Servicing - Pentax EB-1970TK Instructions For Use Manual

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SERVICING

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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.
• A list of "compatible" reprocessing agents with PENTAX endoscopes
based upon material compatibility and functionality studies performed
by PENTAX, Japan is contained in this manual. These tests 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.
• Plese note that PENTAX does not evaluate non-PENTAX parts,
components, materials, and/or servicing methods. Therefore, questions
regarding material compatibility and/or functionality of PENTAX
instruments repaired 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.
• Independent Service Organizations should confirm the ability of these
serviced/remanufactured devices to be reprocessed safely and effectively
with reprocessing agents/systems recognized as compatible by PENTAX
for standard PENTAX products. These companies and/or remanufacturers
should be consulted to confirm whether they have performed
reprocessing validation studies on instrument models which they have
serviced (or remanufactured) that support their cleaning, high-level
disinfection, and/or sterilization via the 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 will render an
instrument equivalent to the expectations and quality of a finished device
supplied by the endoscope OEM.
Never drop this equipment or subject it to severe impact, as it can
compromise the functionality and/or safety of the unit. Should this equipment
be mishandled or dropped, do not use it. Return it to an authorized PENTAX
service facility for inspection or repair.
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