Indications For Use; Device Description - Organ recovery systems LifePort Instrucciones De Uso

Universal
SealRing

INDICATIONS FOR USE

LifePort Kidney Transporter (LKT) system is intended to be used for the continuous hypothermic machine perfusion of
kidneys for the preservation, transportation and eventual transplantation into a recipient.

DEVICE DESCRIPTION

LifePort Kidney Transporter Disposable Universal SealRing Cannula is used when the vessel to be perfused ends
with or without an aortic patch or similar condition.
The complete LifePort Kidney Transporter system is comprised of the following components:
• LifePort Kidney Transporter (LKT100P/LKT101P)
• LifePort Kidney Transporter Disposable Perfusion Circuit (LKT201)
• LifePort Kidney Transporter Disposable Sterile Drape (LKT300)
• LifePort Kidney Transporter Disposable Cannula (CAN/UCAN)
INSTRUCTIONS FOR USE
Prepare LifePort Kidney Transporter and LifePort Kidney Transporter Perfusion Circuit as described in their Instructions
for Use. If cannulating multiple vessels, refer to LifePort Kidney Transporter Disposable Coupler Instructions for Use.
CAUTION: Where noted, perform the following procedure on an aseptic field using aseptic technique.
1. Using standard aseptic technique, introduce LifePort Kidney Transporter Disposable Universal
SealRing Cannula onto the sterile field.
2. Using standard aseptic technique, open LifePort Kidney Transporter Disposable Universal SealRing
Cannula by unhooking the straps, unsnapping and opening the right anvil.
3. Using standard aseptic technique, position the vessel in the center of the anvils so the terminated end
of the vessel is approximately 1.5–2.0mm above the top surface of the anvils.
4. Using standard aseptic technique, close the right anvil, capturing the vessel with an audible click.
NOTE: If necessary, retention stays can be added to the vessel using suture or other appropriate material.
Suture Tie Down Cleats and slots have been provided to facilitate positioning.
5. Using standard aseptic technique, lower the upper portion of LifePort Kidney Transporter Disposable
Universal SealRing Cannula while carefully bringing the conical seal into the interior of the vessel.
NOTE: Viewing through the magnified sight-glass, verify that the vessel orifice is centered, circular in shape
and not occluded.
6. Using standard aseptic technique, wrap each strap around both cannula halves and secure the straps
to their posts.
7. Using standard aseptic technique, place the kidney in the Kidney Cradle and snap LifePort Kidney
Transporter Disposable Universal SealRing Cannula into the Cannula Mount.
NOTE: If perfusing multiple vessels, only the main vessel cannula shall be connected to the Cannula Mount.
8. Using standard aseptic technique, adjust the height of the Cannula Mount and rotation of the cannula
to comfortably position the vessel.
9. Using standard aseptic technique, visually inspect the vessel, ensuring there are no twists or
occlusions.
10. Using standard aseptic technique, secure the Mesh Organ Restraint over the kidney in the Kidney
Cradle, allowing for slight swelling while being perfused.
NOTE: Follow the procedure in the LifePort Kidney Transporter Disposable Perfusion Circuit Instructions for
Use on how to place the kidney and Kidney Cradle within LifePort Kidney Transporter Disposable Perfusion
Circuit.
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Instructions for Use
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