W&H lara RIS-338 Instructions For Use Manual
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W&H lara RIS-338 Instructions For Use Manual

W&H lara RIS-338 Instructions For Use Manual

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Instructions for Use
RIS-338
RIS-338 - ENG - Rev01

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  • Page 1 Instructions for Use RIS-338 RIS-338 - ENG - Rev01...

  • Page 3: Table Of Contents

    Table of contents Conformity Traceability options Symbols and messages Hide/Unhide a cycle Introduction Managing printers About this manual Printer selection (optional) Use restrictions Label printer selection (optional) Label printer usage (optional) Safety information Safety warnings Label content description Responsibility Sterilizer tests Getting started Sterilizer performance tests Unpacking...
  • Page 4 400-cycle maintenance 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...

  • Page 5: Conformity

    Conformity CONFORMITY TO EUROPEAN REGULATIONS, STANDARDS AND Standards DIRECTIVES Description Directives Sterilizer conforms with the following Regulations, Standards and Directives: Electrical equipment for measurement, control and laboratory use IEC 61326-1 - EMC requirements; general requirements Standards IEC 61770 Electric appliances connected to the water mains - Avoidance of Description backsiphonage and failure of hose-sets Directives...

  • 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 USB connection GS1 datamatrix for logistic Transportation purpose Unique Device Identification Sterilizer type or model Medical Device Only for MDR devices Health Industry Bar Code in Test connection accordance with HIBC Serial Number Standard Small Steam Sterilizer Catalogue number This side up Max.

  • 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: RIS-338 200–240 V ac About this manual...

  • Page 9: Use Restrictions

    Introduction Use restrictions USER QUALIFICATION The users who may operate the sterilizer are the following. INTENDED USE User Competences For Medical Device in accordance with Regulation EU 2017/745: qualification The small steam sterilizers are intended for the sterilization of Head of the Legally responsible for: invasive and non-invasive medical devices.

  • 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 Safety information mass storage device, such as a pen drive, for cycle report TAMPERING saving; mass storage device, such as a pen drive, for software Do not remove the name plate or labels from update; the sterilizer. report printer Repairs, maintenance or service must be label printer carried out by authorized service providers QR code reader (seen as a keyboard), for EliTrace...
  • Page 12 Safety information Don't access the device web server functionality through A secure communication (with authentication and authorization) can links in e-mails. be established between the device and the cloud server for the Ensure the mail service provider has a spam filter. following functionalities: remote software update;...

  • Page 13: Manufacturer Responsibility

    Safety information frozen screen; The Instructions for Use updated to the latest version is always black screen; available at www.wh.com. significant slowdown when navigating the menus; Keep these Instructions for Use for future reference. malfunctioning or blocked network services (such as: remote data storage, label printer sharing, etc...).

  • Page 14: 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 with box: 71 kg (156.5 lbs) Operating the sterilizer Weight without box: 63 kg (138.9 lbs) User interface menu...

  • Page 15: Contents Of The Packaging

    Getting started CONTENTS OF THE PACKAGING Power cord Drain tube Sterilizer Trays (four + two) Emergency door opening tool Tube for drain connection Chamber rack Tray holder Lara XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 16: 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  78). Allow the sterilization chamber to cool down. Use original packaging when shipping or transporting the USB pen drive loaded with This manual, declaration of sterilizer.

  • Page 17: 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 XXL ...
  • Page 18 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 XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 19: Rear View

    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 XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 20 Getting started CHAMBER ACCESSORIES Part Description Tray Chamber rack. It can host trays or cassettes inserted horizontally or vertically. Lara XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 21: 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 22: Water Connections

    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 23 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 24: Lan Connection

    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 25: 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 current date and time. behind the service door: Available cycles. once switched ON, the visual indicator on the Note: the S Fast 134 cycle is optional, activated with Fast...

  • Page 26: User Interface Menu

    Getting started User interface menu DEVICE SETTINGS MENU FUNCTIONS Icon Label Function MAIN MENU FUNCTIONS Device Opens the pages to set the device. Note: this section describes the device functions. Please note that the availability of them depends on the device model and some of them might not be available for this model.
  • Page 27 Getting started Icon Label Function Icon Label Function Cycle Exclusion Remote Data Sets the cycles menu. Only with a network connection set. Opens the page Storage to manage the remote storage. Settings Measurement Only with a network connection set. Sets the Sets the unit of measure (temperature, water Units parameters of the network location.
  • Page 28 Getting started TRACEABILITY MENU FUNCTIONS Icon Function Label Icon Function Label Label Printer Optional, activated with an activation code. Enables/disables the printing of the labels. Cycle History Shows all the sterilization cycles and tests and prints Sets the automatic or manual printing of the reports and labels.

  • Page 29: Maintenance Menu Functions

    Getting started Icon Label Function Icon Label Function Test Prints a test label. System Installs and upload the software. Update Printer Selects the printer model connected to the sterilizer. The icon appears disabled if the printer/Ethernet cable/Wi-Fi dongle key is not connected. Special Saves the codes issued by the manufacturer to activate special functions.
  • Page 30 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. Moves to the previous/next screen. Indicates that the option is ON and Opens the homepage.
  • Page 31 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 XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 32: Sterilizer Setup

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

  • Page 33: Set The Display Brightness

    Getting started On the homepage, tap > > SET THE DISPLAY BRIGHTNESS To change the display brightness: If the connection is through the Ethernet cable, tap : the TCP/IP screen appears. On the homepage, tap > > > If the connection is through the Wi-Fi dongle key, tap : after a to change the value.

  • Page 34: Iodent

    Getting started ioDent On the homepage, tap > > Tap your user name. DESCRIPTION Enter your current PIN and tap to confirm. It allows to save the data securely and automatically on the cloud and it ensures intelligent and networked reprocessing of instruments, with a wide selection of smart solutions and options.

  • Page 35: Usb Pen Drive

    Getting started To acquire the activation code please refer to the activation code FORMAT THE USB PEN DRIVE instructions. Insert the USB pen drive in one USB port. DESCRIPTION On the homepage, tap > > EliTrace allows to know exactly which instruments were sterilized and link them to a specific cycle.
  • Page 36 Getting started EXIT THE STANDBY MODE or open or close the chamber door. CHANGING STANDBY MODE DELAY TIME On the homepage, tap > > > to change the delay time. to confirm and return to the previous page. Lara XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 37: 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 38: 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. Enter your PIN and tap to confirm.
  • Page 39 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. to confirm and return to the previous page. Lara XXL ...

  • Page 40: 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 41: Label Printer Usage (Optional)

    Managing printers From the sterilizer to which the printer is not physically SELECT AND CALIBRATE A LOCAL LABEL PRINTER connected, tap homepage > > > On the homepage, tap > > :  the local printer is located automatically. Tap the text box and enter the IP address previously noted. to center the printout properly in the label area.
  • Page 42 Managing printers printed only after the user has identified him/herself (with password DISABLE THE LABEL PRINTING if required) and the load has been checked and released, if these If the label printing is disabled, no label can be printed at the end of options have been enabled by the administrator.

  • Page 43: 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 the user who started the cycle the sterilizer ID Cycle...

  • Page 44: 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 45: Bowie And Dick Test

    Sterilizer tests Bowie and Dick 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 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 46 Sterilizer tests To set the duration of the Plateau/Sterilization phase and other settings, tap and enter your credentials if required: the chamber door locks. If you have not set a different start time (see "Set the sterilization cycle start" on page  57), the test starts immediately.
  • Page 47 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 48: 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 49 Sterilizer tests Place the tube with the capsule in the center of a tray in the lowest rack position and close the chamber door. To set the duration of the Plateau/Sterilization phase and other settings, tap and enter your credentials if required: the chamber door locks. If you have not set a different start time (see "Set the sterilization cycle start"...

  • Page 50: What To Do Next

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

  • Page 51: Vacuum Test

    Sterilizer tests Vacuum test CAUTION! Follow local/national guidelines on the frequency of testing. Notice: if a drainage period of the S Fast 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.
  • Page 52 Sterilizer tests On the homepage, tap Vacuum test. to see an animated description of the test steps. and enter your credentials if required: the chamber door locks. If you have not set a different start time (see "Set the sterilization cycle start" on page  57), the test starts immediately.

  • Page 53: 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 Avoid using abrasive disinfectants (pH-value 2.5 –...
  • Page 54 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 55: Prepare The Sterilizer

    Sterilization cycles PARTIAL LOAD Load type Placement If the chamber is only partially loaded, place the load in such a way Cassettes can be placed vertically or horizontally Cassettes that the space in-between the trays is maximized. Spread items into the chamber rack (vertical placement evenly on multiple trays.

  • Page 56: 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 57: Sterilization Cycle Management

    Sterilization cycles Sterilization cycle management If the door gasket is new, hold the door gently closed until the beginning of the cycle. and enter your credentials if required: the door locks. If S FAST 134 CYCLE ACTIVATION you have not set a different start time, the sterilization starts To activate the S Fast 134 cycle is required the Fast Cycle activation immediately.
  • Page 58 Sterilization cycles and run standard sterilization cycle early the next morning before SET THE DRYING TIME office hours). You can set the cycle start date and time and enable or The drying time of the AUTO DRY mode is automatically adjusted to disable it for each cycle.
  • Page 59 Sterilization cycles STERILIZATION CYCLE PAGE END OF A STERILIZATION CYCLE Following are the information displayed while a cycle is running: When a cycle is successfully finished, the "Cycle completed" message appears on the screen. To end the cycle: Part Description to view the cycle summary or tap to view the cycle Sterilization cycle name...

  • Page 60: Unloading

    Sterilization cycles Note: water could be present in the chamber when opening the door. To STOP A STERILIZATION CYCLE prevent spilling place a towel below the chamber door. WARNING! You can stop the cycle at any time. Instruments must not be considered sterile if this occurs before the MESSAGES OF A STOPPED STERILIZATION CYCLE DRY phase.
  • Page 61 Sterilization cycles to print the report, or tap to save the report on the STORED REPORT FORMAT USB pen drive. The summarized reports are stored in HTML format and the analytical reports in SCL format. All parameters are recorded every second. PRINT LABELS FOR A SPECIFIC CYCLE Note: function available only with the Label printer activation code.
  • Page 62 Sterilization cycles SET THE REMOTE FOLDER FOR SAVING THE REPORTS TEST THE DATA STORAGE To activate the remote storage and set the necessary parameters do Note: the test function is available only if the remote data storage is enabled. See "Set the remote folder for saving the reports" above. the following: On the homepage, tap >...
  • Page 63 Sterilization cycles CYCLE REPORT STRUCTURE Data Description Following is 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 64 Sterilization cycles Data Description Cycle end conditions Cycle water consumption F0 value H2O conductivity Cycle water conductivity Cycle time Cycle time Date (below) Cycle end date and time "Cycle completed" Cycle outcome Cycle validation (you can choose to accept or reject the Cycle Validation results): Summary...

  • Page 65: 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, 50-cycle or monthly maintenance safety, cross-infection and cross-contamination 400-cycle maintenance protocols.

  • Page 66: 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 67 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 68: 50-Cycle Or Monthly Maintenance

    Maintenance 50-cycle or monthly 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. Rinse with clean water.
  • Page 69 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. Rinse with water.
  • Page 70 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. Rinse the filters with tap water. Insert the filters in their original position, screwing them into place.

  • Page 71: 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  67. Proceed as follows: Open the service door.
  • Page 72 Maintenance PREPARE THE STERILIZER FOR CLEANING THE WATER TANK 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  78). To drain the detergent solution during the subsequent cleaning, leave the drain tube attached to the drain connection of the tank you want to clean.
  • Page 73 Maintenance ACCESS TO THE WATER TANK Proceed as follows: Lift the water tank cover. Lara XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 74: Clean The Water Tank

    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 75: 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  67. Proceed as follows: Fully open the chamber door.
  • Page 76 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 77: 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 78: 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 79: 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 in 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 80: 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, contact technical service. Code Description Actions Load cannot be considered sterile. See "End of a sterilization cycle" on page  59. Repeat the cycle.
  • Page 81 Diagnostics Code Description Actions Wait before opening the chamber door. Allow the sterilization chamber to cool down. Repeat the cycle. If the problem persists, contact technical service. Switch the sterilizer OFF and ON. Clean the chamber and the chamber furniture from residuals of detergents, disinfectants and other chemicals.
  • Page 82 Diagnostics Code Description Actions Check the door gasket. Clean or replace it if necessary. Repeat the cycle. If the problem persists, contact technical 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 83: Messages And Alerts

    Diagnostics MESSAGES AND ALERTS Notice: for any message/alert not listed in this table, contact technical service. Note: this section describes messages and alerts. Please note that the availability of them depends on the device model and some of them might not be available for this model.
  • Page 84 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  65). Have you replaced the door gasket? If you do not replace the consumable, tap In this case, you may still use the sterilizer but the message will appear again after some cycles.

  • Page 85: Troubleshooting

    Diagnostics Troubleshooting VIEW AND SAVE THE ERROR LOG On the homepage, tap > > : all the sterilization cycles MANAGING ERRORS are listed with number, date, time and sterilization program. The sterilization cycle interrupted because of a cycle error or If during a sterilization cycle an error occurs do the following: problem appears in red.

  • Page 86: Warning Messages

    Diagnostics WARNING MESSAGES Message Description Load not The load is not sterile. sterile WARNING! Do not use items on patients! Drying The load might be wet. interrupted WARNING! Wet items are for immediate use only! Lara XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 87: Reset The Safety Thermostat

    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 88: Troubleshooting Table

    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 89 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 90 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  103. 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 91: 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 92 Diagnostics Extract the opening tool placed behind the service door. Remove the cap. Insert the opening tool into the hole and then turn it counterclockwise until the door is unlocked (proceed slowly until it stops). Lara XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 93: 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 94 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  57) COMMON STERILIZATION CYCLE DATA Sterilization cycles B Universal 134...
  • Page 95 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 AUTO DRY mode is disabled). other factors.
  • Page 96 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. Note: in the standard configuration the weight of the tray is included. Instruments Wrapped and unwrapped Wrapped and unwrapped porous...

  • Page 97: 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 98 Technical data B-TYPE STERILIZATION CYCLE PHASES All B-type sterilization cycles feature the same basic pressure profile as shown in the graph below. The duration and the temperature of the sterilization phase differ between the various cycles. Lara XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 99 Technical data S-TYPE 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 XXL ...

  • Page 100: 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 (9843 ft) WATER SUPPLY SYSTEM 0.6 bar (8.7 psi) Min.

  • Page 101: Recommendations For Validation

    Technical data Recommendations for validation DISTILLED OR DEMINERALIZED WATER Fulfilling EN 13060 Ann. C (conductivity: < 15μS/cm, Total Water quality Dissolved Solids: < 10 ppm) TEST VALIDATION POINTS Average water 0.4 to 1.3 litres/cycle (0.11 to 0.34 gal/cycle Lara XXL sterilizers can be validated in accordance to EN ISO consumption 17665-1.

  • Page 102: Diagrams

    Technical data Diagrams CONNECTION DIAGRAMS Data communication Water system (*): the water filtration system must be fitted with a backflow prevention device complying to IEC 61770 and to national and local regulations. For water requirements see "Technical data" on page  100. Lara XXL ...

  • Page 103: 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 104: Accessories, Spare Parts, Consumables

    Technical data Accessories, spare parts, consumables LIST OF ACCESSORIES AND SPARE PARTS Picture Part Part number Note: use only accessories, spare parts and consumables recommended by Standard chamber rack for 6 F523043X W&H. aluminium trays Note: before purchasing, check that the accessories fulfill all applicable Usable space - Tray size (mm): standards in the country of use.
  • Page 105 Technical data Picture Part Part number Picture Part Part number Tray holder F523001X USB-serial converter A801503X Drain tube kit with fittings A812110X Label printer (label printer only) 19721109 Label printer USB connection kit 19721123 USB connection cable 1 roll of 2100 labels S520009X Emergency door opening tool 1 wax/resin ribbon...

  • Page 106: Activation Codes

    Technical data ACTIVATION CODES Picture Part Part number Activation code Description Part number Wi-Fi dongle key 19721136 EliTrace Activates the EliTrace function. 19730075 Fast Cycle Activates the Fast cycle. 19730071 Kit Helix test (PCD + 25 strips) T800206X Authorized W&H service partners CONSUMABLES A list and a map with your nearest W&H service partner are available Picture...

  • Page 107: 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? Helix test documentation form Workplace suitability Is the allocated countertop for the sterilizer levelled and flat? Yes W&H installation check-list...

  • Page 108: Installation Information

    Documentation forms Question Answer Question Answer Have you shown to the Head/personnel of the clinic/practice Have you explained to the Head/personnel of the how to manually abort a cycle? clinic/practice the cybersecurity information? Have you shown to the Head/personnel of the clinic/practice Have you explained to the Head/personnel of the the maintenance program and procedures? clinic/practice how to perform the B&D test?
  • Page 109 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 XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • 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 Lara XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 111 Documentation forms Date Cycle n. Operator Released Signature Chemical indicator Lara XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 112 Documentation forms Date Cycle n. Operator Released Signature Chemical indicator Lara XXL  | Instructions for Use |  RIS-338 ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 114 RIS-338 W&H Sterilization Srl Instructions for Use via Bolgara, 2 Brusaporto (BG) Rev01 Italy 29/11/2024 www.wh.com Subject to changes +39 035 66 63 000...

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