W&H Med lina Instructions For Use Manual Download Page 98

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Technical data

Recommendations for validation

TEST VALIDATION POINTS

LINA sterilizers can be validated in accordance to EN17665-1.

For further details please refer to the Qualification/Validation guide
for sterilization cycles of the manufacturer.

Part

Description

Hottest points

Coldest points

Summary of Contents for lina

Page 1: ...RIK 117 RIK 122 Instructions for Use RIK 1 Med ENG Rev03 ...

Page 2: ......

Page 3: ...r management optional 31 Traceability options optional 32 Managing printers 33 Printer selection optional 33 Label printer selection optional 33 Label printer usage optional 34 Label content description 35 Sterilizer tests 36 Sterilizer performance tests 36 Bowie and Dick test 36 Helix test 39 Vacuum test 41 Sterilization cycles 43 Load maintenance and preparation 43 Prepare the sterilizer 45 Ster...

Page 4: ...s 75 Errors 75 Troubleshooting 80 Emergency door opening 86 Technical data 89 Sterilization cycles 89 Sterilization cycle phases 93 Technical data 96 Recommendations for validation 98 Diagrams 99 Water quality 100 Accessories spare parts consumables 101 Authorized W H service partners 107 Documentation forms 108 W H installation check list 108 Helix test documentation form 110 ...

Page 5: ...described in the module D1 AnnexIII 2012 19 EU Waste Electrical and ElectronicEquipment WEEE EN 13060 Small steam sterilizers IEC 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use general requirements IEC 61010 2 040 Safety requirements for electrical equipment for measurement control and laboratory use particular requirements for sterilizers and washe...

Page 6: ...uld lead 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 Risk of burns Consult the Instructions for Use for important cautionary information Don t use drinking water to fill the clean water tank use only distilled or demineralized water Consult the Ins...

Page 7: ...al is an integral part of the product and accompanies it for its entire working life It must be consulted in all situations related to the life cycle of the product from its delivery through to decommissioning For this reason it should always be accessible to operators both online and offline Contact customer service in the event the manual is unavailable If the device is transferred always attach...

Page 8: ...nd equipment which are likely to come into contact with blood or bodily fluids e g implements used by beauty therapists tattooists body piercers and hairdressers The devices are intended for professional use only by trained people PROVIDED FEATURES See Sterilization cycles on page 89 for the full list of key program features including sterilization time temperature and recommended load type USER Q...

Page 9: ...quids over the sterilizer risk of electrical short circuits n Switch off the sterilizer and unplug the mains cable before inspecting carrying out maintenance or servicing the sterilizer n Ensure that the power receptacle the sterilizer is connected to is properly grounded n All electric devices connected to the sterilizer shall be of Insulation Class II double insulated or higher n Use only the po...

Page 10: ... a list of security information is mentioned in the MDS2 document which is available on request Responsibility USER RESPONSIBILITY n The user is responsible for the proper installation the correct use and maintenance of the sterilizer in accordance with these Instructions for Use n The safety devices of the sterilizer are impaired when the product itself is not installed used and serviced in accor...

Page 11: ...duct description 14 Installing the sterilizer 18 Operating the sterilizer 20 User interface menu 21 Sterilizer setup 27 User authentication optional 28 USB pen drive 29 Standby mode 29 Unpacking UNPACK THE STERILIZER CAUTION Heavy product The sterilizer must be removed from the box and transported by two authorized technicians Weight n LINA 17 41 5 kg 91 5 lbs n LINA 22 43 5 kg 95 9 lbs ...

Page 12: ...ge immediately contact the dealer or shipping agent that has carried out the transport Keep the packaging for shipping or transporting the sterilizer in the future Note The packaging of the product is environmentally friendly and can be disposed of by industrial recycling companies CONTENTS OF THE PACKAGING Sterilizer Trays three Emergency door opening tool Reversible rack Tray holder Mains cable ...

Page 13: ...ed n Water container to capture waste water during manual tank draining volume larger than 5 l 1 3 gal n LAN cable for connecting the sterilizer to a network optional See Accessories spare parts consumables on page 101 for a full list of optional accessories Handling HOW TO RELOCATE THE STERILIZER Before transport n Completely drain both water tanks see Draining the used and clean water tank on pa...

Page 14: ...UCTURE Part Description A Chamber door B Tank C Water level sensor D Water tak cover E Tank filling cover cap F Water tank cover G Internal tank cover H Tank internal filters with metal cartridges I Touch screen L Service door M Sterilization chamber N Dust filter O Reset button of the thermostat switch P Emergency door opening tool Q Door seal R Door pin ...

Page 15: ...Rev03 11 05 2020 2020 W H Sterilization Srl 15 COMPONENTS BEHIND THE SERVICE DOOR Part Description A Bacteriological filter B Mains switch C Identification label D Used water drain port grey E Clean water drain port blue F Drain tube release button G USBport ...

Page 16: ...1 05 2020 2020 W H Sterilization Srl REAR VIEW Part Description A USBport optional B Air gap cover C Test connection D Pressure safety valve cover E Used water drain optional F Water supply inlet optional G Condenser grid H Mains cable guide I Mains cable plug socket ...

Page 17: ...020 W H Sterilization Srl 17 CHAMBER ACCESSORIES Part Description A Tray B Chamber rack n In the normal position it can host 5 trays horizontally or 3 cassettes containers vertically n In a 90 degrees rotated position it can host 3 trays or 3 cassettes containers horizontally ...

Page 18: ...uous pay attention to the surrounding materials steam can damage them The sterilizer must operate in absence of explosive atmospheres 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 proper air circulation ELECTRICAL CONNECTIONS All the cables and tube...

Page 19: ...elevant system WI FI CONNECTION OPTIONAL For the Wi Fi connection proceed as follows 1 Insert the Wi Fi key in the USB port 2 Read the Instructions for Use provided with the Wi Fi key Note for details see also the Wi Fi key APP Quick start INSTALLING THE STERILIZER WARNING In case of sterilizer malfunctions immediately unplug the sterilizer and call for service Do not attempt to repair the sterili...

Page 20: ...a quick autotest the sterilizer automatically turns in standby mode See Standby mode on page 29 3 Tap The homepage appears with the enabled sterilization cycles HOMEPAGE DESCRIPTION Part Description A Title purpose of the screen or the cycle number and the current date and time B Available cycles Note The S Naked 134 cycle is optional activated with Fast Cycle activation code see Sterilization cyc...

Page 21: ...rmat the USBpen drive and activate special functions Maintenance Carries out the maintenance procedure System Info n In general shows the system information n During a cycle shows the cycle parameters in real time SETTINGS MENU FUNCTIONS Icon Label Function Device Opens the pages to set the device Language Sets the language Date Time Sets time and date values and format Sterilizer Name Sets the st...

Page 22: ... storage Only with a network connection set Opens the page to manage the remote storage Settings Only with a network connection set Sets the parameters of the network location Icon Label Function Save all Only with a network connection set Copies all the files in the specified location in the network Test Only with a network connection set Checks if the files can be copied to the specified locatio...

Page 23: ... printing of the labels ACCESSORIES MENU FUNCTIONS Icon Label Function USBPen Drive Opens the formatting page of the USBpen drive Format Formats the USBpen drive Icon Label Function Label Printer Optional activated with an activation code Selects the label printer and sets the printout layout Local Printer Selects a printer connected to the sterilizer Calibration Adjusts the label printer to the e...

Page 24: ...ization Srl Getting started Icon Label Function Door Gasket Shows the status of the door gasket for replacement and resets its counter to zero 4000 cycle service Shows the number of cycles performed and left before the necessary maintenance Software Update Updates the software ...

Page 25: ...rming making any changes nor saving any parameters n Answers NOto a question Indicates that the AUTODRYmode is operating Optional activated with an activation code Indicates that the ECODRYplus mode is operating Increases decreases the value Icon Function Indicates that an error occurs Indicates that the option checked is working properly n Plays a video n Starts a procedure Pauses a video Indicat...

Page 26: ...ates that the option is active not active Indicates that the option is enabled disabled Indicates that the user is using the administrator credentials Gives information about the function displayed Confirms the active option and saves a setting or a parameter Copy the system info to the USBpen drive Shows an animation about the replacement procedure Icon Function Shows a sterilization summary ...

Page 27: ...irm and go back to the previous page SET THE STERILIZER NAME To change the sterilizer name that appears in the cycle reports 1 On the homepage tap 2 Tap the text box a keyboard appears 3 Enter the new sterilizer name 4 Tap to confirm 5 Tap to go back to the previous page SET THE DISPLAY BRIGHTNESS To change the display brightness 1 On the homepage tap 2 Tap or to change the value 3 Tap to confirm ...

Page 28: ...n tap to confirm all entry fields are disabled 5 If your network does not support dynamic IP addresses ask your IT manager enable the options Static both in IP Configuration and in the DNS Configuration fields Tap on each entry field and enter the IP addresses ask your IT manager for details Then tap to confirm User authentication optional FUNCTION AVAILABILITY To access the user management functi...

Page 29: ...reports The USB pen drive can be inserted equally into the front or rear port optional Notice Periodically remove the USB pen drive to save the cycle data on a computer or on another safe support FORMAT THE USB PEN DRIVE 1 On the homepage tap 2 Insert the USB pen drive in one of the two USB ports 3 Tap 4 Tap to confirm all data will be erased Notice Formatting erases all data from the pen drive Be...

Page 30: ...ons for Use RIK 1 Med ENG Rev03 11 05 2020 2020 W H Sterilization Srl Getting started CHANGING STANDBY MODE DELAY TIME 1 On the homepage tap 2 Tap or to change the delay 3 Tap to confirm and go back to the previous page ...

Page 31: ...s enabled and there is no need to enter the code again To acquire the activation code please refer to the Activation code instructions WHO CAN MANAGE USERS AND RESET THEIR PIN Only a user with administrator rights can create and delete users and reset the PIN code of a user to 0000 ADD A USER 1 On the homepage tap 2 Tap your user name 3 Enter the PIN and tap to confirm 4 Tap 5 Tap the text box a k...

Page 32: ...ILABILITY To access the user management functions the User Management activation code must be entered The activation code is required only at the first access to the User Management or the Options menus after the code was entered the function is enabled and there is no need to enter the code again To acquire the activation code please refer to the Activation code instructions WHO CAN SET THE TRACE...

Page 33: ... to the previous page Label printer selection optional FUNCTION AVAILABILITY The first time you access the Label Printer menu you will be requested to enter an activaction code To require the activation code please refer to the Activation code instructions provided with the label printer LABEL PRINTER SETUP SELECT AND CALIBRATE A LOCAL LABEL PRINTER 1 On the homepage tap 2 Tap the local printer is...

Page 34: ...required and the load has been checked and released if these options have been enabled by the administrator For the automatic label printing a maximum storage time in weeks can be set This value is used to calculate the expiry date to be printed on the labels see Label content description on the next page SET THE AUTOMATIC LABEL PRINTING 1 On the homepage tap 2 Activate Automatic printing 3 Tap or...

Page 35: ...release B Traceability code alphanumerical and bar code Released Depending on the traceability settings this field may contain one of the following elements n the user who released the cycle n the user who started the cycle n the sterilizer ID Cycle Cycle name Number Cycle number Date Date and time of cycle start Expiry date n Expiry date of the bag package n The cycle outcome if a storage time is...

Page 36: ...FORMED ON THE STERILIZER Test Purpose Reference Bowie and Dick test Validate the sterilizer performance for textile load sterilization See Bowie and Dick test below Helixtest Validate the sterilizer performance for hollow items See Helixtest on page 39 Vacuum test Validate the sterilizer performance in terms of n efficiency of the vacuum pump n tightness of the pneumaticcircuit See Vacuum test on ...

Page 37: ...on chamber except the lowest one 2 Place the Bowie and Dick test pack in the center of a tray in the lowest rack position and close the chamber door 3 On the homepage tap Helix B D test 4 To set the duration of the Plateau Sterilization phase and other settings tap 5 Tap and enter your credentials if required the chamber door locks 6 Wait until the end of the test and tap OPEN the chamber door unl...

Page 38: ...RESULT Indicator What happened Test passed What to do next The entire surface of the indicator sheet has changed colour Yes Certain ares of the indicator sheet have not changed colour since there was an air pocket during the cycle due to sterilizer malfunction No Repeat the test If it fails repeatedly call technical service ...

Page 39: ...pen 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 CARRY OUT THE TEST IN ACCORDANCE WITH EN13060 1 Empty the sterilizer chamber to ensure no load is present Remove all trays from the sterilization chamber except the lowest one 2 Unscrew the tu...

Page 40: ...er your credentials if required 10 Open the chamber door extract the tray using the tray holder and take the tube CAUTION Risk of burns The test pack is very hot at the end of the cycle Wear appropriate PPE e g gloves 11 Unscrew the tube capsule and remove the indicator strip 12 Check the change in colour See Interpret the test result below INTERPRET THE TEST RESULT Indicator What happened Test pa...

Page 41: ...otice 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 PURPOSE OF THE TEST The test is used to validate the sterilizer performance in terms of n efficiency of the vacuum pump n tightness of the pneumatic circuit DESCRIPTION It consists of a vacuum phase followe...

Page 42: ...Vacuum 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 informs if the test passed or failed If the test failed see What to do when the test failed below WHAT TO DO WHEN THE TEST FAILED 1 Check clean or replace the door gasket 2 Clean the chamber face side a...

Page 43: ...ed by chemicals PACKAGING In order to preserve sterility rotating instruments should be wrapped bagged prior to sterilization Follow the manufacturer s packing instructions when using sterilization packaging CLEANING THE INSTRUMENTS Clean all instruments thoroughly prior to sterilization If possible clean instruments immediately after use always follow the instrument manufacturer s instructions Re...

Page 44: ...out putting them on trays if size allows to enhance drying When sterilizing double decker cassettes place them in the lowest rack position as there is more space height wise Pouched items On trays allowing adequate space in between bags Ensure that packs do not touch the walls of the chamber Place sterilization pouched items with the paper side facing up Load type Placement Empty containers or non...

Page 45: ...the center of the end edge 1 and slide it outwards 2 FILLING THE CLEAN WATER TANK 1 Switch the sterilizer ON and remove the tank filling cover cap 2 Fill the clean water tank with distilled or demineralized water until the sterilizer makes a sound See Technical data on page 96 for the tank volume 3 Reposition the tank filling cover cap INSERTING THE CHAMBER RACK INTO THE STERILIZER CAUTION Risk of...

Page 46: ...oad type 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 limited load weight 0 5 kg of wrapped instruments only The ECO B option is available for the B Universal 134 and B Prion 134 cycles only WARNING For your safety and the safety of your patients never exceed the maximum load weight limits as this co...

Page 47: ... 9 If required enter your credentials and confirm the release of the load if needed SET THE STERILIZATION CYCLE START You may schedule the start of the sterilization cycles at a certain date and time e g if you want to load the sterilizer in the evening and run standard sterilization cycle early the next morning before office hours You can set the cycle start date and time and enable or disable it...

Page 48: ...cle see Sterilization cycles on page 89 4 Tap to confirm and go back to the previous page If Remember next time is selected this becomes the new fixed value VIEW THE CYCLE PARAMETERS You can check the real time cycle parameters or the cycle parameters at the end of the cycle Following is an example 1 While the sterilization cycle is running or when cycle ends tap the cycle information page opens 2...

Page 49: ...d and stock it STOP A STERILIZATION CYCLE WARNING You can stop the cycle at any time Instruments must not be considered sterile if this occurs before the DRY phase A cycle can be manually aborted at any time To stop a cycle 1 Tap STOP a confirmation request appears 2 Tap to abort the stop command The cycle continues programmed 3 Tap to abort the cycle the sterilizer starts a reset phase Notice Do ...

Page 50: ...t and the analytical reports in SCL format All parameters are recorded every second WHAT HAPPENS WITH UNSAVED CYCLES If for any reason e g USB memory full USB pen drive disconnected etc some cycles cannot be saved no alert is shown If still stored in memory the unsaved cycles will be copied in a working USB pen drive connected to the sterilizer as soon as a new cycle starts VIEW CYCLE HISTORY To v...

Page 51: ... be printed 6 Tap to save the set number for the next time 7 Tap to print the labels required SAVE ALL THE CYCLE REPORTS ON THE USB PEN DRIVE The number of reports that can be saved on the USB pen drive depends upon the USB capacity To save all the cycle reports 1 On the homepage tap 2 Tap after the confirmation all sterilization cycle reports are stored in the USB SET THE REMOTE FOLDER FOR SAVING...

Page 52: ...d enter the user name and password 7 Tap to save 8 Tap to go back to the previous page 9 To check if the parameters entered are valid see Test the data storage optional below TEST THE DATA STORAGE OPTIONAL Note The test function is available only if the remote data storage is enabled See Set the remote folder for saving the reports optional on the previous page 1 On the homepage tap 2 Tap a sequen...

Page 53: ...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 Cycle start PV1 PP1 PV2 PP2 PV3 PP3 Pressure and vacuum pulses PPH Phase of pressure rise to sterilization conditions PRS Plateau Sterilization phase start n MIN MAX temperature n MIN MAX pressure PRE Pla...

Page 54: ... RIK 1 Med ENG Rev03 11 05 2020 2020 W H Sterilization Srl 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 ...

Page 55: ...lx 15 lx 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 Notice Follow the instructions in this chapter when carrying out any maintenance on the sterilizer Ordinary maintenance MAINTENANCE BY THE USER Frequency 1 Cycles 1 Operation Monthly 50 Cleaning ...

Page 56: ... executed since the last replacement When the number of cycles is close to the maximum a pre alert about the concerned consumable is 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 not replace the consumable immediately the sterilizer will operate a...

Page 57: ...Clean the seal 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 If you use a detergent solution be careful not to get in contact with the plastic body of the front cover 2 Rinse with clean water Note when the seal is new it might be necessary to hold the door gently closed at the sterilization s...

Page 58: ...n not to bend or damage the temperature probe inside the sterilizer chamber 3 Rinse with water 4 Clean the trays the chamber rack and the steam diffuser plate with a damp sponge and a mild detergent solution 5 Rinse with water 6 Reposition all pieces of the chamber accessories properly WARNING Ensure that the steam diffuser plate is correctly placed and engaged as this is essential for the sterili...

Page 59: ...2020 W H Sterilization Srl 59 CLEANING THE CHAMBER FILTER Proceed as follows 1 Allow the sterilization chamber to cool down 2 Empty the sterilizer chamber by removing the trays and the rack 3 Turn the filter cap at the back of the chamber bottom center counter clockwise ...

Page 60: ...ev03 11 05 2020 2020 W H Sterilization Srl 4 Remove the filter cap and the cartridge filter 5 Rinse the cartridge filter with tap water 6 Insert the cartridge filter in the filter cap 7 Insert the filter cap with the cartridge filter in its original position ...

Page 61: ...erilization Srl 61 8 Lock the filter cap by turning it clockwise CLEANING THE EXTERNAL SURFACES OF THE STERILIZER Proceed as follows 1 Clean all external sterilizer covers with a slightly damp cloth moistened with water Notice Never use disinfectants detergents or abrasive products ...

Page 62: ...ER 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 56 Proceed as follows 1 Open the service door 2 Unscrew the bacteriological filter by hand counter clockwise 3 Screw on the new bacteriological filter clockwise and tighten it snug ...

Page 63: ...e 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 56 Proceed as follows 1 Open the chamber door 2 Pull out the dust filter handle from underneath the sterilizer 3 Lift the used filter from the handle and remove it ...

Page 64: ...e the handle back into its original position 6 Close the chamber door 800 cycle or biannual maintenance SEQUENCE OF PROCEDURES TO CLEAN THE WATER TANKS To clean the water tanks proceed as follows 1 Prepare the sterilizer for cleaning the water tanks on the next page 2 Access to the water tanks on the next page 3 Clean the water tanks on page 67 ...

Page 65: ...ows 1 Switch OFF the sterilizer and disconnect the mains cable 2 Completely drain both water tanks see Draining the used and clean water tank on page 73 3 To drain the detergent solution during the subsequent cleaning leave the drain tube attached to the drain port of the tank you want to clean ACCESS TO THE WATER TANKS Proceed as follows 1 Lift the water tank cover ...

Page 66: ...20 2020 W H Sterilization Srl 2 Remove the internal tank cover 3 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 ...

Page 67: ...eed as follows 1 Clean the internal tank surfaces with a soft sponge and a mild detergent solution Notice Never use disinfectants strong detergents or abrasive products Use a small non abrasive brush to clean the areas that are difficult to reach 2 Rinse the internal tank surfaces 3 Wait until the drain tube has drained all the detergent solution and dry the internal tank surfaces 4 Detach the dra...

Page 68: ... LINA Instructions for Use RIK 1 Med ENG Rev03 11 05 2020 2020 W H Sterilization Srl 5 Remove the internal filters 6 Clean the metal cartridges of the internal filters with tap water 7 Reposition the internal filters ...

Page 69: ...Maintenance LINA Instructions for Use RIK 1 Med ENG Rev03 11 05 2020 2020 W H Sterilization Srl 69 8 Reposition the internal tank cover and then the water tank cover 9 Detach the drain tube ...

Page 70: ...umable before the maintenance due date you have to reset the cycle counter See Replace the consumable before the maintenance due date on page 56 Proceed as follows 1 Fully open the chamber door 2 Remove the used door gasket by hand 3 Carefully clean the seal seat and the chamber face side with a damp lint free cloth 4 Moisten the new seal with water to facilitate its placement ...

Page 71: ...n 6 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 7 Wipe any residual water and run a Vacuum and Helix test to check for perfect tightness of the seal See Vacuum test on page 41 and Helix test on page 39 ...

Page 72: ... internal components n a check of the entire sterilizer with special care for the safety systems n the cleaning of areas and components that cannot be accessed by the user ACTIONS REQUIRED FOR EACH ELEMENT For each element the actions to carried out are the following Element Replace Clean Check Solenoid valves x Vacuum pump internal parts x Sterilization chamber and external surfaces x Chamber fil...

Page 73: ...lizer for at least seven days you have to drain the tanks 1 Open the sterilizer service door 2 Put a container below the sterilizer 5 l 1 3 gal minimum and place the end of the drain tube in it 3 To drain the used water insert the drain tube connector in the grey port 4 To drain the clean water insert the drain tube connector in the blue port 5 When the water has been completely drained press the ...

Page 74: ...de of n Drop the sterilizer with a company that specializes on the recycling of related products n Do not abandon the sterilizer in unsecured places n Always refer to current applicable laws and rules in the country of use The same instructions apply to disposal of all used consumable parts MATERIALS The sterilizer is mainly built from fiber reinforced polymers metals and electric electronic compo...

Page 75: ...cription Actions 0xx Load cannot be considered sterile See End of a sterilization cycle on page 49 Repeat the cycle If the problem persists call service Check if the mains switch or network circuit breaker is OFF Check if the mains cable is properly connected Switch the sterilizer OFF and ON Set date and time then switch the sterilizer OFF and ON Check the dust filter and ensure that the sterilize...

Page 76: ...nd the chamber furniture from residuals of detergents disinfectants and other chemicals Replace the clean water if it is suspected to be contaminated with chemicals Ensure all the load is clean rinsed and free from any chemicals before sterilizing Start a vacuum test to check the tightness of the pneumaticcircuit 18x Chamber filter clogged Remove and clean the chamber filter See error 13xto 16x ab...

Page 77: ...here are hurdles on the door locking area chamber rack loads objects Repeat the cycle If the problem persists call service Check the door gasket wrong placed Check if the door can move freely without touching the trays or the load when closing Switch the sterilizer OFF and ON 990 The cycle has been aborted by the user Re process the load MESSAGES AND ALERTS Notice For any error not listed in this ...

Page 78: ... on page 55 Bact Filter must be replaced in cycles Have you ordered the Bact filter Dust Filter must be replaced in cycles Have you ordered the Dust filter 4000 cycle maintenance must be performed in cycles Have you already booked the 4000 cycle service This pre alert advises you that the target of 4000 cycles is close and the relevant maintenance step is to be scheduled Contact your Technical Ser...

Page 79: ... you may still use the sterilizer but the message will appear again after some cycles CAUTION Operating the sterilizer with expired consumables could be dangerous and could damage the sterilizer Bact Filter replacement is due Have you replaced the bacteriological filter Dust Filter replacement is due Have you replaced the dust filter 4000 cycle service Please call your technical support to organiz...

Page 80: ...ng e g place a towel below the chamber door VIEW AND SAVE THE ERROR LOG 1 On the homepage tap a list of the last errors appears 2 Tap to save the list in the USB pen drive ERROR PAGE During the sterilization cycle the sterilizer is continuously monitored by a control system If an anomaly is detected the cycle is aborted automatically and the sterilizer starts a reset phase The following page appea...

Page 81: ...ures the error 240 or a timeout error is displayed The thermostat must 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 chamber door 4 Remove the dust filter and move the sterilizer closer to the shelf edge 5 Push the reset button of the thermostat switch a click sound indicates that the thermostat switch ...

Page 82: ... Close the chamber door 8 Connect the mains cable and place the sterilizer back into its original position 9 Switch the sterilizer ON 10 Wait for the sterilizer to finish the error reset phase and follow the instructions on the display Note If the thermostat operates repeatedly call technical service ...

Page 83: ...he chamber 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 switch is open Reset the safety thermostat switch See Extraordinary maintenance on page 73 Electric electronicfault Call technical service At the end of the cycle there is residual water in the c...

Page 84: ...m See Load maintenance and preparation on page 43 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 temperature selected Select a sterilization cycle featuring a lower sterilization temperature Follow the instructions of the instrument manufacturer The cycle report printer does not work Print...

Page 85: ...e cycle the display reads Open the door but opening the door is impossible The chamber is in vacuum due to an internal malfunction See Emergency door opening on the next page Switch the sterilizer OFF this releases any internal pressures allowing the chamber door to be opened Call technical service if the problem persists The bacteriological filter is blocked Remove the bacteriological filter to g...

Page 86: ... to serious 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 least 3 hours before executing this procedure Notice Carry out this procedure only as indicated and with the sterilizer in the indicated conditions Any attempt to open the door in a differ...

Page 87: ...20 W H Sterilization Srl 87 OPEN THE DOOR IN EMERGENCY 1 Unplug the sterilizer and wait at least three hours 2 Take the emergency door opening tool included in the sterilizer box 3 Firmly open the service door 4 Unscrew the bacteriological filter by hand counter clockwise ...

Page 88: ...W H Sterilization Srl 5 Plug two batteries into the connectors 6 Holding the service door pulled plug the plastic connector into the socket behind the bacteriological filter 7 As soon as the door opens unplug the plastic connector to prevent system overload and consequent damage ...

Page 89: ... maximum load weight limits specified in it as this could impair the sterilization process Such actions could result in non sterile conditions at the end of the cycle could expose people to the hazard of cross infections are considered as an improper use of the sterilizer for which the manufacturer cannot be hold responsible All indications of sterile load or successful completion of the cycle tha...

Page 90: ...hat cannot withstand the high temperatures of the 134 cycles such as textiles and plastics S S Naked 134 For fast processing of unwrapped instruments only including solid hollow A narrow lumen and hollow B simple hollow items It is not suitable for textiles porous or bagged wrapped items The instruments sterilized with this cycle cannot be stored they must be used immediately after being sterilize...

Page 91: ... n Hollow B simple hollow item TOTAL CYCLE DURATION The total cycle time includes the drying time and may vary according to different elements such as the following n type of load solid or porous n load weight n other factors Values and cycle names could be different depending on country requirements Load Empty Full Typical 2 5 kg Eco 0 5 kg LINA 17 LINA 22 LINA 17 LINA 22 LINA 17 LINA 22 LINA 17 ...

Page 92: ...kg 4 BPrion 134 ECOmode 0 5 kg 0 5 kg 0 5 kg 0 5 kg 0 5 kg 0 5 kg BUniversal 121 3 5 5 5 kg 1 4 0 6 0 kg 2 3 5 5 5 kg 1 4 0 6 0 kg 2 0 5 1 5 kg 3 0 5 2 0 kg 4 S Naked 134 4 0 kg 4 0 kg Note 1 Duration reported in the table refers to 3 5 kg It is possible to sterilize up to 5 5 kg by drying time extension Note 2 Duration reported in the table refers to 4 0 kg It is possible to sterilize up to 6 0 k...

Page 93: ...HE Pre heating of the sterilizer This phase is not considered a part of the cycle HEA Heating phase heat the chamber and the load PV1 PV2 Vacuum pulse removal of air from the sterilizer chamber load PP1 PP2 Pressure pulse steam generation PPH Rise to the Plateau Sterilization phase PR Process Plateau Sterilization phase DRY Vacuum drying LEV Leveling Pressure inside the sterilization chamber is le...

Page 94: ...v03 11 05 2020 2020 W H Sterilization Srl 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 ...

Page 95: ...Srl 95 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 ...

Page 96: ... to 104 F Working relative humidity Max RH 80 up to 31 C 88 F linearly decreasing to 50 at 40 C 104 F Storage temperature rel humidity From 20 C to 60 C from 4 F to 140 F 0 90 with empty tanks Max altitude 3000 m asl Min atmospheric pressure 0 6 bar 8 7 psi Overall dimensions W 465 mm H 452 mm D 646 mm W 18 3 H 17 8 D 25 4 Min space required W 485 mm H 502 mm D 439 mm W 19 1 H 19 8 D 17 3 Size of ...

Page 97: ...ENERATOR Pressure safety valve 5 bar 72 51 psi Safety thermostats 230 C 446 F DISTILLED OR DEMINERALIZED WATER Water quality Fulfilling EN 13060 Ann C conductivity 15μS cm Total Dissolved Solids 10 ppm Average water consumption 0 5 to 0 66 litres cycle 0 13 to 0 17 gal cycle Tank volume Clean water 4 8 l 1 27 gal 2 8 l 0 74 gal with air gap Used water 4 8 l 1 27 gal ...

Page 98: ...chnical data Recommendations for validation TEST VALIDATION POINTS LINA sterilizers can be validated in accordance to EN17665 1 For further details please refer to the Qualification Validation guide for sterilization cycles of the manufacturer Part Description Hottest points Coldest points ...

Page 99: ...on Srl 99 Diagrams CONNECTION DIAGRAMS Data communication Water system Note Rear serial connection Note 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 96 ...

Page 100: ...ity at 20 C 15 µs cm pH value 5 7 Contaminants minerals qualities Value Specification Appearance colorless clean free from sediment Hardness 0 02 mmol l Chemical additives No chemicals or additives must be added to the water used for the steam sterilization process even if they are specifically claimed for use in steam generators or for steam production or as additives for sterilization disinfecti...

Page 101: ...28 x312 n 188 x22 x312 F523031X Note rack rotated 90 Standard chamber rack for 3 cassettes containers for LINA 17 Usable space Cassette size mm n 190 x50 x312 n 190 x50 x312 n 190 x50 x312 Picture Part Part number Standard chamber rack for 5 aluminium trays for LINA 22 Usable space Cassette size mm n 188 x21 x400 n 188 x28 x400 n 188 x28 x400 n 188 x28 x400 n 188 x22 x400 F523032X Note rack rotate...

Page 102: ...l chamber rack for 3 cassettes containers for LINA 22 Usable space Cassette size mm n 205 x35 x380 n 210 x35 x380 n 205 x35 x380 F523021X Picture Part Part number Optional chamber rack for 4 cassettes containers for LINA 17 Usable space Cassette size mm n 190 x32 x300 n 210 x32 x300 n 210 x32 x300 n 190 x32 x300 F523012X Optional chamber rack for 4 cassettes containers for LINA 22 Usable space Cas...

Page 103: ...amber rack for 2 cassettes containers for LINA 22 Usable space Cassette size mm n 190 x70 x380 n 190 x70 x380 F523017X Picture Part Part number Optional chamber rack for 6 aluminium trays for LINA 17 Usable space Cassette size mm n 188 x19 x312 n 188 x21 x312 n 188 x21 x312 n 188 x21 x312 n 188 x21 x312 F523033X Note rack rotated 90 Optional chamber rack for 3 cassettes containers for LINA 17 Usab...

Page 104: ...ce Cassette size mm n 190 x50 x400 n 190 x50 x400 n 190 x50 x400 Picture Part Part number Optional chamber rack for 2 aluminium trays and 3 wider aluminium trays for LINA 22 Usable space Cassette size mm n 188 x22 x400 n 215 x21 x400 n 215 x28 x400 n 215 x28 x400 n 188 x22 x400 F523035X Note rack rotated 90 Optional chamber rack for 3 cassettes containers for LINA 22 Usable space Cassette size mm ...

Page 105: ... A801503X Label printer LisaSafe label printer only 19721109 LisaSafe Connection Kit n USBconnection cable n 1 roll of 2100 labels n 1 wax resin ribbon n activation code instructions 19721123 Picture Part Part number QR code Bar code reader for labels 19721132 Dist water distiller 19723101 Multidem C27 water demineralizer only with AWF kit 19723112 Osmo water demineralizer osmoticprinciple only wi...

Page 106: ...andard aluminium trays CONSUMABLES Picture Part Part number When replace it Bacteriological filter W322400X Every 400 cycles Door gasket F460504X Every 800 cycles Dust filter F364511X Every 400 cycles 400 800 cycle consumable kit Components n 1 door gasket n 2 bacteriological filters n 2 dust filters X050328X Refer to each single component above 250 helixstrips T800205X Before stocks are exhausted...

Page 107: ...ation code Description Part number Remote data storage Activates the Remote data storage 19730052 Traceability Activates the User Management and Options menus 19730055 Note use only accessories recommended by W H Authorized W H service partners A list and a map with your nearest W H service partner are available at www wh com ...

Page 108: ...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 sterilizer levelled and flat Yes No 9 Are the recommended ventilation indications of the allocated area for the sterilizer respected Yes No 10 Are the required minimum clearances respected Yes No 11 Have you explained which...

Page 109: ...each available sterilization program Yes No 24 Have you shown the head of the clinic practice how to prepare and place the load in the sterilizer chamber Yes No 25 Have you explained to the head of the clinic practice to use only original parts and accessories on the sterilizer Yes No 26 Have you shown and explained to the head of the clinic practice the safety advise section Yes No Check 27 Have ...

Page 110: ...zation Srl 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 Yes No Yes No Yes No Yes No Yes No Yes No Yes No ...

Page 111: ...INA Instructions for Use RIK 1 Med ENG Rev03 11 05 2020 2020 W H Sterilization Srl 111 Date Cycle n Operator Released Signature Chemical indicator Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No ...

Page 112: ...on forms 112 LINA Instructions for Use RIK 1 Med ENG Rev03 11 05 2020 2020 W H Sterilization Srl Date Cycle n Operator Released Signature Chemical indicator Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No ...

Page 113: ......

Page 114: ...Manufacturer W H Sterilization Srl via Bolgara 2 Brusaporto BG Italy www wh com 39 035 66 63 000 RIK 1 Med Instructions for Use ENG Rev03 11 05 2020 Subject to changes ...

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