MELAG Vacuklav 41-B, Technical Manual

Page 1: ...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 ...

Page 2: ...ormity 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 Vali...

Page 3: ...se send to MELAG 16 Device and installation data 16 Executed work 17 Contrast setting 19 Counter readings 19 Program modifications 19 Electromagnetic compatibility 20 Electromagnetic environment 20 Recommended protective distances 21 Technical tables 22 Precision and drift behaviour Sensors 22 Precision and drift behaviour Measuring chain 22 Precision and drift after 1 year 22 Precision and drift ...

Page 4: ... Steam 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 I of the EC guidelines for medical devices 93 42 EWG Notified body DEKRA Certification Services GmbH Handwerkstraße 15 70565 Stuttgart No of registration 50199 Z2 00 The cited medical device is designated w...

Page 5: ... 10 10829 Berlin Country Germany Product Steam 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...

Page 6: ...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 instruments Type A wrapped and un wrapped Hollow bodies instruments Type B wrapped and un wrapped Instructions on load quantities and loading variants are set fo...

Page 7: ...Technical Manual Vacuklav 41 B and Vacuklav 43 B Evidence Based Sterilization www melag de 5 ...

Page 8: ...ch Institute of April 2006 Manufacturer MELAG oHG Address Geneststraße 9 10 10829 Berlin Country Germany Product Steam 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 MELAcontrol Berlin 12 03 2008 ...

Page 9: ...e Ethernet 1 Data connection Reset button overheating protection Front foot of the unit adjustable behind covering Back side 11 12 13 14 15 16 17 18 19 20 21 22 23 Tank filler cap Ethernet 2 data connection Ethernet 3 data connection can be retrofitted Power cable Safety valve chamber Sterile filter Safety valve double jacket Emergency overflow One way drain Connection pressure discharge Purified ...

Page 10: ...ssible from the side Ethernet 1 Data connection Reset button overheating protection Front foot of the unit adjustable behind covering Back side 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Tank filler cap Ethernet 2 data connection Ethernet 3 data connection can be retrofitted Power cable Safety valve chamber Sterile filter Safety valve double jacket Emergency overflow One way drain Connection pressu...

Page 11: ...ted 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 ...

Page 12: ... 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 MELAprint 42 If you want to connect a log printer to the autoclave you need a...

Page 13: ...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 09033 Water connection Set MELAdem 47 09034 Water connection Set consisting of contained in Art No 09033 and 09034 25655 Feed water inlet fixtures for h...

Page 14: ...er 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 Fig 3 Direct feed water supply from the internal storage tank 1 Tank filler cap 2 Sterile filter 3 Safety valve chamber 4 Safety valve double...

Page 15: ...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 the s...

Page 16: ... MELAG Art No 26635 8 Wall drain NW40 available on site 9 Double hose nozzle with anti flooding flap MELAG Art No 37400 contained in the surface mounted si phon with Art No 37410 10 Concentrate drain MELAdem 47 11 Inlet hose feed water 12 One way overflow hose MELAG Art No 36585 13 MELAdem 47 14 Water tap available on site 15 Power cable 16 Leak monitor water stop with shut off valve and probe MEL...

Page 17: ...equisite 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...

Page 18: ...eet 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 program cycle was created with th...

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Page 20: ...autoclave in the INFO Menu Counter Readings To get to the menu simultaneously press the keys 2 3 Program modifications The autoclave program 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 Additional drying The standard function of additional drying pr...

Page 21: ...he flooring is furnished with synthetic material the relative humidity must be at least 30 Rapid transient electrical disturb ances bursts as per IEC 61000 4 4 2kV for mains cables 1kV for input and output cables 2kV for mains cables 1kV for input and output cables The quality of the supply voltage should corres pond to a typical business or hospital environment Surges as per IEC 61000 4 5 1kV pus...

Page 22: ...ning 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 3 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 ...

Page 23: ...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 at pure add...

Page 24: ...0 pressure release SF22 180 30 30 380 evacuate SF23 1800 100 20 steam entry SF31 1300 20 50 pressure release SF32 200 30 30 evacuate SF33 1900 100 20 steam entry SF41 1300 20 50 pressure release SF42 400 30 30 evacuate SF43 1700 100 20 1500 steam entry SH01 2750 60 60 1850 keep steam entry SH02 2850 60 60 1950 keep control SS01 3080 60 60 2080 sterilization start SS02 3170 60 60 2150 sterilization...

Page 25: ...Technical tables Pressure Time Charts Fig 6 Pressure Time chart for Universal Program 134 C and 2 1 bar Fig 7 Pressure Time chart for Quick Program B 134 C and 2 1 bar 23 ...

Page 26: ...Technical Manual Vacuklav 41 B and Vacuklav 43 B Fig 8 Pressure Time chart for Quick Program S 134 C and 2 bar Fig 9 Pressure Time chart for Gentle Program 121 C and 1 1 bar 24 ...

Page 27: ...ion 10 mg L Silcon SiO2 1 mg L Iron 0 2 mg L Cadmium 0 005 mg L Lead 0 05 mg L Heavy metals except for those named above 0 1 mg L Chlorides 2 mg L Phosphate 0 5 mg L ph value 5 7 Colour colourless clear without sediments Hardness 0 02 mmol L Table 15 Minimum requirements to the feed water following the EN 13060 Appendix C 25 ...

Page 28: ...s 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 Version V2 2 I...

Page 29: ... defined and display texts optimized 2 What does the lighting of the LED next to the card slot signify short lighting up 1 s During boot loader phase device ON After CF card was inserted in the card slot Blinking every 0 5 s 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...

Page 30: ...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 ...

Page 31: ...on 1 2 3 4 5 6 7 8 X X X Example 8 3 D 0 J 0 B M P R O Meaning Serial number Year of manuf Type Manuf No Batch Log file extension Explana tion 6 2006 7 2007 8 2008 9 2009 A 2013 B 2014 0 40 B 1 41 B 3 43 B 4 44 B 8 13 B 9 14 B Manuf No and total batch numbers are converted according to the same principle A small Excel application facilitates the conversion PRO GPD STR STB LOG STA LEG DEM DES succe...

Page 32: ... 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 With MELAview V2 0 you can Display complete protocol lists Sort and filter files Statistically evaluate data automatically Save preferred paths MELAview V2 0 is able ...

Page 33: ...e 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 ...

Page 34: ... Computer 192 168 40 140 Default setting ex factory MELAprint 192 168 40 240 Default setting ex factory Client3 192 168 40 144 not employed or not modifiable Gateway 192 168 40 244 Not relevant within a network sub network mask 255 255 255 0 Possibly take over from the customer network Table 18 IP addresses saved in the autoclave 32 ...

Page 35: ...he MENU Exit and SAVE and also only then are they correctly visible 11 How do I ascertain the IP address and network set tings of a PC in Windows XP Determination of the IP ad dress of a PC under Win dows XP 1 Start Settings Network connections LAN connec tion Register Network Support Start IP Address 2 For instance you can discern whether a PC is integrated into a dy namic network Start Settings ...

Page 36: ...rd Attachment SETUP Menu 02 Automatic logging key 4 EDIT key 4 CONTINUE with navigation keys to LAN TCP IP FTP key 4 EDIT with navigation keys to FTP Server Password Attach ment key 4 EDIT digits inversely highlighted and then can modi fied with the keys Determine computer for FTP server program 2 Since of the autoclave itself is furnished with a hub a network en sues with the direct connection of...

Page 37: ...mework 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 Notice Enter the four digits of the year of construction as the ...

Page 38: ... 100 USER 200440 B1000 is logged in 14 03 52 192 168 40 100 USER 200440 B1000 C Docu ments and Settings Admin own files protocols 14 12 22 192 168 40 100 QUIT Successful handshake between autoclave and FTP server in which however no autoclave protocol was im ported Table 19 Possible messages in the window of the FTP server and their significance 14 How can I verify the version of the autoclave sof...

Page 39: ...checklist for software update page 41 Carrying out the update procedure is uncomplicated It cannot cause an autoclave malfunction Device specific numbers such as the serial num ber overall charges and maintenance counter are not changed Notice Ensure that the autoclave device type and the parameter file of the up date CF card correspond The parameter update files of the V 2 4 do not exceed the IP ...

Page 40: ... when verifying the update result 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 An update process is forced by the boot load update For the boot ...

Page 41: ...sical texts appear in incorrect areas of the displays unrelated UI modules can be the cause 17 How can I change the language of the user inter face of the autoclave In general the choice of two languages is possible 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 th...

Page 42: ... 3 Pre selection start time selectable in the respective program 4h 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 slightly 1h Additional drying iselectable in the respective program Access to SETUP Menu without messages about 5 seconds no process...

Page 43: ...e FTP server program must be changed to the new password Otherwise no further protocols will be transferred after the update Notice It is well known that some older CF cards with 256 MB memory capacity 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 yo...

Page 44: ... 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 beg...

Page 45: ...yes End no Carry out update process once again look for ap propriate error in FAQ or contact MELAG 43 ...