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Steris InnoWave Pro, Operator'S Manual

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Summary of Contents for InnoWave Pro

Page 1: ...InnoWave Pro Sonic Irrigator Operator Manual ENGLISH ...

Page 2: ......

Page 3: ...ION OF THIS MANUAL IN ANY MEDIUM WITHOUT THE EXPRESS PERMISSION OF STERIS IS PROHIBITED 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 ...

Page 4: ...l Symbols updated Added RoHS Requirements 5 30 Nov 2018 Document formatting only 6 12 Feb 2019 Label and manufacturer address update 7 19 Aug 2019 Manufacturer information update 8 15 Oct 2019 Electrical supply update 9 21 May 2020 Manufacturer information update Serious incidents statement added to Introduction Symbols glossary updated Recommended Chemistries updated 10 05 Aug 2020 Document refor...

Page 5: ...ator Training 11 General Information 2 1 Intended Purpose of Equipment 14 2 2 Equipment Features 15 2 3 Equipment Identification 16 2 4 Manufacturer Information 16 2 5 Applied Standards 17 2 6 Compliance 18 2 7 RoHS Requirements 18 2 8 Installation of Equipment 18 2 9 Disposal of Equipment 19 The Touchscreen Display 3 1 The Touchscreen Display 22 3 2 Screen saver Mode on the Display 22 3 3 Enterin...

Page 6: ...ng Baskets from the Carrier 41 5 6 Docking Baskets into the Carrier 42 5 7 The Carrier Light Guard 44 5 7 1 Carrier Light Guard Routine Test 45 5 8 The Carrier Safety Edge 46 5 8 1 Carrier Safety Edge Routine Test 47 Instrument Baskets 6 1 The Function of Instrument Baskets 50 6 2 Basket Selection 51 6 3 Basket Care and Inspection 52 6 3 1 Basket Frame Care 52 6 3 2 Basket Manifolds Care 53 6 3 3 ...

Page 7: ...nd Detaching Hoses 79 6 7 2 Xi Multi Basket Loading 81 6 7 3 Xi Multi Basket Unloading 84 Performing a Wash Cycle 7 1 Cleaning and Inspection Before Every Wash Cycle 88 7 2 Selecting a Wash Program 89 7 3 Docking Baskets into the Carrier semi automated 90 7 4 Wash Cycle Stages 92 7 5 Information on the Display During a Wash Cycle 94 7 6 The LED Lid Status Indicator 96 7 7 On Completion of a Wash C...

Page 8: ... 9 Decontamination for Transportation 123 The Supervisor Menu 10 1 Functions Available Through the Supervisor Menu 126 10 2 Unlocking the Supervisor Menu 127 10 3 Changing the Supervisor PIN 127 10 4 Viewing and Editing Wash Program Parameters 128 10 5 Selecting 12 Hour or 24 Hour Clock Setting 133 10 6 Selecting Metric or US Units for the Display and Cycle Logs 133 10 7 Changing the Language Used...

Page 9: ...Dimensions and Capacity 164 14 6 Si Multi Basket Dimensions and Capacity 164 14 7 Xi and Xi Multi Basket Dimensions and Capacity 165 14 8 Languages 165 14 9 Environmental Performance 165 Terms Definitions and Symbols 15 1 Terms and Definitions 168 15 2 Visual Symbols 177 Appendices Appendix A Service Record 180 Appendix B Training Records 181 Appendix C Decontamination Certificate 183 Appendix D O...

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Page 11: ...rform any maintenance on the equipment Make sure that all personnel understand the contents of this manual This manual contains important information on the proper use and maintenance of this equipment All personnel involved in the operation and or maintenance of this equipment must carefully review and comply with warnings cautions and instructions contained in this manual These instructions are ...

Page 12: ...Equipment owners are encouraged to develop their own safety policies and procedures to enhance and complement these safety precautions Serious incidents that have occurred in relation to this medical device should be reported to the manufacturer and competent authority in the country where the incident occurred WARNING Pinching hazard Pinch points are created during carrier operation l ALWAYS keep...

Page 13: ...air to qualified personnel only It is expected that any person servicing or repairing the equipment will be a competent technician with an understanding of electrical safety and the risks of working with electrical appliances that use water l Before inspecting or replacing any part switch off and lock out or disconnect the electrical supply at an external isolation point Electrical shock can cause...

Page 14: ...emical contact should be displayed prominently near the equipment WARNING Burn hazard Temperatures within the equipment can reach 98 C 208 F during and after operation l Take care when opening the lid at the end of a wash cycle l Allow sufficient time for items to cool before handling cleaning or commencing maintenance procedures l When removing the basket from a full tank of hot water make sure t...

Page 15: ...lothing neck ties or jewelry that could become entangled in moving parts l NEVER reach into the wash tank when the equipment is operating l ALWAYS use the baskets to process instruments WARNING No user serviceable parts 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...

Page 16: ...uments l ALWAYS open box jointed instruments l ALWAYS disassemble instruments that are designed to be taken apart CAUTION When standing at the front of the equipment such as for the docking and removing of baskets or when using the touchscreen display be careful NOT to inadvertently kick or press in the foot plate switch at the base of the machine The foot pedal should only be used for hands free ...

Page 17: ... Have a fully trained service technician diagnose and remedy the situation l Use non abrasive cleaners when cleaning the equipment Follow directions on the container and rub in a back and forth motion in same direction as the surface grain Abrasive cleaners damage stainless steel Cleaner rubbed in circular motion or applied with a wire brush or steel wool will scratch and dull stainless steel l Av...

Page 18: ...d environmental conditions are always followed during the transportation and storage of the equipment IMPORTANT DO NOT hold on to pull or push the Safety Light Guard sender and receiver units on either side of the sonic irrigator If the laser beam is moved out of alignment the equipment CANNOT operate and repair or replacement of the Safety Light Guard may require the equipment to be returned to t...

Page 19: ...shown below IMPORTANT The foot operated load pedal and the tank and drain are vulnerable when lifting equipment Take care NOT to knock or crush them with the pallet or forklift forks as this could result in irreparable damage to the equipment 1 3 2 Storage Markings The markings on the shipping crate stipulate the storage conditions and provide handling information for the equipment SAFETY INFORMAT...

Page 20: ...1 06 bar 50 kPa to 106 kPa Humidity range 30 to 90 relative humidity non condensing 1 4 Independent Monitoring Important Note for the Product Owner It is advised that an independent monitoring system is fitted in accordance with ISO 15883 1 2006 AMD1 2014 Washer disinfectors Part 1 General requirements terms and definitions and tests 10 SAFETY INFORMATION InnoWave Pro Sonic Irrigator Operator Manu...

Page 21: ...s manual l Safety Information on page 1 l General Information on page 13 l The Touchscreen Display on page 21 l Preparing Chemicals on page 25 l The Carrier on page 35 l Instrument Baskets on page 49 l Performing a Wash Cycle on page 87 l Maintenance on page 109 l Troubleshooting on page 141 Training should be reviewed regularly and training records kept for all operators A form that can be used f...

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Page 23: ...1 Intended Purpose of Equipment 14 2 2 Equipment Features 15 2 3 Equipment Identification 16 2 4 Manufacturer Information 16 2 5 Applied Standards 17 2 6 Compliance 18 2 7 RoHS Requirements 18 2 8 Installation of Equipment 18 2 9 Disposal of Equipment 19 CHAPTER 2 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 24: ...s hollow instruments only of items placed in the tank IMPORTANT If this equipment is used in a manner NOT specified by manufacturer effectiveness and protection provided by equipment may be impaired IMPORTANT This equipment has been validated for the cleaning and intermediate level thermal disinfection of surgical instruments and devices including complex lumen cannulated surgical instrument and r...

Page 25: ...hscreen display Flush ports on baskets provide lumen flushing for cannulated instruments Rotating spray arms above each basket provide deluge wash over instruments Basket and hose sets for Si and Xi robotic instruments provide quick connection to flush ports The sonic irrigator is shipped with three locked programs for instrument processing An additional three unlocked programs can be setup and pa...

Page 26: ...ffaly R35 X865 Ireland 01 05060247263939 11 200212 21 01191234500 208VAC 3P PE 60Hz 18kW InnoWave Pro SN REF MD UDI LISTED C US LABORATORY EQUIPMENT E488885 41DN B C D E A F 2797 Figure 2 1 Example of label attached to the equipment A Model name B Manufacturer s catalog reference model part number C Manufacturer s unique equipment serial number D Electrical power requirement for equipment E Date of...

Page 27: ...ments terms and definitions and tests ISO 15883 2 2006 Washer disinfectors Part 2 Requirements and tests for washer disinfectors employing thermal disinfection for surgical instruments anesthetic equipment bowls dishes receivers utensils glassware etc ISO 17664 2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical device...

Page 28: ...Table 2 1 Applied Standards continued 2 6 Compliance This equipment has been designed to perform within the guidelines recommended by international decontamination standards A stringent quality control program ensures that every machine is manufactured and tested under controlled conditions to ensure that all products perform identically 2 7 RoHS Requirements The equipment manufacturer is committe...

Page 29: ... of the WEEE Directive 2012 16 EU Waste Electrical and Electronic Equipment and is registered with the B2B Compliance Scheme Waste electrical and electronic products must not be placed in the general refuse but collected separately Separately collected WEEE products are to be sent to an approved recycling or disposal operators for safe recycling recovery or reuse GENERAL INFORMATION 19 InnoWave Pr...

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Page 31: ... describes the use of the touchscreen display 3 1 The Touchscreen Display 22 3 2 Screen saver Mode on the Display 22 3 3 Entering an Operator PIN if enabled 22 3 4 Menu Navigation 23 3 5 Main Menu Functions 24 CHAPTER 3 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 32: ...free operation of the carrier 3 2 Screen saver Mode on the Display 1 If the sonic irrigator is inactive for more than 10 minutes the display enters the screen saver mode 2 To exit the screen saver mode touch anywhere on the display 3 3 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 ...

Page 33: ...ction Any operator choices are usually shown at the bottom of the display To return to the main menu from any sub menu touch the return symbol at the top left of the display Table 3 1 Main Menu Symbols Key A Touch to return to the main menu from any sub menu B Touch to scroll left C Current selection D Touch to scroll right E Operator option s Touch on the desired option to proceed THE TOUCHSCREEN...

Page 34: ... Prime Chemical Pump 2 Prime chemical pump 2 Ensures chemical hoses are purged of air after changing chemical bottle Clock Adjust the time and date settings used by the equipment for the display and data logging Supervisor menu Authorized access for supervisors to change the language setting and change the Supervisor PIN Data logging Download the wash cycle logs onto an external USB flash drive In...

Page 35: ... chemicals with the sonic irrigator 4 1 Use of Chemicals 26 4 2 Recommended Chemicals North America Only 27 4 3 Recommended Chemicals Outside North America 28 4 4 Replacing Chemical Bottles 29 4 5 Priming Chemical Pumps 32 CHAPTER 4 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 36: ...B in the image Detergent is required during the main wash stage of a wash program Lubricant usage can be setup in the supervisor menu and delivered during the disinfection stage of a wash program If lubricant is not required by the wash program a lubricant bottle does not need to be present The quantity of chemical in each tray in the chemical enclosure is monitored through automatically weighing ...

Page 37: ... rinses or liquid germicides including hypochlorites is NOT promoted recommended or endorsed Item number Description 1C2210 Prolystica 2X HP enzymatic automated detergent 2 5 US gal 9 4 L 10308 Hinge Free WR lubricant 4 x 3 8 L 4 x 1 0 US gal 1031T6WR Hinge Free WR lubricant 10 0 L 2 6 US gal Table 4 1 Recommended Chemical for North America Note Certain products may not be available in your area C...

Page 38: ...ription 1C39T6WR 8E Zyme multi enzymatic cleaner 10 0 L 2 6 US gal 1C21T6PE Prolystica HP neutral automated detergent 10 0 L 2 6 US gal 1C22T6PE Prolystica HP enzymatic automated detergent 10 0 L 2 6 US gal 1C38T6EC Prolystica HP multi enzymatic cleaner 10 0 L 2 6 US gal 1C20T6PE Prolystica HP alkaline automated detergent 10 0 L 2 6 US gal 1031T4PE Hinge Free WR lubricant 2 x 5 0 L 2 x 1 3 US gal ...

Page 39: ...ate Personal Protective Equipment PPE whenever handling chemicals or servicing the chemical injection pumps and lines This should include plastic gloves goggles or a full face visor and a disposable plastic apron l Guidelines to be followed in case of emergency caused by chemical contact should be displayed prominently near the equipment 1 Inside the chemical enclosure a detergent bottle is put on...

Page 40: ...e sonic irrigator Push the tab on the port and pull the hose out of the port 4 Rinse the filter on the chemical pickup under running water Make sure any particles or debris are removed and the filter is clean 5 Remove any spillage from the chemical tray and wipe tray with a cloth to remove any residues 30 PREPARING CHEMICALS InnoWave Pro Sonic Irrigator Operator Manual ...

Page 41: ...ake sure the hose reaches the bottom of the bottle 8 Put the chemical bottle into the chemical enclosure Make sure the hose of the chemical pickup is not pinched kinked or looped 9 Close the doors of the chemical enclosure 10 The chemical pumps must now be primed to prevent chemical cross contamination See Priming Chemical Pumps on the next page PREPARING CHEMICALS 31 InnoWave Pro Sonic Irrigator ...

Page 42: ...nged l If a chemical pickup is removed from a chemical bottle for any reason The chemical pickup must be fully inserted in a full chemical bottle before attempting chemical pump priming 4 5 1 Detergent Pump Priming 1 Make sure the detergent pickup is fully inserted into and reaches to the bottom of the detergent bottle 2 On the display from the main menu touch repeatedly on or until the carrier sc...

Page 43: ... from the chemical bottle 7 The detergent pump will operate and then turn off automatically 8 Repeatedly operate the detergent pump until detergent can be seen entering the tank from the detergent delivery port indicated by A in the image The detergent pump is now primed 9 The detergent pump can be turned off at any time by touching once on Prime Chem Pump on the display while the detergent pump i...

Page 44: ...epeatedly on or until the lubricant symbol is centered and Lubricant appears below it 2 Lubricant enters the tank from the lubricant delivery port The lubricant delivery port is on the left side of the tank as indicated by B in the image When lubricant can be seen flowing from the lubricant delivery port the lubricant pump is primed 34 PREPARING CHEMICALS InnoWave Pro Sonic Irrigator Operator Manu...

Page 45: ...ormation on the Display 37 5 3 Raising and Lowering the Carrier Using the Foot Pedal 38 5 4 Raising and Lowering the Carrier Using the Display 39 5 5 Removing Baskets from the Carrier 41 5 6 Docking Baskets into the Carrier 42 5 7 The Carrier Light Guard 44 5 8 The Carrier Safety Edge 46 CHAPTER 5 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 46: ...es carrier movement Carrier movement cannot be enabled during a wash cycle or when the display is the supervisor menu mode The raising and lowering of the carrier can be performed using either the foot pedal or the touchscreen display The carrier has set positions for the removal and docking of each basket When raising or lowering the carrier the carrier can move automatically to a level for the n...

Page 47: ...n Below the graphic a message provides information on the position of the carrier The four symbols at the bottom of the screen can be used to move the carrier The carrier can also be moved using the foot pedal Symbol Function Up continuous Moves carrier up until it reaches the fully open position Up Moves carrier up to next position if in loading unloading sequence Down Moves carrier down to next ...

Page 48: ... the front of the sonic irrigator at floor level and is marked LOAD 2 Tap the foot pedal to enable carrier controls The carrier controls then appear on the display Note Carrier movement cannot be enabled during a wash cycle or when the display is the supervisor menu mode 3 Press and hold the foot pedal to move the carrier If the carrier is in it s lowest position closed it rises up if the carrier ...

Page 49: ...ch points are created during carrier operation l ALWAYS keep hands clear when opening or closing the carrier l In the unlikely event of an uncontrolled fault the emergency stop button can be pushed to cut power to the carrier and other motorized parts CAUTION When standing at the front of the equipment such as for the docking and removing of baskets or when using the touchscreen display be careful...

Page 50: ... that the lid closes may result in a wash cycle commencing immediately If a wash cycle starts prematurely it can be paused and or aborted using the touchscreen display 4 When the carrier controls are enabled by initiating a wash program or on the confirmation of a wash cycle completion the carrier stops at the 3 basket positions for the docking and removal of baskets See Docking Baskets into the C...

Page 51: ...e carrier control symbols appear or tap the LOAD foot pedal once 2 Continuously press either the foot pedal or continuously touch the symbol on the display to move the carrier to a basket position Note When the carrier controls are enabled by initiating a wash program or on the confirmation of a wash cycle completion the carrier stops at the three basket positions for the docking and removal of ba...

Page 52: ...s are created during carrier operation l ALWAYS keep hands clear when opening or closing the carrier l In the unlikely event of an uncontrolled fault the emergency stop button can be pushed to cut power to the carrier and other motorized parts WARNING Hoses and instruments should NEVER extend outside the limits of a basket l ALWAYS make sure that instruments are located correctly in a basket l ALW...

Page 53: ...e Selecting a Wash Program on page 89 The procedure below is provided when baskets are to be put into the sonic irrigator outside of this requirement 1 Make sure carrier movement is enabled Either touch repeatedly on or until the carrier control symbols appear or tap the LOAD foot pedal once 2 Continuously press either the foot pedal or continuously touch the symbol on the display to move the carr...

Page 54: ...nd lowers If an object interrupts the light guard beam the carrier will cease movement and be inoperable until the object is removed from the area The most common source of objects interrupting the light guard beam are instruments that have moved outside a basket or a basket that is not fully docked into the carrier All baskets should be inspected to make sure that they are fully docked and that a...

Page 55: ...ront of the equipment such as for the docking and removing of baskets or when using the touchscreen display be careful NOT to inadvertently kick or press in the foot plate switch at the base of the machine The foot pedal should only be used for hands free operation of the carrier 1 Make sure carrier movement is enabled If not initiating a wash cycle touch repeatedly on or until the carrier control...

Page 56: ...carrier safety edge has been activated The cause of the safety edge activation should be investigated The most common source of activation is an instrument projecting out of a basket or a basket that is not fully docked into the carrier All baskets should be inspected to make sure that they are fully docked and that all instruments are fully contained within the baskets When the cause of the safet...

Page 57: ...e careful NOT to inadvertently kick or press in the foot plate switch at the base of the machine The foot pedal should only be used for hands free operation of the carrier 1 Make sure carrier movement is enabled If not initiating a wash cycle touch repeatedly on or until the carrier control symbols appear at the bottom of the screen Note Carrier controls can also be enabled by a single tap on the ...

Page 58: ...Touch Reset Safety Edge to confirm that the cause of the safety edge trigger has been removed Carrier movement is then re enabled on the display 48 THE CARRIER InnoWave Pro Sonic Irrigator Operator Manual ...

Page 59: ...ets and the unloading of instruments from the baskets on completion of a wash cycle 6 1 The Function of Instrument Baskets 50 6 2 Basket Selection 51 6 3 Basket Care and Inspection 52 6 4 The Standard Basket 54 6 5 The Si Multi Basket 60 6 6 The Xi Basket 73 6 7 The Xi Multi Basket 78 CHAPTER 6 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 60: ...connections to suit a particular type of surgical instrument Baskets are docked into the carrier which is then lowered into the tank Three baskets are docked into the carrier for a wash cycle When the carrier is lowered fully into the tank the basket manifolds are connected to a pump which then delivers irrigation pressure to the basket ports and connected instruments 50 INSTRUMENT BASKETS InnoWav...

Page 61: ...nstruments Cannulated lumened instruments maximum of 20 Maximum load weight of 10 kg Si Multi Basket Si Endowrist instruments Capacity of 8 Si instruments which can include a maximum of 2 Si stapler instruments Xi Basket Xi Endowrist instruments but NOT staplers Capacity of 6 Xi instruments Xi Multi Basket Xi Endowrist instruments Xi Endowrist staplers Capacity of 4 Xi non stapler instruments and ...

Page 62: ...ents Defects and damage to basket manifolds or flush ports can result in poor cleaning performance and alarm conditions resulting in a wash cycle abort 6 3 1 Basket Frame Care Baskets are designed to fit exactly within the carrier Avoid stacking baskets or placing any weight on them that may distort the basket or twist the frame out of shape When docking baskets into the carrier each basket should...

Page 63: ...asket Flush Ports Care Basket flush ports should always be treated with care Avoid impacting the flush ports when loading and unloading instruments and at all other times Only use luer hoses and nozzles that are compatible with the basket type When attaching or detaching a luer hose or nozzle do not use excessive force to push or pull the connector Do not poke anything into a flush port or use any...

Page 64: ...uments l Cannulated lumened instruments The standard basket can be loaded with a mix of general and cannulated instruments It is recommended that general instruments are loaded first and cannulated instruments are connected after general instrument loading IMPORTANT The standard basket should NOT be used in combination with other basket types when a minimum irrigation pressure is required by the w...

Page 65: ...face non cannulated such as clamps scissors and forceps can be placed directly into a standard basket 1 Open mechanical instruments such as scissors and clamps 2 Place instruments in the baskets distributing evenly Make sure instruments DO NOT protrude through the basket or above the top of a basket 3 Any small instruments that may fall through the basket should be first placed inside a mesh tray ...

Page 66: ...flush ports to receive flushing during wash cycle A luer hose and a suitable sized distal connector will be required to attach each instrument to a basket flush port If loading an assortment of general and cannulated instruments into a basket for processing at the same time it is recommended to load all general instruments before loading cannulated instruments See Standard Basket Loading General I...

Page 67: ...e distal connector silicone opening 5 Pick up a luer hose Push the blue luer lock onto the distal connector and turn clockwise until firmly attached 6 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 7 Attach the luer hose to a basket flush port Always atta...

Page 68: ...in an instrument that may NOT have been cleaned or disinfected satisfactorily Any instruments where a hose or connector may have detached should be reprocessed For any cannulated lumened instruments it is recommended luer hoses and connectors are removed one at a time and inspected before accepting an instrument as processed 1 Before unloading instruments visually inspect the loaded basket If any ...

Page 69: ...s Discard the luer hose if in any doubt about it s condition Instrument will require reprocessing 4 Pull the instrument out of the distal connector If the distal connector silicone opening is damaged discard the distal connector Instrument will require reprocessing INSTRUMENT BASKETS 59 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 70: ...ozzle A nozzle with one outlet as indicated by A in the image above is intended for use with Si stapler instruments only A nozzle with two outlets as indicated by B in the image above is intended for use with Si Endowrist instruments with two body flush ports which excludes Si stapler instruments Nozzles are connected to basket flush ports before instrument loading Up to two stapler instruments ca...

Page 71: ...utlet nozzle indicated by A below For all other Si instruments use a dual port nozzle indicated by B below 3 To connect a nozzle push the nozzle into the basket port until a click is heard and the nozzle is held firmly in place by the securing clip 4 Make sure a connected nozzle is fully inserted There should be NO visible gap between the nozzle shaft and the basket flush port If a gap is visible ...

Page 72: ...LWAYS open box jointed instruments l ALWAYS disassemble instruments that are designed to be taken apart This procedure describes the loading of Si instruments that do not require attachment of an adapter to a shaft flush port For Si instruments with a shaft flush port see Si Multi Basket Loading Instruments with Shaft Flush Port on page 64 and for Si stapler instruments see Si Multi Basket Loading...

Page 73: ...an angle inside the basket 5 Push the body of the instrument onto the nozzle making sure that the nozzle enters the two body flush ports 6 The instrument is now loaded Repeat the procedure for instrument loading for up to eight instruments Note that the bodies of instruments on the opposite side of the basket face the opposite way INSTRUMENT BASKETS 63 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 74: ...ken apart Instruments with a flush port on the shaft just below the body may require this flush port to be connected to equipment flushing for cleaning and disinfection The instrument will require connection to a single site adapter at the shaft flush port before loading into the basket 1 The instrument tip should be open to allow for cleaning of all surfaces 2 Single site adapters and stapler flu...

Page 75: ...instrument Align the adapter nozzle with the port and turn the hose clockwise to clamp onto the shaft 5 Feed the shaft of the instrument through a circular cut out in the basket support 6 Place the housing end of the shaft into an aligned slot in the other basket support NEVER place instruments at an angle inside the basket INSTRUMENT BASKETS 65 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 76: ...t until it clicks into position Tug the hose gently to make sure the connection is secure Make sure that the adapter hose is NOT kinked or constricted 9 The instrument is now loaded Repeat the procedure for instrument loading for up to eight instruments Note that the bodies of instruments on the opposite side of the basket face the opposite way 66 INSTRUMENT BASKETS InnoWave Pro Sonic Irrigator Op...

Page 77: ...stapler instruments only For loading of other types of Si instruments see Si Multi Basket Loading Instruments with Shaft Flush Port on page 64 and Si Multi Basket Loading Instruments without Adapters on page 62 1 The basket should be already be fitted with nozzles See Si Multi Basket Attaching and Detaching Nozzles on page 61 2 The instrument tip should be open to allow for cleaning of all surface...

Page 78: ...the port and turn the hose clockwise to clamp onto the shaft 7 Stapler instruments can ONLY be accommodated in two positions within the Si Multi basket Only load stapler instruments into the two outermost positions of the basket as shown below 8 Feed the shaft of the instrument through a circular cut out in the basket support 68 INSTRUMENT BASKETS InnoWave Pro Sonic Irrigator Operator Manual ...

Page 79: ...h port 1 11 Attach the stapler flush adapter to a upward facing basket flush port Push the connecter into the port until it clicks into position Tug the hose gently to make sure the connection is secure Make sure that the adapter hose is NOT kinked or constricted 12 The instrument is now loaded Repeat the procedure for instrument loading for up to two Si stapler instruments INSTRUMENT BASKETS 69 I...

Page 80: ...the instrument shaft or a basket manifold An instrument detached from a nozzle or an adapter may NOT been cleaned or disinfected satisfactorily Any instruments that may have detached from a hose or nozzle should be reprocessed 1 Pull the instrument body off of the nozzle 2 Lift the body of the instrument up above the basket then pull the instrument shaft out of the basket support 70 INSTRUMENT BAS...

Page 81: ... from a nozzle or an adapter may NOT been cleaned or disinfected satisfactorily Any instruments that may have detached from a hose or nozzle should be reprocessed 1 Push the release tab on the basket flush port to release the adapter hose Pull the hose to disconnect it from the basket flush port 2 Pull the instrument body off of the nozzle 3 Lift the body of the instrument up above the basket then...

Page 82: ...nstrument out of the adapter 5 Inspect any adapter removed in previous step for ruptures or blockages in the hose Discard the adapter if in any doubt about the condition of the hose Instrument will require reprocessing 72 INSTRUMENT BASKETS InnoWave Pro Sonic Irrigator Operator Manual ...

Page 83: ...i Multi basket See The Xi Multi Basket on page 78 6 6 1 Xi Basket Attaching and Detaching Hoses The Xi Basket is supplied with a set of hoses designed to provide quick connection to instruments ONLY the hose set supplied with the Xi Basket should be used Other hoses are NOT recommended 1 Hoses are color coded Only attach a hose to a port of the corresponding color 2 To attach a hose to a port push...

Page 84: ...p tab until the hose connector is released then pull the hose connector out of the port 5 Hose can be left attached to the basket in between instrument unloading and loading The hoses should be inspected regularly and should be replaced whenever there are signs of distortion or rupturing 74 INSTRUMENT BASKETS InnoWave Pro Sonic Irrigator Operator Manual ...

Page 85: ...en apart 1 The instrument tips should be open to allow for cleaning of all surfaces 2 Inspect basket hoses before loading Make sure all hoses and connectors are in good condition If any hose is showing signs of kink or damage it should be replaced 3 Holding the instrument with the body flush ports facing up place it into aligned slots in the basket support The body of the instrument should line up...

Page 86: ... instrument body ports 7 The instrument is now loaded Repeat the procedure for instrument loading until up to a total of six Xi instruments are loaded Note the arrangement of hoses in the image below Use the longer hoses marked with blue or green for the two positions furthest from the basket manifolds only DO NOT use the longer hoses in other positions as this may interfere with basket loading an...

Page 87: ...om baskets before docking into the carrier l ONLY use the hoses and connectors supplied with a basket type and DO NOT mix and use hoses from other baskets 6 6 3 Xi Basket Unloading IMPORTANT Before unloading instruments inspect the basket for any connectors that may have detached from instruments A detached connector during the wash cycle can result in an instrument that may NOT have been cleaned ...

Page 88: ...instrument up and away from the basket 5 Repeat the procedure above to remove all instruments from the basket 6 7 The Xi Multi Basket The Xi Multi Basket is designed for use ONLY with da Vinci EndoWrist Xi robotic instruments NO other types of instruments should be used with this basket The basket total capacity is four Xi non stapler instruments and two Xi stapler instruments 78 INSTRUMENT BASKET...

Page 89: ... Basket should be used Other hoses are NOT recommended 1 Hoses are color coded Only attach a hose to a port of the corresponding color 2 To attach a hose to a port push the hose into the port until the retaining clip clicks into place 3 When the hose is correctly attached there should be NO gap between the hose connector and the port INSTRUMENT BASKETS 79 InnoWave Pro Sonic Irrigator Operator Manu...

Page 90: ...ll the hose connector out of the port 5 Hose can be left attached to the basket in between instrument unloading and loading The hoses should be inspected regularly and should be replaced whenever there are signs of distortion or rupturing 80 INSTRUMENT BASKETS InnoWave Pro Sonic Irrigator Operator Manual ...

Page 91: ...truments that are designed to be taken apart 1 The instrument tips should be open to allow for cleaning of all surfaces 2 Inspect basket hoses before loading Make sure all hoses and connectors are in good condition If any hose is showing signs of kink or damage it should be replaced 3 ONLY Xi stapler instruments can be accommodated in the front two support positions of the basket shown in the imag...

Page 92: ...NEVER attempt to place the instrument at an angle across the basket 6 Push the instrument body down as far as it will go and then push it on to the securing lugs until held in place A gentle tug on the instrument body will confirm that it is attached to the lugs NEVER place the instrument body loosely between lugs 7 Push the hose connector into the instrument body ports 82 INSTRUMENT BASKETS InnoW...

Page 93: ...OT connected to an instrument MUST be removed before docking the baskets in the carrier To detach a hose from a port push the retaining clip tab until the hose connector is released then pull the hose connector out of the port WARNING Hoses and instruments should NEVER extend outside the limits of a basket l ALWAYS make sure that instruments are located correctly in a basket l ALWAYS remove all un...

Page 94: ... disinfected satisfactorily Any instruments where a connector may have detached should be reprocessed 1 Pull the hose connector out of the instrument body 2 Inspect the luer hose for ruptures Discard the hose if in any doubt about it s condition Instrument will require reprocessing 3 Squeeze both release buttons on the body of the instrument then pull the body away from the basket lugs 84 INSTRUME...

Page 95: ...4 Pull the instrument up and away from the basket 5 Repeat the procedure above to remove all instruments from the basket INSTRUMENT BASKETS 85 InnoWave Pro Sonic Irrigator Operator Manual ...

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Page 97: ...nd instruments loaded as described in Instrument Baskets on page 49 7 1 Cleaning and Inspection Before Every Wash Cycle 88 7 2 Selecting a Wash Program 89 7 3 Docking Baskets into the Carrier semi automated 90 7 4 Wash Cycle Stages 92 7 5 Information on the Display During a Wash Cycle 94 7 6 The LED Lid Status Indicator 96 7 7 On Completion of a Wash Cycle 97 7 8 Pausing or Aborting a Wash Cycle 9...

Page 98: ...servicing the chemical injection pumps and lines This should include plastic gloves goggles or a full face visor and a disposable plastic apron l Guidelines to be followed in case of emergency caused by chemical contact should be displayed prominently near the equipment The following cleaning should ALWAYS be performed before every wash cycle UNLESS the tank fluids have been retained using the rew...

Page 99: ...tently kick or press in the foot plate switch at the base of the machine The foot pedal should only be used for hands free operation of the carrier IMPORTANT If instruments are to be processed in a disinfection wash cycle they should first be prepared by either a Cleaning in a wash cycle using the sonic irrigator b Manually cleaning under running water with a soft nylon brush paying particular att...

Page 100: ...cle through wash programs until the desired wash program appears on the display below the wash program symbol For details of available wash programs see Wash Programs on page 155 7 3 Docking Baskets into the Carrier semi automated 1 Visually confirm that the wash program shown on the display is the one required for the processing of instruments and that it is suitable for the basket type and baske...

Page 101: ... basket into the carrier 4 The basket MUST be inserted fully into the carrier Push the basket until the front of the basket is level with the carrier 5 With the basket fully pushed into the carrier push up on the two basket catches on the carrier until BOTH catches engage and BOTH ball levers drop The basket is now docked in the carrier PERFORMING A WASH CYCLE 91 InnoWave Pro Sonic Irrigator Opera...

Page 102: ...ough 5 above to dock a basket in to the top carrier position 9 Continuously press either the foot pedal or continuously touch the symbol on the display to move the carrier to the fully closed position When the sonic irrigator detects that the carrier is lowered fully and that the lid is closed the wash cycle will start automatically 7 4 Wash Cycle Stages The stages of the Standard Disinfect Cycle ...

Page 103: ...lternating ultrasonics and lumen flushing Draining Water drains from tank Rinsing 2 times Filling Tank fills to minimum level from cold water inlet Spraying Flushing Alternating spraying and lumen flushing Draining Water drains from tank Disinfection Filling Tank fills to min level from hot or RO water inlet Spraying Flushing Alternating spraying and lumen flushing Draining Water drains from tank ...

Page 104: ...ure of fluids water and chemical mix in the tank D Water heater orange when heating gray when off E Shows either the time elapsed or the time remaining for the current stage F Pressure of washing fluids at flush ports G Current action within the stage of the wash cycle H Progress bar and name of wash program 94 PERFORMING A WASH CYCLE InnoWave Pro Sonic Irrigator Operator Manual ...

Page 105: ...indicates that nozzles in lid are operating spraying cleaning fluids down over instruments in basket Additionally Spraying is shown as the current action on display see G on Figure 7 1 When shown indicates that circulation pump is operating pushing cleaning fluids through basket manifold and any instruments connected to flush ports Additionally Flushing is shown as the current action on display se...

Page 106: ...s and activity of the equipment Color Mode Meaning Blue Panning Resetting Static Idle Pulsing Cycle Running Green Flashing Cycle End Static Cycle Completed Red Flashing Cycle Halted Static Error Panning Carrier Lift Moving Orange Flashing Attention Required Table 7 2 LED Lid Status Indicator Key 96 PERFORMING A WASH CYCLE InnoWave Pro Sonic Irrigator Operator Manual ...

Page 107: ...cribes the operator actions necessary on the completion of a normal wash cycle such as set in program 1 Standard Disinfect Cycle This procedure does NOT apply for the completion of rewash cycles which is described in On Completion of a Rewash Cycle on page 105 1 At end of a wash cycle a chime is emitted and the Cycle Complete screen appears on the display 2 Touch Unload on the display to confirm t...

Page 108: ... WARNING l ALWAYS wear appropriate Personal Protective Equipment PPE whenever removing baskets from the carrier and tank l In instances of body contact with chemical ALWAYS follow emergency procedure given in that chemical s SDS or call emergency services 4 Push the two metal spherical catch levers up on either side of the carrier until the basket catches drop forwards and the basket is released 5...

Page 109: ...le if required NOTE The emergency stop button is intended for emergency situations only and is NOT intended for pausing or aborting a wash cycle in normal operation ALWAYS use the touchscreen display to operate the equipment in normal operation and for pausing or aborting a wash cycle 1 During the wash cycle touch the pause symbol located at the top left of the display The wash cycle is immediatel...

Page 110: ...error occurs during wash cycle load may be contaminated and require reprocessing Review cycle log to establish if wash cycle completed before error If error interrupted wash cycle repeat cycle to reprocess load If error persists use another unit or alternative cleaning process according to facility procedure and contact equipment supplier to have unit serviced 1 When an error occurs an audible ala...

Page 111: ...tank will empty automatically The sonic irrigator will then reset and the display returns to the main menu 5 Instruments must be reprocessed if the error occurred during the wash cycle PERFORMING A WASH CYCLE 101 InnoWave Pro Sonic Irrigator Operator Manual ...

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Page 113: ...apter describes the rewash feature which may only be available on certain equipment configurations 8 1 Rewash Program Setting 104 8 2 The Rewash Counter 104 8 3 On Completion of a Rewash Cycle 105 CHAPTER 8 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 114: ...s only On completion of a rewash cycle it is strongly recommended that instruments are further processed in a standard wash cycle to rinse off any remaining soil and chemicals WARNING If setting up a rewash program for use with instruments contaminated with blood it is recommended that the wash temperature is set no higher than 35 ºC 95 ºF High temperature washes without a pre wash cycle can leave...

Page 115: ...tive Equipment PPE whenever removing baskets from the carrier and tank l In instances of body contact with chemical ALWAYS follow emergency procedure given in that chemical s SDS or call emergency services 1 At end of a rewash cycle the WASH END screen appears on the display 2 To reuse the tank fluids and perform another rewash cycle touch Yes on the display If the tank fluids are not to be reused...

Page 116: ...ith chemical ALWAYS follow emergency procedure given in that chemical s SDS or call emergency services 5 Push the two metal spherical catch levers up on either side of the carrier until the basket catches drop forwards and the basket is released 6 With both hands pull the basket out of the carrier Move the baskets to a draining and unloading area away from the sonic irrigator 7 Repeat the steps 3 ...

Page 117: ...he loaded baskets one by one into the carrier See Docking Baskets into the Carrier semi automated on page 90 12 Lower the carrier fully until closed 13 Touch Reload Complete on the display to confirm the loading of instruments 14 The next rewash cycle starts immediately THE REWASH FEATURE 107 InnoWave Pro Sonic Irrigator Operator Manual ...

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Page 119: ...d Inspection 111 9 3 Weekly Cleaning and Inspection 116 9 4 Checking the Time and Date Settings 117 9 5 Performing a Weekly Full Decontamination 118 9 6 Performing a Full Decontamination After Standing Idle 119 9 7 Accessories and Replacement Parts 121 9 8 Equipment Servicing 122 9 9 Decontamination for Transportation 123 CHAPTER 9 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 120: ...0 lux 46 5 foot candle CAUTION Follow recommended safety precautions for cleaning products in use CAUTION It is recommended that Personal Protection Equipment PPE is worn during loading unloading and cleaning or decontaminating of equipment This must include apron gloves and eye protection CAUTION Use non abrasive cleaners for cleaning internal and external surfaces of the equipment Follow directi...

Page 121: ...r their frequency and manner of use WARNING Pinching hazard Pinch points are created during carrier operation l ALWAYS keep hands clear when opening or closing the carrier l In the unlikely event of an uncontrolled fault the emergency stop button can be pushed to cut power to the carrier and other motorized parts WARNING l ALWAYS wear appropriate Personal Protective Equipment PPE whenever removing...

Page 122: ... them Make sure that ALL basket flush ports are undamaged and free of blockages or debris See Basket Care and Inspection on page 52 5 On the carrier remove spray arms one at a time and make sure that there are NO debris or deposits blocking passages or spray holes 5 1 To remove each spray arm push the arm firmly into the rotor housing and turn the arm counter clockwise The arm can then be pulled o...

Page 123: ...l resistance is felt 5 4 Make sure that holes in spray arm point DOWNWARDS If holes in arm point upwards the arm MUST be removed and refitted 6 Make sure that ALL spray arms are firmly attached to rotors and that each rotor turns freely 7 Inspect the 4 docking ports on the underside of the carrier lid Make sure that the ports are in a good condition and that there are NO signs of splitting or dama...

Page 124: ...eposits on the ports 9 With a clean cloth and disinfectant cleaner wipe all internal surfaces of the tank 10 With a clean cloth and disinfectant cleaner wipe all surfaces of the carrier Pay particular attention to the lid seal 11 With a clean cloth and disinfectant cleaner wipe all external surfaces 114 MAINTENANCE InnoWave Pro Sonic Irrigator Operator Manual ...

Page 125: ...sinfectant cleaner from internal and external surfaces of the equipment and the carrier 13 Cleaning performance should be tested each day the equipment is used and all test results recorded MAINTENANCE 115 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 126: ... cleaning and inspection See Daily Cleaning and Inspection on page 111 2 Make sure that the mains power cable is not trapped or damaged 3 Inspect all drainage connections and hoses for leaks kinks or damage 4 Make sure that the carrier and carrier safety systems are fully functional 4 1 Raise and lower the carrier fully See Raising and Lowering the Carrier Using the Display on page 39 and Raising ...

Page 127: ... the clock symbol The touchscreen buttons below the current time and date are used to adjust settings 9 4 1 Time Setting Adjustment 1 On the display within the main menu touch or repeatedly until the clock symbol is centered and the time and date appear below it 2 Touch Set Time at the bottom of the display 3 On the Set Time screen touch and to adjust hours minutes seconds settings as required 4 T...

Page 128: ...er operation l ALWAYS keep hands clear when opening or closing the carrier l In the unlikely event of an uncontrolled fault the emergency stop button can be pushed to cut power to the carrier and other motorized parts WARNING l ALWAYS wear appropriate Personal Protective Equipment PPE whenever removing baskets from the carrier and tank l In instances of body contact with chemical ALWAYS follow eme...

Page 129: ...re created during carrier operation l ALWAYS keep hands clear when opening or closing the carrier l In the unlikely event of an uncontrolled fault the emergency stop button can be pushed to cut power to the carrier and other motorized parts WARNING l ALWAYS wear appropriate Personal Protective Equipment PPE whenever removing baskets from the carrier and tank l In instances of body contact with che...

Page 130: ...safely accommodated this way Disinfection solution Volume for tank 5 of non foaming Sodium Hypochlorite 5 is equivalent to 8250 ml 279 0 fl oz 3 Select and perform Program 6 Decontamination Alternatively a custom decontamination program can be defined using the supervisor menu if required 4 With 30 seconds of the prewash stage remaining press to pause the cycle 5 Wait 15 minutes then touch Resume ...

Page 131: ...emicals accessories and replacement parts may cause damage to the equipment and could void both your warranty and guarantee of performance 9 7 1 Accessories Item number Description MP21852 Standard Basket and hose set MP21846 Standard hose and luer pack of 20 MP21907 Si Multi Basket and hose set MP22168 Si Multi hoses luers and nozzles set MP22036 Xi Basket and hose set MP21906 Xi Multi Basket and...

Page 132: ...nd repair should ONLY be performed by service technicians approved by the equipment manufacturer It is recommended that this equipment is serviced every 6 months Servicing should only be performed by a supplier approved service technician STERIS and it s distributors offer a range of service contracts and extended warranty packages to provide continuous maintenance and breakdown cover once the ori...

Page 133: ...gator is fully decontaminated before any actions to move or transport the equipment The procedures for decontamination are described in Performing a Weekly Full Decontamination on page 118 and Performing a Full Decontamination After Standing Idle on page 119 If preparing the equipment for shipping to the supplier or a suppliers agent fill out a Decontamination Certificate See Decontamination Certi...

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Page 135: ...10 2 Unlocking the Supervisor Menu 127 10 3 Changing the Supervisor PIN 127 10 4 Viewing and Editing Wash Program Parameters 128 10 5 Selecting 12 Hour or 24 Hour Clock Setting 133 10 6 Selecting Metric or US Units for the Display and Cycle Logs 133 10 7 Changing the Language Used by the Display 134 CHAPTER 10 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 136: ...y the display and cycle records Symbol Name Function Enter New PIN Change the supervisor PIN View Edit Wash program View or edit if unlocked wash program parameters Measurements 12 24 hr clock Set internal clock to 12 hour or 24 hour format Measurements temperature Set temperature units to either Celsius or Fahrenheit Measurements fluid volume Set fluid volume units to either milliliters or US flu...

Page 137: ...des on page 185 10 3 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 1 Unlock the Supervisor Menu using the supervisor PIN See Unlocking the Supervisor Menu above 2 Within t...

Page 138: ...the supervisor PIN is changed and the display will return to Enter New Pin 10 4 Viewing and Editing Wash Program Parameters Within the supervisor menu wash program parameters can be viewed If a wash program is unlocked the program parameters can also be adjusted using the display Locked wash programs can only be viewed and not adjusted If a wash program is unlocked the text at the bottom of the di...

Page 139: ...nlocked wash program parameters 4 When viewing wash program parameters touch to move to the next screen or touch to go back to the previous screen If the wash parameters are editable the adjustment symbols and appear under each parameter and can be used to adjust the setting Note A value of 0 C 32 F is interpreted as temperature not important by the equipment The tank will fill with water from the...

Page 140: ...ture Program Name This screen only appears for unlocked wash programs and allows the wash program name to be edited using the on screen keyboard The program name is limited to the display width and a maximum of 30 characters 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 zer...

Page 141: ...he center is the water temperature 0 C to 60 C or 32 F to 140 F On the right is the duration in minutes 0 to 40 Rewash In the center is the number of times the tank fluids will be used for washing 0 to 10 If value is set to zero rewash is not performed and tank fluids are drained after every washing stage Rinsing On the left is the water temperature 0 C to 60 C or 32 F to 140 F In the center is th...

Page 142: ...fection should NOT be assumed It is the responsibility of the equipment owner operator to ensure that time and temperature settings within the disinfection rinse program parameters comply with the level of disinfection expected Drying In the center is the duration of the drying stage in minutes 0 to 20 If the value is set to zero drying is not performed 5 Save Changes If an unlocked wash program h...

Page 143: ...n menu functions 10 6 Selecting Metric or US Units for the Display and Cycle Logs Metric or US imperial units can be selected for temperature fluid volume and water pressure The measurement selection is used by both the display and the recorded cycle logs 1 Unlock the supervisor menu using the supervisor PIN See Unlocking the Supervisor Menu on page 127 2 For temperature touch or repeatedly until ...

Page 144: ...le between bar and psi pounds per square inch for water pressure 8 Touch on the return symbol to exit the supervisor menu and return to equipment main menu functions 10 7 Changing the Language Used by the Display 1 Unlock the supervisor menu using the supervisor PIN See Unlocking the Supervisor Menu on page 127 2 On the display touch or repeatedly until the symbol is centered and Language appears ...

Page 145: ...ages appear in the following sequence English Danish French German Japanese Spanish Swedish Finnish Italian Polish Russian Portuguese Norwegian Lithuanian Latvian 5 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 135 InnoWave Pro Sonic Irrigator Operator Manual ...

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Page 147: ...g 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 CHAPTER 11 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 148: ...inside the chemical enclosure 3 On the display touch or repeatedly until the symbol is centered and Download Logs to USB appears below it 4 All Logs downloads all wash cycles since the sonic irrigator was first used New Logs downloads wash cycles since the last USB download Select either All Logs or New Logs 5 Wait for logs to be copied to the USB flash drive The display will report the number of ...

Page 149: ...ash drive from the equipment 7 Touch OK on the display to return to the main menu 8 Remove the USB flash drive from the data port 9 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 139 InnoWave Pro Sonic Irrigator Operator Manual ...

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Page 151: ... corrective actions If an issue cannot be diagnosed and corrected or a problem occurs which is not described in this manual please contact the supplier WARNING No user serviceable parts 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 manufac...

Page 152: ...ring Chemicals on page 25 Make sure water pressure is not too high See Viewing and Editing Wash Program Parameters on page 128 If problem persists contact supplier to arrange a qualified technician inspection 3 Drain timeout Make sure filter is not clogged See step 2 of Cleaning and Inspection Before Every Wash Cycle on page 88 Make sure instruments are not blocking drain Make sure drain hose is n...

Page 153: ...ction 10 Chamber water level low Make sure that non foaming chemical is being used See Preparing Chemicals on page 25 Check equipment and water connections for leaks If equipment is leaking contact supplier to arrange a qualified technician inspection 11 Chamber water heat rate low Repeat cycle If problem persists contact supplier to arrange a qualified technician inspection 13 Chemical dosing Mak...

Page 154: ...om level sensor invalid Switch the equipment off then on again If problem persists contact supplier to arrange a qualified technician inspection 17 Bottom or minimum level sensor invalid Switch the equipment off then on again If problem persists contact supplier to arrange a qualified technician inspection 18 Minimum level sensor invalid Switch the equipment off then on again If problem persists c...

Page 155: ...re docked correctly See Docking Baskets into the Carrier on page 42 If problem persists contact supplier to arrange a qualified technician inspection 23 Temperature set point exceeded Make sure that the hot water temperature is no more than 80 C 176 F Reduce hot water flow rate at source if too hot Make sure that the cold water flow rate is sufficient Make sure that the wash program does not have ...

Page 156: ...Sonic generator serial comms lost Switch the equipment off then on again If problem persists contact supplier to arrange a qualified technician inspection 44 Sonic cleaning water level low Switch the equipment off then on again If problem persists contact supplier to arrange a qualified technician inspection 45 Lost remote control with sonic module s Switch the equipment off then on again If probl...

Page 157: ...If problem persists contact supplier to arrange a qualified technician inspection 52 Real time clock read error Switch the equipment off then on again If problem persists contact supplier to arrange a qualified technician inspection 53 24V power supply voltage out of range Switch the equipment off then on again If problem persists contact supplier to arrange a qualified technician inspection 54 Ov...

Page 158: ...ing ports on the carrier Make sure that all docking port seals are present and in good condition See Daily Cleaning and Inspection on page 111 Inspect carrier docking ports on underside of lid Make sure that all ports are in good condition and there are no signs of splitting or damage See Daily Cleaning and Inspection on page 111 Repeat cycle If problem persists contact supplier to arrange a quali...

Page 159: ...t for the equipment the internal circuit breaker may have tripped Contact supplier 12 2 1 2 Draining screen shown on unresponsive display l Make sure that the Emergency Stop button is not pushed in Pull Emergency Stop to reset and allow equipment to drain l Turn equipment off and then on at power isolator Wait for sonic irrigator to perform a reset then try again 12 2 1 3 Carrier does not move l M...

Page 160: ...ts that have moved l Make sure that luer hoses and connections have not detached and are not protruding through the basket s preventing unloading Reposition any hoses that appear to have moved l Make sure that the carrier is in the correct position for the basket removal The carrier height can be adjusted using the carrier controls on the display See Raising and Lowering the Carrier Using the Disp...

Page 161: ...er height can be adjusted using the carrier controls on the display See Raising and Lowering the Carrier Using the Display on page 39 12 2 1 7 Water leaking from the lid area l Make sure that all instruments in the basket are lying flat and no instruments are pointing towards the lid l Inspect the lid seal for damage If damaged the seal will need to be replaced by a service technician Contact the ...

Page 162: ... see General Equipment Issues on page 149 12 2 2 1 Check Chemical appears on the display l Make sure that there is sufficient chemical required by the wash program and replace the bottle if there is insufficient chemical l Make sure that the chemical pickup is fully inserted into the chemical bottle l Make sure that the chemical pickup is not kinked or restricted l Touch OK on the display after ma...

Page 163: ... load more than the recommended number of instruments for cleaning See Instrument Baskets on page 49 l Make sure that at least one instrument is connected to each flush manifold on the baskets See Instrument Baskets on page 49 l Make sure that luer hoses are firmly attached to the flush ports and instruments See Instrument Baskets on page 49 l Make sure that luer hoses are not split ruptured or ki...

Page 164: ...and the indicator IFU l Make sure that the chemical dose is as stated in the wash program parameters and the indicator IFU l Make sure that performance is checked using fresh water in the tank l Make sure that equipment performs a factory standard program as described in the wash program parameters and the indicator IFU l If sonic and or cleaning efficacy indicator s do not confirm expected equipm...

Page 165: ... programs that may be setup on a sonic irrigator when shipped 13 1 Wash Program Configuration 156 13 2 Standard Disinfect Cycle Program 157 13 3 Standard Wash Cycle Program 158 13 4 Decontamination Program 159 CHAPTER 13 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 166: ...splay by navigating to the Select Program screen and touching the or buttons to scroll through the preset programs The parameters used by each wash program can be viewed in the supervisor menu See Viewing and Editing Wash Program Parameters on page 128 It is recommended that wash program parameters are viewed on the display before commencing a wash cycle using a particular program The wash program...

Page 167: ...t Cycle Supervisor editable no locked Stage Parameter Factory setting Pre wash Duration 5 minutes Times performed 1 time Degassing Duration 3 minutes Washing Chemical dose 660 ml 22 3 fl oz Temperature 40 C 104 F Duration 12 minutes Rinse Temperature 60 C 32 F Duration 2 minutes Times performed 2 times Disinfection Temperature 91 C 196 F Duration 3 minutes Drying Duration 1 minute WASH PROGRAMS 15...

Page 168: ...ess before processing in a disinfection cycle Program number P2 Program name Standard Wash Cycle Supervisor editable yes Stage Parameter Factory setting Degassing Duration 2 minutes Washing Chemical dose 660 ml 22 3 fl oz Temperature 40 C 104 F Duration 8 minutes Drying Duration 1 minute 158 WASH PROGRAMS InnoWave Pro Sonic Irrigator Operator Manual ...

Page 169: ... approved service technician Program number P6 Program name Decontamination Supervisor editable no locked Stage Parameter Factory setting Prewash Duration 5 minutes Degassing Duration 3 minutes Washing Chemical dose 660 ml 22 3 fl oz Temperature 40 C 104 F Duration 12 minutes Rinse Temperature 60 C 140 F Duration 1 minute Times performed 2 times Disinfection Temperature 91 C 196 F Duration 3 minut...

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Page 171: ...mption 163 14 3 Overall Dimensions and Weight 163 14 4 Tank Dimensions and Capacity 164 14 5 Standard Basket Dimensions and Capacity 164 14 6 Si Multi Basket Dimensions and Capacity 164 14 7 Xi and Xi Multi Basket Dimensions and Capacity 165 14 8 Languages 165 14 9 Environmental Performance 165 CHAPTER 14 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 172: ...n detection 3 basket positions each with 2 rotating spray arms Ultrasonic system 84 piezoelectric transducers typically operating at 38 kHz to 40 kHz dependent on load 40 W power per transducer Pulsed degas auto tune frequency sweep Irrigation system Flush ports on basket producing up to 3 0 bar 43 5 psi at a flow rate of 2 9 liters min 98 1 fl oz min Water temperature monitoring Measurement range...

Page 173: ...water consumption below describes a standard wash cycle with no instruments loaded Cold water Hot water RO Water Total for stage 288 liters 76 0 US gal 247 liters 65 3 US gal 145 liters 38 3 US gal 680 liters 179 6 US gal 14 3 Overall Dimensions and Weight External height carrier closed 1113 mm 43 8 in External height carrier open 1663 mm 65 5 in External width 1260 mm 49 6 in External depth 919 m...

Page 174: ...dard Basket Dimensions and Capacity Internal length 672 mm 26 4 in Internal width 347 mm 13 6 in Internal depth 98 mm 3 8 in Maximum load weight 10 0 kg 22 0 lb Flush port connections 20 14 6 Si Multi Basket Dimensions and Capacity Internal length 657 mm 24 0 in Internal width 347 mm 13 6 in Internal depth 100 mm 5 5 in Maximum load weight 10 0 kg 22 0 lb Flush port connections 8 164 SPECIFICATION...

Page 175: ...Italian Polish Danish Japanese Portuguese Finnish Latvian Russian French Lithuanian Spanish German Norwegian Swedish 14 9 Environmental Performance Altitude range Interior only altitude up to 2000 m 6562 ft Ambient operating temperature range 5 ºC to 40 ºC 41 ºF to 104 ºF Maximum humidity 80 relative humidity for up to 31 ºC 88 ºF decreasing linearly to 50 relative humidity at 40 ºC 104 ºF Noise g...

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Page 177: ...initions and Symbols This chapter details terms and definitions used throughout this manual and symbols which may appear on equipment 15 1 Terms and Definitions 168 15 2 Visual Symbols 177 CHAPTER 15 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 178: ...ent Adapters A hose with a fitting designed to fit into the shaft flush port of robotic instruments for the purpose of instrument flushing during cleaning Additives Chemicals and detergents used with equipment to achieve optimal cleaning performance B Basket A perforated stainless steel deep tray or frame designed to hold or contain instruments during wash operation C Cannulated A thin tube or ves...

Page 179: ...h refers to and is equal in meaning to tank See Tank Chemical A water soluble substance used to assist cleaning during a wash cycle Often refers to the use of detergent Chemical pickup Hose assembly that connects to chemical port at the back of the sonic irrigator and is fed into a chemical bottle The hose assembly provides chemical detergent to the sonic irrigator as demanded by wash settings Che...

Page 180: ...in controlled measure from chemical bottle into tank Distal connector A special connector that attaches to and facilitates flushing through hollow and cannulated instruments Drain Feature of equipment designed to allow waste fluids empty from the tank and into a site waste water facility E Effluent Waste fluids expelled from tank when a draining action is performed F Flush Flushing The action of p...

Page 181: ... LED illuminated strip within the lid that acts as a visual indicator of equipment status and activity Light guard A safety device that detects objects projecting out of the front of the carrier and prevents movement of the carrier until the obstruction is removed Loading Placing and or connecting instruments to be processed within the equipment basket and then putting basket inside tank Locked De...

Page 182: ...struments and or connectors to such instruments M 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 Manifold Normally located in the basket a manifold provides connection to flushing feature of equipment Each manifold will have a set number of luer connection ports N Noz...

Page 183: ...ttings to only authorized operators Equipment can also be setup to require operator identification before any operation Precaution Describes an action or measure taken in advance to avert or minimize the risk of harm to persons and or damage to equipment Prewash A preliminary washing action performed before washing actions to remove less stubborn contaminants from instruments Prime Priming An acti...

Page 184: ...ses This fluid then returns to the tank Recirculating tank fluids are used for flushing of instruments Rewash Washing water is reused for multiple wash cycles as defined within cycle settings setup by operator with supervisor access S Safety edge A safety device that detects downward pressure around the top lip of the tank When an object is detected the carrier movement is disabled until the objec...

Page 185: ...rasonic waves to dislodge contaminants from instrument surfaces and flushing to remove debris from instruments Spray arm A beam with holes that rotates during wash operations spraying fluids over the exterior of instruments in the baskets Spraying A action within the wash cycle when fluids are pushed under pressure through basket nozzles and shower over instruments to assist cleaning Supervisor An...

Page 186: ...articles that may be emitted from a liquid at room temperature or when heated W Warning Advice alerting of a danger that can potentially cause personal injury or death X 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 1...

Page 187: ...ound on equipment Electric Shock Hazard Refer to operator manual for further details on electrical hazards associated with this equipment Electrical Power Requirement of Equipment Refer to operator manual for further information on electrical power and electrical connection requirements for this equipment Hazard Warning Caution Refer to operator manual for further details on hazards associated wit...

Page 188: ...ber 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 Consult Instructions Read manual s shipped with equipment before attempting to install or operate Consult Instructions Read manual s shipped with equipment before attempting to install or operate Directive on Waste Elec...

Page 189: ...ppendices Appendix A Service Record 180 Appendix B Training Records 181 Appendix C Decontamination Certificate 183 Appendix D Operator and Supervisor Authorization Codes 185 InnoWave Pro Sonic Irrigator Operator Manual ...

Page 190: ...es since last service Cycles since last service Next service due Next service due 2 5 Year Service 3 Year Service Serviced by Serviced by Cycles since last service Cycles since last service Next service due Next service due 3 5 Year Service 4 Year Service Serviced by Serviced by Cycles since last service Cycles since last service Next service due Next service due 4 5 Year Service 5 Year Service Se...

Page 191: ...Appendix B Training Records The table below can be used for keeping training records Date Name Title of training Signature of trainer APPENDICES 181 InnoWave Pro Sonic Irrigator Operator Manual ...

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Page 193: ...cate is not visible on outside of shipping crate courier and or supplier CAN REFUSE to accept item s DECONTAMINATION CERTIFICATE I hereby certify that the unit referred to in this document by Model and Serial Number has been disinfected in accordance with hospital procedure Model No Serial No Hospital Name Signature Date Promoting a clean and safe service APPENDICES 183 InnoWave Pro Sonic Irrigato...

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Page 195: ...6 68 8787 9 2848 29 4868 49 6888 69 8828 10 2989 30 4929 50 6949 70 8969 11 3070 31 5090 51 7030 71 9050 12 3171 32 5191 52 7131 72 9151 13 3292 33 5232 53 7252 73 9272 14 3353 34 5373 54 7393 74 9333 15 3434 35 5454 55 7474 75 9494 16 3535 36 5555 56 7575 76 9995 17 3656 37 5676 57 7696 77 9636 18 3797 38 5737 58 7757 78 9777 19 3878 39 5898 59 7838 79 9858 20 3979 40 5999 60 7939 80 9959 Supervi...

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Page 197: ...ntrols UI 37 39 41 45 47 150 docking baskets 42 52 77 90 foot pedal 6 15 22 24 36 39 41 43 45 47 89 90 97 106 149 function 35 36 light guard 44 45 116 149 lowering 38 39 removing baskets 3 41 98 105 111 116 118 119 safety edge 46 47 116 149 162 Chemicals bottles 24 26 33 143 152 163 delivery ports 32 34 detergent 2 15 26 29 32 34 disinfection solution 120 dose 154 157 159 lubricant 15 26 27 29 32 ...

Page 198: ...erated 165 Errors See Troubleshooting F Features of equipment 15 Flushing See Wash cycle H Hose clamps 72 122 I Identification of equipment 16 Inspection See Maintenance Instruments box jointed 6 55 56 62 64 67 75 81 cannulated 15 54 56 care 6 55 56 62 64 67 75 81 general 51 54 56 Si S robotic da Vinci 51 61 62 Xi robotic da Vinci 15 Intended purpose 14 162 Internal data storage 163 Irrigation sys...

Page 199: ...d 2 eye injury hazard 4 29 88 protective equipment PPE 4 8 29 88 slipping hazard 4 Serial number 16 24 139 178 183 Servicing 2 8 29 88 111 122 123 183 record 122 180 schedule 122 Si S robotic da Vinci See Instruments Specification 161 Standards ii 17 18 132 177 Storage See Transportation T Tank dimensions 164 docking ports 113 148 maximum liquid volume 164 Time and Date 12 24 hour clock 126 133 cl...

Page 200: ...tarting 24 Wash programs Decontamination 120 159 parameters editing 128 parameters viewing 128 Standard Disinfect Cycle 92 97 148 156 157 Standard Wash Cycle 104 156 158 163 Water detected level 95 flow rate supply 145 162 heater 94 level sensors 144 pressure supply 10 14 15 46 47 50 53 54 94 126 131 133 142 151 temperature 4 129 145 162 Weight maximum load 51 164 maximum operating 163 X Xi roboti...

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