POST DIALYSIS
1.
To maintain patency between treatments a heparin lock must be created in each lumen of the catheter.
2.
Inject 5000 units of heparin per ml. of saline (or a concentration approved by your institution) into each lumen in amounts equal to
the priming volume of each lumen. To ensure that each lumen is totally filled, inject vigorously and clamp extension while under
positive pressure. Attach a sterile injection cap to each clamping extension.
WARNING: The heparin solution must be aspirated out of both lumens immediately prior to using the catheter to prevent
systemic heparinization of the patient.
CARE AND MAINTENANCE
1.
The care 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.
2.
The exit site should be checked daily. Sterile technique, including facemask, hand washing and sterile gloves must be used for
these procedures.
3.
Carefully remove the dressing and inspect the exit site for inflammation, swelling and tenderness. Notify physician immediately if
signs of infection are present.
4.
Clean the exit site with an antimicrobial solution following your institution’s protocol. Clean from the catheter working outward in a
circular motion.
5.
WARNING: Acetone and PEG-containing ointments can cause failure of this device and should not be used with
polyurethane catheters. Chlorhexidine patches are the preferred alternative.
6.
Dress the catheter as described above under “D (Common Steps).”
TROUBLESHOOTING
PATIENT WITH FEVER
Unusual signs or symptoms (i.e. fever, chills) occurring immediately following the procedure may indicate septic thrombosis. If this does
result, the catheter should be removed.
INSUFFICIENT FLOW
Excessive force should not be used to flush an obstructed lumen. Insufficient blood flow may be caused by occluded arterial tip resulting
from a clot or by contacting the wall of the vein. If manipulation of the catheter through or reversing arterial and venous lines does not
help, then the physician may attempt to dissolve the clot with a thrombolytic agent (i.e. TPA). Physician discretion advised.
CATHETER EXCHANGE
It may become necessary to exchange the indwelling catheter due to infection or a persistent rise in pressures or decrease of flow rates
which cannot be rectified through troubleshooting.
REFERENCES:
1 Aitken, D.R. and Minton, J.P. “The Pinch-Off Sign: A Warning of Impending Problems with Permanent Subclavian Catheters”, American
Journal of Surgery, Vol. 148, Nov. 1984, pp.633-638.
2 Mickley, V., “Central venous catheters: many questions: few answers”, Nephrol Dial Transplant, (2002) 17:1368-1373.
3 National Kidney Foundation K/DOQI GUIDELINES 2000.
4 Sulek, CA., Blas, ML., Lobato, EB “A randomized study of left versus right internal juglar vein cannulation in adults.”
J Clin Anesth. 2000 Mar;12(2):142-5.
5 Tan, P.L., Gibson, M., “Central Venous Catheters: the role of radiology”, Clin Rad. 2006, 61:13-22.
6 Octavio, Bella, Colemenares, Garcia, and Flores; “Right Versus Left Internal Vein Catheterization for Hemodialysis: Complications and
Impact on Ipsilateral Access Creation”; Artifical Organs; 2004 28(8):728-733.
Other references available upon request.
An issued or revision date for these instructions is included for the users information. In the event two years have elapsed between this
date and product use, the user should contact Bard Access Systems, Inc. to see if additional product information is available. Revision
date: December, 2007
Covered by one or more of the following U.S. Patents: 5,156,592; 5,366,444.
*Bard, Soft-Cell, Trigger and Split-Kit are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate.
© Copyright 2007
All rights reserved.
Bard Access Systems, Inc.
Salt Lake City, UT 84116 U.S.A.
1-801-595-0700
Customer Service: 800-545-0890
Clinical Information: 800-443-3385
www.bardaccess.com
PK0713597 / 0712R
Performance Guideline: Flow Rate vs Lumen Pressure
Soft Cell
*
Catheter (19cm. STR)
300 ml/min
Venous
178 mmHg
Arterial
-215 mmHg
Priming Volumes
Insertion
Arterial
Venous
Length (cm)
Volume (ml)
Volume (ml)
Sraight
12
1.4
1.4
19
1.6
1.7
Pre-Curved
12 PC & PC-2
1.4
1.4
15 PC-2
1.5
1.6
17 PC-2
1.6
1.6
19 PC
1.6
1.7
19 PC2
1.7
1.7
23 PC & PC-2
1.8
1.8
DESCRIPTION
The straight and pre-curved polyurethane catheter with white retention cuff is divided into two separate lumens by a septum allowing
hemodialysis without the use of a “single needle” system.
CAUTION: STERILE AND NON-PYROGENIC ONLY IF PACKAGING IS NOT OPENED, DAMAGED OR BROKEN.
STERILIZED WITH ETHYLENE OXIDE.
SINGLE PATIENT USE ONLY.
Read the instructions for use carefully before using this device.
CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
INDICATIONS FOR USE
The Soft-Cell* dual lumen hemodialysis catheter is indicated for use in attain-
ing short-term or long-term vascular access for hemodialysis, hemoperfusion or
apheresis therapy via the jugular or subclavian vein.
WARNING: Percutaneous insertion of the catheter should be made into the
axillary-subclavian vein at the junction of the outer and mid-thirds of the clavicle
lateral to the thoracic outlet. The catheter should not be inserted into the sub-
clavian vein medially, because such placement can lead to compression of the
catheter between the first rib and clavicle and can lead to damage or fracture
and embolization of the catheter.
1
Fluoroscopic or radiographic confirmation of
catheter tip placement should be helpful in demonstrating that the catheter is
not being pinched by the first rib and clavicle.
1
WARNINGS
•
Acetone and PEG-containing ointments can cause failure of this device and should not be used with polyurethane
catheters. Chlorhexidine patches are the preferred alternative.
•
Alcohol or acetone based solutions should not be used to clean the catheter or skin site as the clamping extensions and luer lock
connectors may be adversely affected.
•
Do not resterilize the catheter or components by any method. The manufacturer will not be liable for any damages caused by re-
use of the catheter or accessories.
•
Place all clamps only in the center of the polyurethane extension pieces. Polyurethane may develop cuts or tears if subjected to
excessive pulling or contact with rough edges. Repeated clamping near or on the luer lock connectors may cause tubing fatigue
and possible disconnection.
•
To avoid damage to vessels and viscus, infusion pressures should 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. Note: A three pound force (13.3
N) on the plunger of a 3 ml syringe generates pressure in excess of 30 psi (206 kPa) whereas the same three pound force (13.3N)
on the plunger of a 10 ml syringe generates less than 15psi (103 kPa) of pressure.
•
Follow Universal Precautions when inserting and maintaining this device.
•
Accessories and components used in conjunction with this catheter should incorporate luer-lock adapters.
•
Catheters should be implanted carefully to avoid any sharp or acute angles which could compromise the opening of the catheter
lumens.
•
To prevent air embolism and/or blood loss, place thumb over the exposed orifice of the sheath introducer.
•
The heparin solution must be aspirated out of both lumens immediately prior to using the catheter to prevent systemic hepariniza-
tion of the patient.
•
Failure to clamp extensions when not in use may lead to air embolism.
•
In the rare event of a leak, the catheter should be clamped immediately. Necessary remedial action must be taken prior to resum-
ing dialysis or infusion procedure.
•
Do not allow the guidewire to further advance into the vein. Cardiac arrythmias may result if the guidewire is allowed to pass into
the right atrium.
•
Cannulation of the left internal jugular vein was reportedly associated with a higher incidence of complications compared to catheter
placement in the right internal jugular vien.
4
CAUTION
•
Repeated over tightening of blood lines, syringes and caps will reduce connector life and could lead to potential connector failure.
In case of damage, clamp the catheter between the patient and the damaged area with a smooth-edged, atraumatic clamp.
•
Left sided placement in particular, may provide unique challeges due to the right angles formed by the innominate vein and at the
left brachiocephalic junction with the SVC.
2,5
•
Care should be taken NOT to force the dilator shealth introducer assembly into the vessel during insertion as vessel damage
including perforation could result.
•
Before attempting the insertion of Soft-Cell* catheters, ensure that you are familiar with the following complications and their emer-
gency treatment should any of them occur.
Soft-Cell
*
Dual Lumen Catheter
Instructions For Use
For Soft-Cell* Straight and Precurved (PC) Catheters
Access Systems
First Rib
Subclavian Vein
Clavicle
Vertebra
Internal Jugular Vein
Superior Vena Cava
Sternum
Pinch-off Area
Infraclavicular Fossa
Axillary Vein