W&H Lyla, Instructions For Use Manual

Page 1: ...RIN 210 17 RIN 210 22 Instructions for Use RIN 210 ENG Rev02...

Page 2: ......

Page 3: ...nagement optional 34 Traceability options optional 35 Managing printers 36 Printer selection optional 36 Label printer selection optional 36 Label printer usage optional 37 Label content description 3...

Page 4: ...rors 82 Troubleshooting 87 Emergency door opening 93 Technical data 96 Sterilization cycles 96 Sterilization cycle phases 102 Technical data 105 Recommendations for validation 107 Diagrams 108 Water q...

Page 5: ...conformity to the ANNEX 1 and to the procedure described in the moduleD1 Annex III 2012 19 EU Waste Electrical and Electronic Equipment Directive WEEE EN 13060 Small steam sterilizers IEC 61010 1 Safe...

Page 6: ...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...

Page 7: ...with HIBC Standard Small Steam Sterilizer This side up Fragile handle with care Keep dry The sterilizer must be transported by two authorized technicians due to its heavy weight ON supply IEC 60417 5...

Page 8: ...s 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 decommissi...

Page 9: ...dical ones The small steam sterilizers are intended for the sterilization in veterinary practices They are also intended to be used for materials and equipment which are likely to come into contact wi...

Page 10: ...s 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...

Page 11: ...g precautions have been taken n the access to the device operating system is not possible user access to the operating system is disabled n a firewall is active on the device all the device network co...

Page 12: ...n The Instructions for Use updated to the latest version is always available at www wh com n Keep these Instructions for Use for future reference MANUFACTURER RESPONSIBILITY n The manufacturer can on...

Page 13: ...description 17 Installing the sterilizer 21 Operating the sterilizer 23 User interface menu 24 Sterilizer setup 30 User authentication optional 31 USB pen drive 32 Standby mode 32 Unpacking UNPACK THE...

Page 14: ...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 pr...

Page 15: ...THE STERILIZER The following items are not provided n Water container to capture waste water during manual tank draining volume larger than 5 l 1 3 gal n LAN cable for connecting the sterilizer to a n...

Page 16: ...ctions for Use RIN 210 ENG Rev02 15 09 2022 W H Sterilization Srl Getting started n Use original packaging when shipping or transporting the sterilizer Replacement packaging materials are available fr...

Page 17: ...E Part Description A Chamber door B Tank C Water level sensor D Water tank cover E Tank filling cover cap F Water tank cover G Internal tank cover H Tank internal filters with metal cartridges I Touch...

Page 18: ...NG Rev02 15 09 2022 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...

Page 19: ...9 2022 W H Sterilization Srl 19 REAR VIEW Part Description A USB port optional B Air gap cover C Test connection D Pressure safety valve cover E Used water drain optional F Water supply inlet optional...

Page 20: ...2 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 rota...

Page 21: ...The sterilizer must operate in absence of explosive atmospheres The sterilizer must operate in a well ventilated room indoor far from sources of heat and from flammable materials Place the sterilizer...

Page 22: ...Use given with the relevant system WI FI CONNECTION OPTIONAL For the Wi Fi connection proceed as follows 1 Insert the Wi Fi dongle key in the USB port 2 Read the Instructions for Use provided with th...

Page 23: ...quick autotest the sterilizer automatically turns in Standby mode See Standby mode on page 32 Note at the first start up of the sterilizer the Guided Configuration procedure automatically appears see...

Page 24: ...management Traceability Opens the pages to n monitor the performed cycle data n manage users n set the label printing options Accessories Opens the pages to accessories management Maintenance Carries...

Page 25: ...con Label Function IoDent Only if this service is supported in the country of use and if the sterilizer is connected to it Shows the status of the connection with the W H monitoring server Eliso Statu...

Page 26: ...user Delete User Administrator only Deletes a user Reset user PIN code Administrator only Resets a user PIN code Icon Label Function Change your PIN code Changes the PIN code Options Optional activate...

Page 27: ...the printer model connected to the sterilizer The icon appears disabled if the printer Ethernet cable Wi Fi dongle key is not connected Special Codes Saves the codes issued by the manufacturer to act...

Page 28: ...swers YES to a question n Aborts the action function n Moves to the previous screen without confirming making any changes nor saving any parameters n Answers NO to a question Indicates that the AUTO D...

Page 29: ...the user is using the administrator credentials Gives information about the function displayed Confirms the active option and saves a setting or a parameter Copies the system info to the USB pen driv...

Page 30: ...tap 2 Follow the Guided Configuration on the sterilizer screen SET THE LANGUAGE 1 On the homepage tap 2 Tap the language you prefer 3 Tap to confirm and go back to the homepage SET THE DATE AND TIME T...

Page 31: ...he connectivity means 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 isn t visible if you connect th...

Page 32: ...u are a common user contact the administrator you are the administrator contact your authorized service provider USB pen drive DESCRIPTION A USB pen drive is available to be installed in order to auto...

Page 33: ...certain period of time it automatically switches to Standby mode ENTER THE STANDBY MODE MANUALLY 1 Homepage 2 Tap EXIT THE STANDBY MODE Tap or open or close the chamber door CHANGING STANDBY MODE DELA...

Page 34: ...gain To acquire the activation code please refer to the Activation code instructions WHO CAN MANAGE USERS AND RESET THEIR PIN Only a user with administrator rights can create and delete users and rese...

Page 35: ...the User Management activation code must be entered The activation code is required only at the first access to the User Management or the Options menus after the code was entered the function is enab...

Page 36: ...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 t...

Page 37: ...m herself with password if required and the load has been checked and released if these options have been enabled by the administrator For the automatic label printing a maximum storage time in weeks...

Page 38: ...se 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...

Page 39: ...ON THE STERILIZER Test Purpose Reference Bowie and Dick test Validate the sterilizer performance for textile load sterilization See Bowie and Dick test below Helix test Validate the sterilizer perfor...

Page 40: ...ormance for textile load sterilization DESCRIPTION It consists of several sheets of paper wrapped in a small packet with a chemical heat sensitive indicator sheet in the middle The colour assumed by t...

Page 41: ...on of the Plateau Sterilization phase and other settings tap 5 Tap and enter your credentials if required the chamber door locks 6 Wait until the end of the test and tap OPEN the chamber door unlocks...

Page 42: ...T Indicator What happened Test passed What to do next The entire surface of the indicator sheet has changed colour Yes Certain areas of the indicator sheet have not changed colour since there was an a...

Page 43: ...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 TH...

Page 44: ...the tube CAUTION Risk of burns The tube is very hot at the end of the cycle Wear appropriate PPE e g gloves 11 Unscrew the tube capsule and remove the indicator strip 12 Check the change in colour Se...

Page 45: ...sists 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 t...

Page 46: ...2 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...

Page 47: ...icated 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...

Page 48: ...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 cha...

Page 49: ...fferent materials stainless steel carbon steel aluminium etc On separate trays or wrapped pouched Instruments manufactured from carbon steel Place paper among them and the trays to avoid rusty spots P...

Page 50: ...3 Reposition the tank filling cover cap INSERTING THE CHAMBER RACK INTO THE STERILIZER CAUTION Risk of burns Before touching the chamber rack or contents ensure the sterilization chamber is not hot 1...

Page 51: ...Sterilization cycle management B TYPE CYCLES ACTIVATION Note If you have entered the All in One activation code in Special Codes menu the function is already available To activate the B type cycles i...

Page 52: ...te 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...

Page 53: ...rilization cycle is 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 runni...

Page 54: ...remove the load 3 Open the chamber door 4 Remove the load and stock it STOP A STERILIZATION CYCLE WARNING You can stop the cycle at any time Instruments must not be considered sterile if this occurs b...

Page 55: ...ed 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 UNSAVE...

Page 56: ...tion cycle reports are stored in the USB SET THE REMOTE FOLDER FOR SAVING THE REPORTS OPTIONAL Function availability The first time you access the Remote Data Storage menu you will be requested to ent...

Page 57: ...e 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 to repeat the test sequence if the error persists call your IT m...

Page 58: ...me 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 sta...

Page 59: ...RIN 210 ENG Rev02 15 09 2022 W H Sterilization Srl 59 Sterilization cycles Data Description Cycle time Cycle time Date below Cycle end date and time Cycle completed Cycle outcome Trk Tracking code fo...

Page 60: ...e 80 Disposal 81 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 cr...

Page 61: ...79 1 whichever occurs first 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 clog...

Page 62: ...62 Lyla Instructions for Use RIN 210 ENG Rev02 15 09 2022 W H Sterilization Srl Maintenance 3 When you have replaced the consumable tap to confirm the executed cycle counter is reset...

Page 63: ...AND THE CHAMBER FACE SIDE Proceed as follows 1 Clean the gasket seat and the chamber face side with a damp lint free cloth moistened with clean water Notice Do not use abrasive products cutting tools...

Page 64: ...to bend or damage the temperature probe inside the sterilizer chamber 3 Rinse with water 4 Clean the trays the chamber rack and the steam diffuser plate with a damp sponge and a mild detergent soluti...

Page 65: ...W H Sterilization Srl 65 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 fil...

Page 66: ...ev02 15 09 2022 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 c...

Page 67: ...XTERNAL SURFACES OF THE STERILIZER Proceed as follows 1 Clean all external sterilizer covers with a slightly damp cloth moistened with water For better cleaning results clean with W H MC 1000 cleaning...

Page 68: ...otice 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 61 Proceed as follows 1 Open...

Page 69: ...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 61 Proceed as follows 1 Open the cha...

Page 70: ...tenance 70 Lyla Instructions for Use RIN 210 ENG Rev02 15 09 2022 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 d...

Page 71: ...er tanks below 2 Access to the water tanks on the next page 3 Clean the water tanks on page 74 PREPARE THE STERILIZER FOR CLEANING THE WATER TANKS Proceed as follows 1 Switch OFF the sterilizer and di...

Page 72: ...Maintenance 72 Lyla Instructions for Use RIN 210 ENG Rev02 15 09 2022 W H Sterilization Srl ACCESS TO THE WATER TANKS Proceed as follows 1 Lift the water tank cover...

Page 73: ...W H Sterilization Srl 73 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 o...

Page 74: ...e moistened with water For better cleaning results clean with W H MC 1000 cleaning solution Use a small non abrasive brush to clean the areas that are difficult to reach Notice never use any other dis...

Page 75: ...Lyla Instructions for Use RIN 210 ENG Rev02 15 09 2022 W H Sterilization Srl 75 5 Remove the internal filters 6 Clean the metal cartridges of the internal filters with tap water 7 Reposition the inter...

Page 76: ...Maintenance 76 Lyla Instructions for Use RIN 210 ENG Rev02 15 09 2022 W H Sterilization Srl 8 Reposition the internal tank cover and then the water tank cover 9 Detach the drain tube...

Page 77: ...le before the maintenance due date you have to reset the cycle counter See Replace the consumable before the maintenance due date on page 61 Proceed as follows 1 Fully open the chamber door 2 Remove t...

Page 78: ...ress 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 an...

Page 79: ...rnal 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...

Page 80: ...t 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 us...

Page 81: ...f 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...

Page 82: ...ion Actions 0xx Load cannot be considered sterile See End of a sterilization cycle on page 54 Repeat the cycle If the problem persists call service Check if the mains switch or network circuit breaker...

Page 83: ...he 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...

Page 84: ...load does not exceed the MAXIMUM WEIGHT LIMITS 4xx Clean water error bad quality or low water level Drain and refill the clean water tank Repeat the cycle If the problem persists call service 5xx Che...

Page 85: ...e water The clean water quality is very bad conductivity more than 50 S cm Running a cycle is inhibited to prevent damage Replace the clean water Door Gasket must be replaced in cycles Have you ordere...

Page 86: ...maintenance step is to be performed Call technical service for the 4000 cycle maintenance Possible leak detected Please run Vacuum Test Air was detected in the chamber a vacuum leak is suspected The...

Page 87: ...g place a towel below the chamber door VIEW AND SAVE THE ERROR LOG 1 On the homepage tap a list of the last errors appears 2 Tap to save the list in the USB pen drive ERROR PAGE During the sterilizati...

Page 88: ...use 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 th...

Page 89: ...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 e...

Page 90: ...hamber 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...

Page 91: ...e Load maintenance and preparation on page 47 Scale deposits on the chamber Clean the chamber and use water of good quality See Water quality on page 109 Instruments are turning brown or black Incorre...

Page 92: ...e the display reads Open the door but opening the door is impossible The chamber is in vacuum due to an internal malfunction See Emergency door opening on the next page Switch the sterilizer OFF this...

Page 93: ...erious risk CAUTION High temperature Risk of burns Carry out the following procedure only when the sterilizer has completely cooled down The sterilizer should be unplugged from the mains power supply...

Page 94: ...2 W H Sterilization Srl OPEN THE DOOR IN EMERGENCY 1 Unplug the sterilizer and wait at least three hours 2 Take the emergency door opening tool included in the sterilizer box 3 Firmly open the service...

Page 95: ...ilization Srl 95 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 unp...

Page 96: ...imum 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...

Page 97: ...rilization time if this is required for your load or mandated in your country B available only with Activation Code B Universal 134 For all your general items like hand instruments handpieces forceps...

Page 98: ...ccording to EN ISO 17665 3 STERILIZATION CYCLE DATA B TYPE CYCLES AVAILABLE ONLY WITH ACTIVATION CODE Sterilization cycles B type cycles available only with Activation Code B Universal 134 B Prion Ext...

Page 99: ...oad Empty Full Typical 2 0 kg Eco 0 5 kg Lyla 17 Lyla 22 Lyla 17 Lyla 22 Lyla 17 Lyla 22 Lyla 17 Lyla 22 S Unwrapped 134 20 21 26 27 23 24 S Wrapped 134 38 39 45 46 42 43 S Gentle 121 61 62 64 66 63 6...

Page 100: ...rous n load weight n vacuum generation n duration of the drying phase n other factors Load Empty Full Typical 2 0 kg Eco 0 5 kg Lyla 22 Lyla 22 Lyla 22 Lyla 22 S Unwrapped 134 28 35 30 S Wrapped 134 4...

Page 101: ...5 kg 0 5 kg 0 5 kg B Prion Extended 134 only with AC 3 5 5 5 kg 1 4 0 6 0 kg 2 3 5 5 5 kg 1 4 0 6 0 kg 2 0 5 1 5 kg 3 0 5 2 0 kg 4 B Extended 134 ECO mode only with AC 0 5 kg 0 5 kg 0 5 kg 0 5 kg 0 5...

Page 102: ...re heating of the sterilizer This phase is not considered a part of the cycle HEA Heating phase heat the chamber and the load PV1 PV2 Vacuum pulse removal of air from the sterilizer chamber load PP1 P...

Page 103: ...ation Srl 103 TYPE S STERILIZATION CYCLE PHASES All S cycles feature the same pressure profile as shown in the graph below The temperature and the duration of the sterilization phase and the duration...

Page 104: ...15 09 2022 W H Sterilization Srl TYPE B STERILIZATION CYCLE PHASES OPTIONAL All type B sterilization cycles feature the same basic pressure profile as shown in the graph below The duration and the tem...

Page 105: ...trolled process evaluation system 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 rel...

Page 106: ...mm D 390 mm W 7 5 H 7 5 D 15 36 Bacteriological filter 0 3 m DISTILLED OR DEMINERALIZED WATER Water quality Fulfilling EN 13060 Ann C conductivity 15 S cm Total Dissolved Solids 10 ppm Average water c...

Page 107: ...l data Recommendations for validation TEST VALIDATION POINTS Lyla sterilizers can be validated in accordance to EN ISO 17665 1 For further details please refer to the Qualification Validation guide fo...

Page 108: ...ation Srl Diagrams CONNECTION DIAGRAMS Data communication Water system rear serial connection the water filtration system must be fitted with a backflow preventing device complying to IEC 61770 and to...

Page 109: ...at 20 C 15 S cm pH value 5 7 Appearance colorless clean free from sediment Contaminants minerals qualities Value Specification Hardness 0 02 mmol l Chemical additives No chemicals or additives must be...

Page 110: ...ce Tray size mm n 190 x 21 x 312 n 190 x 28 x 312 n 190 x 28 x 312 n 190 x 28 x 312 n 190 x 21 x 312 F523031X Note rack rotated 90 Standard chamber rack for 3 cassettes containers for Lyla 17 Usable s...

Page 111: ...tional chamber rack for 2 cassettes containers for Lyla 22 Usable space Cassette size mm n 190 x 78 x 385 n 210 x 78 x 385 F523017X Picture Part Part number Optional chamber rack for 3 cassettes conta...

Page 112: ...chamber rack for 3 cassettes containers for Lyla 22 Usable space Cassette size mm n 190 x 43 x 387 n 190 x 50 x 387 n 190 x 43 x 387 Picture Part Part number Optional chamber rack for 2 aluminium tra...

Page 113: ...nium tray for Lyla 17 186 x 19 5 x 287 mm F523204X Standard aluminium tray for Lyla 22 186 x 19 5 x 379 mm F523205X Large aluminium tray for Lyla 22 215 x 19 5 x 379 mm Suitable for F523035X F523211X...

Page 114: ...WF kit 19723112 Osmo water demineralizer 220 V Osmo water demineralizer 110 V only with AWF kit 19721134 19721135 Wi Fi dongle key 19721136 Lifting strap F602001X Emergency door opening tool F372106X...

Page 115: ...ers X050328X Refer to each single component above 250 Helix strips T800205X Before stocks are exhausted ACTIVATION CODES Activation code Description Part number B cycles Activates the B type cycles 19...

Page 116: ...pleteness of the Instructions for Use 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 coun...

Page 117: ...s 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 show...

Page 118: ...Sterilization Srl Documentation forms ADDRESSES FOR SENDING THE INSTALLATION CHECK LIST Send a copy of the installation check list duly filled in to both of the following addresses Fax 43 6274 6236 5...

Page 119: ...l 119 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 O...

Page 120: ...120 Lyla Instructions for Use RIN 210 ENG Rev02 15 09 2022 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 Ye...

Page 121: ...ation forms Lyla Instructions for Use RIN 210 ENG Rev02 15 09 2022 W H Sterilization Srl 121 Date Cycle n Operator Released Signature Chemical indicator Yes No Yes No Yes No Yes No Yes No Yes No Yes N...

Page 122: ...W H Sterilization Srl via Bolgara 2 Brusaporto BG Italy www wh com 39 035 66 63 000 RIN 210 Instructions for Use ENG Rev02 15 09 2022 Subject to changes...