W&H Med Lara, Instructions For Use Manual

Page 1: ...RIL 117 RIL 122 Instructions for Use RIL 1 W H Med ENG Rev06...

Page 2: ......

Page 3: ...management 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 descriptio...

Page 4: ...Errors 82 Troubleshooting 87 Emergency door opening 94 Technical data 97 Sterilization cycles 97 Sterilization cycle phases 102 Technical data 105 Recommendations for validation 107 Diagrams 108 Wate...

Page 5: ...1 Annex III 2012 19 EU Waste Electrical and Electronic Equipment Directive WEEE EN 13060 Small steam sterilizers IEC 61010 1 Safety requirements for electrical equipment for measurement control and la...

Page 6: ...ad 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 R...

Page 7: ...ep dry The sterilizer must be transported by two authorized technicians due to its heavy weight ON supply IEC 60417 5007 OFF supply IEC 60417 5008 IN position of bistable push control IEC 60417 5268 O...

Page 8: ...l 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 decommi...

Page 9: ...ilized 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...

Page 10: ...uids 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 t...

Page 11: ...device from external attacks It is recommended not to leave the machine unattended Note a list of security information is mentioned in the MDS2 document which is available on request Responsibility U...

Page 12: ...duct description 16 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 33 Unpacking UNPAC...

Page 13: ...n case of 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...

Page 14: ...Use This manual declaration of conformity warranty card work test report maintenance sheet ITEMS NOT PROVIDED WITH THE STERILIZER The following items are not provided n Water container to capture wast...

Page 15: ...TO RELOCATE THE STERILIZER Before transport n Completely drain both water tanks see Draining the used and clean water tank on page 80 n Allow the sterilization chamber to cool down n Use original pac...

Page 16: ...04 2022 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 f...

Page 17: ...ions for Use RIL 1 W H Med ENG Rev06 14 04 2022 W H Sterilization Srl 17 UPPER INTERNAL STRUCTURE Part Description A Tank B Water level sensor C Water tank cover D Internal tank cover E Tank internal...

Page 18: ...d ENG Rev06 14 04 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 wat...

Page 19: ...ed ENG Rev06 14 04 2022 W H Sterilization Srl 19 REAR VIEW Part Description A USB port B Air gap cover C Test connection D Pressure safety valve cover E Used water drain F Water supply inlet G Condens...

Page 20: ...2022 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 r...

Page 21: ...e atmospheres The sterilizer must operate in a well ventilated room indoor far from sources of heat and from flammable materials Place the sterilizer on a flat and level surface Notice If the steriliz...

Page 22: ...vant system WI FI CONNECTION 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 the Wi Fi dongle key INSTALLING THE...

Page 23: ...autotest the sterilizer automatically turns in Standby mode See Standby mode on page 33 Note at the first start up of the sterilizer the Guided Configuration procedure automatically appears see Steri...

Page 24: ...en drive and activate special functions Maintenance Carries out the maintenance procedure System Info n In general shows the system information n During a cycle shows the cycle parameters in real time...

Page 25: ...t Opens the page to manage the remote storage Settings Only with a network connection set Sets the parameters of the network location Save all Only with a network connection set Copies all the files i...

Page 26: ...ACCESSORIES MENU FUNCTIONS Icon Label Function USB Pen Drive Opens the formatting page of the USB pen drive Format Formats the USB pen drive Icon Label Function Label Printer Optional activated with a...

Page 27: ...27 Getting started Icon Label Function Door Gasket Shows the status of the door gasket for replacement and resets its counter to zero Device has completed 4000 cycles Shows the number of cycles perfor...

Page 28: ...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 DRY mod...

Page 29: ...r is using the administrator credentials Confirms the active option and saves a setting or a parameter Copies the system info to the USB pen drive Shows an animation about the replacement procedure Sh...

Page 30: ...mepage 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...

Page 31: ...f the connectivity means cable or Wi Fi dongle 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...

Page 32: ...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 US...

Page 33: ...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 STANDBY MODE MANUALLY 1 Homepage 2 Tap EX...

Page 34: ...enabled and there is no need to enter the code again To acquire the activation code please refer to the Activation code instructions WHO CAN MANAGE USERS AND RESET THEIR PIN Only a user with administ...

Page 35: ...LABILITY To access the user management functions 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 menu...

Page 36: ...he specific printer models available through manufacturer distributor 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 select...

Page 37: ...ase refer to the Activation code instructions provided with the label printer AUTOMATIC PRINTING OPTION The automatic printing option permits to automatically print a preset number of labels after a s...

Page 38: ...2022 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...

Page 39: ...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...

Page 40: ...MED 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 per...

Page 41: ...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 Note carry out...

Page 42: ...or locks 6 Wait until the end of the test and tap OPEN the chamber door unlocks 7 Enter your credentials if required 8 Open the chamber door extract the tray using the tray holder and take the test pa...

Page 43: ...SULT 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 a...

Page 44: ...nd 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...

Page 45: ...ther 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 10 Ope...

Page 46: ...g the whole lifespan of your sterilizer See Helix test documentation form on page 119 Vacuum test CAUTION Follow local national guidelines on the frequency of testing Notice If a drainage period of th...

Page 47: ...cuum test 4 Tap and enter your credentials if required the chamber door locks 5 Wait until the end of the test and tap OPEN the chamber door unlocks 6 Enter your credentials if required a message info...

Page 48: ...sed by chemicals CLEANING THE INSTRUMENTS Clean all instruments thoroughly prior to sterilization If possible clean instruments immediately after use always follow the instrument manufacturer s instru...

Page 49: ...ttes place them in the lowest rack position as there is more space height wise Pouched items On trays allowing adequate space in between bags Ensure that packs do not touch the walls of the chamber Pl...

Page 50: ...door and align the chamber rack at the center bottom of the chamber 2 Push the chamber rack gently into position until it clicks into place 3 Insert cassettes horizontally or vertically or insert tray...

Page 51: ...ion code The drying time is automatically adjusted to the shortest possible for the actual load weight and so it is more precise than the AUTO DRY drying time ECO DRY PLUS MODE ACTIVATION Note If you...

Page 52: ...ew the cycle information See View the cycle parameters on the next page 9 Tap OPEN the door unlocks 10 If required enter your credentials and confirm the release of the load if needed SET THE STERILIZ...

Page 53: ...on page 97 5 Tap to confirm and go back to the previous page This becomes the new fixed value CHANGE THE DRYING MODE The AUTO DRY mode is the default one To activate the ECO DRY plus mode see ECO DRY...

Page 54: ...to 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 occur...

Page 55: ...cles and the analytical reports of the last 5 cycles All reports can also be saved on the USB pen drive STORED REPORT FORMAT The summarized reports are stored in HTML format and the analytical reports...

Page 56: ...l printer activation code 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 5 Tap or to i...

Page 57: ...o access the remote storage folder and enter the user name and password 7 Tap to save 8 Tap to go back to the previous page 9 To check if the parameters entered are valid see Test the data storage opt...

Page 58: ...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...

Page 59: ...L 1 W H Med ENG Rev06 14 04 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...

Page 60: ...ance 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...

Page 61: ...r gasket See 800 cycle maintenance on page 77 5 years 4000 General check and service See 4000 cycle or five year maintenance on page 79 1 whichever occurs first 2 even if the maximum cycle number is n...

Page 62: ...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 s...

Page 63: ...maintenance CLEANING THE DOOR GASKET AND THE CHAMBER FACE SIDE Proceed as follows 1 Clean the seal seat and the chamber face side with a damp lint free cloth moistened with clean water 2 Rinse with c...

Page 64: ...he 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 cham...

Page 65: ...022 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...

Page 66: ...G Rev06 14 04 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 filte...

Page 67: ...E EXTERNAL 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 clean...

Page 68: ...R 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 62 Proceed as follows 1 O...

Page 69: ...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 62 Proceed as follows 1 Open the...

Page 70: ...ance 70 Lara Instructions for Use RIL 1 W H Med ENG Rev06 14 04 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 chambe...

Page 71: ...he water 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...

Page 72: ...Maintenance 72 Lara Instructions for Use RIL 1 W H Med ENG Rev06 14 04 2022 W H Sterilization Srl ACCESS TO THE WATER TANKS Proceed as follows 1 Lift the water tank cover...

Page 73: ...22 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 detergent...

Page 74: ...t sponge 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 ot...

Page 75: ...a Instructions for Use RIL 1 W H Med ENG Rev06 14 04 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 in...

Page 76: ...Maintenance 76 Lara Instructions for Use RIL 1 W H Med ENG Rev06 14 04 2022 W H Sterilization Srl 8 Reposition the internal tank cover and then the water tank cover 9 Detach the drain tube...

Page 77: ...mable before the maintenance due date you have to reset the cycle counter See Replace the consumable before the maintenance due date on page 62 Proceed as follows 1 Fully open the chamber door 2 Remov...

Page 78: ...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...

Page 79: ...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 F...

Page 80: ...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 dra...

Page 81: ...e 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...

Page 82: ...iption 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 brea...

Page 83: ...d 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...

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

Page 85: ...able 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 ord...

Page 86: ...the dust filter Device has completed 4000 cycles Please call your technical support to organize service This message advises you that the target of 4000 cycles has been achieved and the relevant maint...

Page 87: ...e 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 steriliz...

Page 88: ...lizer 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...

Page 89: ...Rev06 14 04 2022 W H Sterilization Srl 89 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 so...

Page 90: ...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 th...

Page 91: ...e 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 thermos...

Page 92: ...See Load maintenance and preparation on page 48 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 Incor...

Page 93: ...cycle 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 t...

Page 94: ...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 for at least 3 hours before executing...

Page 95: ...ns for Use RIL 1 W H Med ENG Rev06 14 04 2022 W H Sterilization Srl 95 2 Take the auxiliary cable loom included in the sterilizer box 3 Firmly open the service door 4 Unscrew the bacteriological filte...

Page 96: ...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...

Page 97: ...e 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 hazar...

Page 98: ...this is required for your load or mandated in your country B Universal 121 For all items that cannot withstand the high temperatures of the 134 cycles such as textiles and plastics S S Fast 134 For f...

Page 99: ...r g 2 04 bar 1 04 bar g 3 03 bar 2 03 bar g Duration of the Plateau Sterilization phase 5 30 20 30 20 30 3 30 Duration of the drying phase AUTO DRY and ECO DRY plus modes 5 22 5 22 5 28 0 4 Minimum du...

Page 100: ...ifferent elements such as the following n type of load solid or porous n load weight n other factors Load Empty Full Typical Lara 17 Lara 22 Lara 17 Lara 22 Lara 17 Lara 22 B Universal 134 26 30 29 30...

Page 101: ...kg 12 1 lbs 1 5 kg 3 3 lbs 2 0 kg 4 4 lbs B Prion Extended 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 B Universal 121 4 5 kg 10 lbs 5 5 kg 12 1 lbs...

Page 102: ...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...

Page 103: ...v06 14 04 2022 W H Sterilization Srl 103 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 temp...

Page 104: ...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 Thu...

Page 105: ...g 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...

Page 106: ...rd rack and trays With optional racks and trays see Accessories spare parts consumables on page 110 STEAM GENERATOR Pressure safety valve 5 bar 72 51 psi Safety thermostats 230 C 446 F DISTILLED OR DE...

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

Page 108: ...22 W H Sterilization Srl Diagrams CONNECTION DIAGRAMS Data communication Water system The water filtration system must be fitted with a backflow preventing device complying to IEC 61770 and to nationa...

Page 109: ...ty 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...

Page 110: ...applicable standards in the country of use LIST OF ACCESSORIES AND SPARE PARTS Picture Part Part number Standard chamber rack F523030X Standard chamber rack for 5 aluminium trays for Lara 17 Usable sp...

Page 111: ...6 x 300 F523020X Optional chamber rack for 3 cassettes containers for Lara 22 Usable space Cassette size mm n 205 x 36 x 385 n 210 x 36 x 385 n 205 x 36 x 385 F523021X Picture Part Part number Optiona...

Page 112: ...tated 90 Optional chamber rack for 3 cassettes containers for Lara 17 Usable space Cassette size mm n 190 x 43 x 312 n 190 x 50 x 312 n 190 x 43 x 312 Picture Part Part number Optional chamber rack fo...

Page 113: ...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 6 aluminium trays for Lara 22 Usable space Tray size mm n 190 x 15 x 387 n 190 x 22 x 387 n 19...

Page 114: ...9 Label printer USB connection kit n USB connection cable n 1 roll of 2100 labels n 1 wax resin ribbon n activation code instructions 19721123 QR code Bar code reader for labels 19721132 Picture Part...

Page 115: ...2 bacteriological filters n 2 dust filters X050328X Refer to each single component above 250 helix strips T800205X Before stocks are exhausted ACTIVATION CODES Activation code Description Part number...

Page 116: ...r Completeness 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...

Page 117: ...ou shown the head of the clinic practice the 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 a...

Page 118: ...W H 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 623...

Page 119: ...Srl 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...

Page 120: ...0 Lara Instructions for Use RIL 1 W H Med ENG Rev06 14 04 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...

Page 121: ...on forms Lara Instructions for Use RIL 1 W H Med ENG Rev06 14 04 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 Ye...

Page 122: ...W H Sterilization Srl via Bolgara 2 Brusaporto BG Italy med wh com 39 035 66 63 000 RIL 1 W H Med Instructions for Use ENG Rev06 14 04 2022 Subject to changes...