Home

- Frank`s Hospital Workshop

1. Space requirements Euroklav 23 VS Euroklav 29 VS Width A 42 5 cm A 42 5 cm Height B 48 5 cm B 48 5 cm S a Sy Depth C 69cm C 61 cm T a z D 43 5 cm D 32 cm y o i E 9 cm E 12 cm El A D Le c fe F 10cm F 10cm G 10 cm G 10 cm maximum acoustic power for Euroklav 23 VS and Euroklav 29 VS lt 52 dB A Additional space for feed water supply Eg Space requirement for water treatment unit Other than for the autoclave the water treatment unit for the feed water supply require space NOTICE In no case may you subject the water storage tank to sunlight This way you avoid algae formation The maximum suction height from the external storage tank is 1 5 metres MELAdem 40 can be directly hung on to the autoclave on the side The attachment can be next to the autoclave or above or below the autoclave MELAdem 47 Attachment next to the autoclave or above or below the autoclave e g lower cabinet delivered with water storage tank Water treatment unit Width Height Depth Diameter MELAdem 40 32 cm 35cm 15cm MELAdem 47 module housing 39 cm 47 cm 15 cm MELAdem 47 water storage tank 51 cm 24 cm A Danger of injury Connections required m The electric connections and connections for feed water and used water may only be completed by a specialist technician Non observance could lead to a short c
2. Flow filter soiled Check flow filter lower front on the chamber right behind the door On repeated occurrence notify your specialist dealer Chapter 9 Errors MELAG What you can do What you can do What you can do No display on the screen After switching on the autoclave the display remains empty Check whether the power plug is correctly in the socket Check the supply voltage at the socket f necessary switch the instrument securing at the lower front of the autoclave see page 10 Fig 1 7 off Follow the instructions in the technical manual in Exchange device safeguards Too large feed water consumption The feed water consumption is dependent upon the program and the loading of the autoclave Check the correct set up of the autoclave If necessary adjust the tilt of the autoclave by further screwing out the front feet of the unit The floor of the vessel must be free Where applicable remove fallen instruments filter paper etc Bad drying results Apart from a proper device function the drying process depends decisively on the correct setting up and loading of the autoclave Check the correct set up of the autoclave If necessary increase the tilt by further screwing out the front feet of the unit The floor of the vessel must be free Where applicable remove fallen instruments filter paper etc The tank filter is clogged If necessary check and clean it
3. Water according to VDE 0510 Eg A Warning For retention of value and functional reliability 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 DIN EN 13060 Appendix C VDE 0510 In case of non observance stains or damage on the instruments can arise and the functional readiness of the autoclave 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 NOTICE Feed water which you can inexpensively produce with the osmosis processes with MELAdem 40 or with the ions exchanger MELAdem 47 or by distillation with MELAdesf 65 satisfies the requirements on the feed water Exchange the door seal If the door seal shrinks or is wavy it is necessary to exchange the door seal The consequence can be poorly sealed areas which can lead to the leakage of steam or cause a too high leakage rate in the vacuum test Open the door of the autoclave and take the old door seal out The door seal is only inserted in the groove of the door plate page 11 Fig 2 5 Set the new door seal Art No 58510 in the groove in such a way that the wider sealing surface shows toward the chamber side IMPORTANT Observe wit
4. C 0124 C 0035 af The manufacturer of the apparatus declares with the accompanying sticker that the medical device corresponds to the basic requirements of the European Standard EN1717 Protection of drinking water from contaminants 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 With the CE sign CE 0124 the manufacturer declares that the medical device corresponds to the basic requirements of the German Medical Device Guideline The four digit number means that an approved certification body here DEKRA monitors the product certification With the CE sign CE 0035 the manufacturer declares that the medical device corresponds to the basic requirements of the German Printing Device Guideline The four digit number means that an approved certification body here TI Rheinland Berlin Brandenburg monitors the product certification
5. Logging MELAG Program Start Stop Me NO O Header Values of the program steps Summary By again pressing the KEY S you completely leave the menu and return to the starting position of the display Display protocol memory With a connected and initialised printer or another output medium you can verify how many logs are already saved in the log memory of the autoclave Proceed as follows Select the SETUP Menu Function by short simultaneous pressing of the KEYs and The display shows Function Last batch number Navigate with the KEY or until on the display Function Batch output is shown and press the KEY P Navigate with the Key or up to the display for the Storage Occupancy see left Display Figure are shown n order to leave the menu again press the KEY S twice Read log files correctly The head of the program listing includes the general fundamental information for the completed program such as for example current date the selected program the daily batch number and the autoclave type During the program the program sequence phases are recorded with the accompanying values for steam pressure temperature and time relative to the program start The summary states whether the program was successfully concluded Furthermore the values of the required sterilization time the sterilization temperature and the pressure including its maximum devia
6. Porous small parts Made of materials which can absorb fluids e g liquids Pre vacuum method iln contrast to the fractionated vacuum method a vacuum is created only once to remove the air from the sterilization chamber not so suitable for complicated hollow bodies such as Type A Process evaluation system Also self monitoring system observes itself acts during the programs compares sensors with each other Pulsating overpressure drying Drying method which removes moisture from the chamber and the items to be sterilized by alternating between air entry and discharge RKI Robert Koch Institute Self Monitoring system Process evaluation system Separate steam production The steam generator is located outside the sterilization chamber The sterilization chamber is protected from overheating in this way Simple wrapping Wrapped once e g instruments sealed in a foil contrasted to Multiple wrapping Software non material components of a EDP system e g computer programs Soft sterilization package e g paper bags or clear plastic sterilization packages Solid Without 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 accordi
7. Euroklav 23 VS Euroklav 29 VS Instruments Textiles Instruments Textiles Greatest weight per single piece 2 kg 1 kg 2kg 0 8 kg Loading variant mounting A max 5 trays depth 420 mm max 5 trays depth 290 mm max 6 sterilization containers 15K max 3 sterilization containers 15K max 3 sterilization containers 15M max 3 sterilization containers 15M max 2 sterilization containers 15G max 2 sterilization containers 15G max 6 sterilization containers 17K max 3 sterilization containers 17K max 3 sterilization containers 17M max 1 sterilization containers 17G max 3 swab drums 17R max 3 swab drums 17R max 1 sterilization container 23G max 2 sterilization containers 23M max 2 swab drums 23R max 2 swab drums 23R max 2 sterilization containers 28M max 2 sterilization containers 28M max 1 sterilization containers 28G max 1 sterilization container 28G max 3 standard tray cassettes max 3 standard tray cassettes Maximum total weight 4kg 1kg 3 kg 0 8 kg Mountings trays sterilization containers norm tray cassettes from MELAG see Appendix A Accessories Close the door When closing the door of the autoclave observe the following instructions Close the door with light pressure against the chamber flange and simultaneously press down the sliding closure grip Select program Select by rotating between the initial state and the desired program with the pr
8. 1 L D 5andL 5mmor a double sided open body for which applies 2 L D 10 andD 5 L hollow body length D hollow body diameter DIN EN 13060 Initialization Creation of a certain initial state of the software at start up Integrated steam generation The steam generator is located directly on the floor of the sterilization chamber 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 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 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 mass for their sterilization in a sterilizer designed according to DIN EN 13060 DIN EN 13060 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
9. MELAG Technical Description Autoclave Euroklav 23 VS Euroklav 29 VS as of software version 4 06 Dear doctor We thank you for your confidence demonstrated by the purchase of this autoclave More than 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 400 000 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 Technical description 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 Technical description before you start operation of the autoclave The instructions contain important safety precautions Make sure to keep the Technical description near to the autoclave The instructions are a part of the product Technical description of Euroklav 23 VS Euroklav 29 VS
10. MELAG Medical Technology Berlin Valid for Euroklav 23 VS Euroklav 29 VS as of software version 4 06 1st Edition October 2007 Responsible for the contents Engineering Department MELAG Medical Technology Geneststrake 9 10 10829 Berlin Germany E mail info melag de www melag de 2007 MELAG Berlin Document BA_2_GB_23VS _29VS doc Revision 1 07 1063 Subject to technical changes MELAG Device name Foreword Thank you for deciding to buy this MELAG autoclave This Technical description describes both the autoclaves Euroklav 23 VS and Euroklav 29 VS They are identical except for their chamber depth and device depth The device name autoclave is used in this Technical description to designate the steam sterilizers Euroklav 23 VS and Euroklav 29 VS Technical description The Technical description 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 Symbol Meaning Explanation Risk to health Indicates a dangerous situation which if not avoided could entail slight to life threatening injuries Danger Observe Indicates a dangerous situation which if not avoided without fail could entail damage to the instruments the practice Warning equipment or the autoclave Important
11. Error 14 No feed water see warning text Warning no feed water however this error appears after the start of a program 50 Chapter 9 Errors MELAG Error message Possible causes What you can do Error 18 Sensor Input The device internal inspection of the sensors for temperature pressure or conductivity resulted in a too large deviation the message can occur when the device is switched on or during a program On repeated occurrence notify your specialist dealer Error 21 Preheating Error 22 Overheat Preheating The monitoring time from switching on the pre heating until the achievement of the respective pre heating temperature was exceeded The maximum preheating temperature was exceeded On repeated occurrence select option Automatic pre heating No see page 23 and notify specialist dealers On repeated occurrence select option Automatic pre heating No see page 23 Select automatic pre heating and notify specialist dealers Error 23 Current Monitoring time for the pressure release in the outflow procedure during fractionations was exceeded Flow filter soiled Check flow filter lower front in the chamber floor On repeated occurrence notify your specialist dealer Error 26 A D converting The maximum admissible deviation of the computer internal signal conditioning A D converting was exceeded On repeated occurrence notify your specialist deal
12. 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 a Activate the pre heating see page 23 Select automatic pre heating Employ the function Additional Drying see page 24 Additional Drying 53 MELAG 54 Glossary Air leakage checking the air leakage Air leakage is a poorly sealed 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 of 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 Authorized persons Medical specialist dealers technician from depots or with customer service designated by MELAG who were trained by MELAG Heating up period After switching on the autoclave or after starting a sterilization program it is the time required for heating up the steam generator before the sterilization process starts duration depends on the temperature of the sterilizing process Batch Collection of the items to be sterilized that together passed through one and the same sterilization program Bowie amp Di
13. 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 What kind of water supply the autoclave needs Scope of delivery Standard scope of delivery As option Euroklav 23 VS or Euroklav 29 VS Technical description Technical Manual Warranty certificate Manufacturer s inspection report Pressure device directive certificate Record of installation and setting up 1 Mounting for trays or cassettes 1 hose for draining the internal storage tank 1 TORX wrench for removing the carrying strap 1 lever for emergency unlocking of the door 1 tank filter key 2 replacement device safeguards on the inside door of the autoclaves Trays Tray lifter Standard tray cassette and lifter Additional tray mounts Log printer MELAprint 42 MELA flash CF card writer with CF card and card reader MELAnet Box Chapter 2 Device Description 10 Front side OO OO 1 ir eae m3 YL 4 0 r 7 iF Sl EI 8 9 Back side 10 11 12 13 14 15 16 Fig 1 Device views 17 Device views Operating and display field Door pivots opens to the left sliding clos
14. Indicates important information information Example of emphasis Meaning Explanation Conductivity Glossary entry Words or phrases marked with an arrow are measurement explained 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 to another text section within this reference Technical description Figure 1 5 Cross Reference to a detail in a figure in the example to reference Part No 5 in Figure 1 Instruction Mains cable and power plug 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 Technical description m Do not sterilize any liquids with this autoclave m Never damage or change the mains cable or power plug 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 Only have the autoclave set up installed and commissioned by people aut
15. steps Press the Key S Confirm the following prompt Stop program Repeatedly press Stop withthe Key S The termination is confirmed with Drying stopped on the display NOTICE The confirmation prompt is shown for about 5 seconds on the display If the key is not repeatedly pressed the program continues with the normal process After the ventilation of the chamber with a corresponding display text the message Universal Program run successfully follows in alternation with Last batch number xx and quit with If a printer or another output medium is connected to the autoclave and the Immed Output is set to yes a reference to Drying stopped is issued to the logging printout Sterilization phase is finished You can recognize on the display whether the sterilization phase has successfully completed The remaining time of the sterilization phase is displayed in alternation with the specification of the pressure and temperature 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 chamber into a pressureless state NOTICE If the program is terminated by the operator a warning text appears If the program is aborted by the system an error message is displayed Drying phase The autoclave does an excellent job of drying the items to be sterilized In the event of difficult drying tasks it might
16. the Key P in order to start the printout of the selected program The display shows Output After finishing the output the display again shows Output stored cycles In case you would like to leave the submenu without printing press the KEY S NOTICE A termination during the output on the log printer is only possible by disconnecting the instrument at the mains switch or interrupting the power supply of the printer n order to leave the menu likewise press the KEY S The display shows the setup menu Function Batch output By again pressing the KEY S you completely leave the menu and return to the starting position of the display In order e g to suppress the warning text Protocol memory full for preset option Immediate output No the saved logs can be manually deleted In the following example you can read how you can delete all saved logs Select the SETUP Menu Function by short simultaneous pressing of the keys and The display shows Function Last batch number Navigate with the KEY or until on the display Function Batch output is shown and press the KEY P Navigate with the KEY or until on the display All cycles delete is shown Press the Key P in order to delete all logs now n order to cancel the submenu without deleting press the KEY S n order to leave the menu after deletion press the Key P The display shows Function Batch output Chapter 5
17. you can verify the autoclave for sufficient steam penetration of porous sterilizing materials e g textiles With Conductivity measurement you can verify the water quality of the feed water The autoclave has an internal log memory which can save up to 40 program cycles All data of the completed 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 Chapter 1 Performance Specification Overview of sterilization programs Type tests Universal Quick Gentle Prion Program Program S Program Program Program type as per Type S Type S Type S Type S DIN EN 13060 Dynamic pressure test of the sterilization X X X X chamber Air leak X X X X Empty chamber test X X X X Solid load X X X X Porous partial load X X X Porous full load Hollow body B X X X X Hollow body A Simple wrapping X X X X Multiple wrapping X X X X Drying solid load X X X X Drying porous load X X X Sterilization temperature 134 C 134 C 121 C 134 C Sterilization pressure 2 bar 2 bar 1 bar 2 bar Sterilization time 5 5 min 3 5 min 20 5 min 20 5 min X Conformity with all applicable sections of the standard DIN EN 13060 MELAG Chapter 2 Device Description In this chapter you learn Which components are included in the standard scope of delivery
18. 0 see Operating Manual for the water treatment unit MELAdem 47 and examine the unit On repeated occurrence have maintenance carried out by MELAG customer service or service of the specialist trade Possibly the pre and activated carbon filter must be exchanged in addition For another water treatment unit Exchange module resin cartridge according to the operating manual of the manufacturer On repeated occurrence carry out maintenance NOTICE Initiate program start after completion of the above mentioned work On the first start after maintenance of the water treatment unit this warning text can appear once again since the inlet hose measuring cell are still not completely flushed with fresh water Start no longer possible See warning message Feed water quality bad switch cartridge module Warning Exchange sterile filter min max pressure on ventilation drying is too low high Sterile filter polluted or torn Exchange sterile filter Art No 20160 NOTICE Message comes at the end of the program and in last row on logging printouts Output medium is not ready Protocol memory full The autoclave is operated without output medium although a output medium is registered Output medium is not correctly connected Electric power supply of the printer is interrupted Printer is offline The device internal log memory is allocated max 40 logs possible Select the option i
19. 6840 Sterilization containers 15K depth width height in cm 18 12 4 5 01151 with single use paper aii filters according to DIN 15M depth width height in cm 35 12 4 5 01152 EN 868 8 15G depth width height in cm 35 12 8 01153 17K depth width height in cm 20 14 5 01171 17M Depth width height in cm 41 14 5 01172 17G depth width height in cm 14 14 9 01173 23M depth width height in cm 42 16 6 01231 23G depth width height in cm 42 16 12 01232 28M depth width height in mm 32 16 6 01284 28G depth width height in mm 32 16 12 01285 Swab drums with filter 17R diameter height in cm 13 10 5 00174 Han 23R diameter height in mm 18 14 00233 Package Holder for chamber 25 cm X 45 or 35 cm 22420 22410 Standard tray cassette Perforated depth width height in mm 29 19 4 with filter cloth 00289 without filter cloth 00286 Trays tray 00230 00280 Water treatment units MELAdem 40 ion exchanger 01049 MELAdem 47 reverse osmosis unit 01047 For the MELAflash CF Card printer incl MELAflash CF 01039 documentation card and card reader MELAnet Box 40296 MELAprint 42 log printer 01042 Other Water stop valve 01056 Surface mounted siphon 37410 Device safeguards 16A gRI 57592 All specified articles are available at the specialist dealers 57 MELAG 58 Appendix B Symbols on the autoclave Ag Chemiz c g Konformit t EN1717 GEPR FT enon oon 2 we vere NORD ne
20. AG customer service Feed water supply from MELdem 47 Check water treatment unit possibly open inflow to the unit When the pressure reservoir is empty about 1 h after restart and the message is repeated have the water treatment unit checked by the MELAG customer service Notice At the first start up or re start up this message can occur once since the piping system is still not completely filled restart Attention empty the wastewater tank No start possible left chamber of the storage tank wastewater side is full Empty the left chamber of storage tank wastewater side see page37 Chapter 6 Maintenance Feed water quality bad exchange cartridge module Conductivity of the feed water too high Conductivity 2 40 uS Still possible to start by repeatedly pressing the Key S Feed water supply off 47 Chapter 9 Errors 48 Warning message Possible causes What you can do Feed water quality insufficient No start possible Mixed bed resin pellets consumed MELAdem 40 Switch the mixed bed resin pellets Art No 61026 see Operating Manual for the water treatment unit MELAdem 40 Mixed bed resin pellets in the after ion exchanger 3rd cartridge consumed Mixed bed resin pellets in reverse osmosis facility consumed Conductivity of the feed water too high Conductivity 65 uS MELAdem 47 Switch mixed bed resin pellets Art No 3747
21. Batch output is shown and press the KEY P Navigate with the KEY or until on the display the submenu Immediate output Yes No is shown Press the Key P in order to switch between Immediate output No and Immediate output Yes n order to output logs immediately Immediate printout Yes must be set In order to save the setting and to leave the menu again press the KEY S The display shows Function Batch output By again pressing the KEY S you leave the menu completely and return back to the initial state NOTICE If it is not possible to output a log report for the immediate output because for example the activated output medium is not connected a warning message appears MELAG recommends that you employ the immediate output of logs Output the logs subsequently You also have the option of outputting the logs subsequently and independently from the time of the end of the program You can select whether selected or all saved logs up to 40 logs should be printed For this use the connected output medium e g the log printer In order to subsequently print selected logs of certain programs proceed as follows Select the SETUP Menu Function by short simultaneous pressing of the keys or The display shows Function Last batch number Navigate with the KEY or until on the display Function Batch output is shown and press the KEY P The Menu Batch output Output medium is di
22. Bowie amp Dick test with the KEY P Press the Key S to start the Bowie amp Dick test After successful completion of the program the display shows in alternation with the current batch number of the day and Quit with button After pressing the KEY you can open the door Display water quality You can at all times have the display of water quality shown on the switched on the autoclave also during a running program ANG Say To do this keep the KEY pressed until the display shows the Conductivity The conductivity is stated in uS cm As soon as you release the KEY the display returns to its previous status e g initial state Pre heating temperature of If you press the KEY twice shortly and the second time keep it pressed the chamber the pre heating temperature of the chamber is shown instead of the Conductivity AIN4 Temp preheat Validation The guidelines for the validation of small steam sterilizers are still not conclusively specified Please inform yourself about the current state of this matter in the download area of the MELAG internet site at www melag de 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 no display appears What you can do when the feed water consumption is
23. UPECOWN sisstin etve iaronn 42 ANTELA eLO A E EEE EA E A eect Nos 42 Re startup after change of locality 0 42 Chapter 8 Function teSt s cccssseeeesees 43 Automatic function test 43 Manual function test eeen 43 Testing in daily operation 44 VACUUM testisin tieit tenia praia 44 Bowie amp Dick test ccna sen 44 Display water quality 45 Validation iainih iie deante ieee 45 Chapter 9 Error ccscceseesseeeseessseeseseeeeneenenee 46 A warning is not an erfor necesn 46 Warning MESSAGES ee eeeeeeceesneeeeeeeeeeeeneeeeeeaas 46 Error messages onite ste echt eesti eek ccits heath eehes 46 Before you callarse ieiet 47 No display on the screen cecene 53 Too large feed water consumption seee 53 Bad drying results 53 GIOSSANY A E ieee aoe ei nena 54 Appendix A ACCeSSOSICS ecssseereeseeeenees 57 Appendix B Symbols on the autoclave 58 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 A Danger of burning A Warning Universal use Low time expenditure overheating protection Automatic pre heating Proper use The autoclave is intended for use in every kind of general medical area where no Class B autoclave
24. a copy sent to MELAG Switch on autoclave Turn the mains switch on to power the autoclave page 10 Fig 1 4 After switching on the autoclave with the mains switch the display shows in alternation to the initial state the message Unlocking door with button if the door is closed Directly after having switched on the autoclave and before initial start up remove the trays and accessories from the chamber Press the KEY to unlock the door After pressing the key you can open the door 17 MELAG 18 Chapter 4 Sterilization In this chapter you learn Which prerequisites should be created for a smoothly running sterilization How to switch between internal and external feed water supply How to switch between the one way and circulatory feed water system What you should observe when preparing the items to be sterilized How to 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 to recognise when 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 Create the prerequisites for a smooth and successful sterilization process as follows Provide feed water f you use an internal storage tank for the feed water supply fill this z i with feed wa
25. arameter press the KEY P for the confirmation The current value on the display blinks The value can be increased or reduced with the KEYs and In order to store the value confirm with the Key P The current preset value on the display no longer blinks In order to adjust the other parameters proceed analogously After finishing the settings press the KEY S in to leave the menu On the display the Function Date Time are again displayed By pressing the key S again you leave the menu completely and the display again shows its starting position Use printer as output medium If you want to employ the log printer MELAprint 42 as the output medium connect it to the autoclave as follows Open the white cover of the serial data and printer connection see page 10 Fig 1 6 Turn a coin by a quarter revolution inserted in the locking slot 1 on the white cover Take cover off and fold the interior metal casing to the left Press the metal casing somewhat downwards until it engages and no longer can automatically flip back Connect the cables of the log printer to the printer connection at the autoclave If the printer or a computer is continually connected to the autoclave the data connection cable of the log printer is laid in the cable ducts 2 the metal casing retracted and the cover is closed again This provides a comfortable external cable connection to the printer Close the log pr
26. ation with the autoclave a test output can be carried out Select the SETUP Menu Function by short simultaneous pressing of the keys and The display shows Function Last batch number Navigate with the KEY or until on the display Function Batch output is shown Press the Key P to select the submenu Batch output Output medium is displayed and press the KEY P for confirmation Navigate with the KEY or until the display Test output is shown In order to start the output press the Key P An appropriate display with Test output appears n order to break cancel the test output or leave the menu after finished printout press the Key S The display shows Function Batch output By again pressing the KEY S you completely leave the menu and return to the starting position of the display 31 Chapter 5 Logging 32 MELAfiash CF Card Schreiber CF Card Prentor output medium MELnet graphic data Program Start Stop Initialisation of the computer output medium Computer S 6 Employing MELAflash as output medium The MELAflash CF Card Writer serves for storage of sterilization logs on the MELAflash CF card The readout of the logs from the CF card to the practice computer is carried out with the MELAflash card reader Additionally you can use the software MELAview for processing the logged data TIP You can download a curre
27. before a program start is kept to the program specific pre heating temperature or maintained at this temperature between two program runs Prerequisite is that the autoclave remains continuously switched on The condensate formation at the chamber wall is reduced and drying is supported The cycle times shorten The automatic pre heating is activated in the factory settings In order to change this setting if desired proceed as follows Select the SETUP Menu Function by brief simultaneous pressing of the KEYS and The display shows Function Last batch number Navigate with the KEY or up to the display Function autom Pre heating is displayed For confirmation press the KEY P The display shows the current preset option e g Pre heating Yes Press the Key P once again switch the display to Pre heating No The pre heating is deactivated n order to end the menu Function autom Pre heating and return to the initial state press the KEY S twice NOTICE MELAG recommends the activation of automatic pre heating 23 Chapter 4 Sterilization 24 Supplonenteaina Program Start Stop selected Universal program Program Start Stop 134 C wrapped Pre vacuum Pre vacuum Program Start Stop 0 72bar 60 C Evacuation phase 1 Fractionation Prooren t 0 69bar 115 C Heating up phase Sterilization phase Sterilization sti
28. btained by ion exchange from normal tap water It is employed here as feed water 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 ISO 11140 1 European standard Sterilization of products for health care chemical indicators Part 1 General requirements DIN EN ISO 11607 1 Standard Requirements on materials sterile barrier systems and packaging systems this standard is a harmonization of the DIN EN 868 Part 1 and the international standard DIN EN ISO 11607 DIN EN 13060 European standard Small steam sterilizers DIN EN 285 European standard sterilization steam sterilizers large sterilizers Display Display device on electronic devices here Graphic display of the control panel Distilled water From lat aqua destillata also designated as aqua dest water which is largely freely of salts organic materials and microorganisms is obtained by distillation evaporation and subsequent condensation from normal tap water or pre cleaned water It is employed here as gt feed water Dynamic pressure test of the sterilization chamber Serves to verify that the rate of the change of pressure occurring in the sterilization chamber durin
29. ck test Steam penetration test with standard testing packet described in gt 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 the 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 Also designated as aqua dem water to a large extent without the minerals which occur in normal mineral or tap water is o
30. d Press the KEY to unlock the door After unlocking the door audible you can open the door and remove the sterilized items 27 Chapter 4 Sterilization 28 Condensate residues on the sterilized items Storage conditions Storage time For connected output medium and Immediate output Yes a logging printout is additionally carried out see page 33 Automatic immediate log output If you remove the sterilized items from the autoclave directly after the end of the program it can happen that slight quantities of condensate moisture are found on the sterilized items Smaller quantities of water 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 Exclusively employ packaging which complies to standards for the sterilized materials Do not store sterilized items in the preparation room For the storage of the sterilized items observe the criteria mentioned 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 alcohol 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 c
31. d water or circulatory system 66 Water system One way Textiles A Danger n order to save the setting and to leave the menu press the KEY S By again pressing the Key S you completely leave the menu and return to the starting position of the display At initial delivery the Feed water supply is set to intern You can choose the one way feed water or circulatory system for your feed water supply from the internal storage tank To do so you must change the setting on the display before starting a program Select the SETUP Menu by brief simultaneous pressing of the keys and The display shows Function Last batch number Navigate with the KEY or up to the display Function Water system is displayed Press the Key P The currently set option appears on the display e g Water system one way To setthe value to Water system circle press the KEY P again n order to save the setting and to leave the menu press the KEY S By again pressing the KEY S you completely leave the menu and return to the starting position of the display NOTICE If the autoclave is supplied with feed water via a water treatment unit you cannot select the menu Function Water system Prepare items to be sterilized A significant prerequisite for safe disinfection and sterilization of sterilizing materials is the appropriate preparation i e cleaning and maintenance
32. ds maximum 5 litres This quantity of feed water suffices for up to 7 sterilizations With the MELAdes 65 distilling unit you can produce feed water in the practice cost effectively A water treatment unit is connected to the domestic water supply It produces 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 have to manually fill the water storage tank The waste water can either be collected in an internal storage tank and manually emptied or automatically drained via the one way drain Chapter 2 Device Description MELAG Water treatment units The water treatment units MELAdem 40 and MELAdem 47 produce the MELAdem 40 and optimal purified feed water quality for the autoclave The selection of the MELAdem 47 respective unit depends on the number of sterilizations per day and the respective loads Both MELAG autoclaves can be supplemented with a water treatment unit a NOTICE Please first consult with MELAG if you would like to employ water treatment units of other manufacturers 13 MELAG Chapter 3 Initial start up In this chapter you learn Who may set up install and start up the autoclave Which prerequisites you must create for setting up installing and starting up
33. e piping by a specialised installation firm Observe the following precautionary measures when handling the mains cable and power plug 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 m 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 authorised 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 the power plug into the socket Chapter 3 Initial start up MELAG Switch on mains After switching on Prerequisites for initial start up The following prerequisites must be satisfied for initial start up The feed water supply must be secured The power supply of the autoclave must be assured Record of installation and setting up NOTICE As documentation of proper setting up installation and setting up as well as for your warranty claim the record of installation must be filled out by the person responsible and
34. e feed water is constantly monitored via integrated conductivity measurement here as well The feed water for generating the steam is automatically supplied via an internal water storage tank or a water treatment unit e g MELAder 40 MELAder 47 The sterilized items are dried with the pulsating overpressure and vacuum drying method 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 verifies pressure and temperature in the sterilization chamber at all times and its door locking system does not permit opening the door when there is overpressure in the chamber A process evaluation system is integrated in the electronics of the autoclave It monitors the process parameters such as temperature time and pressure during a program It monitors the parameters with respect to their limit values at activation and control and guarantees a safe and successful sterilization If one or more parameters are above or fall below the determined limit values the autoclave outputs a warning or fault messages and if necessary aborts the program In the event of an automatic program abort observe the information on the display With the help of the test programs you can conduct an additional function check at any time With the Bowie amp Dick test
35. eaning and disinfection devices e g thermal disinfector Load the autoclave Only if the autoclave is properly loaded can the sterilization be effective and the drying deliver good results NOTICE 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 Employ only packaging materials and systems sterile barrier systems which satisfy the DIN EN ISO 11607 1 Standard You can employ reusable rigid packaging such as standard tray cassettes or soft packaging such as clear plastic sterilization packages paper bags sterilization paper textiles fleece Preferably use sterilization containers made of aluminium Aluminium conducts heat well and thus accelerates drying Chapter 4 Sterilization MELAG A Warning Stack sterilization containers A Danger Soft sterilization wrapping A Warning Multiple wrapping Mixed loads When using closed sterilization containers observe the following instructions for holding the sterilizing materials m Closed sterilization containers must be equipped at least on one side possibly below with pe
36. eing shown on the display The regular drying time is 10 minutes for the Quick Program S 20 minutes for the Gentle Program and for the Universal program and the Prion program 25 minutes Manually terminate program You manually terminate a running program in any of the phases IMPORTANT Do not interrupt a running program by disconnecting the power plug In case of non observance an error message of power loss is displayed when the autoclave is switched back on 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 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 To remove tray cassettes use a tray lifter or gloves The parts are hot In case of non observance you can suffer burns If you terminate a program before the beginning of drying then the items to be sterilized are still unsterile To terminate the program carry out the following steps Press the KEY S Confirm the following prompt Stop program Repeatedly press Stop with the Key S NOTICE The confirmation prompt is shown for about 5 seconds on the display If the key is not pressed again the program continues with the normal process Depending on the point in time of the termination a pressure discharge or ventilati
37. er Error 27 Temp Sens def 1 2 Error 31 System leak The maximum admissible deviation between the two temperature sensors for the steam temperature was exceeded During the program vacuum test the permitted pressure maximum was exceeded very large leak after achieving the evacuation pressure On repeated occurrence notify your specialist dealer Repeat vacuum test if renewed error message notify specialist dealers Error 32 Power loss Sterilize sterile filter The loss of the operating voltage occurred after the start of a program The error message occurs after the operating voltage is again available Check building side installation If no defects are detectable notify MELAG customer service In the event of power failure after a program has been started in overpressure an additional request appears to sterilize the sterile filter since this has become damp and is possibly contaminated with microbes Exchange sterile filter at the back side of the autoclave sterilize the filter in the Quick Program after the expiration of the program plug in the filter again 51 Chapter 9 Errors Error message Possible causes What you can do Disconnection of the autoclave during a running program Only terminate a running program with Key S see also page 25 Manually terminate program Error 33 Pressure drop The maximum switch on time of the steam generator
38. er is measured within the measurement time The evacuation pressure and the equilibration time or measurement time are shown on the display Leak rate Progam 6 After the expiration of the measurement time the chamber is ventilated 0 2 mbar appropriate display message Subsequently the message with specification of the leakage rate is shown on the display If the leakage rate is too high i e above lt 1 3 mbar an appropriate message appears on the display Besides the display shows in alternation with the current batch number of the day and Quit with button After pressing the KEY you can open the door NOTICE For connected log printer or another output medium and the setting Immediate output Yes logging is carried out with simultaneous printout Bowie amp Dick test pas The Bowie amp Dick test serves the verification of the steam penetration of Bowie amp Dick test 134 C 2 2bar 3 5 porous materials such as textiles 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 as follows Switch the device on at the mains switch The display switches into its initial state 44 Chapter 8 Function test MELAG Select the
39. es of the program steps Program sequence phases with the accompanying values for pressure temperature and time relative to the program start Summary Control message Mean sterilization temperature with max deviations Mean sterilization pressure with max deviations Sterilization time maintained Time at the end of the program Information with total cycle counter factory serial number and instrument software version no MELAG 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 How to exchange the door seal What to observe in autoclave maintenance Weekly inspection of chamber door seal mounting chamber sealing surface In case of contaminations Door seal A Warning Housing parts Internal storage tank for feed water Cleaning Examine the chamber including door seal and chamber sealing surface and the mounting for loading page 20 Load the Autoclave once weekly for contaminants deposits or damage If you determine any contaminations draw the existing trays or cassettes and the associated mounting forwards out of the chamber Clean the contaminated parts The door seal must not be greased or oiled It should be kept clean and dry When cleaning the chamber the loading mounting the chamber sealing surface and the door seal observe the following m Switch the au
40. for achieving the control pressure was exceeded On repeated occurrence notify your specialist dealer Error 34 Sterilization TU Error 35 Sterilization TO Shortfall of the minimum permissible sterilization temperature Exceeding the maximum permissible sterilization temperature Operate device with smaller load possibly carry out vacuum test Check door seal for wear On repeated occurrence notify your specialist dealer Carry out vacuum test On repeated occurrence notify your specialist dealer Error 36 Sterilization PU Shortfall of the minimum sterilization pressure Operate device with smaller load possibly carry out vacuum test Check door seal for wear On repeated occurrence notify your specialist dealer Error 37 Sterilization PO Exceeding the maximum permissible sterilization pressure On repeated occurrence notify your specialist dealer Error 38 Sterilization TD Error 41 Current drying Maximum permitted difference between measured and theoretical temperature was exceeded Flow filter soiled On repeated occurrence notify your specialist dealer Check flow filter lower front on the chamber right behind the door On repeated occurrence notify your specialist dealer Error 42 Drying press pump Sterile filter soiled Check sterile filter exchange if necessary On repeated occurrence notify your specialist dealer Error 43 Drying vacuum pump 52
41. g 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 Glossary MELAG 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 FTP engl File Transfer Protocol is a data communication method which serves for the transmission of data from the internet These data can contain programs files or information Special FTP programs FTP clients serve for uploading any data on a server Fractionated flow method Overpressure method in which the air is expelled from the chamber and the items to be sterilized by alternating between steam entry and steam outlet Hollow bodies A One sided open bodies for which applies 1 L D 750 and L 1500 mm or a double sided open body for which applies 2 L D 1500 and L 3000 mm and which does not correspond to the hollow body B L hollow body length D hollow body diam Hollow bodies B One sided open bodies for which applies
42. he feed water Notice Make sure to wipe up and remove any soiling or impurities from the tank with a cloth without leaving any residues If dirt particles are only detached but not actually removed they can get into the dirt particle filter integrated into the drain hose while emptying the wastewater tank Non observance could impair the service life of the dirt particle filter and make it necessary to exchange the filter at short notice The both chambers are emptied as follows Attach the drain hose on a quick fitting connection left of the waste water tank to the right of the feed water tank until this 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 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 Repeat the procedure for the ot
43. her chamber if necessary If the autoclave is operated in the feed water circulatory system the feed water must be changed every week 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 e g residues of disinfectants can clog the filter nozzles and valves of the autoclave and deposit as stains spots or discolorations on the instruments and in the chamber see page 19 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 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 37 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 Chapter 6 Maintenance MELAG A Warning
44. horised 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 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 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 m Check the wrapping of the sterilized objects for damage when removing them from the autoclave If a wrapping is damaged wrap the object again and re sterilize it m Have the maintenance done only by authorized pers
45. hout fail the different widths of the sealing surface Only with correct seating in the groove is a proper closing of the door guaranteed and the chamber tight 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 Comply with the predetermined maintenance intervals Malfunctions at the autoclave can occur on continuation of operation despite the servicing message 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 are checked and replaced if necessary 39 Chapter 6 Maintenance 40 Maintenance intervals The maintenance is carried out according to the maintenance instructions which are relevant for this autoclave Regularly allow for maintenance after each 1000 program cycles or two years At this point in time the autoclave issues an appropriate maintenance reminder message MELAG Chapter 7 Operating pauses In this chapter you learn How quickly you can start sterilization programs in sequence What you must observe for longer operating pauses How to put the autoclave out of operation transport it and re start it No pause times required Longer operating pauses Steriliza
46. however be necessary to take the following measures to further improve drying Load the autoclave correctly for drying Place items wrapped in sterilized clear plastic or paper upwards like filing cards Observe Section Load the autoclave on page 20 Possibly employ the package holder Activate the function Supplement Drying Observe the Section Select additional dryingon page 24 Chapter 4 Sterilization MELAG Program Start Stos Universal Program run successfully Immediate printout Display last batch number Last batch number 6 6 Display total batch number Batch counter VN ge 367 A Danger of burning A Danger Open door 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 notification appears on the display The report of the completed program is issued to the selected output medium for activated immediate output see page 29 Chapter 5 Logging Display batch number After every completed program you automatically see on the display the last batch number of the day This is also shown if the program was terminated by the operator or aborted by the system You can also allow the display of the last batch number whenever necessary Select the SETUP Menu Function by short simultaneous pressing of the KEYs and The di
47. ickly sterilize wrapped instruments or textiles To generate the sterilization steam the autoclave uses an integrated steam generator The sterilizer chamber is protected from overheating and you can sterilize instruments and small quantities of textiles in a short time The cold chamber is preheated on activation of preheating or can be maintained at a specific temperature between two sterilizations This shortens the program time periods and reduces the formation of condensate to give improved drying results Chapter 1 Performance Specification MELAG Internal feed water supply in one way and circulatory flow system Automatic feed water supply Optimal drying for wrapped items to be sterilized Optimized total operating time High safety with extensive safety devices Additional function check Effective batch documentation The autoclave works both according to the feed water one way system as well as the feed water circulatory flow system In the one way system it uses fresh purified feed water for every sterilization run The quality of the feed water is constantly monitored via integrated conductivity measurement This prevents stains on instruments and soiling of the autoclave provided the instruments have been carefully prepared In the feed water circulatory flow system the autoclave works in a more water conserving manner since the feed water is used for several sterilization runs The quality of th
48. inter MELAprinf 42 according to the pertinent operating manual Chapter 5 Logging MELAG Initialisation of the log printer MELAprint 42 output medium MELAprint 66 Test outputs on the log printer MELAprint 42 Test printout 66 In order to be able to print out logs on the connected log printer you must initialise MELAprinf 42 once by making the following setting at the autoclave fthe autoclave is still not switched on switch it on Wait until the display shows the basic settings page 12 Control Panel Select the SETUP Menu Function by short simultaneous pressing of the KEYs and The display shows Function Last batch number Navigate with the KEY or until the display Function Batch output is shown Press the KEY P to select the submenu Batch output Output medium Press the Key P again The display shows Output medium No Output medium in case no printer was yet selected Navigate with the Key or until the display shows as output medium MELAprint For confirmation press the KEY P The display changes back to the menu Batch output Output medium Press the KEY S in order to confirm and return to the menu Function Batch output After renewed pressing of the KEY S the display again shows the initial state In order to verify the functional reliability of the log printer MELAprinf 42 and its communic
49. ircuit and or fire and or water damage and or electrical shock Serious injuries could be the consequence 15 Chapter 3 Initial start up Electrical connection Connected load Eg Waste water drain A Danger of injury Insert power plug into the socket 16 Provide the following electrical connections for the autoclave Electric circuit with 220V 240V and 50 60 Hz 16 A separate fuse protection at least Automat Type B Protection from leakage current 30 mA as of software version 4 07 2600 W for Euroklav 23 VS 2100 W for Euroklav 29 VS software version 4 06 3000 W for Euroklav 29 VS 2400 W for Euroklav 23 VS NOTICE In order to prevent water damage MELAG recommends the use of a leak monitor e g water stop valve from MELAG Art No 01056 The autoclave is connected to the drain via the one way drain see page 10 Fig 1 14 The connection must be located below the autoclave The one way drain hose can be connected as follows To an existing sink drain To a separate drain pipe when using the surface mounted siphon from MELAG Art No 37410 not in the standard scope of delivery You can reorder a 2 m long hose Art No 36585 for the one way drain hose NOTICE The waste water hose must be laid dip free with continuous descent For waste water paths which are longer than two metres we recommend a fixed laying of HT high temperatur
50. is required due to the instruments used and type of packaging According to DIN EN 13060 this autoclave is considered a Class S sterilizer As a universal autoclave it is suited for sterilizing wrapped simple hollow body instruments Hollow Body B and smaller 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 approved 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 basis of the pre vacuum method combined with the fractionated flow method These methods ensure the complete and effective wetting or penetration of the items to be sterilized with saturated steam The procedure can also be used to safely and qu
51. l Installation supply voltage too low operate device on a trial basis on another electric circuit If problem persists notify specialist dealers Error 4 Pressure release Pressure release filter is soiled Check whether the pressure release filter is clogged in chamber bottom in the rear area Beforehand unscrew the filter On repeated occurrence notify your specialist dealer Error 8 Time base Maximum difference between On repeated occurrence notify your specialist the program cycle time and the dealer internal computer clock is exceeded Error 9 Door open The locking sliding handle was Push the sliding closure grip downwards until pushed upwards during a the stop Correct display Door closed running program mae On repeated occurrence notify your specialist dealer Error 10 Overheat Steam Capillary tube regulator level After program termination and immediate start generator control is opened at program this error message can be repeated after a start error message pause time of two minutes immediately after start or during a program run until the On repeated occurrence notify your specialist end of the sterilization the dealer monitoring time until the capillary tube regulator is switched back with water feed from feed water is exceeded Error 12 Door locking Locking pin of the door is stiff Check the smooth running of the door locking pin On repeated occurrence notify your specialist dealer
52. lay steam temperature C Program Start Stop 14 27 12 0 02bar 25 C Function key and Program selection button P Start Stop button S to select set and display special functions to select the sterilization programs test to start programs terminate print date time preheating total batches conductivity acknowledge error KEY for unlocking the door Initial state Feed water with internal storage tank Internal storage tank Distilling unit MELAdest 65 Feed water via water treatment system programs and select or set options programs drying as well as submenus of the special functions control of the special functions The display switches to the initial state after every switch on where the current time and the chamber pressure in bar and the steam temperature in C is displayed Supply with feed water The autoclave requires demineralized or distilled feed water for steam production according to gt VDE 0510 The feed water supply is provided either by an external water storage 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 storage tank for the feed water supply you must fill it manually from time to time At the given point in time the autoclave outputs an appropriate message Only use water according to gt VDE 0510 as feed water The internal storage tank hol
53. ll 2 min 12sec OO Drying phase Select additional drying For difficult drying tasks you can extend the drying time of a program by 50 with the function Additional Drying For this proceed as follows When starting the program simultaneously press the KEY S AND KEY The display shows Supplement drying selected Then the program sequence begins Start program If you have selected a program with the program selection button in addition to the selected program the sterilization temperature is displayed and whether the respective program for packaged or unpacked sterilizing materials is suitable Press the Key S in order to start the program The autoclave checks the transport of the feed water and its conductivity If the Quick Program S is started the warning text Warning only unwrapped instruments is shown on the display If the load exclusively contains unwrapped instruments press the KEY S once again to confirm and start the program Program is running After the start of the program you can track the program steps on the display Chamber temperature and pressure as well as the duration until the end of sterilization or the expired drying time is displayed In the Pre vacuum the air is sucked out by evacuation and steam is conducted into the chamber until a program dependent pressure up to a slight overpressure is reached In the subsequent evacuation phase the fractio
54. medium the computer must be connected with the serial interface to the autoclave Additionally the software MELAview can be installed for the log readout In order to register the computer at the autoclave proceed as described on page 371 Initialisation of the Log Printer Observe that for the output medium in the SETUP Menu Function you must set at the autoclave as output medium Computer Chapter 5 Logging MELAG Prerequisite for automatic immediate output of the logs after the end of the program Immed printout Yes 66 Print selected logs output N Last cycle 66 Automatic immediate log output If you immediately would like to output the associated report automatically on an output medium after the end of a program use the function Immediate output Yes This is not preset in the initial delivery state The following prerequisites must be satisfied for the immediate log output after the end of a program As output medium the computer the log printer MELAprinf 42 or the MELAflash CF Card Writer must be connected and initiated This sets the option for an immediate output of the logs after the end of the program Switch the autoclave on with the power switch Select the SETUP Menu Function by short simultaneous pressing of the KEYs and The display shows Function Last batch number Navigate with the KEY or until on the display Function
55. n the menu Batch output No output medium see page 30 Initialization of the log printer Correct connection of the data cable to the autoclave and test at the output medium Ensure electric power supply the red LED P at the log printer MELAprint 42 must light red Set printer to online press key SEL at the MELAprinf 42 LED SEL must light green The message is shown at the start of a program Repeatedly press the KEY S to delete the message and the program starts The oldest log is then deleted Chapter 9 Errors MELAG Warning message Possible causes What you can do An output medium is registered and in the menu Batch output the option Immediate output No is set Set printer to Immediate output Yes see page 33 Automatic immediate log output Delete printer memory see Page 34 Delete stored logfiles possibly output all stored logs beforehand see page 34 Print all saved logs Log off the output medium in the menu batch output output medium and set the option no output medium Execute Service Test not successful Leakage rate 3 2 The servicing message is activated the device has reached the prescribed batch number The leakage rate determined by the vacuum test lies above the maximum permissible value of 1 3 mbar Door seal chamber flange is contaminated Door seal wrongly inserted The message is shown at program start Repeatedly press the KEY S t
56. nated flow method with pulsating repeated steam entry and outlet sucks the air out of the chamber and conducts saturated steam into the chamber Depending on selected program and the current chamber temperature at program start additional fractionations are connected The heating up phase follows after the evacuation phase The pressure and the temperature climb with continual steam introduction in the chamber until the sterilization parameters are reached After achieving the sterilization parameters of pressure and temperature the sterilization phase begins In alternation with pressure and temperature the remaining time of the sterilization phase is also displayed A pressure discharge with a corresponding display is carried out at the end of the sterilization phase The drying phase begins after the pressure discharge This runs in two stages the flow drying and the vacuum drying Chapter 4 Sterilization MELAG Program sta stop Current drying since 2 0 9bar 85 C 66 Vacuum drying 1 0 9bar 60 C 66 Eg A Danger of burning Manual termination before beginning of drying Program sta stop Stop program button Stop Ke Eg Manual termination during drying A program can be terminated during the flow drying as well as during the vacuum drying pulsating overpressure drying without resulting in an error message b
57. nding vertically at small intervals to each other m Do not place several soft sterilization packages flat on top of each other on a tray or in a container m Ifthe welding seam tears open during sterilization then it might be that the wrapping was too small If this is the case re wrap the instruments and sterilize them once again The packaging should be filled to or the spacing for the sealing seam at 3 cm m f the welding 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 endangering the health of the patient and practice team The autoclave functions on the fractionated pre vacuum method This permits the use of multiple wrapping For sterilizing mixed loads observe the following instructions Always place textiles on the top sterilization containers at the bottom unwrapped instruments at the bottom Transparently wrapped sterilization packages and paper packaging on the top exception in combination with textiles on the bottom The heaviest loads at the bottom Stack transparently wrapped sterilization packages if possible edgewise in such a way that alternately paper side lies on paper side and foil side on foil side if this is not possible then with the paper side facing downwards 21 Chapter 4 Sterilization 22 Loading variants
58. ng to DIN EN 13060 DIN EN 13060 Stainless steel cleaning agent e g Sidol Standards compliant Conformity with all the relevant standards Sterile barrier systems Closed minimum packaging which prevent the occurrence of microorganisms e g bags closed with sealing closed reusable containers folded sterilization cloths 55 Glossary 56 Sterilized items Also designated as batch if already successfully sterilized sterile goods Sterilization chamber Interior of a sterilizer Takes up the items to be sterilized 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 MELAG Appendix A Accessories Article Order number Euroklav 23 VS Euroklav 29 VS Tray mounts A for 5 trays or 3 standard tray cassette 40244 40233 B for 4 standard tray cassettes 40224 40234 D for 2 high cassettes or 4 trays 4
59. nt version of the software on the internet page of MELAG on www melag de in the download area Connect the MELAflash CF Card Writer with the serial interface like the log printer MELAprinf 42 see page 30 and set at the autoclave as output medium MELAf1lash in the SETUP Menu You will find detailed information in the operating manual for the MELAflash CF Card writer itself NOTICE Naturally you can also allow the MELAflash CF Card Writer to be connected permanently to the autoclave like the log printer MELAprinf 42 MELAnet Box as output medium The MELAnet Box enables the connection of the autoclave with a real ethernet interface to the computer network of the practice or clinic The logs which are created during a program run can be saved by means of a gt FTP server or over TCP via the MELAnet Box on the computer In the MELAnet Box there runs a small webserver program which displays status information of the connected autoclave and settings for the MELAnet Box via a webbrowser Thus you can allow the display of the current progress of a program cycle or current measured values Connect the MELAnet Box with the serial interface like the log printer MELAprinf 42 see page 30 and set at the autoclave as output medium MELAnet in the SETUP Menu Function You will find detailed information in the operating manual for the MELAnet Box itself Computer as output medium In order to be able to employ a computer as output
60. o delete the message and the program starts Retain the message press the S key twice to start Carry out maintenance with MELAG customer service or service of the specialist trade NOTICE Service counter is reset by the customer service Check door seal and chamber flange for cleanliness possibly clean Check door seal for damage possibly exchange see page 11 Repeat vacuum test with completely cold device Check door seal for correct seating Repeat vacuum test with completely cold device Warning Battery empty The monitoring of the device s internal battery voltage has determined a too low voltage value The battery must be exchanged by MELAG customer service or service of the specialist trade 49 MELAG Error message Possible causes What you can do Error 1 Vacuum system Door seal sealing surface at Check door seal and sealing surface at the the chamber is polluted or chamber for contamination and clean it defective Check door seal for defects possibly exchange see page 11 Door seal wrongly inserted Check door seal for correct seating Check the correct set up of the autoclave Check the autoclave for fallen instruments filter paper etc which might be lying on the chamber floor Error 2 Steam generator autoclave is overloaded Pay attention to the correct loading quantities see page 20 Load autoclave Decreased heating power since Check building side electrica
61. of the sterilizing materials according to the manufacturer s instructions Furthermore the materials cleaning agents and processing procedure employed are of significance NOTICE If possible sterilize textiles and instruments separately from each other in separate sterilization containers or sterilization packages This way you achieve improved drying results 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 Adjust the folds of the textiles parallel to each other Stack the textiles in the sterilization containers vertically if possible and not too closely together so that flow 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 textiles can be obstructed and or bad drying results can result Unsterile textiles could be the consequence This could mean endangering the health of the patient and the practice team 19 Chapter 4 Sterilization 20 Instrument
62. ogram selection button P Select the sterilization program according to how the items to be sterilized are wrapped Furthermore consider the resistance to high temperature of the items to be sterilized The following table shows which program to use for which items to be sterilized Chapter 4 Sterilization MELAG Programs Wrapping Especially Sterilization Operating Drying Load Suitable for at time 23 VS 29 VS Universal single and mixed loads Program multiple long simple hollow 134 C 25 min 25 min 4 3 kg wrapping bodies Quick only simple solid Program S unwrapped instruments no textiles transmission 134 C 15 min 10 min 4 3 kg instruments simple hollow bodies Gentle single and textiles Textiles Program Faea thermo instable goods 1 0 8 kg e g plastic rubber 121 C 40 min 25 min Thermo instable articles Goods Mixed loads 4 3 kg Prion Program single and instruments where a multiple danger of infection by wrapping pathologically modified 134 C 40 min 20 min 4 3 kg proteins is suspected e g Creutzfeld Jacob BSE without drying full load in the Euroklav 23 VS 4 kg and Euroklav 29 VS 3 kg and depending on the load and installation conditions such as supply voltage Function autom preheating Select automatic pre heating With the automatic pre heating the chamber of the autoclave
63. ogram with a corresponding notice If the program was successfully concluded an appropriate message is issued on the display Manual function test You can track the program sequence based on the values shown on the display Furthermore on the basis of logs made for every program you can logically reconstruct whether a program was successful see page29 Chapter 5 Logging 43 Chapter 8 Function test Testing in daily operation Vacuum test Weekly in routine operation Conduct a vacuum test in the following situations at initial start up after Once weekly in routine operations pauses longer than two Atinitial start up weeks and in case of error After longer operating pauses In case 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 Switch the device on at the mains switch The display switches into its initial state Vacuumtest 6 Press the Key P until the menu Vacuumtest is shown in the display Close the door This is confirmed with the appropriate display Door closed Press the KEY S in order to start the vacuum test 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 chamb
64. ompliance with the standards dust protected storage is assumed this time period is up to six months MELAG 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 How to read the logs correctly How to set the date and time at the autoclave Batch documentation The batch documentation is indispensable as documentation for the successfully completed sterilization process and as an obligatory measure of quality assurance Medical Devices Operator Ordinance The data such as type of program as well as batch and process parameters of the 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 Capacity of the internal The capacity of the internal storage suffices for about 40 logs log memory If the internal log memory is full when starting the next program the respectively oldest report is automatically overwritten If you have connected a printer and additionally the option immediate output is set to No see also Page 33 Automatic immediate log output a confirmation prompt appears before the saved record is overwritten For additional information
65. on connecting the printer see page 30 Connect printer Output media You can store the logs of the completed programs on the following output media and archive them accordingly Log printer MELAprint 42 MELAflash CF Card Writer on CF card Computer e g with software MELAwin MELA view MELAnet Box Modem State on initial delivery No option for the output of the logs is set in the initial delivery state of the autoclave You can read below how to output the logs on the cited media 29 Chapter 5 Logging 30 Observe time re settings Function Date Time 66 Data connection from the autoclave Si Connect printer 1 2 Set 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 Set date and time as described below Select the SETUP Menu Function by short simultaneous pressing of the KEYS and The display shows Function Last batch number Navigate with the Key or in the Menu Function up to the display Function date time are displayed Press the Key P in order to confirm The current hour is displayed Select between the following setting possibilities with the KEY or Hour minute second Day month year n order to adjust the hour p
66. on of the instrument is carried out An appropriate display is shown on the screen After the pressure discharge or ventilation is carried out there is a request for an acknowledgement of the program termination The message Unlocking door with button is displayed in alternation with the previously selected program After pressing the KEY you can open the door A reference to Program stopped load not sterile is issued to the logging printout In the drying phase you can cancel the program with the KEY S You must then expect insufficient drying especially for wrapped sterilized items Sufficient drying is a prerequisite for sterile storage 25 Chapter 4 Sterilization 26 Immediate removal Press STOP Xe Eg Last batch number 7 Quit with button 66 Sterilization phase successfully finished Sterilization still2 min 12sec 56 Sterilization not successfully finished Program abort by the system Improve drying results Therefore if possible always let sterilization programs with wrapped items continue up to the end of the drying phase In a Quick program sterilized unwrapped instruments dry from their own heat after removal from the autoclave In the drying phase the expired drying time is shown in alternation with the message Immed Removal Press Stop is displayed To terminate the program carry out the following
67. ons m Two people are necessary to carry the autoclave Use a suitable carrying strap to transport the autoclave m f repeated error messages occur while operating the autoclave turn the device off and notify your specialist dealer m Only have the autoclave repaired by authorized persons MELAG Contents Chapter 1 Performance Specification 6 PrOPGPr USC ici shied ig E E E 6 User b nefit cir ceca csateeles beet a eeeasii asses 6 Overview of sterilization programs 8 Chapter 2 Device Description scsseee 9 Scope Of delivery ceesceceseeeeeedeceeseeetdeedensteeteeeetees 9 Device VICWS vic siieccessecceehssietargceeebent eenctenannieees 10 Effective capa ity sisii 11 Mountings for the load neee 11 Control panel siiairc iini 12 Supply with feed water eeen 12 Chapter 3 Initial start up ceesseeeeeeeeeee 14 Conditions for setting up installing and starting up AEE A AA E E Siete 14 Set up location requirements 14 Connections required eneee 15 Prerequisites for initial start up eee 17 Record of installation and setting up 17 Switch on autoclave 17 Chapter 4 SteriliZation cseccseeeeseeeeeeeeeees 18 Create prerequisites 0 eee eeeeeeeeereeeenneeeeeenes 18 Select feed water Supply scere 18 Prepare items to be sterilized 0 eee 19 Load the autoclave ncen 20 Close the dO isiin iredi iiid 22 Select PLOGraM ns seicessegecacetescocebars
68. 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 to help you keep the serial number of your autoclave and a detailed fault description of the fault report ready Warning message Possible causes What you can do Warning Door open No start possible Door switch is not closed on start Push the sliding closure grip downwards until the stop Correct display Door closed Warning No feed water Refill feed water No start possible Only if feed water supply from internal storage tank not enough feed water in the internal storage tank Check feed water level in the internal storage tank check if necessary refill feed water Warning No feed water Check feed water quality The warning message appears after program start The built in flow monitor doesn t close Feed water supply from internal storage tank If the message appears repeatedly have the unit checked by the MELAG customer service Feed water supply from MELAdem 40 Check water treatment unit possibly open inflow to the unit If the message appears repeatedly have the unit checked by the MEL
69. 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 Re startup after change of locality At re startup of the autoclave after a change of locality proceed as for an initial start up see page 14 Chapter 3 Initial start up MELAG 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 How you display the water quality Automatic function test Process evaluation and The interaction of the sterilization relevant parameters of pressure monitoring system 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 pr
70. rforations 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 endangering the health of the patient and the practice team The sterilization containers from MELAG satisfy all requirements according to DIN EN 868 for successful sterilization and drying They are perforated in the lid and floor and are equipped with disposable paper filters Stack on top of each other if possible only sterilization containers of the same size and with respectively identical spacer feet where the condensate can run off on the side at the walls 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 endangering the health of the patient and the practice team Soft sterilization packages can be sterilized both in sterilization containers on trays or standing when using a package holder When using soft sterilization packages such as MELAfol observe the following instructions m Arrange the soft sterilization packages sta
71. s A Danger of infection Wrapping A Warning Closed sterilization containers 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 of your country m Clean the instruments very thoroughly for instance with the help of a thermal disinfector m After disinfection and cleaning rinse the instruments if possible 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 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 Ultrasonic units Maintenance appliances for hand pieces and angle pieces Cl
72. seceheusHeeneceen weiss 22 Select automatic pre heating ee eeeeeeeees 23 Select additional drying ee eeeeeeeeeeeteeeeeees 24 Start program iiidid 24 Program iS UNNIN eceeeeeeeeeeeeeneeeeeeeneeeeeeeeees 24 Manually terminate program enee 25 Sterilization phase is finished eee 26 Drying pha S ien iiid 26 Program is finished 27 Display batch NUM Er seeeeeneennn 27 Remove sterilized items oe eeeeeeeeeteeeeeeeeeees 27 Storage of sterilized items eee eeeteeeerees 28 Chapter 5 LOQGING csseceseeseeeseeeeeeeeeeeeeeee 29 Batch documentation ccceeeeeeseeeeeeenneeeeeeeees 29 Set date and time aeee 30 Use printer as output medium 30 Employing MELAflash as output medium 32 MELAnet Box as output medium eee 32 Computer as output medium eee 32 Automatic immediate log output eee 33 Output the logs subsequently 0 0 eeeeeeeeeees 33 Display protocol MEMOTY esenee 35 Read log files Correctly 0 0 eeceeeeeeeeeeesseeeeeeeeeees 35 Chapter 6 Maintenance ccseeeeseeteees 37 CIC AMING oies rinna aas iini aaia 37 Avoid formation of Spots eeee 38 Use qualitatively high grade feed water 39 Exchange the door seal 39 Maintenance wis cicesgecacecagpbeesssnctevesbeptuennctesievutieees 39 Chapter 7 Operating pauSes ssseeeeeeee 41 Sterilization frequency seee 41 Pause times a iaae e T 41 SH
73. splay shows Function Last batch number Press the KEY P to display the current batch number of the day In order to reach the starting position again press the KEY S twice You can allow the display of the number of total batches Select the SETUP Menu Function by short simultaneous pressing of the KEYs and The display shows Function Last batch number Navigate with the KEY or up to the display where the submenu Batch counter is shown Press the Key P You see the current counter reading of the total batch number on the display n order to reach the starting position again press the KEY S twice Remove sterilized items After the end of a program observe the following instructions for removing the sterilized items m Never open the door by force The autoclave could be damaged and or hot steam could escape m Use a tray lifter to remove the tray m 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 m Check the wrapping of the sterilized objects for damage when removing them from the autoclave m lf 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 After the end of a program the request Quit with button is displaye
74. splayed Navigate with the Key or until the display Last cycle output No 40 is shown as example No 40 Press the Key P The current report number blinks 33 Chapter 5 Logging 34 Print all saved logs Output stored cycles S 6 Delete stored logs All cycles Delete 66 n order to output a log of another cycle navigate with the KEYS or up to the desired number here e g 25 Press the Key P in order to start the output of the selected program The display shows Output After finished printout the display changes again to its previous setting Last cycle output No 25 In order to output additional logs repeat the last three steps In order to leave the submenu without outputting press the Key S n order to leave the menu after the output press the Key S The display shows the menu Function Batch output By again pressing the KEY S you completely leave the menu and return back to the basic position of the display In order to subsequently output all saved logs proceed as follows Select the SETUP Menu Function by short simultaneous pressing of the keys or The display shows Function Last batch number Navigate with the KEY or until on the display Function Batch output is shown and press the KEY P Navigate with the Key or until the display Output stored cycles is displayed Press
75. ter of the respective quality see page 39 Use qualitatively high grade feed water You can use the removable funnel insert to conveniently fill fresh feed water into the right chamber of the storage tank up to the MAX mark Simply remove the filter for cleaning f you employ a water treatment system 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 Switching on Ifthe autoclave is still not switched on switch it at the mains switch page 10 Fig 1 4 See as of page 17 Switch on autoclave Select feed water supply Switch between internal and Depending on whether the feed water should be supplied from the internal external feed water supply storage tank or whether you employ a water treatment unit for the feed water supply select the appropriate setting on the display Feed water supply S SX Select the setup menu by simultaneous brief pressing of the Keys intern and The display shows Function Last batch number Navigate with the Key or up to the display Function Feed water supply Press the Key P The currently set option appears on the display e g Feed water supply intern To set the value to Feed water supply extern press the KEY P again Chapter 4 Sterilization MELAG Choose the one way fee
76. the autoclave Conditions for setting up installing and starting up m Only have the autoclave set up installed and started up by people authorized by MELAG s m According to the currently valid VDE standards this device is not f l suitable for use in areas subject to explosion hazards Danger 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 metres Damages to the autoclave and or injuries can occur in case this precaution is not observed Set up location requirements Location 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 A m Without fail keep the specified distance free to the surrounding surfaces at the sides and above the autoclave Warning Non observance can lead to heat accumulation This could adversely affect the function of the autoclave and entail the shortening of the vacuum pump s service life and result in extended program times Distance to the surrounding The distance to the surrounding surfaces must be at least 10 centimetres surfaces on both sides and 10 centimetres at the back side The autoclave should be freely accessible from above so that the built in storage tank can be filled and a good ventilation is guaranteed 14 Chapter 3 Initial start up MELAG
77. tion frequency Pause times between the individual programs are not necessary After the expiration or termination of drying and removal of the items to be sterilized you can immediately re load the autoclave and start a program Continuous operation can result in an increased development of steam from the internal storage tank The steam is not harmful to the autoclave provided that the minimum clearance distances of the autoclave were maintained on site at installation To minimise the development of steam we recommend that you maintain a pause of 20 min between every two batches Pause times Switch the autoclave off for longer operating pauses e g overnight or on the weekend and leave the door ajar The door seal is relieved and protected from premature wear Furthermore it prevents the sticking of the door seal Close if available the water feed of the water treatment unit After operating pauses which last longer than two weeks carry out a vacuum test and thereafter an empty sterilization with the Quick Program see page 43 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 Door cannot be opened Door seal is sticking to the Switch the autoclave on and pull vigorously at sealing surface the door to open it Func
78. tion test after pauses After pauses carry out the tests described in Chapter 8 Functional Tests depending on the pause duration 41 Chapter 7 Operating pauses 42 A Danger of injury A Warning Shut down If you would like to shut down 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 Empty both chambers of the storage tank Close if available the water feed of the water treatment unit Transport 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 Observe that the spacing between the underside of the housing floor plate of the autoclave and the footprint is small In case of non observance spine damage and contusions can result Observe the following when transporting the autoclave e g when moving or shipping the autoclave or for the transport within the practice m Empty both chambers of the storage tank When using a water treatment unit close the water feed and removal the hose connections at the rear of the device m Ifyou would like to leave the mounting and the trays or cassettes in the chamber during transport protect the surface of the door plate Lay a piece of foam plastic
79. tions are displayed 35 Chapter 5 Logging 36 Program Universal program 134 C wrapped Date 18 10 2007 Time 08 46 39 Start Batch No 5 Pre heating 96 8 C Conductivity 7 pS cm Start 0 01 29 1 00 00 Pre vacuum Evacuation Oe 25 C9 ed OILS ST Steam entry 0 01 834 62 03215 1 Fractionation Steam entry Ln Oe 113 8 04 40 Press release 0 18 102 1 05 04 2 Fractionation Steam entry 1 01 117 9 06 03 Press release 0 19 03 6 06 33 3 Fractionation Steam entry 1 01 LISST O74 29 Press release 0549 105 2 08 03 4 Fractionation Steam entry 1 01 202 09 201 Press release 0 19 105 6 09238 5 Fractionation Steam entry 1 01 120 0 10 34 Press release 0 19 OSG 11413 Heat up 2 04 L34 1 13 22 Steriliz begin 2 04 134 1 13 22 Steriliz end Leld L305 S2 Press release 0 49 116 2 1923 Current drying Drying begin 0 49 L16 2 19323 Drying current 0 39 108 8 19 42 Drying pumping 1 21 110 4 20 22 Vacuum drying Drying begin 1 20 103 7 34 04 Drying sub atm 0 51 96 4 35 14 Drying pumping 0 61 LO 3612 Drying end 0 60 102 5 43 52 End 0 02 00 4 44 14 Program properly executed Temperature 135 8 0 6 0 6 C Pressure 2 19 0 06 0 05 bar Sterilizate time 5 min 30 s Time of day 09 30 53 End 7 200703054 4 06 4 06 CRC 0x1EB3 V1 30A Header Started program Current date time at program start daily batch number Preheating temperature conductivity of the feed water Valu
80. toclave off before cleaning and pull the power plug from the wall socket Make sure that the chamber is not hot Use a soft and lint free cloth Use chlorine and vinegar free cleaning agents First drench the cloth with cleaning alcohol or methylated alcohol and try to wipe off the contamination m Incase of 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 to clean the door seal m 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 not tight 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 37 Chapter 6 Maintenance 38 A Warning Operation with feed water circulatory system Formation of spots due to improperly cleaned instruments Formation of spots due to third party rust Formation of spots due to inadequate quality of t
81. too high What you can do if there are bad drying results A Danger of infection A warning is not an error Not all messages which appear on the display are error messages Warning messages Warning messages are displayed when necessary 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 message Error messages are displayed if safe operation or sterilization security is not guaranteed These can appear on the display shortly after switching on the autoclave or while a program is running The program is aborted if a malfunction occurs during a program run m lf a program is aborted during the sterilization phase the load is unsterile Repackage and repeat the sterilization for the respective items to be sterilized Non observance endangers the health of your patients and the practice team The error message is then shown on the display in alternation with the current program phase Pressure release Ventilation or End After the program abort or termination the error message is shown on the display in alternation with the message Acknowledge with button and Program stopped In order to delete the error message press the KEY Chapter 9 Errors MELAG Before you call Follow the operating procedures shown in connection with a warning text
82. ure grip Mains switch Front foot of the unit adjustable Serial data and printer connection RS232 Device safeguards 2x 16A gRI Reset button for overheating protection Connection for emptying the storage tank feed water Connection for emptying the storage tank waste water hidden behind the white cover Tank cap Safety valve Sterile filter One way drain Purified feed water inlet via internal storage tank Hose bridge for internal feed water supply Power cable Chapter 2 Device Description MELAG Interior view 1 Chamber 2 Mounting to hold trays cassettes Fig 2 Interior view Effective capacity Euroklav 23 VS 45 cm 22 litres Mountings for the load The autoclave is always delivered with a mounting to hold trays or cassettes The mounting A is standard and can hold either five trays or three standard tray cassettes rotated by 90 Fig 3 Mounting A 1 The mounting B can hold four standard tray cassettes or four trays Fig 4 Mounting B The mounting D can hold two high cassettes e g for implant cassettes or four trays rotated by 90 BeA Fig 5 Mounting D 11 Chapter 2 Device Description 12 Control panel The control panel consists of a two line alphanumerical LED display and four membrane keys 2 line LED display for program status display and chamber pressure bar and Time h min s parameter disp

- Frank`s Hospital Workshop

Contents

Download Pdf Manuals

Related Search

Related Contents