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Steris InnoWave PCF Sonic Irrigator, Operator'S Manual

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Steris InnoWave PCF Sonic Irrigator Operator'S Manual Download Page 28

Standard

Title

EN 61326-1:2020
BS EN/IEC 61326-1:2021

Electrical equipment for measurement, control and
laboratory use. EMC requirements. General requirements.

IEC 62304:2006+AMD1:2015

Medical device software. Software life-cycle processes.

IEC 62366-
1:2015+AMD1:2020

Medical devices — Part 1: Application of usability
engineering to medical devices.

Table 2.2

Applied Standards (continued)

2.7

Compliance

This equipment has been designed to perform within the guidelines recommended
by international decontamination standards. A stringent quality control program
ensures that every unit is manufactured and tested under controlled conditions to
ensure that all products perform identically.

2.8

RoHS Requirements

The equipment manufacturer is committed to meeting or exceeding the
requirements of the RoHS Directive 2011/65/EU + (EU) 2015/863, "Restriction of
the Use of Certain Hazardous Substances in Electrical and Electronic Equipment".

2.9

Installation of Equipment

This equipment requires installation and commissioning before it can be operated.
In the event of the equipment owner choosing not to have a manufacturer-approved
installer prepare the equipment, installation procedures should be requested from
the supplier or local representative.

2.10

Disposal of Equipment

This equipment

contains materials which

may require

disposal through

appropriately licensed and permitted hazardous waste management firms. The
equipment manufacturer is committed to meeting all requirements 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.

20

GENERAL INFORMATION

InnoWave PCF Sonic Irrigator

Operator Manual

Summary of Contents for InnoWave PCF Sonic Irrigator

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

Page 2: ......

Page 3: ... 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 repair or o...

Page 4: ...ected Supervisor Authorization Code in Appendix D 12 11 Apr 2022 New section on The Touchscreen Display Identifying Features on the Equipment added to General Information Basket Care and Inspection added to Using Instrument Baskets Selecting 12 Hour or 24 Hour Clock Setting Selecting Metric or US Units for the Display and Cycle Logs added to The Supervisor Menu Connecting a Device to the RS232 Por...

Page 5: ...dentifying Features on the Equipment 15 2 4 Equipment Identification 18 2 5 Manufacturer Information 18 2 6 Applied Standards 18 2 7 Compliance 20 2 8 RoHS Requirements 20 2 9 Installation of Equipment 20 2 10 Disposal of Equipment 20 The Touchscreen Display 3 1 Purpose of 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 Navigat...

Page 6: ...Si Multi Basket 47 5 6 1 Si Multi Basket Si Single Site Hose Connection 48 5 6 2 Si Multi Basket Loading Instruments 50 5 6 3 Si Multi Basket Loading Staplers 52 5 6 4 Si Multi Basket Unloading 56 5 7 Xi Multi Basket 58 5 7 1 Xi Multi Basket Loading 58 5 7 2 Xi Multi Basket Unloading 61 5 8 Maxi Rinse Basket 62 5 8 1 Maxi Rinse Basket Loading 63 5 9 Docking the Basket into the Tank 64 Performing a...

Page 7: ...guage Used by the Display 100 The Rewash Feature 9 1 Rewash Program Setting 104 9 2 The Rewash Counter 104 9 3 On Completion of a Rewash Cycle 105 Wash Cycle Logs 10 1 Connecting a Device to the RS232 Port 108 10 1 1 Connecting a Thermal Printer to the RS232 Port 108 10 1 2 Connecting a Data Logging PC to the RS232 Port 109 10 2 Paper Run Out on Printer 109 10 3 Downloading Wash Cycle Logs to a US...

Page 8: ...tion Program 129 Specification 13 1 Performance 132 13 2 Water Consumption 133 13 3 Power Consumption 133 13 4 Overall Dimensions and Weight 134 13 5 Tank Dimensions and Capacity 134 13 6 Standard Basket Dimensions and Capacity 134 13 7 Si Basket Capacity 135 13 8 Si Multi Basket Capacity 135 13 9 Xi Multi Basket Capacity 135 13 10 Maxi Rinse Basket Capacity 136 13 11 Languages 136 13 12 Environme...

Page 9: ...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 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 10: ...haustive 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 Explosion hazard Flammable or combustible materials can cause a fire o...

Page 11: ...aces are dried after every wash cycle l When removing baskets ALWAYS allow fluid to drain into the tank before moving to next cleaning station Excess water spillage may cause electrical shock and serious injury WARNING Chemical burn and or eye injury hazard Chemicals are caustic and can cause adverse effects to exposed tissues l DO NOT get chemicals in eyes on skin or attempt to consume orally l R...

Page 12: ...nstalled moved or relocated by a manufacturer approved service technician or an approved installer l Maintenance performed by unqualified personnel or installation of unauthorized parts could cause personal injury result in improper equipment performance invalidate the warranty or result in serious damage l Scheduled preventive maintenance as described within the service manual is required for saf...

Page 13: ...at the wash temperature is no higher than 35 ºC 95 ºF High temperature washes without a pre wash cycle can leave clotted blood on instruments and can promote formation of prions leading to instrument contamination When performing a succession of rewash cycles repeated sonic activity may increase the tank water temperature and care should be taken to not exceed the recommended limit of 35 ºC 95 ºF ...

Page 14: ...he manufacturer chemical safety data sheet SDS before use and NEVER use toxic corrosive or flammable liquids Other chemicals have to be validated by the equipment owner and proven compatible with the equipment before use l ALWAYS check the expiry date on chemical containers before use l For correct disposal of chemical containers refer to the manufacturer instructions and local regulations CAUTION...

Page 15: ...h chloride content can be harmful to stainless steel l Repeated fuse blows or circuit breaker trips indicate a short circuit or overload 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...

Page 16: ...d as a two person lift and additional assistance sought Alternatively the basket loading should be revised to reduce the weight of the loaded basket CAUTION Instrument care l Always confirm compatibility with instrument manufacturer l Always follow manufacturer instructions if processing instruments with special characteristics e g fiber optics or rigid optics l Always follow manufacturer instruct...

Page 17: ...rking instructions and environmental conditions are always followed during transport and storage of the equipment 1 3 1 Lifting Lifting and maneuvering of the equipment in the shipping crate must be done with a pallet truck or forklift truck able to carry a load in excess of 250 kg 550 lb 1 3 2 Storage Markings Markings on the shipping crate stipulate the equipment storage conditions and handling ...

Page 18: ...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 PCF Sonic Irrigator Operator Manu...

Page 19: ... should cover as a minimum the following sections of this manual l Safety Information on page 1 l General Information on page 13 l Preparing Chemicals on page 25 l Using Instrument Baskets on page 31 l Performing a Wash Cycle on page 67 l Maintenance on page 79 l Troubleshooting on page 113 Training should be reviewed regularly and training records kept for all operators See Training Records on pa...

Page 20: ...12 This page intentionally blank InnoWave PCF Sonic Irrigator Operator Manual ...

Page 21: ...quipment 14 2 2 Equipment Features 14 2 3 Identifying Features on the Equipment 15 2 4 Equipment Identification 18 2 5 Manufacturer Information 18 2 6 Applied Standards 18 2 7 Compliance 20 2 8 RoHS Requirements 20 2 9 Installation of Equipment 20 2 10 Disposal of Equipment 20 CHAPTER 2 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 22: ...nt and robotic surgical instruments Testing to validate cleaning and disinfection efficacy for a specific instrument is the responsibility of the instrument manufacturer Consult the instrument manufacturer s instructions on cleaning and disinfection 2 2 Equipment Features The InnoWave PCF Sonic Irrigator has stand alone sonic irrigation and a total tank volume of 69 liters 18 2 US gal A range of i...

Page 23: ...onnected thermal printer or computer The on board cycle log can be copied to an inserted USB flash drive 2 3 Identifying Features on the Equipment The following illustrations identify locations of important features on the sonic irrigator LID LID HANDLE CASTER x4 TANK LID SEAL DISPLAY ELECTRICAL CABINET CHEMICAL ENCLOSURE LATCH STOP x2 LHS ACCESS PANEL LATCH HANDLE ASSEMBLY x2 Figure 2 1 Front vie...

Page 24: ...OUTLET LID CONNECTOR LID LOCK OVERRIDE Figure 2 2 Rear view SPRAY NOZZLES x8 RO WATER INLET DETERGENT INLET LUBRICANT INLET HOT WATER INLET COLD WATER INLET BASKET GUIDE x4 SIDE BASKET GUIDE x4 BASKET LOCKING ASSEMBLY x2 FLUSH CONNECTOR x4 FILTER Figure 2 3 Opened lid view 16 GENERAL INFORMATION InnoWave PCF Sonic Irrigator Operator Manual ...

Page 25: ...re 2 3 Lid lock override Figure 2 2 Display Figure 2 1 Lid seal Figure 2 1 Drain outlet Figure 2 2 Lubricant inlet Figure 2 3 Electrical cabinet Figure 2 1 Overflow manifold Figure 2 2 Filter Figure 2 3 Rear access panel Figure 2 2 Flush connector x4 Figure 2 3 RO water connector Figure 2 2 Gas spring x2 Figure 2 2 RO water inlet Figure 2 3 Hot water connector Figure 2 2 Side basket guide x4 Figur...

Page 26: ...60Hz 10kW InnoWave PCF SN REF MD UDI LISTED C US LABORATORY EQUIPMENT E488885 41DN B C D E A F 2797 Figure 2 4 Example of label attached to 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 manufacture F Manufacturer name and address 2 5 Manufacturer Information The manu...

Page 27: ... anesthetic equipment bowls dishes receivers utensils glassware etc ISO 20417 2021 Medical devices Information supplied by the manufacturer of medical devices IEC 61010 1 2010 AMD1 2016 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements UL 61010 1 3rd Edition May 11 2012 Revised July 19 2019 Safety requirements for electrical equipme...

Page 28: ...e of Certain Hazardous Substances in Electrical and Electronic Equipment 2 9 Installation of Equipment This equipment requires installation and commissioning before it can be operated In the event of the equipment owner choosing not to have a manufacturer approved installer prepare the equipment installation procedures should be requested from the supplier or local representative 2 10 Disposal of ...

Page 29: ...ribes the use of the touchscreen display 3 1 Purpose of 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 23 CHAPTER 3 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 30: ...een 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 on Operator PIN codes are listed in Operator and Supervisor Authorization Codes on page 155 1 When Enter Pin Number appears use the number pad on the display to enter a valid four digit o...

Page 31: ...ain 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 3 5 Main Menu Functions The main menu provides access to settings for common equipment functions as described inTable 3 2 Main Menu Functions on the next page To return to the main menu from any selec...

Page 32: ...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 Information Show the serial number total wash...

Page 33: ...tergents and lubricants with the sonic irrigator 4 1 Use of Chemicals 26 4 2 Recommended Chemicals North America Only 26 4 3 Recommended Chemicals Outside North America 27 4 4 Replacing Chemical Bottles 27 4 5 Priming Chemical Pumps 29 CHAPTER 4 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 34: ...and replacement parts may cause damage to the equipment and could void both your warranty and guarantee of performance IMPORTANT The use of any type of chemical additives for instrument processing such as strong alkaline detergents pH 12 alcohol rinses or liquid germicides including hypochlorites is NOT promoted recommended or endorsed 4 2 Recommended Chemicals North America Only Item number Descr...

Page 35: ...d tissues l DO NOT get chemicals in eyes on skin or attempt to consume orally l Read and follow the precautions and instructions on the chemical label and in the Safety Data Sheet SDS prior to handling a chemical changing chemical containers or servicing the chemical injection pumps and lines l Wear appropriate Personal Protective Equipment PPE whenever handling chemicals or servicing the chemical...

Page 36: ...ups Replace chemical bottles one at a time 1 Open the door of the chemical enclosure 2 Remove the old or empty chemical bottle from the chemical enclosure 3 Remove the chemical pickup from the old chemical bottle 4 Make sure new the chemical bottle is small enough to fit inside the chemical enclosure and that the door can close fully 5 Remove the cap from the new chemical bottle 6 Put the chemical...

Page 37: ...emical pumps should be primed in the following situations l Before the first wash cycle l Every time a chemical bottle is changed 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 ...

Page 38: ...e turned off at any time by touching once on Prime Chem Pump on the display while the detergent pump is operating 4 5 2 Lubricant Pump Priming The procedure for priming the lubricant pump is very similar to the procedure for priming the detergent pump with two exceptions 1 On the display from the main menu touch repeatedly on or until the lubricant symbol is centered and Lubricant appears below it...

Page 39: ...g of instruments into each basket type 5 1 Basket Selection 32 5 2 Basket Care and Inspection 33 5 3 Removing the Basket from the Tank 35 5 4 Standard Basket 36 5 5 Si Basket 43 5 6 Si Multi Basket 47 5 7 Xi Multi Basket 58 5 8 Maxi Rinse Basket 62 5 9 Docking the Basket into the Tank 64 CHAPTER 5 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 40: ...ht of 20 kg Si Basket Si S Endowrist instruments Capacity of 10 Si instruments but NOT staplers Si Multi Basket Si S Endowrist instruments and staplers Capacity of 10 Si S instruments which can include a maximum of 2 Si S staplers Xi Multi Basket Xi Endowrist instruments and staplers Capacity of 6 Xi X instruments which can include a maximum of 2 Xi X staplers Maxi Rinse Basket Orthopedic sets gen...

Page 41: ...rt 5 2 1 Basket Frame Care Baskets are designed to fit exactly within the tank When not in the tank avoid stacking baskets or placing any weight on them that may distort the basket or twist the frame out of shape When docking a basket into the tank the basket should slide into place smoothly without the need for force Avoid banging the basket into the tank or trying to ram the basket into position...

Page 42: ...ents 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 tool to detach nozzles or hoses If a nozzle or hose cannot be secured with the port retaining clip the connection is compromised and cannot be...

Page 43: ...sh 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 that gloves are suitably rated for thermal protection Alternatively wait until the water temperature is below a safe limit for the PPE used 1 On the sonic irrigator push the lid handle forward and then pull up to open th...

Page 44: ...ack into the tank 5 Move the basket to a draining area away from the sonic irrigator to allow any residual fluid to drain out 5 4 Standard Basket The standard basket has 4 flush manifolds located in each of the 4 corners of basket Each flush manifold has 5 flush ports making up a total of 20 available flush ports The flush ports provide lumen flushing for cannulated instruments 36 USING INSTRUMENT...

Page 45: ...truments MUST NOT exceed 20 kg 44 lb l Instruments should be distributed evenly around the basket l Avoid instruments contacting each other if possible l Place instruments individually into the basket Avoid tipping or dropping multiple instruments from a bin into the basket l Always process instruments in multiple wash cycles rather than load a basket with many instruments contacting each other ev...

Page 46: ...ts below for procedure on attaching luer hoses and distal connectors IMPORTANT The weight of a basket loaded with instruments MUST NOT exceed 20 kg 44 lb Excess instrument load should be set aside for the next processing cycle 5 4 2 Standard Basket Loading Cannulated Instruments CAUTION Basket Loading l The weight of a basket loaded with instruments MUST NOT exceed 20 kg 44 lb l Instruments should...

Page 47: ...at 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 Do not push instrument into a distal connector that is much smaller than the instrument e...

Page 48: ...et Inspect the luer hose Make sure the luer hose has no kinks or ruptures Do not use a damaged hose 6 Push the blue luer lock onto the distal connector and turn clockwise until firmly attached 7 Place the instrument with the distal connector and luer hose into the basket Make sure the instrument does not poke through the basket or point upwards 40 USING INSTRUMENT BASKETS InnoWave PCF Sonic Irriga...

Page 49: ...basket Do not overload the basket 10 It is recommended that at least one luer hose is connected to each flush manifold in the corners of the basket If less than 4 cannulated instruments are being processed it is recommended that a luer hoses connected to a distal connectors are attached to any flush manifolds not being used This aids water circulation and wash performance IMPORTANT The weight of a...

Page 50: ... time and inspected before accepting an instrument as processed 1 Before unloading instruments visually inspect the loaded basket If any luer hose appears constricted cleaning may have been compromised and connected instrument should be reprocessed 2 Push the release tab on the basket flush port to release the luer hose Pull the luer hose to disconnect it from the basket flush port 3 Turn the luer...

Page 51: ...ecifically to process da Vinci Si S EndoWrist robotic instruments The Si Basket can be loaded with up to 10 Si S robotic instruments The Si Basket can only accommodate Si S non stapler instruments Si S stapler instruments cannot be accommodated For Si S stapler instruments the Si Multi Basket should be used See Si Multi Basket on page 47 USING INSTRUMENT BASKETS 43 InnoWave PCF Sonic Irrigator Ope...

Page 52: ...required by instruments before they can be effectively processed in a thermal disinfection wash cycle 1 The instrument tip should be open to allow for cleaning of all surfaces 2 Push the luer hose tail into the main flush port on the instrument body The main flush port is usually marked with a da Vinci flush port symbol and a number 1 3 Feed the shaft of the instrument through a circular cutout in...

Page 53: ... make sure the connection is secure Make sure the luer hose is not kinked or constricted 6 The instrument is now loaded Repeat the procedure for instrument loading up to a maximum of 10 Si S EndoWrist instruments 7 It is recommended to have at least one instrument connected to each flush manifold in each corner of the basket Note If processing less than 4 instruments attach a luer hose to any flus...

Page 54: ...ected satisfactorily Any instruments that may have detached from a hose should be reprocessed 1 Disconnect the luer hose from the instrument 2 Push the release tab on the basket flush port to release the luer hose Pull the luer hose to disconnect it from the basket flush port 3 Inspect the luer hose for ruptures Discard the hose if in any doubt about it s condition Instrument will require reproces...

Page 55: ...asket The Si Multi Basket is designed specifically to process da Vinci Si S EndoWrist robotic instruments and da Vinci Si S stapler instruments The basket can accommodate up to 10 Si robotic instruments which can include up to 6 Si S stapler instruments USING INSTRUMENT BASKETS 47 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 56: ... of instruments l Instruments may require manual cleaning prior to processing in the sonic irrigator such cleaning is outside the scope of this manual l A preparatory wash cycle may be required by instruments before they can be effectively processed in a thermal disinfection wash cycle 1 The instrument tip should be open to allow for cleaning of all surfaces 2 For each instrument with a shaft flus...

Page 57: ...clearance 5 Put the nozzle into the shaft flush port Keeping nozzle in place turn the hose clockwise to tighten the nozzle clamp onto the shaft of instrument up to hand tight Do not over tighten clamp as this will damage the nozzle 6 Now proceed with instruction for connecting the luer hose to the body of the instrument and the loading of instruments into the basket See Si Basket Loading on page 4...

Page 58: ...Push the luer hose tail into the main flush port on the instrument housing The main flush port is normally marked with the da Vinci flush port symbol and a 1 4 Feed the shaft of the instrument through a circular cutout in the basket support 5 Place the housing end of the shaft into an aligned slot in the other basket support Never place the instruments at an angle inside the basket 50 USING INSTRU...

Page 59: ... the luer hose to an available basket flush port Push the luer hose into the flush port until the retaining clip clicks into position Tug gently on the luer hose to make sure the connection is secure Make sure the luer hose is not kinked or constricted 8 Feed the shaft of the instrument through a circular cutout in the basket support USING INSTRUMENT BASKETS 51 InnoWave PCF Sonic Irrigator Operato...

Page 60: ...ose through basket support to prevent it from moving around during the wash cycle 5 6 3 Si Multi Basket Loading Staplers 1 Inspect the basket Make sure all flush ports and manifolds are clean and in a good condition See Basket Care and Inspection on page 33 2 The instrument tip should be open to allow for cleaning of all surfaces 3 Each stapler instrument requires connection to two hoses a stapler...

Page 61: ...e to clamp onto the shaft 6 Push the luer hose tail into the main flush port on the instrument housing The main flush port is usually marked with the da Vinci flush port symbol and a 1 7 For ease of instrument loading it is recommended to start from the middle basket support positions The outer four positions cannot be used for stapler instruments USING INSTRUMENT BASKETS 53 InnoWave PCF Sonic Irr...

Page 62: ...asket 10 Arrange the instrument so that body rests between anti roll pins on the basket support Never rest the instrument body on top of anti roll pins or force instrument body under anti roll pins It may help to pull up the basket handle to allow the instrument body to pass under the handle when arranging staplers in middle basket support slots 54 USING INSTRUMENT BASKETS InnoWave PCF Sonic Irrig...

Page 63: ... for instrument loading for up to a total of 6 Si stapler instruments 13 It is recommended to have at least one instrument connected to each flush manifold in the four corners of the basket If processing less than 4 instruments attach a luer hose to the basket manifolds not being used this aids water circulation Put the luer hose through the basket support to prevent it from moving around during t...

Page 64: ...a connector or adapter may have detached should be reprocessed 1 Disconnect the luer hose from the instrument 2 Push the release tab on the basket flush port to release the luer hose Pull the luer hose to disconnect it from the basket flush port 3 Inspect the luer hose for ruptures Discard the hose if in any doubt about it s condition Instrument will require reprocessing 4 If the instrument is att...

Page 65: ...pler adapter turn the hose counter clockwise to release the hose clamp then pull the instrument out of the hose adapter 7 Inspect any hose adapter removed in previous step for ruptures or blockages Discard the hose or adapter if in any doubt about it s condition Instrument will require reprocessing USING INSTRUMENT BASKETS 57 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 66: ...nts which can include up to 2 Xi stapler instruments 5 7 1 Xi Multi Basket Loading 1 Inspect the basket Make sure all flush ports and manifolds are clean and in a good condition See Basket Care and Inspection on page 33 2 The instrument tips should be open to allow for cleaning of all surfaces 3 Xi staplers can only be accommodated in support slots adjacent to the long sides of the basket as shown...

Page 67: ...asket slots that line up 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 USING INSTRUMENT BASKETS 59 InnoWave PCF Sonic Irrigator Op...

Page 68: ...nnection is secure 9 The instrument is now loaded Repeat the procedure for instrument loading until up to a total of 6 Xi instruments are loaded 10 It is recommended to have at least one instrument connected to each flush manifold each corner of the basket If processing less than 4 instruments attach a luer hose to any manifolds not being used this aids water circulation Put the luer hose through ...

Page 69: ...pter may NOT have been cleaned or disinfected satisfactorily Any instruments where a connector or adapter may have detached should be reprocessed 1 Pull the luer hose tail out of the instrument body 2 Push the retaining clip tab on the basket flush port to release the luer hose Pull the luer hose to disconnect it from the basket flush port 3 Inspect the luer hose for ruptures Discard the hose if i...

Page 70: ...spray nozzles and 1 flush port on each manifold located in the 4 corners of the basket making up a total of 16 spray nozzles and 4 flush ports The spray nozzles provide an intensive deluge wash and maximum penetration of solid non cannulated instruments This basket is particularly suited for orthopedic and heavily soiled instruments 62 USING INSTRUMENT BASKETS InnoWave PCF Sonic Irrigator Operator...

Page 71: ...n the basket weight loading capacity 1 Inspect the basket Make sure all four basket manifolds located in the corners of the basket are clean and in good condition See Basket Care and Inspection on page 33 2 Open or disassemble mechanical instruments as much as possible 3 Place instruments in the basket distributing evenly Make sure instruments do not protrude through the basket or above the top of...

Page 72: ...ked inside the tank before attempting to start a wash cycle Do not perform a wash cycle without a basket It is recommended to always inspect and clean the tank filter and inspect tank docking ports before docking the basket 1 On the sonic irrigator push the lid handle away from you and then pull up on the handle to fully open the lid 2 Grip the filter and pull up firmly to remove it After cleaning...

Page 73: ...e operator it should be treated as a two person lift and additional assistance sought Alternatively the basket loading should be revised to reduce the weight of the loaded basket 5 Lift the basket using both handles Move the basket slowly and be mindful instruments may move or fall through the basket If any instrument starts to protrude through the basket they must be repositioned before attemptin...

Page 74: ...d down and then pull the lid handle towards you to fully close the lid NOTE If the lid handle is pulled towards you before the lid is in the closed position the lid locks will not be able to engage and the lid cannot close properly If that occurs push the lid handle away from you and make sure that the lid is in the closed position before pulling the lid handle towards you 66 USING INSTRUMENT BASK...

Page 75: ...d instruments loaded as described in Using Instrument Baskets on page 31 6 1 Cleaning and Inspection Before Every Wash Cycle 68 6 2 Selecting a Wash Program 69 6 3 Starting a Wash Cycle 70 6 4 Wash Cycle Stages P1 71 6 5 Information on the Display During a Wash Cycle 73 6 6 On Completion of a Wash Cycle 74 6 7 Pausing or Aborting a Wash Cycle 76 6 8 Wash Cycle Errors 76 CHAPTER 6 InnoWave PCF Soni...

Page 76: ... 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 The following cleaning should ALWAYS be performed before every wash cycle UNLESS the tank fluids have been retained using the...

Page 77: ... is empty make sure that there is NO debris or deposits in the tank 6 2 Selecting a Wash Program IMPORTANT l Always consult instrument manufacturer instructions for the processing of instruments l Instruments may require manual cleaning prior to processing in the sonic irrigator such cleaning is outside the scope of this manual l A preparatory wash cycle may be required by instruments before they ...

Page 78: ...the wash program symbol For details of available wash programs see Wash Programs on page 125 6 3 Starting a Wash Cycle 1 From the main menu touch or repeatedly until the symbol is centered and Load Instruments appears at the bottom of the display 2 Confirm that the program name shown on the display matches the desired wash program If the desired program name is not shown see Selecting a Wash Progr...

Page 79: ...d Refer to Wash Programs Default Parameters on page 127 and Viewing and Editing Wash Program Parameters on page 94 for details on the stages of each of the 6 wash programs Loading and Start Select program Operator selects wash program using touchscreen Load basket Operator docks loaded basket into tank Confirm start Operator confirms start Lid lock is engaged Prewash Filling Tank fills to the mini...

Page 80: ...ills to the minimum level from the hot water inlet Heating Water circulates thru lumens and is heated to point set Spraying and Flushing Spraying and lumen flushing at the same time Draining Water drains from tank Draining and Cooling Cooling Cold water cascades down the back wall of tank and exits without contacting instruments Cooling repeated until tank temperature falls below set limit Cycle c...

Page 81: ...ff E Shows either time elapsed or time remaining for current action or stage F Circulating pump water pressure G Current action within the stage of wash cycle H Progress bar and name of wash program Additional icons in the center of the display provide additional information on the specific activity being performed within the wash cycle stage see Table 6 2 Wash Activity Symbols on the next page PE...

Page 82: ... 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 see G Example of the display during a wash cycle on the previous page When shown indicates that ultrasonic transducers are operating When ultrasonic transducers are operating to remove gases in washing water...

Page 83: ...ning or commencing maintenance procedures l When removing the basket from a full tank of hot water make sure that gloves are suitably rated for thermal protection Alternatively wait until the water temperature is below a safe limit for the PPE used 4 Remove the basket from the tank See Removing the Basket from the Tank on page 35 5 Remove instruments from the basket See the section on Using Instru...

Page 84: ...wash cycle has aborted 4 Touch OK on the display to confirm recognition that the wash cycle was aborted The tank will be drained of fluids and the display will return to the Load Instruments screen when the tank draining is completed 5 Instruments inside the sonic irrigator must be processed in a new wash cycle 6 8 Wash Cycle Errors If an unexpected condition occurs the sonic irrigator will abort ...

Page 85: ...d and an error code is shown on the display 2 The reason for the abort should be investigated using the reported error code to diagnose the cause Follow advice given See Diagnosing Error Codes on page 114 3 After noting the error code reported touch OK on the display to confirm that the error has been recognized 4 If the tank was not empty when the abort occurred the tank will empty automatically ...

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Page 87: ... inspection 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 manufacturer CHAPTER 7 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 88: ...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 89: ...e by a suitably qualified technician 7 2 Daily Cleaning and Inspection 1 Make sure there is sufficient chemical in the chemical bottle s for the day s planned wash cycles 2 Open the lid Inspect the lid seal and lid spray nozzles Make sure the lid seal is in good condition Make sure the lid spray nozzles are not blocked and are free of debris 3 Remove the basket from the tank and inspect Make sure ...

Page 90: ...ner wipe all external surfaces of the sonic irrigator 8 With a clean wet cloth remove any trace of disinfectant cleaner from internal and external surfaces of equipment and lid 9 Cleaning performance should be tested each day equipment is used and all test results recorded 7 3 Weekly Cleaning and Inspection 1 Perform all daily cleaning and inspection See Daily Cleaning and Inspection on the previo...

Page 91: ... the clock symbol The touchscreen buttons below the current time and date are used to adjust settings 7 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 92: ...ination After Standing Idle on the facing page should be used 1 Perform the daily cleaning procedure See Daily Cleaning and Inspection on page 81 2 Put the basket in the tank Make sure the basket is fully docked and both side catches engage over the top of the basket 3 Close the lid and pull the lid handle forward to engage lid locks 4 On the display select the P6 Decontamination wash program Alte...

Page 93: ...ination the procedure below should be performed before using the equipment to process instruments WARNING Chemical burn and or eye injury hazard Chemicals are caustic and can cause adverse effects to exposed tissues l DO NOT get chemicals in eyes on skin or attempt to consume orally l Read and follow the precautions and instructions on the chemical label and in the Safety Data Sheet SDS prior to h...

Page 94: ...hlorite 5 is equivalent to 2150 ml 72 7 US fl oz 3 Put the container of disinfectant solution in the basket 4 Push a luer hose with attached distal connector into a flush port in all corners of the basket This aids circulation to ensure all basket manifolds are disinfected 5 Put the basket in the tank Make sure the basket is fully docked and both side catches engage over the top of the basket 6 Cl...

Page 95: ...tificate MUST be attached to the outside of the packing crate 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 7 7 Accessories and Replacement Parts A range of manufacture...

Page 96: ... pack of 10 IW1065 Si Multi basket and hose set IW1068 Si Multi complete hose and luer pack 10 x Si hose and luer 10 x single site hose 10 x Si stapler adapter IW1038 Xi basket and hose set IW1039 Xi complete hose and luer pack of 6 IW1006 Maxi Rinse basket MED8557 Detergent pick up 2 5 gallon intake hose and level sensor HOSE007 Water inlet hose stainless steel MP23432 Flexible drain hose MED3020...

Page 97: ...ncluded in this manual See Service Record on page 150 The recommended date for next service should be noted and service booked by this date 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 manufacturer MAINTE...

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Page 99: ...92 8 2 Unlocking the Supervisor Menu 93 8 3 Changing the Supervisor PIN 93 8 4 Viewing and Editing Wash Program Parameters 94 8 5 Selecting 12 Hour or 24 Hour Clock Setting 99 8 6 Selecting Metric or US Units for the Display and Cycle Logs 99 8 7 Changing the Language Used by the Display 100 CHAPTER 8 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 100: ...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 101: ...pervisor 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 the Supervisor Menu touch or repeatedly until the padlock symbol and ...

Page 102: ...New Pin 8 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 display will read Edit Program If a wash program is locked a padlock s...

Page 103: ...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 104: ...assing and or washing periods and or increase the set wash temperature 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 t...

Page 105: ...ort with Error 56 Low Irrigation Pressure The Wash Pressure parameter should be set no higher than the minimum irrigation pressure required for the instruments to be processed Setting an unnecessarily high Wash Pressure may cause the wash cycle to abort with Error 56 Low Irrigation Pressure Washing On the left is the quantity of detergent dispensed 0 to 2000 ml or 0 to 67 6 fl oz In the center is ...

Page 106: ...y set disinfection wash programs meet or exceed FDA requirements for intermediate level disinfection and are ISO 15883 1 2006 AMD1 2014 compliant Outside of factory set disinfection wash programs disinfection 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 le...

Page 107: ...n menu functions 8 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 93 2 For temperature touch or repeatedly until th...

Page 108: ...gle 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 8 7 Changing the Language Used by the Display 1 Unlock the supervisor menu using the supervisor PIN See Unlocking the Supervisor Menu on page 93 2 On the display touch or repeatedly until the symbol is centered and Language appears 3...

Page 109: ...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 101 InnoWave PCF Sonic Irrigator Operator Manual ...

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Page 111: ...e This chapter describes the rewash feature which may be available on some configurations 9 1 Rewash Program Setting 104 9 2 The Rewash Counter 104 9 3 On Completion of a Rewash Cycle 105 CHAPTER 9 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 112: ...cessed 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 no higher than 35 ºC 95 ºF High temperature washes without a pre wash cycle can leave clotted blood on instruments and can promote formation of prions leading to instrument contamination ...

Page 113: ... operator is not given the option to retain tank fluids and the tank automatically drains at the end of the cycle At the end of each day the tank should be emptied 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 ...

Page 114: ...ting the next cycle as soon as it starts See Pausing or Aborting a Wash Cycle on page 76 6 Wearing gloves suitably rated for thermal protection remove the basket from the full tank of fluids and move to an unloading area away from the sonic irrigator 7 Remove instruments from the basket See the section on Using Instrument Baskets on page 31 and follow the unloading procedure specific to the basket...

Page 115: ...d in internal memory and can either be downloaded onto a USB flash drive or sent to a thermal printer or data logging PC connected via the external RS232 port 10 1 Connecting a Device to the RS232 Port 108 10 2 Paper Run Out on Printer 109 10 3 Downloading Wash Cycle Logs to a USB Flash Drive 110 CHAPTER 10 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 116: ...inter to the RS232 Port 1 Connect an RS232 data cable to the port marked PRINTER on the rear of the sonic irrigator 2 Connect the RS232 data cable to the thermal printer 3 Connect the thermal printer to a suitable mains power outlet 4 Load paper into the thermal printer according to the accompanying instructions 5 Run a test wash cycle to make sure that the wash cycle log is printing correctly 108...

Page 117: ...r size 500 Stop bits 1 Append line feed to cartridge return 4 Run a test wash cycle to make sure that the wash cycle log is transferred correctly 10 2 Paper Run Out on Printer When a red stripe appears on the paper printout this is an indication that the paper roll is about to run out and should be replaced promptly If the printer runs out of paper 10 wash cycles can be stored in memory as long as...

Page 118: ...ogs 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 files being copied and show a progress bar Note Do NOT remove the USB flash drive until instructed to do so by...

Page 119: ...ive 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 WASH CYCLE LOGS 111 InnoWave PCF Sonic Irrigator Operator Manual ...

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Page 121: ... 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 122: ...ring Chemicals on page 25 Make sure water pressure is not too high See Viewing and Editing Wash Program Parameters on page 94 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 68 Make sure instruments are not blocking drain Make sure drain hose is no...

Page 123: ...spection 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 ...

Page 124: ...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 125: ...are docked correctly See Docking the Basket into the Tank on page 64 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 126: ...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 127: ...tion 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 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 Overfill occurred during cool down process Make sure that the filter is clean and n...

Page 128: ...et docking ports on the carrier Make sure that all docking port seals are present and in good condition See Daily Cleaning and Inspection on page 81 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 81 Repeat cycle If problem persists contact supplier to arrange a ...

Page 129: ... is incorrect for the equipment the internal circuit breaker may have tripped Contact supplier 11 2 1 2 Basket does not release from the tank l Make sure that instruments within the basket have not moved and are not protruding through the basket preventing unloading Reposition any instruments that have moved l Make sure that the luer hoses and connections have not detached and are not protruding t...

Page 130: ... moved and are not protruding through the basket preventing docking Reposition any instruments that have moved l Make sure that luer hoses and connections have not detached and are not protruding through the basket preventing docking Reposition any hoses that appear to have moved 11 2 1 4 Water leaking from the lid area l Make sure that all instruments in the basket are lying flat and no instrumen...

Page 131: ...al 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 making sure that the chemical bottle and chemical pickup are in a...

Page 132: ...icator s do not confirm expected equipment performance l Make sure that indicator s are placed on base of the basket in accordance with the indicator IFU l If the indicator IFU states that the tank must be empty NO medical instruments or other items should be loaded l The equipment basket should always be used and the indicator s placed inside the baskets l Make sure to use only a chemical that is...

Page 133: ...1 Wash Program Configuration 126 12 2 Wash Programs Default Parameters 127 12 3 P1 da Vinci Disinfection Program 127 12 4 P2 da Vinci Wash Cycle Program 128 12 5 P3 Standard Instruments Program 128 12 6 P4 P5 Open Programs 128 12 7 P6 Decontamination Program 129 CHAPTER 12 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 134: ...screen Touching scrolls up through the programs and touching scrolls down through the programs The parameters used by each wash program can be viewed in the supervisor menu See Viewing and Editing Wash Program Parameters on page 94 A summary of the preset program parameters is shown in Wash Programs Default Parameters on the facing page IMPORTANT It is recommended that wash program parameters are ...

Page 135: ... The da Vinci Disinfection Program is validated to clean and thermally disinfect with certainty up to 10 Si S robotic instruments or up to 6 Xi X robotic instruments IMPORTANT Instruments should be pre soaked or processed in a da Vinci Wash Cycle before using a da Vinci Disinfection program If in doubt always process instruments in a da Vinci Wash Cycle before using the da Vinci Disinfection progr...

Page 136: ...The tank is refilled from hot and cold inlets Detergent is dispensed and mixed with tank water When the tank is full the fluids are heated to and ultrasonics are used remove any dissolved gases Washing alternates between ultrasonic irrigation and lumen flushing and spraying At the end of washing the tank is emptied Rinsing removes chemical and any remaining soil from instruments The tank is emptie...

Page 137: ...a full decontamination of the sonic irrigator following the procedure described in Performing a Weekly Full Decontamination on page 84 This wash program is locked and can only be adjusted by a manufacturer approved service technician WASH PROGRAMS 129 InnoWave PCF Sonic Irrigator Operator Manual ...

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Page 139: ...ion 133 13 4 Overall Dimensions and Weight 134 13 5 Tank Dimensions and Capacity 134 13 6 Standard Basket Dimensions and Capacity 134 13 7 Si Basket Capacity 135 13 8 Si Multi Basket Capacity 135 13 9 Xi Multi Basket Capacity 135 13 10 Maxi Rinse Basket Capacity 136 13 11 Languages 136 13 12 Environmental Performance 136 CHAPTER 13 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 140: ...e frequency sweep Irrigation system Four 5 port manifolds on corners of basket producing up to 3 0 bar 43 5 psi at a flow rate of 2 9 liters min 100 US fl oz min Water temperature monitoring Measurement range 2 ºC to 98 ºC 36 ºF to 208 ºF Temp display 5 ºC to 98 ºC 41 ºF to 208 ºF accuracy 0 5 Drainage system Unit operated valve and drain pump Drain outlet 19 mm 3 4 in hose tail Effluent temperatu...

Page 141: ... 1 US gal Total volume waste water cooling active Cold Hot 109 liters 61 liters 28 8 US gal 16 1 US gal Table 13 2 Water Consumption for P1 Da Vinci Disinfection Program 13 3 Power Consumption The power consumption will vary depending on the volume of instruments loaded and the temperature of inlet water supply The power consumption below describes a da Vinci Disinfection wash program with no inst...

Page 142: ... and Capacity Metric US Units Maximum interior length2 668 mm 26 3 in Interior width 338 mm 13 3 in Interior depth 126 mm 5 0 in Maximum load weight 20 0 kg 44 0 lb Connections Four 5 port flush manifolds DIN basket compatibility Full DIN tray standard to hold instruments 484 x 253 x 76 mm 19 0 x 10 0 x 3 0 in 1 Weight includes equipment fully loaded with chemicals basket full of instruments luer ...

Page 143: ...al dimensions as the Standard basket The Si Multi Basket is specifically designed to connect to and support da Vinci Si S EndoWrist instruments and Si S staplers Connections 20 flush port connections Instrument capacity 10 Si S instruments up to 6 Si S staplers 13 9 Xi Multi Basket Capacity The Xi Multi Basket has the same physical dimensions as the Standard basket The Xi Multi Basket is specifica...

Page 144: ...set to any of the following Available Languages English Italian Polish Danish Japanese Portuguese Finnish Latvian Russian French Lithuanian Spanish German Norwegian Swedish 13 12 Environmental Performance Aspect Detail 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...

Page 145: ...initions and Symbols This chapter details terms and definitions used throughout this manual and symbols which may appear on equipment 14 1 Terms and Definitions 138 14 2 Visual Symbols 146 CHAPTER 14 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 146: ... tray or frame designed to hold or contain instruments during wash operation C Cannulated A thin tube or vessel feature Caution Advice alerting personnel to a risk that can potentially damage equipment Cavitation The foundation of ultrasonic cleaning occurs when ultrasonic energy is introduced into a cleaning solution This energy causes alternating low and high pressure phases During low pressure ...

Page 147: ...The hose provides chemicals detergent and lubricant to the sonic irrigator as demanded by wash settings Chemical pump s Internal pumps used to deliver detergent and lubricant into the tank Concentration A measure of the amount of dissolved substance contained per unit of volume Cycle A sequence of actions that equipment performs in order to clean instruments Also referred to as a program D Da Vinc...

Page 148: ...se to infection Dispensing Dispensation The action of chemical being transported in controlled measure from chemical bottle into tank Distal connector A special connector that attaches to and facilitates flushing through hollow and cannulated instruments E Effluent Waste fluids expelled from tank when a draining action is performed Enclosure A space under the chamber intended for storage of chemic...

Page 149: ...lso flushing L Locked Describes factory set parameters and wash programs that cannot be edited on unit Log A record of key wash cycle information The record of wash cycle information Lubricant A water soluble fluid applied to mechanical surgical instruments A lubricant can reduce wear and friction and prevent staining and corrosion during sterilization and storage Luer hose A hose that connects to...

Page 150: ... is overfilled and does not spill over unit or floor P Pre wash A preliminary washing action performed before washing actions to remove less stubborn contaminants from instruments Precaution Describes an action or measure taken in advance to avert or minimise the risk of harm to persons and or damage to equipment Prime Priming An action that fills chemical pump and hoses from chemical bottle to ta...

Page 151: ...ater is reused for multiple wash cycles as defined within cycle settings setup by operator with supervisor access S Set Point The temperature parameter within a wash program that is used alongside temperature sensors to control heating of tank fluids Si S instruments A range of instruments made by Intuitive Surgical within the brand of Da Vinci The cleaning and processing of Si S instruments requi...

Page 152: ... washed Also refered to as chamber U Ultrasonic Vibration waves in the high frequency range greater than 20 kHz W Warning Advice alerting of a danger that can potentially cause personal injury or death Waste Water Cooling An equipment feature that when enabled adds cold water from site inlet to hot waste water after draining from the tank so that the temperature of effluent at the drain outlet is ...

Page 153: ...ive Surgical within the brand of Da Vinci The cleaning and processing of Xi X instruments requires procedures as described in this manual that are specific to the instrument type TERMS DEFINITIONS AND SYMBOLS 145 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 154: ...nual 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 with this equipment Date of Manufacture Accompanied by date of ...

Page 155: ...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 Electrical and Electronic Equipment WEEE Follow the directive for WEEE in disposal of equipment Table 14 1 Visual Symbols continued TERMS DEFI...

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Page 157: ...ppendices Appendix A Service Record 150 Appendix B Training Records 151 Appendix C Decontamination Certificate 153 Appendix D Operator and Supervisor Authorization Codes 155 InnoWave PCF Sonic Irrigator Operator Manual ...

Page 158: ...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 159: ...Appendix B Training Records The table below can be used for keeping training records Date Name Title of training Signature of trainer InnoWave PCF Sonic Irrigator Operator Manual APPENDICES 151 ...

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Page 161: ...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 InnoWave PCF Sonic Irrigator Operator Manu...

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Page 163: ...76 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 Superv...

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Page 165: ...lation pump 74 Classifications 132 Compliance 20 Contact details i 124 D Date of manufacture 18 146 Decontamination Certificate 85 87 153 full decontamination 82 84 85 129 153 Designation 132 Detergent See Chemicals Display touchscreen ii 17 21 23 29 30 70 73 74 76 83 84 92 94 99 100 104 105 110 114 121 126 132 136 entering operator PIN unlocking 22 menu navigation 23 Disposal of equipment 20 147 ...

Page 166: ...facturer information 18 Menu main menu 23 92 99 100 supervisor menu ii 24 26 84 87 91 94 99 100 104 126 128 P PIN number operator codes 155 operator PIN 22 supervisor PIN 24 92 93 95 99 100 155 Printer data logging PC connection 107 109 paper run out 109 RS232 Port ii 107 109 thermal printer 15 107 108 Progress bar 73 110 R Replacement parts 6 26 87 Rewash on completion of cycle 104 105 rewash cou...

Page 167: ... 132 control accuracy 132 Training recommended 11 records 11 151 Transportation 9 lifting 9 Troubleshooting ii 113 121 check chemical message 123 error code 76 121 U Ultrasonic system 132 Units metric or US units setting ii 92 99 USB data port 110 downloading logs ii 110 USB flash drive 15 24 107 110 User interface 132 V Visual symbols 146 W Wash cycle abort ii 33 76 105 completion 74 degassing 72...

Page 168: ...pressure supply 10 14 15 33 73 92 97 99 114 123 127 temperature 4 35 75 95 104 106 117 132 Weight maximum load 32 134 136 160 INDEX InnoWave PCF Sonic Irrigator ...

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