Steris InnoWave PCF Sonic Irrigator Operating instructions

InnoWave™ PCF Sonic Irrigator

Operator Manual

ENGLISH

Publication Details

Publication Number DOC04440-EN

Publication Title InnoWave PCF Sonic Irrigator Operator Manual

Models Covered IWPCF

All model numbers prefixed with IW531

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.

PUBLICATION DETAILS i

InnoWave PCF Sonic Irrigator Operator Manual

Revision History

Revision Date Summary

1 12 Jan 2017 First release.

2 15 Mar 2017 Updated detergents.

3 10 Oct 2017 Updated daily checks.

4 18 Jan 2018 Updated basket size, seismic, drain cooling, daily checks, supervisor limits.

5 07 Nov 2018 Update daily/weekly checks.

6 29 Nov 2018 Document formatting.

7 08 Feb 2019 Labeling and manufacturing detail change.

8 21 Aug 2019 Manufacturing detail change.

9 10 Oct 2019 Major revision. See Changes since previous edition within publication for

details.

10 17 Jun 2020 See Changes since previous revision within publication for details.

11 08 Mar 2021 Added sonic indicators to Troubleshooting. Corrected item numbers in

Accessories and Parts List. Updated Applied Standards. Correction to da Vinci

Disinfection Cycle Program parameters. Correction to Open Programs

parameters. Correction to Decontamination Program parameters. Corrected

sequence of tasks in Rewash Feature. Corrected statements on thermal

disinfection in Intended Purpose of Equipment, and Performance. Updated

Power Consumption information. Updated Maximum Drain Flow Rate.

Removed incorrect heat emission statement from Environmental Performance.

Corrected Supervisor Authorization Code in Appendix D.

12 11 Apr 2022 New section on The Touchscreen Display. Identifying Features on the

Equipment added to General Information. Basket Care and Inspection added

to Using Instrument Baskets. Selecting 12-Hour or 24-Hour Clock Setting,

Selecting Metric or US Units for the Display and Cycle Logs added to The

Supervisor Menu. Connecting a Device to the RS232 Port added to Wash

Cycle Logs (renamed from Downloading Wash Cycle Logs). General

Equipment Issues and Wash Cycle Issues rewritten with Troubleshooting

Equipment Behavior (renamed from Troubleshooting Equipment

Performance). Equipment Features revised. Applied Standards revised.

Basket Selection revised. Cleaning and Inspection Before Every Wash Cycle

revised and moved to Performing a Wash Cycle. Wash Cycle Stages revised.

Functions Available Through the Supervisor Menu revised. Viewing Locked

Wash Program Parameters, and Viewing or Editing Open Wash Program

Parameters combined into Viewing and Editing Wash Program Parameters.

Individual wash program parameters tables combined into Wash Programs

Default Parameters. Diagnosing Error Codes revised. Added additional

paragraph and step to describe using abort to empty tank during rewash

cycles. Waste water cooling added to Water Consumption.

13 09 Feb 2023 Added Declaration of CE Conformity in General Information. Updated

Intended Purpose of Equipment. Updated machine classification in

Performance. Added Authorized Representative in EU. Updated Humidity

Range in Environmental Conditions.

14 28 Feb 2023 Corrections to wash program names and phrases referring to text on the user

interface.

ii REVISION HISTORY

InnoWave PCF Sonic Irrigator Operator Manual

TABLEOFCONTENTS iii

Table of Contents

Publication Details i

Revision History ii

Safety Information

1.1 Safety Precautions 2

1.2 Personal Protective Equipment 9

1.3 Transportation and Storage 9

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 14

2.3 Identifying Features on the Equipment 15

2.4 Equipment Identification 18

2.5 Declaration of CE Conformity 18

2.6 Manufacturer Information 19

2.7 Authorized Representative in the European Union 19

2.8 Applied Standards 19

2.9 Compliance 21

2.10 RoHS Requirements 21

2.11 Installation of Equipment 21

2.12 Disposal of Equipment 21

The Touchscreen Display

3.1 Purpose of The Touchscreen Display 24

3.2 Screen-saver Mode on the Display 24

3.3 Entering an Operator PIN (if enabled) 24

3.4 Menu Navigation 25

3.5 Main Menu Functions 25

Preparing Chemicals

4.1 Use of Chemicals 28

4.2 Recommended Chemicals — North America Only 28

4.3 Recommended Chemicals — Outside North America 29

4.4 Replacing Chemical Bottles 29

iv TABLEOFCONTENTS

InnoWave PCF Sonic Irrigator Operator Manual

4.5 Priming Chemical Pumps 31

4.5.1 Detergent Pump Priming 31

4.5.2 Lubricant Pump Priming 32

Using Instrument Baskets

5.1 Basket Selection 34

5.2 Basket Care and Inspection 35

5.2.1 Basket Frame — Care 35

5.2.2 Basket Manifolds — Care 35

5.2.3 Basket Flush Ports — Care 36

5.3 Removing the Basket from the Tank 37

5.4 Standard Basket 38

5.4.1 Standard Basket — Loading General Instruments 39

5.4.2 Standard Basket — Loading Cannulated Instruments 40

5.4.3 Standard Basket — Unloading 44

5.5 Si Basket 45

5.5.1 Si Basket — Loading 46

5.5.2 Si Basket — Unloading 48

5.6 Si Multi Basket 49

5.6.1 Si Multi Basket — Si Single-Site Hose Connection 50

5.6.2 Si Multi Basket — Loading Instruments 52

5.6.3 Si Multi Basket — Loading Staplers 54

5.6.4 Si Multi Basket — Unloading 58

5.7 Xi Multi Basket 60

5.7.1 Xi Multi Basket — Loading 60

5.7.2 Xi Multi Basket — Unloading 63

5.8 Maxi Rinse Basket 64

5.8.1 Maxi Rinse Basket — Loading 65

5.9 Docking the Basket into the Tank 66

Performing a Wash Cycle

6.1 Cleaning and Inspection Before Every Wash Cycle 70

6.2 Selecting a Wash Program 71

6.3 Starting a Wash Cycle 72

6.4 Wash Cycle Stages (P1) 73

6.5 Information on the Display During a Wash Cycle 75

6.6 On Completion of a Wash Cycle 76

6.7 Pausing or Aborting a Wash Cycle 78

6.8 Wash Cycle Errors 78

Maintenance

7.1 Important Safety Information 82

7.2 Daily Cleaning and Inspection 83

7.3 Weekly Cleaning and Inspection 84

7.4 Checking the Time and Date Settings 85

7.4.1 Time Setting Adjustment 85

7.4.2 Date Setting Adjustment 85

7.5 Performing a Weekly Full Decontamination 86

7.6 Performing a Full Decontamination After Standing Idle 87

7.7 Accessories and Replacement Parts 89

7.8 Equipment Servicing 91

The Supervisor Menu

8.1 Functions Available Through the Supervisor Menu 94

8.2 Unlocking the Supervisor Menu 95

8.3 Changing the Supervisor PIN 95

8.4 Viewing and Editing Wash Program Parameters 96

8.5 Selecting 12-Hour or 24-Hour Clock Setting 101

8.6 Selecting Metric or US Units for the Display and Cycle Logs 101

8.7 Changing the Language Used by the Display 102

The Rewash Feature

9.1 Rewash Program Setting 106

9.2 The Rewash Counter 106

9.3 On Completion of a Rewash Cycle 107

Wash Cycle Logs

10.1 Connecting a Device to the RS232 Port 110

10.1.1 Connecting a Thermal Printer to the RS232 Port 110

10.1.2 Connecting a Data Logging PC to the RS232 Port 111

10.2 Paper Run Out on Printer 111

10.3 Downloading Wash Cycle Logs to a USB Flash Drive 112

Troubleshooting

11.1 Diagnosing Error Codes 116

11.2 Troubleshooting Equipment Behavior 123

11.2.1 General Equipment Issues 123

11.2.1.1 Sonic irrigator does not power-up. 123

11.2.1.2 Basket does not release from the tank. 123

11.2.1.3 Basket does not dock into the tank. 124

11.2.1.4 Water leaking from the lid area. 124

11.2.1.5 Excessive fill time. 125

11.2.1.6 Excessive drain time. 125

TABLEOFCONTENTS v

InnoWave PCF Sonic Irrigator Operator Manual

vi TABLEOFCONTENTS

InnoWave PCF Sonic Irrigator Operator Manual

11.2.2 Wash Cycle Issues 125

11.2.2.1 Check Chemical appears on the display. 125

11.2.2.2 Instruments not clean after wash cycle. 125

11.2.2.3 Sonic and/or cleaning efficacy indicator(s) 126

Wash Programs

12.1 Wash Program Configuration 128

12.2 Wash Programs Default Parameters 129

12.3 P1: da Vinci Disinfection Program 129

12.4 P2: da Vinci Wash Cycle Program 130

12.5 P3: Standard Instruments Program 130

12.6 P4, P5: Open Programs 130

12.7 P6: Decontamination Program 131

Specification

13.1 Performance 134

13.2 Water Consumption 135

13.3 Power Consumption 135

13.4 Overall Dimensions and Weight 136

13.5 Tank Dimensions and Capacity 136

13.6 Standard Basket Dimensions and Capacity 136

13.7 Si Basket Capacity 137

13.8 Si Multi Basket Capacity 137

13.9 Xi Multi Basket Capacity 137

13.10 Maxi Rinse Basket Capacity 138

13.11 Languages 138

13.12 Environmental Performance 138

Terms, Definitions, and Symbols

14.1 Terms and Definitions 140

14.2 Visual Symbols 148

Appendices

Appendix A: Service Record 152

Appendix B: Training Records 153

Appendix C: Decontamination Certificate 155

Appendix D: Operator and Supervisor Authorization Codes 157

Index 159

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 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 health and safety of personnel and should

be retained in a conveniently accessible area for quick reference.

CHAPTER 1

InnoWave PCF 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.

2 SAFETY INFORMATION

InnoWave PCF 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 PCF Sonic Irrigator Operator Manual

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 — 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 PCF 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

lALWAYS wear appropriate Personal Protective Equipment (PPE)

whenever removing baskets from the carrier and tank.

lIn instances of body contact with chemical, ALWAYS follow emergency

procedure given in that chemical's SDS or call emergency services.

WARNING

If setting up a rewash program for use with instruments contaminated with

blood, it is recommended that the wash temperature is no higher than +35ºC

(+95ºF). High- temperature washes without a pre- wash cycle can leave

clotted blood on instruments and can promote formation of prions, leading to

instrument contamination.

When performing a succession of rewash cycles, repeated sonic activity may

increase the tank water temperature, and care should be taken to not exceed

the recommended limit of +35ºC (+95ºF) at any stage.

WARNING

When error occurs during wash cycle, load may be contaminated and require

reprocessing. Review cycle log to establish if wash cycle completed before

error. If error interrupted wash cycle, repeat cycle to reprocess load. If error

persists use another unit or alternative cleaning process (according to facility

procedure) and contact equipment supplier to have unit serviced.

SAFETY INFORMATION 5

InnoWave PCF Sonic Irrigator Operator Manual

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

Using non- recommended chemicals, accessories, and replacement parts

may cause damage to the equipment and could void both your warranty and

guarantee of performance.

6 SAFETY INFORMATION

InnoWave PCF 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 PCF Sonic Irrigator Operator Manual

CAUTION — Basket Loading

lThe weight of a basket loaded with instruments MUST NOT exceed 20kg

(44lb).

lInstruments should be distributed evenly around the basket.

lAvoid instruments contacting each other if possible.

lPlace instruments individually into the basket. Avoid tipping or dropping

multiple instruments from a bin into the basket.

lAlways process instruments in multiple wash cycles rather than load a

basket with many instruments contacting each other, even if this is within

the basket weight loading capacity.

CAUTION — Basket Manual Handling

If a loaded basket cannot be lifted and carried comfortably by one operator, it

should be treated as a two- person lift, and additional assistance sought.

Alternatively, the basket loading should be revised to reduce the weight of the

loaded basket.

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,

open box-jointed instruments, and open taps on cannulated instruments.

lVisually inspect instruments and luer hoses after reprocessing. If any

instruments are detached from hoses, or hoses appeared ruptured,

instruments should be reprocessed. Dispose of any ruptured hoses

immediately.

8 SAFETY INFORMATION

InnoWave PCF Sonic Irrigator Operator Manual

1.2 Personal Protective Equipment

When operating or servicing the 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 package marking instructions and environmental conditions are always

followed during transport and storage of the equipment.

1.3.1 Lifting

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

pallet truck or forklift truck able to carry a load in excess of 250 kg (550 lb).

1.3.2 Storage Markings

Markings on the shipping crate stipulate the equipment storage conditions and

handling information.

SAFETY INFORMATION 9

InnoWave PCF 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 PCF Sonic Irrigator 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13

lPreparing Chemicals on page27

lUsing Instrument Baskets on page33

lPerforming a Wash Cycle on page69

lMaintenance on page81

lTroubleshooting on page115

Training should be reviewed regularly, and training records kept for all operators.

See Training Records on page153.

SAFETY INFORMATION 11

InnoWave PCF Sonic Irrigator Operator Manual

12

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Steris InnoWave PCF Sonic Irrigator Operating instructions

Steris InnoWave PCF Sonic Irrigator Operating instructions

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