CUSTOM ULTRASONICS 83 Plus System 2 User manual
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
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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
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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
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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
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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.
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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.
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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.
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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)
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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™.
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System 83 Plus™ Washer/Disinfector
Service Manual for Models:
System 83 Plus™ 2
System 83 Plus™ 9
This manual is to be used with the System 83 Plus™ 2 and System 83 Plus™ 9 Washer/Disinfectors that are labeled
and distributed exclusively by Custom Ultrasonics, Inc.
Introduction
The System 83 Plus™ Washer/Disinfector is intended for the cleaning and high-level disinfection of one or two
submersible flexible endoscopes (per bay) that feature several internal channels that do not contact normally sterile
areas of the body i.e., semi-critical devices. The types of flexible endoscopes for which this System 83 Plus™
Washer/Disinfector is labeled to reprocess include those that are used to examine, diagnose and treat diseases of
the upper and lower gastrointestinal tract and pulmonary tracts. Examples include flexible colonoscopes,
gastroscopes, bronchoscopes and specific duodenoscopes.
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.
Indication for use
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
pre-cleaned and manually cleaned, and then exposed to the washing /disinfection cycle of the System 83 Plus™,
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.
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Detergents
Tergal 800®Detergent is validated for use in the System 83 Plus™. The automatic injection of Tergal 800®Detergent
is pre-set by Custom Ultrasonics.
CAUTION: Tergal 800®is a detergent; it is NOT a High-Level Disinfectant.
High Level Disinfectant (HLD)
Ortho-Phthalaldehyde Solution high-level disinfectant (OPA) is validated for use in the System 83 Plus™ with a
nominal active ingredient composition of 0.55%, having a Minimum Recommended Concentration (MRC) of 0.3%,
minimum contact condition of 12 minutes at 20°C, and a re-use period not to exceed 14 days. The immersion time
and temperature for the HLD is pre-set by Custom Ultrasonics.
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.
Electrical Safety
The System 83 Plus™ complies with IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for
Basic Safety and Essential Performance and IEC 60601-1-2 General Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility.
Electrical Rating
System Electrical: 110 VAC, 10 AMP, 60 Hz (per bay).
Physical Description of System 83 Plus™
•Dimensions
System 83 Plus™ 2: 62” (H) x 34” (W) x 34” (D)
System 83 Plus™ 9: 62” (H) x 68” (W) x 34” (D)
•Weight
System 83 Plus™ 2: 350 lbs. (Approximate Dry Weight)
System 83 Plus™ 9: 700 lbs. (Approximate Dry Weight)
•Heat Load
System 83 Plus™ 2: ~3583 BTU / Hr.
System 83 Plus™ 9: ~6142 BTU / Hr.
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Site Requirements
Refer to and follow all local, state and federal electrical and plumbing code requirements in your area.
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.
Electrical Requirements
The System 83 Plus™ requires one dedicated 120 VAC (±10%), 20 AMP, 60 Hz, Single Phase, NEMA 5-15R
receptacle located within the operator’s reach.
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.
Water Requirements
•The potable tap water plumbing supply line(s) to be provided by the facility for the System 83 Plus™ must
be ½” or ¾” supply line(s) with a reduced pressure backflow preventer and shut off valves terminating in ¾”
male garden hose connections
•Water pressure between 55 and 70 psi (pounds per square inch)
•Maximum flow rate of 6.0 gpm (gallons per minute)
•Water temperature of 110°F (±5°F)
•Water hardness less than 12 gpg (grains per gallon) or 200 ppm (parts per million)
NOTE: It is recommended that the facility water be analyzed to determine if the facility water is potable.
Reverse osmosis and deionized water should not be used in the System 83 Plus™.
Waste Drain Requirements
The System 83 Plus™ requires a minimum 2” in diameter vented standpipe with a height of 18” above floor level that
is capable of draining a minimum of 4.5 gpm (gallons per minute) per bay is required for the System 83 Plus™.
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Installation Requirements
The System 83 Plus™ should be inspected prior to installation for damage. The healthcare facility should move the
System 83 Plus™ and associated components to a secure area until installation occurs.
In-Service Training Requirements
Following delivery of a new System 83 Plus™, the medical facility must schedule a date for the training of Operating
and Bio-Medical personnel by a Custom Ultrasonics technician. During the in-service training, personnel will be
instructed on the proper operation of the System 83 Plus™ and the identification and use of endoscope adapters on
the individual flexible endoscope models in inventory at the time of the in-service. At the conclusion of this training,
all personnel in attendance are required to sign off on in-service documentation that they have been trained on how
to properly adapt each endoscope model identified in their facility inventory, as well as additional procedures and
information reviewed during the training presentation. For personnel assigned the responsibility for reprocessing
flexible endoscopes, attendance will assure all sections of the training program are reviewed and the handouts, charts
and instructions are understood and retained for reference.
A preventative maintenance and service training is provided for maintenance and/or biomedical/maintenance
personnel at the time of in-service. At the conclusion of this training, all personnel in attendance are required to sign
off on In-Service documentation that they have been trained on how to properly maintain and repair the System 83
Plus™.
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).
Service Personnel Qualifications
Custom Ultrasonics technicians, Authorized Service Providers, and Biomedical personnel that are appropriately
trained by Custom Ultrasonics are recommended to perform service on the System 83 Plus™. These personnel
receive product specific training on service and are best equipped to assure the device performs as intended.
Thoroughly review the following before use:
•Read the Operator’s Manual before use of the System 83 Plus™.
•Proper handling of endoscopic equipment.
•Professional health and safety standards.
•Proper use of personal protective equipment (PPE).
Preventative Maintenance Requirements
It is imperative that proper preventative maintenance guidelines are strictly followed in accordance with Custom
Ultrasonics preventative maintenance instructions to ensure the proper operation of the System 83 Plus™. Please
contact Custom Ultrasonics for a list of Authorized Service Providers (ASP) in your area.
Warranty Requirements
Warranty period is one (1) year from the date of installation of the System 83 Plus™ or fifteen (15) months from the
date of shipment. Failure to meet all requirements could void the manufacturer warranty. Damage caused by facilities
personnel or utilities will not be covered.
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Navigating the Software Program
This section will go over navigating the software for service and support use. It will instruct on the use of the service
screen, how to look up errors in the reports area, and complete wash/disinfect cycles to test after a preventative
maintenance is performed.
Logging In
1. Once the system is turned on, the first screen that will appear is the login screen.
2. Login using an administrative username and password. A username and password should have been issued
during installation. Contact the department administrator to obtain a unique username and password.
Illustration: Login Screen
Main Menu Screen
The first screen after sign in will be the main menu screen, consisting of (7) options. These options are:
•CU System
•(F8) Log off
•Reports
•(F6) Night Mode
•Database Entry
•(F3) Shutdown
•Service Screen
Illustration: Main Menu Screen (7 Options)
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Reports Screen
Reports allows lookup of Purge Log, Backup Log, Shutdown Log and Process Information. Enter the Process
Information screen to review system errors.
CAUTION: The System 83 Plus™ must not be connected to the facilities network.
NOTE: The facility should have some form of back up, e.g. paper printout or USB drive.
NOTE: Only use freshly formatted USB drives that are formatted on a known safe and secure facility computer
to back up the database and to export reports.
Process Info Screen
Process Information will be the area that allows lookup of errors and cycles performed on based on date range. To
look up the error from the main menu screen:
1. Press (R) to enter Reports. Press (I) to enter Process Info. See the illustration below
2. To delete the existing date in the From box use the (BACKSPACE) key.
3. Type in the new From date in the From box and press (TAB).
4. To delete the existing date in the To box use the (BACKSPACE) key.
5. Type the new To date in the To box and press (TAB), arrow down to highlight the bay to apply the search to,
press (TAB), arrow down and highlight desired type of search then press (TAB).
6. Optionally you can also filter the search by instrument or physician, highlight appropriate search box and arrow
down to select the instrument or physician.
7. Once all search parameters are entered press (F1) Get Data to execute the search.
8. Press (F5) to print all the information. Press (F10) to access the data grid and use the arrow keys to highlight
and press (F7) to print the selected report. Press (F2) to restart another search. Press (F8) to close.
Illustration: Process Info Screen
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Service Screen
The service screen will be the used when testing and troubleshooting the System 83 Plus™. In the service screen,
the option is available to test the components, sensors, and printer.
CAUTION: Safety Floats will not prevent overflowing while testing functions in the Service Screen.
To enter the service screen from the main menu screen press (S) or use the arrow keys to highlight the
(Service Screen) icon on the screen and press (Enter).
The service screen allows the user to activate each component or combination of components. A second column
will be seen on the service screen for System 83 Plus™ 9 devices.To activate a component, use the up and down
arrow keys to highlight the component and based on the bay in which the component is located, press (1) for bay 1
or (2) for bay 2, the corresponding indicator will illuminate and the component will activate. Deactivate the component,
using the same number key. To exit the service screen, press (F8) to return to the main menu screen.
Illustration: Service Screen
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Quarterly Preventative Maintenance
The preventative maintenance must be performed and begins with an overall visual assessment of the System 83
Plus™ (Refer to: Preventative Maintenance Schedule Checklist). Preventative maintenance inspection and checks
that identify potential failures must be documented and repaired accordingly.
External Inspection of the System 83 Plus™
Perform visual inspection of the following items. As necessary, clean, and document replacement or repair of parts
during the preventative maintenance.
1. Inspect chassis for cleanliness
•Check for overall cleanliness of the system and visible external components.
2. Check all Warnings / Indicator labels
•Labels present on the system exterior are legible.
3. Inspect power cords
•Ensure properly connected to AC outlet. Inspect for wear and damage.
4. Inspect the power lid(s) and foot pedal(s)
•All lids are properly resting on the seal.
•Check for cracks or broken lids or hinges.
•Check hinges for wear and tear.
•Check foot pedal and cable for wear and damage.
5. Inspect the water fill and drain hoses
•Hoses secure. Inspect for cracking and leaks.
6. Inspect the detergent bottle, tubing, and fittings
•Check bottle level; replace as necessary. Check tubing for kinks and damage. Check fittings for
leaks.
7. Inspect the water filter housings and gauges
•Inspect housing for leaks, gauges for damage.
8. Inspect the keyboard, computer, and printer
•Inspect keyboard cover for puncture, tears and wear.
•Inspect the keyboard for damage and that it is properly connected to the computer.
•Inspect the computer for damage to the display and that all connections are secure.
•Check the printer is present and connected to the computer.
Process Info Log Review
After the visual inspection, review the error log from the date of the last preventative maintenance. Refer to the
Navigating the Software Program section for instructions on how to review the logs.
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Service Screen Component Testing
The following is an overview of components to be inspected during the preventative maintenance.These components
can be activated from the service screen. Refer to the Navigating the Software Program section for instructions on
how to use the service screen.
Water Solenoid
CAUTION: Safety Floats will not prevent overflowing while testing functions in the Service Screen.
1. Activate the Water valve in the service screen.
2. Verify the Water valve output indicator illuminates on the left side of the service screen.
3. Verify the Flow input indicator illuminates on the right side of the service screen.
4. Listen for a click when activated.Water should come into the processing chamber once opened and the
Flow input indicator on the screen should illuminate.
Ultrasonics
CAUTION: The ultrasonics should not be activated without water in the processing chamber.
1. Fill the processing chamber with water up to the specialty channel flushing ports.
2. Activate the Ultrasonics in the service screen.
3. Verify the Ultrasonicsoutput indicator illuminates on the left side of the service screen.
4. Verify the Ultrasonicsinput indicator illuminates on the right side of the service screen.
Drain/HLD Return Pump
1. Activate the Drain pump.
2. Verify the Drain pump output indicator illuminates on the left side of the service screen.
3. Listen for the pump when activated.If the pump is not activated or atypically loud, this may require further
action to either clean, remove debris, or replace components.
Drain Solenoid
1. Activate the Drain valve.
2. Verify the Drain valve output indicator illuminates on the left side of the service screen.
3. Listen for a click when activated.
Purge Pump
1. Activate the Purge pump.
2. Verify the Purge pump output indicator illuminates on the left side of the service screen.
3. Listen for the pump when activated. If the pump is not activated or atypically loud, the pump may need to be
replaced.
HLD Feed Pump
1. Activate the Reservoir pump.
2. Verify the Reservoir pump output indicator illuminates on the left side of the service screen.
3. Listen for the pump when activated.If the pump is not activated or atypically loud, this may require further
action to either clean, remove debris, or replace components.
HLD Feed Solenoid
1. Activate the Reservoir feed.
2. Verify the Reservoir feed output indicator illuminates on the left side of the service screen.
3. Listen for a click when activated.
HLD Return Solenoid
1. Activate the Reservoir return.
2. Verify the Reservoir return output indicator illuminates on the left side of the service screen.
3. Listen for a click when activated.
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Residual Drain Pump and Solenoid
1. Activate the Residual drain.
2. Verify the Residual drain output indicator illuminates on the left side of the service screen.
3. Listen for the pump and the click of the solenoid when activated. If the pump is not activated or atypically
loud, the pump may need to be replaced.
Air Pump and Solenoid
1. Activate the Air.
2. Verify the Air output indicator illuminates on the left side of the service screen.
3. Listen for the pump and the click of the solenoid when activated. If the pump is not activated or atypically
loud, the pump may need to be replaced.
Detergent Pump and Solenoid
1. Activate the Lubrication (83 det).
2. Verify the Lubrication (83 det)output indicator illuminates on the left side of the service screen.
3. Listen for the pump and the click of the solenoid when activated. If the pump is not activated or atypically
loud, the pump may need to be replaced.
4. Check for incoming detergent at the inlet baffle in the processing chamber to confirm the pump is working.
5. Inspect detergent tubing for air pockets and with the pump activated, depress the detergent hand pump as
necessary to remove the air pockets.
Disinfectant Reservoir Heat Pad
NOTE: The heater float in the disinfectant reservoir must be in the up position to test the reservoir heat function.
1. Activate the Reservoir heat.
2. Verify the Reservoir heat output indicator illuminates on the left side of the service screen.
3. Check for heat from the heat pad under the disinfectant reservoir.
Processing Chamber Heat Pad
1. Activate the Bay heat.
2. Verify the Bay heat output indicator illuminates on the left side of the service screen.
3. Check for heat from the heat pad around the processing chamber.
Service Screen Input Sensor Testing
A float is activated by liquid reaching a specified level in the processing chamber and/or the disinfectant reservoir. A
corresponding indicator in the CU software will indicate that the float is activated. To test a float, activate it manually
or by filling the chamber(s) with liquid. When the float has been activated, the indicator next to the float label on the
service screen under the corresponding bay will illuminate. To deactivate the float, either manually release the float
or remove liquid from the chamber(s). Below are the sensors in the service screen that are checked during this
testing:
Flow Sensor
1. The Flow input indicator was tested in the Water Solenoid section.
2. Verify that the Flow input indicator illuminates on the right side of the service screen.
Float Sensor
1. Manually lift the lower float in the processing chamber.
2. Verify the Float input indicator illuminates on the right side of the service screen.
Safety Float Sensor
1. Manually lift the upper float in the processing chamber.
2. Verify the Safety input indicator illuminates on the right side of the service screen.
3. Manually lift the upper float in the disinfectant reservoir.
4. Verify the Safety input indicator illuminates on the right side of the service screen.
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