Steris Innowave Eco Ultrasonic Cleaner Operating instructions

Category
Measuring, testing & control
Type
Operating instructions
InnoWaveâ„¢ 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.
Contact Details
STERIS Corporation, 5960 Heisley Rd, Mentor, OH 44060, USA
Telephone: 800-548-4873
www.STERIS.com
COPYRIGHT © 2023 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.
11 27 July 2023 Additional content in Supervisor Menu describing units of measure. Applied
Standards updated. Minimum humidity in Environmental Conditions changed to
0% (from 30%). Symbols Glossary updated to include CH-Rep and UKCA
markings. Formatting changes.
ii
InnoWave Eco Ultrasonic Cleaner Operator Manual
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 8
1.3 Transportation and Storage 8
1.3.1 Storage Markings 8
1.3.2 Environmental Conditions 9
1.4 Recommended Operator Training 9
General information
2.1 Intended Purpose of Equipment 12
2.2 Equipment Features 12
2.3 Equipment Illustrations 13
2.4 Equipment Identification 15
2.5 Manufacturer Information 15
2.6 Applied Standards 16
2.7 Compliance 17
2.8 RoHS Requirements 17
2.9 Disposal of equipment 17
Connecting the Equipment
3.1 Unpacking 20
3.2 Enclosed Items Checklist 20
3.3 Connecting the Drain Hose 21
3.4 Fitting a Filter into the Drain 23
3.5 Switching on Electrical Power 24
Performing a Wash Cycle
4.1 The Touchscreen Display 28
4.1.1 Screensaver Mode on the Display 28
4.1.2 Entering an Operator PIN (if enabled) 28
4.1.3 Menu Navigation 29
4.1.4 Main Menu Functions 29
4.2 Outline for Performing a Wash Cycle 31
4.3 Removing the Basket from the Tank 32
4.4 Cleaning Before Filling the Tank 33
4.5 Loading Instruments into the Basket 34
4.6 Putting the basket into the tank 36
4.7 Adjusting Wash Program Parameters 37
4.7.1 Tank Water Temperature Limits 38
4.8 Filling the Tank 39
iv TABLEOFCONTENTS
InnoWave Eco Ultrasonic Cleaner Operator Manual
4.9 Adding Chemicals to the Tank 42
4.9.1 Recommended Chemistries — North America Only 43
4.9.2 Recommended Chemistries — Outside North America 44
4.10 Starting a Wash Cycle 44
4.11 Information on the Display During a Wash Cycle 46
4.12 On Completion of a Wash Cycle 47
4.13 Pausing or Aborting a Wash Cycle 48
4.14 Wash Cycle Errors 49
4.15 Emptying the Tank 50
Maintenance
5.1 Important Safety Information 54
5.2 Daily Cleaning and Inspection 55
5.3 Weekly Cleaning and Inspection 58
5.4 Checking the Time and Date Settings 58
5.4.1 Time Setting Adjustment 59
5.4.2 Date Setting Adjustment 59
5.5 Performing a Full Decontamination 60
5.6 Accessories and Replacement Parts 63
5.7 Equipment Servicing 64
The Supervisor Menu
6.1 Functions Available Through the Supervisor Menu 66
6.2 Unlocking the Supervisor Menu 66
6.3 Changing the Supervisor PIN 67
6.4 Selecting 12-Hour or 24-Hour Clock Setting 69
6.5 Selecting Metric or US Units for the Display and Cycle Logs 69
6.6 Changing the Language Used by the Display 70
Downloading Wash Cycle Logs
7.1 Recommended USB Flash Drives 74
7.2 Downloading Logs to a USB Flash Drive 74
Troubleshooting
8.1 Diagnosing Error Codes 78
8.2 Troubleshooting Equipment Performance 80
Specification
9.1 Performance 84
9.2 Electrical Supply Requirement 85
9.3 Site Drain Requirement 85
9.4 Overall Dimensions and Weight 86
9.5 Tank Dimensions and Capacity 86
9.6 Basket Dimensions and Capacity 86
9.7 Languages 87
9.8 Environmental Performance 87
Terms, Definitions, and Symbols
10.1 Terms and Definitions 90
10.2 Visual Symbols 96
Appendices
Appendix A: Service Record 100
Appendix B: Training Records 101
Appendix C: Decontamination Certificate 103
Appendix D: Operator and Supervisor Authorization Codes 105
Index 107
TABLEOFCONTENTS v
InnoWave Eco Ultrasonic Cleaner Operator Manual
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InnoWave Eco Ultrasonic Cleaner Operator Manual
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
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 Eco Ultrasonic Cleaner 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 Eco Ultrasonic Cleaner Operator Manual
WARNING — Burn hazard
Temperatures within the equipment can reach +60 °C (+140 °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).
4 SAFETY INFORMATION
InnoWave Eco Ultrasonic Cleaner 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.
SAFETY INFORMATION 5
InnoWave Eco Ultrasonic Cleaner 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.
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.
6 SAFETY INFORMATION
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 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 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.
8 SAFETY INFORMATION
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:
0% 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:
lSafety Information on page1
lGeneral information on page11
lPerforming a Wash Cycle on page27
lMaintenance on page53
lTroubleshooting on page77
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101.
SAFETY INFORMATION 9
InnoWave Eco Ultrasonic Cleaner Operator Manual
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InnoWave Eco Ultrasonic Cleaner Operator Manual
GENERAL INFORMATION 11
General information
This chapter provides general information about the equipment.
2.1 Intended Purpose of Equipment 12
2.2 Equipment Features 12
2.3 Equipment Illustrations 13
2.4 Equipment Identification 15
2.5 Manufacturer Information 15
2.6 Applied Standards 16
2.7 Compliance 17
2.8 RoHS Requirements 17
2.9 Disposal of equipment 17
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,
effectiveness and protection provided by equipment may be impaired.
2.2 Equipment Features
The InnoWave Eco Ultrasonic Cleaner product family includes 2 model variants.
The Eco 2.6 GAL has a 10-liter (2.6USgal) capacity tank. The Eco 5.2 GAL 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.
12 GENERAL INFORMATION
InnoWave Eco Ultrasonic Cleaner Operator Manual
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Steris Innowave Eco Ultrasonic Cleaner Operating instructions

Category
Measuring, testing & control
Type
Operating instructions

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