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W&S Lexa MN-111 Instructions For Use Manual
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W&S Lexa MN-111 Instructions For Use Manual

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Instructions for Use
MN-111 W&H Med - ENG - Rev12
MN-111

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Summary of Contents for W&S Lexa MN-111

  • Page 1 Instructions for Use MN-111 W&H Med - ENG - Rev12 MN-111...

  • Page 3: Table Of Contents

    Table of contents Conformity Managing printers Symbols and messages Printer selection (optional) 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...
  • 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 Rev12 |  2019/08/31 |  © 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 Contact customer service in the event the manual is unavailable. If CONTENTS the device is transferred, always attach the manual for the new This section deals with the following subjects: owner. About this manual MANUAL CONTENT Use restrictions This manual contains the Instructions for Use and for maintenance of the following sterilizer versions: MN-111 100–125 V ac About this manual...

  • Page 8: Use Restrictions

    Introduction All drawings, images and texts contained in this manual are the Type of Load and Sterilization Sterilization Drying Time property of the manufacturer. Even partial duplication of drawings, Program Load weight Temperature Time (recommended) images or text is prohibited. Unwrapped Instruments and 8 minutes...

  • Page 9: 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 10: Responsibility

    Safety information Instructions for Use. TAMPERING The safety devices of the sterilizer are impaired when the Do not remove the name plate or labels from the product itself is not installed, used and serviced in accordance sterilizer. with these Instructions for Use. Repairs, maintenance or service must be carried The Instructions for Use updated to the latest version is out by authorized service providers always using...

  • Page 11: 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 the sterilizer User interface menu Sterilizer setup...
  • Page 12 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 13: 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  72). Allow the sterilization chamber to cool down. Use original packaging when shipping or transporting the sterilizer.

  • Page 14: 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 reset HEPA filter Door gasket MN-111  | Instructions for Use |  MN-111 W&H Med ENG Rev12 |  2019/08/31 |  © 2019 W&H Sterilization Srl...
  • Page 15 Getting started COMPONENTS BEHIND THE SERVICE DOOR Part Description Mains switch USB port Emergency door opening tool Identification label Used water drain port (grey) Clean water drain port (blue) Drain tube release buttons Port for emergency door opening tool MN-111  | Instructions for Use |  MN-111 W&H Med ENG Rev12 |  2019/08/31 |  © 2019 W&H Sterilization Srl...
  • Page 16 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 Rev12 |  2019/08/31 |  © 2019 W&H Sterilization Srl...
  • Page 17 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 Rev12 |  2019/08/31 |  © 2019 W&H Sterilization Srl...

  • Page 18: 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 19 Getting started WATER CONNECTIONS FILLING THE CLEAN WATER TANK The sterilizer clean water tank can be filled manually by the user or Notice: automatically with a water supply system. The water supply Before carrying out the following steps, make sure that the sterilizer system must deliver demineralized or distilled water meeting the has completed the cycle in progress.
  • Page 20 Getting started Fill the clean water tank with a If the used water tank is almost full, water container (app. 1.7 gal (6.4 an alert appears on the display. l)). Notice: The water must be Open the service door at the front of demineralized or distilled meeting the sterilizer.
  • Page 21 Getting started Press the push-button on top of the LAN CONNECTION (OPTIONAL) quick connector to dislodge the drain tube. Insert a standard Ethernet Insert the other end of the cable to in the LAN port of cable in the LAN  port of your the sterilizer.

  • Page 22: Operating The Sterilizer

    Getting started INSTALLING THE STERILIZER Operating the sterilizer WARNING! In case of sterilizer malfunctions immediately unplug the sterilizer and call for service. Do not attempt to POWER THE STERILIZER ON/OFF repair the sterilizer by yourself. Press the power switch behind Notice: the service door: once Please ensure that all installation requirements are met before...
  • Page 23 Getting started After a quick autotest the HOMEPAGE DESCRIPTION sterilizer automatically turns in Part Description standby mode. See "Standby mode" on page  34. Title/purpose of the screen, or the cycle number and the current date and time. Available options or functions. Additional buttons used to navigate the menu.

  • Page 24: 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 Rev12 |  2019/08/31 |  © 2019 W&H Sterilization Srl...
  • Page 25 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 Setting Sets the device. Display Sets the display brightness. Cycle History Standby Shows all the sterilization cycles.
  • Page 26 Getting started Icon Label Function Icon Label Function Test Prints a test label. Save all Only with a network connection set. Copies all the files in the specified location in the network. Sterilizer Settings Sets the sterilizer name. Only with a network connection set. Sets the parameters Name of the network location.
  • Page 27 Getting started TRACEABILITY MENU FUNCTIONS Icon Function Label Optional, activated with an activation code. Permits User manage the users. Management 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.
  • Page 28 Getting started COMMON COMMANDS AND ICONS Icon Function Icon Function Icon Function Gives information about the current Aborts the action/function. Moves to the previous screen function. Enters/exits the standby mode. without confirming/making any changes nor saving any parameters. Opens the homepage. Moves to the previous/next screen.
  • Page 29 Getting started Icon Function Increases/decreases the value. Indicates that the option is active/not active. Indicates that the option is enabled/disabled. Show an animation about the replacement procedure. MN-111  | Instructions for Use |  MN-111 W&H Med ENG Rev12 |  2019/08/31 |  © 2019 W&H Sterilization Srl...

  • Page 30: 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 31 Getting started On the homepage tap > > SET THE DISPLAY BRIGHTNESS To change the display brightness: If the connection is through the On the homepage tap > > Ethernet cable, tap : the TCP/IP screen appears. to change the value. If the connection is through Wi-Fi to confirm.

  • Page 32: User Authentication (Optional)

    Getting started Note: in the TPC/IP screen, the only at the first access to the User Management ( ) or the Options icon is visible only if you make any ) menus: after the code was entered, the function is enabled and change.

  • Page 33: Usb Pen Drive

    Getting started Notice: Periodically remove the USB pen drive to save the cycle Enter your new PIN and tap data on a computer or on another safe support. confirm:  a confirmation message with your new PIN appears. FORMAT THE USB PEN DRIVE and then to go back to the previous page.

  • Page 34: 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 35 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 Rev12 |  2019/08/31 |  © 2019 W&H Sterilization Srl...

  • Page 36: 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 37 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 38 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 39: Traceability Options (Optional)

    Administrator Traceability options (optional) SET THE TRACEABILITY OPTIONS On the homepage tap > > > FUNCTION AVAILABILITY To access the user management functions the User Management Tap your user name. activation code must be entered. The activation code is required only at the first access to the User Management ( ) or the Options Enter your PIN and tap...

  • Page 40: Hide/Unhide A Cycle

    Administrator to hide a cycle from the Hide/Unhide a cycle homepage. to unhide a cycle from WHO CAN HIDE/UNHIDE A CYCLE the homepage. Only a user with administrator rights can hide a cycle or make it available to users on the homepage. to confirm and go back to the previous page.

  • Page 41: 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 (optional) Label printer selection (optional) to confirm and go back to the previous page. Label printer usage (optional) Label content description Printer selection (optional)
  • Page 42 Managing printers connected to the sterilizer, while the shared label printer is SELECT A SHARED LABEL PRINTER connected to another sterilizer in the 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 43: 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. again to print a test label. Tap the text box and enter the IP address previously noted.
  • Page 44 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 45 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 46: 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 47: 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 48 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 49: 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 MN-111  | Instructions for Use |  MN-111 W&H Med ENG Rev12 |  2019/08/31 |  © 2019 W&H Sterilization Srl...

  • Page 50: Prepare The Sterilizer

    Sterilization cycles Turn the sterilizer switch ON: after the initialization the Prepare the sterilizer homepage appears. WARNINGS GENERAL RECOMMENDATIONS Notice: Use only distilled or demineralized water (see "Feed water Follow these recommendations to obtain the most from the drying: specifications (EN 13060)" on page  96 for technical requirements). Ensure the paper side of the sterilization bags faces up, and Do not add any chemical / additive to the water.
  • Page 51 Sterilization cycles On the homepage tap the desired to view the cycle cycle. information. See "View the cycle parameters" on page  53. to display further cycles on the next page, if any. Check the cycle requirements. The sterilization is completed. Tap to view the cycle summary or to set a different start time.
  • Page 52 Sterilization cycles Tap the number you want to change DELAY THE STERILIZATION CYCLE START and tap to increase it or You may schedule the start of the sterilization cycles at a certain decrease it. date and time (e.g., if you want to load the sterilizer in the evening and run standard sterilization cycle early the next morning before to confirm.
  • Page 53 Sterilization cycles SET THE DRYING TIME Enter the value and tap Dry time is set by default for each sterilization program. The default confirm. This becomes the default drying time for each sterilization program can only be increased dry time for the current sterilization from the default value.
  • Page 54 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...
  • Page 55 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 56: 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 to view the cycle immediate use only! parameters.
  • Page 57 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 58 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 59 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 60 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 61 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  59. Only the last 400 cycles in HTML and 100 cycles in SCL in the sterilizer memory can be saved in the remote folder.
  • Page 62 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 63 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 64: 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 User maintenance User maintenance Monthly or 50-cycle maintenance 1200-cycle or yearly maintenance MAINTENANCE BY THE USER Extraordinary maintenance Disposal...
  • Page 65 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 66: Monthly Or 50-Cycle Maintenance

    Maintenance Monthly or 50-cycle maintenance CLEANING THE DOOR GASKET AND THE CHAMBER FACE SIDE Proceed as follows: Clean the door gasket 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 67 Maintenance CLEANING THE CHAMBER AND THE CHAMBER ACCESSORIES Proceed as follows: Remove the trays and the chamber rack. Clean the chamber with a damp sponge and a mild detergent solution paying attention not to bend or damage the temperature probe inside the sterilizer chamber.
  • Page 68 Maintenance CLEANING THE CHAMBER FILTERS Proceed as follows: Allow the sterilization chamber to cool down. Empty the sterilizer chamber by removing the trays and the rack. Remove the filters at the bottom of the chamber (bottom/center) by unscrewing them. Rinse the filters with tap water. Insert the filters in their original position, screwing them into place.

  • Page 69: 1200-Cycle Or Yearly Maintenance

    Maintenance 1200-cycle or yearly maintenance REPLACING THE DOOR GASKET Notice: If you replace this consumable before the maintenance due date you have to reset the cycle counter. See "Replace the consumable before the maintenance due date" on page  65. Proceed as follows: Open the chamber door.
  • Page 70 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 Rev12 |  2019/08/31 |  © 2019 W&H Sterilization Srl...
  • Page 71 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  65. Proceed as follows: Open the sterilizer door. Unscrew the HEPA filter by hand (counter-clockwise).

  • Page 72: 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 73: 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 74: Diagnostics

    Diagnostics 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 Actions Load cannot be considered sterile. See "End of a sterilization cycle" on page  54 Repeat the cycle.
  • Page 75 Diagnostics Code Description Actions Wait before opening the chamber door. Allow the sterilization chamber to cool down. Repeat the cycle. If the problem persists, call service. Switch the sterilizer OFF and ON. Clean the chamber and the chamber furniture from residuals of detergents, disinfectants and other chemicals.
  • Page 76 Diagnostics Code Description Actions Clean water error (bad quality, clean tank low level, high consumption of water). Repeat the cycle. If the problem persists, call service. Drain and/or refill the clean water tank. Check the door gasket. Clean or replace it if necessary. Check if there are hurdles on the door locking area (chamber rack, loads, objects, …).

  • Page 77: Troubleshooting

    Diagnostics 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 78 Diagnostics The following page appears: Part Description Current sterilization cycle Error number, See "Errors" on page  74 . 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 79 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 80 TROUBLESHOOTING TABLE Note: If your problem is not resolved, call your authorized service provider. Notice: Before sending the sterilizer for technical service, remove the mains cable, empty both water tanks and use the original or appropriate packaging. Problem Possible cause Solutions The sterilizer remains switched The mains switch or network circuit breaker is OFF.
  • Page 81 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. Use water of good quality. See "Water quality" on page  96. chemical substances.
  • Page 82 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 83: Emergency Door Opening

    Emergency door opening WARNING ABOUT OPENING THE DOOR IN EMERGENCY WARNING! High pressure. Risk of explosion, jet of hot steam, sudden opening of the door. Carry out the following procedure only if necessary and only when NO RESIDUAL PRESSURE IS IN THE CHAMBER. Any attempt to open the door while the unit is still hot or under pressure could expose the operator and the surrounding personnel to serious risk.
  • Page 84 Remove the power connection (back side) Release the chamber pressure through the ring of the safety valve (sterilizer rear side) or wait three hours until the pressure has naturally decreased to the environment pressure. Extract the opening tool placed behind the service door Remove the cap MN-111 ...
  • Page 85 Insert the opening tool into 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 Rev12 |  2019/08/31 |  © 2019 W&H Sterilization Srl...

  • Page 86: 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 87 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: Note : Mixture of instruments and/or packages within each program may vary. Not to exceed maximum load weight. CUSTOM STERILIZATION PROGRAMS WARNING! The custom programs are not FDA cleared and it is the responsibility of the user to validate these programs.
  • Page 88 Technical data Wrapped Medium Wrapped Large Unwrapped Wrapped XL Load Low Temperature Load Load Sterilization program type according EN 13060 Class S Class S Class S Class S Class S Sterilization time (minutes) 30' 30" Drying time (minutes) Range: 8–99 Range: 25–99 Range: 30–99 Range: 40–99...
  • 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 ST55:2010 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 steam generator and chamber. This phase is not considered a part of the cycle. phase HEA1 Heating...
  • Page 91 Technical data HIGH TEMPERATURE PRESSURE PROFILE All programs with the sterilization phase at 270 °F (132 °C) feature the same basic pressure profile 270 °F (132 °C). The duration of the drying phase differ between the various programs. MN-111  | Instructions for Use |  MN-111 W&H Med ENG Rev12 |  2019/08/31 |  © 2019 W&H Sterilization Srl...
  • Page 92 Technical data LOW TEMPERATURE PRESSURE PROFILE Low Temperature sterilization program features the following pressure profile 250°F (121 °C). MN-111  | Instructions for Use |  MN-111 W&H Med ENG Rev12 |  2019/08/31 |  © 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 psi (5 bar) Safety thermostats 446 °F (230 °C) DISTILLED OR DEMINERALIZED WATER Water quality See the Test instructions service book (conductivity : < 10μS/cm, Total Dissolved Solids: < 6.5 ppm) 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 Rev12 |  2019/08/31 |  © 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 (6.5 The table below lists the specifications for the water used for steam ppm) may 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 Mains cable U380119X (120 V) LIST OF PARTS PROVIDED WITH THE STERILIZER U380120X (230 V) Picture Part Part number Standard chamber rack F523030X USB pen drive V000004X CONSUMABLES Aluminium tray (x4) F523211X Picture Part...
  • Page 99 Technical data ACCESSORIES Part Picture Part number Part Picture Part number Multidem C27 - water demineralizer 19723112 Ethernet cable, 3 m A801500X USB hub 19721129 Cycle report printer 19721108 Multidem resin cartridge A812016X USB-serial adapter (for the connection of the A801503X cycle report printer) Label printer (label printer only)
  • Page 100 Technical data OPTIONAL KITS Notice: The kits must be installed by service technicians authorized by the manufacturer. Picture Part Part number Auto-fill kit with valve X051302X Auto-fill kit with pump X051303X (110 V) X051304X (220 V) Auto-drain kit X051331X LAN  cable kit X051301X MN-111 ...

  • Page 101: 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 med.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 102: 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 103 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 Rev12 Canada 2019/08/31 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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