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Summary of Contents for W&H lexa RIS-303
- Page 1 Instructions for Use RIS-303 RIS-305 RIS-303 RIS-305 - ENG - Rev01...
- Page 3 Table of contents Conformity Traceability options (optional) Symbols and messages Hide/Unhide a cycle Introduction Managing printers About this manual Printer selection (optional) Use restrictions Label printer selection (optional) Label printer usage (optional) Safety information Safety warnings Label content description Responsibility Sterilizer tests Getting started Sterilizer performance tests...
- Page 4 800-cycle or yearly maintenance Extraordinary maintenance Disposal Diagnostics Errors Troubleshooting Emergency door opening Technical data Sterilization programs Sterilization cycle phases Technical data Recommendations for validation Diagrams Water quality Accessories, spare parts, consumables Authorized W&H service partners Documentation forms W&H installation check-list Lexa MINI ...
- Page 5 Conformity CONFORMITY TO EUROPEAN AND AMERICAN REGULATIONS, Standards STANDARDS AND DIRECTIVES Description Directives Sterilizer was developed according to the following Regulations, Standards and Directives: Table-top steam sterilizers ANSI/AAMI ST55 Standards IEC 61010-1 Safety requirements for electrical equipment for measurement, Description control and laboratory use, general requirements Directives IEC 61010-2-...
- Page 6 Symbols and messages SAFETY SYMBOLS USED IN THIS MANUAL WARNING: indicates a hazardous situation that, if not avoided, could CAUTION: indicates a hazardous situation that, if not avoided, could result in death or serious injury. result in minor or moderate injury. Related to a sterilizer, these warnings indicate hazardous situations that could result in non-sterile conditions (e.g.
- Page 7 Storage Manufacturer USB connection GS1 datamatrix for logistic Transportation purpose Unique Device Identification Sterilizer type or model Medical Device Only for MDR devices Health Industry Bar Code in Test connection accordance with HIBC Serial Number Standard Small Steam Sterilizer Catalogue number This way up Max.
- Page 8 Introduction Contact customer service in the event the manual is unavailable. If CONTENTS the device is transferred, always attach the manual for the new This section deals with the following subjects: owner. About this manual MANUAL CONTENT Use restrictions This manual contains the Instructions for Use and for maintenance of the following sterilizer versions: RIS-303/RIS-305 100–125 V ac About this manual...
- Page 9 Introduction All drawings, images and texts contained in this manual are the For North American market: property of the manufacturer. Even partial duplication of drawings, Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam images or text is prohibited. sterilizer intended for use by a healthcare provider to sterilize The information contained in this document is subject to change medical products by means of pressurized steam.
- Page 10 Introduction Key program features, including sterilization time, temperature and Drying Type of Load and Load Steriliz. Steriliz. recommended load type are listed in the following table: Program Time weight Temp. Time (recom.) Drying Type of Load and Load Steriliz. Steriliz. All types of load; ...
- Page 11 Introduction USER QUALIFICATION The users who may operate the sterilizer are the following. User Competences qualification Head of the Legally responsible for: the efficiency of the hygiene protocol in place clinic/practice the sterilization process the operators' training and training documentation the correct operation and maintenance of the equipment Trained Regularly attend the training for operating and using the...
- Page 12 Safety information CONTENTS ELECTRICAL RISKS This section deals with the following subjects: Do not pour water or any other liquids over the sterilizer (risk of electrical short circuits). Safety warnings Switch off the sterilizer and unplug the mains Responsibility cable before inspecting, carrying out maintenance or servicing the sterilizer.
- Page 13 Safety information mass storage device, such as a pen drive, for cycle report TAMPERING saving; Do not remove the name plate or labels from mass storage device, such as a pen drive, for software the sterilizer. update; Repairs, maintenance or service must be report printer label printer carried out by authorized service providers...
- Page 14 Safety information Don't access the device web server functionality through A secure communication (with authentication and authorization) can links in e-mails. be established between the device and the cloud server for the Ensure the mail service provider has a spam filter. following functionalities: remote software update;...
- Page 15 Safety information frozen screen; The Instructions for Use updated to the latest version is always black screen; available at www.wh.com. significant slowdown when navigating the menus; Keep these Instructions for Use for future reference. malfunctioning or blocked network services (such as: remote data storage, label printer sharing, etc...).
- Page 16 Getting started CONTENTS Unpacking This section deals with the following subjects: Unpacking Handling Product description Installing the sterilizer Operating the sterilizer User interface menu Sterilizer setup ioDent User authentication (optional) EliTrace (optional) USB pen drive Standby mode Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 17 Getting started agent that has carried out the transport. Keep the packaging for UNPACK THE STERILIZER shipping or transporting the sterilizer in the future. CAUTION! Heavy product. The sterilizer must be removed Note: the packaging of the product is environmentally friendly and can be from the box and transported by two authorized technicians.
- Page 18 Getting started CONTENTS OF THE PACKAGING Drain tube Emergency door opening tool Sterilizer Trays (two) Tray holder Power cord Tube for drain connection Compressed air tube (only for Lexa MINI equipped with ejector) Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 19 Getting started Handling HOW TO RELOCATE THE STERILIZER Before transport: Completely drain both water tanks (see "Draining the clean water tank" on page 72). Allow the sterilization chamber to cool down. Use original packaging when shipping or transporting the USB pen drive loaded with This manual, declaration of sterilizer.
- Page 20 Getting started Product description FRONT VIEW Part Description Chamber door Clean water tank Door locking system Touch screen Service door Sterilization chamber Door gasket Water filling cover Tank venting cap Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 21 Getting started COMPONENTS BEHIND THE SERVICE DOOR Part Description Mains switch USB port Identification label Clean water drain connection (blue) Drain tube release button Port for emergency door opening tool Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 22 Getting started REAR VIEW Part Description LAN port USB ports Pressure safety valve ring Water supply inlet Condensate drain in external tank Condenser grid Power cord socket Used water drain Compressed air connection (only for Lexa MINI equipped with ejector) Air filter (only for Lexa MINI equipped with vacuum pump) HEPA Filter External used water tank connection...
- Page 23 Getting started CHAMBER ACCESSORIES Part Description Upper tray Lower tray Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 24 Getting started Installing the sterilizer AIR CONVEYOR INSTALLATION (OPTIONAL) If you need to install the sterilizer into a cabinet or into a confined space (see image below) it is necessary to install the air conveyor LOCATION REQUIREMENTS (optional). Notice: Place the sterilizer on a flat surface. Do not place the sterilizer so that it is difficult to operate the controls behind the service door.
- Page 25 Getting started The installation of the sterilizer shall be performed by two authorized LAN CONNECTION technicians using PPE (Personal Protective Equipment) according to applicable standards. The electrical power supply of the sterilizer must fulfill all applicable standards in the country of use, and must comply with the data label on the back of the sterilizer.
- Page 26 Getting started Connect the power cord to a wall outlet. For power supply INSTALLING THE STERILIZER requirements, see "Technical data" on page 95. WARNING! In case of sterilizer malfunctions immediately Connect the compressed air tube (Ø 6 mm) in the rear of the unplug the sterilizer and call for service.
- Page 27 Getting started After a quick autotest the sterilizer automatically turns in Standby mode. See "Standby mode" on page 38. Note: at the first start-up of the sterilizer, the Guided Configuration procedure automatically appears; see "Sterilizer setup" on page 34. . The homepage appears with the enabled sterilization cycles.
- Page 28 Getting started User interface menu DEVICE SETTINGS MENU FUNCTIONS Icon Label Function MAIN MENU FUNCTIONS Device Opens the pages to set the device. Note: this section describes some functions that might not be available on this product. Language Sets device language. Icon Label Function...
- Page 29 Getting started Icon Label Function Icon Label Function Cycle Exclusion Remote Data Sets the cycles menu. Only with a network connection set. Opens the page Storage to manage the remote storage. Settings Measurement Only with a network connection set. Sets the Sets the unit of measure (temperature, water Units parameters of the network location.
- Page 30 Getting started TRACEABILITY MENU FUNCTIONS Icon Function Label Icon Function Label EliTrace Allows to manage the instrument database. Cycle History Shows all the sterilization cycles and tests and prints reports and labels. Optional, activated with an activation code. Label Printer Enables/disables the printing of the labels.
- Page 31 Getting started Icon Label Function Icon Label Function Calibration Adjusts the label printer to the edge of the label. Chamber Shows the status of the cleaning operations. Resets the cycle counter. Cleaning Displays the cleaning procedure videos. Tank Test Prints a test label. Cleaning Installs and upload the software.
- Page 32 Getting started COMMON COMMANDS AND ICONS Icon Function Icon Function Icon Function Gives information about the current Aborts the action/function. Moves to the previous screen function. Enters/exits the standby mode. without confirming/making any changes nor saving any parameters. Moves to the previous/next screen. Indicates that the option is ON and Opens the homepage.
- Page 33 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. Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 34 Getting started Sterilizer setup SET THE DATE AND TIME To change the date and time format, current date and time and time zone: GUIDED CONFIGURATION At the first start- up of the sterilizer, the Guided Configuration On the homepage, tap >...
- Page 35 Getting started On the homepage, tap > > > SET THE DISPLAY BRIGHTNESS To change the display brightness: If the connection is through the Ethernet cable, tap : the TCP/IP screen appears. On the homepage, tap > > If the connection is through Wi-Fi dongle key, tap : after a to change the value.
- Page 36 Getting started ioDent 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 DESCRIPTION “0000” is reassigned. It allows to save the data securely and automatically on the cloud and it ensures intelligent and networked reprocessing of CHANGE YOUR PIN instruments, with a wide selection of smart solutions and options.
- Page 37 Getting started EliTrace (optional) USB pen drive FUNCTION AVAILABILITY DESCRIPTION To access the EliTrace functions a special code must be entered. The 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 special code is required only at the first access to the EliTrace( menus: after the code was entered, the function is enabled and inserted equally into the front or rear port.
- Page 38 Getting started Standby mode 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 Homepage EXIT THE STANDBY MODE or open or close the chamber door.
- Page 39 Administrator CONTENTS ADD A USER This section deals with the following subjects: On the homepage, tap > > > User management (optional) Tap your user name. Traceability options (optional) Enter the PIN and tap to confirm. Hide/Unhide a cycle Tap the text box: a keyboard appears. User management (optional) Enter the new user name and tap to confirm.
- Page 40 Administrator Traceability options (optional) DELETE A USER On the homepage, tap > > > To access the user management functions a special code must be Tap your user name. entered. The special code is required only at the first access to the Options ( ) menus: after the code was entered, the function is Enter the PIN and tap...
- Page 41 Administrator Hide/Unhide a cycle WHO CAN HIDE/UNHIDE 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 On the homepage tap > > > Tap your user name. Enter your PIN and tap to confirm.
- Page 42 Managing printers CONTENTS Label printer selection (optional) This section deals with the following subjects: FUNCTION AVAILABILITY Printer selection (optional) The first time you access the Label Printer ( ) menu, you will be Label printer selection (optional) requested to enter an activaction code. To require the activation Label printer usage (optional) code, please refer to the activation code instructions provided with Label content description...
- Page 43 Managing printers Depending on the LAN connection, take note of the Ethernet or SELECT AND CALIBRATE A LOCAL LABEL PRINTER Wi-Fi IP address. On the homepage, tap > > > Do not switch OFF the sterilizer until the whole procedure is : ...
- Page 44 Managing printers if required) and the load has been checked and released, if these DISABLE THE LABEL PRINTING options have been enabled by the administrator. If the label printing is disabled, no label can be printed at the end of a sterilization cycle.
- Page 45 Managing printers Label content description STRUCTURE Part Description Sterilizer model Serial number Software release Traceability code (alphanumerical and bar code) Depending on the traceability settings, this field may contain one of the Released following elements: the user who released the cycle the user who started the cycle the sterilizer ID Cycle...
- Page 46 Sterilizer tests CONTENTS This section deals with the following subjects: Sterilizer performance tests Bowie and Dick test Vacuum test Sterilizer performance tests TESTS THAT CAN BE PERFORMED ON THE STERILIZER Test Purpose Reference Bowie and Dick test Validate the sterilizer performance for textile load sterilization. See "Bowie and Dick test"...
- Page 47 Sterilizer tests Bowie and Dick test CAUTION! Follow local/national guidelines on the frequency of testing. PURPOSE OF THE TEST The test is used to validate the sterilizer performance for textile load sterilization. DESCRIPTION It consists of several sheets of paper wrapped in a small packet with a chemical heat-sensitive indicator sheet in the middle. The colour assumed by this indicator sheet at the end of the sterilization cycle gives the result of the test.
- Page 48 Sterilizer tests To set the duration of the Plateau/Sterilization phase and other settings, tap and enter your credentials if required: the chamber door locks. If you have not set a different start time (see "Set the sterilization cycle start" on page 56), the test starts immediately.
- Page 49 Sterilizer tests Outcome of the Outcome of the test Explanation Action test PASSED It represents an acceptable cycle. None. The indicator sheet has changed colour (a uniform pink pattern). FAILED it represents an unexposed test sheet. Repeat the test. If it fails repeatedly, contact technical service.
- Page 50 Sterilizer tests 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 drainage to be finished and the sterilizer to be both cold and dry. Otherwise, a false negative outcome could occur.
- Page 51 Sterilizer tests On the homepage, tap Vacuum test. to see an animated description of the test steps. and enter your credentials if required: the chamber door locks. If you have not set a different start time (see "Set the sterilization cycle start" on page 56), the test starts immediately.
- Page 52 Sterilization cycles CONTENTS DENTAL HANDPIECE EXTERNAL DISINFECTION This section deals with the following subjects: This procedure reduces the risk of infection during cleaning and maintenance of the dental handpieces. Load maintenance and preparation Wear protective gloves during disinfection. Prepare the sterilizer Avoid using abrasive disinfectants (pH-value 2.5 –...
- Page 53 Sterilization cycles DENTAL HANDPIECE EXTERNAL CLEANING CORRECT LOAD PLACEMENT This procedure involves the removal of residues (blood, dentine, WARNING! Do not overload trays and the chamber. Adhere etc.) that adhere to critical areas such as spray outlets, light ports, to the maximum load weight limits (see "Sterilization knurling etc.
- Page 54 Sterilization cycles PARTIAL LOAD Load type Placement If the chamber is just partially loaded, place the load in such a way On trays allowing adequate space in-between Pouched items that the space in-between the trays is maximized. Spread items bags. Ensure that packs do not touch the walls of evenly on two trays.
- Page 55 Sterilization cycles Sterilization cycle management INSERTING THE TRAYS INTO THE STERILIZER CAUTION! Risk of burns. Before touching the chamber trays or contents, ensure the sterilization chamber is not hot. RUN A STERILIZATION CYCLE Note: if the user management and the label printer functions are enabled, Open the chamber door and insert the trays horizontally (one you might be requested to enter your PIN code during the following above the other)See "Load maintenance and preparation"...
- Page 56 Sterilization cycles Tap OPEN: the door unlocks and the homepage appears. 270 °F (132 °C) cycles 250 °F (121 °C) cycles If required, enter your credentials and confirm the load release. Max. 275 °F (135 °C) 255 °F (124 °C) temperature Note: the load release is possible only if the cycle is completed 26.68 psi at 270 °F...
- Page 57 Sterilization cycles office hours). You can set the cycle start date and time and enable or STERILIZATION CYCLE PAGE disable it for each cycle. Following are the information displayed while a cycle is running: On the homepage, tap the cycle and Part Description To change the start time, tap Start cycle at.
- Page 58 Sterilization cycles END OF A STERILIZATION CYCLE STOP A STERILIZATION CYCLE When a cycle is successfully finished, the "Cycle completed" WARNING! You can stop the cycle at any time. Instruments message appears on the screen. To end the cycle: must not be considered sterile if this occurs before the DRY phase.
- Page 59 Sterilization cycles Note: water could be present in the chamber when opening the door. To STORED REPORT FORMAT prevent spilling place a towel below the chamber door. The summarized reports are stored in HTML format and the analytical reports in SCL format. All parameters are recorded every second. MESSAGES OF A STOPPED STERILIZATION CYCLE Following are the messages: WHAT HAPPENS WITH UNSAVED CYCLES...
- Page 60 Sterilization cycles PRINT LABELS FOR A SPECIFIC CYCLE SET THE REMOTE FOLDER FOR SAVING THE REPORTS Note: function available only with the Label printer activation code. To activate the remote storage and set the necessary parameters do the following: On the homepage, tap >...
- Page 61 Sterilization cycles TEST THE DATA STORAGE Note: the test function is available only if the remote data storage is enabled. See "Set the remote folder for saving the reports" on the previous page. On the homepage, tap > > > : ...
- Page 62 Sterilization cycles CYCLE REPORT STRUCTURE Data Description Following the structure of a cycle report: Sterilizer model Sterilizer serial number Software rev. Software revision number Sterilizer Name Surgery – practice – doctor name Cycle Name of the executed cycle Number Cycle counter Sterilizat.
- Page 63 Sterilization cycles Data Description Cycle end at Cycle end date and time Cycle water consumption F0 value Cycle time Cycle time Signature Operator signature "Cycle completed" Cycle outcome Cycle validation (you can choose to accept or reject the Cycle Validation Summary results): Plateau time...
- Page 64 Maintenance CONTENTS CAUTION! Before accessing the chamber and the connected parts, be sure that the sterilizer is cold. This section deals with the following subjects: Notice: follow the instructions in this chapter when carrying out any Warnings for maintenance operations maintenance on the sterilizer.
- Page 65 Maintenance : whichever occurs first. REPLACE THE CONSUMABLE BEFORE THE MAINTENANCE DUE DATE : even if the maximum cycle number is not reached, it is recommended to If you replace the consumables before the request of replacement replace the consumable parts every year, or if they appear worn or damaged, or if the filters are clogged or discolored.
- Page 66 Maintenance 50-cycle or monthly maintenance CLEANING THE DOOR GASKET AND THE CHAMBER FACE SIDE Proceed as follows: Clean the door gasket and the outer edge of the chamber with a non-abrasive cloth moistened with clean water. Notice: do not use abrasive products, cutting tools or sharp objects. Rinse with clean water.
- Page 67 Maintenance CLEANING THE CHAMBER AND THE CHAMBER ACCESSORIES Proceed as follows: Remove the trays. Clean the chamber with a damp sponge and a mild detergent solution paying attention not to bend or damage the temperature probe inside the sterilizer chamber. Rinse with water.
- Page 68 Maintenance CLEANING THE CHAMBER FILTER Proceed as follows: Allow the sterilization chamber to cool down. Empty the sterilizer chamber by removing the trays. Remove the filter at the bottom of the chamber by unscrewing it. Rinse the filters with tap water. Insert the filter in its original position, screwing it into place.
- Page 69 Maintenance 400-cycle maintenance REPLACING THE HEPA FILTER Notice: the HEPA filter needs to be replaced 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 consumable cycle counter. Proceed as follows: Unscrew the HEPA filter by hand (counter-clockwise).
- Page 70 Maintenance 800-cycle or yearly maintenance REPLACING THE DOOR GASKET Notice: the door gasket needs to be replaced every 800 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 consumable cycle counter. Proceed as follows: Open the chamber door.
- Page 71 Maintenance Press left and right. Make sure the door gasket is seated evenly. Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 72 Maintenance Extraordinary maintenance DRAINING THE CLEAN WATER TANK If you left accidentally the tanks full for more than seven days or if you plan not to use the sterilizer for at least seven days, you have to drain the clean water tank. Open the chamber door.
- Page 73 Maintenance Disposal DISPOSAL RESPONSIBILITY Separate the various components according to the materials they are made of Drop the sterilizer with a company that specializes on the recycling of related products Do not abandon the sterilizer in unsecured places Always refer to current/applicable laws and rules in the country of use The same instructions apply to disposal of all used consumable parts.
- Page 74 Diagnostics CONTENTS This section deals with the following subjects: Errors Troubleshooting Emergency door opening Errors CHECKS AND ACTIONS Notice: for any error not listed in this table, contact technical service. Code Description Actions Load cannot be considered sterile. See "End of a sterilization cycle" on page 58. Repeat the cycle.
- Page 75 Diagnostics Code Description Actions Wait before opening the chamber door. Allow the sterilization chamber to cool down. Repeat the cycle. If the problem persists, contact technical service. Switch the sterilizer OFF and ON. Clean the chamber and the chamber furniture from residuals of detergents, disinfectants and other chemicals.
- Page 76 Diagnostics Code Description Actions Check the door gasket. Clean or replace it if necessary. Repeat the cycle. If the problem persists, contact technical service. Clean the chamber face side. Check the load does not exceed the MAXIMUM WEIGHT LIMITS. Clean water error (bad quality, clean tank low level, high consumption of water). Repeat the cycle.
- Page 77 Diagnostics MESSAGES AND ALERTS Notice: for any error not listed in this table, contact technical service. Message/Alert Description Action Fill clean water tank. There is not enough water in the tank to perform a Fill the water tank as requested. cycle.
- Page 78 Diagnostics Message/Alert Description Action Door Gasket replacement is due. These messages advise that one consumable must Replace the consumable and tap to reset the counter (See "Maintenance" on be replaced. page 64). Do you want to replace it now? If you do not replace the consumable, tap Have you replaced the door In this case, you may still use the sterilizer but the message will appear again after gasket?
- Page 79 Diagnostics Troubleshooting ERROR PAGE During the sterilization cycle, the sterilizer is continuously monitored by a control system. If an anomaly is detected, the cycle is aborted MANAGING ERRORS automatically, and the sterilizer starts a reset phase. If during a sterilization cycle an error occurs do the following: The following page appears: Wait until the OPEN button appears.
- Page 80 Diagnostics RESET THE SAFETY THERMOSTAT The sterilizer is fitted with a safety thermostat to prevent it from overheating. If the safety thermostat operates because of too high temperatures, the error 240 or a timeout error is displayed. The thermostat must be reset manually. Proceed as follows: Switch the sterilizer OFF and remove the mains cable.
- Page 81 Diagnostics TROUBLESHOOTING TABLE Note: if your problem is not resolved, call your authorized service provider. Notice: before sending the sterilizer for technical service, remove the mains cable, empty both water tanks and use the original or appropriate packaging. Problem Possible cause Solutions The sterilizer remains switched The mains switch or network circuit breaker is OFF.
- Page 82 Diagnostics Problem Possible cause Solutions Corrosion or spots on Tap water on instruments when placed in the Ensure that instruments are dry before they are placed in the sterilizer. instruments. sterilizer. Use of water of poor quality or water containing Drain both water tanks.
- Page 83 Diagnostics Problem Possible cause Solutions When the sterilizer is connected Water fill system not connected. Connect the water fill system to the sterilizer. See "Water quality" on page 99. to an automated water supply When the water fill system attempted to fill the Since water tank filling is attempted only once in-between cycle execution, this event system: there is no clean water in tank, water was temporarily unavailable.
- Page 84 Diagnostics Emergency door opening WARNING ABOUT OPENING THE DOOR IN EMERGENCY WARNING! High pressure. Risk of explosion, jet of hot steam, sudden opening of the door. Carry out the following procedure only if necessary and only when NO RESIDUAL PRESSURE IS IN THE CHAMBER. Any attempt to open the door while the unit is still hot or under pressure could expose the operator and the surrounding personnel to serious risk.
- Page 85 Diagnostics Plug two batteries into the connectors. Holding the service door pulled, plug the plastic connector into the socket. As soon as the door opens, unplug the plastic connector to prevent system overload and consequent damage. Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 86 Technical data CONTENTS This section deals with the following subjects: Sterilization programs Sterilization cycle phases Technical data Recommendations for validation Diagrams Water quality Accessories, spare parts, consumables Authorized W&H service partners Sterilization programs WARNINGS WARNING! For your safety and for the safety of your patients: Never process objects different from those specified in the cycle program table and never exceed the maximum load weight limits specified in it.
- Page 87 Technical data STANDARD STERILIZATION PROGRAMS The sterilizer offers three preset FDA cleared sterilization programs that comply with the American National Standard ANSI/AAMI ST55. 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.
- Page 88 Technical data STERILIZATION PROGRAM OPTIONS 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, the duration of the drying time can be modified (see "Set the sterilization cycle start"...
- Page 89 Technical data : the total cycle time may vary depending on the type of load (solid or porous), the load weight, the vacuum generation, the duration of the drying phase and other factors. Value and cycle names could be different depending on country requirement. : designed for all items that cannot withstand the high temperatures of the 270 °F (132 °C) cycles, such as textiles, plastics and delicate items.
- Page 90 Technical data Sterilization cycle phases COMMON LEGEND OF THE STERILIZATION CYCLE PHASES Following is the description of the sterilization phases. Code Description Pre-heating of the sterilizer. This phase is not considered a part of the cycle. PV1 - PV3 Vacuum pulse (removal of air from the sterilizer chamber/load). PP1 - PP2 Pressure pulse (steam generation).
- Page 91 Technical data STERILIZATION CYCLE PHASES Wrapped & Porous and Low Temperature sterilization cycles feature the same basic pressure profile as shown in the graph below. The duration and the temperature of the sterilization phase differ between the various cycles. Note: only for Lexa MINI equipped with ejector. Lexa MINI ...
- Page 92 Technical data Note: only for Lexa MINI equipped with vacuum pump. Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 93 Technical data Wrapped and Unwrapped cycles feature the same pressure profile as shown in the graph below. The temperature and the duration of the sterilization phase, and the duration of the de-aeration and evaporation (drying) phases are different from cycle to cycle. Note: only for Lexa MINI equipped with ejector.
- Page 94 Technical data Note: only for Lexa MINI equipped with vacuum pump. Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 95 Technical data Technical data INSTALLATION REQUIREMENTS From +41 °F to +104 °F (from +5 °C to +40 °C) Working temperature Working relative humidity Max. RH 80% up to 88 °F (31 °C), linearly decreasing to 50% at 104 WATER SUPPLY SYSTEM °F (40 °C) Temperature max.
- Page 96 Technical data STEAM GENERATOR Lexa MINI 3 - W: 21.3’’/H: 8.3’’/D: 22.9’’ (W: 54 cm/H: 21 cm/D: 58 Min. space required (overall dimensions + 536 °F (280 °C) Safety thermostats clearance) Lexa MINI 3 - with air conveyor - W: 21.7’’/H: 8.3’’/D: 22.9’’ (W: 55 cm/H: 21 cm/D: 58 cm) Lexa MINI 5 - W: 21.3’’/H: 8.3’’/D: 26.2’’...
- Page 97 Technical data Recommendations for validation TEST VALIDATION POINTS Part Description Hottest points Coldest points Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 98 Technical data Diagrams CONNECTION DIAGRAMS Data communication Water system (*): for water requirements see "Water quality" on the next page. Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 99 Technical data Water quality 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 FEED WATER SPECIFICATIONS (ANSI/AAMI AND AAMI TIR34) accordance with the sterilizer and boiler manufacturers' written IFU.
- Page 100 Technical data Accessories, spare parts, consumables Picture Part Part number Lower tray Lexa MINI 5 F523214X Note: use only accessories, spare parts and consumables recommended by (224 x 44.5 x 175 mm) W&H. Note: before purchasing, check that the accessories fulfill all applicable standards in the country of use.
- Page 101 Technical data Picture Part Part number Picture Part Part number Network data cable RJ45 (3 m) A801500X QR code / Bar code reader for labels 19721132 USB pen drive V000004X Water Distiller 19723101 Report printer 19721141 19723112 Multidem C27 water demineralizer USB-serial converter A801503X Label printer (label printer only)
- Page 102 Technical data Authorized W&H service partners Picture Part Part number Lifting strap F602001X A list and a map with your nearest W&H service partner are available at www.wh.com. Emergency door opening tool F372106X T800003X B&D test pack F540668X Air conveyor External used water tank X051700X CONSUMABLES...
- Page 103 Documentation forms CONTENTS Question Answer This section deals with the following subjects: Completeness of the Instructions for Use W&H installation check-list Were all sections of the Instructions for Use of the sterilizer covered and explained during the in-service? Workplace suitability W&H installation check-list Is the allocated countertop for the sterilizer levelled and flat? Yes Are the recommended ventilation indications of the allocated...
- Page 104 Documentation forms Question Answer Question Answer Have you shown to the Head/personnel of the clinic/practice Have you shown and explained to the Head/personnel of the what the messages and alarms mean? clinic/practice the safety advise section? Have you shown to the Head/personnel of the clinic/practice Have you explained to the Head/personnel of the how to manually abort a cycle? clinic/practice the cybersecurity information?
- Page 105 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: +43 6274 6236-55 Fax: Ignaz-Glaser-Straße 53, Postfach 1 Mail / email: 5111 Bürmoos Austria office.sterilization@wh.com Lexa MINI | Instructions for Use | RIS-303 RIS-305 ENG Rev01 | 04/03/2024 | © W&H Sterilization Srl...
- Page 106 RIS-303 RIS-305 W&H Sterilization Srl Instructions for Use via Bolgara, 2 Brusaporto (BG) Rev01 Italy 04/03/2024 www.wh.com Subject to changes +39 035 66 63 000...
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