Warnings And Cautions; Explanation Of Symbols - Organ recovery systems LifePort Instrucciones De Uso

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), +55 11 9 8638 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 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 Life-
Port 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.

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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