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4. CARE AFTER USE
IMPORTANT INSTRUCTIONS
Cleaning-Disinfection-Sterilization: PENTAX Endoscopes
To maintain maximum performance and a long service life of the endoscope, proper care after each proce-
dure is extremely important. Immediately after the completion of a procedure, the endoscope and its com-
ponents should be thoroughly and carefully cleaned. If the endoscope or its components are left uncleaned
for some time after use, dried blood, mucous, contrast material or other patient debris may cause damage
to the instrument (component) or may interfere with the ability of the user to properly reprocess the endo-
scope or component
NOTE:
This manual has been written having regard to ISO 17664 and national guidelines on reprocessing of medical
products (e.g. RKI, DGS/DHOS).
NOTE:
This owner’s manual contains detailed recommendations on the
manual reprocessing
of PENTAX
endoscopes using PENTAX supplied cleaning/disinfecting adapters. Automated endoscope reproces-
sors (AER) may provide a means of reprocessing flexible endoscopes, including PENTAX instruments.
Only those Automated Endoscope Reprocessors (AERs) should be used whose manufacturers provide
device-specific instructions and have validation data that support each AER claim with respect to PEN-
TAX model instruments.
AER manufacturers should be consulted for their specific claims including but not necessarily limited to
a) the ability of the AER to provide a cleaned and high-level disinfected (or sterilized) endoscope and
scope components (ex. valves),
b) the identification of any special feature area (internal channel) or scope component that can not be
reprocessed and therefore requires manual reprocessing,
c) the microbial quality of the rinse water,
d) the inclusion of an “automated” alcohol rinse cycle.
e) the inclusion of a terminal drying cycle that removes the majority of water/fluid within scope channels,
f) maintenance procedures for water filter replacement and/or decontamination of the filtration system to
ensure the microbial claim of water, etc.
g) compliance with local regulations and/or guidelines
Summary of PENTAX Reprocessing Instructions
PENTAX reprocessing instructions can be broken down into seven basic steps.
1) Internal Channels
Section 4-1-1
2) Pre-Cleaning (in the Examination Room)
Section 4-1-2
3) Leakage Testing (in a designated Decontamination Area)
Section 4-1-3
4) Cleaning (in a designated Decontamination Area)
Section 4-1-4
5) High-Level Disinfection or sterilization (in a designated Decontamination Area) Section 4-1-5, 4-1-6
6) Endoscopic Accessory Instruments (EAIs) and Endoscope Components
Section 4-2
7) Post Reprocessing
Section 5
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