va131 instructions for use eng rev. 05 · lisa |instructionsforuse| va131engrev.05| 31/07/2018|...

VA131-17 VA131-22

Instructions for useVA131 - ENG - Rev. 05

Table of content

LISA | Instructions for use | VA131 ENG Rev. 05 | 31/07/2018 | © 2018 W&H Sterilization Srl iii

Conformity 5Symbols and messages 6

Introduction 7About this manual 7Use restrictions 8

Safety information 9Safety warnings 9Responsibility 10

Getting started 11Unpacking 11Handling 13Product description 14Installing the sterilizer 18Operating with the sterilizer 20User interface menu 22Sterilizer setup 28User authentication 30USB pen drive 31Standby mode 32

Administrator 34User management 34Traceability options 37Cycle and test exclusion and inclusion 37

Managing printers 39Printer selection 39Label printer selection 39Label printer usage 41Label content description 43

Sterilizer tests 44Sterilizer performance tests 44Bowie and Dick test 44Helix test 48Vacuum test 51

Sterilization cycles 53Load maintenance and preparation 53Prepare the sterilizer 55Sterilization cycle description 56Sterilization cycle management 57Unloading 65Sterilization cycle report 65

Maintenance 73Warnings for maintenance operations 73Ordinary maintenance 74Monthly or 50-cycle maintenance 76400-cycle maintenance 81800-cycle or biannual maintenance 83

iv LISA | Instructions for use | VA131 ENG Rev. 05 | 31/07/2018 | © 2018 W&H Sterilization Srl

800-cycle maintenance 884000 cycle or five-year maintenance 90Extraordinary maintenance 91Battery-operated door opening tool 95Disposal 97

Diagnostic 98Errors 98Troubleshooting 103

Technical data 108Sterilization cycles 108Sterilization cycle phases 112Technical data 115Test validation points 116Diagrams 117Water quality 118Accessories, spare parts, consumables 119Authorized W&H service partners 122

Documentation forms 125W&H installation check-list 125Helix test documentation form 128

LISA | Instructions for use | VA131 ENG Rev. 05 | 31/07/2018 | © 2018 W&H Sterilization Srl 5

Conformity

STERILIZER featuring sterilization cycles conform with the followingstandards:

StandardsandDirectives

Description

93/42/EEC

Medical Device Directive (MDD).

Medical Device Directive 93/42/EEC for devices class IIb, inaccordance 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) forevery sterilization chamber designed and manufactured inconformity to the ANNEX 1 and to the procedure described in themodule D1 Annex III.

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

EN 13060 Small steam sterilizer.

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 autoclavesusing steam for the treatment of medical materials and forlaboratory processes.

IEC 61326-1 Electrical equipment for measurement, control and laboratory use:EMC requirements.

IEC 61770 Back syphonage.

Note: See the Declaration of Conformity and the Warranty Card in theenclosed documents.

6 LISA | Instructions for use | VA131 ENG Rev. 05 | 31/07/2018 | © 2018 W&H Sterilization Srl

Symbols and messages

SAFETY SYMBOLS USED IN THIS MANUAL

WARNING: Indicates a hazardous situation that, if not avoided, couldresult in death or serious injury.

In sterilization context indicates hazardous situations that, if notavoided, could result in non-sterile instruments which could lead topersonal or fatal injury.

CAUTION: Indicates a hazardous situation that, if not avoided, couldresult in minor or moderate injury.

SYMBOLS DISPLAYED ON THE PRODUCT

Hot surfaces! Risk ofburn.

Hot steam! Risk of burn. Consult the instructionsfor use for importantcautionary information.

Consult the instructionsfor use.

Do not dispose of withnormal waste

PROPERTY DAMAGE MESSAGESNotice: Indicates information considered important, but not hazard-related. Tipically to avoid damage to the product.

Introduction


CONTENTSThis section deals with the following subjects:

About this manual 7Use restrictions 8

About this manual

INTRODUCTIONThis manual contains the Instructions for Use of the W&H sterilizersVA131-17 and VA131-22, hereinafter referred to as LISA 17 and LISA22.

FOR YOUR SAFETY AND THE SAFETY OF YOUR PATIENTSThe purpose of this manual is to provide information about LISAsterilizers to ensure:n proper installation and set-up;n optimal use;n safe and reliable operation;n compliance with regular maintenance and servicing

requirementsPlease carefully read the safety information (see "Safety warnings"on page 9).

OBLIGATIONS WITH REGARD TO THIS MANUALThis manual is an integral part of the product and accompanies it forits entire working life. It must be consulted in all situations relatedto the life cycle of the product, from its delivery through todecommissioning. For this reason, it should always be accessibleto operators both online and offline.

Contact customer service in the event the manual is unavailable. Ifthe device is transferred, always attach the manual for the newowner.

MANUAL CONTENTThis manual contains the instructions for use and for maintenanceof the following sterilizer versions:n VA131-17 200-240 V acn VA131-22 200-240 V ac

DISCLAIMERAll pictures, graphics and illustrations provided in this manual arefor the comprehension of the text. They are not meant to be anaccurate representation of product details.

Thus, they should be taken as indicative only, and may differ fromthe actual product.

For any suggestion or remark please send an email [email protected].


Introduction

COPYRIGHT NOTICECopyright © 2018, W&H Sterilization Srl

All rights reserved in all countries.

All drawings, images and texts contained in this manual are theproperty of the manufacturer. Even partial duplication of drawings,images or text is prohibited.

The information contained in this document is subject to changewithout prior notice.

Use restrictions

INTENDED USELISA sterilizers are fully automated bench top steam sterilizers thatgenerate steam using electrical heaters.

LISA sterilizers are used for medical purposes (e.g. in generalmedical practices, dental offices, facilities for personal hygiene andbeauty care and veterinary practices). They are also used formaterials and equipment that is likely to be exposed to blood orbody fluids, e.g. instruments used by beauty therapists, tattooists,body piercers and hairdressers.

The types of loads that can be sterilized with LISA sterilizers aredescribed in Table 1 of the reference technical norm EN 13060.These loads include solid, porous, hollow loads type A and hollowloads type B, unwrapped, single wrapped and double wrapped.

LISA sterilizers cannot be used to sterilize liquids or pharmaceuticalproducts.

PROVIDED FEATURESSee "Sterilization cycles" on page 108 for the full list of key programfeatures, including sterilization time, temperature andrecommended load type.

USER QUALIFICATIONThe users who may operate the sterilizer are the following.

Addressees Competences

Head of theclinic/practice

Legally responsible for:n the efficiency of the hygiene protocol in placen the sterilization processn the operators' training and the recording of the training

resultn the correct operation and maintenance of the equipment

Trainedoperators

n Regularly attend the training for operating and using thesterilizer safely.

n Use the sterilizer according to the Head of theclinic/practise instructions.

Safety information



Safety warnings 9Responsibility 10

Safety warnings

THERMAL HAZARDS

n The chamber automatically begins to heat tohigh temperature as soon as the sterilizer isswitched on – risk of burn!

n The trays and the sterilization load are hot at theend of each cycle. Use tray or cassette holdersto empty the sterilization chamber.

n Always wear appropriate PPE during use of thesterilizer (e.g. gloves for cleaning, maintenance,etc...).

ELECTRICAL RISKS

n Do not pour water or any other liquids over thesterilizer (risk of electrical short circuits).

n Switch off the sterilizer and unplug the mainscable before inspecting, carrying outmaintenance or servicing the sterilizer.

n Ensure that the power receptacle the sterilizer isconnected to is properly grounded.

n All electric devices connected to the sterilizershall be of Insulation Class II (double insulated)or higher.

n Use only the power cord set provided by themanufacturer.

IMPROPER USE OF THE STERILIZER

n The sterilizer must not be used in presence ofexplosive or flammable gases, vapors, liquids orsolids.

n The sterilizer has not been designed for thesterilization of foodstuff or waste.

n Do not exceed the maximum load weight limitsas specified in this manual (see "Sterilizationcycle management" on page 57).

n Do not drink any water that has been inside thesterilizer.


Safety information

TAMPERING

n Do not remove the name plate or labels from thesterilizer.

n Repairs, maintenance or service must be carriedout by service technicians authorized by themanufacturer and using genuine spare partsonly.

REQUIREMENTS

n If the sterilizer is connected to a water supplysystem, this must be fitted with a backflowpreventing device complying to IEC 61770.

Responsibility

USER RESPONSIBILITYn The user is responsible for the proper installation, the correct

use and maintenance of the sterilizer in accordance with theseInstructions for Use.

n The safety devices of the sterilizer are impaired when theproduct itself is not installed, used and serviced in accordancewith these Instructions for Use.

n The Instructions for use updated to the latest version is alwaysavailable at www.wh.com.

n Keep manuals for future reference.

MANUFACTURER RESPONSIBILITYn The manufacturer can only accept responsibility for the safety,

reliability and performance of the product when the productitself is installed, used and serviced in accordance with theinstructions for use.

n Servicing by unauthorized persons invalidates all claims underwarranty and any other claims.

Getting started



Unpacking 11Handling 13Product description 14Installing the sterilizer 18Operating with the sterilizer 20User interface menu 22Sterilizer setup 28User authentication 30USB pen drive 31Standby mode 32

Unpacking

UNPACK THE STERILIZER

CAUTION! Heavy product. Two authorized people/techniciansare required to raise the sterilizer.

Weight:n LISA 17: 50.2 kg (110.7 lbs)n LISA 22: 51.7 kg (114 lbs)

WARNINGSNotice: Check the external condition of the box and the sterilizer. Incase of any damage, immediately contact the dealer or shippingagent that has carried out the transport. Keep the packaging forshipping or transporting the sterilizer in future.

Note: The packaging of the product is environmentally friendly and canbe disposed of by industrial recycling companies.


Getting started

CONTENTS OF THE PACKAGING

Sterilizer Trays (five)

Reversible rack Tray holder

Mains cable Drain tube

Tube for drain connection USB pen drive


Getting started

This manual, declaration ofconformity, documentationCD, warranty card, work testreport, maintenance sheet

REQUIRED MATERIALThe following materials are not provided:n 1 LAN cable (optional)n 1 water container (4 l (1.06 gal))

Handling

HOW TO RELOCATE THE STERILIZERBefore transport:n Completely drain both water tanks (see "Draining the used and

clean water tank" on page 91).n Allow the sterilization chamber to cool down.

n Use original packaging. Replacement packaging is availablefrom Service W&H.

Getting started


Product description

FRONT STRUCTURE

Part Description

A Chamber door

B Tank filling cover-cap

C Water tank cover

D Touch screen

E Service door

F Sterilization chamber

G Dust filter

H Reset button of the thermostat switch

I Auxiliary cable loom

L Door seal

M Door pin

Getting started


COMPONENTS UNDER THE SERVICE DOOR

Part Description

A Bacteriological filter

B Mains switch

C Identification label

D Clean water drain port (blue)

E Used water drain port (grey)

F Drain tube release button

G USBport

Getting started


REAR STRUCTURE

Part Description

A Main cable plug socket

B Serial communication, USB and Ethernet ports

C Pressure safety valve cover

D Used water drain

E Water supply inlet

F Condenser grid

G Mains cable guide

Getting started


CHAMBER FURNITURE

Part Description

A Tray

B Chamber rack.n In the normal position, it can host 5 trays horizontally or 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 REQUIREMENTSNotice:Do not place the sterilizer so that it is difficult to operate thecontrols behind the service door. Do not place the sterilizer so thatit is difficult to disconnect the power supply plug.Leave the condenser grid (rear side of the sterilizer) free fromanything that might obstruct the air passage.Surface materials should be water resistant. If sterilization cycleswill 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 fromsources of heat and from flammable materials.Place the sterilizer on a flat and level surface.

Clearance requirements to ensure proper air circulation:

ELECTRICAL CONNECTIONSAll the cables and tubes connected on the rear side of the sterilizermust be placed far from the condenser grid (e.g. using the availableguides).

Notice:Use only the cord set provided by the manufacturer.Ensure that external and internal surfaces are free from moisture orcondensation before connecting to power.The installation of the sterilizer shall be performed by twoauthorized technicians using PPE (Personal Protective Equipment)according to applicable standards.


Getting started

The electrical power supply to the sterilizer must fulfill all applicablestandards in the country of use, and must comply with the datalabel on the back of the sterilizer.

WATER CONNECTIONSThe water supply system must deliver demineralized or distilledwater meeting the standard requirements. Do not add anychemical/additive to the water.

The manufacturer’s warranty is void if the sterilizer was used withwater containing either chemical additives, or contaminant levelsexceeding those listed in these instructions. See "Feed waterspecifications (EN 13060)" on page 118.

Notice: The maintenance of the external water filling system mustbe done in exact accordance with the instructions for use given withthe relevant system.

LAN CONNECTION

1 Insert the plug of a standardEthernet cable in theEthernet port.

2 Insert the other end of thecable in the Ethernet wallsocket: when the sterilizerwill be switched on it willconnect automatically to theLAN.

WI-FI CONNECTIONFor 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.


Getting started

INSTALLING THE STERILIZER

WARNING! In case of sterilizer malfunctions immediatelyunplug the sterilizer and call for service. Do not attempt torepair the sterilizer yourself.

Notice:Please refer to technical requirements before to plug the sterilizer!See "Diagrams" on page 117.No other devices should be connected to the sterilizer power panelcircuit.

1 Put the sterilizer on a resistant, flat and level surface

2 Open the chamber door, remove all items except the chamberrack from the sterilizer and close.

3 Remove all the plastic covers from the items.

4 Connect the used and clean water tubes on the rear.

5 Optional. Connect Ethernet cable. See "LAN connection" on theprevious page.

6 Plug the power cable into the socket in the back of thesterilizer.

7 Place the power cable in the power cable guides.

8 Connect the power cable to a wall outlet. For power supplyrequirements, see "Technical data" on page 115

Operating with the sterilizer

POWER ON/OFF THE STERILIZER

1 Press the power switch behind theservice door: the visual indicator onthe power switch will turn green.


Getting started

2 After an autotest the sterilizer turnin standby mode. See "Standbymode" on page 32.

3 Tap . The homepage appearswith the enabled sterilizationcycles.

HOMEPAGE DESCRIPTION

Part Description

A Title/purpose of the screen,or the cycle number and thecurrent date and time

B Available cycles

C Available tests

D Additional buttons used tonavigate the menu.

Getting started


User interface menu

STRUCTURE AND NAVIGATION


Getting started

MAIN MENU FUNCTION

Icon Label Function

Menu Opens the menu.

Settings Sets the device.

Traceability Opens the pages to monitor the performed cycle data andmanage users and printing.

Accessories Opens the pages to select and calibrate the printers,format the USBpen drive and activate special functions.

Maintenance Carries out the maintenance procedure.

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

time.

SETTINGS MENU FUNCTIONS

Icon Label Function

Device Opens the pages to set the device.

Icon Label Function

Date & Time Sets time and date values and format.

Language Sets the language.

Energymanagement

Sets the standbymode.

SterilizerName

Sets the sterilizer name.

Audio Manages the sterilizer sounds.

Display Sets the display brightness.

Cycle Opens the pages to manage cycles.

CycleExclusion

Sets the cycles menu.

MeasurementUnits

Sets the unit of measure.

Daily CycleProgram

Programs a sequence of cycles to be run on daily basis.


Getting started

Icon Label Function

Connectivity Opens the pages to manage the network connection.

Eliso Status Only with a Wi-Fi or Ethernet connection set. Showsinformation about the connection status.

WI-FI Selects a Wi-Fi network when a Wi-Fi key is connected.

Ethernet Manages the Ethernet network.

NetworkStatus

Only with a network connection set. Provides informationabout the network status.

Remote datastorage

Opens the remote folder.

Settings Sets the parameters of the network location.

Save all Copies all the files in the specified location in the network.

Test Checks if the files can be copied to the specified location.

TRACEABILITY MENU FUNCTIONS

Icon Label Function

UserManagement

Permits manage the users.

Add User Administrator only. Adds a user.

Delete User Administrator only. Deletes a user.

Reset user PINcode

Administrator only. Resets a user PIN code.

Change yourPIN code

Changes the PIN code.

Options 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 n Sets the maximum storage time of the wrappedsterilized items.

n Sets the automatic or manual printing of thelabels.


Getting started

ACCESSORIES MENU FUNCTIONS

Icon Label Function

USB PenDrive

Opens the formatting page of the USB pen drive.

Format Formats the USBpen drive.

LabelPrinter

Selects the label printer and sets the printout layout.

LocalPrinter

Selects a printer connected to the sterilizer.

SharedPrinter

Selects a printer connected to another sterilizer(connected via local network)

Calibration Adjusts the label printer to the edge of the label.

Test Prints a test label.

Printer Selects the printer model connected to the sterilizer.

SpecialCodes

Only for technical support. Saves the codes issued by themanufacturer to activate special functions.

MAINTENANCE MENU FUNCTIONS

Icon Label Function

Hepa Filter Shows the status of the bacteriological filter forreplacement and resets its counter to zero.

Dust Filter Shows the status of the dust filter for replacementand resets its counter to zero.

Door Gasket Shows the status of the door gasket forreplacement and resets its counter to zero.

[*MN*] hascompleted 4000cycles.

Shows the number of cycles performed and leftbefore the necessary maintenance.


Getting started

COMMON COMMANDS AND ICONS

Icon Function

Enters/exits the standbymode.

Moves to the previous/next screen.

Opens the homepage.

Accesses to the sub-menus.

Provides access to the settingscreen of a specific area.

Shows the list of all operatingparameters of the sterilizer.

Icon Function

Opens a screen with othersettings/options.

Refreshes the page.

Indicates the value that may bechanged and appears by clicking onit.

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/makingany changes nor saving anyparameters.

n Answers NO to a question.

Indicates that the ECODRYmode withextended drying is operatingautomatically.

Indicates that the ECODRY plusmode is operating automatically.

Increases/decreases the value.

Icon Function

Indicates that an error occurs.

Indicates that the option checked isworking properly.

n Plays a video.n Starts a procedure.

Pauses a video.

Indicates that the chamber door islocked.

Indicates that the chamber door islocking/unlocking.

Indicates that the chamber door isunlocked and can be open.

Programs a succession of cycles fordaily repetition.

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

Icon Function

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

Indicates that the option isactive/not active.

Indicates that the option isenabled/disabled.

Indicates that the user is using theadministrator credentials.

Gives information about the functiondisplayed.

Confirms the active option andsaves a setting or a parameter.

Copy the system info to the USBpendrive.

Shows an animation about thereplacement procedure.

Icon Function

Shows a sterilization summary.


Getting started


Getting started

Sterilizer setup

SET THE LANGUAGE

1 In the homepage tap > >>

2 Tap the language you prefer.

3 Tap to confirm: a confirmationmessage requiring the restarting ofthe sterilizer appears.

4 Turn the sterilizer OFF and then ON.

SET THE DATE AND TIMETo change the current date and time:


2 Tap the value you want to change(time, date, format): the highlightedvalue can be changed.

3 Tap or to change the value.

4 Tap to confirm and go back tothe previous page.


Getting started

SET THE STERILIZER NAMETo change the sterilizer name that appears in the reports:


2 Tap the text box: a keyboardappears.

3 Enter the new sterilizer name.

4 Tap to confirm.

5 Tap to go back to the previouspage.

SET THE DISPLAY BACKLIGHT AND CONTRASTTo change the display settings:


2 Tap or to change the value.



Getting started

SET THE NETWORK ADDRESSRefer to your network administrator or IT manager for moreinformation about your network.

If your network supports dynamic IP, skip this procedure. Otherwisefollow this procedure and enter the data suggested by your networkadministrator or IT manager.


2 In IP Configuration tap Static: thetext boxes is enabled.

3 Enter the data: the frames highlight.If a frame turns dark grey, checkand correct the entered data.

4 In DNS Configuration tap Static: thetext boxes is enabled.

5 Enter the data: the frames highlight.If a frame turns dark grey, checkand correct the entered data.

User authentication

PIN MANAGEMENTPIN “0000” is assigned as default to each new user. It has to bechanged at the first login. When the PIN is reset the default value“0000” is reassigned.

CHANGE YOUR PINChange your PIN the first time you use the sterilizer and if your PINhas been reset. This will prevent other users to use your account.

1 In the homepage tap > >

2 Tap your user name.

3 Enter your current PIN and tapto confirm.

4 Tap .


Getting started

5 Enter your new PIN and tap toconfirm: a confirmation messagewith your new PIN appears.

6 Tap and then to go back tothe previous page.

WHAT TO DO IF YOU FORGET YOUR PIN

If you are... Then contact...

a common user the administrator

the administrator the technical service

USB pen drive

DESCRIPTIONA USB pen drive is available to be installed in order to automaticallyrecord all the sterilization cycle reports. The USB pen drive can beinserted equally into the front or rear port.

Notice: Periodically remove the USB pen drive to save the cycledata on a computer or on another safe support.

FORMAT THE USB PEN DRIVE


2 Insert the USB pen drive in one ofthe two USB ports.

3 Tap .

4 Tap to confirm: all data will beerased.

Notice: Formatting erases all data fromthe pen drive. Be sure you have alreadysaved your data on a safe supportbefore formatting.


Getting started

Standbymode

DESCRIPTIONIn the standby mode the display remains dark and the sterilizerchamber is no longer heated to save energy. If the sterilizer is notused for a certain period of time, it switches automatically tostandby mode.

ENTER THE STANDBY MODE MANUALLY

1 Homepage

2 Tap .

EXIT THE STANDBY MODE

1 Tap .

2 or open or close the chamber door.


Getting started

CHANGING STANDBY MODE DELAY


2 Tap On/Off to enable/disable thestandby mode.

3 Tap or to change the delay.


Administrator



User management 34Traceability options 37Cycle and test exclusion and inclusion 37

User management

WHO CAN MANAGE USERS AND RESET THEIR PINOnly a user with administrative rights can create and delete usersand reset the PIN code of a user to "0000".

ADD A USER



3 Enter the PIN and tap to confirm.

4 Tap .


Administrator

5 Tap the text box: a keyboardappears.

6 Enter the new user name and tapto confirm.

7 Tap to give the administratorauthority to the new user.

8 Tap to confirm: the PIN of thenew user is set to "0000" and aconfirmation message appears.

9 Tap and then to go back tothe previous page.

10 Tap to log out.

DELETE A USER





Administrator

4 Tap .

5 Tap the user name you want todelete.

6 Tap to confirm.

RESET A USER PIN




4 Tap and the user name for whichyou want to reset the PIN.

5 Tap to confirm: the PIN is set to"0000" and a confirmationmessage appears.

6 Tap to log out.

Note: Remember the user to change theirPIN before reusing the sterilizer.


Administrator

Traceability options

WHO CAN SET THE TRACEABILITY OPTIONSOnly a user with administrative rights can set the traceabilityoptions.

SET THE TRACEABILITY OPTIONS



3 Enter your PIN and tap toconfirm.

4 Tap the information to be requestedto the users at the beginning and atthe end of the cycle.

5 If you want the user to check theload and release it as valid at theend of the cycle, tap .


Cycle and test exclusion and inclusion

WHO CAN HIDE/SHOW A CYCLEOnly a user with administrative rights can hide a cycle or make itavailable to users in the homepage.


Administrator

HIDE/SHOW A CYCLE OR TEST



4 Enter your PIN and tap toconfirm.

4 Tap to hide a cycle or testfrom the homepage.

5 Tap to show a cycle or testin the homepage.


Managing printers



Printer selection 39Label printer selection 39Label printer usage 41Label content description 43

Printer selection

SELECT THE PRINTER


2 Tap the model of the printer to use.


Label printer selection

LABEL PRINTER SETUP (ONLY WITH A LAN CONNECTION SET)Labels can be printed by a local label printer or a shared labelprinter. The local label printer is connected to the sterilizer, whilethe shared label printer is connected to another sterilizer in thenetwork.

SELECT AND CALIBRATE A LOCAL LABEL PRINTER


2 Tap : the local printer is locatedautomatically.


Managing printers

3 Tap to center the printoutproperly in the label area.

4 Tap to print a test label.

5 If the printout is not duly centered,tap or to center ithorizontally (x) and vertically (y).

6 If necessary, tap to printanother test label and repeat step4.

7 Tap to confirm the settings andgo back to the previous page.

SELECT A SHARED LABEL PRINTER

1 Ensure the sterilizer to which theprinter is physically connected isON and no cycle is running.

2 From that sterilizer, tap > >.

3 Depending on the LAN connection,take note of the Ethernet or Wi-Fi IPaddress. Depending on the LANconnection, take note of the IPaddress.

4 Do not switch OFF the sterilizeruntil the whole procedure iscomplete.

5 From the sterilizer from which theprinter is not physically connected,tap homepage > > > .

6 Tap .


Managing printers

7 Tap the text box and enter the IPaddress previously noted.

8 Tap to confirm.

9 From the sterilizer to which theprinter is connected, confirm theprinter sharing.

10 Tap to print a test label again.

Label printer usageCAUTION! For your safety and the safety of your patients usea storage time compliant with the recommendations of themanufacturers of the containters/packaging used, and withapplicable norms and rules.

AUTOMATIC PRINTING OPTIONThe automatic printing option permits to automatically print apreset number of labels after a successful sterilization cycle. Thelabels are printed only after the user has identified him/herself (withpassword if required) and the load has been checked and released,if these options have been enabled by the administrator.

For the automatic label printing, a maximum storage time in weekscan be set. This value is used to calculate the expiry date to beprinted on the labels (see "Label content description" on page 43).


Managing printers

SET THE AUTOMATIC LABEL PRINTING


2 Activate Automatic printing.

3 Tap or to set the maximumstorage time and the number oflabels to be printed automatically.


SET THE MANUAL LABEL PRINTINGThe manual printing option permits the user at the beginning of asterilization cycle to set manually the number of labels to print.


2 Activate Manual printing.


DISABLE THE LABEL PRINTINGIf the label printing is disabled, no label can be printed at the end ofa sterilization cycle.


2 Activate Disabled.


Managing printers


Label content description

STRUCTURE

Part Description

A n Sterilizer modeln Serial numbern Software release

B Traceability code (alphanumerical and bar code)

Released Depending on the traceability settings, this field may contain one of thefollowing elements:n the user who released the cyclen the user who started the cyclen the sterilizer ID

Cycle Cycle name

Number Cycle number

Date Date and time of cycle start

Expirydate

n Expiry date of the bag/package.n The cycle outcome if a storage time is not set.


Sterilizer tests


Sterilizer performance tests 44Bowie and Dick test 44Helix test 48Vacuum test 51

Sterilizer performance tests

TESTS THAT CAN BE PERFORMED ON THE STERILIZER

Test Purpose Reference

Bowie and Dick test Validate the sterilizer performance for textile load sterilization. See "Bowie and Dick test" below.

Helix test Validate the sterilizer performance for hollow items. See"Helix test" on page 48.

Vacuum test Validate the sterilizer performance in terms of:n efficiency of the vacuum pumpn tightness of the pneumatic circuit

See "Vacuum test" on page 51.

Bowie and Dick testCAUTION! Follow local/national guidelines on the frequency of testing.

Sterilizer tests


PURPOSE OF THE TESTThe test is used to validate the sterilizer performance for textile load sterilization.

DESCRIPTIONIt consists of several sheets of paper wrapped in a small packet with a chemical heat-sensitive indicator sheet in the middle. The colourassumed by this indicator sheet at the end of the sterilization cycle gives the result of the test.

CARRY OUT THE TEST (IN ACCORDANCE WITH EN13060)

1 Empty the sterilizer chamber to ensure no load is present. Do not remove thestandard chamber accessories mounted (e.g. chamber rack and trays).

2 Place the Bowie and Dick test pack in the center of a tray in the lowest rackposition and close the chamber door.

Sterilizer tests


3 In the homepage tap .

4 Tap and enter your credentials if required: the chamber door locks.

5 Wait until the end of the test and tap OPEN: the chamber door unlocks.

6 Enter your credentials if required.

7 Open the chamber door, extract the tray using the tray holder and take the testpack. The test pack can be wet outside.

CAUTION! Risk of burn. The test pack is very hot at the end of the cycle. Wearappropriate PPE (e.g. gloves).

8 Remove the indicator sheet from the center of the test pack and check thechange in colour. See "Interpret the test result" on the next page

Sterilizer tests


INTERPRET THE TEST RESULT

Indicator What happenedTestpassed

What to do next

The entire surface of the indicator sheet has changed colour. Yes -

Certain ares of the indicator sheet have not changed colour since there was an airpocket during the cycle due to sterilizer malfunction.

No Repeat the test. If it failsrepeatedly, call technical service.

Sterilizer tests


Helix testCAUTION! Follow local/national guidelines on the frequency of testing.

PURPOSE OF THE TESTThe test is used to validate the sterilizer performance for hollow items.

DESCRIPTIONIt consists of a 1.5 m long tube open on one side and closed with a capsule containing a chemical indicator strip on the other side. The colourassumed by this indicator strip at the end of the sterilization cycle gives the result of the test.

CARRY OUT THE TEST (IN ACCORDANCE WITH EN13060)

1 Empty the sterilizer chamber to ensure no load is present. Do not remove thestandard chamber accessories mounted (e.g. chamber rack and trays).

2 Unscrew the tube capsule and place inside it an indicator strip according to theinstructions of the test manufacturer.

3 Screw the capsule.

Sterilizer tests


4 Place the tube with the capsule in the center of a tray in the lowest rack positionand close the chamber door.




8 Enter your credentials if required.

Sterilizer tests


9 Open the chamber door, extract the tray using the tray holder and take the tube.

CAUTION! Risk of burn. The test pack is very hot at the end of the cycle. Wearappropriate PPE (e.g. gloves).

10 Unscrew the tube capsule and remove the indicator strip.

11 Check the change in colour. See "Interpret the test result" below

INTERPRET THE TEST RESULT

Indicator What happenedTestpassed

What to do next

The indicator strip has turned dark. The air was completely removed fromthe capsule.

Yes -

Part of the chemical indicator strip has not turned dark. The air removalfrom the capsule was not complete.

No Repeat the test. If it fails repeatedly,call technical service.

WHAT TO DO NEXTCompile the Helix test documentation form to trace the effectiveness of the sterilization cycle during the whole lifespan of your sterilizer. See"Helix test documentation form" on page 128.

Sterilizer tests


Vacuum testCAUTION! Follow local/national guidelines on the frequency of testing.

Notice: If a drainage period of the S Fast 134 cycle is still operating, wait the drainage to be finished and the sterilizer to be both cold and dry.Otherwise, a false negative outcome could occur.

PURPOSE OF THE TESTThe test is used to validate the sterilizer performance in terms of:n efficiency of the vacuum pumpn tightness of the pneumatic circuit

DESCRIPTIONIt consists of a vacuum phase, followed by a stabilization period of 5 minutes and a testing period of 10 minutes. The internal pressure ismonitored during the testing period. The pressure rise must be less than 0.013 bar (0.19 psi).

CARRY OUT THE TEST

1 Empty the sterilizer chamber to ensure no load is present.

2 Close the chamber door and ensure the sterilizer chamber is completely dry andcold to avoid any false negative outcome.

Sterilizer tests





6 Enter your credentials if required: a message informs if the test passed or failed.If the test failed, see "What to do when the test failed" below

WHAT TO DOWHEN THE TEST FAILED

1 Check, clean or replace the door gasket.

2 Clean the chamber face side and the chamber filter.

3 Repeat the Vacuum test. See "Carry out the test" on the previous page.

4 If the test fails repeatedly, call technical service.

Sterilization cycles



Load maintenance and preparation 53Prepare the sterilizer 55Sterilization cycle description 56Sterilization cycle management 57Unloading 65Sterilization cycle report 65

Load maintenance and preparation

WARNINGS

WARNING! Any residual of chemicals (like cleaning anddisinfection products), could affect the purity of the steamand consequently the whole sterilization process.If necessary, the load shall be cleaned and lubricated inaccordance with the instrument manufacturer’sinstructions.

Notice: Any residual of chemicals could seriously damage thesterilizer. The manufacturer’s warranty is void in case of damagecaused by chemicals.

DENTAL HANDPIECES EXTERNAL DISINFECTIONThis procedure reduces the risk of infection during cleaning andmaintenance of the dental handpieces.n Wear protective gloves during disinfection.n Avoid using abrasive disinfectants (pH-value 2.5 – 9; no

chlorine based disinfectants).n Use disinfectant wipes rather than spray disinfection.n Do not immerse handpieces in disinfectants.n Residual disinfectants on handpieces can cause extensive

damage to your instrumentation during sterilization (oxidation,alteration of technical characteristics of seals, rubbers, fiberoptics, etc.)



DENTAL HANDPIECES EXTERNAL CLEANINGThis procedure involves the removal of residues (blood, dentine,etc.) that adhere to critical areas such as spray outlets, light ports,knurling etc.n Wear protective gloves during cleaning.n Refer to the instructions of the instrument manufacturer.n Use a soft, damp brush and take care not to scratch the

surface of the light ports.

DENTAL HANDPIECES LUBRICATIONOnce the dental handpieces has been disinfected, cleaned and dried(free from residues), it must be lubricated prior to sterilization.Follow manufacturer’s instructions for proper lubrication.

PACKAGINGIn order to preserve sterility, rotating instruments should bewrapped/bagged prior to sterilization. Follow the manufacturer’spacking instructions when using sterilization packaging.

CLEANING THE INSTRUMENTSClean all instruments thoroughly prior to sterilization. If possible,clean instruments immediately after use; always follow theinstrument manufacturer ‘s instructions. Remove all traces ofdisinfectants and detergents. Rinse and dry carefully allinstruments.

The instruments and tubes must be carefully rinsed and dried priorto sterilization.

CORRECT LOAD PLACEMENT

WARNING! Do not overload trays and the chamber. Adhere tothe maximum load weight limits (see "Sterilization cycles"on page 108).Never place the load or the trays directly into the chamberwithout the chamber rack as this could affect the steamand temperature distribution. The load must always besupported by the chamber rack.Risk of burn. Before touching, ensure the sterilizationchamber is cold.

Wrap items with porous wrapping materials to facilitate steam

penetration and drying (e.g. sterilization bags for autoclaves).

Always use the chamber rack to allow adequate steam

circulation.

Follow these requirements:

Load type Placement

Hinged instruments (e.g.,forceps, extraction pliers, etc.)

In open position

Tubes Place tubes on a tray allowing the ends to remainopen. Do not bend tubes.

Cassettes Vertical position (if possible) to enhance drying



Load type Placement

Pouched items On trays allowing adequate space in-betweenbags. Ensure that packs do not touch the walls ofthe chamber. Place sterilization pouched itemswith the paper side facing up.

Empty containers or non-perforated trays

Upside down to prevent accumulation of water

Items made from differentmaterials (stainless steel,carbon steel, aluminum, etc.)

On separate trays or wrapped/pouched

Instruments manufacturedfrom carbon steel

Place paper among them and the trays to avoidrusty spots

PARTIAL LOADIf the chamber is just partially loaded, place the load in such a waythat the space in-between the trays is maximized. The weight mustbe spread as evenly as possible among the trays. Below anexample with three trays.

Prepare the sterilizer

WARNINGSNotice: Use only distilled or demineralized water (see "Feed waterspecifications (EN 13060)" on page 118 for technicalrequirements). Do not add any chemical / additive to the water.

FILLING THE CLEAN WATER TANK1 Switch the sterilizer ON and remove the tank filling cover-cap.

2 Fill the clean water tank with distilled or demineralized wateruntil the sterilizer makes a sound. See "Technical data" on



page 115 for the tank capacity.

3 Reposition the tank filling cover-cap.

INSERTING THE CHAMBER RACK INTO THE STERILIZER

CAUTION! Risk of burn. Before touching the chamber rack orcontents, ensure the sterilization chamber is not hot.

1 Open the chamber door and align the chamber rack at thecenter/bottom of the chamber.

2 Push the chamber rack gently into position until it clicksinto place.

3 Insert cassettes horizontally or vertically, or insert trays.See "Load maintenance and preparation" on page 53 forload requirements and "Chamber furniture" on page 17.

4 Close the door.

5 Turn the sterilizer switch ON: after the inizialization thehomepage appears.

GENERAL RECOMMENDATIONSFollow these recommendations to obtain the most from the drying:n Ensure the paper side of the sterilization bags faces up, and

that the space in-between bags is enough.n To enjoy the full benefit of short cycle times, always place the

load on the uppertray of the chamber rack and remove othertrays from the chamber.

Sterilization cycle description

AVAILABLE STERILIZATION CYCLESSee "Sterilization cycles" on page 108 for the full list of key programfeatures, including sterilization time, temperature andrecommended load type.

AVAILABLE ECO DRY MODES

Icon Mode Description

ECODRYplus

The drying time is automatically adjusted to the shortestpossible for the total amount of load: the smaller the load, thefaster the cycle. It ensures perfect drying of standard loads.

ECODRY

The drying time is automatically adjusted to the total amount ofload. It is longer than the ECODRY plus mode.

It is useful with those particular loads that require an extendeddrying time (suggested for container load).

ECODRY+25%

The drying time is automatically adjusted to the total amount ofload with a 25% of additional drying duration.

ECODRY+50%

The drying time is adjusted to the total amount of load with a50% of additional drying duration.



Sterilization cycle management

RUN A STERILIZATION CYCLE IMMEDIATELY

1 In the homepage tap the desiredcycle.

2 Check the cycle requirements.

3 Check the icon in the top left cornerof the page to know the ECO DRYmode assigned to the cycle.

4 Tap :n to change the ECO DRY mode

(see "Change the ECO DRYmode" on page 62).

n to disable the ECO DRY mode(see "Set the drying time" onpage 61).

5 If the door seal is new, hold thedoor gently closed until step 7.

6 Tap and enter your credentials ifrequired: the door locks. If you havenot set a different start time, thesterilization starts immediately.



7 Wait the end of the sterilization. Tapto view the cycle parameters in

real time. See "View the cycleparameters" on page 62.

8 The sterilization is completed. Tapto view the cycle summary or

tap to view the cycleinformation. See "View the cycleparameters" on page 62.

9 Tap OPEN: the door unlocks.

10 If required, enter your credentialsand confirm the release of the loadif needed.

SET THE STERILIZATION CYCLE STARTYou may schedule the start of the sterilization cycles at a certaindate and time (e.g., if you want to load the sterilizer in the eveningand run standard sterilization cycle early the next morning beforeoffice hours). You can set the cycle start date and time and enableor disable it for each cycle.

1 In the homepage tap the cycle and.

2 Tap the leaf icon to set the ECO DRYmode.



3 Tap the ECO DRY mode you desire.


5 To change the start time, tap Startcycle at.

6 Tap the time or the date: a settingspage opens.

7 Tap the number you want to changeand tap or to increase it ordecrease it.


9 Tap to lock the door and startthe countdown for the currentcycle.

Note: You can decide to start thecycle immediately or stop thecountdown at any time.



PROGRAM A SEQUENCE OF CYCLES TO RUN AUTOMATICALLYIt is possible to program the sterilizer in such a way that asequence of cycles runs automatically at a preset date and time(e.g. if you want to run a vacuum test plus a HELIX test in the earlymorning before office hours). Maximum two cycles can beprogrammed.

To program the sterilizer proceed as follows:

1 Load the chamber and close thechamber door.


3 Tap to add a cycle to the listabove.

4 Tap and then the cycle you wantto add.

5 Tap : the cycle is automaticallylisted in the previous page.

6 Tap the date/time to set the start ofthe cycle.



7 Tap the number you want to changeand tap or to increase it ordecrease it.


9 Repeat steps from 3 to 7 to addanother cycle to the sequence.

10 Tap to launch the programmedsequence.

DELETE A CYCLE FROM A PROGRAMMED SEQUENCE


2 Tap the cycle you want to removefrom the sequence.

3 Tap to remove the selectedcycle.


SET THE DRYING TIMEFor each ECO DRY mode, the drying time is automatically adjustedto the total amount of load and cannot be modified. To set a newdrying time for the program, you should disabled the ECO DRY modefirst.


2 Select Fixed to disable the ECO DRYmode.

3 Tap the wording Fixed to modify thefixed mode minutes.



4 Tap or to increase theminutes or decrease them.

Note: for the minimum value of thedrying time for each cycle see"Sterilization cycles" on page 108.

5 Tap to confirm and go back tothe previous page. This becomesthe new fixed value.

CHANGE THE ECO DRY MODE


2 Tap the leaf icon to set the ECO DRYmode.

3 Tap the ECO DRY mode you desire.


5 Tap to go back to the homepage.

VIEW THE CYCLE PARAMETERSYou can check the real time cycle parameters or the cycleparameters at the end of the cycle. Following is an example:

1 While the sterilization cycle isrunning or when cycle ends tap :the cycle information page opens.

2 Tap or to scroll the pages.



STERILIZATION CYCLE PAGEFollowing are the information displayed while a cycle is running:

Part Description

A Sterilization cycle name

B ECODRYmode enabled

C Countdown clock (time untilthe cycle completion)

D : chamber pressure

: cycle counter

: chamber temperature

E Date and time and doorsecurely locked symbol

F Current cycle phase

G Stop button

H Button to open the cycleinformation page

END OF A STERILIZATION CYCLEAt the end of the S Fast 134 cycle, the sterilizer could perform twodrainage periods of about 30 seconds each and the message"Draining" is displayed.

When a cycle is successfully finished, the "Cycle completed"message appears on the screen. To end the cycle:

1 Tap to view the cyclesummary or tap to view thecycle parameters. See "Viewthe cycle parameters" on theprevious page.

2 Tap OPEN to open the door: thedoor unlocks and the homepage appears.

Note: if an error message appearssee "Troubleshooting" on page 103

CAUTION! Hot surfaces.Burnings. Do not touch thechamber, the internal sideof the door and the internalfittings. Use the tray holderor cassette holder orgloves for hightemperatures or adequateprotection to remove theload!

3 Open the chamber door.

4 Remove the load and stock it.



STOP A STERILIZATION CYCLE

WARNING! You can stop the cycle at any time. Instrumentsmust not be considered sterile if this occurs before the DRYphase.

A cycle can be manually aborted at any time. To stop a cycle:

1 Tap STOP: a confirmation requestappears.

2 Tap to abort the stop command.The cycle continues programmed.

3 Tap to abort the cycle: thesterilizer starts a reset phase.

Notice: Do not switch off the sterilizerduring the reset phase: it takes sometime to reset the system and reachsafe conditions in the sterilizerchamber.



4 Check the message. See"Messages of a stoppedsterilization cycle" below.

5 Tap to view the cycle parameters.See "View the cycle parameters" onpage 62.

6 Open the chamber door.

7 Reprocess the load if necessary.

CAUTION! Hot steam. Waitthe steam to dissipatebefore opening the door.

Note: Water could be present in thechamber when opening the door. Toprevent spilling place a towel belowthe chamber door.

MESSAGES OF A STOPPED STERILIZATION CYCLEFollowing are the messages:n Load not sterile: Do not use items on patients!n Drying interrupted: The load might be wet. Wet items are for

immediate use only!

Unloading

WARNINGS

CAUTION! Risk of burn. Before touching, ensure thesterilization chamber is cold. Always use the tray holder.

Sterilization cycle report

WHERE CYCLE DATA ARE STOREDThe sterilizer stores in memory the summarized reports of the last400 cycles and the analytical reports of the last 50 cycles. Allreports can also be saved on the USB pen drive or in a specificremote folder in the network if the sterilizer is connected to a LAN .

STORED REPORT FORMATThe summarized reports are stored in HTML format and theanalytical reports in SCL format. All parameters are recorded everysecond.



WHAT HAPPENS WITH UNSAVED CYCLESIf for any reason (e.g. USB memory full, USB pen drive disconnected,etc.) some cycles cannot be saved, no alert is shown. If still storedin memory, the unsaved cycles will be copied in a working USB pendrive connected to the sterilizer as soon as a new cycle starts.

VIEW CYCLE HISTORYTo view the sterilization cycle history:

1 In the homepage tap > >: all the sterilization cycles arelisted with number, date, time andsterilization program. Thesterilization cycle interruptedbecause of a cycle error or problemappears in red.

2 Scroll the list and tap the desiredsterilization cycle: the reportopens.

PRINT OR SAVE A CYCLE REPORT ON THE USB PEN DRIVE



3 Tap .



4 Tap to print the report, or tapto save the report on the USB pendrive.

PRINT LABELS FOR A SPECIFIC CYCLE



3 Tap .

4 Tap to print traceability labelsfor the selected cycle.



5 Tap or to increase ordecrease the number of label to beprinted.

6 Tap to save the set number forthe next time.

7 Tap to print the labels required.

SAVE ALL THE CYCLE REPORTS ON THE USB PEN DRIVE

The number of reports that can be saved on the USB pen drivedepends upon the USB capacity. To save all the cycle reports:


2 Tap : after the confirmation allsterilization cycle reports arestored in the USB.

SET THE REMOTE FOLDER FOR SAVING THE REPORTSTo activate the remote storage and set the necessary parametersdo the following:


2 Tap to enable the remotedata storage: the first four fields inthe page and the check box turndark grey.

3 In Path enter the name of theshared folder followed by the sub-folder name, if any, where to savereports. Do not enter the full path.

Note: The folder name must includeletters and numbers only. Do notuse other characters like space-bar,slash, accent, etc.

4 Enter the host name or the IPaddress: if the data are complete,the fields highlight.



5 Not mandatory. Enter the domainname.

6 Tap to require theauthentication credentials toaccess the remote storage folderand enter the user name andpassword.

7 Tap to save.


9 To check if the parameters enteredare valid, see "Test the datastorage " below.

TEST THE DATA STORAGENote: The test function is available only if the remote data storage isenabled. See "Set the remote folder for saving the reports" on the previouspage.


2 Tap : a sequence of tests isautomatically performed.

3 In case an error occurs, correct itand tap to repeat the test.




SAVE ALL THE CYCLE REPORTS IN A REMOTE FOLDERNote: The save all function is available only if the remote data storage isenabled. See "Set the remote folder for saving the reports" on page 68.

Only the last 400 cycles in HTML and 50 cycles in SCL in thesterilizer memory can be saved in the remote folder.


2 Tap to start the remote saving.



CYCLE REPORT STRUCTUREFollowing the structure of a cycle report:

Data Description

A Sterilizer model

SN Sterilizer serial number

Software rev. Software revision number

Sterilizer Name Surgery – practice – doctor name

Cycle Name of the executed cycle

Number Cycle counter

Sterilizat. temp. Programmed sterilization temperature

Sterilizat. time Programmed Plateau/Sterilization

Date (above) Cycle start date and time

START Cycle start

PV1, PP1, PV2, PP2,PV3

Pressure and vacuum pulses

PPH Phase of pressure rise to sterilization conditions

PRS Plateau/Sterilization phase startn MIN, MAX temperaturen MIN, MAX pressure

PRE Plateau/Sterilization phase end

DVS Drying phase start

DVE Drying phase end

SEP Chamber venting phase

LEV Pressure leveling phase



Data Description

END Cycle end conditions

H20 Cycle water consumption

F0 F0 value

Cycle time Cycle time

Date(below) Cycle end date and time

"Cycle completed" Cycle outcome

Trk. Tracking code for traceability management

Maintenance



Warnings for maintenance operations 73Ordinary maintenance 74Monthly or 50-cycle maintenance 76400-cycle maintenance 81800-cycle or biannual maintenance 83800-cycle maintenance 884000 cycle or five-year maintenance 90Extraordinary maintenance 91Battery-operated door opening tool 95Disposal 97

Warnings for maintenance operations

WARNINGS

WARNING! Turn the sterilizer OFF and remove the powercord before beginning any maintenance. Follow all health,safety, cross-infection and cross-contamination protocols.Maintenance operation shall be done at illumination level of215 lx (±15 lx) to 1500 lx (±15 lx).Before making any operation, ward off unauthorizedpersonnel from the working area.

CAUTION! Before accessing the chamber and the connectedparts, be sure that the sterilizer is cold.

Notice: Follow the instructions in this chapter when carrying out anymaintenance on the sterilizer.


Maintenance

Ordinary maintenance

MAINTENANCE BY THE USER

Frequency 1 Cycles 1 Operation

Monthly 50 Cleaning the door seal and the chamber faceside. See "Cleaning the door seal and thechamber face side" on page 76

Clean the chamber, trays and the rack. See"Cleaning the chamber and the chamberaccessories" on page 77

Cleaning the chamber filters. See "Cleaning thechamber filter" on page 78

Cleaning the external surfaces of the sterilizer.See "Cleaning the external surfaces of thesterilizer" on page 80

6month 800 Clean both water tanks. See "800-cycle orbiannual maintenance" on page 83.

Yearly2 4002 Replace the bacteriological filter. See "400-cyclemaintenance" on page 81.

Replace the dust filter. See "400-cyclemaintenance" on page 81

Yearly2 8002 Replace the door seal. See "800-cyclemaintenance" on page 88.

5 years 4000 General check and service. See "4000 cycle orfive-year maintenance" on page 90.

Note 1: Whichever occurs first.

Note 2: Even if the maximum cycle number is not reached, it isrecommended to replace the consumable parts every year, or if theyappear worn or damaged, or if the filters are clogged or discolored.

EXPIRED MAINTENANCEA video animation is available on https://video.wh.com/en_global/dental-faq.

The sterilizer monitors the wear of consumables by counting thenumber of cycles executed since the last replacement.

When the number of cycles is close to the maximum, a pre-alertabout the concerned consumable is displayed. Please check thatyou have the requested spare part available, buy one if not. Whenthe maximum number of cycles has been met, a message toreplace the consumable will be displayed.

If you can not replace the consumable immediately, the sterilizerwill operate anyway but the message will appear again some cycleslater.

1 Tap to see an animatedreplacement procedure.

2 When you have replaced theconsumable tap to confirm: theexecuted cycle counter is reset.

https://video.wh.com/en_global/dental-faq/?page=1



Maintenance

REPLACE THE CONSUMABLE BEFORE THE MAINTENANCE DUEDATEIf you replace the consumables before the request of replacementappears, you should manually reset the counters through thefollowing procedure.

1 In the homepage tap >

2 Select the consumable you want toreplace: a message appearsshowing the current worked hoursof the part.

3 Tap to see an animatedreplacement procedure.

4 When you have replaced theconsumable tap to confirm: theexecuted cycle counter is reset.

Maintenance


Monthly or 50-cycle maintenance

CLEANING THE DOOR SEAL AND THE CHAMBER FACE SIDEProceed as follows:

1 Clean the seal seat and the chamber face side with a damp, lint-free clothmoistened with clean water.Notice:

Do not use abrasive products, cutting tools or sharp objects.

If you use a detergent solution, be careful not to get in contact with the plasticbody of the front cover.

2 Rinse with clean water.

Note: when the seal is new it might be necessary to hold the door gently closed at thesterilization start.

Maintenance


CLEANING THE CHAMBER AND THE CHAMBER ACCESSORIESProceed as follows:

1 Remove the trays and the chamber rack.

2 Clean the chamber with a damp sponge and a mild detergent solution payingattention not to bend or damage the temperature probe inside the sterilizerchamber.

3 Rinse with water.

4 Clean the trays and the chamber rack with a damp sponge and a mild detergentsolution.

5 Rinse with water.

6 Reposition all pieces of the chamber accessories properly.

Note: The trays and the tray holder may also be cleaned in a washer disinfector.

Maintenance


CLEANING THE CHAMBER FILTERProceed as follows:

1 Allow the sterilization chamber to cool down.

2 Empty the sterilizer chamber by removing the trays and the rack.

3 Turn the filter cap at the back of the chamber (bottom/center) counter-clockwise.

Maintenance


4 Remove the filter cap and the cartridge filter.

5 Rinse the cartridge filter with tap water.

6 Insert the cartridge filter in the filter cap.

7 Insert the filter cap with the cartridge filter in its original position.

Maintenance


8 Lock the filter cap by turning it clockwise.

CLEANING THE EXTERNAL SURFACES OF THE STERILIZERProceed as follows:

1 Clean all external sterilizer covers with a slightly damp cloth moistened withwater.Notice: Never use disinfectants, detergents or abrasive products.

Maintenance


400-cycle maintenance

REPLACING THE BACTERIOLOGICAL FILTERA video animation is available on https://video.wh.com/en_global/dental-faq.

Notice: If you replace this consumable before the maintenance due date you have to reset the cycle counter. See "Replace the consumablebefore the maintenance due date" on page 75.

Proceed as follows:

1 Open the service door.

2 Unscrew the bacteriological filter by hand (counter-clockwise).

3 Screw on the new bacteriological filter (clockwise) and tighten it snug.


Maintenance


REPLACING THE DUST FILTERA video animation is available on https://video.wh.com/en_global/dental-faq.


Proceed as follows:

1 Pull out the dust filter handle from underneath the sterilizer.

2 Lift the used filter from the handle and remove it.

3 Insert the new filter into the handle.


Maintenance


4 Slide the handle back into its original position.

800-cycle or biannual maintenance

SEQUENCE OF PROCEDURES TO CLEAN THE WATER TANKSTo clean the water tanks, proceed as follows:1. "Prepare the sterilizer for cleaning the water tanks" on the next page.2. "Access to the water tanks" on page 85.3. "Clean the water tanks" on page 86

Maintenance


PREPARE THE STERILIZER FOR CLEANING THE WATER TANKSA video animation is available on https://video.wh.com/en_global/dental-faq.

Proceed as follows:

1 Switch OFF the sterilizer and disconnect the mains cable.

2 Completely drain both water tanks (see "Draining the used and clean water tank"on page 91).

3 To drain the detergent solution during the subsequent cleaning, leave the draintube attached to the drain port of the tank you want to clean.


Maintenance


ACCESS TO THE WATER TANKSA video animation is available on https://video.wh.com/en_global/dental-faq.

Proceed as follows:

1 Lift the water tank cover.

2 Tap with your fingers on the rubber membrane to remove any condensate.

3 Remove the rubber membrane; clean and dry it.


Maintenance


CLEAN THE WATER TANKSA video animation is available on https://video.wh.com/en_global/dental-faq.

Notice: Do not touch the water level sensors. If misplaced or misaligned from their original position, the operation of the sterilizer could beimpaired.

Proceed as follows:

1 Clean the internal tank surfaces with a soft sponge and a mild detergent solution.Notice: Never use disinfectants, strong detergents or abrasive products. Use asmall non-abrasive brush to clean the areas that are difficult to reach.

2 Rinse the internal tank surfaces.

3 Wait until the drain tube has drained all the detergent solution and dry theinternal tank surfaces.

4 Detach the drain tube, attach it to the drain port of the other tank and repeatsteps 1, 2, 3.


Maintenance


5 Remove the internal filters.

6 Clean the metal cartridges of the internal filters with tap water.

7 Reposition the internal filters.

8 Reposition the rubber membrane and then the water tank cover.

9 Detach the drain tube.

Maintenance


800-cycle maintenance

REPLACING THE DOOR SEALA video animation is available on https://video.wh.com/en_global/dental-faq.


Proceed as follows:

1 Fully open the chamber door.

2 Remove the used door seal by hand.

3 Carefully clean the seal seat and the chamber face side with a damp, lint-freecloth.

4 Moisten the new seal with water to facilitate its placement.


Maintenance


5 Insert the new seal and press first up and down.

6 Press left and right and then the entire seal circumference to ensure its perfectplacement.Notice: A steam discharge can damage the sterilizer plastic parts. Ensure theseal does not stick out.

7 Wipe any residual water and run a Vacuum and Helix test to check for perfecttightness of the seal. See "Vacuum test" on page 51 and "Helix test" on page 48.


Maintenance

4000 cycle or five-year maintenance

GENERAL CHECK AND SERVICE REQUIREDNotice: Regular service is imperative to ensure continuous andeffective operation of the sterilizer.

A general check and service should be carried out every 4000cycles or five years by an authorized service technician. Theservice required includes the following:n the replacement of consumables and other important internal

componentsn a check of the entire sterilizer with special care for the safety

systemsn the cleaning of areas and components that cannot be

accessed by the user.

ACTIONS REQUIRED FOR EACH ELEMENTFor each element, the actions to carried out are the following:

Element Replace Clean Check

Solenoid valves x - -

Vacuum pump internal parts x - -

Sterilization chamber and external surfaces - x -

Chamber filter - x -

Element Replace Clean Check

Internal parts, with particular care for the condenser finsand the main board

- x -

Pneumatic connections - - x

Electrical connections - - x

Temperature and pressure calibration - - x

Door locking system - - x

Pressure safety valve - - x

Safety systems - - x

Maintenance


Extraordinary maintenance

DRAINING THE USED AND CLEAN WATER TANKIf you left accidentally the tanks full for more than seven days or if you plan not to use the sterilizer for at least seven days, you have to drainthe tanks.

1 Open the sterilizer service door.

2 Put a container below the sterilizer (4 l (1.06 gal) minimum) and place the end ofthe drain tube in it.

3 To drain the used water, insert the drain tube connector in the grey port.

4 To drain the clean water, insert the drain tube connector in the blue port.

5 When the water has been completely drained, press the release button to removethe drain tube and close the service door.

Maintenance


RESET THE SAFETY THERMOSTATThe sterilizer is fitted with a safety thermostat to prevent it from overheating. If the safety thermostat operates because of too hightemperatures, the error 240 or a timeout error is displayed. The thermostat must be reset manually. Proceed as follows:

1 Switch the sterilizer OFF and remove the mains cable.

2 Wait for the sterilizer to cool down.

3 Remove the dust filter and move the sterilizer closer to the shelf edge.

Maintenance


4 Push the reset button of the thermostat switch: a click sound indicates that thethermostat switch has been reset.

Maintenance


5 Insert the dust filter back into its original position.

6 Connect the mains cable and place the sterilizer back into its original position.

7 Switch the sterilizer ON.

8 Wait for the sterilizer to finish the error reset phase and follow the instructions onthe display.

Note: If the thermostat operates repeatedly, call technical service.

Maintenance


Battery-operated door opening tool

WARNING ABOUT OPENING THE DOOR IN EMERGENCY

WARNING! High pressure. Risk of explosion, jet of hot steam, sudden opening of the door. Execute the following procedure only ifnecessary and only when NO RESIDUAL PRESSURE IS IN THE CHAMBER. Any attempt to open the door while the unit is still hot or underpressure could expose the operator and the surrounding personnel to serious risk.

CAUTION! High temperature. Risk of burn. Execute the following procedure only when the sterilizer has completely cooled down.

Notice: Execute this procedure only as indicated and with the sterilizer in the indicated conditions. Any attempt to open the door in a differentway can seriously damage the sterilizer.

OPENING TOOLThe door locking system is electrically activated. In case the door remains locked due to a black-out or an electric fault, an auxiliary unlockingprocedure is available.

For this reason, two 9V batteries size PP3 or 1604 are required.

Maintenance


OPEN THE DOOR IN EMERGENCYA video animation is available on https://video.wh.com/en_global/dental-faq.

1 Unplug the sterilizer and wait at least three hours.

2 Extract the dust filter and remove the auxiliary cable loom.

3 Plug two batteries into the connectors.

4 Firmly open the service door.

5 Holding the service door pulled, plug the plastic connector into the socket behindthe bacteriological filter.

6 As soon as the door opens, unplug the plastic connector to prevent systemoverload and consequent damage.

7 Put the auxiliary cable loom back in the dust filter handle and insert the dustfilter in the sterilizer.


Maintenance


Disposal

DISPOSAL RESPONSIBILITY

n Separate the various components according to the materials they are made of.n Drop the sterilizer with a company that specializes on the recycling of related products.n Do not abandon the sterilizer in unsecured places.n Always refer to current/applicable laws and rules in the country of use.

The same instructions apply to disposal of all used consumable parts.

MATERIALSThe sterilizer is mainly built from fiber-reinforced polymers, metals and electric / electronic components.


Diagnostic


Errors 98Troubleshooting 103

Errors

CHECKS AND ACTIONSNotice: For any error not listed in this table, call technical service.

Code Description and actions Actions

0xx Load cannot be considered sterile. See "End of asterilization cycle" on page 63

Repeat the cycle.

If the problem persists, call service.

Check if the main switch or network circuit breaker is OFF.

Check if the mains cable is properly connected.

Switch the sterilizer OFF and ON.

Set date and time, then switch the sterilizer OFF and ON.

Check the dust filter and ensure that the sterilizer fan isnot blocked.

10x See error "13x to 16x" on the next page. Repeat the cycle.


Diagnostic



12x Wait before opening the chamber door. Allow thesterilization chamber to cool down. See error "13x to 16x"below.

Repeat the cycle.


13x to 16x Check water level in the clean water tank. Reset thethermal overload.

Repeat the cycle.



Clean the door seal and the chamber face side.

Check if the load placed in the sterilization chambercomplies with the MAXIMUM WEIGHT LIMITS.

Clean the chamber and the chamber furniture fromresiduals of detergents, disinfectants and otherchemicals.

Replace the clean water if it is suspected to becontaminated with chemicals.

Ensure all the load is clean rinsed and free from anychemicals before sterilizing.

Start a vacuum test to check the tightness of thepneumatic circuit.

18x Chamber filter clogged. Remove and clean the chamberfilter. See error "13x to 16x" above.

Repeat the cycle.


Bacteriological filter clogged. Check and replace ifnecessary.

19x Clean the door seal and the chamber face side. Repeat the cycle.


Diagnostic



2xx Switch the sterilizer OFF and ON. Repeat the cycle.

If the problem persists, call service.Wait for the chamber to cool down. Reset the thermaloverload (see "Extraordinary maintenance" on page 91).

3xx Check the door seal. Clean or replace it if necessary. Repeat the cycle.

If the problem persists, call service.Clean the chamber face side.

Clean the chamber filter.

Check if chamber filter is properly locked in the cap.

Check the load does not exceed the MAXIMUM WEIGHTLIMITS.

4xx Clean water error (bad quality or lowwater level). Drainand refill the clean water tank.

Repeat the cycle.


5xx Check if there are hurdles on the door locking area(chamber rack, loads, objects,…).

Repeat the cycle.


Check the door seal (wrong placed).

Check if the door canmove freely without touching thetrays or the load when closing.


990 The cycle has been aborted by the user. Re-process the load.

Diagnostic


MESSAGES AND ALERTSNotice: For any error not listed in this table, call technical service.

Message/Alert Description Action

Fill clean water tank. There is not enough water in the tank to perform acycle.

Fill the water tank as requested.

Drain used water tank. The used water tank is full. Drain the water tank as requested.

Please close the door. The door must be locked, but you didn't close it. Close the door so it can be locked.

Non-conform water The clean water quality is bad (conductivitybetween 15 and 50 μS/cm).

You may run a cycle but the water must be replaced soon, otherwise the unit willautomatically lock-out to prevent damage.

Water quality above limit The clean water quality is very bad (conductivitymore than 50 μS/cm).

Running a cycle is inhibited to prevent damage. Replace the clean water.

Door Gasket must be replaced in[*%%*] cycles.

Have you ordered the doorgasket?

These are pre-alerts advising that one of theconsumables has to be replaced within a smallnumber of cycles.

Tap if you have the consumable available for replacement.

Tap if you don't have the consumable in stock and must order one. In this case, thepre-alert will appear again after some cycles.

See "Maintenance" on page 73.

HEPA filter must be replaced in[*%%*] cycles.

Have you ordered the bact. filter?

Dust Filter must be replaced in[*%%*] cycles.

Have you ordered the dust filter?

[*T1*] cycle maintenance mustbe performed in [*%%*] cycles.

Have you already booked the[*T1*]-cycle service?

This pre-alert advises you that the target of 4000cycles is close and the relevant maintenance stepis to be scheduled.

Contact your Technical Service.

Diagnostic


Message/Alert Description Action

Possible leak detected.

Please run Vacuum Test.

Air was detected in the chamber: a vacuum leak issuspected. The cycle was completed but a vacuumtest is required.

Run a vacuum test.

Call for service if an anomaly is detected.

Remote data storage

Please check settings.

Error when saving the files in the network. Check the settings, the network resource and the memory space available on it.

Remote data storage

File lost.

Some cycle reports couldn't be saved in thenetwork because the sterilizer memory is limited(see "Sterilization cycle report" on page 65).

No action possible. The cycles were overwritten in the sterilizer database before beingsaved, and there is no way to recover them.

Door Gasket replacement is due.

Have you replaced the DoorGasket?

These messages advise that one consumablemust be replaced.

Replace the consumable and tap to reset the counter (See "Maintenance" onpage 73).

If you don't replace the consumable, press .

In this case, youmay still use the sterilizer but the message will appear again aftersome cycles.

CAUTION! Operating the sterilizer with expired consumables could bedangerous and could damage the sterilizer.

HEPA filter replacement is due..

Have you replaced the HEPAfilter?

Dust Filter replacement is due.

Have you replaced the DustFilter?

LISA has completed 4000 cycles.

Please call your technical supportto organize service.

This message advises you that the target of 4000cycles has been achieved and the relevantmaintenance step is to be performed.

Call technical service for the 4000 cycle maintenance.


Diagnostic

Troubleshooting

MANAGING ERRORSIf during a sterilization cycle an error occurs do the following:

1 Wait until the end of the resetphase.

CAUTION! Do not switch off thesterilizer during the resetphase: it takes some minutesto reset the system and reachsafe conditions in the sterilizerchamber.

2 When the OPEN button appears, tapit to unlock the door.

3 Confirm the opening of the door.

Notice: Water could be present in thechamber when opening the door:prevent spilling (e.g., place a towelbelow the chamber door).

VIEW AND SAVE THE ERROR LOG

1 In the homepage tap > >> : a list of the last errorsappears.

2 Tap to save the list in the USBpen drive.


Diagnostic

ERROR PAGEDuring the sterilization cycle, the sterilizer is continuouslymonitored by a control system. If an anomaly is detected, the cycleis aborted automatically, and the sterilizer starts a reset phase.

The following page appears:

Part Description

A Current sterilization cycle

B Error number, See "Errors"on page 98.

C Warning messages.

D Open button that appearsafter the reset phase hadfinished.

WARNING MESSAGES

Message Description

Load notsterile

The load is not sterile.

WARNING! Do not use items on patients!

Dryinginterrupted

The load might be wet.

WARNING! Wet items are for immediate use only!

Diagnostic


TROUBLESHOOTING TABLENotice: Before sending the sterilizer for technical service, remove the mains cable, empty both water tanks and use the original or appropriatepackaging.

Problem Possible cause Solutions

The sterilizer remains switchedOFF.

The main switch or network circuit breaker is OFF. Activate the main switch or network circuit breaker (ON).

No voltage at the socket. Check the electric circuit.

The power cord is not connected properly. Check and connect the power cord properly.

Water is leaking at the front of thesterilizer.

Leaks through the chamber door seal. Clean or replace the door seal.

Clean the chamber face side.

Internal leak. Call technical service.

The cycle commences but there isno pressure/temperature rise.

The thermal overload switch is open. Reset the thermal overload switch. See "Extraordinary maintenance" on page 91.

Electric - electronic fault. Call technical service.

At the end of the cycle, there isresidual water in the chamber.

Sterilizer not properly leveled. Properly level the surface the sterilizer is placed on.

Overloaded chamber. Comply with the maximum load weight limits for each type of load. Always use thechamber rack for trays and cassettes. See ."Load maintenance and preparation" onpage 53

Chamber filter clogged. Remove and clean the chamber filter.

Chamber filter cap not well-positioned. Mount the chamber filter cap properly (see "Ordinary maintenance" on page 74)

Load incorrectly placed. See "Load maintenance and preparation" on page 53

Diagnostic



Corrosion or spots oninstruments.

Tap water on instruments when placed in thesterilizer.

Ensure that instruments are dry before they are placed in the sterilizer.

Use of water of poor quality or water containingchemical substances.

Drain both water tanks. Use water of good quality. See "Water quality" on page 118.

Organic or chemical residues on the instruments. Clean, rinse and dry instruments before placing them in the sterilizer. See "Loadmaintenance and preparation" on page 53

Chamber, trays, chamber rack dirty. Clean the chamber and wash the chamber furniture.

Contact between instruments of different materials. Ensure that instruments of different materials do not touch (aluminum, carbon orstainless steel, etc.); place them on different trays or cassettes or pouch them. See"Load maintenance and preparation" on page 53

Scale deposits on the chamber. Clean the chamber and use water of good quality. See "Water quality" on page 118.

Instruments are turning brown orblack.

Incorrect temperature selected. Select a sterilization cycle featuring a lower sterilization temperature. Follow theinstructions of the instrument manufacturer.

The cycle report printer does notwork.

Printer not properly connected or not powered. Check the data and the power connection to the printer.

No cycles are stored in the cyclehistory menu.

An electronic board was replaced by service. None. The memory of the old board cannot be restored. Save periodically the history onthe USBpen drive.

When starting a cycle, thechamber door locks but re-opensimmediately. The “Open the door”message appears.

Door seal not properly placed; seal sticking out. Ensure that the door seal is evenly inserted on the entire circumference.

Door jammed by external objects or by the loaditself.

Remove any objects interfering with the chamber door. Check the door does not forceagainst the load or the chamber furniture.

Diagnostic



When the sterilizer is connectedto an automated water supplysystem: there is no clean water inthe tank, but the automaticwaterfilling does not fill the water

Water fill system not connected. Connect the water fill system to the sterilizer. See "Water quality" on page 118.

When the water fill system attempted to fill thetank, water was temporarily unavailable.

Since water tank filling is attempted only once in-between cycle execution, this eventinhibits water feeding. Switch the sterilizer OFF and then ON again.

Check the external water supply system.

Check for water leaks from the sterilizer.

Faulty MIN water level sensor in the clean watertank.

Call service.

The sterilizer enters into standbymode immediately after openingthe chamber door.

The chamber door has not been opened after theprevious cycle had finished and the standbymodedelay has expired.

Press the standby button to exit.

At the end of the cycle the displayreads “Open the door” butopening the door is impossible.

The chamber is in vacuum due to an internalmalfunction.

Switch the sterilizer OFF: this releases any internal pressures allowing the chamber doorto be opened. Call technical service if the problem persists.

The bacteriological filter is blocked. Remove the bacteriological filter to get the pressure released. Replace the filter.

Note: The bacteriological filters need to be replaced every 400 cycles.

The sterilization process phase ofa sterilization cycle was longerthan expected.

The chamber temperature dropped below theminimum threshold and the software performed asuccessful recovery.

Wait for cycle completion. If the problem occurs frequently, call technical service.

Warning about USB saving (HTMLand SCL files).

The USBpen drive is not connected or not properlyconnected to the sterilizer.

Check presence and connection of the USB pen drive.

If the problem persist, call service.

Warning about programmedmaintenance.

A component shall be replaced for the programmedmaintenance of the sterilizer.

Call service to order the requested component (door seal, dust filter, bacteriologicalfilter…).

See "Ordinary maintenance" on page 74


Technical data


Sterilization cycles 108Sterilization cycle phases 112Technical data 115Test validation points 116Diagrams 117Water quality 118Accessories, spare parts, consumables 119Authorized W&H service partners 122


WARNINGSFor your safety and for the safety of your patients:

WARNING!Never process objects different from those specified in the cycle program table and never exceed the maximum load weight limitsspecified in it as this could impair the sterilization process. Such actions could result in non-sterile conditions at the end of the cycle,could expose people to the hazard of cross-infections, are considered as an improper use of the sterilizer for which the manufacturercannot be hold responsible.All indications of sterile load or successful completion of the cycle that are given on the display at the end of the cycle are not valid ifthe type and quantity of the load are not complied with.Processing bagged items with the S Fast 134 cycle will result in wet bags/pouches at the end of the cycle, exposing the items tocontamination due to improper storage. The display reminds the maximum permitted load before starting a cycle.

Technical data


STANDARD STERILIZATION CYCLES AVAILABLEThere are four sterilization cycles available, all of them complying with the European Standard EN13060:n three B-type cyclesn one S-type cycle

Cycletype

Cycle name Purpose

B BUniversal134

For all your general items like hand instruments, handpieces, forceps, etc.

B Extended134

Features an extended sterilization time, if this is required for your load or mandated in your country.

B Universal121

For all items that cannot withstand the high temperatures of the 134 cycles, such as textiles and plastics.

S S Fast 134 For fast processing of unwrapped instruments only, including dental turbines and handpieces, solid, and hollow B (simple hollow items). It is not suitablefor textiles, porous or bagged/wrapped items.

After the cycle is completed, the sterilizer could perform two drainage periods of about 30 seconds each.

The instruments sterilized with this cycle cannot be stored: theymust be used immediately after being sterilized.

COMMON STERILIZATION CYCLE DATA


BUniversal 134 B Extended 134 BUniversal 121 S Fast 134

Sterilization temperature 134 °C (273 °F) 134 °C (273 °F) 121 °C (250 °F) 134 °C (273 °F )

Sterilization pressure 3.03 bar

2.03 bar (g)

3.03 bar

2.03 bar (g)

2.04 bar

1.04 bar (g)

3.03 bar

2.03 bar (g)

Duration of the Plateau/Sterilization phase 4' 18' 30" 15' 30" 3' 30"

Duration of the drying phase (ECODRY plus mode) 5'–16' 5'–16' 6'–24' 1' 20"

Technical data



BUniversal 134 B Extended 134 BUniversal 121 S Fast 134

Minimum duration of the drying phase (set by the user) 16' 16' 24' -

Load type All unwrapped, bagged, single/double wrapped items:n Solidn Hollow A (Narrow lumen)n Hollow B (simple hollow item)n Porous

Unwrapped items:n Solidn Hollow B

(simplehollowitem)

n Dental load(turbinesandhandpiecesfamily, ...)

TOTAL CYCLE DURATIONThe total cycle time includes the drying time and may vary according to different elements, such as the following:n type of load (solid or porous)n load weightn the duration of the drying phase (if the ECO DRY mode is disabled)n other factors

Values and cycle names could be different depending on country requirements.

Load

Empty Full Typical

LISA 17 LISA 22 LISA 17 LISA 22 LISA 17 LISA 22

BUniversal 134 21' 21' 44' 49' 30' 31'

B Extended 134 36' 36' 60' 64' 46' 47'

Technical data


BUniversal 121 36' 36' 60' 63' - -

S Fast 134 - - 13' 15' - -

Note: Values and cycle names could be different depending on country requirements.

MAXIMUM LOAD FOR INSTRUMENTSNote: The load given includes the trays, the containers and everything is put into the chamber, with the sole exclusion of the tray rack.

Instruments

Bagged Unwrapped Porous

LISA 17 LISA 22 LISA 17 LISA 22 LISA 17 LISA 22

BUniversal 134 4.5 kg (10 lbs) 6.0 kg (13.2 lbs) 4.5 kg (10 lbs) 6.0 kg (13.2 lbs) 1.5 kg (3.3 lbs) 2.0 kg (4.4 lbs)

B Extended 134 4.5 kg (10 lbs) 6.0 kg (13.2 lbs) 4.5 kg (10 lbs) 6.0 kg (13.2 lbs) 1.5 kg (3.3 lbs) 2.0 kg (4.4 lbs)

BUniversal 121 4.5 kg (10 lbs) 6.0 kg (13.2 lbs) 4.5 kg (10 lbs) 6.0 kg (13.2 lbs) 1.5 kg (3.3 lbs) 2.0 kg (4.4 lbs)

S Fast 134 - - 0.5 kg (1.1 lbs) 0.6 kg (1.3 lbs) - -

MAXIMUM LOAD FOR CONTAINERSThe correct dryness can only be obtained with the ECO DRY mode.

LISA 17 LISA 22

BUniversal 134 9.0 kg (19.8 lbs) 9.0 kg (19.8 lbs)

B Extended 134 9.0 kg (19.8 lbs) 9.0 kg (19.8 lbs)

BUniversal 121 not suitable not suitable

S Fast 134 not suitable not suitable

Technical data


Sterilization cycle phases

COMMON LEGEND OF THE STERILIZATION CYCLE PHASESFollowing is the description of the sterilization phases.

Code Description

PHE Pre-heating of the sterilizer. This phase is not considered a part of the cycle.

PV1 - PV3

PV1 - PV6

Vacuum pulse (removal of air from the sterilizer chamber/load)

PP1 - PP2

PP1 - PP5

Pressure pulse (steam generation)

PPH Rise to the Plateau/Sterilization phase

PR Process (Plateau/Sterilization phase)

DV Vacuum drying

SEP Short phase to clean the circuit from used water

LEV Leveling. Pressure inside the sterilization chamber is leveled to the atmospheric pressure.

END End of the cycle

Technical data


TYPE B STERILIZATION CYCLE PHASESAll type B sterilization cycles feature the same basic pressure profile as shown in the graph below. The duration and the temperaturesterilization phase differ between the various cycles.

Technical data


TYPE S STERILIZATION CYCLE PHASESThe S Fast 134 cycle is specifically designed to sterilize unwrapped instruments, for immediate use on patients, not requiring a completedrying. Thus, the drying phase of this cycle is short, making this cycle the fastest available.


Technical data

Technical data

WATER SUPPLY SYSTEM (TO BE COMPLIANT WITH IEC61770)Fitting Backflow preventing device (IEC61770).

Temperature max. 35 °C (95 °F)

Pressure min. 2 bar – max. 8.6 bar (min 29 psi - max. 124.7 psi)

Flow min. 0.25 – max. 0.5 l/min (min. 0.066 - max. 0.132 gal/min)

POWER SUPPLY SYSTEMNominal voltage and Max.current

200–240 V ac, 50/60 Hz, 10 A / 12A (refer to product label),single-phase

Overvoltage category II

Protection required Suitable circuit breaker and a Ground Fault Circuit Interrupter (GFCI).All protection devices must be certified according to applicablestandard. A grounded connection is essential.

Communication with otherdevices

3 USB port - 1 Ethernet port - 1 Serial port

Features Fullymicro-processor controlled, process evaluation systemaccording to EN13060.

Programmable standbymode.

Max. heat output 3000 kJ/h

Residual-current device 30 mA or less, if required by local regulations

Automatic circuit breaker(min.)

10 A (version labelled 10 A)

12 A (version labelled 12 A)

INSTALLATION REQUIREMENTSWorking temperature From +5 °C to +40 °C (from +41 °F to +104 °F)

Working relative humidity Max. RH 80% up to 31 °C (88 °F), linearly decreasing to 50% at 40°C (104 °F)

Storage temperature / rel.humidity

From -20 °C to +60 °C (from -4 °F to +140 °F )/0–90 % (with emptytanks)

Max altitude 3000 m asl

Min. atmospheric pressure 0.6 bar (8.7 psi)

Overall dimensions W: 465 mm/H: 449 mm/D: 599 mm (W: 18’’/H: 17.7’’/D: 23.6’’)

Min. space required W: 485 mm/H: 499 mm/D: 619 mm (W: 19.1’’/H: 19.6’’/D: 24.4’’)

Size of the door movement W: 410 mm/H: 400 mm/D: 360 mm (W: 16.1’’/H: 15.7’’/D: 14.2’’)

Weight empty LISA 17: 50.2 kg (110.7 lbs)

LISA 22: 51.7 kg (114 lbs)

Max. weight (fully loaded) LISA 17: 65.3 kg (143.9 lbs)

LISA 22: 66.8 kg (147.3 lbs)

Weight per support area LISA 17: 38.7 kN/m2

LISA 22: 39.8 kN/m2

Enviroment pollution Degree 2

STERILIZER CHAMBERPressure safety valve 2.6 bar (37.7 psig)

Safety thermostats 180 °C (356 °F)

Total volume LISA 17: 17 l/Ø: 250 mm/D: 362 mm (4.5 gal, Ø: 9.8’’/D: 14’’)

LISA 22: 22 l/Ø: 250 mm/D: 440 mm (5.8 gal, Ø: 9.8’’/D: 17’’)


Technical data

Usable space LISA 17: 11.5 l/W: 195 mm/H: 195 mm/D: 297 mm (3 gal/W:7.7’’/H: 7.7’’/D: 11.7’’)

LISA 22: 15 l/W: 195 mm/H: 195 mm/D: 390 mm (4 gal/W:7.7’’/H: 7.7’’/D: 15.4’’)

Bacteriological filter 0.3 µm

STEAM GENERATORPressure safety valve 4 bar (58.01 psig)

Safety thermostats 230 °C (446 °F)

DISTILLED OR DEMINERALIZED WATERWater quality Fulfilling EN 13060 Ann. C (conductivity < 15μS/cm)

Average water consumption 0.32 to 0.65 litres/cycle (0.08 to 0.17 gal/cycle)

Tank volume Clean water 4 l (1.06 gal)

Used water 3.5 l (0.92 gal)

Test validation points

RECOMMENDATIONS FOR VALIDATION

Part Description

Hottest points

Coldest points

For further details please refer to the Qualification/Validation guidefor sterilization cycles of W&H sterilizer.

Technical data


Diagrams

CONNECTION DIAGRAMS

Data communication Water system

Note (*): The water filtration system must be fitted with a backflow preventing device complying toIEC 61770 and to national and local regulations.

For water requirements see "Technical data" on page 115.


Technical data

Water quality

FEED WATER SPECIFICATIONS (EN 13060)Notice: Do not use rust inhibitor or any other agents in the cleanwater tank.

This sterilizer uses distilled or demineralized water to generatesteam for the sterilization process. The table below lists themaximum content of minerals and the specifications for the waterused for steam sterilization according to EN13060 ANNEX C.

Contaminants/minerals/qualities Value/Specification

Evaporate residue < 10mg/l

Silicon oxide, SiO2 < 1mg/l

Iron < 0.2mg/l

Cadmium <0.005mg/l

Lead < 0.05mg/l

Heavymetals (excl. iron,cadmium, lead)

< 0.1mg/l

Chloride < 2mg/l

Phosphate < 0.5mg/l

Conductivity (at 20°C) < 15 µs/cm

pH value 5–7

Contaminants/minerals/qualities Value/Specification

Appearance colorless, clean, free from sediment

Hardness < 0.02mmol/l

Chemical additives No chemicals or additives must be added to thewater used for the steam sterilization process,even if they are specifically claimed for use insteam generators, or for steam production, oras additives for sterilization, disinfection,cleaning or corrosion protection.

Notice:The use of water with a conductivity greater than 15μS/cm mayaffect the sterilization process and damage the sterilizer.The use of water with a conductivity greater than 50μS/cm, or notcomplying with the specifications in the table above, may stronglyaffect the sterilization process and seriously damage the sterilizer.The manufacturer’s warranty is void if the sterilizer was used withwater containing contaminant or chemical levels exceeding thoselisted in the table above.


Technical data

Accessories, spare parts, consumables

LIST OF ACCESSORIES AND SPARE PARTS

Picture PARTPart

number

Standard chamber rack for 3 cassettes/containers* for LISA 17

Cassette dimensions:n 190 x43 x300/375n 190 x43 x300/375n 190 x43 x300/375

F523008x



F523009x

Picture PARTPart

number

Standard chamber rack for 3 USA sizecassettes /containers* for LISA 17


F523020x

Standard chamber rack for 3 USA sizecassettes /containers* for LISA 22


F523021x

Standard chamber rack for 4 cassettes* forLISA 17

Cassette dimensions:n 190 x32 x300/375n 210 x32 x300/375n 210 x32 x300/375n 190 x32 x300/375

F523012x


Cassette dimensions:n 190 x32 x300/375n 210 x32 x300/375n 210 x32 x300/375n 190 x32 x300/375

F523015x


Technical data

Picture PARTPart

number

Standard chamber rack for 2 implant cassettes/containers* for LISA 17

Implant cassette dimensions:n 190 x70 x300/375n 190 x70 x300/375

F523016x

Standard chamber rack for 2 implant cassettes/containers* for LISA 22

Implant cassette dimensions:n 190 x70 x300/375n 190 x70 x300/375

F523017x

Aluminium tray for LISA 17 F523204x

Aluminium tray for LISA 22 F523205x

Tray holder F523001x

Drain tube kit with fittings A812110x

Drain tube S230900x

Mains cable U38011xx

Picture PARTPart

number

Ethernet cable, 3m A801500X

USBpen drive V000004X

External printer

Model: S'Print

19721108

Label printer LisaSafe (label printer only) 19721100

LisaSafe Connection Kit

Includes the following:n USB connection cablen 1 roll of 2100 labelsn 1wax/resin ribbonn activation code instructions

19721123

Dist - water distiller 19723101

Multidem C27 - water demineralizer 19723112


Technical data

Picture PARTPart

number

Osmo - water demineralizer (osmotic principle) 19723100

Safety bracket kit X051125X

Auxiliary cable loom F3721060

- Kit helix test (PCD plus 30 strips) T801003x

Note*: The rack, rotated 90°, accepts 5 standard aluminium trays.

CONSUMABLES

Picture PartPart

numberWhen replace it

Bacteriological filter W322400x 400 cycles

Door seal F460504x 800 cycles

Dust filter F364502x 400 cycles

Picture PartPart

numberWhen replace it

400-800 cycleconsumable kit

Components:n 1 door sealn 2 bacteriological

filtersn 2 dust filters

X050326x Refer to each singlecomponent above

- 250 helix strips T800205x Before stocks areexhausted

Technical data


Authorized W&H service partners

A list and a map with your nearest W&H service partner are availableat http://wh.com.

Alternatively, refer to the following addressees:

Great Britain

W&H UKLIMITED6 Stroud Wood Business Centre, Park Street, St. Albans, Herts AL2 2NJPhone: +44 1727 874990Fax: +44 1727 874628E-mail address: [email protected]

Hungary

FEJÉR-FOG KFT.Breznó köz 11, 1118 BudapestPhone: +36 17885391, +36 209381492Fax: +36 13198590E-mail address: [email protected]: http://www.fejerfog.hu

Turkey

W&H DENTAL TIC. LTD.ŞTI.Kısıklı Mah.Alemdağ Cad.No:59/2, 34692 İstanbulPhone: +90 216 505 88 40 - 15Fax: +90 216 216 505 88 43E-mail address: [email protected]

Serbia

COMMEX DOOKornelija Stankovića 31, 21000Novi SadPhone/Fax: 021/511 073– 021/511 075M: 063/ 526 949 - 063/77 87 427E-mail address: [email protected] , [email protected]: www.CommexDental.com

Spain,Portugal

WEHADENT IBERICA S.L.C/ Ciudad de Melilla,3, Bajo, E-46017 ValenciaPhone: +34 96 3532020Fax: +34 96 3532579E-mail address: [email protected]

Slovenia

Korum d.o.o.Brnčičeva ulica 13, 1231 Ljubljana-ČrnučePhone: 01 56 12 533E-mail address: [email protected]: www.korum.si

Interdent d.o.o.Opekarniška cesta 26, 3000 CeljePhone: 03 425 62 00E-mail address: [email protected]: www.interdent.cc

Russia

Сервисный центр представительства компанииW&H вРоссии, г.МоскваОбщество сограниченной ответственностью«ВестМед» (ООО«ВестМед»), 121087, г.Москва,Промышленный проезд,д. 5, стр. 1Тел. 8 (499) 993 01 43http://www.wh.com/ru_cis/

Technical data


Poland

W&H Poland Sp. z o.o.ul. Tukana 3b, 02-843WarszawaPhone: +48 22 3318005Fax: +48 22 3318001E-mail address: [email protected]

theNetherlands

Medieq ServiceStellingmolenstraat 100, NL – 1333 CN AlmerePhone: +31 (0) 6 202 47 385E-mail address: [email protected]

Italy

W&H ITALIA Srlvia Bolgara 2, I-24060 Brusaporto (BG)Phone: +39 035 666 39 11Fax: +39 035 666 39 77E-mail address: [email protected]

France

W&H FRANCE S.A.R.L.4, Rue Ettore Bugatti, F-67201 EckbolsheimPhone: +33 388 774796 [SAV]Fax: +33 388 774799E-mail address: [email protected]

Germany

W&H Deutschland GmbH Raiffeisenstraße 3b, D-83410 LaufenPhone: +49 8682 8967-0Fax: +49 8682 8967-11E-mail address: [email protected]

Austria

W&H Austria GmbHIgnaz-Glaser Straße 53, A-5111 BürmoosPhone: +43 6274 6236-239Fax: +43 6274 6236-890E-mail address: [email protected]

Danmark,Finland,Iceland,Norway,Egypt,Sweden,Lithuania,Latvia

W&H Nordic ABLinjalvägen 10E, S-187 66 TäbyPhone: +46 8 445 84 30Fax: +46 8 445 88 33E-mail address: service@w&hnordic.se

CzechRepublic

Dentamechanik s.r.o.U Pily 581, 370 01České BudějovicePhone: + 420 386 351 165Fax: +420 368 360 114E-mail address: [email protected]

Bulgaria

Ве и Ха България ЕООД (W&H BULGARIA Ltd.)91 Pirin Str., Office nr. 6, BG-1680 SofiaPhone: +359 (0)2 854 95 65, 854 95 66; 854 95 91Fax: +359 (0)2 854 95 90E-mail address: [email protected]

Japan

白水貿易株式会社

札幌営業所

〒064-0824札幌市中央区北4条西20丁目2番1号Nord 420BLD 1F011-616-5814011-616-5812

Technical data


Japan


東京支店

〒101-0052東京都千代田区神田小川町1-11千代田小川町クロスタ12F03-5217-461803-5217-4617

Japan


関東研修サービスセンター

〒336-0017さいたま市南区南浦和3-34-2048-884-3951048-884-3950

Japan


名古屋営業所

〒464-0075名古屋市千種区内山3-10-7今池セントラルビル2F052-733-1877052-733-1890

Japan


大阪営業所

〒532-0033大阪市淀川区新高1-1-1506-6396-440006-6396-4457

Japan


福岡営業所

〒812-0013福岡市博多区博多駅東2-18-30八重洲博多ビル5F092-432-4618092-432-4617

Switzerland

W&H CH-AGIndustriepark 9, CH-8610 Uster ZH,Phone: +41 43 4978484Fax: +41 43 4978488E-mail address: [email protected]

Belgium,Luxembourg

Lisa Service BeneluxDanny SpelmansPhone: +32 (0) 474 942 769E-mail address: [email protected]

Australia

A-DEC AUSTRALIA CO.INC.Unit 8, 5-9 Ricketty Street, Mascot NSW 2020Phone: +61 2 83324000Fax: +61 2 83324099E-mail address: [email protected]

New Zeland

Ivoclar Vivadent NZP.O. Box 5243, Wellesley Street, 12 Omega Street, AucklandPhone: +64 9 914 9999Fax: +64 9 914 9958E-mail address: [email protected]

Documentation forms



W&H installation check-list 125Helix test documentation form 128

W&H installation check-list

QUESTIONS

N. Question Answer

Responsibility

1 Was the head of the clinic/practice present during all the in-service?

Yes No

Packaging and content

2 Is the packaging of the sterilizer undamaged? Yes No

3 When unpacked, is the sterilizer undamaged? Yes No

4 Are all the contents of the package available (sterilizer ship-with)?

Yes No

5 Are all the ordered accessories available with the sterilizer? Yes No

N. Question Answer

6 Have you removed all the protection covers from the sterilizerand from all the ship-with?

Yes No

Completeness of the Instructions for use

7 Were all sections of the instructions for use of the sterilizercovered and explained during the in-service?

Yes No

Workplace suitability

8 Is the allocated countertop for the sterilizer levelled and flat? Yes No

9 Are the recommended ventilation indications of the allocated areafor the sterilizer respected?

Yes No

10 Are the required minimum clearances respected? Yes No

11 Have you explained which water quality is required for the use ofthe sterilizer? Check and measure the μS of the water.

Yes No

Involvement of the Head of the clinic/pratice

12 Have you showed the Head of the clinic/practice the procedure forfilling and draining the main and used water tanks?

Yes No

13 Have you showed the Head of the clinic/practice how to programthe sterilizer?

Yes No

14 Have you showed the Head of the clinic/practice the cycleoptions?

Yes No

15 Have you showed the Head of the clinic/practice what themessages and alarms mean?

Yes No


Documentation forms

N. Question Answer

16 Have you showed the Head of the clinic/practice how to manuallyabort a cycle?

Yes No

17 Have you showed the Head of the clinic/practice the maintenanceprogram and procedures?

Yes No

18 Have you showed the Head of the clinic/practice how to use all ofthe accessories?

Yes No

19 Have you showed the Head of the clinic/practice the advantagesof having a USB connection for a pen drive?

Yes No

20 Have you showed the Head of the clinic/practice the advantagesof having a LAN connection?

Yes No

21 Have you suggested to the Head of the clinic/practice toperiodically backup the data, stored on the USBpen drive and/orin a PC, on another safe support?

Yes No

22 Have you showed the head of the clinic/practice the advantagesof having a Wi-Fi connection (remote data saving)?

Yes No

23 Have you explained to the head of the clinic/practice the correctload type for each available sterilization program?

Yes No

24 Have you showed the head of the clinic/practice how to prepareand place the load in the sterilizer chamber?

Yes No

25 Have you explained to the head of the clinic/practice to use onlyoriginal parts and accessories on the sterilizer?

Yes No

26 Have you showed and explained to the head of the clinic/practicethe safety advise section?

Yes No

Check

27 Have you executed a Vacuum test? Yes No

N. Question Answer

28 Have you executed a BUniversal 134 cycle program with the trayrack and trays inserted?

Yes No

29 Are all connections to the sterilizer well positioned and plugged(accessories, etc…)?

Yes No

INSTALLATION INFORMATION

VA131 Serial Number:

Date:

Purchased from:

Installed by:

Dr./Clinic name:

Address:

Phone:

Receiver's signature:

Installer's signature:


Documentation forms

ADDRESSES FOR SENDING THE INSTALLATION CHECK-LISTSend a copy of the compiled installation check-list to both of thefollowing addresses:

Fax: +43 6274 6236-55

Mail Ignaz-Glaser-Straße 53, Postfach 15111 BürmoosAustria

Documentation forms


Helix test documentation form

INSTRUCTIONSUse this page to create a logbook tracing the effectiveness of the sterilization cycle during the whole lifespan of your sterilizer.

FORM

Date Cycle n. Operator Released Signature Chemical indicator

Yes No

Yes No

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Yes No

Documentation forms



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Documentation forms



Yes No

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Yes No

ManufacturerW&H Sterilization Srlvia Bolgara, 2Brusaporto (BG)Italy

www.wh.com+39 035 66 63 000

VA131Instructions for use

ENGRev. 05

31/07/2018Subject to changes

va131 instructions for use eng rev. 05 · lisa |instructionsforuse| va131engrev.05| 31/07/2018|...

Documents