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5.20 Dear customer, 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.
Contents Contents 1 General guidelines ................................ 5 Symbols used.................................. 5 Formatting rules ................................... 5 2 Safety..................................... 6 3 Performance specifications .............................. 8 Intended use .................................. 8 Sterilization procedure ................................. 8 Type of the feed water supply .............................. 8 Safety equipment ................................. 9 Overview of the sterilization programs .......................... 9 Program sequences ................................ 10 Overview of programs ................................ 11 4 Description of the device.............................. 13 Scope of delivery................................ 13...
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Contents Deleting logs in the internal log memory .......................... 35 Reading logs correctly................................ 36 9 Function tests .................................. 38 Automatic functional checks............................... 38 Manual functional checks.............................. 38 Bowie & Dick test ................................ 38 Checking the quality of the feed water .......................... 39 Checking the preheating temperature of the chamber....................... 39 10 Maintenance.................................. 40 Servicing intervals ................................ 40 Cleaning ..................................... 40...
Make sure that you always have access to digital or printed version of the user manual. Should the manual no longer be legible, is damaged or has been lost, you can download a new copy from MELAG download centre at www.melag.com. Symbols used...
Check the device after unpacking for any damage suffered during transport. The device should only be setup, installed and commissioned by MELAG authorized persons. The connections for electrical provision and water supply and discharge must be setup by trained per- sonnel.
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(MELAG) and the relevant authority of the member state, in which the user and/or patient resides.
3 Performance specifications 3 Performance specifications Intended use The steam sterilizer is designed for use in a general medical environment in which the instruments used and their packaging do not require a type “B” steam sterilizer with cycles. According to EN 13060, this steam sterilizer is a sterilizer with the cycles of type “S”. As a universal steam sterilizer, it is suitable for the sterilization of unwrapped or wrapped solid instruments, simple hollow items and smaller quantities of textiles.
3 Performance specifications Safety equipment Internal process monitoring An process evaluation system is integrated in the electronics of the steam sterilizer. It compares the pro- cess parameters (such as temperature, time and pressure) during a program run. It monitors the parame- ters in terms of their threshold values during control and regulation and guarantees safe and successful sterilization.
3 Performance specifications Program sequences Regular sterilization program After program start, you can follow the program run on the display. It shows the chamber temperature and pressure as well as the time until the end of sterilization / the drying. Program phase Description 1.
3 Performance specifications Overview of programs MAIN menu Function Initial state (see next page) Press 1x hh:mm:ss AIN6: Conductivity Press simultaneously to reach the SETUP 0.00 bar 89°C 10 µS/cm menu function Release Select by holding the '-' key depressed Press 2x Unlock the door with the '+' key Universal-Program...
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Functions of the SETUP menu hh:mm:ss Initial state 0.00 bar 89°C Press both keys simultaneously No output medium MELAprint SETUP menu MELAflash Applies only to Vacuklav 23 B+/ 31 B+, Euroklav S+/ VS+, Vacuvet 23 B+, Function: MELAnet graphic data (MELAnet Box) DAC Professional Computer Applies only to Euroklav S+/ VS+...
4 Description of the device 4 Description of the device Scope of delivery Please check the scope of delivery before setting up and connecting the device. Standard scope of delivery ▪ Euroklav 23 S+ ▪ User manual ▪ Technical manual ▪...
4 Description of the device Rear panel Spring safety valve Sterile filter One-way outlet Feed water inflow via the internal storage tank Hose bridge for internal feed water supply Power cable View of the interior Fixing for MELAdem 40 Sterilization chamber Door locking pin Chamber sealing face 2x Device fuse...
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- it must be delivered to the vendor to be disposed of. MELAG devices are synonymous for long-term quality. When you eventually need to decommission your MELAG device, we offer a special disposal service. Simply contact your stockist.
4 Description of the device Operating panel The operating panel consists of a two-row alphanumerical LC display and four membrane keys. 14:27:12 0,02bar 25 °C 2-row LC display for display of the program status and parameters Time (h:min:s) Chamber pressure (bar) and (steam) temperature (°C) Function keys '-' and '+' for the selection, setting and display of special functions: printing, date / time, preheating, total batches, conductivity, acknowledge malfunction, '+' key for unlocking the door...
Record of installation and setup The record of installation and setup is to be completed by the responsible stockist and a copy sent to MELAG as proof of the correct setup, installation and initial commissioning. This is a constituent part of any guarantee claim.
5 First steps Repeated pressing of the 'S' key enables you to leave the menu entirely and return to the display basic state. Wastewater connection The wastewater can either be collected in the internal storage tank on the wastewater side (left) and be re- moved manually or be let out automatically via the one-way outlet.
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5 First steps Navigate in the Function menu using the '+' or '-' keys until the display shows: Function Date / time Press the 'P' key to confirm. Ê The current hour is displayed. Choose one of the following setting possibilities using the '+' or '-' keys: hour, minute, second, day, month, year.
6 Loading the steam sterilizer 6 Loading the steam sterilizer Preparing the sterilization material Cleaning and disinfection must always have been performed correctly and appropriately before steriliza- tion. Only in this way is it possible to guarantee the subsequent sterilization of the sterilization material. The materials used, cleaning agents and reprocessing procedure are of decisive significance.
Insert trays or cassettes in the chamber only with their appropriate mount. Use perforated trays such as those from MELAG. Only in this way can condensate drain off. The use a non-perforated base or half-shell to accommodate the sterilization material can result in poor drying results.
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Ensure that the perforations are not covered when stacking the containers. Tip: MELAG sterilization containers fulfil the requirements of EN 868-8 for successful sterilization and dry- ing. They have a perforated lid and base and are fitted with disposable paper filters.
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Max. weight per component 2 kg / 0.6 kg Maximum total weight** 4 kg / 0.6 kg For MELAG mounts, trays, sterilization containers, see Accessories and spare parts [} page 58] This applies solid loads (e.g. instruments) including the weights of mounts, trays and sterilization containers.
This will shorten the cycle times and reduce the condensate formation on the chamber wall. PLEASE NOTE The steam sterilizer must remain continually activated for the automatic preheating. MELAG recommends activating the automatic pre-heating function.
NOTICE Unsupervised operation of electrical devices, including this steam sterilizer at the operator’s risk. MELAG accepts no liability what so ever for any damage resulting from unsupervised operation. After having selected a program via the program selection key 'P', the display will show both the selected program and sterilization temperature as well as whether the program is suitable for wrapped or un- wrapped sterilization material.
7 Sterilization Program run After starting the program, you can follow the program run in the display. It shows the chamber tempera- ture and pressure as well as the time until the end of sterilization or the drying time which has passed. 1.
7 Sterilization Manual program abort You can abort a current program in all phases. If you end a program before drying begins, the sterilization material remains unsterile. WARNING Hot steam can be released from the device when opening the door after a program abort. This could result in burns.
7 Sterilization Program abort after the start of drying You can abort the program during the drying phase via the 'S' key without the steam sterilizer registering a fault. Should you abort a program after drying has started, the sterilization is having been completed successful- ly.
7 Sterilization Comply with the following specifications when removing the sterilized equipment: Never use force to open the door. This could damage the device or result in the emission of hot steam. Use a tray lifter to remove the tray. Never touch the sterilized equipment, the chamber, the mount or the inside of the door with bare hands.
8 Logging 8 Logging Batch documentation The batch documentation serves as proof of the successful conclusion of the program and represents an obligatory part of quality assurance. The device internal log memory saves such data as the program type, batch and process parameters of all the programs completed. To obtain the batch documentation, you can output the internal log memory and transfer its data to various output media.
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8 Logging In its delivery state, an option for log output is not set on the steam sterilizer. PLEASE NOTE Further information about the log printer (e.g. the duration of the readability of the log printouts) is specified in the appendant user manual. Using a computer as an output medium (without a network connection) In order to be able to use a computer as an output medium, the computer must be connected to the steam sterilizer via the serial interface.
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8 Logging Press the 'P' key again. If an output medium has yet to be chosen, the display will show the Log output – No output medium notification. Navigate using the '+' or '-' keys until the display shows: Output medium Computer Press the 'P' key to confirm.
8 Logging Mark the editor and confirm with “OK”. Ê You can then open files with this ending via a double-click in Windows Editor. Alternatively, you can open all text logs with the documentation software MELAtrace/MELAview (from MELAview 3). Outputting logs immediately and automatically Text logs If you want to output the associated text log on an output medium automatically and immediately after the end of a program, use the following function: Immediate output YES.
8 Logging PLEASE NOTE If immediate output is unable to output a log, for example, because the output medium activated is not connected, a warning will appear. MELAG recommends using the immediate log output function. Graphic logs For log output immediately after program end, comply with the following: In SETUP menu Function: Log output MELAnet+graphic data must be selected as the...
8 Logging Navigate using the '+' or '-' key until the display shows: Output stored cycles Press the 'P' key in order to start the output of the selected program. The display will show the message during the output: Output. Ê If output has been performed, the display will show: Output stored cycles.
8 Logging Press the 'P' key to leave the menu after deletion. The display will show Function: Log output. Repeated pressing of the 'S' key enables you to leave the menu entirely and return to the display initial state. Reading logs correctly Log type File ending Explanation...
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8 Logging Example for a text log of a successfully completed program Steam sterilizer type ---------- started program current date time at program start daily batch number serial number preheating temperature conductivity of the feed water VALUES OF THE PROGRAM STEPS program sequence phases with the accompanying values for pressure, temperature and time (relative to the program start)
9 Function tests 9 Function tests Automatic functional checks The electronic parameter control subjects the interaction of the sterilization-relevant parameters pressure, temperature and time to constant automatic monitoring. The steam sterilizer process evaluation system compares the process parameters during the program with each other and monitors them in terms of their threshold values.
9 Function tests Checking the quality of the feed water You can access the water quality on the display at any time during a current program when the steam ster- ilizer is switched on. AIN6: Conductivity 15 µS/cm To do so, hold the '-' key depressed until the display shows Conductivity. Ê...
Comply with all information regarding cleaning of the part affected. Sterilization chamber, chamber sealing face, mount, trays To maintain the value of your device and to avoid stubborn contamination and deposits, MELAG recom- mends weekly cleaning of the surfaces (e.g. with the MELAG chamber cleaning set).
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10 Maintenance Finally, wipe the cleaned surfaces with a dry, non-fuzzing microfibre cloth. Housing parts Where necessary, clean the housing parts with a neutral fluid cleaner or spirit. Internal storage tank Should you use the internal storage tank for the feed water supply, perform regular checks and cleaning. Interval Measure Each time you fill up...
10 Maintenance Avoiding staining Only proper cleaning of the instruments prior to sterilization enables you to avoid residue from being re- leased from the load under steam pressure during sterilization. Loosened dirt residue can clog the filter, fit- tings and valves of the device and deposit themselves on the instruments and in the sterilization chamber as deposits and stains.
10 Maintenance Insert the door seal in the groove of the round blank. PLEASE NOTE Make sure that the broad seal face faces the chamber. The door can only be shut correctly and the chamber sealed, if the door seal sits correctly in the groove. Replacing or sterilizing the sterile filter The sterile filter must be replaced regularly within the scope of the maintenance.
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10 Maintenance Exert a little pressure on the sterile filter and turn to insert it into the holding sockets. Sterilizing the sterile filter Remove the sterile filter by turning and pulling it from the holding sockets simultaneously. Slide a into the steam sterilizer and place the sterile filter vertically on the tray.
10 Maintenance Cleaning the filter in the chamber Unscrew the two fixing screws on the metal cover in the sterilization chamber (using e.g. a coin) and remove the metal cover. Unscrew the “condensate return” (pos. a) and “vacuum / flow” (pos. b) filters anti-clockwise out of the opening to check and clean.
11 Pause times 11 Pause times Frequency of sterilization Pause times between individual programs are not necessary. After the end/abort of the drying time and re- moval of the sterile material, you can load the steam sterilizer again and start a new program. Operating pauses Depending on the duration of the operating pauses, the following measures must be maintained: Duration of the operating pause...
11 Pause times Transport Transport within the practice NOTICE Failure to observe these provisions can result in damage to the device and malfunction. Comply with the following provisions when transporting within a room or the practice: When using a water treatment unit and/or an outlet hose, close the water inflow and remove the hose connections on the rear of the device.
Should the following table not contain the relevant event, or your efforts do not redress the problem, you can contact your nearest stockist or a local authorized MELAG customer service provider. Please have your device serial number and a detailed description of the malfunction contained in the notification to...
The installed flow authorized customer services/stockist monitor does not close. technician. When using a MELAG water treatment unit: The warning will be displayed after a MELAdem 40/53/53 C: program start. The installed flow Check the water treatment unit and open monitor does not close.
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12 Malfunctions Event Possible causes What you can do Insufficient quality of Feed water conductivity too high. Start no longer possible. feed water / start not See event: Poor feed water / replace the Conductivity ≥ 65 µS/cm possible cartridge or module. Please wait, the This display appears during the The steam sterilizer starts automatically...
12 Malfunctions Fault messages Event Possible causes What you can do The overheat protection has tripped. Press the overheat protection reset button on the fore side of the steam sterilizer at the bottom right- hand side (behind the panel) back in. The steam sterilizer is overloaded.
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12 Malfunctions Event Possible causes What you can do The overheat protection of the tubular Allow the steam sterilizer to cool for approx. 2 min heating element has triggered. and then restart the program. PLEASE NOTE: This notification can be issued if a program is started immediately after a malfunction or a program abort.
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12 Malfunctions Event Possible causes What you can do The steam sterilizer was switched off at Replace or sterilize the sterile filter as follows: the power switch during a program run. Remove the sterile filter from the rear panel of the steam sterilizer and sterilize it in the Gen- tle-Program without continuing loading.
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12 Malfunctions Event Possible causes What you can do see event F23 The door seal and/or the seal face on Check the door seal and the seal face on the the sterilization chamber is soiled or the sterilization chamber for soiling and foreign bodies door seal is defective.
12 Malfunctions Opening the door in an emergency following a power outage WARNING The steam sterilizer must be completely pressure free. Failure to observe this provision can result in scalding / injury. No steam may be permitted to leave from between the sterile filter and the rear panel of the steam sterilizer.
12 Malfunctions Replacing the device fuses If the device fuses have been tripped, proceed as follows to change them: Switch off the steam sterilizer at the mains and remove the plug from the socket. Open the door manually, see Opening the door in an emergency following a power outage [} page 55].
Depending on the load, the weight can increase by up to 4 kg. When using a water treatment unit, take into account its additional weight. When using a water treatment unit Optional: automatically via the one-way drain with the MELAG upgrade kit for the tank drain...
14 Accessories and spare parts 14 Accessories and spare parts You can obtain the specified articles and an overview of further accessories from your stockist. Category Article Art. no. Mounts Mount A Plus 82630 for 5 trays or 3 sterilization containers Mount D 46840 for 2 high cassettes or 4 trays...
Insurance). The regulation 1 governs the prin- ployee of a customer service provider or stockist ciples of prevention. who has been trained and authorised by MELAG to perform maintenance and installation work on DIN 58953 MELAG devices. Only they may carry out this Standard –...
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Glossary Heat-up phase Soft sterilization packaging The time required after the steam sterilizer has e.g. a paper bag or transparent sterilization pack- been switched on / after the start of a sterilization aging program, to heat the double-jacket steam genera- tor before the sterilization procedure starts.
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MELAG Medizintechnik GmbH & Co. KG Geneststraße 6-10 10829 Berlin Germany Email: info@melag.com Web: www.melag.com Original instructions Responsible for content: MELAG Medizintechnik GmbH & Co. KG We reserve the right to technical alterations Your stockist...
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