COOK Medical LithAssist Instructions For Use Manual page 3

LITHASSIST®
SUCTION CONTROL FOR LASER LITHOTRIPSY
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
The LithAssist is a rigid device with a handle for control, used in conjunction with a holmium laser for lithotripsy. The
device has a dual lumen cannula. The small lumen provides access for the introduction of a laser fiber for use during
lithotripsy of kidney or bladder stones. The large lumen provides suction assistance to extract fluid, soft tissue and
stone fragments when used with an independent vacuum source. The device features a trigger mechanism that
enables the user to manually control the amount of suction.
INTENDED USE
The LithAssist is intended to provide access for laser fiber introduction and suction for fluid, soft tissue, and stone
fragment removal during laser lithotripsy.
CONTRAINDICATIONS
None known
WARNINGS
None known
PRECAUTIONS
•
This device is conductive. Avoid contact with any electrified instrument.
•
Take normal precautions when using a laser (i.e., safety glasses).
• This product is intended for use by physicians trained and experienced in urologic lithotripsy techniques. Standard
techniques for use of an endoscope and laser fiber should be employed.
• 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.
INSTRUCTIONS FOR USE
1. Attach suction tubing to the universal adapter at the bottom of the LithAssist. Adjust suction to preference.
2. Using previously established kidney/bladder access, maintain direct vision with a rigid endoscope.
3. Insert the LithAssist into the working channel of the endoscope until the distal end is visible.
4. Maintain direct visualization of the stone, and insert a laser fiber through the Tuohy Borst adapter at the rear of
the LithAssist.
5. Once the laser fiber extends beyond the distal end of the LithAssist to the desired distance, tighten the Tuohy
Borst adapter around the laser fiber to secure it in place.
6. Control suction via the handle trigger while lasing the stone. NOTE: A fully open trigger provides the highest
suction; a fully closed trigger provides no suction. The trigger may be locked into the fully closed position via the
sliding switch immediately above the handle.
NOTE: The device may become clogged with stone material when suctioning. If this occurs, remove the device
from the patient, fully depress/lock the handle to shut off the suction, and flush the obstructed lumen with a
saline-filled syringe via the Luer lock on the rear of the device.
7. Repeat steps 3 through 6 as necessary.
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
3
ENGLISH