Detergents, Disinfectants, And Chemical Indicators Information - Olympus OER-Pro Operation Manual

Appendix
Detergents, Disinfectants, and Chemical indicators
information
298
Dear Olympus Customer,
Re: Detergents and Disinfectants and chemical indicators required for use
with the OER-Pro
The purpose of this letter is to list the FDA cleared high-level disinfectants
and detergents required for use with the OER-Pro Automated Endoscope
Reprocessing machine. The OER-Pro is intended for use in cleaning and
high-level disinfection of Olympus flexible endoscopes and their
accessories.
• Olympus-validated concentrated disinfectant solution
Olympus requires Acecide-C High-Level Disinfectant and Sterilant for use in
the OER-Pro for high level disinfection of Olympus endoscopes and
accessories. Acecide-C is manufactured by Best Sanitizers, Inc (154 Mullen
Drive, Walton, KY) and cleared by FDA via 510(k) K091210. Olympus has
validated Acecide-C as safe and effective for reprocessing of Olympus
endoscopes and accessories. Use of a FDA cleared high-level disinfectant
that has not been validated by Olympus may be ineffective and can damage
the OER-Pro components and the endoscopes being reprocessed.
Olympus recommends using ACECIDE test strips for determining the MRC
of Acecide-C. ACECIDE test strips are manufactured by Best Sanitizers, Inc
and were cleared by FDA via 510(k) K091210.
• Olympus-validated ready-to-use disinfectant solution (Aldahol)
Olympus requires Aldahol High-Level Disinfectant for use in the OER-Pro
for high-level disinfection of Olympus endoscopes and accessories. Aldahol
is manufactured by Healthpoint Ltd. (3909 Hulen Street, Fort Worth, TX)
and was cleared by FDA via 510(k) K041360. Olympus has validated
Aldahol as safe and effective for reprocessing of Olympus endoscopes and
accessories. Use of a FDA cleared high-level disinfectant that has not been
validated by Olympus may be ineffective and can damage the OER-Pro
components and the endoscopes being reprocessed.
Olympus recommends using 3M Comply Glutaraldehyde Monitors 3989
for determining the MRC of Aldahol. 3M Comply Glutaraldehyde
Monitors 3989 are manufactured by 3M (3M Center, St. Paul, MN) and were
cleared by FDA via 510(k) K924681.
ENDOSCOPE REPROCESSOR OER-Pro Operation Manual