CUSTOM ULTRASONICS 83 Plus System 2 User manual

MAN-202 Revision 03082022 P/N 13167
Custom Ultrasonics, Inc.
System 83 Plus™ Washer/Disinfector
Service Manual
Custom Ultrasonics, Inc.
144 Railroad Drive
Ivyland, PA 18974
215-364-1477
customultrasonics.com

System 83 Plus™ Washer/Disinfector
Service Manual
MAN–202 Revision 03082022 Page 2 of 54
Table of Contents
Abbreviations, Warnings, and Cautions.................................................................................................................. 5
Abbreviations ..................................................................................................................................................5
Warning and Caution Statements...................................................................................................................6
Labels and Label Indication ............................................................................................................................ 8
Introduction .............................................................................................................................................................. 11
Indication for use ..................................................................................................................................................... 11
Detergents .................................................................................................................................................... 12
High Level Disinfectant (HLD) ......................................................................................................................12
Electrical Safety ............................................................................................................................................12
Electrical Rating ............................................................................................................................................ 12
Physical Description of System 83 Plus™....................................................................................................12
Site Requirements ................................................................................................................................................... 13
Electrical Requirements.............................................................................................................................13
Water Requirements...................................................................................................................................13
Waste Drain Requirements........................................................................................................................13
Installation Requirements ....................................................................................................................................... 14
In-Service Training Requirements ................................................................................................................ 14
Service Personnel Qualifications ........................................................................................................................... 14
Preventative Maintenance Requirements.....................................................................................................14
Warranty Requirements .......................................................................................................................................... 14
Navigating the Software Program .......................................................................................................................... 15
Logging In ..................................................................................................................................................... 15
Main Menu Screen........................................................................................................................................ 15
Reports Screen ............................................................................................................................................. 16
Process Info Screen ..................................................................................................................................... 16
Service Screen .............................................................................................................................................17
Quarterly Preventative Maintenance...................................................................................................................... 18
External Inspection of the System 83 Plus™ ...............................................................................................18
Process Info Log Review ..............................................................................................................................18
Service Screen Component Testing.............................................................................................................19
Water Solenoid .............................................................................................................................. 19
Ultrasonics ..................................................................................................................................... 19
Drain/HLD Return Pump ................................................................................................................ 19
Drain Solenoid ............................................................................................................................... 19
Purge Pump ................................................................................................................................... 19
HLD Feed Pump ............................................................................................................................ 19
HLD Feed Solenoid........................................................................................................................ 19
HLD Return Solenoid ..................................................................................................................... 19
Residual Drain Pump and Solenoid............................................................................................... 20
Air Pump and Solenoid .................................................................................................................. 20
Detergent Pump and Solenoid....................................................................................................... 20
Disinfectant Reservoir Heat Pad.................................................................................................... 20
Processing Chamber Heat Pad ..................................................................................................... 20
Service Screen Input Sensor Testing ...........................................................................................................20
Flow Sensor ................................................................................................................................... 20
Float Sensor................................................................................................................................... 20
Safety Float Sensor ....................................................................................................................... 20
Ultrasonics Sensor......................................................................................................................... 21
Water Channel Sensor................................................................................................................... 21
Temperature Control Component Testing .................................................................................................... 21
Disinfectant Reservoir Heat Float .................................................................................................. 21
Disinfectant Reservoir Thermal Break ........................................................................................... 21
Processing Chamber Thermal Break............................................................................................. 21
Disinfectant Reservoir Thermocouple............................................................................................ 21
Processing Chamber Thermocouple ............................................................................................. 21

System 83 Plus™ Washer/Disinfector
Service Manual
MAN–202 Revision 03082022 Page 3 of 54
Ventilation Sensors.......................................................................................................................................22
Filter Screen Inspection ................................................................................................................................23
Manual Switch Testing..................................................................................................................................23
Rinse Switch .................................................................................................................................. 23
Air Switch ....................................................................................................................................... 23
High Pressure Channel Monitoring Override Switch ..................................................................... 24
Power Lid and Foot Pedal Switches .............................................................................................. 24
Function Testing ...........................................................................................................................................24
Ultrasonics Testing and Triple Water Filtration System Pressure Differential Check.................... 24
Adapter Inspection ......................................................................................................................... 25
Water Channel Testing .................................................................................................................. 25
Air/Alcohol Purge Testing .............................................................................................................. 25
Printer Testing................................................................................................................................ 26
Solenoid Valve Testing .................................................................................................................................26
Solenoid Valve Inspection and Cleaning ....................................................................................... 26
Internal Filters and Backpack Filter ..............................................................................................................26
100 Micron Capsule Filter .............................................................................................................. 26
HEPA Filter .................................................................................................................................... 26
Backpack (Charcoal) Filter............................................................................................................. 26
Disinfection Procedure for the Alcohol Line and Detergent Line..................................................................27
Equipment ...................................................................................................................................... 27
Alcohol Line Disinfection................................................................................................................ 27
Detergent Line Disinfection............................................................................................................ 27
Biannual Preventative Maintenance ...................................................................................................................... 28
Pumps...........................................................................................................................................................28
Flow Probe.................................................................................................................................................... 28
Annual Preventative Maintenance ......................................................................................................................... 28
Processing Chamber Bulkheads .................................................................................................................. 28
Air Pump Intake Filter ...................................................................................................................................28
Five Year Preventative Maintenance...................................................................................................................... 28
Ultrasonic Generator.....................................................................................................................................28
Water Inlet Filtration System .................................................................................................................................. 29
25 and 5 Micron Filter Replacement Procedure ...........................................................................................29
Required Tools............................................................................................................................... 29
Required Parts ............................................................................................................................... 29
Optional Parts ................................................................................................................................ 29
Filter Replacement......................................................................................................................... 29
0.1 Micron Filter Replacement and Disinfection Procedure .........................................................................30
Required Tools............................................................................................................................... 30
Required Parts ............................................................................................................................... 30
Optional Parts ................................................................................................................................ 30
Filter Replacement and Disinfection .............................................................................................. 30
Cables and Connections ......................................................................................................................................... 32
Post-Preventative Maintenance Testing................................................................................................................ 33
Post-Preventative Maintenance Test Cycle..................................................................................................33
Part Replacement Instructions............................................................................................................................... 34
Power............................................................................................................................................................34
Solenoid Valves ............................................................................................................................................34
Solenoid Valve Component Inspection.......................................................................................... 34
Solenoid Valve Replacement......................................................................................................... 36
Air Solenoid Rebuild Kit Replacement (P/N 71235P3R) ..............................................................................36
Detergent Solenoid Rebuild Kit Replacement (P/N 6-606R)........................................................................37
Hand Spray Solenoid Rebuild Kit Replacement (P/N 6-606R).....................................................................37
HLD Feed and HLD Return/Drain Solenoid Rebuild Kit Replacement (P/N 12-606R) ................................38
Residual Drain Solenoid Rebuild Kit Replacement (P/N 623-606R) ............................................................39
Water Inlet Solenoid Rebuild Kit Replacement (P/N 06-1019R) ..................................................................39
100 Micron Capsule Filter Replacement (P/N 11087)..................................................................................40
HEPA Filter Replacement (P/N 13075) ........................................................................................................40
Charcoal Filter Replacement (P/N 21017)....................................................................................................41
Drain/HLD Return Pump Impeller (P/N 11009) and Pump Shaft (P/N 11135) Replacement ......................41
HLD Feed Pump Impeller (P/N 11009) and Pump Shaft (P/N 11135) Replacement...................................42

System 83 Plus™ Washer/Disinfector
Service Manual
MAN–202 Revision 03082022 Page 4 of 54
Flow Probe Replacement (P/N 12002).........................................................................................................43
Female Adapter Ports Replacement (P/N 18022) ........................................................................................43
Air Pump Intake Filter Replacement (P/N 20010) ........................................................................................44
Ultrasonic Generator (P/N 12008) and Signal Circuit Board (P/N 12073) Replacement .............................45
Attachment A
Preventative Maintenance Schedule Checklist....................................................................................................... 1

System 83 Plus™ Washer/Disinfector
Service Manual
MAN–202 Revision 03082022 Page 5 of 54
NOTE: To obtain the Operator’s Manual and other product information, please go to the Custom Ultrasonics
website: customultrasonics.com. Once you are registered, a copy of the manual, and if applicable,
other product information can be downloaded 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 users will then be
provided with a registration confirmation email.
Technical Bulletin Link
Links to Technical Bulletins are available under the Product Documentation tab on the Custom Ultrasonics website
at: customultrasonics.com.
Abbreviations, Warnings, and Cautions
Abbreviations
•± = More than or less than
•°C = Degree reading in Celsius (after number for temperature)
•°F = Degree reading in Fahrenheit
•AC = Alternating Current
•AMP = Amperage
•BTU = British Thermal Unit
•C = Celsius
•CC = Cubic Centimeters
•DC = Direct Current
•ESD = Electro Static Discharge
•F = Fahrenheit
•GFCI = Ground Fault Circuit Interrupt
•GPM = Gallons per minute
•HEPA = High Efficiency Particulate Air
•HLD = High Level Disinfectant
•Hr. = Hour
•Hz = Hertz
•I/O = Input/ Output
•IEC = International Electrotechnical Commission
•LED = Light Emitting Diode
•MEC = Minimum Effective Concentration
•MRC = Minimum Recommended Concentration
•NIST=National Institute of Standards and Technology
•OEM = Original Equipment Manufacturer
•P/N = Part Number
•PDF= Portable Document Format
•PM = Preventative Maintenance
•PPE = Personal Protective Equipment
•PSI = Pounds Per Square Inch
•TCIM = Thermal couple Input Module
•UDI = Unique Device Identification
•USB = Universal Serial Bus
•V = Volts

System 83 Plus™ Washer/Disinfector
Service Manual
MAN–202 Revision 03082022 Page 6 of 54
Warning and Caution Statements
A WARNING indicates a potentially hazardous situation which, if not avoided, could result in an improperly
reprocessed endoscope and/or death or serious injury to an operator.
A CAUTION indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury
to an operator. It may also be used to alert against unsafe practices or potential equipment damage.
WARNING: The duodenoscopes that are validated for reprocessing in the System 83 Plus™ are the Olympus
TJF-Q180V and the Pentax ED-3490TK using ortho‐Phthalaldehyde Solution high‐level disinfectant
(OPA) for a minimum of 12 minutes at 20°C. The System 83 Plus™ is not validated for the
reprocessing of the FUJIFILM duodenoscopes and of duodenoscopes with open elevator wire
channels.
WARNING: Use of HLDs other than OPA have not been validated in the System 83 Plus™ and are not
recommended for use by Custom Ultrasonics.
WARNING: Manual Pre-Processing of endoscope(s) is important and must be completed prior to placing
endoscopes into the processing chamber of the System 83 Plus™. Failure to perform proper
pre-cleaning or failure to follow applicable endoscope manufacturers labeling requirements for
reprocessing may result in an endoscope that has not been properly reprocessed.
WARNING: If the pressure differential of the water inlet filter system exceeds 25 psi, stop using the System 83
Plus™. Replace the filters immediately as post filter water supply quality cannot be assured if the
pressure differential is exceeded. Final rinse water quality cannot be assured if the 25 psi pressure
differentials are exceeded.
WARNING: Rapid change over from air to water (Water Hammer Effect) can result in water filter damage.
WARNING: Not following the filter maintenance requirements in this manual may result in inadequate reprocessing.
WARNING: In the event that flow is restricted in a flushing adapter featuring an in-line disc filter, the operator is
instructed to replace the in-line 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 System 83 Plus™ and
call Custom Ultrasonics for service.
WARNING: Visually confirm flow through each of the flushing adapters of the System 83 Plus™ at the beginning
and end of a process and during an air/alcohol purge. If no flow is observed through the adapter, stop
using the System 83 Plus™ and call Custom Ultrasonics for service.
WARNING: The System 83 Plus™ must be operated by trained personnel with the necessary understanding in the
operations of the System 83 Plus™, and the requirements for the reprocessing of endoscope(s).
WARNING: Failure to utilize the correct endoscope flushing adapters or correct configuration may result in an
endoscope(s) that has not been properly high-level disinfected.
WARNING: When operating automatic door (lid), do not place face or body in the way of the motion of the door,
injury may occur.
WARNING: The System 83 Plus™ must not be located next to or near an X-Ray, CAT scan or MRI equipment.
WARNING: The System 83 Plus™ equipment is not suitable for use in the presence of flammable mixtures with air
or with oxygen or nitrous oxide.
WARNING: Failure to submerse the endoscope in the correct detergent solution and HLD products for the
recommended time, temperature and MEC may result in ineffective reprocessing.
WARNING: The (F7) WASH ONLY cycle will wash and rinse 1 or 2 endoscopes per bay, but does not high-level
disinfect the endoscope(s). This wash only cycle should not be used as a terminal process prior to
patient use.

System 83 Plus™ Washer/Disinfector
Service Manual
MAN–202 Revision 03082022 Page 7 of 54
WARNING: When alcohol purging an endoscope with an elevator, make sure the forceps elevator is in the half-up
half-down position. Follow the endoscope manufacturer’s instructions for flushing alcohol into and
around the forceps elevator recess at the distal tip. Endoscope manufacturer may require forceps
elevator deflection during this step.
CAUTION: The System 83 Plus™ is equipped with a circuit breaker switch that is located on the right hand side if
facing the device. Do not place the breaker in the off position, without first properly shutting down the
computer system to avoid possibly corrupting the system software. The circuit breaker switch is for
system protection, emergency shut down, and service technician use only.
CAUTION: GFCI receptacle(s) are not recommended since the System 83 Plus™ contains an electrostatic
isolation transformer that reduces leakage to ground and may trip the hospital breaker, the System 83
Plus’™ breaker or both.
CAUTION: Do not connect or operate System 83 Plus™ using an emergency generator outlet because it may
create current surges that may damage computer components.
CAUTION: The operator must perform daily checks of all in-line disc filters for all flushing adapters to the
endoscopes. Replace as required or every six (6) weeks and document the in-line disc filter change
date on the Filter and Gauge Log sheet.
CAUTION: Tergal 800®is a detergent; it is NOT a High-Level Disinfectant.
CAUTION: Only Custom Ultrasonics filters, adapters, accessories, and associated components have been
validated in the System 83 Plus™; therefore, when replacing these parts, use only OEM parts.
CAUTION: Check HLD level in disinfectant reservoir on a per cycle basis, as prompted on the display before
performing a Wash/Disinfection cycle. Be alert to any unusual or significant loss of HLD. Be certain
to confirm HLD’s MEC according to manufacturer’s labeling requirements.
CAUTION: Operator of device should refer to the HLD and Detergent handling and use requirements when
operating the device and for addressing spills. (Refer to the product material Safety Data Sheet)
CAUTION: The System 83 Plus™ must not be connected to the facilities network.
CAUTION: System 83 Plus™ software updates must be authorized and performed by Custom Ultrasonics.
CAUTION: Always refer to Scope Diagrams and Scope Adaptation Charts for all endoscopes when selecting
flushing adapters for endoscope models as adaptation will differ between endoscope models.
Endoscope adaptation information can be located at: customultrasonics.com.
CAUTION: All System 83 Plus™ maintenance must be maintained according to Custom Ultrasonics labeling
instructions to maintain the integrity and safety of the System 83 Plus™. Not following all scheduled
Custom Ultrasonics maintenance in this manual may result in damage or unsafe operating conditions
of the System 83 Plus™.
CAUTION: Endoscopes, including duodenoscopes, should be inspected before reprocessing in the System 83
Plus™ and maintained as per the endoscope manufacturer’s labeling requirements.
CAUTION: Do not place any objects other than flexible endoscopes and endoscope accessories into the
processing chamber of the System 83 Plus™.
CAUTION: Do not place anything on the System 83 Plus™ lids. Be certain that nothing can obstruct the lid from
closing (Example: endoscopes, valve cover, adapters etc.).
CAUTION: Follow all facility protocols for personal protective equipment requirements PPE, such as: Eye/Mask
Protection, Rubber Gloves, and Protective Gown.
CAUTION: Do not let the air pump remain operating while unattended.

System 83 Plus™ Washer/Disinfector
Service Manual
MAN–202 Revision 03082022 Page 8 of 54
CAUTION: Do not neutralize the HLD in the System 83 Plus™. Please contact Custom Ultrasonics for an
alternative option.
CAUTION: Keep the System 83 Plus™ locked, the operator should not have access to the inside of the System
83 Plus™. Store the key with a manager.
CAUTION: Shutting down the System 83 Plus™ in a manner other than the (F3) Shutdown process may cause
damage to the computer system.
Labels and Label Indication
Label
Indication
Duodenoscopes validated for reprocessing in the
System 83 Plus™: Olympus TJF-Q180V and Pentax
Model ED-3490TK.
Duodenoscopes NOT validated for reprocessing in
the System 83 Plus™: Duodenoscopes with an
open elevator wire channel and all Fujifilm
Duodenoscopes
WARNING: When operating automatic door (lid), do
not place face or body in the way of the motion of
the door, injury may occur.
FRENCH VERSION
FRENCH VERSION
WARNING: When removing the rear panel door,
hold the door by the handle to prevent it from falling.
FRENCH VERSION
WARNING: Potential hazard.
WARNING: Potential Electrical Shock Hazard.
Disconnect device from electrical power source
before removing cover and servicing.

System 83 Plus™ Washer/Disinfector
Service Manual
MAN–202 Revision 03082022 Page 9 of 54
Indication
CAUTION: Ground reliability can only be achieved
when the device is connected to an equivalent
receptacle marked hospital grade.
Graphical Symbol: Indicates protective earth
ground.
Graphical Symbol: Indicates an earth ground.
Graphical Label: Indicates electrical rating of the
System 83 Plus™
Graphical Label: Indicates avoid contact of plug
pins.
Graphical Label: Indicates the device has been
tested and conforms to UL STD 60601-1 Certified to
CAN/CSASTD C22.2 NO.601.1
Graphical Label: Indicates the thermocouple plug
connection for the reservoir chamber
Graphical Label: Indicates the thermocouple plug
connection for the processing chamber
Graphical Label: Indicates the ON/OFF position of
the circuit breaker on the side of the System 83
Plus™
Graphical Label: Indicates the location of bay 1
Graphical Label: Indicates the location of bay 2
(if applicable)
Graphical Label: Indicates bay 1 power cord
Graphical Label: Indicates bay 2 power cord
(if applicable)
Graphical Label: Indicates bay 1 foot pedal
connection
Graphical Label: Indicates bay 2 foot pedal
connection (if applicable)

System 83 Plus™ Washer/Disinfector
Service Manual
MAN–202 Revision 03082022 Page 10 of 54
Label
Indication
Graphical Label: Indicates the air switch on the
front door
Graphical Label: Indicates the rinse switch on the
front door
Graphical Label: Indicates the high pressure
channel monitoring override switch on the front door
Graphical Label: Indicates the flow sensor indicator
box
Graphical Label: Indicates the flow sensors for
ports 1 to 8
Graphical Label: Indicates the flow sensors for
ports 9 and 10
UDI Device Label: Indicates the device and
production information that corresponds to the
specific device through plain-text and barcode
formats. This label is applied directly to the device.
UDI Shipping Label: Indicates the device and
production information that corresponds to the
specific device through plain-text and barcode
formats. This label is applied to device packaging.
Shipping and Handling Limitations Label:
Indicates the shipping and handling conditions for
the System 83 Plus™.