Steris Innowave Ultra & Ultra+ Sonic Irrigators Operating instructions

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: 800-548-4873

www.STERIS.com

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.

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InnoWave Ultra Sonic Irrigator Operator Manual

Revision Date Summary

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.

9 27 Jul 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.

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TABLEOFCONTENTS v

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 Recommended Operator Training 9

General information

2.1 Intended Purpose of Equipment 12

2.2 Equipment Features 12

2.3 Equipment Identification 15

2.4 Manufacturer Information 15

2.5 Applied Standards 16

2.6 Compliance 17

2.7 RoHS Requirements 17

2.8 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 Recirculation Filter into the Tank Drain 23

3.5 Switching on Electrical Power 25

Using the Instrument Basket

4.1 The Instrument Basket 28

4.2 Removing the Basket from the Tank 29

4.3 Loading General Instruments 31

4.4 Loading Cannulated Instruments 32

4.5 Unloading Instruments from the Basket 35

Performing a Wash Cycle

5.1 The Touchscreen Display 38

5.1.1 Screensaver Mode on the Display 38

5.1.2 Entering an Operator PIN (if enabled) 39

5.1.3 Menu Navigation 40

5.1.4 Main Menu Functions 41

5.2 Outline for Performing a Wash Cycle 42

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InnoWave Ultra Sonic Irrigator Operator Manual

5.3 Cleaning Before Filling the Tank 43

5.4 Putting the basket into the tank 44

5.5 Adjusting Wash Program Parameters 46

5.5.1 Tank Water Temperature Limits 48

5.6 Filling the Tank 48

5.7 Adding Chemicals to the Tank 52

5.7.1 Recommended Chemistries — North America Only 53

5.7.2 Recommended Chemistries — Outside North America 53

5.8 Starting a Wash Cycle 54

5.9 Information on the Display During a Wash Cycle 55

5.10 On Completion of a Wash Cycle 56

5.11 Pausing or Aborting a Wash Cycle 58

5.12 Wash Cycle Errors 58

5.13 Emptying the Tank 60

Maintenance

6.1 Important Safety Information 64

6.2 Daily Cleaning and Inspection 65

6.3 Weekly Cleaning and Inspection 67

6.4 Checking the Time and Date Settings 67

6.4.1 Time Setting Adjustment 68

6.4.2 Date Setting Adjustment 69

6.5 Performing a Full Decontamination 70

6.6 Accessories and Replacement Parts 73

6.7 Equipment Servicing 74

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 Selecting 12-Hour or 24-Hour Clock Setting 79

7.5 Selecting Metric or US Units for the Display and Cycle Logs 79

7.6 Changing the Language Used by the Display 80

Downloading Wash Cycle Logs

8.1 Recommended USB Flash Drives 84

8.2 Downloading Logs to a USB Flash Drive 84

Troubleshooting

9.1 Diagnosing Error Codes 88

9.2 Troubleshooting Equipment Performance 90

Specification

10.1 Performance 94

10.2 Electrical Supply Requirement 95

10.3 Site Drain Requirement 95

10.4 Overall Dimensions and Weight 96

10.5 Tank Dimensions and Capacity 97

10.6 Basket Dimensions and Capacity 98

10.7 Languages 98

10.8 Environmental Performance 99

Terms, Definitions, and Symbols

11.1 Terms and Definitions 102

11.2 Visual Symbols 109

Appendices

Appendix A: Service Record 112

Appendix B: Training Records 113

Appendix C: Decontamination Certificate 115

Appendix D: Operator and Supervisor Authorization Codes 117

Index 119

TABLEOFCONTENTS vii

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InnoWave Ultra Sonic Irrigator 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 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

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.

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InnoWave Ultra Sonic Irrigator 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 Ultra Sonic Irrigator 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).

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InnoWave Ultra Sonic Irrigator 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 Ultra Sonic Irrigator Operator Manual

CAUTION — Basket Loading

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.

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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 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 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.

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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:

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

lUsing the Instrument Basket on page27

lPerforming a Wash Cycle on page37

lMaintenance on page63

lTroubleshooting on page87

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113.

SAFETY INFORMATION 9

InnoWave Ultra Sonic Irrigator Operator Manual

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Steris Innowave Ultra & Ultra+ Sonic Irrigators Operating instructions

Steris Innowave Ultra & Ultra+ Sonic Irrigators Operating instructions

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