Steris Innowave Ultra & Ultra+ Sonic Irrigators Operating instructions

InnoWave™ Ultra+ Sonic Irrigator

Operator Manual

ENGLISH

Publication Details

Publication Number DOC04442-EN (09)

Publication Title InnoWave Ultra+ Sonic Irrigator Operator Manual

Models Covered IWULTRAPL

All model numbers prefixed with IW522

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 Ultra+ Sonic Irrigator Operator Manual

Revision History

Revision Date Summary

1 06 Sep 2017 First release.

2 18 Dec 2017 Seismic Kit in chapter 2 under Installation Requirements and chapter 5 under

General Specifications. Cabinet in chapter 2 under Additional Accessories.

Cabinet Instruction in chapter 6 as Cabinet Instructions.

3 29 Nov 2018 Document formatting only.

4 12 Feb 2018 Labeling and manufacturing address change.

5 19 Aug 2019 Manufacturing Information change.

6 23 Oct 2019 Major revision.

7 04 Jun 2020 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

or editing wash programs split into 2 topics: Viewing wash program parameters,

and Editing wash program parameters and both topics rewritten. Setting up a

rewash cycle removed. Downloading logs to USB renamed to Downloading logs

to a USB flash drive and rewritten. New chapter on Wash programs. New chapter

on Rewash feature. Wash programs removed from Specification.

ii

InnoWave Ultra+ Sonic Irrigator Operator Manual

Revision Date Summary

8 18 May 2021 Added sonic indicators to Troubleshooting. Updated Applied Standards. Created

new chapter on Using the Touchscreen Display and moved topics associated with

display from Performing a Wash Cycle to here. Updated Cleaning Before Every

Wash Cycle, Daily Cleaning and Inspection, and On Completion of a Rewash

Cycle. Corrected Supervisor Authorization Code in Appendix D. Updated

Diagnosing Error Codes. Corrected Site Drain Requirements: Capacity. Corrected

Performance: Ultrasonic System transducer operating range. Removed incorrect

heat emission statement. Corrected Rewash Cycle screens appearing at end of

wash. Updated Terms and Definitions. Instruction on checking and adjusting time

and date added to Maintenance. Updated description of overflow hose in

Accessories and Parts. Corrected stated frequency range of ultrasonic system,

and irrigation system flow rate in Performance. Added note on water temperature

increase in Viewing or Editing Unlocked Wash Programs. Updated Models

Covered and Electrical Supply to include 110 V 50 Hz and 230 V 60 Hz models.

9 28 Jul 2023 Added Authorized Representative in the European Union to General Information.

Updated Applied Standards. Added Basket Care and Inspection to Using the

Instrument Basket. Wash Cycle Logs rewritten. Troubleshooting rewritten.

Additional content in Supervisor Menu describing units of measure. Minimum

humidity in Environmental Conditions changed to 0% (from 30%). Symbols

Glossary updated to include CH-Rep and UKCA markings.

iii

InnoWave Ultra+ Sonic Irrigator Operator Manual

iv

This page intentionally blank

InnoWave Ultra+ Sonic Irrigator Operator Manual

TABLEOFCONTENTS v

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

1.3.4 Environmental Conditions 8

1.4 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 Authorized Representative in the European Union 14

2.6 Compliance 14

2.7 Applied Standards 14

2.8 RoHS Requirements 15

2.9 Disposal of equipment 16

Connecting the Equipment

3.1 Unpacking 18

3.2 Enclosed Items Checklist 18

3.3 Ports and Connections on the Equipment 20

3.4 Connecting the Cold Water Hose 21

3.5 Connecting the Hot Water Hose 22

3.6 Connecting the Drain Hose 23

3.7 Connecting the Overflow Hose 26

3.8 Fitting a Recirculation Filter and the Tank Drain Filter 27

3.9 Switching on Electrical Power 28

Using the Touchscreen Display

4.1 The Touchscreen Display 32

4.2 Screen-saver Mode on the Display 32

4.3 Entering an Operator PIN (if enabled) 32

4.4 Menu Navigation 33

4.5 Main Menu Functions 34

4.6 Information on the Display During a Wash Cycle 35

Preparing Chemicals

vi TABLEOFCONTENTS

InnoWave Ultra+ Sonic Irrigator Operator Manual

5.1 Use of Chemicals 38

5.2 Recommended Chemistries — North America Only 39

5.3 Recommended Chemistries — Outside North America 40

5.4 Connecting the Chemical Pickup 40

5.5 Using a Chemical Bottle 41

5.6 Priming the Chemical Pump 42

Using the Instrument Basket

6.1 The Instrument Basket 46

6.2 Basket Care and Inspection 46

6.2.1 Basket Frame — Care 47

6.2.2 Basket Manifolds — Care 47

6.2.3 Basket Flush Ports — Care 47

6.3 Removing the Basket from the Tank 48

6.4 Loading General Instruments 49

6.5 Loading Cannulated Instruments 49

6.6 Docking the Basket into the Tank 52

6.7 Unloading Instruments from the Basket 55

Performing a Wash Cycle

7.1 Cleaning Before Every Wash Cycle 58

7.2 Selecting a Wash Program 59

7.3 Starting a Wash Cycle 60

7.4 Wash Cycle Stages 61

7.5 On Completion of a Wash Cycle 62

7.6 Pausing or Aborting a Wash Cycle 63

7.7 Wash Cycle Errors 64

The Rewash Feature

8.1 Rewash Program Setting 68

8.2 The Rewash Counter 68

8.3 On Completion of a Rewash Cycle 69

Maintenance

9.1 Important Safety Information 72

9.2 Daily Cleaning and Inspection 73

9.3 Weekly Cleaning and Inspection 76

9.4 Checking the Time and Date Settings 76

9.4.1 Time Setting Adjustment 76

9.4.2 Date Setting Adjustment 77

9.5 Performing a Full Decontamination 77

9.6 Accessories and Replacement Parts 79

9.7 Equipment Servicing 80

The Supervisor Menu

10.1 Functions Available Through the Supervisor Menu 82

10.2 Unlocking the Supervisor Menu 82

10.3 Changing the Supervisor PIN 83

10.4 Viewing and Editing Wash Program Parameters 84

10.5 Selecting 12-Hour or 24-Hour Clock Setting 87

10.6 Selecting Metric or US Units for the Display and Cycle Logs 87

10.7 Changing the Language Used by the Display 88

Wash Cycle Logs

11.1 Connecting a Device to the RS232 Port 92

11.1.1 Connecting a Thermal Printer to the RS232 Port 92

11.1.2 Connecting a Data Logging PC to the RS232 Port 92

11.2 Paper Run Out on Printer 93

11.3 Downloading Wash Cycle Logs to a USB Flash Drive 93

Troubleshooting

12.1 Diagnosing Error Codes 96

12.2 Troubleshooting Equipment Behavior 100

12.2.1 General Equipment Issues 100

12.2.1.1 Sonic irrigator does not power-up. 100

12.2.1.2 Wipe Fill Sensor appears on the display. 100

12.2.1.3 Close Lid appears on the display. 100

12.2.1.4 Basket does not release from the tank. 101

12.2.1.5 Basket does not dock into the tank. 101

12.2.1.6 Water leaking from the lid area. 101

12.2.1.7 Excessive fill time. 101

12.2.1.8 Excessive drain time. 102

12.2.2 Wash Cycle Issues 102

12.2.2.1 Check Chemical appears on the display. 102

12.2.2.2 Instruments not clean after wash cycle. 103

12.2.2.3Sonic and/or cleaning efficacy indicator(s) do not confirm expected

equipment performance. 104

Wash Programs

13.1 Wash Program Configuration 106

13.2 Complete Wash Cycle Program 107

13.3 Wash Only Program 108

13.4 Open Programs 109

TABLEOFCONTENTS vii

InnoWave Ultra+ Sonic Irrigator Operator Manual

viii TABLEOFCONTENTS

InnoWave Ultra+ Sonic Irrigator Operator Manual

13.5 Decontamination Program 110

Specification

14.1 Performance 112

14.2 Electrical Supply Requirements 113

14.3 Water Supply Requirements 113

14.4 Site Drain Requirements 114

14.5 Overall Dimensions and Weight 114

14.6 Tank Dimensions and Capacity 114

14.7 Basket Dimensions and Capacity 115

14.8 Languages 115

14.9 Environmental Performance 115

Terms, Definitions, and Symbols

15.1 Terms and Definitions 118

15.2 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

CAUTION — Read this section

Users should read this section entirely before attempting to operate the

equipment described. Users MUST, at all times, observe ALL warnings and

cautions described in 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 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

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 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 — 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.

4 SAFETY INFORMATION

InnoWave Ultra+ Sonic Irrigator Operator Manual

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).

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.

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.

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 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.

6 SAFETY INFORMATION

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 50 kg

(110 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

1.3.4 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)

8 SAFETY INFORMATION

InnoWave Ultra+ Sonic Irrigator Operator Manual

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 Touchscreen Display on page31

lPreparing Chemicals on page37

lUsing the Instrument Basket on page45

lPerforming a Wash Cycle on page57

lMaintenance on page71

lTroubleshooting on page95

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.

SAFETY INFORMATION 9

InnoWave Ultra+ Sonic Irrigator Operator Manual

10

This page intentionally blank

InnoWave Ultra+ Sonic Irrigator Operator Manual

Page is loading ...

Steris Innowave Ultra & Ultra+ Sonic Irrigators Operating instructions

Steris Innowave Ultra & Ultra+ Sonic Irrigators Operating instructions

Related papers

Other documents