COOK Medical Tenckhoff Instrucciones De Uso página 4

4. Fill a 20 ml syringe with sterile saline and attach it to the access needle.
Advance the needle through the incision until resistance is encountered.
NOTE: At this point, the needle tip should be less than 1 cm from
entering the peritoneal cavity.
5. Instruct the patient to tense his or her abdominal muscles, then advance
the needle tip into the peritoneal cavity while simultaneously depressing
the plunger on the syringe. NOTE: Depressing the plunger on the syringe
while advancing the needle should result in a jet of saline forcefully
exiting the needle tip; this will make damage to any intraperitoneal soft
tissues less likely.
6. Leaving the needle in place, remove the syringe and advance the wire
guide through the needle and into the peritoneal cavity.
7. Remove the needle.
8. Introduce the Peel-Away® sheath-introducer assembly over the wire guide
well into the peritoneal cavity.
9. Remove the wire guide and introducer, leaving the Peel-Away sheath in
place.
10. Fill or at least flush the peritoneal dialysis catheter with a heparin solution.
This will reduce the likelihood of fibrin formation in the catheter during
the insertion procedure.
11. Insert the catheter through the sheath and into the peritoneal cavity,
then peel away the sheath. Position the distal catheter cuff just above the
linea alba (for a median insertion) or just above the rectus abdominus
muscle (for a paramedian insertion). NOTE: Some blunt dissection may be
necessary to create a space for the cuff.
12. Select an appropriate catheter exit site above or below, but not at, the
belt line. The proximal catheter cuff should be positioned 1-2 cm from the
point of exit through the skin, without dislodging the distal cuff.
13. After infiltrating sufficient local anesthetic, introduce a tunneling tool
through the initial skin incision. Tunnel subcutaneously out to the
selected site and puncture through the skin to create an exit.
14. Pressfit the peritoneal dialysis catheter to the other end of the tunneling
tool; pull the catheter through the tunnel and out through the exit site.
Some blunt dissection may again be necessary to create space for the
proximal cuff. Note that the tunneling tool has been designed to produce
a snug fit of the skin around the exit site so as to decrease the risk of
leakage and exit site infection.
15. If necessary, one or two resorbable subcutaneous sutures may be placed
before closing the initial surgical skin incision.
16. Test the catheter for inflow and outflow dynamics.
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended
for one-time use. Sterile if package is unopened or undamaged. Do not use
the product if there is doubt as to whether the product is sterile. Store in a
dark, dry, cool place. Avoid extended exposure to light. Upon removal from
packages, inspect the product to ensure no damage has occurred.
REFERENCES
These instructions for use are based on experience from physicians and (or)
their published literature. Refer to your local Cook sales representative for
information on available literature.
DANSK
TENCKHOFF KATETRE OG SÆT TIL KRONISK
PERITONEALDIALYSE
FORSIGTIG: I henhold til amerikansk lovgivning må dette produkt kun
sælges til en læge (eller en autoriseret behandler) eller efter dennes
anvisning.
BESKRIVELSE AF PRODUKTET
Tenckhoff kronisk peritonealdialysekateter er silikonekatetre med sideporte
og dobbelte retentionsmanchetter, som fås i en række længder og French-
størrelser, og i konfigurationer enten med en lige eller en spiralspids. Sættene
indeholder også en indføringskanyle i passende størrelse, en kateterleder og
tilbehør til brug ved anlæggelse af katetret.
TILSIGTET ANVENDELSE
Tenckhoff kronisk peritonealdialysekateter er beregnet til kronisk adgang til
peritonealkaviteten.
INFORMATION OM MR-SCANNING
Ikke-klinisk afprøvning har vist, at Tenckhoff kronisk peritonealdialysekateter
er MR Conditional. Det kan scannes sikkert efter anlæggelse under følgende
betingelser:
• Statisk magnetfelt på 3,0 tesla eller mindre
• Maksimal rumlig magnetfeltstyrke for gradient på højst 1600 gauss/cm
• Normal driftstilstand: Maksimal gennemsnitlig absorptionsrate (SAR)
for hele kroppen på 2,0 W/kg ved højst 15 minutters scanning (dvs. pr.
scanningssekvens)
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