W&H Lara RIS-311 Instructions For Use Manual
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W&H Lara RIS-311 Instructions For Use Manual

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Instructions for Use
RIS-311
RIS-311 - ENG - Rev02

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Summary of Contents for W&H Lara RIS-311

  • Page 1 Instructions for Use RIS-311 RIS-311 - ENG - Rev02...

  • Page 3: Table Of Contents

    Table of contents Conformity Hide/Unhide a cycle Symbols and messages Managing printers Introduction Printer selection (optional) About this manual Label printer selection (optional) Use restrictions Label printer usage (optional) Label content description Safety information Safety warnings Sterilizer tests Responsibility Sterilizer performance tests Getting started Bowie and Dick test Unpacking...
  • Page 4 800-cycle or biannual maintenance 800-cycle maintenance 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 Lara XL ...

  • Page 5: Conformity

    Conformity CONFORMITY TO EUROPEAN REGULATIONS, STANDARDS AND Standards DIRECTIVES Description Directives Sterilizer conforms with the following Regulations, Standards and Directives: Safety requirements for electrical equipment for measurement, IEC 61010-2- control and laboratory use; particular requirements for sterilizers and washer-disinfectors used to treat medical materials. Standards Description Electrical equipment for measurement, control and laboratory use...

  • 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 Storage. Manufacturer. OFF (supply) IEC 60417- 5008. Transportation. IN-position of bistable push Unique Device control IEC 60417-5268. Identification. Medical Device. Only for MDR devices. Health industry bar code in OUT- position of bistable accordance with HIBC Serial Number. push control IEC 60417- Standard.

  • Page 8: Introduction

    Introduction Contact customer service in the event the manual is unavailable. If CONTENTS the device is transferred, always attach the manual for the new This section deals with the following subjects: owner. About this manual MANUAL CONTENT Use restrictions This manual contains the Instructions for Use and for maintenance of the following sterilizer versions: This manual contains the Instructions for Use and for maintenance About this manual...

  • Page 9: Use Restrictions

    Introduction The information contained in this document is subject to change USER QUALIFICATION without prior notice. The users who may operate the sterilizer are the following. User Competences qualification Use restrictions Head of the Legally responsible for:   the efficiency of the hygiene protocol in place clinic/practice INTENDED USE  ...

  • Page 10: 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 11: Responsibility

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

  • Page 12: 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: 60.7 kg (133.8 lbs) Operating the sterilizer User interface menu Sterilizer setup...
  • Page 13 Getting started WARNINGS CONTENTS OF THE PACKAGING 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.
  • Page 14 Getting started Power cord Drain tube USB pen drive loaded with This manual, declaration of Instructions for Use conformity, warranty card, work test report       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 5.5 l (1.45 gal))  ...

  • Page 15: Handling

    Getting started Handling HOW TO RELOCATE THE STERILIZER Before transport:   Completely drain both water tanks (see "Draining the used and clean water tank" on page  76)   Allow the sterilization chamber to cool down   Use original packaging when shipping or transporting the sterilizer.

  • Page 16: Product Description

    Getting started Product description FRONT VIEW Part Description Chamber door Clean water tank filling point Door locking system Touch screen Service door Sterilization chamber Safety thermostat reset Bacteriological filter Door gasket Clean tank cover-cap Clean water tank Tank internal filter with metal cartridges Lara XL ...
  • Page 17 Getting started COMPONENTS BEHIND THE SERVICE DOOR Part Description Mains switch USB port Emergency door opening tool Identification label Used water drain connection (grey) Clean water drain connection (blue) Drain tube release buttons Port for emergency door opening tool Lara XL  | Instructions for Use |  RIS-311 ENG Rev02 |  01/06/2022 |  © W&H Sterilization Srl...
  • Page 18 Getting started REAR VIEW Part Description LAN port USB ports Pressure safety valve cover Used water drain Water supply inlet Condenser grid Power cord guides Power cord socket Lara XL  | Instructions for Use |  RIS-311 ENG Rev02 |  01/06/2022 |  © W&H Sterilization Srl...
  • Page 19 Getting started CHAMBER ACCESSORIES Part Description Tray Chamber rack. It can host trays or cassettes inserted horizontally or vertically. Lara XL  | Instructions for Use |  RIS-311 ENG Rev02 |  01/06/2022 |  © W&H Sterilization Srl...

  • Page 20: Installing The Sterilizer

    Getting started Installing the sterilizer Clearance requirements to ensure proper air circulation: 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 cord.
  • Page 21 Getting started The electrical power supply of the sterilizer must fulfill all applicable FILLING THE CLEAN WATER TANK standards in the country of use, and must comply with the data label Notice: on the back of the sterilizer. Before carrying out the following steps, make sure that the sterilizer has completed the cycle in progress.
  • Page 22 Getting started   Press the push-button on top of the DRAINING THE USED AND CLEAN WATER TANKS quick connector to dislodge the Notice: drain tube. Before carrying out the following steps, make sure that the sterilizer has completed the cycle in progress. Always wear appropriate PPE during use of the sterilizer (e.g.
  • Page 23 Getting started LAN CONNECTION INSTALLING THE STERILIZER WARNING! In case of sterilizer malfunctions immediately unplug the sterilizer and call for service. Do not attempt to repair the sterilizer by yourself. Notice: Please ensure that all installation requirements are met before plugging the sterilizer.

  • Page 24: Operating The Sterilizer

    Getting started Operating the sterilizer HOMEPAGE DESCRIPTION Part Description POWER THE STERILIZER ON/OFF Title/purpose of the screen, or the cycle number and the   Press the power switch behind current date and time. the service door: once Available cycles. switched ON, the visual indicator on the power switch Note: The S Fast 134 cycle is optional, activated with Fast...

  • Page 25: User Interface Menu

    Getting started User interface menu DEVICE SETTING MENU FUNCTIONS Icon Label Function MAIN MENU FUNCTIONS Date & Time Sets date and time format, current date and time and time zone. Icon Label Function Menu Opens the menu. Display Sets the display brightness. Device Setting Sets the device.
  • Page 26 Getting started Icon Label Function Icon Label Function Test Prints a test label. Settings Only with a network connection set. Sets the parameters of the network location. Sterilizer Name Sets the sterilizer name. USB options Enables/disables USB warning messages. Cycle Sets the cycles menu.
  • Page 27 Getting started TRACEABILITY MENU FUNCTIONS Icon Function Label Icon Function Label Label Printer   Sets the maximum storage time of the wrapped sterilized items. Cycle History Shows all the sterilization cycles and tests and prints   Sets the automatic or manual printing of the reports and labels.
  • Page 28 Getting started COMMON COMMANDS AND ICONS Icon Function Icon Function Icon Function Gives information about the current   Aborts the action/function.   Moves to the previous screen function. Enters/exits the standby mode. without confirming/making any changes nor saving any parameters. Opens the homepage.
  • Page 29 Getting started Icon Function Increases/decreases the value. Indicates that the option is active/not active. Indicates that the option is enabled/disabled. Show an animation about the replacement procedure. Lara XL  | Instructions for Use |  RIS-311 ENG Rev02 |  01/06/2022 |  © W&H Sterilization Srl...

  • Page 30: Sterilizer Setup

    Getting started Sterilizer setup SET THE DATE AND TIME To change the date and time format, current date and time zone: GUIDED CONFIGURATION   On the homepage, tap > > At the first start- up of the sterilizer, the Guided Configuration  ...

  • Page 31: User Authentication

    Getting started User authentication CONNECT TO A NETWORK If you connect through an Ethernet cable, in most cases the sterilizer will connect to the network automatically. If it does not connect PIN MANAGEMENT automatically, or if you are using a Wi-Fi dongle key, follow the PIN “0000”...

  • Page 32: Elitrace (Optional)

    Getting started USB pen drive WHAT TO DO IF YOU FORGET YOUR PIN If... Then... DESCRIPTION you are a common user contact the administrator A USB pen drive is available to be installed in order to automatically you are the administrator contact your authorized service provider record all the sterilization cycle reports.
  • Page 33 Getting started used for a certain period of time, it automatically switches to Standby mode. ENTER THE STANDBY MODE MANUALLY   Homepage   EXIT THE STANDBY MODE or open or close the chamber door. CHANGING STANDBY MODE DELAY TIME   On the homepage, tap >...

  • Page 34: Administrator

    Administrator CONTENTS   Enter the new user name and tap to confirm. This section deals with the following subjects:   If desired, tap to give the administrator authority to the new user. User management Traceability options   to confirm:  the PIN of the new user is set to "0000" and Hide/Unhide a cycle a confirmation message appears.

  • Page 35: Traceability Options

    Administrator RESET A USER PIN SET THE TRACEABILITY OPTIONS   On the homepage, tap > >   On the homepage, tap > >   Tap your user name.   Tap your user name.   Enter the PIN and tap to confirm.  ...
  • Page 36 Administrator HIDE/UNHIDE A CYCLE   On the homepage tap > > >   Tap your user name.   Enter your PIN and tap to confirm.   to hide a cycle from the homepage.   to unhide a cycle from the homepage.  ...

  • Page 37: 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 38: Label Printer Usage (Optional)

    Managing printers   Depending on the LAN connection, take note of the Ethernet or SELECT AND CALIBRATE A LOCAL LABEL PRINTER Wi-Fi IP address.   On the homepage, tap > > >   Do not switch OFF the sterilizer until the whole procedure is  ...
  • Page 39 Managing printers code, please refer to the Activation code instructions provided with SET THE MANUAL LABEL PRINTING the label printer. The manual printing option permits the user at the beginning of a sterilization cycle to set manually the number of labels to print. AUTOMATIC PRINTING OPTION  ...

  • Page 40: Label Content Description

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

  • Page 41: 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 42 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 43 Sterilizer tests   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.   Wait until the end of the test and tap OPEN: the chamber door unlocks.  ...
  • Page 44 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 areas of the indicator sheet have not changed colour since there was an Repeat the test. If it fails air pocket during the cycle due to sterilizer malfunction.

  • Page 45: 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 46 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  ...

  • Page 47: Vacuum Test

    Sterilizer tests INTERPRET THE TEST RESULT Indicator What happened Test passed What to do next The indicator strip has turned dark. The air was completely removed from the capsule. Part of the chemical indicator strip has not turned dark. The air removal Repeat the test.
  • Page 48 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.

  • Page 49: Sterilization Cycles

    Sterilization cycles CONTENTS DENTAL HANDPIECE EXTERNAL DISINFECTION This section deals with the following subjects: This procedure reduces the risk of infection during cleaning and maintenance of the dental handpieces. Load maintenance and preparation   Wear protective gloves during disinfection. Prepare the sterilizer  ...
  • Page 50 Sterilization cycles DENTAL HANDPIECE EXTERNAL CLEANING CORRECT LOAD PLACEMENT This procedure involves the removal of residues (blood, dentine, WARNING! Do not overload trays and the chamber. Adhere etc.) that adhere to critical areas such as spray outlets, light ports, to the maximum load weight limits (see "Sterilization knurling etc.

  • Page 51: Prepare The Sterilizer

    Sterilization cycles PARTIAL LOAD Load type Placement If the chamber is just partially loaded, place the load in such a way On trays allowing adequate space in-between Pouched items that the space in-between the trays is maximized. Spread items bags. Ensure that packs do not touch the walls of evenly on multiple trays.

  • Page 52: Sterilization Cycle Description

    Sterilization cycles   To enjoy the full benefit of short cycle times when only one FILLING THE CLEAN WATER TANK tray is used, always place the load on the upper tray of the If no water system is connected you have to fill the tank: chamber rack and remove all other trays from the chamber.

  • Page 53: Sterilization Cycle Management

    Sterilization cycles Sterilization cycle management   On the homepage, tap the desired cycle. to display further cycles on S FAST 134 CYCLE ACTIVATION the next page, if any. To activate the S Fast 134 cycle is required the Fast Cycle activation code.
  • Page 54 Sterilization cycles   Check the cycle requirements.   If required, enter your credentials and confirm the load release.   Check the icon in the top left corner of the page to know the Note : the load release is possible only if the cycle is completed successfully.
  • Page 55 Sterilization cycles To program the sterilizer proceed as follows:   On the homepage, tap the cycle and     Tap the leaf icon to set the ECO DRY mode.   Load the chamber and close the chamber door.     Tap the ECO DRY mode you desire.
  • Page 56 Sterilization cycles SET THE DRYING TIME VIEW THE CYCLE PARAMETERS For each ECO DRY mode, the drying time is automatically adjusted to You can check the real time cycle parameters or the cycle the total amount of load and cannot be modified. To set a new drying parameters at the end of the cycle.
  • Page 57 Sterilization cycles END OF A STERILIZATION CYCLE STOP A STERILIZATION CYCLE When a cycle is successfully finished, the "Cycle completed" WARNING! You can stop the cycle at any time. Instruments message appears on the screen. To end the cycle: must not be considered sterile if this occurs before the DRY phase.

  • Page 58: Unloading

    Sterilization cycles Note: Water could be present in the chamber when opening the door. To STORED REPORT FORMAT prevent spilling place a towel below the chamber door. The summarized reports are stored in HTML format and the analytical reports in SCL format. All parameters are recorded every second. MESSAGES OF A STOPPED STERILIZATION CYCLE Following are the messages: WHAT HAPPENS WITH UNSAVED CYCLES...
  • Page 59 Sterilization cycles PRINT LABELS FOR A SPECIFIC CYCLE SET THE REMOTE FOLDER FOR SAVING THE REPORTS Note: Function available only with the Label printer activation code. To activate the remote storage and set the necessary parameters do the following:   On the homepage, tap >...
  • Page 60 Sterilization cycles TEST THE DATA STORAGE Note: The test function is available only if the remote data storage is enabled. See "Set the remote folder for saving the reports" on the previous page.   On the homepage, tap > >  ...
  • Page 61 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 62 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 Lara XL  | Instructions for Use |  RIS-311 ENG Rev02 |  01/06/2022 |  © W&H Sterilization Srl...

  • Page 63: Maintenance

    Maintenance CONTENTS Warnings for maintenance operations This section deals with the following subjects: WARNINGS Warnings for maintenance operations Ordinary maintenance WARNING! Turn the sterilizer OFF and remove the power cord before beginning any maintenance. Follow all health, Monthly or 50-cycle maintenance safety, cross-infection and cross-contamination 400-cycle maintenance protocols.

  • Page 64: Ordinary Maintenance

    Maintenance Ordinary maintenance EXPIRED MAINTENANCE The sterilizer monitors the wear of consumables by counting the number of cycles executed since the last replacement. MAINTENANCE BY THE USER When the number of cycles is close to the maximum, a pre-alert Frequency Cycles Operation about the concerned consumable is displayed.
  • Page 65 Maintenance REPLACE THE CONSUMABLE BEFORE THE MAINTENANCE DUE DATE If you replace the consumables before the request of replacement appears, you should manually reset the counters through the following procedure.   On the homepage, tap >   Select the consumable you want to replace: a message appears showing the current worked hours of the part.

  • Page 66: 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 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 or sharp objects.  ...
  • Page 67 Maintenance CLEANING THE CHAMBER AND THE CHAMBER ACCESSORIES Proceed as follows:   Remove the trays and the chamber rack.   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 68 Maintenance CLEANING THE CHAMBER FILTERS Proceed as follows:   Allow the sterilization chamber to cool down.   Empty the sterilizer chamber by removing the trays and the rack.   Remove the filters at the bottom of the chamber (bottom/center) by unscrewing them.

  • Page 69: 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  65. Proceed as follows:  ...

  • Page 70: 800-Cycle Or Biannual Maintenance

    Maintenance 800-cycle or biannual maintenance SEQUENCE OF PROCEDURES TO CLEAN THE WATER TANK To clean the water tank, proceed as follows:   "Prepare the sterilizer for cleaning the water tank" below "Prepare the sterilizer for cleaning the water tank" below.  ...
  • Page 71 Maintenance ACCESS TO THE WATER TANK Proceed as follows:   Lift the water tank cover. Lara XL  | Instructions for Use |  RIS-311 ENG Rev02 |  01/06/2022 |  © W&H Sterilization Srl...
  • Page 72 Maintenance CLEAN THE WATER TANK 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 moistened with water. For better cleaning results, clean with W&H MC-1000 cleaning solution.

  • Page 73: 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  65. Proceed as follows:  ...
  • Page 74 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.

  • Page 75: 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 Pneumatic connections effective operation of the sterilizer. Electrical connections A general check and service should be carried out every 4000 cycles Temperature and pressure calibration...

  • Page 76: 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 77: 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  ...

  • Page 78: 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  57 Repeat the cycle.
  • Page 79 Diagnostics Code Description Actions Wait before opening the chamber door. Allow the sterilization chamber to cool down. Repeat the cycle. If the problem persists, call service. Switch the sterilizer OFF and ON. Clean the chamber and the chamber furniture from residuals of detergents, disinfectants and other chemicals.
  • Page 80 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. Check the load does not exceed the MAXIMUM WEIGHT LIMITS. Clean water error (bad quality, clean tank low level, high consumption of water). Repeat the cycle.
  • Page 81 Diagnostics MESSAGES AND ALERTS Notice: For any error not listed in this table, call technical service. Message/Alert Description Action Fill clean water tank. There is not enough water in the tank to perform a Fill the water tank as requested. cycle.
  • Page 82 Diagnostics Message/Alert Description Action Door Gasket replacement is due. These messages advise that one consumable must Replace the consumable and tap to reset the counter (See "Maintenance" on be replaced. page  63). 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 some cycles.

  • Page 83: Troubleshooting

    Diagnostics Troubleshooting ERROR PAGE During the sterilization cycle, the sterilizer is continuously monitored by a control system. If an anomaly is detected, the cycle is aborted MANAGING ERRORS automatically, and the sterilizer starts a reset phase. If during a sterilization cycle an error occurs do the following: The following page appears:  ...
  • Page 84 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:  ...
  • Page 85 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 86 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 87 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  102. 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 88: 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 89 Diagnostics   Remove the power connection (back side)   Release the chamber pressure through the ring of the safety valve (sterilizer rear side) or wait three hours until the pressure has naturally decreased to the environment pressure.   Extract the opening tool placed behind the service door  ...
  • Page 90 Diagnostics   Insert the opening tool into the hole and then turn it counterclockwise until the door is unlocked (proceed slowly until it stops). Lara XL  | Instructions for Use |  RIS-311 ENG Rev02 |  01/06/2022 |  © W&H Sterilization Srl...

  • Page 91: 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 92 Technical data STANDARD STERILIZATION CYCLES AVAILABLE There are four sterilization cycles available, all of them complying with the European Standard EN13060:   three B-type cycles   one S-type cycle (optional, activated with Fast Cycle cycle activation code. See "S Fast 134 cycle activation" on page  53) Cycle Cycle name Purpose...
  • Page 93 Technical data COMMON STERILIZATION CYCLE DATA Sterilization cycles   B Universal 134 B Prion / Extended 134 B Universal 121 S Fast 134 (optional)   134 °C (273 °F) 134 °C (273 °F) 121 °C (250 °F) 134 °C (273 °F ) Sterilization temperature 3.03 bar 3.03 bar...
  • Page 94 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   duration of the drying phase (if the ECO DRY mode is disabled)  ...
  • Page 95 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 B Universal 134 7.0 kg (15.4 lbs) 2.3 kg (5 lbs) B Prion / Extended 134 7.0 kg (15.4 lbs)

  • Page 96: 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. PV1 - PV3 Vacuum pulse (removal of air from the sterilizer chamber/load) PV1 - PV6 PP1 - PP2 Pressure pulse (steam generation)
  • Page 97 Technical data TYPE B STERILIZATION CYCLE PHASES All type B sterilization cycles feature the same basic pressure profile as shown in the graph below. The duration and the temperature sterilization phase differ between the various cycles. Lara XL  | Instructions for Use |  RIS-311 ENG Rev02 |  01/06/2022 |  © W&H Sterilization Srl...
  • Page 98 Technical data TYPE S STERILIZATION CYCLE PHASES (OPTIONAL) The S Fast 134 cycle is specifically designed to sterilize unwrapped instruments, for immediate use on patients, not requiring a complete drying. Thus, the drying phase of this cycle is short, making this cycle the fastest available. Lara XL ...

  • Page 99: Technical Data

    Technical data Technical data From -20 °C to +60 °C (from -4 °F to +140 °F ) / 0–90 % (with Storage temperature / rel. humidity empty tanks) Max altitude 3000 m asl WATER SUPPLY SYSTEM 0.6 bar (8.7 psi) Min.

  • Page 100: Recommendations For Validation

    Technical data Recommendations for validation STEAM GENERATOR 5 bar (72.51 psi) Pressure safety valve Safety thermostats 230 °C (446 °F) TEST VALIDATION POINTS Lara XL sterilizers can be validated in accordance to EN ISO 17665-1. DISTILLED OR DEMINERALIZED WATER For further details please refer to the Qualification/Validation guide Fulfilling EN 13060 Ann.

  • Page 101: Diagrams

    Technical data 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 national and local regulations. For water requirements see "Technical data" on page  99. Lara XL ...

  • Page 102: Water Quality

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

  • Page 103: Accessories, Spare Parts, Consumables

    Technical data Accessories, spare parts, consumables Picture Part Part number Tray holder F523001X Note: use only accessories, spare parts and consumables recommended by W&H. A812110X Drain tube kit with fittings Note: before purchasing, check that the accessories fulfill all applicable standards in the country of use.
  • Page 104 Technical data Picture Part Part number Picture Part Part number Label printer (label printer only) 19721109 Lifting strap F602001X Label printer USB connection kit 19721123 T801003X Kit Helix test (PCD + 30 strips)   USB connection cable   1 roll of 2100 labels  ...

  • Page 105: Authorized W&H Service Partners

    Technical data Authorized W&H service partners A list and a map with your nearest W&H service partner are available at www.wh.com. Lara XL  | Instructions for Use |  RIS-311 ENG Rev02 |  01/06/2022 |  © W&H Sterilization Srl...

  • Page 106: 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 covered and explained during the in-service? Workplace suitability W&H installation check-list Is the allocated countertop for the sterilizer levelled and flat? Yes Are the recommended ventilation indications of the allocated...
  • Page 107 Documentation forms Question Answer Question Answer Have you shown the Head of the clinic/practice how to Have you executed a B Universal 134 cycle program with the manually abort a cycle? tray rack and trays inserted? Have you shown the Head of the clinic/practice the Are all connections to the sterilizer well positioned and maintenance program and procedures? plugged (accessories, etc…)?
  • Page 108 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: +43 6274 6236-55 Fax: Ignaz-Glaser-Straße 53, Postfach 1 Mail 5111 Bürmoos Austria Lara XL  | Instructions for Use |  RIS-311 ENG Rev02 |  01/06/2022 |  © W&H Sterilization Srl...
  • Page 110 RIS-311 W&H Sterilization Srl Instructions for Use via Bolgara, 2 Brusaporto (BG) Rev02 Italy 01/06/2022 www.wh.com Subject to changes +39 035 66 63 000  ...

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