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 efficacy. 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, efficacy
validation studies, and compliance with regulatory requirements and/or professional guidelines.
Prior to reprocessing PENTAX Medical brand endoscopes in a specific model AER machine,
contact the AER manufacturer to confirm 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)
4 Enzol®
Advanced Sterilization Products (ASP)

Endozime®
Ruhof Corporation
Endozime® AW Plus

Enzy-Clean Care Fusion

MetriZyme® Metrex Research Corporation

Tergal 800 Custom Ultrasonics

ZymeX™ Enzymatic Cleaner Concentrate Sultan Healthcare

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High Level Disinfectants

The following liquid chemical germicides have received FDA 510(k) clearance for claims of
high level disinfection (HLD). Some HLD products may have multiple label claims and/or may
be FDA-cleared only for use in a legally marketed AER machine that can attain specific use
parameters (e.g., temperature).

Product Brand Name Manufacturer

Cidex® OPA
Cidex® OPA-C (used exclusively in EvoTech ECR)
Advanced Sterilization Products
Cidex® Activated Dialdehyde Solution(14-Day
Glutaraldehyde)

MetriCide® (Glutaraldehyde - may also be marketed

Metrex Research Corporation
as Omnicide NS or MaxiCide® NS)

Sporicidin® (Glutaraldehyde) Contec Incorporated

Rapicide® (Glutaraldehyde) Medivators Inc.

Wavicide®-01 (Glutaraldehyde) Medical Chemical Corporation

Sterilization Agents/Processes

The following agents/processes have received FDA 510(k) clearance for claims of sterilization:

Ethylene Oxide / Carbon Dioxide (80:20 gas mixture)

Ethylene Oxide / Carbon Dioxide (90:10 gas mixture)

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