CUSTOM ULTRASONICS 83 Plus System 2 Service Manual
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CUSTOM ULTRASONICS 83 Plus System 2 Service Manual

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

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Summary of Contents for CUSTOM ULTRASONICS 83 Plus System 2

  • Page 1 Custom Ultrasonics, Inc. System 83 Plus™ Washer/Disinfector Service Manual Custom Ultrasonics, Inc. 144 Railroad Drive Ivyland, PA 18974 215-364-1477 customultrasonics.com MAN-202 Revision 03082022 P/N 13167...

  • Page 2: Table Of Contents

    System 83 Plus™ Washer/Disinfector Service Manual 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) ........................
  • Page 3 System 83 Plus™ Washer/Disinfector Service Manual 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 ............................
  • Page 4 System 83 Plus™ Washer/Disinfector Service Manual 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.......................

  • Page 5: Abbreviations, Warnings, And Cautions

    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 ±...

  • Page 6: Warning And Caution Statements

    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™...
  • Page 7 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™.

  • Page 8: Labels And Label Indication

    System 83 Plus™ Washer/Disinfector Service Manual 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™.
  • Page 9 System 83 Plus™ Washer/Disinfector Service Manual 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™...
  • Page 10 System 83 Plus™ Washer/Disinfector Service Manual 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 Graphical Label: Indicates the flow sensors for ports 1 to 8...

  • Page 11: Introduction

    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.

  • Page 12: Detergents

    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™...

  • Page 13: Site Requirements

    System 83 Plus™ Washer/Disinfector Service Manual 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™...

  • Page 14: Installation Requirements

    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.

  • Page 15: Navigating The Software Program

    System 83 Plus™ Washer/Disinfector Service Manual 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.

  • Page 16: Reports Screen

    System 83 Plus™ Washer/Disinfector Service Manual 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.

  • Page 17: Service Screen

    System 83 Plus™ Washer/Disinfector Service Manual 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).

  • Page 18: Quarterly Preventative Maintenance

    System 83 Plus™ Washer/Disinfector Service Manual 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™...

  • Page 19: Service Screen Component Testing

    System 83 Plus™ Washer/Disinfector Service Manual 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.

  • Page 20: Residual Drain Pump And Solenoid

    System 83 Plus™ Washer/Disinfector Service Manual 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.

  • Page 21: Ultrasonics Sensor

    System 83 Plus™ Washer/Disinfector Service Manual Ultrasonics Sensor 1. The Ultrasonics input indicator was tested in the Ultrasonics section testing. 2. Verify that the Ultrasonics input indicator illuminates on the right side of the service screen. Water Channel Sensor 1. The Water channel pressure input indicator will be tested later in the Water Channel Testing section. 2.

  • Page 22: Ventilation Sensors

    System 83 Plus™ Washer/Disinfector Service Manual Ventilation Sensors Optic sensors are located in the processing chamber in the float compartment and inside the disinfectant reservoir near the top of the back wall of the chamber. Refer to Illustration: Vent Intake and Vent Optic Sensor. 1.

  • Page 23: Filter Screen Inspection

    System 83 Plus™ Washer/Disinfector Service Manual Filter Screen Inspection 1. Located in the processing chamber, is a side compartment covered by a perforated cover. 2. Remove the cover and locate the housing containing the intake filter screen. 3. If lint is found, unscrew the housing and remove and thoroughly clean the intake filter screen under running water with a stiff bristle brush.

  • Page 24: High Pressure Channel Monitoring Override Switch

    System 83 Plus™ Washer/Disinfector Service Manual High Pressure Channel Monitoring Override Switch 1. Activate the High Pressure Channel Monitoring Override Switch. Visually observe the LED light blinking. Illustration: Override switch and LED illuminated Power Lid and Foot Pedal Switches WARNING: When operating automatic door (lid), do not place face or body in the way of the motion of the door, injury may occur.

  • Page 25: Adapter Inspection

    System 83 Plus™ Washer/Disinfector Service Manual Adapter Inspection 1. Prior to use, inspect all endoscope flushing adapters for tears, breaks, or damage before connecting to an endoscope to be reprocessed. If any tears, breaks, or damage to the adapters is observed upon inspection, replace immediately.

  • Page 26: Printer Testing

    The following filters need to be replaced at every preventative maintenance. 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. 100 Micron Capsule Filter Refer to the 100 Micron Capsule Filter Replacement (P/N 11087) section under Part Replacement Instructions for replacement instructions.

  • Page 27: Disinfection Procedure For The Alcohol Line And Detergent Line

    System 83 Plus™ Washer/Disinfector Service Manual Disinfection Procedure for the Alcohol Line and Detergent Line Perform the following procedure for disinfection of the alcohol and detergent line. Connect the system to AC power and power on the system. The following steps will be performed in the service screen. Fresh ortho-Phthalaldehyde Solution with a nominal active ingredient composition of 0.55% should be used for each disinfection procedure and the OPA solution should not be reused.

  • Page 28: Biannual Preventative Maintenance

    The following components need to be replaced at every annual preventative maintenance. 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. Processing Chamber Bulkheads Refer to the Female Adapter Ports Replacement (P/N 18022) section under Part Replacement Instructions for replacement instructions.

  • Page 29: Water Inlet Filtration System

    System 83 Plus™ Washer/Disinfector Service Manual Water Inlet Filtration System 25 and 5 Micron Filter Replacement Procedure Replacement procedure for the 25 and 5 micron filters. Locate the water filtration system. 15 PSI 15 PSI 25 PSI DIFFERENTIAL DIFFERENTIAL DIFFERENTIAL GAUGE 3 GAUGE 2 GAUGE 4...

  • Page 30: 0.1 Micron Filter Replacement And Disinfection Procedure

    System 83 Plus™ Washer/Disinfector Service Manual 0.1 Micron Filter Replacement and Disinfection Procedure Disinfection and replacement procedures for the water inlet filters and the inlet plumbing lines. The following steps must be performed whenever changing the 0.1 micron filter. Required Tools Filter Wrench (P/N 13045) •...
  • Page 31 System 83 Plus™ Washer/Disinfector Service Manual 25. Press the rinse switch(es) on the front door. Activate the hand sprayer(s) directing the flow into the processing chamber(s) and rinse the hand sprayer hose(s) with copious amounts of fresh water. 26. Complete the applicable information in the Filter and Gauge Log after the water filters have been replaced. 27.

  • Page 32: Cables And Connections

    System 83 Plus™ Washer/Disinfector Service Manual Cables and Connections The System 83 Plus™ consists of electrical components. These components require their electrical lines be properly oriented and connected throughout the chassis. Placement of each of the following cables in their appropriate ports is important for proper function of the System 83 Plus™.

  • Page 33: Post-Preventative Maintenance Testing

    System 83 Plus™ Washer/Disinfector Service Manual Post-Preventative Maintenance Testing 1. Ensure the System 83 Plus™ is connected to power and the circuit breaker is on. 2. Press the power button on the computer to power up the system. 3. Allow the system to complete the power up process and login to the system using an administrator username and password.

  • Page 34: Part Replacement Instructions

    System 83 Plus™ Washer/Disinfector Service Manual Part Replacement Instructions Once it has been determined that part(s) need to be replaced, the System 83 Plus™ should be powered off. When conducting any of the following repairs: 1. Power off the computer and then place the system circuit breaker in the off position. 2.
  • Page 35 System 83 Plus™ Washer/Disinfector Service Manual O-Ring Swollen Ensure there are no physical indentations or cuts where the diaphragm meets the valve body orifice. Worn There is a tiny bleeder hole located on each Diaphragm Diaphragm diaphragm. Ensure it is free of build up or debris. Mineral build up Mineral build up may cause diaphragms to not properly seal or close.

  • Page 36: Solenoid Valve Replacement

    Level Disinfect Return, Drain, Residual Drain and Water Inlet. All solenoid valves in both models of the System 83 Plus™ are normally closed and open upon energizing. The following instructions will describe how to replace the inner diaphragms of each of the aforementioned valves. The Custom Ultrasonics part number for each valve is as follows:...

  • Page 37: Detergent Solenoid Rebuild Kit Replacement (P/N 6-606R)

    System 83 Plus™ Washer/Disinfector Service Manual Detergent Solenoid Rebuild Kit Replacement (P/N 6-606R) WARNING: The System 83 Plus™ should be powered off when inspecting or replacing components to prevent electrical shock and damage to the device. CAUTION: Detergent bottle should be placed on the floor when replacing the detergent valve rebuild to avoid syphoning.

  • Page 38: Hld Feed And Hld Return/Drain Solenoid Rebuild Kit Replacement (P/N 12-606R)

    System 83 Plus™ Washer/Disinfector Service Manual HLD Feed and HLD Return/Drain Solenoid Rebuild Kit Replacement (P/N 12-606R) WARNING: The System 83 Plus™ should be powered off when inspecting or replacing components to prevent electrical shock and damage to the device. CAUTION: Have all liquid fully drained from the System 83 Plus™...

  • Page 39: Residual Drain Solenoid Rebuild Kit Replacement (P/N 623-606R)

    System 83 Plus™ Washer/Disinfector Service Manual Residual Drain Solenoid Rebuild Kit Replacement (P/N 623-606R) WARNING: The System 83 Plus™ should be powered off when inspecting or replacing components to prevent electrical shock and damage to the device. CAUTION: Have all liquid fully drained from the System 83 Plus™ prior to conducting any maintenance to avoid residual liquid in plumbing spilling out.

  • Page 40: 100 Micron Capsule Filter Replacement (P/N 11087)

    System 83 Plus™ Washer/Disinfector Service Manual 100 Micron Capsule Filter Replacement (P/N 11087) WARNING: The System 83 Plus™ should be powered off when inspecting or replacing components to prevent electrical shock and damage to the device. 1. A towel should be placed beneath the 100 micron capsule filter when conducting filter replacement to collect any residual liquid left in the plumbing lines.

  • Page 41: Charcoal Filter Replacement (P/N 21017)

    System 83 Plus™ Washer/Disinfector Service Manual Charcoal Filter Replacement (P/N 21017) WARNING: The System 83 Plus™ should be powered off when inspecting or replacing components to prevent electrical shock and damage to the device. 1. Using a filter wrench, loosen the (blue) backpack filter canister. 2.

  • Page 42: Hld Feed Pump Impeller (P/N 11009) And Pump Shaft (P/N 11135) Replacement

    System 83 Plus™ Washer/Disinfector Service Manual New impeller (P/N 11009) Damaged impeller HLD Feed Pump Impeller (P/N 11009) and Pump Shaft (P/N 11135) Replacement Bolt Location WARNING: The System 83 Plus™ should be powered off when inspecting or replacing components to prevent electrical shock and damage to the device.

  • Page 43: Flow Probe Replacement (P/N 12002)

    System 83 Plus™ Washer/Disinfector Service Manual Flow Probe Replacement (P/N 12002) WARNING: The System 83 Plus™ should be powered off when inspecting or replacing components to prevent electrical shock and damage to the device. 1. The Flow Probe needs to be removed and cleaned to remove buildup. 2.

  • Page 44: Air Pump Intake Filter Replacement (P/N 20010)

    System 83 Plus™ Washer/Disinfector Service Manual Air Pump Intake Filter Replacement (P/N 20010) WARNING: The System 83 Plus™ should be powered off when inspecting or replacing components to prevent electrical shock and damage to the device. 1. Remove the black air pump intake filter by unscrewing the filter from the pump assembly. 2.

  • Page 45: Ultrasonic Generator (P/N 12008) And Signal Circuit Board (P/N 12073) Replacement

    System 83 Plus™ Washer/Disinfector Service Manual Ultrasonic Generator (P/N 12008) and Signal Circuit Board (P/N 12073) Replacement WARNING: The System 83 Plus™ should be powered off when inspecting or replacing components to prevent electrical shock and damage to the device. CAUTION: Proper ESD (Electro Static Discharge) protection should be utilized when conducting this repair.
  • Page 46 System 83 Plus™ Washer/Disinfector Service Manual Electrical Immunity and Compliance Testing Standard Edition CISPR11, +A1:2004 2003 CAN/CSA C22.2 No 601.1-M90 (Medical 1990 Electrical Equipment, Part 1: General Requirements for Safety) UL 60601-1 (Medical Electrical Equipment, 2003 Part 1: General Requirements for Safety) IEC 60601-1-2, +A1:2004 2001 (Radiated and AC Line-Conducted...
  • Page 47 System 83 Plus™ Washer/Disinfector Service Manual Attachment MAN–202 Revision 03082022 Page 47 of 54...

  • Page 48: Attachment A Page 1 Of 6

    System 83 Plus™ Washer/Disinfector Service Manual Preventative Maintenance Schedule Checklist Quarterly Maintenance Person Performing PM Print Name: System Type: 83 Plus 2 (Bay 1) 83 Plus 9 (Bay 1, Bay 2) Device S/N: External Inspection of the System 83 Plus Bay 1 Bay 2 External Inspection...
  • Page 49 System 83 Plus™ Washer/Disinfector Service Manual System Type: 83 Plus 2 (Bay 1) 83 Plus 9 (Bay 1, Bay 2) Device S/N: Service Screen Component Testing (continued) Component Check Bay 1 Bay 2 Activated and Tested (Check in Service Screen) Activated the Drain valve.
  • Page 50 System 83 Plus™ Washer/Disinfector Service Manual System Type: 83 Plus 2 (Bay 1) 83 Plus 9 (Bay 1, Bay 2) Device S/N: Temperature Control Component Testing Bay 1 Bay 2 Component Check Activated and Tested Using the service screen, transfer the disinfectant from the disinfectant reservoir to the processing chamber until the level is below the heat float.
  • Page 51 System 83 Plus™ Washer/Disinfector Service Manual System Type: 83 Plus 2 (Bay 1) 83 Plus 9 (Bay 1, Bay 2) Device S/N: Function Testing Function Check Bay 1 Bay 2 Activated and Tested (Service Screen) • While the system was filling with water, checked the pressure differential between the Ultrasonics Testing and water filter gauges on the water filter system.
  • Page 52 System 83 Plus™ Washer/Disinfector Service Manual System Type: 83 Plus 2 (Bay 1) 83 Plus 9 (Bay 1, Bay 2) Device S/N: Internal Filters and Backpack Filter Filter Bay 1 Bay 2 Replaced (Only Use OEM Parts) 100 Micron Capsule Filter •...
  • Page 53 System 83 Plus™ Washer/Disinfector Service Manual System Type: 83 Plus 2 (Bay 1) 83 Plus 9 (Bay 1, Bay 2) Device S/N: Water Inlet Filtration System 25 and 5 Micron Filter Replacement Check Check and Replace Checked / Replaced (Only Use OEM Parts) 25 Micron Filter •...
  • Page 54 System 83 Plus™ Washer/Disinfector Service Manual This page left blank intentionally. MAN–202 Revision 03082022 Page 54 of 54...

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83 plus system 9

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