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User Manual

 

 

Autoclave 

 

Cliniklav

25

 

as of software version 5.15 

 

 

Dear Dr. 
 
We should like to extend our thanks for the expression of trust in our company which you have displayed 

through the purchase of this MELAG product. 

As an owner-run and operated family concern founded in 1951, we have a long history of successful 

specialization in hygiene products for practice-based use. Our focus on innovation, quality and the 

highest standards of operational reliability has established MELAG as the world’s leading 

manufacturer in the instrument treatment and hygiene field.  

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

"competence in hygiene"

 

and 

"Quality – made in Germany"

, we guarantee that these demands 

will be met. Our certified quality management systems is subject to close monitoring: one instrument 

to this end is our annual multi-day audit conducted in accordance with ISO 13485 and ISO 9001. 

This guarantees that all MELAG products are manufactured and tested in accordance with strict 

quality criteria. 

 

The MELAG management and team. 

 

 

 

 

 

 

Summary of Contents for Cliniklav 25

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

Page 2: ...iklav 25 Responsible for the contents MELAG Medizintechnik oHG Geneststra e 6 10 10829 Berlin Germany E Mail info melag com www melag com Document BA_2_GB_25C_v6 doc Revision 6 16 1560 Alteration date...

Page 3: ...1 Power supply 10 3 2 Connection of a water treatment unit 10 3 3 Vacuum test 10 3 4 Bowie Dick test 12 3 5 Trial run 12 3 6 Record of installation and setting up 13 3 7 Validation 13 4 STERILIZATION...

Page 4: ...6 8 2 Helix test body system MELAcontrol PRO 36 8 3 Continuous monitoring of sterilization process 36 9 OPERATIONAL ERRORS MALFUNCTIONS 37 9 1 Warning messages 37 9 2 Malfunction messages 39 9 3 React...

Page 5: ...urns The autoclave is intended for use outside the patient environment The minimum distance to the treatment area must have a radius at least 1 5 meters Under current VDE regulations this autoclave is...

Page 6: ...hat must not be disposed in domestic waste The vendor is responsible for appropriate disposal of the device it must be delivered to the vendor to be disposed of By the designation of an apparatus with...

Page 7: ...1 15 14 Fig 1 Views of the Cliniklav 25 1 Control panel 9 Emergency pressure release and cavitation outlet 2 Door opens to the left 10 Sterile filter 3 Door opener 11 Feed water inlet 4 Emergency door...

Page 8: ...tting Program selection for sterilization programs test programs and for selecting options sub menus of the special functions Start Stop key to start and interrupt programs drying and to control speci...

Page 9: ...the next program run An integrated conductivity measurement system monitors the quality of the distilled or demineralized water used for the steam generation For frequent operations the larger demand...

Page 10: ...o optimally meet the needs of the Cliniklav 25 with respect to water quality and output The user manual for the MELAdem 55 contains detailed instructions for installation and operation of this water t...

Page 11: ...tion with Quit with key By pressing the key the door is unlocked and the door can be opened after the message Open door please is displayed 8 The display shows the selected program If the leakage rate...

Page 12: ...e Bowie Dick test is not the more or less strong contrast of the colour change rather the even nature of the colour change on the test sheet If the treatment strips treatment indicator sheet indicates...

Page 13: ...ludes the formation of rust as a result of the components of the autoclave Where rust forms on the autoclave or the items to be sterilized investigations have repeatedly shown that this rust has been...

Page 14: ...sed sterilization containers Closed sterilization containers must be perforated on at least one side preferably underneath or must have valves in order to ensure that steam can penetrate and condensat...

Page 15: ...on time of 3 5 min Sterilization only of unwrapped instruments no textiles for rapid re use drying can be interrupted manually Gentle Program at 121 C 1 bar and a sterilization time of 20 5 min Steril...

Page 16: ...50 Operation Display message At the start of the program press the key The display shows a message confirming the extra drying and then the program runs as described in section 4 9 but with 50 longer...

Page 17: ...ired pressure and temperature have been reached the sterilization proper then begins The display shows alternately the pressure and temperature and the time remaining 5 Pressure release After completi...

Page 18: ...t When using Quick Program S you can perform an early drying abort effecting immediate renewed availability The unwrapped instruments are to be removed following program end and left to dry through th...

Page 19: ...he Universal Program and Gentle Program With the Quick Program S it may be desirable to interrupt the drying program so that items can be used again The unwrapped items will dry as they are cooling do...

Page 20: ...repeated after the items have been re wrapped It is important for sterile storage that the items have been properly dried The Cliniklav 25 provides very good drying if the program has not been interr...

Page 21: ...in to return to the starting point 4 14 Display total batch number ____________________________________________ The Cliniklav 25 keeps a running count of the total number of batches sterilized and thi...

Page 22: ...printer or another output medium is connected and operable and the option Immed output NO has been selected then confirmation will be requested before the oldest log is overwritten see Section 9 1 Yo...

Page 23: ...t are necessary return to point 4 and begin again 8 or press Start Stop to return to the Function menu and 9 press Start Stop again to return to the starting point Program Start Stop Date Time Year 19...

Page 24: ...low voltage output of the power supply unit into the power supply jack on the rear of the printer For operation of the printer please consult the instructions in its user manual 5 2 2 Initialising the...

Page 25: ...own key and also press Select Function menu submenu Print 2 Navigate with key or to the submenu Batch output 3 Press Program key the display shows the menu Batch output submenu output medium 4 Press o...

Page 26: ...step 6 select MELAflash or MELAnet as output medium 5 6 No output medium __________________________________________________ In order to select the option No output medium proceed as described as in se...

Page 27: ...tput a log subsequently and independently from the time of the end of a program an output medium is connected and initialised proceed as follows Operation Display message 1 Hold down key and also pres...

Page 28: ...d return to the Function menu 10 Press the Start Stop key to return to the initial display 5 7 3 Display protocol memory With a connected and initialised printer or another output medium the status of...

Page 29: ...ed printer or another output medium then select the following options after switching on the autoclave Operation Display message 1 Hold down key and also press key Select Function menu submenu Print N...

Page 30: ...rder to delete all stored logs e g in the event of the warning message Protocol memory full with the option Immed output NO selected see section 5 7 1 then after switching on the autoclave proceed as...

Page 31: ...ey to delete all stored logs or press Start Stop to terminate 5 Then press Start Stop to return to Function menu 6 and press Start Stop again to return to the starting display Program Start Stop Funct...

Page 32: ...06 36 2 Fractionation Evacuation 0 84 58 1 09 54 Steam entry 0 41 109 8 14 05 3 Fractionation Evacuation 0 84 57 9 17 47 Steam entry 0 40 109 8 21 48 4 Fractionation Evacuation 0 84 65 9 25 22 Steam e...

Page 33: ...e and the door hinge left side must be regularly lubricated with silicone grease in order to ensure that the door can easily be locked and unlocked without unnecessary wear The outer parts of the auto...

Page 34: ...ained the non rusting materials used in the autoclave cannot cause rust formation in the autoclave Where rust forms this is drag in rust This originates from instruments or other metal items carrying...

Page 35: ...7 6 Renewed Qualification________________________________________________ DIN EN 17665 recommends a new qualification at regular intervals A new standard DIN 58946 7 is currently in preparation This w...

Page 36: ...st body system MELAcontrol MELAcontrol PRO is an indicator and batch control system fulfilling the requirements of DIN EN 867 5 It consists of a test body the Helix and an indicator strip If sterilizi...

Page 37: ...sure if too low it may be necessary to install a pressure booster Check if the motor protection switch has tripped Fig 2 pos 17 no sound from vacuum pump Press button of protection switch back down Fl...

Page 38: ...t body e g MELAcontrol PRO should be added to each sterilization cycle Conductivity of the demineralized or distilled water exceeds the second limit value of 35 S cm a program start is no longer possi...

Page 39: ...ssages occur during operation you can continue to use the autoclave until the regular service when the cause of the leak will be identified 9 2 Malfunction messages____________________________________...

Page 40: ...filter is clogged there will have been an earlier warning message see section 9 1 Exchange filter Maximum difference between the program duration and the internal clock exceeded If this occurs repeat...

Page 41: ...is may have become moist and non sterile Remove the sterile filter at the rear of the autoclave Sterilize the filter using the Quick Program S Then replace the filter The time limit for the steam gene...

Page 42: ...e temperature measured at temperature sensor 2 is too large If this occurs repeatedly inform your specialist dealer or After sales Service Also see malfunction 38 9 3 Reaction to warnings error messag...

Page 43: ...hen the autoclave is switched on or if the display blacks out repeatedly please inform your specialist dealer If you exchange the fuses order two new spare fuses through your dealer MELAG Art No 57590...

Page 44: ...are no kinks in the drain hose 2 Check that the condensate outflow is not blocked by dropped instruments filter paper etc on the floor of the pressure chamber 3 Check that the maximum load has not bee...

Page 45: ...hamber and seal for its correct condition see section 7 1 Check of the operating materials see section 4 1 Check of the operation readiness of the recording equipment see section 5 3 Feed water qualit...

Page 46: ...dB A Heat emission ca 4 MJ Max altitute 2000 m Ambient temperature 5 40 C recommended max 25 C Relative humidity 80 at 31 C decreasing in a linear fashion up to a relative humidity of 50 at 40 C CE m...

Page 47: ...load Quick Program S approx 1 57 2 1 kWh 1 kg 15 kg load unwrapped Gentle Program approx 2 8 3 6 kWh 1 kg 7 kg load Prion Program approx 2 8 4 0 kWh 1 kg 15 kg load Bowie Dick Test approx 3 0 kWh redu...

Page 48: ...in 12 min Quick Program S 2 1 2 2 bar 134 136 C 5 30 min 10 min Prion Program 1 1 1 2 bar 121 122 C 20 30 min 20 min Variable cycle times with max load of 15 kg instruments with complete drying Progra...

Page 49: ...ying standards for sterilized items Particularly difficult drying tasks e g double wrapping can also be dried to very good standards with the help of the supplementary drying function and the automati...

Page 50: ...Heat Heat Heat Heat Fig 10 Drying For good drying it is essential that surplus heat be transfered to the objects which have been sterilized In addition the condensate must be led out of the steriliza...

Page 51: ...s such as instrument oil should be avoided unless absolutely necessary Prior confirmation should be obtained from the manufacturer of such agents that they are in fact suitable for steam sterilization...

Page 52: ...sterilization containers of the same size so that condensate can flow down the sides Fig 14 Stacked sterilization containers 11 4 7 Removing the sterilized items _____________________________________...

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