Steris Innowave Unity Ultrasonic Irrigator Operating instructions

Type
Operating instructions
InnoWaveâ„¢ Unity and Unity 20 Sonic Irrigators
Operator Manual
ENGLISH
Publication Details
Publication Number DOC09889-EN
Publication Title InnoWaveâ„¢ 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: 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 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).
5 28 Jul 2023 Updated Applied Standards. Minimum humidity in Environmental Conditions
changed to 0% (from 30%). Added Basket Care and Inspection to Using the
Instrument Basket. Troubleshooting rewritten. Additional content in Supervisor
Menu describing units of measure. Wash Cycle Logs rewritten. Symbols Glossary
updated to include CH-Rep and UKCA markings. Formatting changes to
Troubleshooting for readability.
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InnoWave Unity & Unity 20 Operator Manual
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 8
1.3 Transportation and Storage 8
1.3.1 Lifting 8
1.3.2 Storage Markings 8
1.3.3 Environmental Conditions 9
1.4 Independent Monitoring 9
1.5 Recommended Operator Training 10
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 Screen Saver Mode on the Display 18
3.3 Entering an Operator PIN (if enabled) 18
3.4 Menu Navigation 19
3.5 Main Menu Functions 19
3.6 Information on the Display During a Wash Cycle 21
Preparing Chemicals
4.1 Use of Chemicals 24
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 Basket Care and Inspection 33
iv TABLEOFCONTENTS
InnoWave Unity & Unity 20 Operator Manual
5.2.1 Basket Frame — Care 33
5.2.2 Basket Manifolds — Care 33
5.2.3 Basket Flush Ports — Care 34
5.3 Removing the Basket from the Tank 35
5.4 Loading General Instruments 36
5.5 Loading Cannulated Instruments 37
5.6 Loading Si/S Robotic Instruments 40
5.7 Loading Xi Robotic Instruments 43
5.8 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 52
6.4 Wash Cycle Stages — Unity 20 53
6.5 On Completion of a Wash Cycle 54
6.6 Pausing or Aborting a Wash Cycle 57
6.7 Wash Cycle Errors 58
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 77
9.3 Changing the Supervisor PIN 77
9.4 Viewing and Editing Wash Program Parameters 78
9.5 Selecting 12-Hour or 24-Hour Clock Setting 82
9.6 Selecting Metric or US Units for the Display and Cycle Logs 82
9.7 Changing the Language Used by the Display 83
Wash Cycle Logs
10.1 Connecting a Device to the RS232 Port 86
10.1.1 Connecting a Thermal Printer to the RS232 Port 86
10.1.2 Connecting a Data Logging PC to the RS232 Port 87
10.2 Paper Run Out on Printer 87
10.3 Downloading Wash Cycle Logs to a USB Flash Drive 88
Troubleshooting
11.1 Diagnosing Error Codes 92
11.2 Troubleshooting Equipment Behavior 98
11.2.1 General Equipment Issues 98
11.2.1.1 Sonic irrigator does not power-up. 98
11.2.1.2 Lid handle does not move to allow lid to open. 98
11.2.1.3 Basket does not release from the tank. 98
11.2.1.4 Basket does not dock into the tank. 99
11.2.1.5 Dock Basket appears on the display. 100
11.2.1.6 Close Lid appears on the display. 100
11.2.1.7 Water leaking from the lid area. 100
11.2.1.8 Excessive fill time. 100
11.2.1.9 Excessive drain time. 101
11.2.2 Wash Cycle Issues 101
11.2.2.1 Check Chemical appears on the display. 101
11.2.2.2 Instruments not clean after wash cycle. 101
11.2.2.3 Sonic and/or cleaning efficacy indicator(s) 102
11.3 Opening the Unity 20 Lid After a Power Failure 102
Wash Programs
12.1 Wash Program Configuration 106
12.2 Complete Wash Cycle Program 106
12.3 Soak Cycle Program 107
12.4 Open Programs 108
12.5 Decontamination Program 109
Specification
13.1 Performance 112
13.2 Water Consumption - Unity 113
13.3 Water Consumption - Unity 20 113
TABLEOFCONTENTS v
InnoWave Unity & Unity 20 Operator Manual
vi TABLEOFCONTENTS
InnoWave Unity & Unity 20 Operator Manual
13.4 Power Consumption 114
13.5 Overall Dimensions and Weight 114
13.6 Tank Dimensions and Capacity 115
13.7 Unity Basket Dimensions and Capacity 115
13.8 Unity 20 Basket Dimensions and Capacity 115
13.9 Languages 116
13.10 Environmental Performance 116
Terms, Definitions, and Symbols
14.1 Terms and Definitions 118
14.2 Visual Symbols 126
Appendices
Appendix A: Service Record 130
Appendix B: Training Records 131
Appendix C: Decontamination Certificate 133
Appendix D: Operator and Supervisor Authorization Codes 135
Index 137
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.
CHAPTER 1
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
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 Unity & Unity 20 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 Unity & Unity 20 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 Unity & Unity 20 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 Unity & Unity 20 Operator Manual
CAUTION — Instrument care
lAlways confirm compatibility with instrument manufacturer.
lAlways follow manufacturer instructions if processing instruments with
special characteristics, e.g. fiber optics or rigid optics.
lAlways follow manufacturer instructions when processing 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.
6 SAFETY INFORMATION
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 and/or equipment damage 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.
SAFETY INFORMATION 7
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.
8 SAFETY INFORMATION
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:
0% 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".
SAFETY INFORMATION 9
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:
lSafety Information on page1
lGeneral Information on page11
lUsing the Touchscreen Display on page17
lPreparing Chemicals on page23
lUsing the Instrument Basket on page31
lPerforming a Wash Cycle on page49
lMaintenance on page65
lTroubleshooting on page91
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131.
10 SAFETY INFORMATION
InnoWave Unity & Unity 20 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 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 Unity & Unity 20 Operator Manual
2.1 Intended Purpose of Equipment
The STERIS InnoWaveâ„¢ Unity Sonic Irrigator is designed to thoroughly clean
(remove tissue, blood, and other contaminants from) a variety of reusable surgical
instruments. Cleaning is achieved through a combination of ultrasonic cavitation
and low- frequency cannulated pulse enhancement (CPE) fluid recirculation to
dislodge and flush away unwanted debris from both the outside and inside surfaces
(hollow instruments only) of items placed in the tank.
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 Unity & Unity 20 sonic irrigator is available in 2 model variations:
lThe Unity has a tank depth of 215.0mm (8.5in.). The Unity basket has 8 flush
ports.
lThe Unity 20 has a tank depth of 253.4mm (10.0in.) and features a safety lock
that prevents the lid opening during wash operations. The Unity 20 basket has
2 spray nozzles and 8 flush ports.
There are three pre- defined wash programs with pre- wash, wash, and rinse
stages. An additional three wash programs can be customized by authorized users.
An optional rewash program can be configured to allow the wash water to be
reused for up to 10 washes.
Tank filling and draining, and the addition of detergent are automatically controlled
according to wash program settings. During a wash cycle, parameters are reported
at key stages of the process. The on-board cycle log can be downloaded onto a
USB flash drive. At the end of a wash cycle, instruments are removed from the unit
for disinfection and sterilization.
A class AB weir overflow is incorporated into the tank design to comply with water
authority back-flow regulations. The unit is designed to perform within strict and
carefully controlled tolerances. If an unexpected condition occurs during wash
cycle, the system will abort the cycle and report an error.
12 GENERAL INFORMATION
InnoWave Unity & Unity 20 Operator Manual
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Steris Innowave Unity Ultrasonic Irrigator Operating instructions

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