Contraindications - COOK Medical WAYNE-PNEUMOTHORAX-SET Gebrauchsanweisung

ENGLISH
WAYNE PNEUMOTHORAX SET
For Trocar 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 Wayne Pneumothorax Set consists of a stainless steel needle
obturator with Peel-Away® spacer, 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 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. Preassemble catheter, 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.
2. 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.
3. 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.
4. Without removing the Peel-Away spacer, fully straighten the curved
catheter tip by advancing the needle obturator. (Fig. 1)
5. After straightening the catheter tip, remove the Peel-Away spacer
and advance the needle until the point is showing at the catheter
tip. NOTE: Care must be taken to fully straighten pigtail before
advancing needle to avoid puncturing catheter. (Fig. 2)
6. Holding the base of the needle against the palm of the hand, push
the catheter through the incision and over the rib into the pleural
cavity. Once into the pleural cavity, withdraw the inner needle stylet
slightly and advance the catheter slightly using the obturator.
7. The catheter may then be advanced over the obturator to the
desired depth. The catheter pigtail will form as advanced. Depth
may be guided by the 2.5 cm markers on the catheter. The first one
begins 2.5 cm from the last sidehole. NOTE: If there is uncertainty as
to whether the obturator and catheter tip are well within the pleural
cavity as with a small pneumothorax, the inner needle stylet may be
fully removed to determine whether there is a free flow of air.
8. Remove the obturator and confirm placement by valve movement
and fluoroscopic or roentgenographic verification. All connections
must be secure and airtight. Perform inspections of the catheter
and connections regularly.
9. Secure catheter in position at the entry site by using a bio-occlusive
dressing or suturing if desired.
10. 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:
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