The System 83 Plus™ Washer-Disinfector:
- is the only automated endoscope reprocessor (AER) to date cleared by the FDA as a terminal process for which data demonstrating it effectively both washes and high-level disinfects heat-sensitive, submersible flexible endoscopes have been published (i.e., data are available that demonstrate at least a 3 log and 6 log reduction of bioburden for each of the endoscope’s channels, external surfaces, and valves during the washing and high-level disinfection phases, respectively). The System 83 Plus™ uses a validated process to standardize each reprocessing phase.
- was tested using a patented, simulated in-use microbiological decontamination protocol under worst-case conditions (U.S. Patent, No. 6,428,746). Unlike ASTM’s decontamination standards, this patented protocol is not prone to “false-negative results.
- irrigates each of the endoscope’s channels during each reprocessing phase. The System 83 Plus™ provides one channel-tubing adapter for each endoscope channel. In contrast, the “all-channel irrigator is bifurcated and delivers flow to the endoscope channel of least resistance (i.e., the suction channel) and, therefore, may not ensure adequate flow of the LCS to channels of greater resistance (i.e., the air/water channels).
Note: During reprocessing, visual confirmation of fluid flow into each endoscope channel via each channel-tubing adapter is necessary. Failure to confirm flow through each of the endoscope’s channels during automated processing may result in adverse consequences.
- designed to be used with virtually every FDA “approved LCS on the market (refer to: http://www.fda.gov/cdrh/ode/germlab.html).
Note: Contact Custom Ultrasonics, Inc. before replacing one type of LCS with another.
- is computer-controlled and features a keyboard and video display monitor for displaying its user-friendly graphic-user-interface. This keyboard can be used with a cover.
- features a computer-controlled timer that ensures the endoscope is immersed in the detergent and LCS for the recommended time. Failure to immerse the endoscope in the detergent and LCS for the recommended time may result in adverse consequences.
- features a computer-controlled heater that elevates the temperature of the LCS as may be required by its labeling. During reprocessing, the temperature of the LCS is monitored as it flows through the endoscope’s internal channels. Failure to use the LCS at the recommended temperature may result in adverse consequences.
- features an optional third water rinse that follows high-level disinfection. This third water rinse may be required, per the LCS’s labeling. The System 83 Plus™ is designed to ensure the proper fluid level for complete immersion of the endoscope. Failure to rinse the endoscope with water for the proper number of times, at the recommended volume, and for the recommended time may result in adverse consequences.
- features “low-pressure outputs designed to irrigate the endoscope’s suction and air/water channels, at a maximum pressure of approximately 22-25 pounds-per-square-inch (PSI).
- features a “high-pressure pump designed to irrigate the endoscope’s narrower and harder-to-reprocess accessory channels—such as, the colonoscope’s auxiliary water jet channel and the side-viewing duodenoscope’s elevator-wire channel—at a maximum pressure of approximately 35 PSI.
Note: Verification of fluid flow through each of the endoscope’s channels, including the ERCP duodenoscope’s elevator-wire channel, is essential, to ensure proper reprocessing and patient safety. Provided the elevator-wire channel has been properly pre-cleaned and has been determined by the facility not to be obstructed, occluded, or damaged, published ow) indicate that the elevator-wire channel of tested endoscope models can be reprocessed using the System 83 Plus™. Alternatively, the elevator-wire channel can be manually reprocessed in accordance with the duodenoscope’s reprocessing instructions, followed in sequence by reprocessing the entire duodenoscope, including its exterior, valves, and other channels and surfaces using the System 83 Plus™, with the elevator-wire channel connected to the System 83 Plus™ via the proper channel-tubing adapter.
- features stainless steel internal components, to ensure compatibility with most oxidizing (and aldehyde-based) LCSs.
- features a printer and database that document each cycle's reprocessing parameters, such as the LCS’s immersion time and temperature; the physician's name; the patient's name; the endoscope's manufacturer, model and identification (or serial) number; the date; and the duration of each reprocessing cycle. Failure to print-out these reprocessing parameters and include this documentation in the patient’s medical file may hinder an investigation in the event an infection or outbreak is identified.
- is used in conjunction with a water filtration assembly. This assembly typically includes a 5 micron sediment pre-filter and 0.1 micron bacterial post-filter. This assembly may also include a 25 micron pre-filter, depending on the quality of the facility’s water.
Note 1: Use of the water filtration assembly supplied by Custom Ultrasonics, Inc. is recommended. Contact Custom Ultrasonics, Inc. before purchasing a bacterial filter from another manufacturer or vendor. Some bacterial filters are not 510(k)-cleared by the FDA, but may instead be only “constructed of 510(k)-cleared materials, which is insufficient. Use of a bacterial filter that has not received 510(k) clearance by the FDA for the specific application of reprocessing endoscopes (or, for example, for use with hemodialyzers) is not recommended. Use of improper water filters may have adverse consequences. Moreover, proper replacement and insertion of the water filters, as well as proper maintenance and decontamination of the water filtration assembly’s housing, are important to the production of bacteria-free rinse water as required. (Refer to the System 83 Plus’s™ operator’s manual for more information).
Note 2: The System 83 Plus™ and its water filtration assembly are recommended for use with potable tap water. Use of the System 83 Plus™ is contraindicated whenever the quality of the facility’s tap water is compromised and requires boiling before drinking due to, for example, a natural disaster, such as a hurricane and associated flooding. Use of the System 83 Plus™ for reprocessing endoscopes may resume once water drinking restrictions have been removed. Contact Custom Ultrasonics, Inc. for more information.
- is designed to rinse each of the endoscope's internal channels with 70% alcohol, to facilitate drying after completion of the reprocessing cycle.
- features an air compressor that removes most of the rinse water from the endoscope’s channels after each reprocessing phase. Manual activation of this air compressor for extended drying after completion of the reprocessing cycle may be necessary, depending on the endoscope model. This air compressor is designed to be used in conjunction with a 70% alcohol rinse. Use of an external (medical grade) compressed air source may be necessary before storage to thoroughly dry endoscopes with long internal channels. Failure to dry the endoscope after reprocessing may have adverse consequences.
Note: Air bubbles produced by this air compressor after each reprocessing phase and during 70% alcohol rinsing can be used to visually confirm fluid flow through each channel-tubing adapter, as required to ensure proper reprocessing of each endoscope channel.
- features a pressure sensor to ensure proper operation of the re-circulating fluid pump.
- achieves high-level disinfection of its internal components, solenoids, and plumbing lines during routine endoscope reprocessing. Periodically scheduled “auto-disinfection/sterilization of the internal components, solenoids, and plumbing lines of the System 83 Plus™ is still required, such as when changing the bacterial filter. Refer to the System 83 Plus’s™ operator instructions. Contact Custom Ultrasonics, Inc. for more information. Failure to perform this procedure as recommended may have adverse consequences.
Note: Although the System 83 Plus™ Washer-Disinfector is a stand-alone reprocessor that both washes and high-level disinfects immersible heat-sensitive endoscopes, it is designed to be used in conjunction with: (1) a pre-processing sink that flushes each of the endoscope’s channels with detergent during manual pre-cleaning and brushing; and (2) a drying cabinet that provides proper ventilation and continuously purges each of the endoscope’s channels with forced air during storage, to prevent bacterial colonization.