Pentax EC-380LKp, Руководство пользователя

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5-1. SERVICING
Prior to returning any instrument for repair to PENTAX, the instrument should first undergo appropriate reproc-
essing/decontamination procedures for the purpose of infection control. Check with your local PENTAX service
facility for more details.
1) All instruments requiring repair should be shipped in the original carrying case with appropriate packing
along with comments describing the instrument damage and complaint.
2) A repair purchase order number, contact name and phone number of the individual responsible for authoriz-
ing repairs, as well as shipping address should be included.
3) The “Red” ETO gas sterilization venting cap should be attached to the instrument if it will be shipped by air
freight.
4) Any accessories and/or scope component potentially related to the scope damage or complaint should also be
returned with the endoscope.
5) Soaking caps should also be returned with the scope to check/confirm the integrity of their watertight seal.
6) After servicing, all endoscopes must be reprocessed prior to patient use.
7) For disposal of instruments, follow local or country regulations.
WARNING:
Your local PENTAX distributor 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 propri-
etary 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 remanufac-
turer. 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 unau-
thorized 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 reproc-
essed 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 con-
sulted 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 steriliza-
tion of these endoscopes via the normal scope 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 scope OEM.