W&H Lara RIL-117 User manual

RIL-117 RIL-122
Instructions for use
RIL-1 - ENG - Rev04

Table of contents
LARA| Instructions for use |RIL-1 ENG Rev04 |28/02/2019 |© 2019 W&H Sterilization Srl iii
Conformity 5
Symbols and messages 6
Introduction 7
About this manual 7
Use restrictions 8
Safety information 9
Safety warnings 9
Responsibility 10
Getting started 11
Unpacking 11
Handling 13
Product description 14
Installing the sterilizer 19
Operating with the sterilizer 21
User interface menu 23
Sterilizer setup 29
User authentication (optional) 31
USB pen drive 32
Standby mode 33
Administrator 35
User management (optional) 35
Traceability options (optional) 38
Managing printers 39
Printer selection (optional) 39
Label printer selection (optional) 39
Label printer usage (optional) 41
Label content description 44
Sterilizer tests 45
Sterilizer performance tests 45
Bowie and Dick test 45
Helix test 49
Vacuum test 52
Sterilization cycles 54
Load maintenance and preparation 54
Prepare the sterilizer 56
Sterilization cycle description 57
Sterilization cycle management 58
Unloading 65
Sterilization cycle report 65
Maintenance 72
Warnings for maintenance operations 72
Ordinary maintenance 73
Monthly or 50-cycle maintenance 75
400-cycle maintenance 80
800-cycle or biannual maintenance 83
800-cycle maintenance 89

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4000 cycle or five-year maintenance 91
Extraordinary maintenance 92
Battery-operated door opening tool 96
Disposal 99
Diagnostic 100
Errors 100
Troubleshooting 106
Technical data 111
Sterilization cycles 111
Sterilization cycle phases 115
Technical data 118
Recommendations for validation 120
Diagrams 121
Water quality 122
Accessories, spare parts, consumables 123
Authorized W&H service partners 128
Documentation forms 131
W&H installation check-list 131
Helix test documentation form 134

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Conformity
CONFORMITY TO EUROPEAN STANDARDS AND DIRECTIVES
STERILIZER featuring sterilization cycles conform with the following
standards:
Standards
and
Directives
Description
93/42/EEC
Medical Device Directive (MDD).
Medical Device Directive 93/42/EEC for devices class IIb, in
accordance with the Rule 15 – ANNEX IX of the above Directive.
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 (WEEE).
EN 13060 Small 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: LARA sterilizers can be validated in accordance to EN17665-1.
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.
Consult the Instructions
for use.
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.

Introduction
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CONTENTS
This section deals with the following subjects:
About this manual 7
Use restrictions 8
About this manual
INTRODUCTION
This manual contains the Instructions for use of the W&H sterilizers
RIL-117 and RIL-122, hereinafter referred to as LARA 17 and
LARA22.
FOR YOUR SAFETY AND THE SAFETY OF YOUR PATIENTS
The purpose of this manual is to provide information about LARA
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9).
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:
nRIL-117
nRIL-122
Versions differ only for the chamber volume.
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
[e-mail].

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Introduction
COPYRIGHT NOTICE
Copyright © 2019, 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.
The information contained in this document is subject to change
without prior notice.
Use restrictions
INTENDED USE
LARA sterilizers are widely used for medical purposes, e.g. in
general medical practices, dentistry, facilities for personal hygiene
and beauty care and also veterinary practices. They are also used
for materials and equipment that is likely to be exposed to blood or
body fluids, e.g. implements used by beauty therapists, tattooists,
body piercers and hairdressers.
The types of loads that can be sterilized with LARA sterilizers are
described in Table 1 of the reference technical norm EN 13060.
These loads include solid, porous, hollow loads type A and hollow
loads type B, unwrapped, single wrapped and double wrapped.
LARA sterilizers cannot be used to sterilize liquids or
pharmaceutical products. The device is intended for professional
use only by trained people.
PROVIDED FEATURES
See "Sterilization cycles" on page111 for the full list of key program
features, including sterilization time, temperature 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 9
Responsibility 10
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 "Sterilization
cycle management" on page58).
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.
nIf the sterilizer is connected to a water supply
system, this must be fitted with a backflow
preventing device complying to IEC 61770.
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 11
Handling 13
Product description 14
Installing the sterilizer 19
Operating with the sterilizer 21
User interface menu 23
Sterilizer setup 29
User authentication (optional) 31
USB pen drive 32
Standby mode 33
Unpacking
UNPACK THE STERILIZER
CAUTION! Heavy product. The sterilizer must be removed
from the box and transported by two authorized technicians.
The sterilizer must be removed from the box and
transported using the specific straps.
Weight:
nLARA 17: 42.5 kg (93.7 lbs)
nLARA22: 44 kg (97 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 (three)
Reversible rack Tray holder
Mains cable Drain tube

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Getting started
USB pen drive This manual, declaration of
conformity, documentation CD,
warranty card, work test report,
maintenance sheet
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 l (1.3 gal))
nLAN cable for connecting the sterilizer to a network (optional)
See "Accessories, spare parts, consumables" on page123 for a full
list of optional accessories.
Handling
HOW TO RELOCATE THE STERILIZER
Before transport:
nCompletely drain both water tanks (see "Draining the used and
clean water tank" on page92).
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
BTank filling cover-cap
CWater tank cover
DTouch screen
EService door
FSterilization chamber
GDust filter
HReset button of the thermostat switch
IDoor seal
LDoor pin

Getting started
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UPPER INTERNAL STRUCTURE
Part Description
ATank
BWater level sensor
CWater tank cover
DInternal tank cover
ETank internal filters with metal cartridges

Getting started
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COMPONENTS BEHIND THE SERVICE DOOR
Part Description
ABacteriological filter
BMains switch
CIdentification label
DUsed water drain port (grey)
EClean water drain port (blue)
FDrain tube release button
GUSB port

Getting started
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REAR VIEW
Part Description
AUSB port (optional)
BAir gap cover
CTest connection
DPressure safety valve cover
EUsed water drain
FWater supply inlet
GCondenser grid
HMains cable guide
IMains cable plug socket

Getting started
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CHAMBER ACCESSORIES
Part Description
ATray
BChamber rack.
nIn the normal position, it can host 5 trays horizontally or 3
cassettes/containers vertically.
nIn a 90° degrees rotated position, it can host 3 trays or 3
cassettes/containers horizontally.

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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 supply plug.
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 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:
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:
Use only the cord set provided by the manufacturer.
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.

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Getting started
The electrical power supply of the sterilizer must fulfill all applicable
standards in the country of use, and must comply with the data
label on the back of the sterilizer.
WATER CONNECTIONS
The sterilizer clean water tank can be filled manually by the user or
automatically with a water supply system. The water supply
system must deliver demineralized or distilled water meeting the
specifications listed in these instructions. Do not add any
chemical/additive to the water.
The manufacturer’s warranty is void if the sterilizer was used with
water containing either chemical additives, or contaminant levels
exceeding those listed in these instructions. See "Feed water
specifications (EN 13060)" on page122.
Notice: The maintenance of the external water filling system must
be done in exact accordance with the Instructions for use given with
the relevant system.
WI-FI CONNECTION
For the Wi-Fi connection proceed as follows:
1Insert the Wi-Fi key in the USB port.
2Read the Instructions for use provided with the Wi-Fi key.
INSTALLING THE STERILIZER
WARNING! In case of sterilizer malfunctions immediately
unplug the sterilizer and call for service. Do not attempt to
repair the sterilizer yourself.
Notice:
Please refer to technical requirements before to plug the sterilizer!
See "Diagrams" on page121.
No other devices should be connected to the sterilizer power panel
circuit.
1Place the sterilizer on a resistant, flat and level surface.
2Open the chamber door, remove all items except the chamber
rack from the sterilizer and close.
3Remove all the plastic covers from the items.
4Optional. Connect the used and clean water tubes on the rear.
5Plug the power cord into the socket in the back of the
sterilizer.
6Place the power cord in the power cord guides.
7Connect the power cord to a wall outlet. For power supply
requirements, see "Technical data" on page118.