Page 1 InnoWave™ Ultra Sonic Irrigator 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 InnoWave Ultra Sonic Irrigator Operator Manual Revision History Revision Date Summary 19 July 2018 Not released. For internal alignment of revision numbering only. 19 Nov 2018 Labeling and manufacturing address change. 20 Feb 2019 See revision 6 for details of changes. 20 Feb 2019 Labeling and manufacturing address change.
Page 5: Table Of Contents
InnoWave Ultra Sonic Irrigator 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 Recommended Operator Training General information 2.1 Intended Purpose of Equipment 2.2 Equipment Features 2.3 Equipment Identification 2.4 Manufacturer Information...
Page 6 InnoWave Ultra Sonic Irrigator Operator Manual 4.4 Loading Cannulated Instruments 4.5 Unloading Instruments from the Basket Performing a Wash Cycle 5.1 The Touchscreen Display 5.1.1 Screensaver Mode on the Display 5.1.2 Entering an Operator PIN (if enabled) 5.1.3 Menu Navigation 5.1.4 Main Menu Functions 5.2 Outline for Performing a Wash Cycle 5.3 Cleaning Before Filling the Tank...
Page 7 InnoWave Ultra Sonic Irrigator Operator Manual 6.4.2 Date Setting Adjustment 6.5 Performing a Full Decontamination 6.6 Accessories and Replacement Parts 6.7 Equipment Servicing The Supervisor Menu 7.1 Functions Available Through the Supervisor Menu 7.2 Unlocking the Supervisor Menu 7.3 Changing the Supervisor PIN 7.4 Changing the Language Used by the Display Downloading Wash Cycle Logs 8.1 Recommended USB Flash Drives...
Page 8 InnoWave Ultra Sonic Irrigator Operator Manual Terms, Definitions, and Symbols 11.1 Terms and Definitions 11.2 Visual Symbols Appendices Appendix A: Service Record Appendix B: Training Records Appendix C: Decontamination Certificate Appendix D: Operator and Supervisor Authorization Codes Index TABLE OF CONTENTS...
Page 9: Safety Information
InnoWave Ultra Sonic Irrigator 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 all personnel understand the contents of this manual. This manual contains important information on the proper use and maintenance of this equipment.
Page 10: Safety Precautions
InnoWave Ultra Sonic Irrigator 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 the equipment.
Page 11 InnoWave Ultra Sonic Irrigator Operator Manual WARNING — Electric shock hazard To avoid 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. Do not remove any panel or attempt to gain access to the interior of the electrical cabinet.
Page 12 InnoWave Ultra Sonic Irrigator 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 13 InnoWave Ultra Sonic Irrigator Operator Manual WARNING — No user-serviceable parts No user-serviceable parts inside the equipment. To avoid personal injury, improper equipment performance, invalidation of the equipment warranty, or other costly damage, service and repair should only be performed by a service technician approved by the equipment manufacturer.
Page 14 InnoWave Ultra Sonic Irrigator 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 15: Personal Protective Equipment
InnoWave Ultra Sonic Irrigator 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 16: Environmental Conditions
InnoWave Ultra Sonic Irrigator 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 (50 kPa to 106 kPa) Humidity range: 30% to 90% relative humidity...
Page 17 InnoWave Ultra Sonic Irrigator 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 GENERAL INFORMATION...
Page 18: Intended Purpose Of Equipment
InnoWave Ultra Sonic Irrigator Operator Manual Intended Purpose of Equipment The InnoWave Ultra Sonic Irrigator is designed to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both the interior and exterior of lumened instruments.
Page 19 InnoWave Ultra Sonic Irrigator Operator Manual Figure 2.1 Front view, lid closed Lid Magnet Lid Seal Figure 2.2 Front view, lid open GENERAL INFORMATION...
Page 20 InnoWave Ultra Sonic Irrigator Operator Manual Supply Cable Figure 2.3 Rear view, lid closed GENERAL INFORMATION...
Page 21: Equipment Identification
Unit 7 & 8 Stor�ord Hall IWULTRAPL www.STERIS.com Industrial Park, Dunmow Road Bishop’s Stor�ord Her�ordshire, CM23 5GZ 0119 12345 00 STERIS Ireland Limited IDA Business and Technology Park 110VAC 60Hz Tullamore, County Oﬀaly R35 X865, Ireland 1.2kW 2020-04-01 DOC11183 Issue 3...
Page 22: Applied Standards
InnoWave Ultra Sonic Irrigator 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 23: Compliance
InnoWave Ultra Sonic Irrigator Operator Manual Table 2.1 Applied Standards (continued) Standard Title IEC 62366-1:2015+AMD1:2020 Medical devices — Part 1: Application of usability engineering to medical devices. Compliance This equipment has been designed to perform within the guidelines recommended by international decontamination standards.
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Page 25: Connecting The Equipment
InnoWave Ultra Sonic Irrigator Operator Manual HAPTER Connecting the Equipment Before the ultrasonic cleaner can be operated it must be unpacked and connected to a site drain using the hose provided. If the equipment owner requires assistance in connecting the equipment, this should be sought from the supplier. 3.1 Unpacking 3.2 Enclosed Items Checklist 3.3 Connecting the Drain Hose...
Page 26: Unpacking
InnoWave Ultra Sonic Irrigator Operator Manual Unpacking Remove the equipment from the packing crate and remove all external packing. Open the lid and remove any protective packing and loose items from inside the tank. Enclosed Items Checklist Make sure all items, as described in the below, are present.
Page 27: Connecting The Drain Hose
InnoWave Ultra Sonic Irrigator Operator Manual Table 3.1 Enclosed Items (continued) Item Image Description Hose clamp, 22 to 32 mm 1/2 in. x 20 mm hose adapter Flat rubber washer 20 mm Disposable recirculation filter pack of 24 9-way pin to pin serial cable, male to female Connecting the Drain Hose Unpack the hose adapter and the flat rubber washer.
Page 28 InnoWave Ultra Sonic Irrigator Operator Manual Push the washer over the threaded end of the hose adapter up to the shoulder. Locate the drain outlet. The drain outlet is on the rear of the sonic irrigator and is labeled DRAIN. Put the threaded end of the hose adapter into the drain outlet and turn clockwise by hand until tight.
Page 29 InnoWave Ultra Sonic Irrigator Operator Manual Unpack the drain hose and the hose clamp. Identify the thinner end of the drain hose: this end will connect to the drain adapter attached in step 5. Put this end of the drain hose through the hose clamp. Push the thinner end of the drain hose onto the hose adapter.
Page 30: Fitting A Recirculation Filter Into The Tank Drain
InnoWave Ultra Sonic Irrigator Operator Manual The free end of the drain hose should be inserted into a site drain fitted with a drain trap. The drain hose must not loop or kink and must not rise above the height of the drain outlet at the rear of the equipment.
Page 31 InnoWave Ultra Sonic Irrigator Operator Manual If a recirculation filter is present in the tank drain, remove it by pulling the tab up. Make sure the recirculation filter is clean and undamaged. If a filter is not present, or is heavily soiled or damaged, unpack a new recirculation filter. Refit the filter removed in the previous step, or fit a new recirculation filter by pushing the filter into the tank drain.
Page 32: Switching On Electrical Power
InnoWave Ultra Sonic Irrigator Operator Manual Switching on Electrical Power Switch on power to using the isolation switch of the external power socket into which the equipment is plugged. Switch on the power on the rear of the sonic irrigator. When the switch is in the ON position and power is supplied to the sonic irrigator, the switch will be illuminated.
Page 33: Using The Instrument Basket
InnoWave Ultra Sonic Irrigator Operator Manual HAPTER Using the Instrument Basket This chapter describes the loading of instruments into the basket before performing a wash cycle, and the unloading of instruments after processing. 4.1 The Instrument Basket 4.2 Removing the Basket from the Tank 4.3 Loading General Instruments 4.4 Loading Cannulated Instruments 4.5 Unloading Instruments from the Basket...
Page 34: The Instrument Basket
InnoWave Ultra Sonic Irrigator Operator Manual The Instrument Basket The instrument basket has 6 flush ports for lumen flushing of cannulated instruments. The basket can be used to process instruments of the following types: General surgical instruments Cannulated (lumened) instruments The instrument basket can be loaded with a mix of general and cannulated instruments.
Page 35: Removing The Basket From The Tank
InnoWave Ultra Sonic Irrigator Operator Manual Removing the Basket from the Tank The basket should always be removed from the tank for loading and unloading of instruments. Never place instruments directly into 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 36 InnoWave Ultra Sonic Irrigator Operator Manual Grip the basket with both hands and pull the basket up, keeping it level until completely free from the tank. With the basket above the tank, tilt the basket to allow any fluids to drain back into the tank, then move the basket to a draining area away from the sonic irrigator.
Page 37: Loading General Instruments
InnoWave Ultra Sonic Irrigator Operator Manual Loading General Instruments General (non- cannulated) instruments with no internal surface, such as clamps, scissors, and forceps, can be placed directly into the basket. Open mechanical instruments, such as scissors and clamps. Place instruments in the basket, distributing evenly. Make sure instruments do not protrude through the basket or above the top of the basket.
Page 38: Loading Cannulated Instruments
InnoWave Ultra Sonic Irrigator Operator Manual Loading Cannulated Instruments Cannulated (lumened) instruments should be attached to basket flush ports to receive flushing during the wash cycle. A standard basket luer hose and a suitable- sized distal connector will be required to attach each instrument to a basket flush port. Inspect the basket.
Page 39 InnoWave Ultra Sonic Irrigator Operator Manual Select a distal connector that best fits over the end of the instrument. The distal pack, included with the equipment when shipped, has 4 sizes of distal connector. The instrument should be able to push through the silicone opening of the distal connector and not fall out, but not be held tightly as the area being clamped will not be cleaned.
Page 40 InnoWave Ultra Sonic Irrigator Operator Manual Place the instrument with attached distal connector and luer hose into the basket. Make sure the instrument does not poke through the basket or point upwards. Attach the luer hose to a basket flush port. Push the connector of the luer hose into a port until it clicks into position.
Page 41: Unloading Instruments From The Basket
InnoWave Ultra Sonic Irrigator Operator Manual Unloading Instruments from the Basket IMPORTANT It is recommended that hoses are removed one at a time in order to inspect the condition of each luer hose and connection, and identify any instruments requiring reprocessing.
Page 42 InnoWave Ultra Sonic Irrigator Operator Manual Turn the luer lock counter-clockwise to disconnect the luer hose from the distal connector. Pull the instrument out of the distal connector. Inspect the luer hose and distal connector for ruptures or damage. Discard any damaged luer hose or distal connector.
Page 43: Performing A Wash Cycle
InnoWave Ultra Sonic Irrigator Operator Manual HAPTER Performing a Wash Cycle This chapter describes how to perform a wash cycle, monitor progress of a wash cycle, and confirm completion of a successful wash cycle. 5.1 The Touchscreen Display 5.2 Outline for Performing a Wash Cycle 5.3 Cleaning Before Filling the Tank 5.4 Putting the basket into the tank 5.5 Adjusting Wash Program Parameters...
Page 44: The Touchscreen Display
InnoWave Ultra Sonic Irrigator Operator Manual The Touchscreen Display The touchscreen display is used to adjust wash cycle parameters and operate the equipment. The display provides information on equipment settings and activity during a wash cycle operation. 5.1.1 Screensaver Mode on the Display If the ultrasonic cleaner is inactive for more than 10 minutes, the display enters the screensaver mode.
Page 45: Entering An Operator Pin (If Enabled)
InnoWave Ultra Sonic Irrigator Operator Manual 5.1.2 Entering an Operator PIN (if enabled) If the equipment has been setup to require an operator authorization code before operation, Enter Pin Number appears after power- on. Operator PIN codes are listed in Operator and Supervisor Authorization Codes on page 115.
Page 46: Menu Navigation
InnoWave Ultra Sonic Irrigator Operator Manual 5.1.3 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 47: Main Menu Functions
InnoWave Ultra Sonic Irrigator Operator Manual 5.1.4 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 48: Outline For Performing A Wash Cycle
InnoWave Ultra Sonic Irrigator Operator Manual Outline for Performing a Wash Cycle An outline flow diagram for performing a wash cycle is shown below, including operator actions to fill and drain the tank, and add chemical. Depending on wash cycle settings, and whether the operator decides to drain and refill the tank between wash cycle, not all steps may be performed in a particular instance.
Page 49: Cleaning Before Filling The Tank
InnoWave Ultra Sonic Irrigator Operator Manual Cleaning Before Filling the Tank The following cleaning should always be performed before filling the tank. Open the lid fully. With a clean cloth and disinfectant cleaner, wipe the lid seal and the lid magnet. Remove the recirculation filter from the tank drain.
Page 50 InnoWave Ultra Sonic Irrigator Operator Manual Clean the water level sensor with a soft nylon brush or non-greasy alcohol wipes. Clean the tank port with a soft nylon brush or non-greasy alcohol wipes. With a clean cloth and disinfectant cleaner, wipe all internal surfaces of the tank if the tank is empty, otherwise wipe all exposed internal surfaces of the tank above the water level.
Page 51: Putting The Basket Into The Tank
InnoWave Ultra Sonic Irrigator Operator Manual Putting the basket into the tank The basket should be put into the tank and connected to the tank port before attempting to start a wash cycle. Make sure instruments are contained within the basket and are not in contact with either the walls or floor of the tank.
Page 52 InnoWave Ultra Sonic Irrigator Operator Manual Slowly lower the basket into the tank. If any instruments move so that they poke through the basket, reposition them before putting the basket into the tank. If necessary, move the instruments in the basket so that the tank port can be accessed.
Page 53: Adjusting Wash Program Parameters
InnoWave Ultra Sonic Irrigator Operator Manual Make sure that no instruments protrude through or above the basket and that no instruments are pointing upwards. Close the lid fully. Adjusting Wash Program Parameters The wash program parameters can be adjusted after the operator confirms instrument loading on the display.
Page 54 InnoWave Ultra Sonic Irrigator Operator Manual The Select Program screen appears after confirmation of instrument loading. The parameters used for the previous wash cycle are recalled. For each parameter, touch repeatedly, as necessary, to adjust the value to requirements. The function and range of each adjustable wash program parameter is shown in the table below.
Page 55: Tank Water Temperature Limits
InnoWave Ultra Sonic Irrigator Operator Manual 5.5.1 Tank Water Temperature Limits Water temperature inside the tank must remain within limits defined by the wash cycle temperature and the maximum operating temperature for the equipment. Minimum Tank Water Temperature Limit The minimum permitted temperature for tank water is 24 °C (43.2 °F) below the temperature set for the wash cycle.
Page 56 InnoWave Ultra Sonic Irrigator Operator Manual Open the lid fully. The Please Fill Tank screen appears after the operator confirms the wash program Adjusting Wash Program Parameters settings, as described in on page 45. Make sure the drain outlet valve is closed by checking that the drain lever is turned clockwise as far as possible.
Page 57 InnoWave Ultra Sonic Irrigator Operator Manual Start filling the tank from hot and cold water hoses connected to site water supplies. The current water temperature is shown on the display. The display will also advise whether the temperature is too hot or too cold compared to the temperature required by the wash program parameter.
Page 58 InnoWave Ultra Sonic Irrigator Operator Manual When fluids reach the water level sensor inside the tank, the ultrasonic cleaner detects that the full level is achieved and the display changes to indicate that the tank is filled. Turn off all water supplies. Close the lid.
Page 59: Adding Chemicals To The Tank
InnoWave Ultra Sonic Irrigator Operator Manual Adding Chemicals to the Tank A measured dose of chemical (detergent or cleaner) should be poured directly into the tank during filling. Refer to the table (s) on Recommended chemicals on the next page. The operator should wear personal protective equipment when handling chemicals, and observe precautions and instructions on the chemical label.
Page 60: Recommended Chemistries - North America Only
InnoWave Ultra Sonic Irrigator Operator Manual 5.7.1 Recommended Chemistries — North America Only Item Ref. Description 1C2408 Prolystica™ 2X HP enzymatic manual cleaner, 4 x 1.0 US gal (4 x 3.78 L) 1C2410 Prolystica™ 2X HP enzymatic manual cleaner, 2.5 US gal (9.46 L) 1C3308 Prolystica™...
Page 61 InnoWave Ultra Sonic Irrigator Operator Manual If all procedures above are performed in order, If all loaded Press Start appears on the display. Touch the symbol in the center of the display to start the wash cycle. The wash cycle proceeds through heating, degassing, and washing stages. See Information on the Display During a Wash Cycle on the next page for information on the meaning of symbols appearing on the display during a wash cycle.
Page 62: Information On The Display During A Wash Cycle
InnoWave Ultra Sonic Irrigator Operator Manual Information on the Display During a Wash Cycle Figure 5.1 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. D.
Page 63: On Completion Of A Wash Cycle
InnoWave Ultra Sonic Irrigator Operator Manual 5.10 On Completion of a Wash Cycle At the end of a wash cycle, a chime is emitted and Cycle Complete appears on the display. Touch Unload on the display to confirm that the cycle completed with no errors.
Page 64 InnoWave Ultra Sonic Irrigator Operator Manual Remove the basket from the tank. See Removing the Basket from the Tank page 27. Unload instruments from the basket. See Unloading Instruments from the Basket on page 33. WARNING If a luer hose or connector, or luer hose appears restricted due to instrument movement, the instrument should be reprocessed.
Page 65: Pausing Or Aborting A Wash Cycle
InnoWave Ultra Sonic Irrigator Operator Manual 5.11 Pausing or Aborting a Wash Cycle During operation it is possible to pause or abort the wash cycle if required. During the wash cycle, touch the symbol located at the top-left of the display. The wash cycle is immediately paused and Cycle Paused appears on the display.
Page 66 InnoWave Ultra Sonic Irrigator Operator Manual WARNING When an error occurs during a wash cycle, the load may be contaminated and require reprocessing. Review the cycle log to establish if the wash cycle completed before the error. If the error interrupted the wash cycle, repeat the cycle to reprocess the load. If the error persists use another equipment or an alternative cleaning process (according to facility procedure) and contact the equipment supplier for equipment servicing.
Page 67: Emptying The Tank
InnoWave Ultra Sonic Irrigator Operator Manual 5.13 Emptying the Tank The tank fluids may be used for multiple wash cycles and do not need to be emptied at the end of every wash cycle. It is recommended that the tank fluids are used for between 4 and 10 wash cycles.
Page 68 InnoWave Ultra Sonic Irrigator Operator Manual On the display, touch Drain Pump to turn on the drain pump. The button changes color to indicate that the drain pump is operating. Fluids are pumped from the tank and out through the drain hose. When fluids have drained, and the tank is empty, touch Drain Pump to turn off the drain pump.
Page 69: Maintenance
InnoWave Ultra Sonic Irrigator Operator Manual HAPTER Maintenance This chapter describes maintenance of the equipment, including periodic cleaning and inspection. WARNING — No user-serviceable parts No user-serviceable parts inside the equipment. To avoid personal injury, improper equipment performance, invalidation of the equipment warranty, or other costly damage, service and repair should only be performed by a service technician approved by the equipment manufacturer.
Page 70: Important Safety Information
InnoWave Ultra Sonic Irrigator Operator Manual Important Safety Information Before performing any maintenance, make sure that the mains power is disconnected. All maintenance procedures should be carried out in a well-lit environment: the recommended minimum lighting level is 500 lux (46.5 foot-candle). Follow the recommended safety precautions for cleaning products in use.
Page 71: Daily Cleaning And Inspection
InnoWave Ultra Sonic Irrigator 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. Open the lid fully.
Page 72 InnoWave Ultra Sonic Irrigator Operator Manual If the tank is empty, remove the recirculation filter from the drain. Inspect the condition of the filter. If the filter has been used for 10 wash cycles or is heavily soiled, replace it with a new filter. Otherwise remove any soil, clean with a disinfectant cleaner and then rinse under running water.
Page 73: Weekly Cleaning And Inspection
InnoWave Ultra Sonic Irrigator Operator Manual With a clean cloth and disinfectant cleaner, wipe all internal surfaces of the tank if the tank is empty, otherwise all exposed internal surfaces above the water level. With a clean cloth and disinfectant cleaner, wipe all external surfaces of the sonic irrigator.
Page 74: Time Setting Adjustment
InnoWave Ultra Sonic Irrigator Operator Manual To view the current time and date setting, from the main menu, touch repeatedly on until the clock symbol is centered. The current time and date settings appear below the clock symbol. The touchscreen buttons below the current time and date are used to adjust settings.
Page 75: Date Setting Adjustment
InnoWave Ultra Sonic Irrigator Operator Manual 6.4.2 Date 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 Date at the bottom of the display. On the Set Date screen, touch to adjust day, month, year settings as required.
Page 76: Performing A Full Decontamination
InnoWave Ultra Sonic Irrigator Operator Manual Performing a Full Decontamination Perform a daily cleaning procedure according to Daily Cleaning and Inspection page 63. Attach luer hoses to all basket flush ports. Put the basket in the tank and connect the basket flush manifold to the tank port. Put a disinfectant solution of 5% non-foaming Sodium Hypochlorite into the tank.
Page 77 InnoWave Ultra Sonic Irrigator Operator Manual On the display, touch repeatedly until the start cycle symbol centered and Load Instruments appears below it. Touch Load Instruments to proceed to the wash program parameters. Adjust the wash program parameters screen (temperature set-point, wash duration) as advised on the disinfectant solution instructions.
Page 78 InnoWave Ultra Sonic Irrigator Operator Manual 12. After 15 minutes has elapsed, touch Resume on the display to continue the wash cycle. 13. Confirm that the wash cycle completed with no errors. 14. Open the drain valve by turning the drain lever counter-clockwise as far as it will move.
Page 79 InnoWave Ultra Sonic Irrigator Operator Manual 16. Touch Drain Pump to turn on the drain pump. 17. Wait for the tank to empty completely. 18. When the tank is empty, touch Drain Pump to turn off the drain pump. 19. Turn the drain lever clockwise as far as it will move to close the drain valve. 20.
Page 80: Accessories And Replacement Parts
InnoWave Ultra Sonic Irrigator Operator Manual 23. If preparing equipment for shipping, fill out a Decontamination Certificate. See Decontamination Certificate on page 113. If the Decontamination Certificate is not visible, the courier and/or the supplier can refuse to accept item(s). Accessories and Replacement Parts A range of manufacturer-approved accessories and replacement parts may be purchased from your supplier.
Page 81: Equipment Servicing
InnoWave Ultra Sonic Irrigator Operator Manual Equipment Servicing It is recommended that this equipment is serviced every 6 months. Servicing should only be performed by a supplier-approved service technician. When the equipment is serviced, the service technician will update the service record Service Record included in this manual.
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Page 83 InnoWave Ultra Sonic Irrigator Operator Manual HAPTER The Supervisor Menu This chapter describes the supervisor menu. 7.1 Functions Available Through the Supervisor Menu 7.2 Unlocking the Supervisor Menu 7.3 Changing the Supervisor PIN 7.4 Changing the Language Used by the Display THE SUPERVISOR MENU...
Page 84: Functions Available Through The Supervisor Menu
InnoWave Ultra Sonic Irrigator Operator Manual Functions Available Through the Supervisor Menu The supervisor menu unlocks access to following: • Change the PIN used to unlock the supervisor menu. • Change the language used by the display and cycle records. Unlocking the Supervisor Menu On the display, from the main menu, touch repeatedly until the supervisor...
Page 85: Changing The Supervisor Pin
InnoWave Ultra Sonic Irrigator Operator Manual Changing the Supervisor PIN IMPORTANT If the supervisor PIN is changed and then forgotten, it can only be reset by a manufacturer-approved service technician. A service visit to reset the supervisor PIN is not covered by warranty, and is chargeable to the customer. Unlock the Supervisor Menu using the supervisor PIN.
Page 86 InnoWave Ultra Sonic Irrigator 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. If the new supervisor PIN entered the first and second time match, the supervisor PIN is changed and the display will return to Enter New Pin .
Page 87: Changing The Language Used By The Display
InnoWave Ultra Sonic Irrigator 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. Touch once on Language at the bottom of the display.
Page 88 InnoWave Ultra Sonic Irrigator 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 89: Downloading Wash Cycle Logs
InnoWave Ultra Sonic Irrigator 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 connected USB flash drive for external reporting and analysis.
Page 90: Recommended Usb Flash Drives
InnoWave Ultra Sonic Irrigator Operator Manual Recommended USB Flash Drives The following brands are recommended for use with this equipment: • Toshiba TransMemory • Kingston Data Traveler • SanDisk Cruzer Switch Downloading Logs to a USB Flash Drive Make sure the USB flash drive is formatted to FAT32. Insert the USB flash drive into the data port located on the side of the sonic irrigator.
Page 91 Touch OK on the display to return to the main menu. Remove the USB flash drive from the data port. On the USB flash drive, the wash cycle logs are saved in the following location: STERIS\<machine serial number>\<cycle range>\<cycle number>.txt DOWNLOADING WASH CYCLE LOGS...
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Page 93: Troubleshooting
InnoWave Ultra Sonic Irrigator 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. If an error cannot be diagnosed and corrected, or a problem occurs which is not described in this manual, please contact supplier.
Page 94: Diagnosing Error Codes
InnoWave Ultra Sonic Irrigator Operator Manual Diagnosing Error Codes Use the table below to diagnose and remedy error codes reported on the display. Table 9.1 Error Codes and Remedy Actions Error Error Message Description Code Mains supply to equipment was interrupted during a cycle. Mains power removed Turn equipment back on and repeat cycle.
Page 95 InnoWave Ultra Sonic Irrigator Operator Manual Table 9.1 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 96: Troubleshooting Equipment Performance
InnoWave Ultra Sonic Irrigator Operator Manual Troubleshooting Equipment Performance Use the tables below to diagnose and remedy any performance issues. Observed problem: Equipment does not power-up. Possible causes and solutions: Make sure that electrical power is supplied to the equipment. Facility power may be incorrect for the equipment.
Page 97 InnoWave Ultra Sonic Irrigator Operator Manual Observed problem: Please close lid shown on the display. Possible causes and solutions: Make sure that the lid is completely closed. Make sure that the instruments in the basket are not preventing the lid from closing.
Page 98 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 chemical dose is as stated in the wash program parameters, and the indicator IFU.
Page 99: Specification
InnoWave Ultra Sonic Irrigator Operator Manual HAPTER Specification This chapter provides information on the performance and physical specifications of the equipment. 10.1 Performance 10.2 Electrical Supply Requirement 10.3 Site Drain Requirement 10.4 Overall Dimensions and Weight 10.5 Tank Dimensions and Capacity 10.6 Basket Dimensions and Capacity 10.7 Languages 10.8 Environmental Performance...
Page 100: Performance
InnoWave Ultra Sonic Irrigator Operator Manual 10.1 Performance 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 Designed for continuous use Intended purpose Internal and external cleaning of surgical instruments, hollow-ware and associated products.
Page 101: Electrical Supply Requirement
InnoWave Ultra Sonic Irrigator Operator Manual 10.2 Electrical Supply Requirement Supply current 10 A (protected) All model variants Power: 1.2 kW Mains supply voltage fluctuations up to ±10% of nominal voltage Transient over- voltages typically present on mains supply (Over-voltage Category II) Pollution Degree 2 Voltage: 110 Vac 1P+N (100 Vac to 127 Vac) IWULTRA, IW521020-...
Page 102: Overall Dimensions And Weight
InnoWave Ultra Sonic Irrigator Operator Manual 10.4 Overall Dimensions and Weight metric US Units External height (lid closed) 364 mm 14.3 in. External height (lid open) 709 mm 27.9 in. External width 757 mm 29.8 in. External depth 458 mm 18.0 in. Net weight (dry) 26.7 kg 58.8 lb...
Page 103: Tank Dimensions And Capacity
InnoWave Ultra Sonic Irrigator Operator Manual 10.5 Tank Dimensions and Capacity Metric US Units Length 627 mm 24.7 in. Width 274 mm 10.8 in. Depth 154 mm 6.1 in. Maximum liquid volume 20.0 liters 5.2 US gal Total volume 28.0 liters 7.4 US gal SPECIFICATION...
Page 104: Basket Dimensions And Capacity
InnoWave Ultra Sonic Irrigator Operator Manual 10.6 Basket Dimensions and Capacity Metric US Units Basket length 624 mm 24.6 in. Basket width 259 mm 10.2 in. Basket depth 141 mm 5.6 in. Maximum load weight 5.0 kg 11.0 lb Maximum instrument size 617 x 260 x 129 mm 24.3 x 10.2 x 5.1 in.
Page 105: Environmental Performance
InnoWave Ultra Sonic Irrigator Operator Manual 10.8 Environmental Performance Altitude range Interior only, altitude up to 2000 m (6562 ft) Ambient operating +5 ºC to +40 ºC (+41 ºF to +104 ºF) temperature range 80% relative humidity for up to +31 ºC (+88 ºF) decreasing linearly Maximum humidity to 50% relative humidity at +40 ºC (+104 ºF) Noise generated...
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Page 107 InnoWave Ultra Sonic Irrigator Operator Manual HAPTER Terms, Definitions, and Symbols This chapter details terms and definitions used throughout this manual, and symbols which may appear on the equipment. 11.1 Terms and Definitions 11.2 Visual Symbols TERMS, DEFINITIONS, AND SYMBOLS...
Page 108: Terms, Definitions, And Symbols
InnoWave Ultra Sonic Irrigator Operator Manual 11.1 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. Basket A perforated stainless steel deep tray or frame, designed to hold or contain instruments during wash operation.
Page 109 InnoWave Ultra Sonic Irrigator Operator Manual Chamber Large cavity within equipment where instruments are washed. Also refered to as "tank". Chemical A water-soluble substance used to assist cleaning during a wash cycle. Often refers to the use of "detergent". Concentration A measure of the amount of dissolved substance contained per unit of volume.
Page 110 InnoWave Ultra Sonic Irrigator Operator Manual Effluent Waste fluids, expelled from tank when a draining action is performed. Flush, Flushing The action of pushing washing fluids through a hollow vessel or instrument. Instrument Miscellaneous medical tools, such a as clamps, scissors, spreaders and picks that require cleaning before reuse.
Page 111 InnoWave Ultra Sonic Irrigator Operator Manual Luer hose A hose that connects to either instrument port or to distal connector to facilitate flushing. Lumen A hollow channel or narrow cavity. May refer to feature within medical instuments and/or connectors to such intruments. Maintenance Periodic actions required to keep equipment in such condition that it may be utilized, at its original or designed capacity and efficiency, and for its intended purpose.
Page 112 InnoWave Ultra Sonic Irrigator Operator Manual Processing A general term used to describe a series of actions intended to clean instruments, or prepare intsruments for secondary cleaning using other equipment. Program A sequence of actions that equipment performs in order to clean instruments. Also referred to as a "cycle".
Page 113 InnoWave Ultra Sonic Irrigator Operator Manual Sonic irrigation The use of ultrasonic waves to dislodge contaminants from instrument surfaces, and flushing to remove debris from instruments. Supervisor An operator who is able to access Supervisor Menu by using a valid supervisor identification number.
Page 114 InnoWave Ultra Sonic Irrigator Operator Manual Warning Advice alerting of a danger that can potentially cause personal injury or death. TERMS, DEFINITIONS, AND SYMBOLS...
Page 115: Visual Symbols
InnoWave Ultra Sonic Irrigator Operator Manual 11.2 Visual Symbols The following symbols may appear on the equipment: Table 11.1 Visual Symbols Symbol Description UL Listed Mark Certifies that equipment meets requirements and standards of Underwriters Laboratories (UL). Accompanied by UL listing reference. FCC Declaration of Conformity Certifies that electromagnetic interference from device is under limits approved by Federal Communications Commission.
Page 116 InnoWave Ultra Sonic Irrigator Operator Manual Table 11.1 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.
Page 117: Appendices
InnoWave Ultra Sonic Irrigator Operator Manual Appendices Appendix A: Service Record Appendix B: Training Records Appendix C: Decontamination Certificate Appendix D: Operator and Supervisor Authorization Codes APPENDICES...
Page 118: Appendix A: Service Record
Operator Manual InnoWave Ultra Sonic Irrigator Appendix A: Service Record The table below should be updated whenever this equipment is serviced, and made available in the event of a warranty claim or a breakdown repair. 6-Month Service 12-Month Service Serviced by Serviced by Cycles since last service Cycles since last service...
Page 119: Appendix B: Training Records
InnoWave Ultra Sonic Irrigator 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 121: Appendix C: Decontamination Certificate
InnoWave Ultra Sonic Irrigator 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).
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Page 123: Appendix D: Operator And Supervisor Authorization Codes
InnoWave Ultra Sonic Irrigator 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 4383 6323 8343 2484...
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Page 125: Index
InnoWave Ultra Sonic Irrigator Index Display (touchscreen) 36 Disposal of equipment 15, 108 WEEE directive 108 Distal connector 26, 30, 34 Aborting wash cycle See Wash cycle Drain Accessories ii, 6, 51, 72 capacity 92-93 Applied standards ii, 14 connecting drain hose 19 effluent temperature 93 hose 18-19, 59, 65, 72, 93 outlet 20, 48, 59, 93...
Page 126 InnoWave Ultra Sonic Irrigator changing 79 detection 50 inspection 63 Recirculation filter 19, 22, 41, 64, 72, 89 magnet 41, 63 Replacement parts ii, 6, 51, 72 opening 18, 22, 27, 41, 43, 48, 55, 63 Restriction of Hazardous Substances seal 41, 63 (RoHS) 15 Lifting 7...
Page 127 InnoWave Ultra Sonic Irrigator records ii, 8, 111 Transportation ii, 7 Unpacking 18 USB data port 82 Visual symbols ii, 107 Wash cycle abort 10, 47, 57 adding chemical 40, 49, 51 completion 55 downloading onto USB drive 82 errors 57 information on display during cycle 54 outline flow diagram 40 parameters adjusting 45...

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Appendix A: Service Record

Appendix B: Training Records

Appendix C: Decontamination Certificate

Appendix D: Operator and Supervisor Authorization Codes

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