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The System 83 Revolve® Endoscope Washer/Disinfector is designed for the high-level disinfection of one or two flexible submersible endoscopes that are used in the gastrointestinal and pulmonary tracts. Flexible endoscopes that undergo bedside cleaning, are manually cleaned, and then exposed to the wash/disinfect cycle of the System 83 Revolve® may be high-level disinfected when the validated disinfection cycle of the System 83 Revolve® corresponds with the labeled contact conditions of the high-level disinfectant.

The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical. The System 83 Revolve® utilizes a processing chamber and the perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the rhannels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocessing information with a printer. Built-in sensors detect fluid levels, fluid flow, and the operating states of the components within System 83 Revolve". The system contains a Touchscreen (Graphical User Interface), a Barcode Scanner, an LED Indicator Strip that displays the process status, and a reprocessing chamber lid operation that is hands free.

The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices such as flexible endoscopes and their accessories. The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor. The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medical devices. It automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 55°C and rinses the load with 0.2-micron filtered water.

The enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS) is a medical device processing system used for cleaning and liquid chemically sterilizing immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 3000 Processor, Revital-Ox 2X Concentrate Enzymatic Detergent, S40 Sterilant Concentrate and Max Flow Connectors. The enspire 3000 Cleaning and LCSPS is an automated, self-contained device for the effective cleaning and liquid chemical sterilization of semi-critical medical devices and their accessories. The devices will not require manual cleaning prior to processing in the enspire 3000 Processor with the exception of duodenoscopes which must be manually cleaned per the manufacturer's instructions for use. In addition, prior to placement in the enspire 3000 processor, the device will undergo a manual leak test and the user will ensure the lumens are not blocked. If the device has internal channels or lumens, Max Flow Connectors are used to facilitate the delivery of detergent, sterilant use-solution and rinse water to internal channels. Once the device is positioned in the enspire 3000 processor, the unit will create and maintain the conditions necessary for effective cleaning and liquid chemical sterilization of the load. At the beginning of the processing cycle, automated pressure monitoring is performed to confirm the integrity of the flexible endoscope throughout the process. The enspire 3000 processor maintains inflation of the processed device to prevent ingress of fluid during processing and the pressure monitoring is repeated at the end of the processing cycle to ensure that the device is leak tight after cleaning and liquid chemical sterilization. At the end of the processing cycle, the cleaned and liquid chemically sterilized devices are rinsed with 0.2 micron filtered potable water followed by a HEPA-filtered air purge to aid in drying the endoscope. The processor, which is computer controlled and continually monitored, provides documentation of each cycle. The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant Concentrate is a single use chemical sterilant concentrate; its active ingredient, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, semicritical, heat sensitive medical devices such as flexible endoscopes and their accessories. The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor. The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 55°C and rinses the load with 0.2-micron filtered water.

The enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS) is a medical device processing system used for cleaning and liquid chemically sterilizing immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 3000 Processor, Revital-Ox 2X Concentrate Enzymatic Detergent, S40 Sterilant Concentrate and Max Flow Connectors. The enspire 3000 Cleaning and LCSPS is an automated, self-contained device for the effective cleaning and liquid chemical sterilization of semi-critical medical devices and their accessories. The devices will not require manual cleaning prior to processing in the enspire 3000 Processor with the exception of duodenoscopes which must be manually cleaned per the manufacturer's instructions for use. In addition, prior to placement in the enspire 3000 processor, the device will undergo a manual leak test and the user will ensure the lumens are not blocked. If the device has internal channels or lumens, Max Flow Connectors are used to facilitate the delivery of detergent, sterilant use-solution and rinse water to internal channels. Once the device is positioned in the enspire 3000 processor, the unit will create and maintain the conditions necessary for effective cleaning and liquid chemical sterilization of the load. At the beginning of the processing cycle, automated pressure monitoring is performed to assess the integrity of the flexible endoscope throughout the process. The enspire 3000 processor maintains inflation of the processed device to reduce the risk of ingress of fluid during processing and the pressure monitoring is repeated at the end of the processing cycle. At the end of the processing cycle, the cleaned and liquid chemically sterilized devices are rinsed with 0.2 micron filtered potable water followed by a HEPA-filtered air purge to aid in drying the endoscope. The processor, which is computer controlled and continually monitored, provides documentation of each cycle. The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant Concentrate is a single use chemical sterilant concentrate; its active ingredient, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

SCOPE BUDDY PLUS Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing.

The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. The minimum fluid volumes are defined by the endoscope manufacturer. SCOPE BUDDY PLUS Endoscope Flushing Aid is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver a volume of fluid to the endoscope channels which exceeds the minimum fluid volumes specified by the endoscope manufacturer. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.

The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the OER-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite.

The OER-Elite Endoscope Reprocessor is an automated endoscope reprocessor intended for high-level disinfection of Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories, utilizing both a detergent and FDA cleared high-level disinfectant validated by Olympus to be efficacious and compatible with the materials of the OER-Pro and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. The OER-Elite originally featured an "extra disinfection process" which can provide an extra three-minute process for delivering fluid to both the forceps elevator area and elevator wire channel when reprocessing endoscopes with a forceps elevator. The software of the OER-Elite was changed to apply the "extra disinfection process" to the ultrasound endoscope with balloon channel in addition to the endoscopes with a forceps elevator. The proposed OER-Elite differs from the predicate OER-Elite in the following minor modifications: Add "Extra disinfection process" to ultrasound endoscope with balloon channel. Optimize the threshold values of existing error codes. Replace the electronic cooling fan due to discontinuing of the product. Change the material used for fluid pathways. The OER-Elite is a one-basin automatic endoscope reprocessor that performs leak testing, cleaning, disinfection, rinsing, and an alcohol flush to render a high-level disinfected endoscope, their accessories, and endoscope reprocessor accessories. The OER-Elite utilizes an immersion method for cleaning, disinfecting, and rinsing of endoscope and accessory external surfaces, and connectors for endoscope channel cleaning, disinfecting, and rinsing. Two endoscopes, with several exceptions, can be reprocessed simultaneously in the basin during one reprocessing cycle. The OER-Elite's cleaning cycle includes ultrasonic cleaning. which helps remove debris and dirt from endoscope surfaces. The OER-Elite is capable of fully automated detergent/disinfectant solution dispensing and alcohol/air drying of endoscope channels. The 0.2-micron air/water filters are bacteria retentive and produce suitable rinse water and air for reprocessing. Built-in sensors detect fluid levels, fluid temperature, air/fluid pressure, fluid flow, and the operating states of the components within the OER-Elite. The OER-Elite is also equipped with a RFID (Radio-Frequency Identification) function. With a built-in antenna, the OER-Elite is capable of reading user and scope ID data from the proprietary ID tag/chip. The scope/user ID information and each reprocessing result can be printed out with a built-in printer, displayed on a touch screen, or exported to a portable memory. The OER-Elite is capable of using a concentrated disinfectant (e.g., Acecide-C) sealed in dedicated cassette bottles. The concentrated disinfectant is automatically diluted by filtered water until it reaches a specified quantity in the device.

System 83 Plus™ Washer/Disinfector is designed for the simultaneous high level disinfection of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible endoscopes that are precleaned and manually cleaned, and then exposed to the washing /disinfection cycle of the System 83 Plu s™, may be high level disinfected when the disinfection cycle corresponds to the System 83 Plus™ validated contact conditions of the high level disinfectant. Note: The System 83 Plus™ device includes two models. · The System 83 Plus™ 2 has one processing chamber that can process 1 to 2 flexible endoscopes at a time . · The System 83 Plus™ 9 has two processing chambers that can process 1 to 2 flexible endoscopes at a time in each independently operated processing chamber for a total of up to 4 endoscopes simultaneously.

The System 83 Plus™ is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes (per bay) utilizing a detergent and FDA cleared high-level disinfectant validated by CUI. The System 83 Plus™ device family includes two models. The System 83 Plus™ 2; a model with one processing chamber, which can process one to two flexible endoscopes at a time. The System 83 Plus™ 9: a model with two processing chambers which can asynchronously reprocess up to 2 endoscopes per bay (total of up to 4 endoscopes). The System 83 Plus™ utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high level disinfected endoscope. The System 83 Plus™ is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the channels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocessing information with a printer. Built-in sensors detect fluid levels, fluid temperature, fluid flow, and the operating states of the components within System 83 Plus™.

The OER-Elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Elite and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and can damage the OER-Elite components and the endoscopes being reprocessed. Endoscopes must be cleaned by the user prior to reprocessing; however, use of the OER-Elite enables the user to perform modified manual cleaning of some endoscopes prior to automated cleaning and high-level disinfection in the OER-Elite.

The OER-Elite Endoscope Reprocessor is an automated endoscope reprocessor intended for high-level disinfection of Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories, utilizing both a detergent and FDA cleared high-level disinfectant validated by Olympus to be efficacious and compatible with the materials of the OER-Pro and Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. The OER-Elite is a one-basin automatic endoscope reprocessor that performs leak test, cleaning, disinfection, rinse, and alcohol flush to render a high-level disinfected endoscope, their accessories, and endoscope reprocessor accessories. The OER-Elite utilizes an immersion method for cleaning, disinfecting, and rinsing of endoscope and accessory external surfaces, and connectors for endoscope channel cleaning, disinfecting, and rinsing. Two endoscopes, with several exceptions, can be reprocessed simultaneously in the basin during one reprocessing cycle. The OER-Elite's cleaning cycle includes ultrasonic cleaning, which helps remove debris and dirt from endoscope surfaces. The OER-Elite is capable of fully automated detergent/disinfectant solution dispensing and alcohol/air drying of endoscope channels. The 0.2-micron air/water filters are bacteria retentive and produce suitable rinse water and air for reprocessing. Built-in sensors detect fluid levels, fluid temperature, air/fluid pressure, fluid flow, and the operating states of the components within the OER-Elite. The OER-Elite is also equipped with a RFID (Radio-Frequency Identification) function. With a built-in antenna, the OER-Elite is capable of reading user and scope ID data from the proprietary ID tag/chip. The scope/user ID information and each reprocessing result can be printed out with a built-in printer, displayed on a touch screen, or exported to a portable memory. The OER-Elite is capable of using a concentrated disinfectant (e.g., Acecide-C) sealed in dedicated cassette bottles. The concentrated disinfectant is automatically diluted by filtered water until it reaches a specified quantity in the device.

The ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor is indicated for use with high-level disinfectant ASP AERO OPA™ ortho-Phthalaldehyde Solution to achieve high-level disinfection of flexible semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the AER.

The AEROFLEX Automatic Endoscope Reprocessor (AER) with AUTOSURE MRC Monitor is designed to provide high-level disinfection for flexible, submersible endoscopes that have been manually cleaned. The AEROFLEX system consists of the software-driven AER, the AUTOSURE MRC reagent, AERO-OPA™ disinfectant solution, and AEROZYME™ enzymatic detergent. The AEROFLEX AER with AUTOSURE MRC Monitor is indicated for use with high-level disinfectant ASP AERO-OPA ortho-Phthalaldehyde Solution to achieve high-level disintection of semi-critical endoscopes; high-level disinfection requires that the AER be used with the AERO-OPA Solution per its Instructions for Use. Manual cleaning of endoscopes is required prior to placement in the AEROFLEX AER. After an endoscope is manually cleaned according to its manufacturer's recommended procedures, it is loaded into the AER. After starting the reprocessing cycle, the AER displays its progress during the cycle and signals that the cycle is complete on the control panel and with an audible tone. The minimum recommended concentration (MRC) of ASP AERO-OPA ortho-Phthalaldehyde Solution is automatically checked and verified by the AER for every cycle using an integrated MRC monitor and reagent. The MRC monitor- tests the OPA concentration in every high-level disinfection cycle without the use of test strips; if the OPA concentration is below the MRC the system cancels the cycle and notifies the user. To reduce user error and facilitate assurance of disinfection efficacy, the AEROFLEX System uses Radio Frequency Identification (RFID) technology to identify the ASP-branded consumables that are used with the system. Additionally, to enable electronic record-keeping by hospitals, the AEROFLEX system can be configured by users to transmit cycle printout information and/or print cycle records from the facility's network; the AEROFLEX System will also be compatible with ASP ACCESS™ Technology to allow automated record keeping.

The Acu-sInQ Complete Endoscope Cleaning Aid System is intended to assist manual flexible endoscope cleaning according to the instructions provided by the endoscope manufacturer, by facilitating performance of a leak test, accurate detergent dosing with water temperature monitoring, channel flushing, rinsing, and process documentation.

The Acu-sInQ Complete Endoscope Cleaning Aid System is used in the reprocessing room of a hospital or endoscopy center, and aids technicians by providing a step-by-step cleaning sequence of flexible endoscopes for process management and reports. The Acu-sInQ Complete Endoscope Cleaning Aid System is a 4-in-1 system with automated scope inflation for performance of a leak test, precision chemical dosing, and automated channel flushing with pulsating fluid technology for main and auxiliary flush ports. The System also provides: Data management via printout with every cycle, USB drive and port output for capture and recording of process data and chemical usage, Software to enable transfer of data between system and Customer's PC, Barcode scanner to input endoscope serial number and technician ID which aids in documentation process, Pre-loading with Customer's endoscope inventory.