Steris Innowave Unity Ultrasonic Irrigator Operating instructions

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: 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.

i

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

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

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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 InnoWave™ 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

Steris Innowave Unity Ultrasonic Irrigator Operating instructions

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