MELAG Vacuklav 41 B+ Evolution User Manual
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MELAG Vacuklav 41 B+ Evolution User Manual

Steam sterilizer
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User Manual
Vacuklav 41 B+ Evolution
Vacuklav 43 B+ Evolution
Steam sterilizer
as of software version v3.218
EN
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
hygiene"
and
"Quality – made in
management system in accordance with ISO 13485 and ISO 9001 is subject to close monitoring e.g. through our annual
multi-day audit conducted conducted by a specified independent certification agency. This guarantees that all MELAG
products are manufactured and tested in accordance with strict quality criteria.
The MELAG management and team.
Germany", we guarantee that these demands will be met. Our certified quality
"competence in

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Summary of Contents for MELAG Vacuklav 41 B+ Evolution

  • Page 1 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.

  • Page 3: Table Of Contents

    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 .............................. 9 Safety equipment ................................. 9 Overview of sterilization programs (class B) ........................ 11 Program sequences ................................ 12 4 Description of the device.............................. 13 Scope of delivery................................ 13...
  • Page 4 Contents 9 Functional checks ................................ 40 Vacuum test .................................. 40 Bowie & Dick test ................................ 41 10 Settings ..................................... 42 Logging .................................... 42 User administration ................................ 46 Formatting the CF card .............................. 48 Additional drying................................. 48 Intelligent drying ................................. 49 Water supply .................................. 49 Date & time .................................. 50 Brightness .................................. 50 Volume .................................... 51 Key tone ..................................... 51 Screensaver .................................. 52...

  • Page 5: General Guidelines

    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.
  • Page 6 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...

  • Page 7: Safety

    Check the device for any damage suffered during transport after unpacking. Only have the device set up, installed, and started up by people authorized by MELAG. The connections for electrical provision and water supply and discharge must be set-up by trained per- sonnel.
  • Page 8 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.

  • Page 9: Performance Specifications

    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 DIN EN 13060, this steam sterilizer is a Class B sterilizer. As a universal steam sterilizer, it is suited to highly-demanding sterilization tasks.
  • Page 10 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. Automatic emergency shutdown The steam sterilizer is equipped with an emergency shut-down mechanism;...

  • Page 11: Overview Of Sterilization Programs (Class B)

    3 Performance specifications Overview of sterilization programs (class B) The results in this table show which inspections were performed on the steam sterilizer. The marked field shows compliance with all the applicable sections of the standard DIN EN 13060. Type tests Universal- Quick- Quick-...

  • Page 12: Program Sequences

    3 Performance specifications Program sequences Regular sterilization program A program runs in three phases, the air removal; sterilization; and 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 / the drying.

  • Page 13: Description Of The Device

    4 Description of the device 4 Description of the device Scope of delivery Standard scope of delivery ▪ Vacuklav 41 B+ or Vacuklav 43 B+ ▪ User manual ▪ Usage instructions for the mounts ▪ Manufacturer's inspection report including declarations of conformity ▪...

  • Page 14: Views Of The Device

    4 Description of the device Views of the device Tank lid of the internal storage tank 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*) Power switch (covered, accessible from the side) Ethernet connection Overheat control reset button...

  • Page 15: Energy-Saving Key

    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 Energy-saving key Pressing the energy-saving key activates the energy-saving mode and switches off the display. The double jacket will not be heated until the next program start.

  • Page 16: Colour-Touch Display

    4 Description of the device A spring clip is located on the rear panel of the sterilization chamber to fix the mount. When using a “Plus” mount, slide the mount into the sterilization chamber to its fullest extent, until the mount snaps into the spring clip.

  • Page 17: Led Status Bar

    4 Description of the device Symbol in the menu bar Meaning Program/tests Lists all sterilization programs and tests e.g. Vacuum test, Bowie & Dick- test etc. Log output Here you can display the entire log list or the list of logs from a restricted time e.g.

  • Page 18: First Steps

    The responsible stockist is to complete the record of installation and setup as proof of the correct setup, installation and commissioning. A copy is to be sent to MELAG Medizintechnik oHG and the stockist. This is a constituent part of any guarantee claim.

  • Page 19: Switching On The Steam Sterilizer

    5 First steps Switching on the steam sterilizer ü The steam sterilizer is connected to the electricity supply. ü The feed water supply is secure. The steam sterilizer requires c. 3 L feed water for the first filling of the steam generator.
  • Page 20 5 First steps 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. The door is locked pressure-tight upon program start. When closing the door, comply with the following instructions to guarantee faultless operation of the door locking mechanism: Do not exert too little pressure when pushing the door closed.

  • Page 21: Loading The Steam Sterilizer

    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.

  • Page 22: Loading The Steam Sterilizer

    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.
  • Page 23 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. Do not place multiple soft sterilization packages flat on top of each other on a tray or in a container.

  • Page 24: Sterilization

    (see above). The use of another test system in accordance with DIN 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. The indicator test strips used need not be stored.

  • Page 25: Selecting The Program

    7 Sterilization Selecting the program 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. All sterilization and additional programs are displayed in the Programs & Tests menu. The following table shows which sterilization material fits which program and which additional programs are available.

  • Page 26: Additional Program Options

    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- selection is only active for the unique time and program selection.

  • Page 27: Starting The Program

    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...

  • Page 28: Manual Program Abort

    7 Sterilization The sterilization phase is unsuccessful if the operator or the system (responding to a fault) aborts the program run. A system abort returns the steam sterilizer to a pressureless state. This explains why a system abort takes longer as an abort by the operator. Drying phase The steam sterilizer provides excellent drying of the sterilization material.
  • Page 29 7 Sterilization Program abort before the start of drying WARNING Danger of infection from early program abort Aborting a program before the drying phase begins means that the load is unsterile. This endangers the health of your patients and practice team. If necessary, repack the load and repeat the sterilization for the sterilization material af- fected.

  • Page 30: Program End

    7 Sterilization Proceed as follows to abort the program during drying: Press STOP on the action bar. 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. Working in the Settings menu → Logging if immediate output after program end is activated, (= Immediate output), the log of the completed program will be outputted to the activated output medium after opening the door.

  • Page 31: Removing The Sterilized Equipment

    7 Sterilization The approval process According to RKI "Hygiene requirements for the treatment of medical products", instrument treatment ends with the documented approval for storage and application of the sterilized equipment. The approval process consists of batch indication and batch approval and must be performed by authorized and expert personnel.

  • Page 32: Storing Sterile Instruments

    7 Sterilization Storing sterile instruments The maximum storage time is dependent on the packaging and the storage conditions. For standard- conform packaged sterilized equipment – (if protected from dust) it can amount to up to six months. Comply with the provisions of DIN 58953, part 8 and the criteria specified below for the storage of sterilized equipment: Comply with the maximum storage duration in accordance with the packaging type.

  • Page 33: Logging

    8 Logging 8 Logging Batch documentation The batch documentation acts as proof of the successful conclusion of the sterilization process and represents an obligatory part of quality control. The data, such as type of program as well as batch and process parameters of the completed programs, are stored in an internal log memory of the device.
  • Page 34 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.

  • Page 35: Outputting Text Logs Automatically After Program End (Immediate Output)

    8 Logging Select "Select a program from a list of installed programs" and confirm with "OK". You can then open files with this ending via a double-click in Windows Editor. Using the label printer as an output medium The use of a label printer facilitates batch traceability. Using the sterilization date, the storage duration, batch number, user ID of the person approving the application for use, the steam sterilizer used and the file name it is possible to assign the sterilized instruments to the patient and sterilization batch.

  • Page 36: Subsequent Log Output

    8 Logging Information regarding the setting of immediate output and the desired output medium is provided in the chapter Settings, logging [} page 42]. Subsequent log output The Log output menu provides the option of outputting text logs subsequently and independently of the point of the program end.
  • Page 37 8 Logging A list with all text logs is displayed which have been saved in the internal memory. To ease the search, you can filter the log sort sequence by date, program or event by selecting the top line. Select a log and press CONTINUE. Select an output medium and press OUTPUT.

  • Page 38: Finding A Log

    When transferring the logs to a CF card, they will be stored in a separate folder in the main directory. Direct transfer of the log 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.
  • Page 39 << 010041D8BE14B1319E55772A0DF975054F7EBF32 Proof of authenticity (electronic signature)
Should never EE1372767ED3B3801EB10F3FB01A3212D41D7144 be altered; decoding the code (by MELAG) indicates 1C3B8B6474777962766F018680B68C56C219074F whether the data was generated on a MELAG steam D6E7814D506F0A2F3077782541CC2CD05C425DA1 sterilizer and has been changed. 9A5EF5192C68174C868556542F7B8B05E97C6E46 16CDCFFA811E126FD67363FB74128A5F83AE6F37 F45A9E240C88615F1618D340060C1027205C83C2 >>Authentication of batch log<<...

  • Page 40: Functional Checks

    9 Functional checks 9 Functional checks PLEASE NOTICE Please comply with the recommendations issued by the Robert-Koch-Institute (RKI) and DIN 58946-7. 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.

  • Page 41: Bowie & Dick Test

    9 Functional checks Bowie & Dick test The Bowie & Dick test serves as the 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 the Bowie & Dick test program to this end.

  • Page 42: Settings

    10 Settings 10 Settings Logging All settings pertaining to the output of text and graphic logs i.e. output medium, log format, immediate output etc. are performed in the Settings menu → 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 card is activated immediately after the program end.
  • Page 43 10 Settings If you wish to output a graphic log (optional) in addition to a text log, proceed as follows: ü Navigate to Settings → Logging. ü Immediate output is activated. Set a checkmark next to the Graphic logs option and check whether the checkmark is also set next to the Immediate output option.
  • Page 44 10 Settings Using the computer as an output medium Log transmission can be performed via an FTP server / service or TCP. The following section shows how to set the desired connection: ü Navigate to the Settings → Logging menu. ü The steam sterilizer is connected to a computer via a network cable (RJ45). ü...
  • Page 45 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).

  • Page 46: User Administration

    10 Settings 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.
  • Page 47 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 and then leave the menu.

  • Page 48: Formatting The Cf Card

    10 Settings Changing the Admin PIN PLEASE NOTICE 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 delivery. Formatting the CF card NOTICE All data saved on the CF card is deleted during formatting.

  • Page 49: Intelligent Drying

    10 Settings Confirm with SAVE. 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 residual moisture in the sterilization chamber. A number of factors play a role in this process including e.g. the nature of the load, wrapped or unwrapped, the load quantity, the distribution of the load in the sterilization chamber etc.

  • Page 50: Date & Time

    10 Settings Date & time Correct batch documentation requires the correct date and time setting on the steam sterilizer. Ensure that you take into account the clock change in autumn and summer, as this is not adjusted automatically. Once the time has been set on the steam sterilizer, it is very accurate. Set the date and time as follows: Select Settings → Date &...

  • Page 51: Volume

    10 Settings Volume Select Settings → Volume. The display switches to the settings window. Press the pushbutton to adjust the volume. Accept all the settings with SAVE and then leave the menu. Key tone Select Settings → Key tone. The display switches to the settings window. Press YES or NO to determine whether a tone should be emitted every time a pushbutton is pressed.

  • Page 52: Screensaver

    10 Settings Screensaver A screensaver can be activated to protect the display in standby operation. This displays a continuous slide show of any pictures. Select images for the slide show Select Settings → Screensaver . The display switches to the settings window. Tap on a picture to select it.

  • Page 53: Log Printer Melaprint 42

    10 Settings Log printer MELAprint 42 If you wish to output the sterilization log via the log printer MELAprint 42, you need to set this on the steam sterilizer once. The operating manual of the log printer indicates how to set it up. Label printer MELAprint 60 If you wish to output the sterilization logs via the label printer MELAprint 60, you need to set this on the steam sterilizer once.
  • Page 54 10 Settings Select Waiting time 1 directly by touching the time. The area is displayed light blue. Change the minutes using the pushbuttons. Repeat the step for waiting time 2. Press CONTINUE. 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: The double jacket will not be heated until the next program start.

  • Page 55: Maintenance

    11 Maintenance 11 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 With every filling of the Check the storage tank for Internal storage tank storage tank soiling and clean it if necessary before filling...
  • Page 56 11 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, clean the storage tank with fresh feed water before filling.

  • Page 57: Avoiding Staining

    11 Maintenance Cleaning the feed and waste water side You can remove the cover of the storage tank completely to clean the chambers of the internal storage tank. Remove the fore tank lid. Grasp the cover on the filling opening and then lift the cover upwards a little.

  • Page 58: Maintenance

    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 authorized customer services techni- cians, or stockist technicians. Maintain the specified servicing intervals. Regular maintenance is vital to ensure reliable operation and value retention of the steam sterilizer. All function and safety-relevant components and electrical units must be checked during maintenance and replaced where necessary.

  • Page 59: Pause Times

    12 Pause times 12 Pause times Frequency of sterilization Pause times between the individual programs are not necessary, as the sterilization chamber is maintained permanently at the same temperature. 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.

  • Page 60: Transport

    12 Pause times Transport CAUTION Danger of injury from incorrect carrying. Lifting and carrying too heavy a load can result in spinal injury. Failure to comply with these provisions can result in crushing. The device should always be carried by two people. Use the suitable carrying straps to carry the device.

  • Page 61: Recommissioning After Relocation

    12 Pause times Transport over long-distance / dispatch For transport over longer distances, during the danger of frost and / for despatch or during maintenance, an authorized person must prepare the steam sterilizer according to instructions and empty the double- jacket steam generator entirely.

  • Page 62: Malfunctions

    Should you be unable to find the relevant event in the table below, or your efforts do not redress the problem, you can contact your nearest stockist or an authorized MELAG customer service provider. To enable us to give the best possible service, please have your steam sterilizer serial number and a detailed description of the fault to hand.

  • Page 63: Warnings

    13 Malfunctions Warnings Incident Possible causes What you can do With an internal storage tank for feed Empty and clean the storage tank and fill with feed water: water of insufficient quality was water of sufficient quality poured into the storage container (>60 µS/cm) With a water quality: With a water treatment unit: mixed-bed Replace the mixed-bed resin in the water treatment...
  • Page 64 13 Malfunctions Incident Possible causes What you can do F102 See W128 F113 Steam sterilizer switched off during a Do not switch off the steam sterilizer at the power running program switch whilst a program is running The power plug has been disconnected, Check the power plug and building power plug;...

  • Page 65: Technical Data

    14 Technical data 14 Technical data Device type Vacuklav 41 B+ Evolution Vacuklav 43 B+ Evolution Device dimensions (HxWxD) 56.5 x 47 x 57.5 cm 56.5 x 47 x 69 cm Chamber diameter/depth Ø 25 cm | 35 cm Ø 25 cm | 45 cm Chamber volume 18.4 litres...

  • Page 66: Accessories And Spare Parts

    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 Order no. Mounts Mount C "Plus" 81375 81385 for 6 trays or 3 MELAstore-Boxes 100 Mount D "Plus"...

  • Page 67: Glossary

    Authorized personnel An authorized personnel can be medical stockists, DIN 58946-7 depot technicians or MELAG-authorized customer Standard – sterilization - steam steam sterilizers - services trained by MELAG. part 7: Building requirements and requirements placed on the operating agents and the operation...
  • Page 68 See simple hollow body 10 and D ≥ 5; L…hollow body article length; D… hollow body article diameter [see also DIN EN MELAG network adapter 13060] Ethernet printer module for the MELAprint 42 log printer; a printer connection on one side and a net-...
  • Page 69 Glossary 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 DIN EN 13060.
  • Page 70 MELAG Medizintechnik oHG Geneststraße 6-10 10829 Berlin Germany E-Mail: 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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Vacuklav 43 b+ evolution

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