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LISA | Instructions for Use | VA131 2019 ENG Rev06 | 16/04/2020 | © 2020 W&H Sterilization Srl

Introduction

For any suggestions or remarks please send an email to
[email protected].

COPYRIGHT NOTICE

Copyright © 2020, W&H Sterilization Srl

All rights reserved in all countries.

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

The information contained in this document is subject to change
without prior notice.

Use restrictions

INTENDED USE

LISA sterilizers are fully automated bench top steam sterilizers that
generate steam using electrical heaters.

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

The types of loads that can be sterilized with LISA sterilizers are
described in Table 1 of the reference technical norm EN 13060.

These loads include solid, porous, hollow loads type A and hollow
loads type B, unwrapped, single wrapped and double wrapped.

LISA sterilizers cannot be used to sterilize liquids or pharmaceutical
products.

PROVIDED FEATURES

See "Sterilization cycles" on page 116 for the full list of key program
features, including sterilization time, temperature and
recommended load type.

USER QUALIFICATION

The users who may operate the sterilizer are the following.

User
qualification

Competences

Head of the
clinic/practice

Legally responsible for:

n

the efficiency of the hygiene protocol in place

n

the sterilization process

n

the operators' training and training documentation

n

the correct operation and maintenance of the equipment

Trained
operators

n

Regularly attend the training for operating and using the
sterilizer safely.

n

Use the sterilizer according to the Head of the
clinic/practice's instructions.

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Содержание Lisa VA131-17

Страница 1: ...VA131 17 VA131 22 Instructions for Use VA131 2019 ENG Rev06 ...

Страница 2: ......

Страница 3: ...4 Standby mode 35 Administrator 37 User management 37 Traceability options 40 Hide Unhide a cycle 40 Managing printers 42 Printer selection optional 42 Label printer selection optional 42 Label printer usage optional 44 Label content description 47 Sterilizer tests 48 Sterilizer performance tests 48 Bowie and Dick test 48 Helix test 52 Vacuum test 54 Sterilization cycles 57 Load maintenance and pr...

Страница 4: ... 98 Disposal 99 Diagnostics 100 Errors 100 Troubleshooting 105 Emergency door opening 113 Technical data 116 Sterilization cycles 116 Sterilization cycle phases 120 Technical data 123 Recommendations for validation 124 Diagrams 125 Water quality 126 Accessories spare parts consumables 127 Authorized W H service partners 132 Documentation forms 133 W H installation check list 133 Helix test documen...

Страница 5: ...described in the module D1 AnnexIII 2012 19 EU Waste Electrical and ElectronicEquipment WEEE EN 13060 Small steam sterilizers IEC 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use general requirements IEC 61010 2 040 Safety requirements for electrical equipment for measurement control and laboratory use particular requirements for sterilizers and washe...

Страница 6: ...e conditions e g non sterile instruments which could lead to fatal personal injury CAUTION Indicates a hazardous situation that if not avoided could result in minor or moderate injury SYMBOLS DISPLAYED ON THE PRODUCT Hot surfaces Risk of burns Hot steam Risk of burns Consult the Instructions for Use for important cautionary information Consult the Instructions for Use Do not dispose of with normal...

Страница 7: ... integral part of the product and accompanies it for its entire working life It must be consulted in all situations related to the life cycle of the product from its delivery through to decommissioning For this reason it should always be accessible to operators both online and offline Contact customer service in the event the manual is unavailable If the device is transferred always attach the man...

Страница 8: ...body fluids e g instruments used by beauty therapists tattooists body piercers and hairdressers The types of loads that can be sterilized with LISA sterilizers are described in Table 1 of the reference technical norm EN 13060 These loads include solid porous hollow loads type A and hollow loads type B unwrapped single wrapped and double wrapped LISA sterilizers cannot be used to sterilize liquids ...

Страница 9: ...quids over the sterilizer risk of electrical short circuits n Switch off the sterilizer and unplug the mains cable before inspecting carrying out maintenance or servicing the sterilizer n Ensure that the power receptacle the sterilizer is connected to is properly grounded n All electric devices connected to the sterilizer shall be of Insulation Class II double insulated or higher n Use only the po...

Страница 10: ... responsible for the proper installation the correct use and maintenance of the sterilizer in accordance with these Instructions for Use n The safety devices of the sterilizer are impaired when the product itself is not installed used and serviced in accordance with these Instructions for Use n The Instructions for Use updated to the latest version is always available at www wh com n Keep these In...

Страница 11: ...ription 14 Installing the sterilizer 19 Operating the sterilizer 21 User interface menu 23 Sterilizer setup 30 User authentication 33 Set the Elisense system 33 USB pen drive 34 Standby mode 35 Unpacking UNPACK THE STERILIZER CAUTION Heavy product The sterilizer must be removed from the box and transported by two authorized technicians Weight n LISA 17 46 kg 101 4 lbs n LISA 22 47 5 kg 104 7 lbs ...

Страница 12: ... any damage immediately contact the dealer or shipping agent that has carried out the transport Keep the packaging for shipping or transporting the sterilizer in the future Note The packaging of the product is environmentally friendly and can be disposed of by industrial recycling companies CONTENTS OF THE PACKAGING Sterilizer Trays five Reversible rack Tray holder Mains cable Drain tube ...

Страница 13: ... capture waste water during manual tank draining volume larger than 5 l 1 3 gal n LAN cable for connecting the sterilizer to a network optional See Accessories spare parts consumables on page 127 for a full list of optional accessories Handling HOW TO RELOCATE THE STERILIZER Before transport n Completely drain both water tanks see Draining the used and clean water tank on page 98 n Allow the steri...

Страница 14: ...W H Sterilization Srl Product description FRONT VIEW 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 gasket M Door pin ...

Страница 15: ...ions for Use VA131 2019 ENG Rev06 16 04 2020 2020 W H Sterilization Srl 15 UPPER INTERNAL STRUCTURE Part Description A Tank B Water level sensor C Water tank cover D Internal tank cover E Tank internal filters with metal cartridges ...

Страница 16: ...NG Rev06 16 04 2020 2020 W H Sterilization Srl COMPONENTS BEHIND THE SERVICE DOOR Part Description A Bacteriological filter B Mains switch C Identification label D Used water drain port grey E Clean water drain port blue F Drain tube release button G USBport ...

Страница 17: ...Rev06 16 04 2020 2020 W H Sterilization Srl 17 REAR VIEW Part Description A USBand LAN ports B Air gap cover C Test connection D Pressure safety valve cover E Used water drain F Water supply inlet G Condenser grid H Mains cable guide I Mains cable plug socket ...

Страница 18: ...0 2020 W H Sterilization Srl CHAMBER ACCESSORIES 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 ...

Страница 19: ...eam can damage them The sterilizer must operate in absence of explosive atmospheres The sterilizer must operate in a well ventilated room far from sources of heat and from flammable materials Place the sterilizer on a flat and level surface Clearance requirements to ensure proper air circulation ELECTRICAL CONNECTIONS All the cables and tubes connected on the rear side of the sterilizer must be pl...

Страница 20: ...cturer s warranty is void if the sterilizer was used with water containing either chemical additives or contaminant levels exceeding those listed in these instructions See Feed water specifications EN 13060 on page 126 Notice The maintenance of the external water filling system must be done in exact accordance with the Instructions for Use given with the relevant system LAN CONNECTION 1 Insert a s...

Страница 21: ...e sterilizer on a sturdy flat and level surface 2 Remove all items from the sterilizer chamber except the chamber rack Remove all plastic covers from trays 3 Connect the auto fill and auto drain tubes in the rear of the sterilizer 4 Connect the Ethernet cable or the Wi Fi key in the rear of the sterilizer 5 Attach the power cord to the socket in the rear of the sterilizer and route the cord throug...

Страница 22: ...rilizer automatically turns in standby mode See Standby mode on page 35 3 Tap The homepage appears with the enabled sterilization cycles HOMEPAGE DESCRIPTION Part Description A Title purpose of the screen or the cycle number and the current date and time B Available cycles C Available tests D Additional buttons used to navigate the menu ...

Страница 23: ...Getting started LISA Instructions for Use VA131 2019 ENG Rev06 16 04 2020 2020 W H Sterilization Srl 23 User interface menu STRUCTURE AND NAVIGATION optional with Activation code optional ...

Страница 24: ... out the maintenance procedure Elisense Statistics Accesses the sterilizer statistic 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 Smart Intelligence Only if activated in the Elisense menu Enables each suggestions pop up and messages EliSense Sets the option of the touch screen LEDs Device ...

Страница 25: ... the status of the connection with the W H monitoring server Akidata status WI FI Selects a Wi Fi network when a Wi Fi key is connected Icon Label Function Ethernet Manages the Ethernet network Network Status Only with a network connection set Provides information about the network status Remote data storage Opens the remote folder Settings Sets the parameters of the network location Save all Copi...

Страница 26: ...an activation code n Sets the maximum storage time of the wrapped sterilized items n Sets the automaticor manual printing of the labels ACCESSORIES MENU FUNCTIONS Icon Label Function USBPen Drive Opens the formatting page of the USBpen drive Format Formats the USBpen drive Label Printer Optional activated with an activation code Selects the label printer and sets the printout layout Local Printer ...

Страница 27: ...teriological filter for replacement and resets its counter to zero Dust Filter Shows the status of the dust filter for replacement and resets its counter to zero Door Gasket Shows the status of the door gasket for replacement and resets its counter to zero Software Update Updates the software 4000 cycle service Shows the number of cycles performed and left before the necessary maintenance ...

Страница 28: ... the action function n Moves to the previous screen without confirming making any changes nor saving any parameters n Answers NOto a question Indicates that the ECODRYmode with extended drying is operating automatically Indicates that the ECODRYplus mode is operating automatically Increases decreases the value Indicates that an error occurs Icon Function Indicates that the option checked is workin...

Страница 29: ...trator credentials Gives information about the function displayed Confirms the active option and saves a setting or a parameter Copy the system info to the USBpen drive Shows an animation about the replacement procedure Shows a sterilization summary LISA Instructions for Use VA131 2019 ENG Rev06 16 04 2020 2020 W H Sterilization Srl 29 Getting started ...

Страница 30: ... prefer 3 Tap to confirm a confirmation message requiring the restarting of the sterilizer appears 4 Turn the sterilizer OFF and then ON SET THE DATE AND TIME To change the current date and time 1 On the homepage tap 2 Tap the value you want to change time date format the highlighted value can be changed 3 Tap or to change the value 4 Tap to confirm and go back to the previous page ...

Страница 31: ...rm 5 Tap to go back to the previous page SET THE DISPLAY BRIGHTNESS To change the display brightness 1 On the homepage tap 2 Tap or to change the value 3 Tap to confirm and go back to the previous page CONNECT TO A NETWORK If you connect through an Ethernet cable in most cases the sterilizer will connect to the network automatically If it does not connect automatically or if you are using a Wi Fi ...

Страница 32: ...ans cable or Wi Fi key are not properly plugged Note in the TPC IP screen the icon is visible only if you make any change The Wi Fi icon at the bottom will not be visible if you connect through Ethernet cable 4 If your network supports dynamic IP addresses ask your IT manager enable the options Dynamic both in IP Configuration and in the DNS Configuration fields then tap to confirm all entry field...

Страница 33: ... your account 1 On the homepage tap 2 Tap your user name 3 Enter your current PIN and tap to confirm 4 Tap 5 Enter your new PIN and tap to confirm a confirmation message with your new PIN appears 6 Tap and then to go back to the previous page WHAT TO DO IF YOU FORGET YOUR PIN If Then you are a common user contact the administrator you are the administrator contact your authorized service provider ...

Страница 34: ...ite blinking Active message pop up that disappears when touching the display Note The LEDs are active only when the sterilizer door is open SET THE OPTIONS OF THE TOUCH SCREEN LEDS To set the information that the LEDs will shown do the following 1 On the homepage tap 2 To activate an option tap 3 To deactivate an option tap 4 Tap to confirm and go back to the previous page USB pen drive DESCRIPTIO...

Страница 35: ...ata will be erased Notice Formatting erases all data from the pen drive Be sure you have already saved your data on a safe support before formatting Standby mode DESCRIPTION When in standby mode the sterilizer display remains dark and the sterilizer chamber is not heated to save energy If the sterilizer is not used for a certain period of time it automatically switches to standby mode ENTER THE ST...

Страница 36: ...6 16 04 2020 2020 W H Sterilization Srl Getting started EXIT THE STANDBY MODE Tap or open or close the chamber door CHANGING STANDBY MODE DELAY TIME 1 On the homepage tap 2 Tap or to change the delay 3 Tap to confirm and go back to the previous page ...

Страница 37: ...bjects User management 37 Traceability options 40 Hide Unhide a cycle 40 User management FUNCTION AVAILABILITY WHO CAN MANAGE USERS AND RESET THEIR PIN Only a user with administrator rights can create and delete users and reset the PIN code of a user to 0000 ADD A USER 1 On the homepage tap 2 Tap your user name 3 Enter the PIN and tap to confirm 4 Tap ...

Страница 38: ...ser name and tap to confirm 7 If desired tap to give the administrator authority to the new user 8 Tap to confirm the PIN of the new user is set to 0000 and a confirmation message appears 9 Tap and then to go back to the previous page 10 Tap to return to the homepage DELETE A USER 1 On the homepage tap 2 Tap your user name 3 Enter the PIN and tap to confirm ...

Страница 39: ... Tap to confirm RESET A USER PIN 1 On the homepage tap 2 Tap your user name 3 Enter the PIN and tap to confirm 4 Tap and the user name for which you want to reset the PIN 5 Tap to confirm the PIN is set to 0000 and a confirmation message appears 6 Tap to return to the homepage Note Remember the user to change their PIN before reusing the sterilizer ...

Страница 40: ... OPTIONS 1 On the homepage tap 2 Tap your user name 3 Enter your PIN and tap to confirm 4 Tap the information to be requested to the users at the beginning and at the end of the cycle 5 If you want the user to check the load and release it as valid at the end of the cycle tap 6 Tap to confirm and go back to the previous page Hide Unhide a cycle WHO CAN HIDE UNHIDE A CYCLE Only a user with administ...

Страница 41: ...H Sterilization Srl 41 Administrator HIDE UNHIDE A CYCLE 1 On the homepage tap 2 Tap your user name 3 Enter your PIN and tap to confirm 4 Tap to hide a cycle from the homepage 5 Tap to unhide a cycle from the homepage 6 Tap to confirm and go back to the previous page ...

Страница 42: ... printer models available through manufacturer importer 1 On the homepage tap 2 Tap the model of the printer to use 3 Tap to confirm and go back to the previous page Label printer selection optional FUNCTION AVAILABILITY The first time you access the Label Printer menu you will be requested to enter an activaction code To require the activation code please refer to the Activation code instructions...

Страница 43: ... the label area 4 Tap to print a test label 5 If the printout is not duly centered tap or to center it horizontally x and vertically y 6 If necessary tap to print another test label and repeat step 4 7 Tap to confirm the settings and go back to the previous page SELECT A SHARED LABEL PRINTER 1 Ensure the sterilizer to which the printer is physically connected is ON and no cycle is running 2 From t...

Страница 44: ...ted confirm the printer sharing 10 Tap again to print a test label Label printer usage optional CAUTION For your safety and the safety of your patients use a storage time compliant with the recommendations of the manufacturers of the containters packaging used and with applicable norms and rules FUNCTION AVAILABILITY The first time you access the Label Printer menu you will be requested to enter a...

Страница 45: ...tic label printing a maximum storage time in weeks can be set This value is used to calculate the expiry date to be printed on the labels see Label content description on page 47 SET THE AUTOMATIC LABEL PRINTING 1 On the homepage tap 2 Activate Automatic printing 3 Tap or to set the maximum storage time and the number of labels to be printed automatically 4 Tap to confirm and go back to the previo...

Страница 46: ...20 2020 W H Sterilization Srl Managing printers DISABLE THE LABEL PRINTING If the label printing is disabled no label can be printed at the end of a sterilization cycle 1 On the homepage tap 2 Activate Disabled 3 Tap to confirm and go back to the previous page ...

Страница 47: ...release B Traceability code alphanumerical and bar code Released Depending on the traceability settings this field may contain one of the following elements n the user who released the cycle n the user who started the cycle n the sterilizer ID Cycle Cycle name Number Cycle number Date Date and time of cycle start Expiry date n Expiry date of the bag package n The cycle outcome if a storage time is...

Страница 48: ...FORMED ON THE STERILIZER Test Purpose Reference Bowie and Dick test Validate the sterilizer performance for textile load sterilization See Bowie and Dick test below Helixtest Validate the sterilizer performance for hollow items See Helixtest on page 52 Vacuum test Validate the sterilizer performance in terms of n efficiency of the vacuum pump n tightness of the pneumaticcircuit See Vacuum test on ...

Страница 49: ... small packet with a chemical heat sensitive indicator sheet in the middle The colour assumed 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 Remove all trays from the sterilization chamber except the lowest one 2 Place the Bowie and Dick test pack in...

Страница 50: ...door locks 6 Wait until the end of the test and tap OPEN the chamber door unlocks 7 Enter your credentials if required 7 Open the chamber door extract the tray using the tray holder and take the test pack The test pack can be wet outside CAUTION Risk of burns The test pack is very hot at the end of the cycle Wear appropriate PPE e g gloves 8 Remove the indicator sheet from the center of the test p...

Страница 51: ...RESULT Indicator What happened Test passed 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 air pocket during the cycle due to sterilizer malfunction No Repeat the test If it fails repeatedly call technical service ...

Страница 52: ...open on one side and closed with a capsule containing a chemical indicator strip on the other side The colour assumed 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 Remove all trays from the sterilization chamber except the lowest one 2 Unscrew the t...

Страница 53: ...f a tray in the lowest rack position and close the chamber door 5 On the homepage tap Helix B D test 6 To set the duration of the Plateau Sterilization phase and other settings tap 7 Tap and enter your credentials if required the chamber door locks 8 Wait until the end of the test and tap OPEN the chamber door unlocks 9 Enter your credentials if required ...

Страница 54: ...as turned dark The air was completely removed from the capsule Yes Part of the chemical indicator strip has not turned dark The air removal from the capsule was not complete No Repeat the test If it fails repeatedly call technical service WHAT TO DO NEXT Compile the Helix test documentation form to trace the effectiveness of the sterilization cycle during the whole lifespan of your sterilizer See ...

Страница 55: ...itored 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 and cold to avoid any false negative outcome 3 On the homepage tap Vacuum test 4 Tap and enter your credentials if required the chamber door locks 5 Wait un...

Страница 56: ...0 2020 W H Sterilization Srl WHAT TO DO WHEN 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 ...

Страница 57: ... lubricated in accordance with the instrument manufacturer s instructions Notice Any residual of chemicals could seriously damage the sterilizer The manufacturer s warranty is void in case of damage caused by chemicals DENTAL HANDPIECES EXTERNAL DISINFECTION This procedure reduces the risk of infection during cleaning and maintenance of the dental handpieces n Wear protective gloves during disinfe...

Страница 58: ...ts and detergents Rinse and dry carefully all instruments The instruments and tubes must be carefully rinsed and dried prior to sterilization CORRECT LOAD PLACEMENT WARNING Do not overload trays and the chamber Adhere to the maximum load weight limits see Sterilization cycles on page 116 Never place the load or the trays directly into the chamber without the chamber rack as this could affect the s...

Страница 59: ...om different materials stainless steel carbon steel aluminum etc On separate trays or wrapped pouched Instruments manufactured from carbon steel Place paper among them and the trays to avoid rusty spots PARTIAL LOAD If the chamber is just partially loaded place the load in such a way that the space in between the trays is maximized Spread items evenly on multiple trays Below is a example with thre...

Страница 60: ...ions 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 when only one tray is used always place the load on the upper tray of the chamber rack and remove all other trays from the chamber Sterilization cycle description AVAILABLE STERILIZATION CYCLES See Steriliza...

Страница 61: ...s 3 Check the icon in the top left corner of the page to know the ECO DRY mode assigned to the cycle 4 Tap n to change the ECO DRY mode see Change the ECO DRY mode on page 66 n to disable the ECO DRY mode see Set the drying time on page 65 5 If the door gasket is new hold the door gently closed until step 7 6 Tap and enter your credentials if required the door locks If you have not set a different...

Страница 62: ...cle parameters on page 66 9 Tap OPEN the door unlocks 10 If required enter your credentials and confirm the release of the load if needed SET THE STERILIZATION CYCLE START You may schedule the start of the sterilization cycles at a certain date and time e g if you want to load the sterilizer in the evening and run standard sterilization cycle early the next morning before office hours You can set ...

Страница 63: ...ious page 5 To change the start time tap Start cycle at 6 Tap the time or the date a settings page opens 7 Tap the number you want to change and tap or to increase it or decrease it 8 Tap to confirm and go back to the previous page 9 Tap to lock the door and start the countdown for the current cycle Note You can decide to start the cycle immediately or stop the countdown at any time ...

Страница 64: ...t a preset date and time e g if you want to run a vacuum test plus a HELIX test in the early morning before office hours Maximum two cycles can be programmed To program the sterilizer proceed as follows 1 Load the chamber and close the chamber door 2 On the homepage tap 3 Tap to add a cycle to the list above 4 Tap and then the cycle you want to add 5 Tap the cycle is automatically listed in the pr...

Страница 65: ...A CYCLE FROM A PROGRAMMED SEQUENCE 1 On the homepage tap 2 Tap the cycle you want to remove from the sequence 3 Tap to remove the selected cycle 4 Tap to confirm and go back to the previous page SET THE DRYING TIME For each ECO DRY mode the drying time is automatically adjusted to the total amount of load and cannot be modified To set a new drying time for the program you should disabled the ECO D...

Страница 66: ...omes the new fixed value CHANGE THE ECO DRY MODE 1 On the homepage tap the cycle and 2 Tap the leaf icon to set the ECO DRY mode 3 Tap the ECO DRY mode you desire 4 Tap to confirm and go back to the previous page 5 Tap to go back to the homepage VIEW THE CYCLE PARAMETERS You can check the real time cycle parameters or the cycle parameters at the end of the cycle Following is an example 1 While the...

Страница 67: ...formation page END OF A STERILIZATION CYCLE When a cycle is successfully finished the Cycle completed message appears on the screen To end the cycle 1 Tap to view the cycle summary or tap to view the cycle parameters See View the cycle parameters on the previous page 2 Tap OPEN to open the door the door unlocks and the home page appears Note if an error message appears see Troubleshooting on page ...

Страница 68: ...ile if this occurs before the DRY phase A cycle can be manually aborted at any time To stop a cycle 1 Tap STOP a confirmation request appears 2 Tap to abort the stop command The cycle continues programmed 3 Tap to abort the cycle the sterilizer starts a reset phase Notice Do not switch off the sterilizer during the reset phase it takes some time to reset the system and reach safe conditions in the...

Страница 69: ...Following 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 burns Before touching ensure the sterilization chamber is cold Always use the tray holder Sterilization cycle report WHERE CYCLE DATA ARE STORED The sterilizer stores in memory the summarized reports of the las...

Страница 70: ...e connected to the sterilizer as soon as a new cycle starts VIEW CYCLE HISTORY To view the sterilization cycle history 1 On the homepage tap all the sterilization cycles are listed with number date time and sterilization program The sterilization cycle interrupted because of a cycle error or problem appears in red 2 Scroll the list and tap the desired sterilization cycle the report opens PRINT OR ...

Страница 71: ... Sterilization cycles 4 Tap to print the report or tap to save the report on the USB pen drive PRINT LABELS FOR A SPECIFIC CYCLE 1 On the homepage tap 2 Scroll the list and tap the desired sterilization cycle the report opens 3 Tap 4 Tap to print traceability labels for the selected cycle ...

Страница 72: ...he confirmation all sterilization cycle reports are stored in the USB SET THE REMOTE FOLDER FOR SAVING THE REPORTS To activate the remote storage and set the necessary parameters do the following 1 On the homepage tap 2 Tap to enable the remote data storage the first four fields in the page and the check box turn dark grey 3 In Path enter the name of the shared folder followed by the sub folder na...

Страница 73: ... previous page 9 To check if the parameters entered are valid see Test the data storage below TEST THE DATA STORAGE Note The test function is available only if the remote data storage is enabled See Set the remote folder for saving the reports on the previous page 1 On the homepage tap 2 Tap a sequence of tests is automatically performed 3 In case a test fails check the relevant settings and tap t...

Страница 74: ...RTS IN A REMOTE FOLDER Note The save all function is available only if the remote data storage is enabled See Set the remote folder for saving the reports on page 72 Only the last 400 cycles in HTML and 50 cycles in SCL in the sterilizer memory can be saved in the remote folder 1 On the homepage tap 2 Tap to start the remote saving ...

Страница 75: ...ycle 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 start n MIN MAX temperature n MIN MAX pressure PRE Plate...

Страница 76: ...2020 W H Sterilization Srl Sterilization cycles 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 ...

Страница 77: ...vel of 215 lx 15 lx to 1500 lx 15 lx Before making any operation ward off unauthorized personnel from the working area CAUTION Before accessing the chamber and the connected parts be sure that the sterilizer is cold Notice Follow the instructions in this chapter when carrying out any maintenance on the sterilizer Ordinary maintenance MAINTENANCE BY THE USER Frequency 1 Cycles 1 Operation Monthly 5...

Страница 78: ...ged or if the filters are clogged or discolored EXPIRED MAINTENANCE A video animation is available on https video wh com en_ global dental faq The sterilizer monitors the wear of consumables by counting the number of cycles executed since the last replacement When the number of cycles is close to the maximum a pre alert about the concerned consumable is displayed Please check that you have the req...

Страница 79: ...les before the request of replacement appears you should manually reset the counters through the following procedure 1 On the homepage tap 2 Select the consumable you want to replace a message appears showing the current worked hours of the part 3 Tap to see an animated replacement procedure 4 When you have replaced the consumable tap to confirm the executed cycle counter is reset ...

Страница 80: ... Clean the seal seat and the chamber face side with a damp lint free cloth moistened 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 plastic body 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 the sterilization ...

Страница 81: ... the chamber with a damp sponge and a mild detergent solution paying attention not to bend or damage the temperature probe inside the sterilizer chamber 3 Rinse with water 4 Clean the trays and the chamber rack with a damp sponge and a mild detergent solution 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 w...

Страница 82: ...020 2020 W H Sterilization Srl CLEANING THE CHAMBER FILTER Proceed 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 ...

Страница 83: ...6 16 04 2020 2020 W H Sterilization Srl 83 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 ...

Страница 84: ... Sterilization Srl 8 Lock the filter cap by turning it clockwise CLEANING THE EXTERNAL SURFACES OF THE STERILIZER Proceed as follows 1 Clean all external sterilizer covers with a slightly damp cloth moistened with water Notice Never use disinfectants detergents or abrasive products ...

Страница 85: ... 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 consumable before the maintenance due date on page 79 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 ...

Страница 86: ...ideo 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 consumable before the maintenance due date on page 79 Proceed as follows 1 Pull out the dust filter handle from underneath the sterilizer ...

Страница 87: ...Maintenance LISA Instructions for Use VA131 2019 ENG Rev06 16 04 2020 2020 W H Sterilization Srl 87 2 Lift the used filter from the handle and remove it 3 Insert the new filter into the handle ...

Страница 88: ...e handle back into its original position 800 cycle or biannual maintenance SEQUENCE OF PROCEDURES TO CLEAN THE WATER TANKS To 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 90 3 Clean the water tanks on page 92 ...

Страница 89: ...on 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 98 3 To drain the detergent solution during the subsequent cleaning leave the drain tube attached to the drain port of the tank you want to clean ...

Страница 90: ...structions for Use VA131 2019 ENG Rev06 16 04 2020 2020 W H Sterilization Srl ACCESS TO THE WATER TANKS A video animation is available on https video wh com en_global dental faq Proceed as follows 1 Lift the water tank cover ...

Страница 91: ...2020 W H Sterilization Srl 91 2 Remove the internal tank cover 3 Clean and dry the internal tank cover and its rubber membrane to eliminate any condensate Notice Never use disinfectants strong detergents or abrasive products Use a slightly damp cloth moistened with water ...

Страница 92: ... the sterilizer could be impaired 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 a small 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 the i...

Страница 93: ...A Instructions for Use VA131 2019 ENG Rev06 16 04 2020 2020 W H Sterilization Srl 93 5 Remove the internal filters 6 Clean the metal cartridges of the internal filters with tap water 7 Reposition the internal filters ...

Страница 94: ...Maintenance 94 LISA Instructions for Use VA131 2019 ENG Rev06 16 04 2020 2020 W H Sterilization Srl 8 Reposition the internal tank cover and then the water tank cover 9 Detach the drain tube ...

Страница 95: ...al faq Notice If you replace this consumable before the maintenance due date you have to reset the cycle counter See Replace the consumable before the maintenance due date on page 79 Proceed as follows 1 Fully open the chamber door 2 Remove the used door gasket by hand 3 Carefully clean the seal seat and the chamber face side with a damp lint free cloth 4 Moisten the new seal with water to facilit...

Страница 96: ...n 6 Press left and right and then the entire seal circumference to ensure its perfect placement Notice A steam discharge can damage the sterilizer plastic parts Ensure the seal does not stick out 7 Wipe any residual water and run a Vacuum and Helix test to check for perfect tightness of the seal See Vacuum test on page 54 and Helix test on page 52 ...

Страница 97: ...er important internal components n a check of the entire sterilizer with special care for the safety systems n the cleaning of areas and components that cannot be accessed by the user ACTIONS REQUIRED FOR EACH ELEMENT For 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...

Страница 98: ...lizer for at least seven days you have to drain the tanks 1 Open the sterilizer service door 2 Put a container below the sterilizer 5 l 1 3 gal minimum and place the end of the 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 ...

Страница 99: ...ade 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 MATERIALS The sterilizer is mainly built from fiber reinforced polymers metals and electric electronic comp...

Страница 100: ...escription Actions 0xx Load cannot be considered sterile See End of a sterilization cycle on page 67 Repeat the cycle If the problem persists call service Check if the mains 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 sterili...

Страница 101: ...and the chamber furniture from residuals of detergents disinfectants and other chemicals Replace the clean water if it is suspected to be contaminated with chemicals Ensure all the load is clean rinsed and free from any chemicals before sterilizing Start a vacuum test to check the tightness of the pneumaticcircuit 18x Chamber filter clogged Remove and clean the chamber filter See error 13xto 16x a...

Страница 102: ...there are hurdles on the door locking area chamber rack loads objects Repeat the cycle If the problem persists call service Check the door gasket wrong placed Check if the door can move freely without touching the trays or the load when closing Switch the sterilizer OFF and ON 990 The cycle has been aborted by the user Re process the load MESSAGES AND ALERTS Notice For any error not listed in this...

Страница 103: ...e on page 77 Bact 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 4000 cycle maintenance must be performed in cycles Have you already booked the 4000 cycle service This pre alert advises you that the target of 4000 cycles is close and the relevant maintenance step is to be scheduled Contact your Technical Se...

Страница 104: ...e you may still use the sterilizer but the message will appear again after some cycles CAUTION Operating the sterilizer with expired consumables could be dangerous and could damage the sterilizer Bact Filter replacement is due Have you replaced the bacteriological filter Dust Filter replacement is due Have you replaced the dust filter 4000 cycle service Please call your technical support to organi...

Страница 105: ...terilizer during the reset phase it takes some minutes to reset the system and reach safe conditions in the sterilizer chamber 2 When the OPEN button appears tap it to unlock the door 3 Confirm the opening of the door Notice Water could be present in the chamber when opening the door prevent spilling e g place a towel below the chamber door VIEW AND SAVE THE ERROR LOG 1 On the homepage tap a list ...

Страница 106: ...ed 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 100 C Warning messages D Open button that appears after the reset phase had finished WARNING MESSAGES Message Description Load not sterile The load is not sterile WARNING Do not use items on patients Drying interrupted The load might b...

Страница 107: ...rilizer is fitted with a safety thermostat to prevent it from overheating If the safety thermostat operates because of too high temperatures 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 ...

Страница 108: ...131 2019 ENG Rev06 16 04 2020 2020 W H Sterilization Srl 3 Remove the dust filter and move the sterilizer closer to the shelf edge 4 Push the reset button of the thermostat switch a click sound indicates that the thermostat switch has been reset ...

Страница 109: ...st 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 on the display Note If the thermostat operates repeatedly call technical service ...

Страница 110: ...the chamber door gasket Clean or replace the door gasket Clean the chamber face side Internal leak Call technical service The cycle commences but there is no pressure temperature rise The safety thermostat switch is open Reset the safety thermostat switch See Extraordinary maintenance on page 98 Electric electronicfault Call technical service At the end of the cycle there is residual water in the ...

Страница 111: ...em See Load maintenance and preparation on page 57 Scale deposits on the chamber Clean the chamber and use water of good quality See Water quality on page 126 Instruments are turning brown or black Incorrect temperature selected Select a sterilization cycle featuring a lower sterilization temperature Follow the instructions of the instrument manufacturer The cycle report printer does not work Prin...

Страница 112: ...o exit At the end of the cycle the display reads Open the door but opening the door is impossible The chamber is in vacuum due to an internal malfunction Switch the sterilizer OFF this releases any internal pressures allowing the chamber door to be opened Call technical service if the problem persists The bacteriological filter is blocked Remove the bacteriological filter to get the pressure relea...

Страница 113: ...ng procedure only when the sterilizer has completely cooled down The sterilizer should be unplugged from the mains power supply for at least 3 hours before executing this procedure Notice Carry out this procedure only as indicated and with the sterilizer in the indicated conditions Any attempt to open the door in a different way can seriously damage the sterilizer OPENING TOOL The door locking sys...

Страница 114: ...ctions for Use VA131 2019 ENG Rev06 16 04 2020 2020 W H Sterilization Srl 2 Extract the dust filter and remove the auxiliary cable loom 3 Firmly open the service door 4 Unscrew the bacteriological filter by hand counter clockwise ...

Страница 115: ...onnectors 6 Holding the service door pulled plug the plastic connector into the socket behind the bacteriological filter 7 As soon as the door opens unplug the plastic connector to prevent system overload and consequent damage 8 Put the auxiliary cable loom back in the dust filter handle and insert the dust filter in the sterilizer ...

Страница 116: ... the maximum load weight limits specified 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 manufacturer cannot be hold responsible All indications of sterile load or successful completion of the cycle...

Страница 117: ...stics 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 suitable for 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 they must be used immedi...

Страница 118: ...oad turbines and handpieces family TOTAL CYCLE DURATION The 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 weight n 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 LIS...

Страница 119: ...s 4 5 kg 10 lbs 6 0 kg 13 2 lbs 1 5 kg 3 3 lbs 2 0 kg 4 4 lbs BExtended 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 2 0 kg 4 4 lbs 2 0 kg 4 4 lbs MAXIMUM LOAD FOR CONTAINERS The correct dryness can only be obtained with the ECO DRY mo...

Страница 120: ...ating 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 DRY Vacuum drying SEP Short phase to clean the circuit from used water LEV Leveling Pressure inside the sterilization c...

Страница 121: ... 16 04 2020 2020 W H Sterilization Srl 121 TYPE B STERILIZATION CYCLE PHASES All type B sterilization cycles feature the same basic pressure profile as shown in the graph below The duration and the temperature sterilization phase differ between the various cycles ...

Страница 122: ...W H Sterilization Srl TYPE S STERILIZATION CYCLE PHASES The S Fast 134 cycle is specifically designed to sterilize unwrapped instruments for immediate use on patients not requiring a complete drying Thus the drying phase of this cycle is short making this cycle the fastest available ...

Страница 123: ... or less if required by local regulations Automatic circuit breaker min 10 A INSTALLATION REQUIREMENTS Working 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 empty tanks Max altitude 3000 m asl Min atmospheric pressure 0 6 bar 8...

Страница 124: ...ure safety valve 5 bar 72 51 psi Safety thermostats 230 C 446 F DISTILLED OR DEMINERALIZED WATER Water quality Fulfilling EN 13060 Ann C conductivity 15μS cm Total Dissolved Solids 10 ppm Average water consumption 0 32 to 0 65 litres cycle 0 08 to 0 17 gal cycle Tank volume Clean water 4 8 l 1 27 gal 2 8 l 0 74 gal with air gap Used water 4 8 l 1 27 gal Recommendations for validation TEST VALIDATI...

Страница 125: ...H Sterilization Srl 125 Diagrams CONNECTION DIAGRAMS Data communication Water system Note The water filtration system must be fitted with a backflow preventing device complying to IEC 61770 and to national and local regulations For water requirements see Technical data on page 123 ...

Страница 126: ...ity at 20 C 15 µs cm pH value 5 7 Contaminants minerals qualities Value Specification 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 claimed for use in steam generators or for steam production or as additives for sterilization disinfecti...

Страница 127: ...28 x312 n 188 x22 x312 F523031X Note rack rotated 90 Standard chamber rack for 3 cassettes containers for LISA 17 Usable space Cassette size mm n 190 x50 x312 n 190 x50 x312 n 190 x50 x312 Picture Part Part number Standard chamber rack for 5 aluminium trays for LISA 22 Usable space Cassette size mm n 188 x21 x400 n 188 x28 x400 n 188 x28 x400 n 188 x28 x400 n 188 x22 x400 F523032X Note rack rotate...

Страница 128: ...l chamber rack for 3 cassettes containers for LISA 22 Usable space Cassette size mm n 205 x35 x380 n 210 x35 x380 n 205 x35 x380 F523021X Picture Part Part number Optional chamber rack for 4 cassettes containers for LISA 17 Usable space Cassette size mm n 190 x32 x300 n 210 x32 x300 n 210 x32 x300 n 190 x32 x300 F523012X Optional chamber rack for 4 cassettes containers for LISA 22 Usable space Cas...

Страница 129: ...hamber rack for 2 cassettes containers for LISA 22 Usable space Cassette size mm n 190 x70 x380 n 190 x70 x380 F523017X Picture Part Part number Optional chamber rack for 6 aluminium trays for LISA 17 Usable space Cassette size mm n 188 x19 x312 n 188 x21 x312 n 188 x21 x312 n 188 x21 x312 n 188 x21 x312 F523033X Note rack rotated 90 Optional chamber rack for 3 cassettes containers for LISA 17 Usa...

Страница 130: ... Usable space Cassette size mm n 190 x50 x400 n 190 x50 x400 n 190 x50 x400 Picture Part Part number Optional chamber rack for 2 aluminium trays and 3 wider aluminium trays for LISA 22 Usable space Cassette size mm n 188 x22 x400 n 215 x21 x400 n 215 x28 x400 n 215 x28 x400 n 188 x22 x400 F523035X Note rack rotated 90 Optional chamber rack for 3 cassettes containers for LISA 22 Usable space Casset...

Страница 131: ...le U38011XX Ethernet cable 3 m A801500X USBpen drive V000005X Cycle report printer Model S Print 19721108 Picture Part Part number USB serial adapter for the connection of the cycle report printer A801503X Label printer LisaSafe label printer only 19721109 LisaSafe Connection Kit n USBconnection cable n 1 roll of 2100 labels n 1 wax resin ribbon n activation code instructions 19721123 QR code Bar ...

Страница 132: ...ays CONSUMABLES Picture Part Part number When replace it Bacteriological filter W322400X Every 400 cycles Door gasket F460504X Every 800 cycles Dust filter F364511X Every 400 cycles Picture Part Part number When replace it 400 800 cycle consumable kit Components n 1 door gasket n 2 bacteriological filters n 2 dust filters X050328X Refer to each single component above 250 helixstrips T800205X Befor...

Страница 133: ... 7 Were all sections of the Instructions for Use of the sterilizer covered 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 area for the sterilizer respected Yes No 10 Are the required minimum clearances respected Yes No 11 Have you explained whic...

Страница 134: ...he advantages of having a Wi Fi connection remote data saving Yes No 23 Have you explained to the head of the clinic practice the correct load type for each available sterilization program Yes No 24 Have you shown the head of the clinic practice how to prepare and place the load in the sterilizer chamber Yes No 25 Have you explained to the head of the clinic practice to use only original parts and...

Страница 135: ... H Sterilization Srl 135 Documentation forms ADDRESSES FOR SENDING THE INSTALLATION CHECK LIST Send a copy of the installation check list duly fill in to both of the following addresses Fax 43 6274 6236 55 Mail Ignaz Glaser Straße 53 Postfach 1 5111 Bürmoos Austria ...

Страница 136: ...zation Srl Helix test documentation form INSTRUCTIONS Use 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 Yes No Yes No Yes No Yes No Yes No ...

Страница 137: ...SA Instructions for Use VA131 2019 ENG Rev06 16 04 2020 2020 W H Sterilization Srl 137 Date Cycle n Operator Released Signature Chemical indicator Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No ...

Страница 138: ...on forms 138 LISA Instructions for Use VA131 2019 ENG Rev06 16 04 2020 2020 W H Sterilization Srl Date Cycle n Operator Released Signature Chemical indicator Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No ...

Страница 139: ......

Страница 140: ...Manufacturer W H Sterilization Srl via Bolgara 2 Brusaporto BG Italy www wh com 39 035 66 63 000 VA131 2019 Instructions for Use ENG Rev06 16 04 2020 Subject to changes ...

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