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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   be
transported   by   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.

Test connection.

Lexa PLUS | Instructions for Use | RIS-311 ENG Rev03 | 29/08/2022 | © W&H Sterilization Srl

Содержание Lexa PLUS

Страница 1: ...RIS 311 Instructions for Use RIS 311 ENG Rev03...

Страница 2: ......

Страница 3: ...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 optional 41 Lab...

Страница 4: ...nance 75 Disposal 76 Diagnostics 77 Errors 77 Troubleshooting 82 Emergency door opening 87 Technical data 90 Sterilization programs 90 Sterilization cycle phases 93 Technical data 97 Recommendations f...

Страница 5: ...ronic 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 elec...

Страница 6: ...ad 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 R...

Страница 7: ...ce 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...

Страница 8: ...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 ow...

Страница 9: ...ed for the sterilization in veterinary practices They are also intended to be used for materials and equipment which are likely to come into contact with blood or body fluids e g implements used by be...

Страница 10: ...Program Type of Load and Load weight Sterilization Temperature Sterilization Time Drying Time recommended Wrapped Pouched Instruments and Dental Handpieces on trays 14 lbs 6 3 kg trays excluded Instru...

Страница 11: ...dpieces up to 18 lbs 8 1 kg 270 F 132 C 4 minutes 4 minutes See Sterilization programs on page 90 for the full list of key program features including sterilization time temperature drying time and rec...

Страница 12: ...iquids 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: ...e 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...

Страница 14: ...elf 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 www wh com n Keep these Instruction...

Страница 15: ...8 Product description 19 Installing the sterilizer 23 Operating the sterilizer 27 User interface menu 28 Sterilizer setup 34 User authentication optional 35 EliTrace optional 36 USB pen drive 36 Stand...

Страница 16: ...n 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...

Страница 17: ...uctions for Use 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 wate...

Страница 18: ...TO RELOCATE THE STERILIZER Before transport n Completely drain both water tanks see Draining the used and clean water tank on page 75 n Allow the sterilization chamber to cool down n Use original pack...

Страница 19: ...t description FRONT VIEW Part Description A Chamber door B Clean water tank filling point C Door locking system D Touch screen E Service door F Sterilization chamber G Safety thermostat reset H HEPA f...

Страница 20: ...erilization 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 drai...

Страница 21: ...for Use RIS 311 ENG Rev03 29 08 2022 W H Sterilization Srl 21 REAR VIEW Part Description A LAN port B USB ports C Pressure safety valve cover D Used water drain E Water supply inlet F Condenser grid G...

Страница 22: ...ed 22 Lexa PLUS Instructions for Use RIS 311 ENG Rev03 29 08 2022 W H Sterilization Srl CHAMBER ACCESSORIES Part Description A Tray B Chamber rack It can host trays or cassettes inserted horizontally...

Страница 23: ...res The sterilizer must operate in a well 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...

Страница 24: ...tem WATER TANKS At every cycle the sterilizer uses new fresh 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...

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 45 gal 5 5 l min below the sterilizer and insert into it the free end...

Страница 26: ...call 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 99...

Страница 27: ...ick 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 St...

Страница 28: ...er management Traceability Opens the pages to n monitor the performed cycle data n manage users n set the label printing options Accessories Opens the pages to accessories management Maintenance Carri...

Страница 29: ...Icon Label Function IoDent Only if this service is supported in the country of use and if the sterilizer is connected to it Shows the status of the connection with the W H monitoring server Eliso Sta...

Страница 30: ...er PIN code Administrator only Resets a user PIN code Icon Label Function Change your PIN code Changes the PIN code Options Administrator only Permits the following n Identifies and saves the operator...

Страница 31: ...lizer The icon appears disabled if the printer Ethernet cable Wi Fi dongle key is not connected Special Codes Saves the codes issued by the manufacturer to activate special functions Note only for tec...

Страница 32: ...ING 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...

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 PLUS Instructions for Use RIS 311 ENG Rev03 29 08 20...

Страница 34: ...on the sterilizer screen SET THE LANGUAGE 1 On the homepage tap 2 Tap the language you prefer 3 Tap to confirm and go back to the homepage SET THE DATE AND TIME To change the date and time format curr...

Страница 35: ...our network supports dynamic IP addresses ask your IT manager enable the options Dynamic both in IP Configuration and in the DNS Configuration fields then tap to confirm all entry fields are disabled...

Страница 36: ...the first access to the EliTrace menus after the code was entered the function is enabled and there is no need to enter the code again If you want to disable the function another special code must be...

Страница 37: ...you have already saved your data on a safe support before formatting Standby mode DESCRIPTION When in Standby mode the sterilizer display remains dark and the sterilizer chamber is not heated to save...

Страница 38: ...to enter the code again If you want to disable the function another special code must be entered Note for more information contact your dealer WHO CAN MANAGE USERS AND RESET THEIR PIN Only a user wit...

Страница 39: ...VAILABILITY To access the user management functions a special code must be entered The special code is required only at the first access to the Options menus after the code was entered the function is...

Страница 40: ...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 to...

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

Страница 42: ...lly 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 whol...

Страница 43: ...lue 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: ...lease 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...

Страница 45: ...LIZER Test Purpose Reference Bowie and Dick test Validate the sterilizer performance for textile load sterilization See Bowie and Dick test below Vacuum test Validate the sterilizer performance in ter...

Страница 46: ...to the local Regulations and the instructions of the PCD manufacturer 1 Empty the sterilizer chamber to ensure no load is present Remove all trays from the sterilization chamber except the lowest one...

Страница 47: ...tructions of the PCD manufacturer Vacuum test CAUTION Follow local national guidelines on the frequency of testing Notice If a drainage period of the Unwrapped cycle is still operating wait the draina...

Страница 48: ...uum test 4 Tap and enter your credentials if required the chamber door locks 5 Wait until the end of the test and tap OPEN the chamber door unlocks 6 Enter your credentials if required a message infor...

Страница 49: ...ed and lubricated in accordance with the instrument manufacturer s instructions Notice Any residual of chemicals could seriously damage the sterilizer The manufacturer s warranty is void in case of da...

Страница 50: ...nd detergents Rinse and dry carefully all instruments The instruments and tubes must be carefully rinsed and dried prior to sterilization CORRECT LOAD PLACEMENT WARNING Do not overload trays and the c...

Страница 51: ...from different materials stainless steel carbon steel aluminium etc On separate trays or wrapped pouched Instruments manufactured from carbon steel Place paper among them and the trays to avoid rusty...

Страница 52: ...ter tank with distilled or demineralized water until the sterilizer makes a sound See Technical data on page 97 for the tank volume INSERTING THE CHAMBER RACK INTO THE STERILIZER CAUTION Risk of burns...

Страница 53: ...y program features including sterilization time temperature and recommended load type AVAILABLE ECO DRY MODES Icon Mode Description ECO DRY plus The drying time is automatically adjusted to the shorte...

Страница 54: ...RY mode see Change the ECO DRY mode on page 57 n to disable the ECO DRY mode see Set the drying time on page 57 5 If the door gasket is new hold the door gently closed until the beginning of the cycle...

Страница 55: ...n of the cycle US Canada version 270 F 132 C cycles 250 F 121 C cycles Duration minutes 4 30 Min temperature 270 F 132 C 250 F 121 C Max temperature 275 F 135 C 255 F 124 C 270 F 132 C cycles 250 F 12...

Страница 56: ...ALLY It is possible to program the sterilizer in such a way that a sequence of cycles runs automatically at a preset date and time e g if you want to run a vacuum test in the early morning before offi...

Страница 57: ...fixed value CHANGE THE ECO DRY MODE 1 On the homepage tap the cycle and 2 Tap the leaf icon to set the ECO DRY mode 3 Tap the ECO DRY mode you desire 4 Tap to confirm and go back to the previous page...

Страница 58: ...to 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 occur...

Страница 59: ...pecific remote folder in the network if the sterilizer is connected to a LAN STORED REPORT FORMAT The summarized reports are stored in HTML format and the analytical reports in SCL format All paramete...

Страница 60: ...terilization cycle reports are stored in the USB SET THE REMOTE FOLDER FOR SAVING THE REPORTS To activate the remote storage and set the necessary parameters do the following 1 On the homepage tap 2 T...

Страница 61: ...erformed 3 In case a test fails check the relevant settings and tap to repeat the test sequence if the error persists call your IT manager 4 Tap to go back to the previous page SAVE ALL THE CYCLE REPO...

Страница 62: ...le Name of the executed cycle Number Cycle counter Sterilizat temp Programmed sterilization temperature Sterilizat time Programmed Plateau Sterilization Date above Cycle start date and time START Cycl...

Страница 63: ...03 29 08 2022 W H Sterilization Srl 63 Sterilization cycles Data Description Cycle end at Cycle end date and time Cycle time Cycle time Signature Operator signature Cycle completed Cycle outcome Track...

Страница 64: ...to 1500 lx 15 lx Before making any operation ward off unauthorized personnel from the working area CAUTION Before accessing the chamber and the connected parts be sure that the sterilizer is cold Not...

Страница 65: ...displayed Please check that 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 If you can n...

Страница 66: ...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 Notice Do not use abrasive products cutting...

Страница 67: ...e 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 chamb...

Страница 68: ...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 a...

Страница 69: ...laced every 400 sterilization 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...

Страница 70: ...ing the water tank below 2 Access to the water tank on the next page Access to the water tank on the next page 3 Clean the water tank on page 72 PREPARE THE STERILIZER FOR CLEANING THE WATER TANK Proc...

Страница 71: ...Maintenance Lexa PLUS Instructions for Use RIS 311 ENG Rev03 29 08 2022 W H Sterilization Srl 71 ACCESS TO THE WATER TANK Proceed as follows 1 Lift the water tank cover...

Страница 72: ...or better cleaning results clean with W H MC 1000 cleaning solution Use a small non abrasive brush to clean the areas that are difficult to reach Notice never use any other disinfectant detergent or a...

Страница 73: ...o be replaced every 1200 sterilization 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 r...

Страница 74: ...ance 74 Lexa PLUS Instructions for Use RIS 311 ENG Rev03 29 08 2022 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 75: ...at least seven days you have to drain the tanks 1 Open the sterilizer service door 2 Put a container below the sterilizer 1 45 gal 5 5 l minimum and place the end of the drain tube in it 3 To drain th...

Страница 76: ...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 i...

Страница 77: ...e Code Description Actions 0xx Load cannot be considered sterile See End of a sterilization cycle on page 58 Repeat the cycle If the problem persists call service Check if the mains switch or network...

Страница 78: ...itch the sterilizer OFF and ON Clean the door gasket and the chamber face side Check if the load placed in the sterilization chamber complies with the MAXIMUM WEIGHT LIMITS Clean the chamber and the c...

Страница 79: ...y 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 5...

Страница 80: ...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 81: ...ou 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 d...

Страница 82: ...when opening the door prevent spilling e g place a towel below the chamber door VIEW AND SAVE THE ERROR LOG 1 Tap to save the list in the USB pen drive ERROR PAGE During the sterilization cycle the s...

Страница 83: ...st 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...

Страница 84: ...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 85: ...enance and preparation on page 49 Scale deposits on the chamber Clean the chamber and use water of good quality See Water quality on page 100 Instruments are turning brown or black Incorrect temperatu...

Страница 86: ...ycle 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...

Страница 87: ...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 88: ...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...

Страница 89: ...xa PLUS Instructions for Use RIS 311 ENG Rev03 29 08 2022 W H Sterilization Srl 89 6 Insert the opening tool into the hole and then turn it counterclockwise until the door is unlocked proceed slowly u...

Страница 90: ...e 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 i...

Страница 91: ...tes 30 60 minutes Custom B 1 270 F 132 C 4 30 minutes 3 60 minutes Custom C 1 273 F 134 C 3 30 minutes 3 60 minutes 1 This is a profile defined by ANSI AAMI ST55 as a dynamic air removal steam flush p...

Страница 92: ...load except porous textile Maximum load weight Pouched unwrapped items on trays 14 lbs 6 3 kg 3 Items in wrapped unwrapped cassettes or in trays and wrapped unwrapped cassettes 16 5 lbs 7 5 kg 4 Pouc...

Страница 93: ...g of the sterilizer This phase is not considered a part of the cycle PV1 PV3 PV1 PV6 Vacuum pulse removal of air from the sterilizer chamber load PP1 PP2 PP1 PP5 Pressure pulse steam generation PPH Ri...

Страница 94: ...for Use RIS 311 ENG Rev03 29 08 2022 W H Sterilization Srl TYPE B STERILIZATION CYCLE PHASES The type B sterilization cycles feature different pressure profile duration and temperature of the steriliz...

Страница 95: ...Technical data Lexa PLUS Instructions for Use RIS 311 ENG Rev03 29 08 2022 W H Sterilization Srl 95...

Страница 96: ...2 W H Sterilization Srl TYPE S STERILIZATION CYCLE PHASES The S cycle is specifically designed to sterilize unwrapped instruments for immediate use on patients not requiring a complete drying Thus the...

Страница 97: ...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...

Страница 98: ...Dissolved Solids 6 5 ppm Average water consumption 0 07 to 0 23 gal cycle 0 26 to 0 85 litres cycle Tank volume Clean water 1 27 gal 4 8 l Min water charge 0 22 gal 0 82 l Used water 1 35 gal 5 11 l...

Страница 99: ...data Lexa PLUS Instructions for Use RIS 311 ENG Rev03 29 08 2022 W H Sterilization Srl 99 Diagrams CONNECTION DIAGRAMS Data communication Water system for water requirements see Water quality on the...

Страница 100: ...es mg L 250 1 Bacteria cfu mL n a 105 10 Endotoxin EU mL n a 205 10 Note 1 This is the quality of water that might come from the tap but might need some form of treatment to achieve these specificatio...

Страница 101: ...ation process and damage the sterilizer The use of water with a conductivity greater than 50 S cm or not complying with the specifications in the table above may strongly affect the sterilization proc...

Страница 102: ...rt Part number Standard chamber rack F523037X Optional chamber rack for 3 trays 3 taller cassettes or 4 standard cassettes Usable space Tray Cassette size mm n 207 x 48 x 48 F523036X Aluminium tray 22...

Страница 103: ...ls n 2 wax resin ribbons A810513X Roll of thermal paper A810504X QR code Bar code reader for labels 19721132 Multidem C27 water demineralizer 19723112 Multidem resin cartridge A812016X Picture Part Pa...

Страница 104: ...PLUS Instructions for Use RIS 311 ENG Rev03 29 08 2022 W H Sterilization Srl Technical data Authorized W H service partners A list and a map with your nearest W H service partner are available at www...

Страница 105: ...he Instructions for Use 7 Were all 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...

Страница 106: ...you shown the head of the clinic practice the advantages of having a connection remote data saving Yes No 23 Have you explained to the head of the clinic practice the correct load type for each avail...

Страница 107: ...Sterilization Srl 107 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 623...

Страница 108: ...W H Sterilization Srl via Bolgara 2 Brusaporto BG Italy www wh com 39 035 66 63 000 RIS 311 Instructions for Use ENG Rev03 29 08 2022 Subject to changes...

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