MELAG Vacuklav 23 B+ User manual

Technical Manual
Vacuklav® 23 B+
Vacuklav® 31 B+
Steam sterilizer
from software version 5.17
EN
Read this manual carefully and in the correct order before setting up and commissioning the device. The instructions in-
clude important safety information. You also receive a User Manual with the device. Please store this manual and the
user manual carefully and in close proximity to the device. They represent a component of the product.

Contents
Contents
1 General guidelines ...............................................................................................................................................................4
Symbols used.......................................................................................................................................................................4
Formatting rules ...................................................................................................................................................................4
2 Installation requirements.....................................................................................................................................................5
Installation material ..............................................................................................................................................................5
Installation location...............................................................................................................................................................5
Electromagnetic environments.............................................................................................................................................5
Space requirements .............................................................................................................................................................6
On-site requirements............................................................................................................................................................8
3 Setup and installation ........................................................................................................................................................10
Removing from the packaging ...........................................................................................................................................10
Aligning the door seal sealing lip........................................................................................................................................10
Installation examples..........................................................................................................................................................12
Aligning the steam sterilizer ...............................................................................................................................................15
Test runs ............................................................................................................................................................................15
Transport............................................................................................................................................................................15
Instructing the users...........................................................................................................................................................15
4 Settings and adjustment....................................................................................................................................................16
Settings on the steam sterilizer ..........................................................................................................................................16
5 Technical tables .................................................................................................................................................................17
Feed water quality..............................................................................................................................................................17
Nominal value tolerances...................................................................................................................................................17
Empty chamber test ...........................................................................................................................................................18
Pressure-time chart............................................................................................................................................................18

1 General guidelines
4
1 General guidelines
Symbols used
Symbol Explanation
Indicates a dangerous situation, which if not avoided, could entail slight to life-
threatening injuries.
Draws your attention to a situation, which if not avoided, could result in damage to the
instruments, the practice fittings or the device.
Draws your attention to important information.
Formatting rules
Example Explanation
see Chapter 2 Reference to another text section within this document.
Universal-
Program
Words or phrases appearing on the display of the device are marked as display text.

2 Installation requirements
5
2 Installation requirements
Installation material
No installation material is required to commission the device. Extra installation material is only required
given the connection of a water treatment unit and/or a direct wastewater connection.
Additional material that can be ordered Art. no.
Water stop 01056
Water connection set 09033
Assembly set in accordance with EN 1717 for MELAdem 25410
Tank outlet upgrade kit (part of 09033) 26695
3/4" water tap with safety combination 37310
Double hose grommet for siphon (with trap) 37400
Surface-mounted siphon with double hose grommet 37410
Additional water inflow tap with safety combination (for connection to a pre-existing angle
valve)
58130
Installation location
WARNING
Failure to comply with the set-up conditions can result in injuries and/or damage to the
steam sterilizer.
nThe steam sterilizer should only be setup, installed and commissioned by persons
authorized by MELAG.
nThe steam sterilizer is not suitable for operation in explosive atmospheres.
nThe steam sterilizer is conceived for use outside the patient area. The device should be
located a minimum of 1.5m radius away from the treatment area.
Property Vacuklav 23 B+ Vacuklav 31 B+
Installation surface level and horizontal
Installation location interior of a building (dry and protected from dust)
Floor loading (normal operation) 2.3 kN/m² 2.7 kN/m²
Max. altitude 2000 m
Waste heat (with max. load) 0.9 kWh
Ambient temperature 5-40 °C (recommended max. 25 °C)
Relative humidity max. 80 % at 31 °C, decreases in a linear fashion up to max. 50 %
relative humidity at 40 °C
Steam egress can occur during operation. Do not set up the device in the immediate proximity of a smoke
detector. Maintain clearance from materials which could suffer damage from steam.
Electromagnetic environments
When assessing the Electromagnetic Compatibility (EMC) of this device, the emitted interference threshold
values for Class B devices and the stability for operation in an electromagnetic environment as described
in IEC 61326-1 were taken as the basis. The device is thus suitable for operation in all institutions and do-
mestic settings connected to a public mains power supply. The floor should be made of wood or concrete
or be tiled with ceramic tiling. If the floor is fitted with synthetic material, the relative humidity must amount
to a minimum of 30%.

2 Installation requirements
6
Space requirements
Fig.1: View from the front, the right and above
Dimensions Vacuklav 23 B+ Vacuklav 31 B+
Width A 42.5 cm
Height B 49 cm
Depth, total C 74 cm 62 cm
Clearance between the device feet C145 cm 37 cm
Clearance from rear device foot up to the rear panel C27 cm 8 cm
Min. clearance to the side D15 cm
Min. clearance to the side of the door hinge D210 cm
Min. clearance to the rear E 10 cm
Tank lid (width) F 23 cm
Tank lid (depth) F119.5 cm
Tank lid (clearance to the rear) F223 cm
Free area with a fully-opened door G 66 cm 54 cm
Min. clearance to the top (can be pulled out / with exhaust
shaft)
-- 5/20 cm
The area above the steam sterilizer should be freely accessible in order to enable easy filling of the
storage tank and to ensure good ventilation.

2 Installation requirements
7
The steam sterilizer works with a cooler on the rear of the device. The function and life-span of the steam
sterilizer can be compromized if heat dissipation via the cooler is restricted in any way. The steam sterilizer
may only be installed if sufficient air circulation can be guaranteed.
Additional space requirement for the feed water supply
Additional space is required for a storage container or a water treatment unit. It is also necessary to
guarantee free access to the hoses and cables leading from the steam sterilizer to the water treatment
unit.
Space requirements MELAdem 40 MELAdem 47
Water treatment unit Pressure tank
Width 32 cm 39 cm --
Height 35 cm 47 cm 51 cm
Depth 15 cm 15 cm --
Diameter -- -- 24 cm
Requirements for the incorporation of a device
If the incorporation of the device is absolutely necessary, one of the following measures must be
implemented:
1. The device must be able to be pulled out for operation (pos.a).
2. In the installation space, there must be an exhaust air duct in the rear area which diverts the warm air
upwards (pos.b).
3. In the installation space, there must be an exhaust air duct in the rear area which diverts the warm air
actively to the rear (pos.c).
4-5 cm
a
b
c

2 Installation requirements
8
On-site requirements
Mains supply
Implement the following safety measures when dealing with the cable and power plug:
uNever damage or alter the power plug or cable.
uNever bend or twist the power cable.
uNever remove the plug by pulling on the power cable. Always take a grip on the plug.
uNever place any heavy objects on the power cable.
uNever run the power cable over areas in which it could become trapped (e.g. doors or windows).
uNever lead the cable along a source of heat.
uNever use any nails, paper fasteners or similar objects to fix the cable.
uShould the power plug or cable suffer damage, switch off the device. The power cable or plug should
only be replaced by authorized technicians.
On-site requirements of the mains connection
Property
Electricity supply 220-240 V, 50/60 Hz
Max. voltage range 207-253 V
Building fuses separate power circuit with 16 A fuse, 30 mA RCD protection (to guarantee
continued practice operation during steam sterilizer malfunction)
Length of power cable*)1.35 m
Other Additional socket for the MELAprint 42/44 log printer etc.
*) Comply with the specifications in the connection diagram.
The mains socket must be freely accessible after set up so that the steam sterilizer can be disconnected
from the electricity supply at any time.

2 Installation requirements
9
Water connection
Feed water Wastewater
Connection in the
practice
Manual filling via the internal storage
tank
Optional: to a water treatment unit
e.g. MELAdem
Manual emptying via the internal
storage tank
Optional: automatically via the one-
way outlet with the MELAG upgrade
kit for the tank outlet
Wall outflow, nominal width DN 40 or
to a siphon (flush outflow)
Installation height -- min. 30 cm under the steam sterilizer
Max. water temperature -- 70 °C
Recommended flow
pressure
1.5 bar at 3 l/min --
Min. water pressure
(static)
corresponding water treatment unit1) --
Max. water pressure
(static)
10 bar --
Max. water
consumption2)
approx. 700 ml (23 B+)
approx. 700 ml (31 B+)
--
Water quality Distilled or demineralized water in
accordance with DIN EN 13060,
Appendix C
--
Connection to a water treatment unit
MELAdem 40 MELAdem 47
Permissible water
pressure
1.5-10 bar 2-6 bar
Water stop For insurance reasons, MELAG recommends the installation of a water stop
with a cut-off valve (e.g. from MELAG), as the MELAdem 40 / MELAdem 47
are under constant water pressure from the domestic water supply.
PLEASE NOTE
The outlet hose must be fitted at a constant decline without kinks or sagging. Deviations
to the installation arrangements require consultation with MELAG.
Failure to do so can result in malfunctions of the steam sterilizer.
1) Optional when using a water treatment unit
2) In the Prion-Program a with porous full load.

3 Setup and installation
10
3 Setup and installation
WARNING
Improper installation may lead to a short-circuit, fire, water damage or electrical shock.
This could result in serious injury.
nOnly have the device set up, installed and started up by people authorized by MELAG.
Removing from the packaging
CAUTION
Danger of injury from incorrect carrying.
Lifting and carrying too heavy a load can result in spinal injury. Failure to comply with
these provisions can result in crushing.
nThe device should always be carried by two people.
nUse the correct carrying straps to carry the device.
nComply with the safety regulations issued by your professional association.
1. Remove the steam sterilizer from the box using the carrying straps.
2. Unscrew the four screws from each side of the unit cover to remove the straps.
3. Then re-screw these screws without the flat washers.
4. Store the carrying straps and washers in a safe place.
5. Open the door and remove the trays and accessories immediately after switching on the device.
Aligning the door seal sealing lip
Long periods of storage with the door closed can result in the sealing lips of the door seal becoming stuck.
Align the sealing lips to prevent leaks.
Proceed as follows:
1. Remove the door seal.

3 Setup and installation
11
2. Press your thumb between the two sealing lips and
separate the sealing lips once around with your
thumb.
PLEASE NOTE
Note the differences in the widths of the sealing surfaces when inserting the door seal.
The door can only be shut correctly and the sterilization chamber sealed, if the door seal
sits correctly in the groove.
3. Insert the door seal into the groove.
ÊThe wide sealing surface points towards the
chamber.

3 Setup and installation
12
Installation examples
The following pages provide examples for the three recommended installation types for the feed water
supply. The connection of a different water treatment unit producing the same water quality is possible
after consultation with MELAG.
Example 1 – feed water supply from the internal storage tank (delivery
state)
Direct feed water supply from the internal storage tank without an additional water connection.
No further installation is required apart from the electrical connection.
The wastewater is collected in the left-hand side chamber of the storage tank and is to be emptied
manually.
The float switch installed in the storage and wastewater tank notifies insufficient feed water or a full waste-
water chamber.
4
3
2
1
5
6
7
Pos. Description
1 Tank lid
2 Spring safety valve
3 Sterile filter
4 One-way outlet
5 Feed water inflow
6 Mains connection
7 Cooler

3 Setup and installation
13
Example 2 – feed water supply from the MELAdem 40 ion exchanger
The wastewater will be collected in the left-hand side chamber the internal storage tank and released
manually or automatically via the one-way outlet. The one-way outlet hose is connected to the siphon via
the double hose grommet.
Hot wastewater can run off the emergency overflow. MELAG recommends to connect the steam sterilizer
to the siphon of the domestic water supply or to the MELAG double chamber siphon.
The MELAjet spray pistol enables the final rinsing of the instruments with demineralized water before
sterilization and is connected directly to the feed water inflow.
4
3
2
1
5
8
9
67
Pos. Description
1 MELAjet (optional)
2 Rear view of the steam sterilizer with cover plate
3 Water stop with cut-off valve and sensor (optional)*)
4 One-way outlet (optional)**)
5 Water inflow tap (provided on site)
6 MELAdem feed water filter
7 Feed water inflow fitting for hose 6x1
8 MELAdem40
9 Safety combination consisting of a backflow preventer and pipe aerator acc. to EN1717
*) Recommended with fixed water connection
**) Automatic wastewater outflow requires the upgrade set for wastewater connection to a siphon
(included in the MELAdem40/47 set).
PLEASE NOTE
Before converting from the standard version to a water treatment unit, you must first
empty the feed water side (right-hand chamber) of the internal storage tank. With
automatic one-way outlet, the wastewater side (left-hand chamber) must be emptied.
Fitting a safety combination in accordance with EN1717
1. Unscrew the rear panel of the steam sterilizer.
2. Lead the water inflow hose from the water inflow tap under the rear panel of the device and connect it
to the upper connection of the safety combination.
3. Connect the water inflow hose to the MELAdem on the upper connection of the safety combination.
4. Screw the rear panel back on.

3 Setup and installation
14
Example 3 – feed water supply from the MELAdem47 reverse osmosis
unit
The wastewater is collected in the left-hand side chamber of the storage tank and flows out via the one-
way outlet hose. The one-way outlet hose is connected to the siphon via the double hose grommet.
4
3
2
1
5
10
9
6
8
11
7
13
12
Pos. Description
1 Rear view of the steam sterilizer with cover plate
2 One-way outlet
3 Water stop with cut-off valve and sensor (optional)*)
4 Feed water inflow fitting for hose 6x1
5 Water inflow tap (provided on site)
6 MELAdem feed water filter
7 One-way outlet hose DN15
8 Feed water inflow hose
9 MELAdem47 with storage container and removal valve
10 Double chamber siphon
11 Double hose nozzle with trap
12 Concentrate outflow from MELAdem47
13 Safety combination consisting of a backflow preventer and pipe aerator acc. to EN1717
*) Recommended with fixed water connection
PLEASE NOTE
Before converting from the standard version to a water treatment unit, you must first
empty the feed water side (right-hand chamber) of the internal storage tank. With
automatic one-way outflow, the wastewater side (left-hand chamber) must be emptied.
Fitting a safety combination in accordance with EN1717
1. Unscrew the rear panel of the steam sterilizer.
2. Lead the water inflow hose from the water inflow tap under the rear panel of the device and connect it
to the upper connection of the safety combination.
3. Connect the water inflow hose to the MELAdem on the upper connection of the safety combination.
4. Screw the rear panel back on.

3 Setup and installation
15
Aligning the steam sterilizer
To enable malfunction-free operation, the steam sterilizer must be setup level using a spirit level placed on
the chamber flange. Then extend the fore device feet by five (Vacuklav23B+) or three (Vacuklav31B+)
revolutions to effect a slight rearwards slope of the steam sterilizer.
Test runs
Vacuum test with a cold sterilization chamber
Perform a vacuum test with an empty, cold sterilization chamber and record the outcome.
Universal-Program
If the vacuum test was successful, perform a Universal-Program with 1.5kg load (instruments) and record
the outcome.
Transport
Transport within the practice
NOTICE
Failure to observe these provisions can result in damage to the device and malfunction.
Comply with the following provisions when transporting the steam sterilizer within a room or the practice:
uEmpty both chambers of the internal storage tank.
uWhen using a water treatment unit and/or a wastewater hose, close the water inflow and remove the
hose connections on the rear of the device.
uShould you wish to leave the mount and trays or cassettes in the sterilization chamber during
transport, protect the surface of the round blank. To do so, place e.g. some foam or bubble wrap
between the round blank and mount.
uClose the door of the steam sterilizer before moving it.
Transport over long distances
NOTICE
Damage to the housing and the device interior as a result of using unsuitable transport
packaging.
nOnly transport the device in its original packaging or other suitable packaging.
Comply with the following provisions when transporting the steam sterilizer (e.g. a move or dispatch):
uBefore transporting the steam sterilizer over long distances, before dispatch or given the danger of
frost, an authorized technician must prepare the device in accordance with the instructions and empty
the storage tank entirely.
Instructing the users
Explain all the user-typical features for the documentation and setting combinations for the operator.
Hand over the user manual, the technical manual and the manufacturer's inspection report. The
declaration of conformity regarding the pressure equipment directive and the Medical Devices Act are
included in the manufacturer's inspection report.

4 Settings and adjustment
16
4 Settings and adjustment
Settings on the steam sterilizer
Date and time
Check the date and time and set if necessary: consult the user manual.
Feed water inflow
The feed water supply is effected either via the internal storage tank or via a separate water treatment unit
(e.g. MELAdem 40/MELAdem 47). Setup the feed water inflow depending on the installation version
INTERNAL orEXTERNAL.
Further information is provided in the device user manual.
Additional program options
TheAutom. preheating function heats the steam sterilizer chamber to a preheating temperature of
the respective program before program start, or holds this temperature between two program runs. This
will shorten the cycle times. It also reduces condensate formation on the chamber wall.
TheAdditional drying function increases the program by 50% for difficult drying tasks.
Further information is provided in the device user manual.
Counter stands
Working in theSETUP menu, you can access counter stands and other technical data of the steam
sterilizer.

5 Technical tables
17
5 Technical tables
Feed water quality
Minimum requirements placed on the feed water quality based on DIN EN 13060, Appendix C
Substance / property Feed water
Evaporation residue ≤10mg/l
Silicon oxide, SiO2≤1mg/l
Iron ≤0.2mg/l
Cadmium ≤0.005mg/l
Lead ≤0.05mg/l
Heavy metal traces apart from iron, cadmium, lead ≤0.1mg/l
Chloride ≤2mg/l
Phosphate ≤0.5mg/l
pH Value 5 to 7.5
Appearance ≤ colourless, clear, without sediments
Hardness ≤0.02mmol/l
Nominal value tolerances
Step Universal-
Program
Quick-
Program B
Prion-
Program
Gentle-
Program
Quick-
Program S
All values in mbar
P T P T P T P T P T
1. Frac-
tionation
80 +50/-20 ◄ ◄ ◄ ◄ ◄ ◄ 150 ◄ Evacuation
1400 +50/-30 ◄ ◄ ◄ ◄ ◄ ◄ ◄ ◄ Steam intake
2. Frac-
tionation
180 +50/-20 ◄ ◄ ◄ ◄ ◄ ◄ 250 ◄ Evacuation
1400 +50/-30 ◄ ◄ ◄ ◄ ◄ ◄ ◄ ◄ Steam intake
3. Frac-
tionation
180 +50/-20 ◄ ◄ ◄ ◄ ◄ ◄ --- --- Evacuation
1400 +50/-30 ◄ ◄ ◄ ◄ ◄ ◄ --- --- Steam intake
3050 +70/-30 ◄ ◄ ◄ ◄ 2060 ◄ ◄ ◄ Pressure increase
3050 +70/-30 ◄ ◄ ◄ ◄ 2060 ◄ ◄ ◄ Start of sterilization
3160 +90/-90 ◄ ◄ ◄ ◄ 2150 ◄ ◄ ◄ Sterilization
1200 +30/-90 ◄ ◄ ◄ ◄ ◄ ◄ ◄ ◄ Pressure release
Key:
P = Pressure
T = Tolerance
◄ As in Universal-Program

5 Technical tables
18
Empty chamber test
The coldest point in the sterilization chamber during the empty chamber test lies directly on the tempera-
ture sensor (see circular marking in the following figure). The temperature in the rest of the sterilization
chamber is almost the same all over.
Fig.2: Schematic side and fore view of the sterilization chamber
Pressure-time chart
Universal-Program
134 °C/2.1 bar
Pressure (mbar)
3170
0
Fig.3: Pressure-time chart for the Universal-Program, 134 °C and 2.1 bar

5 Technical tables
19
Quick-Program S
134 °C/2.1 bar
Pressure (mbar)
0
3170
Fig.4: Pressure-time chart for the Quick-Program S, 134 °C and 2.1 bar
Quick-Program B
134 °C/2,1 bar
Pressure (mbar)
0
3170
Fig.5: Pressure-time chart for the Quick-Program B, 134 °C and 2.1 bar

5 Technical tables
20
Gentle-Program
121 °C/1.1 bar
Pressure (mbar)
0
2170
Fig.6: Pressure-time chart for the Gentle-Program, 121 °C and 1.1 bar
Prion-Program
134 °C/2.1 bar
Pressure (mbar)
0
3170
Fig.7: Pressure-time chart for the Prion-Program, 134 °C and 2.1 bar