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CIDEX® OPA Solution is a high level
disinfectant for reprocessing heat sensitive reusable semi-critical
medical devices, for which sterilization is not feasible, and when
used according to the Directions for Use. CIDEX OPA Solution
is intended for use in manual (bucket and tray) systems made
from polypropylene, acrylonitrile-butadiene-styrene (ABS),
polyethylene, glass-filled polypropylene and/or polycarbonate
plastics. CIDEX OPA Solution may also be used in automated
endoscope reprocessors according to the manufacturer’s
instructions and should be monitored with CIDEX OPA Solution
Test Strips. See DIRECTIONS FOR USE - Reusage for Disinfection.
The semi-critical medical devices reprocessed in CIDEX OPA
Solution must first be cleaned according to a validated cleaning
protocol or standard, such as the ASTM F 1518 “US Standard
Practice for Cleaning and Disinfection of Flexible Fiberoptic and
Video Endoscopes Used in the Examination of the Hollow Viscera.”
Indications for Use: CIDEX OPA Solution is a high level
disinfectant for reprocessing heat sensitive semi-critical medical
devices, for which sterilization is not suitable, and when used
according to the Directions for Use.
Manual Processing: High Level Disinfectant at a minimum
of 20?C (68?F). CIDEX OPA Solution is a high level
disinfectant when used or reused, according to the
Directions for Use, at or above its Minimum Effective
Concentration (MEC) as determined by CIDEX OPA Solution
Test Strips, with an immersion time of at least 12 minutes for
a reuse period not to exceed 14 days.
Automatic Endoscope Reprocessors that can be set to
a minimum of 25?C: High Level Disinfectant at a minimum
of 25?C (77?F). CIDEX OPA Solution is a high level
disinfectant when used or reused in a legally marketed
automatic endoscope reprocessor (that can be set to a
minimum of 25?C) according to the Directions for Use, at or
above its Minimum Effective Concentration (MEC) as
determined by CIDEX OPA Solution Test Strips, with an
immersion time of at least 5 minutes for a reuse period not
to exceed 14 days.
Note: If your AER cannot be set to a minimum of 25?C
please follow the time and temperature stated in Indications
for Use, Manual Processing.
Minimum Effective Concentration (MEC): 0.3%.
Microbicidal Activity: The following table indicates the
spectrum of activity as demonstrated by testing of CIDEX
OPA Solution using prescribed test methods.
MICROORGANISM
VEGETATIVE ORGANISMS
Staphylococcus aureus
Salmonella choleraesuis
Pseudomonas aeruginosa
Mycobacterium bovis
FUNGI
Trichophyton mentagrophytes
VIRUSES
NON-ENVELOPED
Poliovirus Type 1
Rhinovirus Type 42
Adenovirus Type 2
Vaccinia (Wyeth)
Coxsackievirus Type B-3
ENVELOPED
Coronavirus
Cytomegalovirus
Influenza Virus [Hong Kong]
HIV-1
Herpes simplex Types 1,2
To qualify CIDEX OPA Solution as a high level disinfectant,
the reused solution passed the AOAC Sporicidal Activity
Test in 32 hours at 20?C and in 32 hours at 25?C.
Material Compatibility: CIDEX OPA Solution has been tested
and found to be compatible with the materials shown below.
METALS1 PLASTICS5
Aluminum Polymethylmethacrylate (Acrylic)
Anodized aluminum2 Nylon
Brass Polyethylene terephthalate
Carbon steel (Polyester)
Chrome plated brass2 Polystyrene
Chrome plated steel2 Polyvinylchloride (PVC)6
Copper Acrylonitrile/butadiene/styrene (ABS)
Nickel plated brass2 Polysulfone
Nickel silver alloy2 Polycarbonate7
Stainless steel3 Polyethylene
Titanium Polypropylene
Tungsten carbide2 Acetal
Vanadium steel4 PTFE
Polyamide