Indications For Use; Device Description - Organ recovery systems LifePort LKT201 Gebrauchsanweisung

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 Perfusion Circuit is used to contain the kidney and perfusate under aseptic
conditions during transport.
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 as described in the LifePort Kidney Transporter Operator's Manual. Prepare
KPS-1 , Kidney Perfusion Solution in accordance to the Instructions for Use. Maintain perfusate at appropriate
®
temperature, approximately 2-8°C.
CAUTION: Where noted, perform the following procedure on an aseptic field using aseptic technique.
1. Using standard aseptic technique, prepare a sterile field on a work table and introduce all necessary
materials.
Using standard aseptic technique, remove Outer Perfusion Circuit Lid and Inner Perfusion Circuit Lid
2.
and place onto the sterile field.
Using standard aseptic technique, remove the Kidney Cradle and set aside within the sterile field.
3.
Using standard aseptic technique, fill LifePort Kidney Transporter Disposable Perfusion Circuit with 1
4.
Liter chilled (2-8°C) perfusate.
Using standard aseptic technique, replace and secure Inner Perfusion Circuit Lid followed by the Outer
5.
Perfusion Circuit Lid.
CAUTION: LifePort Kidney Transporter Disposable Perfusion Circuit inner surfaces are considered sterile,
while outer surfaces are not considered sterile.
6. Place LifePort Kidney Transporter Disposable Perfusion Circuit into LifePort Kidney Transporter.
7. Position the Tubeframe upright, perpendicular to the Pump Deck. Insert the hinges into the receivers
before rotating flat onto the Pump Deck.
8. Open the Pumphead Raceway and stretch the Pump Tubing Loop around the Infusion Pump. Close
and latch the Pumphead Raceway.
9. Rotate the Pump Deck Locking Arm 90 degrees until it clicks into place.
10. Connect the Pressure Sensor Cable from the Pump Deck to the Pressure Sensor Connector on the
Tubeframe.
NOTE: Follow the procedure outlined in the LifePort Kidney Transporter Disposable Sterile Drape
Instructions for Use to maintain aseptic conditions.
NOTE: Follow the procedure outlined in the LifePort Kidney Transporter Disposable Cannula Instructions for
Use to cannulate and secure the kidney.
Using standard aseptic technique, transfer the cannulated kidney in the Kidney Cradle to LifePort
11.
Kidney Transporter, being careful to avoid catching the Infuse Line.
NOTE: Follow the procedure in the LifePort Kidney Transporter Operator's Manual to start the perfusion
process and check for leaks.
Using standard aseptic technique, replace and secure Inner Perfusion Circuit Lid.
12.
NOTE: Follow the procedure in the LifePort Kidney Transporter Disposable Sterile Drape Instructions for Use
for removal from LifePort Kidney Transporter.
13. Replace and secure Outer Perfusion Circuit Lid.
NOTE: Follow the procedure in the LifePort Kidney Transporter Operator's Manual to continue the
perfusion process.
Instructions for Use
en