W&H Lyla User manual

RIN-210-17 RIN-210-22
Instructions for Use
RIN-210 - ENG - Rev02

Table of contents
Lyla| Instructions for Use |RIN-210 ENG Rev02 |15/09/2022 |© 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 13
Unpacking 13
Handling 15
Product description 17
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 32
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 38
Sterilizer tests 39
Sterilizer performance tests 39
Bowie and Dick test 39
Helix test 43
Vacuum test 45
Sterilization cycles 47
Load maintenance and preparation 47
Prepare the sterilizer 49
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 93
Technical data 96
Sterilization cycles 96
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
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 moduleD1 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: Lyla 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
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 or model
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
RIN-210-17 and RIN-210-22, hereinafter referred to as Lyla 17 and
Lyla 22.
FOR YOUR SAFETY AND THE SAFETY OF YOUR PATIENTS
The purpose of this manual is to provide information about Lyla
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:
nRIN-210-17
nRIN-210-22
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
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.
PROVIDED FEATURES
See "Sterilization cycles" on page96 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
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 encrypted 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.
Responsibility
USER RESPONSIBILITY
nThe user is responsible for the proper installation, the correct
use and maintenance of the sterilizer in accordance with these

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Safety information
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 13
Handling 15
Product description 17
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 32
Unpacking
UNPACK THE STERILIZER
CAUTION! Heavy product. The sterilizer must be removed
from the box and transported by two authorized technicians.
Weight:
nLyla 17: 41.5 kg (91.5 lbs)
nLyla 22: 43.5 kg (95.9 lbs)

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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)
Emergency door opening tool Reversible rack

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Getting started
Tray holder Mains cable
Drain tube 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" 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80)
nAllow the sterilization chamber to cool down

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Getting started
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 AND UPPER INTERNAL STRUCTURE
Part Description
AChamber door
BTank
CWater level sensor
DWater tank cover
ETank filling cover-cap
FWater tank cover
GInternal tank cover
HTank internal filters with metal cartridges
ITouch screen
LService door
MSterilization chamber
NDust filter
OReset button of the thermostat switch
PEmergency door opening tool
QDoor seal
RDoor pin

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 (optional)
FWater supply inlet (optional)
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.