InnoWave Unity User Manual_EN

®
InnoWave™ Unity
Sonic Irrigator
User Manual
InnoWave™ Unity ®
Revision History
Revision Date Summary
1 02 May 2019 First release
COPYRIGHT © 2019 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.
DOC09889-EN i Revision history

Table of Contents
Revision History. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Safety Information
Safety Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Visual symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .x
1– General Information
1.1 Intended use of equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
1.2 Equipment description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
1.3 Additional accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
1.4 Equipment identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
1.5 Manufacturer information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
1.6 Applied standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
1.7 Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
1.8 RoHS requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
1.9 Disposal of unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
2– Specification
2.1 InnoWave™ Unity features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
2.2 Performance specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
2.3 Typical water consumption per wash . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
2.4 Typical power consumption per wash. . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
2.5 Physical dimensions and weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
2.6 Tank dimensions and liquid capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
2.7 Basket internal dimensions and instrument capacity . . . . . . . . . . . . . . . .15
2.8 Working environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
2.9 Electrical power supply requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
InnoWave™ Unity User Manual ii Table of Contents

Table of Contents
3– Installation
3.1 Shipping information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
3.1.1 Shipping crate dimensions and weight . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
3.1.2 Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
3.1.3 Lifting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
3.1.4 Storage markings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
3.1.5 Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
3.2 Removing unit from shipping crate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
3.3 Enclosed items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
3.3.1 Enclosures check list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
3.4 Operating location requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
3.4.1 General and environmental requirements . . . . . . . . . . . . . . . . . . . . . . . . . .27
3.4.2 Operating clearances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
3.4.3 Water supply requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
3.4.4 Site drain requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
3.5 Positioning the InnoWave™ Unity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
3.6 Connecting water inlet hoses and drain hose . . . . . . . . . . . . . . . . . . . . . .31
3.7 Connecting unit to electrical power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
3.7.1 Electrical connection for IW523036 (230 V AC 1P+N+PE) . . . . . . . . . . . . .33
3.7.2 Electrical connection for IW523046 (208 V AC 3P+PE) . . . . . . . . . . . . . . .33
3.8 Switching on electrical power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
3.9 Entering PIN code (if feature enabled). . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
3.10 Setting Time and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
3.10.1 View Time/Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
3.10.2 Set the time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
3.10.3 Set the date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
4– Operator Training
4.1 Recommended operator training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
4.2 Maintaining training records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
InnoWave™ Unity User Manual iii Table of Contents

Table of Contents
5– Preparing for Wash

5.1 Checks and maintenance before every cycle . . . . . . . . . . . . . . . . . . . . . . .40
5.2 Using chemicals with InnoWave™ Unity. . . . . . . . . . . . . . . . . . . . . . . . . . .41
5.2.1 Recommended chemicals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
5.2.2 Replacing chemical bottle in enclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
5.2.3 Priming chemical pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
5.3 Using Unity Basket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
5.3.1 Removing basket from tank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
5.3.2 Loading instruments into basket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
5.3.3 Putting loaded basket in tank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
6– Wash Cycle Operation

6.1 Using touch-screen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
6.1.1 Waking display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
6.1.2 Entering PIN code (if enabled) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
6.1.3 Menu navigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
6.1.4 Main menu functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
6.2 Wash programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
6.2.1 Complete Wash Cycle description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
6.2.2 Soak Cycle description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
6.2.3 Decontamination Cycle description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
6.2.4 Selecting wash program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
6.2.5 Starting wash cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
6.3 Wash cycle stages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
6.3.1 Pre-wash steps shown on display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
6.3.2 Wash steps shown on display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
6.3.3 Rinse steps shown on display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
6.3.4 Final rinse steps shown on display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
6.3.5 Using a Re-wash Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
6.3.5.1 Re-wash Cycle counter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
6.3.5.2 On completion of Re-wash Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
InnoWave™ Unity User Manual iv Table of Contents

Table of Contents
6.4 On completion of wash cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69

6.5 Pausing or aborting wash cycle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
6.5.1 Resume wash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
6.5.2 Abort wash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
6.6 Wash cycle errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
7– Supervisor Menu
7.1 Functions available through Supervisor Menu. . . . . . . . . . . . . . . . . . . . . .74
7.2 Unlocking Supervisor Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
7.3 Changing Supervisor PIN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
7.4 Viewing or editing wash programs settings . . . . . . . . . . . . . . . . . . . . . . . .76
7.5 Setting up a Re-wash Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
7.5.1 Defining a Re-wash Cycle program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
7.6 Changing language used by display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
8– Downloading Wash Cycle Logs

8.1 Recommended USB flash drives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
8.2 Preparing USB flash drive for download. . . . . . . . . . . . . . . . . . . . . . . . . . .83
8.3 Downloading logs from unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
9– Routine Maintenance
9.1 Important safety information:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
9.2 Daily cleaning and inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
9.3 Weekly checks and maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
9.4 Additional accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
9.5 Consumable items. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
9.6 Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
9.7 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
9.8 Servicing by STERIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
InnoWave™ Unity User Manual v Table of Contents

Table of Contents
10 – Full Decontamination
10.1 Performing full decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
10.2 Decontamination certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94
11 – Diagnosing Operation Errors

11.1 Understanding errors reported on display . . . . . . . . . . . . . . . . . . . . . . . . .96
11.2 Problems encountered during operation . . . . . . . . . . . . . . . . . . . . . . . . . .99
11.3 Check Chemical warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .101
11.4 Contacting STERIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
11.4.1 STERIS contact details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
11.5 Preparing unit for transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
12 – Service History
12.1 Maintaining servicing history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105
12.2 Service history record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106
13 – Operator Authorization
13.1 Operator authorization codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107
InnoWave™ Unity User Manual vi Table of Contents

Safety Information
Important
Read this entire manual before attempting to
install, operate or perform any maintenance on WARNING - Breathing hazard
equipment. Make sure all personnel understand
the contents of this manual. Some cleaning solutions emit harmful vapors.
Only use cleaning solutions in well-ventilated
This manual contains important information on areas. Do not inhale vapors. Do not permit
proper use and maintenance of equipment. All solution vapors to exceed maximum allowable
personnel involved in use and maintenance of this concentrations in work area. Make sure area is
equipment must carefully review and comply with well ventilated.
warnings, cautions and instructions contained in
this manual. These instructions are important to
protect health and safety of personnel and should
be retained in conveniently accessible area for WARNING - Electric shock hazard
quick reference.
To avoid risk of electric shock, this equipment
Safety Precautions must be connected to a mains supply with a
protective earth.
The following Safety Precautions must be
Dangerously high voltages are present inside
observed when operating or servicing equipment.
unit. Do not remove any panel or attempt to gain
access to inside unit. Refer servicing and repair
WARNING indicates potential for personal injury.
to qualified personnel only.
CAUTION indicates potential for damage to It is expected that any person servicing or
equipment. repairing unit will be competent technician with
understanding of electrical safety, and risks of
For emphasis, certain Safety Precautions are working with electrical appliances that use
repeated throughout manual. It is important to water.
review ALL Safety Precautions before operating To prevent risk of fire or electric shock, do not
or servicing equipment. expose equipment to unnecessary moisture.
Always make sure all external surfaces are dried
after every cycle.
WARNING - Explosion hazard
When removing basket, allow fluid to drain into
tank before moving to next cleaning station.
Use only water or water-detergent mix in tank.
Excess water spillage may cause electrical
Never use flammable or combustible materials,
shock and serious injury.
gases, or cleaning liquids as such use could
cause fire or explosion. Before inspecting or replacing any part, switch
off and lock, or disconnect electrical supply at
external isolation point. Electrical shock can
cause serious injury.
InnoWave™ Unity User Manual vii Safety Information

Safety Information
WARNING - Chemical burn and/or

eye injury hazard WARNING - Slipping hazard
Chemicals are caustic and can cause adverse To avoid slippery floors, immediately wipe up
effects to exposed tissues. Do not get in eyes, on any spilled liquid or condensation. If spills or
skin or attempt to consume orally. leaks contain detergents or other chemicals,
Read and follow precautions and instructions on follow safety precautions and handling
chemical label and in Safety Data Sheet (SDS) procedures set forth on detergent or chemical
prior to handling chemical, refilling chemical label and/or SDS.
containers or servicing chemical injection pumps
and lines.
Wear appropriate Personal Protective WARNING - Personal injury and/or
Equipment (PPE) whenever handling equipment damage
chemicals or servicing chemical injection pumps hazard
and lines. This should include plastic gloves, Only STERIS or service personnel approved by
goggles or full-face visor, and disposable plastic STERIS may make repairs and adjustments to
apron. Wear appropriate Personal Protective this unit. Maintenance performed by unqualified
Equipment (PPE) whenever removing baskets personnel, or installation of unauthorized parts
or parts from tank. could cause personal injury, result in improper
In instances of body contact with chemical, equipment performance, invalidate warranty, or
always follow emergency procedure given in that result in serious damage.
chemical's SDS or call emergency services. Scheduled preventive maintenance, as
Guidelines to be followed in case of emergency described within service manual, is required for
caused by chemical contact should be safe and reliable operation of this equipment.
prominently displayed near the equipment. Contact STERIS to schedule preventive
maintenance. Failure to perform periodic
inspections of unit could result in serious
personal injury or unit damage.
WARNING - Burn hazard Do not wear loose fitting clothing, neck ties, or
jewelry that could become entangled in moving
Since temperatures within unit can reach +60 °C parts.
(+140 °F) during and after operation, take care Never reach into wash tank when unit is in
when opening lid at end of cycle. Allow sufficient operation.
time for items to cool before handling, cleaning,
or maintenance procedures. Always use basket to reprocess instruments
within unit.
When removing basket from unit with full tank of
hot water, make sure gloves are suitably rated
for thermal protection. Alternatively, wait until
water temperature is below safe limit for PPE
used.
InnoWave™ Unity User Manual viii Safety Information

Safety Information
CAUTION - Chemicals CAUTION - Equipment damage
Since this equipment contains heating device, This equipment should not be used for any
use of substances or chemicals, other than purpose other than that defined by manufacturer
those specified by STERIS, may be hazardous. as an ultrasonic cleaner.
Therefore, always read manufacturer’s chemical Never place items or person(s) on lid as this may
safety information before use and never use result in damage to lid.
toxic, corrosive, or flammable liquids.
Do not drop items into wash tank as this could
damage ultrasonic transducers.
Other chemicals have to be validated by Do not place items directly into wash tank or
equipment owner and proven compatible with allow them to contact tank sides.
the equipment.
Never scratch tank walls. This can increase
cavitation erosion.
Always check expiry date on chemical Do not load basket with instruments pointing
containers before use. towards lid.
Do not overload basket. Basket maximum
Disposal of Chemical Containers weight capacity 11.3 kg (24.9 lb).
For correct disposal of chemical containers, When choosing detergent, select one with low
please refer to manufacturer’s instructions and chloride content. Detergents with high chloride
local regulations. content can be harmful to stainless steel.
Repeated fuse blows, or circuit breaker trips
indicate short circuit or overload. Have fully
trained technician diagnose and remedy
CAUTION - Instrument care situation.
Use non-abrasive cleaners when cleaning
Always confirm compatibility with instrument
equipment. Follow directions on container and
manufacturer.
rub in back and forth motion, in same direction
Always follow manufacturer instructions if as surface grain. Abrasive cleaners damage
processing instruments with special stainless steel. Cleaner rubbed in circular motion
characteristics, e.g. fiber optics or rigid optics. or applied with wire brush or steel wool will
Always follow manufacturer instructions when scratch and dull stainless steel.
pre-processing or post-processing instruments. Avoid impacting display with instruments or
Always open box-jointed instruments. basket during loading and unloading to prevent
damage to controls.
Always disassemble instruments that are
designed to be taken apart. Using non-recommended chemicals,
accessories, or replacement parts may cause
Visually inspect instruments after reprocessing. damage to equipment and could void both
If any instruments became detached from warranty and guarantee of performance.
connection tubing during processing, they
should be reprocessed after making sure luer
connection is firmly attached.
InnoWave™ Unity User Manual ix Safety Information

Safety Information
Visual symbols
Symbol Description
UL (Underwriters Laboratories)
An American safety consulting and
certification company
FCC Declaration of Conformity

Certifies that electromagnetic
interference from device is under
limits approved by Federal
Communications Commission.
Protective earth symbol
Standard hazard label

(used for warnings and hazards)
Standard electrical danger label
InnoWave™ Unity User Manual x Safety Information

1 General Information
Contents of this chapter
1.1 Intended use of equipment . . . . . . . . . . . . . . . . . . . . . . 2

1.2 Equipment description . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3 Additional accessories . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.4 Equipment identification . . . . . . . . . . . . . . . . . . . . . . . . 4
1.5 Manufacturer information . . . . . . . . . . . . . . . . . . . . . . . 5
1.6 Applied standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.7 Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.8 RoHS requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.9 Disposal of unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
InnoWave™ Unity User Manual 1 General Information

1.1 Intended use of equipment

The STERIS InnoWave™ Unity Sonic Irrigator is designed to thoroughly clean
(remove tissue, blood, and other contaminants from) a variety of reusable surgical
instruments. The equipment provides Sonic Irrigation (ultrasonic cavitation) to both
interior and exterior of lumened instruments. The system also uses Lumen Flush to
remove debris from inside channels when instruments are connected to flush manifold.
1.2 Equipment description

The InnoWave™ Unity Sonic Irrigator has stand-alone sonic irrigation, with ability to
wash up to 16 lumens or 11.3 kg (25 lb) of general surgical instruments.
Instruments are loaded into basket with facility to connect to lumen flushing. The user
loads instruments into basket and places it into unit. There are three pre-defined wash
programs with pre-wash, wash, and rinse stages. An additional three wash programs
can be customized by authorized users. An optional Re-wash Program can be
configured to allow the wash water to be reused for up to 10 washes.
Tank filling and draining, and addition of detergent are automatically controlled
according to wash program settings. During wash cycle, parameters are reported at
key stages of process. The on-board cycle log can be downloaded via USB flash drive.
At end of wash cycle, instruments are removed from unit for disinfection and
sterilization.
A class AB weir overflow is incorporated into tank design to comply with water authority
back-flow regulations. The unit is designed to perform within strict and carefully
controlled tolerances. If unexpected condition occurs during wash cycle, system will
abort cycle and report error.

1.3 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 continued and reliable operation of your unit.
Using non-recommended chemicals, accessories, and

replacement parts may cause damage to equipment and could
void both your warranty and guarantee of performance
Caution

1.4 Equipment identification

The following information is displayed on label attached on back wall
of chemical storage compartment.
1. Model name
2. Model reference (model part number)
3. Model serial number
4. Supply voltage requirement
5. Date of manufacture
6. Manufacturer information

1.5 Manufacturer information

The manufacturer of this equipment is as follows:
Manfactured for:
STERIS Corporation
5960 Heisley Rd
Mentor, OH 44060, USA
Manfactured by:
Medisafe UK Ltd.
Twyford Rd
Bishop’s Stortford
Hertfordshire, CM23 3LJ, UK
STERIS Ireland Limited

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

1.6 Applied standards
UL 61010-1:2015 Safety requirements for electrical equipment for measurement,

control, and laboratory use.
CAN/CSA-C22.2 Safety requirements for electrical equipment for measurement,

No. 61010-1-12:2015 control, and laboratory use.
IEC 61010-1:2015 Safety requirements for electrical equipment for measurement,

control, and laboratory use.
IEC 61010-2-040:2015 Particular requirements for sterilizers and washer-disinfectors used to

treat medical materials.
ANSI/AAMI Washer-disinfectors — Part 1: General requirements, terms and

ST15883-1:2009/(R)2014 definitions and tests
(excluding requirements on
disinfection)
ISO 13485:2012 Medical devices - Quality management systems.
ISO 14971:2012 Medical devices - Application of risk management to medical devices.
ISO 15883-1:2006/Amd Washer-disinfectors. General requirements, terms and definitions and

1:2014 tests.
(excluding requirements on
disinfection)
ISO 16142-1:2016 Medical devices -- Recognized essential principles of safety and

performance of medical devices -- Part 1: General essential
principles and additional specific essential principles for all non-IVD
medical devices and guidance on the selection of standards.
BS EN Medical device software. Software life-cycle processes.

62304:2006+A1:2015
CFR 47 FCC Part 15 Tested and complies with FCC and ISED official limits.
Subpart B, Class A: 2016
ANSI C63.4:2014
CISPR Industrial, scientific and medical equipment - Radio-frequency

11:2015+AMD1:2016 CSV disturbance characteristics - Limits and methods of measurement.
PD IEC/TR 60878:2015 Graphical symbols for electrical equipment in medical practice.
PD 5304:2014 Guidance on the safe use of machinery.

1.7 Compliance
A stringent quality management system ensures that every unit is manufactured and
tested under controlled conditions to ensure that all products perform adequately.
1.8 RoHS requirements

STERIS is committed to meeting or exceeding requirements of the RoHS CE Marking
directive (2011/65/EC) (Restriction of the Use of Certain Hazardous Substances in
Electrical and Electronic Equipment).
1.9 Disposal of unit

This product contains materials which may require disposal through appropriately
licensed and permitted hazardous waste management firms.


2 Specification
2.1 InnoWave™ Unity features . . . . . . . . . . . . . . . . . . . . . 10

2.2 Performance specification . . . . . . . . . . . . . . . . . . . . . 11
2.3 Typical water consumption per wash . . . . . . . . . . . . . 12
2.4 Typical power consumption per wash. . . . . . . . . . . . . 12
2.5 Physical dimensions and weight . . . . . . . . . . . . . . . . 13
2.6 Tank dimensions and liquid capacity . . . . . . . . . . . . . 14
2.7 Basket internal dimensions and instrument capacity . 15
2.8 Working environment . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.9 Electrical power supply requirements . . . . . . . . . . . . . 16
InnoWave™ Unity User Manual 9 Specification

2 Specification
2.1 InnoWave™ Unity features

The InnoWave™ Unity SI Contour is a sonic irrigator with heating elements for internal
and external cleaning of surgical instruments. The unit can process up to 16
cannulated instruments in a single wash cycle. A touch-screen display allows user-set
parameters for degassing of water, wash temperature, and wash cycle time. An
internal memory records wash performance data for cycle traceability which can be
downloaded to external USB flash drive.
Features include; sensors to prevent use with lid open, tank water level sensor,
temperature monitoring, program abort, and operation error reporting on display.
Lid Seal
Basket Flush Manifold

Lid
Basket
Touch-screen
Display
Chemical
Enclosure
Air Cooling
Vent
Castors
Image 2.1: Front view, lid and chemical enclosure open

2 Specification
2.2 Performance specification
Equipment designation Healthcare Sonic Irrigator
Classifications Medical device class I

Class 1 electrical shock protection, externally powered
No applied parts
IP rating: IPX0
Not suitable for use in oxygen-rich environment
Designed for continuous use
Intended purpose Internal and external cleaning of surgical instruments, hollow-

ware, and associated products.
Operating process Ultrasonic activity, irrigation ports, and water heating.
Ultrasonic system 18 piezo-electric transducers typically operating at 38 to 40 kHz

dependent on load. 40 W power per transducer. Pulsed degas,
auto-tune, frequency sweep.
Irrigation system Twin 4-port manifolds on 2 corners of basket producing up to

1.5 bar (22.0 psi) at a flow rate of 0.96 L/min. (33.8 fl.oz./min.)
Water temperature Measurement range: +2 ºC to 60 ºC (+36 ºF to 140 ºF)

monitoring Temp. display: +5 ºC to 60 ºC (+41 ºF to 140 ºF), accuracy ±0.5.
Drainage system Unit operated valve and drain pump
Drain outlet 19 mm (3/4 in.) hose tail
Overflow Minimum 40 mm (1.5 in.) ID drain pipe required.

The overflow hose connection to the main drainage system must
not be airtight
Effluent temperature Max. +60 ºC (+140 ºF)
Maximum drain flow rate 30 litres/min. (8 gal/min.) including overflow
User interface 4.3 in. TFT touch-screen display
Audio 1 W speaker
Time Control accuracy: ±0.5 second.

Display: Minutes and seconds.
Internal data storage Micro SD flash card, >4 GB (storage of >10,000 cycles)
Real-time clock battery CR1220 (5012LC), 35 to 40 mAh, 0.1 mA

2 Specification
2.3 Typical water consumption per wash

Water consumption will vary depending on volume of instruments loaded and
temperature of inlet water supply. The water consumption below describes complete
wash cycle at +40 ºC (+104 ºF), with no instruments loaded.
Table 2.1: Maximum water consumption for complete wash cycle
Stage Cold water Hot water Total for stage
Pre-wash 40 litres (10.6 gal) nil 40 litres (10.6 gal)
Wash 16 litres (4.2 gal) 24 litres (6.3 gal) 40 litres (10.6 gal)
Rinse 40 litres (10.6 gal) nil 40 litres (10.6 gal)
Final Rinse 40 litres (10.6 gal) nil 40 litres (10.6 gal)
Total water
136 litres (35.9 gal) 24 litres (6.3 gal) 160 litres (42.3 gal)
consumption
2.4 Typical power consumption per wash

Power consumption will vary depending on cycle settings and temperature of inlet
water supply. The power consumption below describes complete wash cycle at +40 ºC
(+104 ºF).
Table 2.2: Maximum power consumption for complete wash cycle
Stage Total for stage
Pre-wash 10.7 W.hr
Wash 57.2 W.hr
Rinse 6.8 W.hr
Final Rinse 6.8 W.hr
Total power consumption 81.5 W.hr

2 Specification
2.5 Physical dimensions and weight

External height (lid closed) 1079 mm 42.5 in.
External height (lid open) 1495 mm 58.9 in.
External width 881 mm 34.7 in.
External depth 655 mm 25.8 in.
Net weight (dry) 135 kg 298 lb
Operating weight (tank filled) 180 kg 397 lb
Max. operating weight (incl. filled tank,

195 kg 388 lb
chemicals, and instruments to be cleaned)
655 mm
(25.8 in.)
1495 mm
1079 mm (58.9 in.)
(42.5 in.)
881 mm
(34.7 in.) 655 mm
(25.8 in.)
Image 2.2: External dimensions

2 Specification
2.6 Tank dimensions and liquid capacity
Wash tank length 748 mm 29.4 in.
Wash tank width 379 mm 14.9 in.
Wash tank depth 218 mm 8.6 in.
Wash tank liquid volume (maximum) 35.0 litres 9.2 gal
Wash tank total volume 58.0 litres 15.3 gal
218 mm
(8.6 in.)
379 mm
(14.9 in.)
748 mm
(29.4 in.)
Image 2.3: Tank dimensions

2 Specification
2.7 Basket internal dimensions and instrument capacity
Basket length 711 mm 28.0 in.
Basket width 341 mm 13.4 in.
Basket depth 103 mm 4.1 in.
Maximum load weight 11.0 kg 25.0 lb
Maximum instrument size 617 x 260 x 129 mm 24.3 x 10.2 x 5.1 in.
Maximum luer connections 16 (8 flush ports with ‘Y’ connector)
103 mm
(4.1 in.)
711 mm
341 mm (28.0 in.)
(13.4 in.)
Image 2.4: Basket dimensions

2 Specification
2.8 Working environment
Location requirement Interior only, altitude up to 2000 m (6562 ft)
Ambient operating temperature range +5 ºC to 40 ºC (+41 ºF to 104 ºF)
80% relative humidity for up to +31 ºC (+88 ºF)

Maximum humidity decreasing linearly to 50% relative humidity at
+40 ºC (+104 ºF)
61 dBA at distance of 1 m (3.3 ft) from front of

Noise generated during operation
unit
Heat output during operation 205 W (700 BTU/hr) during wash cycle
2.9 Electrical power supply requirements
Model IW523036 IW523046
230 V AC 1P+N+PE 208 V AC 3P+PE

(Single-phase, neutral, and (3-phase and protective earth)
Electrical supply voltage
protective earth) Frequency: 60 Hz
Frequency: 60 Hz
Site Current Capacity > 15 A per phase

Supply current
Site MCB and Disconnect switch current Rating: 16 A MCB
Electrical power
4.0 kW 3.0 kW
requirement
Allowable supply voltage

±10% of nominal voltage
fluctuation
Over-voltage category II Transient over-voltages typically present on mains supply

3 Installation
Always follow local occupational health and safety regulations, as well

as electric and plumbing codes.
Caution
STERIS recommends this product is installed and tested by STERIS-

trained technician (or suitably qualified and approved personnel).
Note
3.1 Shipping information . . . . . . . . . . . . . . . . . . . . . . . . . . 18

3.2 Removing unit from shipping crate . . . . . . . . . . . . . . 20
3.3 Enclosed items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.4 Operating location requirements. . . . . . . . . . . . . . . . . 27
3.5 Positioning the InnoWave™ Unity . . . . . . . . . . . . . . . 30
3.6 Connecting water inlet hoses and drain hose . . . . . . . 31
3.7 Connecting unit to electrical power . . . . . . . . . . . . . . . 32
3.8 Switching on electrical power . . . . . . . . . . . . . . . . . . . 34
3.9 Entering PIN code (if feature enabled) . . . . . . . . . . . . 34
3.10 Setting Time and Date . . . . . . . . . . . . . . . . . . . . . . . . 35
InnoWave™ Unity User Manual 17 Installation

3 Installation
3.1 Shipping information
3.1.1 Shipping crate dimensions and weight
Shipping crate height 1250 mm 49.2 in.
Shipping crate width 1040 mm 40.7 in.
Shipping crate depth 730 mm 28.7 in.
Shipping crate gross weight 170 kg 375 lb
3.1.2 Transportation and storage

Make sure package marking instructions and environmental conditions are always
followed during transport and storage of InnoWave™ Unity.
3.1.3 Lifting
Lifting and maneuvering the InnoWave™ Unity in shipping crate must be done with
pallet truck or forklift truck able to carry load in excess of 176 kg (388 lb).
3.1.4 Storage markings

The markings on shipping crate stipulate unit's storage conditions and handling
information.
Keep dry This way up

3 Installation
3.1.5 Environmental conditions

This equipment can be transported and stored safely in following environment:
+60 °C
Temperature range:
+2 ºC to 60 ºC (+36 ºF to 140 ºF)
+2 °C
106 kPa
Pressure range:
0.50 bar to 1.06 bar (50 kPa to 106 kPa)
50 kPa
90
Humidity range:
% 30% to 90% relative humidity
(non-condensing)
30

3 Installation
3.2 Removing unit from shipping crate
Removing unit from crate should be performed by at least 2

persons trained in manual handling, and will require use of
tools.
Caution
Retain all packing materials. If for any reason unit needs to be

returned to supplier, original crate and packing materials
should be reused.
Note
1. Shipping crate must be positioned to provide sufficient space to remove unit

safely. Make sure there is clear area of at least 2.7 m (8.9 ft) in front of shipping
crate on side marked with words OPEN HERE (Image 3.12).
OPEN HERE
Image 3.1: Clear area required for removing unit from shipping crate
Procedure continues on next page

3 Installation
Procedure continued from previous page
2. Remove screws from top of shipping crate (Image 3.2).
3. Remove top panel of shipping crate and put aside (Image 3.3).
Image 3.2: Removing screws from top of Image 3.3: Removing top of shipping crate
shipping crate
4. With one person holding the side to prevent it falling, remove screws from side of
shipping crate marked with words OPEN HERE (Image 3.4).
5. Remove side panel of shipping crate. Keep this panel as it is required for
unloading unit from shipping crate (Image 3.5).
Image 3.4: Removing screws from side of Image 3.5: Removing side of shipping crate
shipping crate

3 Installation
6. Put side panel removed in previous step on floor with packing foam facing up.
Remove one piece of loose packing foam (Image 3.6). The other piece of
packing foam does not need to be removed.
7. Turn side panel over to create a ramp (Image 3.7).
Image 3.6: Removing packing foam from side of Image 3.7: Turning panel over to make ramp
panel

3 Installation
8. Put ramp in position flush with open side of shipping crate (Image 3.8).
Image 3.8: Ramp in position. Unit ready for

removal from shipping crate

3 Installation
9. Make sure castors are unlocked and free to move. With at least 2 persons, pull
unit forward from shipping crate and guide it slowly down ramp until fully on floor
(Image 3.9).
10. Make sure no items remain in shipping crate. Shipping crate can now be
removed to storage area. It should be kept in case of unit needs to be returned to
supplier.
11. Remove protective cover from unit (Image 3.10)
Image 3.9: Removing unit from shipping crate Image 3.10: Removing protective covering from
unit
12. Remove any protective packing and loose items from inside tank.
13. Retain all packing materials. If for any reason unit needs to be returned to
supplier, original crate and packing materials should be reused.
14. Inspect enclosed items and tick off on 3.3.1: Enclosures check list (page 26)
below.

3 Installation
3.3 Enclosed items

The unit is supplied with range of items for installation and operation. Ensure that all
items are present before attempting to install or operate unit. Complete
3.3.1: Enclosures check list (page 26) and notify your supplier of any shortages or
damaged components as soon as possible.
2 3 4
5 6 7 8
9 10 11 12
pack of 8 pack of 10

3 Installation
3.3.1 Enclosures check list

Make sure all items listed below are enclosed with unit. Mark table with check mark to
confirm item(s) received.
Item Description Qty Checked
1 Unity basket 1
2 Reinforced PVC hose 50mm ID x 1 m long 1
3 Patch cord flex connector 3 m 1
4 Jubilee clip 50 - 70 mm 1
5 Chemical intake pipe 1
6 Water inlet hose with blue indicator 1
7 Water inlet hose, stainless steel 1
8 Gray drain hose 1
9 Jubilee clip 22 - 32 mm 1
10 Access panel key 1
11 Standard hose and luer (pack of 8) 1
12 Distal connector (box of 10 mixed) 1

3 Installation
3.4 Operating location requirements
3.4.1 General and environmental requirements

Proposed operating location for unit much meet or exceed following requirements
Description Requirements
Operating surface On level floor, capable of supporting a weight of at least 195 kg (388 lb).
Altitude Interior only, altitude up to 2000 m (6562 ft)
Ambient operating +5 ºC to 40 ºC (+41 ºF to 104 ºF)

temperature range
Maximum humidity 80% relative humidity for up to +31 ºC (+88 ºF) decreasing linearly to
50% relative humidity at +40 ºC (+104 ºF)
Ambient lighting 500 lux (46.5 foot-candle) minimum room lighting.
Site services Within 1.8 m (6 ft) of electrical isolator.

Within 1.0 m (3 ft) of hot and cold water connections.
Within 1.8 m (6 ft) of external site drain for effluent.

3 Installation
3.4.2 Operating clearances
Operating height including clearances 1566 mm 61.6 in.
Operating width including clearances 1056 mm 41.7 in.
Operating depth including clearances 1215 mm 47.9 in.
Lid Opening
535 mm (21 in.)
Minimum
Side Clearance
75 mm (3 in.)
Minimum
Rear Clearance
150 mm (6 in.)
Door Opening
410 mm (16 in.)
Minimum Side Clearance

100 mm (4 in.)
Image 3.11: Operating clearances

3 Installation
3.4.3 Water supply requirements

The water supply should meet the following requirements:
Water hardness (CaCO3), < 125 ppm with water quality and purity tested as per ANSI/AAMI
quality and purity ST15883-2:2013/(R)2015 (item 6.4.1 and 6.4.2) or AAMI TIR 34
Pressure 2.0 to 5.0 Bar (30 to 70 psi)
Flow rate 11 to 30 litres/min. (3 to 8 gal/min.)
Temperature Cold: +5 to 30 ºC (+41 to 86 ºF)

Hot: +50 to 80 ºC (+122 to 176 ºF)*
Connection 3/4 in. BSP male thread
Position Within 1 m (3 ft) of proposed unit location
* The unit is able to operate without hot water connection or with hot water supply
cooler than recommended minimum temperature of +50 ºC (+122 ºF). Using only
cold water or low-temperature hot water will result in longer cycle operation as
water takes longer to heat up in unit.
3.4.4 Site drain requirements

The site drain should meet the following requirements:
Drain connection 3/4 in. hose tail outlet from unit.

Drain must be fitted with suitable traps.
No loops in the drain hose, cut the hose to length to required.
Position Drain entry and entire drain hose must be below tank overflow level.
Drain gully pipe internal diameter must be at least 100 mm (4 in.)
Capacity > 30 litres/min. (8 gal/min.)
Effluent temperature up to +60 ºC (+140 ºF)

3 Installation
3.5 Positioning the InnoWave™ Unity

1. Inspect proposed operating location for unit and make sure ALL operating
location requirements as described in 3.4: Operating location requirements
(pages 25 to 27) can be achieved.
2. Move unit to operating location.
3. Make sure that minimum operating clearances have been achieved. See
Image 3.11 : Operating clearances (page 28).
4. Make sure that unit is level.
5. Lock castors on unit so that unit cannot move freely from operating location.

3 Installation
3.6 Connecting water inlet hoses and drain hose

1. Make sure water supply meets requirements stated in 3.4.3: Water supply
requirements (page 29)
2. Make sure site drain meets requirements stated in 3.4.4: Site drain requirements
(page 29)
Use instructions below with Image 3.12.
3. Attach Hot Water Inlet Hose (HOSE007) to hot water inlet on unit. Hot water inlet
is located at rear of unit and is labeled HOT, 50 - 80 ºC, 2 - 5 BAR. Turn inlet
hose connector clockwise until hand tight on thread of inlet.
4. Attach Cold Water Inlet Hose (HOSE002) to cold water inlet on unit. Cold water
inlet is located at rear of unit and is labeled COLD, 5 - 30 ºC, 2 - 5 BAR. Turn inlet
hose connector clockwise until hand tight on thread of inlet.
5. Put Jubilee Clip (MED8558) over end of Drain Hose (MED3020).
6. Push drain hose fully onto drain outlet on unit. Drain outlet is located at rear of
unit and is labeled DRAIN.
7. Tighten jubilee clip with socket wrench or slotted screwdriver until water-tight.
Jubilee Clip (MED8558)
Cold Water Inlet Hose
Drain Hose (MED3020)

Hot Water Inlet Hose
Image 3.12: Connecting water inlet and drain hoses

3 Installation
3.7 Connecting unit to electrical power

WARNING - Electric shock hazard
To avoid risk of electric shock, this equipment must be

connected to mains supply with protective earth by fully-
Danger qualified electrician.
Electric shock
risk
WARNING - Electric shock hazard
Make sure model and voltage requirements are checked and

understood before attempting electrical connection. If in doubt
Danger contact STERIS.
Electric shock
risk
The unit must be protected with Miniature Current Breaker (MCB). The MCB should
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 4 kV transient voltage).
• Be situated close to equipment for ease of accessibility, and in position where
the operator can turn it off in emergency without leaning over unit.
• Marked as disconnection device for this equipment.
• Disconnect device off-position should be clearly marked (O) and the
on-position should be marked (l).

3 Installation
3.7.1 Electrical connection for IW523036 (230 V AC 1P+N+PE)

The IW523036 is supplied with 2.5 m (8.5 ft) 3-core power cable. Conductors are color-
coded and marked as follows:
Table 3.1: Conductor color coding
Conductor Color and Marking
Protective earth Green
Live Black 1
Neutral Black 2
3.7.2 Electrical connection for IW523046 (208 V AC 3P+PE)

The IW523046 is supplied with 2.5 m (8.5 ft) 4-core power cable. Conductors are color-
coded and marked as follows:
Table 3.2: Conductor color coding
Conductor Color and Marking
Protective earth Green
Live 1 Black 1
Live 2 Black 2
Live 3 Black 3

3 Installation
3.8 Switching on electrical power

1. Switch on power to unit using isolation switch on wall.
2. On power-on, unit performs Power-On Self-Test (POST) to make sure it is ready

for use. The process takes a few seconds to configure unit and check basic
operation of control system, memory, and sensor interfaces. During POST
Machine Reset screen is shown on display.
Image 3.13: Machine Reset screen
3.9 Entering PIN code (if feature enabled)

If user authorization code feature is enabled on unit, Enter Pin Number screen
(Image 3.14) is shown on display after power-on.
Image 3.14: Enter User PIN screen
1. Use number pad on display to enter operator four-digit PIN number.
2. When acceptable four-digit PIN is entered, display is unlocked and allows

navigation to operation modes.

3 Installation
3.10 Setting Time and Date

The time and date must be set correctly to ensure accuracy of cycle records, and
MUST be periodically checked by operator. There is no automatic provision for daylight
saving hours. When unit is off, backup battery maintains time and date.
3.10.1 View Time/Date
1. On display, touch repeatedly until Time Date screen is shown (Image 3.15).
2. Time and date are shown on display below clock icon. If time or date setting is
not correct it should be reset as described below.
Image 3.15: Time Date screen
3.10.2 Set the time
2. Touch Set Time.
3. Use and to set hours, minutes, and seconds (Image 3.16).
4. Touch to return to main menu.
Image 3.16: Set Time screen

3 Installation
3.10.3 Set the date
2. Touch Set Date.
3. Use and to set day, month, and year (Image 3.17).
4. Touch to return to main menu.
Image 3.17: Set Date screen

4 Operator Training
4.1 Recommended operator training
The owner has responsibility for training and keeping training records
for all persons involved in operating and maintaining this equipment.
Training should be regularly reviewed.
Note
STERIS recommends that training should cover, as a minimum, the following

sections of this manual:
Table 4.1: Recommended Minimum Training
Section Description
Safety Information
5 Preparing for Wash
6 Wash Cycle Operation
9 Routine Maintenance
11 Diagnosing Operation Errors
The table on next page can be used for keeping training records.
InnoWave™ Unity User Manual 37 Operator Training

4 Operator Training
4.2 Maintaining training records

Training of operators should be recorded, and reviewed regularly. The table below can be used
for keeping training records.
Table 4.2: Training records
Date Operator Name Detail of Training Signature of Trainer
InnoWave™ Unity User Manual 38 Operator Training

WARNING
Operators should read this section in it’s entirety before attempting to use
equipment described. Operators must, at all times, observe all warnings and
cautions described in Safety Information.
5.1 Checks and maintenance before every cycle . . . . . . . . .40
5.2 Using chemicals with InnoWave™ Unity . . . . . . . . . . . . .41

5.2.1 Recommended chemicals . . . . . . . . . . . . . . . . . . . . . . . . .42
5.2.2 Replacing chemical bottle in enclosure . . . . . . . . . . . . . . .43
5.2.3 Priming chemical pump . . . . . . . . . . . . . . . . . . . . . . . . . . .44
5.3 Using Unity Basket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45

5.3.1 Removing basket from tank . . . . . . . . . . . . . . . . . . . . . . . .46
5.3.2 Loading instruments into basket. . . . . . . . . . . . . . . . . . . . .48
5.3.3 Putting loaded basket in tank . . . . . . . . . . . . . . . . . . . . . . .51
InnoWave™ Unity User Manual 39 Preparing for Wash

5.1 Checks and maintenance before every cycle

The following checks and maintenance should be performed before every wash
program.
1. Open lid and make sure lid seal is clean and undamaged (Image 5.1).
2. Inspect basket. Make sure basket manifolds, located in 2 corners of basket, are
undamaged and in good condition (Image 5.2). Make sure luer hoses have no
kinks or ruptures.
3. Make sure tank docking ports are clear of any debris or deposits (Image 5.3).
4. Inspect filter by removing from tank (Image 5.4). Clean filter if dirty or clogged.
5. Clean all internal surfaces above water level on tank. Make sure tank is clear of
any debris or deposits.
LID SE
SEAL
EAL
Image 5.1: Location of lid seal Image 5.2: Basket manifold (x2) on basket
1. L
LIFT
IFT
IFT
TANK
T
TA
A FILTER
TER
ER
DOCKING
DOC
DO C
PORT
TANK
NKK
DOCKING
KIN
NG
PORT
RTT 2. P
PULL
ULL
UL L AWAY
AWA
AWA
Image 5.3: Tank docking ports and filter Image 5.4: Removing filter

5.2 Using chemicals with InnoWave™ Unity

During wash cycle, unit automatically delivers measured dose of chemical into tank.
The chemical bottle is stored in chemical enclosure under tank and connects to unit
with chemical intake hose.
WARNING - Chemical burn and/or eye injury hazard
Chemicals are caustic and can cause adverse effects to exposed tissues. Do not
get in eyes, on skin or attempt to consume orally.
Read and follow precautions and instructions on detergent label and in 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 tank.
In instances 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 equipment.

5.2.1 Recommended chemicals

replacement parts may cause damage to the unit and could
void both your warranty and guarantee of performance.
Caution
STERIS does not promote, recommend, or endorse the use of
any type of chemical additives, such as strong alkaline

detergents (pH>12), alcohol rinses, liquid germicides including
Note hypochlorites, in processing of articles in the InnoWave™
Unity Sonic Irrigator.
Selection of chemical additives is open to customer preference. To achieve optimal

performance, selected chemical additives must meet, as a minimum, the following
descriptions:
Table 5.1: Recommended chemicals
Part Number Description
1C3308 Prolystica 2X enzymatic pre-soak and cleaner (4 x 1 gallon)
1C3310 Prolystica 2X enzymatic pre-soak and cleaner (2.5 gallons)
1C2210 Prolystica HP Automated/Manual Washing Enzymatic
Note: Certain products may not be available in your area. Contact STERIS for
product availability and ordering information.

5.2.2 Replacing chemical bottle in enclosure
1. Open door of chemical enclosure.
2. Remove chemical intake hose from empty detergent bottle (Image 5.5).
3. Remove chemical bottle from chemical enclosure.
4. Put new chemical bottle in chemical enclosure.
5. Remove lid from new chemical bottle.
6. Put chemical intake hose into new chemical bottle. Make sure chemical intake
hose reaches bottom of chemical bottle (Image 5.6).
7. Close door of chemical enclosure.
8. The chemical pump must now be primed to prevent chemical cross-

contamination. See 5.2.3: Priming chemical pump (page 44).
Image 5.5: Removing chemical intake hose Image 5.6: Chemical intake hose in chemical
bottle

5.2.3 Priming chemical pump

The chemical pump must be primed whenever chemical bottle is changed, or if
chemical hose is removed from chemical bottle. Priming chemical pump prevents
cross-contamination when changing chemical bottle.
1. From main menu, on display touch or repeatedly until Prime Chem.

Pump screen (Image 5.7) is shown.
2. Touch Prime Chem. Pump. A measured quantity of chemical is pumped into unit
(Image 5.8).
3. Repeat step 2. until chemical from new bottle can be seen entering tank.
4. The chemical pump priming can be stopped during dispensation by touching

Prime Chem. Pump when shown in blue (Image 5.8).
Image 5.7: Prime Chem. Pump screen Image 5.8: Chemical pump priming unit

5.3 Using Unity Basket
WARNING - Chemical burn and/or eye injury hazard
Chemicals are caustic and can cause adverse effects to exposed tissues. Do not
get in eyes, on skin or attempt to consume orally.
Read and follow precautions and instructions on chemical label and in 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 tank. In instances 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 equipment.

5.3.1 Removing basket from tank
CAUTION - Burn hazard
Since temperatures within unit can reach +60 °C (+140 °F) during and after
operation, take care when opening lid at end of cycle. Allow sufficient time for items
to cool before handling, cleaning, or maintenance procedures.
When removing basket from unit with full tank of hot water, make sure gloves are
suitably rated for thermal protection. Alternatively, wait until water temperature is
below safe limit for PPE used.
1. Open lid of unit.

If unit has recently completed wash cycle, open lid slowly and be
cautious of hot vapor that may be present inside chamber.
Caution
2. Hold basket handles with both hands (Image 5.9).
3. Pull both basket handles. Handles rotate about pivot and push side latches away
to release basket (Image 5.10).
Image 5.9: Grip basket handles Image 5.10: Pull handles up to release basket
4. Remove basket from tank by lifting up using basket handles. Keep basket level
until completely free from tank.

5. With basket above tank, tilt basket to allow fluid to drain into tank.
6. Remove basket from unit and take to a draining area away from the unit to allow
any residual fluid to drain out.
7. Disconnect luer hoses from basket manifold and remove distal connectors from
instruments.
7.1. Push retaining clip on flush port to release connection hose (Image 5.11).
7.2. Pull connection hose to disconnect from flush port (Image 5.12).
8. Remove instruments from basket.
PUSH
SH PUL
PULL
Image 5.11: Push flush port retaining clip Image 5.12: Pull luer hose to disconnect from
flush port

5.3.2 Loading instruments into basket
CAUTION - Instrument selection and loading precautions
• Always confirm compatibility with the instrument manufacturer.

• Always refer to instrument manufacturer instructions prior to placing in
InnoWave™ Unity sonic irrigator.
• Do not drop items into wash tank as this could damage the ultrasonic
transducers.
• Do not place items directly into wash tank or allow them to make contact with
tank sides or bottom.
• Do not load basket with instruments pointing at lid or water level sensor.
• Do not overload basket, maximum load of 11.0 kg (25 lb).
• Do not allow luer hoses to protrude outside basket.
• Always attach tubing to suitable size distal connector for instruments being
cleaned or to quick connect port if instrument has one.
• Always connect instruments of similar bore size to the same manifold.
• Always open box jointed instruments.
• Always open taps on cannulated instruments.
• Always disassemble instruments that are designed to be taken apart.

1. Select topmost available flush port on basket manifold located on basket

(Image 5.13).
2. Push end of luer hose with 3/16 in. connector attached into flush port
(Image 5.14). Make sure connector is fully inserted. A retaining clip will click to
lock connector in position.
Always attach luer hose to topmost available flush port on
basket manifold. The bottom flush manifold port should only

be used when all other flush ports have luer hoses attached
Note (Image 5.13).
1 TOP
2
3
4 BOTTOM P US
PUSH
Image 5.13: Flush port connection order Image 5.14: Connecting hose to flush
manifold
3. Attach free end of luer hose to instrument to be cleaned, or distal connector.

Additional steps if distal connection is required:

4. Select size of distal connector that best fits instrument to be cleaned. Instrument
must not be clamped tightly by distal connector and should allow water flow
around instrument.
5. Attach free end of luer hose to distal connector by twisting blue luer lock
clockwise until tight (Image 5.15).
6. Attach instrument to be cleaned to distal connector (Image 5.16).
7. Put instrument in basket. Make sure instrument does not protrude through or
above basket (Image 5.17).
Image 5.15: Connecting luer hose to distal Image 5.16: Attaching instrument to distal
connector connector
Image 5.17: Example of loaded basket

5.3.3 Putting loaded basket in tank
1. Open lid.
2. With both hands, lift basket using handles.
3. Slowly lower basket into tank, keeping it level at all times (Image 5.18).
4. Make sure side latches engage on both sides of basket. Push down on basket
until the side latches are engaged (Image 5.19).
5. Make sure that no instruments protrude through or above basket and that no
instruments are pointing upwards.
Image 5.18: Lower basket into tank Image 5.19: Side latches engaged over basket



WARNING
Operators should read this section in it’s entirety before attempting to operate
equipment described. Operators must, at all times, observe all warnings and
cautions described in Safety Information.

6.1 Using touch-screen Display . . . . . . . . . . . . . . . . . . . . .54
6.1.1 Waking display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
6.1.2 Entering PIN code (if enabled) . . . . . . . . . . . . . . . . . . . .54
6.1.3 Menu navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
6.1.4 Main menu functions . . . . . . . . . . . . . . . . . . . . . . . . . . .55
6.2 Wash programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56

6.2.1 Complete Wash Cycle description . . . . . . . . . . . . . . . . .57
6.2.2 Soak Cycle description. . . . . . . . . . . . . . . . . . . . . . . . . .57
6.2.3 Decontamination Cycle description . . . . . . . . . . . . . . . .57
6.2.4 Selecting wash program. . . . . . . . . . . . . . . . . . . . . . . . .58
6.2.5 Starting wash cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
6.3 Wash cycle stages . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60

6.3.1 Pre-wash steps shown on display . . . . . . . . . . . . . . . . .61
6.3.2 Wash steps shown on display . . . . . . . . . . . . . . . . . . . .62
6.3.3 Rinse steps shown on display . . . . . . . . . . . . . . . . . . . .64
6.3.4 Final rinse steps shown on display. . . . . . . . . . . . . . . . .65
6.3.5 Using a Re-wash Cycle . . . . . . . . . . . . . . . . . . . . . . . . .66
6.4 On completion of wash cycle . . . . . . . . . . . . . . . . . . . .69
6.5 Pausing or aborting wash cycle . . . . . . . . . . . . . . . . . .71

6.5.1 Resume wash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
6.5.2 Abort wash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
6.6 Wash cycle errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
InnoWave™ Unity User Manual 53 Wash Cycle Operation

6.1 Using touch-screen Display

The touch-screen display provides access to user functions, and displays information
about unit and wash cycle.
6.1.1 Waking display

If unit is inactive for more than 10 minutes, display enters screen-saver mode. To wake
display, touch anywhere on display.
6.1.2 Entering PIN code (if enabled)

If operator authorization code is required, Enter Pin Number screen will appear on
display (Image 6.3).
1. Use number pad on display to enter operator four-digit PIN number.
2. When acceptable PIN is entered, display unlocks main menu.
Image 6.1: Enter User PIN screen
6.1.3 Menu navigation

The icons (scroll left) and (scroll right), are used to move through operation
screens. The icon at center indicates current selection (Image 6.2). Options are usually
shown at bottom of display in white text on dark background.
Image 6.2: Example screen display

6.1.4 Main menu functions

The main menu icons allow access to functions described below: To return to main
menu from any selection, touch icon at top left of display.
Table 6.1: Main menu icons and functions
Icon Name Functions
Start Cycle Start automated cycle sequence for selected

program.
Wash Program Allows user to select the wash program from preset
P selection.
Prime Chemical Allows user to prime chemical pump with set dose
1 Pump of chemical.
Clock Allows user to adjust time and date settings used

by unit for display and data logging.
Supervisor Menu Allows authorized access to configure wash

programs, language settings, and ability to change
supervisor PIN.
Data Logging Allows user to download logged cycle data onto

LOG USB flash drive.
Information Displays serial number of unit, total cycle count,

and current software version.

6.2 Wash programs

The InnoWave™ Unity has three locked preset wash programs installed. A further
three user-customizable (unlocked) wash programs are available. The user-
customizable program parameters can be set in the Supervisor Menu (7: Supervisor
Menu‚ page 73).
Table 6.2: Wash program settings
Stage Setting P1 P2 P3 P4 P5 P6
(locked) (locked) (locked)
Program Name
Open
Open
Open
Decontamination
Complete Wash Cycle
Soak Cycle
Prewash Duration (mins.) 1 5 0 0 0 0
Times performed 1 1 0 0 0 0
Degas Duration (mins.) 1 0 3 3 3 1
Wash Chemical Dose 3.38 5.07 3.38 3.38 3.38 0.0

fl.oz. fl.oz. fl.oz. fl.oz. fl.oz. fl.oz.
Temperature 104 °F 104 °F 104 °F 104 °F 104 °F 104 °F
Duration (mins.) 1 30 5 5 5 30
Rewash Cycles without 0 0 0 0 0 0

draining
Rinse Temperature 32 °F 32 °F 32 °F 32 °F 32 °F 32 °F
Times performed 1 1 0 0 0 1
Final Rinse Temperature 32 °F 32 °F 32 °F 32 °F 32 °F 32 °F

6.2.1 Complete Wash Cycle description

The factory-preset Complete Wash Cycle is validated to clean with certainty 12 kg
(26.5 lb) of surgical instruments.
Instruments go through pre-wash stage in which they are washed and flushed using
cold water to dislodge visible soil/blood particles. The use of cold water during this
stage avoids blood clotting or formation of protein prions.
The wash stage uses 100 ml (3.52 fl.oz) of chemical. Ultrasonics and lumen flushing
dislodge any remaining particles on instruments.
After wash stage, instruments are rinsed to remove chemical and any remaining soil.
On completion of rinsing, instruments are ready for disinfection processing.
6.2.2 Soak Cycle description

The factory-preset Soak Cycle precedes normal washing and disinfection.
Instruments go through pre-wash stage in which they are washed and flushed using
cold water to dislodge visible soil/blood particles. The use of cold water during this
stage avoids blood clotting or formation of protein prions.
The wash stage uses 150 ml (5.07 fl.oz) of chemical and soaks instruments for 30
minutes. Ultrasonics and lumen flushing dislodge any remaining particles on
instruments.
After wash stage, instruments are rinsed to remove chemical and any remaining soil.
On completion of rinsing, instruments are ready for disinfection processing.
6.2.3 Decontamination Cycle description

The factory-preset Decontamination Cycle is used to perform Full Decontamination of
unit. Full Decontamination procedure is detailed in 10.1: Performing full
decontamination (page 93).

6.2.4 Selecting wash program
1. On display, touch or repeatedly until Select Program screen is shown

(Image 6.3).
Image 6.3: Select Program screen
2. Touch + to select next wash program, or touch

_
to select previous wash
program. Move through wash programs until desired wash program appears on
display. For details of selectable wash programs see 6.2: Wash
programs (page 56).
3. With desired program name shown on display, touch to return to Load

Instruments screen.
Image 6.4: Load Instruments screen

6.2.5 Starting wash cycle
1. From main menu, touch or repeatedly until Load Instruments screen is

shown on display (Image 6.5).
2. Confirm wash program shown on display matches desired wash program. If

desired wash program is not shown see 6.2.4: Selecting wash
program (page 58)
3. Touch Load Instruments.
Image 6.5: Load Instruments screen
4. Load instruments into basket. Follow instructions in 5.3.2: Loading instruments

into basket (page 48).
5. Put loaded basket in tank. Follow instructions in 5.3.3: Putting loaded basket in
tank (page 51).
6. When instruments have been loaded, and lid is closed, wash cycle can begin.
7. Touch Start on Load Instruments - If all loaded screen (Image 6.6). The wash
cycle will start and progress through each stage as required.
Image 6.6: ‘Load Instruments - If all loaded’

screen

6.3 Wash cycle stages

The stages of Complete Wash Cycle (P1) are described below. Note: Other wash
cycles may not include all steps described.
• Confirm Confirm unit is loaded and ready to start.

Start
Cycle
• Filling Tank fills from hot and/or cold water inlets.
• Flushing Pulsed lumen flushing.
Pre-wash • Draining Water drains from tank.
• Filling Tank fills from hot and cold water inlets.

• Dispensing Chemical added after minimum tank level achieved.
• Heating Water heated to set point, circulating through lumens.
• Degassing Ultrasonics pulsed to degas water.
Wash
• Ultrasonics / Flushing Alternates between ultrasonics and lumen flushing.
• Draining Water drains from tank.
• Filling Tank fills from cold water inlet.

• Flushing Lumen flushing.
Rinse • Draining Water drains from tank.
• Filling Tank fills from cold water inlet.

• Ultrasonics / Flushing Lumen flushing.
Final • Draining Water drains from tank.
Rinse
• Confirm Acknowledge cycle completed.
• Unload Unload basket and confirm on touch-screen.
Cycle
Complete
Image 6.7: Cycle stages

6.3.1 Pre-wash steps shown on display

The display shows progress through pre-wash stage. The display is described in detail
below:
Table 6.3: Pre-wash cycle steps
Display Stage Activity
Filling
Tank is filled from hot and/or cold water
supply Temperature of tank water is
shown on left. Time elapsed during filling
is shown on right.
Flushing
Lumen flushing for duration of set time.
Time remaining for stage is shown on
right.
Draining
Water is drained from tank. Time
elapsed during stage is shown on right.
When unit detects tank is empty, drain

pump runs for further period to remove
any remaining water.

6.3.2 Wash steps shown on display

The display shows progress through wash stage. The display is described in detail
below:
Table 6.4: Wash cycle steps
Filling
supply. Temperature of tank water is
shown on left. Time elapsed is shown on
right.
Dispensing detergent
Chemical is added after bottom of tank
level is achieved. The volume of
chemical dispensed is shown lower
right. Time elapsed is shown middle
right.
Heating
Tank water is heated to set point. Water
is circulated through lumens to equalize
temperature. Temperature of water is
shown on left.
Degassing
Ultrasonics are pulsed on and off for set
time to remove dissolved gases in water.
This maximizes efficiency of ultrasonic
cavitation. Time remaining for stage is
shown on right.

Table 6.4: Wash cycle steps (Continued)
Ultrasonics / Flushing
Alternates between ultrasonics and
lumen flushing for duration of set period.
Time remaining for stage is shown on
right.
Draining
elapsed is shown on right.

pump runs for a further period to remove

6.3.3 Rinse steps shown on display

The display shows progress through rinse stage. The display is described in detail
below:
Table 6.5: Rinse cycle steps
Filling
Tank is filled from hot and cold water
right.
Flushing
Lumen flushing for duration of set
period. Time remaining is shown on
right.
Drain

pump runs for a further period to remove

6.3.4 Final rinse steps shown on display

The display shows progress through final rinse stage. The display is described in detail
below:
Table 6.6: Final rinse cycle steps
Filling
right.
Flushing
Lumen flushing for duration of set time.
Time remaining is shown on right.
Drain

pump runs for further period to remove

6.3.5 Using a Re-wash Cycle

A Re-wash Cycle must be setup by user with supervisor access before it can be
selected in main menu. After a Re-wash Cycle has been setup through Supervisor
Menu, it can be selected.
6.3.5.1 Re-wash Cycle counter

During Re-wash Cycle, screen will display counter showing how many times same
washing water has been used (Image 6.8).
re-wash counter
Image 6.8: Re-Wash screen indicating

washing water used for second
time
When number of re-wash cycles reaches maximum cycles allowed as set using
Supervisor Menu, tank will drain at end of cycle.

6.3.5.2 On completion of Re-wash Cycle
Since temperatures within unit can reach +60 °C (+140 °F) during and after
operation, take care when opening lid at end of cycle. Allow sufficient time
for items to cool before handling, cleaning, or maintenance procedures.
When removing basket from unit with full tank of hot water, make sure gloves
are suitably rated for thermal protection. Alternatively, wait until water
temperature is below safe limit for PPE used.
1. At end of Re-wash Cycle, if Re-wash Counter is below number of allowed re-

washes in program settings, fluids remain in tank. Procedure for next Re-wash
Cycle is as follows:
1.1. Cycle Complete - Unload screen is shown on display (Image 6.9).
Image 6.9: Cycle Complete Unload screen
1.2. Open lid slowly and partially to allow hot vapors to escape from chamber.
When vapors have escaped, lid can be opened fully.
1.3. Remove basket from tank full of fluids.

1.4. Touch OK on Cycle Complete - Unload screen to confirm unloading of

instruments. Wash End screen is shown (Image 6.10).
Image 6.10: Wash End screen
1.5. To re-use tank water, touch Yes on Wash End screen. Reload screen will
be shown (Image 6.11). (If you do not want to reuse tank water, touch No.
Tank water will automatically be drained. Next wash program is then
selected by operator from main menu.)
Image 6.11: Re-wash Reload screen
1.6. Slowly put basket loaded with instruments to be cleaned into tank full of
fluids. Be careful of hot water splashes.
1.7. Touch Reload Complete on Reload screen to confirm loading of

instruments.
1.8. Re-Wash Cycle starts.
2. If Re-wash Counter has reached number of allowed re-washes in program

settings, fluids are drained from tank. Unloading of instruments procedure is then
same as for Complete Wash Cycle. Next wash cycle is then selected by operator
from main menu.

6.4 On completion of wash cycle

The procedure below describes completion of wash cycle when Re-wash Cycle is NOT
selected. If Re-wash Cycle selected follow procedure 6.3.5.2: On completion of Re-
wash Cycle (page 67)
1. When wash cycle finishes, unit makes sound (chime) and Cycle Complete
screen (Image 6.12) is shown.
Image 6.12: Cycle Complete screen
2. Confirm cycle record is present and indicates cycle completed with no errors.
3. Touch Unload on display to confirm cycle complete.
4. Remove basket from tank. Follow instructions in 5.3.1: Removing basket from
tank (page 46).
5. Remove instruments from basket.
If any instrument has detached from luer hose or distal

connector, or luer hose appears restricted due to instrument
movement, the instrument should be reprocessed.
Warning

6. Touch OK on display to confirm basket and instruments have been unloaded

(Image 6.13).
Image 6.13: Cycle Complete Unload - Touch

OK to confirm unloading
7. The unit is now ready for next wash cycle.

6.5 Pausing or aborting wash cycle

During wash cycle, it is possible to pause or abort wash program if required.
1. On display, touch icon at top left of screen. The wash cycle is paused and
Cycle Paused screen is shown (Image 6.14).
Image 6.14: Cycle Paused screen
The wash cycle will also pause if lid is opened during operation. To resume wash cycle,
close lid and touch Resume on display.
The Cycle Paused screen allows two selections; Abort wash, Resume wash.
6.5.1 Resume wash
1. To resume wash cycle, touch Resume icon on Cycle Paused screen.
6.5.2 Abort wash
1. On Cycle Paused screen, touch Abort. The wash cycle is aborted and Program
Aborted screen (Image 6.15) is shown.
1. Touch OK on Program Aborted screen. The unit will reset. The Machine Reset
screen will be shown, shortly followed by Load Instruments screen (Image 6.16).
Image 6.15: Program Aborted screen Image 6.16: Load Instruments screen

6.6 Wash cycle errors

When error occurs during wash cycle, load may be contaminated
and require reprocessing. Review cycle log to establish if wash

cycle completed before error. If error interrupted wash cycle,
Warning repeat cycle to reprocess load. If error persists use another unit
or alternative cleaning process (according to facility procedure)
and contact STERIS to have unit serviced.
If unexpected condition occurs, unit will abort wash cycle, emit audible alarm, and
display error message with reason for abort (Image 6.17). The cycle log will record
error code, description of error, and diagnostic information.
1. The reason for abort should be investigated. Use 11: Diagnosing Operation
Errors‚ page 95, to lookup error code and follow advice given.
2. After recording error code reported, touch OK on display to confirm error has
been recognized.
3. If tank was not empty when abort occurred, tank will empty automatically
(Image 6.18). The unit will then reset and return to main menu.
4. Instruments must be processed if error occurred during wash cycle.
Image 6.17: Example of error display Image 6.18: Tank draining after wash cycle
abort

7 Supervisor Menu

7.1 Functions available through Supervisor Menu . . . . . . 74
7.2 Unlocking Supervisor Menu . . . . . . . . . . . . . . . . . . . . 74
7.3 Changing Supervisor PIN . . . . . . . . . . . . . . . . . . . . . . 75
7.4 Viewing or editing wash programs settings . . . . . . . . 76
7.5 Setting up a Re-wash Cycle . . . . . . . . . . . . . . . . . . . . 79
7.6 Changing language used by display . . . . . . . . . . . . . . 82
InnoWave™ Unity User Manual 73 Supervisor Menu

7 Supervisor Menu
7.1 Functions available through Supervisor Menu

The supervisor menu unlocks access to following settings:
• PIN used to unlock supervisor menu.

• View factory-set wash programs settings.
• Edit user-definable wash programs settings.
• Language used by display and connected printer.
7.2 Unlocking Supervisor Menu
1. On display, from main menu, touch , or repeatedly until Supervisor Menu

(Image 7.1) is shown.
2. Touch once on Supervisor Menu.
3. Use number pad on display to enter valid 6-digit supervisor PIN number
(Image 7.2).
Image 7.1: Supervisor Menu screen Image 7.2: Enter Supervisor PIN screen

7 Supervisor Menu
7.3 Changing Supervisor PIN

1. Unlock Supervisor Menu as described in 7.2: Unlocking Supervisor
Menu (page 74).
2. Touch or repeatedly until Enter New Pin screen is shown (Image 7.3).
3. On display, enter desired new supervisor PIN (Image 7.4).
4. Enter new supervisor PIN a second time to confirm change (Image 7.5).
5. If supervisor PIN entered first and second time do not match, supervisor PIN will
not be changed and you must try again (Image 7.6).
6. If supervisor PIN entered first and second time match, PIN is changed and
display will return to Supervisor Menu - Enter New Pin screen (Image 7.3).
Image 7.3: Supervisor Menu - Enter New Image 7.4: Enter new supervisor PIN
PIN screen
Image 7.5: Confirming new supervisor PIN Image 7.6: PIN entered first and second
time do not match
If supervisor PIN is forgotten, it can only be reset by Service

Technician. A service visit to reset supervisor PIN is not covered
by warranty, and will be chargeable to the customer.
Note

7 Supervisor Menu
7.4 Viewing or editing wash programs settings

Menu (page 74).
2. Touch or repeatedly until wash program to be viewed/edited is shown.

Factory-set wash programs have a padlock icon and can only be viewed
(Image 7.7). User-definable wash programs do not have a padlock icon and can
be edited (Image 7.8).
3. Touch View Program # to view factory-set wash program, or touch

Edit Program # to edit user-definable wash program.
Image 7.7: Locked wash cycle Image 7.8: Editable wash cycle
4. Touch to scroll forward through wash program settings. Touch to go back

to previous screen.
5. On editable wash programs, use and to adjust wash program settings.

Table 7.1: Wash program settings
Display Settings
Program Name
Wash program name that is displayed
on user menu.
Use display keypad to enter desired

wash program name. Use to scroll to
next setting display when done. Program
name is limited to display width and
maximum of 30 characters.

7 Supervisor Menu
Table 7.1: Wash program settings (Continued)
Display Settings
Pre-wash
Duration setting for pre-wash stage is
shown on left. Range: 0 to 20 minutes.
Number of times pre-wash stage will be

performed is shown on right. If set to
zero pre-wash stage will be skipped.
Range: 0 to 3 times.
Use and to adjust settings.
Degassing
Duration setting for degassing is shown.
If set to zero degassing stage will be
skipped. Range: 0 to 10 minutes.
Use and to adjust setting.
Washing
Quantity of chemical added during wash
is shown on left. Range: 0 to 67.62 fl.oz.
Temperature setting of wash stage is

shown center. Range: +32 to 140 °F.
Duration setting for wash stage is shown

on right. Range: 0 to 40 minutes.
Rewash
If set, rewash holds wash water in tank
and does not drain. This allows tank
water to be reused for additional wash
cycles.
STERIS recommend this setting is

always set to 0x (no rewashes).
Use and to adjust setting.

7 Supervisor Menu
Table 7.1: Wash program settings (Continued)
Display Settings
Rinsing
Temperature setting of rinsing stage is
shown on left. Range: +32 to 140 °F.
Duration setting for rinsing stage is

shown center. Range: 0 to 20 minutes.
Number of times rinsing stage will be

performed is shown on right. If set to
zero rinsing stage will be skipped.
Range: 0 to 3 times.
Final Rinse
Temperature setting of rinsing stage is
shown on left. Range: +32 to 140 °F.
Duration setting for rinsing stage is

shown on right. Range: 0 to 20 minutes.
Save Changes
If wash program is locked, only option
displayed is Cancel. Display will exit
wash program settings and return to
Supervisor main menu.
If wash program is unlocked and wash

program settings have been changed,
touch OK to confirm changes, or Cancel
to abort changes.

7 Supervisor Menu
7.5 Setting up a Re-wash Cycle

A Re-Wash Cycle allows user to retain washing water and chemical in tank for use in
next wash cycle, reducing wash time and water and chemical use. At end of first re-
wash, cycle water and chemical is retained in tank and does not drain. User removes
basket and after reloading with instruments puts basket back into full tank.
A Re-wash Cycle is intended for heavily soiled instruments only. On completion of re-
wash cycle, it is strongly recommended that instruments are further processed in
Complete Wash Cycle to rinse off any remaining soil and chemicals.
The Re-wash Cycle counts number of times same tank fluids are used. The re-use limit
can be set in Supervisor Menu up to maximum of 10 washes.
If tank water temperature exceeds set point by more than 10°C

(50°F), cycle will be aborted.
Note

7 Supervisor Menu
7.5.1 Defining a Re-wash Cycle program

A Re-wash Cycle program can only be defined by operator with supervisor access.
After a Re-wash Cycle has been defined and saved through supervisor access, all
users are able to select the Re-wash Cycle from main menu.
1. Unlock Supervisor Menu as described in 7.2 Unlocking Supervisor

Menu (page 74).
2. Touch or repeatedly until desired user-definable (unlocked) wash

program is shown. User-definable wash programs do not show a padlock icon
and can be edited (Image 7.9).
Image 7.9: User-definable (unlocked) wash

program
3. Touch Edit Program # to set parameters for re-wash program.
4. Use keypad on display to enter name that identifies program as Re-wash Cycle.
This name will be shown on user main menu (Image 7.10).
Image 7.10: Setting name for program
5. Touch to move to wash program parameters screen.

7 Supervisor Menu
6. Use and to set Re-wash Cycle program parameters. Use Table

7.1: Wash program settings (page 76) if guidance on setting parameters is
required.
7. On Rewash screen, use and to set to number of times tank fluids can be
used.
Image 7.11: Setting number of times tank

fluids can be reused
8. Touch to move through all of wash program parameters and set desired
values.
9. When Save Changes screen (Image 7.12) is shown, touch OK to save wash
program, or touch Cancel to discard settings.
Image 7.12: Save Changes to wash program
10. When Re-wash Cycle has been saved, it can be selected from Main Menu.

7 Supervisor Menu
7.6 Changing language used by display

Menu (page 74).
2. Touch or repeatedly until Language screen is shown (Image 7.13).
3. Touch once on Language.
4. Touch or repeatedly until desired language is shown (Image 7.14).
5. Touch OK to confirm change of language.
6. Language is changed and display returns to Supervisor Menu screen.
Image 7.13: Supervisor Menu - Language Image 7.14: Language setting confirmation
screen
Available languages appear in the following order:
Table 7.2: Available languages
Order Language Order Language
1 English 9 Italian
2 Danish 10 Polish
3 French 11 Russian
4 German 12 Portuguese
5 Japanese 13 Norwegian
6 Spanish 14 Lithuanian
7 Swedish 15 Latvian
8 Finnish back to 1

8 Downloading Wash Cycle Logs

The InnoWave™ Unity has internal memory capable of keeping information on more
than 10,000 wash cycles. This information can be transfered to USB flash drive for
external storage or analysis.
8.1 Recommended USB flash drives

STERIS recommend the following brands;
• Toshiba TransMemory
• Kingston DataTraveler
• SanDisk Cruzer Switch
8.2 Preparing USB flash drive for download

1. Make sure USB flash drive is formatted FAT32.
InnoWave™ Unity User Manual 83 Downloading Wash Cycle Logs

8.3 Downloading logs from unit

1. Put USB flash drive in USB data port. USB data port is located inside chemical
enclosure of InnoWave™ Unity (Image 8.1).
USB
SB
DATA
ATA
PORT
Image 8.1: USB Data Port inside chemical enclosure
2. On display, navigate to Download Logs to USB (Image 8.2).
3. All Logs downloads all wash cycles since unit was first operated.
4. New Logs downloads wash cycles since last USB download.
5. Choose and touch All Logs or New Logs.
6. Wait for logs to be copied to USB flash drive. The display will show number of
files being copied and progress bar (Image 8.3).
Image 8.2: Download Logs to USB screen Image 8.3: USB Logs Downloading screen

7. When download to USB flash drive is complete, display will show that copy is
complete and is safe to remove USB flash drive (Image 8.4).
Image 8.4: USB Download Complete

screen
8. Remove USB flash drive from InnoWave™ Unity.
9. On USB flash drive, wash cycle logs are saved as:
STERIS\<machine serial number>\<cycle range>\<cycle number>.txt
10. Touch OK on display to exit USB download screen.


9 Routine Maintenance
No user serviceable parts inside. Service and repair should be referred to trained
and qualified persons only - the product supplier (or STERIS) - to avoid personal
injury, improper equipment performance, invalidation of equipment warranty, or
Warning other costly damage.
9.1 Important safety information: . . . . . . . . . . . . . . . . . . . .88
9.2 Daily cleaning and inspection . . . . . . . . . . . . . . . . . . . .89
9.3 Weekly checks and maintenance . . . . . . . . . . . . . . . . .90
9.4 Additional accessories . . . . . . . . . . . . . . . . . . . . . . . . .90
9.5 Consumable items . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
9.6 Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
9.7 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
9.8 Servicing by STERIS . . . . . . . . . . . . . . . . . . . . . . . . . .91

9.1 Important safety information:

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

9.2 Daily cleaning and inspection

1. Make sure there is sufficient chemical in chemical enclosure for planned wash
cycles.
2. Open lid and make sure lid seal is clean and undamaged.
3. Make sure basket is clean and undamaged.
4. Inspect filter and clean if clogged.
5. With clean cloth and disinfectant, wipe following;
5.1. All internal surfaces of tank if tank empty, otherwise all exposed internal
surfaces above water level.
5.2. All surfaces of lid.
5.3. All external surfaces of unit.
6. Wipe all external surfaces, including sides of lid.
7. With clean wet cloth, remove any trace of disinfectant from internal and external
surfaces of unit and lid.
8. Cleaning performance should be tested each day unit is used, and all test results
recorded.

9.3 Weekly checks and maintenance

1. Perform all daily checks and maintenance.
2. Make sure mains power cable is not trapped, or damaged.
3. Inspect drainage connections and hose for leaks, kinks, or damage.
4. Perform a Full Decontamination, see 10.1: Performing full decontamination

(page 93).
9.4 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 continued and reliable operation of your unit.

replacement parts may cause damage to unit and could void
both your warranty and guarantee of performance
Caution
9.5 Consumable items

1C3308 Prolystica 2X enzymatic pre-soak and cleaner (4 x 1 gallon)
1C3310 Prolystica 2X enzymatic pre-soak and cleaner (2.5 gallons)
1C2210 Prolystica HP Automated/Manual Washing Enzymatic

9.6 Replacement Parts

MP22845 Unity basket and hose set
MP22662 Chemical intake pipe
HOSE002 Water inlet hose with blue indicator
HOSE007 Water inlet hose, stainless steel
HOSE010 Reinforced PVC hose 50mm ID x 1 m long
MED3020 Gray drain hose
SWITCH006 Access panel key
MP22521 Filter
9.7 Accessories
MP22716 Standard hose and luer (pack of 8)
MP22683 ‘Y’ connector hose and luer (pack of 8)
Hoses and luers are compatible with Si/S (MP22716) and Xi (MP22683) robotic
instruments.
Image 9.1: Connecting S/Si Robotic Image 9.2: Connecting Xi Robotic

Instruments (MP22716) Instruments (MP22683)
9.8 Servicing by STERIS

This product should be serviced according to the service schedule described in
12.1 Maintaining servicing history (page 105). Servicing should only be performed by a
STERIS service technician.


10 Full Decontamination
Full Decontamination is defined as thorough cleaning and disinfection of the unit
and is vital to ensure unit is safe for operators and maintenance personnel.
Full decontamination should be done as part of weekly user maintenance,

and whenever unit has been idle for more than seven days.
Full Decontamination MUST be done if returning unit to STERIS.
10.1 Performing full decontamination

1. Perform daily cleaning procedure, 9.2: Daily cleaning and inspection
(page 89).
2. Put luer hoses on all basket flush ports.
3. Make disinfectant solution of 5% non-foaming Sodium Hypochlorite

disinfectant (see table below). Pour this solution into shallow heat-resistant
container (this prevents it from being drained at start of cycle). Put container in
basket.
Table 10.1: Sodium Hypochlorite volume conversion
Volume required for InnoWave™ Unity

Disinfection solution
tank
5% of non-foaming Sodium Hypochlorite 5% is equivalent to 1180 ml (40 fl.oz)
4. On display, select Decontamination wash program.
The unit is shipped with factory-set decontamination wash program (program

number 6 on wash cycle selection). A user-definable decontamination can be
setup using Supervisor Menu if required.
5. Put basket in tank.
6. Allow wash cycle to complete.
7. If preparing unit for shipping, fill out STERIS Decontamination Certificate. See
.

10.2 Decontamination certificate

Before any item is returned to your supplier or STERIS, a Full Decontamination MUST
be performed. In addition a Decontamination Certificate MUST be attached to the
outside of packing crate. If the Decontamination Certificate is not visible, the courier
and/or the supplier can refuse to accept item(s).
DECONTAMINATION CERTIFICATE
I hereby certify that the unit referred to in this document by Model and
Serial Number, has been disinfected in accordance with hospital
procedure.
Model No.:
Serial No.:
Hospital:
Name:
Signature: Date:
Promoting a clean and safe service

11 Diagnosing Operation Errors

This section of the manual describes error messages that may be shown during
operation of the InnoWave™ Unity, common causes of errors, and operator corrective
actions.
If an error cannot be diagnosed and corrected, or a problem occurs which is not

described in this manual, please contact STERIS.

11.1 Understanding errors reported on display . . . . . . . . . 96
11.2 Problems encountered during operation. . . . . . . . . . . 99
11.3 Check Chemical warning . . . . . . . . . . . . . . . . . . . . . 101
11.4 Contacting STERIS. . . . . . . . . . . . . . . . . . . . . . . . . . 102
11.5 Preparing unit for transportation . . . . . . . . . . . . . . . . 103

11.1 Understanding errors reported on display

Use the table below to remedy errors reported on the display.
Table 11.1: Understanding error codes shown on display
Error
Error Message Probable cause(s) and remedy
Code
1 Mains power removed Mains supply to unit was interrupted during a cycle. Turn
unit back on any repeat cycle. If problem persists have
electrician or qualified technician inspect electrical
connection.
2 Chamber overflow Make sure drain is not blocked.

Make sure instruments are not blocking drain.
Make sure non-foaming chemical is being used.
Make sure water pressure is not too high.
3 Drain time-out Make sure filter is not clogged.

Make sure non-foaming chemical is being used.
4 Chamber temperature Repeat cycle.

sensor mismatch
5 Chamber fill time-out Make sure water inlet hoses are connected and not kinked
or blocked.
Make sure site water supply is on.
Check unit and water connections for leaks.
7 Temperature set point Repeat cycle.

not maintained
10 Chamber water level low Make sure non-foaming chemical is being used.
Inspect unit for leaks. If unit is leaking, call for service
engineer.
13 Chemical dosing Make sure sufficient chemical is present in chemical

enclosure.
Make sure chemical intake hose is fully inserted in
chemical bottle.
Prime chemical pump.
14 Chamber start Chamber has not cooled sufficiently since last wash.
temperature too high Make sure cold water supply is below +35 °C (+95 °F).
Make sure cold water inlet hose is connected and not
kinked or blocked.
Make sure site cold water supply is on.
Leave more time between washes to allow unit to cool
down.

Table 11.1: Understanding error codes shown on display (Continued)
Error
Code
15 Tank temperature out of Switch the unit off then on again.

range
16,17,18, Level sensor invalid Repeat cycle.

19
20 User aborted cycle Repeat cycle.
23 Temperature set point Make sure hot water inlet temperature is no more than
exceeded +80 °C (+176 °F). Reduce hot water flow rate at source if
too hot.
Make sure cold water inlet hose is connected and not
kinked or blocked.
Make sure cold water flow rate is sufficient.
Repeat cycle.
39, 40, 41 Sonic generator fault Switch the unit off, then on again.
42 Maximum cycle time Make sure hot and cold water inlet hoses are connected
expired and not kinked or blocked.
Make sure hot and cold water inlet flow rates are sufficient.
Make sure drain filter is not clogged.
Repeat cycle.
43 Sonic generator fault Switch the unit off, then on again.
44 Sonic cleaning water Inspect unit for leaks. If unit is leaking, call for service
level low engineer.
45, 46, 47 Sonic generator fault Switch unit off, then on again.
49 Micro-controller error Switch unit off, then on again.
50 Internal ambient Make sure room temperature is below +40 °C (+104 °F).
temperature too high Make sure cooling fan air intake is not blocked or
restricted.
Turn unit off and leave for 1 hour to cool down.
51 Level sensor invalid Repeat cycle.
52 Real-time clock read Switch unit off, then on again.

error
53 24V power supply Switch unit off, then on again.

voltage out-of-range
57, 58 Micro-controller error Switch unit off, then on again.

Table 11.1: Understanding error codes shown on display (Continued)
Error
Code
59 Unable to store cycle log Repeat cycle.

11.2 Problems encountered during operation

Use the table below to diagnose observed issues.
Table 11.2: Observed problems and probable causes
Observed problem Probable cause(s) and remedy
Unit does not power-up • Make sure electrical power is supplied to unit.
• Make sure main disconnect switch is in ON position.
• Facility power may be incorrect for unit. Check that facility power
meets unit requirements.
• If facility power is incorrect for unit, internal circuit breaker may
have tripped. Contact STERIS.
Instruments not clean • Make sure chemical used is recommended by STERIS and is
after wash cycle being used according to manufacturer instruction.
• Instruments may be excessively soiled or have been left soiled for
more than 2 hours.
• Basket may be overloaded. Do not load more than recommend
number of instruments for cleaning.
• Perform wash cycle without luer connection to bottom flush port.
This aids water circulation.
• Supply power may not be sufficient for correct unit performance.
Make sure supply power meets specified requirements.
Water leaking from lid • Make sure all instruments in basket are below water level, and no
area instruments are pointing towards lid.
• Inspect lid seal for damage. If damaged, seal will need to be
replaced by service technician.
Display shows “Please • Make sure lid is completely closed.

close lid” • Make sure instruments in basket are not preventing lid from
closing.
Instrument channels and • Make sure luer hoses are fully connected to flush port.
inside surfaces not • Make sure connections on luer hoses are firmly attached.
cleaned.
Unit not flushing • Make sure luer hoses are not split, ruptured, or kinked.
instruments sufficiently. • Make sure basket is fully docked in tank.
• Make sure filter is not clogged.
• Make sure instruments are not blocking drain.
• Perform wash cycle without luer connection to bottom flush port.
This aids water circulation.
• Facility power may be incorrect for unit. Check that facility power
meets unit requirements.

Table 11.2: Observed problems and probable causes
Observed problem Probable cause(s) and remedy
Excessive fill time • Make sure site water connections are sufficient and have
pressure above 2.0 bar (29 psi).
• Make sure water inlet hoses are not kinked or constricted.
• Make sure water inlets are not blocked.

11.3 Check Chemical warning

During wash cycle if unit detects a problem with chemical delivery to tank, a warning
is displayed on screen (Image 11.1).
1. Check chemical bottle. Make sure there is sufficient chemical in bottle and
replace bottle if insufficient chemical.
2. Make sure chemical intake hose is fully inserted in chemical bottle.
3. Make sure chemical intake hose is not kinked or blocked between connections to
chemical bottle and chemical connector on unit.
4. Touch OK on screen after making sure chemical bottle and chemical intake hose
are in satisfactory condition. Wash program resumes.
Image 11.1: Check Chemical screen

11.4 Contacting STERIS

If performance issue or error cannot be diagnosed, call STERIS. Service charges may
be incurred dependent on your warranty cover. STERIS will schedule service
technician visit to diagnose and remedy any system performance issues.
Never permit unqualified persons to service system. Any
attempt at servicing by anyone other than STERIS service

technician will void your warranty and may result in charges to
Note remedy authorised servicing damage.
Calling for Service: First, investigate issue using diagnostic tables in Table 11.1 on
page 96 and Table 11.2 on page 99 and follow any recommended remedy actions. If
issue persists and cannot be remedied, call STERIS and provide following information:
• Full description of fault

• Model number
• Serial number
11.4.1 STERIS contact details
USA
(Sales, Customer Service & Technical Support)
STERIS
5960 Heisley Road
Mentor, OH 44060
Tel: 001-800-548-4873
www.steris.com

11.5 Preparing unit for transportation

In the unlikely event of unit needing to be returned to STERIS for any reason, the
following procedure must be carried out:
1. Perform Full Decontamination irrespective of when it was last cleaned. See

10.1: Performing full decontamination (page 93).
If unit cannot be run prior to return, tank/chamber must be

decontaminated by hand.
Note
2. Drain and completely empty machine of all fluids.
3. Remove all external hoses.
4. Complete a STERIS Decontamination Certificate. See 10.1: Performing full

decontamination (page 93)
5. Attach Decontamination Certificate to outside of packaging used to ship unit.
If Decontamination Certificate is not visible on outside of

shipping crate, courier and/or supplier CAN REFUSE to
accept item(s).
Note


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

STERIS recommend your InnoWave™ Unity is serviced every 6 months in
accordance with schedule contained within InnoWave™ Unity Service Manual. The
table below must be completed by technician conducting service and should be
made available in event of warranty claim, or breakdown repair.
InnoWave™ Unity User Manual 105 Service History

12 Service History
12.2 Service history record
6-Month Service 12-Month Service
Serviced by Initials & Date Serviced by Initials & Date
Cycles since last service Number of cycles Cycles since last service Number of cycles
Next service due Cycles & Date Next service due Cycles & Date
18-Month Service 2-Year Service
2.5-Year Service 3-Year Service
InnoWave™ Unity User Manual 106 Service History

13 Operator Authorization
This is an optional feature, which can be enabled by STERIS service technician. When
enabled, operator is required to enter four-digit PIN number to unlock user control
panel.
A valid PIN entry identifies user and their operator number is shown on data export.
13.1 Operator authorization codes

There are 80 operator numbers each with unique PIN number.
Table 13.1: Operator authorization (PIN) 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 2263 24 4383 44 6323 64 8343
5 2484 25 4424 45 6444 65 8464
6 2545 26 4565 46 6585 66 8525
7 2626 27 4646 47 6666 67 8686
8 2727 28 4747 48 6776 68 8787
9 2848 29 4868 49 6888 69 8828
10 2989 30 4929 50 6949 70 8969
11 3070 31 5090 51 7030 71 9050
12 3171 32 5191 52 7131 72 9151
13 3292 33 5232 53 7252 73 9272
14 3353 34 5373 54 7393 74 9333
15 3434 35 5454 55 7474 75 9494
16 3535 36 5555 56 7575 76 9995
17 3656 37 5676 57 7696 77 9636
18 3797 38 5737 58 7757 78 9777
19 3878 39 5898 59 7838 79 9858
20 3979 40 5999 60 7939 80 9959
InnoWave™ Unity User Manual 107 Operator Authorization

13 Operator Authorization
InnoWave™ Unity User Manual 108 Operator Authorization

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Revision Date Summary

1 02 May 2019 First release

COPYRIGHT © 2019 STERIS. ALL RIGHTS RESERVED.

LIMITED RIGHTS NOTICE TECHNICAL DOCUMENTATION/DATA:

DOC09889-EN i Revision history

InnoWave™ Unity User Manual ii Table of Contents

InnoWave™ Unity User Manual iii Table of Contents

5– Preparing for Wash

6– Wash Cycle Operation

InnoWave™ Unity User Manual iv Table of Contents

6.4 On completion of wash cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69

8– Downloading Wash Cycle Logs

InnoWave™ Unity User Manual v Table of Contents

11 – Diagnosing Operation Errors

InnoWave™ Unity User Manual vi Table of Contents

InnoWave™ Unity User Manual vii Safety Information

WARNING - Chemical burn and/or

InnoWave™ Unity User Manual viii Safety Information

CAUTION - Chemicals CAUTION - Equipment damage

InnoWave™ Unity User Manual ix Safety Information

FCC Declaration of Conformity

Protective earth symbol

Standard hazard label

Standard electrical danger label

InnoWave™ Unity User Manual x Safety Information

Contents of this chapter

1.1 Intended use of equipment . . . . . . . . . . . . . . . . . . . . . . 2

InnoWave™ Unity User Manual 1 General Information

1.1 Intended use of equipment

1.2 Equipment description

InnoWave™ Unity User Manual 2 General Information

1.3 Additional accessories

Using non-recommended chemicals, accessories, and

InnoWave™ Unity User Manual 3 General Information

1.4 Equipment identification

InnoWave™ Unity User Manual 4 General Information

1.5 Manufacturer information

STERIS Ireland Limited

InnoWave™ Unity User Manual 5 General Information

1.6 Applied standards

UL 61010-1:2015 Safety requirements for electrical equipment for measurement,

CAN/CSA-C22.2 Safety requirements for electrical equipment for measurement,

IEC 61010-1:2015 Safety requirements for electrical equipment for measurement,

IEC 61010-2-040:2015 Particular requirements for sterilizers and washer-disinfectors used to

ANSI/AAMI Washer-disinfectors — Part 1: General requirements, terms and

ISO 13485:2012 Medical devices - Quality management systems.

ISO 14971:2012 Medical devices - Application of risk management to medical devices.

ISO 15883-1:2006/Amd Washer-disinfectors. General requirements, terms and definitions and

ISO 16142-1:2016 Medical devices -- Recognized essential principles of safety and

BS EN Medical device software. Software life-cycle processes.

CISPR Industrial, scientific and medical equipment - Radio-frequency

PD IEC/TR 60878:2015 Graphical symbols for electrical equipment in medical practice.

PD 5304:2014 Guidance on the safe use of machinery.

InnoWave™ Unity User Manual 6 General Information

1.8 RoHS requirements

1.9 Disposal of unit

InnoWave™ Unity User Manual 7 General Information

InnoWave™ Unity User Manual 8 General Information

Contents of this chapter