W&H Lara RIL-117, Lara RIL-122 Instructions For Use Manual

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Instructions for use

RIL-1 - ENG - Rev04

RIL-117 RIL-122

Table of contents

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

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

Conformity

CONFORMITY TO EUROPEAN STANDARDS AND DIRECTIVES

STERILIZER featuring sterilization cycles conform with the following standards:

Standards and Directives

93/42/EEC

2014/68/EU

2012/19/EU Waste Electrical and Electronic Equipment (WEEE).

EN 13060 Small steam sterilizers.

IEC 61010-1 Safety requirements for electricalequipment for measurement,

IEC 610102-040

IEC 61326-1 Electrical equipment for measurement, control and laboratory use -

IEC 61770 Electricappliances connected to the water mains - Avoidanceof

Description

Medical Device Directive (MDD). Medical Device Directive 93/42/EEC for devices class IIb, in

accordancewith the Rule 15 – ANNEX IX of the above Directive.

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.

control and laboratory use, general requirements.

Safety requirements for electrical equipment for measurement, control and laboratory use; particular requirements for sterilizers and washer-disinfectors used to treat medicalmaterials.

EMC requirements; general requirements.

backsiphonage and failureof hose-sets.

Note: Every new sterilizer is delivered with a Declaration of Conformity and a Warranty Card.

Note: LARA sterilizers can be validated in accordance to EN17665-1.

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

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.

FORYOUR SAFETY AND THE SAFETY OF YOUR PATIENTS

The purpose of this manual is to provide information about LARA sterilizers to ensure:

n proper installation and set-up; n optimal use; n safe and reliable operation; n compliance 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:

n RIL-117 n RIL-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 office.sterilization@wh.com.

Introduction

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

Head of the clinic/practice

Trained operators

Competences

Legallyresponsible for:

n the efficiencyof the hygiene protocol in place n the sterilization process n the operators' training and training documentation n the correct operation and maintenance of the equipment

n Regularly attend the training for operating and using the

sterilizer safely.

n Use the sterilizer according to the Head of the

clinic/practice's instructions.

Safety information

CONTENTS

This section deals with the following subjects:

Safety warnings 9 Responsibility 10

Safety warnings

THERMAL HAZARDS

n The chamber automatically begins to heat to

high temperature as soon as the sterilizer is switched on – risk of burns!

n The trays and the sterilization load are hot at the

end of each cycle. Use tray or cassette holders to empty the sterilization chamber.

n Always wear appropriate PPE during use of the

sterilizer (e.g. gloves for cleaning, maintenance, etc...).

ELECTRICAL RISKS

n Do not pour water or any other liquids over the

sterilizer (risk of electrical short circuits).

n Switch off the sterilizer and unplug the mains

cable before inspecting, carrying out maintenance or servicing the sterilizer.

n Ensure that the power receptacle the sterilizer is

connected to is properly grounded.

n All electric devices connected to the sterilizer

shall be of Insulation Class II (double insulated) or higher.

n Use only the power cord provided by the

manufacturer.

IMPROPER USE OF THE STERILIZER

n The sterilizer must not be used in presence of

explosive or flammable gases, vapors, liquids or solids.

n The sterilizer has not been designed for the

sterilization of foodstuff or waste.

n Do not exceed the maximum load weight limits

as specified in this manual (see "Sterilization cycle management" on page58).

n Do not drink any water that has been inside the

sterilizer.

Safety information

TAMPERING

n Do not remove the name plate or labels from the

sterilizer.

n Repairs, maintenance or service must be carried

out by authorized service providers always using genuine spare parts.

REQUIREMENTS

n Use only the power cord set and accessories

provided by the manufacturer.

n If 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

n The user is responsible for the proper installation, the correct

use and maintenance of the sterilizer in accordance with these Instructions for use.

n The safety devices of the sterilizer are impaired when the

product itself is not installed, used and serviced in accordance with these Instructions for use.

n The Instructions for use updated to the latest version is always

available at www.wh.com.

n Keep these Instructions for use for future reference.

MANUFACTURER RESPONSIBILITY

n The 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.

n Servicing by unauthorized persons invalidates all claims under

warranty and any other claims.

Getting started

CONTENTS

This section deals with the following subjects:

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:

n LARA 17: 42.5 kg (93.7 lbs) n LARA22: 44 kg (97 lbs)

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

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:

n Water container to capture waste water during manual tank

draining (volume larger than (5 l (1.3 gal))

n LAN cable for connecting the sterilizer to a network (optional)

See "Accessories, spare parts, consumables" on page123 for a full list of optional accessories.

Getting started

Handling

HOW TO RELOCATE THE STERILIZER

Before transport:

n Completely drain both water tanks (see "Draining the used and

clean water tank" on page92).

n Allow the sterilization chamber to cool down. n Use original packaging when shipping or transporting the

sterilizer. Replacement packaging materials are available from Service W&H.

Getting started

Product description

FRONT VIEW

Part Description

A Chamber door

B Tank filling cover-cap

C Water tank cover

D Touchscreen

E Service door

F Sterilization chamber

Dust filter

H Reset button of the thermostat switch

I Door seal

L Door pin

UPPER INTERNAL STRUCTURE

Part Description

A Tank

Water level sensor

C Water tank cover

D Internal tank cover

E Tank internal filters with metal cartridges

Getting started

COMPONENTS BEHIND THE SERVICE DOOR

Part Description

A Bacteriological filter

B Mains switch

C Identification label

D Used water drainport (grey)

E Clean water drain port (blue)

F Drain tube release button

G USBport

REAR VIEW

Part Description

USB port (optional)

Air gap cover

Test connection

Pressure safety valve cover

E Used water drain

Water supply inlet

G Condenser grid

H Mains cable guide

I Mains cable plug socket

Getting started

CHAMBER ACCESSORIES

Part Description

Tray

Chamber rack.

n In the normal position, it can host 5 trays horizontallyor 3

cassettes/containers vertically.

n In a 90° degrees rotated position, it can host 3 trays or 3

cassettes/containers horizontally.

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.

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:

1 Insert the Wi-Fi key in the USB port. 2 Read the Instructions for use provided with the Wi-Fi key.

INSTALLINGTHE 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.

1 Place the sterilizer on a resistant, flat and level surface. 2 Open the chamber door, remove all items except the chamber

rack from the sterilizer and close.

3 Remove all the plastic covers from the items. 4 Optional. Connect the used and clean water tubes on the rear. 5 Plug the power cord into the socket in the back of the

sterilizer.

6 Place the power cord in the power cord guides. 7 Connect the power cord to a wall outlet. For power supply

requirements, see "Technical data" on page118.

Getting started

Operating with the sterilizer

POWER ON/OFF THE STERILIZER

1 Press the power switch behind the

service door: the visual indicator on the power switch will turn green.

2 After a quick autotest the

sterilizer automatically turns in standby mode. See "Standby mode" on page33.

3 Tap . The homepage appears

with the enabled sterilization cycles.

Getting started

HOMEPAGE DESCRIPTION

Part Description

A Title/purpose of the screen,

or the cycle number and the current date and time

B Available cycles

Note: The S Fast 134 cycle is optional, activatedwith Fast Cycle activationcode, see "S Fast 134 cycle activation" on page58.

C Available tests

D Additional buttons used to

navigate the menu.

Getting started

User interface menu

STRUCTURE AND NAVIGATION

=optional with Activation code

= optional

Getting started

MAIN MENU FUNCTIONS

Icon

Label

Menu Opens the menu.

Settings Sets the device.

Traceability

Opens the pages to monitor the performed cycledata and manage users and printing.

Accessories Opens the pages to select and calibrate the printers,

format the USB pen drive and activate special functions.

Maintenance Carries out the maintenanceprocedure.

System Info

n In general, shows the system information. n During a cycle,shows the cycle parameters in real

time.

SETTINGS MENU FUNCTIONS

Icon

Device

Label

Opens the pages to set the device.

Function

Icon

Label

Function

Language Sets the language.

Date & Time Sets time and date values and format.

Sterilizer

Sets the sterilizer name.

Name

Energy

Sets the standby mode.

management

Display Sets the display brightness.

Cycle Opens the pages to manage cycles.

Measurement

Sets the unit of measure.

Units

Connectivity Opens the pages to manage the network connection.

WI-FI Activates a communication protocol between the

sterilizer and an external gateway to extend connectivity features.

Network Status

Onlywitha network connectionset. Provides information about the network status.

Getting started

Icon

Label

Remote data storage

Onlywitha network connectionset. Opens the page to manage the remote storage.

Settings Onlywitha network connectionset. Sets the parameters

of the network location.

Save all Only with a network connection set. Copies all the files in

the specified location in the network.

Test Only with a network connection set. Checks if the files can

be copied to the specified location.

TRACEABILITY MENU FUNCTIONS

Icon

Label

CycleHistory Shows all the sterilizationcycles and tests and prints

reports and labels.

Save Saves allthe sterilization cycle reports in the USBpen

drive.

User Management

Add User

Optional,activated with an activation code. Permits manage the users.

Administrator only.Adds a user.

Function

Icon

Label

Delete User Administrator only. Deletes a user.

Reset user PIN

Administrator only.Resets a user PIN code.

code

Change your

Changes the PIN code.

PIN code

Options

Optional,activated with an activation code. Administrator only. Permits the following:

n identify and save the operator who starts the

cycle and releases the load.

n Protect with a password the cycle starts, the load

release and the label printing.

Label Printer

Optional,activated with an activation code.

n Sets the maximum storage time of the wrapped

sterilized items.

n Sets the automatic or manual printing of the

labels.

ACCESSORIES MENU FUNCTIONS

Icon

Label

USB Pen Drive

Opens the formatting page of the USB pen drive.

Function

Getting started

Icon

Label

Format

Label Printer

Local

Formats the USB pen drive.

Optional,activated with an activation code. Selects the label printer and sets the printout layout.

Selects a printer connected to the sterilizer.

Printer

Calibration

Test

Printer

Special Codes

Adjusts the label printer to the edge of the label.

Prints a test label.

Selects the printer model connected to the sterilizer.

Saves the codes issued by the manufacturer to activate special functions. See "Activation codes" on page127.

MAINTENANCE MENU FUNCTIONS

Icon

Label

Bact. Filter Shows the status of the bacteriological filter for

replacement and resets its counter to zero.

Function

Icon

Label

Function

Dust Filter Shows the status of the dust filter for replacement and

resets its counter to zero.

Door Gasket

Software

Shows the status of the door gasket for replacement and resets its counter to zero.

Updates the software.

Update

4000 cycle service

Shows the number of cycles performed and left before the necessary maintenance.

Getting started

COMMON COMMANDS AND ICONS

Icon Function

Enters/exits the standby mode.

Moves to the previous/nextscreen.

Opens the homepage.

Accesses to the sub-menus.

Provides access to the setting screen of a specific area.

Shows the list of all operating parameters of the sterilizer.

Icon Function

Opens a screen withother settings/options.

Refreshes the page.

Indicates the value that may be changed and appears by clicking on it.

n Confirm the active option. n Saves a setting or a

parameter.

n Answers YES to a question.

n Aborts the action/function. n Moves to the previous screen

without confirming/making any changes nor saving any parameters.

n Answers NO to a question.

Indicates that the AUTO DRYmode is operating.

Optional,activated with an activation code.Indicates that the ECO DRY plus mode is operating.

Increases/decreases the value.

Icon Function

Indicates that an error occurs.

Indicates that the option checked is working properly.

n Plays a video. n Starts a procedure.

Pauses a video.

Indicates that the chamber door is locked.

Indicates that the chamber door is locking/unlocking.

Indicates that the chamber door is unlocked and can be open.

Indicates that the option is ON and allows to set it OFF by touching it.

Indicates that the option is OFF and allows to set it ON by touching it.

Getting started

Icon Function

Indicates that the option is active/not active.

Indicates that the option is enabled/disabled.

Indicates that the user is using the administrator credentials.

Confirms the active option and saves a setting or a parameter.

Copy the system info to the USBpen drive.

Shows an animation about the replacement procedure.

Shows a sterilization summary.

Getting started

Sterilizer setup

SET THE LANGUAGE

1 On the homepage tap > >

2 Tap the language you prefer.

3 Tap to confirm: a confirmation

message requiring the restarting of the sterilizer appears.

4 Turn the sterilizer OFF and then ON.

SET THE DATE AND TIME

To change the current date and time:

1 On the homepage tap > >

2 Tap the value you want to change

(time, date, format): the highlighted value can be changed.

3 Tap or to change the value.

4 Tap to confirm and go back to

the previous page.

Getting started

SET THE STERILIZER NAME

To change the sterilizer name that appears in the cycle reports:

1 On the homepage tap > >

2 Tap the text box:a keyboard

appears.

3 Enter the new sterilizer name.

4 Tap to confirm.

5 Tap to go back to the previous

page.

SET THE DISPLAY BRIGHTNESS

To change the display brightness:

1 On the homepage tap > >

2 Tap or to change the value.

3 Tap to confirm and go back to

the previous page.

+ 108 hidden pages

W&H Lara RIL-117, Lara RIL-122 Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Conformity

Symbols and messages

Introduction

About this manual

Use restrictions

Safety information

Safety warnings

Responsibility

Getting started

Unpacking

Handling

Product description

Installing the sterilizer

Operating with the sterilizer

User interface menu

Sterilizer setup