Melag Vacuklav 31-B Autoclave - User Manual
Melag Vacuklav 31-B Autoclave - User Manual
Melag Vacuklav 31-B Autoclave - User Manual
for the
Autoclave
Vacuklav 31 B
Dear Doctor:
Thank you very much for the trust which you have shown by purchasing this autoclave.
As all other MELAG products, this autoclave was manufactured and tested according to
strict quality criteria. Before placing this unit into operation, please carefully read this Op-
erating Manual. The long-term functional effectiveness and the preservation of the value
of your autoclave will primarily depend on careful preparation of instruments before ster-
ilization, and on proper care of the unit.
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Operating Manual for the Vacuklav®31-B
Seite 3
Page 4
1 Description of the unit 1.2 Technical data _______________________________________________________
1.1 Views of the unit __________________________________________________________ 1.2.1 Primary technical data _____________________________________________________________
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Operating Manual for the Vacuklav®31-B
A A
Example 1 Example 2
A A
Example 3 Example 4
B B
Fig. 2. Installation examples for Vacuklav (A) with double-chamber trap (B)*1
*1 Alternative: a separate drain with stench trap, instead of the double-chamber trap.
Example 1 Example 2
Vacuklav31-B rear view Vacuklav31-B rear view
Standard version = version as supplied MELAdem37 (optional), external water supply,
(with internal supply of water) with manual draining of the waste-water tank
Leak detector with shutoffvalve and sensor
(optional)
Example 3 Example 4
Vacuklav31-B rear view Vacuklav31-B rear view
MELAdem37 (optional), external water supply, MELAdem47 (optional), with drain of waste water
with manual draining of the waste-water tank automatically into a double-chamber trap
MELAjet (optional) Leak detector with shutoff valve and sensor
Leak detector with shutoff valve and sensor (optional)
(optional)
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1.4 Control panel ___________________________________________________________
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Operating Manual for the Vacuklav®31-B
1.5.7 Pre-heating___________________________________________________________________________
Activating the pre-heating function warms up the cold autoclave chamber before sterilization, or maintains the
temperature between sterilization cycles. This shortens the duration of cycles and considerably reduces the
formation of condensation, thus optimising drying results.
1.5.8 Documentation of results _______________________________________________________________
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®42 printer can be connected 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 archiving of all results, and for printing
out these results as needed.
2 Installation
For the steps required to prepare for and carry out the setting up and installation of this autoclave, see the separate
instructions contained in “Setting up the Vacuklav®31-B”.
2.1 Requirements for installation ______________________________________________
The autoclave should be set up in a dry place which is protected against dust. The base should be stable and
capable of supporting the weight of the appliance (unloaded weight = 43 kg). The space required by the autoclave
can be seen from the external dimensions (see Section 1.2.1 here). A minimum additional space of 10 cm should
be allowed on both sides 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.
This autoclave operates with a blower for the cooling system, on the rear side of the unit. If there is a restriction of
the escape of heat above the unit, this can impair the functioning and shorten the service life of the autoclave.
IMPORTANT: We therefore urgently advise our users not to install the autoclave in an area where there is
not sufficient circulation of air.
If the user decides 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 drain (standard length of
outflow pipe = 2 m, with 16 mm diameter). 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 dual-chamber storage tank,
with freshwater and wastewater chambers. Alternatively, the Vacuklav®31-B can also be connected to an external
water purifier – the MELAdem®47 or MELAdem®37 (or an equivalent water purification system). However, please
note that this will require additional space.
2.2 Transport ribbons _______________________________________________________
Lift the autoclave out of the packaging by using the transport straps. The straps themselves are each removed by
unscrewing the two retaining screws, which must then be screwed firmly back in place without washers.
2.3 Levelling ______________________________________________________________
In order to operate properly, and to allow unimpeded return flow of condensate into the steam generator, the auto-
clave must be installed so that it definitely slopes toward the rear. First install the autoclave in a horizontal (level)
position, and check that this position is in fact horizontal with a spirit level at the chamber flange. Then extend the
front feet to lift up the front side of the autoclave, by screwing the feet out by at least three (3) turns.
2.4 Mains power supply _____________________________________________________
The electric cable of the appliance must be plugged into a mains socket rated at 230 V / 50 Hz. The power rating of
the autoclave is 2400 W. In order to avoid overloading the building electricity supply, we recommend using a
separate electrical circuit fitted with a 16 A fuse and optionally protected with a type RCCB (residual current circuit
breaker) with a tripping current of 30 mA.
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2.5 Outlet connection for one-way water _______________________________________
The connection for the one-way water outlet at the back of the unit (3) must be hooked up to the drainage system
of the building by means of the outlet pipe supplied (transparent pipe). It is important that the pipe should have a
steady downward gradient, without twists and kinks. The outlet must be connected to an existing sink drain, or
to a separate NW40 drain pipe with use of the wall-mounted drain (MELAG article no. 37410).
2.6 Internal water supply with demineralized / distilled water ______________________
If the user decides for internal supply of the autoclave with demineralized / distilled water, this water is taken from
the right chamber of the built-in water storage tank. To install the internal system for supply of demineralized /
distilled water, connect the hose at the demineralized / distilled water connection of the supply tank to the swivell
threaded connection at the supply point for demineralized / distilled water on the rear side of the autoclave. For this
variation of water supply, the autoclave is delivered ready for installation. To fill the feed water tank, remove the
cover of the tank and fill the right chamber with demineralized / distilled water up to the maximum mark.
2.7 Connection of a water treatment system ____________________________________
The autoclave can be directly connected to a water treatment system for direct supply with demineralized / distilled
water. Instead of being connected to the water storage tank (as in Section 2.6), the demineralized / distilled water
connection is hooked up directly to the water treatment system. The reverse-osmosis system MELAdem®47 and
the ion-exchanger MELAdem®37 are designed to optimally satisfy the requirements of the Vacuklav®31-B. Please
consult the operating manuals of these reverse-osmosis systems for detailed instructions on installation and
placing into operation. If you decide to use water treatment systems made by other manufacturers, be sure that
they deliver water with sufficient quality and quantity. Please get in touch with the company MELAG before
connecting such systems made by other manufacturers. In addition, a water stop valve (MELAG article no. 01056)
should be installed upstream of such water treatment systems, in order to satisfy insurance requirements.
2.8 Emptying the water storage tank __________________________________________
It is easy to completely empty the water storage tank of this autoclave. This is required, for example, to clean or
repair the autoclave, or to place it out of operation. To drain the tank, pull the drain hoses out of the front panel at
the plug (see Fig. 1: drain side [21], and tank side, with demineralized water [22]). Pull out the plugs, and allow the
water to drain into a separate container.
3 Placing the autoclave into operation
3.1 Printer connection and initialisation (optional) _______________________________
3.1.1 Connection of the MELAprint®42 _________________________________________________________
The accessory printer MELAprint®42 is designed for connection to the autoclave Vacuklav®31-B. This is an optional
item which is not supplied with the normal scope of delivery for the autoclave. Follow the instructions in Section
6.3.1.1.1 of this manual to connect the printer to the autoclave.
3.1.2 Initialisation of the printer / setting for immediate printout____________________________________
Follow the instructions in Section 6.3.1.1.2 of this manual to initialise the external printer after it has been
connected. This initialisation will log the printer on to the computer control system in the autoclave. Follow the
instructions in Section 6.3.2 of this manual to set the immediate-printout option to "Yes". This means that the
system will automatically print out a report when the system program has come to an end.
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Operating Manual for the Vacuklav®31-B
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Operator action: Shown on the display:
7. After the measuring time has
Program Start-Stop
run out (10 min), the cham-
ber is vented, and ... Ventilate
–0.56 bar 25 °C
... then the leak rate is given
(with connected printer and Program Start-Stop
setting for immediate print-
out = “Yes”, a record will
now be printed out. After the
message “Please wait –
Leak rate = 0.2 mbar
door unlocking”, the follow-
ing request will appear:
Program Start-Stop
Open door
please
8. Open the door.
Program Start-Stop
Vacuum test
If the leak rate determined is greater than the maximum permissible value, the following will appear in the display
and on the printed log: “Test not successful”. In such a case, follow the instructions given in this manual under
Section 7.3.
3.3 Trial run _______________________________________________________________
To continue the functional check of the autoclave, carry out the trial run by loading the autoclave with a typical load
for your daily work, and then run the program “Universal program, 134°C, wrapped”. Load the autoclave and use
the “Program” button to select this program. Then press the button “Start – Stop”. If the program runs correctly
(also see Section 4.7 here), the following message will appear at the end of the program:
Program Start-Stop
Universal program
run successfully
This display will also show the maximum values achieved for pressure and temperature. If a printer is connected,
and with setting for immediate printout = “Yes”, a record will now be printed out.
3.4 Installation log – sent to MELAG ___________________________________________
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 for the Vacuklav®31-B
* Danger: Be careful when opening the door of the autoclave, especially if you are
interrupting a drying cycle. Small amounts of residual steam can escape through the door
and can burn operating personnel.
* Warning: After opening the autoclave door, do not touch exposed hot metal parts.
Warning: These parts can burn operating personnel. Be sure to use a MELAG or standard
tray handle to remove still-hot trays from the autoclave. Be sure to use suitable hand
protection (for example, potholders or gloves) when removing other sterilizing containers.
* We recommend the installation of a leak monitor in the water supply line (see Section 2,
Installation, for instructions).
* If you wish to connect to this autoclave water-treatment systems which are made by other
equipment manufacturers, get in touch with the MELAG company before you install this
equipment.
* Important: Empty the water supply tank before moving the autoclave. If the autoclave has
water inside, do not tip it.
* This device may be repaired only by the company MELAG or by persons authorised by
MELAG (specialist personnel or customer-care staff). These persons must use original
spare parts and must observe the instructions for service published by MELAG.
* Danger: Do not open the enclosure to this device before disconnecting the electrical power
plug from its outlet.
* This autoclave will properly sterilize only if the operating personnel observe the instructions
in this Operating Manual – especially the instructions for loading the autoclave in
accordance with the program required.
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4 For each sterilization cycle
4.1 Water and power _______________________________________________________
4.1.1 Demineralized / distilled water__________________________________________________________
This autoclave automatically checks to make sure that there is enough demineralized / distilled water, and it checks
that the quality of the demineralized / distilled water is sufficient for starting a program. In order to start a program
without delay, to avoid error messages, and to prevent a program from stopping before it is finished (see Sections
7.3 and 7.4), please make sure to carry out the following:
1. Before starting the first sterilization cycle of a day, check to make sure that there is enough water in the right
side of the dual-chamber water supply tank (this applies if you are using the system’s own internal supply: i.e., if
you are not using a connected water-treatment system). If there is not enough water in the tank, fill with water of
sufficient quality (see Section 8.3.2 of this manual).
2. If you use a direct water supply from the MELAdem®47 water-treatment system, make sure that the water feed
to the autoclave is open in time. If the pressure tank is empty, this feed must be opened at least one hour before
starting a program. This step is not necessary if the water supply remains open continuously .
4.1.2 Power supply________________________________________________________________________
Switch on the power switch at the bottom right of the front of the autoclave. The message “Please wait – Door
unlocking” will appear in the display. After approx. 15 s, the device will then be in its initial state.
Program Start-Stop
Time of day (h:min:s)
14:27:12
Chamber pressure (bar) 0.02bar 25°C
Temperature (steam) (°C)
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Operating Manual for the Vacuklav®31-B
Instruments new from the factory:
Be sure also to follow the above-described pre-cleaning procedure even for instruments new from the factory.
Often there are small amounts of oil, grease, and impurities still on new instruments, from their production.
Important: It is absolutely necessary to carefully follow the instructions for preparation and re-sterilization
procedures which are provided by manufacturers of instruments.
4.3 Loading the autoclave ____________________________________________________
The correct loading of the autoclave is essentially important in guaranteeing the sterilization effectiveness and the
proper drying of the items being sterilized. Be sure to observe the following basic instructions in loading the
autoclave:
Tray mounts:
There are 2 different tray mounts for the Vacuklav®31-B:
1. Tray mount “B” (MELAG art.-no. 40234) for loading of either a maximum of 4 trays, or 4 standard tray cassettes
2. Tray mount “C” (MELAG art.-no. 40232) for loading of either a maximum of 6 trays, or 3 standard tray
cassettes.
Both of these tray mounts are also designed to support the following MELAG sterilization containers:
Types 15K,M,G; Type 17K,R; Type 23R, Type 28M,G.
In normal cases the autoclave should always be operated with a tray mount, since this ensures optimal steam
penetration and drying. In exceptional cases, it may be possible to remove the tray mount and place the suitable
containers directly into the sterilization chamber (for example, with use of sterilization containers of other
manufacturers). But please check with your specialist dealer or with MELAG before attempting this solution.
For sterilization of instruments sealed in see-through sterilization packaging, we recommend the use of the MELAG
Package Stand (MELAG article no. 22410). The Package Support considerably improves the results of the drying
process for instruments wrapped in this way.
Trays:
Trays used for the loading of sterilized items must be perforated, in order to allow the condensate to run out.
MELAG trays fulfil this requirement. We cannot advise the use of non-perforated trays or bowls (e.g., unperforated
standard-tray supports), since they do not allow proper trying.
Closed sterilization containers:
Closed sterilization containers must be perforated on at least one side (preferably the bottom), or they must have
valves, in order to allow the steam to properly penetrate and the condensate to flow out. All MELAG sterilization
containers satisfy this requirement, with perforations on two sides and with a sterile filter cloth insert. We cannot
recommend sterilization with sterilization containers with holes only on the top, since they do not allow proper
drying.
See-through sterilization packaging:
If you use see-through sterilization packaging (for example, MELAfol®), these should be placed vertically on the
tray for sterilization. We recommend the use of MELAG Foil Holders (MELAG article no. 22410).
Important: Do not stack the see-through sterilization packages horizontally on top of each other. If the sealing
seam of the package breaks during sterilization, please use a longer sealing pulse on the MELAG MELASEAL
Package Sealing Device, or seal with a double seam.
If standard tray cassettes are sealed in MELAfol® (250 mm wide), clamps or tape must be used to reinforce the
side seam and to prevent it from breaking open. In addition, be sure to press excess air out of the package before
sealing it.
Multiple packaging:
Air removal by sub-atmospheric pulsing allows multiple-wrapping.
Loading limits:
Be careful not to exceed the prescribed maximum loading amounts: 5kg of instruments or 1.8kg of textiles.
Mixed loads of textiles and instruments:
If you are sterilizing textiles and instruments at the same time, place the textiles above the instruments and do not
allow the textiles to come into direct contact with the instruments. Do not sterilize textiles and instruments in the
same sterilization container. Important: Do not by any means allow the textiles to come into direct contact with the
wall of the sterilization chamber. Please observe the following instructions for different types of packaging in one
sterilization cycle:
Place the see-through sterilization packaging and paper packing on the top (but if you are using a combination with
textiles: then arrange these packages on the bottom)
Sterilization of liquids:
Danger: The Vacuklav®31-B is not suitable for the sterilization of liquids.
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4.4 Closing the door ________________________________________________________
Close the door by slightly pressing it shut in the direction of the sterilization chamber flange, and at the same time
press down the sliding handle until it will go no farther. The following message will appear on the display:
Program Start-Stop
Door
closed
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Operating Manual for the Vacuklav®31-B
4.6 Start of program_________________________________________________________
Start the selected program by pressing the button “Start – Stop”. When you press this button, the autoclave will
automatically begin to check the quality and quantity of the available demineralized / distilled water, and will run a
conductivity test.
Program Start-Stop
Start
When you start the “Quick program”, the display will also show the warning message: “Warning: only unwrapped
instruments”. When you start the disinfection program, the display will show the warning: “Warning: Not steriliza-
tion”. When you see these messages, you must acknowledge them by pressing the button “Start” again.
4.7 Program sequence_______________________________________________________
After you start the program, its sequence will begin to run fully automatically. The display will continuously show the
status of the running program as follows:
3. Heating-up phase
The heating-up phase follows pulsing. Con- Program Start-Stop
tinued injection of steam into the chamber Heat up
increases the pressure and temperature, in
accordance with the saturated-steam curve, 1.80 bar 117°C
until the programmed parameters are achieved.
4. Sterilization phase
When pressure and temperature are in accor- Program Start-Stop
dance with the saturated-steam curve, and Sterilization
when the programmed required values are
reached, the actual sterilization time begins to 2.18 bar 135°C
run. The display flashes between showing the
pressure / temperature, and showing the time
remaining in the sterilization phase. Program Start-Stop
Sterilization
still: 2 min, 12s
5. Pressure release
After the sterilization phase has come to an Program Start-Stop
end, pressure release will follow, with simulta- Pressure release
neous emptying of the steam generator. Pres-
sure and temperature fall. 0.85 bar 96°C
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Program status: Shown on the display:
6. Drying phase
After the pressure has been released, the Program Start-Stop
drying phase begins. After the drying phase Vacuum-drying
begins, it is possible to interrupt the program
without causing an error message. This is sin. 1' –0.9bar
because the actual sterilization phase is com-
plete. You should wait until the drying has
come to an end, however (unless you are Program Start-Stop
using the “Fast program”).
immediate removal:
press "STOP"
7. Ventilation
At the end of the drying period, the sterilization Program Start-Stop
chamber is vented in a pressure-compensation Ventilate
process, until the pressure returns to normal
atmospheric level. –0.12 bar 60°C
8. End of program
Program Start-Stop
When the venting of the sterilization chamber
is complete, the program cycle is finished. Quick-program
If a printer is connected to the autoclave, and if run successfully
the immediate-printout option is set to “Yes”, a
record of the sterilization cycle will be printed
out. Program Start-Stop
Please wait
door unlocking
Program Start-Stop
When the autoclave has automatically un- Open door
locked the door, you can open the door to
remove the sterilized items. please
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Operating Manual for the Vacuklav®31-B
------------------------------------------
MELAG Vacuklav 31-B Program which has started
------------------------------------------
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sterilization it can occur that condensation residue remains on the sterilized items or on their package. The heat
from the still-hot sterilized items will evaporate this condensate after completion of sterilization. DIN 58953, Part 7,
Section 7, contains the following on moisture residue on paper wraps or see-through sterilization paper after
sterilization: “Small amounts of water on the outside of the packages are harmless if they have dried away within
30 minutes after taking them out of a steam sterilizer.”
After they have cooled down, provide sterile storage for wrapped sterilized items where they are not subjected to
dust (for example, in an instrument cabinet). Under conditions of dust-protected storage, DIN 58953, Part 7,
provides a rule of thumb for the maximum shelf life of sterilized items: six (6) weeks for sterilized items in single
wrapping (e.g., see-through sterilization packages), and six (6) months for sterilized items in double sterilization
packages.
4.10 Sterilization frequency / interval periods_____________________________________
After the drying phase has run out, or after it is interrupted by the user, the autoclave can be immediately loaded
with new items and started again at once. It is not necessary to wait before starting the next cycle.
4.11 Manual abort of the program ______________________________________________
4.11.1 Aborting during the sterilization phases___________________________________________________
It is possible to terminate any started program prematurely by pressing the "Start-Stop" button. Caution: If you
abort a program before it reaches the “Drying” step, then the items inside the autoclave must be considered not
sterile.
Warning! When you open the autoclave door, it is possible that dangerous steam can escape from the sterilization
chamber (depending on the operating status just before the door is opened). If you abort a program before it
reaches the “Sterilization” program phase, we recommend that you run the next program without any items in the
sterilization chamber.
Program Start-Stop
Acknowledge
with button "–"
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Operating Manual for the Vacuklav®31-B
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4.12 Response in case of warnings and error messages ________________________
The Vacuklav®31-B has safety features as well as an extensive checking and monitoring system which is
integrated into the computer control. These functions guarantee a maximum of possible reliability for the
sterilization process, and eliminate risks arising from the autoclave for the patient and the autoclave operator.
For example, the system continuously tests a number of autoclave functions (for example, the sensor systems for
pressure and temperature) after the power switch is turned on. The autoclave system also checks to make sure
that further conditions are met for successful program start: For example, that power and water are present in
sufficient quantity and quality. Start of the program is not possible if these conditions are not fulfilled.
After the initial test, and after the program starts, the system will monitor all parameters relevant for sterilization, as
well as additional limit values for the individual program phases. If these limit values are exceeded, the system will
display the respective error messages and will automatically interrupt the program.
In addition to instructions, warnings, and error messages on the display, the printer (if connected) will log out the
type of errors and faults, and the time of their occurrence.
If any of the above-stated messages appear, please read Section 7 of this manual for appropriate reactions. This
section also contains instructions concerning possible operator faults.
4.13 Operational shutdowns ___________________________________________________
If the autoclave is not being used for a certain period of time (for example, overnight), leave its door slightly open
rather than closing it. This will spare the door gasket and will lengthen its service life (e.g., by preventing it from
sticking shut).
In case of longer inactive periods – such as vacations – shut off the supply of water from the water treatment
system.
• Pull out the power plug. Allow the autoclave to cool down.
• Drain both chambers of the water supply tank (see Section 2.8). Or, if you have a direct connection to a water-
treatment system, shut off the supply of demineralized / distilled water from this system.
• Disconnect the hoses on the rear of the autoclave if you are using a water-treatment system (external water
supply).
• If you are transporting the autoclave with its tray racks and trays still inside, protect the surface of the door
window by inserting a layer of foam rubber or other suitable material (e.g., bubble wrap) between the door and
the sterilization chamber.
• Important: To prevent transport damage, be sure to use the original packing of the autoclave. If there
is a danger of frost damage during transport, be sure to follow the steps provided in the special
service instructions.
• To place the autoclave back into service after transport or repair, follow the instructions given in Sections 2
and 3 of this manual.
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Operating Manual for the Vacuklav®31-B
6 Special functions
6.1 Display of water quality (conductivity) / pre-heat temperature of the sterilization
chamber _______________________________________________________________
Be repeatedly pressing the "–" button, you can at any time display the pre-heat temperature of the sterilization
chamber, and the conductivity of the demineralized / distilled water being used. These two displays will flash
alternatively on the screen, as follows:
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external paper-roll mount, insertion of the paper roll, etc.), and on how to operate the printer, please consult the
manual for the printer.
6.3.1.1.2 Initialization of the printer _____________________________________________________________
After you have connected the printer to the autoclave, you must initialise the printer. This means logging it in to the
autoclave computer control system. Please proceed as follows:
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Operating Manual for the Vacuklav®31-B
6.3.1.2 Connection to an external PC __________________________________________________________
6.3.1.2.1 Installation _________________________________________________________________________
You can also use an external PC to output the autoclave log, and to archive data. To install this mode, use a null
modem cable to connect the serial interface of the PC to the printer interface of the autoclave. You must install the
program MELAwin on your PC to allow data transfer and to enable processing of this data. The software manual for
MELAwin provides detailed instructions on all the possibilities you can use.
6.3.1.2.2 Initializing the output on your PC_______________________________________________________
After you have connected the autoclave to your PC, you must set the log output function to "External PC". Follow
the same procedure here as for initialisation of an external printer (see Section 6.3.1.1.2 of this manual). There is
one difference, however: under step no. 5, use the "+" or the "–" button to set the option to "External PC".
6.3.1.3 No printer ___________________________________________________________________________
In order to set the option "No printer", follow the same procedure as described under Section 6.3.1.1.2. There is
one difference, however: under step no. 5, use the "+" or the "–" button to set the option to "No printer".
6.3.2 Immediate printout option: YES or NO ___________________________________________________
If you have connected an external printer to the autoclave, and if you have initialised this printer, you can have the
autoclave automatically log out a printout at the end of each program cycle. To make this setting, first switch on the
main power to the autoclave, and then carry out the following steps:
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6.3.3 Printing out stored cycles at a later time _________________________________________________
If you have connected an external printer to the autoclave, and if you have initialised this printer, you can print out
earlier cycles which you have later selected. To do this, switch on the autoclave at its mains power switch, and
make the following settings:
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Operating Manual for the Vacuklav®31-B
6.3.4 Printing out all stored cycles ___________________________________________________________
If you have connected an external printer to the autoclave, and if you have initialised this printer, you can print out
all stored logs at any point in time. To do this, switch on the autoclave at its mains power switch, and make the
following settings:
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6.3.5 Displaying the contents of the printer memory ____________________________________________
If you have connected an external printer to the autoclave, and if you have initialised this printer, you can look at
the content of the printer memory by carrying out the following steps:
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Operating Manual for the Vacuklav®31-B
6.3.6 Deleting stored cycles from the memory _________________________________________________
You may wish to erase all stored cycles from the memory: for example, to avoid the warning “Printer memory full”.
This is possible only if you have set the immediate-printout option to “No” (see Section 7.3 of this manual). First,
switch on the power to the autoclave, and proceed as follows:
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6.3.7 Test printout ________________________________________________________________________
To check the printer functions and the communication between the printer and the autoclave, print out a test log as
follows:
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Operating Manual for the Vacuklav®31-B
6.4 Setting the date and time of day ______________________________________
You can set the date and time of day as required (for example, for changes between winter and summer time).
Proceed as follows:
Program Start-Stop
Date / Time of day
Second: 13
Program Start-Stop
Date / Time of day
Day: 14
Program Start-Stop
Date / Time of day
Month: 05
Program Start-Stop
Date / Time of day
Year: 00
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Operator action Shown on the display:
7. Press the button "Program" to Program Start-Stop
confirm the newly set value.
The new value will now stop
Date / Time of day
flashing. To set other values,
return to step 4 above and
Minute : 28
follow the same procedure.
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Operating Manual for the Vacuklav®31-B
Operator action Shown on the display:
6. Then press "Start-Stop" again Program Start-Stop
to return to the initial menu
position. 14:27:12
–0.02bar 25°C
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6.7 Changing the setting for supply of demineralized / distilled water _______________
The Vacuklav®31-B can be set to accept demineralized / distilled water from either outside sources (a separate
water-treatment system) or from internal sources (purchased demineralized / distilled water which is poured into the
water supply tank). Proceed as follows to make this setting:
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Operating Manual for the Vacuklav®31-B
Page 35
7.3 Warning messages ______________________________________________________
If you see the following warning messages in the display, check the instructions given below at the right. Take the
corrective action. Then start the program again. If the warning appears again, please notify your specialist dealer.
Acknowledge
with button "–"
• The minimum or maximum pressure value for ventilation
WARNING! drying has been exceeded. This warning will appear at the
end of the program. It will also appear in the printed log in
the last line:
sterile filter − Corrective action: The sterile filter is defective.
Replace Exchange the sterile filter (MELAG article no.: 20160)
Acknowledge
with button "–"
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Operating Manual for the Vacuklav®31-B
Warning message Cause of trouble / Corrective action
• Communication with the printer via the serial interface is
Printer is interrupted. This warning will appear when the operator
Not ready attempts to print. This warning will appear for 20 s and then
will disappear. If the communication is restored during this
20 s, the data will be printed out. Corrective action:
• It is possible that the autoclave is being operated without
a printer, but that the printer is installed. In this case, fol-
low Section 6.3.1.3 to set the option "No printer" in the
menu "File transmission".
• Check to make sure that the data cable is correctly con-
nected to the autoclave and to the printer.
• Check to make sure that there is power supply to the
printer. If not, restore power. If power is provided, the
MELAprint42 LED display will show a red "P".
• If the printer is offline, set it to online. To set the MELA-
print42 online, press the button "SEL". The green LED
"SEL" will then light up when it is online.
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7.4 Error messages ______________________________________________________
Error messages generally occur with the display message "Error", followed by the error number and a description
of the error.
Error messages can appear before a program is started: i.e., as soon as the power switch is placed on, or some
time after the power is switched on. Or, they can occur after program start, while the program is running. If errors
occur while the program is running, the system will always issue an error message, and it will abort the program.
Depending on the chamber pressure at the time that the error appears, the system may stop the program immedi-
ately and may automatically release the pressure in the chamber. Or, it may stop the program together with ventila-
tion of the chamber. During abort of the program, the display will alternate between the error message and the
program phase ("Pressure release" or "Ventilation"). After the program has been stopped, the display will alternate
between the error message and the message "Acknowledge with button '–'" and "Stop / End". When you press
button "–" this will delete the error message (unless the cause of the error remains, in which case the error mes-
sage will also remain). The door of the autoclave will remain locked until you have acknowledged the error mes-
sage.
If a program is aborted, the items loaded in the autoclave must be considered non-sterile or not disinfected. The
sterilization or the disinfection program must be repeated. In such cases, we recommend that the user remove all
items from the chamber after such an abort, and to run one sterilization cycle without a load. This is because the
drying phase may not proceed properly after the first start.
If an external printer is connected, and if you have set the immediate-printout option for the printer to "Yes", the
system will automatically print out a log at the end of the program abort. This will take place not only for non-cyclic
errors (i.e., a program has not started), but also for cyclic errors (i.e., during a program). The printed log will show
the complete error designation. If the program is aborted before the end of the sterilization phase, the printout will
also show the message "Load not sterile".
The following tables show the error messages, their causes, and the corrective action:
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Operating Manual for the Vacuklav®31-B
Error message Cause of trouble / Corrective action
• The monitoring time was exceeded for venting the sterilization
Malfunction 6: chamber. Corrective action:
Ventilation − The sterile filter may be dirty. If it is, there will be a warning
to this effect before this error message (see Section 7.3 of
this manual).
− Change the filter.
• The maximum limit has been exceeded for the difference
Malfunction 8: between the program run time and the internal computer clock.
Time base Corrective action:
If this error repeatedly occurs, please notify your specialist dealer.
• The door contact has opened during a program. Corrective
Malfunction 9: action:
Door open − Press down the sliding handle until it will go no farther. The
following display will appear: "Door closed".
If this error repeatedly occurs, please notify your specialist dealer.
• The capillary-tube controller "Level control" is open when a
Malfunction 10: program has started (this error message will appear
Steamgen. too hot immediately after the start of the program). Or, during a
program run (until the end of the sterilization phase) the
monitoring time is exceeded until the capillary-tube controller
switches back (it will switch back upon additional feed of
demineralized / distilled water). Corrective action:
− This error message can appear if a program has been
aborted and if the user tries to restart immediately. If so,
wait for 2 minutes and start again.
If this error repeatedly occurs, please notify your specialist dealer.
• The maximum permissible time for locking the door has been
Malfunction 12 exceeded. Corrective action:
Door locking − Check to make sure that the locking pin moves easily.
If this error repeatedly occurs, please notify your specialist dealer.
• The float switch for the supply of demineralized / distilled water
Malfunction 14: does not shut during program run. Corrective action:
No feedwater − See the error message "Warning: Water supply"
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Error message Cause of trouble / Corrective action
• Data inconsistency or data loss has occurred in the data
Malfunction 29: memory. This can be the result of electrical malfunctions (e.g.,
Battery RAM serious mains fluctuations), or of too low battery voltage. When
you acknowledge this malfunction, this will automatically set
the time of day to 00:00, and will set the cycle counter to the
value from the EEPROM. All stored cycles in the memory will
be deleted at the same time. Corrective action:
− After you acknowledge the error message, set the time of
data and date again (see Section 6.4), and restart.
• During the program “Vacuum test”, the maximum permissible
Malfunction 31: pressure was exceeded after the evacuation pressure was
System leak reached (very large leak).
Corrective action:
− Repeat "Vacuum test". If this error message appears again,
please notify your specialist dealer.
• After a program has started, the operational voltage failed. This
Malfunction 32: error message appears after the voltage has returned.
Power failure Corrective action:
− Please check the building electrical systems. If you cannot
find the fault there, please notify service personnel.
• The power fails while a started program is in an overpressure
Sterile filter (hyperbaric) phase. The system additionally requests that you
sterilize the sterile filter, since it has become moist and may
sterilize have picked up micro-organisms. Corrective action:
− Remove the sterile filter on the rear of the autoclave.
− Then sterilize the filter in the "Fast program" (there will be
no filter in the autoclave during this cycle).
− After the program is finished, insert the sterilized filter in the
autoclave again.
• The maximum on-time of the steam generator has been
Malfunction 33: exceeded for achieving the controlled pressure. Corrective
Pressure drop action:
If this error repeatedly occurs, please notify your specialist dealer.
• The temperature has fallen below the minimum permissible
Malfunction 34: sterilization temperature. Corrective action:
Sterilization TU − The amount loaded in the sterilization chamber is too great.
Operate the autoclave with a smaller load.
− If this error repeatedly occurs, please notify your specialist
dealer.
• The sterilization temperature is greater than the maximum
Malfunction 35: permissible limit. Corrective action:
If this error repeatedly occurs, please notify your specialist dealer.
Sterilization TO
• The sterilization pressure has fallen below the minimum
Malfunction 36: permissible limit. Corrective action:
− The amount loaded in the sterilization chamber is too great.
Sterilization PU Operate the autoclave with a smaller load.
If this error repeatedly occurs, please notify your specialist dealer.
• The sterilization pressure has exceeded the maximum
Malfunction 37: permissible limit. Corrective action:
If this error repeatedly occurs, please notify your specialist dealer.
Sterilization PO
• The difference between the measured and theoretical
Malfunction 38: temperature has exceeded the maximum limit. Corrective
action:
Sterilization TD If this error repeatedly occurs, please notify your specialist dealer.
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Operating Manual for the Vacuklav®31-B
Page 41
8.3 Regular care of the Vacuklav®31-B _________________________________________
8.3.1 Cleaning _____________________________________________________________________________
At least once a week perform a cleanliness inspection of the tray rack, the sterilization chamber, the sealing surface
for the door gasket, and the round plate around the door of the sterilization chamber. Check for dirt and for
deposits. Clean dirty spots from the sterilization chamber with a non-ravelling cloth (i.e., which does not shed lint)
which is moistened with methylated alcohol. Before cleaning the sterilization chamber, remove the trays and the
tray rack by lifting them out through the front of the chamber. If there are stubborn spots or stains on the
sterilization chamber, use a non-ravelling cloth moistened in small amounts of a gentle cleaning agent which is
especially designed for stainless steel and which has a pH of 5 ... 8. We recommend the German product Sidol®.
Warning: Be careful that none of this cleaning agent enters the piping which leads off from the sterilization
chamber. Important: The cleaning agent used may not contain chlorine and may not be alkaline. Do not use
metal pot cleaners (such as steel wool), and do not use wire brushes. Once a week inspect the door gasket for
damage and soiling. Remove any dirty spots with normally commercially available, gentle cleaning agents which
have a pH of 5 ... 8 and which do not contain vinegar. Or, use methylated alcohol. If required for cleaning, remove
the door gasket from the plate around the door of the sterilization chamber.
The locking bolts of the door lock (right side of door), as well as the hinges of the door (left side) must be kept
constantly lubricated. This is required to allow ease of shutting and locking the door, and to prevent premature
wear. As required, use silicone grease as a lubricant. You can use normally commercially available, gentle liquid
cleaning agents to clean the outer part of the autoclave enclosure. If water for your autoclave is supplied and
disposed of directly through the built-in water storage tanks, check these tanks for cleanliness each time you fill the
right tank with demineralized / distilled water. Before filling, clean the tanks out if necessary by flushing out with
fresh demineralized / distilled water. Empty the water drain tank on the left side at least every two weeks and clean
it out with clear tap water. In case the drain tank is soiled with stubborn or oily matter, use a suitable synthetic
brush, washing-up liquid (kitchen detergent), and warm tap water to clean it. Then rinse out with demineralized /
distilled water. If the right chamber of the water storage tank is soiled from long service in the circulatory-flow mode
of water supply, then also use warm water and washing-up liquid and a suitable synthetic brush to clean it. After
cleaning, likewise rinse out with demineralized / distilled water.
8.3.2 Use of demineralized / distilled water __________________________________________________
Quality criteria for the demineralized / distilled water used
The following is required for steam sterilization: use of steam-distilled water, or fully demineralized water.
The autoclave operator must observe the values given in the following two tables as criteria for the water quality.
These characteristics are in accordance with CEN standard DIN EN 285.
Battery water is also suitable for operation of the Vacuklav®31-B, but only if it strictly conforms with the relevant
VDE criteria. These criteria are:
Criteria for water quality n accordance with CEN standard DIN EN 285:
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Operating Manual for the Vacuklav®31-B
Where to get water for the Vacuklav®31-B
Battery water in accordance with VDE 510 is available in all major European drug stores, supermarkets, DIY cen-
tres and wholesale markets. The mark "VDE 510" must, however, be specifically contained on the labels of the
water containers. If the VDE 510 standards are not met by the purchased water, calcium carbonate (lime) deposits
in the steam piping and in the valves can seriously impair the functioning of the autoclave. Aggressive water (i.e.,
pH < 5 or > 7) can also damage the autoclave.
Spotting
The extent of formation of spots on the instruments will depend on the quality of the water used for steam genera-
tion.
8.4 Monitoring the functions of the autoclave ___________________________________
8.4.1 Continuous monitoring of sterilization progress ____________________________________________
The electronic parameter control system of the Vacuklav®31-B continuously and automatically monitors the
sterilization-relevant parameters and compares them with standard process data. In the event that the measured
parameters do not satisfy these standard data, the control system will initiate an error message. When the program
runs without error, an “End” message will additionally be shown. In addition, the log printout will output a verification
message.
The user of the autoclave is able to continuously monitor the progress of the program by consulting the values
shown on the display, or by reading the log printout (if a printer is connected to the autoclave).
8.4.2 Periodical bacteriological monitoring (every 6 months) ______________________________________
The standard DIN 58 946, Part 8, Section 3.2 recommends the following:
“Periodic testing takes place at the installation site at intervals of, for example, every six (6) months. The purpose of
this testing is to confirm that the small sterilizer actually properly sterilizes when the operating instructions are
followed.”
If the user so requests, German hygiene institutes and State Medical Testing Laboratories will mail test spores.
After these spores have been treated in the autoclave, the spores are returned to such institutes for testing and
evaluation, with results on a test form.
8.4.3 Periodic maintenance recommendation ________________________________________________
In order to maintain the value of this device and to minimise the rise of its unexpected failure, the MELAG company
recommends periodic maintenance of the Vacuklav®31-B. The maintenance may be conducted only by especially
trained customer-care technicians, or by technicians from the specialised dealer, in accordance with the
maintenance instructions for this particular autoclave. This periodic maintenance consists of visual and functional
testing in which all functions and safety-relevant components and electrical systems are tested. The display of the
Vacuklav®31-B will call attention to the need for this maintenance after two (2) years of autoclave operation, or after
1000 sterilization cycles, whichever comes earlier.
Please get in touch with your specialist dealer, or with MELAG Customer Care staff.
Page 43
9 Annex
9.1 Instructions on drying ___________________________________________________
The standard programs of the Vacuklav®31-B alone provide very good drying of the sterilized items. The
supplementary functions "Additional drying" and "Automatic pre-heating" effectively manage more difficult drying
tasks: for example, with double wrapping (see Sections 6.2 and 6.5 of this manual). Please read the following
sections for a better understanding of the drying processes and how they can be successfully managed. You will
also see how to guarantee optimum drying results by proper loading.
9.1.1 The drying process in sterilization containers ______________________________________________
In autoclaves steam is produced by heating water. The steam heats the sterilization containers and the instruments
inside by transferring its heat to the sterilized items and to their container. This heat-transfer process produces a
change of state in the steam from vapour to liquid. The steam condenses into water, which collects to some extent
as condensate drops on the instruments and their container.
Steam Steam
Heat
Condensate
Formation of condensate on the sterilization container
The steam likewise heats the items being sterilized in the sterilization container. Condensate precipitates out onto
the sterilized items, and part of it drips onto the bottom of the sterilization container.
Steam
Heat
Condensate
Heat
At the end of the sterilization process, during drying, the entire condensate must evaporate: both from the
sterilization container, as well as from the sterile items themselves. This takes place by transfer of heat to the
condensate from the heat stored in the walls of the sterilization container and in the sterilized items themselves. We
recommend the use of sterilization containers made of aluminium, since the good heat-storage and heat-
conductivity properties of this material accelerate the drying process in the autoclave.
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Operating Manual for the Vacuklav®31-B
Heat
For good drying, it is necessary to transfer the available excess heat to the sterilized items. This process requires
removal of the condensate from the walls of the sterilization container. This is achieved by the special design of the
sterilization containers: the recesses and beading in the bottom the bottom, and in the cover by the raised filter
area so that the condensed water can run off.
9.1.2 Textiles ______________________________________________________________________________
When preparing textiles for the autoclave, it is essential that the folds of the textiles lined up be in parallel, and that
the textiles are lined up vertically: see illustration "B" below. This vertical orientation guarantees that channels form
between the textile layers for the air to stream out and for the steam to stream in. Do not by any means stack the
textiles horizontally ("A"), since this will prevent the steam from penetrating the textile package.
A B
How to load textiles
When loading textiles into sterilization containers, make sure that the textiles will stay in their vertical position and
not fall. Do not, however, squeeze the textiles into the container, since this would prevent air and steam flow
channels from forming. If the textile packet will not remain in its vertical position, we recommend wrapping the
textiles in sterilization paper. Make sure that the textiles have as little contact as possible to the walls and bottom of
the sterilization container. If the textiles are in close contact with the walls and bottom, they will excessively absorb
the condensate which has collected there.
For good drying, it is furthermore important that the textiles be dry before they are placed in the autoclave. The heat
energy stored in the sterilization chamber and in the sterilization container is not sufficient to evaporate the
condensate occurring during sterilization AND any moisture brought into the autoclave by damp textiles.
Page 45
9.1.3 Instruments __________________________________________________________________________
If instruments are to be sterilized which can be taken apart, then they should be taken apart before being placed in
the autoclave. This will improve drying results. Do not use lubricants (instrument oil or instrument milk) on
instruments before placing them into the autoclave, unless this is absolutely necessary for the particular
instruments. Before sterilizing instruments with these lubricating or instrument-care preparations, however, make
sure to consult the manufacturer of these preparations and confirm that these substances are suitable for being
subjected to sterilization. Unsuitable instrument-care preparations include types of oil which repel water or which do
not allow the penetration of steam. With such preparations, not only the drying will be poor: even steam sterilization
itself can fail, since these preparations protect not only the instruments but also the micro-organisms on the
instruments.
9.1.4 Loading the autoclave__________________________________________________________________
Do not sterilize textiles and instruments together in one sterilization container. If at all possible, you should not
sterilize textiles and instruments in different sterilization containers in the same cycle batch. If this cannot be
avoided for economic reasons, then please observe the following rules:
• Instruments and sterilization containers on the bottom
• Textiles always toward the top
• See-through sterilization packages and paper packages toward the top (exception: when together with textiles,
then toward the bottom).
Textiles Textiles
A
Instruments Instruments
Instruments Instruments
B
Textiles Textiles
Loading of an autoclave
9.1.5 Loading of containers with soft sterilization packages _______________________________________
Soft sterilization packages such as paper pouches or see-through sterilization packages can be sterilized in
sterilization containers or in sterilization baskets. To ensure better drying, such soft packages should be lined up
vertically at close intervals. This allows the advantage that the condensate can flow off of the packages easily, and
that the packages will not swell up excessively (which can burst the seams).
right
wrong
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Operating Manual for the Vacuklav®31-B
9.1.6 Stacking of sterilization containers _______________________________________________________
When stacking sterilization containers, make sure that the condensate dripping from these containers cannot wet
the sterile items loaded below. The optimum solution is to stack several sterilization containers of the same size on
top of each other: then the condensate will run down the walls of all the containers.
Page 47
10 Index
Changing the setting for supply of demineralized / Performance features 8
distilled water 34 Placing the autoclave into operation 10
Cleaning 43 Pre-heat temperature 23
Control panel 8 Pre-heating 32
Date and time of day 30 Preparation of instruments 14
Door 13, 16, 38, 39 Preparation of of instruments 42
Drag-in rust 42 Printer 9, 10, 22, 37
Drying 45 Printout of cycle log 19
Emptying the water storage tank 10 Regular care 43
Error messages 22, 38 Safety instructions 13
External printer 24 Selection of the program 16
Faulty operation 35 Space requirements 9
Installation 9 Start of program 17
Installation examples 7 Technical data 6
Installation log 12 Trial run 12
Internal water supply with demineralized / distilled Vacuum test 11
water 10 Views of the unit 6
Levelling 9 Warning messages 36
Loading the autoclave 15 Warnings 22
Mains power supply 9 Water and power 14
Manual abort of the program 20 Water consumption 6
Operating times 6 Water quality 23
Outlet connection for one-way water 10 Water treatment system 10
Output of records 24 Water treatment system 8
PC 25