Codman UNI-SHUNT, Руководство пользователя

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ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
UNI-SHUNT
®
with Reservoir Kit
Description
The UNI-SHUNT with Reservoir Catheter is a
continuous length of barium-impregnated silicone
tubing with an access reservoir. This reservoir,
which is made of self-sealing silicone, can be
punctured with a 25-gauge, or smaller,
HUBER™-type needle. The catheter has x-ray
detectable markings on the ventricular and
peritoneal ends. The pressure is regulated by
a standard distal slit valve. The UNI-SHUNT with
Reservoir comes in five lengths; two sizes: adult
and pediatric; and three pressures: low, medium
and high (see Table 1), with the pressure regulated
by the resistance to flow through a standard distal
slit valve.
Each UNI-SHUNT with Reservoir Kit is supplied
double-wrapped sterile with the following:
a 17 gauge blunt tip needle for flushing and
testing purposes, a malleable catheter passer,
two anchoring clips and one disposable introducer.
Table 1
Catalog No. Closing Pressure Length Size
82-8501 2–5 cm H
2
O (low) 53 cm Pediatric
82-8502 5–9 cm H
2
O (medium) 53 cm Pediatric
82-8511 2–5 cm H
2
O (low) 62 cm Pediatric
82-8512 5–9 cm H
2
O (medium) 62 cm Pediatric
82-8521 2–5 cm H
2
O (low) 78 cm Pediatric
82-8522 5–9 cm H
2
O (medium) 78 cm Pediatric
82-8531 2–5 cm H
2
O (low) 90 cm Adult
82-8532 5–9 cm H
2
O (medium) 90 cm Adult
82-8533 9–14 cm H
2
O (high) 90 cm Adult
82-8541 2–5 cm H
2
O (low) 102 cm Adult
82-8542 5–9 cm H
2
O (medium) 102 cm Adult
82-8543 9–14 cm H
2
O (high) 102 cm Adult
Markings on each valve catheter indicate
the pressure:
• one dot = Low Pressure
2–5 cm H
2
O (196–490 Pa) closing pressure
• • two dots = Medium Pressure
5–9 cm H
2
O (490–882 Pa) closing pressure
• • • three dots = High Pressure
9–14 cm H
2
O (882–1372 Pa)
closing pressure
Sodium bicarbonate is used during the
manufacture of the catheter to help prevent the
slits from “knitting” together. Some amount of
this material may be visible in the form of a white
powder on the device or within the sterile package.
It is recommended that the catheter be rinsed
in sterile water or saline prior to implantation
to dissolve the sodium bicarbonate.
• Rinse the catheter in sterile water or saline
to dissolve the sodium bicarbonate.
• Follow Steps 1–3 in the “Recommended
Preimplantation Valve Patency Test” section
of this insert to “pop” the slits open.
• Use a syringe to gently rinse the lumen
of the catheter.
Indications
The UNI-SHUNT with Reservoir Catheter is intended
for use as a one-piece ventriculo-peritoneal
shunt system for the palliative treatment of
hydrocephalus. No other use is recommended.
Contraindications
The use of this product is contraindicated in
patients with a known sensitivity to barium sulfate.
WARNINGS
As with any shunting system, complications
such as infection and ventricular and peritoneal
obstruction as well as damage to the intracranial
or intra-abdominal structures may occur in patients
in whom a UNI-SHUNT with Reservoir Catheter
has been placed.
Additional General Warnings and Cautions
are contained in the references given
under “References.”
PRECAUTIONS
Inspect the sterile package carefully. Do not use if:
• the package or seal appears damaged,
• contents appear damaged, or
• the expiry date has passed.
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