COOK Medical wayne Instrucciones De Uso página 3

WAYNE PNEUMOTHORAX SET
For Seldinger Placement
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The modified Wayne Pneumothorax Set, for Seldinger placement, consists
of access needle(s), stainless steel wire guide, appropriately sized dilator,
radiopaque polyurethane catheter, polyvinylchloride connecting tube, plastic
three-way stopcock, and latex-free Cook Chest Drain Valve to be used for
evacuation of air or fluid.
INTENDED USE
The modified Wayne Pneumothorax Set is intended for relief of simple,
spontaneous, iatrogenic and tension pneumothorax.
CONTRAINDICATIONS
Not recommended for large fluid accumulation or hemothorax.
WARNINGS
None known
PRECAUTIONS
• This product is intended for use by physicians trained and experienced in
the treatment of a pneumothorax. Standard techniques for placement of
pneumothorax catheters should be employed.
• Ensure stopcock is in the ON position to the valve to prevent aspiration of air.
• Lung puncture may result in an air embolus, which could lead to ischemia
or infarction of major organs, including the brain or cardiac system.
• The potential effects of phthalates on pregnant/nursing women or
children have not been fully characterized and there may be concern for
reproductive and developmental effects.
INSTRUCTIONS FOR USE
1. Prep the access site with appropriate antiseptic solution and drape
in standard fashion. NOTE: The suggested insertion site is the fourth
intercostal space at the anterior or mid-axillary line.
2. Introduce local anesthesia through skin and subcutaneous tissue down to
pleura. Make an incision through skin only. Anesthesia may be omitted
in an emergency decompression.
3. Insert the introducer needle through the incision into the pleural cavity.
4. When the needle tip enters the pleural cavity, introduce the flexible end of
the wire guide into the needle 10-15 cm.
5. Remove the needle, leaving wire guide in place.
6. Advance dilator over the wire guide to achieve desired dilation. Remove
dilator, being careful to maintain wire guide position.
7. Attach plastic three-way stopcock to the catheter obturator. Fully straighten
the curved catheter tip by advancing the catheter obturator. When fully
advanced, attach the obturator to the catheter via the luer lock connection.
8. Advance the catheter over the wire guide into the pleural cavity to the
desired depth. Depth may be guided by the 2.5 cm markings on the
catheter. The first mark begins 5 cm from the last sidehole.
9. Remove the wire guide and catheter obturator. Attach catheter to
connecting tube with stopcock, and Cook Chest Drain Valve. Attach Cook
Chest Drain Valve in direction indicated by arrow on valve. NOTE: Chest
Drain Valve may be obviated if catheter is to be connected to a water seal
suction apparatus or similar mechanical suction device. Do not connect
catheter directly to wall suction.
10. Confirm catheter placement by valve movement and fluoroscopic or
roentgenographic verification. All connections must be secure and
airtight. Perform inspections of the catheter and connections regularly.
11. Secure catheter in position at the entry site by using a bio-occlusive
dressing or suturing if desired.
12. The catheter and connected drain lines should be secured to the patient.
Excessive tension on catheter connections (e.g., in instances of patient
movement where the catheter is connected to a vacuum or drainage
collection apparatus) may cause catheter/hub separation or accidental
catheter dislodgement. To help prevent this from occurring, it is
recommended to do one or both of the following:
a. Secure the catheter hub to the patient's skin by placing tape,
suture, or a catheter securement device at the location shown in the
illustration below.
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