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General
1
1-1-2. Important Instructions
WARNING
• Reusable Medical Devices that are initially supplied non-sterile require
the end user to disinfect or sterilize them prior to initial use and to
subsequently reprocess them after each subsequent use.
• Proper care of the device after each procedure is extremely important.
Immediately (within one hour) after the completion of a procedure,
the endoscope and its removable components, and accessories should
be both pre-cleaned and mechanically cleaned with detergent solution.
Generally, if these endoscopes and accessories are not precleaned
within 15 minutes and mechanically cleaned within one hour after the
conclusion of the procedure, dried blood, mucus, or other patient debris
may cause damage to the devices or interfere with the ability of the user
to properly reprocess them.
• The use of detergent immediately after each procedure to dissolve and
remove organic contaminants and proteinaceous debris is essential to
the proper care and maintenance of the endoscope. Prior to disinfection
or sterilization, all instruments and components must be meticulously
cleaned. Failure to do so can result in incomplete or ineffective
disinfection or sterilization.
• Always inspect reprocessed endoscopes and accessories prior to use
according to their respective Instructions for Use (IFU).
• During the reprocessing process, always wear protective equipment
(e.g., gloves, gowns, face masks, etc.) to minimize the risk of cross
contamination.
• Contact the manufacturer and follow local regulations regarding safe use,
appropriate handling, and disposal of cleaning and disinfection solutions,
including alcohol and rinse water. Material Safety Data Sheets available
from the cleaning and disinfection solution manufacturer should be
consulted to provide guidance to end users about formulation, hazards,
chemical and physical properties, first aid, handling and storage,
stability, precautions, disposal, etc..
WARNING
Endoscopes are semicritical devices that require cleaning and at least high-
level disinfection. Use only legally marketed solutions and/or automated
endoscope reprocessors (AERs) for which validation testing with PENTAX
products has been performed by their manufacturers. A list of legally
marketed solutions/systems that have been determined to be compatible with
PENTAX brand products is contained in this manual.