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ANNEX 9. Example of a traceability label

LISA 17

131685

02.01.10.00.11

Rel eased:

El i sabeth

Cycl e:

Uni versal 134

Number:

00261

Date:

16/11/2015 10:33

E x p i r y D a t e :

1 5 / 0 2 / 2 0 1 6

C C 1 D 6 4 0 0 0 2 6 1

Sterilizer model

Cycle name

Date and time of cycle start

Depending on the traceability settings (see TRACEABILITY),
this field may contain:
- the user who released the cycle, or
- the user who started the cycle, or
- the sterilizer ID

Serial number

Software release

Expiry date of the bag / package.
If a STORAGE TIME was not set (see LABEL PRINTING OPTIONS),
this field shows the cycle outcome.

Traceability code (bar code)

Traceability code (alphanumerical)

Cycle number

Содержание Lisq VA131-17

Страница 1: ...Posizione logo Instructions for use VA131 17 VA131 22 VA131 ENG Rev 4 ...

Страница 2: ...Risk of injury ATTENTION To prevent damageoccurring Generalexplanations without risk to personsor objects HOT SURFACES Risk of burns Thermo washer disinfectable Symbols 2 HOT STEAM Risk of burns Call service Consult instruction for use Do not disposeof with normal waste ...

Страница 3: ...nance 58 9 Troubleshooting Errors Messages and Alerts 67 10 Recycling and disposal 76 ANNEXES 1 Technical data 77 2 Maintenance of dental handpieces 78 3 Sterilization load preparation 79 4 Bowie Dick test 81 5 Helix test 82 6 Vacuum test 83 7 Water quality 84 8 Example of a cycle data report 85 9 Example of a traceability label 86 10 Accessories and spare parts 87 11 Helix test documentation form...

Страница 4: ... in Table 1 of the reference technical norm EN 13060 These loads include solid porous hollow loads type A and hollow loads type B unwrapped single wrapped and double wrapped LISA sterilizers cannot be used to sterilize liquids or pharmaceutical products About this manual This manual contains the Instructions for Use of the W H sterilizers VA131 17 and VA131 22 hereinafter referred to as LISA 17 an...

Страница 5: ... the ADMINISTRATOR instructions They must be trained in operating the sterilizerand in its safe use Training must be regular and evidenceof the understandingshall be recorded Conformity to European Standards and Directives MedicalDevice Directive 93 42 CEEfor devices class IIb in accordancewith the Rule 15 ANNEX IX of the aboveDirective Directive 97 23 CEE PED Pressure EquipmentDirective for every...

Страница 6: ...ionsof the box and the sterilizer In case of any damage immediatelycontact your dealeror the shipping agent that has carried out the transport Openthe front door All the accessoriesare in the sterilizationchamber Removeall items exceptthe trays and the tray rack 6 The packaging ofthe product is environmentallyfriendly and can bedisposedof by industrial recycling companies However we recommendto ke...

Страница 7: ...tents of the package Tray 5 piecestotal Reversiblerack Tray holder Drain tube Mains cable 7 USBpen drive Fast guide Declarationofconformity DocumentationCD Warranty card Works testsreport Maintenance sheet ...

Страница 8: ...holders to emptythe sterilizationchamber Do not exceedthe maximum load weight limits as specifiedin this manual seeChapter8 Do not remove the name plateor any labelfrom the sterilizer To avoid electricalshort circuits do not pourwater or any otherliquids over the sterilizer Use only the powercord set providedby the manufacturer Switch off the sterilizerand unplug the mains cable beforeinspecting c...

Страница 9: ...sive atmospheres Electrical connection The electrical power supply to the sterilizer must fulfil all applicable standards in the country of use and must comply with the data label on the back of the sterilizer Connect the cord set to the socket provided in the back of the sterilizer Use only the cord set provided by the manufacturer The power plug must be connected to a wall socket complying with ...

Страница 10: ...Openthe service doorat the front of the sterilizer Put a container 4 litres min belowthe sterilizerand insert into it the free end of the drain tube Insert the drain tube into the left connector grey for the used water or into the right connector blue for the clean water Let the water flow from the tank completely Press the push buttonon top of the quick connectorto dislodgethe drain tube Use only...

Страница 11: ... the chamber LISA 17 195x 195 x 297mm WxHxD equalto the volume of 11 5litres LISA 22 195x 195 x 390mm WxHxD equalto the volume of 15 litres Beforetouching the chamberfurniture ensure the sterilizationchamberis cold risk of burns The chamber rack is reversible and can accommodate5 trays horizontallyor 3 cassettes containers vertically If insertedin a 90 rotatedposition the rack holds 3 trays or3 ca...

Страница 12: ...ce door 12 Mains switch Bacteriologicalfilter Used water drain grey Clean water drain blue Touch screen Water tank cover Tank fillingcover cap Door pin Sterilizationchamber Door seal Chamber door Dust filter Servicedoor USB port Identificationlabel ...

Страница 13: ...ed in ANNEX 7 Do not add any chemical additive to the water The manufacturer s warranty is void if the sterilizer was used with water containing either chemical additives or contaminant levels exceeding those listed in ANNEX 7 The water supply system must be fitted with a backflow preventing device complying to IEC 61770 and to national and local regulations Maximum pressure 8 6 bar minimum flow 2...

Страница 14: ... and the sterilizerchamberis no longer heatedto save energy You may enablethe sterilizerto enterthe SLEEP modeautomaticallyafter beingleft unattendedfor a certain periodof time Touch in sequenceMENU SETTINGS ENERGY MANAGEMENT seeLIST OF MENU OPTIONS in the further pages To exit the SLEEP mode Touch the SLEEP buttonon the screen or Openor if it is open close the chamberdoor Controls and commands To...

Страница 15: ... and so on HEADER Shows the title purposeof the screenor the cycle numberand the current dateand time TYPICAL SELECTION SCREEN example CYCLE SELECTION SCREEN HOME screen Touch screen and Commands By touching an icon you selectan itemin the menu or undertake an action NOTE An icon in grey colour means that the relevant function is disabled 15 ...

Страница 16: ...t dateand time DATA ENTERING FIELD shows the letters numbersyou are typing SPECIAL KEYS see table FOOTER Shows the CONFIRMand BACK icons TYPING FIELD touch a key to type into the data enteringfield 16 KEY WHAT IT DOES Activates capital letters Cancels the last letter number typed Activates number keyboard Activates letter keyboard Space ...

Страница 17: ...touching the icons SCROLLUP SCROLLDOWN in the footer Someauxiliary functions are also availablein the footer like BACK HOME etc TYPICAL SCREEN TO SET PARAMETERS example date and time setting If you want to change a numeric setting e g the current hour simplytouch it Its colour turns green and a green frame appears the UP and DOWN icons appearto permit changing the value If the parameteris a settin...

Страница 18: ...e next page if any HOME Moves to the CYCLE SELECTION screen HOME screen MENU Accesses to the sub menus SETTINGS Provides access to the SETTING screen of a specific area e g cycle settings connettivity settings etc INFO Shows the INFO screen list of all operating parameters of the sterilizer OTHER SETTINGS Opens a screen with other settings options Active selection frame CONFIRM YES Confirms the ac...

Страница 19: ...KED UNLOCKING The door is unlocked You may open the door Also appears during unlocking you may hear the motor working wait DAILY PROGRAMMABLE CYCLE START Enters the function to program a succession of cycles for daily repetition ON OFF SWITCH These switch looking icons are used to set an option ON or OFF Touch to change the status OPTION STATUS Empty dot the option is inactive Filled dot the optio...

Страница 20: ...he time before the sterilizer will enter the SLEEP mode Use the UP and DOWN keys to set Sets the display brightness Touch the UP or DOWN button to increase or decrease the value Permits to choose between melodiesand beeptones If disabled only the sounds requested by mandatory standards are enabled error start cycle end cycle etc If enalbled all sounds are enabled Select the cycles that shall be av...

Страница 21: ... connection to a network is set Provides informationabout the status of the network Sets the parameters of the network location where the data have to be saved Copies all the files from the sterilizermemory to the specifiedlocation in the network Performs a sequence of tests to check if the files may be copiedto the specifiedlocation 21 List of the MENU options Continued from the previous page ...

Страница 22: ... See the USER MANAGEMENT section Programs a safe storage time in weeks of the wrappedsterilizeditems This option when activated allows the automatic printing of labels after the sterilizerhas completeda successful sterilization cycle When this option is activated after every successful sterilization cyclea screen appears permitting to set the number of labels to be printed Permits the ADMINISTRATO...

Страница 23: ...ress of the other sterilizerwill be requested Select the printer model connected to the sterilizer Permits entering the codes issued by the manufacturer to activate specialfunctions Displays the status of consumables numberof cycles executed and number of cycles left Resets the counter to zero after replacinga consumable See the MAINTENANCEsection for details Plays a video showing how to replaceth...

Страница 24: ...parameterssuch as date time language displaybacklight and contrast sound energy managementand sterilizername Fromthe CYCLE SELECTIONscreen HOME screen selectMENU SETTINGS DEVICE then set the parametersfollowing the icons in the page Go to the secondpage to set up further parameters ...

Страница 25: ...an be set dynamic configuration this is the default optionand is applicableto most LANs No further configuration is required staticconfiguration this optionmust be chosen when requestedby the characteristics of the network and requiresthe supportof the Administratorof the networkor the IT manager Seenext page Connection to the LAN Connection via Wi Fi Connect the donglekey to a USBport Followthe i...

Страница 26: ... enablesthe data fields theyturn to dark grey This opensa numeric keyboardscreen permittingto enterthe IP numbers NOTE If you don t have the IP numbers ask your IT Manager Administrator Touch the CONFIRMicon aftercompletingeach datafield NOTES Then touch each data field data fields containing invalid data appearin a darkgrey frame data fields containing VALID data appearin a greenframe ...

Страница 27: ...deleteusers reset the PIN codeof a user the initial value of all PINs after beingcreatedor reset is 0000 and must be changed by the user change your own PIN code If you log in as a user you only may change your own PIN code othericons are disabledor missing After operatingas the ADMINISTRATOR go backto the CYCLE SELECTIONscreen HOME screen you will be automaticallylogged out to prevent changes fro...

Страница 28: ...nd SelectRESETUSER PIN CODE and choosethe user from the list In the next screen touch CONFIRM The PIN codeis now resetto 0000 The user has to access and change his own PIN code To reset a user s PIN code Fromthe CYCLE SELECTIONscreen HOME screen select MENU TRACEABILITY USERMANAGEMENT and log in as the ADMINISTRATOR NOTE The PIN code of the new user is set to 0000 The new user has to access and ch...

Страница 29: ...29 User Management ADMINISTRATOR only Continued To delete a user In the selectionscreen select the user you want to deleteand confirm the further step ...

Страница 30: ...ou have ADMINISTRATORauthority you will seeothericons in additionto this one Selectthe optionCHANGE YOUR PIN CODE This activatesthe numeric keyboard enteryour new PIN code and confirm IN CASE A PIN CODE IS LOST FORGOTTEN Contact the ADMINISTRATORto resetyour PIN code to 0000 then change it If you are the ADMINISTRATORand you lost your PIN code contact the technical service ...

Страница 31: ...ionwill be requestedto start a cycle user name username and PIN code or disabled IDENTIFICATIONAT CYCLE END sets which informationwill be requestedat the end of a cycle user name user name and PIN code or disabled CONFIRMLOAD RELEASE At the end of the cycle the identifieduser must check the load and releaseit as valid Fromthe CYCLE SELECTIONscreen HOME screen select MENU TRACEABILITY and log in wi...

Страница 32: ...ELECTIONscreen HOME screen select MENU SETTINGS CYCLE CYCLE EXCLUSION NOTE you will have to enterthe ADMINISTRATOR spassword Cycle Exclusion ADMINISTRATOR only Enable or disablethe cycles that appearon the CYCLE SELECTIONscreen HOME screen by touching the relevant switch icon ...

Страница 33: ...the modelof cycle report printerconnected Fromthe CYCLE SELECTIONscreen HOME screen select MENU ACCESSORIES PRINTER A selectionscreenopens select the model of the printerconnectedfrom the list For a typical cycle reportprintout see ANNEX 8 33 ...

Страница 34: ...IBRATION the printer automatically locates the edge of the label to center the printout properly in the label area Horizontal X and vertical Y offsets Use this option only when the printout even after calibration is not duly centered in the label area NOTE Setting the offsets is only possible from the sterilizer to which the printer is set as local If you selected SHARED PRINTER you have to choose...

Страница 35: ...l the pages and take note of the IP address Ethernet or Wi Fi depending on the LAN connection Do not switch OFF the sterilizer until the whole procedure is complete In the next screen touch the blank field and enter using the numeric keypad the IP address previously noted Then press the TEST button Go back to the sterilizer to which the printer is connected and confirm the printer will be shared T...

Страница 36: ...s value is set to zero no expiring date is printed NOTE The labels are printed only after the user has identified him herself with password if required and the load has been checked and released if these options have been enabled by the ADMINISTRATOR For your safety and the safety of your patients Use a storage time according to the recommendations of the manufacturers of the containers packaging ...

Страница 37: ...ed Formattingerasesall data from the pen drive Be sure you alreadysavedyou dataon a safe supportbeforeformatting Lisa sterilizers are equippedwith a digital cycle data recordingsystem All data are recorded on the removable rewritable USB pen drive For details about the data that are saved and the file formats seeChapter7 CYCLE HISTORY The USB connectionfor the pendrive is located in the front behi...

Страница 38: ... displayed The SETTINGS icon permits to activate the remote storage and to set the necessary parameters The SAVE ALL icon permits to save on the network all the cycles stored in the sterilizer memory NOTE only the last 400 cycles will be saved 50 if in SCL mode The TEST icon permits to check if the remote storage is possible with the parameters given See the next two pages for a description of the...

Страница 39: ... credentials are required to access the remote storage location This will enable the USER and PASSWORD data fields Touch the CONFIRM icon when finished The path consists of the name of the shared folder followed by the sub folders if any and NOT the full Windows path The host name and the IP address are alternative either the first or the second one The domain name is not mandatory The fields rema...

Страница 40: ... is automatically performed see below The sterilizer attempts to access the specified location to check if the parameters entered are valid Positive tests are marked with a green checkmark If some tests are negative a red cross is displayed see example Touch the BACK icon when finished If you want to repeat the test touch the REPEAT icon ...

Страница 41: ...olid and hollow B It is not suitablefor textiles porous or bagged wrappeditems The instruments sterilizedwith this cycle cannot be stored they must be used immediatelyafterbeing sterilized 5 The available sterilization cycles 41 In totalthere are four sterilizationcycles available all of them complyingwith the EuropeanStandardEN13060 three B type cycles one S type cycle For your safety and the saf...

Страница 42: ... 47 36 63 15 LOAD TYPE Full porous 80 of the usable space YES YES YES NO Smallporous items gauze cotton YES YES YES NO HollowA forceps scissors YES YES YES NO Bagged single doublewrapped YES YES YES NO Unwrapped items YES YES YES YES Full solid probes tweezers burs YES YES YES YES Dental load turbines and handpieces family YES YES YES YES HollowB vacuum tips YES YES YES YES MAX LOAD bagged unbagge...

Страница 43: ...o the hazard of cross infections are consideredas an improperuse of the sterilizerfor which the manufacturer cannot be hold responsible Special recommendations for the cycle Processingbaggeditems with the cycle will result in wet bags pouches at the end of the cycle exposing the items to contaminationdue to improperstorage All indications of sterile load or successful completion of the cycle that ...

Страница 44: ...rilization phase PR Process sterilization phase DV Vacuum drying SEP Short phase to clean the circuit from used water LEV Levelling END End of the cycle 44 All type B sterilizationcycles feature the same basicpressureprofile as shown in the graph below The duration and the temperaturesterilizationphasediffer betweenthe various cycles Pressure Fractionated pre vacuum Pulsed vacuum drying LEV SEP EN...

Страница 45: ...terilization phase DRY Depressurization LEV Levelling END End of the cycle 45 The cycle is specifically designedto sterilize unwrappedinstruments for immediateuse on patients not requiring a completedrying Thus the drying phaseof this cycle is short making this cycle the fastestavailable Profile of a Type S sterilization cycle Fractionated pre vacuum Sterilization Drying Pressure rise LEV PV1 PP5 ...

Страница 46: ...vant icon After touching the START icon If you want to program the cycle for a delayed start to customize some parameters or make any other special choice check CUSTOMIZATION OF CYCLE SETTINGS ahead in this manual In the further screen touch the CYCLE START icon This starts the cycle immediately the door locks automatically the symbol appears in the top right corner NOTE If the door seal is new it...

Страница 47: ...nt cycle Cycle counter Current chamberpressure Padlockicon Indicates that the dooris securely locked Countdown approximateresidualtime until cycle completion Current chambertemperature Go to the INFO screen Current dateand time Manual Stopbutton Progress disc Eco Dry plus optionactive Cycle in progress ...

Страница 48: ...he main cycle parameters in real time The INFO screen The list is made of several pages Scroll them with BACK and NEXT On the CYCLE IN PROGRESS screen touch the INFO icon NOTE BACK on the first page redirects to the previous screen The INFO screen is displayed ...

Страница 49: ... the internal fittings as long as they are hot Use the tray holder or cassette holder to remove the load Special notes for the cycle After the cycle is completed the sterilizer could perform two short drainage periods about 30 seconds each During this operation the message DRAINING is displayed It is possible to launch a new sterilization cycle even if the two drainage periods have not been perfor...

Страница 50: ...terile Do not use items on patients the message DRYING INTERRUPTED means that the load might be wet Wet items are for immediate use only Check the WARNING MESSAGE By the INFO icon you may display the INFO screen see RUNNING A STERILIZATION CYCLE Do not switch off the sterilizer during the reset phase it takes some time to reset the system and reach safe conditions in the sterilizer chamber Water c...

Страница 51: ...ou to save time energy and money and works fully automatic Customization of cycle settings ECO DRY The ECO DRY default settings are suitable for most loadsand do not require to bechanged If you want to customizesuch settings beforeinitiating a cycle Selectthe cycle by pressingthe relevant icon and then touch the SETTINGSicon This opensthe CYCLE SETTINGSscreen In the toparea of this screen chooseth...

Страница 52: ...d of loads require an extendeddrying time FIXED DRY The ECO DRY modeis disabled The drying time is fixed the value is set by the user Touch the numberto set the time a screenwill appearfor this purpose NOTE The minimum value for the drying time is shown in the cycle programtable Special recommendation for small loads To enjoy the full benefit of short cycle times always place the loadon the uppert...

Страница 53: ...n cycle early the next morning before office hours It is possible to set both the date and the time in which the selected cycle s will start Load the chamber close the chamber door and choose the cycle you want to launch Touch this button to enable the delayed cycle Touch the date and time fields to change the values the UP and DOWN buttons appear In the CYCLE SETTINGS screen The screen displays t...

Страница 54: ...nceof two cycles e g if you want to run a vacuum test plus a HELIX test in the early morning before office hours Load the chamber and close the chamberdoor Fromthe CYCLE SELECTIONscreen HOME screen select MENU SETTINGS CYCLES DAILY PROGRAMMABLE CYCLE START This opensthe ADD CYCLE screen ...

Страница 55: ...nlist Touch the ADD icon to addanothercycle you may program2 cycles max Touch the BACK icon when finished you go back to the previous screen Touch the date timearea to openthe DATE AND TIME SETTINGSscreen Touch any figure to change the setting Touch the BACK icon when finished you go back to the previous screen Touch the GO icon to launch the programmedsequence Touch the BACK icon to exit Programm...

Страница 56: ...a further confirmation will be requested NOTE only the last 400 cycles will be copied in HTML format and the last 50 in SCL format See next page for further options from the CYCLE REPORT screen NOTE the sterilizer stores in memory the summarized reports of the last 400 cycles in HTML format and the analytical reports of the last 50 cycles in SCL format all parameters recorded every second All repo...

Страница 57: ... cycle reporton paper Save the cycle reporton the USBpendrive Print traceabilitylabelsfor the selectedcycle For this purpose a new screenopens If enabled REMEMBERNEXT TIME permits to reuse the last value as the default Set the number of labelsto beprinted Print the selectednumberof labels Fromthe next screen you have further choices ...

Страница 58: ...n Consumable Performed by Monthly 50 Clean the door seal and the chamber face side None User Clean the chamber trays and the rack Clean the chamber filter Clean the external sterilizer surfaces See note 400 Replace the bacteriological filter See ANNEX 10 Replace the dust filter 6 month 800 Clean both water tanks None See note 800 Replace the door seal See ANNEX 10 5 years 4000 General check and se...

Страница 59: ...EMIND ME LATER in this case anotheralert will appearafter somecycles Resetting the maintenance counters The VIDEO icon starts a videoanimationshowing how to proceed The animationis also availableon WH comFAQ videos When one counter reaches the maximum a requestof replacementis displayed Touch the CONFIRMicon afterreplacing the part This actionresetsthe counterto zero Touch the DO NOT CONFIRMicon i...

Страница 60: ...setthe counter to zero Resetting the maintenance counters from the main menu In the next screen you seea descriptionof the consumable the maximum number of cycles and the number of cycles performed the VIDEO icon starts a video animationshowing you how to proceed Then selectthe consumableto be replaced e g the bacteriologicalfilter Fromthe CYCLE SELECTIONscreen HOME screen select MENU MAINTENANCE ...

Страница 61: ... orsharp objects Cleaning the chamber and the chamber accessories Removethe trays and the chamberrack seesection ChamberFurniture in Chapter4 Cleanthe chamberwith a damp spongeand a mild detergentsolutionpaying attentionnot to bendor damage the temperatureprobeinside the sterilizer chamber Rinse with water Cleanthe trays and the tray rack with a damp spongeand a mild detergent solution Rinse with ...

Страница 62: ...ter clockwise 3 Removethe cartridge filter and rinse it with tap water 4 5 6 Insert the filter in the cap attach the filter cap and lock it by turning clockwise Cleaning the external surfaces of the sterilizer Cleanall externalsterilizercovers with a slightly damp cloth moistenedwith water Never use disinfectants detergentsor abrasiveproducts Monthly or 50 cycle maintenance ...

Страница 63: ...filter from underneaththe sterilizer Detachthe used filter from the handle Attach the new filter to the handle Slidethe filter back into its original position Rememberto reset the counter afterreplacement seeRESETTINGTHE MAINTENANCE COUNTERS Rememberto reset the counter afterreplacement seeRESETTINGTHE MAINTENANCE COUNTERS Seevideoanimation directlyon Lisa display Also on WH comFAQvideos Seevideoa...

Страница 64: ...ces with a soft sponge and a mild detergent solution then rinse and dry them Make sure the drain tube is connected to the tank you are cleaning left tank grey colored connector right tank blue colored connector to drain the detergent solution Only when both tanks are clean remove the internal filters see picture clean the metal cartridges with tap water and put them back into their position Reposi...

Страница 65: ...t the new sealin the sequenceas illustratedin the pictures to the left Completethe operationby evenly inserting the sealon the entire circumference ensure the sealdoesnot stick out no bumps ordeformations 800 cycle maintenance Rememberto reset the counter afterreplacement seeRESETTINGTHE MAINTENANCE COUNTERS Beforeusing the sterilizer wipe any residualwater and check for perfect tightness of the s...

Страница 66: ...system Pressure safetyvalve Safetysystems Regularservice is imperativeto ensure continuous and effectiveoperationof the sterilizer It is recommendedto carry out a generalservice every 4000cycles or five years by an authorizedservice technician The service includes replacementof consumablesand otherimportantinternal components a check of the entire unit with specialcare for the safetysystems and cl...

Страница 67: ...be presentin the chamberwhen openingthe door prevent spilling e g place a towelbelowthe chamberdoor At the end of the resetphase you may openthe door the messageLOAD NOT STERILEmeans that the load is not sterile Do not use items on patients the messageDRYING INTERRUPTEDmeans that the load might be wet Wetitems are for immediateuse only 9 Troubleshooting Errors Messages and Alerts The following inf...

Страница 68: ...or Allow the sterilization chamber to cool down See error 13X 16X 13X 16X Check water level in the clean water tank Reset the thermal overload Switch the sterilizer OFF and ON Clean the door seal and the chamber face side Check if the load placed in the sterilization chamber complies with the MAXIMUM WEIGHT LIMITS Clean the chamber and the chamber furniture from residuals of detergents disinfectan...

Страница 69: ... side Clean the chamber filter Check if chamber filter is properly locked in the cap Check the load does not exceed the MAXIMUM WEIGHT LIMITS 4xx Clean water error bad quality or low water level Drain and refill the clean water tank 5xx Check if there are hurdles on the door locking area chamber rack loads objects Check the door seal wrong placed Check the door can move freely without touching the...

Страница 70: ...y is very bad conductivity more than 50 µS cm Running a cycle is inhibited to prevent damage Replace the clean water These are pre alerts advising that one of the consumables has to be replaced within a small number of cycles Press CONFIRM if you have the consumable available for replacement Press NO if you don t have the consumable in stock and must order one In this case the pre alert will appea...

Страница 71: ...base before being saved and there is no way to recover them These messages advise that one consumable must be replaced Replace the consumable and CONFIRM to reset the counter See Chapter 8 MAINTENANCE If you don t replace the consumable press NO In this case you may still use the sterilizer but the message will appear again after some cycles WARNING Operating the sterilizer with expired consumable...

Страница 72: ...e the dust filter was locatedand push on the resetbuttonof the thermostatswitch seepictures to the left A click sound indicates that the thermostatswitch has beenreset Place the sterilizerback into its original position Insert the dust filter back into its original position Connect the mains cable and switch the sterilizerON Wait for the sterilizerto finish the errorreset phaseand followthe instru...

Страница 73: ...filter handle 5 As soonas the dooropens unplug the batterysupplyto prevent systemoverstrokeand consequentdamage Warning The following procedureshould be used only if necessaryand only when NO RESIDUALPRESSUREIS IN THE CHAMBER and the sterilizerhas completelycooleddown The sterilizershould be unplugged from the mains powersupply since 3 hours at least Any attemptto openthe doorwhile the unit is sti...

Страница 74: ...ndations as listed in ANNEX 2 Corrosion or spots on instruments Tap water on instruments when placedin the sterilizer Ensure that instruments are dry beforethey are placedin the sterilizer Use of water of poorquality or water containing chemicalsubstances Drain both water tanks Use water of good quality see ANNEX 7 Organic or chemicalresidues on the instruments Clean rinse and dry instruments befo...

Страница 75: ...cycle had finishedand the Sleepmode delay has expired Press the SLEEP MODE button to exit At the end of the cycle the displayreads Open the door but openingthe door is impossible The chamber is in vacuum due to an internal malfunction Switch the sterilizerOFF this releases any internal pressures allowing the chamber door to be opened Call technical service if the problempersists The bacteriologica...

Страница 76: ...componentsaccording to the materials they are made of drop the sterilizerwith a companythat specializeson the recycling of relatedproducts do not abandonthe sterilizerin unsecured places always refer to current applicablelaws and rules in the country of use The same instructions applyto disposalof all used consumableparts 10 Recycling and disposal ...

Страница 77: ... to 31 C linearlydecreasingto 50 at 40 C 20 C to 60 C 0 90 with empty tanks 3000masl 0 6 barA W 465 mm H 449 mm D 599mm W 485 mm H 499 mm D 619mm W 410 mm H 400 mm D 360mm 50 2kg LISA17 51 7kg LISA22 65 3kg LISA17 66 8kg LISA22 38 7 kN m2 LISA 17 39 8kN m2 LISA22 3000 KJoule hour Sterilizer chamber Pressuresafetyvalve Safetythermostats 2 6 bar 180 C Steam generator Pressuresafetyvalve Safetythermo...

Страница 78: ...nal cleaning This procedureinvolves the removalof residues blood dentine etc that adhereto critical areas such as sprayoutlets light ports knurling etc Wearprotectivegloves during cleaning Referto the instructions of the instrument manufacturer Use a soft damp brush and take care not to scratch the surface of the light ports Lubrication Once the instrument has beendisinfected cleanedand dried free...

Страница 79: ... the vertical position if possible to enhance drying Place emptyvesselsor non perforatedtrays upsidedown to prevent accumulation of water Items made from differentmaterials stainlesssteel carbonsteel aluminum etc must be placedon separatetrays or wrapped pouched If the instruments are manufactured from carbon steel papershould be placedbetweenthem and the trays to avoid rusty spots Sterilizehinged...

Страница 80: ...ersidefacing up Paper side up Space between bags Never placethe load or the trays directly into the chamberwithout the chamberrack as this could affect the steamand temperaturedistribution The load must always be supportedby the chamberrack Beforetouching ensure the sterilizationchamberis cold risk ofburns Partial loads If the chamber is just partially loaded place the loadin such a way that the s...

Страница 81: ...ELIX B D TEST see Running a sterilizationcycle Once the cycle is finished removethe test packfrom the chamber Removethe indicator sheetfrom the centerof the testpack and check the change in colour TEST PASSED The entire surface of the indicator sheethas changed colour TEST FAILED Certain areasof the indicatorsheet have not changed colour e g the central part has not turned dark due to an air pocke...

Страница 82: ...ing to the instructions of the test manufacturer Closethe capsule Once the cycle is finished removethe test device from the chamber Removethe indicator strip from the capsule and check the change in colour TEST PASSED The indicator strip has turned dark The air was completelyremovedfrom the capsule TEST FAILED Part of the chemical indicator strip has not turned dark showing that the air removalfro...

Страница 83: ...he test must be performedwhen the sterilizer chamber is completely dry and cold as otherwisethe test could producea false negative outcome Once the cycle is finished you may openthe chamberdoor A displaymessageinforms if the testpassedorfailed If the test failed check clean or replacethe doorgasket clean the chamberface sideand the chamberfilter repeatthe test If the test fails repeatedlycall tech...

Страница 84: ...de SiO2 1 mg l Iron 0 2 mg l Cadmium 0 005 mg l Lead 0 05 mg l Heavy metals excl iron cadmium lead 0 1 mg l Chloride 2 mg l Phosphate 0 5 mg l Conductivity at 20 C 15 µs cm pH value 5 7 Appearance colorless clean free from sediment Hardness 0 02 mmol l Chemical additives No chemicals or additives must be added to the water used for the steam sterilization process even if they are specifically clai...

Страница 85: ... pulses Phase of pressure rise to sterilization conditions Holdingtime process start Min and max temperature Min and max pressure Holdingtime process end Drying phase start Drying phase end Chamber venting phase Pressure levelingphase Cycle end conditions Cycle water consuption F0 Value Cycle time Cycle end date and time Cycle outcome Tracking code for traceability management Use only the printer ...

Страница 86: ...e Date and time of cycle start Dependingon the traceabilitysettings seeTRACEABILITY this field may contain the user who releasedthe cycle or the user who startedthe cycle or the sterilizerID Serialnumber Softwarerelease Expiry dateof the bag package If a STORAGE TIME was not set seeLABEL PRINTING OPTIONS this field shows the cycle outcome Traceabilitycode barcode Traceabilitycode alphanumerical Cy...

Страница 87: ... n 19721100LabelPrinter Only part n 19721123LisaSafeConnectionKit Includes USBconnectioncable 1 roll of 2100labels 1 Wax resinribbon activationcodeinstructions USB pen drive part n V000005x Drain tube kit with fittings part n A812110x ANNEX 10 Accessories and spare parts Ethernet cable 3 m part n A801500x Dist water distiller part n 19723101 Multidem C27 water demineralizer part n 19723112 Osmo wa...

Страница 88: ...tted with a backflowpreventing device complyingto IEC 61770 and to national and localregulations Maximum pressure 8 6 bar minimumflow 2 5 litres min maximum temperature 35 C Connection schemes APP ETHERNET LisaSafe USB drive S Print Osmo MULTIDEM External water filtration system Mdist Wi Fi Key ...

Страница 89: ...ers LISA 17 part n F523008x LISA 22 part n F523009x Standardchamber rack for 3 USA size cassettes LISA 17 part n F523020x LISA 22 part n F523021x Standardchamber rack for 4 cassettes LISA 17 part n F523012x LISA 22 part n F523015x Standardchamber rack for 2 implant cassettes LISA 17 part n F523016x LISA 22 part n F523017x All racks shown in this page if rotated 90 accept 5 standard aluminium trays...

Страница 90: ...nsumablessuitableto run 800 cycles It includes 1 doorseal 2 bacteriologicalfilters 2 dust filters 2 x 2 x Dust filter part n F364502x Replaceevery 400 cycles Door seal part n F460504x Replaceevery 800 cycles Bacteriological filter part n W322400x Replaceevery 400 cycles Consumables ...

Страница 91: ...icator YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO Use this page to createa logbooktracing the effectivenessof the sterilizationcycle during the whole lifespanofyour sterilizer ANNEX 11 Helix test documentation form ...

Страница 92: ...YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO YES NO ...

Страница 93: ...D 6 StroudWood Business Centre Park Street St Albans Herts AL2 2NJ t 44 1727 874990 f 44 1727 874628 technical uk wh com A DEC AUSTRALIA CO INC Unit 8 5 9 Ricketty Street Mascot NSW 2020 t 61 2 83324000 f 61 2 83324099 a dec a dec com au Ivoclar Vivadent NZ P O Box5243 WellesleyStreet 12 Omega Street Auckland t 64 9 914 9999 f 64 9 914 9958 ivoclarvivadent ivoclarvivadent co nz ...

Страница 94: ...VA131 ENG Rev 4 Subject to alterations 29 11 2017 Manufacturer W H Sterilization S r l Italy I 24060 Brusaporto Bg via Bolgara 2 t 39 035 66 63 000 f 39 035 50 96 988 wh com ...

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