Care After Use - Pentax EG-2990i Instructions For Use Manual

4. CARE AFTER USE

For the cleaning and maintenance of the equipment after its use, please refer to the
separate Instructions for Use (reprocessing).
WARNING:
Instrument repairs should only be performed by an authorized PENTAX
service facility. PENTAX assumes no liability for any patient/user injury,
instrument damage or malfunction, or REPROCESSING FAILURE due to
repairs made by unauthorized personnel.
Your local PENTAX service facility can provide a list of "compatible"
reprocessing agents with PENTAX endoscopes based upon material
compatibility and functionality studies performed by PENTAX, Japan.
These tests of course apply only to genuine PENTAX parts, components
and materials including proprietary adhesives, sealants, lubricants,
etc. specifically selected for use in PENTAX endoscopes to satisfy their
original design criteria. PENTAX manual reprocessing instructions supplied
with each product have been validated for PENTAX endoscopes utilizing
exclusive PENTAX parts/materials and assembled based upon proprietary
PENTAX manufacturing technologies and/or servicing techniques.
It must be recognized that PENTAX does not evaluate non-PENTAX
parts, components, materials and/or servicing methods and therefore
questions regarding material compatibility and/or functionality of PENTAX
instruments built with these unauthorized, untested and unapproved
items, materials, repair/assembly methods must be referred to the third
party service organization and/or device remanufacturer. It is unknown
to PENTAX if serviced or remanufactured instruments (performed by
unauthorized PENTAX entities) which still bear a PENTAX label are within
PENTAX device specifications and/or if unauthorized activities have
significantly changed the instrument's performance, intended use, safety
and/or effectiveness.
These companies should confirm the ability for these serviced/
remanufactured devices to be reprocessed safely and effectively with
reprocessing agents/systems recognized as compatible by PENTAX
for standard PENTAX products. These third party companies and/or
remanufacturers should be consulted to confirm if they have performed
reprocessing validation studies on instrument models which they
have serviced (or remanufactured) that support the cleaning, high-
level disinfection and/or sterilization of these endoscopes via the
normal endoscope OEM reprocessing recommendations, standard
AER device-specific instructions and/or their own unique reprocessing
recommendations.
Ultimately, owners of these medical devices are responsible for selecting
an appropriate service facility or vendor whose activities render an
instrument to the same expectations and quality of a finished device
supplied by the endoscope OEM.
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