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ENGLISH
INTENDED USE
This device is used to mechanically crush stones in the biliary
duct when other methods of endoscopic removal have failed.
This device is indicated for adult use only.
NOTES
Do not use this device for any purpose other than the stated
intended use.
Store in a dry location, away from temperature extremes.
Handle and cable are sold separately.
SLH is compatible with the following lithotripsy cables: SLC,
and TTCL.
Use of this device is restricted to a trained healthcare
professional.
CONTRAINDICATIONS
Those specific to ERCP and mechanical lithotripsy.
Those associated with biliary stone extraction include, but are
not limited to: an ampullary opening inadequate to allow for
the unimpeded passage of the stone and basket.
POTENTIAL COMPLICATIONS
Those associated with ERCP include, but are not limited to:
pancreatitis, cholangitis, sepsis, perforation, hemorrhage,
aspiration, fever, infection, hypotension, allergic reaction
to contrast or medication, respiratory depression or arrest,
cardiac arrhythmia or arrest.
Those associated with basket extraction include, but are not
limited to: impaction of the object, localized inflammation,
pressure necrosis.
PRECAUTIONS
Wire cutters must be available when using this device.
Assessment of the stone size and ampullary orifice must be
made to determine necessity of sphincterotomy prior to
this procedure. The length of the intramural segment must
be evaluated before determining advisability of mechanical
lithotripsy. In the event a sphincterotomy is required,
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all appropriate cautions, warnings and contraindications must
be observed.
Reusability of the device depends in large part on care of the
device by the user. Factors involved in prolonging the life of
this device include, but are not limited to: thorough cleaning
following the instructions included in this booklet.
WARNINGS
This device is supplied non-sterile and reusable if its integrity
remains intact.
If the package is opened or damaged when received, do not
use. Visually inspect with particular attention to kinks, bends
and breaks. If an abnormality is detected that would prohibit
proper working condition, do not use. Please notify Cook for
return authorization.
Due to mechanical pressure generated with this device, basket
fragmentation in the common bile duct is a possibility that
may require surgical intervention.
Device is only recommended for use with the Cook Lithotripsy
Extraction Baskets.
Due to the varying compositions of biliary stones, stone
fracture may not be possible. If the stone cannot be fractured,
continued rotation of the handle may cause the basket wire to
break, requiring surgical intervention.
Device contains nickel which may cause an allergic reaction
and other potential systemic complications related to nickel
allergy.
SYSTEM PREPARATION
1. Examine the Luer lock fittings on the cable and the handle
for a proper fit.
2. Ratchet on the handle must be attached securely to allow
rotation in one direction.
INSTRUCTIONS FOR USE
IF USING SLC CABLE
1. Insert the basket wire and the sheath through the male
luer lock fitting on the lithotripsy handle, then through the
hole in the rotating rod of the handle. Warning: Do not
remove the sheath from the basket wire. Doing so may
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