InnoWave PRO User Manual_EN

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InnoWave™ Pro

Sonic Irrigator
User Manual
InnoWaveTM Pro

Record of Revisions

REVISION
DESCRIPTION BY DATE
NUMBER
1 Original Issue W. Leslie 22-Feb-17
2 - W. Leslie 05-Apr-17
3 Copyright text and record of revision table added.
General Spec update. Daily/weekly checks and E. de Bruijn 07-Nov-18
decontamination updated
4 Machine label updated. Applied Standards
updated. Visual Symbols updated. Added RoHS J. Slater 28 Nov 2018
Requirements.
5 Document formatting only J. Slater 30 Nov 2018
6 Label and Manufacture address update Brexit E. de Bruijn 12 Feb 2018

COPYRIGHT© 2018 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.

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Table of Contents
1 INTRODUCTION ....................................................................................................................................... 5

1.1 STERIS CONTACT DETAILS...................................................................................................................... 6


1.2 INTRODUCTION ..................................................................................................................................... 7
1.2.1 Independent Monitoring ................................................................................................. 7
1.2.2 Service and Maintenance Requirements ......................................................................... 7
1.3 SAFETY PRECAUTIONS ............................................................................................................................ 8
1.4 TRAINING PERSONNEL .......................................................................................................................... 11
1.5 COMPLIANCE...................................................................................................................................... 12
1.6 DISPOSAL .......................................................................................................................................... 12
1.7 ROHS REQUIREMENTS ......................................................................................................................... 12
1.8 PRODUCT IDENTITY.............................................................................................................................. 12
1.9 MANUFACTURER INFORMATION ............................................................................................................ 12
1.10 INTENDED USE.................................................................................................................................... 13
1.11 PERFORMANCE ................................................................................................................................... 13
1.12 CYCLE RECORD ................................................................................................................................... 13
1.13 OVERVIEW ......................................................................................................................................... 13
1.14 GENERAL SAFETY ................................................................................................................................ 14
1.14.1 Chemicals ...................................................................................................................... 14
1.14.2 Decontamination........................................................................................................... 14
1.14.3 Heat ............................................................................................................................... 14
1.14.4 Electrical Safety ............................................................................................................. 14

2 INSTALLATION ....................................................................................................................................... 15

2.1 TRANSPORT AND STORAGE.................................................................................................................... 16


2.1.1 Marking ......................................................................................................................... 16
2.1.2 Environmental ............................................................................................................... 16
2.2 LIFTING ............................................................................................................................................. 16
2.3 UNPACKING ....................................................................................................................................... 16
2.4 RETURNS ........................................................................................................................................... 16
2.5 ENCLOSURES CHECK LIST ...................................................................................................................... 17
2.5.1 Accessory Kit (MP21223) ............................................................................................... 17
2.5.2 Plumbing Kit (MP21225) ............................................................................................... 17
2.6 ADDITIONAL ACCESSORIES .................................................................................................................... 18
2.6.1 Recommended Chemistries ........................................................................................... 18
2.7 INSTALLATION REQUIREMENTS............................................................................................................... 19
2.8 CONNECTING THE INNOWAVE PRO ........................................................................................................ 21
2.9 INSTALLATION CHECKLIST ...................................................................................................................... 22
2.10 INSTALLATION DRAWINGS ..................................................................................................................... 24
2.10.1 Rear View Showing Services .......................................................................................... 24
2.10.2 Front View ..................................................................................................................... 25
2.10.3 Left Side View with Lid Closed showing Drain Connection ............................................ 26
2.10.4 Left Side View Lid Open ................................................................................................. 27

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3 OPERATION ........................................................................................................................................... 29

3.1 MENU .............................................................................................................................................. 30


3.2 POWER UP ........................................................................................................................................ 31
3.3 AUTHORIZATION CODE ......................................................................................................................... 31
3.4 SETTING TIME & DATE ......................................................................................................................... 32
3.4.1 Set Time ......................................................................................................................... 32
3.4.2 Set Date ......................................................................................................................... 32
3.5 SELECTING A PROGRAM ........................................................................................................................ 33
3.5.1 Standard Program Parameters ..................................................................................... 33
3.6 CHEMICAL HANDLING .......................................................................................................................... 34
3.6.1 Chemistry Sensing ......................................................................................................... 34
3.6.2 Chemical Replacement .................................................................................................. 34
3.6.3 Disposal of chemical containers .................................................................................... 34
3.6.4 Chemical Priming........................................................................................................... 34
3.7 BASKETS ............................................................................................................................................ 35
3.7.1 Basket Removal ............................................................................................................. 35
3.7.2 Basket Insertion ............................................................................................................. 35
3.7.3 Instruments ................................................................................................................... 36
3.7.4 Instrument Loading Precautions ................................................................................... 36
3.7.5 Carrier Lift Controls ....................................................................................................... 37
3.7.6 Light Guard .................................................................................................................... 37
3.7.7 Safety Edge .................................................................................................................... 37
3.7.8 Emergency Stop ............................................................................................................. 37
3.7.9 Testing Operation of the Safety Devices ....................................................................... 38
3.8 STARTING A CYCLE............................................................................................................................... 39
3.9 AUTOMATED WASH CYCLE ................................................................................................................... 40
3.9.1 Cycle Process ................................................................................................................. 40
3.9.2 Pre-wash........................................................................................................................ 41
3.9.3 Wash ............................................................................................................................. 41
3.9.4 Rinse .............................................................................................................................. 42
3.9.5 Final Rinse/Disinfection ................................................................................................. 42
3.9.6 Cooling........................................................................................................................... 43
3.9.7 Drying ............................................................................................................................ 43
3.9.8 Cycle Complete .............................................................................................................. 43
3.9.9 Unload ........................................................................................................................... 43
3.9.10 Re-Wash Cycle ............................................................................................................... 44
3.10 CYCLE ERRORS .................................................................................................................................... 45
3.11 ABORTING A CYCLE .............................................................................................................................. 45
3.12 LED EDGE ......................................................................................................................................... 45
3.13 DOWNLOADING THE CYCLE LOG ............................................................................................................. 46
3.13.1 Download Logs .............................................................................................................. 46
3.14 SUPERVISOR MENU ............................................................................................................................. 47
3.14.1 Open the Supervisor Menu: ........................................................................................... 47
3.14.2 Program Editor/Viewer ................................................................................................. 47
3.14.3 Change PIN Code ........................................................................................................... 49
3.14.4 Exit the Supervisor Menu............................................................................................... 49
3.15 ROUTINE MAINTENANCE ...................................................................................................................... 50
3.15.1 Before Every Cycle ......................................................................................................... 51
3.15.2 Daily Checks................................................................................................................... 52

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3.15.3 Weekly checks ............................................................................................................... 53
3.16 DECONTAMINATION GUIDE ................................................................................................................... 54
3.16.1 Daily Cleaning/Procedure .............................................................................................. 54
3.16.2 Full Decontamination .................................................................................................... 54
3.16.3 Pre-Transport Procedure ............................................................................................... 54
3.16.4 Decontamination Certificate ......................................................................................... 55

4 TROUBLESHOOTING .............................................................................................................................. 57

4.1 ERROR MESSAGES ............................................................................................................................... 58


4.2 OTHER FAULTS ................................................................................................................................... 60

5 TECHNICAL ............................................................................................................................................ 61

5.1 GENERAL SPECIFICATIONS ..................................................................................................................... 62


5.2 APPLIED STANDARDS ........................................................................................................................... 65

6 APPENDICES .......................................................................................................................................... 67

6.1 EMC ................................................................................................................................................ 68


6.1.1 EMC & Electromagnetic Compatibility Data ................................................................. 68
6.1.2 Electromagnetic Emissions ............................................................................................ 69
6.1.3 Electromagnetic Immunity ............................................................................................ 70
6.1.4 Separation Distances Between InnoWave Pro and Mobile RF Equipment .................... 72
6.2 WARRANTY AND DISCLAIMERS............................................................................................................... 73
6.3 SERVICE RECORD................................................................................................................................. 74
6.4 OPERATOR PIN NUMBER CODES ........................................................................................................... 75
6.5 SYMBOLS GLOSSARY ............................................................................................................................ 76

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1. Introduction

1 Introduction
User Manual

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1.1. STERIS Contact Details

(Sales, Customer Service & Technical Support)

STERIS Corporation
5960 Heisley Rd
Mentor, OH 44060, USA

Tel: 800-548-4873
www.STERIS.com

(Manufacturing)

Unit 1 Twyford Industrial Estate


Twyford Road
Bishop’s Stortford Hertfordshire
CM23 3LJ
UK

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1.2 Introduction

Important
Read this entire manual before attempting to install, operate or perform any maintenance
on the InnoWave Pro Sonic Irrigator. Ensure all appropriate personnel understand the
contents of the InnoWave™ Pro Sonic Irrigator manual.

This Operating Manual contains important information on proper use and maintenance of the InnoWave
Pro Sonic Irrigator. All personnel involved in the use and maintenance of this equipment must carefully
review and comply with the warnings, cautions and instructions contained in this manual. These
instructions are important to protect the health and safety of personnel operating the InnoWave Pro
Sonic Irrigator and should be retained in a conveniently accessible area for quick reference.

Advisory
A listing of the Safety Precautions to be observed when operating the InnoWave Pro Sonic Irrigator is
found in Section 1-4 of this manual. Do not operate the equipment until you have become familiar with
this information.

1.2.1 Independent Monitoring


Important Note for the Product Owner
It is advised that an independent monitoring system is fitted in accordance with ANSI/AAMI ST 15883-
1:2009 - Washer-disinfectors.

1.2.2 Service and Maintenance Requirements


The InnoWave Pro should be serviced on a regular basis to ensure that the product continues to perform
in accordance with its performance specifications. See section 6-6 for more information.

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1.3 Safety Precautions

The following Safety Precautions must be observed when operating or servicing the InnoWave Pro.
WARNING indicates the potential for personal injury and CAUTION indicates the potential for damage
to equipment. For emphasis, certain Safety Precautions are repeated throughout the manual. It is
important to review ALL Safety Precautions before operating or servicing the unit.

Warning – Pinching Hazard

Pinch points are created during lid articulation. Keep hands clear when opening or
closing the lid.

In the unlikely event of an uncontrolled fault, the emergency stop button can be
pushed to cut power for the Carrier Lift and other critical outputs.

Warning – Breathing Hazard

Some cleaning solutions emit harmful vapors. Only use cleaning solutions in well-
ventilated areas. Do not inhale vapors. Do not permit solution vapors to exceed
maximum allowable concentrations in the work area. Ensure adequate ventilation.

Warning – Chemical Burn and/or Eye Injury Hazard

• Detergents are caustic and can cause adverse effects to exposed tissues. Do
not get in eyes, on skin or attempt to ingest by mouth.
• Read and follow precautions and instructions on detergent label and in the
Safety Data Sheet (SDS) prior to handling chemical, refilling chemical
containers or servicing chemical injection pumps and lines.
• Wear appropriate Personal Protective Equipment (PPE) whenever handling
chemicals or servicing chemical injection pumps and lines. This should include
plastic gloves, goggles or full-face visor, and disposable plastic apron.
• Wear appropriate Personal Protective Equipment (PPE) whenever removing
baskets or parts from cleaning chamber.
• In case of body contact with chemical, always follow emergency procedure
given in that chemical’s SDS or call emergency services.

Warning – Burn Hazard

• Since temperatures within the unit can reach 198°F during and after operation,
take care when opening lid at the end of a cycle. Allow sufficient time for items
to cool before handling, cleaning or maintenance procedures.
• Wear appropriate Personal Protective Equipment (PPE) whenever reaching into
Chamber after a thermal disinfection operation.
• Do not attempt to forcibly open the lid during operation under any
circumstances.
• During reloading of instruments in the re-wash program the water temperature
within the unit can reach +140 °F. When opening the lid and reloading the
instruments take care and wear appropriate PPE.

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Warning – Explosion Hazard

Use only water or water-detergent mix in cleaning chamber. Never use flammable
or combustible cleaning liquids. Fire or explosion could result.

Warning – Electric Shock Hazard

• To prevent the risk of fire or electric shock, do not expose equipment to


unnecessary moisture. Always ensure that all external surfaces are dried after
each cycle.
• When removing a basket, allow to drain into the chamber before moving to the
next cleaning station. Excess water spillage may cause electrical shock and
serious injury.
• Disconnect all utilities to unit before servicing. Do not service unit unless all
utilities have been properly locked out. Always follow local occupational health
and safety regulations, as well as electric and plumbing codes.
• Isolate electrical supply by turning the buildings disconnect switch to OFF before
checking or replacing any parts. Electrical shock can cause serious injury.

Warning – Slipping Hazard

To avoid slippery floor conditions, immediately wipe up any spilled liquid or


condensation. If spills or leaks could contain detergents or other chemicals, follow
safety precautions and handling procedures set forth on detergent or chemical
label and/or SDS.

Warning – Personal Injury and/or Equipment Damage Hazard

• Only STERIS or STERIS-trained service personnel must make repairs and


adjustments to this equipment. 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
costly damage. Contact STERIS regarding service options.
• Regularly scheduled preventive maintenance, in addition to the faithful
performance of routine maintenance described within the service manual, is
required for safe and reliable operation of this equipment. Contact STERIS to
schedule preventive maintenance.
• Failure to perform periodic service inspections of the machine could result in
serious personal injury or equipment damage.
• Do not wear loose fitting clothing, neckties or jewelry that could become
entangled in moving parts.
• Never reach into a chamber when unit is in operation.
• Always use a basket to reprocess instruments within the unit.
• Never reach into a chamber if the carrier lift is jammed.

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Caution – Possible Equipment Damage


• Never place items or person(s) on the lid, this is particularly important while
operating the carrier lift.
• Ensure the ball latches in the down position before moving the carrier lift.
• Never place items on the machine which could obstruct the lid from closing.
• Never attempt to obstruct the lid from closing.
• All baskets must be fitted when running a cycle.
• Do not place items directly into the wash tank or allow them to make contact
with the tank sides.
• Never scratch chamber walls. This can increase cavitation erosion.
• Do not load basket with instruments pointing at the lid.
• Do not overload the basket, maximum load of 22 lbs per basket.
• Do not allow Luer pipes to protrude from the basket.
• Always use a Full DIN Tray Standard to hold instruments (M20044).
Caution • When choosing a detergent, select one with a low chloride content. Detergents
with a high chloride content can be harmful to stainless steel.
• Repeated fuse blows or circuit breaker trips indicate a short circuit or overload.
Have a fully trained technician locate and correct situation.
• Use nonabrasive cleaners when cleaning unit. 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 a circular motion or applied
with a wire brush or steel wool will scratch and dull stainless steel.
• Avoid running equipment into the Control Panel or Touch Screen to prevent
damage to controls.
• When removing baskets always tilt down to ensuring any retained water drips
into the tank.
Caution – Chemical

• Chemical bottles must be connected to the correct port. Otherwise, wash


efficiency and/or rinsing will be compromised. Ensure that the chemical type
matches the port shown on the display.
Caution • Check chemical bottles are in date before use

Caution – Instrument Care


• Always confirm compatibility with the instrument manufacturer.
• Always follow the manufacturer’s instructions if processing instruments with
special characteristics e.g. fibre optics or rigid optics.
• Whether pre or post processing instruments, always follow the manufacturer’s
instructions.
• Always attach tubing to a suitable size distal connector for instruments being
cleaned or to a quick connect port if the instrument has one.
• Always open box jointed instruments.
Caution • Always ensure taps are open on cannulated instruments.
• Always disassemble instruments that are designed to be taken apart.
• Visually inspect instruments after reprocessing
• If any instruments became detached from the STERIS connection tubing during
processing, they should be reprocessed after ensuring that the Luer connection
is firmly seated.

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1.4 Training Personnel

The owner of this equipment has the responsibility for training the users and keeping the appropriate
records.

There should be regular training of all personnel concerned with the operation and
maintenance of the equipment. The training schedule shall include:

• Operation of the machine


See section 3-1, 3-4-1, 3-4-2, 3-5, 0, 3-8, 3-9 and 3-12

• Safe use of machine


See section 1-4

• Chemical handing
See section 3-6

• Emergency Procedures
e.g. how to handle the load in case of aborted cycle
See section 3-9-10 and 3-11

• Regular maintenance procedures


See section 3-15 and 3-16

• Troubleshooting
See section 4

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1.5 Compliance 1.8 Product Identity


A stringent quality management system The model and serial number label are located
ensures that every unit is manufactured and on the inside panel of the chemical
tested under controlled conditions to ensure compartment.
that all products perform identically.
The software version is shown on the front
1.6 Disposal panel display when the unit is first switched on.
This product contains materials which may
require disposal through appropriately licensed
and permitted hazardous waste management
firms. 1.9 Manufacturer Information

1.7 RoHS Requirements Manufactured for:


STERIS is committed to meeting or exceeding STERIS Corporation
the requirements of the RoHS CE Marking
Directive, 2011/65/EC (Restirction on the Use 5960 Heisley Rd
of Certain Hazardous Substances in Electrical Mentor, OH 44060, USA
and Electronic Equipment).
Tel: 800-548-4873
www.STERIS.com

Manufactured in:
Unit 1 Twyford Industrial Estate
Twyford Road
Bishop’s Stortford
Hertfordshire, CM23 3LJ
UK

STERIS Ireland Limited


IDA Business and Technology Park
Tullamore, County Offaly
R35 X865, Ireland

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1.10 Intended Use Load Instruments
The STERIS InnoWave Pro Sonic Irrigator is a The user loads the instruments into the basket
high-pressure, ultrasonic, flushing washer using the foot switch to raise and then lower the
disinfector for the healthcare market. It is electrically actuated Carrier Lift in an automated
intended to provide cleaning and intermediate- sequence.
level thermal disinfection of surgical
Prewash
instruments, including lumened devices.
The cycle begins with a cold-water fill to the
This is achieved through a combination of mid-level; the spray and irrigation valves are
ultrasonics and a flushing action to remove opened alternately with the pump running for
debris from both the outside and inside (hollow the specified time. The water is then drained.
instruments only) of items placed within the
wash tank. Wash
Note: If the equipment is used in a manner not At the main wash stage, the tank is filled to the
specified by the manufacturer, the top level with a cold and hot water mix to attain
effectiveness and protection provided by the a set temperature. Detergent is also added at
equipment may be impaired. this point. All cavities are filled and the pump is
pulsed on and off to ensure thorough mixing of
1.11 Performance the chemistry and even temperature
distribution. Once the tank is full the ultrasonics
This machine has a class AB weir incorporated
degas the tank by pulsing on and off to remove
into the tank design to comply with most water
any dissolved air. A period of irrigation follows
authority regulations.
in order to flush any material from inside the
A stringent quality management system instruments. The ultrasonics then alternate with
ensures that every unit is manufactured and irrigation for the set period of time. The water is
tested under controlled conditions to ensure then drained.
that all units perform identically.
Rinse
1.12 Cycle Record The tank is filled with water to the mid-level; the
machine will then alternate between the spray
During the cycle, parameters are reported at
and irrigation for the pre-defined period of time.
key stages of the process. The on-board cycle
The water is then drained.
log can be downloaded via a USB flash drive
(see section 3-13). For some programs this stage is repeated.

Cycle Failure Disinfection


The InnoWave Pro is designed to perform If disinfection is preprogramed (this can also be
within strict and carefully controlled tolerances. set in the customizable programs), the machine
If an unexpected condition occurs during a is then filled to the minimum level with hot water
wash cycle, the system will abort the cycle and and heated up to the pre-set temperature (+
report an error, see section 3-9-10 for more 196 °F) for 3 minutes. The water is then
details. drained.
1.13 Overview Cooling
The InnoWave Pro is a stand-alone high- To disperse the vapor in the chamber, the
pressure sonic irrigator, with the ability to wash machine opens the drain valve and fills with
up to sixty lumens or 66 lbs of general surgical cold water for several minutes.
instruments.
Drying
There are three pre-defined user selectable
programs with Pre-wash, Wash, Rinse and To clear the excess water from the irrigation
Disinfection stages tailored to clean a multitude and spray channels, compressed air is
of different loads. alternately injected at regular intervals.
There are three additional open programs, Unload
where the parameters can be customized within
The user presses the foot switch to open the
specified limits by a supervisor or service
Carrier Lift and unload one level at a time in an
technician, such as stage time, temperature
automated sequence.
and chemistry dosage.

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1.14 General Safety


This equipment is not suitable for use with To avoid risk of electric shock, this equipment
flammable materials or gases, and should not must only be connected by a fully qualified
be used for any purpose other than that defined electrician and to a mains supply with a
by the manufacturer as a high pressure sonic protective earth.
irrigation washer disinfector.
To prevent the risk of fire or electric shock, do
not expose equipment to unnecessary
1.14.1 Chemicals moisture. Always ensure that all external
Since this equipment contains a high-power surfaces are dried after each cycle.
heating device, the use of substances or
chemicals, other than those specified by Hazards can result from
STERIS, may be hazardous. Therefore, always unauthorized modification of the
read the manufacturer’s chemical safety machine. No modification of this
information before use and never use toxic, equipment is allowed. Any
corrosive, or flammable liquids. modification to this equipment will
Using non-recommended chemicals may cause void the warranty.
damage to your machine and could void your
warranty and guarantee of performance.

1.14.2 Decontamination
In the event that this product needs to be
returned to the supplier, it MUST first be fully
decontaminated before transporting. The
Decontamination Certificate (see section 3-16-
4) must also be completed and displayed in a
prominent position when returned with the
product.

1.14.3 Heat
Since temperatures within the unit
can reach (+198 °F) during and after
operation, take care when opening
lid at the end of a cycle. Allow
sufficient time for items to cool
before handling.

1.14.4 Electrical Safety


Dangerously high voltages are
present inside the machine.
Do not remove any paneling,
or attempt to gain access to
the inside of the machine.
Refer servicing and repair to
qualified personnel only.

It is expected that any person


servicing or repairing the InnoWave Pro will be
a competent technician with an understanding
of electrical safety, and knowledge of three
phase power. It is also crucial to understand the
risks of working with electrical appliances that
use water. Caution must be taken at all times to
ensure a safe environment.

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2. Installation

2 Installation
User Manual

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2.1 Transport and Storage 2.2 Lifting


The permissible environmental conditions for Lifting and maneuvering the InnoWave Pro in its
transport and storage of the InnoWave Pro must packing crate must be done using a pallet jack
adhere to the environmental conditions for or forklift truck able to take a load in excess of
altitude, temperature and relative humidity. 1200 lb. Ensure that the forks are evenly spaced,
and central to the machine as shown:

2.1.1 Marking
The markings on the packing crate stipulate the
machine’s storage conditions and handling
information.

Keep dry

Beware: The Load pedal and drain outlet is


vulnerable at this stage. Care must be taken not
to knock or crush it with the forks, as this could
result in irreparable damage to the drain and
This way up’ tank assembly.

2.1.2 Environmental 2.3 Unpacking


This equipment can be transported and stored Retain all packaging materials, if for any reason
safely, in the following environment: the unit needs to be returned to the supplier,
then the original crate and packaging materials
should be re-used.

Carefully unpack your InnoWave Pro by


Temperature Range: removing the top panel first. The front panel of
+36.6 °F to 140 °F the packing crate is designed to be used as a
(+ 2 °C to 60 °C) ramp to aid in getting the machine off the crate.
Once off its base and unpacked, it can then be
moved across a level floor on its castors.

This equipment is not intended to be routinely


moved, wheels are provided only to facilitate
Pressure range installation and servicing by a service technician.
0.5 Bar to 1.06 Bar
(50 kPa to 106 kPa) 2.4 Returns
Before transporting a used InnoWave Pro, it is
vital that all fluid is thoroughly drained from the
machine. If returning the unit to your supplier or
STERIS, it MUST first be fully decontaminated
before transporting.
Humidity range The Decontamination Certificate must also be
30% to 90% RH completed and displayed in a prominent position
(Non-condensing) when returned with the product (see section 3-
16-4).

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2.5 Enclosures Check List


The unit is supplied with a range of accessories to enable easy installation and efficient operation.
Ensure that all these items are present before attempting to install or operate the unit. Complete the
following Enclosures Check List and notify your supplier of any shortages or damaged components as
soon as possible.
The InnoWave Pro comes with three standard baskets, instrument tubing, and distal connectors for
reverse flushing. Replacement items can be ordered, see below list for details.

InnoWave PCF Unit Part Number

IWPRO60

Quantity Part No. Description Checklist ✔

3 MP20111 Standard Basket

1 MP21223 Standard Pro Accessory Kit

2.5.1 Accessory Kit (MP21223)


Quantity Part No. Description Checklist ✔

1 HOSE002 Standard Washing Machine Hose – Blue

2 HOSE007 Stainless Steel Hose Assembly – Red Indicator

3 MP21225 Pro Plumbing Kit

2 MP21224 Chemical Intake Tube

4 MED8558 Jubilee Clip 2-3 inches (50-70mm)

1 MP21006 Elbow Drain Accessory E90-54 ID 2.1inch (54mm)

1 MP21007 Drain Tube Accessory 54mm O/D x 2mm wall (1m)

1 MP20908 2.1inch (54mm) ID Drain Hose 7.8inches (200mm)

2.5.2 Plumbing Kit (MP21225)


Quantity Part No. Description Checklist ✔

2 IW1033 Distal Connector Box of 10 mixed

20 MP21226 Elbow Hose & Luer 9.4 inches (240mm)

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2.6 Additional Accessories
A range of STERIS approved accessories including replacement parts and consumables, may be
purchased from your supplier. The use of these compatible STERIS approved products will ensure the
continued and reliable operation of your machine.

Note: Using non-recommended chemicals, accessories, and replacement parts may cause damage to
the machine and could void both your warranty and your guarantee of performance.

2.6.1 Recommended Chemistries


Selection of chemical additives is open to Customer preference. To achieve optimal performance,
selected chemical additives must meet as a minimum, the following descriptions:

Note: Intuitive Surgical® recommends enzymatic cleaners and automated washer disinfector cleaners
with a neutral to mildly alkaline pH value (pH ≤ 11) and low foaming tendencies (for automated
processes). All cleaners should be prepared with the required dilution and at the temperature
recommended by the manufacturer.

Part No. Description


1031BX Hinge Free® (4 x 1 Gallon)
MEDIS-12041 3E-ZYME Detergent (4 x 1 Gallon)
MEDIS-12042 3E-ZYME Detergent (2 x 2.5 Gallon)
MEDIS-12045 3E-ZYME Detergent (5 Gallon)

Note: Certain products may not be available in your area. Contact STERIS for product availability and
ordering information.

Note: STERIS does not promote, recommend or endorse the use of any type of chemical additives
(strong alkaline detergents [pH>12], alcohol rinses and liquid germicides including hypochlorous acid
[bleach]) in the processing of articles in the InnoWave Pro Sonic Irrigator

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2.7 Installation Requirements

Note: Always follow local occupational health and safety regulations, as well as electric and plumbing
codes.

Machine Position
Level floor and at least 6in away from surrounding walls for ventilation (see section
2-9 for dimensions and clearances).
Site
There should be enough free space provided near the machine for safe and efficient
maintenance in the future.
Ambient Lighting 500 Lux minimum room lighting

Mains Supply
Cables shall be rated for maximum current of the equipment, meeting the requirements of IEC 60227 or IEC
60245. The InnoWave Pro is supplied with 6 ft of screened power cable.

Power cable which must be wired using a plug and socket, conductors color coded as follows:

• Live 1 Black Line


• Live 2 Black Line
• Live 3 Black Line
• Earth Green/Yellow

The cable must be protected with a 3 phase Residual Current Device (RCD) and Miniature Current Breaker
(MCB). The RCD and MCB shall only be used to supply this equipment.

The disconnect switch must:


• Isolate all poles simultaneously
• Be lockable in the off position
• Comply with standards IEC/EN 61058-1 and IEC 60447 (creepage and clearances for 4kV transient
voltage)
• Be situated close to the equipment for ease of accessibility, and in a position where the operator can
turn it off in an emergency without leaning over the machine.
• Marked as the disconnection device for this equipment
• Disconnect device off-position should be clearly marked (O) and the on-position should be marked (l)

To avoid risk of electric shock, this equipment must only be connected by a fully qualified
electrician and to a mains supply with a protective earth/ground.
.
Supply Voltage See section 5-1
< 6 ft from power cable exit. (Rear lower left of unit)
Position of supply
If > 6 ft please advise
Medical electrical equipment needs special precautions regarding EMC and needs to
Electro Magnetic
be installed and put into service according to the EMC information provided in the
Compatibility (EMC)
Appendix

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InnoWaveTM Pro

Water Supply
Water Hardness < 125 ppm with water quality and purity tested and approved for Disinfection as per
(CaCO3), Quality & Purity ANSI/AAMI ST 15883-1:2009 (item 6.4.1 and 6.4.2) or AAMI TIR 34
Pressure 30 – 70 psi for all water supplies
5.3 – 8 gal/m for cold water supply
Flow Rate
3 – 8 gal/m for all other water supplies
Cold Water +41 to 86 °F
Temperature: Hot Water +122 to 140 °F
RO Water + 41 to 140 °F
1x shut valve with ¾ in BSP male thread for hose tail (Hot water)
Connection 1x shut valve with ¾ in BSP male thread for hose tail (Cold water)
1x shut valve with ¾ in BSP male thread for hose tail (RO water)
Position Within 3 ft of proposed installation

Drainage System
Type Gravity
2.125 in. OD outlet from machine
Drain Connection
Drain must be fitted with suitable traps
Drain entry and the entire drain hose must be below the machine drain outlet
Position
Drain pipe inside diameter must be at least 4in
Capacity > 47.5 gal/m
Internally connected within the machine to the drain pipe, downstream of the drain
Overflow
valve
Effluent Temp +203 °F

Compressed Air Supply


Pressure 80 to 100 psi
If medical grade compressed air is not used, an Eliminizer filter needs to be included
Quality
at time of order
Connection 0.315 in. dia. Quick fit hose connector

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InnoWaveTM Pro

2.8 Connecting the InnoWave Pro


Note: STERIS recommends this product be installed & commissioned by STERIS (or suitably qualified
personnel).
1. Unpack the machine and position it within ensuring the castors are aligned front to
3ft of the mains power supply, drain, and back, and apply the front castor brakes
mains water supplies.
2. Identify the drain hose supplied with the
unit. Connect the hose to the drain outlet
underneath the right hand side of the unit.
3. Secure the drain hose to the machine using
the supplied jubilee clip, and cut to length.
Refer to the drain connection diagram in
section 2-10-3 for connection options.
4. Connect the machine drain to the site drain. 15. Fit the front kick plate over the load switch,
ensuring the switch operates. Screw the
5. Connect the compressed air hose to the front kick plate to the machine, and fit the
8mm connector on the lower rear of the rubber hole covers.
unit.
6. Identify the blue cold-water hose supplied
with the unit. Ensure the seal in the hose
end is in place and screw the elbow
connector onto the cold-water inlet at the
lower rear of the unit.
7. Connect the straight end of the hose to a
suitable cold water supply.
8. Identify a stainless steel water hose
supplied with the unit. Ensure the seal in the
hose end is in place and screw the elbow
connector onto the cold-water inlet at the
lower rear of the unit.
9. Connect the straight end of the hose to a
suitable hot water supply.
10. Repeat for the RO water if this has been
made available on site.
11. Turn on the water supplies and check for
leaks.
12. Fit the shorter of the kick plates to the 16. Connect the machine to the electrical mains
machines side, ensuring the nut insert supply (see section 2-7)
faces the front of the machine. 17. Apply power to the machine and open the
lid (see section 3-7-5)
18. Fit the tank filter ensuring it is inserted flat
into the tank recess.

13. Screw the side kick plates to the machine,


and fit the rubber hole covers.

19. Check carrier lift, emergency stop and


safety edge operation (see section 3-7-9)
20. Carry out the commissioning procedure
defined within the InnoWave Pro Service
Manual.
14. Move the machine into its final position,

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2.9 Installation Checklist

Parts one and two must be completed by the technician commissioning the InnoWave Pro for warranty
registration purposes. Where no value is required write pass or fail with a comment if necessary.

Part 1, Test Type Acceptable Value Result Comments

Drains remove effluent effectively -

Phase sequence, Pump Rotation -

Support bases secure -

There is no evidence of
interference to or from other
-
equipment connected to the
same services

Emergency stop operates and -


halts carrier lifting system

For all 5 sections test Safety


Edge activation during downward -
motion halts lifting system then
raises up by approximately 1in

For one side test Safety Edge


activation during upward motion
halts the lifting system

Test Through beam sensor


basket obstruction along machine
front edge during downward
motion halts lifting system then
raises up by approximately 1in

Test Through beam sensor


basket obstruction along machine
front edge during upward motion
halts lifting system

Compressed Air 80 - 100 psi

Hot Water Hardness < 125 ppm

Cold Water Hardness < 125 ppm

122°F min
Hot Water Temperature
176°F max

41°F min
Cold Water Temperature
86°F max

Hot Water Pressure 30 – 70 psi

Cold Water Pressure 30 - 70 psi

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InnoWaveTM Pro

Part 2, Final rinse water Acceptable Value Result Comments

Cold, Hot, RO, DI,


Rinse water supply Type
Softened

If softened, Hardness < 125 ppm

Water Pressure 30 to 70 psi

+41 °F min.
Temperature
+176 °F max.

< 30 µS/cm (RO)


Electrical conductivity < 10 µS/cm (DI)
< 300 µS/cm (Soft)

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2.10 Installation Drawings


2.10.1 Rear View Showing Services

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2.10.2 Front View

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InnoWaveTM Pro

2.10.3 Left Side View with Lid Closed showing Drain Connection

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2.10.4 Left Side View Lid Open

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BLANK PAGE

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3. Operation

3 Operation
User Manual

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InnoWaveTM Pro

3.1 Menu
The InnoWave Pro is controlled using a touch screen menu. The scroll arrows are used to cycle
through the menu pages.

Menu Functions
Start the automated cycle
Start
sequence

Set the selected wash


Wash Program
program

Chemical 1 Prime chemical pump 1

Chemical 2 Prime chemical pump 2

Clock Set the time and date

Download logged cycle data


Data Logging
onto a USB Flash Drive

View and Edit Program


Supervisor Menu
Parameters

Serial number, cycle count


Information
and software version

Controls to raise and lower the


Carrier
Carrier Lift

Note: When the InnoWave Pro has been idle for 10 minutes the screensaver will start, touch the display
to exit.

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3.2 Power Up
Turn on the power to the machine using the Before the carrier lift system can be used, it
isolation switch on the wall. must zero its position sensor. If the machine
was powered off and the carrier lift was not fully
When the machine is turned on, it conducts a
open or closed, then the display will show:
Power-On Self-Test (POST) to ensure the
machine is ready for use.
This process takes a few seconds to configure
the machine and check the basic operation of
the control system, memory and sensor
interfaces.

Press and hold until the carrier lift is fully


open.

3.3 Authorization code


This is an optional feature, which can be
enabled by a service technician. When
enabled, the user is required to enter a four-digit
PIN number to unlock the user control panel. A
valid PIN entry identifies the user and their
operator number is shown on the data export.
There are 80 operator numbers each with a
unique PIN number, see Appendix 6-7 for
details.

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3.4 Setting Time & Date
The time and date must be set correctly to ensure the accuracy of the cycle records, and MUST be
periodically checked by the user. There is no automatic provision for daylight saving hours. While the
machine is off, a backup battery maintains the time and date.

3.4.1 Set Time 3.4.2 Set Date


1. Use the scroll arrows to cycle 1. Use the scroll arrows to cycle
through to the clock icon through to the clock icon

2. Press Set Time 2. Press Set Date


3. Use the arrows to adjust the 3. Use the arrows to adjust the
Hours, Minutes and Seconds Date, Month and Year

4. Press to return to the main menu 4. Press to return to the main menu

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InnoWaveTM Pro

3.5 Selecting a program

The InnoWave Pro is installed with three pre-programmed wash cycles, and three customizable open
programs. When starting a cycle, the machine will use the currently selected program. To change the
selected program, prior to initiating a cycle:

1. Use the scroll arrows to cycle


through to the Wash program icon

2. Change the selected program with the


+ and – buttons

3.5.1 Standard Program Parameters

Supervisor Menu Limits Program Number

P1 P2 P3 P4 P5 P6

Standard Disinfect Cycle

Standard Wash Cycle

Decontamination
Parameters Units

Open

Open

Open
Pre-wash Time Minutes 0 20 5 0 0 0 0 5

Degas Minutes 0 10 3 2 0 0 0 3

Wash Time Minutes 0 40 12 8 0 0 0 12

Rinse 1 Time Minutes 0 20 2 0 0 0 0 2

Rinse 2 Time Minutes 0 20 2 0 0 0 0 2

Disinfection Time Minutes 0 20 3 0 0 0 0 3

Drying Time Minutes 0 30 1 1 0 0 0 1

Typical Cycle -
Minutes - 28 11 0 0 0 28
Time*

*Not including filling, heating, cooling and draining time

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InnoWaveTM Pro
3.6 Chemical Handling
Users must read this section prior to any chemical handling.
• Detergents are caustic and can cause adverse effects to exposed tissues. Do not get in
eyes, on skin or attempt to ingest by mouth
Warning • Read and follow precautions and instructions on detergent label and in the Safety Data
Sheet (SDS) and Instructions for Use (IFU) prior to handling chemical, or servicing chemical
injection pumps and lines
• Wear appropriate Personal Protective Equipment (PPE) whenever handling chemicals or
servicing chemical injection pumps and lines. This should include plastic gloves, goggles or
full-face visor, and disposable plastic apron
• Wear appropriate PPE whenever removing baskets or parts from cleaning chamber
• In case of body contact with chemical, always follow emergency procedure given in that
chemical’s SDS or call emergency services
• Guidelines to be followed in case of emergency caused by chemical contact should be
prominently displayed near the machine
• Other chemistries have to be validated and proven compatible with the InnoWave Pro

3.6.1 Chemistry Sensing 3.6.3 Disposal of chemical containers


The machine weighs the chemical to detect For the correct disposal of chemical containers,
when there is insufficient chemical to run a please refer to the manufacturer’s instructions
cycle, prompting the user to replace the bottle and local regulations.
before the cycle begins.
3.6.4 Chemical Priming
3.6.2 Chemical Replacement When changing an empty detergent bottle, to
The two center doors allow access to the prevent unnecessary cycle errors the system
chemical storage compartment, where the should be primed to ensure chemical fills the
pickup connections are located. The pickup entire hose, from the supply to the tank.
tube for chemistry 1 is on the left, and chemistry
2 is on the right. 1. Remove the empty container
2. Place the new container in the tray
3. Check intake hose filter is clear of
debris
4. Place the intake hose in the container,
ensure any spillages are cleaned up
5. Use the scroll arrows to cycle
through to the relevant Prime Chemical
Pump icon or

Chemical bottles must be connected to


the correct port. Otherwise, wash 6. Press Prime Chem. Pump to start the
efficiency and/or rinsing will be chemical pump
compromised. Ensure that the chemical
Caution type matches the port shown on the 7. When chemical can be seen entering
display. the tank, press Prime Chem. Pump
again to stop the pump

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InnoWaveTM Pro
3.7 Baskets 3.7.2 Basket Insertion
The InnoWave Pro has three baskets, which To insert the basket, place it on the white guide
are used to house DIN baskets. Easily placed rails and push it back
into and removed from the machine, the
baskets are held in racks on three levels and
dock onto water supply spigots at the rear of the
rack. To prevent the baskets from moving
during operation they are locked into position
with securing flags.

3.7.1 Basket Removal


To remove the basket, push the ball up on both
sides of the rack. The flags will drop down
allowing the basket to be pulled out of the rack.

ENSURE the basket docks onto the irrigation


spigots

Carefully pull the basket away from the


machine.

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InnoWaveTM Pro
Push up the locking flags 3.7.3 Instruments
Each basket is equipped with twenty lumened
connections.
When selecting Instruments for the InnoWave
Pro:
• Always confirm compatibility with the
instrument manufacturer.
• Always follow the manufacturer’s
instructions if processing instruments
with special characteristics e.g. fiber
optics or rigid optics.
• Whether pre or post processing
instruments, Always follow the
manufacturer’s instructions.

3.7.4 Instrument Loading Precautions


When loading instruments into a basket
observe the following precautions:
• Do not place items directly into the
wash tank or allow them to make
contact with the tank sides
• Do not load basket with instruments
pointing at the lid
ENSURE the ball latches in the down position • Do not overload the basket, maximum
before moving the carrier lift load of 22 lbs per basket
• Do not allow Luer pipes to protrude
from the basket
• Always use a Full DIN Tray Standard
to hold instruments (M20044)
• Always attach tubing to a suitable size
distal connector for instruments being
cleaned or to a quick connect port if the
instrument has one
• Always open box jointed instruments
• Always ensure taps are open on
cannulated instruments
• Always disassemble instruments that
are designed to be taken apart

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InnoWaveTM Pro
3.7.5 Carrier Lift Controls 3.7.7 Safety Edge
Use the scroll arrows to cycle through to To protect the operator from injury a Safety
the carrier icon. Edge pressure activated strip circles the tank
perimeter.

Press and hold to index the carrier lift up to


the next level
If the safety edge is pressed, the carrier lift will
Press and hold to index the carrier lift down stop and a message will be displayed:
to the next level
Press and hold to open the carrier lift without
stopping at each level
Press and hold to close the carrier lift without
stopping at each level

Pinch points are created during lid


articulation. Keep hands clear
when opening or closing the lid.

3.7.6 Light Guard To allow the Carrier Lift to be operated again,


To protect against accidental damage of the remove the obstruction and press Reset Safety
Baskets and Lifting system, a light beam sensor Edge on the display.
monitors for obstruction along the front of the
Carrier Lift. If this beam is broken (i.e. by
instruments, carriers or carrier flags) the carrier 3.7.8 Emergency Stop
lift will stop and a message will be displayed: In the unlikely event of an
uncontrolled fault, the emergency
stop button can be pushed to cut
power to the Carrier Lift and other
critical outputs.

Note: If the Carrier Lift was travelling down


when a fault is detected, to release an
obstruction it will stop, reverse, travel up about
an inch and stop.
Once the obstruction is removed from the light When the emergency stop is pressed, the
guard path, the machine will allow the Carrier machine will display an error message and
Lift to be operated again. abort a cycle if one was running (see section 3-
9-10). Normal operation can only be resumed
once the emergency stop button has been
pulled out.

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3.7.9 Testing Operation of the Safety Devices

To check operation of the carrier lift: To check operation of the safety edge:

1. Press and hold to fully open the 1. While moving the carrier press the
carrier lift and confirm the display safety edge and confirm the carrier lift
shows: stops and the display shows:

2. Press and hold to fully close the 2. Press Reset Safety Edge on the
carrier lift and confirm the display display and confirm the carrier lift can
shows: be moved again.

To check operation of the emergency stop:

1. While moving the carrier lift press the


emergency stop and confirm the carrier
lift stops and the display shows:

3. If the carrier lift system encounters a


problem it will be shown on the
display:

2. Pull out the emergency stop button


then press OK on the display, and
confirm the carrier lift can be moved
again.

4. If a carrier limit fault message is


shown please contact STERIS to
resolve the fault.

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InnoWaveTM Pro

3.8 Starting a Cycle


The load sequence is optimized for hands free Replace chemical(s) (see section 3-6-
operation using the Load foot pedal to step
2) and press OK to continue, or press
through an automated sequence:
Cancel to abort the cycle start
3. Insert the bottom basket into machine
1. Confirm program selection (to change
and latch (see section 3-7-2)
see section 3-5)

Pinch points are created during lid


articulation. Keep hands clear
when opening or closing the lid.

2. Press and hold the Load foot pedal


until the carrier lift is fully open

4. Press and hold the Load foot pedal


until the carrier lift indexes down to the
next level and stops
5. Insert the middle basket into machine
and latch (see section 3-7-2)
6. Press and hold the Load foot pedal
until the carrier lift indexes down to the
next level and stops
7. Insert the top basket into machine and
latch (see section 3-7-2)
8. Press and hold the Load foot pedal
until the carrier lift is closed, and the
If there is insufficient chemical to cycle will start
complete the cycle a warning will be
shown: Note: the touch screen controls may be used to
open/close and bypass the automated
sequence (see section 3-7-5)

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InnoWaveTM Pro

3.9 Automated Wash Cycle


The automated wash cycle consists of the stages Pre-wash, Wash, Rinse, Final Rinse/Disinfection,
Cooling and Drying. Every stage of the cycle is configured by the Program Parameters stored in the
machines memory (see section 3-5-1). These parameters allow the cycle to be customized to select the
fill water type, skip stages, repeat stages, control temperature set points, set stage duration etc.

During a cycle, the remaining time for each stage will be shown on the right hand side of the display,
and the temperature/pump pressure on the left.

3.9.1 Cycle Process

• Lock Lid The lid is sealed shut to prevent entry during the cycle
Start Cycle

• Fill Fill tank with cold water to the minimum level


• Cycling For a set period alternate between spray arms (45s) and lumen flushing (15s), heating up to 95°F
• Drain Drain until tank is empty, then for a further 20s
Pre-wash

• Fill Fill tank with cold and hot water mix up to the top level
• Dose Detergent is added once the minimum tank level is reached
• Heat Heat water to the set point, circulating through the lumens and spray arms
• Degas Pulse ultrasonics on and off for the degas period, with no recirculation
Wash • Cycling Alternate between ultrasonics (45s) and lumen flushing (15s) for a set period
• Drain Drain until the tank is empty, then for a further 20s

• Fill Fill tank with Hot water upto the minimum level
• Cycling For a set period alternate between spray arms (45s) &lumen flushing (15s), heating up to the set point
• Drain Drain until the tank is empty, then for a further 20s
Rinse

• Fill Fill tank with Hot/RO water upto the minimum level
• Heat Heat water to the set point, circulating through the lumens and spray arms
Final Rinse / • Cycling For a set period circulate through the lumens and lid spray
• Drain Drain until the tank is empty, then for a further 20s
Disinfection

• Fill Add cold or RO water run down the back of the tank up to the bottom level
• Drain Continuously drain the tank throughout
• Repeat Repeat the cooling process until chamber temperature below 140°F
Cooling • Drain Drain until the tank is empty, then for a further 20s

• Soft-shot For a set period compressed air is alternately blown through the irrigation ports and spray arms
Drying

Cycle • Confirm Acknowledge cycle complete by pressing unload on the display


Complete

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InnoWaveTM Pro
3.9.2 Pre-wash 3.9.3 Wash
All water in the tank is drained. The machine fills The tank is filled to the top level with a mix of
with cold water to the minimum level. During hot and cold water to attain the set temperature.
filling for each stage, the spray and irrigation Once the water reaches the mid-level, a
valves are opened, and the pump is operated at quantity of detergent is dispensed into the tank.
least once to ensure all voids are filled. The pump is pulsed on and off to even out the
temperature, fill all cavities, and to mix the
chemical thoroughly.

The machine then washes for a set time,


alternating between spraying and flushing. Once the tank is full, if the temperature is below
the set point, the water heater will turn on.

When the set temperature is reached, the


During flushing recirculated water is pumped ultrasonics degas the tank by pulsing on and off
through the instruments. for a pre-defined time to remove any dissolved
air.

Finally, all water in the tank is drained. At the end of the degas period the machine will
then alternate between irrigation and
Ultrasonics for a pre-defined time.

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InnoWaveTM Pro
3.9.5 Final Rinse/Disinfection
The machine fills with hot water (or RO if fitted)
to the minimum level.

Once the tank is filled, the water heater will turn


on to heat the water to the set point.

Finally, all water in the tank is drained.

3.9.4 Rinse
The machine fills with hot water to the minimum
level.
When the set point is reached, the machine will
alternate between Flushing and Spraying for a
pre-defined time.

The machine will alternate between Flushing


and Spraying for a pre-defined time while
heating the water up to the temperature set
point.

Finally, all water in the tank is drained.

Finally, all water in the tank is drained.

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3.9.6 Cooling 3.9.9 Unload
On completion of the last cleaning stage, the The unload sequence is optimized for hands
inside of the machine will be hot. To reduce the free operation, where the Load foot pedal is
water vapor and temperature, cold water is used to step through an automated sequence:
cascaded down the back wall of the tank and
into the drain a pre-defined time.
1. Press and hold the Load foot pedal
until the carrier lift indexes up to the
bottom basket and stops

Note: this water does not come into contact


with the load.

Finally, all water in the tank is drained.

3.9.7 Drying
To aid the drying of cannulated instruments and
to remove excess water from manifolds and
pipework, compressed air is alternately blown
through the irrigation ports and spray arms. 2. Remove the top basket from the
This minimizes spillage when the baskets are machine (see section 3-7-1)
removed from the machine.
3. Press and hold the Load foot pedal
until the carrier lift indexes up to the
next level and stops
4. Remove the middle basket from the
machine (see section 3-7-1)
5. Press and hold the Load foot pedal
until the carrier lift indexes up to the
next level and stops
6. Remove the bottom basket from the
machine (see section 3-7-1)
3.9.8 Cycle Complete
If any instruments became
When the cycle is complete, a sound is played detached from the STERIS
and the LED Edge flashes green. connection tubing during
processing, they should be
Caution reprocessed ensuring that the
Luer connection is firmly seated.

7. The machine is now ready for the next


cycle

Note: the touch screen controls may be used to


bypass the automated sequence (see section
3-7-5)
Confirm cycle record is present and indicates
the cycle has completed with no errors.

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3.9.10 Re-Wash Cycle Press Reload Complete on the screen to begin
The InnoWave Pro can be configured with a re- another wash stage
wash program - a water and time saving
feature. This allows the wash water and
chemical to be reused. At the end of the wash,
the user is allowed to open the lid, add new
instruments, and repeat the wash stage using
the same water up to ten times.
Note: if the water temperature exceeds the set
point by more than 18 °F the cycle will be
aborted (see section 3-9-10).

At the end of a wash stage press Yes on the


screen to reuse the water again.
To end the re-wash process, once the wash
stage is complete press No on the screen to
drain the water and end the cycle.

Unload the instruments (see section 3-9-9) then


load more instruments for cleaning (see section
3-8).

Temperature of the water within the


unit can reach +140 °F. When
opening the lid and reloading
instruments take care and wear
appropriate PPE.

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3.10 Cycle Errors 3.11 Aborting a Cycle


If an unexpected condition occurs during a While running a cycle in the InnoWave Pro, it
wash cycle (i.e. low pump pressure, low water may be necessary to end (abort) the cycle
temperature, see section 4-1 for a full list) the operation before scheduled completion,
system will abort the cycle and report an error. because of a unit problem, wrong load, etc.

When an error occurs during a cycle To abort a cycle press in the top left corner.
the load may still be contaminated, This will pause the cycle, press Abort to
and will still require re-processing. If confirm or press Resume to continue the cycle.
the error persists use another
machine or alternative cleaning and
disinfection process (according to
facility procedure), then contact a
service technician to repair the
machine.

If an error occurs:
• An audible alarm will sound
• The LED Edge will flash red (see
section 3-12)
• An error code and description will be If the cycle is aborted, a cycle error will be
shown on the display: generated (see section 3-9-10)

• The data log will record the Error


code, description, and diagnostic
information 3.12 LED Edge
The LED Edge color status indicator on the lid
Acknowledge the error by pressing OK. visually shows the current state of the machine:

If the tank is not empty, the water will be Panning Resetting


automatically drained to allow access to the Blue Static Idle
load.
Pulsing Cycle Running
Flashing Cycle End
Green
Static Cycle Completed
Flashing Cycle Halted
Red Static Error
Panning Carrier Lift Moving
Flashing Attention
Orange
Required
Once the tank is drained, the machine will be
reset and return to the main menu.

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3.13 Downloading the Cycle Log
The InnoWave Pro contains on board memory, which holds up to 10,000 cycles. This Log can be
downloaded to a USB flash drive via the USB Data port located in the chemical cabinet on the left hand
side.

3.13.1 Download Logs


1. Use the scroll arrows to cycle
through to the log icon

5. Once the log files have been


downloaded remove the USB drive and
press OK

2. Insert the USB flash drive into the USB


data port.
Note: the flash drive must be formatted
as FAT32.
3. Press All Logs to download all cycle
logs, or New Logs to download the
cycle logs since the last download.
4. Wait for the logs to be downloaded to
6. A file for each cycle will be stored in the
the USB drive. Do not remove the USB
USB drive directory:
Drive while downloading, as this could
STERIS\<machine serial number>\<cycle
corrupt its contents.
range>\<cycle number>.txt

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InnoWaveTM Pro

3.14 Supervisor Menu 4. Enter the Program Name via the touch
The supervisor menu allows for viewing of the screen keyboard
program parameters and customization of
Open programs.

3.14.1 Open the Supervisor Menu:


1. Use the scroll arrows to cycle
through to the cog icon

5. Set the Pre-wash Stage Time and


Repetitions using the buttons

2. Press Supervisor Menu


3. Enter the six-digit PIN number
(default is 123456)

6. Set the Wash Stage water level depth


for ultrasonic cleaning using the
buttons

3.14.2 Program Editor/Viewer


1. Use the scroll arrows to cycle
through to the program to be viewed or
edited

7. Set the Ultrasonic degas time for the


Wash Stage using the buttons

2. Press Edit Program


3. Use the scroll arrows to cycle
through the different program
parameters for each Stage of the cycle. 8. Set the Wash Stage minimum required
Note: If the program is locked the irrigation pressure using the
modify controls are not shown buttons
For standard instruments 0psi

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9. Set the Wash Stage Detergent 13. Set the Drying Stage Time using the
Quantity, Temperature and Time using
buttons
the buttons

14. Use the scroll arrows to


10. Set the number of Rewashes using
navigate to the Save Changes page.
the buttons Press OK to commit the changes to
memory, or press Cancel to discard
the changes.

11. Set the Rinse Stage Temperature,


Time and Repetitions using the
buttons 15. The machine will now return to the
Supervisor Menu

12. Set the Disinfection Stage Lubricant


Quantity, Temperature and Time using
the buttons

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3.14.3 Change PIN Code
1. Use the scroll arrows to cycle
through to this page:

2. Press Enter New Pin


3. Enter a new six-digit PIN

4. Enter the new PIN again to confirm

3.14.4 Exit the Supervisor Menu


To exit the supervisor menu press the
button.

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3.15 Routine Maintenance

Important safety information:


Always ensure mains power is disconnected.
Always adhere to the recommended safety precautions for cleaning products in use.

It is recommended that Personal Protection Equipment (PPE) be worn during loading/unloading, and
cleaning or decontaminating the equipment. This must include apron, gloves and eye-protection.

For cleaning internal and external surfaces use an EPA registered disinfectant cleaner.

In the interests of health and safety, all medical Sonic Irrigators should be cleaned on a weekly basis
as part of a routine maintenance program. This will ensure the machine is safe for operators and
maintenance personnel. To keep your machine operating within its design parameters the following
checks must be performed on a regular basis. Please note that completion of these checks is not a
substitute for regular servicing and maintenance by a suitably qualified technician.

All maintenance procedures should be carried out in a well-lit environment, recommended minimum
lighting level is 500 Lux.

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3.15.1 Before Every Cycle
1. Visually check that there is enough chemical for the next wash. Replenish as necessary.
2. Clean the wash tank filter:

Ensure the tank filter is correctly replaced such that it is inserted flat into the recess.
3. Check the wash chamber is free from any debris or deposits
4. Check the spray arms rotate
5. Remove each basket and check the spray arms for blockage:

Remove the spray arm by first rotating counter clockwise and then pull

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InnoWaveTM Pro

Check inside the spray arm and clear


any debris
3.15.2 Daily Checks

1. Check that there is sufficient chemical


for the day’s planned use
2. Check and clean all internal surfaces
above the water line
3. Check and clean all external surfaces
To ensure correct spray direction the including lid seal
spray arms are designed so they 4. Check mains power cord is not
cannot be inserted incorrectly: trapped, damaged, and the plug is
secure in its socket (if fitted)
5. Mechanical cleaning equipment
performance should be tested each
day it is used, and all results should
be recorded

6. Check lid and lid seal for any damage

If damage is found, please contact a


service technician.
Caution

To replace the spray arm, line up the


slot to the internal hub pin, push in
and then rotate clockwise:

6. Check the condition of basket


irrigation port Luer hoses, ensure they
are not kinked or ruptured.

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7. Check the 4 lid docking seals for any 3.15.3 Weekly checks
damage
1. Carry out the daily checks
2. Check condition of mains water
supply hoses
3. Visually inspect water and drainage
system for leaks
4. Run a full decontamination
procedure (see section 3-16)

If damage is found, please 5. Test operation of safety devices (see


contact a service technician section 3-7-9)
Caution

8. Check the six basket docking seals for


any damage or debris

If damage is found, please


contact a service technician.
Caution

9. Check the six basket manifolds for


blockage

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3.16 Decontamination Guide


Decontamination is defined as the cleaning and disinfection of the machine to remove biological and
chemical dangerous substances and is vital to ensure the machine is safe for operators and
maintenance personnel.
Important safety information: 3.16.2 Full Decontamination
• Always ensure mains power is On a weekly basis:
disconnected when manually 1. Perform the daily cleaning procedure
decontaminating.
2. Fit luers to all basket port to ensure
• Always adhere to the recommended they are open
safety precautions for cleaning
products in use. 3. Run Program 6 (see section 3-5 and 3-
8)
• Always work in a well-lit area,
recommended minimum lighting If the machine has been idle for more than a
level is 500 Lux. week:
• It is recommended that Personal 1. Perform the daily cleaning procedure
Protection Equipment (PPE) be 2. Fit luers to all basket port to ensure
worn during loading/unloading, and they are open
cleaning or decontaminating the
equipment. This must include 3. To make a 5% disinfectant solution
apron, gloves and eye-protection. place 0.5 gallon (typically) of non-
foaming Sodium Hypochlorite based
For cleaning internal and external surfaces, a disinfectant into a shallow heat
disinfectant cleaner such as Isopropyl Alcohol resistant container. Place the container
or a household kitchen cleaner can be used, in the basket (this prevents it from
provided it is marked as a DISINFECTANT being drained at the start of the cycle)
cleaner.
4. Select Program 6 (see section 3-5)
5. Start the cycle (see section 3-8)
3.16.1 Daily Cleaning/Procedure
6. 30 seconds before the Pre-wash stage
Using a clean cloth or paper towel:
finishes, press to pause the cycle
1. Wipe down all internal surfaces 7. Wait 15 minutes then press Resume to
above the waterline with your continue the cycle
disinfectant, including the inside of the 8. Allow the cycle to complete
lid and around the seals 3.16.3 Pre-Transport Procedure
2. Wipe all external surfaces, including In the unlikely event of a machine having to be
around the sides of the doors returned to STERIS for any reason, the
following procedure must be carried out:
3. Remove any trace of cleaner from
1. Drained and completely empty of fluid
internal and external surfaces with a
clean wet cloth 2. All external hoses removed
4. Towel dry 3. Fully decontaminated prior to
shipping (see Section 3-16-2),
Note: By the nature of its operation, the (irrespective of when it was last
InnoWave Pro tank is immersed during the cleaned)
cleaning/disinfection cycle. Therefore, it should 4. Accompanied by the relevant signed
already be clean and disinfected by the end of
a cycle. Decontamination Certificate (see
section 3-16-4)
Note: If due to the nature of any fault present,
the unit cannot be run prior to return, the Failure to carry out this procedure may
tank/chamber must be decontaminated by
cause harm to personnel in contact with
hand.
the machine and will incur an additional
charge for a full decontamination.

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3.16.4 Decontamination Certificate


Ensure that all items returned to your supplier are disinfected in accordance with the appropriate
hospital procedure for equipment of this type.

When returning this product to your supplier, the form must be completed and attached to the outside
of the crate/carton. If it is not visible, the courier and/or your supplier can refuse to handle this product.

DECONTAMINATION CERTIFICATE

Promoting a Clean and Safe Service

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4. Troubleshooting

4 Troubleshooting
User Manual

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InnoWaveTM Pro

This section of the manual describes the types of InnoWave Pro problems which may occur, and
indicates probable causes/corrections.

If the situation cannot be corrected following the Troubleshooting Solutions, repeating the cycle, or if a
problem occurs which is not described, then please contact STERIS. Service charges may be incurred,
consult your warranty for details. A trained service technician will promptly place your InnoWave Pro in
proper working order.

NOTE: Never permit unqualified persons to service the system. If a system problem cannot be corrected
using this section, please contact STERIS.

Calling for Service: First, try to define the situation and determine whether it can be solved (see section
4-1 and 4-2). If the situation cannot be solved, call STERIS and provide the following information:

• A description of the fault


• Model number
• Serial number
• A copy of the printout showing the error

4.1 Error Messages

Error
Error Message Possible Causes and Solutions
Code

1 Mains Power Removed Check mains supply to unit was not interrupted during a cycle

2 Switch the machine off then on again, if the problem persists turn the
Chamber Overflow
machine and the water supply off and call a service technician

3 Check tank filter clear, ensure drain is not blocked


Drain Timeout
Check that a non-foaming chemical is being used

4 Chamber Temperature
Repeat cycle
Sensor Mismatch

5 Check water supply(s) to the machine are switched on


Chamber Fill Timeout
Check water inlet hose(s) for kinks

6 Chamber Opened Check lid is closed

7 Temperature Set Point Not


Repeat cycle, if the problem persists call a service technician
Maintained

10 Check that a non-foaming detergent is being used


Chamber Water Level Low
Check for leaks

Repeat cycle
11 Chamber Water Heat Rate
Temperature sensor or water heater element failure, please call a
Low
service technician.

13 Check chemical bottle level(s) and replace if required. Check chemical


Chemical Dosing
pickup tube is inserted into the chemical container

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Error
Error Message Possible Causes and Solutions
Code
Check the Cold water temperature is not above 95°F
14 Chamber Start Temperature
too High The chamber has not cooled sufficiently since the last wash.
Leave more time between washes for the machine to cool down.

15 Chamber Temperature Out of


Switch the machine off then on again
Range
16 17
18 19 Level Sensor Invalid Repeat cycle
51
20 User Aborted Cycle Repeat cycle
Check tank filter is clear/clean
Check Baskets are docked properly
21 Low Main Pump Pressure Check basket ports are not blocked
Check basket docking seals clean
Check for leaks
Check Baskets are docked properly
22 Check basket ports are not blocked
High Main Pump Pressure
Check basket docking seals clean
Check for leaks

23 Temperature Set Point


Repeat cycle
Exceeded

38 Compressed Air Absent or


Check compressed air to the machine is turned on
Pressure Low
39 40
41 43
Sonic Generator Fault Switch the machine off then on again
45 46
47
Check water supply flow rate is sufficient
42 Maximum Cycle Time Expired Check tank filter clear, ensure drain is not blocked
Repeat cycle
44 Sonic Cleaning Water Level
Check for visual leaks
Low

48 Determine reason why emergency stop was pressed before pulling the
Emergency Stop Pressed
button to release
49 57
Microcontroller Error Switch the machine off then on again
58

Switch the machine off then check for blockages in the ventilation
50 Internal Ambient Temperature
holes
too High
Switch the machine on again after an hour

52 Real Time Clock Read Error Switch the machine off then on again

53 24V Power Supply Voltage


Switch the machine off then on again
Out of Range

54 Overfill occurred during cool Check tank filter clear, ensure drain is not blocked
down process Repeat cycle
Check tank filter is clear/clean
Check Baskets are docked properly
56 Low Wash Irrigation Pressure Check basket ports are not blocked
Check basket docking seals clean
Check for leaks
59 Unable to Store Cycle Log Repeat cycle

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InnoWaveTM Pro

4.2 Other Faults

Problem Possible Causes and solutions


• Insufficient detergent injected - Contact STERIS
• Check that a recommended chemical is being used
Poor Load Cleaning • Instrument basket is overloaded - Adjust load
• Instruments are excessively soiled
• Instruments have been left soiled for more than two hours
• Verify facility power meets Unit specifications

• Check instruments are lying flat in the basket and not


Water Leaking from Lid pointing up at the lid, adjust the load
Area
• Check lid seal is undamaged

• Check incoming water pressure is above 29 psi


Excessive Fill Time • Check water inlet valve is not blocked (beware of hot water
temperature!)

• Check all connectors are fully inserted


• Clean tank filter
Low Irrigation Port Flow
• Check basket manifold ports are not blocked
Rate
• Check tank docked ports are not blocked
• Verify facility power meets Unit specifications

• Installation Main disconnect switch is in the OFF position


Turn main disconnect switch to the ON position
No Power to Unit or
• Facility power is incorrect for unit. Correct facility power to
Display is off
meet unit requirements
• Internal Circuit breaker has tripped, contact STERIS

Access to the load in the • The InnoWave Pro contains a manual override to allow the
event of a power failure or lid to be opened, this must be carried out by trained service
stuck lid mechanism personnel. Please contact STERIS.

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5. Technical

5 Technical
User Manual

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5.1 General Specifications

General
Description Healthcare ultrasonic Sonic Irrigator
Internal and external cleaning and thermal disinfection of surgical instruments,
Intended Purpose
hollow-ware, and associated products
Ultrasonic activity, Spray Arms, Irrigation Ports and heating for thermal
Operating Process
disinfection
Class 1 electric shock protection, externally powered
No applied parts
Classifications IP rating – IPX0 (refer to BS EN 60601-1, para 6.3)
Not suitable for use in an oxygen rich environment
Mode of operation – intended for continuous use

User Interface
Display TFT Touch Screen
Used for hands free operation of carrier lifting system and cycle start and
Foot Switch
unload.
Lid Edge Multi Color LEDs for visual indication of machine status
Lighting
Blue LED Loading Illumination

Baskets
Quantity 3 Baskets per machine
Two 10-way manifolds per standard basket, one on each end
With ten ports open each manifold outputs produces up to:
Features 43.5 psi pressure with a flow rate of 100 US fl.oz/min.
2 Spray arms per Basket
Soft-shot – Compressed air irrigation and spray arm water
Full DIN Tray Standard to hold instruments (M20044) –
Din Basket Compatibility
Length 19 in. Width 10in Height 3 in.
Tray Compatibility size Length 25.9 in. Width 13.5in Height 3.1 in.
Interior dimensions Length 26.3 in. Width 13.6in Height 3.7 in.
Max Load Weight 22 lb per basket (total 66 lb)

Carrier Lift
Electrically actuated carrier lift
Features Guided slide lock system, with retaining flag
Safety Edge strip and light beam for obstruction detection

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InnoWaveTM Pro
Ultrasonics
Frequency 38 to 40 kHz dependent on load
Transducers 84 piezo ceramic
Power 3 kW
Pulsed Degas
Features Auto-tune
Frequency Sweep

Electrical Supply
Mains supply voltage fluctuations up to ±10% of the nominal voltage;
Transient over voltages typically present on the mains supply (Overvoltage
General
Category II).
Pollution Degree 2
Voltage: 200 to 230 Vac 3P+PE (Three Phase + Protective Earth)
Frequency: 60 Hz
Power: 18 kW
IWPRO60
Site Current Capacity: ≥ 48 A per phase
Site MCB and Disconnect Switch Current Rating: 63 A
Site Wiring Cross-sectional area: 10 mm2

Water Supply
Back Siphonage Protection Integral AB type air gap and weir observing BS EN 1717
Per cycle stage:
• Pre-wash 10.5 gal
• Wash 66 gal
• Rinse 10.5 gal
• Disinfection 10.5 gal
• Disinfection Condensate 43.5 gal
• Cooling 28 gal
Consumption
(approximate)
Total Per supply:
• Cold 76 gal
• Hot 65 gal
• RO 38 gal

Total Cycle 180 gal


Consumption will vary depending on the cycle selected and the site utilities

Drainage System
For installation and assembly information on the Drain Tempering Valve kit refer to the applicable Technical
Bulletin and drawings. These are available in Medicate->Information->Products and on KMS under the
appropriate unit’s troubleshooting folder.
Type Gravity
Drain Connection 2.125 in. OD outlet
Internally connected within the machine to the drain pipe, downstream of the drain
Overflow
valve

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InnoWaveTM Pro
Effluent Temp +203°F

Seismic Kit
For installation and assembly information on the Seismic kit refer to the applicable Technical Bulletin and
drawings. These are available in Medicate->Information->Products and on KMS under the appropriate unit’s
troubleshooting folder.

Dimensions
Wash Chamber Liquid Volume 43.5 gal
Wash Chamber Capacity 59 gal
Width 36.4 in.
Wash Chamber Dimensions Depth 15.2 in.
Height 20.9 in.
Width 49.6 in.
Depth 33.7 in.
Outer Cabinet Dimensions
Height Lid Closed 43.5 in.
Height Lid Open 65 in.
Width 59.5 in.
Shipping Container Dimensions Depth 45.3 in.
Height 59.1 in.

Weight
Operational weight (Dry) 905 lb
Shipping weight 1135 lb

Chemicals
Integral Chemical cupboard for 2 bottles
Storage Max Bottle Size:
Width 9 in. Depth 8 in. Height 12 in.

Environmental conditions
Use Indoor, Altitude up to 6562 ft
Ambient Operating Temperature +41°F to 104°F
Maximum relative humidity 80% for temperatures up to +87.8°F
Humidity
decreasing linearly to 50% relative humidity at +104°F
Noise Max SPL 69dBA @ 6 ft from the front of the machine

Real Time Clock Battery


Type CR1220 (5012LC)
Typical Capacity 35 - 40 mAh
Standard Discharge Current 0.1 mA

Range and Accuracy


Measurement range +36 ºF to 208 ºF
Water Temperature Displayed and printed to the nearest ºF accuracy ±0.9ºF
Max water temperature: +203 ºF (limited by software and thermal trip)

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InnoWaveTM Pro
Time Displayed in minutes and seconds, accuracy ±0.5sec

5.2 Applied Standards

Standard Description

Safety requirements for electrical equipment for measurement,


UL 61010-1:2015
control, and laboratory use.
CAN/CSA-C22.2 Safety requirements for electrical equipment for measurement,
No. 61010-1-12:2015 control, and laboratory use.
Safety requirements for electrical equipment for measurement,
IEC 61010-1:2015
control, and laboratory use.
Particular requirements for sterilizers and washer-disinfectors used
IEC 61010-2-040:2015
to treat medical materials.
Washer-disinfectors - Requirements and tests for washer-
disinfectors employing thermal disinfection for surgical instruments,
ANSI/AAMI ST15883-2:2013(R)2015
anesthetic equipment, bowls, dishes, receivers, utensils,
glassware, etc.
Medical electrical equipment. General requirements for basic safety
IEC 60601-1-6:2010+A1:2015
and essential performance.
Medical electrical equipment. General requirements for basic safety
IEC 60601-1:2006 +A12:2014
and essential performance.
Medical electrical equipment. General requirements for basic safety
IEC 60601-1-2:2007 and essential performance. Collateral Standard. Electromagnetic
disturbances. Requirements and tests.
Medical devices. Application of usability engineering to medical
ANSI/AAMI/IEC 62366-1:2015
devices.
ISO 13485:2012 Medical devices - Quality management systems
Medical devices - Application of risk management to medical
ISO 14971:2012
devices.
PD IEC/TR 60878:2015 Graphical symbols for electrical equipment in medical practice.
Electrical equipment for measurement, control and laboratory use.
EN 61326: 2013
EMC requirements. General requirements.

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6. Appendices

6 Appendices
User Manual

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InnoWaveTM Pro

6.1 EMC

6.1.1 EMC & Electromagnetic Compatibility Data


Instructions/Notes regarding the InnoWave Pro and Electromagnetic compatibility (EMC) testing to
EN60601-1-2:2007.

The InnoWave Pro has been tested regarding its ability to operate in an environment containing other
electrical/electronic equipment (including other medical devices).

The purpose of this testing is to ensure that the InnoWave Pro is not likely to adversely affect the normal
operation of other such equipment and that other such equipment is not likely to adversely affect the
normal operation of the InnoWave Pro.

Despite the testing of the InnoWave Pro that has been undertaken, normal operation can be affected
by other electrical or electronic equipment. Portable and mobile RF communications equipment can
affect medical electrical equipment.

As the InnoWave Pro is medical equipment, special precautions are required regarding EMC.

It is important that the InnoWave Pro is configured and installed/put into service, in accordance with the
instructions/guidance provided herein and is used only in the configuration as supplied.

The InnoWave Pro’s data cable must be restricted to less than 9 feet 10 inches (3 metres) in length
and should not be extended by the user. If the InnoWave Pro is used with adapted cables or cables
other than those supplied, this may result in increased emissions or decreased immunity of the
InnoWave Pro, in relation to EMC performance.

It should be noted that the cables provided with the InnoWave Pro should not be used on other
equipment. To do so may result in increased emissions or decreased immunity of the other equipment
in relation to EMC performance.

The InnoWave Pro should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use with other equipment is necessary, the InnoWave Pro and the other equipment should be
observed / monitored to verify normal operation in the configuration in which it will be used.

For the purposes of EN60601-1-2, the InnoWave Pro has an essential performance as follows:

Functions within the operating cycle should continue to operate as normal, and the product should
complete its operating cycle correctly.

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6.1.2 Electromagnetic Emissions

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions


The InnoWave Pro is intended for use in the electromagnetic environment specified below. The
customer or the user of the InnoWave Pro should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

The InnoWave Pro uses RF energy only for its


RF emissions internal function. Therefore, its RF emissions are
Group 1
CISPR 11 very low and are not likely to cause any
interference in nearby electronic equipment.

RF emissions
Class A
CISPR 11

The InnoWave Pro is suitable for use in all


Harmonic emissions establishments other than domestic and those
Not Applicable
IEC 61000-3-2 directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.

Voltage fluctuations /
flicker emissions Not Applicable
IEC 61000-3-3

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6.1.3 Electromagnetic Immunity

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity


The InnoWave Pro is intended for use in the electromagnetic environment specified below. The customer or the user
of the InnoWave Pro should assure that it is used in such an environment.

Electromagnetic environment
Immunity test IEC 60601 test level Compliance level
- guidance

Floors should be wood,


Electrostatic discharge concrete or ceramic tile. If floors
± 6 kV contact ± 6 kV contact
(ESD) are covered with synthetic
± 8 kV air ± 8 kV air
IEC 61000-4-2 material, the relative humidity
should be at least 30%.

± 2 kV for power supply


Electrical fast transient / ± 2 kV for power supply
lines Mains power quality should be
burst lines
that of a typical commercial or
± 1 kV for input / output
Input / output line tests hospital environment.
IEC 61000-4-4 lines
are not applicable.

± 1 kV differential Mains power quality should be


Surge ± 1 kV line(s) to line(s)
mode that of a typical commercial or
IEC 61000-4-5 ± 2 kV line(s) to earth
± 2 kV common mode hospital environment.

<5% UT Not Applicable


(>95 % dip in UT) For (Rated input current Mains power quality should be
0.5 cycle >16A per phase)
that of a typical commercial or
hospital environment. If the
Voltage dips, short 40% UT Not Applicable
user of the InnoWave Pro
interruptions and voltage (60 % dip in UT) (Rated input current
requires continued operation
variations on power supply for 5 cycles >16A per phase)
during power mains
input lines
interruptions; it is
70 % UT Not Applicable
IEC 61000-4-11 (Rated input current recommended that the
(30 % dip in UT)
>16A per phase) InnoWave Pro be powered from
for 25 cycles
an uninterruptable power
<5% UT <5% UT supply or a battery.
(>95 % dip in UT) (>95 % dip in UT)
For 5 s For 5 s

If incorrect operation occurs, it


may be necessary to position
the InnoWave Pro further from
Power frequency (50/60Hz) sources of power frequency
Magnetic field magnetic fields or to install
3 A/m 3 A/m (50Hz only)
magnetic shielding. The power
IEC 61000-4-8 frequency magnetic field should
be measured in the intended
installation location to assure
that it is sufficiently low.

Note: UT is the A.C. mains voltage prior to application of the test level.

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity


The InnoWave Pro is intended for use in the electromagnetic environment specified below. The customer
or the user of the InnoWave Pro should assure that it is used in such an environment.

IEC 60601 test Compliance


Immunity test Electromagnetic environment - guidance
level level

Portable and mobile RF communications


equipment should be used no closer to any
part of the InnoWave Pro, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance (d)

Conducted RF 3 Vrms 3 Vrms d = 1.2√P


IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80
MHz

Radiated RF 3 V/m 3 V/m d = 1.2√P 80 MHz to 800 MHz


IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 2.5 d = 2.3√P 800 MHz to 2.5 GHz
GHz

Where P is the maximum output power rating of the


transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Fields strengths from fixed RF transmitters, as
determined by an electromagnetic site survey (see
Note a) should be less than the compliance level in
each frequency range (see Note b)
Interference may occur in the vicinity of equipment
marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the InnoWave Pro is used exceeds the
applicable RF compliance level above, the InnoWave Pro should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
InnoWave Pro.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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6.1.4 Separation Distances Between InnoWave Pro and Mobile RF Equipment

Recommended separation distances between


portable and mobile RF communications equipment and the InnoWave Pro

The InnoWave Pro is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the InnoWave Pro can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the InnoWave Pro as recommended below,
according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter


Rated maximum output power m
of transmitter 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W

d = 1.2√P d = 1.2√P d = 2.3√P


0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures objects and people.

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6.2 Warranty and Disclaimers

Seller warrants capital equipment to be free allowing Seller the opportunity to inspect the
from defects in material and workmanship Products, and in the event of repair or
under normal use and operation for a period of replacement, returns the Product to Seller,
one year after date of shipment to Customer. freight prepaid. Defective parts replaced by
Seller’s sole warranty with respect to all other Seller shall become the property of the Seller.
Products is that such products comply with Repaired or replacement parts will be shipped
Seller’s specifications for a period of 90 days to the Customer FOB point of shipment.
from the date of shipment, unless the Product Product that is returned to Seller but that is
is subject to an expiration date, in which case found by Seller to conform to Seller's warranties
the expiration date shall apply. Seller’s shall be returned to Customer at Customer's
warranties do not apply to damage resulting expense and otherwise subject to the
from unauthorized installation, accident, provisions of section IV above.
casualty, alteration, misuse, or failure to follow
Seller’s written instructions. No other express
If the Product sold is not manufactured by
warranty is made with respect to the Products.
Seller, Seller will extend to the Customer the
If any model or sample was shown to Customer,
same warranty protection Seller received from
such model or sample was used merely to
the original manufacturer.
illustrate the general type and quality of the
Products and not to represent that the Products
would necessarily conform to the model or Seller is not responsible for any warranty work,
sample in all respects. ENTIRE WARRANTY: repairs, replacements, or other work, or
SELLER MAKES NO OTHER WARRANTY, charges relating thereto, that have not been
EXPRESS OR IMPLIED, AND SELLER authorized by Seller in writing.
EXPRESSLY DISCLAIMS ANY WARRANTY
OF MERCHANTABILITY OR FITNESS FOR Where applicable and purchased separately,
ANY PARTICULAR PURPOSE, AND ALL Seller agrees to delay the start date of the
OTHER WARRANTIES ARE HEREBY warranty for up to 12 months from the date of
EXPRESSLY EXCLUDED. SELLER SHALL shipment, provided Seller confirms by
HAVE NO OTHER LIABILITY, DIRECT OR inspection that as of the deferred start date, the
INDIRECT, OF ANY KIND, INCLUDING Products meet Seller's original factory
LIABILITY FOR SPECIAL, INCIDENTAL, OR specifications and do not materially differ from
CONSEQUENTIAL DAMAGES. their factory-shipped condition.

Customer agrees that its sole and exclusive


remedy for breach of the foregoing warranties
shall be the repair or replacement and
reinstallation of defective parts (with the
exception of items normally considered to be
expendable such as filters, fuses, gaskets,
lamps, printer paper, printer ribbons, ink,
lubricants, charts, etc.), or, at the Seller’s
option, to refund the purchase price; provided
(1) the Product has not been altered or modified
by other than Seller, (2) it has been properly
stored, installed, maintained and operated
within the limits specified by Seller, and (3)
Customer promptly sends to Seller notice of
defect and satisfactory proof thereof, including

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InnoWaveTM Pro

6.3 Service Record


STERIS recommend that your InnoWave Pro be serviced every 3 months in accordance with the
schedule contained within the InnoWave Pro Service Manual, which also contains the technical
description of the machine. This record must be completed by the technician conducting the service
and should be made available in the event of a warranty claim or breakdown repair.

Note: No user serviceable parts inside. Service and repair should be referred to trained and qualified
persons only - the product supplier (or STERIS UK Ltd) to avoid personal injury, improper equipment
performance, invalidation of the equipment warranty or other costly damage.

3 Month 6 Month 9 Month


Serviced by/ Serviced by/ Serviced by/
Date Date Date
Cycles since Cycles since Cycles since
last service last service last service
Next service Cycles Date Next service Cycles Date Next service Cycles Date
due due due

12 Month 15 Month 18 Month


Serviced by/ Serviced by/ Serviced by/
Date Date Date
Cycles since Cycles since Cycles since
last service last service last service
Next service Cycles Date Next service Cycles Date Next service Cycles Date
due due due

21 Month 24 Month 27 Month


Serviced by/ Serviced by/ Serviced by/
Date Date Date
Cycles since Cycles since Cycles since
last service last service last service
Next service Cycles Date Next service Cycles Date Next service Cycles Date
due due due

30 Month 33 Month 36 Month


Serviced by/ Serviced by/ Serviced by/
Date Date Date
Cycles since Cycles since Cycles since
last service last service last service
Next service Cycles Date Next service Cycles Date Next service Cycles Date
due due due

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InnoWaveTM Pro

6.4 Operator PIN Number Codes

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 2363 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

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InnoWaveTM Pro

6.5 Symbols Glossary

UL (Underwriters Laboratories)
An American safety consulting and certification company

Protective Earth symbol

Standard Hazard Label (used for Warnings and Hazards)

Standard Electrical Danger Label

Standard Crush Hazard Label

Emergency Stop

Mandatory Read - Read this manual before operating this machine

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