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