Steam sterilizer from software version 5.20 (26 pages)
Summary of Contents for MELAG Vacuklav 40 B+ Evolution
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3.240 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.
Disposal MELAG devices are synonymous with high quality and a long life-span. When you eventually need to de- commission your MELAG device, the required disposal of the device can take place with MELAG in Berlin. Dispose of accessories and consumption media which you no longer require in the appropriate manner.
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1 General guidelines MELAG draws the operator’s attention to the fact that they may be legally obliged (e.g. in Germany ac- cording to ElektroG) to remove used batteries and accumulators non-destructively before handing over the device, provided they are not enclosed in the device.
Check the device after unpacking for any damage suffered during transport. The device should only be setup, installed and commissioned by MELAG authorised 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 This steam sterilizer is designed for application in a medical context, e.g. general practitioners and dental practices. According to EN 13060, this steam sterilizer is considered as a steam sterilizer with type B cy- cles.
3 Performance specifications whilst it opens. Pressure compensation will have been performed by the time that the door is completely open, even following pressure differences. Quantity and quality of the feed water The quantity and quality of the feed water is automatically checked before every program start. Performance characteristics of sterilization programs (type B) The results in this table show which inspections were performed on the steam sterilizer.
3 Performance specifications Program sequences A program runs in three main phases: the air removal and heating up phase, the sterilization phase and the drying phase. 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 / drying.
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 ▪ Vacuklav 40 B+ or Vacuklav 44 B+ ▪ User manual ▪...
4 Description of the device Views of the device CF card slot Colour touch display LED status bar Energy-saving key Door (swings open to the left) Opening for door opening in an emergency* Opening for emergency activation of the vacuum pump Power switch (covered, accessible from the side) Ethernet connection...
4 Description of the device Mount for the water treatment unit MELAdem Spring clip for fixing the mount “Plus” Door spindle Sterilization chamber Chamber sealing face Door seal Round blank Bushing Fig. 3: View from front, door open Service hatch The service hatch is opened by pressing on the recess. The service hatch is closed again by closing and pressing on the recess.
- 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 Energy-saving key Pressing the energy-saving key activates the energy-saving mode and switches off the display. The dou- ble jacket will not be heated until the next program start. This corresponds to waiting time 2, see also Ener- gy-saving mode [} page 62].
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4 Description of the device Symbols in the status bar Meaning Energy-saving Indicates whether the steam sterilizer is currently in energy-saving mode mode Service area Indicates whether a service technician is logged-in to the service area CF card status Indicates whether a CF card has been inserted and whether a reading or writing action is in process Symbol in the menu bar Meaning...
4 Description of the device LED status bar The status bar on the lowest edge of the display indicates different situations with various colours. Colour of the LED Meaning Blue Standby, program running, drying has not yet begun Green Drying running, program completed successfully Yellow Warning message, software update is running Malfunction message, program not completed successfully...
A water treatment unit is connected to the drinking water supply. This obviates the need to fill the storage container. The respective system is selected in accordance with the number of sterilization runs per day and the type of the load. Every MELAG steam sterilizer can be fitted with a water treatment unit. PLEASE NOTE Should you wish to use a water treatment unit from another manufacturer, please consult MELAG.
5 First steps Switching on the steam sterilizer Video tutorial See also "Operation". The following must be fulfilled or present: ü The steam sterilizer is connected to the electricity supply. ü The feed water supply is secure. The steam sterilizer requires approx. 3 litres feed water for the first filling of the steam generator.
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5 First steps PLEASE NOTE The door is to be left open only whilst loading and unloading the steam sterilizer. Keeping the door closed saves energy. Closing the door To close the door, press it firmly inwards until the automatic door lock engages. After the door has been closed, the display returns to the program menu.
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5 First steps Remove the cover cap in order to facilitate emergency door-opening (pos. b) by pushing out (e.g. with a small narrow slotted screwdriver). Insert the 5 mm Allen key included in the scope of delivery in the opening. The Allen key can be stored in the bracket behind the service hatch intended for this purpose.
6 Loading the steam sterilizer 6 Loading the steam sterilizer Preparing the load Always clean and disinfect properly before sterilization. Only in this way is it possible to guarantee the sub- sequent sterilization of the load. The materials used, cleaning agents and reprocessing procedure are of decisive significance.
Use aluminium sterilization containers. Aluminium retains and conducts heat and thus accelerates drying. Closed sterilization containers must be either perforated or have a valve on at least one side. MELAG sterilization containers (e.g. MELAstore Boxes) fulfil the requirements for successful sterilization and drying.
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6 Loading the steam sterilizer Soft sterilization packaging Soft sterilization packaging can be used in both sterilization containers and on trays. Please comply with the following when using soft sterilization packaging e.g. MELAfol: Arrange soft sterilization packaging in a perpendicular position and at narrow intervals. Place transparent sterilization packages on their edge wherever possible and with the paper side facing downwards.
MELAcontrol Pro (see above). The use of another test system in accordance with EN 867-5 is possible. The number of the available test systems means that MELAG is not able to provide technical support when using a different system. PLEASE NOTE Document the results of the tests.
7 Sterilization Selecting the program Video tutorial See also "Program selection". Select the sterilization program according to whether and how the load is packed. You must also consider the temperature resistance of the load. All sterilization and additional programs are displayed in the Pro- grams &...
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. This function enables you to select any program and start it at a time of your choice. The start time pre-se- lection is only active for the unique time and program selection.
7 Sterilization For example, to change the time, tap directly on the parameters Hour or Minutes. The selected field is highlighted light blue. Change e.g. the hour by pressing the pushbuttons Then press START. The display remains in the start time pre-selection window. Ê...
7 Sterilization Program run A program runs in three main phases: the air removal and heating up phase, the sterilization phase and the drying phase. 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 / drying.
7 Sterilization Confirm with [ENTER]. Now you can display the program run or information about your steam sterilizer (e.g. serial number, device software version and selected values). Manual program abort You can abort a current program in all phases. If you abort the program before drying begins, the load re- mains unsterile.
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7 Sterilization Confirm the security query with YES. After a short time, you can open the door by pressing symbol. The display shows a warning; the log records the sterilization as NOT successful. Program abort after the start of drying Should you abort a program after drying has started, the sterilization is having been completed successful- ly.
7 Sterilization Confirm the security query with YES. After a short time, you can open the door by pressing the door symbol Program end When the program has ended successfully, the corresponding message will be issued on the display. Be- fore opening the door, you can view further values on the display from the program which has just com- pleted, e.g.
7 Sterilization Batch indication comprises the checking of the indicators used in the sterilization program e.g. MELAcontrol Helix or MELAcontrol Pro. Approval of the indicator strip is possible only if it changes colour entirely. Batch approval comprises the checking of the process parameters using the sterilization results on the steam sterilizer and the sterilization log as well as checking of the individual packaging for damage and re- sidual moisture.
7 Sterilization Storing sterile material The maximum storage time is dependent on the packaging and the storage conditions. Please observe the regulatory requirements for the storage period of sterile materials (in Germany e.g. DIN 58953, Part 8 or the DGSV guidelines) as well as the following listed criteria: Comply with the maximum storage duration in accordance with the packaging type.
8 Logging 8 Logging Batch documentation Video tutorial See also „Process 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.
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8 Logging Proceed as follows in order to insert the CF card in the slot. ü The CF card is set as the output medium in the Settings > Logging menu. Insert the CF card in the card slot fully with the raised finger edge pointing rightwards and to the rear.
PLEASE NOTE To facilitate easy assignation of a package marked with a label to a specific batch, the sterilization log file name must not be changed. Type, serial number MELAG 40 B+ 201740-B0112 05.04.2018 / 04.10.2018 Sterilization date/Storage duration Batch 03/00019 Daily batches/no.
8 Logging The following points must be fulfilled for immediate output: The date and time have been set correctly. The output medium must have been selected and connected. Immediate output must be activated in Menu Settings > Logging. Information regarding the setting of immediate output and the desired output medium is provided in the chapter Settings, logging [} page 45].
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8 Logging Outputting a log from the log list Proceed as follows to output a specific log from the internal memory: Navigate to menu Log output and select Logging list. A list is displayed with all text logs that have been saved in the internal memory.
When transferring the logs to a CF card, they will be stored in a separate folder in the main directory. Di- rect transfer of the logs to a computer via the network and using the MELAG FTP server allows you to work directly in the FTP server to determine directly where on your computer the device directory with log files is to be saved.
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>> Never change code on follow. line << 010041D8BE14B1319E55772A0DF975054F7EBF32 EE1372767ED3B3801EB10F3FB01A3212D41D7144 Proof of authenticity (electronic signature) 1C3B8B6474777962766F018680B68C56C219074F Should never be altered; decoding the code (by MELAG) D6E7814D506F0A2F3077782541CC2CD05C425DA1 indicates whether the data was generated on a MELAG 9A5EF5192C68174C868556542F7B8B05E97C6E46 steam sterilizer and has been changed.
9 Function tests 9 Function tests 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. The test programs enable you to per- form an additional function check at any time.
9 Function tests Bowie & Dick test The Bowie & Dick test serves as proof of steam penetration of porous materials such as e.g. textiles. You can perform a routine function check for proof of steam penetration. Use test program Bowie & Dick test for this purpose. Specialist stockists provide various test systems for the Bowie & Dick test. Depend- ing on the application, use either a test system for hollow body instruments or for porous load (laundry etc.).
10 Settings 10 Settings Logging All settings pertaining to the output of text and graphic logs i.e. output medium, log format, immediate out- put etc. are performed in menu Settings > Logging. To this end, you are led through a settings wizard. Immediate log output In its delivery state, the immediate output of the text and graphic logs via the CF is activated.
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10 Settings If you wish to output a graphic log (optional) in addition to a text log, proceed as follows: ü You are in menu Settings > Logging. ü Immediate output is activated. Set a checkmark next to Graphic logs and check whether the checkmark is also set next to Immediate output.
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10 Settings Explanation of the possible settings for graphic recording: Interval Explanation CF card recording interval in seconds – Indicates the time intervals in which the program curve is recorded on the CF card. The smaller the time interval, the more exact the curve. In the example, the time interval is set to one second.
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10 Settings Press CONTINUE until you reach the output media selection window. Select the computer as an output medium and press CONTINUE. Ê The selection window opens and asks whether the connection to the computer should be effected via FTP or TCP. Connection via FTP ü...
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10 Settings Connection via TCP ü A suitable documentation software e.g. MELAtrace is installed. Select Connection via TCP. The TCP port currently set is displayed on the lower pushbutton (Standard TCP port: 65001). Press on the lower pushbutton to change the pre-set TCP port.
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10 Settings If a device is to be integrated in a pre-existing (practice) network, observe and comply with the following: ü The IP addresses listed in the table have not yet been assigned in the (practice) network. ü The device cannot be automatically administered in a dynamic (practice) network (i.e. a DHCP network).
10 Settings You can choose between the following formats. Format Description Format 0 Short form - only the log header is outputted. Format 1 The log header and the program steps are outputted. Format 2 Standard format - in addition to the log header and the program steps, a key is displayed explaining the individual program steps.
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10 Settings Select a free ID and select EDIT in order to create a new user. The first ID is reserved for the Admin PIN. Enter a 4-digit PIN in the right-hand key pad for the selected user ID. Accept all the settings with SAVE, then leave the menu.
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10 Settings Changing the Admin PIN PLEASE NOTE If you forget the Admin PIN, consult your stockist/MELAG customer services provider. The Admin PIN (standard: 1000) can be edited like every other User PIN and should be changed after de- livery.
10 Settings Set a checkmark next to Batch approval with user PIN, to perform user authentication upon every program end. The device door will open following program end only after the user PIN has been entered. Set a checkmark next to PIN entry can be skipped to enable the user PIN query to be skipped.
10 Settings To start formatting, press the OK button. Confirm the security query with YES. You can remove the CF card as soon as formatting has been completed. Additional drying Selecting additional drying extends the drying time of conventional drying by 50 %. Activating intelligent drying restricts the criteria for ending the drying phase.
10 Settings Intelligent drying In contrast to a conventional time-controlled drying procedure, with which the duration of the drying phase is determined by the program, the duration of the intelligent drying is automatically calculated using the re- sidual moisture in the sterilization chamber. A number of factors play a role in this process including e.g. the type of the load, wrapped or unwrapped, the load quantity, the distribution of the load in the sterilization chamber etc.
10 Settings Brightness Select menu Settings > Brightness. The display switches to the settings window. Press the pushbutton to adjust the brightness and contrast on the display. Accept all the settings with SAVE and then leave the menu. Volume Select menu Settings > Volume. The display switches to the settings window.
10 Settings View You can choose between classic and modern view. Switching from MODERN to CLASSIC Select the Settings > View menu. The display switches to the settings window. Press the CLASSIC button. The design changes immediately. Press CONTINUE. Tap on a colour box to change the background colour, e.g.
Confirm the settings with SAVE. The display changes automatically to the Settings menu. MELAconnect The MELAconnect app is used to monitor the preparation processes of your MELAG steam sterilizers on the mobile end device (e.g. smartphone, tablet). The following must be fulfilled or present: ü...
10 Settings Follow the instructions in MELAconnect and read in the QR code to connect your device to MELAconnect. Alternatively, you can enter the IP address of your device in MELAconnect manually. Ê With manual entry of the IP address: Owners of multiple steam sterilizers of the identical device type can differentiate between their devices by viewing serial number on the display to check whether MELAconnect has been connected to the correct device.
10 Settings Tap on a picture to select it. The white frame around the picture indicates which picture is currently selected. Repeated tapping on the picture selects/deselects it for the slide show. Ê The checkmark on the lower right-hand corner indicates whether the picture has been selected for the slide show.
10 Settings Sensitivity Select menu Settings > Touchscreen sensitivity. The display switches to the settings window. You can determine the pressure required to activate a pushbutton using the pushbuttons. Accept all the settings with SAVE and then leave the menu. Energy-saving mode If the steam sterilizer is not be switched off during longer operating pauses, it can be operated in energy- saving mode.
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10 Settings Switching off the display Optionally, you can choose whether the display is to be switched off when the steam sterilizer is in energy- saving mode (waiting time 2). Set the checkmark next to Activated and set the number of seconds after which the display is to be deactivated.
Do not use any hard objects for cleaning such as a metal saucepan cleaner or a steel brush. Sterilization chamber, chamber sealing face, mount, trays To maintain the value of your device and to avoid persistent contamination and deposits, MELAG recom- mends weekly cleaning of the surfaces (e.g. with the MELAG chamber cleaning set).
Checking and oiling the door lock NOTICE Wear of the door lock Only use MELAG oil. Check and oil the door lock every two months as follows: Clean the locking spindle and nut with a non-fuzzing cloth. Insert the test gauge into the door lock nut as far as it will go and turn it 180°.
11 Maintenance Maintenance NOTICE Continuing operation beyond the maintenance interval can result in malfunctions in the device. Maintenance should only be performed by trained and authorised service technicians or stockist technicians. Maintain the specified servicing intervals. Regular maintenance is vital to ensure reliable operation and value retention of the device. All function and safety-relevant components and electrical units must be checked during maintenance and replaced where necessary.
12 Pause times 12 Pause times Frequency of sterilization Pause times between the individual programs are not necessary, as the sterilization chamber is main- tained permanently at the same temperature. After the end/abort of the drying time and removal of the sterile material, you can load the steam sterilizer again and start a new program.
12 Pause times Emptying the double jacket You have the option of draining the water in the double jacket steam generator easily via program Drain. In order to do so, the steam sterilizer is heated once, building up pressure in the double jacket so that the wa- ter can be drained fully from the double jacket steam generator.
MELAG customer service. To enable us to give the best possible service, please have the serial number of your device, the malfunction number and a detailed description of the malfunction to hand.
Check whether the suction filter in the external water storage container is soiled or blocked and clean if necessary. When using a MELAG water treatment unit: c) Acknowledge the malfunction message c) Residual air is in the feed system of the...
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Empty and clean the container and fill it was used. with water of the required quality (EN 13060, Appendix C). When using a MELAG water treatment unit: When using a MELAG water treatment unit: b) MELAdem 40: The mixed-bed resin b) MELAdem 40: Replace the MELAdem 40 cartridge is exhausted..
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Check the door lock every two months c) The door spindle and/or the door lock nut (see Checking and oiling the door lock were not oiled regularly with the MELAG oil. [} page 65]). c) Oil the door lock nut regularly with the MELAG oil (see...
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13 Malfunctions Incident Possible causes What you can do The sterile filter is soiled/blocked. 1. Check whether the sterile filter suction aperture (centre aperture) on the rear panel of the steam sterilizer is blocked. If yes, replace the sterile filter. 2.
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13 Malfunctions Incident Possible causes What you can do a) The outlet hose is kinked or installed a) Check the installation of the outlet hose. sagging. This must be installed without kinking or b) The siphon is blocked or the waste water sagging and at a constant decline.
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13 Malfunctions Incident Possible causes What you can do The overheat control switch of the main 1. Switch off the steam sterilizer and press heating has tripped. This notification may be the reset button overheat control on the fore issued in alternation with E175: ACOUT 01 side of the steam sterilizer at the bottom right-hand side (behind the cover) back in.
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6. Transfer the log files on the CF card to a computer and re-format the CF card in the steam sterilizer. 7. The CF card is defective or incompatible. It is possible that a non-MELAG CF card has been used. Please note: We recommend using only original MELAG CF cards.
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1. Attempt to format the CF card on the c) The CF card is write-protected. computer. 2. The CF card is defective or incompatible. It is possible that a non-MELAG CF card has been used. Please note: We recommend using only original MELAG CF cards.
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13 Malfunctions Incident Possible causes What you can do The maximum operating interval or the Arrange for maintenance with an authorized number of batches since initial customer services/stockist technician. You commissioning or the last maintenance have can continue to operate the steam sterilizer been reached.
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13 Malfunctions Incident Possible causes What you can do a) The water inflow tap has not been opened a) Open the water inflow tap completely and or has been opened only insufficiently. check the central water inflow tap. b) The cold water inflow hose is kinked. b) Check the installation of the waste water c) The water supply in the practice is hose.
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13 Malfunctions Incident Possible causes What you can do a) The connection to the label printer has a) Check whether the power cable is been interrupted. connected to the socket and the Ethernet b) The label printer has not been switched cable of the label printer is correctly connected with the steam sterilizer.
14 Technical data 14 Technical data Device type Vacuklav 40 B+ Vacuklav 44 B+ Device dimensions (H x W x D) 56.5 x 46 x 58 cm 56.5 x 46 x 69 cm Empty weight 55 kg 64 kg Operating weight 66 kg 76 kg Sterilization chamber...
15 Accessories and spare parts 15 Accessories and spare parts You can obtain the specified articles and an overview of further accessories from your stockist. Category Article Art. no. Chamber Chamber depth depth 35 cm 45 cm Mounts Mount C "Plus" ME81370 ME81380 for 6 trays or 3 MELAstore Box 100 Mount D "Plus"...
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15 Accessories and spare parts Category Article Art. no. Spare parts Oil for door lock nut ME27515 Test gauge TR16 for door lock nut ME27522 Door seal ME45160...
Abb.: Deutsche Gesellschaft für Sterilgutverord- ployee of a customer service provider or stockist nung (German Association for the Sterilized Equip- who has been trained and authorised by MELAG ment Ordinance). The DSGV training centres are to perform maintenance and installation work on specified in DIN 58946, part 6 as “Requirements of...
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Glossary Network cable (crossover) a load; facilitating verification of the temperatures A crossover cable connects two computers maintained in comparison to the temperatures set. (through network cards) directly without the use of [see EN 13060] a hub/switch. This type of connection corresponds with the network connection of the steam sterilizer EN 13060 in the practice network.
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Glossary Solid Without hollows or gaps, solid, compact, closed Solid load Serves to prove that the necessary sterilization conditions have been reached within the entire load with the values set in the control. The load must represent the largest weight of massive in- struments designed for sterilization in a sterilizer in accordance with EN 13060.
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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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