Technical manual

Vacuklav® 40 B+ Evolution
Vacuklav® 44 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
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.

0197
 Contents

Contents
1 General guidelines ............................................................................................................................................................... 4
Symbols used ...................................................................................................................................................................... 4
Formatting rules................................................................................................................................................................... 4

2 Installation requirements..................................................................................................................................................... 5
Installation location .............................................................................................................................................................. 5
Space requirements............................................................................................................................................................. 6
Mains supply........................................................................................................................................................................ 7
Water connection................................................................................................................................................................. 8
Protection in accordance with EN 1717............................................................................................................................... 8
System and network safety.................................................................................................................................................. 9

3 Setup and installation ........................................................................................................................................................ 11

Removing from the packaging ........................................................................................................................................... 11
Applying the cover caps at the side wall............................................................................................................................ 11
Connecting the power cable / removing accessory parts .................................................................................................. 12
Connecting the water inflow hose...................................................................................................................................... 12
Connecting the feed water supply (installation examples)................................................................................................. 13
Connecting the outlet hose ................................................................................................................................................ 17
Setting up the steam sterilizer ........................................................................................................................................... 17
Test runs............................................................................................................................................................................ 17
Instructing the users .......................................................................................................................................................... 17

4 Settings and adjustment.................................................................................................................................................... 18

Settings on the device ....................................................................................................................................................... 18

5 Frequently Asked Questions (FAQ).................................................................................................................................. 20

What does the log name mean?........................................................................................................................................ 20
How to format a CF card on the computer correctly? ........................................................................................................ 20
How to incorporate the device in a (practice) network?..................................................................................................... 21
How do I determine the IP address or network setting of a computer (Windows 7/10)? ................................................... 23
What do the terms IP address, subnetwork and DHCP mean?......................................................................................... 23
How can I check the software version of the steam sterilizer? .......................................................................................... 24

6 Technical tables ................................................................................................................................................................. 25

Feed water quality ............................................................................................................................................................. 25
Precision and drift behaviour ............................................................................................................................................. 25
Nominal value tolerances .................................................................................................................................................. 27
Empty chamber test........................................................................................................................................................... 27
Pressure-time charts.......................................................................................................................................................... 28
 1 General guidelines

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.
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 Description
Indicates a dangerous situation, which if not avoided, could entail slight to life-threatening in-
juries.
Draws your attention to a situation, which if not avoided, could result in damage to the instru-
ments, the practice fittings or the device.
Draws your attention to important information.

Formatting rules
Example Description
see Chapter 2 Reference to another text section within this document.
Universal- Words or phrases appearing on the display of the device are marked as display text.
Program

4
 2 Installation requirements

2 Installation requirements

Installation location

WARNING
Failure to comply with the setup conditions can result in injuries and/or damage to the device.
n The steam sterilizer should only be setup, installed and commissioned by persons authorised by MELAG.
n The steam sterilizer is not suitable for operation in explosive atmospheres.
n The steam sterilizer is conceived for use outside the patient care area. The device should be located a
minimum of 1.5 m radius away from the treatment area.

Property Vacuklav 40 B+ Vacuklav 44 B+

Installation surface level and horizontal
Installation location interior of a building (dry and protected from dust)
Floor loading (normal operation) 3.02 kN/m² 2.82 kN/m²
Floor loading (pressure resistance test) 3.54 kN/m² 3.45 kN/m²
Heat emission (with max. load) 0.95 kWh
Ambient temperature 5-40 °C (ideal range 16-26 °C)
Relative humidity max. 80 % at temperatures of up to 31 °C, max. 50 % at 40 °C (decreasing in
linear fashion in-between)
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 domestic 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 %.

5
 2 Installation requirements

Space requirements

Dimensions Vacuklav 40 B+ Vacuklav 44 B+

Width A 46 cm
Height B 56.5 cm
Depth, total*) 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
Min. clearance to the side D1 5 cm
Min. clearance to the side of the door hinge D2 14 cm
Min. clearance to the rear E 5 cm
Free space when door open fully F 52 cm 63 cm
Min. clearance to the top G 5 cm
)
* including safety combination in accordance with EN 1717
Maintain the side clearances when installing the steam sterilizer.

6
 2 Installation requirements

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 Storage container

Water treatment unit Pressure tank
Width 32 cm 40 cm -- 21 cm
Height 35 cm 46 cm 40 cm 38 cm
Depth 16 cm 18 cm -- 23 cm
Diameter -- -- approx. 28 cm --

Mains supply
Implement the following safety measures when dealing with the cable and power plug:
n Never damage or alter the power plug or cable.
n Never bend or twist the power cable.
n Never remove the plug by pulling on the power cable. Always take a grip on the plug.
n Never place any heavy objects on the power cable.
n Never run the power cable over areas in which it could become trapped (e.g. doors or windows).
n Never lead the cable along a source of heat.
n Never use any nails, paper fasteners or similar objects to fix the cable.
n Should the power plug or cable suffer damage, switch off the device. The power cable or plug should only be
replaced by authorised technicians.
n The mains socket must be freely accessible after installation so that the device can be disconnected from the
electrical mains at any time if necessary by pulling the mains plug.

On-site requirements of the mains connection

Property On-site requirements

Power supply socket with 220-240 V, 50/60 Hz
Electrical power 3400 W
Max. voltage range 207-253 V
Building fuse with 3400 W: separate electrical 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, MELAprint 42/44 log
printer etc.
Length of the power cable 2m

7
 2 Installation requirements

Water connection
Cold water Feed water Wastewater
Connection in the practice To the cold water cut-off to a water treatment unit, Wall outlet, nominal width
valve (water inflow tap) e.g. MELAdem DN 40 or to a U-trap (flush
G3/4“ outflow)
Installation height -- -- min. 30 cm under the steam
sterilizer
Min. flow pressure 0.5 bar at 3 l/min 1.5 bar at 3 l/min --
Recommended flow pres- 2-4 bar at 3 l/min 1.5-4 bar at 1.4 l/min --
sure
Min. static water pressure -- 2 bar --
Max. static water pressure 10 bar 10 bar --
Max. water temperature 20 °C (ideal 15 °C) 35 °C 80 °C
Water quality drinking water distilled or demineralised --
water in accordance with
EN 13060, Appendix C
Measures for protecting the none (internal precautions against back-flow into the drinking water supply via safety
drinking water combination consisting of a back-flow preventer and pipe aerator; secured in accordance
with EN 1717)
At first commissioning, the Vacuklav 40 B+ consumes 2.5 l and the Vacuklav 44 B+ consumes 3.5 l of feed water (in
accordance with EN 13060, Appendix C) once to fill the double jacket.

PLEASE NOTE
To prevent water damage, MELAG recommends the use of a leakage water detector e.g. the MELAG
water stop.

Protection in accordance with EN 1717

The connection of the steam sterilizer to the water supply is comparable with the connection of a washing machine in a
domestic context. In general, the connection of consumers to the drinking water network should be performed in
accordance with EN 1717, so that the drinking water supply is protected against contamination through the possible flow
back of the water. The steam sterilizer was developed in accordance with all the requirements of EN 1717 and is
equipped with a pre-fitted safety combination on its rear panel.
Many buildings are already equipped with a safety combination. Ask your plumber. In practice, it is often advantageous
to use a water inflow tap with a pre-fitted safety combination consisting of a back-flow preventer and a pipe aerator. To
ensure a standard-conform connection to the steam sterilizer independently of the building installation, MELAG
recommends two versions, see Connecting the water inflow hose [} Page 12].

8
 2 Installation requirements

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 local 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 CF card up to 4 GB with an FAT16 or Writing log data on a CF card
FAT32 file system
CF card up to 4 GB with a FAT16 file Device software update
system
Ethernet Ethernet Switch port MELAview Service
IEEE 802.3 (via CAT-5 patch cable) 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 Label printing
(via CAT-5 patch cable)
MELAprint 42/44 Log printing
(via CAT-5 patch cable with network
adapter)

NOTICE
When performing a device software update, use only the update data authorised by MELAG for the
corresponding device type.

Operating the device with memory media

To prevent data loss, only use memory media to save the log data with the following characteristics:
n functional (without malware, etc.)
n writeable
n formatted with a correct file system
Perform regular data backup. Restrict access to the device and systems with access authorisation to the necessary circle
of persons.
Only use CF cards.

9
 2 Installation requirements

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 operated 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 intended 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 Source port Destination Direction Purpose
port
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 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 the log printer
UDP 42380 3000 Outgoing Broadcast search label printer
TCP 52382 - 53382 9100 Outgoing Data transfer to the 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 approx. 200 bit/s per device
Data transfer, web interface (browser) 12 kbits/s per connection --

10
 3 Setup and installation

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.
n Only have the device set up, installed and commissioned by people authorised 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.
n The device should always be carried by two people.
n Use the correct carrying straps to carry the device.
n Comply with the safety regulations that apply to you.

1. Lift the device out of the box by the carrying straps.

2. Unscrew the four screws from each side of the unit cover to remove the straps.
3. Screw the screws back in tightly without washers.
4. Store the carrying straps and washers in a safe place.
5. After switching on the device, immediately open the door and remove the tablets and the accessories.

Applying the cover caps at the side wall

There are rectangular recesses on both side walls of the steam sterilizer for attaching the mounts of the water treatment
unit MELAdem 40. Close the recesses with the cover caps (included in the scope of delivery) if you are not using a water
treatment unit.

u Press the cover caps into the recesses as shown in the figure.

For further information see user manual MELAdem 40.

11
 3 Setup and installation

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.

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.

Connecting the water inflow hose

PLEASE NOTE
To prevent water damage, MELAG recommends the use of a leakage water detector e.g. the MELAG
water stop.

Method 1: Connection to a separate water line

1. Install the leakage water detector (optional).

2. Check whether the water inflow tap is fitted with a back-flow preventer and a pipe aerator.

12
 3 Setup and installation

3. If not, replace it with a MELAG water inflow tap with an integrated safety combination, see Connecting the feed
water supply (installation examples) [} Page 13].
4. Connect the steam sterilizer water inflow hose (DN 16) to the water inflow tap with a 1/2“ collar.

Method 2: Connection to an existing angle valve

To protect the drinking water, a cooling water connection may only be connected to a water inflow tap with an integrated
safety combination.

1. Install the leakage water detector (optional).

2. Connect an additional water inflow tap with an integrated MELAG safety combination to the angle valve, see
Connecting the feed water supply (installation examples) [} Page 13].
3. Connect the steam sterilizer water inflow hose (DN 16) to the water inflow tap.

NOTICE
Do not connect any further devices to the angle valve.
This could result in malfunctions in the cooling water system.

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.

PLEASE NOTE
For detailed information on the cold water connection of the water treatment unit, see the user manual
of the unit.

13
 3 Setup and installation

Example 1: Using a separate storage container

The steam sterilizer supplies with feed water from the storage container via the suction hose supplied. The maximum
suction height is 1.5 m. The storage container can also be located next to the steam sterilizer. The wastewater is led via
the drain hose into the rinse drain (siphon).

2
3
14
4

13
6
10.1
12
6.1
7
8

11 10 9

Pos. Description Art. no. Note

1 Safety combination EN 1717 incl. holder ME82375 present on device-side
2 Hose safety combination to water supply ME25975 present on device-side
3 Solenoid valve “cooling water” ME46995 present on device-side
4 Connection branch for wastewater hose ME21334 present on device-side
5 Feed water connection ME37242 included in delivery
6 Hose for water drain of steam sterilizers, 2 m ME36585 included in delivery
6.1 Wastewater nozzle for siphon with seal and clamp ME52615 optionally available to order
7 Wall outlet NW 40 -- on-site
8 Double-chamber siphon ME26635 included in delivery
9 Double support sleeve for an existing trap (optional) ME37400 optionally available to order
10 Storage container ME00244 optionally available to order
10.1 Hose PTFE 6/4 mm (5 m) ME39310 included in ME00244
11 Water inlet hose (2.5 m, complies with EN 1717) ME24930 optionally available to order
12 Water stop (leakage water detector with shut-off valve and ME01056 optionally available to order
probe) (optional)
13 Water tap with safety combination -- on-site
14 Mains connection -- on-site

14
 3 Setup and installation

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 demineralised water from normal tap water. The MELAjet spray gun can be installed as an option.
The wastewater is led via the drain hose into the rinse drain (siphon).

1 2 2.1
3

3.1
14 15

3.2
2.2

13 12 11 10 2.3 9 9.1

8 7

Pos. Description Art. no. Note

1 Safety combination EN 1717 incl. holder ME82375 present on device-side
2 MELAdem 40 ion exchanger ME01049 optionally available to order
2.1 PUR hose (6/4 mm, inlet hose MELAdem 40) ME28820 included in ME01049
2.2 PUR hose (6/4 mm, feed water inlet hose) ME28820 included in ME01049
2.3 Filter for MELAdem ME48240 included in ME01049
3 MELAjet spray pistol ME27300 optionally available to order
3.1 PUR hose (6/4 mm, MELAjet hose) ME28820 included in ME27300
3.2 Feed water inlet connection (swivel screw connection) ME53465 included in ME27300
MELAjet
4 Hose safety combination to water supply ME25975 present on device-side
5 Water branch ME37241 optionally available to order
6 Wall outlet NW 40 -- on-site
7 Double-chamber siphon ME26635 included in delivery
8 Double support sleeve for an existing trap ME37400 optionally available to order
9 Hose for water drain of steam sterilizers, 2 m ME36585 included in delivery
9.1 Wastewater nozzle for siphon with seal and clamp ME52615 included in ME36585
10 Connection branch for wastewater hose ME21334 present on device-side
11 Solenoid valve “cooling water” (cooling water inlet) ME46995 present on device-side
12 Water inlet hose (2.5 m, complies with EN 1717) ME24930 included in delivery
13 Water tap with safety combination -- on-site
14 Water stop (leakage water detector with shut-off valve and ME01056 optionally available to order
probe)
15 Mains connection -- on-site

15
 3 Setup and installation

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 demineralised water.
The wastewater is led via the drain hose into the rinse drain (siphon).

2.1
3

5
13
2.2

12 9 2.3
8
2.4
2.9
11 6
8.1
2.8
10
2.7
2.5 7
2.6

Pos. Description Art. no. Note

1 Safety combination EN 1717 incl. holder ME82375 optionally available to order
2 MELAdem 47 reverse osmosis unit ME01047 optionally available to order
2.1 Y-fitting for water supply with seal ME37315 included in ME01047
2.2 External tap for demineralised water ME91900 included in ME01047
2.3 Filter for MELAdem ME48240 included in ME01047
2.4 Double support sleeve for an existing trap ME37400 included in ME01047
2.5 Wastewater adapter (G1/4” internal thread) ME56930 included in ME01047
2.6 Pressure tank MELAdem 47 (with shut-off valve and hose) ME57065 included in ME01047
2.7 MELAdem 47 reverse osmosis unit (without accessories) ME56740 included in ME01047
2.8 Water inflow hose (2.5 m) (inlet hose MELAdem 47) ME37220 included in ME01047
2.9 PUR hose (6/4 mm, feed water inlet hose) ME28820 included in ME01047
3 Hose safety combination to water supply ME25975 present on device-side
4 Solenoid valve “cooling water” ME46995 present on device-side
5 Feed water connection ME37242 optionally available to order
6 Wall outlet NW 40 -- on-site
7 Double-chamber siphon ME26635 included in delivery
8 Hose for water drain of steam sterilizers, 2 m ME36585 included in delivery
8.1 Wastewater nozzle for siphon with seal and clamp ME52615 included in ME36585
9 Connection branch for wastewater hose ME21334 present on device-side
10 Water stop (leakage water detector with shut-off valve and ME01056 optionally available to order
probe)
11 Water inlet hose (2.5 m, complies with EN 1717) ME24930 on-site
12 Water tap with safety combination -- on-site
13 Mains connection -- on-site

16
 3 Setup and installation

Connecting the outlet hose

Method 1: Direct wall drain
ü The drain is located at least 30 cm below the device.
u Connect the drain hose supplied to the rear of the device and connect it to the wall drain (DN 40) of the practice,
preferably using the surface-mounted siphon from MELAG (art. no. ME37410). Make sure that the hose is installed
free of pockets and with a steady slope.

Method 2: Connection to a sink drain

ü The drain is located at least 30 cm below the device.
u Connect the drain hose supplied to the back of the device and connect it to the sink drain (siphon) of the practice.
Make sure that the hose is installed free of pockets and with a steady slope.
For a quieter water discharge, it is recommended to replace the double-chamber siphon included in the delivery with the
existing siphon.

Setting up the steam sterilizer

For malfunction-free operation, set up the device horizontally using a spirit level resting against the chamber flange.
Depending on the type of the steam sterilizer the front feet of the device must be unscrewed by about three
(Vacuklav 40 B+/41 B+) or five (Vacuklav 43 B+/44 B+) rotations in order to give the steam sterilizer a slight backwards
tilt.

Test runs
Vacuum test with cold sterilization chamber
Perform a Vacuum test with an empty cold sterilization chamber and record the result.

Universal-Program
If the vacuum test was successful, run a Universal-Program with 1.5 kg load (instruments) and record the result.

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 of the Pressure Equipment Directive and
the Medical Device Directive are included in the manufacturer's inspection report.

17
 4 Settings and adjustment

4 Settings and adjustment

Settings on the device

Date and time
Check the date and time and set if necessary, see User manual.

Display settings
If required, working in the Settings menu, adjust the brightness, key tone and the touch-sensitivity, see User manual.

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 admin 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.
n IP 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 subnet 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 ex works
computer 192.168.40.140 Pre-set ex works
Log printer 192.168.40.240 Pre-set ex works
Label printer 192.168.40.160 Pre-set ex works
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 possible in each individual case and will still
ensure the effectiveness of the sterilization, but may only be performed by authorized technicians. Please consult your
stockist or MELAG.

18
 4 Settings and adjustment

System and status log

Output a system and status log and document this on the record of installation and setup.

Counter stands
Working in menu Info & Status, you can access counter stands and other up-to-date technical data.

19
 5 Frequently Asked Questions (FAQ)

5 Frequently Asked Questions (FAQ)

What does the log name mean?

Complete encoding of both the serial number and the total batch number is performed in the 8 digit log name. Manually
re-named files are always easy to identify but not to be recommended. A log name is never assigned twice. The log
name achieves good log sortability.
Knowledge of the encoding within the name of the log file is not necessary, as a double-click on the file reveals the
content and thus serial number and total batch number immediately. This requires assignment of a log file to a text
editor.
Example
H 2 0 S E 0 0 F . PR0
Meaning Serial number Total File ending
Year of Type Production no. batches
construct.
Explanation H...2017 0…40 B+ Example: .PRO = suc-
I...2018 1...41 B+ cessfully ended program
J...2019 2...43 B+
K...2020 4...44 B+

Date and time of the log files

The date and time of the log files in Windows explorer are identical with the time of the program start, provided of course
that the files were saved on the corresponding medium via immediate output. The information is lost upon subsequent
collected issue on a medium or e-mail dispatch.

How to format a CF card on the computer correctly?

The CF card should only be formatted on the device. In exceptional circumstances, this can be performed on the
computer. The CF card used may have a max. memory space of 4 GB and must be formatted with the file system FAT16
or FAT32. CF cards from which a software update is to be performed may only be formatted in a FAT16 file system.
The device can only file or read data on CF cards formatted in this way. CF cards supplied by MELAG fulfil these
requirements and have already been formatted.

20
 5 Frequently Asked Questions (FAQ)

Formatting on a computer is described in Windows 7:

1. Insert the CF card in the MELAflash card reader

installed and connected to the computer.
2. Working in Windows Explorer “Computer” > “Devices
with Removable Storage” select the corresponding
drive and open the menu window by right-click.
3. Working in the menu window, select the “Format...”
option. The adjacent dialogue window opens.
4. Working under file system, select the format “FAT
(Default)”.
5. Working under “Allocation unit size” Windows
automatically selects the appropriate allocation unit for
the respective size of the CF card. The allocation unit
is dependent of the size of the CF card.
6. Click on “Start”.

How to incorporate the device in a (practice) network?

Arrange for the IT company that services your network to incorporate your device in the network.
Note the following:
n The computer is equipped with a network card with a RJ45 bushing (LAN).
n Log archive via FTP: An FTP server*) or an FTP service is installed on the computer that permits the creation of
users with write permission independent of the operating system.
n Log output via TCP: A suitable program, e.g. MELAtrace, is installed.
*) We recommend using the MELAG FTP server to incorporate network-compatible MELAG devices in a (practice)
network.

1. Setting up the FTP server (only with log output via FTP)
A computer must be determined in the (practice) network on which the FTP server should run. This program receives the
logs via data transfer. The steam sterilizer searches for the FTP server using the IP address set in the steam sterilizer
and logs on. The logs of the completed program are saved on this computer later. When choosing the computer, be
aware that it would be advantageous to integrate the logs thus saved in the practice automatic data saving system.
MELAG provides its own FTP program free of charge. Using the MELAG FTP server enables the registration of multiple
devices as users simultaneously and the receipt of data from the steam sterilizer and other devices such as a washer-
disinfector. The FTP server supports the so-called multithread capability. You can determine the folder in which the
device directory and log files are to be stored in the FTP server program.
1. Working in the (practice) network, determine which computer should run on the FTP server.
2. If an FTP server has not yet been installed, install the MELAG FTP server for preference and set the steam sterilizer
as user with a user name and password.
3. Working on the steam sterilizer, set the computer as the log output medium (log output via FTP). Further information
regarding log output is set out in the user manual (chapter Settings, Logging).

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 5 Frequently Asked Questions (FAQ)

2. Connecting the network cable

u Connect the network cable (crossover) to any network data connection of the device and connect it to the (practice)
network. If "smart switches" are used in the network, the cable type (1:1 or crossover cable) does not matter.

PLEASE NOTE
Should you wish to connect the steam sterilizer to a computer directly without a network connection,
use a 1:1 cable.

3. Adjusting IP addresses in the steam sterilizer

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.
n IP addresses may only be set by the (practice) network system administrator.

NOTICE
If you use a subnet mask other than that set in the steam sterilizer, an IT specialist should adapt all the
IP addresses in the device.

As a matter of course: The selected computer must always have a fixed IP address, regardless of whether it is in an
automatically or manually configured network. In an automatically configured network, it is necessary to inform the DHCP
server of the area with the number or the number itself as a static IP address(es). The computer can also be assigned
multiple IP addresses if those already present in the computer are not to be used.
1. Ask the IT administrator for the IP address of the computer first or find out yourself.
2. Check whether the computer has a dynamic or a fixed IP address.
Ê The computer must be issued with a fixed IP address. Change this if necessary.
With a manually-configured (practice) network:
1. Check whether the steam sterilizer and the computer belong to a subnetwork. In the majority of cases, this usually
means that the first three numbers of the IP address of the sub network should correspond (e.g. 192.168.40.xx).
The IP addresses of the steam sterilizer and the computer must be different in the fourth number block (e.g. IP
steam sterilizer: 192.168.40.20 and IP computer: 192.168.40.140).
Ê If the IP addresses of both devices do not belong to a subnetwork, change the steam sterilizer IP address
directly in the steam sterilizer.
2. Check whether the IP address of the computer set in the steam sterilizer is correct.
Ê If the IP address of the practice computer deviates from the IP address set in the steam sterilizer, adapt the IP
address of the computer in the steam sterilizer.

With a dynamic (practice) network (DHCP):

The steam sterilizer can also be administered automatically in a dynamic network. If log output is made via FTP, the
computer should be issued with a fixed IP address which is entered on the steam sterilizer.

22
 5 Frequently Asked Questions (FAQ)

1. Working in the Settings menu > Logging, set the IP address of

the steam sterilizer to DHCP.

2. Check whether the IP address of the computer set in the steam

sterilizer is correct.
Ê If the IP address of the practice computer deviates from the IP
address set in the steam sterilizer, adapt the IP address of the
computer in the steam sterilizer.

PLEASE NOTE
If a DHCP server cannot be located in the (practice) network, the steam sterilizer will automatically
receive the pre-set static IP address.

How do I determine the IP address or network setting of a computer

(Windows 7/10)?
1. Open “Network and Sharing Center” or the network and internet settings.
2. Open the Properties window under “Local Area Connection” > right-click on “Properties”.
3. Working in the Properties window, select “Internet Protocol Version 4 (TCP/IPv4)” and click on push-button
“Properties”.
Ê If “Obtain the IP address automatically” is selected in the opening dialogue window, the computer is addressed
dynamically in the (practice) network i.e. via DHCP.

What do the terms IP address, subnetwork and DHCP mean?

Term Meaning
IP address The IP address is a identifier of the computer or device expressed in numbers in a network.
It serves to identify the computer or device with four number blocks (e.g. 192.168.88.8).
Subnetwork Every IP address is divided into a network and a device (host) section. The division is per-
formed via the subnetwork mask (also: subnet/sub-net mask). The network section of the
IP addresses must be identical so that the devices can communicate with each other. With
a network entry mask = 255.255.255.0 (the most often) the first three numbers (e.g.
192.168.88.x) must be the same. The device part of the IP address is assigned individually
and only once. The first (network itself) and the highest (broadcast) device address may
not be issued.
DHCP The IP addresses are automatically issued in a computer network via DHCP (= Dynamic
Host Configuration Protocol) i.e. the IP addresses need not be entered manually in every
device in the network. The precondition is the presence of a DHCP server in a network.

23
 5 Frequently Asked Questions (FAQ)

How can I check the software version of the steam sterilizer?

u You can read off the software version of the activated steam
sterilizer from the Info & Status menu.

24
 6 Technical tables

6 Technical tables

Feed water quality

Minimum requirements to the feed water following 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
Traces of heavy metal apart from ≤ 0.1 mg/l
iron, cadmium, lead
Chloride ≤ 2 mg/l
Phosphate ≤ 0.5 mg/l
pH value 5 - 7.5
Appearance ≤ colourless, clear, without sediments
Hardness ≤ 0.02 mmol/l

Precision and drift behaviour

Sensors

Temperature sensors

Sensor type PT 1000 Class A according to DIN EN 60751

Precision (at 135 °C) ± 0.42 K
Drift per year ± 0.05 K
Drift in 5 years ± 0.25 K

Pressure sensor

Sensor type Piezoresistant absolute pressure sensor 0 to 4000 mbar

Precision ± 0.3 % corresponds to ± 12 mbar corresponds to approx. ± 0.13 K steam
Drift per year ± 0.2 % corresponds to ± 8 mbar corresponds to approx. ± 0.09 K steam
Drift in 5 years ± 1.0 % corresponds to ± 40 mbar corresponds to approx. ± 0.44 K steam

Measuring chains

Measuring chain for the temperature measurement on the electronics (without sensor)

Precision (at 135 °C) ± 0.2 K

Drift per year ± 0.005 K
Drift in 5 years ± 0.025 K

Measuring chain for the pressure measurement on the electronics (without sensor)

Precision ± 0.2 % corresponds to ± 8.0 mbar corresponds to approx. ± 0.09 K steam

Drift per year ± 0.004 % corresponds to ± 0.16 mbar corresponds to approx. ± 0.017 K steam
Drift in 5 years ± 0.02 % corresponds to ± 0.8 mbar corresponds to approx. ± 0.09 K steam

25
 6 Technical tables

After 1 year

Entire measuring chain of the temperature measurement

Precision (at 135 °C) at pure addition of individual errors approx. ± 0.70 K
Precision (at 135 °C) according to Gauss' law of propagation approx. ± 0.47 K

Entire measuring chain of the pressure measurement

Precision at pure addition of indiv. errors ± 0.70 % corresponds to ± 28.0 mbar corresponds to
approx. ± 0.30 K steam temperature
Precision per Gauss' law of propagation ± 0.41 % corresponds to ± 16.5 mbar corresponds to
approx. ± 0.18 K steam temperature

After 5 years

Entire measuring chain of the temperature measurement

Precision (at 135 °C) at pure addition of individual errors approx. ± 0.70 K
Precision (at 135 °C) according to Gauss' law of propagation approx. ± 0.47 K

Entire measuring chain of the pressure measurement

Precision at pure addition of individual er- ± 0.70 % corresponds to ± 28.0 mbar corresponds to
rors approx. ± 0.30 K steam temperature
Precision per Gauss' law of propagation ± 0.41 % corresponds to ± 16.5 mbar corresponds to
approx. ± 0.18 K steam temperature

26
 6 Technical tables

Nominal value tolerances

Universal-Program Quick-Program Prion-Program Gentle-Program Quick-
B Program S
Step Press. P Tolerance P Tol. P Tol. P Tol. P Tol. All values in mbar
SK11 1600 +100/- 20 ◄ ◄ ◄ ◄ ◄ ◄ ◄ ◄ Steam intake 1
SK12 1300 + 20/- 50 ◄ ◄ ◄ ◄ ◄ ◄ ◄ ◄ Press. release
SK11 1600 +100/- 20 ◄ ◄ ◄ ◄ ◄ ◄ --- --- Steam intake
SK12 1300 + 20/- 50 ◄ ◄ ◄ ◄ ◄ ◄ --- --- Press. release
SK21 1600 +100/- 20 ◄ ◄ ◄ ◄ ◄ ◄ ◄ ◄ Steam intake
SK22 1300 + 20/- 50 ◄ ◄ ◄ ◄ ◄ ◄ ◄ ◄ Press. release
SK21 1600 +100/- 20 ◄ ◄ ◄ ◄ ◄ ◄ --- --- Steam intake
SK22 1300 + 20/- 50 ◄ ◄ ◄ ◄ ◄ ◄ --- --- Press. release
SK21 1600 +100/- 20 --- --- ◄ ◄ ◄ ◄ --- --- Steam intake
SK22 1300 + 20/- 50 --- --- ◄ ◄ ◄ ◄ --- --- Press. release
SF12 500 + 30/- 30 ◄ ◄ ◄ ◄ ◄ ◄ 300 ◄ Evacuation 2
SF13 1600 +100/- 20 ◄ ◄ ◄ ◄ ◄ ◄ ◄ ◄ Steam intake
SF21 1300 + 20/- 50 ◄ ◄ ◄ ◄ ◄ ◄ ◄ ◄ Press. release
SF22 180 + 30/- 30 ◄ ◄ ◄ ◄ ◄ ◄ 200 ◄ Evacuation
SF23 1800 +100/- 20 ◄ ◄ ◄ ◄ ◄ ◄ ◄ ◄ Steam intake
SF31 1300 + 20/- 50 ◄ ◄ ◄ ◄ ◄ ◄ --- --- Press. release
SF32 200 + 30/- 30 ◄ ◄ ◄ ◄ ◄ ◄ --- --- Evacuation
SF33 1900 +100/- 20 ◄ ◄ ◄ ◄ ◄ ◄ --- --- Steam intake
SF41 1300 + 20/- 50 --- --- ◄ ◄ ◄ ◄ --- --- Press. release
SF42 400 + 30/- 30 --- --- ◄ ◄ ◄ ◄ --- --- Evacuation
SF43 1700 +100/- 20 --- --- ◄ ◄ 1500 ◄ --- --- Steam intake
SH01 2750 + 60/- 60 ◄ ◄ ◄ ◄ 1850 ◄ ◄ ◄ Hold steam in-
take
SH02 2850 + 60/- 60 ◄ ◄ ◄ ◄ 1950 ◄ ◄ ◄ Hold control
SS01 3080 + 60/- 60 ◄ ◄ ◄ ◄ 2080 ◄ ◄ ◄ Steriliz. entry
SS02 3170 + 60/- 60 ◄ ◄ ◄ ◄ 2150 ◄ ◄ ◄ Sterilization
SA00 1300 + 20/- 50 ◄ ◄ ◄ ◄ 1300 ◄ ◄ ◄ Press. release
Key:
◄ As in Universal-Program
1 - Conditioning
2 - Fractionation

Empty chamber test

The coldest point in the sterilization chamber during the empty chamber test lies directly on the temperature sensor (see
circular marking in the following figure). The temperature in the rest of the sterilization chamber is almost the same all
over (0.6 K range).

Schematic side and fore view of the sterilization chamber

27
 6 Technical tables

Pressure-time charts
Universal-Program, 134 °C and 2.1 bar

Pressure
(mbar)

Quick-Program B, 134 °C and 2.1 bar

Pressure
(mbar)

28
 6 Technical tables

Quick-Program S, 134 °C and 2.1 bar

Pressure
(mbar)

Gentle-Program, 121 °C and 1.1 bar

Pressure
(mbar)

29
 6 Technical tables

Prion-Program, 134 °C and 2.1 bar

Pressure
(mbar)

30
 Certificate of Suitability
According to the recommendations of the Commission for Hospital Hygiene and
Infection Prevention at the Robert Koch Institute

Manufacturer: MELAG Medizintechnik GmbH & Co. KG

Address: Geneststraße 6-10
10829 Berlin
Country: Germany
Product: Vacuklav® 40 B+/Vacuklav® 44 B+
Type of device: Steam sterilizer
Classification: Class IIb
Device type acc. to EN 13060: Type B

We herewith declare that the above designated product is suited for sterilization of

▪ Solid instruments (wrapped and unwrapped)

▪ Porous goods (wrapped and unwrapped)
▪ Products with narrow lumen (wrapped and unwrapped)
▪ Simple hollow items (wrapped and unwrapped)

Instructions on load quantities and loading variants are specified in the user manual
and must be observed.
Be sure to observe the manufacturer’s instructions for medical devices intended for
sterilization according to EN ISO 17664-1.

We herewith declare that the following test system is suited for testing the above cited
steam sterilizer.

▪ MELAcontrol® Helix and MELAcontrol® Pro

Berlin, 01.08.2023

Dr. Steffen Gebauer

(Management)
 TH_Evo_40B+_44B+_EN.pdf | Rev. 5 - 23/2200 | Modification date: 2023-08-30
MELAG Medizintechnik GmbH & Co. KG
Geneststraße 6-10
10829 Berlin
Germany
Email: info@melag.com
Web: www.melag.com
Original instructions

Responsible for content: MELAG Medizintechnik GmbH & Co. KG

We reserve the right to technical alterations

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