Central Venous Catheters - BD...Central Venous Catheters Instructions For Use PowerHohn* Central Venous Catheter Placement Procedure 1. The procedure is performed using sterile surgical

Bard Access Systems

Central Venous CathetersInstructions For Use

PowerHohn* Central Venous Catheter Placement Procedure1. The procedure is performed using sterile surgical technique including the use of gloves,

masks, gowns, and sterile drapes and equipment throughout all steps listed below.2. Place the patient in the Trendelenburg position. Prep the insertion site using standard

surgical technique.3. The subclavian veins and the internal and external jugular veins are the most common

vessels used for catheter insertion. The femoral vein may also be used.4. Administer local anesthesia at the venous entry site, the underlying subcutaneous tissue,

and where the wing will be sutured or the StatLock* device secured.5. Catheters can be cut to length if a different length is desired due to patient size and

desired point of insertion. 6. Enter the vein chosen for insertion of the catheter using the introducer needle and

syringe or sheath over the needle. (Refer to figure 2)Caution: When inserting the catheter via a subclavian approach, maintain a horizontaltrajectory when introducing the needle beneath the clavicle. Vertical needle passage mayincrease the risk of pneumothorax. Refer to “Warnings” section concerning Catheter Pinch-off.

7. Aspirate gently as the needle is introduced. Warning: If the artery is entered, withdrawthe needle and apply manual pressure for several minutes. If the pleural space is entered,withdraw needle and observe patient for signs of pneumothorax. (Refer to figure 3)

8. When the vein has been entered, remove the syringe leaving the needle in place. If usingthe sheath over the needle, insert the assembly and withdraw the needle and syringeleaving the sheath indwelling. Place a finger over the needle or sheath hub to minimizeblood loss and risk of air aspiration. The risk of air aspiration is reduced by performingthis part of the procedure with the patient performing the Valsalva maneuver. (Refer tofigure 4)

9. Insert tapered end of the tip straightener into the needle (or sheath). Advance theguidewire to the superior vena cava. (Refer to figure 5)Caution: To help avoid possible severing of the guidewire, do not withdraw the guidewireback against the needle bevel.

10. Withdraw and remove needle (or sheath) while holding the guidewire in place. Maintainslight pressure on the puncture site after the needle is withdrawn. (Refer to figure 6)

10a. For catheters with VitaCuff* antimicrobial cuff: use the supplied scalpel, if needed, to makea skin nick at the insertion site to accommodate the antimicrobial cuff. (Refer to figure 7)

11. A skin nick may be made adjacent to the insertion site to facilitate tip insertion.12. Advance the dilator over the exposed wire using a rotational motion to develop a tunnel

for the catheter. Gentle counter traction on the skin may facilitate smooth passage of thedilator. Several passes with the dilator are recommended. (Refer to figure 8)

13. Withdraw the dilator.Note: Patients with thick muscular chest walls or extensive scar tissue may require theuse of a percutaneous introducer for catheter insertion.

14. For the dual lumen catheter, clamp and attach an end cap to the one luer adapter toavoid possible air embolus.

15. Thread the catheter over the guidewire and advance the catheter to the insertion site.The guidewire must extend out from the luer adapter.

16. Advance the catheter and wire assembly together as a unit with a rotational motion. Thisis best accomplished by gently squeezing the catheter against the wire and rotating dur-ing advancement until the catheter is fully inserted. Gentle counter traction on the skinmay also facilitate smooth catheter passage. (Refer to figure 9)Caution: Do not attempt to slide the catheter over the wire separately into the vein. Thismay cause the catheter to bunch up on the wire making advancement of the catheter intothe vessel more difficult.

17. To help prevent advancement of the wire into the right atrium during insertion, pause atleast twice and pull the wire back while stabilizing the catheter. Then continue to advancethe catheter and wire assembly together as a unit until the catheter is completely inserted.

18. When the catheter has been inserted, hold it firmly in position and slowly withdraw theguidewire. Have the patient perform the Valsalva maneuver as the end of the wire iswithdrawn, and then clamp the catheter. (Refer to figure 10)

19. Check for blood return. Then flush the lumen(s) with heparin solution or normal salineand attach end cap.

20. Suture the catheter in place by passing the suture through the eyes of the cathetersuture wing. Place the ties in the direction of the insertion site to help prevent cathetermigration. Tie with at least four throws. (Refer to figure 11) Alternatively, the suture wing may be fixed to the patient with aStatLock* device.

21. Cleanse and dress insertion site according to approved technique. (Refer to figure 12)22. Obtain a chest x-ray to confirm correct catheter position and absence of pneumothorax.Note: The PowerHohn* catheter testing included 10 power injection cycles.

Tunneling Procedure (If Applicable)

1. Measure catheter against chest wall or upper arm of patient to determine desired location of VitaCuff* Antimicrobial Cuff andexit site. Mark locations, or make a skin nick at insertion site to accommodate the VitaCuff* Antimicrobial Cuff.

2. Tunneling procedure. Note: The VitaCuff* Antimicrobial Cuff should be positioned in the tunnel. The cuff will be less promi-nent if positioned over an intercostal space. Create subcutaneous tunnel from skin exit site to venous entrance using tunneler or long forceps.a. Grasp the tunneler at the end.b. Insert the rounded tip of the tunneler into a small incision at the desired catheter exit.c. Form tunnel by advancing the tip of the tunneler from the skin exit site up to the venous entry site. Caution: Avoid inadver-

tent puncture of the skin or fascia with the tip of the tunneler.d. Attach the lumen tip or one of the lumen tips of the dual lumen catheter onto the tunneler

barb with a twisting motion. Barb threads must be completely covered by the catheter tip toadequately secure the catheter as it is pulled through the tunnel. A suture may be tiedaround the catheter between the tunneler body and large barb to hold it more securely.

e. Pull the catheter up through the tunnel to the venous entry site. (Initial resistance may bemet as the VitaCuff* Antimicrobial Cuff first enters the tunnel.) Gently holding the catheterproximal to the cuff while pulling the tunneler and catheter through the subcutaneous tunnelshould result in smooth passage of the cuff into the subcutaneous tunnel. Caution: Whentunneling, the catheter must not be forced.

f. Remove the catheter tip from the tunneler barb. Cutoff the end tied by suture.

Catheter Exchange1. Any damaged, ruptured, or leaking catheter must be replaced immediately to prevent blood loss and/or air embolus. The

catheter should be clamped proximal to the damaged area close to the chest wall.2. The catheter exchange technique is designed to replace an indwelling PowerHohn* central venous catheter with a new

catheter, using the existing venous entry site. Establish a full sterile field and use mask and gloves.3. Insert the guidewire through the indwelling catheter and remove the indwelling catheter by pulling it back over the wire.4. Advance the new catheter over the wire as instructed in the previous section, and remove the guidewire.5. Suture the new catheter in place through the eyes of the suture wing. Alternatively, the suture wing may be fixed to the

patient with a StatLock* device. Cover with a sterile dressing according to approved technique.

FlushingFlushing frequencies from once daily to once weekly have been found to be effective when the catheter is not in use. Flush withheparin after IV administration of TPN, IV fluids, or after medications.Note: For frequently accessed catheters (accessed at least every 8 hours), flushing with 5 ml of normal saline without heparinbetween infusions has been found to be effective.

References1. Aitken, D.R. and Minton, J.P. “The Pinch-Off Sign: A Subclavian Catheters”, American Journal of Surgery, Vol. 148, Nov. 1984,

pp. 633-636.2. Rubenstein, R.B., Alberty, R.E., et al. “Hickman* Catheter Separation”, JPEN, Vol. 9, No. 6, Nov./Dec. 1985, pp. 754-757.3. Hinke, D.H.; Zandt-Stastny, D.A.; Goodman, L.R.; et al. Pinch-off syndrome: A complication of implantable subclavian venous

access devices. Radiology 177: 353-356, 1990.4. Ingle, Rebecca,; Nace, Corinne, Venous Access Devices: Catheter Pinch-off and Fracture, 1993, Bard Access Systems, Inc.

Bard Access Systems, Inc. warrants to the first purchaser of this product that this product will be free from defects in materials andworkmanship for a period of one year from the date of first purchase and liability under this limited product warranty will be limited torepair or replacement of the defective product, in Bard Access Systems, Inc. sole discretion or refunding your net price paid. Wearand tear from normal use or defects resulting from misuse of this product are not covered by this limited warranty.

TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHERWARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MER-CHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL BARD ACCESS SYSTEMS, INC. BELIABLE TO YOU FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING OR USE OFTHIS PRODUCT.

Some states/countries do not allow an exclusion of implied warranties, incidental or consequential damages. You may be entitledto additional remedies under the laws of your state/country.

An issued or revision date for these instructions is included for the user’s information. In the event two years have elapsedbetween this date and product use, the user should contact Bard Access Systems, Inc. to see if additional product information isavailable.

Revised Date: February, 2007

*Bard, Hickman, Hohn, PowerHohn and StatLock are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate. *VitaCuff and VitaGuard are registered trademarks of Integra LifeSciences, Corporation.

U.S. Patent Pending.

Bard Access Systems, Inc.Salt Lake City, UT 84116 USA 1-801-595-0700Clinical Information Hotline: 1-800-443-3385Ordering Information: 1-800-545-0890

www.bardaccess.com

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The Power of Purple*

the catheter is being pinched between the clavicle and first rib (the “Pinch-off” sign). Do not continue pulling against resistance as thismay cause catheter breakage and embolism. Free up the resistance (e.g. by repositioning the patient) before proceeding further.

• If the artery is entered, withdraw the needle and apply manual pressure for several minutes. If the pleural space is entered, with-draw the needle and evaluate patient for possible pneumothorax.

• Alcohol should not be used to soak or declot polyurethane catheters because alcohol is known to degrade polyurethane cathetersover time with repeated and prolonged exposure.

• Acetone and polyethylene glycol containing ointments should not be used with polyurethane catheters, as they may damage the device.• Failure to warm contrast media to body temperature 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.• Power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.• Exceeding the maximum flow rate of 5ml/sec, and the maximum pressure of power injectors of 300 psi, may result in catheter fail-

ure and/or catheter tip displacement.• PowerHohn* 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 evaluatingthe health status of a patient as it pertains to a power injection procedure.

• Pinch-off Prevention: Catheters placed percutaneously or through a cut-down, into the subclavian vein, should be inserted at thejunction of the outer and middle thirds of the clavicle, lateral to the thoracic outlet. The catheter should not be inserted into thesubclavian vein medially, because such placement can lead to compression of the catheter between the first rib and the clavicle,which can cause damage and even severance of the catheter. A radiographic confirmation of catheter placement should be madeto ensure that the catheter is not being pinched by the first rib and clavicle. 1,2

Signs of Pinch-offClinical:• Difficulty with blood withdrawal• Resistance to infusion of fluids• Patient position changes required for infusion of fluids or blood withdrawalRadiologic:• Grade 1 or 2 distortion on chest X-ray.

Pinch-off should be evaluated for degree of severity prior to explantation.Patients indicating any degree of catheter distortion at the clavicle/first ribarea should be followed diligently. There are grades of Pinch-off that shouldbe recognized with appropriate chest x-ray as follows: 3,4

Precaut ions:• Carefully read and follow all instructions prior to use.• Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.• Only qualified healthcare practitioners should insert, manipulate and remove this catheter.• When inserting the catheter via a subclavian approach, maintain a horizontal trajectory when introducing the needle beneath

the clavicle. Vertical needle passage may increase the risk of pneumothorax.• If an artery is entered, withdraw the needle and apply manual pressure for several minutes. If the pleural space is entered,

withdraw needle and observe patient for signs of pneumothorax.• If the guidewire must be withdrawn while the needle is inserted, remove both the needle and guidewire as a unit to help pre-

vent the needle from damaging or shearing the guidewire.• Do not attempt to slide the catheter over the wire separately into the vein. This may cause the catheter to bunch up on the wire

making advancement of the catheter into the vessel more difficult.• Contrast media should be warmed before power injection. • Do not grasp the catheter with any instrument that might sever or damage the catheter. • Do not cut the catheter before removal from vein to avoid catheter embolism.• The catheter must be secured in place to minimize the risk of catheter breakage and embolization.• 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.• Follow Universal Precautions when inserting and maintaining the catheter.

Grade

Grade 0

Grade 1

Grade 2

Grade 3

Severity

No distortion

Distortion presentwithout luminalnarrowing

Distortion presentwith luminal nar-rowing

Catheter transec-tion or fracture

Recommended Action

No action.

Chest x-ray should be taken every oneto three months to monitor progressionof pinch off to grade 2 distortion.Shoulder positioning during chest x-rays should be noted as it can contributeto changes in distortion grades.

Removal of the catheter should beconsidered.

Prompt removal of the catheter.

Indications For Use:PowerHohn* catheters are indicated for short or long term access to the central venous system. They are designed for adminis-tering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection ofcontrast media. The maximum recommended infusion rate is 5ml/sec. The maximum pressure of power injectors used with thePowerHohn* catheter may not exceed 300psi.

VitaCuff* Antimicrobial CuffDescription

The VitaCuff* device is designed to help provide protection against infections related tovascular access catheters. The outer, tissue-interfacing surface of the VitaCuff* device mayhelp reduce the incidence of infection by incorporating an antimicrobial agent into theporous collagen matrix.

The VitaCuff* device is comprised of two concentric layers of material. The internal layer is constructed of specially formulatedand processed medical grade silicone. The external, tissue-interfacing layer is VitaGuard* antimicrobial collagen matrix. Theantimicrobial activity of the VitaGuard* material is attributable to the silver ions bound to the collagen matrix. The activity lastsuntil the VitaGuard* matrix is completely absorbed by the tissue in four to six weeks. (Refer to figure 1)The VitaGuard* collagen sponge is initially in a compressed state for ease of insertion. After placement, the matrix absorbsphysiological fluids, quickly expands to approximately twice its original size, and helps provide an antimicrobial barrier and aphysical barrier at the exit site. Tissue ingrowth into the VitaGuard* collagen matrix occurs in a few days, further securing thecatheter in place, and reducing catheter movement.

Proper VitaCuff* Positioning

Caution: The antimicrobial cuff is not intended to be used as a treatment for catheter related infections. The antimicrobial cuffdoes not provide protection against “blood seeding” infection or infusate-related infection. It is not intended to provide protectionfrom bacteria for longer than one month. The antimicrobial cuff should not be used on patients with known sensitivities to silverions or collagen.

Contraindications:The device is contraindicated whenever:• The presence of device related infection, bacteremia, or septicemia is known or suspected.• The patient’s body size is insufficient to accommodate the size of the implanted device.• The patient is known or is suspected to be allergic to materials contained in the device.• Severe chronic obstructive lung disease exists (percutaneous subclavian placement only).• There has been past irradiation of prospective insertion site.• There have been previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.• There are local tissue factors which prevent proper device stabilization and/or access.• Do not use the antimicrobial cuff in patients with known sensitivities to silver ions or collagen.

Warnings:• 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 should notbe reused or resterilized.

• After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice andapplicable local, state and federal laws and regulations.

• This is not a right atrium catheter. Avoid positioning the catheter tip in the right atrium. Placement or migration of the catheter tipinto the right atrium may cause cardiac arrhythmia, myocardial erosion or cardiac tamponade.

• 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 thepatient’s heart before removing the injection cap.

• Place a finger over the needle to minimize blood loss and risk of air aspiration. The risk of air aspiration is reduced by performingthis part of the procedure with the patient holding their breath until the guidewire is inserted into the needle.

• When using alcohol or alcohol containing antiseptics with polyurethane catheters, care should be taken to avoid prolonged orexcessive contact. Solutions should be allowed to completely dry before applying an occlusive dressing. Chlorhexidine glu-conate and/or povidone iodine are the suggested antiseptics to use.

• You should not feel any resistance when withdrawing the catheter from the vein. If you do encounter resistance, this may indicate that

VitaCuff*AntimicrobialCuff

Exit Site

New Important Information:• 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 incatheter failure.

• Vigorously flush the PowerHohn* catheter using a 10ml or larger syringe and sterile normal saline priorto and immediately following the completion of power injection studies. This will ensure the patency ofthe PowerHohn* catheter and prevent damage to the catheter. Resistance to flushing may indicatepartial or complete catheter occlusion. Do not proceed with power injection study until occlusion hasbeen cleared. Warning: Failure to ensure patency of the catheter prior to power injection studies may result incatheter failure.

• Do not exceed the maximum flow rate of 5ml/sec. Warning: Power injector machine pressure limiting feature may not prevent over pressurization of anoccluded catheter. Warning: Exceeding the maximum flow rate of 5ml/sec may result in catheter failure and/or cathetertip displacement.

• Warning: PowerHohn* catheter indication for power injection of contrast media implies the catheter’sability to withstand the procedure, but does not imply appropriateness of the procedure for a particularpatient. A suitably trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure.

Power Injection Procedure1. Remove the end cap(s) from the PowerHohn* catheter.2. Attach a 10ml or larger syringe filled with sterile normal saline.3. Aspirate for adequate blood return and vigorously flush the catheter with the full 10ml 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 PowerHohn* catheter per manufacturer’s recommendations.6. Complete power injection study taking care not to exceed the flow rate limits.

Warning: Exceeding the maximum flow rate of 5ml/sec may result in catheter failure and/or catheter tip displacement.7. Disconnect the power injection device.8. Flush the PowerHohn* catheter with 10ml of sterile normal saline, using a 10ml or larger syringe.9. Replace the end cap(s) on the PowerHohn* catheter.

DescriptionPowerHohn* Central Venous Catheters are constructed of specially formulated and processed polyurethane and are designed forover-the-wire insertion into the central venous system. PowerHohn* catheters have a kink-resistant, reverse-tapered design. Thecatheters are radiopaque with female luer locking adapters and StatLock* device compatible suture wings for fixation. Eachcatheter is provided in a sterile package. Catheters are available with or without VitaCuff* antimicrobial cuff.

PlacementThe catheter is placed into one of the central veins so the tip lies in the superior vena cava above the right atrium.

Schematics:

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:New Important Information:

• Follow all contraindications, warnings, cautions, precautions and instructions for all infusates, including contrast media, asspecified by its manufacturer.

• Use aseptic techniques whenever the catheter lumen is opened or connected to other devices. Povidone-iodine or chlorhexa-dine gluconate are the suggested antiseptics to use with this device and components. Acetone and tincture of iodine shouldnot be used because they could adversely affect the performance of the catheter and connectors. 10% acetone/70% isopropylalcohol swabsticks used for dressing changes should not adversely affect the catheter.

• Patients with thick muscular chest walls or extensive scar tissue may require the use of a percutaneous introducer for catheterinsertion.

• Catheters can be cut to length if a different length is desired due to patient size and desired point of insertion according to hos-pital protocol. Catheter depth markings are in centimeters. Use caution when using scissors or any sharp-edged instruments asthey could damage the catheter.

• Examine package carefully before opening to confirm its integrity and that the expiration date has not passed. The catheter issupplied in a double sterile package and is non-pyrogenic. Do not use if package is damaged, opened or the expiration datehas passed. Sterilized by ethylene oxide. Do not resterilize.

• Inspect kit for inclusion of all components. • When device includes an antimicrobial cuff, do not expose the cuff to fluids prior to insertion. Handle carefully to avoid cuff damage. • Fill (prime) the device with sterile heparinized saline or normal saline solution to help avoid air embolism. • When using an introducer kit, verify that the catheter fits easily through the introducer sheath.

• Avoid accidental device contact with sharp instruments and mechanical damage to the catheter material. Use only smooth-edged atraumatic clamps or forceps.

• Avoid perforating, tearing or fracturing the catheter when using a guidewire. • Do not use the catheter if there is any evidence of mechanical damage or leaking.• Avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen(s).• Sutures should not be tied around the catheter itself. The suture wings will secure the catheter without compromising catheter

patency. • When using percutaneous introducers:

- Carefully insert the introducer and catheter to avoid inadvertent penetration to vital structures in the thorax.- To avoid blood vessel damage, do not allow the percutaneous introducer sheath to remain indwelling in the blood vessel

without the internal support of a catheter or dilator. - Simultaneously advance the dilator with rotational motion to help prevent damage.

• During insertion of catheter with antimicrobial cuff:- Minimize the exposure of the cuff to pooled blood by sponging the intended cuff placement site. - The entire collagen (tan) portion of the cuff must be in the subcutaneous tissue at the catheter exit site.

• Do not use the catheter if there is any evidence of mechanical damage or leaking. Damage to the catheter may lead to rup-ture, fragmentation and possible embolism and surgical removal.

• Accessories and components used in conjunction with this device should incorporate luer lock connections.• If signs of extravasation exist, discontinue injections. Begin appropriate medical intervention immediately.• Prolonged infusion pressure greater than 25 psi (172 kPa) may damage blood vessels and viscus and is not recommended.

Do not use a syringe smaller than 10 ml!

Possible ComplicationsThe potential exists for serious complications including the following.

• Air Embolism• Allergic Reaction to Silver or Collagen

(Catheters with VitaCuff* AntimicrobialCuff Only)

• Bleeding• Brachial Plexus Injury• Cardiac Arrhythmia• Cardiac Tamponade• Catheter or Cuff Erosion Through

the Skin• Catheter Embolism• Catheter Occlusion• Catheter Occlusion, Damage or

Breakage due to Compression betweenthe Clavicle and First Rib (Pinch-off)

• Catheter-related Sepsis• Endocarditis• Exit Site Infection• Exit Site Necrosis• Extravasation• Fibrin Sheath Formation• Hematoma• Hemothroax• Hydrothorax• Intolerance Reaction to Implanted

Device• Laceration of Vessels or Viscus• Myocardial Erosion • Perforation of Vessels or Viscus• Phlebitis

• Pneumothorax• Spontaneous Catheter Tip Malposition

or Retraction• Thromboembolism• Thoracic Duct Injury• Venous Thrombosis• Ventricular Thrombosis• Vessel Erosion• Risks Normally Associated with Local

or General Anesthesia, Surgery, andPost-Operative Recovery

III. After placement:

II. During placement:

I. Prior to placement:

Hubs Thumb Clamps

ID Tags

Molded Junction Reverse Taper TubingVitaCuff * Antimicrobial Cuff

1

First RibSubclavian Vein

Clavicle

Vertebra

Internal Jugular Vein

Superior Vena Cava

SternumPinch-off Area

Infraclavicular Fossa

Axillary Vein

Grade

Grade 0

Grade 1

Grade 2

Grade 3

Severity

No distortion

Recommended Action

No action.

Exit Site

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New Important Information:• Follow all contraindications, warnings, cautions, precautions and instructions for all infusates, including contrast media, as

specified by its manufacturer. • Use aseptic techniques whenever the catheter lumen is opened or connected to other devices. Povidone-iodine or chlorhexa-

dine gluconate are the suggested antiseptics to use with this device and components. Acetone and tincture of iodine shouldnot be used because they could adversely affect the performance of the catheter and connectors. 10% acetone/70% isopropylalcohol swabsticks used for dressing changes should not adversely affect the catheter.