Steris InnoWave IW511020 Series User manual

InnoWave™ Eco Ultrasonic Cleaner
Operator Manual
ENGLISH

Publication Details
Publication number DOC08799-EN
Publication title InnoWave Eco Ultrasonic Cleaner Operator Manual
Models covered IWECO2, IWECO5, IW511020-, IW511030-, IW512020-, IW512030-
DISCLAIMER
Any translation of the original English document is for information purposes only.
In case of a discrepancy, the original English document will prevail.
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 Eco Ultrasonic Cleaner Operator Manual

Revision History
Revision Date Summary
1 28 Aug 2018 First release
2 23 Oct 2018 Not released. For internal alignment of revision numbering only.
3 19 Nov 2018 Basket load weights updated. Added tank water temperature. Updated filling of
tank. Various information reorganization.
4 12 Feb 2019 Not issued.
5 20 Feb 2018 Labeling and manufacturing detail change.
6 19 Aug 2019 Manufacturing detail change.
7 08 Oct 2019 Electrical supply voltage addition. Electrical connection updated.
8 06 Jan 2020 Major rewrite and reorganization.
9 03 Jun 2020 Disclaimer added to Publication details. Revised statement on serious incidents
with Safety precautions. Updated Equipment identification. Updated Manufacturer
information. Updated Installing equipment. Updated Emptying tank. Updated
Performing a full decontamination. Updated Accessories and replacement parts.
Updated equipment display examples throughout. Adjusting date and time moved
to Performing a wash cycle, from Installing equipment. Symbols added to Visual
symbols table.
10 10 May 2021 Added sonic indicators to Troubleshooting. Updated Accessories and Parts List.
Updated Applied Standards. Corrected Supervisor Authorization Code in
AppendixD. Updated Diagnosing Error Codes. Removed incorrect heat emission
detail from Environmental Performance. Corrected mismatch in solution quantities
in Performing a Full Decontamination. Updated Accessories and Replacement
Parts. Added IW511020- and IW512020- model variants. Updated Terms and
Definitions. Transportation and Storage moved to Safety Information. Chapter on
Installing the Equipment renamed to Connecting the Equipment. Adjusting the
Date and Time Settings moved to Maintenance.
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InnoWave Eco Ultrasonic Cleaner Operator Manual
TABLEOFCONTENTS iii
Table of Contents
Safety Information
1.1 Safety Precautions 2
1.2 Personal Protective Equipment 7
1.3 Transportation and Storage 7
1.3.1 Storage Markings 7
1.3.2 Environmental Conditions 8
1.4 Recommended Operator Training 8
General information
2.1 Intended Purpose of Equipment 10
2.2 Equipment Features 10
2.3 Equipment Illustrations 11
2.4 Equipment Identification 13
2.5 Manufacturer Information 13
2.6 Applied Standards 14
2.7 Compliance 15
2.8 RoHS Requirements 15
2.9 Disposal of equipment 15
Connecting the Equipment
3.1 Unpacking 18
3.2 Enclosed Items Checklist 18
3.3 Connecting the Drain Hose 19
3.4 Fitting a Filter into the Drain 22
3.5 Switching on Electrical Power 22
Performing a Wash Cycle
4.1 The Touchscreen Display 26
4.1.1 Screensaver Mode on the Display 26
4.1.2 Entering an Operator PIN (if enabled) 26

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InnoWave Eco Ultrasonic Cleaner Operator Manual
4.1.3 Menu Navigation 27
4.1.4 Main Menu Functions 28
4.2 Outline for Performing a Wash Cycle 29
4.3 Removing the Basket from the Tank 30
4.4 Cleaning Before Filling the Tank 31
4.5 Loading Instruments into the Basket 32
4.6 Putting the basket into the tank 34
4.7 Adjusting Wash Program Parameters 35
4.7.1 Tank Water Temperature Limits 36
4.8 Filling the Tank 37
4.9 Adding Chemicals to the Tank 40
4.9.1 Recommended Chemistries — North America Only 41
4.9.2 Recommended Chemistries — Outside North America 42
4.10 Starting a Wash Cycle 42
4.11 Information on the Display During a Wash Cycle 44
4.12 On Completion of a Wash Cycle 45
4.13 Pausing or Aborting a Wash Cycle 46
4.14 Wash Cycle Errors 47
4.15 Emptying the Tank 48
Maintenance
5.1 Important Safety Information 52
5.2 Daily Cleaning and Inspection 53
5.3 Weekly Cleaning and Inspection 55
5.4 Checking the Time and Date Settings 56
5.4.1 Time Setting Adjustment 56
5.4.2 Date Setting Adjustment 57
5.5 Performing a Full Decontamination 58
5.6 Accessories and Replacement Parts 60
5.7 Equipment Servicing 61

The Supervisor Menu
6.1 Functions Available Through the Supervisor Menu 64
6.2 Unlocking the Supervisor Menu 64
6.3 Changing the Supervisor PIN 65
6.4 Changing the Language Used by the Display 67
Downloading Wash Cycle Logs
7.1 Recommended USB Flash Drives 70
7.2 Downloading Logs to a USB Flash Drive 70
Troubleshooting
8.1 Diagnosing Error Codes 74
8.2 Troubleshooting Equipment Performance 76
Specification
9.1 Performance 80
9.2 Electrical Supply Requirement 81
9.3 Site Drain Requirement 81
9.4 Overall Dimensions and Weight 82
9.5 Tank Dimensions and Capacity 82
9.6 Basket Dimensions and Capacity 82
9.7 Languages 83
9.8 Environmental Performance 83
Terms, Definitions, and Symbols
10.1 Terms and Definitions 86
10.2 Visual Symbols 92
TABLEOFCONTENTS v
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vi TABLEOFCONTENTS
InnoWave Eco Ultrasonic Cleaner Operator Manual
Appendices
Appendix A: Service Record 96
Appendix B: Training Records 97
Appendix C: Decontamination Certificate 99
Appendix D: Operator and Supervisor Authorization Codes 101
Index 103

SAFETY INFORMATION 1
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 the health and safety of personnel and
should be retained in a conveniently accessible area for quick reference.
CHAPTER 1
InnoWave Eco Ultrasonic Cleaner 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
lUse only water or water-detergent mix in the tank.
lNever use flammable or combustible materials, gases, or cleaning liquids as
such use could cause a fire or an explosion.
WARNING — Breathing hazard
Some cleaning solutions emit harmful vapors.
lMake sure the area is well ventilated. Only use cleaning solutions in
well-ventilated areas.
lDo not inhale vapors.
lDo not permit solution vapors to exceed maximum allowable concentrations.
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InnoWave Eco Ultrasonic Cleaner Operator Manual

WARNING — Electric shock hazard
To avoid 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 panel 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.
lTo prevent the risk of fire or an electric shock, do not expose the equipment to
unnecessary moisture.
lAlways make sure all external surfaces are dried after every cycle.
lWhen removing the basket, allow fluid to drain into the tank before
moving to the next cleaning station. Excess water spillage may cause an
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 precautions and instructions on the chemical label and in the
Safety Data Sheet (SDS) prior to handling the chemical, changing chemical
containers, or servicing any chemical injection pumps and lines.
lWear appropriate Personal Protective Equipment (PPE) whenever handling
chemicals or servicing 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 the case of an emergency caused by chemical
contact should be prominently displayed near the equipment.
SAFETY INFORMATION 3
InnoWave Eco Ultrasonic Cleaner Operator Manual

WARNING — Burn hazard
lSince temperatures within the equipment can reach +60 °C (+140 °F) during
and after operation, take 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 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
lTo avoid slippery floors, immediately wipe up any spilled liquid or condensation.
lIf spills or leaks contain chemicals, follow safety precautions and handling
procedures on the chemical label and/or the Safety Data Sheet (SDS).
WARNING — Personal injury and/or equipment damage hazard
lOnly the equipment manufacturer or service personnel approved by
manufacturer may make repairs and adjustments to this equipment.
lMaintenance performed by unqualified personnel, or the installation of
unauthorized parts could cause personal injury, result in improper equipment
performance, invalidate the equipment 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 this 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 basket to process instruments.
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InnoWave Eco Ultrasonic Cleaner Operator Manual

WARNING — No user-serviceable parts
No user-serviceable parts inside the equipment. To avoid personal injury, improper
equipment performance, invalidation of the equipment warranty, or other costly
damage, service and repair should only be performed by a 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 to be compatible with the 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 — 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.
lVisually inspect instruments after reprocessing. If any instruments became
detached from the connection tubing during processing, they should be
reprocessed after making sure that the luer connection is firmly re-attached.
SAFETY INFORMATION 5
InnoWave Eco Ultrasonic Cleaner Operator Manual

CAUTION— Equipment damage
lThis equipment should not be used for any purpose other than that defined by
the manufacturer as an ultrasonic cleaner.
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 a 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 the 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.
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InnoWave Eco Ultrasonic Cleaner 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.
1.3.1 Storage Markings
The markings on the shipping crate stipulate the storage conditions and provide handling
information for the equipment.
SAFETY INFORMATION 7
InnoWave Eco Ultrasonic Cleaner Operator Manual

1.3.2 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 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:
l Safety Information on page1
l General information on page9
l Performing a Wash Cycle on page25
l Maintenance on page51
l Troubleshooting on page73
Training should be reviewed regularly, and training records kept for all operators. A form
that can be used for training records is included in Training Records on page97.
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InnoWave Eco Ultrasonic Cleaner Operator Manual

GENERAL INFORMATION 9
General information
This chapter provides general information about the equipment.
2.1 Intended Purpose of Equipment 10
2.2 Equipment Features 10
2.3 Equipment Illustrations 11
2.4 Equipment Identification 13
2.5 Manufacturer Information 13
2.6 Applied Standards 14
2.7 Compliance 15
2.8 RoHS Requirements 15
2.9 Disposal of equipment 15
CHAPTER 2
InnoWave Eco Ultrasonic Cleaner Operator Manual

2.1 Intended Purpose of Equipment
The InnoWave Eco Ultrasonic Cleaner is designed to provide external cleaning (remove
tissue, blood, and other contaminants) from a variety of reusable surgical instruments. The
equipment uses sonic irrigation (ultrasonic cavitation) to clean instruments.
IMPORTANT
If this equipment is used in a manner not specified by manufacturer, the effectiveness
and protection provided by the equipment may be impaired.
2.2 Equipment Features
The InnoWave Eco Ultrasonic Cleaner product family includes 2 model variants. The Eco
10L has a 10- liter (2.6USgal) capacity tank. The Eco 20L has a 20- liter (5.3USgal)
capacity tank.
The operator loads instruments into the basket and places it into the tank. Wash
temperature and wash time can be manually set by the operator using the touchscreen
display. Water and detergent are then added manually by the operator and mixed with the
water in the tank. The operator starts the wash cycle from the display.
If tank fluids are below the target set in the wash program, a heating pad is activated. When
fluids in the tank reach the target temperature, ultrasonics pulse on and off to remove any
dissolved air: this is followed by a period of constant ultrasonics to dislodge material from
instruments. On completion of the wash cycle, instruments are removed from the
equipment for manual rinsing and sterilization.
During the wash cycle, parameters are reported at key stages of the process. The on-board
cycle log can be downloaded to a connected USB flash drive. The equipment is designed to
perform within strict and carefully controlled tolerances. If an unexpected condition occurs
during the wash cycle, the system will abort the cycle and report an error on the display.
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InnoWave Eco Ultrasonic Cleaner Operator Manual

2.3 Equipment Illustrations
The following illustrations identify the main features of the ultrasonic cleaner.
Figure 2.1
Front view with lid in place: 20-liter (5.2-gallon) model shown
GENERAL INFORMATION 11
InnoWave Eco Ultrasonic Cleaner Operator Manual

Figure 2.2
Front view, lid and basket removed: 20-liter (5.2-gallon) model shown
Figure 2.3
Rear view with lid in place: 20-liter (5.2-gallon) model shown
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InnoWave Eco Ultrasonic Cleaner Operator Manual