Indications For Use; Device Description - Organ recovery systems LifePort LKT201X Manual Del Usuario

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 Oxygenation Perfusion Circuit is used to contain the kidney and perfusate under
aseptic conditions during transport, with the option to introduce oxygen into the perfusate.
The complete LifePort Kidney Transporter system is comprised of the following components:
• LifePort Kidney Transporter (LKT100P/LKT101P)
• LifePort Kidney Transporter Disposable Oxygenation Perfusion Circuit (LKT201X)
• Oxygenation Delivery Tube (900-00044)
• Oxygenation Connector (900-00045)
• LifePort Kidney Transporter Disposable Sterile Drape (LKT300CE)
• LifePort Kidney Transporter Disposable Cannula (CAN/UCAN)
INSTRUCTIONS FOR USE
Prepare LifePort Kidney Transporter as described in LifePort Kidney Transporter Operator's Manual. Prepare KPS-1
Perfusion Solution in accordance to the Instructions for Use. Maintain perfusate at proper temperature, approximately 2-8°C.
CAUTION: Where noted, perform the following procedure on an aseptic field using aseptic technique.
Using standard aseptic technique, prepare a sterile field on a work table and introduce all necessary materials.
1.
Using standard aseptic technique, remove LifePort Kidney Transporter Disposable Perfusion Circuit, Oxygenation
2.
Delivery Tube, and Oxygenation Connector from their respective packaging.
WARNING: Visually check LifePort Kidney Transporter Disposable Products before use. Do not use if parts are cracked or
broken.
Using standard aseptic technique, remove Outer Perfusion Circuit Lid and Inner Perfusion Circuit Lid and place onto
3.
the sterile field.
Using standard aseptic technique, remove the Kidney Cradle and set aside within the sterile field.
4.
CAUTION: Verify the Uptake Line is within the Low Fluid Detection Chamber inside the Organ Cassette.
Using standard aseptic technique, attach the Oxygenation Delivery Tube and Oxygenation Connector to Oxygenation
5.
Perfusion Circuit.
Using standard aseptic technique, fill Oxygenation Perfusion Circuit with 1 Liter chilled (2-8°C) perfusate.
6.
Using standard aseptic technique, replace and secure Inner Perfusion Circuit Lid followed by the Outer Perfusion
7.
Circuit Lid.
CAUTION: Oxygenation Perfusion Circuit inner surfaces are considered sterile, while outer surfaces are not considered sterile.
8. Place Oxygenation Perfusion Circuit into LifePort Kidney Transporter.
9. Position the Tubeframe upright, perpendicular to the Pump Deck. Insert the hinges into the receivers before rotating
flat onto the Pump Deck.
CAUTION: Make sure Oxygenation Delivery Tube is not pinched or below the Tubeframe and is easily accessed from the front.
10. Open the Pumphead Raceway and stretch the Pump Tubing Loop around the Infusion Pump. Close and latch the
Pumphead Raceway.
11. Rotate the Pump Deck Locking Arm 90 degrees until it clicks into place.
12. Connect the Pressure Sensor Cable from the Pump Deck to the Pressure Sensor Connector on the Tubeframe.
13. Remove and set aside the Oxygenation Connector from the Oxygenation Delivery Tube.
14. Connect oxygen supply tubing (not included) from an oxygen source with a regulator to the Oxygenation Delivery Tube.
CAUTION: Only use medical-grade oxygen that meets the regulatory requirements for compressed medical gas.
NOTE: Oxygen supply tubing is not provided by Organ Recovery Systems.
Press and hold the POWER button until you hear an audible beep, then release.
15.
16. Press the WASH button to begin WASH mode.
17. Turn on the oxygen and administer at a rate of 0.5 Liters/min for a minimum of 20 minutes.
CAUTION: During perfusate oxygenation, do not exceed an oxygen flow of 0.5 Liters/min to avoid overpressurizing the Organ
Chamber while both Lids are secured.
NOTE: Follow the procedure outlined in the LifePort Kidney Transporter Disposable Cannula Instructions for Use (IFU)
to cannulate and secure the kidney.
18. Once the kidney is ready to be placed into the Organ Chamber, turn off oxygen and disconnect the oxygen supply
tubing from the Oxygenation Delivery Tube and oxygen source.
Disconnect the Oxygenation Delivery Tube from the Oxygenation Perfusion Circuit.
19.
Fasten the Oxygenation Connector to the open Oxygen Delivery Tube on the Oxygenation Perfusion Circuit to maintain
20.
aseptic conditions.
WARNING: The Oxygenation Connector must be applied to the Oxygen Delivery Tube to prevent leakage or contamination of
the aseptic field.
Remove the Outer Perfusion Circuit Lid.
21.
NOTE: Refer to LifePort Kidney Transporter Disposable Sterile Drape IFU to maintain aseptic conditions.
Instructions for Use
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