Steris InnoWave PCF Sonic Irrigator User manual

InnoWave™ PCF Sonic Irrigator
Operator Manual
ENGLISH

Publication Details
Publication Number DOC04440-EN
Publication Title InnoWave PCF Sonic Irrigator Operator Manual
Models Covered IWPCF
All model numbers prefixed with IW531
DISCLAIMER
Any translation of the original English document is for information purposes only.
In case of a discrepancy, the original English document will prevail.
Contact Details
STERIS Corporation, 5960 Heisley Rd, Mentor, OH 44060, USA
Telephone: [phone]
www.STERIS.com
COPYRIGHT © 2022 STERIS. ALL RIGHTS RESERVED.
REPRODUCTION OF THIS MANUAL IN ANY MEDIUM WITHOUT THE EXPRESS PERMISSION OF STERIS
IS PROHIBITED.
LIMITED RIGHTS NOTICE TECHNICAL DOCUMENTATION/DATA:
This technical manual shall not, without the written permission of STERIS be either (a)used, released,
disclosed, or reproduced in whole or in part or (b)used in whole or in part for manufacture except that
(i)such release, disclosure or use is necessary for emergency 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.
PUBLICATION DETAILS i
InnoWave PCF Sonic Irrigator Operator Manual

Revision History
Revision Date Summary
1 12 Jan 2017 First release.
2 15 Mar 2017 Updated detergents.
3 10 Oct 2017 Updated daily checks.
4 18 Jan 2018 Updated basket size, seismic, drain cooling, daily checks, supervisor limits.
5 07 Nov 2018 Update daily/weekly checks.
6 29 Nov 2018 Document formatting.
7 08 Feb 2019 Labeling and manufacturing detail change.
8 21 Aug 2019 Manufacturing detail change.
9 10 Oct 2019 Major revision. See Changes since previous edition within publication for
details.
10 17 Jun 2020 See Changes since previous revision within publication for details.
11 08 Mar 2021 Added sonic indicators to Troubleshooting. Corrected item numbers in
Accessories and Parts List. Updated Applied Standards. Correction to da Vinci
Disinfection Cycle Program parameters. Correction to Open Programs
parameters. Correction to Decontamination Program parameters. Corrected
sequence of tasks in Rewash Feature. Corrected statements on thermal
disinfection in Intended Purpose of Equipment, and Performance. Updated
Power Consumption information. Updated Maximum Drain Flow Rate.
Removed incorrect heat emission statement from Environmental Performance.
Corrected 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 Port added to Wash
Cycle Logs (renamed from Downloading Wash Cycle Logs). General
Equipment Issues and Wash Cycle Issues rewritten with Troubleshooting
Equipment Behavior (renamed from Troubleshooting Equipment
Performance). Equipment Features revised. Applied Standards revised.
Basket Selection revised. Cleaning and Inspection Before Every Wash Cycle
revised and moved to Performing a Wash Cycle. Wash Cycle Stages revised.
Functions Available Through the Supervisor Menu revised. Viewing Locked
Wash Program Parameters, and Viewing or Editing Open Wash Program
Parameters combined into Viewing and Editing Wash Program Parameters.
Individual wash program parameters tables combined into Wash Programs
Default Parameters. Diagnosing Error Codes revised. Added additional
paragraph and step to describe using abort to empty tank during rewash
cycles. Waste water cooling added to Water Consumption.
ii REVISION HISTORY
InnoWave PCF Sonic Irrigator Operator Manual

InnoWave PCF Sonic Irrigator Operator Manual
TABLEOFCONTENTS iii
Table of Contents
Publication Details i
Revision History ii
Safety Information
1.1 Safety Precautions 2
1.2 Personal Protective Equipment 9
1.3 Transportation and Storage 9
1.3.1 Lifting 9
1.3.2 Storage Markings 9
1.3.3 Environmental Conditions 10
1.4 Independent Monitoring 10
1.5 Recommended Operator Training 11
General Information
2.1 Intended Purpose of Equipment 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
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
Preparing Chemicals
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
4.5.1 Detergent Pump Priming 29

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InnoWave PCF Sonic Irrigator Operator Manual
4.5.2 Lubricant Pump Priming 30
Using Instrument Baskets
5.1 Basket Selection 32
5.2 Basket Care and Inspection 33
5.2.1 Basket Frame — Care 33
5.2.2 Basket Manifolds — Care 33
5.2.3 Basket Flush Ports — Care 34
5.3 Removing the Basket from the Tank 35
5.4 Standard Basket 36
5.4.1 Standard Basket — Loading General Instruments 37
5.4.2 Standard Basket — Loading Cannulated Instruments 38
5.4.3 Standard Basket — Unloading 42
5.5 Si Basket 43
5.5.1 Si Basket — Loading 44
5.5.2 Si Basket — Unloading 46
5.6 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 Wash Cycle
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
Maintenance
7.1 Important Safety Information 80

7.2 Daily Cleaning and Inspection 81
7.3 Weekly Cleaning and Inspection 82
7.4 Checking the Time and Date Settings 83
7.4.1 Time Setting Adjustment 83
7.4.2 Date Setting Adjustment 83
7.5 Performing a Weekly Full Decontamination 84
7.6 Performing a Full Decontamination After Standing Idle 85
7.7 Accessories and Replacement Parts 87
7.8 Equipment Servicing 89
The Supervisor Menu
8.1 Functions Available Through the Supervisor Menu 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
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 USB Flash Drive 110
Troubleshooting
11.1 Diagnosing Error Codes 114
11.2 Troubleshooting Equipment Behavior 121
11.2.1 General Equipment Issues 121
11.2.1.1 Sonic irrigator does not power-up. 121
11.2.1.2 Basket does not release from the tank. 121
11.2.1.3 Basket does not dock into the tank. 122
11.2.1.4 Water leaking from the lid area. 122
11.2.1.5 Excessive fill time. 123
11.2.1.6 Excessive drain time. 123
11.2.2 Wash Cycle Issues 123
TABLEOFCONTENTS v
InnoWave PCF Sonic Irrigator Operator Manual

vi TABLEOFCONTENTS
InnoWave PCF Sonic Irrigator Operator Manual
11.2.2.1 Check Chemical appears on the display. 123
11.2.2.2 Instruments not clean after wash cycle. 123
11.2.2.3 Sonic and/or cleaning efficacy indicator(s) 124
Wash Programs
12.1 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
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 Environmental Performance 136
Terms, Definitions, and Symbols
14.1 Terms and Definitions 138
14.2 Visual Symbols 146
Appendices
Appendix A: Service Record 150
Appendix B: Training Records 151
Appendix C: Decontamination Certificate 153
Appendix D: Operator and Supervisor Authorization Codes 155
Index 157

SAFETY INFORMATION 1
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.
This chapter contains important safety information about the equipment.
Read this entire manual before attempting to install, operate, or perform any maintenance on
the equipment. Make sure all personnel understand the contents of this manual.
This manual contains important information on the proper use and maintenance of this
equipment. 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 important to protect health and safety of personnel and should
be retained in a conveniently accessible area for quick reference.
CHAPTER 1
InnoWave PCF Sonic Irrigator Operator Manual

1.1 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.
Strictly following these safety precautions enhances your ability to safely and
effectively utilize the equipment and helps avoid improper operation or
maintenance that may damage the equipment or render it unsafe. It is important to
understand that these safety precautions are not exhaustive. 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 or an explosion.
lUse ONLY water or water-detergent mix in the tank.
lNEVER use flammable or combustible materials, gases, or cleaning
liquids.
WARNING — Breathing hazard
Some cleaning solutions emit harmful vapors.
lMake sure that the area is well ventilated. Use cleaning solutions ONLYin
well-ventilated areas.
lDONOT inhale vapors.
lDONOT permit solution vapors to exceed maximum allowable
concentrations.
2 SAFETY INFORMATION
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.
lDONOT remove any panels or attempt to gain access to the interior of the
electrical cabinet.
lRefer servicing and repair to qualified personnel only. It is expected that
any person servicing or repairing the equipment will be a competent
technician with an understanding of electrical safety, and the risks of
working with electrical appliances that use water.
lBefore inspecting or replacing any part, switch off and lock out, or
disconnect the electrical supply at an external isolation point. Electrical
shock can cause serious injury.
lDONOT expose the equipment to unnecessary moisture.
lALWAYS make sure that all external surfaces are dried after every wash
cycle.
lWhen 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.
lDONOT get chemicals in eyes, on skin, or attempt to consume orally.
lRead 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.
lWear appropriate Personal Protective Equipment (PPE) whenever
handling chemicals or servicing the chemical injection pumps and lines.
This should include plastic gloves, goggles or a full-face visor, and a
disposable plastic apron.
lGuidelines to be followed in case of emergency caused by chemical
contact should be displayed prominently near the equipment.
SAFETY INFORMATION 3
InnoWave PCF Sonic Irrigator Operator Manual

WARNING — Burn hazard
Temperatures within the equipment can reach +98 °C (+208 °F) during and
after operation.
lTake care when opening the lid at the end of a wash cycle.
lAllow sufficient time for items to cool before handling, cleaning, or
commencing maintenance procedures.
lWhen 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.
WARNING — Personal injury and/or equipment damage hazard
lONLY the equipment manufacturer or service personnel approved by the
manufacturer may make repairs and adjustments to this equipment.
lThis equipment should ONLY be installed, moved, or relocated by a
manufacturer-approved service technician or an approved installer.
lMaintenance 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.
lScheduled preventive maintenance, as described within the service
manual, is required for safe and reliable operation of this equipment.
Contact the supplier to schedule preventive maintenance.
lFailure to perform periodic inspections of the equipment could result in
serious personal injury or equipment damage.
lDONOT wear loose fitting clothing, neck ties, or jewelry that could
become entangled in moving parts.
lNEVER reach into the wash tank when the equipment is operating.
lALWAYS use the baskets to process instruments.
4 SAFETY INFORMATION
InnoWave PCF Sonic Irrigator Operator Manual

WARNING — Slipping hazard
Fluids spilled on floors can cause a slipping hazard.
lImmediately wipe up any spilled liquid or condensation.
lIf spills or leaks contain chemicals, ALWAYS follow the safety precautions
and handling procedures on the chemical label and/or the Safety Data
Sheet (SDS).
WARNING
lALWAYS wear appropriate Personal Protective Equipment (PPE)
whenever removing baskets from the carrier and tank.
lIn instances of body contact with chemical, ALWAYS follow emergency
procedure given in that chemical's SDS or call emergency services.
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.
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) at any stage.
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.
SAFETY INFORMATION 5
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.
CAUTION — Chemical hazard
Since the equipment contains heating devices, use of substances or
chemicals other than those specified in this manual may be hazardous.
lALWAYS read the 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.
lALWAYS check the expiry date on chemical containers before use.
lFor correct disposal of chemical containers, refer to the manufacturer
instructions and local regulations.
CAUTION
Using non- recommended chemicals, accessories, and replacement parts
may cause damage to the equipment and could void both your warranty and
guarantee of performance.
6 SAFETY INFORMATION
InnoWave PCF Sonic Irrigator Operator Manual

CAUTION — Equipment damage
lThis equipment should NOT be used for any purpose other than that
defined by the manufacturer as a sonic irrigator.
lNEVER place items or person(s) on the lid as this may result in damage to
the equipment.
lDONOT drop items into the wash tank as this could damage the
ultrasonic transducers.
lDONOT place items directly into the wash tank or allow them to contact
the tank sides.
lNEVER scratch the tank walls. This can increase cavitation erosion.
lDONOT load the basket with instruments pointing towards the lid.
lDONOT overload the basket.
lWhen choosing a detergent, select one with a low chloride content.
Detergents with high chloride content can be harmful to stainless steel.
lRepeated fuse blows, or circuit breaker trips indicate a short circuit or
overload. Have a fully-trained service technician diagnose and remedy the
situation.
lUse non-abrasive cleaners when cleaning the equipment. Follow
directions on the container and rub in a back-and-forth motion, in same
direction as the surface grain. Abrasive cleaners damage stainless steel.
Cleaner rubbed in circular motion or applied with a wire brush or steel
wool will scratch and dull stainless steel.
lAvoid impacting the display with instruments or the basket during loading
and unloading.
lThe use of non-recommended chemicals, accessories, or replacement
parts may cause damage to the equipment and could void both the
warranty and the guarantee of performance.
SAFETY INFORMATION 7
InnoWave PCF Sonic Irrigator Operator Manual

CAUTION — Basket Loading
lThe weight of a basket loaded with instruments MUST NOT exceed 20kg
(44lb).
lInstruments should be distributed evenly around the basket.
lAvoid instruments contacting each other if possible.
lPlace instruments individually into the basket. Avoid tipping or dropping
multiple instruments from a bin into the basket.
lAlways process instruments in multiple wash cycles rather than load a
basket with many instruments contacting each other, even if this is within
the basket weight loading capacity.
CAUTION — Basket Manual Handling
If a loaded basket cannot be lifted and carried comfortably by one 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.
CAUTION — Instrument care
lAlways confirm compatibility with instrument manufacturer.
lAlways follow manufacturer instructions if processing instruments with
special characteristics, e.g. fiber optics or rigid optics.
lAlways follow manufacturer instructions when processing instruments.
lAlways disassemble instruments that are designed to be taken apart,
open box-jointed instruments, and open taps on cannulated instruments.
lVisually inspect instruments and luer hoses after reprocessing. If any
instruments are detached from hoses, or hoses appeared ruptured,
instruments should be reprocessed. Dispose of any ruptured hoses
immediately.
8 SAFETY INFORMATION
InnoWave PCF Sonic Irrigator Operator Manual

1.2 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
1.3 Transportation and Storage
Make sure package marking 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 information.
SAFETY INFORMATION 9
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
(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 Manual

1.5 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
sections of this manual:
lSafety Information on page1
lGeneral Information on page13
lPreparing Chemicals on page25
lUsing Instrument Baskets on page31
lPerforming a Wash Cycle on page67
lMaintenance on page79
lTroubleshooting on page113
Training should be reviewed regularly, and training records kept for all operators.
See Training Records on page151.
SAFETY INFORMATION 11
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InnoWave PCF Sonic Irrigator Operator Manual