Steris Innowave Pro Sonic Irrigator Operating instructions

InnoWave™ Pro Sonic Irrigator

Operator Manual

ENGLISH

Publication Details

Publication Number DOC04441-EN

Publication Title InnoWave Pro Sonic Irrigator Operator Manual

Models Covered IWPRO60

All model numbers prefixed with IW532

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 Pro Sonic Irrigator Operator Manual

Revision History

Revision Date Summary

1 22 Feb 2017 First release

2 05 Apr 2017 Change to Full Decontamination procedure.

3 07 Nov 2017 Copyright text and record of revision table added. General Spec update.

Daily/weekly checks and decontamination updated.

4 28 Nov 2018 Machine label updated. Applied Standards updated. Visual Symbols updated.

Added RoHS Requirements.

5 30 Nov 2018 Document formatting only.

6 12 Feb 2019 Label and manufacturer address update.

7 19 Aug 2019 Manufacturer information update.

8 15 Oct 2019 Electrical supply update.

9 21 May 2020 Manufacturer information update. Serious incidents statement added to

Introduction. Symbols glossary updated. Recommended Chemistries updated.

10 05 Aug 2020 Document reformatting. Metric units added.

11 04 Nov 2021 Completely revised and rewritten.

12 08 Feb 2023 Added Declaration of CE Conformity in General Information. Updated Intended

Intended Purpose of Equipment. Updatedmachine classification in Performance.

Instrument unloading updated. Updated Installation of Equipment. Chapter on

Wash Cycle Logs updated. Added Authorized Representative in EU. Corrected

Recommended Chemicals - North America. Updated Humidity Range in

Environmental Conditions.

ii

InnoWave Pro Sonic Irrigator 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 9

1.3.2 Storage Markings 9

1.3.3 Environmental Conditions 10

1.4 Independent Monitoring 10

1.5 Recommended Operator Training 11

General Information

2.1 Intended Purpose of Equipment 14

2.2 Equipment Features 15

2.3 Equipment Identification 16

2.4 Declaration of CE Conformity 16

2.5 Manufacturer Information 17

2.6 Authorized Representative in the European Union 17

2.7 Compliance 17

2.8 Applied Standards 18

2.9 RoHS Requirements 20

2.10 Installation of Equipment 20

2.11 Disposal of Equipment 20

The Touchscreen Display

3.1 The Touchscreen Display 22

3.2 Screen-saver Mode on the Display 22

3.3 Entering an Operator PIN (if enabled) 22

3.4 Menu Navigation 23

3.5 Main Menu Functions 24

Preparing Chemicals

4.1 Use of Chemicals 26

4.2 Recommended Chemicals — North America Only 27

4.3 Recommended Chemicals — Outside North America 28

4.4 Replacing Chemical Bottles 29

4.5 Priming Chemical Pumps 32

4.5.1 Detergent Pump Priming 32

4.5.2 Lubricant Pump Priming 34

The Carrier

5.1 The Function of the Carrier 36

iv TABLEOFCONTENTS

InnoWave Pro Sonic Irrigator Operator Manual

5.2 Carrier Controls and Information on the Display 37

5.3 Raising and Lowering the Carrier Using the Foot Pedal 38

5.4 Raising and Lowering the Carrier Using the Display 39

5.5 Removing Baskets from the Carrier 41

5.6 Docking Baskets into the Carrier 42

5.7 The Carrier Light Guard 44

5.7.1 Carrier Light Guard Routine Test 45

5.8 The Carrier Safety Edge 46

5.8.1 Carrier Safety Edge Routine Test 47

Instrument Baskets

6.1 The Function of Instrument Baskets 50

6.2 Basket Selection 51

6.3 Basket Care and Inspection 52

6.3.1 Basket Frame — Care 52

6.3.2 Basket Manifolds — Care 53

6.3.3 Basket Flush Ports — Care 53

6.4 The Standard Basket 54

6.4.1 Standard Basket — Loading General Instruments 55

6.4.2 Standard Basket — Loading Cannulated Instruments 56

6.4.3 Standard Basket — Unloading 58

6.5 The Si Multi Basket 60

6.5.1 Si Multi Basket — Instrument Nozzles 60

6.5.2 Si Multi Basket — Attaching and Detaching Nozzles 61

6.5.3 Si Multi Basket — Loading Instruments without Adapters 62

6.5.4 Si Multi Basket — Loading Instruments with Shaft Flush Port 64

6.5.5 Si Multi Basket — Loading Stapler Instruments 67

6.5.6 Si Multi Basket — Unloading Instruments without Adapters 70

6.5.7 Si Multi Basket — Unloading Instruments with Attached Adapters 71

6.6 The Xi Basket 73

6.6.1 Xi Basket — Attaching and Detaching Hoses 73

6.6.2 Xi Basket — Loading 75

6.6.3 Xi Basket — Unloading 78

6.7 The Xi Multi Basket 79

6.7.1 Xi Multi Basket — Attaching and Detaching Hoses 80

6.7.2 Xi Multi Basket — Loading 82

6.7.3 Xi Multi Basket — Unloading 85

Performing a Wash Cycle

7.1 Cleaning and Inspection Before Every Wash Cycle 88

7.2 Selecting a Wash Program 89

7.3 Docking Baskets into the Carrier (semi-automated) 90

7.4 Wash Cycle Stages 92

7.5 Information on the Display During a Wash Cycle 94

7.6 The LED Lid Status Indicator 96

7.7 On Completion of a Wash Cycle 97

7.8 Pausing or Aborting a Wash Cycle 99

7.9 Wash Cycle Errors 100

The Rewash Feature

8.1 Rewash Program Setting 104

8.2 The Rewash Counter 104

8.3 On Completion of a Rewash Cycle 105

Maintenance

9.1 Important Safety Information 110

9.2 Daily Cleaning and Inspection 111

9.3 Weekly Cleaning and Inspection 116

9.4 Checking the Time and Date Settings 117

9.4.1 Time Setting Adjustment 117

9.4.2 Date Setting Adjustment 117

9.5 Performing a Weekly Full Decontamination 118

9.6 Performing a Full Decontamination After Standing Idle 119

9.7 Accessories and Replacement Parts 121

9.7.1 Accessories 121

9.7.2 Replacement Parts 121

9.8 Equipment Servicing 122

9.9 Decontamination for Transportation 122

The Supervisor Menu

10.1 Functions Available Through the Supervisor Menu 124

10.2 Unlocking the Supervisor Menu 125

10.3 Changing the Supervisor PIN 125

10.4 Viewing and Editing Wash Program Parameters 126

10.5 Selecting 12-Hour or 24-Hour Clock Setting 131

10.6 Selecting Metric or US Units for the Display and Cycle Logs 131

10.7 Changing the Language Used by the Display 132

Wash Cycle Logs

11.1 Connecting a Device to the RS232 Port 136

11.1.1 Connecting a Thermal Printer to the RS232 Port 136

11.1.2 Connecting a Data Logging PC to the RS232 Port 136

11.2 Paper Run Out on Printer 136

11.3 Downloading Wash Cycle Logs to a USB Flash Drive 137

Troubleshooting

TABLEOFCONTENTS v

InnoWave Pro Sonic Irrigator Operator Manual

vi TABLEOFCONTENTS

InnoWave Pro Sonic Irrigator Operator Manual

12.1 Diagnosing Error Codes 140

12.2 Troubleshooting Equipment Behavior 147

12.2.1 General Equipment Issues 147

12.2.1.1 Sonic irrigator does not power-up. 147

12.2.1.2 Draining screen shown on unresponsive display. 147

12.2.1.3 Carrier does not move. 147

12.2.1.4 Carrier moves unexpectedly. 148

12.2.1.5 Basket(s) do not release from the carrier. 148

12.2.1.6 Basket(s) do not dock into the carrier. 148

12.2.1.7 Water leaking from the lid area. 149

12.2.1.8 Excessive fill time. 149

12.2.1.9 Excessive drain time. 150

12.2.2 Wash Cycle Issues 150

12.2.2.1 Check Chemical appears on the display. 150

12.2.2.2 Instruments not clean after wash cycle. 151

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

equipment performance. 152

Wash Programs

13.1 Wash Program Configuration 154

13.2 Standard Disinfect Cycle Program 155

13.3 Standard Wash Cycle Program 156

13.4 Decontamination Program 157

Specification

14.1 Performance 160

14.2 Water Consumption 161

14.3 Overall Dimensions and Weight 161

14.4 Tank Dimensions and Capacity 162

14.5 Standard Basket Dimensions and Capacity 162

14.6 Si Multi Basket Dimensions and Capacity 162

14.7 Xi and Xi Multi Basket Dimensions and Capacity 163

14.8 Languages 163

14.9 Environmental Performance 163

Terms, Definitions, and Symbols

15.1 Terms and Definitions 166

15.2 Visual Symbols 175

Appendices

Appendix A: Service Record 178

Appendix B: Training Records 179

Appendix C: Decontamination Certificate 181

Appendix D: Operator and Supervisor Authorization Codes 183

Index 185

TABLEOFCONTENTS vii

InnoWave Pro Sonic Irrigator Operator Manual

viii

This page intentionally blank

InnoWave Pro Sonic Irrigator Operator Manual

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 Pro 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 — Pinching hazard

Pinch points are created during carrier operation.

lALWAYS keep hands clear when opening or closing the carrier.

lIn the unlikely event of an uncontrolled fault, the emergency stop button

can be pushed to cut power to the carrier and other motorized parts.

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.

2 SAFETY INFORMATION

InnoWave Pro Sonic Irrigator Operator Manual

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.

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.

SAFETY INFORMATION 3

InnoWave Pro Sonic Irrigator Operator Manual

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.

WARNING — Burn hazard

Temperatures within the equipment can reach +98 °C (+208 °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 Pro 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.

WARNING

lNEVER open or attempt to open the lid of the equipment during a wash

cycle operation.

lNEVER attempt to start a wash cycle operation with the lid open or

partially open.

lDONOT bypass or attempt to bypass the lid detection and locking

mechanisms in order to commence a cycle with the lid open or partially

open.

SAFETY INFORMATION 5

InnoWave Pro Sonic Irrigator Operator Manual

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.

CAUTION

When standing at the front of the equipment, such as for

the docking and removing of baskets, or when using the

touchscreen display, be careful NOT to inadvertently kick

or press in the foot plate switch at the base of the

machine. The foot pedal should only be used for hands-

free operation of the carrier.

6 SAFETY INFORMATION

InnoWave Pro 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.

NOTE

The emergency stop button is intended for emergency situations only, and is

NOT intended for pausing or aborting a wash cycle in normal operation.

ALWAYS use the touchscreen display to operate the equipment in normal

operation, and for pausing or aborting a wash cycle.

SAFETY INFORMATION 7

InnoWave Pro 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.

IMPORTANT

DONOT hold on to, pull, or push the Safety Light Guard sender and receiver

units on either side of the sonic irrigator. If the laser beam is moved out of

alignment the equipment CANNOT operate, and repair or replacement of the

Safety Light Guard may require the equipment to be returned to the supplier

for repair or replacement.

8 SAFETY INFORMATION

InnoWave Pro Sonic Irrigator Operator Manual

1.3.1 Lifting

Lifting and maneuvering the equipment in the shipping crate must be done with a

pallet truck or forklift truck able to carry a load in excess of 550 kg (1200 lb). Make

sure that the forks are evenly-spaced and central to the equipment as shown below.

IMPORTANT

The foot- operated load pedal and the tank and drain are vulnerable when

lifting equipment. Take care NOT to knock or crush them with the pallet or

forklift forks, as this could result in irreparable damage to the equipment.

1.3.2 Storage Markings

The markings on the shipping crate stipulate the storage conditions and provide

handling information for the equipment.

SAFETY INFORMATION 9

InnoWave Pro 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 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".

10 SAFETY INFORMATION

InnoWave Pro Sonic Irrigator Operator Manual

Page is loading ...

Steris Innowave Pro Sonic Irrigator Operating instructions

Steris Innowave Pro Sonic Irrigator Operating instructions

Related papers

Other documents