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Our certified quality management systems is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in accordance with ISO 13485 and ISO 9001. This guarantees that all MELAG products are manufactured and tested in accordance with strict quality criteria.
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The instructions are a part of the product. ® ® User Manual Vacuklav 40 B+ and Vacuklav 44 B+ Responsible for the contents: MELAG Medizintechnik oHG MELAG Medizintechnik oHG Geneststraße 6–10 10829 Berlin Germany E-mail: info@melag.de www.melag.de...
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Foreword Thank you for deciding to buy this premium class MELAG steam sterilizer. ® This User Manual describes both the steam sterilizers Vacuklav 40 B+ ® and Vacuklav 44 B+. They are identical except for their chamber depth and device depth.
MELAG devices are synonymous for long-term quality. When you eventually need to decommission your MELAG device, we offer a special dis- posal service. Simply contact your stockist.
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Check the pressure display of the manometer located on the steam sterilizer lower front side. Setting up, installation, ■ Only have the steam sterilizer set up, installed, and commissioned by people authorized by MELAG. commissioning ■ Only operate the steam sterilizer in areas which are not subject to explosion hazards.
■ Use the steam sterilizer only for the intended purposes outlined in the related technical documents and only in connection with the devices and components recommended by MELAG. Warning! ■ The sterilization of instruments and textiles with this steam sterilizer, like the foregoing instrument sterilization, is only to be done by com- petent personnel.
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Chapter 1 – Performance Specification Clean feed water The steam sterilizer works with a one-way feed water system. This means that it uses fresh purified feed water for every sterilization run. The quality of the feed water is constantly monitored via integrated conductivity meas- urement.
Chapter 1 – Performance Specification Overview of sterilization programs Universal- Quick- Quick- Gentle- Prion- Type tests Program Program B Program S Program Program Program type as per DIN EN 13060 Type B Type B Type S Type B Type B Dynamic pressure test of the sterili- zation chamber Air leak...
Chapter 2 – Device Description Chapter 2 – Device Description In this chapter you learn which components are included in the standard scope of delivery which components the steam sterilizer contains what safety devices the steam sterilizer has ...
Chapter 2 – Device Description Equipment views Front view Slot for the CF card Colour-touch display LED status bar Door (opens to the left) Protective cap for manometer to display the pressure of the double jacket steam generator Cap for emergency opening of the door Cap for emergency switch-on of the vacuum pump Mains switch (concealed, accessible from the side) Ethernet-1 data connection*...
Chapter 2 – Device Description Interior view Chamber Mounting to hold the load Door spindle Threaded bushing Chamber sealing surface Door seal Door plate Fig. 2: Interior view Effective capacity ® ® The steam sterilizers Vacuklav 40 B+ and Vacuklav 44 B+ differ only with respect to the respective depth of the units.
Chapter 2 – Device Description The control panel The control panel consists of a coloured 5 inch Touch Display. Status bar Menu bar Main display Action bar Symbols in the status bar Meaning Programs/Tests Indicates a program is running Indicates whether immediate output is activated/deactivated Immediate output Supplemental drying Indicates whether supplemental drying is activated/deactivated...
Chapter 2 – Device Description Symbols in the menu bar Meaning all sterilization programs and tests are found here, e.g. vacuum test, Programs/Tests Bowie & Dick Test, etc. the entire log list, logs from a defined time period, e.g. daily, monthly, etc Log output or specific log types can be found here such as the option to delete logs Settings...
Every MELAG steam sterilizer can be supplemented with a water treatment unit. NOTICE! Please first consult with MELAG if you would like to use water treatment units from other manufacturers. Supply with cooling water The pump for the vacuum creation is cooled with water.
Chapter 2 – Device Description Turning on the steam sterilizer Observe the following safety measures when handling the main power cable and the power plug: Danger ■ Do not splice or alter the power cable. ■ Do not bend or twist the power cable. ■...
Chapter 2 – Device Description Closing the door When closing the door of the steam sterilizer, observe the following instructions : Warning ■ Do not press the door too hesitantly against the steam sterilizer hous- ing. ■ Hold the door pressed closed for at least 3 seconds. ■...
Conditions for setting up, installing and commissioning ■ Only have the steam sterilizer set up, installed, and commissioned by people authorized by MELAG. ■ According to the currently valid VDE standards, this device is not Danger suitable for use in areas subject to explosion hazards.
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A position above or below the steam sterilizer is also possible. container The space requirements for the MELAG water storage container is 19 centimetres in width, 32 centimetres in height and 23 centimetres in depth, as well as additional space above for the tube connections.
A pressure hose is provided for the connection of the cooling water inlet at a customer-side faucet. NOTICE! In order to prevent water damage, MELAG recommends the use of a leak monitor. Cooling-water discharge The waste water hose can be connected as follows: On an existing rinsing drain when using the dual-chamber siphon ...
Chapter 4 – Sterilization Chapter 4 – Sterilization In this chapter you learn which prerequisites you must create for successful sterilization what you should observe on preparation of the items to be sterilized how you correctly load the steam sterilizer ...
Place trays or cassettes in the chamber only with the accompanying mounting. Use perforated trays, such as the trays from 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.
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This can ultimately lead to unsterile instruments and thereby to the endangerment of the health of the patient and the practice team. The MELAG sterilization containers satisfy all requirements for successful sterilization and drying. Stack sterilization containers...
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2.5 kg 9 kg Maximum total weight when using MELAstore 1) Tray mounts, trays, sterilization containers, standard tray cassettes from MELAG. 2) Other loading configurations in accordance with on-site validation Table 3: Loading variants, example of mounting C, and maximum load...
Chapter 4 – Sterilization Select program Select the sterilization program accordingly, depending on whether and how the sterilizing materials are wrapped. Furthermore, consider the re- sistance to high temperature of the items to be sterilized. All sterilization programs are displayed in the menu Programs & Tests.
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However, the steam sterilizer must be turned on again in time for the timer to progress again. ■ Unsupervised operation of electrical devices, including this steam sterilizer, is at the operator’s risk. MELAG accepts no liability what- soever for any damage resulting from unsupervised operation. Warning...
Chapter 4 – Sterilization Start program If you have selected a program with the navigation keys, it is displayed marked. You can now activate it by pressing the START key. The door locks pressure-proof as soon as the program starts. The steam sterilizer checks the quantity of the feed water and its conductivity.
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Chapter 4 – Sterilization Manually terminate program You manually terminate a running program in any of the phases. ■ Please note that hot water steam can escape upon opening the door after you terminate a program, depending on the time of the termina- tion.
Chapter 4 – Sterilization Sterilization phase is finished Sterilization successfully From a distance you can recognize from the display whether the steriliza- finished tion phase is already successfully completed. As soon as the drying phase is initiated, the coloured ring as well as the LED status bar change from blue to green.
Chapter 4 – Sterilization Release process According to RKI [Robert Koch Institute] - “Recommendations for hygiene in the preparation of medical products” the preparation of instruments ends with the documentation of release to storage and use of the sterilized products. The release process is comprised of the batch indication and the batch release and must take place by authorised and qualified personnel.
Chapter 4 – Sterilization Storage of sterilized items Only wrap items to be sterilized in wrappings that comply with the stand- ards. Do not store sterilized items in the preparation room. For the storage of the sterilized items, observe DIN 58953, Part 7 and the criteria below. Storage conditions Sealed against dust e.g.
Chapter 5 – Logging Chapter 5 – Logging in this chapter you learn Why and how you document batches Which output media you can employ for the batch documentation in which way Where you can find the logs for the batch documentation ...
MELAflash CF cards with a memory capacity of 1GB or more from MELAG. These are despatched in a certified and formatted state. It is known that some older CF cards with 256 MB memory capacity can cause file system problems.
Connect the MELAG network adapter (3) with the supplied cable (2) to an Ethernet data connection point of the steam sterilizer (see page 7, Fig. 1/(14) Plug the MELAG network adapter (3) into the serial connection of the ® printer MELAprint 42 (can be screwed).
The output for this log is offered at the next opportunity. MELAG recommends you use the automatic log output with immediate output of the log (according to the delivery status).
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Chapter 5 – Logging Example: Output all stored In the following example, read how you can output all stored logs onto the logs on CF card CF card. Prerequisite is that the CF card is plugged into the card slot. Select the menu Log output.
Chapter 5 – Logging Determine format for program log files One log report is stored in the internal log memory for every completed program. You determine with the logging format which of the stored data should be outputted. You can choose between a short form (0), a medium- sized form (1) and a long form (2).
Chapter 5 – Logging Reading log files correctly Header The header is outputted for all three selectable log report formats. The format 0 contains only the header of a log record. The header of the program log record comprises the lines 10 to 83 and contains the most important information for the completed program, such as whether the program was successfully concluded and the authenticity proof.
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>> Never change code on follow. line << Authenticity proof (electronic signature) 320000050082028D44A62A0A0FF103243194348C may never be changed; deciphering of the code by >> Authentication of batch log << MELAG permits inference whether the data was cre- ---------------------------------------- ated and changed on an steam sterilizer from MELAG. 0.00...
Chapter 5 – Logging Finding logs After a log output you will find a directory on the storage media CF card or Directory name, log file The name of this directory consists of five characters, e.g. 810RS. These name characters encrypt the serial number of your steam sterilizer. The directory is therefore also called the device directory.
Chapter 6 – Settings Chapter 6 – Settings In this chapter you learn Which settings you can make How you can change previous settings Setting date and time Observe time re-settings Date and time of the steam sterilizer must be correctly set for proper batch documentation.
PIN and should be changed on handing over. NOTICE! If you forget the Admin PIN, contact customer service at your suppli- er/MELAG. To delete a user from the list To delete a user from the list, read the following: Select the Settings menu as above, and open the user list.
Chapter 6 – Settings NOTICE! If the desired log printer is not displayed in the printer list, you can repeat this by repeated pressing of the printer symbol Setting up the label printer as a standard printer Read the following to set up the label printer: Select the Settings menu.
Chapter 6 – Settings Screensaver In order to save the display in standby, you can activate the Screensaver, so it will show a continuous slide show of random images. In order to activate the Screensaver and select the images for the slide show, follow the steps below: Select the Settings menu.
Chapter 6 – Function test Chapter 6 – Function test In this chapter you learn How the steam sterilizer automatically carries out the function test Which possibilities you have for the manual function test Which function tests should be conducted in daily operation ...
Chapter 6 – Function 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 chamber is measured within the measurement time.
Chapter 7 – Maintenance Chapter 7 – Maintenance In this chapter you learn How to clean the steam sterilizer and which cleaning agents are suitable How to avoid the formation of spots Which feed water to use How to oil the door spindle ...
Chapter 7 – Maintenance water storage container without fail with a litre of feed water. Avoid formation of spots Formation of spots due to Only if you correctly clean the instruments before sterilization can you improperly cleaned avoid the detachment of residues resulting from loading or instrument instruments preparation under steam pressure during the sterilization.
Maintenance ■ Have maintenance carried out only by trained field service techni- cians or technicians of the specialist trade. Turn to your specialist dealers or MELAG customer service in your vicinity. Danger ■ Comply with the predetermined maintenance intervals. Failure to observe these guidelines may lead to damage of the steam sterilizer and to serious injury to health.
This requires less energy to maintain the double jacket steam generator at the desired temperature. Pauses which last longer If the pauses between two sterilizations last longer than one hour, MELAG than one hour recommends that you switch off the steam sterilizer. You can save energy this way.
Chapter 8 – Operating pauses Event Possible cause What you can do conductivity too high Bad feed water Change the feed water or the mixed-bed-resin pellets for a ® MELAdem unit Despite running motor, Door seal is sticking to the Switch the steam sterilizer off and pull vigorously at the the door does not open sealing surface...
Chapter 8 – Operating pauses Empty double jacket You have the option of draining the water in the double jacket steam gen- erator easily via the program Draining. In order to do so, the steam sterilizer is heated once, building up pressure in the double jacket so that the water can be drained fully from the double jacket steam generator.
Chapter 10 – Errors Chapter 10 – Errors In this chapter you learn Which type of messages exist What you should do in case of errors What you can do before calling the Hotline What you can do if there are bad drying results ...
If you do not find the event in the table below or your efforts do not lead to success, turn to your specialist dealer or the authorised MELAG customer service centre in your vicinity. In order for us to help you, keep the serial number of your steam sterilizer and a detailed fault description in readiness.
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Chapter 10 – Errors Event Possible causes What you can do Ambient temperature too high Observe installation instructions (see page 14, Built-in steam sterilizer gets no or too little cooling Set-up location requirements). Check loading, observe instructions for loading Load the steam sterilizer).
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Event Possible causes What you can do Two years have elapsed since the initial commis- Call MELAG customer service or specialist sioning or since the last maintenance or 4000 dealers and make a maintenance appointment; sterilization programs have been completed...
Chapter 10 – Errors Bad drying results Apart from a proper device function, the drying process depends decisive- ly on the correct setting up and loading of the steam sterilizer. Check the correct set-up of the steam sterilizer. If necessary increase What you can do ...
Technical Specifications Technical Specifications ® ® Vacuklav 40 B+ Vacuklav 44 B+ Description Device dimensions (HxWxD) 56.5 x 47 x 58 cm 56.5 x 47 x 69 cm Sterilization chamber (WxD) Ø 25 cm x 35 cm Ø 25 cm x 45 cm Volume of the sterilization chamber 18.4 litres 23.8 litres Weight (empty)
Distilled water Technicians from depots or employees from service com- also aqua dest from lat. aqua destillata; is largely free of panies designated by MELAG that are trained by MELAG salts, organic materials and microorganisms, obtained by Batch the distillation (vaporising and subsequent condensation)
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Instrument oil [ DIN EN 13060] MELAG-Network adapter Evacuation Ethernet printer module for the MELAG printer Creation of a vacuum in a vessel ® MELAprint ; on one side is the printer connection, on...
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Glossary Porous small parts Sterilized items Made of materials which can absorb fluids (e.g. liquids) also designated as batch, if already successfully sterilized: sterile goods Process evaluation system Stainless steel cleaning agent Also self-monitoring system – observes itself, acts during the programs, compares sensors with each other e.g.
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