Steris InnoWave Pro User manual

InnoWave™ Pro Sonic Irrigator
Operator Manual
ENGLISH

Publication Details
Publication Number DOC04441-EN
Publication Title InnoWave Pro Sonic Irrigator Operator Manual
Models Covered IWPRO60
All model numbers prefixed with IW532
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 © 2021 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.
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InnoWave Pro Sonic Irrigator Operator Manual

Revision History
Revision Date Summary
1 22 Feb 2017 First release
2 05 Apr 2017 Change to Full Decontamination procedure.
3 07 Nov 2017 Copyright text and record of revision table added. General Spec update.
Daily/weekly checks and decontamination updated.
4 28 Nov 2018 Machine label updated. Applied Standards updated. Visual Symbols updated.
Added RoHS Requirements.
5 30 Nov 2018 Document formatting only.
6 12 Feb 2019 Label and manufacturer address update.
7 19 Aug 2019 Manufacturer information update.
8 15 Oct 2019 Electrical supply update.
9 21 May 2020 Manufacturer information update. Serious incidents statement added to
Introduction. Symbols glossary updated. Recommended Chemistries updated.
10 05 Aug 2020 Document reformatting. Metric units added.
11 04 Nov 2021 Completely revised and rewritten.
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InnoWave Pro Sonic Irrigator Operator Manual
TABLEOFCONTENTS iii
Table of Contents
Safety Information
1.1 Safety Precautions 2
1.2 Personal Protective Equipment 8
1.3 Transportation and Storage 8
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 15
2.3 Equipment Identification 16
2.4 Manufacturer Information 16
2.5 Applied Standards 17
2.6 Compliance 18
2.7 RoHS Requirements 18
2.8 Installation of Equipment 18
2.9 Disposal of Equipment 19
The Touchscreen Display
3.1 The Touchscreen Display 22
3.2 Screen-saver Mode on the Display 22
3.3 Entering an Operator PIN (if enabled) 22
3.4 Menu Navigation 23
3.5 Main Menu Functions 24
Preparing Chemicals
4.1 Use of Chemicals 26

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InnoWave Pro Sonic Irrigator Operator Manual
4.2 Recommended Chemicals — North America Only 27
4.3 Recommended Chemicals — Outside North America 28
4.4 Replacing Chemical Bottles 29
4.5 Priming Chemical Pumps 32
4.5.1 Detergent Pump Priming 32
4.5.2 Lubricant Pump Priming 34
The Carrier
5.1 The Function of the Carrier 36
5.2 Carrier Controls and Information on the Display 37
5.3 Raising and Lowering the Carrier Using the Foot Pedal 38
5.4 Raising and Lowering the Carrier Using the Display 39
5.5 Removing Baskets from the Carrier 41
5.6 Docking Baskets into the Carrier 42
5.7 The Carrier Light Guard 44
5.7.1 Carrier Light Guard Routine Test 45
5.8 The Carrier Safety Edge 46
5.8.1 Carrier Safety Edge Routine Test 47
Instrument Baskets
6.1 The Function of Instrument Baskets 50
6.2 Basket Selection 51
6.3 Basket Care and Inspection 52
6.3.1 Basket Frame — Care 52
6.3.2 Basket Manifolds — Care 53
6.3.3 Basket Flush Ports — Care 53
6.4 The Standard Basket 54
6.4.1 Standard Basket — Loading General Instruments 55
6.4.2 Standard Basket — Loading Cannulated Instruments 56
6.4.3 Standard Basket — Unloading 58
6.5 The Si Multi Basket 60
6.5.1 Si Multi Basket — Instrument Nozzles 60
6.5.2 Si Multi Basket — Attaching and Detaching Nozzles 61

6.5.3 Si Multi Basket — Loading Instruments without Adapters 62
6.5.4 Si Multi Basket — Loading Instruments with Shaft Flush Port 64
6.5.5 Si Multi Basket — Loading Stapler Instruments 67
6.5.6 Si Multi Basket — Unloading Instruments without Adapters 70
6.5.7 Si Multi Basket — Unloading Instruments with Attached Adapters 71
6.6 The Xi Basket 73
6.6.1 Xi Basket — Attaching and Detaching Hoses 73
6.6.2 Xi Basket — Loading 75
6.6.3 Xi Basket — Unloading 77
6.7 The Xi Multi Basket 78
6.7.1 Xi Multi Basket — Attaching and Detaching Hoses 79
6.7.2 Xi Multi Basket — Loading 81
6.7.3 Xi Multi Basket — Unloading 84
Performing a Wash Cycle
7.1 Cleaning and Inspection Before Every Wash Cycle 88
7.2 Selecting a Wash Program 89
7.3 Docking Baskets into the Carrier (semi-automated) 90
7.4 Wash Cycle Stages 92
7.5 Information on the Display During a Wash Cycle 94
7.6 The LED Lid Status Indicator 96
7.7 On Completion of a Wash Cycle 97
7.8 Pausing or Aborting a Wash Cycle 99
7.9 Wash Cycle Errors 100
The Rewash Feature
8.1 Rewash Program Setting 104
8.2 The Rewash Counter 104
8.3 On Completion of a Rewash Cycle 105
Maintenance
9.1 Important Safety Information 110
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9.2 Daily Cleaning and Inspection 111
9.3 Weekly Cleaning and Inspection 116
9.4 Checking the Time and Date Settings 117
9.4.1 Time Setting Adjustment 117
9.4.2 Date Setting Adjustment 117
9.5 Performing a Weekly Full Decontamination 118
9.6 Performing a Full Decontamination After Standing Idle 119
9.7 Accessories and Replacement Parts 121
9.7.1 Accessories 121
9.7.2 Replacement Parts 122
9.8 Equipment Servicing 122
9.9 Decontamination for Transportation 123
The Supervisor Menu
10.1 Functions Available Through the Supervisor Menu 126
10.2 Unlocking the Supervisor Menu 127
10.3 Changing the Supervisor PIN 127
10.4 Viewing and Editing Wash Program Parameters 128
10.5 Selecting 12-Hour or 24-Hour Clock Setting 133
10.6 Selecting Metric or US Units for the Display and Cycle Logs 133
10.7 Changing the Language Used by the Display 134
Downloading Wash Cycle Logs
11.1 Recommended USB Flash Drives 138
11.2 Downloading Logs to a USB Flash Drive 138
Troubleshooting
12.1 Diagnosing Error Codes 142
12.2 Troubleshooting Equipment Behavior 149
12.2.1 General Equipment Issues 149
12.2.2 Wash Cycle Issues 152

Wash Programs
13.1 Wash Program Configuration 156
13.2 Standard Disinfect Cycle Program 157
13.3 Standard Wash Cycle Program 158
13.4 Decontamination Program 159
Specification
14.1 Performance 162
14.2 Water Consumption 163
14.3 Overall Dimensions and Weight 163
14.4 Tank Dimensions and Capacity 164
14.5 Standard Basket Dimensions and Capacity 164
14.6 Si Multi Basket Dimensions and Capacity 164
14.7 Xi and Xi Multi Basket Dimensions and Capacity 165
14.8 Languages 165
14.9 Environmental Performance 165
Terms, Definitions, and Symbols
15.1 Terms and Definitions 168
15.2 Visual Symbols 177
Appendices
Appendix A: Service Record 180
Appendix B: Training Records 181
Appendix C: Decontamination Certificate 183
Appendix D: Operator and Supervisor Authorization Codes 185
Index 187
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InnoWave Pro Sonic Irrigator Operator Manual

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 that all personnel understand the
contents of this manual.
This manual contains important information on the proper use and maintenance of
this equipment. All personnel involved in the operation and/or maintenance of this
equipment must carefully review and comply with warnings, cautions, and
instructions contained in this manual. These instructions are important to protect
the health and safety of personnel and should be retained in a conveniently
accessible area for quick reference.
CHAPTER 1
InnoWave Pro 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
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 — Pinching hazard
Pinch points are created during carrier operation.
lALWAYS keep hands clear when opening or closing the carrier.
lIn the unlikely event of an uncontrolled fault, the emergency stop button
can be pushed to cut power to the carrier and other motorized parts.
WARNING — 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.
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InnoWave Pro Sonic Irrigator Operator Manual

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.
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.
SAFETY INFORMATION 3
InnoWave Pro Sonic Irrigator Operator Manual

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.
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 — 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).
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InnoWave Pro Sonic Irrigator Operator Manual

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.
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.
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InnoWave Pro Sonic Irrigator Operator Manual

CAUTION — Instrument Care
lALWAYS confirm compatibility with the instrument manufacturer.
lALWAYS follow the manufacturer instructions if processing instruments
with special characteristics, e.g. fiber optics or rigid optics.
lALWAYS follow the manufacturer instructions when processing
instruments.
lALWAYS open box-jointed instruments.
lALWAYS disassemble instruments that are designed to be taken apart.
CAUTION
When standing at the front of the equipment, such as for
the docking and removing of baskets, or when using the
touchscreen display, be careful NOT to inadvertently kick
or press in the foot plate switch at the base of the
machine. The foot pedal should only be used for hands-
free operation of the carrier.
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InnoWave Pro 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.
NOTE
The emergency stop button is intended for emergency situations only, and is
NOT intended for pausing or aborting a wash cycle in normal operation.
ALWAYS use the touchscreen display to operate the equipment in normal
operation, and for pausing or aborting a wash cycle.
SAFETY INFORMATION 7
InnoWave Pro Sonic Irrigator Operator Manual

1.2 Personal Protective Equipment
When operating or servicing this equipment, the following Personal Protective
Equipment (PPE) must be worn:
Goggles / safety glasses
Protective gloves
Protective clothing
Boots with toe protection
1.3 Transportation and Storage
Make sure the package marking instructions and environmental conditions are
always followed during the transportation and storage of the equipment.
IMPORTANT
DONOT hold on to, pull, or push the Safety Light Guard sender and receiver
units on either side of the sonic irrigator. If the laser beam is moved out of
alignment the equipment CANNOT operate, and repair or replacement of the
Safety Light Guard may require the equipment to be returned to the supplier
for repair or replacement.
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InnoWave Pro Sonic Irrigator Operator Manual

1.3.1 Lifting
Lifting and maneuvering the equipment in the shipping crate must be done with a
pallet truck or forklift truck able to carry a load in excess of 550 kg (1200 lb). Make
sure that the forks are evenly-spaced and central to the equipment as shown below.
IMPORTANT
The foot- operated load pedal and the tank and drain are vulnerable when
lifting equipment. Take care NOT to knock or crush them with the pallet or
forklift forks, as this could result in irreparable damage to the equipment.
1.3.2 Storage Markings
The markings on the shipping crate stipulate the storage conditions and provide
handling information for the equipment.
SAFETY INFORMATION 9
InnoWave Pro 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".
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InnoWave Pro Sonic Irrigator Operator Manual