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LARA | Instructions for use | RIL-1 ENG Rev04 | 28/02/2019 | © 2019 W&H Sterilization Srl

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Conformity

CONFORMITY TO EUROPEAN STANDARDS AND DIRECTIVES

STERILIZER featuring sterilization cycles conform with the following
standards:

Standards
and
Directives

Description

93/42/EEC

Medical Device Directive (MDD).

Medical Device Directive 93/42/EEC for devices class IIb, in
accordance 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) for
every sterilization chamber designed and manufactured in
conformity to the ANNEX 1 and to the procedure described in the
module D1 Annex III.

2012/19/EU

Waste Electrical and Electronic Equipment (WEEE).

EN 13060

Small steam sterilizers.

IEC 61010-1

Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.

IEC 61010-
2-040

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

IEC 61326-1

Electrical equipment for measurement, control and laboratory use -
EMC requirements; general requirements.

IEC 61770

Electric appliances connected to the water mains - Avoidance of
backsiphonage and failure of hose-sets.

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

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

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Содержание Lara RIL-117

Страница 1: ...RIL 117 RIL 122 Instructions for use RIL 1 ENG Rev04 ...

Страница 2: ......

Страница 3: ...r management optional 35 Traceability options optional 38 Managing printers 39 Printer selection optional 39 Label printer selection optional 39 Label printer usage optional 41 Label content description 44 Sterilizer tests 45 Sterilizer performance tests 45 Bowie and Dick test 45 Helix test 49 Vacuum test 52 Sterilization cycles 54 Load maintenance and preparation 54 Prepare the sterilizer 56 Ster...

Страница 4: ... 96 Disposal 99 Diagnostic 100 Errors 100 Troubleshooting 106 Technical data 111 Sterilization cycles 111 Sterilization cycle phases 115 Technical data 118 Recommendations for validation 120 Diagrams 121 Water quality 122 Accessories spare parts consumables 123 Authorized W H service partners 128 Documentation forms 131 W H installation check list 131 Helix test documentation form 134 ...

Страница 5: ...scribed 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 washer ...

Страница 6: ...onditions 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 wa...

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

Страница 8: ...rilized with LARA sterilizers are described in Table 1 of the reference technical norm EN 13060 These loads include solid porous hollow loads type A and hollow loads type B unwrapped single wrapped and double wrapped LARA sterilizers cannot be used to sterilize liquids or pharmaceutical products The device is intended for professional use only by trained people PROVIDED FEATURES See Sterilization ...

Страница 9: ...ids 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 powe...

Страница 10: ...sponsible 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 Instr...

Страница 11: ...19 Operating with the sterilizer 21 User interface menu 23 Sterilizer setup 29 User authentication optional 31 USB pen drive 32 Standby mode 33 Unpacking UNPACK THE STERILIZER CAUTION Heavy product The sterilizer must be removed from the box and transported by two authorized technicians The sterilizer must be removed from the box and transported using the specific straps Weight n LARA 17 42 5 kg 9...

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

Страница 13: ...ing manual tank draining volume larger than 5 l 1 3 gal n LAN cable for connecting the sterilizer to a network optional See Accessories spare parts consumables on page 123 for a full list of optional accessories Handling HOW TO RELOCATE THE STERILIZER Before transport n Completely drain both water tanks see Draining the used and clean water tank on page 92 n Allow the sterilization chamber to cool...

Страница 14: ...2019 2019 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 Door seal L Door pin ...

Страница 15: ...ctions for use RIL 1 ENG Rev04 28 02 2019 2019 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: ... Rev04 28 02 2019 2019 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: ...04 28 02 2019 2019 W H Sterilization Srl 17 REAR VIEW Part Description A USBport optional 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: ...2019 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: ...m 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 plac...

Страница 20: ... in exact accordance with the Instructions for use given with the relevant system WI FI CONNECTION For the Wi Fi connection proceed as follows 1 Insert the Wi Fi key in the USB port 2 Read the Instructions for use provided with the Wi Fi key INSTALLING THE STERILIZER WARNING In case of sterilizer malfunctions immediately unplug the sterilizer and call for service Do not attempt to repair the steri...

Страница 21: ...he sterilizer POWER ON OFF THE STERILIZER 1 Press the power switch behind the service door the visual indicator on the power switch will turn green 2 After a quick autotest the sterilizer automatically turns in standby mode See Standby mode on page 33 3 Tap The homepage appears with the enabled sterilization cycles ...

Страница 22: ...CRIPTION Part Description A Title purpose of the screen or the cycle number and the current date and time B Available cycles Note The S Fast 134 cycle is optional activated with Fast Cycle activation code see S Fast 134 cycle activation on page 58 C Available tests D Additional buttons used to navigate the menu ...

Страница 23: ...Getting started LARA Instructions for use RIL 1 ENG Rev04 28 02 2019 2019 W H Sterilization Srl 23 User interface menu STRUCTURE AND NAVIGATION optional with Activation code optional ...

Страница 24: ...ring 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 Language Sets the language Date Time Sets time and date values and format Sterilizer Name Sets the sterilizer name Energy management Sets the standby mode Display Sets the display brightness Cycle Opens the pages to manage cycles Measurement ...

Страница 25: ...terilization cycle reports in the USBpen drive User Management Optional activated with an activation code Permits manage the users Add User Administrator only Adds a user Icon Label Function Delete User Administrator only Deletes a user Reset user PIN code Administrator only Resets a user PIN code Change your PIN code Changes the PIN code Options Optional activated with an activation code Administ...

Страница 26: ... connected to the sterilizer Special Codes Saves the codes issued by the manufacturer to activate special functions See Activation codes on page 127 MAINTENANCE MENU FUNCTIONS Icon Label Function Bact Filter Shows the status of the bacteriological filter for replacement and resets its counter to zero Icon Label Function Dust Filter Shows the status of the dust filter for replacement and resets its...

Страница 27: ...aking any changes nor saving any parameters n Answers NOto a question Indicates that the AUTODRYmode is operating Optional activated with an activation code Indicates that the ECODRYplus mode is operating Increases decreases the value Icon Function Indicates that an error occurs Indicates that the option checked is working properly n Plays a video n Starts a procedure Pauses a video Indicates that...

Страница 28: ...at the option is active not active Indicates that the option is enabled disabled Indicates that the user is using the administrator credentials Confirms the active option and saves a setting or a parameter Copy the system info to the USBpen drive Shows an animation about the replacement procedure Shows a sterilization summary ...

Страница 29: ...efer 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 30: ...r name that appears in the cycle reports 1 On the homepage tap 2 Tap the text box a keyboard appears 3 Enter the new sterilizer name 4 Tap to confirm 5 Tap to go back to the previous page SET THE DISPLAY BRIGHTNESS To change the display brightness 1 On the homepage tap 2 Tap or to change the value 3 Tap to confirm and go back to the previous page ...

Страница 31: ...he data the frames highlight If a frame turns dark grey check and correct the entered data User authentication optional FUNCTION AVAILABILITY To access the user management functions the Traceability activation code must be entered The activation code is required only at the first access to the User Management or the Options menus To acquire the activation code please refer to the Activation code i...

Страница 32: ...o go back to the previous page WHAT TO DO IF YOU FORGET YOUR PIN If you are Then contact a common user the administrator the administrator your authorized service provider USB pen drive DESCRIPTION A USB pen drive is available to be installed in order to automatically record all the sterilization cycle reports The USB pen drive can be inserted equally into the front or rear port optional Notice Pe...

Страница 33: ... 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 STAND...

Страница 34: ...28 02 2019 2019 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 35: ...entered The activation code is required only at the first access to the User Management or the Options menus To acquire the activation code please refer to the Activation code instructions Note If you have entered the All in One activation code in Special Codes menu the function is already available WHO CAN MANAGE USERS AND RESET THEIR PIN Only a user with administrator rights can create and delet...

Страница 36: ... 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 37: ...p 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 38: ...tivation code instructions Note If you have entered the All in One activation code in Special Codes menu the function is already available WHO CAN SET THE TRACEABILITY OPTIONS Only a user with administrator rights can set the traceability options SET THE TRACEABILITY 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 ...

Страница 39: ...inter 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 pr...

Страница 40: ...o 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 Note Function available only if the LAN Wi Fi connection has been activated optional 1 Ensure the sterilizer to which the printer ...

Страница 41: ... confirm the printer sharing 10 Tap to print a test label again 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 an a...

Страница 42: ...c 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 44 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 previous...

Страница 43: ...9 W H Sterilization Srl 43 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 44: ...lease 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 n...

Страница 45: ...RMED 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 49 Vacuum test Validate the sterilizer performance in terms of n efficiency of the vacuum pump n tightness of the pneumaticcircuit See Vacuum test on pa...

Страница 46: ...acket 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 Do not remove the standard chamber accessories mounted e g chamber rack and trays 2 Place the Bowie and Dick test pac...

Страница 47: ... 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 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 pack and check the change in colour See Inte...

Страница 48: ...SULT 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 49: ...ne 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 Do not remove the standard chamber accessories mounted e g chamber rack and trays 2 Unscrew th...

Страница 50: ... 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 51: ...See Interpret the test result below INTERPRET THE TEST RESULT Indicator What happened Test passed What to do next The indicator strip has 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 th...

Страница 52: ...THE TEST The test is used to validate the sterilizer performance in terms of n efficiency of the vacuum pump n tightness of the pneumatic circuit DESCRIPTION It consists of a vacuum phase followed by a stabilization period of 5 minutes and a testing period of 10 minutes The internal pressure is monitored during the testing period The pressure rise must be less than 0 013 bar 0 19 psi CARRY OUT THE...

Страница 53: ...st and tap OPEN the chamber door unlocks 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 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...

Страница 54: ...bricated 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 disinfecti...

Страница 55: ...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 111 Never place the load or the trays directly into the chamber without the chamber rack as this could affect the stea...

Страница 56: ... 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 three ...

Страница 57: ...in 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 other trays from the chamber Sterilization cycle description AVAILABLE STERILIZATION CYCLES See Sterilization cycles on page 111 for the full list of...

Страница 58: ...he manufacturer and tap to confirm Sterilization cycle management S FAST 134 CYCLE ACTIVATION Note If you have entered the All in One activation code in Special Codes menu the function is already available To activate the S Fast 134 cycle is required the Fast Cycle activation code To require the activation code please refer to the Activation code instructions To activate the cycle proceed as follo...

Страница 59: ...gently closed until step 7 6 Tap and enter your credentials if required the door locks If you have not set a different start time the sterilization starts immediately 7 Wait the end of the sterilization Tap to view the cycle parameters in real time See View the cycle parameters on page 62 8 The sterilization is completed Tap to view the cycle summary or tap to view the cycle information See View t...

Страница 60: ...next morning before office hours You can set the cycle start date and time and enable or disable it for each cycle 1 On the homepage tap the cycle 2 To change the start time tap Start cycle at 3 Tap the time or the date a settings page opens 4 Tap the number you want to change and tap or to increase it or decrease it 5 Tap to confirm and go back to the previous page 6 Tap to lock the door and star...

Страница 61: ...abled the AUTO DRY and ECO DRY plus modes first 1 On the homepage tap the cycle and 2 Select Fixed to disable the automatic drying mode 3 Tap the wording Fixed to modify the fixed mode minutes 4 Tap or to increase the minutes or decrease them Note for the minimum value of the drying time for each cycle see Sterilization cycles on page 111 5 Tap to confirm and go back to the previous page This beco...

Страница 62: ...s running or when cycle ends tap the cycle information page opens 2 Tap or to scroll the pages STERILIZATION CYCLE PAGE Following are the information displayed while a cycle is running Part Description A Sterilization cycle name B Drying mode enabled C Countdown clock time until the cycle completion D chamber pressure cycle counter chamber temperature E Date and time and door securely locked symbo...

Страница 63: ...home page appears Note if an error message appears see Troubleshooting on page 106 CAUTION Hot surfaces Burnings Do not touch the chamber the internal side of the door and the internal fittings Use the tray holder or cassette holder or gloves for high temperatures or adequate protection to remove the load 3 Open the chamber door 4 Remove the load and stock it STOP A STERILIZATION CYCLE WARNING You...

Страница 64: ...takes some time to reset the system and reach safe conditions in the sterilizer chamber 4 Check the message See Messages of a stopped sterilization cycle on the next page 5 Tap to view the cycle parameters See View the cycle parameters on page 62 6 Open the chamber door 7 Reprocess the load if necessary CAUTION Hot steam Wait the steam to dissipate before opening the door Note Water could be prese...

Страница 65: ...rts can also be saved on the USB pen drive STORED REPORT FORMAT The summarized reports are stored in HTML format and the analytical reports in SCL format All parameters are recorded every second WHAT HAPPENS WITH UNSAVED CYCLES If for any reason e g USB memory full USB pen drive disconnected etc some cycles cannot be saved no alert is shown If still stored in memory the unsaved cycles will be copi...

Страница 66: ...homepage tap 2 Scroll the list and tap the desired sterilization cycle the report opens 3 Tap 4 Tap to print the report or tap to save the report on the USB pen drive PRINT LABELS FOR A SPECIFIC CYCLE Note Function available only with the Label printer activation code 1 On the homepage tap 2 Scroll the list and tap the desired sterilization cycle the report opens ...

Страница 67: ...crease the number of label to be printed 6 Tap to save the set number for the 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 drive depends upon the USB capacity To save all the cycle reports 1 On the homepage tap 2 Tap after the confirmation all sterilization cycle reports are stored in the USB ...

Страница 68: ...folder followed by the sub folder name if any where to save reports Do not enter the full path Note The folder name must include letters and numbers only Do not use other characters like space bar slash accent etc 4 Enter the host name or the IP address if the data are complete the fields highlight 5 Not mandatory Enter the domain name 6 Tap to require the authentication credentials to access the ...

Страница 69: ...ence of tests is automatically performed 3 In case an error occurs correct it and tap to repeat the test 4 Tap to go back to the previous page SAVE ALL THE CYCLE REPORTS IN A REMOTE FOLDER OPTIONAL Note The save all function is available only if the remote data storage is enabled See Set the remote folder for saving the reports optional on the previous page Only the last 400 cycles in HTML and 100...

Страница 70: ... 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 PP3 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 71: ...RIL 1 ENG Rev04 28 02 2019 2019 W H Sterilization Srl 71 Sterilization cycles Data Description Cycle time Cycle time Date below Cycle end date and time Cycle completed Cycle outcome Trk Tracking code for traceability management ...

Страница 72: ...ated door opening tool 96 Disposal 99 Warnings for maintenance operations WARNINGS WARNING Turn the sterilizer OFF and remove the power cord before beginning any maintenance Follow all health safety cross infection and cross contamination protocols Maintenance operation shall be done at illumination level of 215 lx 15 lx to 1500 lx 15 lx Before making any operation ward off unauthorized personnel ...

Страница 73: ... See 800 cycle maintenance on page 89 5 years 4000 General check and service See 4000 cycle or five year maintenance on page 91 Note 1 Whichever occurs first Note 2 Even if the maximum cycle number is not reached it is recommended to replace the consumable parts every year or if they appear worn or damaged or if the filters are clogged or discolored EXPIRED MAINTENANCE The sterilizer monitors the ...

Страница 74: ...s 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 75: ...an 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 star...

Страница 76: ...e 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 wash...

Страница 77: ...19 W H Sterilization Srl 77 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 78: ...04 28 02 2019 2019 W H Sterilization Srl 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 79: ...ilization Srl 79 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 80: ... 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 74 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 81: ...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 74 Proceed as follows 1 Open the chamber door 2 Pull out the dust filter handle from underneath the sterilizer 3 Lift the used filter from the handle and remove it ...

Страница 82: ...tenance 82 LARA Instructions for use RIL 1 ENG Rev04 28 02 2019 2019 W H Sterilization Srl 4 Insert the new filter into the handle 5 Slide the handle back into its original position 6 Close the chamber door ...

Страница 83: ...e water tanks below 2 Access to the water tanks on the next page 3 Clean the water tanks on page 86 PREPARE THE STERILIZER FOR CLEANING THE WATER TANKS 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 92 3 To drain the detergent solution during the subsequent cleaning leave the drain...

Страница 84: ...Maintenance 84 LARA Instructions for use RIL 1 ENG Rev04 28 02 2019 2019 W H Sterilization Srl ACCESS TO THE WATER TANKS Proceed as follows 1 Lift the water tank cover ...

Страница 85: ...19 W H Sterilization Srl 85 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 86: ...d 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 internal tank surfaces 4 Detach the drain...

Страница 87: ...LARA Instructions for use RIL 1 ENG Rev04 28 02 2019 2019 W H Sterilization Srl 87 5 Remove the internal filters 6 Clean the metal cartridges of the internal filters with tap water 7 Reposition the internal filters ...

Страница 88: ...Maintenance 88 LARA Instructions for use RIL 1 ENG Rev04 28 02 2019 2019 W H Sterilization Srl 8 Reposition the internal tank cover and then the water tank cover 9 Detach the drain tube ...

Страница 89: ...able before the maintenance due date you have to reset the cycle counter See Replace the consumable before the maintenance due date on page 74 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 free cloth 4 Moisten the new seal with water to facilitate its placement ...

Страница 90: ...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 52 and Helix test on page 49 ...

Страница 91: ...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 Ch...

Страница 92: ...zer 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 re...

Страница 93: ...izer 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 94: ...v04 28 02 2019 2019 W H Sterilization Srl 3 Open the chamber door 4 Remove the dust filter and move the sterilizer closer to the shelf edge 5 Push the reset button of the thermostat switch a click sound indicates that the thermostat switch has been reset ...

Страница 95: ...nto its original position 7 Close the chamber door 8 Connect the mains cable and place the sterilizer back into its original position 9 Switch the sterilizer ON 10 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 96: ...ION High temperature Risk of burns Execute the following procedure only when the sterilizer has completely cooled down The sterilizer should be unplugged from the mains power supply since 3 hours at least Notice Execute 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 TOO...

Страница 97: ...ions for use RIL 1 ENG Rev04 28 02 2019 2019 W H Sterilization Srl 97 2 Take the auxiliary cable loom included in the sterilizer box 3 Firmly open the service door 4 Unscrew the bacteriological filter by hand counter clockwise ...

Страница 98: ...H Sterilization Srl 5 Plug two batteries into the connectors 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 ...

Страница 99: ... 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 compone...

Страница 100: ...NG Rev04 28 02 2019 2019 W H Sterilization Srl Diagnostic CONTENTS This section deals with the following subjects Errors 100 Troubleshooting 106 Errors CHECKS AND ACTIONS Notice For any error not listed in this table call technical service ...

Страница 101: ...k 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 is not blocked 10x See error 13xto 16x on the next page Repeat the cycle If the problem persists call service 12x Wait before opening the chamber door Allow the sterilization chamber...

Страница 102: ...hemicals 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 above Repeat the cycle If the problem persists call service Bacteriological filte...

Страница 103: ...ycle If the problem persists call service 5xx Check if there are hurdles on the door locking area chamber rack loads objects Repeat the cycle If the problem persists call service Check the door seal 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 MESSAG...

Страница 104: ... 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 the pre alert will appear again after some cycles See Maintenance on page 72 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 cyc...

Страница 105: ...be replaced Replace the consumable and tap to reset the counter See Maintenance on page 72 If you don t replace the consumable press In this case 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 bacteri...

Страница 106: ...ilizer 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 of ...

Страница 107: ...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 be w...

Страница 108: ...e the door seal Clean the chamber face side Internal leak Call technical service The cycle commences but there is no pressure temperature rise The thermal overload switch is open Reset the thermal overload switch See Extraordinary maintenance on page 92 Electric electronicfault Call technical service At the end of the cycle there is residual water in the chamber Sterilizer not properly leveled Pro...

Страница 109: ...m See Load maintenance and preparation on page 54 Scale deposits on the chamber Clean the chamber and use water of good quality See Water quality on page 122 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 Print...

Страница 110: ...cle the display reads Open the door but opening the door is impossible The chamber is in vacuum due to an internal malfunction See Battery operated door opening tool on page 96 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...

Страница 111: ...he 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 t...

Страница 112: ... cycles such as textiles and plastics S S Fast 134 optional 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 ...

Страница 113: ...B simple hollow item n Dental load 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 other factors Values and cycle names could be different depending on country requirements Load Empty Full Typical LARA 17 LARA 22 LARA 17 LARA 22 LARA 17...

Страница 114: ...5 kg 12 1 lbs 1 5 kg 3 3 lbs 2 0 kg 4 4 lbs BExtended 134 4 5 kg 10 lbs 5 5 kg 12 1 lbs 4 5 kg 10 lbs 5 5 kg 12 1 lbs 1 5 kg 3 3 lbs 2 0 kg 4 4 lbs BUniversal 121 4 5 kg 10 lbs 5 5 kg 12 1 lbs 4 5 kg 10 lbs 5 5 kg 12 1 lbs 1 5 kg 3 3 lbs 2 0 kg 4 4 lbs S Fast 134 optional 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 AUTO DRY and ECO DR...

Страница 115: ...on 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 DRY Vacuum drying SEP Water separation LEV Leveling Pressure inside the sterilization chamber is leveled t...

Страница 116: ...4 28 02 2019 2019 W H Sterilization Srl 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 117: ...zation Srl 117 TYPE S STERILIZATION CYCLE PHASES OPTIONAL 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 118: ...stem according to EN13060 Programmable standby mode Max heat output 3000 kJ h 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 ...

Страница 119: ...ote Usable space with standard rack and trays With optional tracks and trays see Accessories spare parts consumables on page 123 STEAM GENERATOR Pressure safety valve 5 bar 72 51 psig Safety thermostats 230 C 446 F DISTILLED OR DEMINERALIZED WATER Water quality Fulfilling EN 13060 Ann C conductivity 15μS cm Average water consumption 0 13 to 0 59 litres cycle 0 03 to 0 16 gal cycle Tank volume Clea...

Страница 120: ...chnical data Recommendations for validation TEST VALIDATION POINTS LARA sterilizers can be validated in accordance to EN17665 1 For further details please refer to the Qualification Validation guide for sterilization cycles of W H sterilizer Part Description Hottest points Coldest points ...

Страница 121: ...Sterilization Srl 121 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 118 ...

Страница 122: ...ty 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 disinfectio...

Страница 123: ... x312 n 188 x22 x312 F523031x Note rack rotated 90 Standard chamber rack for 3 cassettes containers for LARA 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 LARA 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 rotated ...

Страница 124: ...3012x Optional chamber rack for 4 cassettes containers for LARA 22 Usable space Cassette size mm n 190 x32 x300 375 n 210 x32 x300 375 n 210 x32 x300 375 n 190 x32 x300 375 F523015x Picture Part Part number Optional chamber rack for 2 cassettes containers for LARA 17 Usable space Cassette size mm n 190 x70 x300 375 n 190 x70 x300 375 F523016x Optional chamber rack for 2 cassettes containers for LA...

Страница 125: ... 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 LARA 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 LARA 22 Usable space Cassette size mm n 190 x50 x400 n 190 x50 x400 n 19...

Страница 126: ...inter 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 Dist water distiller 19723101 Picture Part Part number Multidem C27 water demineralizer 19723112 Osmo water demineralizer osmoticprinciple 19723100 Safety bracket kit X051125X Auxiliary cable loom F3721060 Kit helixtest PCD pl...

Страница 127: ...onents n 1 door seal n 2 bacteriological filters n 2 dust filters X050328X Refer to each single component above 250 helixstrips T800205x Before stocks are exhausted ACTIVATION CODES Activation code Description Part number Performance Activates the ECODRYplus drying mode 19730001 Fast Cycle Activates the S Fast 134 cycle 19730002 Traceability Activates the User Management and Options menus 19730003...

Страница 128: ... 15 Fax 90 216 216 505 88 43 E mail address service tr wh com Serbia COMMEX DOO Kornelija Stankovića 31 21000 Novi Sad Phone Fax 021 511 073 021 511 075 M 063 526 949 063 77 87 427 E mail address commex eunet rs commex bg gmail com Website www CommexDental com Spain Portugal WEHADENT IBERICA S L C Ciudad de Melilla 3 Bajo E 46017 Valencia Phone 34 96 3532020 Fax 34 96 3532579 E mail address servic...

Страница 129: ...land GmbH Raiffeisenstraße 3b D 83410 Laufen Phone 49 8682 8967 0 Fax 49 8682 8967 11 E mail address office de wh com Austria W H Austria GmbH Ignaz Glaser Straße 53 A 5111 Bürmoos Phone 43 6274 6236 239 Fax 43 6274 6236 890 E mail address service dept wh com Danmark Finland Iceland Norway Estonia Sweden Lithuania Latvia W H NordicAB Linjalvägen 10E S 187 66 Täby Phone 46 8 445 84 30 Fax 46 8 445 ...

Страница 130: ...株式会社福岡営業所 812 0013 福岡市博多区博多駅東2 18 30八重洲博多ビル5F 092 432 4618 092 432 4617 Switzerland W H CH AG Industriepark 9 CH 8610 Uster ZH Phone 41 43 4978484 Fax 41 43 4978488 E mail address info ch wh com Belgium Luxembourg Lisa Service Benelux Danny Spelmans Phone 32 0 474 942 769 E mail address lisaservice benelux wh com Australia A DEC AUSTRALIA CO INC Unit 8 5 9 Ricketty Street Mascot NSW 2020 Phone 6...

Страница 131: ...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 which w...

Страница 132: ... 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 a...

Страница 133: ... H Sterilization Srl 133 Documentation forms ADDRESSES FOR SENDING THE INSTALLATION CHECK LIST Send a copy of the compiled installation check list to both of the following addresses Fax 43 6274 6236 55 Mail Ignaz Glaser Straße 53 Postfach 1 5111 Bürmoos Austria ...

Страница 134: ...tion 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 135: ... LARA Instructions for use RIL 1 ENG Rev04 28 02 2019 2019 W H Sterilization Srl 135 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 136: ...tion forms 136 LARA Instructions for use RIL 1 ENG Rev04 28 02 2019 2019 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 137: ......

Страница 138: ...Manufacturer W H Sterilization Srl via Bolgara 2 Brusaporto BG Italy www wh com 39 035 66 63 000 RIL 1 Instructions for use ENG Rev04 28 02 2019 Subject to changes ...

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