Frequently Asked Questions

What’s the advantage of a channel monitoring feature in an AER?

State-of-the art AERs with channel monitoring capability utilize sensors to detect blocked channels as well as kinked or collapsed adapter tubes which would otherwise restrict adequate flow of solution to endoscope channels. If an AER does not feature channel monitoring, then during the manual pre-cleaning stage the end user is solely responsible for ensuring that all internal channels are unblocked/unclogged (BEFORE attempted automated reprocessing) because if a channel is blocked successful high-level disinfection (or liquid chemical sterilization) will not be possible by any AER or process.

Can I use any disinfecting solution in a System 83 Plus washer-disinfector?

Any legally marketed liquid chemical high-level disinfectant including oxidizing chemistries recognized as compatible by the device (endoscope) manufacturer and acknowledged as compatible by Custom Ultrasonics with System 83 Plus washer-disinfectors can be used for automated reprocessing.

(Contact Custom Ultrasonics before replacing one type of liquid chemical germicide or detergent with another)
 

How do I know which adapters are required to reprocess my flexible endoscopes?

Channel connectivity for all scopes in inventory should be reviewed during the initial unit in-service. To confirm the recommended channel adapters for a particular brand and model instrument, please refer to the Endoscope Adaptation Charts such as those available at www.customultrasonics.com. Endoscope Connection Diagrams are also available illustrating the appropriate connection of channel adapters. Whenever in doubt, always check with CU to confirm the correct connections between endoscope and AER. (Contact Custom Ultrasonics when a new scope is purchased)

Does it matter which AER manifold ports are used to connect to my scope channel adapters?

A. Yes, certain difficult to flow endoscope channels such as restrictive elevator wire and long, narrow auxiliary/water jet channels require high pressure ports to consistently deliver appropriate fluid flow. System 83 Plus includes a double row of outlet ports in its manifold with the two lower ports dedicated for high pressure delivery of fluid.
(For non-channel monitoring units connect adapters to the CU AER manifold always starting from the far right side, moving left and without skipping ports. Ensure all adapters used are connected to a scope. If reprocessing only one scope, disconnect any unused scope adapters. Channel monitoring systems require that every port in the manifold have an adapter. Note that the two high pressure ports located beneath the main manifold have special fittings and if not connected properly an error message (“Water Channel Warning”) will be displayed.)

Never operate any CU unit without at least three adapters plugged into the manifold.

Does CU recommend any particular detergent for cleaning endoscopes during the wash cycle in System 83 Plus?

CU recommends the use of Tergal 800 alkaline detergent because this specific solution has been tested and its cleaning performance validated in System 83 Plus. Detergents other than Tergal 800 may be used provided (1) they are specifically formulated for ultrasonic cleaning, (2) they are compatible with the components of the endoscope and System 83 Plus, and (3) validated simulated in-use data exist demonstrating the detergents’ effectiveness when used to clean endoscopes during worst-case conditions.

Are the endoscopes completely immersed in both detergent and disinfectant during the wash and high-level disinfection cycles?

Yes, in each stage including cleaning, disinfection and rinsing all portions of the endoscope are completely immersed and fully exposed to reprocessing solutions. Additionally, during all cycles solution is flushed through all endoscope channels.

Can System 83 Plus AERs reprocess ultrasound endoscopes? Two-instrument channel scopes? Exposed elevator wire channels in instruments such as duodenoscopes?

Yes, ultrasound scopes , perhaps the most complex of all flexible endoscopes, dual-instrument channel scopes also quite challenging in terms of reprocessing and exposed elevator wire channels, traditionally recognized as being extremely difficult to reprocess can all be reprocessed in System 83 Plus. (Refer to the CU-made Endoscope Adaptation Charts to confirm the recommended channel connections for each specific model instrument)

Why do so many channel adapters have to be connected to the CU AER?

Unlike some other products which utilize bifurcated or multi-branched adapter tubes, CU has always been an avid proponent of one-on-one channel adapters to ensure optimum flow to each/every channel. Without such individualized channel connections, the laws of physics come into play and fluid will take the path of least resistance and flow primarily through the larger sized channels. This may not ensure adequate perfusion of smaller size channels inherently having increased resistance to flow.

Why is it that CU AERs have no automated leak test feature?

CU believes that automated leak testing found in AERs have inherent limitations and shortcomings. First, such automated testing does not allow instruments to be tested consistent with endoscope OEM instructions calling for deflection of the distal bending section. Without such flexing and stretching of the distal sheath, tiny “pinhole” leaks may not be detected. Secondly, instructions from these same AERs state that automated leak testing is not a replacement for manual leak testing per OEM recommendations (and manual leak testing should still be performed). Thirdly, the sealed leakage tester connector used in AERs prevents contact of germicide with potentially contaminated surfaces of the scope venting/leak test connector – so, if this connector is contaminated before automated reprocessing, it will remain contaminated.

Do System 83 Plus disinfectors offer a bar code option to simplify scope identification and tracking?

A separate Endoscopy Management System (EMS) software platform offered by CU used in conjunction with System 83 Plus employs bar code technology to easily identify instruments, link them to patients and staff and track inventory throughout all endoscopy activities, including instrument reprocessing. EMS, an automated software-based system provides instantaneous data on equipment utilization, helps ensure compliance with institutional SOPs, and is a key tool in the establishment and maintenance of an effective Quality Assurance and Safety Program to manage busy endoscopy environments.

Can TEE probes be reprocessed in System 83 Plus?

Yes, generally speaking TEE probes can be reprocessed utilizing a special lid with cut out section to keep the non-immersible control section out of fluid while immersing only the insertion (tube) portion of the probe. As with traditional flexible endoscopes, each specific brand and model of probe should be evaluated to confirm its individual reprocessing requirements, so check with CU before reprocessing a specific probe.

Why shouldn’t I use filters purchased from sources other than CU?

Only CU recommended water filters should be used because CU validation studies and all data submitted to the FDA have been based solely upon CU specified filters and components. Additionally, the FiberFlo 0.1 micron absolute rated bacteria retentive hollow fiber filter is of itself a medical device and has its own 510K for endotoxin removal and has been validated to remove 100% of endotoxins at levels up to 1EU/ml. (Endotoxins, a form of a pyrogen, a fever producing agent are the remnants of cell walls of gram negative bacteria.)

What’s the benefit of a CU scope storage cabinet?

Besides providing secure protection of your valuable endoscopic instrumentation, the cabinet contains an adjustable timer controlled air pump to circulate air through the endoscopes’ internal channels to facilitate channel drying. It serves as an ideal storage environment free of water-absorbent materials to minimize recontamination risks from bacterial or fungal growth.

Can miscellaneous items be reprocessed in the disinfectant reservoir?

NO! Do not place any items to be disinfected in the chemical reservoir. And, do not attempt to reprocess water bottles, syringes, sponges, containers, etc. along with the endoscope in the processing chamber.

What are some basic installation requirements for a dual bay System 83 Plus 9 unit?

Electrical Requirements: 120V, 20 A, 60HZ
Water Pressure: 40 – 50 PSI
Water Flow Requirements: 8 - 10 GPM
Water Temperature (Incoming): 105 - 115ºF
Water Hardness Potable: Tap Water
Water Supply: Dedicated ¾ in Hot & Cold Supply Lines with shut-off valve and ¾ in male garden hose adapters
Waste Drain (recommended): One 2 in diameter standpipe, ~18” AFF
Dimensions (W x D x H): 68 x 34 x 36.5 in
 

How would a CU Pre-Processing Sink help my cleaning staff?

CU Sinks provide an ideal working environment to perform all pre-processing activities – an extremely large basin allows safe placement and full immersion of even the largest of flexible endoscopes without excessive coiling which facilitates channel cleaning by brush. Manual leak testing including deflection of the distal bending section consistent with OEM recommendations can be performed and all external instrument surfaces can be mechanically cleaned easily. To prevent hand injuries or fatigue due to repetitive syringe flushing, all internal scope channels can be simultaneously perfused with detergent solution using the sink’s built-in pump purging capabilities. To simplify and standardize the transition from manual cleaning to automated disinfection, the same channel adapters can remain attached to the scope and placed directly in the AER so they along with the endoscope can be reprocessed together.
(For non-channel monitoring units, manually confirm the patency of each channel to ensure there are no scope blockages during the manual cleaning process in the Pre-Processing Sink)
 

What’s the big deal about ultrasonic cleaning?

Ultrasonics technology has been long recognized as a most effective cleaning method in healthcare and non-medical fields. Since 1979 CU has safely utilized low intensity sound waves with flexible endoscopes to set into very rapid motion the molecules of water and detergent and create bubbles. When these microscopic bubbles reach critical mass, they implode and create a vacuum that removes contaminants from endoscope surfaces including crevices which may not be readily accessible or areas containing obscure debris. This cavitation process literally dislodges soil from contaminated surfaces and crevices.

Why do CU AERs have high-pressure ports?

High-pressure ports ensure that there is consistent and adequate flow of reprocessing fluids into extremely narrow lumens, longer-length channels and/or lumens with restricted space. Traditionally, elevator-wire channels have been recognized as being most difficult to reprocess due to the additional pressures required to generate sufficient fluid flow through such a channel most of whose volume is occupied by a multi-stranded control wire. Long length water jet channels may also present more of a challenge especially when one-way check-valve mechanisms with high cracking pressures are within the fluid pathway.

Does CU have microbiological validation data to support its reprocessing claims?

Yes, to support its 510K submission for System 83 Plus CU sponsored independent laboratories to perform microbiological simulated-use studies using worst case scenarios and not only provided this data to the FDA but published it in a Summary and Overview Booklet. Using a patented site specific test protocol data demonstrating effective cleaning and high-level disinfection was obtained for individual channels, external scope surfaces as well as instrument components (ex. valves). As more complex instruments have been developed, CU has performed additional microbiological studies supporting its reprocessing claims under worst-case conditions for these more challenging multi-channeled flexible endoscopes (certain ultrasound scopes) which have more than 5 internal channels, including an exposed elevator wire channel.