InnoWave-Ultra-Plus-User-Manual-DOC04442pdf

InnoWave™ Ultra+ Sonic Irrigator
Operator Manual
ENGLISH
InnoWave Ultra+ Sonic Irrigator Operator Manual
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
COPYRIGHT © 2023 STERIS. ALL RIGHTS RESERVED.
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
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
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
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
TABLE OF CONTENTS v
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
vi TABLE OF CONTENTS
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
Sonic and/or cleaning efficacy indicator(s) do not confirm expected
12.2.2.3
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

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
viii TABLE OF CONTENTS

CHAPTER 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.
SAFETY INFORMATION 1
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.
l Use ONLY water or water-detergent mix in the tank.
l NEVER use flammable or combustible materials, gases, or cleaning
liquids.
WARNING — Breathing hazard

Some cleaning solutions emit harmful vapors.
l Make sure that the area is well ventilated. Use cleaning solutions ONLY in
well-ventilated areas.
l DO NOT inhale vapors.
l DO NOT permit solution vapors to exceed maximum allowable
concentrations.
2 SAFETY INFORMATION
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.
l DO NOT remove any panels or attempt to gain access to the interior of the
electrical cabinet.
l Refer 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.
l Before 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.
l DO NOT expose the equipment to unnecessary moisture.
l ALWAYS make sure that all external surfaces are dried after every wash
cycle.
l When 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.
l DO NOT get chemicals in eyes, on skin, or attempt to consume orally.
l Read 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.
l Wear 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.
l Guidelines 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 +60 °C (+140 °F) during and
after operation.
l Take care when opening the lid at the end of a wash cycle.
l Allow sufficient time for items to cool before handling, cleaning, or
commencing maintenance procedures.
l When 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

l ONLY the equipment manufacturer or service personnel approved by the
manufacturer may make repairs and adjustments to this equipment.
l This equipment should ONLY be installed, moved, or relocated by a
manufacturer-approved service technician or an approved installer.
l Maintenance 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.
l Scheduled 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.
l Failure to perform periodic inspections of the equipment could result in
serious personal injury or equipment damage.
l DO NOT wear loose fitting clothing, neck ties, or jewelry that could
become entangled in moving parts.
l NEVER reach into the wash tank when the equipment is operating.
l ALWAYS use the baskets to process instruments.
WARNING — Slipping hazard

Fluids spilled on floors can cause a slipping hazard.
l Immediately wipe up any spilled liquid or condensation.
l If 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.
l ALWAYS 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.
l ALWAYS check the expiry date on chemical containers before use.
l For correct disposal of chemical containers, refer to the manufacturer
instructions and local regulations.
CAUTION — Instrument Care

l ALWAYS confirm compatibility with the instrument manufacturer.
l ALWAYS follow the manufacturer instructions if processing instruments
with special characteristics, e.g. fiber optics or rigid optics.
l ALWAYS follow the manufacturer instructions when processing
instruments.
l ALWAYS open box-jointed instruments.
l ALWAYS disassemble instruments that are designed to be taken apart.
CAUTION — Equipment damage

l This equipment should NOT be used for any purpose other than that
defined by the manufacturer as a sonic irrigator.
l NEVER place items or person(s) on the lid as this may result in damage to
the equipment.
l DO NOT drop items into the wash tank as this could damage the
ultrasonic transducers.
l DO NOT place items directly into the wash tank or allow them to contact
the tank sides.
l NEVER scratch the tank walls. This can increase cavitation erosion.
l DO NOT load the basket with instruments pointing towards the lid.
l DO NOT overload the basket.
l When choosing a detergent, select one with a low chloride content.
Detergents with high chloride content can be harmful to stainless steel.
l Repeated fuse blows, or circuit breaker trips indicate a short circuit or
overload. Have a fully-trained service technician diagnose and remedy the
situation.
l Use 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.
l Avoid impacting the display with instruments or the basket during loading
and unloading.
l The 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.
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.
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)
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:
l Safety Information on page 1
l General Information on page 11
l Using the Touchscreen Display on page 31
l Preparing Chemicals on page 37
l Using the Instrument Basket on page 45
l Performing a Wash Cycle on page 57
l Maintenance on page 71
l Troubleshooting 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.
CHAPTER 2
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 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
GENERAL INFORMATION 11
2.1 Intended Purpose of Equipment

The InnoWave Ultra+ 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 wash 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 Ultra+ Sonic Irrigator has sonic irrigation and an ability to wash up to
5.0 kg (11.0 lb) of general surgical instruments, and up to 12 cannulated (lumened)
instruments. A touchscreen provides operational control for equipment, and
displays equipment settings and wash cycle progress.
There are three factory-set wash programs with prewash, wash, and rinse stages.
An additional three wash programs can be customized by authorized operators. A
rewash option can be configured to allow the tank fluids to be used for up to 10
washes.
Wash program settings control duration of each stage, temperature of tank fluids,
and quantity of detergent added. During the wash cycle, parameters are reported at
key stages of the process and can be logged on a connected thermal printer or
computer. The on-board cycle log can be copied to an inserted USB flash drive.
A class AB weir overflow is incorporated into the tank design to comply with water
authority back- flow regulations. The equipment is designed to perform within strict
and carefully controlled tolerances. If an unexpected condition occurs during the
wash cycle, the cycle will be aborted and an error reported.
12 GENERAL INFORMATION
2.3 Equipment Identification

The model reference, serial number, and manufacturer information is displayed on
a label attached to the equipment.
InnoWave™ Ultra+
A
Manufactured for:
STERIS Corpora�on
Sonic Irrigator 5960 Heisley Rd
Medisafe UK Ltd.
Unit 7 & 8 Stor�ord Hall
Mentor, OH 44060, USA
Telephone: 800 548 4873 F
B REF IWULTRAPL
Industrial Park, Dunmow Road www.STERIS.com
Bishop’s Stor�ord
Her�ordshire, CM23 5GZ
C SN 0119 12345 00 STERIS Ireland Limited

IDA Business and Technology Park
D 110-127VAC 60Hz Tullamore, County Oﬀaly
! 1.3kW
R35 X865, Ireland
E 2022-04-08
DOC11183 Issue C
C US
UDI MD 2022/04/08
LISTED
LABORATORY EQUIPMENT
(01)05060247263939(11)200212(21)01191234500 E488885 41DN
Figure 2.1 Example of label attached to the equipment
A. Model name
B. Manufacturer's catalog reference (model part number)
C. Manufacturer's unique equipment serial number
D. Electrical power requirement for equipment
E. Date of manufacture
F. Manufacturer name and address
2.4 Manufacturer Information

The manufacturer of this equipment is as follows:
Medisafe UK Ltd
Unit 7 & 8 Stortford Hall Industrial Park
Dunmow Road
Bishop’s Stortford
Hertfordshire
CM23 5GZ, UK
2.5 Authorized Representative in the European Union

The manufacturer's authorized representative within the European Union is as
follows:
STERIS Ireland Limited
IDA Business Technology Park
Tullamore, County Offaly
R35 X865, Ireland
2.6 Compliance
This equipment has been designed to perform within the guidelines recommended
by international decontamination standards. A stringent quality control program
ensures that every machine is manufactured and tested under controlled conditions
to ensure that all products perform identically.
2.7 Applied Standards

Standards that are applicable, subject to regional requirements and model variants
made available in those regions, are shown below.
Table 2.1 Applied Standards

Standard Title
ANSI C63.4-20141 American National Standard for Methods of Measurement of Radio-

Noise Emissions from Low-Voltage Electrical and Electronic
Equipment in the Range of 9 kHz to 40 GHz.
EN 1717:2000 Protection against pollution of potable water in water installations and

general requirements of devices to prevent pollution by back flow.
ISO 13485:2016 Medical devices — Quality management systems.
ISO 14971:2019 Medical devices — Application of risk management to medical

devices.
ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels,
labeling and information to be supplied — Part 1: General
requirements
ISO 15883-1:2006 +AMD1:2014 Washer-disinfectors — Part 1: General requirements, terms and

definitions and tests
1 Complies with FCC and ISED official limits. Testing in accordance with CFR Title 47:
Telecommunication, Part 15 - Radio Frequency Devices, Subpart A - General.
Table 2.1 Applied Standards (continued)

Standard Title
ISO 20417:2021 Medical devices — Information supplied by the manufacturer of

medical devices.
IEC 61010-1:2010+AMD1:2016 Safety requirements for electrical equipment for measurement, control,
and laboratory use — Part 1: General requirements.
UL 61010-1, 3rd Edition May 11 Safety requirements for electrical equipment for measurement, control,
2012, Revised July 19 2019 and laboratory use — Part 1: General requirements.
CAN/CSA-C22.2 Safety requirements for electrical equipment for measurement, control,

No. 61010-1-12 (2012-05), 3rd and laboratory use — Part 1: General requirements.
Edition, with revisions through 2018-
11
IEC 61010-2-040:2020, Ed. 3.0 Safety requirements for electrical equipment for measurement, control,
and laboratory use — Part 2-040: Particular requirements for sterilizers
and washer-disinfectors used to treat medical materials.
EN 61326-1:2020 Electrical equipment for measurement, control and laboratory use.

BS EN/IEC 61326-1:2021 EMC requirements. General requirements.
IEC 62304:2006+AMD1:2015 Medical device software. Software life-cycle processes.
IEC 62366-1:2015+AMD1:2020 Medical devices — Part 1: Application of usability engineering to

medical devices.
2.8 RoHS Requirements

The equipment manufacturer is committed to meeting or exceeding the
requirements of the RoHS CE Marking Directive 2011/65/EC + (EU) 2015/863,
"Restriction of the Use of Certain Hazardous Substances in Electrical and
Electronic Equipment".
2.9 Disposal of equipment

This equipment contains materials which may require disposal through
appropriately licensed and permitted hazardous waste management firms.
The equipment manufacturer is committed to meeting all requirements of the
WEEE Directive 2012/16/EU (Waste Electrical and Electronic Equipment), and is
registered with the "B2B Compliance" Scheme.
Waste electrical and electronic products must not be placed in the general refuse
but collected separately. Separately collected WEEE products are to be sent to an
approved recycling or disposal operators for safe recycling, recovery or reuse.
CHAPTER 3
Connecting the Equipment

Before the sonic irrigator can be operated, it must be unpacked and connected to site water
supplies and a site drain using the enclosed items. If the equipment owner requires assistance
in connecting the sonic irrigator to the site water supplies and site drain, this should be sought
from the supplier.
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
CONNECTING THE EQUIPMENT 17

3.1 Unpacking
IMPORTANT
When unpacking the equipment, care should be taken at all times and use
only tools and equipment suitable for the task. If in doubt, advice from the
supplier or local representative should be sought before any unpacking is
undertaken.
1. Remove the equipment from the packing crate and remove all external packing.
2. Open the lid and remove any protective packing and loose items from inside the
tank.
3. Make sure all items, as described in the Enclosed Items Checklist below, are
present.
IMPORTANT
Retain all packing materials. If for any reason the equipment needs to be
returned to the supplier, the original crate and packing materials should be
reused.
3.2 Enclosed Items Checklist

Make sure that items required for connecting and using the equipment are all
enclosed. Enclosed items are listed in the table below.
Table 3.1 Enclosed Items
Item Image Description Qty
1 Instrument organizer 1
2 Luer hose pack of 12
18 CONNECTING THE EQUIPMENT

3 Distal connectors, 4 sizes pack of 10
4 Tubing Y connector pack of 6
5 Chemical pickup 1
6 Water inlet hose with blue indicator 1
7 Water inlet hose, stainless steel 1
8 Overflow hose, 50 mm I/D x 1 m 1
9 Hose clamp, 50 to 70 mm 1
10 Drain hose 1
11 Hose clamp, 22 to 32 mm 1
12 1/2 in. x 20 mm hose adapter 1
13 Flat rubber washer 20 mm 1

14 Drain filter 1
15 Disposable recirculation filter pack of 24
9-way pin to pin serial cable, male to

16 1
female
3.3 Ports and Connections on the Equipment

Ports and connections to external services are on the rear of the equipment. Refer
to the illustration below to identify where to connect water supply and drain hoses,
the chemical pickup, an optional thermal printer, and a USB flash drive.
Figure 3.1 Connections and features on rear of equipment
A. Chemical port F. Protection fuses

B. Hot water inlet G. Overflow manifold
C. Cold water inlet
H. USB data port
D. Drain outlet
I. Power switch
E. Printer connection (serial port)

3.4 Connecting the Cold Water Hose
1. Unpack the cold water hose.
2. Make sure the washer is present inside the

elbow connector end of the hose.
3. Identify the cold water inlet. The cold water inlet

is located on the rear of the sonic irrigator and is
labeled COLD 5-30ºC 2-5 BAR.
4. Attach the elbow connector of the cold water
hose to the cold water inlet. Turn the hose nut
clockwise until hand tight on the thread of the
inlet.
5. Connect the free end of the cold water hose to a site cold water supply. Make sure
the hose is not kinked or restricted when the sonic irrigator is in the operating
position.

3.5 Connecting the Hot Water Hose
1. Unpack the hot water hose and the 2 loose

hose washers.
2. Before connecting the hose to the rear of the

sonic irrigator, insert a hose washer into the
end of the hose with an elbow connector.
3. Before connecting the hose to the rear of the

sonic irrigator, insert a hose washer into the
end of the hose with an elbow connector.
4. Identify the hot water inlet. The hot water inlet is located at the rear of the sonic
irrigator and is labeled HOT 50-80ºC 2-5 BAR.

5. Attach the elbow connector of the hose to the hot water inlet. Turn the hose nut
clockwise until hand tight on the thread of the inlet. Use a wrench to tighten by 1/4
turn to make water-tight. DO NOT OVER-TIGHTEN.
6. Attach the free end of the hot water hose to a site hot water supply. Make sure a
washer is inserted in the hose connection before attaching to the site source. Make
sure the hose is not kinked or restricted when the sonic irrigator is in the operating
position.
3.6 Connecting the Drain Hose
1. Unpack the hose adapter and the flat rubber

washer.
2. Push the washer over the threaded end of the

hose adapter up to the shoulder.

3. Locate the drain outlet. The drain outlet is on

the rear of the sonic irrigator and is labeled
DRAIN.
4. Put the threaded end of the hose adapter into
the drain outlet and turn clockwise by hand until
tight.
5. Using a wrench, tighten the hose adapter by turning clockwise no more than a
further 1/4 turn beyond hand tight. Do not over-tighten using the wrench as this
may damage the hose adapter.
6. Unpack the drain hose and the hose clamp.
7. Identify the thinner end of the drain hose: this

end will connect to the drain adapter attached in
step 5. Put this end of the drain hose through
the hose clamp.

8. Push the thinner end of the drain hose onto the hose adapter. Tighten the hose
clamp so that it compresses the drain hose onto the hose adapter barb. Make sure
that the connection is water-tight.
9. The free end of the drain hose should be inserted into a site drain fitted with a drain
trap. The drain hose must not loop or kink and must not rise above the height of the
drain outlet at the rear of the equipment. If required, trim the drain hose to length to
achieve the correct fitting. The drain trap must have 50 mm (2.0 in.) minimum
internal diameter. A clear air gap must be achieved between the drain hose and the
site drain.

3.7 Connecting the Overflow Hose
1. Unpack the overflow hose and the hose clamp

50-70 mm.
2. Put the overflow hose through the hose clamp.
3. Identify the overflow outlet. The overflow outlet is located in the middle on the rear
of the sonic irrigator.
4. Push one end of the overflow hose onto the overflow outlet. Tighten the hose clamp
so that it compresses the hose onto the outlet. Make sure the connection is water-
tight.

5. The free end of the overflow hose should drop inside the site drain. The overflow
hose must not kink or have restricted flow. The overflow hose can be cut if it is too
long to drop inside the site drain without kinking. The site drain must have 100 mm
(4.0 in.) minimum internal diameter. A clear air gap must be achieved between the
overflow hose and the site drain.
3.8 Fitting a Recirculation Filter and the Tank Drain Filter

During a wash cycle, fluids are pumped from the tank through to the basket flush
ports and then through any attached hoses and distal connectors. To prevent debris
in the tank from blocking the ports and hoses, a recirculation filter is fitted in the
tank. This filter should be checked and cleaned daily, and replaced when it is soiled
or has been used for 10 wash cycles, whichever occurs sooner.
Before attempting to operate the sonic irrigator for the first time, make sure a
recirculation filter and the tank drain filter are fitted in the tank.
1. Open the lid fully and remove the basket.
2. Identify the tank recirculation port located in the bottom of the tank.

3. If a recirculation filter is present in the port,

remove it by pulling the tab up. Make sure the
recirculation filter is clean and undamaged. If a
filter is not present, or is heavily soiled or
damaged, unpack a new recirculation filter.
4. Refit the filter removed in the previous step, or

fit a new recirculation filter by pushing the filter
into the tank recirculation port. Make sure that
the filter is pushed down fully into the port.
5. Put the drain filter into the tank drain on the

right side of the tank.
3.9 Switching on Electrical Power

1. Switch on power to using the isolation switch of the external power socket into
which the equipment is plugged.
2. Switch on the power on the rear of the sonic

irrigator. When the switch is in the ON position
and power is supplied to the sonic irrigator, the
switch will be illuminated.

3. After power-up, the sonic irrigator performs a

Power-On Self-Test (POST) to make sure it is
ready for use. The process takes a few seconds
to configure the equipment and check the basic
operation of the control system, memory, and
sensor interfaces.
4. After the POST completes successfully, the

equipment is ready for use.

CHAPTER 4
Using the Touchscreen Display

This chapter describes how to use 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
USING THE TOUCHSCREEN DISPLAY 31

4.1 The Touchscreen Display

The touchscreen display is used to adjust wash cycle parameters and operate the
equipment. The display also provides information on equipment settings and
activity during a wash cycle operation.
4.2 Screen-saver Mode on the Display
1. If the ultrasonic cleaner is inactive for more than

10 minutes, the display enters the screen-saver
mode.
2. To exit the screen-saver mode, touch anywhere
on the display.
4.3 Entering an Operator PIN (if enabled)

If the equipment has been setup to require an operator authorization code before
operation, Final Rinse appears after power-on. Operator PIN codes are listed in
Operator and Supervisor Authorization Codes on page 135.
32 USING THE TOUCHSCREEN DISPLAY

1. When Final Rinse appears, use the number

pad on the display to enter a valid four-digit
operator PIN (personal identification number).
2. After entering a valid operator PIN, the main

menu controls are unlocked.
4.4 Menu Navigation

On the display, the symbols and are used to scroll left and right through the
menu. The large symbol in the center and any text below it indicate the current
selection. Any operator choices are usually shown at the bottom of the display. To
return to the main menu from any sub-menu, touch the return symbol at the top-left
of the display.
A. Touch to return to the main menu from any sub-menu.

B. Touch to scroll left.
C. Current selection.
D. Touch to scroll right.
E. Operator option(s). Touch on the desired option to proceed.

4.5 Main Menu Functions

The main menu provides access to settings for common equipment functions, as
described in the table below. To return to the main menu from any selection or
sub-menu, touch the symbol at the top-left of the display until the main menu is
reached.
Table 4.1 Main Menu Functions
Symbol Name Function

Commence the procedure for loading
Wash cycle instruments, filling the tank, adjusting wash
settings, and starting a wash cycle.
Wash program Select wash program from preset selection.
Prime Chemical Prime chemical pump. Ensures chemical hoses

Pump are purged of air after changing chemical bottle.
Adjust the time and date settings used by the

Clock
equipment for the display and data logging.
Authorized access for supervisors to change the

Supervisor menu language setting, and change the Supervisor
PIN.
Download the wash cycle logs onto an external

Data logging
USB flash drive.
Show the serial number, total wash cycle count,

Information
and current software version for the equipment.

4.6 Information on the Display During a Wash Cycle
Figure 4.1 Example of the display during a wash cycle
A. Pause; touch to pause the wash cycle.

B. Current wash cycle stage.
C. Temperature of fluids (water and chemical mix) in the tank.
D. Water heater; orange when heating, gray when off.
E. Shows either the time elapsed or the time remaining for the current
stage.
F. Current action within the stage of the wash cycle.
G. Progress bar and name of wash program.

Symbols in the center of the display give additional information on the equipment
activity during the wash stages:
Symbol Meaning
Represents the inlets to tank. Blue represents cold water
inlet, red represents hot water inlet, yellow represents
chemical inlet. When an inlet is open, allowing fluids into
tank, a "stream" is shown under the inlet operating.
A representation of whether the tank is full or empty. The fill

level sensor detects only when the tank is full. This is a
general indication only and does not represent actual
physical height of water inside tank.
When shown, indicates that the circulation pump is

operating, pushing cleaning fluids through the basket
manifold and any instruments connected to basket flush
ports. Additionally, Flushing is shown as the current action
on the display (see 'F' above).
When shown, indicates that ultrasonic transducers are

operating. When ultrasonic transducers are operating to
remove gases in washing water, Degassing is shown as
current action on the display. When ultrasonic transducers
are operating to create cavitation on the surface of
submerged instruments, Sonics is shown as current action
on the display (see 'F' above).

CHAPTER 5
Preparing Chemicals
This chapter describes the use of chemicals with the sonic irrigator.
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
PREPARING CHEMICALS 37
5.1 Use of Chemicals

The sonic irrigator has been designed to connect to a chemical bottle. Chemical is
required during the main wash stage of a wash program. The chemical bottle is
placed close to the sonic irrigator and is drawn up through a chemical pickup when
required by wash program settings.

and lines.
CAUTION — Chemical hazard

Since the equipment contains heating devices, use of substances or
chemicals other than those specified in this manual may be hazardous.
l ALWAYS 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.
l ALWAYS check the expiry date on chemical containers before use.
l For correct disposal of chemical containers, refer to the manufacturer
instructions and local regulations.
38 PREPARING CHEMICALS
5.2 Recommended Chemistries — North America Only
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.
Item Number Description

1C2408 Prolystica™ 2X HP enzymatic manual cleaner, 4 x 1.0 US gal
(4 x 3.78 L)
1C2410 Prolystica™ 2X HP enzymatic manual cleaner, 2.5 US gal
(9.46 L)
1C3308 Prolystica™ 2X enzymatic pre-soak and cleaner, 4 x 1.0 US gal
(4 x 3.78 L)
1C3310 Prolystica™ 2X enzymatic pre-soak and cleaner, 2.5 US gal
(9.46 L)
Note: Certain products may not be available in your area. Contact your local
supplier for product availability and ordering information.
5.3 Recommended Chemistries — Outside North America
CAUTION
Item Number Description

1C39T4WR 8E-Zyme™ multi-enzymatic cleaner, 2 x 5.0 L (2 x 1.3 US gal)
1C21T4PE Prolystica™ HP neutral automated detergent, 2 x 5.0 L
(2 x 1.3 US gal)
1C22T4PE Prolystica™ HP enzymatic automated detergent, 2 x 5.0 L
(2 x 1.3 US gal)
1C38T4EC Prolystica™ HP multi-enzymatic cleaner, 2 x 5.0 L (2 x 1.3 US gal)
1C20T4PE Prolystica™ HP alkaline automated detergent, 2 x 5.0 L
(2 x 1.3 US gal)
Note: Certain products may not be available in your area. Contact your local
supplier for product availability and ordering information.
5.4 Connecting the Chemical Pickup
1. Unpack the chemical pickup.
2. Identify the chemical port. The chemical port is

on the rear of the sonic irrigator and is labeled
CHEMICAL PORT 1.
3. Push the connector of the chemical pickup into
the chemical port. When fully inserted, a pin is
pushed in and a securing clip moves to hold the
connector in place. Tug gently on the connector
to make sure it is held in the port and does not
detach.
4. If the connector will not go into the port,

securing clip may need resetting. Push the tab
on chemical port until the pin is released. Then
try inserting the connector as above.
5.5 Using a Chemical Bottle

and lines.
The chemical bottle should be regularly replaced with fresh chemical, and
whenever chemical is insufficient for planned wash cycles. The quantity of chemical
in bottle should be checked regularly before wash operations.
1. If the chemical pickup has been used previously with a chemical bottle, remove the
chemical pickup from the old chemical bottle.
2. Inspect the filter at the end of the chemical pickup. Make sure the filter is clean and
free from debris. If necessary, rinse the filter under running water.
3. Remove the cap from the new chemical bottle.
4. Put the chemical pickup into the new chemical

bottle.
5. Feed the hose down through the chemical

bottle stopper and make sure the pickup
reaches to the bottom of the chemical bottle.
6. The chemical pump must now be primed to prevent chemical cross-contamination.

See Priming the Chemical Pump below.
5.6 Priming the Chemical Pump

Priming the chemical pump prevents cross- contamination when changing a
chemical bottle, and ensures the correct dosage of chemical is delivered into the
tank when demanded.
The chemical pump should be primed in the following situations:
l Before the first wash cycle.
l Every time the chemical bottle is changed.
l If the chemical pickup is removed from the chemical bottle for any reason. The
chemical pickup must be fully inserted into a full chemical bottle before
attempting chemical pump priming.
1. Make sure the chemical pickup is fully inserted

into and reaches to the bottom of the chemical
bottle.
2. Open the lid on the sonic irrigator so that the

chemical delivery port inside the tank can be
seen.
3. On the display, from the main menu, touch

repeatedly on or until the flask symbol
is centered andPrime Chem. Pump and
Detergent appear below the flask symbol.
4. On the display, touch Prime Chem. Pump at the bottom of screen. The button
changes color to indicate that the chemical pump is now active and pumping
chemical from the chemical bottle. The chemical pump will operate and then turn off
automatically.
5. Repeatedly operate the chemical pump until

chemical can be seen entering the tank from
the chemical delivery port. The chemical pump
is now primed.
6. The chemical pump can be turned off at any time by touching once on Prime
Chem. Pump on the display while the chemical pump is operating.
CHAPTER 6
Using the Instrument Basket

This chapter describes the use of the instrument basket.
6.1 The Instrument Basket 46
6.2 Basket Care and Inspection 46
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
USING THE INSTRUMENT BASKET 45

6.1 The Instrument Basket

The instrument basket has 6 flush ports for lumen flushing of cannulated
instruments. The basket can be used to process instruments of the following types:
l General surgical instruments
l Cannulated (lumened) instruments
The instrument basket can be loaded with a

mix of general and cannulated instruments.
It is recommended that general instruments
are loaded first, and then cannulated
instruments.
6.2 Basket Care and Inspection

The basket requires considerate care and regular inspection. A baskets that is
treated harshly is susceptible to damage. Issues with wash cycle errors can often
be traced back to a basket with cracked manifolds or damaged or missing flush
ports.
The basket should always be inspected before any loading of instruments. Defects
and damage to basket manifolds or flush ports can result in poor cleaning
performance and alarm conditions resulting in a wash cycle abort.
46 USING THE INSTRUMENT BASKET

6.2.1 Basket Frame — Care

The basket is designed to fit exactly within the tank. Avoid placing any weight on the
basket that may distort the frame or twist the frame out of shape.
When docking the basket into the tank, the basket should slide into place smoothly
without the need for excessive force. Avoid banging the basket into the tank or
trying to ram it into position with excessive force. If the basket that does not dock
into the tank normally, it should not be used and should be repaired or replaced.
6.2.2 Basket Manifolds — Care

The white plastic manifolds on the basket must always be treated with care. Avoid
impacting the manifolds when loading and unloading instruments and at all other
times. Cracks in manifolds can cause loss of irrigation pressure and errors in wash
cycles.
The basket manifolds connect with ports within the tank. If a connection is
compromised through damage to the manifold inlet, pressure to the flush ports is
lost, and instruments cannot be effectively irrigated.
6.2.3 Basket Flush Ports — Care

Basket flush ports should always be treated with care. Avoid impacting the flush
ports when loading and unloading instruments and at all other times. Only use luer
hoses that are compatible with the basket.
When attaching or detaching a luer hose, do not use excessive force to push or pull
the connector. Do not poke anything into a flush port, or use any tool to detach
hoses.
If a hose cannot be secured with the port retaining clip, the connection is
compromised and cannot be used. If the basket has any damaged flush ports, it
cannot be used and should be replaced.

6.3 Removing the Basket from the Tank

The basket should always be removed from the tank for loading and unloading of
instruments. Never place instruments directly into the tank.

after operation.
The basket should always be removed from tank for loading of instruments.
1. Open the lid fully.
2. Using both hands, pull the basket handles upwards. Handles turn about pivots and
push basket locking assemblies away, releasing the basket.
3. Remove the basket from the tank by lifting up using the basket handles. Keep the
basket level until completely free from the tank.
4. With the basket above the tank, tilt the basket to allow fluids to drain back into the
tank.
5. Move the basket to a draining area away from the sonic irrigator to allow any
residual fluid to drain out.
6. If the basket contain instruments that have been processed in a wash cycle, see
Unloading Instruments from the Basket on page 55.

6.4 Loading General Instruments

General (non- cannulated) instruments with no internal surface, such as clamps,
scissors, and forceps, can be placed directly into the basket.
1. Open mechanical instruments, such as scissors

and clamps.
2. Place instruments in the basket, distributing

evenly. Make sure instruments do not protrude
through the basket or above the top of the
basket.
3. Any small instruments that may fall through the
basket mesh should be first placed inside a
smaller mesh tray, and then placed in the
basket.
4. If no cannulated instruments are being processed, make sure a luer hose attached
to a distal connector is added to each flush manifold to aid water circulation.
Refer to Loading Cannulated Instruments below for procedure on attaching luer
hoses and distal connectors.
6.5 Loading Cannulated Instruments

Cannulated (lumened) instruments should be attached to basket flush ports to
receive flushing during the wash cycle. A standard basket luer hose and a suitable-
sized distal connector will be required to attach each instrument to a basket flush
port.
1. Inspect the basket. Make sure that the baskets flush manifolds are undamaged and
are in a good condition.

2. Inspect the luer hoses and distal connectors.

Make sure luer hoses have no kinks or
ruptures. Make sure distal connectors are
undamaged. Reject any damaged hoses or
connectors.
3. Select a distal connector that best fits over the

end of the instrument. The distal pack, included
with the equipment when shipped, has 4 sizes
of distal connector.
4. The instrument should be able to push through

the silicone opening of the distal connector and
not fall out, but not be held tightly as the area
being clamped will not be cleaned. DO NOT
push an instrument into a distal connector that
is smaller than the instrument end, as this could
damage the distal connector silicone opening.
5. Pick up a luer hose and push the blue luer lock

onto a distal connector and turn clockwise until
firmly attached.

6. Place the instrument with attached distal

connector and luer hose into the basket. Make
sure the instrument does not poke through the
basket or point upwards.
7. Attach the luer hose to a basket flush port. Push

the connector of the luer hose into a port until it
clicks into position. Pull lightly on the hose to
make sure the connection is secure.
8. The instrument is now loaded. Load additional

instruments as required. Make sure instruments
are evenly distributed around the basket. Do
not overload the basket.

6.6 Docking the Basket into the Tank

The basket should be docked in the tank before attempting to start a wash cycle.
Make sure that instruments are completely contained within the basket and are not
in contact with either the walls or floor of the tank.
It is recommended to always inspect and clean the recirculation filter, clean the
level sensors, inspect the tank docking ports, and inspect the drain filter before
every wash cycle.
1. Open the sonic irrigator lid fully.
2. Make sure that the recirculation filter is clean. The recirculation filter should always
be removed, cleaned, and then refitted before docking the basket in the tank.
Replace the recirculation filter if heavily soiled or if it has been used for 10 wash
cycles.
3. Make sure that the drain filter is clean. The drain filter should always be removed,
cleaned, and then refitted before docking the basket in the tank.

4. Clean the 3 water level sensors with a soft

nylon brush or non-greasy alcohol wipes.
5. Inspect the 2 tank ports. The tank ports should

be clear of any debris or deposits, and the red
silicone port seal should be present and in good
condition.
6. Make sure that no instruments protrude through

or above the basket and that no instruments are
pointing upwards.
7. Lift the basket using both handles. Move the
basket slowly and be mindful instruments may
move or fall through the basket. If any
instrument starts to protrude through the
basket, it must be repositioned before
attempting to dock the basket in the tank.

8. The basket will only dock in the tank when orientated with flush ports at the front.
Always orientate the basket so that the flush ports are at the front before attempting
to dock the basket in the tank.
9. Slowly lower the basket into the tank, keeping it

level at all times.
10. Release the basket handles and make sure the side latches engage over the top
edge of the basket on both sides. If necessary, push the basket down until both side
latches are engaged.

6.7 Unloading Instruments from the Basket
IMPORTANT
Before unloading instruments, visually inspect the loaded basket. Make sure
that instruments appear cleaned, and are free from debris and deposits.
Make sure that no instruments appear detached from hoses. If distal
connectors have been used, make sure they have NOT detached from either
the instrument, or the luer hose.
Debris and deposits are a sign that the load has not processed correctly.
Review the wash cycle log for possible causes of a wash error. The entire
load should be reprocessed.
A detached hose, or an instrument that has detached from a distal connector
can result in an instrument that may NOT have been cleaned satisfactorily.
The instrument should be reprocessed.
For any cannulated (lumened) instruments, it is recommended that luer hoses and
connectors are removed one at a time and inspected before accepting an
instrument as processed.
1. Before unloading instruments, visually inspect the load. If any luer hose appears
constricted, cleaning may have been compromised and the instrument
connected to it should be reprocessed.
2. Push the tab on the basket flush port to release

the luer hose, then pull the luer hose to
disconnect it from the basket flush port.
3. Turn the luer lock counter-clockwise to

disconnect the luer hose from the distal
connector.

4. Pull the instrument out of the distal connector.
5. Inspect the luer hose and distal connector for

ruptures or damage. Discard any damaged luer
hose or distal connector. If the luer hose or
distal connector is damaged, the
instrument will require reprocessing.

CHAPTER 7
Performing a Wash Cycle

This chapter describes how to perform a wash cycle, monitor progress of a wash cycle, and
confirm completion of a successful 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
PERFORMING A WASH CYCLE 57

7.1 Cleaning Before Every Wash Cycle

The following cleaning should always be performed before every wash cycle,
unless the tank fluids have been retained using the rewash function. In the case of a
tank full of fluids, only step 1 below can be performed.
1. Open the lid fully. With a clean cloth and

disinfectant cleaner, wipe the lid seal and the lid
magnet.
2. If the tank is empty, remove the recirculation filter. If the filter has been used for 10
wash cycles, replace it with a new filter. Remove any soil, clean with disinfectant
cleaner, then rinse under running water. Fit the recirculation filter into the tank.
3. If the tank is empty, remove the filter from the tank drain. Clean the filter with
disinfectant cleaner, then rinse under running water. Fit the filter in the tank.
58 PERFORMING A WASH CYCLE

4. If the tank is empty, clean the 3 water level

sensors with a soft nylon brush or non-greasy
alcohol wipes.
7.2 Selecting a Wash Program

The wash program that the sonic irrigator will use for the next wash cycle is shown
on the Load Instruments screen. The sonic irrigator defaults to the wash program
last used. To select a different wash program, follow the procedure below.
1. On the display, touch or repeatedly until

the wash program symbol is centered and
Select Program appears above the symbol.
2. At the bottom of the display, touch to cycle up through wash programs, or touch
to cycle down through wash programs. Cycle through wash programs until
desired wash program appears on the display. For details on the wash programs
available, see Wash Program Configuration on page 106.
3. After selecting the desired wash program,

touch or repeatedly until the start cycle
symbol is centered. Confirm that the name of
the desired wash program appears on the
display below the start cycle symbol.

7.3 Starting a Wash Cycle

1. Visually inspect the quantity of chemical in the bottle attached to the chemical port.
Make sure that there is enough chemical for the wash cycle.
2. From the main menu, touch or

repeatedly until the start cycle symbol is
centered and Load Instruments appears at the
bottom of the display.
3. Confirm that the wash program name shown on the display matches the desired
wash program. If the desired wash program is not shown, follow procedure for
Selecting a Wash Program on the previous page.
4. Touch Load Instruments the at bottom of the display.
5. If not already done, load instruments into the basket.Loading General Instruments
on page 49 and Loading Cannulated Instruments on page 49
6. If not already done, dock the loaded basket into the tank. Follow the procedure for
Docking the Basket into the Tank on page 52.
7. Close the lid fully.
8. Touch Start at the bottom-left of the If all

loaded. The wash cycle will start and progress
through each stage as required.

7.4 Wash Cycle Stages

The stages of a wash cycle are controlled by the wash program parameters. Some
wash programs may skip some stages. The wash program parameters can be
checked through the supervisor menu.
Start cycle Confirm loading Confirm basket is docked in tank.
Filling Tank fills from cold water inlet.

Prewash Flushing Pulsed lumen flushing.
Draining Water drains from tank.
Filling Tank fills from hot and cold water inlets.

Dispensing Chemical added on minimum tank level.
Heating Water heats to set point, circulating through lumens.
Washing
Degassing Ultrasonics pulsed to remove dissolved gases.
Ultrasonics/Flushing Alternating ultrasonics and lumen flushing.
Filling Tank fills from hot and cold water inlet.

Rinsing
Flushing Alternating spray and lumen flushing.
Filling Tank fills from hot water inlet.

Final rinse
Flushing Pulsed lumen flushing.
Cycle Confirm Acknowledge cycle completed.

complete Unload Unload basket and confirm unloading.

7.5 On Completion of a Wash Cycle

This procedure describes the operator actions necessary on the completion of a
normal wash cycle, such as set in program 1 "Complete Wash Cycle". This
procedure does not apply for the completion of rewash cycles, and instead actions
described in On Completion of a Rewash Cycle on page 69.
1. At the end of a wash cycle, a chime is emitted

and Cycle Complete appears on the display.
2. Touch Unload on the display to confirm that the

cycle completed with no errors.Cycle
Complete - Unload now appears on the
display.
3. Open the lid slowly and partially to allow hot
vapors to escape from the tank. When vapors
have escaped, the lid can be opened fully.

after operation.
4. Remove the basket from the tank. See Removing the Basket from the Tank on
page 48.

5. Remove instruments from the basket. See Unloading Instruments from the Basket
on page 55.
WARNING
If a luer hose or connector, or luer hose appears restricted due to instrument
movement, the instrument should be reprocessed.
6. Touch OK on the display to confirm the

unloading of instruments. The display returns to
the Load Instruments screen.
7. The sonic irrigator is now ready for the loading
of instruments to be processed in a new wash
cycle.
7.6 Pausing or Aborting a Wash Cycle

During operation it is possible to pause or abort the wash cycle if required.
1. During the wash cycle, touch the symbol

located at the top-left of the display. The wash
cycle is immediately paused and Cycle Paused
appears on the display. The wash cycle will also
pause if the lid is removed during the wash
cycle.
2. To resume the wash cycle, touch Resume at
the bottom left of the display.
3. To abort the wash cycle, touch Abort on the

bottom right of the display. PROGRAM
ABORTED appears as confirmation that the
wash cycle has aborted.

4. Touch OK on the display to confirm recognition that the wash cycle was aborted.
The tank will be drained of fluids and the display will return to the Load Instruments
screen when the tank draining is completed.
5. Instruments must be processed in a new wash cycle.
7.7 Wash Cycle Errors

If an unexpected condition occurs, the equipment will abort the wash cycle, emit an
audible alarm, and an error message will be shown on the display with the reason
for the abort. The cycle log will record the error code, description of error, and
diagnostic information.
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.
1. When an error occurs, an audible alarm is

emitted, and an error code appears on the
display.
2. The reason for the abort should be investigated
using the reported error code to diagnose the
cause. Follow the advice given. See
Diagnosing Error Codes on page 96.
3. After noting the error code reported, touch OK on the display to confirm that the
error has been recognized.

4. If the tank was not empty when the abort occurred, the tank will empty
automatically. The sonic irrigator will then reset and the display returns to the main
menu.
5. Instruments must be reprocessed if the error occurred during the wash

cycle.

CHAPTER 8
The Rewash Feature

This chapter describes the rewash feature, which can be set for any unlocked wash programs,
and may be available on some shipped equipment configurations.
8.1 Rewash Program Setting 68
8.2 The Rewash Counter 68
8.3 On Completion of a Rewash Cycle 69
THE REWASH FEATURE 67

8.1 Rewash Program Setting

Within a wash program, if the rewash parameter is set above zero, the rewash
feature is enabled. When the rewash feature is enabled, the tank fluids do not drain
at the end of the first wash cycle. The operator then has the option to reuse the tank
fluids for the next wash cycle.
If the sonic irrigator has editable (open) wash programs, the rewash parameter can
be set and adjusted through the supervisor menu. Some configurations of sonic
irrigator may ship with one or more factory-set rewash programs. The equipment
owner can use the supervisor menu to view program settings and see what rewash
options are available.
The rewash feature is intended for heavily soiled instruments only. On completion
of a rewash cycle, it is strongly recommended that instruments are further
processed in a standard wash cycle to rinse off any remaining soil and chemicals.
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 prewash 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.
8.2 The Rewash Counter
When using the rewash option, a number is

shown after the washing stage name to indicate
how many times the same tank fluids have been
used.
When the number of times the tank fluids have
been used reaches the number set in the
rewash program parameters, the tank drains at
the end of that cycle, and the operator is not
given the option to reuse the tank fluids.
68 THE REWASH FEATURE

8.3 On Completion of a Rewash Cycle

At the end of a rewash cycle, if the number of washes with tank fluids is less than
the number set in the rewash counter, the tank fluids can be retained in the tank for
the next wash cycle. At the end of the rewash cycle, the operator is asked if they
want to perform another wash cycle using the same tank fluids.
If, at the end of a rewash cycle, the number of washes with tank fluids has reached
the number set in the rewash counter, the operator is not given the option to retain
tank fluids and the tank automatically drains at the end of the cycle.
At the end of each day, the tank should be emptied.
1. At end of a rewash cycle, the Wash End screen

appears on the display.
2. To reuse tank fluids and perform another
rewash cycle, touch Yes on the display. If tank
fluids are not to be reused, touch No. The tank
will automatically empty.
Note: At the end of each day, the tank should be emptied so that daily cleaning and
inspection can be performed at the start of the next day's use. On the last
rewash cycle of the day, touch No so that the tank will automatically empty.
3. Open the lid slowly and partially to allow hot vapors to escape from the tank. When
hot vapors have escaped, the lid can be opened fully.

after operation.
4. Wearing gloves suitably rated for thermal protection, remove the basket from the
full tank of fluids and move to an unloading area away from the sonic irrigator.
5. Remove instruments from the basket. See Unloading Instruments from the Basket
on page 55.
THE REWASH FEATURE 69

6. Load the basket with instruments to be processed in the next rewash cycle. Follow
procedure for Loading General Instruments on page 49 and Loading Cannulated
Instruments on page 49.
7. Slowly put the loaded basket into the tank full of fluids. Be careful of hot water
splashes.
8. Touch Reload Complete on the display to

confirm the loading of instruments.
9. The next rewash cycle starts immediately.
70 THE REWASH FEATURE

CHAPTER 9
Maintenance
This chapter describes maintenance of the equipment, including periodic cleaning
and inspection.

manufacturer.
MAINTENANCE 71
9.1 Important Safety Information

manufacturer.
WARNING
Before performing any maintenance, make sure that the mains power is
disconnected.
CAUTION
All maintenance procedures should be carried out in a well-lit environment,
recommended minimum lighting level is 500 lux (46.5 foot-candle).
CAUTION
Follow recommended safety precautions for cleaning products in use.
CAUTION
It is recommended that Personal Protection Equipment (PPE) is worn during
loading/unloading, and cleaning or decontaminating of equipment. This must
include apron, gloves, and eye-protection.
CAUTION
Use non-abrasive cleaners for cleaning internal and external surfaces of the
equipment. Follow directions on container and rub in a back-and-forth motion
in same direction as surface grain. Abrasive cleaners damage stainless steel.
Cleaner rubbed in circular motion, or applied with wire brush or steel wool will
scratch and dull stainless steel.
72 MAINTENANCE
CAUTION
In the interests of health and safety, all medical washers should be cleaned as
part of a routine maintenance program. This will ensure that the equipment is
safe for operators and maintenance personnel. To keep your equipment
operating within the design parameters, the following checks must be
performed on a regular basis. Please note that the completion of these
checks is not a substitute for regular servicing and maintenance by a suitably
qualified technician.
9.2 Daily Cleaning and Inspection

The cleaning and inspection described below is a general guide for use. The
equipment owner should review and set a cleaning and inspection procedure that is
appropriate for their frequency and manner of use.
1. If the tank is full, due to the use of the rewash function, the tank should first be
emptied by aborting the wash cycle, or choosing to end the rewash. See On
Completion of a Rewash Cycle on page 69 and Pausing or Aborting a Wash Cycle
on page 63.
2. Make sure there is sufficient chemical in the chemical bottle for the day's planned
wash cycles.
3. Open the lid fully. With a clean cloth and

disinfectant cleaner, wipe all surfaces of the lid.
Pay particular attention to the lid seal. Make
sure the lid seal and the lid magnet are in good
condition.
MAINTENANCE 73
4. Remove the basket from the tank and inspect it. Make sure the basket flush ports
are undamaged and free of blockages or debris. Inspect under the basket and
make sure the basket manifolds are undamaged and free of blockages or debris.
Note: Basket manifolds are designed to fit loosely in the corners of the basket. This
is not a defect. The movement allows the manifolds to locate correctly onto
the tank docking ports when the basket is put into the tank.
5. Remove the recirculation filter from the tank. Inspect the condition of the filter. If the
filter has been used for 10 wash cycles or is heavily soiled, replace it with a new
filter. Otherwise remove any soil and clean the filter with a disinfectant cleaner and
then rinse under running water. Refit the filter in the tank.
74 MAINTENANCE
6. Remove the drain filter from the drain. Inspect the condition of the filter. Remove
any soil and clean the filter with a disinfectant cleaner and then rinse under running
water. Refit the filter in the tank drain.
7. Clean the 3 water level sensors with a soft

nylon brush or non-greasy alcohol wipes.
8. Inspect the 2 tank ports. The tank ports should

be clear of any debris or deposits, and the red
silicone port seal should be present and in good
condition.
9. With a clean cloth and disinfectant cleaner, wipe all internal surfaces of the tank.
10. With a clean cloth and disinfectant cleaner, wipe all external surfaces.
11. With a clean wet cloth, remove any trace of disinfectant cleaner from internal and
external surfaces of the sonic irrigator and the lid.
12. Cleaning performance should be tested each day the sonic irrigator is used, and all
test results recorded.
MAINTENANCE 75
9.3 Weekly Cleaning and Inspection

1. If the tank is full of fluids due to continuing rewash cycles, the tank should be
emptied by canceling the rewash.
2. Perform all daily cleaning and inspection. See Daily Cleaning and Inspection on
page 73.
3. Make sure the mains power cable is not trapped, or damaged.
4. Inspect the drainage connections and supply hose for leaks, kinks, or damage.
5. Perform a full decontamination, See Performing a Full Decontamination on the
facing page.
9.4 Checking the Time and Date Settings

The time and date should be set correctly to ensure the accuracy of wash cycle
records, and should be periodically checked by the operator. There is no automatic
provision for adjusting to daylight saving hours. When the equipment is powered
off, an internal battery maintains the time and date.
To view the current time and date setting, from

the main menu, touch repeatedly on or
until the clock symbol is centered. The
current time and date settings appear below the
clock symbol. The touchscreen buttons below
the current time and date are used to adjust
settings.
9.4.1 Time Setting Adjustment
1. On the display, within the main menu, touch

or repeatedly until the clock symbol is
centered and the time and date appear below it.
2. Touch Set Time at the bottom of the display.
3. On the Set Time screen, touch and to

adjust hours, minutes, seconds settings as
required.
4. Touch to return to the main menu.
76 MAINTENANCE
9.4.2 Date Setting Adjustment
1. On the display, within the main menu, touch

or repeatedly until the clock symbol is
centered and the time and date appear below it.
2. Touch Set Date at the bottom of the display.
3. On the Set Date screen, touch and to

adjust day, month, year settings as required.
4. Touch to return to the main menu.
9.5 Performing a Full Decontamination

1. Perform a daily cleaning procedure according to Daily Cleaning and Inspection on
page 73.
2. Remove the chemical pickup from the chemical bottle and disconnect from the
chemical port at the rear of the sonic irrigator.
3. Put a disinfectant solution of 5% non-foaming Sodium Hypochlorite into a shallow

heat-resistant container (this prevents it from being drained at start of cycle).
Disinfection solution Volume required for tank

5% of non-foaming 5% is equivalent to
Sodium Hypochlorite 1000 ml (33.8 US fl.oz)
MAINTENANCE 77
4. Put the container of disinfectant solution in the

basket.
5. Connect a luer hose with an attached distal connector to a flush port on each basket
manifold. This aids fluid circulation to ensure both manifolds are disinfected.
6. Put the basket into the tank and make sure it is

fully docked.
7. On the display, select the Decontamination wash program. Alternatively, a user-

definable decontamination program can be defined using the supervisor menu if
required.
8. Start the wash cycle.
9. Confirm that the wash cycle completed with no

errors.
78 MAINTENANCE
10. If preparing equipment for shipping, fill out a Decontamination Certificate. See
Decontamination Certificate on page 133.
If the Decontamination Certificate is not visible, the courier and/or the
supplier can refuse to accept item(s).
9.6 Accessories and Replacement Parts

A range of manufacturer- approved accessories and replacement parts may be
purchased from your supplier. The use of compatible approved products will ensure
continued and reliable operation of your equipment.
CAUTION
Table 9.1 Accessories and Replacement Parts
Item number Description

IW1042 Standard basket and hose set
IW1044 Instrument organizer
IW1019 Hose and luer assembly (pack of 12)
IW1026 Distal connectors red, 1 mm (pack of 10)
IW1027 Distal connectors blue, 5 mm (pack of 10)
IW1028 Distal connectors yellow, 8 mm (pack of 10)
IW1029 Distal connectors green, 12 mm (pack of 10)
MED4817 Chemical pickup
HOSE002 Water inlet hose with blue indicator
HOSE007 Water inlet hose, stainless steel
HOSE010 Overflow hose, 50 mm ID x 1 m
MED3020 Drain hose
MED3024 1/2 in. x 20 mm hose adapter
MET098 Drain filter
IW1041 Disposable recirculation filter (pack of 24)
MAINTENANCE 79
Table 9.1 Accessories and Replacement Parts (continued)
Item number Description

IW1022 Disposable recirculation filter (pack of 100)
FUSE009 Cartridge fuse, 8 A, 500 V
FUSE015 Cartridge fuse, 12.5 A, 500 V
9.7 Equipment Servicing

It is recommended that this equipment is serviced every 6 months. Servicing should
only be performed by a supplier-approved service technician.
When the equipment is serviced, the service technician will update the service
record included in this manual. See Service Record on page 130 . The
recommended date for next service should be noted, and the service scheduled by
this date.

manufacturer.
80 MAINTENANCE
CHAPTER 10
The Supervisor Menu

This chapter describes 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
THE SUPERVISOR MENU 81

10.1 Functions Available Through the Supervisor Menu

The supervisor menu unlocks access to following:
• Change the PIN used to unlock the supervisor menu.
• View factory-set wash programs settings.
• Edit user-definable wash programs settings (if enabled).
• Select either the 12-hour or 24-hour clock setting for time on the display.
• Select either metric or US units the for temperature and fluid quantity.
• Change the language used by the display and cycle records.
10.2 Unlocking the Supervisor Menu
1. On the display, from the main menu, touch

or repeatedly until the supervisor symbol
is centered and Supervisor Menu appears at
the bottom of the screen.
2. Touch once on Supervisor Menu at the bottom
of the screen.
3. Use the number pad on the display to enter a
valid 6-digit supervisor PIN.
Note: The default supervisor PIN setting is
listed in Operator and Supervisor
Authorization Codes on page 135.
82 THE SUPERVISOR MENU

10.3 Changing the Supervisor PIN
IMPORTANT
If the supervisor PIN is changed and then forgotten, it can ONLY be reset by a
service manufacturer-approved service technician. A service visit to reset the
supervisor PIN is NOT covered by warranty, and will be chargeable to the
customer.
1. Unlock the Supervisor Menu using the supervisor PIN. See Unlocking the
Supervisor Menu on the previous page.
2. Within the Supervisor Menu, touch or

repeatedly until the padlock symbol and Final
Rinse appears.
3. Touch once on Final Rinse at the bottom of the
display.
4. Use the number pad on the display to enter a

new 6-digit supervisor PIN. The display then
asks for confirmation of the number entered.
5. Use the number pad on display to confirm the

new 6-digit supervisor PIN.
6. If the new supervisor PIN entered the first and

second time do not match, the supervisor PIN
will not be changed and you must try again.

7. If the new supervisor PIN entered the first and

second time match, the supervisor PIN is
changed and the display will return to Final
Rinse.
10.4 Viewing and Editing Wash Program Parameters

Within the supervisor menu, wash program parameters can be viewed. If a wash
program is unlocked, the program parameters can also be adjusted using the
display. Locked wash programs can only be viewed and not adjusted.
If a wash program is unlocked, the text at the bottom of the display will read Edit
Program #. If a wash program is locked, a padlock symbol is shown and the text
at the bottom of the display will read View Program # .
1. Unlock the supervisor menu using the supervisor PIN. See Unlocking the
Supervisor Menu on page 82.
2. On the display, touch or repeatedly until the desired wash program name
appears under the wash program symbol . If a padlock symbol appears in the
bottom left corner of the screen, the wash program is locked and can only be
viewed. If there is no padlock symbol, the wash program is unlocked and can be
edited.
3. Touch View Program # to view a locked wash program, or touch Edit Program # to
view or edit an unlocked wash program parameters.

4. When viewing wash program parameters, touch to move to the next screen, or
touch to go back to the previous screen. If the wash parameters are editable, the
adjustment symbols and appear under each parameter and can be used to
adjust the setting.
Note: A value of 0 °C (+32 °F) is interpreted as 'temperature not important' by the
equipment. The tank will fill with water from the supply hoses, the equipment
will not attempt to regulate the incoming water temperature, or adjust the
temperature of the water in the tank.
Note: Values of 0m (zero minutes) or 0x (zero repetitions) are interpreted as 'do
not perform stage'.
IMPORTANT
Sonic activity during the degassing and washing stages of a wash program
can increase the temperature of the tank water at a rate up to 0.5 °C/min.
(0.9 °F/min.).
Setting a hot wash cycle with a long period of degassing and a long duration
wash stage can cause the tank water to exceed the maximum permitted
temperature, resulting in the system aborting the cycle and reporting
error code 23 (water temperature too high).
If this occurs, the wash cycle parameters should be changed to reduce the
degassing and/or washing periods, and/or increase the set wash
temperature.
Program Name
This screen only appears for unlocked wash
programs, and allows the wash program name
to be edited using the on-screen keyboard. The
program name is limited to the display width
and a maximum of 30 characters.
Pre-wash
On the left is the duration of the pre-wash
stage in minutes (0 to 20). On the right is the
number of times the pre-wash stage is
performed (0 to 3). If either value is zero, pre-
wash is not performed.

Degassing
In the center is the duration of the degassing
stage in minutes (0 to 10). If the value is set to
zero, degassing is not performed.
Washing
On the left is the quantity of chemical 1
dispensed (0 to 2000 ml, or 0 to 67.6 fl.oz). In
the center is the water temperature (0 °C to
+60 °C, or +32 °F to +140 °F). On the right is
the duration in minutes (0 to 40).
Rewash
In the center is the number of times the tank
fluids will be used for washing (0 to 10). If value
is set to zero, rewash is not performed and tank
fluids are drained after every washing stage.
Rinsing
On the left is the water temperature
(0 °C to +60 °C, or +32 °F to +140 °F). In the
center is the duration in minutes (0 to 20). On
the right is the number of times the rinsing
stage is performed (0 to 3). If either duration or
number of times is set to zero, rinsing is not
performed.
Final Rinse
On the left is the water temperature
(0 °C to +60 °C, or +32 °F to +140 °F). On the
right is the duration in minutes (0 to 20). If
duration is set to zero, this stage is not
performed.

5. Save Changes
If an unlocked wash program has been edited,
the operator is prompted to save the changes,
or cancel the edit. If no changes have been
made, only the cancel option is enabled, and is
used to return to the supervisor menu main
selections. Touch OK to save changes made to
an unlocked program, or touch Cancel to
discard any changes made to a program or exit viewing a locked program.
10.5 Selecting 12-Hour or 24-Hour Clock Setting

2. On the display, touch or repeatedly until the symbol is centered.
3. Touch on Measurements at the bottom of the display to toggle between 12-hour

and 24-hour clock setting.
4. Touch on the return symbol to exit the supervisor menu and return to equipment
main menu functions.
10.6 Selecting Metric or US Units for the Display and Cycle Logs
Metric or US imperial units can be selected for temperature, fluid volume, and water
pressure. The measurement selection is used by both the display and the recorded
cycle logs.
2. For temperature, touch or repeatedly until the symbol is centered.

3. Touch on Measurements at the bottom of the display to toggle between C (Celsius)

and F (Fahrenheit) for temperature.
4. For fluid volume, touch or repeatedly until the symbol is centered.
5. Touch on Measurements at the bottom of the display to toggle between ml

(milliliters) and floz (US fluid ounces) for fluid volume.
6. Touch on the return symbol to exit the supervisor menu and return to equipment
main menu functions.
10.7 Changing the Language Used by the Display


the symbol is centered and Language
appears.
3. Touch once on Language at the bottom of the
display.

4. The current language setting appears in the

center of the display. Touch or
repeatedly until the desired language appears
in the center of the display.
Available languages appear in the following sequence:

English, Danish, French, German, Japanese, Spanish, Swedish, Finnish, Italian,
Polish, Russian, Portuguese, Norwegian, Lithuanian, Latvian
5. Touch OK to confirm the language selection.

The language used by the equipment is
changed and the display returns to the
Language screen.

CHAPTER 11
Wash Cycle Logs

During wash operations, parameters are reported at key stages as an ASCII serial data
stream. This cycle log is stored in internal memory and can either be downloaded onto a USB
flash drive, or sent to a thermal printer or data logging PC connected via the external RS232
port.
WASH CYCLE LOGS 91

11.1 Connecting a Device to the RS232 Port

The following devices can be connected to the external RS232 port:
• Thermal printer
• Data logging PC
Note: Only IEC/EN 60950-1 certified equipment should be connected.
11.1.1 Connecting a Thermal Printer to the RS232 Port

1. Connect an RS232 data cable to the port marked PRINTER on the rear of the sonic
irrigator.
2. Connect the RS232 data cable to the thermal printer.
3. Connect the thermal printer to a suitable mains power outlet.
4. Load paper into the thermal printer according to the accompanying instructions.
5. Run a test wash cycle to make sure that the wash cycle log is printed correctly.
11.1.2 Connecting a Data Logging PC to the RS232 Port

1. Connect an RS232 null modem to the port marked DATA on the rear of the sonic
irrigator.
2. Connect the RS232 data cable to the data logging PC.
3. Run a serial data logging program, making sure that it is configured as follows:
• Baud rate = 19200 bps
• Data bits = 8
• Parity = none
• Stop bits = 1
• Flow control = none
• Handshaking = off
• Buffer size > 500
• Append line feed to cartridge return
4. Run a test wash cycle to make sure that the wash cycle log is transferred correctly.
92 WASH CYCLE LOGS

11.2 Paper Run Out on Printer

When a red stripe appears on the edge of the paper printout, this is an indication
that the paper roll is about to run out and should be replaced promptly.
If the printer runs out of paper, it can store 10 wash cycles in memory as long as
printer power is maintained. After the paper is replenished, the stored wash cycle
will be printed.
11.3 Downloading Wash Cycle Logs to a USB Flash Drive

1. Make sure the USB flash drive is formatted to FAT32.
Note: The following brands are recommended for use with this equipment:
• Toshiba TransMemory
• Kingston Data Traveler
• SanDisk Cruzer Switch
2. Insert the USB flash drive into the port marked

DATA located located on the rear of the sonic
irrigator.

the symbol is centered and Download Logs
to USB appears below it.
4. All Logs downloads all wash cycles since the
sonic irrigator was first used. New Logs
downloads wash cycles since the last USB
download. Select either All Logs or New Logs.
5. Wait for logs to be copied to the USB flash

drive. The display will report the number of files
being copied and show a progress bar.
WASH CYCLE LOGS 93

6. When the download to the USB flash drive is

complete, the display will show that the copy is
complete and that it is safe to remove the USB
flash drive from the equipment.
7. Touch OK on the display to return to the main
menu.
8. Remove the USB flash drive from the data port.
9. On the USB flash drive, the wash cycle logs are saved in the following location:
STERIS\<machine serial number>\<cycle range>\<cycle number>.txt
94 WASH CYCLE LOGS

CHAPTER 12
Troubleshooting
This chapter describes error messages that may be shown, and performance
issues that may occur during operation of the equipment. When an error message
or performance issue occurs, the following tables indicate common causes of
errors, and corrective actions.
If an error cannot be diagnosed and corrected, or a problem occurs which is not
described in this manual, please contact supplier.

manufacturer.
TROUBLESHOOTING 95
12.1 Diagnosing Error Codes

Use the table below to diagnose and remedy error codes reported on the display.
Table 12.1 Error Codes and Remedy Actions
Error
Error Message Description
Code
1 Mains Power Mains supply to equipment was interrupted during a cycle.

Removed Turn equipment back on and repeat cycle.
If problem persists have electrician or qualified technician
inspect electrical connection.
2 Chamber Overflow Make sure drain is not blocked. See step 3 of Cleaning
Before Every Wash Cycle on page 58.
Make sure instruments are not blocking drain.
Make sure non-foaming chemical is being used. See
Preparing Chemicals on page 37.
If problem persists, contact supplier to arrange a qualified
technician inspection.
3 Drain Timeout Make sure filter is not clogged. See step 3 of Cleaning
Before Every Wash Cycle on page 58.
Make sure instruments are not blocking drain.
Make sure drain hose is not kinked or restricted, and that
site drain is not blocked.
Make sure non-foaming chemical is being used. See
Preparing Chemicals on page 37.
4 Chamber Repeat cycle.

Temperature Sensor If problem persists, contact supplier to arrange a qualified
Mismatch technician inspection.
5 Chamber Fill Make sure that the water inlet hoses are connected and not
Timeout kinked or blocked.
Make sure that the site water supply is on.
Check equipment and water connections for leaks.
If equipment is leaking, contact supplier to arrange a
qualified technician inspection.
96 TROUBLESHOOTING
Table 12.1 Error Codes and Remedy Actions (continued)
Error
Code
6 Chamber Opened Make sure that the lid is closed and remains closed until the
wash cycle is completed.
7 Temperature Set Repeat cycle. If problem persists, contact supplier to

Point not Maintained arrange a qualified technician inspection.
10 Chamber Water Make sure that non-foaming chemical is being used. See
Level Low Preparing Chemicals on page 37.
Check equipment and water connections for leaks. If
equipment is leaking, contact supplier to arrange a qualified
11 Chamber Water Repeat cycle. If problem persists, contact supplier to arrange

Heat Rate Low a qualified technician inspection.
12 Low Water Make sure hot water temperature is 10 °C (18 °F) above wash
Temperature cycle set-point temperature.
14 Chamber Start Tank has not cooled sufficiently since last wash. Make sure
Temperature too cold water supply is below +35 °C (+95 °F).
High Make sure that the cold water inlet hose is connected and
not kinked or blocked.
Make sure that the site cold water supply is on.
Allow more time between washes for the equipment to cool
down.
technician inspection
15 Chamber Switch the equipment off then on again. If problem persists,

Temperature Out of contact supplier to arrange a qualified technician inspection.
Range
20 User Aborted Cycle Determine reason why user aborted cycle.

Repeat cycle.
TROUBLESHOOTING 97
Error
Code
23 Water Temperature Make sure that the hot water temperature is no more than
too High +80 °C (+176 °F). Reduce hot water flow rate at source if
too hot.
Make sure that the cold water flow rate is sufficient.
Make sure that the wash program does not have
excessively long degassing or washing stages that could
lead to heating of the water above set temperature limit.
See note on Viewing and Editing Wash Program
Parameters on page 84.
Repeat cycle.
39 Sonic Generator Switch the equipment off, then on again. If problem persists,
Over Current contact supplier to arrange a qualified technician inspection.
40 Sonic Generator Switch the equipment off, then on again. If problem persists,
Over Temperature contact supplier to arrange a qualified technician inspection.
41 Sonic Generator Low Switch the equipment off, then on again. If problem persists,
Power contact supplier to arrange a qualified technician inspection.
42 Maximum Cycle Make sure that the hot and cold water flow rates are
Time Expired sufficient.
Make sure that the filter is not clogged. See step 3 of
Cleaning Before Every Wash Cycle on page 58.
Make sure that instruments are not blocking the drain.
Repeat cycle.
44 Sonic Cleaning Switch the equipment off, then on again. If problem persists,
Water Level Low contact supplier to arrange a qualified technician inspection.
98 TROUBLESHOOTING
Error
Code
49 Microcontroller Switch the equipment off, then on again. If problem persists,

Watchdog Reset contact supplier to arrange a qualified technician inspection.
52 Real Time Clock Switch the equipment off, then on again.

Read Error If problem persists, contact supplier to arrange a qualified
53 Power Supply Switch the equipment off, then on again.

Voltage Out of If problem persists, contact supplier to arrange a qualified
Range technician inspection.
54 Overfill Occurred Make sure that the filter is clean and not clogged. See step
During Cool Down 3 of Cleaning Before Every Wash Cycle on page 58.
Process Make sure that the drain hose is not kinked or constricted,
and that site drain is not blocked.
Repeat cycle.
55 Sudden Fill - Wipe Clean level sensors.

Fill Level Sensor
57 Microcontroller Stack Repeat cycle. If problem persists, contact supplier to

Overflow arrange a qualified technician inspection.
58 EEPROM Read Repeat cycle. If problem persists, contact supplier to

Error arrange a qualified technician inspection.
59 Unable to store Cycle Repeat cycle. If problem persists, contact supplier to

Log arrange a qualified technician inspection.
TROUBLESHOOTING 99
12.2 Troubleshooting Equipment Behavior

This section describes equipment issues that may occur without showing an error
code on the display.
12.2.1 General Equipment Issues

Issues below relate to general equipment usage. For issues related to wash cycle
operations and wash performance see Troubleshooting Equipment Behavior
above.
12.2.1.1 Sonic irrigator does not power-up.

l Make sure that the main disconnect switch is in the ON position and that
electrical power is supplied to the equipment.
l Facility power may be incorrect for the equipment. If facility power is incorrect
for the equipment, the internal circuit breaker may have tripped. Contact
supplier.
l Make sure that the fuse in the power lead, and the fuses accessible from the
rear of the equipment have not blown.
12.2.1.2 Wipe Fill Sensor appears on the display.
l Debris on the water level sensors can

cause a fill timeout. The 3 water level
sensors should be cleaned. If the fault
persists after thorough cleaning, contact
supplier. See step 4 of Cleaning Before
Every Wash Cycle on page 58.
12.2.1.3 Close Lid appears on the display.
l Make sure that the lid is completely closed.

l Make sure that instruments in the basket
are not preventing the lid from closing.
100 TROUBLESHOOTING
12.2.1.4 Basket does not release from the tank.

l Make sure that BOTH catches inside the tank have moved outwards to release
the basket. See Removing the Basket from the Tank on page 48.
l Make sure that instruments within the basket have not moved, and are not
protruding through the basket preventing unloading. Reposition any
instruments that have moved.
l Make sure that luer hoses and connections have not detached, and are not
protruding through the basket preventing unloading. Reposition any hoses that
appear to have moved.
12.2.1.5 Basket does not dock into the tank.

l Make sure that instruments within the baskets have not moved, and are not
protruding through the basket(s) preventing docking. Reposition any
instruments that have moved.
l Make sure that luer hoses and connections have not detached, and are not
protruding through the basket(s) preventing docking. Reposition any hoses that
appear to have moved.
l Make sure that the basket frame has not been distorted out of shape so that it
does not fit smoothly into the tank. If the basket is distorted or damaged it
should be replaced.
12.2.1.6 Water leaking from the lid area.

l Make sure that all instruments in the basket are lying flat, and no instruments
are pointing towards the lid.
l Inspect the lid seal for damage. If damaged, the seal will need to be replaced by
a service technician. Contact the supplier.
12.2.1.7 Excessive fill time.

l Make sure that the site water connections are sufficient and have pressure
above 2.0 bar (29 psi).
l Make sure that site water valves are open.
l Make sure that the water inlet hoses are not kinked or constricted.
l Make sure that the water inlets are not blocked.
TROUBLESHOOTING 101
12.2.1.8 Excessive drain time.

l Make that tank filter is not blocked. See step 3 of Cleaning Before Every Wash
Cycle on page 58.
l Make sure that drain hose is not kinked or restricted.
l Make sure that site drain is not blocked.
12.2.2 Wash Cycle Issues

Issues below relate to wash cycle behavior and performance. For issues related to
general equipment operations, see Troubleshooting Equipment Behavior on
page 100.
12.2.2.1 Check Chemical appears on the display.
l Make sure that there is sufficient chemical

required by the wash program and replace
the bottle if there is insufficient chemical.
l Make sure that the chemical pickup is fully-
inserted into the chemical bottle.
l Make sure that the chemical pickup is not
kinked or restricted.
l Touch OK on the display after making sure that the chemical bottle and
chemical pickup are in a satisfactory condition. The wash program resumes.
102 TROUBLESHOOTING
12.2.2.2 Instruments not clean after wash cycle.

l Make sure that only recommended chemicals are used. See Preparing
Chemicals on page 37. Make sure that chemicals are used according to
manufacturer instruction.
l Make sure that the tank filter is not clogged. See step 3 of Cleaning Before
Every Wash Cycle on page 58.
l Make sure that the basket is fully docked into the tank. See Docking the Basket
into the Tank on page 52.
l Instruments may be excessively soiled or have been left soiled for more than 2
hours.
l The baskets may be overloaded. Do not load more than the recommended
number of instruments for cleaning. See Using the Instrument Basket on
page 45.
l Make sure that at least one instrument is connected to each flush manifold on
the baskets. See Using the Instrument Basket on page 45.
l Make sure that luer hoses are firmly attached to the flush ports and instruments.
See Using the Instrument Basket on page 45.
l Make sure that luer hoses are not split, ruptured, or kinked. See Using the
Instrument Basket on page 45.
l Make sure that basket manifolds are not cracked or damaged, and that ALL
flush ports are undamaged. See Basket Care and Inspection on page 46.
l Facility power may be incorrect for the equipment. Make sure that the facility
power meets the specified requirements.
TROUBLESHOOTING 103
12.2.2.3 Sonic and/or cleaning efficacy indicator(s) do not confirm expected

equipment performance.
l Make sure that indicator(s) are placed on base of the basket in accordance with
the indicator IFU.
l If the indicator IFU states that the tank must be empty, NO medical instruments
or other items should be loaded.
l The equipment basket should always be used, and the indicator(s) placed
inside the basket.
l Make sure to use only a chemical that is recommended by STERIS and the
indicator IFU.
l Make sure that the chemical dose is as stated in the wash program parameters,
and the indicator IFU.
l Make sure that performance is checked using fresh water in the tank.
l Make sure that equipment performs a factory standard program as described in
the wash program parameters, and the indicator IFU.
l If sonic and/or cleaning efficacy indicator(s) do not confirm expected equipment
performance after following the troubleshooting steps described above, the
equipment owner should contact STERIS or the local distributor. STERIS
contact details are provided at the front of this manual.
104 TROUBLESHOOTING
CHAPTER 13
Wash Programs
This chapter details the wash programs that may be setup on a sonic when shipped.
13.1 Wash Program Configuration 106
13.2 Complete Wash Cycle Program 107
13.3 Wash Only Program 108
13.4 Open Programs 109
13.5 Decontamination Program 110
WASH PROGRAMS 105

13.1 Wash Program Configuration

A total of 6 wash programs are stored in the sonic irrigator internal memory. The
wash programs are loaded into the equipment memory before shipping. The table
below describes the wash program set that is currently shipped.
Table 13.1 Wash Program Configuration
Program slot Unlocked (editable) Name

P1 No Complete Wash Cycle
P2 No Wash Only
P3 Yes Open
P4 Yes Open
P5 Yes Open
P6 No Decontamination
The wash program names can be viewed on

the display by navigating to the Select Program
screen and touching the or buttons to
scroll through the preset programs.
The parameters used by each wash program can be viewed in the supervisor
menu. The parameters of any unlocked wash programs can be edited and saved in
the supervisor menu. See Viewing and Editing Wash Program Parameters on
page 84.
It is recommended that wash program parameters are viewed on the display before
commencing a wash cycle using a particular program. The wash program
parameters listed in this operator manual should only be used as an indication and
may not match with the setup of an individual sonic irrigator as shipped.
106 WASH PROGRAMS

13.2 Complete Wash Cycle Program

The Complete Wash Cycle program is validated to clean, with certainty, up to
5.0 kg (11.0 lb) of instruments.
Instruments go through a pre-wash to dislodge visible soil and blood particles. The
use of cold water during this stage avoids blood clotting or the formation of protein
prions. At the end of pre-wash, the tank fluids are drained.
The tank is refilled from hot and cold inlets. A dose of chemical is dispensed and
mixed with the tank water. When the tank is full, the fluids are heated to +40 °C
(+104 °F) and ultrasonics remove any dissolved gases. Washing alternates
between ultrasonic irrigation and lumen flushing and spraying. At the end of
washing, the tank fluids are drained.
The tank is then refilled for final rinsing and heated to +40 °C (+104 °F). This
temperature is maintained for 2 minutes. Rinsing removes chemical and any
remaining soil from instruments. Tank is drained after final rinsing and wash
program is completed.
This wash program is locked and can only be adjusted by a manufacturer-approved
service technician.
Table 13.2 Complete Wash Cycle Program Settings
Program number P1
Program name Complete Wash Cycle
Supervisor editable no (locked)
Stage Parameter Factory setting
Duration 3 minutes
Pre-wash
Times performed 1 time
Degassing Duration 5 minutes
Chemical dose 160 ml (5.41 fl.oz)
Washing Temperature +40 °C (+104 °F)
Duration 10 minutes
Temperature +40 °C (+104 °F)
Final Rinse
Duration 2 minutes
WASH PROGRAMS 107

13.3 Wash Only Program

The factory-set Wash Only program is intended for the processing of heavily-soiled
instruments or as a quick wash process before full cleaning.
There is no pre- soak stage and the program proceeds immediately to the main
wash stage.
The tank is filled from hot and cold inlets. Chemical is dispensed and mixed with the
tank water. When the tank is full, the fluids are heated to +40 °C (+104 °F) and
ultrasonics remove any dissolved gases. Washing alternates between ultrasonic
irrigation and lumen flushing and spraying. At the end of washing, the tank fluids are
drained and the wash program is completed.
There is no rinse operation after the washing stage so instruments will require
further processing to remove detergent and any remaining soil.
service technician.
Table 13.3 Wash Only Program Settings
Program number P2
Program name Wash Only
Duration 10 minutes
108 WASH PROGRAMS

13.4 Open Programs

Three wash programs are populated with default Openwash program parameters.
These wash program parameters can adjusted within the supervisor menu to
create customer-specific wash program requirements.
To edit program parameters see Viewing and Editing Wash Program Parameters
on page 84.
Table 13.4 Open Program Settings
Program numbers P3, P4, P5

Program name Open
Supervisor editable yes (unlocked)
Stage Parameter Default setting
Duration 0 minutes
Pre-wash
Washes 1
Detergent dose 160 ml (5.41 fl.oz)
Duration 0 minutes
WASH PROGRAMS 109

13.5 Decontamination Program

The factory- set Decontamination program can be used to perform a full
decontamination of equipment, following the procedure described in Performing a
Full Decontamination on page 77.
service technician.
Table 13.5 Decontamination Program Settings
Program number P6
Program name Decontamination
Duration 3 minutes
Pre-wash
Times performed 1 time
Duration 15 minutes
110 WASH PROGRAMS

CHAPTER 14
Specification
This chapter provides information on the performance and physical specifications of the
equipment.
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
SPECIFICATION 111
14.1 Performance
Equipment designation Healthcare sonic irrigator

Classifications Medical device class I
Class 1 electrical shock protection, externally powered
No applied parts
IP rating: IPX0
Not suitable for use in oxygen-rich environment
Designed for continuous use
Intended purpose Internal and external cleaning of surgical instruments,
hollow-ware and associated products.
Operating process Ultrasonic activity, irrigation ports, and water heating.
Ultrasonic system 10 piezoelectric transducers, typically operating at 38 kHz
to 40 kHz dependent on load.
40 W power per transducer.
Pulsed degas, auto-tune, frequency sweep
Irrigation system 3-port flush manifolds in 2 corners of the basket, producing
up to 1.5 bar (22.0 psi) at a flow rate of 2.9 liters/min.
(98.1 US fl.oz/min.)
Water temperature monitoring Measurement range: +2 ºC to +60 ºC (+36 ºF to +140 ºF)
Temp. display: +5 ºC to+ 60 ºC (+41 ºF to +140 ºF)
Measurement accuracy: ±0.5 ºC (±0.9 ºF).
User interface 4.3 in. TFT touch-screen display
Audio 1 W speaker
Time Control accuracy: ±0.5 second.
Display: Minutes and seconds.
Internal data storage Micro SD flash card, >4 GB (storage of >10,000 cycles)
Real-time clock battery CR1220 (5012LC), 35 mAh to 40 mAh, 0.1 mA
112 SPECIFICATION
14.2 Electrical Supply Requirements
All model variants Mains supply voltage fluctuations up to ±10%

of nominal voltage
Transient over- voltages typically present on
mains supply (Over-voltage Category II)
Pollution Degree 2
Power: 1.2 kW
IW522015-, Voltage: 110 Vac 1P+N (100 Vac to 127 Vac)
MED522015-, MED11161- Frequency: 50 Hz
IWULTRAPL, IW 522026-, Voltage: 110 Vac 1P+N (100 Vac to 127 Vac)


14.3 Water Supply Requirements
Requirement
Pressure 2.0 bar to 5.0 bar (30 psi to 70 psi)
Flow rate 11 liters/min. to 30 liters/min.
(3 US gal/min.to 8 US gal/min.)
Temperature Cold: +5 ºC to +30 ºC (+41 ºF to +86 ºF)
Hot: +50 ºC to +80 ºC (+122 ºF to +176 ºF)
Connection 3/4 in. BSP male thread
Position Within 1 m (3 ft) of proposed unit location
SPECIFICATION 113
14.4 Site Drain Requirements
Requirement
Drain connection 19 mm (3/4 in.) hose tail outlet from unit. Drain must be
fitted with suitable traps. No loops in the drain hose, cut
the hose to length to required.
Overflow connection 48 mm (1.9 in.) outside diameter connection from sonic
irrigator. The overflow hose connection to main drainage
must maintain an air gap and not be airtight.
Position Drain entry and entire drain hose must be below drain
outlet on equipment. Drain gully pipe internal diameter
must be at least 100 mm (4 in.)
Capacity > 15 liters/min. (> 4 US gal/min.)
Effluent temperature Up to +60 ºC ( +140 ºF)
14.5 Overall Dimensions and Weight
metric US Units
External height (lid closed) 379 mm 15.6 in.
External height (lid open) 739 mm 29.0 in.
External width 748 mm 29.5 in.
External depth 534 mm 21.0 in.
Net weight (dry) 39.5 kg 87.0 lb
Maximum Operating weight
55.0 kg 121.3 lb
(with basket fully loaded)
14.6 Tank Dimensions and Capacity
Metric US Units
Length 651 mm 25.6 in.
Width 291 mm 11.5 in.
Depth 206 mm 8.1 in.
Maximum liquid volume 22.5 liters 6.0 US gal
Total volume 39.0 liters 10.0 US gal
114 SPECIFICATION
14.7 Basket Dimensions and Capacity
Metric US Units
Basket length 484 mm 19.0 in.
Basket width 253 mm 10.0 in.
Basket depth 76 mm 3.0 in.
Maximum load weight 5.0 kg 11.0 lb
Maximum luer 12 (6 ports connected to 'Y' adapted hoses)
connections
14.8 Languages
The ultrasonic cleaner language, for the display and wash cycle logs, can be set to
any of the following:
Available Languages
English Italian Polish
Danish Japanese Portuguese
Finnish Latvian Russian
French Lithuanian Spanish
German Norwegian Swedish
14.9 Environmental Performance
Altitude range Interior only, altitude up to 2000 m (6562 ft)

Ambient operating
+5 ºC to +40 ºC (+41 ºF to +104 ºF)
temperature range
80% relative humidity for up to +31 ºC (+88 ºF)
Maximum humidity decreasing linearly to 50% relative humidity at +40 ºC
(+104 ºF)
Noise generated
71 dBA at distance of 1 m (3.3 ft) from front of equipment
during operation
SPECIFICATION 115
CHAPTER 15
Terms, Definitions, and Symbols

This chapter details terms and definitions used throughout this manual, and symbols which
may appear on the equipment.
15.1 Terms and Definitions 118
15.2 Visual Symbols 126
TERMS, DEFINITIONS, AND SYMBOLS 117

15.1 Terms and Definitions

The terms, as defined below, may appear throughout this manual.
Abort, Aborting
Stopping wash cycle quickly and not allowing equipment to complete the wash program.
Accessories
Optional devices or fittings that can be used with, or extend the functionality of equipment.
Additives
Chemicals and detergents used with equipment to achieve optimal cleaning performance.
Basket
A perforated stainless steel deep tray or frame, designed to hold or contain instruments during
wash operation.
Cannulated
A thin tube or vessel feature.
Caution
Advice alerting personnel to a risk that can potentially damage equipment.
118 TERMS, DEFINITIONS, AND SYMBOLS

Cavitation
The foundation of ultrasonic cleaning occurs when ultrasonic energy is introduced into a cleaning
solution. This energy causes alternating low and high pressure phases. During low pressure
phases, minute bubbles (or vacuum cavities) are formed: during high pressure phases, bubbles
implode violently.
Chamber
Large cavity within equipment where instruments are washed. Also refered to as "tank".
Chemical
A water-soluble substance used to assist cleaning during a wash cycle. Often refers to the use of
"detergent".
Chemical pickup
Hose assembly that connects to chemical port at the back of the sonic irrigator and is fed into a
chemical bottle. The hose assembly provides chemical (detergent) to the sonic irrigator as
demanded by wash settings.
Chemical pump
Internal pump used to deliver detergent into the tank.
Concentration
A measure of the amount of dissolved substance contained per unit of volume.
Cycle
A sequence of actions that equipment performs in order to clean instruments. Also referred to as a
"program".
Degas, Degassing
An action where sonics are used to remove dissolved gases of water in tank. Degassing is
normally performed at beginning of main wash cycle stage.

Detergent
A water-soluble cleansing agent which combines with impurities and dirt to make them more
soluble.
Dispensing, Dispensation
The action of chemical being transported, in controlled measure, from chemical bottle into tank.
Distal connector
A special connector that attaches to, and facilitates, flushing through hollow and cannulated
instruments.
Drain
Feature of equipment designed to allow waste fluids empty from the tank and into a site waste
water facility.
Effluent
Waste fluids, expelled from tank when a draining action is performed.
Flush, Flushing
The action of pushing washing fluids through a hollow vessel or instrument.
Instrument
Miscellaneous medical tools, such a as clamps, scissors, spreaders and picks that require
cleaning before reuse.

Irrigation
Process of cleaning instruments through the use of controlled water flow and/or spray. See also
"flushing".
Loading
Placing (and/or connecting) instruments to be processed within the equipment basket and then
putting basket inside tank.
Locked
Describes factory-set parameters and wash programs that cannot be edited by operators or
supervisors.
Log
A record of key wash cycle information. The record of wash cycle information
Luer hose
A hose that connects to either instrument port or to distal connector to facilitate flushing.
Lumen
A hollow channel or narrow cavity. May refer to feature within medical instuments and/or
connectors to such intruments.
Maintenance
Periodic actions required to keep equipment in such condition that it may be utilized, at its original
or designed capacity and efficiency, and for its intended purpose.
Manifold
Normally located in the basket, a manifold provides connection to flushing feature of equipment.
Each manifold will have a set number of luer connection ports.

Operator
Person using equipment according to its intended purpose, as part of their regular work actvity.
Overflow
An equipment feature that ensures fluid flows to drain in the event that tank is overfilled, and does
not spill over unit or floor.
Parameter(s)
Settings within the equipment that govern important aspects of the cycle, such as wash
temperature, degassing duration, and wash duration.
Precaution
Describes an action or measure taken in advance to avert or minimise the risk of harm to persons,
and/or damage to equipment.
Prewash
A preliminary washing action, performed before washing actions, to remove less-stubborn
contaminants from instruments.
Prime, Priming
An action that fills chemical pump and hoses from chemical bottle to tank inlet with chemical. This
ensures the correct dose of chemical will be delivered when demanded by wash cycle actions.
Processing
A general term used to describe a series of actions intended to clean instruments, or prepare
intsruments for secondary cleaning using other equipment.

Program
A sequence of actions that equipment performs in order to clean instruments. Also referred to as a
"cycle".
Protective Earth
An earth ground connection to physical ground. When a fault occurs, current flows from the power
system to earth.
Recirculation
Fluids in the tank are pumped through the basket manifold and into connected luer hoses. This
fluid then returns to the tank. Recirculating tank fluids are used for flushing of instruments.
Rewash
Washing water is reused for multiple wash cycles, as defined within cycle settings setup by
operator with supervisor access.
Servicing
Performed by an approved technician: A periodic adjustment and calibration, along with
replacement of parts, to ensure that equipment continues to perform at an optimal level.
Set Point
The temperature parameter within a wash program that is used alongside temperature sensors to
control heating of tank fluids.
Solution
A substance dissolved in a liquid, normally water.

Sonic irrigation
The use of ultrasonic waves to dislodge contaminants from instrument surfaces, and flushing to
remove debris from instruments.
Supervisor
An operator who is able to access Supervisor Menu by using a valid supervisor identification
number.
Tank
Cavity within unit where instruments are washed. Also referred to as "chamber".
Transducers
Electromechanical component of equipment generating ultrasonic vibrations.
Troubleshooting
Diagnosing performance issues and reported problems, and taking remedial action.
Ultrasonic
Vibration waves in the high frequency range (greater than 20 kHz).
Vapor
Gaseous particles that may be emitted from a liquid at room temperature or when heated.

Warning
Advice alerting of a danger that can potentially cause personal injury or death.

15.2 Visual Symbols

The following symbols may appear on the equipment:
Table 15.1 Visual Symbols

Symbol Description
UL Listed Mark
Certifies that this equipment meets the requirements and standards of
Underwriters Laboratories (UL). Accompanied by the UL listing reference.
FCC Declaration of Conformity
Certifies that electromagnetic interference from this device is under the limits
approved by the Federal Communications Commission.
CE Mark
Certifies that this equipment conforms with health, safety, and environmental
production standards for products sold within the European Community.
Protective Earth Ground

Indicates an electrical connection to ground on the equipment.
Electric Shock Hazard

Refer to the operator manual for further details on electrical hazards
associated with this equipment.
Electrical Power Requirement of Equipment
Refer to operator manual for further information on the electrical power and
electrical connection requirements for this equipment.
Hazard (Warning, Caution)
Refer to the operator manual for further details on hazards associated with
this equipment.
Date of Manufacture
Accompanied by the date of manufacture.
Manufacturer Details
Accompanied by the name and address of the manufacturer.
Authorized Representative in the European Community

Accompanied by name and address of the manufacturer's authorized
representative within the European Community.
Swiss Authorized Representative
Accompanied by name and address of the manufacturer's Swiss Authorized
Representative.

Table 15.1 Visual Symbols (continued)

Symbol Description
Importer
When appearing adjacent to Authorized Representative name and address,
confirms that the stated Representative is an importer of medical devices.
UK Conformity Assessed Mark
A conformity mark that indicates conformity with the applicable requirements
for products sold within Great Britain.
Unique Device Identification
The labeling on this equipment adheres to the UDI system labeling as defined
by the FCC.
Manufacturer Catalog Number

Accompanied by the manufacturer code unique to equipment model.
Manufacturer Serial Number

Accompanied by the manufacturer code unique to this equipment.
Medical Device
Indicates that this equipment is a medical device, as defined by the Medical
Device Regulations (MDR) 2017/745.
Consult Instructions
Read the manual(s) shipped withthis equipment before attempting to install or
operate.
Consult Instructions
Read the manual(s) shipped with this equipment before attempting to install
or operate.
Directive on Waste Electrical and Electronic Equipment (WEEE)

Follow the Directive for WEEE in disposal of this equipment.

Appendices
Appendix A: Service Record 130
Appendix B: Training Records 131
Appendix C: Decontamination Certificate 133
Appendix D: Operator and Supervisor Authorization Codes 135
APPENDICES 129
Operator Manual InnoWave Ultra+ Sonic Irrigator
Appendix A: Service Record

The table below should be updated whenever this equipment is serviced, and made available
in the event of a warranty claim or a breakdown repair.
6-Month Service 12-Month Service
Serviced by Serviced by
Cycles since last service Cycles since last service
Next service due Next service due
18-Month Service 2-Year Service
2.5-Year Service 3-Year Service
130 APPENDICES
Appendix B: Training Records

The table below can be used for keeping training records.
Date Name Title of training Signature of

trainer
APPENDICES 131
Appendix C: Decontamination Certificate
IMPORTANT
A full decontamination MUST be done when shipping equipment to supplier
for any reason, including returns for repair or servicing. If a completed
Decontamination Certificate is not visible on outside of shipping crate, courier
and/or supplier CAN REFUSE to accept item(s).
DECONTAMINATION CERTIFICATE
I hereby certify that the equipment referred to in this document by model

and serial number, has been disinfected in accordance with hospital
procedures.
Model no.: ...........................................................................................................
Serial no.: ...........................................................................................................
Hospital: ...........................................................................................................
Name: ...........................................................................................................
Signature: ................................... Date: ..............................
Promoting a clean and safe service
APPENDICES 133
Appendix D: Operator and Supervisor Authorization Codes

There are 80 operator numbers each with unique PIN.
Operator PIN Operator PIN Operator PIN Operator PIN
1 2040 21 4060 41 6080 61 8020
2 2181 22 4121 42 6141 62 8161
3 2262 23 4282 43 6222 63 8242
4 2263 24 4383 44 6323 64 8343
5 2484 25 4424 45 6444 65 8464
6 2545 26 4565 46 6585 66 8525
7 2626 27 4646 47 6666 67 8686
8 2727 28 4747 48 6776 68 8787
9 2848 29 4868 49 6888 69 8828
10 2989 30 4929 50 6949 70 8969
11 3070 31 5090 51 7030 71 9050
12 3171 32 5191 52 7131 72 9151
13 3292 33 5232 53 7252 73 9272
14 3353 34 5373 54 7393 74 9333
15 3434 35 5454 55 7474 75 9494
16 3535 36 5555 56 7575 76 9995
17 3656 37 5676 57 7696 77 9636
18 3797 38 5737 58 7757 78 9777
19 3878 39 5898 59 7838 79 9858
20 3979 40 5999 60 7939 80 9959
Supervisor Authorization Code

The supervisor pin when shipped is 123456. To change the supervisor pin, see Changing the
Supervisor PIN on page 83.
APPENDICES 135
InnoWave Ultra+ Sonic Irrigator
Index
Classifications 112
A Cleaning See Maintenance
Compliance 14, 16
Aborting wash cycle See Wash cycle Contact details i, 104
Accessories ii, 6, 39, 79
Applied standards See Standards
D
Audio 112
Date (adjusting) See Time and Date

B Date of manufacture 13, 126
Decontamination
Basket Certificate 79, 133
cannulated instruments loading 49 full decontamination ii, 76-77, 110, 133
capacity 115 Degassing See Wash cycle
dimensions 115 Designation 112
docking in tank 47, 52, 60, 78 Detergent See Chemicals
flush ports 55, 78 Display (touchscreen) iii, iii, 31-35, 43, 59-
general instruments loading 49 60, 62-64, 69, 76-78, 82-84, 87-88,
instrument organizer 18, 79 93, 96, 100, 106, 112, 115
load weight 115 entering operator PIN (unlocking) 33
loading 34, 59-60, 63-64 menu navigation 33
manifolds 20, 36, 49, 78, 103
Disposal of equipment 16
removing 4, 27, 48, 62, 69, 74
Distal connectors 49, 78
unloading 47, 55
Drain
capacity 112-114
C connecting drain hose 23
drain hose 19, 23, 79, 96, 102, 114
effluent temperature 114
Chemical bottle 34, 38, 41-42, 73, 77, 102 filter 20, 27, 52, 75, 79
Chemical dose 104, 107-108, 110 outlet 24, 114
Chemical pickup ii, 19-20, 38, 40, 42, 77, site requirements iii, 17, 25, 27, 96, 102,
79, 102 114
Chemical port 20, 41, 60, 77
Chemical pump 34, 42
Chemicals E
detergent 2, 12, 40, 43, 108-109
disinfection solution 77 Electrical power 13, 28, 100, 126
priming chemical pump 42 fuses 6, 100
recommended ii, 6, 39, 79, 103 protective earth 3, 126
safety data sheet (SDS) 3, 38, 41 supply voltage 99, 113
Circulation pump 36 Enclosed items 17-18
INDEX 137
Environment Lid
altitude range 115 cleaning 58, 73
ambient operating temperature 115 inspection 73
maximum humidity 115 magnet 58, 73
noise generated 115 opening 18, 27, 43, 48, 58, 62, 69, 73
Errors See Troubleshooting seal 58, 73, 101
Lifting (equipment) See Transportation
Luer hoses 18, 49, 55, 63, 78
F
Features of equipment 12
M
Flushing See Wash cycle
Maintenance
cleaning (daily) iii, 69, 73, 76-77
H cleaning (weekly) 76
Manufacturer information ii, 13
Hose clamps 19, 24, 26 Menu
main menu 34, 87-88
supervisor menu iii, 34, 61, 68, 78, 81-
I 84, 87-88, 106, 109
Indentification (of equipment) ii, 13

O
Inspection See Maintenance
Instruments
box-jointed 5 Operator Authorization 135
cannulated 46, 49 Overflow hose iii, 19, 26, 79, 114
care 5
general 46, 49
loading cannulated instruments 49 P
loading general instruments 49
removing 63, 69 Pausing wash cycle See Wash cycle
Intended purpose 12, 112 Performance iii, 4, 39, 46, 71-72, 75, 79-
Internal data storage 112 80, 95, 100, 111-112, 115
Irrigation system iii, 112 troubleshooting iii, 95, 100
PIN number
operator codes 135
L
operator PIN 32
supervisor PIN 34, 82-84, 87-88, 135
Language Power-on self-test (POST) 29
available languages 89, 115 Power switch 20
changing 88 Prewash See Wash cycle
Priming chemical pump See Chemicals
138 INDEX
Printer cable 20
Progress bar 35, 93 T
Tank
R
dimensions 114
docking ports 52, 74
Recirculation filter 20, 27, 52, 58, 74, 79 maximum liquid volume 114
inspection 58, 74 Time and Date
replacing 58 clock battery 112
Replacement parts 6, 39, 79 control accuracy 112
Restriction of Hazardous Substances date adjustment 77
(RoHS) 15 time adjustment 76
Rewash Training
on completion of cycle iii, 68-69 recommended 9
rewash counter 68-69 records 9, 131
setting 68 Transportation 7
Rinsing See Wash cycle lifting 7, 48
storage 7, 112
Troubleshooting
S "check chemical" message 102
"Wipe fill sensors" message 100
Safety precautions 2, 72 error codes 64, 100
breathing hazard 2
burn hazard 4, 48, 62, 69
chemical burn hazard 3, 38, 41
U
chemical hazard 5, 38
electric shock hazard 3, 126 Ultrasonic system iii, 112
equipment damage hazard 4 Unpacking 18
explosion hazard 2
USB
eye injury hazard 3, 38, 41
data port 20, 94
protective equipment (PPE) 3, 7, 38, 41
downloading logs ii, 93
slipping hazard 5
USB flash drive ii, 12, 20, 34, 91, 93
Serial number 13, 34, 94, 127, 133
User interface 112
Servicing 2, 7, 38, 41, 73, 80, 133
record 80, 130
schedule 80 V
Specification 111
Standards iii, 14, 126
Visual symbols 126
Storage See Transportation
INDEX 139
Wash cycle
abort 46, 64
completion 62
degassing 36, 61, 85, 98, 107-110
downloading onto USB drive ii
errors ii, 46, 64
flushing 36, 46, 49, 61, 107-108
information on display during cycle 35
pausing 35, 63
sonics 36
stages 61
starting 34, 60
Wash programs 34-35, 38, 59-61, 78, 84,
98, 102, 106-108, 110
Complete wash cycle 62, 106-107
Decontamination 78
rewash program ii, 58, 62, 67-69, 73, 76,
86
viewing program settings 68, 84
Water
connection type 113
flow rate (supply) iii, 98, 112-113
heater 35
level sensors 36, 99
pressure (supply) 8, 47, 87, 101, 113
temperature iii, 4, 48, 62, 68-69, 85, 97,
112
water hoses 21-22
Weight
maximum load 115
maximum operating 114
140 INDEX

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InnoWave™ Ultra+ Sonic Irrigator

Publication Title InnoWave Ultra+ Sonic Irrigator Operator Manual

Models Covered IWULTRAPL

COPYRIGHT © 2023 STERIS. ALL RIGHTS RESERVED.

LIMITED RIGHTS NOTICE TECHNICAL DOCUMENTATION/DATA:

1 06 Sep 2017 First release.

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.

Revision Date Summary

Connecting the Equipment

Using the Touchscreen Display

5.1 Use of Chemicals 38

Using the Instrument Basket

Performing a Wash Cycle

The Rewash Feature

9.6 Accessories and Replacement Parts 79

The Supervisor Menu

Wash Cycle Logs

TABLE OF CONTENTS vii

13.5 Decontamination Program 110

Terms, Definitions, and Symbols

viii TABLE OF CONTENTS

CAUTION — Read this section

This chapter contains important safety information about the equipment.

1.1 Safety Precautions

WARNING — Explosion hazard

WARNING — Breathing hazard

WARNING — Electric shock hazard

WARNING — Chemical burn and/or eye injury hazard

WARNING — Burn hazard

WARNING — Personal injury and/or equipment damage hazard

WARNING — Slipping hazard

WARNING — No user-serviceable parts

CAUTION — Chemical hazard

CAUTION — Instrument Care

CAUTION — Equipment damage

1.2 Personal Protective Equipment

Goggles / safety glasses

Boots with toe protection

1.3 Transportation and Storage

1.3.2 Storage Markings

1.3.3 Environmental Conditions

1.3.4 Environmental Conditions

1.4 Recommended Operator Training

It is recommended that operator training should cover, as a minimum, the following

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

2.7 Applied Standards 14

2.8 RoHS Requirements 15

2.9 Disposal of equipment 16

2.1 Intended Purpose of Equipment

2.2 Equipment Features