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Tristel Duo ULT is a high level disinfect foam for reprocessing ultrasound probes. It can be used to high level disinfect endocavity transvaginal and transrectal probes, and skin surface transducers that may contact non-intact skin during use. Tristel Duo ULT is a high level disinfectant when used in accordance with the directions for use, including a disinfection contact time of 2 minutes, at room temperature and a concentration at or above Minimum Recommended Concentration (MRC). Tristel Duo ULT must be applied on the surface of an ultrasound probe using Duo Wipes. Duo Wipes are intended to apply Tristel Duo ULT foam on the surface of ultrasound probes and to remove residue of the foam after high level disinfection. Each dose of Tristel Duo ULT foam and each Duo Wipe are single use. The semi-critical ultrasound probes reprocessed by Tristel Duo ULT must first be cleaned according to a validated cleaning protocol or standard and following the device manufacturers' instructions. Tristel Duo ULT foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC. MRC: ~90% v/v (~280ppm) at point of use. MRC of Tristel Duo ULT may be verified using Duo Test Strips. Tristel Duo ULT is intended to be marketed for prescription use.

Tristel Duo ULT is a high level disinfectant foam intended to disinfect cleaned, reusable, nonlumened ultrasound probes. Tristel Duo ULT is intended to be used by qualified healthcare personnel. Tristel Duo ULT does not sterilize. Tristel Duo ULT generates chlorine dioxide foam from two "precursor" solutions (Base Solution and Activator Solution), which are packaged separately within two individual containers and secured together within a single dispenser apparatus known as the "pump" shown in Figure 2. When depressed, the pump dispenses these solutions at equal volumes. The components of the Base and Activator solutions chemically react. This reaction generates chlorine dioxide in liquid solution, which is the active germicidal ingredient. A mesher present in the applicator pump causes the formulation to be dispensed as a ready-to-use foam. The active ingredient in Tristel Duo ULT high level disinfectant is chlorine dioxide, which is generated in situ from the Activator and Base solutions. Tristel Duo ULT also contains other (D) CI (b) 49 ingredients, such as sodium chlorite, citric acid monohydrate. (0) 49) The Duo bottle configuration consists of the two bottles (containers), a single pump head with two thread neck closures and a cap. Each Duo bottle contains 125 milliliters (mL)/4.40 fl oz of Base Solution and 125 mL/4.40 fl oz of Activator Solution. The left and right containers are made to the same specification, with the difference in the orientation of the neck thread. The bottle is handheld. Shown in Figures 3 and 4. An 80% V/V dilution of Duo was determined as the Minimum Effective Concentration (MEC) for Duo. Duo Wipes are dry, non-woven, low-linting wipes. They are specifically designed to apply the Tristel Duo ULT foam onto the surface of a medical device. A user lays the Duo Wipe in one hand and applies 4 doses of the Tristel Duo ULT foam before closing their hand around the wipe and waiting for 10 seconds. The wipe can then be used to spread the foam in a massaging motion from one end of the device to the other 4 times. After the device is wiped, it is left undisturbed for 2 minutes. The Duo Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of the Tristel Duo ULT high level disinfectant foam is above or below the minimum recommended concentration (MRC) (~90% v/v /~280 ppm). Tristel Duo ULT foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC. The Duo Test Strips, when used in accordance with directions for use detect the MRC and above giving a color indication of a "PASS" and if the concentration is below the MRC a color indication of a "FAIL".