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W&H Med lara XXl Instructions For Use Manual

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

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

  • Page 3: Table Of Contents

    Sterilization cycle report USB pen drive Maintenance Standby mode Warnings for maintenance operations Administrator Ordinary maintenance User management 50-cycle or monthly maintenance Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 4 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 Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 5: Conformity

    Safety requirements for electrical equipment for measurement, control and laboratory use; particular requirements for sterilizers and washer-disinfectors used to treat medical materials Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 6: Symbols And Messages

    PROPERTY DAMAGE MESSAGES Notice: indicates information considered important, but not hazard-related. Typically to avoid damage to the product. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 7 Manufacturing date (YYYY- MM-DD) The sterilizer must be transported authorized technicians due Country of manufacture to its heavy weight Stand-by IEC 60417-5009 Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 8: Introduction

    The information contained in this document is subject to change decommissioning. For this reason, it should always be accessible to without prior notice. operators both online and offline. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 9: Use Restrictions

    The devices are intended for professional use by trained people only. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 10: Safety Information

    (see "Run a sterilization cycle" on page  56). Do not drink any water that has been inside the sterilizer. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 11 Use only trusted USB mass storage devices for report Intended use: saving. Regularly backup the cycle reports to ensure to have a copy in case of cybersecurity events or incidents. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 12 The device saves cycle data on the USB pen drive. Each file contains cybersecurity events: a control code that allows to check the file integrity. 4) Cloud secure communication Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 13: Manufacturer Responsibility

    The safety devices of the sterilizer are impaired when the product itself is not installed, used and serviced in accordance with these Instructions for Use. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 14: Getting Started

    Note: the packaging of the product is environmentally friendly and can be disposed of by industrial recycling companies. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 15: Contents Of The Packaging

    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 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 16: Handling

    LAN cable for connecting the sterilizer to a network (optional). See "Accessories, spare parts, consumables" for a full list of optional accessories. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 17: Product Description

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

  • Page 19: Rear View

    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 Med 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 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 21: Installing The Sterilizer

    The installation of the sterilizer shall be performed by two authorized technicians using PPE (Personal Protective Equipment) according to applicable standards. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 22: Water Connections

    : the clean water tank and the used water tank. sounds; stop filling. For this reason is necessary to periodically fill the clean water tank and draining the used water tank. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 23 Use left connector (blue, 1) for the clean water and the right connector (grey, 2) for the used water. Let the water flow from the tank completely. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 24: Lan Connection

    "Technical data" on page  99. Insert the Wi-Fi dongle key in the USB port. Read the Instructions for Use provided with the Wi-Fi dongle key. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 25: Operating The Sterilizer

    Note: at the first start-up of the sterilizer, the Guided Configuration procedure automatically appears; see "Sterilizer setup" on page  32. . The homepage appears with the enabled sterilization cycles. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 26: User Interface Menu

    Manages the sterilizer sounds. Accessories Opens the pages to accessories management. Cycle Opens the pages to manage cycles. Maintenance Carries out the maintenance procedure. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 27 Shows the sterilizer name. status of the connection with the W&H monitoring server. Akidata status Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 28 Protects with a password the cycle start, the cycle stop and the load release. Calibration Adjusts the label printer to the edge of the label. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 29: Maintenance Menu Functions

    Displays the cleaning procedure videos. Tank Cleaning Shows the number of cycles performed and left before 4000 Cycle Service the necessary maintenance. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 30 Indicates the value that may be changed and appears by clicking on Confirms the active option and saves a setting or a parameter. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 31 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 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 32: Sterilizer Setup

    > > to confirm. Tap the language you prefer. to return to the previous page. to confirm and return to the homepage. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 33: Set The Display Brightness

    IT manager / network each entry field and enter the IP addresses (ask your IT administrator. manager for details). Then tap to confirm. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 34: Iodent

    This will prevent other users from accessing your enabled and there is no need to enter the code again. account. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 35: Usb Pen Drive

    Notice: periodically remove the USB pen drive to save the cycle data Standby mode. on a computer or on another safe support. ENTER THE STANDBY MODE MANUALLY Homepage Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 36 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 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 37: Administrator

    Tap the user name you want to delete. Enter the PIN and tap to confirm. to confirm. Tap the text box:  a keyboard appears. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 38: Traceability Options

    WHO CAN SET THE TRACEABILITY OPTIONS available to users on the homepage. Only a user with administrator rights can set the traceability options. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 39 Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 40: Managing Printers

    On the homepage, tap > > Tap the model of the printer to use. to confirm and return to the previous page. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 41: Label Printer Usage (Optional)

    The automatic printing option permits to automatically print a preset number of labels after a successful sterilization cycle. The labels are Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 42 On the homepage, tap > > Activate Manual printing. to confirm and return to the previous page. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 43: Label Content Description

    Date and time of cycle start Expiry date of the bag/package. Expiry The cycle outcome if a storage time is not set. date Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 44: Sterilizer Tests

    Validate the sterilizer performance in terms of: See "Vacuum test" on page  51. efficiency of the vacuum pump tightness of the pneumatic circuit Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 45: Bowie And Dick Test

    (only with QR code / Bar code reader for labels connected). Place the B&D test pack in the center of a tray in the lowest rack position and close the chamber door. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 46 / Bar code reader for labels connected); the test report is saved in the HTML file. Note: for more information on test traceability, see the dedicated documentation. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 47 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. repeatedly, contact technical service. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 48: Helix Test

    Unscrew the tube capsule and place inside it an indicator strip according to the instructions of the test manufacturer. Screw the capsule. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 49 QR code; the test report is saved in the HTML file. Note: for more information on test traceability, see the dedicated documentation. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 50: 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  109. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 51: Vacuum Test

    Empty the sterilization chamber to ensure no load is present. Close the chamber door and ensure the sterilization chamber is completely dry and cold to avoid any false negative outcome. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 52 Clean the chamber face side and the chamber filters (see "Ordinary maintenance" on page  65). Repeat the Vacuum test. See "Carry out the test" on the previous page. If the test fails repeatedly, contact technical service. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 53: Sterilization Cycles

    The manufacturer’s warranty is void in case of damage chamber rack can damage the unit and could affect caused by chemicals. adequate steam circulation. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 54 Place sterilization pouched items with the paper side facing up. Empty containers or non- Upside down to prevent accumulation of water. perforated trays Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 55: Prepare The Sterilizer

    Insert cassettes horizontally or vertically, or insert trays. See "Load maintenance and preparation" on page  53 for load requirements and "Chamber accessories" on page  20. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 56: Sterilization Cycle Management

    Wait for the end of the sterilization. Tap to view the cycle parameters in real time. See "View the cycle parameters" on page  58. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 57 This becomes the new fixed value. Tap the time or the date: a settings page opens. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 58 Current cycle phase Open the chamber door. Stop button Remove the load and stock it. Button to open the cycle information page Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 59: Unloading

    USB pen drive or in a specific remote folder in the network if the sterilizer is connected to a LAN . Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 60 Scroll the list and tap the desired sterilization cycle: the report : after the confirmation all sterilization cycle reports are opens. stored in the USB. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 61 To check if the parameters entered are valid, see "Test the data storage " below. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 62 Plateau/Sterilization phase start: MIN, MAX temperature MIN, MAX pressure Plateau/Sterilization phase end Drying phase start Drying phase end Chamber venting phase Pressure leveling phase Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 63 Cycle validation (you can choose to accept or reject the Cycle Validation results): Summary Plateau time Min. temperature Chemical indicator Helix strip/s Trk. Tracking code for traceability management Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 64: Maintenance

    Notice: follow the instructions in this chapter when carrying out any maintenance on the sterilizer. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 65: Ordinary Maintenance

    : even if the maximum cycle number is not reached, it is recommended to replace the consumable parts every year, or if they appear worn or damaged, or if the filters are clogged or discolored. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 66 When you have replaced the consumable tap to confirm: the executed cycle counter is reset. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 67: 50-Cycle Or Monthly Maintenance

    Rinse with clean water. Note: when the seal is new it might be necessary to hold the door gently closed at the sterilization start. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 68 Note: tap to see the animated cleaning procedure. Note: the trays and the tray holder may also be cleaned in a washer disinfector. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 69 Notice: never use any other disinfectant, detergent or abrasive product, as they might result aggressive for the external covers and damage them. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 70: 400-Cycle Maintenance

    "Access to the water tank" on page  72. "Clean the water tank" on page  73. Note: tap to see the animated cleaning procedure. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 71 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. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 72 Maintenance ACCESS TO THE WATER TANK Proceed as follows: Lift the water tank cover. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 73: Clean The Water Tank

    Remove the internal filter. Clean the metal cartridge of the internal filter with tap water. Reposition the internal filter. Detach the drain tube. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 74: 800-Cycle Maintenance

    Carefully clean the seal seat and the chamber face side with a damp, lint-free cloth. Moisten the new seal with water to facilitate its placement. Note: tap to see the animated replacement procedure. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 75 Wipe any residual water and run a Vacuum and Helix test to check for perfect tightness of the seal. See "Vacuum test" on page  51 and "Helix test" on page  48"Helix test" on page  48. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 76: 4000-Cycle Or Five-Year Maintenance

    For each element, the actions to carried out are the following: Element Replace Clean Check Electro valves Vacuum pump internal parts Sterilization chamber and external surfaces Chamber filters Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 77: Extraordinary Maintenance

    To drain the clean water, insert the drain tube connector in the blue connection. When the water has been completely drained, press the release button to remove the drain tube and close the service door. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 78: Disposal

    The same instructions apply to disposal of all used consumable parts. MATERIALS The sterilizer is mainly built from fiber-reinforced polymers, metals and electric / electronic components. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 79: Diagnostics

    Check the dust filter and ensure that the sterilizer fan is not blocked. See error "13x to 16x" on the next page. Repeat the cycle. If the problem persists, contact technical service. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 80 If the problem persists, contact technical service. Wait for the chamber to cool down. Reset the safety thermostat (see "Extraordinary maintenance" on page  77). Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 81 Check if the door can move freely without touching the trays or the load when closing. Switch the sterilizer OFF and ON. The cycle has been aborted by the user. Re-process the load. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 82: Messages And Alerts

    ... cycles. cycles is close and the relevant maintenance step is to be scheduled. Have you already booked the 4000 cycle service? Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 83 - Door gasket If the problem persists, contact technical service. - Dust filter If the problem persists contact the service. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 84: Troubleshooting

    Current sterilization cycle Error number, See "Errors" on page  79 . Warning messages. Open button that appears after the reset phase had finished. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 85: Warning Messages

    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 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 86: Reset The Safety Thermostat

    Note: if the thermostat operates repeatedly, contact technical service. Wait for the sterilizer to finish the error reset phase and follow the instructions on the display. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 87: Troubleshooting Table

    One or more chamber filter caps not well-positioned. Mount the chamber filter caps properly (see "Ordinary maintenance" on page  65). Load incorrectly placed. See "Load maintenance and preparation" on page  53. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 88 Remove any objects interfering with the chamber door. Check the door does not force message appears. itself. against the load or the chamber furniture. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 89 Contact service to order the requested component (door gasket, dust filter, maintenance. maintenance of the sterilizer. bacteriological filter…). See "Ordinary maintenance" on page  65 Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 90: Emergency Door Opening

    Switch off the sterilizer and wait at least three hours until the pressure has naturally decreased to the environment pressure. Unplug the mains cable (back side). Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 91 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 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 92: Technical Data

    Processing bagged items with the S Fast 134 cycle will result in wet bags/pouches at the end of the cycle, exposing the items to contamination due to improper storage. The display reminds the maximum permitted load before starting a cycle. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 93 **: for all items that cannot withstand the high temperatures of the 134 cycles, such as textiles and plastics. : the liquids are excluded. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 94 B Prion / Extended 134 * B Universal 121 ** S Fast 134 33'30" 44'30" Note: values and cycle names could be different depending on country requirements. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 95 B Prion / Extended 134 * 12.0 kg (26.5 lbs) B Universal 121 ** 12.0 kg (26.5 lbs) S Fast 134 not suitable Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 96: Sterilization Cycle Phases

    Short phase to clean the circuit from used water. Leveling. Pressure inside the sterilization chamber is leveled to the atmospheric pressure. End of the cycle. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 97 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 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 98 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  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 99: Technical Data

    Max. RH 80% up to 31 °C (88 °F), linearly decreasing to 50% at 40 °C (104 °F) STEAM GENERATOR 5 bar (72.51 psi) Pressure safety valve Safety thermostats 230 °C (446 °F) Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 100: Recommendations For Validation

    *: usable space with standard rack and trays. With optional racks and trays, Part Description see Accessories, spare parts, consumables. Hottest points : the unit of measurement used is U.S. liquid gallons. Coldest points Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 101: Diagrams

    (*): 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  99. Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 102: Water Quality

    < 2 mg/l Phosphate < 0.5 mg/l Conductivity (at 20°C) < 15 µS/cm pH value 5–7 Appearance colorless, clean, free from sediment Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 103: Accessories, Spare Parts, Consumables

    190 x 155 x 545 Aluminium tray F523216X (185 x 17 x 550 mm) F523217X Large aluminium tray (214 x 17 x 550 mm) Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 104 Multidem C27 water demineralizer 19723112 Network data cable RJ45 (3 m) A801500X USB pen drive V000004X 19721134 Osmo water demineralizer (220 V) Report printer 19721141 Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 105: Authorized W&H Service Partners

    Components: 1 door gasket 2 bacteriological filters ACTIVATION CODES Activation code Description Part number EliTrace Activates the EliTrace function. 19730075 Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 106: Documentation Forms

    Have you shown to the Head/personnel of the clinic/practice Have you removed all the protection covers from the what the messages and alarms mean? sterilizer and from all the ship-with? Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 107: Installation Information

    Phone: Have you shown and explained to the Head/personnel of the clinic/practice the safety advise section? Receiver's signature: Installer's signature: Lara XXL  | Instructions for Use |  RIS-338 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 108 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 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...

  • Page 109: Helix Test Documentation Form

    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 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 110 Documentation forms Date Cycle n. Operator Released Signature Chemical indicator Lara XXL  | Instructions for Use |  RIS-338 Med 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 Med ENG Rev01 |  29/11/2024 |  © W&H Sterilization Srl...
  • Page 112 RIS-338 Med W&H Sterilization Srl Instructions for Use via Bolgara, 2 Brusaporto (BG) Rev01 Italy 29/11/2024 med.wh.com Subject to changes +39 035 66 63 000...

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