CUSTOM ULTRASONICS Scope-Assist Flushing Sink Installation instructions

MAN-100 Part Number 31062 Revision 03082022
Custom Ultrasonics
Scope-Assist Flushing Sink
Operator's and Maintenance Manual
Custom Ultrasonics, Inc.
144 Railroad Drive
Ivyland, PA 18974
215-364-1477
customultrasonics.com

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Table of Contents
1GENERAL INFORMATION ....................................................................................................3
ABBREVIATIONS ................................................................................................................................................3
WARNING/CAUTION STATEMENTS......................................................................................................................3
Warnings .................................................................................................................................................3
Cautions ..................................................................................................................................................4
INDICATIONS FOR USE/INTENDED USE ...............................................................................................................4
PRODUCT DESCRIPTION.................................................................................................................................... 4
Configurations .........................................................................................................................................5
Operating Principle.................................................................................................................................. 5
Physical Characteristics .......................................................................................................................... 5
Interfaces.................................................................................................................................................5
Assembly.................................................................................................................................................6
DIMENSIONS AND COMPONENTS........................................................................................................................6
Model S6 Dimensions .............................................................................................................................6
Model S8 Dimensions .............................................................................................................................7
Component Diagrams .............................................................................................................................8
2INSTALLATION ...................................................................................................................10
MODEL S8 INSTALLATION ................................................................................................................................10
Model S8 Installation .............................................................................................................................10
WATER SUPPLY REQUIREMENTS .....................................................................................................................10
Water Supply Installation ......................................................................................................................11
WASTE DRAIN REQUIREMENTS........................................................................................................................11
Waste Drain Installation ........................................................................................................................11
ELECTRICAL SUPPLY REQUIREMENTS ..............................................................................................................11
Electrical Supply Installation .................................................................................................................11
DETERGENT BOTTLE CONNECTION ..................................................................................................................11
Detergent Bottle Installation ..................................................................................................................11
3POST-INSTALLATION INSPECTION..................................................................................12
WATER INLET SYSTEM ....................................................................................................................................12
DRAINAGE SYSTEM .........................................................................................................................................12
DETERGENT SYSTEM ......................................................................................................................................12
PURGE SYSTEM..............................................................................................................................................12
RINSE SYSTEM ...............................................................................................................................................12
4OPERATING INSTRUCTIONS.............................................................................................13
CAUTIONS ......................................................................................................................................................13
OPERATING THE SAFS ...................................................................................................................................13
Performing the Leak Test......................................................................................................................13
Filling the Sink Basin .............................................................................................................................13
Brushing/Wiping the Endoscope Channels...........................................................................................13
Connecting an Endoscope to the SAFS ...............................................................................................13
Flushing Channels with Detergent Solution ..........................................................................................14
Drain the Detergent Solution.................................................................................................................14
Rinsing Channels with Clean Rinse Water ...........................................................................................14
Draining the Rinse Water ......................................................................................................................14
Rinsing the Endoscope Exterior and Sink Basin...................................................................................14
5MAINTENANCE ...................................................................................................................15
DAILY MAINTENANCE ......................................................................................................................................15
Operator’s Daily Checklist.....................................................................................................................15
Daily Cleaning and Decontamination ....................................................................................................15
QUARTERLY MAINTENANCE AND INSPECTION ...................................................................................................16
Visual Inspection ...................................................................................................................................16
Intake Screen Inspection.......................................................................................................................16
Adapters and Channel Flushing Port Inspection...................................................................................16
Solenoid Inspection ...............................................................................................................................16

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Detergent Pump Poppet Valves............................................................................................................18
Overflow Drain.......................................................................................................................................19
Detergent Function................................................................................................................................19
Purge Function ......................................................................................................................................19
Rinse Function ......................................................................................................................................19
Water Pressure Regulator.....................................................................................................................19
ANNUAL MAINTENANCE AND INSPECTION .........................................................................................................20
Replace Female Quick-Disconnect Fittings ..........................................................................................20
MAINTENANCE SCHEDULE ...............................................................................................................................20
6PART ORDERS....................................................................................................................20
7CONTACT INFORMATION ..................................................................................................21
ATTACHMENTS:
DISC FILTER REPLACEMENT LOG.......................................................................................A-1

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1 General Information
To obtain the Operator’s Manual and other product information, please go to the Custom Ultrasonics website:
www.customultrasonics.com. Once you are registered, a copy of the manual, and if applicable, other product
information can be download under the Product Documentation field. Adobe PDF reader is required to open and
view the document.
For users new to the website select the My Profile tab to login. Select the Register button under New Users.
Complete the required field and press the Register button. Authorized user will then be provided with a registration
confirmation email.
Abbreviations
•ASP:Authorized Service Provider
•CUI: Custom Ultrasonics, Inc.
•OEM: Original Equipment Manufacturer
•PSI: Pounds Per Square Inch
•SAFS: Scope-Assist Flushing Sink
•UDI: Unique Device Identifier
Warning/Caution Statements
A warning is a statement that alerts the user to the possibility of injury, death or other serious adverse reactions
associated with the use or misuse of the device.
A CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.
It may also be used to alert against unsafe practices or potential equipment damage. Such problems include:
malfunction, failure, and damage to the Scope-Assist Flushing Sink or damage to other property. The caution
statement includes the cautions that should be taken to avoid the hazard.
Warnings
•The Scope-Assist Flushing Sink must be turned off and unplugged before performing any service or
maintenance. Failure to do so may result in electric shock.
•The Scope-Assist Flushing Sink is not intended to nor does it solely provide cleaning or disinfection for any
endoscope processed.
•Use only endoscope adapters approved by Custom Ultrasonics.
•The Scope-Assist Flushing Sink is not designed to replace the manual flushing of the elevator recess of side-
viewing endoscopes with a syringe as specified by the endoscope manufacturer’s instructions.
•Endoscopes that have an elevator mechanism require additional manual cleaning per endoscope
manufacturer’s instructions.The operator must pay special attention during manual cleaning to adhere to
these instructions.
•Use of the Scope-Assist Flushing Sink adjacent to or stacked with other equipment should be avoided as it
could result in improper operation. If such use is necessary, this equipment and the other equipment should
be observed to verify that they are operating normally and as intended.
•Use of accessories, transducers, and cables other than those specified/provided by Custom Ultrasonics could
result in increased electromagnetic emissions or decreased electromagnetic immunity of the Scope-Assist
Flushing Sink and result in improper operation.
•Portable radio-frequency communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 12 inches (30 cm) to any part of the Scope-Assist Flushing
Sink, including cables specified by Custom Ultrasonics. Otherwise, degradation of the performance of this
equipment could result.
•The Scope-Assist Flushing Sink must NOT be located next to or near an X-Ray, CAT scan, MRI equipment,
or any other major sources of electromagnetic interference.
•The main performance of the Scope-Assist Flushing Sink has been determined to be its capability in
dispensing detergent, purging the channels, and rinsing water through the channels of an endoscope.
•If the Scope-Assist Flushing Sink is subjected to electromagnetic disturbances beyond the tested immunity
capabilities, performance may be adversely affected. If such disturbances are experienced and cause a drop
in the quality of performance, the operator should perform detergent, purge, and rinse functions again after
the disturbance has subsided.If the disturbance persists, Custom Ultrasonics should be contacted.

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Cautions
•Always follow the facility policies and procedures regarding use of personal protective equipment (face mask,
gown, gloves, etc.) when handling soiled endoscopes.
•Pulling forward or pushing back on the drain handle may cause damage. Only pull straight up and push
straight down.
•Service is only to be performed by a Custom Ultrasonics Authorized Service Provider (ASP).
•Never overload or leave the Scope-Assist Flushing Sink unattended while filling.
•Make sure the overflow plenum drain line is clear before use. The built-in overflow plenum directs water to
the drain line thereby reducing the potential for overflow.
•Always be certain that the purge/rinse functions are turned off prior to disconnecting adapters or lifting
endoscopes out of the basin.
•Failure to attach and secure all adapters may result in flushing operation failure.
•Visually confirm liquid flow through the transparent adapter tubing during flushing of endoscope’s internal
channels. No flow is an indication that there may be a blockage in the Scope-Assist Flushing Sink or within
the endoscope channel. If a blockage in the Scope-Assist Flushing Sink occurs, discontinue use and contact
Custom Ultrasonics for diagnostics and/or repair. If an endoscope channel is blocked, do not proceed;
contact the endoscope manufacturer.
•Ensure the adapters have not become disconnected from the manifold or endoscope prior to removing the
endoscope from the Scope-Assist Flushing Sink. If one or more of the adapters became disconnected,
repeat the flushing process.
•When replacing the detergent bottle and priming the detergent injection line, do not press the detergent bottle
hand pump until the detergent injection switch is engaged; damage to the detergent pump or detergent
plumbing may occur if the bottle is pumped while the detergent system is off.
•Failure to maintain proper maintenance may cause fluid overflow which may create a slip hazard and/or
create water damage.
•Endoscopes, including duodenoscopes, should be inspected and maintained as per the endoscope
manufacturer’s labeling requirements.
•When using adapters provided by the endoscope manufacturer, please check the CUI endoscope adaptation
chart and diagrams at customultrasonics.com.
•When performing leak testing in the Scope-Assist Flushing Sink, follow the endoscope manufacturer’s
instructions. If leak testing fails, contact the endoscope manufacturer.
•Dispose of all packaging materials, and the temporary storage cart for the model S8, in accordance with
facility, local, and state waste disposal regulations.
•Only Custom Ultrasonics OEM components have been validated in the Scope-Assist Flushing Sink, therefore
use only OEM components to ensure proper performance and compliance with tested standards.
•Refer to the Endoscope Flushing Matrix on customultrasonics.com for endoscope model flushing
requirements.
Note: In the event that flow is restricted in an adapter featuring a disc filter (P/N 16030), the operator is
instructed to replace the disc filter, irrespective of its in-use time, and confirm restored flow through
the adapter. If no flow is observed through the adapter, stop using the sink and call Custom
Ultrasonics for service.
Indications for Use/Intended Use
The Scope-Assist Flushing Sink is intended for flushing the channels of flexible endoscopes according to the
endoscope manufacturer’s instructions.
Warning: The Scope-Assist Flushing Sink is not intended to nor does it solely provide cleaning or disinfection for
any endoscope processed. Use only the adapters approved by Custom Ultrasonics.
Product Description
The Scope-Assist Flushing Sink is designed to mechanically assist the channel flushing portion of an endoscope’s
manual cleaning process. The sink facilitates compliance with endoscope manufacturer’s cleaning requirements by:
•Providing a means of flushing flexible endoscope channels with detergent solution
•Providing a means of flushing endoscope channels with water
•Providing an environment for soaking and manual wiping/brushing of flexible endoscope exterior surfaces
and accessories

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•Providing an environment to perform wet leak testing of endoscopes
The Scope-Assist Flushing Sink is designed:
•To be used where the facility performs its endoscope cleaning functions, such as in soiled utility rooms,
central processing decontamination areas, or endoscope cleaning (reprocessing) areas
•To be used with Tergal®800 Detergent
The Scope-Assist Flushing Sink is not designed:
•To be used at bedside, in critical care units, or in sterile environments
•To be used as a terminal process or as part of the manual high level disinfection process
Note: The Scope-Assist Flushing Sink has been validated for use with Tergal®800 Detergent. The device is
factory preset for dosing and delivery of Tergal®800 Detergent.
Warning: The Scope-Assist Flushing Sink is not designed to replace the manual flushing of the elevator recess of
side-viewing endoscopes with a syringe as specified by the endoscope manufacturer’s instructions.
Warning: Endoscopes that have an elevator mechanism require additional manual cleaning per endoscope
manufacturer’s instructions. The operator must pay special attention during manual cleaning to adhere
to these instructions.
Configurations
The Scope-Assist Flushing Sink is available in two models: the Model S6 is housed in a cabinet and is designed to
be hard plumbed and fixed in place; the Model S8 has no cabinet and is designed to be installed directly into a fixed
base cabinet with countertop or casework provided by the end user facility.
Operating Principle
The Scope-Assist Flushing Sink is a self-contained, semi-automated, manually operated, electro-mechanical
endoscope flushing sink that utilizes potable tap water and a system of pumps and solenoids to create the conditions
necessary to immerse and flush an endoscope in a detergent solution and to rinse the endoscope with potable tap
water.
Physical Characteristics
The Scope-Assist Flushing Sink consists of a stainless steel sink basin with a swinging gooseneck faucet, hot and
cold water inlet valves, and a hand spray. Advanced features include a liquid detergent injection system and a
manifold with quick-disconnect endoscope channel flushing ports.
The Model S6 is housed in a stainless steel cabinet with a standard water inlet, drain line plumbing, electrical
connections, and is shipped prepared to be permanently fixed in place.The Model S8 does not have a cabinet and
can be installed into a fixed base cabinet with countertop or casework system using its standard water inlet drain line
plumbing, and electrical connections. Both models are composed of UL listed and/or recognized electrical
components, as well as standard and/or medical grade metals, rubbers, and plastic polymers.
Interfaces
The Scope-Assist Flushing Sink’s primary users are medical technicians, nurses, and other trained health care
personnel. User interfaces include plumbing fixtures, a control panel with LED indicators, a circuit breaker, and a
manifold with quick-disconnect endoscope channel flushing ports. The environmental interface consists of a 120
VAC, 2 AMP, 60 Hz power source connection, a primary hot and cold potable tap water source connection, a
secondary cold potable tap water connection, and a connection to a primary drain within the facilities’ plumbing
system. The Scope-Assist Flushing Sink is not a required accessory to any medical device or equipment and it does
not come into contact with a patient at any time during use. In addition to the flushing of the endoscope channels,
the Scope-Assist Flushing Sink plays a passive role in the processing of endoscopes by providing an environment
where an endoscope can be leak tested, have its exterior surfaces manually wiped down, and have its connection
ports and channels brushed.

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Assembly
The Scope-Assist Flushing Sink is assembled in the United States in compliance with the Quality System Regulations
per 21 CFR 820 requirements and it is manufactured by Custom Ultrasonics, Inc. at 144 Railroad Drive, Ivyland, PA,
18974. Custom Ultrasonics, Inc. is an FDA registered and ISO 13485 certified medical device manufacturing
company.
Dimensions and Components
Model S6 Dimensions
Fig. 1.5.1-1 SAFS Model S6 Dimensions – Front
Fig. 1.5.1-2 SAFS Model S6 Dimensions – Side

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Model S8 Dimensions
Fig. 1.5.2-1 SAFS Model S8 Dimensions
Fig. 1.5.2-2 SAFS Model S8 Countertop Cut-Out Dimensions

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Component Diagrams
Fig. 1.5.3-1 SAFS Components – Front (note: the SAFS Model S6 is shown)
Fig. 1.5.3-2 SAFS Components – Back (note: the SAFS Model S6 is shown)

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Fig. 1.5.3-3 SAFS Components – Inside (note: the SAFS Model S6 is shown)
Fig. 1.5.3-4 SAFS Components – Component Enclosure