Steris InnoWave IW521020 Series User manual

InnoWave™ Ultra Sonic Irrigator
Operator Manual
ENGLISH

Publication Details
Publication number DOC07203-EN
Publication title InnoWave Ultra Sonic Irrigator Operator Manual
Models covered IWULTRA, IW521020-, IW521035-, IW521036-
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 Ultra Sonic Irrigator Operator Manual

Revision History
Revision Date Summary
1 19 July 2018 Not released. For internal alignment of revision numbering only.
2 19 Nov 2018 Labeling and manufacturing address change.
3 20 Feb 2019 See revision 6 for details of changes.
4 20 Feb 2019 Labeling and manufacturing address change.
5 19 Aug 2019 Manufacturing Information change.
6 08 Oct 2019 Electrical supply voltage addition. Electrical connection updated.
7 03 Jun 2020 Formatting and page layout change. Visual Symbols moved to Terms, Definitions,
and Symbols and new symbols added. Personal Protective Equipment moved to
Safety Information. Recommended Operator Training moved to Safety Information.
Transportation and Storage moved to General Information. Equipment Description
and Ultra Features merged into Equipment Features. Equipment Identification
example label added. Manufacturer Information updated. Chapter on Installing
Equipment rewritten. New chapter on Loading Instruments in Basket. References to
General Instruments replaced by the term Non-Cannulated Instruments. Operation
replaced by new chapter on Performing Wash Cycle. Chapter on Two-instrument
Luer Hoses removed. Routine Maintenance replaced by new chapter on
Maintenance. Full decontamination chapter removed and content moved to
Maintenance. Chapter on Diagnosing Operation Errors replaced by new chapter on
Troubleshooting. New chapter on Terms, definitions, and Symbols. New section
for Appendices, containing Service record, Training Records, Decontamination
Certificate, and Operator Authorization Codes. Index added.
8 06 May 2021 Added sonic indicators to Troubleshooting. Updated Applied Standards.
Transportation and Storage moved to Safety Information. Chapter on Installing the
Equipment renamed to Connecting the Equipment. Chapter on Loading the Basket
renamed to Using the Instrument Basket. Adjusting Date and Time Settings moved
to Maintenance. Removed incorrect heat emission detail from Environmental
Performance. Corrected Supervisor Authorization Code in Appendix D. Revised
Diagnosing Error Codes. Corrected mismatch in solution quantities in Performing a
Full Decontamination. Corrected irrigation system detail in Performance. Corrected
Site Drain Requirements: Capacity. Corrected Performance: Ultrasonic System
transducer operating range. Corrected items listed in Accessories and Replacement
Parts. Corrected capacity and gully pipe details in Site Drain Requirement. Updated
Terms and Definitions. Added IW512020- (110V 50/60Hz) and IW521036- (230V
60Hz) model variants.
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InnoWave Ultra Sonic Irrigator 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 Lifting 7
1.3.2 Storage Markings 7
1.3.3 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 Identification 13
2.4 Manufacturer Information 13
2.5 Applied Standards 14
2.6 Compliance 15
2.7 RoHS Requirements 15
2.8 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 Recirculation Filter into the Tank Drain 22
3.5 Switching on Electrical Power 24
Using the Instrument Basket
4.1 The Instrument Basket 26
4.2 Removing the Basket from the Tank 27
4.3 Loading General Instruments 29

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InnoWave Ultra Sonic Irrigator Operator Manual
4.4 Loading Cannulated Instruments 30
4.5 Unloading Instruments from the Basket 33
Performing a Wash Cycle
5.1 The Touchscreen Display 36
5.1.1 Screensaver Mode on the Display 36
5.1.2 Entering an Operator PIN (if enabled) 37
5.1.3 Menu Navigation 38
5.1.4 Main Menu Functions 39
5.2 Outline for Performing a Wash Cycle 40
5.3 Cleaning Before Filling the Tank 41
5.4 Putting the basket into the tank 43
5.5 Adjusting Wash Program Parameters 45
5.5.1 Tank Water Temperature Limits 47
5.6 Filling the Tank 47
5.7 Adding Chemicals to the Tank 51
5.7.1 Recommended Chemistries — North America Only 52
5.7.2 Recommended Chemistries — Outside North America 52
5.8 Starting a Wash Cycle 52
5.9 Information on the Display During a Wash Cycle 54
5.10 On Completion of a Wash Cycle 55
5.11 Pausing or Aborting a Wash Cycle 57
5.12 Wash Cycle Errors 57
5.13 Emptying the Tank 59
Maintenance
6.1 Important Safety Information 62
6.2 Daily Cleaning and Inspection 63
6.3 Weekly Cleaning and Inspection 65
6.4 Checking the Time and Date Settings 65
6.4.1 Time Setting Adjustment 66

6.4.2 Date Setting Adjustment 67
6.5 Performing a Full Decontamination 68
6.6 Accessories and Replacement Parts 72
6.7 Equipment Servicing 73
The Supervisor Menu
7.1 Functions Available Through the Supervisor Menu 76
7.2 Unlocking the Supervisor Menu 76
7.3 Changing the Supervisor PIN 77
7.4 Changing the Language Used by the Display 79
Downloading Wash Cycle Logs
8.1 Recommended USB Flash Drives 82
8.2 Downloading Logs to a USB Flash Drive 82
Troubleshooting
9.1 Diagnosing Error Codes 86
9.2 Troubleshooting Equipment Performance 88
Specification
10.1 Performance 92
10.2 Electrical Supply Requirement 93
10.3 Site Drain Requirement 93
10.4 Overall Dimensions and Weight 94
10.5 Tank Dimensions and Capacity 95
10.6 Basket Dimensions and Capacity 96
10.7 Languages 96
10.8 Environmental Performance 97
TABLEOFCONTENTS v
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InnoWave Ultra Sonic Irrigator Operator Manual
Terms, Definitions, and Symbols
11.1 Terms and Definitions 100
11.2 Visual Symbols 107
Appendices
Appendix A: Service Record 110
Appendix B: Training Records 111
Appendix C: Decontamination Certificate 113
Appendix D: Operator and Supervisor Authorization Codes 115
Index 117

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 Ultra 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
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 Ultra Sonic Irrigator 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 Ultra Sonic Irrigator 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 Ultra Sonic Irrigator 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 technician 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
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 open any taps on cannulated 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 Ultra 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 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 Ultra 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.
1.3.1 Lifting
Lifting and maneuvering the equipment in the shipping crate must be done as a two-person
lift, or with a pallet truck or forklift truck able to carry a load in excess of 36 kg (79.4 lb).
1.3.2 Storage Markings
The markings on the shipping crate stipulate the storage conditions and provide handling
information for the equipment.
SAFETY INFORMATION 7
InnoWave Ultra 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 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 Using the Instrument Basket on page25
l Performing a Wash Cycle on page35
l Maintenance on page61
l Troubleshooting on page85
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111.
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InnoWave Ultra Sonic Irrigator 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 Identification 13
2.4 Manufacturer Information 13
2.5 Applied Standards 14
2.6 Compliance 15
2.7 RoHS Requirements 15
2.8 Disposal of equipment 15
CHAPTER 2
InnoWave Ultra Sonic Irrigator Operator Manual

2.1 Intended Purpose of Equipment
The InnoWave Ultra Sonic Irrigator is designed to thoroughly clean (remove tissue, blood,
and other contaminants from) a variety of reusable surgical instruments. The equipment
provides sonic irrigation (ultrasonic cavitation) to both the interior and exterior of lumened
instruments. The system also uses lumen flushing to remove debris from inside channels
when instruments are connected to the flush manifold.
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 Ultra Sonic Irrigator is a sonic irrigator with heating elements for the internal
and external cleaning of surgical instruments. The sonic irrigator has cannulated pulse
enhancement (CPE) and can process up to 12 cannulated instruments in a single wash
cycle. A touch-screen display allows the operator to set parameters for the degassing of
water, the wash temperature, and the wash cycle time. An internal memory records wash
performance data for instrument traceability, which can be downloaded to an external USB
flash drive.
Features include; sensors to prevent use with the lid open, a full-tank sensor, temperature
monitoring, program abort, and operation error reporting on the display.
10 GENERAL INFORMATION
InnoWave Ultra Sonic Irrigator Operator Manual

Lid
Figure 2.1 Front view, lid closed
Lid Seal
Lid Magnet
Figure 2.2 Front view, lid open
GENERAL INFORMATION 11
InnoWave Ultra Sonic Irrigator Operator Manual

Supply Cable
Figure 2.3 Rear view, lid closed
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InnoWave Ultra Sonic Irrigator Operator Manual