Steris InnoWave Unity User manual

InnoWave™ Unity and Unity 20 Sonic Irrigators
Operator Manual
ENGLISH

Publication Details
Publication Number DOC09889-EN
Publication Title InnoWave™ Unity & Unity 20 Sonic Irrigators Operator Manual
Models Covered IW523035-, IW523036-, IW523046-, IW523535-, IW523536-, IW523546-
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 Unity & Unity 20 Operator Manual

Revision History
Revision Date Summary
1 02 May 2019 First release
2 05 Aug 2019 Recommended Training moved to Safety Information. General Information
updated. Specification moved to Chapter 9. Installation moved to DOC12354
"InnoWave Unity Installation and Commissioning Manual". Detail added to Loading
of Instruments. Revised Symbols appearing during wash cycle. Maintenance
moved to Chapter 5. Decontamination moved within Maintenance. Terms,
Definitions, and Symbols added to Chapter 10.
3 01 Sept 2020 Unity 20 model variant details added throughout. Disclaimer added to Publication
details. Equipment Identification updated. Manufacturer Information updated.
Recommended Chemicals (outside North America) updated. Chemical intake hose
renamed to chemical pickup. Loading Instrument Basket renamed to Using the
Instrument Basket, and topics expanded. Checks and Maintenance before every
cycle moved to be within Maintenance. On Completion of Wash Cycle rewritten.
Pausing or Aborting Wash Cycle rewritten. Wash Cycle Errors rewritten.
Performing a Full Decontamination updated. Viewing and Editing Wash Program
Parameters rewritten. New chapter on Rewash Feature. Downloading Logs to USB
renamed to Downloading Logs to a USB Flash Drive and rewritten. New chapter on
Wash Programs. Wash Programs removed from Specification. Opening the Unity
20 Lid after a Power Failure added to Troubleshooting. Terms and definitions
updated. Checking the Time and Date Settings added to Maintenance. Dock basket
added to Troubleshooting equipment performance.
4 06 Jun 2021 Added Transportation and Storage details to Safety Precautions. New chapter on
Using the Touchscreen Display. Updated Applied Standards. Corrected procedure
for completion of a rewash cycle. Added note caution on setting long degas and
wash periods within Editing Wash Programs. Added requirement to drain tank in
order to perform Daily Cleaning and Inspection. Corrected disinfectant solution
volume in Performing a Full Decontamination procedure. Added sonic indicators
diagnostics to Troubleshooting Equipment Performance. Soak Cycle program
wash dose corrected. Removed incorrect heat output detail from Environmental
Performance. Updated Terms and Definitions. Corrected supervisor pin detail in
Operator and Supervisor Authorization Codes (Appendix D).
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InnoWave Unity & Unity 20 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 Independent Monitoring 8
1.5 Recommended Operator Training 9
General Information
2.1 Intended Purpose of Equipment 12
2.2 Equipment Features 12
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
Using the Touchscreen Display
3.1 The Touchscreen Display 18
3.2 Screensaver Mode on the Display 18
3.3 Entering an Operator PIN (if enabled) 18
3.4 Menu Navigation 19
3.5 Main Menu Functions 20
3.6 Information on the Display During a Wash Cycle 21
Preparing Chemicals
4.1 Use of Chemicals 24

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4.2 Recommended Chemicals — North America Only 24
4.3 Recommended Chemicals — Outside North America 25
4.4 Replacing the Chemical Bottle 26
4.5 Priming the Chemical Pump 28
Using the Instrument Basket
5.1 The Instrument Basket 32
5.1.1 The Unity Instrument Basket 32
5.1.2 The Unity 20 Instrument Basket 32
5.2 Removing the Basket from the Tank 33
5.3 Loading General Instruments 34
5.4 Loading Cannulated Instruments 35
5.5 Loading Si/S Robotic Instruments 39
5.6 Loading Xi Robotic Instruments 42
5.7 Docking the Basket into the Tank 45
Performing a Wash Cycle
6.1 Selecting a Wash Program 50
6.2 Starting a Wash Cycle 51
6.3 Wash Cycle Stages — Unity 53
6.4 Wash Cycle Stages — Unity 20 54
6.5 On Completion of a Wash Cycle 55
6.6 Pausing or Aborting a Wash Cycle 58
6.7 Wash Cycle Errors 59
The Rewash Feature
7.1 Rewash Program Setting 62
7.2 The Rewash Counter 62
7.3 On Completion of a Rewash Cycle 63

Maintenance
8.1 Important Safety Information 66
8.2 Daily Cleaning and Inspection 67
8.3 Weekly Cleaning and Inspection 69
8.4 Checking the Time and Date Settings 69
8.4.1 Time Setting Adjustment 70
8.4.2 Date Setting Adjustment 70
8.5 Performing a Full Decontamination 71
8.6 Accessories and Replacement Parts 73
8.6.1 Accessories 73
8.6.2 Replacement Parts 74
8.7 Equipment Servicing 74
The Supervisor Menu
9.1 Functions Available Through the Supervisor Menu 76
9.2 Unlocking the Supervisor Menu 76
9.3 Changing the Supervisor PIN 77
9.4 Viewing and Editing Wash Programs 79
9.5 Changing the Language Used by the Display 83
Downloading Wash Cycle Logs
10.1 Recommended USB Flash Drives 86
10.2 Downloading Logs to a USB Flash Drive 86
Troubleshooting
11.1 Diagnosing Error Codes 90
11.2 Troubleshooting Equipment Performance 95
11.3 Opening the Unity 20 Lid After a Power Failure 100
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InnoWave Unity & Unity 20 Operator Manual
Wash Programs
12.1 Wash Program Configuration 102
12.2 Complete Wash Cycle Program 103
12.3 Soak Cycle Program 104
12.4 Open Programs 105
12.5 Decontamination Program 106
Specification
13.1 Performance 108
13.2 Water Consumption - Unity 109
13.3 Water Consumption - Unity 20 109
13.4 Power Consumption 110
13.5 Overall Dimensions and Weight 110
13.6 Tank Dimensions and Capacity 111
13.7 Unity Basket Dimensions and Capacity 111
13.8 Unity 20 Basket Dimensions and Capacity 111
13.9 Languages 112
13.10 Environmental Performance 112
Terms, Definitions, and Symbols
14.1 Terms and Definitions 114
14.2 Visual Symbols 122
Appendices
Appendix A: Service Record 126
Appendix B: Training Records 127
Appendix C: Decontamination Certificate 129
Appendix D: Operator and Supervisor Authorization Codes 131

Index 133
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Operator Manual InnoWave Unity & Unity 20

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 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.
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InnoWave Unity & Unity 20 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 — 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 that 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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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 panel or attempt to gain access to the interior of the
electrical cabinet.
lRefer servicing and repair to a qualified personnel only. It is expected that any
person servicing or repairing the equipment will be a competent technician with
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 electric shock, do not expose the equipment to
unnecessary moisture.
lAlways make sure that all external surfaces are dried after every wash
cycle.
lWhen removing the basket, allow fluid to drain back into the tank before
moving to the next cleaning station. Excess water spillages 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 Unity & Unity 20 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 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
lTo avoid slippery floors, immediately wipe up any spilled liquid or condensation.
lIf spills or leaks contain chemicals, follow the 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 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 basket to process instruments.
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InnoWave Unity & Unity 20 Operator Manual

WARNING - No user-serviceable parts
No user- serviceable parts inside the equipment. 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 — 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 hose is firmly attached.
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InnoWave Unity & Unity 20 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.
WARNING — Personal injury hazard
The Unity 20 basket features 2 nozzles that spray fluids over instruments during the
wash cycle. During normal operation it is not possible to open the lid when the spray
nozzles are operating, however operators are advised not to attempt to open the lid
during the wash cycle, or open the lid rapidly at the end of a wash cycle.
If, at any time it becomes possible to open the lid of a Unity 20 model during a wash
cycle, this should be reported immediately.
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InnoWave Unity & Unity 20 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 185 kg (408 lb).
1.3.2 Storage Markings
The markings on the shipping crate stipulate the storage conditions and provide handling
information for the equipment.
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InnoWave Unity & Unity 20 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 Unity & Unity 20 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:
l Safety Information on page1
l General Information on page11
l Using the Touchscreen Display on page17
l Preparing Chemicals on page23
l Using the Instrument Basket on page31
l Performing a Wash Cycle on page49
l Maintenance on page65
l Troubleshooting on page89
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127.
SAFETY INFORMATION 9
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