Contraindications - COOK Medical Ultrathane Gebrauchsanweisung

ENGLISH
ULTRATHANE® SUPRAPUBIC SET WITH MAC-LOC®
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or a properly licensed
practitioner).
DEVICE DESCRIPTION
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Ultrathane® suprapubic catheter with Mac-Loc® locking loop mechanism
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Cannula assembly with round-tip obturator
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Needle obturator with trocar tip
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Clear polyvinylchloride connecting tube with one-way stopcock and drainage bag connector
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Disposable scalpel
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StatLock® catheter securing device
INTENDED USE
The Ultrathane® Suprapubic Set is used to provide bladder drainage by percutaneous placement of a loop catheter.

CONTRAINDICATIONS

None known
WARNINGS
None known
PRECAUTIONS
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Periodic evaluation is advised; the catheter must not remain indwelling more than four weeks.
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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.
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To avoid damage to the monofilament, care is necessary when placing the cannula assembly into the catheter.
INSTRUCTIONS FOR USE
1. Anesthetize the skin overlying the puncture site.
2. While gently straightening the retention loop, carefully advance the cannula assembly and round-tip obturator
into the catheter until the loop is fully straightened. Secure the cannula assembly with the Luer lock.
3. Pull the monofilament taut.
4. Remove the round-tip obturator and discard.
5. Insert the needle obturator and secure with the Luer lock.
6. Fill the bladder with sterile saline, if not already distended by urine.
7. Make a 2 mm incision in the skin approximately 2.5 to 5.0 cm above the symphysis pubis (below the palpable
bladder dome).
8. Insert the catheter vertically into the bladder on patients without previous pelvic surgery, or at a 30° angle toward
the symphysis pubis on patients with previous pelvic surgery.
9. Remove the needle obturator and observe for urine flow. If bladder pressure is low and urine fails to flow
spontaneously through the needle, aspirate urine to ascertain that the catheter tip is in the bladder. Advance the
catheter no more than 4 to 5 cm beyond the first sign of bladder fluid.
10. Once the catheter position has been confirmed, carefully remove the cannula assembly while gently advancing
the catheter several more centimeters. The catheter must be well within the bladder to ensure proper formation
of the retention loop.
11. Lock the retention loop in place. NOTE: See Mac-Loc® locking loop mechanism instructions at the end of these
instructions.
12. Attach the supplied connecting tube to the catheter and a drainage bag, and allow the bladder to empty.
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