MELAG Vacuklav 23 B+ User manual

Technical Manual
Vacuklav® 23 B+
Vacuklav® 31 B+
Steam sterilizer
from software version 5.20
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 location...............................................................................................................................................................5
Electromagnetic environments.............................................................................................................................................5
Space requirements .............................................................................................................................................................6
On-site requirements............................................................................................................................................................8
System and network safety ..................................................................................................................................................9
3 Setup and installation ........................................................................................................................................................11
Removing from the packaging ...........................................................................................................................................11
Aligning the door seal sealing lips......................................................................................................................................11
Installation examples..........................................................................................................................................................13
Aligning the steam sterilizer ...............................................................................................................................................17
Test runs ............................................................................................................................................................................17
Instructing the users...........................................................................................................................................................17
4 Settings and adjustment....................................................................................................................................................18
Settings on the steam sterilizer ..........................................................................................................................................18
5 Technical tables .................................................................................................................................................................19
Feed water quality..............................................................................................................................................................19
Nominal value tolerances...................................................................................................................................................19
Empty chamber test ...........................................................................................................................................................20
Pressure-time charts ..........................................................................................................................................................20

1 General guidelines
4
1 General guidelines
Should the manual no longer be legible, is damaged or has been lost, you can download a new copy from
MELAG download centre at www.melag.com.
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 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) 2.7 kN/m² 3.2 kN/m²
Max. floor loading (hydraulic
pressure test)
3.4 kN/m² 3.9 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 compromised 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 40 cm --
Height 35 cm 46 cm 40 cm
Depth 16 cm 18 cm --
Diameter -- -- approx. 28 cm
Requirements for the installation of a device
If the installation of the device is mandatory, one of the following measures must be implemented:
1. It must be possible to pull out the device for operation (pos. a).
2. There must be an exhaust air shaft in the rear area of the installation space that discharges the warm
air upwards (pos. b).
3. There must be an exhaust air shaft in the rear area of the installation space that discharges the warm
air 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 authorised technicians.
uThe mains socket must be freely accessible after installation so that the steam sterilizer can be
disconnected from the electricity supply at any time.
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.
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 35 °C 70 °C
Recommended flow
pressure
1.5 bar at 3 l/min --
Min. water pressure
(static)
corresponding to the water treatment
unit1)
--
Max. water pressure
(static)
10 bar --
Max. water
consumption2)
approx. 700 ml --
Water quality Distilled or demineralised water in
accordance with EN 13060, Appendix
C
--
1) Optional when using a water treatment unit
2) In the Prion program with porous full load.

2 Installation requirements
9
Connection of 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.
System and network safety
The device is fitted with multiple external interfaces. Comply with the following information pertaining to the
use of these interfaces to ensure safe operation of the device, especially to ensure incorporation in the lo-
cal network (LAN).
Interfaces and connections
NOTICE
Only connect the hardware to the device which is listed in the following table. Only use
the software which has been intended for the purpose and approved by the
manufacturer.
Interface Type Hardware Purpose/software
COM port RS-232 PC MELAview
saving log data and querying device data
MELAtrace
saving log data
Modem Data transfer via points of presence
MELAnet Box Provides a LAN (Ethernet) interface for
the device, see below (Ethernet)
MELAview/MELAtrace
Saving log data
FTP server
saving log data
MELAprint42/44 Log printing
MELAflash CF card printer Writing log data on a MELAflash CF card
NOTICE
When performing a device software update, use only the update data authorized by
MELAG for the corresponding device type.

2 Installation requirements
10
Operating the device with memory media
To prevent data loss, only use memory media to save the log data with the following characteristics:
nFunctional capability (without malware etc.)
nWriteable
nFormatted with a correct file system
Perform regular data backup. Restrict access to the device and systems with access authorization to the
necessary circle of persons.
Only use MELAflash CF cards.
Operating the device in the local network (LAN)
NOTICE
Do not connect the device to a public network (e.g. the internet).
An Ethernet/IP-based network connection (LAN) is required to operate the device in a local network. In its
delivery state, the MELAnet Box IP address is 192.168.40.100.
NOTICE
Check the IP address carefully during the conversion for a manual configuration before
connecting the device to the LAN.
An incorrectly-entered IP address can cause IP conflicts in the network and thus disturb
another device in your network.
In the LAN with a firewall, only permit connections to and from the device which correspond to the intend-
ed use of the device. All ports not used are blocked on the device side.
The device is able to make the following connections as standard via MELAnet Box:
Log Source port Destination
port
Direction Aims
TCP ≥1025 21 Outgoing FTP control
TCP any ≥1025 Listening / incoming FTP (active) data transfer
(MELAnetBox set to FTP logging)
TCP any 80 Listening / incoming Data transfer to the web browser
TCP any 65001 Listening / incoming Data transfer of log data
(MELAnetBox set to TCP logging)
Network bandwidth / Quality of Service (QoS)
The device does not place any requirements on the LAN bandwidth for data transfer, that exceed the
standard time-out times of the respective logs.
Process Volume max. Volume normal
Transfer status, program, standby log 2kB 1.9kB
Graphic log 110kB 110kB

3 Setup and installation
11
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 commissioned 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 lips
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
12
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
13
Installation examples
The following pages provide examples for the recommended installation types for the feed water supply.
The connection of a different water treatment unit producing the same water quality is possible after con-
sultation 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.
A float switch installed in the storage and wastewater tank notifies insufficient feed water or a full wastewa-
ter chamber.
4
3
2
1
5
Pos. Description Art. no.
1 Silicon hose (9/6 mm, 5 m)*)ME34410
2 Plug for water drain*)ME31140
3 Feed water inlet hose*)ME34410
4 Feed water connection, Vacuklav*)ME21175
5 Mains connection**)--
*) present on the device side
**) present on the building side

3 Setup and installation
14
Example 2 – feed water supply from the MELAdem 40 ion exchanger
The wastewater is collected in the left-hand side chamber of the internal storage tank and is to be emptied
manually. In addition, the wastewater can be automatically discharged via the one-way drain (see Example
3 – feed water supply from the MELAdem47 reverse osmosis unit [}page16]).
2
1.1
1
3
4
5.2
4.1
1.2
9
5.1
4.2
6
4.3
7
10
8
Position Description Art. no. contained in
1 MELAjet spray pistol for MELAdem 40 (optional) ME27300 --
1.1 PUR hose (black) 6/4 mm (hose MELAjet) ME28820 ME27300
1.2 Swivel screw connection MELAjet ME53465 ME27300
2 Water stop (Leak water detector with cut-off valve and sensor,
optional)
ME01056 --
3 Water tap with safety combination**)-- --
4 MELAdem 40 ion exchanger ME01049 --
4.1 Filter for MELAdem ME48240 ME01049
4.2 PUR hose (black) 6/4 mm (inlet hose feed water) ME28820 ME01049
4.3 PUR hose (black) 6/4 mm (inlet hose MELAdem40) ME28820 ME01049
5 Mounting set (EN 1717) for MELAdem (optional) ME25410 --
5.1 Tap water supply hose EN 1717, 2.5 m ME24930 ME25410
5.2 Safety combination EN 1717 incl. holder ME82375 ME25410
6 Mains connection**)-- --
7 Cold water adapter 3/4" to 1/4" (direct connection water hose) ME09037 --
8 Back part cover for Vacuklav 23 B+ / 31 B+*)ME66790
9 Plug for water drain*)ME31140 --
10 Silicon hose (9/6 mm, 5 m)*)ME34410 --
*) present on the device side
**) present on the building side

3 Setup and installation
15
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 as
well.
Attaching the safety combination in accordance with EN 1717
1. Unscrew the back panel of the steam sterilizer.
2. Mount the safety combination (art. no. ME82375).
3. Connect the water inflow hose to the upper connection of the safety combination.
4. Connect the MELAdem 40 cold water adapter (art. no. ME09037) to the lower connection of the
safety combination.
5. Connect the water inlet hose for the MELAdem 40 to the MELAdem40 cold water adapter.
6. Guide the hoses through the opening provided at the bottom edge of the back panel.
7. Screw the back panel back on. Guide the hoses through the opening provided at the bottom edge of
the back panel.

3 Setup and installation
16
Example 3 – feed water supply from the MELAdem47 reverse osmosis
unit
The wastewater is collected on the left chamber of the storage tank and drains automatically via the one-
way outlet hose. The one-way outlet hose is connected to the siphon via the double hose grommet.
1.1
1.2
2
1.3
3
4.1
5.1
5.2
5.3
5.4
5.5
5.6
6
7
5.7
1.4
4.2
8
5.8
9
Position Description Art. no. contained in
1 Water connection set for Pro-Class ME09033 --
1.1 Add-on kit for wastewater ME26695 ME09033
1.2 ME09033 /
ME26695
1.3 Feed water connection of Euroklav/Vacuklav ME25655 ME09033
1.4 Wastewater nozzle for siphon with seal and clamp ME52615 ME09033 /
ME26695
2 Water stop (Leak water detector with cut-off valve and sensor,
optional)
ME01056 --
3 Water tap with safety combination**)-- --
4 Mounting set (EN 1717) for MELAdem ME25410 --
4.1 Tap water supply hose EN 1717, 2.5 m ME24930 ME25410
4.2 Safety combination EN 1717 incl. holder ME82375 ME25410
5 MELAdem 47 reverse osmosis unit ME01047 --
5.1 Filter for MELAdem ME48240 ME01047
5.2 PUR hose (black) 6/4 mm (inlet hose feed water) ME28820 ME01047
5.3 Pressure tank MELAdem 47 (with shut-off valve and hose) ME57065 ME01047
5.4 Water inflow hose (2.5 m) (inlet hose MELAdem47) ME37220 ME01047
5.5 MELAdem 47 reverse osmosis unit (without accessories) ME56740 ME01047
5.6 Wastewater adapter (G1/4” internal thread) ME56930 ME01047
5.7 Double support sleeve for an existing trap ME37400 ME01047
5.8 External tap for demineralised water (removal valve) ME91900 ME01047
6 Double-chamber siphon (optional) ME26635 --
7 Wall outlet NW40**)-- --
8 Mains connection**)-- --
9 Back part cover for Vacuklav 23 B+ / 31 B+*)ME66790
*) present on the device side
**) present on the building side

3 Setup and installation
17
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 as
well.
Attaching the safety combination in accordance with EN 1717
1. Unscrew the back panel of the steam sterilizer.
2. Mount the safety combination (art. no. ME82375).
3. Connect the water inflow hose to the upper connection of the safety combination.
4. Connect the water inlet hose to the MELAdem 47 reverse osmosis unit to the lower connection of the
safety combination.
5. Screw the back panel back on. Guide the hoses through the opening provided at the bottom edge of
the back panel.
Aligning the steam sterilizer
To ensure fault-free operation, the steam sterilizer must be set up horizontally with the aid of a spirit level
placed on the chamber seal face. 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 device.
Test runs
Vacuum test with a cold sterilization chamber
Perform a vacuum test with an empty, cold sterilization chamber and record the outcome in accordance
with record of installation and setup.
Universal-Program
If the vacuum test was successful, perform a Universal-Program with 1.5kg load (instruments) and record
the outcome in accordance with record of installation and setup.
Instructing the users
Explain all the user-typical features for the documentation and setting combinations for the operator.
Hand over the manufacturer’s inspection report. The declaration of conformity regarding the pressure
equipment directive and the Medical Devices Directive are included in the manufacturer's inspection re-
port.

4 Settings and adjustment
18
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
to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
19
5 Technical tables
Feed water quality
Minimum requirements placed on the feed water quality based on 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
20
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.
Schematic side and fore view of the sterilization chamber
Pressure-time charts
Universal-Program
134 °C/2.1 bar
Pressure (mbar)
3170
0
Fig.2: Pressure-time chart for the Universal-Program, 134 °C and 2.1 bar