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4
4 APPENDIX
4-1. PENTAX Medical Compatible Reprocessing Systems/Agents
The information below is based upon material compatibility and functionality studies performed
by HOYA Corporation- PENTAX Medical Division, Japan. Reference to specific brand
name products is not an endorsement of their efcacy. Tests have shown these solutions to be
compatible with materials used in the construction of PENTAX Medical endoscopes, provided
that the manufacturers’ instructions for use are followed. This document has been prepared by
PENTAX Medical Company for PENTAX Medical customers in the United States, Canada and
Latin America.
Important
PENTAX Medical instructions for use contain detailed recommendations for the manual
reprocessing of PENTAX Medical endoscopes using PENTAX Medical supplied cleaning
accessories. Automated Endoscope Reprocessor (AER) product claims are the responsibility
of the AER manufacturer, including but not limited to cleaning, disinfection, sterilization,
rinsing, drying, biocompatibility, reprocessing instructions, required channel adapters, efcacy
validation studies, and compliance with regulatory requirements and/or professional guidelines.
Prior to reprocessing PENTAX Medical brand endoscopes in a specic model AER machine,
contact the AER manufacturer to conrm the following:
• The AER efficacy claims have been validated for the specific PENTAX Medical model
endoscopes in question.
• Instructions are available for the specific PENTAX Medical model endoscopes and
endoscope components in question.
Enzymatic Detergents
Product Brand Name Manufacturer
Cidezyme
®
XTRA (used exclusively in EvoTech ECR)
Advanced Sterilization Products (ASP)
Enzol
®
Endozime
®
Ruhof Corporation
Endozime
®
AW Plus
Enzy-Clean Care Fusion
MetriZyme
®
Metrex Research Corporation
Tergal 800 Custom Ultrasonics
ZymeX™ Enzymatic Cleaner Concentrate Sultan Healthcare