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5.15 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.
Contents Contents 1 General guidelines ................................ 5 Symbols used.................................. 5 Formatting rules ................................... 5 Symbols on the device ................................. 5 2 Safety..................................... 7 3 Performance specifications .............................. 9 Intended use .................................. 9 Sterilization procedure ................................. 9 Type of the feed water supply ............................ 10 Safety equipment ................................ 10 Overview of the sterilization programs .......................... 11 Program sequences ................................ 11 Overview of programs ................................ 12 4 Description of the device.............................. 14...
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Contents Deleting logs in the internal log memory .......................... 35 Reading logs correctly................................ 35 9 Function tests .................................. 37 Automatic functional checks............................... 37 Manual functional checks.............................. 37 Bowie & Dick test ................................ 37 Checking the quality of the feed water .......................... 38 Checking the pre-heating temperature of the chamber...................... 38 10 Maintenance.................................. 39 Servicing intervals ................................ 39 Cleaning ..................................... 39...
Please store these user manual carefully and in close proximity to your device. It represents a component of the product. Should the user manual no longer be legible, damaged or lost, please obtain a new copy from MELAG. State the device type and your address in an e-mail.
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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...
Check the device for any damage suffered during transport after unpacking. The device should only be set-up, installed and commissioned by MELAG authorized persons. The connections for electrical provision and water supply and effluent must be set-up by trained per- sonnel.
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Maintenance Have the maintenance done only by authorized persons. Maintain the specified servicing intervals. Only original MELAG spare parts may be used. Malfunctions Should the device issue the same malfunction message repeatedly, turn off the device and if necessary, inform your stockist.
Only ever use the steam sterilizer for the applications as foreseen in the technical documentation and only in connection with the devices and components as recommended by MELAG. As with the preceding instrument decontamination and in accordance with §2 MPBetreibV, the sterilization of instruments and textiles using this steam sterilizer may only be carried out by competent personnel.
3 Performance specifications Type of the feed water supply The steam sterilizer works with both a one-way feed water system and following the feed water circulation system. The one-way feed water system uses fresh demineralized or distilled feed water for every sterilization procedure.
3 Performance specifications Overview of the sterilization programs The results in this table show which inspections were performed on the steam sterilizer. The marked fields demonstrate compliance with all the applicable sections of the standard DIN EN 13060. Table 1: Overview of the sterilization programs Type tests Universal- Quick-...
3 Performance specifications Overview of programs MAIN menu Function Initial state (see next page) Press 1x hh:mm:ss Press simultaneously to reach the SETUP AIN6: Conductivity 0.00 bar 89°C menu 10 µS/cm Release function Select by holding the '-’ key depressed Press 2x Unlock the door with the '+’...
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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 Function of the MELAflash MELAnet graphic data SETUP menu: Applies only to Vacuklav 23 B+/ 31 B+, Euroklav S+/ VS+ Computer Modem Applies only to Euroklav S+/ VS+ Last batch number:...
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 Views of the device Tank lid Operating and display panel Door, swings open to the left Slide seal grip Power switch Front device foot (adjustable) Fig. 1: Front Spring safety valve Sterile filter One-way discharge Feed water inflow via the internal storage tank Hose bridge for internal feed water supply...
4 Description of the device Fixing for MELAdem 40 Chamber Door locking pin Chamber sealing face 2x device fuses Overheat control reset button Serial data and printer connection (RS232)* Connection for emptying the storage tank - feed water Connection for emptying the storage tank - wastewater 21 20 Door seal...
4 Description of the device Load mounts The steam sterilizer is always delivered with a mount for holding trays or cassettes. Detailed information regarding the various mounts, their combinability with various load holders and their application can be found in the operating manual “Usage instructions for mounts”. Mount A "Plus"...
Record of installation and setup The record of installation is to be completed by the responsible stockist and a copy sent to MELAG as proof of the correct set-up, installation and initial commissioning. This is a constituent part of any guarantee claim.
5 First steps Wastewater connection The wastewater can either be collected in the internal storage tank on the wastewater side (left) and be removed manually or be let out automatically via the one-way drain. An upgrade kit can be ordered to connect the steam sterilizer to the wastewater.
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5 First steps Confirm with the 'P’ key to save. The current value set no longer flashes on the display. Proceed in a similar fashion to alter the other parameters. After ending the settings, press the ‘S’ key to leave the menu. The display will show Function: Date / Time.
6 Loading the steam sterilizer 6 Loading the steam sterilizer Preparing the sterilization material Cleaning and disinfection must always have been performed before sterilization. Only in this way is it possible to guarantee the subsequent sterilization of the sterilization material. The materials used, the cleaning fluid and treatment procedures used 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 DIN EN 868-8 for successful sterilization and drying. They have a perforated lid and base and are fitted with disposable paper filters.
7 Sterilization 7 Sterilization Selecting the program You can switch between the initial state and the desired program using the program selection switch ‘P’. Now select the sterilization program according to how and whether the sterilization material is packed. It is also necessary to take into account the temperature resistance of the sterilization material.
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...
7 Sterilization unwrapped sterilization material. Universal-Program 134 °C wrapped Press the ‘S’ key to start the program. The steam sterilizer checks the feed water supply and its conductivity. PLEASE NOTE If the Quick-Program S has been started, the warning Attention: Unwrapped instruments only appears on the display.
7 Sterilization Program end When the program has been completed successfully, the display shows: Universal-Program successfully ended Working in SETUP menu Function under Last batch number if immediate output after program end is activated, the log of the completed program will be outputted to the activated output medium after opening the door, see Logging.
7 Sterilization the end of the drying phase as far as is possible. Unwrapped instruments sterilized in a Quick-Program dry after being removed from their own warmth. The drying time completed thus far is indicated on the display during the drying phase. This will alternate with the display of: Immediate removal press 'STOP'...
7 Sterilization Check the packaging on the sterilized equipment for damage when removing it from the device. Should the packaging be damaged, re-pack the sterilization material and re-sterilize it. Storing sterile instruments The maximum storage time is dependent on the packaging and the storage conditions. For standard- conform packaged sterilized equipment –...
8 Logging 8 Logging Batch documentation The batch documentation acts as proof of the successful conclusion of the program and represents an obligatory part of quality assurance (MPBetreibV). 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 ▪ MELAnet Box 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 print-outs) is specified in the appendant operating 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 Navigate using the '+' or '-' keys until the display shows: Output medium Computer Press the ‘P’ key to confirm. The display switches back into the Log output – Output medium menu. Press the ‘S’ key to return to the SETUP menu Function: Log output. After repeated pressing of the ‘S’...
Pressing the ‘S’ key once again enables you to leave the menu and return to the display initial state. PLEASE NOTE If immediate output is unable to issue a log, for example, because the output medium activated is not connected, a warning will appear. MELAG recommends using the immediate log output function. Subsequent log output It is possible to output logs subsequently and independently of the time of the end of the program.
8 Logging After a successful output, the display returns to its previous setting and shows: Last cycle output: 25 Repeat the last three steps in order to output further logs. Press the ‘S’ key to leave the submenu without outputting the log. Press the ‘S’...
8 Logging Navigate using the '+' or '-' keys until the display shows the number of logs saved: Allocated: 26 Free: Press the ‘S’ key twice to leave the menu. Deleting logs in the internal log memory Delete the saved logs manually to suppress the warning Protocol memory full with the option Immediate output NO set.
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8 Logging HEADER ---------- 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) SUMMARY control message...
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 sterilizer s switched on. AIN6: Conductivity 15 µS/cm To do so, hold the '-' key depressed until the display shows Conductivity. The conductivity is displayed in µS/cm.
10 Maintenance 10 Maintenance Servicing intervals Interval Measure Device components Weekly Check for soiling, deposits or Chamber inc. door seal and chamber damage sealing face, mount for the load After 24 months or Maintenance By the authorized customer services 1000 cycles working in accordance with the maintenance instructions.
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10 Maintenance Internal storage tank Should you use the internal storage tank for the feed water supply, perform regular checks and cleaning as follows: Interval Upon every refill Check the storage tank for soiling. If necessary, use a cloth and fresh feed water to clean the storage tank before filling.
10 Maintenance Avoiding staining Only after cleaning instruments properly prior to sterilization is it possible to avoid residue from the load or the instrument decontamination from being released during sterilization. Loosened dirt residue can clog the filter, nozzles and valves of the steam sterilizer and deposit themselves on the instruments and 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 when inserting. 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 perforated tray 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 removal of the sterilized equipment, 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...
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 the inflow to the system if necessary.
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Conductivity ≥ 40 µS/cm When using a MELAG water treatment unit: The mixed-bed resin is exhausted. MELAdem 40: replace the mixed-bed resin (art. no. 61026), see the operating manual of the MELAdem water treatment unit.
12 Malfunctions Incident Possible causes What you can do Log memory full The internal log memory of the The notification is displayed upon program device is full (max. 40 logs possible) start Repeated pressing of the ‘S’ key removes the message and the program starts. The oldest log will be deleted in the process.
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12 Malfunctions Incident Possible causes What you can do The “condensate return” filter is soiled. Unscrew the two fixing screws on the metal cover in the sterilization chamber with an object e.g. a coin. Remove the metal cover. Unscrew the “condensate return” filter (in the rear of the sterilization chamber).
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12 Malfunctions Incident Possible causes What you can do The maximum preheating temperature Upon repeated incidence, contact an authorized has been exceeded customer services/stockist technician. The pressure release of the sterilization Unscrew the “flow” filter (in the fore area of the chamber is blocked.
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12 Malfunctions Incident Possible causes What you can do The sterilization temperature on Comply with the maximum permissible load temperature sensor 1 was undercut. quantities, see Loading versions. The steam sterilizer may be overloaded. 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...
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12 Malfunctions Incident Possible causes What you can do 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 (see views of the device) 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.
When using a water treatment unit, take into account its additional weight. When using a water treatment unit In the Prion-Program a with porous full load. Optional: automatically via the one-way discharge 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 standard tray cassettes or 3 MELAstore-Boxes 100 Mount B 40224...
DIN 58953 Standard – sterilization, sterile equipment supply Authorized personnel An authorized personnel can be medical stockists, DIN EN 13060 depot technicians or MELAG-authorized customer Standard – small steam sterilizers services trained by MELAG. DIN EN ISO 11607-1 Batch Standard - packaging for medical devices to be...
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Glossary MELAG network adapter Solid Ethernet printer module for the MELAprint 42/44 Without hollows or gaps, solid, compact, closed log printer; a printer connection on one side and a network connection on the other Solid load Serves to prove that the necessary sterilization...
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MELAG Medizintechnik oHG Geneststraße 6-10 10829 Berlin Germany email: info@melag.com Web: www.melag.com Responsible for content: MELAG Medizintechnik oHG We reserve the right to technical alterations Your stockist...
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