W&H Med lyla RIN-210-17 Instructions For Use Manual
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W&H Med lyla RIN-210-17 Instructions For Use Manual

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Instructions for Use
RIN-210 Med - ENG - Rev00
RIN-210-17 RIN-210-22

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Summary of Contents for W&H Med lyla RIN-210-17

  • Page 1 Instructions for Use RIN-210 Med - ENG - Rev00 RIN-210-17 RIN-210-22...

  • Page 3: Table Of Contents

    Table of contents Conformity Printer selection (optional) Symbols and messages Label printer selection (optional) Introduction Label printer usage (optional) About this manual Label content description Use restrictions Sterilizer tests Safety information Sterilizer performance tests Safety warnings Bowie and Dick test Responsibility Helix test Getting started...
  • Page 4 4000 cycle or five-year maintenance Extraordinary maintenance Disposal Diagnostics Errors Troubleshooting Emergency door opening Technical data Sterilization cycles Sterilization cycle phases Technical data Recommendations for validation Diagrams Water quality Accessories, spare parts, consumables Authorized W&H service partners Documentation forms W&H installation check-list Helix test documentation form LYLA ...

  • Page 5: Conformity

    Conformity Note: LYLA sterilizers can be validated in accordance to EN17665-1. CONFORMITY TO EUROPEAN STANDARDS AND DIRECTIVES STERILIZER featuring sterilization cycles conform with the following Note: Every new sterilizer is delivered with a Declaration of Conformity and a Warranty Card. standards: Standards Description...

  • Page 6: Symbols And Messages

    Symbols and messages SAFETY SYMBOLS USED IN THIS MANUAL WARNING: Indicates a hazardous situation that, if not avoided, could CAUTION: Indicates a hazardous situation that, if not avoided, could result in death or serious injury. result in minor or moderate injury. Related to a sterilizer, these warnings indicate hazardous situations that could result in non-sterile conditions (e.g.

  • Page 7: Introduction

    Introduction CONTENTS OBLIGATIONS WITH REGARD TO THIS MANUAL This section deals with the following subjects: This manual is an integral part of the product and accompanies it for its entire working life. It must be consulted in all situations related About this manual to the life cycle of the product, from its delivery through to Use restrictions...

  • Page 8: Use Restrictions

    Introduction COPYRIGHT NOTICE USER QUALIFICATION Copyright © 2020, W&H Sterilization Srl The users who may operate the sterilizer are the following. All rights reserved in all countries. User Competences All drawings, images and texts contained in this manual are the qualification property of the manufacturer.

  • Page 9: Safety Information

    Safety information CONTENTS ELECTRICAL RISKS This section deals with the following subjects: Do not pour water or any other liquids over the sterilizer (risk of electrical short circuits). Safety warnings Switch off the sterilizer and unplug the mains Responsibility cable before inspecting, carrying out maintenance or servicing the sterilizer.

  • Page 10: Responsibility

    Safety information TAMPERING Responsibility Do not remove the name plate or labels from the sterilizer. USER RESPONSIBILITY Repairs, maintenance or service must be carried The user is responsible for the proper installation, the correct out by authorized service providers always using use and maintenance of the sterilizer in accordance with these genuine spare parts.

  • Page 11: Getting Started

    Getting started CONTENTS Unpacking This section deals with the following subjects: Unpacking UNPACK THE STERILIZER Handling CAUTION! Heavy product. The sterilizer must be removed Product description from the box and transported by two authorized technicians. Installing the sterilizer Weight: Operating the sterilizer LYLA 17: 41.5 kg (91.5 lbs) User interface menu LYLA 22: 43.5 kg (95.9 lbs)
  • Page 12 Getting started WARNINGS Notice: Check the external condition of the box and the sterilizer. In 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 of the product is environmentally friendly and can be disposed of by industrial recycling companies.

  • Page 13: Handling

    Getting started ITEMS NOT PROVIDED WITH THE STERILIZER The following items are not provided: 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.

  • Page 14: Product Description

    Getting started Product description FRONT VIEW AND UPPER INTERNAL STRUCTURE Part Description Chamber door Tank Water level sensor Water tak cover Tank filling cover-cap Water tank cover Internal tank cover Tank internal filters with metal cartridges Touch screen Service door Sterilization chamber Dust filter Reset button of the thermostat switch...
  • Page 15 Getting started COMPONENTS BEHIND THE SERVICE DOOR Part Description Bacteriological filter Mains switch Identification label Used water drain port (grey) Clean water drain port (blue) Drain tube release button USB port LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...
  • Page 16 Getting started REAR VIEW Part Description USB port (optional) Air gap cover Test connection Pressure safety valve cover Used water drain (optional) Water supply inlet (optional) Condenser grid Mains cable guide Mains cable plug socket LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...
  • Page 17 Getting started CHAMBER ACCESSORIES Part Description Tray Chamber rack: In the normal position, it can host 5 trays horizontally or 3 cassettes/containers vertically. In a 90° degrees rotated position, it can host 3 trays or 3 cassettes/containers horizontally. LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...

  • Page 18: Installing The Sterilizer

    Getting started Clearance requirements to ensure proper air circulation: Installing the sterilizer LOCATION REQUIREMENTS Notice: Do not place the sterilizer so that it is difficult to operate the controls behind the service door. Do not place the sterilizer so that it is difficult to disconnect the power supply plug.
  • Page 19 Getting started The installation of the sterilizer shall be performed by two INSTALLING THE STERILIZER authorized technicians using PPE (Personal Protective Equipment) WARNING! In case of sterilizer malfunctions immediately according to applicable standards. unplug the sterilizer and call for service. Do not attempt to The electrical power supply of the sterilizer must fulfill all applicable repair the sterilizer by yourself.

  • Page 20: Operating The Sterilizer

    Getting started Operating the sterilizer POWER THE STERILIZER ON/OFF Press the power switch behind the service door: once switched ON, the visual indicator on the power switch will turn green. After a quick autotest the sterilizer automatically turns in standby mode. See "Standby mode" on page  29. .

  • Page 21: User Interface Menu

    Getting started User interface menu SETTINGS MENU FUNCTIONS Icon Function Label MAIN MENU FUNCTIONS Opens the pages to set the device. Device Icon Function Label Menu Opens the menu. Language Sets the language. Settings Sets the device. Date & Time Sets time and date values and format.
  • Page 22 Getting started Icon Function Icon Function Label Label Connectivity Opens the pages to manage the network connection. Save all Only with a network connection set. Copies all the files in the specified location in the network. Manages the Ethernet network. Ethernet Test Only with a network connection set.
  • Page 23 Getting started Icon Function Icon Function Label Label Optional, activated with an activation code. Selects the Delete User Administrator only. Deletes a user. Label label printer and sets the printout layout. Printer Selects a printer connected to the sterilizer. Reset user PIN Administrator only.
  • Page 24 Getting started Icon Function Label Door Shows the status of the door gasket for replacement and Gasket resets its counter to zero. Shows the number of cycles performed and left before the 4000 cycle necessary maintenance. service Updates the software. Software Update LYLA ...
  • Page 25 Getting started COMMON COMMANDS AND ICONS Icon Function Icon Function Icon Function Refreshes the page. Indicates that an error occurs. Enters/exits the standby mode. Indicates the value that may be Indicates that the option checked is changed and appears by clicking on working properly.
  • Page 26 Getting started Icon Function Icon Function Indicates that the option is OFF and Shows a sterilization summary. allows to set it ON by touching it. Indicates that the option is active/not active. Indicates that the option is enabled/disabled. Indicates that the user is using the administrator credentials.

  • Page 27: Sterilizer Setup

    Getting started Sterilizer setup SET THE STERILIZER NAME To change the sterilizer name that appears in the cycle reports: SET THE LANGUAGE On the homepage tap > > > On the homepage tap > > > Tap the text box:  a keyboard appears. Tap the language you prefer.

  • Page 28: User Authentication (Optional)

    Getting started On the homepage tap > > User authentication (optional) If the connection is through the Ethernet cable, tap : the TCP/IP screen appears. FUNCTION AVAILABILITY To access the user management functions the User Management If the connection is through Wi-Fi key, tap : after a while, the activation code must be entered.

  • Page 29: Usb Pen Drive

    Getting started On the homepage tap > > FORMAT THE USB PEN DRIVE On the homepage tap > > Tap your user name. Insert the USB pen drive in one of the two USB ports. Enter your current PIN and tap to confirm.
  • Page 30 Getting started CHANGING STANDBY MODE DELAY TIME On the homepage tap > > > to change the delay. to confirm and go back to the previous page. LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...

  • Page 31: Administrator

    Administrator CONTENTS ADD A USER This section deals with the following subjects: On the homepage tap > > User management (optional) Tap your user name. Traceability options (optional) Enter the PIN and tap to confirm. User management (optional) Tap the text box:  a keyboard appears. Enter the new user name and tap to confirm.

  • Page 32: Traceability Options (Optional)

    Administrator DELETE A USER Traceability options (optional) On the homepage tap > > FUNCTION AVAILABILITY Tap your user name. To access the user management functions the User Management Enter the PIN and tap to confirm. 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 enabled and...

  • Page 33: Managing Printers

    Managing printers CONTENTS Label printer selection (optional) This section deals with the following subjects: FUNCTION AVAILABILITY Printer selection (optional) The first time you access the Label Printer ( ) menu, you will be Label printer selection (optional) requested to enter an activaction code. To require the activation Label printer usage (optional) code, please refer to the Activation code instructions provided with Label content description...

  • Page 34: Label Printer Usage (Optional)

    Managing printers Label printer usage (optional) SET THE AUTOMATIC LABEL PRINTING On the homepage tap > > CAUTION! For your safety and the safety of your patients use a storage time compliant with the recommendations of the Activate Automatic printing. manufacturers of the containters/packaging used, and with to set the maximum storage time and the number applicable norms and rules.

  • Page 35: Label Content Description

    Managing printers Label content description STRUCTURE Part Description Sterilizer model Serial number Software release Traceability code (alphanumerical and bar code) Released Depending on the traceability settings, this field may contain one of the following elements: the user who released the cycle the user who started the cycle the sterilizer ID Cycle...

  • Page 36: Sterilizer Tests

    Sterilizer tests CONTENTS This section deals with the following subjects: Sterilizer performance tests Bowie and Dick test Helix test Vacuum test Sterilizer performance tests TESTS THAT CAN BE PERFORMED ON THE STERILIZER Test Purpose Reference Bowie and Dick test Validate the sterilizer performance for textile load sterilization. See "Bowie and Dick test"...
  • Page 37 Sterilizer tests PURPOSE OF THE TEST The test is used to validate the sterilizer performance 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 this indicator sheet at the end of the sterilization cycle gives the result of the test.
  • Page 38 Sterilizer tests INTERPRET THE TEST RESULT Test Indicator What happened What to do next passed The entire surface of the indicator sheet has changed colour. Certain ares of the indicator sheet have not changed colour since there was an air Repeat the test.

  • Page 39: Helix Test

    Sterilizer tests Helix test CAUTION! Follow local/national guidelines on the frequency of testing. PURPOSE OF THE TEST The test is used to validate the sterilizer performance for hollow items. DESCRIPTION It consists of a 1.5 m long tube open on one side and closed with a capsule containing a chemical indicator strip on the other side. The colour assumed by this indicator strip at the end of the sterilization cycle gives the result of the test.
  • Page 40 Sterilizer tests Place the tube with the capsule in the center of a tray in the lowest rack position and close the chamber door. On the homepage tap Helix-B&D test. To set the duration of the Plateau/Sterilization phase and other settings, tap and enter your credentials if required: the chamber door locks.

  • Page 41: Vacuum Test

    Sterilizer tests WHAT TO DO NEXT Compile the Helix test documentation form to trace the effectiveness of the sterilization cycle during the whole lifespan of your sterilizer. See "Helix test documentation form" on page  110. Vacuum test CAUTION! Follow local/national guidelines on the frequency of testing. Notice: 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.
  • Page 42 Sterilizer tests CARRY OUT THE TEST Empty the sterilizer chamber to ensure no load is present. Close the chamber door and ensure the sterilizer chamber is completely dry and cold to avoid any false negative outcome. On the homepage tap Vacuum test. and enter your credentials if required: the chamber door locks.

  • Page 43: Sterilization Cycles

    Sterilization cycles CONTENTS PACKAGING This section deals with the following subjects: In order to preserve sterility, rotating instruments should be wrapped/bagged prior to sterilization. Follow the manufacturer’s Load maintenance and preparation packing instructions when using sterilization packaging. Prepare the sterilizer Sterilization cycle description CLEANING THE INSTRUMENTS Sterilization cycle management...
  • Page 44 Sterilization cycles Wrap items with porous wrapping materials to facilitate steam Load type Placement penetration and drying (e.g. sterilization bags for autoclaves). Empty containers or non- Upside down to prevent accumulation of water Always use the chamber rack to allow adequate steam perforated trays circulation.

  • Page 45: Prepare The Sterilizer

    Sterilization cycles Prepare the sterilizer FILLING THE CLEAN WATER TANK Switch the sterilizer ON and remove the tank filling cover-cap. Fill the clean water tank with distilled or demineralized water WARNINGS until the sterilizer makes a sound. See "Technical data" on Notice: Use only distilled or demineralized water (see "Feed water page ...

  • Page 46: Sterilization Cycle Description

    Sterilization cycles To enjoy the full benefit of short cycle times when only one Sterilization cycle management tray is used, always place the load on the upper tray of the chamber rack and remove all other trays from the chamber. B-TYPE CYCLES ACTIVATION Note: If you have entered the All in One activation code in Special Codes Sterilization cycle description...
  • Page 47 Sterilization cycles Select the ECO mode based on the weight of the load to be On the homepage tap the cycle. sterilized. To change the start time, tap Start cycle at. and enter your credentials if required: the door locks. If Tap the time or the date: a settings page opens.
  • Page 48 Sterilization cycles SET THE DRYING TIME STERILIZATION CYCLE PAGE The drying time of the AUTO DRY and ECO DRY plus modes is Following are the information displayed while a cycle is running: automatically adjusted to the total amount of load and cannot be modified (see "Sterilization cycle description"...
  • Page 49 Sterilization cycles to abort the stop command. The cycle continues END OF A STERILIZATION CYCLE programmed. When a cycle is successfully finished, the "Cycle completed" message appears on the screen. To end the cycle: to abort the cycle: the sterilizer starts a reset phase. to view the cycle summary or tap to view the cycle Notice: Do not switch off the sterilizer during the reset phase: it...

  • Page 50: Unloading

    Sterilization cycles MESSAGES OF A STOPPED STERILIZATION CYCLE WHAT HAPPENS WITH UNSAVED CYCLES Following are the messages: 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 Load not sterile: Do not use items on patients! in memory, the unsaved cycles will be copied in a working USB pen Drying interrupted: The load might be wet.
  • Page 51 Sterilization cycles PRINT LABELS FOR A SPECIFIC CYCLE SET THE REMOTE FOLDER FOR SAVING THE REPORTS (OPTIONAL) Function availability Note: Function available only with the Label printer activation code. The first time you access the Remote data storage ( ) menu, you On the homepage tap >...
  • Page 52 Sterilization cycles Procedure TEST THE DATA STORAGE (OPTIONAL) To activate the remote storage and set the necessary parameters Note: The test function is available only if the remote data storage is do the following: enabled. See "Set the remote folder for saving the reports (optional)" on the previous page.
  • Page 53 Sterilization cycles CYCLE REPORT STRUCTURE Data Description Following the structure of a cycle report: Sterilizer model Sterilizer serial number Software rev. Software revision number Sterilizer Name Surgery – practice – doctor name Cycle Name of the executed cycle Number Cycle counter Sterilizat.
  • Page 54 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 LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...

  • Page 55: Maintenance

    Maintenance CAUTION! Before accessing the chamber and the connected CONTENTS parts, be sure that the sterilizer is cold. This section deals with the following subjects: Notice: Follow the instructions in this chapter when carrying out any Warnings for maintenance operations maintenance on the sterilizer.
  • Page 56 Maintenance If you can not replace the consumable immediately, the sterilizer Frequency Cycles Operation will operate anyway but the message will appear again some cycles later. Replace the bacteriological filter. See "400-cycle Yearly maintenance" on page  62. When you have replaced the consumable tap to confirm: the Replace the dust ...

  • Page 57: Monthly Or 50-Cycle Maintenance

    Maintenance Monthly or 50-cycle maintenance CLEANING THE DOOR GASKET AND THE CHAMBER FACE SIDE Proceed as follows: Clean the seal seat and the chamber face side with a damp, lint-free cloth moistened with clean water. Notice: Do not use abrasive products, cutting tools or sharp objects. If you use a detergent solution, be careful not to get in contact with the plastic body of the front cover.
  • Page 58 Maintenance CLEANING THE CHAMBER AND THE CHAMBER ACCESSORIES Proceed as follows: Remove the trays, the chamber rack and the steam diffuser plate. Clean the chamber with a damp sponge and a mild detergent solution paying attention not to bend or damage the temperature probe inside the sterilizer chamber.
  • Page 59 Maintenance CLEANING THE CHAMBER FILTER Proceed as follows: Allow the sterilization chamber to cool down. Empty the sterilizer chamber by removing the trays and the rack. Turn the filter cap at the back of the chamber (bottom/center) counter-clockwise. LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...
  • Page 60 Maintenance Remove the filter cap and the cartridge filter. Rinse the cartridge filter with tap water. Insert the cartridge filter in the filter cap. Insert the filter cap with the cartridge filter in its original position. LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...
  • Page 61 Maintenance Lock the filter cap by turning it clockwise. CLEANING THE EXTERNAL SURFACES OF THE STERILIZER Proceed as follows: Clean all external sterilizer covers with a slightly damp cloth moistened with water. Notice: Never use disinfectants, detergents or abrasive products. LYLA ...

  • Page 62: 400-Cycle Maintenance

    Maintenance 400-cycle maintenance REPLACING THE BACTERIOLOGICAL FILTER 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: Open the service door.
  • Page 63 Maintenance REPLACING THE DUST FILTER 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: Open the chamber door. Pull out the dust filter handle from underneath the sterilizer.

  • Page 64: 800-Cycle Or Biannual Maintenance

    Maintenance Insert the new filter into the handle. Slide the handle back into its original position. 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: "Prepare the sterilizer for cleaning the water tanks"...
  • Page 65 Maintenance PREPARE THE STERILIZER FOR CLEANING THE WATER TANKS Proceed as follows: Switch OFF the sterilizer and disconnect the mains cable. Completely drain both water tanks (see "Draining the used and clean water tank" on page  73). To drain the detergent solution during the subsequent cleaning, leave the drain tube attached to the drain port of the tank you want to clean. ACCESS TO THE WATER TANKS Proceed as follows: Lift the water tank cover.
  • Page 66 Maintenance Remove the internal tank cover. 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. LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...
  • Page 67 Maintenance CLEAN THE WATER TANKS Notice: Do not touch the water level sensors. If misplaced or misaligned from their original position, the operation of the sterilizer could be impaired. Proceed as follows: Clean the internal tank surfaces with a soft sponge and a mild detergent solution. Notice: Never use disinfectants, strong detergents or abrasive products.
  • Page 68 Maintenance Remove the internal filters. Clean the metal cartridges of the internal filters with tap water. Reposition the internal filters. LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...
  • Page 69 Maintenance Reposition the internal tank cover and then the water tank cover. Detach the drain tube. LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...

  • Page 70: 800-Cycle Maintenance

    Maintenance 800-cycle maintenance REPLACING THE DOOR GASKET 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: Fully open the chamber door.
  • Page 71 Maintenance Insert the new seal and press first up and down. 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. Wipe any residual water and run a Vacuum and Helix test to check for perfect tightness of the seal.

  • Page 72: 4000 Cycle Or Five-Year Maintenance

    Maintenance 4000 cycle or five-year maintenance Element Replace Clean Check Internal parts, with particular care for the condenser fins and the main board GENERAL CHECK AND SERVICE REQUIRED Notice: Regular service is imperative to ensure continuous and Steam diffuser plate effective operation of the sterilizer.

  • Page 73: Extraordinary Maintenance

    Maintenance Extraordinary maintenance DRAINING THE USED AND CLEAN WATER TANK If you left accidentally the tanks full for more than seven days or if you plan not to use the sterilizer for at least seven days, you have to drain the tanks.

  • Page 74: Disposal

    Maintenance Disposal DISPOSAL RESPONSIBILITY Separate the various components according to the materials they are made of. Drop the sterilizer with a company that specializes on the recycling of related products. Do not abandon the sterilizer in unsecured places. Always refer to current/applicable laws and rules in the country of use. The same instructions apply to disposal of all used consumable parts.

  • Page 75: Diagnostics

    Diagnostics CONTENTS This section deals with the following subjects: Errors Troubleshooting Emergency door opening Errors CHECKS AND ACTIONS Notice: For any error not listed in this table, call technical service. Code Description Actions Load cannot be considered sterile. See "End of a sterilization cycle" on page  49 Repeat the cycle.
  • Page 76 Diagnostics Code Description Actions Wait before opening the chamber door. Allow the sterilization chamber to cool down. See error "13x to 16x" Repeat the cycle. below. If the problem persists, call service. 13x to 16x Check water level in the clean water tank. Reset the safety thermostat.. Repeat the cycle.
  • Page 77 Diagnostics Code Description Actions Check the door gasket. Clean or replace it if necessary. Repeat the cycle. If the problem persists, call service. Clean the chamber face side. Clean the chamber filter. Check if chamber filter is properly locked in the cap. Check the load does not exceed the MAXIMUM WEIGHT LIMITS.
  • Page 78 Diagnostics Message/Alert Description Action Non-conform water The clean water quality is bad (conductivity You may run a cycle but the water must be replaced soon, otherwise the unit will between 15 and 50 μS/cm). automatically lock-out to prevent damage. Unacceptable water The clean water quality is very bad (conductivity Running a cycle is inhibited to prevent damage.
  • Page 79 Diagnostics Message/Alert Description Action Door Gasket replacement is due. These messages advise that one consumable Replace the consumable and tap to reset the counter (See "Maintenance" on must be replaced. page  55). Have you replaced the door gasket? If you don't replace the consumable, press In this case, you may still use the sterilizer but the message will appear again after Bact.

  • Page 80: Troubleshooting

    Diagnostics The following page appears: Troubleshooting Part Description MANAGING ERRORS Current sterilization If during a sterilization cycle an error occurs do the following: cycle Wait until the end of the reset phase. Error number, See "Errors" on CAUTION! Do not switch off the sterilizer during the reset page ...
  • Page 81 Diagnostics RESET THE SAFETY THERMOSTAT The sterilizer 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: Switch the sterilizer OFF and remove the mains cable.
  • Page 82 Diagnostics Close the chamber door. Connect the mains cable and place the sterilizer back into its original position. Switch the sterilizer ON. 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. LYLA ...
  • Page 83 Diagnostics TROUBLESHOOTING TABLE Note: If your problem is not resolved, call your authorized service provider. Notice: Before sending the sterilizer for technical service, remove the mains cable, empty both water tanks and use the original or appropriate packaging. Problem Possible cause Solutions The sterilizer remains switched The mains switch or network circuit breaker is OFF.
  • Page 84 Diagnostics Problem Possible cause Solutions Corrosion or spots on Tap water on instruments when placed in the Ensure that instruments are dry before they are placed in the sterilizer. instruments. sterilizer. Use of water of poor quality or water containing Drain both water tanks.
  • Page 85 Diagnostics Problem Possible cause Solutions When the sterilizer is connected Water fill system not connected. Connect the water fill system to the sterilizer. See "Water quality" on page  100. to an automated water supply When the water fill system attempted to fill the Since water tank filling is attempted only once in-between cycle execution, this event system: there is no clean water in tank, water was temporarily unavailable.

  • Page 86: Emergency Door Opening

    Diagnostics Emergency door opening WARNING ABOUT OPENING THE DOOR IN EMERGENCY WARNING! High pressure. Risk of explosion, jet of hot steam, sudden opening of the door. Carry out the following procedure only if necessary and only when NO RESIDUAL PRESSURE IS IN THE CHAMBER. Any attempt to open the door while the unit is still hot or under pressure could expose the operator and the surrounding personnel to serious risk.
  • Page 87 Diagnostics OPEN THE DOOR IN EMERGENCY Unplug the sterilizer and wait at least three hours. Take the emergency door opening tool included in the sterilizer box. Firmly open the service door. Unscrew the bacteriological filter by hand (counter-clockwise). LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...
  • Page 88 Diagnostics Plug two batteries into the connectors. Holding the service door pulled, plug the plastic connector into the socket behind the bacteriological filter. As soon as the door opens, unplug the plastic connector to prevent system overload and consequent damage. LYLA ...

  • Page 89: Technical Data

    Technical data CONTENTS This section deals with the following subjects: Sterilization cycles Sterilization cycle phases Technical data Recommendations for validation Diagrams Water quality Accessories, spare parts, consumables Authorized W&H service partners Sterilization cycles WARNINGS For your safety and for the safety of your patients: WARNING! Never process objects different from those specified in the cycle program table and never exceed the maximum load weight limits specified in it as this could impair the sterilization process.
  • Page 90 Technical data STANDARD STERILIZATION CYCLES AVAILABLE There are seven sterilization cycles available, all of them complying with the European Standard EN13060: four S-type cycles three B-type cycles (optional, activated with B cycles activation code. See "B-type cycles activation" on page  46) Cycle type Cycle name Purpose...
  • Page 91 Technical data Sterilization cycles (S-type cycles) S Prion 134 S Unwrapped 134 S Wrapped 134 S Gentle 121 Minimum duration of the drying phase (set by the user) Load type Unwrapped items: Wrapped items: Solid, simple hollow Solid Simple hollow items items Hinges device Hinges device...
  • Page 92 Technical data TOTAL CYCLE DURATION The total cycle time includes the drying time and may vary according to different elements, such as the following: type of load (solid or porous) load weight other factors Values and cycle names could be different depending on country requirements. Load Empty Full...
  • Page 93 Technical data MAXIMUM LOAD FOR INSTRUMENTS Note: The load given includes the trays, the containers and everything is put into the chamber, with the sole exclusion of the tray rack. Instruments Bagged Unwrapped Porous LYLA 17 LYLA 22 LYLA 17 LYLA 22 LYLA 17 LYLA 22...

  • Page 94: Sterilization Cycle Phases

    Technical data Sterilization cycle phases COMMON LEGEND OF THE STERILIZATION CYCLE PHASES Following is the description of the sterilization phases. Code Description Pre-heating of the sterilizer. This phase is not considered a part of the cycle. Heating phase (heat the chamber and the load) PV1 - PV2 Vacuum pulse (removal of air from the sterilizer chamber/load) PP1 - PP2...
  • Page 95 Technical data 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 phase of this cycle is short and not assisted by vacuum, making this cycle the fastest available. LYLA ...

  • Page 96: Technical Data

    Technical data Technical data Storage temperature / rel. From -20 °C to +60 °C (from -4 °F to +140 °F )/0–90 % (with empty humidity tanks) Max altitude 3000 m asl WATER SUPPLY SYSTEM Min. atmospheric pressure 0.6 bar (8.7 psi) Temperature max.
  • Page 97 Technical data trays, see "Accessories, spare parts, consumables" on page  101. STEAM 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: < 15μS/cm, Total Dissolved Solids: <...

  • Page 98: Recommendations For Validation

    Technical 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 for sterilization cycles of the manufacturer. Part Description Hottest points Coldest points LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...

  • Page 99: Diagrams

    Technical data 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  96. Note (**): Rear serial connection.

  • Page 100: Water Quality

    Technical data Water quality Contaminants/minerals/qualities Value/Specification Appearance colorless, clean, free from sediment FEED WATER SPECIFICATIONS (EN 13060) Hardness < 0.02 mmol/l Notice: Do not use rust inhibitor or any other agents in the clean No chemicals or additives must be added to the Chemical additives water tank.

  • Page 101: Accessories, Spare Parts, Consumables

    Technical data Accessories, spare parts, consumables Part Picture Part number Standard chamber rack for 5 F523032X LIST OF ACCESSORIES AND SPARE PARTS aluminium trays for LYLA 22 Part Usable space - Cassette size Picture Part number (mm): 188 x 21 x 400 Standard chamber rack for 5 F523031X 188 x 28 x 400...
  • Page 102 Technical data Part Part Picture Part Picture Part number number Optional chamber rack for 3 F523020X Optional chamber rack for 4 F523012X cassettes /containers* for LYLA cassettes/containers* for LYLA Usable space - Cassette size Usable space - Cassette size (mm): (mm): 205 x 35 x 300 190 x 32 x 300...
  • Page 103 Technical data Part Part Picture Part Picture Part number number Optional chamber rack for 2 F523016X Optional chamber rack for 6 F523033X cassettes /containers* for LYLA aluminium trays for LYLA 17 Usable space - Cassette size Usable space - Cassette size (mm): 188 x 19 x 312 (mm):...
  • Page 104 Technical data Part Part Picture Part Picture Part number number Optional chamber rack for 6 F523034X Optional chamber rack for 2 F523035X aluminium trays for LYLA 22 aluminium trays and 3 wider aluminium trays for LYLA 22 Usable space - Cassette size (mm): Usable space - Cassette size 188 x 19 x 400...
  • Page 105 Technical data Part Part Picture Part Picture Part number number Drain tube kit with fittings A812110X QR code / Bar code reader for labels 19721132 Drain tube S230900X Dist - water distiller 19723101 Mains cable U38012XX Multidem C27 - water demineralizer 19723112 (only with AWF kit) USB pen drive...
  • Page 106 Technical data CONSUMABLES Part Picture Part number Part Picture Part When replace it number AWF Kit X051500X Bacteriological filter W322400X Every 400 cycles Door gasket F460504X Every 800 cycles USB Kit X051405X Dust filter F364511X Every 400 cycles 400/800 cycle X050328X Refer to each single consumable kit...

  • Page 107: Authorized W&H Service Partners

    Technical data ACTIVATION CODES Part Activation code Description number B cycles Activates the b-type cycles 19730053 Remote data Activates the Remote data storage 19730054 storage Traceability Activates the User Management and Options 19730056 menus All in One Activates: 19730058 B cycles Traceability Remote data storage Note: use only accessories recommended by W&H.

  • Page 108: Documentation Forms

    Documentation forms CONTENTS Question Answer This section deals with the following subjects: Completeness of the Instructions for Use W&H installation check-list Were all sections of the Instructions for Use of the sterilizer Yes No covered and explained during the in-service? Helix test documentation form Workplace suitability Is the allocated countertop for the sterilizer levelled and flat?
  • Page 109 Documentation forms INSTALLATION INFORMATION Question Answer RIN-210 Serial Number: 17 Have you shown the Head of the clinic/practice the maintenance Yes No program and procedures? Date: 18 Have you shown the Head of the clinic/practice how to use all of Yes No Purchased from: the accessories?

  • Page 110: Helix Test Documentation Form

    Documentation forms 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 LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...
  • Page 111 Documentation forms Date Cycle n. Operator Released Signature Chemical indicator LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...
  • Page 112 Documentation forms Date Cycle n. Operator Released Signature Chemical indicator LYLA  | Instructions for Use |  RIN-210 Med ENG Rev00 |  17/06/2020 |  © 2020 W&H Sterilization Srl...
  • Page 114 Manufacturer RIN-210 Med Instructions for Use W&H Sterilization Srl via Bolgara, 2 Rev00 Brusaporto (BG) 17/06/2020 Italy Subject to changes www.wh.com +39 035 66 63 000...

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