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1-2-5. Optional Sterilization
WARNING
• Please note that PENTAX Medical has not validated any sterilization
methods for exible endoscopes othet than STERRAD
®
NX™ system.
• During the reprocessing process, always wear protective equipment
(e.g., gloves, gowns, face masks, etc.) to minimize the risk of cross
contamination.
• Sterilization efcacy and material compatibility depend on the following
factors:
- thorough cleaning of the device
- load of the devices to be sterilized
- wrapping of the devices to be sterilized
- sterilizer cycle parameters
- quality of rinse water
• Prior to sterilization, clean and dry the endoscope thoroughly. Failure to
do so can result in ineffective or incomplete sterilization.
• Use a chemical indicator (CI) and/or biological indicator (BI) to control
the sterilization process and ensure sterilization efcacy.
• The manufacturer of the sterilizer should be consulted to confirm that
test data exists to substantiate that no harmful levels of any residues
(active/inert ingredients, their by-products or derivatives of the
processed devices) remain on any instrument that may pose a risk to
patients and users.
• After sterilization, ensure that the package is intact. If there are any
signs of abnormalities such as stains, tears, or any other indications that
the packaging has been damaged or opened, repeat the sterilization
process with new packaging.
CAUTION
• Due to the heat sensitive nature and/or the specific biocompatible
materials used in the construction of flexible endoscopes, some
sterilization systems/processes/solutions may have detrimental effects
on flexible endoscopes. To avoid the potential for instrument damage
and/or endoscope failure, confirm the compatibility of such systems/
solutions with your local PENTAX dealer prior to use with any PENTAX
products. Also, confirm the specific claim(s) of any sterilization
methods/processes with the sterilizer manufacturer to ensure that they
have performed microbiological validation studies to support their claims
of achieving sterilization of device specic exible endoscope models and
endoscope components.
• NEVER place the endoscope in a steam sterilizer!
Endoscope
Sterilization
1