MELAG Vacuklav 41 B Plus Evolution User manual

Technical Manual
Vacuklav® 41 B+ Evolution
Vacuklav® 43 B+ Evolution
Steam sterilizer
from software version 3.218
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...............................................................................................................................................................6
Space requirements .............................................................................................................................................................7
Mains supply ........................................................................................................................................................................9
Water connection .................................................................................................................................................................9
System and network safety ................................................................................................................................................10
3 Setup and installation ........................................................................................................................................................12
Removing from the packaging ...........................................................................................................................................12
Cover caps or brackets for the MELAdem 40 ....................................................................................................................12
Connecting the power cable / removing accessory parts...................................................................................................13
Connecting the feed water supply (installation examples) .................................................................................................15
Connection to sewage system ...........................................................................................................................................19
Setting up the steam sterilizer............................................................................................................................................19
Test runs ............................................................................................................................................................................19
Instructing the users...........................................................................................................................................................19
4 Settings and adjustment....................................................................................................................................................20
Settings on the steam sterilizer ..........................................................................................................................................20
5 Frequently Asked Questions (FAQ)..................................................................................................................................22
What does the log name mean? ........................................................................................................................................22
How to format a CF card on the computer correctly? ........................................................................................................22
How to integrate the device in a (practice) network? .........................................................................................................23
How do I determine the IP address or network setting of a computer (Windows 7/10)? ...................................................25
What do the terms IP address, subnetwork and DHCP mean? .........................................................................................25
How can I check the software version of the steam sterilizer? ..........................................................................................26
6 Technical tables .................................................................................................................................................................27
Feed water quality..............................................................................................................................................................27
Precision and drift behaviour..............................................................................................................................................27
Nominal value tolerances...................................................................................................................................................29
Empty chamber test ...........................................................................................................................................................29
Pressure-time charts ..........................................................................................................................................................30

1 General guidelines
4
1 General guidelines
Read this manual carefully and in the correct order before setting up and commissioning the device. The
instructions include 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.
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
The device can be commissioned without installation material. Extra installation material is only required
given the connection of a water treatment unit or a direct waste water connection.
The following additional material can be ordered as required:
Qty. Article Art. no.
1 Water connection set for Premium-Class (41 B+ / 43 B+) 09034
1 Water outlet hose for steam sterilizers, 2 m 36585
1 Outlet hose for pressure release 41B+ Evo/43 B+ Evo 39181
1 Surface-mounted siphon 37410
1 Double hose grommet for siphon (with non-return valve for
connection to the flush siphon)
37400
1 Mounting set (EN 1717) for MELAdem 49600
1 3/4“ water tap with safety combination 37310
1 Additional water inflow tap with safety combination (for
connection to an existing angle valve)
58130
1 Water stop 01056
During initial commissioning, the steam sterilizer consumes three litres water (one-off) in accordance with
EN13060, Appendix C, to fill the double jacket. We recommend refilling the right-hand chamber of the in-
ternal storage tank immediately.

2 Installation requirements
6
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.
Properties Vacuklav 41 B+ Vacuklav 43 B+
Set-up surface level and horizontal
Max. floor loading (normal
operation)
3.70 kN/m² 3.37 kN/m²
Heat emission (with max. load) 1.7 kWh
Ambient temperature 5-40 °C (ideal range 16-26 °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
7
Space requirements
Dimensions Vacuklav 41 B+ Vacuklav 43 B+
Width A 46 cm 46 cm
Height B 56.5 cm 56.5 cm
Depth C 58 cm 69 cm
Clearance between the device
feet
C1 24 cm 35 cm
Clearance from rear device foot
up to the rear panel
C2 17.6 cm 17.6 cm
Min. clearance to the side D1 5 cm 5 cm
Min. clearance to the side of the
door hinge
D2 14 cm 14 cm
Min. clearance to the rear E 10 cm 10 cm
Free area with a fully-opened
door
F 52 cm 63 cm
Min. clearance above (pull-out /
with exhaust shaft)
G 5 / 20 cm 5 / 20 cm

2 Installation requirements
8
The area above the steam sterilizer should be freely accessible in order to enable easy filling of the stor-
age tank and good ventilation. The steam sterilizer works with a cooler on the rear of the device for the
cooling system. The function and life-span of the steam sterilizer can be affected if the heat dissipation
above the cooler is restricted in any way. As such, MELAG advise against incorporating the steam steriliz-
er and is only possible if sufficient air circulation is ensured.
Requirements for the incorporation of a device
If the incorporation of the device is absolutely necessary, one of the following measures must be imple-
mented:
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. Switching off the DRYtelligence (menuSettings >Intelligent drying).
4-5 cm
a
b
c
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 guar-
antee 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

2 Installation requirements
9
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 supply
Properties On-site requirements
Electricity supply socket with 220-240 V, 50/60 Hz, 3400 W*)
Building fuses a separate circuit with 16 A, RCD 30 mA (to guarantee continued
practice operation during steam sterilizer malfunction)
Other additional socket 230V, 50Hz for MELAprint60 label printer or
MELAprint42/44 log printer etc.
Length of power cable 2 m
*) max. voltage range 207-253 V
The mains socket must be freely accessible after installation so that the steam sterilizer can be taken from
the electricity supply at any time.
Water connection
Comply with the following specifications for the water connection if no manual filling or emptying is carried
out.
Feed water Wastewater
Connection in the
practice
via a water treatment unit e.g.
MELAdem
via the one-way outlet e.g. with the
water connection set
wall outlet, nominal width DN 40 or to a
siphon (flush outflow)
Installation height -- min. 30 cm under the steam sterilizer
Min. flow pressure 1.5 bar at 3 l/min --
Recommended flow
pressure
1.5-10 bar at 1.4 l/min --
Min. water pressure
(static)
2 bar --
Max. water pressure
(static)
10 bar --
Max. water temperature -- 98 °C
Water quality distilled or demineralized water in
accordance with EN 13060,
Appendix C
--
Measures for protecting
the drinking water
none (internal precautions against back-flow into the drinking water supply via
safety combination consisting of a back-flow preventer and pipe aerator; fused
in accordance with EN 1717)
Leakage water detector We recommend the installation of a leakage water detector with a cut-off valve
(e.g. MELAG water stop).

2 Installation requirements
10
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
CF card slot CF type I MELAflash CF card up to 4GB with
an FAT16 or FAT32 file system
Writing log data on a MELAflash CF
card
MELAflash CF card up to 4GB with
a FAT16 file system
Update of the device software
Ethernet Ethernet
IEEE 802.3
Switch port
(via CAT-5 patch cable)
MELAview
saving log data, querying device
data
MELAtrace
saving log data
FTP server
saving log data
MELAconnect (mobile app)
querying device data
Connection to the local network
(LAN)
MELAprint60
(via CAT-5 patch cable)
Label printing
MELAprint42/44
(via CAT-5 patch cable with network
adapter)
Log printing
NOTICE
When performing a device software update, use only the update data authorized by
MELAG for the corresponding device type.
Operating the device with memory media (CF card)
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.

2 Installation requirements
11
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 device is configured to obtain the IP address automatically from a DHCP server operat-
ed in a LAN.
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:
Log Port source Port
destination
Direction Purpose
TCP ≥1025 21 Outgoing FTP control
TCP Any ≥1025 Listening / incoming FTP (active) data transfer (device set
to FTP logging)
UDP 68 67 Outgoing Communication to DHCP server -
requests to the DHCP server
UDP 67 68 Listening / incoming Answers from DHCP server(s)
TCP Any 80 Listening Data transfer to the MELAconnect app
or web browser
TCP Any 65001 Listening / incoming Data transfer log data (device set to
TCP logging)
UDP 17784 17784 Outgoing Broadcast search log printer
TCP 50001 50000 Outgoing Data transfer to log printer
UDP 42380 3000 Outgoing Broadcast search label printer
TCP 52382 - 53382 9100 Outgoing Data transfer to label printer
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, legend, program, malfunction log 10kB 2-6kB
System log 64kB --
Graphic log 800kB 580kB
Data transfer MELAconnect 240bit/s per device c. 200bit/s per device
Data transfer, web interface (browser) 12kbits/s per connection --

3 Setup and installation
12
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.
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.
Cover caps or brackets for the MELAdem 40
Rectangular recesses are located on both side walls of the steam sterilizer for the application of brackets
for the MELAdem 40 water treatment unit. Should you decide not to use them, seal them with the cover
caps included in the scope of delivery.
Applying the cover caps
}Press the cover caps into the recesses as shown in
the figure.

3 Setup and installation
13
Applying the brackets for the MELAdem 40 water treatment unit
1. Guide the brackets into the recesses at an angle, with
the hooks pointing upwards.
2. Pull the brackets vertically downwards until they
engage.
3. Fix both brackets with the screws included with the
delivery.
Connecting the power cable / removing accessory parts
1. Connect the device power plug to the mains socket.
2. Switch on the device at the power switch. The display
shows the WELCOME screen.

3 Setup and installation
14
PLEASE NOTE
The display automatically switches to thePrograms & Tests menu after five seconds.
Then the steam sterilizer will attempt to pump water; this will trigger a malfunction
message if no feed water is available.
3. As soon as the WELCOME screen has appeared,
press the place of the second symbol from right in the
action bar and hold it depressed until the display
shows the the adjacent screen.
4. Open the door by pressing the door symbol
.
5. Remove all accessory parts from the device.

3 Setup and installation
15
Connecting the feed water supply (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 with the same water quality is possible after consultation
with MELAG.
Example 1: Using the internal water storage container
The steam sterilizer is supplied with feed water directly from the internal storage tank via a hose. This
means that no additional water connection apart from the mains connection is required. A float switch inte-
grated in the device notifies the absence of feed water. Programs can only be started after feed water has
been filled. The used feed water (wastewater) is collected in the wastewater chamber of the internal stor-
age tank and is to be emptied manually at a later point. A float switch in the wastewater chamber notifies a
full wastewater chamber.
3
6
5
7
2
4
1
1 Rear view of the steam sterilizer
2 Tank lid
3 Emergency overflow
4 One-way discharge
5 Feed water inflow
6 Pressure release connection
7 Mains socket

3 Setup and installation
16
Example 2: Using the MELAdem 40 ion exchanger
The most simple installation is the direct connection of the ion exchanger to the steam sterilizer feed water
inflow; this generates demineralized water from normal tap water. The MELAjet spray pistol can be in-
stalled as an option; this can be used to perform the final rinse of the instruments with demineralized water
before sterilization.
NOTICE
When connecting an external feed water supply it is necessary to connect an external
wastewater outflow as well.
There is a risk that hot wastewater might run through the emergency overflow.
The following steps are required to upgrade from feed water supply via a water treatment unit:
1. Empty both chambers of the internal storage tank.
2. Due to the difference in hose diameter, replace the existing feed water inflow fitting (5) in the steam
sterilizer with a hollow screw with feed water inflow fitting for the Ø 6x1 hose. Both parts are included
in the water connection set (art. no.25655).
3. Replace the two copper seals (art. no.42360) against the hollow screw - also in the water connection
set.
In this example, the used feed water (wastewater) is led directly into the siphon of the domestic water sup-
ply via the pressure release. This is performed using the Ø 8/6 mm PTFE hose (art. no.39180). Alterna-
tively, the wastewater can be led into the siphon via the one way discharge, see Example 3: Using the
MELAdem 47 reverse osmosis unit [}page18].
21
14
15
3
4
12
9
5
13
8 7
6
10
11
1 Rear view of the steam sterilizer 9 PTFE hose, 8/6 mm, per metre
2 Safety combination in accordance with EN1717 10 Filter for MELAdem
3 MELAdem 40 ion exchanger 11 Pressure release connection
4 MELAjet spray pistol for MELAdem 40 12 One-way discharge
5 Hollow screw with feed water inflow fitting for
Ø6x1 hose (replaces the fitting for the Ø8x1
hose, alternative straight)
13 Water tap, available on the building side

3 Setup and installation
17
6 Wall outlet, available on the building side
(DN40)
14 Water stop
7 Double chamber siphon1) 15 Mains socket
8 Double hose grommet for siphon (optional)2)
1) a surface-mounted siphon (separately-available) can be used as an alternative
2) not included in the scope of delivery of the steam sterilizer

3 Setup and installation
18
Example 3: Using the MELAdem 47 reverse osmosis unit
The reverse osmosis unit is connected directly to the feed water inflow of the steam sterilizer and uses
normal tap water to generate demineralized water.
NOTICE
When connecting an external feed water supply it is necessary to connect an external
wastewater outflow as well.
There is a risk that hot wastewater might run through the emergency overflow.
The following steps are required to upgrade from feed water supply via a water treatment unit:
1. Empty both chambers of the internal storage tank.
2. Due to the difference in hose diameter, replace the feed water inflow fitting (4) in the steam sterilizer
with a hollow screw with feed water inflow fitting for the Ø 6x1 hose. Both parts are included in the
water connection set (art. no.25655).
3. Replace the two copper seals for the hollow screw (art. no.42360) against the hollow screw - also in
the water connection set).
In this example, the used feed water (waste water) is led into the siphon of the domestic water supply via
the one-way drain. To this end, connect one end of the water outlet hose (15) to the device and the other
end to the double chamber siphon (9) via the double hose grommet (7). With a direct connection of the wa-
ter treatment unit to the domestic water supply, we recommend the additional installation of the leakage
water detector (water stop) with the cut-off valve and sensor (19).
2
1
19
5
14
4
18
11
7
8
6
3
16
15
9
13 12
17
10
1 Rear view of the steam sterilizer 11 Concentrate line of the reverse osmosis unit
2 Safety combination in accordance with
EN1717
12 Pressure tank of the reverse osmosis unit
3 One-way discharge 13 MELAdem 47 reverse osmosis unit
4 Feed water inflow fitting (swivel screw
connection for hose Ø6x1, alternative straight)
14 Permeate line (feed water) to the steam
sterilizer
5 MELAdem spigot 15 Water outlet hose for steam sterilizers, 2 m
(DN16)
6 Filter for MELAdem 16 Pressure release connection

3 Setup and installation
19
7 Double hose grommet for siphon 17 Water tap, available on the building side
8 Wall outlet, available on the building side
(DN40)
18 Mains socket
9 Double chamber siphon3) 19 Water stop4)
10 Wastewater adapter
Connection to sewage system
Version 1: Via the one-way drain
If you connect the one-way overflow hose from the steam sterilizer to the siphon of the domestic water
supply, you will require a 2m water outlet hose (art.no.36585), which you can order from MELAG.
Method 2: Via the pressure release
To connect the steam sterilizer to the wastewater directly, i.e. from the pressure release directly in the si-
phon of the domestic water supply, you can order a 1m water outlet hose from MELAG (art.no.39180).
Setting up the steam sterilizer
For a fault-free operation, the steam sterilizer must be set up horizontally by using a water level located
close to the sterilization-chamber flange. Then depending on the type of steam sterilizer, the front feet of
the unit must be unscrewed by about three (Vacuklav 40 B+/41 B+) or five (Vacuklav 43 B+/44 B+) rota-
tions in order to give the steam sterilizer a slight backwards tilt.
Test runs
Vacuum test with cold chamber
Perform a vacuum test with a cold empty 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.
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 declara-
tion of conformity regarding the Pressure Equipment Directive and the Medical Devices Act are included in
the manufacturer's inspection report.
3) a surface-mounted siphon (separately-available) can be used as an alternative
4) included in the scope of delivery of the steam sterilizer

4 Settings and adjustment
20
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.
Display settings
If required, working in theSettings menu, adjust the brightness, key tone and the touch-sensitivity.
Contact data of the service partner
Working in theSettings >Service menu, enter the name and address of the responsible service
partner.
Resetting the maintenance counter
Reset the maintenance counter in accordance with the instructions “Resetting the maintenance counter
upon initial commissioning and maintenance” (doc. PW_common).
User administration and logging
Instruct the user in the user administration and possible logging: consult user manual. If you require an ad-
min PIN, enter this and any further settings in the record of installation and setup.
IP addresses
NOTICE
The setting up in the (practice) network will require in-depth understanding of the
network technology.
Handling errors of IP addresses can result in malfunctions and data loss in your user
network.
nIP addresses may only be set by the (practice) network system administrator.
The device is equipped as standard with IP addresses which all belong to a common network with the sub-
net mask stated in the following table. These pre-set IP addresses listed in may not yet been assigned in
the (practice) network.
Works pre-setting of the device IP addresses
Device IP address Remarks
Steam sterilizer 192.168.40.40 Pre-set works side
Computer 192.168.40.140 Pre-set works side
Log printer 192.168.40.240 Pre-set works side
Label printer 192.168.40.160 Pre-set works side
Gateway 192.168.40.244 Not relevant within a network
Subnet mask 255.255.255.0 Possibly to be adopted by
customer network
Additional drying and further program modifications
The stages of the steam sterilizer programs (fractionating, heating, sterilizing, pressure release, drying and
aeration) and its parameters (pressure, temperature and time) are conform with the usual requirements
placed by a practice environment. The Additional drying function in the Settings menu provides a
standard possibility of influencing the course of the program run. Further alterations to the program run are