4
result in basket fragmentation and consequently require
surgical intervention.
2. Wrap the wire and the sheath several times around the rod
to secure them to the rod. (See fig. 1)
IF USING TTCL CABLE
1. Insert the basket wires through the male luer lock fitting
on the lithotripsy handle, then through the hole in the
rotating rod of the handle.
2. Wrap the basket wires several times around the rod to
secure them to the rod. (See fig. 1)
STONE FRACTURE
1. To fracture the stone, apply pressure by slowly rotating the
handle.
Note:
Slow, constant pressure is often the most
effective method of fracturing a stone. A sudden release
of pressure may indicate fracture of the stone, fracture of
the basket, or loss of the stone from the basket.
Note:
The
handle will only move in one direction unless the ratchet
is released.
2. After the stone has been fractured, assess the need to
remove the fractured stone from the duct.
3. Release the ratchet on the handle of the lithotriptor to
remove the basket.
DEVICE CLEANING AND DISPOSAL
1. Upon completion of the procedure, clean and prepare the
handle for future use following the cleaning instructions
that follow. During cleaning, inspect the integrity and
the function of the device to determine advisability of
reuse. If kinks, bends or breaks exist, do not use. Dispose
of the device per institutional guidelines for biohazardous
medical waste.
CLEANING INSTRUCTIONS
EQUIPMENT / SUPPLIES
• Disposable lint-free cloth
• Soft-bristled brush
• Cold tap water
• pH neutral detergent (i.e. Steris Prolystica etc.)
CLEANING
1. Immediately after use, submerge the handle in a cleaning
solution using pH neutral detergent and cold tap water.
Soak the handle for twenty (20) minutes.
2. Wipe the handle using a clean, lint free cloth soaked in
cleaning solution for thirty (30) seconds.
3. Gently brush the handle with a soft nylon bristle brush for
one (1) minute to remove all foreign matter.
4. Rinse the handle thoroughly using cold running water for
one (1) minute.
5. Ultrasonically clean the handle using a cleaning solution of
pH neutral detergent and cold tap water prepared in the
Ultrasonic Cleaner for a minimum of 15 minutes per the
ultrasonic cleaner manufacturer’s instructions.
6. Remove the handle from the ultrasonic cleaner, then rinse
thoroughly with cold tap water for one (1) minute.
7. Gently wipe the handle dry with a lint-free cloth.
8. Package the handle for storage.
Note:
Prior to packaging
the handles for storage, follow the inspection steps listed
below to determine advisability of reuse.
INSPECTIONS
Upon cleaning, inspect integrity and function of the device. If
bends or breaks exist, do not use.
Examine the Luer lock fittings on handle for a proper fit.
Ratchet on the handle must be attached securely to allow
rotation in one direction.
SERIOUS INCIDENT REPORTING
Per European Regulations: Report any serious incident that
has occurred in relation to this device to the manufacturer and
the competent authority of the EU Member State where the
device was used.
БЪЛГАРСКИ
ПРЕДНАЗНАЧЕНИЕ
Това изделие се използва за механично разбиване на
камъни в жлъчните пътища, когато други методи за
ендоскопска екстракция са неуспешни.
Това изделие е показано за употреба само при възрастни.
ЗАБЕЛЕЖКИ
Не използвайте това изделие за друга цел, освен
посоченото предназначение.
Да се съхранява на сухо място, далеч от екстремни
температури.
Дръжката и кабелът се продават отделно.
SLH е съвместима със следните кабели за литотрипсия: SLC
и TTCL.
Това изделие може да се използва само от обучен
медицински специалист.
ПРОТИВОПОКАЗАНИЯ
Специфични противопоказания за ендоскопска
ретроградна холангиопанкреатография (ЕРХП) и
механична литотрипсия.
Противопоказанията, свързани с екстракцията на жлъчни
камъни включват, но не са ограничени до: недостатъчен
ампуларен отвор за безпрепятствено преминаване на
камъка и кошничката.
ПОТЕНЦИАЛНИ УСЛОЖНЕНИЯ
Усложненията, свързани с ЕРХП, включват, но не са
ограничени до: панкреатит, холангит, сепсис, перфорация,
кръвоизлив, аспирация, повишена температура, инфекция,
