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Technical Manual - Frank`s Hospital Workshop

1. N eee uaa ans ee Ne a a OND RW N amp Fig 3 Direct feed water supply from the internal storage tank 1 2 3 4 5 Tank filler cap Sterile filter Safety valve chamber Safety valve double jacket Emergency overflow 7 8 9 1 2 3 4 5 6 One way drain 7 Connection pressure discharge 8 Feed water inlet fitting 9 Power cable 10 Cooler 11 Ethernet 3 Data connection can be retrofitted 12 Ethernet 2 Data connection Example 2 MELAdem 40 Direct of feed water from the internal storage tank Wastewater is collected in the wastewa ter chamber of the storage tank No water connection necessary The autoclave is supplied with feed water directly over a hose from the internal stor age tank Thus no additional water connec tion is required aside from the power sup ply line An integrated float actuated level switch in the device notifies a lack of feed water A program can be started only after water is refilled The used feed water wastewater is col lected in the wastewater chamber of the in ternal storage tank and later drained off manually A float actuated level switch in the wastewater chamber also notifies that the wastewater chamber is full Supply of f
2. EXTERNAL utput of stored log Tries via setting is not changed program respective program BACK selected media for automatic logging SE AUUImTSBC IOBEInd sxe ee to the MAIN menu You can EDIT the output media The selection of thereby 03 Date 12 11 2008 es P PAIS PNEU ICA A EAT im media for the automatic logging keeps unmodified cess to SETUP Menu without messages DAD ua res enu 11 22am adjustable in the SETUP only If automatic Repeat with key 2 in 1 about 5 seconds no processes are started 05 Display contrast or hold logging ACTIVE the output of stored log files V2 0 hold key1 changes the output medium DOCU employs precisely those media which are set in the Automatic logging SETUP menu changes also the counter and markers for the log files that already have been stored for each selected media Automatic logging is ACTIVE Oro eb eack pono 13 Status log Attention All modifications are only effective when MENU exit and SAYE is confirmed with OK Menu exit is still CANCEL 4 v ance OK v x pd EET SRE DER Ro ea Door mode You can NOT start any program in this mode 01 MELAG Vacuklay 41 B Year 2006 Only the door can be operated in door mode E g necessary for opening the door before putting into operation All other processes of the autoclave are inactive BACK to the programmes Darstellung Meaning 4 v m
3. Attention All modifications are only effective when MENU exit and SAVE is confirmed with OK Menu exit is still CANCEL p ea 01 MELAG Vacuklay 41 B Year 2006 02 Serial No 200641 B1333 03 Maint counter 120 Day 05 05 06 04 Batches Day 5 all 5 5 677 357 05 internal storage 10 free 108 You can find data in the operating manual on max load outer dimensions electrical connection weight chamber volume and sterilization space 09 Conduct 11 uiS cm 11 11 Rins val 499 piSl cm 991 333x Version Softwaremodule Updatetile Date 11 v2 31 Firmware FW Nov 21 2008 10 23 41 12 V2 430 Parameters P41 B 26 11 2008 13 v2431 BO BUS B1L B2L 11 12 2008 14 Display Fy DFW Feb 24 2006 09 41 35 15 v2 20 Display symbols DS 08 22 2008 18 17 02 pT ec Additional drying MELAG Contrast setting You can set the contrast of the Display in the SETUP menu To do So se lect the option Display Contrast Press Edit so that reverse display appears Increase or reduce the contrast of the display by holding down the navigation keys respectively Exit the SETUP menu by pressing MENU exit and SAVE to permanently save the contrast setting Counter readings You can retrieve counter readings and other current technical data of the autoclave in the INFO Menu Counter Readings To get to the menu simultaneously press the keys 2 3 Program modifications The autoclave pro
4. An error can occur during or after an update if the data transfer or the un packing or copying of the update files does not proceed correctly You can check the precise size of the file under file properties Not to be mis taken with size on the data medium These can be different for every data medium For the boot loader update the CF card is inserted while the LED shortly illuminates for about one second boot loader phase after the autoclave is switched on Plug the CF card into the slot while the device is still switched off press on the black ejection pin and leave the CF card in this position in the card slot This procedure facilitates a rapid and correct insertion of the CF card if the LED illuminates after the autoclave is switched on The display re mains blank Depending on the technology it can subsequently immedi ately come to a renewed firmware update Therefore be sure to wait until the autoclave displays the start up screen this can take up to 7 minutes Which CF card can use for an update You can employ every CF card formatted with FAT 16 file system as an update CF card The CF cards delivered from MELAG are already format ted accordingly As it is possible to record graphic logs on the CF card above version 2 4 we recommend using only CF cards with 1GB or more memory capacity preferably MELAG approved MELA ash CF cards It is well known that some older CF cards with 256 MB memory capacity cause file
5. 6 mbar l SF 13 3170 i SIS 1919 9 S N HFIS S Eells H d Fig 6 Pressure Time chart for Universal Program 134 C and 2 1 bar 1 Pressure mbar Fress mbar Fig 7 Pressure Time chart for Quick Program B 134 C and 2 1 bar 23 Technical Manual Vacuklav 41 B and Vacuklav 43 B Pressure mbar Fig 8 Pressure Time chart for Quick Program S 134 C and 2 bar Pressure mbar Fig 9 Pressure Time chart for Gentle Program 121 C and 1 1 bar 24 Technical tables Pressure mbar 3170 Mee Press mbar Fig 10 Pressure Time chart for Prion Program 134 C and 2 1 bar Quality of the feed water Residue on evaporation Heavy metals except for those named above Hardness Table 15 Minimum requirements to the feed water following the EN 13060 Appendix C 25 Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG Frequently asked questions FAQ about the 26 software Version 2 4 Version V2 3 Version V2 2 V2 0 Network capability V2 0 Intelligent batch documentation Which improvements do the software versions V2 0 V2 2 and V2 3 V2 4 contain A program start time can be pre set to any time using the pre selec tion Start time function key 4 Additional drying is selection using the 1h key The energy saving mode was supplemented in the SETUP menu The program Draining was supplement
6. most current software ver and compare the version states in the corresponding directory sion Since if Internet Explorer 7 is used there might be problems in download Notice ing the software we recommend using an alternative internet browser e g Mozilla Firefox yes no gt continue to 3 2 Please download the files and possibly update all your update CF cards Then continue to 3 Is the autoclave version at 3 You can determine the version of the firmware in the screen image If you the latest version status press the two middle keys 2 and 3 shortly together in an arbitrary display image the status display appears The higher the four digit version num ber e g firmware V2 306 the more current is the version see Question 14 page 14 Do not update versions that are older than those displayed on the auto Attention clave D circuit boards do not function with versions 2 2xx or older 41 Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG 42 yes no gt No update neces continue to 4 sary end Have you archived all the ex 4 Forthe update of Version 1 to Version 2 of the autoclave software there is isting logs on a CF card that yet no warning that subsequent to a firmware update all logs are lost which are still in the internal auto are found in the internal autoclave storage and were not yet backed up on clave storage an external storage medium Therefore be sure to back up all program malfunction statu
7. IEC 61000 3 3 Table 2 Electromagnetic compatibility Emitted interference measurements Interference im IEC 60601 Compliance level Electromagnetic environment guideline munity tests test level Electrostatic dis charge ESD as per IEC 61000 4 2 Rapid transient electrical disturb ances bursts as per IEC 61000 4 4 Surges as per IEC 61000 4 5 Voltage drops short term interrup IEC 61000 4 8 6kV contact discharge 8kV air discharge 2kV for mains cables 1kV for input and output cables 1kV push pull voltage 2kV common mode vol tage lt 5 Ur 5 sag of the UT for 75 period lt 70 Ur 30 sag of the UT for 25 periods lt 5 Ur 95 sag of the UT for 5 s 6kV contact discharge 8kV air discharge 2kV for mains cables 1kV for input and output cables 1kV push pull voltage 2kV common mode vol tage lt 5 Ur 95 sag of the UT for 7 period lt 40 Ur 60 sag of the UT for 5 periods lt 70 Ur 30 sag of the UT for 25 periods lt 5 Ur 95 sag of the UT for 5s UT is the ac mains supply before the application of the test level Table 3 Electromagnetic compatibility Interference immunity tests 1 Floors should be made of wood or concrete or laid with ceramic tiles If the flooring is furnished with synthetic material the relative humidity must be at least 30 The quality of the supply voltage should corres pond to a typical business or
8. Power cable Safety valve chamber Sterile filter Safety valve double jacket Emergency overflow One way drain Connection pressure discharge Purified feed water inlet for MELAdem swivelling threaded fitting for hose 8x1 alternatively straight 23 Back foot of the unit 24 Cooler Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG Installation and setting up Warning LN Warning Unpack autoclave Remove carrying strap After switching on Welcome 200 286 Wwe ewee re PN A M Tiu i a Notice Please read the User Manual of the autoclave and the water treatment unit before setting up the autoclave If the autoclave has already been put into operation please observe the following before setting up again in case of any eventual transport m To transport the autoclave for instance if the practice moves to a new location wait until the pressure indicator on the manometer display shows null bar after the autoclave is switched off Be sure to check the pressure indicator on the manometer before moving the autoclave m To transport the unit over longer distances an authorised person must prepare the autoclave beforehand according to instructions and completely empty the double jacket steam generator In order to do SO you can use the Draining program in the SPECIAL menu Non compliance can lead to severe burns and damages to the autoclave as well as malfunctions The au
9. Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG Declaration of conformity Vacuklav 44 B Vacuklav 43 B Declaration of conformity according to EN 13060 for small steam sterilizers Manufacturer MELAG oHG Address Geneststra 5e 9 10 10829 Berlin Country Germany Product oteam sterilizer autoclave Type of device Vacuklav 41 B Vacuklav 43 B Classification Class 2a We herewith declare that the above designated product conforms to the general re quirements set forth in the EN13060 Standard and has successfully passed the Type tests according to EN 13060 for fulfilling requirements on a device with Class B Sterilization program B method Berlin 12 03 2008 General Management Quality Made in Germany Evidence Based Sterilization www melag de Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG Certificate of Suitability Vacuklav 41 B Vacuklav 43 B According to the recommendations of the Commission for Hospital Hygiene and In fection Prevention at the Robert Koch Institute of April 2006 Manufacturer MELAG oHG Address Geneststra 3e 9 10 10829 Berlin Country Germany Product oteam sterilizer autoclave Type of device Vacuklav 41 B Vacuklav 43 B Classification Class 2a We herewith declare that the above designated sterilizer is suited for sterilization of Solid instruments wrapped and unwrapped Porous goods wrapped and unwrapped Hollow bodies instrum
10. be easily inserted completely without force with the appreciably raised handle corner edge pointing to the left towards the display Switch the autoclave on The update process begins automatically Appropriate references appear in the display in English The process takes about 5 minutes The LED illumination on the card slot can be interrupted between downloading the files The update is terminated when the wel come screen appears on the display Then remove the CF card from the card slot If the CF card is not removed a renewed update takes place the next time the autoclave is switched on The update procedure may under no circumstances be interrupted by removing the CF card or switching off the device This can result in data loss 1 Please be sure to verify the version states of the software modules see Question 14 The execution of the boot loader update process is only necessary if the LED blinks after switching on the autoclave with inserted update CF card Such a situation arises only seldom for instance if the current fails during the update or the update CF card is removed during the download LED lights up Then the autoclave lacks the most important software module the firmware A bootload is only to be used as a last resort and only after consultation with MELAG if after a correctly executed firmware update the old version nevertheless remains on the device You can determine this when verifying the update result
11. corresp toca 0 09K steam Drift in 5 years 1 0 corresp to 40 mbar corresp toca 0 44K steam Table 7 Precision and drift behaviour of the pressure sensor Precision and drift behaviour Measuring chain Drift per year 0 005 K Drift in 5 years 0 025 K Table 8 Precision and drift behaviour of the measuring chain for the temp measurement on the electronics w o sensor 0 2 corresp to 8 0 mbar corresp toca 0 09K steam Drift per year 0 004 96 corresp to 0 16 mbar corresp toca 0 017K steam Drift in 5 years 0 02 corresp to 0 8 mbar corresp to ca 0 09K steam Table 9 Precision and drift behaviour of the measuring chain for the pressure measurement on the electronics w o sensor Precision and drift after 1 year Precision at 135 C at pure addition of indiv errors ca 0 70 K Precision at 135 C per Gaussian law of propagation ca 0 47 K Table 10 Precision including drift of the entire measuring chain of the temperature measurement after 1 year Precision lat pure addition of indiv errors 0 70 96 corresp to 28 0 mbar corresp to ca 0 30 K steam temp Precision per Gaussian law of propagation 0 41 96 corresp to 16 5 mbar corresp to ca 0 18 K steam temp Table 11 Precision including drift of the entire measuring chain of the pressure measurement after 1 year Precision and drift after 5 years Precision at 135 C at pure addition of indiv errors ca 0 70 K Preci
12. hospital environment The quality of the supply voltage should corres pond to a typical business or hospital environment The quality of the supply voltage should corres pond to a typical business or hospital environment If the autoclave user demands continual function ing of the device even when there are interruptions in the energy supply we recommend supplying the autoclave from an interruption free power supply or a battery Magnetic fields with the mains frequency should correspond to the typical values found in the busi ness and hospital environment 19 Technical Manual Vacuklav 41 B and Vacuklav 44 B 20 Interference im IEC 60601 Compliance level Electromagnetic environment guideline munity tests test level Portable and mobile radio equipment should not be placed closer to the autoclave including hoses and pipes than the recommended protective distance calcu lated according to the formula for the transmitting fre quency conducted HF dis 3 Ver see table below Recommended protective dis turbances as per 150 kHz to 80 MHz a IEC 61000 4 6 The field intensity of stationary radio transmitters should be less than the compliance level for all frequencies ac cording to an on site investigation radiated HF dis 3 3 turbances as per V m Co IEC 61000 4 3 80 MHz to 2 5 GHz A Disturbances are possible in the environment of devices bearing this symbol This guideline might not be applica
13. program cycle was created with O No printer available leakage rate and successful the log printer MELAprint 42 and pasted into lower run of the Universal Program were recorded in the fields provided for this purpose fields provided for this purpose n Check the time setting if necessary reset the time according to instructions in the User Manual O Time is correct or correctly reset Reset service meter according to separate instructions O Service meter is reset O Service meter is not reset Instructing the operating personnel and handing over the technical documentation O Instruction on documenting with CF card to archive and print out the data has been concluded Operating personnel were instructed User Manual was handed over O Technical Manual was handed over O O O Chamber certificate was handed over O MDD Certificate of Conformity was handed over O Warranty Certificate was handed over The device was properly installed by the above named technician O without fault O with fault Logs Universal program Please paste and fold up logs here if no printer is available then enter leakage rate and successful comple tion of the Universal program 16 Technical Manual Vacuklav 41 B and Vacuklav 43 B 18 US Dialer proc T2s 12 11 2008 D4 Time naaa 11 22am 05 Display contrast 0B Language 00001 07 Energy saving mode Setting b DIAGNOSIS SERVIC INFO DOCU MENU exit and SAVE
14. system problems whilst recording graphic protocols implausible files on the CF card If an update CF card is in the card slot of the autoclave then the update files are automatically recognized by the software modules every time the device is switched on see Question 14 and the autoclave is up dated with this software The update files must be in the main directory of the CF card Files in Frequently asked questions FAQ about the software Update from Version 1 to Version 2 The prerequisite for a cor rectly executed update is the employment of the correct parameter module In general the choice of two languages is possible Replace languages i ap Languages are valid for all device types 17 sub folders are permitted They are ignored Logs or other files in the main directory do not disturb the update For the update from Version 1 to Version 2 the autoclave software only updates the modules 1 to 5 in the simplest case the modules 1 to 5 are together on a CF card which then is employed for a certain type of device Software modules can also be individually updated when this is compatible with the other modules The file with the old name 11030 mot is still used only for the update from Version 1 to Version 2 for the firmware module The file with the new name FW 2xxx mot from Version 1 is not recognized The contents of the two files are identical Take care that the parameter module corresponds to the type
15. the standard version to one with a water treatment unit empty both chambers of the internal storage tank The feed water inlet fixture 5 on the autoclave must be exchanged with the hollow screw MELAG Art No 53430 with feed water inlet fixture for hose 6x1 MELAG Art No 21140 because of the other hose diameter Likewise exchange the two Cu seals MELAG Art No 42360 in the water connection set The used feed water wastewater is conducted under pressure directly over the one way drain hose MELAG Art No 39180 into the siphon of the domestic water supply An automatic one way overflow is also possible and is described in example 9 13 14 Installation and setting up MELAG Example 3 MELAdem 47 Supply of feed water from the re 18 17 14 18 verse osmosis unit MELAdem 47 Drain via one way drain and double chamber wastewater trap Connection of the reverse osmosis unit MELAdem 47 which can be directly at tached to the purified feed water inlet of the autoclave Other water treatment units with corresponding water quality can also be connected after consultation with MELAG ES Fig 5 Feed water supply from the reverse osmosis unit MELAdem 47 Tank filler cap Safeguard combination consisting of a return flow inhibitor and pipe aerator according DIN EN 1717 optional One way drain Feed water tap Feed water inlet fitting swivelling threaded fitting for hose 26x1 al
16. total batch number is cited in the log header How can I format a CF card at the autoclave itself All saved data on the CF card is deleted during formatting Therefore you should check the CF card contents and save possibly existing backup re cords or other data on the PC or on some other storage medium 1 Stick the CF card correctly into the card slot noticeable raised rib at the edge points to the display on no account apply force 2 Select main menu gt SPECIAL Menu gt DOCU Menu gt Media se lection in screen Key CONTINUE gt 15 Format CF card gt Format CF card in screen Button YES 3 Ifthe message formatting completed appears you can re move the CF card How is a CF card formatted at the PC so that it is re cognized by the autoclave The following is therefore only conditionally interesting The CF card must be formatted with the file system FAT16 Only on cards formatted in such a manner can the autoclave store or read data Cards delivered by MELAG are already correctly formatted The formatting on the PC can be done without problems only with Windows XP 1 Plug the CF card into the MELAflash card reader which is installed and connected at the PC 2 Click START 3 Click Execute 4 Enter the format command as specified below in the input field of the Execute window X stands for the letter of the hard drive of the card reader A determines the cluster size on the CF card which varies de pending on
17. ELAG12345 The figures can be changed here The user name SN with password must be saved in the FTP server Determine computer for FTP 2 Since of the autoclave itself is furnished with a hub a network en server program sues with the direct connection of a computer to the autoclave Therefore the procedures for direct connection or on connection via a network only differ slightly In a network the computer must be determined on which the small FTP server program should run This program receives the logs via data transfer The autoclave seeks this computer with the help of the IP address which is set in the autoclave and registers at the FTP Server The logs of the completed programs are later also stored on this computer When selecting the computer take into account that it would be of advantage to include the stored logs in the automatic data backup of the medical practice Determine the IP address of 3 Get the IP address of the computer from the computer administrator the computer or determine it yourself see Question 11 page 33 Determine the network 4 n principle the following applies The selected computer must always situation receive a fixed IP address independent of automatically or manually configured networks For automatically configured networks the DHCP server must be in formed of the range of the number or the number itself as a static IP address The computer can also be assigned several IP addresses in c
18. MELAG Technical Manual Autoclave Vacuklav 41 B Vacuklav 43 B For Users and Service personnel Please read the accompanying User Manual before you start operation of the auto clave The instructions contain important safety precautions Make sure to keep the Technical Manual together with the User Manual near the autoclave The instructions are part of the product C 0124 Foreword This manual has been created for the autoclaves Vacuklav 41 B and Vacuklav 43 B They are identical except for their chamber depth and device depth The device name autoclave is used to designate the steam sterilizers Vacuklav 41 B and Vacuklav 43 B You also receive a User Manual with the autoclave It contains important safety instructions and information which you need to operate the autoclave Read the User Manual completely through in proper sequence before beginning operation with the autoclave This Technical Manual includes declarations of conformity suitability statements and recommendations instruc tions for setting up installing and initial start up of the autoclave including installation record extended technical information on the software and hardware and other technical data The Technical Manual is meant for inter ested persons and service personnel Technical Manual Vacuklav 41 B Vacuklav 43 B MELAG Medical Technology Berlin Valid for Vacuklav 41 B Vacuklav 43 B as of software version 2 4x 1st Edition Februar
19. ase the one already existing in the computer cannot be employed Autoclave and computer must belong to a sub network This means in the majority of cases that the IP addresses of the sub network must agree with the first three numbers e g 192 168 40 xx 34 Frequently asked questions FAQ about the software MELAG Connect Ethernet cable Enter established IP ad dresses Server installation EE Notice EE Notice EP Notice Testing The IP addresses of the autoclave and computer must be different in the fourth number e g IP autoclave 192 168 40 40 and IP com puter 192 168 40 140 The default setting of the IP addresses in a MELAG autoclave satis fies this prerequisite a autoclave computer with 1 1 cable b autoclave gt network with crossover cable If so called intelligent switches are employed in the network then the type of cable is of no consequence Every interface can be em ployed on the autoclave Enter the established IP addresses for the autoclave and connected devices at the autoclaves see Question 10 page 31 The following example describes the MELAG FTP server Copy the installation file of the FTP server to your computer and start the in stallation If you have already acquired MELAview V2 0 start the in stallation directly from the installation assistant from MELAview V2 0 and follow the installation instructions In order to be able to install the MELAG FTP server the free me
20. ble in all cases The dispersion of electromagnetic magnitudes is influenced by the absorp tion and reflection of buildings objects and people The field intensity of stationary transmitters such as e g base stations of radio telephones and mobile land radio devices am ateur radio stations AM and FM radio broadcasting and TV transmitters are not able to be exactly theoretically determined be forehand You should consider conducting a study of the location to determine the electromagnetic environment with respect to the stationary transmitters If the measured field intensity at the location where the autoclave is to be used exceeds the above compliance level then observe the autoclave carefully to verify its proper functioning If unusual performance characteristics are observed additional measures might be required such as for instance modifying the alignment or finding another location for the autoclave 5 Within the frequency range of 150 kHz to 80 MHz the field intensity should be less than 3 V m Table 4 Electromagnetic compatibility Interference immunity tests 2 Recommended protective distances Between portable and mobile The autoclave is designed for operation in an electromagnetic environ HF telecommunication ment in which the HF disturbances are monitored The customer or the devices and the autoclave user of the autoclave can thus help to avoid electromagnetic disturbances by complying with the minimum distance required b
21. can be interrupted between the downloading of the files There fore you must wait until the start screen droplet picture appears Storing of logs on the MELAflash CF Card the process takes longer as of V2 0 due to the automatic verification and creation of the direct ories How do I recognize the batch number of the com pleted cycles You have the following options for examining the batch number of a com pleted cycle After a completed cycle also for programs terminated by the operator or system an end screen display appears As of V2 0 the entire batch num ber of the concluded program is displayed here in the user interface In the end image you can display the log header by pressing the button MELAG Technical Manual Vacuklav 41 B and Vacuklav 43 B In the log header Attention Procedure for formatting As of V2 0 it is possible and safer to format the CF card at the autoclave see question 5 Windows xP Home Edition Systemsteuerung ey Programmzugriff und standards u verbinden mit amp Hilfe und Support Suchen Ge Susfihren m Start o Ausschalten In the log header Geben Sie den Namen eines Programms Ordners Dokuments oder einer Internetressource an ffnen format x A 1024 v E X A 10 l _ format Ces estar MELAG DOCU where you can ascertain for instance the day and the entire batch number In every log paper printout or file the
22. cm seteor 05 Display contrast or hold 0B Language 00001 07 Energy saving mode Setting 636 314 b DIAGNOSIS SERVIC INF O DOCU MENU exit and SAVE 01 Water supply EXTERNAL 02 Automatic logging ACTIVE 3 Batg 1e se 12 11 2008 Attention All modifications are only effective when MENU exit and SAYE is confirmed with OK Menu exit is still CANCEL Access to DIAGNOSIS and SERVICE area only for authorized persons 02 Serial No 200641 B1333 03 Maint counter 120 Day 05 05 06 04 Batches Day 5 all 5 5 05 internal storage 10 free 108 06 output media CF Card Computer Printer lmmed Format automatic logging YES YES NO YES 00001 not yet alread 1 5 5 4i4 09 Conduct 11 uiS cm 11 11 Rins val 499 Sliem 991 333x Version Softwaremodule Llpdatefile Date 11 v2431 Firmware FW Nov 21 2008 10 23 41 12 v2430 Parameters P41 B 26 11 2008 13 V2431 BO BUS B1L B2L 11 12 08 14 Display Fy DF Feb 24 2006 09 41 35 15 v2 20 Display symbols DS 08 22 2008 18 17 02 ANALOG DIGITAL BACK COUNTER prse ONU SRI aa 619 382 Status display of the autoclave You can permit the status indication in every display screen The display automatically jumps back to the initial image after 30 sec The status display of V2 0 deviates 14 System log 15 CF Card formatting 02 Last log 03 Daily log file 04 Log
23. data from the autoclaves in paral lel The FTP server supports the so called multithread capability In the FTP server program you can determine the folder in which the device directory and protocol files should be stored Above version 2 4 the password for the FTP server consists of Warning MELAG five adjustable digits standard MELAG12345 If your autoclave is already connected to a network via an FTP serv er the previous password MELAG in the FTP server program must be changed to the new password Otherwise no further logs will be transferred after the update The digit sequence for the FTP server password can be changed in the autoclave in the SETUP menu Please ensure that the new pass word is also adapted in the FTP server The passwords to the auto clave and computer must always correspond so that logs can also be transferred to your computer faultlessly after updating or changing the digit sequence Change FTP Server Pass SETUP Menu gt 02 Automatic logging gt key 4 EDIT gt key word Attachment 4 CONTINUE gt with navigation keys to LAN TCP IP FTP gt key 4 depressed RETURN une RU r EDIT gt with navigation keys to FTP Server Password Attach nomal Sting 817 596 ment gt key 4 EDIT gt digits inversely highlighted and then can modi FTP Server Password Attachment fied with the keys Password figures 12345 The autoclave logs itself into an FTP server with a password On delivery it is M
24. dia library Microsoft NET Framework 2 0 or a higher version must be installed on your computer Start the program by left double clicking on the FTP symbol on your desktop In the register user create the autoclave as a new user User name serial number of the autoclave e g 200440 B1000 user pass word MELAG12345 Click on the folder and choose the favoured directory 5 MELAG FTP Server rome Server User i Help Info Username 200440 B 1000 Username File folder 200440 B 1000 C Mogs User password EER EAE AA File tolder Enter the four digits of the year of construction as the user name Device labels show only the last two digits of the year of construction Example If the label contains 0440 B1000 enter exactly 200440 B1000 as the user name Moving the FTP server to another folder on the computer results in the loss of the user settings The FTP server is started by double clicking on the link symbol on the desktop or the FTP symbol in the Windows start menu Depending on the computer s configuration it might be necessary to inform the computer s firewall that the FTP server is an exception With SPECIAL Menu gt DOCU Menu gt you can create system and status logs since these are also always available without a running program The logs document all current settings of the autoclave and can be employed for testing Furthermore make a test run with the immediate output o
25. e Version 2 3 from the update file in MB 11 Dec 08 Firmware 28 11 08 FirmWare module FW 2431 Parameters 26 11 08 Parameters module P41B 2430 so usermefae Ulcmsssot i 0 1 4 4 3 Display FW Feb 24 2006 Display driver FirmWare Do 5 74838 7 74 Symbols 08 22 2008 Display Fonts symbols characters DSY 2420 0 4 o independent of type a file applies for all types of units and is same for all types all extensions m independent of type but dependent on desired language are mot 11 12 08 2nd Language language module B2L 2431GB independent of type but dependent on language regarding font gt type dependent every type of unit needs its respective file Table 21 Modules of a software package 15 How do I conduct an update See checklist for software Carrying out the update procedure is uncomplicated It cannot cause an update page 41 autoclave malfunction Device specific numbers such as the serial num ber overall charges and maintenance counter are not changed e Ensure that the autoclave device type and the parameter file of the up Notice date CF card correspond The parameter update files of the V 2 4 do not exceed the IP addresses during the update procedure CF card Prerequisite is an update CF card see Question 16 suitable for the device type of the autoclave which you can also assemble yourself The update to V2 0 software still does not contain any warning
26. e directly or over the computer network Simple network integration of the autoclaves by means of IP address menu Every combination of the output medium CF card computer and MELAprinf can be set For every selected medium autoclave stores log records that have not been outputted and outputs these automatically at the next oppor tunity Autoclave automatically creates its own directories on the CF card or computer device directory therein month directories directory is doubled Three formats can be selected for the report output 0 without pro gram steps 1 with program steps without explanation 2 with pro gram steps and their explanation Electronic stamp in the journal as authenticity proof assurance Frequently asked questions FAQ about the software V2 0 DOCU menu V2 0 Door V2 0 Miscellaneous short lighting up 1 s Blinking every 0 5 s Long lighting up to 1 min Attention Flicker lighting up of the LED at irregular intervals On the end image of the display With the DOKU key against manipulation Formatting CF Cards at the autoclave is possible Aside from the automatic log any number of media can be selected for a manual log output Still more criteria for the selection of log output Individual output of logs with the journal list including sort function Specification of a consecutive identification number of the device even
27. e operator s in accordance with good en gineering practice and provide instructions in its use 10829 Berlin Please copy fill out and sign this form and send it to us after the autoclave has been successfully in stalled The returned form is prerequisite for the MELAG factory warranty Device and installation data We hereinafter referred to as specialist MELAG dealer have today installed instructed the personnel and performed the initial start up of the autoclave Vacuklav 41 B 43 B as described below Specialist dealer name address stamp Operator name address stamp E mail address for software update E mail address for software update Serial No Vacuklav 41 B 43 B Remarks Please place checkmark where applicable O First installation O Subsequent installation The following persons were present during the instructions for use Name first name please print in block letters Signature From dhebracuceelhle iuicolstbesogpcatise Una a aa aaa a aa iq oia qM Name first name please print in block letters Signature Msracing technician NN p mE FROMVING COMPANY eost Rip Itt tini ute Decca tease a 15 Record of installation and setting up MELAG Executed work ul Please confirm the respective points with a checkmark after completion of the described task Secure feed water supply depending on installation variant Right feed water chamber of the internal storage tank filled up with feed wate
28. ears 4 You must then remove the CF card from the card slot otherwise a renewed update takes place when you switch on the autoclave the next time 5 continue to 7 Was the update process 7 Verify the version states of the software modules successful In an arbitrary display press the two middle keys 2 and 3 shortly together Verify in the status display which appears Line 1 Is the type correct Line 2 The serial no is not allowed to have changed and may never be precisely 1000 619 362 05 internal storage 10 free 108 06 output media CF Card Computer Printer lmmed Format automatic logging ei YES NO YES 00001 not yet alread 5 5 4 4 09 Conduct 11 pS cm rE 11 Rins val 499 Siem 99 333x ion Softwaremodule Updatefile Date 1f 2 431 Firmyare FW Nov 21 2008 10 23 41 2 v2 430 Parameters P41 B 26 11 2008 3 BUS B1L B2L 11 12 08 Display Fy DF Feb 24 2006 09 41 35 192 42 Display symbols DS 08 22 2008 18 17 02 Lines 11 12 13 15 Are the versions of all four principal parts of the soft ware in fact updated to the most current version V2 4 The status display automatically jumps back to the initial screen after 30 seconds You can also press BACK yes End MELAG no Carry out update process once again look for ap propriate error in FAQ or contact MELAG 43
29. echnical Manual Vacuklav 41 B and Vacuklav 43 B Autoclave itself 192 168 40 40 Default setting ex factory 192 168 40 140 Default setting ex factory Table 18 IP addresses saved in the autoclave 32 Frequently asked questions FAQ about the software MELAG There are two different pos sibilities for integrating into a practice network Automatically configured network DHCP Manually configured net work Access to the parameters IP addresses i OR i m Determination of the IP ad dress of a PC under Win dows XP Procedure when connecting the log printer If not successful 11 12 In the standard ex factory delivery the autoclave contains IP addresses that all belong to the network with the above cited sub network mask To integrate the autoclave into a medical practice network and only then two possibilities are to be distinguished The network is automatically configured That means the IP addresses are awarded dynamically It is currently not possible to administer the autoclave automatically in a dynamical network If the network is manually configured then the sub network mask of the medical practice network must be known If another sub network mask is used than the one preset in the autoclave a software expert should adapt the IP addresses in the autoclave If the masks conform and the above mentioned IP addresses are not assigned then a printer can be connec ted directly or via the n
30. ective cap for manometer to display the pressure of the double jacket steam generator Cap for emergency opening of the door Mains switch concealed accessible from the side Ethernet 1 Data connection Reset button overheating protection Front foot of the unit adjustable behind covering Back side 11 Tank filler cap Ethernet 2 data connection Ethernet 3 data connection can be retrofitted Power cable Safety valve chamber 16 Sterile filter 17 Safety valve double jacket 18 Emergency overflow 19 One way drain 20 Connection pressure discharge 21 Purified feed water inlet for MELAdem swivelling threaded fitting for hose 8x1 alternatively straight 22 Back foot of the unit 23 Cooler Fig 1 Front and rear view Technical Manual Vacuklav 41 B und Vacuklav 43 B MELAG Device views Flex Display Front side r3 1 Protective cap for slot of the CF card 2 Control panel 3 Door pivot opens to the left 4 Protective cap for manometer to display the pressure of the double jacket steam generator 5 Cap for emergency opening of the door 7 Mains switch concealed accessible from the side 8 Ethernet 1 Data connection 9 Reset button overheating protection 10 Front foot of the unit adjustable behind covering Back side 1 Tank filler cap Ethernet 2 data connection Ethernet 3 data connection can be retrofitted
31. ed in the SPECIAL Menu Logs can now be read out by a suitable program e g MELAview V2 0 via a TCP Port he FTP server password consists of the word MELAG a five digit sequence which can be changed in the SETUP Menu under LAN TCP IP FTP gt FTP Server Password Attachment During a program run it s possible to record graphic logs in real time via a CF card or computer and displayed in MELAview V2 0 as a curve diagram We recommend using MELAflash CF cards with a min imum of 1GB memory capacity Bycalling up the MELAnet website it is possible to follow the program status on the computer during a running program via a browser win dow Changes of the Quick Program B unwrapped into Quick Pro gram B for single wrapped instruments loading with simple packaged instruments up to maximum 1 5 kg or with unpacked instru ments up to maximum 5 kg is possible With the new key DETAILS the log recording state conductivity tem peratures pressures and software version can now be displayed in alarm and fault messages Selection state of the journal list in the DOKU menu is now retained after OUTPUT Further improved recognition of CF cards of other manufacturers Insignificant change of the keyboard layout for messages Employment of CF cards of diverse manufacturers possible Batch documentation in the SETUP Menu now means Automat ic logging Computer and or MELAprint 42 can be connected to the autoclav
32. eed water from the lon exchanger MELAdem 40 Pressure discharge is directly connec ted with siphon Installation and setting up MELAG Connection of the ion exchanger MELAdem 40 with MELAjef The simplest installation is to connect the MELAdem 40 directly to the purified feed water inlet of the autoclave and thus generate deminer alized water from normal tap water The spray pistol MELAjef is for the final rinsing of the instruments with demineralized wa ter before sterilization Fig 4 Feed water supply from the lon exchanger MELAdem 40 Safety combination consisting of return flow inhibitor and pipe aerator according to EN 1717 1 2 MELAjef MELAG Art No 30300 optional 3 MELAdem 40 4 One way drain 5 Feed water inlet fitting swivelling threaded fitting for hose 6x1 alternatively straight 6 Inlet hose feed water 7 Feed water filter MELAdem 8 Wall drain available on site 9 Double hose nozzle with anti flooding flap MELAG Art No 37400 in the surface mounted siphon contained in Art No 37410 10 Pressure discharge hose MELAG Art No 39180 11 Water tap available on site 12 Leak monitor water stop with shut off valve and probe MELAG Art No 01056 optional recommended with fixed water connection 13 Power cable 14 Cooler 15 Ethernet 3 Data connection can be retrofitted 16 Ethernet 2 Data connection Before you upgrade from
33. ents Type A wrapped and un wrapped Hollow bodies instruments Type B wrapped and un wrapped Instructions on load quantities and loading variants are set forth in the User Manual and must be observed Be sure to observe the manufacturer s instructions for medical devices intended for sterilization according to DIN ISO 1 7664 General Management Berlin 12 03 2008 Quality Made in Germany Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG Evidence Based Sterilization www melag de Technical Manual Vacuklav 41 B und Vacuklav 43 B MELAG Suitable test body Vacuklav 41 B Vacuklav 43 B According to the recommendations of the Commission for Hospital Hygiene and In fection Prevention at the Robert Koch Institute of April 2006 Manufacturer MELAG oHG Address Geneststra 3e 9 10 10829 Berlin Country Germany Product oteam sterilizer autoclave Type of device Vacuklav 41 B Vacuklav 43 B Classification Class 2a We herewith declare that the following test system is suited for testing the above cited sterilizer Product Helix Test body according to EN 867 5 Type designation MELAcontroP Berlin 12 03 2008 General Management Quality Made in Germany Evidence Based Sterilization www melag de Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG Device views Front side Protective cap for slot of the CF card Control panel Door pivot opens to the left Prot
34. er time Server started on Port 21 Over a longer time period the following lines are repeated lt 14 12 22 192 168 40 100 USER 200440 B1000 lt 14 12 22 192 168 40 100 USER 200440 B1000 lt lt Incorrect login or password gt gt The following rows enter c every eight seconds lt 14 03 22 192 168 40 100 USER 200440 B1000 gt 14 03 22 192 168 40 100 USER 200440 B1000 lt lt is logged in gt gt gt 14 03 52 192 168 40 100 USER 200440 B1000 lt lt C Docu ments and Settings Admin own files protocols gt gt lt 14 12 22 192 168 40 100 QUIT Table 19 Possible messages in the window of the FTP server and their significance Cable connection defective IP address of the computer not set correctly in the auto clave see Question 10 page 31 the password MELAG 12345 was not entered correctly Successful handshake between autoclave and FTP server in which however no autoclave protocol was im ported 14 How can I verify the version of the autoclave soft ware As of V2 0 by the file names As of software Version V2 0 you can recognize the contents or the ver sion of the update files directly by the file names Version check in the INFO menu Check the version state of the software on the autoclave e g after a up date process on the running autoclave on main menu gt INFO Menu gt 21 Technical data gt installed software versions Or faster via the status dis Or by
35. etween portable and mobile HF telecommunication devices transmitters and the autoclave depending on the power output of the communication device as stated below For transmitters whose maximum nominal power is not specified in the fol lowing table the recommended protective distance d in meters m can be determined by using the equation in the respective column whereby P is the maximum nominal power of the transmitter in watt W according to the specifications of the transmitter manufacturer Nominal power of the transmitter Protective distance depending on the transmitting frequency m W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 124P d 124 P EEEN d recommended protective distance in meters P maximum nominal power of the transmitter in watt according to information of the transmitter manufacturer Table 5 Electromagnetic compatibility Protective distance depending on the transmitting frequency m Technical Manual Vacuklav 41 B and Vacuklav 43 B Technical tables Precision and drift behaviour Sensors Sensor type PT 1000 Class A according to DIN EN 60751 Precision at 135 C 0 42 K Drift per year 0 05 K Drift in 5 years 0 25 K Table 6 Precision and drift behaviour of the temperature sensors n Sensor type piezoresistant absolute pressure sensor 0 to 4000 mbar 0 3 corresp to 12 mbar corresp to ca 0 13K steam Drift per year 0 2 corresp to 8 mbar
36. etwork without having to set anything gt SETUP menu gt 02 Automatic Logging key 4 EDIT gt key 4 CONTINUE gt with keys to line LAN TCP IP FTP with keys to Autoclave IP gt with key 4 EDIT Modify IP addresses Adjustment of the numbers in the screen Modify IP addresses can be accelerated by keeping the keys pressed longer than one second whereby upon release the value runs on for about 20 counts Adjusted IP addresses are only permanently saved upon exiting the SETUP menu via the MENU Exit and SAVE and also only then are they correctly visible How do l ascertain the IP address and network set tings of a PC in Windows XP 1 Start gt Settings gt Network connections gt LAN connec tion gt Register Network Support gt Start IP Address 2 Forinstance you can discern whether a PC is integrated into a dy namic network Start Settings Network connections right mouse button on LAN Connection gt Properties Scroll in the window This connection uses the following ele ments to Internet protocol TCP IP and click with left mouse key then press on button Properties If in the window Properties of Internet protocol TCP IP the option obtain IP address automatically is selected the PC in the network is dynamically addressed How is the MELAprinf log printer directly connec ted to the autoclave 1 The actual network function is carried out by a MELAG network ad apter Type No 40295 2 Prerequ
37. eusececsueueeeessaeseeecsuaeeeesseeeeeessuasseesssageseneness 22 Nomipnabvalue TolerariCeS uiotsordtita eroe dx RD uae dedic zur atultaxisu suagan Bex Dade Saut ates di uteri Tone sea SUP Vut V eid Dodd andre 23 PRESS URC MS CANS 2 ERE 24 Quality of the feed WaIQGD sociatus decer vae hene dr cod tiec pn pe vue uu cda imuidear nu t cod sera Sou jae 26 Frequently asked questions FAQ about the software lees cesses eese enne enne nnn nnn nnn nnn 27 Checklist for Software update ioi ob ac uoa dece dere Det E quce eUvL cnet c ded vov a cord vedo CV YU E 42 Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG Declaration of conformity Vacuklav 41 B Vacuklav 43 B In accordance with the EC guidelines for medical devices 93 42 EWG Manufacturer MELAG oHG Address Geneststra 5e 9 10 10829 Berlin Country Germany Product oteam sterilizer autoclave Type of device Vacuklav 41 B Vacuklav 43 B Classification Class 2a We herewith declare that the above designated product conforms to the following guideline Appendix of the EC guidelines for medical devices 93 42 EWG Notified body DEKRA Certification Services GmbH Handwerkstra 5e 15 70565 Stuttgart No of registration 90199 Z2 00 The cited medical device is designated with the CE sign since 25 06 2004 Berlin 12 03 2008 General Management Quality Made in Germany Evidence Based Sterilization www melag de
38. f a log In the event of problems with the FTP server it is advisable to send a ping to the IP address of the autoclave 35 Technical Manual Vacuklav 41 B and Vacuklav 43 B Eingabeaufforderung icrosoft Windows AF Version 5 1 2600 CC Copyright 1985 2001 Microsoft Corp N2ping 172 168 57 258 MELAG Start the input prompt at the computer with the FTP server Start gt programs gt Ac cessories input prompt Enter the fol lowing lines Xxx Xxx XXx Xxx 36 ing wird ausgef hrt f r 192 168 57 258 mit 32 Bytes Daten ntwort von 192 168 57 258 Bytes 32 Zeit 83ms ITL 64 ntwort von 172 168 57 258 Bytes 32 Zeit 28ms ITL 64 ntwort von 172 168 57 258 Bytes 32 Zeit 28ms ITL 64 ntwort von 172 168 57 258 Bytes 32 Zeit 27ms ITL 64 ing Statistik f r 192 168 57 258 Pakete Gesendet 4 Empfangen 4 Verloren A Cx Uerlust a Zeltangahen in Millisek Minimum 28ms Maximum 83ms Mitteluert 42ms IM Fig 12 Sending a ping to the IP address of the autoclave on the Windows XP input prompt X IP address of the autoclave If this ping is answered successfully as dis played here then the data transfer between computer and autoclave has been established Cable network or the IP address of the auto clave can be excluded as causes for errors that can occur Messages which can enter in the window of the FTP server Possible cause significance The following line remains on the screen for a long
39. files of the week 05 Log files of the month 06 All program logs 0 Last error log 08 Error logs for the day Y BA SEE for sarting hold the appropriate key Keyl Key2 Key3 Key4 Batch Date Time Program Result 769 488 1226 17 06 06 11 22 Universal program 1225 16 06 06 15 13 Quick program B OK 1224 16 06 06 13 20 Universal program 113 123 456 above right in the display is the index digit slightly sequence for display status to identify the operating situation EI E 3h Ah 1 3 simultaneously press key 1 3 shortly lt 1 Sec ea Tm i NE atest log sorted by sorted by hold key 1 for at least 1 second first first program success Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG Checklist for software update You can employ every CF card formatted with FAT 16 file system for a software update The CF cards delivered from MELAG are already format ted accordingly A CF card is designated as an update CF card if the re quired files for a software update are located in its main directory Files in sub folders are permitted but are ignored by the autoclave Logs or other files in the main directory do not disturb the update MELAG delivers immediately writable update CF cards for the individual autoclave types of the premium class You can tell by the labelling e g 40 B which type of device the CF card is for MELAG also delivers cards which contain the update data f
40. from above for easy filling of the storage tank and to ensure proper ventilation The autoclave works with a cooler located at the rear of the device The function and service life can be impaired if the heat dissipation over the cooler is restricted Therefore we do not recommend incorporating the auto clave this is only possible if sufficient air circulation is ensured Dimensions in parentheses Vacuklav 43 B 58 69 cm Fig 2 Dimensions Vacuklav 41 B 43 B For Feed water supply In case of external feed water supply there is additionally required space for the water treatment unit MELAdem 40 or MELAdem 47 Installation surface Flat and level Place the autoclave on a flat and level surface Load capacity The Vacuklav 41 B weighs without load and without feed water 59 kg The Vacuklav 43 B weighs without load and without feed water 66 kg Electrical connection Power socket 230 V 50 Hz connected load 3400 VA separate fuse protection 16 pro tection from leakage current 30 mA Power cable The power cable is 1 35 m long Log printer If you want to connect a log printer to the autoclave you need another MELAprint 42 socket for its power supply One way drain Wall drain or siphon drain A wall drain nominal DN40 or a siphon drain sink drain is required for the one way drain Waste water hose A 1 m wastewater hose MELAG Art No 39180 can be ordered from MELAG to directly connect the autoclave to the wa
41. gram cycles correspond to the practice relevant require ments of fractionation heating up sterilization pressure discharge drying and ventilation with their parameters of pressure temperature and time The standard function of additional drying provides an option for influencing the program cycle Further changes to the program cycles are possible in individual cases and within the scope of the guaranteed sterilization efficiency but can only be ex ecuted by authorised persons Please consult your specialist dealer or con tact MELAG Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG Electromagnetic compatibility Electromagnetic environment The autoclave is designed for operation in an environment as described below The customer or user must ensure that the autoclave is operated in such an environment as here described ul Warning The abbreviation HF is used for high frequency in the following tables Emitted interference measure Electromagnetic environment guideline ments HF emissions as per CISPR 11 The autoclave uses HF energy exclusively for its internal function Consequently its HF emission is very slight and it is unlikely that adjacent electron ic instruments might be disturbed HF emissions Class B The autoclave is suited for use in all facilities in which are directly connected to a public supply as per IEC 61000 3 2 Emissions of voltage fluctuations flickers Complies as per
42. ial start up of the autoclave the unit needs to be filled once with Notice 2 5 L to fill the double jacket For this reason we recommend you to refill the right chamber of the internal storage tank afterwards immediately Installation material Additional material that can be ordered MELAG Art No Water connection Set MELAdem 40 Water connection Set MELAdem 47 Water connection Set consisting of contained in Art No 09033 and 09034 Feed water inlet fixtures for hose 26x1 replaces pipe fitting for hose 28x1 Hollow screw for feed water inlet fixtures 2x Cu seal 1 8 for Art No 53461 2x Cu seal 1 4 for Art No 53471 replace by twisting Art No 53471 Pressure discharge fitting 1 4 fast screw connection for hose 8x1 screw on at the device One way drain hose PTFE pipe 28 6 cut to size One way drain hose overflow hose 2m Surface mounted siphon with double hose nozzle Double hose nozzle with anti flooding flap for connection to existing sink siphon Water tap 3 4 with safeguard combination additional tap with return flow inhibitor and pipe aerator to attach to an available angle valve Leak monitor water stop with shut off valve and probe Safety combination consisting of return flow inhibitor and pipe aerator according to EN 1717 Table 1 Installation material 11 Installation and setting up 12 MELAG Installation examples Example 1 Standard scope of delivery
43. indows programs here the Text Editor with a certain file extension Your computer does not yet recognize the extensions of the log files ex plained under Question 7 Therefore you have to tell the operating sys tem that a file with for instance the extension PRO STR or LOG is always to be opened with the Text Editor Frequently asked questions FAQ about the software j Die folgende Datei kann nicht ge ffnet werden Datei Beispieldatei END Das Programm von dem diese Datei erstellt wurde muss bekannt sein damit sie ge ffnet werden kann Die Suche kann automatisch online erfolgen oder Sie k nnen manuell ein Programm aus der Liste der auf dem Computer vorhandenen Programme ausw hlen Wie machten Sie vorgehen CO Webdienst F r die Suche nach einem geeignetgseeffiar amm verwenden Offnen mit Wahlen Sie das Programm das zum ffnen dieser Datei verwendet werden soll Datei 410TS0 2 PRO Programme Microsoft OfFice PowerPoint Microsoft Office Ward Sie k nnen nach dem entsprechenden Programm im Web suchen wenn sich dieses nicht in der Liste bzw auf dem Computer befindet Fig 11 Allocation of a file type to the Windows Editor MELAG Example file END represents a log file whose extension END is not yet recog nized by the operating system 1 Double click on the log file in the Win dows Explorer If the extension is not known Win dows XP issues the following message Choose Selec
44. isite is therefore the network adapter connected with the MELAprint 42 The MELAprinf 42 is exchangeable at any time re in stall after an exchange of the network adapter 3 Switch on autoclave in case not already switched on 4 Now first switch on the printer MELAprint 42 or establish power sup ply a signal thereby starts the autoclave 5 Switch off autoclave and switch on again The autoclave then sends the IP address stored in the autoclave as a parameter to the network adapter and stores it If the aforementioned steps do not lead to success the IP addresses set as parameters in the autoclaves and the MELAprint probably no longer belong to a subnetwork see Question 10 because the original settings were changed 33 Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG 13 How is a computer connected directly or via the network to the autoclave Prerequisites 1 Itis best to connect the autoclave into the network with the help of the computer support firm which supports your doctor s office A network card with RJ45 socket is necessary at the computer The autoclave must have at least the software version V2 2 see Question 14 A FTP server program must be available which allows the cre ation of users with edit rights independent of the operating system MELAG provides its own FTP program free of charge Using the MELAG FTP server it is possible to register multiple autoclaves as users simultaneously and receive
45. l Vacuklav 41 B and Vacuklav 43 B MELAG The functions of the keys in the respective operating situation are shown by the labelling in the display Softkeys Furthermore there are functions which are concealed i e not displayed The key combinations available for the user are presented here Above right in the display is the index digit sequence for display status to identify the operating situation 18 What are concealed key combinations and which are available Welcome 607 260 Mee eere ntes ETE 4 A e SZ A C H 217 64 Universal Program SETUP menu SPECIAL menu DOCU menu uag 134 C 2 1 bar 05 30 min Settings JS DOCU menu JS ell Output of log files that stored in MELAG Evidence Based Sterilization Exp instruments textiles Diagnosis qp Vacuum test B amp D test m the autoclav via wrapped and unwrapped Serice conductivity measurement E gt e T WH BS TT 224 B5 CF Card computer printer ej pd o 5 oe sme 1h 4h Additional drying iselectable in the Welcome Tu 200 286 For log output independent of the Pre selection MELAprint Device name IP addr start time 07 Energy saving mode Setting b DIAGNOSIS SERVIC INFO DOCU 784 503 j j respective selectable in the 4 MENU exit and SAVE 136 275 CONTRO RENT automatic logging The 01 Water supply
46. les must be allocated to a text editor in order to open them easily Do not rename log file names Date and time of the log files Serial No and total batch number are found in the log A PC is initially not aware of the extensions of the log files If you perman ently allocate a log file with the corresponding typical file extension to the text editor program then you can always open this file type with a double click from then on see Question 8 A complete encryption of both the serial number as well as the total batch number is carried out directly in the eight place log file name A manual re naming of a file is therefore discernible but not recommended A file name is not allocated twice The log file name ensures a good sortability of re cords Date and time of the log files in the Windows Explorer are identical with the date and time of the program start provided that these were saved on the respective medium by immediate printout For later collected output on a medium or for sending by e mail this information is lost It is not necessary to know the encryption within the name of the log file since by double clicking on the file the contents and hence also the serial 29 Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG 30 file Total batch number must be entered when the circuit board is exchanged The program MELAview V2 0 for display ing editing and printing log files Regular transfer of l
47. of your autoclave An update with an improper parameter module can lead to im plausible fault messages Always update the modules 3 to 5 of the user interface Ul together The structure and texts of the UI necessitate each other When nonsensical texts appear in incorrect areas of the displays unrelated Ul modules can be the cause How can change the language of the user inter face of the autoclave The autoclave offers the selection of two languages The two languages contained in the autoclaves can be set by means of the adjustable digit in the Menu Item 06 Language setting in the SETUP menu If you want to replace the two languages by other languages carry out an update with these languages The update file names necessary for this purpose are BLLxxxkk mot and B2Lxxxkk mot Always update the user interface completely i e with BUSxxx mot in one version In this case xxx is the version of the user interface which al ways must agree and kk is the international motor vehicle identification of the desired language country Every combination of language files is technically possible but neverthe less please employ only the following language combinations Update module Module 4 1 language Module 5 2 languages Set digit in SETUP Menu 06 Language setting Bem 98 e pbp Great Britain Table 22 Combinations to be observed in setting up the languages MELAG 39 Technical Manua
48. og data from CF card to the PC With MELAview V2 0 you can Display complete protocol lists Sort and filter files Statistically evaluate data automatically Save preferred paths Log files can also be read with other text editors Link with the Windows Editor number and total batch number can be seen The prerequisite is the above mentioned allocation of the log file to a text editor see Question 8 In the rare event that a circuit board must be exchanged the total batch number must be entered This is possible for authorized experts in the SERVICE menu How can I open and print a log file MELAview MELAview V2 0 is a program developed by MELAG for displaying and sorting sterilization logs Furthermore you have the option of logging graphic logs during a program run Text and graphic logs can be printed from MELAview V 2 0 or exported in various data formats For test purposes you can display DUMMY logs without a license code The complete autoclave protocol function of MELAview V2 0 can only be used with a license which has to be purchased An installations assistant leads you through the installation of the program The program MELAview V2 0 does not have any administration functions This means for example that logs are not automatically synchronized with the log storage folder on your computer by a CF card The MELAview program has no administrative functions This means that the log files are not automa
49. or all autoclave types of the premium class They are recognized by the labelling premium ALL Before inserting these cards into the card slot of the autoclave you must copy the appropriate parameter file for your autoclave from the folder parameter into the main directory The suitable file for your autoclave type can be clearly recognized by the file name If your autoclave is already connected to a network via a FTP server Attention please ensure that With versions above 2 4 the password for the FTP server consists of MELAG five adjustable digits standard MELAG12345 If your auto clave is already connected to a network via an FTP server the previous password MELAG in the FTP server program must be changed to the new password Otherwise no further protocols will be transferred after the update It is well known that some older CF cards with 256 MB memory capacity Notice can cause file system problems e g implausible files on the CF card For this reason and due to the large memory requirements please purchase MELAflash CF cards with 1GB memory capacity or more Do you have an update CF 1 yes no 2 card continue to 2 Order an update CF card from MELAG or configure an update CF card yourself continue to 2 Does the existing update of 2 You can verify the version level or download the most current version via the CF card contain the internet Please check the download area from our website www melag de
50. r Water treatment unit MELAdem 40 or MELAdem 47 set up according to installation instructions In case of installing a water treatment unit Autoclave was set in the user menu on water supply extern It was pointed out that demineralized water with a minimum quality according to VDE 0510 must be used as feed water and the items to be sterilized must be clean and free of cleanser and disinfectant residues OOOO Install wastewater connection depending on installation variant O wastewater is collected in the internal storage tank no wastewater connection O One way drain connected to the existing siphon of the domestic water supply or the double chamber wastewater trap from MELAG Align the autoclave For fault free operation the autoclave must be set up horizontally with the help of a water level located close to the sterilization chamber flange Then depending on the type of autoclave the front feet of the unit must be unscrewed by about three or five rotations in order to give the autoclave a slight backwards tilt O Vacuklav 41 B front feet of the unit screwed out 3 rotations O Vacuklav 43 B front feet of the unit screwed out 5 rotations Conduct and record vacuum test with empty chamber and Universal Program with 1 5 kg load instru ments O Vacuum test performed with empty cold chamber Leakage mbar min O Universal Program successfully executed with about 1 5 kg load instruments O A printout of the
51. rectory in the main directory is created on the CF card Direct transfer of the log on a computer via the network and using the MELAG FTP server allows you to determine directly in the FTP server where on your computer the device directory with log files is to be saved For every type of log output immediate printout after run cycle or transfer of multiple log records at once the autoclave also verifies the storage me dium and automatically creates a directory of the device and the month if none exists Do not rename the directories since then the logs would be stored both in the renamed directory as well as in the device directory automatically recreated by the autoclave If multiple log records are outputted on one and the same storage medium then in the device directory a directory double is created in which these log records are stored once What do the numerals and letters in the directories and log file name mean Position 1 2 3 4 5 6 7 8 8 3 D 0 J 0 B M Serial number Yearof Type Manuf No manuf B Manuf No and total batch numbers are Batch converted according to the same principle A small Excel application facilitates the conversion successful program Graphic log malfunction malfunction in standby system log status log abbreviation legend demo log demo malfunction Table 17 EXOamaton of the mumerd and letters in the directory and log names based on an Sane Log fi
52. s and system logs that are still not archived As of firm Attention ware Version 2 at an update an appropriate warning message appears which you acknowledge with YES if you want to continue the update pro cess yes no continue to 5 Enter the program logs and if necessary the mal function status and system logs on the CF card continue to 5 Is your autoclave already 5 yes no FONNO TEN ONAE COMPUTE gt Note all IP ad continue to 6 network dresses or note them from the status log Re enter the IP addresses in the autoclave after the update see Ques tion 10 continue to 6 Execute update 6 1 Plug the update CF card correctly in the card slot before switching on the device The CF card must be easily inserted completely without force with the appreciably raised handle corner edge pointing to the left towards the boiler 2 Switch the autoclave on The question appears mainboard firm ware update WARNING Proceed Never switch off the autoclave in this situation If you want to answer with NO first remove the CF card from the card slot despite lighted LED If you answer with YES the update process begins automatically 3 Appropriate references appear in the display in English An up date of the complete software package takes about 5 minutes The illumination of the LED can be interrupted between the download Attention ing of the files The update is only terminated when the Welcome pic ture app
53. sion at 135 C per Gaussian law of propagation ca 0 47 K Table 12 Precision including drift of the entire measuring chain of the temperature measurement after 5 years Precision lat pure addition of indiv errors 0 70 96 corresp to 28 0 mbar corresp to ca 0 30 K steam temp Precision per Gaussian law of propagation 0 41 96 corresp to 16 5 mbar corresp to ca 0 18 K steam temp Table 13 Precision including drift of the entire measuring chain of the pressure measurement after 5 years MELAG 21 Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG Nominal value tolerances Tolrenaces for nominal values to be achieved by Premium autoclaves Universal program Quick B Prion pr Gentle pr Quick S 4 same meaning as in Univers tep P Tol Tol 1600 1300 1600 1300 1600 1300 1600 1300 1600 1300 500 1600 1300 180 1800 1300 200 1900 1300 400 F43 1700 HO1 2750 2850 3080 3170 1300 Table 14 Tolerances for nominal values in the program cycle O o o NI E Qo o N N Conditioning 2 A 2 Cp o AL A NO NI SF13 N ep TI OO ae Tl Ti Q2 I NO Fractionation SERE T TI IS AT IN of NI E aL O N 7 D o O N S CO U Qo gt o o 22 Technical tables Pressure Time Charts iI l l T smod e e Sra z EIBSIS ISI EIS S IF 2 213 12 eru in i ln amp lv i o 46
54. ste water i e the pres sure discharge goes directly into the siphon of the domestic water supply One way overflow hose on If you close the one way overflow hose of the autoclave at the siphon of the siphon the domestic water supply you need a 2 m wastewater hose Art No 36585 which you can also order from MELAG The drain must be located at least 30 cm beneath the autoclave and be in stalled dip free with continuous descent 10 Installation and setting up MELAG Supply with feed water Feed water one way system Since the contamination of feed water in autoclaves using a water circula tion system regularly leads to early damages to the autoclaves and instru ments the autoclave works in the gentle yet effective one way water sys tem This means that it uses fresh purified feed water for every sterilization run The autoclave gets the feed water either from a water storage con tainer which the practice team has refilled e g with distilled water from the MELAdest 65 Or it gets the feed water fully automatically from the water treatment unit MELAdem 40 or MELAdem 47 Quality of The quality of the distilled or demineralized feed water for the steam feed water generation must be at least VDE 0510 Provide feed water supply Before the initial start up of the autoclave the right chamber of the internal from internal storage tank storage tank of the autoclave must be filled with feed water up to the max imum marking At the init
55. t D eM UD I E 16 Device andnstallati r del acd io t a caca dad xa Seas noo vF ites duns n aea kara aen dact cade teria Resa eal c sosa ca Rs ved apud C qesd cin UE das da 16 EKO CULS WOM dem p EUER 17 COMI AS USO TING oiseau dori tect atest deena ead cit ie er edad a dmi gotten eens 19 Counter PO ACIING Se ste crises a wes a tease oh ct eine dal deer of Sete aus ase ke e niente cee ee LN Sua 19 Program MOCINCALION REN REURCRNUNT cT 19 El ctr magn tic compatibility Le 20 Electromagnmnelie enviFODEmiglD ncs uscdbsate re nazi ea Nera RenseMU rns duet sorde dad ua or ode ca cU tace pau a saxa Riu Veo w av ra Gua cd 20 Recommended protective GiStAnCes cccccssccccsssceccssececeeececseseecusaeeeeeesecsueaecessueeeseeaeesseueeesseeseeesaesseeseeegass 21 Technical TAOS iid iit onere a fele see sencanaedacdeemwencncanars E a a E 22 Precision and drift behaviour Sensors ccccceecccceesescecceeeecececeueececsauuceescsauueeesseeeeeesseaueeeessueeeeessaseeseneness 22 Precision and drift behaviour Measuring nalla races bes een fausoxtaibaois qi Eee Eod ran EE RAE NEU Res ta CUP d sa T trade civ unde pos va D dnd cac adr ta LUI aL Ph Rute 22 Precision and drift after 1 Year cccccccsecceccssseeeccsessececeeeeeeeceeseceesseeseeeecsueeeeesseeceesseeseeeessueeesessesesessnagsesens 22 Precision and drift after 5 Years ccccccccssssceccceseseececeseeeccsaeuceeece
56. t program from a list and confirm with OK Select the Editor from the list of pro grams in the window that opens It is im portant that you set a checkmark on A1 ways open this file type with the selected program so that the operating system will recognize the ex tension in the future as well Confirm with OK From now on you can always open files with this extension by double clicking in the Windows Editor 9 What do the terms IP address and subnetwork mean IP address The IP address is the identification of the respective computer in a net work expressed in numbers and unambiguously identifies the respective computer or autoclave with four number blocks e g 192 168 88 8 Subnetwork and IP address Every IP address is divided into a network and an appliance part host part The division is carried out by the network mask subnetwork Sub Net Mask The network part of the IP address must be the same for devices to be able to communicate with each other on the network With a network mask 255 255 255 0 the most frequent the first three figures e g 192 168 88 x must match The device part of the IP address is assigned individually and only once The first network itself and the highest broadcast device address may not be assigned here 10 How can I verify or change the IP addresses stored in the autoclave The IP addresses are saved in the autoclave as parameters for the follow ing devices 31 T
57. ternatively straight Feed water filter MELAdem Double chamber waste water trap MELAG Art No 26635 Wall drain NW40 available on site Double hose nozzle with anti flooding flap MELAG Art No 37400 contained in the surface mounted si phon with Art No 37410 Concentrate drain MELAdem 47 Inlet hose feed water One way overflow hose MELAG Art No 36585 MELAdem 47 Water tap available on site Power cable Leak monitor water stop with shut off valve and probe MELAG Art No 01056 optional recommended with fixed water connection Ethernet 3 Data connection can be retrofitted Ethernet 2 Data connection Installation as in example 2 MELAdem 40 The wastewater drainage is automated here The one way overflow hose 12 is connected to the one way drain of the autoclave and connected over the double hose nozzle 9 with the double chamber wastewater trap 7 In the case of direct connection of the water treatment unit to the do mestic water supply we recommend the additional Installation of the leak monitor water stop valve with shut off valve and probe 16 Fax 49 0 30 75791199 Telephone 49 0 30 7579110 MELAG Record of installation and setting up Please send to MELAG Dear Madam Sir within the scope of Quality Assurance we are oblig MELAG Medical Technology ated in cooperation with you the responsible spe cialist MELAG dealer to install this MELAG auto Geneststrafte 7 10 clave at th
58. that all the Notice program records stored in the autoclave are lost with the firmware update Please therefore be sure to back up any not yet archived program logs and if necessary also the malfunction status and system logs As of the firmware Version 2 the warning appears at update Mainboard Firmware Update WARNING Proceed Acknowledge with YES if you want to continue the update process If no update should take place in no case switch off the device In this situation despite lighted LED you can remove the CF card from the card slot of the autoclaves Then press the NO button Short form of the checklist 1 Do you have a suitable CF card for the device type for software update 2 Doesthe existing update of the CF card contain the most current software version Technical Manual Vacuklav 41 B and Vacuklav 43 B MELAG 38 i g A Attention Boot loader update is only necessary in exceptional cases An update process is forced by the boot load update Every CF card formatted with FAT16 The files for a software up date must be stored in the main directory for an update CF card 16 3 Does the autoclave have the latest version 4 Have you archived all the logs still stored in the internal storage of the autoclave e g on the CF card 5 Is your autoclave already connected to the computer network 6 Plug the update CF card correctly in the card slot before switching on the device the CF card must
59. the memory capacity of the CF card see Table 16 page 14 9 Confirm the entry of the format command and if desired enter a name max 8 characters for the CF card In every log paper printout or file the total batch number is cited in the log header capacity of format instruc the CF card tion to be entered By adjusting parameter A you for instance prevent Windows XP from otherwise automatically formatting with FAT16 or FAT32 depending on the card size We recommend using MELAflash CF cards with a minimum of 1GB memory capacity in accordance with the latest tech nical standards 2GB format X A 32K 1GB format X A 16K Table 16 Format Instruction to be entered depending on the memory capacity of the CF card Frequently asked questions FAQ about the software After log output in the device directory on all memory media When using the MELAG FTP server Do not rename directories Directory doubled MELAG Where do find the outputted logs After a log output a directory is automatically created with the encoded serial number of the respective autoclave the name of the directory con sists of five characters which are identical to the first five characters of every log e g 43D0J Under this directory there are subdirectories with the months of the log creation e g 12 2008 for December 2008 The subdir ectories contain all the logs created by the autoclave in the respective month The device di
60. the short and simultaneous pressing of the keys 2 and 3 from an ar play bitrary display display the autoclave status The status display disap pears after 30 seconds and the initial screen appears again Check within the status display Status display example Line What inthe You check example Manuf No B1333 may not change and may never be precisely 1000 01 Type of 41 B Conforms with the type of your autoclave unit 41 Version JAre the versions of all four software modules in 429 No of the fact updated to the newest version V2 4 software WEN 13 module Frequently asked questions FAQ about the software 01 MEL AG Vacuklay 41 B Year 2006 05 internal storage 10 free 108 06 output media CF Card Computer Printer lmmed Format automatic logging YES YES NO YES 00001 not yet alread 1 5 5 4i4 09 Conduct 11 uis cm 11 11 Rins val 499 piSl cm 991 333x Version Softwaremodule Updatefile Date 11 2 431 Firmware FW Nov 21 2008 10 23 41 12 v2 430 Parameters P41 B 26 11 2008 13 v2 4531 BO BUS B1L B2L 11 12 08 14 Display F DFVY Feb 24 2006 09 41 35 15 v2 20 Display symbols DS 08 22 2008 18 17 02 Table 20 Check the autoclave software e g after an update If while the status is being displayed you simultaneously press the keys 2 Notice and 3 again within 30 seconds then you can exit the status display only by switching off the autoclave Description File name of Siz
61. tically synchronized from a CF card with the folder for log archiving on your computer We therefore recommend that you regularly weekly or monthly transfer the data from the CF card to your PC To do this create a folder on the hard drive of your PC named for instance MELAG Autoclave Logs where you can save and archive the log files You can copy the log files from the CF card to the PC using the Windows Explorer MELAview V2 0 is able to display complete log lists You can sort by double clicking on the headers within the list and fitter the files via the se lection field below A statistical analysis of the logs is carried out automatically number of suc cessful programs program type etc You can save preferred paths by selecting the path and right clicking the folder symbol You can record graphic logs during a program run using MELAview V2 0 and display them as curve diagrams in MELAview V2 0 You can export the graphic logs from the program in various data formats e g for archiv ing All log files are text files in ASCII format which you can read edit and print with the simplest text editors of every operating system or with text processing or table calculation programs Graphic logs can only be displayed with MELAview V2 0 An operating system uses the file extension to recognize which program it should use to open or edit the file Using the example of the Windows edit or you will learn below how you link other W
62. toclave sterilizes on the basis of the fractionated vacuum A membraneous pump is used to create the especially deep vacuum Thus the autoclave can be immediately put into operation without additional in stallation work apart from providing the necessary power supply For the optional connection of the one way drain and an external water treatment unit please follow the water main and general information for the proper in stallation which must be observed when setting up the device Removal from the packaging Lift the autoclave out of the carton with the carrying strap To remove the carrying strap unscrew the four screws on each side of the housing Retighten these screws firmly without the washers Keep the car rying strap and the washers After switching on the autoclave and before initial start up open the door and remove the trays and the accessories from the chamber To do this you must go into door mode Press the Door button on the Welcome start screen afterwards the door can be opened After 5 seconds of inactivity the display automatically switches back to the main menu The autoclave then begins to suck in the feed wa ter needed for the sterilization which triggers an error message Installation and setting up MELAG Space requirements The space requirements for the autoclave corresponds to its dimensions plus at least 5 cm on the side and 10 cm at the back side The autoclave should be freely ac cessible
63. ts such as E065 for messages cautionary notes or fault mes sages Output of the error texts in the log Door mode door button after switching on permits the door opening without starting up the autoclave Door motor functions and messages integrated for Vacuquick File names of the update modules now permit both recognition of ver sion as well as type and language Blocking skipping of programs with a parameter change is possible Access to DEMO mode and service counter is simplified DEMO mode is recognizable during program sequence and in the logs inverse texts Message only for unwrapped instruments also appears in the DEMO mode No feed water cautionary notes or fault messages any longer in the DEMO mode Total batch number from service after an exchange of circuit boards can be set Fault messages defined and display texts optimized What does the lighting of the LED next to the card slot signify During boot loader phase device ON After CF card was inserted in the card slot No firmware present occurs e g after power loss or during an update process if for instance the update CF card is too rapidly removed in this case a CF card with firmware must be plugged in during the boot loader phase see Question 15 Page 37 so that the device can run again After apparatus is switched on with inserted update CF card which is then automatically recognized The light
64. y 2008 Responsible for the contents Engineering Department MELAG Medical Technology Geneststra 3e 7 10 10829 Berlin Germany E Mail info melag de www melag de 2008 2009 MELAG Berlin Document Melag Vacuklav 41B 43B TechnicalManual v3 doc Revision 3 09 1793 Subject to technical changes Technical Manual Vacuklav 41 B and Vacuklav 43 B CONTENTS meer m 2 DEVICE VICW c M M 8 DEVICE VIEWS FICK DIS Play M es 9 Installation and setting UD reci ie eo to cates adit bad cate e eser ecuador Sci esr Epes RE Pasa pesa V Deere inva c dr tese Duos 10 Removal trom the packaglrig o eie denis tese ette usc dia eU taie a a Uva d ete deste ee 10 wjer eizu iso BISTRO ETE T m ooo ER 11 WS tallatiOne SUT ACC sere a 52 T P 11 EISCtni Call COMME CUO MN sas ict ate E NR 11 SOSA renee ei Se et EM een ne ee ee ee ee ee eee ee 11 SUD DIY WIN gt TECC WAE e P 12 HASAN ATION IMAte Malta asa rence cedine ance A IU m T S 12 Installation example S 5 atate Tad ats a Nt ee a Mica ee Tala t oe dud aia A 13 Record of installation and setting Up ccccccessseeeeseseeeeeeeeeneeeeeeeneeeseeesseeseneeseeeseaaaaeeeeeaaseeessaeeseeeseasseesssnnesenenes 16 ledsesera ioMMELA xu haa tn adam ete rib elec Eee ae D

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