Warnings And Cautions; Explanation Of Symbols - Organ recovery systems LifePort LKT201 Gebrauchsanweisung

Storage Conditions: Store between 2ºC and 40ºC. 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 +866.682.4800 (toll
free in US), +32.2.715.0005 (Belgium), 0800.940.0057 (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 loose,
cracked, broken, or liquid is leaking. Check that all fittings are tight before installation.
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.

EXPLANATION OF SYMBOLS

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