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The LIC Instrument Processor when used with the Manzi Detergent MD10, the Manzi Sterilant MS10 concentrate ( MEC 0.49% PAA, minimum contact temperature of 120° F for a contact time of 5 minutes), and filtered and ozonated final rinse water, is indicated for cleaning and high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the LIC Instrument Processor. The Manzi Detergent MD10 concentrate when used with the LIC Instrument Processor is indicated for the cleaning of heat sensitive semi-critical endoscopes used in health care settings by health care workers. The Manzi Sterilant MS10 concentrate when used in the LIC Instrument Processor is indicated for high level disinfection of heat sensitive semi-critical endoscopes used in health care settings by health care workers. The filtered ozonated final rinse water generated by the LIC Instrument Processor is indicated for the final rinsing in the LIC Instrument Processor of of heat sensitive semi-critical endoscopes used in health care settings by health care workers.

The LIC Instrument Processing System consists of a LIC Instrument Processor, a proprietary Manzi sterilant, MS10; a proprietary enzymatic Manzi Detergent, MD10; and internally generated filtered ozonated final rinse water. The LIC Instrument Processing System requires no connectors to be attached to the endoscope. The LIC Instrument Processor is a self-contained stand-alone system designed to clean and provide high level disinfection of semi-critical endoscopes using the MD10 detergent, the MS10 sterilant, and a patented push-pull agitation system. The push-pull agitation system effectively scrubs the interior and exterior surfaces of the semi-critical endoscopes without the use of special connectors. The scope is placed in a processing chamber where it is exposed to a push-pull agitation cleaning cycle that provides cleaning to a protein residual level ≤ 6.4 ug / cm², followed by hot water rinses, a push-pull agitation disinfection cycle that provides high level disinfection of the instrument being processed and final rinses with filtered ozonated water. The hardware for the LIC Instrument Processor consists of a stainless steel processing chamber, a push-pull agitation pump, an ozonator, a neutralization tank, and a variety of components that are mounted in a movable covered frame. The cleaner-processor system utilizes accessories such as disposable water filters, reusable semi-critical endoscopes trays, baffle inserts, and printer paper. The LIC Instrument Processor is designed to: (1) be used in accordance with the reprocessing instructions provided in the operator's manual of the instruments being processed, and (2) facilitate the health care facility's compliance with reprocessing guidelines published by SGNA, APIC, AORN, ASGE, CDC, and other professional organizations. MD10 is a low foaming enzyme chemical detergent packaged in single use containers for attachment to the LIC Instrument Processor. MD10 is intended to be used with the LIC Instrument Processor only. MS10 is a peracetic acid based liquid chemical sterilant packaged in single use containers for attachment to the LIC Instrument Processor. MS10 is intended to be used with the LIC Instrument Processor.

The Manzi Mach 1 Instrument Cleaner Processor System is indicated for use with the High Level Disinfectant MS10 concentrate (MEC 0.49% PAA, minimum contact temperature of 120°F for a contact time of 15 minutes) for cleaning and high level disinfecting flexible bronchoscopes used in health care settings by health care workers.

The Manzi Mach 1 Instrument Cleaner-Processor System consists of a Manzi Mach 1 Instrument Cleaner-Processor, a proprietary Manzi germicide, MS10; and a proprietary Manzi Detergent, MD10. The Manzi Mach 1 Instrument Cleaner-Processor is a self-contained stand-alone system of hardware and software designed to clean and provide high level disinfection of bronchoscopes using the MD10 detergent, the MS10 germicide, and a patented push-pull agitation system. The push-pull agitation system effectively scrubs the interior and exterior surfaces of the bronchoscope without the use of special connectors. The scope is placed in a processing chamber where it is exposed to a push-pull agitation cleaning cycle followed by two hot water rinses, a push-pull agitation disinfection cycle that provides high level disinfection (spore log reduction of > 10 ° microorganisms with no CFUs) of the device, and a final rinse with an ozonated sanitized water rinse. The hardware for the Manzi Mach 1 Instrument Cleaner-Processor consists of a stainless steel processing chamber, a push-pull agitation pump, an ozonator, and a variety of components that are mounted in a movable covered frame. The cleaner-processor system utilizes accessories such as disposable water filters, reusable bronchoscope trays, and printer paper. The Manzi Mach 1 Instrument Cleaner-Processor is designed to: ( ) be used in accordance with the reprocessing instructions provided in the operator's manual of the instruments being processed, and (2) facilitate the health care facility's compliance with reprocessing guidelines published by SGNA, APIC, AORN, ASGE, CDC, and other professional organizations. MD10 is a low foaming enzyme chemical detergent packaged in single use containers for attachment to the Manzi Cleaner. MD10 is intended to be used with the Manzi Instrument Cleaner-Processor. MS10 is a peracetic acid based liquid chemical germicide. MS10 is intended to be used with the Manzi Instrument Cleaner-Processor.

The Manzi Cleaner, when used in accordance with its labeling and the Manzi Detergent MD10, is for the cleaning of bronchoscopes in a health care setting by health care workers.

The Manzi Cleaner System consists of a Manzi Cleaner and a proprietary Manzi Detergent, MD10. The Manzi Cleaner is a self-contained stand-alone system of hardware and software designed to clean bronchoscopes using the MD10 detergent and a patented push-pull agitation system. The push-pull agitation system effectively scrubs the interior and exterior surfaces of the bronchoscope without the use of special connectors. The scope is placed in a processing chamber where it is exposed to a push-pull agitation cleaning cycle followed by two hot water rinses. The hardware for the Manzi Cleaner consists of a stainless steel processing chamber, a push-pull agitation pump, and a variety of components that are mounted in a movable covered frame. The cleaner system utilizes accessories such as disposable water filters. reusable bronchoscope trays, and printer paper. MD10 is a low foaming anionic chemical detergent packaged in custom containers for attachment to the Manzi Cleaner. The detergent is automatically diluted to a use dilution of 2.0% detergent concentration. MD10 is intended to be used exclusively with the Manzi Cleaner.