12275967 IFU_361-19901 12/13/11 10:25 AM Page 5
RC081195-2
McGaw Park, IL
Richard Cisneroz
12-07-11
12275967
The pinch clamp must be fully closed to occlude the
drainage line. When not connected to a suction
source, make sure the pinch clamp is fully closed.
Otherwise, the drainage line may allow air into the
body or let fluid leak out.
When connecting to a vacuum bottle, make sure the
pinch clamp on the drainage line is fully closed.
Otherwise, it is possible for some, or all of the
vacuum in the bottle to be lost.
When draining with glass vacuum bottles, do not
use a needle larger than 17 G. If wall suction is used,
it must be regulated to no greater than
(-)60 cm H
O, or to drain no more than 400 ml
2
of fluid per minute.
Keep the valve on the PleurX Catheter and the
lockable access tip on the drainage line clean. Keep
them away from other objects to help avoid
contamination.
Make sure that the valve and lockable access tip are
securely connected when draining. If they are
accidentally separated, they may become
contaminated. If this occurs, clean the valve with an
alcohol pad and use a new drainage set to avoid
potential contamination.
Precautions should be taken to ensure the drainage
line is not tugged or pulled.
It is normal for the patient to feel some discomfort
or pain when draining fluid. If discomfort or pain is
experienced when draining, clamp the drainage line
to slow or stop the flow of fluid for a few minutes.
Pain may be an indication of infection.
Potential complications of access and drainage of
the peritoneal cavity include, but may not be limited
to, the following: laceration of liver or bowel,
hypotension/circulatory collapse, electrolyte
imbalance, protein depletion, ascites leakage,
peritonitis, wound infection, tumor growth in the
catheter tunnel, and loculation of the peritoneal
cavity.
Removal of chylous malignant ascites could
exacerbate protein depletion or related nutritional
complications.
Sterility
This product has been sterilized. It is for single use
only and is not to be resterilized. Do not use if
package is damaged. CareFusion will not be
responsible for any product that is resterilized, nor
accept for credit or exchange, any product that has
been opened but not used.
General Guidelines
1. Systemic prophylactic antibiotics may be
indicated.
2. The procedure for peritoneal placement can be
performed using local anesthetic and sedation.
However, depending on patient needs, it may be
performed using alternative approaches to
anesthesia or sedation.
Proofed by:
Dimensions checked:
3. The catheter should be placed under image
guidance, using all precautions normally used for
percutaneous placement of indwelling, tunneled
catheters. Care should be taken to identify and
avoid contact with vasculature near the guidewire
insertion site.
4. Guidewire insertion site selection should be
based upon patient anatomy and presentation
with consideration given to any possible
adhesions or loculated pockets of fluid. The
fenestrated section of the catheter should
preferentially be placed low in the peritoneal
cavity to maximize access to fluid.
5. Consideration should be given to the patient's
ease of access in determining the location of the
catheter exit site.
Suggested Placement Procedure
External Portion
of Catheter
Second Incision:
Catheter Exit
Site
Tunneled
First Incision:
Portion of
Guidewire
Catheter
Insertion Site
Proper medical and surgical procedures are the
responsibility of the physician. The appropriateness
of any procedure must be based upon the needs of
the patient. Diagram (3) illustrates the placement of
the PleurX Peritoneal Catheter, as described in the
following procedure.
Caution: Individual patient anatomy, such as thin or
weak abdominal wall, may require procedural
variations to reduce the risk of leakage around the
catheter.
1. Position the patient appropriately to access the
desired guidewire insertion site.
2. Identify the appropriate insertion site through
which to place the guidewire. The guidewire
insertion site is typically lateral to the midline,
6 –10 cm below the costal margin, and above
the patient's beltline. Ultrasound can be used to
confirm the guidewire insertion site.
3. Identify the location of the catheter exit site,
which is usually 5-8 cm superior and medial to
the guidewire insertion site.
4. Surgically prep the patient.
5. Drape and anesthetize the planned insertion and
tunneling sites.
2
Date:
Copy checked: