ml for the port reservoir:
`Example:
`Catheter length: _________ cm x 0.02 ml/cm
`+0.6 ml (port reservoir) = _________ ml
`volume, total priming volume for patient
`port and catheter.
`
`Recommended Flushing Volumes:
`
`3. Insert PowerLoc* Safety Infusion Set
`perpendicular to port septum. Advance
`needle through the skin and septum
`until reaching bottom of reservoir.
`
`FLUSHING VOLUMES
`Procedure
`Volume (100 U/ml)
` _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
`When port not
`5 ml heparinized saline
`in use
`every 4 weeks
` _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
`After each infusion
`10 ml sterile normal
`of medication or TPN saline, then 5 ml
`heparinized saline
` _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
`20 ml sterile normal
`After blood
`withdrawal
`saline, then 5 ml
`heparinized saline
` _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
`10 ml sterile normal
`After power
`injection of
`saline, then 5 ml
`contrast media
`heparinized saline
`
`12. Perform heparin lock procedure.
`Remember that some patients may be
`hypersensitive to heparin or suffer hep-
`arin induced thrombocytopenia (HIT).
`These patients must not have their port
`primed with heparinized saline.
`13. After therapy completion, flush
`port per institutional protocol. Close
`clamp while injecting last 0.5 ml of
`flush solution.
`14. Pull PowerLoc* Safety Infusion Set
`top wings away from the lower wings
`until you feel a "click" at which time
`the needle should be captured within
`PowerLoc's safety mechanism.
`Warning: Do not exceed a 300 psi
`pressure limit setting, or the maxi-
`mum flow rate setting shown at left,
`on the power injection machine if
`power injecting through the
`PowerPort* device.
`
`Procedure:
`Review Site Preparation in the PowerPort*
`Nursing Guide, and Accessing Implanted
`Ports section before proceeding with the
`following:
`
`1. Explain procedure to patient and
`prepare injection site.
`2. Attach a syringe filled with sterile
`normal saline to needle.
`3. Aseptically locate and access port
`with PowerLoc* Safety Infusion Set,
`or other non-coring safety needle.
`Confirm correct positioning of the
`needle within the port reservoir by
`aspiration of blood (“flashback”).
`If there is doubt regarding proper
`needle placement, have a radio-
`graphic dye procedure done to
`confirm placement.
`4. Flush the system.
`5. When deaccessing the port, flush per
`institutional protocol. Close clamp
`while injecting the last 0.5ml of flush
`solution.
`
`SEE POWERPORT*
`CT GUIDE FOR
`MORE DETAILS.
`
`Feel the NEW
`Standard of Care*
`Indications For Use
`The PowerPort* implanted port is indicated for patient
`therapies requiring repeated access to the vascular system.
`The port system can be used for infusion of medications,
`I.V. fluids, parenteral nutrition solutions, blood products,
`and for the withdrawal of blood samples.
`When used with the PowerLoc* Safety Infusion Set, the
`PowerPort* device is indicated for power injection of
`contrast media. For power injection of contrast media,
`the maximum recommended infusion rate is 5 ml/s.
`This device is contraindicated for catheter insertion in the
`subclavian vein medial to the border of the first rib, an
`area which is associated with higher rates of pinch-off.
`All materials are biocompatible, can be used with
`virtually all injectable solutions, are latex-free, and are
`safe with CECT and MRI imaging up to 3 Tesla (3T).
`
`PowerPort*- Titanium
`Device
`
`PowerPort*- M.R.I.*
`Device
`
`PowerPort*- Titanium Device
`
`PowerPort*- M.R.I* Device
`
`Non-Flipped Port Flipped Port
`
`IMPORTANT INFORMATION:
`• A PowerLoc* Safety Infusion Set MUST always
`be used to access the PowerPort* implanted
`port for power injecting contrast media.
`
`• Contrast media should be warmed to body temperature
`prior to power injection. Warning: Failure to warm con-
`trast media to body temperature prior to power injection
`may result in port system failure.
`• Check for blood return, then flush the PowerPort* device
`using at least 10 ml of sterile normal saline prior to and
`immediately following the completion of power injection
`studies. Always ensure the patency of the PowerPort*
`device to prevent damage to the port system. Resistance to
`flushing may indicate 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 port system failure.
`
`Maximum Flow Rates and Pressure
`
`PowerLoc* Safety Infusion
`Set Gauge Size
`PowerLoc* Safety Infusion
`Set Wing Color
`Maximum Flow Rate Setting
`Maximum Pressure Setting
`
`19 Ga.
`
`20 Ga.
`
`22 Ga.
`
`Cream
`5 ml/s
`
`Black
`2 ml/s
`
`Yellow
`5 ml/s
`300 psi
`
`• Do not exceed a 300 psi pressure limit setting, or the maximum
`flow rate setting shown above, on the power injection machine
`if power injecting through the PowerPort* device. Warning:
`Exceeding the maximum flow rate may result in port system
`failure and/or catheter tip displacement. Warning: If local
`pain, swelling or signs of extravasation are noted, the injection
`should be stopped immediately.
`
`HEPARIN LOCK
`To help prevent clot formation and catheter
`blockage, implanted ports with open-ended
`catheters should be flushed with 10 ml
`sterile normal saline using a turbulent
`push-pause flushing method after each use
`followed by 5 ml of heparinized saline.
`Clamp the tubing while infusing the last
`0.5 ml of fluid to reduce potential for blood
`back-flow into the catheter tip, which could
`encourage catheter clotting. If the port
`remains unused for long periods of time,
`the 5 ml heparin solution should be
`changed at least every four weeks.
`Remember that some patients may be
`Please consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use.
`
`Bard Access Systems, Inc.
`Salt Lake City, UT 84116 USA 801-595-0700
`Clinical Information Hotline: 800-443-3385
`Ordering Information: 800-545-0890
`www.bardaccess.com • www.portadvantage.com
`www.powerportadvantage.com
`
`An issued or revision date for these instructions is included for the user’s information. In the event two years have elapsed between this date and product use, the user should contact Bard Access
`Systems, Inc. to see if additional product information is available.
`* Bard, PowerPort, PowerLoc, “Feel the New Standard of Care”, M.R.I. and the color purple are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate. ChronoFlex is a registered
`trademark of CardioTech International, Inc. U.S. patents pending. © Copyright 2007 C. R. Bard, Inc. All rights reserved. Revised date: February 2007
`
`LATEX-FREE
`
`MC-0055-01 0702R
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`Bard Exhibit 1004 Page 1 of 1
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`Bard Exhibit 1018 Page 8 of 8