Steris InnoWave Unity Operator's Manual
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Steris InnoWave Unity Operator's Manual

Sonic irrigators
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InnoWave™ Unity and Unity 20 Sonic Irrigators
Operator Manual
ENGLISH

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  • Page 1 InnoWave™ Unity and Unity 20 Sonic Irrigators Operator Manual ENGLISH...
  • Page 3 LIMITED RIGHTS NOTICE TECHNICAL DOCUMENTATION/DATA: This technical manual shall not, without the written permission of STERIS be either (a) used, released, disclosed, or reproduced in whole or in part or (b) used in whole or in part for manufacture except that (i) such release, disclosure or use is necessary for emergency repair or overhaul;...
  • Page 4 Recommended Training moved to Safety Information. General Information updated. Specification moved to Chapter 9. Installation moved to DOC12354 "InnoWave Unity Installation and Commissioning Manual". Detail added to Loading of Instruments. Revised Symbols appearing during wash cycle. Maintenance moved to Chapter 5. Decontamination moved within Maintenance. Terms, Definitions, and Symbols added to Chapter 10.

  • Page 5: Table Of Contents

    InnoWave Unity & Unity 20 Operator Manual Table of Contents Safety Information 1.1 Safety Precautions 1.2 Personal Protective Equipment 1.3 Transportation and Storage 1.3.1 Lifting 1.3.2 Storage Markings 1.3.3 Environmental Conditions 1.4 Independent Monitoring 1.5 Recommended Operator Training General Information 2.1 Intended Purpose of Equipment...
  • Page 6 InnoWave Unity & Unity 20 Operator Manual 4.2 Recommended Chemicals — North America Only 4.3 Recommended Chemicals — Outside North America 4.4 Replacing the Chemical Bottle 4.5 Priming the Chemical Pump Using the Instrument Basket 5.1 The Instrument Basket 5.1.1 The Unity Instrument Basket 5.1.2 The Unity 20 Instrument Basket...
  • Page 7 InnoWave Unity & Unity 20 Operator Manual Maintenance 8.1 Important Safety Information 8.2 Daily Cleaning and Inspection 8.3 Weekly Cleaning and Inspection 8.4 Checking the Time and Date Settings 8.4.1 Time Setting Adjustment 8.4.2 Date Setting Adjustment 8.5 Performing a Full Decontamination 8.6 Accessories and Replacement Parts...
  • Page 8 InnoWave Unity & Unity 20 Operator Manual Wash Programs 12.1 Wash Program Configuration 12.2 Complete Wash Cycle Program 12.3 Soak Cycle Program 12.4 Open Programs 12.5 Decontamination Program Specification 13.1 Performance 13.2 Water Consumption - Unity 13.3 Water Consumption - Unity 20 13.4 Power Consumption...
  • Page 9 InnoWave Unity & Unity 20 Operator Manual Index TABLE OF CONTENTS...
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  • Page 11: Safety Information

    InnoWave Unity & Unity 20 Operator Manual HAPTER Safety Information This chapter contains important safety information about the equipment. Read this entire manual before attempting to install, operate, or perform any maintenance on the equipment. Make sure that all personnel understand the contents of this manual.

  • Page 12: Safety Precautions

    InnoWave Unity & Unity 20 Operator Manual Safety Precautions The following safety precautions must be observed when operating or servicing the equipment. WARNING indicates potential for personal injury. CAUTION indicates potential for damage to equipment. For emphasis, certain safety precautions are repeated throughout this manual. It is important to review ALL safety precautions before operating or servicing equipment.
  • Page 13 InnoWave Unity & Unity 20 Operator Manual WARNING — Electric shock hazard To avoid the risk of electric shock, this equipment must be connected to a mains supply with a protective earth. Dangerously high voltages are present inside the equipment.
  • Page 14 InnoWave Unity & Unity 20 Operator Manual WARNING — Burn hazard Since temperatures within the equipment can reach +60 °C (+140 °F) during and after operation, take care when opening the lid at the end of a wash cycle. Allow sufficient time for items to cool before handling, cleaning, or commencing maintenance procedures.
  • Page 15 InnoWave Unity & Unity 20 Operator Manual WARNING - No user-serviceable parts No user- serviceable parts inside the equipment. To avoid personal injury, improper equipment performance, invalidation of equipment warranty, or other costly damage, service and repair should only be performed by service technicians approved by the equipment manufacturer.
  • Page 16 InnoWave Unity & Unity 20 Operator Manual CAUTION— Equipment damage This equipment should not be used for any purpose other than that defined by the manufacturer as a sonic irrigator. Never place items or person(s) on the lid as this may result in damage to the equipment.

  • Page 17: Personal Protective Equipment

    InnoWave Unity & Unity 20 Operator Manual Personal Protective Equipment When operating or servicing this equipment, the following Personal Protective Equipment (PPE) must be worn: Goggles / safety glasses Protective gloves Protective clothing Boots with toe protection Transportation and Storage Make sure the package marking instructions and environmental conditions are always followed during the transportation and storage of the equipment.

  • Page 18: Environmental Conditions

    InnoWave Unity & Unity 20 Operator Manual 1.3.3 Environmental Conditions This equipment can be transported and stored safely in the following environmental conditions: Temperature range: +2 ºC to +60 ºC (+36 ºF to +140 ºF) Pressure range: 0.50 bar to 1.06 bar...

  • Page 19: Recommended Operator Training

    InnoWave Unity & Unity 20 Operator Manual Recommended Operator Training IMPORTANT The equipment owner has responsibility for training and keeping training records for all persons involved in operating and maintaining this equipment. Training should be regularly reviewed. It is recommended that operator training should cover, as a minimum, the following...
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  • Page 21: General Information

    InnoWave Unity & Unity 20 Operator Manual HAPTER General Information This chapter provides general information about the equipment. 2.1 Intended Purpose of Equipment 2.2 Equipment Features 2.3 Equipment Identification 2.4 Manufacturer Information 2.5 Applied Standards 2.6 Compliance 2.7 RoHS Requirements 2.8 Disposal of Equipment...

  • Page 22: Intended Purpose Of Equipment

    Equipment Features The InnoWave Unity & Unity 20 sonic irrigator is available in 2 model variations: The Unity has a tank depth of 215.0 mm (8.5 in.). The Unity basket has 8 flush ports. The Unity 20 has a tank depth of 253.4 mm (10.0 in.) and features a safety lock that prevents the lid opening during wash operations.

  • Page 23: Equipment Identification

    InnoWave Unity & Unity 20 Operator Manual Equipment Identification The model reference, serial number, and manufacturer information are displayed on a label inside the chemical enclosure of the sonic irrigator. InnoWave™ Unity Manufactured for: STERIS Corpora�on Sonic Irrigator 5960 Heisley Rd Mentor, OH 44060, USA Medisafe UK Ltd.

  • Page 24: Applied Standards

    InnoWave Unity & Unity 20 Operator Manual Applied Standards Standards that are applicable, subject to regional requirements and model variants made available in those regions, are shown below. Table 2.1 Applied Standards Standard Title ANSI C63.4-2014 American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz.

  • Page 25: Compliance

    InnoWave Unity & Unity 20 Operator Manual Table 2.1 Applied Standards (continued) Standard Title EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use. EMC requirements. General requirements. IEC 62304:2006+AMD1:2015 Medical device software. Software life-cycle processes. IEC 62366-1:2015+AMD1:2020 Medical devices — Part 1: Application of usability engineering to medical devices.
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  • Page 27: Using The Touchscreen Display

    InnoWave Unity & Unity 20 Operator Manual HAPTER Using the Touchscreen Display This chapter describes how to use the touchscreen display. 3.1 The Touchscreen Display 3.2 Screensaver Mode on the Display 3.3 Entering an Operator PIN (if enabled) 3.4 Menu Navigation 3.5 Main Menu Functions...

  • Page 28: The Touchscreen Display

    InnoWave Unity & Unity 20 Operator Manual The Touchscreen Display The touchscreen display is used to adjust wash cycle parameters and to operate the equipment. The display provides information on equipment settings and activity during wash cycle operations. Screensaver Mode on the Display If the sonic irrigator is inactive for more than 10 minutes, the display enters the screensaver mode.

  • Page 29: Menu Navigation

    InnoWave Unity & Unity 20 Operator Manual After entering a valid operator PIN, the main menu controls are unlocked. Menu Navigation On the display, the symbols are used to scroll left and right through the menu. The large symbol in the center and any text below it indicate the current selection. Any operator choices are usually shown at the bottom of the display.

  • Page 30: Main Menu Functions

    InnoWave Unity & Unity 20 Operator Manual Main Menu Functions The main menu provides access to settings for common equipment functions, as described in the table below. To return to the main menu from any selection or sub-menu, touch the symbol at the top-left of the display until the main menu is reached.

  • Page 31: Information On The Display During A Wash Cycle

    InnoWave Unity & Unity 20 Operator Manual Information on the Display During a Wash Cycle Figure 3.1 Example of the display during a wash cycle A. Pause; touch to pause the wash cycle. B. Current wash cycle stage. C. Temperature of fluids (water and chemical mix) in the tank.
  • Page 32 InnoWave Unity & Unity 20 Operator Manual Symbols in the center of the display give additional information on the equipment activity during the wash stages: Symbol Meaning Represents the inlets to tank. Blue represents cold water inlet, red represents hot water inlet, yellow represents chemical inlet. When an inlet is open, allowing fluids into tank, a "stream"...

  • Page 33: Preparing Chemicals

    InnoWave Unity & Unity 20 Operator Manual HAPTER Preparing Chemicals This chapter describes the use of chemicals (detergents) with the sonic irrigator 4.1 Use of Chemicals 4.2 Recommended Chemicals — North America Only 4.3 Recommended Chemicals — Outside North America 4.4 Replacing the Chemical Bottle...

  • Page 34: Use Of Chemicals

    InnoWave Unity & Unity 20 Operator Manual Use of Chemicals The sonic irrigator has been designed to connect to a chemical (detergent) bottle. Detergent is required during the main wash stage of a wash program. The chemical bottle is stored in the sonic irrigator chemical enclosure and detergent is drawn up through a chemical pickup when required by wash program settings.

  • Page 35: Recommended Chemicals - Outside North America

    InnoWave Unity & Unity 20 Operator Manual Recommended Chemicals — Outside North America CAUTION Using non- recommended chemicals, accessories, and replacement parts may cause damage to the equipment and could void both your warranty and guarantee of performance. Item number...

  • Page 36: Replacing The Chemical Bottle

    InnoWave Unity & Unity 20 Operator Manual Replacing the Chemical Bottle The chemical bottle should be regularly replaced with fresh chemical, and whenever chemical is insufficient for planned wash cycles. The quantity of chemical in the bottle should be checked regularly before wash operations.
  • Page 37 InnoWave Unity & Unity 20 Operator Manual Remove the old chemical bottle from the enclosure and take the chemical pickup out of the bottle. Dispose of the old chemical bottle. Remove the cap from the new chemical bottle. Put the chemical pickup into the new bottle.

  • Page 38: Priming The Chemical Pump

    InnoWave Unity & Unity 20 Operator Manual Feed the hose of the chemical pickup into the chemical bottle. Make sure the hose reaches the bottom of the bottle. Close the door of the chemical enclosure. The chemical pump must now be primed to prevent chemical cross-contamination.
  • Page 39 InnoWave Unity & Unity 20 Operator Manual Make sure that there is sufficient chemical in the chemical bottle, and that the chemical pickup is fully inserted into and reaches the bottom of the chemical bottle. Open the lid on the sonic irrigator so that the chemical delivery port inside the tank can be seen.
  • Page 40 InnoWave Unity & Unity 20 Operator Manual On the display, touch Prime Chem. Pump at the bottom of screen. The button changes color to indicate that the chemical pump is now active and pumping chemical from the chemical bottle. The chemical pump will operate and then turn off automatically.
  • Page 41 InnoWave Unity & Unity 20 Operator Manual HAPTER Using the Instrument Basket This chapter describes the use of the basket and loading of instruments into the basket before performing a wash cycle. 5.1 The Instrument Basket 5.2 Removing the Basket from the Tank 5.3 Loading General Instruments...

  • Page 42: The Instrument Basket

    InnoWave Unity & Unity 20 Operator Manual The Instrument Basket The instrument basket is designed to hold instruments for cleaning. Before starting a wash cycle, instruments for cleaning are loaded into the basket, using luer hose connections as required. The basket is then docked in the tank and a wash cycle program selected.

  • Page 43: Removing The Basket From The Tank

    InnoWave Unity & Unity 20 Operator Manual Removing the Basket from the Tank WARNING — Burn hazard Since temperatures within the equipment can reach +60 °C (+140 °F) during and after operation, take care when opening the lid at the end of a wash cycle.

  • Page 44: Loading General Instruments

    InnoWave Unity & Unity 20 Operator Manual Loading General Instruments Instruments with no internal surface (non- cannulated), such as clamps, scissors, and forceps, can be placed directly into the instrument basket. If not already removed, remove the basket from the tank, and move to a loading area away from the sonic irrigator.

  • Page 45: Loading Cannulated Instruments

    InnoWave Unity & Unity 20 Operator Manual Place instruments in the basket, distributing evenly. Make sure instruments do not protrude through the basket or above the top of the basket. Any small instruments that may fall through the basket should be first placed inside a mesh tray, and then placed in the basket.
  • Page 46 InnoWave Unity & Unity 20 Operator Manual Inspect luer hoses and distal connectors. Discard any hoses or connectors that are heavily-soiled or damaged. Select a distal connector that best fits over the end of the instrument. The distal pack, included with the sonic irrigator when shipped, has 4 sizes of distal connector.
  • Page 47 InnoWave Unity & Unity 20 Operator Manual Push the instrument into a distal connector. Do not push the instrument into a distal connector that is much smaller than the instrument end, as this could damage the distal connector silicone opening.
  • Page 48 InnoWave Unity & Unity 20 Operator Manual Place the instrument with distal connector and luer hose into the basket. Distribute instruments evenly around the basket. Make sure instrument does not poke through the basket or point upwards. Attach the luer hose to a basket flush port. Always attach the luer hose to the top- most available flush port.

  • Page 49: Loading Si/S Robotic Instruments

    InnoWave Unity & Unity 20 Operator Manual 11. If more than 8 cannulated instruments are to be processed in one wash cycle, Y luer hoses can be used to facilitate the connection of up to 16 cannulated instruments. Loading Si/S Robotic Instruments...
  • Page 50 InnoWave Unity & Unity 20 Operator Manual If not already removed, remove the basket from the tank, and move to a loading area away from the sonic irrigator. Make sure that luer hoses have no kinks or ruptures. Reject any damaged hose.
  • Page 51 InnoWave Unity & Unity 20 Operator Manual On the instrument body, identify the main flush port. The main flush port usually has and the number 1 next to it, and a dark ring the da Vinci flush port symbol around the port. Push the luer elbow into the main flush port until it remains in place.

  • Page 52: Loading Xi Robotic Instruments

    InnoWave Unity & Unity 20 Operator Manual Attach the luer hose to an available basket flush port. Always attach the luer hose to the top-most available flush port. Push the connector of the luer hose into the port until the retaining clip clicks to hold the hose in position. Pull lightly on the hose to make sure the connection is secure.
  • Page 53 InnoWave Unity & Unity 20 Operator Manual If not already removed, remove the basket from the tank, and move it to a loading area away from the sonic irrigator. Make sure that the luer hoses have no kinks or ruptures. Reject any damaged hose.
  • Page 54 InnoWave Unity & Unity 20 Operator Manual On the Xi robotic instrument body, identify the 2 flush ports on the instrument body. and the numbers 1 The flush ports usually have the da Vinci flush port symbol and 2 next to them. Push the luer elbows into the flush ports on the instrument body until they remain in place.

  • Page 55: Docking The Basket Into The Tank

    InnoWave Unity & Unity 20 Operator Manual Attach the luer hose to an available basket flush port. Always attach the luer hose to the top-most available flush port on a basket flush manifold. Push the connector of the luer hose into the port until the retaining clip clicks to hold the hose in position.
  • Page 56 InnoWave Unity & Unity 20 Operator Manual If the tank is empty, grip the filter and pull up, then towards the middle of the tank to remove it. After cleaning the filter, push it back into position in the tank.
  • Page 57 InnoWave Unity & Unity 20 Operator Manual Lift the basket using both handles. Move the basket slowly and be mindful instruments may move or fall through the basket. If instruments starts to protrude through the basket, they must be repositioned before attempting to place the basket in the tank.
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  • Page 59: Performing A Wash Cycle

    InnoWave Unity & Unity 20 Operator Manual HAPTER Performing a Wash Cycle This chapter describes how to initiate a wash cycle, monitor the progress of a wash cycle, and confirm the completion of a successful wash cycle. The equipment should first be...

  • Page 60: Selecting A Wash Program

    InnoWave Unity & Unity 20 Operator Manual Selecting a Wash Program The wash program that the sonic irrigator uses for the next wash cycle is shown on the Load Instruments screen. The sonic irrigator defaults to the wash program last used: to select a different wash program, follow the procedure below.

  • Page 61: Starting A Wash Cycle

    InnoWave Unity & Unity 20 Operator Manual Starting a Wash Cycle From the main menu, touch repeatedly until the start cycle symbol centered and Load Instruments appears at the bottom of the screen. Confirm that the wash program shown on the display matches the desired wash Selecting a Wash Program program.
  • Page 62 InnoWave Unity & Unity 20 Operator Manual Touch Start at the bottom-left of the Load Instruments - If all loaded screen. The wash cycle will start and progress through each stage as required. PERFORMING A WASH CYCLE...

  • Page 63: Wash Cycle Stages - Unity

    InnoWave Unity & Unity 20 Operator Manual Wash Cycle Stages — Unity The stages of the Complete Wash Cycle program are described below. Note: Other wash cycles may not include all steps described. Confirm basket is docked in tank and ready to...

  • Page 64: Wash Cycle Stages - Unity

    InnoWave Unity & Unity 20 Operator Manual Wash Cycle Stages — Unity 20 The stages of the Complete Wash Cycle program are described below. Note: Other wash cycles may not include all steps described. Confirm basket is docked in tank and ready to start...

  • Page 65: On Completion Of A Wash Cycle

    InnoWave Unity & Unity 20 Operator Manual On Completion of a Wash Cycle This procedure describes the operator actions necessary on the completion of a normal wash cycle, such as set in program 1 Complete Wash Cycle . This procedure does not apply...
  • Page 66 InnoWave Unity & Unity 20 Operator Manual Open the lid slowly and partially to allow hot vapors to escape from the tank. When vapors have escaped, the lid can be opened fully. WARNING — Burn hazard Since temperatures within the equipment can reach +60 °C (+140 °F) during and after operation, take care when opening the lid at the end of a wash cycle.
  • Page 67 InnoWave Unity & Unity 20 Operator Manual When the basket has drained, disconnect luer hoses from basket flush ports by first pressing the release tab on side of the flush port, then pulling the hose out of the port. Inspect luer hoses after disconnection from flush ports. If any luer hose appears damaged, it should be discarded.

  • Page 68: Pausing Or Aborting A Wash Cycle

    InnoWave Unity & Unity 20 Operator Manual 10. Touch OK on Cycle Complete - Unload screen to confirm unloading of instruments. The display returns to Load Instruments screen. 11. The sonic irrigator is now ready for instrument loading and a new wash cycle.

  • Page 69: Wash Cycle Errors

    InnoWave Unity & Unity 20 Operator Manual Touch OK on the display to confirm recognition that the wash cycle was aborted. The tank will be drained of fluids and the display will return to the Load Instruments screen when the tank draining is completed.
  • Page 70 InnoWave Unity & Unity 20 Operator Manual The reason for the abort should be investigated using the reported error code to diagnose the cause. Follow advice given. See Diagnosing Error Codes on page 90. After noting the error code reported, touch OK on the display to confirm that the error has been recognized.

  • Page 71: The Rewash Feature

    InnoWave Unity & Unity 20 Operator Manual HAPTER The Rewash Feature This chapter describes the rewash feature. 7.1 Rewash Program Setting 7.2 The Rewash Counter 7.3 On Completion of a Rewash Cycle THE REWASH FEATURE...

  • Page 72: Rewash Program Setting

    InnoWave Unity & Unity 20 Operator Manual Rewash Program Setting Within a wash program, if the rewash parameter is set above zero, the rewash feature is enabled. When the rewash feature is enabled, the tank fluids do not drain at the end of the first wash cycle.

  • Page 73: On Completion Of A Rewash Cycle

    InnoWave Unity & Unity 20 Operator Manual When the number of times the tank fluids have been used reaches the number set in the rewash program parameters, the tank drains at the end of that cycle, and the operator is not given the option to reuse the tank fluids.
  • Page 74 InnoWave Unity & Unity 20 Operator Manual WARNING — Burn hazard Since temperatures within the equipment can reach +60 °C (+140 °F) during and after operation, take care when opening the lid at the end of a wash cycle. Allow sufficient time for items to cool before handling, cleaning, or commencing maintenance procedures.
  • Page 75 InnoWave Unity & Unity 20 Operator Manual HAPTER Maintenance This chapter describes maintenance of equipment, including periodic cleaning and inspection. 8.1 Important Safety Information 8.2 Daily Cleaning and Inspection 8.3 Weekly Cleaning and Inspection 8.4 Checking the Time and Date Settings 8.5 Performing a Full Decontamination...

  • Page 76: Maintenance

    InnoWave Unity & Unity 20 Operator Manual Important Safety Information WARNING - No user-serviceable parts No user- serviceable parts inside the equipment. To avoid personal injury, improper equipment performance, invalidation of equipment warranty, or other costly damage, service and repair should only be performed by service technicians approved by the equipment manufacturer.

  • Page 77: Daily Cleaning And Inspection

    InnoWave Unity & Unity 20 Operator Manual Daily Cleaning and Inspection The cleaning and inspection described below is a general guide for use. The equipment owner should review and set a cleaning and inspection procedure that is appropriate for their frequency and manner of use.
  • Page 78 InnoWave Unity & Unity 20 Operator Manual Inspect the tank docking ports. Make sure that the ports are clear of any soil and are in a good condition. Make sure that the red silicone o-ring is present and in a good condition.

  • Page 79: Weekly Cleaning And Inspection

    InnoWave Unity & Unity 20 Operator Manual Weekly Cleaning and Inspection Perform all daily cleaning and inspection. See Daily Cleaning and Inspection page 67. Make sure that the mains power cable is not trapped, or damaged. Inspect all drainage connections and hoses for leaks, kinks, or damage.

  • Page 80: Time Setting Adjustment

    InnoWave Unity & Unity 20 Operator Manual 8.4.1 Time Setting Adjustment On the display, within the main menu, touch repeatedly until the clock symbol is centered and the time and date appear below it. Touch Set Time at the bottom of the display.

  • Page 81: Performing A Full Decontamination

    InnoWave Unity & Unity 20 Operator Manual On the Set Date screen, touch to adjust day, month, year settings as required. Touch to return to the main menu. Performing a Full Decontamination Perform the daily cleaning procedure. See Daily Cleaning and Inspection page 67.
  • Page 82 InnoWave Unity & Unity 20 Operator Manual Dock the basket into the tank. Put a solution of 5% non-foaming Sodium Hypochlorite disinfectant into a shallow heat-resistant container (this prevents it from being drained at the start of the cycle). Disinfection solution...

  • Page 83: Accessories And Replacement Parts

    InnoWave Unity & Unity 20 Operator Manual Confirm that the wash cycle completes with no errors. 10. Remove the basket from the tank. 11. If preparing the equipment for shipping, fill out a Decontamination Certificate . See Decontamination Certificate on page 129. Decontamination Certificate MUST be attached to the outside of packing crate.

  • Page 84: Replacement Parts

    InnoWave Unity & Unity 20 Operator Manual 8.6.2 Replacement Parts Item number Description MP22845 Unity instrument basket and hose set MP23284 Unity 20 instrument basket and hose set MP22662 Chemical pickup HOSE002 Water inlet hose with blue indicator HOSE007 Water inlet hose, stainless steel...

  • Page 85: The Supervisor Menu

    InnoWave Unity & Unity 20 Operator Manual HAPTER The Supervisor Menu This chapter describes the use of the supervisor menu. 9.1 Functions Available Through the Supervisor Menu 9.2 Unlocking the Supervisor Menu 9.3 Changing the Supervisor PIN 9.4 Viewing and Editing Wash Programs 9.5 Changing the Language Used by the Display...

  • Page 86: Functions Available Through The Supervisor Menu

    InnoWave Unity & Unity 20 Operator Manual Functions Available Through the Supervisor Menu The supervisor menu unlocks access to following: • Change the PIN used to unlock the supervisor menu. • View factory-set wash programs settings. • Edit user-definable wash programs settings.

  • Page 87: Changing The Supervisor Pin

    InnoWave Unity & Unity 20 Operator Manual Changing the Supervisor PIN IMPORTANT If the supervisor PIN is changed and then forgotten, it can only be reset by a service manufacturer-approved service technician. A service visit to reset the supervisor PIN is not covered by warranty, and will be chargeable to the customer.
  • Page 88 InnoWave Unity & Unity 20 Operator Manual Use the number pad on display to confirm the new 6-digit supervisor PIN. If the new supervisor PIN entered the first and second time do not match, the supervisor PIN will not be changed and you must try again.

  • Page 89: Viewing And Editing Wash Programs

    InnoWave Unity & Unity 20 Operator Manual Viewing and Editing Wash Programs Open (editable) wash programs may not be available on all models. To check that editable wash programs are available on the sonic irrigator, view the wash programs in the supervisor menu.
  • Page 90 InnoWave Unity & Unity 20 Operator Manual On the display, touch or repeatedly until the desired wash program name appears under the wash program symbol . If a padlock symbol appears in the bottom left corner of the screen, the wash program is locked and can only be viewed.
  • Page 91 InnoWave Unity & Unity 20 Operator Manual Pre-wash On the left is the duration of the pre-wash stage in minutes (0 to 20). On the right is the number of times the pre-wash stage is performed (0 to 3). If either value is zero, pre-wash is not performed.
  • Page 92 InnoWave Unity & Unity 20 Operator Manual Rinsing On the left is the water temperature (0 °C to +60 °C, or +32 °F to +140 °F). In the center is the duration in minutes (0 to 20). On the right is the number of times the rinsing stage is performed (0 to 3).

  • Page 93: Changing The Language Used By The Display

    InnoWave Unity & Unity 20 Operator Manual Changing the Language Used by the Display Unlock the supervisor menu using the supervisor PIN. See Unlocking the Supervisor Menu on page 76. On the display, touch repeatedly until the symbol is centered and Language appears.
  • Page 94 InnoWave Unity & Unity 20 Operator Manual Touch OK to confirm the language selection. The language used by the equipment is changed and the display returns to the Language screen. THE SUPERVISOR MENU...

  • Page 95: Downloading Wash Cycle Logs

    InnoWave Unity & Unity 20 Operator Manual HAPTER Downloading Wash Cycle Logs During wash operations, parameters are reported at key stages as an ASCII serial data stream. This cycle log is stored in internal memory and can be downloaded onto a USB flash drive for external reporting and analysis.

  • Page 96: Recommended Usb Flash Drives

    InnoWave Unity & Unity 20 Operator Manual 10.1 Recommended USB Flash Drives The following brands are recommended for use with this equipment: • Toshiba TransMemory • Kingston Data Traveler • SanDisk Cruzer Switch 10.2 Downloading Logs to a USB Flash Drive Make sure the USB flash drive is formatted to FAT32.
  • Page 97 InnoWave Unity & Unity 20 Operator Manual Wait for logs to be copied to the USB flash drive. The display will report the number of files being copied and show a progress bar. When the download to the USB flash drive is complete, the display will show that the copy is complete and that it is safe to remove the USB flash drive from the equipment.
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  • Page 99: Troubleshooting

    InnoWave Unity & Unity 20 Operator Manual HAPTER Troubleshooting This chapter describes error messages that may be shown, and performance issues that may occur during operation of the equipment. When an error message or performance issue occurs, the following tables indicate common causes of errors, and corrective actions.

  • Page 100: Diagnosing Error Codes

    InnoWave Unity & Unity 20 Operator Manual 11.1 Diagnosing Error Codes Use the table below to diagnose and remedy error codes reported on the display. Table 11.1 Error Codes and Remedy Actions Error Error Message Description Code Mains supply to equipment was interrupted during a cycle.
  • Page 101 InnoWave Unity & Unity 20 Operator Manual Table 11.1 Error Codes and Remedy Actions (continued) Error Error Message Description Code Make sure non-foaming chemical is being used. Chamber water level Check equipment and water connections for leaks. If equipment is leaking, contact supplier to arrange a qualified technician inspection.
  • Page 102 InnoWave Unity & Unity 20 Operator Manual Table 11.1 Error Codes and Remedy Actions (continued) Error Error Message Description Code Switch the equipment off then on again. Overflow level sensor invalid If problem persists, contact supplier to arrange a qualified technician inspection.
  • Page 103 InnoWave Unity & Unity 20 Operator Manual Table 11.1 Error Codes and Remedy Actions (continued) Error Error Message Description Code Switch the equipment off, then on again. If problem Sonic generator low persists, contact supplier to arrange a qualified technician power inspection.
  • Page 104 InnoWave Unity & Unity 20 Operator Manual Table 11.1 Error Codes and Remedy Actions (continued) Error Error Message Description Code Fill level sensor invalid Repeat cycle. If problem persists, contact supplier to arrange a qualified technician inspection. Switch the equipment off, then on again.

  • Page 105: Troubleshooting Equipment Performance

    InnoWave Unity & Unity 20 Operator Manual 11.2 Troubleshooting Equipment Performance Use the tables below to diagnose and remedy any performance issues. Observed problem: Sonic irrigator does not power-up. Possible causes and solutions: Make sure that the main disconnect switch is in the ON position and that electrical power is supplied to the equipment.
  • Page 106 InnoWave Unity & Unity 20 Operator Manual Observed problem: Check Chemical appears on the display. Possible causes and solutions: Make sure that there is sufficient chemical required by the wash program and replace the bottle if there is insufficient chemical.
  • Page 107 Make sure that the correct basket is being used with the sonic irrigator. The Unity basket and Unity 20 baskets are NOT interchangeable and can only be used with their own model variant. Baskets from other Steris sonic irrigators are not compatible with the Unity or Unity 20 sonic irrigators.
  • Page 108 InnoWave Unity & Unity 20 Operator Manual Observed problem: Close lid appears on the display. Possible causes and solutions: Make sure that the lid is completely closed. Make sure that instruments in the basket are not preventing the lid from closing.
  • Page 109 Note: The equipment basket should always be used, and the indicator(s) placed inside the basket. Make sure to use only a chemical that is recommended by STERIS and the indicator IFU. Make sure that the chemical dose is as stated in the wash program parameters, and the indicator IFU.

  • Page 110: Opening The Unity 20 Lid After A Power Failure

    InnoWave Unity & Unity 20 Operator Manual 11.3 Opening the Unity 20 Lid After a Power Failure The Unity 20 model has a safety interlock that prevents the lid from being opened during a wash cycle. At the end of the wash cycle, the interlock is released and the lid can be opened.
  • Page 111 InnoWave Unity & Unity 20 Operator Manual HAPTER Wash Programs This chapter describes the wash programs that may be setup on a sonic irrigator when shipped. 12.1 Wash Program Configuration 12.2 Complete Wash Cycle Program 12.3 Soak Cycle Program 12.4 Open Programs 12.5 Decontamination Program...

  • Page 112: Wash Programs

    InnoWave Unity & Unity 20 Operator Manual 12.1 Wash Program Configuration A total of 6 wash programs are stored on the sonic irrigator. The wash programs are set before the equipment is shipped. The table below describes the wash program configuration that is currently shipped.

  • Page 113: Complete Wash Cycle Program

    InnoWave Unity & Unity 20 Operator Manual 12.2 Complete Wash Cycle Program The Complete Wash Cycle program is validated to clean, with certainty, up to 12.0 kg (26.4 lb) of instruments using the Unity, and up to 16.0 kg (35.2 lb) of instruments using the Unity 20.

  • Page 114: Soak Cycle Program

    InnoWave Unity & Unity 20 Operator Manual 12.3 Soak Cycle Program The factory- set Soak Cycle program is precedes normal washing and rinsing and is intended for the processing of heavily-soiled instruments or as a quick wash process before full cleaning.

  • Page 115: Open Programs

    InnoWave Unity & Unity 20 Operator Manual 12.4 Open Programs Three wash programs are populated with default Open wash program parameters . These wash program parameters can adjusted within the supervisor menu to create customer- specific wash program requirements. To edit program parameters see...

  • Page 116: Decontamination Program

    InnoWave Unity & Unity 20 Operator Manual 12.5 Decontamination Program The factory-set Decontamination program can be used to perform a full decontamination of equipment, following the procedure described in Performing a Full Decontamination page 71 . This wash program is locked and can only be adjusted by a manufacturer- approved service technician.

  • Page 117: Specification

    InnoWave Unity & Unity 20 Operator Manual HAPTER Specification This chapter describes performance and physical specifications of the equipment. 13.1 Performance 13.2 Water Consumption - Unity 13.3 Water Consumption - Unity 20 13.4 Power Consumption 13.5 Overall Dimensions and Weight 13.6 Tank Dimensions and Capacity...

  • Page 118: Performance

    InnoWave Unity & Unity 20 Operator Manual 13.1 Performance Aspect Detail Equipment designation Healthcare sonic irrigator Medical device class I Classifications Class 1 electrical shock protection, externally powered No applied parts IP rating: IPX0 Not suitable for use in oxygen-rich environment...

  • Page 119: Water Consumption - Unity

    InnoWave Unity & Unity 20 Operator Manual 13.2 Water Consumption - Unity Water consumption will vary depending on the volume of instruments loaded. The water consumption below describes a complete wash cycle with no instruments loaded. Stage Cold water Hot water...

  • Page 120: Power Consumption

    InnoWave Unity & Unity 20 Operator Manual 13.4 Power Consumption Power consumption will vary depending on the temperature of the wash cycle. The power consumption below describes a complete wash cycle at +40 ºC (+104 ºF), and with no instruments loaded. Stage...

  • Page 121: Tank Dimensions And Capacity

    InnoWave Unity & Unity 20 Operator Manual 13.6 Tank Dimensions and Capacity Tank length (internal) 745.0 mm (29.3 in.) Tank width (internal) 375.0 mm (14.8 in.) Unity: 215.0 mm (8.5 in.) Tank depth (internal) Unity 20: 253.4 mm (10.0 in.) Tank liquid volume (maximum) 35.0 liters (9.2 US gal)

  • Page 122: Languages

    Noise generated during 71 dBA at distance of 1 m (3.3 ft) from front of unit operation STERIS do not recommend the operation of the Unity 20 in environmental conditions higher than 50% relative humidity at +40 ºC (+104 ºF). SPECIFICATION...

  • Page 123: Terms, Definitions, And Symbols

    InnoWave Unity & Unity 20 Operator Manual HAPTER Terms, Definitions, and Symbols This chapter details terms and definitions used throughout this manual, and symbols which may appear on equipment. 14.1 Terms and Definitions 14.2 Visual Symbols TERMS, DEFINITIONS, AND SYMBOLS...

  • Page 124: Terms And Definitions

    InnoWave Unity & Unity 20 Operator Manual 14.1 Terms and Definitions The terms, as defined below, may appear throughout this manual. Abort, Aborting Stopping wash cycle quickly and not allowing equipment to complete the wash program. Accessories Optional devices or fittings that can be used with, or extend the functionality of equipment.
  • Page 125 InnoWave Unity & Unity 20 Operator Manual Cavitation The foundation of ultrasonic cleaning occurs when ultrasonic energy is introduced into a cleaning solution. This energy causes alternating low and high pressure phases. During low pressure phases, minute bubbles (or vacuum cavities) are formed: during high pressure phases, bubbles implode violently.
  • Page 126 InnoWave Unity & Unity 20 Operator Manual Detergent A water-soluble cleansing agent which combines with impurities and dirt to make them more soluble. Dispensing, Dispensation The action of chemical being transported, in controlled measure, from chemical bottle into tank. Distal connector A special connector that attaches to, and facilitates, flushing through hollow and cannulated instruments.
  • Page 127 InnoWave Unity & Unity 20 Operator Manual Irrigation Process of cleaning instruments through the use of controlled water flow and/or spray. See also "flushing". Loading Placing (and/or connecting) instruments to be processed within the equipment basket and then putting basket inside tank.
  • Page 128 InnoWave Unity & Unity 20 Operator Manual Operator Person using equipment according to its intended purpose, as part of their regular work actvity. Overflow An equipment feature that ensures fluid flows to drain in the event that tank is overfilled, and does not spill over unit or floor.
  • Page 129 InnoWave Unity & Unity 20 Operator Manual Program A sequence of actions that equipment performs in order to clean instruments. Also referred to as a "cycle". Protective Earth An earth ground connection to physical ground. When a fault occurs, current flows from the power system to earth.
  • Page 130 InnoWave Unity & Unity 20 Operator Manual Solution A substance dissolved in a liquid, normally water. Sonic irrigation The use of ultrasonic waves to dislodge contaminants from instrument surfaces, and flushing to remove debris from instruments. Spraying A action within the wash cycle, when fluids are pushed (under pressure) through basket nozzles and shower over instruments to assist cleaning.
  • Page 131 InnoWave Unity & Unity 20 Operator Manual Vapor Gaseous particles that may be emitted from a liquid at room temperature or when heated. Warning Advice alerting of a danger that can potentially cause personal injury or death. Xi Instruments A range of instruments made by Intuitive Surgical within the brand of Da Vinci. The cleaning and processing of Xi instruments requires procedures (as described in this manual) that are specific to the instrument type.

  • Page 132: Visual Symbols

    InnoWave Unity & Unity 20 Operator Manual 14.2 Visual Symbols The following symbols may appear on the equipment: Table 14.1 Visual Symbols Symbol Description UL Listed Mark Certifies that equipment meets requirements and standards of Underwriters Laboratories (UL). Accompanied by UL listing reference.
  • Page 133 InnoWave Unity & Unity 20 Operator Manual Table 14.1 Visual Symbols (continued) Symbol Description Manufacturer Catalog Number Accompanied by manufacturer code unique to equipment model. Manufacturer Serial Number Accompanied by manufacturer code unique to this equipment. Medical Device Indicates that this equipment is a medical device, as defined by Medical Device Regulations (MDR) 2017/745.
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  • Page 135: Appendices

    InnoWave Unity & Unity 20 Operator Manual Appendices Appendix A: Service Record Appendix B: Training Records Appendix C: Decontamination Certificate Appendix D: Operator and Supervisor Authorization Codes APPENDICES...

  • Page 136: Appendix A: Service Record

    InnoWave Unity & Unity 20 Operator Manual Appendix A: Service Record The table below should be updated whenever this equipment is serviced, and made available in event of warranty claim or breakdown repair. 6-Month Service 12-Month Service Serviced by Serviced by...

  • Page 137: Appendix B: Training Records

    InnoWave Unity & Unity 20 Operator Manual Appendix B: Training Records The table below can be used for keeping training records. Date Name Title of training Signature of trainer APPENDICES...
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  • Page 139: Appendix C: Decontamination Certificate

    InnoWave Unity & Unity 20 Operator Manual Appendix C: Decontamination Certificate IMPORTANT A full decontamination MUST be done when shipping equipment to supplier for any reason, including returns for repair or servicing. If a completed Decontamination Certificate is not visible on outside of shipping crate, courier and/or supplier CAN REFUSE to accept item(s).
  • Page 140 Operator Manual InnoWave Unity & Unity 20 This page intentionally blank APPENDICES...

  • Page 141: Appendix D: Operator And Supervisor Authorization Codes

    InnoWave Unity & Unity 20 Operator Manual Appendix D: Operator and Supervisor Authorization Codes There are 80 operator numbers each with unique PIN. Operator Operator Operator Operator 2040 4060 6080 8020 2181 4121 6141 8161 2262 4282 6222 8242 2263...
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  • Page 143 InnoWave Unity & Unity 20 Index Compliance 15 Contact details i, 99 Aborting wash cycle See  Wash cycle Accessories 6, 24, 73 Applied standards See  Standards Date (adjusting) See  Time and Date Audio 108 Date of manufacture 13, 122 Decontamination...
  • Page 144 InnoWave Unity & Unity 20 protective earth 3, 122 Lifting (equipment) See  Transportation supply voltage 94 Luer hoses 32, 35, 71, 92, 96 Environment altitude range 112 ambient operating temperature 112 heat output ii maximum humidity 112 Maintenance noise generated 112 cleaning (daily) ii, 63, 67, 69, 71 Errors See ...
  • Page 145 InnoWave Unity & Unity 20 performance ii, 95 Safety precautions ii, 2, 66 breathing hazard 2 Ultrasonic system 108 burn hazard 4, 33, 56, 64 chemical burn hazard 3, 26 chemical hazard 5 data port 86 electric shock hazard 3, 122...
  • Page 146 InnoWave Unity & Unity 20 pressure (supply) 8, 90, 99 temperature 4, 33, 56, 64, 79, 92, 108 Weight maximum load 111 maximum operating 110 Xi robotic (da Vinci) See  Instruments INDEX...

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