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MELAG MELAtronic 15 EN+, Руководство пользователя

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Dear doctor, 
 
We thank you for your confidence demonstrated by the purchase of this MELAG product. 
 
As an owner-run and operated family concern founded in 1951, we have a long history of successful 
specialization in hygiene products for practice-based use. Our focus on innovation, quality and the highest 
standards of operational reliability has established MELAG as the world’s leading manufacturer in the instrument 
treatment and hygiene field. 
 
You, our customer are justified in your demand for the best products, quality and reliability. Providing 
"competence in hygiene" and "Quality – made in Germany", we guarantee that these demands will be met. Our 
certified quality  
management system is subject to close monitoring: one instrument to this end is our annual multi-day audit 
conducted in accordance with ISO 13485. This guarantees that all MELAG products are manufactured and tested 
in accordance with strict quality criteria. 
 
The MELAG management and team

 

 

User Manual 

Autoclave 

MELAtronic

® 

15 EN+ 

as of software version 5.15 

 

 

 

 

 

Содержание MELAtronic 15 EN+

Страница 1: ...trument treatment and hygiene field You our customer are justified in your demand for the best products quality and reliability Providing competence in hygiene and Quality made in Germany we guarantee that these demands will be met Our certified quality management system is subject to close monitoring one instrument to this end is our annual multi day audit conducted in accordance with ISO 13485 T...

Страница 2: ...hese operating instructions carefully and in close proximity to your autoclave It represents a component of the product MELAtronic 15 EN as of software version 5 15 Responsible for the contens MELAG Medizintechnik oHG Geneststraße 6 10 10829 Berlin Germany E Mail info melag de www melag com Dokument BA_15EN _10615_EN_v7 docx Revision 7 18 1847 Date of update 2018 09 11 Subject to technical changes...

Страница 3: ...e practice fittings or the autoclave Important information Draws your attention to important information Accentuation of an example Meaning Explanation Conductivity measurement Glossary entry Words or phrases marked with an arrow are explained in the glossary The glossary is listed alphabetically It can be found at the end of this manual Universal Program Software citation Words or phrases appeari...

Страница 4: ...ired packaging materials at the collection points of the dual system Symbols on the steam sterilizer In affixing this CE mark the manufacturer declares that this medical product fulfils the basic requirements of the medical device directive The four digit number confirms that this is monitored by an approved certification agency In affixing the CE mark the manufacturer declares that this medical p...

Страница 5: ...afety information Failure to comply of the safety instructions could result in human and material damage The symbol of the struck out waste bin identifies a device that may not be disposed in the domestic waste The vendor is responsible for appropriate disposal of the device it must be delivered to the vendor to be disposed of With the designation of an apparatus with this symbol the manufacturer ...

Страница 6: ...zation of textiles and instruments e g from the RKI and DGSV Only ever use packaging material and systems which have been cleared by their manufacturer for steam sterilization consult the manufacturer s instructions Program abort Please observe that depending on the time of the program abort opening the door following a program abort can lead to hot steam leaving the chamber Depending on the time ...

Страница 7: ... is finished 26 Drying phase 26 Program is finished 27 Displaying the batch number 27 Removing the sterilized equipment 28 Storing sterile instruments 28 Chapter 5 Logging 29 Batch documentation 29 Setting the date and time 29 Use printer as output medium 30 Use MELAflash as output medium 31 Use MELAnet Box as output medium 31 Use the computer as output medium 31 Automatic immediate log output 31 ...

Страница 8: ... the technical documentation and only in connection with the devices and components as cleared for use by MELAG As with the preceding instrument treatment the sterilization of instruments and textiles using this autoclave may only be carried out by competent personnel When conducting sterilization procedures only use instruments packaging and textiles which the manufacturer has cleared for steam s...

Страница 9: ...ting time of a program in dependence on the load High safety via comprehensive safety features The autoclave constantly checks pressure and temperature in the chamber The door locking system prevents the door from being opened when excess pressure has been built up The autoclave electronics has an integrated process evaluation system It compares the process parameters such as temperature time and ...

Страница 10: ...IN EN 13060 Type S Type S Type S Type S Dynamic pressure test of the sterilization chamber X X X X Empty chamber test X X X X Massive load unwrapped X X X X Massive load single wrapped X X X Porous load single wrapped X X X simple hollow items Hollow body B X X X X Drying massive load X X X X Drying porous load X X X X Complies with all applicable sections of the standard DIN EN 13060 ...

Страница 11: ... by the autoclave Scope of delivery Standard scope of delivery MELAtronic 15 EN User Manual Record of installation and setting up Declaration of conformity Pressure Device Directive certificate Guarantee certificate Manufacturer s inspection report 1 Mounting for trays 1 tray lifter 1 hose for emptying the interior water storage tank TORX spanner for removing the carrying strap 1 chamber filter ke...

Страница 12: ...e foot rear 10 Mains cable 11 Fuses 2x 16A gRL 12 Connection to external condensate container 13 Serial data and printer connection RS232 14 Ventilation hose from storage tank View from above open 17 16 23 21 22 18 19 20 15 15 Internal storage tank 16 Spring safety valve 17 MAX mark 18 Float switch feed water 19 Discharge outlet leads to drain valve 20 Water intake filter 21 Quick coupling for con...

Страница 13: ...cartridges The mounting is standard and can accommodate three trays Figure 1 Tray mount Operating panel The operating panel consists of a two line alphanumerical LED display and four membrane keys Function keys and to select set and display special functions print date time pre heating total batches conductivity acknowledge error KEY for unlocking door Program selection key P to select the sterili...

Страница 14: ...r distilled feed water in accordance with DIN EN 1360 to generate steam The supply with feed water is effected from the internal storage tank The autoclave draws in the feed water automatically Feed water via the internal storage tank When using the internal storage tank for the feed water supply it is necessary to refill it periodically The autoclave will issue a maintenance message at the releva...

Страница 15: ... carrying straps Unscrew the four screws from each side of the housing to remove the blue carrying straps Re screw these screws without the washers Store the carrying straps and washers in a safe place Requirements of the installation location Location Install the autoclave in a dry and dust protected location Humidity should amount to between 30 60 and the surrounding temperature 16 26 C Horizont...

Страница 16: ...mains socket must be freely accessible after installation so that the device can be taken from the electricity supply at any time Provide the following electrical connection for the autoclave A 220 240V circuit max voltage range 207 253V and 50 60 Hz 16 A separate fuse a minimum of the automatic type B FI protection 30 mA Connected rating 1500 W Observe the following safety measures when dealing w...

Страница 17: ...p to its fullest extent Remove the evaporator coil from the storage tank by pressing the quick coupling Fig 1 21 on the pressure release backwards Retain the evaporator coil in case you need to return it NOTE The water from the external condensate container may not be used for further sterilization The condensate container must be fitted underneath the autoclave The outlet hose must be fitted with...

Страница 18: ...the autoclave Switch on at the mains Switch on the autoclave at the mains Fig 1 2 After switching on After the autoclave has been switched on at the mains the display will alternate between the basic state and the message Unlocking door with key If the door is locked The trays and accessories must be removed from the chamber directly after the autoclave having been switched on for the first time a...

Страница 19: ...eed water up to the MAX mark in the storage tank NOTE Ensure that the water level does not rise above the MAX mark Notice In order to allow the off flowing steam to condense entirely to prevent an undesirable steam ejection from the storage tank and to avoid increased feed water consumption the evaporation coil in the storage tank should always be covered with feed water The storage tank should al...

Страница 20: ...ow both the instrument manufacturer s instructions regarding treatment and sterilization and comply with the relevant standards and directives e g from the BGV A1 RKI and DGSV Clean the instruments exceptionally thoroughly e g using a washer disinfector Rinse the instruments after washing and disinfecting where possible with de mineralized or distilled water and then dry the instruments with a cle...

Страница 21: ... the bottom Failure to observe these points results in insufficient steam penetration and a possibly unsuccessful sterilization result It also prevents the drain off of condensate and produces poor drying results This can result in unsterile instruments and thus endanger the health of patient and practice team MELAG sterilization containers fulfil the requirements of DIN EN 868 for successful ster...

Страница 22: ...ld be loaded on top with the single exception When loaded in combination with textiles they should be loaded at the bottom Transparent sterilization packaging should be loaded on their edges so that the paper side and film side are in contact If this is not possible the paper side should face downwards Loading variations MELAtronic 15 EN Instruments Textiles Max no per single piece 2 kg 150 g Load...

Страница 23: ...able for Load Universal Program unwrapped and single wrapped Mixed loads long simple hollow items hollow body B 2kg Quick Program S only unwrapped no textiles Simple massive instruments 2kg Gentle Program unwrapped and single wrapped Textiles thermo unstable items e g plastic rubber simple hollow items hollow body B massive instruments Textiles 150 g Thermo unstable items 2 kg Prion Program unwrap...

Страница 24: ...he display will show both the selected program and sterilization temperature as well as whether the program is suitable for wrapped or unwrapped sterilization material Press the S key to start the program The autoclave checks the feed water supply and its conductivity If the Quick Program S has been started the warning Attention only unwrapped instruments appears on the display If the load contain...

Страница 25: ...m abort opening the door following a program abort can lead to hot steam leaving the chamber Use a tray lifter to remove the tray Never touch the sterilized equipment the chamber or the door with bare hands The components are hot When removing the tray cassettes always use either a tray lifter or gloves The components are hot Failure to observe this requirement can result in burns Manual abortion ...

Страница 26: ...ber with the corresponding display text the message Universal Program run successfully is displayed in alternation with Last batch number xx and Quit with key If a printer or other output media is connected to the autoclave and the option Immediate ioutput is set to Yes the warning Drying stopped is issued on the log Sterilization phase is finished Sterilization phase successfully ended The displa...

Страница 27: ...play after every program run You can also arrange for the batch number to be displayed To do so Press the und keys simultaneously to select the setup menu Function The display shows Function last batch number Press the P key to display the current daily batch number To return to the basic state press the S key twice Displaying the total batch counter You can arrange the display of the number of th...

Страница 28: ...bserve the following regarding the door The door plate in particular can be hot during and after a program run Never touch the door plate directly Touch only the twist grip to open the door Failure to observe these requirements can result in burns Residual condensate on the sterilized equipment If you remove the sterilized equipment from the autoclave directly after the end of the program it is po...

Страница 29: ...mediate log output a safety question will be displayed before the log is overwritten For further information see page 30 connecting a printer Output media You are able to issue and archive the logs of the completed programs on the following output media MELAprint 42 44 log printer MELAflash CF card printer on a CF Card Computer with the software MELAtrace MELAview MELAnet Box From device version 5...

Страница 30: ...itch it on Wait until the display shows the basic position page 13 Operating panel Select the setup menu Function by pressing the and keys quickly and simultaneously The display shows Function last batch number Navigate in the Function menu using the or keys until the display shows Function log output Press the P key to select the sub menu Log output output medium Press the P key again The display...

Страница 31: ...an Ethernet interface The logs generated by an autoclave during the programme run can be saved via the MELAnet Box using an FTP server The MELAnet Box also supports a small web server program which displays the status information of the autoclave connected and the settings of the MELAnet Box via a web browser You can use it to display the current progress of a program run or current measurement va...

Страница 32: ...warning will appear MELAG recommends using the immediate log issue function Subsequent log issue It is possible to issue logs subsequently and independently of the time of the end of the program You can choose whether all or only the saved logs up to 40 are to be printed Use the output media connected for this task e g the log printer Printing selected logs To print the subsequently selected logs ...

Страница 33: ...ly to the printer Press the S key to leave the menu The display shows the setup menu Function Log output Repeated pressing of the S key enables you to leave the menu entirely and return to the display basic state Deleting the saved logs Delete the saved logs manually to suppress warning messages e g Log memory full with the option Immediate output set The following example shows how to delete all ...

Страница 34: ...isplay shows Function last batch number Navigate using the or keys until the display shows Function log output and then press the P key Navigate using the or keys until the display shows the number of logs saved see image of display Press the S key twice to leave the menu Reading logs correctly Head The head of the program log comprises the general basic information regarding the program run This ...

Страница 35: ...49 3 Fractionation Steam entry 1 00 120 1 06 24 Pressure release 0 20 106 0 06 55 4 Fractionation Steam entry 1 01 120 5 08 33 Pressure release 0 19 105 7 09 10 5 Fractionation Steam entry 1 00 120 5 10 50 Pressure release 0 19 105 8 11 29 Heat up 2 05 134 2 15 04 Steriliz Begin 2 05 134 2 15 04 Steriliz End 2 19 136 1 20 34 Pressure release 0 14 107 0 21 32 Flow drying Drying begin 0 14 107 0 21 ...

Страница 36: ... impurities with this method Only if the chamber mounting or chamber seal face has persistent soiling should you use a mild stainless steel cleaning medium with a pH value between 5 and 8 To clean the door seal use a neutral liquid cleaning agent You should not allow cleaning agent to enter the piping coming from the autoclave chamber Do not use any hard objects such as metal saucepan cleaner or a...

Страница 37: ...ould be replaced Conductivity sensor Clean the conductivity sensor in the storage tank using alcohol and then clean the storage tank with water Refill with fresh feed water Cleaning the feed water pressure release filter in the chamber When operating with a feed water circulation system clean the chamber filter every three months Operation with a one way system requires cleaning every half year In...

Страница 38: ...ring the sterilization material Stain development from extraneous rust All steam conducting parts of the autoclave consist of non rusting material This rules out the possibility of stain or rust development being caused by the autoclave The development of rust is always extraneous rust Incorrect instrument treatment can result in the accretion of rust even on stainless steel instruments of leading...

Страница 39: ...ain the specified servicing intervals Continuing operation despite maintenance messages can result in malfunctions in the autoclave Value retention and operability Regular maintenance is vital to ensure reliable operation and value retention of the autoclave All function and safety relevant components and electrical units are checked during maintenance and replaced where necessary Maintenance is p...

Страница 40: ...ject to warming The excess steam then escapes via the ventilation hose on the rear of the autoclave To minimize steam generation we recommend holding a longer pause between two batches Pause times Longer operating pauses When making longer operating pauses e g over night or a weekend you should switch off the autoclave and only push the door to This relieves pressure on the door seal and protects ...

Страница 41: ... in injury to the spine and or pinching Notice Please observe the following during transport e g in the course of moving or despatch or for transport within the practice Empty the internal storage tank and remove the outlet hose to the external condensate container if you have used it If the danger of frost is given empty the feed pump in accordance with the service instructions only by a service ...

Страница 42: ...s or error messages If necessary it interrupts the program with appropriate information When the program has ended successfully the corresponding message will be issued on the display Manual functional checks You can follow the program run on the display via the values displayed there You can also use the logs recorded for every program to determine the success of a program see page 29 Chapter 5 L...

Страница 43: ...f the working day whilst the device is still cold To do so hold the key depressed until the display shows the conductivity The conductivity is displayed in µS cm As soon as you have released the key the display returns to its previous state e g basic state Pre heating temperature of the chamber After having pressed the key shortly twice hold depressed the second time Instead of displaying the cond...

Страница 44: ...nd after the program start during a program run If a malfunction emerges during a program run the program is aborted and pressure will be let off automatically Danger of infection Aborting a program before the drying phase means that the load is unsterile If necessary repack the load and repeat the sterilization for the sterilization material affected Failure to observe these provisions can endang...

Страница 45: ...gh Start no longer possible See warning message Poor quality of feed water Warning Replace sterile filter The sterile filter is soiled or torn Min Max pressure upon air drying is exceeded undercut Change the sterile filter MELAG Art No 20160 NOTE The message comes at the end of the program and in the last line of the log print out Output medium is not ready The autoclave is operating without an ou...

Страница 46: ...essage has been activated and the device has reached the pre set number of charges The message is displayed upon every program start Repeated pressing of the S key removes the message and the program starts Retain the message Press the S key twice Arrange for maintenance to be performed by the MELAG customer services your specialist stockist customer services NOTE The maintenance counter is to be ...

Страница 47: ...ckist Error 9 Door open The door twist grip was not closed tightly enough before the program start The door contact has opened during a program Screw the twist grip tightly shut Correct display message Door locked Upon repeated occurrence inform your stockist Error 10 Overheated Steam generator The capillary tube regulator level control is open during program start error message directly after the...

Страница 48: ...ilization TU1 Minimum permissible sterilization temperature has been undercut temperature sensor 1 Operate autoclave with smaller load Control the door seal for wear change if necessary Upon repeated occurrence inform your stockist Error 35 Sterilization TO1 Maximum permissible sterilization temperature has been exceeded temperature sensor 1 Upon repeated occurrence inform your stockist Error 36 S...

Страница 49: ...cian or MELAG customer services NOTE To avoid leaks always screw the door tight before starting a program independently of the display message door closed Too high feed water consumption Operation in a circulation system If you do not have an external condensate container i e the autoclave is being operated in circulation system incomplete condensation leads to increased water consumption A possib...

Страница 50: ...ber floor Ensure that the autoclave is loaded correctly see page 20 Loading the autoclave The chamber filter is blocked Check and clean this where necessary Do not overload the autoclave Please ensure that there are no textiles in direct contact with the chamber wall and floor Activate the pre heating function see p Selecting automatic pre heating ...

Страница 51: ...o 80 at 31 C decreasing in a linear fashion up to a relative humidity of 50 at 40 C Installation category II Feed water quality Demineralized water in accordance with DIN EN 1360 Appendix C Max load Instruments 2 kg unwrapped instruments 1 kg single wrapped instruments Textiles 150 g unwrapped and wrapped textiles Energy consumption during a program Universal Program 250 Wh Quick Program S 200 Wh ...

Страница 52: ... without them boiling This represents an unstable state even low level agitation can produce a large bubble within Demineralized water also called aqua dem water without the minerals usually found in normal spring or tap water is produced though ion exchange of normal tap water Used here as feed water Distilled Water from the Latin aqua destillata also referred to as aqua dest water which to a gre...

Страница 53: ...apped in film and placed in an additional container or a container wrapped in textiles Porous permeable for fluids and air e g textiles Porous small components made of materials which are able to absorb fluids Porous full load test of porous full load serves to prove that with the values set in the control the necessary sterilization conditions are reached within an entire load filled with the max...

Страница 54: ...Glossary 54 VDE Verband der Elektrotechnik Elektronik und Informationstechnik e V Alliance of the Electronics Electrotechnical and IT Industry ...

Страница 55: ... 12 x 35 cm 00150 For the documentation MELAflash CF card printer with CF card and card reader 01039 MELAprint 44 log printer 01044 MELAnet Box 40296 Other External condensate container 00356 MELAjet Sprühpistole 27300 Spare parts Device fuses 16A gRL 57592 Sterile filter 20160 Filter for feed water 25070 Stopper for sterile filter 74050 Filter with sieve insert 34010 Filter drying 70390 Filter in...

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