Dear Doctor:
Thank you very much for the trust which you have shown by purchasing this autoclave.
For more than 50 years now, MELAG — a medium-sized family-owned and -operated
company — has specialized in the production of sterilization equipment for medical
practice. During this period, MELAG has succeeded in becoming a leading manufacturer
of sterilization equipment. More than 355 000 MELAG units sold throughout the world
testify to the exceptional quality of our sterilizers — which are manufactured exclusively in
Germany.
As all other MELAG products, this autoclave was manufactured and tested according to
strict quality criteria. Before placing this unit into operation, please read this Operating
Manual carefully. The long-term functional effectiveness and the preservation of the value
of your autoclave will depend on careful preparation of instruments before sterilization,
and on proper care of the unit.
The staff and management of MELAG
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
1
DESCRIPTION OF THE UNIT....................................................................................................................4
1.1 Views of the unit...................................................................................................................................4
1.2 Control - Panel .....................................................................................................................................5
2.1 Setting up the autoclave.......................................................................................................................8
2.2 Transport ribbons.................................................................................................................................8
3.1 Initialising the printer............................................................................................................................9
3.1.1 Connecting the external MELAprint®42 printer.............................................................................9
3.1.2 Initialising the printer / Immed. print-out? Yes/No.........................................................................9
3.2 Test run................................................................................................................................................9
4 INSTRUCTIONS FOR ALL STERILIZATION PROCEDURES................................................................10
4.1 Electricity and water supplies.............................................................................................................10
4.1.1 Feed water aqua dest / aqua dem..............................................................................................10
4.1.2 Power supply ..............................................................................................................................11
4.2 Preparing instruments for sterilization................................................................................................11
4.3 Loading the autoclave........................................................................................................................12
4.4 Closing the door.................................................................................................................................13
4.5 Program selection ..............................................................................................................................13
4.6 Program start......................................................................................................................................14
4.7 Program progress ..............................................................................................................................14
15 x 38 cm, 7 Litres 18 x 42 cm, 11 Litres 23 x 45 cm, 19 Litres
2 Kg 3 Kg 4 Kg
100 Gr. 150 Gr. 200 Gr.
150 Gr. 300 Gr. 500 Gr.
121 °C, 1bar, Sterilization time: 20 min
134 °C, 2bar, Sterilization time: 5 min
_________________________________
1.4.1 Conformity to european standard____________________________________________________
The autoclaves MELAtronic
Steam Sterilizers EN 13060 for autoclaves with sterilization cycle of the type „S“ and „N“ (see section .4.5
and 9.2) .
Regarding the sterilization performance the autoclaves MELAtronic
the sterilization of unwrapped and solid instruments, for the sterilization of single wrapped solid instruments
and also for the sterilization of small amounts of single wrapped textiles. Thermo – electrical Tests according
EN 13060 and additional bacteriological tests have approved this perfomance.
With the fractionated gravity system which is used steam flows into and then out of the autoclave to ensure
effective penetration of the items to be sterilized by saturated steam.
This makes it possible to carry out demanding sterilization tasks rapidly and reliably, such as for example the
sterilization of wrapped instruments or textiles.
1.4.3 Operating range for sterilization_____________________________________________________
The autoclaves MELAtronic
134°C: the “Universal Program” (for wrapped objects), the “Prion Program” (a special Universal Program),
the “Quick Program” for unwrapped items. The “Gentle Program” is a sterilization program for textiles and
rubber articles at 121°C.
The powerful steam generation in the sterilization chamber makes it possible to sterilize large loads of
instruments or textiles in a short time. This system of steam generation means that excess temperatures in
the sterilized chamber are not possible.
15EN, 17EN und 23EN fulfill the stipulations of the european standard for Small
15EN, 17EN and 23EN are usable for
®
15EN, 17EN and 23EN feature three sterilization programs for temperatures at
Page 6
®
Operating manual for MELAtronic
1.4.5 One-way / Closed-loop system / Conductivity measurement______________________________
The autoclaves MELAtronic
circulatory water system. This means that the water evaporated during each sterilization process is
condensed and returned to the water storage tank. This takes place during sub-atmospheric pulsing, and
during pressure release. This type of operation is effective for sterilization rates of approx. 2 … 3 sterilization
cycles per work day, if sufficiently long pauses between sterilization are observed. In work with a circulatory
water system, however, it is very important to ensure that the instruments to be sterilized have been
especially carefully cleaned and rinsed before sterilization. In addition, the water should be checked for dirt
and debris every day, and the water must be changed at least once a week.
If the sterilizer is used often, the water in the water storage tank becomes extremely hot, so that complete
condensation in the tank is not possible, and steam will exit from the vent openings (Fig. 1, Pos. 13) on the
back wall of the autoclave. Under these conditions, an external condensate tank (MELAG article no. 00356)
can be connected to the autoclave, and the condensing coil (Fig. 1, Pos. 18) can be removed from the water
storage tank. The autoclave will now operate with a single-use (non-reusable) water system, and the
evaporated water for each sterilization will be condensed in the external condensate tank. This configuration
has the advantage that the water in the storage tank will not become too hot, and the steam will not be
ejected from the autoclave. Another advantage of this installation alternative is that impurities dissolved in
the steam will not get into the water of the storage tank – and this means that clean distilled or demineralized
water will once again be used for sterilization in the following program cycle.
An integrated electrical conductivity sensor monitors the quality of the demineralized or distilled water used
to generate the steam. Using the recommended one-way operation for the autoclave, the increased
consumption of demineralized or distilled water can be provided by using a water purifier such as the
MELAdem
®
40, MELAdem®47 or the MELAdest®65.
Provided that the instruments are prepared carefully for the sterilization, stains on the load and soiling of the
autoclave itself can be prevented.
®
15EN, 17EN and 23-EN operate in the standard installation mode, as a
15 / 17 / 23EN
1.4.6 Electronic Parameter Control EPS ___________________________________________________
The microprocessor used in the MELAtronic
®
15EN, 17EN and 23EN 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 process.
By activating the "pre-heating" function, the cold autoclave chamber can be warmed up before sterilization,
or the temperature can be maintained between sterilization runs. This reduces the duration of cycles and
considerably reduces the formation of condensation, thus improving drying results with slightly opened door.
The memory of the electronic control system stores records of the previous 40 programs.
For effective hard-copy documentation and for checking purposes a MELAprint
to print out a record immediately after completion of a program, or to print out records from the memory.
By connection of a PC, the program MELAwin
®
can also transfer the records to the PC, for permanent
®
42 printer can be connected
archiving of all results, and for printing out these results as needed.
Page 7
2 Installation
2.1 Setting up the autoclave
The autoclave should be set up in a dry place which is protected against dust.
The base should be stable, and able to support the weight of the autoclave. At the same time, the work
surface must provide convenient access to the autoclave, and the display must be clearly visible.
The space required by the autoclave can be seen from the external dimensions (as in Section 1.1). A
minimum additional space of 5 cm should be allowed on either side and above the autoclave in order to
ensure that heat can escape. If the additional condensate container shall be connected to the autoclave you
need an adequate space below the autoclave for the container.
The electrical power supply should be a separate 230V AC circuit with a 16 A fuse and optionally protected
with a 30 mA circuit breaker.
Should it be decided at some stage to install an automatic one-way water system, it is necessary to connect
the condensate container as an option. The condensate container must stand below the autoclave and the
outlet pipe must be without bends and twists which could prevent water flowing out freely.
For the supply with demineralized / distilled water from the integrated water storage tank (Fig. 1 Pos. 26) you
need at least a space of 30cm or more above the autoclave.
______________________________________________
2.2 Transport ribbons _____________________________________________________
Take the autoclave out of the packaging by means of the transport ribbons. The blue ribbons themselves are
each removed by undoing two retaining screws, which must then be screwed firmly back in place without
washers. Therefore you need the TORX-key, delivered with the autoclave
In order to ensure that the autoclave will work reliable, the autoclave should be installed in a horizontal
position (this should be checked with a spirit level at the chamber flange) as shown in the pictures below.
Fig. 3 Levelling the autoclave with a spirit level
2.4 Mains power supply
_________________________________________________
Page 8
The electric cable of the appliance is plugged into a mains socket rated at 230 V, 50 Hz. The power rating of
the MELAtronic
avoid overloading the electricity supply, we recommend using a separate electrical circuit fitted with a 16 A
fuse and optionally protected with a 30 mA circuit breaker.
®
15EN and the MELAtronic®17EN is 1500W, of the MELAtronic®23EN 1600W. In order to
2.5 Filling the water storage tank__________________________________________
Remove the lid of the housing (Fig.1 Pos 27) and the lid of the water tank (Fig.1 Pos. 28) below. Fill the
water tank with ca. 3 Litres of aqua dest / aqua dem. Do not fill more water into the tank than up to the "MAX"
mark (Fig.1 Pos. 16). The cooling coils in the water storage tank should always be covered with water. This
will allow the steam flowing out to condense. It will also prevent and problems from the steam, and will
eliminate excessive consumption of distilled or demineralised water. For this reason, be sure to top up with
distilled or demineralised water as soon as necessary. Or, better: drain out the remaining water through the
water drain tap (Fig. 1, Pos. 6) and refill with fresh distilled or demineralised water up to the MAX mark.
®
Operating manual for MELAtronic
15 / 17 / 23EN
2.6 Connecting the external Condensate container (option)
To operate the autoclave with a single-use (non-reusable) water system (one-way system), and to avoid
discharge of steam during frequent sterilization work, an external condensate tank (MELAG article no.
00356) can be connected to the autoclave. This external condensate tank is not part of the equipment
provided originally with the autoclave. Please proceed as follows to connect the condensate tank to the
autoclave:
Remove the blind cap from the connection point for the external condensate tank (Fig. 1, Pos. 11), on the
back wall of the autoclave. Connect the drain pipe (supplied with the external condensate tank) to the
connection point, and tighten it securely with the coupling ring. Fill up the external condensate tank up to the
MIN mark with ordinary tap water, and place the tank under the autoclave.
Insert the free end of the drain pipe, as far as it will go, onto the plug-on coupling in the top of the external
condensate tank. The drain pipe should not have any kinks or dips, and it should lead continuously
downward (without any upward loops).
Finally, remove the condensing coil for the pressure release (Fig. 1, Pos. 18) in the water storage tank.
Remove this coil by pressing toward the rear the locking ring of the plug-in conne ctor for the condensate loop
(Fig. 1, Pos. 19). After removing this coil, store it safely where you can find it easily.
____________________
3 Initial start-up
3.1 Initialising the printer
3.1.1 Connecting the external MELAprint®42 printer _________________________________________
In order to document the progress of the sterilization programs, the printer MELAprint
to the MELAtronic
For the connection of the printer to the autoclave see section 6.2.1.1.1.
®
15EN / 17EN / 23EN. This printer is not included by delivery.
________________________________________________
®
42 can be connected
3.1.2 Initialising the printer / Immed. print-out? Yes/No ______________________________________
The initialising of the external printer (Registration in the electronic of the autoclave) is described in section
6.2.1.1.2. For the selection “ Immed. print-out? Yes (Preferred selection, after a cycle the print-out is made
automatically) see the description in section 6.2.1.3.
3.2 Test 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" button, sterilization is started by pushing the "Start/Stop“ button. If the
program runs correctly, the following message will appear on the display (see Section 4.7):
with the values for the maximum values for pressure and temperature. If the immediate printout option has
been selected for an external printer a record of the program run will be printed.
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.
IMPORTANT: If you connect an external condensate tank to the autoclave, be sure to remove the
condensing coil for pressure relief (Fig. 1 Pos. 1) from the water storage tank. Check the level of water in
the condensate tank every day, and empty this tank to prevent water from overflowing and causing
damage to the room. IMPORTANT: There is no automatic monitor for the level of condensate water.
The appliance is not suitable for sterilizing liquids.
Under current VDE-regulations, this appliances is not suited for use in areas where there are risks of
explosion.
The appliance 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.
Before opening the housing always disconnect from the mains power supply!
In order to ensure effective sterilization with the autoclave observe the instructions in this operating
manual, and in particular ensure that the loading of the autoclave is appropriate for the program
selected.
This device is designed to be operated outside the patient’s surroundings. This means that there must
be an interval of at least 1.5 metres between the device and the area where patients are being treated,
or where they otherwise stand or sit.
If error messages repeatedly occur during operation of the autoclave, then do not use the autoclave until
it has been repaired by authorized service personnel.
If the power cable is damaged, do not use the autoclave. Call authorized service personnel and have
them replace the damaged cable by an especially prepared cable.
4 Instructions for all sterilization procedures
4.1 Electricity and water supplies
4.1.1 Feed water aqua dest / aqua dem___________________________________________________
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 error reports or interruptions of programs check
before the first sterilization at the start of the working day, that the internal water supply has sufficient water
in the water storage tank. If necessary, refill with water of appropriate quality (see Section 8.3.3).
Before the first sterilization the quality of the feed water has to be checked by pressing the button „-“ after the
autoclave is switched on. Is the conductivity of the water higher than 65 µS/cm, the feed water has to be
exchanged and fresh aqua dest / aqua dem has to be filled into the water storage tank..
If the water storage tank is dirty, the water has to be drained and the water storage tank must be cleaned
bevor refilling the tank with fresh aqua dest / aqua dem (see also section 8.3.3).
________________________________________
Page 10
®
Operating manual for MELAtronic
4.1.2 Power supply ___________________________________________________________________
Switch on the power using the switch on the front of the autoclave (Fig.1 Pos.2). The autoclave is in the start
status:
Time (h:min:s)
Pressure of chamber (bar)
(Steam)-Temperature (°C)
14:27:12
0,02bar 25°C
Programm
Start-Stop
15 / 17 / 23EN
4.2 Preparing instruments for sterilization
MELAG - rust-free materials
All parts of the MELAtronic
rusting materials: the pressure chamber and the door of stainless steel, steam pipes of Teflon, and screws
and magnet-valves of bronze.
Film rust
The use of these materials means that no parts of the autoclave can initiate rust formation. Where rust does
attack the autoclave or instruments sterilized in it, tests repeatedly show that this has been brought into the
autoclave on instruments (film rust).
Even top-quality stainless steel instruments can form rust if they are not handled properly, e.g. if they are
treated with the wrong chemical cleaning or disinfecting agents.
Preparing items for sterilization
The example of the formation of film rust shows how important it is to prepare items properly before
sterilization.
Handpieces and contra-angles must be cleaned before sterilization and maintained (e.g. by oiling).
Other instruments must be disinfected and cleaned immediately after use in accordance with UVV/VBG 103,
or similarly strict national codes of practice in a disinfectant and / or cleaning solution at the correct
concentration for the correct length of time.
MELAG recommends the use of cleaning aids such as ultrasonic baths, cleaning and maintenance
equipment for handpieces for contra-angles, as well as thermo-disinfecting devices.
It is essential that the instruments are well cleaned in order to avoid dirt and contamination being separated
from the load in the autoclave and clogging filters, valves, and nozzles. In particular locks, joints, and hinges
must be cleaned thoroughly with a brush before sterilization. No traces of cleaning and disinfecting agent s
should be allowed to enter into the sterilization chamber of the autoclave, since this can give rise to
corrosion! The instruments should be swilled off with demineralized water and then dried off before bei ng
loaded in the autoclave. Turbines and handpieces must be oiled in accordance with the manufacturer's
instructions in order to ensure their long working life.
Brand-new instruments
The cleaning procedures described above must also be followed before sterilizing brand-new instruments.
These often carry small amounts of grease, oil and soiling from the manufacturing process.
Important: Carefully follow all instructions provided by manufacturers of instruments for the preparation of
their products for first-time sterilization and for subsequent sterilizations.
®
15EN / 17EN / 23EN which come into contact with steam are made on non-
__________________________________
Page 11
4.3 Loading the autoclave
It is of crucial importance for effective sterilization and good drying that the autoclave is loaded properly: In
the annex you will get information how to load the autoclave.
When loading the autoclave, take account of the following points:
Tray rack
Normally, the autoclave should be used in conjunction with a tray rack, 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
tray rack 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 get safe sterilization results and to
allow condensation to run away. MELAG-trays are recommended. If you use dishes or trays without
perforations, then the sterilization will not be safe and the autoclave will not dry properly.
Enclosed sterilization containers
Enclosed 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 MELAGsterilization containers meet these requirements with perforations on two sides a nd filter-cloth- inlays.
Sterilization containers which only have perforations on the top only allow limited drying and are not for the
use in the MELAtronic
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
vertically on the tray. For the MELAtronic
The packagings 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 impulse on the sealing
device or to use a double-seal.
Standard tray-cassettes sealed in MELAfol
ensure that the side-seals do not split open.
Maximum loads
Do not exceed the maximum loads of the autoclave.
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)
Liquids
The appliance is not suitable for the sterilization of liquids!
Suitability for sterilization
Relevant information provided by manufacturers of instruments and textiles about sterilization should be
strictly observed.
®
15EN / 17EN / 23-EN
_______________________________________________
®
®
15EN the foil holders (MELAG-Art.-No.: 00283) should be used.
®
(250 mm wide) must be taped and clasped additionally to
, then the items should if possible be stood
Page 12
®
Operating manual for MELAtronic
15 / 17 / 23EN
4.4 Closing the door
The door is closed by putting the door latch over the door beam and turning the door grip until the door is
closed. The display shows the message:
4.5 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" button 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
Universal - Program
134°C wrapped
Quick Program at 134°C, 2 bar and a sterilization
Quick - Program
134°C unwrapped
Gentle Program at 121°C, 1 bar, sterilization time
sterilization time of 3.5 min for the sterilization of
wrapped items, in particular solid instruments (no
hollows), or mixed loads (unwrapped / wrapped). The
maximum loads in section 1.3 must not be exceeded.
time of 5 min for the sterilization only of unwrapped and solid instruments (no hollows, no textiles) for
rapid re-use (drying can be interrupted manually). The
maximum loads in section 1.3 must not be exceeded.
20 min for the sterilization of all types of wrapped and
solid instruments items (no hollows), textiles or
thermolabile materials (plastic, rubber), or mixed loads
(wrapped/unwrapped) The maximum loads in section
1.3 must not be exceeded.
Prion Program (a special Universal Program) at
134°C, 2 bar, and with sterilization time extended to
20 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).
The maximum loads in section 1.3 must not be
exceeded.
15:31:33
0,02bar 22°C
Page 13
Loading...
+ 28 hidden pages
You need points to download manuals.
1 point = 1 manual.
You can buy points or you can get point for every manual you upload.