Melag 29-S User manual

Operating Manual
for the
Autoclave
Euroklav29 S
Dear Doctor: Thank you very much for the trust which you have shown by purchasing this autoclave. For 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 335 000 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
1.3 Technical data...........................................................................................................................................5
1.4 Performance features of this autoclave....................................................................................................5
1.4.1 Pulsed flow method..........................................................................................................................5
1.4.2 Operating range for sterilization.......................................................................................................5
1.4.3 Integrated steam generation............................................................................................................5
1.4.4 One-way/Closed-loop system/ Conductivity measurement/ Automatic water refilling..................... 5
1.4.5 Electronic Parameter Control EPS...................................................................................................6
1.4.6 Pressure pulsing drying....................................................................................................................6
1.4.7 Pre-heating....................................................................................................................................... 6
1.4.8 Documentation.................................................................................................................................6
2 INSTALLATION..............................................................................................................................................6
2.1 Setting up the autoclave...........................................................................................................................6
2.2 Transport ribbons......................................................................................................................................6
2.3 Levelling....................................................................................................................................................7
2.4 Mains power supply..................................................................................................................................8
2.5 Outlet connection for one-way water........................................................................................................8
2.6 Internal water supply with demineralized/distilled water...........................................................................8
2.7 Connection of a water purification system................................................................................................8
3 INITIAL START-UP.........................................................................................................................................8
3.1 Printer connection / Initialisation (optional)...............................................................................................8
3.1.1 Connecting the MELAprint
3.1.2 Initialisation of the printer / Setting up immediate print-out..............................................................8
3.2 Test run.....................................................................................................................................................8
3.3 Installation record......................................................................................................................................8
3.4 Safety instructions.....................................................................................................................................9
4 INSTRUCTIONS FOR ALL STERILIZATION PROCEDURES......................................................................9
4.1 Electricity and water supplies ...................................................................................................................9
4.1.1 Distilled or demineralized feed water...............................................................................................9
4.1.2 Power supply....................................................................................................................................9
4.2 Preparing instruments for sterilization ......................................................................................................9
4.3 Loading the autoclave.............................................................................................................................10
4.4 Closing the door......................................................................................................................................11
4.5 Program selection...................................................................................................................................11
4.6 Program start ..........................................................................................................................................12
4.7 Program progress...................................................................................................................................12
4.8 Print-out record .......................................................................................................................................14
4.9 Removing the sterilized items.................................................................................................................15
4.10 Sterile storage.........................................................................................................................................15
4.11 Sterilization frequency / pauses..............................................................................................................15
4.12 Manual termination of program...............................................................................................................16
4.12.1 Termination of sterilization .............................................................................................................16
4.12.2 Terminate drying ............................................................................................................................ 17
4.13 Reaction to warnings / error messages.................................................................................................. 18
4.14 Operational pauses.................................................................................................................................18
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42 ......................................................................................................... 8
5 CLOSING DOWN / TRANSPORT / REINSTALLATION .............................................................................18
Page 2
Operating-manual Euroklav
6 SPECIAL FUNCTIONS.................................................................................................................................19
6.1 Water quality (conductivity) / Chamber preheating temperature............................................................19
6.2 Selecting extra drying .............................................................................................................................19
6.3 Records / Load documentation...............................................................................................................19
6.3.1 Record print-out ............................................................................................................................. 19
6.3.1.1 External printer.....................................................................................................................19
6.3.1.1.1 Connecting the external MELAprint
6.3.1.1.2 Initialising the printer..............................................................................................20
6.3.1.2 Connection to an external PC..............................................................................................20
6.3.1.2.1 Installation................................................................................................................20
6.3.1.2.2 Downloading to a PC............................................................................................... 20
6.3.1.3 No printer............................................................................................................................. 21
6.3.2 Immed. print-out? Yes/No.............................................................................................................. 21
6.3.3 Printing out stored records.............................................................................................................22
6.3.4 Print all stored cycle records..........................................................................................................23
6.3.5 Display printer memory status .......................................................................................................24
6.3.6 Deleting cycle records....................................................................................................................25
6.3.7 Test print-out..................................................................................................................................26
6.4 Resetting date and time..........................................................................................................................27
6.5 Automatic preheating..............................................................................................................................29
6.6 Total load count ......................................................................................................................................30
6.7 Distilled / demineralized water supply.....................................................................................................31
6.8 Water-system..........................................................................................................................................32
6.9 Program modifications............................................................................................................................ 32
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42 printer.................................................... 19
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29-S
7 SPECIAL FUNCTIONS.................................................................................................................................33
7.1 What to do if the autoclave malfunctions...............................................................................................33
7.2 Malfunctions without display messages ................................................................................................33
7.2.1 No display.......................................................................................................................................33
7.2.2 Excessive water consumption........................................................................................................33
7.2.3 Poor drying.....................................................................................................................................33
7.3 Warning messages................................................................................................................................34
7.4 Error reports...........................................................................................................................................37
8 TAKING CARE OF YOUR AUTOCLAVE ....................................................................................................40
8.1 Preparation of instruments.....................................................................................................................40
8.2 Rust formation = Drag-in rust.................................................................................................................40
8.3 Taking care of the Euroklav
8.3.1 Cleaning.........................................................................................................................................40
8.3.2 Use of demineralized or distilled water..........................................................................................41
8.4 Checking the operation of the autoclave ...............................................................................................42
8.4.1 Safety with automatic monitoring...................................................................................................42
8.4.2 Periodical bacteriological testing (twice a year).............................................................................42
8.4.3 Maintenance recommendations.....................................................................................................42
9 ANNEX..........................................................................................................................................................43
9.1 Installation options.................................................................................................................................43
9.2 Additional technical data........................................................................................................................44
9.2.1 Capacity/Weight.............................................................................................................................44
9.2.2 External supplies............................................................................................................................44
9.2.3 Operational parameters .................................................................................................................44
9.2.3.1 Programs / Operation times.................................................................................................44
9.2.3.2 Energy / Water consumption ...............................................................................................44
9.3 Instructions on drying.............................................................................................................................45
9.3.1 Drying in sterilization containers....................................................................................................45
9.3.2 Textiles...........................................................................................................................................46
9.3.3 Instruments ....................................................................................................................................47
9.3.4 Loading the autoclave....................................................................................................................47
9.3.5 Loading containers with soft sterilization packing material............................................................47
9.3.6 Stacking sterilization containers.....................................................................................................48
9.3.7 Removing the sterilized items........................................................................................................ 48
9.3.8 Improving the drying.......................................................................................................................48
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29-S.........................................................................................................40
Page 3
1. Description of the unit
1.1 Views of the unit _____________________________________________________
15 14 13
1
16 17
Front-view
12
11
10 9 8 7
Rear-view
2 3 4
5 6
Side-view
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Fig. 1 Views of the Euroklav
1 Safety valve l 9 Fuses - 2 x 16 A / FF 2 Sterile filter 10 Power switch
water supply
4 One-way water outlet (3/4") 13 Door (left side hinge)
distilled water supply 15 Tank lid 6 Mains power cable 16 Outlet connection for wastewater 7 Adjustable front feet 17 Outlet for distilled / demineralized water 8 Serial data and printer port ( RS 232 )
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29-S
11 Overheating trip-switch, steam generator 3 Connection for internal distilled / demineralized 12 Sliding door lock
14 Control panel 5 Pipe connection for internal demineralized /
Operating-manual Euroklav
1.2 Control panel ________________________________________________________
2 x 20- alphanumeric LED-display, s program status, and parameters for basic and special functions
Fig. 2 Control panel Euroklav
Buttons for selecting, adjusting and displaying special functions: Printing, date/time, pre-heating, total loads, conductivity, re-setting
29-S
for sterilization programs/ test programs
and for selecting options (sub-menus) of the
1.3 Technical data _______________________________________________________
Sterilization space (diameter x depth ) : 25cm x 36cm
Electric power supply : 2500W / 230V AC / 13 A / 50....60Hz
Sterilization pressure / temperature : 2bar/134°C; 1bar/121°C Maximum load: : 3kg instruments or 0.5kg textiles
Further technical details are included in the Annex
howing
Program
Program selection
special functions
Start - Stop
Start - stop buttons to start and interrupt programs, drying, and to control special functions
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29-S
1.4 Performance features of this autoclave __________________________________
1.4.1 Pulsed flow method ______________________________________________________________
With the pulsed flow method which is used steam flows into and then out of the autoclave to ensure effective penetration of the items to be sterilized by superheated 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. The stream penetration can be tested by implementing a special test program for the Bowie & Dick Test, which is the standard test for large-scale sterilization. operations..
1.4.2 Operating range for sterilization ____________________________________________________
The Euroklav (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 an additional functional check of the autoclave by running the Bowie & Dick Test for steam penetration. The additional program "MELAsteam temperature of 136°C.
1.4.3 Integrated steam generation _______________________________________________________
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.
1.4.4 One-way/Closed-loo p system/ Conductivity measurement/ Automatic water refilling _________
The Euroklav and all dissolved impurities are led away at the end of every sterilization cycle, and fresh demineralized or distilled water is then used. This is particularly good for all the materials used. However, in some instances it is also important to use less water, and the Euroklav mode. In this case the used water flows from the left side of the double-chamber storage container over the separating wall into the right-hand chamber. This water is then used again in the next sterilization cycle. With the closed-loop operation it is important that the instruments to be sterilized have been very carefully washed and swilled in purified water. The water in the autoclave must also be exchanged once a week. An integrated electrical conductivity meter 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 a water purifier such as the MELAdem MELAdem Provided that the instruments are prepared carefully for the sterilization, stains on the load and soiling of the autoclave itself can be prevented.
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29-S features three sterilization programs for temperatures at 134°C: the “Universal Program”
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" is available as an option, and functions at a
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29-S can be operated in the tried and tested one-way system, in which steam, condensed water
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29-S can also be used in a water-conserving closed-loop
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37, which can be directly connected to the autoclave.
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47 or
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1.4.5 Electronic Parameter Control EPS ___________________________________________________
The microprocessor in the Euroklav
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29-S 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.
1.4.6 Pressure pulsing drying ___________________________________________________________
This method ensures good drying results even for wrapped instruments.
1.4.7 Pre-heating ______________________________________________________________________
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.
1.4.8 Documentation___________________________________________________________________
The electronic memory stores records of the previous 40 programs. For effective hard-copy documentation and for checking purposes a MELAprint
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42 printer can be connected to
print out a record immediately after completion of a program or to print out records from the memory.
2 Installation
When setting-up and installing the autoclave, please consult the separate instruction leaflet "Installing the Euroklav
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29-S".
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 appliance (unloaded weight 40 kg). The space required by the autoclave can be seen from the external dimensions (as in Section 1.1). A minimum additional space of 10 cm should be allowed on either side and above the autoclave in order to ensure that heat can escape. The electrical power supply should be a separate 230V AC circuit with a 16 A fuse. Should it be decided at some stage to install an automatic one-way water system, it is necessary to have a connection to the wastewater plumbing near the autoclave, preferably a wall outlet (NW 40) or a sink-trap (standard length of outflow pipe 2m, 16 mm width). The work surface on which the autoclave stands must be higher than the outlet, and the outlet pipe must be without bends and twists which could prevent water flowing out freely. At the same time, the work surface must provide convenient access to the autoclave, and the display must be clearly visible. The autoclave can be supplied with demineralized/distilled water from the integrated two chamber storage tank, with freshwater and wastewater chambers. Alternatively, the Euroklav external water purifier - MELAdem
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47 or MELAdem®37 (or an equivalent water purification system). However,
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29-S can also be connected to an
please note that this will require additional space.
2.2 Transport ribbons ____________________________________________________
Take the autoclave out of the packaging by means of the transport ribbons. The ribbons themselves are each removed by undoing two retaining screws, which must then be screwed firmly back in place without washers.
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Operating-manual Euroklav
2.3 Levelling ___________________________________________________________
In order to ensure that condensate can drain out of the autoclave (which is important if it is to operate properly) the appliance must have be higher at the front than at the back. The autoclave should first be installed in a horizontal position (this should be checked with a spirit level at the chamber flange) and then the front feet should be extended by giving them three (3) turns.
1
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29-S
Rear view
9
8
2
3
4
5
6
7
Fig. 3 Installation of the Euroklav
29-S with wall-mounted trap
1 Tank lid 2 One-way outlet 3 Connection for internal supply of demineralized/distilled water 4 Pipe link for internal supply of demineralized/distilled water 5 Y-connection with non-return valve (included in Item 6 ) 6 Wall-mounted trap (MELAG- Art.- No.: 37410) 7 Wall outlet (NW 40) 8 Supply line for external supply of demineralized/distilled water 9 Mains power supply
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2.4 Mains power supply __________________________________________________
The electric cable of the appliance is plugged into a mains socket rated at 230 V, 50 Hz. The power rating of the autoclave is 2500 W. In order to avoid overloading the electricity supply, we recommend using a separate electrical circuit fitted with a 16 A fuse and optionally protected with a 30mA circuit breaker.
2.5 Outlet connection for one-way water ____________________________________
The connection for the one-way water outlet at the back of the appliance is connected to the drainage system of the building by means of the outlet pipe (textile-reinforced transparent pipe, DN16). It is important that the pipe should have a steady downward gradient, without twists and kinks. When connecting to a separate outflow pipe NW40, a wall-mounted trap should be used (MELAG Art.-No. 37410, see Fig. 3).
2.6 Internal water supply with demineralized/distilled water ____________________
The internal supply of demineralized/distilled water is used for the autoclave in closed-loop operation (see page 44, Fig. 4), the water is extracted from the right chamber of internal water storage tank. The autoclave is supplied with a pipe link with two swivel connections installed to connect the storage tank outlet with the inlet for demineralized/distilled water. To fill the tank the lid must be removed and the demineralized/distilled water of suitable purity filled into the right-hand chamber until the Max mark.
2.7 Connection of a water purification system _______________________________
The autoclave can be connected directly to a water purification unit which provides the demineralized or distilled water required (see page 44, Fig. 4). Instead of connecting the feed water inlet to a storage container, it is simply connected directly to the water purification unit. The reverse-osmosis system MELAdem the quantity and quality of water needed for the Euroklav Detailed instructions on the installation of these water purification units are provided in their operating manuals. When connecting water purification systems from other manufacturers it is very important to ensure that they are able to provide sufficient amounts of water at the required purity. You are generally advised to consult MELAG first.
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47 and the ion-exchanger MELAdem®37 are ideally suited to provide
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29-S.
3 Initial start-up
3.1 Printer connection / Initialisation (optional) _______________________________
3.1.1 Connecting the MELAprint®42 ______________________________________________________
The autoclave can be connected to an external printer, the MELAprint with the autoclave. In order to connect the printer to the autoclave follow the description in Section 6.3.1.1.1.
3.1.2 Initialisation of the printer / Setting up immediate print-out ______________________________
Initialise the external printer (registering with the processing unit of the autoclave) as described in Section
6.3.1.1.2 .In order to select the immediate print-out option, which means that a record of each sterilization is printed out automatically as soon as it has finished, proceed as described in Section 6.3.1.3.
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.
Universal-Program
successfully
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42. This is not supplied as standard
Program
Start-Stop
3.3 Installation record ____________________________________________________
As documentation that the autoclave has been set-up properly, an installation record 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.
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Operating-manual Euroklav
3.4 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
If you install the optional water purifier MELAdem
water leak detector (see installation details Section 2).
If you intend to install a water purification unit from another manufacturer, then consult MELAG before you
do so.
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 select ed.
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47 or MELAdem®37 we recommend the installation of a
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29-S
4 Instructions for all sterilization procedures
4.1 Electricity and water supplies __________________________________________
4.1.1 Distilled or demineralized feed 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 error reports or interruptions of programs (see Sections: 7.3 and 7.4) : Before the first sterilization at the start of the working day, check that the internal water supply has
sufficient water in the right chamber of the double internal tank. If necessary, refill with water of appropriate quality (see Section 8.3.2).
If the feed water is drawn directly from a MELAdem
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.
4.1.2 Power supply ____________________________________________________________________
Switch on the power using the switch on the front of the autoclave (bottom right). About 15 seconds after the message "Please wait Door release“ the appliance is in the start status:
(Steam)-Temperature (°C)
Time (h:min:s)
Pressure (bar)
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47 water purifier, check that its water supply is turned
Program
Start-Stop
14:27:12
0.02bar 25°C
4.2 Preparing instruments for sterilization ___________________________________
MELAG - rust-free materials
All parts of the Euroklav 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
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29-S which come into contact with steam are made on non-rusting materials: the
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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 agents 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 being 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.
4.3 Loading the autoclave ________________________________________________
It is of crucial importance for effective sterilization and good drying that the autoclave is loaded properly: When loading the autoclave, take account of the following points:
Tray rack
For the Euroklav Mount "B" (MELAG-Art.-No.: 40234) for up to 4 trays or 4 standard tray-cassettes. Mount "C" (MELAG-Art.-No.: 40232) for up to 6 trays or 3 standard tray-cassettes. Both types of tray rack are also suitable for the MELAG-sterilization containers Type 15K,M,G; Type 17K, Type 17R; Type 23R Type 28M,G). 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. For the sterilization of instruments sealed in transparent sterilization wrapping, it is recommended that you use the foil stand MELAG-Art.-No.: 22410. This contributes considerably to the drying process for such wrapped instruments.
Trays
Trays for objects which are to be sterilized must be perforated, in order to allow condensation to run away. MELAG-trays are recommended. If you use dishes or trays without perforations, then the objects being sterilized 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 MELAG-sterilization containers meet these requirements with perforations on two sides and filter-clot h- 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 vertically on the tray, or sterilized in foil holders (MELAG-Art.-No.: 22410). 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 impulse on the sealing device or to use a double-seal. Standard tray-cassettes sealed in MELAfol that the side-seals do not split open.
Multiple wrapping
The pulsed flow method means it is possible to use multiple wrapping.
Maximum loads
Loads should not exceed 3 kg of instruments or 0.5 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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29-S there are 2 types of tray rack:
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(250 mm wide) must be taped and clasped additionally to ensure
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, then the items should if possible be stood
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Operating-manual Euroklav
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.
4.4 Closing the door _____________________________________________________
The door is closed by lightly applying pressure in the direction of the chamber flange and at the same time pressing down the sliding door catch. The display shows the message:
Door
closed
Program
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:
Parameter/Application Program name/Display message Universal program at 134°C, 2 bar, and a
sterilization time of 3.5 min for the sterilization of wrapped items, in particular instruments (no Hollow A), or mixed loads (unwrapped/wrapped)
Universal Program
134°C wrapped
Start-Stop
Program
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29-S
Quick Program at 134°C, 2 bar and a sterilization time of 3.5 min for the sterilization only of unwrapped instruments (no Hollow A, no textiles)
for rapid re-use (drying can be interrupted manually) Gentle Program at 121°C, 1 bar , sterilization time
15 min for the sterilization of all types of wrapped items (except Hollow A), in particular large amounts of textiles or thermolabile materials (plastic, rubber), or mixed loads (wrapped/unwrapped)
Bowie & Dick Test Program at 134°C, 2 bar and a sterilization time of 3.5 min. to check the operation of the autoclave (Steam penetration of special indicators)
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). MELAsteam Cleaning at 136°C, 2.3 bar, and a maximum cleaning time of 60 min., for the steam cleaning of instruments that have already been
disinfected. CAUTION: Use only together with a permanently installed MELAsteam system is disabled.
See the Operator’s Manual for MELAsteam
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Pistol (otherwise the
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.
Quick Program
134°C unwrapped
Gentle Program
121°C wrapped
Bowie & Dick Test
134°C 2.2bar 3.5min‘
Prion-program
134°C wrapped 20‘
MELAsteam-Cleaning
2.3bar 60‘
Program
Program
Program
Program
Program
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Parameter/Application Program name/Display message
Basic display (no program selected)
Program
15:31:33
0.02bar 22°C
4.6 Program start________________________________________________________
Press the "Start-Stop" button 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.
Start
Program
At the start of the quick program there will be an additional message "Warning: Only unwrapped instruments". This message must be acknowledged by pressing "Start" again.
4.7 Program progress ____________________________________________________
After starting the program, it will then progress automatically. The display shows the current program status as follows:
Program status
1. Phase 1 and following Depending on the program chosen and the temperature of the chamber at the start of the program, a number of cycles of steam inflow and outflow follow to ensure adequate penetration of super-heated steam into the items being sterilized.
2. 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
Display message
1.Fractionation
0.69 bar 115°C
Heat up
1.80 bar 117°C
Start-Stop
Program
Program
Start-Stop
Start-Stop
3. 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.
4. Pressure release After completion of the sterilization time, the pressure is released and the steam generator emptied. Pressure and temperature fall.
5. 1st drying phase (Flow drying) After pressure release the drying phase begins. Throughout the drying phases the program can be ended without an error report, since the sterilization itself has been completed. However, with the exception of the "Quick Program" you should normally wait until the drying is completed..
Program
Start-Stop
Sterilization
2.18 bar 135°C
Program
Start-Stop
Sterilization
Still 2 min 12 sec
Program
Start-Stop
Pressure release
0.85 bar 96°C
Program
Start-Stop
Flow drying
1' 0.9bar 85°C
Program
Start-Stop
Immediate removal
Press 'Stop'
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29-S
Program status
7. Program end After ventilation of the chamber the program is completed. If a printer is attached and print-out "yes" is selected, the record will be printed-out immediately.
After the door has automatically unlocked the door can be opened to remove the sterilized objects.
Display message
Operating-manual Euroklav
Program
Start-Stop
Quick Program
Succesfully run
Program
Start-Stop
Please wait
Door unlocking
Program
Start-Stop
Open door
please
Page 13
4.8 Print-out record ______________________________________________________
The print-out record contains the following information:
-----------------------------------------­ MELAG Euroklav 29-S
------------------------------------------
Program : Universal-program 134°C wrapped Date : 03.04.2000 Time of day : 08:21:43 (Start) Batch number: 3
------------------------------------------
Preheating 107.5 °C Conductivity 16 S/cm
Program step Press. Temp. Time bar °C min
Start 0.01 58.7 00:00
1. Fractionation Steam entry 1.00 81.0 01:10 Press. release 0.19 84.0 01:29
2.Fractionation Steam entry 1.01 106.2 02:31 Press. release 0.19 94.8 03:01
3.Fractionation Steam entry 1.00 114.8 04:07 Press. release 0.19 99.6 04:48
4.Fractionation Steam entry 1.01 118.1 05:55 Press. release 0.19 99.5 06:42
5.Fractionation Steam entry 1.00 118.7 07:48 Press. release 0.20 98.2 08:40
6.Fractionation Steam entry 1.00 118.2 09:49 Press. release 0.19 97.1 10:45 Heat up 2.04 132.5 13:15 Steriliz.begin 2.04 132.5 13:15 Steriliz.end 2.17 135.6 16:45 Pressure release 0.50 113.2 17:52 Current-drying Drying begin 0.50 113.2 17:52 Drying current 0.40 100.2 18:23 Drying pumping 1.12 102.7 18:50 Drying end 1.11 109.3 37:44 End 0.54 106.7 37:54
------------------------------------------
Temperature : 135.5 +0.2 /-0.4 °C Pressure : 2.17 +0.01/-0.01 bar Sterilizate time: 3 min 30 s Time of day : 08:59:37 (End)
========================================== 84 0000815 3.16 1.13
PROGRAM PROPERLY EXECUTED!
Program Date Time of start Running load number for the day Pre-heating temperature Conductivity of purified feed water
Program phases with the values for steam pressure and temperature, and time (relative to program start)
Final report
Mean sterilization temperature/ deviations Mean sterilization pressure / deviations
Duration of sterilization Time at end of program
Info-line with total number of loads, Works number and software version.
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Operating-manual Euroklav
4.9 Removing the sterilized items __________________________________________
After opening the door the sterilized items can be removed. Be careful when removing the sterilized items! Touching the metal surfaces can lead to burns. Always use the appropriate aids to lift the trays (MELAG-tray lever, standard tray-lifter) or wear suitable hand protection.
4.10 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 re­wrapped. It is important for sterile storage that the items have been properly dried. The Euroklav good drying if the program has not been interrupted before its completion and the autoclave has been properly loaded (see Section 4.2). 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, DIN 58953 Part 7 gives the following guidelines for the maximum storage periods for sterilized objects: in basic wrapping (e.g. transparent sterilization foil) up to 6 weeks; in double-wrapping up to 6 months.
®
29-S provides very
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29-S
4.11 Sterilization frequency / pauses ________________________________________
After completing or terminating the drying phase, the autoclave can be reloaded and started immediately. However, continuous operation can lead to increased development of water vapour from the water storage tank. This is not harmful for the Euroklav cm) and it is not fully enclosed (e.g. in a cupboard). In order to reduce formation of water vapour it is advisable to have a 20 min pause between loads. The Euroklav around it.
®
29-S should never be installed in an enclosed position, and should always have sufficient space
®
29-S provided there is sufficient space around it for ventilation (10-20
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