- Dental Concepts
Contents
1. e can escape out of the chamber depending on when the program was terminated Warning m Use a tray lifter to remove the tray Never touch the sterilized items the chamber or the door with unprotected hands The parts are hot Failure to observe this requirement can result in burns Manual termination before If you terminate a program before the beginning of drying then the items to be beginning of drying sterilized are still unsterile meas A Cautionary note appears on the display The log reports that the sterilization was NOT successful Canceled by user NOT sterile Daily batch Total batches Result Never use force to open the door The autoclave could be damaged and or hot steam could escape Use a tray lifter to remove the tray Never touch the sterilized items the chamber or the interior of the door with unprotected hands The parts are hot Failure to observe this requirement can result in burns autoclave Danger f a wrapping is damaged wrap the object again and re sterilize it A m Check the wrapping of the sterilized objects for damage when removing them from the Non observance can result in unsterile instruments This endangers the health of the patient and the practice team If you remove the sterilized items from the autoclave directly after the end of the program it can happen that slight quantities of condensate moisture are found on the sterilized items Smaller quantities of water w2. time increases by about 5 minutes upon the next start depending on the length of the operating pause as the double jacket steam generator must first be pre heated to the necessary start temperature Set the energy saving mode as follows Select Settings menu gt Energy saving mode Follow the same steps as in the section for the setting Date and Time Pause times Pause times between individual programs are not required since the sterilization chamber is permanently maintained at the required temperature Longer operating pauses Keep the door closed in the pauses between the sterilizations if the autoclave is switched on This requires less energy to maintain the double jacket steam generator at the desired temperature If the pauses between two sterilizations last longer than one hour MELAG recommends that you switch off the autoclave You can save energy this way If the autoclave was switched off for one hour then it requires about five minutes in order for the double jacket steam generator to heat up again and be ready for operation If the autoclave is not be switched off during longer operating pauses the energy saving mode can be set After operating pauses which last longer than two weeks carry out a vacuum test and thereafter an empty sterilization with the Quick Program S The following situations can occur after longer pauses conductivity too high Bad feed water Change the feed water or the mixed bed resi
3. on the autoclave lower front side Only have the autoclave set up installed and commissioned by people authorised by MELAG Only operate the autoclave in areas which are not subject to explosion hazards The connections for electrical provision and water supply and discharge must be set up by trained personnel Follow the instructions of the textile and instrument manufacturers for preparing and sterilizing textiles and instruments Only use wrapping materials and systems which are suitable for steam sterilization according to the manufacturer s information Take heed that when opening the door after terminating a running program hot water steam can escape out of the chamber depending on when the program was terminated Depending on the time of the program termination the load might not be sterile Observe the clear instructions shown on the display of the autoclave If necessary sterilize the affected objects after rewrapping Never use force to open the door Use a tray lifter to remove the tray Never touch the sterilized items the chamber or the interior of the door with unprotected hands The parts are hot Check the wrapping of the sterilized objects for damage when removing them from the autoclave If a wrapping is damaged wrap the object again and re sterilize it Have the maintenance done only by authorized persons Maintain the specified servicing intervals Two people are necessary to carry the autoclave
4. 4 C 5 30 min Type B Quick Program B 134 C 3 30 min Type B max 1 5 kg single wrapped or max 6 kg 41 B or 7 kg 43 B unwrapped Quick Program S 134 C 3 30 min Type S only for unwrapped instruments Gentle Program 121 C 20 30 min Type B 134 C 20 30 min Type B Selecting the program Select the sterilization program according to how the items to be sterilized are wrapped Furthermore consider the resistance to high temperature of the items to be sterilized All sterilization programs are displayed in the menu Programs amp Tests Programs Wrapping Especially Operating Drying Load suitable for time 41 B 43 B Universal Program single and mixed loads approx 15 min 6kg 7kg multiple long narrow bore hollow 21 min wrapping body instruments j single and instruments where a approx 15 min 6kg 7kg multiple danger of infection by 38 min wrapping pathologically modified proteins is suspected e g Creutzfeld Jacob BSE Gentle Program single and textiles approx 15 min Textiles multiple Thermo instable goods 36 min 2 kg 41 B wrapping e g plastic rubber 2 5 kg 43 B articles Thermo instable Goods 6 kg 7 kg Quick Program B P single Long narrow bore hollow approx 6 min single wrapped body instruments 12 min wrapped max instruments 1 5 kg no textiles unwrapped 6kg 7kg Quick Program S only simple solid instruments ca 10 min 2 min 6 kg 7 kg L unwrapped transmission instrumen
5. MELAG Operating Manual Autoclaves of the Premium Plus Class Vacuklav 41 B Vacuklav 43 B software version 3 0 Please read this Operating Manual before you start operation of the autoclave The instructions include important safety information Make sure to keep the Operating Manual near to the autoclave It represents a component of the product We reserve the right to technical alterations C 0535 MELAG Medizintechnik oHG E Mail info melag de Geneststra e 6 10 www melag de 10829 Berlin Rev 1 11 2535 Germany Doc KBA_GB_41B _43B _v1 docx Appropriate use Power cable and mains socket Double jacket steam generator Set up installation and commissioning Preparation and sterilization of textiles and instruments Program termination Removal of the items to be sterilized Maintenance Carrying the autoclave Malfunctions Application area Sterilisation tasks Safety Instructions To operate the autoclave pay attention to the following safety instructions given below Do not sterilize any liquids with this autoclave Never damage or alter the plug or mains cable Never operate the autoclave if the mains cable or power plug are damaged Never unplug by pulling on the power cable Always take a grip on the plug When the device has been switched off the double jacket steam generator continues to be under pressure for some time Check the pressure display of the manometer located
6. Use a suitable carrying strap to transport the autoclave If repeated error messages occur while operating the autoclave turn the device off Only have the autoclave repaired by authorised persons Proper use The autoclave is intended for use in the medical field e g in clinics and in physician and dental practices According to DIN EN 13060 this autoclave is considered a Class B sterilizer It is Suited as a universal autoclave for demanding sterilization tasks For instance you can sterilize narrow bore instruments and transmission instruments wrapped or unwrapped and larger quantities of textiles Operating Manual Vacuklav 41 B 43 B A Danger Observe the following instructions for using the autoclave Do not sterilize any liquids with this autoclave It is not approved for the Sterilization of liquids Failure to observe these instructions may lead to delayed boiling damage to the autoclave and burns Views of the device Front Slot for the CF card Colour Touch Display LED status bar Door opens to the left Cap for emergency opening of the door Protective cap for manometer to display the pressure of the double jacket steam generator Mains switch concealed accessible from the side Ethernet Data connection 1 Reset button for overheating protection Quick fitting connection for emptying the storage tank Front foot of the unit adjustable Ethernet Data connection 2 hid
7. ality You can use the removable funnel insert to conveniently fill fresh feed water into the right chamber of the storage tank up to the MAX mark The internal storage tank holds maximum 5 litres This quantity of feed water suffices for up to 7 sterilizations Operating Manual Vacuklav 41 B 43 B MELAG According to whether the feed water supply comes from the internal storage tank or you have made the connection to a water treatment unit choose the following settings on the display Feed water Select Settings menu gt Water supply Select INTERNAL if the supply is from the internal storage tank or EXTERNAL INTERNAL EXTERNAL exrem if you have made the connection to a water treatment unit SAVE Emptying both chambers of the storage tank Attach the drain hose on a quick fitting connection left of the wastewater to the right of the feed water until this perceptibly engages Drain off the water into a container with at least 5 litres holding capacity To remove the drain again press the grey release knob at the quick fitting connection The hose detaches itself automatically from the connection Warning spring tension Please stand to the side of the connection when removing the hose Preconditions for commissioning Trays and accessories must be removed from the chamber after switching on the autoclave and before initial Start up The feed water supply must be secured he
8. den behind the white cover Rear NO 23 24 25 Ethernet Data connection 3 can be retrofitted Optional connection of the Flex Display Mains power cable Tank cap Safety valve chamber Sterile filter Safety valve double jacket Emergency overflow One way drain Connection pressure discharge Feed water intake for MELAdem swivelling threaded fitting for hose 8x1 alternatively straight Fan Rear foot of the unit fixed Operating Manual Vacuklav 41 B 43 B Pre conditions for the set up installation and commissioning m Only have the autoclave set up installed and commissioned by people authorised by MELAG Set up the autoclave in a dry and dustproof location The air humidity should be 30 to 60 and the ambient temperature 16 to 26 C Space requirements Vacuklav 41 B Vacuklav 43 B with Flex Display B 50 cm dimensions to upper edge of the autoclave without display The space requirements for the autoclave corresponds to its dimensions plus at least 5 cm on the side and 10 cm at the back side The autoclave should be freely accessible from above so that the built in storage tank can be filled and a good ventilation is guaranteed For a fault free operation the autoclave must be set up with a distinct tilt back Starting from a horizontal position check by using a water level at the chamber flange the front feet of the unit must be screwed out by about three rotation
9. hich may be are found on the upper side of the paper bags and clear plastic sterilization packages are unobjectionable if they dry out within 30 minutes after removal from the autoclave Storage of sterilized items The maximum storage life depends on the packaging and the storage conditions Please notice your national regulations of your country In general keep the following conditions Sealed against dust e g in a closed instrument cabinet Protected from damage on smooth surfaces Protected from excessive fluctuations in temperature Protected from moisture e g alcohol disinfectant Storage duration in accordance with the type of package wrapping MELAG Operating Manual Vacuklav 41 B 43 B Batch documentation The batch documentation is indispensable as documentation for the successfully completed sterilization process and as an obligatory measure of quality assurance The capacity of the internal storage suffices for about 100 logs If the internal log memory becomes full and at least one log has not been issued via an activated outmedium the following warning will appear on the display Internal program log is almost full If this cautionary warning appears you should prepare the output media determined in the Settings menu gt Logging and output the respective logs menu Logs You can store the logs of the completed programs on the following output media and archive them accordingly MELAflash CF card A comp
10. n pellets for a MELAder unit Despite running motor the door does Door seal is sticking Switch the autoclave off and pull vigorously at the door After pauses carry out the tests described below depending on the pause duration 13 Operating Manual Vacuklav 41 B 43 B 14 Checks in daily operation Vacuum test Use the vacuum test to check the autoclave for leaks in the steam system Conduct a vacuum test weekly in routine operation at initial start up after pauses longer than two weeks and in case of error Bowie amp Dick test With the Bowie amp Dick test you can verify the autoclave for sufficient steam penetration of porous sterilizing materials e g textiles For this purpose it is especially recommended when sterilizing larger quantities of textiles Conductivity measurement The conductivity measurement is used for manually measuring the quality of the feed water At the given point in time the autoclave outputs an appropriate message automatically if the permissible value was exceeded Malfunctions Error messages are displayed if safe operation or sterilization security is not guaranteed These can appear on the display shortly after switching on the autoclave or while a program Is running Follow the operating procedures shown in the connection with a warning text or an error message on the display After that you can continue the operation of the autoclave Only if the messages appear repeatedly turn to yo
11. ogs from a defined time period e g daily monthly etc or specific log types can be found here such as the option to delete logs Log output various settings can be made e g date and time brightness etc In addition standard log settings for log output can be set here Settings indicates information regarding software version and device dates e g batch lot maintenance counter log settings log memory and other technical values Info status window Service area only for technicians depending on the selected window and control status gives information for control or function of the actual window Door open opens the autoclave door Help menu Back changes to the previous window Forward changes to the next window Terminate go returns to the superior menu closes the window without saving back without saving indicates additional details e g additional values after the end of a program run Zoom Pre selection changes to the pre selection start time menu start time Delete deletes logs irretrievably Find finds the label printer s log printer s S000 Doae MELAG Operating Manual Vacuklav 41 B 43 B LED status bar The status bar located on the border of the display indicates colours for various situations e g in Standby during the running of a program or for warning or malfunction messages blue Standby program is running drying has not yet begun green drying i
12. power supply of the autoclave must be assured Record of installation and setting up ms NOTE As documentation of proper setting up installation and setting up as well as for your warranty claim the record of installation must be filled out by the person responsible and a copy sent to MELAG The control panel The control panel consists of a coloured 5 inch Touch Display Status bar 389 102 Programs amp Tests 1 2 12 12 01 11 2010 Menu bar al Va Ko ra Universal Program Vi Quick Program S 134 C 2 1 bar 5 30 min Prion Program instruments textiles wrapped amp unwrapped Quick Program B Main display Gentle Program Action bar lt A Operating Manual Vacuklav 41 B 43 B Programs Tests fal Immediate output A Additional drying pe Graphic logs Energy saving EA mode EJ Service area O CF card status indicates a program test is running indicates whether immediate output is activated deactivated indicates whether supplement drying is activated deactivated indicates whether recording of graphic logs is activated deactivated indicates whether autoclave is in energy saving mode indicates whether a service technician is logged in to the service area indicates whether a CF card is inserted and whether read or write access is in place Programs Tests all sterilization programs and tests are found here e g vacuum test Bowie amp Dick Test etc the entire log list l
13. rinter enables the traceability of the batch with details of the serial number of the autoclave sterilization date storage duration batch number user ID for the person who released the instruments the patients sterilized instruments and the sterilization batch can be easily be associated with the autoclave used and the file name under barcode Flawless packaging with the sterilized items is identified following sterilization with a raised sticker In this way the requirements for a proper release are fulfilled by the person entrusted with the preparation Thus all information about the correct sterilization of the used instruments is associated with the patient s file Additional information on the output of labels please refer to the User Manual MELAG Operating Manual Vacuklav 41 B 43 B Energy saving mode a AA am Ifthe autoclave is not be switched off during longer operating pauses the energy saving mode can be set Two waiting times can be set in energy saving mode Engy svng mode W PA Waiting time 1 W1 After a pre set waiting time of 15 minutes the temperature of Wi Temp to 109 C the double jacket steam generator will sink to 103 C The program run time 60 Min becomes about 2 minutes longer upon the next start W32 No preheating Waiting time 1 W2 After a pre set waiting time of 60 minutes the double jacket steam generator is no longer heated Accordingly the length of the program run
14. s for the Vacuklav 41 B and five rotations for the Vacuklav 43 B Establishing connections Electronical connection Electric circuit with 220 240 V max voltage range 207 253 V and 50 60 Hz at least 13 A separate fuse protection Protection from leakage current 30 mA Waste water drain You can optionally connect the autoclave via the pressure realease connection or via the one way drain directly to the outflow Follow the instructions in the Technical Manual Sg NOTE a The drain must be located at least 30 cm beneath the autoclave and be installed dip free with continuous descent Supply with feed water The autoclave works in the gentle yet effective one steam way water system This means that it uses fresh purified feed water for every sterilization run for the steam generation For this purpose the autoclave gets the feed water either from the internal storage tank which the practice team has refilled e g with distilled water from the MELAdesf65 Or it gets the feed water fully automatically from the water treatment unit MELAdem 40 or MELAdem 47 The feed water must have a quality at least to VDE 0510 or DIN EN 13060 appendix C If you employ the internal storage tank for the feed water supply you must fill it manually from time to time At the given point in time the autoclave outputs an appropriate message Fill up the storage tank Fill up the internal storage tank with fresh purified feed water of the respective qu
15. s running program completed successfully yellow for warning messages during access of the CF card red for malfunction messages program not completed successfully Prepare items to be sterilized A significant prerequisite for safe disinfection and sterilization of sterilizing materials is the appropriate preparation i e cleaning and maintenance of the sterilizing materials according to the manufacturer s instructions Furthermore the materials cleaning agents and processing procedure employed are of significance Sg NOTE If possible sterilize textiles and instruments separately from each other in separate sterilization containers or sterilization packages This way you achieve improved drying results Load the autoclave Only if the autoclave is properly loaded can the sterilization be effective and the drying deliver good results E NOTE Use perforated trays made of aluminium such as the trays from MELAG Only this way can condensate run off If you use closed materials or shell halves to bear the items to be sterilized you risk bad drying results Please note that the use of tray insertions made of paper can perhaps likewise lead to worse drying results f Employ only packaging materials and systems sterile barrier systems which satisfy the DIN EN ISO 11607 1 Standard e g Standard tray cassettes or transparently wrapped Warning sterilization packages Closed sterilization containers Preferably use sterili
16. symbol to delete the user A warning message follows When you confirm with YES the PIN for this ID is set to 0 At any time a new PIN can be set for this user ID According to RKI Robert Koch Institute Recommendations for hygiene in the preparation of medical products the preparation of instruments ends with the documentation of release to storage and use of the sterilized products The release process is comprised of the batch indication and the batch release and must take place by authorised and qualified personnel Batch indication This includes the review of the indications shown during the sterilization program e g MELAcontro e MELAcontro Pro Only once the indicator stripe has completely changed colour can the release of the indicator occur Batch release This includes the review of the process parameters with reference to the Sterilization results in the autoclave and the sterilization log as well as the review of the single wrapping for damage and residual moisture The release of the batch and the potential indications shown during the process are documented on the sterilization log Depending on the setting in the user administration the release of the sterilized items requires a user PIN from the person who releases the batch and the indications Reliable traceability by the output of labels MELAG 41 B 201041 B1000 20 10 2010 20 04 2011 Charge 01 00561 ID 1002 Cat eR Ss Prk The use of a label p
17. t User administration To getto User administration and make the settings there you must enter the Admin PIN Enter the Admin PIN Standard 1000 and confirm by pressing LOGIN The display changes to the User administration window Press continue to user list to see the user list To set a new user select an open ID and select EDIT Note that the first ID is reserved for the Admin PIN Enter a 4 digit PIN for the selected user ID in the right keypad and confirm with SAVE With SAVE you apply all settings and leave the menu By pressing the symbol 2 you leave the menu 11 Operating Manual Vacuklav 41 B 43 B 12 ID 1001 PIN 9999 ID 1007 PIN 5555 ID 1013 PIN 0 PIN 2135 ID 1008 PIN 65655 ID 1014 PIN 1234 ID 1003 PIN 7890 ID 1009 PIN O ID 1015 PIN 3456 1D 1004 PIN 0 ID 1010 PIN 0 ID 1016 PIN 5678 ID 1005 PIN 3333 ID 1011 PIN O ID 1017 PIN 3897 ID 1006 PIN 4444 ID 1012 PIN D ID 1018 PIN 1299 O a 5 EDIT amp Changing the Admin PIN To delete a user from the list Release process ao Specify the options for logging Graphic logs Batch indication Batch release Immediate output CONTINUE The Admin PIN Standard 1000 is used in the same manner as all other user PIN and should be changed on handing over Select the User administration menu as described above and open the user list Select the user ID that you wish to delete Select the
18. ts no textiles simple hollow body instruments without drying full load in the Vacuklav 41 B 6 kg Vacuklav 43 B 7 kg and depending on the load and installation conditions such as the cooling water temperature and supply voltage Operating Manual Vacuklav 41 B 43 B Auxiliary programs ee Vacuum test I For measuring leak rate a test for dry and cold device test without load Bowie amp Dick test Steam penetration test with special test package available from your specialist dealer For manually measuring the quality of the feed water For draining and pressure release of the double jacket steam generator e g for service for maintenance or before transport Starting the program If you have selected a program it is displayed marked grey You can now activate it by pressing the START key With correct loading the program specific drying times guarantee adequate drying of the sterile equipment For difficult drying tasks you can extend the drying time of a program by 50 with the function Additional Drying in the menu Settings with the option Additional drying J Pre selection start time The function start time pre selection enables you to select any program and start it at a time of your choice After selecting the program touch the amp symbol in the action bar The display changes to the Pre selection window For example to change the time tap the Hour or Minute s
19. ur specialist dealer or the authorised MELAG customer service centre in your vicinity
20. uter in a user network LAN Log printer MELAprint 42 Please learn from the operating manual of the respective device how to connect the additional devices and which settings you take at the autoclave Setting the date and time Date and time of the autoclave must be correctly set for proper batch documentation Ensure that you take into account the clock change in autumn and summer as this is not adjusted automatically E A kah Eo a o m Select Settings menu gt Date amp Time Directly select the parameters you wish to change Day month year or hour minute second The selected field will become light blue Use the and buttons for each parameter value Repeat the steps for all parameters which you want to change Confirm the modification with SAVE The display will restart after saving and then automatically return to the Program amp Tests menu For reliable traceability of the release process following the end of a sterilization program each user can be given a unique ID and PIN with which the user can authenticate before release of a batch You can determine if authentification of the user with a PIN input is required in the User administration window by checking the box for Release process with PIN User administration If this option is activated the user ID and the result of the release process are recorded in the log header To set up a new user read the following Select Settings menu g
21. ymbol The selected Universal Program 19 s 11 201 0 a r field will become light blue mn wa aurem You may now change the time by pressing the and buttons Finally press START The display will remain in the pre selection start time une lt s NOTE Please note that the function pre selection start time is not possible with the Quick Program S for safety reasons After setting the program start time no other menu can be selected other than the menu Info amp Status The start time pre selection is only active for the unique time and program selection That means that after completion of the program the pre selected start time is deleted You may turn off the autoclave while the pre selection start time is running However the autoclave must be turned on again in time for the timer to progress again m Unsupervised operation of electrical devices including this autoclave at the operator s risk MELAG accepts no liability what so ever for any damage resulting from unsupervised operation Warning Operating Manual Vacuklav 41 B 43 B 10 Manual program abort You manually terminate a running program in any of the phases To terminate a running program press the CANCEL button and confirm with YES After a short time as shown on the display you can open the door by pressing the J door symbol j m Take heed that when opening the door after terminating a running program hot water steam
22. zation containers made of aluminium Aluminium conducts heat well and thus accelerates drying Stack sterilization containers Stack on top of each other if possible only sterilization containers of the same size and with respectively identical spacer feet where the condensate can run off on the side at the walls Soft sterilization wrapping Soft sterilization packages can be sterilized both in sterilization containers on trays or standing when using a package holder do not place several soft sterilization wrappings flat on top of each other on the trays or in a sterilization containers Multiple wrapping The autoclave functions on the fractionated pre vacuum method This permits the use of multiple wrapping Mixed loads For sterilizing mixed loads observe the following instructions Always place textiles on the top Sterilization containers at the bottom Unwrapped instruments at the bottom Transparently wrapped sterilization packages and paper packaging on the top exception in combination with textiles on the bottom Stack transparently wrapped sterilization packages if possible edgewise in such a way that alternately paper side lies on paper side and foil side on foil side if this is not possible then with the paper side facing downwards Operating Manual Vacuklav 41 B 43 B Overview of sterilization programs Programs Sterilization Sterilization Program type as per DIN EN 13060 temperature time Universal Program 13
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