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User Manual
Autoclave
Vacuklav
Vacuklav
Dear doctor,
We thank you for your confidence demonstrated by the purchase of this autoclave.
Over 55 years ago, MELAG began as a medium-sized family-run enterprise to specialise in the
manufacture of sterilization equipment for medical practices. In the meantime our company has grown
into one of the world's leading producers of sterilization equipment. Verification of it success has been
the sale of more than 410,000 MELAG units worldwide, attesting to the high quality of our sterilizers,
which are exclusively made in Germany.
This autoclave has also been manufactured and tested according to the most stringent quality criteria.
Nevertheless, please read the Operating Instructions carefully before the initial start-up of the device.
The long-term serviceability and the retention of value of your autoclave depend primarily on the
careful preparation of the instruments and the regular maintenance of the device.
MELAG - General Management and employees
®
41-B
®
43-B
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Summary of Contents for MELAG Vacuklab 41-B
- Page 1 In the meantime our company has grown into one of the world's leading producers of sterilization equipment. Verification of it success has been the sale of more than 410,000 MELAG units worldwide, attesting to the high quality of our sterilizers, which are exclusively made in Germany.
- Page 2 .Make sure to keep the User Manual near to the autoclave. The instructions are a part of the product. ® ® User Manual Vacuklav 41-B and Vacuklav 43-B MELAG Medical Technology Berlin ® ® Valid for Vacuklav 41-B, Vacuklav 43-B as of software version 2.4x...
- Page 3 Foreword Thank you for deciding to buy this premium class MELAG autoclave. ® This User Manual describes both the autoclaves Vacuklav 41-B and ® Vacuklav 43-B. They are identical except for their chamber depth and device depth. Device name The device name "autoclave" is used in this User Manual to designate the ®...
- Page 5 Check the pressure display of the manometer located on the generator autoclave lower front side. ■ Only have the autoclave set up, installed, and commissioned by Setting up, installation, people →authorized by MELAG. commissioning ■ Only operate the autoclave in areas which are not subject to explosion hazards. ■...
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Page 6: Table Of Contents
Safety instructions Contents Setting date and time..........34 Chapter 1 – Performance Specification....3 Determine format for program log files ....34 Proper use .............. 3 Reading log files correctly ........35 User benefit ............3 Finding logs ............37 Overview of sterilization programs...... -
Page 7: Chapter 1 - Performance Specification
Use the autoclave only for the intended purposes outlined in the related technical documents and only in connection with the devices Attention and components recommended by MELAG. ■ The sterilization of instruments and textiles with this autoclave, like the foregoing instrument sterilization, is only to be done by competent personnel. - Page 8 Chapter 1 – Performance Specification measurement. This prevents stains on instruments and soiling of the autoclave, assuming the instruments have been carefully prepared. Automatic feed water supply The supply with purified →feed water for the steam production is automatically provided from an internal supply tank or a water treatment ®...
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Page 9: Overview Of Sterilization Programs
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 Type B Type B Type S Type B Type B →DIN EN 13060 →Dynamic pressure test of the sterilization chamber →Air leak... -
Page 10: 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 autoclave contains what safety devices the autoclave has how the operating elements are designed and how you should use them how the menus of the user interface are structured which acoustical signals the autoclave emits what kind of water supply the autoclave needs... -
Page 11: Equipment Views
Chapter 2 – Device Description Equipment views Front view < Protective cap for slot of the →CF card Control panel Door (pivots 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 Draining hose covering of the supply tank Mains switch (concealed, accessible from the side) Ethernet-1 data connection*... -
Page 12: Effective Capacity
Chapter 2 – Device Description Interior view Chamber Mounting to hold the load Door spindle Threaded bushing Chamber sealing surface Door seal Door plate Figure 2: Interior view Effective capacity ® ® The autoclaves Vacuklav 41-B and Vacuklav 43-B differ only with respect to the respective depth of the units. -
Page 13: Switch On Autoclave
Chapter 2 – Device Description Switch on autoclave Observe the following precautionary measures when handling the mains cable and power plug: Danger ■ Never splice or modify the mains cable. ■ Never bend or twist the mains cable. ■ Never pull on the mains cable to take it out of the socket. Always take hold of the power plug itself. -
Page 14: Control Panel
Chapter 2 – Device Description Control panel The control panel consists of a display and four membrane keys. The →display can show 320 x 240 pixels. Key 1 – serves primarily for navigation Key 2 – serves primarily for navigation Key 3 –... - Page 15 Chapter 2 – Device Description Current operating situation Hot keys Function/explanation After the operator has terminated the Briefly simultaneously Opens the door after a program termination program press key 1 (see page 25, Manually terminate program) (CONFIRM) and key 3 (OPEN) DOCU Menu/Logging list Press each one of the...
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Page 16: Acoustical Signals
Chapter 2 – Device Description Error messages Error messages indicate an error or a malfunction. Reverse (selected) display You can only start programs or change settings if these are marked as selected, indicated by reverse display (highlighted). Example: not marked (normal display) marked (reverse display) Acoustical signals The autoclave emits acoustical signals. -
Page 17: Overview Of Menus And Symbols
Chapter 2 – Device Description Overview of menus and symbols Menus Symbols Main menu Universal-Program ├ Universal-Program ├ Quick-Program B Quick-Program B ├ Quick-Program S ├ Gentle-Program Quick-Program S ├ Prion-Program ├ SPECIAL menu Gentle-Program │ ├ Vacuum test │ ├... -
Page 18: Supply With Feed Water
Every MELAG autoclave can be supplemented with a water treatment unit. Please first consult with MELAG if you would like to use water treatment Notice units from other manufacturers. -
Page 19: Chapter 3 - Initial Commissioning
Conditions for setting up, installing and commissioning ■ Only have the autoclave 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. -
Page 20: Connections Required
Chapter 3 – Initial commissioning Space requirements Vacuklav®41-B Vacuklav®43-B Width A = 46 cm A = 46 cm Height B = 56 cm B = 56 cm Depth C = 58 cm C = 69 cm D = 25 cm D = 36 cm E = 21 cm E = 21 cm... -
Page 21: Prerequisites For Initial Commissioning
Chapter 3 – Initial commissioning In order to prevent water damage, MELAG recommends the use of a leak Notice monitor, e.g. a water stop valve from MELAG. Wastewater drain You can discharge the autoclave alternatively with the connection pressure release (see page 7,... -
Page 22: Chapter 4 - Sterilization
(see page 29, Plug in and remove CF card) Manufacturer's Observe the manufacturer's recommendations from MELAG on the routine recommendations for daily operation of Class B autoclaves. routine operation Prepare items to be sterilized A significant prerequisite for the secure disinfection and sterilization of →sterilizing materials is the appropriate cleaning and maintenance of the... - Page 23 When using the following devices, observe without fail the preparation instructions of the instrument manufacturer. To disinfect and clean the instruments, MELAG recommends the use of auxiliary materials such as: Ultrasonic units Maintenance appliances for hand and angle pieces...
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Page 24: Load The Autoclave
Notice 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. - Page 25 3 standard tray cassettes 6 kg 2 kg 7 kg 2.5 kg Maximum total weight * Tray mounts, trays, sterilization containers, standard tray cassettes from MELAG: see Appendix A - Accessories Table 10: Loading variants, example of mounting C, and maximum load...
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Page 26: Select Program
Chapter 4 – Sterilization Select program Select the desired program with the navigation keys in the main menu. Select the sterilization program accordingly, depending on how the →sterilizing materials are wrapped. Furthermore, consider the resistance to high temperature of the items to be sterilized. All sterilization programs are displayed in the main menu. -
Page 27: Start Program
That means that after completion of the program, the ´pre- selected start time is deleted ■ Unsupervised operation of electrical devices, including this autoclave at the operator’s risk. MELAG accepts no liability what so ever for any Warning damage resulting from unsupervised operation. Start program If you have selected a program with the navigation keys, it is displayed marked (inversely highlighted). - Page 28 Chapter 4 – Sterilization By pressing the DETAILS button you can have additional information on the ongoing program provided on the →display. By repeated long pressing of the DETAILS button, this information is once again hidden. Follow the programme run on You can follow the current progress of a current sterilization programme in the computer a web browser on every computer of the user network via the website...
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Page 29: Sterilization Phase Is Finished
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 termination. -
Page 30: Drying Phase
Chapter 4 – Sterilization Drying phase The autoclave does an excellent job of drying the items to be sterilized. In the event of difficult drying tasks it might however be necessary to take the following measures to further improve drying: Load the autoclave correctly for drying. -
Page 31: Storage Of Sterilized Items
Chapter 4 – Sterilization ■ Check the wrapping of the sterilized objects for damage when removing them from the autoclave. ■ If a wrapping is damaged, wrap the object again and re-sterilize it. Danger Non-observance can result in unsterile instruments. This endangers the health of the patient and the practice team. -
Page 32: 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 How to read the logs correctly How to set the date and time at the autoclave Batch documentation The batch documentation is indispensable as documentation for the... -
Page 33: Plug In And Remove Cf Card
Notice it is recommended that you use only MELAflash CF cards with a memory capacity of 1GB or more from MELAG. These are despatched in a certified and formatted state. It is well-known that some older CF cards with 256 MB memory capacity can cause file system problems (e.g. - Page 34 Chapter 5 – Logging Push the protective cover as far as possible to the right until the card slot is freely accessible. Card slot for CF card Protective cover Figure 7: Protective cover for card slot to the right Use the CF card with the palpable grip edge facing left in the card slot.
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Page 35: Automatic Immediate Log Output
It provides the option of issuing this log at the next possible time. MELAG recommends using the Automatic logging with immediate output of the logs (corresponding to the state of delivery). -
Page 36: Subsequent Output Of Stored Logs
Chapter 5 – Logging Subsequent output of stored logs With the DOCU Menu you have the possibility of subsequently outputting logs independent of the time of a program end. You can employ activated output media or another output medium for automatic logging in the SETUP menu. -
Page 37: Use Log Printer As Output Medium
Chapter 5 – Logging In the selection list, go to the menu item All program logs. Press SELECT. Press OUTPUT. At the →display the notification Log output is shown and the →LED to the right next to the card slot lights up. For the output of a log record onto the CF card, the autoclave requires about four seconds. -
Page 38: Using The Pc As Output Medium
Chapter 5 – Logging Plug the power supply (1) into the wall socket. Connect the →MELAG network adapter (3) with the supplied cable (2) to an Ethernet data connection point of the autoclave (see page 7, Figure 1/. (13)) Plug the →MELAG network adapter (3) into the serial connection of ®... -
Page 39: Reading Log Files Correctly
Chapter 5 – Logging Standard format 0002 The medium logging format 0002 is the standard format. You determine the print formats for the program log files in the SETUP menu under the menu item Automatic logging – Logging format. Logging format Component 0000 0001 0002 Header... - Page 40 A000000500A7018953C9030704D6043231A43490 >> Proof of veracity batch log files << was created and not changed on an autoclave from MELAG Table 15: Example of a program listing for a successfully concluded Quick-Program B Log types Apart from log files for successfully concluded programs, there are diverse other log types.
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Page 41: Finding Logs
Chapter 5 – Logging Extensio Stands for Explanation Program log file Log of a successfully concluded program Graphic log Log in which the sterilization processes are recorded graphically Fault log Log of a terminated program Error in standby Log of errors without a program running System log Listing of all errors and modifications of the system that occurred in temporal sequence (logbook) -
Page 42: Chapter 6 - Maintenance
Chapter 6 – Maintenance In this chapter you learn How to clean the autoclave and which cleaning agents are suitable How to avoid the formation of spots Which feed water to use How to oil the door spindle What you must observe for the autoclave maintenance Cleaning Weekly inspection of Examine the chamber including the door seal and chamber sealing... -
Page 43: Avoid Formation Of Spots
Chapter 6 – Maintenance perceptibly engages Drain off the water into a container with at least 5 litres holding capacity. To remove the drain hose again, press the grey release knob at the quick-fitting connection. The hose detaches itself automatically from the connection. -
Page 44: Oil Door Spindle
Maintenance ■ Have maintenance carried out only by trained field service technicians 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. Non-observance can lead to damage of the autoclave and to serious injury to health. -
Page 45: Chapter 7 - Operating Pauses
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 autoclave. You can save energy this way. -
Page 46: Decommissioning
Chapter 7 – Operating pauses Modify the respective values for waiting time 1 or waiting time 2 via the navigation keys. Longer operating pauses Switch the autoclave off for longer operating pauses, e.g. overnight or on the weekend, and leave the door ajar. The door seal is thus relieved and protected from premature fatigue. -
Page 47: Re-Commissioning After Change Of Locality
Chapter 7 – Operating pauses ■ Before you move the autoclave, wait after switching off the power until the manometer for the pressure display of the →double jacket steam Attention generator (page 7, 1/(4)) shows zero bar. Figure ■ Close the water feed and remove the hose connections at the rear of the device. -
Page 48: Chapter 8 - Function Test
(see page 28, Chapter 5 – Logging). Testing in daily operation Observe the manufacturer's recommendation from MELAG on the routine operations of Class B autoclaves according to the recommendations of the Robert Koch Institute from April 2006. Notice... -
Page 49: Bowie & Dick Test
Chapter 8 – Function test In case of a respective error (e.g. in the vacuum system) The test serves to determine leaks in the autoclave. The leakage rate is determined. Conduct the vacuum test with a cold and dry autoclave as follows: Turn the mains switch on to power the autoclave (page 7, Figure 1/ (7). -
Page 50: Chapter 9 - Errors
Chapter 9 – 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 A warning is not an error Not all messages which appear on the →display are error messages. -
Page 51: Before You Call
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 autoclave and a detailed fault description in readiness. - Page 52 Chapter 9 – Errors Event Possible causes What you can do FUN1 Autoclave was switched off while a Do not switch off autoclave at the mains program was running switch while a program is running Power connection not completely made Check building-side installation, operate Power plug was withdrawn autoclave on a separate electric circuit.
- Page 53 Repeat vacuum test if autoclave is cold, dry chamber or with load and empty WART Two years have elapsed since the initial Call MELAG customer service or specialist commissioning or since the last dealers and make a maintenance maintenance or 3000 sterilization programs appointment;...
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Page 54: Bad Drying Results
Chapter 9 – Errors Event Possible causes What you can do Autoclave is overloaded observe the maximum loads; use insert frame; Please ensure sufficient air feed to Surrounding temperature is too high, the autoclave rear panel, check for Autoclave is installed and is receiving no or packaging residue in the chamber. -
Page 55: Glossary
DGSV Technicians from depots or employees from service Deutsche Gesellschaft für Sterilgutverordnung (German companies designated by MELAG that are trained by Association for Sterile Material Directive); the training MELAG guidelines of the DGSV are listed in DIN 58946, Part 6 as "Personnel Requirements"... - Page 56 MELAG Ethernet adapter load; permits checking the maintained temperatures and pressures with respect to the intended settings Ethernet printer module for the MELAG printer ® [→DIN EN 13060] MELAprint ; the printer connection is located on one...
- Page 57 Glossary Solid Without hollows or spaces; firm, dense, closed Solid load – check of solid load Serves to verify that for the values set on the control, the required sterilization conditions were achieved within the entire load. The load must represent the maximum measurements of solid instruments for whose sterilization a sterilizer has been designed according to →DIN EN 13060...
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Page 58: Appendix A - Accessories
® MELAdem 47 reverse-osmosis system 01047 For the Documentation MELAflash CF card 01043 CF card reader MELAflash 01048 ® 01042 MELAprint 42 log printer MELAG Ethernet adapter for use of 40295 ® MELAprint Water stop valve Water stop valve 01056... -
Page 59: Appendix B - Symbols On The Autoclave
Appendix B - Symbols on the autoclave Appendix B – Symbols on the autoclave The manufacturer of the apparatus declares with the accompanying sticker that the medical device corresponds to the basic requirements of the European Standard EN1717 – "Protection of drinking water from contaminants…."...
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