W&H Lexa PLUS User manual

RIS-311
Instructions for Use
RIS-311 - ENG - Rev03

Table of contents
Lexa PLUS| Instructions for Use |RIS-311 ENG Rev03 |29/08/2022 |© W&H Sterilization Srl iii
Conformity 5
Symbols and messages 6
Introduction 8
About this manual 8
Use restrictions 9
Safety information 12
Safety warnings 12
Responsibility 14
Getting started 15
Unpacking 15
Handling 18
Product description 19
Installing the sterilizer 23
Operating the sterilizer 27
User interface menu 28
Sterilizer setup 34
User authentication (optional) 35
EliTrace (optional) 36
USB pen drive 36
Standby mode 37
Administrator 38
User management (optional) 38
Traceability options (optional) 39
Hide/Unhide a cycle 40
Managing printers 41
Printer selection (optional) 41
Label printer selection (optional) 41
Label printer usage (optional) 42
Label content description 44
Sterilizer tests 45
Sterilizer performance tests 45
Bowie and Dick test 45
Vacuum test 47
Sterilization cycles 49
Load maintenance and preparation 49
Typical loads 51
Prepare the sterilizer 52
Sterilization cycle description 53
Sterilization cycle management 54
Unloading 59
Sterilization cycle report 59
Maintenance 64
Warnings for maintenance operations 64
User maintenance 64
Monthly or 50-cycle maintenance 66
400-cycle maintenance 69

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800-cycle or biannual maintenance 70
1200-cycle or yearly maintenance 73
Extraordinary maintenance 75
Disposal 76
Diagnostics 77
Errors 77
Troubleshooting 82
Emergency door opening 87
Technical data 90
Sterilization programs 90
Sterilization cycle phases 93
Technical data 97
Recommendations for validation 98
Diagrams 99
Water quality 100
Accessories, spare parts, consumables 102
Authorized W&H service partners 104
Documentation forms 105
W&H installation check-list 105

Conformity
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CONFORMITY TO EUROPEAN AND AMERICAN REGULATIONS,
STANDARDS AND DIRECTIVES
Sterilizer conforms with the following Regulations, Standards and
Directives:
Standards
and
Directives
Description
Medical Device Regulation (MDR).
Regulation (UE) n. 2017/745 for medical devices. Class IIb
devices, in accordance with the Rule 16 – ANNEX VIII of the above
Regulation.
For Device in compliance with Machinery Directive (2006/42/EC),
Low Voltage Directive (2014/35/EU) and Electomagnetic
Compatibility Directive (2014/30/EU).
2014/68/EU
Pressure Equipment Directive (PED).
Directive 2014/68/EU (PED – Pressure Equipment Directive) for
every sterilization chamber designed and manufactured in
conformity to the ANNEX 1 and to the procedure described in the
module D1 Annex III.
2012/19/EU Waste Electrical and Electronic Equipment Directive (WEEE).
CSA C22.2 No.
61010-1
Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
UL 61010-1 Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
Standards
and
Directives
Description
ASME Boiler and pressure vessel code.
EN 13060 Small steam sterilizers.
ANSI/AAMI
ST55
Table-top steam sterilizers.
IEC 61010-1 Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
IEC 61010-2-
040
Safety requirements for electrical equipment for measurement,
control and laboratory use; particular requirements for sterilizers
and washer-disinfectors used to treat medical materials.
IEC 61326-1 Electrical equipment for measurement, control and laboratory use
- EMC requirements; general requirements.
IEC 61770 Electric appliances connected to the water mains - Avoidance of
backsiphonage and failure of hose-sets.
Note: Every new sterilizer is delivered with a Declaration of Conformity and a
Warranty Card.

6 Lexa PLUS| Instructions for Use |RIS-311 ENG Rev03 |29/08/2022 |© W&H Sterilization Srl
Symbols and messages
SAFETY SYMBOLS USED IN THIS MANUAL
WARNING: Indicates a hazardous situation that, if not avoided, could
result in death or serious injury.
Related to a sterilizer, these warnings indicate hazardous situations
that could result in non-sterile conditions (e.g. non-sterile instruments)
which could lead to fatal personal injury.
CAUTION: Indicates a hazardous situation that, if not avoided, could
result in minor or moderate injury.
SYMBOLS DISPLAYED ON THE PRODUCT
Hot surfaces!
Risk of burns.
Hot steam!
Risk of burns.
Consult the
Instructions for Use
for important
cautionary
information.
Don't use drinking
water to fill the clean
water tank; use
distilled or
demineralized water
only.
Consult the
Instructions for Use.
Disposal / Do not
dispose of with normal
waste
PROPERTY DAMAGE MESSAGES
Notice: Indicates information considered important, but not hazard-related. Typically to avoid damage to the product.

Storage.
Transportation.
Medical Device.
Only for MDR devices.
Serial Number.
Catalogue number.
Max. pressure / Max.
allowable working pressure
(MAWP).
Temperature between XX °C
and XX °C.
Manufacturing date (YYYY-
MM-DD).
Country of manufacture.
Manufacturer.
Unique Device
Identification.
Health industry bar code in
accordance with HIBC
Standard.
Small Steam Sterilizer.
This side up.
Fragile, handle with care.
Keep dry.
The sterilizer must be
transported by two
authorized technicians due
to its heavy weight.
ON (supply) IEC 60417-
5007.
OFF (supply) IEC 60417-
5008.
IN-position of bistable push
control IEC 60417-5268.
OUT- position of bistable
push control IEC 60417-
5269.
USB connection.
GS1 datamatrix for logistic
purpose.
Sterilizer type.
Test connection.
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Introduction
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CONTENTS
This section deals with the following subjects:
About this manual 8
Use restrictions 9
About this manual
FOR YOUR SAFETY AND THE SAFETY OF YOUR PATIENTS
The purpose of this manual is to provide information about Lexa
PLUS sterilizers to ensure:
nproper installation and set-up
noptimal use
nsafe and reliable operation
ncompliance with regular maintenance and servicing
requirements
Please carefully read the safety information (see "Safety warnings"
on page12).
OBLIGATIONS WITH REGARD TO THIS MANUAL
This manual is an integral part of the product and accompanies it for
its entire working life. It must be consulted in all situations related to
the life cycle of the product, from its delivery through to
decommissioning. For this reason, it should always be accessible to
operators both online and offline.
Contact customer service in the event the manual is unavailable. If
the device is transferred, always attach the manual for the new
owner.
MANUAL CONTENT
This manual contains the Instructions for Use and for maintenance
of the following sterilizer versions:
This manual contains the Instructions for Use and for maintenance
of the following sterilizer version:
nRIS-311 200–240 V ac
DISCLAIMER
All pictures, graphics and illustrations provided in this manual are for
the comprehension of the text. They are not meant to be an accurate
representation of product details. Thus, they should be taken as
indicative only, and may differ from the actual product.
For any suggestions or remarks please send an email to
[email protected].
COPYRIGHT NOTICE
Copyright ©, W&H Sterilization Srl
All rights reserved in all countries.
All drawings, images and texts contained in this manual are the
property of the manufacturer. Even partial duplication of drawings,
images or text is prohibited.

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Introduction
The information contained in this document is subject to change
without prior notice.
Use restrictions
INTENDED USE
For Medical Device in accordance with Regulation EU 2017/745:
The small steam sterilizers are intended for the sterilization of
invasive and non-invasive medical devices. The devices are
intended for professional use by trained people only.
For other purposes out of the scope of Regulation EU 2017/745:
The small steam sterilizers are intended for the sterilization of
devices other than invasive and non-invasive medical ones. The
small steam sterilizers are intended for the sterilization in veterinary
practices. They are also intended to be used for materials and
equipment which are likely to come into contact with blood or body
fluids, e.g. implements used by beauty therapists, tattooists, body
piercers and hairdressers.
The devices are intended for professional use by trained people
only.
For North American market:
Lexa PLUS is a dynamic-air-removal (pre-vacuum) table-top steam
sterilizer intended for use by a healthcare provider to sterilize
medical products by means of pressurized steam. It is suitable for
the sterilization of medical and dental instruments that are validated
to be sterilized by steam.
The Lexa PLUS has not been designed to sterilize liquid loads,
biomedical waste or materials not compatible with steam
sterilization. The processing of such loads may result in incomplete
sterilization and/or damage to the autoclave.

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Introduction
Key program features, including sterilization time, temperature and
recommended load type are listed in the following table: Program
Type of Load
and Load
weight
Sterilization
Temperature
Sterilization
Time
Drying Time
(recommended)
Wrapped Pouched
Instruments
and Dental
Handpieces
on trays 14
lbs (6.3 kg)
(trays
excluded).
Instruments
and dental
handpieces in
wrapped
cassettes or
in trays and
wrapped
cassettes
16.5 lbs (7.5
kg) (trays and
cassettes
included).
Pouched
Textile load
on trays 4.4
lbs (2.0 kg)
(trays
excluded).
270 °F
(132 °C)
4 minutes 22 minutes

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Introduction
Program
Type of Load
and Load
weight
Sterilization
Temperature
Sterilization
Time
Drying Time
(recommended)
Low
Temperature
Pouched
Instruments
(solid
instruments)
on trays 14
lbs (6.3 kg)
(trays
excluded).
Solid
instruments
in wrapped
cassettes or
in trays and
wrapped
cassettes
16.5 lbs (7.5
kg) (trays and
cassettes
included).
Pouched
Textile load
on trays 4.4
lbs (2.0 kg)
(trays
excluded).
250 °F
(121 °C)
30 minutes 28 minutes
Unwrapped Instruments
and dental
handpieces,
up to 18 lbs
(8.1 kg).
270 °F
(132 °C)
4 minutes 4 minutes
See "Sterilization programs" on page90 for the full list of key
program features, including sterilization time, temperature, drying
time and recommended load type.
USER QUALIFICATION
The users who may operate the sterilizer are the following.
User
qualification Competences
Head of the
clinic/practice
Legally responsible for:
nthe efficiency of the hygiene protocol in place
nthe sterilization process
nthe operators' training and training documentation
nthe correct operation and maintenance of the equipment
Trained
operators
nRegularly attend the training for operating and using the
sterilizer safely.
nUse the sterilizer according to the Head of the
clinic/practice's instructions.

Safety information
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CONTENTS
This section deals with the following subjects:
Safety warnings 12
Responsibility 14
Safety warnings
THERMAL HAZARDS
nThe chamber automatically begins to heat to
high temperature as soon as the sterilizer is
switched on – risk of burns!
nThe trays and the sterilization load are hot at
the end of each cycle. Use tray or cassette
holders to empty the sterilization chamber.
nAlways wear appropriate PPE during use of the
sterilizer (e.g. gloves for cleaning, maintenance,
etc...).
ELECTRICAL RISKS
nDo not pour water or any other liquids over the
sterilizer (risk of electrical short circuits).
nSwitch off the sterilizer and unplug the mains
cable before inspecting, carrying out
maintenance or servicing the sterilizer.
nEnsure that the power receptacle the sterilizer
is connected to is properly grounded.
nAll electric devices connected to the sterilizer
shall be of Insulation Class II (double insulated)
or higher.
nUse only the power cord provided by the
manufacturer.
IMPROPER USE OF THE STERILIZER
nThe sterilizer must not be used in presence of
explosive or flammable gases, vapors, liquids
or solids.
nThe sterilizer has not been designed for the
sterilization of foodstuff or waste.
nDo not exceed the maximum load weight limits
as specified in this manual (see "Run a
sterilization cycle" on page54).
nDo not drink any water that has been inside the
sterilizer.

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Safety information
TAMPERING
nDo not remove the name plate or labels from
the sterilizer.
nRepairs, maintenance or service must be
carried out by authorized service providers
always using genuine spare parts.
REQUIREMENTS
nAll accessories connected to the sterilizer shall
be FDA cleared.
nUse only the power cord set and accessories
provided by the manufacturer.
nSerious incidents that have occurred in relation
to this medical device should be reported to the
manufacturer and competent authority in the
country where the incident occurred.
nIn case of malfunction of the sterilizer, contact
an authorized technician or the manufacturer.
CYBER SECURITY
The device is designed in such a way that a cyber-attack or software
failure does not compromise the safety in relation to the intended
use. A successful cyber-attack cannot result in direct patient harm:
in fact, the device is not in contact with patients.
The device does not share any data (sensible and not sensible)
related to patients.
To further protect the device and minimize successful cyber-attacks,
the following precautions have been taken:
nthe access to the device operating system is not possible (user
access to the operating system is disabled);
na firewall is active on the device; all the device network
connections (to and from the external world) are managed by
the firewall which, following specific rules, filters them and
blocks everything that is not strictly necessary for the device;
nthe update/install operations are only possible using signed
and crypted software, provided by W&H;
nduring the normal use, the operating system and the
application (responsible for the device functionalities) are
located in a read-only memory, so to avoid intentional
corruption;
nall the sterilization data are secured by means of checksum
controls.
In order to minimize the possibility of cyber-attacks, it is user
responsibility to apply the following measures:
nsoftware update/install shall be done by authorized and trained
personnel only;
nit is recommended to activate a firewall on the router/modem
used for the internet connection.
Note: further security information is mentioned in the MDS2 document,
which is available on request.

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Safety information
Responsibility
USER RESPONSIBILITY
nThe user is responsible for the proper installation, the correct
use and maintenance of the sterilizer in accordance with these
Instructions for Use.
nThe safety devices of the sterilizer are impaired when the
product itself is not installed, used and serviced in accordance
with these Instructions for Use.
nThe Instructions for Use updated to the latest version is always
available at www.wh.com.
nKeep these Instructions for Use for future reference.
MANUFACTURER RESPONSIBILITY
nThe manufacturer can only accept responsibility for the safety,
reliability and performance of the product when the product
itself is installed, used and serviced in accordance with the
Instructions for Use.
nServicing by unauthorized persons invalidates all claims under
warranty and any other claims.

Getting started
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CONTENTS
This section deals with the following subjects:
Unpacking 15
Handling 18
Product description 19
Installing the sterilizer 23
Operating the sterilizer 27
User interface menu 28
Sterilizer setup 34
User authentication (optional) 35
EliTrace (optional) 36
USB pen drive 36
Standby mode 37
Unpacking
UNPACK THE STERILIZER
CAUTION! Heavy product. The sterilizer must be removed
from the box and transported by two authorized technicians.
Weight: 133.4 lbs (60.5 kg)

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Getting started
WARNINGS
Notice: check the external conditions of the box and the sterilizer. In
case of any damage, immediately contact the dealer or shipping
agent that has carried out the transport. Keep the packaging for
shipping or transporting the sterilizer in the future.
Note: The packaging of the product is environmentally friendly and can be
disposed of by industrial recycling companies.
CONTENTS OF THE PACKAGING
Sterilizer Trays (three + two)
Chamber rack Tray holder

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Getting started
Power cord Drain tube

Emergency door opening tool Tube for drain connection
USB pen drive loaded with
Instructions for Use
This manual, declaration of
conformity, warranty card, work
test report


ITEMS NOT PROVIDED WITH THE STERILIZER
The following items are not provided:
nWater container to capture waste water during manual tank
draining (volume larger than 1.45 gal (5.5 l))
nLAN cable for connecting the sterilizer to a network (optional)
See "Accessories, spare parts, consumables" for a full list of optional
accessories.

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Getting started
Handling
HOW TO RELOCATE THE STERILIZER
Before transport:
nCompletely drain both water tanks (see "Draining the used and
clean water tank" on page75)
nAllow the sterilization chamber to cool down
nUse original packaging when shipping or transporting the
sterilizer. Replacement packaging materials are available from
Service W&H

Getting started
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Product description
FRONT VIEW
Part Description
AChamber door
BClean water tank filling point
CDoor locking system
DTouch screen
EService door
FSterilization chamber
GSafety thermostat reset
HHEPA filter
IDoor gasket
JClean tank cover-cap
KClean water tank
LTank internal filter with metal cartridges

Getting started
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COMPONENTS BEHIND THE SERVICE DOOR
Part Description
AMains switch
BUSB port
CEmergency door opening tool
DIdentification label
EUsed water drain connection (grey)
FClean water drain connection (blue)
GDrain tube release buttons
HPort for emergency door opening tool