• Before dialysis begins, all connections to the extracorporeal circuit must be checked carefully. During all dialysis procedures frequent
visual inspection must be conducted to detect leaks and prevent blood loss or entry of air into the extracorporeal circuit. Excess blood
leakage may lead to patient shock.
• In the rare event of a leak, the catheter must be clamped immediately. Necessary remedial action must be taken prior to
resuming dialysis procedure.
• If the catheter is not used immediately for treatment, follow the suggested Catheter Patency Guidelines.
• Failure to clamp extensions when not in use may lead to air embolism.
• Verification of the catheter tip location must be confirmed by x-ray to ensure proper placement.
• For optimal product performance and to avoid complications, do not insert any portion of the curve into the vein.
• To prevent systemic heparinization of the patient, the heparin solution must be aspirated out of both lumens
immediately prior to using the catheter.
• For jugular and subclavian insertion, the patient must be placed on a cardiac monitor during this procedure. Cardiac arrhythmia may
result if the guidewire is allowed to pass into the right atrium. The guidewire must be held securely during the procedure.
8
• The risk of infection is increased with femoral vein insertion.
• Recirculation in femoral catheters was reportedly significantly greater than in internal jugular catheters.
• Before attempting the insertion of the catheter, ensure that you are familiar with the possible complications
listed below and their emergency treatment should they occur.
• Cannulation of the left internal jugular vein was reportedly associated with higher incidence of complications
compared to catheter placement in the right internal jugular vein.
4
• 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.
CHLORAPREP* SOLUTION ONE-STEP APPLICATOR WARNINGS
• Flammable, keep away from fire or flames.
• Do not use with electrocautery procedures.
• For external use only.
• When using this product keep out of eyes, ears, and mouth. May
cause serious or permanent injury if permitted to enter and remain.
If contact occurs, rinse with cold water right away and contact a physician.
• Stop use and ask doctor if irritation, sensitization, or allergic
reaction occurs. These may be signs of a serious condition.
• Keep out of reach of children. If swallowed, get medical help or
contact a poison control center right away.
PRECAUTIONS:
• Rx Only - Federal (USA) law restricts this device to sale by or on the order of a physician.
•
Carefully read and follow all instructions prior to use.
• Only qualified health care practitioners should insert, manipulate and remove these devices.
• Strict aseptic technique must be used during the insertion, maintenance and catheter removal procedures.
• Do not pull back guidewire over needle bevel as this may sever the end of the guidewire. The introducer needle must be removed first.
Also, if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the cause of resistance
before proceeding. Withdraw needle and guidewire if cause of resistance cannot be determined.
• Do not allow the guidewire to inadvertently advance totally into the vessel.
• For jugular and subclavian insertion, the catheter tip should not be located in the right atrium.
• Left sided placement in particular, may provide unique challenges due to the right angles formed by the innominate vein
and at the left brachiocephalic junction with the SVC.
5,6
POSSIBLE COMPLICATIONS
The use of an indwelling central venous catheter provides an important means of venous access for critically ill patients; however, the potential exists
for serious complications including the following:
• Air Embolism
• Arterial Puncture
• 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 Between the Clavicle
and First Rib
1
• Catheter-Related Sepsis
• Endocarditis
• Exit Site Infection
• Exit Site Necrosis
• Extravasation
• Fibrin Sheath Formation
• Hematoma
• Hemomediastinum
• Hemothorax
• Hydrothorax
• Inflammation, Necrosis or Scarring of Skin
Over Implant Area
• Intolerance Reaction to Implanted Device
• Laceration of Vessels or Viscus
• Perforation of Vessel or Viscus
• Phlebitis
• Pneumothorax
• Spontaneous Catheter Tip Malposition
or Retraction
• Thoracic Duct Injury
• Thromboembolism
• Venous Stenosis
• Venous Thrombosis
• Ventricular Thrombosis
• Vessel Erosion
• Risks Normally Associated with Local
and General Anesthesia, Surgery, and Post-
operative Recovery
These and other complications are well documented in medical literature and must be carefully considered before placing the catheter. Placement
and care of the catheters must be performed only by persons knowledgeable of the risks involved and qualified in the procedures.
INSTRUCTIONS FOR CATHETER INSERTION
1. The catheter must be inserted only under strict aseptic conditions. For Jugular or Subclavian insertion, the patient must be in a modified
Trendelenburg position, with the head turned to the side opposite that of the insertion site. A small rolled towel may be inserted between the
shoulder blades. For Femoral insertion, place patient in supine position to expose the side of the groin to be accessed.
2. Prepare the access site using standard surgical technique and drape the prepped area. If hair removal is necessary, use clippers or depilatories.
Next, scrub the entire area preferably with chlorhexidine gluconate unless contraindicated in which case povidone–iodine may be used. If using
the ChloraPrep* Solution One-Step Applicator perform skin preparation using the following steps:
• Prepare the site with the ChloraPrep* Solution One-Step Applicator or
according to institution protocol using sterile technique.
• Pinch the wings of the ChloraPrep* Solution One-Step Applicator to
break the ampule and release the antiseptic. Do not touch the sponge.
• Wet the sponge by repeatedly pressing and releasing the sponge
against the treatment area until fluid is visible on the skin.
• Use repeated back-and-forth strokes of the sponge for at least 30
seconds. Completely wet the treatment area with antiseptic. Allow the
area to dry for approximately 30 seconds. Do not blot or wipe away.
• Maximum treatment area for one applicator is approximately 130 cm
2
(approximately 4 x 5 in.). Discard the applicator after a single use.
• Remove and discard gloves.
CHLORAPREP* SOLUTION ONE-STEP APPLICATOR WARNINGS
• Flammable, keep away from fire or flames.
• Do not use with electrocautery procedures.
• For external use only.
• When using this product keep out of eyes, ears, and mouth. May
cause serious or permanent injury if permitted to enter and remain.
If contact occurs, rinse with cold water right away and contact a
physician.
• Stop use and ask doctor if irritation, sensitization, or allergic reaction
occurs. These may be signs of a serious condition.
• Keep out of reach of children. If swallowed, get medical help or contact
a poison control center right away.
3. Prepare a sterile field throughout the procedure. The operator should wear a cap, mask, sterile gown, sterile gloves, and use
a large sterile drape to cover the patient.
4. The insertion site is identified. A local anesthetic is injected over the site.
5. A syringe is attached to an introducer needle that will permit passage of a 0.035 inch (0.89 mm) guidewire.
6. The introducer needle is inserted into the identified vein.
7. The syringe is removed leaving the introducer needle in place.
WARNING: For jugular and subclavian insertion, the patient must be placed on a cardiac monitor during this procedure.
Cardiac arrhythmia may result if the guidewire is allowed to pass into the right atrium. The guidewire must be held securely during the procedure.
8. The flexible end of a guidewire is inserted through the introducer needle into the vein.
CAUTION: Do not pull back guidewire over needle bevel as this may sever the end of the guidewire. The introducer needle must be
removed first. Also, if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the
cause of resistance before proceeding. Withdraw needle and guidewire if cause of resistance cannot be determined.
9. Holding the guidewire securely in place, remove the introducer needle. CAUTION: Do not allow the guidewire to
inadvertently advance totally into the vessel.
10. The introducer needle tract is widened by creating a small surgical incision at the skin exit site. The incision should be slightly
larger than the wide/flat side of the catheter.
11. Use the Dualator* vessel dilator(s) to dilate the subcutaneous tissues. Dilate 2-3 times with slow, gradual advancements. The larger portion
of the Dualator* dilator device must enter the vein prior to catheter insertion.
12. Flush each lumen with heparinized saline prior to insertion and clamp the arterial (red) lumen.
13. The venous clamp must be in the open position to allow the catheter to pass completely over the wire and into the vein.
14. The dual lumen catheter is passed over the proximal end of the guidewire by inserting the
guidewire tip into the tapered end of the catheter. Insert the catheter flat side to the skin.
15. Pinch guidewire and the catheter together, advance together in 5 to 10 cm increments (retract wire as needed). Do not
twist the catheter during over-the-guidewire insertion.
16. The depth markings in one cm increments may be used to determine insertion depth.
17. The catheter tip should be in the lower superior vena cava for optimal performance. If placed femorally, the catheter tip should be placed in the
inferior vena cava to minimize recirculation.
8
CAUTION: For jugular and subclavian insertion, the catheter tip must be located above the junction of the superior vena
cava and right atrium. WARNING: Verification of the catheter tip location must be confirmed by x-ray.
18. The guidewire is removed, and the venous clamp is closed. Both lumens are irrigated again
with heparinized saline filled syringes. (It is necessary to open the extension clamps during the irrigation procedure). Both
the arterial and venous clamps are now closed and the injection caps are placed over the ends of each Luer-lock connector
on the extension pieces.
19. The rotatable, pre-attached suture wing is oriented to the skin surface and the catheter is attached using suture.
20. When placing the catheter, use the removable suture wing to minimize movement at the exit site. I.) Using your fingers,
squeeze the suture wing together so that it splits open and place the wing around the catheter near the venipuncture site.
II.) Secure the wing onto the catheter by tying sutures around the wing using the suture grooves. III.) Secure the removable
wing in place by suturing through the holes or by using adhesive wound closures. WARNING: For optimal product
performance and to avoid complications, do not insert any portion of the curve into the vein.
21. A sterile adhesive transparent dressing is used to cover the skin exit site.
22. The catheter is now ready for use. For hemodialysis, hemoperfusion, or apheresis the arterial lumen of the catheter is connected to the arterial
side of the extracorporeal circuit. The venous lumen of the catheter is connected to the venous side of the extracorporeal circuit.
CATHETER PATENCY GUIDELINES
1. Flush arterial and venous lumens with a minimum of 10 mL of sterile saline using a 10 mL or larger syringe.
WARNING: To avoid damage to vessels and viscus, infusion pressures whould not exceed 25 psi (172 kPA). The use of a 10 mL or
larger syring is recommended because smaller syrings generate more pressure than larger syringes.
2. Inject heparin solution into each lumen in amounts equal to the priming volumes as printed on the catheter clamps. Be sure to clamp
each lumen immediately and attach end caps. WARNING: Failure to clamp extensions when not in use may lead to air embolism.
3. For additional security, suture the entry site to anchor the catheter.
4. Follow your hospital protocal for dressing change and exit site care. Allow alcohol-containing agents (e.g., Chrolaprep
1
solution)
to air dry completely before dressing the catheter.
WARNING: Acetone and Polyethylene Glycol (PEG) - containing ointments can cause failure of this device and should not be used
on polyurethane catheters. Chlorhexidine patches or bacitracin zinc ointments (e.g., Polysporin* ointment) are the preferred alternative.
5. Verify the catheter tip location with x-ray or fluoroscopy.
PERFORMANCE GUIDELINES: Flow rate vs venous pressures
†
† As suggested by
In vitro data
, using a blood simulate approximating the viscosity of whole blood.
CARE AND MAINTENANCE
The care and and maintenance of the catheter requires well trained, skilled personnel following a detailed protocol. The protocol should
include a directive that the catheter is not to be used for any purpose other than the prescribed therapy.
Accessing Catheter, Cap Changes, Dressing Changes
8
• Experienced personnel
• Use aseptic technique
• Proper hand hygiene
• Clean gloves to access catheter and remove dressing and sterile gloves for dressing changes
• Surgical mask (1 for the patient and 1 for the healthcare professional)
• Catheter exit site should be examined for signs of infection and dressings should be changed at each dialysis treatment or per
hospital policy.
• 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.
• Carefully remove the dressing and inspect the exit site for inflammation, swelling and tenderness. Notify physician immediately if
signs of infection are present.
Exit Site Cleaning
9
• Use aseptic technique (as outlined above).
• Clean the exit site at each dialysis treatment with chlorhexidine gluconate unless contraindicated. Apply antiseptic per manufacturer’s
recommendations. Allow to air dry completely.
• Cover the exit site with sterile, transparent, semipermeable dressing or per hospital protocol.
Recommended Cleaning Solutions
Catheter Luer-lock Connectors/End Caps:
• Povidone iodine (allow connectors/end caps to soak for
3 to 5 minutes)
6
WARNING: Alcohol should not be used to lock, soak or declot
polyurethane Dialysis Catheters because alcohol is known to
degrade polyurethane catheters over time with repeated and
prolonged exposure.
Hand cleaner solutions are not intended to be used for disinfecting
our dialysis catheter Luer-lock connectors.
Exit Site:
• Chlorhexidine gluconate 2% solution (preferred)
7, 8, 9, 10, 11
• Chlorhexidine gluconate 4% solution
• Dilute aqueous sodium hypochlorite
• 0.55% sodium hypochlorite solution
• Povidone iodine
• Hydrogen peroxide
• Chlorhexidine patches
• Bacitracin zinc ointments in petrolatum bases
WARNING: Acetone and Polyethylene Glycol (PEG)-containing
ointments can cause failure of this device and should not be used with
polyurethane catheters. Chlorhexidine patches or bacitracin zinc oint-
ments (e.g., Polysporin* ointment) are the preferred alternative.
Flow Rate vs Lumen Pressure (400 mL/min Flow Rate)
30 cm Straight
24 cm Curved Extension
Venous (mm Hg)
226
193
Arterial (mm Hg)
-231
-195
