W&H Med Lara User manual

RIL-117 RIL-122
Instructions for Use
RIL-1 W&H Med - ENG - Rev06

Table of contents
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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 21
Operating the sterilizer 23
User interface menu 24
Sterilizer setup 30
User authentication (optional) 31
USB pen drive 32
Standby mode 33
Administrator 34
User management (optional) 34
Traceability options (optional) 35
Managing printers 36
Printer selection (optional) 36
Label printer selection (optional) 36
Label printer usage (optional) 37
Label content description 39
Sterilizer tests 40
Sterilizer performance tests 40
Bowie and Dick test 40
Helix test 44
Vacuum test 46
Sterilization cycles 48
Load maintenance and preparation 48
Prepare the sterilizer 50
Sterilization cycle description 50
Sterilization cycle management 51
Unloading 55
Sterilization cycle report 55
Maintenance 60
Warnings for maintenance operations 60
Ordinary maintenance 61
Monthly or 50-cycle maintenance 63
400-cycle maintenance 68
800-cycle or biannual maintenance 71
800-cycle maintenance 77

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4000 cycle or five-year maintenance 79
Extraordinary maintenance 80
Disposal 81
Diagnostics 82
Errors 82
Troubleshooting 87
Emergency door opening 94
Technical data 97
Sterilization cycles 97
Sterilization cycle phases 102
Technical data 105
Recommendations for validation 107
Diagrams 108
Water quality 109
Accessories, spare parts, consumables 110
Authorized W&H service partners 115
Documentation forms 116
W&H installation check-list 116
Helix test documentation form 119

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
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 Directive (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.
Standards
and
Directives
Description
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 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.

Temperature between XX °C
and XX °C.
Manufacturing date (YYYY-
MM-DD).
Manufacturer.
Unique Device Identification.
Health industry bar code in
accordance with HIBC
Standard.
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.
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
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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:
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
[email protected].

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Introduction
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.
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97 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 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 "Sterilization
cycle management" on page51).
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 med.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 21
Operating the sterilizer 23
User interface menu 24
Sterilizer setup 30
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.
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

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Getting started
Mains cable 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, 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110 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80)
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 gasket
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
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.