MELAG Cliniklav 25 User manual

User Manual
Autoclave
Cliniklav
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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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User Manual Cliniklav®25
Valid for Cliniklav®25
Responsible for the contents:
MELAG Medizintechnik oHG
Geneststraße 6-10
10829 Berlin
Germany
E-Mail: [e-mail]
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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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
1SAFETY INSTRUCTIONS ......................................................................................................................... 5
1.1 Symbols on the autoclave ................................................................................................................... 6
2DESCRIPTION OF THE UNIT ................................................................................................................... 7
2.1 Views of the unit .................................................................................................................................. 7
2.2 Control panel ....................................................................................................................................... 8
2.3 Performance features of this autoclave .............................................................................................. 9
2.3.1 Fractionating pulsed vacuum procedure...................................................................................... 9
2.3.2 Programs for sterilization ............................................................................................................. 9
2.3.3 Separate steam generation.......................................................................................................... 9
2.3.4 One-way system/Conductivity measurement/Automatic water supply........................................ 9
2.3.5 Electronic Parameter Control (EPS) ............................................................................................ 9
2.3.6 Vacuum drying ............................................................................................................................. 9
2.3.7 Documentation ............................................................................................................................. 9
3INSTALLATION AND INITIAL START-UP ............................................................................................. 10
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
4STERILIZATION ...................................................................................................................................... 13
4.1 Supply with fresh purified feed water/cooling water.......................................................................... 13
4.2 Preparation of instruments ................................................................................................................ 13
4.3 Loading the autoclave ....................................................................................................................... 14
4.4 Program selection ............................................................................................................................. 15
4.5 Pre-heating........................................................................................................................................ 16
4.6 Selecting extra drying........................................................................................................................ 16
4.7 Opening and closing the autoclave door........................................................................................... 16
4.8 Program start..................................................................................................................................... 16
4.9 Program progress.............................................................................................................................. 17
4.10 Manual termination of program...................................................................................................... 18
4.10.1 Terminate before beginning of drying ........................................................................................ 18
4.10.2 Terminate during drying ............................................................................................................. 19
4.11 Removing the sterilized items........................................................................................................ 20
4.12 Sterile storage................................................................................................................................ 20
4.13 Display batch number.................................................................................................................... 21
4.14 Display total batch number ............................................................................................................ 21
5LOGGING................................................................................................................................................. 22
5.1 Setting date and time ........................................................................................................................ 22
5.2 Log printer MELAprint®42 as output medium.................................................................................... 24
5.2.1 Connecting the log printer MELAprint®42 .................................................................................. 24
5.2.2 Initialising the log printer MELAprint®42..................................................................................... 24
5.3 Test output ........................................................................................................................................ 25

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5.4 Computer as output medium............................................................................................................. 26
5.5 Employing other devices as output medium ..................................................................................... 26
5.6 No output medium ............................................................................................................................. 26
5.7 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 ................................................................................................................. 29
5.7.5 Delete all stored logs ................................................................................................................. 30
5.8 Read log files correctly...................................................................................................................... 32
6OPERATING PAUSES ............................................................................................................................ 32
6.1 Sterilization frequency....................................................................................................................... 33
6.2 Shut-down/Transport......................................................................................................................... 33
7MAINTENANCE ....................................................................................................................................... 33
7.1 Cleaning ............................................................................................................................................ 33
7.2 Preparation of instruments ................................................................................................................ 33
7.3 Rust formation = Drag-in rust ............................................................................................................ 34
7.4 Use qualitatively high-grade feed water ............................................................................................ 34
7.5 Avoid formation of spots.................................................................................................................... 35
7.6 Renewed Qualification ...................................................................................................................... 35
7.7 Maintenance recommendations ........................................................................................................ 35
8FUNCTION TEST..................................................................................................................................... 36
8.1 Water quality (conductivity) ............................................................................................................... 36
8.2 Helix test body system MELAcontrol®/PRO ...................................................................................... 36
8.3 Continuous monitoring of sterilization process ................................................................................. 36
9OPERATIONAL ERRORS/MALFUNCTIONS......................................................................................... 37
9.1 Warning messages............................................................................................................................ 37
9.2 Malfunction messages ...................................................................................................................... 39
9.3 Reaction to warnings/error messages .............................................................................................. 42
9.4 No display on the screen................................................................................................................... 43
9.5 Emergency measure if the electric door release button fails ............................................................ 43
9.6 Too large feed water consumption.................................................................................................... 44
4. Bad drying results ................................................................................................................................. 44
9.7 Program modifications ...................................................................................................................... 44
10 IMPORTANT INFORMATION REGARDING ROUTINE OPERATION ............................................... 45
11 APPENDIX............................................................................................................................................ 46
11.1 Technical Data............................................................................................................................... 46
11.2 Additional technical data................................................................................................................ 47
11.3 Nominal value tolerances .............................................................................................................. 49
11.4 Instructions for drying .................................................................................................................... 49
11.4.1 Drying in sterilization containers ................................................................................................ 49
11.4.2 Textiles....................................................................................................................................... 50
11.4.3 Instruments ................................................................................................................................ 51
11.4.4 Loading the autoclave................................................................................................................ 51
11.4.5 Loading containers with soft sterilization packing material ........................................................ 52
11.4.6 Stacking sterilization containers................................................................................................. 52
11.4.7 Removing the sterilized items .................................................................................................... 52
11.4.8 Improving the drying .................................................................................................................. 52

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1 Safety instructions
•When opening the door, particularly after interrupting the drying process, residual steam can escape
from the autoclave chamber.
•After opening the door, do not touch any metal surfaces - these will be hot! Danger of burns. Always use
the tray lifter to remove trays, or wear suitable hand protectors when taking out other items.
•Do not sterilize any liquids with this autoclave. It is not licensed for the sterilization of fluids. Failure to
observe this can result in a delay in boiling, which could result in damage to the autoclave, burns and
other injuries e.g. through splintered glass.
•Do not sterilize any liquids with this autoclave. It is not approved for the sterilization of liquids. Failure to
observe, these instructions may lead to delayed boiling, damage to the autoclave and burns.
•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 not suited for use in areas where there are risks of
explosion.
•In order to ensure effective sterilization with the autoclave observe the instructions in this User Manual,
and in particular ensure that the loading of the autoclave is appropriate for the program selected.
•The autoclave must only be serviced and repaired by MELAG or by its authorised representatives
(specialist dealers or customer services) using only original parts and following service instructions.
•Documentation media (computer, CF card reader etc.) must be placed in such a way that they cannot
come into contact with liquids.
•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.

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1.1 Symbols on the autoclave _____________________________________________
Symbol
Explanation
Manufacturer of the medical device
Date of manufacture of the medical device
Serial number of the medical device by the manufacturer
Article number of the medical device
Indication of the scale of the chamber volume
Operating temperature of the device
Operating pressure of the device
This User Manual contains important safety information. Failure to comply of
the safety instructions could result in human and material damage.
Please read this user manual carefully before commissioning the device. The
manual includes important safety information. The functionality and value-
retention of this sterilizer depends on the care accorded to it. Please store this
user manual carefully and in close proximity to your sterilizer. It represents a
component of the product.
The symbol of the crossed out waste bin identifies a device that 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 this symbol, the manufacturer furthermore
declares that he satisfies all requirements of the law concerning the release,
redemption and environmentally sound disposal of electric and electronic
appliances. 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. The four-digit
number confirms that this is monitored by an approved certification agency.
In affixing this CE mark, the manufacturer declares that this medical product
fulfils the basic requirements of the pressure device directive. The four-digit
number confirms that this is monitored by an approved certification agency.
Indicates that operation of the autoclave should follow according to the safety
instructions in the User manual

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2 Description of the unit
2.1 Views of the unit_____________________________________________________
61,6 cm
74,8 cm
5 cm
6,1 cm
49,4 cm
80,7 cm
3,3 cm
53,2 cm
17,3 cm
10,3 cm
7
Front view
Rear view
Side view
8
9
16
10
13
11
12
6
5
4
3
2
1
15
14
Fig. 1: Views of the Cliniklav
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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 opening
12
Cooling water outlet (3/4" external thread)
5
Mains switch
13
Cooling water inlet (3/4" external thread)
6
Adjustable feet (when delivered without a
lower cabinet)
14
Safety valve
7
Fan
15
Serial Interface (RS 232)
8
Safety combination according to EN1717
16
Log-Printer

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Front view (without door)
17
19
18
20
Fig. 2: Front view of the Cliniklav
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17
Fuse 3x20 A
18
Protective motor switch
19
Reset for steam generator
20
Door contact switch
Fig. 1: Front view Cliniklav®25
2.2 Control panel _______________________________________________________
Start - Stop
Buttons for selecting, adjusting and
displaying special functions:
Printing, date/time, pre-heating,
total loads, conductivity, re-setting
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 special
functions
2 x 20-alphanumeric LED-display, showing
program status, and parameters for basic
and special functions
Program
Fig. 3: Control panel of the Cliniklav
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Technical Data
Chamber space (diameter x depth )
:
32 cm x 32 cm x 65 cm
Electric power supply
:
9000 W/400 V 3N AC/16 A/50/60 Hz
Sterilization pressure/temperature
:
2 bar/134°C; 1 bar/121°C
Maximum load
:
15 kg instruments or 7 kg textiles
For further technical data, please see the Appendix.

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2.3 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.
This means that even demanding sterilization tasks, involving for example intricate instruments or large
amounts of textiles can be completed quickly and reliably.
2.3.2 Programs for sterilization ___________________________________________________________
The Cliniklav®25 features three sterilization programs for temperatures at 134°C: the “Universal Program”
(for wrapped objects), the “Prion-Program” (a special Universal Program), the “Quick-Program” for
unwrapped items, and the “Gentle-Program” (a sterilization program for textiles and rubber articles at
121°C). The user can at any time perform additional functional checks of the autoclave by running the Bowie
& Dick test for steam penetration, and the Vacuum test for leak testing.
2.3.3 Separate steam generation __________________________________________________________
The generation of steam by a high-performance unit outside the sterilization chamber makes it possible to
sterilize large loads of instruments or textiles quickly. It is not necessary to have any pauses between the
sterilization runs, and overheating in the sterilization chamber is impossible.
2.3.4 One-way system/Conductivity measurement/Automatic water supply ______________________
The Cliniklav®25 operates with a reliable one-way system, in which all the condensate from a sterilization,
including any impurities which this may contain is completely eliminated and purified water used for 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 for purified water can be met by a water treatment unit, e.g.
MELAdem®55, which can be directly connected to the autoclave.
Provided the instruments to be sterilized are then also prepared carefully, stains on the load and soiling of
the autoclave itself can be prevented.
2.3.5 Electronic Parameter Control (EPS) __________________________________________________
The microprocessor in the Cliniklav®25 makes it possible to monitor pressure, temperature and time
continuously during a program by Electronic Parameter Control. The overall operating time can then be
optimised according the load and the temperature of the autoclave.
The process assessment and monitoring system in the program control compare current process parameters
with standard process data and monitors the process relative to limit values for temperatures, times and
pressures. This makes it possible to identify faults as they occur, and provides quality assurance for the
sterilization processes.
2.3.6 Vacuum drying ____________________________________________________________________
Vacuum drying ensures the best possible drying results for packed utensils (see also 11.4).
2.3.7 Documentation____________________________________________________________________
The electronic memory stores logs of the previous 40 programs.
For effective hard-copy documentation and for checking purposes, a MELAprint®42 printer can be connected
to print out a log immediately after completion of a program or to print out logs from the memory. If the
optional MELAtrace/MELAview documentation software is used with this autoclave, a Computer in the
doctor’s practice can be used to document the sterilization cycles, and to archive the required data. In this
case, the data are transmitted from the autoclave via a serial interface to the Computer in the practice (the
serial cable is delivered with the software).

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3 Installation and Initial start-up
For preparing the installation and when you are setting-up and installing the autoclave, please consult the
separate instructions leaflet "Installing the Cliniklav®25".
3.1 Power supply _______________________________________________________
Switch on the power using the switch on the front of the autoclave (bottom of the door housing cover in the
middle). The autoclave is in the initial state:
Time (h:min:s)
Pressure of chamber(bar)
(Steam)-temperature (°C)
Program Start-Stop
14:27:12
0,02bar 25°C
Fig. 4: View of the initial state of display
3.2 Connection of a water treatment unit ____________________________________
It is possible to connect a water treatment unit to the autoclave to directly supply it with
distilled/demineralized water. Instead of connecting the autoclave to a water storage container, the feed pipe
for distilled/demineralized water is directly hooked up to the water treatment unit.
For additional information on the application of the sterilization programs, please refer to section 7.4.
The MELAdem®55 is ideal as choice for the water treatment unit: It has been designed to 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 treatment unit. If you decide,
however, to use a water treatment unit made by another manufacturer, make especially sure that the system
provides enough water in sufficient quality. We always recommend that you first coordinate with the MELAG
company before buying another water treatment unit.
3.3 Vacuum test ________________________________________________________
In order to check the operation of the autoclave in the course of the initial start-up, after long periods without
being used, or after moves, as well as periodically during routine use, a vacuum test should be carried out
monthly to check for leaks.
The vacuum test should be carried out as follows, preferably on the cold autoclave:
Operation
Display message
1.
Switch on at mains,
then the display will
show the basic
parameters.
2.
Press the "Program"
key several times until
the display shows
"Vacuum test"
Close the door
4.
Press the key "Start -
Stop"
5. The evacuation
pressure has been
reached.
The equilibration
period
begins
Program
Start-Stop
Vacuum test
Program
Start-Stop
Vacuum test: Start
Pressure 980mbar
Program
Start-Stop
Vacuum test 00:00
Pressure 80 mbar
Program
Start-Stop
14:27:12
0.02 bar 25°C

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6.
After waiting for the
equilibration (5 min) the
measuring period starts
(running here e.g. for 7
min 52s)
7.
After the measuring
period (10 min) the
chamber is ventilated
and …
… then the leakage
rate is displayed (if the
option "Immediate
output" is set to "YES"
and a printer or another
output medium is
connected, a log will
also be printed)
The display shows
"Last batch number" in
alternation 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 is above the limit value (>1.3 mbar/min), then the display (and the log) will also show
"Test unsuccessful". In this case, follow the instruction in Section 9.1.
Program
Start-Stop
Vacuum test
Program
Start-Stop
Leak rate 0.2 mbar
Program
Start-Stop
Ventilate
-0.56 bar 25 °C
Program
Start-Stop
Vacuum test 07:52
Pressure 82 mbar
Last batch number 3
Quit with button '+'
Program
Start-Stop
Open door
please
Program
Start-Stop

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3.4 Bowie & Dick test ____________________________________________________
The Bowie & Dick test serves as proof of the steam penetration of porous materials such as textiles.
Diverse test systems are offered by specialist dealers for the Bowie & Dick test. Perform the test according to
the manufacturer's information to the appropriate test system. We recommend e.g. the Bowie & Dick test
packet from 3M No. 1300.
Evaluation is performed following sterilization and removal of the linen test package from the autoclave.
How to start the Bowie & Dick test program:
1. Switch on the autoclave at the mains. The display switches into its initial state.
2. Select the "Bowie & Dick test" program by pressing the "Program" key repeatedly.
3. Press the "Start/Stop" key to start the program.
After a successful program run, the last batch number is displayed, alternating with the message "Quit with
button ’+’." You can open the door after pressing the '+' key.
NOTE
Treatment indicator strips often exhibit differing intensities in the colour change indicating a different length of
storage of the manufacturer batches or other influences. Of crucial importance for evaluating the 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 an equal distribution of colour change, the
ventilation of the sterilization chamber is without fault.
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.
3.5 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" and a relevant load. After loading the autoclave and selecting
the program with the "Program" key, the sterilization is started by pushing the "Start/Stop“ key. If the program
runs correctly, the following message will appear on the display (see section 4.9).
Universal-Program
run succesfully
Program
Start-Stop
in alternation with:
Last batch number 4
Quit with button '+'
Program
Start-Stop
If the option "Immediate output YES" has been selected for a log printer or another output medium, a log of
the program run will be printed.
Programm
Start-Stop
Bowie & Dick Test
134°C 2.2bar 3,5’

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3.6 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.
3.7 Validation __________________________________________________________
In accordance with EN 17665, the sterilization process should be validated before beginning routine
operation with the autoclave.
4 Sterilization
4.1 Supply with fresh purified feed water/cooling water ______________________
The autoclave automatically monitors the availability of cooling water and purified water, as well as the
quality of the distilled/demineralized water before starting a program.
In order to allow an immediate program start and to avoid malfunction messages or interruptions of programs
(see Sections: 9.1 and 9.2):
•Before the first sterilization at the start of the working day, check that the water supply is turned on (water
tap),
•If purified feed water is drawn from a storage container, check the water level, and if necessary fill up with
purified water of appropriate quality (see section 7.4),
•If the feed water is drawn directly from a MELAdem®55 water treatment unit, check that its water supply
is turned on in good time (this may be up to an hour before starting a sterilization program), if the water
supply has been turned off over night, for example.
•For routine operation, please refer to the information contained in section 10.
4.2 Preparation of instruments ____________________________________________
MELAG non-rusting materials
All parts of the Cliniklav®25 which come into contact with steam are made of non-rusting material. The
autoclave chamber and the steam conducting parts are made of stainless steel, the door is made of
anodised aluminium and the threaded fittings and solenoid valves are made of brass.
Drag-in rust
The use of non-rusting materials excludes 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 brought in from other sources. It should be borne in mind that rust can form
even on best quality stainless steel instruments, for example as a result of improper treatment with chemical
cleaning agents or disinfectant during preparation for sterilization.
Preparations of items for sterilization
The example of drag-in rust shows how important it is to prepare items properly for sterilization, and
particularly the following points.:
Handpieces and angles should be cleaned before the sterilization in accordance with the manufacturers
instructions and maintained (e.g. oiled). The remaining instruments should be disinfected and cleaned
immediately after use in accordance with UVV/VBG 103 with a disinfectant and/or cleaning solution. The
solutions should be used in the correct concentration and care should be taken to observe the immersion
times precisely!
It is advisable to make use of appropriate cleaning aids such as ultrasonic cleaning units, cleaning and
maintenance equipment for handpieces 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. In particular, locks, joints and hinges should be thoroughly cleaned with a brush.
Cleaning and disinfecting agents should be washed off the instruments thoroughly in running water, again
with a brush. Residues of cleaning and disinfectant chemicals must not find their way into the autoclave,
since they can lead to corrosion! Swill finally with demineralized water and then dry the instruments.
Turbines and transfer instruments should be oiled in accordance with manufacturer's instructions in order to
ensure a long life for these components.
Brand-new instruments
The cleaning procedures described above are also necessary for brand-new instruments, since these often
carry very small amounts of oil, fat and soiling from the manufacturing process.

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Note: The instructions of the instrument manufacturers concerning first-time sterilization and re-sterilization
should be followed carefully.
4.3 Loading the autoclave _______________________________________________
It is of crucial importance for effective sterilization and good drying that the autoclave is loaded properly.
Be sure to observe the following basic instructions when loading the autoclave.
Loading variations
Article
MELAG Art.-No.
Mounting for up to 4 trays or 2 instrument baskets
02517
Tray
00250
Instrument basket
00260
Max. 3 mountings for each 6 standard tray cassettes
02518
Standard-tray cassette, perforated with filter sheet
00289
All mountings are also suitable for accommodating the MELAG sterilization containers Type 15K, M, G,
Type 17R, K, M, G; Type 23R, M, G, Type 28M, G.
In this case, we recommend using the additionally available chamber floor overlay (MELAG Art.-No. 46890),
designed to protect the sterilization chamber from scratching.
Mounting
Normally, the autoclave should be used in conjunction with a mounting, since this ensures that steam
penetration and drying are as good as possible. In exceptional situations (e.g. when using sterilization
containers from other manufacturers), and after consultation with your specialist dealer or with MELAG, the
mounting can be removed and the container can be placed directly in the autoclave chamber.
Trays
Trays for objects which are to be sterilized must be perforated, in order to allow condensate to run away.
MELAG trays are recommended. If you use dishes or trays without perforations, then the objects being
sterilized will not dry properly.
Closed 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 condensate can run out. All MELAG sterilization
containers meet these requirements with perforations on two sides and filter-cloth-inlays.
Sterilization containers which only have perforations on the top only allow limited drying.
If sterilization containers are stacked in the autoclave, it is important to ensure that the perforations are not
blocked.
Transparent sterilization packaging
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.
If seals split open during sterilization it may be necessary to increase the length of the sealing impulse or to
use a double-seal.
Standard tray-cassettes sealed in MELAfol®(250 mm wide) must be taped and clasped additionally to
ensure that the side-seals do not split open.
Multiple wrapping
The pulsed vacuum method means it is possible to use multiple wrapping.
Maximum loads
Loads should not exceed 15 kg of instruments or 7 kg of textiles.
Mixed loads
If mixed loads of textiles and instruments are to be sterilized, then as far as possible the textiles should be
above the instruments and direct contact with the instruments should be avoided.
Inclusion of textiles and instruments in the same sterilization container is not desirable.
Textiles should never come into direct contact with the walls of the chamber.
If different types of packaging are included in a load, then:
•Instruments and sterilization containers should be at the bottom
•Transparent and paper sterilization packaging should be at the top (but lower than textiles)

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Suitability for sterilization
Relevant information provided by manufacturers of instruments and textiles about sterilization should be
strictly observed.
4.4 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" or the "Gentle-Program" must be used).
By pressing the "Program” selection key it is possible to review the display of the following programs for
selection:
Program name/Display message
Parameter/Application
Universal-Program.at 134°C, 2 bar, and a
sterilization time of 5.5 min
Sterilization of all types of wrapped items, in
particular instruments, or mixed loads
(unwrapped/wrapped)
Quick-Program B at 134°C, 2 bar and a
sterilization time of 5.5 min.
Sterilization for unwrapped items, simple wrapped
(5.5 kg) instruments or porous load (4 kg) for rapid
re-use.
Quick-Program S at 134°C, 2 bar and a
sterilization 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.
Sterilization of all types of wrapped items, in
particular large amounts of textiles or
thermosensitive materials (plastic, rubber), or
mixed loads (wrapped/unwrapped)
Prion-Program (a special Universal-Program) at
134°C, 2 bar, and with sterilization time extended
to 20.5 min, for sterilization of wrapped items,
especially instruments and/or mixed loads (i.e.,
packed and unpacked). This program is
recommended for sterilization of instruments used
in situations in which the danger of infection by
pathologically modified proteins is suspected: for
example, Creutzfeld-Jacob and BSE).
Bowie&Dick Test at 134°C, 2 bar and a
sterilization time of 3.5 min
Used to check the operation of the autoclave
(Steam penetration of special indicators)
Vacuum test
Used to check the autoclave for leaks,
from a cold start
Basic display (no program selected)
Program
Universal-Program
134°C wrapped
Program
Quick-Program S
134°C unwrapped
Program
Gentle-Program
121°C wrapped
Program
Bowie & Dick Test
134°C 2.2 bar 3.5‘
Program
Vacuum test
Program
15:31:33
0.02 bar 22°C
Program
Prion-Program
134°C wrapped 20'
Program
Quick-Program B
134°C

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4.5 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.
DIN EN 285 (for steam sterilizers) recommends preheating before beginning the actual sterilization cycle.
4.6 Selecting extra drying ________________________________________________
The standard drying times for the various programs provide adequate drying if the autoclave has been
loaded correctly (see section 4.3). Nevertheless, with certain loads residual moisture may remain. By
selecting the "Additional drying" function, the drying time can be extended by 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 drying time.
4.7 Opening and closing the autoclave door _________________________________
To close the autoclave door, lightly press it closed, then press the door opener to position 2 shown below.
The door is properly closed when the door opener remains depressed until the motor sound in the door
stops.
Position 1: OPEN
Position 2: CLOSE
1
2
Fig. 5: Door opener
4.8 Program start _______________________________________________________
Press the "Start-Stop" key once the desired program is shown on the display. The availability of cooling
water and feed water will be checked automatically, with a conductivity measurement.
Program
Start-Stop
Start
Fig. 6: Program start message
At the start of the Quick-Program S there will be an additional message "Warning! Only unwrapped
instruments“. This message must be acknowledged by pressing "Start“ again.
Program
Start-Stop
Additional drying
selected

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4.9 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
(removal of air) until the appropriate
evacuation pressure is reached, followed
by steam introduction up to slightly above
atmospheric pressure.
Display show pressure in chamber and
steam temperature
2.
Phase 2 and following
Depending on the program chosen and
the temperature of the chamber at the
start of the temperature, additional cycles
may be necessary to ensure that air is
evacuated and superheated steam enters
the items being sterilized.
3.
Heating phase
A heating-up phase follows. The
continuous introduction of steam raises
pressure and temperature in chamber to
the values needed for the program.
4.
Sterilization phase
When the required 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 completion of the sterilization time,
the pressure is released and the steam
generator emptied.
Pressure and temperature fall.
6.
Drying phase
After pressure release the drying phase
begins.
At this point it is possible to stop the
program without this leading to a fault
being reported, since the sterilization
itself is now completed. However, with the
exception of the "Quick-Program S", the
drying phase should be allowed to run to
completion.
7.
Ventilation
After the drying, the chamber is
ventilated, with pressure equilibration.
Program
Start-Stop
Ventilation
-0.12 bar 60°C
Program
Start-Stop
1. Fractionation
-0.085 bar 22°C
Program
Start-Stop
2. Fractionation
-0.85 bar 70°C
Program
Start-Stop
Heat up
1.80 bar 117°C
Program
Start-Stop
Sterilization
still 2 min, 12s
Program
Start-Stop
Sterilization
2.18 bar 135°C
Program
Start-Stop
Press. release
0.85 bar 96°C
Program
Start-Stop
Immed. Removal
press ‚STOP‘
Program
Start-Stop
Vacuum drying
sin. 1‘ -0.9 bar 99°C

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8.
Program end
After ventilation of the chamber the
program is completed.
If a printer or another output medium is
attached and option "Immediate output" is
set to "YES" , the log will be printed-out
immediately.
After pressing the '+' key the door is
unlocked and …
9
.
Open the door
… can be opened after the display
message "Please open door" is
displayed.
4.10 Manual termination of program_________________________________________
4.10.1 Terminate before beginning of drying_________________________________________________
A program can be terminated at any time by pressing the "Start-Stop" key. If the program has not yet
reached the drying phase then the items will be non-sterile (or for some programs non-disinfected)!
Warning
The standard DIN EN 285 prescribes very good drying (residual dampness < 1% for textiles/
0.2 % for metals), which cannot be guaranteed upon program abort (see above).
In such a
case, the requirements placed on sterilization by DIN EN 285 are not met.
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 their own heat during cooling.
Warning
Depending on the previous operation of the autoclave steam may be released, when the door of
the autoclave is opened.
Steam may escape when the autoclave door is opened.
If the sterilization phase of the program had not been completed, then it is advisable to carry out an empty
sterilization run before re-using the autoclave.
Operation
Display message
1.
Press the "Start-Stop" key
To confirm, press the "Start-Stop" once
again within 5 seconds.
If no confirmation is given then the
program resumes normally.
2.
If confirmation is given then the program
stops.
The pressure inside the autoclave will
then be equilibrated, either by pressure
release, or by
ventilation (if vacuum inside).
Program
Start-Stop
Open door
please
Program
Start-Stop
Universal-Program
run successfully
Program
Start-Stop
Last batch number 3
Quit with button '+'
Program
Start-Stop
Stop Program?
Press ‚Stop‘
Program
Start-Stop
Pressure release
1.52 bar 112°C
Program
Start-Stop
Program
stopped

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3.
After pressure equilibration, the display
will alternately show the messages
"Program stopped" and an offer to quit
the program termination.
4.
To undo the program termination, press
the " – " button.
- Otherwise, the display for the selected
program reappears.
4.10.2 Terminate during drying ____________________________________________________________
A program can also be terminated during the drying phase. Since in this case the sterilization has been
completed, the items in this case can be treated as sterilized.
However, depending on the state at which the drying program is terminated, the load may not have dried
sufficiently, and wrapped items in particular may not be dry enough for sterile storage. We therefore
recommend that you do not interrupt the drying process for wrapped items in the "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 down.
Warning!
If the drying process is interrupted than steam may be released when the door of the autoclave
is opened.
Operation
Display message
1.
The autoclave is in the drying phase.
The display shows the drying time …
… alternately with the option to terminate
the drying phase.
2.
Press the "Start-Stop" key.
To confirm, press the "Start-Stop" once
again within 5 sec.
If no confirmation is given then the
program resumes normally.
3.
If the "Start-Stop" key has been pressed
again to confirm then the program
terminates.
Program
Start-Stop
Stop/End
0.02 bar 88°C
Program
Start-Stop
Acknowledge
with button '–'
Program
Start-Stop
Universal-Program
121°C wrapped
Program
Start-Stop
Immed. removal
press ‚Stop‘
Program
Start-Stop
Vacuum drying
sin. 3‘ –0.9 bar 68°C
Program
Start-Stop
Stop program?
press ‚Stop‘
Program
Start-Stop
Drying
stopped

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4. This is followed by ventilation of the
autoclave chamber.
After the ventilation of the chamber the
display shows that the program has been
successfully completed …
… in altern
ation with "Last batch number
4 - Quit with '+' ".
If a printer or another output medium is
connected and the option "Immediate
output" is set to "YES" a log with
confirmation that the drying process has
been terminated is printed out.
By pressing the key '+' the door is
unlocked …
… and can be opened after the message
"Open door please" is displayed.
4.11 Removing the sterilized items__________________________________________
Warning
Be careful when removing the sterilized items! Touching the metal surfaces can lead to
burns
. Always use the appropriate aids to lift the trays or wear suitable hand protection.
4.12 Sterile storage ______________________________________________________
After removing wrapped sterile items, the wrapping should be checked for any signs of damage. If it is
defective (e.g. split seals) then the sterilization of the items must be 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 interrupted before its completion and the autoclave has been
properly loaded (see Section 4.3). Directly after sterilization there may still be residual condensation on the
items or the container. Because the items are hot on removal, this will usually evaporate quickly. The
German industrial standard DIN 58953 Part 7 Section 7 contains the following comment about residual
moisture on paper wrapping or transparent sterilization paper after sterilization: "...small amounts of water on
the wrapping are unproblematic, provided they have evaporated within 30 minutes after removal from the
steam sterilizer....."
After cooling, wrapped sterilized objects should be stored in a place where they are protected from dust
(e.g. instrument cupboard). Given proper storage, the sterilized objects can be stored up to 6 months
according to DIN .8953-8:2003.
Program
Start-Stop
Open door
please
Program
Start-Stop
Universal-Program
run successfully
Program
Start-Stop
Ventilation
-0.52 bar 112°C
Program
Start-Stop
Drying
stopped
Program
Start-Stop
Last batch number 4
Quit with '+'