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User Manual

Vacuklav

®

 40 B+ 

Evolution

Vacuklav

®

 44 B+ 

Evolution

Steam sterilizer

from software version 3.240

EN

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. Our focus on innovation, quality and the highest standards of operational reliability has established MELAG
as the world’s leading manufacturer in the instrument reprocessing and hygiene field.

You, our customer are justified in your demand for the best products, quality and reliability. Providing 

“competence in

hygiene”

 and 

“Quality – made in Germany”

, we guarantee that these demands will be met. Our certified quality man-

agement system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in ac-
cordance with EN ISO 13485. This guarantees that all MELAG products are manufactured and tested in accordance with
strict quality criteria.

The MELAG management and team.

Summary of Contents for Vacuklav 40 B+ Evolution

Page 1: ...al reliability has established MELAG as the world s leading manufacturer in the instrument reprocessing and hygiene field You our customer are justified in your demand for the best products quality an...

Page 2: ......

Page 3: ...vice 14 Load mounts 15 Energy saving key 16 Colour touch display 16 LED status bar 18 5 First steps 19 Setup and installation 19 Feed water supply 19 Supply with cooling water 19 Switching on the stea...

Page 4: ...Screensaver 60 Log printer MELAprint 42 44 61 Label printer MELAprint 60 61 Sensitivity 62 Energy saving mode 62 11 Maintenance 64 Servicing intervals 64 Cleaning 64 Avoiding staining 65 Checking and...

Page 5: ...following functions Accessing the device status and program progress Accessing the user manuals and video tutorials for using the device Locating malfunctions and accessing solutions and assistance im...

Page 6: ...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 provi...

Page 7: ...eived for use outside the patient area The device should be located a minimum of 1 5 m radius away from the treatment area n The documentation media computer CF card reader etc must be placed in such...

Page 8: ...pack the load and re sterilize it Transport and storage n Store and transport the device in a frost free environment n The device should always be carried by two people n Use suitable carrying straps...

Page 9: ...ment cavities This permits the sterilization of large quantities of instruments or tex tiles directly one after each other thereby achieving excellent drying results Type of the feed water supply The...

Page 10: ...tests Universal Program Quick Program B Quick Program S Gentle Program Prion Program Program type in accordance with EN 13060 Type B Type B Type S Type B Type B Dynamic pressure test of the sterilizat...

Page 11: ...izing If the pressure and temperature correspond to the program dependent nominal values the sterilization phase begins The corresponding process parameters pressure and temperature are held at steril...

Page 12: ...ies for small steam sterilizers Manufacturer s inspection report and declaration of conformity Warranty certificate Technical manual Record of installation and setup Tray lifter Power cable 4x cover c...

Page 13: ...rgency 13 Front device foot adjustable 14 Manometer for pressure display on the double jacket steam generator behind cover 23 24 25 22 18 16 17 21 15 20 19 27 26 Fig 2 View from rear 15 Ethernet conne...

Page 14: ...rvice hatch The service hatch is opened by pressing on the recess The service hatch is closed again by closing and pressing on the recess Fig 4 Opening and closing the service hatch Symbols on the dev...

Page 15: ...ce may not be disposed as domestic waste The vendor is responsible for appropriate disposal of the device it must be delivered to the vendor to be disposed of MELAG devices are synonymous for long ter...

Page 16: ...ivated during a program run State Meaning Lighted The energy saving mode can be activated Not lighted The energy saving mode can not be activated Colour touch display The operating panel consists of a...

Page 17: ...fo status window Displays information regarding the software version and device data e g total number of batches maintenance counter log settings log memory and further technical values Service area O...

Page 18: ...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...

Page 19: ...of feed water is sufficient for up to 25 steriliza tion runs Fill the storage container with feed water The water level of the storage container may not fall below the MIN mark during operation Check...

Page 20: ...on the device type it requires a heat up time of approx 9 13 min after being switched on This time is required for the pre heating of the double jacket steam generator Opening and closing the door Th...

Page 21: ...the door closed for min 3 s until the door lock engages Manual door emergency opening CAUTION Danger of scalding from hot steam Hot steam egress from the sterilization chamber is possible e g if it is...

Page 22: ...y 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 4 Turn the Allen key to open the door in a clockwise di...

Page 23: ...gents Do not use any water repellent agents or oils impermeable to steam u When using ultrasonic devices care equipment for handpieces and washer disinfectors comply with the manufacturer s reprocessi...

Page 24: ...packaging is important in achieving successful sterilization results You can use re usable rigid packaging systems or soft packaging such as transparent sterilization packaging paper bags sterilizati...

Page 25: ...the seam seal tears during sterilization this could be caused by the choice of undersized packaging Re pack the instruments with larger packaging and perform sterilization again u Should the seam sea...

Page 26: ...efore starting work the steam sterilizer must be cold and dry Batch related tests With Critical B instruments MELAcontrol Helix MELAcontrol Pro must be used as batch control with every sterilization c...

Page 27: ...ter connection is present and the mains voltage Drying Activation of the intelligent drying subjects the drying phase to automatic managing and ends as soon as the load is dry Program name Packaging E...

Page 28: ...ram see Additional drying page 55 Start time pre selection NOTICE Unsupervised operation of electrical devices including this steam sterilizer at the operator s risk MELAG accepts no liability what so...

Page 29: ...rogram the door closes pressure tight and the steam sterilizer checks the quantity of feed water and its conductivity 1 To start a program press the START key 2 With activated user authentication Ente...

Page 30: ...or or the system responding to an malfunction aborts the program run A system abort returns the steam sterilizer to a pressureless state This explains why a system abort takes longer than an abort by...

Page 31: ...This could result in scalding n Use a tray lifter to remove the tray n Never touch the sterile material the sterilization chamber or the door with unprotected hands The components are hot Program abo...

Page 32: ...d successful ly The steam sterilizer issues a malfunction message You then need to expect insufficient drying espe cially in the case of wrapped sterile material and a full load Sterile storage requir...

Page 33: ...menu the log of the completed program will be outputted to the activated output medium after opening the door The approval process See also Approving the sterilization batch Video tutorial According...

Page 34: ...team n Should the packaging be damaged or have burst after sterilization wrap the load again and re sterilize it If you remove the sterile material from the device directly after the end of the progra...

Page 35: ...wing listed criteria u Comply with the maximum storage duration in accordance with the packaging type Comply with the manufacturer s information on the packaging u Do not store the sterile material in...

Page 36: ...e is displayed Internal log memory full You now have the last chance to archive logs which have not been outputted confirm query with YES before the data in the steam sterilizer log memory up to the l...

Page 37: ...ation pertaining to the requirements and setting of the computer as an output medium is available in the chapter Settings logging page 45 Reading out a text log on the computer All text logs can be op...

Page 38: ...arked with a label to a specific batch the sterilization log file name must not be changed Type serial number Sterilization date Storage duration Daily batches no total batches User ID File name Stora...

Page 39: ...ending Explanation Last log PRO The log of the last successful completed program is outputted Logs of the day PRO The log of the last successful program of the current day is outputted Logs of the we...

Page 40: ...s that have been saved in the internal memory To facilitate the search you can filter the log sorting sequence by date program or outcome by selecting the top line 3 Select a log and press CONTINUE 4...

Page 41: ...be saved Log directory A folder is created on all memory media CF card or computer after log output containing the encoded se rial number of the steam sterilizer concerned The folder name consists of...

Page 42: ...5DA1 9A5EF5192C68174C868556542F7B8B05E97C6E46 16CDCFFA811E126FD67363FB74128A5F83AE6F37 F45A9E240C88615F1618D340060C1027205C83C2 Authentication of batch log 0 00 0 0 0 0 0 0 0 0 edk etm etd etp etv ett...

Page 43: ...cumstances Once a week in routine operation During commissioning Following longer operating pauses Following a malfunction e g in the vacuum system Perform the Vacuum test with the steam sterilizer in...

Page 44: ...chamber of the steam sterilizer and close the door 3 Working in menu Programs Tests select Bowie Dick test and press START Evaluation of the indicator following the colour change Depending on the manu...

Page 45: ...ut is not to be performed immediately following the end of a program but saved in the internal memory e g to be collected and outputted together within a single week you can deactivate the immedi ate...

Page 46: ...o Immediate output 2 Press CONTINUE and select the CF card and or the computer as the output medium 3 If necessary change the intervals and press CONTINUE 4 Working in this window check whether at lea...

Page 47: ...d Log output in English If you want to print all text logs on the MELAprint log printer in English proceed as follows The text log is to be printed in English regardless of the language of the graphic...

Page 48: ...fected via FTP or TCP Connection via FTP An FTP server or an FTP service is installed on the computer 1 Select Connection via FTP The lower pushbutton displays the current user data settings standard...

Page 49: ...f the network technology Errors in the handling of IP addresses can result in malfunctions and data loss in your practice network n IP addresses may only be set by the practice network system administ...

Page 50: ...2 Working in the logging assistant navigate to the window in which the IP addresses of the individual devices are listed 3 Select e g the steam sterilizer autoclave The settings window opens 4 Select...

Page 51: ...inistration An ID and individual user PIN can be issued to every user with which to authenticate him herself so as to enable reliable traceability via the clearance process You can determine the neces...

Page 52: ...e settings with SAVE then leave the menu 7 Exit the menu by pressing this symbol Deleting a user 1 Select the User administration option as described above and open the user list 2 Select the user ID...

Page 53: ...uthentication upon program start Query user authentication upon program end Query user authentication upon program start and end You can skip the query user authentication Determining options for the...

Page 54: ...start or after program end Press the key to skip the user authentication 6 Accept all the settings with SAVE then leave the menu Formatting the CF card NOTICE All data saved on the CF card is deleted...

Page 55: ...s to the settings window 2 Press pushbutton YES or NO to choose whether additional drying should be performed during all subsequent program runs 3 Confirm with SAVE Activating deactivating additional...

Page 56: ...ligent drying The display switches to the corresponding window 2 If you wish to deactivate intelligent drying select NO 3 Confirm with SAVE Date and time Correct batch documentation requires the corre...

Page 57: ...pushbutton or to adjust the brightness and contrast on the display 3 Accept all the settings with SAVE and then leave the menu Volume 1 Select menu Settings Volume The display switches to the setting...

Page 58: ...ings window 2 Press the CLASSIC button The design changes immediately 3 Press CONTINUE 4 Tap on a colour box to change the background colour e g blue The background colour changes immediately and the...

Page 59: ...utomatically 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 follow...

Page 60: ...e display to check whether MELAconnect has been connected to the correct device Key tone 1 Select menu Settings Key tone The display switches to the settings window 2 Press YES or NO to determine whet...

Page 61: ...ttons 3 Confirm the settings with SAVE The display switches automatically to the Settings menu Explanation of the slide show options Display duration per picture indicates the time in seconds between...

Page 62: ...et waiting time of 15 min the temperature of the double jacket steam generator falls to 103 C The program run time increases by approx 2 min upon the next start Waiting time 2 W2 After a pre set waiti...

Page 63: ...steam sterilizer is in energy saving mode waiting time 2 1 Set the checkmark next to Activated and set the number of seconds after which the display is to be deactivated 2 Confirm the settings with SA...

Page 64: ...om mends weekly cleaning of the surfaces e g with the MELAG chamber cleaning set Cleaning the sterilization chamber chamber sealing face mount and trays The following must be fulfilled or present The...

Page 65: ...s and in the sterilization chamber as deposits and stains All steam conducting parts of the device consist of non rusting material This rules out the possibility of stain or rust development being cau...

Page 66: ...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...

Page 67: ...night or the weekend Open the door and switch off the steam sterilizer Leave the door ajar to prevent premature wear and the sticking of the door seal Longer than two weeks Perform a vacuum test Afte...

Page 68: ...e carried by two people n Use the correct carrying straps to carry the device Transport within the practice Comply with the following provisions during transport within a room or the practice u Decomm...

Page 69: ...nd practice team n Re pack the load if necessary n Repeat the sterilization of the load All messages with current descriptions can be found in the Troubleshooting portal on the MELAG website https www...

Page 70: ...the pressure tank is sufficiently full with water e Check whether the water inflow tap for the water treatment unit is open When using a MELAdem 47 check whether the tap on the pressure tank is open W...

Page 71: ...or sagging and at a constant decline b Check whether the building siphon is blocked Please note If multiple devices are operated simultaneously we recommend the installation of an additional siphon c...

Page 72: ...emergency opening page 21 clean the door seal and the seal face on the sterilization chamber see Cleaning page 64 83 The door does not reach a pressure tight state after the program start a The door s...

Page 73: ...off the steam sterilizer at the power switch during a program run b Check whether the power plug is connected the power cable has suffered damage or a loose contact or loose plug connections is the c...

Page 74: ...etector is blocked by soiling in the building supply d Unplug the leakage water detector control device wait approx 30 s and plug it back in again A switching noise on the water inflow tap black box o...

Page 75: ...vacuum pump has suffered a blockage e g following long shutdown periods b A vacuum pump can be unblocked in the following fashion 1 Acknowledge the malfunction message 2 Switch off the steam steriliz...

Page 76: ...see event 102 203 No log output options have been set Check the configuration in the menu Settings Logging 204 The internal log memory is full Output the log saved in the steam sterilizer on any outpu...

Page 77: ...the CF card is write protected and remove the write protection Upon repeated incidence transfer the present log files from the CF card to a computer and format the CF card in the steam sterilizer and...

Page 78: ...ompatible c The computer is not switched on d The network connection was not configured correctly e The documentation software on the computer was not started a Check whether the network cable has bee...

Page 79: ...Start it again The steam sterilizer is now ready for operation Should this repeat please contact the service technician 438 The steam sterilizer must be validated Arrange for validation of the steam s...

Page 80: ...mp can be unblocked in the following fashion 1 Acknowledge the malfunction message 2 Switch off the steam sterilizer and disconnect the power cable 3 Remove the round plastic cover on the right hand f...

Page 81: ...rounding conditions Noise emission 72 dB A Heat emission with max load 0 95 kWh Ambient temperature 5 40 C ideal range 16 26 C Degree of protection following IEC 60529 IP20 Relative humidity max 80 at...

Page 82: ...2 17G 41 x 14 x 9 cm ME01173 23M 42 x 16 x 6 cm ME01231 23G 42 x 16 x 12 cm ME01232 28M 32 x 16 x 6 cm ME01284 28G 32 x 16 x 12 cm ME01285 MELAstore System MELAstore Tray 50 18 x 11 8 x 3 cm ME01180 M...

Page 83: ...15 Accessories and spare parts 83 Category Article Art no Spare parts Oil for door lock nut ME27515 Test gauge TR16 for door lock nut ME27522 Door seal ME45160...

Page 84: ...rticles in space Corrosion The chemical alteration or destruction of metal ma terials by water and chemicals Delay in boiling This refers to the phenomenon that it is possible under certain circumstan...

Page 85: ...er wrapped in textiles Network cable crossover A crossover cable connects two computers through network cards directly without the use of a hub switch This type of connection corresponds with the netw...

Page 86: ...A closed minimum packaging which prevents the entrance of micro organisms e g through sealing bags sealed and re usable containers and folded sterilization towels etc Sterile material Also referred t...

Page 87: ......

Page 88: ...e 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 BA_Evo_40...

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