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RIN-210-17 RIN-210-22

Instructions for Use

RIN-210 Med - ENG - Rev00

Содержание lyla RIN-210-17

Страница 1: ...RIN 210 17 RIN 210 22 Instructions for Use RIN 210 Med ENG Rev00...

Страница 2: ......

Страница 3: ...r management optional 31 Traceability options optional 32 Managing printers 33 Printer selection optional 33 Label printer selection optional 33 Label printer usage optional 34 Label content descripti...

Страница 4: ...s 75 Errors 75 Troubleshooting 80 Emergency door opening 86 Technical data 89 Sterilization cycles 89 Sterilization cycle phases 94 Technical data 96 Recommendations for validation 98 Diagrams 99 Wate...

Страница 5: ...described in the module D1 AnnexIII 2012 19 EU Waste Electrical and ElectronicEquipment WEEE EN 13060 Small steam sterilizers IEC 61010 1 Safety requirements for electrical equipment for measurement c...

Страница 6: ...uld 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 s...

Страница 7: ...al 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 decomm...

Страница 8: ...nd equipment which are likely to come into contact with blood or bodily fluids e g implements used by beauty therapists tattooists body piercers and hairdressers The devices are intended for professio...

Страница 9: ...quids over the sterilizer risk of electrical short circuits n Switch off the sterilizer and unplug the mains cable before inspecting carrying out maintenance or servicing the sterilizer n Ensure that...

Страница 10: ...a list of security information is mentioned in the MDS2 document which is available on request Responsibility USER RESPONSIBILITY n The user is responsible for the proper installation the correct use...

Страница 11: ...duct description 14 Installing the sterilizer 18 Operating the sterilizer 20 User interface menu 21 Sterilizer setup 27 User authentication optional 28 USB pen drive 29 Standby mode 29 Unpacking UNPAC...

Страница 12: ...ge 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...

Страница 13: ...ded n Water container to capture waste water during manual tank draining volume larger than 5 l 1 3 gal See Accessories spare parts consumables on page 101 for a full list of optional accessories Hand...

Страница 14: ...UCTURE Part Description A Chamber door B Tank C Water level sensor D Water tak cover E Tank filling cover cap F Water tank cover G Internal tank cover H Tank internal filters with metal cartridges I T...

Страница 15: ...Rev00 17 06 2020 2020 W H Sterilization Srl 15 COMPONENTS BEHIND THE SERVICE DOOR Part Description A Bacteriological filter B Mains switch C Identification label D Used water drain port grey E Clean w...

Страница 16: ...7 06 2020 2020 W H Sterilization Srl REAR VIEW Part Description A USBport optional B Air gap cover C Test connection D Pressure safety valve cover E Used water drain optional F Water supply inlet opti...

Страница 17: ...020 W H Sterilization Srl 17 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...

Страница 18: ...uous pay attention to the surrounding materials steam can damage them The sterilizer must operate in absence of explosive atmospheres The sterilizer must operate in a well ventilated room indoor far f...

Страница 19: ...ith the relevant system WI FI CONNECTION OPTIONAL 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 Note fo...

Страница 20: ...hed ON 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 29 3 Tap The homepage appears with...

Страница 21: ...rmat the USBpen 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...

Страница 22: ...storage Only with a network connection set Opens the page to manage the remote storage Settings Only with a network connection set Sets the parameters of the network location Icon Label Function Save...

Страница 23: ...printing of the labels ACCESSORIES MENU FUNCTIONS Icon Label Function USBPen Drive Opens the formatting page of the USBpen drive Format Formats the USBpen drive Icon Label Function Label Printer Opti...

Страница 24: ...ization Srl Getting started Icon Label Function Door Gasket Shows the status of the door gasket for replacement and resets its counter to zero 4000 cycle service Shows the number of cycles performed a...

Страница 25: ...ing making 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...

Страница 26: ...ates that the option is active not active Indicates that the option is enabled disabled Indicates that the user is using the administrator credentials Gives information about the function displayed Co...

Страница 27: ...irm and go back to the previous page SET THE STERILIZER NAME To change the sterilizer name that appears in the cycle reports 1 On the homepage tap 2 Tap the text box a keyboard appears 3 Enter the new...

Страница 28: ...n tap to confirm all entry fields are disabled 5 If your network does not support dynamic IP addresses ask your IT manager enable the options Static both in IP Configuration and in the DNS Configurati...

Страница 29: ...reports The USB pen drive can be inserted equally into the front or rear port optional Notice Periodically remove the USB pen drive to save the cycle data on a computer or on another safe support FORM...

Страница 30: ...s for Use RIN 210 Med ENG Rev00 17 06 2020 2020 W H Sterilization Srl Getting started CHANGING STANDBY MODE DELAY TIME 1 On the homepage tap 2 Tap or to change the delay 3 Tap to confirm and go back t...

Страница 31: ...s 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 adminis...

Страница 32: ...ILABILITY 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 men...

Страница 33: ...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 activati...

Страница 34: ...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 can be set This value is us...

Страница 35: ...release B Traceability code alphanumerical and bar code Released Depending on the traceability settings this field may contain one of the following elements n the user who released the cycle n the use...

Страница 36: ...FORMED ON THE STERILIZER Test Purpose Reference Bowie and Dick test Validate the sterilizer performance for textile load sterilization See Bowie and Dick test below Helixtest Validate the sterilizer p...

Страница 37: ...on chamber except the lowest one 2 Place the Bowie and Dick test pack in the center of a tray in the lowest rack position and close the chamber door 3 On the homepage tap Helix B D test 4 To set the d...

Страница 38: ...RESULT Indicator What happened Test passed What to do next The entire surface of the indicator sheet has changed colour Yes Certain ares of the indicator sheet have not changed colour since there was...

Страница 39: ...pen on one side and closed with a capsule containing a chemical indicator strip on the other side The colour assumed by this indicator strip at the end of the sterilization cycle gives the result of t...

Страница 40: ...er your credentials if required 10 Open the chamber door extract the tray using the tray holder and take the tube CAUTION Risk of burns The test pack is very hot at the end of the cycle Wear appropria...

Страница 41: ...ice If a drainage period of the S Unwrapped 134 cycle is still operating wait the drainage to be finished and the sterilizer to be both cold and dry Otherwise a false negative outcome could occur PURP...

Страница 42: ...Vacuum 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 in...

Страница 43: ...ed by chemicals PACKAGING In order to preserve sterility rotating instruments should be wrapped bagged prior to sterilization Follow the manufacturer s packing instructions when using sterilization pa...

Страница 44: ...out putting them on trays if size allows to enhance drying When sterilizing double decker cassettes place them in the lowest rack position as there is more space height wise Pouched items On trays all...

Страница 45: ...the center of the end edge 1 and slide it outwards 2 FILLING THE CLEAN WATER TANK 1 Switch the sterilizer ON and remove the tank filling cover cap 2 Fill the clean water tank with distilled or deminer...

Страница 46: ...B option is available for the B Universal 134 and B Prion 134 cycles only WARNING For your safety and the safety of your patients never exceed the maximum load weight limits as this could impair the s...

Страница 47: ...9 If required enter your credentials and confirm the release of the load if needed SET THE STERILIZATION CYCLE START You may schedule the start of the sterilization cycles at a certain date and time...

Страница 48: ...cle see Sterilization cycles on page 89 4 Tap to confirm and go back to the previous page If Remember next time is selected this becomes the new fixed value VIEW THE CYCLE PARAMETERS You can check the...

Страница 49: ...d 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 before the DRY phase A cycle can be manually aborted at a...

Страница 50: ...t 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 ca...

Страница 51: ...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 dri...

Страница 52: ...d 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 optional below TEST THE DATA STORAGE OPT...

Страница 53: ...le 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 Cycl...

Страница 54: ...IN 210 Med ENG Rev00 17 06 2020 2020 W H Sterilization Srl Sterilization cycles Data Description Cycle time Cycle time Date below Cycle end date and time Cycle completed Cycle outcome Trk Tracking cod...

Страница 55: ...lx 15 lx to 1500 lx 15 lx Before making any operation ward off unauthorized personnel from the working area CAUTION Before accessing the chamber and the connected parts be sure that the sterilizer is...

Страница 56: ...executed since the last replacement When the number of cycles is close to the maximum a pre alert about the concerned consumable is displayed Please check that you have the requested spare part avail...

Страница 57: ...Clean the seal seat and the chamber face side with a damp lint free cloth moistened with clean water Notice Do not use abrasive products cutting tools or sharp objects If you use a detergent solution...

Страница 58: ...n not 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 s...

Страница 59: ...2020 W H Sterilization Srl 59 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...

Страница 60: ...ev00 17 06 2020 2020 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 fil...

Страница 61: ...erilization Srl 61 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 m...

Страница 62: ...ER 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 56 Proceed as follows 1...

Страница 63: ...e 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 56 Proceed as follows 1 Open the...

Страница 64: ...e the handle back into its original position 6 Close the chamber door 800 cycle or biannual maintenance SEQUENCE OF PROCEDURES TO CLEAN THE WATER TANKS To clean the water tanks proceed as follows 1 Pr...

Страница 65: ...ows 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 73 3 To drain the detergent solution during the su...

Страница 66: ...20 2020 W H Sterilization Srl 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 deterge...

Страница 67: ...eed 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...

Страница 68: ...YLA Instructions for Use RIN 210 Med ENG Rev00 17 06 2020 2020 W H Sterilization Srl 5 Remove the internal filters 6 Clean the metal cartridges of the internal filters with tap water 7 Reposition the...

Страница 69: ...Maintenance LYLA Instructions for Use RIN 210 Med ENG Rev00 17 06 2020 2020 W H Sterilization Srl 69 8 Reposition the internal tank cover and then the water tank cover 9 Detach the drain tube...

Страница 70: ...umable before the maintenance due date you have to reset the cycle counter See Replace the consumable before the maintenance due date on page 56 Proceed as follows 1 Fully open the chamber door 2 Remo...

Страница 71: ...n 6 Press left and right and then the entire seal circumference to ensure its perfect placement Notice A steam discharge can damage the sterilizer plastic parts Ensure the seal does not stick out 7 Wi...

Страница 72: ...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 EL...

Страница 73: ...lizer for at least seven days you have to drain the tanks 1 Open the sterilizer service door 2 Put a container below the sterilizer 5 l 1 3 gal minimum and place the end of the drain tube in it 3 To d...

Страница 74: ...de 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...

Страница 75: ...cription Actions 0xx Load cannot be considered sterile See End of a sterilization cycle on page 49 Repeat the cycle If the problem persists call service Check if the mains switch or network circuit br...

Страница 76: ...nd 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...

Страница 77: ...here are hurdles on the door locking area chamber rack loads objects Repeat the cycle If the problem persists call service Check the door gasket wrong placed Check if the door can move freely without...

Страница 78: ...on page 55 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 c...

Страница 79: ...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...

Страница 80: ...ng 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 steril...

Страница 81: ...ures 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 dow...

Страница 82: ...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 fol...

Страница 83: ...he 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 thermo...

Страница 84: ...m See Load maintenance and preparation on page 43 Scale deposits on the chamber Clean the chamber and use water of good quality See Water quality on page 100 Instruments are turning brown or black Inc...

Страница 85: ...e 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...

Страница 86: ...to serious 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 su...

Страница 87: ...20 W H Sterilization Srl 87 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 ser...

Страница 88: ...W 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 open...

Страница 89: ...aximum 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 o...

Страница 90: ...cs S Prion 134 Features an extended sterilization time if this is required for your load or mandated in your country B available only with Activation Code BUniversal 134 For all your general items lik...

Страница 91: ...ece family n Porous STERILIZATION CYCLE DATA B TYPE CYCLES AVAILABLE ONLY WITH ACTIVATION CODE Sterilization cycles B type cycles available only with Activation Code BUniversal 134 BExtended 134 BUniv...

Страница 92: ...oad Empty Full Typical 2 5 kg LYLA 17 LYLA 22 LYLA 17 LYLA 22 LYLA 17 LYLA 22 S Unwrapped 134 20 21 26 27 23 24 S Wrapped 134 39 30 40 30 46 30 47 30 43 30 44 30 S Gentle 121 61 62 64 66 63 64 S Prion...

Страница 93: ...kg 0 5 kg 0 5 kg BExtended 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 BExtended 134 ECOmode only with AC 0 5 kg 0 5 kg 0 5 kg 0 5 kg 0 5 kg 0 5 kg B...

Страница 94: ...HE Pre 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 P...

Страница 95: ...Srl 95 TYPE S STERILIZATION CYCLE PHASES The S Naked 134 cycle is specifically designed to sterilize unwrapped instruments for immediate use on patients not requiring a complete drying Thus the drying...

Страница 96: ...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 Ma...

Страница 97: ...GENERATOR Pressure safety valve 5 bar 72 51 psi Safety thermostats 230 C 446 F DISTILLED OR DEMINERALIZED WATER Water quality Fulfilling EN 13060 Ann C conductivity 15 S cm Total Dissolved Solids 10 p...

Страница 98: ...chnical data Recommendations for validation TEST VALIDATION POINTS LYLA sterilizers can be validated in accordance to EN17665 1 For further details please refer to the Qualification Validation guide f...

Страница 99: ...on Srl 99 Diagrams CONNECTION DIAGRAMS Data communication Water system Note Rear serial connection Note The water filtration system must be fitted with a backflow preventing device complying to IEC 61...

Страница 100: ...ity at 20 C 15 s 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 mus...

Страница 101: ...28 x312 n 188 x22 x312 F523031X Note rack rotated 90 Standard chamber rack for 3 cassettes containers for LYLA 17 Usable space Cassette size mm n 190 x50 x312 n 190 x50 x312 n 190 x50 x312 Picture Par...

Страница 102: ...l chamber rack for 3 cassettes containers for LYLA 22 Usable space Cassette size mm n 205 x35 x380 n 210 x35 x380 n 205 x35 x380 F523021X Picture Part Part number Optional chamber rack for 4 cassettes...

Страница 103: ...amber rack for 2 cassettes containers for LYLA 22 Usable space Cassette size mm n 190 x70 x380 n 190 x70 x380 F523017X Picture Part Part number Optional chamber rack for 6 aluminium trays for LYLA 17...

Страница 104: ...ce Cassette size mm n 190 x50 x400 n 190 x50 x400 n 190 x50 x400 Picture Part Part number Optional chamber rack for 2 aluminium trays and 3 wider aluminium trays for LYLA 22 Usable space Cassette size...

Страница 105: ...A801503X Label printer LisaSafe label printer only 19721109 LisaSafe Connection Kit n USBconnection cable n 1 roll of 2100 labels n 1 wax resin ribbon n activation code instructions 19721123 Picture...

Страница 106: ...andard aluminium trays CONSUMABLES Picture Part Part number When replace it Bacteriological filter W322400X Every 400 cycles Door gasket F460504X Every 800 cycles Dust filter F364511X Every 400 cycles...

Страница 107: ...pe cycles 19730053 Remote data storage Activates the Remote data storage 19730054 Traceability Activates the User Management and Options menus 19730056 All in One Activates n Bcycles n Traceability n...

Страница 108: ...7 Were all sections of the Instructions for Use of the sterilizer covered and explained during the in service Yes No Workplace suitability 8 Is the allocated countertop for the sterilizer levelled an...

Страница 109: ...ach 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...

Страница 110: ...zation Srl Helix test documentation form INSTRUCTIONS Use this page to create a logbook tracing the effectiveness of the sterilization cycle during the whole lifespan of your sterilizer FORM Date Cycl...

Страница 111: ...A Instructions for Use RIN 210 Med ENG Rev00 17 06 2020 2020 W H Sterilization Srl 111 Date Cycle n Operator Released Signature Chemical indicator Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes...

Страница 112: ...forms 112 LYLA Instructions for Use RIN 210 Med ENG Rev00 17 06 2020 2020 W H Sterilization Srl Date Cycle n Operator Released Signature Chemical indicator Yes No Yes No Yes No Yes No Yes No Yes No Y...

Страница 113: ......

Страница 114: ...Manufacturer W H Sterilization Srl via Bolgara 2 Brusaporto BG Italy www wh com 39 035 66 63 000 RIN 210 Med Instructions for Use ENG Rev00 17 06 2020 Subject to changes...

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