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Sterilization cycles

Data

Description

Sterilization
Summary

Exposure time

MINT: Min. temperature

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

"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 for traceability

Содержание Lexa MN-111

Страница 1: ...MN 111 Instructions for Use MN 111 W H Med ENG Rev12...

Страница 2: ......

Страница 3: ...34 Administrator 36 User management optional 36 Traceability options optional 39 Hide Unhide a cycle 40 Managing printers 41 Printer selection optional 41 Label printer selection optional 41 Label pr...

Страница 4: ...rl Technical data 86 Sterilization programs 86 Sterilization program phases 90 Technical data 93 Recommendations for validation 94 Diagrams 95 Water quality 96 Accessories spare parts consumables 98 A...

Страница 5: ...cal 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 requiremen...

Страница 6: ...ile 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 DISPLA...

Страница 7: ...very 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 tra...

Страница 8: ...0 minutes Wrapped Cassettes Instruments and dental handpieces up to 14 lbs 6 4 kg 270 F 132 C 4 minutes 40 minutes Program Type of Load and Load weight Sterilization Temperature Sterilization Time Dry...

Страница 9: ...er 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...

Страница 10: ...l 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 steriliz...

Страница 11: ...ng 11 Handling 13 Product description 14 Installing the sterilizer 18 Operating the sterilizer 22 User interface menu 24 Sterilizer setup 30 User authentication optional 32 USB pen drive 33 Standby mo...

Страница 12: ...e 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 t...

Страница 13: ...manual tank 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 acce...

Страница 14: ...ENG Rev12 2019 08 31 2019 W H Sterilization Srl 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 c...

Страница 15: ...9 W H Sterilization Srl 15 COMPONENTS BEHIND THE SERVICE DOOR Part Description A Mains switch B USBport C Emergency door opening tool D Identification label E Used water drain port grey F Clean water...

Страница 16: ...W H Med ENG Rev12 2019 08 31 2019 W H Sterilization Srl 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 C...

Страница 17: ...111 Instructions for Use MN 111 W H Med ENG Rev12 2019 08 31 2019 W H Sterilization Srl 17 CHAMBER ACCESSORIES Part Description A Tray B Chamber rack It can host trays or cassettes inserted horizonta...

Страница 18: ...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 ci...

Страница 19: ...SI 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 WATER TANKS...

Страница 20: ...ounds stop filling DRAINING THE USED AND CLEAN WATER TANKS Notice Before carrying out the following steps make sure that the sterilizer has completed the cycle in progress Always wear appropriate PPE...

Страница 21: ...TIONAL 1 Insert a standard Ethernet cable to in the LAN port of the sterilizer 2 Insert the other end of the cable in the LAN port of your computer or computer network when the sterilizer will be swit...

Страница 22: ...lizer on a sturdy flat and level surface 2 Remove all items from the sterilizer chamber except the chamber rack Remove all plastic covers from trays 3 Connect the auto fill and auto drain tubes in the...

Страница 23: ...sterilizer automatically turns in standby mode See Standby mode on page 34 3 Tap The homepage appears with the enabled sterilization cycles HOMEPAGE DESCRIPTION Part Description A Title purpose of th...

Страница 24: ...Getting started 24 MN 111 Instructions for Use MN 111 W H Med ENG Rev12 2019 08 31 2019 W H Sterilization Srl User interface menu STRUCTURE AND NAVIGATION optional with Activation code optional...

Страница 25: ...s to n monitor the performed cycle data n manage users n set the label printing options DEVICE SETTING MENU FUNCTIONS Icon Label Function Date Time Sets time and date values and format Display Sets th...

Страница 26: ...status Remote Folder 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...

Страница 27: ...Reset user PIN code Administrator only Resets a user PIN code Change your PIN code Changes the PIN code Options Optional activated with an activation code Administrator only Permits the following n id...

Страница 28: ...SETTING screen of a specificarea Shows the list of all operating parameters of the sterilizer Shows a sterilization summary Indicates the value that may be changed and appears by clicking on it Confi...

Страница 29: ...cates 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...

Страница 30: ...t 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...

Страница 31: ...es not connect automatically or if you are using a Wi Fi dongle key follow the following procedure under supervision of your IT manager network administrator 1 On the homepage tap 2 If the connection...

Страница 32: ...sses ask your IT manager for details Then tap to confirm User authentication optional FUNCTION AVAILABILITY To access the user management functions the User Management activation code must be entered...

Страница 33: ...en drive DESCRIPTION A USB pen drive is available to be installed in order to automatically record all the sterilization cycle reports The USB pen drive can be inserted equally into the front or rear...

Страница 34: ...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...

Страница 35: ...nstructions for Use MN 111 W H Med ENG Rev12 2019 08 31 2019 W H Sterilization Srl 35 Getting started CHANGING STANDBY MODE DELAY TIME 1 On the homepage tap 2 Tap or to change the delay time 3 Tap to...

Страница 36: ...t activation code must be entered The activation code is required only at the first access to the User Management or the Options menus after the code was entered the function is enabled and there is n...

Страница 37: ...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...

Страница 38: ...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...

Страница 39: ...is enabled and there is no need to enter the code again To acquire the activation code please refer to the Activation code instructions WHO CAN SET THE TRACEABILITY OPTIONS Only a user with administr...

Страница 40: ...IDE A CYCLE Only a user with administrator rights can hide a cycle or make it available to users on the homepage HIDE UNHIDE A CYCLE 1 On the homepage tap 2 Tap your user name 3 Enter your PIN and tap...

Страница 41: ...ic printer models available through manufacturer 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...

Страница 42: ...el 5 If the printout is not duly centered tap 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...

Страница 43: ...ected confirm the printer sharing 10 Tap again to print a test label Label printer usage optional CAUTION For your safety and the safety of your patients use a storage time compliant with the recommen...

Страница 44: ...matic 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 46 SET THE AUTOMATIC L...

Страница 45: ...1 2019 W H Sterilization Srl 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 1 On the homepage tap 2 Activ...

Страница 46: ...e 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 u...

Страница 47: ...y 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 i...

Страница 48: ...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 conta...

Страница 49: ...31 2019 W H Sterilization Srl 49 Sterilization cycles Typical loads EXAMPLES An example of a typical load used during the tests performed by W H is reported below Program Load example Wrapped Medium...

Страница 50: ...t 1 Open the chamber door and 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 vert...

Страница 51: ...set a different start time See Delay the sterilization cycle start on the next page 4 Tap the door locks If you have not set a different start time the cycle starts immediately 5 Tap to view the cycl...

Страница 52: ...ice hours You can set the cycle start date and time and enable or disable it for each cycle 1 On the homepage tap the cycle and 2 Tap Start cycle at 3 If you want to change the start time tap the time...

Страница 53: ...creased from the default value 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...

Страница 54: ...n 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 pa...

Страница 55: ...erile 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 prog...

Страница 56: ...r 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 U...

Страница 57: ...t 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...

Страница 58: ...rint 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...

Страница 59: ...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 followi...

Страница 60: ...ge 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...

Страница 61: ...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 cycle...

Страница 62: ...f 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 co...

Страница 63: ...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 tempe...

Страница 64: ...rsonnel 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 main...

Страница 65: ...ou 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 proc...

Страница 66: ...maintenance CLEANING THE DOOR GASKET AND THE CHAMBER FACE SIDE Proceed as follows 1 Clean the door gasket and the outer edge of the chamber with a non abrasive cloth moistened with clean water 2 Rins...

Страница 67: ...an 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...

Страница 68: ...oving 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 screw...

Страница 69: ...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 1 Op...

Страница 70: ...70 MN 111 Instructions for Use MN 111 W H Med ENG Rev12 2019 08 31 2019 W H Sterilization Srl 5 Insert the new seal and press first up and down 6 Press left and right 7 Make sure the door gasket is se...

Страница 71: ...otice 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 1 Open...

Страница 72: ...rilizer 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 T...

Страница 73: ...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 ru...

Страница 74: ...escription Actions 0xx Load cannot be considered sterile See End of a sterilization cycle on page 54 Repeat the cycle If the problem persists call service Check if the mains switch or network circuit...

Страница 75: ...er face side Check if the load placed in the sterilization chamber complies with the MAXIMUM WEIGHT LIMITS Clean the chamber and the chamber furniture from residuals of detergents disinfectants and ot...

Страница 76: ...service Drain and or refill the clean water tank Check the door gasket Clean or replace it if necessary 5xx Check if there are hurdles on the door locking area chamber rack loads objects Repeat the cy...

Страница 77: ...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 pr...

Страница 78: ...A Current sterilization cycle B Error number See Errors on page 74 C Warning messages D Open button that appears after the reset phase had finished WARNING MESSAGES Message Description Load not steri...

Страница 79: ...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...

Страница 80: ...er door gasket Clean or replace the door gasket Clean the chamber face side Internal leak Call technical service The cycle commences but there is no pressure temperature rise The safety thermostat swi...

Страница 81: ...nance and preparation on page 47 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...

Страница 82: ...cle 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 c...

Страница 83: ...isk CAUTION High temperature Risk of burns Carry out the following procedure only when the sterilizer has completely cooled down The sterilizer should be unplugged from the mains power supply for at l...

Страница 84: ...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 naturally decreased to the e...

Страница 85: ...uctions for Use MN 111 W H Med ENG Rev12 2019 08 31 2019 W H Sterilization Srl 85 6 Insert the opening tool into the hole and then turn it counterclockwise until the door is unlocked proceed slowly un...

Страница 86: ...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 cro...

Страница 87: ...50 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 3 30 minutes 3 60 minutes STERILIZATION PROGRAM OPTIONS 200 240 V AC VERSION WARNING The ster...

Страница 88: ...instruments and dental handpieces Yes Yes Yes Yes Yes Textiles No 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...

Страница 89: ...ing 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...

Страница 90: ...ycle During this 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 mus...

Страница 91: ...G Rev12 2019 08 31 2019 W H Sterilization Srl 91 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 dura...

Страница 92: ...2 MN 111 Instructions for Use MN 111 W H Med ENG Rev12 2019 08 31 2019 W H Sterilization Srl LOW TEMPERATURE PRESSURE PROFILE Low Temperature sterilization program features the following pressure prof...

Страница 93: ...1 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 temp...

Страница 94: ...DEMINERALIZED WATER Water quality See the Test instructions service book conductivity 10 S cm Total Dissolved Solids 6 5 ppm Average water consumption 0 17 to 0 2 gal cycle 0 65 to 0 75 litres cycle T...

Страница 95: ...N 111 Instructions for Use MN 111 W H Med ENG Rev12 2019 08 31 2019 W H Sterilization Srl 95 Diagrams CONNECTION DIAGRAMS Data communication Water system Note for water requirements see Water quality...

Страница 96: ...C Contaminants minerals qualities Value Specification Total Dissolved Solids 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...

Страница 97: ...sterilization 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...

Страница 98: ...ZER Picture Part Part number Standard chamber rack F523030X Aluminium tray x4 F523211X Tray holder F523001X Emergency door opening tool S520009X Drain tube S230903X Picture Part Part number Mains cabl...

Страница 99: ...e connection of the cycle report printer A801503X Label printer label printer only 19721109 Label printer connection kit n USBconnection cable n 1 roll of 2100 labels n 1 wax resin ribbon n activation...

Страница 100: ...tion Srl 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 w...

Страница 101: ...Sterilization Srl 101 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...

Страница 102: ...tions 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...

Страница 103: ...rilization 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...

Страница 104: ...c 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 Rev12 2019 08...

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