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Melag Vacuklav 41B,43B - User manual

1. 39 Oil door Spindle nsaisan 40 Maintenance iniiai ipinia 40 Chapter 7 Operating pauSes ssseeeeeeee 41 Sterilization frequency cc cccceeeeeeeeeeeeeeeetees 41 PaUSO tiIMOS EA EE E E EES 41 DeCOommisSioning ccccceeeeeeceeeeeeeseeeeaeeeees 42 WWANSPOMs EE A ETE dels asada EET 42 Re commissioning after change of locality 43 Chapter 8 Function teSt cs cccssseeeesees 44 Automatic function test 44 Manual function test eeen 44 Testing in daily operation 44 Vacum testei ai 44 Bowie amp Dick test 45 Validato siisii pisirin piunt renidens 45 Chapter 9 Errors csscsseesseeseseessseeeeseesseeeseee 46 A warning is not an erfor Lecces 46 MGSSAQES et ua ieron sai reae ea eae EKETE iiias 46 Warning MESSageS ee eerren 46 Error Messages wisccceescuccetecbedcdeseeeecetcssadtccreensentesese 46 Before you Call ccccccecececeseeceeeeceeeeeeeeneaeeeeess 47 Bad drying results reer 50 GOSS ANY eeestis e sassone tenets as aE ns 51 Appendix A ACCeSSOT eS nnnennnnnnennnnnnnnnnn 54 Appendix B Symbols on the autoclave 55 MELAG Chapter 1 Performance Specification In this chapter you learn under which conditions and for which purpose you should use this autoclave what benefit you can achieve by using this autoclave which sterilization programs you can use Application area Sterilization tasks Danger
2. User Manual Autoclave Vacuklav 41 B Vacuklav 43 B Dear doctor We thank you for your confidence demonstrated by the purchase of this autoclave Over 55 years ago MELAG began as a medium sized family run enterprise to specialise in the manufacture of sterilization equipment for medical practices In the meantime our company has grown into one of the world s leading producers of sterilization equipment Verification of it success has been the sale of more than 410 000 MELAG units worldwide attesting to the high quality of our sterilizers which are exclusively made in Germany This autoclave has also been manufactured and tested according to the most stringent quality criteria Nevertheless please read the Operating Instructions carefully before the initial start up of the device The long term serviceability and the retention of value of your autoclave depend primarily on the careful preparation of the instruments and the regular maintenance of the device MELAG General Management and employees For physicians physician s assistants and service personnel Please read this User Manual before you start operation of the autoclave The instructions contain important safety precautions Make sure to keep the User Manual near to the autoclave The instructions are a part of the product User Manual Vacuklav 41 B and Vacuklav 43 B MELAG Medical Technology Berlin Valid for Vacuklav 41 B Vacuklav 43 B as of software ver
3. sterilized items the chamber or the door with unprotected hands The parts are hot In case of non observance you can suffer burns 26 Chapter 4 Sterilization MELAG Danger Condensate residues on the sterilized items Storage conditions Storage time m Check the wrapping of the sterilized objects for damage when removing them from the autoclave m If awrapping is damaged wrap the object again and re sterilize it 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 According to DIN 58953 Part 7 smaller quantities of water which 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 Only wrap items to be sterilized in wrappings that comply to the standards Do not store sterilized items in the preparation room For the storage of the sterilized items observe DIN 58953 Part 7 and the mentioned criteria below 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 alc
4. Attention Universal use Large quantities Small time expenditure No pause times Overheating protection Clean feed water Proper use The autoclave is intended for use in the medical field e g in general 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 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 In case of non observance the consequences could be delayed boiling damage to the autoclave and burns m Use the autoclave only for the intended purposes outlined in the related technical documents and only in connection with the devices and components recommended by MELAG m The sterilization of instruments and textiles with this autoclave like the foregoing instrument sterilization is only to be done by competent personnel m Only use instruments wrappings and textiles which are suitable for steam sterilization according to the manufacturer s information In case of non observance the consequences can entail damage to the autoclave and or to the items to be sterilized User benefit The autoclave sterilizes on the basi
5. at initial commissioning after pauses longer than two weeks and in case of error Automatic function test The interaction of the sterilization relevant parameters of pressure temperature and time are continually automatically monitored by the electronic parameter control The process evaluation system of the autoclave compares the process parameters with each other during the program and monitors them with respect to their limit values The monitoring system of the autoclave checks the device components with regard to their functional reliability and their plausible interaction If the parameters exceed defined limit values the autoclave outputs warning messages or error messages If necessary it aborts the program with a corresponding notice If the program was successfully concluded an appropriate message is issued on the display Manual function test You have the possibility of tracking the program sequence based on the values shown on the display By pressing the DETAILS button you can view additional information about the currently running program Furthermore based on the logs recorded for every program you can logically reconstruct whether a program was successful see page 28 Chapter 5 Logging Testing in daily operation Observe the manufacturer s recommendation from MELAG on the routine operations of Class B autoclaves according to the recommendations of the Robert Koch Institute from April 2006 Vac
6. the water treatment unit Transport Carrying the autoclave Observe the following when carrying the autoclave m Two people are necessary to carry the autoclave m Use a suitable carrying strap to transport the autoclave Danger m Make sure that the distance between the housing floor plate of the autoclave and setup location is small In case of non observance spine damage and contusions can result Transport over larger To transport the equipment for instance to remove or ship the autoclave distances shipping observe the following To transport over a longer distance and or when danger of frost Attention and or to ship the unit an authorized person must prepare the autoclave according to instructions and completely empty the double jacket steam generator see Empty double jacket In case of non observance damages to the autoclave and errors can occur Transport within the medical Observe the following for transporting the autoclave within a room or practice within the practice Chapter 7 Operating pauses MELAG Attention Empty double jacket Proceed as with the initial commissioning m Before you move the autoclave wait after switching off the power until the manometer for the pressure display of the double jacket steam generator page 7 Figure 1 4 shows zero bar m Close the water feed and remove the hose connections at the rear of the device m If you would like to leave the mounting
7. 217 064 clock Program course last program Universal Program Plateau time 05 30 min Chamber temperature 99 7 C Chamber pressure 0 00 bar Vacuklav 41 B 200341 B1333 Fertig Air is repeatedly evacuated in the evacuation phase until a program dependent pressure is achieved This occurs in alternation with the inflow of steam up to a slight overpressure After achieving the sterilization parameters of pressure and temperature the sterilization phase begins The sterilization time is shown on the display There is a pressure discharge at the end of the sterilization phase The drying phase begins after the pressure discharge The regular drying time for the quick program S is two minutes for the quick program B six minutes and for all other programs 15 minutes Chapter 4 Sterilization MELAG Manually terminate program Danger Manual termination before beginning of drying 06 20 2006 SU A pressure exhaust after 11 40am cancel 120 29 Program cancellation Please wait Universal program Chamber temperature 83 6 C Chamber pressure 0 61 bar Cancel by user Load not sterile DETAILS Manual termination during drying Sterilization successfully finished 06 20 2006 STO1 Drying 1st vacuum drying 11 36am 117 303 Universal program running Drying immediate removal with STOP Chamber temperature 67 9 C Chamber pre
8. 29 Plug in and remove CF card Change to the DOCU Menu and from there save the desired logs on the CF card see page 32 Subsequent output of stored logs Reformat the CF card At the computer transfer logs from month directories into newly created directories Repeat vacuum test if autoclave is cold dry and empty Call MELAG customer service or specialist dealers and make a maintenance appointment autoclave can continue to be used Connect printer see page 33 Use log printer as output medium Read out the internal log memory on the storage medium of your choice with the DOCU menu see page 33 Subsequent output of stored logs WMS8 Autoclave internal memory for the error logs is almost full Error logs are required by the technicians for maintenance and fault analysis Read the internal error log memory to a storage medium of your choice with the Docu Menu WCF8 In the SETUP Menu immediate output Press YES if you now would like to output is set to YES and the CF card is the still not outputted logs to the CF card activated as the output medium but was previously not plugged in WPR8 Immediate output is set to YES in the Press YES if you now would like to print the SETUP Menu and the printer is activated as logs still not printed out output medium but was previously not connected WPC8 Immediate output is set to YES in the Press YES if you now would like to output SETUP
9. Sterilization MELAG Textiles Danger Instruments Danger Observe the following instructions for treating textiles and putting the textiles into sterilization containers Comply with the instructions of the textile manufacturer for treatment and sterilization and observe relevant standards and directives e g of RKI and DGSV Adjust the folds of the textiles parallel to each other m Stack the textiles in the sterilization containers vertically if possible and not too closely together so that current channels can form m Retain the vertical stacking method when you pack the textiles in sterilization containers m If textile packages do not stay together wrap the textiles in sterilization paper Sterilize only dry textiles m The textiles may have no direct contact to ground and walls of the sterilization chamber otherwise they absorb condensate In case of non observance the steam penetration of the washing packet can be obstructed and or bad drying results can result In that case the textiles cannot be sterilized which can entail endangerment to the health of the patient and the practice team Observe the following instructions for treating used and brand new instruments m Follow without fail the instructions of the instruments manufacturer for treatment and sterilization and observe the relevant standards and directives e g of gt BGV A1 RKI and DGSV m Clean the instruments very thorou
10. a program Inthe menu SETUP menu gt 02 Automatic logging gt Immediate output set to YES Inthe SETUP menu gt 02 Automatic logging at least one output medium is set to YES and automatic logging is thus set as ACTIVE The activated output medium is attached protocol printer MELAprint 42 or Plugged in MELAflash CF card If the protocol automatic is unable to issue a log for example because the output medium activated is not connected a warning will appear The autoclave registers as yet not issued logs for every output medium It provides the option of issuing this log at the next possible time MELAG recommends using the Automatic logging with immediate output of the logs corresponding to the state of delivery The following requirements must be fulfilled in order to record graphic protocols in real time Inthe SETUP menu gt 02 Automatic logging gt with navigation keys for the graphic logs atleast one output medium must be set to YES Atleast one of the selected output media corresponds to an output medium for the text log The activated output medium is attached computer or plugged in MELAflash CF card Explanation of the possible settings for graphic recording CFC recording interval in sec indicates the time intervals in which the program curve is recorded on the CF card The smaller the time interval the more exact the curve In the example the time interval is set at 1 sec
11. and the trays or cassettes in the chamber during transport protect the surface of the door plate Lay a piece of foam plastic or bubble wrap between the door plate and mounting m Close the door of the autoclave before you move the device In case of non observance damages to the autoclave and errors can occur You have the option of draining the water in the double jacket steam generator easily via the program Draining inthe SPECIAL menu In order to do so the autoclave is heated once building up pressure in the double jacket so that the water can be drained fully from the double jacket steam generator Switch off the autoclave in the program end graphic Drainage completed so that the autoclave does not feed water back into the double jacket Re commissioning after change of locality For re commissioning the autoclave after a change of locality proceed as for an initial commissioning see page 15 Chapter 3 Initial commissioning 43 MELAG 44 Chapter 8 Function test In this chapter you learn How the autoclave automatically carries out the function test Which possibilities you have for the manual function test Which function tests should be conducted in daily operation Why and how you should conduct a vacuum test Why and how you should conduct a Bowie amp Dick test Process evaluation and monitoring system On the display and based on the logs E a Weekly in routine operation
12. are shown here in case of a edk etm etd etp etv ett ENDE malfunction The values are helpful for the technician gt gt Never change code in following row lt lt Authenticity proof A000000500A7018953C9030704D6043231A43490 Should never be changed permits inference that the data gt gt Proof of veracity batch log files lt lt Was created and not changed on an autoclave from MELAG Table 15 Example of a program listing for a successfully concluded Quick Program B Log types Apart from log files for successfully concluded programs there are diverse other log types You can likewise output these with the selection list of the DOCU Menu You recognize the type of log record by its file name extension Chapter 5 Logging MELAG Table 16 Possible log file extensions Directory name log file name Subdirectories Log output Log output on the CF card Log output on aPC fae Multiple output of log files Extensio Stands for Explanation n PRO Program log file Log of a successfully concluded program GPD Graphic log Log in which the sterilization processes are recorded graphically STR Fault log Log of a terminated program STB Error in standby Log of errors without a program running LOG System log Listing of all errors and modifications of the system that occurred in temporal sequence logbook STA Status log Summary of all important settings and system status state
13. by batch Key 2 by date Key 3 by program Key 4 by success see page 33 Logging list Press key 1 for longer Additional drying see page 23 Additional than one second drying Press key 4 START Pre selection start time see page 23 for longer than one second Briefly press key 2 and 01 MELAG Vacuklay 41 B Year 2006 3 simultaneously O2 Serial No 200641 651333 03 Maint counter 120 Day 05 05 06 04 Batches Day 5 all 5 5 05 internal storage 10 tree 106 06 output media automatic logging not yet f already 09 Conduct 11 Siem 11 11 Rins wal 499 pShicm 991 333x Version Sotwaremodule Updatetile Date 11 V2 431 Firmware CPW Mov 21 2008 10 23 41 12 72 430 Parameters P4 B 26 41 2008 13 Y24431 BO BUS B1L 62L 911 12 06 14 Display Fv DFW Feb 24 2006 09 41 35 15 V2 420 Display symbols DS 08 22 2008 16 17 02 ANALOG DIGITAL Status display Display automatically returns to the previously displayed screen after 30 seconds Press key 3 Displays details to the currently running program Table 5 Important Hot Keys Acoustical signals Time delay Buffered entry Diverse messages Messages Dx Warning messages i When you press a key your entry is confirmed by a short acoustical signal There can be a very brief time delay between pressing a key and the corresponding display Despite this time delay you can press the keys qu
14. legend is a component of the most extensive logging format 0002 It serves for the designation of the program steps to which the specified values refer In digitally outputted logs CF card PC the legend is directly next to the values of the respective program step Every legend line thereby refers to the line just to the left of it For logs which are outputted to the log printer MELAprinf 42 the appropriate legend line is always below the line to which it refers Chapter 5 Logging 36 ae ge Pe EE ee TE PE PE PEPE PE PE ET Header eo ss 10 Type of the autoclave 15 Program Quick Program B 15 Program name 20 Program type 134 C 1x wrapped 20 Sterilization parameters of the program 25 Date 20 01 2009 25 Date 30 Daily batch 02 Whole 00301 30 Day and total batch number 40 Quick Program B successfully ended 40 Control message Ag SS 42 Program termination by in case program not Foe ee ee see a oa ale Gee successful 45 Temperature 135 3 0 11 0 16 C 45 Sterilization temperature with max deviations 50 Pressure 2 17 0 01 0 01 bar 50 Sterilization pressure with max deviations 55 Plateau time 03 min 30 s 55 Sterilization time G9 Sender in tye Gero 2490p 60 gt Conductivity of the feed water 65 Start time 1022915 70 End time 10 46 03 16 48 min 65 Time at start of the program 70 Time at finish of the program 80 SN 200741 B1224 80 Serial number of the autoclave 81 FW v2 431 Nov 28 200
15. notification appears on the display Look at the log header on the Before you open the door you can look at the header of the log of the just display finished program on the display To do this press DOKU Automatic logging With activated automatic logging the log of the completed program is outputted to the activated output media see page 28 Chapter 5 Logging Display batch number In the final screen after a You see on the display the daily and the total batch number after a completed program completed program This is also shown if the program was terminated by the operator or aborted by the system 122 31 Program successfully ended Universal Program Daily batch 3 12 11 2008 total batch number 01398 Remove sterile materials CAUTION Chamber door and sterile materials are hat About DOCU in the log As described above after a completed program you can press on DOCU before the door is opened This activates the display to show the header of the log of the completed program The log contains the daily and the total batch number You will naturally find this number also in the header of the stored or printed logs Remove sterilized items After the end of a program observe the following instructions for removing the sterilized objects m Never open the door by force The autoclave could be damaged and or hot steam could escape Danger m Use a tray lifter to remove the tray m Never touch the
16. 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 m Comply with the predetermined maintenance intervals Two people are necessary to carry the autoclave Use a suitable carrying strap to transport the autoclave m If repeated error messages occur while operating the autoclave turn the device off m Only have the autoclave repaired by authorized persons Safety instructions Contents Chapter 1 Performance Specification 3 Prop i USE asar a a ase aA aA E eTR EAEAN ATRE 3 User b nefit s seri aria a a 3 Overview of sterilization programs 5 Chapter 2 Device Description csseeee 6 Scope of delivery i iiicsiisiideieeiieiii diini 6 Equipment V EWS ccceeeeseeeeeeeeeeeeteeeseenaeeeenneeeeee 7 Effective capa ityis niniak 8 Mountings for the load neee 8 Switch on autoclave 9 After switching On ci eeeeeeeeeeeeeenneeeeeeeeeeeenneeeeee 9 Control panel siic een ean 10 Acoustical signals ccc cccecteeeeeeeeeseceeeeeees 12 Overview of menus and symbols 13 Supply with feed water seee 14 Close the O08 o sivsice cesses ade 14 Chapter 3 Initial commissioning 0 15 Conditions for setting up installing and COMMISSIONING sii a a ea 15 Set up location requirements 15 Connections required eeens 16 Prerequisites f
17. read how you can output all stored logs onto the CF card Prerequisite is that the CF card is plugged into the card slot Use the navigation keys to go in the main menu to the symbol for the SPECIAL Menu Press SELECT The SPECIAL Menu is opened Inthe SPECIAL Menu go with the navigation keys to the symbol for the DOKU Menu Press SELECT The DOCU Menu is opened Onthe display appears Output of stored logs on and below presented in inverse an output option Press EDIT until CF card is shown as output medium Press CONTINUE Chapter 5 Logging MELAG 13 Status log akl 14 Syster log 15 CF Card formatting 499 164 01 Logging list 02 Last log 03 Daily log file 04 Log files of the week 05 Log files of the month 06 All program logs DF Last error log 08 Error logs for the day kd BACK SELECT oO E oo o Output of stored logs on Log output options n the selection list go to the menu item All program logs Press SELECT Press OUTPUT At the display the notification Log output is shown and the LED to the right next to the card slot lights up For the output of a log record onto the CF card the autoclave requires about four seconds If the log memory is full the output of all logs can take up to four minutes Press CONFIRM twice in order to return to the SPECIAL menu Go to the symbol for CONFIRM to the Main menu and press SELECT The m
18. steam generating system the autoclave requires about three litters feed water The power supply of the autoclave must be assured If available the MEALflash gt CF card should be plugged in the card slot Installation and installation report As documentation of proper setting up installation and commissioning as well as for your warranty claim the record of installation must be filled out by the person responsible and a copy send to MELAG 17 MELAG 18 Chapter 4 Sterilization In this chapter you learn which prerequisites you must create for successful sterilization what you should observe on preparation of the items to be sterilized how you correctly load the autoclave which programs you should use for what how you start a program which stages a program runs through how to cancel a program how you can recognize that the sterilization is successfully finished what you can do to improve the drying results what you must consider when removing the items to be sterilized Create prerequisites You create the prerequisites for a smooth and successful sterilization process as follows Provide cooling water z Provide feed water n Switching on Plug in CF card If the spigot for the cooling water inlet of the vacuum pump is closed open the tap If you are employing a water storage tank for the feed water and the filling level lies below the MIN marker on the cani
19. the feed water required for generating the steam for the autoclave The purified feed water connection for the autoclave is directly connected to the water treatment unit If you use a water treatment unit then there is always sufficient feed water available You no longer need to fill the water storage tank The water treatment units MELAdem 40 and MELAdem 47 produce the optimal purified feed water quality for the autoclave The selection of the respective unit depends on the number of sterilizations per day and the respective loads Every MELAG autoclave can be supplemented with a water treatment unit Please first consult with MELAG if you would like to use water treatment units from other manufacturers Close the door When closing the door of the autoclave observe the following instructions m Do not press the door too hesitantly against the autoclave housing m Hold the door pressed closed for at least 3 seconds m Under no circumstances should you slam the door shut If you don t observe this instruction you may impair the functional reliability of the door lock mechanism The autoclave has an automatic motor driven door lock with threaded spindle In order to lock the door press it tightly closed The door locks pressure proof once the program is started Inputs at the display of the autoclave are only possible when the autoclave door is locked Leave the door open only for loading and unloading the autoclave If y
20. the report immediately select OUTPUT The output medium defined in the SETUP menu under automatic logging is then used If you would like to check which storage media are activated Chapter 5 Logging MELAG Capacity of the internal log memory B114T Warning log file storage full W372 Internal memory of the autoclave is full hot the CF Card and the output media selected for the batch documentation have not received all log files Please make media available Now you can transmit for the last time with OUTPUT the still missing log filles Then with the exception of the last 40 files the log files are deleted Sepen RESET OUTPUT CF card as output medium cae Attention Plug in CF card briefly press the keys 2 and 3 simultaneously to permit viewing of the status at the display You can output logs subsequently with the DOCU Menu There are many diverse possibilities for reading out the internal log memory You can output all stored logs on media selected for automatic logging or to some other media see page 32 Subsequent output of stored logs The capacity of the internal storage suffices for about 120 logs If the internal log memory is almost full and at least one log has not yet been issued to an activated medium the cautionary warning Internal memory of program logs almost full appears on the display If this cautionary warning appears you should prepare the output media deter
21. the sterilization be effective and the drying deliver good results Place trays or cassettes in the chamber only with the accompanying mounting Use perforated trays such as the trays ffom 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 The correct use of suitable wrapping is important for the success of the sterilization Only use packaging materials and systems which satisfy the DIN EN 868 standard You can employ recyclable rigid packaging such as Standard tray cassette or soft packaging such as Transparent sterilization packages paper bags sterilization paper textiles fleece Use sterilization containers made of aluminium Aluminium conducts and stores heat well and thereby quickens drying When using closed sterilization containers observe the following instructions for bearing the gt sterilizing materials m Closed sterilization containers must be equipped at least on one side possibly below with perforations or valves Non observance leads to insufficient steam penetration which could make the sterilization ineffective Furthermore the condensate drainage is prevented and bad drying results are the consequence This can ultimately lead to unsterile instruments and thereby to the endangermen
22. the surrounding surfaces must be at least 5 centimetres on both sides and 10 centimetres at the back side The autoclave should be freely accessible from above so that the built in supply tank can be filled and a good ventilation is guaranteed 15 Chapter 3 Initial commissioning 16 Space requirements Vacuklav 41 B Vacuklav 43 B A 46cm B 56cm C 69 cm D 36 cm E 21 cm F 5cm G 10 cm Table 8 Space requirements of the autoclave Additional space for feed Other than for the autoclave you will possibly require space for a water water supply treatment unit for the feed water supply Space requirements for a MELAdem 40 water treatment unit Can be directly attached to the autoclave The attachment can be next to the autoclave or above or below the autoclave MELAdem 47 Mount next to the autoclave or above or below the autoclave e g in a lower cabinet is delivered with water storage tank Table 9 Space requirements MELAdem In no case may you subject the water storage tank to sunlight This way you avoid algae formation The maximum suction height for an external water storage tank is 1 5 Notice meters Connections required m The electric connections and connections for feed water and used water may only be completed by a specialist technician Danger Non observance could lead to a short circuit and or fire and or water damage and or electrical shock Serious injuries could be the
23. value and functional reliability Maintenance intervals Ep Oil door spindle Oil the door spindle at 2 month intervals as follows Clean the spindle with a lint free cloth Apply two drops oil from the supplied oil bottle Art No 27515 in the threaded bushing page 7 Figure 1 4 in the autoclave door You will find the instructions for oiling the door spindle on the inner surface of the autoclave door Maintenance m Have maintenance carried out only by trained field service technicians or technicians of the specialist trade Turn to your specialist dealers or MELAG customer service in your vicinity m Comply with the predetermined maintenance intervals Non observance can lead to damage of the autoclave and to serious injury to health Regular maintenance is indispensable for the retention of value and the reliable practice operation of the autoclave During maintenance all functional and safety relevant components and electrical facilities must be checked and replaced if necessary The maintenance must be carried out according to the maintenance instructions relevant for this autoclave Have the maintenance regularly carried out at intervals of two years or after 2000 program cycles At this point in time the autoclave issues a maintenance reminder message National pressure vessel requirements may ask the user of pressure vessel such as autoclaves to carry out safety inspections Please check the download
24. we are dealing with third party rust If the instruments have been incorrectly prepared rust can form even on stainless steel instruments of leading manufacturers Often a single rust producing instrument already suffices for third party rust to form on the other instruments or in the autoclave Remove third party rust from the instruments with a chlorine free stainless steel cleaning agent see page 38 Cleaning or send the damaged instruments to the manufacturer for reconditioning The extent of the formation of spots on the instruments also depends on the quality of the feed water employed for steam production Use qualitatively high grade feed water Observe the following when using feed water for the steam sterilization m Use only demineralized or distilled water according to gt DIN EN 13060 Appendix C VDE 0510 In case of non observance stains can form on the instruments and the functional readiness of the autoclaves can be adversely affected You can also use distilled or demineralized water from do it yourself markets pharmacies or service stations as feed water if the VDE 0510 is explicitly noted on the label of the packaging Feed water which you can inexpensively produce by the osmosis method with MELAdem 47 or with the ion exchanger MELAdem 40 or by distillation with MELAdesf 65 satisfies the feed water requirements 39 Chapter 6 Maintenance 40 fae Danger For retention of
25. 8 17 59 06 81 Current version of the device firmware 82 Para V2 430 26 11 2008 82 Current version of the device parameter 83 BO V2 431 11 12 08 83 Current version of the user interface Step Time t m s P mbar T C SP S 0 01 0 01 989 99 6 Time Time minutes seconds elapsed since the start of the program t Duration minutes seconds of a program step SK12 1 08 0 23 295 109 0 m s SK21 1 14 0 06 646 109 9 SK22 1 37 0 23 293 112 8 P Pressure in the chamber in millibar ISK2 1 43 0 06 632 112 5 mbar SK22 2 06 0 23 293 115 6 SF12 2 23 0 17 500 112 3 T C Temperature in the chamber in degrees centigrade SF13 2 54 0 31 627 113 2 SF21 3 03 0 09 291 114 1 At the beginning of the individual lines are initials which SF22 3 45 0 42 180 99 8 indicate the type of the respective program step You will ae eo ee ated a T receive a listing of all step initials when you output a legend Ee ween NOGAT Saat ath log report with the DOCU Menu SF33 5 56 0 32 933 117 3 SHOL 6 32 0 36 2709 129 6 SHO2 6 53 0 2 2844 131 5 Program steps SSO Ls 27 0 34 3084 34 1 SK Conditioning SS02 10 57 3 30 3178 135 2 F SA00 11 26 0 29 1295 109 5 oF sFractonation STO1 13 47 2 2 94 45 0 SH Hod STO2 13 52 0 05 351 46 3 SS Sterilisation ST03 16 12 2 20 83 59 8 SA Pressure discharge SB10 16 28 0 16 800 67 1 ST Drying SB20 16 48 0 20 986 Teo SB Ventilation ISP E 16 48 0 00 986 1365 SP E End 0 00 0 0 0 0 0 0 0 0 0 0 Sensor measured values
26. Meaning Explanation Double jacket steam Glossary entry Words or phrases marked with an arrow are explained generator in the glossary The glossary is listed alphabetically It can be found at the end of this manual Universal program Software Words or phrases appearing on the display of the citation autoclave are marked as software citations Chapter 6 Logging Cross reference Reference to another text section within this User Manual Figure 1 5 Cross reference Reference to a detail in a figure in the example to Part No 5 in Figure 1 Table 2 Meaning of the emphasized text within this User Manual MELAG Danger Instruction Mains cable and power plug Double jacket steam generator Setting up installation commissioning Preparation and sterilization of textiles and instruments Program termination Removal of the items to be sterilized Maintenance Carrying the autoclave Errors Safety instructions To operate the autoclave pay attention to the following safety instructions given below and in the individual chapters of this User Manual m Do not sterilize any liquids with this autoclave Never damage or change the mains cable or power plug m Never operate the autoclave if the mains cable or power plug are damaged m Never pull on the mains cable to take it out of the socket Always take hold of the power plug itself m The autoclave remains under pressure after being switc
27. Menu and the computer is activated the log files still not transferred to the PC as the output medium but was previously not connected or switched on See event 135 FV1 Direct connection to waste water drain Kinked effluent tube FW41 wo N N Check the effluent tube for kinks or pinching 49 Chapter 9 Errors Event 428 439 433 434 435 Autoclave is overloaded observe the maximum loads use insert frame Please ensure sufficient air feed to the autoclave rear panel check for packaging residue in the chamber Surrounding temperature is too high Autoclave is installed and is receiving no or insufficient cooling air The autoclave was operated without an insert frame with the result that e g the packages of textiles has come into direct contact with the chamber and absorbed a large amount of condensate This condensate vaporized upon evacuation and forms a large amount of steam FG1 FK1 Direct connection to waste water drain Check the effluent tube for kinks or pinching Check for packaging residue in the Poor installation multiple devices attached chamber to a single siphon sagging effluent tube Kinked effluent tube Pressure release clips blocked by packaging residue FS8T Maximum permissible difference between Upon repeated occurrence inform your the theoretical temperature and that specialist dealer measured by temperature sensor 2 AINO2 Display
28. ain menu is displayed As shown in the above described example you can select the output medium in Output of stored logs Among others there is the option of selecting media selected for automatic logging as output media If you are not certain whether and which media are activated in the SETUP Menu in Automatic logging press the display Output of stored logs in INFO or briefly simultaneously press the keys 2 and 3 thereby activating the status display Under Position 06 you will find which media are activated for automatic logging in the SETUP Menu see page 11 Hot keys Diverse log output options are offered in the selection list of the Docu menu see example above A few examples are shown below Menu item in the DOCU Menu Logging list for sorting hold the appropriate key Sal Keyl Key Key3 Key4 i Batch DateTime Program Result 769 488 1227 18 06 06 09 56 Universal program OK 1226 17 06 06 11 22 Quick program B OK 1225 16 06 06 15 13 Universal program 113 1224 16 06 06 13 20 Quick program B OK 1229 15 06 06 09 12 Gentle program OK 1227 14 06 06 14 13 Quick program B OK 1221 13 06 06 16 32 Vacuum test 54 1220 13 06 06 08 14 Bowie amp Dicktest OK OUTPUT Last log Daily log files Log files of the week All program logs Error logs for the day Explanation All program logs existing in memory are shown on the display You can ort the list by holding down one of the keys 1 to 4 se
29. ams on the following output media and to archive them accordingly MELAflash CF card Computer over the network Log printer MELAprint 42 You can arbitrarily combine the output media It is thereby possible for instance to store logs on the MELAflash CF card and additionally to permit printing The logs are outputted on several activated media in sequence You select the desired output media by activating automatic logging in the SETUP menu or in the Docu menu for the subsequent log output For more on the SETUP Menu and DOCU Menu see page 13 Overview of menus and symbols In the state at initial delivery of the autoclave the MELAflash gt CF card is defined in the SETUP Menu as the output medium for text and graphic logs and automatic logging thereby the activated The automatic logging is set so that immediately after a program has finished the associated log is issued onto the activated storage medium Immediate output YES If you retain this state then when the autoclave is commissioned for the first time as soon as a program finishes the associated log is outputted to the CF card and stored there Prerequisite is that the CF card is plugged in the card slot of the autoclave After a program has finished you can immediately look at the header of the accompanying log on the display see page 34 Determine format for program log files To do this press on DOCU before opening the door In order to then output
30. ance can result in data loss damage to the card and or the autoclave and or its software The card can become unusable The card slot for the CF card is located behind a protective cover to the right next to the control panel page 7 Figure 1 1 Proceed as follows to insert the CF card in the card slot 29 Chapter 5 Logging 30 Push the protective cover as far as possible to the right until the card slot is freely accessible Card slot for CF card Protective cover Figure 7 Protective cover for card slot to the right Use the CF card with the palpable grip edge facing left in the card slot The palpable grip edge of the CF card must be facing left Figure 8 Figure 8 Insert the CF card Insert the CF card until it engages in the card slot If the CF card is correctly placed the red LED to the lower right next to the card slot briefly lights up The LED lights up briefly after the CF card is inserted in the card slot Figure 9 Insert the CF card into the card slot Push the protective cover back into the initial position and thus close the card slot The protective cover for the card slot is back in its initial position Figure 10 Closed card slot Remove CF card Proceed as follows in order to remove the CF card from the card slot Push the protective cover which is in the right upper corner next to the display of the autoclave to the right until the card slot is f
31. area from our website and find our recommendation in accordance with German requirements Fore more information ask your local authorities MELAG Chapter 7 Operating pauses In this chapter you learn How quickly you can start sterilization programs in sequence What you must observe for short breaks and longer operating pauses How to put the autoclave out of operation transport it and re commission it No pause times required Short pauses between sterilizations Pauses which last longer than one hour Energy saving o 2 16 Sterilization frequency Pause times between individual programs are not required since the sterilization chamber is permanently held at the required temperature After the expiration or termination of the drying time and removal of the items to be sterilized you can immediately re load the autoclave and start a program Pause times 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 four minutes in order for the double jacket steam generator to heat up again and be ready for operation If the autoclave is not be sw
32. arning Formation of spots due to improperly cleaned instruments Formation of spots due to third party rust Formation of spots due to inadequate quality of the feed water Attention Water in accordance with VDE 0510 arias perceptibly engages Drain off the water into a container with at least 5 litres holding capacity To remove the drain hose again press the grey release knob at the quick fitting connection The hose detaches itself automatically from the connection Please observe the following when removing the quick fitting connection m When draining the storage chambers stand to the side of the connection Be sure to hold the hose tight with the other hand while pressing on the grey release button of the quick fitting connection in order to arrest the spring tension of the connection Non observance can lead to injuries Avoid formation of spots Only if you correctly clean the instruments before sterilization can you avoid the detachment of residues resulting from loading or instrument preparation under steam pressure during the sterilization Detached dirt residues can clog the filter nozzles and valves of the autoclave and form as stains and deposits on the instruments and in the chamber see page 18 Prepare items to be sterilized All steam conducting parts of the autoclave are made of non rusting materials This excludes the formation of rust caused by the autoclave Should rust stains occur then
33. ble 1 is plugged into the power supply socket of the network adapter 3 After you have thus connected the MELAprint 42 to the autoclave switch the autoclave off and on again in order to store the IP address of the autoclave in the network adapter Using the PC as output medium You can connect a computer to the autoclave directly or over a network Prerequisite is that the PC has a network card with RJ45 socket and the autoclave is equipped with software as of Version 2 0 Moreover for protocol issue via FTP you need an FTP server communications program on your PC or an FTP service Log output via TCP requires an additional suitable program e g MELAview V2 0 Setting date and time Date and time of the autoclave must be correctly set for proper batch documentation Observe the time re settings in autumn and spring daylight saving time since this is not reset automatically Once set the clock of the autoclave is very precise Set date and time as described below n the main menu go to the symbol for the SPECIAL Menu with the navigation keys Press SELECT The SETUP Menu is opened With the navigation keys go to the menu item date or time Press EDIT With the navigation keys go to the parameter which you want to modify Day month year or hour minute second Modify the respective parameter value with the navigation keys Confirm the modification with OK Repeat the last three steps
34. cessary These contain operating procedures for you Warning messages are not error messages They help to ensure smooth operation and to recognize undesirable conditions Observe these warning messages promptly in order to avoid errors Error messages Fault 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 The program is aborted if an error occurs during a program run m fa program is aborted before the drying cycle is complete then the load is unsterile Possibly rewrap and repeat the sterilization for the affected sterilizing materials Nichtbeachtung gefahrdet die Gesundheit Ihrer Patienten und des Praxisteams Non observance endangers the health of your patient and the practice team Chapter 9 Errors MELAG Before you call Follow the operating procedures which are shown in connection with a cautionary warning or an error message on the display of the autoclave You will find the most important events in the following table Possible causes and appropriate operating instructions are listed for the events If you do not find the event in the table below or your efforts do not lead to success turn to your specialist dealer or the authorised MELAG customer service centre in your vicinity In order for us to help you keep the serial number of your autoclave and a detaile
35. consequence Electrical connection Provide the following electrical connections for the autoclave Electric circuit with 230 V and 50 Hz 16 A separate fuse protection at least Automat Type B Protection from leakage current 30 mA Connected load 3400 VA Chapter 3 Initial commissioning MELAG OF sees Wastewater drain Cae CEFF is In order to prevent water damage MELAG recommends the use of a leak monitor e g a water stop valve from MELAG You can discharge the autoclave alternatively with the connection pressure release see page 7 Figure 1 22 or over the one way drain see page 7 Figure 1 20 directly to the drain The drain must be located below the autoclave Connection pressure discharge Rotate the pipe fitting on the device and replace the copper gasket MELAG Art No 32050 You can order the required parts with the MELAG Art No 39181 One way drain hose as wastewater connection You can a order two meter long hose MELAG Art No 36582 for this purpose The waste water hose must be able to be laid with a continuous dip free descent For wastewater paths which are longer than two meters MELAG recommends a fixed laying of HT high temperature pipe carried out by a specialized installation firm Prerequisites for initial commissioning The following prerequisites must be satisfied for initial commissioning The feed water supply must be secured For the first filling of the
36. d If possible do not rename the directories The autoclave would create a new directory because it would no longer recognize the existing one There would be logs in the renamed directory as well as in the directory created once again by the autoclave If there is a multiple output of logs on the same output medium a subdirectory named Double is created in the device directory The longs are only stored once in this directory 37 MELAG 38 Chapter 6 Maintenance In this chapter you learn How to clean the autoclave and which cleaning agents are suitable How to avoid the formation of spots Which feed water to use How to oil the door spindle What you must observe for the autoclave maintenance Weekly inspection of chamber door seal mounting chamber sealing surface In case of contaminations Attention Housing parts Internal water storage tank for feed water Empty internal storage tank Cleaning Examine the chamber including the door seal and chamber sealing surface and the mounting for loading page 8 Figure 1 for contaminants deposits or damage once a week If you determine any contaminations draw the existing trays or cassettes and the associated mounting forwards out of the chamber Clean the contaminated parts When cleaning the chamber the loading mounting the chamber sealing surface and the door seal observe the following m Switch the autoclave off before cleaning an
37. d by the feed procedure feed pump runs The feed water is preheated for generating steam DOOR CONTINUE Preparation time After the autoclave was switched on at the mains switch page 7 Figure 1 7 it requires a heating up period for the initial preheating of the double jacket steam generator For normal operation this time is Vacuklav 41 B 9 minutes Vacuklav 43 B 13 minutes 7 The main menu appears on the display As soon as the device is I oe E K aia switched on the default program selection is Universal Program Universal Program TEE 134 C 2 1 bar 05 30 min P instruments textiles wrapped and unwrapped oo gt ER Fal R ia 5 io OPEN START Chapter 2 Device Description 10 ll 4241 2008 11 22am epee Universal Program oleje 134 C 2 1 bar 05 30 min it qF instruments textiles wrapped and unwrapped GR Key1 Key2 Key3 Key4 Figure 6 Control panel Key settings Hot keys Control panel The control panel consists of a display and four membrane keys The display can show 320 x 240 pixels 1 Key 1 serves primarily for navigation 2 Key 2 serves primarily for navigation 3 4 Key 4 serves primarily for selecting options Key 3 serves
38. d fault description in readiness Event Key Possible causes What you can do 54 SUUS Operator has terminated the program with Acknowledge termination by simultaneous the STOP key pressing the keys CONFIRM and DOOR OPEN 61 FW11 For external supply tank for feed water _ Fill external supply tank No water in the tank Check intake hose and Intake hose bent clean suction filter Suction filter clogged or not in the water or For water treatment unit Produces no water because the water tap open water inlet for the water treatment unit is not open 63 WW12 For external supply tank for feed water Empty and clean supply tank see page 38 64 FW12 Water with inadequate water quality was Empty internal storage tank and fill with 65 WW13 poured into the supply tank gt 60uS cm feed water of the quality VDE 0510 or For water treatment unit Mixed bed resin pellets in the water renew mixed bed resin pellets for the water treatment unit are exhausted treatment unit 67 WW22 Water outlet not guaranteed Check waste water hose let water drain 68 FW 22 out check siphon 72 The feed water quality is declining gt 40 You can still carry out all work with the 73 uS cm autoclave but should fill up with new feed 74 Mixed bed resin pellets soon exhausted water as soon as possible or renew the 75 mixed bed resin pellets 76 WW21 See event 67 78 FW31 Waste water tank was not or only Empty waste water tank completely 79 WW33 incompletely empti
39. d pull the power plug from the wall socket Make sure that the chamber is not hot Employ a soft and lint free cloth Use chlorine and vinegar free cleaning agents First drench the cloth with cleaning alcohol or methylated alcohol and attempt to wipe off the contamination m For persistent soiling of the chamber mounting or chamber sealing surface employ only a mild stainless steel cleaning agent with a pH value between 5 and 8 Employ neutral liquid cleaning agents for cleaning the door seal No cleaning agents may get into the piping system which exits the autoclave chamber m Do not use any rough objects such as pot cleaners made of metal or steel brushes In case of non observance the cleaned surface could become scratched or damaged and the sealing surfaces untight This would promote dirt deposits and corrosion in the sterilization chamber Clean the housing parts with neutral liquid cleaners or methylated alcohol If you provide the feed water supply manually via the internal storage tank check for soiling when you refill the feed water if necessary clean the tank with a cloth and fresh feed water before refilling Clean the left side of the water storage tank waste water every two weeks The both chambers are emptied as follows Attach the drain hose on a quick fitting connection left of the wastewater tank to the right of the feed water tank until this Chapter 6 Maintenance MELAG W
40. drums 23R 2 Steriliz containers 28M max 2 Sterilization containers 28M 1 Steriliz containers 28G max 1 Sterilization containers 28G 3 standard tray cassettes 3 standard tray cassettes Textiles Maximum measurements for each component Maximum total weight Tray mounts trays sterilization containers standard tray cassettes from MELAG see Appendix A Accessories Table 10 Loading variants example of mounting C and maximum load 21 Chapter 4 Sterilization Select program Select the desired program with the navigation keys in the main menu Select the sterilization program accordingly depending on how the sterilizing materials are wrapped Furthermore consider the resistance to high temperature of the items to be sterilized me 1211 2008 11 22am ide Universal Program EE e e tae de All sterilization programs are displayed in the main menu wrapped and unwrapped EF gt A The following table shows which program to use for which items to be 2 Aa sterilized 5 io OPEN START Wrapping Especially Sterilization Operation Drying Load suitable for for time 41 B 43 B Ep single and mixed loads Universal A multiple long narrow bore jprogram D wrapping hollow bodies 134 C about 21 min 15 min 6kg 7kg Instruments where a danger of infec
41. e page 11 Hot keys Select individual logs by briefly pressing the navigation keys These ill be outputted via OUTPUT to the previously selected storage medium The log report of the last completed program is outputted to the previously selected medium The logs of the current day are outputted to the previously selected medium The logs of the week Monday to Sunday are outputted to the previously selected medium All program logs existing in memory are outputted to the previously selected medium The fault logs of the current day are outputted to the previously selected medium Table 12 Examples of log output options Connect printer Use log printer as output medium If you want to employ the printer MELAprint 42 as the output medium connect it as follows to the autoclave 33 Chapter 5 Logging 34 Figure 12 Printer connection top view Observe time re settings jo 216 Plug the power supply 1 into the wall socket Connect the MELAG network adapter 3 with the supplied cable 2 to an Ethernet data connection point of the autoclave see page 7 Figure 1 13 Plug the gt MELAG network adapter 3 into the serial connection of the printer MELAprint 42 can be screwed Plug cable 4 of the adapter 3 into the power supply socket of the printer Switch on autoclave and wait for the main menu start up The printer is switched on when the power supply ca
42. e sterilized load with unwanted or harmful materials Corrosion Chemical change or destruction of metallic materials by water and chemicals Delayed boiling This is the phenomenon that in certain conditions liquids can be heated beyond their boiling point without boiling this state is unstable a slight shock can cause a very rapid formation of a large gas bubble which expands like an explosion Demineralized water Water without the minerals which occur in normal mineral or tap water obtained from normal tap water by ion exchange here used as feed water DGSV Deutsche Gesellschaft f r Sterilgutverordnung German Association for Sterile Material Directive the training guidelines of the DGSV are listed in DIN 58946 Part 6 as Personnel Requirements DIN 58953 European standard sterilization sterile goods supply DIN EN 285 European standard sterilization steam sterilizers large sterilizers DIN EN 867 5 European standard non biological systems for use in sterilizers Part 5 Stipulations of indicator systems and testing bodies for performance tests of small sterilizers of Type B and Type S DIN EN 868 European standard Packaging materials and systems for medical devices to be sterilized DIN EN 13060 European standard Small steam sterilizers DIN EN ISO 11140 1 European standard Sterilization of products for health care chemical indicators Part 1 General requirements Display Disp
43. ed 80 WW32 102 FA8 Waste water hose is bent or installed with a Check waste water hose It must be laid large droop dip free with continuous descent 47 Chapter 9 Errors 48 Event 113 116 117 118 119 123 124 125 126 128 129 134 135 136 183 175 176 Key FUN1 Autoclave was switched off while a program was running Power connection not completely made Power plug was withdrawn Power loss in the building power supply FS1T Maximum permissible difference between the theoretical temperature and that measured by temperature sensor 1 AINO1 is too large FS2T Temperature sensor 1 or 2 is defective temperature difference is too large FS3T Maximum admissible sterilization temperature has been exceeded at temperature sensor 1 AINO1 FS4T Minimum admissible sterilization temperature not reached at temperature sensor 1 AINO1 FT1 Ambient temperature too high FV5 Built in autoclave gets no or too little FVO cooling air FV8 Autoclave is overloaded Autoclave was operated without mounting so that for instance a washing packet has direct contact with the chamber and large quantities of condensate were absorbed Was WE3 Autoclave overloaded Defective power supply under dimensioned house connection for the outlet defective outlet numerous devices to one outlet or fuse WV3 FW40 Cooling water inlet not opened Coolant hose bent Shut off cock in the cellar is tu
44. em 47 The items to be sterilized are dried by the vacuum vacuum drying This way you achieve optimal drying results for wrapped objects as well The autoclave works with an electronic parameter control This way the autoclave optimizes the total operating time of a program depending on the load The autoclave checks the pressure and temperature in the sterilization chamber at all times and does not permit the door to be opened in case of overpressure in the chamber The motor operated automatic door lock opens the door by slowly turning the locking spindle and holds the door while it opens Pressure compensation takes place even if there is any difference in pressure until the door is completely opened The quantity and quality of the feed water is checked A process evaluation system is integrated in the electronics of the autoclave During a program it compares such process parameters as temperatures times and pressures with each other It monitors the parameters with respect to their limit values at activation and control and guarantees a safe and successful sterilization A monitoring system checks the device components of the autoclave with respect to their functional reliability and their plausible interaction If one or more parameters exceed defined limits the autoclave issues warnings or error messages and if necessary aborts the program In the event of an automatic program abort observe the information on t
45. end and leave the door ajar The door seal is thus relieved and protected from premature fatigue Furthermore it prevents the sticking of the door seal Turn the cooling water inlet off and if available also the water feed of the water treatment unit Operating pauses which last After operating pauses which last longer than two weeks conduct a longer than two weeks vacuum test and thereafter an empty sterilization with the Quick Program S see page 44 Chapter 8 Function test The following situations can occur after longer pauses Event Possible cause What you can do conductivity too high Bad feed water Change the feed water or the mixed bed resin pellets for a MELAdem unit Despite running motor Door seal is sticking to the Switch the autoclave off and pull vigorously at the door to the door does not open sealing surface open it Table 13 Possible situations after operating pauses which last longer than two weeks Function test after pauses After pauses and depending on the pause duration conduct tests described in Chapter 8 Function test Decommissioning If you would like to decommission the autoclave put it out of operation for a longer period of time for instance because of holidays or a planned transport proceed as follows Switch the autoclave off at the mains switch Pull the power plug from the wall socket Turn off the cooling water inlet and if applicable also the water feed of
46. f steam into the sterilizer load and that the air leakage is not a possible cause of a renewed contamination of the sterilizer load during drying aqua dem demineralized water aqua dest distilled water Authorised persons Technicians from depots or employees from service companies designated by MELAG that are trained by MELAG Batch Collection of the items to be sterilized that together passed through one and the same sterilization program BGV A1 Trade association regulations Principles of Prevention Bowie amp Dick Test Steam penetration test with standard testing packet described in DIN EN 285 test is recognised for large scale sterilizations CF card Compact Flash Card Memory card for digital data of compact model size CF is anormed standard i e this memory card can be employed in every device with a CF slot The CF Card can be read and possibly written by every device that supports the standard Condensate A liquid e g water which forms upon cooling from the vaporous state and thereby separates Conductivity is the reciprocal value of the electrical resistance unit of measurement in microsiemens centimetre US Cm the more materials are dissolved in water the better it conducts electrical current and the higher is its conductivity distilled water ideally has the conductivity zero Conductivity measurement Measurement of the conductivity Contamination here Soiling of th
47. f the program the pre selected start time is deleted 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 Start program If you have selected a program with the navigation keys it is displayed marked inversely highlighted You can now activate it by pressing the START key The door locks pressure proof as soon as the program starts The autoclave checks the quantity of the feed water and its conductivity At the start of the quick program S a cautionary note appears coupled with an acoustic signal Unwrapped instruments may exclusively be sterilized with the quick program S If the load exclusively contains unwrapped instruments confirm with YES to start the program Program is running A program runs in three phases After starting a program you can track the program sequence on the display Chamber temperature and pressure as well as the duration until sterilization or end of drying are displayed 23 Chapter 4 Sterilization 06 20 2006 SF23 2nd Fractioning steam 11 21am intake Universal program running 117 26 Chamber temperature 85 7 C Chamber pressure 0 58 bar 15 min min until drying end aac DETAILS STOP Follow the programme run on the computer Evacuation phase Sterilization phase Dry
48. for all parameters which you want to modify Press CONFIRM to return to the SETUP Menu Go with the navigation keys to Exit MENU and SAVE Press OK in order to save the settings permanently Determine format for program log files One log report is stored in the internal log memory for every completed program You determine with the logging format which of the stored data should be outputted You can choose between a short form 0000 a medium sized form 0001 and a long form 0002 Chapter 5 Logging MELAG Standard format 0002 The medium logging format 0002 is the standard format You determine the print formats for the program log files in the SETUP menu under the menu item Automatic logging Logging format 10 MELAG Vacuklay 41 B 15 Programm 20 Programmtyp 25 Datum 30 Tages charge Schnel1 Progranm E 434 C 1x verpackt 20 01 2009 01 Gesamt 00300 nell Programm E erfolgreich beendet Temperatur Druck Plateauzeit Leitwert Startzeit Endezeit 235 2 0 13 0 27 C 2 17 0 01 0 02 bar min 30 5 ws fom 175 0 0 159107 1 16 15 17 08 min 80 S5SN 200741 B1224 81 FW W2 431 Now 28 2008 17 59 06 430 26 11 2008 431 11 12 08 5 P mbar TL 01 284 59 1615 7a ooononowpooooonoonoooooooooonoon in folgender Zeile nie ndern lt lt A0000005 006301894FT903070404043131A43488 achweis Chargenprotokoll lt lt a R E a E E certs ENDJ kondi ti nierung Kondi tion
49. ghly for instance with the help of a thermal disinfector m After disinfection and cleaning rinse the instruments with demineralized or distilled water and subsequently thoroughly dry the instruments with a clean non fuzzing cloth m Employ only cleaning materials which are suitable for steam sterilization Ask the manufacturer about the cleaning materials In case of non observance residual dirt can possibly be loosened up during sterilization in the steam pressure Rests of the disinfection and cleaning agents lead to corrosion Increased maintenance requirements and the impairment of the function of the autoclaves can be the consequence Unsuitable cleaning materials e g water rejecting cleaning materials or steam impermeable oils can result in unsterile instruments This endangers your health and the health of your patients When using the following devices observe without fail the preparation instructions of the instrument manufacturer To disinfect and clean the instruments MELAG recommends the use of auxiliary materials such as Ultrasonic units Maintenance appliances for hand and angle pieces Cleaning and disinfection devices 19 Chapter 4 Sterilization 20 Kg e Wrapping Attention Closed sterilization containers i Attention Stack sterilization containers Attention Soft sterilization wrapping Attention Load the autoclave Only if the autoclave is properly loaded can
50. hamber alternating with steam intake Heating up period After switching on the autoclave or after starting a sterilization program it is the time required for heating up of the double jacket steam generator before the sterilization process starts duration depends on the temperature of the sterilizing process Hollow A One sided open bodies for which applies 1 lt L D lt 750 and L lt 1500 mm or a double sided open body for which applies 2 lt L D lt 1500 and L lt 3000 mm and which does not correspond to the hollow body B L hollow body length D hollow body diameter DIN EN 13060 Hollow B One sided open bodies for which applies 1 lt L D lt 5andLs5mmor a double sided open body for which applies 2 lt L D lt 10andD25 L hollow body length D hollow body diameter DIN EN 13060 Hot Key Quick Key key or combination of several keys which was assigned to a certain function Initialization Creation of a certain initial state of the software at start up Items to be sterilized Unsterile objects materials still to be sterilized LED Abbreviation for Light Emitting Diode Semiconductor diode which lights up when powered by current LEDs are predominantly employed for status displays in devices for example to display hard disk access Lubricants Instrument oil or instrument milk MELAG Ethernet adapter Ethernet printer module for the MELAG printer MELAprint 42 the printer connect
51. he display You can conduct an additional function check at any time with the help of test programs Use the vacuum test to check the autoclave for leaks in the steam system Use the Bowie amp Dick test to check whether there is sufficient steam penetration for porous material to be sterilized e g textiles The autoclave has an internal log memory All data of the completed sterilization programs are automatically stored here You can read out the internal log memory immediately after the end of the program or at a later time You determine whether the logged data are issued to one or several different output media e g log printer MELAprinf 42 MELAflash CF card computer Chapter 1 Performance Specification MELAG Overview of sterilization programs Universal Quick Quick Gentle Prion Type tests Program Program B Program S Program Program Program type as per Type B Type B Type S Type B Type B DIN EN 13060 Dynamic pressure test of the sterilization chamber Air leak Empty chamber test Solid load Porous partial load Porous full load Hollow body B Hollow body A Simple wrapping Multiple wrapping x X X X XxX XxX x Xx Xx e Drying solid load Sterilization temperature 134 C Sterilization pressure 2 bar Sterilization time 20 5 minutes X Conformity with all applicable sections of the standard DIN EN 13060 Table 3 Overview of s
52. hed off Check the pressure display of the manometer located on the autoclave lower front side m Only have the autoclave set up installed and commissioned by people authorized by MELAG m Only operate the autoclave in areas which are not subject to explosion hazards m The electric connections and connections for feed water and used water may only be completed by a specialist technician m Follow the instructions of the textile and instrument manufacturers for preparing and sterilizing textiles and instruments m Observe the relevant standards and directives for the preparation and sterilization of textiles and instruments e g gt RKI Robert Koch Institute and DGSV German Society for Sterile Supply m Only use wrapping materials and systems which are suitable for steam sterilization according to the manufacturer s information m 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 m 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 open the door by force 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 m Check the wrapping of the sterilized
53. hout hollows or spaces firm dense closed Solid load check of solid load Serves to verify that for the values set on the control the required sterilization conditions were achieved within the entire load The load must represent the maximum measurements of solid instruments for whose sterilization a sterilizer has been designed according to DIN EN 13060 DIN EN 13060 Standards compliant Conformity with all the relevant standards Stainless steel cleaning agent e g Sidol Sterilization chamber Interior of a sterilizer Takes up the items to be sterilized Sterilized items also designated as batch if already successfully sterilized sterile goods TCP engl transmission control protocol designates a standard protocol for a connection between computers and networks Vacuum colloquially Space free of matter in the technical sense Volume with reduced gas pressure usually air pressure Vacuum drying Gentle drying the drying goods are exposed to an underpressure which reduces the boiling point and thereby also at low temperatures leads to a vaporizing of the water VDE Verband der Elektrotechnik Elektronik und Informationstechnik e V Association of German Electricians VDE 0510 Standard of the VDE Provisions for accumulators and battery units Warming up time heating up period Water ring pump Pump which creates the vacuum for the sterilization cooled with water 53 MELAG Append
54. i erung Kondi tioni erung Kondi tioni erung Kondi tioni erung Kondi tioni erung Kondi tioni erung Champfeinl ass COruckabl ass CDampfeinl ass COruckabl ass Dama fein ass COruckabl ass COampfeinlass Component Header Values for the program steps Logging format pooo oo Konditionierung Typ COruckablass Fraktionierung Evakuieren Fraktionierung Dampfeinlass Fraktionierung Oruckablass Fraktionierung Evakuieren Fraktionierung Dampfeinlass sFraktionierung Oruckablass Fraktionierung Evakuieren Fraktionierung Dampfeinlass Halten Oampfeinlass Halten Regeln Sterilisation Eintritt sterilisation Druckablass Trocknen 1 Vakuum Trocknung Trocknen Bel ftungs Trocknung Trocknen 2 Vakuum Trocknung Bel ften 1 Bel ften 2 Ende Standard format Table 14 Logging format and their components Header Values of the program steps Legend Reading log files correctly The header is outputted for all three selectable log report formats The format 0000 contains only the header of a log record The header of the program log record comprises the lines 10 to 80 and contains the most important information for the completed program such as whether the program was successfully concluded and the authenticity proof Among other data the time pressure and the temperature are recorded during the program If you select the program format 0001 or 0002 then these values are outputted The
55. ickly after one another once you ve gained a certain routine with the autoclave The autoclave has an input buffer This buffer registers which key was pressed in what sequence and implements the corresponding functions Diverse messages are issued in the right upper corner of the display Several examples are shown below Messages are marked by an envelope icon Such information supports you in the operation of the autoclave Messages are not error messages or warning messages Warning messages help you to ensure a smooth operation and to recognize undesirable conditions Warning messages are not error messages 11 Chapter 2 Device Description 12 Error messages Reverse selected display ly i g g Signal 1 x 0 1 seconds 1 x 0 5 seconds 2 x 0 5 seconds 3 x 0 5 seconds 5 x 0 5 seconds 8 x 0 5 seconds 10 x 0 5 seconds Table 6 Overview of acoustical signals Error messages indicate an error or a malfunction You can only start programs or change settings if these are marked as selected indicated by reverse display highlighted Example not marked normal display marked reverse display Acoustical signals The autoclave emits acoustical signals The signals are meant to catch your attention and serve as sources of information The time interval between two signals is 0 5 seconds Confirms the correct pressing of a key Warning or communication Door is open sounds every 30 second
56. igure 5 Mounting D Chapter 2 Device Description MELAG Switch on autoclave Observe the following precautionary measures when handling the mains cable and power plug Danger m Never splice or modify the mains cable Never bend or twist the mains cable m Never pull on the mains cable to take it out of the socket Always take hold of the power plug itself m Never place any heavy objects on the mains cable Never run the mains cable over places where it could be squeezed e g doors or windows Do not run the mains cable along a heat source Do not use any nails staples or similar objects to fixate a cable If the mains cable or the power plug is damaged turn off the autoclave Mains cables or power plugs may only be replaced by authorized persons If these points are not observed the cable or plug can be damaged and or a fire or electrical shock might occur Serious injuries could be the consequence Plug power plug into the If the autoclave is still not connected to the supply mains plug the power socket plug into the socket Switch on mains Turn the mains switch on to power the autoclave page 7 Figure 1 7 After switching on On the display you see the start screen Welcome The software of the 200 208 autoclave is initialized and its device components are checked Welcome The level of the feed water in the double jacket steam generator is automatically checked and if necessary maintaine
57. ing of items to be sterilized for a load as described in this Chapter see page 20 Load the autoclave For difficult drying tasks you can extend the drying time of a program by 50 with the function Additional Drying To do this before starting a program hold key 1 pressed down until the symbol for additional drying appears above the key on the display Additional drying is always active at program start If you have inadvertently activated the additional drying feature press a navigation key in order to deactivate it again The function start time pre selection enables you to select any program and start it at a time of your choice In order to do so after selecting a program hold the START key depressed until the display changes to the start time pre selection display Press the EDIT key to change the pre set time date The field Time and Date are highlighted You can change the time by pressing the and keys The date can only be changed in conjunction with the clock by crossing the 24 0 hours border Then press the OK key The display remains in the display screen pre selection start time and does not return to the main menu After setting the program start time no further changes or settings to the autoclave can be undertaken as the start time pre selection would otherwise be deleted The start time pre selection is only active for the unique time and program selection That means that after completion o
58. ing phase 06 20 2006 STO1 Drying 1st vacuum drying 11 36am 417 303 Universal program running Drying immediate removal with STOP Chamber temperature 57 9 C Chamber pressure 0 81 bar 14 min Frogram successful until drying end DETAILS STOP 24 By pressing the DETAILS button you can have additional information on the ongoing program provided on the display By repeated long pressing of the DETAILS button this information is once again hidden You can follow the current progress of a current sterilization programme in a web browser on every computer of the user network via the website integrated in the autoclave The autoclave must be assigned an IP address and is connected to the user network Open a web browser window we recommend Mozilla Firefox or Internet Explorer Enter the autoclave IP address on the user P C in the address bar of the web browser e g 192 168 57 41 and confirm with enter Now you can display the program run or information about your autoclave e g serial number software version and selected values MELAG Premium Autoklav Web Server Mozilla Firefox Loe Datei Bearbeiten Ansicht Chronik Lesezeichen Extras Hilfe 3 Q w G Q A Mhttp 1921685741 O Qr Google Links anpassen odge W rterbuch MELAG Medizintech METIS Login gt gt Program course t Mu e English 28 01 2009 14 13a
59. ion is located on one side the socket connector for a network cable on the other Mixed load Wrapped and unwrapped materials to be sterilized within one load Multiple wrapping e g instruments doubly sealed in foil or wrapped in foil are additionally found in one container or in a textile wrapped container Porous Pervious to liquids and air e g textiles Porous small parts Made of materials which can absorb fluids e g liquids Porous partial load Check of porous partial load Serves to verify that for the values set on the control the steam quickly and uniformly penetrates into the defined test packet DIN EN 13060 Porous full load Check of porous full load Serves to verify that for the values set on the control the required sterilization conditions are achieved in porous loads with the maximum density for their sterilization in a sterilizer designed according to gt DIN EN 13060 DIN EN 13060 Process evaluation system Also self monitoring system observes itself acts during the programs compares sensors with each other RKI Robert Koch Institute Se f monitoring system process evaluation system Simple wrapping Wrapped once e g instruments sealed in a foil contrasted to Multiple wrapping Soft sterilization package e g paper bags or clear plastic sterilization packages Software non material components of a EDP system e g computer programs Glossary MELAG Solid Wit
60. is too large FSST Maximum admissible sterilization Upon repeated occurrence inform your temperature has been exceeded at specialist dealer temperature sensor 2 AINO2 Display FS6T Minimum admissible sterilization Upon repeated occurrence inform your temperature not reached at temperature specialist dealer sensor 2 AINO2 Display Table 18 Important warning messages and error messages 50 Bad drying results Apart from a proper device function the drying process depends decisively on the correct setting up and loading of the autoclave What you can do Check the correct set up of the autoclave If necessary increase the tilt by unscrewing the front feet of the unit by max two revolutions The floor of the vessel must be free Where applicable remove fallen instruments filter paper etc Pay attention to the correct loading of the autoclave see page 20 Load the autoclave Do not overload the autoclave Pay attention that textiles have no direct contact with the chamber wall and floor Employ the Additional Drying function see page 23 Additional drying Glossary MELAG Glossary Air leakage checking the air leakage Air leakage is an untight location through which unwanted air can enter or escape Checking the air leakage serves to verify that the volume of the air leak in the sterilization chamber during the vacuum stages does not exceed a value where it would prevents the intrusion o
61. itched off during longer operating pauses the energy saving mode can be set This reduces the time which the autoclave requires in order to pre heat the double jacket steam generator to the necessary start temperature Two levels can be set in energy saving mode Waiting time 1 After a preset waiting time of 15 minutes the temperature of the double jacket steam generator is reduced to 103 C The program run time becomes c 2 minutes longer upon the next start The waiting time can be changed in intervals of one minute Waiting time 2 After a preset waiting time of 60 minutes the double jacket steam generator is no longer heated Accordingly the length of the program run 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 The waiting time can be changed in intervals of 30 minutes Set the energy saving mode as follows n the main menu use the navigation keys 1 or 2 to go to the symbol for the SETUP Menu Press SELECT The SETUP Menu will open Use the navigation keys 1 or 2 to go to the menu point Energy saving mode Press EDIT 41 Chapter 7 Operating pauses 42 Modify the respective values for waiting time 1 or waiting time 2 via the navigation keys Longer operating pauses Switch the autoclave off for longer operating pauses e g overnight or on the week
62. ix A Accessories Appendix A Accessories Article Order Number Vacuklav 41 B Vacuklav 43 B Tray mounts B for 4 standard tray cassettes 40234 40224 C for 6 trays or 3 standard tray cassettes 40232 40242 D for 2 high cassettes or 4 trays 46840 Sterilization containers 15K depth width height in centimetres 18 12 4 5 00151 Peis ale ais i 5M depth widthheight in centimetres 00152 DIN EN 868 8 i 15G depth width height in centimetres 35 12 8 00153 17K depth width height in centimetres 20 14 5 00171 17M depth width height in centimetres 41 14 5 00172 17G depth width height in centimetres 14 14 9 00173 Swab drum with 17R diameter height in centimetres 13 10 5 00174 filter cloth 23M depth width height in centimetres 42 16 6 00231 23G depth width height in centimetres 42 16 12 00232 Swab drum with 23R diameter height in mm 18 14 00233 filter cloth 28M depth width height in mm 32 16 6 00284 28G depth width height in mm 32 16 12 00285 Standard tray cassettes perforated depth width height in mm 29 19 4 with filter cloth 00289 without filter cloth 00286 trays tray 00280 00230 Helix test body system MELAcontroP consisting of Helix test body and 01080 250 indicator strips Water treatment MELAdem 40 ion exchanger 01049 units MELAdem 47 reverse osmosis system 01047 For the Documentation MELA flash CF card 01043 MELA flash CF card reader 01048 MELAprint 42 log printer 01042 MELAG Ethernet adapte
63. lay device on electronic devices here Graphic display of the control panel Distilled water also Aquadest from lat aqua destillata is largely free of salts organic materials and microorganisms obtained by the distillation vaporising and subsequent condensation of normal tap water or pre cleaned water here used as feed water Double jacket steam generator Serves the rapid steam production outside of the actual sterilization chamber surrounds the sterilization chamber 51 Glossary 52 Dynamic pressure test of the sterilization chamber Serves to verify that the rate of the change of pressure occurring in the sterilization chamber during a sterilization cycle does not exceed a certain value which could lead to damage of the wrapping material DIN EN 13060 Empty chamber test Test without load carried out in order to evaluate the performance of the sterilizer without the influence of the load permits checking the maintained temperatures and pressures with respect to the intended settings DIN EN 13060 Evacuation Creation of a gt vacuum in a vessel Feed water is required for the creation of water steam for the sterilization typical values for the water quality according to DIN EN 285 or gt DIN EN 13060 Appendix C at least however battery water according to VDE 0510 Fractionated vacuum method Technical methods of steam sterilization the repeated evacuation of the sterilization c
64. mined in the SETUP Menu and output the respective logs Shortly thereafter the notification log memory full is displayed Then you have the last opportunity of archiving logs that have not yet been outputted before the data in the log memory of the autoclaves is automatically deleted except for the last 40 logs If no CF card is plugged into the card slot but was for instance already activated as the output medium in the factory settings a cautionary warning appears on the display Thus if you would like to employ the CF card as the output medium it must be inserted in the card slot if this has not yet been done If you at this time have no CF card at hand you can output the logs later with the DocU menu Due to the large memory requirements with real time graphical recording it is recommended that you use only MELAflash CF cards with a memory capacity of 1GB or more from MELAG These are despatched in a certified and formatted state It is well known that some older CF cards with 256 MB memory capacity can cause file system problems e g implausible files on the CF card Plug in and remove CF card Follow the following instructions for using a CF card Never insert the CF card forcibly into the card slot Never draw the CF card out from the card slot during write and read access During write and read access the red LED to the lower right next to the card slot briefly lights up in irregular short intervals Non observ
65. nd Berlin Brandenburg monitors the product certification 55
66. ohol disinfectant Storage duration in accordance with the type of package wrapping The maximum storage life depends on the packaging and the storage conditions For sterilized items which have been wrapped in compliance with the standards dust protected storage is assumed this time period is up to six months 27 MELAG 28 Chapter 5 Logging in this chapter you learn Why and how you document batches Which output media you can employ for the batch documentation in which way Where you can find the logs for the batch documentation How to read the logs correctly How to set the date and time at the autoclave Output media State on initial delivery Automatic log output immediately after the end of the program Log output at time selected by yourself Batch documentation The batch documentation is indispensable as documentation for the successfully completed sterilization process and as an obligatory measure of quality assurance The data such as type of program as well as batch and process parameters of all completed programs are stored in an internal log memory of the autoclave For the batch documentation you can transfer the internal log memory readout and the data onto diverse output media This can take place immediately after every completed program or subsequently e g at the end of a work day in the practice You have the possibility of storing the logs of the completed progr
67. ond PC recording interval in sec indicates the time intervals in which the program curve is recorded if the computer is selected as output medium The smaller the time interval the more exact the curve In the example the time interval is set at 1 second PC backup interval in sec indicates the time interval in which the graphic data is saved from the autoclave is saved on the computer In the example the backup interval is set at 30 seconds Graphic logs can not be saved in the internal log memory If you wish to record optional graphic protocols in addition to the text protocols please always ensure that at least one common output medium has been set for issuing text and graphic protocols This means that at least the computer or the CF card should correspond as output medium for both protocol types 31 Chapter 5 Logging 32 Example Deactivation of automatic logging with immediate output oy B op Example Output all stored logs on CF card oO oO o o og m MELAprint Device name IP addr Sal T64 SOS Output of stored log files via selected media for automatic logging You can EDIT the output media The selection of media for the automatic logging keeps unmodified adjustable in the SETUP only f automatic logging ACTIVE the output of stored log files changes also the counter and markers for the log files that already have been stored for each selected media Automa
68. or initial commissioning 17 Installation and installation report 00 17 Chapter 4 Sterilization cc cetsesseeseeneees 18 Create prerequisites 0 ee eeeeeeeeeeeeeeeenteeeeeenes 18 Prepare items to be sterilized 0 eee 18 Load the autoclave n e 20 Select program seitei ee ieie iia 22 Start program iiini ii idadi i 23 Program iS UNNIN eeeeeeeeseeeeeeeeeeeeeneeeeeeeeees 23 Sterilization phase is finished 25 Drying phase lenar eens eeeeeeaeeeceeeeeeeentnaeees 26 Program is finished 26 Display batch numbet cecseeeeeeeeeeeeteees 26 Remove sterilized items oe eee eeeeneeeeeneeees 26 Storage of sterilized items eee eeeeeeeeeees 27 Chapter 5 LOQGING ccseceseeeseeeseeeseeeeeeeeee 28 Batch documentation cc eeeeseeeeeeeeeeenneeeeeeeees 28 Plug in and remove CF card 29 Automatic immediate log output eee 31 Subsequent output of stored logs eee 32 Use log printer as output medium 33 Using the PC as output medium eeeeees 34 Setting date and time 34 Determine format for program log files 34 Reading log files Correctly eeeeeeeeeeeeeeeeees 35 PINGING OJS lt 2 ccs ci ceed eet na ee Ae ienaa ieis 37 Chapter 6 Maintenance s nseseseesnnrnnenneenne 38 Cleaning aisen iea a nA Geiss 38 Avoid formation of Spots neee 39 Use qualitatively high grade feed water
69. or message Warning message DEMO Mode Diagnosis and Service Table 7 Overview of menus and symbols 13 Chapter 2 Device Description Feed water with internal storage tank Internal supply tank Distilling unit MELAdest 65 Feed water with water treatment unit Water treatment units MELAdem 40 and MELAdem 47 Eg A Attention The door should only be opened upon Ex loading or unloading This saves energy 404 21 Please close door Fress door closed firmly for one second or secure with hand wheel Thermo labile material should be loaded shortly before program start Locked door E ue Supply with feed water The autoclave requires demineralized or distilled feed water for generating steam The feed water supply is provided either with the internal supply tank or with a water treatment unit e g MELAdem 40 MELAdem 47 The autoclave automatically sucks in the feed water If you employ the internal supply tank for the feed water supply you must fill it manually from time to time Employ only water available on the market according to VDE 0510 as feed water The internal supply tank holds maximum 5 liters This quantity of feed water suffices for up to 7 sterilizations With the MELAdesf 65 distilling unit you can produce feed water in the practice cost effectively A water treatment unit is connected to the drinking water grid It produces
70. ou keep the door closed you will save energy MELAG Chapter 3 Initial commissioning In this chapter you learn who may set up install and commission the autoclave which prerequisites you must create for setting up installing and commissioning the autoclave where you will find additional information Danger Attention Location Attention Distance to the surrounding surfaces Conditions for setting up installing and commissioning m Only have the autoclave set up installed and commissioned by people authorized by MELAG According to the currently valid VDE standards this device is not suitable for use in areas subject to explosion hazards m The autoclave is intended for use outside the patient environment The minimum distance to the treatment area must have a radius of at least 1 5 meters Damages to the autoclave and or injuries can occur in case this precaution is not observed Set up location requirements 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 m Without fail keep the specified distance free to the surrounding surfaces at the sides and above the autoclave Non observance can lead to heat accumulation This could adversely affect the function of the autoclave and entail the shorting of the service life of the vacuum pump and extended program times The distance of the autoclave to
71. primarily for selecting options 5 General display areas 6 Area for displaying the current allocation of the respective membrane key directly underneath 7 Area with membrane keyboard You operate the autoclave by pressing the membrane keys The keys are differently allocated with functions depending on the operating situation soft keys You can see the current key settings in the display field directly above a key Use key 1 and 2 primarily to navigate within the menu These keys are forthwith called navigation keys Keys 1 and 2 can also be used to select additional functions Use keys 3 and 4 to select the option displayed directly above this key Certain hot keys are defined for individual functions There are hot keys for which you are notified on the display and other hot keys which are hidden These are not shown on the display Several of the important hot keys are given below Chapter 2 Device Description MELAG Current operating situation program DOCU Menu Logging list Immediately before starting a program Immediately before starting a program In all menus and displays Running program After the operator has terminated the Briefly simultaneously Opens the door after a program termination Hot keys Function explanation press key 1 CONFIRM and key 3 OPEN see page 25 Manually terminate program Press each one of the Sort the list keys 1 to 4 Key 1
72. r for use of 40295 MELAprinf 42 Water stop valve Water stop valve 01056 54 Appendix B Symbols on the autoclave MELAG Appendix B Symbols on the autoclave stir Chem The manufacturer of the apparatus declares with the accompanying S sticker that the medical device corresponds to the basic requirements of the European Standard EN1717 Protection of drinking water from contaminants co tr Konformitat EN1717 GEPRUFT mon aS NORO Miosa Hono oac The symbol of the struck out trashcan identifies a device that may not be disposed with domestic waste An appropriate and competent disposal must be carried out by the marketing party With the designation of an apparatus with this symbol the manufacturer furthermore declares that he satisfies all requirements of the law concerning the release withdrawal and environmentally compatible disposal of electric and electronic appliances device corresponds to the basic requirements of the German Medical Device Guideline The four digit number means that an approved certification body DEKRA monitors the product certification CE2 With the CE sign CE 0124 the manufacturer declares that the medical With the CE sign CE 0035 the manufacturer declares that the medical C 0035 device corresponds to the basic requirements of the German Printing Device Guideline The four digit number means that an approved certification body TI Rheinla
73. reely accessible see above Figure 8 Look at the LED to the lower right next to the card slot LED see Figure 10 when logs are stored on the CF card the red LED lights up in irregular short intervals If this is the case wait until the LED goes out permanently Press on the ejection button below the card slot and remove the CF card Ejection button for the CF card 3 Figure 11 Ejection button for CF card Chapter 5 Logging MELAG Text and graphic log issue Requirements for the automatic issue of text protocols immediately after program end Optional issue of the graphic log The values set here are effective only ifthe respective output media for the text log have been selected Graphic logs CF Card WES CFC registration interval 00001 PC registration interval 00001 PC backup interval ET ioie Push the protective cover back into its initial position and thereby close the card slot Automatic immediate log output If you want to issue the associated text and graphic protocols automatically after the end of a program on an output medium use the automatic logging with immediate issue As delivered the autoclave is set to automatic protocol issue of both the text and graphic protocols via the CF card immediately after the program has ended The following requirements must be fulfilled for the log ouput immediately after the end of
74. rned off or filter in the cellar clogged If available leak water alarm not functioning FA1 Ambient temperature too high Ventilating louvers covered minimal edge spacing 5 centimetres not maintained Door is permanently open WV4 See event 123 FOY1 ACOUT1 main heating or ACOUT2 regular FOY2 heating electrical supply interrupted FOY1 FOY2 can occur in alternation See event 123 Do not switch off autoclave at the mains switch while a program is running Check building side installation operate autoclave on a separate electric circuit Upon repeated occurrence inform your specialist dealer Upon repeated occurrence inform your specialist dealer Upon repeated occurrence inform your specialist dealer Upon repeated occurrence inform your specialist dealer Observe installation instructions see page 15 Set up location requirements Check loading observe instructions for loading see page 22 Load autoclave Check load see page 20 Load the autoclave Check power supply Open intake for cooling water Examine coolant hose Check shut off cock for house water connection or have it checked Pull power supply line of the water stop valve from the wall socket and plug it in again after 30 seconds switching sound at the leak water valve black box at the faucet must be audible Observe installation instructions see Page 15 Set up location requirements Close the door 1 Pres
75. rom their own heat after removal from the autoclave Sterilization phase is finished From a distance you can recognize from the display whether the sterilization phase is already successfully completed The first square on the progress bar which symbolizes the time course during the program is then displayed in black and shows 0 min for the time until sterilization end Below you see Program successful The sterilization is not successful if it was terminated by the operator or aborted by the system in the event of an error At a system abort the system puts the double jacket into a pressureless state Therefore a system abort takes longer to complete than a termination executed by the operator 25 Chapter 4 Sterilization Drying phase The autoclave does an excellent job of drying the items to be sterilized In the event of difficult drying tasks it might however be necessary to take the following measures to further improve drying Improve drying results Load the autoclave correctly for drying Place items wrapped in clear plastic or paper upwards like filing cards Observe the section on page 20 Load the autoclave Use the package holder where applicable Activate the function Additional Drying Observe instructions under Additional drying on page 23 Program is finished The chamber pressure is adapted to the ambient pressure at the end of a program If the program was successfully finished an appropriate
76. s Chapter 2 Device Description MELAG Overview of menus and symbols TTT TT Menus Main menu Universal Program Quick Program B Quick Program S Gentle Program Prion Program SPECIAL menu H Vacuum test Bowie amp Dick test Conductivity measurement Draining TT TT DOCU menu Output of stored logs on L Logging list Last log Daily log file Log files of the week Log files of the month All program logs Last error log Error logs for the day Error logs for the week Error logs for the month a a aia nia i i a i a a i aia a a All error logs Legend log file Status log System log CF card formatting L Return to Main Menu SETUP menu H Water supply H Automatic logging CF card Computer MELAprint Immediate output Batch format LAN TCP IP FTP L Graphic logs L Date Display contrast Language Energy saving mode fea Sl a eT T TT TT INFO Menu L many important information texts DIAGNOSIS SERVICE L Symbols Universal Program Quick Program B Quick Program S Fa m aS Gentle Program Prion Program SPECIAL Menu o o a a a odpo ile eo Vacuum test gt 4 ole A Bowie amp Dick test Conductivity measurement Draining double jacket L DOCU menu aa Return to Main Menu D SETUP menu 0 INFO menu ll Additional drying ay Err
77. s counters measured values etc LEG Legend log Contains all step initials which are used in the logs of the sterilization programs DEM Demo log Log of a successfully concluded simulated program in DEMO mode only for presentation purposes DES Demo error Log of a terminated simulated program presentation Finding logs After a log output you will find a directory on the storage media CF card or PC The name of this directory consists of five characters e g 44D0J These characters encrypt the serial number of your autoclave The directory is therefore also called the device directory A device directory has subdirectories which are named after the months of the log creation e g 04_2006 In the subdirectories you will find all the logs generated in the respective month Every log file name like the device directory begins with the five characters of the encoded serial number e g 44D0J The autoclave checks the output medium at every log output If it does not already exist the autoclave automatically creates a device directory with the encoded serial number and a subordinate month directory The device directory is created directly on the CF card and thus without a superior directory If you output the logs on a PC then the device directory is created in the directory which is specified in the FTP server program For very simple FTP servers it is the directory in which the FTP server program itself is locate
78. s of the fractionated vacuum method This ensures the complete and effective wetting or penetration of the items to be sterilized with saturated steam This method makes it possible to sterilize all kinds of loads which occur in a physician s medical practice To generate the sterilization steam the autoclave uses a double jacket steam generator Once heated up it provides permanent steam The walls of the sterilization chamber thus have a defined temperature The sterilization chamber is protected from overheating and you can consecutively sterilize large quantities of instruments or textiles very rapidly and achieve excellent drying results The autoclave works with a one way feed water system This means that it uses fresh purified feed water for every sterilization run The quality of the feed water is constantly monitored via integrated conductivity Chapter 1 Performance Specification Automatic feed water supply Optimal drying for wrapped items to be sterilized Optimized total operating time High degree of safety by extensive safety devices Additional function check Effective batch documentation measurement This prevents stains on instruments and soiling of the autoclave assuming the instruments have been carefully prepared The supply with purified feed water for the steam production is automatically provided from an internal supply tank or a water treatment unit e g MELAdem 40 MELAd
79. s reset button overheating protection page 7 Figure 1 10 again 2 Acknowledge error message 3 Switch Chapter 9 Errors MELAG Event 192 231 239 248 351 377 386 387 394 395 396 408 414 Hissing from the SV emergency release can occur with E179 FOY5 WW29 Notice of following rinsing procedure Rinsing condition in the feed water tank should be produced WCFO In the following situations no CF card is plugged in CF card is activated in the SETUP Menu as output medium and immediate output is on YES or Log output is started from the DOCU Menu and CF card is specified as output medium or Formatting of the CF card WCF 1 Vacuum test at residual moisture in the chamber or with load MX1R WART Two years have elapsed since the initial commissioning or since the last have been completed Attempt to output log over the printer but no printer is connected WMP8 Internal memory of the autoclave for the logs of the completed programs is almost full Month directory on the CF card is full more than about 500 logs maintenance or 3000 sterilization programs the autoclave off and then again on continue sterilization or conduct an empty sterilization If this is not successful it is necessary to switch on the vacuum pump Top off water storage tank with feed water or ensure water supply of the water treatment unit Plug CF card in card slot see page
80. seam tears open during sterilization extend the sealing cycle of the package sealing device or weld a double seam Non observance can ultimately lead to unsterile instruments and thereby to the endangerment of the health of patient and practice team Multiple wrapping The autoclave works with the fractionated 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 are on the bottom Transparently wrapped sterilization packages and paper packaging on the top exception in combination with textiles on the bottom Transparent sterilization packages if possible vertically endwise and if this is not possible with the paper side facing downwards Vacuklav 41 B Vacuklav 43 B Instruments Textiles Instruments Loading variant 6 trays depth 290 mm max 6 trays depth 420 mm mounting C 3 Steriliz containers 15K max 6 Sterilization containers 15K 3 Steriliz containers 15M max 3 Sterilization containers 15M 2 Steriliz containers 15G max 2 Sterilization containers 15G 3 Steriliz containers 17K max 6 Sterilization containers 17K max 3 Sterilization containers 17M max 1 Sterilization containers 17G 3 swab drums 17R max 3 swab drums 17R max 2 Sterilization containers 23M max 1 Sterilization containers 23G 2 swab drums 23R max 2 swab
81. sion 2 4x 1 edition September 2006 Responsible for the contents Engineering Department MELAG Medical Technology GeneststraRe 7 10 10829 Berlin Germany E mail info melag de www melag de 2006 2009 MELAG Berlin Document BA_2_GB_41B_43B doc Revision 3 09 0187 Subjects to technical changes MELAG Foreword Thank you for deciding to buy this premium class MELAG autoclave This User Manual describes both the autoclaves Vacuklav 41 B and Vacuklav 43 B They are identical except for their chamber depth and device depth Device name The device name autoclave is used in this User Manual to designate the steam sterilizers Vacuklav 41 B and Vacuklav 43 B User Manual The User Manual contains important safety instructions and information which you need to operate the autoclave Read these instructions carefully and thoroughly in proper sequence Avoid dangers Please read all the safety instructions attentively before using the autoclave About this manual symbol Meaning Explanation Indicates a dangerous situation which if not avoided Danger Risk to health _ could entail slight to life threatening injuries Indicates a dangerous situation which if not avoided Observe could entail damage to the instruments the practice without fail equipment or the autoclave Important information Indicates important information Table 1 Meaning of the symbols used in this User Manual Example of emphasis
82. ssure 0 81 bar 14 min Program successful until drying end e semne DETAILS STOP Sterilization not successfully finished Program abort by the system You manually terminate a running program in any of the phases m Please note that hot water steam can escape upon opening the door after you terminate a program depending on the time of the termination 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 In case of non observance you can suffer burns To terminate a running program press the STOP key and confirm with YES After a short time as shown on the display you can open the door by simultaneously briefly pressing the CONFIRM and DOOR OPEN keys If you terminate a program before the beginning of drying then the items to be sterilized are still unsterile A cautionary note appears on the display The log reports that the sterilization was NOT successful In the drying phase you can terminate the program with the STOP key without the autoclave registering an error You must then especially for wrapped sterilized items expect insufficient drying Sufficient drying is a prerequisite for sterile storage Therefore if possible let programs with wrapped items to be sterilized continue up to the end of the drying phase In a quick program sterilized unwrapped instruments dry f
83. ster fill up the water storage tank The feed water must have a quality at least according to VDE 0510 see page 41 Use qualitatively high grade feed water If you employ a water treatment unit e g MELAdem 40 MELAdem 47 and the water feed is closed then open it up If the water storage tank of the MELAdem 47 is empty turn the water feed tap on at least one hour before the sterilization If the autoclave is still not switched on switch it on at the mains switch page 7 Figure 1 7 See here as of page 9 Switch on autoclave and After switching on If you would like to use the automatic logging feature with a CF card as the output medium and the MELAflash CF card is still not plugged in plug it in the card slot see page 29 Plug in and remove CF card Manufacturer s Observe the manufacturer s recommendations from MELAG on the routine recommendations for daily operation of Class B autoclaves routine operation Prepare items to be sterilized A significant prerequisite for the secure disinfection and sterilization of sterilizing materials is the appropriate cleaning and maintenance of the items to be sterilized according to the manufacturer s instructions Furthermore the materials cleaning agents and processing procedure employed are of significance i Possibly sterilize textiles and instruments separately from each other in Notice separate sterilization containers or sterilization packages Chapter 4
84. t of the health of the patient and the practice team The MELAG sterilization containers satisfy all requirements for successful sterilization and drying They are perforated in the lid and in the floor and are equipped with disposable paper filters If possible stack only sterilization containers of the same size on top of each other where the condensate can run off to the side at the walls m When stacking the sterilization containers take care that the perforations are not covered In case of non observance the condensate cannot drip off to the vessel bottom It would soak sterilizing materials lying underneath The consequence would be bad drying results This can ultimately lead to unsterile instruments and thereby to the endangerment of the health of the patient and the practice team Soft sterilization wrapping can be sterilized in sterilization containers as well as on trays When using soft sterilization packages such as e g MELA oF observe the following instructions m Order soft sterilization packages vertically standing and at a small interval to each other Do not lay several soft sterilization packages flat on top of each other on a tray or in a container m fthe welding seam tears open during sterilization then it might be that the wrapping was too small If this is not the case re wrap the Chapter 4 Sterilization MELAG instruments and sterilize them once again m fthe welding
85. terilization programs MELAG Chapter 2 Device Description In this chapter you learn which components are included in the standard scope of delivery which components the autoclave contains what safety devices the autoclave has how the operating elements are designed and how you should use them how the menus of the user interface are structured which acoustical signals the autoclave emits what kind of water supply the autoclave needs Scope of delivery Standard scope of delivery Optionally Vacuklav 41 B or Vacuklav 43 B User Manual Technical Manual Record of installation and setting up Warranty certificate Pressure device directive certificate Manufacturer s inspection report 1 Mounting for trays or cassettes 1 hose for draining the internal storage tank 1 Tray lifter 1 Allen wrench for emergency opening of the door 1 Torx wrench to remove the carrying strap Trays Standard tray cassette and lifter Additional tray mounts MELAflash CF card MELAflash CF card reader Chapter 2 Device Description MELAG Equipment views Front view Rear view 21 22 23 Figure 1 Front and rear view Protective cap for slot of the gt CF card Control panel Door pivots opens to the left Protective cap for manometer to display the pressure of the double jacket steam generator Cap for emergency opening of the door Draining hose covering of the suppl
86. tic logging is ACTIVE INFO EDIT BACK CONTINUE Subsequent output of stored logs With the DOCU Menu you have the possibility of subsequently outputting logs independent of the time of a program end You can employ activated output media or another output medium for automatic logging in the SETUP menu This function is not possible for graphic protocols Below is an example of how you can deactivate the automatic logging with immediate output corresponds to the state on initial delivery of the autoclave if you e g would like all text logs of the completed programs to be output collectively once a week Initial state for the example In the SETUP Menu Automatic logging the CF card is activated as output medium and immediate output is on YES Navigate in the main menu with the navigation keys to the symbol for the SETUP Menu Press SELECT The SETUP Menu is opened Go with the navigation keys to the menu item Automatic logging The selection frame is on Automatic logging ACTIVE Press EDIT A notification for automatic logging appears Press CONTINUE in order to carry on Go with the navigation keys to Immediate Output Immediate output YES appears framed Press EDIT Press a navigation key in order to change the value now represented in inverse to NO Press OK to confirm this modification Press CONFIRM Go with the navigation keys to Exit MENU and SAVE Press OK In the following example
87. tion by pathologically modified proteins is ae single and suspected e g Prion A multiple Creutzfeld Jacob jprogram wrapping BSE 134 C about 38 min 15 min 6kg 7kg Textiles 2kg 41 B 2 5kg Larger quantities of 43 B single and ae instable ee TF z instable Gentle He i multiple goods e g plastic goods program _ wrapping rubber articles 121 C about 36 min 15 min 6kg 7kg single Single wrapped wrapped wg BS and unwrapped long narrow bore max 1 5 kg Quick A instruments no hollow bodied unwrapped program B i textiles instruments 134 C about 12 min 6 min 6kg 7kg Simple solid instruments amp only transmission Quick K unwrapped no instruments simple program S textiles hollow bodies about 12 min 2 min 6kg 7kg 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 Table 11 Overview of the application areas of the sterilization programs 22 Chapter 4 Sterilization MELAG Additional drying ult Deactivate additional drying Pre selection start time a Warning 08 20 2006 11 20am 117 26 Universal program running Chamber temperature 84 7 C Chamber pressure 0 78 bar 16 min min until drying end eee DETAILS STOP The program specific drying times guarantee very good dry
88. us materials such as textiles As a function check you can routinely conduct the verification of steam penetration For this purpose use the test program Bowie amp Dick test Diverse test systems are offered by specialist dealers for the Bowie amp Dick test Conduct the test according to the manufacturer s instructions of the test system Start the program Bowie amp Dick Test from the SPECIAL Menu Validation The guidelines for the validation of small sterilizers have still not been conclusively specified 45 MELAG 46 Chapter 9 Errors In this chapter you learn Which type of messages exist What you should do in case of errors What you can do before calling the Hotline What you can do if there are bad drying results Danger A warning is not an error Not all messages which appear on the display are error messages Symbols which are shown with a message in the right upper corner of the display indicate whether it is a notification a cautionary warning or an error message Warning messages and error messages are shown on the display with an event number This number serves for the identification Messages Many messages are communications which serve for your Information Messages are not error messages or warning messages Such information supports you in the operation of the autoclave Messages are symbolized by an envelope Warning messages Warning messages are displayed when ne
89. uum test Conduct a vacuum test in the following situations Once weekly in routine operations At initial commissioning After longer operating pauses Chapter 8 Function test MELAG Incase of a respective error e g in the vacuum system The test serves to determine leaks in the autoclave The leakage rate is determined Conduct the vacuum test with a cold and dry autoclave as follows Turn the mains switch on to power the autoclave page 7 Figure 1 7 Inthe main menu navigate with the navigation keys to the SPECIAL Menu Press the key SELECT Proceed with the navigation keys to the symbol for vacuum test Press START The chamber is evacuated until the pressure for the vacuum test is achieved An equilibration time of five minutes and a measurement time of ten minutes follow The rise in pressure in the chamber is measured within the measurement time At the end of the measurement time you will see a message with a specification of the leakage rate at the display If the leakage rate is too high an appropriate message is issued on the display Press DOOR OPEN and then close the door With the navigation keys go in the SPECIAL Menu to the symbol for BACK to the Main Menu and subsequently press SELECT in order to leave the SPECIAL Menu and return to the main menu Bowie amp Dick test The Bowie amp Dick test serves the verification of the steam penetration of poro
90. y tank Mains switch concealed accessible from the side Ethernet 1 data connection Back foot of the unit fixed Reset button overheating protection Front foot of the unit adjustable behind covering Tank filler cap Ethernet 2 data connection Ethernet 3 data connection can be retrofitted Power cable Emergency overflow Safety valve chamber Sterile filter Safety valve double jacket One way drain Purified feed water inlet for MELAdem swivelling threaded fitting for hose 8x1 alternatively straight Connection pressure discharge Cooler Chapter 2 Device Description Interior view Chamber Mounting to hold the load Door spindle Threaded bushing Chamber sealing surface Door seal Door plate Figure 2 Interior view Effective capacity The autoclaves Vacuklav 41 B and Vacuklav 43 B differ only with respect to the respective depth of the units As a result their effective capacities are different Diameter Depth Volume Table 4 Dimensions of the effective capacity usable space Mountings for the load The autoclave is always delivered with a mounting to hold trays or cassettes The mounting C is standard and can hold either six trays or three standard tray cassettes rotated by 90 The mounting B can hold four standard tray cassettes or four trays The mounting D can hold two high cassettes e g for implants or four trays rotated by 90 F

Melag Vacuklav 41B,43B - User manual

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