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FDA Grants Clearance to Langford IC Systems, Inc.
Date:10/12/2007

icide Cycle: The Manzi system does not use connectors, resulting in full exposure of all instrument surfaces to the sterilizing germicide. This cycle sanitizes to a resulting Sterility Assurance Level (SAL) of >6 with no surviving Colony Forming Units (CFU's).

Rinsing Cycle: The Manzi system includes a patented, integrated water purification system that provides a final rinse of Sanitized Rinse Water(TM) that will not compromise the integrity of the sterilization process.

Introduction of the Manzi system addresses several organizational and efficiency issues, not addressed by existing technology. The Manzi system is designed to be on-site and at point of use. This permits medical facility control over the operator and operator training, the instrument supply chain, and physical monitoring of the cleaner-processor device. Additionally, the on-site reprocessing time cycle is approximately 45 minutes. This is a significant reduction of time compared to off-site or central supply reprocessing.

The advanced capabilities of the Manzi system are a proactive response to improve the chain of patient care. Between five and 10% of patients admitted to hospitals in the United States develop hospital-acquired infections (nosocomial infections). Governmental agencies are focusing efforts to reduce such infections by imposing new Medicare regulations and hospital reporting laws. Hospitals will no longer receive additional payment for costs associated with a patient's hospital acquired infection. Fourteen states already require reporting of these infection rates. The Manzi device will greatly reduce the risk of patient exposure to certain pathogen residue on medical instruments and the potential resulting infections.

Langford IC Systems, Inc.'s mission is to utilize advanced technology to provide the Healthcare Industry with affordable, easy to operate, cleaner-processors that safely and effectively reprocess medical devices, instruments, and implantable(s).
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SOURCE Langford IC Systems, Inc.
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