W&H lexa MN-111 100-125 V ac Instructions For Use Manual
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W&H lexa MN-111 100-125 V ac Instructions For Use Manual

W&H lexa MN-111 100-125 V ac Instructions For Use Manual

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MN-111 W&H Med - ENG - Rev11
MN-111 110 V / 220 V

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Summary of Contents for W&H lexa MN-111 100-125 V ac

  • Page 1 Instructions for use MN-111 W&H Med - ENG - Rev11 MN-111 110 V / 220 V...

  • Page 3: Table Of Contents

    Table of contents Conformity Managing printers Symbols and messages Printer selection Introduction Label printer selection (optional) About this manual Label printer usage (optional) Use restrictions Label content description Safety information Sterilization cycles Safety warnings Load maintenance and preparation Responsibility Typical loads Getting started Prepare the sterilizer Unpacking...
  • Page 4 Technical data Sterilization programs Sterilization program 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 MN-111  | Instructions for use |  MN-111 W&H Med ENG Rev11 |  2019/01/25 |  © 2019 W&H Sterilization Srl...

  • Page 5: Conformity

    Conformity Standards Description Directives CONFORMITY TO EUROPEAN AND AMERICAN STANDARDS AND IEC 61010-1 Safety requirements for electrical equipment for measurement, DIRECTIVES control and laboratory use, general requirements. STERILIZER featuring sterilization cycles conform with the following IEC 61010- Safety requirements for electrical equipment for measurement, standards: 2-040 control and laboratory use;...

  • Page 6: Symbols And Messages

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

  • Page 7: Introduction

    Introduction decommissioning. For this reason, it should always be accessible CONTENTS to operators both online and offline. This section deals with the following subjects: Contact customer service in the event the manual is unavailable. If About this manual the device is transferred, always attach the manual for the new Use restrictions owner.

  • Page 8: Use Restrictions

    Introduction All rights reserved in all countries. Type of Load and Sterilization Sterilization Drying Time Program All drawings, images and texts contained in this manual are the Load weight Temperature Time (recommended) property of the manufacturer. Even partial duplication of drawings, Wrapped Instruments and 40 minutes...
  • Page 9 Introduction USER QUALIFICATION The users who may operate the sterilizer are the following. User Competences qualification Head of the Legally responsible for: the efficiency of the hygiene protocol in place clinic/practice the sterilization process the operators' training and training documentation the correct operation and maintenance of the equipment Trained Regularly attend the training for operating and using the...

  • Page 10: Safety Information

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

  • Page 11: Responsibility

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

  • Page 12: Getting Started

    Getting started CONTENTS Unpacking This section deals with the following subjects: Unpacking UNPACK THE STERILIZER Handling CAUTION! Heavy product. The sterilizer must be removed Product description from the box and transported by two authorized technicians. Installing the sterilizer Weight: 105.8 lbs (48 kg) Operating with the sterilizer User interface menu Sterilizer setup...
  • Page 13 Getting started WARNINGS Notice: Check the external condition of the box and the sterilizer. In case of any damage, immediately contact the dealer or shipping agent that has carried out the transport. Keep the packaging for shipping or transporting the sterilizer in the future. Note: The packaging of the product is environmentally friendly and can be disposed of by industrial recycling companies.

  • Page 14: 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  71). Allow the sterilization chamber to cool down. Use original packaging when shipping or transporting the sterilizer.

  • Page 15: Product Description

    Getting started Product description FRONT VIEW Part Description Chamber door Clean water tank Door locking system Touch screen Service door Sterilization chamber Safety thermostat HEPA filter Door seal MN-111  | Instructions for use |  MN-111 W&H Med ENG Rev11 |  2019/01/25 |  © 2019 W&H Sterilization Srl...
  • Page 16 Getting started COMPONENTS BEHIND THE SERVICE DOOR Part Description Mains switch USB port Emergency manual unlocking tool Identification label Used water drain port (grey) Clean water drain port (blue) Drain tube release buttons Port for manual emergency door unlocking MN-111  | Instructions for use |  MN-111 W&H Med ENG Rev11 |  2019/01/25 |  © 2019 W&H Sterilization Srl...
  • Page 17 Getting started REAR VIEW Part Description LAN port (KIT) USB port Pressure safety valve cover Used water drain (optional) Water supply inlet (optional) Condenser grid Power cord guides Power cord socket MN-111  | Instructions for use |  MN-111 W&H Med ENG Rev11 |  2019/01/25 |  © 2019 W&H Sterilization Srl...
  • Page 18 Getting started CHAMBER ACCESSORIES Part Description Tray Chamber rack. It can host trays or cassettes inserted horizontally or vertically. MN-111  | Instructions for use |  MN-111 W&H Med ENG Rev11 |  2019/01/25 |  © 2019 W&H Sterilization Srl...

  • Page 19: Installing The Sterilizer

    Getting started Clearance requirements to ensure proper air circulation: Installing the sterilizer LOCATION REQUIREMENTS Notice: Do not place the sterilizer so that it is difficult to operate the controls behind the service door. Do not place the sterilizer so that it is difficult to disconnect the power cord.
  • Page 20 Getting started WATER CONNECTIONS LAN CONNECTION (OPTIONAL) The sterilizer clean water tank can be filled manually by the user or automatically with a water supply system. The water supply system must deliver demineralized or distilled water meeting the specifications listed in these instructions. Do not add any chemical/additive to the water.

  • Page 21: Operating With The Sterilizer

    Getting started INSTALLING THE STERILIZER Operating with the sterilizer WARNING! In case of sterilizer malfunctions immediately unplug the sterilizer and call for service. Do not attempt to POWER ON/OFF THE STERILIZER repair the sterilizer yourself. Press the power switch behind Notice: the service door: the visual Please refer to technical requirements before to plug the sterilizer!
  • Page 22 Getting started After a quick autotest the HOMEPAGE DESCRIPTION sterilizer automatically turns in Part Description standby mode. See "Standby mode" on page  33. Title/purpose of the screen, or the cycle number and the current date and time. Available options or functions.

  • Page 23: User Interface Menu

    Getting started User interface menu =  optional with Activation code STRUCTURE AND NAVIGATION = optional MN-111  | Instructions for use |  MN-111 W&H Med ENG Rev11 |  2019/01/25 |  © 2019 W&H Sterilization Srl...
  • Page 24 Getting started MAIN MENU FUNCTIONS DEVICE SETTING MENU  FUNCTIONS Icon Label Function Icon Label Function Menu Date & Time Opens the menu. Sets time and date values and format. Device Sets the device. Display Sets the display backlight and contrast. Setting Cycle History Standby...
  • Page 25 Getting started Icon Label Function Icon Label Function Test Prints a test label. Settings Only with a network connection set. Sets the parameters of the network location. Sterilizer Sets the sterilizer name. Name MAINTENANCE MENU  FUNCTIONS Icon Label Function Cycle Sets the cycles menu.
  • Page 26 Getting started Icon Function Label Administrator only. Adds a user. Add User Delete User Administrator only. Deletes a user. Reset user PIN Administrator only. Resets a user PIN code. code Change your Changes the PIN code. PIN code Optional, activated with an activation code. Administrator Options only.
  • Page 27 Getting started COMMON COMMANDS AND ICONS Icon Function Icon Function Icon Function Copy the error log/reports to the USB Indicates the value that may be pen drive. changed and appears by clicking on Enters/exits the standby mode. Confirms the active option and saves a setting or a parameter.
  • Page 28 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. MN-111  | Instructions for use |  MN-111 W&H Med ENG Rev11 |  2019/01/25 |  © 2019 W&H Sterilization Srl...

  • Page 29: Sterilizer Setup

    Getting started Sterilizer setup SET THE STERILIZER NAME To change the sterilizer name that appears in the cycle reports: SET THE DATE AND TIME On the homepage tap > > To change the current date and time: > Tap the text box: a keyboard On the homepage tap >...
  • Page 30 Getting started SET THE DISPLAY BRIGHTNESS SET THE NETWORK ADDRESS (OPTIONAL) To change the display brightness: Refer to your network administrator or IT manager for more information about your network. On the homepage tap > > If your network supports dynamic IP, skip this procedure. Otherwise follow this procedure and enter the data suggested by your network to change the value.

  • Page 31: User Authentication (Optional)

    Getting started On the homepage tap > > User authentication (optional) > Tap your user name. FUNCTION AVAILABILITY To access the user management functions the User management Enter your current PIN and tap activation code must be entered. The activation code is required to confirm.

  • Page 32: Usb Pen Drive

    Getting started WHAT TO DO IF YOU FORGET YOUR PIN FORMAT THE USB PEN DRIVE If you are... Then contact... On the homepage tap > > > a common user the administrator Insert the USB pen drive in one of the administrator your authorized service provider the two USB ports.

  • Page 33: Standby Mode

    Getting started Standby mode EXIT THE STANDBY MODE or open or close the chamber door. DESCRIPTION When in standby mode, the sterilizer display remains dark and the sterilizer chamber is not heated to save energy. If the sterilizer is not used for three hours, it automatically switches to standby mode.
  • Page 34 Getting started CHANGING STANDBY MODE DELAY TIME On the homepage tap > > to change the delay time. to confirm. MN-111  | Instructions for use |  MN-111 W&H Med ENG Rev11 |  2019/01/25 |  © 2019 W&H Sterilization Srl...

  • Page 35: Administrator

    Administrator CONTENTS ADD A USER This section deals with the following subjects: On the homepage tap > > > User management (optional) Traceability options (optional) Tap your user name. Hide/Unhide a cycle Enter the PIN and tap to confirm. User management (optional) FUNCTION AVAILABILITY To access the user management functions the User management activation code must be entered.
  • Page 36 Administrator Tap the text box:  a keyboard If desired, tap to give the appears. administrator authority to the new user. to confirm:  the PIN of the new user is set to "0000" and a confirmation message appears. and then to go back to the previous page.
  • Page 37 Administrator RESET A USER PIN On the homepage tap > > > Tap your user name. Enter the PIN and tap to confirm. Tap the user name you want to delete. to confirm. and the user name for which you want to reset the PIN. to confirm: ...

  • Page 38: Traceability Options (Optional)

    Administrator Tap the information to be requested Traceability options (optional) to the users at the beginning and at the end of the cycle. FUNCTION AVAILABILITY If you want the user to check the To access the user management functions the User management load and release it as valid at the activation code must be entered.
  • Page 39 Administrator HIDE/UNHIDE A CYCLE On the homepage tap > > > Tap your user name. Enter your PIN and tap confirm. to hide a cycle from the homepage. to unhide a cycle from the homepage. to confirm and go back to the previous page.

  • Page 40: Managing Printers

    Managing printers On the homepage tap > > CONTENTS > This section deals with the following subjects: Tap the model of the printer to use. Printer selection Label printer selection (optional) to confirm and go back to the previous page. Label printer usage (optional) Label content description Printer selection...
  • Page 41 Managing printers the shared label printer is connected to another sterilizer in the SELECT A SHARED LABEL PRINTER network. Note: Function available only if the LAN/Wi-Fi connection has been activated (optional). SELECT AND CALIBRATE A LOCAL LABEL PRINTER Ensure the sterilizer to which the printer is physically connected is On the homepage tap >...

  • Page 42: Label Printer Usage (Optional)

    Managing printers From the sterilizer from which the From the sterilizer to which the printer is not physically connected, printer is connected, confirm the tap homepage > > > > printer sharing. to print a test label again. Tap the text box and enter the IP address previously noted.
  • Page 43 Managing printers AUTOMATIC PRINTING OPTION SET THE MANUAL LABEL PRINTING The automatic printing option permits to automatically print a The manual printing option permits the user at the beginning of a preset number of labels after a successful sterilization cycle. The sterilization cycle to set manually the number of labels to print.
  • Page 44 Managing printers DISABLE THE LABEL PRINTING If the label printing is disabled, no label can be printed at the end of a sterilization cycle. On the homepage tap > > > Activate Disabled. to confirm and go back to the previous page. MN-111 ...

  • Page 45: Label Content Description

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

  • Page 46: Sterilization Cycles

    Sterilization cycles CONTENTS CLEANING THE INSTRUMENTS This section deals with the following subjects: Clean all instruments thoroughly prior to sterilization. If possible, clean instruments immediately after use; always follow the Load maintenance and preparation instrument manufacturer ‘s instructions. Remove all traces of Typical loads disinfectants and detergents.
  • Page 47 Sterilization cycles PARTIAL LOAD Load type Placement If the chamber is just 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 48: Typical Loads

    Sterilization cycles Typical loads Program Load example Wrapped XL Load EXAMPLES An example of a typical load used during the tests performed by W&H is reported below: Program Load example Wrapped Medium Load Wrapped Large Load Prepare the sterilizer WARNINGS Notice: Use only distilled or demineralized water (see "Feed water specifications (EN 13060)"...

  • Page 49: Sterilization Cycle Management

    Sterilization cycles To enjoy the full benefit of short cycle times, always place the FILLING THE CLEAN WATER TANK load on the uppertray of the chamber rack and remove other If no water system is connected you have to fill the tank: trays from the chamber.
  • Page 50 Sterilization cycles Check the cycle requirements. The sterilization is completed. Tap to view the cycle summary or to set a different start time. to view the cycle See "Delay the sterilization cycle information. See "View the cycle start" below. parameters" on page  52. : the door locks.
  • Page 51 Sterilization cycles On the homepage tap the cycle and to start the countdown for the current cycle. Note: You can decide to start the Tap Start cycle at. cycle immediately or stop the countdown at any time. If you want to change the start time, tap the time or the date: a settings page opens.
  • Page 52 Sterilization cycles SET THE DRYING TIME VIEW THE CYCLE PARAMETERS Dry time is set by default for each sterilization program. You can You can check the real time cycle parameters or the cycle change it and save it for the next sterilization cycle. parameters at the end of the cycle.
  • Page 53 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 Sterilization cycle name summary or tap to view the...
  • Page 54 Sterilization cycles STOP A STERILIZATION CYCLE to abort the stop command. The cycle continues programmed. WARNING! You can stop the cycle at any time. Instruments must not be considered sterile if this occurs before the DRY to abort the cycle: the phase.

  • Page 55: Unloading

    Sterilization cycles MESSAGES OF A STOPPED STERILIZATION CYCLE Check the message. See "Messages of a stopped Following are the messages: sterilization cycle" below. Load not sterile: Do not use items on patients! Drying interrupted: The load might be wet. Wet items are for Tap to view the cycle parameters.
  • Page 56 Sterilization cycles STORED REPORT FORMAT PRINT OR SAVE A CYCLE REPORT ON THE USB PEN DRIVE The summarized reports are stored in HTML format and the On the homepage tap > analytical reports in SCL format. All parameters are recorded every second.
  • Page 57 Sterilization cycles to print the report, or tap to save the report on the USB pen drive. PRINT LABELS FOR A SPECIFIC CYCLE to print traceability labels Note: Function available only with the Label printer activation code. for the selected cycle. On the homepage tap >...
  • Page 58 Sterilization cycles to increase or SET THE REMOTE FOLDER FOR SAVING THE REPORTS (OPTIONAL) decrease the number of label to be To activate the remote storage and set the necessary parameters printed. do the following: to save the set number for On the homepage tap >...
  • Page 59 Sterilization cycles TEST THE DATA STORAGE (OPTIONAL) Not mandatory. Enter the domain name. Note: The test function is available only if the remote data storage is enabled. See "Set the remote folder for saving the reports (optional)" on the to require the previous page.
  • Page 60 Sterilization cycles SAVE ALL THE CYCLE REPORTS IN A REMOTE FOLDER (OPTIONAL) Note: The save all function is available only if the remote data storage is enabled. See "Set the remote folder for saving the reports (optional)" on page  58. Only the last 400 cycles in HTML and 100 cycles in SCL in the sterilizer memory can be saved in the remote folder.
  • Page 61 Sterilization cycles CYCLE REPORT STRUCTURE Data Description Following the structure of a cycle report: Sterilizer brand and model Serial Number Sterilizer serial number SW version Software version number Local ID Surgery – practice – doctor name Cycle type Name of the executed cycle Cycle log number Cycle counter Exposure temp...
  • Page 62 Sterilization cycles Data Description Sterilization Exposure time MINT: Min. temperature Summary MAX T: Max. temperature MIN P: Min. pressure MAX P: Max. pressure F0 value Drying Phase Phase: Exhausting drying phase. See "Sterilization program phases" on page  90 Time: phase duration Partial: xxxxxxx T [F°]: maximum temperature P [psi] : maximum pressure...

  • Page 63: Maintenance

    Maintenance Notice: Follow the instructions in this chapter when carrying out any CONTENTS maintenance on the sterilizer. This section deals with the following subjects: Warnings for maintenance operations Ordinary maintenance Ordinary maintenance Monthly or 50-cycle maintenance 1200-cycle or yearly maintenance MAINTENANCE BY THE USER Extraordinary maintenance Emergency opening door...
  • Page 64 Maintenance Note : Even if the maximum cycle number is not reached, it is following procedure. recommended to replace the consumable parts every year, or if they appear worn or damaged, or if the filters are clogged or discolored. On the homepage tap >...

  • Page 65: Monthly Or 50-Cycle Maintenance

    Maintenance Monthly or 50-cycle maintenance CLEANING THE DOOR SEAL AND THE CHAMBER FACE SIDE Proceed as follows: Clean the door seal and the outer edge of the chamber with a non-abrasive cloth moistened with clean water. Rinse with clean water. Note: when the seal is new it might be necessary to hold the door gently closed at the sterilization start.
  • Page 66 Maintenance CLEANING THE CHAMBER AND THE CHAMBER ACCESSORIES Proceed as follows: Remove the trays and the chamber rack. Clean the chamber with a damp sponge and a mild detergent solution paying attention not to bend or damage the temperature probe inside the sterilizer chamber.
  • Page 67 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 68: 1200-Cycle Or Yearly Maintenance

    Maintenance 1200-cycle or yearly maintenance REPLACING THE DOOR SEAL 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  64. Proceed as follows: Open the chamber door.
  • Page 69 Maintenance Insert the new seal and press first up and down. Press left and right. Make sure the door gasket is seated evenly. MN-111  | Instructions for use |  MN-111 W&H Med ENG Rev11 |  2019/01/25 |  © 2019 W&H Sterilization Srl...
  • Page 70 Maintenance REPLACING THE HEPA 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  64. Proceed as follows: Open the sterilizer door. Unscrew the HEPA filter by hand (counter-clockwise).

  • Page 71: 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 72 Maintenance 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: Wait for the sterilizer to finish the error reset phase and follow the instructions on the display.

  • Page 73: Emergency Opening Door

    Maintenance Emergency opening door WARNING ABOUT OPENING THE DOOR IN EMERGENCY WARNING! High pressure. Risk of explosion, jet of hot steam, sudden opening of the door. Execute 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 74 Maintenance Remove the power connection (back side) Release the chamber pressure through the ring of the safety valve (sterilizer rear side) or wait three hours until the pressure has been naturally decreased to the environment pressure. Extract the door opening tool placed behind the service door Remove the cap MN-111 ...
  • Page 75 Maintenance Insert the opening tool in the hole and then turn it counterclockwise until the door is unlocked (proceed slowly until it stops). MN-111  | Instructions for use |  MN-111 W&H Med ENG Rev11 |  2019/01/25 |  © 2019 W&H Sterilization Srl...

  • Page 76: Disposal

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

  • Page 77: Diagnostic

    Diagnostic CONTENTS This section deals with the following subjects: Errors Troubleshooting Errors CHECKS AND ACTIONS Notice: For any error not listed in this table, call technical service. Code Description and actions Actions Load cannot be considered sterile. See "End of a Repeat the cycle.
  • Page 78 Diagnostic Code Description and actions Actions Wait before opening the chamber door. Allow the Repeat the cycle. sterilization chamber to cool down. If the problem persists, call service. Switch the sterilizer OFF and ON. Clean the chamber and the chamber furniture from residuals of detergents, disinfectants and other chemicals.
  • Page 79 Diagnostic Code Description and actions Actions Chamber filter clogged. Remove and clean the chamber Repeat the cycle. filter. See error "13x to 16x" on the previous page. If the problem persists, call service. Bacteriological filter clogged. Check and replace if necessary.

  • Page 80: Troubleshooting

    Diagnostic Troubleshooting VIEW AND SAVE THE ERROR LOG On the homepage tap > > : a list of the last errors appears. MANAGING ERRORS If during a sterilization cycle an error occurs do the following: to save the list in the USB pen drive.
  • Page 81 Diagnostic The following page appears: Part Description Current sterilization cycle Error number, See "Errors" on page  77 . Warning messages. Open button that appears after the reset phase had finished. WARNING MESSAGES Message Description The load is not sterile. Load not sterile WARNING! Do not use items on patients! The load might be wet.
  • Page 82 Diagnostic TROUBLESHOOTING TABLE 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. Activate the mains switch or network circuit breaker (ON).
  • Page 83 Diagnostic 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 84 Diagnostic 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  96. 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 85: Technical Data

    Technical data CONTENTS This section deals with the following subjects: Sterilization programs Sterilization program phases Technical data Recommendations for validation Diagrams Water quality Accessories, spare parts, consumables Authorized W&H service partners Sterilization programs WARNINGS WARNING! For your safety and for the safety of your patients: Never process objects different from those specified in the cycle program table and never exceed the maximum load weight limits specified in it.
  • Page 86 Technical data STANDARD STERILIZATION PROGRAMS The sterilizer offers six preset FDA cleared sterilization programs that comply with the American National Standard ANSI/AAMI ST55:2010: Ref. intended Sterilization Load example Program Recommended use Temperature Wrapped Pouches Instruments and dental handpieces, up to 3 lbs (1.4 kg). 40 pouched instruments (probes, explorers, 270 °F (132 °C) Medium Load...
  • Page 87 Technical data CUSTOM STERILIZATION PROGRAMS WARNING! The custom programs are not FDA cleared and it is the responsibility of the user to validate these programs. The sterilizer provides the following custom programs. These programs are disabled by default. Sterilization Time Drying time Program Sterilization Temperature...
  • Page 88 Technical data Wrapped Medium Wrapped Large Unwrapped Wrapped XL Load Low Temperature Load Load Drying time (minutes) Range: 8-99 Range: 25–99 Range: 30–99 Range: 40–99 Range: 30–99 Recommended: 8 Recommended: Recommended: Recommended: 40 Recommended: 30 Total program duration (min) Full loaded including drying time Pouched, wrapped instruments and Load type dental handpieces...
  • Page 89 Technical data Wrapped Medium Wrapped Large Unwrapped Wrapped XL Load Low Temperature Load Load Sterilization temperature 270 °F (132 °C) 270 °F (132 °C) 270 °F (132 °C) 270 °F (132 °C) 250 °F (121 °C) Sterilization program type according ANSI/AAMI Dynamic-air- Dynamic-air- Dynamic-air-...

  • Page 90: Sterilization Program Phases

    Technical data Sterilization program phases LEGEND OF THE STERILIZATION PROGRAM PHASES Following is the description of the sterilization phases. Code Phase Description Pre-heating Pre-heating of the sterilizer. This phase is not considered a part of the cycle. phase HEA1 Heating Initial heating phase to remove the air from the sterilization chamber.
  • Page 91 Technical data HIGH TEMPERATURE PRESSURE PROFILE Unwrapped, Wrapped Medium Load, Wrapped Large Load and Wrapped XL Load sterilization programs feature the same basic pressure profile (270 °F | 132 °C). The duration of the drying phase differ between the various programs. MN-111 ...
  • Page 92 Technical data LOW TEMPERATURE PRESSURE PROFILE Low Temperature sterilization program feature the following pressure profile (250°F | 121 °C). MN-111  | Instructions for use |  MN-111 W&H Med ENG Rev11 |  2019/01/25 |  © 2019 W&H Sterilization Srl...

  • Page 93: Technical Data

    Technical data Technical data INSTALLATION REQUIREMENTS Working temperature From +41 °F to +104 °F (from +5 °C to +40 °C) Working relative humidity Max. RH 80% up to 88 °F (31 °C), linearly decreasing to 50% at 104 WATER SUPPLY SYSTEM (TO BE COMPLIANT WITH IEC61770) °F (40 °C) Fitting Backflow preventing device (IEC61770).

  • Page 94: Recommendations For Validation

    Technical data STEAM GENERATOR Pressure safety valve 72.51 psig (5 bar) Safety thermostats 446 °F (230 °C) DISTILLED OR DEMINERALIZED WATER Water quality See the Test instructions service book (conductivity < 10μS/cm) Average water consumption 0.17 to 0.2 gal/cycle (0.65 to 0.75 litres/cycle) Tank volume Clean water 1.7 gal (6.4 l) Min.

  • Page 95: Diagrams

    Technical data Diagrams CONNECTION DIAGRAMS Data communication Water system Note (*): for water requirements see "Water quality" on the next page. MN-111  | Instructions for use |  MN-111 W&H Med ENG Rev11 |  2019/01/25 |  © 2019 W&H Sterilization Srl...

  • Page 96: Water Quality

    Technical data Water quality Contaminants/minerals/qualities Value/Specification Appearance colorless, clean, free from sediment FEED WATER SPECIFICATIONS (EN 13060) Hardness < 0.02 mmol/l Notice: Do not use rust inhibitor or any other agents in the clean No chemicals or additives must be added to the Chemical additives water tank.
  • Page 97 Technical data Notice: FEED WATER SPECIFICATIONS (ANSI/AAMI AND AAMI TIR34) The use of water with a conductivity greater than 10μS/cm may The table below lists the specifications for the water used for steam affect the sterilization process and damage the sterilizer. sterilization according ANSI/AAMI ST55:2010 and AAMI TIR34:2014.

  • Page 98: Accessories, Spare Parts, Consumables

    Technical data Accessories, spare parts, consumables Picture PART Part number Drain tube S230903X LIST OF ACCESSORIES AND SPARE PARTS Picture PART Part number Water quality sensor U381003x Standard chamber rack F523030X Mains cable U380119x (120 V) U380120x (230 V) Aluminium tray (x4) F523211X Ethernet cable, 3 m A801500X...
  • Page 99 Technical data CONSUMABLES OPTIONALS Notice: The kits must be installed by service technicians authorized Picture PART Part number When replace it by the manufacturer. HEPA  Filter W322400X Every 1200 cycles Picture PART Part number AWF kit 1 (Automatic water filling kit for X0513202X pressurized sources) Door seal...

  • Page 100: Authorized W&H Service Partners

    Technical data Authorized W&H service partners A list and a map with your nearest W&H service partner are available at http://wh.com. Alternatively please contact: W&H Impex Inc. 6490 Hawthorne Drive Windsor, ON, N8T 1J9 Canada Phone: +1 519 944 67 39 Fax: +1 519 974 61 21 Website: med.wh.com MN-111 ...

  • Page 101: Documentation Forms

    Documentation forms CONTENTS Question Answer This section deals with the following subjects: Completeness of the Instructions for use W&H installation check-list Were all sections of the Instructions for use of the sterilizer Yes No covered and explained during the in-service? Workplace suitability W&H installation check-list Is the allocated countertop for the sterilizer levelled and flat?
  • Page 102 Documentation forms INSTALLATION INFORMATION Question Answer MN-111 Serial Number: 17 Have you shown the Head of the clinic/practice the maintenance Yes No program and procedures? Date: 18 Have you shown the Head of the clinic/practice how to use all of Yes No Purchased from: the accessories?
  • Page 104 Importer MN-111 W&H Med W&H Impex Inc. Instructions for use 6490 Hawthorne Drive Windsor, ON, N8T 1J9 Rev11 Canada 2019/01/25 Subject to changes Manufacturer W&H Sterilization Srl via Bolgara, 2 Brusaporto (BG) Italy med.wh.com +39 035 66 63 000...

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Lexa mn-111 200-240 v ac

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