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Storage

Transportation

Medical Device

Only for MDR devices

Serial Number

Catalogue number

Max.

pressure

Max.

allowable working pressure
(MAWP)

Temperature between XX °C
and XX °C

Manufacturing date (YYYY-
MM-DD)

Country of manufacture

Manufacturer

Unique Device Identification

Health Industry Bar Code in
accordance

with

HIBC

Standard

Small Steam Sterilizer

This side up

Fragile, handle with care

Keep dry

The

sterilizer

must

transported

two

authorized technicians due
to its heavy weight

ON (supply) IEC 60417-
5007

OFF (supply) IEC 60417-
5008

IN-position of bistable push
control IEC 60417-5268

OUT- position of bistable
push control IEC 60417-
5269

USB connection

GS1 datamatrix for logistic
purpose

Sterilizer type or model

Test connection

Lexa | Instructions for Use | MN-111 Med ENG Rev14 | 03/04/2023 | © W&H Sterilization Srl

Содержание MN-111

Страница 1: ...MN 111 Instructions for Use MN 111 Med ENG Rev14...

Страница 2: ......

Страница 3: ...Standby mode 37 Administrator 38 User management optional 38 Traceability options optional 39 Hide Unhide a cycle 40 Managing printers 41 Printer selection optional 41 Label printer selection optiona...

Страница 4: ...opening 78 Technical data 81 Sterilization programs 81 Sterilization program phases 86 Technical data 90 Recommendations for validation 91 Diagrams 92 Water quality 93 Accessories spare parts consuma...

Страница 5: ...nic Equipment Directive WEEE CSA C22 2 No 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use general requirements UL 61010 1 Safety requirements for electr...

Страница 6: ...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 Ris...

Страница 7: ...with HIBC Standard Small Steam Sterilizer This side up Fragile handle with care Keep dry The sterilizer must be transported by two authorized technicians due to its heavy weight ON supply IEC 60417 50...

Страница 8: ...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...

Страница 9: ...egulation EU 2017 745 The small steam sterilizers are intended for the sterilization of devices other than invasive and non invasive medical ones The small steam sterilizers are intended for the steri...

Страница 10: ...6 lbs 2 7 kg 270 F 132 C 4 minutes 30 minutes Wrapped Cassettes Instruments and dental handpieces up to 14 lbs 6 3 kg 270 F 132 C 4 minutes 40 minutes Program Type of Load and Load weight Sterilizati...

Страница 11: ...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...

Страница 12: ...quids 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...

Страница 13: ...and not sensible related to patients To further protect the device and minimize successful cyber attacks the following precautions have been taken n the access to the device operating system is not po...

Страница 14: ...lf is not installed used and serviced in accordance with these Instructions for Use n The Instructions for Use updated to the latest version is always available at med wh com n Keep these Instructions...

Страница 15: ...ling 18 Product description 19 Installing the sterilizer 23 Operating the sterilizer 27 User interface menu 28 Sterilizer setup 34 ioDent 35 User authentication optional 35 USB pen drive 36 Standby mo...

Страница 16: ...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 packagin...

Страница 17: ...se This manual declaration of conformity warranty card work test report ITEMS NOT PROVIDED WITH THE STERILIZER The following items are not provided n Water container to capture waste water during manu...

Страница 18: ...O RELOCATE THE STERILIZER Before transport n Completely drain both water tanks see Draining the used and clean water tank on page 66 n Allow the sterilization chamber to cool down n Use original packa...

Страница 19: ...G Rev14 03 04 2023 W H Sterilization Srl 19 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 chambe...

Страница 20: ...rilization Srl COMPONENTS BEHIND THE SERVICE DOOR Part Description A Mains switch B USB port C Emergency door opening tool D Identification label E Used water drain connection grey F Clean water drain...

Страница 21: ...Med ENG Rev14 03 04 2023 W H Sterilization Srl 21 REAR VIEW Part Description A LAN port KIT B USB port C Pressure safety valve cover D Used water drain optional E Water supply inlet optional F Conden...

Страница 22: ...ted 22 Lexa Instructions for Use MN 111 Med ENG Rev14 03 04 2023 W H Sterilization Srl CHAMBER ACCESSORIES Part Description A Tray B Chamber rack It can host trays or cassettes inserted horizontally o...

Страница 23: ...ventilated room indoor 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 CONNEC...

Страница 24: ...water and at the end of the cycle discharges it Thus the sterilizer is fitted with two water tanks the clean water tank and the used water tank For this reason is necessary to periodically fill the cl...

Страница 25: ...er tank is almost full an alert appears on the display 2 Open the service door at the front of the sterilizer 3 Put a container 1 84 gal 7 l min below the sterilizer and insert into it the free end of...

Страница 26: ...for service Do not attempt to repair the sterilizer by yourself Notice Please ensure that all installation requirements are met before plugging the sterilizer See Connection diagrams on page 92 No ot...

Страница 27: ...ck autotest the sterilizer automatically turns in Standby mode See Standby mode on page 37 Note at the first start up of the sterilizer the Guided Configuration procedure automatically appears see Ste...

Страница 28: ...performed cycle data n manage users n set the label printing options Accessories Opens the pages to accessories management Maintenance Carries out the maintenance procedure DEVICE SETTINGS MENU FUNCT...

Страница 29: ...e country of use and if the sterilizer is connected to it Shows the status of the connection with the W H monitoring server Akidata status Icon Label Function Remote Data Storage Only with a network c...

Страница 30: ...ng n Identifies and saves the operator who starts the cycle and releases the load n Protects with a password the cycle start the cycle stop and the load release Icon Label Function EliTrace Allows to...

Страница 31: ...issued by the manufacturer to activate special functions Note only for technical support MAINTENANCE MENU FUNCTIONS Icon Label Function Bact Filter n Shows the status of the consumables n Resets the...

Страница 32: ...NG screen of a specific area 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 Confirms t...

Страница 33: ...Indicates that the option is active not active Indicates that the option is enabled disabled Show an animation about the replacement procedure Lexa Instructions for Use MN 111 Med ENG Rev14 03 04 202...

Страница 34: ...time and time zone 1 On the homepage tap 2 Tap the value you want to change format time date and or time zone 3 Tap the desired value 4 Tap to confirm and go back to the previous page SET THE STERILI...

Страница 35: ...rm all entry fields are disabled 5 If your network does not support dynamic IP addresses ask your IT manager enable the options Static both in IP Configuration and in the DNS Configuration fields Tap...

Страница 36: ...ack to the previous page WHAT TO DO IF YOU FORGET YOUR PIN If Then you are a common user contact the administrator you are the administrator contact your authorized service provider USB pen drive DESC...

Страница 37: ...he 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 STA...

Страница 38: ...unction 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 MANAGE USERS AND RESET THEIR PIN Only a user wit...

Страница 39: ...ILITY To access 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 a...

Страница 40: ...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 to c...

Страница 41: ...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 The first time you access the Label...

Страница 42: ...ly connected is ON and no cycle is running 2 From that sterilizer tap 3 Depending on the LAN connection take note of the Ethernet or Wi Fi IP address 4 Do not switch OFF the sterilizer until the whole...

Страница 43: ...ue is used to calculate the expiry date to be printed on the labels see Label content description on the next page SET THE AUTOMATIC LABEL PRINTING 1 On the homepage tap 2 Activate Automatic printing...

Страница 44: ...ease 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 w...

Страница 45: ...seriously damage the sterilizer The manufacturer s warranty is void in case of damage caused by chemicals CLEANING THE INSTRUMENTS Clean all instruments thoroughly prior to sterilization If possible c...

Страница 46: ...e them in the lowest rack position as there is more space height wise Pouched items On trays allowing adequate space in between bags Ensure that packs do not touch the walls of the chamber Place steri...

Страница 47: ...If no water system is connected you have to fill the tank 1 Switch the sterilizer ON and open the chamber door 2 Fill the clean water tank with distilled or demineralized water until the sterilizer ma...

Страница 48: ...paper side of the sterilization bags faces up and that the space in between bags is enough n To enjoy the full benefit of short cycle times when only one tray is used always place the load on the uppe...

Страница 49: ...Note the user visually checks that pouches are intact and dry It is even possible to identify the user who releases the load accepts the cycle plateau time cycle minimum temperature and cycle minimum...

Страница 50: ...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 or the date a...

Страница 51: ...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 information page ope...

Страница 52: ...o remove the load 3 Open the chamber door 4 Remove the load and stock it STOP A STERILIZATION CYCLE WARNING You can stop the cycle at any time Instruments must not be considered sterile if this occurs...

Страница 53: ...rts can also be saved on the USB pen drive or in a specific remote folder in the network if the sterilizer is connected to a LAN optional A minimum of 10000 cycles are storable in the provided USB STO...

Страница 54: ...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 5 Tap or to inc...

Страница 55: ...on credentials to access the remote storage folder and enter the user name and password 7 Tap to save 8 Tap to go back to the previous page 9 To check if the parameters entered are valid see Test the...

Страница 56: ...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 conditio...

Страница 57: ...See Sterilization program phases on page 86 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 C...

Страница 58: ...nnel 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 mainten...

Страница 59: ...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...

Страница 60: ...ND 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 Notice do not use abrasive products cutting t...

Страница 61: ...nge 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 spong...

Страница 62: ...ater 5 Insert the filters in their original position screwing them into place Note tap to see the animated cleaning procedure CLEANING THE EXTERNAL SURFACES OF THE STERILIZER Proceed as follows 1 Clea...

Страница 63: ...erilization cycles or once a year whichever come first A replacement message alerts when replacement is due If the consumables is replaced prior to the message you have to reset the consumable cycle c...

Страница 64: ...nance 64 Lexa Instructions for Use MN 111 Med ENG Rev14 03 04 2023 W H Sterilization Srl 4 Insert the new seal and press first up and down 5 Press left and right 6 Make sure the door gasket is seated...

Страница 65: ...or once a year whichever come first A replacement message alerts when replacement is due If the consumables is replaced prior to the message you have to reset the consumable cycle counter Proceed as f...

Страница 66: ...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...

Страница 67: ...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...

Страница 68: ...iption Actions 0xx Load cannot be considered sterile See End of a sterilization cycle on page 52 Repeat the cycle If the problem persists contact technical service Check if the mains switch or network...

Страница 69: ...e 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 other ch...

Страница 70: ...ce 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 cycle I...

Страница 71: ...u may run a cycle but the water must be replaced soon otherwise the unit will automatically lock out to prevent damage Poor water quality detected Replace with higher quality water or equipment damage...

Страница 72: ...you replaced the door gasket Press YES to reset the counter Have you replaced the HEPA filter Press YES to reset the counter HEPA Filter replacement is due Do you want to replace it now Possible leak...

Страница 73: ...t 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 During th...

Страница 74: ...be reset manually Proceed as follows 1 Switch the sterilizer OFF and remove the mains cable 2 Wait for the sterilizer to cool down 3 Open the sterilizer door 4 Unscrew the cap and push on the reset bu...

Страница 75: ...oor gasket Clean or replace the door gasket Clean the chamber face side Internal leak Contact technical service The cycle commences but there is no pressure temperature rise The safety thermostat swit...

Страница 76: ...nance and preparation on page 45 Scale deposits on the chamber Clean the chamber and use water of good quality See Water quality on page 93 Instruments are turning brown or black Incorrect temperature...

Страница 77: ...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 clogg...

Страница 78: ...risk 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...

Страница 79: ...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 80: ...0 Lexa Instructions for Use MN 111 Med ENG Rev14 03 04 2023 W H Sterilization Srl 6 Insert the opening tool into the hole and then turn it counterclockwise until the door is unlocked proceed slowly un...

Страница 81: ...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 inf...

Страница 82: ...dpieces Wrapped XL Load Wrapped Cassettes Instruments and dental handpieces up to 14 lbs 6 3 kg Pouches wrapped unwrapped and naked 270 F 132 C 4 wrapped Hygiene cassettes 8 x 5 5 20 3 mm x 13 8 mm 2...

Страница 83: ...minutes 3 60 minutes 1 these are profiles defined by ANSI AAMI ST55 as dynamic air removal steam flush pressure pulse These profiles can be enabled by the user Some of the parameters can be adjusted b...

Страница 84: ...4 4 4 4 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 lo...

Страница 85: ...ure 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 Dynamic air removal SFPP Dynamic air removal SFPP Dynamic...

Страница 86: ...actors Sterilization program phases LEGEND OF THE STERILIZATION PROGRAM PHASES Following is the description of the sterilization phases Code Phase Description PHE Pre heating phase Pre heating of the...

Страница 87: ...tion temperature band a restart process procedure is automatically executed by the sterilizer according to ST55 The sterilizer controls the sterilization condition through steam generation The steam g...

Страница 88: ...ENG Rev14 03 04 2023 W H Sterilization Srl 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 o...

Страница 89: ...data Lexa Instructions for Use MN 111 Med ENG Rev14 03 04 2023 W H Sterilization Srl 89 LOW TEMPERATURE PRESSURE PROFILE Low Temperature sterilization program features the following pressure profile 2...

Страница 90: ...00 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 temperatur...

Страница 91: ...olved 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 water charge clean water 0 29 gal 1 1 l Used water 1 77 gal 6 7...

Страница 92: ...l data 92 Lexa Instructions for Use MN 111 Med ENG Rev14 03 04 2023 W H Sterilization Srl Diagrams CONNECTION DIAGRAMS Data communication Water system for water requirements see Water quality on the n...

Страница 93: ...rilization 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 h...

Страница 94: ...ure Part Part number Standard chamber rack F523030X Large aluminium tray F523211X Tray holder F523001X Emergency door opening tool S520009X Picture Part Part number Drain tube S230903X Mains cable 125...

Страница 95: ...n 2 rolls of 2100 labels n 2 wax resin ribbons A810513X Roll of thermal paper A810504X QR code Bar code reader for labels 19721132 Multidem C27 water demineralizer 19723112 Picture Part Part number Mu...

Страница 96: ...Auto fill kit with valve X051302X Auto fill kit with pump 110 V Auto fill kit with pump 220 V X051303X X051304X Auto drain kit X051331X LAN cable kit X051301X USB Ethernet socket hub assembly X051337X...

Страница 97: ...l sections 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...

Страница 98: ...the clinic practice the advantages of having a Ethernet connection remote data saving Yes No 22 Have you explained to the Head personnel of the clinic practice the correct load type for each available...

Страница 99: ...terilization Srl 99 Documentation forms ADDRESSES FOR SENDING THE INSTALLATION CHECK LIST Send a copy of the installation check list duly filled in to both of the following addresses Fax 43 6274 6236...

Страница 100: ...W H Sterilization Srl via Bolgara 2 Brusaporto BG Italy med wh com 39 035 66 63 000 MN 111 Med Instructions for Use ENG Rev14 03 04 2023 Subject to changes...

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