Warnings And Cautions; Explanation Of Symbols - Organ recovery systems LifePort LKT201X Manual Del Usuario

22.
Using standard aseptic technique, remove Inner Perfusion Circuit Lid.
23.
Using standard aseptic technique, transfer the cannulated kidney in the Kidney Cradle to LifePort Kidney Transporter,
being careful to avoid catching the Infuse Line.
NOTE: Refer to LifePort Kidney Transporter Operator's Manual to start the perfusion process and check for leaks.
24.
Using standard aseptic technique, replace and secure Inner Perfusion Circuit Lid.
NOTE: Follow the procedure outlined in the LifePort Kidney Transporter Disposable Sterile Drape IFU for removal from
LifePort Kidney Transporter.
25.
Replace and secure Outer Perfusion Circuit Lid.
NOTE: Follow the procedure in LifePort Kidney Transporter Operator's Manual to continue the perfusion process.
Storage Conditions: Store between 2ºC and 30ºC. Avoid excessive heat and humidity. Keep dry and keep away from direct
sunlight. Sterile unless package is damaged or open.
Technical Assistance: Please contact Organ Recovery Systems 24/7 Perfusion Helpline at +1.866.682.4800 (toll free in
US), +32.2.715.0005 (Belgium), +55.11.98638.0086 (Brazil), +33.967.23.00.16 (France), or +34.910.91.16.16 (Spain).
Contraindications: There are no known contraindications when used as directed.

WARNINGS AND CAUTIONS

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Only
CAUTION: LifePort Kidney Transporter Disposable Products should be stored indoors in a dry location out of direct sunlight.
WARNING: Visually check LifePort Kidney Transporter Disposable Products. Do not use if parts are cracked or broken.
WARNING: For single use only. Do not reuse, reprocess or resterilize. Reusing, reprocessing, or resterilization of single-use
devices creates a potential risk of patient or user infections due to contamination. This contamination may lead to injury, illness,
or other serious patient complications.
WARNING: Use standard aseptic technique and universal precautions (e.g., gloves, masks, gowns, goggles or equivalent
eye protection, biohazard bags) when handling the kidney, and when handling and disposing of LifePort Kidney Transporter
Disposable Products and perfusate to prevent the possible transmission of pathogens to medical personnel and patients. The
single practitioner, working alone must pay special attention to maintain these conditions.
WARNING: Before the operator begins to apply the LifePort Kidney Transporter Disposable Sterile Drape, the Outer Perfusion
Circuit Lid should be removed. The exterior surfaces of the Outer Perfusion Circuit Lid are not considered part of a sterile field.
Use standard aseptic technique when handling the interior surface.
WARNING: Oxygen must be handled in accordance with institutional safety procedures.
WARNING: Only experienced and properly instructed persons should handle oxygen.
WARNING: A fire may occur if oxygen comes in contact with a spark or other material that burns easily.
WARNING: Do not use electrical equipment that can produce a spark as it may ignite and burn when oxygen is in use.
WARNING: Do not smoke, light matches or use a lighter in a room where oxygen is being used.
WARNING: Do not use petroleum-based products.
WARNING: Use only oxygen approved lubricants and oxygen approved sealings.
WARNING: Room should be labeled with "Oxygen in Use" sign.

EXPLANATION OF SYMBOLS

Warning/Caution
Lot Number
Reference Number
REF REF
Do Not Reuse
Sterile Medical Devices
STERILE EO STERILE EO
Using Ethylene Oxide
Medical Device
Use By, YYYY-MM-DD
Date of Manufacture, YYYY-MM-DD
Manufacturer
2
Do Not Resterilize
STERILIZE STERILIZE
Oxidizing Material
Instructions for Use
Temperature Limits
Consult Instruction for Use
Keep Away From Sunlight
Keep Dry
Prescription Medical Device
Only
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