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W&H Med Lexa Plus Instructions For Use Manual

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Instructions for Use
RIS-311
RIS-311 Med - ENG - Rev04

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Summary of Contents for W&H Med Lexa Plus

  • Page 1 Instructions for Use RIS-311 RIS-311 Med - ENG - Rev04...

  • Page 3: Table Of Contents

    Sterilization cycle report USB pen drive Maintenance Standby mode Warnings for maintenance operations Administrator User maintenance User management (optional) 50-cycle or monthly maintenance Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 4 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 Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 5: Conformity

    Safety requirements for electrical equipment for measurement, control and laboratory use, general requirements ASME Boiler and pressure vessel code EN 13060 Small steam sterilizers Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © 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 ON (supply) IEC 60417- 5007 Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 9: Use Restrictions

    The processing of such loads may result in incomplete sterilization and/or damage to the autoclave. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 10 16.5 lbs (7.5 kg) (trays and cassettes included). Pouched Textile load on trays 4.4 lbs (2.0 kg) (trays excluded). Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 11: User Qualification

    (2.0 kg) (trays excluded). Unwrapped Instruments 4 minutes 270 °F 4 minutes and dental (132 °C) handpieces, up to 18 lbs (8.1 kg). Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 12: Safety Information

    (see "Run a sterilization cycle" on page  56). Do not drink any water that has been inside the sterilizer. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 13 USB ports saving. Intended use: Regularly backup the cycle reports to ensure to have a copy in case of cybersecurity events or incidents. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 14 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 Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 15: 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 16: Getting Started

    Installing the sterilizer Operating the sterilizer User interface menu Sterilizer setup ioDent User authentication (optional) EliTrace (optional) USB pen drive Standby mode Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 17 Note: the packaging of the product is environmentally friendly and can be Weight without box: 125.7 lbs (57 kg) disposed of by industrial recycling companies. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 18: Contents Of The Packaging

    CONTENTS OF THE PACKAGING Power cord Drain tube Sterilizer Trays (three + two) Emergency door opening tool Tube for drain connection Chamber rack Tray holder Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 19: Handling

    Allow the sterilization chamber to cool down. Use original packaging when shipping or transporting the sterilizer. Replacement packaging materials are available from Service W&H. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 20: Product Description

    Service door Sterilization chamber Safety thermostat reset HEPA filter Door gasket Clean tank cover-cap Clean water tank Tank internal filter with metal cartridges Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 21 Identification label Used water drain connection (grey) Clean water drain connection (blue) Drain tube release buttons Port for emergency door opening tool Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 22: Rear View

    LAN port USB ports Pressure safety valve cover Used water drain Water supply inlet Condenser grid Power cord guides Power cord socket Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 23 Getting started CHAMBER ACCESSORIES Part Description Tray Chamber rack. It can host trays or cassettes inserted horizontally or vertically. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 24: Installing The Sterilizer

    The installation of the sterilizer shall be performed by two authorized technicians using PPE (Personal Protective Equipment) according to applicable standards. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 25: Water Connections

    : the clean water tank and the used water tank. For this reason is necessary to periodically fill the clean water tank and draining the used water tank. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 26 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 27: Lan Connection

    "Technical data" on page  96. Insert the Wi-Fi dongle key in the USB port. Read the Instructions for Use provided with the Wi-Fi dongle key. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 28: Operating The Sterilizer

    Note: at the first start-up of the sterilizer, the Guided Configuration procedure automatically appears; see "Sterilizer setup" on page  35. . The homepage appears with the enabled sterilization cycles. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 29: 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 30 Shows the sterilizer name. status of the connection with the W&H monitoring server. Akidata status Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 31 Protects with a password the cycle start, the Shared Selects a printer connected to another sterilizer cycle stop and the load release. Printer (connected via local network). Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 32: Maintenance Menu Functions

    Displays the consumable replacement procedure videos. Door Gasket Water Shows the water information (conductivity, clean water tank level and dirty water tank remaining capacity). Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 33 Indicates the value that may be changed and appears by clicking on Confirms the active option and saves a setting or a parameter. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 34 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 35: Sterilizer Setup

    IT manager / network time zone). administrator. Tap the desired value. to confirm and go back to the previous page. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 36: Iodent

    If you want to disable the function another special code must be entered. Note: for more information contact your dealer. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 37: Pin Management

    WHAT TO DO IF YOU FORGET YOUR PIN If... Then... you are a common user contact the administrator you are the administrator contact your authorized service provider Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 38: Usb Pen Drive

    Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 39: Administrator

    WHO CAN MANAGE USERS AND RESET THEIR PIN Only a user with administrator rights can create and delete users and reset the PIN code of a user to "0000". Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 40: Traceability Options (Optional)

    If you want the user to check the load and release it as valid at > > > > the end of the cycle, tap to confirm and go back to the previous page. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 41: Hide/Unhide A Cycle

    Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 42: Managing Printers

    On the homepage, tap > > > Tap the model of the printer to use. to confirm and go back to the previous page. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 43: Label Printer Usage (Optional)

    The automatic printing option permits to automatically print a preset complete. number of labels after a successful sterilization cycle. The labels are Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 44 On the homepage, tap > > > Activate Manual printing. to confirm and go back to the previous page. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 45: 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 Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 46: Sterilizer Tests

    Validate the sterilizer performance in terms of: See "Vacuum test" on page  50. efficiency of the vacuum pump tightness of the pneumatic circuit Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 47: 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 48 / 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 49 The indicator sheet has changed colour (a uniform dark blue pattern). Note: for interpreting the test result follow the instructions of the PCD manufacturer. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 50: 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 51 Clean the chamber face side and the chamber filters (see "User 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 52: Sterilization Cycles

    The manufacturer’s warranty is void in case of damage adequate steam circulation. caused by chemicals. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 53 Items made from different On separate trays or wrapped/pouched. materials (stainless steel, carbon steel, aluminium, etc.) Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 54: Typical Loads

    Insert cassettes horizontally or vertically, or insert trays. See "Load maintenance and preparation" on page  52 for load requirements and "Chamber accessories" on page  23. Close the door. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 55: General Recommendations

    See "Sterilization programs" on page  89 for the full list of key program features, including sterilization time, temperature and recommended load type. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 56: Sterilization Cycle Management

    Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 57 30.45 psi at 275 °F 17.83 psi at 255.2 °F Max. pressure (2.1 bar) at (135 °C) (1.23 bar) at (124 °C) Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 58 Current cycle phase Stop button Button to open the cycle information page Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 59 Reprocess the load if necessary. Remove the load and stock it. CAUTION! Hot steam. Wait the steam to dissipate before opening the door. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 60: Unloading

    LAN . to print the report, or tap to save the report on the USB pen drive. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 61 USB. To check if the parameters entered are valid, see "Test the data storage " on the next page. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 62 Only the last 400 cycles in HTML and 5 cycles in SCL in the sterilizer memory can be saved in the remote folder. On the homepage, tap > > > > to start the remote saving. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 63 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 Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 64 Cycle validation (you can choose to accept or reject the Cycle Validation results): Summary Plateau time Min. temperature Chemical indicator Biological indicator Helix strip/s Tracking Tracking code for traceability management Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 65: Maintenance

    70. personnel from the working area. 1200 Replace the door gasket. See "Replacing the door Yearly gasket" on page  71. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 66 When you have replaced the consumable tap to confirm: the executed cycle counter is reset. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 70: 400-Cycle Maintenance

    Unscrew the HEPA filter by hand (counter-clockwise). Screw on the new HEPA filter (clockwise) and tighten it snug. Note: tap to see the animated replacement procedure. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 71: 1200-Cycle Or Yearly Maintenance

    Remove the used door gasket by hand. Carefully clean the seal seat and the inside face of the chamber door. Note: tap to see the animated replacement procedure. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 72 Insert the new seal and press first up and down. Press left and right. Make sure the door gasket is seated evenly. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 73: 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 74: 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 75: Diagnostics

    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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 76 If the problem persists, contact technical service. Wait for the chamber to cool down. Reset the safety thermostat (see "Extraordinary maintenance" on page  73). Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 77 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 78: Messages And Alerts

    See "Maintenance" on page  65. HEPA Filter must be replaced in ... cycles. Do you want to replace it now? Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 79 - The door gasket If the problem persists, contact technical service. If the problem persists contact the service. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 80: Troubleshooting

    On the homepage, tap > > : a list of the last errors appears. to save the list in the USB pen drive. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 81: Warning Messages

    WARNING! Do not use items on patients! Drying The load might be wet. interrupted WARNING! Wet items are for immediate use only! Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 82: 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 83: Troubleshooting Table

    One or more chamber filter caps not well-positioned. Mount the chamber filter caps properly (see "User maintenance" on page  65). Load incorrectly placed. See "Load maintenance and preparation" on page  52. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 84 Remove any objects interfering with the chamber door. Check the door does not force message appears. itself. against the load or the chamber furniture. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 85 Call service to order the requested component (door gasket, HEPA filter…). maintenance. maintenance of the sterilizer. See "User maintenance" on page  65 Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 86: 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). Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 87 Diagnostics Extract the opening tool placed behind the service door. Remove the cap. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 88 Insert the opening tool into the hole and then turn it counterclockwise until the door is unlocked (proceed slowly until it stops). Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 89: Technical Data

    Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 90 : these are profiles defined by ANSI/AAMI ST55 as dynamic-air-removal (pre-vacuum). These profiles can be enabled by the user. Some of the parameters can be adjusted by the user according to his needs (Plateau/Sterilization phase, dry time, etc.). These cycles are not FDA cleared. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 91 Pouched/unwrapped textile load on trays: 4.4 Pouched/unwrapped textile load on trays: 4.4 lbs (2.0 kg) lbs (2.0 kg) : the liquids are excluded. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 92 Values and cycle names could be different depending on country requirement. : the weight of trays is excluded. : the weight of trays and cassettes is included. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 93: 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 94 B-TYPE STERILIZATION CYCLE PHASES All B-type sterilization cycles feature different pressure profile, duration and temperature of the sterilization phase as shown in the graphs below. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 95 The S 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. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 96: Technical Data

    Max. RH 80% up to 88 °F (31 °C), linearly decreasing to 50% at 104 STEAM GENERATOR °F (40 °C) Pressure safety valve 72.51 psi (5 bar) Safety thermostats 446 °F (230 °C) Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 97: Recommendations For Validation

    *: usable space with standard rack and trays. With optional racks and trays, see Accessories, spare parts, consumables. Recommendations for validation TEST VALIDATION POINTS Part Description Hottest points Coldest points Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 98: Diagrams

    Technical data Diagrams CONNECTION DIAGRAMS Data communication Water system (*): for water requirements see "Water quality" on the next page. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 99: Water Quality

    Note 3: if hardness is greater than 150 mg/L, a water softener is recommended unless used for washing and the cleaning chemistry is Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 100: Accessories, Spare Parts, Consumables

    Usable space - Cassette size (mm): 180 x 155 x 385 Drain tube kit with fittings A812110X Emergency door opening tool S520009X Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 101 Lifting strap F602001X 1 roll of 2100 labels 1 wax/resin ribbon B&D test pack T800003X activation code instructions A810504X Roll of thermal paper Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 102: Authorized W&H Service Partners

    3 pieces) Authorized W&H service partners A list and a map with your nearest W&H service partner are available at med.wh.com. Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 103: Documentation Forms

    Have you removed all the protection covers from the Have you shown to the Head/personnel of the clinic/practice sterilizer and from all the ship-with? what the messages and alarms mean? Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...

  • Page 104: Installation Information

    Installer's signature: the sterilizer? Have you shown and explained to the Head/personnel of the clinic/practice the safety advise section? Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 105 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 Lexa Plus  | Instructions for Use |  RIS-311 Med ENG Rev04 |  22/05/2024 |  © W&H Sterilization Srl...
  • Page 106 RIS-311 Med W&H Sterilization Srl Instructions for Use via Bolgara, 2 Brusaporto (BG) Rev04 Italy 22/05/2024 med.wh.com Subject to changes +39 035 66 63 000...

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