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Technical data

MN-111 | Instructions for use | MN-111 W&H Med ENG Rev11 | 2019/01/25 | © 2019 W&H Sterilization Srl

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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.

Program

Sterilization Temperature

Sterilization Time

(settable)

Drying time

(settable)

Custom A

250 °F (121 °C)

30–60 minutes

30–60 minutes

Custom B

270 °F (132 °C )

4–30 minutes

3–60 minutes

Custom C

273 °F (134 °C)

4–30 minutes

3–60 minutes

STERILIZATION PROGRAM OPTIONS (220 V VERSION)

WARNING! The sterility of items processed unwrapped is compromised on exposure to non-sterile environments. Ensure that items are
dry when removed from the sterilizer. If the default drying time is not adequate for the load to be sterilized, additional drying time can
be added (see "Sterilization cycle management" on page 49). To load properly the sterilizer see "Prepare the sterilizer" on page 48.

Unwrapped

Wrapped Medium
Load

Wrapped Large
Load

Wrapped XL Load

Low Temperature

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-

removal: SFPP

Dynamic-air-

removal: SFPP

Dynamic-air-

removal: SFPP

Dynamic-air-removal: SFPP

Gravity displacement

Sterilization program type according EN 13060

Class S

Class S

Class S

Class S

Class S

Sterilization time (minutes)

4

4

4

4

30' 30"

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Summary of Contents for MN-111

Page 1: ...MN 111 110 V 220 V Instructions for use MN 111 W H Med ENG Rev11 ...

Page 2: ......

Page 3: ...by mode 33 Administrator 35 User management optional 35 Traceability options optional 38 Hide Unhide a cycle 38 Managing printers 40 Printer selection 40 Label printer selection optional 40 Label printer usage optional 42 Label content description 45 Sterilization cycles 46 Load maintenance and preparation 46 Typical loads 48 Prepare the sterilizer 48 Sterilization cycle management 49 Unloading 55...

Page 4: ...Srl Technical data 85 Sterilization programs 85 Sterilization program phases 90 Technical data 93 Recommendations for validation 94 Diagrams 95 Water quality 96 Accessories spare parts consumables 98 Authorized W H service partners 100 Documentation forms 101 W H installation check list 101 ...

Page 5: ...ical equipment for measurement control and laboratory use general requirements UL 61010 1 2012 Safety requirements for electrical equipment for measurement control and laboratory use general requirements ASME Boiler and pressure vessel code EN 13060 Small steam sterilizers ANSI AAMI ST55 2010 Table top steam sterilizers Standards and Directives Description IEC 61010 1 Safety requirements for elect...

Page 6: ...rile conditions e g non sterile instruments which could lead to fatal personal injury CAUTION Indicates a hazardous situation that if not avoided could result in minor or moderate injury SYMBOLS DISPLAYED ON THE PRODUCT Hot surfaces Risk of burns Hot steam Risk of burns Consult the Instructions for use for important cautionary information Consult the Instructions for use Do not dispose of with nor...

Page 7: ...roduct from its delivery through to decommissioning For this reason it should always be accessible to operators both online and offline Contact customer service in the event the manual is unavailable If the device is transferred always attach the manual for the new owner MANUAL CONTENT This manual contains the Instructions for use and for maintenance of the following sterilizer versions n MN 111 1...

Page 8: ...Load weight Sterilization Temperature Sterilization Time Drying Time recommended Pouches Medium Load Instruments and dental handpieces up to 3 lbs 1 4 kg 270 F 132 C 4 minutes 25 minutes Pouches Large Load Instruments and dental handpieces up to 6 lbs 2 7 kg 270 F 132 C 4 minutes 30 minutes Program Type of Load and Load weight Sterilization Temperature Sterilization Time Drying Time recommended Wr...

Page 9: ... Head of the clinic practice Legally responsible for n the efficiency of the hygiene protocol in place n the sterilization process n the operators training and training documentation n the correct operation and maintenance of the equipment Trained operators n Regularly attend the training for operating and using the sterilizer safely n Use the sterilizer according to the Head of the clinic practic...

Page 10: ...ther liquids over the sterilizer risk of electrical short circuits n Switch off the sterilizer and unplug the mains cable before inspecting carrying out maintenance or servicing the sterilizer n Ensure that the power receptacle the sterilizer is connected to is properly grounded n All electric devices connected to the sterilizer shall be of Insulation Class II double insulated or higher n Use only...

Page 11: ...al attacks It is recommended not to leave the machine unattended Responsibility USER RESPONSIBILITY n The user is responsible for the proper installation the correct use and maintenance of the sterilizer in accordance with these Instructions for use n The safety devices of the sterilizer are impaired when the product itself is not installed used and serviced in accordance with these Instructions f...

Page 12: ...g 12 Handling 14 Product description 15 Installing the sterilizer 19 Operating with the sterilizer 21 User interface menu 23 Sterilizer setup 29 User authentication optional 31 USB pen drive 32 Standby mode 33 Unpacking UNPACK THE STERILIZER CAUTION Heavy product The sterilizer must be removed from the box and transported by two authorized technicians Weight 105 8 lbs 48 kg ...

Page 13: ...se 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 CONTENTS OF THE PACKAGING Sterilizer Trays four Chamber rack Tray holder Power cord Drain tube ...

Page 14: ...ank draining volume larger than 1 84 gal 7 l n LAN cable for connecting the sterilizer to a network optional See Accessories spare parts consumables on page 98 for a full list of optional accessories Handling HOW TO RELOCATE THE STERILIZER Before transport n Completely drain both water tanks see Draining the used and clean water tank on page 71 n Allow the sterilization chamber to cool down n Use ...

Page 15: ...ed ENG Rev11 2019 01 25 2019 W H Sterilization Srl 15 Product description FRONT VIEW Part Description A Chamber door B Clean water tank C Door locking system D Touch screen E Service door F Sterilization chamber G Safety thermostat H HEPA filter I Door seal ...

Page 16: ...9 W H Sterilization Srl COMPONENTS BEHIND THE SERVICE DOOR Part Description A Mains switch B USBport C Emergency manual unlocking tool D Identification label E Used water drain port grey F Clean water drain port blue G Drain tube release buttons H Port for manual emergency door unlocking ...

Page 17: ... H Med ENG Rev11 2019 01 25 2019 W H Sterilization Srl 17 REAR VIEW Part Description A LAN port KIT B USBport C Pressure safety valve cover D Used water drain optional E Water supply inlet optional F Condenser grid G Power cord guides H Power cord socket ...

Page 18: ...8 MN 111 Instructions for use MN 111 W H Med ENG Rev11 2019 01 25 2019 W H Sterilization Srl CHAMBER ACCESSORIES Part Description A Tray B Chamber rack It can host trays or cassettes inserted horizontally or vertically ...

Page 19: ...e sterilizer must operate in a well ventilated room far from sources of heat and from flammable materials Place the sterilizer on a flat and level surface Clearance requirements to ensure proper air circulation ELECTRICAL CONNECTIONS All the cables and tubes connected on the rear side of the sterilizer must be placed far from the condenser grid e g using the available guides Notice Use only the co...

Page 20: ...ceeding those listed in these instructions See Feed water specifications EN 13060 on page 96 and Feed water specifications ANSI AAMI and AAMI TIR34 on page 97 Notice The maintenance of the external water filling system must be done in exact accordance with the Instructions for use given with the relevant system LAN CONNECTION OPTIONAL 1 Insert a standard Ethernet cable to in the LAN port of the st...

Page 21: ...nt flat and level surface 2 Open the chamber door remove all items except the chamber rack from the sterilizer and close 3 Remove all the plastic covers from the items 4 Optional Connect the used and clean water tubes on the rear 5 Optional Connect Ethernet cable See LAN connection optional on the previous page 6 Plug the power cord into the socket in the back of the sterilizer 7 Place the power c...

Page 22: ...e sterilizer automatically turns in standby mode See Standby mode on page 33 3 Tap The homepage appears with the enabled sterilization cycles HOMEPAGE DESCRIPTION Part Description A Title purpose of the screen or the cycle number and the current date and time B Available options or functions C Additional buttons used to navigate the menu ...

Page 23: ...Getting started MN 111 Instructions for use MN 111 W H Med ENG Rev11 2019 01 25 2019 W H Sterilization Srl 23 User interface menu STRUCTURE AND NAVIGATION optional with Activation code optional ...

Page 24: ... pages to monitor the performed cycle data and manage users and printing DEVICE SETTING MENU FUNCTIONS Icon Label Function Date Time Sets time and date values and format Display Sets the display backlight and contrast Standby Changes the standby mode delay USBPen Drive Opens the formatting page of the USBpen drive Format Formats the USBpen drive Printer Selects the printer model connected to the s...

Page 25: ... Only with a network connection set Opens the page to manage the remote storage Test Only with a network connection set Checks if the files can be copied to the specified location Save all Only with a network connection set Copies all the files in the specified location in the network Icon Label Function Settings Only with a network connection set Sets the parameters of the network location MAINTE...

Page 26: ...s the PIN code Options Optional activated with an activation code Administrator only Permits the following n identify and save the operator who starts the cycle and releases the load n Protect with a password the cycle starts the load release and the label printing Label Printer Only if the Label Printer menu has been activated with the Label printer activation code Permits the following n Sets th...

Page 27: ...ization summary Icon Function Indicates the value that may be changed and appears by clicking on it Confirms the active option and saves a setting or a parameter n Aborts the action function n Moves to the previous screen without confirming making any changes nor saving any parameters Indicates that the option is ON and allows to set it OFF by touching it Indicates that the option is OFF and allow...

Page 28: ...NG Rev11 2019 01 25 2019 W H Sterilization Srl 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 ...

Page 29: ...nt date and time 1 On the homepage tap 2 Tap the value you want to change time date format the highlighted value can be changed 3 Tap or to change the value 4 Tap to confirm SET THE STERILIZER NAME To change the sterilizer name that appears in the cycle reports 1 On the homepage tap 2 Tap the text box a keyboard appears 3 Enter the new sterilizer name 4 Tap to confirm ...

Page 30: ...nformation about your network If your network supports dynamic IP skip this procedure Otherwise follow this procedure and enter the data suggested by your network administrator or IT manager 1 On the homepage tap 2 In IP Configuration tap Static the text boxes are enabled 3 Enter the data the frames highlight If a frame turns dark grey check and correct the entered data 4 In DNS Configuration tap ...

Page 31: ...ease refer to the Activation code instructions PIN MANAGEMENT PIN 0000 is assigned as default to each new user It has to be changed at the first login When the PIN is reset the default value 0000 is reassigned CHANGE YOUR PIN Change your PIN the first time you use the sterilizer and if your PIN has been reset This will prevent other users to use your account 1 On the homepage tap 2 Tap your user n...

Page 32: ...n order to automatically record all the sterilization cycle reports The USB pen drive can be inserted equally into the front or rear port Notice Periodically remove the USB pen drive to save the cycle data on a computer or on another safe support FORMAT THE USB PEN DRIVE 1 On the homepage tap 2 Insert the USB pen drive in one of the two USB ports 3 Tap 4 Tap to confirm all data will be erased Noti...

Page 33: ...e 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 ENTER THE STANDBY MODE MANUALLY 1 Homepage 2 Tap EXIT THE STANDBY MODE Tap or open or close the chamber door ...

Page 34: ...11 Instructions for use MN 111 W H Med ENG Rev11 2019 01 25 2019 W H Sterilization Srl Getting started CHANGING STANDBY MODE DELAY TIME 1 On the homepage tap 2 Tap or to change the delay time 3 Tap to confirm ...

Page 35: ... the user management functions the User management activation code must be entered The activation code is required only at the first access to the User Management or the Options menus To acquire the activation code please refer to the Activation code instructions 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 u...

Page 36: ...w user name and tap to confirm 7 If desired tap to give the administrator authority to the new user 8 Tap to confirm the PIN of the new user is set to 0000 and a confirmation message appears 9 Tap and then to go back to the previous page 10 Tap to return to the homepage DELETE A USER 1 On the homepage tap 2 Tap your user name 3 Enter the PIN and tap to confirm ...

Page 37: ...e 6 Tap to confirm RESET A USER PIN 1 On the homepage tap 2 Tap your user name 3 Enter the PIN and tap to confirm 4 Tap and the user name for which you want to reset the PIN 5 Tap to confirm the PIN is set to 0000 and a confirmation message appears 6 Tap to return to the homepage Note Remember the user to change their PIN before reusing the sterilizer ...

Page 38: ...de instructions WHO CAN SET THE TRACEABILITY OPTIONS Only a user with administrator rights can set the traceability options SET THE TRACEABILITY OPTIONS 1 On the homepage tap 2 Tap your user name 3 Enter your PIN and tap to confirm 4 Tap the information to be requested to the users at the beginning and at the end of the cycle 5 If you want the user to check the load and release it as valid at the ...

Page 39: ... W H Sterilization Srl 39 Administrator HIDE UNHIDE A CYCLE 1 On the homepage tap 2 Tap your user name 3 Enter your PIN and tap to confirm 4 Tap to hide a cycle from the homepage 5 Tap to unhide a cycle from the homepage 6 Tap to confirm and go back to the previous page ...

Page 40: ...rer importer 1 On the homepage tap 2 Tap the model of the printer to use 3 Tap to confirm and go back to the previous page Label printer selection optional FUNCTION AVAILABILITY To access the label printer functions the Label printer activation code must be entered The activation code is required only at the first access to the Label Printer menu To require the activation code please refer to the ...

Page 41: ...or to center it horizontally x and vertically y 6 If necessary tap to print another test label and repeat step 4 7 Tap to confirm the settings and go back to the previous page SELECT A SHARED LABEL PRINTER Note Function available only if the LAN Wi Fi connection has been activated optional 1 Ensure the sterilizer to which the printer is physically connected is ON and no cycle is running 2 From tha...

Page 42: ...rinter sharing 10 Tap to print a test label again Label printer usage optional CAUTION For your safety and the safety of your patients use a storage time compliant with the recommendations of the manufacturers of the containters packaging used and with applicable norms and rules FUNCTION AVAILABILITY To access the label printer functions the Label printer activation code must be entered The activa...

Page 43: ...omatic label printing a maximum storage time in weeks can be set This value is used to calculate the expiry date to be printed on the labels see Label content description on page 45 SET THE AUTOMATIC LABEL PRINTING 1 On the homepage tap 2 Activate Automatic printing 3 Tap or to set the maximum storage time and the number of labels to be printed automatically 4 Tap to confirm and go back to the pre...

Page 44: ...01 25 2019 W H Sterilization Srl Managing printers DISABLE THE LABEL PRINTING If the label printing is disabled no label can be printed at the end of a sterilization cycle 1 On the homepage tap 2 Activate Disabled 3 Tap to confirm and go back to the previous page ...

Page 45: ...re release B Traceability code alphanumerical and bar code Released Depending on the traceability settings this field may contain one of the following elements n the user who released the cycle n the user who started the cycle n the sterilizer ID Cycle Cycle name Number Cycle number Date Date and time of cycle start Expiry date n Expiry date of the bag package n The cycle outcome if a storage time...

Page 46: ...ty is void in case of damage caused by chemicals CLEANING THE INSTRUMENTS Clean all instruments thoroughly prior to sterilization If possible clean instruments immediately after use always follow the instrument manufacturer s instructions Remove all traces of disinfectants and detergents Rinse and dry carefully all instruments The instruments and tubes must be carefully rinsed and dried prior to s...

Page 47: ...t wise Pouched items On trays allowing adequate space in between bags Ensure that packs do not touch the walls of the chamber Place sterilization pouched items with the paper side facing up Empty containers or non perforated trays Upside down to prevent accumulation of water Items made from different materials stainless steel carbon steel aluminum etc On separate trays or wrapped pouched Instrumen...

Page 48: ... load used during the tests performed by W H is reported below Program Load example Wrapped Medium Load Wrapped Large Load Program Load example Wrapped XL Load Prepare the sterilizer WARNINGS Notice Use only distilled or demineralized water see Feed water specifications EN 13060 on page 96 for technical requirements Do not add any chemical additive to the water ...

Page 49: ... align the chamber rack at the center bottom of the chamber 2 Push the chamber rack gently into position until it clicks into place 3 Insert cassettes horizontally or vertically or insert trays See Load maintenance and preparation on page 46 for load requirements 4 Close the door 5 Turn the sterilizer switch ON after the inizialization the homepage appears GENERAL RECOMMENDATIONS Follow these reco...

Page 50: ...le information See View the cycle parameters on page 52 7 The sterilization is completed Tap to view the cycle summary or tap to view the cycle information See View the cycle parameters on page 52 8 Tap OPEN the door unlocks and the homepage appears DELAY THE STERILIZATION CYCLE START You may schedule the start of the sterilization cycles at a certain date and time e g if you want to load the ster...

Page 51: ...change the start time tap the time or the date a settings page opens 4 Tap the number you want to change and tap or to increase it or decrease it 5 Tap to confirm This date and time become the scheduled default start time for all next sterilization cycles 6 Tap to start the countdown for the current cycle Note You can decide to start the cycle immediately or stop the countdown at any time ...

Page 52: ...ization cycle 1 On the homepage tap the cycle and 2 Tap Dry time 3 Enter the value and tap to confirm This becomes the default dry time for the current sterilization program VIEW THE CYCLE PARAMETERS You can check the real time cycle parameters or the cycle parameters at the end of the cycle Following is an example 1 While the sterilization cycle is running or when cycle ends tap the cycle informa...

Page 53: ...on page END OF A STERILIZATION CYCLE When a cycle is successfully finished the Cycle completed message appears on the screen To end the cycle 1 Tap to view the cycle summary or tap to view the cycle parameters See View the cycle parameters on the previous page 2 Tap OPEN to open the door the door unlocks and the home page appears Note if an error message appears see Troubleshooting on page 80 CAUT...

Page 54: ...terile if this occurs before the DRY phase A cycle can be manually aborted at any time To stop a cycle 1 Tap STOP a confirmation request appears 2 Tap to abort the stop command The cycle continues programmed 3 Tap to abort the cycle the sterilizer starts a reset phase Notice Do not switch off the sterilizer during the reset phase it takes some time to reset the system and reach safe conditions in ...

Page 55: ...or MESSAGES OF A STOPPED STERILIZATION CYCLE Following are the messages n Load not sterile Do not use items on patients n Drying interrupted The load might be wet Wet items are for immediate use only Unloading WARNINGS CAUTION Risk of burns Before touching ensure the sterilization chamber is cold Always use the tray holder Sterilization cycle report WHERE CYCLE DATA ARE STORED The sterilizer store...

Page 56: ...rt is shown If still stored in memory the unsaved cycles will be copied in a working USB pen drive connected to the sterilizer as soon as a new cycle starts VIEW CYCLE HISTORY To view the sterilization cycle history 1 On the homepage tap all the sterilization cycles are listed with number date time and sterilization program The interrupted sterilization cycles appear in red 2 Scroll the list and t...

Page 57: ...print the report or tap to save the report on the USB pen drive PRINT LABELS FOR A SPECIFIC CYCLE Note Function available only with the Label printer activation code 1 On the homepage tap 2 Scroll the list and tap the desired sterilization cycle the report opens 3 Tap 4 Tap to print traceability labels for the selected cycle ...

Page 58: ...e confirmation all sterilization cycle reports are stored in the USB SET THE REMOTE FOLDER FOR SAVING THE REPORTS OPTIONAL To activate the remote storage and set the necessary parameters do the following 1 On the homepage tap 2 Tap to enable the remote data storage the first four fields in the page and the check box turn dark grey 3 In Path enter the name of the shared folder followed by the sub f...

Page 59: ... Tap to go back to the previous page 9 To check if the parameters entered are valid see Test the data storage optional below TEST THE DATA STORAGE OPTIONAL 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 previous page 1 On the homepage tap 2 Tap a sequence of tests is automatically performed 3 In case a...

Page 60: ... 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 1 On the homepage tap 2 Tap to start the remote saving ...

Page 61: ...of the executed cycle Cycle log number Cycle counter Exposure temp Programmed exposure temperature Exposure time Programmed exposure time Cycle start at Cycle start date and time Heating Phase Phase conditioning phases steam pressure pulses See Sterilization program phases on page 90 n Time phase duration n Partial xxxxxxx n T F maximum temperature n P psi maximum pressure Sterilization phase Phas...

Page 62: ...e n MIN P Min pressure n MAX P Max pressure n F0 value Drying Phase Phase Exhausting drying phase See Sterilization program phases on page 90 n Time phase duration n Partial xxxxxxx n T F maximum temperature n P psi maximum pressure Cycle completed Cycle end conditions Cycle outcome Cycle end at Cycle end date and time Cycle time Cycle duration Signature Operator signature Tracking Tracking code f...

Page 63: ...ff unauthorized personnel from the working area CAUTION Before accessing the chamber and the connected parts be sure that the sterilizer is cold Notice Follow the instructions in this chapter when carrying out any maintenance on the sterilizer Ordinary maintenance MAINTENANCE BY THE USER Frequency 1 Cycles 1 Operation Monthly 50 Cleaning the door seal and the chamber face side See Cleaning the doo...

Page 64: ...you have the requested spare part available buy one if not When the maximum number of cycles has been met a message to replace the consumable will be displayed 1 Tap to see an animated replacement procedure 2 When you have replaced the consumable tap to confirm the executed cycle counter is reset REPLACE THE CONSUMABLE BEFORE THE MAINTENANCE DUE DATE If you replace the consumables before the reque...

Page 65: ...cle maintenance CLEANING THE DOOR SEAL AND THE CHAMBER FACE SIDE Proceed as follows 1 Clean the door seal and the outer edge of the chamber with a non abrasive cloth moistened with clean water 2 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: ...ean 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 3 Rinse with water 4 Clean the trays and the chamber rack with a damp sponge and a mild detergent solution 5 Rinse with water 6 Reposition all pieces of the chamber accessories properly Note The trays and the tray holder may also be cleaned in ...

Page 67: ...moving the trays and the rack 3 Remove the filters at the bottom of the chamber bottom center by unscrewing them 4 Rinse the filters with tap water 5 Insert the filters in their original position screwing them into place CLEANING THE EXTERNAL SURFACES OF THE STERILIZER Proceed as follows 1 Clean all external sterilizer covers with a slightly damp cloth moistened with water Notice Never use disinfe...

Page 68: ...L 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 1 Open the chamber door 2 Remove the used door seal by hand 3 Carefully clean the seal seat and the inside face of the chamber door 4 Moisten the new seal with water ...

Page 69: ... MN 111 Instructions for use MN 111 W H Med ENG Rev11 2019 01 25 2019 W H Sterilization Srl 69 5 Insert the new seal and press first up and down 6 Press left and right 7 Make sure the door gasket is seated evenly ...

Page 70: ...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 1 Open the sterilizer door 2 Unscrew the HEPA filter by hand counter clockwise 3 Screw on the new HEPA filter clockwise and tighten it snug ...

Page 71: ...erilizer for at least seven days you have to drain the tanks 1 Open the sterilizer service door 2 Put a container below the sterilizer 1 84 gal 7 l minimum and place the end of the drain tube in it 3 To drain the used water insert the drain tube connector in the grey port 4 To drain the clean water insert the drain tube connector in the blue port 5 When the water has been completely drained press ...

Page 72: ...t must be reset manually Proceed as follows 1 Wait for the sterilizer to finish the error reset phase and follow the instructions on the display 2 Switch the sterilizer OFF and remove the mains cable 3 Wait for the sterilizer to cool down 4 Open the sterilizer door 5 Unscrew the cap and push on the reset button of the thermostat switch 6 A click sound indicates that the thermostat switch has been ...

Page 73: ... personnel to serious risk CAUTION High temperature Risk of burns Execute the following procedure only when the sterilizer has completely cooled down The sterilizer should be unplugged from the mains power supply since 3 hours at least Notice Execute this procedure only as indicated and with the sterilizer in the indicated conditions Any attempt to open the door in a different way can seriously da...

Page 74: ...l 2 Remove the power connection back side 3 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 4 Extract the door opening tool placed behind the service door 5 Remove the cap ...

Page 75: ...11 Instructions for use MN 111 W H Med ENG Rev11 2019 01 25 2019 W H Sterilization Srl 75 6 Insert the opening tool in the hole and then turn it counterclockwise until the door is unlocked proceed slowly until it stops ...

Page 76: ...e made of n Drop the sterilizer with a company that specializes on the recycling of related products n Do not abandon the sterilizer in unsecured places n Always refer to current applicable laws and rules in the country of use 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 c...

Page 77: ...ption and actions Actions 0xx Load cannot be considered sterile See End of a sterilization cycle on page 53 Repeat the cycle If the problem persists call service Check if the mains switch or network circuit breaker is OFF Check if the mains cable is properly connected Switch the sterilizer OFF and ON Set date and time then switch the sterilizer OFF and ON Ensure that the sterilizer fan is not bloc...

Page 78: ...minated with chemicals Ensure all the load is clean rinsed and free from any chemicals before sterilizing 13xto 16x Check water level in the clean water tank Reset the thermal overload Repeat the cycle If the problem persists call service Switch the sterilizer OFF and ON Clean the door seal and the chamber face side Check if the load placed in the sterilization chamber complies with the MAXIMUM WE...

Page 79: ...the door seal Clean or replace it if necessary Repeat the cycle If the problem persists call service Clean the chamber face side Check the load does not exceed the MAXIMUM WEIGHT LIMITS 4xx 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 seal Clean or replace i...

Page 80: ...he sterilizer during the reset phase it takes some minutes to reset the system and reach safe conditions in the sterilizer chamber Notice Water could be present in the chamber when opening the door prevent spilling e g place a towel below the chamber door VIEW AND SAVE THE ERROR LOG 1 On the homepage tap a list of the last errors appears 2 Tap to save the list in the USB pen drive ERROR PAGE Durin...

Page 81: ... A Current sterilization cycle B Error number See Errors on page 77 C Warning messages D Open button that appears after the reset phase had finished WARNING MESSAGES Message Description Load not sterile The load is not sterile WARNING Do not use items on patients Drying interrupted The load might be wet WARNING Wet items are for immediate use only ...

Page 82: ...eplace the door seal Clean the chamber face side Internal leak Call technical service The cycle commences but there is no pressure temperature rise The thermal overload switch is open Reset the thermal overload switch See Extraordinary maintenance on page 71 Electric electronicfault Call technical service At the end of the cycle there is residual water in the chamber Sterilizer not properly levele...

Page 83: ...d maintenance and preparation on page 46 Scale deposits on the chamber Clean the chamber and use water of good quality See Water quality on page 96 Instruments are turning brown or black Incorrect temperature selected Select a sterilization cycle featuring a lower sterilization temperature Follow the instructions of the instrument manufacturer The cycle report printer does not work Printer not pro...

Page 84: ...vious cycle had finished and the standby mode delay has expired Press the standby button to exit At the end of the cycle the display reads Open the door but opening the door is impossible The HEPA filter is blocked See Emergency opening door on page 73 Call technical service if the problem persists Remove the HEPA filter to get the pressure released Replace the filter Note The HEPA filters need to...

Page 85: ... cycle program table and never exceed the maximum load weight limits specified in it Such actions could result in non sterile conditions at the end of the cycle could expose people to the hazard of cross infections are considered as an improper use of the sterilizer for which the manufacturer cannot be hold responsible An improper use of these profiles will result in wet load at the end of the cyc...

Page 86: ...ched instruments probes explorers mirrors etc 8 pouched dental handpieces Wrapped XL Load Wrapped Cassettes Instruments and dental handpieces up to 14 lbs 6 4 kg Pouches wrapped unwrapped and naked 270 F 132 C 4 wrapped Hygiene cassettes 8 x5 5 20 3 mm x13 8 mm 2 wrapped Restorative cassettes 8 x11 20 3 mm x27 9 mm 4 wrapped Exam cassettes 8 x3 20 3 mm x7 6 mm Unwrapped Unwrapped Instruments and d...

Page 87: ... of items processed unwrapped is compromised on exposure to non sterile environments Ensure that items are dry when removed from the sterilizer If the default drying time is not adequate for the load to be sterilized additional drying time can be added see Sterilization cycle management on page 49 To load properly the sterilizer see Prepare the sterilizer on page 48 Unwrapped Wrapped Medium Load W...

Page 88: ...No No No Yes Maximum load weight excluding trays instruments 18 lb 8 1 kg instruments 3 lb 1 4 kg instruments 6 lb 2 7 kg instruments 14 lb 6 3 kg included cassettes instruments 5 lb 2 2 kg included trays or textile 4 4 lb 2 kg Note 1 The total cycle time may vary depending on the type of load solid or porous the load weight and other factors STERILIZATION PROGRAM OPTIONS 110 V VERSION WARNING The...

Page 89: ...30 30 Drying time minutes Range 8 99 Recommended 8 Range 25 99 Recommended 25 Range 30 99 Recommended 30 Range 40 99 Recommended 40 Range 30 99 Recommended 30 Total program duration min 1 Full loaded including drying time 43 53 58 71 80 Load type Pouched wrapped instruments and dental handpieces No Yes Yes Yes Yes Unwrapped instruments and dental handpieces Yes Yes Yes Yes Yes Unwrapped cassettes ...

Page 90: ...his phase the unit controls the theoretical temperature pressure converted in temperature because of physical behaviour of water and the steam temperature inside the chamber The value must be between the sterilization temperature band and the difference between them must be lower than 35 6 F 2 C If the temperature drops below the sterilization temperature band a restart process procedure is automa...

Page 91: ...5 2019 W H Sterilization Srl 91 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 ...

Page 92: ... 92 MN 111 Instructions for use MN 111 W H Med ENG Rev11 2019 01 25 2019 W H Sterilization Srl LOW TEMPERATURE PRESSURE PROFILE Low Temperature sterilization program feature the following pressure profile 250 F 121 C ...

Page 93: ... LAN port optional Features Fully micro processor controlled process evaluation system according to EN13060 Programmable standby mode Max heat output 3000 kJ h 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 F 40 C Storage temperature rel humidity From 4 F to 140 F from 20 C to 60...

Page 94: ...0 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 water charge clean water 0 29 gal 1 1 l Used water 1 77 gal 6 7 l Recommendations for validation TEST VALIDATION POINTS Part Description Hottest points Coldest points ...

Page 95: ...MN 111 Instructions for use MN 111 W H Med ENG Rev11 2019 01 25 2019 W H Sterilization Srl 95 Diagrams CONNECTION DIAGRAMS Data communication Water system Note for water requirements see Water quality on the next page ...

Page 96: ...NEX C Contaminants minerals qualities Value Specification Evaporate residue 10 mg l Silicon oxide SiO2 1 mg l Iron 0 2 mg l Cadmium 0 005 mg l Lead 0 05 mg l Heavy metals excl iron cadmium lead 0 1 mg l Chloride 2 mg l Phosphate 0 5 mg l Conductivity at 20 C 15 µs cm pH value 5 7 Contaminants minerals qualities Value Specification Appearance colorless clean free from sediment Hardness 0 02 mmol l ...

Page 97: ...zation of a critical device Note 3 If hardness is greater than 150 mg L a water softener is recommended unless used for washing and the cleaning chemistry is capable of handling higher levels of hardness Note 4 For boiler treated steam most boilers are treated to maintain a pH of 7 5 or 8 5 Any treatment of water that goes into boilers should be in accordance with the sterilizer and boiler manufac...

Page 98: ...ture PART Part number Standard chamber rack F523030X Aluminium tray x4 F523211X Tray holder F523001X Drain tube kit with fittings A812110X optional Emergency system for door unlocking S520009X Picture PART Part number Drain tube S230903X Water quality sensor U381003x Mains cable U380119x 120 V U380120x 230 V Ethernet cable 3 m A801500X USBpen drive V000004X External printer 19721108 ...

Page 99: ...es Door seal F460535X Every 1200 cycles OPTIONALS Notice The kits must be installed by service technicians authorized by the manufacturer Picture PART Part number AWF kit 1 Automaticwater filling kit for pressurized sources X0513202X AWF kit 2 Automaticwater filling kit for unpressurized sources X0513203X 110 V X0513204X 220 V AWD kit 3 Automaticwater draining kit X051331X LAN cable kit 4 X051301X...

Page 100: ... W H Sterilization Srl 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 ...

Page 101: ...ctions of the Instructions for use of the sterilizer covered and explained during the in service Yes No Workplace suitability 8 Is the allocated countertop for the sterilizer levelled and flat Yes No 9 Are the recommended ventilation indications of the allocated area for the sterilizer respected Yes No 10 Are the required minimum clearances respected Yes No 11 Have you explained which water qualit...

Page 102: ...oad type for each available sterilization program Yes No 23 Have you shown the head of the clinic practice how to prepare and place the load in the sterilizer chamber Yes No 24 Have you explained to the head of the clinic practice to use only original parts and accessories on the sterilizer Yes No 25 Have you shown and explained to the head of the clinic practice the safety advise section Yes No C...

Page 103: ......

Page 104: ...nc 6490 Hawthorne Drive Windsor ON N8T 1J9 Canada Manufacturer W H Sterilization Srl via Bolgara 2 Brusaporto BG Italy med wh com 39 035 66 63 000 MN 111 W H Med Instructions for use ENG Rev11 2019 01 25 Subject to changes ...

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