W&H Lara RIS-311 User manual

RIS-311
Instructions for Use
RIS-311 - ENG - Rev02

Table of contents
Lara XL| Instructions for Use |RIS-311 ENG Rev02 |01/06/2022 |© W&H Sterilization Srl iii
Conformity 5
Symbols and messages 6
Introduction 8
About this manual 8
Use restrictions 9
Safety information 10
Safety warnings 10
Responsibility 11
Getting started 12
Unpacking 12
Handling 15
Product description 16
Installing the sterilizer 20
Operating the sterilizer 24
User interface menu 25
Sterilizer setup 30
User authentication 31
EliTrace (optional) 32
USB pen drive 32
Standby mode 32
Administrator 34
User management 34
Traceability options 35
Hide/Unhide a cycle 35
Managing printers 37
Printer selection (optional) 37
Label printer selection (optional) 37
Label printer usage (optional) 38
Label content description 40
Sterilizer tests 41
Sterilizer performance tests 41
Bowie and Dick test 41
Helix test 45
Vacuum test 47
Sterilization cycles 49
Load maintenance and preparation 49
Prepare the sterilizer 51
Sterilization cycle description 52
Sterilization cycle management 53
Unloading 58
Sterilization cycle report 58
Maintenance 63
Warnings for maintenance operations 63
Ordinary maintenance 64
Monthly or 50-cycle maintenance 66
400-cycle maintenance 69

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800-cycle or biannual maintenance 70
800-cycle maintenance 73
4000 cycle or five-year maintenance 75
Extraordinary maintenance 76
Disposal 77
Diagnostics 78
Errors 78
Troubleshooting 83
Emergency door opening 88
Technical data 91
Sterilization cycles 91
Sterilization cycle phases 96
Technical data 99
Recommendations for validation 100
Diagrams 101
Water quality 102
Accessories, spare parts, consumables 103
Authorized W&H service partners 105
Documentation forms 106
W&H installation check-list 106

Conformity
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CONFORMITY TO EUROPEAN 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).
EN 13060 Small steam sterilizers.
IEC 61010-1 Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
Standards
and
Directives
Description
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: Lara XL sterilizers can be validated in accordance to EN ISO 17665-1.
Note: Every new sterilizer is delivered with a Declaration of Conformity and a
Warranty Card.

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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 only
distilled or
demineralized water.
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 Lara XL
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10).
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.
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 10
Responsibility 11
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53).
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
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
In order to improve the IT security of the system, a firewall (iptables)
is installed in the system and protects the security of the device
from external attacks.
It is recommended not to leave the machine unattended.
Note: a list of security information is mentioned in the MDS2 document,
which is available on request.
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 12
Handling 15
Product description 16
Installing the sterilizer 20
Operating the sterilizer 24
User interface menu 25
Sterilizer setup 30
User authentication 31
EliTrace (optional) 32
USB pen drive 32
Standby mode 32
Unpacking
UNPACK THE STERILIZER
CAUTION! Heavy product. The sterilizer must be removed
from the box and transported by two authorized technicians.
Weight: 60.7 kg (133.8 lbs)

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Getting started
WARNINGS
Notice: check the external condition 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 (four + 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 5.5 l (1.45 gal))
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76)
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
HBacteriological 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

Getting started
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REAR VIEW
Part Description
ALAN port
BUSB ports
CPressure safety valve cover
DUsed water drain
EWater supply inlet
FCondenser grid
GPower cord guides
HPower cord socket

Getting started
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CHAMBER ACCESSORIES
Part Description
ATray
BChamber rack. It can host trays or cassettes inserted horizontally or
vertically.

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Getting started
Installing the sterilizer
LOCATION REQUIREMENTS
Notice:
Do not place the sterilizer so that it is difficult to operate the controls
behind the service door. Do not place the sterilizer so that it is
difficult to disconnect the power cord.
Leave the condenser grid (rear side of the sterilizer) free from
anything that might obstruct the air passage.
Surface materials should be water resistant. If sterilization cycles
will be continuous, pay attention to the surrounding materials: steam
can damage them.
The sterilizer must operate in absence of explosive atmospheres.
The sterilizer must operate in a well ventilated room (indoor), far
from sources of heat and from flammable materials.
Place the sterilizer on a flat and level surface.
Clearance requirements to ensure proper air circulation:
Make sure that the clean water tank can be easily accessed for
periodic cleaning operations.
ELECTRICAL CONNECTIONS
All the cables and tubes connected on the rear side of the sterilizer
must be placed far from the condenser grid (e.g. using the available
guides).
Notice:
Connect the sterilizer to a dedicated line. Do not use cable
extensions nor multiple sockets/adapters.
Ensure that external and internal surfaces are free from moisture or
condensation before connecting to power.
The installation of the sterilizer shall be performed by two authorized
technicians using PPE (Personal Protective Equipment) according to
applicable standards.