MELAG Vacuklav 23-B User manual

EN1717
User Manual
for the
Autoclave
Vacuklav23 B
with device software version 3.20 et sqq.
Dear Doctor:
Thank you very much for the trust which you have shown by purchasing this autoclave.
For 55 years now, MELAG — a medium-sized family-owned and -operated business —
has specialised 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 400,000 MELAG units sold throughout the world testify to the ex-
ceptional quality of our products — 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 carefully read this
User Manual. The long-term functional effectiveness and the preservation of the value of
your autoclave will primarily depend on careful preparation of instruments before steriliza-
tion, and on proper care of the unit.
The staff and management of MELAG

2
The functional effectiveness and the preservation of
value of this unit depend on:
1. Proper preparation of the instruments to be sterilized
2. Proper care of the autoclave
3. The use of sufficiently pure demineralized / distilled water
1DESCRIPTION OF THE UNIT ....................................................................................................................4
1.1 Views of the unit...................................................................................................................................4
1.2 Technical data......................................................................................................................................5
1.2.1 Primary technical data...................................................................................................................5
1.2.2 Capacity / weights.........................................................................................................................5
1.2.3 Operating media............................................................................................................................5
1.2.4 Operational parameter..................................................................................................................5
1.2.4.1 Programs / operating times....................................................................................................5
1.2.4.2 Consumption of energy / water *) ...........................................................................................5
1.3 Installation examples............................................................................................................................6
1.4 Control panel........................................................................................................................................7
1.5 Performance features of this autoclave................................................................................................7
1.5.1 Preliminary air removal by sub-atmospheric pulsing....................................................................7
1.5.2 Sterilization categories..................................................................................................................7
1.5.3 Separate steam generation...........................................................................................................7
1.5.4 One-way system / conductivity measurement / automatic re-supply of water..............................7
1.5.5 Electronic parameter control.........................................................................................................7
1.5.6 Vacuum drying..............................................................................................................................7
1.5.7 Pre-heating....................................................................................................................................8
1.5.8 Documentation of results ..............................................................................................................8
2INSTALLATION ..........................................................................................................................................8
2.1 Requirements for installation................................................................................................................8
2.2 Transport ribbons.................................................................................................................................8
2.3 Levelling ...............................................................................................................................................8
2.4 Mains power supply..............................................................................................................................8
2.5 Outlet connection for one-way water....................................................................................................9
2.6 Internal water supply with demineralized / distilled water....................................................................9
2.7 Connection of a water treatment system..............................................................................................9
2.8 Emptying the water storage tank..........................................................................................................9
3PLACING THE AUTOCLAVE INTO OPERATION.....................................................................................9
3.1 Printer connection and initialisation (optional) .....................................................................................9
3.1.1 Connection of the MELAprint®42..................................................................................................9
3.1.2 Initialisation of the printer / setting for immediate printout ............................................................9
3.2 Vacuum test ...................................................................................................................................... 10
3.3 Trial run ............................................................................................................................................. 11
3.4 Installation log – sent to MELAG....................................................................................................... 11
3.5 Safety instructions............................................................................................................................. 12
4FOR EACH STERILIZATION CYCLE ..................................................................................................... 13
4.1 Water and power............................................................................................................................... 13
4.1.1 Demineralized / distilled water................................................................................................... 13
4.1.2 Power supply.............................................................................................................................. 13
4.2 Preparation of instruments................................................................................................................ 13
4.3 Loading the autoclave....................................................................................................................... 14
4.4 Closing the door................................................................................................................................ 15
4.5 Selection of the program................................................................................................................... 15
4.6 Start of program ................................................................................................................................ 16
4.7 Program sequence............................................................................................................................ 16
Printout of cycle log...................................................................................................................................... 18
4.8 Removing the sterilized items ........................................................................................................... 18
4.9 Sterile storage................................................................................................................................... 18
4.10 Sterilization frequency / interval periods ........................................................................................... 19
4.11 Manual abort of the program............................................................................................................. 19
4.11.1 Aborting during the sterilization phases..................................................................................... 19

User Manual for the Vacuklav®23-B
3
4.11.2 Interruption of a drying phase.................................................................................................... 20
4.12 Response in case of warnings and error messages......................................................................... 21
4.13 Operational shutdowns...................................................................................................................... 21
5PLACING THE AUTOCLAVE OUT OF OPERATION / TRANSPORT / PUTTING THE AUTOCLAVE BACK
INTO SERVICE................................................................................................................................................ 21
6SPECIAL FUNCTIONS............................................................................................................................ 22
6.1 Display of water quality (conductivity) / pre-heat temperature of the sterilization chamber............. 22
6.2 Selection for additional drying........................................................................................................... 22
6.3 Logging / documentation of sterilization cycles.................................................................................22
6.3.1 Output of logs............................................................................................................................. 22
6.3.1.1 External printer.................................................................................................................... 22
6.3.1.1.1 Connection of the external printer Melaprint®42......................................................... 22
6.3.1.1.2 Initialization of the printer.............................................................................................. 23
6.3.1.2 Connection to an external PC............................................................................................. 24
6.3.1.2.1 Installation....................................................................................................................... 24
6.3.1.2.2 Initializing the output on your PC ................................................................................. 24
6.3.1.3 No printer............................................................................................................................ 24
6.3.2 Immediate printout option: YES or NO....................................................................................... 24
6.3.3 Printing out stored cycles at a later time.................................................................................... 25
6.3.4 Printing out all stored cycles ...................................................................................................... 26
6.3.5 Displaying the contents of the printer memory .......................................................................... 27
6.3.6 Deleting stored cycles from the memory.................................................................................... 28
6.3.7 Test printout............................................................................................................................... 29
6.4 Setting the date and time of day ....................................................................................................... 30
6.5 Automatic pre-heating....................................................................................................................... 31
6.6 Total-cycle counter............................................................................................................................ 32
6.7 Changing the setting for supply of demineralized / distilled water.................................................... 33
6.8 Program modifications....................................................................................................................... 33
7FAULTY OPERATION / MALFUNCTIONS............................................................................................. 34
7.1 What to do in case of malfunctions................................................................................................... 34
7.2 Malfunctions without an error message ............................................................................................ 34
7.2.1 An empty display window........................................................................................................... 34
7.2.2 The autoclave uses too much demineralized / distilled water ................................................... 34
7.2.3 Poor drying................................................................................................................................. 34
7.3 Warning messages............................................................................................................................ 35
7.4 Error messages................................................................................................................................. 37
8PRESERVING THE VALUE OF THIS DEVICE....................................................................................... 39
8.1 Preparation of instruments................................................................................................................ 39
8.2 Drag-in rust (rust brought into the autoclave).................................................................................... 40
8.3 Regular care of the Vacuklav®23-B................................................................................................... 41
8.3.1 Cleaning..................................................................................................................................... 41
8.3.2 Use of demineralized / distilled water ........................................................................................ 41
8.4 Monitoring the functions of the autoclave.......................................................................................... 42
8.4.1 Continuous monitoring of sterilization progress......................................................................... 42
8.4.2 Periodical bacteriological monitoring (every 6 months)............................................................. 42
8.4.3 Periodic maintenance recommendation..................................................................................... 42
9ANNEX..................................................................................................................................................... 43
9.1 Instructions on drying........................................................................................................................ 43
9.1.1 The drying process in sterilization containers............................................................................ 43
9.1.2 Textiles....................................................................................................................................... 44
9.1.3 Instruments ................................................................................................................................ 45
9.1.4 Loading the autoclave................................................................................................................ 45
9.1.5 Loading of containers with soft sterilization packages............................................................... 45
9.1.6 Stacking of sterilization containers............................................................................................. 46
9.1.7 Removing sterilized items.......................................................................................................... 46
9.1.8 Further improvement of the drying process............................................................................... 46
10 INDEX....................................................................................................................................................... 47

4
1 Description of the unit
1.1 Views of the unit __________________________________________________________
1
6
7
8
10
11
12
13
14
15
16
17
19
18
20 21
Side view
Front view
Rear view
2
3
4
5
9
300
500
590
150 250
80
720
Vacuklav®23-B
1 Water storage tank 11 Power cable
2 Emergency overflow (OUT) 12 Front adjustable feet of the unit
3 One-way drain (OUT) 13 Serial data and printer interface (RS 232)
4 Spring-operated safety valve 14 Fuses for the unit: 2 16 A / FF
5 Connection for demineralized / distilled
water (OUT) 15 Power switch
6 Sterile filter 16 Sliding-lock handle
7 Connection for pressure release for
water storage tank (IN) 17 Hinged door (opens to the left)
8 Cooler 18 Operator’s control and monitoring panel
19 Cover to water tank
20 Drain hose for water tank, drain side (OUT)
9 Connection for demineralized / distilled
water (IN) (quick-fitted threaded
connection for 6 1 hose) 21 Drain hose for water tank, demineralized-water side (OUT)
10 Connection for pressure release (OUT)
Fig. 1 Views of the Vacuklav
®
23-B

User Manual for the Vacuklav®23-B
5
1.2 Technical data ______________________________________________________
1.2.1 Primary technical data _____________________________________________________________
Sterilization chamber ( depth) 25 cm 45 cm
Power ratings 2400 W / 230V AC / 10.4 A / 50 ... 60 Hz
Sterilization pressure / temp. 2 bar / 134°C; 1 bar / 121°C
Disinfection pressure / temp. 0.3 bar / 105°C
Maximum load 5 kg of instruments or 1.8 kg of textiles
Outside dimensions 48.5 cm high 42.5 cm wide 72 cm deep
1.2.2 Capacity / weights _________________________________________________________________
Weight of unit (without load) 48 kg
Volume of chamber 22.6 litre
Maximum loading 5 kg of instruments or 1.8 kg of textiles
Water storage tank (demineralized /
distilled water) Fresh-water side: 5 litres (approx. 7 cycles); drain side: 3 litres
Loading variations Mount “B” for max. 4 norm tray cassettes or 4 MELAG trays
Mount “C” for max. 3 norm tray cassettes or 6 MELAG trays
MELAG sterilization containers: 28M,G, 23R,M,G 15K, M, G,
17R,K,M,G
MELAG Package Holders
1.2.3 Operating media __________________________________________________________________
Power ratings:
Electricity ratings 230 V AC / 10.4 A / 50 ... 60 Hz
Power ratings 2400 W; fuse = 16 A; RCCB (residual current circuit breaker); 30 mA
aqua dem / aqua dest Demineralized / steam-distilled water in accordance with VDE 0510
1.2.4 Operational parameter _____________________________________________________________
1.2.4.1 Programs / operating times _________________________________________________________
Program Operating time (not including drying period)*) Drying
Hot start; load = 0.5 kg Hot start; load = 5 kg
"Quick program" (134°C, 2 bar) 17 min 23 min 10 min
"Universal program" (134°C, 2 bar) 30 min 43 min 15 min
"Gentle program" (121°C, 1 bar) 41 min 58 min (1,8 kg textiles) 20 min
" Prion Program" (134°C, 2bar ) 47 min 60 min 15 min
"Bowie & Dick" (134°C, 2 bar) 33 min 40 min 5 min
"Vacuum Test" — 18 min (empty) --
1.2.4.2 Consumption of energy / water *) ____________________________________________________
Power consumption
"Pre-heating"
One-time heating up to pre-heating
temperature (134°C) approx. 0.12 kWh ( = x €1)
"Stand by" operation per hour approx. 0.2 kWh ( = x €1)
"Program cycle" (including drying) 0.3 kWh (= x €1) for “Quick program” / hot start / light load, up to ...
1.1 kWh ( = x €1) for “Gentle program” / cold start / full load
Consumption of demineralized /
distilled water 350 ml ( = 3.5 Cent2.) for “Quick program”
500 ml ( = 5 Cent 2) for “Universal program”
600 ml ( = 6 Cent 2) for “Gentle program”
*) These values are valid for a constant power supply of 230V
1x = electric energy consumption in kWh x price for one kWh in €/kWh
2Based on following price for one litre of distilled water from the MELAdest®65: ca. 0.10 €

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1.3 Installation examples___________________________________________________
Example 1
Example 3
Example 2
Example 4
B
A
A
A
A
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 EN1717
Vacuklav23-B rear view Vacuklav23-B rear view
Standard version = version as supplied
(with internal supply of water) MELAdem40 (optional), external water supply,
with manual draining of the waste-water tank
Leak detector with shutoffvalve and sensor
(optional)
Example 3 EN1717 Example 4 EN1717
Vacuklav23-B rear view Vacuklav23-B rear view
MELAdem40 (optional), external water supply,
with manual draining of the waste-water tank MELAdem47 (optional), with drain of waste water automatically into a double-chamber trap
MELAjet(optional)
Leak detector with shutoff valve and sensor
(optional)
Leak detector with shutoff valve and sensor
(optional)

User Manual for the Vacuklav®23-B
7
1.4 Control panel ___________________________________________________________
Fig. 3: Vacuklav23-B control panel
1.5 Performance features of this autoclave______________________________________
1.5.1 Preliminary air removal by sub-atmospheric pulsing ________________________________________
Preliminary air removal by sub-atmospheric pulsing repeatedly evacuates the air from the autoclave and alternately
introduces steam between evacuations: providing the required penetration of the sterilized objects with saturated
steam. This ensures fast and effective execution of difficult sterilization tasks: e.g., instruments with narrow bores
and large amounts of textiles. This autoclave also features a special program for the Bowie & Dick Test (a
recognised procedure used in large-scale sterilization to confirm steam penetration.
1.5.2 Sterilization categories _________________________________________________________________
The Vacuklav®23-B features three sterilization programs for temperatures at 134°C: the “Universal Program” (for
wrapped objects), the “Prion Program” (a special Universal Program), the “Fast Program” for unwrapped items, and
the “Gentle Program” (a sterilization program for textiles and rubber articles at 121°C). The user can at any time
perform additional functional checks of the autoclave by running the Bowie & Dick Test for steam penetration, and
the Vacuum Test for leak testing. The additional program "MELAsteam®" is available as an option, and functions at
a temperature of 136°C.
1.5.3 Separate steam generation______________________________________________________________
The powerful steam generator outside the actual sterilization chamber makes it possible to sterilize large loads of
instruments or textiles in a short time. No waiting periods are necessary between the sterilization cycles, and
excess temperatures within the sterilization chamber cannot occur.
1.5.4 One-way system / conductivity measurement / automatic re-supply of water ____________________
The Vacuklav®23-B operates with the tried-and-proven one-way system: this means that all evaporated water and
all impurities contained in this water are removed from the autoclave upon pressure release. For the following
program cycle, new demineralized / distilled water is therefore used. An integrated conductivity measurement
system monitors the quality of the demineralized / distilled water used in steam generation. For heavy use of the
autoclave, we recommend supply of the demineralized / distilled water by connection of a water-treatment system
such as the MELAdem® 47 or MELAdem® 37. If the instruments are carefully prepared, this arrangement prevents
spots on the items sterilized, and avoids fouling of the autoclave.
1.5.5 Electronic parameter control ____________________________________________________________
The microprocessor installed in the Vacuklav®23-B implements electronic parameter control, which continuously
monitors pressure, temperature, and time in the programs. The process evaluation and monitoring system
contained in the program control system compares momentary process parameters with standard process data and
monitors the process with respect to limit temperatures, limit times, and limit pressures. This function detects
malfunctions in the program cycle and guarantees the security of the sterilization / disinfection results.
1.5.6 Vacuum drying________________________________________________________________________
The vacuum drying feature ensures good drying results, even for wrapped items.
Program Start / Stop
Function buttons
For selections, settings, and display of
special functions: printing, date and time of
day, pre-heating, total sterilised loads, water
conductivity, error-report acknowledgement
Program selection button
For selection of the sterilisation programs and
test programs, and for selection/settings of
options (sub-menus) for the special functions
Start / stop button
For starting and stopping of
programs, drying, and for
control fo special functions
2 x 20-character alphanumeric LED
display For display of program status and
parameters, and for operator for basic and
special functions

8
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®23-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®23-B can also be connected to an external
water purifier – the MELAdem®47 or MELAdem®40 (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 five (5) 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.

User Manual for the Vacuklav®23-B
9
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®40 are designed to optimally satisfy the requirements of the Vacuklav®23-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®23-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.

10
3.2 Vacuum test ____________________________________________________________
A vacuum test (leak test) should be conducted under the following conditions to assure proper functioning of the
autoclave:
Once when a new autoclave is set up for the first time
When the autoclave is being put back into service after a long period of inactivity
When the autoclave is moved to a new location
Periodically as part of routine operations.
The vacuum test should be performed on the cold autoclave as follows:
Operator action: Shown on the display:
1. Switch on the autoclave
at the power switch: After
the following message ...
... the display will show the
initial state:
2. Press the “Program” button
several times until the pro-
gram “Vacuum test” ap-
pears.
3. Close the door
4. Press the “Start – Stop”
button
5. The vacuum pressure has
been reached. The equilibra-
tion time begins to run (wait-
ing time until beginning of
measurement).
6. After the waiting time has
run out (5 min), the measur-
ing time will begin (here:
7 min 52 s).
Program Start-Stop
Vacuumtest
Program Start-Stop
Door
closed
Program Start-Stop
Vacuumtest: Start
Press. = 980mbar
Program Start-Stop
Vacuumtest 00:00
Press. = 80mbar
Program Start-Stop
Vacuumtest 07:52
Pressure = 82mbar
Program Start-Stop
Please wait
Door unlocking
Program Start-Stop
14:27:12
0.02bar 25°C

User Manual for the Vacuklav®23-B
11
Operator action: Shown on the display:
7. After the measuring time has
run out (10 min), the cham-
ber is vented, and ...
... then the leak rate is given
(with connected printer and
setting for immediate print-
out = “Yes”, a record will
now be printed out. After the
message “Please wait –
door unlocking”, the follow-
ing request will appear:
8. Open the door.
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:
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.
Program Start-Stop
Vacuum test
Program Start-Stop
Leak rate = 0.2 mbar
Program Start-Stop
Ventilate
–0.56 bar 25 °C
Open door
please
Program Start-Stop
Universal program
run successfully
Program Start-Stop

12
3.5 Safety instructions ______________________________________________________
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.
This device is not suitable for the sterilization of liquids.
According to presently valid regulations published by the Society of German Electrical
Engineers (VDE), this device is not suitable for operation in hazardous areas which are
endangered by the possibility of explosion (for example, in hazardous atmospheres).
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 User Manual – especially the instructions for loading the autoclave in accordance
with the program required.
This appliance is only intended for use outside the patient environment (radius of 1.5 metres
around the treatment location).

User Manual for the Vacuklav®23-B
13
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.
4.2 Preparation of instruments________________________________________________
MELAG — use of non-rusting materials for parts which come into contact with steam
All parts of the Vacuklav®23-B which come into contact with steam are made of non-rusting materials. The
sterilization chamber and the chamber door are of stainless steel, steam lines are Teflon®, and threaded
connections and solenoid valves are brass.
Drag-in rust
The non-rusting parts used in the Vacuklav®23-B ensure that the autoclave itself cannot cause rust to form. In any
cases in which rust has developed on the autoclave or on the sterilized items inside, investigations have
consistently shown that this rust has been dragged into the autoclave from the outside by rusty instruments. We
must point out that rust can form on stainless-steel instruments made by even the best manufacturers.
One main cause of instrument rusting is improper treatment with chemical cleaning and disinfecting agents during
preparation for sterilization.
Preparation of instruments for sterilization
The problem of drag-in rust shows how important it is to properly prepare items for sterilization. It is urgently
necessary to observe the following procedures:
1. Clean and prepare (for example, by oiling) handpieces and contra angles as described in the instructions
provided by the manufacturers of these items.
2. Immediately after their medical use, all other instruments must be placed in a disinfection and/or cleaning
solution in accordance with UVV/VBG 103 and properly cleaned and disinfected there.
3. Always be sure to use the correct dosage of disinfection and/or cleaning agents in these solutions.
4. Important: Be sure to carefully follow the instructions for the length of time that the instruments must soak in
the solutions.
5. We also recommend the use of ultrasonic equipment, recommended cleaning and care equipment for
handpieces and contra angles, as well as thermal disinfecting techniques.
6. The proper cleaning of instruments is also essentially important in preventing particles of soiled matter from
separating from the instruments during sterilization and from clogging the filters, nozzles, and valves of the
autoclave. It is extremely important to use a brush to very carefully clean the locks, joints, and hinges of the
instruments before sterilization.
7. Important: Use a brush under running water to completely rinse all cleaning and disinfecting agents from
instruments before placing them in the autoclave. Residue of chemical cleaning and disinfecting agents
must by no means be allowed to enter the autoclave, since they will cause corrosion there.
8. As a final step before placing the instruments into the autoclave, rinse them with demineralized water, and dry
them well.
9. Be sure to use oil (as indicated in the manufacturers’ instructions) to prepare turbines and handpieces for
sterilization, in order to ensure their long service life.
Time of day (h:min:s)
Chamber pressure (bar)
Temperature (steam) (°C)
Program Start-Stop
14:27:12
0.02bar 25°C

14
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®23-B:
1. Tray mount “B” (MELAG art.-no. 40224) for loading of either a maximum of 4 trays, or 4 standard tray cassettes
2. Tray mount “C” (MELAG art.-no. 40242) 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, G, M; Type 17K,M,G,R; Type 23M,G,R, 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. 22420). 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. 22420).
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®23-B is not suitable for the sterilization of liquids.

User Manual for the Vacuklav®23-B
15
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:
4.5 Selection of the program__________________________________________________
Select the required program on the basis of the following criteria:
The physical properties of the items to be sterilized (especially their ability to resist high temperatures)
The type of packaging (you must use the “Universal program”, or the “Gentle program” if part or all of the load is
wrapped).
Press the button “Program selection” repeatedly to run through the following programs (and the initial position), and
to make your selection:
Program name / Display message Parameters / applications
Universal program at 134°C, 2 bar, and a sterilization time
of 3.5 min, for:
Sterilization of all kinds of wrapped items, especially instru-
ments, or mixed loads (wrapped and unwrapped)
Quick program at 134°C, 2 bar, and a sterilization time of
3.5 min, for:
Sterilization of only unwrapped instruments (and no tex-
tiles), for fast re-use of the sterilized items (you must inter-
rupt the drying cycle manually)
Gentle program at 121°C, 1 bar, and a sterilization time of
15 min, for: Sterilization of all kinds of wrapped items, es-
pecially larger amounts of textiles, and of items sensitive to
heat (plastic and rubber articles), and for mixed loads
(wrapped and unwrapped)
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 instru-
ments 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 instru-
ments that have already been disinfected.
CAUTION: Use only together with a permanently in-
stalled MELAsteam®Pistol (otherwise the system is
disabled.
See the Operator’s Manual for MELAsteam®.
Bowie & Dick Test Program at 134°C, 2 bar, and a sterili-
zation time of 3.5 min, for:
Functional testing of the autoclave (verification of steam
penetration by using special indicators)
Vacuum test program for:
Functional testing of the autoclave (verification of the vac-
uum seal of the autoclave by determining the leak rate).
Start this program when the autoclave is cold.
Initial position of the autoclave (no program selected)
Program
Universal-program
134°C wrapped
Program
Quick-program
134°C unwrapped
Program
Gentle-program
121°C wrapped
Program
Bowie&Dick test
134°C 2.2bar 3'
Program
Vacuum test
Programm
15:31:33
0.02bar 22°C
Program Start-Stop
Door
closed
Programm
Prion-Program
134°C wrapped 20'
Programm
MELAsteam Cleaning
2.3bar 60'

16
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.
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:
Program status: Shown on the display:
1. 1. Pulsing, consisting of evacuation (air re-
moval), until a programmed evacuation pres-
sure, and with steam injection until a slight
overpressure are reached. The display shows
the chamber pressure and the steam tempera-
ture.
2. 2. ... and additional pulsing steps
Additional pulsing (as described above) will
take place, depending on the program selected.
This continues until the required vacuum is
achieved and the required penetration of the
items with saturated steam have taken place.
3. Heating-up phase
The heating-up phase follows pulsing. Con-
tinued injection of steam into the chamber
increases the pressure and temperature, in
accordance with the saturated-steam curve,
until the programmed parameters are achieved.
4. Sterilization phase
When pressure and temperature are in accor-
dance with the saturated-steam curve, and
when the programmed required values are
reached, the actual sterilization time begins to
run. The display flashes between showing the
pressure / temperature, and showing the time
remaining in the sterilization phase.
5. Pressure release
After the sterilization phase has come to an
end, pressure release will follow, with simulta-
neous emptying of the steam generator. Pres-
sure and temperature fall.
Program Start-Stop
Start
Program Start-Stop
1. sub-atm.pulsing
–0.085 bar 22°C
Program Start-Stop
2. sub-atm.pulsing
–0.85 bar 70°C
Program Start-Stop
Heat up
1.80 bar 117°C
Program Start-Stop
Sterilization
still: 2 min, 12s
Program Start-Stop
Sterilization
2.18 bar 135°C
Program Start-Stop
Pressure release
0.85 bar 96°C

User Manual for the Vacuklav®23-B
17
Program status: Shown on the display:
6. Drying phase
After the pressure has been released, the
drying phase begins. After the drying phase
begins, it is possible to interrupt the program
without causing an error message. This is
because the actual sterilization phase is com-
plete. You should wait until the drying has
come to an end, however (unless you are
using the “Fast program”).
7. Ventilation
At the end of the drying period, the sterilization
chamber is vented in a pressure-compensation
process, until the pressure returns to normal
atmospheric level.
8. End of program
When the venting of the sterilization chamber
is complete, the program cycle is finished.
If a printer is connected to the autoclave, and if
the immediate-printout option is set to “Yes”, a
record of the sterilization cycle will be printed
out.
When the autoclave has automatically un-
locked the door, you can open the door to
remove the sterilized items.
Program Start-Stop
Ventilate
–0.12 bar 60°C
Program Start-Stop
Open door
please
Program Start-Stop
Quick-program
run successfully
Program Start-Stop
immediate removal:
press "STOP"
Program Start-Stop
Vacuum-drying
sin. 1' –0.9bar
Program Start-Stop
Please wait
door unlocking

18
Printout of cycle log___________________________________________________________
The printout of the cycle log contains the following information:
4.8 Removing the sterilized items _____________________________________________
You can remove the sterilized items after opening the door. Danger of burning! Do not touch the hot sterilization
chamber or the door of the autoclave unless you are wearing sufficient protection for your hands (gloves, etc.). Be
sure to use the proper tools (MELAG Tray Lifter or standard tray lifter) or hand protection (pot holders or gloves) to
remove the hot sterilized items from the autoclave.
4.9 Sterile storage __________________________________________________________
After removing sterilized items which are wrapped, check the package to determine whether it is damaged. If it is
damaged (broken package seals, for example), you must sterilize the contents once again. Important: If you must
sterilize the contents again, they must be wrapped in a new package.
The sterilized items must be sufficiently dry before proper sterile storage is possible. The Vacuklav®23-B provides
excellent drying if the complete program is allowed to run (i.e., without interrupting the drying process), and if the
loading instructions given in this manual are properly observed (see Section 4.3 above). Immediately after
Program which has started
Current date
Time of day when the program started
The daily cycle number
Pre-heat temperature
Conductivity of the demineralised / distilled
water
Program-sequence phases with the respective
values for steam pressure, steam tempera-
ture, and time (relative to the start of the pro-
gram).
Message showing results
Mean sterilisation temperature / deviations
Mean sterilisation pressure / deviations
Sterilisation time actually run
Time of day at end of program
Information line with totalled cycle meter, fac-
tory number, and software version no.
------------------------------------------
MELAG Vacuklav 23-B
------------------------------------------
Programm : Universal-Programm
134°C wrapped
Date : 07.07.2005
Time : 11:33:35 (Start)
Batch Nor.: 5
------------------------------------------
Preheating 116,5 °C
Conductivity 7 S/cm
Step of program Press. Temperat. Time
bar °C min
Start 0.03 70.1 00:00
1.Fractionation
Evacuation -0.90 67.2 05:00
Steam entry 0.10 98.8 14:02
2. Fractionation
Evacuation -0.80 66.9 19:01
Steam entry 0.10 100.9 25:43
3. Fractionation
Evacuation -0.80 78.8 30:43
Steam entry 0.10 101.1 39:02
Heat up 2.05 134.2 44:45
Steril. begin 2.05 134.2 44:45
Steril. end 2.19 136.0 48:15
Press. release 0.10 106.5 49:53
Vacuum drying
Drying begin -0,25 100.4 50:17
Drying press. -0,90 70,1 54:47
Drying end -0,35 60,5 59:44
Ventilation -0,18 57,1 64:44
End -0,05 57,1 64:44
------------------------------------------
PROGRAMM RUN SUCCESFULLY!
Temperature : 135.4 +0.1 /-0.1 °C
Oressure : 2.16 +0.01/-0.01 bar
Time of steril.: 3 min 30 s
Time : 12:38:54 (End)
==========================================
276 2001001567 3.31 1.16

User Manual for the Vacuklav®23-B
19
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.
Operator action Shown on the display:
1. Press the "Start-Stop" button.
A safety question will then appear for 5 seconds
on the display so that you can confirm that you
really want to abort the program. If you take no
further action, the program will continue as
usual after this 5 s has run out.
2. If you press the "Start-"Stop" button again
before the above-stated confirmation question
disappears from the screen (within 5 seconds),
then the program will prematurely stop.
If the autoclave is operating in a state in
overpressure (greater than normal atmospheric
pressure) when you abort a program, a
pressure-release step will follow. If the
autoclave is in a vacuum status, a venting step
will take place
3. After pressure compensation has been
achieved, the following two messages will
alternate on the display: “Termination end” and
“Confirmation with ‘–’ key”. If you press the “–”,
this will confirm that you wish to terminate the
program.
4. Press the “–” button to confirm that you really
want to abort the program. You will then see the
message “Please wait – Door unlocking.” The
display will then show the program which you
have selected.
Program Start-Stop
Stop program?
button "Stop"
Program Start-Stop
Pressure release
1.52 bar 112°C
Program Start-Stop
Program
stopped
Program Start-Stop
Stop / end
0.02 bar 88°C
Program Start-Stop
Acknowledge
with button "–"
Program Start-Stop
Gentle program
121°C wrapped

20
4.11.2 Interruption of a drying phase ___________________________________________________________
A program can be terminated after starting of the program step “Drying”, e.g. in case of needing an instrument
urgently for use. Since the sterilization has been completed, the items are sterilized at this point. Drying is crucial
for sterile storage. Depending on when the drying phase was terminated, in particular in the case of wrapped sterile
items, insufficient drying must be expected.
Warning! The EU standard EN 13060 stipulates very good drying results for “class B” – autoclaves, which are not
ensured by terminating the drying cycle. So in this case the sterilization was not executed according to “Class B”.
With the “Quick-program”, it is possible to interrupt the drying phase in order that the items can be immediately
used. Once the interrupted program comes to a stop, take the unpacked instruments out of the autoclave. The
intrinsic heat of the instruments will dry the moisture on them as they cool down. 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).
Operator action Shown on the display:
1. The autoclave is in the drying phase. The
display alternates between the two following
messages:
“Vacuum drying”, followed by the length of
drying time which has already run.
... and ...
The message showing how you can interrupt
the drying phase.
2. Press the "Start-Stop" button.
A safety question will then appear for 5 seconds
on the display so that you can confirm that you
really want to abort the program. If you take no
further action, the program will continue as
usual after this 5 s has run out.
3. If you press the "Start-"Stop" button again
before the above-stated confirmation question
disappears from the screen (within 5 seconds),
then the program will prematurely stop.
4
.The system will then vent the sterilization
chamber.
When the sterilization chamber has been
vented, the program sequence is finished. The
following status message will appear on the
display:
It will alternate with the following message:
And with the following message:
If a printer is connected to the autoclave, and if
you have selected “Yes” for the option for
immediate logging, the printer will immediately
log the message that the drying phase has
been interrupted.
Programm Start-Stop
Immediate removal
press "Stop"
Programm Start-Stop
Vacuum drying
sin.3' –0.9 bar 68°C
Program Start-Stop
Stop program ?
press "Stop"
Program Start-Stop
Drying
stopped
Program Start-Stop
Open door
please
Program Start-Stop
Quick program
run successfully
Program Start-Stop
Ventilate
–0.52 bar 112°C
Program Start-Stop
Drying
stopped