MELAG Vacuklav 24 B+ Technical Description Download Page 57 | Manualshive

Page: 57 / 57

MELAG Vacuklav 24 B+ Technical Description Download Page 57

57

Appendix B – Symbols on the
autoclave

The manufacturer of the apparatus declares with the accompanying sticker
that the medical device corresponds to the basic requirements of the
European Standard EN1717 – "Protection of drinking water from
contaminants…."

The symbol of the struck out trashcan identifies a device that may not be
disposed with domestic waste. An appropriate and competent disposal
must be carried out by the marketing party.

With the designation of an apparatus with this symbol, the manufacturer
furthermore declares that he satisfies all requirements of the law
concerning the release, withdrawal and environmentally compatible
disposal of electric and electronic appliances.

With the CE sign CE 0124, the manufacturer declares that the medical
device corresponds to the basic requirements of the German Medical
Device Guideline. The four-digit number means that an approved
certification body (here:DEKRA) monitors the product certification.

With the CE sign CE 0035, the manufacturer declares that the medical
device corresponds to the basic requirements of the German Printing
Device Guideline. The four-digit number means that an approved
certification body (here: TI Rheinland-Berlin/Brandenburg) monitors the
product certification.

«
...
55
56
57

Summary of Contents for Vacuklav 24 B+

Page 1: ...re than 400 000 MELAG units worldwide attesting to the high quality of our sterilizers which are exclusively made in Germany This autoclave has also been manufactured and tested according to the most stringent quality criteria Nevertheless please read the Technical Description carefully before the initial start up of the device The long term serviceability and the retention of value of your autocl...

Page 2: ...9 Berlin Germany Telephone 49 0 30 757911 0 E mail info melag de www melag de 2007 MELAG Berlin Document BA_1_GB_24B _30B doc Revision 1 07 829 Subject to technical changes For physicians physician s assistants and service personnel Please read this Technical Description before you start operation of the autoclave The instructions contain important safety precautions Make sure to keep the Technica...

Page 3: ...xplanation Danger Risk to health Indicates a dangerous situation which if not avoided could entail slight to life threatening injuries Warning Observe without fail Indicates a dangerous situation which if not avoided could entail damage to the instruments the practice equipment or the autoclave Important information Indicates important information Example of emphasis Meaning Explanation Conductivi...

Page 4: ...ents e g RKI Robert Koch Institute and DGSV German Society for Sterile Supply Only use wrapping materials and systems which are suitable for steam sterilization according to the manufacturer s information Program termination Take heed that when opening the door after terminating a running program hot water steam can escape out of the chamber depending on when the program was terminated Depending o...

Page 5: ... Remove sterilized items 27 Storage of sterilized items 27 Chapter 5 Logging 29 Batch documentation 29 Set date and time 30 Use printer as output medium 30 Employing MELAflash as output medium 32 Computer as output medium 32 Automatic immediate log output 32 Output the logs subsequently 33 Display printer memory 34 Read log files correctly 35 Chapter 6 Maintenance 37 Cleaning 37 Avoid formation of...

Page 6: ... instruments and textiles with this autoclave like the foregoing instrument sterilization is only to be done by competent personnel Only use instruments wrappings and textiles which are suitable for steam sterilization according to the manufacturer s information In case of non observance the consequences can entail damage to the autoclave and or to the items to be sterilized User benefit Universal...

Page 7: ...essure and temperature in the sterilization chamber at all times and its door locking system does not permit opening the door when there is overpressure in the chamber A process evaluation system is integrated in the electronics of the autoclave It monitors the process parameters such as temperature time and pressure during a program It monitors the parameters with respect to their limit values at...

Page 8: ...ir leak X X X X Empty chamber test X X X X Solid load X X X X Porous partial load X X X Porous full load X X X Hollow body B X X X X Hollow body A X X X Simple wrapping X X X X Multiple wrapping X X X X Drying solid load X X X X Drying porous load X X X Sterilization temperature 134 C 134 C 121 C 134 C Sterilization pressure 2 bar 2 bar 1 bar 2 bar Sterilization time 5 min 3 5 min 20 min 20 min X ...

Page 9: ... report Pressure device directive certificate Record of installation and setting up 1 mounting for trays or cassettes 1 waste water hose PVC fabric 2 metres 1 pressure hose water feed 2 5 metres 1 TORX key for removing the carrying strap 1 tank filter key Guide sleeve Feed water connection Dual chamber siphon Feed water container with intake hose if delivered without MELAdem Lever for emergency un...

Page 10: ...cy switch on of the vacuum pump 8 9 10 Device fuses 2x 16A gRl Reset button for protective motor switch Reset button for overheating protection hidden behind the white cover Back side 11 12 13 14 15 16 17 Safeguard combination according to EN 1717 Safety valve Sterile filter Cooling water inlet 3 4 outside thread Cooling water outlet 3 4 outside thread Power cable Feed water intake for external wa...

Page 11: ... 22 litres Vacuklav 30 B 25 cm 35 cm 18 litres Mountings for the load The autoclave is always delivered with a mounting to hold trays or cassettes The mounting A is standard and can hold either five trays or three standard tray cassettes rotated by 90 Fig 3 Mounting A The mounting B can hold four standard tray cassettes or four trays Fig 4 Mounting B The mounting D can hold two high cassettes e g ...

Page 12: ...ater storage tank from MELAG has a capacity of maximum 11 5 litres This quantity of feed water suffices for up to 25 sterilizations Distilling unit MELAdest 65 With the MELAdest 65 distilling unit you can produce feed water in the practice cost effectively Feed water with water treatment unit A water treatment unit is connected to the domestic water supply It produces the feed water required for g...

Page 13: ...ons per day and the respective loads Both MELAG autoclaves can be supplemented with a water treatment unit NOTICE Please first consult with MELAG if you would like to employ water treatment units of other manufacturers Supply with cooling water The pump for the vacuum creation is cooled with water The cooling water inlet of the autoclave is connected to a customer side faucet for this purpose The ...

Page 14: ...rea must have a radius of at least 1 5 metres Damages to the autoclave and or injuries can occur in case this precaution is not observed Set up location requirements Location Set up the autoclave in a dry and dustproof location The air humidity should be 30 to 60 and the ambient temperature 16 to 26 C Warning Without fail keep the specified distance free to the surrounding surfaces at the sides an...

Page 15: ...er storage tank to sunlight This way you avoid algae formation The maximum suction height from the external storage tank is 1 5 metres Space requirement for water treatment unit MELAdem 40 can be directly hung on to the autoclave on the side The attachment can be next to the autoclave or above or below the autoclave MELAdem 47 Attachment next to the autoclave or above or below the autoclave e g lo...

Page 16: ...ted below the autoclave NOTICE The waste water hose must be laid dip free with continuous descent For waste water paths which are longer than two metres we recommend a fixed laying of HT high temperature piping by a specialised installation firm Observe the following precautionary measures when handling the mains cable and power plug Danger of injury Never splice or modify the mains cable Never be...

Page 17: ...ting up NOTICE As documentation of proper setting up installation and setting up as well as for your warranty claim the record of installation must be filled out by the person responsible and a copy sent to MELAG Switch on autoclave Switch on mains Turn the mains switch on to power the autoclave page 10 Fig 1 4 After switching on After switching on the autoclave with the mains switch the display s...

Page 18: ...op valve from MELAG Art No 01056 Provide feed water If you are employing a water storage tank for the feed water and the filling level lies below the MIN marker on the canister fill up the water storage tank The feed water must have a quality at least according to VDE 0510 see page 38 Use qualitatively high grade water If you employ a water treatment unit e g MELAdem 40 or MELAdem 47 and the water...

Page 19: ...ing results can result Unsterile textiles could be the consequence This could mean endangering the health of the patient and the practice team Instruments Observe the following instructions for treating used and brand new instruments Danger of infection Follow without fail the instructions of the instruments manufacturer for treatment and sterilization and observe the relevant standards and direct...

Page 20: ... as clear plastic sterilization packages paper bags sterilization paper textiles fleece Closed sterilization containers Preferably use sterilization containers made of aluminium Aluminium conducts heat well and thus accelerates drying When using closed sterilization containers observe the following instructions for holding the sterilizing materials Warning Closed sterilization containers must be e...

Page 21: ...ization then it might be that the wrapping was too small If this is the case re wrap the instruments and sterilize them once again The packaging should be filled to or the spacing for the sealing seam at 3 cm If the welding seam tears open during sterilization extend the sealing cycle of the package sealing device or weld a double seam Non observance can ultimately lead to unsterile instruments an...

Page 22: ...ion containers 15G max 3 sterilization containers 17K max 3 swab drums 17R max 2 swab drums 23R max 2 sterilization containers 28M max 1 sterilization container 28G max 3 standard tray cassettes Maximum total weight 7 kg 2 5 kg 5 kg 2 kg Mountings trays sterilization containers norm tray cassettes from MELAG see Appendix A Accessories Close the door When closing the door of the autoclave observe t...

Page 23: ...e cooling water temperature and supply voltage Select automatic pre heating With the automatic pre heating the chamber of the autoclave before a program start is kept to the program specific pre heating temperature or maintained at this temperature between two program runs Prerequisite is that the autoclave remains continuously switched on The condensate formation at the chamber wall is reduced an...

Page 24: ...he end of sterilization or the expired drying time is displayed Evacuation phase Program Start Stop In the Evacuation Phase fractionation air is evacuated repeatedly until a program dependent pressure is reached This occurs in alternation with the inflow of steam up to a slight overpressure Depending on selected program and the current chamber temperature at program start additional fractionations...

Page 25: ...e confirmation prompt is shown for about 5 seconds on the display If the key is not pressed again the program continues with the normal process Depending on the point in time of the termination a pressure discharge or ventilation of the instrument is carried out An appropriate display is shown on the screen After the pressure discharge or ventilation is carried out there is a request for an acknow...

Page 26: ...y the operator or aborted by the system in the event of an error Program abort by the system At a system abort the system puts the chamber into a pressureless state NOTICE If the program is terminated by the operator a warning text appears If the program is aborted by the system an error message is displayed Drying phase The autoclave does an excellent job of drying the items to be sterilized In t...

Page 27: ...instruments This endangers the health of the patient and the practice team Open door After the end of the program the information Please wait door unlocking is displayed After unlocking the door and the display Please open door appears you can open the door and remove the sterilized items For connected printer and Immediate printout Yes a logging printout is additionally carried out see page 32 Au...

Page 28: ...ion in accordance with the type of package wrapping Storage time The maximum storage life depends on the packaging and the storage conditions For sterilized items which have been wrapped in compliance with the standards dust protected storage is assumed this time period is up to six months ...

Page 29: ...rogram or subsequently e g at the end of a work day in the practice Capacity of the internal log memory The capacity of the internal storage suffices for about 40 logs If the internal log memory is full when starting the next program the respectively oldest report is automatically overwritten If you have connected a printer and additionally the option immediate printout is set to no see also Page ...

Page 30: ...analogously After finishing the settings press the KEY S in to leave the menu On the display the Function Date Time are again displayed By pressing the key S again you leave the menu completely and the display again shows its starting position Use printer as output medium If you want to employ the printer MELAprint 42 as the output medium connect it to the autoclave as follows Data connection from...

Page 31: ...ack to the menu Print File transmission Press the KEY S in order to return to the menu Function Print After renewed pressing of the KEY S the display again shows the initial state Test printouts on the log printer MELAprint 42 In order to verify the functional reliability of the log printer MELAprint 42 and its communication with the autoclave a test printout can be carried out Select the SETUP Me...

Page 32: ...ELAwin must be installed for the log readout In order to register the computer at the autoclave proceed as described on page 31 Initialisation of the Log Printer Observe that for the menu File Transmission you must make the setting External PC instead of external printer Automatic immediate log output If you immediately would like to output the associated report automatically on an output medium a...

Page 33: ...nt Press the KEY P The Menu Print File transmission is displayed Navigate with the KEY or until the display last cycle Print No 40 is shown as example No 40 Press the KEY P The current report number blinks In order to print a log of another cycle navigate with the KEYS or up to the desired number here e g 25 Press the KEY P in order to start the printout of the selected program The display shows P...

Page 34: ... keys and The display shows Function Print Press the KEY P The Menu Print File transmission is displayed Navigate with the KEY or until the display shows Delete all cycles Press the KEY P in order to delete all logs now In order to cancel the submenu without deleting press the KEY S In order to leave the menu after deletion press the KEY P The display shows Function Print By again pressing the KEY...

Page 35: ...and the autoclave type Values of the program steps During the program the program sequence phases are recorded with the accompanying values for steam pressure temperature and time relative to the program start Summary The summary states whether the program was successfully concluded Furthermore the values of the required sterilization time the sterilization temperature and the pressure including i...

Page 36: ...0 Sterile end 2 18 136 0 20 40 Pressure release 0 18 105 3 21 31 Vacuum drying Drying begin 0 31 91 8 21 44 Drying pressure 0 92 69 2 26 14 Drying pressure 0 92 75 7 31 14 Drying pressure 0 93 71 1 36 14 Drying end 0 55 72 7 36 44 Ventilate 0 29 73 3 36 51 End 0 00 74 2 37 01 Values of the program steps Program sequence phases with the accompanying values for pressure temperature and time relative...

Page 37: ...ith cleaning alcohol or methylated alcohol and try to wipe off the contamination In case of persistent soiling of the chamber mounting or chamber sealing surface employ only a mild stainless steel cleaning agent with a pH value between 5 and 8 Employ neutral liquid cleaning agents to clean the door seal No cleaning agents may get into the piping system which exits the autoclave chamber Do not use ...

Page 38: ...the other instruments or in the autoclave Remove third party rust from the instruments with a chlorine free stainless steel cleaning agent see page 37 Cleaning or send the damaged instruments to the manufacturer for reconditioning Formation of spots due to inadequate quality of the feed water The extent of the formation of spots on the instruments also depends on the quality of the feed water empl...

Page 39: ...Have maintenance carried out only by trained field service technicians or technicians of the specialist trade Turn to your specialist dealers or MELAG customer service in your vicinity Comply with the predetermined maintenance intervals Malfunctions at the autoclave can occur on continuation of operation despite the servicing message For retention of value and functional reliability Regular mainte...

Page 40: ...from premature wear Furthermore it prevents the sticking of the door seal Close the cooling water inlet and if available the water feed of the water treatment unit After operating pauses which last longer than two weeks carry out a vacuum test and thereafter an empty sterilization with the Quick Program see page 42 Chapter 8 Function test The following situations can occur after longer pauses Even...

Page 41: ...nd the footprint is small In case of non observance spine damage and contusions can result Warning Observe the following when transporting the autoclave e g when moving or shipping the autoclave or for the transport within the practice When using a water treatment unit close the water feed and removal the hose connections at the rear of the device If you would like to leave the mounting and the tr...

Page 42: ...r control The process evaluation system of the autoclave compares the process parameters with each other during the program and monitors them with respect to their limit values The monitoring system of the autoclave checks the device components with regard to their functional reliability and their plausible interaction If the parameters exceed defined limit values the autoclave outputs warning mes...

Page 43: ...ten minutes follow The rise in pressure in the chamber is measured within the measurement time The evacuation pressure and the equilibration time or measurement time are shown on the display After the expiration of the measurement time the chamber is ventilated appropriate display message Subsequently the message with specification of the leakage rate is shown on the display If the leakage rate is...

Page 44: ...The proper use of the Helix test body as directed can nevertheless result in a discoloration of the plastic surface However this discoloration has no influence on the functional capability of the Helix test body Display water quality You can at all times have the display of water quality shown on the switched on the autoclave also during a running program To do this keep the KEY pressed until the ...

Page 45: ...rror messages are displayed if safe operation or sterilization security is not guaranteed These can appear on the display shortly after switching on the autoclave or while a program is running The program is aborted if a malfunction occurs during a program run Danger of infection If a program is aborted during the sterilization phase the load is unsterile Repackage and repeat the sterilization for...

Page 46: ...eck cooling water inlet open faucet Check cooling water pressure install increase in pressure e g house waterworks Press the reset button of the motor circuit breaker Fig 1 Reset button of overheating protection again Turn vacuum pump see Technical Manual Warning No feed water check aqua dem dest quality Too little or no water in the storage tank Intake hose bent Suction level too high max suction...

Page 47: ...r treatment unit Exchange module resin cartridge according to the operating manual of the manufacturer On repeated occurrence carry out maintenance NOTICE Initiate program start after completion of the above mentioned work On the first start after changing the water in the external storage tank or after maintenance on the water treatment this warning text can appear once again since the inlet hose...

Page 48: ...se the printer in the menu File transmission and set the option No printer Execute Service The servicing message is activated the device has reached the prescribed batches or number of years has expired The message is shown at program start Repeatedly press the KEY S to delete the message and the program starts Carry out maintenance with MELAG customer service or service of the specialist trade NO...

Page 49: ...ccurrence notify specialist dealers Error 9 Door open The sliding closure grip was pushed upwards during a running program Push the sliding closure grip downwards until the stop Correct display Door closed On repeated occurrence notify your specialist dealer Error 10 Overheat Steam generator Capillary tube regulator level control is opened at program start error message immediately after start or ...

Page 50: ...alers Error 32 Power loss Sterilize sterile filter The loss of the operating voltage occurred after the start of a program The error message occurs after the operating voltage is again available Check building side installation If no defects are detectable notify customer service In the event of power failure after a program has been started in overpressure an additionally request appears to steri...

Page 51: ...ted occurrence notify your specialist dealer No display on the screen After switching on the autoclave the display remains empty What you can do Check whether the power plug is correctly in the socket Check the supply voltage at the socket If necessary switch the instrument securing at the lower front of the autoclave see page10 Fig 1 8 off Follow the instructions in the technical manual in Exchan...

Page 52: ...f the unit The floor of the vessel must be free Where applicable remove fallen instruments filter paper etc The tank filter is clogged If necessary check and clean it Pay attention to the correct loading of the autoclave see page 20 Load the autoclave Do not overload the autoclave Pay attention that textiles have no direct contact with the chamber wall and floor Activate the pre heating see page 2...

Page 53: ...ith unwanted or harmful materials Corrosion Chemical change or destruction of metallic materials by water and chemicals Delayed boiling This is the phenomenon that in certain conditions liquids can be heated beyond their boiling point without boiling this state is unstable a slight shock can cause a very rapid formation of a large gas bubble which expands like an explosion Demineralized water Also...

Page 54: ...mum mass for their sterilization in a sterilizer designed according to DIN EN 13060 DIN EN 13060 Porous partial load Check of porous partial load Serves to verify that for the values set on the control the steam quickly and uniformly penetrates into the defined test packet DIN EN 13060 Porous small parts Made of materials which can absorb fluids e g liquids Process evaluation system Also self moni...

Page 55: ...ads to a vaporizing of the water VDE Verband der Elektrotechnik Elektronik und Informationstechnik e V Association of German Electricians VDE 0510 Standard of the VDE Provisions for accumulators and battery units Water ring pump Pump which creates the vacuum for the sterilization cooled with water ...

Page 56: ... cm 42 16 12 01232 28M depth width height in mm 32 16 6 01284 28G depth width height in mm 32 16 12 01285 17R diameter height in cm 13 10 5 00174 Swab drums with filter cloth 23R diameter height in mm 18 14 00233 Package Holder for chamber 25 cm X 45 or 35 cm 22420 22410 Standard tray cassette Perforated depth width height in mm 29 19 4 with filter cloth 00289 without filter cloth 00286 Trays tray...

Page 57: ...e declares that he satisfies all requirements of the law concerning the release withdrawal and environmentally compatible disposal of electric and electronic appliances With the CE sign CE 0124 the manufacturer declares that the medical device corresponds to the basic requirements of the German Medical Device Guideline The four digit number means that an approved certification body here DEKRA moni...

Reviews:

No comments