English • If the prospective insertion site has been previously irradiated. • If the prospective placement site has ­­­­previously suffered episodes of venous thrombo- sis or vascular surgical procedures. * • If local tissue factors may prevent proper device stabilization and/or access. ChloraPrep* Solution One-Step Applicator SHORT-TERM DIALYSIS Contraindications • Do not use in children less than 2 months of age because of the poten- tial for excessive skin irritation and increased drug absorption. Short-Term Dialysis Catheter • Do not use on patients with known allergies to chlorhexidine gluconate Instructions For Use or isopropyl alcohol. USA Only • Do not use for lumbar puncture or allow contact with meninges. * • Do not use on open skin wounds or as a general skin cleanser.

New Important Information: Warnings First Rib Vertebra • Contrast media should be SHORT-TERMwarmed to body DIALYSIS temperature CATHETER (37°C) prior Subclavian • SUBCLAVIAN ONLY. to power injection. Percutaneous insertion of the Internal Jugular Vein Warning: Failure to warm contrast media to body temperature catheter must be made into Clavicle (37°C) prior to power injection may result in catheter failure (e.g. the axillary-subclavian vein at

catheter rupture). the junction of the outer and Axillary Vein Sternum • Vigorously flush the catheter using a 10 mL or larger syringe and mid-third of the clavicle lateral Pinch-off Area sterile normal prior to and immediately following the comple- to the thoracic outlet. The catheter must not be inserted Infraclavicular Fossa tion of power injection studies. This will ensure the patency of into the subclavian vein medi- the catheter and prevent damage to the catheter. Resistance to ally, because such placement can lead to compression of the catheter between the first flushing may indicate partial or complete catheter occlusion. Do rib and clavicle and can lead to damage or fracture and embolization of the catheter. not proceed with power injection study until occlusion has been Fluoroscopic or radiographic confirmation of catheter tip placement can be helpful in cleared. demonstrating that the catheter is not being pinched by the first rib and clavicle. 1 Warning: Failure to ensure patency of the catheter prior to power Signs of Pinch-off injection studies may result in catheter failure. • Use only the lumen marked “Power Injectable” for power injection Clinical: • Difficulty with withdrawal. of contrast media. • Resistance to infusion of fluids. Warning: Do not use lumens not marked “Power Injectable” for • Patient position changes required for infusion of fluids or blood withdrawal. power injection of contrast media. • Do not exceed the maximum flow rate of 5 mL/sec. Radiologic: (see table) Warning: Power injector machine pressure limiting feature may • Grade 1 or 2 distortion on chest X-ray. not prevent over-pressurization of an occluded catheter, which may lead to catheter failure. Radiologic Signs of Pinch-Off Warning: Exceeding the maximum flow rate of 5 mL/sec or the Grade 0 No distortion No action. maximum pressure of power injectors of 300 psi may result in cath- eter failure and/or catheter tip displacement. Distortion present Chest x-ray should be taken to monitor • Warning: Catheter indication for power injection of contrast without luminal progression of pinch-off to grade 2 narrowing distortion. Shoulder positioning during media implies the catheter’s ability to withstand the procedure, but Grade 1 it does not imply appropriateness of the procedure for a particular chest x-rays should be noted as it can contribute to changes in distortion patient. A suitably trained clinician is responsible for evaluating the grades. health status of a patient as it pertains to a power injection proce- dure. Distortion present Removal of the catheter should be • Warning: Do not power inject through a catheter that exhibits Grade 2 with luminal considered. signs of clavicle-first rib compression or pinch-off, as it may result in narrowing catheter failure. Catheter transection Prompt removal of the catheter. • Warning: If local pain, swelling, or signs of extravasation are Grade 3 or fracture noted, the injection should be stopped immediately.

Power Injection Procedure Pinch-off should be evaluated for degree of severity prior to explantation. Patients indi- 1. Remove the end cap from the catheter. cating any degree of catheter distortion at the clavicle/first rib area should be followed 2. Attach a 10 mL or larger syringe filled with sterile normal saline. diligently. There are grades of Pinch-off that should be recognized with appropriate 2,3 3. Aspirate for adequate blood return and vigorously flush the catheter with the full chest x-ray as follows: 10 mL of sterile normal saline. • The catheter must not be left in the femoral vein longer than three days. It is recom- Warning: Failure to ensure patency of the catheter prior to power injection stud- mended that jugular and subclavian be replaced after four weeks. ies may result in catheter failure. • Alcohol or alcohol-containing antiseptics (such as chlorhexidine gluconate) may be 4. Detach syringe. used to clean the catheter/skin site; however, care should be taken to avoid prolonged 5. Attach the power injection device to the catheter per manufacturer’s recommen- or excessive contact of the catheter with the solution(s). Solutions should be allowed to dations. completely dry before applying an occlusive dressing. 6. Contrast media should be warmed to body temperature (37°) prior to power injec- • Acetone and Polyethylene Glycol (PEG)-containing ointments can cause failure of this tion. device and should not be used with polyurethane catheters. Chlorhexidine patches or Warning: Failure to warm contrast media to body temperature (37°) prior to bacitracin zinc ointments are the preferred alternative. power injection may result in catheter failure. • Do not resterilize the catheter or components by any method. The manufacturer will 7. Use only the lumen marked “Power Injectable” for power injection of contrast not be liable for any damages caused by re-use of the catheter or accessories. ­­ media. • Intended for Single Use. DO NOT REUSE. Reuse and/or repackaging may create a risk of Warning: Use of lumens not marked “Power Injectable” for power injection patient or user infection, compromise the structural integrity and/or essential material of contrast media may cause failure of the catheter. and design characteristics of the device, which may lead to device failure, and/or lead 8. Complete power injection study taking care not to exceed the flow rate limits. to injury, illness or death of the patient. Warning: Exceeding the maximum flow rate of 5 mL/sec or the maximum pres- • Place all clamps near the center of the polyurethane extension pieces. Polyurethane sure of power injectors of 300 psi may result in catheter failure and/or catheter tip may develop cuts or tears if subjected to excessive pulling or contact with rough edges. displacement. Repeated clamping near or on the Luer-lock connectors may cause tubing fatigue and Warning: Power injector machine pressure limiting feature may not prevent possible disconnection. over-pressurization of an occluded catheter, which may lead to catheter failure. • Repeated over-tightening of bloodlines, syringes and caps will reduce connector life 9. Disconnect the power injection device. and may lead to connector failure. 10. Flush the catheter with 10 mL of sterile normal saline, using a 10 mL or larger • Enzymes in blood and heparin may cause temporary sticking of the extensions when syringe. In addition, lock the lumen marked “Power Injectable” per institution pro- clamped for extended periods of time. To release, open clamp and slide away, gently tocol for central lines. Usually one mL is adequate. rotating the tube between finger and thumb until the tubing separates. 11. Close clamp and replace the end cap on the catheter. • 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 Description syringes generate more pressure than larger syringes. Power-Trialysis* Short-Term Dialysis catheters are made of thermosensitive polyure- NOTE: A three pound (13.3 Newton) force on the plunger of a 3 mL syringe generates thane, which softens when exposed to body temperature. The catheter is divided into pressure in excess of 30 psi (206 kPa) whereas the same three pound (13.3 Newton) three separate lumens permitting continuous blood flow. Both the venous (blue) and the force on the plunger of a 10 mL syringe generates less than 15 psi (103 kPa) of pressure. arterial (red) lumens may be used for , hemoperfusion, and apheresis treat- • Accessories and components used in conjunction with this catheter must incorporate ments. The distal (purple) lumen is completely independent from the two dialysis lumens Luer-lock adapters in order to avoid inadvertent disconnection. and may be used for , power injection of contrast media, and central • Catheters should be implanted carefully to avoid any sharp or acute angles which could venous pressure monitoring.­­­ The distal lumen can also be accessed for blood draws and compromise the opening of the catheter lumens. infusion of medications. • 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. Indications For Use • In the rare event of a leak, the catheter must be clamped immediately. Necessary reme- dial action must be taken prior to resuming dialysis procedure. The Power-Trialysis* Short-Term Dialysis Catheter, with a third internal lumen for • If the catheter is not used immediately for treatment, follow the suggested Catheter intravenous therapy, power injection of contrast media, and central venous pressure Patency Guidelines. monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access • Failure to clamp extensions when not in use may lead to . for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to • Verification of the catheter tip location must be confirmed by x-ray to ensure proper be inserted in the jugular, femoral, or subclavian vein as required. The maximum recom- placement. mended infusion rate is 5 mL/sec for power injection of contrast media. • To prevent systemic heparinization of the patient, the heparin solution must be aspi- rated out of the lumens immediately prior to using the catheter. Contraindications • For jugular and subclavian insertion, the patient must be placed on a cardiac monitor The catheter is intended for short-term vascular access only and is not to be used for any during this procedure. Cardiac arrhythmia may result if the guidewire is allowed to pass purpose other than indicated in these instructions. into the right atrium. The guidewire must be held securely during the procedure. • The risk of infection is increased with femoral vein insertion. The device is also contraindicated : • Recirculation in femoral catheters was reportedly significantly greater than in internal • When the presence of device related infection, bacteremia, or septicemia is known or jugular catheters. 7 suspected. • Before attempting the insertion of the catheter, ensure that you are familiar with the • When the patient’s body size is insufficient to accommodate the size of the implanted possible complications listed below and their emergency treatment should they occur. device. • Cannulation of the left internal jugular vein was reportedly associated with a higher • When the patient is known or is suspected to be allergic to materials contained in the incidence of complications compared to catheter placement in the right internal jugular device. vein. 4 1 • Failure to warm contrast media to body temperature (37°C) prior to power injection Completely wet the treatment area with antiseptic. Allow the area to dry for approxi- may result in catheter failure. mately 30 seconds. Do not blot or wipe away. • Failure to ensure patency of the catheter prior to power injection studies may result in • Maximum treatment area for one applicator is approximately 130 cm2 catheter failure. (approximately 4 x 5 in.). Discard the applicator after a single use. • Do not use lumens not marked “Power Injectable” for power injection of contrast • Remove and discard gloves. media. 3. Prepare a sterile field. • Power injection machine pressure limiting feature may not prevent over-pressurization 4. The insertion site is identified. A local anesthetic is injected over the site. of an occluded catheter, which may lead to catheter failure. 5. A syringe is attached to an introducer needle that will permit passage of the guide- • Exceeding the maximum flow rate of 5 mL/sec or the maximum pressure of power wire. The maximum guidewire that may be used is 0.035 in. (0.89 mm) injectors of 300 psi may result in catheter failure and/or catheter tip displacement. 6. The introducer needle is inserted into the identified vein. • Catheter indication for power injection of contrast media implies the catheter’s ability 7. The syringe is removed leaving the introducer needle in place. to withstand the procedure, but does not imply appropriateness of the procedure for WARNING: For jugular and subclavian insertion, the patient must be placed on a cardiac a particular patient. A suitably trained clinician is responsible for evaluating the health monitor during this procedure. Cardiac arrhythmia may result if the guidewire is allowed status of a patient as it pertains to a power injection procedure. to pass into the right atrium. The guidewire must be held securely during the procedure. • Do not power inject through a catheter that exhibits signs of clavicle-first rib compres- 8. The guidewire can be inserted into the needle hub and passed through the needle. sion or pinch-off, as it may result in catheter failure. Advance the guidewire to the desired location in the vessel. • If local pain, swelling, or signs of extravasation are noted, the injection should be CAUTION: Do not pull back guidewire over needle bevel as this may sever the end of stopped immediately. the guidewire. The introducer needle must be removed first. Also, if unusual resistance • After use, this product may be a potential biohazard. Handle and discard in accordance is met during manipulation of the guidewire, discontinue the procedure and deter- with accepted medical practice and applicable local, state and federal laws and regula- mine the cause of resistance before proceeding. Withdraw needle and guidewire if tions. cause of resistance cannot be determined. • CVP Monitoring should always be used in conjunction with other patient assessment 9. Holding the guidewire securely in place, remove the introducer needle. metrics when evaluating cardiac function. CAUTION: Do not allow the guidewire to inadvertently advance totally into the vessel. • CVP Monitoring should not be performed during hemodialysis, hemoperfusion or 10. The introducer needle tract is widened by creating a small surgical incision at the skin apheresis. exit site. The incision should be slightly larger than the wide/flat side of the catheter. • For optimal product performance and to avoid complications, do not insert any portion 11. Use the Dualator* vessel dilator(s) to dilate the subcutaneous tissues. Dilate 2-3 times of the curve into the vein. with slow gradual movements. The larger portion of the Dualator* dilator device must enter the vein prior to catheter insertion. ChloraPrep* Solution One-Step Applicator Warnings 12. Flush each lumen of the catheter with saline or heparinized saline filled syringes and • Flammable, keep away from fire or flames. clamp the venous (blue) and arterial (red) lumens. • Do not use with electrocautery procedures. 13. The catheter is passed over the proximal end of the guidewire by inserting the guide- • For external use only. wire tip into the tapered end of the catheter. The distal (purple) lumen clamp must • When using this product keep out of eyes, ears, and mouth. May cause serious or per- be in the open position to allow the catheter to pass completely over the guidewire manent injury if permitted to enter and remain. If contact occurs, rinse with cold water and into the vein. Insert the catheter flat side to the skin. right away and contact a physician. 14. Pinch guidewire and catheter together, advance together in 5 to 10 cm increments • Stop use and ask doctor if irritation, sensitization, or allergic reaction occurs. These may (retract wire as needed). Do not twist the catheter during over-the-guidewire insertion. be signs of a serious condition. 15. The depth markings in one cm increments may be used to determine insertion depth. • Keep out of reach of children. If swallowed, get medical help or contact a poison con- 16. The catheter tip must be in the lower superior vena cava for optimal performance. If trol center right away. placed femorally, the catheter tip should be placed in the inferior vena cava to mini- mize recirculation.7 CAUTION: For jugular and subclavian insertion, the catheter tip Cautions should not be located in the right atrium. WARNING: Verification of the catheter tip • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. location must be confirmed by x-ray. • Carefully read and follow all instructions prior to use. 17. The guidewire is removed, and the distal (purple) lumen clamp is closed. Flush the • Only qualified health care practitioners should insert, manipulate, and remove these lumens again with saline or heparinized saline filled syringes. It is necessary to open devices. the extension clamps during the flush procedure. Close clamps on all lumens and • Strict aseptic technique must be used during the insertion, maintenance, and catheter place end caps over the ends of each Luer-lock connector. removal procedures. 18. The rotatable, pre-attached suture wing is oriented to the skin surface and the cath- • Do not pull back guidewire over needle bevel as this may sever the end of the guide- eter is attached using a suture. wire. The introducer needle must be removed first. Also, if unusual resistance is met 19. When placing the catheter, use the removable suture wing to minimize movement during manipulation of the guidewire, discontinue the procedure and determine the at the exit site. 1. Using your fingers, squeeze the suture wing together so that it cause of resistance before proceeding. Withdraw needle and guidewire if cause of splits open and place the wing around the catheter near the venipuncture site. 2. resistance cannot be determined. Secure the wing onto the catheter by tying sutures around the wing using the suture • Do not allow the guidewire to inadvertently advance totally into the vessel. grooves. 3. Secure the removable wing in place by suturing through the holes or by • For jugular and subclavian insertion, the catheter tip should not be located in the using adhesive wound closures. right atrium. WARNING: For optimal product performance and to avoid complications, do not • Sterile, non-pyrogenic unless package is damaged or opened. insert any portion of the curve into the vein. • Left sided placement in particular, may provide unique challenges due to the right 20. A sterile, transparent, semi-permeable, dressing is used to cover the skin exit site. angles formed by the innominate vein and at the left brachiocephalic junction with WARNING: Verification of the catheter tip location must be confirmed by x-ray to the left SVC.5, 6 ensure proper placement. • Follow all contraindications, warnings, precautions, and instructions for all infusates, 21. The catheter is now ready for use. For hemodialysis, hemoperfusion, or apheresis the including contrast media, as specified by their manufacturer. arterial (red) lumen of the catheter is connected to the arterial side of the extracorpo- Possible Complications real circuit. The venous (blue) lumen of the catheter is connected to the venous side of the extracorporeal circuit. The use of an indwelling provides an important means of venous access for critically ill patients; however, the potential exists for serious complications PERFORMANCE GUIDELINES: (As suggested by In Vitro data) including the following: Flow Rate vs Lumen Pressure (400mL/min Flow Rate) • Air Embolism • Hemomediastinum 30 cm Straight 24 cm Curved Extension • Arterial Puncture • Hemothorax • Bleeding • Hydrothorax Venous (mmHg) 226 193 • Brachial Plexus Injury • Inflammation, Necrosis or Scarring of Skin Arterial (mmHg) -231 -195 • Cardiac Arrhythmia Over Implant Area • Cardiac Tamponade • Intolerance Reaction to Implanted Device • Catheter Erosion Through • Laceration of Vessels or Viscus Third Lumen Gravity Flow Rate (1 Meter of Water Infusion Pressure) the Skin • Perforation of Vessels or Viscus Insertion Length (cm) Gravity Flow Rate - (mL/hr) • Catheter Embolism • Pneumothorax 30 cm 2258 • Catheter Occlusion • Spontaneous Catheter Tip Malposition or • Catheter Occlusion, Damage or Breakage Retraction 24 cm 2634 due to Compression between the Clavicle • Thoracic Duct Injury 20 cm 2830 and First Rib 1 • Thromboembolism 15 cm 3333 • Catheter-Related Sepsis • Venous Stenosis • Endocarditis • Venous Thrombosis 12.5 cm 3721 • Exit Site Infection • Ventricular Thrombosis • Exit Site Necrosis • Vessel Erosion Central Venous pressure Monitoring (CVP) • Extravasation • Risks Normally Associated with Local and • Prior to conducting central venous pressure monitoring. • Fibrin Sheath Formation General Anesthesia, Surgery, and Post- • Ensure proper positioning of the catheter tip. • Hematoma Operative Recovery • Flush catheter vigorously with sterile normal saline. These and other complications are well documented in medical literature and must be • Ensure the pressure transducer is at the level of the right atrium. carefully considered before placing the catheter. Placement and care of the catheter • It is recommended that a continuous infusion of saline (3 mL/hr) is maintained must be performed only by persons knowledgeable of the risks involved and qualified in through the catheter while measuring CVP to improve accuracy of CVP results. the procedures. • CVP Monitoring is intended to be performed through the distal (purple) lumen. • Use your institution’s protocols for central venous pressure monitoring procedures. Instructions for Catheter Insertion WARNING: CVP Monitoring should always be used in conjunction with other patient CATHETERS MUST BE INSERTED UNDER STRICT ASEPTIC CONDITIONS. assessment metrics when evaluating cardiac function. WARNING: Cannulation of the left internal jugular vein was reportedly associated WARNING: CVP Monitoring should not be performed during hemodialysis, hemoper- with a higher incidence of complications compared to catheter placement in the right fusion, or apheresis. internal jugular vein. 4 CAUTION: As reported in literature, left sided catheter placement may provide unique CARE AND MAINTENANCE challenges due to the right angles formed by the innominate vein and at the left bra- The care and and maintenance of the catheter requires well-trained, skilled personnel chiocephalic junction with the SVC. 5,6 following a detailed protocol. The protocol should include a directive that the catheter is 1. The catheter must be inserted only under strict aseptic conditions in which the opera- not to be used for any purpose other than the prescribed therapy. tor must wear a cap, mask, sterile gown, sterile gloves, and use a large sterile drape to Accessing Catheter, Cap Changes, Dressing Changes10 cover the patient. For jugular or subclavian insertion, the patient must be in a modi- • Experienced personnel fied Trendelenburg position, with the head turned to the side opposite that of the • Use aseptic technique insertion site. A small rolled towel may be inserted between the shoulder blades. For • Proper hand hygiene femoral insertion, place patient in supine position to expose the side of the groin to • Clean gloves to access catheter and remove dressing and sterile gloves for be accessed. dressing changes 2. Prepare the access site using standard surgical technique and drape the prepped • Surgical mask (1 for the patient and 1 for the healthcare professional) area with sterile towels. If hair removal is necessary, use clippers or depilatories. Next, • Catheter exit site should be examined for signs of infection and dressings should scrub the entire area preferably with chlorhexidine gluconate unless contraindicated, be changed at each dialysis treatment. in which case, povidone-iodine may be used. Use a back-and-forth friction scrub for • Catheter Luer-lock connectors with end caps attached should be soaked for 3 to 5 minutes in povidone iodine and then allowed to dry before separation. at least 30 seconds9. Do not wipe or blot. Allow antiseptic to air dry completely before • Carefully remove the dressing and inspect the exit site for inflammation, swelling puncturing the site. Remove and discard gloves. If using the ChloraPrep* Solution and tenderness. Notify physician immediately if signs of infection are present. One-Step Applicator perform skin preparation using the following steps: • Prepare the site with the ChloraPrep* Solution One-Step Applicator or according Exit Site Cleaning12 to institution protocol using sterile technique. • Use aseptic technique (as outlined above). • Pinch the wings of the ChloraPrep* Solution One-Step Applicator to break the • Clean the exit site at each dialysis treatment with chlorhexidine gluconate unless ampule and release the antiseptic. Do not touch the sponge. contraindicated. Apply antiseptic per manufacturer’s recommendations. Allow to air • Wet the sponge by repeatedly pressing and releasing the sponge against the treat- dry completely. ment area until fluid is visible on the skin. • Cover the exit site with sterile, transparent, semipermeable dressing or per hospital • Use repeated back-and-forth strokes of the sponge for at least 30 seconds. protocol. 2 Recommended Cleaning Solutions THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED (INCLUDING, WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY Catheter Luer-lock Exit Site: OR FITNESS FOR A PARTICULAR PURPOSE). THE LIABILITY AND REMEDY STATED IN Connectors/End Caps: • Chlorhexidine gluconate 2% solution THIS LIMITED PRODUCT WARRANTY WILL BE THE SOLE LIABILITY OF BARD ACCESS 10, 11, 12, 13, 14 • Povidone iodine (preferred) SYSTEMS, INC. AND REMEDY AVAILABLE TO PURCHASER FOR THIS PRODUCT, WHETHER IN (allow connectors/end caps to • Chlorhexidine gluconate 4% solution CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, AND BARD ACCESS SYSTEMS, 6 soak for 3 to 5 minutes) • Dilute aqueous sodium hypochlorite INC. WILL NOT BE LIABLE TO PURCHASERS FOR ANY INDIRECT, SPECIAL, INCIDENTAL OR • 0.55% sodium hypochlorite solution CONSEQUENTIAL DAMAGES ARISING OUT OF ITS HANDLING OR USE. WARNING: Alcohol should not be used to • Povidone iodine lock, soak or declot polyurethane Dialysis • Hydrogen peroxide Some states/countries do not allow an exclusion of implied warranties, incidental or con- Catheters because alcohol is known to • Chlorhexidine patches sequential damages. You may be entitled to additional remedies under the laws of your degrade polyurethane catheters over time • Bacitracin zinc ointments in state/country. An issued or revision date for these instructions is included for the user’s with repeated and prolonged exposure. petrolatum bases 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 Hand cleaner solutions are not intended WARNING: Acetone and Polyethylene is available. to be used for disinfecting our dialysis Glycol (PEG)-containing ointments can catheter Luer-lock connectors. cause failure of this device and should Revised date: October 2011 not be used with polyurethane catheters. Chlorhexidine patches or bacitracin zinc *Bard, Dualator and Power-Trialysis are trademarks and/or registered trademarks ointments (e.g., Polysporin* ointment) are of C. R. Bard, Inc. All other trademarks are the property of their respective owners. the preferred alternative. © 2011 C. R. Bard, Inc. All rights reserved. POST DIALYSIS Use aseptic technique (as outlined above). 1. Flush arterial and venous lumens with a minimum of 10 mL of sterile saline. WARNING: To avoid damage to vessels and viscus, 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. 2. Inject heparin solution into both the arterial and venous lumens of the catheter. The appropriate heparin solution concentration and flushing frequency should be based EC REP on hospital protocol. Heparin solution of 1,000 to 5,000 units/mL has been found Bard Access Systems, Inc. 605 North 5600 West Bard Limited to be effective for maintaining the patency of hemodialysis and apheresis catheters. Forest House, Brighton Road When injecting heparin solution, inject quickly and clamp extension while under Salt Lake City, UT 84116 USA Crawley, West Sussex positive pressure. Heparin solution volume to lock each lumen must be equal to the 1-801-522-5000 RH11 9BP UK priming volume of each lumen. Priming volumes are marked on each lumen. In most instances, no further heparin solution injection is necessary for 48-72 hours, provided the catheter has not been aspirated or flushed. Clinical Information Hotline: 1-800-443-3385 3. Maintain patency of distal (purple) lumen per institution protocol for central lines. Ordering Information: 1-800-545-0890 4. Clean catheter Luer-lock connectors per hospital protocol. Attach sterile end caps to www.bardaccess.com both the arterial and the venous clamping extension pieces. WARNING: To prevent systemic heparinization of the patient, the heparin solution must be aspirated out of both lumens immediately prior to using the catheter. POWER INJECTIONS Français Catheter testing included 10 power injection cycles. * CATHETER REMOVAL Evaluate the catheter routinely and promptly remove any nonessential catheter12 per physician’s orders. The white retention cuff facilitates tissue in-growth. The catheter must be surgically removed. Free the cuff from the tissue and pull the catheter gently SHORT-TERM DIALYSIS CATHETER and smoothly. After removing the catheter, apply manual pressure to the puncture site for 10-15 minutes until no signs of bleeding are present. Then apply sterile, transparent, semipermeable dressing or dressing per hospital protocol for a minimum of 8 hours. Cathéter de dialyse à court terme Follow hospital protocol regarding bedrest after catheter removal. Mode d’emploi DISPOSAL * After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and all applicable local, state and federal laws and regulations. Nouvelles informations importantes : TROUBLESHOOTING • Le produit de contraste doit SHORT-TERMêtre porté à la DIALYSIS température CATHETER du corps (37 °C) PATIENT WITH FEVER avant l’injection à haute pression. Patient with fever and chills following the procedure may be indicative of catheter-related Avertissement : Le fait de ne pas réchauffer le produit de contraste à bacteremia. If bacteremia is present, removal of the catheter may be indicated. la température corporelle (37 °C) avant l’injection à haute pression peut entraîner un dysfonctionnement du cathéter (par ex. rupture du cathéter). INSUFFICIENT FLOW • Rincer vigoureusement le cathéter à l’aide d’une seringue de10 ml ou plus Excessive force must not be used to flush an obstructed lumen. Insufficient blood flow et de solution saline stérile normale avant et immédiatement après la fin may be caused by an occluded tip resulting from a clot or by contacting the wall of the des injections à haute pression. Ce processus garantira la perméabilité du vein. If manipulation of the catheter or reversing arterial and venous lines does not help, then the physician may attempt to dissolve the clot with a thrombolytic agent (e.g., TPA, cathéter et empêchera l’endommagement du cathéter. La résistance au Cathflo* Activase* thrombolytic). Physician discretion advised. rinçage peut traduire une obstruction partielle ou complète du cathéter. Ne pas continuer l’injection à haute pression avec la suppression de CATHETER EXCHANGE l’obstruction. Do not routinely replace dialysis catheters to prevent catheter-related infections14. It Avertissement : Le fait de ne pas vérifier la perméabilité du cathéter may become necessary to exchange the indwelling catheter due to a persistent rise in avant les études d’injection forcée peut conduire à un dysfonctionnement pressures or decrease of flow rates which cannot be rectified through troubleshooting. du cathéter. Catheter exchanges should be performed under strict aseptic conditions in which the physician should wear a cap, mask, sterile gown, sterile gloves, and use a large sterile • Utiliser uniquement les lumières marquées « Power injectable » (Injectable drape to cover the patient. sous pression) pour l’injection à haute pression de produit de contraste. Avertissement : Ne pas utiliser de lumières non marquées « Power injectable » (Injectable sous pression) pour l’injection à haute pression de REFERENCES produit de contraste. • Ne pas dépasser le débit maximum de 5 ml/sec. 1 Aitken, D.R. and Minton, J.P.; “The Pinch-Off Sign: A Warning of Impending Problems Avertissement : La fonctionnalité de limitation de pression de with Permanent Subclavian Catheters,” American Journal of Surgery, 1984 Nov; 148: l’injecteur sous pression peut ne pas empêcher la surpression d’un cathé- 633-38. ter obstrué, ce qui peut entraîner un dysfonctionnement du cathéter. 2 Hinke, D.H.; Zandt-Stastny, D.A.; Goodman, L.R.; et al. “Pinch-off Syndrome: A Avertissement : Le dépassement du débit maximal de 5 ml/sec. ou de Complication of Implantable Subclavian Venous Access Devices,” Radiology, 1990, 177: la pression maximale de 300 psi des injecteurs sous pression peut entraîner 353-356. un dysfonctionnement du cathéter et/ou le déplacement de son embout. 3 Ingle, R., Nace, C., “Venous Access Devices: Catheter Pinch-off and Fracture,” 1993, Bard Access Systems. • Avertissement : L’indication du cathéter pour l’injection forcée de 4 Sulek, C.A., Blas, M.L., Lobato, E.B., “A Randomized Study of Left Versus Right Internal produit de contraste implique la capacité du cathéter à résister à la Jugular Vein Cannulation in Adults,” procédure, mais ne garantit pas la pertinence de la procédure pour un J Clin Anesth, 2000 Mar; 12(2): 142-5. patient donné. Un clinicien formé de façon adéquate est responsable de 5 Mickely, V., “Central venous catheters: Many questions: Few answers,” Nephrol Dial l’évaluation de l’état de santé d’un patient en ce qui concerne la procédure Transplant, 2002, 17: 1368-73. d’injection forcée. 6 Tan, P.L., Gibson, M., “Central Venous Catheters : The Role of Radiology,” Clin Rad, 2006 ; • Avertissement : Ne pas faire d’injection via un cathéter démontrant des 61: 13-22. signes de compression ou de pincement entre la clavicule et la première 7 National Kidney Foundation K/DOQI GUIDELINES 2000, 2006. côte puisque cela pourrait conduire à un dysfonctionnement du cathéter. 8 Octavio, Bella, Colemenares, Garcia, and Flores; “Right Verses Left Internal Vein • Avertissement : En cas de douleur locale, de gonflement ou de signes Catheterization for Hemodialysis: Complications and Impact on Ipsilateral Access d’extravasation, l’injection doit être immédiatement interrompue. Creation,” Artifical Organs; 2004, 28(8):728-733. 9 The Institute for Healthcare Improvement, “How-to-Guide: Prevent Central Line Procédure d’injection à haute pression Infections,” 2006. 10 National Kidney Foundation K/DOQI Guidelines, 2006. 1. Retirer le bouchon du cathéter. 2. Fixer une seringue de 10 ml ou plus remplie de solution saline stérile. 11 The Institute for Healthcare Improvement, “How-to-Guide: Prevent Central Line 3. Aspirer pour obtenir un retour sanguin adéquat et rincer vigoureusement le cathéter avec Infections,” 2006. 10 ml de solution saline. 12 The Joint Commission Hospital Accreditation Organization, National Patient Safety Avertissement : Le fait de ne pas vérifierla perméabilité du cathéter avant injection à Goals, 2009. haute pression peut conduire à un dysfonctionnement du cathéter.

13 Center for Disease Control and Prevention, “Guidelines for the Prevention of 4. Détacher la seringue. Intravascular Catheter-Related Infections,” Morbidity and Mortality Weekly Report, Aug. 5. Fixer le dispositif d’injection à haute pression sur le cathéter suivant les recommandations 9, 2002, 51(RR-10), 1-32. du fabricant. 14 The Society for Healthcare Epidemiology of America, “Strategies to Prevent Central 6. Le produit de contraste doit être porté à la température du corps (37°) avant l’injection à Line-Associated in Acute Care Hospitals,” Infection Control and haute pression. Hospital Epidemiology, Oct. 2008, 29(S1): S22-S30. aVErtissement : Le fait de ne pas réchauffer le produit de contraste à la température corporelle (37 °C) avant une injection à haute pression peut conduire à un dysfonc- Other references available upon request. tionnement du cathéter. 7. Utiliser uniquement les lumières marquées « Power injectable » (Injectable sous pression) Bard Access Systems, Inc. warrants to the original purchaser that this product will be free pour l’injection à haute pression de produit de contraste. from defects in material and workmanship for a period of one (1) year from the date of pur- Avertissement : L’utilisation de lumières non marquées « Power injectable » chase. If this product proves to be so defective, purchaser may return same to Bard Access (Injectable sous pression) pour l’injection à haute pression de produit de contraste Systems, Inc. for repair or replacement, at Bard Access Systems, Inc.’s option. All returns peut entraîner un dysfonctionnement du cathéter. must be authorized in advance in accordance with Bard Access Systems, Inc.’s Returned 8. Injecter la totalité du produit de contraste en prenant soin de ne pas dépasser les limites de débit. Goods Policy found in its then current Price List. The liability of Bard Access Systems, Inc. Avertissement : Le dépassement du débit maximal de 5 ml/sec ou de la pression under this limited product warranty does not extend to any abuse or misuse of this product maximale de 300 psi des injecteurs sous pression peut entraîner un dysfonctionnement du or its repair by anyone other than an authorized Bard Access Systems, Inc. representative. cathéter et/ou le déplacement de son embout. 3

Attention, See Instructions For Use / Attention, voir le mode d’emploi / Achtung! Reorder Number / Code article / Bestellnummer / Numero di codice / Número para Gebrauchsanweisung beachten / Leggere attentamente le istruzioni per l’uso / Atención, pedidos / Bestelnummer / Número de encomenda / Αριθμός Νέας Παραγγελίας / consulte las instrucciones de uso / Raadpleeg de instructies voor gebruik / Atenção, Genbestillingsnummer / Beställningsnummer / Lisätilausnumero / Consulte as Instruções de Utilização / Προσοχή, Συμβουλευθείτε τις Οδηγίες Χρήσης / Etterbestillingsnummer/ Újrarendelési szám / Číslo doobjednávky / Numer katalogowy / Bemærk! Se brugsvejledningerne / Varning, se bruksanvisningarna / Huomio! Lue Tekrardan Sipariş Numarası / Номер повторного заказа / 재주문 번호 / 再訂購編號 käyttöohjeet. / OBS! Se bruksanvisningen/ Figyelem, lásd a használati útmutatót / Pozor, čtěte návod k použití / Uwaga, patrz Sposób użytkowania / Dikkat, Kullanım Talimatlarına bakınız / Внимание, смотрите инструкции по использованию / 주의, 사용 지침 참조. / 注意，請參閱使用說明 Lot Number / Numéro du lot / Chargennr. / Numero di lotto / Número de lote / Serienummer. / Número de Lote / Αριθμός Παρτίδας / Lot-nummer / Produktionsnr. / Eršnumero / Partinummer / Sorozatszám / Číslo šarže / Numer serii / Lot Numarası / Номер партии / 로트 번호 / 批號

Do Not Reuse / Ne Pas Réutiliser / Nicht Wiederverwenden / Non Riutilizzare / No Debe Reutilizarse / Niet Hergebruiken / Não Reutilizar / Απαγορέυεται η Επαναχρησιμοποίηση

/ Må Ikke Genbruges / Får Ej Återanvändas / Ei Saa Käyttää Uudelleen / Ikke for Gjenbruk / Nie Używać Ponownie / Csak Egyszer Használja / Nepoužívejte Opakovaně / Tekrar Use By / Date limite d’utilisation / Verfallsdatum / Data di scadenza / Utilizar antes de / Kullanmayın / ВНе подлежит повторному использованию / 재사용하지 마십시오. / Te gebruiken voor / Usar até / Χρήση Πριν / Anvendes inden / Använd före / Käytettävä 請勿重複使用 ennen / Brukes innen / Felhasználható / Použitelné do / Data ważności / Kullanan / Использовать до / 사용자 / 使用者

Length / Longueur / Länge / Lunghezza / Longitud / Lengte / Comprimento / Μήκος / Længde Do Not Resterilize / Ne pas restériliser / Nicht resterilisieren. / Non risterilizzare / No / Längd / Pituus / Lengde / Hosszúság / Délka / Długość / Uzunluk / Длина / 길이 / 長度 reesterilizar / Niet opnieuw steriliseren / Não reesterilizar / Να μην επαναποστειρωθεί / Må ikke resteriliseres / Får inte omsteriliseras / Älä steriloi uudelleen / Skal ikke resteriliseres / Nem újrasterilizálható / Nesterilizujte / Nie resterylizować / Tekrar Sterilize Etmeyiniz / Повторная стерилизация запрещена / 다시 멸균하지 마십시오. / 請勿重新消毒

Curved CurvedExtension Legs Extension Legs / Branches d’extension courbées / Gebogene Verlängerungen / Gambe di prolunga curve / Patas de extensión curvadas / Gebogen extensiepoten / Pernas com extensões curvas / Κυρτά σκέλη προέκτασης / Buede forlængerben / Böjda förlängningsben / Käyrät jatkohaarat / Kurvede forlengelsesben / Hajlított hosszabbítók / The Greendot / Point vert / Der Grüne Punkt / Numero Verde / El punto verde / De Groene Zakřivené prodlužovací nožky / Zakrzywione elementy przedłużające / Изогнутые удлинители Stip / Ponto Verde / Ανακυκλώσιμο / Svanemærket / Gröna punkten / Vihreä merkkipallo / Изогнутые удлинители / 곡선형 연장 레그 / 彎曲擴展腳 / Grønt punkt / Környezetbarát / Zelený bod / Produkt ekologiczny / Yeşil Nokta İşareti / Зеленая точка (символ вторсырья) / The Greendot / 綠點

After use, the catheter and accessories may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and all applicable laws and regulations. / Sterilized Using Ethylene Oxide / Stérilisé à l’oxyde d’éthylène / Sterilisiert mit Après utilisation, le cathéter et ses accessoires peuvent représenter un danger biologique Äthylenoxid / Sterilizzato con gas ossido di etilene / Esterilizado con oxido de etileno / potentiel. Il convient donc de les manipuler et de les éliminer conformément à la pratique Gesteriliseerd met ethyleenoxyde / Esterilizado por óxido de etileno / Αποστειρωμένος με médicale acceptée et aux lois et réglementations en vigueur. / Nach Verwendung birgt Οξείδιο του Αιθυλενίου / Steriliseret med ethylenoxid / Steriliserad med etylenoxid / der Katheter und das Zubehör ein Kontaminationsrisiko. Die weitere Behandlung und Steriloitu etyleenioksidilla / Sterilisert med etyloksid / Etilén-oxiddal sterilizálva / Entsorgung müssen gemäß etablierter medizinischer Praxis und unter Berücksichtigung Sterilizováno etylenoxidem / Sterylizowane tlenkiem etylenu / Etilen Okdit ile sterilize der zutreffenden Gesetze und Erlasse erfolgen. / Dopo l’uso, il catetere e gli accessori edilmiştir / Стерилизовано этиленоксидом. / 산화에틸렌으로 멸균 처리됨. / 采用环氧 possono rappresentare fonti di contaminazione biologica. Maneggiare ed eliminare 乙烷灭菌。 / 使用環氧乙烷消毒。 in conformità alle pratiche mediche correnti e alle normative e leggi locali e statali vigenti in materia. / Tras su uso, el catéter y sus accesorios pueden suponer un peligro potencial biológico. Manéjelo y deséchelo de acuerdo con la práctica médica habitual y las correspondientes leyes y regulaciones locales y nacionales. / Na gebruik kunnen de katheter en hulpstukken een potentieel besmettingsgevaar vormen. Behandel ze en werp ze weg op gangbare medische wijze en volgens alle van toepassing zijnde wetten DoSterile, not use if package is damaged. / Ne pas utiliser si l’emballage est endommagé. / en regels. / Após a utilização, o cateter e acessórios podem constituir potenciais bioriscos. Non-Pyrogenic Nicht verwenden, wenn die Verpackung beschädigt ist. / Non utilizzare se la confezione è Manuseie e elimine de acordo com a prática médica aprovada e com a legislação e Unless Package is regulamentos aplicáveis. / Μετά τη χρήση, ο καθετήρας και τα εξαρτήματά του είναι πιθανό Damageddanneggiata. or Opened. / No usar si el envase está dañado. / Niet gebruiken wanneer de verpakking beschadigd is. / Não utilizar se a embalagem estiver danificada. / Μην χρησιμοποιείτε το να αποτελούν δυνητικό βιολογικό κίνδυνο. Ο χειρισμός και η απόρριψή τους πρέπει να γίνονται προϊόν εάν η συσκευασία του έχει υποστεί ζημιά. / Må ikke anvendes, hvis emballagen er σύμφωνα με την αποδεκτή ιατρική πρακτική και τους ισχύοντες νόμους και κανονισμούς. / Efter beskadiget. / Använd inte produkten om förpackningen är skadad. / Älä käytä, jos pakkaus brug kan kateteret og tilbehøret udgøre en potentiel biologisk risiko. Det skal håndteres og bortskaffes i overensstemmelse med godkendt medicinsk praksis og med alle on vaurioitunut. / Må ikke brukes dersom pakningen er skadet. / A készüléket ne használja, gældende love og bestemmelser. / Efter användning ska kateter och tillbehör behandlas ha a csomagolása megsérült. / Nepoužívejte, pokud je obal poškozen. / Nie używać, som riskavfall. Hantera dem därför i enlighet med gällande lag, föreskrifter och praxis. / jeśli opakowanie jest uszkodzone. / Paket hasarlıysa kullanmayınız. / Не стерилизуйте Käytön jälkeen katetri ja muut välineet voivat olla tartuntavaarallisia. Niiden käsittelyssä повторно. / 포장이 손상된 경우 사용하지 마십시오. / 如 果 包 裝 損 壞，絕 不 可以 使 用。 ja hävittämisessä on noudatettava hyväksyttyjä lääkinnällisiä käytäntöjä sekä soveltuvia lakeja ja määräyksiä. / Etter bruk kan kateteret og tilbehøret være en mulig biologisk fare. Håndter og kasser i henhold til akseptert medisinsk praksis og alle gjeldende lover og vedtekter. / Használat után a katéter és a kellékek biológiailag veszélyesek lehetnek. Az elfogadott orvosi gyakorlatnak, valamint a vonatkozó törvényeknek kell kezelni és megsemmisíteni. / Katetr a doplňky představují po použití potenciální biologické riziko. Non-pyrogenic / Apyrogène. / Pyrogenfrei. / Apirogeno. / Apirógeno. / Niet-pyrogeen. / Používejte je a likvidujte jej v souladu se zavedenou lékařskou praxí a s příslušnými Apirogénico. / Μη πυρετογόνο. / Pyrogenfri. / Icke-pyrogen. / Pyrogeeniton. / Pyrogenfri. / státními a federálními zákony a předpisy. / Po użyciu cewnik i akcesoria stwarzają Nem pirogén. / Apyrogenní. / Produkt niepirogenny. / Pirojenik değildir. / Однократное potencjalnie zagrożenie biologiczne. Należy obchodzić się z nimi i pozbyć się zgodnie z использование. / 비발열성. / 無熱原。 przyjętą praktyką medyczną oraz obowiązującymi przepisami i regulacjami. / Kullanımdan sonra kateter ve eklentileri gizil biyolojik tehlike içerebilir. Ürünü yalnızca yerleşik tıbbi uygulamalara uygun ve geçerli yasa ve yönetmelikleri dikkate alan bir biçimde kullanıp Rx Only atınız. / После использования данное изделие может представлять потенциальную биологическую опасность. Обращайтесь и утилизируйте в соответствии с принятой Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. медицинской практикой и всеми действующими законами и постановлениями. / / La loi fédérale (E.-U.) n’autorise la délivrance de ce système qu’à un médecin ou sur 사용한 후 카테터와 부속품은 생물학적으로 위험할 수 있습니다. 용인되는 의료 prescription d’un médecin. / Gemäß den US-Bundesgesetzen darf dieses Produkt nur von 관행 및 모든 해당 법과 규정에 따라 취급 및 폐기하십시오. / 使用後導管及附件可能 einem Arzt oder auf Anordnung eines Arztes verkauft werden. / In base alla legge federale 是潛在的生物危害。請根據公認的醫療實踐和所有適用法律法規處理和丟棄。 (U.S.A.) La vendita di questo dispositivo è consentita solo da parte o su prescrizione di un medico. / La ley federal (EE.UU.) limita la venta de este dispositivo, que debe ser realizada por un médico opor prescripción facultativa. / Krachtens de federale wetgeving (VS) mag dit instrument uitsluitend door of op voorschrift van een arts worden verkocht. / As Leis This product and packaging do not Federais dos E.U. determinam que este dispositivo seja vendido somente por médicos contain natural rubber latex. ou por ordem destes. / Τo Ομoσπoνδιακό Δίκαιo των Η.Π.Α. περιορίζει την πώληση από γιατρούς γιατρού. / Føderal lov i USA begrænser denne anordning til salg af eller på This product and packaging do not contain natural rubber latex. / Ce produit et bestilling af en læge. / Enligt federal lagstiftning (USA) får denna produkt säljas endast son emballage ne contiennent aucune trace de latex en caoutchouc naturel. / Dieses av läkare eller enligt läkares ordination. / Yhdysvaltain lain mukaan tätä tuotetta saa Produkt und die Verpackung enthalten kein Naturlatex. / Il prodotto e la confezione non myydä vain lääkäri tai lääkärin määräyksestä. / Etter amerikansk lovgivning kan dette contengono lattice di gomma naturale. / Este producto y su embalaje no contienen látex utstyret kun selges eller ordineres av en lege. / Ezen eszköz kizárólag orvos által, illetve de goma natural. / Dit product en de verpakking bevatten geen natuurlijke rubberlatex. / orvosi rendelvényre értékesíthető, az Egyesült Államok vonatkozó szövetségi törvénye Este produto e respectiva embalagem não contêm látex de borracha natural. / To παρόν értelmében. / Federálni zákony USA omezují prodej tohoto zařízení jen na prodej na πρoϊόν και η συσκευασiα δευ περιέχoυν λάτεξ από φυσικό καουτσούκ. / Dette produkt objednávku lékaře. / Zgodnie z prawem federalnym (w USA) urządzenie to może być indeholder ikke naturgummilatex. / Denna produkt och förpackning innehåller inte sprzedawane wyłącznie przez lekarzy lub na ich zlecenie. / A.B.D. Federal Yasalarına göre naturligt gummilatex. / Tämä tuote ja sen pakkaus eivät sisällä luonnonkumilateksia. / bu cihaz bir hekim tatafından veya izniyle satılabilir. / Pirojenik değildir. / Федеральный Dette produktet og emballasjen inneholder ikke naturlig gummilateks. / Ez a termék закон США разрешает продажу данного устройства только врачам или по рецепту és csomagolása nem tartalmaz természetes gumilatexet. / Výrobek a obal neobsahují врача. / 미 연방법은 이 기구의 판매를 의사가 직접, 또는 의사의 주문에 의한 것으로 prírodní kaucukový latex. / Produkt i opakowanie nie zawieraja kauczuku lateksu 제한하고 있습니다. / 聯邦（美國）法律規定本設備僅限醫師銷售或訂購。 naturalnego. / Bu ürün ve ambalaj, dogal lastik lateks içermez. / Данное изделие и его упаковка не содержат натурального латекса. / 이 제품 및 포장에는 천연 고무 라텍스가 함유되어 있지 않습니다. / 本產品和包裝不含天然橡膠乳膠。

This product and Contents / Contient: / Inhalt / Contenuto / Contenido / Inhoud / Conteúdo / Περιεχόμενα packaging do not contain DEHP / Indhold / Innehåll / Sisältö / Innhold / Tartalom / Obsah / Zawartość / Içindekile / Содержимое / 내용물 / 內容 This product and packaging do not contain DEHP / Ne contient pas de DEHP / Enthält kein DEHP / Non contiene DEHP / No contienen DEHP / Bevat geen diethylhexylftalaat (DEHP) / Não contém DEHP / Δεν περιέχει DEHP / Indeholder ikke DEHP / Innehåller ej DEHP / Ei sisällä DEHP:tä / Inneholder ikke DEHP / Nem tartalmaz DEHP-t (dietil-hexil-ftalátot) / Neobsahuje DEHP / Nie zawiera DEHP / DEHP içermez / Данное изделие и его упаковка не содержат диэтилгексилфталата / 이 제품 및 Manufacturer / Fabricant / Hersteller / Produttore / Fabricante / Fabrikant / Fabricante 포장에는 DEHP가 들어 있지 않습니다. / 本產品和包裝不含 DEHP / Кατασκευαστής / Producent / Tilverkare / Valmistaja / Produsent / Gyártó / Výrobce / Producent / Űretici / Изготовитель / 제조업체 / 製造商

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