CareFusion PleurX 50-7050 Manual Del Usuario página 5

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PleurX™ Pleural Catheter Procedure
Product Information
The PleurX™ Pleural Catheter consists of a
fenestrated silicone catheter with a valve mechanism
and a polyester cuff. A barium sulfate stripe runs the
entire length of the catheter. (Figure 1) The valve is
designed to prevent the passage of air or fluid in
either direction unless it is accessed with the
specifically matched drainage line, access kit, or
vacuum bottles provided by CareFusion. The PleurX™
Pleural Catheter is designed exclusively for use with
the PleurX™ Vacuum Bottles, glass vacuum bottles,
and the Lockable Drainage Line for connection to
wall suction or portable suction.
PleurX™ Pleural Catheter
Fenestrations
25.5 cm
Internal Portion
Catheter: 66.0 cm
(1)
Lockable Drainage Line
Lockable Access Tip
Drainage Line: 61 cm
(2)
Indications for Use
The PleurX™ Pleural Catheter Mini Kit is indicated for
intermittent, long term drainage of symptomatic,
recurrent, pleural effusion, including malignant pleural
effusion and other recurrent effusions that do not
respond to medical management of the underlying
disease. The devices are indicated for the palliation of
dyspnea due to pleural effusion and providing
pleurodesis (resolution of the pleural effusion). The
PleurX™ Pleural Catheter is indicated for adults only.
The Lockable Drainage Line (Figure 2) is used to
drain fluid using standard wall suction, water seal
drainage system, vacuum bottle, or other appropriate
method.
Contraindications
Use of the PleurX™ Pleural Catheter Mini Kit is
contraindicated in the following situations:
1. When there is a shift > 2 cm in the mediastinum
towards the ipsilateral side of the effusion.
2. When the pleural cavity is multi-loculated, and the
drainage of a single loculation would not be
expected to provide relief of dyspnea.
3. When there is a coagulopathy.
4. When the pleural cavity is infected.
5. When the effusion is known to be chylous.
6. When the patient is known or suspected to be
allergic to materials contained in the device.
Polyester
Cuff
Valve
12.5 cm 28 cm
External Portion
Roller Clamp
Luer Lock
Warnings
Do not put anything except the access tip of the
Lockable Drainage Line, Catheter Access Kit, or
PleurX™ Vacuum Bottles into the catheter valve since
any other device could damage the valve. A damaged
valve may allow air into the body or let fluid leak out
through the valve when not draining.
Do not place the PleurX™ Pleural Catheter into the
peritoneal space as it could lead to misidentification
of the catheter and/or mistreatment of the patient.
Cautions
For single use only. Re-use may result in a
non-functional product or contribute to cross
contamination.
Sterile technique should be used when placing and
draining the catheter.
Exercise care when placing the catheter to prevent it
from coming into contact with surfaces such as
drapes or towels. Silicone rubber is highly
electrostatic and attracts airborne particles and
surface contaminants.
The fenestrations must be entirely within the pleural
space to avoid leakage into the tunnel tract. Take
patient size, tunnel length, and the catheter length
into account when placing the catheter.
Individuals with severe skin pathology overlying the
favored implantation site (e.g. tumor
invasion/psoriasis) should receive alternative
treatment to relieve symptoms.
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.
PleurX™ Catheter Tray Supplies
Placement Components
1 PleurX™ Pleural Catheter, 15.5 Fr
1 Guidewire Introducer with Needle
1 Syringe, 10 ml
1 J-Tip Guidewire
1 Peel-Away Introducer, 16 Fr
1 Tunneler
1 Needle Foam Stop
1 Blue Wrap
Drainage Components
1 Drainage Line with Lockable Access Tip
1 Needle, 17 G x 1" (2.5 cm)
1 5-in-1 Drainage Line Adapter
1 Valve Cap
Dressing Components
6 Gauze Pads, 4" x 4" (10.2 cm x 10.2 cm)
1 Foam Catheter Pad
1 Self-Adhesive Dressing
1