W&H lina RIK-1 Instructions For Use Manual
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W&H lina RIK-1 Instructions For Use Manual

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Instructions for Use
RIK-1 - ENG - Rev05
RIK-117 RIK-122

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Summary of Contents for W&H lina RIK-1

  • Page 1 Instructions for Use RIK-1 - ENG - Rev05 RIK-117 RIK-122...

  • Page 3: Table Of Contents

    Table of contents Conformity Printer selection (optional) Symbols and messages Label printer selection (optional) Introduction Label printer usage (optional) About this manual Label content description Use restrictions Sterilizer tests Sterilizer performance tests Safety information Safety warnings Bowie and Dick test Responsibility Helix test Getting started...
  • Page 4 4000 cycle or five-year maintenance Extraordinary maintenance Disposal Diagnostics Errors Troubleshooting Emergency door opening Technical data Sterilization cycles 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 Helix test documentation form Lina ...

  • Page 5: Conformity

    Conformity CONFORMITY TO EUROPEAN REGULATIONS, STANDARDS AND Standards DIRECTIVES Description Directives Sterilizer conforms with the following Regulations, Standards and Directives: Electrical equipment for measurement, control and laboratory use IEC 61326-1 - EMC requirements; general requirements Standards IEC 61770 Electric appliances connected to the water mains - Avoidance of Description backsiphonage and failure of hose-sets Directives...

  • Page 6: Symbols And Messages

    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 OFF (supply) IEC 60417- 5008 Transportation IN-position of bistable push Unique Device Identification control IEC 60417-5268 Medical Device Only for MDR devices Health industry bar code in OUT- position of bistable accordance with HIBC Serial Number push control IEC 60417- Standard 5269 Small Steam Sterilizer...

  • Page 8: Introduction

    Introduction CONTENTS OBLIGATIONS WITH REGARD TO THIS MANUAL This section deals with the following subjects: This manual is an integral part of the product and accompanies it for its entire working life. It must be consulted in all situations related to About this manual the life cycle of the product, from its delivery through to Use restrictions...

  • Page 9: Use Restrictions

    Introduction The devices are intended for professional use by trained people COPYRIGHT NOTICE only. Copyright ©, W&H Sterilization Srl All rights reserved in all countries. PROVIDED FEATURES See "Sterilization cycles" on page  96 for the full list of key program All drawings, images and texts contained in this manual are the features, including sterilization time, temperature and recommended property of the manufacturer.

  • Page 10: Safety Information

    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 11: Responsibility

    Safety information the access to the device operating system is not possible (user TAMPERING access to the operating system is disabled); a firewall is active on the device; all the device network Do not remove the name plate or labels from connections (to and from the external world) are managed by the sterilizer.
  • Page 12 Safety information Instructions for Use. The safety devices of the sterilizer are impaired when the product itself is not installed, used and serviced in accordance with these Instructions for Use. The Instructions for Use updated to the latest version is always available at www.wh.com.

  • Page 13: Getting Started

    Getting started CONTENTS Unpacking This section deals with the following subjects: Unpacking UNPACK THE STERILIZER Handling CAUTION! Heavy product. The sterilizer must be removed Product description from the box and transported by two authorized technicians. Installing the sterilizer Weight: Operating the sterilizer Lina 17: 41.5 kg (91.5 lbs) User interface menu Lina 22: 43.5 kg (95.9 lbs)
  • Page 14 Getting started WARNINGS CONTENTS OF THE PACKAGING Notice: check the external conditions of the box and the sterilizer. 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.

  • Page 15: Handling

    Getting started Tray holder Mains cable USB pen drive loaded with This manual, declaration of Instructions for Use conformity, warranty card, work test report, maintenance sheet ITEMS NOT PROVIDED WITH THE STERILIZER The following items are not provided: Water container to capture waste water during manual tank draining (volume larger than 5 l (1.3 gal)) LAN cable for connecting the sterilizer to a network (optional) See "Accessories, spare parts, consumables"...
  • Page 16 Getting started Use original packaging when shipping or transporting the sterilizer. Replacement packaging materials are available from Service W&H Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...

  • Page 17: Product Description

    Getting started Product description FRONT VIEW AND UPPER INTERNAL STRUCTURE Part Description Chamber door Tank Water level sensor Water tank cover Tank filling cover-cap Water tank cover Internal tank cover Tank internal filters with metal cartridges Touch screen Service door Sterilization chamber Dust filter Reset button of the thermostat switch...
  • Page 18 Getting started COMPONENTS BEHIND THE SERVICE DOOR Part Description Bacteriological filter Mains switch Identification label Used water drain port (grey) Clean water drain port (blue) Drain tube release button USB port Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...
  • Page 19 Getting started REAR VIEW Part Description USB port (optional) Air gap cover Test connection Pressure safety valve cover Used water drain (optional) Water supply inlet (optional) Condenser grid Mains cable guide Mains cable plug socket Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...
  • Page 20 Getting started CHAMBER ACCESSORIES Part Description Tray Chamber rack: In the normal position, it can host 5 trays horizontally or 3 cassettes/containers vertically. In a 90° degrees rotated position, it can host 3 trays or 3 cassettes/containers horizontally. Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...

  • Page 21: Installing The Sterilizer

    Getting started Installing the sterilizer Clearance requirements to ensure proper air circulation: LOCATION REQUIREMENTS Notice: Do not place the sterilizer so that it is difficult to operate the controls behind the service door. Do not place the sterilizer so that it is difficult to disconnect the power supply plug.
  • Page 22 Getting started The installation of the sterilizer shall be performed by two authorized INSTALLING THE STERILIZER technicians using PPE (Personal Protective Equipment) according to WARNING! In case of sterilizer malfunctions immediately applicable standards. unplug the sterilizer and call for service. Do not attempt to The electrical power supply of the sterilizer must fulfill all applicable repair the sterilizer by yourself.

  • Page 23: Operating The Sterilizer

    Getting started Operating the sterilizer HOMEPAGE DESCRIPTION Part Description POWER THE STERILIZER ON/OFF Title/purpose of the Press the power switch behind the service door: once switched screen, or the cycle ON, the visual indicator on the power switch turns green. number and the current date and time After a quick autotest the sterilizer automatically turns in...

  • Page 24: User Interface Menu

    Getting started User interface menu SETTINGS MENU FUNCTIONS Icon Label Function MAIN MENU FUNCTIONS Device Opens the pages to set the device. Icon Label Function Menu Opens the menu. Language Sets device language. Cycle History Shows all the sterilization cycles. Date &...
  • Page 25 Getting started Icon Label Function Icon Label Function Cycle Exclusion IoDent Only if this service is supported in the country of use, Sets the cycles menu. and if the sterilizer is connected to it. Shows the status of the connection with the W&H monitoring server.
  • Page 26 Getting started Icon Label Function Icon Function Label Guided Allows to start the configuration of: Change your Changes the PIN code. language; Configuration PIN code network connection; time zone settings; Options Optional, activated with an activation code. date & time settings; Administrator only.
  • Page 27 Getting started MAINTENANCE MENU FUNCTIONS Icon Label Function Icon Label Function Label Printer Optional, activated with an activation code. Permits to select the label printer and sets the printout layout. Bact. Filter Shows the status of the consumables; Resets the cycle counter; Local Printer Selects a printer connected to the sterilizer.
  • Page 28 Getting started COMMON COMMANDS AND ICONS Icon Function Icon Function Icon Function Refreshes the page. Indicates that an error occurs. Enters/exits the standby mode. Indicates the value that may be Indicates that the option checked is changed and appears by clicking on working properly.
  • Page 29 Getting started Icon Function Icon Function Indicates that the option is OFF and Shows a sterilization summary. allows to set it ON by touching it. Indicates that the option is active/not active. Indicates that the option is enabled/disabled. Indicates that the user is using the administrator credentials.

  • Page 30: Sterilizer Setup

    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 On the homepage, tap > > > At the first start-up of the sterilizer, the Guided Configuration procedure automatically appears;...

  • Page 31: User Authentication (Optional)

    Getting started Note: in the TPC/IP screen, the icon is visible only if you SET THE DISPLAY BRIGHTNESS make any change. The Wi-Fi icon at the bottom isn't visible if To change the display brightness: you connect through Ethernet cable. On the homepage, tap >...

  • Page 32: Usb Pen Drive

    Getting started USB pen drive 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. A USB pen drive is available to be installed in order to automatically record all the sterilization cycle reports.
  • Page 33 Getting started used for a certain period of time, it automatically switches to Standby mode. ENTER THE STANDBY MODE MANUALLY Homepage EXIT THE STANDBY MODE or open or close the chamber door. CHANGING STANDBY MODE DELAY TIME On the homepage, tap >...

  • Page 34: Administrator

    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. User management (optional) Tap the text box:  a keyboard appears. Enter the new user name and tap to confirm.

  • Page 35: Traceability Options (Optional)

    Administrator To acquire the activation code please refer to the Activation code instructions. Tap the user name you want to delete. to confirm. WHO CAN SET THE TRACEABILITY OPTIONS Only a user with administrator rights can set the traceability options. RESET A USER PIN On the homepage, tap >...

  • Page 36: Managing Printers

    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 37: Label Printer Usage (Optional)

    Managing printers to confirm the settings and go back to the previous page. SET THE AUTOMATIC LABEL PRINTING On the homepage, tap > > Label printer usage (optional) Activate Automatic printing. to set the maximum storage time and the number CAUTION! For your safety and the safety of your patients of labels to be printed automatically.

  • Page 38: Label Content Description

    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 39: Sterilizer Tests

    Sterilizer tests CONTENTS This section deals with the following subjects: Sterilizer performance tests Bowie and Dick test Helix 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 40 Sterilizer tests 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 41 Sterilizer tests Empty the sterilizer chamber to ensure no load is present. Remove all trays from the sterilization chamber, except the lowest one. Place the Bowie and Dick test pack in the center of a tray in the lowest rack position and close the chamber door.
  • Page 42 Sterilizer tests INTERPRET THE TEST RESULT Test Indicator What happened What to do next passed The entire surface of the indicator sheet has changed colour. Certain areas of the indicator sheet have not changed colour since there was an Repeat the test. If it fails air pocket during the cycle due to sterilizer malfunction.

  • Page 43: Helix Test

    Sterilizer tests Helix 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 hollow items. DESCRIPTION It consists of a 1.5 m long tube open on one side and closed with a capsule containing a chemical indicator strip on the other side. The colour assumed by this indicator strip at the end of the sterilization cycle gives the result of the test.
  • Page 44 Sterilizer tests Place the tube with the capsule in the center of a tray in the lowest rack position and close the chamber door. On the homepage, tap Helix-B&D test. To set the duration of the Plateau/Sterilization phase and other settings, tap and enter your credentials if required: the chamber door locks.

  • Page 45: Vacuum Test

    Sterilizer tests Vacuum test CAUTION! Follow local/national guidelines on the frequency of testing. Notice: If a drainage period of the S Naked 134 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 46 Sterilizer tests WHAT TO DO WHEN THE TEST FAILED Check, clean or replace the door gasket. Clean the chamber face side and the chamber filter. Repeat the Vacuum test. See "Carry out the test" on the previous page. If the test fails repeatedly, call technical service. Lina ...

  • Page 47: Sterilization Cycles

    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 48 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 49: Prepare The Sterilizer

    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 multiple trays.

  • Page 50: Sterilization Cycle Description

    Sterilization cycles Open the chamber door and align the chamber rack at the HOOKING AND REMOVING THE STEAM DIFFUSER PLATE center/bottom of the chamber. WARNING! Ensure that the steam diffuser plate is firmly Push the chamber rack gently into position until it clicks into hooked in its position before starting a sterilization cycle.

  • Page 51: Sterilization Cycle Management

    Sterilization cycles Sterilization cycle management ECO-B MODE ECO-B is a cycle option designed to reduce the cycle duration and the overall energy consumption, providing a fast type B cycle for a S NAKED 134 CYCLE ACTIVATION limited load weight (max. 0.5 kg of unwrapped, bagged, single/double wrapped items).
  • Page 52 Sterilization cycles if you need to set the drying time. Tap the time or the date: a settings page opens. and enter your credentials if required: the door locks. If Tap the number you want to change and tap you have not set a different start time, the sterilization starts increase it or decrease it.
  • Page 53 Sterilization cycles VIEW THE CYCLE PARAMETERS STERILIZATION CYCLE PAGE You can check the real time cycle parameters or the cycle Following are the information displayed while a cycle is running: parameters at the end of the cycle. Following is an example: Part Description While the sterilization cycle is running or when cycle ends tap...
  • Page 54 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 55: Unloading

    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 WHAT HAPPENS WITH UNSAVED CYCLES Following are the messages:...
  • Page 56 Sterilization cycles to print the report, or tap to save the report on the SET THE REMOTE FOLDER FOR SAVING THE REPORTS USB pen drive. (OPTIONAL) Function availability PRINT LABELS FOR A SPECIFIC CYCLE The first time you access the Remote Data Storage ( ) menu, you Note: function available only with the Label printer activation code.
  • Page 57 Sterilization cycles to save. SAVE ALL THE CYCLE REPORTS IN A REMOTE FOLDER to go back to the previous page. (OPTIONAL) Note: the save all function is available only if the remote data storage is To check if the parameters entered are valid, see "Test the data enabled.
  • Page 58 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 59 Sterilization cycles Data Description Cycle time Cycle time Date (below) Cycle end date and time "Cycle completed" Cycle outcome Trk. Tracking code for traceability management Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...

  • Page 60: Maintenance

    Maintenance CONTENTS Warnings for maintenance operations This section deals with the following subjects: WARNINGS Warnings for maintenance operations Ordinary maintenance WARNING! Turn the sterilizer OFF and remove the power cord before beginning any maintenance. Follow all health, Monthly or 50-cycle maintenance safety, cross-infection and cross-contamination 400-cycle maintenance protocols.

  • Page 61: Ordinary Maintenance

    Maintenance Ordinary maintenance damaged, or if the filters are clogged or discolored. EXPIRED MAINTENANCE MAINTENANCE BY THE USER The sterilizer monitors the wear of consumables by counting the number of cycles executed since the last replacement. Frequency Cycles Operation When the number of cycles is close to the maximum, a pre-alert Cleaning the door gasket and the chamber face Monthly side.
  • Page 62 Maintenance When you have replaced the consumable tap to confirm: the executed cycle counter is reset. Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...

  • Page 63: Monthly Or 50-Cycle Maintenance

    Maintenance Monthly or 50-cycle maintenance CLEANING THE DOOR GASKET AND THE CHAMBER FACE SIDE Proceed as follows: Clean the gasket seat and the chamber face side with a damp, lint-free cloth moistened with clean water. Notice: Do not use abrasive products, cutting tools or sharp objects. Rinse with clean water.
  • Page 64 Maintenance CLEANING THE CHAMBER AND THE CHAMBER ACCESSORIES Proceed as follows: Remove the trays, the chamber rack and the steam diffuser plate. 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.
  • Page 65 Maintenance CLEANING THE CHAMBER FILTER Proceed as follows: Allow the sterilization chamber to cool down. Empty the sterilizer chamber by removing the trays and the rack. Turn the filter cap at the back of the chamber (bottom/center) counter-clockwise. Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...
  • Page 66 Maintenance Remove the filter cap and the cartridge filter. Rinse the cartridge filter with tap water. Insert the cartridge filter in the filter cap. Insert the filter cap with the cartridge filter in its original position. Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...
  • Page 67 Maintenance Lock the filter cap by turning it clockwise. CLEANING THE EXTERNAL SURFACES OF THE STERILIZER Proceed as follows: Clean all external sterilizer covers with a slightly damp cloth moistened with water. For better cleaning results, clean with W&H MC-1000 cleaning solution. Notice: never use any other disinfectant, detergent or abrasive product, as they might result aggressive for the external covers and damage them.

  • Page 68: 400-Cycle Maintenance

    Maintenance 400-cycle maintenance REPLACING THE BACTERIOLOGICAL FILTER 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  61. Proceed as follows: Open the service door.
  • Page 69 Maintenance REPLACING THE DUST FILTER 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  61. Proceed as follows: Open the chamber door. Pull out the dust filter handle from underneath the sterilizer.
  • Page 70 Maintenance Insert the new filter into the handle. Slide the handle back into its original position. Close the chamber door. Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...

  • Page 71: 800-Cycle Or Biannual Maintenance

    Maintenance 800-cycle or biannual maintenance SEQUENCE OF PROCEDURES TO CLEAN THE WATER TANKS To clean the water tanks, proceed as follows: "Prepare the sterilizer for cleaning the water tanks" below. "Access to the water tanks" on the next page. "Clean the water tanks" on page  74 PREPARE THE STERILIZER FOR CLEANING THE WATER TANKS Proceed as follows: Switch OFF the sterilizer and disconnect the mains cable.
  • Page 72 Maintenance ACCESS TO THE WATER TANKS Proceed as follows: Lift the water tank cover. Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...
  • Page 73 Maintenance Remove the internal tank cover. Clean and dry the internal tank cover and its rubber membrane to eliminate any condensate. Notice: never use disinfectants, strong detergents or abrasive products. Use a slightly damp cloth moistened with water. Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...
  • Page 74 Maintenance CLEAN THE WATER TANKS Notice: Do not touch the water level sensors. If misplaced or misaligned from their original position, the operation of the sterilizer could be impaired. Proceed as follows: Clean the internal tank surfaces with a soft sponge moistened with water. For better cleaning results, clean with W&H MC-1000 cleaning solution.
  • Page 75 Maintenance Remove the internal filters. Clean the metal cartridges of the internal filters with tap water. Reposition the internal filters. Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...
  • Page 76 Maintenance Reposition the internal tank cover and then the water tank cover. Detach the drain tube. Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...

  • Page 77: 800-Cycle Maintenance

    Maintenance 800-cycle maintenance REPLACING THE DOOR GASKET 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  61. Proceed as follows: Fully open the chamber door.
  • Page 78 Maintenance Insert the new seal and press first up and down. Press left and right and then the entire seal circumference to ensure its perfect placement. Notice: a steam discharge can damage the sterilizer plastic parts. Ensure the seal does not stick out. Wipe any residual water and run a Vacuum and Helix test to check for perfect tightness of the seal.

  • Page 79: 4000 Cycle Or Five-Year Maintenance

    Maintenance 4000 cycle or five-year maintenance Element Replace Clean Check Internal parts, with particular care for the condenser fins and the main board GENERAL CHECK AND SERVICE REQUIRED Notice: regular service is imperative to ensure continuous and Steam diffuser plate effective operation of the sterilizer.

  • Page 80: Extraordinary Maintenance

    Maintenance Extraordinary maintenance DRAINING THE USED AND 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 tanks.

  • Page 81: Disposal

    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 82: Diagnostics

    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, call technical service. Code Description Actions Load cannot be considered sterile. See "End of a sterilization cycle" on page  54 Repeat the cycle.
  • Page 83 Diagnostics Code Description Actions Wait before opening the chamber door. Allow the sterilization chamber to cool down. See error "13x to 16x" Repeat the cycle. below. If the problem persists, call service. 13x to 16x Check water level in the clean water tank. Reset the safety thermostat.. Repeat the cycle.
  • Page 84 Diagnostics Code Description Actions Check the door gasket. Clean or replace it if necessary. Repeat the cycle. If the problem persists, call service. Clean the chamber face side. Clean the chamber filter. Check if chamber filter is properly locked in the cap. Check the load does not exceed the MAXIMUM WEIGHT LIMITS.
  • Page 85 Diagnostics MESSAGES AND ALERTS Notice: for any error not listed in this table, call 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 86 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  60). Have you replaced the door gasket? If you don't replace the consumable, press In this case, you may still use the sterilizer but the message will appear again after Bact.

  • Page 87: Troubleshooting

    Diagnostics The following page appears: Troubleshooting Part Description MANAGING ERRORS Current sterilization If during a sterilization cycle an error occurs do the following: cycle Wait until the end of the reset phase. Error number, See "Errors" on page  82 . CAUTION! Do not switch off the sterilizer during the reset Warning messages.
  • Page 88 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 89 Diagnostics Insert the dust filter back into its original position. Close the chamber door. Connect the mains cable and place the sterilizer back into its original position. Switch the sterilizer ON. Wait for the sterilizer to finish the error reset phase and follow the instructions on the display.
  • Page 90 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 91 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 92 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  109 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 93: Emergency Door Opening

    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 94 Diagnostics OPEN THE DOOR IN EMERGENCY Unplug the sterilizer and wait at least three hours. Take the emergency door opening tool included in the sterilizer box. Firmly open the service door. Unscrew the bacteriological filter by hand (counter-clockwise). Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...
  • Page 95 Diagnostics Plug two batteries into the connectors. Holding the service door pulled, plug the plastic connector into the socket behind the bacteriological filter. As soon as the door opens, unplug the plastic connector to prevent system overload and consequent damage. Lina ...

  • Page 96: Technical Data

    Technical data CONTENTS This section deals with the following subjects: Sterilization cycles Sterilization cycle phases Technical data Recommendations for validation Diagrams Water quality Accessories, spare parts, consumables Authorized W&H service partners Sterilization cycles WARNINGS For your safety and for the safety of your patients: WARNING! Never process objects different from those specified in the cycle program table and never exceed the maximum load weight limits specified in it as this could impair the sterilization process.
  • Page 97 Technical data STANDARD STERILIZATION CYCLES AVAILABLE There are four sterilization cycles available, all of them complying with the European Standard EN13060: three B-type cycles one S-type cycle (optional, activated with S Naked cycle activation code. See "S Naked 134 cycle activation" on page  51) Cycle Cycle name Purpose...
  • Page 98 Technical data COMMON STERILIZATION CYCLE DATA Sterilization cycles B Universal 134 B Prion / Extended 134 B Universal 121 S Naked 134 (optional) 134 °C (273 °F) 134 °C (273 °F) 121 °C (250 °F) 134 °C (273 °F ) Sterilization temperature 3.03 bar 3.03 bar...
  • Page 99 Technical data TOTAL CYCLE DURATION (200-240 V AC VERSION) The total cycle time includes the drying time and may vary according to different elements, such as the following: type of load (solid or porous) load weight other factors Load Empty Full Typical (2.0 kg) Eco (0.5 kg)
  • Page 100 Technical data TOTAL CYCLE DURATION (100-125 V AC VERSION) The total cycle time includes the drying time and may vary according to different elements, such as the following: type of load (solid or porous) load weight vacuum generation duration of the drying phase other factors Load Empty...
  • Page 101 Technical data MAXIMUM LOAD FOR INSTRUMENTS Note: the load given includes the trays, the containers and everything is put into the chamber, with the sole exclusion of the tray rack. Instruments Bagged Unwrapped Porous Lina 17 Lina 22 Lina 17 Lina 22 Lina 17 Lina 22...

  • Page 102: Sterilization Cycle Phases

    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. Heating phase (heat the chamber and the load) PV1 - PV2 Vacuum pulse (removal of air from the sterilizer chamber/load) PP1 - PP2...
  • Page 103 Technical data TYPE B STERILIZATION CYCLE PHASES All type B sterilization cycles feature the same basic pressure profile as shown in the graph below. The duration and the temperature sterilization phase differ between the various cycles. Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...
  • Page 104 Technical data TYPE S STERILIZATION CYCLE PHASES The S Naked 134 cycle is specifically designed to sterilize unwrapped instruments, for immediate use on patients, not requiring a complete drying. Thus, the drying phase of this cycle is short and not assisted by vacuum, making this cycle the fastest available. Lina ...

  • Page 105: Technical Data

    Technical data Technical data INSTALLATION REQUIREMENTS From +5 °C to +40 °C (from +41 °F to +104 °F) Working temperature Working relative humidity Max. RH 80% up to 31 °C (88 °F), linearly decreasing to 50% at 40 WATER SUPPLY SYSTEM °C (104 °F) Temperature max.
  • Page 106 Technical data STERILIZER CHAMBER 2.6 bar (37.7 psi) Pressure safety valve Safety thermostats 180 °C (356 °F) 330 °C (626 °F) - built-in steam generator Total volume Lina 17 - 17 l/Ø: 250 mm/D: 362 mm (4.5 gal , Ø: 9.8’’/D: 14’’) Lina 22 - 22 l/Ø: 250 mm/D: 440 mm (5.8 gal , Ø: 9.8’’/D: 17’’) Usable space *...

  • Page 107: Recommendations For Validation

    Technical data Recommendations for validation TEST VALIDATION POINTS Lina sterilizers can be validated in accordance to EN ISO 17665-1. For further details please refer to the Qualification/Validation guide for sterilization cycles of the manufacturer. Part Description Hottest points Coldest points Lina ...

  • Page 108: Diagrams

    Technical data Diagrams CONNECTION DIAGRAMS Data communication Water system (*): the water filtration system must be fitted with a backflow preventing device complying to IEC 61770 and to national and local regulations. For water requirements see "Technical data" on page  105. (**): rear serial connection.

  • Page 109: Water Quality

    Technical data Water quality Contaminants/minerals/qualities Value/Specification Hardness < 0.02 mmol/l FEED WATER SPECIFICATIONS (EN 13060) No chemicals or additives must be added Chemical additives Notice: do not use rust inhibitor or any other agents in the clean to the water used for the steam water tank.

  • Page 110: Accessories, Spare Parts, Consumables

    Technical data Accessories, spare parts, consumables Picture Part Part number Standard chamber rack for 5 F523032X aluminium trays for Lina 22 Note: use only accessories, spare parts and consumables recommended by W&H. Usable space - Tray size (mm): 190 x 21 x 387 Note: before purchasing, check that the accessories fulfill all applicable 190 x 28 x 387 standards in the country of use.
  • Page 111 Technical data Picture Part Part number Picture Part Part number Optional chamber rack for 4 F523012X Optional chamber rack for 3 F523020X cassettes / containers for Lina cassettes / containers for Lina Usable space - Cassette size Usable space - Tray size (mm): 205 x 36 x 300 (mm): 210 x 36 x 300...
  • Page 112 Technical data Picture Part Part number Picture Part Part number Optional chamber rack for 6 F523034X Optional chamber rack for 2 F523035X aluminium trays for Lina 22 aluminium trays and 3 wider aluminium trays for Lina 22 Usable space - Tray size (mm): 190 x 15 x 387 Usable space - Tray size (mm): 190 x 22 x 387...
  • Page 113 Technical data Picture Part Part number Picture Part Part number Optional chamber rack for 6 F523041X Drain tube kit with fittings A812110X aluminium trays for Lina 22 Usable space - Tray size (mm): 190 x 15 x 387 S230900X 190 x 22 x 387 Drain tube 190 x 22 x 387 190 x 22 x 387...
  • Page 114 Technical data Picture Part Part number Picture Part Part number QR code / Bar code reader for labels 19721132 AWF kit X051500X Water Distiller 19723101 Data port panel (USB kit) X051405X Multidem C27 water demineralizer 19723112 (only with AWF kit) Water quality sensor kit X051513X Osmo water demineralizer (220 V)

  • Page 115: Authorized W&H Service Partners

    Technical data CONSUMABLES Activation code Description Part number Picture Part Part number When replace it Traceability Activates the User Management and Options 19730011 menus Bacteriological filter W322400X Every 400 cycles (bagged) All in One Activates: 19730013 S Naked cycle F460504X Every 800 cycles Door gasket Traceability...

  • Page 116: Documentation Forms

    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? Helix test documentation form Workplace suitability Is the allocated countertop for the sterilizer levelled and flat? Yes W&H installation check-list...
  • Page 117 Documentation forms Question Answer Question Answer Have you shown the Head of the clinic/practice how to Have you executed a B Universal 134 cycle program with the manually abort a cycle? tray rack and trays inserted? Have you shown the Head of the clinic/practice the Are all connections to the sterilizer well positioned and maintenance program and procedures? plugged (accessories, etc…)?
  • Page 118 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 5111 Bürmoos Austria Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...

  • Page 119: Helix Test Documentation Form

    Documentation forms Helix test documentation form INSTRUCTIONS Use this page to create a logbook tracing the effectiveness of the sterilization cycle during the whole lifespan of your sterilizer. FORM Date Cycle n. Operator Released Signature Chemical indicator Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...
  • Page 120 Documentation forms Date Cycle n. Operator Released Signature Chemical indicator Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...
  • Page 121 Documentation forms Date Cycle n. Operator Released Signature Chemical indicator Lina  | Instructions for Use |  RIK-1 ENG Rev05 |  16/09/2022 |  © W&H Sterilization Srl...
  • Page 122 RIK-1 W&H Sterilization Srl Instructions for Use via Bolgara, 2 Brusaporto (BG) Rev05 Italy 16/09/2022 www.wh.com Subject to changes +39 035 66 63 000...

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