Summary of Contents for Steris InnoWave PCF Sonic Irrigator
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InnoWave™ PCF Sonic Irrigator Operator Manual ENGLISH...
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(i) such release, disclosure or use is necessary for emergency repair or overhaul; (ii) such release, disclosure, or use is made subject to a prohibition that the person to whom the data is released or disclosed may not further release, disclose, or use such data; (iii) STERIS is notified of such release, disclosure or use.
InnoWave PCF Sonic Irrigator Operator Manual Revision History Revision Date Summary 12 Jan 2017 First release. 15 Mar 2017 Updated detergents. 10 Oct 2017 Updated daily checks. 18 Jan 2018 Updated basket size, seismic, drain cooling, daily checks, supervisor limits.
InnoWave PCF Sonic Irrigator Operator Manual Table of Contents Publication Details Revision History Safety Information 1.1 Safety Precautions 1.2 Personal Protective Equipment 1.3 Transportation and Storage 1.3.1 Lifting 1.3.2 Storage Markings 1.3.3 Environmental Conditions 1.4 Independent Monitoring 1.5 Recommended Operator Training General Information 2.1 Intended Purpose of Equipment...
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InnoWave PCF Sonic Irrigator Operator Manual 4.5.2 Lubricant Pump Priming Using Instrument Baskets 5.1 Basket Selection 5.2 Basket Care and Inspection 5.2.1 Basket Frame — Care 5.2.2 Basket Manifolds — Care 5.2.3 Basket Flush Ports — Care 5.3 Removing the Basket from the Tank 5.4 Standard Basket...
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InnoWave PCF Sonic Irrigator Operator Manual 7.2 Daily Cleaning and Inspection 7.3 Weekly Cleaning and Inspection 7.4 Checking the Time and Date Settings 7.4.1 Time Setting Adjustment 7.4.2 Date Setting Adjustment 7.5 Performing a Weekly Full Decontamination 7.6 Performing a Full Decontamination After Standing Idle 7.7 Accessories and Replacement Parts...
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InnoWave PCF Sonic Irrigator Operator Manual 11.2.2.1 Check Chemical appears on the display. 11.2.2.2 Instruments not clean after wash cycle. 11.2.2.3 Sonic and/or cleaning efficacy indicator(s) Wash Programs 12.1 Wash Program Configuration 12.2 Wash Programs Default Parameters 12.3 P1: da Vinci Disinfection Program 12.4 P2: da Vinci Wash Cycle Program...
InnoWave PCF Sonic Irrigator Operator Manual HAPTER Safety Information CAUTION — Read this section Users should read this section entirely before attempting to operate the equipment described. Users MUST, at all times, observe ALL warnings and cautions described in safety information.
InnoWave PCF Sonic Irrigator Operator Manual Safety Precautions The following safety precautions must be observed when operating or servicing the equipment. WARNING indicates potential for personal injury. CAUTION indicates potential for damage to equipment. For emphasis, certain safety precautions are repeated throughout this manual. It is important to review ALL safety precautions before operating or servicing the equipment.
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InnoWave PCF Sonic Irrigator Operator Manual WARNING — Electric shock hazard To avoid the risk of electric shock, this equipment must be connected to a mains supply with a protective earth. Dangerously high voltages are present inside the equipment. DO NOT remove any panels or attempt to gain access to the interior of the electrical cabinet.
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InnoWave PCF Sonic Irrigator Operator Manual WARNING — Burn hazard Temperatures within the equipment can reach +98 °C (+208 °F) during and after operation. Take care when opening the lid at the end of a wash cycle. Allow sufficient time for items to cool before handling, cleaning, or commencing maintenance procedures.
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InnoWave PCF Sonic Irrigator Operator Manual WARNING — Slipping hazard Fluids spilled on floors can cause a slipping hazard. Immediately wipe up any spilled liquid or condensation. If spills or leaks contain chemicals, ALWAYS follow the safety precautions and handling procedures on the chemical label and/or the Safety Data Sheet (SDS).
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InnoWave PCF Sonic Irrigator Operator Manual 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.
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InnoWave PCF Sonic Irrigator Operator Manual CAUTION — Equipment damage This equipment should NOT be used for any purpose other than that defined by the manufacturer as a sonic irrigator. NEVER place items or person(s) on the lid as this may result in damage to the equipment.
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InnoWave PCF Sonic Irrigator Operator Manual CAUTION — Basket Loading The weight of a basket loaded with instruments MUST NOT exceed 20 kg (44 lb). Instruments should be distributed evenly around the basket. Avoid instruments contacting each other if possible. Place instruments individually into the basket. Avoid tipping or dropping multiple instruments from a bin into the basket.
InnoWave PCF Sonic Irrigator Operator Manual Personal Protective Equipment When operating or servicing the equipment, the following Personal Protective Equipment (PPE) must be worn: Goggles / safety glasses Protective gloves Protective clothing Boots with toe protection Transportation and Storage Make sure package marking instructions and environmental conditions are always followed during transport and storage of the equipment.
InnoWave PCF Sonic Irrigator Operator Manual 1.3.3 Environmental Conditions This equipment can be transported and stored safely in the following environmental conditions: Temperature range: +2 ºC to +60 ºC (+36 ºF to +140 ºF) Pressure range: 0.50 bar to 1.06 bar...
InnoWave PCF Sonic Irrigator Operator Manual Recommended Operator Training IMPORTANT The equipment owner has responsibility for training and keeping training records for all persons involved in operating and maintaining this equipment. Training should be regularly reviewed. It is recommended that operator training should cover, as a minimum, the following...
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InnoWave PCF Sonic Irrigator Operator Manual HAPTER General Information This chapter provides general information about the equipment. 2.1 Intended Purpose of Equipment 2.2 Equipment Features 2.3 Identifying Features on the Equipment 2.4 Equipment Identification 2.5 Manufacturer Information 2.6 Applied Standards 2.7 Compliance...
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 interchangeable instrument baskets enable cleaning and processing of general, cannulated, and da Vinci® Si/S and Xi/X robotic instruments.
InnoWave PCF Sonic Irrigator Operator Manual Wash program settings control duration of each stage, temperature of tank fluids, quantity of detergent or lubricant added, wash pressure for irrigation, and water cooling. During the wash cycle, parameters are reported at key stages of the process and can be logged on a connected thermal printer or computer.
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InnoWave PCF Sonic Irrigator Operator Manual LID CONNECTION HOSE (x2) LID LOCK OVERRIDE GAS SPRING (x2) LID CONNECTOR OVERFLOW MANIFOLD REAR ACCESS PANEL COLD WATER CONNECTOR HOT WATER RO WATER DRAIN CONNECTOR CONNECTOR OUTLET Figure 2.2 Rear view SPRAY NOZZLES (x8)
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InnoWave PCF Sonic Irrigator Operator Manual Table 2.1 Features locator Feature Location Feature Location Basket guide (x4) Figure 2.3 Left side access panel Figure 2.1 Basket locking assembly (x2) Figure 2.3 Figure 2.1 Caster (x4) Figure 2.1 Lid connection hose (x2) Figure 2.2...
InnoWave PCF Sonic Irrigator Operator Manual Equipment Identification The model reference, serial number, and manufacturer information is displayed on a label attached inside the chemical enclosure of the equipment. InnoWave™ PCF Manufactured for: STERIS Corpora�on Sonic Irrigator 5960 Heisley Rd Mentor, OH 44060, USA Medisafe UK Ltd.
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InnoWave PCF Sonic Irrigator Operator Manual Table 2.2 Applied Standards Standard Title ANSI C63.4-2014 American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz. EN 1717:2000...
InnoWave PCF Sonic Irrigator Operator Manual Table 2.2 Applied Standards (continued) Standard Title EN 61326-1:2020 Electrical equipment for measurement, control and BS EN/IEC 61326-1:2021 laboratory use. EMC requirements. General requirements. IEC 62304:2006+AMD1:2015 Medical device software. Software life-cycle processes. IEC 62366- Medical devices —...
InnoWave PCF Sonic Irrigator Operator Manual HAPTER The Touchscreen Display This chapter describes the use of the touchscreen display. 3.1 Purpose of The Touchscreen Display 3.2 Screen-saver Mode on the Display 3.3 Entering an Operator PIN (if enabled) 3.4 Menu Navigation 3.5 Main Menu Functions...
InnoWave PCF Sonic Irrigator Operator Manual Purpose of The Touchscreen Display The touchscreen display is used to adjust wash cycle parameters and to operate the equipment. The display provides information on equipment settings and activity during wash cycle operations. Screen-saver Mode on the Display 1.
InnoWave PCF Sonic Irrigator Operator Manual Menu Navigation On the display, the symbols are used to scroll left and right through the menu. The large symbol in the center and any text below it indicate the current selection. Any operator choices are usually shown at the bottom of the display. To return to the main menu from any sub-menu, touch the return symbol at the top-left of the display.
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InnoWave PCF Sonic Irrigator Operator Manual Table 3.2 Main Menu Functions Symbol Name Function Commence the procedure for loading instruments, Wash cycle filling the tank, adjusting wash settings, and starting a wash cycle. Wash program Select wash program from preset selection.
InnoWave PCF Sonic Irrigator Operator Manual HAPTER Preparing Chemicals This chapter describes the use of chemicals (detergents and lubricants) with the sonic irrigator. 4.1 Use of Chemicals 4.2 Recommended Chemicals — North America Only 4.3 Recommended Chemicals — Outside North America 4.4 Replacing Chemical Bottles...
InnoWave PCF Sonic Irrigator Operator Manual Use of Chemicals The sonic irrigator has been designed to connect to detergent and lubricant bottles. 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.
InnoWave PCF Sonic Irrigator Operator Manual Recommended Chemicals — Outside North America Item number Description 1C39T6WR 8E-Zyme multi-enzymatic cleaner, 10.0 L (2.6 US gal) 1031T4PE Hinge-Free™ lubricant, 2 x 5.0 L (2 x 1.3 US gal) 1C21T6PE Prolystica™ HP neutral automated detergent, 10.0 L (2.6 US gal) 1C22T6PE Prolystica™...
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InnoWave PCF Sonic Irrigator Operator Manual Inside the chemical enclosure, the chemical pickup for detergent attaches to connections on the left labeled DETERGENT, as indicated by A in image. The chemical pickup for lubricant attaches to connections on the right labeled LUBRICANT, as indicated by B in image.
InnoWave PCF Sonic Irrigator Operator Manual 7. Put the chemical bottle inside the chemical enclosure. 8. Close the door of the chemical enclosure. 9. The chemical pump must now be primed to prevent chemical cross-contamination. See Priming Chemical Pumps below.
InnoWave PCF Sonic Irrigator Operator Manual 4. Touch Prime Chem. Pump at the bottom of the display. The button changes color to indicate that the detergent pump is now active and pumping detergent from the chemical bottle. 5. The detergent pump will operate and then turn off automatically.
InnoWave PCF Sonic Irrigator Operator Manual HAPTER Using Instrument Baskets This chapter introduces the range of basket types and describes the loading and unloading of instruments into each basket type. 5.1 Basket Selection 5.2 Basket Care and Inspection 5.3 Removing the Basket from the Tank 5.4 Standard Basket...
InnoWave PCF Sonic Irrigator Operator Manual Basket Selection Baskets for the sonic irrigator have been designed to process specific types of surgical instruments. It is important to select the correct basket for instrument processing. See the table below to select the correct basket for instruments.
InnoWave PCF Sonic Irrigator Operator Manual Basket Care and Inspection The following care and inspection advice applies to all basket types compatible with the equipment, although some details may vary in particular instances. Baskets require considerate care and regular inspection. Baskets treated harshly are susceptible to damage.
InnoWave PCF Sonic Irrigator Operator Manual The basket manifolds connect with ports within the tank. If a connection is compromised through damage to the manifold inlet, pressure to the flush ports is lost, and instruments cannot be effectively irrigated. 5.2.3 Basket Flush Ports —...
InnoWave PCF Sonic Irrigator Operator Manual Removing the Basket from the Tank The procedure for removing a basket from the tank is the same for all types of baskets compatible with this sonic irrigator. Baskets should always be removed from the tank for loading and unloading of instruments. Never place instruments directly in the tank.
InnoWave PCF Sonic Irrigator Operator Manual 3. When the side latches release, pull the basket up using the handles, keeping it level until completely removed from the tank. 4. With the basket above the tank, hold the basket momentarily to allow any fluids remaining in instruments and hoses to drain back into the tank.
InnoWave PCF Sonic Irrigator Operator Manual The basket can be used to process instruments of the following types: General surgical instruments 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.
InnoWave PCF Sonic Irrigator Operator Manual 2. Open mechanical instruments, such as scissors and clamps. 3. Place instruments in basket, distributing evenly. Make sure instruments do not protrude through basket or above top of basket. 4. Any small instruments that may fall through the basket should be first placed inside a mesh tray, and then placed in the basket.
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InnoWave PCF Sonic Irrigator Operator Manual Cannulated (lumened) instruments should be attached to basket flush ports to receive flushing during the wash cycle. A standard basket luer hose and a suitable- sized distal connector will be required to attach each instrument to a basket flush port.
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InnoWave PCF Sonic Irrigator Operator Manual 4. Push the instrument end through the distal connector silicone opening. Make sure the connection is not tight, but that the instrument does not fall out of the distal connector. 5. Select a luer hose for the standard basket. Inspect the luer hose. Make sure the luer hose has no kinks or ruptures.
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InnoWave PCF Sonic Irrigator Operator Manual 8. Attach the luer hose to a basket flush port. Always attach the luer hose to the top- most available flush port. Push the connector of the luer hose into the port until the retaining clip clicks to hold hose in position.
InnoWave PCF Sonic Irrigator Operator Manual 5.4.3 Standard Basket — Unloading IMPORTANT Before unloading instruments, inspect the basket for any hoses or connectors that may have detached from instruments. A detached hose or connector during the wash cycle can result in an instrument that may NOT have been cleaned or disinfected satisfactorily.
InnoWave PCF Sonic Irrigator Operator Manual 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. Si Basket The Si Basket is designed specifically to process da Vinci Si/S EndoWrist robotic instruments.
InnoWave PCF Sonic Irrigator Operator Manual 5.5.1 Si Basket — Loading IMPORTANT Always consult instrument manufacturer instructions for the processing of instruments. Instruments may require manual cleaning prior to processing in the sonic irrigator: such cleaning is outside the scope of this manual.
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InnoWave PCF Sonic Irrigator Operator Manual 4. Place the instrument into an aligned cutout slot on the other basket support. Never place the instruments at an angle across basket supports. 5. Attach the luer hose to an available basket flush port.
InnoWave PCF Sonic Irrigator Operator Manual 5.5.2 Si Basket — Unloading IMPORTANT Before unloading instruments, inspect the basket for any hose connectors that may have detached from either the instrument or the basket flush port. An instrument that is detached from a luer hose or flush port may NOT been cleaned or disinfected satisfactorily.
InnoWave PCF Sonic Irrigator Operator Manual 4. Lift the body of the instrument up above the basket, then pull the instrument shaft out of the basket support. Si Multi Basket The Si Multi Basket is designed specifically to process da Vinci Si/S EndoWrist robotic instruments and da Vinci Si/S stapler instruments.
InnoWave PCF Sonic Irrigator Operator Manual 5.6.1 Si Multi Basket — Si Single-Site Hose Connection 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.
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InnoWave PCF Sonic Irrigator Operator Manual 4. Hold the single-site hose. With the offset face of nozzle clamp facing the instrument body, feed the shaft of the instrument through the nozzle clamp opening. If the shaft does not easily pass through the nozzle clamp, turn the nozzle clamp counter-clockwise to increase the clearance.
InnoWave PCF Sonic Irrigator Operator Manual 5.6.2 Si Multi Basket — Loading Instruments 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.
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InnoWave PCF Sonic Irrigator Operator Manual 6. Arrange the instrument so that the body rests between anti-roll pins on the basket support. Never rest the instrument body on top of anti-roll pins, or force the instrument body under anti-roll pins.
InnoWave PCF Sonic Irrigator Operator Manual 9. The instrument is now loaded. Repeat the procedure for instrument loading for up to 10 Endowrist Si/S instruments. 10. It is recommended to have at least one instrument connected to each flush manifold in four corners of the basket.
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InnoWave PCF Sonic Irrigator Operator Manual 4. The stapler flush adapter connects to a port on the instrument shaft just below the body. 5. Slide the flush adapter clamping ring over the shaft of the instrument. Align the nozzle with the port and turn the hose clockwise to clamp onto the shaft.
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InnoWave PCF Sonic Irrigator Operator Manual 8. Feed the shaft of the instrument through a circular cut-out in the basket support. 9. 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.
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InnoWave PCF Sonic Irrigator Operator Manual 11. Attach luer hoses and stapler adapters to basket flush ports. Push hoses into ports until retaining clips click into position. Tug each hose gently to make sure the connection is secure. Make sure hoses are not kinked or constricted.
InnoWave PCF Sonic Irrigator Operator Manual 5.6.4 Si Multi Basket — Unloading IMPORTANT Before unloading instruments, inspect the basket for any hoses or connectors that may have detached from instruments. If adapters have been used, make sure that they have NOT detached from either the instrument shaft or the basket flush port.
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InnoWave PCF Sonic Irrigator Operator Manual 5. Lift the body of the instrument up above the basket, then pull the instrument shaft out of the basket support. 6. If the instrument is attached to a single-site hose or stapler adapter, turn the hose counter- clockwise to release the hose clamp, then pull the instrument out of the hose adapter.
InnoWave PCF Sonic Irrigator Operator Manual Xi Multi Basket The Xi Multi Basket is designed for use ONLY with da Vinci EndoWrist Xi/X robotic instruments. No other types of instruments should be used with this basket. The Xi Multi Basket only accepts Xi hoses and luers. Hoses and luers from other baskets are not compatible.
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InnoWave PCF Sonic Irrigator Operator Manual 4. 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 with two securing lugs on the basket support.
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InnoWave PCF Sonic Irrigator Operator Manual 7. Attach the da Vinci luer hose to the instrument body ports. The luer hose should face towards the middle of the basket. 8. Attach the luer hose to an available basket flush port. Push the connector of the luer hose into the flush port until the retaining clip clicks to hold the luer hose in position.
InnoWave PCF Sonic Irrigator Operator Manual 5.7.2 Xi Multi Basket — Unloading IMPORTANT Before unloading instruments, inspect the basket for any hoses or connectors that may have detached from instruments. If adapters have been used, make sure that they have NOT detached from either the instrument shaft or the basket flush port.
InnoWave PCF Sonic Irrigator Operator Manual 4. Squeeze both release buttons on the body of the instrument then pull the body away from the basket lugs. 5. Pull the instrument up and away from the basket. Maxi Rinse Basket The Maxi Rinse Basket has 4 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.
InnoWave PCF Sonic Irrigator Operator Manual 5.8.1 Maxi Rinse Basket — Loading CAUTION — Basket Loading The weight of a basket loaded with instruments MUST NOT exceed 20 kg (44 lb). Instruments should be distributed evenly around the basket. Avoid instruments contacting each other if possible.
InnoWave PCF Sonic Irrigator Operator Manual 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. Docking the Basket into the Tank This procedure applies to all basket types compatible with the PCF ultrasonic irrigator.
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InnoWave PCF Sonic Irrigator Operator Manual 3. Inspect the tank docking ports. The docking ports should be clear of any debris or deposits, and the red silicone port seal should be present and in good condition. 4. Make sure that no instruments protrude through or above the basket and that no instruments are pointing upwards.
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InnoWave PCF Sonic Irrigator Operator Manual 7. Let go of the basket handles and make sure the side latches engage over the top edge of the basket on both sides. If necessary, push the basket down using the basket handles until both side latches are engaged.
InnoWave PCF Sonic Irrigator Operator Manual HAPTER Performing a Wash Cycle This chapter describes how to start a wash cycle, monitor progress of the wash cycle, and confirm completion of a successful wash cycle. The equipment should first be prepared and...
InnoWave PCF Sonic Irrigator Operator Manual Cleaning and Inspection Before Every Wash Cycle WARNING — Chemical burn and/or eye injury hazard Chemicals are caustic and can cause adverse effects to exposed tissues. DO NOT get chemicals in eyes, on skin, or attempt to consume orally.
InnoWave PCF Sonic Irrigator Operator Manual 2. If the tank is empty, remove the tank filter for cleaning. Remove any soil, clean with disinfectant cleaner, then rinse under running water. Fit the filter back into the tank, making sure it is sits flat in the tank recess.
InnoWave PCF Sonic Irrigator Operator Manual The wash program that the sonic irrigator uses for the next wash cycle is shown on the Load Instruments screen. The sonic irrigator defaults to the wash program last used: to select a different wash program, follow the procedure below.
InnoWave PCF Sonic Irrigator Operator Manual 5. If not already done, dock the loaded basket into the tank. Follow instructions in Docking the Basket into the Tank on page 64. 6. Close the lid fully. 7. Touch Start at the bottom-left of the display.
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InnoWave PCF Sonic Irrigator Operator Manual Table 6.1 Wash Cycle Stages (continued) Filling Tank fills to the max. level from hot & cold water inlets. Dispensing Chemical 1 added when the tank level becomes half-full. Heating Water circulates thru lumens and is heated to point set.
InnoWave PCF Sonic Irrigator Operator Manual Information on the Display During a Wash Cycle Figure 6.1 Example of the display during a wash cycle A. Pause; touch to pause wash cycle. B. Current wash cycle stage. C. Temperature of fluids (water and chemical mix) in tank.
InnoWave PCF Sonic Irrigator Operator Manual Table 6.2 Wash Activity Symbols Symbol Meaning Represents the inlets to tank. Blue represents cold water inlet, red represents hot water inlet, yellow represents chemical inlets, and green represents RO water inlet. When an inlet is open, allowing fluids into tank, a "stream" is shown under the inlet operating.
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InnoWave PCF Sonic Irrigator Operator Manual 2. Touch Unload on the display to confirm the cycle completed with no errors. The Cycle Complete - Unload screen appears and the lid lock is disengaged. 3. Open the lid slowly and partially to allow hot vapors to escape from the chamber.
InnoWave PCF Sonic Irrigator Operator Manual Pausing or Aborting a Wash Cycle During wash cycle operations it is possible to pause or abort the wash cycle if required. 1. During a wash cycle operation, touch the pause symbol located at the top-left of the display.
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InnoWave PCF Sonic Irrigator Operator Manual WARNING When 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.
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InnoWave PCF Sonic Irrigator Operator Manual HAPTER Maintenance This chapter describes routine maintenance of the equipment, including periodic cleaning and 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.
InnoWave PCF Sonic Irrigator Operator Manual Important Safety Information 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.
InnoWave PCF Sonic Irrigator Operator Manual CAUTION In the interests of health and safety, all medical washers should be cleaned as part of a routine maintenance program. This will ensure that the equipment is safe for operators and maintenance personnel. To keep your equipment operating within the design parameters, the following checks must be performed on a regular basis.
InnoWave PCF Sonic Irrigator Operator Manual 4. Pull the filter up and away to remove it from the tank. Remove any soil from the filter and then wipe it with disinfectant cleaner and refit into the tank. 5. With a clean cloth and disinfectant cleaner, wipe all internal surfaces of the tank if the tank is empty, otherwise all exposed internal surfaces above the water level.
InnoWave PCF Sonic Irrigator Operator Manual Checking the Time and Date Settings The time and date should be set correctly to ensure the accuracy of wash cycle records, and should be periodically checked by the operator. There is no automatic provision for adjusting to daylight saving hours.
InnoWave PCF Sonic Irrigator Operator Manual 3. On the Set Time screen, touch adjust day, month, year settings as required. 4. Touch to return to the main menu. Performing a Weekly Full Decontamination The decontamination procedure described below is suitable if performed weekly. If...
InnoWave PCF Sonic Irrigator Operator Manual 6. Confirm the wash cycle completes with no errors. 7. If preparing the sonic irrigator for shipping, fill out a Decontamination Certificate. Decontamination Certificate on page 153. The Decontamination Certificate MUST be attached to the outside of the packing crate.
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InnoWave PCF Sonic Irrigator Operator Manual 1. Perform the daily cleaning procedure. See Daily Cleaning and Inspection page 81. 2. Put a disinfectant solution of 5% non-foaming Sodium Hypochlorite into a shallow heat-resistant container (this prevents it from being drained at start of cycle).
InnoWave PCF Sonic Irrigator Operator Manual 7. On the display, select the P6: Decontamination wash program. Alternatively, a custom decontamination program can be defined using the supervisor menu if required. 8. Start the wash cycle. 9. With 30 seconds of the pre-wash stage remaining, press on the display to pause the cycle.
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InnoWave PCF Sonic Irrigator Operator Manual Table 7.1 Accessories and Parts List Item number Description IW1062 Standard basket and hose set IW1025 Instrument organizer MP22183 Standard hose and luer (pack of 20) IW1026 Distal connectors red, 1 mm (pack of 10)
InnoWave PCF Sonic Irrigator Operator Manual Equipment Servicing It is recommended that this equipment is serviced every 6 months. Servicing should only be performed by a supplier-approved service technician. When the equipment is serviced, the service technician will update the service record included in this manual.
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InnoWave PCF Sonic Irrigator Operator Manual HAPTER The Supervisor Menu This chapter describes use of the supervisor menu. 8.1 Functions Available Through the Supervisor Menu 8.2 Unlocking the Supervisor Menu 8.3 Changing the Supervisor PIN 8.4 Viewing and Editing Wash Program Parameters 8.5 Selecting 12-Hour or 24-Hour Clock Setting...
InnoWave PCF Sonic Irrigator Operator Manual Functions Available Through the Supervisor Menu The supervisor menu provides the following functions: Change the PIN used to unlock the supervisor menu. View factory-set wash programs settings. Edit user-definable wash programs settings. Select either the 12-hour or 24-hour clock setting for time on the display.
InnoWave PCF Sonic Irrigator Operator Manual Unlocking the Supervisor Menu 1. On the display, from the main menu, touch repeatedly until the supervisor symbol is centered and Supervisor Menu appears at the bottom of the screen. 2. Touch once on Supervisor Menu at the bottom of the screen.
InnoWave PCF Sonic Irrigator Operator Manual 5. Use the number pad on display to confirm the new 6-digit supervisor PIN. 6. If the new supervisor PIN entered the first and second time do not match, the supervisor PIN will not be changed and you must try again.
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InnoWave PCF Sonic Irrigator Operator Manual 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 desired wash program name appears under the wash program symbol .
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InnoWave PCF Sonic Irrigator Operator Manual IMPORTANT Sonic activity during the degassing and washing stages of a wash program can increase the temperature of the tank water at a rate up to 0.5 °C/min. (0.9 °F/min.). Setting a hot wash cycle with a long period of degassing and a long duration...
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InnoWave PCF Sonic Irrigator Operator Manual Wash Pressure This sets the minimum irrigation pressure required for instrument cleaning. If the pressure falls below the set limit during irrigation flushing, the cycle will abort and Error 56 appears on the display.
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InnoWave PCF Sonic Irrigator Operator Manual Rinsing On the left is the water temperature (0 °C to +60 °C, or +32 °F to +140 °F). In the center is the duration in minutes (0 to 20). On the right is the number of times the rinsing stage is performed (0 to 3). If either duration or number of times is set to zero, rinsing is not performed.
InnoWave PCF Sonic Irrigator Operator Manual Selecting 12-Hour or 24-Hour Clock Setting 1. Unlock the supervisor menu using the supervisor PIN. See Unlocking the Supervisor Menu on page 93. 2. On the display, touch repeatedly until the symbol is centered. 3. Touch on Measurements at the bottom of the display to toggle between 12-hour and 24-hour clock setting.
InnoWave PCF Sonic Irrigator Operator Manual 4. For fluid volume, touch repeatedly until the symbol is centered. 5. Touch on Measurements at the bottom of the display to toggle between ml (milliliters) and floz (US fluid ounces) for fluid volume.
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InnoWave PCF Sonic Irrigator Operator Manual 4. The current language setting appears in the center of the display. Touch repeatedly until the desired language appears in the center of the display. Available languages appear in the following sequence: English, Danish, French, German, Japanese, Spanish, Swedish, Finnish, Italian, Polish, Russian, Portuguese, Norwegian, Lithuanian, Latvian 5.
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InnoWave PCF Sonic Irrigator Operator Manual HAPTER The Rewash Feature This chapter describes the rewash feature, which may be available on some configurations. 9.1 Rewash Program Setting 9.2 The Rewash Counter 9.3 On Completion of a Rewash Cycle THE REWASH FEATURE...
InnoWave PCF Sonic Irrigator Operator Manual Rewash Program Setting Within a wash program, if the rewash parameter is set above zero, the rewash feature is enabled. When the rewash feature is enabled, the tank fluids do not drain at the end of the first wash cycle. The operator then has the option to reuse the tank fluids for the next wash cycle.
InnoWave PCF Sonic Irrigator Operator Manual On Completion of a Rewash Cycle At the end of a rewash cycle, if the number of washes with tank fluids is less than the number set in the rewash counter, the tank fluids can be retained in the tank for the next wash cycle.
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InnoWave PCF Sonic Irrigator Operator Manual 4. Open the lid slowly and partially to allow hot vapors to escape from the tank. When hot vapors have escaped, the lid can be opened fully. WARNING — Burn hazard Temperatures within the equipment can reach +98 °C (+208 °F) during and after operation.
InnoWave PCF Sonic Irrigator Operator Manual HAPTER Wash Cycle Logs During wash operations, parameters are reported at key stages as an ASCII serial data stream. This cycle log is stored in internal memory and can either be downloaded onto a USB flash drive, or sent to a thermal printer or data logging PC connected via the external RS232 port.
InnoWave PCF Sonic Irrigator Operator Manual 10.1 Connecting a Device to the RS232 Port The following devices can be connected to the external RS232 port: • Thermal printer • Data logging PC IMPORTANT Only IEC/EN 60950-1 certified equipment should be connected to the RS232 port.
InnoWave PCF Sonic Irrigator Operator Manual 10.1.2 Connecting a Data Logging PC to the RS232 Port 1. Connect an RS232 null modem to the port marked DATA on the rear of the sonic irrigator. 2. Connect the RS232 data cable to the data logging PC.
InnoWave PCF Sonic Irrigator Operator Manual 10.3 Downloading Wash Cycle Logs to a USB Flash Drive 1. Make sure the USB flash drive is formatted to FAT32. Note: The following brands are recommended for use with this equipment: • Toshiba TransMemory •...
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InnoWave PCF Sonic Irrigator Operator Manual 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 WASH CYCLE LOGS...
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InnoWave PCF Sonic Irrigator Operator Manual HAPTER Troubleshooting This chapter describes error messages that may be shown, and behavior issues that may occur during operation of the equipment. When an error message or behavior issue occurs, use this section to identify common root causes, and corrective actions.
InnoWave PCF Sonic Irrigator Operator Manual 11.1 Diagnosing Error Codes Use the table below to diagnose and remedy error codes reported on the display. Table 11.1 Error Codes and Remedy Actions Error Error Message Description Code Mains power Mains supply to equipment was interrupted during a cycle.
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InnoWave PCF Sonic Irrigator Operator Manual Table 11.1 Error Codes and Remedy Actions (continued) Error Error Message Description Code Chamber fill timeout Make sure that the water inlet hoses are connected and not kinked or blocked. Make sure that the site water supply is on.
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InnoWave PCF Sonic Irrigator Operator Manual Table 11.1 Error Codes and Remedy Actions (continued) Error Error Message Description Code Chamber start Tank has not cooled sufficiently since last wash. Make sure temperature too high cold water supply is below +35 °C (+95 °F).
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InnoWave PCF Sonic Irrigator Operator Manual Table 11.1 Error Codes and Remedy Actions (continued) Error Error Message Description Code Low main pump Make sure that the filter is clean and not clogged. See step pressure 2 of Cleaning and Inspection Before Every Wash Cycle page 68.
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InnoWave PCF Sonic Irrigator Operator Manual Table 11.1 Error Codes and Remedy Actions (continued) Error Error Message Description Code Sonic generator over Switch the equipment off, then on again. If problem persists, temperature contact supplier to arrange a qualified technician inspection.
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InnoWave PCF Sonic Irrigator Operator Manual Table 11.1 Error Codes and Remedy Actions (continued) Error Error Message Description Code Micro-controller error Switch the equipment off, then on again. If problem persists, contact supplier to arrange a qualified technician inspection. Internal ambient Make sure room temperature is below +40 °C (+104 °F).
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InnoWave PCF Sonic Irrigator Operator Manual Table 11.1 Error Codes and Remedy Actions (continued) Error Error Message Description Code Low irrigation Make sure that P1: Standard Disinfect Cycle is NOT pressure selected for general instrument loads. See Selecting a Wash Program on page 69.
InnoWave PCF Sonic Irrigator Operator Manual 11.2 Troubleshooting Equipment Behavior This section describes equipment issues that may occur without showing an error code on the display. 11.2.1 General Equipment Issues Issues below relate to general equipment usage. For issues related to wash cycle...
InnoWave PCF Sonic Irrigator Operator Manual 11.2.1.3 Basket does not dock into the tank. Make sure that the underside of ALL FOUR basket manifolds are in a good condition, are free from debris, and are not damaged. Make sure that the basket is pushed down...
InnoWave PCF Sonic Irrigator Operator Manual 11.2.1.5 Excessive fill time. Make sure that the site water connections are sufficient and have pressure above 2.0 bar (29 psi). Make sure that site water valves are open. Make sure that the water inlet hoses are not kinked or constricted.
The equipment basket should always be used, and the indicator(s) placed inside the baskets. Make sure to use only a chemical that is recommended by STERIS and the indicator IFU. Make sure that the chemical dose is as stated in the wash program parameters, and the indicator IFU.
InnoWave PCF Sonic Irrigator Operator Manual HAPTER Wash Programs This chapter details the wash programs that may be setup on a sonic when shipped. 12.1 Wash Program Configuration 12.2 Wash Programs Default Parameters 12.3 P1: da Vinci Disinfection Program 12.4 P2: da Vinci Wash Cycle Program 12.5 P3: Standard Instruments Program...
InnoWave PCF Sonic Irrigator Operator Manual 12.1 Wash Program Configuration A total of 6 wash programs are stored on the sonic irrigator. The wash programs are set before the equipment is shipped. The table below describes the wash program configuration that is currently shipped.
InnoWave PCF Sonic Irrigator Operator Manual 12.2 Wash Programs Default Parameters Table 12.2 Wash Programs Default Parameters Program number Prewash Prewash duration 3 min 3 min 3 min Prewash times performed Washing Degassing duration 3 min 3 min 2 min...
InnoWave PCF Sonic Irrigator Operator Manual 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 and ultrasonics are used to remove any dissolved gases. Washing alternates between ultrasonic irrigation and lumen flushing and spraying.
InnoWave PCF Sonic Irrigator Operator Manual 12.7 P6: Decontamination Program The factory- set Decontamination program can be used to perform 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.
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InnoWave PCF Sonic Irrigator Operator Manual HAPTER Specification This chapter details performance and physical specifications of the equipment. 13.1 Performance 13.2 Water Consumption 13.3 Power Consumption 13.4 Overall Dimensions and Weight 13.5 Tank Dimensions and Capacity 13.6 Standard Basket Dimensions and Capacity 13.7 Si Basket Capacity...
InnoWave PCF Sonic Irrigator Operator Manual 13.1 Performance Table 13.1 Performance Specification Aspect Detail Equipment designation Healthcare Sonic Irrigator Medical device class IIb Class 1 electrical shock protection, externally powered No applied parts Classifications IP rating: IPX0 Not suitable for use in oxygen-rich environment...
InnoWave PCF Sonic Irrigator Operator Manual 13.2 Water Consumption Water consumption will vary depending on the volume of instruments loaded and the temperature of inlet water supply. The water consumption below describes a da Vinci Disinfection wash program with no instruments loaded.
InnoWave PCF Sonic Irrigator Operator Manual 13.4 Overall Dimensions and Weight Metric US Units External height (lid closed) 1083 mm 42.6 in. External height (lid open) 1493 mm 58.7 in. External width 877 mm 34.5 in. External depth (lid open) 706 mm 27.8 in.
InnoWave PCF Sonic Irrigator Operator Manual 13.7 Si Basket Capacity The Si Basket has the same physical dimensions as the Standard basket. The Si Basket is specifically designed to connect to and support da Vinci Si/S EndoWrist instruments and cannot be used with other instruments.
InnoWave PCF Sonic Irrigator Operator Manual 13.10 Maxi Rinse Basket Capacity The Maxi Rinse basket has the same physical dimensions as the Standard basket. The Maxi Rinse basket is designed to provide an intensive deluge wash for heavily- soiled instruments.
InnoWave PCF Sonic Irrigator Operator Manual HAPTER Terms, Definitions, and Symbols This chapter details terms and definitions used throughout this manual, and symbols which may appear on equipment. 14.1 Terms and Definitions 14.2 Visual Symbols TERMS, DEFINITIONS, AND SYMBOLS...
InnoWave PCF Sonic Irrigator Operator Manual 14.1 Terms and Definitions The terms, as defined below, may appear throughout this manual. Accessories Optional devices or fittings (e.g., additional instrument basket or seismic design) that can be used with, or extend the functionality of equipment.
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InnoWave PCF Sonic Irrigator Operator Manual Chamber Larger cavity within equipment where instruments are washed. Also refered to as "tank". Chemical A water-soluble substance used to assist cleaning during a wash cycle. Often refers to the use of "Detergent". Chemical enclosure A storage area within the body of the sonic irrigator.
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InnoWave PCF Sonic Irrigator Operator Manual Degas, Degassing An action where sonics are used to remove dissolved gases of water in tank. Degassing is normally performed at beginning of main wash cycle stage. Detergent A water-soluble cleansing agent which combines with impurities and dirt to make them more soluble.
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InnoWave PCF Sonic Irrigator Operator Manual Flush, Flushing The action of pushing washing fluids through a hollow vessel or instrument. Instrument Miscellaneous medical tools, such a as clamps, scissors, spreaders picks, and items used for keyhole surgery, that require cleaning before reuse.
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InnoWave PCF Sonic Irrigator Operator Manual Lumen A hollow channel or narrow cavity. May refer to feature within medical instuments and/or connectors to such intruments. Manifold Normally located at interior corners of basket, a manifold provides connection to flushing feature of equipment.
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InnoWave PCF Sonic Irrigator Operator Manual Processing A general term used to describe a series of actions intended to clean instruments, or prepare intsruments for secondary cleaning using other equipment. Program A sequence of actions that equipment performs in order to clean instruments. Also referred to as a "cycle".
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InnoWave PCF Sonic Irrigator Operator Manual Sonic irrigation The use of ultrasonic waves to dislodge contaminants from instrument surfaces, and flushing to remove debris from instruments. Supervisor An operator who is able to access Supervisor Menu by using a valid supervisor identification number.
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InnoWave PCF Sonic Irrigator Operator Manual Xi/X instruments A range of instruments made by Intuitive 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.
InnoWave PCF Sonic Irrigator Operator Manual 14.2 Visual Symbols The following symbols may appear on the equipment: Table 14.1 Visual Symbols Symbol Description UL listed mark Certifies that equipment meets requirements and standards of Underwriters Laboratories (UL). Accompanied by UL listing reference.
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InnoWave PCF Sonic Irrigator Operator Manual Table 14.1 Visual Symbols (continued) Symbol Description Manufacturer Catalog Number Accompanied by manufacturer code unique to equipment model. Manufacturer Serial Number Accompanied by manufacturer code unique to this equipment. Medical Device Indicates that this equipment is a medical device, as defined by Medical Device Regulations (MDR) 2017/745.
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InnoWave PCF Sonic Irrigator Operator Manual Appendices Appendix A: Service Record Appendix B: Training Records Appendix C: Decontamination Certificate Appendix D: Operator and Supervisor Authorization Codes APPENDICES...
Operator Manual InnoWave PCF Sonic Irrigator Appendix A: Service Record The table below should be updated whenever this equipment is serviced, and made available in event of warranty claim or breakdown repair. 6-Month Service 12-Month Service Serviced by Serviced by...
InnoWave PCF Sonic Irrigator Operator Manual Appendix B: Training Records The table below can be used for keeping training records. Date Name Title of training Signature of trainer APPENDICES...
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InnoWave PCF Sonic Irrigator Operator Manual Appendix C: Decontamination Certificate IMPORTANT A full decontamination MUST be done when shipping equipment to supplier for any reason, including returns for repair or servicing. If a completed Decontamination Certificate is not visible on outside of shipping crate, courier and/or supplier CAN REFUSE to accept item(s).
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InnoWave PCF Sonic Irrigator Index Classifications 132 Compliance 20 Contact details i, 124 Accessories ii, 6, 26, 87 Applied standards ii, 18 Audio 132 Date of manufacture 18, 146 Decontamination Certificate 85, 87, 153 full decontamination 82, 84-85, 129, 153...
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InnoWave PCF Sonic Irrigator cleaning (weekly) 82 Manufacturer information 18 Menu main menu 23, 92, 99-100 Features of equipment ii, 14 supervisor menu ii, 24, 26, 84, 87, 91- 94, 99-100, 104, 126, 128 Hose clamps 57 PIN number operator codes 155...
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InnoWave PCF Sonic Irrigator slipping hazard 5 Serial number 18, 24, 111, 147, 153 Servicing 2, 9, 27, 68, 81, 85, 89, 153 service record 89, 150 Ultrasonic system 132 service schedule 89 Units Specification 131-132 metric or US units setting ii, 92, 99...
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