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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.
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Summary of Contents for MELAG Cliniklav 25
- Page 1 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.
- Page 2 ® User Manual Cliniklav ® Valid for Cliniklav Responsible for the contents: MELAG Medizintechnik oHG Geneststraße 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: 12-07-2016 Subjects to technical changes...
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Page 3: Table Of Contents
User Manual for the Cliniklav To ensure the functional effectiveness of this unit and to preserve its value: 1. Prepare the instruments to be sterilized carefully 2. Take proper care of the autoclave 3. Use only pure distilled or demineralized water CONTENTS SAFETY INSTRUCTIONS ......................... - Page 4 Computer as output medium ......................26 Employing other devices as output medium ..................26 No output medium ..........................26 Output of the logs ..........................26 5.7.1 Automatic immediate log output....................26 5.7.2 Output selected logs subsequently .................... 27 5.7.3 Display protocol memory ......................28 5.7.4 Output all stored logs .........................
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Page 5: Safety Instructions
• Before opening the housing always disconnect from the mains power supply! • If you intend to install a water treatment unit from another manufacturer, then consult MELAG before you do so. • We recommend the installation of a water leak detector. -
Page 6: Symbols On The Autoclave
MELAG devices are synonymous for long-term quality. When you eventually need to decommission your MELAG device, we offer a special disposal service. Simply contact your stockist. In affixing the CE mark, the manufacturer declares that this medical product fulfils the basic requirements of the medical products directive. -
Page 7: Description Of The Unit
User Manual for the Cliniklav Description of the unit Views of the unit _____________________________________________________ 61,6 cm Front view Rear view 49,4 cm 6,1 cm 80,7 cm 3,3 cm Side view 53,2 cm 17,3 cm 10,3 cm Fig. 1: Views of the Cliniklav Control panel Emergency pressure release and cavitation outlet Door, opens to the left... -
Page 8: Control Panel
User Manual for the Cliniklav Fuse 3x20 A Protective motor switch Reset for steam generator Door contact switch Front view (without door) ® Fig. 1: Front view Cliniklav Fig. 2: Front view of the Cliniklav Control panel _______________________________________________________ 2 x 20- alphanumeric LED-display, showing program status, and parameters for basic and special functions... -
Page 9: Performance Features Of This Autoclave
User Manual for the Cliniklav Performance features of this autoclave __________________________________ 2.3.1 Fractionating pulsed vacuum procedure ______________________________________________ A fractionating pulsed vacuum method involved the repeated evacuation of the sterilization chamber, alternating with the introduction of steam in order to ensure the necessary penetration of the items undergoing sterilization with superheated steam. -
Page 10: Installation And Initial Start-Up
We always recommend that you first coordinate with the MELAG company before buying another water treatment unit. - Page 11 User Manual for the Cliniklav After waiting for the Program Start-Stop equilibration (5 min) the V a c u u m t e s t 0 7 : 5 2 measuring period starts P r e s s u r e 8 2 m b a r (running here e.g.
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Page 12: Bowie & Dick Test
If the treatment indicator strips or the treatment indicator sheets are uncoloured or exhibit less colour in the centre of the star in comparison to the end, ventilation was insufficient. In such a case, please consult the stockist customer services/MELAG customer services. Trial run ____________________________________________________________ In order to check the operation of the autoclave under realistic conditions, a test run should be carried out with the "Universal-Program, 134°C wrapped"... -
Page 13: Record Of Installation And Setting Up
As documentation that the autoclave has been set-up properly, a record of installation and setting up should be produced by an authorised person and a copy sent to MELAG. This is important in the event that you wish to make claims under warranty provisions. -
Page 14: Loading The Autoclave
If you use transparent sterilization packaging, such as MELAfol , then the items should if possible be stood vertically on the tray, or sterilized in foil holders (MELAG Art. no. 22420). They should never be laid flat one on top of the other. -
Page 15: Program Selection
User Manual for the Cliniklav Suitability for sterilization Relevant information provided by manufacturers of instruments and textiles about sterilization should be strictly observed. Program selection __________________________________________________ A program should be selected which is appropriate for the physical properties of the items being sterilized (and in particular their heat resistance) and the type of packaging (if any part of the load is wrapped, then either the "Universal-Program"... -
Page 16: Pre-Heating
User Manual for the Cliniklav Pre-heating _________________________________________________________ Operate the Cliniklav 25 only after it has been pre-heated. This will reduce the condensation of water on the wall of the sterilization chamber: which shortens the cycle times and greatly improves drying. When you start the Quick-Program S with an empty sterilization chamber, the cold autoclave chamber will be pre-heated. -
Page 17: Program Progress
User Manual for the Cliniklav Program progress ___________________________________________________ After starting the program, it will then progress automatically. The display shows the current program status as follows: Program status Display message 1. 1. Fractionation consisting of evacuation Start-Stop Program (removal of air) until the appropriate 1 . -
Page 18: Manual Termination Of Program
User Manual for the Cliniklav 8. Program end Program Start-Stop After ventilation of the chamber the U n i v e r s a l - P r o g r a m program is completed. If a printer or another output medium is r u n s u c c e s s f u l l y attached and option "Immediate output"... -
Page 19: Terminate During Drying
User Manual for the Cliniklav 3. After pressure equilibration, the display Start-Stop Program will alternately show the messages S t o p / E n d "Program stopped" and an offer to quit the program termination. 0 . 0 2 b a r 8 8 °... -
Page 20: Removing The Sterilized Items
User Manual for the Cliniklav 4. This is followed by ventilation of the Start-Stop Program autoclave chamber. V e n t i l a t i o n - 0 . 5 2 b a r 1 1 2 ° C After the ventilation of the chamber the Program Start-Stop... -
Page 21: Display Batch Number
User Manual for the Cliniklav 4.13 Display batch number ________________________________________________ After every completed program you automatically see on the display the last batch number of the day. You can also allow the display of the last batch number whenever necessary: Operation Display message 1. -
Page 22: Logging
User Manual for the Cliniklav Operation Display message 4. Close by pressing Program Start-Stop "Start-Stop", and return F u n c t i o n : to the "Function" menu, then T o t a l b a t c h 5. - Page 23 User Manual for the Cliniklav Operation Display message 4. By pressing the "+" (or Program Start-Stop "-") key the following D a t e / T i m e options can be selected: M i n u t e : 2 3 Program Start-Stop D a t e / T i m e...
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Page 24: Log Printer Melaprint ® 42 As Output Medium
User Manual for the Cliniklav ® Log printer MELAprint 42 as output medium _____________________________ If you have purchased a Cliniklav 25 with pre-installed log printer, and if you still cannot print out, then please continue below with Section 5.2.2. ®... -
Page 25: Test Output
User Manual for the Cliniklav 7. Press "Program" key, Program Start-Stop confirm the setting, B a t c h o u t p u t return to "Batch output" menu. O u t p u t m e d i u m 8. -
Page 26: Computer As Output Medium
User Manual for the Cliniklav Operation Display message 6. Then press "Start-Stop" Program Start-Stop to return to the F u n c t i o n : "Function" menu … B a t c h o u t p u t 7. -
Page 27: Output Selected Logs Subsequently
User Manual for the Cliniklav Operation Display message 4. Navigate with key '+' ( or ''-') to the submenu Program Start-Stop B a t c h o u t p u t "Immed. output". I m m e d . o u t p u t 5. -
Page 28: Display Protocol Memory
User Manual for the Cliniklav Operation Display message Press "+" (or "-" ) until Program Start-Stop the submenu "Output L a s t c y c l e last cycle" appears on the display. o u t p u t : N o . -
Page 29: Output All Stored Logs
User Manual for the Cliniklav Operation Display message Navigate with key '+' ( or ''-') to the submenu Program Start-Stop F u n c t i o n : "Batch output". B a t c h o u t p u t 2. -
Page 30: Delete All Stored Logs
User Manual for the Cliniklav Operation Display message 3. Press "+" (or "-") until Program Start-Stop the submenu "Output O u t p u t stored cycles" appears on the display. s t o r e d c y c l e s 4. - Page 31 User Manual for the Cliniklav Operation Display message 3. Press "+" (or "-" ) until Program Start-Stop the display shows A l l c y c l e s "Delete all cycles". d e l e t e 4. Press the "Program" Start-Stop Program key to delete all stored...
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Page 32: Read Log Files Correctly
User Manual for the Cliniklav Read log files correctly ______________________________________________ The log file contains the following information: --------------------------------------- MELAG Cliniklav 25 --------------------------------------- Program Program : Universal-Program Date 134°C wrapped Date : 30.01.2008 Time : 08:35:50 (Start) Time of start Batch No. -
Page 33: Sterilization Frequency
If the feed water is not provided directly but is stored in a container then this should be inspected every time it is refilled to make sure it is clean. If necessary it should be cleaned before refilling. If you have a MELAG storage container then please note the instruction on the label. -
Page 34: Rust Formation = Drag-In Rust
User Manual for the Cliniklav It is advisable to make use of appropriate cleaning aids such as ultrasonic cleaning units, cleaning and maintenance equipment for hand pieces and contra-angles, or thermo-disinfecting systems. Cleaning the instruments before sterilization is very important in order to avoid introducing contamination which can separate from the instruments under steam pressure during sterilization and block filters, jets and valves of the autoclave. -
Page 35: Avoid Formation Of Spots
As well as all essential components and electrical elements, parts are also inspected for wear and replaced as necessary. A maintenance reminder appears on the display every two years or after 1000 sterilizations. Consult your dealer of the MELAG Customer service if you have any questions relating to servicing and maintenance. Notice National pressure vessel requirements may ask the user of pressure vessel, such as autoclaves, to carry out safety inspections. -
Page 36: Function Test
User Manual for the Cliniklav Function test Water quality (conductivity) ___________________________________________ The conductivity should be checked every day before starting routine operation. NOTE If the autoclave is continued operating even if the warning message is issued as soon as the conductivity value has reached 20 µS/cm a Helix test body should be added to each sterilization cycle to check the steam for non-condensable gases (see next section). -
Page 37: Operational Errors/Malfunctions
Following these instructions continue to work with the autoclave. If the malfunction occurs repeatedly then contact your dealer, and authorised MELAG customer service or contact MELAG directly. You should describe the problem precisely and include the works number of your autoclave. - Page 38 • The sterile filter may be clogged or torn. Exchange the sterile filter (MELAG Art. No. 20160). S t e r i l e f i l t e r...
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Page 39: Malfunction Messages
• You can continue operations, by simply pressing the "Start/Stop" key twice when you start a program. • Have a service carried out as recommended by an authorised MELAG servicing company or your specialist dealer. The cycle counter for servicing should be reset during the service. - Page 40 User Manual for the Cliniklav Error messages Causes/Remedy The monitoring time for reaching the evacuation pressure M a l f u n c t i o n 1 : for the individual pressure cycles, pressure release, or for V a c u u m s y s t e m reaching the minimum drying pressure has been exceeded: •...
- Page 41 User Manual for the Cliniklav The internal testing of the sensors for temperature, M a l f u n c t i o n 1 8 : pressure or conductivity showed an excessive deviation, S e n s o r : . . . I n p u t : . . . the malfunction can be reported on switching on the autoclave or in the course of a program: •...
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Page 42: Reaction To Warnings/Error Messages
User Manual for the Cliniklav Defective cooling fan, defective temperature sensor (Input W A R N I N G ! 4), air supply to the cooling fan at the back plane is covered or hindered e.g. by extreme soiling or dust O v e r t e m p . -
Page 43: No Display On The Screen
If you exchange the fuses, order two new spare fuses through your dealer (MELAG Art.-No. 57590). Emergency measure if the electric door release button fails _________________... -
Page 44: Too Large Feed Water Consumption
There is the standard option "Additional drying". Any further program modification to suit specific individual requirements should only be carried out by authorised personnel, after consultation with your dealer or with the experts at MELAG. -
Page 45: Important Information Regarding Routine Operation
User Manual for the Cliniklav Important information regarding routine operation The former DIN 58946-6 and future DIN 58946-7 both prescribe the following fundamental procedures for routine operation the autoclave: Time of test Nature of test Before starting routine operation Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) -
Page 46: Appendix
User Manual for the Cliniklav Appendix 11.1 Technical Data ® Device type Cliniklav Table-top device with floor unit Device dimensions (HxWxD) 80 x 62 x 80 (84) cm 150 x 62 x 80 (84) cm Sterilization chamber 32 x32 x 65 cm (HxWxD) Effective capacity 30 x 30 x 60 cm... -
Page 47: Additional Technical Data
User Manual for the Cliniklav 11.2 Additional technical data ______________________________________________ Dimensions: Depth Width Height The unit holds: Tray 60 cm 30 cm 5 cm 4 each Standard-tray cassette 29 cm 19 cm 4 cm 18 each Sterilizing container 1 STE 1 each Sterilizing container 1/2 STE 2 each... - Page 48 User Manual for the Cliniklav Average feed-water consumption (normal setting with steam generator cleaning): Program Feed water consumption Conditions Universal program approx. 4.4 ... 5.8 l 1 kg ... 15 kg load Quick-Program B approx. 4.0 … 5.5 l 1 kg …...
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Page 49: Nominal Value Tolerances
User Manual for the Cliniklav 11.3 Nominal value tolerances ____________________________________________ Universal-Pr. Quick B Prion-Pr. Gentle-Pr. Quick S ◄ same meaning as in Universal-Pr. Step Press. P Tolerance Tol. Tol. Tol. Tol. All values in mbar evacuate + 50/- 20 ◄... -
Page 50: Textiles
User Manual for the Cliniklav Steam Heat Condensate Heat Fig. 9: Formation of condensation on sterilized objects After sterilization, during the drying phase, all the condensation must evaporate from the sterilization container and from the sterilized items themselves. This is achieved by the transfer to the condensate of heat stored in the walls of the sterilization container and in the sterilized items themselves. -
Page 51: Instruments
User Manual for the Cliniklav Fig. 11: Loading textiles properly When loading sterilization containers with textile items, care should be taken to ensure that they retain their vertical orientation, but that the items are not squashed together. This would prevent the formation of flow channels for air and steam. -
Page 52: Loading Containers With Soft Sterilization Packing Material
The drying can be improved by the following measures: • Pre-heating the autoclave (empty sterilization) • Arranging transparent sterilization and paper packing vertically • Selecting the program option "Additional drying" Extending the drying times (please consult your MELAG customer service).
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